Pivotable Jaw Tissue Manipulation Assembly for Securement
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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, along with inefficiencies in securing tissue folds and maintaining plications, especially when performing procedures endoscopically.
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 grasp and secure tissue, enabling the deployment of tissue anchors through the muscularis and serosa layers, facilitating quick and secure tissue plications.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Strength
If conventional sutures or staples are used to secure tissue, then tissue approximation can be achieved, but the force is concentrated over a small surface area causing tissue tearing
Solution Approach 1:
The tissue engagement member divides the tissue approximation function into multiple engagement points through its jaw members that can independently grasp and secure tissue at different locations, distributing the mechanical load across multiple contact points rather than concentrating it at a single suture or staple site
Solution Approach 2:
The tissue engagement member acts as an intermediary device between the anchoring element and the tissue, providing a distributed contact surface through its jaw members that grasp tissue at multiple points, thereby mediating the force transmission and preventing localized tissue tearing that would occur with direct suture or staple application
2Reliability
If anchors engage the muscularis and serosa layers to provide proper foundation, then secure tissue anchoring is achieved, but piercing the tough stomach wall risks puncturing adjacent tissue or organs
Solution Approach 1:
The system performs preliminary tissue engagement and approximation before final anchoring, allowing the jaw members to grasp and secure tissue folds in place before the anchoring element is deployed, thereby preparing the tissue to receive the anchor without requiring forceful piercing of the stomach wall
Solution Approach 2:
The invention replaces the traditional mechanical piercing and tearing mechanism with a grasping and securing mechanism, where the jaw members gently grasp tissue at multiple points and the anchoring element is then deployed through the engaged tissue, substituting forceful penetration with controlled engagement that reduces the risk of puncturing adjacent structures
3Productivity
If conventional sewing devices are used to suture stomach wall into folds, then tissue plication can be performed, but the procedure requires extensive time and multiple intubations
Solution Approach 1:
The system merges multiple functions into a single integrated device: the tissue engagement member with jaw members performs tissue grasping, folding, and approximation in one maneuver, eliminating the need for separate suturing steps and reducing the number of intubations required compared to conventional sewing devices
Solution Approach 2:
The tissue engagement member is designed to be self-actuating through the launch tube mechanism, where pulling the launch tube automatically deploys the jaw members into the engaged tissue, eliminating the need for manual suture tying and complex multi-step procedures, thereby significantly reducing procedure time
4Reliability
If conventional tissue securement devices such as suture anchors, twist ties, and clips are used, then suture prevention is achieved, but the devices are typically large and unsuitable for low-profile delivery through the body
Solution Approach 1:
The anchoring element is nested within the launch tube during delivery, with the jaw members collapsible or retractable into a compact configuration that fits within the endoscope shaft, allowing the device to be delivered through the body's natural lumens and then deployed at the target site where the anchoring element is released from the launch tube
Data Source
AI summary
Tissue manipulation and securement systems are described herein. A tissue manipulation assembly is pivotably coupled to the distal end of a tubular member and has a lower jaw member and an upper jaw member pivotably coupled to the lower jaw member. A reconfigurable launch tube is also pivotably coupled to the upper jaw member and is used to urge the jaw members from a low-profile configuration to an open configuration for receiving tissue. The tissue manipulation assembly 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.