Electrically Enhanced Clot Retrieval Device
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Solution Overview
Problem
Current medical devices for removing clot material from blood vessels face challenges such as clot detachment during retrieval, especially at bifurcations and tortuous anatomy, leading to secondary strokes due to incomplete clot removal and risk of clot fragmentation.
Innovation Solution
An electrically enhanced retrieval device with a positively charged interventional element, utilizing a multi-component core assembly with integrated delivery and return electrodes, applies a direct current electrical signal to attract negatively charged clot components, improving attachment and retention without causing tissue ablation or new clot formation, using specific waveform and power delivery parameters.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Productivity
If a stent is deployed to push the clot to the side of the vessel, then blood flow is re-established, but the clot may detach during retrieval and cause secondary blockages
Solution Approach 1:
The retrieval device is pre-configured with an expandable basket structure and engagement arms that are prepared to capture the clot before retrieval begins. The device is advanced to the clot location in a compressed state, then expanded to engage the clot, ensuring secure attachment before the retrieval process starts.
Solution Approach 2:
The retrieval device utilizes changes in structural parameters through expansion and contraction of the basket. The device transitions from a low-profile compressed state for navigation to an expanded state for clot engagement and retrieval. This parameter change allows the device to adapt to different operational phases while maintaining secure clot retention.
2Ease of operation
If the stent drags the clot through tortuous anatomy and bifurcations, then the clot is retrieved to the catheter, but the clot may detach at bifurcations or tortuous segments
Solution Approach 1:
The retrieval device incorporates dynamic engagement arms that can actively track and follow the contours of tortuous vessels and bifurcations. These arms are designed to flex and adapt to the vessel geometry, maintaining continuous contact with the clot throughout the retrieval process through complex anatomy, thereby preventing detachment at challenging segments.
Solution Approach 2:
The retrieval device is divided into multiple functional segments including the expandable basket, engagement arms, and connecting structure. This segmentation allows different parts of the device to perform specialized functions - the basket provides overall structure, while the engagement arms specifically handle clot contact and retention, improving overall reliability during navigation through complex anatomy.
3Manufacturing precision
If multiple device passages are performed to ensure complete clot removal, then retrieval completeness is improved, but procedure time increases and risk of secondary strokes rises
Solution Approach 1:
The retrieval device is designed with pre-positioned engagement structures and an expandable basket that is ready to capture the clot in a single pass. The device is advanced to the clot location, expanded to engage the clot, and retrieved in one continuous motion, eliminating the need for multiple passages and reducing procedure time while maintaining complete clot removal.
Solution Approach 2:
The retrieval device integrates multiple functions into a single device including clot capture, secure retention, navigation through tortuous anatomy, and retrieval to the catheter. This multi-functionality allows the device to handle the entire clot removal process in one pass, improving both completeness and efficiency while reducing procedure time and associated risks.
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 solution enhances clot capture and retention, reducing the number of device passages required for complete retrieval, minimizing the risk of secondary strokes by maintaining grip on the clot during retrieval, even through complex vascular anatomy.
Implementation Method 1
utilizing a multi-component core assembly with integrated delivery and return electrodes, applies a direct current electrical signal to attract negatively charged clot components
Data Source
Figure 1A
Figure 1B~1C
Figure 2A
AI summary
Retrieval of material from vessel lumens can be improved by electrically enhancing attachment of the material to the removal device. The removal device can have a core assembly that includes a hypotube coupled to a first electrical terminal and a pushwire coupled to a second electrical terminal, the pushwire extending through the hypotube lumen. An insulating layer separates the hypotube and the pushwire, and an interventional element is coupled to a distal end of the pushwire. The interventional element can be disposed adjacent to a thrombus. An electrical signal is delivered to the interventional element to promote adhesion of the thrombus to the interventional element. The electrical signal can optionally be a periodic waveform, and the total energy delivered can be between 0.75-24,000 mJ and the peak current delivered via the electrical signal can be between 0.5-5 mA.