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WO2025128443A1 - Procédé de traitement d'une sténose d'artère ophtalmique - Google Patents

Procédé de traitement d'une sténose d'artère ophtalmique Download PDF

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Publication number
WO2025128443A1
WO2025128443A1 PCT/US2024/059045 US2024059045W WO2025128443A1 WO 2025128443 A1 WO2025128443 A1 WO 2025128443A1 US 2024059045 W US2024059045 W US 2024059045W WO 2025128443 A1 WO2025128443 A1 WO 2025128443A1
Authority
WO
WIPO (PCT)
Prior art keywords
microcatheter
distal end
guidewire
stent
ophthalmic artery
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
PCT/US2024/059045
Other languages
English (en)
Inventor
Brent Charles GERBERDING
Murtagh M. Murphy
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.)
Stryker European Operations Ltd
Stryker Corp
Original Assignee
Stryker European Operations Ltd
Stryker Corp
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 Stryker European Operations Ltd, Stryker Corp filed Critical Stryker European Operations Ltd
Publication of WO2025128443A1 publication Critical patent/WO2025128443A1/fr
Pending legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/10—Balloon catheters
    • A61M25/104—Balloon catheters used for angioplasty
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/86—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
    • A61F2/90—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts
    • A61F2/962—Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve
    • A61F2/966—Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve with relative longitudinal movement between outer sleeve and prosthesis, e.g. using a push rod
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F9/00—Methods or devices for treatment of the eyes; Devices for putting in contact-lenses; Devices to correct squinting; Apparatus to guide the blind; Protective devices for the eyes, carried on the body or in the hand
    • A61F9/007—Methods or devices for eye surgery

Definitions

  • the field of the disclosure relates to medical devices and methods, and more specifically, to a method of treating ophthalmic artery stenosis with a medical system designed to access small artery.
  • Carotid artery stenosis is a narrowing of the carotid artery.
  • the carotid artery delivers oxygenated blood from the heart to the brain. Narrowing of the carotid artery can cause stroke or other conditions.
  • Age-related macular degeneration is an eye disease that can blur a person’s central vision. It can happen when aging causes damage to the macula, which is the part of the eye that controls sharp, straight-ahead vision.
  • a person’s vision may be negatively affected by the narrowing of ophthalmic artery that extends from the internal carotid artery. When the ophthalmic artery is blocked, it can cause the patient to lose his I her eyesight. This adverse condition, known as central retinal artery occlusion, can happen suddenly without any pain.
  • AMD may be related to ophthalmic artery stenosis (lesion) and may be treated by cannulizing the ophthalmic artery.
  • Ophthalmic artery stenosis is more difficult to treat than carotid artery stenosis. This is because the access to the ophthalmic artery requires a challenging navigation from the internal carotid artery into the ophthalmic artery via the ostium (opening) of the ophthalmic artery. This navigation is particularly challenging because the size of the ophthalmic artery ostium is quite small when compared to the internal carotid artery, especially if the ophthalmic artery stenosis occurs at the ostium (opening) of the ophthalmic artery.
  • the ophthalmic artery extends from the internal carotid artery at an angle that makes navigation of a treatment device from the internal carotid artery into the ophthalmic artery difficult.
  • the ophthalmic artery traverses adjacent to the optic nerve, thus increasing the risk of mechanical trauma to the artery and/or nerve when treating ophthalmic artery stenosis.
  • the difficulty in treating ophthalmic artery stenosis due to the acute take-off angle of the ophthalmic artery, and due to the lack of intravascular catheter-based devices that are designed specifically to access the ophthalmic artery are well-documented in “Ophthalmic artery angioplasty for age-related macular degeneration” by Ivan Lylyk et al.
  • New systems and techniques for treating ophthalmic artery stenosis are described herein.
  • the new systems and techniques allow treatment of ophthalmic artery stenosis to be performed easily, and minimize or at least reduce the risk of mechanical trauma to the artery and/or nerve in the treatment of ophthalmic artery stenosis.
  • a method of treating an ophthalmic artery lesion includes: advancing a distal end of a guidewire inside a patient into an ophthalmic artery through an ostium of the ophthalmic artery until the distal end of the guidewire passes a lesion in the ophthalmic artery; advancing a microcatheter over the guidewire until a distal end of the microcatheter is in the ophthalmic artery; removing the guidewire from within the microcatheter while the distal end of the microcatheter is in the ophthalmic artery; advancing a balloon catheter inside the microcatheter, wherein the balloon catheter comprises a balloon, and wherein the balloon catheter is without any guidewire lumen; deploying the balloon of the balloon catheter outside the microcatheter; and expanding the balloon to press against the lesion in the ophthalmic artery to create a compressed lesion.
  • the method further includes: deflating the balloon; and removing the balloon catheter from within the patient.
  • the act of advancing the microcatheter over the guidewire is performed while at least a part of the microcatheter is inside the guide catheter.
  • the distal end of the guide catheter remains in the internal carotid artery outside the ophthalmic artery.
  • the microcatheter 120 may be retracted proximally relative to the balloon catheter 130, and the balloon catheter 130 may be simultaneously advanced distally relative to the microcatheter 120, until the balloon 134 exits from the distal end 122 of the microcatheter 120.
  • the deployed position for the balloon 134 is at the lesion site (at the location of the lesion).
  • the balloon 134 may be deployed at a position that is distal to the lesion site.
  • the balloon catheter 130 may be retracted proximally to align the balloon 134 with the lesion 10 to be treated.
  • the balloon 134 is deflated, and the balloon catheter 130 is removed from within the patient.
  • the deflation of the balloon 134 may be accomplished by removing the inflation fluid inside the balloon 134, such as by suction.
  • the removal of the balloon catheter 130 may be achieved by retracting the balloon catheter 130 proximally until the balloon catheter 130 exits the patient.
  • the balloon catheter 130 may be retracted proximally relative to the guide catheter 160 to remove the balloon catheter 130 from within the patient.
  • the guide catheter 160 may then be retracted proximally to remove the guide catheter 160 from within the patient.
  • the engagement member 146 may have a connector that releasably connects to the stent 150.
  • the engagement member 146 may have a distal end that abuts the proximal end of the stent 150.
  • the stent-delivery device 140 may further include the148 sheath for housing the shaft, the engagement member, and the stent 150.
  • the stent-delivery device 140 includes the sheath 148 for housing the shaft 144, the engagement member 146, and the stent 150, then the placement of the distal end 142 of the stent-delivery device 140 at the lesion site involves placing the distal end of the sheath 148 at the lesion site.
  • the microcatheter 120 may be retracted proximally to cause the distal end of the sheath 148 to exit from the distal end 122 of the microcatheter 120.
  • the guidewire 110 may be removed from within the stent catheter (e.g., by retracting the guidewire 110 proximally) while the distal end of the stent catheter is in the ophthalmic artery 12. Then the shaft 144 of the stent-delivery device 140 and the stent 150 may be inserted into the stent catheter, and are then advanced distally, unit the stent 150 is deployed out of the distal end of the stent catheter.
  • the stent catheter may include a lumen dedicated for housing the guidewire 110.
  • the medical system 100 may optionally also include the stent delivery device 140 configured to deliver the stent 150 into the ophthalmic artery 12.
  • the system 100 for performing the method described herein should not be limited to having the configurations or features described.
  • the guide catheter 160 of the medical system 100 for performed the method described herein may be steerable. In such cases, the guide catheter 160 may be inserted into the patient and its distal end 162 is steered as the guide catheter 160 is being advanced distally to reach a target site (the internal carotid artery 20.
  • the microcatheter 120 is relatively more navigable than the balloon catheter 130, and has a smaller crossing profile. Furthermore, because the distal end 122 of the microcatheter 120 can be delivered past the ophthalmic artery lesion 10, the stent 150 can be delivered completely inside the ophthalmic artery 12 without any portion of the stent 150 protruding into the internal carotid artery 20.
  • the method 1000 further includes: deflating the balloon; and removing the balloon catheter from within the patient.
  • the method 1000 further includes advancing the microcatheter over the guidewire again until the distal end of the microcatheter is in the ophthalmic artery.
  • the method 1000 further includes: placing a stent-delivery device inside the microcatheter; and using the stent-delivery device to deploy a stent out of the distal end of the microcatheter, wherein the deployed stent compresses against the lesion.
  • the method 1000 further includes: removing the guidewire from within the stent catheter while the distal end of the stent catheter is in the ophthalmic artery; and deploying a stent out of the distal end of the stent catheter, wherein the deployed stent compresses against the lesion.
  • the method 1000 further includes deploying a stent out of the distal end of the stent catheter, wherein the deployed stent compresses against the lesion.
  • the act of advancing the microcatheter over the guidewire is performed while at least a part of the microcatheter is inside the guide catheter.
  • the act of advancing the balloon catheter inside the microcatheter is performed without placing the balloon catheter over the guidewire or any other guidewire.
  • the act of deploying the balloon comprises retracting the microcatheter proximally or advancing the balloon catheter distally.
  • the distal end of the microcatheter has a dimension that allows the distal end of the microcatheter to be placed inside the ophthalmic artery.
  • the medical system also comprises a stent delivery device configured to deliver a stent into the ophthalmic artery.

Landscapes

  • Health & Medical Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Anesthesiology (AREA)
  • Child & Adolescent Psychology (AREA)
  • Biophysics (AREA)
  • Pulmonology (AREA)
  • Engineering & Computer Science (AREA)
  • Vascular Medicine (AREA)
  • Biomedical Technology (AREA)
  • Hematology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Surgical Instruments (AREA)

Abstract

L'invention concerne un procédé de traitement d'une lésion d'artère ophtalmique qui consiste à : faire avancer une extrémité distale d'un fil-guide à l'intérieur d'un patient dans une artère ophtalmique à travers un ostium de l'artère ophtalmique jusqu'à ce que l'extrémité distale du fil-guide dépasse une lésion dans l'artère ophtalmique ; faire avancer un microcathéter sur le fil-guide jusqu'à ce qu'une extrémité distale du microcathéter se trouve dans l'artère ophtalmique ; retirer le fil-guide de l'intérieur du microcathéter tandis que l'extrémité distale du microcathéter est dans l'artère ophtalmique ; faire avancer un cathéter à ballonnet à l'intérieur du microcathéter, le cathéter à ballonnet comprenant un ballonnet, et le cathéter à ballonnet étant dépourvu de lumière de fil-guide ; déployer le ballonnet du cathéter à ballonnet à l'extérieur du microcathéter ; et dilater le ballonnet pour presser contre la lésion dans l'artère ophtalmique pour créer une lésion comprimée.
PCT/US2024/059045 2023-12-13 2024-12-06 Procédé de traitement d'une sténose d'artère ophtalmique Pending WO2025128443A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US202363609817P 2023-12-13 2023-12-13
US63/609,817 2023-12-13

Publications (1)

Publication Number Publication Date
WO2025128443A1 true WO2025128443A1 (fr) 2025-06-19

Family

ID=94227502

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2024/059045 Pending WO2025128443A1 (fr) 2023-12-13 2024-12-06 Procédé de traitement d'une sténose d'artère ophtalmique

Country Status (1)

Country Link
WO (1) WO2025128443A1 (fr)

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
FR2647681A1 (fr) * 1989-05-31 1990-12-07 Theron Jacques Appareil d'angioplastie pour arteres
US20050197688A1 (en) * 2003-10-16 2005-09-08 Minvasys, Sa Catheter system for protected angioplasty and stenting at a carotid bifurcation
US20100217372A1 (en) * 2007-05-15 2010-08-26 David Christian Lentz Hypotube catheter
US20200107851A1 (en) * 2018-10-04 2020-04-09 Neuravi Limited Retrograde Blood Flow Occlusion Flushing Device

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
FR2647681A1 (fr) * 1989-05-31 1990-12-07 Theron Jacques Appareil d'angioplastie pour arteres
US20050197688A1 (en) * 2003-10-16 2005-09-08 Minvasys, Sa Catheter system for protected angioplasty and stenting at a carotid bifurcation
US20100217372A1 (en) * 2007-05-15 2010-08-26 David Christian Lentz Hypotube catheter
US20200107851A1 (en) * 2018-10-04 2020-04-09 Neuravi Limited Retrograde Blood Flow Occlusion Flushing Device

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
IVAN LYLYK, OPHTHALMIC ARTERY ANGIOPLASTY FOR AGE-RELATED MACULAR DEGENERATION

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