EP2398374A1 - Endoscopic capsule - Google Patents

Endoscopic capsule

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Publication number
EP2398374A1
EP2398374A1 EP10704557A EP10704557A EP2398374A1 EP 2398374 A1 EP2398374 A1 EP 2398374A1 EP 10704557 A EP10704557 A EP 10704557A EP 10704557 A EP10704557 A EP 10704557A EP 2398374 A1 EP2398374 A1 EP 2398374A1
Authority
EP
European Patent Office
Prior art keywords
electrode
endoscopy capsule
capsule according
voltage
housing
Prior art date
Legal status (The legal status 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 status listed.)
Withdrawn
Application number
EP10704557A
Other languages
German (de)
French (fr)
Inventor
Stefan FÖRTSCH
Rainer Kuth
Karl-Heinz Maier
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Siemens AG
Original Assignee
Siemens AG
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
Priority claimed from DE102009009289A external-priority patent/DE102009009289A1/en
Priority claimed from DE102009023038A external-priority patent/DE102009023038A1/en
Priority claimed from DE102010006970A external-priority patent/DE102010006970A1/en
Application filed by Siemens AG filed Critical Siemens AG
Publication of EP2398374A1 publication Critical patent/EP2398374A1/en
Withdrawn legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/68—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
    • A61B1/04—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
    • A61B5/42—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
    • A61B2560/00—Constructional details of operational features of apparatus; Accessories for medical measuring apparatus
    • A61B2560/02—Operational features
    • A61B2560/0204—Operational features of power management
    • A61B2560/0214—Operational features of power management of power generation or supply
    • 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
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/0002—Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network
    • A61B5/0031—Implanted circuitry
    • 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
    • A61B5/48—Other medical applications
    • A61B5/4836—Diagnosis combined with treatment in closed-loop systems or methods
    • A61B5/4839—Diagnosis combined with treatment in closed-loop systems or methods combined with drug delivery

Definitions

  • the invention relates to an endoscopy capsule with a biocompatible housing, in which at least one sensor device for recording medically relevant data is arranged.
  • a common cause of discomfort in the upper gastrointestinal tract is a bacterial infestation of its organs.
  • Helicobacter pylori infestation is believed to be responsible for a whole range of gastric disorders associated with increased gastric acid secretion. These include, for example, type B gastritis, about 75% of gastric ulcers and almost all twelve-finger gut ulcers.
  • the examination of the hollow organs of the gastrointestinal tract for colonization with bacteria, in particular colonization with Helicobacter pylori, is therefore an important part of the diagnosis of gastric diseases.
  • Helicobacter pylori is detected via a breath test in which a patient is administered a C-13 masked urea.
  • the C-13 masked CO 2 resulting from the cleavage of urea (CO (NH 2 ) 2 ) into ammonia (NH 3 ) and carbon dioxide (CO 2 ) is detected in the exhaled air.
  • Other methods of detecting Helicobacter pylori are indicative of typical blood levels, such as pepsinogen or gastrin. However, such processes are expensive and only conditionally reliable.
  • Another test for Helicobacter pylori is the detection of Helicobacter pylori antigen in stool.
  • stomach for colonization with Helicobacter pylori Another possibility to examine the stomach for colonization with Helicobacter pylori is the so-called gastroscopy ("gastroscopy").
  • gastroscopy the gastroenterologist uses a biopsy to take a tissue sample (biopsy) from the gastric mucosa in order to or at a later date to investigate infection with Helicobacter pylori.
  • a well-known examination procedure for the tissue sample is, for example, the Helicobacter urease test (HU test, HUT for short).
  • the biopsy is placed in a test medium (measuring solution), which consists of a nutrient solution for this bacterium, urea and an indicator (litmus).
  • the bacterium splits the urea (CO (NH 2 ) 2) by urease into ammonia (NH 3 ) and carbon dioxide (CO2). • The ammonia then colors the indicator red. The test result can be seen after a few minutes. The onset of color change from yellow to red is not clearly identifiable under unfavorable conditions.
  • An alternative to a gastroscopy performed by means of a flexible endoscope is the use of a so-called endoscopy capsule.
  • Such an endoscopy capsule which is also referred to as a capsule endoscope or endocapsule, is designed as a passive endocapsule or as a navigable endoscope.
  • a passive endoscopy capsule moves through the patient's intestine due to peristalsis.
  • a navigable endocapsule is known, for example, from the patent with the publication number DE 101 42 253 C1 and from the corresponding patent application with the publication number US 2003/0060702 A1, where it is referred to as "endo-robot” or "endo-robot”.
  • the Endoroboter known from these publications can be navigated in a hollow organ (eg gastrointestinal tract) of a patient by means of a magnetic field which is generated by an external (ie arranged outside the patient) magnet system (coil system).
  • An integrated system for position control which includes a position measurement of the endo-robot and an automatic control of the magnetic field or the coil currents, can automatically detect and compensate for changes in the position of the endorobot in the hollow organ of the patient.
  • the endorobot can be specifically navigated to desired regions of the hollow organ.
  • This kind Capsule endoscopy is therefore also referred to as MGCE (Magnetically Guided Capsule Endoscopy).
  • Object of the present invention is to provide an endoscopy capsule, which allows a patient only a low-stress study of gastric acid and the tissue of the gastric mucosa on Helicobacter pylori.
  • the endoscopy capsule comprises a biocompatible housing in which at least one sensor device for recording medically relevant data is arranged.
  • a sensor is arranged on the outer surface of the housing, wherein the sensor comprises a first electrode made of a noble metal, which is not attacked by acid (eg hydrochloric acid, phosphoric acid, sulfuric acid, gastric acid), and a second electrode made of silver, and wherein between the first electrode and the second electrode, an electrical voltage can be applied and in the presence of ammonia between the first electrode and the second electrode, a change in an electrical variable is measurable.
  • acid eg hydrochloric acid, phosphoric acid, sulfuric acid, gastric acid
  • ammonia (NH 3 ) can be detected in a simple manner during the examination directly in the gastrointestinal tract of a patient and without taking a tissue sample.
  • the endoscopy capsule according to claim 1 thus enables the patient only a low-stress study of gastric acid and the tissue of the gastric mucosa on Helicobacter pylori.
  • the electrical voltage between the first electrode and the second electrode is equal to zero. This flows between the first electrode and the second electrode no current. Between the first electrode and the second electrode, the potential, that is to say without current, is thus advantageously measured. This hardly causes ion migration in the stomach acid.
  • the electrical voltage between the first electrode and the second electrode is an AC voltage having a variably predeterminable frequency spectrum.
  • the ions migrate to the associated electrodes, the cations (eg ammonium NH 4 + ) to the cathode and the anions (eg chloride Cl " ) to the anode in the endoscopy capsule according to claim 3, a complete charging of the first electrode (reference electrode) and a complete charging of the second electrode (measuring electrode) reliably prevented because at a sufficiently high frequency, the migration speed of the ions in the gastric acid is almost zero.
  • the second electrode which according to the invention consists of silver (Ag), cyclically switches between destruction and a structure of the silver chloride layer (AgCl). Both the destruction of the silver chloride layer and its structure can be measured, for example via an impedance measurement and compared cyclically.
  • the measurable potential differences and phase differences are characteristic of the presence of a urease activity, which can be concluded with a very high degree of certainty for the presence of Helicobacter pylori.
  • the frequency spectrum of the alternating voltage is modulated. This results in increased stability of the AC voltage, which increases the measurement accuracy and reduces the measurement time.
  • the electrical voltage between the first electrode and the second electrode is an applicable for a predetermined time DC voltage.
  • the predeterminable time for which a voltage can be applied by the user between the first electrode and the second electrode can be between zero seconds and continuously, with the user-selected electrical voltage in this case being able to be zero volts or higher.
  • a time of zero seconds or a voltage of zero volts is a passive measurement. For deviating values, an active measurement is available.
  • electrical quantities can be used as e.g. Potentials, electrical currents or electrical resistances or their changes or variables derived from the electrical quantities (for example electrical conductivity) or their changes are measured.
  • the second electrode (measuring electrode), which consists of silver (Ag) in the endoscopy capsule according to claim 1, must be etched by hydrochloric acid (HCl). This may or may not be done for the first time before delivery of the endoscopy capsule or the second electrode. However, it is also possible for the user to carry out the first-time HCl etching himself or to apply a corresponding silver chloride layer by means of a suitable electrolytic process. After its HCl etching or after its electrolytic deposition, the second electrode has on its surface a coating of silver chloride (AgCl) and is thus activated for the measurement for the detection of Helicobacter pylori.
  • HCl hydrochloric acid
  • the endoscopy capsule according to the invention allows simple control or simple regulation of the sensor or its first electrode (reference electrode) and / or its second electrode (measuring electrode), for example by a baseline correction. Furthermore, a reproducible regeneration of the sensor, in particular of the second electrode, is possible after each examination.
  • the sensitivity of the sensor or its first electrode and / or its second electrode can be adjusted in a simple manner in the endoscopy capsule according to the invention. Sensitivity adjustment can be made before and during Helicobacter pylori examination.
  • platinum (Pt) and gold (Au) come into question.
  • the sensor detects an ammonia (NH3) present in the stomach acid and in the tissue of the gastric mucous membrane on the stomach inner wall.
  • NH3 ammonia
  • the detection of ammonia is a very strong indication of the presence of Helicobacter pylori, since ammonia from the Helicobacter pylori bacteria by a cleavage of Urea is produced by urease in order to protect against the acidic environment of the gastrointestinal tract, in particular the high acid concentration in the stomach.
  • the second electrode (measuring electrode), which consists of silver (Ag) in the endoscopy capsule according to claim 1, must be etched by hydrochloric acid (HCl). After its HCl etching, the second electrode has on its surface a coating of silver chloride (AgCl) and is thus activated for the measurement for the detection of Helicobacter pylori. Activation of the second electrode is based on the following chemical reaction:
  • ammonia (NH 3 ) under normal circumstances in a hollow organ of the gastrointestinal tract, such as the stomach, due to the following neutralization reaction (formation of an ammonium cation by protonation of ammonia)
  • H + hydrogen nucleus
  • the salt AgCl (silver chloride) is split by ammonia into the silver-diamine complex [Ag (NH 3 ) 2] + and in chlorine Cl " .
  • [Ag (NH 3 ) 2 ] + is excellently soluble in water as a cation and is taken up by the gastric acid.
  • the endoscopy capsule according to the invention either an electrical voltage of zero (claim 2) or there is an electrical alternating voltage with a variably predetermined frequency spectrum (claim 3).
  • a DC voltage applied (claim 4).
  • the electrical quantity measured between the first electrode (reference electrode) and the second electrode (measuring electrode) is the electrical quantity measured between the first electrode (reference electrode) and the second electrode (measuring electrode)
  • the sensor of the endoscopy capsule can be regenerated in vivo after each individual measurement and is then available for further measurements. After leaving the endoscopy capsule, this can be disposed of or recycled. It is expedient to clean the endoscopy capsule with its sensors prior to delivery to the sterilization process with an ammoniacal rinsing solution (ammoniacal disinfectant) in order to remove possible AgCl residues.
  • ammoniacal rinsing solution ammoniacal disinfectant
  • the endoscopy capsule according to the invention can thus be used again for the detection of Helicobacter pylori after any necessary recalibration of the sensor.
  • a calibration of the sensor can be done for example by a dosage of synthetic ammonia.
  • the endoscopy capsule according to the invention allows a study of the gastric mucosa on Helicobacter pylori which is only of low stress to the patients, whereby tissue samples are taken only in the case of a suspected presence of Helicobacter pylori.
  • the removal of tissue samples may be carried out by the endoscopic If this has a biopsy device.
  • a therapy device for administering a therapeutic agent is arranged in the housing.
  • At least one data memory and / or at least one data transmission device are arranged in the housing.
  • evaluation electronics are provided in the housing.
  • the values determined by the evaluation electronics can be stored in the data memory and / or transmitted directly to a receiver device outside the human or animal body.
  • the energy required for the evaluation, the data storage and / or the data transmission is made available in an especially preferred embodiment of the endoscopy capsule by an energy store, which is preferably designed as a rechargeable energy store (rechargeable battery, capacitor).
  • an energy store which is preferably designed as a rechargeable energy store (rechargeable battery, capacitor).
  • the one-time or repeated charging of the energy store can, for example, be carried out inductively or via the two electrodes (reference electrode, measuring electrode) of the sensor arranged on the outer surface of the housing.
  • the energy store is equipped with at least one solar cell and the housing of the endoscopy capsule is transparent, at least in the region of the solar cell, then the energy store can be charged with laser light for the following examination, for example by irradiating the endoscopy capsule in the transparent area of the housing.
  • the endoscopy capsule can also be continuously supplied with the required energy inductively during an examination. The patient only has to be in the area of an alternating magnetic field.
  • the endoscopy capsule can be designed as a passive endoscopy capsule or as a navigable endoscopy capsule ("endo-robot").
  • a passive endoscopy capsule moves due to the peristalsis through the intestine of the patient, whereas in a navigable endoscopic capsule in the housing at least one magnetic element is arranged for navigation by means of a magnetic field generated by an external magnetic system.
  • the patient In order to capture all areas of the stomach wall in a patient after taking a passive endoscopy capsule, the patient assumes different positions during the examination in order to move the endoscopy capsule into different regions of his stomach.
  • the positions which the patient must take for this purpose are output by a patient monitoring system in a standardized sequence and a positive measurement result (detection of ammonia) is linked to the associated position of the patient.
  • the respective positions of the patient are preferably detected by an external video camera system with a corresponding image processing software.
  • a belt provided with a marker, e.g. reflected upon irradiation with infrared light and thus better visible to the external video camera system.
  • a navigable endoscopy capsule is administered to the patient, then the navigation of this endoscopy capsule takes place in the stomach of the patient by means of a magnetic field generated by an external (ie, outside the patient) magnet system (coil system).
  • an external magnet system coil system
  • the endoscopy capsule can be continuously supplied with the required energy inductively during an examination.
  • the patient is given an induction detector, with which he can detect the location of the endoscopy capsule within the gastrointestinal tract or in the toilet.
  • the patient may send the excreted endoscopy capsule and the induction detector to a service provider for reprocessing after completion of the examination.
  • FIGURE shows an endoscopy capsule 1, as is known, for example, from the aforementioned DE 101 42 253 C1 and from the corresponding US 2003/0060702 A1, the disclosure of which is expressly incorporated by reference.
  • the endoscopy capsule 1 (capsule endoscope, endo-robot) comprises an ellipsoidal housing 2, that is to say each having a capsule syringe at both ends.
  • the housing 2 which consists of a biocompatible material, at least one sensor device for collecting medically relevant data is arranged.
  • a sensor 3, which is part of the sensor device, is arranged on the outer surface of the housing 2.
  • the arranged in the housing 2 parts of the sensor device are known for example from DE 101 42 253 Cl and therefore not shown in the drawing.
  • the sensor 3 comprises a first electrode 4 (reference electrode) made of a noble metal, which is not vulnerable to hydrochloric acid, and a second electrode 5 (measuring electrode) made of silver (Ag).
  • the second electrode 5 has on its surface a silver chloride layer (AgCl layer) and is thus activated for the measurement for the detection of Helicobacter pylori.
  • the first electrode 4 and the second electrode 5 are arranged in the region of a capsule tip 6 at a constant distance from one another.
  • An electric voltage can be applied between the first electrode 4 and the second electrode 5, whereby, when ammonia is present, a change in an electrical quantity, for example, between the first electrode 4 and the second electrode 5 occurs. Potential, electrical current or electrical resistance, is measurable.
  • platinum (Pt) and gold (Au) come into question.
  • the first electrode 4 may be arranged on the one capsule tip and the second electrode 5 on the other capsule syringe.
  • an arrangement of the two electrodes 4 and 5 in the peripheral region of the housing 2 of the endoscopy capsule 1 can be realized.

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Abstract

The invention relates to an endoscopic capsule comprising a biocompatible housing (2) which houses at least one sensor device for acquiring medically relevant data. The endoscopic capsule is characterized in that a sensor (3) is arranged on the outer surface of the housing (2), the sensor (3) having a first electrode (4) which is produced of an acid-fast noble metal, and a second electrode (5) which is produced of silver. An electrical voltage can be applied between the first electrode (4) and the second electrode (5) and a change in an electric variable can be measured between the first electrode (4) and the second electrode (5) when ammonia is present. The endoscopic capsule according to the invention allows the screening of the gastric acid and of the tissue of the stomach lining for Helicobacter pylori in a manner that is gentle on the patient.

Description

Beschreibungdescription
EndsokopiekapseiEndsokopiekapsei
Die Erfindung betrifft eine Endoskopiekapsel mit einem biokompatiblen Gehäuse, in dem wenigstens eine Sensoreinrichtung zur Erfassung medizinisch relevanter Daten angeordnet ist.The invention relates to an endoscopy capsule with a biocompatible housing, in which at least one sensor device for recording medically relevant data is arranged.
Eine häufige Ursache für Beschwerden des oberen Gastroin- testinaltraktes ist ein bakterieller Befall seiner Organe. Beispielsweise wird ein Befall mit Helicobacter pylori für eine ganze Reihe von Magenerkrankungen verantwortlich gemacht, die mit einer verstärkten Sekretion von Magensäure einhergehen. Darunter fallen beispielsweise die Typ B- Gastritis, in etwa 75 % der Magengeschwüre und beinahe alle Zwölf-Fingerdarm-Geschwüre . Die Untersuchung der Hohlorgane des Gastrointestinaltraktes auf Besiedelung mit Bakterien, insbesondere auf Besiedelung mit Helicobacter pylori ist daher ein wichtiger Bestandteil der Diagnostik von Magenerkran- kungen.A common cause of discomfort in the upper gastrointestinal tract is a bacterial infestation of its organs. For example, Helicobacter pylori infestation is believed to be responsible for a whole range of gastric disorders associated with increased gastric acid secretion. These include, for example, type B gastritis, about 75% of gastric ulcers and almost all twelve-finger gut ulcers. The examination of the hollow organs of the gastrointestinal tract for colonization with bacteria, in particular colonization with Helicobacter pylori, is therefore an important part of the diagnosis of gastric diseases.
Helicobacter pylori wird beispielsweise über einen Atemtest nachgewiesen, bei dem einem Patienten ein C-13 maskierter Harnstoff verabreicht wird. Das bei der Spaltung von Harn- Stoff (CO (NH2) 2) in Ammoniak (NH3) und Kohlendioxid (CO2) ent¬ stehende C-13 maskierte CO2 wird in der ausgeatmeten Luft nachgewiesen. Andere Verfahren zum Nachweis von Helicobacter pylori stellen auf typische Blutwerte, wie beispielsweise Pepsinogen oder Gastrin ab. Solche Verfahren sind jedoch auf- wendig und nur bedingt zuverlässig. Ein weiterer Test auf Helicobacter pylori ist der Nachweis des Helicobacter pylori- Antigens im Stuhl.For example, Helicobacter pylori is detected via a breath test in which a patient is administered a C-13 masked urea. The C-13 masked CO 2 resulting from the cleavage of urea (CO (NH 2 ) 2 ) into ammonia (NH 3 ) and carbon dioxide (CO 2 ) is detected in the exhaled air. Other methods of detecting Helicobacter pylori are indicative of typical blood levels, such as pepsinogen or gastrin. However, such processes are expensive and only conditionally reliable. Another test for Helicobacter pylori is the detection of Helicobacter pylori antigen in stool.
Eine weitere Möglichkeit zur Untersuchung des Magens auf eine Besiedelung mit Helicobacter pylori ist die sogenannte Gastroskopie ("Magenspiegelung") . Während einer solchen Untersuchung nimmt der Gastroenterologe mittels einer Biopsie eine Gewebeprobe (Biopsat) aus der Magenschleimhaut, um diese so- fort oder zu einem späteren Zeitpunkt auf eine Infektion mit Helicobacter pylori zu untersuchen. Ein bekanntes Untersuchungsverfahren für die Gewebeprobe ist beispielsweise der Helicobacter-Urease-Test (HU-Test, kurz HUT) . Das Biopsat wird in ein Testmedium (Messlösung) gegeben, welches aus einer Nährlösung für dieses Bakterium, aus Harnstoff und aus einem Indikator (Lackmus) besteht. Ist das Helicobacter pylo- ri-Bakterium in der Probe enthalten, so spaltet das Bakterium den Harnstoff (CO (NH2) 2) durch Urease in Ammoniak (NH3) und Kohlendioxid (CO2) • Das Ammoniak färbt dann den Indikator rot. Das Testergebnis ist nach wenigen Minuten zu erkennen. Der beginnende Farbumschlag von gelb nach rot ist unter ungünstigen Bedingungen nicht eindeutig feststellbar.Another possibility to examine the stomach for colonization with Helicobacter pylori is the so-called gastroscopy ("gastroscopy"). During such an examination, the gastroenterologist uses a biopsy to take a tissue sample (biopsy) from the gastric mucosa in order to or at a later date to investigate infection with Helicobacter pylori. A well-known examination procedure for the tissue sample is, for example, the Helicobacter urease test (HU test, HUT for short). The biopsy is placed in a test medium (measuring solution), which consists of a nutrient solution for this bacterium, urea and an indicator (litmus). If the Helicobacter pylori bacterium is present in the sample, the bacterium splits the urea (CO (NH 2 ) 2) by urease into ammonia (NH 3 ) and carbon dioxide (CO2). • The ammonia then colors the indicator red. The test result can be seen after a few minutes. The onset of color change from yellow to red is not clearly identifiable under unfavorable conditions.
Eine Alternative zu einer mittels eines flexiblen Endoskops durchgeführten Gastroskopie besteht in der Verwendung einer sogenannten Endoskopiekapsel . Eine derartige Endoskopiekap- sel, die auch als Kapselendoskop oder Endokapsel bezeichnet wird, ist als passive Endokapsel oder als navigierbare Endo- kapsei ausgeführt. Eine passive Endoskopiekapsel bewegt sich aufgrund der Peristaltik durch den Darm des Patienten.An alternative to a gastroscopy performed by means of a flexible endoscope is the use of a so-called endoscopy capsule. Such an endoscopy capsule, which is also referred to as a capsule endoscope or endocapsule, is designed as a passive endocapsule or as a navigable endoscope. A passive endoscopy capsule moves through the patient's intestine due to peristalsis.
Eine navigierbare Endokapsel ist beispielsweise aus dem Patent mit der Veröffentlichungsnummer DE 101 42 253 Cl sowie aus der korrespondierenden Patentanmeldung mit der Veröffentlichungsnummer US 2003/0060702 Al bekannt und wird dort als "Endoroboter" bzw. "endo-robot" bezeichnet. Der aus diesen Veröffentlichungen bekannte Endoroboter kann mittels eines Magnetfeldes, das von einem externen (d.h. außerhalb des Pa- tienten angeordneten) Magnetsystem (Spulensystem) erzeugt wird, in einem Hohlorgan (z.B. Magen-Darm-Trakt) eines Patienten navigiert werden. Über ein integriertes System zur Lagekontrolle, das eine Positionsmessung des Endoroboters und eine automatische Regelung des Magnetfeldes bzw. der Spulen- ströme umfasst, können automatisch Änderungen der Lage des Endoroboters im Hohlorgan des Patienten erkannt und kompensiert werden. Weiterhin kann der Endoroboter gezielt in gewünschte Regionen des Hohlorgans navigiert werden. Diese Art der Kapselendoskopie wird deshalb auch als MGCE (Magnetically Guided Capsule Endoscopy - magnetisch geführte Kapselendoskopie) bezeichnet.A navigable endocapsule is known, for example, from the patent with the publication number DE 101 42 253 C1 and from the corresponding patent application with the publication number US 2003/0060702 A1, where it is referred to as "endo-robot" or "endo-robot". The Endoroboter known from these publications can be navigated in a hollow organ (eg gastrointestinal tract) of a patient by means of a magnetic field which is generated by an external (ie arranged outside the patient) magnet system (coil system). An integrated system for position control, which includes a position measurement of the endo-robot and an automatic control of the magnetic field or the coil currents, can automatically detect and compensate for changes in the position of the endorobot in the hollow organ of the patient. Furthermore, the endorobot can be specifically navigated to desired regions of the hollow organ. This kind Capsule endoscopy is therefore also referred to as MGCE (Magnetically Guided Capsule Endoscopy).
Aufgabe der vorliegenden Erfindung ist es, eine Endoskopie- kapsel zu schaffen, die eine einen Patienten nur gering belastende Untersuchung der Magensäure und des Gewebes der Magenschleimhaut auf Helicobacter pylori ermöglicht.Object of the present invention is to provide an endoscopy capsule, which allows a patient only a low-stress study of gastric acid and the tissue of the gastric mucosa on Helicobacter pylori.
Die Aufgabe wird erfindungsgemäß durch eine Endoskopiekapsel gemäß Anspruch 1 gelöst. Vorteilhafte Ausgestaltungen der erfindungsgemäßen Endoskopiekapsel sind jeweils Gegenstand von weiteren Ansprüchen.The object is achieved by an endoscopic capsule according to claim 1. Advantageous embodiments of the endoscopy capsule according to the invention are the subject of further claims.
Die erfindungsgemäße Endoskopiekapsel umfasst ein biokompatibles Gehäuse, in dem wenigstens eine Sensoreinrichtung zur Erfassung medizinisch relevanter Daten angeordnet ist. Erfindungsgemäß ist an der Außenfläche des Gehäuses ein Sensor angeordnet, wobei der Sensor eine erste Elektrode aus einem Edelmetall, das nicht durch Säure (z.B. Salzsäure, Phosphorsäure, Schwefelsäure, Magensäure) angreifbar ist, und eine zweite Elektrode aus Silber umfasst, und wobei zwischen der ersten Elektrode und der zweiten Elektrode eine elektrische Spannung anlegbar ist und bei vorhandenem Ammoniak zwischen der ersten Elektrode und der zweiten Elektrode eine Änderung einer elektrischen Größe messbar ist.The endoscopy capsule according to the invention comprises a biocompatible housing in which at least one sensor device for recording medically relevant data is arranged. According to the invention, a sensor is arranged on the outer surface of the housing, wherein the sensor comprises a first electrode made of a noble metal, which is not attacked by acid (eg hydrochloric acid, phosphoric acid, sulfuric acid, gastric acid), and a second electrode made of silver, and wherein between the first electrode and the second electrode, an electrical voltage can be applied and in the presence of ammonia between the first electrode and the second electrode, a change in an electrical variable is measurable.
Bei der Endoskopiekapsel gemäß Anspruch 1 kann auf einfache Weise während der Untersuchung unmittelbar im Gastrointesti- naltrakt eines Patienten und ohne Entnahme einer Gewebeprobe Ammoniak (NH3) nachgewiesen werden. Die Endoskopiekapsel nach Anspruch 1 ermöglicht somit eine den Patienten nur gering belastende Untersuchung der Magensäure sowie des Gewebes der Magenschleimhaut auf Helicobacter pylori.In the endoscopy capsule according to claim 1, ammonia (NH 3 ) can be detected in a simple manner during the examination directly in the gastrointestinal tract of a patient and without taking a tissue sample. The endoscopy capsule according to claim 1 thus enables the patient only a low-stress study of gastric acid and the tissue of the gastric mucosa on Helicobacter pylori.
Bei einer bevorzugten Endoskopiekapsel nach Anspruch 2 ist die elektrische Spannung zwischen der ersten Elektrode und der zweiten Elektrode gleich null. Damit fließt zwischen der ersten Elektrode und der zweiten Elektrode kein Strom. Zwischen der ersten Elektrode und der zweiten Elektrode wird somit in vorteilhafter Weise das Potential, also stromlos, gemessen. Damit findet kaum Ionenwanderung in der Magensäure statt.In a preferred endoscopic capsule according to claim 2, the electrical voltage between the first electrode and the second electrode is equal to zero. This flows between the first electrode and the second electrode no current. Between the first electrode and the second electrode, the potential, that is to say without current, is thus advantageously measured. This hardly causes ion migration in the stomach acid.
Bei einer weiteren vorteilhaften Ausgestaltung nach Anspruch 3 ist die elektrische Spannung zwischen der ersten Elektrode und der zweiten Elektrode eine Wechselspannung mit einem va- riabel vorgebbaren Frequenzspektrum. In einer mit Gleichstrom bzw. einem gerichteten Potential ausgesetzten Magensäure wandern die Ionen zu den zugehörigen Elektroden, die Kationen (z.B. Ammonium NH4 +) also zur Kathode und die Anionen (z.B. Chlorid Cl") zur Anode. Durch das Anlegen einer geeigneten Wechselspannung wird bei der Endoskopiekapsel nach Anspruch 3 ein vollständiges Aufladen der ersten Elektrode (Referenzelektrode) und ein vollständiges Aufladen der zweiten Elektrode (Messelektrode) zuverlässig verhindert, da bei einer ausreichend hohen Frequenz die Wandergeschwindigkeit der Io- nen in der Magensäure nahezu null ist.In a further advantageous embodiment according to claim 3, the electrical voltage between the first electrode and the second electrode is an AC voltage having a variably predeterminable frequency spectrum. In a gastric acid exposed to direct current or directed potential, the ions migrate to the associated electrodes, the cations (eg ammonium NH 4 + ) to the cathode and the anions (eg chloride Cl " ) to the anode in the endoscopy capsule according to claim 3, a complete charging of the first electrode (reference electrode) and a complete charging of the second electrode (measuring electrode) reliably prevented because at a sufficiently high frequency, the migration speed of the ions in the gastric acid is almost zero.
Beim Anlegen der Wechselspannung wird bei der zweiten Elektrode (Messelektrode) , die erfindungsgemäß aus Silber (Ag) besteht, zyklisch zwischen einer Zerstörung und einem Aufbau der Silberchlorid-Schicht (AgCl) gewechselt. Sowohl die Zerstörung der Silberchlorid-Schicht als auch deren Aufbau kann beispielsweise über eine Impedanzmessung gemessen und zyklisch verglichen werden. Die dabei messbaren Potentialdifferenzen und Phasenunterschiede sind charakteristisch für ein Vorhandensein einer Urease-Tätigkeit, woraus mit sehr hoher Sicherheit auf ein Vorhandensein von Helicobacter pylori geschlossen werden kann.When the alternating voltage is applied, the second electrode (measuring electrode), which according to the invention consists of silver (Ag), cyclically switches between destruction and a structure of the silver chloride layer (AgCl). Both the destruction of the silver chloride layer and its structure can be measured, for example via an impedance measurement and compared cyclically. The measurable potential differences and phase differences are characteristic of the presence of a urease activity, which can be concluded with a very high degree of certainty for the presence of Helicobacter pylori.
Gemäß einer besonders vorteilhaften Ausgestaltung nach An- spruch 25 ist das Frequenzspektrum der Wechselspannung moduliert. Dadurch erhält man eine erhöhte Stabilität der Wechselspannung, wodurch die Messgenauigkeit erhöht und die Messdauer verringert wird. Gemäß einer ebenfalls vorteilhaften Ausgestaltung nach Anspruch 4 ist die elektrische Spannung zwischen der ersten Elektrode und der zweiten Elektrode eine für eine vorgebbare Zeit anlegbare Gleichspannung. Die vorgebbare Zeit, für die zwischen der ersten Elektrode und der zweiten Elektrode vom Benutzer eine elektrische Spannung anlegbar ist, kann zwischen null Sekunden und dauernd liegen, wobei die vom Benutzer gewählte elektrische Spannung hierbei null Volt oder hö- her sein kann. Bei einer Zeit von null Sekunden bzw. einer Spannung von null Volt handelt es sich um eine passive Messung. Bei hiervon abweichenden Werten liegt eine aktive Messung vor.According to a particularly advantageous embodiment according to claim 25, the frequency spectrum of the alternating voltage is modulated. This results in increased stability of the AC voltage, which increases the measurement accuracy and reduces the measurement time. According to a likewise advantageous embodiment according to claim 4, the electrical voltage between the first electrode and the second electrode is an applicable for a predetermined time DC voltage. The predeterminable time for which a voltage can be applied by the user between the first electrode and the second electrode can be between zero seconds and continuously, with the user-selected electrical voltage in this case being able to be zero volts or higher. A time of zero seconds or a voltage of zero volts is a passive measurement. For deviating values, an active measurement is available.
Gemäß vorteilhaften Ausgestaltungen der erfindungsgemäßen En- doskopiekapsel können als elektrische Größen z.B. Potentiale, elektrische Ströme oder elektrischer Widerstände bzw. deren Änderungen oder aus den elektrischen Größen abgeleitete Größen (z.B. elektrische Leitfähigkeit) bzw. deren Änderungen gemessen werden.According to advantageous embodiments of the endoscopy capsule according to the invention, electrical quantities can be used as e.g. Potentials, electrical currents or electrical resistances or their changes or variables derived from the electrical quantities (for example electrical conductivity) or their changes are measured.
Die zweite Elektrode (Messelektrode) , die bei der Endoskopie- kapsel nach Anspruch 1 aus Silber (Ag) besteht, muss durch Salzsäure (HCl) geätzt werden. Dies kann - muss aber nicht - bereits erstmals vor der Auslieferung der Endoskopiekapsel bzw. der zweiten Elektrode erfolgen. Es ist jedoch auch möglich, dass der Anwender die erstmalige HCl-Ätzung selbst vornimmt oder durch ein geeignetes elektrolytisches Verfahren eine entsprechende Silberchlorid-Schicht aufbringt. Nach ih- rer HCl-Ätzung bzw. nach ihrer elektrolytischen Abscheidung weist die zweite Elektrode auf ihrer Oberfläche eine Be- schichtung aus Silberchlorid (AgCl) auf und ist damit für die Messung zum Nachweis von Helicobacter pylori aktiviert.The second electrode (measuring electrode), which consists of silver (Ag) in the endoscopy capsule according to claim 1, must be etched by hydrochloric acid (HCl). This may or may not be done for the first time before delivery of the endoscopy capsule or the second electrode. However, it is also possible for the user to carry out the first-time HCl etching himself or to apply a corresponding silver chloride layer by means of a suitable electrolytic process. After its HCl etching or after its electrolytic deposition, the second electrode has on its surface a coating of silver chloride (AgCl) and is thus activated for the measurement for the detection of Helicobacter pylori.
Bei der Endoskopiekapsel nach Anspruch 1 kann auf einfacheIn the endoscopy capsule according to claim 1 may be simple
Weise während der Untersuchung unmittelbar im Gastrointesti- naltrakt des Patienten und ohne Entnahme einer Gewebeprobe Ammoniak (NH3) nachgewiesen werden. Die erfindungsgemäße Endoskopiekapsel ermöglicht eine einfache Steuerung bzw. eine einfache Regelung des Sensors bzw. seiner ersten Elektrode (Referenzelektrode) und/oder seiner zweiten Elektrode (Messelektrode), z.B. durch eine Basislinien-Korrektur. Weiterhin ist nach jeder Untersuchung eine reproduzierbare Regeneration des Sensors, insbesondere der zweiten Elektrode möglich.Be detected during the examination directly in the gastrointestinal tract of the patient and without taking a sample of ammonia (NH 3 ). The endoscopy capsule according to the invention allows simple control or simple regulation of the sensor or its first electrode (reference electrode) and / or its second electrode (measuring electrode), for example by a baseline correction. Furthermore, a reproducible regeneration of the sensor, in particular of the second electrode, is possible after each examination.
Werden die in den Ansprüchen 2 bis 4 genannten Maßnahmen ergriffen, dann tritt ein vollständiges Aufladen der zweiten Elektrode nicht auf, so dass eine Regeneration der zweiten Elektrode erst nach einer Vielzahl von Untersuchungen notwendig ist.If the measures mentioned in claims 2 to 4 taken, then a complete charging of the second electrode does not occur, so that a regeneration of the second electrode is necessary only after a variety of studies.
Außerdem kann bei der erfindungsgemäßen Endoskopiekapsel die Empfindlichkeit des Sensors bzw. seiner ersten Elektrode und/oder seiner zweiten Elektrode auf einfache Weise eingestellt werden. Die Einstellung der Empfindlichkeit kann vor und während der Untersuchung auf Helicobacter pylori vorgenommen werden.In addition, the sensitivity of the sensor or its first electrode and / or its second electrode can be adjusted in a simple manner in the endoscopy capsule according to the invention. Sensitivity adjustment can be made before and during Helicobacter pylori examination.
Als Edelmetalle, die nicht durch Säure angegriffen werden und damit für die erste Elektrode (Referenzelektrode) geeignet sind, kommen Platin (Pt) und Gold (Au) in Frage.As noble metals that are not attacked by acid and thus suitable for the first electrode (reference electrode), platinum (Pt) and gold (Au) come into question.
Nachdem der Patient die erfindungsgemäße Endoskopiekapsel geschluckt hat, detektiert der Sensor einen in der Magensäure und im Gewebe der Magenschleimhaut an der Mageninnenwand vor- handenen Ammoniak (NH3) . Damit wird ein Befall des Gewebes (Magenschleimhaut) mit Helicobacter pylori in patientenfreundlicher Weise durch den Nachweis von Ammoniak (NH3) erkannt. Dies erfolgt ohne Biopsie und ist damit für den Patienten deutlich weniger belastend.After the patient has swallowed the endoscopy capsule according to the invention, the sensor detects an ammonia (NH3) present in the stomach acid and in the tissue of the gastric mucous membrane on the stomach inner wall. Thus, an infection of the tissue (gastric mucosa) with Helicobacter pylori in a patient-friendly manner detected by the detection of ammonia (NH 3 ). This is done without biopsy and is thus much less stressful for the patient.
Der Nachweis von Ammoniak stellt ein sehr starkes Indiz für das Vorhandensein von Helicobacter pylori dar, da Ammoniak von den Helicobacter pylori-Bakterien durch eine Spaltung von Harnstoff durch Urease erzeugt wird, um sich vor der sauren Umgebung des Gastrointestinaltraktes, insbesondere der hohen Säurekonzentration im Magen, zu schützen.The detection of ammonia is a very strong indication of the presence of Helicobacter pylori, since ammonia from the Helicobacter pylori bacteria by a cleavage of Urea is produced by urease in order to protect against the acidic environment of the gastrointestinal tract, in particular the high acid concentration in the stomach.
Die zweite Elektrode (Messelektrode) , die bei der Endoskopie- kapsel nach Anspruch 1 aus Silber (Ag) besteht, muss durch Salzsäure (HCl) geätzt werden. Nach ihrer HCl-Ätzung weist die zweite Elektrode auf ihrer Oberfläche eine Beschichtung aus Silberchlorid (AgCl) auf und ist damit für die Messung zum Nachweis von Helicobacter pylori aktiviert. Der Aktivierung der zweiten Elektrode liegt die folgende chemische Reaktion zugrunde:The second electrode (measuring electrode), which consists of silver (Ag) in the endoscopy capsule according to claim 1, must be etched by hydrochloric acid (HCl). After its HCl etching, the second electrode has on its surface a coating of silver chloride (AgCl) and is thus activated for the measurement for the detection of Helicobacter pylori. Activation of the second electrode is based on the following chemical reaction:
Ag + HCl → AgCl + H+ + e" Ag + HCl → AgCl + H + + e "
Da Ammoniak (NH3) unter normalen Umständen in einem Hohlorgan des Gastrointestinaltraktes, wie beispielsweise dem Magen, aufgrund der folgenden Neutralisationsreaktion (Bildung eines Ammonium-Kations durch Protonierung von Ammoniak)Since ammonia (NH 3 ) under normal circumstances in a hollow organ of the gastrointestinal tract, such as the stomach, due to the following neutralization reaction (formation of an ammonium cation by protonation of ammonia)
NH3 + H+ ^=^ NH4 + NH 3 + H + ^ = ^ NH 4 +
nicht oder nur in sehr geringer Konzentration vorkommt, genügt sein Nachweis als sehr starkes Indiz für das Vorhanden- sein von Helicobacter pylori. Das Proton (H+, Wasserstoffkern) ist Bestandteil der Magensäure.is not present or only in very low concentration, its proof suffices as very strong indication for the presence of Helicobacter pylori. The proton (H + , hydrogen nucleus) is a component of stomach acid.
Die für den Nachweis von Helicobacter pylori entsprechende chemische Reaktion lautet:The chemical reaction corresponding to the detection of Helicobacter pylori is:
AgCl + 2 NH3 → [Ag (NH3) 2]+ + Cl" AgCl + 2 NH 3 → [Ag (NH 3 ) 2 ] + + Cl "
Das Salz AgCl (Silberchlorid) wird durch Ammoniak in den SiI- ber-Diamin-Komplex [Ag (NH3) 2] + und in Chlor Cl" aufgespaltet. [Ag (NH3) 2] + ist als Kation hervorragend in Wasser löslich und wird von der Magensäure aufgenommen. Zwischen der ersten Elektrode (Referenzelektrode) und der zweiten Elektrode (Messelektrode) liegt gemäß vorteilhaften Ausführungsformen der erfindungsgemäßen Endoskopiekapsel entweder eine elektrische Spannung von Null an (Anspruch 2) oder es liegt eine elektrische Wechselspannung mit einem variabel vorgebbaren Frequenzspektrum an (Anspruch 3) . Alternativ dazu kann zwi- sehen der ersten Elektrode und der zweiten Elektrode für eine vorgebbare Zeit eine Gleichspannung anliegen (Anspruch 4) . In allen Fällen findet kaum Ionenwanderung in der Magensäure statt (Wandergeschwindigkeit der Kationen und der Anionen nahezu null) .The salt AgCl (silver chloride) is split by ammonia into the silver-diamine complex [Ag (NH 3 ) 2] + and in chlorine Cl " . [Ag (NH 3 ) 2 ] + is excellently soluble in water as a cation and is taken up by the gastric acid. According to advantageous embodiments, there is between the first electrode (reference electrode) and the second electrode (measuring electrode) the endoscopy capsule according to the invention either an electrical voltage of zero (claim 2) or there is an electrical alternating voltage with a variably predetermined frequency spectrum (claim 3). Alternatively, see between the first electrode and the second electrode for a predetermined time a DC voltage applied (claim 4). In all cases, there is hardly any ion migration in the gastric acid (migration rate of the cations and the anions nearly zero).
Die zwischen der ersten Elektrode (Referenzelektrode) und der zweiten Elektrode (Messelektrode) gemessene elektrische GrößeThe electrical quantity measured between the first electrode (reference electrode) and the second electrode (measuring electrode)
(Potential, elektrischer Strom, elektrischer Widerstand) wird protokolliert, angezeigt und - falls gewünscht - an eine Aus- werteelektronik übermittelt. Durch einen (automatisierten)(Potential, electrical current, electrical resistance) is logged, displayed and - if desired - transmitted to an evaluation electronics. By one (automated)
Vergleich des Messwerts mit vorgegebenen Werten kann ein möglicher Befall der Magenschleimhaut auf Helicobacter pylori zuverlässig angezeigt werden.Comparing the reading with given values, a possible gastric mucosal involvement on Helicobacter pylori can be reliably displayed.
Der Sensor der Endoskopiekapsel kann nach jeder Einzelmessung in vivo regeneriert werden und steht danach für weitere Messungen zur Verfügung. Nach dem Ausscheiden der Endoskopiekapsel kann diese entsorgt oder einer Wiederverwertung zugeführt werden. Es ist zweckmäßig, die Endoskopiekapsel mit ihren Sensoren vor der Zubringung zum Sterilisationsprozess mit einer ammoniakalischen Spüllösung (ammoniakalisches Desinfektionsmittel) zu reinigen, um mögliche AgCl-Reste zu entfernen. Die erfindungsgemäße Endoskopiekapsel kann somit nach einer eventuell notwendigen Rekalibrierung des Sensors erneut zum Nachweis von Helicobacter pylori eingesetzt werden. Eine Kalibrierung des Sensors kann beispielsweise durch eine Dosierung von synthetischem Ammoniak erfolgen.The sensor of the endoscopy capsule can be regenerated in vivo after each individual measurement and is then available for further measurements. After leaving the endoscopy capsule, this can be disposed of or recycled. It is expedient to clean the endoscopy capsule with its sensors prior to delivery to the sterilization process with an ammoniacal rinsing solution (ammoniacal disinfectant) in order to remove possible AgCl residues. The endoscopy capsule according to the invention can thus be used again for the detection of Helicobacter pylori after any necessary recalibration of the sensor. A calibration of the sensor can be done for example by a dosage of synthetic ammonia.
Die erfindungsgemäße Endoskopiekapsel erlaubt eine den Pati- enten nur gering belastende Untersuchung der Magenschleimhaut auf Helicobacter pylori, wobei erst bei einem Verdacht auf Anwesenheit von Helicobacter pylori Gewebeproben entnommen werden. Die Entnahme von Gewebeproben kann von der Endosko- piekapsel vorgenommen werden, falls diese eine Biopsieein- richtung besitzt.The endoscopy capsule according to the invention allows a study of the gastric mucosa on Helicobacter pylori which is only of low stress to the patients, whereby tissue samples are taken only in the case of a suspected presence of Helicobacter pylori. The removal of tissue samples may be carried out by the endoscopic If this has a biopsy device.
Zusätzlich zum erfindungsgemäß vorgesehenen Sensor ist bei einer vorteilhaften Ausgestaltung der Endoskopiekapsel im Gehäuse eine Therapievorrichtung zur Verabreichung eines Therapiemittels angeordnet.In addition to the sensor provided according to the invention, in an advantageous embodiment of the endoscopy capsule, a therapy device for administering a therapeutic agent is arranged in the housing.
Gemäß weiterer vorteilhafter Ausführungsbeispiele der erfin- dungsgemäßen Endoskopiekapsel sind in dem Gehäuse wenigstens ein Datenspeicher und/oder wenigstens eine Datenübertragungseinrichtung angeordnet.According to further advantageous embodiments of the endoscopy capsule according to the invention, at least one data memory and / or at least one data transmission device are arranged in the housing.
Weiterhin ist gemäß einer bevorzugten Ausführungsform der En- doskopiekapsel im Gehäuse eine Auswerteelektronik vorgesehen. Die von der Auswerteelektronik ermittelten Werte sind im Datenspeicher speicherbar und/oder direkt an eine Empfängereinrichtung außerhalb des menschlichen oder tierischen Körpers übermittelbar .Furthermore, in accordance with a preferred embodiment of the endoscopy capsule, evaluation electronics are provided in the housing. The values determined by the evaluation electronics can be stored in the data memory and / or transmitted directly to a receiver device outside the human or animal body.
Die für die Auswertung, die Datenspeicherung und/oder die Datenübertragung erforderliche Energie wird in einer besonders bevorzugten Ausgestaltung der Endoskopiekapsel durch einen Energiespeicher zur Verfügung gestellt, der vorzugsweise als wiederaufladbarer Energiespeicher (Akku, Kondensator) ausgeführt ist.The energy required for the evaluation, the data storage and / or the data transmission is made available in an especially preferred embodiment of the endoscopy capsule by an energy store, which is preferably designed as a rechargeable energy store (rechargeable battery, capacitor).
Die einmalige oder wiederholte Aufladung des Energiespeichers kann beispielsweise induktiv oder über die beiden Elektroden (Referenzelektrode, Messelektrode) des an der Außenfläche des Gehäuses angeordneten Sensors erfolgen. Ist der Energiespeicher mit wenigstens einer Solarzelle ausgestattet und ist das Gehäuse der Endoskopiekapsel zumindest im Bereich der Solarzelle transparent, dann kann der Energiespeicher z.B. durch eine Bestrahlung der Endoskopiekapsel im transparenten Bereich des Gehäuses mit Laserlicht für die folgende Untersuchung aufgeladen werden. Alternativ zu einem vor Untersuchungsbeginn aufgeladenen Energiespeicher kann die Endoskopiekapsel während einer Untersuchung auch kontinuierlich induktiv mit der benötigten Energie versorgt werden. Der Patient muss sich hierzu nur im Bereich eines Wechselmagnetfeldes aufhalten.The one-time or repeated charging of the energy store can, for example, be carried out inductively or via the two electrodes (reference electrode, measuring electrode) of the sensor arranged on the outer surface of the housing. If the energy store is equipped with at least one solar cell and the housing of the endoscopy capsule is transparent, at least in the region of the solar cell, then the energy store can be charged with laser light for the following examination, for example by irradiating the endoscopy capsule in the transparent area of the housing. As an alternative to an energy store charged before the start of the investigation, the endoscopy capsule can also be continuously supplied with the required energy inductively during an examination. The patient only has to be in the area of an alternating magnetic field.
Im Rahmen der Erfindung kann die Endoskopiekapsel als passive Endoskopiekapsel oder als navigierbare Endoskopiekapsel ("En- doroboter") ausgeführt sein. Eine passive Endoskopiekapsel bewegt sich aufgrund der Peristaltik durch den Darm des Patienten, wohingegen bei einer navigierbaren Endoskopiekapsel im Gehäuse wenigstens ein Magnetelement zur Navigation mittels eines von einem externen Magnetsystem erzeugbaren Magnetfeldes angeordnet ist.Within the scope of the invention, the endoscopy capsule can be designed as a passive endoscopy capsule or as a navigable endoscopy capsule ("endo-robot"). A passive endoscopy capsule moves due to the peristalsis through the intestine of the patient, whereas in a navigable endoscopic capsule in the housing at least one magnetic element is arranged for navigation by means of a magnetic field generated by an external magnetic system.
Um bei einem Patienten nach der Einnahme einer passiven Endoskopiekapsel alle Bereiche seiner Magenwand zu erfassen, nimmt der Patient während der Untersuchung unterschiedliche Positionen ein, um dadurch die Endoskopiekapsel in verschie- dene Regionen seines Magens zu bewegen. In vorteilhafter Weise werden die Positionen, die der Patient hierfür einnehmen muss, von einem Patientenüberwachungssystem in einer standardisierten Sequenz ausgegeben und ein positives Messergebnis (Nachweis von Ammoniak) mit der zugehörigen Position des Pa- tienten verknüpft. Die jeweiligen Positionen des Patienten werden hierbei vorzugsweise von einem externen Videokamerasystem mit einer entsprechenden Bildverarbeitungssoftware er- fasst. Um die Positionserfassung des Patienten zu verbessern, kann dieser beispielsweise einen Gürtel tragen, der mit einer Markierung versehen ist, die z.B. bei einer Bestrahlung mit Infrarotlicht reflektiert und damit besser für das externe Videokamerasystem erkennbar ist.In order to capture all areas of the stomach wall in a patient after taking a passive endoscopy capsule, the patient assumes different positions during the examination in order to move the endoscopy capsule into different regions of his stomach. Advantageously, the positions which the patient must take for this purpose are output by a patient monitoring system in a standardized sequence and a positive measurement result (detection of ammonia) is linked to the associated position of the patient. The respective positions of the patient are preferably detected by an external video camera system with a corresponding image processing software. For example, in order to improve the position detection of the patient, he may wear a belt provided with a marker, e.g. reflected upon irradiation with infrared light and thus better visible to the external video camera system.
Wird dem Patienten eine navigierbare Endoskopiekapsel verab- reicht, dann erfolgt die Navigation dieser Endoskopiekapsel im Magen des Patienten mittels eines Magnetfeldes, das von einem externen (d.h. außerhalb des Patienten angeordneten) Magnetsystem (Spulensystem) erzeugt wird. Durch das vom Spu- lensystem erzeugte Wechselmagnetfeld kann darüber hinaus die Endoskopiekapsel während einer Untersuchung kontinuierlich induktiv mit der benötigten Energie versorgt werden.If a navigable endoscopy capsule is administered to the patient, then the navigation of this endoscopy capsule takes place in the stomach of the patient by means of a magnetic field generated by an external (ie, outside the patient) magnet system (coil system). By the In addition, the endoscopy capsule can be continuously supplied with the required energy inductively during an examination.
Falls eine in der DE 10 2007 017 267 Al beschriebene Wiederverwertung der Endoskopiekapsel gewünscht ist, dann wird dem Patienten ein Induktionsdetektor ausgehändigt, mit dem er den Ort der Endoskopiekapsel innerhalb des Magen-Darm-Traktes oder in der Toilette erfassen kann. Der Patient kann nach der Beendigung der Untersuchung die ausgeschiedene Endoskopiekapsel und den Induktionsdetektor an einen Dienstleister zu Wiederaufbereitung schicken.If a reuse of the endoscopy capsule described in DE 10 2007 017 267 A1 is desired, then the patient is given an induction detector, with which he can detect the location of the endoscopy capsule within the gastrointestinal tract or in the toilet. The patient may send the excreted endoscopy capsule and the induction detector to a service provider for reprocessing after completion of the examination.
Die Erfindung sowie weitere vorteilhafte Ausgestaltungen wer- den im Folgenden anhand eines schematisch dargestellten Ausführungsbeispiels in der Zeichnung näher erläutert, ohne jedoch auf das erläuterte Ausführungsbeispiel beschränkt zu sein .The invention and further advantageous embodiments will be explained in more detail below with reference to a schematically illustrated embodiment in the drawing, but without being limited to the illustrated embodiment.
Die einzige Figur zeigt eine Endoskopiekapsel 1, wie sie beispielsweise aus der eingangs genannten DE 101 42 253 Cl sowie aus der korrespondierenden US 2003/0060702 Al bekannt ist, wobei auf deren Offenbarung ausdrücklich Bezug genommen wird.The sole FIGURE shows an endoscopy capsule 1, as is known, for example, from the aforementioned DE 101 42 253 C1 and from the corresponding US 2003/0060702 A1, the disclosure of which is expressly incorporated by reference.
Die Endoskopiekapsel 1 (Kapselendoskop, Endoroboter) umfasst ein ellipsoidförmiges Gehäuse 2, weist also an beiden Enden jeweils eine Kapselspritze auf. In dem Gehäuse 2, das aus einem biokompatiblen Material besteht, ist wenigstens eine Sensoreinrichtung zur Erfassung medizinisch relevanter Daten an- geordnet.The endoscopy capsule 1 (capsule endoscope, endo-robot) comprises an ellipsoidal housing 2, that is to say each having a capsule syringe at both ends. In the housing 2, which consists of a biocompatible material, at least one sensor device for collecting medically relevant data is arranged.
Erfindungsgemäß ist an der Außenfläche des Gehäuses 2 ein Sensor 3 angeordnet, der Teil der Sensoreinrichtung ist. Die im Gehäuse 2 angeordneten Teile der Sensoreinrichtung sind z.B. aus der DE 101 42 253 Cl bekannt und deshalb in der Zeichnung nicht dargestellt. Der Sensor 3 umfasst eine erste Elektrode 4 (Referenzelektrode) aus einem Edelmetall, das nicht durch Salzsäure angreifbar ist, und eine zweite Elektrode 5 (Messelektrode) aus Silber (Ag) . Die zweite Elektrode 5 weist auf ihrer Oberfläche eine Silberchlorid-Schicht (AgCl-Schicht) auf und ist damit für die Messung zum Nachweis von Helicobacter pylori aktiviert .According to the invention, a sensor 3, which is part of the sensor device, is arranged on the outer surface of the housing 2. The arranged in the housing 2 parts of the sensor device are known for example from DE 101 42 253 Cl and therefore not shown in the drawing. The sensor 3 comprises a first electrode 4 (reference electrode) made of a noble metal, which is not vulnerable to hydrochloric acid, and a second electrode 5 (measuring electrode) made of silver (Ag). The second electrode 5 has on its surface a silver chloride layer (AgCl layer) and is thus activated for the measurement for the detection of Helicobacter pylori.
Im dargestellten Ausführungsbeispiel der Endoskopiekapsel 1 sind die erste Elektrode 4 und die zweite Elektrode 5 im Bereich einer Kapselspitze 6 in einem konstanten Abstand zueinander angeordnet.In the illustrated embodiment of the endoscopy capsule 1, the first electrode 4 and the second electrode 5 are arranged in the region of a capsule tip 6 at a constant distance from one another.
Zwischen der ersten Elektrode 4 und der zweiten Elektrode 5 ist eine elektrische Spannung anlegbar, wodurch bei vorhandenem Ammoniak zwischen der ersten Elektrode 4 und der zweiten Elektrode 5 eine Änderung einer elektrischen Größe, z.B. Potential, elektrischer Strom oder elektrischer Widerstand, messbar ist.An electric voltage can be applied between the first electrode 4 and the second electrode 5, whereby, when ammonia is present, a change in an electrical quantity, for example, between the first electrode 4 and the second electrode 5 occurs. Potential, electrical current or electrical resistance, is measurable.
Als Edelmetalle, die nicht durch Salzsäure angegriffen werden und damit für die erste Elektrode 4 geeignet sind, kommen Platin (Pt) und Gold (Au) in Frage.As noble metals which are not attacked by hydrochloric acid and thus suitable for the first electrode 4, platinum (Pt) and gold (Au) come into question.
Im Rahmen der Erfindung sind alternativ oder zusätzlich auch andere Anordnungen des Sensors 3 bzw. der ersten Elektrode 4 und/oder der zweiten Elektrode 5 möglich. So kann z.B. die erste Elektrode 4 an der einen Kapselspitze und die zweite Elektrode 5 an der anderen Kapselspritze angeordnet sein. Als weitere Variante ist auch eine Anordnung der beiden Elektroden 4 und 5 im Umfangsbereich des Gehäuses 2 der Endoskopiekapsel 1 realisierbar. In the context of the invention, alternatively or additionally, other arrangements of the sensor 3 or the first electrode 4 and / or the second electrode 5 are possible. Thus, e.g. the first electrode 4 may be arranged on the one capsule tip and the second electrode 5 on the other capsule syringe. As a further variant, an arrangement of the two electrodes 4 and 5 in the peripheral region of the housing 2 of the endoscopy capsule 1 can be realized.

Claims

Patentansprüche claims
1. Endoskopiekapsel mit einem biokompatiblen Gehäuse (2), in dem wenigstens eine Sensoreinrichtung zur Erfassung medizi- nisch relevanter Daten angeordnet ist, dadurch gekennzeichnet, dass an der Außenfläche des Gehäuses (2) ein Sensor (3) angeordnet ist, wobei der Sensor (3) eine erste Elektrode (4; aus einem Edelmetall, das nicht durch Säure angreifbar ist, und eine zweite Elektrode (5) aus Silber umfasst, und wobei zwischen der ersten Elektrode (4) und der zweiten Elektrode (5) eine elektrische Spannung anlegbar ist und bei vorhandenem Ammoniak zwischen der ersten Elektrode (4) und der zweiten Elektrode (5) eine Änderung einer elektrischen Größe messbar ist.1. Endoscopy capsule with a biocompatible housing (2), in which at least one sensor device for acquiring medically relevant data is arranged, characterized in that a sensor (3) is arranged on the outer surface of the housing (2), wherein the sensor ( 3) comprises a first electrode (4) made of a noble metal which is not attackable by acid and a second electrode (5) made of silver, and wherein an electrical voltage can be applied between the first electrode (4) and the second electrode (5) is and in the presence of ammonia between the first electrode (4) and the second electrode (5) a change in electrical size is measurable.
2. Endoskopiekapsel nach Anspruch 1, dadurch gekennzeichnet, dass die elektrische Spannung zwischen der ersten Elektrode2. Endoscopy capsule according to claim 1, characterized in that the electrical voltage between the first electrode
(4) und der zweiten Elektrode (5) gleich null ist.(4) and the second electrode (5) is zero.
3. Endoskopiekapsel nach Anspruch 1, dadurch gekennzeichnet, dass die elektrische Spannung zwischen der ersten Elektrode (4) und der zweiten Elektrode (5) eine Wechselspannung mit einem variabel vorgebbaren Frequenzspektrum ist.3. Endoscopy capsule according to claim 1, characterized in that the electrical voltage between the first electrode (4) and the second electrode (5) is an AC voltage having a variably predeterminable frequency spectrum.
4. Endoskopiekapsel nach Anspruch 1, dadurch gekennzeichnet, dass die elektrische Spannung zwischen der ersten Elektrode (4) und der zweiten Elektrode (5) eine Gleichspannung ist, die für eine vorgebbare Zeit anlegbar ist.4. endoscopy capsule according to claim 1, characterized in that the electrical voltage between the first electrode (4) and the second electrode (5) is a DC voltage, which can be applied for a predetermined time.
5. Endoskopiekapsel nach Anspruch 1, dadurch gekennzeichnet, dass als elektrische Größe ein Potential messbar ist.5. Endoscopy capsule according to claim 1, characterized in that a potential is measurable as electrical variable.
6. Endoskopiekapsel nach Anspruch 1, dadurch gekennzeichnet, dass als elektrische Größe ein elektrischer Strom messbar ist. 6. Endoscopy capsule according to claim 1, characterized in that an electrical current is measurable as electrical variable.
7. Endoskopiekapsel nach Anspruch 1, dadurch gekennzeichnet, dass als elektrische Größe ein elektrischer Widerstand messbar ist.7. Endoscopy capsule according to claim 1, characterized in that an electrical resistance is measurable as an electrical variable.
8. Endoskopiekapsel nach Anspruch 1, dadurch gekennzeichnet, dass die erste Elektrode (4) aus Platin oder aus Gold besteht .8. Endoscopy capsule according to claim 1, characterized in that the first electrode (4) consists of platinum or gold.
9. Endoskopiekapsel nach Anspruch 1, dadurch gekennzeichnet, dass die zweite Elektrode (5) eine Silberchlorid-Schicht aufweist .9. endoscopy capsule according to claim 1, characterized in that the second electrode (5) has a silver chloride layer.
10. Endoskopiekapsel nach Anspruch 1, dadurch gekennzeichnet, dass der Sensor (3) auswechselbar ist.10. endoscopy capsule according to claim 1, characterized in that the sensor (3) is replaceable.
11. Endoskopiekapsel nach Anspruch 1, dadurch gekennzeichnet, dass der Sensor (3) regenerierbar ist.11. endoscopy capsule according to claim 1, characterized in that the sensor (3) is regenerable.
12. Endoskopiekapsel nach Anspruch 1, dadurch gekennzeichnet, dass in dem Gehäuse (2) wenigstens eine Therapievorrichtung zur Verabreichung eines Therapiemittels angeordnet ist.12. Endoscopy capsule according to claim 1, characterized in that in the housing (2) at least one therapy device for administering a therapeutic agent is arranged.
13. Endoskopiekapsel nach Anspruch 1, dadurch gekennzeichnet, dass in dem Gehäuse (2) wenigstens ein Magnetelement zur Na- vigation mittels eines von einem externen Magnetsystem erzeugbaren Magnetfeldes angeordnet ist.13. Endoscopy capsule according to claim 1, characterized in that in the housing (2) at least one magnetic element is arranged for navigation by means of a magnetic field which can be generated by an external magnet system.
14. Endoskopiekapsel nach Anspruch 1, dadurch gekennzeichnet, dass in dem Gehäuse (2) wenigstens ein Datenspeicher angeord- net ist.14. Endoscopy capsule according to claim 1, characterized in that in the housing (2) at least one data memory is arranged net.
15. Endoskopiekapsel nach Anspruch 1, dadurch gekennzeichnet, dass in dem Gehäuse (2) eine Auswerteelektronik angeordnet ist .15. endoscopy capsule according to claim 1, characterized in that in the housing (2) an evaluation is arranged.
16. Endoskopiekapsel nach Anspruch 1, dadurch gekennzeichnet, dass in dem Gehäuse (2) wenigstens eine Datenübertragungseinrichtung angeordnet ist. 16. Endoscopy capsule according to claim 1, characterized in that in the housing (2) at least one data transmission device is arranged.
17. Endoskopiekapsel nach einem der vorhergehenden Ansprüche, dadurch gekennzeichnet, dass in dem Gehäuse (2) wenigstens ein Energiespeicher angeordnet ist.17. Endoscopy capsule according to one of the preceding claims, characterized in that in the housing (2) at least one energy store is arranged.
18. Endoskopiekapsel nach Anspruch 17, dadurch gekennzeichnet, dass der Energiespeicher wiederaufladbar ist.18. Endoscopy capsule according to claim 17, characterized in that the energy store is rechargeable.
19. Endoskopiekapsel nach Anspruch 3, dadurch gekennzeichnet, dass das Frequenzspektrum der Wechselspannung Pulse in Form einer sinusförmigen Spannung umfasst.19. Endoscopy capsule according to claim 3, characterized in that the frequency spectrum of the AC voltage comprises pulses in the form of a sinusoidal voltage.
20. Endoskopiekapsel nach Anspruch 3, dadurch gekennzeichnet, dass das Frequenzspektrum der Wechselspannung Pulse in Form einer dreieckförmigen Spannung umfasst.20. Endoscopy capsule according to claim 3, characterized in that the frequency spectrum of the alternating voltage comprises pulses in the form of a triangular voltage.
21. Endoskopiekapsel nach Anspruch 3, dadurch gekennzeichnet, dass das Frequenzspektrum der Wechselspannung Pulse in Form einer sägezahnförmigen Spannung umfasst.21. Endoscopy capsule according to claim 3, characterized in that the frequency spectrum of the alternating voltage comprises pulses in the form of a sawtooth-shaped voltage.
22. Endoskopiekapsel nach Anspruch 3, dadurch gekennzeichnet, dass das Frequenzspektrum der Wechselspannung ein Rauschspektrum umfasst.22. Endoscopy capsule according to claim 3, characterized in that the frequency spectrum of the AC voltage comprises a noise spectrum.
23. Endoskopiekapsel nach Anspruch 3 oder einem der Ansprüche 19 bis 22, dadurch gekennzeichnet, dass das Frequenzspektrum der Wechselspannung wenigstens zwei Pulse verschiedener Formen umfasst.23. Endoscopy capsule according to claim 3 or one of claims 19 to 22, characterized in that the frequency spectrum of the AC voltage comprises at least two pulses of different shapes.
24. Endoskopiekapsel nach Anspruch 3 oder einem der Ansprüche 19 bis 23, dadurch gekennzeichnet, dass das Frequenzspektrum der Wechselspannung Anteile mit unterschiedlichen Bandbreiten aufweist .24. Endoscopy capsule according to claim 3 or one of claims 19 to 23, characterized in that the frequency spectrum of the AC voltage has portions with different bandwidths.
25. Endoskopiekapsel nach Anspruch 3 oder einem der Ansprüche 19 bis 24, dadurch gekennzeichnet, dass das Frequenzspektrum der Wechselspannung moduliert ist. 25. Endoscopy capsule according to claim 3 or one of claims 19 to 24, characterized in that the frequency spectrum of the AC voltage is modulated.
EP10704557A 2009-02-17 2010-02-15 Endoscopic capsule Withdrawn EP2398374A1 (en)

Applications Claiming Priority (4)

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DE102009009289A DE102009009289A1 (en) 2009-02-17 2009-02-17 Endoscopic capsule for treating patient's stomach illness caused by helicobacter pylori, has sensor comprising electrode made of precious metal and another electrode made of silver, where potential is measured between two electrodes
DE102009023038A DE102009023038A1 (en) 2009-05-28 2009-05-28 Endoscopic capsule for screening e.g. gastric acid of stomach lining for detecting Helicobacter pylori on patient, has sensor including electrodes, where change in electric variable is measured when ammonia is present between electrodes
DE102010006970A DE102010006970A1 (en) 2010-02-05 2010-02-05 Endoscopic capsule for screening e.g. gastric acid of stomach lining for detecting Helicobacter pylori on patient, has sensor including electrodes, where change in electric variable is measured when ammonia is present between electrodes
PCT/EP2010/051859 WO2010094652A1 (en) 2009-02-17 2010-02-15 Endoscopic capsule

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WO2010094652A1 (en) 2010-08-26
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MX2011008684A (en) 2011-09-06
US20110313266A1 (en) 2011-12-22
CN102316786A (en) 2012-01-11
US8918154B2 (en) 2014-12-23

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