Stent Flange Reinforcement for Migration Resistance
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Solution Overview
Problem
Current stent designs for metabolic endoscopy and NOTES procedures face challenges with stent migration, particularly when used for forming an anastomosis between the stomach and jejunum, which can lead to reduced efficacy and increased complications.
Innovation Solution
The proposed solution involves a transluminal implant with a self-expanding reinforcement member disposed within the flange of the stent, which exerts a radially outward force to enhance anchoring and prevent migration. This reinforcement member can be configured with curved wires that provide additional pull-out force resistance.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Productivity
If a stent is used to create an opening between the stomach and jejunum for bypassing the pylorus and duodenum, then food flow is improved, but stent migration occurs leading to reduced efficacy
Solution Approach 1:
The flange is pre-formed with a curved wire reinforcement member that is radially disposed within the flange before deployment. This preliminary configuration ensures that when the stent is implanted, the reinforcement member immediately provides enhanced anchoring force to prevent migration, rather than requiring post-deployment adjustment or additional components.
Solution Approach 2:
The flange combines a mesh structure with a curved wire reinforcement member to create a composite construct. The mesh provides structural integrity and expansion capability, while the curved wire adds tensile strength and anchoring force, together preventing stent migration while maintaining food flow capability.
2Reliability
If the flange outer diameter is increased to improve anchoring, then migration resistance is improved, but the saddle region diameter must be larger which affects food flow
Solution Approach 1:
The stent is divided into distinct functional regions: the flange with enlarged outer diameter for anchoring, the saddle region with controlled diameter for food flow, and the mesh body for structural support. This segmentation allows each region to be optimized independently - the flange provides migration resistance while the saddle region maintains adequate food flow capacity.
Solution Approach 2:
Different regions of the stent have different geometric properties tailored to their specific functions. The flange has a large outer diameter for anchoring against migration, while the saddle region has a controlled diameter to maintain food flow. The mesh structure provides localized reinforcement where needed without compromising overall food passage capability.
3Strength
If a reinforcement member is added within the flange to prevent migration, then anchoring strength is improved, but device complexity increases
Solution Approach 1:
The curved wire reinforcement member is integrated within the flange structure, merging the anchoring function with the existing flange geometry. This unified design provides enhanced anchoring strength while avoiding the need for separate, complex reinforcement components, thereby limiting the increase in 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 use of a self-expanding reinforcement member within the stent flange significantly reduces the risk of stent migration, allowing for longer in-dwell durations and improved procedural efficacy by maintaining the anastomosis effectively.
Implementation Method 1
a self-expanding reinforcement member disposed within the flange of the stent, which exerts a radially outward force to enhance anchoring and prevent migration
Data Source
AI summary
Stents and/or implants including a reinforcement member. An illustrative transluminal implant may include an elongated tubular body extending from first end region to a second end region. The elongated tubular body may comprise a scaffolding forming a plurality of cells, a first flange adjacent to the first end region, a second flange adjacent to the second end region, and a saddle region extending between the first flange and the second flange. The saddle region may have an outer diameter less than an outer diameter of the first flange and the second flange. A reinforcement member may be disposed within a lumen of the elongated tubular body and within the first flange.