Expandable Lumen Clearing Device for Thrombus Removal
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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 the need for a small device profile, which can lead to incomplete removal and frequent graft failure.
Innovation Solution
A device with an elongate tubular member and a guide member featuring expandable lumen clearing elements that deploy and retract to capture and aspirate material, including a cutting head for breaking up obstructive material into smaller pieces for efficient removal.
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 becomes larger which may damage body passages and reduce tracking performance
Solution Approach 1:
The device segments the aspiration pathway into two functional zones: a small-profile distal aspiration lumen for maintaining vessel access and a larger proximal collection chamber for receiving debris. This segmentation allows the distal tip to maintain a small profile for tracking while the proximal end provides sufficient space for aspiration, resolving the contradiction between aspiration capability and device profile.
Solution Approach 2:
The aspiration lumen is nested within the catheter body, with the collection chamber nested within the catheter tip structure. This nested configuration allows the aspiration functionality to be housed within the minimal profile of the distal tip, enabling effective aspiration without increasing the external diameter of the device that would damage body passages.
2Ease of operation
If a small device profile is maintained to provide desired tracking performance and avoid damaging passages, then device maneuverability is improved, but large particles obstruct the aspiration lumen preventing further aspiration
Solution Approach 1:
The device separates the aspiration function into two spatially distinct components: a small distal lumen maintained within the tracking profile and a larger proximal collection chamber. This segmentation allows the distal tip to maintain excellent tracking performance with minimal profile while the proximal chamber provides sufficient volume to collect large particles without obstructing the distal aspiration pathway, ensuring continuous aspiration capability.
Solution Approach 2:
The design transitions from a single-dimension constraint (uniform small lumen throughout) to a multi-dimensional solution where the aspiration pathway expands in the proximal dimension while remaining constrained in the distal dimension. This dimensional change allows the device to maintain small profile at the critical tracking interface while providing adequate aspiration capacity in the collection chamber dimension.
3Productivity
If existing aspiration devices are used to remove thrombus from aorto-venous grafts, then material removal is attempted, but incomplete removal occurs leading to frequent graft failure
Solution Approach 1:
The device merges multiple functional elements into an integrated system: the guide member with track lumen combines the obstruction clearing device with the aspiration pathway, the expandable lumen clearing elements combine mechanical engagement with material capture, and the cutting head combines with the collection chamber to create a comprehensive thrombus removal system. This merged design improves material removal efficiency and reduces graft failure by ensuring complete clearance.
Solution Approach 2:
The guide member acts as an intermediary structure that facilitates the interaction between the obstruction clearing device and the aspiration lumen. The track lumen serves as an intermediary pathway that guides the lumen clearing elements and enables their coordinated movement with the aspiration flow, improving the effectiveness of material removal and reducing incomplete clearance that leads to graft failure.
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 enables effective removal of thrombus and obstructive material by deploying expandable elements to capture and aspirate material, and a cutting head to break it into manageable pieces, improving the longevity of grafts and reducing the need for frequent replacements.
Implementation Method 1
The lumen clearing element(s) may include an expandable structure that is expanded from a contracted condition within the guide member to an expanded condition when deployed from the guide member
Implementation Method 2
an aspiration lumen extending between the proximal and distal ends
Implementation Method 3
a cutting head for breaking up obstructive material into smaller pieces for efficient removal
Data Source
Figure 1~2
Figure 3A~3D
Figure 3E~3G
AI summary
An apparatus is provided for removing material within a body lumen that includes a catheter including a proximal end, a distal end for introduction into a body lumen, and an aspiration lumen extending therebetween; a guide member extending from the distal end and terminating in a distal tip, the guide member comprising a track adjacent a track lumen extending from the distal tip into the aspiration lumen; and an obstruction clearing device deployable from the guide member and retractable along the track. In addition or alternatively, the apparatus includes a cutting head reciprocable within the aspiration lumen adjacent the distal end for macerating material being aspirated into the aspiration lumen.