Detachable Balloon Embolization with Check-Valve Inflation Control
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Solution Overview
Problem
Existing embolization devices face challenges with lack of control, consistency, large profiles, difficulty in tracking, high learning curve, and high costs, particularly in treating wide neck aneurysms and large vessel bleeding, with risks of nontarget embolization and complications.
Innovation Solution
A detachable balloon embolization device with a cannula, guide wire lumen, inflation lumen, and a valve sleeve, allowing precise placement, quick inflation, and easy detachment, using a friction fit mechanism for controlled deployment and retention in the desired location.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If traditional embolization devices are used, then embolization can be performed, but the devices have large profiles making them difficult to track and deliver precisely
Solution Approach 1:
The embolization device is divided into multiple components: a catheter for delivery, a balloon for occlusion, and a detachment mechanism. This segmentation allows the device to be delivered through a small-profile catheter while the balloon expands at the target site to provide precise occlusion.
Solution Approach 2:
The balloon is nested within the catheter during delivery, allowing the device to pass through small vessels with a small profile. Once at the target location, the balloon is inflated to its full size to achieve precise embolization.
2Reliability
If embolization devices are deployed, then blood flow can be blocked, but control over the embolization process is limited
Solution Approach 1:
The balloon is positioned at the target site through the catheter before inflation. This preliminary positioning allows the operator to verify correct placement using imaging techniques before committing to the embolization procedure, enhancing control over the process.
Solution Approach 2:
The device transitions from a compressed, deliverable state within the catheter to an expanded, functional state when the balloon is inflated. This dynamic transformation provides controlled embolization, allowing the operator to maintain control throughout the procedure by managing the inflation/deflation cycles.
3Ease of manufacture
If existing embolization methods are used, then treatment can be provided, but costs are high and learning curve is steep
Solution Approach 1:
The embolization device is designed as a disposable single-use system, eliminating the need for expensive sterilization and maintenance infrastructure. This reduces overall system costs while simplifying the learning curve, as operators do not need to manage complex reusable device protocols.
4Productivity
If embolization is performed quickly, then treatment efficiency improves, but precision and safety may be compromised
Solution Approach 1:
The embolization process uses periodic inflation and deflation of the balloon. The balloon can be inflated to test occlusion, deflated to adjust positioning, and re-inflated to achieve precise embolization. This periodic action allows rapid treatment while maintaining precision through iterative adjustment.
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 provides controlled, quick, and safe embolization with precise placement, minimizing risks of nontarget embolization and complications, and is cost-effective compared to existing solutions.
Implementation Method 1
When liquid or gas is introduced through the inflation lumen on the cannula, the balloon device is inflated
Implementation Method 2
The valve sleeve forms a check valve that allows inflation of the balloon via an inflation channel in the microcatheter, but prevents leakage of the inflation medium from the balloon once inflated
Implementation Method 3
The balloon device is detachably mounted on the distal end of a catheter... using a friction fit mechanism for controlled deployment and retention
Data Source
AI summary
A balloon embolization apparatus, system and method include a detachable balloon device mounted to the distal end of a catheter or microcatheter. The balloon device includes an elongated cannula having first and second axial lumens defined in the cannula, one lumen which allows for travel over a wire, an inflatable balloon disposed on the cannula, and a valve sleeve disposed between the balloon and the cannula. An inflation port on the cannula allows fluid to be introduced to the balloon via a channel in the catheter. The valve sleeve includes a vent offset from the inflation port in the cannula. The valve sleeve allows the introduced fluid to inflate the balloon, but prevents the fluid from escaping, thereby forming a check valve. Once inflated, the catheter is detached from the balloon apparatus. When the catheter is withdrawn, the balloon remains in place to allow for embolization.