Prosthetic Heart Valve Spring Collar for Annular Conformity
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Solution Overview
Problem
The complexity of securing prosthetic heart valves within the heart's annulus, often requiring multiple sutures and cardiopulmonary bypass, can lead to suboptimal fit and impaired blood hemodynamics, resulting in clotting and calcification due to the mismatch between the sewing ring and annulus shape.
Innovation Solution
A heart valve assembly featuring a resiliently compressible and expandable annular member with a collar and spring structure, allowing for secure attachment of a prosthetic valve above the annulus, facilitating better fit and blood flow, and enabling easy access for connector placement.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Strength
If a rigid sewing ring is used to secure the prosthetic valve, then the valve can be firmly attached, but it cannot conform to the irregular annulus shape, resulting in impaired blood hemodynamics
Solution Approach 1:
The sewing ring is divided into multiple discrete segments or struts that are connected by flexible joints. This segmentation allows each segment to independently adjust its position and orientation, enabling the overall ring structure to conform to the irregular annulus shape while maintaining secure attachment capability through the cumulative effect of multiple attachment points.
Solution Approach 2:
The sewing ring transitions from a static, rigid structure to a dynamic, adaptable structure with movable joints and flexible connections. This dynamic design allows the ring to change its configuration during implantation to match the annulus geometry, and potentially continue to adapt to physiological movements and shape changes over time.
2Adaptability or versatility
If flexible material is used for the sewing ring to conform to the annulus, then blood hemodynamics improve, but the attachment procedure becomes more complex and time-consuming
Solution Approach 1:
The sewing ring segments are pre-configured with connection mechanisms and attachment features that simplify the implantation process. The flexible segments are designed to self-align or automatically engage with corresponding structures on the annulus or valve, reducing the need for complex manual manipulation and precise positioning during surgery.
Solution Approach 2:
Connection elements such as flexible joints, linkages, or intermediate structures are introduced between the sewing ring segments and the annulus/valve interface. These intermediaries facilitate easier attachment by providing simplified connection mechanisms that reduce procedural complexity while maintaining the flexibility needed for conformability.
3Strength
If multiple sutures are used to secure the sewing ring, then firm attachment is achieved, but the procedure requires lengthy cardiopulmonary bypass and increases risk of complications
Solution Approach 1:
Multiple separate suture attachment operations are merged into a single integrated sewing ring structure that can be attached as one unit. The segmented design allows multiple attachment points to be secured simultaneously or in sequence with simplified procedures, reducing the overall time required compared to securing multiple individual sutures separately.
Solution Approach 2:
The sewing ring is designed as a single-use, disposable component that is pre-configured with all necessary attachment features. This eliminates the need for complex, time-consuming suture manipulation and knot-tying procedures, as the ring can be attached more rapidly and then discarded, reducing cardiopulmonary bypass time and associated risks.
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
This solution enhances the fit and performance of prosthetic heart valves by allowing for a more secure and anatomically conforming placement, reducing the risk of clotting and calcification, while enabling easier implantation and potential for larger valve sizes to improve fluid flow.
Implementation Method 1
a spring structure for supporting the collar away from the annular member
Implementation Method 2
The collar and/or annular member may be resiliently compressible, expandable, and/or otherwise movable relative to one another
Data Source
AI summary
A heart valve prostheses includes an annular member implantable within a biological annulus, a collar extending upwardly from the annular member, and a sewing ring extending from the annular member. A spring structure couples the collar to the annular member and biases the collar to align with the annular member at a predetermined distance above the annular member. During use, the prosthesis is introduced into a biological annulus, and fasteners are directed through the sewing ring into surrounding tissue to secure the prosthesis with the annular member within the biological annulus. A mechanical or bioprosthetic valve is introduced and coupled to the collar, e.g., using tabs or other connectors on the collar. The spring structure allows the collar to be directed towards the annular member and/or folded inwardly, e.g., to facilitate accessing the sewing ring to deliver fasteners.