Heart Valve Support With Expandable Anchoring for Regurgitation
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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 increased stroke volume and decreased cardiac output, as the valve leaflets fail to coapt properly.
Innovation Solution
A prosthetic valve support is implanted at the native valve, providing a structure for attaching a prosthetic valve that can be expanded to fit the native valve, allowing for the replacement of native valve functionality with a substitute check valve, and can accommodate multiple prosthetic valves over time, with adjustable anchoring elements and delivery apparatus enabling retrievability during deployment.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a prosthetic valve is implanted to replace native valve functionality, then regurgitation is reduced and cardiac output is improved, but the complexity of the device and implantation procedure increases
Solution Approach 1:
The prosthetic valve system is divided into separate components: a delivery catheter, a self-expanding valve frame, and a valve prosthesis. This segmentation allows for simplified implantation where each component performs a specific function, reducing overall system complexity while maintaining reliability.
Solution Approach 2:
The valve prosthesis is nested within the delivery catheter in a compressed state, and the self-expanding frame is nested within the catheter. During implantation, the catheter is positioned and the valve is deployed by expanding the frame, which then holds the prosthesis in place. This nesting approach simplifies the implantation procedure while ensuring reliable valve function.
2Adaptability or versatility
If the prosthetic valve is made expandable to fit the native valve, then adaptability to different valve sizes is improved, but the device complexity increases
Solution Approach 1:
The valve frame is designed with shape-memory material properties that allow it to change its physical parameters (size and shape) in response to environmental conditions. The frame can be compressed to a small size for delivery through catheters, then automatically expands to the appropriate size when exposed to body temperature and physiological conditions, providing adaptability without complex adjustment mechanisms.
Solution Approach 2:
The valve system transitions from a static compressed state during delivery to a dynamic self-expanding state upon implantation. The frame's ability to dynamically change size and shape allows it to adapt to different native valve dimensions without requiring multiple sized devices or complex adjustment mechanisms.
3Reliability
If anchoring elements are added to secure the prosthetic valve, then reliability of valve placement is improved, but the device complexity and potential harm to native tissue increases
Solution Approach 1:
The self-expanding frame's radial force, which could potentially damage native tissue, is converted into a beneficial anchoring mechanism. The frame expands to a predetermined size that provides gentle radial pressure against the native valve annulus, securing the prosthetic valve in place without requiring separate anchoring elements that would increase tissue damage risk.
4Ease of operation
If the prosthetic valve is designed for easy implantation and retrieval, then ease of operation is improved, but the reliability of long-term valve function may be compromised
Solution Approach 1:
The valve frame is pre-configured with shape-memory properties and a predetermined expanded shape before implantation. During delivery, it is compressed within the catheter, and upon deployment, it automatically returns to its pre-programmed expanded configuration, ensuring proper positioning and function without requiring complex adjustment procedures that could compromise long-term reliability.
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.