Biodegradable Endolumenal Restriction Device for Gastric Stoma
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Solution Overview
Problem
Conventional surgical methods for obesity treatment, such as Roux-en-Y Gastric Bypass and Lap Band procedures, involve incisions and general anesthesia, leading to complications, long recovery times, and a high risk of post-operative infections, and are not reversible.
Innovation Solution
A method and apparatus for creating a stoma of variable and reproducible size in a hollow organ without surgical incisions, using an implantable binding mechanism that is removable and can be adjusted or biodegradable, allowing for non-invasive gastric reduction with minimal discomfort and recovery time, and the option to reverse the treatment.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If conventional surgical methods (Roux-en-Y Gastric Bypass, Lap Band) are used for obesity treatment, then effective weight loss is achieved, but surgical incisions and general anesthesia lead to increased morbidity, mortality risks, and post-operative infections
Solution Approach 1:
The patent replaces traditional mechanical surgical interventions (incisions, implants, staples) with a biodegradable endolumenal device that achieves gastric restriction through controlled degradation. The device is inserted endoscopically without general anesthesia, substituting the mechanical surgical system with a minimally invasive approach that maintains treatment effectiveness while eliminating surgical hazards.
Solution Approach 2:
The biodegradable endolumenal device serves as an intermediary between the esophagus and stomach, creating a functional gastric pouch and stoma without direct surgical manipulation. This intermediary structure provides the necessary mechanical restriction for weight loss while avoiding direct contact with surgical instruments and anesthetic agents, thereby reducing morbidity and mortality risks.
2Reliability
If conventional surgical methods are used, then gastric restriction is achieved, but recovery time is extended and patient discomfort increases
Solution Approach 1:
The device is pre-configured with specific degradation characteristics that predictably establish gastric restriction upon insertion. The controlled biodegradation process begins immediately, creating the functional gastric pouch and stoma without requiring post-operative recovery periods for healing, thereby eliminating extended recovery time while maintaining reliable gastric restriction.
Solution Approach 2:
The device utilizes changes in material properties over time through biodegradation, transitioning from a fully functional restriction device to complete dissolution. This parameter change allows the device to provide necessary gastric restriction during the weight loss period while automatically reducing its presence and effect as treatment progresses, minimizing patient discomfort and eliminating long-term recovery concerns.
3Reliability
If conventional surgical methods are used, then permanent gastric modification is achieved, but the treatment becomes irreversible
Solution Approach 1:
The device incorporates dynamic properties through controlled biodegradation, transitioning from a permanent-appearing structure to a temporary, self-dissolving one. The degradation rate can be adjusted to match treatment duration requirements, providing the appearance of permanence during active treatment while ensuring automatic reversibility upon completion, thereby combining reliability with adaptability.
Solution Approach 2:
The biodegradable device is designed to be discarded by the body's natural metabolic processes after completing its restrictive function. The gradual degradation and elimination of the device provides automatic reversal of the treatment effect, allowing patients to return to their natural gastric function without requiring additional surgical intervention for removal or reversal.
4Ease of operation
If surgical incisions are made for obesity treatment, then access to the stomach is achieved, but the risk of post-operative infection increases
Solution Approach 1:
The patent replaces open surgical access methods with endoscopic insertion of a biodegradable device. The device is delivered through the natural gastrointestinal lumen without penetrating the skin or requiring incisions, substituting the mechanical surgical access system with a minimally invasive endolumenal approach that maintains stomach access capability while eliminating infection pathways associated with external incisions.
Data Source
AI summary
An apparatus and method for non-surgically creating a restriction in a tissue is provided where a binding mechanism (36) is inserted into the issue. This invention also relates to an apparatus for creating a stoma of variable and reproducible size in a hollow organ.