Heart Valve Prosthetic Ring Assembly with Flanged Suture Fastener
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Solution Overview
Problem
Current heart valve repair methods lack accuracy in sizing and assessing the fit and function of prosthetic reinforcement rings, leading to potential suboptimal outcomes and complications such as systolic anterior motion or suboptimal hemodynamics.
Innovation Solution
A prosthetic heart valve ring system comprising a paired ring assembly with an outer ring and an inner ring that snap-fit together, allowing for accurate sizing and physiologic assessment of valve function, with features to capture sutures and prevent damage, enabling secure and permanent placement.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If current annulus-sizers or valve-sizers are used for heart valve repair, then the procedure can be performed with simple tools, but the sizing accuracy and ability to assess optimal size are insufficient
Solution Approach 1:
The prosthetic heart valve system is divided into multiple sizeable rings that can be sequentially assembled and tested. Each ring represents a different size option, allowing the surgeon to try different configurations before final implantation, thereby achieving precise sizing without requiring complex measurement tools.
Solution Approach 2:
The system allows preliminary assembly and testing of different ring sizes before final implantation. Surgeons can assemble candidate rings, test the fit and function, and evaluate valve performance in advance, ensuring optimal sizing is selected before committing to the final implant.
2Ease of operation
If a single rigid ring prosthesis is implanted immediately, then the procedure is simple and quick, but the ability to assess fit and function before permanent placement is lost
Solution Approach 1:
The system transitions from a static, single-size prosthesis to a dynamic, multi-size assembly system. Rings can be assembled, disassembled, and reconfigured during surgery, allowing real-time assessment and adjustment. This dynamic approach maintains surgical simplicity while enabling reliable fit assessment through temporary assembly and testing.
3Strength
If sutures are captured between rigid ring surfaces, then secure attachment is achieved, but damage to sutures may occur
Solution Approach 1:
The ring surfaces feature localized cushioning elements at specific suture contact points rather than being uniformly soft. This allows the rings to maintain overall structural strength and rigidity while providing localized protection to sutures where they contact the ring surfaces, preventing damage without compromising attachment strength.
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
Enables precise sizing and functional assessment of heart valve repairs, reducing the risk of suboptimal outcomes by allowing for testing of different ring sizes and shapes before final implantation, thereby improving the accuracy and effectiveness of valve repair procedures.
Implementation Method 1
an inner ring that is sized to snap fit into the outer ring
Implementation Method 2
The reciprocal surfaces preferably include outwardly deflected portions to direct sutures outward and away from the heart valve
Data Source
AI summary
A heart valve prosthetic ring assembly includes an outer ring, and an inner ring configured and arranged to couple to the outer ring. The outer ring and inner ring having a pair of complementary mating surfaces configured and arranged to grip sutures therebetween when coupled together. Once coupled around sutures, the assembled ring set may be tightened down against the heart valve annulus to test the fit. If there are fit issues, the surgeon can remove the current ring set and replace it with another ring set of a different size/shape to determine a better fit. Once a proper size is determined, the surgeon may utilize the selected paired ring set as the final prosthetic reinforcing ring. The paired ring set may be secured in place with a flanged suture fastener which secure the ring sutures in place relative to the annulus and the ring set.