Braided Tissue Anchor Flanges for Leak-Resistant Tissue Approximation
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Solution Overview
Problem
Existing tissue anchors are either too rigid, causing tissue necrosis or adhesion, or too weak, allowing leakage and movement, and they are not easily deliverable endoscopically for various body lumens and purposes, with limited removability during and after initial implantation.
Innovation Solution
Tissue anchors formed from a woven filament braid, typically made of shape memory metals or polymers, with expandable double-walled flange structures that deploy endoscopically, providing firm attachment while minimizing tissue damage and allowing for removal, and optionally covered with membranes to prevent ingrowth.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Strength
If tissue anchors use rigid expandable cage structures to provide firm attachment, then attachment strength is improved, but tissue necrosis and adhesion risk increases
Solution Approach 1:
The patent employs a flexible membrane covering the stent structure, which distributes the attachment force across a larger tissue surface area. This flexible membrane prevents focal pressure points that would cause tissue necrosis, while still maintaining adequate attachment strength through distributed loading. The membrane acts as a cushioning layer between the rigid stent framework and the soft tissue.
Solution Approach 2:
The stent structure incorporates adjustable radial expansion parameters, allowing the device to be deployed at controlled pressure levels. By controlling the expansion ratio and final diameter, the attachment force can be optimized to achieve secure fixation without exceeding tissue tolerance thresholds that would lead to necrosis. The system allows parameter tuning between firm attachment and tissue preservation.
2Object-affected harmful factors
If tissue anchors are made too weak to minimize tissue damage, then tissue necrosis risk is reduced, but leakage and movement at penetration points increase
Solution Approach 1:
The stent is divided into multiple segmented struts or bars arranged in a lattice pattern. This segmentation allows the structure to achieve adequate overall strength through geometric configuration rather than material rigidity. Each segment can flex independently to accommodate tissue movement, preventing focal stress concentration, while the collective structure maintains attachment integrity and prevents leakage through the distributed framework.
3Strength
If tissue anchors are designed for firm attachment, then attachment strength is improved, but deliverability through small catheters becomes difficult
Solution Approach 1:
The stent structure is designed to nest within itself or within the delivery catheter during the delivery phase. The struts can be collapsed or folded into a compact configuration that fits through small catheters and endoscopic access channels. Once deployed at the target site, the stent expands to its full functional size to provide adequate attachment strength. This nested design enables minimally invasive delivery while maintaining performance.
Solution Approach 2:
The stent transitions from a static compressed state during delivery to a dynamic expanded state at the implantation site. The structure incorporates mechanical properties that allow it to be compressed for delivery and then self-expand or balloon-expand to its functional configuration. This dynamic transformation enables the device to overcome the size constraint of delivery catheters while achieving the required attachment strength in situ.
4Reliability
If tissue anchors provide permanent fixation, then attachment reliability is improved, but removability during and after implantation is limited
Solution Approach 1:
The stent incorporates preliminary engagement features such as barbs or hooks that provide immediate fixation upon deployment. These features ensure reliable attachment from the moment of expansion. For removability, the design includes complementary features like radiopaque markers for localization and accessible engagement points that allow controlled retrieval if needed. The preliminary fixation action ensures reliability, while the designed accessibility enables repairability.
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 anchors provide secure tissue approximation with minimal risk of necrosis and leakage, are deliverable through small catheters, and can be removed as needed, suitable for diverse medical procedures.
Implementation Method 1
Tissue anchors formed from a woven filament braid, typically made of shape memory metals or polymers, with expandable double-walled flange structures that deploy endoscopically
Data Source
Figure 1~3F
Figure 1A~1C
Figure 4A~5B
AI summary
Tissue anchors comprise a woven filament braid body having an elongated tubular configuration and a foreshortened configuration where proximal and distal ends of the body expand radially into doublewalled flange structures while leaving a cylindrical saddle region therebetween. The tissue anchors are deployed through penetrations between adjacent tissue layers, where the flanges engage the outer surfaces of the tissue layers and the saddle region resides within the tissue penetrations.