Double-Balloon Catheter for Reliable Stent Deployment
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Solution Overview
Problem
Existing balloon catheters face challenges in deploying medical devices like stents and stent grafts across varying lumen diameters, as they either fail to achieve full expansion or result in inadequate anchoring due to the non-compliant nature of expansion balloons, which can lead to improper deployment and potential risks such as migration or inadequate sealing.
Innovation Solution
A double-balloon catheter design featuring an outer balloon made of elastic material that stretches from a minimum to a maximum deployment diameter, with an inner balloon of non-compliant material providing a reliable expansion force, allowing for proper deployment across a range of diameters without over-expansion, and enabling a single-stage deployment operation.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a non-compliant balloon is used to expand the medical device, then the device achieves reliable anchoring and proper deployment shape, but the balloon cannot adapt to varying lumen diameters and may not achieve full expansion
Solution Approach 1:
The balloon catheter is divided into two distinct balloon segments: an inner non-compliant balloon that provides reliable expansion force and shape control, and an outer compliant balloon that adapts to varying lumen diameters. This segmentation allows each balloon to perform its specialized function, resolving the contradiction between deployment reliability and adaptability.
Solution Approach 2:
The inner non-compliant balloon is nested within the outer compliant balloon. This nested configuration allows the inner balloon to maintain its rigid expansion characteristics while being contained and supported by the outer balloon that can stretch to accommodate different lumen sizes, thus achieving both reliability and adaptability simultaneously.
2Adaptability or versatility
If a compliant balloon is used to adapt to varying lumen diameters, then the balloon can stretch to fit different sizes, but it cannot provide sufficient expansion force for reliable device deployment
Solution Approach 1:
The balloon system is segmented into an outer compliant balloon that adapts to lumen diameter variations and an inner non-compliant balloon that generates the necessary expansion force. This functional segmentation resolves the contradiction between adaptability and expansion force capability.
Solution Approach 2:
The inner non-compliant balloon acts as an intermediary that transfers expansion force to the medical device. While the outer compliant balloon adapts to the lumen, the inner balloon provides the mechanical force needed for reliable device deployment, mediating between the compliant outer structure and the device requiring expansion.
3Manufacturing precision
If the balloon diameter is larger than the lumen diameter, then the device can be fully expanded, but the balloon cannot be properly wrapped onto the introducer for deployment
Solution Approach 1:
The outer balloon is designed with dynamic properties that allow it to be compressed and wrapped onto the introducer in a compact state, then expand to its full diameter during deployment. This dynamic behavior resolves the contradiction between achieving full expansion precision and ease of wrapping for deployment.
Solution Approach 2:
The outer compliant balloon utilizes flexible shell properties that enable it to be folded and wrapped around the introducer in a compact configuration, then expand to its full diameter during the procedure. This flexibility resolves the contradiction between expansion precision and ease of wrapping.
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 double-balloon catheter ensures reliable and consistent deployment of medical devices across varying lumen diameters, providing robust anchoring and sealing without the need for additional fixation mechanisms, while preventing over-expansion and allowing for efficient deployment in a single stage.
Implementation Method 1
the outer balloon is made of an elastic material able to stretch from the minimum to the maximum deployment or dilatation diameters
Implementation Method 2
the inner balloon is made of a non-compliant material which is intended to provide a superior expansion force
Data Source
AI summary
An introducer assembly (10) includes a balloon catheter (12) for deploying a medical device (19) in a body lumen or for dilating a body lumen at a range of diameters from a minimum deployment diameter to a maximum deployment diameter. The balloon catheter includes an outer balloon (42) and an inner balloon (40) located within the outer balloon (42). The outer balloon (42) has an unstretched diameter equivalent to the minimum deployment diameter and the inner balloon (40) has an unstretched diameter equivalent to the maximum deployment diameter. The outer balloon (42) is made of an elastic material able to stretch from the minimum deployment diameter to the maximum deployment diameter, while the inner balloon (40) is preferably of an non-compliant material.