Medical Balloon Polymer Sleeve Braid End Security
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Solution Overview
Problem
Medical balloons used in procedures like angioplasty often face challenges in navigating tortuous and narrow pathways, and achieving high pressure expansion requires reinforcing materials like fiber braids, but existing methods may not adequately secure the braid ends, potentially interfering with device functionality.
Innovation Solution
A catheter assembly with a balloon and fiber braid where a polymer sleeve is thermally bonded to the balloon waist and catheter shaft, extending into the braid to secure and seal the braid ends, ensuring a fluid-tight bond and maintaining structural integrity under high pressures.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Strength
If a fiber braid is added to increase radial strength for high pressure expansion, then the balloon can achieve high pressure expansion, but the braid ends may not be adequately secured and may interfere with device functionality
Solution Approach 1:
A polymer sleeve is introduced as an intermediary component between the fiber braid and the balloon body. The sleeve extends along the balloon surface and over the braid ends, securing them in place. This intermediary structure prevents the braid ends from interfering with device functionality while maintaining the radial strength enhancement provided by the braid.
Solution Approach 2:
The polymer sleeve is positioned such that it extends over the fiber braid ends, creating a nested configuration where the sleeve contains and secures the braid terminations. This nesting arrangement ensures the braid ends are properly contained without compromising the overall structural integrity or functionality of the balloon device.
2Reliability
If a polymer sleeve is added to secure the braid ends, then the braid ends are secured and sealed, but the device complexity increases
Solution Approach 1:
The polymer sleeve serves multiple functions simultaneously: it secures the fiber braid ends in place, provides a fluid-tight seal around the braid terminations, and integrates with the existing balloon structure. By combining these functions into a single component, the design achieves reliable braid end security without proportionally increasing device complexity.
3Reliability
If the polymer sleeve is thermally bonded to the balloon and catheter shaft, then a fluid-tight bond is achieved, but the manufacturing process complexity increases
Solution Approach 1:
Thermal bonding is used to replace mechanical bonding methods (such as adhesives or mechanical fasteners) for attaching the polymer sleeve to the balloon and catheter shaft. This substitution provides a more reliable fluid-tight bond through fusion of materials, though it requires thermal processing equipment. The thermal bonding process integrates well with existing balloon manufacturing processes.
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 solution provides a secure and reliable high-pressure medical balloon system that effectively navigates complex pathways and maintains structural integrity, preventing braid end interference with medical devices and ensuring consistent blood flow restoration.
Implementation Method 1
a polymer sleeve disposed on the catheter shaft, wherein the polymer sleeve abuts the proximal end of the balloon waist and the proximal end of the braid
Implementation Method 2
the polymer of the balloon waist has a melting point that is greater than the melting point of the polymer of the polymer sleeve
Data Source
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AI summary
Catheter assemblies and methods for making and using catheter assemblies are disclosed. An example a catheter assembly includes a catheter shaft and a balloon attached to the catheter shaft. The balloon includes a body and a proximal waist portion. The proximal waist portion has a proximal end. The catheter assembly also has a fiber braid including one or more individual filaments disposed along the balloon. The fiber braid has a proximal end aligned with the proximal end of the waist portion. The catheter assembly also has a polymer sleeve disposed on the catheter shaft, wherein in the polymer sleeve abuts the proximal end of the balloon waist and the proximal end of the braid.