Methods and systems for establishing retrograde carotid arterial blood flow

• US 9,011,364 B2
• Filed: 03/17/2011
• Issued: 04/21/2015
• 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:
  US13/050,876
• Publication Number:
  US 20110166497A1
• Time in Patent Office: 1,496 Days
• Field of Search: 604 8- 10, 604/500, 604507-509, 604/96.01, 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 system for use in accessing and treating a carotid artery, said system comprising:

an arterial access device adapted to be introduced into a common carotid artery and receive blood flow from the common carotid artery, the arterial access device including a distal sheath portion adapted to enter the common carotid artery, wherein the distal sheath portion has a distal region with a reduced luminal diameter to facilitate introduction into the common carotid artery and a proximal region having a larger luminal diameter relative to the distal region to decrease overall flow resistance through the arterial access device;

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 venous return device adapted to output blood flow wherein the venous return device is adapted to be inserted into a vein, and wherein the shunt fluidly connects the arterial access device to the venous return device such that the blood flows through the shunt from the common carotid artery to the vein.

2. A system as in claim 1, wherein the first and second blood flow state are selected from the group comprising a passive flow state, an active flow state, an aspiration state, and an off state.

3. A system as in claim 1, wherein the first blood flow state is a low flow rate and the second blood flow state is a high flow rate.

4. A system as in claim 1, wherein the flow control assembly includes a flow resistance element adapted to adjust a resistance of blood flow through the shunt.

5. A system as in claim 4, 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.

6. A system as in claim 1, wherein the flow control assembly includes a controller that controls the one or more components of the flow control assembly.

7. A system as in claim 6, wherein the controller includes at least one actuator that can be operated by a user to cause a change in the blood flow state.

8. A system as in claim 7, wherein the controller includes multiple actuators.

9. A system as in claim 8, wherein the multiple actuators include an actuator that can be operated by a user to change the blood flow state from a first blood flow rate to a second blood flow rate.

10. A system as in claim 8, wherein the multiple actuators include an actuator to cause the blood flow state to move toward a zero blood flow rate.

11. A system as in claim 7, further comprising a single housing that contains the controller and the at least one actuator.

12. A system as in claim 1, wherein the arterial access device further comprises a proximal extension which provides catheter access.

13. A system as in claim 1, wherein the venous return device comprises a distal sheath portion which enters the internal jugular vein or femoral vein.

14. A system as in claim 1, wherein the shunt is removably attached to the arterial access device.

15. A system as in claim 1, wherein the arterial access device comprises a distal sheath portion which enters the common carotid artery and an expandable occlusion member adapted to occlude the common carotid artery.

16. A system as in claim 1, further comprising a stopper member that covers the distal sheath portion such that a region of the distal sheath portion is covered by the stopper member and a region of the distal sheath portion is exposed, wherein the stopper member, when coupled to the distal sheath portion, limits insertion of the distal sheath portion into the carotid artery to the exposed portion, and wherein the stopper member is removable from the distal sheath portion.