Prosthetic Heart Valve Guide Rail Alignment System
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Solution Overview
Problem
Current prosthetic heart valve implantation methods are complex, time-consuming, and often result in suboptimal fit within the heart's annulus, leading to impaired blood hemodynamics, clotting, and calcification, and are not compatible with minimally invasive procedures due to the need for large access sites.
Innovation Solution
A prosthetic heart valve system comprising an annular member with a sewing cuff and guide rails that can be compressibly expanded to fit within the annulus, allowing for secure implantation and alignment with a valve prosthesis, using a delivery tool to facilitate tensioning and release of the guide rails for optimal positioning and sealing.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If conventional prosthetic heart valve implantation methods are used with sewing rings, then the valve can be implanted within the heart annulus, but the procedure becomes complex and time-consuming requiring management of many sutures
Solution Approach 1:
The prosthetic valve system is divided into separate components: a valve prosthesis and a separate annular prosthesis (sewing ring). This segmentation allows each component to be optimized independently and simplifies the implantation process by separating the valve replacement function from the anchoring function.
Solution Approach 2:
Guide rails are introduced as intermediary elements that extend from the annular prosthesis to guide the valve prosthesis into proper alignment and positioning. These guide rails act as mediators between the two prosthesis components, ensuring accurate placement without requiring complex suture manipulation.
2Adaptability or versatility
If the sewing ring is made flexible to conform to the annulus anatomy, then better anatomical fit is achieved, but the valve and sewing ring may not mate together effectively
Solution Approach 1:
The annular prosthesis is designed with dynamic characteristics, allowing it to be compressed to a smaller diameter for delivery and then expand to its native size upon deployment. This dynamic behavior enables the prosthesis to adapt to the annulus anatomy while maintaining structural integrity for reliable valve mating.
Solution Approach 2:
The guide rails are pre-attached to the annular prosthesis before implantation. This preliminary action ensures that when the valve prosthesis is delivered, it automatically aligns with the pre-positioned guide rails, guaranteeing effective mating between the valve and sewing ring components.
3Reliability
If the heart is accessed by sternotomy or thoracotomy to introduce prosthetic heart valve, then the valve can be implanted, but the procedure is not compatible with minimally invasive approaches
Solution Approach 1:
The annular prosthesis and valve prosthesis are designed to be nested together during delivery. The valve prosthesis is delivered over the guide rails that extend from the annular prosthesis, allowing both components to be introduced through a single access site without requiring large incisions for separate manipulation.
Solution Approach 2:
The delivery system combines the annular prosthesis and valve prosthesis into a single integrated delivery apparatus. This merging allows both components to be introduced through the same access site and deployed sequentially, enabling minimally invasive implantation while maintaining reliable valve anchoring.
4Ease of manufacture
If the prosthetic valve does not fit optimally within the annulus, then implantation is simpler, but natural blood hemodynamics are impaired leading to clotting and calcification
Solution Approach 1:
The traditional suture-based anchoring system is replaced with a mechanical guide rail and receptacle system. This substitution provides more precise and repeatable positioning of the valve prosthesis within the annulus, ensuring optimal fit and hemodynamics while simplifying the implantation procedure through self-aligning mechanical features.
Applied Scientific Principles
This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.
Function Achieved in This Case
The system enables efficient and secure implantation of prosthetic heart valves with improved hemodynamics, reduced risk of clotting and calcification, and compatibility with minimally invasive procedures by providing a precise fit within the annulus.
Implementation Method 1
the annular member may be resiliently compressible, expandable, and/or otherwise biased
Data Source
AI summary
Multiple component heart valves and apparatus and methods for implanting them are provided. The heart valve generally includes a first annular prosthesis and a second valve prosthesis. The first prosthesis includes an annular member compressible from a relaxed condition to a contracted condition to facilitate delivery into a biological annulus, the annular member being resiliently expandable towards the relaxed condition. The first prosthesis also includes guide rails extending therefrom. The second prosthesis includes an annular frame, valve elements, and receptacles for receiving respective guide rails therethrough when the second prosthesis is directed towards the first prosthesis. In addition, a valve holder may releasably carry the valve prosthesis that includes channels for receiving respective guide rails therethrough when the guide rails are received through the valve prosthesis. A delivery tool is also provided that includes an actuator for selectively compressing the annular member into the contracted condition.