Methods and systems for establishing retrograde carotid arterial blood flow

• US 10,485,917 B2
• Filed: 05/13/2019
• Issued: 11/26/2019
• 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:
  US16/410,485
• Publication Number:
  US 20190262530A1
• Time in Patent Office: 197 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 method of treating a lesion in a carotid artery of a patient having an arterial blood system and a venous blood system, comprising:

positioning an arterial access sheath into a common carotid artery via an insertion site in the patient'"'"'s neck wherein the arterial access sheath is coupled to a hemostasis device located a distance from the insertion site such that radiation exposure to the hemostasis device is reduced relative to radiation exposure at the insertion site when fluoroscopy is being performed at the insertion site;

establishing retrograde blood flow through the common carotid artery such that blood flows into a lumen of the arterial access device;

shunting blood from the common carotid artery to a femoral vein of the patient via the arterial access sheath; and

treating the lesion by deploying a stent on the lesion.

2. The method of claim 1, further comprising making an incision at the insertion site to expose a region of the common carotid artery.

3. The method of claim 2, further comprising forming a penetration in a wall of a common carotid artery via the 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.

4. The method of claim 3, wherein positioning an arterial access sheath into the common carotid artery through the incision comprises inserting a distal section of the arterial access sheath through the incision and the penetration, wherein the arterial access sheath includes a stopper member that covers a portion of the distal section of the sheath such that a portion of the distal section of the sheath is covered by the stopper member and a portion of the distal section of the sheath is exposed, wherein the stopper member, when coupled to the sheath, limits insertion of the sheath into the carotid artery to the exposed portion.

5. The method of claim 3, wherein the hemostasis device is directly attached to the arterial access sheath.

6. The method of claim 2, further comprising forming a penetration in a wall of a common carotid artery via the incision, the penetration being located at a predetermined distance below a bifurcation location where the patient'"'"'s common carotid artery bifurcates into an internal carotid artery and external carotid artery.

7. The method of claim 1, further comprising deploying a filter in the arterial blood system at a location distal of the lesion.

8. The method of claim 1, wherein the arterial access device comprises a working length of 5 cm to 15 cm.

9. The method of claim 1, wherein the blood is shunted to the femoral vein of the patient through a shunt fluidly attached to the arterial access sheath.

10. The method of claim 9, wherein the shunt includes a filter.

11. The method of claim 9, wherein the shunt has a length of 40 cm to 70 cm.

12. The method of claim 11, wherein the shunt has an internal diameter of 4.76 mm.

13. The method of claim 12, wherein the arterial access device comprises a working length of 5 cm to 15 cm.

14. The method of claim 1, further comprising blocking blood flow in at least a portion of the common carotid artery.

15. The method of claim 1, wherein hemostasis valve is attached to a distal end of the arterial access sheath.

16. The method of claim 1, further comprising adjusting the state of retrograde blood flow through the shunt.

17. The method of claim 16, wherein the state of state of retrograde blood flow through the shunt is adjusted by actuating a flow controller attached to the shunt, wherein the flow controller is positioned at a controller location on the shunt, the controller location being spaced from the arterial access sheath by a distance that is less than half an entire length of the shunt, the distance being measured along the length of the shunt.

18. The method of claim 1, wherein positioning an arterial access sheath into a common carotid artery via an insertion site in the patient'"'"'s neck includes percutaneously accessing the common carotid artery.

19. A method of treating a lesion in a carotid artery of a patient having an arterial blood system and a venous blood system, comprising:

positioning an arterial access sheath into a common carotid artery via an insertion site in the patient'"'"'s neck wherein the arterial access sheath is coupled to a hemostasis device located a distance from the insertion site such that a radiation level at the hemostasis device is less than a radiation level at the insertion site when fluoroscopy is being performed at the insertion site;

reducing blood flow in at least a portion of the common carotid artery to establish retrograde blood flow through at least a portion of the common carotid artery such that blood flows from the common carotid artery into a lumen of the arterial access sheath;

shunting blood from the carotid artery to a femoral vein of the patient via the arterial access sheath; and

treating the lesion by deploying a stent on the lesion.

20. The method of claim 19, further comprising accessing the femoral vein via a percutaneous puncture.

21. The method of claim 19, further comprising inserting a treatment device through the hemostasis device.

22. The method of claim 19, further comprising making an incision at the insertion site to expose a region of the common carotid artery.

23. The method of claim 19, further comprising deploying a filter in the arterial blood system at a location distal of the lesion.

24. The method of claim 19, wherein positioning an arterial access sheath into a common carotid artery via an insertion site in the patient'"'"'s neck includes percutaneously accessing the common carotid artery.

25. A method of treating a lesion in a carotid artery of a patient having an arterial blood system and a venous blood system, comprising:

positioning an arterial access sheath into a common carotid artery via an insertion site in the patient'"'"'s neck wherein the arterial access sheath is coupled to a hemostasis device located a distance from the insertion site such that a radiation level at the hemostasis device is less than a radiation level at the insertion site when fluoroscopy is being performed at the insertion site;

treating the lesion by deploying a stent on the lesion.

26. The method of claim 25, further comprising reducing blood flow in at least a portion of the common carotid artery to establish retrograde blood flow through at least a portion of the common carotid artery such that blood flows from the common carotid artery into a lumen of the arterial access sheath;

shunting blood from the carotid artery to a femoral vein of the patient via the arterial access sheath.

27. The method of claim 25, further comprising making an incision at the insertion site to expose a region of the common carotid artery.