Embolectomy devices and methods for treatment of acute ischemic stroke condition

• US 8,814,892 B2
• Filed: 04/12/2011
• Issued: 08/26/2014
• Est. Priority Date: 04/13/2010
• Status: Active Grant

• Current Assignee: Mivi Neuroscience, Inc.
• Original Assignee: Mivi Neuroscience LLC
• Inventors: Galdonik, Jason A., Wlodarski, Grazyna, Kirchgessner, John, Ganesan, Kavitha, Ogle, Matthew F.
• Primary Examiner(s): FISHBACK, ASHLEY LAUREN
• Application Number:
  US13/085,109
• Publication Number:
  US 20110251629A1
• Time in Patent Office: 1,232 Days
• Field of Search: 606/108, 606/127, 606/128, 606/159, 606/200, 623/1.11, 623/1.12, 623/1.54
• US Class Current: 606/159
• 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 at least one bundle of unwoven fibers, 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 and 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 to have dimensions suitable to conform to the changing inner perimeter of a blood vessel, and an actuation tool that slides over the flexible delivery wire wherein the actuation tool is configured to engage the bundle to transition the fibers to the extended deployed configuration,

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.

2. 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.

3. 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.

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

5. The device of claim 1 wherein the fiber based element comprises a plurality of unwoven fiber bundles.

6. The device of claim 5 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.

7. The device of claim 5 wherein the plurality of fiber bundles each have its own attachment element.

8. The device of claim 5 wherein fiber bundles have one or both ends of the fibers secured.

9. The device of claim 1 further comprising heat shrink wrap around a portion of the fiber bundle such that the wrap forms a jacket around a portion of the fiber-based structure in the second configuration.

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

11. The device of claim 10 wherein the supplemental engagement structure is a filament structure comprising a plurality of polymeric filaments, wherein the polymeric filaments are substantially thicker than the fibers in the fiber bundle.

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

13. The device of claim 1 further comprising a mechanical treatment device delivered on the flexible wire.

14. The device of claim 13 wherein the mechanical treatment device is an atherectomy device, a stent, or an angioplasty balloon.

15. The device of claim 1 wherein the actuation tool is a microcatheter.

16. The device of claim 1 wherein the actuation tool comprises a filament cartridge comprising a plurality of filaments.

17. A system for the treatment of an acute stroke comprising:

the fiber based clot engagement element of claim 1,

wherein the actuation tool has a tubular distal end with an inner diameter such that the distal tip of the actuation tool slides over the delivery wire to deploy the fibers of the fiber-based clot engagement element to the second flared configuration; and

an aspiration catheter comprising a lumen with a distal opening in which the aspiration catheter can be delivered over the flexible delivery wire.

32. The device of claim 1 wherein the first attachment element comprises a slide and 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.

18. An acute stroke treatment device comprising a flexible delivery wire and a fiber-based clot engagement element that comprises a plurality of unwoven fiber bundles wherein each of the bundles of fibers have a first low profile delivery configuration and a second deployed configuration with a portion of the fibers that is unsecured flaring outward relative to the delivery wire to have dimensions suitable to conform to the changing inner perimeter of a blood vessel, a first attachment comprising a loop extending around the circumference of the delivery wire, a second attachment element comprising a loop extending around the circumference of the delivery wire, and an actuation tool that slides over the flexible delivery wire wherein the actuation tool is configured to engage the plurality of bundles of fibers to transition the fibers to the second deployed configuration,

wherein each fiber of a first bundle of the plurality of bundles is secured at one end to the first attachment element,

wherein each fiber of a second bundle of the plurality of bundles is secured at one end to the second attachment element and wherein the second attachment element can slide over the delivery wire without attachment to the actuation tool,

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.

19. The device of claim 18 wherein the unwoven fibers in the first configuration are substantially parallel to each other along the delivery wire in the bundle.

20. The device of claim 18 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.

21. The device of claim 18 further comprising a radio-opaque band on the first attachment element.

22. The device of claim 18 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, wherein each of the plurality of fiber bundles has its own attachment element.

23. The device of claim 18 wherein fiber bundles have one or both ends of the fibers secured.

24. The device of claim 18 further comprising heat shrink wrap around a portion of the fiber bundle such that the wrap forms a jacket around a portion of the fiber-based structure in the second configuration.

25. The device of claim 18 further comprising a supplemental engagement structure mounted or delivered on the flexible wire.

26. The device of claim 25 wherein the supplemental engagement structure is a filament structure comprising a plurality of polymeric filaments, wherein the polymeric filaments are substantially thicker than the fibers in the fiber bundle.

27. The device of claim 25 wherein the supplemental engagement structure is a Nitinol frame comprising a plurality of self-extendable Nitinol wires.

28. The device of claim 18 further comprising a mechanical treatment device delivered on the flexible wire.

29. The device of claim 18 wherein the actuation tool is not fixedly attached to an attachment element securing fibers of a bundle.

30. The device of claim 29 wherein the actuation tool is a microcatheter.

31. The device of claim 18 wherein the first attachment element comprises a slide that can translate over the delivery wire.