Electroformed Pleated Catheter Tip for Flexible Tissue Contact

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Solution Overview

Problem

Existing medical catheters face challenges in achieving flexible tip portions that can reduce tissue perforation and improve contact with targeted tissue, while also being reusable and sterilizable without compromising structural integrity.

Innovation Solution

The development of catheters with electroformed pleated regions that provide enhanced bending and extensional behavior, hermetic sealing, and adjustable length, allowing for improved tissue contact and multiple uses through hydraulic or pneumatic actuation, and featuring RF ablation elements and biocompatible materials.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Area of stationary object

If a flexible tip portion is added to improve tissue contact, then contact area increases, but structural integrity and resistance to perforation may deteriorate

Engineering Contradiction:

Improvecontact areaVSAvoidstructural integrity

Core Design Contradiction:

Area of stationary objectVSStrength

Solution Approach 1:

The catheter is divided into distinct segments with different mechanical properties: a rigid proximal shaft for structural support and a flexible distal tip for tissue contact. This segmentation allows each portion to optimize its function without compromising the other.

Inventive Principle:

Principle #1Segmentation

Solution Approach 2:

Different portions of the catheter have locally optimized properties: the proximal shaft has higher stiffness for strength and pushability, while the distal tip has lower stiffness for flexibility and conformability. This local differentiation resolves the contradiction between overall structural integrity and local tissue contact capability.

Inventive Principle:

Principle #3Local quality

2Ease of operation

If electroformed pleated regions are used to enhance flexibility, then bending capability improves, but manufacturing complexity increases

Engineering Contradiction:

Improvebending capabilityVSAvoidmanufacturing complexity

Core Design Contradiction:

Ease of operationVSDevice complexity

Solution Approach 1:

The mechanical folding process is replaced with an electroforming process that directly creates the pleated geometry through controlled metal deposition on a mandrel. This substitution eliminates complex mechanical assembly steps while achieving the desired flexible structure.

Inventive Principle:

Principle #28Mechanics substitution (Replace mechanical system)

Solution Approach 2:

The electroforming process parameters (deposition time, current density, mandrel geometry) are optimized to directly produce the pleated structure with desired flexibility characteristics, transforming a potentially complex manufacturing challenge into a controllable parameter optimization problem.

Inventive Principle:

Principle #35Parameter changes

3Reliability

If hermetic sealing is implemented for reusability, then sterilizability improves, but device complexity increases

Engineering Contradiction:

ImprovesterilizabilityVSAvoiddevice complexity

Core Design Contradiction:

ReliabilityVSDevice complexity

Solution Approach 1:

The structural shaft and sealing functions are merged into a single electroformed metal construction. The hermetic seal is inherently provided by the continuous metal wall structure, eliminating the need for separate sealing components and reducing overall device complexity.

Inventive Principle:

Principle #5Merging (Combining)

Solution Approach 2:

The electroformed metal structure combines structural integrity and hermetic sealing properties in a single material system, eliminating the need for composite assemblies of multiple materials and simplifying the overall device architecture while ensuring reusability and sterilizability.

Inventive Principle:

Principle #40Composite materials

Applied Scientific Principles

This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.

Function Achieved in This Case

The catheters achieve reversible flexibility, kink-resistance, and superb electrical shielding, enabling effective tissue ablation and sensing with reduced risk of perforation, while being reusable and sterilizable, maintaining structural integrity.

Implementation Method 1

The pleats provide an improved bending or extensional behavior of the region relative to that of an equivalent unpleated region

Methodology Applied

Scientific EffectElasticity: Elasticity

Implementation Method 2

Pleats may also offer improved crush-resistance or kink-resistance

Methodology Applied

Scientific EffectStructural reinforcement through corrugation: Corrugation

Implementation Method 3

superb electrical shielding

Methodology Applied

Scientific EffectElectromagnetic shielding: Faraday Cage

Data Source

PatentUS10946166B2Device having an electroformed pleated region and method of its manufacture

Publication Date: 2021.03.16 ST JUDE MEDICAL ATRIAL FIBRILLATION DIVISION INC

AI summary

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.