Heart Valve Leaflet Clamping With Fixed-Point Arm Pulling
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Solution Overview
Problem
Ischemic heart disease causes regurgitation of heart valves due to papillary muscle dysfunction and ventricular dilation, leading to decreased cardiac output and atrial volume overload.
Innovation Solution
A prosthetic valve support is implanted at the native valve, providing a platform for transluminal placement of prosthetic valves, which can be coupled to the native valve using tissue-engaging elements like anchors or clips, allowing for adjustable expansion and replacement of native valve functionality.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a prosthetic valve support is implanted to replace native valve functionality, then blood flow regulation is improved and regurgitation is reduced, but device complexity increases due to the need for tissue-engaging elements and adjustable expansion mechanisms
Solution Approach 1:
The prosthetic valve is nested within the prosthetic valve support structure, with the valve positioned inside the support's opening. This nesting approach allows the valve to be contained and secured by the support while maintaining a relatively simple overall structure that addresses regurgitation effectively.
Solution Approach 2:
The prosthetic valve support is implanted and positioned against the native valve annulus before the prosthetic valve is deployed within it. This preliminary placement establishes the structural framework and securing mechanism in advance, simplifying the subsequent valve deployment process while ensuring reliable blood flow regulation.
2Reliability
If tissue-engaging elements like anchors or clips are used to couple the prosthetic valve to the native valve, then the prosthetic valve is securely anchored and regurgitation is prevented, but the difficulty of detecting and measuring increases due to the complex anchoring mechanisms
Solution Approach 1:
The prosthetic valve support acts as an intermediary structure between the native valve annulus and the prosthetic valve. It provides a simplified interface for anchoring through tissue-engaging elements while maintaining secure coupling, thereby reducing the complexity of directly anchoring the valve to the native tissue.
Solution Approach 2:
The anchoring function is segmented into separate tissue-engaging elements (anchors or clips) that are distinct from the valve itself. These elements can be independently positioned and secured to the native valve annulus, simplifying the overall anchoring process while ensuring reliable valve fixation.
3Adaptability or versatility
If the prosthetic valve support is designed to accommodate multiple prosthetic valves over time, then adaptability is improved, but device complexity increases due to the need for multiple openings and coupling mechanisms
Solution Approach 1:
The prosthetic valve support is designed with universal characteristics that allow it to accommodate multiple different prosthetic valves over time. The support structure provides standardized openings and coupling mechanisms that can interface with various valve designs, enhancing adaptability without requiring completely different support structures for each valve type.
Solution Approach 2:
The prosthetic valve support incorporates dynamic features such as expandable or adjustable openings that can adapt to different valve sizes and configurations. This dynamic capability allows the same support structure to accommodate multiple valves with varying dimensions, improving versatility while maintaining a relatively simple base design.
Data Source
AI summary
First and second atrial arms and first and second ventricular arms are advanced to the heart. The first ventricular arm is moved distally by applying a pulling force to the first ventricular arm at a first fixed connection point that is at a portion of the first ventricular arm that is farthest from a first articulation site of the first atrial arm and the first ventricular arm, and the second ventricular arm is moved distally by applying a pulling force to the second ventricular arm at a second fixed connection point that is at a portion of the second ventricular arm that is farthest from a second articulation site of the second atrial arm and the second ventricular arm. Subsequently, the first native leaflet is clamped between the first arms, and the second native leaflet is clamped between the second arms. Other embodiments are also described.