WO2015180753A1 - Dispositif et procédé pour l'analyse d'un milieu de mesure quant à la présence de helicobacter pylori - Google Patents

Dispositif et procédé pour l'analyse d'un milieu de mesure quant à la présence de helicobacter pylori Download PDF

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Publication number
WO2015180753A1
WO2015180753A1 PCT/EP2014/060837 EP2014060837W WO2015180753A1 WO 2015180753 A1 WO2015180753 A1 WO 2015180753A1 EP 2014060837 W EP2014060837 W EP 2014060837W WO 2015180753 A1 WO2015180753 A1 WO 2015180753A1
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WO
WIPO (PCT)
Prior art keywords
sensor
measuring
electrical contact
hbp
arrangement
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Application number
PCT/EP2014/060837
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German (de)
English (en)
Inventor
Patrick Fröse
Erhard Magori
Roland Pohle
Evamaria STÜTZ
Angelika Tawil
Oliver von Sicard
Original Assignee
Siemens Aktiengesellschaft
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Application filed by Siemens Aktiengesellschaft filed Critical Siemens Aktiengesellschaft
Priority to PCT/EP2014/060837 priority Critical patent/WO2015180753A1/fr
Publication of WO2015180753A1 publication Critical patent/WO2015180753A1/fr

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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
    • A61B5/05—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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B1/00—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor
    • A61B1/04—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor combined with photographic or television appliances
    • A61B1/041—Capsule endoscopes for imaging
    • 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
    • A61B5/07—Endoradiosondes
    • A61B5/073—Intestinal transmitters
    • 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, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue
    • A61B5/14507—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue specially adapted for measuring characteristics of body fluids other than blood
    • 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, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue
    • A61B5/14546—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, 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, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue
    • A61B5/1468—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue using chemical or electrochemical methods, e.g. by polarographic means
    • A61B5/1473—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, 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
    • A61B5/145—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue
    • A61B5/1486—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue using enzyme electrodes, e.g. with immobilised oxidase
    • A61B5/14865—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue using enzyme electrodes, e.g. with immobilised oxidase invasive, e.g. introduced into the body by a catheter or needle or using implanted sensors
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/42—Detecting, measuring or recording for evaluating the gastrointestinal, the endocrine or the exocrine systems
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/42—Detecting, measuring or recording for evaluating the gastrointestinal, the endocrine or the exocrine systems
    • A61B5/4222—Evaluating particular parts, e.g. particular organs
    • A61B5/4238—Evaluating particular parts, e.g. particular organs stomach
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/68—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
    • A61B5/6846—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive
    • A61B5/6847—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive mounted on an invasive device
    • A61B5/6861—Capsules, e.g. for swallowing or implanting
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B1/00—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor
    • A61B1/273—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor for the upper alimentary canal, e.g. oesophagoscopes, gastroscopes
    • A61B1/2736—Gastroscopes
    • 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
    • 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
    • A61B2560/0406—Constructional details of apparatus specially shaped apparatus housings
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2562/00—Details of sensors; Constructional details of sensor housings or probes; Accessories for sensors
    • A61B2562/02—Details of sensors specially adapted for in-vivo measurements
    • A61B2562/0209—Special features of electrodes classified in A61B5/24, A61B5/25, A61B5/283, A61B5/291, A61B5/296, A61B5/053
    • A61B2562/0215—Silver or silver chloride containing
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2562/00—Details of sensors; Constructional details of sensor housings or probes; Accessories for sensors
    • A61B2562/16—Details of sensor housings or probes; Details of structural supports for sensors
    • A61B2562/162—Capsule shaped sensor housings, e.g. for swallowing or implantation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2562/00—Details of sensors; Constructional details of sensor housings or probes; Accessories for sensors
    • A61B2562/24—Hygienic packaging for medical sensors; Maintaining apparatus for sensor hygiene
    • A61B2562/242—Packaging, i.e. for packaging the sensor or apparatus before use
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2562/00—Details of sensors; Constructional details of sensor housings or probes; Accessories for sensors
    • A61B2562/24—Hygienic packaging for medical sensors; Maintaining apparatus for sensor hygiene
    • A61B2562/247—Hygienic covers, i.e. for covering the sensor or apparatus during use

Definitions

  • the invention relates to an arrangement with a sensor for checking a measuring medium for the presence of
  • the invention relates to a shield of the sensor.
  • HBP Helicobacter pylori
  • HBP is a rod-shaped bacterium that can colonize the human stomach and be held responsible for a number of gastric diseases. In addition to gastritis, these include gastric ulcers as well as duodenal ulcers. In a chronic form, HBP can also cause stomach cancer. The prevalence of HBP is approximately 50% worldwide. The investigation of an infection with HBP therefore represents today an essential part of the Diag ⁇ nostik of stomach diseases.
  • An HBP infection can be treated, for example, with the aid of an eradication therapy consisting of a combination of different antibiotics. However, before such a therapy can be started, a reliable diagnosis is first necessary. If necessary, up to two independent proof tests must be positive.
  • Urease tests are detected.
  • Another approach for the detection of HBP infection consists in carrying out a breath test based on the detection of the isotopes 13C and 14C in the breath after the patient specific, 13C or 14C was administered iso- topenmarktechnische at EXISTING ⁇ densein of HBP enters certain chemical reactions in the stomach of the patient so that 13C and 14C is formed and is out ⁇ breathes. All these methods of detection as well as other however, a low level of patient acceptance is common.
  • Endoscopy capsule as shown in more detail in WO2009 / 127528A1, for example.
  • the endoscopy capsule is guided to a site to be examined in the gastrointestinal tract and a determination for Helicobacter pylori is carried out on site.
  • WO2009 / 127528A1 in which other problems of the current HBP detection methods are explained, describes an approach for the detection of HBP infection based on the introduction of a corresponding sensor in an optionally affected hollow organ of a patient.
  • the sensor is integrated into an easily swallowable endoscopy capsule and thus able to detect a metabolite of the HBP bacterium, for example ammonia, in the hollow organ and thus to identify the bacterium in situ.
  • the senor has a superficial sensor layer of silver chloride, which undergoes a measurable change in property upon contact with the bacterium or with its metabolite.
  • the property change is based on the dissolution of the silver chloroiod in the presence of ammonia, so that the corresponding sensor layer is degraded.
  • This degradation of the silver chloride layer leads to a change in an electrical measurement of the sensor, for example, to a change in the electrical potential, the electric current or the electrical resistance.
  • the presence of ammonia can be detected and thus concluded that HBP is present.
  • a similar one Sensor is also used in the above mentioned WO2010 / 094650A1.
  • the HBP sensor is already fully functionalized when inserted into the measuring area, for example into the stomach of a patient.
  • the conditions in the stomach by Pati ⁇ ent to patient may be significantly different, their influence on the functionalization of measurement to measurement is not reproducible. So you do not know the information available at the time of measurement conditions completely, for example.
  • the arrangement according to the invention has an HBP sensor for checking a measuring medium for the presence of
  • Helicobacter pylori by checking the medium for the presence of a specific substance in the medium.
  • the particular substance is preferably a metabolite of HBP, ie especially ammonia.
  • the measuring medium is the medium in which the measurement for the detection of HBP is carried out, i. in particular the gastric juice or, if it is an in-situ measurement, a nutrient solution.
  • the HBP sensor now has:
  • the electrical contact comprises silver, and where at ⁇ for detecting the specific substance on the measurement arrangement, an electrical measurement such as an electric potential, an electric current and / or electric.
  • the measuring arrangement is, for example, an electrode arrangement with a measuring electrode as electrical contact and a counter electrode.
  • the counter electrode is preferably made of one of an acid, insbesonde- re hydrochloric acid HCl, unchanging metal and the measuring ⁇ electrode is made of silver;
  • a device with which the electrical contact in a first operating state of the sensor from a certain substance potentially having components of the medium being measured is at least shielded, so that the component of the measuring medium not from outside of the sensor ge ⁇ long in the space, even if the sensor is located in the measuring medium), so that a contact of the component with the measuring ⁇ electrode can be prevented, and with which the shield can be canceled and thus the component from outside the sensor can enter the room, so that the electric If necessary, contact in a second operating state of the sensor at least with the component of the medium to be brought into contact.
  • the shielding of the sensor which protects the sensor until the time of measurement, is advantageously removed at the desired time of commencement of the measurement.
  • the sensor can first be brought into the vicinity of the center of infection unchanged, at which the ammonia concentration is highest.
  • the measurement can be done on an unchanged sensor. Since the influence of ammonia on the sensor now sharply increases, is expected as before a possibly slow and so bad he ⁇ discernible change for the measurement signal and for the electrical measurement of a sudden change in place. Accordingly, the presence of ammonia and an HBP infection with RESIZE ⁇ ßerer security can be detected.
  • the device may be specifically designed for closing and / or opening of the space such that the component of the sample medium, in the first Be ⁇ operating state in the closed space, at least not enter from the outside of HBP sensor in the room, and so that in the second operating state If the space is open, at least the component of the measuring medium can enter the room from outside the HBP sensor and come into contact with the electrical contact.
  • the device may comprise a movable cover, which is arranged in the first operating state such that the space is closed, so that the measuring medium can not enter the room from outside the sensor, and which is movable such that the space by moving the cover is openable, so that at least the component of Messmedi ⁇ ums get into the room and can come into contact with the electrical contact.
  • the electrical contact as well as optionally present further elekt ⁇ generic contacts in the form of flat strip electrodes or layer electrodes is applied to an outer surface of a sen ⁇ sor momentss the sensor, wherein the movable cover is arranged such that it forms the space in the first operating ⁇ state in cooperation with the outer surface of the senors in the region of the electrical contact and closes.
  • the space may be a chamber extending into the interior of a sensor body of the sensor in which the electrical contact is located, so that the electrical contact is arranged inside the sensor body, wherein
  • the chamber has a chamber opening which can be closed and / or opened with the movable cover,
  • the chamber opening in the open state represents a connection of the chamber with an environment of the sensor, so that the measuring medium located in the vicinity of the sensor can pass through the chamber opening into the chamber and can come into contact there with the electrical contact, and
  • the movable cover is arranged such that it closes the chamber opening in the first operating state and opens the chamber opening in the second operating state.
  • the sensor thus has a sensor body with an outer surface, wherein the space inside the sensor body is arranged below the outer surface, so that the outer surface of the sensor is largely flat. This results in the advantage that the sensor is better swallowable or insertable for examination.
  • a chloride solution is in the room, which is in contact with the electrical contact, so that a silver chloride layer forms on the surface of the electrical contact.
  • the sensor may include a reservoir for a chloride solution, wherein the reservoir is connected to the space such that the chloride solution from the reservoir into the room is conductive, so that the electrical contact with the chloride solution comes into contact.
  • the HBP sensor Before starting the test of the medium to be measured, the HBP sensor is functionalized such that the room is closed and there is a chloride solution in the room.
  • the device is suitable ⁇ takes to open the space again and to close and alternately to place the sensor several times in the first and second Radiozu ⁇ stand. This makes it possible to carry out several measurements, for example at different measuring locations.
  • the cover is preferably made of a material, which
  • the cover is made of a material which
  • the electrical contact for a bestimm ⁇ te time which is required for the dissolution of the cover, effectively shielded from the particular substance.
  • the shield is automatically released when the cover is released.
  • a dedicated mechanism that will open the room is not needed.
  • the counter electrode are also arranged in the space on ⁇ , so that the further electrical contact in the second operating state in conjunction with the electrical contact can be shielded.
  • the arrangement may, for example, be a catheter, a gastroscope, an endoscopy capsule or a biopsy forceps.
  • a method for checking a measuring medium for the presence of Helicobacter pylori by checking the measuring medium for the presence of a specific substance in the measuring medium with the inventive arrangement wiord first spent the HBP sensor of the arrangement with shielded electrical contact to a first desired location in the medium ,
  • the shield of the electrical contact is released at a given time for a first measuring ⁇ phase, so that the desired measurement location on befind ⁇ Liche measuring medium can only come into contact from the desired time with the electrical contact.
  • the electrical measurement is monitored at least in the first measuring phase ⁇ and from the monitored electrical measurement variable is closed for the presence of Helicobacter pylori in the measurement medium at the measurement location.
  • a second measuring phase after the first measurement phase, the shielding of the measuring electrode is restored, so that at least ⁇ component of the measuring medium in the second measurement phase ⁇ can not come into contact with the electrical contact.
  • the shielding of the measuring electrode is canceled, so that the measuring medium located at the measuring location can come into contact with the electrical contact in the third measuring phase.
  • the electrical measurement is not only during odd-numbered measurement phases, but also in one
  • An even measurement phase can be used to pass the HBP sensor to a different location from the first location.
  • a chloride solution is passed into the room to form a new silver chloride layer on the surface of the electrical contact for later measurement.
  • FIG. 1 shows an arrangement for detecting Helicobacter pylori in a first embodiment in a first operating state
  • FIG. 6 shows an arrangement for the detection of Helicobacter pylori in a third embodiment in the second operating state.
  • HBP Helicobacter pylori
  • the measuring medium 10 is preferably the medium in which the measurement for the detection of HBP 20 is carried out .
  • the measuring medium 10 is the gastric juice in the stomach of a patient, and the specific substance 30 is a metabolite of Helicobacter pylori 20, ie in particular ammonia. If it is an in vitro measurement, the measuring medium 10 may be a suitable nutrient solution.
  • the HBP sensor 100 is a component of an arrangement 1 sensitive to HBP or ammonia 30 with which a patient can be examined.
  • the arrangement 1 can, for example, a
  • FIGS. 1 to 4 show by way of example the design of the arrangement 1 as an endoscopy capsule. In this case, only the components are shown that are of interest for the invention, while those for a Endoskopiekapsel ty ⁇ cal components such as, for example, a permanent magnet or a camera, etc. are not shown. The same applies to Figu ⁇ ren 5 and 6, in which the arrangement 1 as the ones shown, provides gastroscope is.
  • the HBP sensor 100 has a measuring arrangement 110 for measuring an electrical measured variable with a first electrical Contact 115 and a second electrical contact 111.
  • the measuring arrangement 110 may be an electrode assembly, wherein the first electrical contact 115, a Messelekt ⁇ rode 115 and the second electrical contact 111 is a counter electrode.
  • Other embodiments of the measuring arrangement 110, which allow a measurement of an electrical measurement, are also conceivable.
  • the electrode assembly 110 or the measuring electrode 115 and the counter electrode 111 are electrically connected to an integrated spacein ⁇ 120 of the sensor 100th
  • the control unit 120 can in turn be connected to an evaluation unit 190 of the arrangement 1.
  • the control unit 120 is used on the one hand in order to measure an electrical measured variable on the electrode arrangement 110.
  • the electrical measured variable is, for example, an electrical potential, an electrical current or an electrical resistance.
  • the control unit 120 may also be necessary for the control unit 120 to provide an electrical current or an electrical voltage to the electrode arrangement 110.
  • the control unit 120 serves to receive the measured electrical measured variable and transmit it to the evaluation unit 190.
  • the control unit 120 may, for example, the measured values.
  • spei ⁇ manuals The evaluation unit 190 provides a desired Wei ⁇ ter town these data, which may consist, for example, in the extreme case. That a statement on the presence or absence of Helicobacter pylori is made at each measurement location.
  • the control unit 120 may, like the electrode arrangement 110, be arranged on or in the sensor 100. This is especially in the case of the formation of the arrangement 1 as
  • the control unit 120 such remote ⁇ classified by the sensor 100 that it for example.
  • the electrode assembly 110 can be connected to the control unit 120, for example via a cable.
  • a cable may, for example, be guided over a catheter tube, a gastroscope tube or an actuating line for a biopsy forceps.
  • the evaluation unit 190 may also independent and ent ⁇ removed from the sensor 100 may be arranged, in which case the communication between the control unit 120 and evaluation unit 190 for transmitting the data from the measurement of the electrode assembly 110 according to the arrangement of the control unit 120 via radio or via a cable.
  • the basic principle of the detection of Helicobacter pylori 20 is based on the fact that it is checked whether as a specific substance 30 a characteristic for HBP 20 metabolite in the measuring medium 10 is present.
  • the characteristic metabolite 30 or, in the case of the specific substance 30, is ammonia. Ammonia 30 comes under normal circumstances in a hollow organ of the
  • Gastrointestinal tract such as, for example, the stomach or only in very small quantities before.
  • ammonia 30 is a metabolic product of HBP 20
  • its detection suffices as a strong indication of the presence of HBP 20. Colonization of the stomach with HBP 20 can therefore be detected by measuring the ammonia content of the gastric juice or the ammonia content in the gastric mucosa becomes.
  • a possible, general measuring principle for the detection of ammonia 30 is based on the fact that the measuring electrode 115 a
  • Silver chloride layer has (not shown in detail), which in the presence of ammonia 30 enters into a chemical reaction with this. As a result, the
  • Silver chloride layer since the salt AgCl of the silver chloride layer is converted by ammonia 30 into a well-hydrated soluble silver-diamine complex [AG (H3) 2 ] and cleaved in chlorine Cl ⁇ .
  • the silver chloride is then removed from the electrode.
  • the mentioned electrical measured variable is measured at the electrode arrangement 110.
  • an electrical voltage U is applied to the electrode arrangement 110, ie between the measuring electrode 115 and the counterelectrode 111, with the aid of the control unit 120.
  • ammonia 30 is present in the measuring medium 10 at least in the vicinity of the measuring electrode 115, this will cause the silver chloride layer to be degraded. This degradation of
  • Silver chloride layer leads to a change in the electrical measurement of the electrode assembly 110, for example, to a change in the electrical potential, the electric current or the electrical resistance, as soon as the
  • Silver chloride layer is at at least one point so far to bring that a layer lying below the silver chloride layer is exposed with a different electrical potential. In the case of the figures shown here, this would be the surface of the measuring electrode 115.
  • the presence of ammonia 30 can be detected by determining a significant change in the measured variable and thus to the Presence of HBP 20 closed.
  • the sensor 100 should be positioned at a certain position in the stomach. If now the sensor 100, for example, with the help or in the form of a
  • Endoscopy capsule at the tip of a catheter or with biopsy forceps in the stomach and in the gastric juice ver ⁇ is introduced, can not be ruled out that the
  • Silver chloride layer 117 is damaged. Also, not enough shut, the sensor 100 and thus, in particular, the silver chloride layer 117 on the way to the measuring position in Ma ⁇ gene already at lower concentrations of ammonia comes into contact such that the silver chloride layer as partially 117 is reduced before the actual measurement starts. Furthermore, it is possible that by various
  • Chloride concentrations on the way to the site of potential shifts are caused, which has a similar effect on the measurement as the presence of ammonia. All this causes the measurement results to be falsified.
  • a silver chloride layer 117 which has already been partially removed at the time of the actual beginning of the measurement can cause, even in the presence of ammonia 30, the corresponding change in the measurement signal due to a lower amplitude not or only poorly recognizable.
  • the sensor 100 therefore has a device 130 with which the measuring electrode 115 can be shielded by the measuring medium 10 or at least by a component of the measuring medium 10 potentially containing the specific substance 30 in a first operating state of the sensor 100, and in particular if the sensor 100 is located in the measuring medium 10.
  • the measuring electrode 115 In shielded measuring electrode 115 at least the Components ⁇ te of the measured medium 10 to the specific substance 30, the measuring electrode 115 ⁇ therefore can not reach, so that the silver chloride layer is not attacked ⁇ 117th
  • the device 130 allows besides the measuring electrode 115 as needed with the measuring medium 10 or at least with the component of the measurement Medi ⁇ around 10 and thus with the particular substance 30 or with the ammonia to bring 30 in contact by the shield in a second Operating state of the sensor 100 is canceled.
  • the possibility of shielding ensures that a contact of the measuring medium 10 and thus possibly a contact of the Ammoni ⁇ aks 30 is prevented with the measuring electrode 115, so that in the sequence, the silver chloride layer 117 can not unintentionally pick ⁇ builds, as long as the shield exists is. Also for example, it becomes possible to control other parameters influencing the measurement, such as, for example, the conductivity between the measuring electrode and the counterelectrode . Consequently, the state of the functionalized measuring electrode 115 and thus the measuring conditions are known. On the other hand, the possibility of eliminating the shielding when required allows targeted measurements under known conditions at certain positions in the measuring medium 10. To achieve this, the sensor 100 is initially connected to the desired measuring electrode 115 with a shielded measuring electrode
  • the device 130 is actuated and thus the shieldcommunho ⁇ ben.
  • the measuring medium 10 then comes abruptly into contact with the measuring electrode 115, so that in the presence of ammonia 30, the degradation of the silver chloride layer 117 begins abruptly and a corresponding measurement signal can be detected.
  • the counter electrode 111 and the measuring electrode 115 are applied to the outer surface of the sensor body 101 in the form of flat strip electrodes or layer electrodes.
  • the device 130 may, for example, comprise a movable cover 131 is also mounted in the closed state flat on the measuring electrode 115, so that between the Abde ⁇ ckung 131 and the sensor 100 and the outer surface 102 of the sensor 100, a thin space 140 forms, in which the measuring ⁇ electrode 115 is arranged.
  • the space 140 is created accordingly causes 101 with a closed cover 131.
  • a sealed cover 131, that the measuring medium 10 may not reach the measurement electric ⁇ de 115 by the cooperation of the cover 131 with the outer surface of the sensor 100 and the sensor body.
  • the volume of the cavity 140 may be more or less pronounced.
  • the cover 131 rests directly on the measuring electrode 115 and / or on the outer surface 102, see also FIG that the space 140 with closed cover 131 comprises only a minimum volume.
  • the movable cover 131 can, if necessary, be displaced, folded down or completely removed with the aid of corresponding devices (not shown), so that the space 140 is opened and the shielding is released and the measuring electrode 115 is exposed, so that the measuring electrode 115 has a contact point the medium 100 surrounding the sensor 100 comes into contact. This is shown in FIG 2, wherein the cover 131 has been folded down as shown in FIG.
  • Such devices for corresponding actuation of a cover 131 are well known and will therefore not be explained in detail at this point.
  • the cover 131 may be a flexible membrane in an advantageous development that can be adapted ideally to the Oberflä ⁇ chen Scheme of the sensor body 101 and thus unfolds fewer disruptive influences during an investigation.
  • the cover 131 or the membrane 131 may be formed such that the counter electrode 111 can be shielded together with the measuring electrode 115 (not shown).
  • the above-explained variant of the first embodiment relates only to the fact that the measuring electrode 115 can be shielded, since the counter electrode 111 is anyway insensitive with appropriate choice of material and shielding, for example. against ammonia is accordingly not necessary. Nevertheless, the variant that the counterelectrode 111 is shieldable, for example. The advantage that it can be protected against any external physical influences ⁇ .
  • FIGS. 3 and 4 show a second embodiment of the sensor, FIG. 3 showing the sensor 100 in a first operating state with a shielded measuring electrode 115 and FIG. 4 the sensor 100 in a second operating state with the shielding of the measuring electrode 115 removed.
  • the measuring electrode 115 is located in a chamber 132 which is arranged in the interior of the sensor body 101 of the sensor 100 and accordingly extends from the outer surface 102 of the sensor 100 into the interior of the sensor 100.
  • the chamber 132 is a component of the device 130 with which the measuring electrode 115 can be shielded by the measuring medium 10 or at least by a component of the measuring medium 10 potentially containing the specific substance 30.
  • the chamber 132 has a closable chamber opening 133, which in the opened state represents a connection of the chamber 132 to the surroundings of the sensor 100, so that a medium 10 located in the vicinity of the sensor 100, for example the measuring medium, enters the chamber 132 where it can come into contact with the measuring electrode 115.
  • the closed state of the chamber 132 ie of the sensor 100 in the first operating state, the befind- in the vicinity of the sensor 100 Liehe medium 10 is prevented from entering the chamber 132, so that the measuring electrode therein 115 at ⁇ least from one the particular substance 30 is potentially shielded aufwei ⁇ send component of the measuring medium 10.
  • the device 130 For closing and opening the chamber 132 or the chamber opening 133, the device 130 has a cover 134, which can be moved as needed so that the chamber 132 is opened.
  • the cover can be moved with the aid of 134 ent ⁇ speaking devices, folded or removed completely, so that the shield removed and the measurement electrode 115 is exposed so that the surrounding and having a sensor 100 medium 10 comes into contact.
  • the cover 134 is slidable into and out of a receiving slot 137 of the device 130.
  • the counter electrode 111 may be disposed in the chamber 160.
  • the counter electrode 111 can be shielded ge ⁇ jointly with the measuring electrode 115th
  • the counter electrode as in the first exemplary example can 111th be approximate shape arranged as a flat strip electrode on the outer upper surface 102 of the sensor ⁇ 100th
  • the arrangement 1 is designed by way of example as a gastroscope.
  • the Vorrich- tung 130 has an openable and closable lung encapsulation 135, which (not visible in FIG 5) shields the sensor 100 as a whole and not only, as in the two herein are subject ⁇ memberediereeformen, the measuring electrode 115 and possibly the Counter electrode 111.
  • the encapsulation 135 thus has the same function as the covers 131 and 134 described above.
  • the sensor 100 is located in a space 136 within the encapsulation 135. If necessary, the encapsulation 135 can be opened and thus the shield can be removed, so that the measurement medium 10 can come into contact with the electrode arrangement 110 and in particular with the measurement electrode 115. Likewise, the encapsulation 135 can close again and thus restore the shielding of the measuring electrode 115.
  • the third embodiment is applied when the assembly 1 is not formed as endoscopy capsule. In the case of training as a gastroscope 1, for example.
  • a suitable encapsulation can at the Gastroskopspitze 2, where the sensor 100 is arranged to be attached 135, NEN by ei ⁇ opened in a working channel 3 of an insertion tube 5 of the gastroscope 1 guided guide wire 4 and ge ⁇ can be closed.
  • the Figure 5 shows the arrangement with a closed encapsulation, so the sensor 100 in the first mode
  • the FIG 6 shows the same arrangement with geöff ⁇ neter encapsulation 135, that in the second operating state of the sensor 100th
  • the inspection unit 120 and the evaluation unit 190 may be disposed away from the sensor 100 in the third embodiment.
  • the connection between electrode arrangement 110 and control unit 120 can be realized via the working channel 3.
  • the cover 131, 134 or 135 in the closed state prevents the measuring medium 10 from reaching the measuring electrode 115.
  • the sensor 100 is first moved to the desired measuring location with the cover 131, 134 or 135 closed. This may, for example, be a specific location in the stomach of a patient. Only there is the cover 131, 134 or 135 opened at the start of measurement, so that the measuring medium 10 located there in the now second operating state of the sensor 100, abruptly in the room 140, 132 and 136 reach and there with the measuring electrode 115 in Can contact.
  • the electrical measured variable is monitored with the measuring device 120. In the event that the limited hours ⁇ te substance is in the measured medium 10 30, the reduction of silver chloride layer 117 of the measuring electrode 115. begins This is reflected in a corresponding measurement signal to the meter 120th
  • the cover 131, 134 and 135 as ⁇ spent in the closed position and thus the Sen ⁇ sor 100 are placed in the second operating state in which it causes a shielding of the measuring electrode 115, so that a previously abolished shield restored becomes.
  • the senor 100 is first spent with such a cover positioned 131, 134 and 135 to the measurement location, that a trailing shield for the measuring electrode is achieved 115th
  • the cover 131, 134 or 135 will be operated to open or to be released and the Abschir ⁇ mung in a first measuring phase in that the measuring medium present at the measuring location 10, possibly including the ammonia, 30, into the space 140, 132 and 136 reach and can contact the measuring electrode 115 in con ⁇ tact.
  • the electrical measured variable at the electrode arrangement 110 is monitored by the measuring device 120.
  • a third measurement phase which corresponds functionally to the first measurement phase, the cover 131, 134 or 135 is again removed and thus the shielding of the measuring electrode 115 is canceled.
  • the electrical measured variable is again monitored by the measuring device 120.
  • a fourth measurement phase may follow functionally corresponds to the second measurement phase, that is, the shielding of the measuring electrode 115 is restored, in ⁇ which the cover is moved to the closed posi ⁇ tion 131, 134 and 135 ,
  • This sequence of measuring phases with alternating shielded and unshielded measurement electrode 115 can be continued accordingly, so that the thus configured Cover B ⁇ ckung 131, 134 and 135, a multiple measurement by the sensor 100 allowed.
  • the measuring electrode 115 is shielded at even-numbered measuring phases and at
  • chloride solution from the reservoir 150 may be in the room 140, 132 and 136 are routed, so that the currency ⁇ rend a previous measurement phase possibly degraded silver ⁇ chloride layer 117 of the measuring electrode 115 builds up again. Since ⁇ with it is achieved that the measuring electrode 115 and thus the sensor 100 for multiple measurements can be used, without the sensor 100 must be removed from the measuring medium 10 in the meantime, since in the meantime, possibly degraded in a measuring phase silver chloride layer 117 subsequently ⁇ conferenced in a subsequent measurement phase with shielded measuring electrode 115 can be rebuilt. With this, the sensor 100 can be brought back into a defined initial state between two measurements.
  • the reservoir can be arranged outside the sensor and the working channel 3 of the gastroscope 1 serves as the feed line 152 for the chloride solution 151 to the space 136.
  • the cover 131, 134 or 135 may consist of a layer of a material which is soluble in the measurement medium 10, for example gelatin.
  • the dissolution process of the layer 131, 134 or 135 begins, so that the sensor 100 only after a certain time, that for the dissolution of the layer 131, 134 and 135, respectively is needed for the measurement is used, since the measuring medium 10 previously did not enter the room 140, 132 and 136 and with the
  • Measuring electrode 115 can come into contact. Until then, the measuring electrode 115 is thus exposed to no disturbing or harmful influences.
  • cover 131, 134 or 135 may be formed such by appropriate material ⁇ optionally in all embodiments is that they only for the ammonia 30, or more generally only for the particular sub- punch 30, is impermeable, but no shielding for a chloride solution such as hydrochloric acid HCl and possibly other, non-interfering substances.
  • the chloride solution from the measuring medium 10 can reach the measuring electrode 115, so that the silver chloride layer 117 is constructed or, if the layer 117 is already fully built, the silver chloride layer 117 in this constructed state is obtained. Only with abolished shield also the potentially present ammonia 30 reaches the measuring electrode 115 and in turn causes a detectable degradation of the
  • Silver chloride layer 117 Silver chloride layer 117.
  • the monitoring of the electrical measured variable with the measuring device 120 can also be continued during those measuring phases during which the space 140, 132 or 136 is closed and the measuring electrode 115 is shielded.
  • the electrode arrangement 110 also has a counterelectrode 111 adjacent the measuring electrode 115, the electrical measured variable being determined with the aid of these two
  • Electrodes 111, 115 is monitored or measured.
  • the counterelectrode 111 preferably consists of one of an acid, in particular hydrochloric acid HCl, invariable metal, for example. Of stainless steel, gold, platinum or other suitable noble metal.
  • the counter electrode 111 may also be made of silver. In order to prevent a silver chloride layer from forming on such a silver counterelectrode 111 in this case, the electrode 111 can be set to a corresponding potential by means of the control unit 120.
  • For the functionalization of the sensor 100 for the detection of HBP-silver sensing electrode 115 may be before the measurement and before the introduction of the sensor 100 in the measuring medium 10 by means of ei ⁇ ner chloride solution, eg. Hydrochloric acid HCl, etched, so at the beginning of the measurement, a silver chloride layer 117 is available on the measuring electrode 115.
  • ei ⁇ ner chloride solution eg. Hydrochloric acid HCl
  • the HBP sensor 100 may, for example, be accommodated in an endocapsule as described in WO2009 / 127528A1.
  • the above-mentioned sensor body 101 may be the housing of the endocapsule or the endocapsule itself.
  • the HBP sensor 100 may be disposed on the tip of a catheter insertable into a body to be examined. As soon as the catheter tip with the sensor 100 is at the desired measuring position, a mechanism is activated, for example via a cable pull of the catheter, which causes the cover 131, 134 or 135 to be actuated and thus generates the shielding of the measuring electrode 115 or canceled.
  • the HBP sensor 100 can also be used as in the DE
  • 102013227086 described on the head of a biopsy forceps be angeord ⁇ net.
  • DE 102013227086 describes a biopsy forceps for removing a tissue sample from a cavity of a human or animal body, the biopsy forceps having a head for separating the tissue sample from the cavity and an operating device. Furthermore, the
  • Biopsy forceps on the head of an electrode assembly, with the presence of Helicobacter pylori can be detected.
  • the HBP sensor 100 can thus also be designed as such a head of a biopsy forceps.
  • the operating device of the biopsy forceps can then be adapted so that an actuation of the cover 131, 134 and 135 is possible.
  • the HBP sensor 100 may be attached to a gastroscope as described in WO2010094650A1.
  • inventive HBP sensor 100 with shieldable measuring electrode 115 can also be integrated into other corresponding devices.

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Abstract

Pour l'analyse d'un milieu de mesure quant à la présence de Helicobacter pylori, on emploie un détecteur permettant d'analyser le milieu de mesure quant à la présence d'ammoniaque. Le détecteur comporte un dispositif de mesure présentant un contact électrique en argent pour contrôler une grandeur de mesure électrique. Le contact électrique est disposé dans une chambre pouvant être fermée et/ou ouverte et le détecteur comporte un dispositif permettant de protéger, au moins contre l'ammoniaque, le contact électrique dans la chambre, de telle manière que de l'ammoniaque éventuellement présent ne peut pas pénétrer dans la chambre depuis l'extérieur du détecteur. Le dispositif permet cependant d'annuler la protection de telle manière que de l'ammoniaque éventuellement présent peut pénétrer dans la chambre. Cette protection du détecteur permet donc de protéger le contact électrique jusqu'au moment de la mesure. Ainsi, le détecteur peut être amené à l'état initialement inchangé à proximité du foyer infectieux au niveau duquel la concentration en ammoniaque est la plus élevée. La mesure peut donc s'effectuer sur un détecteur inchangé.
PCT/EP2014/060837 2014-05-26 2014-05-26 Dispositif et procédé pour l'analyse d'un milieu de mesure quant à la présence de helicobacter pylori WO2015180753A1 (fr)

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Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2018106931A1 (fr) * 2016-12-07 2018-06-14 Progenity Inc. Procédés, dispositifs et systèmes de détection du tractus gastro-intestinal

Citations (5)

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Publication number Priority date Publication date Assignee Title
WO2005113374A2 (fr) * 2004-05-21 2005-12-01 Given Imaging Ltd. Dispositif, systeme et procede d'echantillonnage in-vivo
WO2009127528A1 (fr) 2008-04-18 2009-10-22 Siemens Aktiengesellschaft Capsule endoscopique
WO2010094650A1 (fr) 2009-02-17 2010-08-26 Siemens Aktiengesellschaft Gastroscope
US20110313266A1 (en) * 2009-02-17 2011-12-22 Foertsch Stefan Endoscopic capsule
WO2013018094A1 (fr) * 2011-08-04 2013-02-07 Given Imaging Ltd. Dispositif, système et procédé de dosage immunologique in vivo

Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2005113374A2 (fr) * 2004-05-21 2005-12-01 Given Imaging Ltd. Dispositif, systeme et procede d'echantillonnage in-vivo
WO2009127528A1 (fr) 2008-04-18 2009-10-22 Siemens Aktiengesellschaft Capsule endoscopique
US20110092787A1 (en) * 2008-04-18 2011-04-21 Clemens Bulitta Endocapsule
WO2010094650A1 (fr) 2009-02-17 2010-08-26 Siemens Aktiengesellschaft Gastroscope
US20110313266A1 (en) * 2009-02-17 2011-12-22 Foertsch Stefan Endoscopic capsule
WO2013018094A1 (fr) * 2011-08-04 2013-02-07 Given Imaging Ltd. Dispositif, système et procédé de dosage immunologique in vivo

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2018106931A1 (fr) * 2016-12-07 2018-06-14 Progenity Inc. Procédés, dispositifs et systèmes de détection du tractus gastro-intestinal

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