Helical Balloon Assist Device for Neurovascular Navigation
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Solution Overview
Problem
Existing balloon guide catheters for vascular surgery have a large profile and limited flexibility, making them difficult to navigate in neurovascular anatomy, particularly due to the integral balloon design, which restricts their use mainly to proximal cerebral vasculature.
Innovation Solution
A helical balloon assist device with a tubular balloon and an inner core member formed in an independent helical shape, which can be secured to the balloon or act as a separate component, allows for a more compact and flexible design that can be inflated to occlude blood vessels, facilitating navigation through tighter bends in the vasculature.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Quantity of substance
If a large lumen balloon is used to maximize clot capture, then the balloon can effectively capture clots, but the overall profile of the device becomes very large making it difficult to navigate in neurovascular anatomy
Solution Approach 1:
The balloon is nested within the guide catheter in a collapsed state during insertion, allowing the device to pass through small access sites. Upon deployment, the balloon expands to its full size to maximize clot capture capacity. This nesting approach allows the device to have a small delivery profile while maintaining large clot capture capability.
Solution Approach 2:
The balloon transitions from a static small profile during delivery to a dynamic expanded state during operation. The balloon can be inflated and deflated as needed, allowing it to adapt its size - small for navigation through neurovascular anatomy and large for effective clot capture and restriction.
2Reliability
If an integral balloon design is used to control flow, then flow control is achieved, but the overall flexibility of the system is decreased
Solution Approach 1:
The device is segmented into separate functional components - the guide catheter and the balloon are distinct elements that can be independently manipulated. The balloon can be inflated or deflated independently of the catheter's navigation through the vasculature, allowing flexible positioning followed by stable flow control when needed.
Solution Approach 2:
The balloon's flexibility is dynamically adjusted through inflation and deflation. When deflated, the balloon maintains system flexibility for navigation. When inflated, it provides stable flow control and restriction. This dynamic state change allows the system to alternate between flexible navigation mode and stable occlusion mode.
3Reliability
If a dual layer construction is used to inflate the distal balloon, then the balloon can be inflated for occlusion, but the tracking of the device in neurovascular anatomy becomes difficult
Solution Approach 1:
The balloon construction dynamically changes from a flexible single-layer state during tracking to a reinforced dual-layer state during occlusion. The dual layer construction is only activated when the balloon is inflated, allowing easy tracking during navigation while providing reliable occlusion when deployed.
Solution Approach 2:
The balloon is prepared in a simple, flexible configuration before deployment to facilitate easy tracking through neurovascular anatomy. The more complex dual-layer construction is only assembled or activated when the balloon reaches its deployment position, ensuring optimal tracking performance before the balloon is needed for occlusion.
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 helical balloon assist device enables more precise and flexible occlusion of blood vessels, allowing for procedures in areas previously inaccessible due to its reduced profile and enhanced tracking capabilities within the vasculature.
Implementation Method 1
The inner core member can be formed of a resilient material
Implementation Method 2
the positioner is the inflation tube. The positioner can be configured to position the helical balloon assist device in a radial direction
Implementation Method 3
inflating the balloon of the helical balloon assist device causes at least a partial occlusion of a patient's blood vessel adjacent to the treatment site
Data Source
AI summary
The helical balloon assist device includes a tubular balloon formed at least partially into an independent helical shape in an uninflated state and an inflation tube in sealed communication with the balloon and extending from the helical balloon assist device in a proximal direction. The helical balloon assist device may include an inner core member formed at least partially into an independent helical shape and supporting the helical shape of the tubular balloon.