ES2574636T3 - Métodos y dispositivo para monitorizar la integridad de una conexión fluida - Google Patents

Métodos y dispositivo para monitorizar la integridad de una conexión fluida Download PDF

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ES2574636T3
ES2574636T3 ES09769023.4T ES09769023T ES2574636T3 ES 2574636 T3 ES2574636 T3 ES 2574636T3 ES 09769023 T ES09769023 T ES 09769023T ES 2574636 T3 ES2574636 T3 ES 2574636T3
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signal
fluid
measurement signal
integrity
pulse generator
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Thomas Hertz
Kristian Solem
Anders Roslund
Jan Sternby
Martin Furmanski
Bo Olde
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Gambro Lundia AB
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Gambro Lundia AB
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/34—Filtering material out of the blood by passing it through a membrane, i.e. hemofiltration or diafiltration
    • A61M1/3413—Diafiltration
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/36—Other treatment of blood in a by-pass of the natural circulatory system, e.g. temperature adaptation, irradiation ; Extra-corporeal blood circuits
    • A61M1/3621—Extra-corporeal blood circuits
    • A61M1/3653—Interfaces between patient blood circulation and extra-corporal blood circuit
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/34—Filtering material out of the blood by passing it through a membrane, i.e. hemofiltration or diafiltration
    • A61M1/342—Adding solutions to the blood, e.g. substitution solutions
    • A61M1/3441—Substitution rate control as a function of the ultrafiltration rate
    • A61M1/3444—Substitution rate control as a function of the ultrafiltration rate in which the collected ultra-filtrate expels an equal volume of substitution fluid from a reservoir
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/34—Filtering material out of the blood by passing it through a membrane, i.e. hemofiltration or diafiltration
    • A61M1/342—Adding solutions to the blood, e.g. substitution solutions
    • A61M1/3441—Substitution rate control as a function of the ultrafiltration rate
    • A61M1/3448—Substitution rate control as a function of the ultrafiltration rate by mechanically linked pumps in both ultra-filtrate and substitution flow line
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/36—Other treatment of blood in a by-pass of the natural circulatory system, e.g. temperature adaptation, irradiation ; Extra-corporeal blood circuits
    • A61M1/3601—Extra-corporeal circuits in which the blood fluid passes more than once through the treatment unit
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/36—Other treatment of blood in a by-pass of the natural circulatory system, e.g. temperature adaptation, irradiation ; Extra-corporeal blood circuits
    • A61M1/3621—Extra-corporeal blood circuits
    • A61M1/3653—Interfaces between patient blood circulation and extra-corporal blood circuit
    • A61M1/3656—Monitoring patency or flow at connection sites; Detecting disconnections
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/36—Other treatment of blood in a by-pass of the natural circulatory system, e.g. temperature adaptation, irradiation ; Extra-corporeal blood circuits
    • A61M1/3621—Extra-corporeal blood circuits
    • A61M1/3653—Interfaces between patient blood circulation and extra-corporal blood circuit
    • A61M1/3659—Cannulae pertaining to extracorporeal circulation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/36—Other treatment of blood in a by-pass of the natural circulatory system, e.g. temperature adaptation, irradiation ; Extra-corporeal blood circuits
    • A61M1/3621—Extra-corporeal blood circuits
    • A61M1/3653—Interfaces between patient blood circulation and extra-corporal blood circuit
    • A61M1/3659—Cannulae pertaining to extracorporeal circulation
    • A61M1/3661—Cannulae pertaining to extracorporeal circulation for haemodialysis
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/36—Other treatment of blood in a by-pass of the natural circulatory system, e.g. temperature adaptation, irradiation ; Extra-corporeal blood circuits
    • A61M1/38—Removing constituents from donor blood and storing or returning remainder to body, e.g. for transfusion
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01L—MEASURING FORCE, STRESS, TORQUE, WORK, MECHANICAL POWER, MECHANICAL EFFICIENCY, OR FLUID PRESSURE
    • G01L27/00—Testing or calibrating of apparatus for measuring fluid pressure
    • G01L27/002—Calibrating, i.e. establishing true relation between transducer output value and value to be measured, zeroing, linearising or span error determination
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01M—TESTING STATIC OR DYNAMIC BALANCE OF MACHINES OR STRUCTURES; TESTING OF STRUCTURES OR APPARATUS, NOT OTHERWISE PROVIDED FOR
    • G01M3/00—Investigating fluid-tightness of structures
    • G01M3/02—Investigating fluid-tightness of structures by using fluid or vacuum
    • G01M3/26—Investigating fluid-tightness of structures by using fluid or vacuum by measuring rate of loss or gain of fluid, e.g. by pressure-responsive devices, by flow detectors
    • G01M3/28—Investigating fluid-tightness of structures by using fluid or vacuum by measuring rate of loss or gain of fluid, e.g. by pressure-responsive devices, by flow detectors for pipes, cables or tubes; for pipe joints or seals; for valves ; for welds
    • G01M3/2807—Investigating fluid-tightness of structures by using fluid or vacuum by measuring rate of loss or gain of fluid, e.g. by pressure-responsive devices, by flow detectors for pipes, cables or tubes; for pipe joints or seals; for valves ; for welds for pipes
    • G01M3/2815—Investigating fluid-tightness of structures by using fluid or vacuum by measuring rate of loss or gain of fluid, e.g. by pressure-responsive devices, by flow detectors for pipes, cables or tubes; for pipe joints or seals; for valves ; for welds for pipes using pressure measurements
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01M—TESTING STATIC OR DYNAMIC BALANCE OF MACHINES OR STRUCTURES; TESTING OF STRUCTURES OR APPARATUS, NOT OTHERWISE PROVIDED FOR
    • G01M3/00—Investigating fluid-tightness of structures
    • G01M3/02—Investigating fluid-tightness of structures by using fluid or vacuum
    • G01M3/26—Investigating fluid-tightness of structures by using fluid or vacuum by measuring rate of loss or gain of fluid, e.g. by pressure-responsive devices, by flow detectors
    • G01M3/28—Investigating fluid-tightness of structures by using fluid or vacuum by measuring rate of loss or gain of fluid, e.g. by pressure-responsive devices, by flow detectors for pipes, cables or tubes; for pipe joints or seals; for valves ; for welds
    • G01M3/2846—Investigating fluid-tightness of structures by using fluid or vacuum by measuring rate of loss or gain of fluid, e.g. by pressure-responsive devices, by flow detectors for pipes, cables or tubes; for pipe joints or seals; for valves ; for welds for tubes
    • 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
    • G01N33/487—Physical analysis of biological material of liquid biological material
    • G01N33/49—Blood
    • G—PHYSICS
    • G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16Z—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS, NOT OTHERWISE PROVIDED FOR
    • G16Z99/00—Subject matter not provided for in other main groups of this subclass

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  • Health & Medical Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Vascular Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Hematology (AREA)
  • General Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Anesthesiology (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Physics & Mathematics (AREA)
  • Cardiology (AREA)
  • General Physics & Mathematics (AREA)
  • Chemical & Material Sciences (AREA)
  • Urology & Nephrology (AREA)
  • Analytical Chemistry (AREA)
  • Molecular Biology (AREA)
  • Food Science & Technology (AREA)
  • Medicinal Chemistry (AREA)
  • Ecology (AREA)
  • Biochemistry (AREA)
  • Biophysics (AREA)
  • Immunology (AREA)
  • Pathology (AREA)
  • External Artificial Organs (AREA)
  • Measuring Pulse, Heart Rate, Blood Pressure Or Blood Flow (AREA)
  • Measuring Fluid Pressure (AREA)

Abstract

Un dispositivo para monitorizar la integridad de una conexión fluida (C) entre primer y segundo sistemas que contienen fluido (S1, S2) basándose en al menos una señal de medición dependiente del tiempo procedente de al menos un sensor de presión (4a-4c) en el primer sistema que contiene fluido (S1), en el que el primer sistema que contiene fluido (S1) comprende un primer generador de pulsos (3), y el segundo sistema que contiene fluido (S2) comprende un segundo generador de pulsos (3'), y en el que dicho al menos un sensor de presión (4a-4c) está dispuesto para detectar primeros pulsos que se originan desde el primer generador de pulsos (3) y segundos pulsos que se originan desde el segundo generador de pulsos (3'), comprendiendo dicho dispositivo: un medio (28) para recibir dicha al menos una señal de medición; un medio (52) para procesar dicha al menos una señal de medición, o una señal de monitorización dependiente del tiempo obtenida a partir de ésta, para calcular un valor de parámetro indicativo de presencia o ausencia de los segundos pulsos; y un medio (52) para determinar la integridad de la conexión fluida (C) basándose al menos parcialmente en el valor de parámetro, caracterizado por que dicho dispositivo comprende además un medio (52) para obtener información de temporización indicativa de la temporización de los segundos pulsos en dicha al menos una señal de medición, y por que dicho medio (52) para procesar está configurado para calcular el valor de parámetro procesando dicha al menos una señal de medición, o la señal de monitorización obtenida a partir de ésta, basándose en la información de temporización.

Description

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señal en la figura 14(a) que falta en la figura 14(b). Las figuras 15(a) y 15(b) son vistas agrandadas de los picos de señal en las figuras 14(a) y 14(b), respectivamente, que muestran una clara diferencia entre los segmentos de señal filtrados con y sin un pulso cardiaco.
En una realización, el bloque de detección de latidos 53 está configurado para detectar la señal de latido basándose en una envolvente obtenida a partir del segmento de señal filtrado.
En una dicha variante, el bloque de detección de latidos 53 obtiene la envolvente extrayendo una serie de valores de pico del segmento de señal. Los valores de pico extraídos pueden venir dados extrayendo valores de señal de picos individuales identificados en el segmento de señal. Para mejorar la robustez del ruido, cada valor de pico extraído puede calcularse en su lugar como un promedio o suma de los valores de señal que forman cada pico en el segmento de señal, por ejemplo incluyendo valores de señal dentro del 10-25% del valor de pico o dentro de un intervalo de tiempo dado alrededor del valor de pico. La envolvente obtenida (serie de valores de pico) se procesa a continuación para el cálculo de un parámetro de evaluación. Las figuras 16(a) y 16(b) muestran series de valores de pico extraída de las figuras 15(a) y 15(b), respectivamente.
En otra variante, el bloque 53 obtiene la envolvente aplicando un filtro lineal invariable en el tiempo conocido como transformador de Hilbert al segmento de señal x. Esta operación da como resultado un segmento de señal transformado x , que es una versión desplazada 90° del segmento de señal. La envolvente b(n) puede obtenerse a continuación a partir de x con n siendo las diferentes posiciones en el segmento de señal.
Para eficiencia de procesamiento mejorada, el bloque 53 puede obtener una envolvente aproximada b̂ (n) a partir del segmento de señal x basándose en la relación
imagen18
La envolvente obtenida, sea aproximada o no, es procesada a continuación para el cálculo de un parámetro de evaluación.
En cualquier variante, la envolvente obtenida puede ser filtrada en filtro de paso bajo para eliminar adicionalmente el ruido de la envolvente adicional, antes de ser procesada para el cálculo del parámetro de evaluación.
En cualquier variante, el valor resultante del parámetro de evaluación puede compararse con un valor umbral para determinar presencia o ausencia de una señal de latido.
En un ejemplo, el parámetro de evaluación es la suma absoluta de derivadas de los valores de la envolvente, dada por:
imagen19
con b(n) siendo el valor de la envolvente en la posición n, y siendo N el número de valores en la envolvente.
La figura 17 ilustra un resultado de mover una ventana de 20 segundos sobre una señal de presión de 5 minutos, un segundo cada vez, y calcular la suma absoluta de las derivadas de sobre una envolvente obtenida para cada segmento de señal de 20 segundos. La curva superior se calcula para segmentos de señal filtrados que contienen una señal cardiaca, y la curva inferior se calcula para segmentos de señal filtrados sin una señal cardiaca. Claramente, puede definirse un valor umbral para distinguir entre la presencia y la ausencia de una señal cardiaca.
La curva superior muestra una forma de onda debido al hecho de que el segmento de señal contiene parte de un periodo de señal de latido completo. Por lo tanto, a lo largo del tiempo, los segmentos de señal contendrán diferentes partes de la señal de latido. Dado que el gradiente es pequeño alrededor de los picos y valles de la envolvente y más grandes entre ellos, la suma calculada de derivadas variará de forma correspondiente a lo largo del tiempo. Debe constatarse que, para una longitud dada (ventana temporal) del segmento de señal, la detectabilidad de los gradientes disminuirá con una diferencia de frecuencia menguante entre el corazón y la bomba sanguínea, dado que esto rebaja la frecuencia de latido y aplana la envolvente. Una ventana temporal más amplia mejorará la detectabilidad hasta el punto en el que la amplitud del latido se vuelve más pequeña que el ruido.
En otro ejemplo, el parámetro de evaluación es la varianza de los valores de la envolvente. La figura 18 es un gráfico que corresponde a la figura 17, pero que ilustra la varianza en función del tiempo, con (superior) y sin (inferior) una señal cardiaca. Claramente, puede definirse un valor umbral para distinguir entre la presencia y la ausencia de una señal cardiaca.
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Claims (1)

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ES09769023.4T 2008-06-26 2009-06-26 Métodos y dispositivo para monitorizar la integridad de una conexión fluida Active ES2574636T3 (es)

Applications Claiming Priority (5)

Application Number Priority Date Filing Date Title
US7577408P 2008-06-26 2008-06-26
US75774P 2008-06-26
SE0801517 2008-06-26
SE0801517 2008-06-26
PCT/EP2009/004640 WO2009156174A2 (en) 2008-06-26 2009-06-26 Methods and devices for monitoring the integrity or a fluid connection

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ES2574636T3 true ES2574636T3 (es) 2016-06-21

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ES09769023.4T Active ES2574636T3 (es) 2008-06-26 2009-06-26 Métodos y dispositivo para monitorizar la integridad de una conexión fluida
ES09769024.2T Active ES2558961T3 (es) 2008-06-26 2009-06-26 Método y dispositivo para el procesamiento de una señal de medida dependiente del tiempo

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US (4) US9442036B2 (es)
EP (3) EP3028725B1 (es)
JP (4) JP5529123B2 (es)
KR (2) KR101630887B1 (es)
CN (4) CN103948979B (es)
AU (2) AU2009262504B2 (es)
CA (2) CA2728875C (es)
EA (1) EA019772B1 (es)
ES (2) ES2574636T3 (es)
NZ (1) NZ590699A (es)
PL (2) PL2303356T3 (es)
WO (2) WO2009156175A2 (es)

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US20150019170A1 (en) 2015-01-15
EP2303357A2 (en) 2011-04-06
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