Cardiac Valve Prosthesis with Detachable Delivery Support
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Solution Overview
Problem
Existing cardiac valve prostheses face issues such as size mismatch, perivalvular leaks, and instability due to balloon-expandable or self-expanding stent-like supporting frames, leading to regurgitation and accelerated wear, while bio-prosthetic valves implanted as replacements cause blood flow obstruction and require lifelong anticoagulation.
Innovation Solution
A prosthetic device with a support system that allows for precise implantation and anchoring outside the heart, using a detachable elongated shaft and actuator to maintain the prosthetic device at the native valve, minimizing regurgitation by enhancing native leaflet coaptation without tissue anchoring, and utilizing a frame with predefined kink points for reliable delivery and expansion.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a balloon-expandable or self-expanding stent-like supporting frame is used, then the prosthetic device can be delivered and deployed at the native valve, but size mismatch and perivalvular leaks occur leading to regurgitation and accelerated wear
Solution Approach 1:
The support is divided into two separable portions: a delivery portion that is removed after implantation and an implantable portion that remains to anchor the prosthetic device. This segmentation allows the device to be delivered through the vasculature while minimizing long-term complications from the delivery components remaining in place.
Solution Approach 2:
The delivery portion of the support is extracted (removed) after the prosthetic device is successfully implanted. This removes the source of potential complications from the delivery system while retaining only the necessary implantable portion for long-term stability and anchoring.
2Reliability
If the prosthetic device is implanted as a replacement valve, then valve function is restored, but blood flow obstruction occurs and lifelong anticoagulation is required
Solution Approach 1:
The device combines a prosthetic valve with a support system that anchors outside the heart, merging valve replacement functionality with extracardiac anchoring. This allows the valve to function while the support structure provides stability without obstructing blood flow paths.
Solution Approach 2:
The support acts as an intermediary structure that bridges the prosthetic valve to the vascular system for anchoring, rather than directly anchoring to cardiac tissue. This intermediary approach reduces tissue damage and avoids the need for lifelong anticoagulation while maintaining valve function.
3Reliability
If tissue anchoring is used to secure the prosthetic device, then the device is stabilized at the valve, but tissue damage occurs
Solution Approach 1:
The support system serves as an intermediary that transfers the anchoring function from the prosthetic valve to the vascular system. This eliminates direct tissue anchoring within the heart while maintaining device stability through extracardiac anchoring points.
Solution Approach 2:
By segmenting the support into delivery and implantable portions, the design separates the temporary delivery function from the permanent anchoring function. The implantable portion provides stable anchoring outside the heart, avoiding tissue damage while ensuring long-term device stability.
Data Source
AI summary
Apparatus and methods for repairing a cardiac valve, e.g., a tricuspid valve, are provided. The apparatus may include a prosthetic device coupled to an elongated support to suspend and maintain the prosthetic device within the cardiac valve. The support may include a proximal elongated shaft detachably coupled, in a delivery state, to a distal elongated shaft coupled to the prosthetic device. The proximal elongated shaft may detach from the distal elongated shaft at a detachment area within the patient responsive to actuation and components of the distal elongated shaft may lock to implant the prosthetic device and the distal elongated shaft within the patient. The prosthetic device may be formed of biocompatible material coupled to a frame, and may have prosthetic leaflets that allows blood to flow through in one direction during a phase of the cardiac cycle (e.g., diastole) but prevent blood regurgitation during the other phase (e.g., systole).