Temporary Percutaneous Valve With Integrated Embolic Filter
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Solution Overview
Problem
Percutaneous valve repair and replacement procedures face challenges in maintaining unidirectional blood flow and preventing emboli formation, which can lead to severe complications such as stroke or tissue ischemia due to the invasive nature of traditional surgeries and the risk of dislodging tissue and thrombi during the procedure.
Innovation Solution
A percutaneous temporary valve system with an integrated or separate embolic protection feature, comprising a temporary valve and a filter unit that can be deployed to maintain blood flow in one direction and trap emboli, using a central core and sheath configuration that allows for everted deployment and optional use with a catheter for delivering permanent prosthetic valves or repair tools.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If a percutaneous valve repair or replacement procedure is performed, then minimally invasive treatment is achieved, but the risk of dislodging tissue and thrombi leading to emboli formation increases
Solution Approach 1:
The device is divided into two functional segments: a valve component for maintaining unidirectional blood flow and a filter component for trapping emboli. This segmentation allows each component to perform its specific function effectively while working together as an integrated system during percutaneous procedures
Solution Approach 2:
The filter acts as an intermediary between the manipulation zone (where tissue and thrombi may be dislodged) and the circulatory system. It intercepts emboli before they can travel through the circulation, providing protection while allowing the percutaneous procedure to proceed
2Reliability
If traditional open chest surgery is performed for valve replacement, then complete valve replacement is achieved, but the invasiveness and recovery time increase significantly
Solution Approach 1:
Instead of opening the chest cavity and accessing the heart directly through a large incision (traditional approach), the device is inverted in its deployment strategy: it is delivered percutaneously through a small vascular access point and then deployed inside the heart, reversing the traditional surgical pathway and achieving both minimally invasive access and effective valve replacement
3Reliability
If a temporary valve is used during percutaneous procedure, then unidirectional blood flow is maintained, but the complexity of the procedure increases
Solution Approach 1:
The temporary valve and embolic filter are merged into a single integrated device, eliminating the need to implant separate components. This combination maintains unidirectional blood flow while simultaneously providing emboli protection, reducing procedural steps and overall complexity compared to using separate devices
Data Source
Figure 1~1A
Figure 2~2A
Figure 3
AI summary
A temporary percutaneous valve-filter device having valve portions non-porous to blood and filter portions non-porous to emboli but at least in part porous to blood. In one embodiment, the device has a substantially flat valve unit and a substantially flat filter unit. In another embodiment, the device has at least one open umbrella deployed configuration. In one aspect, the device has a unitary construction with one umbrella canopy with one or more filter areas with flaps allowing unidirectional blood flow. In another aspect, the device has a valve unit and filter unit, the umbrella canopies oriented in opposite directions, and the valve unit "closes" and opens to allow blood to flow to one direction. Also provided is a temporary valve system, including a core having an inverted delivery configuration and everted deployed configuration, that may be used with or without a filter unit, and a method of deployment.