METHODS AND SYSTEMS FOR ESTABLISHING RETROGRADE CAROTID ARTERIAL BLOOD FLOW

• US 20160296690A1
• Filed: 04/07/2016
• Published: 10/13/2016
• Est. Priority Date: 04/10/2015
• Status: Active Grant

• Current Assignee: Silk Road Medical, Inc.
• Original Assignee: Silk Road Medical, Inc.
• Inventors: Duong, Sieu T., Kume, Stewart M., Garrison, Michi E.
• Granted Patent: US 10,238,853 B2
• Time in Patent Office: Days
• US Class Current: 1/1
• CPC Class Codes: A61M 1/3613 Reperfusion, e.g. of the coronary vessels, e.g. retroperfusion
• CPC Class Codes: A61M 1/3653 Interfaces between patient blood circulation and extra-corporal blood circuit
• CPC Class Codes: A61M 1/3656 Monitoring patency or flow at connection sites; Detecting disconnections
• CPC Class Codes: A61M 1/3659 Cannulae pertaining to extracorporeal circulation
• CPC Class Codes: A61M 2205/3334 Measuring or controlling the flow rate
• CPC Class Codes: A61M 2205/7545 for solid matter, e.g. microaggregates
• 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 39/06 Haemostasis valves, i.e. gaskets sealing around a needle, catheter or the like, closing on removal thereof
• CPC Class Codes: A61M 39/223 Multiway valves

Abstract

Devices and methods establish and facilitate retrograde or reverse flow blood circulation in the region of the carotid artery bifurcation in order to limit or prevent the release of emboli into the cerebral vasculature such as into the internal carotid artery. The methods are particularly useful for interventional procedures performed through a transcarotid approach or transfemoral into the common carotid artery.

Claims

1. A transcarotid access device, comprising:

an arterial access sheath having a sheath body defining an internal lumen, the sheath body sized and shaped to be introduced into an opening in a common carotid artery and receive blood flow from the carotid artery;

an elongated tubing attached to a proximal end of the sheath body, wherein a connector connects the tubing to the sheath body;

an adapter at a proximal end of the elongated tubing, the adapter having a hub adapted to be removably connected to a flow shunt line, the adapter further having a valve positioned immediately adjacent to an internal lumen of the transcarotid access device, wherein the valve regulates fluid flow out of the internal lumen of the transcarotid access device toward the hub;

a proximal extension connected to a proximal end of the adapter, the proximal extension formed of an elongated body;

a hemostasis valve at a proximal end of the proximal extension such that the proximal extension spaces apart the hemostasis valve from the adapter; and

a flush line connected to a proximal end of the proximal extension and providing a passageway for fluid to be flushed into the sheath body.

2. A transcarotid access device as in claim 1, further comprising an eyelet located on the connector that connects the elongated tubing to the adapter.

3. A transcarotid access device as in claim 1, wherein the valve transitions between an open state that permits flow out of the internal lumen of the transcarotid access device and a closed state that blocks flow out of the internal lumen of the transcarotid access device.

4. A transcarotid access device as in claim 1, further comprising a tubular sheath stopper that can be positioned over the sheath body so as to cover a portion of the sheath body and expose a portion of the sheath body, wherein the sheath stopper limits insertion of the sheath body into the carotid artery to the exposed distal portion of the sheath body, and wherein a flange is positioned at a distal end of the sheath stopper.

5. A transcarotid access device as in claim 4, wherein the flange is inflatable or mechanically expandable.

6. A transcarotid access device as in claim 4, wherein the flange is primarily oriented along an axis that is non-perpendicular to a longitudinal axis of the sheath stopper.

7. A transcarotid access device, comprising:

an arterial access sheath having a sheath body defining an internal lumen, the sheath body sized and shaped to be introduced into a common carotid artery and receive blood flow from the carotid artery;

an adapter at a proximal end of the sheath body, the adapter having a hub adapted to be removably connected to a flow shunt line, the adapter further having a valve positioned immediately adjacent to an internal lumen of the transcarotid access device, wherein the valve regulates fluid flow out of the internal lumen of the transcarotid access device toward the hub;

a proximal extension connected to a proximal end of the adapter, the proximal extension formed of an elongated body;

a hemostasis valve at a proximal end of the proximal extension such that the proximal extension spaces apart the hemostasis valve from the adapter; and

a flush line connected to a proximal end of the proximal extension and providing a passageway for fluid to be flushed into the sheath body.

8. A transcarotid access device as in claim 7, further comprising an eyelet located on the connector that connects the sheath body to the adapter.

9. A transcarotid access device as in claim 7, wherein the valve transitions between an open state that permits flow out of the internal lumen of the transcarotid access device and a closed state that blocks flow out of the internal lumen of the transcarotid access device.

10. A transcarotid access device as in claim 7, further comprising a sheath stopper that can be positioned over the sheath body so as to cover a portion of the sheath body and expose a portion of the sheath body, wherein the sheath stopper limits insertion of the sheath body into the carotid artery to the exposed distal portion of the sheath body, and wherein a flange is positioned at a distal end of the sheath stopper.

11. A transcarotid access device as in claim 7, further comprising a flow shunt line that removably connects to the hub of the adapter, and further comprising a single housing on the flow shunt line, the housing containing:

a flow control element that can be actuated between a low flow state and a high flow state for flow through the flow shunt;

a valve that can transition between an open state that permits flow through the flow shunt and a closed state that blocks flow through the flow shunt;

a fluid filter; and

a one-way check valve.

12. A transcarotid access device as in claim 11, wherein the flow shunt line shunts fluid flow from the access device to a return site.