Rolling Membrane Balloon Catheter for Stenosis Dilation
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Solution Overview
Problem
Existing rolling membrane-balloon catheters face challenges in penetrating narrow, damaged bodily vessels with minimal friction while achieving high expansion forces, as they are difficult to connect pressure-tightly to the balloon lumen and often become stuck in long, severely damaged lesions, lacking optimal flexibility and anchoring at the treatment site.
Innovation Solution
A combined rolling membrane-balloon catheter design featuring an outer and inner shaft with an intermediate shaft, a pressure-tight rolling membrane, and a dilatable balloon, where the rolling membrane can transition from a passive to an active position to minimize friction, anchor the catheter, and deliver high pressure forces effectively, with a double-membrane balloon configuration that reduces bending resistance and allows for higher pressure resistance.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Force
If the balloon is made with higher pressure resistance to achieve high expansion forces, then the balloon can deliver high dilation forces, but the balloon becomes more rigid and difficult to penetrate into narrow, damaged bodily vessels
Solution Approach 1:
The catheter system is divided into multiple functional segments: a compliant outer balloon for navigation and penetration, an inner balloon for high-pressure dilation, and a rolling membrane for friction reduction. Each segment has optimized pressure resistance characteristics, allowing the system to achieve high dilation forces without requiring the entire catheter to be rigid.
Solution Approach 2:
The patent employs a nested configuration where the inner high-pressure balloon is positioned within the outer compliant balloon, and the rolling membrane surrounds the balloon assembly. This nesting allows the inner balloon to deliver high dilation forces while the outer balloon maintains flexibility for navigation through damaged vessels.
2Ease of operation
If a rolling membrane is used to reduce friction and enable penetration into damaged vessels, then the catheter can penetrate with minimal friction, but the rolling membrane is very difficult to connect to the balloon lumen in a pressure-tight manner
Solution Approach 1:
The patent introduces an intermediate shaft as a mediator between the rolling membrane and the balloon lumen. This intermediate shaft provides a stable structural platform that facilitates reliable pressure-tight connections while allowing the rolling membrane to maintain its low-friction rolling function. The intermediate shaft acts as a transition element that reconciles the conflicting requirements of membrane mobility and connection stability.
3Ease of operation
If the catheter is made more flexible to penetrate narrow vessels, then the catheter can navigate damaged vessels, but the catheter lacks pushability and becomes stuck in long, severely damaged lesions
Solution Approach 1:
The catheter is segmented into multiple shafts with different mechanical properties. The outer shaft provides flexibility for navigation, while the inner shaft and intermediate shaft provide structural support for pushability. This segmentation allows each shaft to be optimized for its specific function without compromising the other.
Solution Approach 2:
Different parts of the catheter have different mechanical qualities tailored to their specific functions. The outer balloon and rolling membrane provide local flexibility for navigation, while the inner shaft and balloon structure provide local rigidity for pushability and force delivery at the treatment site.
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 catheter achieves low friction and high dilation forces with effective anchoring at the stenosis site, reducing bending resistance and allowing for higher pressure resistance, while maintaining pressure tightness and ease of manufacture, enhancing pushability and minimizing leakage risks.
Implementation Method 1
penetrating into a stenosis or severely damaged vessel regions with very little friction
Implementation Method 2
achieve high expansion forces, as they are difficult to connect pressure-tightly to the balloon lumen
Implementation Method 3
a dilatable balloon which can be acted on by pressurized fluid
Data Source
AI summary
A combined rolling membrane-balloon catheter, in particular for expanding stenoses in bodily vessels, including: an outer shaft (1) and an inner shaft (4) which is axially displaceable therein, an intermediate shaft (7) situated between the inner and outer shafts (4, 1) which is likewise axially displaceable, a rolling membrane (12) which is attached in a pressure-tight manner between the distal end (2) of the outer shaft (1) and the distal end (11) of the inner shaft (4), and which may be displaced between a passive position within the outer shaft (1) and an active position which is distally expanded from the outer shaft (1) by the action of pressure, and a dilatable balloon (14) which is attached in a pressure-tight manner between the distal end (11) of the inner shaft (4) and the distal end of the intermediate shaft (7), and which may be displaced between a passive position within the outer shaft (1) and proximally in front of the rolling membrane (12), and an active position which is distally expanded from the outer shaft (1), within the rolling membrane (12), by the action of pressure.