Flexible Toroidal Balloon Catheter for Conformable Cardiac Ablation

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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 is time-consuming and complex.

Innovation Solution

A cardiac tissue ablation catheter with an inflatable and flexible toroidal or spherically shaped balloon and a flexible circuit with multiple branches, each carrying a substrate with a conductive trace and an ablation electrode, allowing for conformability and efficient energy transmission over large surfaces.

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 and bulkiness increase limiting conformability

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 controllable electrode segments or groups that can be selectively activated. This segmentation allows the large electrode array to conform to complex anatomies by activating only the necessary portions while maintaining flexibility during delivery.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The catheter incorporates flexible materials and dynamic structures that allow the electrode array to change from a compact delivery configuration to an expanded treatment configuration. The device can dynamically adapt its shape to match the complex 3-D anatomy of pulmonary vein antra while maintaining structural integrity.

Inventive Principle:
Principle #15Dynamics

2Device complexity

If single electrode tip catheter technique is used, then device simplicity is maintained, but procedure time increases due to point to point manipulation

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

Solution Approach 1:

Multiple electrodes are merged into a single catheter shaft, allowing simultaneous energy delivery at multiple locations along the pulmonary vein antrum. This combines the simplicity of a single catheter with the efficiency of multi-point ablation, reducing the need for repeated repositioning.

Inventive Principle:
Principle #5Merging (Combining)

Solution Approach 2:

The catheter is designed with pre-positioned electrodes that are already in place during delivery, eliminating the need for sequential positioning of individual electrodes. The electrodes are preliminarily arranged to cover the target anatomy, allowing immediate ablation upon contact.

Inventive Principle:
Principle #10Preliminary action

3Manufacturing precision

If multiple catheters are placed in left atrium for complete mapping, then mapping completeness is improved, but device complexity and skill requirements increase

Engineering Contradiction:
Improvemapping completenessVSAvoidnumber of catheters and steering system
Core Design Contradiction:
Manufacturing precisionVSDevice complexity

Solution Approach 1:

The catheter incorporates multiple functions including mapping electrodes, ablation electrodes, and sensing capabilities within a single device. This multi-functional design eliminates the need for separate mapping and ablation catheters, reducing overall system complexity while maintaining complete mapping capability.

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

Solution Approach 2:

The catheter design nests multiple electrode arrays and functional components within a single catheter shaft, with electrodes arranged in concentric or layered configurations. This nested structure allows complete anatomical coverage while maintaining a streamlined single-catheter profile.

Inventive Principle:
Principle #7Nested doll (Nesting)

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 provides superior apposition to the target site, reduces procedure time, and minimizes skill requirements by allowing for larger surface area lesions with reduced collateral damage and improved conformability to complex anatomies.

Implementation Method 1

RF and acoustic energy fields... generate energy fields within the tissue which in turn generate heat

Methodology Applied
Scientific EffectJoule heating: Joule Heating

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 EffectThermal ablation: Ablation

Data Source

PatentUS11744639B2Ablation catheters
Publication Date: 2023.09.05 SHIFAMED HLDG LLC
  • US11744639B2 patent drawing
  • US11744639B2 patent drawing
  • US11744639B2 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.