Methods and systems for establishing retrograde carotid arterial blood flow

• US 10,709,832 B2
• Filed: 09/24/2019
• Issued: 07/14/2020
• 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:
  US16/581,061
• Publication Number:
  US 20200016321A1
• Time in Patent Office: 294 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 system for use in accessing and treating a target artery, said system comprising:

an arterial access device adapted to be introduced into a common carotid artery and receive blood flow from the target 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; 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, wherein the flow control assembly comprises two or more parallel flow paths and a valve to open or close one or more of the flow paths to adjust the state of flow by selectively directing blood flow through one or more of the flow paths.

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 second valve which controls fluid communication between the shunt and the port.

4. A system as in claim 3, wherein the second valve automatically opens with attachment of an aspiration or injection device, and wherein the second 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 the 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, further comprising an active pump coupled to the shunt.

14. A system as in claim 13, wherein the active pump allows passive flow when the active pump is inactive.

15. 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.

16. A system as in claim 1, further comprising 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.

17. A system for use in accessing and treating a target artery, said system comprising:

an arterial access device adapted to be introduced into a common carotid artery and receive blood flow from the target 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, wherein the flow control assembly comprises two or more parallel flow paths and a valve to open or close one or more of the flow paths to adjust the state of flow b selectively directing blood flow through one or more of the flow paths; and

a filter coupled to the shunt, wherein the filter filters fluid flow through the shunt.

18. A system as in claim 17, further comprising a port fluidly communicating with the shunt, wherein the port may be used to connect an aspiration device to the shunt.

19. A system as in claim 17, further comprising a second valve that controls fluid communication between the shunt and the port.

20. A system as in claim 19, wherein the second valve automatically opens with attachment of an aspiration or injection device, and wherein the second valve automatically closes with removal of the aspiration or injection device.

21. A system as in claim 18, wherein the aspiration or injection device is a syringe, a vacuum-lock syringe, a vacuum syringe, a suction pump, or other aspiration source.

22. A system as in claim 17, 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.

23. A system as in claim 22, wherein a connection of the fluid line to the shunt is contained within a housing of the flow control assembly.

24. A system as in claim 22, wherein a connection of the fluid line to the shunt is outside a housing of the flow control assembly.

25. A system as in claim 22, wherein the flow control assembly contains an actuator adapted to open communication between the fluid line and the shunt.

26. A system as in claim 25, wherein the actuator closes the shunt line towards the return site when the actuator opens the connection between the fluid line and the shunt.

27. A system as in claim 25, 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.

28. A system as in claim 17, further comprising an active pump coupled to the shunt.

29. A system as in claim 17, wherein the active pump controls are separate from a housing of the flow control assembly.

30. A system as in claim 29, wherein the active pump allows passive flow when the active pump is inactive.