IP Library › Granted Patent US 12,343,036
Granted Patent B2
US 12,343,036 · App. 19/025,636 · Granted Jul 1, 2025

Methods and systems for treatment of acute ischemic stroke

Inventors: Michi E. Garrison (San Mateo, CA); Tony M. Chou (San Mateo, CA)
Assignee: Route 92 Medical, Inc.
A61B17/3415A61B17/0218A61B17/22A61B17/221A61B17/3417A61M1/3621A61M1/82A61M25/0662A61M60/268A61M60/43A61B2017/22034A61B2017/22039A61B2017/22044A61B2017/22054A61B2017/22067A61B2017/22084A61B2017/2212A61B2017/2217A61B17/32037A61B2017/320733A61F2/013A61M2025/0681
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Quick Facts
Patent No.
US 12,343,036
App. No.
19/025,636
Granted
Jul 1, 2025
Kind
B2
Abstract

An arterial access device has an internal lumen and a proximal port, the arterial access device sized and shaped to be inserted directly into an arterial access site in the common carotid artery such that the lumen provides a passageway for an interventional device to be inserted via the proximal port into the carotid artery. The arterial access device has a distal portion that is configured to be inserted into an arterial pathway through the access site, and a proximal portion configured to extend outward from the access site when the distal portion is in the arterial pathway.

Claims (33)

1. A system of devices for performing a medical procedure at a treatment site in a cerebral vessel of a patient, the system comprising:

a catheter having a catheter lumen with an inner diameter and a distal end, the inner diameter of the catheter lumen being 0.89 mm to 2.41 mm;

an inner member comprising a distal portion sized and shaped to slide within the catheter lumen, wherein the inner member defines a single lumen having an inner diameter that is 0.51 mm to 0.61 mm, wherein the distal portion has a maximum outer diameter that decreases distally to a second outer diameter at a distal-most end of the distal portion that is smaller than the maximum outer diameter, and wherein the maximum outer diameter is sized to be positioned within and substantially corresponds to the inner diameter of the distal end of the catheter lumen, wherein the maximum outer diameter is sized so that, when the inner member extends through the catheter lumen and the distal portion is positioned distal to the distal end of the catheter lumen, the inner member forms a smooth transition from the second outer diameter to the inner diameter of the catheter lumen at the distal end and minimizes a step at the distal end; and

a guidewire sized to be positioned within the single lumen of the inner member and extend out a distal opening of the distal portion of the inner member, wherein when the guidewire is positioned to extend out of the distal opening of the distal portion of the inner member and the distal portion is positioned distal to the distal end of the catheter, the distal portion of the inner member creates a smooth transition in flexibility between a flexibility of the guidewire to a flexibility of the catheter, and

wherein the catheter and inner member are sufficiently flexible and configured to be advanced over the guidewire distal to a petrous portion of an internal carotid artery.

2. The system of claim 1 , wherein the guidewire has an outer diameter that is 0.36 mm to 0.46 mm.

3. The system of claim 1 , wherein the inner member is constructed of a material at the distal portion that is softer than a material proximal to the distal portion.

4. The system of claim 1 , wherein the catheter further comprises a flexible distal luminal portion and a proximal tether element extending proximally from a point of attachment near a proximal end of the flexible distal luminal portion, the proximal tether element extending proximally to outside the body of the patient.

5. The system of claim 4 , wherein an outer diameter of the proximal tether element at the point of attachment is smaller than an outer diameter of the distal luminal portion at the point of attachment.

6. The system of claim 4 , wherein the proximal tether element is solid or has a lumen.

7. The system of claim 4 , further comprising an arterial access device comprising an elongate body sized and shaped to be introduced into a carotid artery, the elongate body defining an internal lumen and a distal end.

8. The system of claim 7 , wherein a length of the flexible distal luminal portion is less than an insertable length of the arterial access device.

9. The system of claim 7 , further comprising a hemostasis valve positioned on a proximal end region of the arterial access device, optionally wherein a negative pressure device is coupled to a suction port on the hemostasis valve, the negative pressure device comprising a pump.

10. The system of claim 9 , wherein the pump is configured to apply aspiration forces through the internal lumen of the catheter.

11. The system of claim 1 , wherein a flexibility of the distal portion decreases proximally from the second outer diameter of the inner member.

12. The system of claim 1 , wherein a length of the distal portion has a greater flexibility than the catheter at the distal end.

13. The system of claim 12 , wherein the distal portion of the inner member tapers distally from the maximum outer diameter to the second outer diameter.

14. The system of claim 1 , wherein the inner member comprises an advancement configuration relative to the catheter forming an assembled catheter system, wherein when the inner member is positioned in the advancement configuration, the inner member forms the smooth transition and minimizes the step.

15. The system of claim 14 , wherein when the assembled catheter system is positioned with the inner member in the advancement configuration, the guidewire extends out of the distal opening of the distal portion of the inner member, the distal portion of the inner member creates a smooth transition in diameter between an outer diameter of the guidewire to the inner diameter of the catheter at the distal end.

16. The system of claim 14 , wherein the assembled catheter system is sufficiently flexible that, when positioned in the advancement configuration, the catheter and the inner member are configured to be advanced together over the guidewire distal to the petrous portion of the internal carotid artery.

17. The system of claim 1 , wherein distal portion of the inner member is sized and shaped to be withdrawn from the catheter lumen.

18. A system of devices for performing a medical procedure at a treatment site in a cerebral vessel of a patient, the system comprising:

a catheter having a distal end and a catheter lumen having an inner diameter, the inner diameter of the catheter lumen being 0.89 mm to 2.41 mm; and

an inner member comprising a distal portion sized and shaped to slide within the catheter lumen, wherein the inner member defines a single lumen having an inner diameter that is 0.51 mm to 0.61 mm, wherein the distal portion has a maximum outer diameter that decreases distally to a second outer diameter at a distal-most end that is smaller than the first outer diameter, and wherein the maximum outer diameter is sized to be positioned within and substantially corresponds to the inner diameter of the distal end of the catheter, wherein the maximum outer diameter is sized so that, when the inner member extends through the catheter lumen and the distal portion is positioned distal to the distal end of the catheter, the inner member minimizes a step at the distal end of the catheter, and

a guidewire sized to be positioned within the single lumen of the inner member and extend out a distal opening of the distal portion of the inner member, wherein when the guidewire is positioned to extend out of the distal opening of the distal portion of the inner member and the distal portion is positioned distal to the distal end of the catheter, the distal portion of the inner member creates a smooth transition in flexibility between a flexibility of the guidewire to a flexibility of the distal end of the catheter, and

wherein the catheter and inner member are sufficiently flexible and configured to be advanced over the guidewire distal to a petrous portion of an internal carotid artery.

19. The system of claim 18 , wherein an outer diameter of the guidewire is 0.36 mm to 0.46 mm.

20. The system of claim 18 , wherein a flexibility of the distal portion decreases proximally from the second outer diameter of the inner member.

21. The system of claim 20 , wherein the distal portion of the inner member tapers distally from the maximum outer diameter to the second outer diameter.

22. The system of claim 18 , wherein the inner member comprises an advancement configuration relative to the catheter forming an assembled catheter system, wherein when the inner member is positioned in the advancement configuration is forms the smooth transition.

23. The system of claim 22 , wherein when the assembled catheter system is positioned with the inner member in the advancement configuration, the guidewire extends out of the distal opening of the distal portion of the inner member, the distal portion of the inner member creates a smooth transition in diameter between an outer diameter of the guidewire to the inner diameter of the distal end of the catheter.

24. The system of claim 23 , wherein the assembled catheter system is sufficiently flexible that, when positioned in the advancement configuration, the catheter and the inner member are configured to be advanced together over the guidewire distal to the petrous portion of the internal carotid artery.

25. The system of claim 18 , wherein distal portion of the inner member is sized and shaped to be withdrawn from the catheter lumen.

Assignments (5)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jun 5, 2025
From: CHOU, TONY M.
To: ROUTE 92 MEDICAL, INC.
Reel/Frame 071535/0264 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded May 21, 2025
From: GARRISON, MICHI E.
To: SILK ROAD MEDICAL, INC.
Reel/Frame 071175/0178 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded May 21, 2025
From: SILK ROAD MEDICAL, INC.
To: NEUROCO, INC.
Reel/Frame 071175/0239 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded May 21, 2025
From: NEUROCO, INC.
To: ROUTE 92 MEDICAL, INC.
Reel/Frame 071175/0280 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded May 21, 2025
From: CHOU, TONY M.
To: ROUTE 92 MEDICAL, INC.
Reel/Frame 071337/0237 →
Continuity (8)
Continuation 17011448 · Sep 3, 2020
Continuation 13921165 · Jun 18, 2013
Continuation In Part 13566451 · Aug 3, 2012
Provisional Application 61579581 · Dec 22, 2011
Provisional Application 61547597 · Oct 14, 2011
Provisional Application 61543019 · Oct 4, 2011
Provisional Application 61515736 · Aug 5, 2011
Related Publication 20250152198A1 · May 15, 2025
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