IP Library Granted Patent US 9,138,527
Granted Patent B2
US 9,138,527 · App. 14/042,503 · Granted Sep 22, 2015

System and methods for controlling retrograde carotid arterial blood flow

Inventors: Richard J. Renati (Sunnyvale, CA); Michi E. Garrison (Sunnyvale, CA); Alan K. Schaer (Sunnyvale, CA); Gregory M. Hyde (Sunnyvale, CA)
Assignee: Silk Road Medical, Inc.
A61M1/3655A61B17/12009A61B17/1355A61M1/3613A61M1/3621A61M25/10A61M25/104A61B2017/00022A61F2/95
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Quick Facts
Patent No.
US 9,138,527
App. No.
14/042,503
Granted
Sep 22, 2015
Kind
B2
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 (37)

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 wherein the arterial access device includes an occlusion element adapted to occlude 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 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 wherein the arterial access device includes an occlusion element adapted to occlude the artery;

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 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.

16. A method as in claim 15 , 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.

17. A method as in claim 15 , 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.

18. A method as in claim 17 , wherein the plunger causes the retrograde flow pathway to be pinched shut.

19. A method as in claim 15 , wherein the plunger causes an internal lumen of the retrograde flow pathway to be sealed shut.

20. A method as in claim 15 , 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.

Assignments (6)
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 →
RELEASE OF SECURITY INTEREST Recorded Oct 29, 2020
From: CRG PARTNERS III L.P.; CRG PARTNERS III - PARALLEL FUND "A" L.P.; CRG PARTNERS III - PARALLEL FUND "B" (CAYMAN) L.P.; CRG PARTNERS III (CAYMAN) L.P.
To: SILK ROAD MEDICAL, INC.
Reel/Frame 054225/0451 →
SECURITY INTEREST Recorded Oct 13, 2015
From: SILK ROAD MEDICAL, INC.
To: CRG PARTNERS III L.P.; CRG PARTNERS III - PARALLEL FUND "A" L.P.; CRG PARTNERS III - PARALLEL FUND "B" (CAYMAN) L.P.; CRG PARTNERS III (CAYMAN) L.P.
Reel/Frame 036852/0347 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jan 27, 2014
From: RENATI, RICHARD J.; GARRISON, MICHI E.; SCHAER, ALAN K.; HYDE, GREGORY M.
To: SILK ROAD MEDICAL, INC.
Reel/Frame 032048/0007 →
Continuity (3)
Continuation 12793543 · Jun 3, 2010
Provisional Application 61183914 · Jun 3, 2009
Related Publication 20140031682A1 · Jan 30, 2014