WO2006131522A1

WO2006131522A1 - Device and method for diagnosis and/or treatment of functional gastrointestinal diseases

Info

Publication number: WO2006131522A1
Application number: PCT/EP2006/062941
Authority: WO
Inventors: Norbert Krauss; Rainer Kuth; Johannes Reinschke
Original assignee: Siemens Aktiengesellschaft
Priority date: 2005-06-10
Filing date: 2006-06-06
Publication date: 2006-12-14

Abstract

Device (1) for diagnosis and/or treatment of functional gastrointestinal diseases, which device can be swallowed by a patient and passes through the gastrointestinal tract, the device having an induced or permanent magnetic dipole moment (3) and being movable within the body of the patient by an external magnetic field or gradient field, and with a clip or gripper (4) for fixing the device at a desired location in the gastrointestinal tract, the clip or gripper (4) being designed with electrodes (7) for stimulating the intestinal wall.

Description

description

Device and method for the diagnosis and / or treatment of functional gastrointestinal diseases

The invention relates to a device for diagnosing and / or treating functional gastrointestinal diseases, which is swallowable by a patient and passes through the gastrointestinal tract, has an induced or permanent magnetic dipole moment and is movable by an external magnetic field or gradient field in the body of the patient wherein the device comprises a clip or gripper for fixing the device at a desired location in the body.

As functional disturbances or disorders of the gastrointestinal tract, especially the small intestine, such Erkrankun ^¬ gen are referred to in which no organic or physiological damage is present, which is obviously detectable by classical methods. The classical methods include blood tests, X-ray diagnostics, magnetic resonance diagnostics or ultrasound diagnostics. Functional diseases of the gastrointestinal tract are often diagnosed symptomatically by dysmotility. Among the Motili ^¬ tätsstörungen include irritable bowel syndrome, constipation, constipation, muscle contraction, crampy abdominal pain, irregular bowel movements or diarrhea. Other symptoms may include altered pH levels and altered electrolyte concentration in the intestinal secretions.

The diagnosis and treatment of gastrointestinal diseases in humans and mammals is difficult because the small intestine is virtually unreachable with conventional endoscopic methods.

WO 2004/014225 A2 describes a system and a method for observation and stimulation of gastrointestinal motility. For this purpose, one or more capsules are administered to the patient so that the capsules can be used for gastrointestinal administration. nal tract happen. Each capsule may contain a current-carrying coil that generates a magnetic dipole moment, alternatively, the capsule may contain a ferromagnet or an iron rod. An external sensing device is used to wirelessly detect the position and orientation of the swallowed capsules within the gastrointestinal tract. In addition, it is proposed to generate movements of the capsules by the external magnetic field in order to produce natural, physiological reflexes of the gastrointestinal tract. But it is questionable whether the mere movement of the capsule is already a Sti ^¬ mulation with a therapeutic effect.

From DE 103 36 734 Al shows a capsule that if a patient Navi magnetically in the interior of the body is gierbar just ^¬ and having a tissue anchor, which allows the anchoring of the capsule in the tissue wall in order in this way a position for a from outside to highlight leading surgical procedure. A driving device accelerates the tissue anchor. Since the surgical procedure is to be performed from the outside and with this procedure also the capsule is to be removed, there is no indication how the tissue anchor can be loosened otherwise from the tissue. Any thera ^¬ peutic effects should not be achieved with the device proposed here.

DE 10 2004 026 617 A1 and the corresponding patent application US 2005/0273139 A1, published on 29.12.05, improve the device according to DE 103 36 734 A1 in that, instead of the fabric anchor, a clip is now inserted secure jamming in the tissue made possible ^¬ light and which can be provided for tissue samples. The capsule can be released from the tissue in various ways and can thus be navigated out of the body again. In addition to tissue removal, the clip should also be used therapeutically insofar as it can be used to clamp wounds or bleeding inside the body. Further therapeutic Behandlun ^¬ gen are not disclosed. From the DE 10 2004 026 615 A1, published on 29.12.05 and the corresponding patent application US 2005/0267414 A1, magnetically navigable capsules are known inside the body which can be used for therapeutic treatment. The therapeutic agents are surface anlagerbar or to the tissue ^¬ carrying in the affected tissue ^¬ bar. As active agents, pharmaceuticals or radioactive lamps are proposed. Further therapeutic agents are not named, in particular the localization of the tissue to be treated is not described.

The patent application US 2004/01176664 A1 describes a capsule which can be inserted inside the body and which has extendable, extensible, movable arms in the form of trunks. The capsule should be able to be moved via the peristalsis or with the help of these cuspids. The trunk are hollow, have an elliptical cross-section and are finely segmented. They consist of a material which deforms with appropriate electrical current supply and moves back to the starting position when the current supply is switched off. About the segmented control all Be ^¬ movement directions should be executable. The arms have a tube through which, for example, liquids can be transported. These arms mimic or further wear medical instruments, sensors, clamps, blades, tissue, catheters, sampling devices, sensors, electrodes, etc. It should thus be able to perform any diagnostics and each therapeutically ^¬ diagram procedure. A precise configuration DIE ser arms, especially the equipment beyond the mere motion ^¬ possibility out, and the interaction of the various components and the way the diagnosis and therapy peutik is not disclosed. Overall, the pre schla ^¬ gene device and control of the arms has a complex.

The invention is therefore an object of the invention to provide a Vorrich ^¬ tion, the simple with very simple means allows improved diagnosis and stimulation of the gastrointestinal tract of a patient.

In order to solve this problem, it is provided according to the invention in a device of the type mentioned at the outset to design the clip or gripper in such a way that it likewise has electrodes as means for stimulating the intestinal wall. The clip or gripper makes it possible to fix the device at a desired location of the intestinal wall, so that it is not moved by the peristalsis in the direction of the intestinal exit. The inventive device thus allows the obser ^¬ processing and treatment of a specific site of the intestinal wall. According to the invention it is proposed to integrate the two electric ^¬ in the clip or gripper and electrical connections see to supply to the device. Through this stimulation via the electrodes can be specifically targeted to the intestinal wall to trigger a particular physiological response. Via the electrodes, an electric current can be delivered, which causes the desired irritation of the intestinal wall. The clip or gripper has to grip in the tissue ^¬ at least two jaws or half pliers, which are electrically isolated from each other and represent the electrodes. The electrical insulation can be done by appropriate coatings. It is expedient to contact the two jaws also in the closed state, ie without being in engagement with the tissue, to prevent, whereas in the rest of the jaw region is preferably provided on the cheek outer sides a good electrical contact with the tissue. In this way egg ne double function can quite easily the clip or gripper accomplished ^¬ to. Another advantage is that the contact of the electrodes with the tissue via the engagement of the clip or gripper inevitably comes to conditions. Additionally and in addition to the electrodes on the clip or gripper itself, it is also possible for electrodes to be attached to the periphery of the device.

Moreover, it can be provided in the device according to the invention that a further means for intestinal wall stimulation lation is used. This means is a medicament reservoir with a controllable outlet valve and / or an injection needle, wherein the reservoir ^¬ is filled with a pharmaceutical, which is selectively discharged inside the body by the outlet valve is actuated ^¬ taken. Here are many further developments conceivable, for example, several reservoirs can be provided for different drugs, as well as a Dos ^¬ siereinrichtung be provided to release a certain set dose.

When the device has a permanent magnetic dipole moment, such as by a permanent magnet disposed in the device, it can be moved to any desired position in the field by externally generated magnetic fields or gradient fields

Be navigated to the gastrointestinal tract. It is therefore ^¬ DERS particular advantageous if the clip or gripper of the device, wirelessly activatable, for example by a radio signal. Likewise, advantageously, the abovementioned means for stimulating the intestinal wall can also be activated in a wireless manner.

In order to allow addition to the pure therapeutic treatment across the intestinal stimulation means also an even further diagnosis, it may be envisaged that the device of the invention comprises at least one sensor can be received via the measuring values which are relevant in gastrointestinal disorders and we function of these measured values ^¬ at least one of the aforementioned means for stimulating the intestinal wall is activated. In this way beispielswei ^¬ can se before use of stimulant measurements are taken very local, which provide a treating physician important information for the diagnosis of functional disorders.

Advantageously, the measured values can be stored in a memory and / or read out wirelessly. In this way, the data can be made available for further evaluations. For example, diagnostic data with previous diagnosis Comparable sedates and trends, or it can be directly responded to the response of the therapeutic stimulation of the intestinal wall.

It is also conceivable that the means for intestinal wall stimulation can be activated as a function of the measured values which have been detected by at least one sensor. This activa ^¬ tion can be performed by a device disposed in the controller further, however, it is also possible that the measured values transferred to an external processing apparatus ^¬ the. The measured values the control signals are obtained by the processing then is transferred to the device which advises of the external Verarbeitungsge ^¬.

As already mentioned, the device according to the invention can have a sensor for acquiring measured values which are relevant for gastrointestinal diseases. For example, the sensor may be formed as a pressure sensor. This pressure sensor allows the measurement of the pressure in Gastrointestinal intestinal tract and the time profile of the pressure. This pressure values and the pressure curve allowing the physician Di ^¬ agnosen to provide and determine the setpoints for the stimulation stimulate the intestinal wall. However, these setpoints can also be determined automatically by an internal or external processing and control unit. As an ^alternative or supplement, the device should further comprise one or more pH sensors which measure the pH of the intestinal secretion and thus provide diagnostic data. Alternatively or additionally, a sensor for measuring the electrolyte concentration can be provided.

In addition, the invention relates to a method for the diagnosis and / or treatment of functional gastrointestinal diseases, comprising the following steps:

- Ingestion of a device having an induced or permanent magnetic dipole moment and by an external magnetic field or gradient field is movable in the body; by a patient;

- Navigate the device in the area to be examined;

- fixing the device in the gastrointestinal tract;

optionally acquiring measured values by means of a sensor arranged in the device.

- Stimulation of the intestinal wall

The inventive method has the advantage that an inadvertent displacement or unwanted movement of the device is prevented by the peristalsis, since the device is fixable in the gastrointestinal tract and a direct electrical stimulation of the intestinal wall, on the clip or gripper is enabled. To generate certain stimuli and to stimulate the intestinal wall, electrical impulses are delivered via the electrodes.

The electrical stimulation is already successful for many applications ^¬ cases. In the event that no data Example ^¬, from preliminary studies are present, still measured values can be detected by a sensor arranged in the device prior to stimulation.

In the method according to the invention it can be provided that the pressure in the gastrointestinal tract and, if appropriate, its time course are measured. In addition, alternatively or additionally, the electrolyte concentration and / or the pH of the intestinal secretion can be measured.

It is also possible to achieve stimulation by at least one drug via an exhaust valve of the Vorrich ^¬ tung is released, acts on the intestinal wall. In the method according to the invention, measured values can be stored in a memory, but preferably the recorded measured values are simultaneously transmitted to an external receiving device.

The method according to the invention has the advantage that it is non-invasive, does not cause radiation exposure and is fast due to magnetic navigation. Because of the local therapy, possible side effects are reduced to a minimum.

Further advantages and details of the invention will be explained with reference to a particularly preferred embodiment with reference ^¬ measure on the figures. The figures are schematic representations and show:

1 shows a device according to the invention in a ge ^¬ cut view.

Fig. 2 shows a section of the device according to the invention concerning the gripper and

Fig. 3, the introduced into the body of a patient device.

The device 1 shown in Fig. 1 is formed kapseiförmig and comprises a shell 2, is located in which a Perma ^¬ nentmagnet. 3 The arrows indicate the magnetization ^¬ direction of the permanent magnet 3. When the permanent magnet 3 passes with an external magnetic field or gradient field in Wech ^¬ selwirkung, forces and moments acting on the Vorrich ^¬ a device 1, the device 1 so moved. The targeted generation of the external magnetic fields, the device 1 can be moved to any desired location in the gastrointestinal tract of a patient and navigated.

When the desired examination or treatment area it is sufficient ^¬, a gripper can 4 of the device 1 is extended be to fix the device at this point. The fixation prevents the device 1 from being moved by the peristalsis of the intestine. At the Grei ^¬ fer 4 electrodes 7 are formed, which are electrically connected to the device 1 and driven cause an electrical Sti ^¬ mulation of the tissue with which the gripper 4 is engaged.

By means of a pressure sensor 5 integrated in the device 1, the pressure acting at this point can be measured in the gastrointestinal tract. In addition, a data transmission device 6 is provided in the device 1, the measurement data, such as the data of the pressure sensor 5, can be transmitted to an external device, at the same time the data transmission device 6 can receive data from the external device, the

Example, control signals may include. These may be signals for extending or retracting the gripper 4, as well as a measured value can be requested from the pressure sensor 5. The entire communication of the device 1 with the external device takes place via the data transmission device 6.

In addition to the pressure sensor 5, a sensor 8 for measuring the pH value is present, with a further sensor, the electrolyte concentration can be measured. In other embodiments, additional sensors for the detection of drugs or endogenous messengers may be present.

The device 1 comprises further electrodes 7 which are mounted on the outside of the device 1 in the circumferential direction and in the longitudinal direction spaced from each other. This Kgs ^¬ NEN be used in support when the electrodes 7 rest against a tissue wall. An electric current can be applied, which then exerts a stimulus on the intestinal wall. A medicament reservoir 12 is located in the device 1, which is filled with one or more medicaments. The medicaments may be powdery, capsular or liquid, for example, and may be opened a non-illustrated flap of the reservoir 12 are administered controlled. The capsular Vorrich ^¬ device 1 further comprises an injection needle 11, which is received in a cavity 9 and connected to a supply of medicaments, not shown. By extending the injection needle 11 from the cavity 9, the drug can be applied to the tissue of the intestinal wall. At a Stirnsei ^¬ te of the device 1 is disposed an optical dome 13, a camera located behind the fourteenth

FIG. 2 shows a detail of the device 1 shown in FIG. 1. In this illustration, the gripper 4 has been moved out of the device 1. The gripper 4 consists essentially of the two jaws 17a and 17b and a shaft 18. The jaws 17a, 17b and the connection to the

Device 1 producing shaft 18 are electrically conductive, wherein the surface of the shaft 18 itself may be isolated. The shank 18 is divided into two parts, in that it can supply the upper jaws 17a and the lower jaws 17b separately from each other via an insulating layer 16. The jaws 17a, 17b have a further insulation 16, which prevents electrical contact of the upper jaw 17a and the un ^¬ direct baking 17b in the space provided for the tissue engaging tip. On the outside of the jaws 17a, 17b, these have a region of the respective electrodes 7, via which a stimulation of the tissue region can be carried out.

Fig. 3 shows the device 1 after insertion into the body of a patient. The patient 10 ingests the ^device 1, which is then rapidly brought into the examination or treatment area by magnetic navigation. The patient lies in a coil system, which is needed to produce the external magnetic fields, beispiels-, in the schematically illustrated tube 15. It is typically not administered a muscle relaxant, because the na ^¬ ral peristaltic movement to be examined. When the device 1 is placed in the desired location in the gastrointestinal tract, nal tract is reached, it is fixed with the gripper 4 and the engaged electrodes 7 can be electrically controlled for stimulation. Before or during the stimulation, the time course of the pressure is measured. If the intestinal wall stimulates the changed by the Stimu ^¬ lation pressure curve is represented on an external display device. In addition to the pressure further measurement values, such as the pH of the intestinal secretion or Elektrolytkonzentra ^¬ tion are measured and displayed. If the stimulation was insufficient, the dose may be increased, to which end the further electrodes 7 may have to be inserted or the stimulation pharmaceuticals may be administered from the medication reservoir 12 or the patient may be another capsular device which is another means for intestinal wall stimulation. Then the be ^¬ prescribed procedure is repeated. The activation of the various stimulation means takes place in dependence on the acquired measured values, that is, there is a feedback. This automatic feedback either takes place capsule-internally or the required control signals are transmitted from the external device or an external processing device to the device.

Claims

claims

1. Device (1) for the diagnosis and / or treatment of functional gastrointestinal diseases, which is swallowed by a patient and passes through the gastrointestinal tract, an induced or permanent magnetic dipole moment (3) and by an external magnetic field or gradient ^¬ field in the body the device is movable, wherein the device has a clip or gripper (4) for fixing the device (1) at a desired location in the body, characterized in that the clip or gripper (4) is designed such that it ^electrodes ( 7) as a means of stimulating the intestinal wall.

2. Device according to claim 1, characterized in that the device (1) further comprises a medicament reservoir (12), optionally with a controllable outlet valve and / or an injection needle (11) as a means for stimulating the intestinal wall.

3. A device according to claim 1 or 2, wherein a clip or gripper

(4) and / or the means (7, 11, 12) for the stimulation of the intestinal wall are wirelessly activated.

4. Device according to one of the preceding claims, characterized in that the device (1) has at least one sensor (5, 8), can be recorded on the measured values and in dependence thereon

Measured values at least one means (7, 11, 12) for stimulating the intestinal wall is activated.

5. Apparatus according to claim 4, characterized in that measured values can be stored in a memory and / or can be read out wirelessly.

6. Device according to one of the preceding claims, characterized in that we ^¬ least one means (7, 11, 12) for stimulation of the intestinal wall by a in the device (1) arranged control is aktibbar.

7. Device according to one of claims 4 to 6, characterized in that the measured values can be transmitted to an external processing device and at least one means (7, 11, 12) for intestinal wall stimulation can be activated wirelessly via control signals of the external processing device.

8. Device according to one of the claims 4 to 7, wherein a sensor is designed as a pressure sensor (5) and / or pH value sensor (8) and / or sensor for measuring the electrolyte concentration.

9. A method for the diagnosis and / or treatment of functional gastrointestinal diseases, comprising the following steps:

Swallowing a device which has an induced or permanent magnetic dipole moment and is movable by an external magnetic field or gradient field in the body; by a patient;

- Navigate the device in the area to be examined;

- fixing the device in the gastrointestinal tract;

- Stimulation of the intestinal wall

10. The method according to claim 9, wherein a pressure is measured in the gastrointestinal tract and, if appropriate, its time course is measured.

11. The method according to claim 9 or 10, characterized in that the Elektrolytkonzent ^¬ ration and / or the pH of the intestinal secretion are measured.

12. The method according to claim 9, wherein measured values are stored in a memory and / or transmitted wirelessly to an external receiving device.

13. The method of claim 9, wherein the intestinal wall is stimulated by a preferably wirelessly activatable means for intestinal wall stimulation.

14. A method according to claim 13, wherein the intestinal wall is electrically stimulated by means of electrodes.

15. The method of claim 13 or 14, wherein a stimulation of the bowel wall actuates an outlet valve of the device and a medicament is released.

16. Method according to one of claims 12 to 15, characterized in that the means for intestinal wall stimulation is activated as a function of the measured values detected by the at least one sensor.

17. The method according to any one of claims 12 to 16, characterized in that the means for intestinal wall stimulation is activated by an arranged in the device control.

18. The method according to any one of claims 12 to 16, characterized in that the measured values transferred to an external processing apparatus who will ^¬ and the means for intestinal wall stimulation based on obtained from the processed measurement values control signals enabled.