Tissue Anchors With Expandable Segments
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Solution Overview
Problem
Conventional surgical methods for gastrointestinal disorders, such as morbid obesity, face challenges in securely anchoring tissue folds due to the need for engaging strong tissue layers like muscularis and serosa, while avoiding complications like tissue tearing and requiring extensive training and time, especially when performed endoscopically or transesophageally.
Innovation Solution
A flexible, torqueable catheter with a tissue manipulation assembly featuring pivotable jaw members and a launch tube that articulates to grasp and secure tissue, allowing for the deployment of tissue anchors through the muscularis and serosa layers, facilitating quick and confident procedures with minimal tissue trauma.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If conventional sutures or staples are used to secure tissue, then tissue can be approximated and secured, but the device may tear through the tissue due to concentrated force over small surface area
Solution Approach 1:
The tissue anchor is designed with multiple engagement points (distal and proximal anchors) that distribute the securing force across different locations on the tissue fold, rather than concentrating force at a single staple or suture point. This segmentation of the anchoring function reduces local stress concentration and prevents tissue tearing.
Solution Approach 2:
The tissue anchor transitions from a two-dimensional staple/suture approach to a three-dimensional deployable structure that engages tissue at multiple depths and orientations. The expandable anchor body distributes force across a larger volumetric space within the tissue, reducing surface stress and preventing tear-through.
2Object-affected harmful factors
If anchors are placed transesophageally to avoid invasive surgery, then patient recovery is improved, but it becomes difficult to engage the tough stomach wall without puncturing adjacent tissue or organs
Solution Approach 1:
The tissue fold is created and positioned between the jaw members before the anchor is deployed. This preliminary folding action concentrates the tissue layers in a controlled manner, making it easier for the subsequent anchor to engage the muscularis and serosa layers without requiring forceful piercing that could damage adjacent structures.
Solution Approach 2:
The jaw members act as an intermediary device that first grasps and manipulates the tissue to create a fold, then guides the anchor deployment. This intermediary mechanism provides controlled tissue manipulation and positioning, reducing the risk of inadvertent puncture of adjacent organs while achieving proper anchor engagement.
3Object-affected harmful factors
If conventional plication procedures are performed endoscopically, then minimally invasive treatment is achieved, but the procedure requires extensive time and multiple intubations
Solution Approach 1:
The tissue manipulation assembly and anchor deployment function are merged into a single integrated catheter system. The jaw members and anchor delivery mechanism work together in one device, eliminating the need for separate intubations and procedures. This consolidation allows the entire plication and anchoring process to be completed in a single endoscopic session, reducing both procedural time and patient exposure to anesthesia.
4Reliability
If large tissue securement devices are used to prevent suture slipping, then securement reliability is improved, but the devices become unsuitable for low-profile delivery through the body
Solution Approach 1:
The tissue anchor is designed with dynamic size transformation capability. During delivery, the anchor maintains a compressed, low-profile state that fits through the catheter. Upon deployment, the anchor expands to a larger configuration that provides sufficient surface area and engagement points to prevent suture slipping. This dynamic size change allows the device to satisfy both the delivery constraint and the securement requirement.
Solution Approach 2:
The anchor structure employs a nested configuration where the distal and proximal anchor segments are positioned within each other during delivery. This nesting allows the entire anchor assembly to fit within the constrained delivery catheter profile. After deployment, the segments expand outward to create a larger, more secure anchoring structure that prevents tissue cut-through and suture slippage.
Data Source
AI summary
Methods and apparatus for securing and deploying tissue anchors are described herein. A tissue manipulation assembly is pivotably coupled to the distal end of a tubular member. A reconfigurable launch tube is also pivotably coupled to the tissue manipulation assembly, which may be advanced through a shape-lockable endoscopic device, a conventional endoscope, or directly by itself into a patient. A second tool can be used in combination with the tissue manipulation assembly to engage tissue and manipulate the tissue in conjunction with the tissue manipulation assembly. A deployment assembly is provided for securing engaged tissue via one or more tissue anchors, the deployment assembly also being configured to disengage the anchors endoluminally or laparoscopically.