Methods and systems for establishing retrograde carotid arterial blood flow

Patent metadata

Field	Value
Publication number	US-10286139-B2
Application number	US-201816210533-A
Country	US
Kind code	B2
Filing date	Dec 5, 2018
Priority date	Jul 18, 2007
Publication date	May 14, 2019
Grant date	May 14, 2019

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.

First claim

What is claimed is:

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;
blocking blood flow in at least a portion of the common carotid artery to establish 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;
wherein the arterial access sheath includes a proximal extension and a proximal hemostasis device at a proximal end of the proximal extension, and wherein the proximal extension has a length sufficient to space the hemostasis device a distance away from a insertion site such that a clinician can introduce a treatment device into the proximal extension and sheath while lessening radiation exposure to the clinician when fluoroscopy is being performed.

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 transcervical 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 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.

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

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

8. 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.

9. The method of claim 8 , wherein the shunt includes a stopcock.

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

11. The method of claim 8 , 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 8 , wherein shunt has a length and an inner diameter, and wherein a ratio of the length to the inner diameter of the shunt is in the range of 84 to 147.

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

16. The method of claim 15 , wherein the state of retrograde blood flow through the shunt includes a low flow state and a high flow state.

17. The method of claim 15 , 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. The method of claim 18 , wherein the insertion 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.

20. The method of claim 19 , wherein the arterial access sheath has a working length of 5 cm to 15 cm.

Assignees

• Silk Road Medical Inc

Inventors

• Criado Enrique
• Chou Tony M
• Garrison Michi E
• Hyde Gregory M
• Schaer Alan
• Renati Richard

Classifications

• A61M2025/1052

  for temporarily occluding a vessel for isolating a sector · CPC title

• A61B2017/00778

  Operations on blood vessels (A61B2017/22097, A61B2017/320741 take precedence) · CPC title

• A61B2017/12127

  Double occlusion, e.g. for creating blood-free anastomosis site · CPC title

• A61F2/82

  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) · CPC title

• A61M25/10

  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 title