Remodelable Prosthetic Valve Thrombus Prevention
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Solution Overview
Problem
Prosthetic valves implanted in venous systems face challenges with thrombus formation and reduced functionality due to stagnation of blood, leading to thrombogenic deposition and thickening of valve leaflets during the remodeling period, which compromises valve function.
Innovation Solution
A prosthetic valve design that maintains a remodelable material in two configurations: an initial configuration for remodeling, where it is in contact with blood flow without stagnation, and a secondary configuration that regulates fluid flow by changing shape to function as a valve, using a support frame and a releasable holding member to transition between these states.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a prosthetic valve is implanted in the venous system, then valve function is provided to regulate blood flow, but thrombus formation occurs due to blood stagnation in pockets about the valve bases
Solution Approach 1:
The patent employs a remodelable material that dynamically transforms from an initial configuration to a second configuration over time. The material is initially in a first configuration that minimizes blood stagnation and thrombus formation, then remodels to a second configuration that provides valve function. This dynamic transformation resolves the contradiction by allowing the structure to adapt its properties over time rather than being static.
Solution Approach 2:
The remodelable material is prepared in a specific initial configuration before implantation that prevents thrombus formation. This preliminary state is designed to address the thrombus formation issue during the critical early period after implantation, before the material remodels to its final valve-providing configuration.
2Object-affected harmful factors
If remodelable material is used to provide a thrombo-resistant surface, then thrombus formation is reduced, but the material requires time to remodel which delays valve functionality
Solution Approach 1:
The patent uses a remodelable material that dynamically changes from an initial configuration optimized for preventing thrombus formation to a second configuration that provides valve function. This dynamic transformation allows the system to sequentially address both requirements - first preventing thrombus, then providing valve function - without permanent compromise of either aspect.
Solution Approach 2:
The valve structure undergoes periodic transformation through remodeling phases. The material is initially configured to prevent thrombus formation, then gradually remodels over time to provide valve function. This periodic transition resolves the time loss issue by structuring the remodeling process to ultimately achieve full functionality.
3Object-affected harmful factors
If the remodelable material is positioned to contact blood flow for remodeling, then thrombogenic deposition is reduced, but the material must be held in place which complicates the device structure
Solution Approach 1:
The remodelable material is designed to self-remodel through contact with blood flow without requiring complex external control mechanisms. The material inherently transforms from its initial to second configuration through biological processes, eliminating the need for complex mechanical actuators or control systems that would increase device complexity.
Data Source
AI summary
Prosthetic medical devices with delayed valve function and in situ remodeling of a portion thereof are provided, as well as methods of manufacturing the medical devices and methods of treatment using the medical devices. The medical devices may be adapted to initially maintain a remodelable material within a body vessel in a first configuration suitable to contact the remodelable material with a body fluid contacting the remodelable material for a first time period or a second configuration adapted to regulate the flow of body fluid contacting the remodelable material. The medical devices may include a releasable holding member configured to retain the remodelable material in the first configuration.