# US 10,946,166 B2 · Device having an electroformed pleated region and method of its manufacture

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- Number: US 10,946,166 B2
- Document ID: US10946166B2
- Status: Granted
- Kind: B2
- Application number: 15/403,380
- Filed: 2017-01-11
- Published: 2017-05-25
- Granted: 2021-03-16
- Earliest claimed: 2010-12-30
- Assignees: St. Jude Medical, Atrial Fibrillation Division, Inc.
- Applicants: St. Jude Medical, Atrial Fibrillation Division, Inc.
- Inventors: John W. Sliwa; Stephen A. Morse
- Web page: https://patentgrep.com/patent/US10946166B2

## CPC

- A61M 25/001: {Forming the tip of a catheter, e.g. bevelling process, join or taper}
- A61B 18/1492: {having a flexible, catheter-like structure, e.g. for heart ablation (A61B18/1477 takes precedence)}
- A61M 25/0074: {Dynamic characteristics of the catheter tip, e.g. openable, closable, expandable or deformable}
- A61M 25/008: {Strength or flexibility characteristics of the catheter tip}
- A61M 25/0133: {Tip steering devices}
- B23K 26/389: {of fluid openings, e.g. nozzles, jets}
- C23C 28/021: {including at least one metal alloy layer}
- C23C 28/023: {only coatings of metal elements only}
- C25D 1/00: Electroforming
- C25D 1/02: Tubes; Rings; Hollow bodies
- C25D 1/20: Separation of the formed objects from the electrodes {with no destruction of said electrodes}
- C25D 3/48: of gold
- C25D 3/50: of platinum group metals
- 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 25/0155: {with hydraulic or pneumatic means, e.g. balloons or inflatable compartments}
- A61M 25/0158: {with magnetic or electrical means, e.g. by using piezo materials, electroactive polymers, magnetic materials or by heating of shape memory materials}
- B23K 2101/08: finned or ribbed
- B23K 2103/08: Non-ferrous metals or alloys
- 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)
- B23K: SOLDERING OR UNSOLDERING; WELDING; CLADDING OR PLATING BY SOLDERING OR WELDING; CUTTING BY APPLYING HEAT LOCALLY, e.g. FLAME CUTTING; WORKING BY LASER BEAM
- C23C: COATING METALLIC MATERIAL; COATING MATERIAL WITH METALLIC MATERIAL; SURFACE TREATMENT OF METALLIC MATERIAL BY DIFFUSION INTO THE SURFACE, BY CHEMICAL CONVERSION OR SUBSTITUTION; COATING BY VACUUM EVAPORATION, BY SPUTTERING, BY ION IMPLANTATION OR BY CHEMICAL VAPOUR DEPOSITION, IN GENERAL (making metal-coated products by extrusion B21C23/22; covering with metal by connecting pre-existing layers to articles, see the relevant places, e.g. B21D39/00, B23K; metallising of glass C03C; metallising mortars, concrete, artificial stone, ceramics or natural stone C04B41/00; enamelling of, or applying a vitreous layer to, metals C23D; treating metal surfaces or coating of metals by electrolysis or electrophoresis C25D; single-crystal film growth C30B; by metallising textiles D06M11/83; decorating textiles by locally metallising D06Q1/04)
- C25D: PROCESSES FOR THE ELECTROLYTIC OR ELECTROPHORETIC PRODUCTION OF COATINGS; ELECTROFORMING; APPARATUS THEREFOR

## Abstract

A deflectable, flexible device includes an elongate body, a convoluted tip portion at a distal end of the elongate body, and a lumen to receive one or more wires. The convoluted tip portion includes an electroformed pleated region which is formed by electrodepositing a metal on a mandrel having a pleated region. The convoluted tip portion may be hermetically sealed to permit repeated sterilization. The electroformed pleated region may include one or more fluid emission orifices. The convoluted tip portion extends or bends in response to fluid pressure manipulation, contact with tissue, manipulation with an internal spring or wire, or by a user pushing, pulling, or twisting the catheter directly or via an introducer sheath or the like. The convoluted tip portion may further include an RF ablation element or other energy-driven technique to create continuous linear lesions or a sensing element.

## Claims

### Claim 1

A method of manufacturing an elastically deformable pleated region of a catheter, comprising the steps of:
rendering the surface of a polymeric mandrel conductive, wherein the polymeric mandrel comprises at least one pleated region including a plurality of adjacent pleats extending perpendicular to a longitudinal axis of the mandrel, and wherein the polymeric mandrel further comprises multiple interior lumens,
electrodepositing a metal onto the at least one pleated region, thereby forming an elastically deformable electroformed pleated region including the plurality of adjacent pleats extending perpendicular to the longitudinal axis of the pleated region, wherein the elastically deformable electroformed pleated region comprises an ablation element, and wherein at least a portion of the polymeric mandrel is retained; and
coupling the elastically deformable electroformed pleated region to the distal portion of an elongate body, wherein the proximal portion of the elongate body is coupled to a control handle.

### Claim 2 (depends on 1)

The method of claim 1, wherein the metal is selected from the group consisting of nickel, copper, and gold.

### Claim 3 (depends on 2)

The method of claim 2, further comprising a step of over coating the electroformed pleated region with a gold, rhodium or platinum alloy.

### Claim 4 (depends on 1)

The method of claim 1, wherein the electrodepositing step further comprises electrodepositing the metal onto an entirety of the surface of the polymeric mandrel.

### Claim 5 (depends on 1)

The method of claim 1, further comprising a step of laser drilling irrigant fluid emission orifices in the electroformed pleated region.