Recapturable Funnel Catheter Assembly for Emboli Capture in DVT
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Solution Overview
Problem
Current devices for treating deep vein thrombosis (DVT) suffer from high recurrence rates, inability to handle large clot volumes, and complex treatment processes involving multiple devices and pharmaceuticals, posing significant health risks and healthcare costs.
Innovation Solution
A funnel catheter assembly with an outer and inner shaft, featuring a self-expanding funnel that can be constrained and released via a control assembly, allowing for unsheathing and sheathing during procedures to prevent vessel injury and facilitate repositioning without full withdrawal, combined with aspiration to capture emboli.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a funnel catheter is used to capture emboli during thrombus extraction, then embolic protection is improved, but the device complexity increases due to the need for unsheathing and sheathing mechanisms
Solution Approach 1:
The funnel is nested within the catheter body, allowing it to be concealed during navigation and deployed only when needed. The distal portion of the catheter contains the funnel in a compressed state during insertion, then allows expansion at the target site, effectively nesting one functional element within another to reduce overall device complexity while maintaining embolic protection capabilities
2Object-affected harmful factors
If the funnel is kept in a compressed state during movement, then vessel injury is reduced, but the ability to capture emboli is worsened
Solution Approach 1:
The funnel transitions from a compressed state during catheter movement to an expanded state during emboli capture. The system dynamically adjusts the funnel configuration based on operational phase: compressed for safe navigation and minimal vessel interaction, expanded for effective emboli capture and filtration, thereby resolving the contradiction between reducing vessel injury and maintaining emboli capture capability
3Reliability
If multiple devices and pharmaceuticals are used for DVT treatment, then treatment efficacy is improved, but the treatment process complexity increases
Solution Approach 1:
The funnel catheter integrates multiple functions into a single device: emboli capture, filtration, and protected thrombus extraction. By combining these functions that would traditionally require separate devices and pharmaceutical interventions into one integrated system, the treatment efficacy is maintained while significantly reducing procedural complexity and the number of components the operator must manage
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 funnel catheter assembly effectively prevents emboli from moving downstream, reduces vessel injury, and allows for efficient clot removal with minimal device manipulation, enhancing treatment efficacy and safety.
Implementation Method 1
a self-expanding funnel that can be constrained and released via a control assembly
Implementation Method 2
combined with aspiration to capture emboli
Data Source
Figure 1
Figure 2A~2B
Figure 3
AI summary
Systems and methods for the intravascular treatment of clot material within a blood vessel of a human patient are disclosed herein. In one embodiment, a funnel catheter assembly includes an outer shaft and an inner shaft extending through and coaxial with the outer shaft. An expandable funnel can be coupled to a distal portion of the inner shaft. The funnel catheter assembly further includes a control assembly operably coupled to the proximal portion of the outer shaft and configured to move the outer shaft between a first position and a second position. In the first position, the outer shaft is positioned at least partially over the funnel to constrain the funnel in a compressed state. In the second position, the outer shaft is retracted proximally relative to the funnel such that the funnel can expand to an expanded state.