Scoring Balloon Catheter With Translating Wires for Tight Lesions

Solution Overview

Problem

Balloon dilatation catheters face challenges in navigating tortuous anatomy and safely crossing tight lesions, and existing systems provide limited focused force and maneuverability for effective lesion dilation.

Innovation Solution

A scoring balloon catheter with an inflatable balloon and scoring wires, featuring a shaft, a spring or resilient member, and scoring wire lumens, which allows for focused force application and improved maneuverability by using movable scoring wire ends and a hub assembly to manage tension and movement during inflation and deflation.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Force

If a balloon is used for lesion dilation, then the lesion can be dilated, but the balloon cannot provide sufficient focused force and maneuverability to safely cross tight lesions and navigate tortuous anatomy

Engineering Contradiction:

Improvefocused forceVSAvoidmaneuverability

Core Design Contradiction:

ForceVSEase of operation

Solution Approach 1:

The scoring wire is divided into multiple segments: a fixed end mounted on the shaft, an intermediate portion disposed outside the balloon, and a movable end associated with the spring. This segmentation allows the wire to provide focused force at the lesion while the movable end can translate to accommodate balloon inflation/deflation, maintaining maneuverability.

Inventive Principle:

Principle #1Segmentation

Solution Approach 2:

The scoring wire system incorporates dynamic elements including a movable end that translates with balloon inflation and deflation, and a spring that dynamically adjusts the wire's position and force application. This dynamic design enables the wire to maintain effectiveness during the dilation process while allowing the balloon to maneuver freely.

Inventive Principle:

Principle #15Dynamics

2Force

If a scoring wire is fixed to the shaft, then focused force can be applied to the lesion, but the balloon loses pushability and maneuverability due to wire tension

Engineering Contradiction:

Improvefocused forceVSAvoidpushability

Core Design Contradiction:

ForceVSEase of operation

Solution Approach 1:

The scoring wire's movable end is associated with a spring that allows it to translate in response to balloon inflation and deflation. This dynamic connection enables the wire to maintain tension for focused force application while simultaneously allowing the balloon to be pushed and maneuvered without being constrained by a rigid fixed connection.

Inventive Principle:

Principle #15Dynamics

Solution Approach 2:

The spring acts as an intermediary element between the fixed scoring wire and the movable balloon. It transmits force from the wire to the balloon while allowing relative movement, thus maintaining both focused force application and balloon pushability/maneuverability.

Inventive Principle:

Principle #24Intermediary (Mediator)

3Force

If the scoring wire is made rigid to provide focused force, then lesion dilation is effective, but the wire cannot accommodate balloon inflation and deflation cycles

Engineering Contradiction:

Improvefocused forceVSAvoidaccommodation of inflation/deflation

Core Design Contradiction:

ForceVSAdaptability or versatility

Solution Approach 1:

The scoring wire system incorporates dynamic elements including a movable end that translates with balloon inflation and deflation, and a spring that dynamically adjusts the wire's position and force application. This dynamic design enables the wire to maintain effectiveness during the dilation process while allowing the balloon to maneuver freely.

Inventive Principle:

Principle #15Dynamics

Solution Approach 2:

The scoring wire is divided into multiple segments: a fixed end mounted on the shaft, an intermediate portion disposed outside the balloon, and a movable end associated with the spring. This segmentation allows the wire to provide focused force at the lesion while the movable end can translate to accommodate balloon inflation/deflation, maintaining maneuverability.

Inventive Principle:

Principle #1Segmentation

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 ability to safely and effectively dilate lesions by providing focused force and improved pushability and maneuverability, reducing strain on the balloon and maintaining predictable inflation and deflation cycles.

Implementation Method 1

the member comprises or interacts with a longitudinally resilient member such as an elastic polymer or rubber or a spring

Methodology Applied

Scientific EffectElasticity: Elasticity

Data Source

PatentUS12458392B2Scoring balloon with translating scoring wires

Publication Date: 2025.11.04 CR BARD INC

AI summary

A device for introduction into a body vessel includes a shaft, a balloon positioned at the distal end of the shaft, a guidewire disposed longitudinally within the shaft to receive a guidewire during use, a balloon disposed at the distal end of the shaft, and longitudinal scoring wires to score a vascular lesion attached to the distal end of the shaft, disposed over the balloon and disposed within the shaft. The proximal ends are welded or otherwise affixed to a spring mounted in the handle. The balloon expands when fluid is delivered to the balloon through the inflation lumen. This expansion pushes the scoring wires against the vascular lesion.