WO2025259894A1 - Systèmes et procédés d'interruption de l'activité nerveuse destinés à traiter un problème médical - Google Patents

Systèmes et procédés d'interruption de l'activité nerveuse destinés à traiter un problème médical

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Publication number
WO2025259894A1
WO2025259894A1 PCT/US2025/033382 US2025033382W WO2025259894A1 WO 2025259894 A1 WO2025259894 A1 WO 2025259894A1 US 2025033382 W US2025033382 W US 2025033382W WO 2025259894 A1 WO2025259894 A1 WO 2025259894A1
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WO
WIPO (PCT)
Prior art keywords
electrodes
catheter
nerve
needle assembly
needle
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
PCT/US2025/033382
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English (en)
Inventor
Tyler MELTON
Byron Smith
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Corveus Medical Inc
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Corveus Medical Inc
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Publication date
Application filed by Corveus Medical Inc filed Critical Corveus Medical Inc
Publication of WO2025259894A1 publication Critical patent/WO2025259894A1/fr
Pending legal-status Critical Current
Anticipated expiration legal-status Critical

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
    • A61B18/14—Probes or electrodes therefor
    • A61B18/1492—Probes or electrodes therefor having a flexible, catheter-like structure, e.g. for heart ablation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
    • A61B18/14—Probes or electrodes therefor
    • A61B18/1477—Needle-like probes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/24—Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
    • A61B5/25—Bioelectric electrodes therefor
    • A61B5/279—Bioelectric electrodes therefor specially adapted for particular uses
    • A61B5/294—Bioelectric electrodes therefor specially adapted for particular uses for nerve conduction study [NCS]
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/24—Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
    • A61B5/316—Modalities, i.e. specific diagnostic methods
    • A61B5/388—Nerve conduction study, e.g. detecting action potential of peripheral nerves
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/68—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
    • A61B5/6846—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive
    • A61B5/6847—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive mounted on an invasive device
    • A61B5/6852—Catheters
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00315—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for treatment of particular body parts
    • A61B2018/00345—Vascular system
    • A61B2018/00404—Blood vessels other than those in or around the heart
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00315—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for treatment of particular body parts
    • A61B2018/00434—Neural system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00315—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for treatment of particular body parts
    • A61B2018/00505—Urinary tract
    • A61B2018/00511—Kidney
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00571—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for achieving a particular surgical effect
    • A61B2018/00577—Ablation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00636—Sensing and controlling the application of energy
    • A61B2018/00773—Sensed parameters
    • A61B2018/00839—Bioelectrical parameters, e.g. ECG, EEG
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
    • A61B18/14—Probes or electrodes therefor
    • A61B2018/1467—Probes or electrodes therefor using more than two electrodes on a single probe
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
    • A61B18/14—Probes or electrodes therefor
    • A61B2018/1475—Electrodes retractable in or deployable from a housing

Definitions

  • Heart failure affects over 6 million subjects.
  • heart failure is characterized by muscle weakening, resulting in inefficient cardiac pump action.
  • forward blood flow in some instances of heart failure is poor, which can cause a backup of blood and an accumulation of pressure in the heart and pulmonary circuit.
  • intracardiac blood pressure may increase, leading to symptoms, such as an onset of congestion, shortness of breath, and/or respiratory failure.
  • traditional methods for relieving pressure volume burden on the cardiopulmonary circuit includes removing the fluid buildup (e.g., fluid within blood vessels and tissues), thereby potentially relieving heart failure symptoms.
  • a system includes a catheter defining a lumen and an exit port, and carrying a first set of electrodes and a second set of electrodes, the exit port being disposed between the first set and second set of electrodes.
  • the catheter can be configured to be inserted through an azygous vein of a subject and into an intercostal vein branching off the azygous vein such that the first set of electrodes are disposed within the intercostal vein adjacent a splanchnic nerve of the subject and the second set of electrodes are disposed within the azygous vein.
  • the system can include an ablation probe configured to be slidably disposed within the lumen and advanceable through the exit port of the catheter to pierce at least one of the azygous vein or the intercostal vein and ablate the splanchnic nerve, the first set of electrodes and the second set of electrodes being configured to at least one of deliver stimulation energy or detect a resultant signal in response to stimulation energy.
  • a method of treating or preventing heart failure or a symptom thereof in a subject can include inserting a first set of electrodes through an azygos vein and into an intercostal vein of the subject such that the first set of electrodes are disposed in the intercostal vein adjacent a splanchnic nerve of the subject, inserting a second set of electrodes through the azygos vein such that the second set of electrodes are disposed in the azygos vein adjacent the splanchnic nerve; delivering with the first set of electrodes or the second set of electrodes stimulation energy to splanchnic nerve; measuring a resultant signal in response to the stimulation energy with the second set of electrodes when the first set of electrodes delivered the stimulation energy and with the first set of electrodes when the second set of electrodes delivered the stimulation energy; determining a position of at least one of the first set of electrodes or the second set of electrodes relative to the splanchnic nerve based on the resultant signal; and based on the position
  • a system comprises a catheter configured to be disposed in a vein of a subject, the catheter defining a lumen and an exit port; a first pair of electrodes disposed on a distal portion of the catheter and configured to deliver stimulation energy; a second pair of electrodes disposed on the catheter distal to the first pair of electrodes and configured to detect a resultant signal in response to the stimulation energy; and an ablation probe configured to be slidably disposed within the lumen and advanceable through the exit port at a non-zero angle relative to a longitudinal axis of the catheter and toward a target nerve, the ablation probe configured to deliver ablation energy to the target nerve.
  • FIG. 1 provides an exemplary flow chart depicting a method for treating a medical condition according to an embodiment described herein.
  • FIG. 2 depicts an exemplary first embodiment of a device used for treating a medical condition as described herein.
  • FIG. 3 depicts an exemplary needle assembly of the device according to FIG. 2 prior to being bifurcated.
  • FIG. 4 depicts an exemplary needle assembly of the device according to FIG. 2 after being bifurcated.
  • FIG. 5 depicts an exemplary embodiment of the device according to FIG. 2 with the needle assembly extending towards a target nerve.
  • FIG. 6 depicts an exemplary embodiment of the device according to FIG. 2 with the needle assembly extending towards a target nerve in a bifurcated configuration.
  • FIG. 7 depicts an exemplary second embodiment of a device used for treating a medical condition as described herein.
  • FIG. 8 depicts an exemplary needle assembly of the device according to FIG. 7 prior to being bifurcated.
  • FIG. 9 depicts an exemplary needle assembly of the device according to FIG. 7 after being bifurcated.
  • FIG. 10 depicts an exemplary embodiment of the device according to FIG. 7 prior to inflation of a balloon.
  • FIG. 11 depicts an exemplary embodiment of the device according to FIG. 7 are inflation of a balloon.
  • FIG. 12 depicts an exemplary embodiment of the device according to FIG. 7 with a needle assembly that has punctured through a vein wall.
  • FIG. 13 depicts an exemplary embodiment of the device according to FIG. 7 with a bifurcated needle assembly extending towards a target nerve.
  • FIG. 14 depicts an exemplary third embodiment of a device used for treating a medical condition as described herein.
  • FIG. 15 depicts an exemplary needle assembly of the device according to FIG. 14.
  • FIG. 16 depicts an exemplary embodiment of the device according to FIG. 14 with a needle assembly that has punctured through a vein wall.
  • FIG. 17 depicts an exemplary embodiment of the device according to FIG. 14 with a needle assembly extending towards a target nerve.
  • FIG. 18 depicts an exemplary fourth embodiment of a device used for treating a medical condition as described herein.
  • FIG. 19 depicts an exemplary embodiment of the device according to FIG. 18 with an ultrasound device.
  • FIG. 20 depicts an exemplary embodiment of the device according to FIG. 18 with an ultrasound device and expanded expandable balloon.
  • FIGS. 18-21 provide an exemplary method for treating a medical condition, according to an embodiment described herein, wherein various options, such as different ablation modalities, are provided.
  • FIG. 22 provides an exemplary depiction of the location of the greater splanchnic nerve relative other identifiers.
  • FIG. 23A depicts an exemplary device used for treating a medical condition as described herein.
  • FIG. 23B depicts an exemplary device used for treating a medical condition as described herein with the needle assembly extended.
  • FIG. 24A depicts a high magnification cross-sectional view of an exemplary device used for treating a medical condition as described herein.
  • FIG. 24B depicts a cross sectional view of an exemplary device used for treating a medical condition as described herein.
  • FIG. 25A depicts an exploded view of the needle assembly of an exemplary device used for treating a medical condition as described herein.
  • FIG. 25B depicts the needle assembly of an exemplary device used for treating a medical condition as described herein.
  • FIG. 26A depicts an exploded view of the needle assembly of an exemplary device used for treating a medical condition as described herein.
  • FIG. 26B depicts the needle assembly of an exemplary device used for treating a medical condition as described herein.
  • FIG. 27A depicts a cross sectional view of the needle assembly of an exemplary device used for treating a medical condition as described herein.
  • FIG. 27B depicts a longitudinal cross-sectional view of the needle assembly of an exemplary device used for treating a medical condition as described herein.
  • FIG. 28 depicts an exemplary second catheter tip of an exemplary device used for treating a medical condition as described herein.
  • FIG. 29A depicts a second exemplary needle assembly of an exemplary device used for treating a medical condition as described herein.
  • FIG. 29B depicts an exploded view of a second exemplary needle assembly of an exemplary device used for treating a medical condition as described herein.
  • FIGS. 30A-30B depict an example of a catheter used for treating a medical condition as described herein.
  • FIG. 31 depicts an image of treating a medical condition as described herein.
  • FIG. 32 depicts a graph of compound action potential (CAP) before and after nerve ablation.
  • FIG. 33A depicts an example of a device used for treating a medical condition as described herein engaging a splanchnic nerve, according to an embodiment.
  • FIG. 33B depicts the device of FIG. 33A disposed within a subject’s body, according to an embodiment.
  • FIG. 34 depicts nerve activity of a target nerve measured at a pair of sensing electrodes in response to a stimulation pulse before and after ablation of the target nerve.
  • treating heart failure or a symptom thereof may be accomplished by means of nerve ablation to a branch of the splanchnic nerve, and that such an alternative treatment may improve upon the current medication-based standard of care for heart failure patients. It is further appreciated by the inventors that the current medication-based standard of care is inadequate for a number of heart failure patients, and that treatment of heart failure can be improved by nerve ablation.
  • a common symptom of heart failure includes increased intracardiac blood pressure and accumulation of blood within the cardiopulmonary circuit, and if a subject is suffering from late state heart failure, it may take too long for the standard of care medications to reduce the intracardiac pressure to prevent hospitalization, for example, due to low bioavailability of medications, or the significant time required to pharmacologically reduce fluid build-up within the body.
  • Other patients who are prescribed standard of care medications to reduce the intracardiac pressure may be unresponsive the medications, may not be able to take certain medications due to drug interactions or other comorbidities, or may require non-standardized dosages of medications to achieve efficacy, all of which may limit the efficacy of the medications.
  • subjects suffering from early-stage heart failure may not meet the criteria for hospitalization to treat heart failure and may be denied hospitalization until such time as their condition becomes critical.
  • Almost any heart failure patient could benefit from a non-medicati on-based approach treating heart failure or a symptom thereof, and especially patients who are at risk of worsening heart failure but who do not yet meet hospitalization criteria, for example, patients rated between 2-3 on the New York Heart Association 1-4 rating scale.
  • Nerve ablation of the greater splanchnic nerve can inactivate aspects of the sympathetic nervous system, reduce intracardiac blood pressure and accumulation of blood within the cardiopulmonary circuit, and reduce the likelihood that a heart failure patient will require hospitalization, without requiring pharmacological intervention.
  • current devices and methods for ablation of the greater splanchnic nerve may utilize electrode assemblies which are prone to failure, or which may lead to unnecessary trauma to vascular tissue and surrounding tissues relative to what is required to nerve ablation.
  • current methods for the destruction of the greater splanchnic nerve may include an open-heart surgery, requiring opening of the sternum, reflection of vital organs (including heart and lung) to reach the splanchnic nerve, and physically lysing the nerve with a scalpel or other device.
  • Such a procedure is highly invasive, and places increased strain upon the subject’s heart, which is unacceptable for a subject already suffering from heart failure.
  • Another method used for ablation of the greater splanchnic nerve include piercing a subj ect’ s back with a needle, driving the needle through the subj ect’ s aorta and to access the greater splanchnic nerve, which places considerable risks on surrounding organs, including the lung, heart, and aorta.
  • non-telescopic electrode assemblies utilized for nerve ablation may induce sharp force trauma to the vascular tissue, and tissues surrounding the target nerve.
  • aspects disclosed herein provide for nerve ablation catheter devices comprising improved needle assemblies which can be used to access the greater splanchnic nerve through the vascular system of the subject, and which do not require piercing the aorta with a needle in order to access the greater splanchnic nerve.
  • Such devices may be especially useful in carrying out the methods of treating heart failure or a symptom described herein by permitting nerve ablation to a branch of the splanchnic nerve in a less invasive manner which does not place an increased strain upon the subject’s heart, and which minimizes sharp force trauma to the vascular tissue, and tissues surrounding the target nerve.
  • Such improved needle assemblies may also be easier to manufacture and experience a reduced rate of error due to the prevention of adhesion of tissue to inner surfaces of the needle assembly.
  • aspects disclosed herein provide a method of treating or preventing heart failure or a symptom of heart failure in a subject in need thereof comprising: inserting a catheter into a vascular lumen defined by a vascular tissue of the subject; guiding the catheter towards a location proximal to a target nerve, the target nerve comprises the greater splanchnic nerve; piercing the vascular tissue of the subject with a telescopic needle assembly extending outwards from the catheter towards the target nerve, the needle assembly comprises an electrode assembly, with the telescopic needle assembly having a first section surrounding a second section, wherein the second section extends outwards from the first section; delivering a stimulation energy to the target nerve with the electrode assembly; thereby fully or partially ablating the target nerve and treating or preventing heart failure or a symptom of heart failure in the subject.
  • treating or preventing heart failure or a symptom of heart failure in the subject comprises reducing intracardiac blood pressure, or reducing an accumulation of blood within a cardiopulmonary circuit of the subject.
  • the method further includes: delivering a preliminary stimulation energy to the target nerve prior to piercing the vascular tissue of the subject, or delivering a preliminary stimulation energy to the target nerve after piercing the vascular tissue of the subject, or combinations thereof; measuring a physiological response corresponding to the preliminary stimulation energy, thereby indicating whether the location proximal to the target nerve is in sufficient proximity to the target nerve.
  • the physiological response comprises nerve activity, muscle movement, cardiac activity, adverse changes in pulmonary capillary wedge pressures (PCWP), gastrointestinal changes including increased motility, increase or decrease in less palmer sweating, increase or decrease in temperature for rectal and/or skin measurement, increase or decrease in renal output in relation to changes in vascular dilation, decrease in metabolism, decreased glucose release, decreased glucagon release, or increases in brain natriuretic peptide.
  • the physiological response comprises measurement of action potential through the target nerve.
  • an insufficient physiological response corresponding to the preliminary stimulation energy is measured, indicating the location proximal to the target nerve is not in sufficient proximity to the target nerve.
  • the method further includes re-guiding the catheter towards a second location proximal to a target nerve, the second location is in closer proximity to the target nerve than the first location.
  • a sufficient physiological response corresponding to the preliminary stimulation energy is measured, indicating the location proximal to the target nerve is in sufficient proximity to the target nerve.
  • the stimulation energy sufficient to ablate the target nerve comprises electrical stimulation.
  • delivering a stimulation energy to the target nerve with the electrode assembly sufficient to ablate the target nerve comprises heating the target nerve, or a portion thereof, to about 50, 55, 60, 65, 70, 75, 80, 85, or 90 C.
  • the method further includes orientating the catheter within the vascular tissue of the subject such that it is in a direction that aligns the needle assembly with the target nerve. In some embodiments, the method further includes orientating the catheter within the vascular tissue of the subject such that it is in a direction that aligns the needle assembly with the target nerve using a radiographic marker. In some embodiments, orientating the catheter comprises orientating the needle assembly in a direction that aligns the electrode assembly with the target nerve. In some embodiments, orientating the catheter comprises rotating the catheter such that the needle assembly extends from the catheter to the target nerve.
  • the method further includes: delivering a confirmatory stimulation energy following ablating the target nerve; measuring a physiological response, or a change in physiological response, corresponding to the confirmatory stimulation energy, thereby confirming an interrupted nerve activity of the target nerve. In some embodiments, a physiological response corresponding to the confirmatory stimulation energy is measured, indicating the ablating the target nerve was unsuccessful. In some embodiments, the method further includes delivering the stimulation energy to the target nerve with the electrode assembly, thereby repeating ablating the target nerve. In some embodiments, the target nerve is a greater splanchnic nerve. In some embodiments, the target nerve is a left branch, a right branch, a lesser branch, or a least branch of the greater splanchnic nerve.
  • guiding the catheter towards the location proximal to the target nerve comprises guiding the catheter towards the ninth thoracic vertebra (T9), the tenth thoracic vertebra (T10), the eleventh thoracic vertebra (Ti l), the twelfth thoracic vertebra (T12), or the first lumbar vertebra (LI).
  • the stimulation energy is from about 10 W to about 100 W. In some embodiments, the stimulation energy is from about 25 W to about 75 W. In some embodiments, the stimulation energy is about 30, 35, 40, 45, 50, 55, 60, 65, or 70 W. In some embodiments, the stimulation energy is about 50 W.
  • vascular catheter comprising: a longitudinal axis; a distal end; a proximal end; a catheter shaft comprising an exit port; a needle assembly lumen comprising a telescopic needle assembly configured to extend through the exit port and puncture vascular tissue in contact with the catheter, the needle assembly comprises one or more electrodes configured to deliver electrical energy to a tissue in contact with the one or more electrodes, wherein the telescopic needle assembly comprises a first section surrounding a second section, wherein the second section extends outwards from the first section; a guidewire lumen; and a catheter tip.
  • the vascular catheter further comprises a contrast lumen.
  • the exit port is positioned on a lateral side of the catheter shaft.
  • the catheter further includes an electrical surface on the needle assembly.
  • the catheter further includes a base electrode on an outer surface of the catheter.
  • the base electrode is positioned within 0-90 degrees radially of a location on the outer surface of the vascular catheter relative to the longitudinal axis of the vascular catheter on an outer surface thereof.
  • the catheter further includes a plurality of base electrodes on an outer surface of the catheter.
  • the catheter further includes a first electrical circuit electrically coupled to the one or more electrodes.
  • the catheter further includes a second electrical circuit electrically coupled to the base electrode.
  • the catheter is configured to provide electrical energy of differing frequencies to the first electrical circuit and the second electrical circuit.
  • the needle assembly comprises: one or more tubular bodies; a distal point; a first electrode; a second electrode; a wire connecting the first electrode and the second electrode to a power source; an insulating material insulating the first electrode, the second electrode, and the wire from the vascular catheter.
  • the wire comprises an enamel coated wire or a multistrain braid.
  • the first section comprises a first tubular body
  • the second section comprises a second tubular body
  • the first tubular body extends outward from the second tubular body
  • the first tubular body nests within the second tubular body such that the tubular body is fully or partially contained within the first tubular body.
  • the needle assembly further comprises a third section comprising a sharp distal point, wherein the second section surrounds the third section, wherein the third section extends outward from the second section.
  • the first electrode is positioned on the first tubular body
  • the second electrode is positioned on the second tubular body.
  • the first electrode and the second electrode are positioned on the first tubular body, or the second tubular body.
  • the needle assembly further comprises an electrically insulating material within the needle assembly, the electrically insulating material comprises a dielectric insulator between the first and second tubular bodies. In some embodiments, the needle assembly further comprises an electrically insulating material within the needle assembly, the electrically insulating material comprises an insulator or a dielectric washer positioned between the first and the second tubular bodies along a circular cross section of the first tubular body or the second tubular body. In some embodiments, the one or more electrodes comprises only a single electrode. In some embodiments, the one or more electrodes comprises two electrodes. In some embodiments, the one or more electrodes comprises three electrodes.
  • the three electrodes are arranged such that the second electrode is between the first and third electrodes, and wherein the second electrode is a negative electrode and the first and third electrodes are positive electrodes, or wherein adjacent electrodes have opposite polarity. In some embodiments, the three electrodes are arranged such that the second electrode is between the first and third electrodes the second electrode is a positive electrode with the first and third electrodes being negative electrodes. In some embodiments, the catheter is configured to permit ablation between the first and second electrode, or the second and third electrode. In some embodiments, the needle assembly further comprises an electrically insulating material within the needle assembly. In some embodiments, the electrically insulating material comprises a dielectric, a dielectric washer, or a polyimide liner.
  • the needle assembly when the needle assembly further comprises a third electrode. In some embodiments, when the needle assembly further comprises separate electrical circuits for each electrode. In some embodiments, when the needle assembly extends a prescribed distance from the exit port and is in proximity to a target nerve and energized, the vascular catheter is configured to ablate a length of the target nerve that is at least as long as or longer than the deployed distance between the first and second tubular bodies. In some embodiments, the insulating material comprises a dielectric washer. In some embodiments, the first electrode and the second electrode are electrically isolated from each other. In some embodiments, the needle assembly is configured to deliver an electric charge in a bipolar manner.
  • the first electrode and/or the second electrode are in operative communication with a controller configured to modulate a power delivered by a source of energy.
  • the one or more electrodes comprises a silk-screened electrode.
  • the one or more electrodes comprises an additive manufactured electrode.
  • the one or more electrodes comprises a subtractive manufactured electrode.
  • the catheter further includes a base at the proximal end of the vascular catheter configured to permit for manipulation of the vascular catheter.
  • the catheter further includes a vascular catheter rotation knob configured to rotate the vascular catheter.
  • the catheter further includes a rotary electrical connector configured to rotate the catheter or the needle assembly.
  • the catheter further includes a rotary electrical connector configured to rotate the catheter, the needle assembly, the guidewire port, or the contrast port. In some embodiments, the catheter further includes a rotary electrical connector configured to rotate the catheter or the rotational control knob. In some embodiments, the catheter further includes a rotation coupler configured to rotate the vascular catheter. In some embodiments, the catheter further includes an electrode advancer configured to extend the needle assembly and one or more electrodes through the exit port. In some embodiments, the catheter further includes a guidewire port. In some embodiments, the catheter further includes a contrast port. In some embodiments, the catheter further includes a dielectric material insulating the one or more electrodes from the vascular catheter. In some embodiments, the dielectric material comprise polyimide.
  • the vascular catheter shaft comprises braid reinforced pebax, an extruded material, nylon, a fibrous material, wire, a multi strain braid, or a material configured to transfer force through a longitudinal axis.
  • the needle assembly further comprises one or more marker bands.
  • the marker bands are configured to provide an indication as to positioning of the catheter relative to a vein, with fluoroscopic imaging, or indicate a relative position of the catheter within a vein, artery, or vessel.
  • the needle assembly further comprises a bifurcated configuration comprising a second tubular body terminating in a sharp point, the first and second tubular bodies are spaced apart when the needle assembly is extended, the first electrode is on the first tubular body, and the second electrode is on the second tubular body.
  • the nerve activity interruption triggers a response for treating the medical condition, including alleviating symptoms of said medical condition.
  • the nerve activity interruption comprises destroying a portion of one or more target nerves.
  • destroying the portion of one or more target nerves comprises targeting the target nerve at one or more different locations to enable such destruction.
  • a bifurcated needle assembly having two needles e.g., needle electrodes as described herein, wherein the tips of each needle are spaced apart
  • a device e.g., a catheter-based device
  • the location of the target nerve is confirmed via any combination of fluoroscopy, neurostimulation, and/or nerve sensing to ensure accurate ablation of the target nerve.
  • neurostimulation enables real-time or substantially real time confirmation of a target nerve location.
  • the medical condition comprises heart failure, such as inefficient cardiac pump action, wherein interruption of a target nerve (e.g., denervation of a target nerve), such as the splanchnic nerve, enables for cardiac blood pressure to be alleviated by removing fluid within blood vessels and tissues (e.g., blood buildup in the heart) and sending said removed fluid to the abdominal cavity.
  • a target nerve e.g., denervation of a target nerve
  • systems, devices, and methods described herein are used to treat a medical condition.
  • the medical condition comprises heart failure, constipation, metabolic syndrome (including obesity), hyperhidrosis, hypertension, or others known in the art to be affected by nerve activity interruption of one or more target nerves, or a combination thereof.
  • Heart failure affects over 6 million subjects.
  • heart failure is characterized by muscle weakening, resulting in inefficient cardiac pump action.
  • forward blood flow in some instances of heart failure is poor, which can cause a backup of blood and an accumulation of pressure in the heart and pulmonary circuit.
  • intracardiac blood pressure may increase, leading to symptoms, such as an onset of congestion, shortness of breath, and/or respiratory failure.
  • traditional methods for relieving pressure volume burden on the cardiopulmonary circuit is by removing fluids within blood vessels and tissues (e.g., fluid buildup, such as blood,), thereby potentially relieving heart failure symptoms.
  • subjects are in a state of compensated heart failure, where there are no cardiopulmonary pressures or symptoms.
  • cardiac recovery for such state of compensated heart failure occurs with the aid of medications.
  • subjects are caught in a vicious cycle of volume accumulation, hospitalization for fluid removal, and discharge, wherein cardiac recovery does not occur. In some instances, such subjects do not respond to conventional medications.
  • systems, methods, and devices described herein are configured to provide a mechanical reduction of intracardiac blood pressures, for example via the redistribution of fluid (e.g., blood) away from the heart, so as to relieve intracardiac pressures.
  • fluid e.g., blood
  • fluid e.g., blood
  • the abdominal cavity has a high vascular capacity to absorb fluid.
  • the vascular capacity is determined by a variety of factors, including autonomic nerve activity.
  • Some of the sympathetic nerves that innervate the abdominal cavity include splanchnic nerves, wherein splanchnic nerves originate from the sympathetic chain in the thoracic cavity, and travel to the abdominal cavity, where they synapse on various ganglia.
  • Sympathetic splanchnic nerve activity results in vascular vasoconstriction in the abdominal cavity.
  • systems, methods, and devices described herein are configured to inactivate the sympathetic nerve activity (splanchnic nerves) to vasodilate the splanchnic vasculature, and thereby draw fluid to the abdominal cavity.
  • splanchnic nerves sympathetic nerve activity
  • such plurality of types comprise percutaneous means, transvascular means, and/or surgical means.
  • FIG. 1 provides an exemplary method for reducing cardiac blood pressure by redistributing fluid (e.g., blood) from the heart to one or more cavities.
  • the method comprises interrupting nerve activity (e.g., denervation) of one or more target nerves.
  • the one or more target nerves is first identified and/or confirmed through one or more sensing techniques described herein, after which the nerve activity of the one or more target nerves is then interrupted.
  • a device described herein e.g., a catheter-based device
  • the one or more target nerves comprise a splanchnic nerve, lumbar sympathetic nerve, sympathetic stellate ganglion, other target nerves known in the art, or any combination thereof.
  • a splanchnic nerve enables treatment for heart failure (as described herein).
  • branches of the splanchnic nerve include the greater splanchnic nerve (GSN), the lesser splanchnic nerve, and the least splanchnic nerve, any of which (in combination or singularly) may be targeted for treatment of a medical condition.
  • the GSN is a branch of the thoracic sympathetic nerve and is thus configured to provide sympathetic innervation to the abdominal cavity.
  • the GSN traverses the thoracic cavity, travels through the aortic hiatus, and synapses on the celiac ganglion, from wherein it is able to innervate several target organs, including the abdominal vasculature. As such, by inactivating the GSN, the abdominal vasculature dilates, thereby drawing in blood volume from the circulatory system. As described herein, in some instances, volume drawn from the heart will alleviate the pressure burden in the cardiopulmonary system, which can be evidenced, for example by a decreased pulmonary capillary wedge pressure (PCWP) - as described herein.
  • PCWP pulmonary capillary wedge pressure
  • targeting the lumbar sympathetic nerve allows for treatment of a peripheral artery disease.
  • targeting the sympathetic stellate ganglion allows for treatment of ventricular arrhythmias.
  • the target nerve comprises the splanchnic nerve
  • the cavity receiving the redistributed fluid comprises the abdominal cavity.
  • a location of a target nerve is first approximated, after which the target nerve is identified and/or confirmed, to ensure the correct nerve will be targeted for interruption of nerve activity to obtain the desired effect.
  • confirmation of the nerve activity interruption at the target nerve acts as an exemplary identifier that a desired effect within the subject has occurred (e.g., treatment of a medical condition, such as reduction of intracardiac blood pressure).
  • a device is used to access a target nerve (e.g., splanchnic nerve) within the subject.
  • a device described herein is used.
  • the device is a catheter-based device.
  • the device is inserted within a subject 102.
  • the device is used to access the vascular system (e.g., via femoral and/or subclavian).
  • the device accesses the vascular system so as to inactivate a sympathetic nerve activity.
  • the device accesses the vascular system via the Seidinger technique.
  • access points for the vascular system in the upper extremity comprise the jugular and/or subclavian veins.
  • access points for the vascular system in the lower extremity access comprise the femoral vein.
  • a device described herein is configured to navigate from either the jugular, subclavian, and/or femoral vein to the superior vena cava. In some embodiments, the device is navigated under fluoroscopic guidance.
  • FIG. 22 provides an exemplary depiction of splanchnic nerve and vein anatomy.
  • the device is first navigated within the subject to an approximated location of the target nerve 104.
  • such approximated location is based on using anatomic landmarks.
  • the device is guided to the approximated location of the target nerve under fluoroscopy in view of the anatomic landmarks.
  • the anatomic landmarks comprise radiopaque anatomic landmarks.
  • the device accesses the azygos vein 2202 (via an access point as described herein), a branch of the superior vena cava.
  • the device is configured to enter the left and/or right intercostal vein branch 2204.
  • the device enters the left and/or right intercostal vein branch via an anatomic landmark.
  • the anatomic landmark comprises the ninth thoracic vertebra (T9) 2208 (depicted as located behind the intersection of the greater splanchnic nerve (GSN) 2206 and left and/or right intercostal vein branch 2204), wherein an exemplary target nerve, the greater splanchnic nerve (GSN) 2206, is located nearby the T9. Accordingly, the location of the GSN can be approximated via the T9.
  • the device is further configured to confirm the location of a target nerve (e.g., the GSN) through direct nerve sensing and/or stimulating the nerve while measuring a physiologic response.
  • a target nerve e.g., the GSN
  • a device described herein in addition to or alternative to using anatomic landmarks to approximate the location of a target nerve, a device described herein will use neurosensory to approximate the location of a target nerve.
  • the device comprises a neurosensory region that is configured to detect action potential signals that will indicate the presence of a nerve nearby (to the device).
  • the neurosensory region comprises one or more neurosensory electrodes.
  • a device described herein is configured to stimulate the target nerve so as to elicit a nerve response, such that the location and/or identification of a target nerve may be confirmed 106.
  • the device comprises a neurostimulation component to stimulate the target nerve.
  • the device is configured to deliver an electric charge to a subject via the neurostimulation component so as to elicit a nerve response from a target nerve (e.g., GSN).
  • the neurostimulation component is configured to deliver the charge through one or more neurostimulation electrodes.
  • the neurostimulation component e.g., one or more neurostimulation electrodes
  • the neurostimulation component is configured to deliver the electric charge within a vessel (e.g., within a vein, artery, or vessel) and/or outside a vessel (e.g., vein).
  • the physiological response from the stimulation is measured and/or recorded.
  • the device is configured to puncture through a vessel (e.g., vein) and position the one or more neurostimulation electrodes so as to contact the target nerve or place the neurostimulation electrodes in close proximity of the target nerve to deliver the charge and such one or more recording electrodes are configured to measure the physiological response.
  • the device is configured to deliver a charge strong enough to elicit a nerve response, but not strong enough to damage tissue (e.g., target nerve tissue and/or surrounding tissue).
  • tissue e.g., target nerve tissue and/or surrounding tissue.
  • proximity of the device location to the target nerve is confirmed by eliciting one or more sympathetic nerve responses via delivering said electric charge and confirming the location 107.
  • such sympathetic nerve responses indicating a desired location may be detected via a measured physiological response.
  • examples of detecting a sympathetic response of the GSN via a measured physiological change include detecting adverse changes in pulmonary capillary wedge pressures (PCWP) (e.g., increase in PCWP), gastrointestinal changes including increased motility, changes in less palmer sweating, abnormal changes in temperature for rectal and/or skin measurement, in renal output in relation to changes in vascular dilation, changes in metabolism (i.e. decreased glucose and glucagon release), and/or increases in brain natriuretic peptide.
  • PCWP pulmonary capillary wedge pressures
  • gastrointestinal changes including increased motility changes in less palmer sweating
  • abnormal changes in temperature for rectal and/or skin measurement in renal output in relation to changes in vascular dilation
  • changes in metabolism i.e. decreased glucose and glucagon release
  • increases in brain natriuretic peptide i.e. decreased glucose and glucagon release
  • a device described herein is configured to detect and measure any of such indicators for a sympathetic response.
  • PCWP is obtained with right heart catheter procedures that are routinely performed in the hospital.
  • An example of such right heart catheter procedure comprises of a percutaneous access of a catheter through the jugular vein (for example, by using the Seidinger technique) in a sterile fashion.
  • the catheter (for obtaining PCWP) comprises the Swan Ganz catheter, which may have a balloon.
  • the balloon of the Swan Ganz catheter is inflated, and is threaded through to the superior vena cava, the right atrium, and the right ventricle to the pulmonary outflow tract.
  • the inflated balloon carries the catheter to a pulmonary artery, where it is wedged, and where pressures detected are called pulmonary capillary wedge pressures.
  • the PCWP are considered equivalent to left atrial pressures.
  • left atrial pressures are a surrogate measurement for left ventricular end-diastolic pressures.
  • PCWP is a measurement of a severity of heart failure, wherein higher PCWP indicates worsened severity of heart failure.
  • determining if the device is in a desired location can include measuring the physiological response in response to the stimulation and if one or more parameters indicates that the device is in a desired location.
  • the one or more parameters can include nerve activity and/or electrical impedance.
  • certain values associated with the nerve activity and/or electrical impedance can indicate that device is in a desired location and/or outside of a desired location.
  • the neurosensory region in addition to or alternate to detecting a physiological response for confirming the location of a target nerve, can be used to confirm the location of a target nerve via detecting action potentials from the target nerve.
  • detection for each of the other responses elicited through stimulation of a target nerve will be measured by a device described herein and/or other respective devices and methods known in the art.
  • a device described herein e.g., a catheter device
  • a nerve e.g., target nerve
  • the device is configured to directly sense the target nerve via a neurosensory region as described herein, which may contain one or more neurosensory electrodes.
  • the one or more neurosensory electrodes and one or more neurostimulation electrodes are separate sets of electrodes.
  • the one or more neurostimulation electrodes are also be configured to function as neurosensory electrodes.
  • the device is further configured to change from a neurosensory mode to a neurostimulation mode for stimulating at target nerve.
  • a method as described herein comprises placing the device to said neurosensory mode upon being positioned proximate to the GSN (for example, via the T9 landmark) to confirm the presence of a nerve nearby (to the device),
  • the device is configured to operate in a neurosensory mode and a neurostimulation mode simultaneously.
  • the device when in the neurosensory mode, uses the electrodes and/or another component to detect action potentials, signifying the presence of a nerve nearby.
  • a device described herein e.g., catheter-based device
  • data from the neurostimulation component and/or the neurosensory component is communicated to the computing device.
  • the data from the neurostimulation component and/or the neurosensory component is aggregated to indicate that the device is in the position to perform nerve destruction for interrupting nerve activity.
  • an ablation probe e.g., needle, device, etc.
  • the ablation probe can include one or more electrodes configured to measure one or more parameters and set the measurement as a baseline value for comparison after ablation.
  • the one or more parameters can include impedance and/or nerve activity.
  • nerve activity for the target nerve is then interrupted 110.
  • such confirmation of the target nerve location comprises, for example, through a physiological response as described herein measuring a response (e.g., sympathetic response) to a stimulated target nerve 107, and/or through detecting action potentials of the target nerve.
  • confirming the location of a target nerve comprises a combination of neurostimulatory and nerve sensing functions evaluated by a software component of a computing device described herein
  • interrupting nerve activity comprises ablating the target nerve.
  • a device described herein is configured to ablate a portion of a target nerve (e.g., GSN).
  • ablation of the target nerve comprises circumferentially lysing a target nerve.
  • the device may be configured to ablate a portion of the target nerve using a plurality of different methods.
  • the device comprises a vascular puncture mechanism to perform the ablation.
  • the vascular puncture mechanism is actuated in the direction of the nerve to perform the ablation.
  • the vascular puncture mechanism is also configured to confirm the position of the device using a combination of 1) nerve-sensing, 2) neuro-stimulation with a physiological response, and/or 3) fluoroscopy identifying anatomic landmarks (e.g., the ninth thoracic vertebra (T9), the tenth thoracic vertebra (T10), the eleventh thoracic vertebra (Ti l), the twelfth thoracic vertebra (T12), or the first lumbar vertebra (LI)).
  • anatomic landmarks e.g., the ninth thoracic vertebra (T9), the tenth thoracic vertebra (T10), the eleventh thoracic vertebra (Ti l), the twelfth thoracic vertebra (T12), or the first lumbar vertebra (LI)
  • the device is configured to destroy a portion of the target nerve (portion of the GSN) using one or more of the following modalities: radiofrequency ablation, chemical ablation (carbon dioxide, ethanol, liquid nitrogen), or cryotherapy ablation.
  • a device described here in addition to or alternate to ablating the target nerve, is configured to down regulate a portion of the target nerve.
  • destroying a portion of the target nerve corresponds to destroying a portion of the nervous tissue of the target nerve.
  • such portions of the target nerve(s) (e.g., GSN) being destroyed are able to regenerate.
  • the length of the portion of the target nerve being destroyed can be specified or predetermined.
  • the durability of effect for providing relief to a medical condition is related to the length of the nervous tissue of the target nerve destroyed.
  • the length of a target nerve (GSN) destruction is a critical factor for providing relief from heart failure symptoms, wherein destroying a longer length of the target nerve (for example via the vascular puncture mechanism, and as compared to intravascular ablation) provides for a longer duration of removal of sympathetic activity, and thereby enabling subjects to experience relief from heart failure symptoms for a longer period of time.
  • the vascular puncture (for example, using a device described herein) is configured to control the direction of the ablation modality.
  • the device is configured to target ablation of the target nerve to a specific portion and length of the corresponding nervous tissue.
  • systems, methods, and devices described herein are configured to minimize collateral damage to other organs when ablating a target nerve.
  • collateral damage to other organs when ablating a target nerve is enabled through 1) positioning one or more ablation electrodes in close proximity with a target nerve or contacting the target nerve, 2) delivering the ablation energy via a bipolar configuration (thereby helping enable to control the shape and distribution of the ablation energy (e.g., radiofrequency energy), and/or 3) reducing the ablation energy requirements to interrupt nerve activity of the target nerve.
  • the ablation energy e.g., radiofrequency energy, microwave energy
  • delivered to the target nerve is from about 0.1W to about 100W.
  • the temperature provided for ablating the target nerve is from about -200°C to about 100°C.
  • a needle assembly comprising two needles (e.g. two needle-electrodes) is used to enable a plurality of electrodes to contact or be placed in close proximity to the target nerve at two different locations, so as to enable a length of the target nerve tissue to be ablated.
  • the success of a method described herein for treating a medical condition (e.g., heart failure) via nerve interruption is determined by neuro-stimulation and detection of a physiological response (as described herein).
  • nerve-sensing e.g., measuring action potential of the target nerve
  • the device is configured to then provide neurostimulation to confirm a lack of a sympathetic response 110.
  • providing neurostimulation comprises delivering an electrical charge (e.g., via a neurostimulation component) through electrodes strong enough to elicit a nerve response, but not strong enough to damage tissue (nervous tissue or of surrounding tissue).
  • an electrical charge e.g., via a neurostimulation component
  • the presence of a sympathetic response of the GSN will then be monitored, for example via a physiological response, as described herein.
  • the presence of a sympathetic response comprises detecting adverse changes in pulmonary capillary wedge pressures (PCWP) (e.g., increase in PCWP), gastrointestinal changes including increased motility, changes in less palmer sweating, abnormal changes in temperature for rectal and/or skin measurement, in renal output in relation to changes in vascular dilation, changes in metabolism (i.e.
  • PCWP pulmonary capillary wedge pressures
  • gastrointestinal changes including increased motility, changes in less palmer sweating, abnormal changes in temperature for rectal and/or skin measurement, in renal output in relation to changes in vascular dilation, changes in metabolism (i.e.
  • a nerve-sensing component of the device will detect a lack of nerve activity (e.g., via detecting any action potentials), thereby indicating the nerve has successfully been ablated (for e.g., successfully circumferentially lysed) 112.
  • detection of decrease PCWP indicates successful ablation as blood is being drawn away from the heart to the abdominal cavity.
  • detection of a sympathetic response indicates the targeted portion of the target nerve was not successfully destroyed (e.g., ablated), and thus treatment of the medical condition may be considered as incomplete.
  • the method described herein e.g., FIG. 1 will be repeated to located and destroy a portion of the target nerve as described herein.
  • a device described herein is configured for treating a medical condition by interrupting nerve activity for one or more target nerves.
  • the device is configured to destroy a portion of the nervous tissue for the one or more target nerves (for example, via ablation).
  • the device is configured to target a specific portion of the target nerve for said destruction.
  • the device is configured to provide a neurostimulation to the target nerve, sense nerve activity from the target nerve, and/or ablate a portion of a target nerve.
  • the device comprises a catheter-based device.
  • the catheter-based device comprises a device body configured to navigate within a subject.
  • the device body comprises a radiopaque region (e.g., see reference character 204 in FIG. 2).
  • the radiopaque region enables for fluoroscopic guidance of the device within a subject.
  • the device body is in operable communication with a power supply, controller, actuator, and/or computing device for initiating an operation of the device, and/or terminating or pausing operation of the device.
  • the device is configured to be in operative communication with a power supply via a cord (e.g., a cord plugged into a power supply).
  • the device is configured to be in operative communication with a controller and/or actuator via a cord (e.g., a cord plugged into a power supply).
  • the device is configured to be in operative communication with a computing device, power supply, controller, and/or actuator via a wireless component (e.g., Bluetooth®).
  • a wireless component e.g., Bluetooth®
  • the catheter-based device comprises a vascular puncture mechanism, a mechanism to bias the catheter against the vein walls (within a subject), one or more ablation electrodes, one or more neurostimulation electrodes, a neurosensory region, or a combination thereof.
  • the vascular puncture mechanism comprises one or more needles or a needle array of varying sizes.
  • the device is configured to position the one or more ablation electrodes so as to contact the target nerve or be placed in close proximity to the target nerve.
  • the device provides neurostimulation to a target nerve using one or more neurostimulation electrodes.
  • the device is configured to sense activity of a target nerve via the neurosensory region.
  • the neurosensory region comprises one or more neurosensory electrodes.
  • the neurosensory region comprises one or more sensors configured to sense nerve activity (such as action potentials).
  • the device is configured to ablate a portion of a target nerve using one or more ablation electrodes.
  • the ablation electrode is configured to ablate at least a portion of the target nerve using radiofrequency energy, microwave energy, or a combination thereof.
  • the device is configured to ablate a portion of a target nerve without an ablation electrode (e.g., chemical ablation, cryoablation, etc.)
  • the one or more ablation electrodes, the one or more neurostimulation electrodes, and the one or more neurosensory electrodes are provided as separate electrodes on the device.
  • the one or more the ablation electrodes, the one or more neurostimulation electrodes, the one or more neurosensory electrodes, or any combination thereof comprise the same electrodes.
  • the ablation electrode, the neurostimulation electrode, the neurosensory electrode, or any combination thereof comprise the same electrode(s) or different electrode(s) based on the arrangement and/or positioning of the device body within a subject (e.g., catheter tip).
  • the device comprises a vascular puncture mechanism (e.g., vein puncture mechanism) configured to position a needle assembly (e.g., comprising a needle and electrode) so as to contact with or be in close proximity with a target nerve (as described herein).
  • the vascular puncture mechanism comprises a needle assembly configured to puncture a vein or artery.
  • the needle assembly comprises one or more needles (e.g., needle-electrode or hollow needle as described herein), configured to puncture a vein or artery.
  • the needle assembly comprises the ablation electrode, the neurosensory electrode, and/or the neurostimulation electrode.
  • the one or more ablation electrodes are disposed with the needle assembly.
  • the needle assembly is configured to extend from a device body of the device towards the target nerve.
  • the needle assembly is configured to extend from within a device body of the device (e.g., catheter-based device) and towards the target nerve (e.g., see FIGS. 2-6).
  • the needle assembly is configured to extend and puncture through a vessel wall (e.g., vein wall).
  • the needle assembly is configured to extend from the device body via a needle assembly push mechanism that can be actuated and/or moved from a location external to the subject (e.g. accessible by a user outside the subject).
  • the orientation at which the needle assembly extends through the vessel wall and towards the target nerve is adjustable by adjusting the orientation of the device body within the subject (e.g., rotating the device body).
  • radiopacity helps enable rotational accuracy for positioning the needle assembly (as described herein).
  • the radiopaque mark appears different on the catheter body at 90-degree increments, thereby helping direct the needle assembly in the superior/inferior, anterior/posterior, lateral/medial, and/or cranial/caudal directions.
  • the radiopaque appearance of the radiopaque mark under fluoroscopy changes as the device body rotates, which may help with guiding the device body and positioning the needle assembly.
  • the location on the device body at which the needle assembly extends and/or the orientation at which the needle assembly extends is correlated with a location of a 1) radiopaque mark, 2) one or more neurostimulation electrodes, and/or a 3) neurosensory region (e.g., neurosensory electrodes, neuro sensor, etc.).
  • the device body has a longitudinal axis, wherein the needle assembly is configured to extend at a non-zero angle relative to the longitudinal axis.
  • the needle assembly extends from a device body of the device in a needle tube that is disposed within a needle lumen within the device body or located externally thereto.
  • the needle tube is configured to extend until an end of the needle tube abuts a vessel wall (e.g., vein wall) or is placed in close proximity of the vessel wall.
  • the needle tube is configured to extend from the device body via a tube push mechanism that can be actuated and/or moved from a location external to the subject (e.g., pushed by a user outside the subject).
  • the needle assembly is configured to extend through an opening at the end of the tube so as to puncture through the vessel wall.
  • the needle assembly is configured to extend from the tube via a needle assembly push mechanism that can be actuated and/or moved from a location external to the subject.
  • the orientation at which the needle assembly extends through the vessel wall and towards the target nerve is adjustable by adjusting the orientation of the device body within the subject (e.g., rotating the device body).
  • the device e.g., catheter-based device
  • the device is configured to provide a staged stimulation of a target nerve.
  • the ablation electrodes are the same electrodes as the neurostimulation electrodes
  • the needle assembly is located within a needle tube
  • the device is configured to stimulate the target nerve 1) when the needle tube and needle assembly are disposed within the device body (i.e. prior to being deployed and extending from the device body), and 2) after the needle tube and needle assembly are deployed from the device body, and wherein the needle tube abuts a vessel wall.
  • the device is configured to further confirm the location of a target nerve via stimulation provided from a closer location (e.g., at the vessel wall), prior to puncture of the vessel.
  • the stimulation is provided only at the vessel wall (i.e. not a staged stimulation).
  • the device body comprises one or more lumens located therein (e.g., needle lumen as described herein).
  • the needle lumen extends within the device to an opening on the device body.
  • the opening is a lateral opening on the device body.
  • the needle lumen extends substantially parallel with a longitudinal axis of the catheter body. In some embodiments, the needle lumen curves so as to terminate at the lateral opening.
  • the needle assembly is disposed at least partially on an external portion of the device body.
  • the needle assembly is configured to be biased to a vessel wall (e.g., a vein wall) by a balloon, thereby enabling the needle assembly to puncture through the vessel wall and extend towards the target nerve (see FIGS. 7-20 for example, as described herein).
  • a vessel wall e.g., a vein wall
  • an inflatable balloon is located about at least a portion of an external surface of the device body of a device described herein (e.g., catheter-based device).
  • the needle assembly is disposed on the device body such that by inflating (or expanding) the balloon causes the needle assembly to move and be biased towards the vessel wall.
  • the needle assembly is biased towards the vessel wall, but does not puncture the vessel wall. In some embodiments, the needle assembly is biased towards the vessel wall and punctures through the vessel.
  • the balloon is inflated or expanded via known methods in the art, such as providing an inflation medium via an inflation tube in fluid communication with the inflatable balloon.
  • the inflation medium comprises air, another gas, a liquid, a saline solution, other fluids known in the art. In some embodiments, the inflation medium is provided by a source located external to the subject.
  • the needle assembly is configured to puncture through the vessel wall and extend towards the target nerve via a needle assembly push mechanism that can be actuated and/or moved from a location external to the subject.
  • the orientation at which the needle assembly extends through the vessel wall and towards the target nerve is adjustable by adjusting the orientation of the device body within the subject (e.g., rotating the device body).
  • the device body comprises one or more lumens located therein.
  • the inflation tube is located within an inflation lumen within the device body.
  • the inflation lumen extends within the device and enables fluid communication between the inflatable balloon and the inflation tube.
  • the needle assembly for any device comprises one or more needle-electrodes (e.g., see FIG. 4 and FIG. 9).
  • each needleelectrode comprises a needle stem and one or more electrodes.
  • the needle stem and one or more electrodes for each needle-electrode are integrated together as a single component.
  • the needle stem and one or more electrodes are coupled together for each needle-electrode, which may be a detachable coupling.
  • the one or more electrodes for each needle-electrode comprises one or more ablation electrodes.
  • the one or more electrodes for each needle-electrode comprises one or more ablation electrodes, one or more neurostimulation electrodes, and/or one or more neurosensory electrodes. In some embodiments, the one or more electrodes are disposed at any location on each needle-electrode. In some embodiments, at least one electrode is located on a distal end of a needleelectrode, wherein the distal end of the needle-electrode stem is in contact with or in close proximity with the target nerve (e.g., GSN), and wherein a proximal end of the needle-electrode is in contact with, within, and/or in close proximity with a device body of a device.
  • the target nerve e.g., GSN
  • At least one needle-electrode comprises a single electrode. In some embodiments, at least one needle-electrode comprises a plurality of electrodes. In some embodiments, the plurality of electrodes comprise an electrode array. In some embodiments, the electrode array is arranged in a linear configuration. In some embodiments, the electrode array comprises a plurality of electrodes spaced apart and/or electrically isolated from each other. As described herein, in some embodiments, the plurality of electrodes (e.g., ablation electrodes) are configured to provide ablation energy in a bipolar manner.
  • the needle-electrodes are configured to be constrained and/or compressed towards each other in a pre-deployed configuration (e.g., when the needle assembly is located within the device body, within a needle tube, prior to being biased against a vessel wall, prior to puncturing through a vessel wall, or any combination thereof).
  • the two or more needle-electrodes are configured to be constrained and/or compressed towards each other when navigating with the device body to a desired location near to a target nerve (e.g., GSN).
  • a target nerve e.g., GSN
  • the two or more needle-electrodes remain constrained and/or compressed towards each other in a pre-deployed configuration (e.g., non-bifurcated configuration as described herein).
  • the needle assembly is held in a pre-deployed configuration by a needle assembly tube (as described herein), wherein the needle assembly is located therein (e.g., the interior wall of the needle assembly tube constrains the needle assembly from bifurcating).
  • the two or more needle-electrodes are configured to separate from each other at a distal end as the needle assembly extends a prescribed length from the device body.
  • a needle assembly comprises two needles that are configured to bifurcate at a distal end of the needle assembly (e.g., see FIGS. 3-4 and FIGS. 8-9), thereby enabling the needle assembly to contact with or be placed in close proximity with the target nerve at two different locations the two bifurcated distal ends of the needle-electrodes.
  • the needle assembly is configured to target ablation (e.g., via radiofrequency or microwave energy using the needle-electrodes) at two or more locations of a target nerve, and thereby enable a length of the target nerve to be ablated between and/or about said two or more locations.
  • the ability of needle-electrode bifurcation enables for changing the shape of the thermal zone along the length of the target nerve, resulting in longevity of an intended benefit.
  • the distance between the tips of two needles (e.g., needleelectrodes) for a needle-assembly in a bifurcated configuration is identified as a deployed distance.
  • the term “bifurcated configuration” is used interchangeably with the term “bifurcated position”.
  • the deployed distance is from about 1mm to about 10cm.
  • the distance between the tips of two needles (e.g., needle-electrodes) for a needle-assembly in a non-bifurcated configuration is identified as a non-bifurcated distance.
  • the deployed distance is larger than the non-bifurcated distance.
  • the non-bifurcated distance is none (e.g., 0mm) or substantially none.
  • the device is configured to ablate a length of the target neve that is at least the length of the deployed distance.
  • the ablation of the target nerve comprises a full circumferential ablation of the target nerve along a given length.
  • the needle-electrodes are configured to separate (e.g., bifurcate) a prescribed length from each other at a distal end of the needle-assembly.
  • the needle-electrodes are configured to separate (e.g., bifurcate) from each other in a prescribed orientation, such that the separation (e.g. bifurcation) of the needle-electrodes (e.g., deployed distance) is aligned with a length of the target nerve.
  • the target nerve (e.g., GSN) runs perpendicular to a vein described herein, such that the needle-electrodes, when and/or after puncturing through the vein wall, will separate along an axis of the target nerve.
  • the target nerve runs parallel with the vein, such that the needle electrodes will separate along the parallel direction of the target nerve.
  • each needle-electrode of a needle assembly is electrically isolated from each other.
  • the needle-assembly is configured to deliver energy in a bipolar manner.
  • radiofrequency energy is configured to be delivered through both needle-electrodes in a bipolar manner that will be able to destroy a longer length of nerve (for e.g., as compared to ablation from within the vessel).
  • the needle assembly comprises three needles, wherein the needle assembly is configured to move from a pre-deployed configuration (as described herein) to a configuration where the tips of the three needles are spaced apart from each other.
  • the needles are configured to space apart from each other in any direction (e.g., three dimensionally), and thereby be configured to target three locations on a target nerve for ablation.
  • the needle assembly comprises one or more needle-electrodes having an electrode array disposed thereon.
  • the electrode array comprises a plurality of electrodes.
  • the plurality of electrodes are electrically isolated from each other.
  • the electrode array is arranged in linear configuration on a same side of a needle-electrode.
  • the device is configured to introduce a linear electrode array that will travel along the length of the nerve in one direction after vein puncture. The electrode array will create multiple small thermal zones to destroy a long section of the nerve. This allows for greater accuracy and length of nerve destruction.
  • a linear electrode array is used from within a vein, artery, or vessel (e.g., the main azygos vein), which may travel in parallel with a target nerve (e.g., the splanchnic nerve), wherein the linear electrode array will be configured to create multiple small thermal zones to destroy a long section of the nerve. This allows for greater accuracy and length of nerve destruction.
  • the linear electrode array positioned within the target nerve will also be configured to stimulate the target nerve.
  • the electrode array is arranged so as to be spaced apart from each other, such that, each electrode is configured to target ablation at a corresponding location on the target nerve (e.g., after the needle-electrode has punctured through a vessel wall).
  • the needle-electrode is configured to target ablation of a length of a target nerve that corresponds to at least a length of an electrode array disposed on a needle-electrode.
  • the plurality of electrodes are placed on one side of the needle-electrode to differentially change the thermal map of the ablation zone, so that it is directed specifically at the target nerve.
  • each needle-electrode is in operative communication with a power supply (as described herein).
  • the same power supply is configured to deliver power to each needle electrode.
  • two or more power supplies are configured to deliver power to a plurality of needle electrodes.
  • the power supply is located external to the subject.
  • the power supply comprises a controller to modulate the power delivered to the electrodes on the needle assembly.
  • the power supply is in operative communication with a controller to modulate the power delivered to the electrodes.
  • the controller is located on and/or within the device body.
  • the controller comprises a computing device.
  • the power supplied to each needle-electrode of a needle assembly is sufficient to ablate a portion of the target nerve.
  • the power supplied to each needleelectrode emits radio radiofrequency energy (for example) that generates heat, which results in ablation of a portion of the target nerve.
  • the power supply and controller are configured to modulate the power delivered to the device so as to vary the amount of radiofrequency energy delivered by each needle-electrode.
  • a power supply is provided with the device itself (e.g., batteries located within or about the device body).
  • a user is able to modulate the power delivered to and by each needle-electrode via an externally modulated controller in operative communication with the device.
  • the device is configured to deliver a chemical to the target nerve so as to chemically ablate the target nerve. In some embodiments, the device is configured to deliver a controlled amount of a fluid to and/or about the target nerve, so as to interrupt nerve activity of the target nerve.
  • the fluid comprises a chemical. In some embodiments, the fluid comprises one or more fluids. In some embodiments, the one or more fluids are in gaseous and/or liquid form. In some embodiments, the fluid comprises carbon dioxide, ethanol, liquid nitrogen, a conductive substance (e.g., saline, specialized hydrogel, etc.), an alcohol, lidocaine, lidocaine analogues, or a combination thereof.
  • the needle assembly comprises one or more hollow needles (e.g., see FIG. 15).
  • each hollow needle comprises an opening disposed at any location on the hollow needle.
  • each hollow needle is configured to dispense a fluid (e.g., a chemical) via the opening.
  • each hollow needle is configured to promote chemical ablation of a portion of a target nerve by dispensing a fluid onto the target nerve and/or about the target nerve.
  • the fluid to be delivered is stored within the hollow needle prior to deployment of the hollow needle.
  • each hollow needle is in fluid communication with a fluid source.
  • each hollow needle is configured to dispense the fluid in a controlled manner so as to chemically ablate a prescribed or minimum portion of the target nerve.
  • the device is configured to reduce the temperature of and/or about the target nerve so as to create an ice ball in the target nerve as a function of cryotherapy ablation.
  • the needle assembly comprises hollow needles, as described herein, to form an ice ball to destroy a portion of the target nerve tissue.
  • the hollow needle are configured to dispense a cool fluid to the target nerve and/or about the target nerve, thereby enabling a portion of the target nerve to be destroyed.
  • the needle-assembly comprising hollow needles is configured to separate at a distal end, as described herein for the needle-electrodes, so as to target chemical ablation and/or cryoablation at specific locations of a target nerve, thereby enabling a longer length of ablation of the target nerve.
  • the device is configured to operate other types of ablation modalities (in addition to or alternative to radiofrequency ablation, microwave ablation, chemical ablation, and/or cryoablation), such as ultrasound ablation, and/or alcohol ablation.
  • ablation modalities in addition to or alternative to radiofrequency ablation, microwave ablation, chemical ablation, and/or cryoablation
  • ultrasound ablation and/or alcohol ablation.
  • the device is configured to stimulate the target nerve, and/or configured to sense activity by the target nerve.
  • the device comprises one or more neurostimulation electrodes for stimulating the target nerve.
  • the device comprises a neurosensory region configured for sensing the target nerve.
  • the one or more neurostimulation electrodes and the one or more neurosensory region is located on the device body of the device.
  • the neurosensory region, the one or more neurostimulation electrodes, and/or the one or more ablation electrodes are located at any location on a device body of the device (e.g., catheter).
  • the neurosensory region comprises a sensor for detecting action potentials from a target nerve. In some embodiments, the neurosensory region comprises one or more neurosensory electrodes for detecting action potentials from a target nerve. In some embodiments, the one or more neurosensory electrodes and the one or more neurostimulation electrodes comprise different electrodes. In some embodiments, the one or more neurosensory electrodes and the one or more neurostimulation electrodes share the same electrodes. In some embodiments, the one or more neurostimulation electrodes is configured to provide stimulation to the target nerve in a monopolar manner. In some embodiments, the one or more neurostimulation electrodes is configured to provide stimulation to the target nerve in a bipolar manner.
  • the device is configured to alternate between a neurosensory mode of operation (e.g., senses action potentials of the target nerve) and a neurostimulation mode of operation (e.g., provides a stimulation to the target nerve).
  • a neurosensory mode of operation e.g., senses action potentials of the target nerve
  • a neurostimulation mode of operation e.g., provides a stimulation to the target nerve.
  • the device is configured to operate in a neurosensory mode and a neurostimulation mode simultaneously.
  • the neurostimulation mode comprises one or more neurostimulation electrodes configured to stimulate the target nerve to elicit nerve activity (e.g., nerve action potential) and/or physiological changes (e.g., sympathetic nerve response).
  • nerve activity e.g., nerve action potential
  • physiological changes e.g., sympathetic nerve response
  • one or more physiological monitoring devices are provided to measure, sense, and/or detect nerve activity and/or physiological changes (e.g., a sympathetic response) based on stimulation of a target nerve (as described herein).
  • the one or more physiological monitoring devices comprises a Swan Ganz catheter for PCWP measurement.
  • the one or more physiological monitoring devices is configured to read and interpret the following physiological signals during a method described herein in real time or substantially real time: gastrointestinal changes, palmar sweating, PCWP, temperature for rectal and/or skin measurement, renal output in relation to changes in vascular dilation, metabolism changes, and/or serum brain natriuretic peptide levels.
  • a user e.g., a physician or other health care personnel
  • a user e.g., a physician or other health care personnel
  • a user may then re- position the device within the subject to again approximate the location of the target nerve, and provide stimulation again to detect for physiological changes.
  • the one or more physiological monitoring devices is in operative communication with a computing device and/or display to output the measured physiological readings and/or changes.
  • at least one physiological monitoring device is integrated with the catheter-based device described herein.
  • the device e.g., catheter-based device
  • the nerve is used to stimulate the nerve again (as described herein).
  • the destroyed portion of the target nerve results in a lack of physiological change when stimulated (e.g., via a neurostimulation component as described herein).
  • detecting decreased PCWP is an indication of GSN activity interruption, as this suggests blood being drawn away from the heart.
  • the one or more neurosensory electrodes are configured to detect action potentials from the target nerve. In some embodiments, the one or more neurosensory electrodes are configured to output the detection of action potentials to a user via an external device, computing device, or other mechanism known in the art.
  • the device described herein e.g. catheter-based device
  • the power supply e.g., a generator
  • the power supply is configured to modulate the power delivered to the device.
  • the power supply is configured to 1) provide neurostimulation energy to the neurostimulation electrodes, 2) provide ablation energy to the ablation electrodes, and/or 3) enable the device to detect, read, and/or interpret nerve signals via the neurosensory region (e.g., via a sensor or neurosensory electrodes).
  • the power supply comprise a controller, and/or is in communication with a controller, configured to modulate the power supplied to the device.
  • the controller comprises a computing device and/or a display to output information.
  • a separate power supply and/or controller is configured to provide power to each of the ablation electrodes, the neurostimulation electrodes, and/or the neurosensory region.
  • the power supply e.g., a generator
  • the power supply is configured to provide radiofrequency energy so as to create a thermal ablation zone in the nerve tissue.
  • said thermal ablation zone is subject to heat generated by the radiofrequency energy provided by, for example, one or more ablation electrodes.
  • providing radiofrequency energy comprises alternating current (for example, in the range of 350-500kHz).
  • the device is configured to destroy at least a portion of a target nerve and vein tissue (for example, via the generator and/or electrodes located on the device that have punctured the vein wall and contact the target nerve or are placed proximate to the target nerve).
  • the device is configured to provide radiofrequency energy to stimulate a target nerve or group of nerves without damaging the nervous tissue of the target nerve and/or surrounding tissue.
  • the device e.g., catheter-based device
  • power supply e.g., generator
  • the device is configured to modulate the voltage and current output according to a desired power of the ablation energy (e.g., radiofrequency energy, microwave energy) delivered (via the ablation electrodes) to the target nerve.
  • the power supply is in operative communication with a controller to modulate the voltage and current output.
  • the device comprises the controller located therein (e.g., within and/or on the device body).
  • the ablation energy is provided with sufficient voltage and current to generate sufficient heat (that is transferred to the target nerve) to destroy at least a portion of the target nerve.
  • the power supply is configured to provide power from about 1W to about 100W to the device. In some embodiments, at least a portion of the target nerve is destroyed to the full circumference of the target nerve (as described herein).
  • the device and/or power supply is further configured to modulate a power of ablation energy (e.g., radiofrequency energy, microwave energy) delivered so as to be able to destroy vein tissue and cause vessel sclerosis, such that a device described herein is further configured to reduce, prevent and/or stop bleeding. In some embodiments, such destruction of vein tissue and vessel sclerosis is via the ablation electrodes and/or another set of electrodes.
  • ablation energy e.g., radiofrequency energy, microwave energy
  • the power supply is configured to deliver a charge strong enough for neurostimulation, so as to elicit a nerve response (e.g., via the neurostimulation electrodes), but not strong enough to damage tissue (e.g., target nerve tissue and/or surrounding tissue).
  • a controller as described herein is configured to modulate the charge delivered by the neurostimulation electrodes.
  • the power supply receives power from an external wall unit.
  • the power supply e.g., generator
  • the power supply comprises one or more power sources located therein (e.g., batteries).
  • FIGS. 2-27B depict exemplary embodiments of a device (e.g., catheter-based device) described herein, and for use with a method described herein.
  • a device e.g., catheter-based device
  • any of such exemplary device embodiments comprise any combination of the features and components described above for a device described herein.
  • FIGS. 2-6 provide an exemplary depiction of a first embodiment of a device 200 described herein, wherein a needle assembly comprising two needle-electrodes is used to ablate a portion of a target nerve.
  • the device comprises a device body (e.g., catheter body) 210, a catheter tip 202, a needle assembly 206 configured to be disposed within the catheter body, an opening 208 for the needle assembly 206 to extend from, and an electrode region 207 (e.g., for neurostimulation).
  • the opening 208 is a lateral opening.
  • the device body 210 has a longitudinal axis (203).
  • the electrode region is also the same location as a neurosensory region (e.g., for measuring action potentials), as described herein, which can be located anywhere on the catheter body 210.
  • the electrode region 207 is provided on the catheter body 210.
  • the device comprises a radiopaque area 204, which may be used to help track the location of the device within a subject.
  • the radiopaque area is located anywhere on the catheter body.
  • radiopacity helps enable rotational accuracy for positioning the needle assembly (as described herein).
  • the radiopaque mark appears different on the catheter body at 90 degree increments, thereby helping direct the needle assembly in the superior/inferior, anterior/posterior, lateral/medial, and/or cranial/caudal directions.
  • the device body 210 comprises a needle lumen, which extends within the device body and terminates at the lateral opening 208.
  • the needle assembly is located within the needle lumen.
  • the needle assembly comprises two needle-electrodes each comprising a separate needle stem 214, 215.
  • each needle-electrode comprises a corresponding electrode 212, 213 at a distal end of the needle assembly.
  • the electrodes are configured to be located any location on each needle-electrode.
  • each electrode 212, 213 is an ablation electrode configured to) provide radiofrequency energy or microwave energy to ablate at least a portion of a target nerve.
  • the electrodes 212, 213 are configured to act as a neurostimulation electrode and/or a neurosensory electrode.
  • the needle assembly 206 is placed within the catheter body in a compressed configuration, such that the needle stems 214, 215 and, in some instances, electrodes 212, 213, are pressed together.
  • the needle assembly 206 is configured to bifurcate upon exiting the opening 208, wherein the electrodes 212, 213 and at least a portion of the needle stems 214, 215 of the corresponding needle-electrodes are configured to separate from each other once extending out of the opening 208 (e.g., separate in a “V” shape).
  • the needle assembly comprises shape memory so as to be configured to bifurcate once exiting the opening 208 into an open space.
  • the needle assembly 206 is configured to bifurcate based on an actuated mechanism.
  • the actuated mechanism comprises an automated and/or manual actuation (e.g., actuation by a user).
  • the needle assembly 206 will bifurcate along or approximate a length of a target nerve, thereby enabling each electrode 212, 213 to contact or be placed proximate to two different locations on the target nerve.
  • a needle assembly push stem (or other structure) is provided within the catheter body 210 and configured to engage with the needle assembly so as to push the needle assembly 206 through the opening 208.
  • the push stem is located within the catheter body 210 and configured to be actuated so as to automatically push the needle assembly 206 out of the opening 208.
  • automatic actuation of the push stem is initiated by a wireless or wired signal provided by the user.
  • the push stem is configured to be manually pushed out by a user (via a mechanism that extends from the device to outside the subject).
  • the needle assembly e.g., electrodes 212, 213, are configured to extend a prescribed distance out of the opening so as to puncture through a vein wall and contact or be located proximate to a target nerve (e.g. GSN, as described herein).
  • a target nerve e.g. GSN, as described herein.
  • the needle assembly 206 is provided within a needle assembly tube (not shown) located within the catheter body 210.
  • the tube is configured to extend from the opening 208 to the vein wall, wherein the needle assembly is then configured to be extend from an end of the tube and puncture through the vein wall.
  • the needle assembly tube is similar to the tube depicted in FIGS. 7-11 with reference character 309.
  • the catheter body 210 is configured to rotate so as to orient the needle assembly in a prescribed direction relative to the target nerve.
  • the needle assembly is configured to extend from the catheter body according to a specific configuration, which corresponds to the location of a radiopacity marker (e.g., 204), such that the direction and position of the electrodes on the needle assembly when extended can be correlated with the location of the radiopacity marker.
  • a radiopacity marker e.g., 204
  • FIGS. 5-6 depict an exemplary depiction of the device 200 located within a vein, artery, or vessel 218 (e.g., left and/or right intercostal vein branch 2204 from FIG. 22), wherein the needle assembly 206 is extending from the opening 208 and contacting a target nerve (e.g., GSN) in a bifurcated configuration at two different locations located between two portions of the target nerve 220, 221 (see FIG. 6). As described herein, in some embodiments, the needle assembly 206 will bifurcate along a length of a target nerve.
  • a target nerve e.g., GSN
  • the catheter body 210 is configured to be rotatable, so as to position the bifurcated needle stems 214, 215 along a length of a target nerve.
  • the needle assembly extends in a non-zero angle relative to the longitudinal axis 203.
  • the needle stems 214, 215 are bifurcated along a z-axis, corresponding to a length of the target nerve between the two locations 220, 221.
  • the electrodes 212, 213 are configured to ablate (e.g., circumferentially lyse) a length of the target nerve that is at least the length from target nerve location 220 to target nerve location 221.
  • the target nerve circumference 220, 221 represents the ablation area (at a given location), wherein the portion of the target nerve between portions 220, 221 represents the length of the ablation area.
  • the longer the length of the ablation area provides for a longer treatment period for a medical condition described herein (e.g., heart failure).
  • the electrode region area 207 is configured to provide a stimulation to the target nerve (via for example, neurostimulation electrodes described herein).
  • the electrode region is positioned within the subject (for e.g., via radi opacity markers and/or a neurosensory region) at a location that corresponds to the target nerve (e.g., location may be such that where neurostimulation is provided to the target nerve in a perpendicular direction to an axis of the catheter body 210).
  • stimulation is provided via signals delivered perpendicularly.
  • the configuration of the needle assembly extending from the catheter body correlates with a positioning of the electrode region 207.
  • the device comprises a device body (e.g., catheter body) 310, a catheter tip 302, a needle assembly 306 configured to be disposed with a balloon 308 located about the catheter body 310, and an electrode region 307 (e.g., for neurostimulation).
  • the device body 310 has a longitudinal axis (303).
  • the electrode region is also the same location as a neuro sensory region, as described herein, which can be located anywhere on the catheter body 310.
  • the electrode region 307 is disposed on the balloon 308.
  • the device 300 further comprises a needle assembly tube 309, within which at least a portion of the needle assembly 306 is configured to be located and further configured to extend from.
  • the needle assembly tube 309 is embedded with the balloon 308 and protrudes therefrom.
  • the device 300 does not comprise a needle assembly tube, and instead the needle assembly 306 is located on the balloon 308, at least partially located within the balloon, or a combination thereof.
  • the needle assembly tube is at least partially located within the device body 310.
  • the device comprises a radiopaque area 304, which may be used to help track the location of the device within a subject.
  • the radiopaque area is located anywhere on the catheter body.
  • radi opacity helps enable rotational accuracy for positioning the needle assembly (as described herein).
  • the radiopaque mark appears different on the catheter body at 90 degree increments, thereby helping direct the needle assembly in the superior/inferior anterior/posterior, lateral/medial, and/or cranial/caudal directions.
  • the needle assembly 306 comprises two separate needle-electrodes, each comprising a needle stem 314, 315.
  • each needleelectrode comprises a corresponding electrode 312, 313 at a distal end of the needle assembly.
  • the electrodes are configured to be located any location on each needleelectrode.
  • each electrode 312, 313 is an ablation electrode configured to) provide radiofrequency energy to ablate at least a portion of a target nerve.
  • the electrodes 312, 313 are configured to act as a neurostimulation electrode and/or a neurosensory electrode.
  • at least a portion of the needle assembly 306 is located within the needle assembly lumen 309 when the device is being advanced to a desired location within the subject.
  • the needle assembly 306 is configured to extend from the needle assembly tube 309.
  • the needle assembly 306 is configured to be provided in a compressed configuration, such that the needle stems 314, 315 and, in some instances, electrodes 312, 313, are pressed together.
  • the needle assembly 306 is configured to bifurcate upon extending from the needle assembly lumen 309, wherein the electrodes 312, 313 and at least a portion of the needle stems 314, 315 of the needleelectrodes are configured to separate from each other (e.g., the needle assembly comprises a “V- shaped” configuration).
  • the needle assembly 306 comprises shape memory so as to be configured bifurcate once extending a predetermined length from the needle assembly tube 309.
  • the needle assembly 306 is configured to bifurcate based on an actuated mechanism.
  • the actuated mechanism comprises an automated and/or manual actuation (e.g., actuation by a user).
  • the actuated mechanism comprises an automated and/or manual actuation.
  • the needle assembly 306 will bifurcate along a length of a target nerve, thereby enabling each electrode 312, 313 to contact or be placed proximate to two different locations on the target nerve.
  • FIGS. 10-11 depict an exemplary depiction of the device 300 located within a vein, artery, or vessel 316 (e.g., left and/or right intercostal vein branch 2204 from FIG. 22) and proximate to the location of a target nerve 318.
  • FIG. 10 depicts the balloon 308 in a deflated configuration and prior to deployment of the needle assembly 306, while FIG. 11 depicts the balloon 308 in an inflated configuration.
  • the needle assembly 306 is positioned, such that, inflating the balloon 308 pushes out the needle assembly tube 309, thereby enabling the needle assembly 306 to puncture through the vein 316 wall (see FIG. 11).
  • inflating the balloon 308 biases needle assembly tube 309 against the vessel wall, such that the needle assembly 306 is configured to puncture through the vessel wall when extending from the needle assembly tube. In some embodiments, inflating the balloon 308 biases needle assembly tube 309 against the vessel wall, but wherein the needle assembly 306 does not yet puncture the vessel wall unless extending from the needle assembly tube. In an alternate embodiment, the needle assembly is configured to bias against the vessel wall through a means other than an inflatable balloon (as known in the art).
  • the balloon 308 is in fluid communication with an inflation medium that enables the balloon to be inflated.
  • the device body 310 comprises an inflation tube that extends therein, and that is fluid communication with an inflation medium source.
  • inflation medium comprises a fluid, such as a gas (e.g., air, etc.), and/or a liquid (e.g., water, saline, etc.).
  • the inflation medium source is located outside the subject.
  • the device comprises a stored supply of the inflation medium for inflating the balloon 308.
  • the inflation medium is supplied via an automatic controller.
  • the inflation medium is supplied via manual input.
  • FIGS. 12-13 depict an exemplary embodiment of the needle assembly 306 extending towards the target nerve 318.
  • inflation of the balloon enables the needle assembly 306 to extend towards the target nerve.
  • a needle assembly push stem (or other structure) is provided within the catheter body 310 and configured to engage and push the needle assembly 306 through the vessel wall and/or towards the target nerve.
  • the push stem is located within the catheter body 310 and configured to be actuated so as to automatically push the needle assembly 306.
  • automatic actuation of the push stem is initiated by a wireless or wired signal provided by the user.
  • the push stem is configured to be manually pushed out by a user (via a mechanism that extends from the device to outside the subject).
  • the needle assembly 306, e.g., the electrodes 312, 313, are configured to extend a prescribed distance from the needle assembly lumen 309, so as to contact or be located proximate to a target nerve 318 (e.g. GSN, as described herein).
  • the catheter body 310 is configured to rotate so as to orient the needle assembly 306 in a prescribed direction relative to the target nerve.
  • the needle assembly is configured to extend from the catheter body according to a specific configuration, which corresponds to the location of a radiopacity marker (e.g., 304), such that the direction and position of the electrodes on the needle assembly when extended can be correlated with the location of the radiopacity marker.
  • a radiopacity marker e.g., 304
  • FIG. 13 depicts an exemplary depiction of the needle assembly 306 extending and contacting a target nerve (e.g., GSN) in a bifurcated configuration at two different locations located between two portions of the target nerve 318, 319.
  • a target nerve e.g., GSN
  • the needle assembly 306 will bifurcate along a length of a target nerve.
  • the needle assembly 306 extends in a non-zero angle relative to the longitudinal axis 303.
  • the needle assembly 306 is configured to be rotatable about a needle assembly axis, so as to position the bifurcated needle stems 314, 315 of the needle-electrodes along a length of a target nerve.
  • the catheter body 310 is characterized as being positioned along an x-axis
  • the needle stems 314, 315 are bifurcated along a z-axis, corresponding to a length of the target nerve between the two locations 318, 319.
  • the electrodes 312, 313 are configured to ablate (e.g., circumferentially lyse) a length of the target nerve that is at least the length from target nerve location 318 to target nerve location 319.
  • the target nerve circumference 318, 319 represents the ablation area, at a given location, wherein the portion of the target nerve between portions 318, 319 represents the length of the ablation area.
  • the longer the length of the ablation area provides for a longer treatment period for a medical condition described herein (e.g., heart failure).
  • the electrode region area 307 is configured to provide a stimulation to the target nerve (via for example, neurostimulation electrodes described herein).
  • the electrode region is positioned within the subject (for e.g., using radiopacity markers and/or a neurosensory region) at a location that corresponds to the target nerve (e.g., location may be such that where neurostimulation is provided to the target nerve in a perpendicular direction an axis of the catheter body 310).
  • stimulation is provided via signals delivered perpendicularly.
  • the configuration of the needle assembly extending from the catheter body correlates with a positioning of the electrode region 307.
  • FIGS. 14-17 provide an exemplary depiction of a third embodiment of a device 400 described herein, wherein the device is configured to chemically ablate a target nerve.
  • the device comprises a device body (catheter body) 410, a catheter tip 402, a needle assembly 406 configured to be disposed with an expandable balloon 408 located about the catheter body 410, and an electrode region 407 (e.g., for neurostimulation).
  • the device body 410 has a longitudinal axis (403).
  • the electrode region is also the same location as a neuro sensory region, as described herein, which can be located anywhere on the catheter body 410.
  • the electrode region 407 is disposed on the expandable balloon 408.
  • the device 400 further comprises a needle assembly tube 409, within which at least a portion of the needle assembly 406 is configured to be located and further configured to extend from.
  • the needle assembly tube 409 is embedded with the expandable balloon 408 and protrudes therefrom.
  • the device comprises a radiopaque area 404, which may be used to help track the location of the device within a subject.
  • the radiopaque area is located anywhere on the catheter body.
  • radi opacity helps enable rotational accuracy for positioning the needle assembly (as described herein).
  • the radiopaque mark appears different on the catheter body at 90 degree increments, thereby helping direct the needle assembly in the superior/inferior, anterior/posterior, lateral/medial, and/or cranial/caudal directions.
  • the needle assembly 406 of the device 400 comprises a needle stem 414 and a needle port 412.
  • the needle stem is hollow.
  • the device is configured to dispense a chemical through the needle port 412.
  • the chemical is configured to ablate the target nerve.
  • the device is configured to dispense the chemical with a controlled distribution so as to achieve a desired ablation length of the target nerve.
  • at least a portion of the needle assembly 406 is located within the needle assembly lumen 409 when the device is being advanced to a desired location within the subject.
  • the needle assembly 406 is configured to extend from the needle assembly lumen 409.
  • FIGS. 16-17 depict an exemplary depiction of the device 400 located within a vein, artery, or vessel 416 (e.g., left and/or right intercostal vein branch 2204 from FIG. 22) and proximate to the location of a target nerve 418.
  • FIG. 16 provides an exemplary depiction of the expandable balloon 408 in an expanded configuration, wherein the needle assembly tube 409 is biased towards the vein wall 416, such that the needle assembly 406 punctures through the vein wall 416.
  • expanding the expandable balloon 408 biases needle assembly tube 409 against the vessel wall, such that the needle assembly 406 is configured to puncture through the vessel wall when extending from the needle assembly tube.
  • the expandable balloon 408 is in operative communication with a mechanism configured to supply a gas (e.g., air) to the expandable balloon, thereby causing it to expand.
  • a gas e.g., air
  • the gas is supplied via a supply line connecting a gas source (e.g., outside the subject) to the device.
  • the device comprises a stored supply of the gas for expanding the expandable balloon 408.
  • the gas is supplied via an automatic controller.
  • the gas is supplied via manual input.
  • FIGS. 17 depicts an exemplary embodiment of the needle assembly 406 extending towards the target nerve 418.
  • expansion of the balloon 408 enables the needle assembly 406 to extend towards the target nerve.
  • a needle assembly push stem (or other structure) is provided within the catheter body 410 and configured to engage and push the needle assembly 406 towards the target nerve.
  • the push stem is located within the catheter body 410 and configured to be actuated so as to automatically push the needle assembly 406.
  • automatic actuation of the push stem is initiated by a wireless or wired signal provided by the user.
  • the push stem is configured to be manually pushed out by a user (via a mechanism that extends from the device to outside the subject).
  • the needle assembly 406, e.g., needle port 412 is configured to extend a prescribed distance from the needle assembly lumen 409, so as to contact or be located proximate to a target nerve 418 (e.g. GSN, as described herein).
  • the needle assembly is configured to extend in a non-zero angle relative to the longitudinal axis 403.
  • the needle assembly 406 is configured to rotate about a needle assembly axis.
  • the needle assembly is configured to be rotated by the push stem.
  • the needle assembly 406 is configured to be rotationally guided until the needle is positioned in the direction of the target nerve (e.g., GSN).
  • the needle assembly 406 extends toward the target nerve at a location between two portions of the target nerve 418, 419.
  • the catheter body 410 is configured to be rotatable so as to orient the needle assembly 406, including the needle port 412, in prescribed direction (relative to the target nerve.
  • the needle port 412 penetrates the target nerve so as to deliver the chemical ablation therein.
  • the needle port 412 delivers the chemical ablation on and about an exterior surface of the target nerve.
  • the chemical delivery enables ablation (e.g., circumferentially lyse) of the target nerve along the length from target nerve location 418 to target nerve location 419.
  • the target nerve circumference 418, 419 represents the ablation area, at a given location, wherein the portion of the target nerve between portions 418, 419 represents the length of the ablation area.
  • the longer the length of the ablation area provides for a longer treatment period for a medical condition described herein (e.g., heart failure).
  • the hollow needle stem 414 is in operative communication with a mechanism configured to supply the chemical to the needle assembly.
  • the chemical is supplied via a supply line connecting a chemical source (e.g., outside the subject) to the device.
  • the device comprises a stored supply of the chemical for delivery to or about the target nerve.
  • the chemical is supplied via an automatic controller.
  • the chemical is supplied via manual input.
  • the chemical comprises carbon dioxide, ethanol, liquid nitrogen, a conductive substance (e.g., saline, specialized hydrogel, etc.), or a combination thereof.
  • the electrode region area 407 is configured to provide a stimulation to the target nerve (via for example, neurostimulation electrodes described herein).
  • the electrode region is positioned within the subject (for e.g., using radiopacity markers and/or a neurosensory region) at a location that corresponds to the target nerve (e.g., location may be perpendicular to an axis of the catheter body 410). Accordingly, in some embodiments, stimulation is provided via signals delivered perpendicularly.
  • the configuration of the needle assembly extending from the catheter body correlates with a positioning of the electrode region 407.
  • FIG. 18-21 depict an exemplary process for treating medical condition as described herein, wherein the process is categorized under 4 components of the exemplary process: Diagnosis, General Procedure, Site-Recognition / Confirmation, and Ablation.
  • FIG. 19 depicts exemplary steps for the General Procedure category, which include patient prep steps, such introduce a device (e.g., catheter device) within a subject and advancing the device to a predetermined location.
  • a device e.g., catheter device
  • FIG. 20 depicts exemplary steps for the Site-Recognition/Confirmation category, which includes confirming the location of a target nerve via nerve stimulation and corresponding nerve activity and/or physiological changes (e.g., sympathetic response) detected.
  • FIG. 21 depicts exemplary steps for the Ablation category, including various ablation modalities, such as ablation from within a vein, artery, or vessel (e.g., ultrasound, linear electrode array), through the vein wall (e g , see FIGS. 6, 13, and 17), and within the vein wall.
  • ablation modalities such as ablation from within a vein, artery, or vessel (e.g., ultrasound, linear electrode array), through the vein wall (e g , see FIGS. 6, 13, and 17), and within the vein wall.
  • FIGS. 23A-27B depict an exemplary depiction of the device 2300 described herein, wherein a telescopic needle assembly comprising an extendable needle and an electrode assembly, with a first section surrounding a second section, wherein the second section extends outwards from the first section, and which is used to ablate a target nerve.
  • a telescopic needle assembly comprising an extendable needle and an electrode assembly, with a first section surrounding a second section, wherein the second section extends outwards from the first section, and which is used to ablate a target nerve.
  • the device comprises a catheter shaft 2311, a handle 2306, a contrast port 2301, a guidewire port 2302, a catheter rotation knob 2303, an electrode advancer 2304, a rotary electrical connector 2305, a catheter tip 2316, an ablation needle exit port 2312, an ablation needle lumen 2314, a guidewire lumen 2318, a maker band 2317, a second marker band 2315, and a needle assembly 2313 comprising one or more electrodes (e.g., for neurostimulation or nerve ablation).
  • FIG. 23B illustrates the needly assembly fully extended 2319 from the device.
  • the catheter, ablation needle, guidewire port 2302, contrast port 2301, and rear connector 2305 spin in unison.
  • a guidewire is inserted into the guidewire port 2302 and is used to drives the catheter within a vascular lumen.
  • the contrast port 2302 is used for insertion of fluoroscopic contrast.
  • the rear connector includes pins for two ablation poles and three nerve stimulation and nerve monitoring leads.
  • the key way within the handle 2306 couples the rotation of the control knob and control catheter with the rear electrical connector and routes electrical connections to allow for continuous rotation.
  • the electrode advancer provides sufficient travel for the distal end of the ablation needle (e.g., needle assembly) to extend about 1-2 cm, in some cases 1.5 cm, from the catheter midline. In some embodiments, the needle assembly comprising one or more electrodes is not extended.
  • the needle assembly comprising one or more electrodes is extended.
  • the electrode advancer 2304 is used to extend the electrode assembly into vascular tissues, e.g., puncture a vascular tissue.
  • the guidewire is inserted into the guidewire lumen to advance the catheter tip 2316 into an intravascular space.
  • the electrode advancer advances a first tubular body of the needle assembly comprising a first proximal electrode and then a second tubular body extends from the first tubular body, and the extension length of the telescopic electrode assembly can be controlled by the user.
  • the guidewire is advances separately from the needle assembly comprising the one or more electrodes.
  • the rear electrical connector has three pins for nerve sensing and two bi-polar ablation poles.
  • the catheter length is from about 25-150 cm, in some cases 120 cm.
  • the nerve sensing elements one or more electrodes on a catheter shaft substrate that is wrapped around the catheter shaft 2311 and bonded in place.
  • the one or more electrodes on the needle assembly are the nerve sensing elements.
  • the one or more electrodes on a catheter shaft, or the one or more electrodes on the needle assembly is used to confirm placement of the needle prior to ablation via low power stimulation to observe the patient’s heart rate.
  • the device comprises a radiopaque area 404, which may be used to help track the location of the device within a subject.
  • the radiopaque area is located anywhere on the catheter body.
  • radi opacity helps enable rotational accuracy for positioning the needle assembly (as described herein).
  • the radiopaque mark appears different on the catheter body at 90 degree increments, thereby helping direct the needle assembly in the superior/inferior, anterior/posterior, lateral/medial, and/or cranial/caudal directions.
  • an electrical charge is delivered from a first electrode, which can be positive, to a second electrode, which can be negative, thereby sending energy to nearby vascular tissue and heating it to approximately 40 C, 50 C, or 60 C.
  • the catheter tip 2400 of the device 2420 comprises a guidewire lumen 2401, a marker band 2402/2403, an ablation needle exit port 2404, and a needle assembly 2313 comprising one or more electrodes, for example, a silk-screened electrode.
  • device 2420 comprises a contrast port 2301, a guidewire port 2302, a catheter rotation knob 2303, an electrode advancer 2304, a rotary electrical connector 2305, a rotation coupler 2421, and a rotation coupler 2422.
  • device 2420 is device 2300.
  • the device 2420 does not comprise the contrast port 2301.
  • a depiction of an exemplary second catheter tip 2800 is shown.
  • the second catheter tip 2800 comprises a guidewire lumen 2820, and an ablation needle lumen 2810 comprising an ablation needle exit port 2811.
  • a ratio between a radius of curvature of the ablation needle lumen 2810 proximal to the ablation needle exit port 2811 and a diameter of the ablation needle lumen 2810 is about 1 : 1 to about 3: 1.
  • a ratio between a radius of curvature of the ablation needle lumen 2810 proximal to the ablation needle exit port 2811 and a diameter of the ablation needle lumen 2810 is at least about 1 : 1. In some embodiments, a ratio between a radius of curvature of the ablation needle lumen 2810 proximal to the ablation needle exit port 2811 and a diameter of the ablation needle lumen 2810 is at most about 4: 1. In some embodiments, a ratio between a radius of curvature of the ablation needle lumen 2810 proximal to the ablation needle exit port 2811 and a diameter of the ablation needle lumen 2810 ranges from 1 : 1 to 4: 1.
  • a ratio between a radius of curvature of the ablation needle lumen 2810 proximal to the ablation needle exit port 2811 and a diameter of the ablation needle lumen 2810 is 1 : 1, 2: 1, 3: 1, or 4: 1. In some embodiments, a ratio between a radius of curvature of the ablation needle lumen 2810 proximal to the ablation needle exit port 2811 and a diameter of the ablation needle lumen 2810 is about 1.8. In some embodiments, this ratio reduces mechanical stress and the resulting force needed to deploy the needle, while enabling the use of larger needle. In some embodiments, the radius of curvature of the needle assembly passage is 0.09”.
  • the increased radius of curvature of the needle assembly passage permits for a smoother insertion and retraction of the telescopic needle assembly. In some embodiments, the increased radius of curvature of the needle assembly passage permits for a point of contact of the telescopic needle assembly with the target tissue at a substantially orthogonal angle. In some embodiments, the increased radius of curvature of the needle assembly lumen and angle of curvature of the needle assembly lumen bias the vascular catheter against the single direction of extension of the telescopic needle assembly, within the vein, and prevent movement of the vascular catheter within the vein when extending the telescopic needle assembly, providing for correct insertion of the needle as to target an area in proximity to the target nerve.
  • the inner diameter of the needle assembly passage is at least 0.033”. In some embodiments, the inner diameter of the needle assembly passage is 0.033”. In some embodiments, guidewire lumen is linear and does not curve around the needle assembly passage and is coextensive with at least a portion of the needle assembly passage. In some embodiments, a linear guidewire lumen coextensive with a portion of the needle assembly lumen is more easily positioned and guided into place as a result of the linear guidewire lumen which does not require the guidewire to bend within the shaft as force is provided to the catheter device and it is advanced through a vein.
  • the needle assembly comprises an enamel coated wire 2501, a proximal laser cut hypotube 2502 which may be a tubular body, a proximal laser cut hypotube polyimide insulator 2503, a first electrode band 2504, a second electrode band 2510, a laser cut hypotube dielectric washer 2506, an inner polyimide linear 2505, a distal polyimide cover 2509, a distal laser cut hypotube 2508 which may be a tubular body, and a solder paste or laser weld 2507.
  • the needle assembly may terminate in a point configured to puncture vascular tissue.
  • the enamel coated wire 2501 conducts electricity to one or more electrodes positioned on an outer surface of the needle assembly, for example, on an outer surface of the proximal laser cut hypotube 2502 (e.g., a tubular body), or on an outer surface of a distal laser cut hypotube 2508 (e.g., a tubular body).
  • the laser cut hypotube dielectric washer 2506 and inner polyimide linear 2505 are insulating.
  • one or more electrodes 2504/2510 are electrical poles on the ablation needle assembly 2500 and may be marker bands. In some embodiments, with reference to FIG.
  • the needle assembly comprises a longitudinal axis2512, a distal laser cut hypotube 2508 (e.g., tubular body), a first electrode 2504, a second electrode 2510, and a proximal laser cut hypotube 2502 (e.g., tubular body).
  • a distal laser cut hypotube 2508 e.g., tubular body
  • a first electrode 2504 e.g., tubular body
  • a second electrode 2510 e.g., tubular body
  • a proximal laser cut hypotube 2502 e.g., tubular body
  • the telescopic needle assembly may comprise a first section surrounding a second section, wherein the second section extends outwards from the first section.
  • the first section comprises a first tubular body
  • the second section comprises a second tubular body, wherein the first tubular body extends outward from the second tubular body, and wherein the first tubular body nests within the second tubular body such that the tubular body is fully or partially contained within the first tubular body.
  • the needle assembly comprises a multi-strain braid 2601 which may be conductive, a proximal laser cut hypotube 2502 (e.g., a tubular body), a proximal laser cut hypotube polyimide insulator 2503, a first electrode 2504, a second electrode 2510, a laser cut hypotube dielectric washer 2506, an inner polyimide linear 2505, a distal polyimide cover 2509, a distal laser cut hypotube 2508 (e.g., a tubular body), and a solder paste or laser weld 2507.
  • the needle assembly may terminate in a point configured to puncture vascular tissue.
  • the multi-strain braid 2601 conducts electricity to one or more electrodes 2504/2510 positioned on an outer surface of the needle assembly, for example, on an outer surface of the proximal laser cut hypotube 2502 (e.g., a tubular body), or on an outer surface of a distal laser cut hypotube 2508 (e.g., a tubular body).
  • the laser cut hypotube dielectric washer 2506 and inner polyimide linear 2505 are insulating.
  • one or more electrodes 2504/2510 are electrical poles on the ablation needle assembly 2600 and may be marker bands. In some embodiments, with reference to FIG.
  • the needle assembly comprises a longitudinal axis 2512, a distal laser cut hypotube 2508, a marker band 2504, a marker band 2510, and a proximal laser cut hypotube 2502.
  • the needle assembly further comprises a third section comprising a sharp distal point, wherein the second section surrounds the third section, wherein the third section extends outward from the second section.
  • the telescopic needle assembly comprises a first section surrounding a second section, wherein the second section extends outwards from the first section.
  • the first section comprises a first tubular body
  • the second section comprises a second tubular body, wherein the first tubular body extends outward from the second tubular body, and wherein the first tubular body nests within the second tubular body such that the tubular body is fully or partially contained within the first tubular body.
  • the needle assembly further comprises a third section comprising a sharp distal point, wherein the second section surrounds the third section, wherein the third section extends outward from the second section.
  • the electrode assembly comprises an enamel coated wire 2701/2702, a rear keyway 2703, a front keyway 2704, a rotary hub 2705, a proximal support tube 2706 (e.g., tubular body), a distal laser cut hypotube 2707 (e.g., tubular body), and a distal laser cut hypotube tip 2708 (e.g., tubular body, which may terminate in a point).
  • the distal laser cut hypotube 2707 (e.g., tubular body) is bonded to the support tube 2706 with conductive epoxy.
  • the proximal enamel-coated wire 2702 is tinned and placed between the proximal support tube 2706 and rotary hub 2705 before they are also bonded using conductive epoxy.
  • distal laser cut hypotube 2707 (e.g., tubular body) extends until a first length, at which point second portion distal laser cut hypotube tip 2708 (e.g., tubular body) will extend.
  • the cross-sectional view has a vertical axis 2710.
  • the cross-sectional view includes needle lumen 2314, enamel coated wire 2701, a proximal support tube 2706, a distal laser cut hypotube 2707, and an inner polyimide linear 2505. Illustrated in FIG. 27B is the telescopic nesting of some embodiments of the needle assembly.
  • a needle lumen which encloses within it a proximal support tube 2706 (e.g., tubular body), which encloses within it a distal laser cut hypotube 2707 (e.g., tubular body), which encloses within it a proximal support tube 2706 (e.g., tubular body), which encloses within it a conductive wire, e.g., an enamel coated 2701.
  • the distal laser cut hypotube 2707 e.g., tubular body
  • the distal laser cut hypotube 2707 may extend outward from the proximal support tube 2706 such that the needle assembly may be fully extended.
  • the needle may nest within itself in a telescopic configuration with the distal laser cut hypotube 2707 (e.g., tubular body) extending from within the proximal support tube 2706 (e.g., tubular body), with the proximal support tube 2706 (e.g., tubular body) extending outwards from the catheter.
  • the telescopic needle assembly 2900 may comprise a jacket coated wire 2901, a distal laser cut hypotube 2902, a proximal laser cut hypotube 2903, a first jacket 2904, a second jacket 2905, a pole separator 2906, a marker ban 2908 positioned within the laser cut hypotube, and an end cap 2907.
  • the first jacket may be omitted.
  • increased diameter of the distal laser cut hypotube 2902 and the proximal laser cut hypotube 2903 provides an increased outer electrode surface area to distribute the applied current over a larger area of tissue, thus providing for application of increased energy while reducing the risk/chance of burning or charring tissue receiving the electrical current, which would then adhere to the electrode surfaces, and pull out with the needle assembly upon retraction.
  • a ratio between a diameter and a surface area-per-inch of the distal laser cut hypotube 2902, the proximal laser cut hypotube 2903, or both is about 0.05 to about 0.4.
  • a ratio between a diameter and a surface area-per-inch of the distal laser cut hypotube 2902, the proximal laser cut hypotube 2903, or both is about 0.32. In some embodiments, a ratio between a diameter and a surface area-per-inch of the distal laser cut hypotube 2902, the proximal laser cut hypotube 2903, or both is about 0.05, 0.1, 0.2, 0.3, or 0.4, including increments therebetween. In some embodiments, a ratio between a diameter and a surface area-per-inch of the telescopic needle assembly and the one or more electrodes is at least 0.05.
  • a ratio between a diameter and a surface area-per-inch of the telescopic needle assembly and the one or more electrodes is about 0.05 to about 0.15. In some embodiments, a ratio between a diameter and a surface area-per-inch of the telescopic needle assembly and the one or more electrodes is up to 0.15.
  • the distal laser cut hypotube 2902 and the proximal laser cut hypotube 2903 are flexible while providing both a column strength to penetrate tissue and tensile strength to keep the ablation needle poles from expanding/stretching during retraction into the catheter.
  • the marker ban 2907 enables visualization of the telescopic needle assembly 2900 during use, while preventing snagging upon the tissue due to its placement within the hypotube as to reduce transitions about the exterior surface of the hypotube and maintain a smooth surface about the exterior surface of the hypotube.
  • a pole separator 2906, the first jacket 2904, the second jacket 2905, or any combination thereof are made of a non-ferrous electrically insulating material.
  • each of the one or more electrodes has a surface area of at least about 0.01 in 2 , 0.0125 in 2 , 0.015 in 2 , 0.0175 in 2 , or more, including increments therein. In some embodiments, the one or more electrodes has a surface area of about 0.02 square inches to about 0.03 square inches.
  • the one or more electrodes has a surface area of about 0.02 square inches to about 0.021 square inches, about 0.02 square inches to about 0.022 square inches, about 0.02 square inches to about 0.023 square inches, about 0.02 square inches to about 0.025 square inches, about 0.02 square inches to about 0.0255 square inches, about 0.02 square inches to about 0.026 square inches, about 0.02 square inches to about 0.0275 square inches, about 0.02 square inches to about 0.028 square inches, about 0.02 square inches to about 0.029 square inches, about 0.02 square inches to about 0.03 square inches, about 0.021 square inches to about 0.022 square inches, about 0.021 square inches to about 0.023 square inches, about 0.021 square inches to about 0.025 square inches, about 0.021 square inches to about 0.0255 square inches, about 0.021 square inches to about 0.026 square inches, about 0.021 square inches to about 0.0275 square inches, about 0.021 square inches to about 0.028 square inches, about 0.021 square inches to about 0.029
  • the one or more electrodes has a surface area of about 0.02 square inches, about 0.021 square inches, about 0.022 square inches, about 0.023 square inches, about 0.025 square inches, about 0.0255 square inches, about 0.026 square inches, about 0.0275 square inches, about 0.028 square inches, about 0.029 square inches, or about 0.03 square inches. In some embodiments, the one or more electrodes has a surface area of at least about 0.02 square inches, about 0.021 square inches, about 0.022 square inches, about 0.023 square inches, about 0.025 square inches, about 0.0255 square inches, about 0.026 square inches, about 0.0275 square inches, about 0.028 square inches, or about 0.029 square inches.
  • the one or more electrodes has a surface area of at most about 0.021 square inches, about 0.022 square inches, about 0.023 square inches, about 0.025 square inches, about 0.0255 square inches, about 0.026 square inches, about 0.0275 square inches, about 0.028 square inches, about 0.029 square inches, or about 0.03 square inches.
  • the telescopic configuration of the needle assembly may be advantageous over alternative configurations in that it may minimize sharp force trauma to vascular tissue which it is penetrating, and other tissue surrounding the target nerve, when it is extended, as it may primarily extend in a straight (or relatively straight) vector which will not displace tissue adjacent to the telescopic needle assembly.
  • the telescopic and may be more likely to properly extend and retract without trapping vascular tissue within the needle assembly or in between components of the needle assembly as compared to a bifurcating configuration.
  • the length of extension of the telescopic needle assembly comprising the electrode assembly can be controlled by an operator, and the length between the electrodes on the telescopic needle assembly can be varied, permitting for increased ablation length for configurations with a larger displacement between the electrodes, or reduced ablation length for configurations with a smaller displacement between the electrodes.
  • the ease of extension of the telescopic needle assembly may improve the operator’s ability to achieve or maintain a desired electrode displacement in order to achieve desired ablation parameters, for example achieving desired electrode displacement, or desired displacement from or proximal to a target nerve.
  • the telescopic needle assembly may also be easier to manufacture as compared to bifurcated assembly, such that a first section may nest within a second section of the needle assembly.
  • a patient s physiological response to stimulation of the splanchnic nerve (or other target nerve).
  • a patient s response to a given stimulating amplitude may be suboptimal (e.g., poor spatial resolution).
  • it may be useful to localize the splanchnic nerve by stimulating the splanchnic nerve from a location along the azygous vein and sensing the resulting compound action potential (CAP) from within the intercostal vein off the azygous (e.g., using an electrode array placed within the intercostal vein off the azygous).
  • CAP compound action potential
  • FIGS. 30A-30B depict a catheter 3000 associated with a treatment device configured to perform such a procedure, according to an embodiment.
  • the catheter 3000 e.g., functionally and/or structurally the same as or similar to any of the catheters or devices described herein such as the device 200, the device 300, the device 400, and/or the device 2300
  • the catheter 3000 is configured to localize the splanchnic nerve) based on an observation of a physiological response to stimulation of the splanchnic nerve from a location along the azygos vein. The observation can be determined at or near an intercostal vein off the azygos vein.
  • the catheter 3000 includes a catheter tip 3002, distal electrodes 3010a, 3010b, a needle catheter 3020, a catheter shaft 3030 (shown as transparent in FIG. 30 A) defining one or more lumens, and proximal electrodes 3040a, 3040b.
  • the distal electrodes 3010a are between the catheter tip 3002 and the needle catheter 3020.
  • the components of the catheter 3000 can be similar functionally and/or structurally to the components of the device 200, the device 300, the device 400, the device 2300 and/or any other catheter or catheter component described herein.
  • the needle catheter 3020 is proximal to the catheter shaft 3030.
  • the catheter shaft 3030 includes at least one of a needle lumen (e.g., lumen for accepting a needle) and a guidewire lumen (e.g., lumen for accepting a guidewire).
  • the needle lumen is coupled to the needle catheter 3020 so that a needle can be extended out of an exit port of the needle catheter 3020 and access a target nerve.
  • the catheter shaft 3030 can be a hollow tube that is configured to house, protect, and/or insulate the one or more lumens.
  • the one or more lumens allow for positioning of the catheter 3000 to a desired location and for delivery a needle to a desired location for ablating the nerve.
  • the proximal electrodes 3040a, 3040b are located along the catheter shaft 3030.
  • the catheter 3000 includes both the distal electrodes 3010a, 3010b and the proximal electrodes 3040a, 3040b which allow for nerve stimulation and physiological response observation to occur at two different locations, thus increasing stimulating amplitude and spatial resolution.
  • the proximal electrodes 3040a, 3040b are configured to be situated near and operatively engage the azygos to provide stimulating energy.
  • the distal electrodes 3010a, 3010b are configured to be sensing electrodes configured to be situated near and operatively engage an intercostal vein off the azygous to measure a physiological response to the stimulating energy delivery by the proximal electrodes 3040a, 3040b.
  • the distal electrodes 3010a, 3010b are configured to sense the compound action potential (CAP).
  • the proximal electrodes 3040a, 3040b and/or the distal electrodes 3010a, 3010b can include additional electrodes for delivering energy and/or sensing physiological response.
  • the catheter 3000 is sized such that the splanchnic nerve can be located and targeted.
  • the distal electrodes 3010a, 3010b define a width LI of the electrodes.
  • the width LI in some embodiments, is between about 0.01 inches and about 0.1 inches, inclusive of all ranges and values therebetween. In some embodiments, the width LI is about 0.05 inches.
  • the distal electrodes 3010a, 3010b further define a distance L2 between the electrode 3010a and the electrode 3010b. In some embodiments, the distance L2 is between about 0.05 inches and about 0.3 inches, inclusive of all ranges and values therebetween. In some embodiments, the distance L2 is about 0.02 inches.
  • the electrode 3010b and the needle catheter 3020 define a distance L3 between them.
  • the distance L3 is between about 0.01 inches and about 0.5 inches, inclusive of all ranges and values therebetween. In some embodiments, the distance L3 is about 0.35 inches.
  • the proximal electrodes 3040a, 3040b define a width L4 of the electrodes.
  • the width LI in some embodiment is between about 0.01 inches and about 0.1 inches, inclusive of all ranges and values therebetween. In some embodiments, the width L4 is about 0.05 inches.
  • the needle catheter 3020 and the electrode 3040a define a distance L5 between them. In some embodiments, the distance L5 is between about 1 inch and 4 inches, inclusive of all ranges and values therebetween. In some embodiments, the distance L5 is about 2.5 inches.
  • the lengths and/or sizes described above are associated with the distance between the target nerve and an exit port of the needle catheter 3020 such that an ablation needle can be deployed in a desired location (e.g., in close proximity to the splanchnic nerve).
  • the distances LI, L2, and/or L3 may be interdependent to allow for desirable nerve ablation.
  • the distances LI, L2, and/or L3 can be selected such that the target nerve is disposed between (e.g., Ll+L3+(L2/2) would equal the lateral distance from the target nerve to the exit port from which the ablation needle extends) the distal electrodes 3010a, 3010b and the exit port so that the ablation probe can be best positioned to engage the target nerve.
  • an axial axis of the target nerve can pass between the distal electrode and the exit port.
  • the catheter can include more than one pair of distal electrodes and/or more than one pair of proximal electrodes.
  • each electrode pair may stimulate and/or measure / record (as described in further detail herein), to help indicate to what extent the catheter should be advanced or retracted to provide optimal alignment between the exit port and/or already advanced ablation probe and the target nerve.
  • any suitable number of electrodes, or electrode pairs may be used (e.g., one stimulating electrode and one sensing electrode, or three or more stimulating electrodes or sensing electrodes).
  • a grounding pad can be used on the skin of the patient. For example, if only one electrode is used, a grounding pad may be used as a reference. As another example, the grounding pad can be used in a bipolar arrangement to allow for a reference value, e.g., for use by an amplifier used to, e.g., acquire neurosensory signals.
  • FIG. 31 depicts a vascular catheter device engaging anatomy, the vascular catheter device configured to be functionally and/or structurally similar to a catheter with two sets of electrodes, such as the catheter 3000 of FIGS. 30A-30B.
  • the vascular catheter device of FIG. 31 includes two catheters, each with their own corresponding electrodes.
  • the catheter includes a set of distal electrodes 3110 and a set of proximal electrodes 3140 and is configured to deliver stimulation energy (e.g., via the proximal electrodes 3140) and measures the physiological response (e.g., via the distal electrodes 3110) across a target nerve 3150.
  • the stimulation electrode can delivery energy with a frequency of between about 4 Hz and about 3000 Hz, inclusive of all ranges and values therebetween. In some embodiments, the frequency is about 25 Hz. In some embodiments, frequency may exclude about 40 Hz to about 80 Hz to avoid interference from 60 Hz alternating current signals.
  • the set of distal electrodes 3110 can be used for providing stimulation energy and the set of proximal electrodes can be used for measuring the physiological response. In some embodiments, poles on an ablation probe (e.g., ablation needle) can be used for measuring the physiological response in response to a stimulation from the proximal electrodes 3140 and/or the distal electrode 3110.
  • monitoring the physiological response can include monitoring CAP signal and/or other parameters.
  • the other parameters can include time delay between stimulation and the resulting response monitoring signal, relative amplitude of the CAP signal to the stimulation signal, and/or the like.
  • the monitored response can be used to determine/confirm the location of the target nerve 3150. Once the location is confirmed, an ablation probe can be deployed and the location, in some embodiments, can be confirmed again using further stimulating energy.
  • the monitored response can be stored, recorded, an /or the like.
  • additional electrodes on the ablation probe and/or the catheter as well as the proximal electrodes 3140 and/or the distal electrodes 3110 can be used to determine additional response and/or baseline values (e.g., impedance values, etc.) that can be used to further confirm the location device relative to the target nerve 3150.
  • additional response and/or baseline values e.g., impedance values, etc.
  • the electrodes can be used to confirm effective ablation by providing stimulation energy and measuring the response (or lack thereof).
  • changes in electrical impedance values can be used to determine if ablation of the target nerve 3150 is successful.
  • stimulation energy can be used to monitor the ablation zone temperature and/or size. Monitoring ablation success can further be seen in FIG. 32, which depicts a CAP signal before ablation (signal 3210) and after ablation (signal 3220). As seen in FIG. 32, the signal 3210 includes peaks that are greater in amplitude than any peaks in signal 3220, thus indicating a successful ablation off the target nerve.
  • FIG. 33A depicts a device (e.g., functionally and/or structurally the same as or similar to any of the catheters or devices described herein such as the device 200, the device 300, the device 400, the device 2300, and/or the catheter 3000) including a catheter shaft 3330 (e.g., structurally and/or functionally similar to the catheter shaft 3030 and/or any catheter shaft described herein) a catheter tip (e.g., functionally and/or structurally similar to the catheter tip 3002 and/or any catheter tip described herein) distal to the catheter shafter 3330, and a needle catheter (e.g., functionally and/or structurally similar to the needle catheter 3020 and/or any needle catheter described herein) disposed between the catheter shaft 3330 and the catheter tip.
  • a catheter shaft 3330 e.g., structurally and/or functionally similar to the catheter shaft 3030 and/or any catheter shaft described herein
  • a catheter tip e.g., functionally and/or structurally similar to the catheter
  • the catheter shaft 3330 is disposable in a vein of the subject (i.e., the azygos vein) and the needle catheter and the catheter tip are disposable in an intercostal vein off the azygos.
  • the catheter tip includes distal electrodes 3310 (e.g., functionally and/or structurally similar to the distal electrodes 3010a, 3010b, the distal electrodes 3110 and/or any electrodes described herein) configured to span the splanchnic nerve.
  • the catheter shaft 3330 includes proximal electrodes 3340 (e.g., functionally and/or structurally similar to any of the proximal electrodes described herein).
  • the needle catheter includes a needle assembly 3350 (e.g., functionally and/or structurally similar to the needle assembly 206, the needle assembly 306, the needle assembly 406, the needle assembly 2313, the needle assembly 2500, the needle assembly 2600 and/or other needle assemblies described herein) configured to extend from the catheter 3330 and engaging the splanchnic nerve.
  • the proximal electrodes 3340 and the distal electrodes 3310 are configured to stimulate the splanchnic nerve and/or measure a response to a stimulation.
  • the needle assembly 3350 includes an ablation needle configured to ablate the splanchnic nerve. After ablation, the distal electrodes 3310 and/or the proximal electrodes 3340 can be used to determine if ablation is successful.
  • the catheter shaft 3330 can define a lumen and an exit port.
  • the exit port can be disposed between the first distal electrodes 3310 and the proximal electrodes 3340.
  • the catheter can be inserted through the azygous vein into an intercostal branching off of the azygous vein such that the distal electrodes are disposed within the intercostal vein adjacent the splanchnic nerve and the proximal electrodes are disposed within the azygous vein.
  • the ablation probe can be slidably disposed within the lumen and advanceable through the exit port of the catheter to pierce at least one of the azygous vein or the intercostal vein to ablate the splanchnic nerve.
  • a distance between the pair of stimulation electrodes is in a range between about 0.05 inches to about 0.15 inches, inclusive of all ranges and subranges therebetween.
  • a distance between the pair of sensing electrodes may be in a range between about 0.025 inches to about 0.10 inches, inclusive of all ranges and subranges therebetween.
  • a distance between a center point between the pair of stimulation electrodes and a center point between the pair of sensing electrodes may be in a range between about 3 cm to about 5 cm, inclusive of all ranges and subranges therebetween.
  • the pair of stimulation electrodes and the pair of sensing electrodes may have a distance therebetween such that the pair of sensing electrodes receive sufficient signal in response to stimulation.
  • the stimulation electrodes may include a dielectric coating disposed over a section thereof (e.g., an insulated portion or a non-conductive portion). Therefore, a conductive portion of the stimulation electrodes and/or the sensing electrodes may not fully extend around the circumference of the catheter.
  • the dielectric coating may impart a directionality on the stimulation electrodes and/or the sensing electrodes. For example, the dielectric coating disposed on the stimulation electrodes may attenuate stimulation energy through the portion of stimulation electrodes that is coated (or the non-conductive portion).
  • stimulation energy directed toward the spinal column may be attenuated by the dielectric layer, and the stimulation energy directed toward the target nerve may not be attenuated.
  • dielectric coating disposed on the sensing electrodes may attenuate a signal strength of the evoked CAP response when the catheter is not rotated in a desired orientation.
  • the conductive portion of the sensing electrodes may be on a first side of the catheter to be oriented toward the target nerve (e.g., the side including the exit port), and the dielectric coating may be disposed on a second side of the catheter opposite the first side (e.g., the side opposite the exit port).
  • a lower signal strength of the evoked CAP response may indicate that the catheter is oriented incorrectly (i.e., the exit port is facing away from the target nerve).
  • a larger signal strength of the evoked CAP and/or the signal exceeding a predetermined threshold may indicate that the catheter is oriented properly relative to the target nerve (i.e., the exit port faces the target nerve).
  • the dielectric coating may allow the user to properly orient the catheter within the vein relative to the target nerve such that the ablation probe can be extended in the desired direction toward the target nerve.
  • the orientation of the catheter relative to the target nerve can be determined based on an amplitude of the resultant signal measured.
  • a single catheter can contain both stimulation and sensing electrodes
  • the system can include two catheters.
  • the system may include a first catheter including a first set of electrodes configured to stimulate a nearby nerve (e.g., the splanchnic nerve) and a second catheter including a second set of electrodes (i.e., nerve localization electrodes) configured to sense the resulting CAP following through the nerve.
  • the second catheter may include an ablation probe. Therefore, signals sensed by the second set of electrodes can be used to determine a placement of the ablation probe in close proximity to a target nerve.
  • the ablation probe may be slidable disposed through a lumen of the second catheter and configured to exit the second catheter at a distal tip thereof.
  • the second set of electrodes may be disposed near a distal tip of the second catheter to localize where the ablation probe exits the second catheter.
  • any of the features described herein with respect to FIG. 33A may be applicable to any of the devices described herein such as the device 200, the device 300, the device 400, the device 2300, and/or the catheter 3000.
  • FIG. 33B depicts the device shown in FIG. 33A, disposed within an azygos vein with its distal portion (e.g., catheter tip) within an intercostal vein adjacent to and operatively engaging a splanchnic nerve.
  • the proximal electrodes 3340 may be configured to deliver the stimulation energy while the distal electrode 3310 are configured to measure a physiological response.
  • the distal electrodes 3310 may be configured to deliver the stimulation energy while the proximal electrodes 3340 are configured to measure the physiological response.
  • the device can include additional electrodes that are configured to deliver energy and/or measure physiological response.
  • the additional electrodes can be disposed on or otherwise coupled to or included within the ablation probe.
  • any combination of electrodes can be used provide stimulation energy and/or to measure a resultant signal or physiological response, to one or more of (1) determine a position of the device (or any of its components) within the anatomy or relative to the splanchnic nerve before, during, and/or after ablation, or (2) determine effectiveness (or lack thereof) of ablation of the splanchnic nerve using the ablation probe.
  • the position of the catheter can be determined based on at least one of (1) a time delay between delivering stimulation energy and measuring the resultant signal, or (2) an amplitude associated with the resultant signal.
  • any combination of the electrodes described above can be used to establish base-line electrical impedance values between the various electrodes, and changes in the electrical impedance can be monitored before, during, and/or after ablating the splanchnic nerve; in this manner, in some instances, such monitoring can be representative of ablation zone temperature and/or size, to assist the operator during and/or after the ablation procedure.
  • impedance can be taken between any two electrodes on the device and the change in impedance can be used to determine a shape and/or size of an ablated region.
  • the device can be coupled to a control system configured to determine a position of the catheter within the subject based on the resultant signal.
  • the additional electrodes (i.e., a third set of electrodes) on the ablation probe can include at least one ablation electrode configured to deliver radiofrequency to a target nerve (e.g., the splanchnic nerve).
  • the ablation probe can be configured to pierce the vein (e.g., the azygous vein or the intercostal vein) such that the ablation probe can be advanced through a vessel wall and toward the target nerve (e.g., the splanchnic nerve).
  • the devices described herein can include a needle with an outer diameter of about 0.025 inches.
  • the core wire can be formed of any suitable material such as nitinol, stainless steel, Lenz wire, and/or the like.
  • the core wire can be formed of a multistranded Lenz wire that can reduce resistive heating generated by passing RF signals through a larger diameter conduit.
  • FIG. 34 depicts nerve activity of a target nerve measured at a pair of sensing electrodes in response to a stimulation pulse before and after ablation of the target nerve. The nerve activity measured before ablation is shown as the signal 3502, and the nerve activity measured after ablation is shown as the signal 3504.
  • the evoked CAP occurs between about 22 ms to about 24 ms after the stimulation pulse is delivered.
  • the timing of the action potential in response to stimulation can be estimated based on a conduction velocity of the nerve and the known distance between the stimulation electrodes and the sensing electrodes.
  • an estimated time window of the evoked CAP can be monitored and compared before ablation and after ablation.
  • the pre-ablation evoked CAP has an amplitude of about 65 millivolts (mV)
  • the post-ablation evoked CAP has an amplitude of about 33.3 mV.
  • the amplitude of the evoked CAP decreases by about 49% after the nerve ablation procedure, indicating that the nerve has been successfully ablated.
  • the nerve ablation procedure can result in a decrease in amplitude of the evoked CAP in a range between about 25% and about 100%, inclusive of all ranges and subranges therebetween.
  • the nerve ablation procedure can result in a decrease in amplitude of the evoked CAP in a range between about 30 and about 60%, inclusive of all ranges and subranges therebetween.
  • Example 1 Nerve Ablation Catheter with Bifurcated Needle Assembly
  • a vascular catheter device comprising a needle assembly.
  • the device comprises a device body (e.g., catheter body) 210, a catheter tip 202, a needle assembly 206 configured to be disposed within the catheter body, an opening 208 for the needle assembly 206 to extend from, and an electrode region 207 (e.g., for neurostimulation).
  • the opening 208 is a lateral opening, and the device body 210 has a longitudinal axis (203).
  • the electrode region is also the same location as a neurosensory region (e.g., for measuring action potentials), which can be located anywhere on the catheter body 210.
  • the device comprises a radiopaque area 204, which may be used to help track the location of the device within a subject.
  • the radiopaque area is located anywhere on the catheter body and helps enable rotational accuracy for positioning the needle assembly (as described herein).
  • the device further comprises radiopaque marks at different locations on the catheter body at 90 degree increments, thereby helping direct the needle assembly in the superior/inferior, anterior/posterior, lateral/medial, and/or cranial/caudal directions.
  • the device body further comprises a needle lumen which extends within the device body and terminates at a lateral opening.
  • the needle assembly comprises two needle-electrodes each comprising a separate needle.
  • a needle assembly push stem (or other structure) is provided within the catheter body 210 and configured to engage with the needle assembly so as to push the needle assembly 206 through the opening 208.
  • the push stem is located within the catheter body 210 and configured to be actuated so as to automatically push the needle assembly 206 out of the opening 208 when actuated by the user by an actuation member on the handle device.
  • the needle assembly 206 is provided within a needle assembly tube located within the catheter body 210. The tube is configured to extend from the opening 208 to the vein wall, wherein the needle assembly is then configured to be extend from an end of the tube and puncture through the vein wall.
  • the catheter body 310 is configured to rotate so as to orient the needle assembly 306 in a prescribed direction relative to the target nerve.
  • the needle assembly is configured to extend from the catheter body according to a specific configuration, which corresponds to the location of a radiopacity marker (e.g., 304), such that the direction and position of the electrodes on the needle assembly when extended can be correlated with the location of the radiopacity marker, radiopacity helps enable rotational accuracy for positioning the needle assembly (as described herein).
  • the radiopaque mark appears different on the catheter body at 90 degree increments, thereby helping direct the needle assembly in the superior/inferior, anterior/posterior, lateral/medial, and/or cranial/caudal directions
  • the electrodes 212, 213 are configured to ablate (e.g., circumferentially lyse) a length of the target nerve that is at least the length from target nerve location 220 to target nerve location 221.
  • the target nerve circumference 220, 221 represents the ablation area (at a given location), and the portion of the target nerve between portions 220, 221 represents the length of the ablation area.
  • the longer the length of the ablation area provides for a longer treatment period for a medical condition described herein (e.g., heart failure).
  • a vascular catheter device comprising a needle assembly.
  • the device comprises a catheter shaft 2311, a handle 2306, a contrast port 2301, a guidewire port 2302, a catheter rotation knob 2303, an electrode advancer 2304, a rotary electrical connector 2305, a catheter tip 2316, an ablation needle exit port 2312, an ablation needle lumen 2314, a guidewire lumen 2318, a maker band 2317, two marker bands 2315, and a silk-screened electrode 2313 (e.g., for neurostimulation).
  • the telescopic needle assembly with one or more electrodes may be extended 2319 as shown in FIG. 23B.
  • the telescopic needle assembly comprises a first section surrounding a second section, wherein the second section extends outwards from the first section.
  • the first section comprises a first tubular body
  • the second section comprises a second tubular body, wherein the first tubular body extends outward from the second tubular body, and wherein the first tubular body nests within the second tubular body such that the tubular body is fully or partially contained within the first tubular body.
  • the needle assembly further comprises a third section comprising a sharp distal point, wherein the second section surrounds the third section, wherein the third section extends outward from the second section.
  • the catheter, ablation needle, guidewire port 2302, contrast port 2301, and rear connector 2305 spin in unison.
  • a guidewire may be inserted into the guidewire port 2302 which drives the catheter in the vascular tissue.
  • the contrast port 2302 is used for fluoroscopic contrast.
  • the rear connector includes pins for two ablation poles and three nerve stimulation and nerve monitoring leads.
  • the key way within the handle 2306 couples the rotation of the control knob and control catheter with the rear electrical connector and routes electrical connections to allow for continuous rotation.
  • the electrode advancer provides sufficient travel for the distal end of the ablation needle to extend about 1.5cm from the catheter midline.
  • the electrode advancer 2304 is used to extend the electrode assembly into vascular tissues, e.g., to puncture a vascular lumen which the catheter is within, and the extension length of the telescopic electrode assembly can be controlled by the user.
  • the guidewire is inserted into the guidewire lumen to advance the catheter tip 2316 into an intravascular space.
  • the electrode advancer advances the outermost electrode and then a second portion extends from the first portion.
  • the guidewire is advances separately from the electrode.
  • the rear electrical connector has three pins for nerve sensing and two bi-polar ablation poles.
  • the catheter length is about 120 cm. In some embodiments, the catheter length is about 90 cm.
  • the catheter length is between about 90 cm and about 120 cm.
  • the nerve sensing elements are electrodes 2313 on the catheter shaft substrate wrapped around the catheter shaft 2311 and bonded in place.
  • the one or more electrodes on the needle assembly is used to confirm placement of the needle prior to ablation via low power stimulation to observe the patient’s heart rate.
  • the device comprises a radiopaque area 404, which may be used to help track the location of the device within a subject.
  • the radiopaque area is located anywhere on the catheter body.
  • radiopacity helps enable rotational accuracy for positioning the needle assembly (as described herein).
  • the radiopaque mark appears different on the catheter body at 90 degree increments, thereby helping direct the needle assembly in the superior/inferior, anterior/posterior, lateral/medial, and/or cranial/caudal directions.
  • an electrical charge is delivered from a first electrode, which can be positive, to a second electrode, thereby sending energy to nearby vascular tissue and heating it to approximately 40 C, 50 C, or 60 C.
  • a needle assembly push stem (or other structure) is provided within the catheter shaft 2311 and configured to engage with the needle assembly so as to push the needle assembly 2500, or, in other embodiments, needle assembly 2600, through the ablation needle exit port 2315.
  • the push stem is located within the catheter shaft 2311 and configured to be actuated so as to advance the needle assembly 2500, or, in other embodiments, needle assembly 2600, out of the ablation needle exit port 2315 when actuated by the user by an actuation member on the handle device.
  • the needle assembly 2500, or, in other embodiments, needle assembly 2600 is provided within a catheter assembly tube located within the catheter shaft 2311.
  • the electrode within needle assembly 2500, or, in other embodiments, needle assembly 2600 is configured to extend from the ablation needle exit port 2315 to the vein wall, wherein the needle assembly is then configured to extend from an end of the tube and puncture through the vein wall.
  • the catheter shaft 2311 is configured to rotate so as to orient the needle assembly 2500, or, in other embodiments, needle assembly 2600, in a prescribed direction relative to the target nerve.
  • the needle assembly is configured to extend from the catheter body according to a specific configuration, which corresponds to the location of a radiopacity marker (e.g., 304), such that the direction and position of the electrodes on the needle assembly when extended can be correlated with the location of the radiopacity marker, radiopacity helps enable rotational accuracy for positioning the needle assembly (as described herein).
  • the radiopaque mark appears different on the catheter body at 90 degree increments, thereby helping direct the needle assembly in the superior/inferior, anterior/posterior, lateral/medial, and/or cranial/caudal directions
  • the electrode configuration 2700 is configured to ablate (e.g., circumferentially lyse) a length of the target nerve. As described herein, the longer the length of the ablation area provides for a longer treatment period for a medical condition described herein (e.g., heart failure).
  • a medical condition described herein e.g., heart failure
  • the telescopic needle assembly may result in improved ablation, reduction of trauma to vascular tissue and tissue surrounding the target nerve, smoother insertion and retraction the needle assembly, ease of manufacture, and increased control of ablation parameters and ablation length.
  • the telescopic configuration of the needle assembly minimizes sharp force trauma to vascular tissue which it is penetrating, and other tissue surrounding the target nerve, when it is extended, as it extends in a straight (or relatively straight) vector which will not displace tissue adjacent to the telescopic needle assembly.
  • the telescopic has a greater tendency to properly extend and retract without trapping vascular tissue within the needle assembly or in between components of the needle assembly as compared to the bifurcating configuration.
  • the length of extension of the telescopic needle assembly comprising the electrode assembly can be controlled by the operator, and the displacement between the electrodes on the telescopic needle assembly can be varied, permitting for increased ablation length for configurations with a larger displacement between the electrodes, or reduced ablation length for configurations with a smaller displacement between the electrodes.
  • the ease of extension of the telescopic needle assembly improves the operator’ s ability to achieve or maintain a desired electrode displacement relative to each electrode in order to achieve desired ablation parameters, for example achieving desired electrode displacement.
  • telescopic needle assembly improves the operator’s ability to achieve the or desired displacement from or proximal to a target nerve by permitting the operator to vary the insertion depth of the telescopic needle assembly.
  • these features may permit for a surgeon to account for varying patient anatomy with the telescopic needle assembly.
  • the telescopic needle assembly may also be easier to manufacture as compared to bifurcated assembly, such that a first section may nest within a second section of the needle assembly.
  • a patient with treatment-resistant heart failure presents to a cardiology clinic.
  • the patient expresses to the physician that they do not have the energy level they used to and frequently feels “winded” or “short of breath” after minimal physical activity, such as walking one city block, or going up or down one flight of stairs.
  • the patient may have been previously evaluated by other physicians and then referred to cardiology clinic.
  • the patient displays other symptoms indicative of heart failure, for example, early fatigue, orthopnea, paroxysmal nocturnal dyspnea, dyspnea on exertion, or tachycardia episodes.
  • the patient reports being able to walk a mile or more without experiencing the complained of symptoms.
  • This patient is already on Lasix (diuretics or water pills), blood pressure medications, generic equivalents, or combinations thereof, but there is no improvement to the complained of symptoms. There are no additional options for pharmacotherapy at this time.
  • the physical exam shows evidence of volume overload (fluid in the lungs, swelling in the legs, elevated jugular vascular pressure/pulsations).
  • the cardiologist notes the patient is a New York Heart Association (NYHA) Class II or Class III severity patient, depending on the level of exercise capacity.
  • NYHA New York Heart Association
  • Other criteria or indicators of HF severity include brain naturistic peptide levels and number of hospitalizations over a recent time frame (at least 1 admission over the past year).
  • This patient may or may not have usual comorbidities of hypertension, kidney disease, liver disease, high cholesterol, and diabetes, among other issues.
  • the cardiologist then refers the patient for a splanchnic nerve ablation procedure, which will take place in the outpatient catheterization lab affiliated with the clinic.
  • a catheter-based device as described in Example 2 is utilized.
  • the catheter device accesses the vascular system via Seidinger technique through the jugular vein.
  • the access sheath is navigated to the superior vena cava under fluoroscopic guidance.
  • the sheath will cannulate that as it goes vein from the superior vena cava, and a guidewire will traverse that azygos vein.
  • the sheath will cannulate the azygos vein from the superior vena cava, and a guidewire will traverse the azygos vein.
  • T9 the guidewire can enter the left and/or right intercostal vein branch.
  • the greater splanchnic nerve (GSN) is assumed to be nearby, and the device will be introduced over the guidewire to this location.
  • the device When the device has reached the location by anatomic landmarks observable on fluoroscopy (bones, vessels, etc.), which may be confirmed by using the marker bands of the catheter device — optionally — proximity to the target nerve is confirmed by applying a stimulation energy at the location and measuring a physiological response to the stimulation, for example, muscle response in the abdomen or GI track, nerve activity, or cardiac activity.
  • a stimulation energy at the location and measuring a physiological response to the stimulation, for example, muscle response in the abdomen or GI track, nerve activity, or cardiac activity.
  • the operator will use the device’s neurostimulatory component to deliver a charge through electrodes strong enough to elicit a nerve response, but not strong enough to damage tissue.
  • PCWP pulmonary capillary wedge pressures
  • gastrointestinal changes including increased motility, changes in less palmer sweating, changes in temperature for rectal and/or skin measurement, in renal output in relation to changes in vascular dilation, changes in metabolism (i.e. decreased glucose and glucagon release) and increases in brain natriuretic peptide.
  • the Swan Ganz catheter has a balloon, which is inflated, that is threaded through to the superior vena cava, the right atrium, the right ventricle to the pulmonary outflow tract.
  • the inflated balloon carries the catheter to a pulmonary artery, where it is wedged.
  • pressures detected are called pulmonary capillary wedge pressures, which are considered equivalent to left atrial pressures.
  • Left atrial pressures are a surrogate measurement for left ventricular end-diastolic pressures.
  • PCWP is a measurement of severity of heart failure. Higher PCWP indicates worsened severity of heart failure.
  • Each of the other responses will be measured by specific aspects of devices.
  • the operator may, optionally, also use another component of the device to directly sense the nerve, using the same electrodes that the neurostimulatory component employs.
  • the device generator When the operator is able to position the device to the approximate location of the GSN using anatomic landmarks, the device generator will be changed to a “nerve sensing” mode.
  • the nerve sensing mode will use the electrodes to read for action potentials through the GSN.
  • the electrodes may be separate electrodes located on the surface of the catheter device or may be the one or more electrodes within the needle assembly. Data from the neurostimulatory component and the nerve sensing apparatus will be aggregated to tell the operator that the device is in the position to perform nerve destruction.
  • the vascular puncture mechanism is actuated in the direction of the nerve to perform the ablation.
  • the puncture mechanism may optionally confirm the position using a combination of nerve-sensing, neurostimulation with physiologic response, and fluoroscopy identifying anatomic landmarks, as described herein.
  • the nerve is ablated with radiofrequency ablation by applying an electrical stimulation to the electrode assembly.
  • Electrical energy at less than or equal to about 15 W is transmitted from the power source to the electrode assembly on the needle assembly in proximity to the target nerve, and heating the target nerve and surrounding tissue to approximately 90 C.
  • procedure success may be evaluated by repeating the combination of nerve-sensing, neuro-stimulation with physiologic response.
  • the device s neurostimulatory component delivers a charge through electrodes strong enough to elicit a nerve response, but not strong enough to damage tissue.
  • the sympathetic response of the GSN will be measured by physiological changes as described above.
  • the nerve-sensing component will detect lack of nerve activity, indicating the nerve has successfully been circumferentially lysed.
  • the procedure will be considered incomplete if there is a physiologic response and/or if there is nerve activity sensed by the catheter device.
  • the procedure will be repeated to lyse the nerve circumferentially, at the same site or a different site between two intercostal pairs.
  • the patient is re-evaluated in the clinic one month later.
  • the patient is noted to have more energy and exercise level; he/she can walk more than one block of stairs without having to rest.
  • the cardiologist notes that the patient is improved one NYHA Class of severity with fewer hospitalizations.
  • a patient is hospitalized for heart failure exacerbation due to volume overload and has had repeated admissions in the recent past. He/she requires respiratory support (i.e. oxygen, external ventilation, or intubation) and is on intravascular diuretic therapy to remove excess fluid. Other standard treatments are included. This patient may or may not have usual comorbidities of hypertension, kidney disease, liver disease, high cholesterol, and diabetes, among other issues. In this case, the intravascular treatment is not able to remove fluid well, and the patient still shows signs of volume overload, and/or respiratory failure. The decision is made to perform the splanchnic nerve ablation procedure, while hospitalized.
  • a catheter-based device as described in Example 2 is utilized.
  • the catheter device accesses the vascular system via Seidinger technique through the jugular vein.
  • the access sheath is navigated to the superior vena cava under fluoroscopic guidance.
  • the sheath will cannulate that as it goes vein from the superior vena cava, and a guidewire will traverse that azygos vein.
  • the sheath will cannulate the azygos vein from the superior vena cava, and a guidewire will traverse the azygos vein.
  • T9 the guidewire can enter the left and/or right intercostal vein branch.
  • the greater splanchnic nerve (GSN) is assumed to be nearby, and the device will be introduced over the guidewire to this location.
  • the device When the device has reached the location by anatomic landmarks observable on fluoroscopy (bones, vessels, etc.).), which may be confirmed by using the marker bands of the catheter device — optionally — proximity to the target nerve is confirmed by applying a stimulation energy at the location and measuring a physiological response to the stimulation, for example, muscle response in the abdomen or GI track, nerve activity, or cardiac activity.
  • a stimulation energy at the location and measuring a physiological response to the stimulation, for example, muscle response in the abdomen or GI track, nerve activity, or cardiac activity.
  • the operator will use the device’s neurostimulatory component to deliver a charge through electrodes strong enough to elicit a nerve response, but not strong enough to damage tissue.
  • PCWP pulmonary capillary wedge pressures
  • gastrointestinal changes including increased motility, changes in less palmer sweating, changes in temperature for rectal and/or skin measurement, in renal output in relation to changes in vascular dilation, changes in metabolism (i.e. decreased glucose and glucagon release) and increases in brain natriuretic peptide.
  • the Swan Ganz catheter has a balloon, which is inflated, that is threaded through to the superior vena cava, the right atrium, the right ventricle to the pulmonary outflow tract.
  • the inflated balloon carries the catheter to a pulmonary artery, where it is wedged.
  • pressures detected are called pulmonary capillary wedge pressures, which are considered equivalent to left atrial pressures.
  • Left atrial pressures are a surrogate measurement for left ventricular end-diastolic pressures.
  • PCWP is a measurement of severity of heart failure. Higher PCWP indicates worsened severity of heart failure.
  • Each of the other responses will be measured by specific aspects of devices.
  • the operator may, optionally, also use another component of the device to directly sense the nerve, using the same electrodes that the neurostimulatory component employs.
  • the device generator When the operator is able to position the device to the approximate location of the GSN using anatomic landmarks, the device generator will be changed to a “nerve sensing” mode.
  • the nerve sensing mode will use the electrodes to read for action potentials through the GSN.
  • the electrodes may be separate electrodes located on the surface of the catheter device or may be the one or more electrodes within the needle assembly. Data from the neurostimulatory component and the nerve sensing apparatus will be aggregated to tell the operator that the device is in the position to perform nerve destruction.
  • the vascular puncture mechanism is actuated in the direction of the nerve to perform the ablation.
  • the puncture mechanism may optionally confirm the position using a combination of nerve-sensing, neurostimulation with physiologic response, and fluoroscopy identifying anatomic landmarks.
  • the nerve is ablated with radiofrequency ablation by applying an electrical stimulation to the electrode assembly.
  • Electrical energy at less than or equal to about 15 W is transmitted from the power source to the electrode assembly on the needle assembly in proximity to the target nerve, and heating the target nerve and surrounding tissue to approximately 90 C.
  • procedure success may be evaluated by repeating the combination of nerve-sensing, neuro-stimulation with physiologic response.
  • the device s neurostimulatory component delivers a charge through electrodes strong enough to elicit a nerve response, but not strong enough to damage tissue.
  • the sympathetic response of the GSN will be measured by physiological changes as described above.
  • the nerve-sensing component will detect lack of nerve activity, indication the nerve has successfully been circumferentially lysed.
  • the procedure will be considered incomplete if there is a physiologic response and/or if there is nerve activity sensed by the catheter device.
  • the procedure will be repeated to lyse the nerve circumferentially, at the same site or a different site between two intercostal pairs.
  • the volume status of the patient improves and the patient is re-evaluated in the clinic one month later.
  • the patient is noted to have more energy and exercise level; he/she can walk more than one block of stairs without having to rest.
  • the cardiologist notes that the patient is improved one NYHA Class of severity with fewer hospitalizations.
  • Example 5 Inpatient Treatment of Heart Failure with Alternative Surgical Method
  • a patient is hospitalized for heart failure exacerbation due to volume overload and has had repeated admissions in the recent past. He/she requires respiratory support (i.e. oxygen, external ventilation, or intubation) and is on intravascular diuretic therapy to remove excess fluid. Other standard treatments are included. This patient may or may not have usual comorbidities of hypertension, kidney disease, liver disease, high cholesterol, and diabetes, among other issues. In this case, the intravascular treatment is not able to remove fluid well, and the patient still shows signs of volume overload, and/or respiratory failure. The decision is made to perform the splanchnic nerve ablation procedure, while hospitalized.
  • respiratory support i.e. oxygen, external ventilation, or intubation
  • intravascular diuretic therapy to remove excess fluid.
  • Other standard treatments are included. This patient may or may not have usual comorbidities of hypertension, kidney disease, liver disease, high cholesterol, and diabetes, among other issues.
  • the intravascular treatment is not able to remove fluid well, and the patient still shows signs of volume overload,
  • a catheter-based device as described in Example 2 is utilized.
  • the catheter device accesses the vascular system via Seidinger technique through the brachial, femoral, or subclavian vein.
  • the catheter device may be elongated proportionally to the vein chosen for entry.
  • the access sheath is navigated to the superior vena cava under fluoroscopic guidance.
  • the sheath will cannulate that as it goes vein from the superior vena cava, and a guidewire will traverse that azygos vein.
  • the sheath will cannulate the azygos vein from the superior vena cava, and a guidewire will traverse the azygos vein.
  • the device is rotated towards the patient’s right side such that the needle is towards the patient’s right side, using the radiographic marker to confirm position and orientation.
  • the guidewire can enter between two intercostal pairs, for example, T9 and T10, T10 and Ti l, Ti l and T12, and/or T12 and LI.
  • GSN greater splanchnic nerve
  • the device When the device has reached the location by anatomic landmarks observable on fluoroscopy (bones, vessels, etc.) which may be confirmed by using the marker bands of the catheter device — optionally — proximity to the target nerve is confirmed by applying a stimulation energy at the location and measuring a physiological response to the stimulation, for example, muscle response in the abdomen or GI track, nerve activity, or cardiac activity.
  • a stimulation energy at the location and measuring a physiological response to the stimulation, for example, muscle response in the abdomen or GI track, nerve activity, or cardiac activity.
  • the operator will use the device’s neurostimulatory component to deliver a charge through electrodes strong enough to elicit a nerve response, but not strong enough to damage tissue.
  • the sympathetic response of the GSN will be measured by detecting adverse changes in pulmonary capillary wedge pressures (PCWP), gastrointestinal changes including increased motility, changes in less palmer sweating, changes in temperature for rectal and/or skin measurement, in renal output in relation to changes in vascular dilation, changes in metabolism (i.e. decreased glucose and glucagon release) and increases in brain natriuretic peptide.
  • PCWP pulmonary capillary wedge pressures
  • Left atrial pressures are a surrogate measurement for left ventricular end-diastolic pressures.
  • PCWP is a measurement of severity of heart failure. Higher PCWP indicates worsened severity of heart failure.
  • the operator may, optionally, also use another component of the device to directly sense the nerve, using the same electrodes that the neurostimulatory component employs.
  • the device generator When the operator is able to position the device to the approximate location of the GSN using anatomic landmarks, the device generator will be changed to a “nerve sensing” mode.
  • the nerve sensing mode will use the electrodes to read for action potentials through the GSN.
  • the electrodes may be separate electrodes located on the surface of the catheter device or may be the one or more electrodes within the needle assembly. Data from the neurostimulatory component and the nerve sensing apparatus will be aggregated to tell the operator that the device is in the position to perform nerve destruction.
  • the vascular puncture mechanism is actuated in the direction of the nerve to perform the ablation.
  • the puncture mechanism may optionally confirm the position using a combination of nerve-sensing, neurostimulation with physiologic response, and fluoroscopy identifying anatomic landmarks.
  • the nerve is ablated with radiofrequency ablation by applying an electrical stimulation to the electrode assembly.
  • Electrical energy at less than or equal to about 15 W is transmitted from the power source to the electrode assembly on the needle assembly in proximity to the target nerve, and heating the target nerve and surrounding tissue to approximately 90 C.
  • procedure success may be evaluated by repeating the combination of nerve-sensing, neuro-stimulation with physiologic response.
  • the device s neurostimulatory component delivers a charge through electrodes strong enough to elicit a nerve response, but not strong enough to damage tissue.
  • the sympathetic response of the GSN will be measured by physiological changes as described above.
  • the nerve-sensing component will detect lack of nerve activity, indication the nerve has successfully been circumferentially lysed.
  • the procedure will be considered incomplete if there is a physiologic response and/or if there is nerve activity sensed by the catheter device.
  • the procedure will be repeated to lyse the nerve circumferentially, at the same site or a different site between two intercostal pairs.
  • the volume status of the patient improves and the patient is re-evaluated in the clinic one month later.
  • the patient is noted to have more energy and exercise level; he/she can walk more than one block of stairs without having to rest.
  • the cardiologist notes that the patient is improved one NYHA Class of severity with fewer hospitalizations.
  • a first vascular catheter device comprising a telescopic needle assembly
  • a telescopic needle assembly comprising an ablation needle, two electrodes separated by a PEEK pole separator, an end cap, a core wire, a rotation coupler, and a proximal laser cut hypotube was provided.
  • the needle had an outer diameter of about 0.025 inches, wherein each electrode had a length of about 0.33 inches.
  • the end cap and the core wire were made of stainless steel, wherein the core wire has a diameter of about 0.007 inches and is coated with a Polyimide inner insulating jacket.
  • the distal and proximal poles were measured to have a resistance of about 62 ohms, and about 12.8 ohms, respectively.
  • a second vascular catheter device comprising a telescopic needle assembly
  • a telescopic needle assembly comprising an ablation needle, two electrodes separated by a PEEK pole separator, an end cap, a core wire, a rotation coupler, and a proximal laser cut hypotube was also provided, however it differed as to the outer diameter of the telescopic needle assembly, the length of the electrodes on the telescopic needle assembly, and the distal and proximal pole resistance.
  • the needle had an outer diameter of about 0.018 inches, wherein each zone has a length of about 0.39 inches.
  • the core wire is formed of nitinol and has a diameter of about 0.007 inches and is coated with a Polyimide inner insulating jacket.
  • the rotational coupler was formed of Pebax and polyimide
  • the distal and proximal poles were measured to have a resistance of about 42.5 ohms, and about 44.8 ohms, respectively.
  • the first vascular catheter device and second vascular catheter device each comprising a telescopic needle assembly was tested in a poultry tissue model, and the efficacy of the tissue ablation resulting from the improved electrode design was assessed.
  • the telescopic needle assembly was inserted into a chicken breast and electrical energy was delivered to the electrodes. After applying 8 W for about 30 seconds, no audible sounds of water vaporization or signs of plasma generation were recorded and the laser scribed hypotube was smoothly removed without tissue adhesion. After applying 9 W for about 30 seconds, no audible sounds of water vaporization or signs of plasma generation were recorded and the laser scribed hypotube was removed with only slight tissue adhesion. Audible sounds of water vaporization were recorded after 27 seconds of applying 10 W without signs of plasma generation, wherein small chunks of tissue adhered to the laser scribed hypotube after extraction.
  • the first nerve ablation catheter herein is able to sufficiently ablate tissue, without plasma-induced char damage, and can be removed from the tissue without damaging tissue surrounding the ablation area.
  • the first vascular catheter device despite having a shorter electrode surface length which defines a shorter ablation zone (8.4 mm) than the second vascular catheter device (9.9 mm), forms 22% longer ablation zones with a 55% larger diameter than the ablation zones formed by the second vascular catheter device. As such, the first vascular catheter device exhibits 195% the ablation zone compared with the second vascular catheter device (1016 mm 3 for the first catheter vs.
  • the improved ablation volume provided by the first vascular catheter device with the increased surface area thus provides the surgeon greater flexibility in conducting the ablation procedure, permitting for a comparatively larger volume to be ablated over a longer time period, while also reducing tissue adhesion to the ablation needle which poses a significant post-ablation risk of injury upon needle retraction.
  • Example 7 Nerve Ablation Catheter with Telescopic Needle Assembly Having Increased Needle Lumen Curvature, and Linear Guidewire Lumen
  • a first vascular catheter device comprising a telescopic needle assembly
  • a telescopic needle assembly comprising an ablation needle, two electrodes separated by a PEEK pole separator, an end cap, a core wire, a rotation coupler, and a proximal laser cut hypotube was provided.
  • the vascular catheter device comprises a needle assembly lumen having a 0.033 inch inner diameter and a 0.09 inch radius of curvature which the telescopic needle assembly extends from, and linear guidewire lumen coextensive with a portion of the needle assembly lumen.
  • the resulting exit port of the needle assembly lumen is positioned at a substantially orthogonal angle.
  • the first vascular catheter device further comprises a tubular body is configured to bias the vascular catheter against the single direction of extension and prevent movement of the vascular catheter within vascular tissue when extending the telescopic needle assembly.
  • a second vascular catheter device comprising a telescopic needle assembly
  • a telescopic needle assembly comprising an ablation needle, two electrodes separated by a PEEK pole separator, an end cap, a core wire, a rotation coupler, and a proximal laser cut hypotube was provided.
  • the vascular catheter device comprises a needle assembly lumen having a 0.03 inch inner diameter with a 0.055 inch radius of curvature which the telescopic needle assembly extends from, and linear guidewire lumen coextensive with a portion of the needle assembly lumen.
  • the resulting exit port of the needle assembly lumen is positioned at an angle which is less orthogonal than the first vascular catheter device.
  • the delivery of the catheter devices is tested in a porcine model.
  • the catheter is placed by movement of a guidewire about the guidewire lumen. It is observed that the first vascular catheter device having a linear guidewire lumen coextensive with a portion of the needle assembly lumen is more easily positioned and guided into place as a result of the linear guidewire lumen which does not require the guidewire to bend within the shaft as force is provided to the catheter device and it is advanced through a vein, as compared to the non-linear portion guidewire lumen of the second catheter device which requires the guidewire to bend within the shaft as force is provided to the catheter device and it is advanced through a vein.
  • EMBODIMENT 1 comprising a device for treating a medical condition, the device comprising: a catheter having a longitudinal axis and comprising a needle lumen therein that is substantially parallel to or substantially coincident with the catheter longitudinal axis, wherein the needle lumen terminates in a lateral opening at a distal portion of the catheter; and a needle assembly configured to extend within and/or from the needle lumen, the needle assembly comprising: a first needle having a first tip and a second needle having a second tip, wherein the first needle and the second needle are disposed at a needle assembly distal end, the needle assembly having A) a non-bifurcated configuration prior to at least partially extending from the needle lumen and/or the lateral opening, and B) a bifurcated configuration when at least partially extending from the needle lumen and the lateral opening, wherein when the needle assembly is in a bifurcated configuration, the first tip and the second tip are spaced apart by a deployed distance measured from the first
  • EMBODIMENT 2 The device of embodiment 1, wherein when the needle assembly extends from the needle lumen and is in proximity to a target nerve and energized, the device is configured to ablate a length of the target nerve that is at least as long as or longer than the deployed distance between the first tip and the second tip.
  • EMBODIMENT 3 The device of embodiment 1 or 2, further comprising a needle tube extending within and/or from the needle lumen, wherein the needle assembly is at least partially disposed within the needle tube, wherein the needle assembly has a bifurcated configuration when at least partially extending from the needle tube.
  • EMBODIMENT 4 An embodiment comprising a device for treating a medical condition, the device comprising: a catheter having a longitudinal axis; a balloon having a proximal shoulder at a distal portion of the catheter, wherein the balloon is in fluid communication and configured to be inflated with an inflation medium; a needle tube disposed on an outer surface of the balloon, and a needle assembly configured to extend within and/or from the needle tube, the needle assembly comprising: a first needle having a first tip and a second needle having a second tip, wherein the first needle and the second needle are disposed at a needle assembly distal end, the needle assembly having A) a non-bifurcated configuration prior to extending a prescribed distance from the needle tube, and B) a bifurcated configuration when extending a prescribed distance from the needle tube, wherein when the needle assembly is in a bifurcated configuration, the first tip and the second tip are spaced apart by a deployed distance measured from the first tip and the second tip, wherein when the
  • the device of embodiment 4 wherein when the needle assembly extends the prescribed distance from the needle tube and is in proximity to a target nerve and energized, the device is configured to ablate a length of the target nerve that is at least as long as or longer than the deployed distance between the first tip and the second tip.
  • EMBODIMENT 5 The device of embodiment 4 or 5, wherein the balloon is in fluid communication with the inflatable medium via an inflation tube.
  • EMBODIMENT 6 The device of any one of embodiments 4-6, wherein the inflation medium comprises a gas or liquid.
  • EMBODIMENT 7 The device of embodiment 7, wherein the inflation medium comprise air, saline, or water.
  • EMBODIMENT 8 The device of any one of embodiments 1-8, wherein the first ablation electrode and the second ablation electrode are electrically isolated from each other.
  • EMBODIMENT 9 The device of any one of embodiments 1-9, wherein the needle assembly is configured to deliver an electric charge in a bipolar manner.
  • EMBODIMENT 10 The device of any one of embodiments 1-10, wherein the first ablation electrode and/or the second ablation electrode in operative communication with a controller to modulate a power delivered by the first and/or second source of energy.
  • EMBODIMENT 11 The device of embodiment 2 or 5, wherein the length of the target nerve that is ablated is 10% to 1000% longer than the deployed distance.
  • EMBODIMENT 12 The device of any one of embodiments 1-12, wherein the deployed distance is from about 1mm to about 10cm.
  • EMBODIMENT 13 The device of any one of embodiments 1-13, wherein the first needle and the second needle comprises a memory material, enabling the needle assembly to change into the bifurcated configuration when not constrained in the needle assembly lumen.
  • EMBODIMENT 14 The device of any one of embodiments 1-14, further comprising a neurostimulation electrode disposed on an outer surface catheter, the neurostimulation electrode in electrical communication with the first, second or a third source of energy at the proximal end of the device and configured to stimulate a target nerve.
  • EMBODIMENT 15 The device of embodiment 14, wherein the neurostimulation electrode is positioned within 0-90 degrees radially of a location on the outer surface of the catheter relative to the longitudinal axis of the catheter on an outer surface thereof.
  • EMBODIMENT 16 The device of embodiment 14, wherein two or more of the first and second, and third sources of energy are the same or different sources of energy.
  • EMBODIMENT 17 The device of embodiment 14, wherein two or more of the first, second, and third sources of energy have different energy parameters or the same energy parameters (such as driving frequency, current, and/or voltage amplitude, etc.).
  • EMBODIMENT 18 comprising a device for treating a medical condition, the device comprising: a catheter having a longitudinal axis; a balloon having a proximal shoulder at a distal portion of the catheter, wherein the balloon is in fluid communication and configured to be inflated with an inflation medium; a needle tube disposed on an outer surface of the balloon; a hollow needle having a needle longitudinal axis and configured to extend within and/or from the needle tube, the hollow needle in fluid communication with an ablation medium, the hollow needle having a lateral needle opening for delivering the ablation medium therefrom; and a neurostimulation electrode disposed on an outer surface of the catheter, the neurostimulation electrode in electrical communication with a first source of energy, and configured to stimulate a target nerve; wherein when the balloon is inflated, the needle tube moves to a non-zero angle relative to the longitudinal axis of the catheter, and wherein the device is configured to ablate a length of the target nerve via delivery of the ablation medium through the lateral
  • EMBODIMENT 19 The device of embodiment 19, wherein the balloon is in fluid communication with the inflatable medium via an inflation tube.
  • EMBODIMENT 20 The device of any one of embodiments 19 or 20, wherein the inflation medium comprises a gas or liquid.
  • EMBODIMENT 21 The device of embodiment 21, wherein the inflation medium comprise air, saline, or water.
  • EMBODIMENT 22 The device of any one of embodiments 19-22, wherein the ablation medium comprises a liquid and/or gas.
  • EMBODIMENT 23 The device of any one of embodiments 19-23, wherein the ablation medium comprises carbon dioxide, ethanol, liquid nitrogen, a conductive substance (e.g., saline, specialized hydrogel, etc.), an alcohol, lidocaine, lidocaine analogues, or a combination thereof.
  • a conductive substance e.g., saline, specialized hydrogel, etc.
  • EMBODIMENT 24 The device of any one of embodiments 19-24, wherein the neurostimulation electrode is positioned within 0-90 degrees radially of a location on the outer surface of the catheter relative to the longitudinal axis of the catheter on an outer surface thereof.
  • EMBODIMENT 25 The device of any one of embodiments 1-25, further comprising a neurosensory region configured to sense nerve activity of a target nerve.
  • EMBODIMENT 26 The device of embodiment 26, wherein the neurosensory region is configured to detect action potentials of the target nerve.
  • EMBODIMENT 27 The device of embodiment 26 or 27, wherein the neurosensory region comprises a neurosensory electrode.
  • EMBODIMENT 28 The device of any one of embodiments 1-28, wherein the catheter further comprises a radiopaque region.
  • EMBODIMENT 29 An embodiment comprising a method for treating a medical condition, the method comprising: inserting a catheter into a subject, the catheter having an opening at a distal portion thereof; guiding the catheter using an anatomic landmark to a first position within the subject so as to approximate a location of a target nerve; delivering a first stimulation to the target nerve via a neurostimulation electrode disposed on the catheter; and measuring a physiological response corresponding to the first stimulation, thereby confirming a location of the target nerve.
  • EMBODIMENT 30 The method of embodiment 30, further comprising, prior to step (d): (a) monitoring a physiological parameter; (b) moving the catheter to a second position within the subject, so as to approximate the location of the target nerve; and (c) delivering a second stimulation to the target nerve via the neurostimulation electrode.
  • EMBODIMENT 31 The method of embodiment 30 or 31, further comprising, prior to delivering the first stimulation, sensing a nerve activity of the target nerve using a neurosensory region disposed on the catheter.
  • EMBODIMENT 32 The method of any one of embodiments 30-32, further comprising: extending a needle assembly from the catheter to the target nerve; and ablating a length of the target nerve to provide a treatment for the medical condition.
  • EMBODIMENT 33 The method of embodiment 33, wherein the needle assembly comprises an ablation electrode.
  • EMBODIMENT 34 The method of embodiment 33, further comprising, prior to ablating the length of the target nerve, bifurcating the needle assembly to space apart a first needle tip on a first needle from a second needle tip on a second needle, wherein a first ablation electrode is disposed on the first needle, and a second ablation electrode is disposed on the second needle, and wherein the ablating is via the first ablation electrode and the second ablation electrode.
  • EMBODIMENT 35 The method of embodiment 35, wherein the length of the target nerve comprises is at least as long or longer than a distance between the first needle tip and the second needle tip after bifurcating the needle assembly.
  • EMBODIMENT 36 The method of embodiment 35 or 36, further comprising, prior to extending the needle assembly from the catheter, expanding a balloon disposed on the catheter so as to orient the needle assembly in a direction that aligns each ablation electrode with the target nerve.
  • EMBODIMENT 37 The method of any one of embodiments 35-37, wherein ablating the at least the portion of the target nerve comprises delivering radiofrequency energy, microwave energy, or both, to the target nerve.
  • EMBODIMENT 38 The method of embodiment 33, wherein the needle assembly comprises a hollow needle having a fluid port, wherein the hollow needle is in fluid communication with an ablation medium.
  • EMBODIMENT 39 The method of embodiment 39, wherein the ablating the length of the target nerve comprises delivering the ablation medium to the target nerve via the fluid port.
  • EMBODIMENT 40 The method of embodiment 40, wherein the ablation medium comprises carbon dioxide, ethanol, liquid nitrogen, a conductive substance (e.g., saline, specialized hydrogel, etc.), an alcohol, lidocaine, lidocaine analogues, or a combination thereof.
  • a conductive substance e.g., saline, specialized hydrogel, etc.
  • EMBODIMENT 41 The method of any one of embodiments 33-41, further comprising: delivering a third stimulation to the target nerve via the neurostimulation electrode; and confirming an interrupted nerve activity of the target nerve.
  • EMBODIMENT 42 The method of embodiment 42, wherein the confirming the interrupted nerve activity comprises detecting a lack or insignificant physiological change after delivering the third stimulation.
  • EMBODIMENT 43 The method of any one of embodiments 33-43, further comprising rotating the catheter so as to position the needle assembly, such that the needle assembly extends from the catheter to the target nerve.
  • EMBODIMENT 44 The method of any one of embodiments 30-44, wherein guiding the catheter comprises using fluoroscopy using a radiopaque region on the catheter.
  • EMBODIMENT 45 The method of any one of embodiments 30-45, wherein the anatomic landmark comprises the ninth thoracic vertebra (T9).

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Abstract

Des modes de réalisation décrits dans la description comprennent un système comprenant un cathéter définissant une lumière et un orifice de sortie et portant un premier ensemble d'électrodes et un second ensemble d'électrodes conçues pour délivrer de l'énergie de stimulation ou détecter un signal en réponse à l'énergie de stimulation. Le cathéter est conçu pour être inséré à travers une veine azygos et dans une veine intercostale bifurquant de la veine azygos de telle sorte que le premier ensemble d'électrodes est disposé à l'intérieur de la veine intercostale de manière adjacente à un nerf splanchnique du sujet et le second ensemble d'électrodes est disposé à l'intérieur de la veine azygos. Le système peut comprendre une sonde d'ablation conçue pour être disposée de manière coulissante à l'intérieur de la lumière et pouvant avancer à travers l'orifice de sortie du cathéter pour percer au moins une veine parmi la veine azygos ou la veine intercostale et ablater le nerf splanchnique.
PCT/US2025/033382 2024-06-12 2025-06-12 Systèmes et procédés d'interruption de l'activité nerveuse destinés à traiter un problème médical Pending WO2025259894A1 (fr)

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Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20190015002A1 (en) * 2013-10-25 2019-01-17 Ablative Solutions, Inc. Apparatus for effective ablation and nerve sensing associated with denervation
US20200179045A1 (en) * 2016-07-29 2020-06-11 Axon Therapies, Inc. Devices, systems, and methods for treatment of heart failure by splanchnic nerve ablation
US20240041518A1 (en) * 2022-06-15 2024-02-08 Corveus Medical, Inc. Systems and methods for interrupting nerve activity to treat a medical condition

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20190015002A1 (en) * 2013-10-25 2019-01-17 Ablative Solutions, Inc. Apparatus for effective ablation and nerve sensing associated with denervation
US20200179045A1 (en) * 2016-07-29 2020-06-11 Axon Therapies, Inc. Devices, systems, and methods for treatment of heart failure by splanchnic nerve ablation
US20240041518A1 (en) * 2022-06-15 2024-02-08 Corveus Medical, Inc. Systems and methods for interrupting nerve activity to treat a medical condition

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