# US 11,077,239 B2 · Tributary access device and methods of use

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- Number: US 11,077,239 B2
- Document ID: US11077239B2
- Status: Granted
- Kind: B2
- Application number: 15/916,299
- Filed: 2018-03-09
- Published: 2018-09-20
- Granted: 2021-08-03
- Earliest claimed: 2017-03-18
- Applicants: Hemocleanse, Inc.
- Inventors: Stephen Richard Ash
- Web page: https://patentgrep.com/patent/US11077239B2

## CPC

- A61M 1/3653: {Interfaces between patient blood circulation and extra-corporal blood circuit}
- A61B 17/11: for performing anastomosis; Buttons for anastomosis
- 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)
- A61M 1/3655: {Arterio-venous shunts or fistulae}
- A61M 1/3659: {Cannulae pertaining to extracorporeal circulation}
- A61B 2017/1107: {for blood vessels}
- A61B 2017/1135: {End-to-side connections, e.g. T- or Y-connections}
- A61F 2/06: Blood vessels
- A61F 2/064: {with special features to facilitate anastomotic coupling (anastomosis of natural blood vessels A61B17/11)}
- A61F 2/07: Stent-grafts
- A61F 2/2475: {Venous valves}
- 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)}
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)
- A61F: FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS (dental prosthetics A61C)

## Abstract

Described herein are devices and methods for vascular access via the tributaries. A single lumen catheter, with a bidirectional valve at the tip is disclosed. Flow is out the longitudinal tip of the catheter and not the sides. The two-way valve will act passively but has low opening and closing pressures. A method utilizing endo-to-side port placement of said catheter in vasculature is disclosed. Anastomosis methods are described using said catheter.

## Claims

### Claim 1

A method to access a vasculature comprising:
providing a tributary access device (TAD); wherein the TAD comprises a single-lumen catheter,
passing the single-lumen catheter through a skin of a user, then
passing the single-lumen catheter through a tributary vessel towards a nearby junction with a target vessel, and
positioning the single-lumen catheter so that a tip of the catheter extends no more than 1-3 millimeters within a wall of the target vessel,
wherein the catheter is connected to the target vessel in an end-to-side connection by neo-intimal sheathing or stenosis of the tributary vessel and without surgical anastomosis of the target vessel or the tributary vessel.

### Claim 2 (depends on 1)

The method of claim 1, wherein the single-lumen catheter comprises a subcutaneous cuff, a bi-directional valve, and an external connector, wherein the bi-directional valve is in the tip of the catheter, wherein the subcutaneous cuff is on an opposite half of the catheter from the tip, and wherein the external connector is pre-attached or molded to a catheter end opposite from the tip.

### Claim 3 (depends on 2)

The method of claim 2, wherein the catheter is placed by over the wire techniques common in interventional specialties.

### Claim 4 (depends on 2)

The method of claim 2, wherein the target vessel has low or negative pressure, and the rate of blood removal is low enough so that the target vessel does not collapse.

### Claim 5 (depends on 2)

The method of claim 2, wherein the tributary access device is placed in an artery for blood removal.

### Claim 6 (depends on 2)

The method of claim 2, wherein the tributary access device is placed in a vein for fluid delivery.

### Claim 7 (depends on 6)

The method of claim 6, wherein the catheter is placed in a femoral vein.

### Claim 8 (depends on 2)

The method of claim 2, wherein the catheter is placed in an artery or vein with a high flow rate and continued positive pressure.

### Claim 9 (depends on 2)

The method of claim 2, wherein the catheter is placed into a tributary vessel, further comprising a flexible connector pre-attached or molded to the catheter to attach the catheter to the tributary vessel.

### Claim 10 (depends on 1)

The method of claim 1 wherein the catheter is directed to enter a tributary vessel, and advanced through the tributary vessel so that the catheter tip extends into the target vessel.

### Claim 11

A method for continuous-flow extracorporeal therapies comprising:
providing a first tributary access device (first TAD) and a second tributary access device (second TAD), each comprising a single-lumen catheter,
connecting the first TAD single-lumen catheter to a first location and the second TAD single-lumen catheter to a second location through a method to access a vasculature comprising:
passing each single-lumen catheter through a skin of a user, then
passing each single-lumen catheter towards a nearby junction with a target vessel, and
positioning each catheter so that a tip extends no more than 1-3 millimeters within a wall of the target vessel,
wherein each single-lumen catheter is connected to the target vessel in an end-to-side connection by neo-intimal sheathing or stenosis and without surgical anastomosis,
removing blood from a first vessel via the first TAD single-lumen catheter at the first location, and
returning blood to a second vessel via the second TAD single-lumen catheter at the second location, wherein the first and the second vessels are selected from the group consisting of an artery and a vein.

### Claim 12 (depends on 11)

The method of claim 11, wherein the first vessel, is a first vein and the second vessel is a second vein.

### Claim 13 (depends on 11)

The method of claim 11, wherein the first vessel is a first vein and the second vessel is in the first vein at a distance from the first location.

### Claim 14 (depends on 11)

The method of claim 11, wherein [the] each single-lumen catheter comprises a subcutaneous cuff, a bi-directional valve, and an external connector, wherein the bi-directional valve is in the tip of the catheter, wherein the subcutaneous cuff is on an opposite half of the catheter from the tip, and wherein the external connector is pre-attached or molded to a catheter end opposite from the tip.
