Flexible Bipolar Electrode for GI Tract Ablation
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Solution Overview
Problem
There is a need for an electrode that can deliver bipolar energy effectively, is flexible and strong, maintains good contact with tissue regardless of orientation, and is easy to manufacture at low cost, particularly for applications requiring elongate or planar energy delivery patterns.
Innovation Solution
A flexible bipolar electrode with a non-conductive core and two conductors twisted together to form a spiral structure, allowing for alternating electrical poles along its length, which can be easily manufactured using methods like injection molding or 3D printing.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If two parallel wires are used as bipolar electrodes, then bipolar energy delivery is achieved, but the electrode structure becomes complex and difficult to manufacture with consistent spacing
Solution Approach 1:
The patent combines two separate wire functions into a single integrated structure. The insulated wire contains both conductors within one element, eliminating the need for separate wire placement and spacing maintenance. This merging resolves the manufacturing complexity while maintaining reliable bipolar energy delivery through the insulated construction.
Solution Approach 2:
The insulation layer acts as an intermediary element that enables bipolar electrode function within a single wire structure. The insulation selectively exposes conductors at specific locations to create alternating poles when the wire contacts tissue, solving the spacing and alignment problems of parallel wire configurations while maintaining manufacturing simplicity.
2Shape
If flexible PCB is used for elongate electrode pattern, then energy delivery in elongate pattern is achieved, but flexibility in direction parallel to PCB is extremely limited
Solution Approach 1:
The patent uses a flexible wire structure instead of a rigid PCB to create the elongate electrode pattern. The wire's inherent flexibility allows it to be inserted through small lumens and conform to various anatomical structures, achieving both the elongate energy delivery pattern and the required flexibility for different deployment orientations.
3Manufacturing precision
If parallel wires with spacers are used, then constant distance between poles is maintained, but the electrode design becomes complex and contact consistency with tissue is difficult to achieve
Solution Approach 1:
The patent merges the spacing function into the wire's insulation structure itself. The insulation thickness and conductor arrangement within the single wire inherently maintain constant distance between poles, eliminating the need for separate spacers and reducing overall design complexity while preserving manufacturing precision.
4Ease of operation
If thin and flexible electrode is used, then ease of insertion into small lumens is improved, but structural strength may be compromised
Solution Approach 1:
The patent uses a composite structure combining conductive materials with insulation material in a single wire. This composite construction provides both the flexibility needed for insertion into small lumens and the structural strength required for reliable energy delivery, as each material contributes its optimal properties to the overall electrode performance.
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 electrode provides reliable and controlled bipolar energy delivery, maintaining consistent contact with tissue and allowing for flexible deployment in various anatomical orientations, while being cost-effective to produce.
Implementation Method 1
Alternating Current (AC) Radiofrequency (RF), Direct Current (DC), or microwave energy may be delivered between the two poles, through the tissue or material, causing tissue effects. These effects may be minimal, transient changes in (e.g. cellular membrane potential modification as in nerve or cardiac stimulation), or warming accompanied by permanent tissue changes - ranging from protein coagulation, through triggering of cellular apoptosis mechanisms followed by scarring, to complete tissue fulguration and evaporation.
Data Source
Figure 1A~2A
Figure 2B~2C
Figure 2D~2E
AI summary
A flexible bipolar electrode is provided, with alternating poles positioned over a flexible member. A preferred embodiment may comprise two insulated conductors twisted together to form a twisted-pair, braid, or other similar structure, with the insulation removed at one or more locations along this structure, such that there exist adjacent conductors which have areas that are exposed. The one or more such locations where the insulation on each of the conductors is removed form a bipolar pair on at least one of the sides of the electrode. The exposed locations of the two conductors may form focal points, lines, or areas of alternating poles, and may be used for delivering energy to target tissue or material according to those shapes, to affect the tissue or material at those points, lines, or areas. Use of such electrode as well as additional technologies for treating GI conditions including but not limited to obesity and constipation is further described. The current invention describes methods and devices for treating obesity and other gastrointestinal conditions, by producing ablation patterns on the gastric wall. The ablation patterns may comprise ablation lesions through which propagation of electrical, neural, or hormonal activity may be reduced or otherwise modified. By modifying this propagation, the ablation patterns may modify the behavior of the organ as a whole.