Flexible Inner Sleeve Anti-Reflux Stent Design
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Solution Overview
Problem
Conventional anti-reflux stents fail to effectively prevent stomach acids from refluxing into the esophagus while allowing food and liquids to pass, and they often face issues with tissue growth and removal.
Innovation Solution
An anti-reflux stent design featuring a flexible polymeric inner sleeve that collapses under gastric pressure to form a one-way valve, with a stent surrounding the sleeve and a coating to secure it, allowing for adjustable valve characteristics and easy removal.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a conventional anti-reflux stent is used, then it provides a basic one-way valve function, but it fails to effectively prevent stomach acids from refluxing while allowing food and liquids to pass
Solution Approach 1:
The inner sleeve is designed with specific flexibility characteristics that allow it to dynamically respond to different pressure conditions. Under normal gastric pressure, the sleeve remains flexible enough to collapse and form an effective seal preventing acid reflux. Under esophageal pressure during swallowing, the sleeve can be pushed open to allow food and liquid passage. This dynamic behavior resolves the contradiction between effective reflux prevention and ease of food passage.
Solution Approach 2:
The patent specifies particular flexibility parameters for the inner sleeve material and dimensions to optimize its performance. By carefully controlling the flexibility parameter, the sleeve can distinguish between different pressure magnitudes and directions, collapsing under gastric pressure to prevent reflux but opening under higher esophageal pressure to allow food passage. This parameter optimization resolves the contradiction between the two opposing functional requirements.
2Reliability
If the stent is secured to prevent tissue growth, then it remains stable in place, but it becomes difficult to remove if needed
Solution Approach 1:
The stent is divided into two distinct components with different surface treatments: the distal end (inner sleeve) has a coated surface that limits tissue growth and facilitates removal, while the proximal end (stent body) has a surface designed to secure the device in place. This segmentation allows each part to fulfill its specific function - stability where needed and ease of removal where needed - resolving the contradiction between stent stability and removability.
Solution Approach 2:
Different portions of the stent have different surface properties: the proximal end has characteristics that promote tissue integration and stability, while the distal end has a coated surface that prevents excessive tissue ingrowth and enables removal. This local differentiation of surface quality allows the stent to simultaneously achieve both stability during use and ease of removal when needed.
3Strength
If the inner sleeve is made thick and rigid to maintain structure, then it provides structural support, but it cannot collapse under gastric pressure to form an effective valve
Solution Approach 1:
The inner sleeve is designed with optimized flexibility parameters that balance structural support and collapse capability. The material and dimensions are carefully selected to provide sufficient strength to maintain the lumen open and support the valve structure, while simultaneously being flexible enough to collapse under gastric pressure to form an effective seal. This parameter optimization resolves the contradiction between structural strength and valve formation capability.
Solution Approach 2:
The stent system uses composite construction with the inner sleeve made from flexible polymeric material that provides both structural support and collapse capability. The combination of the rigid stent framework and the flexible coated inner sleeve creates a composite structure where each material contributes its strengths - the stent provides structural support while the flexible sleeve provides valve formation capability, resolving the contradiction between these two requirements.
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 stent effectively prevents stomach acids from refluxing while allowing food and liquids to enter the stomach, and its design facilitates easy retrieval and minimizes tissue growth, ensuring effective placement and removal.
Implementation Method 1
The distal end of the inner sleeve is flexible such that it compresses under normal gastric pressure in the stomach to prevent stomach contents from flowing back into the esophagus
Implementation Method 2
The distal end of the inner sleeve is flexible such that it compresses under normal gastric pressure
Implementation Method 3
a coating over the stent such that the stent is bonded to the inner sleeve
Data Source
AI summary
An anti-reflux stent includes an extended inner sleeve, a stent surrounding at least a portion of the inner sleeve and a coating that bonds the stent to the inner sleeve whereby the extended inner sleeve can have a cross-sectional thickness that varies along the length of the inner sleeve. The inner sleeve is made of a material having a thickness and/or flexibility such that the distal end not surrounded by the stent collapses under gastric pressure to prevent the contents of the stomach from flowing into an esophagus. Food and liquid can pass through an inner lumen of the inner sleeve to enter a stomach when desired.