Two-part mitral valve prosthesis with rotatable locking
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Solution Overview
Problem
The challenge in prosthetic heart valve implantation is the risk of suture looping due to entanglement between commissure posts and sutures, which complicates the procedure and can disrupt valve operation, especially in minimally-invasive approaches where visibility is limited.
Innovation Solution
A multi-component heart valve prosthesis system comprising a separable tissue valve element and a sewing ring element, where the valve element can be rotated relative to the sewing ring after suture attachment, allowing for fine-tuning of commissural post locations and preventing axial movement once engaged, thereby reducing the risk of suture looping.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a traditional single-piece valve prosthesis is used, then the implantation procedure is simpler in terms of components, but the risk of suture looping increases due to entanglement between commissure posts and sutures
Solution Approach 1:
The valve prosthesis is divided into two separate components: a valve body and a sewing ring. The sewing ring is sutured to the annulus first, then the valve body is inserted through the sewing ring. This segmentation separates the suturing function from the valve function, eliminating the risk of suture looping because the valve body is inserted after the sewing ring is secured, and the commissure posts are not in contact with the sutures.
2Object-affected harmful factors
If minimally-invasive access approach is used, then patient trauma is reduced, but visibility of the surgical field is limited making it difficult to detect suture looping
Solution Approach 1:
The valve body is extracted from the sewing ring assembly, allowing the surgeon to first complete the suturing of the sewing ring to the annulus with full visibility, then separately insert the valve body through the sewing ring. This extraction separates the visible suturing process from the valve insertion, enabling the surgeon to detect and address any suture looping issues before the valve is implanted, while still maintaining the benefits of minimally-invasive access.
3Productivity
If the valve is inserted as a single unit with the sewing ring, then implantation time is reduced, but the ability to fine-tune commissural post locations is lost
Solution Approach 1:
The valve body is designed to be dynamically adjustable relative to the sewing ring. After the valve body is inserted through the sewing ring, the surgeon can rotate the valve body to different angular positions to optimize the alignment of commissure posts with the annular geometry. This dynamic adjustability allows for fine-tuning of commissural post locations while maintaining a relatively simple two-component structure that does not significantly extend implantation time.
Data Source
AI summary
In certain embodiments, a multiple component heart valve prosthesis includes an abutment ring and a removable bioprosthetic heart valve. The abutment ring is configured for attachment at a heart valve annulus location and includes a locking system. The removable bioprosthetic heart valve includes a valve frame and at least one locking feature. The at least one locking feature is configured to be received by the locking system. The bioprosthetic heart valve can be rotated relative to the abutment ring such that the at least one locking feature transitions from a disengaged position to a first engaged position. When in the disengaged position the bioprosthetic heart valve may be removed from the abutment ring, and when rotated to the engaged position the bioprosthetic heart valve is restrained from axial movement relative to the abutment ring.