Dual Expandable Clot Retrieval Catheter for Complete Occlusion Capture
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Solution Overview
Problem
Current medical devices for removing occlusions, such as thrombi, are limited in their effectiveness, reliability, and ease of use, particularly in large vascular structures and calcified materials, and often fail to capture small portions of occlusions, leading to potential embolization and increased complexity due to fixed-diameter instrumentation and multiple catheters.
Innovation Solution
A catheter-based device with independently controllable proximal and distal expandable elements, allowing dynamic sizing and capture of occlusions through a handle with multiple manipulable interfaces, enabling flexible expansion and contraction to match the target object's size and shape, along with a suction mechanism for complete removal.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If current devices use fixed-diameter instrumentation and multiple catheters, then they can remove occlusions from vessels, but the device complexity increases and the ability to capture small portions of occlusions decreases
Solution Approach 1:
The device is divided into multiple independently controllable expandable elements (proximal and distal elements) that can be selectively expanded. This segmentation allows each element to independently capture portions of the occlusion, improving capture completeness while reducing the need for multiple separate catheters.
Solution Approach 2:
The single catheter-based device performs multiple functions: it can expand proximal and distal elements independently to capture occlusions of varying sizes, navigate through vessels, and remove material. This multi-functionality replaces the need for multiple specialized catheters, reducing overall device complexity while improving reliability.
2Ease of operation
If current devices use wire structures to compress into embolic material, then they can attempt extraction, but they fail to provide distal protection and may cause embolization
Solution Approach 1:
The distal expandable element is deployed beforehand to create a protective barrier at the distal end of the occlusion. This pre-positioned element prevents embolic material from traveling distally during the extraction process, cushioning against the harmful effect of embolization while maintaining ease of operation.
Solution Approach 2:
The expandable elements act as intermediaries between the extraction mechanism and the occlusion material. These elements provide a controlled interface that allows material removal while preventing direct contact between sharp or harmful surfaces and the embolic material, thereby reducing embolization risk.
3Ease of manufacture
If current devices require predetermined device length selection at insertion, then they can be deployed, but they cannot adapt to the actual size of the target thrombus
Solution Approach 1:
The device transitions from a static predetermined length design to a dynamic configurable structure. The proximal and distal expandable elements can be selectively expanded or collapsed based on the actual size of the target thrombus, allowing the device to adapt its dimensions during the procedure while maintaining ease of deployment.
Solution Approach 2:
The device allows changes in dimensional parameters (length, diameter) of the expandable elements based on the specific requirements of each patient and occlusion. This parameter adaptability enables the same device to effectively treat occlusions of varying sizes without requiring multiple predetermined device lengths.
4Reliability
If current catheter-based systems use fixed-diameter inflatable bodies, then they can encapsulate occlusions, but they cannot flexibly adjust expansion or contraction diameter
Solution Approach 1:
The single inflatable body is segmented into multiple independently controllable expandable elements. Each element can be selectively expanded or collapsed, allowing flexible adjustment of the overall diameter and configuration to match the target occlusion size while maintaining reliable encapsulation capability.
Solution Approach 2:
The device transitions from a fixed-diameter inflatable body to a dynamic structure with variable expandability. The proximal and distal elements can independently change their expansion state, enabling the device to adapt its diameter and shape to different occlusion sizes while maintaining the reliability of encapsulation.
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
Enhances the ability to capture a larger percentage of occlusions without causing embolization, simplifies device navigation, and reduces the need for multiple catheters by allowing dynamic sizing and adjustment within the vessel or cavity.
Implementation Method 1
the first physically manipulable interface is adapted to mechanically expand or contract the proximal expandable element independent of the distal expandable element
Implementation Method 2
along with a suction mechanism for complete removal
Data Source
AI summary
A clot removal device including a lumen, an elongated member positioned within the lumen, a handle attached to lumen, a first expandable member positioned along the elongated member, a second expandable member positioned along the elongated member, wherein the second expandable member is distal to the first expandable member relative to the handle. The handle has an actuation mechanism and a) the first expandable member is coupled to an actuation mechanism and is moveable relative to the second expandable member upon manipulation of the actuation mechanism; b) the first expandable member is configured to mechanically expand or contract by manipulating the actuation mechanism; c) the second expandable member is coupled to the actuation mechanism and is configured to be moveable relative to the first expandable member upon manipulation of the actuation mechanism; or d) the second expandable member is configured to mechanically expand or contract by manipulating the actuation mechanism.