Radiopaque Shape-Memory Implant for LES Augmentation
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Solution Overview
Problem
Current endoscopic treatments for gastroesophageal reflux disease (GERD) fail to provide long-term augmentation of the lower esophageal sphincter (LES) and are not effective in reducing patient symptoms and esophageal acid exposure, with limitations including lack of radiopacity in implantable materials making correct placement difficult.
Innovation Solution
Implantable bulking members made of shape-memory materials like stainless steel or nitinol, which expand within the submucosa to augment the LES, and can be radiopaque for better visualization, with deployment via an endoscopic needle, and anchoring points for sutures to prevent erosion.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If implantable materials are used to bulk up and tighten the LES, then sphincter function is improved, but the materials lack radiopacity making correct placement difficult to confirm
Solution Approach 1:
The implantable material incorporates radiopaque substances that allow visualization under fluoroscopy, enabling confirmation of correct placement while maintaining the bulking function for sphincter augmentation
Solution Approach 2:
The implant combines radiopaque materials with biocompatible bulking materials to create a composite prosthesis that provides both functional augmentation and imaging visibility
2Reliability
If endoscopic suturing is used to form pleats in the LES, then acid reflux is reduced, but the plications fail over time due to lack of permanent fusion
Solution Approach 1:
The implantable material is placed in advance to provide permanent structural support and fusion, preventing the reversal of plication effects that occur with endoscopic suturing alone
Solution Approach 2:
The implantable prosthesis acts as an intermediary that maintains the plicated structure by providing permanent anchoring points and tissue fusion, preventing suture failure over time
3Reliability
If radio-frequency energy is used to create thermal lesions at the LES, then supine acid exposure is reduced, but multiple treatments are required to achieve positive results
Solution Approach 1:
The implantable material provides immediate structural support and permanent tissue fusion in a single procedure, eliminating the need for multiple sequential treatments required by radio-frequency therapy
4Object-affected harmful factors
If the implantable member is made of non-radiopaque materials, then biocompatibility is improved, but visualization during placement becomes difficult
Solution Approach 1:
The implant combines radiopaque materials with biocompatible bulking materials to create a composite prosthesis that provides both functional augmentation and imaging visibility
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 solution provides long-term augmentation of the LES, reducing acid reflux symptoms and esophageal acid exposure, while ensuring accurate placement through radiopacity and secure anchoring of sutures.
Implementation Method 1
The ability of the implantable member to assume the second configuration is due to the material properties thereof. Possible materials include using a metal, polymer, biomaterial, or composite thereof capable of holding a shape memory
Implementation Method 2
The implantable members can comprise materials of varying radiopacity, depending on requirements for radiographic imageability
Data Source
AI summary
A system and method for delivering one or more implantable members, such as metal coils, via an introducer member, such as an endoscopic needle, into a space created within the submucosal layers of the LES to augment and bulk the sphincter to improve compliance in patients with gastroesophageal reflux disease. The implantable member comprises a first substantially straightened configuration when carried by the introducer member, whereby it assumes a more curvilinear or coiled configuration following deployment such that it expands against adjacent submucosal tissue, creating a bulge at the implantation site. In another embodiment, the implantable member can serve as an anchoring port for sutures or other elements introduced for gastroplication of the LES to create tissue folds that increase sphincter compliance. The implantable members may be configured to include an external portion that interconnects with an adjacent implantable member, thereby creating tension that also increases compliance of the LES.