Catheter Spine Microelectrode Assembly for Near-Field Detection
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Solution Overview
Problem
Existing electrophysiology catheters face challenges in achieving precise and consistent spacing of closely-spaced electrode pairs, leading to issues with noise detection and far-field signal interference, and conventional methods risk electrode detachment or breakage due to stress from lead wire attachment angles.
Innovation Solution
The catheter features a distal electrode assembly with divergent spines carrying closely-spaced bipole microelectrodes, separated by gaps of 300 microns or less, and a flexible microelectrode panel on each spine, using shape-memory alloys for support and a preformed curvature to ensure consistent tissue contact and minimize noise exposure.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Manufacturing precision
If conventional adhesive methods are used to seal ring electrodes, then assembly is simplified, but electrode spacing cannot be reduced below 1.0 mm due to adhesive margin requirements
Solution Approach 1:
The patent replaces conventional adhesive sealing methods with a mechanical constraint system using a constraint member that physically limits electrode displacement. This substitution eliminates the need for adhesive margins, enabling sub-1.0 mm electrode spacing while maintaining assembly simplicity through the constraint member's inherent mechanical guidance during the pouring process.
Solution Approach 2:
The constraint member acts as an intermediary element between the electrode assembly and the pouring medium. It provides a mechanical interface that controls electrode positioning during assembly, allowing precise spacing without requiring complex adhesive application procedures or leaving margin gaps.
2Measurement precision
If electrode spacing is reduced to 0.2 or 0.1 mm for better signal detection, then near-field potential detection improves, but adjacent electrodes may contact due to tolerance accumulation and electrode shifting during assembly
Solution Approach 1:
The constraint member provides beforehand cushioning by pre-establishing mechanical limits on electrode displacement before assembly errors can occur. During the pouring process, the constraint member physically prevents electrodes from shifting beyond predetermined boundaries, accommodating tolerance variations without causing contact between adjacent electrodes.
Solution Approach 2:
The invention changes the controlling parameter for electrode spacing from adhesive-based margin requirements to constraint-member-based mechanical limits. This parameter change enables tighter spacing (0.2-0.1 mm) by using the constraint member's geometry to define precise electrode positions, eliminating the spacing safety margins required by adhesive methods.
3Ease of manufacture
If lead wires are attached at acute angles to reach ring electrodes, then electrode connectivity is achieved, but stress concentration occurs leading to detachment or breakage
Solution Approach 1:
The constraint member performs preliminary action by establishing proper electrode alignment and positioning before lead wire attachment occurs. By pre-positioning electrodes in a configuration that accommodates gradual lead wire routing, the system eliminates the need for acute-angle attachments that create stress concentrations, thereby preventing detachment or breakage.
4Measurement precision
If closely-spaced bipole microelectrodes are used to detect near-field potentials, then far-field signal interference is reduced, but manufacturing and assembly precision requirements increase significantly
Solution Approach 1:
The patent replaces complex precision manufacturing requirements with a mechanical constraint system. Instead of relying on precise manufacturing to achieve consistent sub-1.0 mm spacing, the constraint member provides mechanical guidance during assembly that automatically ensures consistent electrode spacing, making the process robust to manufacturing variations.
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
This design allows for accurate detection of near-field signals, reducing noise and far-field interference, enabling precise targeting of myocardial tissue and improving therapeutic delivery by accurately determining pulmonary vein potentials and anatomical locations.
Implementation Method 1
Each spine may be formed from a shape-memory alloy and may have a preformed curvature
Implementation Method 2
The catheter features a distal electrode assembly with divergent spines carrying closely-spaced bipole microelectrodes
Data Source
Figure 1
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Figure 4
AI summary
An electrophysiologic catheter (10) with a distal electrode assembly (15) carrying very closely-spaced bipole microelectrodes (85) on a plurality of divergent spines (42) that can flexibly spread over tissue surface area minimized detection of undesirable noise, including far-field signals. Each spine has a flexible microelectrode panel (80) having a substrate, at least one pair of microelectrodes, a trace for each microelectrode, and a soldering pad. Adjacent microelectrodes of a bipole pair are separated by a space gap distance ranging between about 50-300 microns. Each microelectrode may have a width of about 200 or 300 microns.