Cutting Balloon Catheter Delamination Prevention

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Solution Overview

Problem

Angioplasty cutting balloon blades often experience delamination due to stress during procedures, which can lead to ineffective treatment and complications.

Innovation Solution

The design incorporates an expandable member with a cutting member and a covering that is fixedly attached to both the expandable member and the cutting member, using a thermoplastic polyurethane coating and fiber reinforcement to prevent delamination, and includes a mounting pad and attachment material to secure the cutting member in place.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If cutting elements are mounted on the angioplasty balloon to enhance treatment effectiveness, then the ability to reduce re-stenosis is improved, but the structural integrity deteriorates due to delamination under stress

Engineering Contradiction:
Improvetreatment effectivenessVSAvoidstructural integrity
Core Design Contradiction:
ReliabilityVSStability of the object's composition

Solution Approach 1:

The patent employs a composite structure consisting of multiple layers: a balloon cuff layer, a mounting pad layer with cutting elements, and a reinforcing fiber layer. These composite materials work together to provide both the cutting function and structural integrity, preventing delamination while maintaining treatment effectiveness.

Inventive Principle:
Principle #40Composite materials

Solution Approach 2:

The cutting element assembly is segmented into distinct functional components: the balloon cuff, the mounting pad, the cutting edges, and the reinforcing fibers. This segmentation allows each component to perform its specific function while maintaining overall structural integrity through proper interface design.

Inventive Principle:
Principle #1Segmentation

2Productivity

If cutting elements are attached to the balloon surface, then cutting capability is enhanced, but the risk of delamination increases under procedural stress

Engineering Contradiction:
Improvecutting capabilityVSAvoiddelamination resistance
Core Design Contradiction:
ProductivityVSReliability

Solution Approach 1:

The mounting pad serves as an intermediary layer between the balloon cuff and the cutting elements. This intermediate structure distributes mechanical stresses and provides a stable base for the cutting edges, reducing the risk of delamination while maintaining cutting capability.

Inventive Principle:
Principle #24Intermediary (Mediator)

Solution Approach 2:

The reinforcing fibers are preliminarily integrated into the mounting pad structure before the cutting elements are attached. This preliminary reinforcement prevents delamination from occurring in the first place during procedural stress, ensuring reliable cutting capability.

Inventive Principle:
Principle #10Preliminary action

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

This configuration enhances the structural integrity of the cutting balloon, reducing the likelihood of delamination and ensuring effective engagement with the target site during angioplasty procedures.

Implementation Method 1

a covering that is fixedly attached to both the expandable member and the cutting member

Methodology Applied
Scientific EffectAdhesion: Adhesive

Data Source

PatentUS11812987B2Cutting balloon catheter
Publication Date: 2023.11.14 BOSTON SCIENTIFIC SCIMED INC
  • US11812987B2 patent drawing
  • US11812987B2 patent drawing
  • US11812987B2 patent drawing

AI summary

An example cutting balloon is disclosed. The example cutting balloon includes an expandable member having an outer surface and longitudinal axis, a first cutting member disposed along the outer surface of the expandable member and a covering encapsulating the expandable member and the first cutting member.