# US 11,433,226 B2 · Methods and systems for establishing retrograde carotid arterial blood flow

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- Number: US 11,433,226 B2
- Document ID: US11433226B2
- Status: Granted
- Kind: B2
- Application number: 16/299,524
- Filed: 2019-03-12
- Published: 2019-12-05
- Granted: 2022-09-06
- Earliest claimed: 2015-04-10
- Assignees: Silk Road Medical, Inc.
- Applicants: Silk Road Medical, Inc.
- Inventors: Stewart M. Kume; Sieu T. Duong; Michi E. Garrison
- Web page: https://patentgrep.com/patent/US11433226B2

## CPC

- A61M 1/3613: {Reperfusion, e.g. of the coronary vessels, e.g. retroperfusion}
- A61M 1/3653: {Interfaces between patient blood circulation and extra-corporal blood circuit}
- A61M 1/3656: {Monitoring patency or flow at connection sites; Detecting disconnections}
- A61M 1/3659: {Cannulae pertaining to extracorporeal circulation}
- 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})
- A61M 39/06: Haemostasis valves, i.e. gaskets sealing around a needle, catheter or the like, closing on removal thereof
- A61M 39/223: {Multiway valves}
- A61M 2205/3334: Measuring or controlling the flow rate
- A61M 2205/7545: for solid matter, e.g. microaggregates
- A61M: DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY (introducing media into or onto the bodies of animals A61D7/00; means for inserting tampons A61F13/26; devices for administering food or medicines orally A61J; containers for collecting, storing or administering blood or medical fluids A61J1/05); DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY (surgery A61B; chemical aspects of surgical articles A61L); DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR {(Electrotherapy, e.g. producing anaesthesia by the use of alternating or intermittent currents A61N1/36021)}

## 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

### Claim 1

A method of treating an artery, comprising:
inserting an arterial access sheath into an opening in a common carotid artery, the arterial access sheath comprising:
a sheath body defining an internal lumen;
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;
treating the artery via the arterial access sheath.

### Claim 2 (depends on 1)

A method of treating an artery as in claim 1, the arterial access sheath further comprising an eyelet located on the connector that connects the elongated tubing to the adapter.

### Claim 3 (depends on 1)

A method of treating an artery 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.

### Claim 4 (depends on 1)

A method of treating an artery as in claim 1, the arterial access sheath 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.

### Claim 5 (depends on 4)

A method of treating an artery as in claim 4, wherein the flange is inflatable or mechanically expandable.

### Claim 6 (depends on 4)

A method of treating an artery 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.