Scoring Balloon Tapered Elements Vessel Snagging

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Solution Overview

Problem

Existing cutting or scoring balloons face challenges in maintaining flexibility during introduction into the vasculature while protecting healthy vessel tissue from cutting elements, and require reliable and efficient manufacturing processes.

Innovation Solution

A scoring balloon design featuring a balloon body with proximal and distal end cone portions, where scoring elements extend across the entire structure, decreasing in height along the taper of the cone portions to prevent snagging and maintain flexibility, and are preferably integral and co-extruded with the balloon material.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Object-affected harmful factors

If scoring elements extend across the entire balloon including end portions, then healthy vessel tissue is protected from sharp edges, but balloon flexibility is reduced

Engineering Contradiction:
Improvesharp edges damaging healthy vessel tissueVSAvoidballoon flexibility during introduction
Core Design Contradiction:
Object-affected harmful factorsVSEase of operation

Solution Approach 1:

The scoring elements are designed with varying heights along the balloon length, with reduced height at the end portions compared to the body portion. This local variation in geometry allows the scoring elements to provide protection where needed while maintaining flexibility at the balloon ends during introduction into the vasculature.

Inventive Principle:
Principle #3Local quality

Solution Approach 2:

The height parameter of the scoring elements is changed along the length of the balloon, creating a gradient from the body portion to the end portions. This parameter variation resolves the contradiction by providing sharp edges for protection in the body portion while reducing stiffness at the ends to maintain flexibility.

Inventive Principle:
Principle #35Parameter changes

2Ease of manufacture

If scoring elements have uniform height across the entire balloon, then manufacturing is simplified, but flexibility at end portions is reduced

Engineering Contradiction:
Improvescoring element consistencyVSAvoidballoon flexibility at end portions
Core Design Contradiction:
Ease of manufactureVSEase of operation

Solution Approach 1:

The scoring elements exhibit local quality variations in height along the balloon length, with uniform height in the body portion for manufacturing simplicity and reduced height at end portions for flexibility. This localized differentiation resolves the contradiction between manufacturing ease and operational flexibility.

Inventive Principle:
Principle #3Local quality

3Area of stationary object

If scoring elements extend along the entire balloon length, then complete coverage is achieved, but manufacturing complexity increases

Engineering Contradiction:
Improvescoring element coverage areaVSAvoidmanufacturing process complexity
Core Design Contradiction:
Area of stationary objectVSDevice complexity

Solution Approach 1:

The scoring elements are formed with continuous parameter changes in height along the balloon length, extending from the body portion to the end portions. This continuous geometric variation achieves complete coverage while simplifying manufacturing by eliminating the need for separate scoring element components or complex assembly processes.

Inventive Principle:
Principle #35Parameter changes

Data Source

PatentEP2642932B1Scoring balloon and method of making same
Publication Date: 2014.03.19 COOK MEDICAL TECHNOLOGIES LLC
  • EP2642932B1 patent drawingFigure 1~3
  • EP2642932B1 patent drawingFigure 4a~4b

AI summary

A scoring balloon (10) includes a generally cylindrical and straight body portion (12) and both ends of the body portion (12) end cone portions (14, 16). At both extremities of the end cone portions (14, 16) there are neck portions (18,20) which are fixed to a catheter or carrier element (22). A plurality of scoring elements (24) extend from one end of the balloon (10) to the other. Each scoring element (24) has a central uniform section (26) which extends along the body portion (12) of the balloon and tapering sections (28,30) which extend from the central section (26) and along the balloon end cones (14, 16). The tapering sections (28,30) taper from a height generally consistent with the central section (26) to a lower height along the direction of taper of the balloon end cones (18,20). This reduction in height of the scoring elements (24) as the balloon narrows enhances the flexibility of the balloon at the cone portions (18,20) and also ensures that there is no abrupt change in the height of the scoring elements (24) which could present a shoulder or other edge able to snag on a vessel wall or medical device located in a patient's lumen.