Medical Balloon Integral Scoring Element Manufacturing
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Solution Overview
Problem
Existing medical balloon technologies face challenges in navigating tortuous anatomy and applying focused force to tight lesions, with separate scoring wires being complex to manufacture and integral scoring elements requiring complicated processes.
Innovation Solution
A method of forming a medical balloon with integral scoring elements during the blow molding process using a mold with grooves corresponding to the scoring elements, allowing for circumferential, helical, or longitudinal projections, simplifying the manufacturing process and enhancing force application.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Force
If a separate scoring wire is attached to the balloon, then enhanced force can be provided to treat lesions, but the device becomes complicated to manufacture and the scoring wire may move circumferentially
Solution Approach 1:
The scoring element is integrated directly into the balloon structure during the extrusion process, merging the balloon and scoring element into a single component. This eliminates the need for separate scoring wires and their attachment mechanisms, thereby reducing manufacturing complexity while maintaining the force-enhancing function.
Solution Approach 2:
The scoring element is formed during the extrusion of the parison, before the balloon is inflated. This preliminary formation ensures the scoring element is permanently fixed in the desired position and orientation, preventing circumferential movement during use while simplifying the overall manufacturing process.
2Ease of manufacture
If scoring elements are formed during extrusion of a parison, then integral scoring elements can be achieved, but a complicated two-step process is required
Solution Approach 1:
The formation of scoring elements and the extrusion of the parison are merged into a single continuous operation. The mold includes integrated forming surfaces that create both the balloon structure and the scoring elements simultaneously, eliminating the need for a separate extrusion step and reducing the process to a single blow-molding operation.
3Device complexity
If the scoring force is linear according to the position of the wire or protuberance, then the structure is simple, but the effectiveness of treatment is limited
Solution Approach 1:
The scoring elements are configured to extend in multiple directions including circumferentially and helically around the balloon, transitioning from simple linear arrangements to multi-dimensional configurations. This allows the scoring force to be distributed more effectively across the lesion in various orientations, improving treatment effectiveness while maintaining structural simplicity.
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 method enables the creation of balloons with targeted scoring elements that can provide effective force distribution, improving navigation and treatment efficacy in endovascular procedures without the complexity of separate wires or extrusion processes.
Implementation Method 1
expanding a tubular parison in a mold cavity including a groove corresponding in shape to the scoring element
Implementation Method 2
applying fluid under pressure to an interior of the parison
Implementation Method 3
heating a mold section associated with the mold cavity
Data Source
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AI summary
A method of manufacturing includes forming a medical balloon (12) with a scoring element (60) along at least a barrel section by expanding a tubular parison in a mold cavity (52) including a closed end groove (52a, 52b) corresponding to the scoring element. The scoring element may extend longitudinally, circumferentially, or helically, and a plurality of scoring elements may be provided. Medical balloons formed using the method and a mold (54) for forming such balloons are also disclosed.