EP4601534A1 - Système d'imagerie - Google Patents

Système d'imagerie

Info

Publication number
EP4601534A1
EP4601534A1 EP23878031.6A EP23878031A EP4601534A1 EP 4601534 A1 EP4601534 A1 EP 4601534A1 EP 23878031 A EP23878031 A EP 23878031A EP 4601534 A1 EP4601534 A1 EP 4601534A1
Authority
EP
European Patent Office
Prior art keywords
assembly
optical
imaging
elongate shaft
shaft
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
EP23878031.6A
Other languages
German (de)
English (en)
Inventor
Christopher C. PETROFF
Andrea RIVAS
Christopher L. Petersen
Christopher Battles
Nareak Douk
Andrew BELLE-ISLE
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Gentuity LLC
Original Assignee
Gentuity LLC
Priority date (The priority date 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 date listed.)
Filing date
Publication date
Application filed by Gentuity LLC filed Critical Gentuity LLC
Publication of EP4601534A1 publication Critical patent/EP4601534A1/fr
Pending legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B1/00—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor
    • A61B1/00064—Constructional details of the endoscope body
    • A61B1/00071—Insertion part of the endoscope body
    • A61B1/0008—Insertion part of the endoscope body characterised by distal tip features
    • A61B1/00096—Optical elements
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B1/00—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor
    • A61B1/00131—Accessories for endoscopes
    • A61B1/00133—Drive units for endoscopic tools inserted through or with the endoscope
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B1/00—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor
    • A61B1/00147—Holding or positioning arrangements
    • A61B1/0016—Holding or positioning arrangements using motor drive units
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B1/00—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor
    • A61B1/00163—Optical arrangements
    • A61B1/00165—Optical arrangements with light-conductive means, e.g. fibre optics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B1/00—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor
    • A61B1/00163—Optical arrangements
    • A61B1/00172—Optical arrangements with means for scanning
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B1/00—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor
    • A61B1/00163—Optical arrangements
    • A61B1/00174—Optical arrangements characterised by the viewing angles
    • A61B1/00177—Optical arrangements characterised by the viewing angles for 90 degrees side-viewing
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B1/00—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor
    • A61B1/00163—Optical arrangements
    • A61B1/00194—Optical arrangements adapted for three-dimensional imaging
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B1/00—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor
    • A61B1/313—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor for introducing through surgical openings, e.g. laparoscopes
    • A61B1/3137—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor for introducing through surgical openings, e.g. laparoscopes for examination of the interior of blood vessels
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/0059—Measuring for diagnostic purposes; Identification of persons using light, e.g. diagnosis by transillumination, diascopy, fluorescence
    • A61B5/0062—Arrangements for scanning
    • A61B5/0066—Optical coherence imaging
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/02—Detecting, measuring or recording for evaluating the cardiovascular system, e.g. pulse, heart rate, blood pressure or blood flow
    • A61B5/021—Measuring pressure in heart or blood vessels
    • A61B5/0215—Measuring pressure in heart or blood vessels by means inserted into the body

Definitions

  • the motion can comprise relative axial motion.
  • the stabilizing assembly can be configured to release the optical connector when the connector assembly is attached to the probe interface unit.
  • the stabilizing assembly can be resiliently biased toward the optical connector to prevent motion when in a resting position.
  • the stabilizing assembly can be resiliently biased away from the optical assembly to allow motion when in a resting position.
  • the connector assembly can further comprise an outer shell configured to bias the stabilizing assembly towards the optical connector.
  • Fig. 6A-B illustrate an end view and a side view, respectively, of a portion of a reflector, consistent with the present inventive concepts.
  • Fig. 8 illustrates a partially transparent, perspective view of the distal portion of an imaging probe, consistent with the present inventive concepts.
  • Figs. 9A and 9B illustrate side sectional and top sectional views, respectively, of the distal end of an imaging probe, consistent with the present inventive concepts.
  • Figs. 10A and 10B illustrate optical modeling images and charts of results, consistent with the present inventive concepts.
  • Fig. 12 illustrates a side view of a portion of an imaging probe, consistent with the present inventive concepts.
  • Fig. 12A illustrates a side view of a portion of an imaging probe, consistent with the present inventive concepts.
  • first element when a first element is referred to as being “in”, “on” and/or “within” a second element, the first element can be positioned: within an internal space of the second element, within a portion of the second element (e.g. within a wall of the second element); positioned on an external and/or internal surface of the second element; and combinations of one or more of these.
  • threshold refers to a maximum level, a minimum level, and/or range of values correlating to a desired or undesired state.
  • a system parameter is maintained above a minimum threshold, below a maximum threshold, within a threshold range of values, and/or outside a threshold range of values, such as to cause a desired effect (e.g. efficacious therapy) and/or to prevent or otherwise reduce (hereinafter “prevent”) an undesired event (e.g. a device and/or clinical adverse event).
  • a system parameter is maintained above a first threshold (e.g.
  • a threshold value is determined to include a safety margin, such as to account for patient variability, system variability, tolerances, and the like.
  • “exceeding a threshold” relates to a parameter going above a maximum threshold, below a minimum threshold, within a range of threshold values and/or outside of a range of threshold values.
  • transducer where used herein is to be taken to include any component or combination of components that receives energy or any input, and produces an output.
  • a transducer can include an electrode that receives electrical energy, and distributes the electrical energy to tissue (e.g. based on the size of the electrode).
  • a transducer converts an electrical signal into any output, such as: light (e.g. a transducer comprising a light emitting diode or light bulb), sound (e.g. a transducer comprising a piezo crystal configured to deliver ultrasound energy); pressure (e.g. an applied pressure or force); heat energy; cryogenic energy; chemical energy; mechanical energy (e.g.
  • a transducer comprising a tissue manipulating element
  • sound energy to tissue e.g. a transducer comprising a piezo crystal
  • chemical energy e.g. a transducer comprising a piezo crystal
  • electromagnetic energy e.g. a transducer comprising a piezo crystal
  • magnetic energy e.g. a magnetic energy
  • the term “fluid” can refer to a liquid, gas, gel, or any flowable material, such as a material which can be propelled through a lumen and/or opening.
  • the systems of the present inventive concepts comprise an imaging probe and an imaging assembly.
  • the imaging probe can comprise an elongate shaft, a rotatable optical core, and an optical assembly.
  • the shaft can comprise a proximal end, a distal portion, and a lumen extending between the proximal end and the distal portion.
  • the rotatable optical core can comprise a proximal end and a distal end, and at least a portion of the rotatable optical core can be positioned within the lumen of the elongate shaft.
  • the optical assembly can be positioned proximate the distal end of the rotatable optical core and can be configured to direct light to tissue and collect reflected light from the tissue.
  • the imaging systems can comprise one or more algorithms configured to enhance the performance of the system.
  • System 10 can comprise console 300 that operably attaches to imaging probe 100, such as via PIU 200.
  • Imaging probe 100 can be introduced into a conduit of the patient, such as a blood vessel or other conduit of the patient, using (e.g. passing through) one or more delivery catheters, delivery catheter 80 shown. Additionally or alternatively, imaging probe 100 can be introduced through an introducer device, such as an endoscope, arthroscope, balloon dilator, or the like.
  • imaging probe 100 is configured to be introduced into a patient conduit and/or other patient internal site selected from the group consisting of: an artery; a vein; an artery within or proximate the heart; a vein within or proximate the heart; an artery within or proximate the brain; a vein within or proximate the brain; a peripheral artery; a peripheral vein; a patient internal site that is accessed through a natural body orifice, such as the esophagus; a patient internal site that is accessed through a surgically created orifice, such as a conduit or other site within the abdomen; and combinations of one or more of these.
  • imaging probe 100 and/or another component of system 10 can be of similar construction and arrangement to the similar components described in applicants co-pending United States Patent Application Serial Number 17/668,757 (Docket No. GTY-001-US-CON1), titled “Micro-Optic Probes for Neurology”, filed February 10, 2022.
  • Imaging probe 100 can be constructed and arranged to collect image data from a patient site, such as an intravascular cardiac site, an intracranial site, or other site accessible via the vasculature of the patient.
  • system 10 can be of similar construction and arrangement to the similar systems and their methods of use described in applicants co-pending United States Patent Application Serial Number 18/096,678 (Docket No. GTY-002-US-CON3), titled “Imaging System Includes Imaging Probe and Delivery Devices”, filed January 13, 2023.
  • Shaft 120 further comprises a distal portion 1208, including a transparent portion, window 130 (e.g. a window that is relatively transparent to the one or more frequencies of light transmitted through optical core 110).
  • An optical assembly, optical assembly 115 is operably attached to the distal end 1109 of optical core 110.
  • Optical assembly 115 is positioned within window 130 of shaft 120.
  • Optical assembly 115 can comprise a GRIN lens optically coupled to the distal end 1109 of optical core 110.
  • Optical assembly 115 can comprise a construction and arrangement similar to optical assembly 115 as described in applicant’s co-pending United States Patent Application Serial Number 18/144,462 (Docket No.
  • optical core 110 comprises a single continuous length of optical fiber comprising zero splices along its length.
  • imaging probe 100 comprises a single optical splice, such as a splice being between optical assembly 115 and distal end 1109 of optical core 110 (e.g. when there are zero splices along the length of optical core 110).
  • a connector assembly, connector assembly 150 is positioned on the proximal end of shaft 120.
  • Connector assembly 150 operably attaches imaging probe 100 to rotation assembly 210.
  • connector assembly 150 comprises an optical connector fixedly attached to the proximal end of optical core 110.
  • Imaging probe 100 can comprise a second connector, connector 180, that can be positioned on shaft 120.
  • Connector 180 can be removably attached and/or adjustably positioned along the length of shaft 120.
  • Connector 180 can be positioned along shaft 120, such as by a clinician, technician, and/or other user of system 10 (“user” or “operator” herein), proximate the proximal end of delivery catheter 80 after imaging probe 100 has been inserted into a patient via delivery catheter 80.
  • Shaft 120 can comprise a portion between connector assembly 150 and the placement location of connector 180 that is configured to provide and/or accommodate slack in shaft 120, service loop 185.
  • shaft 120 comprises a multi-part construction, such as an assembly of two or more tubes that can be connected in various ways.
  • one or more tubes of shaft 120 can comprise tubes made of polyethylene terephthalate (PET), such as when a PET tube surrounds the junction between two tubes (e.g. two portions of shaft 120) in an axial arrangement to create a joint between the two tubes.
  • PET polyethylene terephthalate
  • one or more PET tubes are under tension after assembly (e.g. the tubes are longitudinally stretched when shaft 120 is assembled), such as to prevent or at least reduce the tendency of the PET tube to wrinkle while shaft 120 is advanced through a tortuous path.
  • Imaging probe 100 can comprise one or more visualizable markers along its length (e.g. along shaft 120), marker 131 shown.
  • Marker 131 can comprise one or more markers selected from the group consisting of: radiopaque markers; ultrasonically reflective markers; magnetic markers; ferrous material; and combinations of one or more of these.
  • marker 131 is positioned at a location along imaging probe 100 selected to assist an operator of system 10 in performing a pullback procedure (“pullback procedure” or “pullback” herein).
  • marker 131 can be positioned approximately one pullback length from distal end 1209 of shaft 120, such that following a pullback, distal end 1209 will be no more proximal than the starting position of marker 131.
  • the operator can position marker 131 at a location distal to the proximal end of an implant, such that after the pullback is completed access into the implant is maintained (e.g. such that imaging probe 100 can be safely advanced through the implant after the pullback).
  • imaging probe 100 includes a viscous dampening material
  • gel 118 can be positioned within shaft 120 surrounding a distal portion of optical core 110 (e.g. a gel injected or otherwise installed in a manufacturing process).
  • gel 118 surrounds a portion of optical assembly 115.
  • gel 118 does not surround a portion of optical assembly 115, for example when optical assembly 115 is configured to operate in air, such as is described hereinbelow in reference to Figs. 2 and 3.
  • Gel 118 can comprise a non-Newtonian fluid, for example a shear-thinning fluid.
  • gel 118 comprises a static viscosity of at least 500 centipoise, and a shear viscosity that is less than the static viscosity. In these embodiments, the ratio of static viscosity to shear viscosity of gel 118 can be between 1.2: 1 and 100: 1. In some embodiments, gel 118 is injected from the distal end of window 130 (e.g. in a manufacturing process). In some embodiments, gel 118 comprises a gel which is visualizable (e.g. visualizable under UV light, such as when gel 118 includes one or more materials that fluoresce under UV light).
  • Gel 118 can comprise a gel as described in reference to applicants co-pending United States Patent Application Serial Number 17/668,757 (Docket No. GTY-001-US-CON1), titled “Micro-Optic Probes for Neurology”, filed February 10, 2022, and applicant’s co-pending United States Patent Application Serial Number 18/144,462 (Docket No. GTY-003-US- CON1), titled “Imaging System”, filed May 8, 2023.
  • Imaging probe 100 can include a distal tip portion, distal tip 119.
  • distal tip 119 can comprise a spring tip, such as a spring tip configured to improve the “navigability” of imaging probe 100 (e.g. to improve “trackability” and/or “steerability” of imaging probe 100), for example when probe 100 is translated within a tortuous pathway (e.g. within a blood vessel of the brain or heart with a tortuous pathway).
  • distal tip 119 comprises a length of between 5mm and 100mm (e.g. a spring with a length between 5mm and 100mm).
  • distal tip 119 can comprise a user shapeable spring tip (e.g.
  • distal tip 119 is malleable). Imaging probe 100 can be rotated (e.g. via connector 180) to adjust the direction of a nonlinear shaped portion of distal tip 119 (e.g. to adjust the trajectory of distal tip 119 in the vasculature of the patient).
  • distal tip 119 can comprise a cap, plug, and/or other element configured to seal the distal opening of window 130.
  • distal tip 119 can comprise a radiopaque marker configured to increase the visibility of imaging probe 100 under a fluoroscope or other X-ray device.
  • distal tip 119 can comprise a relatively short luminal guidewire pathway to allow “rapid exchange” translation of imaging probe 100 over a guidewire of system 10 (guidewire not shown).
  • At least the distal portion of imaging probe 100 (e.g. the distal portion of shaft 120 surrounding optical assembly 115) comprises an outer diameter of no more than 0.030”, such as no more than 0.025”, no more than 0.020”, and/or no more than 0.016”.
  • imaging probe 100 can be constructed and arranged for use in an intravascular neural procedure (e.g. a procedure in which the blood, vasculature, and/or other tissue proximate the brain are visualized, and/or devices positioned temporarily or permanently proximate the brain are visualized).
  • An imaging probe 100 configured for use in an intravascular neural procedure can comprise an overall length of at least 150 cm, such as a length of approximately 300cm.
  • imaging probe 100 can be constructed and arranged for use in an intravascular cardiac procedure (e.g.
  • An imaging probe 100 configured for use in an intravascular cardiac procedure can comprise an overall length of at least 120cm, such as an overall length of approximately 280cm (e.g. to allow placement of the proximal end of imaging probe 100 outside of the sterile field). In some embodiments, such as for placement of the proximal end of probe 100 outside of the sterile field, imaging probe 100 can comprise a length greater than 220 cm, such as a length of at least 220cm but less than 320cm.
  • imaging probe 100 comprises an element, FPE 1500 shown, which can be configured as a fluid propulsion element and/or a fluid pressurization element (“fluid pressurization element” herein).
  • FPE 1500 can be configured to prevent and/or reduce the presence of bubbles within gel 118 proximate optical assembly 115.
  • FPE 1500 can be fixedly attached to optical core 110, wherein rotation of optical core 110 in turn rotates FPE 1500, such as to generate a pressure increase within gel 118 that is configured to reduce presences of bubbles from locations proximate optical assembly 115.
  • delivery catheter 80 comprises an elongate shaft, shaft 81 shown, which includes a lumen 84 therethrough and a connector 82 positioned on its proximal end.
  • Connector 82 can comprise a Touhy or other valved connector, such as a valved connector configured to prevent fluid egress from the associated delivery catheter 80 (with and/or without a separate shaft positioned within the connector 82).
  • Connector 82 can comprise port 83, such as one or more ports constructed and arranged to allow introduction of fluid into delivery catheter 80 and/or for removing fluids from delivery catheter 80.
  • the third delivery catheter OD is less than or equal to the second delivery catheter ID), and so on.
  • the first delivery catheter 80 e.g. its distal end
  • the second delivery catheter 80 e.g. its distal end
  • delivery catheter 80 can be of similar construction and arrangement to the similar components described in applicants co-pending United States Patent Application Serial Number 18/096,678 (Docket No. GTY-002-US- CON3), titled “Imaging System Includes Imaging Probe and Delivery Devices”, filed January 13, 2023.
  • System 10 can further comprise one or more fluid injectors, injector 20 shown, each of which can be configured to inject one or more fluids, such as a flushing fluid, an imaging contrast agent (e.g. a radiopaque contrast agent, hereinafter “contrast”) and/or other fluid, such as injectate 21 shown.
  • injector 20 can comprise a power injector, syringe pump, peristaltic pump or other fluid delivery device configured to inject a contrast agent, such as radiopaque contrast, and/or other fluids.
  • injector 20 is configured to deliver contrast and/or other fluid (e.g. contrast, saline, and/or dextran).
  • injector 20 is configured to deliver two dissimilar fluids simultaneously and/or sequentially, such as a first fluid delivered from a first reservoir and comprising a first concentration of contrast, and a second fluid from a second reservoir and comprising less or no contrast.
  • Injectate 21 can comprise fluid selected from the group consisting of: optically transparent material; saline; visualizable material; contrast; dextran; an ultrasonically reflective material; a magnetic material; and combinations thereof. Injectate 21 can comprise contrast and saline. Injectate 21 can comprise at least 20% contrast.
  • a flushing procedure can be performed, such as by delivering one or more fluids, (e.g. injectate 21 as propelled by injector 20 or other fluid delivery device), to remove blood or other somewhat opaque material (hereinafter nontransparent material) proximate optical assembly 115 (e.g.
  • inj ectate 21 can comprise an optically transparent material, such as saline. Inj ectate 21 can comprise one or more visualizable materials, as described herein.
  • Implant delivery device 30 can comprise a catheter and/or other tool used to deliver implant 31, such as when implant 31 comprises a self-expanding or balloon expandable portion.
  • system 10 comprises imaging probe 100, one or more implants 31 and/or one or more implant delivery devices 30.
  • imaging probe 100 is configured to collect data related to implant 31 and/or implant delivery device 30 (e.g. implant 31 and/or implant delivery device 30 anatomical location, orientation and/or other configuration data), after implant 31 and/or implant delivery device 30 has been inserted into the patient.
  • one or more system 10 components such as second imaging device 15, treatment device 16, patient monitor 17, injector 20, implant delivery device 30, delivery catheter 80, imaging probe 100, PIU 200, rotation assembly 210, retraction assembly 220, and/or console 300, further comprise one or more functional elements (“functional element” herein), such as functional elements 99a, 99b, 99c, 99d, 99e, 89, 199, 299, 219, 229, and/or 399, respectively, each as shown.
  • Each functional element can comprise at least two functional elements.
  • Each functional element can comprise one or more elements selected from the group consisting of: sensor; transducer; and combinations thereof.
  • the functional element can comprise a sensor configured to produce a signal.
  • the sensor can comprise a position sensor configured to produce a signal related to a vessel path geometry (e.g. a 2D or 3D vessel path geometry).
  • the sensor can comprise a magnetic sensor.
  • the sensor can comprise a flow sensor.
  • the system can further comprise an algorithm configured to process the signal produced by the sensor-based functional element.
  • Each functional element can comprise one or more transducers.
  • Each functional element can comprise one or more transducers selected from the group consisting of: a heating element such as a heating element configured to deliver sufficient heat to ablate tissue; a cooling element such as a cooling element configured to deliver cryogenic energy to ablate tissue; a sound transducer such as an ultrasound transducer; a vibrational transducer; and combinations thereof.
  • imaging probe 100 comprises an overall length of at least 120cm, such as at least 160cm, such as approximately 280cm. In some embodiments, imaging probe 100 comprises an overall length of no more than 350cm. In some embodiments, imaging probe 100 comprises a length configured to be inserted into the patient (“insertable length” herein) of at least 90cm, such as at least 100cm, such as approximately 145cm. In some embodiments, imaging probe 100 comprises an insertable length of no more than 250cm, such as no more than 200cm. In some embodiments, distal tip 119 comprises a spring tip with a length of at least 5mm, such as at least 25 mm, such as approximately 15mm.
  • distal tip 119 comprises a spring tip with a length of no more than 75mm, such as no more than 30mm.
  • a distal portion of shaft 120 (e.g. window 130) comprises an outer diameter of less than 2Fr, such as less than 1.4Fr, such as approximately l. lFr.
  • a distal portion of shaft 120 (e.g. window 130) comprises an outer diameter of at least 0.5Fr, such as at least 0.9Fr.
  • shaft 120 comprises one or more materials selected from the group consisting of: polyether ether ketone (PEEK); nylon; polyether block amide; nickel -titanium alloy; and combinations of these.
  • PEEK polyether ether ketone
  • optical core 110 comprises an optical fiber with a diameter of less than 120pm, such as less than 100pm, such as less than 80pm, such as less than 60pm, such as approximately 40pm.
  • optical core 110 comprises a numerical aperture of one or more of 0.11, 0.14, 0.16, 0.17, 0.18, 0.20, and/or 0.25.
  • optical assembly 115 comprises a lens selected from the group consisting of: a GRIN lens; a molded lens; a shaped lens, such as a melted and polished lens; a lens comprising an axicon structure, (e.g. an axicon nanostructure); and combinations of these.
  • optical assembly 115 comprises a lens with an outer diameter of less than 200pm, such as less than 170pm, such as less than 150pm, such as less than 100pm, such as approximately 80pm.
  • optical assembly 115 comprises a lens with a length of less than 3mm, such as less than 1.5mm.
  • optical assembly 115 comprises a lens with a length of at least 0.5mm, such as at least 1mm.
  • optical assembly 115 comprises a lens with a focal length of at least 0.5mm and/or no more than 5.0mm, such as at least 1.0mm and/or no more than 3.0mm, such as a focal length of approximately 0.5mm.
  • optical assembly 115 can comprise longer focal lengths, such as to view structures outside of the blood vessel in which optical assembly 115 is inserted.
  • optical assembly 115 has a working distance (also termed depth of field, confocal distance, or Rayleigh Range) of up to 1mm, such as up to 5mm, such as up to 10 mm, such as a working distance of at least 1mm and/or no more than 5mm.
  • optical assembly 115 comprises an outer diameter of at least 80pm and/or no more than 200pm, such as at least 150pm and/or no more than 170pm, such as an outer diameter of approximately 150pm.
  • system 10 e.g. retraction assembly 220
  • system 10 e.g.
  • system 10 is configured to perform a pullback for a distance of at least 25mm and/or no more than 200mm, such as at least 25mm and/or no more than 150mm, such as a distance of approximately 50mm.
  • system 10 e.g. retraction assembly 220
  • system 10 is configured to perform a pullback over a time period of at least 0.2 seconds and/or no more than 5.0 seconds, such as at least 0.5 seconds and/or no more than 2.0 seconds, such as a time period of approximately 1.0 second.
  • system 10 e.g.
  • rotation assembly 210) is configured to rotate optical core 110 at an angular velocity of at least 20 rotations per second and/or no more than 1000 rotations per second, such as at least 100 rotations per second and/or no more than 500 rotations per second, such as an angular velocity of approximately 250 rotations per second.
  • delivery catheter 80 comprises an inner diameter of at least 0.016” and/or no more than 0.050”, such as at least 0.016” and/or no more than 0.027”, such as an inner diameter of approximately 0.021”.
  • console 300 comprises imaging assembly 320 that can be configured to provide light to optical assembly 115 (e.g. via optical core 110) and collect light from optical assembly 115 (e.g. via optical core 110).
  • Imaging assembly 320 can include a light source 325.
  • Light source 325 can comprise one or more light sources, such as one or more light sources configured to provide one or more wavelengths of light to optical assembly 115 via optical core 110.
  • Light source 325 is configured to provide light to optical assembly 115 (via optical core 110) such that image data can be collected comprising cross- sectional, longitudinal and/or volumetric information related to a patient site or implanted device being imaged.
  • light source 325 comprises a sweep rate of at least lOOKHz, such as at least 200Khz, 300KHz, 400KHz, and/or 500KHz, for example approximately 200kHz.
  • lOOKHz such as at least 200Khz, 300KHz, 400KHz, and/or 500KHz, for example approximately 200kHz.
  • the higher sweep rate enables the requisite sampling density (e.g. the amount of luminal surface area swept by the rotating beam) to be achieved in a shorter time, advantageous in most situations and especially advantageous when there is relative motion between the probe and the surface/tissue being imaged such as arteries in a beating heart.
  • Light source 325 bandwidth can be selected to achieve a desired resolution, which can vary according to the needs of the intended use of system 10. In some embodiments, bandwidths are about 5% to 15% of the center wavelength, which allows resolutions of between 20pm and 5pm.
  • Light source 325 can be configured to deliver light at a power level meeting ANSI Class 1 (“eye safe”) limits, though higher power levels can be employed. In some embodiments, light source 325 delivers light in the 1.3 pm band at a power level of approximately 20mW. Tissue light scattering is reduced as the center wavelength of delivered light increases, however water absorption increases. Light source 325 can deliver light at a wavelength approximating 1300nm to balance these two effects. Light source 325 can be configured to deliver shorter wavelength light (e.g.
  • the detector arrangement must be able to select very narrow linewidths from the spectrum of the source.
  • the coherence length scales inversely with the linewidth. Longer scan ranges enable larger or more distant objects to be imaged (e.g. more distal tissue to be imaged). Current systems have lower coherence length, which correlates to reduced image capture range as well as artifacts (ghosts) that arise from objects outside the effective scan range.
  • light source 325 comprises a sweep bandwidth of at least 30nm and/or no more than 250nm, such as at least 50nm and/or no more than 150nm, such as a sweep bandwidth of approximately lOOnm.
  • light source 325 comprises a center wavelength of at least 800nm and/or no more than 1800nm, such as at least 1200nm and/or no more than 1350nm, such as a center wavelength of approximately 1300nm.
  • light source 325 comprises an optical power of at least 5mW and/or no more than 500mW, such as at least lOmW and/or no more than 50mW, such as an optical power of approximately 20mW.
  • System 10 can comprise one or more operably-connecting cables or other conduits, bus 58 shown.
  • Bus 58 can operably connect PIU200 to console 300, rotation assembly 210 to console 300 (as shown), retraction assembly 220 to console 300, and/or rotation assembly 210 to retraction assembly 220.
  • Bus 58 can comprise one or more optical transmission fibers, wires, traces, and/or other electrical transmission cables, fluid conduits, and combinations of one or more of these.
  • bus 58 comprises at least an optical transmission fiber that optically couples rotation assembly 210 to imaging assembly 320 of console 300.
  • bus 58 comprises at least power and/or data transmission cables that transfer power and/or drive signals to one or more of motive elements of rotation assembly 210 and/or retraction assembly 220.
  • User interface 350 can include one, two, or more user input and/or user output components.
  • user interface 350 can comprise a joystick, keyboard, mouse, touchscreen, and/or another human interface device, user input device 351 shown.
  • user interface 350 comprises a display (e.g. a touchscreen display), such as display 352, also shown.
  • processor 312 can provide a graphical user interface, GUI 353, to be presented on and/or provided by display 352.
  • User interface 350 can include an input and/or output device selected from the group consisting of: a speaker; an indicator light, such as an LED indicator; a haptic feedback device; a foot pedal; a switch such as a momentary switch; a microphone; a camera, for example when processor 312 enables eye tracking and/or other input via image processing; and combinations of these.
  • an input and/or output device selected from the group consisting of: a speaker; an indicator light, such as an LED indicator; a haptic feedback device; a foot pedal; a switch such as a momentary switch; a microphone; a camera, for example when processor 312 enables eye tracking and/or other input via image processing; and combinations of these.
  • the one or more functions of system 10 performed by processing unit 310 and/or 410 can be performed by either or both processing units.
  • image data is collected and preprocessed by processing unit 310 of console 300.
  • the preprocessed image data can then be transferred to server 400, where the image data is further processed.
  • the processed image data can then be transferred back to console 300 to be displayed to the operator (e.g. via GUI 353).
  • a first set of one or more images (“image” herein) that is based on a first set of image data e.g. an image processed locally via processing unit 310) is displayed to the operator following the collection of the image data (e.g. in near-real-time), and a second image based on the first set of image data (e.g. an image processed remotely via processing unit 410) is displayed to the operator subsequently (e.g. when the first image was displayed while the second image was processed).
  • System 10 can reference the output of the metronome, such as at the time that radiopaque flushing material is injected to clear the blood from the target area to be imaged, since the one or more portions of imaging probe 100 (e.g. one or more marker bands) can become radioinvisible during this flushing period (e.g. radiopaque portions of probe 100 cannot be differentiated from the flushing material).
  • a non-radiopaque flushing material can be used (e.g. dextran).
  • flushing is started, such as by an operator or in an automated way controlled by system 10.
  • the flushing continues over several heart cycles, such as 3-5 heart cycles.
  • clearing of the vessel to be imaged is detected by system 10 analyzing one or more of the images produced by system 10.
  • a pullback starts at the low motion part of the metronome (e.g. a predicted low motion portion of the heart cycle), and accounting for the latency between system 10 components and the angiographic system previously established.
  • the pullback will finish in about one-half of a heart cycle or less, such as to cause capture of all or a portion of image data to remain within the low motion portion of the heart cycle.
  • System 10 can be configured to provide a pullback speed of at least 50 mm/sec, such as at least 100 mm/sec, or 200 mm/sec.
  • the pullback sequence of images which include minimal motion artifact, can be provided to the operator and/or used for: CFD calculations (described herein), implant (e.g. stent) length measurements, and the like.
  • CFD calculations described herein
  • implant e.g. stent
  • algorithm 315/415 comprises various signal and/or image processing algorithms configured to process and/or analyze image data collected by system 10.
  • system 10 can be configured to perform an automated quantification of one or more parameters, such as one or more patient parameters (e.g. parameters relating to the health of the patient), one or more image parameters (e.g. parameters relating to the quality of the image data), one or more treatment parameters (e.g. parameters relating to the clinical efficacy and/or technical proficiency of a treatment performed), and combinations of these.
  • system 10 can comprise a metric (e.g. a variable), data metric 525 shown, which can comprise a calculated result that is calculated using, and/or otherwise based on an analysis (e.g. a mathematical analysis) of these various parameters.
  • data metric 525 comprises a quantification of one or more characteristics (e.g. level of apposition or amount of protrusion) describing the interaction between the patient’s anatomy and a treatment device (e.g. implant 31) that has been implanted in the patient.
  • system 10 can be configured to analyze image data collected prior to, during, and/or after implantation of an implant, and to determine one or more values of data metric 525 that represent (e.g. correspond to) the interaction between the implant and patient tissue (e.g. the vessel wall, the ostium of one or more side-branches, and/or the neck of one or more aneurysms).
  • data metric 525 comprises a metric relating to the healing proximate an implantation site, for example when system 10 is used to collect image data from an implantation site in a follow-up procedure, such as a procedure performed at least one month, at least six months, or at least one year from the implant procedure.
  • data metric 525 comprises a metric relating to a predicted outcome of an interventional procedure, such as a metric whose value is calculated and/or updated during the interventional procedure, after the interventional procedure, or both.
  • data metric 525 can be used to provide guidance to the operator by indicating the predicted outcomes of intended (e.g. future) and/or already performed interventions (e.g.
  • the mesh density of a flow diverter covering the neck of an aneurysm can be estimated by system 10 (e.g. based on automated image processing described herein).
  • the mesh density can be used to predict the outcome of the intervention (e.g. long-term dissolution of the aneurysm).
  • the geometry of the mesh can be used to estimate the angle of optical assembly 115 relative to the surface of the mesh, and to correct the mesh density accordingly. For example, in a bend, the light exiting optical assembly 115 (e.g.
  • data metric 525 comprises a metric that informs (e.g. its value is used to recommend or otherwise inform) the patient’s clinician to potentially perform an additional (e.g. second) therapeutic procedure on the patient, such as to optimize or at least improve the therapeutic treatment in which at least a first procedure (e.g. an interventional procedure) has already been performed.
  • the additional therapeutic procedure can comprise an interventional procedure selected from the group consisting of: an adjustment to a device (e.g. treatment device 16) implanted in the patient in a previous procedure, such as an adjustment comprising a repositioning, expansion, contraction, and/or other adjustment to the implant; implantation of a device (e.g.
  • system 10 is configured to quantify the quality of image data, such as a quantification determined by an automated process of system 10, such as is described herein.
  • one or more analytic processes of system 10 e.g. image analysis described herein
  • system 10 can be configured to disable subsequent CFD or other calculations described herein based on that poor image data.
  • system 10 can assess the quality of a purge procedure based on the quality of the image data. For example, system 10 can assess image quality to identify blood ingress into delivery catheter 80, and indicate the need to purge. This analysis can be used for providing feedback to the user in real-time during imaging, such as by displaying a warning message (e.g. “purge catheter”). Similarly, after an image acquisition is completed, system 10 can analyze the image data and display a warning to the user if catheter purge was incomplete. In some embodiments, system 10 can analyze image data to identify blood residuals in the lumen, and to display a warning to the user as well as indicate to the user areas where blood clearance is incomplete. If blood clearance is incomplete in the region of high interest for CFD calculation (such as obscuring frame of reference or a stenosis), a warning can be provided about insufficient image quality for a CFD calculation.
  • system 10 is configured to perform various computational fluid dynamics (CFD) and/or optical flow ratio (OFR) calculations using high-resolution image data (e.g. OCT image data) to accurately simulate blood flow in a stenosed artery (e.g. a coronary artery), and to estimate pressure drops through one or more lesions, such as is described herein.
  • CFD computational fluid dynamics
  • OFR optical flow ratio
  • System 10 can be configured to enable capture (e.g. in a single “pullback acquisition”) of both vessel anatomy and physiology.
  • This combined solution has the key advantage of providing intrinsically co-registered anatomy and physiology data (e.g. data captured with a single device), that can be used to better plan and optimize coronary interventions than any of these tools alone.
  • CFD simulations performed by system 10 are designed to closely simulate hyperemic conditions, for example as it is done for the acquisition of fractional flow reserve data using a pressure wire.
  • CFD methods can be used to simulate non-hyperemic conditions, for example similar to the way iFR or RFR catheters are used to collect vessel hemodynamic data.
  • FFR devices typically make a single FFR measurement from a single location distal to all lesions.
  • System 10 can be configured to achieve a CFD simulation and pressure drop evaluation of a whole arterial segment (e.g. 100 mm or more) in a few seconds (e.g. less than 20 sec) using a simplified quasi-2D and/or 2D solver. If compared to a “full” 3D solver (e.g. a solver configured to implement Navier Stokes equations), a quasi-2D and/or 2D solver allows for an order of magnitude or more reduced computational time, retaining sufficient accuracy for coronary pressure drop evaluation.
  • a full arterial segment e.g. 100 mm or more
  • a quasi-2D and/or 2D solver e.g. a solver configured to implement Navier Stokes equations
  • CFD simulations heavily rely on the segmentation of image data (e.g. OCT image data). Segmentation can be obtained through traditional image processing algorithms and/or Al methodologies (e.g. machine learning, deep learning, neural network, and/or other artificial intelligence methodologies). In some embodiments, these methodologies include the various steps of Method 1000, described in reference to Fig. 5 herein, to analyze image data sets (e.g. OCT image data sets) to quantify blood flow and/or pressure drops.
  • image data e.g. OCT image data
  • Al methodologies e.g. machine learning, deep learning, neural network, and/or other artificial intelligence methodologies.
  • these methodologies include the various steps of Method 1000, described in reference to Fig. 5 herein, to analyze image data sets (e.g. OCT image data sets) to quantify blood flow and/or pressure drops.
  • system 10 comprises a graphical user interface, such as GUI 353 described herein, for example in reference to Figs. 3A-C.
  • GUI is configured to provide the user with an easy and immediate way to obtain and use OCT images and/or simulated physiology data to diagnose coronary stenoses, plan, and optimize coronary interventions.
  • OCT-FFR “Physio- Anatomy” data can be registered to coronary angiography data to provide a comprehensive tool for interventionalists to accurately plan and guide coronary procedures.
  • OCT-FFR simulations can be used to create a virtual stenting tool that allows the user of system 10 (e.g. an interventionalist) to simulate the effect of stents of different lengths and diameters over different vessel locations to optimize stent sizing and selection and devise an optimal intervention strategy.
  • Physio- Anatomy data can be quantified (e.g. by system 10) by the means of several metrics. For example, these metrics can be used to quantify the effect of the treatment pre-intervention vs. post-intervention (e.g. a “gain” quantification).
  • system 10 is configured to ensure data quality and suitability for CFD calculations.
  • system 10 can be configured to ensure confidence of segmentation results (e.g. side-branch and/or lumen segmentation), by determining a “confidence metric”, such as is described herein.
  • the goal of a confidence metric is to inform the user about potential images with reduced quality where segmentation results are uncertain, allowing for a quick visual review and correction (if needed).
  • system 10 can be configured to ensure that a complete pullback has been acquired, from a location distal to a lesion to the tip of the guide catheter.
  • a complete pullback can be defined as: a pullback that captured the entire disease; a pullback that did not start and/or end on a diseased vessel segment; and, if a stent is present, it is imaged in its entirety. If a pullback starts and ends on diseased vessel segments, system 10 can be configured to recover from this situation and provide an accurate CFD measurement. For example, in this scenario, system 10 can identify (e.g. via one or more methodologies described herein) healthy vessel segments and can be configured to use branching laws to estimate vessel diameters and/or areas in proximal and/or distal reference frames, for example as described in reference to Figs. 4A-4D herein.
  • system 10 is configured to perform an assessment of image quality comprising an assessment of the presence of significant blood residuals in the vessel lumen during a pullback, for example blood that obscures one or more portion of the vessel.
  • System 10 can be configured to perform an assessment as described in reference to Figs. 7A- 7D herein.
  • system 10 is configured to assess blood that is trapped with a portion of a catheter that is configured to be imaged through (e.g. a portion of a catheter that is configured to be purged with saline before and/or during a pullback), where the trapped blood degrades the image quality.
  • An example of incomplete catheter purging and its effects is shown in Fig. 13 described herein.
  • One or more algorithms of system 10 can be configured to automatically detect degradation in image quality as well as the degree of quality loss, and to warn the user about the poor image quality and potential need to repeat acquisition (e.g. to repeat the pullback).
  • system 10 is configured to capture one or more angiography images. Analysis of angiography data performed by system 10 can reveal the presence of major collateral vessels. In this case, FFR and CFD calculations might be inaccurate (e.g., false low FFR in the “donor artery” and/or false high FFR in the “recipient artery”).
  • a warning message can be displayed to the user to inform about presence of collateral vessels before a CFD calculation is performed by system 10 and/or before the results are displayed by system 10 to the user.
  • system 10 is configured to use various image processing techniques (e.g. as described herein) to help prevent incomplete and/or low-quality image data that can reduce the accuracy of CFD simulations for pressure-drop calculations.
  • An automated determination of image data quality can warn the user of system 10 about potential issues, can help the user in correcting some issues where possible (e.g. help and/or enable the user to fix inaccurate segmentation results), and/or can indicate to the user when a new image data acquisition might be necessary.
  • Automated assessment of data quality can warn and/or provide guidance to the user about moderate quality images and facilitate corrections.
  • a severe loss of image data quality that cannot be recovered can be displayed to the user, and system 10 can provide guidance on how to improve the image quality (e.g. direct the user to better purge the catheter, and/or to better engage the coronary ostium with the guide catheter) and perform an additional image acquisition.
  • system 10 can determine reference diameters (e.g. proximal and distal reference diameters) as well as the size of side-branches (e.g. as described in reference to Figs. 4A-D herein) and can use this information to calculate an “ideal” and/or “reference” vessel profile to better guide intervention and/or to quantify “stent expansion”.
  • An ideal vessel profile is a metric that can inform a more accurate stent sizing.
  • Stent expansion is a metric that can inform additional steps to optimize stent implantation procedures.
  • system 10 can be used as a tool to provide training, such as training to a clinician or other user of system 10, and/or can provide equipment diagnostics information in a clinical setting, such as self-diagnostic information and/or diagnostic information related to equipment in the clinical setting that is not a part of system 10.
  • system 10 can be configured to perform an initial and/or periodic assessment of the user of system 10, for example by comparing determinations made by the user (e.g. based on image data gathered by system 10 and input into system 10), to determinations made by system 10 (e.g. by algorithm 315/415) based on similar data (e.g. the same data).
  • system 10 can perform an automated image assessment (e.g. to determine if blood is present during imaging, if a guide catheter is properly positioned during imaging, and/or if a catheter lumen was sufficiently purged during imaging). Based on the automated assessment, system 10 can provide feedback to the user based on the user’s operation of system 10 and/or the users interpretation of the data. For example, system 10 can suggest IQ improvement, provide considerations based on the image quality assessment, and/or provide an overall pullback review.
  • an automated image assessment e.g. to determine if blood is present during imaging, if a guide catheter is properly positioned during imaging, and/or if a catheter lumen was sufficiently purged during imaging.
  • system 10 can provide feedback to the user based on the user’s operation of system 10 and/or the users interpretation of the data.
  • system 10 can suggest IQ improvement, provide considerations based on the image quality assessment, and/or provide an overall pullback review.
  • system 10 can perform an image quality assessment, and infer (e.g. via algorithm 315/415) from the image quality if a component of system 10 may be the cause of poor image quality.
  • system 10 can detect serviceable issues such as a failing imaging assembly 320 (e.g. from dim image data), poorly connected and/or broken connectors, and/or poor image registration (e.g. caused by NURD or other physical conditions of the catheter).
  • system 10 is configured to track the usage of various components of the system, for example the number of pullbacks for which an imaging probe 100 and/or an imaging assembly 320 has been used.
  • system 10 is configured to analyze a first set of image data collected by system 10, as well as a second set of image data from another imaging device (e.g. second imaging device 15), and to analyze (e.g. via algorithm 315/415) the image quality of the second set of image data, such as to provide a diagnostic report of the second imaging device (e.g. to determine if the second device is working properly or is in need of service and/or calibration).
  • another imaging device e.g. second imaging device 15
  • algorithm 315/415 the image quality of the second set of image data
  • system 10 is configured to perform an automated review of image data gathered by the system to ensure the image quality is sufficient to perform subsequent calculations based on the image data (e.g. FFR calculations described herein).
  • System 10 can be configured to identify various issues from image data, such as issues selected from the group consisting of: blood in the image, such as caused by inadequate blood clearing; reduced lumen wall confidence; image distortion, such as distortion caused by NURD; lack of guide catheter visualization; insufficient pullback distance, such as less than 40 mm; improper beginning and/or ending points of image data (e.g. starting and/or ending within a stent); and combinations of these.
  • system 10 is configured to analyze image data to determine if the patient meets any exclusion criteria (e.g. such that the patient would be excluded from further treatment and/or diagnosis by system 10).
  • Exclusion criteria identified by system 10 can include: presence of a chronic total occlusion (CTO) in the target vessel; severe diffuse disease in the target vessel (e.g. defined as the presence of diffuse, serial gross luminal irregularities present in the majority of the coronary tree); presence of myocardial bridge (MB); target lesion involves the Left Main (e.g.
  • CTO chronic total occlusion
  • severe diffuse disease in the target vessel e.g. defined as the presence of diffuse, serial gross luminal irregularities present in the majority of the coronary tree
  • MB myocardial bridge
  • target lesion involves the Left Main (e.g.
  • system 10 is configured to analyze angiography image data to identify a vessel within which imaging probe 100 is positioned (e.g. which vessel image data collected by system 10 represents).
  • one or more algorithms of system 10 e.g. algorithm 315/415
  • system 10 is configured to perform motion correction of OCT image data by analyzing velocity vectors of angiographic image data collected simultaneously with the OCT image data.
  • the image processing methodologies of system 10 described herein are configured to automatically perform a process selected from the group consisting of: identify normal and diseased segments of an imaged vessel; identify ideal reference frames for vessel sizing (e.g. to avoid placing a reference segment in a diseased area); optimize scaling laws by avoiding diseased segments as reference diameters; optimize vessel size estimation; and combinations of these.
  • Imaging probe 100 of Fig. 2 can be of similar construction and arrangement to, and include similar components as, imaging probe 100 described in reference to Fig. 1 and otherwise herein.
  • imaging probe 100 includes a shaft, outer shaft 140 as shown, including a lumen 141 within which another shaft, shaft 120 as shown, is rotatably and/or slidingly positioned.
  • PIU 200 (not shown but also described herein in reference to Fig.1) is configured to rotate optical core 110.
  • PIU 200 can be further configured to also retract optical core 110, shaft 120, or both (e.g. in unison) relative to outer shaft 140.
  • connector assembly 150 including shell 151 and inner shell 152 can be constructed and arranged to operably connect to a mating connector of PIU 200, into which inner shell 152 and connector 153 are retracted, thus shaft 120 can be retracted relative to outer shaft 140 by PIU 200.
  • PIU 200 can be configured to attach to and retract inner shell 151 and shaft 120 without rotating inner shell 151 and/or shaft 120 (e.g. to rotate connector 153 and shaft 110 relative to inner shell 152 and shaft 120, respectively.
  • At least a distal portion of shaft 140 comprises an optically transparent segment, such as window 142 shown.
  • window 142 comprises polyetheretherketone (PEEK), or another optically transparent material (e.g. at least partially transparent to light at the wavelength produced by light source 325).
  • Shaft 120 can be configured to be translated within shaft 140 such that optical assembly 115 translates within window 142 (e.g. within all or a portion of window 142).
  • the distal portion of optical core 110, including optical assembly 115 is positioned at a location within shaft 140 and beyond the distal end of shaft 120 (as shown in Fig. 2B).
  • gel 118 surrounds a distal portion of optical core 110 within shaft 120.
  • Imaging probe 100 including optical assembly 115 of Figs. 3 and 3 A can be of similar construction and arrangement to optical assembly 115 described in reference to Fig. 1 and otherwise herein.
  • Optical assembly 115 can include an elongate structure, housing 1120, that is constructed and arranged to maintain the position of various components of optical assembly 115, such as are described herein.
  • housing 1120 can be fixedly attached to the distal portion of optical core 110, as well as to a reflecting element, reflector 1130.
  • surface 1131 of reflector 1130 comprises a reflective coating, such as a gold plating.
  • optical core 110 is fixedly attached to housing 1120, such as with adhesive 1122 (as shown) and/or with another attachment element (e.g. a heat shrink tube).
  • adhesive 1122 comprises a glue configured to be cured with ultraviolet light.
  • housing 1120 comprises a material configured to enhance the visibility of optical assembly 115, for example a radiopaque material configured to be imaged using fluoroscopy, such that an operator of system 10 can identify the location of optical assembly 115 in a fluoroscopic image.
  • Surface 1131 of reflector 1130, and/or distal end 1109 of optical core 110 can each comprise a geometry configured to direct the path of light emitted from optical core 110 to tissue and/or a geometry configured to direct light reflected from tissue into optical core 110 (either or both, “direct” light herein), as described herein.
  • distal end 1109 comprises an angled surface, as shown (e.g. a surface that is not orthogonal to the axis of core 110), such as when optical core 110 comprises an angle-cleaved fiber and/or a fiber including an angled polish.
  • Housing 1120 can comprise an opening, opening 1121 shown. Surface 1131 and distal end 1109 can be configured to direct light through opening 1121.
  • housing 1120 can comprise an optically transparent material (e.g. an optically transparent window segment) through which light can be directed.
  • optical assembly 115 is positioned within shaft 140 and is surrounded by air (e.g. surrounded by a gas such as atmospheric air), such that the directed light travels through air between distal end 1109 and the wall of outer shaft 140.
  • air e.g. surrounded by a gas such as atmospheric air
  • the air gap between distal end 1109 and reflector 1130 allows the light to expand, and then the concave surface of reflector 1130 allows the light to be collimated.
  • Optical assembly 115 can be positioned in air within air (e.g. atmospheric air) within shaft, eliminating the need to purge shaft 140.
  • optical assembly 115 extends beyond the distal end of shaft 120 and is rotatably and slidingly positioned within the window 142 portion of outer shaft 140, such as is described in reference to Fig. 2B herein.
  • outer shaft 140 comprises inner diameter DI and outer diameter D4
  • optical assembly 115 e.g. lens housing 1120
  • lens housing 1120 comprises inner diameter D2
  • shaft 120 comprises inner diameter D5
  • optical assembly 115 comprises length LI.
  • diameter D3 of optical assembly 115 is greater than inner diameter D5 of shaft 120 (e.g. as optical assembly 115 is positioned distal to the distal end of shaft 120).
  • imaging probe 100 comprises a 1.8F shaft, for example when the dimensions of optical assembly 110 comprise approximately the following dimensions: DI can comprise a diameter between 0.010” and 0.045” (e.g. DI can comprise a diameter of at least 0.010” and/or a diameter of no more than 0.045”), such as a diameter of approximately 0.018”, D2 can comprise a diameter between 0.005” and 0.040”, such as a diameter of approximately 0.012”, D3 can comprise a diameter between 0.005” and 0.042”, such as a diameter of approximately 0.014”, and D4 can comprise a diameter between 0.012” and 0.050”, such as a diameter of approximately 0.023”.
  • LI comprises a length between 0.040” and 0.500” (e.g. a length of at least 0.040” and/or a length of no more than 0.500”).
  • reflector 1130 includes a projection, handle 1132, which is configured to be used during a manufacturing process, and eventually removed (e.g. removed and discarded).
  • Handle 1132 extends from a functional portion of reflector 1130, insert 1133, which can be inserted into housing 1120 during the manufacturing of optical assembly 115.
  • Surface 1131 is positioned on the proximal end of insert 1133 as shown.
  • a distal portion of insert 1133 can include a radial projection, shoulder 1134, that radially extends to a diameter greater than the inner diameter of housing 1120, such as to control (e.g. limit or establish) the depth that insert 1133 can be inserted into housing 1120.
  • Handle 1132 can include one or more alignment features, feature 1135, which can comprise a flat surface as shown.
  • system 10 includes an assembly tool, jig 70.
  • Feature 1135 can comprise a flat surface that slidingly mates with jig 70, such as a mating flat surface of jig 70, surface 71 shown in Fig. 4B.
  • alignment feature 1135 comprises a keyed or other shape that is configured to align handle 1132 with a mating shape of assembly jig 70.
  • Alignment feature 1135 can be rotationally aligned with surface 1131, such that when handle
  • System 10 can include an assembly tool, jig 75, constructed and arranged to assist a manufacturing assembler to rotationally align optical core 110 (e.g. distal end 1109 of optical core 110) with surface 1131 of reflector 1130 within housing 1120.
  • Alignment feature 1135 of reflector 1130 can mate with jig 75, such as with a flat surface 76 of jig 75, such that reflector 1130 and housing 1120 are rotationally fixed relative to jig 75.
  • Jig 75 can include a rotational tool, torquer 77, that removably attaches to optical core 110, such as to assist a manufacturing assembler in rotating optical core 110 to align distal end 1109 with surface 1131 of reflector 1130. Once aligned, optical core 110 can be affixed (e.g. glued) to housing 1120 with adhesive 1122. In manufacturing, after insert
  • torquer 77 comprises a robotically controlled component (e.g. via a robotic manipulator of calibration tool 50), such that the axial and rotational position of distal end 1109 of core 110 can be adjusted in a closed loop fashion (e.g. as calibration tool 50 analyzes the emitted light and robotically or otherwise adjusts the alignment to optimize the light emitted from optical assembly 115).
  • a robotically controlled component e.g. via a robotic manipulator of calibration tool 50
  • the axial and rotational position of distal end 1109 of core 110 can be adjusted in a closed loop fashion (e.g. as calibration tool 50 analyzes the emitted light and robotically or otherwise adjusts the alignment to optimize the light emitted from optical assembly 115).
  • FIG. 6 various views of an embodiment of a reflector are illustrated, consistent with the present inventive concepts.
  • Reflector 1130 including handle
  • 1133 of Figs. 6 A and 6B can be of similar construction and arrangement to insert 1133 described in reference to Fig. 3 A and otherwise herein.
  • Optical core 110 of Fig. 7 can be of similar construction and arrangement to optical core 110 described in reference to Fig. 1 and otherwise herein.
  • distal end 1109 of optical core 110 comprises an angled surface, such as a surface with an angle a as shown.
  • Angle a can comprise an angle between 0° and 20° (e.g. an angle of at least 0° and/or an angle of no more than 20°), such as between 8° and 12° (e.g. an angle of at least 8° and/or an angle of no more than 12°), such as an angle of approximately 8°.
  • Figs. 9A and 9B show nominal and offset light paths (e.g. non-nominal light paths caused by a misalignment between reflector 1130 and distal end 1109 of optical core 110).
  • the offset light paths shown represent approximately a 50pm offset.
  • the geometry (e.g. curvature) of surface 1131 is configured to prevent such offsets (e.g. offsets caused in a manufacturing process) from adversely affecting the focus of light leaving optical core 110.
  • the geometry (e.g. curvature) of surface 1131 is configured to avoid the creation of unwanted stray light.
  • FIG. 10A shows the path of modeled light exiting distal end 1109 of optical core 110 that reflects off of surface 1131 to a focal spot.

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  • Cardiology (AREA)
  • Vascular Medicine (AREA)
  • Physiology (AREA)
  • Endoscopes (AREA)

Abstract

L'invention concerne des systèmes d'imagerie destinés à un patient, comprenant une sonde d'imagerie et un ensemble d'imagerie. La sonde d'imagerie comprend : un premier arbre allongé; un deuxième arbre allongé a positionné à l'intérieur d'une lumière du premier arbre allongé; un cœur optique rotatif positionné à l'intérieur d'une lumière du deuxième arbre allongé; et un ensemble optique positionné à proximité d'une extrémité distale du cœur optique rotatif. L'ensemble optique peut diriger la lumière vers le tissu à imager et collecter la lumière réfléchie à partir du tissu à imager. L'ensemble d'imagerie peut émettre de la lumière dans la sonde d'imagerie et recevoir la lumière réfléchie collectée par l'ensemble optique.
EP23878031.6A 2022-10-14 2023-10-13 Système d'imagerie Pending EP4601534A1 (fr)

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
US202263416170P 2022-10-14 2022-10-14
US202363532223P 2023-08-11 2023-08-11
US202363542279P 2023-10-03 2023-10-03
PCT/US2023/035132 WO2024081414A1 (fr) 2022-10-14 2023-10-13 Système d'imagerie

Publications (1)

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EP4601534A1 true EP4601534A1 (fr) 2025-08-20

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EP (1) EP4601534A1 (fr)
JP (1) JP2025534710A (fr)
WO (1) WO2024081414A1 (fr)

Families Citing this family (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP6981967B2 (ja) 2015-08-31 2021-12-17 ジェンテュイティ・リミテッド・ライアビリティ・カンパニーGentuity, LLC 撮像プローブおよびデリバリデバイスを含む撮像システム
US12262872B2 (en) 2018-09-17 2025-04-01 Gentuity, Llc Imaging system with optical pathway
EP3962346A4 (fr) 2019-04-30 2023-04-19 Gentuity LLC Sonde d'imagerie dotée d'un élément de mise sous pression de fluide
WO2020237024A1 (fr) 2019-05-21 2020-11-26 Gentuity, Llc Systèmes et procédés pour un traitement de patients basé sur l'oct

Family Cites Families (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2019108598A1 (fr) * 2017-11-28 2019-06-06 Gentuity, Llc Système d'imagerie
US12262872B2 (en) * 2018-09-17 2025-04-01 Gentuity, Llc Imaging system with optical pathway
EP3962346A4 (fr) * 2019-04-30 2023-04-19 Gentuity LLC Sonde d'imagerie dotée d'un élément de mise sous pression de fluide
WO2020237024A1 (fr) * 2019-05-21 2020-11-26 Gentuity, Llc Systèmes et procédés pour un traitement de patients basé sur l'oct
EP4142567A4 (fr) * 2020-04-29 2024-06-26 Gentuity, LLC Système d'imagerie

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JP2025534710A (ja) 2025-10-17

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