ACUTE STROKE REVASCULARIZATION/RECANALIZATION SYSTEMS PROCESSES AND PRODUCTS THEREBY

• US 20090105737A1
• Filed: 05/19/2008
• Published: 04/23/2009
• Est. Priority Date: 10/17/2007
• Status: Active Grant

• Current Assignee: Covidien LP (Medtronic Plc)
• Original Assignee: Mindframe LLC
• Inventors: Fulkerson, John, Ferrera, David A., Cragg, Andrew
• Granted Patent: US 9,198,687 B2
• 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. An acute stroke recanalization system, comprising, in combination:

a catheter-based system with a guidewire effective for accessing of, and emplacement into, the cerebral vasculature of an improved neurological medical device;

at least one improved neurological medical device selected from the group consisting of a proximal stainless steel pusher, having a proximal end and distal tip, and a distal nitinol device; and

a one-piece nitinol device;

wherein the at least one improved neurological device further comprises a polymeric liner incorporated within the pusher to improve trackability of the guidewire, whereby the polymeric liner extends beyond the distal tip of the pusher for guiding the guidewire and preventing entanglement in the nitinol device.

2. The acute stroke recanalization system of claim 1, wherein the at least one improved neurological device further comprises a polymeric liner incorporated within the pusher to improve trackability of the guidewire, whereby the polymeric liner extends beyond the distal tip of the pusher for guiding the guidewire and preventing entanglement in the nitinol device.

3. The acute stroke recanalization system of claim 2, wherein said polymeric lining is further comprised of a plurality of apertures allowing infusible lytic agents to exit radially and distally into at least a subject embolus when transmitted through agent delivery device which is fluid communication therewith.

4. The acute stroke recanalization system of claim 3, the at least one improved neurological medical device being the proximal stainless steel pusher, having a proximal end and distal tip, and a distal nitinol device wherein the polymeric liner extends beyond the distal tip of the pusher to a length greater than the length of said distal nitinol device to protectingly direct the guidewire from entanglement in said distal nitinol device.

5. The acute stroke recanalization system of claim 4, wherein recapturability flexibility and tracking are enabled by the struts of the at least one improved neurological medical device, which permit flexion/extension to navigate through cured vessels.

6. The acute stroke recanalization system of claim 5, said at least one improved neurological medical device further comprising uniform cells.

7. The acute stroke recanalization system of claim 5, said at least one improved neurological medical device further comprising variable cell sizes

8. The acute stroke recanalization system of claim 7, whereby the variable cell sizes impact the exposed surface area of blood clots enmeshed therein.

9. The acute stroke recanalization system of claim 6, further comprising radiopacity for imaging purposes.

10. The acute stroke recanalization system of claim 9, said radiopacity further comprising at least one marker material selected from the group consisting essentially of platinum and gold.

11. The acute stroke recanalization system of claim 10, wherein the markers are pressed into pre-laser cut apertures designed to matingly embrace the same.

12. An improved acute stroke revascularization process, which comprises, in combination:

providing a reconstrainable self-expanding microstent system;

deploying a self-expanding microstent within a neurological artery;

achieving at least one of revascularization and recanalization of a subject vessel;

and removing the self-expanding microstent.

13. The improved acute stroke revascularization process of claim 12, further comprising:

at least one supplemental therapy from the group of pharmacological thrombolytic agents, intraarterial thrombolytics, and mechanical manipulation.

14. A surgical product, by the process of claim 13, which delivered endovascularly.

15. An improved neurological medical device comprising, in combination:

a catheter system effective for delivering a combination radial filter/revascularization device and basket-like assembly into a desired location in the cerebral vascular system;

a self-expanding radial filter/revascularization device and basket assembly detachably tethered to the catheter system which functions in at least three respective modes;

wherein the radial filter/revascularization device and basket-like assembly is attached to the catheter and wherein filter/revascularization device and basket assembly further comprises at least two states per mode, a retracted state and an expanded state; and

wherein the radial filter/revascularization device and basket-like assembly are retracted into the retracted state after deployment in an expanded state, in each mode.

16. The improved neurological medical device of claim 15, wherein the revascularization device is made from at least one of nitinol and spring tempered stainless steel.

17. The improved neurological medical device of claim 16, further comprising:

an infusion catheter and agent delivery system in fluid communication whereby agents are delivered to the site of a embolus.

18. A minimally invasive surgical process, comprising, in combination:

providing a revascularization device tethered to a catheter, which revascularization device may be at least one of removed post emplacement and implanted, further comprising;

emplacing the system into a patient for travel to a desired location in a vessel;

moving the system to a desired location in a vessel having an obstruction/lesion/embolus deploying the revascularization device by allowing it to move from a first state to a second state across a lesion;

compressing a subject embolus into a luminal wall to which it is adjacent; and

creating a channel for blood flow as a lytic agent, and removing the system which the obstruction/lesion is addressed.

19. The minimally invasive surgical process of claim 19, whereby the revascularization device tethered to a catheter functions as a radial filter to prevent downstream migration of emboli.

20. The minimally invasive surgical process of claim 19, whereby, optionally, the revascularization device remains deployed as an implant.