Methods and systems for establishing retrograde carotid arterial blood flow

• US 8,157,760 B2
• Filed: 07/18/2008
• Issued: 04/17/2012
• 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): Zalukaeva, Tatyana
• Assistant Examiner(s): Wiest, Philip R
• Application Number:
  US12/176,250
• Publication Number:
  US 20090024072A1
• Time in Patent Office: 1,369 Days
• Field of Search: 604 8- 9, 604/500, 604507-509, 604/96.01, 604/101.01, 604/101.05, 604/102.02, 604/108, 606/191, 606/192, 606/194, 606/200, 623/1.11, 600/504
• US Class Current: 604/9
• 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:

forming a transcervical incision in a neck of a patient;

forming a penetration in a wall of a common carotid artery via the transcervical 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;

positioning an arterial access sheath through the transcervical incision and the penetration, wherein the arterial access sheath has a working length of 5 cm to 15 cm;

inserting no more than the working length of the arterial access sheath into the common carotid artery;

blocking blood flow from the common carotid artery past the sheath;

allowing retrograde blood flow from the internal carotid artery into the sheath and into a shunt from the sheath while the common carotid artery remains blocked; and

adjusting the state of retrograde blood flow through the shunt.

2. A method as in claim 1, wherein adjusting the state of retrograde blood flow comprises changing from a passive flow state to an active flow state.

3. A method as in claim 1, wherein adjusting the state of retrograde blood flow comprises changing the flow rate from a passive low flow state to a passive high flow state.

4. A method as in claim 3, wherein the rate is controlled over a range from a low rate to a high rate, where the high rate is at least three fold higher than the low rate.

5. A method as in claim 3, wherein the high rate is at least three fold higher than the low rate.

6. A method as in claim 3, wherein the high rate is at least five fold higher than the low rate.

7. A method as in claim 1, wherein adjusting the state of retrograde blood flow comprises changing the flow rate from a passive low flow state to an active high flow state.

8. A method as in claim 1, wherein adjusting the state of retrograde blood flow comprises changing the flow rate from a passive low flow state to a state where blood flow through the shunt is aspirated.

9. A method as in claim 1, wherein adjusting comprises adjusting flow resistance from the arterial access sheath to a return site, wherein the flow resistance within the shunt is adjusted using a flow control element attached directly to the shunt.

10. A method as in claim 9, wherein the resistance is adjusted causing blood to flow through a flow resistance element coupled to the shunt.

11. A method as in claim 1, wherein adjusting comprises actively pumping blood from the arterial access sheath to a venous return site.

12. A method as in claim 1, wherein retrograde flow is controlled at a baseline low flow rate in the range from 10 ml/min to 200 ml/min during a majority of a procedure.

13. A method as in claim 1, wherein the retrograde flow is increased to a higher rate when there is an increased risk of emboli release.

14. A method as in claim 1, wherein the procedure comprises stenting of the internal carotid artery and the flow rate is increased during at least one of when a stent delivery catheter is introduced to the carotid artery, when the stent is deployed in the carotid artery, when the stent delivery catheter is removed from the carotid artery, or when the common carotid artery occlusion is released.

15. A method as in claim 1, wherein the flow rate is increased manually by the user.

16. A method as in claim 1, wherein the flow rate is increased automatically.

17. A method as in claim 1, further comprising measuring the retrograde flow rate, wherein the continuous retrograde flow rate is controlled based on the measured flow rate.

18. A method as in claim 1, wherein the rate of retrograde flow is cycled between a lower flow rate and a higher flow rate to dislodge emboli from the common and external carotid arteries.

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

forming a penetration in a wall of a common carotid artery;

positioning an arterial access sheath through the penetration;

blocking blood flow from the common carotid artery past the sheath;

allowing retrograde blood flow from the internal carotid artery into the sheath and into a shunt from the sheath while the common carotid artery remains blocked; and

adjusting the state of retrograde blood flow through the shunt, wherein adjusting comprises adjusting flow resistance from the arterial access sheath to a return site by causing blood to flow through a flow resistance element coupled to the shunt, wherein the flow resistance element comprises two or more parallel flow paths of the shunt and a valve to open or close one or more of the flow paths to selectively direct blood flow through one or more of the flow paths.

20. A method as in claim 19, wherein the parallel flow paths include a main flow path and a secondary flow path, and wherein the secondary flow path has a higher resistance to blood flow than the main flow path.

21. A method as in claim 20, wherein the secondary flow path is longer than the main flow path.

22. A method as in claim 20, wherein the secondary flow path has a smaller diameter than the main flow path.

23. A method as in claim 20, wherein the valve is configured to block blood flow through the main flow path of the shunt such that blood flow through the shunt is diverted entirely to the secondary flow path thereby increasing the flow resistance and reducing the blood flow rate through the shunt.

24. A method as in claim 19, further comprising a controller that can be actuated by a user to control the valve.

25. A method as in claim 24, wherein the flow resistance element and the controller are integrated into a single housing.

26. A method as in claim 19, wherein retrograde flow is controlled at a baseline low flow rate in the range from 10 ml/min to 200 ml/min during a majority of a procedure.

27. A method as in claim 19, wherein the retrograde flow is increased to a higher rate when there is an increased risk of emboli release.

28. A method as in claim 19, wherein the procedure comprises stenting of the internal carotid artery and the flow rate is increased during at least one of when a stent delivery catheter is introduced to the carotid artery, when the stent is deployed in the carotid artery, when the stent delivery catheter is removed from the carotid artery, or when the common carotid artery occlusion is released.

29. A method as in claim 19, wherein the flow rate is increased manually by the user.

30. A method as in claim 19, wherein the flow rate is increased automatically.

31. A method as in claim 19, further comprising measuring the retrograde flow rate, wherein the continuous retrograde flow rate is controlled based on the measured flow rate.

32. A method as in claim 19, wherein the rate of retrograde flow is cycled between a lower flow rate and a higher flow rate to dislodge emboli from the common and external carotid arteries.

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

forming a transcervical incision in a neck of a patient;

forming a penetration in a wall of a common carotid artery;

inserting a distal section of the arterial access sheath through the transcervical incision and the penetration, wherein the arterial access sheath includes a removable 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;

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

blocking blood flow from the common carotid artery past the sheath;

allowing retrograde blood flow from the internal carotid artery into the sheath and into a shunt from the sheath while the common carotid artery remains blocked; and

adjusting the state of retrograde blood flow through the shunt using a flow control element attached directly to the shunt.