Bipolar Sphincterotome with Conductive Ink Return Path
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Solution Overview
Problem
Current sphincterotomes for performing sphincterotomy lack an effective bipolar configuration that ensures proper electrical conduction and visualization during the procedure, leading to potential inefficiencies and complications in cutting the sphincter muscle.
Innovation Solution
A bipolar sphincterotome design featuring an elongate tubular member with a cutting wire and a return path that includes a conductive material portion on its outer surface, providing a visual access to a wire guide lumen, and a return wire within the tubular member, allowing for efficient electrical conduction and visualization during sphincterotomy.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a traditional monopolar sphincterotome is used, then the cutting function is achieved, but the electrical conduction path is long and passes through the patient's body, increasing safety risks
Solution Approach 1:
The electrical conduction path is segmented into two separate return paths instead of one long path through the patient's body. Each return path is contained within the catheter structure, dividing the conduction into shorter, isolated segments that reduce safety risks while maintaining functional simplicity
Solution Approach 2:
The return paths are nested within the catheter structure, with conductive material portions disposed on the outer surface and return wires disposed within the tubular member. This nesting consolidates the electrical conduction system within the device itself, reducing external complexity while improving safety
2Reliability
If the return path is configured within the catheter, then safety is improved, but the device structure becomes more complex
Solution Approach 1:
The outer surface of the catheter serves multiple functions: it provides structural support, enables visualization through transparency, and carries the conductive material portion for electrical conduction. This multi-functionality reduces the need for separate components, thereby reducing overall device complexity while maintaining safety improvements
Solution Approach 2:
The conductive material portion is selectively disposed on specific portions of the outer surface where electrical contact is needed, rather than uniformly covering the entire catheter. This localized approach minimizes material usage and structural complexity while ensuring adequate electrical conduction for the sphincterotomy procedure
3Reliability
If the conductive material covers the entire outer surface, then electrical conduction is optimized, but visualization of the wire guide lumen is blocked
Solution Approach 1:
The conductive material portion is applied selectively to specific areas of the outer surface where electrical contact with the sphincter muscle is required, rather than covering the entire surface. This localized application maintains adequate electrical conduction efficiency while leaving other areas transparent for visualization of the wire guide lumen and internal structures
Solution Approach 2:
Instead of applying conductive material uniformly across the entire outer surface (excessive action), the invention applies it partially only to the extent necessary for effective electrical conduction. This partial application suffices for the sphincterotomy function while preserving visual access through the transparent catheter wall
4Device complexity
If a single return path is used, then the device is simpler, but the sphincterotomy precision and effectiveness are reduced
Solution Approach 1:
The electrical conduction system is segmented into multiple return paths (first and second return paths) with separate conductive material portions and return wires. This segmentation allows for more precise control and distribution of electrical current across the cutting wire, improving sphincterotomy precision and effectiveness while managing device complexity through organized modular structure
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 bipolar configuration enhances the precision and effectiveness of sphincterotomy by ensuring proper electrical conduction and visualization, reducing the risk of complications and improving the overall procedure.
Implementation Method 1
a return path. The return path includes a conductive material portion disposed on an outer surface at a distal portion of the tubular member, and a return wire electrically coupled to the conductive material portion
Data Source
AI summary
A bipolar sphincterotome may include an elongate tubular member, a cutting wire, and a return path. The return path may include a conductive ink portion disposed on an outer surface at a distal portion of the tubular member. The return path may also include a return wire disposed within the tubular member that is electrically coupled to the conductive ink portion. In some example embodiments, the return wire may be disposed within a lumen configured to have two or more functions, one of which being to house the return wire. Additionally, in some example embodiments, the conductive ink portion may be circumferentially disposed on the outer surface to provide visual access to a wire guide lumen. Also, for some example embodiments, the bipolar sphincterotome may include two electrically isolated return paths.