Compressible Tissue Anchor With Nitinol Basket and Spring
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Solution Overview
Problem
Conventional surgical methods for treating morbid obesity, such as gastrointestinal reduction systems, face challenges including tissue necrosis from over-compression, inadequate tissue engagement, and the need for precise force application, especially when deploying anchors transesophageally, where existing anchors may not securely engage the muscularis or serosa layers and can cause tissue damage or slippage.
Innovation Solution
A reconfigurable 'basket'-type tissue anchor with configurable struts or legs, made from shape memory alloys like Nitinol, that self-expands upon deployment to minimize contact with tissue, allowing for adjustable tensioning to maintain constant force against tissue movements while preventing over-compression, and features like frictional regions or spring members to ensure optimal deflection ranges and prevent tissue damage.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If conventional anchors are deployed to engage tissue, then tissue securement is achieved, but tissue necrosis occurs due to over-compression
Solution Approach 1:
The anchor is designed with a compressible body that can dynamically adjust its compression level. The anchor transitions from a compressed delivery state to an expanded anchoring state, allowing it to adapt to tissue movements and maintain securement without causing necrosis through excessive static compression.
Solution Approach 2:
The anchor's physical parameters (volume, surface area, compression level) are changed during deployment. The body starts compressed for delivery, then expands to engage tissue, and can further adjust its compression state to maintain optimal force application while preventing tissue damage.
2Strength
If anchors are made stronger to withstand tissue movement, then anchoring reliability improves, but the risk of over-compression and tissue damage increases
Solution Approach 1:
The anchor incorporates a spring member that provides dynamic force adjustment. The spring can compress under tissue movement, allowing the anchor to maintain strong anchoring while absorbing excess force to prevent tissue damage. This elastic component enables the anchor to be strong yet compliant.
Solution Approach 2:
The spring member acts as a pre-designed cushioning mechanism that absorbs excess compression forces before they can be transmitted to the tissue. This beforehand cushioning protects the tissue from damage while maintaining the anchor's anchoring strength.
3Length of moving object
If the anchor body is compressed for delivery, then device profile is reduced, but the anchor cannot engage tissue effectively
Solution Approach 1:
The anchor body is designed to be compressible rather than rigid. During delivery, the anchor is compressed to a low profile for easy passage through the esophagus. Upon deployment, the anchor expands to its full size to engage the muscularis and serosa layers, achieving effective tissue engagement only when needed.
Solution Approach 2:
The anchor components are nested within each other in a compressed state for delivery, with the spring member and body folded into a compact configuration. Upon deployment, these nested components expand outward to engage tissue, transitioning from a compact nested state to an expanded functional state.
4Stability of the object's composition
If the anchor is made rigid to maintain constant force, then force stability improves, but the anchor cannot accommodate tissue deflection
Solution Approach 1:
The spring member provides dynamic adaptability while maintaining force stability. The spring can compress and expand in response to tissue deflection, allowing the anchor to accommodate tissue movement while maintaining relatively constant anchoring force. This dynamic mechanism balances rigidity with adaptability.
Solution Approach 2:
The spring member changes its physical parameters (compression level, force output) in response to tissue movement. When tissue deflects, the spring compresses and releases stored energy to maintain constant force. This parameter change enables the anchor to adapt to tissue deflection while maintaining stable anchoring force.
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 solution allows for secure tissue plication with reduced risk of necrosis, maintaining adequate blood flow and ensuring the anchor's force remains constant over a range of tissue deflections, thus preventing over-compression and ensuring the anchor's stability and effectiveness.
Implementation Method 1
A reconfigurable 'basket'-type tissue anchor with configurable struts or legs, made from shape memory alloys like Nitinol, that self-expands upon deployment
Implementation Method 2
features like frictional regions or spring members to ensure optimal deflection ranges and prevent tissue damage
Data Source
AI summary
Apparatus & methods for optimizing anchoring force are described herein. In securing tissue folds, over-compression of the tissue directly underlying the anchors is avoided by utilizing tissue anchors having expandable arms configured to minimize contact area between the anchor and tissue. When the anchor is in its expanded configuration, a load is applied to the anchor until it is optimally configured to accommodate a range of deflections while the anchor itself exerts a substantially constant force against the tissue. Various devices, e.g., stops, spring members, fuses, strain gauges, etc., can be used to indicate when the anchor has been deflected to a predetermined level within the optimal range. Moreover, other factors to affect the anchor characteristics include, e.g., varying the number of arms or struts of the anchor, positioning of the arms, configuration of the arms, the length of the collars, etc.