EMBOLECTOMY DEVICES AND METHODS FOR TREATMENT OF ACUTE ISCHEMIC STROKE CONDITION

• US 20170164964A1
• Filed: 02/02/2017
• Published: 06/15/2017
• Est. Priority Date: 04/13/2010
• Status: Active Grant

• Current Assignee: Mivi Neuroscience, Inc.
• Original Assignee: Mivi Neuroscience, Inc.
• Inventors: Galdonik, Jason A, Kirschgessener, John, Ogle, Matthew F, Wlodarski, Grazyna, Ganesan, Kavitha
• Granted Patent: US 10,485,565 B2
• Time in Patent Office: Days
• CPC Class Codes: A61B 17/221 Gripping devices in the form of loops or baskets for gripping calculi or similar types of obstructions surgical snare instruments A61B17/32056
• CPC Class Codes: A61B 2017/22044 with a pointed tip
• CPC Class Codes: A61B 2017/22067 Blocking; Occlusion A61B2017/22054 takes precedence
• CPC Class Codes: A61B 2017/22079 with suction of debris
• CPC Class Codes: A61B 2017/22094 for crossing total occlusions, i.e. piercing
• CPC Class Codes: A61B 2017/2212 having a closed distal end, e.g. a loop
• CPC Class Codes: A61B 2017/320716 comprising means for preventing embolism by dislodged material
• CPC Class Codes: A61F 2/012 Multiple filtering units
• CPC Class Codes: A61F 2002/016 made from wire-like elements
• CPC Class Codes: A61F 2230/0065 toroidal, e.g. ring-shaped, doughnut-shaped
• CPC Class Codes: A61F 2230/0076 ellipsoidal or ovoid
• CPC Class Codes: A61F 2230/0097 Harpoon-shaped

Abstract

Clot engagement element comprising bundle of unwoven fibers can be assembled to form an acute stroke treatment device. The device has the capability of forming a three dimensional filtration matrix comprising effective pores with a distribution of sizes. The bundle of fiber design allows the device to be effectively delivered into circuitous cerebral arteries to remove clot that causes stroke. The fiber bundle based filtration matrix offers the advantages of conforming to the changing inner perimeter of a blood vessel during a clot removal process and thus the capability to effectively retain and remove a clot in the vessel. The filtration matrix offers the additional advantage to trap any break-off of the clot during the removal process. A plurality of fiber bundles can be combined to form an effective clot engagement element. Supplemental engagement structure as well as mechanical treatment structure can be integrated into the stroke treatment device. The deployment of the fiber based elements can be facilitated by actuation tool. Aspiration can be employed during the clot removal process.

Claims

1. An acute stroke treatment device comprising a flexible delivery wire and a fiber-based clot engagement element that comprises a self-actuation structure, a bundle of unwoven fibers, and a first attachment element extending around the circumference of the flexible delivery wire wherein each fiber of the bundle is secured at one end to the first attachment element,

wherein the bundle of fibers have a first low profile delivery configuration and a second extended, deployed configuration with a portion of the fibers flaring outward relative to the flexible delivery wire,

wherein the first attachment element either comprises a slide that can translate over the delivery wire or an anchor that is secured at a fixed position around the circumference of the delivery wire, and

wherein the other end of the fibers are unsecured or are secured in a bundle at a second attachment element.

2. The device of claim 1 wherein the self-actuation structure comprises struts.

3. The device of claim 2 wherein the struts comprise a shape memory metal.

4. The device of claim 1 wherein the unwoven fibers in the first configuration are substantially parallel to each other along the delivery wire in the bundle.

5. The device of claim 1 wherein the fibers in the second configuration form a three dimensional filtration matrix comprising effective pores with a distribution of sizes within the matrix while the fibers remain unwoven.

6. The device of claim 1 further comprising a radio-opaque band on the first attachment element.

7. The device of claim 1 wherein the fiber based element comprises a plurality of unwoven fiber bundles and wherein a long non-woven fiber bundle is anchored at one or more positions along the fiber around the circumference of the flexible wire to form the plurality of fiber bundles that are inter-connected to each other.

8. The device of claim 1 further comprising a microcatheter that can slide over the flexible delivery wire to cover the fiber-based clot engagement element.

9. The device of claim 1 further comprising a supplemental engagement structure mounted or delivered on the flexible wire.

10. The device of claim 9 wherein the supplemental engagement structure is a Nitinol frame comprising a plurality of self-extendable Nitinol wires.

11. A method for the deployment of a clot engagement device within a cerebral artery, the method comprising:

delivering the clot engagement device to a cerebral artery downstream from the interior carotid artery, wherein the clot engagement device comprises a self-extending structure, flexible polymer fibers and a first attachment element extending around a circumference of the delivery wire wherein each fiber is secured at an end to the first attachment element, wherein the delivering of the clot engagement device comprises retracting a microcatheter over the flexible wire to release the clot engagement device that deploys to an extended configuration with the flexible polymer fibers conforming to the inner perimeter of the cerebral artery and an unwoven fiber mat is formed.

12. The method of claim 11 wherein the delivering of the clot engagement device further comprises:

delivering a guidewire to access the cerebral artery;

delivering a microcatheter over the guidewire to access the cerebral artery;

retrieving the guidewire;

delivering the clot engagement device on the flexible wire through the microcatheter to access the cerebral artery.

13. The method of claim 11 wherein the flexible wire is advanced directly to access the cerebral artery.

14. The method of claim 11 wherein the self-extending structure comprises struts.

15. The method of claim 14 wherein the struts comprise spring metal.

16. The method of claim 11 wherein the first attachment element comprises a slide that can slide over the flexible wire and wherein the other end of the fibers are unsecured or are attached to a second attachment element that can slide over the flexible wire.

17. The method of claim 11 wherein the first attachment element comprises an anchor that is secured at a fixed position around the circumference of the flexible wire and wherein the other end of the fibers are attached to a second attachment element that can slide over the flexible wire.

18. A method for the removal of a clot from a cerebral artery causing an acute stroke event, the method comprising:

positioning a self-extending fiber-based clot engagement device inside the cerebral artery distal to the blood clot, wherein the fiber-based clot engagement device is supported on a delivery wire;

withdrawing a microcatheter proximally to release the fiber-based clot engagement device that deploys to an extended configuration with at least a portion of the fibers extending outward relative to the delivery wire to conform to the inner perimeter of the cerebral artery;

pulling the deployed clot engagement device towards a distal opening of an aspiration catheter so the clot engagement device becomes engaged with the clot, wherein the fibers of the clot engagement device remain conforming to the changing inner perimeter of the arteries and thereby remain engaging the clot during the pulling process, and

applying aspiration through the aspiration catheter while drawing the clot toward the aspiration catheter with proximal movement of the clot engagement device, wherein the fiber-based clot engagement device comprises at least one bundle of unwoven fibers and a first attachment element extending around the circumference of the delivery wire wherein each fiber of the bundle is secured at one end to the first attachment element.

19. The method of claim 18 wherein the clot engagement device further comprises a supplemental engagement structure.

20. The method of claim 19 wherein the supplemental engagement structure is a filament structure comprising a plurality of polymeric filaments, a Nitinol frame comprising a plurality of self-extendable Nitinol wires, or a combination thereof.

21. The method of claim 18 further comprising deploying an occlusive balloon mounted near the distal end of the aspiration catheter to occlude carotid artery during aspiration.

22. The method of claim 18 wherein the clot engagement device allows blood to pass through.

23. The method of claim 18 further comprising breaking the clot into fragments by pulling the aspiration catheter and the clot engagement device against each other during the aspiration.

24. The method of claim 18 wherein the fiber-based clot engagement device comprises at least one bundle of unwoven fibers and a first attachment element extending around the circumference of the delivery wire wherein each fiber of the bundle is secured at one end to the first attachment element;

wherein the first attachment element either comprises a slide that can translate over the delivery wire or an anchor that is secured at a fixed position around the circumference of the delivery wire; and

wherein if the first attachment element has an anchor fixed to the delivery wire, the other end of the fibers are unsecured or are secured in a bundle at a second attachment element without fixed attachment to the actuation tool and wherein if the first attachment element comprises a slide that can translate over the delivery wire, the other end of the fibers are unsecured or are attached to a second attachment element that can slide over the delivery wire.