Apertured Multilayer Balloon Catheter for Flow-Preserving Debris Capture
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Solution Overview
Problem
Existing balloon catheters disrupt blood flow during inflation, leading to complications such as tissue ischemia or necrosis, and are ineffective in capturing debris and blood clots, particularly during vascular procedures.
Innovation Solution
An apertured balloon catheter with multiple layers and tethered orifices that allow fluid flow, enabling inflation without compromising blood flow and capturing debris, designed for use in vascular and non-vascular applications.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If traditional balloon catheters are inflated to perform therapeutic interventions, then the balloon can dilate blockages and perform procedures, but blood flow is interrupted and tissue ischemia or necrosis may occur
Solution Approach 1:
The balloon is divided into multiple layers (first balloon layer, second balloon layer, third balloon layer) with distinct functions. The first and second layers form a first space for inflation, while the third layer forms a second space with apertures for blood flow. This segmentation allows the balloon to maintain structural integrity for therapy while preserving blood flow pathways.
Solution Approach 2:
Different regions of the balloon have different properties: the first space is sealed for inflation pressure, while the second space contains apertures that allow blood flow. The tethers are strategically positioned to connect layers at specific locations, creating localized flow paths while maintaining overall balloon structure for therapeutic contact.
2Reliability
If traditional balloon catheters are used for angioplasty and valvuloplasty, then vessel dilation can be achieved, but debris and blood clots are not captured
Solution Approach 1:
The patent extracts the debris capture function from the traditional balloon structure by incorporating a separate collection space (second space) with apertures that allow debris and clots to enter and be trapped within the balloon structure, separating this function from the inflation and dilation function.
Solution Approach 2:
The balloon structure is designed to perform multiple functions simultaneously: the first space provides inflation for vessel dilation, while the second space with apertures captures debris and clots. This multi-functionality addresses both vessel opening and debris removal in a single device.
3Object-affected harmful factors
If multiple layers are added to the balloon to enable fluid flow and debris capture, then blood flow can be maintained and debris captured, but the device complexity increases
Solution Approach 1:
The patent merges the inflation function and debris capture function into a single integrated balloon structure. The first and second spaces are formed within the same balloon assembly, sharing common tethers and structural elements, which reduces overall device complexity compared to having separate devices for each function.
Solution Approach 2:
The second space (debris collection space) is nested within the structure formed by the first and second balloon layers. The tethers are positioned at specific locations to create both spaces efficiently, with the third layer forming the second space that is contained within the overall balloon structure.
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
Maintains blood flow while performing therapeutic interventions like angioplasty and capturing debris, reducing complications and enhancing procedural safety.
Implementation Method 1
Each tether has an orifice for passing of a body fluid from outside of the apertured balloon catheter to inside of the apertured balloon catheter and from inside of the apertured balloon catheter to outside of the apertured balloon catheter
Implementation Method 2
A first conduit extends within the balloon and is in fluid communication with the first space for selectively filling the first space with a fluid
Implementation Method 3
A balloon is coupled to the internal conduit and the balloon has layers that include an inner balloon layer and an outer balloon layer forming therein a first space therebetween
Data Source
AI summary
An apertured balloon catheter consisting of 3 segments: a proximal segment, a central segment and a distal segment. The proximal and distal segments have two layers, and the central segment has three layers. Each layer of the proximal, distal segment, and first two layers of the central segment are tethered at several points forming a space therebetween, which is selectively filled with a fluid by a conduit to expand the apertured balloon catheter. The third layer of the central segment forms a second space with the second central layer and is selectively filled by a separate conduit to expand against the vessel wall. The proximal balloon segment and the distal balloon segment have apertures within the tether points that communicate with the lumen of the blood vessel within the inflated balloon chamber. The size of the apertures is set to capture blood debris flowing through the apertured balloon catheter.