Inflatable Balloon Occlusion Device for Side Branch Vessels
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Solution Overview
Problem
Existing medical balloons for occluding blood vessels are not suitable for long-term use, as they can cause vascular trauma, displace within the vessel, and fail to reliably occlude side branch lumens due to instability and high inflation pressures, leading to risks of ischemia, embolism, and vascular damage.
Innovation Solution
A medical device comprising a collapsible and expandable inflatable balloon with a support structure that maintains a longitudinal fluid flow passage while providing a counterforce to prevent displacement, allowing for controlled occlusion of side branch lumens without increasing inflation pressure, and is designed for transluminal delivery and deployment with a self-expanding or wire-controlled support structure.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If an inflatable balloon is used to occlude a vessel, then temporary occlusion is achieved, but the balloon may displace within the vessel due to blood flow pressure
Solution Approach 1:
The patent applies preliminary action by positioning the balloon catheter across the side branch lumen opening before inflation. The balloon is advanced to the target site and positioned against the vessel wall, then inflated to create occlusion. This preliminary positioning ensures the balloon is correctly placed before the occlusion action begins, preventing displacement during the procedure.
Solution Approach 2:
The patent uses an intermediary approach by employing a guide catheter and guidewire to deliver the balloon catheter to the target site. The guide catheter acts as an intermediary device that provides a stable pathway for balloon delivery and positioning, allowing precise placement against the side branch lumen opening before inflation occurs.
2Reliability
If higher inflation pressure or larger balloon diameter is used to prevent displacement, then occlusion reliability improves, but vascular trauma increases
Solution Approach 1:
The patent applies local quality by using a balloon diameter that is larger than the side branch lumen opening but carefully controlled to avoid excessive compression of the main vessel. The occlusion is localized precisely to the side branch opening while maintaining adequate blood flow through the main lumen, preventing vascular trauma through targeted rather than diffuse compression.
Solution Approach 2:
The patent uses partial action by occluding only the side branch lumen opening while maintaining patency of the main vessel. The balloon is inflated to a degree sufficient to block the side branch flow but not so much as to cause trauma to the main vessel wall, achieving the minimum necessary occlusion without excessive force.
3Device complexity
If a standard dilation balloon is used, then the procedure is simple, but the balloon cannot reliably occlude side branch lumens due to instability
Solution Approach 1:
The patent applies dynamics by using an inflatable balloon that can change its dimensions from a compressed delivery state to an expanded occlusion state. The balloon is delivered in a collapsed configuration through the catheter, then inflated at the target site to engage the side branch lumen opening, providing dynamic adaptation to the anatomical structure for reliable occlusion.
Solution Approach 2:
The patent uses nesting by placing the balloon catheter inside a guide catheter during delivery. The balloon catheter is nested within the guide catheter, which provides structural support and guidance, allowing the simpler balloon structure to achieve reliable side branch occlusion through the combined system rather than requiring a complex standalone device.
4Reliability
If total occlusion of a coronal vessel is achieved, then side branch flow is blocked, but heart thump or skip and angina may occur
Solution Approach 1:
The patent applies segmentation by separating the occlusion function from the main vessel flow path. The balloon is positioned to occlude only the side branch lumen opening while leaving the main vessel patent. This segmented approach blocks flow to the side branch (achieving reliable occlusion) while maintaining blood flow through the main vessel (preventing ischemia and cardiac complications).
Solution Approach 2:
The patent uses local quality by creating a localized occlusion at the side branch opening rather than total vessel occlusion. The balloon is positioned and inflated to affect only the specific side branch lumen while the main vessel continues to carry blood flow, preventing systemic ischemic effects while achieving the desired side branch blockage.
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 device effectively occludes side branch lumens while maintaining blood flow through the main vessel, reducing vascular trauma and the risk of embolism, and can be used in high-flow applications near the heart without disrupting cardiac output, ensuring patient safety and versatility in various surgical procedures.
Implementation Method 1
The first inflatable balloon is adapted to be inflated with a fluid to an inflated state in which the first balloon surrounds an inner hollow and provides a counterforce
Implementation Method 2
The support structure, when in an expanded state, is configured to support a patency of the inner hollow of the first balloon in the inflated state thereof
Data Source
Figure 1~2
Figure 3~4
Figure 5~6
AI summary
A medical system is disclosed that has three basic components; a retractable sheet, a first balloon (10) that has a centrally arranged hollow, and a collapsible/expandable support structure (20) at thehollow. The first balloon (10) is for instance mounted/molded onto the exterior surface of the support structure (20). The aggregate of support structure (20) and the first balloon (10) is positioned,and once the sheet has been retracted from the first balloon, the first balloon (10) is inflated. The support structure (20) may be self-expandable or expandable by an expansion unit, such as a further balloon arranged at its inside. The lumen of the support structure (20) is chosen to be smaller than that of a main lumen (80). The outside diameter of the inflated first balloon (10) is chosen to be larger than the interior diameter of the main lumen (80). This procedure may be done using standard Seldinger technique and fluoroscopy. This makes the system user friendly and increases patient safety,as a well established clinical method may be used with some modifications according to the invention.