IP Library Granted Patent US 10,286,139
Granted Patent B2
US 10,286,139 · App. 16/210,533 · Granted May 14, 2019

Methods and systems for establishing retrograde carotid arterial blood flow

Inventors: Enrique Criado (Sunnyvale, CA); Tony M. Chou (San Mateo, CA); Michi E. Garrison (San Mateo, CA); Gregory M. Hyde (Sunnyvale, CA); Alan Schaer (Sunnyvale, CA); Richard Renati (Sunnyvale, CA)
Assignee: Silk Road Medical, Inc.
A61M1/3655A61B8/06A61B8/488A61B17/12045A61B17/12109A61F2/82A61F2/95A61M1/34A61M1/36A61M1/3613A61M1/3659A61M5/007A61M25/10A61M29/02A61M39/06A61M39/22A61B2017/00778A61B2017/12127A61B2017/320716A61F2/90A61F2/954A61F2002/065A61F2250/0037A61M2025/1052A61M2205/33A61M2205/3331A61M2205/3334
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Quick Facts
Patent No.
US 10,286,139
App. No.
16/210,533
Granted
May 14, 2019
Kind
B2
Abstract

Interventional procedures on the carotid arteries are performed through a transcervical access while retrograde blood flow is established from the internal carotid artery to a venous or external location. A system for use in accessing and treating a carotid artery includes an arterial access device, a shunt fluidly connected to the arterial access device, and a flow control assembly coupled to the shunt and adapted to regulate blood flow through the shunt between at least a first blood flow state and at least a second blood flow state. The flow control assembly includes one or more components that interact with the blood flow through the shunt.

Claims (25)

1. A method of treating a lesion in a carotid artery of a patient having an arterial blood system and a venous blood system, comprising:

positioning an arterial access sheath into a common carotid artery via an insertion site in the patient's neck;

blocking blood flow in at least a portion of the common carotid artery to establish retrograde blood flow through the common carotid artery such that blood flows into a lumen of the arterial access device;

shunting blood from the common carotid artery to a femoral vein of the patient via the arterial access sheath; and

treating the lesion by deploying a stent on the lesion;

wherein the arterial access sheath includes a proximal extension and a proximal hemostasis device at a proximal end of the proximal extension, and wherein the proximal extension has a length sufficient to space the hemostasis device a distance away from a insertion site such that a clinician can introduce a treatment device into the proximal extension and sheath while lessening radiation exposure to the clinician when fluoroscopy is being performed.

2. The method of claim 1 , further comprising making an incision at the insertion site to expose a region of the common carotid artery.

3. The method of claim 2 , further comprising forming a penetration in a wall of a common carotid artery via the incision, the penetration being located at distance of around 5 cm to 7 cm below a bifurcation location where the patient's common carotid artery bifurcates into an internal carotid artery and external carotid artery.

4. The method of claim 3 , wherein positioning an arterial access sheath into the common carotid artery through the incision comprises inserting a distal section of the arterial access sheath through the transcervical incision and the penetration, wherein the arterial access sheath includes a stopper member that covers a portion of the distal section of the sheath such that a portion of the distal section of the sheath is covered by the stopper member and a portion of the distal section of the sheath is exposed, wherein the stopper member, when coupled to the sheath, limits insertion of the sheath into the carotid artery to the exposed portion.

5. The method of claim 2 , further comprising forming a penetration in a wall of a common carotid artery via the incision, the penetration being located at a predetermined distance below a bifurcation location where the patient's common carotid artery bifurcates into an internal carotid artery and external carotid artery.

6. The method of claim 1 , further comprising deploying a filter in the arterial blood system at a location distal of the lesion.

7. The method of claim 1 , wherein the arterial access device comprises a working length of 5 cm to 15 cm.

8. The method of claim 1 , wherein the blood is shunted to the femoral vein of the patient through a shunt fluidly attached to the arterial access sheath.

9. The method of claim 8 , wherein the shunt includes a stopcock.

10. The method of claim 9 , wherein the shunt includes a filter.

11. The method of claim 8 , wherein the shunt has a length of 40 cm to 70 cm.

12. The method of claim 11 , wherein the shunt has an internal diameter of 4.76 mm.

13. The method of claim 12 , wherein the arterial access device comprises a working length of 5 cm to 15 cm.

14. The method of claim 8 , wherein shunt has a length and an inner diameter, and wherein a ratio of the length to the inner diameter of the shunt is in the range of 84 to 147.

15. The method of claim 1 , further comprising adjusting the state of retrograde blood flow through the shunt.

16. The method of claim 15 , wherein the state of retrograde blood flow through the shunt includes a low flow state and a high flow state.

17. The method of claim 15 , wherein the state of state of retrograde blood flow through the shunt is adjusted by actuating a flow controller attached to the shunt, wherein the flow controller is positioned at a controller location on the shunt, the controller location being spaced from the arterial access sheath by a distance that is less than half an entire length of the shunt, the distance being measured along the length of the shunt.

18. The method of claim 1 , wherein positioning an arterial access sheath into a common carotid artery via an insertion site in the patient's neck includes percutaneously accessing the common carotid artery.

19. The method of claim 18 , wherein the insertion site is located at distance of 5 cm to 7 cm below a bifurcation location where the patient's common carotid artery bifurcates into the internal carotid artery and external carotid artery.

20. The method of claim 19 , wherein the arterial access sheath has a working length of 5 cm to 15 cm.

Assignments (4)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Mar 28, 2025
From: SILK ROAD MEDICAL, INC.
To: BOSTON SCIENTIFIC SCIMED, INC.
Reel/Frame 070671/0426 →
RELEASE OF SECURITY INTEREST Recorded Sep 17, 2024
From: OXFORD FINANCE, LLC
To: SILK ROAD MEDICAL, INC.
Reel/Frame 068979/0196 →
SECURITY INTEREST Recorded Jul 11, 2023
From: SILK ROAD MEDICAL, INC.
To: OXFORD FINANCE LLC
Reel/Frame 064252/0197 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Feb 19, 2019
From: CRIADO, ENRIQUE; CHOU, TONY M.; GARRISON, MICHI E.; HYDE, GREGORY M.; SCHAER, ALAN; RENATI, RICHARD
To: SILK ROAD MEDICAL, INC.
Reel/Frame 048370/0350 →
Continuity (9)
Continuation 16008703 · Jun 14, 2018
Continuation 15728747 · Oct 10, 2017
Continuation 15168809 · May 31, 2016
Continuation 14475346 · Sep 2, 2014
Continuation 13050876 · Mar 17, 2011
Continuation 12176250 · Jul 18, 2008
Provisional Application 61026308 · Feb 5, 2008
Provisional Application 60950384 · Jul 18, 2007
Related Publication 20190105439A1 · Apr 11, 2019
Cited By (5)
US 12,194,216 US 12,194,219 US 12,296,082 US 12,396,836 US 12,661,490