Acoustic Wave Medical Device for Consistent Cell Extraction

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Solution Overview

Problem

Fine-Needle Aspiration (FNA) techniques face challenges due to user-dependency, high variability in cell extraction, and limited capability to maintain tissue structure, leading to inconclusive diagnoses and increased costs, while core needle biopsy (CNB) is costly and invasive, and alternative methods like bone sampling are painful.

Innovation Solution

A medical device utilizing a conduit with a displacement signal source generating acoustic or mechanical waves to facilitate controlled movement and pressure for efficient cell extraction and tissue sampling, reducing user variability and improving sample quality without the need for invasive procedures.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Ease of manufacture

If FNA is used to extract cells from target tissue, then the procedure can be conducted in a general physician's office, but there is high intra-user and inter-user variability in the yield of obtained cells and limited capability to maintain tissue structure

Engineering Contradiction:
Improveprocedure accessibilityVSAvoidcell extraction yield consistency
Core Design Contradiction:
Ease of manufactureVSMeasurement precision

Solution Approach 1:

The patent replaces the manual mechanical manipulation of FNA with an automated system that uses ultrasonic vibrations transmitted through the needle to detach cells from tissue. The ultrasonic transducer generates high-frequency mechanical vibrations that are transmitted through the needle to the tissue interface, eliminating the need for manual needle manipulation and suction control, thereby reducing user variability while maintaining procedural simplicity

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

Solution Approach 2:

The patent applies mechanical vibration in the form of ultrasonic frequencies to the needle, which transmits these vibrations to the target tissue. This ultrasonic vibration creates micro-mechanical stress at the tissue-needle interface that effectively detaches cells without requiring manual manipulation, thereby improving extraction consistency while preserving tissue architecture

Inventive Principle:
Principle #18Mechanical vibration

2Object-affected harmful factors

If FNA is used to extract cells from target tissue, then the procedure is less invasive, but potentially pathological cells may not be extracted if there is a high collagenous connective tissue component

Engineering Contradiction:
Improveprocedure invasivenessVSAvoidsample acquisition success rate
Core Design Contradiction:
Object-affected harmful factorsVSReliability

Solution Approach 1:

The ultrasonic vibrations transmitted through the needle create micro-mechanical stress that effectively breaks down collagenous connective tissue barriers without requiring larger needle diameters. This allows the fine needle to penetrate and extract cells from dense tissue environments that would be inaccessible to conventional FNA, thereby improving sample acquisition reliability while maintaining minimal invasiveness

Inventive Principle:
Principle #18Mechanical vibration

Solution Approach 2:

The patent changes the physical parameters of the extraction process by introducing ultrasonic frequency vibrations to the needle. This parameter change enables the needle to interact with and penetrate collagenous connective tissue that would otherwise resist conventional FNA, thereby improving the reliability of sample acquisition from difficult-to-access tissues

Inventive Principle:
Principle #35Parameter changes

3Reliability

If CNB is used to extract tissue samples, then the probability of acquiring potentially pathological cells is greater, but the procedure is costly and cannot be conducted at the general practitioner's office

Engineering Contradiction:
Improvesample acquisition probabilityVSAvoidprocedure complexity
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The patent merges the advantages of both FNA and CNB by combining the fine needle approach with ultrasonic vibration technology. This hybrid system achieves the tissue penetration capability and sample acquisition reliability of CNB while maintaining the procedural simplicity and accessibility of FNA, thereby eliminating the need for complex surgical equipment and specialized facilities

Inventive Principle:
Principle #5Merging (Combining)

Solution Approach 2:

The patent replaces the complex mechanical system of CNB with a simpler automated system that uses ultrasonic vibrations. This substitution eliminates the need for manual tissue manipulation and complex suction control required in CNB, thereby simplifying the procedure while maintaining high sample acquisition probability and enabling it to be performed in general physician offices

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

4Quantity of substance

If CNB is used to extract tissue samples, then more tissue volume is obtained, but the patient is subjected to bleeding and other adverse effects due to greater instrument diameter

Engineering Contradiction:
Improvetissue sample volumeVSAvoidpatient adverse effects
Core Design Contradiction:
Quantity of substanceVSObject-affected harmful factors

Solution Approach 1:

The ultrasonic vibrations transmitted through the fine needle create micro-mechanical stress that effectively detaches cells and small tissue fragments from the target tissue. This vibration-based mechanism compensates for the smaller needle diameter, allowing adequate sample volume to be obtained without the bleeding and trauma associated with larger CNB instruments

Inventive Principle:
Principle #18Mechanical vibration

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 enhances sample volume and precision, reduces user variability, and allows for non-invasive procedures, improving diagnostic accuracy and patient safety by using controlled acoustic or mechanical waves to extract cells while maintaining tissue structure.

Implementation Method 1

a displacement signal source for generating a displacement signal including an acoustic wave or a mechanical wave

Methodology Applied
Scientific EffectAcoustic wave: Sound

Implementation Method 2

a displacement signal source for generating a displacement signal including an acoustic wave or a mechanical wave

Methodology Applied
Scientific EffectMechanical wave: Vibration

Implementation Method 3

a pressure controller coupled to a first end of the conduit and being configured to vary an amount of pressure in the conduit during use

Methodology Applied
Scientific EffectPressure control: Pressure Increase

Data Source

PatentEP3478188B1Apparatus for extracting and delivery of entities
Publication Date: 2023.11.08 SWAN CYTOLOGICS INC
  • EP3478188B1 patent drawingFigure 1A
  • EP3478188B1 patent drawingFigure 1B~1L
  • EP3478188B1 patent drawingFigure 1M~1S

AI summary

Various embodiments are described herein for a device for using acoustic or mechanical energy to perform an action at a target site of an object. The device comprises a conduit having an aperture disposed at the target site, a displacement signal source for generating a mechanical displacement signal, a coupling assembly having for coupling the displacement signal source to the conduit, a pressure controller coupled to the proximal end of the conduit to vary an amount of pressure in the conduit when obtaining a first entity from or delivering a second entity to the target site, and a control unit for controlling the displacement signal source to generate the mechanical displacement signal based on a desired acoustic or mechanical wave mode.