Cardiac Valve Prosthesis Gradual Deformation for Hemodynamic Load Management
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Solution Overview
Problem
Current treatments for cardiac valve insufficiency, such as surgical implantation of prosthetic valves, are invasive and carry significant risks, particularly for patients with advanced age or concomitant pathologies, and often result in sudden changes in hemodynamic load that can lead to acute complications due to the need for immediate correction of regurgitation and adaptation to dilated annulus dimensions.
Innovation Solution
A sutureless, radially collapsible cardiac valve prosthesis with a prosthetic member that undergoes a gradual deformation from an altered temporary configuration to a stable, predetermined configuration, allowing for a gradual elimination of valve regurgitation and inverse remodeling of the native valve annulus, reducing the sudden increase in hemodynamic load and enabling implantation in dilated annuli, using bio-erodible retention members for controlled deformation and recovery.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If conventional surgical implantation of prosthetic valves is performed, then valve replacement is achieved, but patient trauma and surgical risk increase significantly
Solution Approach 1:
The prosthetic valve is designed with a flexible, radially collapsible structure that can be compressed into a small profile for catheter-based delivery and then expanded at the implantation site. This flexible shell design enables minimally invasive transcatheter implantation while maintaining the structural integrity and functionality of the valve, thereby reducing patient trauma and surgical risk compared to conventional open-heart surgery.
Solution Approach 2:
The prosthetic valve is nested within a delivery catheter in a compressed state, allowing it to be delivered through a peripheral vascular access point. Once positioned at the implantation site, the valve is expanded from its nested state to its functional configuration. This nesting approach enables minimally invasive implantation without requiring open-heart surgery, thus reducing patient trauma and surgical risk.
2Reliability
If immediate correction of valve regurgitation is performed, then valve function is restored, but sudden hemodynamic load changes cause acute complications
Solution Approach 1:
The prosthetic valve incorporates a gradual deformation mechanism where the prosthetic member transitions from an altered temporary configuration to a stable predetermined configuration over time. This dynamic adjustment allows the valve to gradually correct regurgitation and enable the myocardial muscle to adapt to changing hemodynamic loads, preventing acute complications while restoring valve function.
Solution Approach 2:
The prosthetic valve is initially deployed in an altered temporary configuration that provides partial regurgitation, allowing the myocardial muscle to gradually adapt to the changing hemodynamic conditions. Over time, the valve progressively deforms to its stable configuration, achieving complete regurgitation correction. This preliminary action approach prevents sudden hemodynamic load changes that could cause acute complications.
3Reliability
If prosthesis is designed for stable configuration, then valve function is optimized, but inability to adapt to dilated annulus dimensions limits implantation options
Solution Approach 1:
The prosthetic valve is designed with a dynamic structure that can adapt to different annulus dimensions. The prosthetic member gradually deforms from an altered temporary configuration to a stable predetermined configuration, allowing the valve to accommodate dilated annulus dimensions initially and then optimize its function as the native annulus undergoes inverse remodeling. This dynamic adaptability expands implantation options while maintaining valve function optimization.
4Object-generated harmful factors
If gradual deformation of prosthetic member is implemented, then hemodynamic load increase is minimized, but device complexity increases
Solution Approach 1:
The prosthetic valve utilizes parameter changes in the prosthetic member's geometric configuration to achieve gradual deformation. The member transitions from an altered temporary configuration with specific geometric parameters to a stable predetermined configuration with optimized parameters. This parameter-based approach enables gradual hemodynamic load management while controlling device complexity through systematic geometric transformation.
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 allows for a gradual correction of valve insufficiency, reducing the risk of acute complications by minimizing the sudden increase in hemodynamic load and enabling the reduction of prosthesis dimensions over time, thereby improving patient outcomes and reducing the trauma to the myocardial muscle.
Implementation Method 1
The prosthetic member is preconfigured so as to move gradually during use from the altered temporary functional configuration to the stable, predetermined functional configuration. Advantageously, the change of the prosthetic member from the altered temporary functional configuration to the stable, predetermined functional configuration can be carried out by resilient return.
Implementation Method 2
Those retention members are provided for gradual dissolution after the implantation of the cardiac prosthesis so as to allow the change of the prosthetic member from the altered temporary functional configuration to the stable, predetermined functional configuration.
Data Source
AI summary
A prosthesis for a cardiac valve includes prosthetic leaflets which are intended to functionally replace the native leaflets of a cardiac valve following the implantation of the cardiac prosthesis. The prosthesis also includes a prosthetic member on which there are mounted the prosthetic leaflets and which is intended to take up a stable, predetermined functional configuration in which the prosthetic member and the prosthetic leaflets reproduce the functionally correct configuration for the purpose of the physiological replacement of the native cardiac valve. The prosthetic member is preconfigured so as to move gradually from an altered, temporary functional configuration, in which the prosthetic member has a deformed geometry with respect to the stable, predetermined stable functional configuration, to said stable, predetermined functional configuration.