ES2659738T3 - Detección de drogas en aliento exhalado - Google Patents

Detección de drogas en aliento exhalado Download PDF

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ES2659738T3
ES2659738T3 ES14164314.8T ES14164314T ES2659738T3 ES 2659738 T3 ES2659738 T3 ES 2659738T3 ES 14164314 T ES14164314 T ES 14164314T ES 2659738 T3 ES2659738 T3 ES 2659738T3
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exhaled breath
housing
sampling unit
subject
layer
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Göran Palmskog
Olof Beck
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SENSA BUES AB
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SENSA BUES AB
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    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N21/00—Investigating or analysing materials by the use of optical means, i.e. using sub-millimetre waves, infrared, visible or ultraviolet light
    • G01N21/62—Systems in which the material investigated is excited whereby it emits light or causes a change in wavelength of the incident light
    • G01N21/63—Systems in which the material investigated is excited whereby it emits light or causes a change in wavelength of the incident light optically excited
    • G01N21/65—Raman scattering
    • G01N21/658—Raman scattering enhancement Raman, e.g. surface plasmons
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/08—Detecting, measuring or recording devices for evaluating the respiratory organs
    • A61B5/082—Evaluation by breath analysis, e.g. determination of the chemical composition of exhaled breath
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/08—Detecting, measuring or recording devices for evaluating the respiratory organs
    • A61B5/097—Devices for facilitating collection of breath or for directing breath into or through measuring devices
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/41—Detecting, measuring or recording for evaluating the immune or lymphatic systems
    • A61B5/412—Detecting or monitoring sepsis
    • F—MECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
    • F01—MACHINES OR ENGINES IN GENERAL; ENGINE PLANTS IN GENERAL; STEAM ENGINES
    • F01D—NON-POSITIVE DISPLACEMENT MACHINES OR ENGINES, e.g. STEAM TURBINES
    • F01D1/00—Non-positive-displacement machines or engines, e.g. steam turbines
    • F01D1/02—Non-positive-displacement machines or engines, e.g. steam turbines with stationary working-fluid guiding means and bladed or like rotor, e.g. multi-bladed impulse steam turbines
    • F01D1/06—Non-positive-displacement machines or engines, e.g. steam turbines with stationary working-fluid guiding means and bladed or like rotor, e.g. multi-bladed impulse steam turbines traversed by the working-fluid substantially radially
    • F01D1/08—Non-positive-displacement machines or engines, e.g. steam turbines with stationary working-fluid guiding means and bladed or like rotor, e.g. multi-bladed impulse steam turbines traversed by the working-fluid substantially radially having inward flow
    • F—MECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
    • F01—MACHINES OR ENGINES IN GENERAL; ENGINE PLANTS IN GENERAL; STEAM ENGINES
    • F01D—NON-POSITIVE DISPLACEMENT MACHINES OR ENGINES, e.g. STEAM TURBINES
    • F01D5/00—Blades; Blade-carrying members; Heating, heat-insulating, cooling or antivibration means on the blades or the members
    • F01D5/02—Blade-carrying members, e.g. rotors
    • F01D5/04—Blade-carrying members, e.g. rotors for radial-flow machines or engines
    • F01D5/043—Blade-carrying members, e.g. rotors for radial-flow machines or engines of the axial inlet- radial outlet, or vice versa, type
    • F01D5/048—Form or construction
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01J—MEASUREMENT OF INTENSITY, VELOCITY, SPECTRAL CONTENT, POLARISATION, PHASE OR PULSE CHARACTERISTICS OF INFRARED, VISIBLE OR ULTRAVIOLET LIGHT; COLORIMETRY; RADIATION PYROMETRY
    • G01J3/00—Spectrometry; Spectrophotometry; Monochromators; Measuring colours
    • G01J3/28—Investigating the spectrum
    • G01J3/44—Raman spectrometry; Scattering spectrometry ; Fluorescence spectrometry
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/483—Physical analysis of biological material
    • G01N33/497—Physical analysis of biological material of gaseous biological material, e.g. breath
    • F—MECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
    • F05—INDEXING SCHEMES RELATING TO ENGINES OR PUMPS IN VARIOUS SUBCLASSES OF CLASSES F01-F04
    • F05D—INDEXING SCHEME FOR ASPECTS RELATING TO NON-POSITIVE-DISPLACEMENT MACHINES OR ENGINES, GAS-TURBINES OR JET-PROPULSION PLANTS
    • F05D2220/00—Application
    • F05D2220/60—Application making use of surplus or waste energy
    • F05D2220/62—Application making use of surplus or waste energy with energy recovery turbines
    • F—MECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
    • F05—INDEXING SCHEMES RELATING TO ENGINES OR PUMPS IN VARIOUS SUBCLASSES OF CLASSES F01-F04
    • F05D—INDEXING SCHEME FOR ASPECTS RELATING TO NON-POSITIVE-DISPLACEMENT MACHINES OR ENGINES, GAS-TURBINES OR JET-PROPULSION PLANTS
    • F05D2240/00—Components
    • F05D2240/20—Rotors
    • F05D2240/30—Characteristics of rotor blades, i.e. of any element transforming dynamic fluid energy to or from rotational energy and being attached to a rotor
    • F05D2240/301—Cross-sectional characteristics
    • F—MECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
    • F05—INDEXING SCHEMES RELATING TO ENGINES OR PUMPS IN VARIOUS SUBCLASSES OF CLASSES F01-F04
    • F05D—INDEXING SCHEME FOR ASPECTS RELATING TO NON-POSITIVE-DISPLACEMENT MACHINES OR ENGINES, GAS-TURBINES OR JET-PROPULSION PLANTS
    • F05D2240/00—Components
    • F05D2240/40—Use of a multiplicity of similar components
    • F—MECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
    • F05—INDEXING SCHEMES RELATING TO ENGINES OR PUMPS IN VARIOUS SUBCLASSES OF CLASSES F01-F04
    • F05D—INDEXING SCHEME FOR ASPECTS RELATING TO NON-POSITIVE-DISPLACEMENT MACHINES OR ENGINES, GAS-TURBINES OR JET-PROPULSION PLANTS
    • F05D2250/00—Geometry
    • F05D2250/50—Inlet or outlet
    • F05D2250/51—Inlet

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Physics & Mathematics (AREA)
  • General Health & Medical Sciences (AREA)
  • Pathology (AREA)
  • Molecular Biology (AREA)
  • Biomedical Technology (AREA)
  • Biophysics (AREA)
  • Chemical & Material Sciences (AREA)
  • Immunology (AREA)
  • Medical Informatics (AREA)
  • Surgery (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Physics & Mathematics (AREA)
  • Biochemistry (AREA)
  • Analytical Chemistry (AREA)
  • Physiology (AREA)
  • Pulmonology (AREA)
  • Spectroscopy & Molecular Physics (AREA)
  • Mechanical Engineering (AREA)
  • General Engineering & Computer Science (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Hematology (AREA)
  • Urology & Nephrology (AREA)
  • Food Science & Technology (AREA)
  • Medicinal Chemistry (AREA)
  • Vascular Medicine (AREA)
  • Sampling And Sample Adjustment (AREA)
  • Investigating Or Analysing Biological Materials (AREA)
  • Investigating, Analyzing Materials By Fluorescence Or Luminescence (AREA)
  • Other Investigation Or Analysis Of Materials By Electrical Means (AREA)
  • Measurement Of The Respiration, Hearing Ability, Form, And Blood Characteristics Of Living Organisms (AREA)

Abstract

Un sistema de toma de muestras portátil configurado para recoger una muestra para analizar del aliento exhalado de un sujeto, en donde dicho sistema comprende: una unidad de toma de muestras (14) y un alojamiento (12) dispuesto para sostener dicha unidad de toma de muestras (14), dicha unidad de toma de muestras (14) comprende al menos una membrana filtrante (13) que comprende dos capas donde la primera capa es una capa permeable a los gases y la segunda capa es una capa tipo fibra que está adaptada para recoger compuestos estupefacientes no volátiles de dicho aliento exhalado de dicho sujeto; dicho alojamiento (12) comprende al menos una entrada (15) adaptada para que dicho sujeto exhale en dicho alojamiento y al menos una salida (16) para que dicho aliento exhalado salga de dicho alojamiento; un elemento de boquilla desmontable que se puede conectar a dicha entrada; y caracterizado por un sensor de flujo configurado para determinar cuándo un volumen suficiente del aliento exhalado ha pasado por dicha membrana filtrante, dicho sensor de flujo está dispuesto en dicha boquilla o aguas abajo de dicha entrada.

Description

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se tendría una caída de presión aceptable. Modificando las propiedades físicas o las químicas de la membrana filtrante o quitando capas, pueden ser posibles diámetros más pequeños.
La sensibilidad del método LC/MS usado y esta membrana filtrante particular hacen posible detectar sustancias estupefacientes a partir de un aliento exhalado.
Más adelante está una tabla (tabla 3) que muestra los resultados de un estudio previo en cinco sujetos en tres ocasiones diferentes. Aquí se mide la metadona (Mtd) en aliento exhalado en pictograma por minuto de exhalación de los cinco sujetos usando tres tiempos de recogida diferentes, un tiempo de recogida en cada ocasión. Todas las mediciones fueron realizadas después de haber dispensado a los sujetos su dosis individual de metadona.
Tabla 3
Caso nº
Dosis de metadona (mg/d) Mtd pg/min 1 min Mtd pg/min 3 min Mtd pg/min 10 min
1
90 200 170 3.840
2
120 50 40 27
3
100 10.900 233 150
4
110 100 167 120
5
100 220 117 90
En la primera ocasión el sujeto exhaló durante 1 minuto, en la segunda ocasión durante tres minutos y la tercera ocasión durante 10 minutos. Excepto para el sujeto número dos que no era compatible y los valores excepcionalmente altos para el sujeto número tres y una a una de las ocasiones respectivamente, los resultados indican que son posibles tiempos de recogida cortos e incluso deberían ser realizables tiempos de recogida más cortos usando esta membrana filtrante particular dado que la sensibilidad del método LC-MS permite detecciones de cantidades inferiores que las medidas. La cantidad medida de sustancia estupefaciente también se podría obtener mediante un volumen de filtro pequeño desde el que extraer. Esto según lo que se ha descrito previamente.
La Fig. 5 es una ilustración esquemática que ilustra una realización de un sistema portátil 50 configurado para recoger una muestra a partir del aliento exhalado de un sujeto 51. El sujeto exhalará a través de la boquilla 52 que está en comunicación fluida con un alojamiento 54 a través al menos de una entrada 53. El alojamiento comprende una unidad de toma de muestras 55 que es o bien un elemento de recogida o bien comprende un elemento de recogida para recoger sustancias estupefacientes a partir del aliento exhalado. El aliento exhalado sale del alojamiento a través de al menos una salida 56. La unidad de toma de muestras 55 y/o el elemento de recogida se envía a un laboratorio 57 para ser analizado. En algunas realizaciones del sistema portátil 50 el alojamiento 54 podría ser la unidad de toma de muestras 55.
La unidad de toma de muestras 55 podría comprender más de un elemento de recogida y/o el alojamiento 54 podría comprender más de una unidad de toma de muestras, en cualquier combinación, adecuada para recoger sustancias estupefacientes. Esto hará posible discriminar entre diferentes sustancias estupefacientes, haciendo así el análisis más fácil de llevar a cabo. La unidad de toma de muestras 55 comprende al menos una membrana filtrante, pero podría incluir una pila de membranas filtrantes con diferentes propiedades físicas y/o químicas. Pero también se podrían usar múltiples filtros empleando una unidad de toma de muestras 55 que comprendiera zonas ajustadas con distintas membranas filtrantes.
El sistema de toma de muestras y los elementos para recoger sustancias estupefacientes se deberían mantener limpios y preferiblemente ser asépticos pero no necesitan ser estériles.
La Fig. 6 es un diagrama de flujo que ilustra un método 60 para usar un sistema portátil configurado para recoger una muestra 62 de aliento exhalado y para detectar la presencia o determinar la cantidad cuantitativa 63 de al menos una sustancia estupefaciente en la muestra recogida. El método comprende las etapas de: Un sujeto que exhala 61 en el sistema portátil inventado; una unidad de toma de muestras recogerá una muestra 62 que comprende sustancias estupefacientes; la muestra recogida se analizará usando espectroscopía de masas 63.
En la Fig. 7 se muestran cromatogramas 70 de la identificación de anfetamina (A) y metanfetamina (B) en el aliento exhalado de un sujeto después del consumo de “anfetamina”. Aquí Y está representando la respuesta (CPS) y X el tiempo (min). Los datos de orina y plasma analizados convencionalmente del mismo sujeto tomados por razones de comparación sugieren posibles consumos de metanfetamina con anfetamina. La identificación usando una unidad de toma de muestras y un análisis LC-MS-MS se basó en la presencia de compuestos con tiempo de retención correcto
8
y con abundancia relativa correcta de dos iones de producto. La identificación de los analitos detectados se basó en un tiempo de retención relativo correcto (para anfetamina d5). Se monitorizaron dos iones de producto de las moléculas protonadas para anfetamina (m/z 136 ->119 75; 136 ->91 73) dos para metanfetamina (m/z 150 ->119 76; 150 ->91 74). Ninguno de los sujetos de control sin consumo de drogas mostró ninguno de estos picos cuando se
5 analizó desde la unidad de toma de muestras implementada. De esta manera, la detección de anfetamina (A) y metanfetamina (B) en las muestras de aliento exhalado se demuestra de manera fiable. Más adelante se dan ejemplos adicionales.
Con referencia a la Figura 6 se usa un esquema de flujo para ilustrar el método inventado. Un sujeto exhalará 61 dentro y fuera o bien durante un cierto tiempo o un número fijo de veces tales como de 1 a 10 veces en un sistema
10 portátil. Cuando se respira un número fijo de veces cada exhalación se podría fijar que dure un tiempo fijo. La exhalación también se podría realizar hasta que se haya obtenido un cierto volumen de aliento exhalado. Se prefiere una respiración profunda para alcanzar el aliento exhalado de las partes de pulmones que están profundas tales como las regiones pulmonares central o la periférica.
El aliento exhalado entonces se recogerá 62 mediante la unidad de toma de muestras que comprende al menos un
15 elemento adecuado para recoger sustancias estupefacientes antes de que salga del sistema. Después se extraerá la unidad de toma de muestras de manera que se pueda analizar 63 el al menos un elemento adecuado para recoger sustancias estupefacientes usando un método de espectroscopía de masas adecuado. Alternativamente, para algunas de las realizaciones descritas previamente, se podría enviar a analizar el alojamiento entero.
9

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EP (6) EP2765421A1 (es)
JP (2) JP5992328B2 (es)
CN (1) CN102498398B (es)
AU (1) AU2010294183B2 (es)
BR (1) BR112012005198A8 (es)
CA (2) CA2771830C (es)
DK (1) DK2765420T3 (es)
EA (1) EA023922B1 (es)
ES (2) ES2484515T3 (es)
HU (1) HUE038136T2 (es)
MX (1) MX2012002976A (es)
NO (1) NO2765420T3 (es)
TR (1) TR201802101T4 (es)
WO (2) WO2011029889A1 (es)
ZA (1) ZA201201304B (es)

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