Tissue Anchor with Layer-Specific Engagement for GI Plication
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Solution Overview
Problem
Conventional surgical methods for gastrointestinal disorders, such as morbid obesity, face challenges in securely approximating and stabilizing tissue folds within the gastrointestinal lumen due to the limitations of existing tissue anchors, which often fail to engage the muscularis or serosa layers effectively, leading to potential tissue damage and prolonged procedure times.
Innovation Solution
A flexible, torqueable catheter-based tissue manipulation assembly with pivotable jaw members and a launch tube mechanism that allows for low-profile configuration and articulation to securely grasp and anchor tissue, enabling the deployment of tissue anchors through the muscularis and serosa layers, facilitating quick and confident tissue plication procedures.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If conventional tissue anchors are used to secure tissue folds, then tissue approximation can be achieved, but the anchors fail to engage the muscularis or serosa layers effectively, leading to potential tissue damage and unreliable anchoring
Solution Approach 1:
The tissue anchor is designed with differentiated engagement features: a first engagement feature that interfaces with the mucosa and connective tissue layers, and a second engagement feature that specifically engages the muscularis or serosa layers. This local differentiation of engagement mechanisms ensures reliable anchoring to the strongest tissue layers while minimizing damage to superficial layers.
Solution Approach 2:
The anchor is segmented into multiple engagement features distributed along its structure. The first engagement feature handles superficial tissue engagement, while the second engagement feature (positioned distally) handles deep muscularis or serosa engagement. This segmentation allows each feature to be optimized for its specific tissue layer without compromising the other.
2Productivity
If conventional surgical methods are used to approximate and secure tissue folds, then tissue approximation can be achieved, but procedure times are prolonged
Solution Approach 1:
The tissue anchor is pre-loaded onto a delivery catheter with the engagement features positioned and ready. The anchor can be rapidly deployed endoluminally without requiring time-consuming manual manipulation or multiple intubations, as all components are prepared in advance for immediate use.
Solution Approach 2:
The conventional mechanical suture or staple system is replaced with a self-contained tissue anchor that combines the approximation and securing functions in a single deployable unit. This eliminates the need for separate suturing steps and reduces procedural complexity, significantly cutting down operation time.
3Ease of operation
If conventional anchors are used to secure tissue, then tissue approximation can be achieved, but the anchors are large and unsuitable for low-profile delivery through the body
Solution Approach 1:
The tissue anchor is designed to nest within the delivery catheter during transport. The engagement features are compacted into a low-profile configuration that fits within the catheter lumen, allowing delivery through the body's natural lumens (esophagus, stomach) without requiring large external incisions or access points.
Solution Approach 2:
The anchor transitions from a compact, low-profile delivered state to an expanded, functional state upon deployment. The engagement features can be dynamically positioned and oriented as needed, allowing the anchor to achieve its full anchoring capability only after being delivered through the narrow catheter passage.
Data Source
AI summary
In apparatus and methods for rapid deployment of tissue anchors, a tissue manipulation assembly has a pivoting jaw. A needle assembly can be advanced through the launch tube across tissue received between the jaw members of the tissue manipulation assembly. Tissue anchors can be advanced through the needle assembly for securing received tissue. The tissue anchors can be positioned within a reloadable chamber of a control handle disposed outside the patient, then advanced through the needle assembly.