Detachable-Tip Balloon Microcatheter for Reflux-Controlled Embolization
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Solution Overview
Problem
Current embolization techniques for vascular pathologies, particularly AVMs, face challenges such as embolic agent reflux, catheter entrapment, procedural complexity, and inefficiency, leading to increased complications and prolonged procedural times.
Innovation Solution
A detachable-tip balloon microcatheter system that combines a detachable tip with a protective sheath, allowing for controlled embolic agent delivery and reflux prevention, using a dual-lumen design with a detachable tip assembly and inflatable balloon to facilitate complete embolization.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of manufacture
If a non-detachable catheter is used for embolization, then the catheter structure is simple and easy to manufacture, but the catheter may become entrapped in the embolic agent cast requiring significant force for removal
Solution Approach 1:
The catheter is divided into two separable parts: a proximal catheter body and a distal tip assembly. The detachment zone with radiopaque markers allows the tip to be separated from the body after embolization, enabling easy removal of the proximal catheter while leaving the tip embedded in the embolic cast.
Solution Approach 2:
Radiopaque markers are introduced as intermediary elements at the detachment zone. These markers provide visual feedback to guide the detachment process and serve as a mediator between the operator's control and the separation mechanism, ensuring controlled detachment at the intended location.
2Ease of operation
If a detachable-tip microcatheter is used for embolization, then catheter entrapment is reduced, but embolic agent reflux into non-target vessels occurs
Solution Approach 1:
A balloon is inflated at the distal end of the catheter before embolic agent injection to create a proximal plug. This preliminary action occludes the vessel upstream of the injection site, preventing embolic agent reflux into non-target vessels while allowing the detachable tip to function for easy removal.
Solution Approach 2:
The balloon is nested within the catheter structure, allowing it to be deployed from the catheter lumen. The balloon can be inflated to create an occlusive plug while remaining contained within the catheter framework, enabling dual functionality of embolization and reflux prevention.
3Object-affected harmful factors
If balloon microcatheter is used for embolization, then embolic agent reflux is prevented, but the device complexity increases with additional components
Solution Approach 1:
The detachable-tip microcatheter and balloon microcatheter functions are merged into a single integrated device. The catheter incorporates both the detachable tip assembly for easy removal and the inflatable balloon for reflux prevention, eliminating the need for separate devices and reducing overall procedural complexity.
4Reliability
If dual microcatheter technique is used for embolization, then complete embolization of complex AVMs is achieved, but procedural time and complexity increase
Solution Approach 1:
The single microcatheter device performs multiple functions that previously required two separate catheters: it provides detachable-tip functionality for easy removal, balloon inflation for reflux prevention, and embolic agent delivery. This multi-functionality maintains complete embolization capability while reducing procedural time and complexity.
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 system reduces embolic agent reflux, minimizes catheter entrapment, and enhances procedural efficiency, enabling safer and more comprehensive embolization with reduced radiation exposure and healthcare costs.
Implementation Method 1
inflation of a proximal balloon microcatheter allows improved flow control
Implementation Method 2
The balloon portion of the Scepter C acts as a plug to ensure flow control of the embolic agent
Implementation Method 3
The detachable tip microcatheter incorporates a detachment zone that allows separation of the catheter when the catheter main body is retracted
Implementation Method 4
liquid embolic agents, or solid embolic agents... the rate of complete obliteration of the lesion... before the liquid embolic material hardens
Data Source
Figure 1
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AI summary
A detachable tip sheathed balloon microcatheter is provided for delivering an embolic agent to a target location for the embolization of an arteriovenous malformation (AVM). The detachable tip sheathed balloon microcatheter including a balloon microcatheter including a first shaft and an inflatable balloon that is coupled to a distal end portion of the first shaft; and a detachable tip assembly that is configured to be detachably coupled to the first shaft of the balloon microcatheter. The detachable tip assembly includes a protective balloon sheath that is coupled to a proximal end portion of the second shaft, wherein when the detachable tip assembly is coupled to the balloon microcatheter, the protective balloon sheath surrounds at least a portion of the inflatable balloon.