Methods and systems for establishing retrograde carotid arterial blood flow

• US 9,789,242 B2
• Filed: 05/31/2016
• Issued: 10/17/2017
• 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:
  US15/168,809
• Publication Number:
  US 20160271316A1
• Time in Patent Office: 504 Days
• Field of Search: 604 8- 10, 606191, 606192, 623 111, 600504
• 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

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 method for treating a carotid artery, comprising:

forming penetration in a wall of a common carotid artery via a transcervical incision, the penetration being located at distance of around 5 cm to 7 cm below a bifurcation location where the patient'"'"'s common carotid artery bifurcates into an internal carotid artery and external carotid artery;

positioning an arterial access sheath through the transcervical incision and into the common carotid artery, wherein the arterial access sheath has a working length of 5 cm to 15 cm, wherein the access sheath includes an expandable element;

inserting no more than the working length of the arterial access sheath into the common carotid artery;

expanding the expandable element so that the expandable element blocks blood flow through the common carotid artery past the sheath and establish retrograde blood flow through the internal carotid artery and into the sheath, wherein blood flows into a shunt of the sheath while the common carotid artery remains blocked;

actively assisting blood flow from the common carotid artery into the sheath and into the shunt;

flowing the blood from the shunt to a return location.

2. A method as in claim 1, further comprising adjusting the flow rate of blood flow through the shut.

3. A method as in claim 2, wherein the flow rate is controlled over a range from a low rate to a high rate, where the high rate is at least three fold higher than the low rate.

4. A method as in claim 3, wherein the high rate is at least five fold higher than the low rate.

5. A method as in claim 2, wherein flow rate is controlled at a baseline low flow rate in the range from 10 ml/min to 200 ml/min during a majority of a procedure.

6. A method as in claim 2, wherein the flow rate is increased to a higher rate when there is an increased risk of emboli release.

7. A method as in claim 2, wherein the procedure comprises stenting of the internal carotid artery and the flow rate is increased during at least one of when a stent delivery catheter is introduced to the carotid artery, when the stent is deployed in the carotid artery, when the stent delivery catheter is removed from the carotid artery, or when the common carotid artery occlusion is released.

8. A method as in claim 2, wherein the flow rate is increased automatically.

9. A method as in claim 1, wherein actively assisting blood flow comprises fluidly attaching the shunt to a pump.

10. A method as in claim 1, wherein actively assisting blood flow comprises fluidly attaching the shunt to a vacuum source.