Heart Valve Prosthesis Skirt Flaps Decoupling Stress
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Solution Overview
Problem
Existing heart valve prostheses face challenges such as premature failure due to wear, complexity in manufacture, and suboptimal performance, particularly in the design of leaflets and stent frames, which can lead to inadequate sealing and stress concentration.
Innovation Solution
The heart valve prosthesis features a stent frame with a decoupling element, comprising a skirt with flexible skirt flaps that provide a flexible attachment of the leaflets to the commissure cells, reducing mechanical stress and improving durability.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Strength
If the leaflets are rigidly attached to the stent frame, then the structural support is improved, but the stress concentration and wear increase leading to premature failure
Solution Approach 1:
The patent employs a flexible skirt made of a thin film material that attaches the leaflets to the stent frame in a compliant manner. This flexible attachment allows the skirt to deform and absorb mechanical stresses, preventing stress concentration at rigid attachment points while maintaining structural support. The thin film nature of the skirt enables it to conform to the stent frame geometry while providing a compliant interface between the rigid stent and the leaflets.
Solution Approach 2:
The skirt acts as an intermediary element between the stent frame and the leaflets. Rather than directly attaching the leaflets to the rigid stent frame, the skirt serves as a mediating structure that distributes loads and accommodates relative movements. This intermediary component prevents direct stress transfer from the rigid stent to the leaflet attachment points, thereby reducing wear and preventing premature failure.
2Reliability
If the stent frame is designed with complex structure to support leaflets, then the sealing performance is improved, but the manufacturing complexity increases
Solution Approach 1:
The patent replaces complex rigid sealing structures with a simple flexible skirt made of thin film material. This skirt can be easily manufactured and attached to the stent frame, yet it provides effective sealing by conforming to the anatomical structure and maintaining contact with surrounding tissues. The flexibility of the thin film allows it to adapt to variations in geometry without requiring complex rigid structures.
Solution Approach 2:
Instead of designing a complex rigid structure to achieve sealing, the patent inverts the approach by using a simple flexible structure that achieves sealing through compliance and adaptation. Rather than forcing a rigid seal, the flexible skirt naturally conforms to the surrounding anatomy, achieving sealing through its ability to deform and maintain contact.
3Reliability
If the leaflet attachment is made flexible to reduce stress, then the durability is improved, but the structural stability deteriorates
Solution Approach 1:
The flexible skirt made of thin film material provides a compliant attachment that reduces stress concentration while maintaining structural stability. The thin film's flexibility allows it to deform under load, preventing stress buildup, while its continuous structure and attachment to the rigid stent frame maintain overall structural stability. The skirt acts as a stress-distributing element that preserves structural integrity.
Solution Approach 2:
The patent creates a composite structure combining the rigid stent frame with the flexible thin film skirt. This composite design leverages the strengths of both materials: the rigid stent provides structural stability and support, while the flexible thin film skirt provides compliant attachment that reduces stress and improves durability. The combination of rigid and flexible components achieves both structural stability and reduced stress concentration.
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 design enhances the flexibility and durability of the heart valve prosthesis, reducing stress on the leaflets and prolonging the device's lifespan by allowing for better stress distribution and optimal functioning.
Implementation Method 1
a skirt attached to the stent frame, wherein the skirt comprises a skirt main body and at least two, preferably three, skirt flaps being integral with or being attached to the skirt main body
Data Source
AI summary
The present invention concerns a heart valve prosthesis for implantation into the heart of a patient, wherein the heart valve prosthesis comprises a stent frame and a plurality of cells arranged in circumferential rows, a valve element being mounted to the prosthetic heart valve and comprising at least two, preferably three, leaflets, a skirt attached to the stent frame, wherein the skirt comprises a skirt main body and at least two, preferably three, skirt flaps being integral with or attached to the skirt main body, wherein the skirt main body covers at least the proximalmost row of cells of the stent frame, wherein each of the skirt flaps, in a folded state, forms a decoupling element, and wherein each of the skirt flaps covers one commissure cell of the distalmost row of cells of the stent frame, and wherein the leaflets, via a decoupling element, are, respectively, mounted to the prosthetic heart valve within the commissure cells of the distalmost row of cells.