IP Library Granted Patent US 10,543,307
Granted Patent B2
US 10,543,307 · App. 16/008,703 · Granted Jan 28, 2020

Methods and systems for establishing retrograde carotid arterial blood flow

Inventors: Enrique Criado (Sunnyvale, CA); Tony M. Chou (Sunnyvale, CA); Michi E. Garrison (Sunnyvale, 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
View Patent ↗
Loading inventors, assignments & file history…
Monitor This Case
Get email alerts when status or documents change.
Order Certified Copies
Most orders are placed with the USPTO same day — all within 24 business hours.
Order via The Patent Place →
Pre-filled with this patent's details
Quick Facts
Patent No.
US 10,543,307
App. No.
16/008,703
Granted
Jan 28, 2020
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 (95)

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

inserting an arterial access sheath into a patient's neck and through a wall of a common carotid artery at an arterial access site, wherein the arterial access sheath has a structural configuration that limits a depth of insertion of a distal portion of the arterial access sheath into the common carotid artery;

positioning a filter in an internal carotid artery distal of a location of treatment; and

inserting an interventional device into the common carotid artery via the arterial access sheath;

wherein structural configuration of the arterial access sheath limits the distal portion the from being inserted into the common carotid artery beyond a length such that the distal portion would contact a bifurcation location where the patient's common carotid artery bifurcates into an internal carotid artery and external carotid artery.

2. The method of claim 1 , wherein the arterial access site is located at distance of 5 cm to 7 cm below the bifurcation location where the patient's common carotid artery bifurcates into an internal carotid artery and external carotid artery.

3. The method of claim 2 , wherein the arterial access sheath has a working length of 5 cm to 15 cm and further comprising inserting no more than the working length of the arterial access sheath into the common carotid artery.

4. The method of claim 1 , wherein the structural configuration of the arterial access sheath includes a stopper member that at least partially covers the distal portion and that limits insertion of the distal portion into the common carotid artery.

5. The method of claim 1 , further comprising establishing reverse blood flow through the common carotid artery.

6. The method of claim 1 , further comprising blocking blood flow through at least a portion of the common carotid artery.

7. A system for use in accessing and treating a carotid artery, said system comprising:

an arterial access sheath adapted to be introduced into a common carotid artery via a neck of a patient and receive blood flow from the common carotid artery, the arterial access sheath including a distal sheath portion adapted to enter the common carotid artery, wherein the distal sheath portion has a structural configuration that limits a depth of insertion of a distal portion of the arterial access sheath into the common carotid artery; and

a filter adapted to be positioned in an internal carotid artery distal of a location of treatment;

wherein the structural configuration of the arterial access sheath limits the distal portion from being inserted into the common carotid artery beyond a length such that the distal portion would contact a bifurcation location where the patient's common carotid artery bifurcates into an internal carotid artery and external carotid artery.

8. The method of claim 7 , wherein structural configuration of the arterial access sheath limits the distal portion the from being inserted into the common carotid artery beyond a length that would disrupt plaque in the common carotid artery.

9. The system of claim 7 , wherein the arterial access sheath has a distal region with a reduced luminal diameter to facilitate introduction into the common carotid artery and a proximal region having a larger luminal diameter relative to the distal region to decrease overall flow resistance through the arterial access sheath.

10. The system of claim 7 , wherein the structural configuration comprises a stopper member that at least partially covers the distal portion and that limits insertion of the distal portion into the common carotid artery.

11. The system of claim 7 , wherein the arterial access site is located at distance of 5 cm to 7 cm below the bifurcation location where the patient's common carotid artery bifurcates into an internal carotid artery and external carotid artery.

12. The system of claim 11 , wherein the arterial access sheath has a working length of 5 cm to 15 cm and further comprising inserting no more than the working length of the arterial access sheath into the common carotid artery.

13. The system of claim 7 , further comprising:

a shunt fluidly connected to the arterial access sheath, wherein the shunt provides a pathway for blood to flow from the arterial access sheath to a return site.

14. A method for accessing and treating a carotid artery, comprising:

inserting an arterial access sheath into a patient's neck and through a wall of a common carotid artery at an arterial access site, wherein the arterial access sheath has a structural configuration that limits a depth of insertion of a distal portion of the arterial access sheath into the common carotid artery;

positioning a filter in an internal carotid artery distal of a location of treatment; and

inserting an interventional device into the common carotid artery via the arterial access sheath;

wherein structural configuration of the arterial access sheath limits the distal portion the from being inserted into the common carotid artery beyond a length that would disrupt plaque in the common carotid artery.

15. The method of claim 14 , wherein the arterial access site is located at distance of 5 cm to 7 cm below the bifurcation location where the patient's common carotid artery bifurcates into an internal carotid artery and external carotid artery.

16. The method of claim 15 , wherein the arterial access sheath has a working length of 5 cm to 15 cm and further comprising inserting no more than the working length of the arterial access sheath into the common carotid artery.

17. The method of claim 14 , wherein the structural configuration of the arterial access sheath includes a stopper member that at least partially covers the distal portion and that limits insertion of the distal portion into the common carotid artery.

18. The method of claim 14 , further comprising establishing reverse blood flow through the common carotid artery.

19. The method of claim 14 , further comprising blocking blood flow through at least a portion of the common carotid artery.

20. A system for use in accessing and treating a carotid artery, said system comprising:

an arterial access sheath adapted to be introduced into a common carotid artery via a neck of a patient and receive blood flow from the common carotid artery, the arterial access sheath including a distal sheath portion adapted to enter the common carotid artery, wherein the distal sheath portion has a structural configuration that limits a depth of insertion of a distal portion of the arterial access sheath into the common carotid artery; and

a filter adapted to be positioned in an internal carotid artery distal of a location of treatment;

wherein structural configuration of the arterial access sheath limits the distal portion the from being inserted into the common carotid artery beyond a length that would disrupt plaque in the common carotid artery.

21. The system of claim 20 , wherein the arterial access sheath has a distal region with a reduced luminal diameter to facilitate introduction into the common carotid artery and a proximal region having a larger luminal diameter relative to the distal region to decrease overall flow resistance through the arterial access sheath.

22. The system of claim 20 , wherein the structural configuration comprises a stopper member that at least partially covers the distal portion and that limits insertion of the distal portion into the common carotid artery.

23. The system of claim 20 , wherein the arterial access site is located at distance of 5 cm to 7 cm below the bifurcation location where the patient's common carotid artery bifurcates into an internal carotid artery and external carotid artery.

24. The system of claim 23 , wherein the arterial access sheath has a working length of 5 cm to 15 cm and further comprising inserting no more than the working length of the arterial access sheath into the common carotid artery.

25. The system of claim 23 , further comprising:

a shunt fluidly connected to the arterial access sheath, wherein the shunt provides a pathway for blood to flow from the arterial access sheath to a return site.

26. A system for use in accessing and treating a carotid artery, said system comprising:

an arterial access sheath adapted to be introduced into a common carotid artery via a neck of a patient and receive blood flow from the common carotid artery, the arterial access sheath including a distal sheath portion adapted to enter the common carotid artery, wherein the distal sheath portion has a structural configuration that limits a depth of insertion of a distal portion of the arterial access sheath into the common carotid artery; and

a filter adapted to be positioned in an internal carotid artery distal of a location of treatment;

wherein the arterial access sheath has a distal region with a reduced luminal diameter to facilitate introduction into the common carotid artery and a proximal region having a larger luminal diameter relative to the distal region to decrease overall flow resistance through the arterial access sheath.

27. The system of claim 26 , wherein the structural configuration comprises a stopper member that at least partially covers the distal portion and that limits insertion of the distal portion into the common carotid artery.

28. The system of claim 26 , wherein the arterial access site is located at distance of 5 cm to 7 cm below the bifurcation location where the patient's common carotid artery bifurcates into an internal carotid artery and external carotid artery.

29. The system of claim 28 , wherein the arterial access sheath has a working length of 5 cm to 15 cm and further comprising inserting no more than the working length of the arterial access sheath into the common carotid artery.

30. The system of claim 26 , further comprising:

a shunt fluidly connected to the arterial access sheath, wherein the shunt provides a pathway for blood to flow from the arterial access sheath to a return site.

31. A method for accessing and treating an artery, comprising:

inserting an arterial access sheath into a patient's neck and through a wall of a common carotid artery at an arterial access site, wherein the arterial access sheath has a structural configuration that limits a depth of insertion of a distal portion of the arterial access sheath into the common carotid artery;

positioning a filter in an internal carotid artery distal of a location of treatment; and

inserting an interventional device into the common carotid artery via the arterial access sheath;

wherein structural configuration of the arterial access sheath limits the distal portion the from being inserted into the common carotid artery beyond a length such that the distal portion would contact a bifurcation location where the patient's common carotid artery bifurcates into an internal carotid artery and external carotid artery.

32. The method of claim 31 , wherein the arterial access site is located at distance of 5 cm to 7 cm below the bifurcation location where the patient's common carotid artery bifurcates into an internal carotid artery and external carotid artery.

33. The method of claim 31 , wherein the structural configuration of the arterial access sheath includes a stopper member that at least partially covers the distal portion and that limits insertion of the distal portion into the common carotid artery.

34. The method of claim 31 , further comprising establishing reverse blood flow through at least the common carotid artery.

35. A system for use in accessing and treating an artery, said system comprising:

an arterial access sheath adapted to be introduced into a common carotid artery via a neck of a patient and receive blood flow from the common carotid artery, the arterial access sheath including a distal sheath portion adapted to enter the common carotid artery, wherein the distal sheath portion has a structural configuration that limits a depth of insertion of a distal portion of the arterial access sheath into the common carotid artery; and

a filter adapted to be positioned in an internal carotid artery distal of a location of treatment;

wherein the structural configuration of the arterial access sheath limits the distal portion from being inserted into the common carotid artery beyond a length such that the distal portion would contact a bifurcation location where the patient's common carotid artery bifurcates into an internal carotid artery and external carotid artery.

36. The method of claim 35 , wherein structural configuration of the arterial access sheath limits the distal portion the from being inserted into the common carotid artery beyond a length that would disrupt plaque in the common carotid artery.

37. The system of claim 35 , wherein the arterial access sheath has a distal region with a reduced luminal diameter to facilitate introduction into the common carotid artery and a proximal region having a larger luminal diameter relative to the distal region to decrease overall flow resistance through the arterial access sheath.

38. The system of claim 35 , wherein the structural configuration comprises a stopper member that at least partially covers the distal portion and that limits insertion of the distal portion into the common carotid artery.

39. The system of claim 35 , further comprising:

a shunt fluidly connected to the arterial access sheath, wherein the shunt provides a pathway for blood to flow from the arterial access sheath to a return site.

40. A method for accessing and treating an artery, comprising:

inserting an arterial access sheath into a patient's neck and through a wall of a common carotid artery at an arterial access site, wherein the arterial access sheath has a structural configuration that limits a depth of insertion of a distal portion of the arterial access sheath into the common carotid artery;

positioning a filter in an internal carotid artery distal of a location of treatment; and

inserting an interventional device into the common carotid artery via the arterial access sheath;

wherein structural configuration of the arterial access sheath limits the distal portion the from being inserted into the common carotid artery beyond a length that would disrupt plaque in an artery.

41. The method of claim 40 , wherein the arterial access site is located at distance of 5 cm to 7 cm below the bifurcation location where the patient's common carotid artery bifurcates into an internal carotid artery and external carotid artery.

42. The method of claim 41 , wherein the arterial access sheath has a working length of 5 cm to 15 cm and further comprising inserting no more than the working length of the arterial access sheath into the common carotid artery.

43. The method of claim 40 , wherein the structural configuration of the arterial access sheath includes a stopper member that at least partially covers the distal portion and that limits insertion of the distal portion into the common carotid artery.

44. The method of claim 40 , further comprising establishing reverse blood flow through at least the common carotid artery.

45. The method of claim 40 , further comprising blocking blood flow through at least a portion of the common carotid artery.

46. A system for use in accessing and treating an artery, said system comprising:

an arterial access sheath adapted to be introduced into a common carotid artery via a neck of a patient and receive blood flow from the common carotid artery, the arterial access sheath including a distal sheath portion adapted to enter the common carotid artery, wherein the distal sheath portion has a structural configuration that limits a depth of insertion of a distal portion of the arterial access sheath into the common carotid artery; and

a filter adapted to be positioned in an internal carotid artery distal of a location of treatment;

wherein structural configuration of the arterial access sheath limits the distal portion the from being inserted into the common carotid artery beyond a length that would disrupt plaque in the common carotid artery.

47. The system of claim 46 , wherein the arterial access sheath has a distal region with a reduced luminal diameter to facilitate introduction into the common carotid artery and a proximal region having a larger luminal diameter relative to the distal region to decrease overall flow resistance through the arterial access sheath.

48. The system of claim 46 , wherein the structural configuration comprises a stopper member that at least partially covers the distal portion and that limits insertion of the distal portion into the common carotid artery.

49. The system of claim 46 , wherein the arterial access site is located at distance of 5 cm to 7 cm below the bifurcation location where the patient's common carotid artery bifurcates into an internal carotid artery and external carotid artery.

50. The system of claim 46 , further comprising:

a shunt fluidly connected to the arterial access sheath, wherein the shunt provides a pathway for blood to flow from the arterial access sheath to a return site.

51. A system for use in accessing and treating an artery, said system comprising:

an arterial access sheath adapted to be introduced into a common carotid artery via a neck of a patient and receive blood flow from the common carotid artery, the arterial access sheath including a distal sheath portion adapted to enter the common carotid artery, wherein the distal sheath portion has a structural configuration that limits a depth of insertion of a distal portion of the arterial access sheath into the common carotid artery; and

a filter adapted to be positioned in an internal carotid artery distal of a location of treatment;

wherein the arterial access sheath has a distal region with a reduced luminal diameter to facilitate introduction into the common carotid artery and a proximal region having a larger luminal diameter relative to the distal region to decrease overall flow resistance through the arterial access sheath.

52. The system of claim 51 , wherein the structural configuration comprises a stopper member that at least partially covers the distal portion and that limits insertion of the distal portion into the common carotid artery.

53. The system of claim 51 , wherein the arterial access site is located at distance of 5 cm to 7 cm below the bifurcation location where the patient's common carotid artery bifurcates into an internal carotid artery and external carotid artery.

54. The system of claim 53 , wherein the arterial access sheath has a working length of 5 cm to 15 cm and further comprising inserting no more than the working length of the arterial access sheath into the common carotid artery.

55. The system of claim 51 , further comprising:

a shunt fluidly connected to the arterial access sheath, wherein the shunt provides a pathway for blood to flow from the arterial access sheath to a return site.

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 (8)
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 20180289884A1 · Oct 11, 2018
Cited By (1)
US 12,661,490