Embolectomy devices and methods for treatment of acute ischemic stroke condition

• US 9,597,101 B2
• Filed: 08/01/2014
• Issued: 03/21/2017
• Est. Priority Date: 04/13/2010
• Status: Active Grant

• Current Assignee: Mivi Neuroscience, Inc.
• Original Assignee: Mivi Neuroscience, Inc.
• Inventors: Galdonik, Jason A, Ogle, Matthew F, Wlodarski, Grazyna, Kirschgessner, John, Ganesan, Kavitha
• Primary Examiner(s): FISHBACK, ASHLEY LAUREN
• Application Number:
  US14/449,358
• Publication Number:
  US 20140371782A1
• Time in Patent Office: 963 Days
• US Class Current: 1/1
• 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. A method for the delivery of a clot engagement device within a cerebral artery, the method comprising:

delivering the clot engagement device to a cerebral artery downstream from an interior carotid artery, wherein the clot engagement device comprises a fiber-based clot engagement element supported by a delivery wire, wherein the fiber-based clot engagement structure comprises 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;

delivering a guidewire to access the cerebral artery,

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

retrieving the guidewire; and

delivering the clot engagement device on the delivery wire through the microcatheter to access the cerebral artery; and

advancing an actuation element comprising a push catheter over the delivery wire to engage the first attachment element and to deploy the fiber-based element to an extended configuration with the fibers forming a fiber mat and conforming to an inner perimeter of an artery, wherein the advancement of the actuation element is unconstrained over the delivery wire.

2. The method of claim 1 wherein the delivery wire is advanced directly to access the cerebral artery.

3. The method of claim 1 further comprising pulling a distal opening of the microcatheter behind the clot engagement device to expose the clot engagement device inside the cerebral artery, and then pushing the microcatheter forward against the clot engagement device to actuate the device.

4. The method of claim 1 wherein the actuation element is a push catheter coupled with a deployment tool comprising a filament cartridge and the filament cartridge is deployed into an extended configuration before helping to deploy the clot engagement device.

5. The method of claim 4 wherein the filament cartridge comprises a plurality of filaments that can be a filament bundle, triangular shaped filaments, or star shaped filaments.

6. The method of claim 4 further comprising using the push catheter to push the deployed deployment tool to deploy the clot engagement device.

7. The method of claim 1 wherein the fiber-based clot engagement element comprises at least one bundle of unwoven fibers.

8. The method of claim 7 wherein the first attachment element comprises a slide that can translate over the delivery wire wherein the other end of the fibers are unsecured or are attached to a second attachment element that can slide over the delivery wire.

9. The method of claim 7 wherein the fiber-based clot engagement element further comprises a second attachment element and wherein the other end of the fibers are secured in a bundle around the second attachment element.

10. The method of claim 1 wherein the actuation element is configured to engage the bundle to transition the fibers to the extended configuration.

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

positioning a fiber-based clot engagement device comprising fibers inside the cerebral artery distal to the blood clot on a delivery wire;

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

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

applying aspiration through the aspiration catheter while drawing the clot into the aspiration catheter with proximal movement of the clot engagement device while the clot engagement structure remains in a deployed configuration.

12. The method of claim 11 further comprising dislodging the clot with a mechanical treatment device comprising a clot engagement structure.

13. The method of claim 12 wherein the mechanical treatment device is an atherectomy device, a stent, or an angioplasty balloon.

14. The method of claim 11 wherein the clot engagement device further comprises a plurality of polymeric filaments, a Nitinol frame comprising a plurality of self-extendable Nitinol wires, or a combination thereof.

15. The method of claim 11 further comprising deploying an occlusive balloon mounted near a distal end of the aspiration catheter to occlude carotid artery during aspiration.

16. The method of claim 11 wherein the clot engagement device allows blood to pass through.

17. The method of claim 11 further comprising breaking the clot into fragments by pulling the aspiration catheter and the clot engagement device against each other during the aspiration.

18. The method of claim 11 wherein the deploying of the fiber based clot engagement device comprises sliding an actuation tool over the delivery wire to engage the fiber based 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 a circumference of the delivery wire wherein each fiber of the bundle is secured at one end to the first attachment element;

wherein the actuation tool is configured to engage the bundle to transition the fibers to the extended 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.

19. A method for the delivery 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 fiber-based clot engagement element supported by a delivery wire, wherein the fiber-based clot engagement element 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 and wherein the first attachment element comprises a slide that can translate over the delivery wire wherein the other end of the fibers are unsecured or are attached to a second attachment element that can slide over the delivery wire; and

advancing an actuation element over the delivery wire to deploy the fiber-based element to an extended configuration with the fibers conforming to the inner perimeter of the arteries, wherein the movement of the actuation element is unconstrained over the delivery wire.