Cryoablation Catheter Tip Shape Transition Mechanism

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Solution Overview

Problem

Current cryogenic ablation devices lack pre-fabricated ablation elements with precise geometric configurations, leading to imprecise lesion formation, increased procedure time, and requiring skilled surgeons to modify the device during procedures.

Innovation Solution

A medical device with a thermally insulative sheath and a fluid injection tube that passively transitions between geometric configurations, allowing for pre-fabricated shapes and minimizing the need for surgeon skill, including a cryogenic ablation element that changes from linear to circular or curvilinear configurations as the sheath is retracted.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Adaptability or versatility

If current cryogenic ablation devices use fixed ablation elements (distal tip or balloon), then the device structure is simple, but the device cannot adapt to different lesion types and locations

Engineering Contradiction:

Improveability to create different lesion shapesVSAvoiddevice structure

Core Design Contradiction:

Adaptability or versatilityVSDevice complexity

Solution Approach 1:

The ablation element transitions from a static fixed configuration to a dynamic reconfigurable structure. The catheter can transform between a linear configuration (for focal lesions) and an expanded circular configuration (for circumferential lesions) during the procedure, allowing adaptation to different lesion types without requiring multiple separate devices.

Inventive Principle:

Principle #15Dynamics

Solution Approach 2:

The ablation element is divided into multiple segments or struts that can be independently positioned. These segments can be collapsed into a linear configuration for delivery and then expanded into a circular configuration at the target site, enabling the device to create different lesion shapes by deploying different segments in different spatial arrangements.

Inventive Principle:

Principle #1Segmentation

2Manufacturing precision

If surgeons modify the treatment end of the ablation device during procedures to create desired lesion shapes, then the device can be customized for the specific lesion, but the procedure time increases and requires high surgeon skill

Engineering Contradiction:

Improvelesion shape accuracyVSAvoidprocedure time

Core Design Contradiction:

Manufacturing precisionVSLoss of time

Solution Approach 1:

The ablation element is pre-configured with multiple possible geometric arrangements (linear, circular, etc.) during manufacturing. During the procedure, the surgeon simply selects the appropriate pre-configured shape by actuating the deployment mechanism, eliminating the need to modify the device structure during the procedure and reducing both time and skill requirements.

Inventive Principle:

Principle #10Preliminary action

Solution Approach 2:

The device includes an automated deployment mechanism that transforms the ablation element from a delivery configuration to a treatment configuration. The surgeon controls this transformation through simple actuation, and the device automatically assumes the desired geometric shape without requiring manual manipulation or modification by the surgeon.

Inventive Principle:

Principle #25Self-service

3Ease of operation

If pull wires are used to deflect the distal end of the ablation device to modify its shape, then the device can be shaped during the procedure, but the shape control is imprecise and requires surgeon skill

Engineering Contradiction:

Improvedevice shapingVSAvoidshape control precision

Core Design Contradiction:

Ease of operationVSMeasurement precision

Solution Approach 1:

The manual mechanical manipulation using pull wires is replaced with a more precise deployment mechanism. This new mechanism uses controlled actuation (such as balloons, shape memory alloys, or motorized systems) to transform the ablation element into precise geometric configurations, providing better shape control and reducing dependence on surgeon skill.

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 precise lesion formation with reduced procedure time and minimal skill requirement, as the device automatically adjusts to desired shapes and sizes based on the sheath's retraction, improving the accuracy and efficiency of cardiac tissue ablation.

Implementation Method 1

A thermally insulative sheath is included disposed within the ablation element

Methodology Applied

Scientific EffectThermal insulation: Thermal Insulation

Implementation Method 2

Current cryogenic ablation devices create lesions by transfer of heat from the target tissue to either a balloon filled with cryogenic fluid

Methodology Applied

Scientific EffectHeat transfer: Conduction (thermal)

Implementation Method 3

cryogenic freezing... cool the tissue to a level at which freezing destroys the viability of the tissue

Methodology Applied

Scientific EffectCryogenic freezing: Freezing

Data Source

PatentEP2806815B1Large area cryoablation catheter with multi-geometry tip ecg/cryo mapping capabilities

Publication Date: 2017.03.01 MEDTRONIC CRYOCATH LP

AI summary

A medical device including an ablation element. A thermally insulative sheath is included disposed within the ablation element. A fluid injection tube is disposed within a portion of the thermally insulative sheath. The ablation element passively transitions from a substantially linear geometric configuration to a substantially circular geometric configuration as the sheath is retracted proximally from a first position in which the sheath substantially encloses the fluid injection tube to a second position in which a portion of the fluid injection tube extends a distance away from the sheath.