Medical Device Strain Relief with Composite Overlay

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Solution Overview

Problem

Existing strain relief members for medical devices are inadequate in preventing bending, kinking, or separation at the handle junction, leading to loss of device function during medical procedures.

Innovation Solution

A strain relief member with a support having a first and second outer diameter, an inner surface facing a support lumen, and an outer surface with an overlay and liner, where the overlay is more flexible than the support material, and a connector is disposed over the support to enhance pushability, torqueability, and prevent damage.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If a strain relief member is made with a rigid support structure to prevent bending and kinking, then device protection is improved, but device flexibility and torqueability deteriorate

Engineering Contradiction:

Improvedevice protectionVSAvoiddevice flexibility

Core Design Contradiction:

ReliabilityVSEase of operation

Solution Approach 1:

The strain relief member uses a composite structure with an inner support made of rigid material (e.g., nitinol, stainless steel, or polymer) and an outer overlay made of flexible material (e.g., PEBAX, polyurethane, or silicone). This composite construction allows the rigid support to prevent bending and kinking while the flexible overlay maintains device flexibility and torqueability for steering.

Inventive Principle:

Principle #40Composite materials

Solution Approach 2:

The outer overlay acts as a flexible shell that covers the rigid support structure. This flexible overlay allows the device to bend and rotate for steering while the underlying rigid support prevents excessive deformation and kinking, resolving the contradiction between protection and flexibility.

Inventive Principle:

Principle #30Flexible shells and thin films

2Reliability

If a strain relief member is made with a rigid support structure to prevent separation at the handle junction, then device integrity is improved, but pushability deteriorates

Engineering Contradiction:

Improvedevice integrityVSAvoidpushability

Core Design Contradiction:

ReliabilityVSForce

Solution Approach 1:

The composite structure with rigid support and flexible overlay allows the rigid support to prevent separation at the handle junction while the flexible overlay transmits longitudinal forces effectively, maintaining pushability without compromising device integrity.

Inventive Principle:

Principle #40Composite materials

Data Source

PatentUS11724066B2Strain relief and methods of use thereof

Publication Date: 2023.08.15 COOK MEDICAL TECHNOLOGIES LLC

AI summary

The present embodiments provide strain relief members for a medical device delivery system, methods of use thereof, and methods of manufacturing. In one embodiment a strain relief member may include a support having a first end with a first outer diameter, a second end having a second outer diameter, an inner surface facing a support lumen that extends axially through the support along a longitudinal axis, and an outer surface opposite to the inner surface. An embodiment may also include an overlay coupled to a portion of the outer surface of the support, where the overlay comprises a first material and the support comprises a second material, and the first material is more flexible than the second material. A liner may be disposed in a portion of the support lumen and a first connector disposed over a portion of the support.