Hemostatic Clip With Integrated Needle Passer
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Solution Overview
Problem
Conventional tissue closure devices are insufficient for closing certain perforations in the gastrointestinal tract during endoscopic procedures, which can lead to increased risk of perforation or require additional closure methods.
Innovation Solution
A device comprising an elongated flexible member with a capsule and a clip mechanism, where the clip has a pair of arms that can move between open and closed configurations, and a suture system that allows for tissue closure by drawing tissue portions together.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If conventional tissue closure devices are used, then the procedure is simple, but they are insufficient to close certain perforations in the gastrointestinal tract
Solution Approach 1:
The patent combines a clip mechanism and a suture system into a single integrated device. The clip includes a pair of arms that can grasp tissue while a suture extends between the arms, allowing the device to both clamp and suture the tissue opening simultaneously. This merging of functions enables reliable closure of difficult perforations that conventional single-function devices cannot seal.
Solution Approach 2:
The device performs multiple functions: the clip arms can grasp and hold tissue, the suture can pass through and tie tissue, and the capsule can be deployed and released. This multi-functionality allows a single device to handle various closure scenarios (small to medium sized openings) that would otherwise require multiple different devices, improving reliability without proportionally increasing complexity.
2Reliability
If a clip mechanism with movable arms is used, then tissue can be securely gripped, but the device structure becomes more complex
Solution Approach 1:
The pair of clip arms are movably housed within the capsule, with each arm containing internal structures (such as notches, openings, and engaging features). The needle and suture are nested within the arm structures. This nesting arrangement allows the complex gripping mechanism to be contained within a relatively compact delivery device, reducing overall structural complexity while maintaining reliable tissue grasping capability.
3Reliability
If a suture system with needle and loop is used, then tissue can be drawn together, but the device becomes more difficult to operate
Solution Approach 1:
The needle is pre-positioned within the clip arm structure, and the suture is pre-threaded through the needle and formed into a loop configuration. The engaging feature is pre-formed on the arm. When the device is deployed, these pre-positioned elements automatically align and function without requiring complex manual manipulation during the procedure. The operator simply needs to deploy the capsule and activate the clip, and the suture system automatically performs the tissue approximation function.
Data Source
AI summary
A device for treating a tissue opening includes a proximal portion including an elongated flexible member, a capsule releasably coupled to a distal end of the flexible member and including a lumen extending therethrough and a clip including a pair of arms movably housed within the capsule. A suture extending along a first one of the pair of arms and including a loop at a distal end thereof extending across an opening extending through the first one of the pair of arms. A suture grabbing element extending laterally from a second one of the pair of arms and including a hook so that, when the pair of arms are moved toward a closed configuration, the hook extends through the opening to grab the loop and draw the distal end of the suture from the first one of the pair of arms toward the second one of the pair of arms.