Implantable Sphincter Device with Threshold-Responsive Expansion
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Solution Overview
Problem
Gastro Esophageal Reflux Disease (GERD) often results from the deterioration or inadequate functioning of the lower esophageal sphincter (LES), leading to stomach contents refluxing into the esophagus, causing discomfort and potential damage, for which existing treatments are inadequate in preventing reflux while allowing normal physiological functioning.
Innovation Solution
An implantable device is designed to be positioned around or adjacent to the LES, applying a static force and expanding only when a radially outward force exceeds a threshold, thereby preventing reflux while allowing food passage, and promoting scar tissue growth to enhance sphincter function.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a rigid sphincter reinforcement device is used to prevent reflux, then reflux prevention is improved, but normal physiological expansion and food passage are restricted
Solution Approach 1:
The implantable device transitions from a static rigid structure to a dynamic flexible structure that can change its mechanical properties in response to physiological conditions. The device expands from a compressed delivery state to a deployed state that applies radial force, and can dynamically adjust to accommodate food passage while maintaining reflux prevention through its flexible membrane structure
Solution Approach 2:
The device employs a flexible membrane or thin film structure that can deform and expand radially outward to apply controlled force on the sphincter tissue. This flexible shell maintains structural integrity for reflux prevention while allowing the necessary deformation for normal physiological functions including food passage and sphincter relaxation
2Reliability
If continuous radial force is applied to maintain sphincter closure, then reflux prevention is improved, but normal sphincter relaxation and food passage are inhibited
Solution Approach 1:
The device provides periodic or cyclical radial force rather than continuous constant force. The flexible membrane structure allows the radial force to fluctuate naturally with physiological movements, providing reinforcement during reflux-prone periods while allowing relaxation during normal swallowing and food passage, creating a rhythmic pattern of support that matches physiological needs
3Reliability
If the device structure is made complex to promote scar tissue growth, then sphincter function improvement is enhanced, but device manufacturing and implantation difficulty increase
Solution Approach 1:
The device incorporates a porous or microporous membrane structure that facilitates tissue ingrowth and scar tissue formation. The porous architecture provides a scaffold for fibroblast migration and collagen deposition, promoting beneficial scar tissue growth that reinforces the sphincter while maintaining a relatively simple overall device geometry that is amenable to manufacturing and implantation
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 device effectively prevents reflux by applying a controlled static force and expanding only under necessary conditions, while promoting scar tissue growth to improve sphincter function and durability.
Implementation Method 1
a portion of one or more of the plurality of pliable bodies adjust radially outward in a stressed configuration in response to a radially outward force acting on the one or more of the plurality of bodies
Data Source
AI summary
A medical device may include an implantable device for treating a body tissue structure. The implantable device may include a plurality of bodies spaced from adjacent bodies and arranged so as to be configured to extend around an exterior surface of a body tissue structure. The bodies may be configured to apply a static force to the body tissue in a relaxed state and may adjust or move in response to a radially outward force above a threshold level that is acting on one or more of the bodies. The bodies may be pliable and/or made with a pliable material. The bodies may be interconnected via interconnecting regions. One or more of the bodies may be configured to articulate so as to conform to movement of a body tissue structure. A skeletal component may or may not extend through one or more of the plurality of bodies.