Inflatable Pulmonary Vein Ablation Device for Selective Electric Field Delivery

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Solution Overview

Problem

There is an unmet need for thin, flexible, atraumatic devices that can effectively deliver high DC voltage electroporation ablation therapy selectively to endocardial tissue in regions of interest while minimizing damage to healthy tissue.

Innovation Solution

The development of systems, devices, and methods for ablating tissue through irreversible electroporation, which include a first and second shaft with electrodes and an inflatable member that transitions from an undeployed to a deployed configuration to engage the tissue wall and direct the electric field.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If high DC voltage is applied to deliver electroporation ablation therapy, then ablation effectiveness is improved, but damage to healthy tissue increases

Engineering Contradiction:

Improveablation effectivenessVSAvoiddamage to healthy tissue

Core Design Contradiction:

ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The patent applies local quality by making different portions of the inflatable member have different wall thicknesses. The middle portion has a minimum thickness that is less than the proximal and distal portions, creating localized regions of varying electrical insulation properties. This allows the electric field to be concentrated and directed specifically at the target tissue while limiting exposure to surrounding healthy tissue, thereby maintaining ablation effectiveness while reducing collateral damage.

Inventive Principle:

Principle #3Local quality

Solution Approach 2:

The inflatable member acts as an intermediary between the electrodes and the tissue. By positioning the inflatable member between the electrodes and the tissue wall, it provides controlled electrical insulation and directs the electric field toward the target tissue. The varying wall thickness creates zones of different field penetration, enabling selective ablation while protecting healthy tissue.

Inventive Principle:

Principle #24Intermediary (Mediator)

2Ease of operation

If the device structure is made thin and flexible for minimal invasiveness, then ease of delivery is improved, but structural strength deteriorates

Engineering Contradiction:

Improveease of deliveryVSAvoidstructural strength

Core Design Contradiction:

Ease of operationVSStrength

Solution Approach 1:

The inflatable member employs local quality through non-uniform wall thickness distribution. The middle portion has reduced thickness for flexibility and ease of delivery, while the proximal and distal portions have increased thickness for enhanced structural strength and protection during insertion and deployment. This localized variation resolves the contradiction between flexibility and strength.

Inventive Principle:

Principle #3Local quality

Solution Approach 2:

The patent utilizes a flexible inflatable member that can be collapsed into a thin profile for delivery through catheters, then inflated at the target site to provide the necessary structural support and electrical insulation. The flexible shell design enables minimal invasiveness during delivery while maintaining functional integrity during operation.

Inventive Principle:

Principle #30Flexible shells and thin films

3Ease of operation

If the inflatable member wall thickness is reduced for flexibility, then ease of deployment is improved, but electrical insulation performance deteriorates

Engineering Contradiction:

Improveease of deploymentVSAvoidelectrical insulation performance

Core Design Contradiction:

Ease of operationVSReliability

Solution Approach 1:

The inflatable member features localized variations in wall thickness where the middle portion has minimum thickness for flexibility and ease of deployment, while the proximal and distal portions have greater thickness for superior electrical insulation. This spatial differentiation of wall thickness allows the device to simultaneously achieve ease of deployment and reliable electrical insulation where needed.

Inventive Principle:

Principle #3Local quality

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 described solution enables selective and minimally invasive ablation of tissue with reduced damage to healthy tissue, achieving effective electroporation therapy by generating controlled electric fields.

Implementation Method 1

the first and second electrodes configured to generate an electric field for ablating tissue

Methodology Applied

Scientific EffectIrreversible electroporation: Electric Field

Implementation Method 2

the inflatable member configured to transition from an undeployed configuration to a deployed configuration

Methodology Applied

Scientific EffectElastic expansion: Elasticity

Data Source

PatentUS12318130B2Systems, apparatuses, and methods for delivery of pulsed electric field ablative energy to endocardial tissue

Publication Date: 2025.06.03 BOSTON SCIENTIFIC SCIMED INC

AI summary

Systems, devices, and methods for electroporation ablation therapy are disclosed herein, including an inflatable member for positioning an ablation device within a pulmonary vein ostium. An apparatus can include first and second shafts moveable relative to one another, first and second electrodes configured to generate an electric field for ablating tissue, and an inflatable member disposed between the first and second electrodes. In some embodiments, the inflatable member is configured to transition from an undeployed configuration to a deployed configuration in response to movement of the first and second shafts. In some embodiments, the inflatable member in the deployed configuration can engage a wall of a pulmonary vein ostium and direct the electric field generated by the first and second electrodes toward the wall.