Rotational Coupling Mechanism for Mitral Valve Catheter Alignment
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Solution Overview
Problem
Current methods for deploying prosthetic heart valves, particularly in the mitral valve annulus, face challenges such as ensuring accurate alignment, avoiding turbulent blood flow, and preventing paravalvular leaks, which require precise and safe delivery systems to minimize invasiveness and complications.
Innovation Solution
A catheter assembly with a steering catheter and outer sheath that allows for flexible deflection and rotation, coupled with a coupling mechanism to control the rotation of the outer sheath, enabling precise positioning and repositioning of the prosthetic valve at the mitral valve annulus, ensuring proper alignment and deployment.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If the prosthetic valve is deployed using a fixed delivery system, then the deployment process is simpler, but the ability to reposition and precisely align the valve is reduced
Solution Approach 1:
The delivery system incorporates a dynamic coupling mechanism that can transition between locked and unlocked states, allowing the outer sheath to be rotationally coupled to the steering catheter during positioning and uncoupled during deployment. This dynamic capability enables the system to adapt between precision alignment and flexible repositioning modes.
Solution Approach 2:
The delivery system is divided into separable components including the steering catheter, outer sheath, and coupling mechanism. This segmentation allows independent manipulation of each component, enabling precise rotational control of the outer sheath relative to the steering catheter while maintaining overall system functionality.
2Ease of operation
If the outer sheath is rotationally coupled to the steering catheter, then rotational control is improved, but the ability to independently reposition components is reduced
Solution Approach 1:
The coupling mechanism provides dynamic rotational control by allowing the outer sheath to be locked at specific rotational positions relative to the steering catheter when coupled, while permitting independent movement when uncoupled. This enables the system to switch between controlled rotation and independent repositioning based on procedural needs.
Solution Approach 2:
The system changes the rotational degree of freedom parameter by transitioning the coupling mechanism between locked and unlocked states. When locked, the rotational position is controlled and maintained; when unlocked, the outer sheath can be independently repositioned without rotational constraints.
3Stability of the object's composition
If the coupling mechanism is locked during deployment, then rotational alignment is maintained, but the ability to adjust positioning is reduced
Solution Approach 1:
The coupling mechanism dynamically transitions from an unlocked state during positioning (allowing adjustment) to a locked state during deployment (maintaining alignment). This dynamic state change enables the system to provide both positioning flexibility and deployment stability as needed.
Solution Approach 2:
The coupling mechanism is locked in advance before the final deployment step to ensure rotational alignment stability is established prior to valve release. This preliminary locking action prevents unwanted rotation during the critical deployment phase while allowing all necessary positioning adjustments to be completed beforehand.
Data Source
AI summary
A delivery system for delivering an implantable medical device, such as a prosthetic heart valve, intravascularly to a target site, such as a heart valve annulus in a patient. The system includes an outer sheath, a connecting arm connected to the outer sheath, a valve cover at the distal end of the outer sheath and a steering catheter within the outer sheath. A handle is connected to the steering catheter so that rotation of the handle rotates the steering catheter. A coupling mechanism has a first condition rotationally coupling the outer sheath to the steering catheter, and a second condition in which the outer sheath is rotationally uncouple from the steering catheter.