Expandable Lumen Clearing Device for Thrombus Aspiration
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Solution Overview
Problem
Existing medical devices face challenges in effectively removing thrombus and obstructive material from aorto-venous grafts and blood vessels due to limited aspiration capabilities and risk of damaging the vessels during procedures.
Innovation Solution
A device with an elongate tubular member and a guide member featuring expandable lumen clearing elements that can be deployed and retracted to capture and aspirate material, along with an optional cutting head for breaking up obstructive material, allowing for efficient removal while minimizing vessel damage.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Productivity
If a relatively large aspiration lumen is provided in a catheter to facilitate aspiration, then aspiration capability is improved, but the device profile increases and tracking performance deteriorates
Solution Approach 1:
The device divides the aspiration function into two separate components: a separate aspiration catheter with a large lumen for efficient aspiration, and a separate guide member with a small profile for navigation and tracking. This segmentation allows each component to be optimized independently for its specific function.
Solution Approach 2:
The guide member acts as an intermediary that provides a small-profile pathway for the obstruction clearing device while the actual aspiration is performed through a separate, larger lumen in the aspiration catheter. This intermediary structure enables the system to achieve both small profile and large aspiration lumen capabilities.
2Length of moving object
If the aspiration lumen is kept small to maintain a small device profile, then tracking performance is improved, but large particles obstruct the aspiration lumen and prevent further aspiration
Solution Approach 1:
The system separates the navigation function (performed by the small-profile guide member) from the aspiration function (performed by the larger aspiration catheter). This allows the aspiration catheter to have a large lumen capable of handling large particles while maintaining overall device profile through the use of the separate guide member.
Solution Approach 2:
The guide member extends beyond the distal end of the aspiration catheter, creating an additional spatial dimension for the obstruction clearing device to operate in. This allows the system to address particle obstruction issues by operating in the extra space provided by the extended guide member.
3Productivity
If an obstruction clearing device is deployed to remove material from the body lumen, then material removal effectiveness is improved, but the complexity of the device increases
Solution Approach 1:
The obstruction clearing device is nested within the guide member structure, with the core wire slidable within the track lumen and the lumen clearing elements deployable from the distal tip. This nested configuration allows multiple functions (guidance, obstruction clearing, and aspiration) to be integrated into a unified structure, reducing overall device complexity.
Solution Approach 2:
The guide member serves multiple functions: it provides a pathway for the obstruction clearing device, offers a track for the core wire, provides a distal tip for engagement with material, and facilitates deployment and retraction of the lumen clearing elements. This multi-functionality reduces the need for separate components, thereby reducing device complexity.
Data Source
AI summary
A method for removing material within a body lumen of a patient is disclosed. The method include introducing a distal end of a tubular member into a body lumen. The tubular member has a guide member extending distally from the distal end. Next, the tubular member is positioned such that the distal end is disposed adjacent material to be removed and a distal tip of the guide member is disposed beyond the material. One or more lumen clearing elements are then deployed from the distal tip of the guide member. Each lumen clearing element includes an expandable structure that expands from a contracted condition within the guide member to an expanded condition when deployed from the distal tip. Then, the deployed one or more lumen clearing elements are retracted along a track of the guide member to engage the material disposed adjacent the distal end of the tubular member and draw the material into a lumen of the tubular member.