Adjustable Tip Aspiration Catheter for Intracranial Clot Removal
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Solution Overview
Problem
Existing intracranial aspiration catheters face challenges in navigating tortuous blood vessels due to fixed beveled tips, which can lead to reduced tracking efficiency and increased risk of accidental punctures, affecting the ability to effectively remove clots in the brain during acute ischemic stroke treatment.
Innovation Solution
An aspiration catheter with an adjustable tip mechanism, utilizing pull wires to change the tip from round to beveled and back, allowing for real-time configuration to improve navigation and suction efficiency, featuring a flexible tube made from memory alloys and a hydrophilic coating for enhanced maneuverability and clot capture.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a fixed beveled tip is used on the aspiration catheter, then the catheter can provide effective suction for clot removal, but the catheter experiences reduced tracking efficiency and increased risk of accidental punctures in tortuous blood vessels
Solution Approach 1:
The catheter tip is designed with a dynamic shape-changing mechanism using shape memory alloy (Nitinol) material that can transition between a rounded configuration (for safe navigation through tortuous vessels) and a beveled configuration (for effective clot aspiration). This dynamic adaptation allows the catheter to optimize its shape based on the operational phase, resolving the contradiction between safe tracking and effective suction.
Solution Approach 2:
The catheter employs a pull-wire mechanism that changes the geometric parameters of the tip by applying tension to reshape the Nitinol memory alloy from a rounded form to a beveled form. This parameter change enables the tip to switch between configurations that are optimal for different operational requirements: rounded for navigation and beveled for aspiration.
2Stability of the object's composition
If the catheter tip is made rigid to improve structural stability, then the catheter can maintain its shape for precise clot capture, but the catheter becomes less maneuverable in complex intracranial vessels
Solution Approach 1:
The catheter incorporates a flexible Nitinol memory alloy tip that can bend and conform to tortuous vessel paths during navigation, yet maintains sufficient structural integrity to hold its configured shape when positioned for aspiration. The flexible material properties enable the tip to adapt to complex intracranial geometry while preserving the ability to capture clots effectively.
Solution Approach 2:
The tip transitions from a flexible, adaptive state during navigation to a stable, configured state during aspiration. The shape memory alloy material allows the tip to be dynamically reshaped by the pull-wire mechanism, providing maneuverability when needed and structural stability when required for precise clot capture.
3Productivity
If a beveled tip configuration is used continuously to improve aspiration efficiency, then the catheter can effectively suction clots, but the catheter loses the ability to navigate tortuous blood vessels safely
Solution Approach 1:
The catheter tip dynamically switches between rounded and beveled configurations based on the operational phase. During navigation through tortuous vessels, the tip maintains a rounded shape that minimizes vessel injury risk. Upon reaching the target location, the pull-wire mechanism transforms the tip to a beveled configuration that optimizes aspiration efficiency for clot removal.
Solution Approach 2:
The catheter performs preliminary navigation with a safe, rounded tip configuration before transitioning to the aspirational beveled configuration. This preliminary action ensures safe passage through complex vasculature before the tip is reshaped for its primary function of clot aspiration, preventing vessel injury before it can occur.
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 adjustable tip mechanism enhances the catheter's ability to navigate complex intracranial vessels, improves first-pass efficiency, and reduces the risk of vessel injury, allowing for effective clot removal and improved brain function restoration in acute ischemic stroke treatment.
Implementation Method 1
wherein tension on the first pull wire causes the first side of the adjustable tip to recede toward the proximal end, and tension on the second pull wire causes the second side of the adjustable tip to recede toward the proximal end
Implementation Method 2
the adjustable tip comprises a first region of nitinol coil with a braid, and a second region of nitinoil coil with a braid
Implementation Method 3
a hydrophilic coating for enhanced maneuverability
Data Source
AI summary
An aspiration catheter useful for intracranial thrombus removal is described, along with methods of using the same. The aspiration catheter includes an adjustable tip having sides that are adjustable by an operator through the use of pull wires that extend along, and protrude from, the aspiration catheter.