Nitinol Basket Thrombectomy Device for Embolization Prevention

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Solution Overview

Problem

Current percutaneous thrombectomy devices face challenges in safely and efficiently removing larger blood clots from pulmonary arteries due to shearing and fragmentation, leading to distal embolization and increased risk of secondary clot formation and fatalities.

Innovation Solution

A minimally invasive device using a nitinol proximal basket to encircle and remove thrombi, minimizing shearing and embolization, by deploying a catheter with a nitinol basket and funnel that expand to capture and trap the clot without fragmenting it, reducing the risk of distal embolization.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Productivity

If current percutaneous thrombectomy devices are used to remove larger blood clots, then thrombus removal is achieved, but shearing and fragmentation occur leading to distal embolization

Engineering Contradiction:
Improvethrombus removal efficiencyVSAvoiddistal embolization
Core Design Contradiction:
ProductivityVSObject-generated harmful factors

Solution Approach 1:

The device divides the thrombus removal process into distinct functional zones: the distal basket captures and contains the thrombus, while the proximal basket provides additional containment during retrieval. This segmentation prevents fragmentation and distal embolization while maintaining effective thrombus removal capability

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The device employs a nested structure where the distal basket is positioned within the proximal basket, creating concentric containment zones. This nesting allows both baskets to work together to securely hold the thrombus during the entire removal process, preventing shearing and embolization while maintaining device compactness for percutaneous access

Inventive Principle:
Principle #7Nested doll (Nesting)

2Object-affected harmful factors

If catheters are used to minimally-invasively reach and remove thrombus, then patient trauma is reduced, but device maneuverability and authority for capturing clots are limited

Engineering Contradiction:
Improvepatient traumaVSAvoiddevice maneuverability
Core Design Contradiction:
Object-affected harmful factorsVSEase of operation

Solution Approach 1:

The device utilizes dynamic control mechanisms where the operator can independently adjust the positioning and configuration of the distal and proximal baskets. This dynamic adjustability provides enhanced maneuverability and authority for capturing clots of various sizes and shapes while maintaining the minimally invasive percutaneous approach

Inventive Principle:
Principle #15Dynamics

Solution Approach 2:

The device allows for parameter changes in basket configuration, positioning, and deployment timing. By controlling the expansion and contraction of the baskets at different stages, the operator can adapt to different clot characteristics and vessel anatomies, enhancing maneuverability without compromising the minimally invasive benefit

Inventive Principle:
Principle #35Parameter changes

3Quantity of substance

If thrombi larger than catheter diameter are removed, then complete thrombus removal is achieved, but shearing and fragmentation increase

Engineering Contradiction:
Improvethrombus removal completenessVSAvoidthrombus integrity
Core Design Contradiction:
Quantity of substanceVSManufacturing precision

Solution Approach 1:

The dual-basket design segments the containment function, with the distal basket providing primary capture and the proximal basket providing secondary containment. This segmentation allows the device to handle thrombi larger than the catheter diameter while maintaining thrombus integrity through distributed containment forces

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The nested arrangement of distal and proximal baskets creates concentric containment zones that securely hold large thrombi during retrieval. This nesting structure prevents shearing and fragmentation by distributing mechanical stresses across multiple containment surfaces, preserving thrombus integrity while enabling complete removal

Inventive Principle:
Principle #7Nested doll (Nesting)

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 device effectively removes thrombi of various sizes and shapes from pulmonary arteries quickly and safely, reducing the risk of secondary clot formation and related complications, as demonstrated by reduced embolic particle loss compared to existing PMT devices.

Implementation Method 1

An invention based on the use of superelastic alloy nitinol has been developed that offers several advantages over PMT devices currently on the market

Methodology Applied
Scientific EffectSuperelasticity: Pseudoelasticity

Data Source

PatentUS12167865B2Minimally invasive thrombectomy
Publication Date: 2024.12.17 UNIVERSITY OF TOLEDO
  • US12167865B2 patent drawing
  • US12167865B2 patent drawing
  • US12167865B2 patent drawing

AI summary

A minimally invasive blood clot capturing invention made of nitinol. The nitinol is shaped into a plurality of fingers to form a frame for a basket and funnel to capture and remove blood clots. The basket and funnel being delivered to the blood clot by a catheter. The basket and funnel are capable of being collapsed within a catheter capable of being deployed into a blood vessel, and capable of being retracted into the catheter for removal from the blood vessel.