Polymeric Sleeve for Implantable Penile Prosthesis
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Solution Overview
Problem
Conventional implantable penile prostheses with elastic fabric sleeves are prone to wear and tear, leading to potential aneurysm risks due to weak spots formed over time, which can result in the pressurized inflation fluid escaping and causing structural failure.
Innovation Solution
An expandable polymeric sleeve made of elastic or inelastic materials with patterned fenestrations, such as molded or 3D-printed cylindrical structures with flexible ribs, is used to surround the inner inflatable body, providing improved wear resistance and preventing excessive expansion that could lead to aneurysm.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If an elastic fabric sleeve is used to surround the inner tube, then the sleeve provides initial expansion resistance and prevents excessive growth, but the fabric wears over time creating weak spots that can lead to aneurysm
Solution Approach 1:
The patent changes the material parameter from elastic fabric to elastomeric polymer, which provides both the necessary elasticity for expansion resistance and superior wear resistance. The polymer material maintains its mechanical properties over time unlike fabric that degrades, thus resolving the contradiction between initial reliability and long-term durability.
Solution Approach 2:
The patent uses a composite structure combining an inner tube with an outer elastomeric polymer sleeve, creating a multi-layer system where each layer performs its specific function. The polymer sleeve acts as a protective outer layer that resists wear while the inner tube provides structural integrity, together preventing aneurysm formation.
2Ease of operation
If the inner tube is allowed to expand freely, then the penis can achieve erection, but the tube may expand beyond desired limits causing structural failure
Solution Approach 1:
The elastomeric polymer sleeve functions as a flexible shell that conforms to the inner tube while providing controlled resistance to expansion. This flexible outer layer allows the necessary expansion for erection while simultaneously preventing over-expansion that would compromise structural integrity, thus resolving the contradiction between functionality and strength.
3Ease of manufacture
If conventional fabric sleeves are used, then the device can be manufactured with simple materials, but the fabric creates wear spots that lead to aneurysm risks
Solution Approach 1:
The patent changes the material parameter from conventional fabric to medical-grade elastomeric polymer, which eliminates the wear and tear problem inherent in fabric materials. The polymer material does not develop weak spots over time, thus eliminating the aneurysm risk while remaining manufacturable through standard medical device processes.
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 polymeric sleeve reduces the risk of aneurysm by maintaining structural integrity and preventing excessive expansion, mimicking the mechanical properties of a natural penis and offering improved durability compared to fabric-type sleeves.
Implementation Method 1
The sleeve is constructed from an elastomeric polymer and may include fenestrations... the sleeve can include a polymeric tube having flexible cylindrical sidewalls
Data Source
AI summary
The present application is generally directed to an expandable sleeve component of an implantable penile prosthesis, to a prosthesis containing the sleeve, and to related methods of preparation and use. More specifically, the present application is directed to an implantable penile prosthesis having a cylindrical polymeric (e.g., extruded, molded, etc.) sleeve for controlling cylinder expansion upon placement of the prosthesis within a corpus cavemosum and expansion during use.