Duodenal Sleeve with Shape Memory Alloy Anchor
Find Innovative SolutionsGenerate Solutions
Solution Overview
Problem
Current duodenal-jejunal bypass sleeves, such as the EndoBarrier, while effective for weight loss and metabolic control, face limitations in durability and long-term sealing efficacy due to materials and structural integrity issues, leading to potential complications and reduced effectiveness over time.
Innovation Solution
A gastric implant with a radially expandable distal sleeve, pyloric restriction portion, and proximal anchor, made from materials like polyethylene terephthalate (PET) and polytetrafluoroethylene (PTFE), along with an expandable framework, is designed to be implanted in the duodenum and stomach, featuring a delivery system that allows for deployment and secure fastening to the gastrointestinal tract, ensuring a continuous passageway for stomach contents and reducing nutrient absorption.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If current duodenal-jejunal bypass sleeves are used, then weight loss and metabolic control are achieved, but durability and long-term sealing efficacy deteriorate due to material and structural integrity issues
Solution Approach 1:
The sleeve is constructed using composite materials including fluoropolymer and shape memory alloy, combining the chemical inertness and biocompatibility of fluoropolymer with the superelasticity and shape recovery capabilities of shape memory alloy. This composite structure enhances both durability and long-term sealing efficacy while maintaining the weight loss and metabolic control benefits
Solution Approach 2:
The shape memory alloy framework utilizes parameter changes in response to temperature variations to transform from a compressed delivery state to an expanded functional state. This phase transition enables reliable deployment and maintains structural integrity over time, directly addressing the durability and long-term efficacy concerns
2Ease of operation
If the sleeve is made expandable from compressed delivery configuration to implanted configuration, then deployment and anchoring are improved, but device complexity increases
Solution Approach 1:
The sleeve incorporates a dynamic shape memory alloy framework that automatically transitions from compressed to expanded configuration through temperature-responsive phase change. This self-actuating mechanism simplifies the deployment process by eliminating complex mechanical actuation systems while maintaining ease of operation during implantation
Solution Approach 2:
The shape memory alloy framework performs self-service by automatically recovering its predetermined three-dimensional configuration when exposed to body temperature, eliminating the need for external actuation mechanisms. This self-deployment capability improves ease of operation while reducing overall device complexity
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 implant provides sustained weight loss and metabolic control by maintaining a sealed passageway and secure anchoring, minimizing complications and ensuring long-term efficacy through the use of durable and expandable materials.
Implementation Method 1
The distal sleeve may include an expandable framework. For example, the framework may include a shape memory alloy, such as nitinol
Implementation Method 2
the framework may include superelastic elements
Data Source
AI summary
A gastric implant includes a distal sleeve portion configured to be disposed in a duodenum of a patient, and a pyloric restriction portion connected to a proximal end of the distal sleeve portion. The pyloric restriction portion is configured to be disposed in a pylorus of a patient. Also, the implant includes a proximal anchor portion connected to a proximal end of the pyloric restriction portion. The proximal anchor portion is configured to be disposed in a lower stomach of the patient. The proximal anchor portion has at least one eyelet for fastening to the stomach to secure the implant to the gastrointestinal tract.