Saddle-Shaped Prosthetic Valve with Shape Memory Anchoring
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Solution Overview
Problem
Existing prosthetic valve designs face challenges such as large delivery profiles, reduced valve orifice, sub-optimal hemodynamic characteristics, and perivalvular leakage, making them clinically ineffective for minimally invasive techniques and native valve replacement.
Innovation Solution
A prosthetic valve with a saddle-shaped annulus and paired leaflets, supported by shape memory materials like nickel titanium alloys, which transform shape to open or close in response to pressure changes, ensuring unidirectional flow and secure attachment.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Length of moving object
If traditional prosthetic valve designs are used, then structural support is provided, but delivery profile is large and minimally invasive deployment is not achieved
Solution Approach 1:
The prosthetic valve is nested within a delivery catheter in a compressed state, allowing it to pass through small access vessels. The valve is self-expanding from this nested configuration to its functional shape after deployment, achieving minimally invasive delivery while maintaining structural integrity.
Solution Approach 2:
The valve structure transitions from a static compressed state during delivery to a dynamic self-expanding state after deployment. The memory alloy material enables the valve to automatically transform from a low-profile delivery configuration to a fully expanded functional configuration in response to environmental conditions.
2Reliability
If conventional valve anchoring methods are used, then attachment is achieved, but valve orifice is reduced and hemodynamic characteristics deteriorate
Solution Approach 1:
The anchoring function is segmented from the valve orifice area. Anchoring elements are positioned at the commissures (junctions between leaflets) rather than across the central flow area, securing the valve to the annulus while preserving the central orifice for optimal blood flow.
Solution Approach 2:
Anchoring is achieved in the radial dimension through commissural engagement with the annulus, while the axial dimension remains open for unobstructed blood flow. This dimensional separation allows secure attachment without compromising the valve orifice area.
3Stability of the object's composition
If rigid valve structures are used, then structural stability is provided, but flexibility for pressure-responsive operation is reduced
Solution Approach 1:
The material parameters of the valve structure are changed by using memory alloy materials that exhibit superelasticity and shape memory effects. These materials provide structural stability at rest while automatically changing their mechanical properties in response to pressure changes, enabling flexible opening and closing operations.
Solution Approach 2:
The valve utilizes composite construction combining memory alloy materials with tissue layers. The memory alloy provides structural stability and shape retention, while the tissue layers provide flexibility and pressure-responsive behavior, achieving both structural integrity and adaptive functionality.
4Reliability
If complex anchoring mechanisms are used, then secure attachment is achieved, but device complexity increases and manufacturing becomes difficult
Solution Approach 1:
The valve employs self-expanding and self-anchoring mechanisms that automatically engage with the annulus upon deployment. The memory alloy material inherently provides the anchoring force through its elastic recovery, eliminating the need for complex external anchoring mechanisms or additional anchoring components.
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 prosthetic valve effectively replaces dysfunctional heart valves with improved hemodynamic performance, reduced leakage, and minimally invasive deployment, enhancing clinical efficacy and patient outcomes.
Implementation Method 1
supported by shape memory materials like nickel titanium alloys, which transform shape to open or close in response to pressure changes
Data Source
AI summary
In accordance with one embodiment of the present disclosure, a prosthetic valve is provided. The prosthetic valve includes an annulus, a pair of leaflets, and a pair of support elements. The annulus has a generally saddle-shape formed by a movable pair of first portions separated from each other by a movable pair of second portions. The pair of leaflets extend from the annulus and are separated from each other by the pair of support elements. The first portions of the annulus and the second portions of the annulus are configured to move back and forth from being generally concave to being generally convex such that any movement of the first portions of the annulus occurs at generally the same time as any movement of the second portions of the annulus.