# US 12,178,501 B2 · Devices and methods for forming a fistula

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- Number: US 12,178,501 B2
- Document ID: US12178501B2
- Status: Granted
- Kind: B2
- Application number: 17/342,204
- Filed: 2021-06-08
- Published: 2021-12-02
- Granted: 2024-12-31
- Earliest claimed: 2010-11-16
- Assignees: TVA Medical, Inc.
- Applicants: TVA Medical, Inc.
- Inventors: Gary H. Miller; Adam L. Berman; William E. Cohn; Dana R. Mester; Damian A. Jelich
- Web page: https://patentgrep.com/patent/US12178501B2

## CPC

- A61B 18/1492: {having a flexible, catheter-like structure, e.g. for heart ablation (A61B18/1477 takes precedence)}
- A61B 17/320016: {Endoscopic cutting instruments, e.g. arthroscopes, resectoscopes (A61B10/0233, A61B17/29, A61B17/3207 take precedence)}
- A61B 17/320725: {with radially expandable cutting or abrading elements (A61B17/32075 takes precedence)}
- A61B 18/16: Indifferent or passive electrodes for grounding
- A61M 1/3655: {Arterio-venous shunts or fistulae}
- A61B 2017/00778: {Operations on blood vessels (A61B2017/22097, A61B2017/320741 take precedence)}
- A61B 2017/00876: {magnetic}
- A61B 2017/22095: {accessing a blood vessel true lumen from the sub-intimal space}
- A61B 2017/320791: {with cutter extending outside the cutting window}
- A61B 2018/00083: {low, i.e. electrically insulating}
- A61B 2018/00107: {Coatings on the energy applicator}
- A61B 2018/00172: {Connectors and adapters therefor}
- A61B 2018/00404: {Blood vessels other than those in or around the heart}
- A61B 2018/00577: {Ablation}
- A61B 2018/00625: {Vaporization}
- A61B 2018/1253: {monopolar}
- A61B 2018/144: {Wire}
- A61B 2090/3925: {ultrasonic}
- A61B 2090/3966: {Radiopaque markers visible in an X-ray image}
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)
- 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

Described here are devices, systems and methods for forming a fistula between two blood vessels. Generally, the systems may comprise a first catheter which may comprise a fistula-forming element. The fistula-forming element may comprise one or more electrodes, mechanical cutting elements, laser sources, or combinations thereof, and may be used to assist in fistula formation. In some instances, a system may comprise a second catheter, which may comprise a fistula-forming element. One or more of the catheters may comprise one or more markers, magnetic alignment elements, and/or one shape-changing elements.

## Claims

### Claim 1

A system for forming a fistula between two blood vessels comprising: a catheter comprising a catheter body, a fistula forming element coupled to the catheter body and adapted to form the fistula when activated, and a marker band circumferentially arranged around the catheter body and comprising a direction indicator indicating a directional position of the fistula forming element, wherein the marker band comprises a first cut-out region and a second cut-out region adapted to substantially overlap when the catheter is in a rotational orientation for activating the fistula forming element to form the fistula.

### Claim 2 (depends on 1)

The system of claim 1, wherein the marker band indicates a rotational alignment of the catheter.

### Claim 3 (depends on 1)

The system of claim 1, wherein the marker band is coupled to an exterior surface of the catheter body.

### Claim 4 (depends on 1)

The system of claim 1, wherein the marker band comprises echogenic or radiographic material.

### Claim 5 (depends on 1)

The system of claim 1, wherein the first or second cut-out region comprises a bi-lobular shape.

### Claim 6 (depends on 1)

The system of claim 1, wherein the first or second cut-out region comprises a directional shape, wherein the directional shape comprises a tapered portion that indicates a location of a fistula forming surface of the fistula forming element.

### Claim 7 (depends on 1)

The system of claim 1, wherein the fistula forming element comprises an ablation surface, and the ablation surface faces a direction perpendicular to the first and second cut-out regions.

### Claim 8 (depends on 1)

The system of claim 1, further comprising a second catheter comprising a marker band comprising a direction indicator indicating a position of the second catheter.