Self-Expanding Medical Device Handle Assembly
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Solution Overview
Problem
Current delivery systems for self-expanding medical devices face challenges in precise placement due to their design and handling mechanisms, leading to potential inaccuracies in deploying these devices during minimally invasive procedures.
Innovation Solution
A delivery system with a handle assembly that includes a deployment knob and a housing, where the self-expanding medical device is restrained between the inner catheter and outer sheath, allowing controlled expansion by withdrawing the sheath upon actuation of the knob, featuring a lock and indicator windows for precise deployment and stability through ergonomic design.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If a traditional delivery system design is used for self-expanding medical devices, then the device can be delivered through minimally invasive procedures, but the placement precision and accuracy are compromised
Solution Approach 1:
The delivery system is divided into distinct functional modules: an outer sheath for constraining the device, an inner catheter for support, a handle assembly with deployment knob for operator control, and a release mechanism. This segmentation allows each component to be optimized for its specific function while working together to achieve precise placement.
Solution Approach 2:
The handle assembly acts as an intermediary between the operator and the self-expanding medical device. It translates manual manipulation of the deployment knob into controlled movements of the outer sheath and inner catheter, providing mechanical advantage and precision control that would be difficult to achieve through direct manipulation alone.
2Ease of operation
If the outer sheath is withdrawn to allow device expansion, then the device can be deployed, but control over the deployment timing and position becomes difficult
Solution Approach 1:
The outer sheath is pre-positioned over the self-expanding medical device in a constrained state during delivery. The handle assembly maintains this preliminary configuration until the operator is ready to deploy, at which point the pre-positioned components can be released in a controlled manner to ensure accurate placement.
Solution Approach 2:
The handle assembly provides tactile feedback to the operator during the deployment process through the mechanical connection to the outer sheath and inner catheter. This feedback allows the operator to sense the resistance and movement of the components, enabling precise control over the timing and extent of sheath withdrawal and device expansion.
3Ease of operation
If the handle assembly is designed for ergonomic handling, then operator comfort is improved, but the precision of device placement may be compromised
Solution Approach 1:
The handle assembly incorporates dynamic elements such as a rotatable deployment knob and movable components that can be manipulated with minimal force. The mechanical linkage provides dynamic control, allowing the operator to make fine adjustments during deployment while maintaining an ergonomic grip position throughout the procedure.
Data Source
AI summary
A delivery system is provided for a self-expanding medical device. The delivery system has a handle assembly with a housing. The housing has a slot with a deployment knob extending therethrough. The self-expanding medical device is deployed by restraining the housing of the handle assembly and pulling on the deployment knob. This causes an outer sheath to withdraw proximally from an inner catheter to release the self-expanding medical device from a space between the outer sheath and inner catheter.