METHOD OF RESTORING BLOOD FLOW THROUGH AN OBSTRUCTED BLOOD VESSEL OF THE BRAIN

• US 20110190797A1
• Filed: 04/12/2011
• Published: 08/04/2011
• Est. Priority Date: 10/17/2007
• Status: Abandoned Application

• Current Assignee: Covidien LP (Medtronic Plc)
• Original Assignee: Mindframe LLC
• Inventors: Cragg, Andrew, Fulkerson, John, Ferrera, David A.
• Application Number:
  US13/084,880
• Publication Number:
  US 20110190797A1
• Time in Patent Office: Days
• 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 17/3207 Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions A61B17/32037 takes precedence; endoscopic cutting instruments A61B17/320016
• CPC Class Codes: A61B 17/320725 with radially expandable cutting or abrading elements A61B17/32075 takes precedence
• CPC Class Codes: A61B 2017/00845 of moving parts with respect to each other
• CPC Class Codes: A61B 2017/00867 shape memory effect for prostheses A61F2210/0014
• CPC Class Codes: A61B 2017/22038 with a guide wire
• CPC Class Codes: A61B 2017/22082 after introduction of a substance
• CPC Class Codes: A61F 2/013 Distal protection devices, i.e. devices placed distally in combination with another endovascular procedure, e.g. angioplasty or stenting
• CPC Class Codes: A61F 2/82 Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents stent-grafts for tubular structures of the body other than blood vessels A61F2/04; stent-grafts for blood vessels A61F2/07; instruments specially adapted for placement or removal of stents or stent-grafts A61F2/95; for closing wounds, or holding wounds closed A61B17/04 - A61B17/115; dilators A61M29/00
• CPC Class Codes: A61F 2250/0059 temporary
• CPC Class Codes: A61M 2025/1095 with perfusion means for enabling blood circulation while the balloon is in an inflated state or in a deflated state, e.g. permanent by-pass within catheter shaft
• CPC Class Codes: A61M 2025/1097 with perfusion means for enabling blood circulation only while the balloon is in an inflated state, e.g. temporary by-pass within balloon
• CPC Class Codes: A61M 29/02 Dilators made of swellable material balloon catheters for angioplasty A61M25/104

Abstract

An acute stroke recanalization system and processes include catheter-based improved reconstrainable or tethered neurological devices which are deliverable through highly constricted and tortuous vessels, crossing the zone associated with subject thrombi/emboli, where deployment impacts, addresses or bridges the embolus, compacting the same into luminal walls which enables perfusion and lysis of the embolus, while the improved neurological medical device itself remains contiguous with the delivery system acting as a filter, basket or stand alone stenting mechanism, depending on the status of the embolus and other therapeutic aspects of the treatment being offered for consideration.

Claims

1. A method of restoring blood flow through an obstructed blood vessel of the cerebral vasculature, comprising:

identifying an obstructed blood vessel within the cerebral vasculature of a patient, the obstructed blood vessel having an occlusive embolus;

inserting a catheter-based revascularization system within the obstructed blood vessel;

wherein the catheter-based revascularization system comprises an outer catheter and an inner catheter longitudinally moveable with respect to each other;

wherein the inner catheter comprises a pusher and a self-expandable revascularization device eccentrically tethered to a distal end of the pusher;

wherein the self-expandable revascularization device comprises a generally cylindrical body having an open proximal end, an open distal end, and a plurality of struts that form a plurality of cells between the proximal and distal ends;

positioning the outer catheter at a location distal to the embolus;

retracting the outer catheter to deploy the self-expandable revascularization device at the location of the embolus thereby compressing the embolus against a luminal wall of the blood vessel and restoring flow through the blood vessel;

wherein the restored blood flow facilitates natural lysis of the embolus;

wherein the natural lysis and compression of the embolus cause fragmentation of at least a portion of the embolus into a plurality of embolic fragments,

wherein one or more of said embolic fragments pass through the open distal end of the self-expandable revascularization device downstream of the embolus; and

wherein the self-expandable revascularization device exerts continuous radial pressure at the location of the embolus to further facilitate blood flow through the blood vessel as the embolus lyses;

resheathing the revascularization device within the outer catheter; and

removing the revascularization system from the patient.

2. The method of claim 1, wherein the revascularization device is permanently tethered to a distal end of the pusher.

3. The method of claim 1, wherein the revascularization device is detachably tethered to a distal end of the pusher.

4. The method of claim 1, wherein the revascularization device comprises radiopaque markers configured for tracking of the revascularization device.

5. The method of claim 4, further comprising tracking the revascularization device to confirm proper positioning with respect to the embolus.

6. The method of claim 1, wherein deploying the self-expandable revascularization device at the location of the embolus comprises creating an immediate flow channel within the blood vessel of at least about 50% of the diameter of the blood vessel of the cerebral vasculature.

7. The method of claim 1, wherein the pusher comprises a variable-pitch hypotube.

8. The method of claim 1, wherein the pusher comprises a wire.

9. The method of claim 1, wherein at least a portion of said inner catheter comprises a flexible material configured to permit flexion and extension to navigate through curved vessels of the cerebral vasculature.

10. The method of claim 1, further comprising infusing lytic agents to the location of the embolus through the revascularization system.

11. The method of claim 1, further comprising removing at least a portion of the embolus captured by the revascularization device.

12. The method of claim 1, wherein the revascularization device comprises a self-expanding microstent.

13. The method of claim 1, further comprising morselizing at least a portion of the embolus by mechanical manipulation of the revascularization device.

14. The method of claim 1, wherein inserting the catheter-based revascularization system within the obstructed blood vessel comprises advancing the revascularization system over a guidewire proximate a location of the embolus.

15. A method of restoring blood flow through an obstructed blood vessel of the brain to treat acute ischemic stroke, comprising:

identifying an obstructed blood vessel within the cerebral vasculature of a patient, the obstructed blood vessel having an embolus;

inserting a catheter-based revascularization system within the obstructed blood vessel;

wherein the catheter-based revascularization system comprises an outer catheter and an inner catheter longitudinally moveable with respect to each other;

wherein the inner catheter comprises a pusher and a self-expandable revascularization device tethered to a distal end of the pusher;

wherein the self-expandable revascularization device comprises an open proximal end, an open distal end, and a plurality of struts that form a plurality of cells between the proximal and distal ends;

positioning the outer catheter at a location distal to the embolus;

retracting the outer catheter, thereby deploying the self-expandable revascularization device at the location of the embolus, thereby compressing the embolus or lesion against a luminal wall of the obstructed blood vessel and restoring flow through the obstructed blood vessel;

wherein the restored blood flow facilitates natural lysis of the embolus;

wherein the natural lysis and compression of the embolus cause fragmentation of at least a portion of the embolus into a plurality of fragments,

wherein one or more of said fragments pass through the open distal end of the self-expandable revascularization device downstream of the embolus; and

wherein the self-expandable revascularization device exerts continuous radial pressure at the location of embolus to further facilitate blood flow through the blood vessel as the embolus lyses;

resheathing the revascularization device within the outer catheter; and

removing the revascularization system from the patient.

16. The method of claim 15, wherein the self-expandable revascularization device is generally cylindrical and eccentrically tethered to the distal end of the pusher via a plurality of tethered lines.

17. The method of claim 15, further comprising morselizing at least a portion of the embolus by mechanical manipulation of the revascularization device.

18. The method of claim 15, further comprising removing at least a portion of the embolus captured by the revascularization device.

19. The method of claim 15, wherein deploying the self-expandable revascularization device at the location of the embolus comprises creating an immediate flow channel within the blood vessel of at least about 50% of the diameter of the blood vessel of the cerebral vasculature.

20. The method of claim 15, wherein inserting a catheter-based revascularization system within the obstructed blood vessel comprises advancing the revascularization system over a guidewire proximate a location of the embolus.