Methods and systems for establishing retrograde carotid arterial blood flow

• US 10,543,307 B2
• Filed: 06/14/2018
• Issued: 01/28/2020
• Est. Priority Date: 07/18/2007
• Status: Active Grant

• Current Assignee: Silk Road Medical, Inc.
• Original Assignee: Silk Road Medical, Inc.
• Inventors: Criado, Enrique, Chou, Tony M., Garrison, Michi E., Hyde, Gregory M., Schaer, Alan, Renati, Richard
• Primary Examiner(s): Wiest, Philip R
• Application Number:
  US16/008,703
• Publication Number:
  US 20180289884A1
• Time in Patent Office: 593 Days
• CPC Class Codes: A61B 17/12045 double occlusion, e.g. during anastomosis
• CPC Class Codes: A61B 17/12109 in a blood vessel
• CPC Class Codes: A61B 2017/00778 Operations on blood vessels A61B2017/22097, A61B2017/320741 take precedence
• CPC Class Codes: A61B 2017/12127 Double occlusion, e.g. for creating blood-free anastomosis site
• CPC Class Codes: A61B 2017/320716 comprising means for preventing embolism by dislodged material
• CPC Class Codes: A61B 8/06 Measuring blood flow measuring volume flow in general G01F, e.g. G01F1/66, G01F1/72; measuring speed of fluids in general G01P5/00
• CPC Class Codes: A61B 8/488 involving Doppler signals
• CPC Class Codes: A61F 2/82 Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents stent-grafts for tubular structures of the body other than blood vessels A61F2/04; stent-grafts for blood vessels A61F2/07; instruments specially adapted for placement or removal of stents or stent-grafts A61F2/95; for closing wounds, or holding wounds closed A61B17/04 - A61B17/115; dilators A61M29/00
• CPC Class Codes: A61F 2/90 characterised by a net-like or mesh-like structure
• CPC Class Codes: A61F 2/95 Instruments specially adapted for placement or removal of stents or stent-grafts
• CPC Class Codes: A61F 2/954 for placing stents or stent-grafts in a bifurcation
• CPC Class Codes: A61F 2002/065 Y-shaped blood vessels
• CPC Class Codes: A61F 2250/0037 differing in height or in length
• CPC Class Codes: A61M 1/34 Filtering material out of the blood by passing it through a membrane, i.e. hemofiltration or diafiltration
• CPC Class Codes: A61M 1/36 Other treatment of blood in a by-pass of the natural circulatory system, e.g. temperature adaptation, irradiation ; Extra-corporeal blood circuits
• CPC Class Codes: A61M 1/3613 Reperfusion, e.g. of the coronary vessels, e.g. retroperfusion
• CPC Class Codes: A61M 1/3655 Arterio-venous shunts or fistulae
• CPC Class Codes: A61M 1/3659 Cannulae pertaining to extracorporeal circulation
• CPC Class Codes: A61M 2025/1052 for temporarily occluding a vessel for isolating a sector
• CPC Class Codes: A61M 2205/33 Controlling, regulating or measuring
• CPC Class Codes: A61M 2205/3331 : Pressure; Flow
• CPC Class Codes: A61M 2205/3334 : Measuring or controlling the flow rate
• CPC Class Codes: A61M 25/10 : Balloon catheters A61M25/0125 takes precedence; embolectomy A61B17/22032; retractors A61B17/02; inflatable balloons for placing stents or stent-grafts A61F2/958 ; stomach balloons for treatment of obesity A61F5/0003; oesophagal tubes A61J15/00
• CPC Class Codes: A61M 29/02 : Dilators made of swellable material balloon catheters for angioplasty A61M25/104
• CPC Class Codes: A61M 39/06 : Haemostasis valves, i.e. gaskets sealing around a needle, catheter or the like, closing on removal thereof
• CPC Class Codes: A61M 39/22 : Valves or arrangement of valves A61M39/02, A61M39/0247, A61M39/16 take precedence; regulating valves in infusion systems A61M5/16881; in devices worn by the patient for the reception of urine, faeces, catamenial or other discharge, or in colostomy devices A61F5/4405
• CPC Class Codes: A61M 5/007 : for contrast media
• CPC Class Codes: G11B 25/043 : using rotating discs
• CPC Class Codes: G11B 5/4846 : Constructional details of the electrical connection between arm and support

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

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.