Endoscopic Tissue Anchor Deployment via Segmented Anchoring
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Solution Overview
Problem
Conventional surgical methods for gastrointestinal disorders, such as morbid obesity, face challenges including life-threatening complications, tissue tearing due to concentrated force, and the need for extensive clinician training, particularly in engaging the muscularis or serosa tissue layers for secure anchor placement, which is difficult transesophageally and requires quick and confident procedures with existing sutures or staples.
Innovation Solution
The development of endoscopic devices with tissue manipulation assemblies and needle deployment systems that allow for the deployment of tissue anchors through the muscularis and serosa layers, enabling secure tissue folding and anchoring within the gastrointestinal tract, using a steerable endoscopic access device with a flexible tubular body and a tissue manipulation end effector to form folds and deploy anchors endolumenally.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Strength
If conventional sutures or staples are used to secure tissue, then tissue anchoring can be achieved, but the force is concentrated over a small surface area causing tissue tearing
Solution Approach 1:
The tissue anchor divides the anchoring function into multiple engagement points. The anchor has multiple legs or prongs that penetrate the tissue at different locations, distributing the tensile load across multiple anchor points rather than concentrating it at a single suture or staple site. This segmentation prevents tissue tearing while maintaining strong anchoring.
Solution Approach 2:
The tissue anchor engages different tissue layers (mucosa, submucosa, muscularis, and serosa) at different depths and locations. The anchor structure is designed to interact with each layer differently, with deeper penetration into the muscularis and serosa providing primary anchoring strength, while the mucosal engagement provides additional securing. This local differentiation of engagement quality prevents surface-level tissue tearing.
2Reliability
If anchors engage the muscularis or serosa layers, then secure anchoring is achieved, but piercing the tough stomach wall risks puncturing adjacent tissue or organs
Solution Approach 1:
The tissue anchor is deployed through a controlled puncture created by a needle or trocar, which establishes a precise pathway into the stomach wall before the anchor engages the muscularis and serosa layers. This preliminary action of creating a controlled access channel allows the anchor to reach the deep tissue layers without requiring the anchor itself to pierce the tough stomach wall, thereby preventing inadvertent puncturing of adjacent organs.
Solution Approach 2:
The needle or trocar serves as an intermediary tool that facilitates anchor deployment. Instead of the anchor directly piercing the stomach wall (which would risk organ damage), the needle first creates a controlled entry point and pathway, allowing the anchor to be delivered safely to the target tissue layers without direct contact with the fragile stomach wall by the anchor itself.
3Reliability
If conventional sewing devices are used to suture the stomach wall, then tissue can be secured, but the procedure requires extensive clinician training and time
Solution Approach 1:
The tissue anchor system is designed to be self-deploying through a simple actuation mechanism. Once the anchor is positioned within the stomach lumen, the clinician activates a button or lever that automatically propels the anchor through the stomach wall and into the muscularis and serosa layers. This self-service deployment mechanism eliminates the need for complex manual suturing techniques, significantly reducing the training required while maintaining reliable tissue securement.
Solution Approach 2:
The conventional mechanical suturing process (requiring needle manipulation, knot tying, and extensive dexterity) is replaced by a spring-loaded or mechanically actuated anchor deployment system. The anchor is propelled through the tissue wall by a controlled mechanical mechanism within the device, transforming a highly skilled manual procedure into a simpler, more automated operation that requires minimal training.
4Adaptability or versatility
If multiple intubations are performed to complete procedures, then comprehensive treatment can be achieved, but the time required and patient risk increase
Solution Approach 1:
The tissue anchor device is designed to perform multiple functions within a single endoscopic session. It can create tissue folds, secure the folds with anchors, and complete the entire plication procedure through one intubation and one procedural approach. This multi-functional capability eliminates the need for multiple separate intubations and procedures, reducing total procedure time and patient risk while maintaining comprehensive treatment effectiveness.
Data Source
AI summary
An endoscopic tissue anchor deployment device includes a handle, an elongated shaft defining an internal lumen, and an end effector attached to the distal end of the elongated shaft. A tissue anchor catheter is removably inserted through the lumen of the elongated shaft, the catheter having a tissue anchor assembly that is deployable from its distal end. In some embodiments, the handle includes a pin and track assembly that define a series of handle actuation steps corresponding to deployment steps for the deployment device end effector and the tissue anchor catheter. In some embodiments, the handle includes a catheter stop member that prevents movement of the tissue anchor catheter under certain circumstances, and a handle stop member that prevents actuation of the handle under certain circumstances.