Multi-stage balloon catheter for incremental lumen dilation
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Solution Overview
Problem
Current balloon catheter systems lack the capability to incrementally expand to multiple stages, which is necessary for minimizing tissue trauma during medical procedures, as they often require discrete balloon diameters and pressures to effectively widen passageways in body lumens such as the esophagus, blood vessels, or airways.
Innovation Solution
A multi-stage balloon catheter system comprising a balloon catheter assembly with a polymeric catheter body and inflation balloon, configured to be expanded to various stages with discrete diameters and pressures, supported by a fixed wire for rigidity and featuring a balloon inflation device with a pressure gauge for precise control, allowing incremental expansion to treat strictures effectively.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Adaptability or versatility
If a single-balloon catheter system is used, then the device structure is simple, but it cannot achieve incremental expansion to multiple stages
Solution Approach 1:
The single balloon is divided into multiple expandable sections or stages along its length, allowing incremental expansion from proximal to distal segments. Each segment can be inflated independently at different pressures and diameters, enabling multi-stage dilation while using a single continuous balloon structure rather than multiple separate balloons.
Solution Approach 2:
The catheter system incorporates dynamic control mechanisms that allow the balloon to transition between deflated and inflated states at multiple stages. The system enables progressive expansion through controlled fluid injection and pressure regulation, allowing the balloon to adapt its configuration dynamically during the procedure rather than requiring discrete pre-configured balloon sizes.
2Object-affected harmful factors
If discrete balloon diameters and pressures are used, then the device is easier to manufacture, but it cannot minimize tissue trauma through incremental expansion
Solution Approach 1:
The system enables continuous or incremental adjustment of balloon diameter and internal pressure parameters during the dilation procedure. By controlling fluid injection rates and pressure levels, the balloon can expand in controlled increments rather than jumping between discrete sizes, allowing the operator to match the expansion rate to the tissue's capacity and minimize trauma.
Solution Approach 2:
The catheter system incorporates pressure sensors and feedback mechanisms that monitor the actual pressure and expansion state of the balloon in real-time. This feedback allows the system to automatically regulate fluid injection to maintain target pressures and diameters, ensuring precise control during incremental expansion and reducing the risk of tissue damage from over-expansion.
3Adaptability or versatility
If multiple discrete balloons are used for different stages, then each stage can be optimized, but the device complexity increases significantly
Solution Approach 1:
Multiple balloon stages are merged into a single continuous balloon structure that can be inflated progressively from one end to the other. This eliminates the need for multiple separate balloon components, each with its own inflation system, while still providing multi-stage expansion capability through the sequential inflation of different sections of the same balloon.
Solution Approach 2:
The multi-stage balloon is designed with nested or concentric sections that can be inflated in sequence. The proximal section is inflated first, then the distal section, creating a nested configuration where each stage is contained within the overall balloon structure. This nesting approach allows compact storage and simplified handling compared to multiple separate balloons.
Data Source
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AI summary
The embodiments disclosed herein relate to balloon dilation systems. The balloon dilation systems can include a balloon catheter assembly, an elongated member, and a balloon inflation device. The balloon catheter assembly can comprise a balloon that is configured to be expanded to a plurality of discrete diameters at a plurality of discrete pressures.