Hemostatic Clip Assembly With Shearable Release for Controlled Detachment
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Solution Overview
Problem
Existing endoscopic hemostatic clips face challenges in achieving efficient tissue grasping, secure locking, and reliable disconnection, which can lead to increased trauma, re-bleeding, and prolonged recovery times.
Innovation Solution
A novel hemostatic clip assembly with a proximal delivery catheter and distal clip assembly featuring a jaw assembly with orthogonal first pin, cam slots, and a release mechanism that allows for precise rotation and locking of jaw members, along with a shearable release pin for controlled disconnection.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If existing hemostatic clips are used, then basic hemostasis function is achieved, but tissue grasping efficiency and locking security are insufficient
Solution Approach 1:
The jaw members are designed to rotate about the first pin between open and closed configurations, transitioning from a static to a dynamic structure. This rotation mechanism enables secure tissue grasping while maintaining structural simplicity through controlled movement rather than complex multi-component assemblies.
Solution Approach 2:
The clip assembly is segmented into distinct functional components: jaw members for tissue grasping, a rotation mechanism with first pin for positioning, and a locking mechanism with second pin and cam slots for securing. This segmentation allows each component to perform its specific function efficiently while maintaining overall system simplicity.
2Reliability
If existing clip mechanisms are used, then basic deployment is possible, but disconnection reliability is poor
Solution Approach 1:
The release pin is designed to shear under axial force, automatically disconnecting the jaw adapter yoke from the delivery catheter without requiring manual intervention. This self-service mechanism ensures reliable disconnection while simplifying the operator's task to merely applying axial force.
Solution Approach 2:
The shearable release pin is pre-positioned and pre-loaded within the delivery system, ready to disconnect upon application of axial force. This preliminary preparation ensures that disconnection occurs reliably and predictably at the intended moment without requiring complex activation sequences.
3Object-affected harmful factors
If conventional clip designs are used, then basic hemostasis is achieved, but trauma to patient is increased
Solution Approach 1:
The jaw members feature specifically designed distal tips with localized grasping surfaces that concentrate the hemostatic action at the precise tissue site. This localized quality ensures effective hemostasis while minimizing trauma to surrounding healthy tissue through targeted rather than diffuse mechanical action.
Solution Approach 2:
The delivery catheter and release pin are temporarily introduced to deploy the clip assembly and then extracted from the patient's body. This extraction principle allows the minimally invasive delivery of the hemostatic device through small access points while removing the delivery system after deployment, minimizing ongoing trauma.
4Loss of time
If existing clip systems are used, then basic procedure completion is possible, but recovery time is prolonged
Solution Approach 1:
The deployment mechanism uses rapid axial translation of the release pin to quickly shear and disconnect the jaw adapter yoke from the delivery catheter. This rushing through of the disconnection step minimizes the time the delivery system remains in place, reducing procedural time and enabling faster patient recovery.
Solution Approach 2:
The complex manual manipulation required in conventional clip deployment is replaced by a simplified axial force application mechanism. The shearable release pin converts simple linear motion into reliable disconnection, eliminating the need for complex mechanical manipulation and reducing procedure time.
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
Enhances tissue grasping and locking, reduces trauma, minimizes re-bleeding, and facilitates quick recovery by ensuring secure clip application and easy detachment, thereby improving the efficiency and safety of endoscopic procedures.
Implementation Method 1
Each jaw member can include a proximal body portion and a distal end effector. The proximal body portion of each jaw member can include a respective cam slot configured and adapted to receive the second pin
Implementation Method 2
The release pin can be configured and adapted to shear when an axial force is applied to the release pin in a proximal direction, thereby separating the distal portion from the proximal portion
Implementation Method 3
The proximal delivery catheter can include a shaft spring between a proximal end of the distal clip assembly and the distal end of the catheter body
Data Source
AI summary
A proximal delivery catheter includes a proximal handle assembly, an elongated catheter body defining a longitudinal axis and extending distally from the proximal handle assembly, and a drive wire movably positioned within the elongated catheter body. A release pin assembly is coupled to a distal end of the drive wire. The release pin assembly including a release pin and a release pin housing positioned outward from the release pin. A shaft spring is positioned outward from the release pin housing. The shaft spring includes an annular portion wherein the release pin housing is configured and adapted to interfere with the annular portion of the shaft spring. A distal clip assembly is removably connected to the distal end of the elongated catheter body. The proximal delivery catheter is configured to transmit linear motion along and torsion about the longitudinal axis to at least a portion of the distal clip assembly.