Bariatric Stent with Enlarged Segment for Pyloric Function

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Solution Overview

Problem

Bariatric surgery complications, such as post-operative leaks, are challenging to treat due to existing stents being prone to migration and not adapted to the modified stomach geometry after sleeve gastrectomy, leading to increased morbidity and mortality.

Innovation Solution

A prosthesis with a single stent layer and a polymeric layer, designed to allow normal function of the pyloric sphincter, comprising a proximal stent flange, proximal stent segment, enlarged stent segment, and a connecting segment, with a polymeric cover that is resistant to degradation and occludes leaks, reducing tissue in-growth, and is self-expandable with a variable diameter.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If existing stents are used to treat leaks after sleeve gastrectomy, then leak occlusion is achieved, but the stents are prone to migration due to not being adapted to the modified stomach geometry

Engineering Contradiction:

Improvestent stabilityVSAvoidadaptability to modified stomach geometry

Core Design Contradiction:

ReliabilityVSAdaptability or versatility

Solution Approach 1:

The stent incorporates an enlarged segment with a diameter greater than other segments, creating localized geometric adaptation to the modified stomach anatomy after sleeve gastrectomy. This enlarged portion provides anchoring engagement with the gastric wall to prevent migration, while other segments maintain appropriate diameters for their respective anatomical locations.

Inventive Principle:

Principle #3Local quality

Solution Approach 2:

The stent is designed as a self-expanding structure that can dynamically adapt to the modified stomach geometry. The self-expansion mechanism allows the stent to conform to the post-surgical gastric shape while maintaining radial force for leak occlusion and providing frictional engagement to prevent migration.

Inventive Principle:

Principle #15Dynamics

2Reliability

If a stent is placed to occlude leaks, then leak sealing is achieved, but the pyloric sphincter function is impaired due to stent presence

Engineering Contradiction:

Improveleak occlusionVSAvoidpyloric sphincter function

Core Design Contradiction:

ReliabilityVSEase of operation

Solution Approach 1:

The stent is divided into multiple segments including proximal and distal flanges, proximal and distal segments, and an enlarged segment. This segmentation allows different portions of the stent to serve different functions: occluding leaks at the leak site while leaving the pyloric sphincter region sufficiently open to maintain normal physiological function.

Inventive Principle:

Principle #1Segmentation

Solution Approach 2:

The stent provides localized occlusion only where leaks occur, rather than spanning the entire gastric outlet. The enlarged segment is positioned to engage the gastric wall for stabilization without obstructing the pyloric sphincter, allowing food passage while maintaining leak sealing at specific locations.

Inventive Principle:

Principle #3Local quality

3Reliability

If multiple stents are used to treat leaks, then adequate coverage is achieved, but device complexity and treatment risk increase

Engineering Contradiction:

Improveleak coverageVSAvoidnumber of stents

Core Design Contradiction:

ReliabilityVSDevice complexity

Solution Approach 1:

Multiple stent functions are merged into a single integrated stent structure. The stent combines leak occlusion, migration prevention through enlarged segment engagement, and adequate anatomical coverage in one device, eliminating the need to deploy multiple separate stents and reducing procedural complexity and risk.

Inventive Principle:

Principle #5Merging (Combining)

Solution Approach 2:

The single stent is designed to perform multiple functions simultaneously: occluding leaks, preventing migration through enlarged segment engagement with the gastric wall, maintaining pyloric sphincter function, and providing adequate coverage of the treated area. This multi-functional design replaces the need for multiple specialized stents.

Inventive Principle:

Principle #6Universality (Multi-functionality)

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 prosthesis effectively occludes leaks and allows normal function of the pyloric sphincter, reducing the risk of complications and improving treatment outcomes for bariatric surgery patients by providing a stable and adaptive solution for the modified stomach geometry.

Implementation Method 1

a self-expandable prosthesis with a variable diameter

Methodology Applied

Scientific EffectElastic memory: Elasticity

Data Source

PatentUS9801749B2Methods allowing pyloric sphincter to normally function for bariatric stents

Publication Date: 2017.10.31 BOSTON SCIENTIFIC SCIMED INC

AI summary

A prosthesis that when implanted in the gastrointestinal tract does not impede the normal function of the pyloric sphincter. In some instances, the prosthesis is implanted as part of, or after, a sleeve gastrectomy procedure. The prosthesis includes a stent with an outer surface and a polymeric cover fully covering the outer surface of the stent. The stent includes a proximal stent flange; a proximal stent segment extending distally from the proximal stent flange; and an enlarged stent segment extending distally from the proximal stent segment.