# US 12,178,435 B2 · Systems and methods for catheter feedback and control for AV fistula creation

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- Number: US 12,178,435 B2
- Document ID: US12178435B2
- Status: Granted
- Kind: B2
- Application number: 18/501,479
- Filed: 2023-11-03
- Published: 2024-03-07
- Granted: 2024-12-31
- Earliest claimed: 2017-05-17
- Assignees: Avenu Medical, Inc.
- Applicants: Avenu Medical, Inc.
- Inventors: Gene B. Reu; Brad M. Kellerman; Mark A. Ritchart; David K. Wrolstad; David T. Aldridge; Justin K. Mann
- Web page: https://patentgrep.com/patent/US12178435B2

## CPC

- A61B 17/11: for performing anastomosis; Buttons for anastomosis
- A61B 18/082: {Probes or electrodes therefor}
- A61B 5/01: Measuring temperature of body parts {; Diagnostic temperature sensing, e.g. for malignant or inflamed tissue} (clinical contact thermometers G01K13/20)
- A61B 17/3403: {Needle locating or guiding means}
- A61B 18/1492: {having a flexible, catheter-like structure, e.g. for heart ablation (A61B18/1477 takes precedence)}
- A61M 1/3623: {Means for actively controlling temperature of blood}
- A61M 1/3655: {Arterio-venous shunts or fistulae}
- A61M 25/0105: {Steering means as part of the catheter or advancing means; Markers for positioning (systems for detection of markers A61B)}
- A61M 25/0194: {Tunnelling catheters}
- A61M 25/065: {Guide needles}
- A61B 17/00234: {for minimally invasive surgery (A61B17/0218, A61B17/0469, A61B17/12013, A61B17/1285, A61B17/29, A61B17/320016 take precedence)}
- A61B 2017/00725: {Calibration or performance testing}
- A61B 2017/00778: {Operations on blood vessels (A61B2017/22097, A61B2017/320741 take precedence)}
- A61B 2017/1107: {for blood vessels}
- A61B 2017/1139: {Side-to-side connections, e.g. shunt or X-connections}
- A61B 2017/3454: {Details of tips}
- A61B 2018/00404: {Blood vessels other than those in or around the heart}
- A61B 2018/0063: {Sealing}
- A61B 2018/00642: {with feedback, i.e. closed loop control}
- A61B 2018/00702: {Power or energy}
- A61B 2018/00791: {Temperature}
- A61B 2018/1425: {Needle}
- A61M 25/04: in the body, e.g. expansible {(A61M25/10, A61M16/0488 take precedence)}
- A61M 2025/0166: {Sensors, electrodes or the like for guiding the catheter to a target zone, e.g. image guided or magnetically guided}
- A61M 2025/0197: {for creating an artificial passage within the body, e.g. in order to go around occlusions}
- 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

A method of operating a catheter assembly including monitoring a gap feedback signal indicative of a distance between a first tissue contact surface and a second tissue contact surface. Producing, via a user interface of the catheter assembly, a graphical depiction of the first tissue contact surface and the second tissue contact surface spaced apart from the first tissue contact surface by the distance. Producing, via the user interface of the catheter assembly, a gap distance warning when the gap feedback signal indicates that the distance is outside of a target gap range.

## Claims

### Claim 1

A method of operating a catheter assembly including a first tissue contact surface, a second tissue contact surface, a heating element coupled to the first tissue contact surface, and a gap feedback sensor configured to produce a gap feedback signal associated with a distance between the first tissue contact surface and the second tissue contact surface, the method comprising:
monitoring the gap feedback signal indicative of the distance between the first tissue contact surface and the second tissue contact surface;
producing via a user interface of the catheter assembly, a graphical depiction of the first tissue contact surface by the distance; and
producing, via the user interface of the catheter assembly, a gap distance warning when the gap feedback signal indicates that the distance is outside of a target gap range.

### Claim 2 (depends on 1)

The method of claim 1, wherein the graphical depiction shows at least one of the first tissue contact surface or the second tissue contact surface moving in response to a change in the distance.

### Claim 3 (depends on 1)

The method of claim 1, further comprising producing, via the user interface of the catheter assembly, a first gap distance warning including a graphical display indicating that the gap distance is too low when the gap feedback signal indicates that the distance is below the target gap range, and producing a second gap distance warning including a graphical display indicating that the gap distance is too high when the gap feedback signal indicates that the distance is above the target gap range.

### Claim 4 (depends on 3)

The method of claim 3, wherein the first gap distance warning shows an image of the catheter assembly having a first gap between the contact surfaces, and the second gap distance warning shows an image of the catheter assembly having a second gap between the contact surfaces that is larger than the first gap.

### Claim 5 (depends on 4)

The method of claim 4, wherein the first and second gap distance warnings show a numerical value of the distance between the contact surfaces.

### Claim 6 (depends on 1)

The method of claim 1, further comprising:
receiving a start instruction from the user interface;
sending, from a control module of the catheter assembly, a heat signal to the heating element of the catheter assembly; and
producing, via the user interface, a heat indicator in response to the heat signal.

### Claim 7 (depends on 6)

The method of claim 6, wherein the catheter assembly includes a temperature sensor coupled to the first tissue contact surface, the method further comprising:
receiving a temperature feedback signal from the temperature sensor, the heat indicator including a graphical indication associated with the temperature feedback signal.

### Claim 8 (depends on 6)

The method of claim 6, wherein the heat indicator includes a graphical depiction and an audible tone, the graphical depiction indicating a hot portion of one of the first tissue contact surface or the second tissue contact surface.

### Claim 9 (depends on 6)

The method of claim 6, wherein the heat indicator includes a series of colored regions surrounding a tip of the catheter assembly indicating that the tip is hot.

### Claim 10 (depends on 1)

The method of claim 1, further comprising preventing initiation of a heating cycle to produce a fistula when the gap feedback signal indicates that the distance is outside of the target gap range.