Heart Valve Delivery Catheter Safety Button for Precise Valve Release
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Solution Overview
Problem
Current heart valve delivery catheters lack precise release mechanisms, leading to inaccuracies in positioning prosthetic valves within the native annulus and potential trauma to the body channels during deployment and withdrawal.
Innovation Solution
The catheter design features a handle assembly with two rotatable control knobs and a safety button, allowing for precise control of the distal tip and staged release of prosthetic valves, along with a slotted tip and sleeves for accurate positioning and minimization of trauma.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Device complexity
If a simple delivery catheter design is used, then the device complexity is reduced, but the positioning precision of the prosthetic valve deteriorates
Solution Approach 1:
The handle assembly is divided into multiple independent control knobs (first control knob, second control knob, third control knob) that can be operated separately to control different aspects of catheter and valve positioning. This segmentation allows for precise incremental adjustments without requiring a completely complex integrated system.
Solution Approach 2:
The safety button mechanism performs preliminary locking of the control knobs at specific positions before final valve deployment. This preliminary action ensures that the catheter tip is accurately positioned and maintained at the desired location during the implantation process, improving positioning precision without requiring continuous complex control.
2Device complexity
If a simple release mechanism is used, then the device complexity is reduced, but the positioning precision of the prosthetic valve deteriorates
Solution Approach 1:
The release mechanism is segmented into multiple controlled components including control knobs and a safety button that work in sequence. The first control knob controls the distal tip position, the second control knob controls sleeve movement, and the third control knob controls valve release timing. This segmented approach provides precise staged control without requiring an overly complex integrated release system.
Solution Approach 2:
The release mechanism transitions from a static simple design to a dynamic multi-stage system where control knobs can be rotated to different positions and the safety button can be engaged or disengaged. This dynamic capability allows the operator to adjust and lock the valve at precise positions while maintaining the ability to make corrections if needed.
3Productivity
If rapid valve deployment is used, then the productivity is improved, but the trauma to body channels increases
Solution Approach 1:
The catheter tip is preliminarily positioned and locked using the first control knob and safety button mechanism before valve deployment begins. The sleeves are preliminarily positioned using the second control knob. This preliminary positioning ensures that when the valve is deployed rapidly, the catheter and sleeves are already in optimal positions, minimizing trauma to body channels during the high-speed deployment phase.
Solution Approach 2:
The deployment system transitions from a static single-speed mechanism to a dynamic system that can operate at different speeds and stages. The control knobs allow the operator to control the speed of sleeve retraction and valve deployment independently, enabling rapid deployment when appropriate while maintaining the ability to slow down or pause if trauma is observed, thus resolving the contradiction between productivity and harm reduction.
Data Source
AI summary
Valve delivery catheter assemblies including components that limit trauma to the expanded prosthetic valve and body channels as the distal tip of the catheter is withdrawn through the expanded valve and thereafter from the body. Catheter assemblies according to the present invention can include a handle assembly, an introducer sheath, and a distal tip assembly. The handle assembly can include a fixed main handle and two or more rotating handles that allow a user to control the distal tip assembly of the catheter. A safety button can be included on the handle assembly to allow for precise and consistent positioning of the prosthetic valve in the body. A valve retaining mechanism can be included to assist in retaining the prosthetic valve prior to deployment.