Flexible Balloon Ablation Catheter with Conformable Circuit

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Solution Overview

Problem

Existing cardiac ablation catheters are bulky, stiff, and inefficiently packed, limiting their ability to conform to complex 3-D anatomy and requiring multiple repositioning and overlapping patterns for effective ablation, which increases procedure time and complexity.

Innovation Solution

A cardiac tissue ablation catheter with an inflatable and flexible toroidal or spherically shaped balloon and a flexible circuit with radially outer branches, allowing for large surface area contact and conformability to tissues, along with a guidewire lumen and irrigation holes for efficient energy delivery.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Area of stationary object

If larger electrode arrays are used for one shot ablation, then lesion area is increased, but device stiffness increases and conformability to complex 3-D anatomy deteriorates

Engineering Contradiction:
Improvelesion areaVSAvoidconformability to complex 3-D anatomy
Core Design Contradiction:
Area of stationary objectVSAdaptability or versatility

Solution Approach 1:

The electrode array is divided into multiple independently movable segments or sections. Each segment can be independently positioned and shaped to conform to different anatomical surfaces, allowing the overall device to achieve both large lesion area and adaptability to complex 3-D anatomy without requiring the entire array to be rigidly fixed in one configuration.

Inventive Principle:
Principle #1Segmentation

2Device complexity

If single electrode tip catheter technique is used, then device simplicity is maintained, but procedure time increases and operational complexity increases

Engineering Contradiction:
Improvedevice simplicityVSAvoidprocedure time
Core Design Contradiction:
Device complexityVSProductivity

Solution Approach 1:

Multiple electrode tips are integrated into a single catheter body, allowing simultaneous ablation at multiple locations. This merging of multiple functional elements into one device maintains relative simplicity of the overall catheter structure while dramatically reducing procedure time by creating multiple ablation lesions in parallel rather than requiring sequential point-to-point manipulation.

Inventive Principle:
Principle #5Merging (Combining)

3Measurement precision

If multiple catheters are placed in the left atrium, then mapping precision is improved, but device complexity and procedure complexity increase

Engineering Contradiction:
Improvemapping precisionVSAvoidprocedure complexity
Core Design Contradiction:
Measurement precisionVSDevice complexity

Solution Approach 1:

The catheter is designed with multi-functional capabilities, integrating both mapping electrodes and ablation electrodes in a single device. This allows the same catheter to perform both diagnostic mapping and therapeutic ablation functions, eliminating the need for separate mapping catheters and ablation catheters, thereby reducing procedural complexity while maintaining mapping precision.

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

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 catheter achieves superior apposition to the target site, reduces procedure time, and minimizes the skill level required for successful ablation by providing a flexible and efficient energy transmission system for treating cardiac conditions.

Implementation Method 1

an inflatable and flexible toroidal or spherically shaped balloon

Methodology Applied
Scientific EffectElasticity: Elasticity

Implementation Method 2

thermal ablation therapy can be used to heat a target tissue with a surgical instrument such as a needle or probe electrode coupled to an energy source that heats the probe tip, the target tissue, or both

Methodology Applied
Scientific EffectJoule heating: Joule Heating

Implementation Method 3

Energy fields commonly used to create heat indirectly are RF and acoustic energy fields

Methodology Applied
Scientific EffectRF energy field: Electromagnetic Induction

Implementation Method 4

The guidewire is received within a guidewire lumen of the catheter shaft

Methodology Applied
Scientific EffectFriction: Friction

Data Source

PatentUS9655677B2Ablation catheters including a balloon and electrodes
Publication Date: 2017.05.23 SHIFAMED HLDG LLC
  • US9655677B2 patent drawing
  • US9655677B2 patent drawing
  • US9655677B2 patent drawing

AI summary

Cardiac tissue ablation catheters including an inflatable and flexible toroidal or spherically shaped balloon disposed at a distal region of an elongate member, a flexible circuit carried by an outer surface of the balloon, the flexible circuit including, a plurality of flexible branches conforming to the radially outer surface of the balloon, each of the plurality of flexible branches including a substrate, a conductive trace carried by the substrate, and an ablation electrode carried by the substrate, the ablation electrode in electrical communication with the conductive trace, and an elongate shaft comprising a guidewire lumen extending in the elongate member and extending from a proximal region of the inflatable balloon to distal region of the inflatable balloon and being disposed within the inflatable balloon, wherein a distal region of the elongate shaft is secured directly or indirectly to the distal region of the inflatable balloon.