Expandable Tip Catheter for Stroke Clot Compression
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Solution Overview
Problem
Current methods for treating acute ischemic stroke often fail to quickly restore blood flow and manage clots, leading to neuronal damage and potential death, as they require careful preservation of thrombi and often involve distal embolic protection to prevent fragmentation.
Innovation Solution
An expandable tip assembly with a self-expanding scaffold is used to compress clots against vessel walls, restore blood flow, and facilitate natural lysis or mechanical fragmentation of clots, allowing embolic particles to be lysed by restored blood flow without the need for distal embolic protection, and a second device can be used for remaining clot removal.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If current methods are used to treat acute ischemic stroke, then thrombi must be carefully preserved and distal embolic protection is required, but blood flow restoration is delayed and treatment complexity increases
Solution Approach 1:
The patent extracts the thrombus from the blood vessel lumen by capturing it on the distal end of the catheter, allowing immediate blood flow restoration without requiring complex distal embolic protection systems. The thrombus is removed from the critical vascular pathway while maintaining vessel patency.
Solution Approach 2:
The catheter with distal thrombus capture capability serves as an intermediary device that simultaneously restores blood flow and manages thrombus. This single device acts as a mediator between the thrombus and the bloodstream, eliminating the need for separate protection mechanisms.
2Reliability
If distal embolic protection is implemented to prevent thrombus fragmentation, then device complexity increases, but treatment efficiency decreases
Solution Approach 1:
The catheter is designed with multi-functionality, combining distal thrombus capture, blood flow restoration, and embolic protection in a single device. This universal approach eliminates the need for multiple separate devices, thereby improving treatment efficiency while maintaining comprehensive protection.
Solution Approach 2:
The patent merges the functions of thrombus capture, embolic protection, and blood flow restoration into a single integrated catheter system. By combining these previously separate functions, the device simplifies the treatment protocol and improves operational efficiency.
3Ease of operation
If thrombi are fragmented to facilitate removal, then clot management is improved, but distal embolization risk increases
Solution Approach 1:
The catheter extracts the thrombus intact from the vessel lumen through distal capture, avoiding fragmentation entirely. The thrombus is removed as a unified structure, eliminating the harmful effect of distal embolization while maintaining ease of removal through the catheter system.
Solution Approach 2:
The patent converts the potential harm of thrombus fragmentation into a benefit by using the thrombus's natural structure to anchor it on the distal catheter end. The thrombus's tendency to fragment is harnessed to facilitate its capture and removal rather than causing distal embolization.
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
This approach enables rapid restoration of blood flow, reduces neuronal damage, and allows for effective clot management in minutes, minimizing distal embolization risks and improving treatment efficiency and safety.
Implementation Method 1
the scaffold comprising a plurality of open cells and configured to radially self-expand from a non-expanded configuration within a catheter to an expanded configuration upon unsheathing of the scaffold from the catheter
Implementation Method 2
the compression of the thrombus can restore blood flow within the blood vessel and the restored blood flow can facilitate natural lysis of the thrombus
Data Source
Figure 1
Figure 2A~2B
Figure 2C
AI summary
Systems, methods, and devices for the treatment of acute ischemic stroke that provide immediate blood flow restoration to a vessel occluded by a clot and, after reestablishing blood flow, address the clot itself. Immediate blood flow restoration advantageously can facilitate natural lysis of the clot and also can reduce or obviate the concern for distal embolization due to fragmentation of the clot. Several embodiments of the invention provide for progressive, or modular, treatment based upon the nature of the clot. For example, the progressive treatment can comprise a three-step progressive treatment process that includes immediate restoration of blood flow, in-situ clot management, and/or clot removal depending on the particular circumstances of the treatment. The in-situ clot management can include, for example, lysis and maceration. The progressive, or modular, treatment can be provided by a system or kit of one or more treatment devices.