System and methods for controlling retrograde carotid arterial blood flow

• US 8,545,432 B2
• Filed: 06/03/2010
• Issued: 10/01/2013
• Est. Priority Date: 06/03/2009
• Status: Active Grant

• Current Assignee: Silk Road Medical, Inc.
• Original Assignee: Silk Road Medical, Inc.
• Inventors: Renati, Richard J., Garrison, Michi E., Schaer, Alan K., Hyde, Gregory M.
• Primary Examiner(s): Wiest, Philip R
• Application Number:
  US12/793,543
• Publication Number:
  US 20110004147A1
• Time in Patent Office: 1,216 Days
• Field of Search: 604 401- 616, 604 8- 10, 604/504, 604/509, 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 17/12009 Implements for ligaturing other than by clamps or clips, e.g. using a loop with a slip knot
• CPC Class Codes: A61B 17/1355 Automated control means therefor
• CPC Class Codes: A61B 2017/00022 Sensing or detecting at the treatment site
• CPC Class Codes: A61F 2/95 Instruments specially adapted for placement or removal of stents or stent-grafts
• CPC Class Codes: A61M 1/3613 Reperfusion, e.g. of the coronary vessels, e.g. retroperfusion
• CPC Class Codes: A61M 1/3621 Extra-corporeal blood circuits single-needle circuits A61M1/30
• CPC Class Codes: A61M 1/3655 Arterio-venous shunts or fistulae
• 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 25/104 used for angioplasty

Abstract

A retrograde flow system is configured for treating an artery. The system includes an arterial access device adapted to be introduced into an artery and receive blood flow from the artery. A shunt fluidly is 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 is coupled to the shunt and is adapted to regulate blood flow through the shunt between at least a first blood flow state and at least a second blood flow state. A shut-off valve assembly automatically blocks fluid flow through the shunt in response to injection of the fluid into the arterial access device.

Claims

1. A retrograde flow system for treating an artery, comprising:

an arterial access device adapted to be introduced into an artery and receive blood flow from the 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 a flow resistance element adapted to adjust a resistance of blood flow through the shunt, and 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 direct blood flow selectively through one or more of the flow paths, and wherein the parallel flow paths include a main flow path and a secondary flow path that has a higher resistance to blood flow than the main flow path; and

a shut-off valve assembly that regulates fluid flow through the shunt, wherein the shut-off valve assembly automatically blocks fluid flow through the shunt in response to injection of a fluid into the arterial access device.

2. A system as in claim 1, further comprising a fluid line that communicates with the shut-off valve assembly and the arterial access device, wherein the fluid line provides a pathway for injecting fluid into the arterial access device, and wherein the fluid line communicates an injection pressure to the shut-off valve assembly.

3. A system as in claim 2, wherein the flow control assembly comprises a single housing through which at least a portion of the shunt and a portion of the fluid line pass through.

4. A system as in claim 1, wherein the shut-off valve assembly includes:

a pressure sensor that senses an injection pressure of the fluid;

a solenoid that communicates with the pressure sensor and the shut-off valve assembly, wherein the solenoid causes the shut-off valve assembly to block fluid flow through the shunt in response to detection of a predetermined injection pressure.

5. A system as in claim 1, wherein the fluid is contrast fluid.

6. A system as in claim 1, wherein the shut-off valve assembly includes:

a plunger that moves between a closed position wherein the plunger prevents fluid flow through the shunt, and an open position wherein the plunger does not prevent fluid flow through the shunt, and wherein the plunger moves to the closed position in response to injection of the fluid into the arterial access device.

7. A system as in claim 6, wherein the plunger is in the open position in a default state.

8. A system as in claim 6, wherein, when in the closed position, the plunger pushes a blocking member toward a thin-walled portion of the shunt such that the blocking member pinches the shunt and prevents fluid flow through the shunt.

9. A system as in claim 6, wherein, when in the closed position, the plunger pushes a seal member into an internal lumen of the shunt such that the seal member seals the internal lumen of the shunt and prevents fluid flow through the shunt.

10. A system as in claim 1, wherein the shut-off assembly includes:

a chamber that is in contact with at least a portion of the shunt, wherein pressure within the chamber increases in response to injection of the fluid into the arterial access device, and wherein the pressure increase causes the portion of the shunt to collapse thereby preventing fluid flow through the portion of the shunt.

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

a fluid line that communicates with the shut-off valve assembly and the arterial access device; and

an aspiration actuator that, when actuated, permits aspiration of the arterial access device via the fluid line.

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

a fluid line that communicates with the shut-off valve assembly and the arterial access device and through which the fluid flows, wherein the fluid line includes a first leg and a second leg, and wherein a plunger chamber is positioned between the first leg and the second leg, and wherein a plunger is movably positioned in the plunger chamber to prevent or permit fluid communication between the first leg and the second leg, and wherein a position of the plunger varies in response to injection of the fluid into the arterial access device.

13. A system as in claim 12, wherein the fluid line further includes a bypass region that fluidly connects the first leg to the second leg regardless of the position of the plunger in the chamber, and wherein a one-way valve is positioned in the bypass region.

14. A system as in claim 1, further comprising a one-way valve in the shunt, wherein the one-way valve prevents fluid flow through the shunt in a predetermined direction.

15. A method as in claim 1, wherein the shut off valve assembly includes a bypass that bypasses a portion of the fluid line, and further comprising:

aspirating fluid from the carotid artery through the bypass of the fluid line via an aspiration device connected to the fluid line, while ceasing injection of the fluid into the carotid artery.

16. A system as in claim 1, wherein the secondary flow path is longer than the main flow path.

17. A system as in claim 1, wherein the secondary flow path has a smaller diameter than the main flow path.

18. A system as in claim 1, 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.

19. A method for accessing and treating the carotid or cerebral artery, comprising:

forming a penetration in a wall of a carotid artery;

positioning an access sheath through the penetration;

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

allowing retrograde blood flow along a retrograde flow pathway from the carotid artery into the sheath and from the sheath via a flow path to a return site;

adjusting the state of retrograde blood flow through the flow path, 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 flow path, wherein the flow resistance element comprises two or more parallel flow paths of the flow path 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; and

injecting a fluid into the carotid artery via the access sheath, wherein injection of the fluid automatically causes flow to be blocked through the retrograde flow pathway.

20. A method as in claim 19, wherein the fluid is injected into the carotid artery using a user'"'"'s first hand without requiring a user to use a second hand to block flow through the retrograde flow pathway.

21. A method as in claim 19, wherein the injection of the fluid automatically causes a plunger to move toward the retrograde flow pathway so as to block flow through the retrograde flow pathway.

22. A method as in claim 21, wherein the plunger causes the retrograde flow pathway to be pinched shut.

23. A method as in claim 19, wherein the plunger causes an internal lumen of the retrograde flow pathway to be sealed shut.

24. A method as in claim 19, wherein the fluid is injected into the carotid artery through a fluid line fluidly connected to the arterial sheath, and wherein a shut-off valve assembly positioned along the fluid line blocks flow through the retrograde flow pathway when fluid is injected into the carotid artery.

25. A method as in claim 24, wherein the bypass includes a one-way valve that prevents fluid from flowing through the bypass during injection of fluid into the fluid line.

26. 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.

27. A method as in claim 19, wherein the secondary flow path is longer than the main flow path.

28. A method as in claim 19, wherein the secondary flow path has a smaller diameter than the main flow path.