# US 11,027,107 B2 · Subcutaneous vascular access assemblies and related devices and methods

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- Number: US 11,027,107 B2
- Document ID: US11027107B2
- Status: Granted
- Kind: B2
- Application number: 15/783,004
- Filed: 2017-10-13
- Published: 2018-04-19
- Granted: 2021-06-08
- Earliest claimed: 2016-10-19
- Assignees: Merit Medical Systems, Inc.
- Applicants: Merit Medical Systems, Inc.
- Inventors: Mark Garcia; John Hall; Wayne Mower
- Web page: https://patentgrep.com/patent/US11027107B2

## CPC

- A61M 39/0208: {Subcutaneous access sites (implantable infusion devices A61M5/14276; transcutaneous access sites A61M39/0247)}
- A61B 17/3468: {for implanting or removing devices, e.g. prostheses, implants, seeds, wires (devices for implanting seeds A61M37/0069)}
- A61F 2/064: {with special features to facilitate anastomotic coupling (anastomosis of natural blood vessels A61B17/11)}
- A61F 2/07: Stent-grafts
- A61M 1/14: Dialysis systems; Artificial kidneys; Blood oxygenators (semi-permeable membranes characterised by the material, manufacturing processes therefor B01D71/00){; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis}
- A61M 1/3655: {Arterio-venous shunts or fistulae}
- A61M 25/0194: {Tunnelling catheters}
- A61M 39/04: having pierceable self-sealing members
- A61M 39/06: Haemostasis valves, i.e. gaskets sealing around a needle, catheter or the like, closing on removal thereof
- A61B 2017/00292: {mounted on or guided by flexible, e.g. catheter-like, means}
- A61F 2/856: Single tubular stent with a side portal passage
- A61F 2/954: for placing stents or stent-grafts in a bifurcation
- A61F 2002/061: {provided with means for allowing access to secondary lumens}
- A61F 2002/065: {Y-shaped blood vessels}
- A61M 2039/0223: {having means for anchoring the subcutaneous access site}
- A61M 2210/125: Heart
- 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

Vascular access devices, assemblies, kits, and related methods are disclosed. A vascular access assembly may include a first tubular conduit, a second tubular conduit, and an expandable stent graft that is coupled adjacent to a peripheral end of the second tubular conduit. When implanted into the patient, vascular access assemblies may form a flow path that extends from an artery or an arteriovenous graft to a heart of a patient. The vascular access assembly, when implanted and assembled, may be a fully subcutaneous surgical implant.

## Claims

### Claim 1

A vascular access assembly comprising:
a first tubular conduit;
a second tubular conduit;
an expandable stent graft that is coupled to the second tubular conduit adjacent a peripheral end of the second tubular conduit, wherein the expandable stent graft includes a first branch configured to couple to an artery, vein or arteriovenous graft of a patient such that the first branch permits blood flow through the artery, vein, or arteriovenous graft, wherein the expandable stent graft includes a second branch coupled to the second tubular conduit such that the artery, the vein, or the arteriovenous graft is in fluid communication with the second tubular conduit;
a restraint comprising a pull string coupled to filaments surrounding the expandable stent graft in a compressed state;
wherein the first tubular conduit is configured to couple to a central end of the second tubular conduit to form a flow path that extends from the artery, the vein, or the arteriovenous graft to a heart of the patient.

### Claim 2 (depends on 1)

The vascular access assembly of claim 1, wherein the expandable stent graft comprises a T-shape.

### Claim 3 (depends on 1)

The vascular access assembly of claim 1, wherein the second tubular conduit comprises a puncturable and self-sealing wall such that the wall may be punctured by insertion of a needle and then reseal upon withdrawal of the needle.

### Claim 4 (depends on 1)

The vascular access assembly of claim 1, further comprising a connector for coupling the first tubular conduit to the second tubular conduit.

### Claim 5 (depends on 1)

The vascular access assembly of claim 1, wherein the second tubular conduit is configured for delivery through a lumen of a deployment device.

### Claim 6 (depends on 1)

The vascular access assembly of claim 1, wherein the flow path extends from the brachial artery to a right atrium of the heart.

### Claim 7 (depends on 1)

The vascular access assembly of claim 1, wherein the vascular access assembly is configured to be implanted without establishing a venous anastomosis.

### Claim 8 (depends on 1)

The vascular access assembly of claim 1, further comprising a valve disposed adjacent a central end of the second tubular conduit, wherein the valve is configured to allow blood flow across the valve when the second tubular conduit is coupled to the first tubular conduit and to prevent blood flow across the valve when the second tubular conduit is uncoupled from the first tubular conduit.

### Claim 9 (depends on 1)

The vascular access assembly of claim 1, wherein the expandable stent graft is a self-expanding stent graft.

### Claim 10 (depends on 1)

The vascular assembly of claim 1, further comprising a tubular liner that is disposed within both the expandable stent graft and the second tubular conduit, wherein the tubular liner provides a continuous luminal surface for contact with blood of the patient.

### Claim 11 (depends on 1)

The vascular assembly of claim 1, further comprising a first therapeutic agent that is associated with one or both of an inner surface and an outer surface of the vascular access assembly, wherein the vascular access assembly is configured to deliver a therapeutically effective dose of the first therapeutic agent to the patient when the vascular access assembly is implanted within the patient.

### Claim 12

A method for implanting a vascular access assembly into a patient, the method comprising:
inserting a central end of a first tubular conduit into a patient such that the central end of the first tubular conduit is positioned within a right atrium of a heart of the patient;
tunneling a peripheral end of the first tubular conduit through flesh of the patient to an incision adjacent a shoulder of the patient;
inserting a second tubular conduit into the patient such that the second tubular conduit extends from the incision adjacent the shoulder of the patient to an incision in the arm of the patient;
deploying a stent graft within an artery or an arteriovenous graft in the arm of the patient, wherein the stent graft is coupled to and disposed adjacent a peripheral end of the second tubular conduit;
pulling a pull string to remove a restraint from around the stent graft, wherein the stent graft transitions from a compressed state to an expanded state;
sealing an insertion site of the artery or the arteriovenous graft with a collar disposed around a periphery of the stent graft; and
coupling the first tubular conduit to the second tubular conduit.

### Claim 13 (depends on 12)

The method of claim 12, wherein the stent graft is deployed in the brachial artery.

### Claim 14 (depends on 12)

The method of claim 12, wherein the stent graft is deployed in the artery of the patient and the stent graft is a branched stent graft.

### Claim 15 (depends on 12)

The method of claim 12, wherein implantation of the vascular access assembly does not involve venous anastomosis.

### Claim 16 (depends on 12)

The method of claim 12, wherein the stent graft is deployed in an arteriovenous graft and the stent graft is an unbranched stent graft.

### Claim 17 (depends on 16)

The method of claim 16, wherein the stent graft, when deployed, forms a fluid-tight seal that diverts the blood from the arteriovenous graft to a flow path that extends to the heart of the patient.

### Claim 18 (depends on 12)

The method of claim 12, wherein deploying the stent graft comprises inflating a balloon to expand to the stent graft.

### Claim 19 (depends on 18)

The method of claim 18, wherein the peripheral end of the second tubular conduit is tunneled through the flesh by passing the peripheral end of the second tubular conduit through a deployment device.

### Claim 20 (depends on 12)

The method of claim 12, wherein the pull string is coupled to filaments surrounding the stent graft in the compressed state.
