Implantable Heart-Valve Adapter for Secure Anchoring and Retrieval
Find Innovative SolutionsGenerate Solutions
Solution Overview
Problem
Existing heart-valve replacement technologies face issues such as degradation of leaflets, frame breakage, migration of replacement valves, inflexibility causing trauma to heart surfaces, and challenges in secure and controlled implantation and removal.
Innovation Solution
A highly flexible and resilient heart-valve adapter with anchoring, sealing, and control features, allowing secure implantation and retrieval via a catheter, ensuring proper blood flow and conforming to heart movements.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a replacement heart valve is implanted to replace a diseased valve, then the valve function is improved, but the replacement valve may migrate or move from its desired location
Solution Approach 1:
The adapter serves as an intermediary device between the replacement valve and the native heart valve annulus. It provides a stable anchoring structure that prevents valve migration while allowing the valve to be securely positioned. The adapter acts as a mediator that transfers forces and maintains proper valve orientation and position throughout the cardiac cycle.
Solution Approach 2:
The adapter is deployed and anchored to the native valve annulus before the replacement valve is positioned. This preliminary anchoring action creates a stable foundation that prevents subsequent migration of the replacement valve. The adapter is secured in place first, then the valve is mounted onto the adapter, ensuring proper positioning from the outset.
2Strength
If a rigid frame is used for the replacement valve, then structural strength is improved, but the valve does not flex with heart movements causing trauma
Solution Approach 1:
The adapter incorporates flexible elements that allow it to conform to the dynamic movements of the heart valve annulus. The flexible structure enables the adapter to expand and contract with cardiac cycles, preventing trauma to the heart surfaces while maintaining sufficient structural strength to support the replacement valve.
Solution Approach 2:
The adapter's mechanical properties are designed to change dynamically with cardiac cycles. The frame structure transitions between rigid and flexible states based on the operational requirements - rigid during systole to maintain valve position, and flexible during diastole to accommodate annular movement, thereby preventing trauma.
3Ease of repair
If the replacement valve is made retrievable, then ease of repair is improved, but the surrounding heart tissue may be damaged during removal
Solution Approach 1:
The valve replacement system is divided into separable components: the adapter and the replacement valve. This segmentation allows the valve to be removed from the adapter through a controlled mechanism that minimizes tissue damage. The modular design enables selective removal of the valve while leaving the adapter anchored in place, reducing harm to surrounding heart tissue.
Solution Approach 2:
The adapter serves as a retrievable intermediary that can be removed with the valve if necessary. The adapter's design includes retrieval mechanisms that allow it to be pulled back through the catheter while minimizing traction on the surrounding tissue. This intermediary structure protects the heart tissue during removal by providing a controlled interface between the valve and the annulus.
4Manufacturing precision
If a laser-cut nitinol frame is used, then manufacturing precision is improved, but the frame is relatively stiff and inflexible
Solution Approach 1:
The adapter uses composite construction combining laser-cut nitinol frame with flexible polymer or fabric coatings. This composite structure maintains the manufacturing precision and structural integrity of the laser-cut nitinol while adding flexibility and conformability to match the dynamic movements of the heart valve annulus, resolving the contradiction between precision and adaptability.
Solution Approach 2:
A flexible shell or thin film coating is applied to the rigid nitinol frame. This flexible layer allows the frame to flex and conform with heart movements while the underlying nitinol structure maintains its structural strength and manufacturing precision. The flexible coating acts as a buffer between the rigid frame and the soft tissue environment.
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 adapter provides secure anchoring, sealing, and controlled expansion/retraction, reducing trauma and ensuring proper blood flow, while being retrievable and adaptable to heart movements.
Implementation Method 1
the replacement valve may move or migrate after it is placed in a desired location in the heart... Such inflexible valves do not conform to such dynamic movements
Implementation Method 2
particularly with laser-cut nitinol frames... enabling compact and secure delivery into the heart and convenient control of both the adapter during implantation as well as the expansion and retraction
Data Source
AI summary
Devices, systems, and methods for an implantable heart-valve adapter that enables compact and secure delivery into the heart and allows for convenient control of both the adapter during implantation as well as the expansion and retraction of the valve when implanted, removed, or replaced.