Cryogenic Balloon Ablation Catheter with Translating Diffuser

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Solution Overview

Problem

Existing cryogenic ablation techniques face challenges in delivering sufficient refrigerant to treat large lesion areas effectively, particularly in conditions like Barrett's Esophagus, where uniform refrigerant distribution is crucial for effective tissue ablation.

Innovation Solution

A cryogenic ablation catheter with an expandable and collapsible balloon, a refrigerant delivery tube assembly, and a diffuser that translates within the balloon, ensuring even refrigerant distribution across a larger area through axial movement and radial outward delivery, coupled with a handle assembly for controlled refrigerant flow and pressure management.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Quantity of substance

If a direct spray of liquid nitrogen is used for cryogenic ablation, then the ablation process can be performed, but sufficient refrigerant cannot be delivered over large lesion areas

Engineering Contradiction:
Improverefrigerant deliveryVSAvoidlesion area
Core Design Contradiction:
Quantity of substanceVSArea of stationary object

Solution Approach 1:

The balloon is made expandable and collapsible to dynamically adjust its size and shape, allowing it to conform to and cover large lesion areas. The expandable nature enables the balloon to increase its surface area for refrigerant delivery, directly addressing the limitation of delivering sufficient refrigerant over large areas.

Inventive Principle:
Principle #15Dynamics

Solution Approach 2:

The invention introduces a translational dimension by moving the refrigerant delivery tube assembly axially within the balloon. This allows the refrigerant to be delivered to different positions along the balloon's length, effectively increasing the covered area without requiring a proportionally larger balloon surface area.

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

2Manufacturing precision

If refrigerant is delivered to a larger portion of the balloon interior, then uniform ablation over larger areas is achieved, but the device complexity increases

Engineering Contradiction:
Improveuniform refrigerant distributionVSAvoiddevice complexity
Core Design Contradiction:
Manufacturing precisionVSDevice complexity

Solution Approach 1:

The diffuser assembly utilizes the balloon's internal pressure to automatically translate the refrigerant delivery tube axially. The pressure differential created during balloon expansion and collapse drives the movement, eliminating the need for external motors or complex actuation systems while achieving uniform refrigerant distribution.

Inventive Principle:
Principle #25Self-service

Solution Approach 2:

The balloon serves multiple functions: it provides the refrigerant containment chamber, acts as the delivery surface for cryogenic ablation, and generates the pressure differential that drives the translational movement of the refrigerant delivery tube. This multi-functionality reduces overall device complexity.

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

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 solution enables efficient and uniform cryogenic ablation of larger tissue areas by ensuring consistent refrigerant delivery and pressure control, enhancing the effectiveness of the treatment while minimizing damage to surrounding tissues.

Implementation Method 1

a delivery line fluidly coupled to a cryogenic gas source for supplying cryogenic gas to the refrigerant delivery tube

Methodology Applied
Scientific EffectCryogenic gas delivery: Cryogenics

Implementation Method 2

The diffuser may be configured to direct refrigerant radially outwardly towards the surface of the balloon interior

Methodology Applied
Scientific EffectRadial flow distribution:

Implementation Method 3

an expandable and collapsible balloon... During treatment, refrigerant may be delivered outwardly toward the surface of the balloon interior

Methodology Applied
Scientific EffectBalloon expansion:

Implementation Method 4

Within the catheter shaft is a pressure detecting tube extending from the connector to a position toward the distal end of the catheter shaft

Methodology Applied
Scientific EffectPressure detection:

Implementation Method 5

A linear motion assembly is connected to the plug coupler. In embodiments the linear motion assembly includes a motor and a lead screw configured for translation of the plug coupler within the housing

Methodology Applied
Scientific EffectMechanical translation:

Data Source

PatentEP3294170B1Cryogenic balloon ablation system
Publication Date: 2020.02.26 PENTAX OF AMERICA INC
  • EP3294170B1 patent drawingFigure 1
  • EP3294170B1 patent drawingFigure 2A~2C
  • EP3294170B1 patent drawingFigure 3A~4B

AI summary

A cryogenic ablation catheter (12) includes a catheter shaft (16), a balloon (24) and a connector (22) respectively at the catheter shaft proximal and distal ends (18, 20), a refrigerant delivery tube assembly including a refrigerant delivery tube (30) translatable within the catheter shaft lumen, and a refrigerant delivery element (36, 44) with an outlet (40) located inside the balloon which directs refrigerant outwardly against the balloon at different axial positions as it translates. A cryogenic balloon ablation system (10) includes the cryogenic ablation catheter, a catheter coupler (78) mating with the connector, a linear motion assembly (120), and a connection line (118) fluidly coupled to a refrigerant fluid source (100) for supplying refrigerant fluid to the refrigerant delivery tube.