Multi-Layer Textile Needle Stop Patch for Prosthetic Shells
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Solution Overview
Problem
Conventional breast tissue expanders face challenges with needle tip damage during injection, leading to shell tearing and leaks, especially when using self-sealing shells, as existing needle guards fail to prevent penetration and minimize tip deformation under 6.5 pounds of force.
Innovation Solution
A multi-layer needle stop patch made of textile material with varying denier counts and a flexible construction that distributes force across the needle tip, preventing penetration while maintaining flexibility for easy folding and insertion, and integrating a self-sealing membrane to minimize damage and leaks.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If a single-layer needle guard material is used, then the device can be flexible and foldable for insertion, but the needle tip can penetrate through and cause shell leakage
Solution Approach 1:
The needle stop patch is constructed from multiple layers of textile material with different denier counts (e.g., 70 denier, 150 denier, 300 denier) bonded together. This composite structure combines the flexibility of lower denier layers with the penetration resistance of higher denier layers, resolving the contradiction between ease of insertion and needle tip protection.
Solution Approach 2:
The invention transitions from a single-layer material to a multi-layer construction, adding the dimension of layering to achieve both flexibility and penetration resistance. Each layer contributes different properties, creating a gradient from flexible outer layers to more resistant inner layers.
2Reliability
If a rigid needle barrier is used to prevent needle penetration, then shell leakage is prevented, but the device cannot be folded for insertion
Solution Approach 1:
The needle stop patch is made from flexible textile materials that can be folded and inserted with the implant. The multi-layer construction maintains flexibility while providing sufficient resistance to prevent needle tip penetration and subsequent shell leakage.
Solution Approach 2:
By combining multiple textile layers with varying denier counts, the patch achieves both flexibility (from lower denier layers) and penetration resistance (from higher denier layers), eliminating the need for rigid barriers.
3Reliability
If existing needle guard materials are used, then the needle can be stopped, but the needle tip becomes damaged and deformed under 6.5 pounds of force
Solution Approach 1:
The multi-layer textile construction provides a progressive cushioning effect that distributes the stopping force across multiple layers. This prevents the concentrated force that causes needle tip deformation, while still effectively stopping the needle before it reaches the shell.
Solution Approach 2:
The combination of different denier textile layers creates a progressive resistance structure that cushions the needle tip impact, distributing forces to prevent tip damage while maintaining effective needle stopping capability.
4Object-affected harmful factors
If the needle stop patch is made thick to prevent penetration, then needle tip damage is reduced, but the flexibility and ease of folding is compromised
Solution Approach 1:
The patch uses multiple layers of textile material with different denier counts bonded together. This composite structure provides sufficient thickness and penetration resistance through the combination of layers, while maintaining flexibility because each individual layer remains thin and flexible.
Solution Approach 2:
Instead of increasing the thickness of a single layer, the invention adds multiple thin layers, achieving the necessary resistance through layering rather than through increasing individual layer thickness. This maintains flexibility while providing adequate protection.
Data Source
AI summary
A prosthetic implant, such as a tissue expander, includes a silicone shell having an anterior wall and a posterior wall, and a needle stop patch secured over an inner surface of the posterior wall of the silicone shell. The needle stop patch has two or more layers of a textile material that are stacked atop one another. The textile material is flexible and includes woven threads or fiber. A bonding material bonds together the two or more layers of the textile material that are stacked atop one another. The outer edges of the respective layers are feathered for minimizing step effects between adjacent ones of the layers. A self-sealing membrane covers the anterior wall of the silicone shell. The dernier level of the textile layers increases between top and bottom layers for progressively increasing resistance tom a needle passing through the needle stop patch.