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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• General Health & Medical Sciences (AREA)
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Applications Claiming Priority (4)

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• 2010
  • 2010-02-15 MX MX2011008684A patent/MX2011008684A/es not_active Application Discontinuation
  • 2010-02-15 JP JP2011549589A patent/JP5404817B2/ja not_active Expired - Fee Related
  • 2010-02-15 BR BRPI1008932A patent/BRPI1008932A2/pt not_active IP Right Cessation
  • 2010-02-15 WO PCT/EP2010/051859 patent/WO2010094652A1/de active Application Filing
  • 2010-02-15 CN CN2010800081206A patent/CN102316786A/zh active Pending
  • 2010-02-15 EP EP10704557A patent/EP2398374A1/de not_active Withdrawn
  • 2010-02-15 US US13/148,533 patent/US8918154B2/en not_active Expired - Fee Related

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