Self-Sealing Inflatable Prosthesis with Embedded Mesh Guard

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Solution Overview

Problem

Conventional inflatable prostheses, such as tissue expanders and breast implants, often require a valve or fill port for adjustment, which can be noticeable and difficult to locate, and lack flexible puncture-resistant materials that allow for easy insertion and expansion without leakage.

Innovation Solution

Development of inflatable prostheses with a puncturable, self-sealing anterior portion and a puncture-resistant posterior portion, using a method that involves embedding mesh segments within a silicone-based elastomeric material to create a flexible shell with a needle guard assembly that prevents puncture and allows for adjustable volume without the need for a valve, utilizing a combination of layers and materials for enhanced flexibility and resistance.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Adaptability or versatility

If a valve or fill port is used for adjustment, then volume adjustment is enabled, but the valve is noticeable and difficult to locate

Engineering Contradiction:

Improvevolume adjustment capabilityVSAvoidvalve location detectability

Core Design Contradiction:

Adaptability or versatilityVSDifficulty of detecting and measuring

Solution Approach 1:

The invention removes the traditional valve or fill port from the prosthesis structure entirely. Instead, fluid is introduced through a puncture-resistant posterior portion that seals automatically after needle removal, eliminating the need for a permanent access point that would be noticeable or difficult to locate.

Inventive Principle:

Principle #2Taking out (Extraction)

Solution Approach 2:

A needle guard assembly with puncture-resistant members acts as an intermediary mechanism. The guard allows controlled access through its puncture-resistant structure while preventing unauthorized or accidental punctures, and the self-sealing property ensures automatic closure after fluid introduction without requiring a visible valve.

Inventive Principle:

Principle #24Intermediary (Mediator)

2Strength

If rigid puncture-resistant material is used, then puncture resistance is improved, but flexibility and ease of insertion are reduced

Engineering Contradiction:

Improvepuncture resistanceVSAvoidflexibility for insertion

Core Design Contradiction:

StrengthVSEase of operation

Solution Approach 1:

The prosthesis combines multiple materials with different properties: a puncture-resistant posterior portion made from materials like silicone rubber or thermoplastic elastomers that resist needle puncture, while maintaining overall flexibility. The needle guard assembly uses puncture-resistant members (such as radially spaced slats or a mesh structure) embedded in or covered by flexible material, creating a composite structure that provides both protection and flexibility.

Inventive Principle:

Principle #40Composite materials

Solution Approach 2:

Different regions of the prosthesis have different mechanical properties. The posterior portion is specifically designed with puncture-resistant characteristics to withstand needle insertion, while other portions maintain flexibility for implantation. The needle guard assembly concentrates puncture resistance at the posterior region where needle access is expected, allowing the rest of the prosthesis to remain highly flexible.

Inventive Principle:

Principle #3Local quality

3Adaptability or versatility

If a valve is included for adjustment, then volume control is possible, but device complexity increases

Engineering Contradiction:

Improvevolume control capabilityVSAvoidvalve structure complexity

Core Design Contradiction:

Adaptability or versatilityVSDevice complexity

Solution Approach 1:

The invention extracts and eliminates the valve component entirely from the prosthesis design. Volume control is achieved through a simpler mechanism: a puncture-resistant posterior portion that allows needle insertion and automatically seals upon needle removal, reducing device complexity while maintaining volume adjustability.

Inventive Principle:

Principle #2Taking out (Extraction)

Solution Approach 2:

The prosthesis performs the sealing function automatically without requiring a mechanical valve. After needle removal, the puncture-resistant posterior portion self-seals to prevent fluid leakage, eliminating the need for complex valve mechanisms with moving parts, springs, or seals that would increase device complexity.

Inventive Principle:

Principle #25Self-service

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 solution provides adjustable volume prostheses that eliminate the need for valves, are easier to insert due to flexibility, and offer improved puncture resistance, allowing for repeated access and expansion without leakage, enhancing surgical procedures and patient comfort.

Implementation Method 1

embedding mesh segments within a silicone-based elastomeric material to create a flexible shell

Methodology Applied

Scientific EffectEmbedding:

Implementation Method 2

puncturable, self-sealing anterior portion

Methodology Applied

Scientific EffectSelf-sealing:

Implementation Method 3

puncture-resistant posterior portion

Methodology Applied

Scientific EffectPuncture resistance:

Implementation Method 4

applying a fluid elastomeric material to the molding surface with the segments positioned thereon, and allowing the elastomeric material to set

Methodology Applied

Scientific EffectCuring:

Data Source

PatentUS10765506B2Inflatable prostheses and methods of making same

Publication Date: 2020.09.08 ALLERGAN INC

AI summary

A laminate useful as a component of a medical implant, for example, useful as a component of an inflatable tissue expander. The laminate includes a base layer, an intermediate layer, and a top layer. When used as a component of a tissue expander, the laminate enables an internal chamber pressure of about 2.5 psi with an expander exterior compressive force of about 40 lbs.