# US 12,109,347 B2 · Device and method for atraumatic and percutaneous formation of an arteriovenous fistula

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- Number: US 12,109,347 B2
- Document ID: US12109347B2
- Status: Granted
- Kind: B2
- Application number: 17/880,574
- Filed: 2022-08-03
- Published: 2022-11-24
- Granted: 2024-10-08
- Earliest claimed: 2017-06-19
- Assignees: The Regents of the University of California
- Applicants: The Regents of the University of California
- Inventors: Shant Vartanian
- Web page: https://patentgrep.com/patent/US12109347B2

## CPC

- A61F 2/07: Stent-grafts
- A61M 1/3655: {Arterio-venous shunts or fistulae}
- A61B 17/11: for performing anastomosis; Buttons for anastomosis
- A61F 2/064: {with special features to facilitate anastomotic coupling (anastomosis of natural blood vessels A61B17/11)}
- A61F 2/848: having means for fixation to the vessel wall, e.g. barbs
- A61F 2/95: Instruments specially adapted for placement or removal of stents or stent-grafts
- A61L 31/022: {Metals or alloys}
- A61L 31/048: {obtained by reactions only involving carbon-to-carbon unsaturated bonds (A61L31/041 takes precedence)}
- A61M 1/3661: {for haemodialysis}
- A61M 39/0208: {Subcutaneous access sites (implantable infusion devices A61M5/14276; transcutaneous access sites A61M39/0247)}
- A61B 2017/00477: {Coupling (A61B2017/0046 takes precedence)}
- A61B 2017/00862: {elastic or resilient}
- A61B 2017/00867: {shape memory effect}
- A61B 2017/00876: {magnetic}
- A61B 2017/1107: {for blood vessels}
- A61B 2017/1139: {Side-to-side connections, e.g. shunt or X-connections}
- A61B 2090/3966: {Radiopaque markers visible in an X-ray image}
- A61F 2/966: with relative longitudinal movement between outer sleeve and prosthesis, e.g. using a push rod
- A61F 2002/8486: {provided on at least one of the ends}
- A61F 2210/009: magnetic
- A61F 2230/005: Rosette-shaped, e.g. star-shaped
- A61F 2230/0067: conical
- A61F 2230/0078: hyperboloidal
- A61F 2250/0039: differing in diameter
- A61L 2400/16: Materials with shape-memory or superelastic properties
- A61M 39/0247: {Transcutaneous or percutaneous access sites to the inside of the body}
- A61M 2039/0223: {having means for anchoring the subcutaneous access site}
- A61M 2039/0626: {used with other surgical instruments, e.g. endoscope, trocar}
- 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)
- 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)
- A61L: METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES (preservation of bodies or disinfecting characterised by the agents employed A01N; preserving, e.g. sterilising, food or foodstuffs A23; preparations for medical, dental or toiletry purposes A61K)

## Abstract

Provided herein are novel devices for the formation of arteriovenous fistulas, which may aid subjects in need of hemodialysis. The novel devices are provided in a non-surgical procedure, greatly decreasing the cost and increasing the convenience of placing an arteriovenous fistula. The devices are atraumatic, and consist of a sutureless anastomosis device and conduit. Methods and tools for placing the devices in vivo are disclosed, including a magnetic-assisted method.

## Claims

### Claim 1

A method of bringing into contact a wall of a first blood vessel and a wall of a second blood vessel in a subject, the method comprising: advancing a first catheter having a magnetized end face through the first vessel to a target site; advancing a second catheter having a magnetized end face through the second vessel to the target site, wherein magnetic attraction between the magnetized end faces of the first and second catheters brings a wall of the first blood vessel into contact with a wall of the second blood vessel at the target site, wherein the first blood vessel is a deep artery and the second blood vessel is a superficial vein.

### Claim 2 (depends on 1)

The method of claim 1, further comprising piercing the walls of the first and second blood vessels in contact with each other.

### Claim 3 (depends on 2)

The method of claim 2, wherein the piercing is performed using a cutting element deployed from the end face of the first catheter.

### Claim 4 (depends on 3)

The method of claim 3, further comprising retracting the deployed cutting element into the first catheter subsequent to piercing the walls of the first and second blood vessels.

### Claim 5 (depends on 3)

The method of claim 3, wherein the cutting element is a guide wire comprising a needle tip deployed to act as both the cutting element and a guide wire.

### Claim 6 (depends on 2)

The method of claim 2, further comprising extending a guide wire from the end face of the first catheter into a lumen of the second catheter via the end face of the second catheter.

### Claim 7 (depends on 6)

The method of claim 6, further comprising extending the end face of the first catheter into the second blood vessel.

### Claim 8 (depends on 7)

The method of claim 7, wherein the first catheter houses an anastomosis device, and wherein the method further comprises deploying the anastomosis device to create a fistula between the first and second blood vessels at the target site.

### Claim 9 (depends on 8)

The method of claim 8, wherein the anastomosis device comprises: an annular body comprising an opening; a first set of deployable hands, and a second set of deployable hands.

### Claim 10 (depends on 9)

The method of claim 9, wherein deploying the anastomosis device comprises partially ejecting the anastomosis device from the magnetic end face of the first catheter such that the first set of hands of the anastomosis device is deployed inside the second vessel.

### Claim 11 (depends on 10)

The method of claim 10, wherein deploying the anastomosis device further comprises withdrawing the first catheter into the first blood vessel such that the tip of the first catheter is pulled back into the first blood vessel and the first set of hands catch the wall of the second blood vessel.

### Claim 12 (depends on 11)

The method of claim 11, wherein deploying the anastomosis device further comprises ejecting the anastomosis device from the first magnetic end face of the first catheter to deploy the second set of hands of the anastomosis device such that the walls of the first and second blood vessels are sandwiched between the first set of hands and the second set of hands of the anastomosis device.

### Claim 13 (depends on 1)

The method of claim 1, wherein the magnetized end face of the first catheter and the magnetized end face of the second catheter comprise ring shaped magnets that define the end faces of the first catheter and the second catheter.

### Claim 14 (depends on 13)

The method of claim 13, wherein the center portion of the magnetized end face of the first catheter and the magnetized end face of the second catheter is hollow and allows advancement of a cutting element and a guide wire.

### Claim 15 (depends on 1)

The method of claim 1, further comprising creating a fistula between the first and second blood vessels at the target site.