METHODS AND SYSTEMS FOR ESTABLISHING RETROGRADE CAROTID ARTERIAL BLOOD FLOW

• US 20100280431A1
• Filed: 07/13/2010
• Published: 11/04/2010
• Est. Priority Date: 07/18/2007
• Status: Active Grant

• Current Assignee: Silk Road Medical, Inc.
• Original Assignee: Silk Road Medical, Inc.
• Inventors: Garrison, Michi E., Hyde, Gregory M., Schaer, Alan, Renati, Richard, Chou, Tony M., Criado, Enrique
• Granted Patent: US 8,784,355 B2
• Time in Patent Office: Days
• 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 system for use in accessing and treating a carotid, said system comprising:

an arterial access device adapted to be introduced into a common carotid artery and receive blood flow from the carotid artery;

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

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, wherein the flow control assembly includes one or more components that interact with the blood flow through the shunt; and

a one-way valve coupled to the shunt, wherein the valve prevents fluid flow through the shunt in a direction towards the arterial access device.

2. A system as in claim 1, further comprising a port fluidly communicating with the shunt, wherein the port may be used to connect an aspiration device to the shunt.

3. A system as in claim 2, further comprising a valve which controls fluid communication between the shunt and the port.

4. A system as in claim 3, wherein the valve automatically opens with attachment of an aspiration or injection device, and wherein the valve automatically closes with removal of the aspiration or injection device.

5. A system as in claim 2, wherein the aspiration device is a syringe, a vacuum-lock syringe, a vacuum syringe, a suction pump, or other aspiration source.

6. A system as in claim 1, further comprising:

a fluid line communicating with the shunt, and wherein the fluid line may be used to connect an injection or aspiration device to the shunt line.

7. A system as in claim 6, wherein a connection of the fluid line to the shunt is contained within a housing of the flow control assembly

8. A system as in claim 6, wherein a connection of the fluid line to the shunt is outside a housing of the flow control assembly.

9. A system as in claim 6, wherein flow control assembly contains an actuator adapted to open communication between the fluid line and the shunt.

10. A system as in claim 9, wherein the actuator can be manually actuated by a user to both open and close a connection between the fluid line and the shunt.

11. A system as in claim 9, wherein the actuator closes the shunt line towards the return site when the actuator opens the connection between the fluid line and the shunt.

12. A system as in claim 9, wherein the actuator automatically reverts to close the fluid line connection and open the shunt connection to the return site when the aspiration is complete.

13. A system as in claim 1, wherein the shunt further comprises an active pump comprising active pump controls.

14. A system as in claim 13, wherein the active pump controls are coupled to a housing of the flow control assembly.

15. A system as in claim 13, wherein the active pump controls are separate from a housing of the flow control assembly.

16. A system as in claim 13, wherein the active pump fluid pathway is in parallel to a passive flow control fluid pathway.

17. A system as in claim 13, wherein the flow control assembly 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 adjust the state of flow by selectively direct blood flow through one or more of the flow paths, and wherein the active pump is attached to one of the parallel flow paths.

18. A system as in claim 13, wherein the active pump fluid path is coupled in series to the passive flow control fluid pathway.

19. A system as in claim 18, wherein the active pump allows passive flow when the active pump is inactive.

20. A system as in claim 13, wherein the active pump is a roller pump, a positive displacement pump, a syringe pump, or an impeller pump.

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

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

positioning an arterial access sheath through the penetration;

connecting a flow shunt from the arterial access sheath to a return site, wherein the flow shunt is coupled to a one way valve that permits fluid flow through the shunt in a direction towards a return site;

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

allowing retrograde blood flow from the internal carotid artery via the sheath and the shunt to the return site while the common carotid artery remains blocked; and

adjusting the state of retrograde blood flow through the sheath and shunt.

22. A method as in claim 21, further comprising attaching an aspiration device to the flow shunt and aspirating fluid from the shunt.

23. A method as in claim 22, wherein the aspiration device comprises a discreet vacuum source, and wherein aspirating from the shunt comprises opening a valve between the shunt and the vacuum source.

24. A device for use in accessing and treating a carotid or cerebral artery, said device comprising:

a sheath having a distal portion, a proximal portion, and a lumen extending between the distal and proximal portion, wherein the sheath is stepped or tapered such that the diameter of the sheath at the proximal portion is greater than the diameter of the sheath at the distal portion;

a hemostasis valve at a proximal region of the sheath, the hemostasis valve being adapted to inhibit blood flow from the sheath while allowing device introduction into the sheath; and

an inflatable occlusion member at the distal region of the sheath.

25. A device as in claim 24, wherein the distal portion is adapted to be inserted into the common carotid artery, and wherein the inflatable occlusion member is adapted to occlude the common carotid artery.

26. A device as in claim 25, wherein the distal portion has an inner diameter in the range from about 0.110 inch to 0.135 inch.

27. A device as in claim 25, wherein the distal portion has a length from about 2 to 4 cm.

28. A device as in claim 24, further comprising a flow line having a lumen fluidly connected to the sheath, the flow line connected near the proximal end of the sheath so that blood can flow from the sheath into the flow line.

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

an arterial access device adapted to be introduced into a common carotid artery and receive blood flow from the carotid artery, wherein the arterial access device comprises a sheath having a stepped or tapered diameter such that the diameter at the proximal end of the sheath is greater than the diameter at the distal end of the sheath;

a shunt fluidly connected to the arterial access device, wherein the shunt provides a pathway for blood to flow from the arterial access device to a return site; 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, wherein the flow control assembly includes one or more components that interact with the blood flow through the shunt.

30. A system as in claim 29, further comprising an inflatable occlusion member on a distal region of the sheath.

31. A system as in claim 29, wherein the distal end of the sheath is adapted to be inserted into the common carotid artery, and wherein the inflatable occlusion member is adapted to occlude the common carotid artery.

32. A system as in claim 29, wherein the distal end of the sheath is adapted to be inserted into the internal carotid artery and the proximal end is adapted to be inserted into the common carotid artery, and wherein the occlusion member is adapted to occlude the internal carotid artery.

33. 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 having a distal end and an inflatable occlusion member through the penetration, wherein the distal end of the sheath is adapted to be inserted into the common carotid artery, and wherein the inflatable occlusion member is adapted to occlude the common carotid artery;

placing a distal embolic protection device through the arterial access sheath into the internal carotid artery distal to a treatment site; and

performing a procedure on the carotid artery.

34. A method as in claim 33, wherein the distal embolic protection device is a distal filter.

35. 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 carotid artery into the sheath through a flow path;

placing a distal embolic protection device through the arterial access sheath into the internal carotid artery distal to a treatment site;

unblocking blood flow from the common carotid artery past the sheath and closing the flow path to restore antegrade flow to the internal carotid artery; and

performing a procedure on the carotid artery.

36. The method as in claim 35, further comprising the steps of:

re-blocking the blood flow from the common carotid artery and reestablishing retrograde blood flow in the internal carotid artery; and

removing the distal embolic protection device.

37. The method as in claim 35, wherein performing a procedure comprises placing a stent.

38. 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;

aspirating from the arterial access sheath to create retrograde blood flow from the carotid artery while the common carotid artery remains blocked;

placing a distal embolic protection device during the aspiration step through the arterial access sheath into the internal carotid artery distal to a treatment site;

unblocking blood flow from the common carotid artery past the sheath to restore antegrade flow to the internal carotid artery; and

performing a procedure on the carotid artery.

39. The method as in claim 38, further comprising the steps of:

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

aspirating from the arterial access sheath while removing the distal embolic protection device.

40. The method as in claim 38, wherein performing a procedure comprises placing a stent.