Transluminal Prosthetic Valve Support with Anchoring Elements
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Solution Overview
Problem
Ischemic heart disease causes regurgitation of heart valves due to papillary muscle dysfunction and ventricular dilation, leading to incomplete valve closure and decreased cardiac output, as the valve annulus dilation prevents proper coaptation of leaflets, resulting in blood regurgitation from the ventricle into the atrium.
Innovation Solution
A prosthetic valve support system is designed for transluminal implantation at a native heart valve, featuring a prosthetic valve that can be expanded within the support's opening and coupled using radially-expansive force, with tissue-engaging elements like anchors or clips to secure the valve, allowing for adjustable anchoring and multiple valve configurations, enabling the replacement of native valve functionality with a prosthetic solution.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a prosthetic valve is implanted to replace native valve functionality, then regurgitation is prevented and cardiac output is enhanced, but the complexity of the implantation procedure increases due to the need for specialized delivery systems and anchoring mechanisms
Solution Approach 1:
The prosthetic valve is nested within a delivery catheter system, allowing percutaneous access and minimally invasive implantation. The valve is delivered in a compressed state through the catheter and then expanded at the target site, eliminating the need for open surgical procedures while maintaining reliable valve function.
Solution Approach 2:
The delivery system performs preliminary actions by positioning and anchoring the prosthetic valve support structure before the valve itself is deployed. The support structure with anchoring elements is first secured to the native valve annulus, creating a stable foundation that simplifies subsequent valve implantation and ensures reliable positioning.
2Stability of the object's composition
If tissue-engaging elements like anchors or clips are used to secure the prosthetic valve, then the valve is firmly anchored and prevents migration, but the risk of tissue damage or complications increases
Solution Approach 1:
The anchoring elements are designed with differentiated local properties - the outer surface features engagement structures that securely anchor to the native valve annulus, while the inner surface is smooth and compliant to minimize contact with and damage to the prosthetic valve components. This local quality differentiation ensures stable positioning while reducing tissue damage risk.
Solution Approach 2:
The anchoring elements incorporate flexible and adjustable characteristics, allowing them to adapt to the native valve annulus geometry and accommodate physiological movements. The elements can dynamically adjust their engagement force and positioning, maintaining stable valve anchoring while reducing stress concentration and potential tissue damage.
3Adaptability or versatility
If the prosthetic valve support is designed to accommodate multiple valve configurations, then versatility and adaptability are improved, but the device complexity and manufacturing difficulty increase
Solution Approach 1:
The prosthetic valve support structure is designed as a universal platform that can accommodate different valve types, sizes, and configurations. The support structure includes standardized features such as adjustable anchoring elements, modular components, and configurable opening geometries that allow a single device to serve multiple functions and adapt to various clinical scenarios, thereby improving versatility without proportionally increasing manufacturing 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 facilitates the effective replacement of native valve functionality with a prosthetic valve, maintaining native leaflet function while preventing regurgitation, thus enhancing cardiac output and reducing ventricular overload.
Implementation Method 1
coupling of the prosthetic valve to the prosthetic valve support is facilitated by radially-expansive force applied by the prosthetic valve against the prosthetic valve support
Implementation Method 2
the prosthetic valve support and/or the prosthetic valve comprise tissue-engaging elements (e.g., support-anchoring elements, and valve-anchoring elements, respectively), such as anchors or clips
Data Source
AI summary
A system includes a core and a catheter for use with (A) a first atrial arm and a first ventricular arm articulatable with respect to each other at a first articulation site to clamp one leaflet of a patient's native heart valve, and (B) a second atrial arm and a second ventricular arm articulatable with respect to each other at a second articulation site to clamp another native leaflet of the native valve. The core tapers in a distal direction toward its smallest perimeter, defining a minimum nonzero angle of the atrial arms with respect to a central longitudinal axis of the core. The catheter advances the core and the arms toward the native valve. The catheter and the core have an advancement configuration in which the smallest perimeter of the core is adjacent to the first and second articulation sites. Other embodiments are also described.