Dynamic Valve Support for Irregular Annular Sealing
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Solution Overview
Problem
Current approaches for replacing complex anatomical structures like the mitral and tricuspid heart valves face challenges due to their irregular shapes and high inter-patient variability, leading to difficulties in achieving optimal sealing and tissue anchoring with universal, pre-shaped prostheses.
Innovation Solution
A flexible, dynamic supporting structure made of elastic material that can be shaped in real-time to conform to individual anatomies, incorporating shapeable and reinforcing elements for optimal sealing and anchoring, which can be deployed via minimally invasive trans-catheter procedures and filled with biocompatible materials for stability and movement compatibility with the cardiac cycle.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of manufacture
If universal pre-shaped prostheses are used for valve replacement, then device complexity is reduced and ease of manufacture is improved, but sealing effectiveness and tissue anchoring are worsened due to anatomical variability
Solution Approach 1:
The supporting structure employs a dynamic design where the frame can be deformed and shaped in real-time during the procedure to match the patient's specific annular anatomy. This dynamic adaptability allows a single universal device to achieve patient-specific fitting without requiring multiple pre-shaped options, thus maintaining ease of manufacture while improving sealing effectiveness.
Solution Approach 2:
The device utilizes parameter changes by modifying the geometric configuration of the supporting structure during implantation. The frame's shape, size, and orientation can be adjusted to conform to the irregular annular anatomy, transforming a universal device into a customized solution that ensures optimal sealing and tissue anchoring.
2Reliability
If patient-specific custom-shaped prostheses are manufactured, then sealing effectiveness and tissue anchoring are improved, but device complexity and manufacturing difficulty increase
Solution Approach 1:
The supporting structure is segmented into a modular frame design that can be independently deformed and shaped. This segmentation allows the device to achieve complex patient-specific configurations through simple geometric transformations of individual frame segments, rather than requiring a completely custom-designed prosthesis for each patient.
Solution Approach 2:
The device achieves universality by designing a single supporting structure that can adapt to various annular anatomies through geometric deformation. This multi-functional design eliminates the need for multiple patient-specific device variants, reducing manufacturing complexity while maintaining the ability to achieve optimal sealing for different anatomical configurations.
3Stability of the object's composition
If rigid pre-shaped structures are used, then structural stability is improved, but adaptability to irregular anatomies is worsened
Solution Approach 1:
The supporting structure transitions from a rigid pre-shaped state to a dynamically adaptable configuration during implantation. The frame can be deformed to match the patient's anatomy and then stabilized in the desired position, combining the benefits of both rigidity for stability and flexibility for adaptability.
Solution Approach 2:
The device incorporates flexible components in the supporting structure that allow geometric deformation to conform to irregular annular anatomies. These flexible elements maintain structural integrity while enabling the device to adapt to various patient-specific configurations, bridging the gap between rigidity and flexibility.
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 enables precise, patient-specific fitting and sealing of prosthetic valves, minimizing tissue and anatomical structure damage, while ensuring effective sealing and anchoring across various anatomical configurations, reducing paravalvular leaks and maintaining functionality with the cardiac cycle.
Implementation Method 1
The flexible carrying element may be made of an elastic material up to the extent enabling predominantly radial expansion upon filling of the plurality of shapeable elements
Data Source
AI summary
The present disclosure relates to a supporting structure for accommodating a prosthetic valve aimed at replacing valve, a prosthetic valve system, a method for sealing between a native tissue and a prosthetic implant, a kit for implanting a prosthetic valve and a medium to be used with a supporting structure. The technique provides an implant structure with high compatibility with various anatomies while allowing optimal sealing and tissue anchoring, thus implementing personalized valve replacement procedures. This technique provides an accurate fitting for optimal sealing and anchoring to various complex anatomies necessitating a prosthesis.