Intravascular Tissue-Welding Catheter for AV Fistula Alignment
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Solution Overview
Problem
Current medical practices for creating arteriovenous fistulas for hemodialysis are cumbersome, require extensive dissection, and often result in twisted or improperly sized anastomoses, leading to inefficiencies and patient discomfort.
Innovation Solution
A device with angled heating assemblies and a retractable distal tip is used to create an arteriovenous fistula by applying controlled heat and pressure to vessels, ensuring precise alignment and welding without extensive dissection, utilizing a serpentine heating element and passive heat spreader for controlled tissue desiccation and adhesion.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If traditional surgical methods are used to create arteriovenous fistulas, then the anastomosis can be securely connected, but the procedure requires extensive dissection and results in twisted or improperly sized anastomoses
Solution Approach 1:
The patent replaces traditional mechanical suture-based anastomosis with a thermal welding system. Heating elements within the catheter apply controlled heat to fuse the vessel walls directly, eliminating the need for extensive dissection and suturing. This thermal mechanism substitutes the mechanical manipulation that caused twisting and sizing problems.
Solution Approach 2:
The invention changes the fundamental parameter of tissue joining from mechanical (sutures) to thermal (heat). By controlling temperature parameters through heated balloons or heating elements, the system achieves reliable anastomosis formation without the mechanical constraints that limited traditional methods. The heat welding process allows for precise control of anastomosis size and shape.
2Reliability
If hand suturing is used to create anastomoses, then the vessels can be joined together, but the process is time-consuming and requires extensive dissection
Solution Approach 1:
The patent replaces the time-consuming mechanical suture process with rapid thermal welding. The heating elements or heated balloons create instantaneous fusion of vessel walls, reducing the procedural time from hours of suturing to minutes of thermal application. This substitution maintains reliable vessel joining while dramatically improving productivity.
Solution Approach 2:
The catheter delivers heating elements or heated balloons directly to the anastomosis site through the vasculature, performing the joining action at the precise location without requiring preliminary dissection. The thermal welding action is applied immediately at the target site, eliminating the time required for surgical exposure and manual suturing.
3Reliability
If traditional anastomosis methods are used, then the connection can be established, but the anastomosis may be twisted or improperly sized leading to patient discomfort
Solution Approach 1:
The invention uses thermal parameters to precisely control anastomosis formation. The temperature, duration, and distribution of heat are controlled to create uniformly sized and properly aligned connections. This thermal parameter control eliminates the twisting and sizing variations that occur with manual suturing techniques.
Solution Approach 2:
The heating elements or heated balloons apply thermal energy locally and uniformly across the anastomosis site, ensuring consistent tissue fusion throughout the connection area. This localized thermal application guarantees uniform anastomosis quality without the variability inherent in hand-sewn connections, preventing twisting and improper sizing.
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 device enables quick, reliable, and minimally invasive creation of arteriovenous fistulas with optimal size and alignment, reducing patient discomfort and procedural time, while maintaining high flow rates necessary for hemodialysis access.
Implementation Method 1
A first heating assembly, comprising an energized heating element, is disposed on at least one of the distal tapered end surface and the proximal tapered end surface
Implementation Method 2
A second heating assembly, comprising a passive non-energized heat spreader, is disposed on the other one of the distal tapered end surface and the proximal tapered end surface
Data Source
AI summary
A device for creating an arteriovenous (AV) fistula includes a proximal base having a distal tapered end surface and a distal tip connected to the proximal base and movable relative to the proximal base. The distal tip has a proximal tapered end surface. A first heating assembly, including an energized heating element, is disposed on at least one of the distal tapered end surface and the proximal tapered end surface. A second heating assembly, comprising a passive non-energized heat spreader, is disposed on the other one of the distal tapered end surface and the proximal tapered end surface. The distal tapered end surface and the proximal tapered end surface are adapted to contact opposing sides of a tissue portion to create the fistula. The taper of the proximal tapered end surface matches the taper of the distal tapered end surface, so that the two surfaces match one another.