In-Situ Forming Valve Using Shape Memory Alloy
Find Innovative SolutionsGenerate Solutions
Solution Overview
Problem
Existing prosthetic valve designs face issues such as leaflet deterioration, calcification, paravalvular leaks, and size limitations, which restrict their use in smaller catheters and exclude children as beneficiaries, necessitating a more compact and durable in-situ forming valve solution.
Innovation Solution
An in-situ forming valve system comprising an expandable component and a sheet component that transforms into a functional valve upon expansion, allowing for self-deployment within the body without surgical intervention, using materials like shape memory alloys and bioactive agents, and featuring a collapsible design for minimally invasive delivery.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If traditional prosthetic valve designs are used, then valve function is achieved, but leaflet deterioration and calcification occur over time
Solution Approach 1:
The patent inverts the traditional valve structure by forming leaflets in-situ from the native valve annulus tissue itself rather than using pre-formed artificial leaflets. This inversion uses the patient's own tissue to create functional leaflets, eliminating the deterioration and calcification issues associated with traditional artificial valve materials.
Solution Approach 2:
The native valve annulus tissue serves itself by being transformed into functional leaflets through the deployment mechanism. The tissue automatically forms the valve structure without requiring external artificial leaflet components, thereby self-resolving the durability and biocompatibility issues of traditional prosthetic valves.
2Reliability
If larger prosthetic valves are used to ensure proper function, then valve performance is improved, but delivery through small catheters becomes impossible
Solution Approach 1:
The valve deployment system employs a nested structure where the collapsible frame and native tissue are contained within a delivery catheter. The frame can be compressed to a small profile for delivery through minimal access catheters, then expanded in-situ to provide full valve functionality, effectively nesting the large functional valve within a small delivery device.
Solution Approach 2:
The valve system transitions from a static pre-formed structure to a dynamic in-situ formation process. The collapsible frame dynamically changes from a compressed delivery state to an expanded functional state, allowing the valve to achieve full size and performance only after deployment within the body, thereby decoupling delivery size from functional size.
3Productivity
If pre-formed prosthetic valves are implanted, then immediate valve function is achieved, but paravalvular leaks occur
Solution Approach 1:
The patent changes the fundamental parameter of valve formation from pre-formed artificial structure to in-situ tissue transformation. By using the patient's own annulus tissue to form leaflets that naturally conform to the native anatomy, the valve achieves optimal sealing against the native structures, eliminating paravalvular leaks while maintaining immediate functionality.
4Ease of operation
If minimally invasive delivery is used, then patient trauma is reduced, but precise positioning and formation of the valve becomes difficult
Solution Approach 1:
The native valve annulus tissue serves as both the target structure and the material for valve formation. The tissue automatically guides the formation process and provides natural anchoring points, eliminating the need for complex external positioning mechanisms and suturing procedures that would increase patient trauma.
Solution Approach 2:
The patent merges the delivery catheter, deployment mechanism, and valve formation process into a single integrated system. The collapsible frame and tissue transformation occur simultaneously within the body through the minimally invasive catheter, combining multiple functions into one procedure that maintains both patient comfort and positioning precision.
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 provides a compact, durable, and self-deployable valve system that can be delivered through small catheters, reducing the risk of leaflet impingement and calcification, while ensuring proper apposition and minimizing paravalvular leaks, thus expanding the technology's applicability to all age groups.
Implementation Method 1
using materials like shape memory alloys and bioactive agents
Data Source
AI summary
The present invention satisfies the long felt need for a more compact and durable valve which may be formed in situ. The present invention provides a self-deployable valve system, a method of delivery, and a method of manufacturing for the self-deployable valve system. The present invention delivers the necessary components for forming a complete valve system in situ. The collapsed subcomponents of the system lack any functional characteristics commonly associated with a valve before being expanded. However, once expanded, the system is transformed into a competent valve for use in a wide variety of applications.