Acute stroke revascularization/recanalization systems processes and products thereby

• US 9,198,687 B2
• Filed: 05/19/2008
• Issued: 12/01/2015
• Est. Priority Date: 10/17/2007
• Status: Active Grant

• Current Assignee: Covidien LP (Medtronic Plc)
• Original Assignee: Covidien LP (Medtronic Plc)
• Inventors: Ferrera, David A., Cragg, Andrew, Fulkerson, John
• Primary Examiner(s): FISHBACK, ASHLEY LAUREN
• Application Number:
  US12/123,390
• Publication Number:
  US 20090105737A1
• Time in Patent Office: 2,752 Days
• Field of Search: 604/93.01, 604/96.01, 604/507, 606191-192, 606/194, 606/200, 623 11- 112, 623 115- 116, 623/1.34, 623 139- 14
• 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 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
• 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 catheter-based acute stroke recanalization system configured to provide instant flow restoration of an occluded blood vessel of cerebral vasculature of a patient, comprising:

an outer catheter configured to be delivered over a guidewire to a location of an embolus within an occluded blood vessel of the cerebral vasculature of a patient;

an inner catheter having a length and diameter suitable to be sheathed within the outer catheter, the inner catheter and the outer catheter being longitudinally moveable with respect to each other, wherein the inner catheter is a stainless steel wire or a laser-cut, variable pitch hypotube; and

a self-expanding nitinol revascularization device coupled to a distal end of the wire or hypotube by a plurality of tethers, the self-expanding nitinol revascularization device having a compressed configuration when the revascularization device is sheathed within the outer catheter and an expanded configuration upon retraction of the outer catheter, the revascularization device comprising a first plurality of struts that form a plurality of rings, and a second plurality of struts that join the plurality of rings, each strut of the second plurality of struts between two adjacent rings being separated from (a) adjacent struts of the second plurality of struts between the two adjacent rings by four struts of the first plurality of struts in each of the two adjacent rings, and (b) another strut of the second plurality of struts positioned on a longitudinally opposing side of a ring of the plurality of rings by a single strut of the first plurality of struts, and, in the expanded configuration, each ring having a smaller diameter than has any proximally adjacent ring;

wherein, in use, the outer catheter is inserted through the embolus within the blood vessel of the cerebral vasculature and, upon retraction of the outer catheter, the self-expanding nitinol revascularization device transitions to the expanded configuration at the location of the embolus without mechanical actuation to compress the embolus against the luminal wall of the blood vessel to restore blood flow through the blood vessel;

wherein the revascularization device is a temporary, non-implantable device that is configured to retract back into the outer catheter for removal; and

wherein each strut of the second plurality of struts has a first end and a second end, the second end being offset from the first end about a circumference of the self-expanding nitinol revascularization device.

2. The acute stroke recanalization system of claim 1, wherein the inner catheter further comprises a polymeric jacket incorporated within the inner catheter to improve trackability of the guidewire.

3. The acute stroke recanalization system of claim 1, wherein said acute stroke recanalization system further comprises a plurality of apertures allowing infusable lytic agents to exit radially and distally into at least a subject embolus when transmitted through agent delivery device which is in fluid communication therewith.

4. The acute stroke recanalization system of claim 1, further comprising radiopacity for imaging purposes.

5. The acute stroke recanalization system of claim 4, said radiopacity further comprising at least one marker material selected from the group consisting essentially of platinum and gold.

6. The acute stroke recanalization system of claim 5, wherein the markers are pressed into pre-laser cut apertures designed to matingly embrace the markers.

7. The acute stroke recanalization system of claim 1, wherein said self-expanding nitinol revascularization device is configured to create a flow channel within the blood vessel of at least about 50% of the diameter of the blood vessel.

8. The acute stroke recanalization system of claim 1, wherein said self-expanding nitinol revascularization device comprises a coating or covering.

9. The acute stroke recanalization system of claim 1, wherein said inner catheter has an inner diameter of at least about 0.012 to 0.029 inches.

10. The acute stroke recanalization system 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.

11. The acute stroke recanalization system of claim 1, wherein said hypotube comprises a stainless steel hypotube.

12. The acute stroke recanalization system of claim 1, wherein said compression of the embolus against the luminal wall of the blood vessel further comprises morcellation of the embolus.

13. The acute stroke recanalization system of claim 1, wherein a distal segment of the outer catheter has an outer diameter that is less than an outer diameter of a proximal segment of the outer catheter.

14. The acute stroke recanalization system of claim 13, wherein the distal segment has a diameter of 2.7 French and the proximal segment has a diameter of 4 French.

15. A catheter-based acute stroke recanalization system configured to restore blood flow in an occluded blood vessel of cerebral vasculature of a patient, comprising:

an outer catheter configured to be delivered over a guidewire to a location of an embolus within the cerebral vasculature of a patient, the outer catheter having a distal end configured for insertion through the embolus;

an inner catheter having a length and diameter suitable to be sheathed within the outer catheter, the inner catheter and the outer catheter being longitudinally moveable with respect to each other, wherein the inner catheter is a wire or a variable-pitch hypotube; and

a self-expanding revascularization device coupled to a distal end of the wire or hypotube by a plurality of tether lines, at least a portion of the self-expanding revascularization device having a compressed configuration when the revascularization device is sheathed within the outer catheter and an expanded configuration upon retraction of the outer catheter, said revascularization device comprising a first plurality of struts that form a plurality of rings, and a second plurality of struts that join the plurality of rings, each strut of the second plurality of struts between two adjacent rings being separated from (a) adjacent struts of the second plurality of struts between the two adjacent rings by four struts of the first plurality of struts in each of the two adjacent rings, and (b) another strut of the second plurality of struts positioned on a longitudinally opposing side of a ring of the plurality of rings by a single strut of the first plurality of struts, and, in the expanded configuration, each ring having a smaller diameter than has any proximally adjacent ring;

wherein said revascularization device is configured to compress the embolus against a luminal wall of the blood vessel to restore blood flow through the blood vessel to facilitate natural lysis of the embolus;

wherein the revascularization device is a temporary, non-implantable device that is configured to retract back into the outer catheter for removal;

wherein, upon retraction of the outer catheter, the self-expanding revascularization device is configured to transition to the expanded configuration at the location of the embolus without mechanical actuation to compress the embolus against the blood vessel to restore blood flow through the blood vessel; and

wherein each strut of the second plurality of struts has a first end and a second end, the second end being offset from the first end about a circumference of the self-expanding revascularization device.

16. The acute stroke recanalization system of claim 15, wherein said recanalization system comprises one or more apertures to allow infusable lytic agents to contact and lyses the embolus.

17. The acute stroke recanalization system of claim 15, 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.

18. The acute stroke recanalization system of claim 15, wherein said compression of the embolus against the luminal wall of the blood vessel further comprises morcellation of the embolus.

19. A catheter-based acute stroke recanalization system configured to provide instant flow restoration of an occluded blood vessel of cerebral vasculature of a patient, comprising:

an outer catheter configured to be delivered over a guidewire to a location of an embolus within an occluded blood vessel of the cerebral vasculature of a patient;

an inner catheter being sheathed within and longitudinally moveable with respect to the outer catheter;

a self-expanding device coupled to a distal end of the inner catheter by a plurality of tether lines to facilitate resheathing of the self-expanding device into the outer catheter, the self-expanding device having a compressed configuration in which the -self-expanding device is sheathed within the outer catheter and an expanded configuration upon retraction of the outer catheter for removal, the self-expanding device comprising a first plurality of struts that form a plurality of rings, and a second plurality of struts that join the plurality of rings, each strut of the second plurality of struts between two adjacent rings being separated from (a) adjacent struts of the second plurality of struts between the two adjacent rings by four struts of the first plurality of struts in each of the two adjacent rings, and (b) another strut of the second plurality of struts positioned on a longitudinally opposing side of a ring of the plurality of rings by a single strut of the first plurality of struts, and, in the expanded configuration, each ring having a smaller diameter than has any proximally adjacent ring; and

wherein each strut of the second plurality of struts has a first end and a second end, the second end being offset from the first end about a circumference of the self-expanding device.

20. The acute stroke recanalization system of claim 19, wherein the self-expanding device comprises a stent.

21. The acute stroke recanalization system of claim 19, wherein a distal segment of the outer catheter has an outer diameter that is less than an outer diameter of a proximal segment of the outer catheter.

22. The acute stroke recanalization system of claim 21, wherein the distal segment has a diameter of 2.7 French and the proximal segment has a diameter of 4 French.