Expandable Catheter with Flex-PCB Signal Paths

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Solution Overview

Problem

Current medical devices for cardiac mapping and ablation require separate systems and can be inaccurate due to tissue anisotropy and respiration, lacking a unified solution for precise electrical signal transmission and processing within the body.

Innovation Solution

A flexible printed circuit board (flex-PCB) substrate-based expandable catheter assembly with electronic elements and communication paths for signal transmission and processing, allowing for insertion into body lumens and expansion within heart chambers for dipole mapping and ablation procedures.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Device complexity

If separate systems are used for cardiac mapping and ablation, then device complexity is reduced, but measurement precision and treatment accuracy deteriorate

Engineering Contradiction:
Improvesystem complexityVSAvoidcardiac mapping accuracy
Core Design Contradiction:
Device complexityVSMeasurement precision

Solution Approach 1:

The patent combines cardiac mapping electrodes and ablation elements into a single integrated catheter assembly. The expandable basket structure incorporates both mapping electrodes on its arms and ablation elements at the distal end, allowing simultaneous or sequential performance of mapping and ablation procedures with one device, thereby improving measurement precision without proportionally increasing system complexity

Inventive Principle:
Principle #5Merging (Combining)

Solution Approach 2:

The catheter assembly is designed with multi-functionality, serving both as a mapping device with electrodes for electrical signal detection and as an ablation device with RF or cryo elements for tissue modification. This universal design allows a single device to perform multiple cardiac intervention functions, resolving the contradiction between system simplicity and measurement accuracy

Inventive Principle:
Principle #6Universality (Multi-functionality)

2Stability of the object's composition

If rigid structures are used for catheter support, then structural stability is improved, but adaptability to body lumens and heart chambers deteriorates

Engineering Contradiction:
Improvecatheter structural stabilityVSAvoidadaptability to body lumens
Core Design Contradiction:
Stability of the object's compositionVSAdaptability or versatility

Solution Approach 1:

The catheter employs a dynamic structure that can transition between a compressed delivery state and an expanded operational state. The expandable basket arms are designed to be flexible during navigation through body lumens and then expand within the heart chamber to provide structural stability for electrode positioning and ablation element deployment, thus achieving both adaptability and stability

Inventive Principle:
Principle #15Dynamics

Solution Approach 2:

The catheter incorporates flexible materials and thin-walled structures in the shaft and basket arms that allow the device to conform to the contours of body lumens and heart chambers during insertion and positioning, while still maintaining sufficient structural integrity to support the electronic elements and enable stable mapping and ablation procedures

Inventive Principle:
Principle #30Flexible shells and thin films

3Measurement precision

If multiple electronic elements are integrated on flex-PCB substrate, then measurement precision and signal processing capability are improved, but device complexity increases

Engineering Contradiction:
Improveelectrical signal detection accuracyVSAvoidelectronic element integration complexity
Core Design Contradiction:
Measurement precisionVSDevice complexity

Solution Approach 1:

The patent utilizes a flexible printed circuit board (flex-PCB) substrate to mount multiple electronic elements including electrodes, RF ablation elements, and sensing components. The flex-PCB technology allows for compact integration of these elements with pre-fabricated electrical pathways, reducing the complexity of wiring and connections while enabling high-precision electrical signal detection and processing across multiple measurement points

Inventive Principle:
Principle #30Flexible shells and thin films

Solution Approach 2:

The patent replaces traditional mechanical wiring and connection systems with integrated flex-PCB electrical pathways. This substitution reduces the mechanical complexity of connecting multiple electronic elements while improving electrical signal integrity and measurement precision through consistent, rigidified electrical traces that are less susceptible to movement-induced signal variations

Inventive Principle:
Principle #28Mechanics substitution (Replace mechanical system)

4Measurement precision

If expandable assembly is used within heart chambers, then measurement precision and treatment effectiveness are improved, but device complexity and procedural difficulty increase

Engineering Contradiction:
Improvecardiac mapping accuracyVSAvoidprocedural ease
Core Design Contradiction:
Measurement precisionVSEase of operation

Solution Approach 1:

The expandable basket is segmented into multiple arms that can independently position mapping electrodes and ablation elements against the cardiac wall. This segmentation allows the device to conform to the three-dimensional geometry of heart chambers, improving measurement precision by enabling simultaneous contact at multiple locations, while the modular segmented design simplifies the expansion and contraction mechanism for easier operation

Inventive Principle:
Principle #1Segmentation

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

Enables precise electrical signal processing and transmission within the body, improving the accuracy of cardiac mapping and ablation procedures by integrating multiple electronic elements and ultrasound transducers on a flexible PCB substrate, addressing the limitations of existing systems.

Implementation Method 1

a plurality of ultrasound transducers coupled to the flex-PCB substrate and configured to transmit an ultrasound signal

Methodology Applied
Scientific EffectUltrasound: Ultrasound

Implementation Method 2

a plurality of electrodes coupled to the flex-PCB substrate and configured to detect an electrical signal

Methodology Applied
Scientific EffectElectrical conduction: Conduction (electrical)

Data Source

PatentUS20230218231A1Expandable catheter assembly with flexible printed circuit board (PCB) electrical pathways
Publication Date: 2023.07.13 ENCHANNEL MEDICAL LTD
  • US20230218231A1 patent drawing
  • US20230218231A1 patent drawing
  • US20230218231A1 patent drawing

AI summary

Provided is a flex-PCB catheter device that is configured to be inserted into a body lumen. The flex-PCB catheter comprises an elongate shaft, an expandable assembly, a flexible printed circuit board (flex-PCB) substrate, a plurality of electronic components and a plurality of communication paths. The elongate shaft comprises a proximal end and a distal end. The expandable assembly is configured to transition from a radially compact state to a radially expanded state. The plurality of electronic elements are coupled to the flex-PCB substrate and are configured to receive and/or transmit an electric signal. The plurality of communication paths are positioned on and/or within the flex-PCB substrate. The communication paths selectively couple the plurality of electronic elements to a plurality of electrical contacts configured to electrically connect to an electronic module configured to process the electrical signal. The flex-PCB substrate can have multiple layers, including one or more metallic layers. Acoustic matching elements and conductive traces can be includes in the flex-PCB substrate.