RF Toggle Catheter for Arteriovenous Fistula Creation
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Solution Overview
Problem
Current methods for creating arteriovenous fistulas in medical practice are cumbersome, require extensive dissection, and cause pain, with a need for quick, reliable, and precise connections between arteries and veins for hemodialysis, which often result in twisted vessels and inadequate flow rates.
Innovation Solution
A device and method utilizing a piercing member with a toggle mechanism and RF or resistive heat energy to create an elongated communicating aperture between adjacent blood vessels, allowing for precise alignment and sealing of the fistula, reducing tissue damage and promoting hermetic sealing.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Productivity
If traditional surgical methods are used to create arteriovenous fistulas, then the connection can be established between artery and vein, but the process requires extensive dissection, causes pain, and results in twisted vessels with inadequate flow rates
Solution Approach 1:
The patent replaces traditional mechanical surgical dissection with RF energy-based tissue cutting and sealing. The RF electrode creates the fistula tract through thermal energy, eliminating the need for extensive surgical dissection and manual vessel manipulation, thereby reducing surgical complexity while maintaining productivity
Solution Approach 2:
The patent utilizes RF energy to change the thermal parameters of the tissue, creating a controlled thermal field that cuts and seals the vessels simultaneously. This parameter change approach allows for rapid fistula creation without the mechanical trauma of traditional surgery, improving both speed and ease of operation
2Manufacturing precision
If hand-sewn anastomosis is used to connect vessels, then the connection can be made, but the process is time-consuming and may result in twisted vessels
Solution Approach 1:
The patent replaces manual hand-sewn anastomosis with RF energy-based tissue fusion. The RF electrode creates precise thermal bonds between vessel walls, eliminating the need for time-consuming suturing while maintaining accurate vessel alignment through controlled energy delivery
Solution Approach 2:
The RF energy system performs both cutting and sealing functions simultaneously through the same electrode. The tissue naturally fuses as the RF energy progresses through it, eliminating the need for separate alignment and suturing steps, thereby reducing surgery duration while maintaining precision
3Reliability
If prosthetic grafts are used to create arteriovenous connections, then the connection can be established, but two anastomoses are required which increases surgical complexity
Solution Approach 1:
The patent extracts the need for prosthetic grafts entirely by creating a direct arteriovenous fistula through RF energy. This eliminates the requirement for two separate anastomoses (artery-to-graft and graft-to-vein), reducing device complexity to a single energy-delivery electrode while maintaining reliable high-flow access
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 rapid, reliable, and precise creation of arteriovenous fistulas with improved flow rates, minimizing tissue damage and ensuring effective access for hemodialysis by creating a smooth, sealed connection between arteries and veins.
Implementation Method 1
A device and method utilizing a piercing member with a toggle mechanism and RF or resistive heat energy to create an elongated communicating aperture between adjacent blood vessels
Implementation Method 2
A device and method utilizing a piercing member with a toggle mechanism and RF or resistive heat energy to create an elongated communicating aperture between adjacent blood vessels
Implementation Method 3
A third member extends from a distal end of the piercing member and is actuatable to move adjacent first and second blood vessels toward one another
Data Source
AI summary
A system for creating an arteriovenous (AV) fistula comprises a vessel access sheath having a hollow interior and an exit port, a side access needle catheter configured to fit within the hollow interior of the sheath, a needle configured to be inserted into a blood vessel through the side access needle catheter, a toggle delivery catheter configured to fit within the hollow interior of the sheath, and a toggle apparatus configured to be delivered into a vessel through the toggle delivery catheter. The toggle apparatus comprises a shaft and a toggle member pivotably attached to a distal end of the shaft. A source of RF energy or resistive heat energy may be provided for application to the toggle member and/or to a heater insert in the toggle delivery catheter, for the purpose of creating the fistula.