Cinching Annuloplasty Rings for Post-Implant Mitral Sizing
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Solution Overview
Problem
Current mitral valve repair procedures face challenges in accurately sizing annuloplasty rings, leading to potential poor outcomes such as residual mitral regurgitation, insufficient coaptation, and high pressure gradients due to imprecise sizing, necessitating reoperation on cardiopulmonary bypass to adjust the device.
Innovation Solution
Development of adjustable annuloplasty rings with a cinching element that can be remotely controlled post-implantation to adjust the AP or AL-PM diameter of the mitral valve, allowing for precise tuning under echocardiographic guidance, minimizing regurgitation, and enabling adjustments while the heart beats.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If a fixed-size annuloplasty ring is implanted based on preoperative sizing, then the surgical procedure is straightforward, but the sizing precision is insufficient leading to poor repair outcomes
Solution Approach 1:
The annuloplasty ring is designed with dynamic adjustability, transitioning from a fixed static structure to one that can be modified post-implantation. The ring includes adjustment mechanisms such as cinching elements, tensioning members, or modular components that allow the surgeon to modify the ring's perimeter and geometry after it has been implanted, enabling precise sizing adjustments based on actual intraoperative observations of leaflet coaptation and annular dimensions.
Solution Approach 2:
The ring is initially implanted in a preliminary configuration that can be subsequently adjusted. The design incorporates pre-positioned adjustment features, attachment points, and accessible adjustment mechanisms that allow for post-implantation modification without requiring removal or replacement of the entire device, thus improving sizing precision while maintaining procedural simplicity.
2Shape
If the annuloplasty ring size is reduced to improve leaflet coaptation, then coaptation length increases, but the risk of residual mitral regurgitation or high pressure gradients increases
Solution Approach 1:
The adjustable ring design enables real-time feedback-based optimization of ring size. After initial implantation, the surgeon can directly observe leaflet coaptation, annular dimensions, and valve function (including pressure gradients and regurgitation status) and adjust the ring size accordingly. This iterative adjustment process allows optimization of coaptation length while monitoring for adverse effects such as excessive reduction causing high gradients or residual regurgitation, thereby improving repair outcome reliability.
3Productivity
If the surgeon makes an educated guess on ring size, then the procedure is completed efficiently, but the outcome may require reoperation on cardiopulmonary bypass
Solution Approach 1:
The dynamic adjustability of the ring allows the surgeon to complete the procedure efficiently with an initial estimated size and then optimize the fit intraoperatively without requiring reoperation. The adjustment mechanisms are designed to be accessible and operable during the same surgical session, enabling fine-tuning of the ring size to achieve optimal leaflet coaptation and valve function, thereby eliminating the need for repeat procedures on cardiopulmonary bypass.
4Adaptability or versatility
If an adjustable mechanism is added to the annuloplasty ring, then post-implant size adjustment is enabled, but the device complexity and manufacturing difficulty increase
Solution Approach 1:
The adjustable ring is designed as a segmented or modular structure, dividing the ring into discrete components that can be manufactured separately using standard manufacturing processes. The segmentation allows each component to be produced with conventional techniques, and the modular nature simplifies assembly and adjustment mechanisms, reducing overall manufacturing complexity while enabling post-implant size adjustment.
Solution Approach 2:
The adjustment mechanisms are designed with universal features that can be integrated into standard annuloplasty ring manufacturing processes. The design incorporates multi-functional components that serve both structural and adjustment functions, reducing the need for specialized manufacturing steps and enabling production using existing surgical device manufacturing capabilities.
Data Source
AI summary
Annuloplasty rings that are size-adjustable after implant and which facilitate deployment and reduce long-term complications. The rings each have a hollow circumference with a cinching element extending therethrough whose length is controlled remotely via a deployment system handle. The ring may be anchored to the annulus and then the size adjusted while the heart beats and under visualization to minimize regurgitation. The cinching element may be a loop of metal which is clamped to size within a junction housing to which the deployment system attaches. The rings are especially beneficial for repairing the mitral annulus, and may be saddle shaped with the junction housing located on an anterior side.