Rotatable Cryogenic Balloon Ablation Catheter for Lesion Targeting

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Solution Overview

Problem

Accurately positioning treatment devices within the GI tract to target focal lesions such as intestinal metaplasia and dysplasia or 'flat' polyps remains a challenge due to limitations in existing technologies for precise lesion targeting.

Innovation Solution

A cryogenic ablation catheter with an expandable and collapsible balloon and a refrigerant delivery tube assembly, where the refrigerant delivery tube is housed within the catheter shaft for rotary movement, allowing refrigerant to be directed radially outwardly towards the balloon's inner surface for precise cryogenic ablation, combined with a handle assembly for cryogenic gas supply and pressure sensing, facilitating improved lesion targeting.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Measurement precision

If a stationary refrigerant delivery system is used in the balloon catheter, then the device structure is simple, but the ability to accurately target and treat specific lesions is limited

Engineering Contradiction:
Improvelesion targeting precisionVSAvoiddevice structure complexity
Core Design Contradiction:
Measurement precisionVSDevice complexity

Solution Approach 1:

The refrigerant delivery tube is made rotatable within the catheter shaft, allowing dynamic repositioning of the refrigerant outlet to target different locations on the balloon surface. This rotational capability enables precise lesion targeting while maintaining a relatively simple overall device structure.

Inventive Principle:
Principle #15Dynamics

Solution Approach 2:

The invention adds rotational freedom to the refrigerant delivery tube, transitioning from a fixed one-dimensional delivery path to a multi-dimensional delivery system. This allows the refrigerant outlet to be oriented in multiple directions, enabling accurate targeting of lesions at different positions on the balloon surface.

Inventive Principle:
Principle #17Another dimension (Dimensionality change)

2Reliability

If refrigerant is delivered uniformly across the balloon surface, then the delivery system is simple, but the effectiveness of treating specific focal lesions is reduced

Engineering Contradiction:
Improvetreatment effectivenessVSAvoidrefrigerant delivery control
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The rotatable refrigerant delivery tube allows concentrated refrigerant delivery to specific localized areas of the balloon surface corresponding to target lesions. This enables differentiated treatment zones where refrigerant can be precisely directed to affected areas while sparing healthy tissue.

Inventive Principle:
Principle #3Local quality

Solution Approach 2:

The ability to rotate the refrigerant delivery tube dynamically allows the system to adapt refrigerant delivery to the specific location and orientation of lesions, enhancing treatment effectiveness for focal targets rather than uniform application.

Inventive Principle:
Principle #15Dynamics

3Adaptability or versatility

If the refrigerant delivery tube is fixed relative to the catheter shaft, then the device is easier to manufacture, but the flexibility to adjust treatment orientation is limited

Engineering Contradiction:
Improvetreatment orientation adjustmentVSAvoiddevice manufacturing
Core Design Contradiction:
Adaptability or versatilityVSEase of manufacture

Solution Approach 1:

The rotatable connection between the refrigerant delivery tube and catheter shaft provides adjustable orientation capability. This allows the tube to be rotated to different angles and positions to match the orientation of lesions, enhancing treatment adaptability while maintaining manufacturability through standardized rotational joints.

Inventive Principle:
Principle #15Dynamics

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

Enhances the precision and effectiveness of cryogenic ablation by allowing for controlled refrigerant delivery and pressure management, improving the ability to accurately target and treat lesions within the GI tract.

Implementation Method 1

The refrigerant delivery tube is housed within the catheter shaft for rotary movement relative to the catheter shaft

Methodology Applied
Scientific EffectRotational movement:

Implementation Method 2

the balloon can press against and cool esophageal target tissue

Methodology Applied
Scientific EffectThermal conduction: Conduction (thermal)

Implementation Method 3

Ablation assembly also includes a pressure sensing system

Methodology Applied
Scientific EffectPressure sensing:

Data Source

PatentEP3062720B1Cryogenic balloon ablation system
Publication Date: 2021.04.07 PENTAX OF AMERICA INC
  • EP3062720B1 patent drawingFigure 1
  • EP3062720B1 patent drawingFigure 2
  • EP3062720B1 patent drawingFigure 3

AI summary

A cryogenic ablation catheter 12 includes a catheter shaft 16, a balloon 24 and a connector 30 respectively at the catheter shaft proximal and distal ends 18, 20, a refrigerant delivery tube assembly including a refrigerant delivery tube 34 rotatable within the catheter shaft lumen 22, and a refrigerant delivery element 40 with an outlet 42 located inside the balloon which directs refrigerant 44 outwardly against the balloon at different rotary positions as it rotates. A cryogenic balloon ablation system 10 includes the cryogenic ablation catheter, a catheter coupler 119 mating with the connector, a motor 104 including a rotatable hollow motor shaft 102, and a delivery line 100 fluidly coupled to a cryogenic gas source 84 for supplying cryogenic gas to the refrigerant delivery tube. At least one of the refrigerant delivery tube and the delivery line passes at least partway through the hollow motor shaft. The coupling tip 60 of the connector and the refrigerant delivery tube 34 rotate with the motor shaft 102.