Inverting Sleeve Esophageal Stent for Acid Reflux Control
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Solution Overview
Problem
Esophageal stents pose unique challenges due to the lower esophageal sphincter's inability to block stomach acid effectively after stent placement, leading to tissue damage and other complications, as existing solutions do not adequately manage the flow of materials and fluids through bodily passages.
Innovation Solution
The development of intraluminal medical devices featuring an expandable frame and a sleeve with differential wall thicknesses that can invert between extended and inverted positions, allowing for controlled flow and pressure management to prevent acid reflux while allowing food and fluids to pass through.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If a stent is placed across the lower esophageal sphincter to maintain vessel patency, then the ability to block acid entry into the esophagus is reduced, but the esophageal passage remains open for food passage
Solution Approach 1:
The device is divided into distinct functional segments: an expandable frame for structural support, a valve mechanism for flow control, and a sleeve for sealing. This segmentation allows each component to perform its specific function - the frame maintains patency while the valve and sleeve control acid reflux
Solution Approach 2:
The valve mechanism inverts its configuration based on pressure differential. Under normal conditions, the valve remains closed to block acid. When pressure exceeds a set value (such as during swallowing), the valve inverts to an open configuration, allowing food passage while maintaining the ability to seal against acid reflux
2Reliability
If the valve leaflets are reinforced in the region of co-aption to maintain sealing, then the sealing ability is improved, but the structural complexity increases
Solution Approach 1:
The sleeve has non-uniform wall thickness with a first portion having a first wall thickness and a second portion having a second wall thickness that is less than the first. This local variation in thickness provides enhanced sealing capability at the co-aptation region while maintaining overall structural integrity without excessive complexity throughout the entire device
3Adaptability or versatility
If a sleeve with differential wall thickness is used to allow inversion, then the flow control capability is improved, but the manufacturing complexity increases
Solution Approach 1:
The sleeve is designed with varying wall thickness parameters along its length, creating regions of different structural properties. This parameter variation enables the sleeve to invert in response to pressure differentials while providing controlled flow management. The differential thickness creates a natural inversion mechanism that responds to physiological pressure changes
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 intraluminal medical devices effectively manage the flow of materials and fluids, reducing acid reflux and tissue damage by inverting to accommodate food passage while maintaining a seal to prevent stomach acid entry, thus addressing the unique challenges of esophageal stenting.
Implementation Method 1
the sleeve is adapted to invert in response to a pressure differential between the proximal end and the distal end of the device
Implementation Method 2
a biasing element disposed within the frame and adapted to exert a force on the sleeve to return the sleeve to the original configuration
Data Source
Figure 1~1C
Figure 2~3B
Figure 4~5B
AI summary
Implantable medical devices are described. For example, various implantable medical devices having a sleeve with differential wall thicknesses are described. An exemplary medical device comprises a frame and a sleeve that has a first configuration where the sleeve is in an extended position and a second configuration where the sleeve is in an inverted position.