Prosthetic Valve Support with Tissue-Engaging Clips
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Solution Overview
Problem
Ischemic heart disease leads to regurgitation of heart valves due to papillary muscle dysfunction and ventricular dilation, causing the valve annulus to dilate and prevent proper coaptation of leaflets, resulting in decreased cardiac output and ventricular weakening.
Innovation Solution
A prosthetic valve support system that facilitates minimally invasive implantation of a prosthetic valve at a native valve, using tissue-engaging elements like clips to couple the prosthetic valve to the native valve without eliminating its check valve functionality, allowing for either single or dual orifice configurations to maintain physiological function and enable delivery through narrow catheters.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a prosthetic valve is implanted to replace native valve functionality, then check valve functionality is improved, but the complexity of the implantation procedure increases
Solution Approach 1:
The implant system is divided into separate components: a prosthetic valve and a support structure with tissue-engaging elements. This segmentation allows the support structure to be implanted first to prepare the site, followed by the prosthetic valve, simplifying the overall procedure while ensuring reliable functionality.
Solution Approach 2:
The support structure with tissue-engaging elements is implanted in advance to prepare the implantation site and stabilize the native valve annulus before the prosthetic valve is deployed. This preliminary action ensures proper positioning and reduces procedural complexity during the main implantation.
2Stability of the object's composition
If the valve annulus is allowed to dilate due to ischemic heart disease, then the native valve structure is preserved, but proper coaptation of leaflets is prevented resulting in regurgitation
Solution Approach 1:
The support structure modifies the geometric parameters of the valve annulus by providing radial support and stabilization. This changes the dimensional stability of the annulus, preventing dilation while preserving the native valve structure and enabling proper leaflet coaptation.
Solution Approach 2:
The support structure acts as a counterbalancing element that opposes the dilatory forces on the valve annulus. By providing structural reinforcement, it counteracts the tendency of the annulus to dilate, thereby maintaining proper geometry for leaflet coaptation.
3Stability of the object's composition
If tissue-engaging elements are used to couple the prosthetic valve to the native valve, then implantation stability is improved, but the risk of tissue damage increases
Solution Approach 1:
The tissue-engaging elements are designed to engage with the native valve tissue in a self-regulating manner, where the tissue itself provides the engagement point. This self-service mechanism reduces the need for aggressive tissue manipulation while achieving stable implantation.
Solution Approach 2:
The tissue-engaging elements are designed with localized engagement features that concentrate the coupling force at specific points on the native valve tissue. This local quality approach ensures stable implantation while minimizing damage to the surrounding tissue by distributing stress locally.
Data Source
AI summary
For some applications, apparatus is provided for facilitating implantation of a prosthetic valve (150) at a native heart valve (120) of a subject, the apparatus comprising a prosthetic valve support (22), the prosthetic valve support (a) being configured to be transluminally-deliverable to the native valve and to be deployable at the native valve, and (b) comprising one or more tissue-engaging elements (24), configured to couple the prosthetic valve support to leaflets (128) of the native valve without eliminating check valve functionality of the native valve. Other embodiments are also described.