Nitinol Clot Retrieval Basket for Hard Thrombi
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Solution Overview
Problem
Current intravascular thrombus and foreign body removal devices are ineffective in removing organized hard thrombi, often causing embolization and vessel injury due to their design, which lacks the necessary strength, flexibility, and ability to dislodge clots from vessel walls without proximal occlusion.
Innovation Solution
A deployable system featuring a distal body with memory metal strips that expand to capture and encase clots, allowing for safe retrieval without vessel occlusion, using a pull wire and catheter to navigate and deploy the device within blood vessels, ensuring the clot is securely entrapment and removed without causing further ischemia.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Strength
If current thrombus removal devices are used, then the device can be delivered through vessels, but the device lacks strength to dislodge hard thrombi from vessel walls
Solution Approach 1:
The device utilizes shape memory alloy (Nitinol) that changes its mechanical properties through temperature changes. The alloy transitions from a compliant state at lower temperatures during delivery to a stronger, more rigid state at body temperature, enabling the device to dislodge hard thrombi without causing vessel wall injury during retrieval
Solution Approach 2:
The device combines Nitinol shape memory alloy with radiopaque markers and coating layers to create a composite structure that provides both the necessary mechanical strength for thrombus removal and reduced risk of vessel wall damage through controlled material properties
2Ease of operation
If the device is made small and flexible to navigate tortuous vessels, then the device can be delivered through microcatheters, but the device lacks the strength to remove organized hard thrombi
Solution Approach 1:
The Nitinol alloy structure allows the device to be delivered in a compressed, flexible state through microcatheters, then transforms into a stronger, more rigid configuration at body temperature to effectively remove hard thrombi, resolving the contradiction between deliverability and thrombus removal capability
Solution Approach 2:
The device dynamically changes its mechanical properties in response to temperature changes, transitioning from a flexible delivery state to a strong retrieval state, enabling it to navigate tortuous vessels and then effectively remove organized hard thrombi
3Reliability
If the device expands to capture the clot, then the device can securely entrap the thrombus, but the device cannot be retrieved without proximal occlusion which risks further ischemia
Solution Approach 1:
The shape memory alloy changes its structural properties at body temperature, allowing the device to expand and securely entrap the thrombus, then maintain this expanded configuration during retrieval without requiring proximal occlusion, thereby eliminating the risk of further ischemia while ensuring reliable clot capture
4Ease of operation
If the device is designed to be retrievable into the microcatheter, then the device can be removed after use, but the device lacks sufficient strength to dislodge strongly adherent thrombus
Solution Approach 1:
The Nitinol alloy's temperature-dependent shape memory effect allows the device to be delivered in a compressed state through the microcatheter, then transform into a stronger configuration at body temperature to dislodge adherent thrombus, while maintaining the ability to be retrieved into the microcatheter for removal
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 system effectively removes hard thrombi by securely capturing and retrieving clots, reducing the risk of embolization and vessel injury, while maintaining the ability to be reused and deployed in tortuous vessels without the need for proximal occlusion.
Implementation Method 1
the distal body has a relaxed state wherein the distal body has a first height and width and a collapsed state wherein the distal body has a second height and width
Data Source
AI summary
A platform of devices for removing obstructions and other objects within a blood vessel or other interior lumen of an animal is provided. The system may be deployed in the lumen from a catheter(s) and the system includes a proximal junction, and a distal basket comprised of a plurality of cells. A number of different basket designs are disclosed.


