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ES2649984T3 - Aparato para aliviar el dolor utilizando estimulación eléctrica transcutánea de nervios - Google Patents

Aparato para aliviar el dolor utilizando estimulación eléctrica transcutánea de nervios Download PDF

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Publication number
ES2649984T3
ES2649984T3 ES12850140.0T ES12850140T ES2649984T3 ES 2649984 T3 ES2649984 T3 ES 2649984T3 ES 12850140 T ES12850140 T ES 12850140T ES 2649984 T3 ES2649984 T3 ES 2649984T3
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stimulation
intensity
housing
threshold
sensation
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Shai N. Gozani
Xuan Kong
Andres Aguirre
Glenn Herb
Marc Cryan
Michael Williams
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Neurometrix Inc
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Neurometrix Inc
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/36014—External stimulators, e.g. with patch electrodes
    • A61N1/36021—External stimulators, e.g. with patch electrodes for treatment of pain
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/372—Arrangements in connection with the implantation of stimulators
    • A61N1/37211—Means for communicating with stimulators
    • A61N1/37235—Aspects of the external programmer
    • A61N1/37247—User interfaces, e.g. input or presentation means
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/02—Details
    • A61N1/04—Electrodes
    • A61N1/0404—Electrodes for external use
    • A61N1/0408—Use-related aspects
    • A61N1/0456—Specially adapted for transcutaneous electrical nerve stimulation [TENS]
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/02—Details
    • A61N1/04—Electrodes
    • A61N1/0404—Electrodes for external use
    • A61N1/0472—Structure-related aspects
    • A61N1/0476—Array electrodes (including any electrode arrangement with more than one electrode for at least one of the polarities)
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/02—Details
    • A61N1/04—Electrodes
    • A61N1/0404—Electrodes for external use
    • A61N1/0472—Structure-related aspects
    • A61N1/0492—Patch electrodes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/321—Electromedical belts
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/36014—External stimulators, e.g. with patch electrodes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/36014—External stimulators, e.g. with patch electrodes
    • A61N1/3603—Control systems
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/36014—External stimulators, e.g. with patch electrodes
    • A61N1/3603—Control systems
    • A61N1/36034—Control systems specified by the stimulation parameters
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/36014—External stimulators, e.g. with patch electrodes
    • A61N1/3603—Control systems
    • A61N1/36031—Control systems using physiological parameters for adjustment

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • General Health & Medical Sciences (AREA)
  • Biomedical Technology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Radiology & Medical Imaging (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Biophysics (AREA)
  • Pain & Pain Management (AREA)
  • Human Computer Interaction (AREA)
  • Electrotherapy Devices (AREA)

Abstract

Un aparato para la estimulación transcutánea de nervios en seres humanos, comprendiendo el aparato: un alojamiento; medios de estimulación montados dentro del alojamiento para estimular eléctricamente los nervios; una configuración de electrodos montada de manera liberable en el alojamiento y que se puede conectar a los medios de estimulación, comprendiendo la configuración de electrodos una pluralidad de electrodos para la estimulación eléctrica de los nervios; medios de control montados en el alojamiento y conectados eléctricamente a los medios de estimulación para controlar al menos una característica de los medios de estimulación; medios de interfaz de usuario montados en el alojamiento y conectados eléctricamente a los medios de control para controlar los medios de estimulación; y una correa unida al alojamiento; en donde la correa está configurada para sujetar el alojamiento, los medios de estimulación y la configuración de electrodos en una posición anatómica específica para el tratamiento del dolor; caracterizado por que los medios de control están configurados para determinar la intensidad de estimulación terapéutica para estimular eléctricamente los nervios, en donde los medios de control están adaptados de tal manera que la intensidad de estimulación terapéutica se determina: haciendo que los medios de estimulación apliquen estimulación eléctrica transcutánea de nervios a un paciente a una primera intensidad de estimulación; haciendo que los medios de estimulación aumenten automáticamente la intensidad de estimulación desde dicha primera intensidad de estimulación hasta que un umbral de sensación electrotáctil sea identificado por el usuario utilizando los medios de interfaz de usuario; y calculando la intensidad de estimulación terapéutica a partir del umbral de sensación electrotáctil añadiendo automáticamente un desfase de intensidad predeterminado a la intensidad de estimulación asociada con el umbral de sensación electrotáctil.

Description

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umbral de sensación por un factor multiplicador.
La realización descrita de la invención se puede mejorar más dado que el factor multiplicador es 2.
La realización descrita de la invención se puede mejorar más dado que el factor multiplicador es una función de los factores demográficos.
La realización descrita de la invención se puede mejorar más dado que los factores demográficos incluyen la edad, género, peso y altura del paciente.
La realización descrita de la invención se puede mejorar más dado que el factor multiplicador es una función de factores biométricos.
La realización descrita de la invención se puede mejorar más dado que los factores biométricos incluyen la circunferencia de la pantorrilla del paciente.
La realización descrita de la invención se puede mejorar más dado que el factor multiplicador es una función de los factores fisiológicos.
La realización descrita de la invención se puede mejorar más dado que los factores fisiológicos incluyen la temperatura superficial de la piel, la respuesta galvánica de la piel, la actividad electromiográfica y la bioimpedancia.
La realización descrita de la invención se puede mejorar más dado que el factor multiplicador es una función de al menos uno de los umbrales de sensación determinados anteriormente.
La realización descrita de la invención se puede mejorar más dado que el factor multiplicador es una función de al menos una intensidad de estimulación previamente utilizada.
La realización descrita de la invención se puede mejorar más dado que la intensidad de estimulación terapéutica es calculada a partir de una pluralidad de medidas de umbral de sensación.
La realización descrita de la invención se puede mejorar más dado que la intensidad de estimulación terapéutica se calcula a partir del promedio de una pluralidad de umbrales de sensación.
La realización descrita de la invención se puede mejorar más dado que la intensidad de estimulación terapéutica se calcula a partir de la media de la pluralidad de umbrales de sensación.
En otra forma preferida de la presente invención, se proporciona un método para determinar la intensidad de estimulación terapéutica para la estimulación eléctrica transcutánea de nervios en un paciente, comprendiendo el método las etapas de:
aplicar estimulación eléctrica al paciente a una primera intensidad de estimulación; incrementar automáticamente la intensidad de la estimulación eléctrica al paciente desde la intensidad de estimulación hasta una segunda intensidad en la que el umbral de sensación electrotáctil se identifica; y calcular la intensidad de estimulación terapéutica a partir de dicho segundo nivel de intensidad.
En otra forma preferida de la presente invención se proporciona un método para tratar el dolor en un paciente utilizando estimulación eléctrica transcutánea de nervios, comprendiendo el método las etapas de:
determinar automáticamente la intensidad de estimulación terapéutica;
iniciar la estimulación eléctrica a la intensidad de estimulación terapéutica;
ajustar la intensidad de estimulación terapéutica bajo el control de paciente;
aumentar automáticamente la intensidad de estimulación terapéutica a una velocidad predeterminada; y
continuar la estimulación eléctrica durante un periodo de tiempo.
La realización descrita de la invención se puede mejorar más dado que el dolor es un dolor crónico.
La realización descrita de la invención se puede mejorar más dado que el dolor crónico es causado por la neuropatía diabética dolorosa.
La realización descrita de la invención se puede mejorar más dado que la intensidad de estimulación terapéutica es incrementada automáticamente para superar los efectos de la habituación de nervio.
La realización descrita de la invención se puede mejorar más dado que la intensidad de estimulación terapéutica aumenta automáticamente por un factor multiplicador en un intervalo fijo.
9
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intensidad que esté dentro de la ventana terapéutica. El enfoque tradicional en la TENS es que el personal médico forme a los pacientes acerca de cómo incrementar manualmente la intensidad de la estimulación de TENS hasta que los pacientes perciban la sensación "fuerte pero no dolorosa" deseada. Es entonces responsabilidad del paciente realizar posteriormente este proceso cuando sea necesario, por ejemplo en casa cuando la terapia de TENS sea necesaria. Sin embargo, este enfoque de la técnica anterior requiere el uso de recursos médicos caros (es decir, tiempo de personal médico) y es propenso a error ya que los pacientes previamente formados pueden olvidar como determinar una intensidad terapéutica apropiada. Como resultado, un objetivo principal de la presente invención es el ajuste de forma automática y fiable la intensidad de estimulación dentro del rango terapéutico.
La presente invención describe un método para ajustar automáticamente la intensidad de estimulación a un nivel terapéutico, un procedimiento denominado a veces "configuración". Este método se basa en el concepto de mapeado de la escala de percepción electrotáctil del paciente, en el que se representa la sensación "fuerte pero no dolorosa", a una escala de intensidad de estimulación eléctrica medida en miliamperios. En este sentido, el término "electrotáctil" hace referencia a la sensación de estimulación eléctrica del paciente. Hay tres valores clave de percepción electrotáctil medibles: el umbral de sensación electrotálctil (es decir el nivel, más bajo de estimulación ecléctica que el paciente puede sentir), el umbral de dolor electrotálctil (es decir, el nivel de estimulación eléctrica que produce dolor al paciente), y el umbral de tolerancia electrotáctil (es decir, el máximo nivel de estimulación eléctrica que puede ser tolerado por el paciente). Una intensidad de estimulación de TENS óptima esta situada entre el umbral de sensación electrotáctil y el umbral de dolor electrotáctil.
La Fig. 8 muestra una curva 300 que ilustra la relación entre la intensidad de estimulación eléctrica 302 y la percepción electrotáctil 304. La pendiente de la curva 300 es pronunciada cerca del umbral de sensación electrotáctil 306, de manera que el rango 308 de intensidades de estimulación I(s), que puede provocar primero la sensación en el paciente es generalmente estrecho. Como resultado, el umbral de sensación electrotáctil 306, y la correspondiente intensidad de estimulación 308, es decir I(s), se pueden determinar fácilmente.
El umbral de dolor electrotáctil 310, que está definido como el nivel en el que la sensación de estimulación eléctrica cambia de confortable a dolorosa, no está bien definido y está influenciado por múltiples factores fisiológicos y psicológicos. Como resultado, la curva 300 no está tan inclinada en la religión de umbral de dolor electrotáctil 310 como en la región de umbral de sensación electrotáctil 306. Esto puede conducir a un amplio rango 312 de intensidades de estimulación I(p), en el que se produce la transición al dolor. Por esta razón, puede ser difícil medir de forma fiable el umbral de dolor electrotáctil 310, y la correspondiente intensidad de estimulación 312. Otra desventaja con la medida del umbral de dolor electrotáctil 310 es que necesita estimulación con intensidades de corriente que estén en el límite superior del rango confortable del paciente y, debido a la variación en el umbral de dolor exacto 310, puede ocasionalmente ser percibida como dolor. En consecuencia, un paciente puede subestimar constantemente su umbral de dolor, lo que conduce a un nivel de estimulación que esté por debajo del rango terapéutico óptimo si el nivel terapéutico es estimado a partir del umbral de dolor electrotáctil 310.
Dado que la intensidad de estimulación I(s) asociada con el umbral de sensación electrotáctil 306 puede ser calculada de forma fiable, la intensidad de estimulación terapéutica objetivo I(t), que proporciona una sensación "fuerte pero no dolorosa", se puede calcular añadiendo un desfase de intensidad I(o) a la intensidad de estimulación I(s) asociada con el umbral de sensación electrotáctil. En otras palabras, cuando I(s) es la intensidad de estimulación asociada con el umbral de sensación electrotáctil, el desfase de intensidad I(o) se puede añadir a la intensidad de estimulación I(s) de manera que se determina la intensidad de estimulación I(t) que sea "fuerte pero no dolorosa", es decir terapéuticamente efectiva y todavía cómoda para el paciente. Este es un nuevo e innovador método para determinar una intensidad de estimulación que sea fuerte pero no dolorosa para el paciente.
Una realización preferida de este procedimiento para ajustar automáticamente la intensidad de estimulación a un nivel terapéutico para incrementar gradualmente la intensidad de estimulación desde 0 mA hasta que el paciente indique que la estimulación es sentida primero, es decir, que se haya alcanzado el umbral de sensación electrotáctil, tal como utilizando el botón pulsador 106. En una realización preferida, la intensidad de estimulación es una progresión geométrica. Por ejemplo, la intensidad de estimulación puede aumentar un 5% cada segundo (es decir, la intensidad de estimulación es de 1,05 veces la intensidad de estimulación anterior). El beneficio de una progresión geométrica es que encaja mejor con la relación exponencial de la intensidad de estimulación y la sensación electrotáctil (es decir, la denominada "ley de energía psicofísica") que realiza un incremento lineal de la intensidad (por ejemplo, 1 mA por segundo). El proceso se puede repetir múltiples veces para permitir una estimación más precisa del umbral de sensación electrotáctil y la intensidad asociada I(s), tal como tomando el promedio o la media de múltiples medidas. En una realización preferida, la primera determinación del umbral de sensación electrotáctil es descartada debido a que el paciente no puede estar familiarizado con la percepción de la estimulación eléctrica y puede por lo tanto subestimar o sobreestimar el nivel correcto.
Un incremento de intensidad de estimulación, es decir, un desfase de intensidad I(o), es entonces añadido a la intensidad de estimulación I(s) asociada con el umbral de sensación electrotáctil para estimar la intensidad terapéutica I(t), 316.
En una realización preferida, el desfase de intensidad de estimulación I(o) es una constante para todos los
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Claims (1)

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ES12850140.0T 2011-11-15 2012-11-15 Aparato para aliviar el dolor utilizando estimulación eléctrica transcutánea de nervios Active ES2649984T3 (es)

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US201161560029P 2011-11-15 2011-11-15
US201161560029P 2011-11-15
US201261657382P 2012-06-08 2012-06-08
US201261657382P 2012-06-08
PCT/US2012/065311 WO2013074809A1 (en) 2011-11-15 2012-11-15 Apparatus and method for relieving pain using transcutaneous electrical nerve stimulation

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US (5) US8948876B2 (es)
EP (1) EP2780073B1 (es)
JP (2) JP6130851B2 (es)
KR (1) KR20140098782A (es)
CN (2) CN107376115A (es)
AU (2) AU2012340365B2 (es)
CA (1) CA2854904C (es)
DK (1) DK2780073T3 (es)
ES (1) ES2649984T3 (es)
PL (1) PL2780073T3 (es)
PT (1) PT2780073T (es)
WO (1) WO2013074809A1 (es)

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