Methods and systems for establishing retrograde carotid arterial blood flow

• US 9,833,555 B2
• Filed: 09/02/2014
• Issued: 12/05/2017
• 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:
  US14/475,346
• Publication Number:
  US 20140371653A1
• Time in Patent Office: 1,190 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

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 accessing and treating a carotid artery, comprising:

percutaneously forming a transcervical access site in a neck of a patient to form an entryway through a wall of a common carotid artery, wherein the access site is located at distance of 5 cm to 7 cm below a bifurcation location where the patient'"'"'s common carotid artery bifurcates into the internal carotid artery and external carotid artery;

positioning an arterial access sheath through the entryway, wherein the arterial access sheath has a predetermined working length configured to insert into the common carotid artery, wherein the working length of the arterial access sheath is 5 cm to 15 cm;

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

aspirating blood into the sheath from the internal carotid artery.

2. A method as in claim 1, further comprising placing a distal embolic filter through the sheath and positioning the filter distal to a treatment site in an artery.

3. A method as in claim 2, further comprising:

ceasing aspiration of blood after the filter is positioned distal to the treatment site;

performing a treatment at the treatment site;

removing the filter while aspirating blood into the sheath.

4. A method as in claim 1, wherein aspirating blood comprises actively pumping blood from the arterial access sheath to a return site.

5. A method as in claim 4, wherein the return site is a venous return site.

6. A method as in claim 4, wherein the return site is an external reservoir.

7. A method as in claim 4, wherein the return site is a device that performs the aspiration.

8. A method as in claim 4, wherein the shunt is attached to a pump and wherein actively pumping comprises activating the pump to draw blood into the shunt via the sheath.

9. A method as in claim 1, wherein the aspiration device is a syringe and wherein aspirating blood comprises operating the syringe to draw blood into the shunt via the sheath.

10. A method as in claim 1, further comprising inserting a stent into a treatment site in at least one of the common carotid artery and the internal carotid artery via the arterial access sheath.

11. A method as in claim 1, further comprising adjusting a flow rate of blood aspirated into the sheath.

12. A method as in claim 1, further comprising measuring a flow rate of blood aspirated into the sheath.

13. A method as in claim 1, further comprising blocking blood flow from the common carotid artery past the sheath.

14. A method for accessing and treating a carotid artery, comprising:

percutaneously forming a transcervical access site in a neck of a patient to form an entryway through a wall of a common carotid artery, the access site located at distance 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 entryway, wherein the arterial access sheath has a working length configured to be inserted into the common carotid artery;

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

aspirating blood into the sheath from the internal carotid artery and into a shunt that extends outward from the sheath;

flowing blood from the shunt into a receptacle, the receptacle being positioned at a height;

regulating a flow rate of blood into the receptacle by varying the height of the receptacle to vary a pressure gradient between the common carotid artery and the receptacle.

15. A method as in claim 14, wherein varying the height of the receptacle comprises increasing or decreasing the height to increase a fluid pressure in the reservoir to a pressure that is greater than venous pressure.

16. A method as in claim 14, wherein varying the height of the receptacle comprises increasing or decreasing the height to reduce a fluid pressure in the reservoir to a pressure that is less than venous pressure.

17. A method as in claim 14, wherein varying the height of the receptacle comprises increasing or decreasing the height so that fluid pressure in the reservoir is different than atmospheric pressure.

18. A method as in claim 14, further comprising inserting a stent into an artery via the sheath.

19. A method as in claim 14, further comprising filtering the aspirated blood and returning the blood to the patient.

20. A method as in claim 14, further comprising adjusting a flow rate of blood aspirated into the sheath.

21. A method as in claim 14, further comprising measuring a flow rate of blood aspirated into the sheath.