Prosthetic Heart Valve Tether Securement Coupling
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Solution Overview
Problem
Current methods for delivering and deploying prosthetic heart valves, particularly for mitral valve replacements, face challenges in securing anchoring tethers and maintaining the valve's position within the heart, leading to higher morbidity and costs due to the need for open-heart surgery and extra-corporeal circulation.
Innovation Solution
A prosthetic heart valve design featuring a tether securement portion with a coupling mechanism that uses shape-memory materials and braided filaments, secured with sutures, and a positioning device for precise placement, allowing for transcatheter delivery and anchoring within the heart.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If traditional open-heart surgery is used for valve replacement, then the valve can be securely implanted, but the patient experiences high morbidity and requires extra-corporeal circulation
Solution Approach 1:
The patent replaces the mechanical open-heart surgical system with a transcatheter delivery system that uses minimally invasive percutaneous access. The prosthetic valve is delivered through a catheter and deployed within the heart without requiring thoracic opening or heart-lung machine support, thereby eliminating the harmful effects of extra-corporeal circulation while maintaining secure valve implantation through specialized anchoring mechanisms
Solution Approach 2:
The patent changes the procedural parameters from open surgical access to percutaneous catheter-based access. By transforming the delivery approach from surgical incision to transluminal catheter insertion, the procedure achieves equivalent valve replacement outcomes with significantly reduced patient morbidity and elimination of extra-corporeal circulation requirements
2Reliability
If anchoring tethers are used to secure the prosthetic valve, then the valve position is maintained, but the tether attachment to the valve presents technical challenges
Solution Approach 1:
The patent divides the tether securement function into separate modular components: the tether itself, the securement portion with coupling features, and the frame structure. This segmentation allows each component to be optimized independently and simplifies the attachment process by providing dedicated coupling interfaces between the tether and valve frame, reducing overall system complexity
Solution Approach 2:
The patent introduces a tether securement portion as an intermediary component between the anchoring tether and the prosthetic valve frame. This intermediate structure provides specialized coupling features that facilitate reliable tether attachment while simplifying the integration with the valve assembly, thereby reducing the technical challenges of direct tether-to-valve attachment
3Ease of operation
If a tether securement portion with coupling features is added to the prosthetic valve, then tether attachment is improved, but the device complexity increases
Solution Approach 1:
The patent merges the tether securement portion with the prosthetic valve frame structure, integrating the coupling features directly into the valve assembly. This combination eliminates the need for separate attachment hardware and simplifies the overall device by consolidating multiple functions into unified structural elements, thereby improving ease of operation without proportionally increasing complexity
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 secure anchoring and positioning of prosthetic heart valves, reducing the need for open-heart surgery and extra-corporeal circulation, thereby lowering morbidity and costs, while facilitating more efficient and minimally invasive mitral valve replacement procedures.
Implementation Method 1
The tether securement portion can include a shape-memory material and the coupling feature can be formed with the shape-memory material
Data Source
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AI summary
Apparatus and methods are described herein for various embodiments of a prosthetic heart valve that have a tether securement feature that can be used to secure an anchoring tether to the prosthetic heart valve such that the tether can maintain the prosthetic heart valve in a desired position within the heart under high tensile forces applied to the tether during functioning of the heart. In some embodiments the tether securement feature can also include an engagement member that can be used to help position the prosthetic heart valve within a heart. Such an engagement member can be matingly engaged by a positioning device that can be used to help in radial positioning of the prosthetic heart valve during delivery and deployment of the prosthetic heart valve.