# US 12,465,721 B2 · Controllable expandable catheter

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- Number: US 12,465,721 B2
- Document ID: US12465721B2
- Status: Granted
- Kind: B2
- Application number: 18/477,342
- Filed: 2023-09-28
- Published: 2024-02-01
- Granted: 2025-11-11
- Earliest claimed: 2017-11-28
- Assignees: St. Jude Medical, Cardiology Division, Inc.
- Applicants: St. Jude Medical, Cardiology Division, Inc.
- Inventors: Gregory K. Olson; Rishi Manda; Travis Dahlen; Troy T. Tegg; Brian M. Monahan; Russell D. Terwey
- Web page: https://patentgrep.com/patent/US12465721B2

## CPC

- A61B 18/14: Probes or electrodes therefor
- A61M 25/0026: {Multi-lumen catheters with stationary elements (catheter assemblies comprising a catheter in combination with a guide tube, sheath or sleeve A61M2025/0681; catheters comprising telescoping coaxial elements A61M2025/0175)}
- A61M 25/0009: {Making of catheters or other medical or surgical tubes}
- A61M 25/0032: {characterized by at least one unconventionally shaped lumen, e.g. polygons, ellipsoids, wedges or shapes comprising concave and convex parts}
- A61M 25/0144: {having flexible regions as a result of inner reinforcement means, e.g. struts or rods}
- A61M 25/10: Balloon catheters ({A61M25/0125 takes precedence; embolectomy A61B17/22032; retractors A61B17/02;} inflatable balloons for placing stents or stent-grafts A61F2/958 {; stomach balloons for treatment of obesity A61F5/0003; oesophagal tubes A61J15/00})
- A61B 18/1492: {having a flexible, catheter-like structure, e.g. for heart ablation (A61B18/1477 takes precedence)}
- A61B 34/25: {User interfaces for surgical systems}
- A61B 2017/00327: {with actuating members moving in opposite directions}
- A61B 2017/00867: {shape memory effect}
- A61B 2018/00214: {Expandable means emitting energy, e.g. by elements carried thereon}
- A61B 2018/00267: {having a basket shaped structure}
- A61B 2018/00357: {Endocardium}
- A61B 2018/00577: {Ablation}
- A61B 2018/00791: {Temperature}
- A61B 2018/00821: {measured by a thermocouple}
- A61B 2018/0212: {using an instrument inserted into a body lumen, e.g. catheter}
- A61B 2018/1405: {Electrodes having a specific shape}
- A61B 2090/033: {Abutting means, stops, e.g. abutting on tissue or skin}
- A61B 2090/034: {abutting on parts of the device itself}
- A61B 2218/002: Irrigation
- A61M 25/0045: {multi-layered, e.g. coated (coating materials A61L29/08)}
- A61M 25/0054: {with regions for increasing flexibility}
- A61M 25/0136: {Handles therefor}
- A61M 25/0141: {having flexible regions as a result of using materials with different mechanical properties}
- A61M 25/0147: {with movable mechanical means, e.g. pull wires}
- A61M 2025/0035: {characterized by a variable lumen cross-section by means of a resilient flexible septum or outer wall}
- A61M 2025/0036: {with more than four lumina}
- A61M 2025/0037: {characterized by lumina being arranged side-by-side}
- A61M 2025/0046: {Coatings for improving slidability}
- A61M 2025/0063: {having means, e.g. stylets, mandrils, rods or wires to reinforce or adjust temporarily the stiffness, column strength or pushability of catheters which are already inserted into the human body}
- 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

Elongate medical devices with an expandable structure including elongated splines and a distal hub. An elongate medical device includes a handle including a control mechanism, a catheter shaft, an expandable structure including elongated splines and a distal hub, wherein each of the elongated splines includes a shape memory material and an interactive element, wherein each of the elongated splines includes a respective spline proximal end and a spline distal end, wherein each of the spline proximal ends is connected to the catheter shaft distal end, and wherein each of the spline distal ends is connected to the distal hub, and a deflection control member connected to the distal hub, wherein the control mechanism is drivingly coupled to the distal hub via the deflection control member and operable to selectively vary a position of the distal hub relative to the catheter shaft distal end to selectively vary an amount of expansion of the expandable structure, wherein a shape of the expandable structure is produced via a combination of the shape memory material and the position of the distal hub relative to the catheter distal end.

## Claims

### Claim 1

An electrophysiological catheter comprising:
a handle comprising a control mechanism;
a catheter shaft comprising a catheter shaft proximal end and a catheter shaft distal end, wherein the catheter shaft proximal end is connected to the handle;
an expandable structure comprising elongated splines and a distal hub, wherein each of the elongated splines comprises a shape memory material and an interactive element disposed on a distal portion of the respective spline, wherein each of the elongated splines comprises a respective spline proximal end and a spline distal end, wherein each of the spline proximal ends is connected to the catheter shaft distal end, and wherein each of the spline distal ends is connected to the distal hub; and
a deflection control member connected to the distal hub, wherein the control mechanism is drivingly coupled to the distal hub via the deflection control member and operable to selectively vary a position of the distal hub relative to the catheter shaft distal end to selectively vary an amount of expansion of the expandable structure, wherein a shape of the expandable structure is produced via a combination of the shape memory material and the position of the distal hub relative to the catheter distal end,
wherein the expandable structure transitions from a first configuration to a second configuration, wherein the first configuration is a collapsed arrangement, and the second configuration is an expanded arrangement, wherein, in the expanded arrangement, distal portions of each of the elongated splines are parallel to contact tissue such that each interactive element disposed on the distal portion of the respective spline is disposed in a plane perpendicular to a longitudinal axis of the catheter shaft.

### Claim 2 (depends on 1)

The electrophysiological catheter of claim 1, wherein the shape memory material comprises Nitinol.

### Claim 3 (depends on 1)

The electrophysiological catheter of claim 1, wherein the shape memory material causes each of the elongated splines to be self-erecting.

### Claim 4 (depends on 1)

The electrophysiological catheter of claim 1, wherein each of the interactive elements comprises an electrode.

### Claim 5 (depends on 4)

The electrophysiological catheter of claim 4, wherein each electrode comprises a ring electrode that extends completely around the respective elongated spline.

### Claim 6 (depends on 1)

The electrophysiological catheter of claim 1, wherein each spline distal end is connected to the distal hub so as to accommodate pivoting of the spline distal end relative to the distal hub.

### Claim 7 (depends on 1)

The electrophysiological catheter of claim 1, further comprising a proximal hub via which each spline proximal end is connected to the catheter shaft distal end.

### Claim 8 (depends on 7)

The electrophysiological catheter of claim 7, wherein:
the proximal hub comprises coupling features; and
each of the coupling features is configured to couple with one of the spline proximal ends.

### Claim 9 (depends on 8)

The electrophysiological catheter of claim 8, wherein each of the coupling features is shaped to accommodate one of the spline proximal ends.

### Claim 10 (depends on 1)

The electrophysiological catheter of claim 1, wherein the control mechanism comprises a movement limiter operable to prevent movement of the deflection control member relative to the catheter shaft.

### Claim 11 (depends on 4)

The electrophysiological catheter of claim 4, wherein the electrode is electrically connected to a device via a conductive electrical trace or a wire.