Granted Patent B2

US 12,383,702 · App. 18/309,173 · Granted Aug 12, 2025

Inventors: Tony M. Chou (San Mateo, CA); Scott D. Wilson (San Mateo, CA); Vera Shinsky (San Mateo, CA)

Assignee: Route 92 Medical, Inc.

A61M25/0026A61B17/22A61M25/0045A61M25/005A61M25/0068A61M25/0108A61M25/0662A61M39/06A61B2017/22079A61M2025/0039A61M2025/0046A61M2025/0183A61M2039/062A61M2210/12A61M2210/127

Abstract

Claims (62)

1. A method of performing a medical procedure within a neurovasculature, the method comprising:

assembling a catheter system comprising:

an outer catheter comprising a catheter lumen having a distal opening; and a radiopaque marker near a distal end of the outer catheter; and

an inner catheter extending within the catheter lumen of the outer catheter, the inner catheter comprising:

a flexible elongate body comprising a plurality of regions, wherein one of the plurality of regions is a tapered region;

a first taper marker disposed at a distal end of the tapered region;

a second taper marker disposed at a proximal end of the tapered region and configured to identify a maximum outer diameter of the flexible elongate body; and

a proximal portion extending proximally from a proximal end of the flexible elongate body to an extracorporeal proximal end of the inner catheter;

advancing the catheter system towards a petrous portion of an internal carotid artery, the catheter system being in a tip-to-taper position comprising the distal end of the outer catheter aligned with the proximal end of the tapered region of the inner catheter;

advancing one or both of the outer catheter and the inner catheter of the catheter system within the petrous portion of the internal carotid artery;

visualizing at least the second taper marker of the inner catheter and the radiopaque marker of the outer catheter using fluoroscopy;

confirming the tip-to-taper position of the catheter system;

resuming advancing of the catheter system while in an adjusted relative position; and

positioning the catheter system until the first taper marker of the inner catheter is adjacent a proximal face of an occlusion of a treatment site and the second taper marker substantially aligns with the distal end of the outer catheter; and

advancing the outer catheter over the inner catheter so that the distal end of the outer catheter approaches the proximal face of the occlusion.

2. The method of claim 1 , further comprising withdrawing the inner catheter from the catheter lumen of the outer catheter.

3. The method of claim 2 , further comprising advancing a treatment device into the catheter lumen so that the treatment device resides at or near the treatment site.

4. The method of claim 3 , further comprising removing occlusive material while applying a negative pressure to the catheter lumen to capture the occlusive material at, within, or through the catheter lumen of the outer catheter.

5. The method of claim 4 , wherein removing occlusive material comprises:

inserting a retrievable stent device through the outer catheter;

capturing the occlusive material with the retrievable stent device; and

removing the occlusive material and the retrievable stent device from the treatment site.

6. The method of claim 2 , wherein the occlusion is in an intracranial vessel.

7. The method of claim 6 , further comprising applying aspiration to the outer catheter with an external aspiration source following withdrawing the inner catheter.

8. The method of claim 7 , wherein applying aspiration to the outer catheter is performed through a rotating hemostasis valve of an arterial access device through which the catheter system is positioned.

9. The method of claim 1 , further comprising:

introducing through an insertion site of a patient an arterial access device, the 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; and

advancing the arterial access device into the carotid artery.

10. The method of claim 9 , wherein advancing the catheter system is performed after the arterial access device is advanced into the carotid artery and further comprises:

inserting the catheter system into the internal lumen of the elongate body; and

advancing the catheter system through the internal lumen and past the distal end of the arterial access device.

11. The method of claim 10 , further comprising locking the outer catheter and the inner catheter into a fixed position relative to one another prior to advancing the catheter system.

12. The method of claim 11 , wherein locking the outer catheter and the inner catheter comprises using a mechanical locking element or gripping the outer catheter and the inner catheter by hand.

13. The method of claim 12 , wherein advancing the catheter system through the internal lumen further comprises advancing the catheter system together after the distal end of the outer catheter is advanced distal to the petrous portion of the internal carotid artery.

14. The method of claim 1 , wherein the first taper marker and/or the second taper marker is a radiopaque loaded polymer band.

15. The method of claim 1 , wherein advancing the outer catheter to the proximal face of the occlusion causes the radiopaque marker of the outer catheter to approach the first taper marker of the inner catheter.

16. A method of performing a medical procedure within a neurovasculature, the method comprising:

assembling a catheter system comprising:

an outer catheter comprising a catheter lumen having a distal opening; and a radiopaque marker near a distal end of the outer catheter; and

an inner catheter extending within the catheter lumen of the outer catheter, the inner catheter comprising:

a flexible elongate body comprising a plurality of regions, wherein one of the plurality of regions is a tapered region;

a taper marker disposed relative to the tapered region so as to identify a maximum outer diameter of the flexible elongate body; and

a proximal portion extending proximally from a proximal end of the flexible elongate body to an extracorporeal proximal end of the inner catheter;

advancing the catheter system towards a petrous portion of an internal carotid artery, the radiopaque marker near the distal end of the outer catheter being paired with the taper marker of the inner catheter;

advancing one or both of the outer catheter and the inner catheter of the catheter system within the petrous portion of the internal carotid artery,

visualizing the taper marker of the inner catheter and the radiopaque marker of the outer catheter using fluoroscopy;

confirming position of the distal end of the outer catheter to the taper marker of the inner catheter;

resuming advancing of the catheter system while in an adjusted relative position; and

positioning the catheter system until the inner catheter is adjacent a proximal face of an occlusion of a treatment site;

advancing the outer catheter over the inner catheter to the proximal face of the occlusion.

17. The method of claim 16 , wherein the radiopaque marker near the distal end of the outer catheter is at or immediately proximal to the taper marker when paired with the taper marker of the inner catheter.

18. The method of claim 16 , wherein the method further comprises withdrawing the inner catheter from the catheter lumen of the outer catheter.

19. The method of claim 18 , further comprising advancing a treatment device into the catheter lumen so that the treatment device resides at or near the treatment site.

20. The method of claim 19 , further comprising removing occlusive material while applying a negative pressure to the catheter lumen to capture the occlusive material at, within, or through the catheter lumen of the outer catheter.

21. The method of claim 20 , wherein removing occlusive material comprises:

inserting a retrievable stent device through the outer catheter;

capturing the occlusive material with the retrievable stent device; and

removing the occlusive material and the retrievable stent device from the treatment site.

22. The method of claim 18 , wherein the occlusion is in an intracranial vessel.

23. The method of claim 22 , further comprising applying aspiration to the outer catheter with an external aspiration source following withdrawing the inner catheter.

24. The method of claim 23 , wherein applying aspiration to the outer catheter is performed through a rotating hemostasis valve of an arterial access device through which the catheter system is positioned.

25. The method of claim 16 , wherein advancing the outer catheter to the proximal face of the occlusion causes the radiopaque marker of the outer catheter to approach the taper marker of the inner catheter.

Assignments (1)

Continuity (4)

References Cited (400)