Variable Porosity Mesh for Anal Sphincter Expansion Control
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Solution Overview
Problem
Current treatments for fecal incontinence, such as artificial anal sphincters and sacral nerve stimulation, are invasive and often ineffective, with limited options for women with anatomic abnormalities, and there is a need for a minimally invasive solution that can address both incontinence and pelvic organ prolapse.
Innovation Solution
A cylindrically shaped mesh device with variable porosity and patterned strut members that can be implanted around or within the anal sphincter muscle to provide controlled expansion and restriction, promoting continence without inflatable devices, and a variable spring-sleeve implant that radially expands to allow material passage while maintaining sphincter closure.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If an artificial anal sphincter is used to treat fecal incontinence, then continence can be restored, but the procedure requires extensive dissection and has high complication rates
Solution Approach 1:
The patent uses a flexible mesh implant that can be configured in various cylindrical shapes to wrap around the anal sphincter muscle. This mesh structure provides reinforcement and support while being minimally invasive, avoiding the need for extensive dissection required by traditional artificial sphincters. The flexibility of the mesh allows it to conform to the anatomical structure and provide continuous support.
Solution Approach 2:
The implant utilizes a composite mesh structure combining different material properties to achieve both strength and flexibility. The mesh is designed with specific tensile strength to provide structural support while maintaining elasticity to accommodate natural anatomical movements. This composite approach reduces surgical complexity compared to solid artificial sphincter components.
2Ease of operation
If a subcutaneous valve is used to allow voluntary defecation, then patient control is achieved, but the device requires complex mechanical components and frequent patient interaction
Solution Approach 1:
The mesh implant provides passive, continuous support to the anal sphincter muscle without requiring active patient intervention or mechanical valve mechanisms. The reinforcement is always present, allowing the muscle to function naturally without the need for inflatable cuffs, valves, or other complex mechanical components that would require patient operation and maintenance.
3Reliability
If sacral nerve stimulation is used to treat fecal incontinence, then some patients experience improved continence, but the mechanism is unclear and it may not be appropriate for patients with anatomic abnormalities
Solution Approach 1:
The mesh implant can be configured in different cylindrical shapes and sizes to accommodate various anatomical conditions, including patients with anatomic abnormalities such as anal sphincter or levator muscle disruptions. The segmented mesh structure allows for customization to different patient needs, providing mechanical reinforcement regardless of the underlying cause of incontinence.
4Reliability
If a rigid implant is used to restrict the sphincter muscle, then continence is maintained, but natural anatomical behavior and material passage are restricted
Solution Approach 1:
The flexible mesh implant provides continuous reinforcement to maintain sphincter closure while allowing natural anatomical behavior. The mesh structure can expand and contract with physiological movements, permitting material passage while maintaining continence. This flexibility eliminates the need for inflatable devices or complicated mechanisms while preserving both closure function and adaptability.
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 mesh device and spring-sleeve implant offer a minimally invasive solution for fecal continence by mimicking natural anatomical behavior, providing variable expansion control and passive closure of the anal sphincter, effectively addressing fecal incontinence and pelvic organ prolapse with reduced complications.
Implementation Method 1
The devices and systems can include a cylindrically shaped member, such as mesh, that can include a variable porosity to control the degree of expansion of the anal canal. Pores or openings in the member can be shaped and patterned to allow for resistance to expansion (hold sphincter closed), yet also allow expansion or elongation during the passage of material through the sphincter.
Implementation Method 2
A variable spring-sleeve implant that radially expands to allow material passage while maintaining sphincter closure
Data Source
AI summary
Various embodiments of an implant system for treating fecal incontinence are provided. The devices and systems can include a mesh or like device that can include a variable porosity to control the degree of expansion of the anal canal. The mesh can be constructed at least in part of patterned strut members allowing for various geometric configurations, with varying load and tension properties for the designated portions of the device according to the needs for a particular patient application.