Repositionable Over-the-Scope Clip for Tissue Opening Sealing
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Solution Overview
Problem
Endoscopic procedures such as lesion removal and tunneling under the mucosal layer of the GI tract can increase the risk of intrabdominal hypertension and seeding of cancer cells, and create tissue openings that need to be hemostatically sealed.
Innovation Solution
A clipping device with a cap and inner, outer bodies, a first clip biased to a closed configuration, and control wires to manipulate the clip between insertion, closed, and reload configurations, allowing precise tissue clipping and repositioning.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a clip is deployed to close a tissue opening, then hemostatic sealing is achieved, but the clip cannot be repositioned if misplaced
Solution Approach 1:
The clip system transitions from a static deployed state to a dynamic repositionable state through the release mechanism. The clip can be held in place during positioning, then released to allow proximal movement for repositioning, and finally locked in the desired position. This dynamic behavior resolves the contradiction between reliable sealing and ease of repositioning.
Solution Approach 2:
The system allows the clip to be temporarily discarded from its initial position and recovered at a new position. The release mechanism enables the operator to discard the clip from the tissue opening, move it proximally, and reattach it at the correct location, combining reliability with repositioning capability.
2Reliability
If multiple clips are used to close large tissue openings, then complete sealing is achieved, but procedural time increases
Solution Approach 1:
Multiple clips are nested within the cap structure, with each clip stored in its own compartment. This nesting allows all clips to be delivered through a single endoscope insertion, eliminating the need for multiple separate insertions and reducing procedural time while maintaining complete sealing through multiple clips.
Solution Approach 2:
The system merges multiple clip delivery functions into a single integrated cap structure. All clips are loaded and controlled through one device, allowing sequential deployment without removing or repositioning the cap, thereby reducing procedural time while achieving complete sealing.
3Ease of operation
If the clip is held in an open configuration during insertion, then tissue access is facilitated, but the clip cannot apply clamping force until deployed
Solution Approach 1:
The clip is prepared in the open configuration during insertion, allowing tissue to be accessed and positioned. The preliminary action of opening the clip before deployment facilitates tissue access, and the subsequent deployment action then applies the clamping force to achieve sealing.
Solution Approach 2:
The clip transitions dynamically from an open low-force state during insertion to a closed high-force state during deployment. This dynamic transformation allows the system to provide tissue access when needed and apply clamping force when required, resolving the contradiction between ease of operation and force application.
Applied Scientific Principles
This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.
Function Achieved in This Case
The device enables secure and adjustable clipping of tissue openings, minimizing trauma and enhancing procedural control, suitable for closing large openings requiring multiple clips.
Implementation Method 1
The first clip is biased toward a closed configuration in which arms of the first clip are drawn toward one another to clip tissue received therebetween
Data Source
AI summary
A clipping device includes a cap having inner and outer bodies separated by a gap, a clip, a control wire extending from proximal to distal ends, and first and second sheaths. The clip is mounted on a structure and biased toward a closed configuration. The clip is received on the inner body with the arms separated to draw tissue. The first sheath receives the wire and extends to a distal end movable between insertion and extended positions. The second sheath slidably receives the first sheath and extends from a proximal end to a distal end fixed relative to the inner body. The structure extends beyond a distal end of the inner body to engage a central portion of the clip as the clip is drawn toward the cap so that the structure forces the arms apart to draw the clip into the gap.