Bidirectional Thrombus-Breaking Device With Periodic Rotation Stops

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Solution Overview

Problem

Existing methods for removing thrombi in biological lumens, such as deep vein thrombosis, face challenges in effectively destroying thrombi due to the difficulty in managing the rotation of mechanical breaking members, which can result in incomplete thrombus destruction and potential drug side effects.

Innovation Solution

A medical device with a long shaft portion and a breaking member that rotates in alternating directions, controlled by a drive unit and a control unit, interposing stops between rotations to enhance the relative speed and shear stress on the thrombi, facilitating effective destruction.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If a rotating structure is used to destroy a thrombus in a lumen, then the thrombus attached to the vessel wall can be effectively destroyed, but the embolus floating in the lumen rotates together with the rotating structure making it difficult to destroy

Engineering Contradiction:

Improvethrombus destruction effectivenessVSAvoiddifficulty in destroying floating embolus

Core Design Contradiction:

ReliabilityVSEase of operation

Solution Approach 1:

The drive unit is configured to rotate the shaft in alternating forward and reverse directions periodically. This periodic bidirectional rotation creates varying shear stress patterns that can effectively disrupt both attached thrombi and floating emboli, solving the problem of ineffective destruction of floating embolus while maintaining reliability for attached thrombus destruction.

Inventive Principle:

Principle #19Periodic action

2Ease of manufacture

If a drug such as a thrombolytic agent is injected to dissolve a thrombus, then the thrombus can be removed, but side effects such as bleeding occur

Engineering Contradiction:

Improvethrombus removal effectivenessVSAvoidbleeding side effects

Core Design Contradiction:

Ease of manufactureVSObject-affected harmful factors

Solution Approach 1:

The patent replaces chemical thrombolytic agents with a mechanical destruction system consisting of a rotating shaft with breaking members. This mechanical approach physically fragments the thrombus through shear stress and rotational force, achieving effective thrombus removal without the bleeding side effects associated with pharmacological thrombolytics.

Inventive Principle:

Principle #28Mechanics substitution (Replace mechanical system)

3Productivity

If continuous rotation is used to destroy thrombus, then destruction efficiency is maintained, but floating embolus rotates together with the structure reducing relative speed and shear stress

Engineering Contradiction:

Improvethrombus destruction efficiencyVSAvoidrelative speed between breaking member and embolus

Core Design Contradiction:

ProductivityVSSpeed

Solution Approach 1:

The drive unit implements periodic bidirectional rotation, alternating between forward and reverse directions. This creates periodic changes in rotation direction that prevent floating emboli from synchronizing with the shaft rotation, maintaining high relative speed and shear stress throughout the destruction process while preserving overall destruction efficiency.

Inventive Principle:

Principle #19Periodic action

Solution Approach 2:

The system alternates the direction of rotation between forward and reverse. By inverting the rotation direction periodically, the breaking members engage floating emboli from opposite directions, preventing the emboli from rotating synchronously with the shaft and maintaining effective shear stress for destruction.

Inventive Principle:

Principle #13The other way round (Inversion)

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 breaks thrombi by creating high shear stress and relative speed, ensuring thorough destruction while minimizing entanglement and drug usage, and allows for efficient aspiration and thrombolysis.

Implementation Method 1

rotating the shaft portion by the drive unit, stopping the rotation of the drive unit, and rotating the drive unit again... creating high shear stress and relative speed

Methodology Applied

Scientific EffectShear stress: Shear Stress

Data Source

PatentUS12414795B2Medical device, method for controlling rotation of medical device, and rotation controller

Publication Date: 2025.09.16 TERUMO KK

AI summary

A medical device is disclosed that can effectively destroy an object in a biological lumen, a method for controlling rotation of the medical device, and a rotation controller. The medical device to be inserted into a biological lumen to destroy a thrombus in the biological lumen includes an elongated shaft portion that is rotationally driven, a drive unit that rotates the shaft portion, a breaking member that is provided at a distal portion of the shaft portion and is rotatable, and a control unit that controls the rotation of the drive unit, in which the control unit controls the drive unit to repeat the rotation while interposing a stop of the rotation between rotations of the drive unit.