Bipolar Coagulating Device with Rigidly Resilient Polymeric Handpiece
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Solution Overview
Problem
Current treatments for varicose veins, such as sclerotherapy and endovenous thermal ablation, have limitations including potential for recurrence, side effects like scarring and nerve injury, and the need for skilled surgical professionals and prolonged recovery times.
Innovation Solution
A novel bipolar coagulating device with a polymeric handpiece that delivers thermal RF energy and optimized compressive pressure to occlude and divide veins by coagulating tissue, reducing the need for sharp instruments and minimizing complications.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If sclerotherapy is used to treat varicose veins, then the procedure is simple and minimally invasive, but there is potential for recurrence and side effects like scarring and nerve injury
Solution Approach 1:
The patent replaces the mechanical injection process of sclerotherapy with a bipolar RF energy delivery system. The bipolar coagulating device uses alternating current to generate thermal energy that directly coagulates and seals the vein, eliminating the need for chemical sclerosing agents and their associated side effects while maintaining procedural simplicity
Solution Approach 2:
The patent changes the fundamental parameter of treatment from chemical (sclerosing agents) to thermal (RF energy). By controlling temperature, power, and duty cycle parameters of the bipolar RF device, the system achieves reliable vein occlusion without the recurrence and side effects associated with chemical methods
2Reliability
If endovenous thermal ablation is used to treat varicose veins, then recurrence is reduced, but the procedure requires skilled surgical professionals and prolonged recovery times
Solution Approach 1:
The patent extracts the complex catheter navigation and positioning requirements of endovenous thermal ablation by using a percutaneous clamp-based approach. The bipolar device is applied externally to the skin surface over the target vein, eliminating the need for venous access, catheter insertion, and complex intra-venous navigation while maintaining effective thermal ablation
Solution Approach 2:
The patent introduces a percutaneous clamp as an intermediary device that holds the bipolar RF electrodes in stable contact with the skin overlying the target vein. This clamp mechanism simplifies the procedure by providing mechanical stability and precise positioning without requiring surgical skills for catheter manipulation
3Strength
If conventional bipolar devices are used for coagulation, then the basic coagulation function is achieved, but they cannot effectively seal thicker tissue sections
Solution Approach 1:
The patent implements dynamic control of RF energy delivery with adjustable power levels, duty cycles, and pulse durations. The bipolar device can adapt its thermal output in real-time based on tissue thickness and composition, allowing effective sealing of both thin and thick tissue sections through programmable parameter adjustment
Solution Approach 2:
The patent employs a bipolar electrode design with composite construction featuring conductive elements for RF energy delivery and insulating materials for tissue isolation. This composite structure enables focused energy delivery to the target tissue while protecting surrounding areas, effectively sealing thicker tissue sections through controlled thermal penetration
4Manufacturing precision
If sharp instruments are used for vein division, then the division is clean and precise, but there is increased exposure to bodily fluids and higher risk of infection
Solution Approach 1:
The patent replaces sharp mechanical cutting instruments with bipolar RF energy for vein division. The RF energy coagulates and seals the vein tissue through thermal effect, achieving clean division without physical contact between sharp edges and blood, thereby reducing exposure to bodily fluids and infection risk while maintaining precise division
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 effectively seals thicker tissue sections, reduces scarring and nerve injury, minimizes recurrence, and allows for simpler, quicker procedures with fewer steps and less exposure to bodily fluids, thereby reducing the risk of infection.
Implementation Method 1
delivering a monophasic or biphasic RF current through a pair of oppositely-faced, coagulating jaws to a clamped tissue section positioned therebetween so as to coagulate the clamped tissue section
Implementation Method 2
optimized compressive pressure to occlude and divide veins by coagulating tissue
Data Source
AI summary
Conventional varicose vein techniques suffer from a number of disadvantages and potential complications, including, for example, a risk for the development of hematomas, swelling, and blood clots, post-surgical pain and nerve injury, a potential for spontaneous regeneration and undesired resumption of varicosity, a need for a highly skilled surgical professional, as well as, in certain instances, a prolonged recovery period, accompanied by severe limitations on post-surgical activity. The present invention overcomes the disadvantages and deficiencies of the prior art by providing devices and methods for percutaneously occluding and dividing a varicose vein or other problematic vessel, a rapid, reliable, less invasive therapy that may be readily, reliably, and successfully performed by minimally skilled personnel around the world in a variety of medical settings. Particularly described herein is a bipolar coagulating device provided with a rigidly resilient handpiece of unitary construction that is specifically adapted to the sealing of thicker tissue sections, whereby the stiffness of the handle material acts as a compressive spring to provide a predetermined clamping profile (i.e., force) and travel between the sealing jaws.