Cryoballoon Fluid Injection Line Compensation Assembly

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Solution Overview

Problem

Conventional fluid injection lines in cryoballoon ablation procedures can cause unwanted forces that distort the guidewire lumen, leading to non-uniform cryogenic fluid distribution and potential complications due to biasing forces during extension and retraction, compromising procedural outcomes.

Innovation Solution

A fluid injection line compensation assembly that includes a movable fluid discharge region and frictional elements, such as O-rings or electronic actuators, to maintain the fluid injection line's position relative to the guidewire lumen, ensuring uniform fluid distribution and minimizing biasing forces during the ablation procedure.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Stability of the object's composition

If the fluid injection line is affixed to the guidewire lumen, then the fluid injection line maintains position during extension and retraction, but unwanted forces distort the guidewire lumen and compromise fluid distribution uniformity

Engineering Contradiction:
Improveposition stability of fluid injection lineVSAvoiduniformity of cryogenic fluid distribution
Core Design Contradiction:
Stability of the object's compositionVSEase of operation

Solution Approach 1:

The fluid injection line is divided into distinct segments: a proximal portion, a distal portion, and a intermediate portion with frictional engagement. This segmentation allows different sections to perform different functions - the proximal and distal portions maintain positioning while the intermediate portion provides controlled frictional engagement without distorting the guidewire lumen

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

Frictional engagement features (such as O-rings or textured surfaces) are applied locally at specific positions along the fluid injection line rather than along its entire length. This localized frictional engagement provides sufficient positioning stability while minimizing the total contact area and unwanted forces on the guidewire lumen

Inventive Principle:
Principle #3Local quality

2Adaptability or versatility

If the guidewire lumen is made movable for extension and retraction, then the catheter can be deployed and retrieved, but biasing forces are generated that distort fluid distribution

Engineering Contradiction:
Improveextension and retraction capabilityVSAvoiduniformity of fluid distribution
Core Design Contradiction:
Adaptability or versatilityVSEase of operation

Solution Approach 1:

The frictional engagement features act as intermediaries between the fluid injection line and the guidewire lumen. These features provide controlled resistance that allows the guidewire lumen to move during extension and retraction while maintaining sufficient friction to prevent excessive distortion and ensure uniform fluid distribution

Inventive Principle:
Principle #24Intermediary (Mediator)

Solution Approach 2:

The frictional engagement is designed to be dynamic rather than rigid - it provides sufficient friction to maintain positioning and uniform fluid distribution, but allows controlled movement during deployment and retrieval. This dynamic characteristic enables the system to adapt to different operational states

Inventive Principle:
Principle #15Dynamics

3Stability of the object's composition

If frictional elements are added to maintain fluid injection line position, then positioning stability improves, but device complexity increases

Engineering Contradiction:
Improveposition stability of fluid injection lineVSAvoidcomplexity of compensation assembly
Core Design Contradiction:
Stability of the object's compositionVSDevice complexity

Solution Approach 1:

The frictional engagement features utilize the natural friction between the fluid injection line and the guidewire lumen, or between the O-rings and the guidewire lumen, to provide positioning stability. This self-service mechanism eliminates the need for additional active control systems, motors, or complex mechanical assemblies to maintain position

Inventive Principle:
Principle #25Self-service

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 compensation assembly allows for precise control of the fluid injection line's movement with the guidewire lumen, reducing the risk of collateral tissue damage and improving the uniformity of cryogenic fluid distribution within the cryoballoon, thereby enhancing the efficacy of the cryoablation procedure.

Implementation Method 1

the proximal region is configured to form a compression spring that biases the distal region in a direction away from the proximal region

Methodology Applied
Scientific EffectElasticity: Elasticity

Implementation Method 2

a frictional element that frictionally maintains the positioning of the fluid injection line

Methodology Applied
Scientific EffectFriction: Friction

Data Source

PatentUS11419657B2Compensation assembly for fluid injection line of intravascular catheter system
Publication Date: 2022.08.23 BOSTON SCIENTIFIC SCIMED INC
  • US11419657B2 patent drawing
  • US11419657B2 patent drawing
  • US11419657B2 patent drawing

AI summary

A fluid injection line compensation assembly for an intravascular catheter system including a balloon catheter having a guidewire lumen and a cryoballoon, includes a fluid injection line, a proximal fluid injection line stop, and a distal fluid injection line stop. The fluid injection line has a fluid discharge region positioned within the cryoballoon. The fluid discharge region includes a fluid port so that cryogenic fluid can be distributed from the fluid injection line to within the cryoballoon. The fluid discharge region is not affixed to the guidewire lumen. The proximal fluid injection line stop is positioned adjacent to the guidewire lumen, the proximal fluid injection line stop being positioned within the cryoballoon. The distal fluid injection line stop is positioned adjacent to the guidewire lumen so that the fluid discharge region is positioned between the proximal fluid injection line stop and the distal fluid injection line stop.