Cryoablation Guidewire With Integrated Pressure Sensor

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Solution Overview

Problem

Current cardiac ablation procedures, such as pulmonary vein ablation, require additional steps and equipment for verifying occlusion, including the use of contrast dye and fluoroscopy, which can be time-consuming and introduce unnecessary components into the patient.

Innovation Solution

A medical device system that integrates a treatment element, such as a cryoballoon, with a sensing component featuring a pressure sensor and mapping elements, allowing for real-time position assessment and occlusion verification based on blood pressure measurements, thereby simplifying the procedure and reducing the need for additional equipment and chemicals.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Measurement precision

If contrast dye and fluoroscopy are used to verify occlusion, then occlusion verification accuracy is improved, but procedural time and device complexity increase

Engineering Contradiction:

Improveocclusion verification accuracyVSAvoidprocedural time

Core Design Contradiction:

Measurement precisionVSLoss of time

Solution Approach 1:

The patent replaces the mechanical/chemical system of contrast dye injection and fluoroscopic imaging with a pressure sensing system. Pressure sensors mounted on the distal portion of the ablation balloon directly measure pressure changes in the pulmonary vein to determine occlusion status, eliminating the need for contrast dye and fluoroscopy and thereby reducing procedural time while maintaining verification accuracy

Inventive Principle:

Principle #28Mechanics substitution (Replace mechanical system)

Solution Approach 2:

The patent introduces pressure sensors as an intermediary measurement tool between the ablation balloon and the pulmonary vein. These sensors detect pressure changes caused by occlusion without requiring contrast dye or external imaging equipment, providing real-time feedback that reduces procedural time while maintaining measurement precision

Inventive Principle:

Principle #24Intermediary (Mediator)

2Measurement precision

If contrast dye is injected to assess vein occlusion, then occlusion verification is improved, but the quantity of substances introduced into the patient increases

Engineering Contradiction:

Improveocclusion verification accuracyVSAvoidcontrast dye volume

Core Design Contradiction:

Measurement precisionVSQuantity of substance

Solution Approach 1:

The patent replaces the chemical method of contrast dye injection with a mechanical pressure sensing system. Pressure sensors directly measure pressure changes in the pulmonary vein to determine occlusion status, eliminating the need to introduce contrast dye into the patient's vasculature while maintaining accurate occlusion verification

Inventive Principle:

Principle #28Mechanics substitution (Replace mechanical system)

3Measurement precision

If fluoroscopy is used for real-time visualization, then positioning accuracy is improved, but device complexity and equipment requirements increase

Engineering Contradiction:

Improvepositioning accuracyVSAvoidequipment requirements

Core Design Contradiction:

Measurement precisionVSDevice complexity

Solution Approach 1:

The patent replaces the complex fluoroscopy imaging system with a simple pressure sensing system integrated into the ablation balloon. Pressure sensors provide real-time feedback on occlusion status and positioning through pressure measurements, eliminating the need for fluoroscopy equipment while maintaining positioning accuracy through direct physiological measurement

Inventive Principle:

Principle #28Mechanics substitution (Replace mechanical system)

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 real-time physiological data collection and precise positioning of the treatment element, enhancing the efficiency and safety of cardiac ablation procedures by eliminating the need for contrast dye and reducing procedural time.

Implementation Method 1

a pressure sensor, the pressure sensor transmitting blood pressure measurements to the processor

Methodology Applied

Scientific EffectPressure sensing:

Data Source

PatentUS10159521B2Diagnostic guidewire for cryoablation sensing and pressure monitoring

Publication Date: 2018.12.25 MEDTRONIC CRYOCATH LP

AI summary

A method and system for performing pulmonary vein isolation, mapping, and assessing pulmonary vein occlusion using a single device. The device may generally include an ablation element, such as a cryoballoon, and a sensing component slidably disposed within a lumen of the device and bearing one or more mapping electrodes and one or more pressure sensors. The method may generally include mapping cardiac electrical signals within a heart and/or pulmonary vein, positioning a distal portion of the sensing component within a pulmonary vein, advancing the ablation element until it is in contact with the pulmonary vein ostium, recording blood pressure measurements within the pulmonary vein with the one or more pressure sensors to assess pulmonary vein occlusion, and activating the treatment element when the pulmonary vein is completely occluded. The sensing component may have a straight or hooped configuration, or a configuration therebetween.