IP Library Granted Patent US 12,396,836
Granted Patent B2
US 12,396,836 · App. 18/535,698 · Granted Aug 26, 2025

Fenestrated sheath for embolic protection during transcarotid carotid artery revascularization

Inventors: Sumaira MacDonald (Sunnyvale, CA); Stewart M. Kume (Sunnyvale, CA)
Assignee: BOSTON SCIENTIFIC SCIMED, INC.
A61F2/014A61B17/12A61F2/954A61M25/0032A61M25/09A61M2025/0008A61M2025/0681A61M2025/1052
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Quick Facts
Patent No.
US 12,396,836
App. No.
18/535,698
Granted
Aug 26, 2025
Kind
B2
Abstract

Methods, devices, and systems establish and facilitate retrograde or reverse flow blood circulation in the region of the carotid artery bifurcation in order to limit or prevent the release of emboli into the cerebral vasculature such as into the internal carotid artery. The methods are particularly useful for interventional procedures, such as stenting and angioplasty, atherectomy performed through a transcarotid approach or transfemoral into the common carotid artery, either using an open surgical technique or using a percutaneous technique, such as a modified Seldinger technique or a micropuncture technique.

Claims (17)

1. A method for treating a carotid artery, comprising:

positioning an arterial access device into a common carotid artery through an access location in a neck of a patient, the arterial access device comprising:

a distal sheath having a lumen extending between a distal opening and a proximal opening;

wherein the distal sheath defines a plurality of spaces evenly distributed and uninterrupted along at least a portion of a length of the distal sheath; and

wherein the distal sheath includes at one least fenestration aligned with at least one of the spaces;

occluding blood flow at an occlusion location of the common carotid artery to establish retrograde blood flow through the common carotid artery such that blood flows into the lumen of the arterial access device, wherein the occlusion location is located proximal of the distal opening;

wherein the blood flows into the distal sheath via at least one of the distal opening and the at least one fenestration.

2. The method of claim 1 , wherein the distal sheath includes a removable stopper member that covers a portion of a distal section of the distal sheath such that a portion of the distal section of the distal sheath is covered by the stopper member and a portion of the distal section of the distal sheath is exposed, wherein the stopper member, when coupled to the distal sheath, limits insertion of the distal sheath into the carotid artery to the exposed portion, and further comprising:

inserting no more than the exposed portion of the distal sheath into the common carotid artery.

3. The method of claim 2 , wherein the at least one fenestration is located entirely within the exposed portion of the distal sheath.

4. The method of claim 1 , wherein a zone is defined adjacent to the occlusion location and wherein the zone is a static zone.

5. The method of claim 1 , wherein a zone is defined adjacent to the occlusion location and further comprising positioning the distal sheath so that at least one fenestration is positioned in the zone.

6. The method of claim 1 , wherein occluding blood flow at an occlusion location comprises applying a vascular clamp at the occlusion location.

7. The method of claim 1 , wherein occluding blood flow at an occlusion location comprises expanding a balloon at the occlusion location.

8. The method of claim 1 , further comprising making a transcervical incision to expose a region of the common carotid artery at the access location.

9. The method of claim 1 , wherein the at least one fenestration is positioned external to the common carotid artery, and further comprising blocking the at least one fenestration positioned external to the common carotid artery to prevent leakage.

10. The method of claim 1 , further comprising placing a stent in an artery via the arterial access device.

Assignments (2)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Mar 28, 2025
From: SILK ROAD MEDICAL, INC.
To: BOSTON SCIENTIFIC SCIMED, INC.
Reel/Frame 070671/0426 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Feb 16, 2024
From: MACDONALD, SUMAIRA; KUME, STEWART M.
To: SILK ROAD MEDICAL, INC.
Reel/Frame 066484/0773 →
Continuity (4)
Continuation 17470213 · Sep 9, 2021
Continuation 16171784 · Oct 26, 2018
Provisional Application 62580869 · Nov 2, 2017
Related Publication 20240341941A1 · Oct 17, 2024
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