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WO2009146947A1 - Système de diagnostic - Google Patents

Système de diagnostic Download PDF

Info

Publication number
WO2009146947A1
WO2009146947A1 PCT/EP2009/004074 EP2009004074W WO2009146947A1 WO 2009146947 A1 WO2009146947 A1 WO 2009146947A1 EP 2009004074 W EP2009004074 W EP 2009004074W WO 2009146947 A1 WO2009146947 A1 WO 2009146947A1
Authority
WO
WIPO (PCT)
Prior art keywords
diagnostic system
catheter
data
measuring
recording
Prior art date
Application number
PCT/EP2009/004074
Other languages
German (de)
English (en)
Inventor
Andreas Schönfeld
Original Assignee
Standard Instruments Gmbh
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Standard Instruments Gmbh filed Critical Standard Instruments Gmbh
Publication of WO2009146947A1 publication Critical patent/WO2009146947A1/fr

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/05—Detecting, measuring or recording for diagnosis by means of electric currents or magnetic fields; Measuring using microwaves or radio waves
    • A61B5/053—Measuring electrical impedance or conductance of a portion of the body
    • A61B5/0538—Measuring electrical impedance or conductance of a portion of the body invasively, e.g. using a catheter
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/145—Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value ; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid or cerebral tissue
    • A61B5/14539—Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value ; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid or cerebral tissue for measuring pH
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/145—Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value ; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid or cerebral tissue
    • A61B5/14542—Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value ; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid or cerebral tissue for measuring blood gases
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/145—Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value ; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid or cerebral tissue
    • A61B5/14546—Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value ; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid or cerebral tissue for measuring analytes not otherwise provided for, e.g. ions, cytochromes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/145—Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value ; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid or cerebral tissue
    • A61B5/1468—Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value ; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid or cerebral tissue using chemical or electrochemical methods, e.g. by polarographic means
    • A61B5/1473—Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value ; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid or cerebral tissue using chemical or electrochemical methods, e.g. by polarographic means invasive, e.g. introduced into the body by a catheter
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/24—Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
    • A61B5/316—Modalities, i.e. specific diagnostic methods
    • A61B5/318—Heart-related electrical modalities, e.g. electrocardiography [ECG]
    • A61B5/333—Recording apparatus specially adapted therefor
    • A61B5/335—Recording apparatus specially adapted therefor using integrated circuit memory devices
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2560/00—Constructional details of operational features of apparatus; Accessories for medical measuring apparatus
    • A61B2560/04—Constructional details of apparatus
    • A61B2560/0475—Special features of memory means, e.g. removable memory cards
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/03—Measuring fluid pressure within the body other than blood pressure, e.g. cerebral pressure ; Measuring pressure in body tissues or organs
    • A61B5/036—Measuring fluid pressure within the body other than blood pressure, e.g. cerebral pressure ; Measuring pressure in body tissues or organs by means introduced into body tracts
    • A61B5/037—Measuring oesophageal pressure
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/24—Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
    • A61B5/316—Modalities, i.e. specific diagnostic methods
    • A61B5/389—Electromyography [EMG]
    • A61B5/392—Detecting gastrointestinal contractions

Definitions

  • the invention relates to a diagnostic system for the simultaneous long-term registration of the electrocardiogram and of measured values from the esophagus of a patient.
  • Reflux esophagitis or reflux disease is a widespread condition that occurs especially at night or while lying down, after meals, when lifting loads, but also after drinking alcohol and desserts. It comes to acid regurgitation of gastric juice and / or heartburn. Reflux esophagitis is also often associated with nonspecific upper abdominal or thoracic pain. In addition to reflux esophagitis, there are many diseases of the upper digestive tract that can also cause upper abdominal discomfort. Such disorders are commonly referred to as motility disorders.
  • Reflux esophagitis is usually due to cardia insufficiency, ie inadequate occlusion of the distal end of the esophagus as it enters the stomach, for example due to tissue weakness in the stomach Area of the diaphragm.
  • the internal sphincter that separates the esophagus from the stomach functions insufficiently.
  • ECG electrocardiogram
  • a diagnosis which is suitable for clarifying, in particular, non-specific pain in the upper abdomen and chest area and for detecting an underlying esophageal motility disorder at an early point in time.
  • a diagnosis be able to reliably distinguish a motility disorder from a heart disease or to diagnose early in a cardiologist in case of parallel occurrence.
  • a diagnostic system of the type mentioned above having a suitable for deriving the ECG probe system, also a catheter for insertion into the esophagus of a patient, the catheter via at least one probe for pH and / or impedance -Messung and optionally for determining further measurement data has a recording device with a voltage source and multiple channels for registration and recording of the measurement data and at least one memory card for time-dependent storage of the measurement data and means for data transmission from the probes to the recording device.
  • the recording system may also be divided into a sensory unit and a recording unit, wherein a wireless transmission of the measured values takes place here.
  • the diagnostic system will each have at least one measuring probe for the pH value and for the impedance measurement.
  • the diagnostic system according to the invention is designed so that it can simultaneously record and record an electrocardiogram and the data relevant for the diagnosis of motility disorder.
  • two parallel investigations can be made, which are suitable to exclude one or the other disease or to diagnose both diseases side by side.
  • ECG electrocardiogram
  • a breast derivation of the signals takes place, since in this case the patient is only slightly restricted in his freedom of movement.
  • the derivative can also be done on the extremities or directly in the esophagus. It can be bi- or unipolar.
  • a catheter is used, preferably a nasal catheter, which is usually used by the patient little discomfort.
  • a nasal catheter can have a very small diameter, for example, 1.5 mm, so that it does not interfere with the food and fluid intake practically.
  • the nasal catheter is preferably equipped with at least one, usually two pH-sensitive electrodes, one of which is located about 5 cm from the distal end of the catheter.
  • the distal end of the catheter is the end facing inside the body, as opposed to the proximal end facing the recorder which serves to guide the connection between the probes and the recorder, unless telemetric data transmission is performed.
  • the catheter is placed so that a pH measuring point is about 5 cm above the cardia.
  • the location on the catheter can be arbitrary. Actually existing catheters often have a reference electrode at the distal end, the measuring point is above it.
  • a second pH-sensitive probe may be located at the distal end of the catheter, causing it to regularly come into contact with the gastric acid itself and take a comparative reading there. In general, however, this second pH probe will be located proximal to the first probe and will provide a reading in the middle or upper part of the esophagus. There may be more than two pH-sensitive probes to determine the pathway of the esophageal reflux bolus.
  • the pH-sensitive probes are common glass, ISFET or antimony electrodes, as they have long been used for pH registration in the body.
  • the recorder is calibrated with respect to the pH measurements, ie it is adapted to the type of probe and the age of the probe, respectively. It is known that the measurement characteristics of pH probes change with age and frequency of use and therefore require calibration. Furthermore, it is expedient if the calibration and / or the measurement temperature can be set on the recording device.
  • the pH electrodes are reliable to detect the penetration of acidic gastric contents into the esophagus.
  • the catheter in particular nasal catheter, may additionally or alternatively comprise further measuring probes for determining the impedance.
  • the impedance measurement makes it possible, in particular, to detect movements of masses in the esophagus, which can not be detected via the pH electrodes, based on the change in the electrical conductivity. This is especially true for the entry of low-acid gastric contents into the esophagus - in this case, the typical symptoms of acid bumping and heartburn are absent. At the same time, however, anomalies in drinking and swallowing, peristalsis, can be diagnosed and recorded.
  • ring electrodes are used for the impedance measurement, which are applied around the catheter.
  • Such ring electrodes are known per se.
  • the diagnostic system according to the invention may additionally also have one or more pressure sensors.
  • esophageal manometry is the diagnosis of coordination disorders and the measurement of the pressure conditions of the esophageal muscles, especially in swallowing or painful passage of food into the Stomach possible.
  • malfunctions of the sphincter muscles can also be diagnosed.
  • system according to the invention can also have one or more EMG probes with which intraesophageal muscle actions can be recorded independently of the pressure generated.
  • the catheter may also have a probe for the detection of enzymes, as they are secreted in particular in the small intestine or duodenum.
  • This "small intestinal juice” also frequently exits the small intestine into the stomach and can enter the esophagus with the reflux mass. These are highly effective digestive enzymes, which can further damage the already severely damaged mucosa of the esophagus.
  • the system according to the invention can also have, alternatively or cumulatively to the measuring probes for the ECG, those for an EEG, in particular those for the derivation from the cortex.
  • the recording device itself has a conventional voltage source, for example a battery or a rechargeable battery, as well as the necessary channels for registering and recording the measurement data. Furthermore, in addition to at least one mass memory, preferably a memory card for the time-dependent storage of the measured values, there is a memory for programming the device functions.
  • the system has the necessary connections between the recording apparatus and the probes for power supply and data transmission.
  • data transmission can also be wireless (telemetric), for example via RFID systems.
  • Means for data transmission between probes and recording device are thus all suitable for signal transmission connections, whether they are via lines or wireless.
  • conventional recording devices can be used to record the measured data, as they are often described in the literature.
  • such a recording device should, in addition to a permanent memory for the measurement program, have separate memory cards for recording the ECG on the one hand and the measurement data from the esophagus on the other hand. These memory cards can be read and evaluated at the end of the examination on a conventional PC, then reconfigured for the next patient.
  • the recorder should also be programmable in terms of time duration and / or time intervals of the measurements. This is especially true for the periods over which the cardiac function is recorded, with significantly more data than for the occasional readings being taken from the esophagus from time to time. For esophageal pH data, it is usually sufficient to take a value every 4 to 20 seconds; impedance measurements are typically recorded at 50 measurements per second.
  • the recording device is preferably also adjustable to the respective measuring probe type, i. H.
  • the characteristics of conventional measuring probes are stored in the recording device and can be retrieved at any time for fast connection.
  • the system according to the invention allows a standard cardiac diagnosis in parallel to one another and, in addition, a comprehensive diagnosis of the processes in the esophagus of a patient over a relatively long period of time, for example 24 hours, but also longer.
  • the arrangement of several probes in the esophageal catheter allows not only the detection of penetrating into the esophagus masses but also the determination of the direction of movement and, where appropriate, the behavior of the esophageal musculature. In particular, it is possible to measure the direction of transport and the height to which the reflux increases. The reflux can be determined independently of its acidity.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Physics & Mathematics (AREA)
  • Engineering & Computer Science (AREA)
  • Medical Informatics (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Biophysics (AREA)
  • Pathology (AREA)
  • General Health & Medical Sciences (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Animal Behavior & Ethology (AREA)
  • Molecular Biology (AREA)
  • Surgery (AREA)
  • Optics & Photonics (AREA)
  • Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Radiology & Medical Imaging (AREA)
  • Microelectronics & Electronic Packaging (AREA)
  • Cardiology (AREA)
  • Measurement And Recording Of Electrical Phenomena And Electrical Characteristics Of The Living Body (AREA)

Abstract

L'invention concerne un système de diagnostic qui permet en même temps d'enregistrer sur une longue durée l'électrocardiogramme et la valeur du pH et/ou l'impédance et éventuellement d'autres valeurs de mesure saisies sur un patient, avec un système de sondes de mesure qui permettent de déduire l'électrocardiogramme, un cathéter destiné à être inséré dans les tubes de perfusion du patient, le cathéter disposant d'au moins une sonde de mesure de détermination de la valeur du pH et/ou de mesure de l'impédance ainsi qu'éventuellement d'autres sondes de mesure qui déterminent d'autres valeurs de mesure, un appareil d'affichage qui présente une source de tension ainsi que plusieurs canaux d'enregistrement et d'affichage des données de mesure provenant des sondes de mesure, au moins une carte de mémoire qui conserve en fonction du temps les données de mesure et des moyens de transfert des données des sondes de mesure à l'appareil d'affichage.
PCT/EP2009/004074 2008-06-05 2009-06-05 Système de diagnostic WO2009146947A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
DE102008026898A DE102008026898A1 (de) 2008-06-05 2008-06-05 Diagnostisches System
DE102008026898.4 2008-06-05

Publications (1)

Publication Number Publication Date
WO2009146947A1 true WO2009146947A1 (fr) 2009-12-10

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DE (1) DE102008026898A1 (fr)
WO (1) WO2009146947A1 (fr)

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2018019849A1 (fr) * 2016-07-25 2018-02-01 Standard Instruments Gmbh Système de diagnostic
US9918642B2 (en) 2013-10-25 2018-03-20 Fibragg Diagnostics Gmbh Pressure gauge

Citations (4)

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GB2141827A (en) * 1983-06-16 1985-01-03 Beaumont Hospital William Oesophageal function monitor
EP0366127A1 (fr) * 1988-10-25 1990-05-02 Forschungsgesellschaft für Biomedizinische Technik e.V. L'emploi d'un cathéter et dispositif de mesure destiné à la mesure de la motilité et du mouvement péristaltique des organes tubulaires par la mesure simultanée d'une pluralité d'impédances
DE10164429A1 (de) * 2001-12-29 2003-07-17 It Dr Gambert Gmbh Vorrichtung zur Messung enzymatischer Bestandteile im Körperinneren von Mensch oder Tier
DE602005001385T2 (de) * 2004-11-17 2008-02-21 Ela Medical Autonome elektronische Vorrichtung, insbesondere ein ambulantes medizinisches Aufnahmegerät, mit einem reprogrammierbaren Mikrocontroller

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* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
GB2141827A (en) * 1983-06-16 1985-01-03 Beaumont Hospital William Oesophageal function monitor
EP0366127A1 (fr) * 1988-10-25 1990-05-02 Forschungsgesellschaft für Biomedizinische Technik e.V. L'emploi d'un cathéter et dispositif de mesure destiné à la mesure de la motilité et du mouvement péristaltique des organes tubulaires par la mesure simultanée d'une pluralité d'impédances
DE10164429A1 (de) * 2001-12-29 2003-07-17 It Dr Gambert Gmbh Vorrichtung zur Messung enzymatischer Bestandteile im Körperinneren von Mensch oder Tier
DE602005001385T2 (de) * 2004-11-17 2008-02-21 Ela Medical Autonome elektronische Vorrichtung, insbesondere ein ambulantes medizinisches Aufnahmegerät, mit einem reprogrammierbaren Mikrocontroller

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Title
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LÓPEZ ALONSO M ET AL: "[Acid and non-acid gastro-esophageal reflux in newborns. Preliminar results using intraluminal impedance]", CIRUGÍA PEDIÁTRICA : ORGANO OFICIAL DE LA SOCIEDAD ESPAÑOLA DE CIRUGÍA PEDIÁTRICA JUL 2005, vol. 18, no. 3, July 2005 (2005-07-01), pages 121 - 126, XP008110283, ISSN: 0214-1221 *
PETER C S ET AL: "Gastroesophageal reflux and apnea of prematurity: No temporal relationship", PEDIATRICS 2002 US, vol. 109, no. 1, 2002, pages 8 - 11, XP002542110, ISSN: 0031-4005 *
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TRACHTERNA M ET AL: "Procedure for the semi-automatic detection of gastro-oesophageal reflux patterns in intraluminal impedance measurements in infants.", MEDICAL ENGINEERING & PHYSICS APR 1999, vol. 21, no. 3, April 1999 (1999-04-01), pages 195 - 201, XP002542113, ISSN: 1350-4533 *
WASHINGTON N ET AL: "Dual pH probe monitoring versus single pH probe monitoring in infants on milk feeds: the impact on diagnosis.", ARCHIVES OF DISEASE IN CHILDHOOD OCT 1999, vol. 81, no. 4, October 1999 (1999-10-01), pages 309 - 312, XP002542112, ISSN: 1468-2044 *

Cited By (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US9918642B2 (en) 2013-10-25 2018-03-20 Fibragg Diagnostics Gmbh Pressure gauge
WO2018019849A1 (fr) * 2016-07-25 2018-02-01 Standard Instruments Gmbh Système de diagnostic
CN109715051A (zh) * 2016-07-25 2019-05-03 标准仪器公司 诊断系统
JP2019527123A (ja) * 2016-07-25 2019-09-26 スタンダード インストゥルメンツ ゲーエムベーハーＳｔａｎｄａｒｄ Ｉｎｓｔｒｕｍｅｎｔｓ ＧｍｂＨ 診断システム

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