Elastic Patch Valve Assemblies for Implantable Prostheses
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Solution Overview
Problem
Current implantable prostheses and tissue expanders face challenges with leaky valves, large and palpable designs, and limited adjustability, particularly in facilitating the addition and removal of solutions both before and after implantation, necessitating a need for low-profile, minimally palpable, and highly leak-resistant valve assemblies.
Innovation Solution
The implementation of a valve assembly comprising two elastic patches with a less elastic plug between them, creating a bonded and unbonded area, allows for the passage of a filling tube for inflation and deflation, with the plug causing stress to close the openings when the tube is removed, enhancing sealing efficacy through fluid pressure.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a traditional valve assembly is used in implantable prostheses, then the implant can be filled with solution, but the valve becomes large and palpable, compromising cosmetic appearance
Solution Approach 1:
The valve assembly utilizes thin elastic patches as the primary structural component. These flexible film structures replace traditional bulky valve mechanisms, achieving both leak resistance and a low profile that is minimally palpable under the skin. The elastic patches can deform elastically to control fluid flow while maintaining a thin overall structure.
Solution Approach 2:
The invention changes the physical parameters of the valve structure by using materials with specific elastic properties and configuring the bonding patterns (bonded versus unbonded regions) to achieve the desired balance between sealing effectiveness and profile height. The elastic modulus and thickness of the patches are optimized to provide adequate sealing while maintaining a low profile.
2Reliability
If the valve pathway is permanently closed after tube removal, then leakage is prevented, but adjustment of the implant becomes impossible
Solution Approach 1:
The valve assembly provides dynamic functionality through the elastic patches that can reversibly deform. The unbonded regions allow the patches to flex and return to their original state, enabling the valve to open and close repeatedly. This dynamic behavior allows the implant to be filled, adjusted, and refilled multiple times while maintaining leak resistance when closed.
Solution Approach 2:
The elastic patches automatically seal the valve opening through their inherent elasticity when the filling tube is removed, without requiring additional sealing mechanisms or permanent closure procedures. The material's elastic recovery provides the sealing action, and the same elastic property allows the valve to reopen when the tube is reinserted for adjustments.
3Ease of operation
If elastic patches with unbonded regions are used to allow movement, then the valve can open and close, but fluid leakage may occur through the unbonded area
Solution Approach 1:
The valve assembly is segmented into bonded regions (for structural integrity and sealing) and unbonded regions (for flexibility and operation). This segmentation allows different portions of the elastic patches to perform different functions: the bonded areas prevent leakage while the unbonded areas enable the mechanical motion required for valve operation.
Solution Approach 2:
Different regions of the valve assembly have different bonding characteristics tailored to their specific functions. The local bonding pattern is optimized so that areas requiring sealing are bonded while areas requiring movement remain unbonded. This spatial variation in bonding quality enables simultaneous achievement of leak resistance and operational flexibility.
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
This configuration provides a leak-resistant, minimally palpable, and easily adjustable valve system that allows for solution addition and removal before and after implantation, ensuring effective sealing and tissue expansion.
Implementation Method 1
a valve assembly that closes the opening in the implant shell. The valve assembly has a first elastic patch and a second elastic patch
Implementation Method 2
At least one of the planar members is sufficiently flexible to close the normally open channel is response to fluid pressure from within a fluid filled implant
Data Source
AI summary
An expandable implant includes an implant shell having an opening and a valve assembly closing the opening. The valve assembly has a first elastic patch, and a second elastic patch juxtaposed with the first elastic patch. A major face of the first elastic patch opposes a major face of the second elastic patch, and the opposing major faces have a bonded area in which the opposing faces are joined together and an unbonded area in which the opposing faces are not joined together and are free to move away from one another. A plug is disposed between the opposing major faces. A first opening extends through the first elastic patch and a second opening extends through the second elastic patch. The first and second openings are offset from one another and the unbonded area defines an elongated channel extending between the first and second openings.