Fixed-Jaw Endoscopic Closure Clip for Large GI Tissue Defects
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Solution Overview
Problem
Conventional endoscopic tissue closure devices are insufficient for closing certain tissue defects, particularly large tissue openings, which can increase the risk of perforating or damaging the gastrointestinal tract during aggressive interventional and therapeutic procedures.
Innovation Solution
An endoscopic clipping device with a capsule and two arms, where one arm is rigidly fixed and the other is slidably received, allowing movement between open and closed configurations to grasp and close tissue defects, featuring compliant materials and tissue-piercing elements for secure closure.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If conventional endoscopic tissue closure devices are used, then the procedure cost and trauma are reduced, but the ability to close certain tissue defects is insufficient
Solution Approach 1:
The closure device is divided into multiple arms (first arm and second arm) that can independently grasp tissue edges. Each arm can be positioned and secured separately, allowing the device to handle larger tissue defects that would be impossible to close with a single conventional clip. The capsule is segmented into multiple compartments to accommodate these separate arms and their associated gripping mechanisms.
Solution Approach 2:
The device transitions from a single-plane closure mechanism to a multi-dimensional approach. The arms can be positioned in different spatial orientations relative to each other, and the capsule can be oriented at various angles to match the geometry of the tissue defect. This allows the device to close defects of varying sizes and shapes by adjusting the spatial arrangement of the arms rather than increasing device complexity.
2Reliability
If larger tissue defects are addressed, then the closure effectiveness is improved, but the risk of perforating or damaging the GI tract increases
Solution Approach 1:
The device incorporates self-aligning features where the arms are designed to automatically position themselves at the tissue edges when inserted. The gripping surfaces are shaped to naturally engage with the tissue defect boundaries, reducing the need for precise manual positioning and minimizing the risk of perforation. The capsule itself serves as a guide and protective sheath during insertion.
Solution Approach 2:
The device includes a protective capsule that acts as a cushioning sheath during the insertion and closure process. This capsule distributes the mechanical stress across a larger area of the tissue defect rather than concentrating force at a single point, thereby reducing the risk of perforation or damage to surrounding healthy tissue.
3Adaptability or versatility
If aggressive interventional procedures are performed, then the therapeutic effectiveness is improved, but the risk of damaging the GI tract wall increases
Solution Approach 1:
The device allows for adjustable parameters including the spacing between arms, the gripping force applied by each arm, and the orientation of the capsule relative to the tissue defect. These parameters can be modified to match the specific requirements of different tissue defects, enabling effective closure while minimizing damage risk. The compliant material can be adjusted to provide appropriate flexibility and gripping characteristics.
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
Effectively closes large tissue defects by approximating tissue sides, reducing the risk of perforation and providing secure closure with minimal trauma, suitable for use in gastrointestinal procedures.
Implementation Method 1
the second arm is formed of a compliant material
Implementation Method 2
forming a superelastic Nitinol arm for a tissue clipping device
Implementation Method 3
the distal end of the first arm includes a tissue piercing member extending laterally inward toward the second arm
Implementation Method 4
an interior surface of one of the first and second arms include a hook, undercut and barb for catching a target tissue
Implementation Method 5
an interior surface of the first arm is curved so that longitudinal edges thereof extend toward the second arm to form a cupped tissue receiving pocket
Implementation Method 6
placing the mated male and female portions of the die assembly in a fluidic bath having a temperature of approximately 500° to treat the Nitinol stock
Implementation Method 7
removing the die assembly from the fluidic bath and water quenching the die assembly to set the Nitinol stock in the desired geometry
Data Source
AI summary
A device includes a capsule extending longitudinally from a proximal end to a distal end and including a channel extending therethrough. The capsule is releasably coupled to a proximal portion of the device. Device also includes a first arm rigidly fixed to the distal end of the capsule to extend distally therefrom. In addition, Device includes a second arm, a proximal end of which is slidably received within the capsule so that the second arm is movable between an open configuration, in which the second arm is moved laterally away from the first arm and a distal end of the second arm is moved distally past the distal end of the first arm, and a closed configuration, in which the second arm is moved toward the first arm and the distal end of the second arm is moved proximally toward the distal end of the first arm.