# US 11,026,743 B2 · Devices and methods for forming a fistula

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- Number: US 11,026,743 B2
- Document ID: US11026743B2
- Status: Granted
- Kind: B2
- Application number: 15/406,755
- Filed: 2017-01-15
- Published: 2017-07-20
- Granted: 2021-06-08
- Earliest claimed: 2016-01-15
- Assignees: TVA Medical, Inc.
- Applicants: TVA Medical, Inc.
- Inventors: Thomas D. Pate; Dana R. Mester; William E. Cohn; Philip M. Tetzlaff
- Web page: https://patentgrep.com/patent/US11026743B2

## CPC

- A61B 18/1492: {having a flexible, catheter-like structure, e.g. for heart ablation (A61B18/1477 takes precedence)}
- A61B 6/12: Arrangements for detecting or locating foreign bodies
- A61B 6/485: {involving fluorescence X-ray imaging}
- A61B 6/487: {involving fluoroscopy}
- A61B 6/504: {for diagnosis of blood vessels, e.g. by angiography}
- A61B 17/11: for performing anastomosis; Buttons for anastomosis
- A61B 18/042: {using additional gas becoming plasma}
- A61M 25/0108: {using radio-opaque or ultrasound markers}
- A61M 25/0127: {Magnetic means; Magnetic markers}
- A61M 25/0662: {Guide tubes}
- A61M 39/06: Haemostasis valves, i.e. gaskets sealing around a needle, catheter or the like, closing on removal thereof
- A61B 2017/00876: {magnetic}
- A61B 2017/1107: {for blood vessels}
- A61B 2017/1139: {Side-to-side connections, e.g. shunt or X-connections}
- A61B 2018/00101: {low, i.e. thermally insulating}
- A61B 2018/00214: {Expandable means emitting energy, e.g. by elements carried thereon}
- A61B 2018/00345: {Vascular system}
- A61B 2018/00404: {Blood vessels other than those in or around the heart}
- A61B 2018/00577: {Ablation}
- A61B 2018/00642: {with feedback, i.e. closed loop control}
- A61B 2018/00875: {Resistance or impedance}
- A61B 2018/144: {Wire}
- A61B 2090/3966: {Radiopaque markers visible in an X-ray image}
- A61N 1/05: for implantation or insertion into the body, e.g. heart electrode (A61N1/06 takes precedence)
- 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)}
- A61N: ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY (measurement of bioelectric currents A61B; surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body A61B18/00; anaesthetic apparatus in general A61M; incandescent lamps H01K; infrared radiators for heating H05B)

## Abstract

Described here are devices, systems, and methods for forming a fistula between two blood vessels. The systems may comprise a first catheter including a housing and an electrode having a proximal end and a distal end. The proximal end is fixed relative to the housing and the distal end is longitudinally slidable within the housing.

## Claims

### Claim 1

A system for forming a fistula between two vessels comprising:
a first catheter comprising a housing and an electrode,
wherein the electrode comprises a proximal end, an upturned distal end, and an intermediate portion between the proximal end and the upturned distal end,
wherein the electrode varies in width along a length defined from the proximal end to the intermediate portion,
wherein the upturned distal end is upturned relative to a longitudinal axis of the electrode,
wherein the proximal end of the electrode is fixed relative to the housing and the upturned distal end of the electrode is freely longitudinally slidable within the housing toward a tip of the catheter away from the proximal end; and
wherein the electrode is positioned within a lumen of the housing, the lumen comprising a first diameter portion positioned proximal to an opening and a second diameter portion positioned proximal to the opening, wherein the second diameter portion comprises a smaller diameter than the first diameter portion, and the electrode is fixed to the housing at the second diameter portion.

### Claim 2 (depends on 1)

The system of claim 1, wherein the opening comprises a side opening and the intermediate portion of the electrode extends into and out of the side opening radially beyond an outer radius of the housing.

### Claim 3 (depends on 1)

The system of claim 1, wherein the electrode comprises a leaf spring.

### Claim 4 (depends on 1)

The system of claim 1, wherein the first catheter comprises a fluid seal to prevent fluid ingress into the first catheter at the proximal end of the electrode.

### Claim 5 (depends on 1)

The system of claim 1, wherein the electrode varies in height along its length.

### Claim 6 (depends on 1)

The system of claim 1, wherein the intermediate portion of the electrode comprises a plurality of bends.

### Claim 7 (depends on 1)

The system of claim 1, wherein the intermediate portion comprises a bend of less than about 40 degrees.

### Claim 8 (depends on 1)

The system of claim 1, wherein the electrode comprises a low-profile configuration in which the electrode is recessed into the housing.

### Claim 9 (depends on 1)

The system of claim 1, wherein the housing comprises a reservoir between the proximal end of the electrode and a distal end of the first catheter, the reservoir configured to hold fluid, and wherein the electrode is configured to generate plasma from the fluid in the reservoir.

### Claim 10 (depends on 1)

The system of claim 1, further comprising a second catheter comprising a second housing and a protruding backstop.

### Claim 11 (depends on 10)

The system of claim 10, wherein the second catheter comprises a recessed portion opposite the protruding backstop across a longitudinal axis of the second catheter, wherein the recessed portion has a complementary shape to the protruding backstop.

### Claim 12 (depends on 1)

The system of claim 1, further comprising a second catheter comprising a recessed backstop, wherein the recessed backstop has a shape that is complementary to a portion of the electrode.

### Claim 13 (depends on 12)

The system of claim 12, wherein the recessed backstop has a shape that is complementary to the intermediate portion of the electrode.

### Claim 14 (depends on 13)

The system of claim 13, wherein the electrode comprises an extended configuration in which the electrode is extended away from the housing, and wherein the complementary shape corresponds to a shape of the electrode in the extended configuration.

### Claim 15 (depends on 12)

The system of claim 12, where the shape comprises a concave portion comprising an opening configured to receive the electrode.

### Claim 16 (depends on 1)

The system of claim 1, wherein the first catheter comprises a first coaption region comprising a flat coaption surface.

### Claim 17 (depends on 16)

The system of claim 16, wherein the first coaption region has a square or rectangular cross-section.

### Claim 18 (depends on 16)

The system of claim 16, further comprising a second catheter comprising a second coaption region comprising a flat coaption surface.

### Claim 19 (depends on 18)

The system of claim 18, wherein the second coaption region has a square or rectangular cross-section.

### Claim 20 (depends on 18)

The system of claim 18, wherein the first coaption region comprises a first magnet and the second coaption region comprises a second magnet.

### Claim 21 (depends on 1)

The system of claim 1, wherein the first catheter comprises a first handle, and the system further comprises a second catheter comprising a second handle, wherein the first handle and the second handle each comprise a flat surface.

### Claim 22 (depends on 21)

The system of claim 21, wherein the first handle comprises a first magnet and the second handle comprises a second magnet.

### Claim 23 (depends on 1)

The system of claim 1, wherein the first catheter comprises a rotational indicator comprising a radiopaque material.

### Claim 24 (depends on 1)

The system of claim 1, wherein a width of the proximal end of the electrode is greater than the width of the intermediate portion of the electrode.

### Claim 25 (depends on 1)

The system of claim 1, wherein the width of the electrode tapers from the proximal end to the intermediate portion.

### Claim 26 (depends on 1)

The system of claim 1, wherein the tip of the catheter is a rapid exchange tip, and the upturned distal end of the electrode remains spaced from the rapid exchange tip.
