Endovascular Valve Formation with Integrated Imaging
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Solution Overview
Problem
Current treatments for venous reflux, particularly in deep veins, are invasive, have lengthy recovery times, and do not effectively address the underlying issue of dysfunctional venous valves, with existing imaging technologies requiring complex setups and clear fluid paths for visualization.
Innovation Solution
A valve creation and imaging system that integrates imaging transducers with valve creation devices, allowing for real-time imaging and positional feedback during valve formation procedures within the vessel wall, using a combination of ultrasound and optical coherence tomography, with movable and expandable components for precise tissue manipulation and visualization.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If surgical repair or replacement of diseased valves is performed, then the venous reflux problem is addressed, but recovery time increases and surgical risks increase
Solution Approach 1:
The patent replaces open surgical mechanical manipulation with minimally invasive endovascular techniques. A catheter-delivered device is inserted through the femoral vein to create a valve within the diseased vein segment, eliminating the need for open surgical repair or replacement while reducing recovery time and surgical risks.
Solution Approach 2:
The patent introduces an intermediary device (the valve formation device with balloon catheter) that mediates between the surgical intervention and the venous reflux problem. This intermediary creates a functional valve within the vein wall, addressing the underlying issue without requiring traditional surgical valve replacement.
2Difficulty of detecting and measuring
If existing imaging technologies are used for guidance, then visualization is provided, but complex setups and clear fluid paths are required
Solution Approach 1:
The patent merges imaging capabilities directly with the valve formation device. Ultrasound transducers are integrated into the catheter assembly, allowing imaging guidance to be combined with the therapeutic intervention in a single device system, thereby reducing overall setup complexity while maintaining visualization capability.
Solution Approach 2:
The catheter device is designed with multi-functionality, serving both as the therapeutic valve formation tool and as the imaging guidance system. The integrated ultrasound transducers enable the same device to perform both imaging and treatment functions, eliminating the need for separate imaging equipment and simplifying the overall setup.
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
Enables minimally invasive, precise autologous valve formation with improved visualization and positional accuracy, reducing recovery times and addressing the underlying venous reflux issues by integrating imaging directly into the valve creation process.
Implementation Method 1
imaging transducers with valve creation devices, allowing for real-time imaging
Implementation Method 2
using a combination of ultrasound and optical coherence tomography
Data Source
AI summary
Endovascular valve formation systems with imaging capabilities and associated devices and methods are disclosed herein. In some embodiments, a valve formation and imaging system can include, for example, (i) a valve formation device configured to access a vessel wall and dissect a portion of the vessel wall to form an autologous valve leaflet and (ii) an imaging device configured to image the vessel wall and components of the valve formation device during a valve formation procedure. In some embodiments, the imaging device is integrated into a distal end portion of the valve formation device. In some embodiments, the imaging device is a separate catheter device positionally coupled to the valve formation device and/or components thereof.


