MEDICAL SYSTEM FOR PERFORMING A THERAPEUTIC FUNCTION ON A PATIENT

Abstract

A medical system for performing a therapeutic function on a patient comprises an implantable medical device having a switching function to switch from a normal operating mode to an MRI compatible operating mode in the presence of an MRI device, and an external device for programming at least one setting of the implantable medical device. The external device is configured, based on a programming event relating to said at least one setting, to generate a notification prompting a user to confirm a continuing MRI compatibility of said MRI compatible operating mode after the programming event and/or to amend said at least one setting for achieving MRI compatibility.

Claims

1. A medical system, the system comprising: an implantable medical device having a switching function to switch from a normal operating mode to an MRI compatible operating mode in the presence of an MRI device; and an external device for programming at least one setting of the implantable medical device; wherein the external device is configured, based on a programming event relating to said at least one setting, to generate a notification prompting a user to confirm a continuing MRI compatibility of said MRI compatible operating mode after the programming event and/or to amend said at least one setting for achieving MRI compatibility.

2. The medical system of claim 1, wherein the external device comprises a display device for visually outputting said notification.

3. The medical system of claim 1, wherein the programming event relates to a change in a hardware configuration of the implantable medical device.

4. The medical system of claim 1, wherein the programming event relates to a change in a software configuration of the implantable medical device.

5. The medical system of claim 1, wherein the programming event relates to a change in a setting of a therapeutic function or a diagnostic function of the implantable medical device.

6. The medical system of claim 1, wherein the external device is configured to effect said at least one setting of the implantable medical device only if said continuing MRI compatibility of said MRI compatible operating mode is confirmed by a user in reaction to said notification.

7. The medical system of claim 1, wherein the external device configured to generate said notification only if said switching function is enabled for switching from said normal operating mode to said MRI compatible operating mode in the presence of an MRI device.

8. The medical system of claim 1, wherein the implantable medical device comprises a sensing device for sensing a measurement quantity indicative of a presence of an MRI device, and a processing device for controlling operation of the implantable medical device and for identifying a presence of an MRI device based on measurement values obtained from the sensing device.

9. The medical system of claim 8, wherein the implantable medical device comprises a program memory configured to store at least one program routine for operating the implantable medical device in said MRI compatible operating mode, wherein the processing device is configured to switch to said at least one program routine for controlling operation of the implantable medical device in the presence of an MRI device.

10. The medical system of claim 9, wherein said at least one program routine represents an OFF mode in which a stimulation function is switched off.

11. The medical system of claim 9, wherein said at least one program routine represents an asynchronous mode employing an asynchronous stimulation.

12. An external device operative in a medical system, the external device being configured to program at least one setting of an implantable medical device which has a switching function to switch from a normal operating mode to an MRI compatible operating mode in the presence of an MRI device; wherein the external device is configured, based on a programming event relating to said at least one setting, to generate a notification prompting a user to confirm a continuing MRI compatibility of said MRI compatible operating mode after the programming event and/or to amend said at least one setting for achieving MRI compatibility.

13. A method for operating a medical system, comprising: programming at least one setting of an implantable medical device using an external device, the implantable medical device having a switching function to switch from a normal operating mode to an MRI compatible operating mode in the presence of an MRI device; wherein generating, using the external device and based on a programming event relating to said at least one setting, a notification prompting a user to confirm a continuing MRI compatibility of said MRI compatible operating mode after the programming event and/or to amend said at least one setting for achieving MRI compatibility.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0049] Various features and advantages of the present invention may be more readily understood with reference to the following detailed description and the embodiments shown in the drawings. Herein,

[0050] FIG. 1 shows a schematic illustration of an implantable medical device in a patient;

[0051] FIG. 2 shows a schematic drawing of an MRI device;

[0052] FIG. 3 shows a schematic drawing of an implantable medical device;

[0053] FIG. 4 shows a schematic drawing of preparatory steps for conducting an MRI examination on a patient carrying an implantable medical device such as a pacemaker device;

[0054] FIG. 5 shows a schematic drawing of an implantable medical device being configured for adapting operation in case of a presence of an MRI device; and

[0055] FIG. 6 a schematic view of a menu as displayed on a display device.

DETAILED DESCRIPTION

[0056] Subsequently, embodiments of the present invention shall be described in detail with reference to the drawings. In the drawings, like reference numerals shall designate functionally similar structural elements, if appropriate.

[0057] It is to be noted that the embodiments are not limiting for the present invention, but merely represent illustrative examples.

[0058] FIG. 1 shows a schematic illustration of an implantable medical device 1, for example, in the shape of a stimulation device, such as a pacing device or a defibrillation device. The implantable medical device 1 may, for example, comprise a generator 10 which, for example, as illustrated in FIG. 1, may be subcutaneously implanted into a patient, wherein an electrode 11 is connected to the generator 10 and extends from the generator 10 towards a region of interest, for example, the patient's heart, such that a therapy function may be provided at the region of interest, for example, in the patient's heart.

[0059] An implantable medical device 1 of this kind may, for example, be configured to provide a therapy function over a prolonged period of time, for example, a pacing function or a defibrillator function. The implantable medical device 1, for this, may be permanently implanted into a patient P and may function in a substantially autarkic manner, wherein a communication connection may be established with the implantable medical device 1 using an external device 2, for example, to program the implantable medical device 1 or to transfer, using, for example, telemetry, data from the implantable medical device 1 to the external device 2.

[0060] An external device 2 may communicate with the implantable medical device 1 using electromagnetic means, for example, by establishing an inductive coupling in between the implantable medical device 1 and the external device 2.

[0061] If, as schematically illustrated in FIG. 2, a patient P shall undergo an MRI examination using an MRI device 3, the patient P, carrying an implantable medical device 1, is introduced into a bore 30 of the MRI device 3 by placing the patient P on a patient bed 31 and by continuously moving, using an electro-motoric drive of the patient bed 31, the patient P into the bore 30 in a movement direction V. When moving the patient P into the bore 30 of the MRI device 3, the patient P herein is brought into the range of a constant magnetic field M of the MRI device 3, the magnetic field M generally having a maximum magnetic field strength (corresponding to the magnetic flux density B and indicated usually in Tesla [T]) within the bore 30. Hence, when the patient P is moved into the bore 30 of the MRI device 3, the magnetic field strength of the magnetic field M at the location of the implantable medical device 1 will steadily increase.

[0062] Caused by a magnetic field M of an MRI device 3 electrical signals may be induced within an implantable medical device 1. Hence, it shall be detected if an implantable medical device 1 comes into the range of an MRI device 3, such that operation of the implantable medical device 1 can suitably be modified in order to avoid a disturbance of operation by the MRI device 3.

[0063] FIG. 3 illustrates an embodiment of a generator 10 of an implantable medical device 1, for example, in the shape of a stimulation device such as a pacemaker device or a defibrillator device. Included in a housing of the generator device 10 is a processing device 101, implemented, e.g., by electronic circuitry on a circuit board, which serves to control operation of the generator 10 for transmission of electrical stimulation energy via the electrodes 11 connected to a connector block 100 of the generator 10, and for analyzing sense signals received, e.g., via the electrodes 11 to provide for a therapy aligned to an activity of, for example, the patient's heart.

[0064] The generator 10 further comprises an energy storage 102 in the shape of a battery, a sensing device 103, for example, in the shape of a GMR sensor for sensing magnetic fields, and a communication device 104 for establishing a communication connection, for example, to an external device 2, as illustrated in FIG. 1.

[0065] The sensing device 103 is connected to the processing device 101 and is configured to conduct measurements yielding measurement values indicative of a magnetic field strength at the location of the sensing device 103. The sensing device 103 may, for example, be configured to conduct measurements at a specified sampling rate, for example, at a rate in between 1 Hz and 50 Hz, for example, 4 Hz. The sensing device 103 provides (discrete) measurement values to the processing device 101, which are analyzed by the processing device 101 and are used to identify the presence of an MRI device 3.

[0066] Referring now to FIG. 4, if a patient P carrying an implantable medical device 1 (for example, in the shape of a pacemaker device, such as a CRT device) has to undergo an MRI examination, the patient P typically has to visit a physician C such that the physician C may adapt operation of the implantable medical device 1 in order to avoid a malfunction of the implantable medical device 1 during MRI examination (steps A1, A2 in FIG. 4). In the course of adaption, for example, an MRI compatible operating mode is enabled in which a stimulation function of the implantable medical device 1 is switched off, or in which the stimulation function is adapted such that the implantable medical device 1 may safely operate in the presence of electromagnetic fields as caused by an MRI device 3.

[0067] Such adaption of the configuration of the implantable medical device 1 should take place within a rather short time range prior to the MRI examination, for example, within 14 days prior to the MRI examination. The patient P may then undergo the MRI examination (steps A3, A4), wherein the MRI compatible operating mode is activated once the presence of the MRI device 3 is detected by the implantable medical device such that during the MRI examination the implantable medical device operates according to its modified, MRI compatible operating mode. Subsequent to the MRI examination data may be reported to a home monitoring system 4 (steps A5, A6), and the implantable medical device 1 may switch back to resume normal operation.

[0068] In a conventional scenario, a patient P hence must visit a physician C prior to an MRI examination, which must suitably configure the implantable medical device 1 in order to enable an operation which is adapted to a potential interaction with electromagnetic fields of an MRI device 3.

[0069] Referring now to FIG. 5, an implantable medical device 1 may be adapted for an automatic selection of configuration if a presence of an MRI device 3 is detected based on measurement data obtained from a sensing device 103.

[0070] The implantable medical device 1, as shown in FIG. 5, comprises a processing device 101 which controls operation of the implantable medical device 1, in particular to control a stimulation module 105 configured to transmit stimulation energy towards electrodes 11 attached to a generator portion 10 of the implantable medical device 1 and to receive sensing data from the electrodes 11. For example, in one embodiment the implantable medical device 1 may be configured to provide for an anti-bradycardia stimulation, for which a therapeutic function is triggered once a bradycardia is detected in order to provide for a pacing counteracting the bradycardia.

[0071] Generally, in a default, normal operating mode the processing device 101 may, for example, provide for a stimulation based on sensed measurement data, in order to, for example, provide a stimulation in a synchronous fashion in synchronicity and triggered by sensed activity. For example, in a normal operating mode the processing device may be configured to operate in a so-called VVI mode, relating, for example, to a ventricular anti-bradycardia pacing, or a DDD mode, relating, for example, to a dual-chamber anti-bradycardia pacing.

[0072] In case the processing device 101 identifies, based on measurement data obtained from a sensing device 103 (such as a GMR sensor for measuring a magnetic field strength at the location of the implantable medical device 1) the presence of an MRI device 3, the processing device 101 is configured to automatically adapt operation of the implantable medical device 1 in that the processing device 101 switches to an MRI compatible operating mode. For this, the processing device 101 switches to a program routine R1, R2, which is stored in a program memory 106 and implements an MRI compatible operating mode in that it provides for a suitable operation of the implantable medical device 1 in the presence of electromagnetic fields of an MRI device 3. In particular, by means of the program routine R1, R2 it is made sure that malfunctions due to interaction with electromagnetic fields of the MRI device 3 are avoided.

[0073] In the program memory 106, different program routines R1, R2 may be stored, which provide for different MR compatible operating modes. Herein, the processing device 101 may be configured to select one of the program routines R1, R2 based on an analysis of information, e.g., of a patient's condition, e.g., a history of heart rate information, as stored in a memory 107.

[0074] A program routine R1, R2 may, for example, represent an OFF mode in which a stimulation function is switched off, such that, if the implantable medical device 1 is operated according to the particular program routines R1, R2, no stimulation takes place once the patient P is in the vicinity of an MRI device 3.

[0075] Another program routine R1, R2 may represent an asynchronous mode in which a stimulation takes place, but in an asynchronous fashion, i.e., without sensing data and without basing a stimulation, such as a pacing action, on sensed data. The asynchronous mode may, for example, be a VOO or a DOO mode.

[0076] The switching to a program routine R1, R2 takes place once the processing device 101, based on readings of the sensing device 103, identifies the presence of an MRI device 3. The sensing device 103 herein may, for example, be configured to measure a magnetic field strength for identifying, for example, a rise of the magnetic field strength. Alternatively, the sensing device 103 may be adapted to measure a gradient field vector, an RF field, a position, a vibration, or a characteristic electrical signal pattern as, for example, induced on the electrodes 11. Multiple sensors measuring different measurement quantities may be used in combination.

[0077] Once the processing device 101 identifies that the patient P no longer is in the presence of an MRI device 3, the processing device 101 switches back to the normal operating mode, by, for example, switching on a stimulation function or switching to a synchronous mode.

[0078] By means of the processing device 101, hence, an automatic switching of operation to a program routine R1, R2 which is suitable for use during an MRI examination is provided. This makes it possible for a patient P to undergo an MRI examination without specific preparation, in particular without having to visit a physician C (as shown in FIG. 4) for the purpose of configuring the implantable medical device 1 prior to undergoing the MRI examination. The burden for the patient P hence is reduced, while at the same time saving time and costs.

[0079] Referring now again to FIG. 1, the external device 2 may be used to change settings of the implantable medical device 1, such that operation of the implantable medical device 1 may be modified according to a programming of settings using the external device 2. A change of settings herein may take place in order to adapt a certain function of the implantable medical device 1, for example, to switch on or off a defibrillation function or an ATP function, or to switch from a synchronous stimulation mode to an asynchronous stimulation mode or vice versa.

[0080] In addition, a change of settings may take place if a hardware configuration of the implantable medical device 1 changes, for example, if an electrode 11 is invasively added to or removed from the implantable medical device 1, making it necessary to adapt the operation of the implantable medical device 1 to ensure a proper operation according to the modified hardware configuration of the implantable medical device 1.

[0081] A change in settings using the external device 2 may, for example, take place using an input device 20, for example, in the shape of a keyboard, and a display device 21, which may be connected to the external device 2 or may be an integral part of the external device 2. Via the input device 20 and the display device 21, for example, a menu 210 as shown in FIG. 6 may be accessed, wherein via the menu 210 different settings relating to different categories, in particular relating to a hardware configuration and a software configuration, may be accessed and modified, wherein a change in settings on the user interface of the external device 2 shall cause a corresponding change in settings in the implantable medical device 1.

[0082] If one or multiple settings are changed in a programming event on the external device 2, this may also affect the MRI compatibility of the MRI compatible operating mode. Hence, in case of a programming event in which one or multiple settings are changed on the external device 2, a notification 211, for example, in the shape of an output message is displayed on the display device 21, the notification 211 prompting the user to confirm a continuing MRI compatibility of the MRI compatible operating mode even with the new settings.

[0083] Hence, the user is required to enter a confirmation by which it is confirmed that even after the programming event and the corresponding change in settings the MRI compatible operating mode remains MRI compatible. The external device 2 herein may be configured such that the change in settings is transferred to and activated on the implantable medical device 1 if and only if the user enters the confirmation.

[0084] By means of the notification 211 the user may be asked to input a confirmation confirming the continuing MRI compatibility of the MRI compatible operating mode, or otherwise to again change the settings and then confirm MRI compatibility, or to revert to the old settings. The notification 211 herein may be displayed until a confirmation is entered, such that the user is forced to react to the notification 211 in order to activate a change in settings on the implantable medical device 1.

[0085] A notification 211 may be displayed visually on the display device 21, or acoustically as an acoustic message. In addition or alternatively, a message may be communicated to another (remote) system, or may be printed out together with a data report or the like.

[0086] By generating and displaying the notification 211 in the event of programming settings using the external device 2, it is made sure that MRI compatibility of the implantable medical device 1 is checked and ensured, hence improving reliability of operation and easing due care during a programming of settings of an implantable medical device 1.

[0087] It will be apparent to those skilled in the art that numerous modifications and variations of the described examples and embodiments are possible in light of the above teachings of the disclosure. The disclosed examples and embodiments are presented for purposes of illustration only. Other alternate embodiments may include some or all of the features disclosed herein. Therefore, it is the intent to cover all such modifications and alternate embodiments as may come within the true scope of this invention, which is to be given the full breadth thereof. Additionally, the disclosure of a range of values is a disclosure of every numerical value within that range, including the end points.

LIST OF REFERENCE NUMERALS

[0088] 1 Implantable medical device (pacemaker device) [0089] 10 Generator [0090] 100 Connector block [0091] 101 Processing device [0092] 102 Energy storage [0093] 103 Sensing device [0094] 104 Communication module [0095] 105 Stimulation module [0096] 106 Program memory [0097] 107 Memory [0098] 11 Electrode [0099] 2 External device [0100] 20 Input device [0101] 21 Display device [0102] 210 Menu [0103] 211 Notification (prompt message) [0104] 3 MRI device [0105] 30 Bore [0106] 31 Patient bed [0107] 4 Home monitoring system [0108] A1-A6 Steps [0109] C Clinician [0110] M Magnetic field (magnetic flux density) [0111] P Patient [0112] R1, R2 Program routine [0113] V Moving direction