ES2336081T3 - Dispositivo de puncion de auto-optimizacion con medios de adaptacion a variaciones temporales en las propiedades cutaneas. - Google Patents
Dispositivo de puncion de auto-optimizacion con medios de adaptacion a variaciones temporales en las propiedades cutaneas. Download PDFInfo
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- ES2336081T3 ES2336081T3 ES02742123T ES02742123T ES2336081T3 ES 2336081 T3 ES2336081 T3 ES 2336081T3 ES 02742123 T ES02742123 T ES 02742123T ES 02742123 T ES02742123 T ES 02742123T ES 2336081 T3 ES2336081 T3 ES 2336081T3
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/15—Devices for taking samples of blood
- A61B5/150007—Details
- A61B5/150015—Source of blood
- A61B5/150022—Source of blood for capillary blood or interstitial fluid
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/15—Devices for taking samples of blood
- A61B5/150007—Details
- A61B5/150053—Details for enhanced collection of blood or interstitial fluid at the sample site, e.g. by applying compression, heat, vibration, ultrasound, suction or vacuum to tissue; for reduction of pain or discomfort; Skin piercing elements, e.g. blades, needles, lancets or canulas, with adjustable piercing speed
- A61B5/150106—Means for reducing pain or discomfort applied before puncturing; desensitising the skin at the location where body is to be pierced
- A61B5/15016—Means for reducing pain or discomfort applied before puncturing; desensitising the skin at the location where body is to be pierced by accessories for bringing the piercing element into the body, e.g. through rotation of the piercing element
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/15—Devices for taking samples of blood
- A61B5/150007—Details
- A61B5/150053—Details for enhanced collection of blood or interstitial fluid at the sample site, e.g. by applying compression, heat, vibration, ultrasound, suction or vacuum to tissue; for reduction of pain or discomfort; Skin piercing elements, e.g. blades, needles, lancets or canulas, with adjustable piercing speed
- A61B5/150167—Adjustable piercing speed of skin piercing element, e.g. blade, needle, lancet or canula, for example with varying spring force or pneumatic drive
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/15—Devices for taking samples of blood
- A61B5/150007—Details
- A61B5/150374—Details of piercing elements or protective means for preventing accidental injuries by such piercing elements
- A61B5/150381—Design of piercing elements
- A61B5/150412—Pointed piercing elements, e.g. needles, lancets for piercing the skin
- A61B5/150427—Specific tip design, e.g. for improved penetration characteristics
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/15—Devices for taking samples of blood
- A61B5/150007—Details
- A61B5/150374—Details of piercing elements or protective means for preventing accidental injuries by such piercing elements
- A61B5/150381—Design of piercing elements
- A61B5/150412—Pointed piercing elements, e.g. needles, lancets for piercing the skin
- A61B5/150435—Specific design of proximal end
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/15—Devices for taking samples of blood
- A61B5/150007—Details
- A61B5/150374—Details of piercing elements or protective means for preventing accidental injuries by such piercing elements
- A61B5/150381—Design of piercing elements
- A61B5/150503—Single-ended needles
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/15—Devices for taking samples of blood
- A61B5/151—Devices specially adapted for taking samples of capillary blood, e.g. by lancets, needles or blades
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/15—Devices for taking samples of blood
- A61B5/151—Devices specially adapted for taking samples of capillary blood, e.g. by lancets, needles or blades
- A61B5/15101—Details
- A61B5/15115—Driving means for propelling the piercing element to pierce the skin, e.g. comprising mechanisms based on shape memory alloys, magnetism, solenoids, piezoelectric effect, biased elements, resilient elements, vacuum or compressed fluids
- A61B5/15123—Driving means for propelling the piercing element to pierce the skin, e.g. comprising mechanisms based on shape memory alloys, magnetism, solenoids, piezoelectric effect, biased elements, resilient elements, vacuum or compressed fluids comprising magnets or solenoids
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/15—Devices for taking samples of blood
- A61B5/151—Devices specially adapted for taking samples of capillary blood, e.g. by lancets, needles or blades
- A61B5/15101—Details
- A61B5/15126—Means for controlling the lancing movement, e.g. 2D- or 3D-shaped elements, tooth-shaped elements or sliding guides
- A61B5/1513—Means for controlling the lancing movement, e.g. 2D- or 3D-shaped elements, tooth-shaped elements or sliding guides comprising linear sliding guides
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Abstract
Dispositivo de punción que comprende una lanceta (54) que comprende un eje provisto de un extremo de accionamiento proximal y un extremo de lanceta distal; un accionador de lanceta (52) acoplado a dicha lanceta para el desplazamiento longitudinal de dicha lanceta; un mecanismo de detección de la posición de la lanceta (74) y un controlador de lanceta (60) acoplado a dicho accionador de lanceta y dicho mecanismo de detección de posición de lanceta, pudiendo funcionar dicho controlador de lanceta para medir la localización de la lanceta (72) que utiliza el mecanismo de detección de posición (74) y para calcular el movimiento de la lanceta, comprendiendo dicho controlador de lanceta un bucle de retroalimentación para controlar el desplazamiento longitudinal de dicha lanceta y para modular el accionador de lanceta con el fin de proporcionar un perfil de punción del tejido predeterminado en términos de un desplazamiento, velocidad o aceleración con respecto a tiempo, con las fases características para el avance y la retracción de la lanceta.
Description
Dispositivo de punción de
auto-optimización con medios de adaptación a
variaciones temporales en las propiedades cutáneas.
Los dispositivos de punción son bien conocidos
en la industria de los productos de asistencia médica para
atravesar la piel a fin de obtener sangre para su análisis. El
análisis bioquímico de muestras de sangre es una herramienta de
diagnóstico para determinar información clínica. Muchas pruebas de
diagnóstico rápido se realizan utilizando sangre total capilar,
siendo la más común la que controla el nivel de glucosa en la sangre
de personas diabéticas. Otros usos para este procedimiento incluyen
la analítica de coagulación basada en la medición del tiempo de
protrombina. Típicamente, se obtiene una gota de sangre para este
tipo de análisis realizando una pequeña incisión en la punta del
dedo, creando una pequeña herida que genera una gotita de sangre en
la superficie de la piel.
Los procedimientos de punción más antiguos
incluían la perforación o el corte de la piel con una aguja o
cuchilla. Los procedimientos actuales utilizan accionadores de
lanceta que contienen una multitud de resortes, levas y actuadores
de masa para accionar la lanceta. Éstos incluyen resortes en
voladizo, diafragmas, resortes en espiral, así como sondas de
gravedad utilizadas para actuar la lanceta. Típicamente, el
dispositivo está precargado, o el usuario carga el dispositivo.
Dicho dispositivo se sujeta contra la piel y el usuario, o la
presión de la piel del usuario, acciona de forma mecánica el
lanzamiento balístico de la lanceta. El movimiento hacia adelante,
y la profundidad de la penetración en la piel de la lanceta se
determinan por medio de un tope mecánico y/o la amortiguación, así
como por un resorte o leva que retrae la lanceta.
Los dispositivos actuales generalmente confían
en amortiguadores o topes mecánicos regulables para controlar la
profundidad de la penetración de la lanceta, con el fin de compensar
el grosor y la hidratación de la piel.
Dichos dispositivos presentan la posibilidad de
múltiples golpes debido al retroceso, además de la estimulación
vibratoria de los nervios seccionados cuando el accionador impacta
con el extremo del tope del lanzador. Las levas pueden ofrecer un
control estricto de la velocidad de la lanceta al entrar y salir de
la piel, pero no permiten una compensación por el grosor y la
hidratación de la piel. Las variaciones en el grosor y la
hidratación de la piel pueden comportar distintos resultados en
términos de percepción del dolor, producción de sangre y
satisfacción en la obtención de sangre de distintos usuarios del
dispositivo de punción.
El documento GB 2.335.990 describe un aparato
provisto de un eje que puede detectar la profundidad de penetración,
para penetrar en un sustrato con una impedancia que varía
dependiendo de la profundidad bajo una superficie del sustrato.
Dicho eje está provisto de una punta para la penetración y cuenta
con extremos conductores próximos a dicha punta del eje. Se puede
detectar un cambio en la impedancia del material entre los extremos
conductores para proporcionar información acerca de la profundidad
de la penetración.
La patente US nº 6.171.325 describe un aparto de
múltiples ejes para realizar una incisión en un sustrato de
material elástico suave, como un tejido humano. El aparato para
realizar incisiones incluye dos o más ejes de incisión, estando,
cada uno de los mismos, provisto de un borde distal. Los ejes no
están fijados entre sí y se pueden deslizar el uno contra el otro
para accionar los bordes distales de forma alternativa contra el
sustrato para realizar una incisión en el mismo.
El documento EP 1.101.443 describe el uso de una
bobina acústica sustancialmente sin fijación en un dispositivo de
punción en coordinación y combinación con un imán estacionario y un
circuito electrónico en un dispositivo de punción. Cuando un
usuario inicia dicho dispositivo de punción electrónico, la fuente
de voltaje del interior de dicho dispositivo de punción electrónico
proporciona suficiente corriente a través de la bobina acústica
como para que la bobina y la lanceta se repelan del imán y sean
impulsadas al lugar de la punción. Posteriormente, la fuente de
voltaje invierte la corriente a través de la bobina acústica para
suministrar suficiente corriente de atracción a través de dicha
bobina acústica como para que se retraiga la lanceta.
La invención se define en las
reivindicaciones.
Las formas de realización de la presente
invención se refieren a productos de asistencia médica y a
procedimientos para obtener fluidos corporales para análisis
químicos. Más particularmente, las formas de realización de la
invención se refieren a dispositivos y a procedimientos para
perforar la piel (puncionar) utilizando una lanceta accionada de
forma eléctrica provista de parámetros de lanceta relativos al
usuario que se pueden definir, como el desplazamiento de lanceta,
la velocidad de la incisión, la retracción, la aceleración y el
tiempo de permanencia en el tejido. Un dispositivo con las
características de la invención puede compensar los cambios a largo
plazo en la fisiología de la piel, la función nerviosa, y la
perfusión vascular periférica, como ocurre en las personas
diabéticas, así como la variación diurna en las propiedades tensiles
de la piel. De forma alternativa, un dispositivo con las
características de la invención puede compensar las diferencias de
la piel entre poblaciones que difieren ampliamente como los
pacientes pediátricos y geriátricos.
Una forma de realización de la invención se
refiere a un dispositivo de punción que controla el avance y la
retracción de una lanceta, mediante la observación de la posición de
dicha lanceta en conjunción con una retroalimentación de control
para modular el accionador de lanceta para que siga un perfil
predeterminado.
Los objetivos, ventajas y características de la
presente invención se pondrán más claramente de manifiesto a partir
de la descripción detallada siguiente, leída conjuntamente con el
dibujo adjunto en el que: las figuras 1A y 2A ilustran el perfil de
desplazamiento en el tiempo de un sistema resorte/masa harmónico y
una lanceta controlada.
Las figuras 1B y 2B ilustran los perfiles de
velocidad respecto al tiempo de un sistema resorte/masa harmónico y
una lanceta controlada.
La figura 3 ilustra un actuador controlado que
utiliza un actuador electromagnético para accionar la lanceta.
La figura 4 es un diagrama de flujo que ilustra
un bucle de retroalimentación controlada.
La figura 5 es un gráfico de fuerza versus
tiempo durante el avance y la retracción de la lanceta, que muestra
las fases características del ciclo de punción.
El dispositivo de punción se define generalmente
como un dispositivo autónomo para puncionar la piel con el fin de
obtener una muestra de fluido sanguíneo. Los dispositivos de punción
típicamente son desechables y reutilizables en su totalidad, o
parcialmente. Por ejemplo, algunos dispositivos de punción se
desechan como material con riesgo biológico después de un uso.
Otros dispositivos de punción únicamente desechan las partes que
entran en contacto con la piel.
La lanceta generalmente se define como cualquier
elemento afilado o romo utilizado para puncionar la piel, con el
fin de cortar vasos sanguíneos y permitir que la sangre fluya a la
superficie de la piel. La lanceta presenta determinados parámetros,
como un diámetro para definir la zona en sección transversal del
elemento, y una geometría para definir la forma del extremo de la
lanceta distal o frontal del elemento.
El accionador de la lanceta generalmente se
define como cualquier medio para controlar el avance y la retracción
de la lanceta. Algunos ejemplos de accionadores de lanceta pueden
incluir accionadores accionados mediante resorte, accionadores
electromagnéticos y accionadores piezoeléctricos. Algunos ejemplos
de accionadores electromagnéticos incluyen solenoides, motores de
inducción lineales, y motores de reluctancia lineales.
El bucle de retroalimentación generalmente se
define como un bucle de control de la retroalimentación en el que
se recoge información relativa al comportamiento a tiempo real de la
lanceta (como la posición relativa de la lanceta, el ritmo y la
dirección del movimiento de la lanceta, la resistencia al movimiento
de la lanceta, etc.) y se utiliza para modular la potencia de
accionamiento aplicada a dicha lanceta.
El procesador generalmente se define como un
procesador digital de alta velocidad que contiene capacidades de
memoria y cálculo. Dicho procesador se utiliza para modular el
accionador de la lanceta. Modular generalmente se refiere al
control del perfil de la lanceta.
El perfil generalmente se define como un
desplazamiento, velocidad o aceleración versus una tabla o gráfica
de tiempo.
Típicamente, la lanceta y el accionador de
lanceta están configurados de manera que la velocidad de la lanceta
sea elevada en el momento del primer contacto con la piel,
desacelere a cero en la profundidad de penetración predeterminada,
y se retraiga inmediatamente de la piel, alejándose aproximadamente
a la misma velocidad que ha entrado. La energía requerida para el
accionamiento de la lanceta inicialmente se almacena como energía
potencial, al igual que en los accionadores mencionados
anteriormente. Durante el ciclo de punción, la energía almacenada
se transforma en la energía cinética de la lanceta, que a
continuación se transforma en energía potencial en el pico de la
trayectoria, y se vuelve a transformar inmediatamente en energía
cinética mediante el mecanismo de retracción. Las velocidades de
accionamiento y retracción son similares, aunque de signo opuesto.
Los dispositivos que utilizan procedimientos de accionamiento de
resorte o leva presentan un desplazamiento de accionamiento y un
perfil de velocidad en el avance y la retracción de la lanceta
simétricos. En la mayoría de los dispositivos de lanceta
disponibles, una vez que se ha iniciado la punción, la energía
almacenada determina el perfil de velocidad hasta que se disipa la
energía. También se han descrito los procedimientos de corte
ayudados por piezoeléctricos, sin embargo, el mecanismo de inicio de
punción está accionado mediante resorte y no se describe
retroalimentación para controlar el movimiento de la lanceta. Las
variaciones en las propiedades de la piel requieren el control del
impacto, de la velocidad de retracción, y del tiempo de permanencia
de la lanceta en el tejido.
Se consiguen ventajas teniendo en cuenta que el
tiempo de permanencia del tejido está relacionado con la cantidad
de deformación de la piel cuando la lanceta intenta puncionar la
superficie de la piel, así como la variación en la deformación de
la piel entre un paciente y otro dependiendo de la hidratación de la
misma con respecto al tiempo de permanencia y a la necesidad de
conseguir por lo menos 100 micras de profundidad de la piel para
obtener una muestra de sangre satisfactoria.
Se puede conseguir la reducción del dolor tanto
mediante la rápida velocidad de corte de la lanceta, como gracias
al peso ligero de la lanceta propuesta. El corte rápido minimiza las
ondas de choque producidas cuando la lanceta golpea la piel, además
de comprimir la piel para un corte eficiente. Debido a la masa tan
ligera de la lanceta y a la falta de un tope mecánico, se
transfiere al dedo una energía insustancial o no vibratoria durante
el corte.
Los dispositivos de punción, como los
dispositivos accionados mediante resorte y leva, típicamente cuentan
con una razón de satisfacción de 70-80% en la
obtención de una gota de sangre, dado que algunos casos de punción
no son satisfactorios. La razón de satisfacción depende de si se
alcanzan las vénulas y los capilares sanguíneos, de los que se
obtienen la muestra de sangre. Debido a la variación en el grosor y
en la hidratación de la piel, algunas pieles se deforman más antes
de que se inicie el corte y, así, la profundidad de penetración
real será menor, por lo que se cortarán menos capilares y vénulas.
Un mecanismo de retroalimentación electrónico obtiene una medición
precisa de la resistencia de la piel y, por lo tanto, de la
penetración de la piel y, así, mejora directamente la razón de
satisfacción de la obtención de sangre.
La obtención de sangre espontánea tiene lugar
cuando la sangre de los vasos cortados fluye por la herida a la
superficie de la piel, en la que se puede recoger y analizar. Los
parámetros de elasticidad del tejido pueden forzar la herida a
cerrarse detrás de la lanceta en retracción, evitando que la sangre
llegue a la superficie. Sin embargo, si la lanceta se mantuviese
antes de su retracción, y/o se retrajese lentamente de la herida,
manteniendo así la herida abierta, la sangre podría fluir del canal
patente, según se describe en la solicitud WO/2002/00461 en
trámite.
La capacidad de controlar la velocidad de la
entrada y la salida de la lanceta en la herida resulta de suma
importancia, dado que permite que el dispositivo compense los
cambios en el grosor de la piel y en las variaciones en la
hidratación de ésta, para conseguir una generación de sangre
espontánea con una razón de satisfacción máxima, al mismo tiempo
que se minimiza el dolor. Esto se lleva a cabo teniendo en cuenta la
deformación de la piel para conseguir un tiempo de permanencia en
el tejido y una profundidad de penetración deseables.
Por lo tanto, dicha capacidad para controlar la
velocidad y la profundidad de penetración requiere un mecanismo de
accionamiento en el que la retroalimentación resulte una parte
integrada del control de accionamiento. Un ejemplo de dicho
accionador es el diseño del actuador electromagnético según se
describe en la solicitud en trámite US
2004-0083686. Dichos accionadores pueden controlar
tanto lancetas metálicas como poliméricas. El control dinámico de
dicho accionador se muestra en la figura 2A, que ilustra el perfil
de desplazamiento controlado y en la figura 2B, que ilustra el
perfil de velocidad controlada. Éstos se comparan con las figuras
1A y 1B que ilustran los perfiles de desplazamiento y velocidad,
respectivamente, de un sistema resorte/masa harmónico.
De acuerdo con esto, resulta ventajoso controlar
el desplazamiento de la velocidad y la aceleración de la lanceta en
varias etapas del ciclo de punción. Dicho control incrementa la
razón de satisfacción en la obtención de un volumen de muestra
sanguínea aceptable, así como la capacidad para obtener una muestra
de sangre espontánea, y reduce el dolor percibido por el paciente
durante el procedimiento de punción. Se consigue reducir el dolor
gracias a la entrada rápida de la lanceta en el tejido. La velocidad
de la lanceta reducida con un incremento en el tiempo de
permanencia en el tejido en un punto en el que la lanceta
intersecciona las vénulas y las redes capilares, permite la salida
de la sangre, facilitando la salida del flujo sin restricciones en
el canal de salida. La retracción de la lanceta a una velocidad
reducida después de la sección de las vénulas/redes capilares,
permite que la sangre fluya por la herida y libremente a la
superficie, utilizando así la lanceta para mantener el canal
abierto durante la retracción. La retracción de la lanceta a baja
velocidad cerca del jirón de la herida evita que dicha entrada de
la herida selle el canal. De este modo, la capacidad de ralentizar
la retracción de la lanceta contribuye directamente a incrementar la
razón de satisfacción de obtención de sangre. Un incremento de la
razón de satisfacción en la obtención de una muestra próximo al 100%
se considera un pre-requisito esencial para
combinar muestreo/toma de muestras en un módulo de toma de muestras
integrado (por ejemplo, un módulo de toma de muestras de glucosa
integrado que incorpore una tira de análisis de glucosa).
A continuación, se hará referencia a las formas
de realización a título de ejemplo de la presente invención. En la
primera forma de realización, un dispositivo de punción contiene una
lanceta y un accionador de lanceta. La lanceta y el accionador de
lanceta están configurados de manera que el control de la
retroalimentación se base en el desplazamiento, la velocidad, o la
aceleración de la lanceta. La información de control de
retroalimentación relacionada con el paso de lanceta a tiempo real
retorna a un procesador que regula la energía del accionador de
lanceta, controlando así la lanceta de forma precisa en su avance y
retracción. El accionador de lanceta se puede accionar mediante
corriente eléctrica, que incluye corriente continua y corriente
alterna. La figura 3 muestra un accionador de lanceta del tipo
electromagnético que puede accionar un núcleo de hierro montado en
el conjunto de lanceta, utilizando una fuente de energía de
corriente continua (CC). El solenoide se divide en tres bobinas
separadas a lo largo del paso de la lanceta, dos bobinas finales y
una bobina intermedia. Se aplica corriente continua a dichas
bobinas para el avance y la retracción de la lanceta. Se utilizan
las bobinas en pares para retirar el núcleo de hierro en el
solenoide. Cuando se pone en marcha una de las bobinas, se controla
la corriente inducida en la bobina adyacente correspondiente. La
potencia de dicha corriente inducida está relacionada con el grado
de acoplamiento magnético proporcionado por el núcleo de hierro, y
se puede utilizar para deducir la posición de dicho núcleo. Después
de un periodo de tiempo, se desconecta el voltaje de accionamiento,
permitiendo el reposo de las bobinas, y a continuación se repite el
ciclo. El grado de acoplamiento magnético entre las bobinas se
convierte electrónicamente en un voltaje CC proporcional que se
suministra a un convertidor analógico-digital.
Seguidamente, se procesa la señal de posición digitalizada y se
compara con una posición "nominal" deseada mediante una unidad
central de procesamiento (CPU). Dicha CPU utiliza el error entre
las posiciones reales y nominales para establecer el nivel y/o la
longitud del siguiente pulso de potencia a las bobinas
solenoides.
Haciendo referencia a la figura 3, la carcasa
estacionaria (40) contiene el solenoide, cuya primera bobina (52)
está separada mediante un separador (50) permeable magnéticamente de
la bobina adyacente. La carcasa (40) está realizada a partir de un
material permeable magnéticamente, y se monta un separador permeable
magnéticamente en la parte exterior de la primera bobina. Los
separadores y la carcasa forman un circuito magnético que enfoca el
campo magnético producido por la bobina entre los bordes del
diámetro interior de los separadores. Sucede lo mismo en cada una
de las otras bobinas, la carcasa y sus separadores. La conducción de
guiado interior (48) aísla la lanceta (42) y el núcleo de hierro
(46) de las bobinas solenoides (52). La lanceta (42) y el núcleo de
hierro (46) se centran mediante la guía de lanceta (44). La lanceta
(42) se hace avanzar y retraer alternando la corriente entre la
primera bobina (52), la bobina intermedia (que no se muestra), y la
tercera bobina (que no se muestra), de forma individual o
combinadas entre sí, para hacer avanzar o retraer el núcleo de
hierro (46). La guía de lanceta (44) también sirve como tope para el
núcleo de hierro (46) montado a la lanceta (42).
En otra forma de realización, el solenoide
comprende tres bobinas que consisten en una bobina de accionamiento
central flanqueada por bobinas de detección simétricas construidas
en el conjunto de accionamiento, de manera que rodeen la zona de
accionamiento con la zona centrada en la bobina intermedia a media
carrera. Cuando se aplica un pulso de corriente a la bobina
central, se inducen voltajes en las bobinas de detección adyacentes.
Si dichas bobinas de detección están conectadas de manera que sus
voltajes inducidos sean opuestos entre sí, la señal resultante será
positiva para la deflexión desde la media carrera en una dirección,
negativa en la otra dirección y cero en media carrera. Esta técnica
de medición se utiliza comúnmente en los transformadores
diferenciales de variable lineal (LVDT). La posición de la lanceta
se determina mediante la medición de la comparación eléctrica entre
las dos bobinas de detección.
En otra forma de realización, el bucle de
retroalimentación utiliza un módulo transductor LED/foto disponible
comercialmente, como por ejemplo el OPB703 (fabricado por Optek
Technology, Inc., 1215 W. Crosby Road, Carrollton, Texas, 75006
(972) 323-2200) para determinar la distancia entre
el módulo fijado en la carcasa estacionaria y una superficie u
objetivo reflector montado en el conjunto de lanceta. El LED actúa
como un emisor de luz para enviar rayos de luz a la superficie
reflectora que, a su vez, refleja la luz hacia el fototransductor,
que actúa como un detector de luz. Las distancias mayores de 4 mm o
similares se determinan mediante la medición de la intensidad de la
luz reflejada por dicho fototransductor.
En otra forma de realización, el bucle de
retroalimentación utiliza una zona permeable magnéticamente en el
propio eje de la lanceta, como el núcleo de un transformador de
diferencial de variable lineal (LVDT). Se puede crear una zona
permeable mediante el recocido selectivo de una parte del eje de la
lanceta, o incluyendo un componente en el conjunto de lanceta, como
ferrita, con una permeabilidad magnética suficiente como para
permitir el acoplamiento entre bobinas de detección adyacentes. El
tamaño de la bobina, el número de espiras, la corriente de
accionamiento, la amplificación de señal, así como el hueco de aire
en la zona permeable se especifican en el proceso de diseño.
En otra forma de realización, el control de
retroalimentación suministra un accionador piezoeléctrico
sobreponiendo una oscilación de alta frecuencia en el perfil de
desplazamiento básico. Dicho accionador piezoeléctrico proporciona
una eficiencia de corte mejorada y reduce el dolor, permitiendo que
la lanceta "corte" el tejido en su camino o destruya las
células con energía de cavitación generada por la alta frecuencia de
vibración del borde de avance de la lanceta. La energía de
accionamiento al accionamiento piezoeléctrico se controla para un
desplazamiento de la impedancia cuando el dispositivo interactúa
con el tejido objetivo. La medición de la fuerza resultante,
conjuntamente con la masa conocida de la lanceta, se utiliza para
determinar la aceleración, la velocidad y la posición de la
lanceta.
La figura 4 muestra el funcionamiento del bucle
de retroalimentación que utiliza el procesador. Dicho procesador
(60) almacena unos perfiles (62) en una memoria no volátil. Un
usuario introduce información (64) acerca de las circunstancias
deseadas para el momento de punción. El procesador (60) selecciona
un perfil (62) entre un conjunto de perfiles alternativos que han
sido preprogramados en el procesador (60) basándose en el
funcionamiento de un dispositivo típico determinado mediante
ensayos en la fábrica. El procesador (60) se puede personalizar,
calibrando o modificando el perfil según la introducción de
información (64) adicional del usuario. Una vez que el procesador
(60) ha seleccionado y personalizado el perfil, éste está listo para
modular la potencia de la fuente de energía (66) al accionador de
lanceta (68) a través de un amplificador (70). El procesador (60)
mide la ubicación de la lanceta (72) utilizando un mecanismo de
detección de posición (74) a través de un convertidor
analógico-digital (76). En las formas de realización
anteriores se describen ejemplos de mecanismos de detección de
posición. El procesador (60) calcula el movimiento de la lanceta
comparando el perfil a tiempo real de dicha lanceta con el perfil
predeterminado. El procesador (60) modula la potencia al accionador
de lanceta (68) a través de un generador de señal (78) que controla
el amplificador (70) de manera que el perfil a tiempo real de dicha
lanceta no exceda el perfil predeterminado por encima de un límite
de error preestablecido. El límite de error es la precisión en el
control de la lanceta.
\newpage
Después de la punción, el procesador (60)
permite que el usuario clasifique los resultados de la punción. El
procesador (60) almacena dichos resultados y crea una base de datos
(80) para el usuario en particular. utilizando dicha base de datos
(80), el procesador (60) calcula las particularidades del perfil
como el grado de analgesia, la razón de satisfacción, y el volumen
de sangre para los distintos perfiles (62) dependiendo de la
información introducida por el usuario (64) para mejorar el perfil
para el usuario individual para ciclos de punción posteriores.
Estas particularidades del perfil dependen de las fases
características del avance y la retracción de la lanceta. El
procesador (60) utiliza dichos cálculos para mejorar los perfiles
(62) de cada usuario. Además de la información introducida por el
usuario (64) un reloj interior permite el almacenaje en la base de
datos (80) de información como la hora del día para generar un
registro de la hora de la punción y el tiempo entre punciones para
anticipar las necesidades diarias del usuario. La base de datos
almacena información y estadísticas de cada usuario y cada perfil
que el usuario en concreto utiliza.
Además de variar los perfiles, el procesador
calcula el diámetro y la geometría adecuados de la lanceta,
necesarios para obtener el volumen de sangre requerido por el
usuario. Por ejemplo, si el usuario requiere un volumen de sangre
entre 1 y 5 microlitros, el procesador selecciona un diámetro de
lanceta de 200 micras para conseguir dicho resultado. Se almacena
en el procesador tanto el diámetro como la geometría de cada clase
de lanceta, para corresponder con los límites superior e inferior
de volumen de sangre que se puede obtener dependiendo de los
perfiles de desplazamiento y velocidad predeterminados.
El dispositivo de punción puede solicitar al
usuario información al inicio y al final de la punción para
adecuarse con mayor exactitud al mismo. El objetivo es cambiar a un
perfil diferente o modificar un perfil ya existente. Una vez
establecido el perfil, se hace variar la fuerza que acciona la
lanceta durante el avance y la retracción para seguir dicho perfil.
El procedimiento de punción utilizando el dispositivo de punción
comprende la selección de un perfil, la punción, determinando las
particularidades del perfil de punción para cada fase característica
del ciclo de punción, y la mejora para las punciones
posteriores.
La figura 5 muestra las fases características de
avance y retracción de la lanceta en un gráfico de fuerza versus
tiempo que ilustra la fuerza ejercida por el accionador de lanceta
sobre la lanceta para conseguir el perfil de desplazamiento y
velocidad deseado. Las fases características son la fase de
introducción de la lanceta A a C en la que dicha lanceta avanza
longitudinalmente en la piel, la fase D de descanso de la lanceta
en la que dicha lanceta finaliza su movimiento longitudinal
alcanzando su profundidad máxima y quedando relativamente
estacionaria, y la fase de retracción E a G de la lanceta en la que
dicha lanceta se retrae longitudinalmente fuera la piel. La
duración de la fase de retracción E a G es mayor que la duración de
la fase de introducción de la lanceta A a C que, a su vez, es mayor
que la duración de la fase de descanso de la lanceta D.
La fase de introducción también comprende una
fase de puesta en marcha de lanceta anterior a A, cuando la lanceta
se mueve longitudinalmente en el aire hacia la piel, una fase de
contacto con el tejido al inicio de A cuando el extremo distal de
la lanceta realiza el contacto inicial con la piel, una fase de
deformación A del tejido cuando la piel se dobla dependiendo de sus
propiedades de elasticidad, relacionadas con la hidratación y el
grosor, una fase de punción del tejido que comprende cuando la
lanceta golpea el punto de inflexión en la piel y empieza a cortar
la piel B y la lanceta continúa cortando la piel C. La fase de
descanso D de la lanceta es el límite de penetración de dicha
lanceta en la piel. El dolor se reduce minimizando la duración de
la fase de introducción A a C de la lanceta de manera que se realiza
una incisión rápida a una profundidad de penetración determinada,
sin tener en cuenta la duración de la fase de deformación A y el
corte del punto de inflexión B que variará de un usuario a otro. La
razón de satisfacción se incrementa con la medición de la
profundidad de penetración exacta desde el punto de inflexión B
hasta el límite de penetración en la fase de descanso D de la
lanceta. Esta medición permite que la lanceta siempre, o por lo
menos de forma fiable, golpee los lechos capilares que se
encuentran a una distancia conocida debajo de la superficie de la
piel.
La fase de retracción de la lanceta también
comprende una fase de retracción primaria E cuando la piel empuja
la lanceta hacia el exterior de la herida, una fase de retracción
secundaria F cuando la lanceta empieza a retirarse y estira en la
dirección opuesta la piel, y una fase de salida G de la lanceta
cuando dicha lanceta sale de la piel. La retracción primaria es el
resultado de ejercer una fuerza decreciente para sacar la lanceta
de la piel a medida que la lanceta se aleja del dedo. La retracción
secundaria es el resultado de ejercer una fuerza en la dirección
opuesta a la retirada de la lanceta. Es necesario el control para
mantener la herida abierta mientas fluye la sangre de dicha herida.
Se incrementa el volumen de sangre utilizando una velocidad
uniforme para retraer la lanceta durante la fase de retracción E a
G, independientemente de la fuerza necesaria para la fase de
retracción primaria E o la fase de retracción secundaria F, pudiendo
cualquiera de las mismas variar entre un usuario y otro dependiendo
de las propiedades de la piel del mismo.
Para los expertos en la materia resultarán
evidentes otras formas de realización de la invención tras
considerar los requisitos y la práctica de la presente invención
descrita en la presente memoria.
Se pretende que la memoria y los ejemplos sean
considerados únicamente a título de ejemplo.
Claims (19)
1. Dispositivo de punción que comprende
una lanceta (54) que comprende un eje provisto
de un extremo de accionamiento proximal y un extremo de lanceta
distal;
un accionador de lanceta (52) acoplado a dicha
lanceta para el desplazamiento longitudinal de dicha lanceta;
un mecanismo de detección de la posición de la
lanceta (74) y
un controlador de lanceta (60) acoplado a dicho
accionador de lanceta y dicho mecanismo de detección de posición de
lanceta, pudiendo funcionar dicho controlador de lanceta para medir
la localización de la lanceta (72) que utiliza el mecanismo de
detección de posición (74) y para calcular el movimiento de la
lanceta, comprendiendo dicho controlador de lanceta un bucle de
retroalimentación para controlar el desplazamiento longitudinal de
dicha lanceta y para modular el accionador de lanceta con el fin de
proporcionar un perfil de punción del tejido predeterminado en
términos de un desplazamiento, velocidad o aceleración con respecto
a tiempo, con las fases características para el avance y la
retracción de la lanceta.
2. Dispositivo de punción según la
reivindicación 1, en el que dicho accionador de lanceta comprende un
solenoide.
3. Dispositivo de punción según la
reivindicación 2, en el que dicho solenoide acciona la lanceta con
corriente eléctrica.
4. Dispositivo de punción según la
reivindicación 3, en el que dicho controlador de lanceta comprende
unos segmentos de bobina adicionales dispuestos adyacentes a dicho
solenoide para controlar el desplazamiento de la lanceta.
5. Dispositivo de punción según la
reivindicación 1, en el que dicho accionador de lanceta comprende
unos medios para hacer oscilar la lanceta con el fin de mejorar la
capacidad de corte de la lanceta.
6. Dispositivo de punción según la
reivindicación 5, en el que dichos medios de oscilación comprenden
un accionador piezoeléctrico.
7. Dispositivo de punción según la
reivindicación 6, en el que dicho controlador de lanceta varía de
forma controlada dicho perfil de tejido de punción de tejido como
una función de cambios de impedancia detectados de dicho accionador
piezoeléctrico como resultado de dicha interacción de la lanceta con
dicho tejido.
8. Dispositivo de punción según la
reivindicación 5, en el que dicho controlador de lanceta comprende
unos medios para detectar un cambio en la presión de punción para
determinar el desplazamiento de la lanceta.
9. Dispositivo de punción según cualquiera de
las reivindicaciones anteriores, en el que dicho controlador de
lanceta comprende un procesador para modular el accionador de
lanceta.
10. Dispositivo de punción según la
reivindicación 9, en el que dicho procesador comprende memoria para
el almacenamiento y la recuperación de un conjunto de perfiles de
punción alternativos que el procesador utiliza para modular el
accionador de lanceta.
11. Dispositivo de punción según la
reivindicación 10, en el que un usuario de dicho dispositivo de
punción selecciona el perfil deseado de entre dicho conjunto de
perfiles alternativos para modular la lanceta.
12. Dispositivo de punción según cualquiera de
las reivindicaciones 9 a 11, en el que dicho procesador optimiza
dichas fases de dicho perfil de punción del tejido dependiendo de la
información introducida por el usuario de dicho dispositivo de
punción.
13. Dispositivo de punción según cualquiera de
las reivindicaciones 9 a 12, en el que dicho procesador modula el
accionador de lanceta comparando un perfil a tiempo real de la
lanceta con el perfil y manteniendo un límite de error
predeterminado entre el perfil a tiempo real y el perfil.
14. Dispositivo de punción según cualquiera de
las reivindicaciones 9 a 13, en el que dicho procesador comprende
una base de datos para el usuario.
15. Dispositivo de punción según la
reivindicación 14, en el que dicha base de datos permite el cálculo
de las estadísticas para un perfil.
16. Dispositivo de punción según cualquiera de
las reivindicaciones 9 a 15, en el que dicho procesador comprende
un reloj interior que une la punción con un registro de la hora.
17. Dispositivo de punción según cualquiera de
las reivindicaciones 9 a 16, en el que dicho procesador calcula un
diámetro y una geometría de lanceta adecuados para recoger un
volumen de sangre requerido por el usuario.
18. Dispositivo de punción según cualquiera de
las reivindicaciones 1 a 17, en el que dicho mecanismo de detección
de posición comprende un detector de luz y un emisor de luz para
controlar la posición relativa de dicha lanceta, comprendiendo
además dicha lanceta una superficie reflectora en dicho extremo
proximal, de manera que dicho emisor de luz emita luz para que
dicha luz se refleje desde dicha superficie reflectora hasta dicho
detector.
19. Dispositivo de punción según cualquiera de
las reivindicaciones 1 a 17, en el que dicho mecanismo de detección
de posición comprende un detector electromagnético para controlar la
posición relativa de por lo menos una zona permeable magnéticamente
dispuesta en una zona de dicho eje, comprendiendo dicho detector por
lo menos un solenoide.
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US (2) | US7316700B2 (es) |
EP (1) | EP1404233B1 (es) |
JP (2) | JP4209767B2 (es) |
AT (1) | ATE450210T1 (es) |
AU (1) | AU2002315177A1 (es) |
CA (1) | CA2448902C (es) |
DE (1) | DE60234598D1 (es) |
ES (1) | ES2336081T3 (es) |
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-
2002
- 2002-06-12 US US10/220,828 patent/US7316700B2/en not_active Expired - Fee Related
- 2002-06-12 AT AT02742123T patent/ATE450210T1/de not_active IP Right Cessation
- 2002-06-12 EP EP02742123A patent/EP1404233B1/en not_active Expired - Lifetime
- 2002-06-12 JP JP2003503081A patent/JP4209767B2/ja not_active Expired - Fee Related
- 2002-06-12 WO PCT/US2002/019053 patent/WO2002100251A2/en active Application Filing
- 2002-06-12 DE DE60234598T patent/DE60234598D1/de not_active Expired - Fee Related
- 2002-06-12 ES ES02742123T patent/ES2336081T3/es not_active Expired - Lifetime
- 2002-06-12 CA CA2448902A patent/CA2448902C/en not_active Expired - Fee Related
- 2002-06-12 AU AU2002315177A patent/AU2002315177A1/en not_active Abandoned
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2007
- 2007-05-03 US US11/744,063 patent/US7988645B2/en not_active Expired - Fee Related
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2008
- 2008-09-09 JP JP2008230926A patent/JP5134475B2/ja not_active Expired - Fee Related
Also Published As
Publication number | Publication date |
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ATE450210T1 (de) | 2009-12-15 |
US20030233112A1 (en) | 2003-12-18 |
EP1404233A2 (en) | 2004-04-07 |
US7316700B2 (en) | 2008-01-08 |
US20070239189A1 (en) | 2007-10-11 |
US7988645B2 (en) | 2011-08-02 |
DE60234598D1 (de) | 2010-01-14 |
JP2008289939A (ja) | 2008-12-04 |
EP1404233B1 (en) | 2009-12-02 |
WO2002100251A3 (en) | 2003-08-21 |
WO2002100251A2 (en) | 2002-12-19 |
EP1404233A4 (en) | 2007-05-30 |
AU2002315177A1 (en) | 2002-12-23 |
CA2448902C (en) | 2010-09-07 |
JP5134475B2 (ja) | 2013-01-30 |
CA2448902A1 (en) | 2002-12-19 |
JP4209767B2 (ja) | 2009-01-14 |
JP2005504564A (ja) | 2005-02-17 |
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