Resilient Sewing Cuff for Prosthetic Heart Valve Sealing
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Solution Overview
Problem
The complexity of securing prosthetic heart valves within the heart's annulus due to mismatched shapes and the need for multiple sutures leads to impaired blood hemodynamics, clotting, and calcification, with existing flexible sewing rings not effectively mating with the valve, causing leaks and performance issues.
Innovation Solution
A heart valve assembly with a resiliently compressible or expandable annular member and a conformable sewing cuff that can adapt to the annulus shape, featuring connectors for secure orientation and a flexible skirt for enhanced sealing, allowing for better fit and reduced suture complexity.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Strength
If a rigid sewing ring is used to secure the prosthetic valve within the annulus, then the valve can be firmly anchored, but the blood hemodynamics are impaired leading to clotting, emboli production, and calcification
Solution Approach 1:
The patent employs a flexible sewing ring made of compliant material that can deform and conform to the irregular anatomy of the native annulus. This flexibility allows the ring to adapt to the non-circular cross-section of the annulus while maintaining secure anchoring, thereby preventing blood hemodynamics impairment, clotting, and calcification that would occur with rigid rings
2Object-affected harmful factors
If flexible sewing rings are used to conform to the annulus shape, then blood hemodynamics are improved, but the valve and sewing ring may not mate together effectively causing leaks and performance issues
Solution Approach 1:
The patent utilizes a dynamically adaptable sewing ring that can change its shape and configuration to simultaneously achieve conformability to the annulus for improved hemodynamics and effective mating with the valve component. The ring's flexibility allows it to deform during implantation to ensure proper engagement with the valve while maintaining the conformable shape for optimal blood flow
3Strength
If multiple sutures are used to secure the sewing ring within the annulus, then the valve can be firmly anchored, but the procedure becomes complicated and time-consuming
Solution Approach 1:
The patent integrates the anchoring function directly into the flexible sewing ring structure itself, eliminating the need for separate suture management. The ring's flexible design allows it to be self-anchoring or easily secured with minimal sutures, combining the anchoring and sealing functions into a single component that reduces procedural complexity and implantation time
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
The solution enables improved sealing and reduced risk of clotting and calcification by ensuring a better fit of the prosthetic valve within the annulus, enhancing blood flow and valve performance while simplifying the implantation process.
Implementation Method 1
the annular member may be resiliently compressible, expandable, and/or otherwise biased for dilating the biological annulus
Implementation Method 2
the sewing cuff may be conformable for at least partially adopting a shape of tissue above or within the biological annulus
Data Source
AI summary
A heart valve assembly including an annular prosthesis implantable within a biological annulus, a prosthetic valve including a multiple lobular shape for implantation above the biological annulus, and one or more connectors for securing the prosthetic valve to the annular prosthesis. A flexible sewing cuff extends radially from the annular prosthesis that is resiliently flexible for conforming to the multiple lobular shape of the prosthetic valve to enhance a seal between the prosthetic valve and the annular prosthesis. The sewing cuff may include a core resiliently conformable with anatomy surrounding the biological annulus and fabric covering at least a portion of the core.