WO2018226334A1 - Dispositif d'électrophysiologie à électrodes sélectives d'ions - Google Patents

Dispositif d'électrophysiologie à électrodes sélectives d'ions Download PDF

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Publication number
WO2018226334A1
WO2018226334A1 PCT/US2018/031052 US2018031052W WO2018226334A1 WO 2018226334 A1 WO2018226334 A1 WO 2018226334A1 US 2018031052 W US2018031052 W US 2018031052W WO 2018226334 A1 WO2018226334 A1 WO 2018226334A1
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WIPO (PCT)
Prior art keywords
ion
electrode
selective coating
selective
tissue
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Ceased
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PCT/US2018/031052
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English (en)
Inventor
Edward E. Parsonage
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St Jude Medical Cardiology Division Inc
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St Jude Medical Cardiology Division Inc
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Publication of WO2018226334A1 publication Critical patent/WO2018226334A1/fr
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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
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L29/00—Materials for catheters, medical tubing, cannulae, or endoscopes or for coating catheters
    • A61L29/08—Materials for coatings
    • A61L29/10—Inorganic materials
    • A61L29/106—Inorganic materials other than carbon
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B2017/00526—Methods of manufacturing
    • 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
    • A61B2018/00053—Mechanical features of the instrument of device
    • A61B2018/00107—Coatings on the energy applicator
    • 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
    • A61B2018/00053—Mechanical features of the instrument of device
    • A61B2018/00107—Coatings on the energy applicator
    • A61B2018/00125—Coatings on the energy applicator with nanostructure
    • 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
    • A61B2018/00351—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
    • A61B2018/00571—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
    • 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

Definitions

  • the instant disclosure relates to catheters for use in medical procedures, such as electrophysiology studies.
  • the instant disclosure relates to electrophysiology catheters that include ion-specific electrodes.
  • Catheters are used for an ever-growing number of procedures, such as diagnostic, therapeutic, and ablative procedures, to name just a few examples.
  • the catheter is manipulated through the patient's vasculature and to the intended site, for example, a site within the patient's heart.
  • a typical electrophysiology catheter includes an elongate shaft and one or more electrodes on the distal end of the shaft.
  • the electrodes may be used for ablation, diagnosis, or the like.
  • these electrodes include ring electrodes that extend about the entire circumference of the catheter shaft, as well as a tip electrode.
  • the measured voltage of a measurement electrode in contact with myocardium generally includes two components.
  • a first component is related to the local electric field generated by the membrane potential of the cardiomyocytes, versus a distant reference electrode.
  • a second component is an electrochemical potential related to the difference in local chemical/ion concentration between the measurement electrode and the reference electrode.
  • the second component e.g., electrochemical potential
  • Extant measurement electrodes such as those utilized in the diagnosis and treatment of atrial fibrillation, are typically made of relatively inert platinum iridium alloys and thus exhibit little chemical specificity. Instead, they measure primarily on the first component described above, which can result in susceptibility to far-field noise, e.g., from the left ventricle.
  • an electrophysiology catheter including: a body; and at least one electrode disposed on the body, wherein the at least one electrode includes an ion-selective coating.
  • the ion-selective coating can be applied uniformly over the at least one electrode or can cover only a portion of the at least one electrode.
  • the at least one electrode also includes a tissue-penetrating texture.
  • the tissue-penetrating texture can extend between about 0.1 ⁇ and about 20 ⁇ from a surface of the at least one electrode.
  • the ion-selective coating can include one or more of a bound form of an ionic chelating agent; a non-ionic compound with an ability to complex with a specific ion; a material that binds ions through specific surface interactions; and a material that binds ions through three- dimensional topology.
  • the ion-selective coating can include a crown ether, a zeolite, and/or ethylenediaminetetraacetic acid (EDTA).
  • the ion-selective coating is selective for one or more ions relative to cardiomyocyte membrane potentials, such as potassium, sodium, calcium, and/or chlorine.
  • the ion-selective coating can have a thickness between 0.005 ⁇ and 10 ⁇ .
  • Also disclosed herein is a method of manufacturing an electrophysiology catheter, including the steps of: forming a catheter body; forming at least one electrode on the catheter body; and coating the at least one electrode with an ion-selective coating.
  • the method optionally also includes forming a tissue-penetrating texture on a surface of the at least one electrode.
  • the tissue-penetrating texture can be formed by plating the tissue- penetrating texture onto the surface of the at least one electrode; by vacuum depositing the tissue-penetrating texture on the surface of the at least one electrode; and/or by laser sintering the tissue-penetrating texture into the surface of the at least one electrode.
  • the ion-selective coating is selective for one or more ions relative to cardiomyocyte membrane potentials, such as one or more of potassium, sodium, calcium, and chlorine.
  • the ion- selective coating can be selected from the group consisting of ethylenediaminetetraacetic acid (EDTA), crown ethers, and zeolites.
  • Figure 1 schematically depicts an electrophysiology catheter and associated systems.
  • Figure 2 is a close-up view of the distal region of the catheter shown in Figure 1.
  • Figure 3 is a transverse cross-section taken along line 3-3 in Figure 2.
  • Figure 4 depicts the application of an ion-specific coating to a flat electrode.
  • Figure 5 is a close-up view of an alternative embodiment of the distal region of the catheter shown in Figure 1.
  • Figures 6A-6C depict configurations of tissue penetrating textures and the application of ion-specific coatings thereto according to various aspects of the disclosure.
  • catheter 10 generally includes an elongate catheter body 12 having a distal region 14 and a proximal end 16.
  • a handle 18 is shown coupled to proximal end 16.
  • Figure 1 also shows connectors 20.
  • Connectors 20 are configured to be connected to a source of ablation energy (schematically illustrated as RF source 22, which can be, for example, the AmpereTM RF ablation generator of Abbott Laboratories), an electrophysiology mapping device (schematically illustrated as 24, which can be, for example, the EnSite PrecisionTM cardiac mapping system, also of Abbott Laboratories), and a programmable electrical stimulator (schematically illustrated as 25, which can be, for example the EP-4TM cardiac stimulator, also of Abbott Laboratories).
  • RF source 22 can be, for example, the AmpereTM RF ablation generator of Abbott Laboratories
  • an electrophysiology mapping device Schematically illustrated as 24, which can be, for example, the EnSite PrecisionTM cardiac mapping system, also of Abbott Laboratories
  • a programmable electrical stimulator Schematically illustrated as 25, which can be, for example the EP-4TM cardiac stimulator, also of Abbott Laboratories.
  • Figure 1 depicts three separate connectors 20, it is within the scope of the instant disclosure to have a combined connector 20 that is configured for
  • catheter 10 can be made steerable, for example by incorporating an actuator into handle 18 that is coupled to one or more steering wires that extend through elongate catheter body 12 and that terminate in one or more pull rings within distal region 14.
  • catheter 10 can be an irrigated catheter, such that it can also be coupled to a suitable supply of irrigation fluid and/or an irrigation pump.
  • catheter 10 can be equipped with force feedback capabilities.
  • catheter 10 can incorporate various aspects and features the following catheters, all from Abbott Laboratories: the EnSiteTM ArrayTM catheter; the Flex AbilityTM ablation catheter; the SafireTM BLUTM ablation catheter; the TherapyTM Cool PathTM irrigated ablation catheter; the LivewireTM TC ablation catheter; and the TactiCathTM Quartz irrigated ablation catheter.
  • Figure 2 is a close-up of distal region 14 of catheter 10.
  • Distal region 14 of catheter 10 includes a tip electrode 26 positioned at its distal end and a plurality of additional electrodes 28 proximal of tip electrode 26.
  • Figure 2 depicts five ring electrodes 28.
  • the person of ordinary skill in the art will understand and appreciate, however, that by varying the size (e.g., width) and spacing of electrodes 28, different diagnostic and/or therapeutic obj ectives and/or outcomes can be achieved.
  • distal region 14 can include any number of such electrodes 28 (e.g., 9 electrodes 28 for a decapolar catheter 10) and that the inter-electrode spacing can vary along the length of distal region 14.
  • Electrodes 28 may include any metal capable of detecting and conducting the local electrical signal. Suitable materials for electrodes 28 include, without limitation, platinum- iridium alloys and gold.
  • Electrodes 28 can also be of various physical configurations. These include, by way of example only, ring electrodes, segmented ring electrodes, partial ring electrodes, flexible circuit electrodes, balloon electrodes, and spot electrodes. Various configurations of electrodes 28 (as well as electrode 26) are disclosed in International Publication No. WO 2016/182876, which is hereby incorporated by reference as though fully set forth herein.
  • FIG. 3 is a transverse cross section of electrode 28, taken along line 3-3 in Figure 2, according to a first embodiment of the instant disclosure. As shown in Figure 3, electrode 28 includes an ion- selective coating 30.
  • Figure 4 depicts an ion-selective electrode 40 according to another aspect of the instant disclosure. More particularly, Figure 4 depicts a flat electrode 40, such as a flex circuit electrode, with an ion-selective coating 30 thereon.
  • ion-selective coating 30 can be between about 0.005 microns and about 10 microns in thickness.
  • Ion-selective coatings for electrodes will be familiar to those of skill in the art. See, e.g., Mikhelson, Ion Selective Electrodes (Springer- Verlag Berlin Heidelberg, 2013), which is hereby incorporated by reference as though fully set forth herein. Those of ordinary skill in the art will also be familiar with cardiac voltage map optical imaging using ion-sensitive electrodes.
  • Electrodes with ion-selective coatings can be used for the characterization of neural electrical activity. See, e.g., Haack et al., Double-barreled and Concentric Microelectrodes for Measurement of
  • ion-selective coating 30 can be sensitive to any combination of ions relative to cardiomyocyte membrane potentials, including, without limitation, potassium, sodium, calcium, and chlorine.
  • ions relative to cardiomyocyte membrane potentials
  • the local extracellular calcium concentration exhibits a relatively pronounced fractional change during the cardiac cycle ⁇ see, e.g., Hrabcova et al., Effect of Ion Concentration Changes in the Limited Extracellular Spaces on Sarcolemnal Ion Transport and Ca2+ Turnover in aModel of Human Ventricular Cardiomyocyte, Int. J. Mol. Sci. (2013), which is hereby incorporated by reference as though fully set forth herein), it is desirable for ion-selective coating 30 to be sensitive to calcium.
  • Ion-selective coating 30 can include any material that affects the electrode surface voltage through specific chemical interaction with the local ion milieu. Suitable materials for ion-selective coating 30 include, without limitation, bound forms of ionic chelating agents ⁇ e.g., ethylenediaminetetraacetic acid (EDTA)); non-ionic compounds with the ability to complex with specific ions ⁇ e.g., crown ethers); and materials that bind ions through specific surface interactions or three-dimensional topology ⁇ e.g., zeolites).
  • ionic chelating agents e.g., ethylenediaminetetraacetic acid (EDTA)
  • EDTA ethylenediaminetetraacetic acid
  • non-ionic compounds with the ability to complex with specific ions e.g., crown ethers
  • materials that bind ions through specific surface interactions or three-dimensional topology ⁇ e.g., zeolites.
  • FIG. 5 is a close-up of an alternative embodiment of the distal region of catheter 10, designated 14', that illustrates additional aspects of the instant disclosure.
  • Figure 5 shows an alternative tip electrode 26', an alternative ring electrode 28', and an alternative flat electrode 40' .
  • Each of tip electrode 26', ring electrode 28', and flat electrode 40' includes a tissue- penetrating texture 50. Tissue penetrating texture 50 allows electrodes 26', 28', and 40' to penetrate through the endothelium layer of the endocardium in order to facilitate the detection of ion variability.
  • tissue penetrating texture 50 extends between about 0.1 ⁇ and about 20 ⁇ from the surface of electrodes 26', 28', and 40'.
  • Tissue penetrating texture 50 can be formed, for example, by plating, by vacuum deposition, by laser sintering, or by any other suitable manufacturing method.
  • tissue penetrating texture 50 is depicted in Figure 5 as a sawtooth feature, other configurations, such as a series of plateaus (see, e.g., Figure 6C) are regarded as within the scope of the instant disclosure.
  • FIGs 6A through 6C depict various approaches to applying ion-selective coating 30 to tissue penetrating texture 50.
  • ion-selective coating 30 covers substantially all of tissue penetrating texture 50, as well as substantially the entire surface of the underlying electrode (e.g., electrode 26', 28', and/or 40').
  • Figure 6B depicts ion-selective coating 30 covering only a tip of a sawtooth-shaped tissue penetrating texture 50.
  • ion-selective coating 30 covers only a portion of the underlying electrode (e.g., electrode 26', 28', and/or 40').
  • Figure 6C similarly depicts ion-selective coating 30 covering only a portion of tissue penetrating texture 50, and therefore only a portion of the underlying electrode. More particularly, Figure 6C depicts an embodiment where ion-selective coating 30 covers the plateau of a plateau-shaped tissue penetrating texture.
  • electrodes with ion-selective coatings as disclosed herein advantageously offer improved sensitivity to the true localized action potential sequence, allowing for an increased reliance on the second component of voltage signals measured by intracardiac electrodes. This, in turn, results in less susceptibility to far-field noise when measuring intracardiac electrograms.
  • All directional references e.g., upper, lower, upward, downward, left, right, leftward, rightward, top, bottom, above, below, vertical, horizontal, clockwise, and
  • joinder references e.g., attached, coupled, connected, and the like are to be construed broadly and may include intermediate members between a connection of elements and relative movement between elements. As such, joinder references do not necessarily infer that two elements are directly connected and in fixed relation to each other.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Surgery (AREA)
  • Engineering & Computer Science (AREA)
  • Veterinary Medicine (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Otolaryngology (AREA)
  • Measurement And Recording Of Electrical Phenomena And Electrical Characteristics Of The Living Body (AREA)
  • Physics & Mathematics (AREA)
  • Epidemiology (AREA)
  • Plasma & Fusion (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Biomedical Technology (AREA)
  • Inorganic Chemistry (AREA)
  • Cardiology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Medical Informatics (AREA)
  • Molecular Biology (AREA)
  • Chemical & Material Sciences (AREA)
  • Surgical Instruments (AREA)

Abstract

L'invention concerne un cathéter d'électrophysiologie comprenant un corps et au moins une électrode disposée sur celui-ci. L'électrode comprend un revêtement sélectif d'ions, tel qu'un éther couronne, une zéolite, et/ou de l'acide éthylènediaminetétraacétique (EDTA), qui est sélectif d'un ou plusieurs ions par rapport aux potentiels de la membrane des cardiomyocytes, tels que le potassium, le sodium, le calcium et/ou le chlore. Le revêtement sélectif d'ions peut être appliqué uniformément sur les électrodes ou ne recouvrir qu'une partie des électrodes. Les électrodes peuvent également comprendre une texture de pénétration de tissu.
PCT/US2018/031052 2017-06-06 2018-05-04 Dispositif d'électrophysiologie à électrodes sélectives d'ions Ceased WO2018226334A1 (fr)

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US201762515778P 2017-06-06 2017-06-06
US62/515,778 2017-06-06

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Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1994010838A1 (fr) * 1992-11-12 1994-05-26 Board Of Regents, The University Of Texas System Preparations pharmaceutiques m-edta et leurs utilisations
WO1998058681A2 (fr) * 1997-06-20 1998-12-30 Ep Technologies, Inc. Enduits pour catheters et dispositifs a fins diagnostiques et therapeutiques par contact direct
WO2002018003A1 (fr) * 2000-08-30 2002-03-07 Biocoat Incorporated Revetements de hyaluronane bi-laminaires a proprietes anti-microbiennes dues a des ions argent
WO2007005910A2 (fr) * 2005-06-30 2007-01-11 Mc3, Inc. Revetements d'oxyde nitrique pour dispositifs medicaux
US20140172010A1 (en) * 2012-12-13 2014-06-19 Alcon Research, Ltd. Fine membrane forceps with integral scraping feature
WO2015138360A1 (fr) * 2014-03-09 2015-09-17 Neuro Tronik Ip Holding (Jersey) Limited Systèmes et procédés de neuromodulation de nerfs cardiaques sympathiques et parasympathiques
WO2016182876A1 (fr) 2015-05-11 2016-11-17 St. Jude Medical, Cardiology Division, Inc. Cathéter de cartographie et d'ablation haute densité

Patent Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1994010838A1 (fr) * 1992-11-12 1994-05-26 Board Of Regents, The University Of Texas System Preparations pharmaceutiques m-edta et leurs utilisations
WO1998058681A2 (fr) * 1997-06-20 1998-12-30 Ep Technologies, Inc. Enduits pour catheters et dispositifs a fins diagnostiques et therapeutiques par contact direct
WO2002018003A1 (fr) * 2000-08-30 2002-03-07 Biocoat Incorporated Revetements de hyaluronane bi-laminaires a proprietes anti-microbiennes dues a des ions argent
WO2007005910A2 (fr) * 2005-06-30 2007-01-11 Mc3, Inc. Revetements d'oxyde nitrique pour dispositifs medicaux
US20140172010A1 (en) * 2012-12-13 2014-06-19 Alcon Research, Ltd. Fine membrane forceps with integral scraping feature
WO2015138360A1 (fr) * 2014-03-09 2015-09-17 Neuro Tronik Ip Holding (Jersey) Limited Systèmes et procédés de neuromodulation de nerfs cardiaques sympathiques et parasympathiques
WO2016182876A1 (fr) 2015-05-11 2016-11-17 St. Jude Medical, Cardiology Division, Inc. Cathéter de cartographie et d'ablation haute densité

Non-Patent Citations (5)

* Cited by examiner, † Cited by third party
Title
HAACK ET AL.: "Double-barreled and Concentric Microelectrodes for Measurement of Extracellular Ion Signals in Brain Tissue", J. VISUALIZED EXPERIMENTS, 2015
HERRON ET AL.: "Optical Imaging of Voltage and Calcium in Cardiac Cells & Tissues", CIRCULATION RESEARCH, 2012
HRABCOVA ET AL.: "Effect of Ion Concentration Changes in the Limited Extracellular Spaces on Sarcolemnal Ion Transport and Ca2+ Turnover in aModel of Human Ventricular Cardiomyocyte", INT. J. MOL. SCI., 2013
KONOPKA ET AL.: "Factors Affecting the Potentiometric Response of All-Solid-State Solvent Polymeric Membrane Calcium-Selective Electrode for Low- Level Measurements", ANAL. CHEM., 2004
MIKHELSON: "Ion Selective Electrodes", 2013, SPRINGER-VERLAG

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