Rotational Atherectomy Aspiration Timing for Debris Collection

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Solution Overview

Problem

Existing medical devices face challenges in effectively collecting debris from calcified lesions due to insufficient initial negative pressure during aspiration and inability to adjust the delay time between aspiration and rotation of the cutting portion, leading to potential peripheral embolization risks.

Innovation Solution

A medical device with a controller that initiates fluid aspiration first, followed by a delayed rotation of the drive shaft, allowing for adjustable delay times to ensure sufficient negative pressure before cutting begins, thereby enhancing debris collection.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If aspiration is started simultaneously with rotation of the cutting portion, then the device structure is simple, but the negative pressure is insufficient immediately after start and debris cannot be sufficiently collected

Engineering Contradiction:
Improvedebris collection effectivenessVSAvoidcontrol mechanism complexity
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The patent applies preliminary action by starting the aspiration (fluid driving source) before the cutting operation (drive shaft rotation). The controller is configured to activate the fluid driving source first to establish negative pressure in the lumen, and only after a predetermined delay period does it activate the drive shaft rotation. This ensures that sufficient negative pressure is already present to immediately collect debris when cutting begins, preventing peripheral embolization while maintaining reliable debris collection.

Inventive Principle:
Principle #10Preliminary action

2Adaptability or versatility

If a mechanical mechanism is used to delay motor start, then the device structure is simple, but the delay time cannot be adjusted and the tube may be crushed

Engineering Contradiction:
Improvedelay time adjustabilityVSAvoidcontrol system complexity
Core Design Contradiction:
Adaptability or versatilityVSDevice complexity

Solution Approach 1:

The patent replaces the mechanical delay mechanism with an electronic control system. Instead of using mechanical components to physically delay the motor start, the controller electronically manages the timing sequence by receiving a start signal, activating the fluid driving source first, and after a programmable predetermined delay period, activating the drive shaft rotation. This electronic approach provides adjustable delay times and avoids the structural weaknesses of mechanical delay mechanisms.

Inventive Principle:
Principle #28Mechanics substitution (Replace mechanical system)

Solution Approach 2:

The patent applies dynamics by making the delay period adjustable rather than fixed. The controller can be configured with different predetermined delay times depending on the specific procedural requirements, allowing optimization of debris collection for different lesion types and patient conditions. This dynamic adjustability enhances the adaptability of the device while maintaining a relatively simple control architecture.

Inventive Principle:
Principle #15Dynamics

3Reliability

If aspiration is started first with mechanical delay, then negative pressure is established before cutting, but the delay time is insufficient and cannot be optimized

Engineering Contradiction:
Improvenegative pressure establishmentVSAvoiddelay time insufficiency
Core Design Contradiction:
ReliabilityVSLoss of time

Solution Approach 1:

The patent applies dynamics by making the delay period adjustable rather than fixed. The controller can be configured with different predetermined delay times depending on the specific procedural requirements, allowing optimization of debris collection for different lesion types and patient conditions. This dynamic adjustability enhances the adaptability of the device while maintaining a relatively simple control architecture.

Inventive Principle:
Principle #15Dynamics

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 ensures reliable and efficient collection of debris by maintaining negative pressure before and after cutting, reducing the risk of peripheral embolization and improving procedural safety.

Implementation Method 1

a fluid driving source configured to move a fluid from a distal side to a proximal side of the lumen

Methodology Applied
Scientific EffectNegative pressure: Pressure Gradient

Data Source

PatentUS12484928B2Medical device
Publication Date: 2025.12.02 TERUMO KK
  • US12484928B2 patent drawing
  • US12484928B2 patent drawing
  • US12484928B2 patent drawing

AI summary

A medical device for removing an object in a body cavity, includes a rotatable drive shaft having a lumen, a cutter disposed at a distal portion of the drive shaft and by which the object is cut, a drive shaft driving source configured to rotate the drive shaft, a fluid driving source configured to move a fluid from a distal side to a proximal side of the lumen, a switch, and a controller configured to, in response to the switch being turned on, control the fluid driving source to begin moving the fluid, and control the drive shaft driving source to begin rotating the drive shaft a first predetermined period after the switch is turned on.