Temporary Vascular Valve for Hemodynamic Stabilization
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Solution Overview
Problem
Current cardiac valve repair and replacement methods face challenges with temporary support for patients during transcatheter or surgical procedures, particularly in cases of acute valvular insufficiency and degeneration of transcatheter or surgical aortic valve replacements, leading to hemodynamic instability and complications.
Innovation Solution
Development of a temporary vascular valve device with an expandable frame and membrane that can be deployed and collapsed for percutaneous implantation, providing hemodynamic support until a permanent valve replacement is in place, and can be easily removed when no longer needed.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Duration of action of stationary object
If a permanent valve replacement is performed, then long-term valve durability is achieved, but the patient requires complex surgical procedures and prolonged recovery time
Solution Approach 1:
The valve replacement process is segmented into two distinct phases: temporary support phase using a percutaneous valve device, and permanent replacement phase using a surgical or transcatheter valve. This segmentation allows the complex permanent replacement to be prepared for in a controlled manner while the patient receives temporary valve support
Solution Approach 2:
The temporary valve device is implanted and activated before the permanent valve replacement procedure. This preliminary action stabilizes the patient's hemodynamics in advance, ensuring they can tolerate the subsequent complex surgical or transcatheter procedure without acute valve insufficiency
2Ease of operation
If transcatheter aortic valve replacement is performed, then less invasive procedure is achieved, but patient support is required during procedure preparation and complications can occur
Solution Approach 1:
The temporary valve device serves as a cushioning measure implanted before the TAVR procedure. It provides a safety net that can be activated if complications arise during TAVR preparation or execution, such as acute valve insufficiency or hemodynamic collapse, thereby cushioning the patient against procedural risks
3Productivity
If percutaneous balloon valvuloplasty is performed, then acute aortic insufficiency may occur, but permanent valve replacement becomes necessary
Solution Approach 1:
The temporary valve device acts as an intermediary between PABV and permanent valve replacement. After PABV creates acute aortic insufficiency, the temporary valve is deployed to bridge the hemodynamic gap, allowing the patient to stabilize before undergoing definitive TAVR or surgical replacement, thereby mediating the transition from palliative to curative treatment
4Ease of repair
If degenerated TAVR or SAVR is removed, then wide open aortic insufficiency occurs, but patient support is essential during removal
Solution Approach 1:
The temporary valve device is deployed in advance to counteract the harmful effect of valve removal. When degenerated TAVR or SAVR is removed, the temporary valve is already in place to prevent wide open aortic insufficiency and hemodynamic collapse, providing preliminary anti-action against the removal complication
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 temporary valve device stabilizes patients with acute valve insufficiency, allowing for safe transition to permanent valve replacement by maintaining valve competence and preventing hemodynamic collapse, with the ability to be deployed and retrieved with minimal force, reducing the complexity and risk of existing procedures.
Implementation Method 1
an expandable frame comprising a flexible material... the temporary valve device is movable into an expanded configuration for deployment of the device in a target vascular area
Implementation Method 2
the temporary valve device is movable into a collapsed configuration for both delivery of the device to the target vascular area and for removal of the device from the target vascular area
Data Source
AI summary
Various temporary or removable valve devices having an expandable frame comprising a flexible material and a membrane attached to the expandable frame, wherein the temporary valve device is movable into an expanded configuration for deployment of the device in a target vascular area and further is movable into a collapsed configuration for both delivery of the device to the target vascular area and for removal of the device from the target vascular area.