Inflatable Prostheses With Self-Sealing Anterior and Puncture-Resistant Posterior
Find Innovative SolutionsGenerate Solutions
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 effective puncture-resistant materials for safe implantation.
Innovation Solution
The development of inflatable prosthetic implants with a puncturable, self-scaling anterior portion and a puncture-resistant posterior portion, utilizing flexible, puncture-resistant materials and a needle guard assembly with misaligned puncture-resistant members to prevent needle penetration.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Adaptability or versatility
If a valve or fill port is used for adjusting implant volume, then volume adjustability is improved, but the valve becomes noticeable and difficult to locate
Solution Approach 1:
The patent removes the traditional valve or fill port from the implant structure entirely. Instead, it uses a self-sealing membrane that allows fluid injection through a puncture made by a needle, eliminating the need for a separate valve component that would be noticeable or difficult to locate.
Solution Approach 2:
The self-sealing membrane acts as an intermediary between the implant interior and the external injection needle. It allows controlled fluid passage when punctured while automatically sealing to prevent leakage, replacing the function of a traditional valve without requiring one.
2Ease of manufacture
If conventional materials are used for implant shell, then manufacturing is simplified, but puncture resistance is insufficient for safe implantation
Solution Approach 1:
The patent employs a composite structure consisting of an inner puncture-resistant layer and an outer elastomeric layer. The inner layer provides superior puncture resistance while the outer layer provides flexibility and comfort, achieving both reliability and manufacturability through material composition rather than complex manufacturing processes.
3Reliability
If the implant is made entirely puncture-resistant, then safety is improved, but insertion and expansion becomes more difficult
Solution Approach 1:
The implant shell has different properties in different regions: the anterior portion contains a self-scaling, puncturable section that is easier to insert and expand, while the posterior portion maintains high puncture resistance for safety. This local differentiation allows both easy insertion and high safety without compromising either.
4Reliability
If a needle guard assembly with multiple layers is used, then puncture resistance is improved, but device complexity increases
Solution Approach 1:
The patent integrates the needle guard functionality directly into the posterior portion of the implant shell itself, rather than using a separate removable assembly. The misaligned puncture-resistant members are embedded within the shell structure, combining protective function with the main body to reduce overall device complexity.
Data Source
AI summary
A prosthesis can include a shell and a needle guard coupled to a posterior portion of the shell. The shell can include a laminate having a base layer, a top layer, and a soft silicone gel intermediate layer disposed between the base layer and the top layer and of sufficient thickness for self-sealing of a needle hole therethrough. The needle guard can include a plurality of offset layers of offset, puncture-resistance structures that, in an expanded state, (i) collectively form a concave shape and (ii) provide a concave exterior surface along the posterior portion of the prosthesis for approximating a human anatomical feature. The needle guard can have a shape memory characteristic for urging the prosthesis toward the expanded state.