Control Module Guidewire Axial Movement Cardiac Valve
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Solution Overview
Problem
Current minimally invasive cardiac valve replacement procedures face challenges in managing guidewires during catheter deployment, risking inadvertent patient injury and requiring complex handling to prevent premature deployment or retraction issues.
Innovation Solution
A delivery system with a control module that transitions between states to allow or prevent axial movement of the guidewire relative to the catheter tip, ensuring safe and controlled deployment of a radially expandable stent frame and prosthetic heart valve, featuring a handle with actuator mechanisms and safety features for precise control.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If a guidewire is utilized to guide the catheter during delivery, then the catheter can be accurately positioned at the desired location, but inadvertent injury to the patient may occur during advancement and deployment due to uncontrolled guidewire movement
Solution Approach 1:
A control module is introduced as an intermediary device between the guidewire and the catheter tip. This control module includes a receptacle that receives the guidewire and a tip that contacts the guidewire, creating a controlled interface that allows the guidewire to guide the catheter while preventing uncontrolled movement and potential injury to the patient.
Solution Approach 2:
The control module provides real-time feedback control of the guidewire relative to the catheter tip during advancement and deployment. The module detects guidewire movement and adjusts the interaction between the guidewire and catheter to maintain safe operational parameters, preventing inadvertent injury while preserving positioning accuracy.
2Productivity
If the catheter is advanced over the guidewire to deploy the prosthesis, then the prosthesis can be delivered to the target site, but complex handling is required to prevent premature deployment or retraction issues
Solution Approach 1:
The control module merges the guidewire control function with the catheter tip structure. By integrating the receptacle and tip mechanisms directly into the catheter assembly, the system reduces the number of separate components and simplifies the handling requirements while maintaining the ability to deliver the prosthesis efficiently.
Solution Approach 2:
The control module enables self-regulating interaction between the guidewire and catheter during deployment. The mechanical interface automatically controls guidewire movement relative to the catheter tip based on the deployment stage, reducing the need for complex manual handling and preventing premature deployment or retraction issues.
3Reliability
If the control module prevents axial movement of the guidewire relative to the tip, then patient safety is improved, but the flexibility in guidewire manipulation is reduced
Solution Approach 1:
The control module implements dynamic control of guidewire movement rather than static restriction. The receptacle and tip mechanism allows controlled movement during specific phases of deployment while preventing movement during critical phases, providing both safety and operational flexibility through stage-dependent freedom of movement.
Data Source
AI summary
A guidewire is coupled to a control module and extends through a lumen of the control module. The control module operates to transition between a first control state wherein the control module allows movement of the guidewire relative to a catheter and a second control state wherein relative axial movement between the catheter and guidewire is prevented.