Methods And Systems For Treatment Of Acute Ischemic Stroke

• US 20170368309A1
• Filed: 09/08/2017
• Published: 12/28/2017
• Est. Priority Date: 12/23/2013
• Status: Active Grant

• Current Assignee: Route 92 Medical, Inc.
• Original Assignee: Route 92 Medical, Inc.
• Inventors: Garrison, Michi E., Chou, Tony M.
• Granted Patent: US 11,318,282 B2
• Time in Patent Office: Days
• CPC Class Codes: A61B 17/22 Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for dilators A61M29/00
• CPC Class Codes: A61B 17/320758 with a rotating cutting instrument, e.g. motor driven A61B17/320725, A61B17/32075 and A61B17/320783 take precedence; for removing intra-ocular material A61F9/00763; endoscopic rotatable cutting instruments A61B17/32002
• CPC Class Codes: A61B 17/3417 Details of tips or shafts, e.g. grooves, expandable, bendable; Multiple coaxial sliding cannulas, e.g. for dilating syringe needles A61M5/32; dilators A61M29/00
• CPC Class Codes: A61B 2017/00867 shape memory effect for prostheses A61F2210/0014
• CPC Class Codes: A61B 2017/00991 Telescopic means
• CPC Class Codes: A61B 2017/22034 for gripping the obstruction or the tissue part from inside
• CPC Class Codes: A61B 2017/22038 with a guide wire
• CPC Class Codes: A61B 2017/22039 eccentric
• CPC Class Codes: A61B 2017/22042 Details of the tip of the guide wire
• CPC Class Codes: A61B 2017/22054 with two balloons
• CPC Class Codes: A61B 2017/22062 to be filled with liquid
• CPC Class Codes: A61B 2017/22067 Blocking; Occlusion A61B2017/22054 takes precedence
• CPC Class Codes: A61B 2017/22072 with an instrument channel, e.g. for replacing one instrument by the other in cannulas A61B17/3417
• CPC Class Codes: A61B 2017/22074 the instrument being only slidable in a channel, e.g. advancing optical fibre through a channel
• CPC Class Codes: A61B 2017/22079 with suction of debris
• CPC Class Codes: A61B 2017/22082 after introduction of a substance
• CPC Class Codes: A61B 2017/22084 stone- or thrombus-dissolving
• 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 2017/2215 having an open distal end
• CPC Class Codes: A61B 2017/2217 : single wire changing shape to a gripping configuration
• CPC Class Codes: A61B 2017/320775 : Morcellators, impeller or propeller like means
• CPC Class Codes: A61B 2017/3484 : Anchoring means, e.g. spreading-out umbrella-like structure
• CPC Class Codes: A61B 2017/3486 : Balloon
• CPC Class Codes: A61B 2090/062 : penetration depth
• 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: A61M 2025/0004 : having two or more concentrically arranged tubes for forming a concentric catheter system
• CPC Class Codes: A61M 2025/0037 : characterized by lumina being arranged side-by-side
• CPC Class Codes: A61M 2025/0042 : Microcatheters, cannula or the like having outside diameters around 1 mm or less
• CPC Class Codes: A61M 2025/0175 : having telescopic features, interengaging nestable members movable in relations to one another
• CPC Class Codes: A61M 2025/0681 : Systems with catheter and outer tubing, e.g. sheath, sleeve or guide tube
• CPC Class Codes: A61M 2025/1052 : for temporarily occluding a vessel for isolating a sector
• CPC Class Codes: A61M 2210/12 : Blood circulatory system
• CPC Class Codes: A61M 25/0023 : by the form of the lumen, e.g. cross-section, variable diameter
• CPC Class Codes: A61M 25/0041 : pre-formed, e.g. specially adapted to fit with the anatomy of body channels urethral catheters A61F2/04
• CPC Class Codes: A61M 25/0043 : characterised by structural features
• CPC Class Codes: A61M 25/0054 : with regions for increasing flexibility
• CPC Class Codes: A61M 25/0068 : Static characteristics of the catheter tip, e.g. shape, atraumatic tip, curved tip or tip structure
• CPC Class Codes: A61M 25/007 : Side holes, e.g. their profiles or arrangements; Provisions to keep side holes unblocked
• CPC Class Codes: A61M 25/01 : Introducing, guiding, advancing, emplacing or holding catheters A61M25/10 takes precedence
• CPC Class Codes: A61M 25/0662 : Guide tubes
• CPC Class Codes: A61M 29/00 : Dilators with or without means for introducing media, e.g. remedies instruments for performing visual medical inspections of cavities or tubes of the body A61B1/00

Abstract

A system of devices for treating an artery includes an arterial access sheath adapted to introduce an interventional catheter into an artery and an elongated dilator positionable within the internal lumen of the sheath body. The system also includes a catheter formed of an elongated catheter body sized and shaped to be introduced via a carotid artery access site into a common carotid artery through the internal lumen of the arterial access sheath. The catheter has an overall length and a distal most section length such that the distal most section can be positioned in an intracranial artery and at least a portion of the proximal most section is positioned in the common carotid artery during use.

Claims

1. A method of performing a medical procedure in a patient to treat stroke, the method comprising:

inserting a guide catheter into a blood vessel from a transfemoral access site, the guide catheter comprising a lumen extending between a proximal end region of the guide catheter and a distal end region of the guide catheter, the distal end region of the guide catheter having an opening from the lumen and the lumen having an inner diameter;

advancing the guide catheter toward a target site;

inserting an extension catheter into the lumen of the guide catheter positioned within the blood vessel, the extension catheter comprising;

a flexible distal luminal portion having a lumen extending between a proximal end and a distal end, wherein an outer diameter of the proximal end is larger than an outer diameter of the distal end; and

a proximal tether extending proximally from a point of attachment adjacent the proximal end of the flexible distal luminal portion, wherein an outer diameter of the proximal tether at the point of attachment is smaller than the outer diameter of the proximal end of the flexible distal luminal portion, and wherein the proximal tether is less flexible than the flexible distal luminal portion and is configured to control movement of the extension catheter;

telescopically sliding the extension catheter through the lumen of the guide catheter until the distal end of the flexible distal luminal portion of the extension catheter extends out of the opening of the guide catheter and the extension catheter reaches the target site, wherein a seal is formed between the outer diameter of the proximal end of the flexible distal luminal portion and the inner diameter of the guide catheter when the extension catheter is extended out of the opening of the guide catheter; and

removing material while applying a negative pressure to a contiguous lumen formed by the lumen of the flexible distal luminal portion and the lumen of the guide catheter when the flexible distal luminal portion of the extension catheter and the guide catheter are concentrically aligned, the contiguous lumen extending from the distal end of the flexible distal luminal portion to the proximal end region of the guide catheter.

2. The method of claim 1, wherein the proximal tether of the extension catheter is solid or hollow.

3. The method of claim 1, further comprising a step of delivering a contrast injection through the lumen of the guide catheter.

4. The method of claim 1, wherein the step of removing material while applying negative pressure comprises capturing occlusive material at, within, or through the distal end of the extension catheter.

5. The method of claim 1, wherein the step of removing material comprises inserting a retrievable device through the lumen of the extension catheter;

capturing occlusive material with the retrievable device; and

removing the occlusive material and the retrievable device from the target site.

6. The method of claim 1, wherein the flexible distal luminal portion of the extension catheter comprises a reinforcement layer of wound ribbon, wire, coil, or braid.

7. The method of claim 1, wherein a transition zone between the proximal tether and the distal luminal portion of the extension catheter is formed that bridges a flexibility of the distal luminal portion of the extension catheter and a flexibility of the proximal tether so as to avoid kinking during telescopically sliding the extension catheter.

8. The method of claim 7, wherein the proximal tether is flattened, ground down, or down-sized to be more flexible at the transition zone.

9. The method of claim 1, wherein the guide catheter has an inner diameter of about 0.086″

to about 0.088″

.

10. The method of claim 9, wherein the outer diameter of the extension catheter is about 0.083″

to about 0.086″

.

11. The method of claim 1, wherein the guide catheter is between 6F to 8F.

12. The method of claim 11, wherein the outer diameter of the flexible distal luminal portion is between about 0.083″

to about 0.086″

.

13. The method of claim 1, wherein the inner diameter of the extension catheter is about 0.070″

to about 0.095″ and

the flexible distal luminal portion has a length that is about 25 cm to about 50 cm.

14. The method of claim 1, wherein the guide catheter inserted via a transfemoral access site is advanced to a left or a right carotid artery.

15. The method of claim 14, wherein a length of the flexible distal luminal portion of the extension catheter is less than an insertable length of the guide catheter.

16. The method of claim 15, wherein the insertable length of the guide catheter is between 80 cm and 120 cm.

17. The method of claim 16, wherein the length of the flexible distal luminal portion is between 10 cm and 25 cm or between 25 cm and 50 cm.

18. The method of claim 1, wherein the seal is sufficient to transmit aspiration or pressure force to the distal end of the extension catheter.

19. The method of claim 1, wherein the seal formed between the guide catheter and the extension catheter is due to an overlap between the distal end region of the guide catheter and the proximal end of the extension catheter when the extension catheter is fully inserted through the lumen of the guide catheter.

20. The method of claim 19, wherein the overlap has a variable length such that a telescoping extension provided is variable.

21. The method of claim 19, wherein the seal formed between the guide catheter and the extension catheter is due to a difference in the outer diameter of the flexible distal luminal portion and the inner diameter of the guide catheter at the overlap region, the seal being sufficient during aspiration.

22. The method of claim 21, further comprising a sealing element at the overlap region sized to seal a gap between the outer diameter of the flexible distal luminal portion and the inner diameter of the guide catheter.

23. The method of claim 22, wherein the sealing element is positioned on an external surface of the proximal end of the distal luminal portion of the extension catheter.

24. The method of claim 22, wherein the sealing element comprises an o-ring, a quad ring, a piston seal, a wiper seal, an elastic element, or an expandable element.

25. The method of claim 22, wherein the sealing element is inflatable balloon.

26. The method of claim 22, wherein the sealing element is on an inner surface of the distal end of the guide catheter.

27. The method of claim 1, wherein the target site is located within an intracranial vessel.

28. The method of claim 27, wherein the target site is an occlusion or a region near a face of the occlusion in the intracranial vessel, and optionally wherein the intracranial vessel is a cerebral vessel located distal to a petrous portion of an internal carotid artery.

29. The method of claim 28, further comprising a hemostatic valve on the proximal end region of the guide catheter, and optionally wherein a negative pressure device is coupled to a suction port on the hemostatic valve.

30. The method of claim 29, further comprising deploying a mechanical thrombectomy device in the blood vessel and retrieving the mechanical thrombectomy device while suction is applied through the suction port, optionally comprising deploying a device to disrupt the occlusion while the mechanical thrombectomy device is deployed.