Radiofrequency Perforation Apparatus with Gradient Insulator
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Solution Overview
Problem
Current radiofrequency perforation devices face challenges in efficiently creating channels in tissues with minimal tissue damage and maintaining ergonomic feedback during the procedure.
Innovation Solution
A radiofrequency perforation apparatus with a tubular member and an end member featuring a thin, atraumatic electrode and electrical insulator, designed for precise energy delivery and tactile feedback, is developed. The apparatus includes a distal tip for targeting and a curved section for enhanced positioning, utilizing materials like stainless steel and nickel-titanium alloys for structural integrity and flexibility.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Productivity
If a radiofrequency electrode is used to create channels in tissue, then channel creation efficiency is improved, but tissue trauma increases
Solution Approach 1:
The patent applies local quality by creating a gradient in insulator thickness along the electrode. The insulator is thinnest at the distal tip where channel creation is needed, allowing focused RF energy delivery with minimal trauma, while being thicker proximally to prevent unwanted energy delivery and tissue damage along the shaft. This spatial variation in insulator thickness enables selective tissue interaction.
Solution Approach 2:
The patent changes the parameter of insulator thickness to control RF energy delivery. By varying the insulator thickness from distal to proximal regions, the electrode can deliver high energy density at the tip for efficient channel creation while maintaining lower energy delivery elsewhere to minimize tissue trauma. The insulator thickness parameter directly controls the balance between productivity and tissue damage.
2Object-affected harmful factors
If a thin electrode is used to reduce trauma, then tissue damage is minimized, but structural integrity deteriorates
Solution Approach 1:
The patent uses composite materials by combining a thin electrode core with an insulating material coating. The thin electrode (e.g., 0.1-0.3mm diameter) provides minimal tissue trauma, while the insulator layer (with varying thickness) provides structural support and protects the fragile electrode. The composite structure allows the thin electrode to maintain both low trauma characteristics and sufficient mechanical strength for catheter navigation.
Solution Approach 2:
The insulator thickness varies locally along the electrode shaft, being thinnest at the distal tip and thicker proximally. This local variation provides structural reinforcement where needed while maintaining electrode flexibility and minimal trauma at the active site. The gradient structure optimizes both strength and tissue compatibility.
3Measurement precision
If an insulator covers the electrode to control energy delivery, then energy precision is improved, but tactile feedback deteriorates
Solution Approach 1:
The patent changes the insulator thickness parameter to balance energy precision and tactile feedback. The insulator is made extremely thin (e.g., 1-10 micrometers) at the distal tip, which allows precise control of RF energy delivery while still permitting mechanical coupling between the electrode and tissue for tactile feedback. The thin insulator maintains electrical isolation while allowing mechanical interaction.
4Strength
If the tubular member thickness is increased to improve structural integrity, then device strength is improved, but flexibility deteriorates
Solution Approach 1:
The patent optimizes the tubular member thickness parameter to achieve the desired balance between strength and flexibility. By carefully selecting the wall thickness (e.g., 0.05-0.4mm as specified in claims), the catheter maintains sufficient structural integrity to support the electrode and withstand manipulation forces, while remaining flexible enough to navigate vascular anatomy and conform to tissue surfaces.
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 apparatus effectively creates channels in tissues with reduced trauma and provides users with tactile feedback, maintaining the feel of traditional mechanical devices while improving safety and efficiency in procedures like atrial septum puncture.
Implementation Method 1
radiofrequency perforation apparatus for creating a channel at a target location in a body of a patient
Data Source
AI summary
A radiofrequency perforation apparatus for creating a channel at a target location in a body of a patient, the radiofrequency perforation apparatus comprising: a substantially tubular member defining a tubular member lumen; an end member partially positioned within the tubular member lumen at a distal end of the tubular member, the end member including an electrode; and an electrical insulator extending along the substantially tubular member.