Variable Cross Section Medical Device Body

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Solution Overview

Problem

Implantable medical devices with varying cross sections face challenges in minimizing delamination and shearing at exterior surfaces, which can lead to device failure and exposure of filler material to patient tissue.

Innovation Solution

The implementation of a composite structure with a packing portion containing an insert, where the insert provides increased thickness and is encapsulated by packing plies, minimizing the risk of delamination and shearing, and a radiopaque coating for improved imaging visibility.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Shape

If a graduated layered arrangement with smaller lengths of plies is used to achieve varying thickness, then the desired thickness at specific locations is achieved, but shearing or delamination occurs at the exterior facing surface

Engineering Contradiction:

Improvevarying thicknessVSAvoiddelamination resistance

Core Design Contradiction:

ShapeVSReliability

Solution Approach 1:

The device is divided into distinct structural segments: a first portion forming the exterior facing surface with substantial ply coverage, and a packing portion containing the insert. This segmentation allows the exterior surface to maintain full ply coverage for delamination resistance while the packing portion provides the necessary thickness variation through the insert structure.

Inventive Principle:

Principle #1Segmentation

Solution Approach 2:

The insert is nested within the packing portion, which itself is part of the overall device structure. This nested arrangement allows the insert to provide localized thickness increase without exposing its edges at the exterior surface, thereby preventing shearing and delamination while achieving the desired varying thickness profile.

Inventive Principle:

Principle #7Nested doll (Nesting)

2Strength

If filler material is used in the composite structure, then strength and flexibility are improved, but exposure of filler material to patient tissue occurs due to delamination

Engineering Contradiction:

Improveload bearing strengthVSAvoidtissue exposure to filler material

Core Design Contradiction:

StrengthVSObject-affected harmful factors

Solution Approach 1:

The exterior facing surface is constructed with substantial coverage by complete plies in the first portion, creating a protective barrier before the device is implanted. This preliminary protective structure prevents filler material exposure to tissue by ensuring that the exterior surface maintains full ply coverage, eliminating the need for post-implantation corrections.

Inventive Principle:

Principle #10Preliminary action

3Reliability

If complete plies are used throughout the device, then delamination is minimized, but the ability to achieve varying cross section is reduced

Engineering Contradiction:

Improvedelamination resistanceVSAvoidcross section variation

Core Design Contradiction:

ReliabilityVSAdaptability or versatility

Solution Approach 1:

Different regions of the device are assigned different structural qualities: the first portion has complete ply coverage for delamination resistance, while the packing portion contains an insert for thickness variation. This local differentiation allows each region to optimize its function without compromising the other, achieving both reliability and adaptability.

Inventive Principle:

Principle #3Local quality

Data Source

PatentUS11040505B2Medical device

Publication Date: 2021.06.22 INVIBO COMPONENT MFG LTD

AI summary

The invention relates to an implantable medical device having a body comprising a composite material. The body has a variable cross section along a length, a first portion which forms a part of a surface of said body, and a packing portion. An insert is provided in the packing portion for providing an increased thickness to at least a part of the body.