Double-Walled Balloon Catheter Resists Circular Tearing
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Solution Overview
Problem
Conventional high pressure balloons used in medical procedures are prone to puncture or tearing under burst pressure, leading to complicated and longer procedures for removal, as they often tear along a circumferential path and separate into multiple pieces when bursting in a constricted state.
Innovation Solution
A dilation balloon catheter with a double-walled balloon structure and longitudinally extending rib members that form sealed cavities, allowing the layers to expand independently and resist tearing, made from non-porous elastomeric materials like Nylon or PET, with a lubricant in the cavities to enhance wall movement and maintain contact during inflation.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Force
If conventional high pressure balloons are used to exert more force and crack hard lesions, then the ability to perform high pressure procedures is improved, but the balloons are prone to puncture or tearing under burst pressure
Solution Approach 1:
The balloon is divided into multiple longitudinal segments or struts that are separated by spacers, creating a segmented structure. This segmentation allows each segment to independently withstand bursting forces without causing complete balloon failure, as the spacers distribute and contain the stress at potential failure points.
Solution Approach 2:
The balloon employs composite construction with multiple layers including an inner balloon layer, outer balloon layer, and intermediate strut-spacer assembly. This composite structure combines the flexibility of balloon material with the structural strength of struts and spacers, enabling the balloon to withstand high burst pressures while maintaining reliability.
2Strength
If high pressure balloon materials are used to increase burst strength, then the burst pressure capability is improved, but the materials are stiffer and more prone to circular tearing
Solution Approach 1:
The balloon is divided into multiple longitudinal segments or struts that are separated by spacers, creating a segmented structure. This segmentation allows each segment to independently withstand bursting forces without causing complete balloon failure, as the spacers distribute and contain the stress at potential failure points.
Solution Approach 2:
The spacers are positioned at specific locations along the balloon to provide localized reinforcement at critical stress points. This local quality enhancement prevents circular tearing by distributing stress uniformly across the balloon structure, particularly at areas most susceptible to tearing during high pressure inflation.
3Device complexity
If conventional single-layer balloons are used, then the device complexity is reduced, but the balloons separate into multiple pieces when bursting
Solution Approach 1:
The balloon is divided into multiple longitudinal segments or struts that are separated by spacers, creating a segmented structure. This segmentation allows each segment to independently withstand bursting forces without causing complete balloon failure, as the spacers distribute and contain the stress at potential failure points.
Solution Approach 2:
The balloon employs composite construction with multiple layers including an inner balloon layer, outer balloon layer, and intermediate strut-spacer assembly. This composite structure combines the flexibility of balloon material with the structural strength of struts and spacers, enabling the balloon to withstand high burst pressures while maintaining reliability.
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 significantly increases the burst pressure and resistance to circular tearing, allowing for safer and more efficient dilation procedures with reduced risk of balloon separation, thus simplifying the process and reducing procedural complexity.
Implementation Method 1
The first layer, the second layer and the rib members may each be formed from a single piece of a non-porous elastomeric material, such as Nylon (Nylon 12), polyether block amide (PEBAX), PEBAX 4033, PEBAX 5533, PEBAX 6333, and poly(ethylene terephthalate) (PET).
Data Source
AI summary
The present invention relates to medical devices for dilating or enlarging strictures or narrowed regions of body vessels. Specifically, the present invention relates to a high pressure dilation balloon catheter that includes an elongate shaft extending between a proximal end and a distal end, the proximal end being adapted for attachment to a source of inflation fluid, and a lumen extending through the shaft adapted for the passage of the inflation fluid; and a balloon disposed on the distal end of the shaft and having a balloon body extending between a proximal end and a distal end of the balloon. The balloon body includes a first layer, a second layer disposed about at least a portion of the first layer, a plurality of longitudinally extending rib members disposed between the first and the second layers and configured to form a plurality of sealed cavities between the first and the second layers; and a balloon chamber within the first layer, the balloon chamber being in a communication with the lumen of the shaft for inflating and deflating the balloon.