Vascular Device Struts for Valve Leaflet Apposition
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Solution Overview
Problem
Current treatments for venous valve insufficiency, such as external stockings and invasive surgeries, are uncomfortable, costly, and carry risks, while existing minimally invasive devices are complex and difficult to insert due to their size.
Innovation Solution
An intravascular device with a longitudinal axis and radially diverging struts that expand to engage the vessel wall, bringing it inwardly to approximate valve leaflets, potentially made of shape memory material and featuring vessel engaging members with penetrating tips, allowing for minimally invasive insertion and operation.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If external stockings are used to apply pressure to the vein, then valve leaflet apposition is achieved, but patient comfort and appearance are compromised
Solution Approach 1:
The invention extracts the pressure application function from external stockings and transfers it to an intravascular device. The device is implanted directly within the vein to apply radial inward pressure on the vessel wall, eliminating the need for external stockings and their associated discomfort and appearance issues.
Solution Approach 2:
The intravascular device acts as an intermediary between the need for vein compression and the patient's comfort. By placing the compression mechanism inside the vein rather than outside the body, the device mediates the conflict between effective treatment and patient comfort.
2Reliability
If invasive surgery with internal cuff implantation is performed, then valve leaflet apposition is achieved, but surgical risks and recovery time increase
Solution Approach 1:
The device employs a dynamic delivery system where the struts transition from a compressed delivery configuration to an expanded functional configuration. This dynamic transformation allows the device to be delivered through a minimally invasive catheter and then deployed to the final position, avoiding the need for large incisions and complex open surgery.
Solution Approach 2:
The device utilizes a nested structure where the struts are contained within a delivery catheter in a compressed state. Upon deployment, the struts expand outward from the catheter to their functional configuration. This nesting allows the final device to be delivered through a small catheter opening, minimizing surgical invasion.
3Ease of operation
If device size is reduced for minimally invasive insertion, then insertion difficulty decreases, but device functionality may be compromised
Solution Approach 1:
The device transitions from a small compressed configuration during delivery to a large expanded configuration during function. The struts are compressed within the catheter for easy insertion, then expand to provide sufficient radial pressure for valve leaflet apposition. This dynamic size change resolves the contradiction between small insertion profile and large functional size.
Solution Approach 2:
The device is segmented into multiple struts that can be independently compressed and expanded. This segmentation allows the overall device to be compacted to a small size for delivery while maintaining the structural integrity and functional capability of individual struts when expanded.
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
Effectively brings valve leaflets into apposition without the need for external stockings or internal cuffs, reducing discomfort and surgical risks, while minimizing the device's dimensions for easier insertion and reducing complexity.
Implementation Method 1
the struts diverging radially outwardly in the converged position... release of retention of the distal portions of the struts causes the distal portions of the struts to move outwardly away from the longitudinal axis and the proximal portions of the struts to move inwardly toward the longitudinal axis
Implementation Method 2
A plurality of vessel engaging members extend from the proximal portion of the struts for engaging the internal wall of the vessel
Data Source
AI summary
A vascular device having a plurality of struts having a distal portion and a proximal portion. The distal portion of the struts are retained in a converged position. The struts diverge radially outwardly. A plurality of vessel penetrating members extend from the proximal portion of the struts for engaging the internal wall of the vessel, wherein release of the retention of the distal portions of the struts causes the distal portions to move outwardly away from the longitudinal axis and the proximal portions of the struts to move inwardly toward the longitudinal axis such that the vessel engaging members pull the internal wall of the vessel radially inwardly.