Shape Memory Alloy Bypass Frame Anchoring
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Solution Overview
Problem
Existing gastrointestinal bypass devices for treating type-2 diabetes and obesity are invasive and cause complications such as nausea, abdominal pain, inflammation, lumen obstruction, and device migration due to inadequate anchoring in the dynamic gastrointestinal environment.
Innovation Solution
A bypass device with a support frame and a sleeve, where the support frame has a unique configuration of frame members with varying flexibility and openings to securely anchor the sleeve in the duodenum and jejunum, inhibiting nutrient absorption, and is designed to navigate and stabilize within the gastrointestinal tract without causing damage.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a rigid anchor structure is used to securely fix the sleeve in the gastrointestinal tract, then the anchoring stability is improved, but the device causes tissue damage, inflammation, and discomfort due to the dynamic environment of the stomach and intestines
Solution Approach 1:
The patent changes the mechanical parameter of the frame from rigid to flexible by using shape memory alloy materials and designing the frame with adjustable stiffness characteristics. This allows the frame to adapt its flexibility to match the dynamic environment of the gastrointestinal tract, providing secure anchoring without causing tissue damage or inflammation.
Solution Approach 2:
The patent introduces dynamic characteristics to the anchor structure by using shape memory alloys that can change their mechanical properties in response to temperature or stress changes. The frame can transition between different stiffness states, allowing it to accommodate the peristaltic movements and volume changes in the stomach and intestines while maintaining reliable anchoring.
2Object-affected harmful factors
If a flexible anchor structure is used to accommodate the dynamic gastrointestinal environment, then tissue compatibility is improved, but the anchoring stability and resistance to device migration deteriorate
Solution Approach 1:
The patent employs shape memory alloy materials that can change their mechanical parameters (stiffness, strength) in response to external stimuli such as temperature changes. The frame can be deployed in a flexible state for navigation and then transformed into a more rigid state for stable anchoring, thus achieving both tissue compatibility and anchoring stability.
Solution Approach 2:
The patent divides the frame into multiple segments or struts that can independently flex and adapt to the gastrointestinal environment. This segmentation allows the overall structure to maintain flexibility for tissue compatibility while each segment contributes to the cumulative anchoring stability through their collective configuration.
3Strength
If the support frame is made completely rigid to maintain structural integrity, then structural strength is improved, but the device cannot navigate the tortuous and varying diameter passages of the gastrointestinal tract
Solution Approach 1:
The patent designs the support frame with dynamic characteristics using shape memory alloys, allowing it to transition between flexible and rigid states. During navigation, the frame remains flexible to conform to the tortuous gastrointestinal passages, and after deployment, it transforms to a rigid state to maintain structural integrity and support the sleeve.
Solution Approach 2:
The patent employs a nested configuration where the flexible support frame can be compressed or folded into a compact form for navigation through the delivery catheter and gastrointestinal tract. Once deployed, the frame expands to its full structural configuration, maintaining both navigation capability and structural integrity.
4Ease of operation
If the support frame is made completely flexible to navigate the gastrointestinal tract, then navigation capability is improved, but the device cannot resist peristaltic forces and maintain position against migration
Solution Approach 1:
The patent uses shape memory alloy materials that allow the frame to change its mechanical parameters dynamically. The frame navigates in a flexible state and then transforms to a more rigid state with increased resistance to peristaltic forces, achieving both navigation capability and resistance to migration.
Solution Approach 2:
The patent employs composite structures combining shape memory alloys with other materials to achieve a balance between flexibility for navigation and rigidity for resisting peristalsis. The composite material properties allow the frame to exhibit different mechanical characteristics under different conditions.
Data Source
AI summary
A liner support frame is configured to be positioned in a gastrointestinal tract of a human and to support a liner which inhibits nutrient absorption and anchor the liner in place in the gastrointestinal tract, the liner support frame includes a plurality of frame members connected to one another so that the liner support frame possesses a plurality of openings. The liner support frame includes a plurality of frame portions arranged axially and possessing different tapers.