Tissue Welding Catheter for Precise AV Fistula Alignment
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Solution Overview
Problem
Current medical practices for creating arteriovenous fistulas for hemodialysis are time-consuming, require extensive dissection, and can cause pain, with a high risk of complications due to improper sizing and twisting of the anastomosis.
Innovation Solution
A device with angled heating assemblies and a retractable shaft is used to create an arteriovenous fistula by applying controlled heat and pressure to vessels, ensuring precise alignment and welding without cutting through tissue, utilizing a serpentine heating element and passive heat spreaders to promote adhesion and minimize tissue desiccation.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If traditional surgical methods are used to create arteriovenous fistulas with sutures and clips, then the anastomosis can be securely connected, but the procedure becomes time-consuming and requires extensive dissection
Solution Approach 1:
The patent replaces traditional mechanical suturing and clipping systems with a thermal welding system. Heating elements apply controlled heat to fuse tissue edges directly, eliminating the need for needles, threads, and clips. This substitution of mechanical fastening with thermal bonding achieves secure connections while dramatically reducing procedural time and complexity.
Solution Approach 2:
The invention controls the thermal parameters (temperature, duration, distribution) of the heating elements to achieve optimal tissue welding. By precisely adjusting these parameters, the system creates reliable anastomoses without excessive heat damage, replacing the variable control needed in manual suturing with programmable thermal parameters.
2Reliability
If traditional surgical dissection is performed to access and connect vessels, then the anastomosis can be created, but patient discomfort and risk of complications increase
Solution Approach 1:
The patent replaces extensive surgical dissection and manipulation with a minimally invasive thermal welding approach. The catheter-based delivery system requires only small access points, and the thermal welding process creates secure connections without the trauma of traditional surgical exposure, reducing patient discomfort and complication risks.
Solution Approach 2:
The patent introduces a catheter-based heating assembly as an intermediary tool that delivers thermal energy through a minimally invasive pathway. This intermediary system allows the creation of reliable anastomoses without requiring direct surgical exposure of the vessels, thereby reducing patient trauma while maintaining connection reliability.
3Productivity
If heating elements are applied to weld tissue, then rapid and reliable anastomosis creation is achieved, but tissue desiccation and damage may occur
Solution Approach 1:
The patent employs heating elements with specific geometric configurations (flat surfaces, angled surfaces, serpentine patterns) that concentrate thermal energy precisely at the tissue interface where welding is needed. This localized heat application achieves rapid welding while minimizing heat diffusion to surrounding tissues, preventing desiccation and damage.
Solution Approach 2:
The thermal welding process utilizes controlled phase transitions in tissue proteins, where localized heating denatures and fuses collagen and other structural proteins at the anastomosis site. This phase change mechanism enables rapid bonding while the controlled nature of the transition prevents excessive heat spread that would cause tissue desiccation.
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 rapid, reliable, and minimally invasive creation of arteriovenous fistulas with optimal flow rates, reducing procedural time and discomfort while ensuring strong, secure connections.
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.