Systems and methods for commanding a medical device configured to be implanted - Patents.com

Abstract

The present invention relates to a method and a command system (1) for remotely commanding a medical device (2) configured to be implanted in a human or animal body, the command system comprising at least a first activation element (4) and a second activation element (5) for commanding the medical device, the first activation element being configured to be triggered by proximity to an additional activation element (6) and the second activation element being configured to be triggered by pressure applied to the second activation element, the command system being configured to activate a command of the medical device after triggering of the first activation element and the second activation element.

Description

[Technical Field]

[0001] The present invention relates to a system for commanding implantable medical devices in a human or animal body.

[0002] The present invention particularly relates to actively implantable medical devices, ie medical devices that depend for their operation on a source of electrical energy and that need to have an adapted command system. [Background technology]

[0003] For example, there are many medical devices that can be implanted into a patient to perform functions within the patient's body to compensate for the malfunctioning of natural organs.

[0004] In particular, implantable medical devices are known for selectively sealing anatomical ducts, for example to treat incontinence (in the case of artificial urinary and anal sphincters) or to restrict the entry of food into the stomach (in the case of gastric bands). Sealing of the anatomical duct is typically caused by compression of a cuff wrapped around the duct.

[0005] Generally speaking, the artificial urinary sphincter includes an occlusion cuff that is implanted around the urethra, and possibly around the bladder neck in the case of female implants, or around the prostate in the case of male implants, to compress the urethra to prevent urinary leakage, particularly in patients suffering from incontinence. A command system configured to activate commands of the artificial sphincter, for example, to adjust the compression applied by the cuff to seal or open the natural duct, is also provided.

[0006] In older artificial sphincters, the medical device is configured so that manual actuation by the patient, for example, pressure applied to a pump device placed under the skin, activates the artificial sphincter's commands.

[0007] Today, more sophisticated systems have been developed to avoid the patient having to manually pump to control the cuff.

[0008] The artificial sphincter then includes a remote command system not implanted in the patient's body that is adapted to activate commands of the implanted medical device, for example, by realizing a reduction in the pressure exerted on the natural duct by the cuff.

[0009] Currently, there are different types of implanted medical devices that can be remotely activated by command systems that are not implanted within the patient's body, such as artificial urinary sphincters that implement different cuff technologies (hydraulic, mechanical, inflatable, etc.) and different piezoelectric actuator technologies, cables, etc.

[0010] It is understood that the present invention is not limited to any particular implanted medical device technology.

[0011] However, implanted medical devices that can be remotely activated by a command system that is not implanted in the patient's body have the disadvantage that they can be accidentally, i.e., unintentionally, activated by the patient. This is usually the case when the command system is accidentally operated, for example, when the command system is in the form of a remote command having a button that triggers activation of a command of the implanted medical device, and this remote command is placed in the patient's pants pocket. In this case, a simple change in the patient's posture can result in unintentional pressure on the remote command button and thus activation of a command of the medical device, for example, a reduction in pressure in the cuff and unintentional urination by the patient.

[0012] These conditions create a very difficult situation for the patient. Therefore, there is a need for a system for remotely commanding implanted medical devices that avoids unintended commands. Summary of the Invention [Problem to be solved by the invention]

[0013] The present invention therefore aims to overcome these drawbacks by providing a system for remotely commanding medical devices implanted in the body of a human or animal, which activates commands only as a result of the patient's intentional action. [Means for solving the problem]

[0014] To achieve this object, the present invention provides a command system for remotely commanding a medical device configured to be implanted in a human or animal body, the command system including at least a first activation element and a second activation element for commanding the medical device, the first activation element configured to be triggered by proximity to an additional activation element, and the second activation element configured to be triggered by pressure applied to the second activation element, and the command system configured to activate a command of the medical device after triggering of the first activation element and the second activation element.

[0015] The present invention therefore relates to a command system that is not implanted within a patient's body, capable of remotely commanding a medical device that is implanted within the human or animal body, where implantation is understood to refer to a medical device that is introduced into the human or animal body, for example during a surgical procedure.

[0016] It should be noted that advantageously, activation of commands of an implanted medical device by triggering two activation elements of different natures allows for a significant reduction in unintentional activation of commands by the patient.

[0017] According to one embodiment of the invention, the command system is configured to activate a command of the medical device after simultaneous triggering of the first activation element and the second activation element, while according to another embodiment, the command system is configured to activate a command of the medical device after sequential triggering of the first activation element and the second activation element, preferably in a time interval of less than 1 second, preferably less than 500 milliseconds, and more preferably less than or equal to 100 milliseconds.

[0018] According to one particular embodiment of the present invention, the first activation element and the second activation element are arranged in different locations of the command system, preferably on either side of the command system, whereas according to another embodiment, the first activation element and the second activation element are arranged in the same location of the command system so as to overlap.

[0019] According to one embodiment of the present invention, the first activation element comprises a sensor selected from the group consisting of a tactile sensor, a resistive sensor, a capacitive sensor, an inductive sensor, an infrared sensor, an optical sensor, a magnetic sensor or a fingerprint recognition sensor, preferably configured to recognize at least a first consecutive fingerprint for activating a first command of the medical device and at least a second consecutive fingerprint for activating a second command of the medical device, the first command being different from said second command.

[0020] According to one embodiment of the invention, the additional activation element is separate from the command system and consists of a part of the human or animal body, preferably a finger, a stylus or badge or clip, in particular a magnetic or electromagnetic stylus or badge or clip.

[0021] According to another embodiment of the invention, the first activation element is configured to be triggered by proximity to an additional activation element at a distance of less than 5 millimeters, preferably less than 1 millimeter. Alternatively, the first activation element is configured to be triggered by contact with the additional activation element.

[0022] In one particular embodiment of the invention, the second activation element includes a state-change sensor that measures a change in state under the effect of pressure applied to the second activation element that causes movement of at least a portion of the second activation element, the second activation element being selected from the group consisting of a push button, a switch, and an electrical switch.

[0023] According to another embodiment of the invention, the triggering of the second activation element is configured to switch on the command system, which avoids keeping the command system in power-consuming standby for a long period of time.

[0024] Preferably, the command system is configured to remotely activate commands for the medical device. That is, the command system is positioned outside or without contact with the human or animal body. It will be appreciated that the command system should not and is not implanted within the human or animal body. Thus, the command system includes at least one radio frequency transmitter configured to communicate wirelessly with the medical device, the radio frequency transmitter configured to be paired with a radio frequency receiver of the medical device prior to activation of commands for the medical device by the command system.

[0025] According to one particular embodiment of the present invention, the command system includes a display that indicates activation of commands of the medical device by the command system.

[0026] Preferably, the command system is configured to command a medical device to occlude a natural duct in the human or animal body, the medical device being configured to command a medical device selected from the group consisting of an artificial sphincter, an artificial muscle, an electrical stimulator, a gastric ring, a neurostimulator or a penile implant.

[0027] The present invention extends to medical equipment, including a command system as defined above and a medical device adapted to be implanted in the human or animal body.

[0028] The present invention extends to a method for remotely commanding a medical device configured to be implanted within a human or animal body, the method comprising: - providing a command system including at least a first activation element and a second activation element for remotely commanding a medical device, the first activation element being triggered by proximity to an additional activation element and the second activation element being triggered by pressure applied to the second activation element; - activating a command of the medical device after triggering a first activation element and a second activation element of the command system.

[0029] In one embodiment of the method according to the invention, the command system activates a command of the medical device after simultaneous triggering of the first activation element and the second activation element, while according to another embodiment, the command system activates a command of the medical device after successive triggering of the first activation element and the second activation element, preferably with a time interval of less than 1 second, preferably less than 500 milliseconds, and more preferably less than 100 milliseconds.

[0030] According to one particular embodiment of the method, the first activation element and the second activation element are located at different locations on the command system, preferably on opposite sides of the command system, whereas according to another embodiment, the first activation element and the second activation element are located at the same location on the command system.

[0031] According to another embodiment of the method, the first activation element comprises a sensor selected from the group consisting of a tactile sensor, a resistive sensor, a capacitive sensor, an inductive sensor, an infrared sensor, an optical sensor, a magnetic sensor or a fingerprint recognition sensor. Preferably, the fingerprint recognition sensor recognizes at least a first consecutive fingerprint for activating a first command of the medical device and at least a second consecutive fingerprint for activating a second command of the medical device, the first command being different from the second command.

[0032] According to yet another embodiment of the method, the additional activation element is provided separately from the command system and consists of a part of the human or animal body, preferably a finger, a stylus or badge or chip, in particular a magnetic or electromagnetic stylus or badge or chip.

[0033] According to one embodiment of the method, the first activation element is triggered by proximity to the additional activation element at a distance of less than 5 mm, preferably less than 1 mm. Alternatively, the first activation element is triggered by contact with the additional activation element.

[0034] In one particular embodiment of the method, the second activation element comprises a state-change sensor that measures a change in state under the influence of pressure applied to the second activation element that causes movement of at least a portion of the second activation element.

[0035] The second activation element is preferably selected from the group consisting of a push button, a switch or an electric switch.

[0036] In another particular embodiment of the method, a second activation element is triggered to switch on the command system.

[0037] Preferably, the command system is configured to remotely activate commands for the medical device, and thus functions as a remote commander. Specifically, the command system includes at least one radio frequency transmitter that communicates wirelessly with the medical device, and the radio frequency transmitter of the command system is paired with a radio frequency receiver of the medical device prior to activation of the commands for the medical device by the command system.

[0038] According to another specific embodiment of the method, the activation of the command of the medical device by the command system is displayed by a display located on the command system.

[0039] Preferably, a medical device for occluding a natural duct in a human or animal body is ordered selected from the group consisting of an artificial sphincter, an artificial muscle, an electrical stimulator, a gastric ring, a neurostimulator or a penile implant.

[0040] Further features and advantages of the present invention will become apparent from the following detailed description, taken in conjunction with the accompanying drawings. [Brief explanation of the drawings]

[0041] [Figure 1] 1 shows a schematic diagram of a command system and a medical device implanted in a human or animal body according to one embodiment of the present invention. [Figure 2] 1 shows a diagram of the architecture of a command system according to the present invention; [Figure 3] 10A and 10B illustrate schematically the activation of commands for a medical device by a command system. DETAILED DESCRIPTION OF THE INVENTION

[0042] Figure 1 shows a schematic diagram of a system 1 for remotely commanding a medical device 2. The medical device 2 is shown implanted in a human or animal patient's body, which is represented in Figure 1 by reference numeral 3, which symbolizes the skin of the body. It should be noted that what is represented in Figure 1 to the right of the human or animal body skin 3 refers to what is implanted in the body, in this case, a medical device 2 that is implanted during, for example, a surgical procedure. Thus, to the left of the human or animal body skin 2 is what is not implanted in the body, in this case, the command system 1.

[0043] According to the present invention, the command system 1 comprises a first activation element 4 (activation element) and a second activation element 5 (activation element) for commanding the medical device 2. The first activation element 4 is configured to be triggered by proximity to an additional activation element 6, while the second activation element 5 is configured to be triggered by pressure applied to said second activation element. The two activation elements are therefore of a different nature, i.e. they are triggered by different techniques that do not interact with each other, which has the effect of significantly reducing unintentional activation of commands by the patient, as will be explained in more detail below.

[0044] In particular, the first activation element 4 comprises a proximity or contact sensor 7 selected from the group consisting of tactile, resistive, capacitive, inductive, infrared, optical, magnetic, or fingerprint recognition sensors. By "proximity" we mean that the sensor 7 detects the presence of the additional activation element 6 when the additional activation element 6 is less than 5 millimeters, preferably less than 1 millimeter, from the sensor 7.

[0045] This type of sensor 7 measures or detects the presence of the additional activation element 6 when the additional activation element 6 is in proximity to or in physical contact with the sensor, thereby triggering the first activation element. According to the invention, the additional activation element 6 is distinct from the command system 1, i.e. the additional activation element 6 is not part of the command system 1. Preferably, the additional activation element 6 consists of a part of a human or animal body, for example a finger 6, but the additional activation element 6 may also be in the form of a stylus or badge, in particular a magnetic or electromagnetic badge or chip.

[0046] In the case of the fingerprint recognition sensor 7, it is provided that the sensor is configured to recognize at least a first sequence of fingerprints that activates a first command, for example the opening of the urethra, and at least a second sequence of fingerprints different from the first command that activates a second command, for example a request for information about the pressure that the medical device exerts on the natural duct or the open or sealed state of the duct.

[0047] The second activation element 5 in turn includes a sensor 8 that measures a change in state. In particular, pressure applied to the second activation element 5 causes a movement of at least a portion of said second activation element, and thus a change in state of a portion of the second activation element, for example between a high position and a low position, as measured or detected by the sensor 8.

[0048] For example, this second activation element 5 is selected from the group consisting of a push button, a switch, or an electric switch. The push button is provided with a return spring that allows the push button to return to its initial position when pressure is no longer applied to the push button.

[0049] Preferably, the first and second activation elements are arranged in a recessed housing to avoid unintentional activation of a command triggered by an additional element passing in close proximity to the surface of the command system 1. Indeed, in this case, said additional element needs to enter the recess in order to activate the command, since simple contact with the surface is not sufficient.

[0050] In the embodiment shown in Figure 1, the first activation element 4 and the second activation element 5 are located at different positions on the command system 1. In the example shown in Figure 1, the shape of the command system 1 is substantially parallel, such that the first activation element 4 and the second activation element 5 are juxtaposed to each other and located on the same side of the command system 1.

[0051] Alternatively, the first activation element 4 and the second activation element 5 are arranged on opposite sides of the command system 1. Advantageously, this embodiment allows the user to activate commands of the implanted medical device 2 by contact of a finger, for example the index finger, with the first activation element 4 and by pressure of another finger, for example the thumb or middle finger, on the second activation element 5. This embodiment has particular ergonomics adapted to triggering the first and second activation elements with the fingers of one hand, since in this case the command device 1 is easily held securely between the thumb and the index or middle finger.

[0052] Further alternatively, although not shown, the first activation element 4 and the second activation element 5 are co-located on the command device 1 such that they overlap, so that only one activation element is visible to the user. This configuration has the advantage that both the first and second activation elements can be triggered, and thus a command of the medical device can be activated, by a single action of the patient.

[0053] The command system 1 further comprises a display 9 which indicates, for example by means of an optical signal, that activation of a command by the command system 1 has been considered and that the command, consisting of, for example, opening an anatomical duct, is executed by the medical device 2.

[0054] To this end, in a particular exemplary embodiment of the artificial urinary sphincter, it is provided that the medical device 2 comprises at least one inflatable occlusion cuff 10 surrounding the natural duct 11 (in this case the urethra) and a tubular fluid connection 12, one end of which is connected to the cuff 10 so as to form a fluid connection with the remainder of the medical device 2.

[0055] In particular, the medical device 2 also includes a control unit and a pump (not shown for clarity), which itself includes a variable volume reservoir. The pump reservoir is filled with fluid and is connected to the other end of the tubular fluid connection 12. The pump reservoir, the tubular fluid connection 12, and the occlusion cuff 10 thus form a single fluid circuit, whereby fluid can be transferred bidirectionally from the reservoir to the pump.

[0056] In operation, the unit controls the pump to increase or decrease the volume of fluid in the reservoir and hence the amount of fluid in the cuff 10 through the fluid circuit. This arrangement has the effect of allowing the cuff to be inflated or deflated to increase or decrease the compression applied, thus compressively sealing or releasing the urethra 11, thereby preventing urine leakage in incontinent patients.

[0057] Thus, the medical device 2, including the occlusion cuff 10, the tubular fluid connection 12, the command unit, the pump and the reservoir, is implanted inside the human or animal body (to the right of the skin 3 in Figure 1) so as to be remotely commanded by the command system 1 located outside the body (to the left of the skin 3 in Figure 1).

[0058] Furthermore, according to the present invention, it is envisaged that commands of the medical device 2 may consist in activating or deactivating the device, for example to implement a particular operating mode of the device, for example to know the state of the device, in particular the charge state of the device's energy source, to configure its internal parameters or even to request information from the device.

[0059] FIG. 2 shows the detailed architecture of the command system 1 and its general operation in relation to the medical device 2.

[0060] Specifically, the command system 1 includes a proximity sensor 7 associated with the first activation element 4, a state change sensor 8 associated with the second activation element 5, a control / command unit 13, and a transmitter / receiver 14 for radio frequency signals 16.

[0061] The control / command unit 13 is connected to the first activation element 4 and the second activation element 5, and to the transmitter / receiver 14. It can therefore receive a trigger signal from the first activation element 4 indicating that an additional activation element 6, for example a finger of a hand, has been detected in proximity to or in contact with the proximity sensor 7. Similarly, the control / command unit 13 can receive a trigger signal from the second activation element 5 indicating that pressure has been applied to the state change sensor 8.

[0062] Upon receiving the trigger signals from the first activation element 4 and the second activation element 5, the control / command unit 13 processes the trigger signals and determines a command activation signal for the medical device 2 to be sent to the transmitter / receiver 14.

[0063] Having received the command activation signal, transmitter / receiver 14 transmits a radio frequency signal 16 to transmitter / receiver 15 of medical device 2. This signal is then sent by transmitter / receiver 15 to a control unit (not shown) of medical device 2 to be processed in order to command the release of urethra 11 in the exemplary embodiment of the artificial urinary sphincter as described above.

[0064] Prior to activation of a command of the medical device 2 by the command system 1 and prior to radio frequency communication between the command system 1 and the medical device 2, pairing of the transmitter / receiver 14 of the command system with the transmitter / receiver 15 of the medical device 2 is preferably provided.

[0065] According to one particular embodiment of the pairing between the transmitter / receiver 14 and the transmitter / receiver 15, the command system 1, equipped with a barcode reader, reads a pairing code of the medical device 2, for example in the form of a barcode, placed on the packaging of the medical device. This pairing code constitutes a secret key that allows communication between the two transmitter / receivers.

[0066] This pairing step not only makes it possible to establish secure communication, but also makes it possible to ensure that the patient commands and communicates with the correct medical device. In fact, given the range of the radio frequency transmitter / receiver, which is typically a few meters, if several medical devices are in the vicinity of the command system without a pairing step, there is a risk of confusion resulting in communication with a medical device different from the one with which it is desired to communicate.

[0067] At the end of the pairing step, the command system 1 and the medical device 2 are configured to communicate securely with each other and the command system 1 can activate commands on the medical device 2.

[0068] Preferably, the frequency band for communication between the two transmitters / receivers 14 and 15 is a dedicated frequency band set aside for medical devices, different from frequency bands intended for consumer use, thus ensuring communication security between the command system and the implanted medical device and avoiding activation of commands that do not originate from the patient's command system 1.

[0069] An exemplary embodiment of a method for activating a command of a medical device will now be detailed in connection with FIG.

[0070] According to this particular exemplary embodiment, in which the command system is in an initial switched-off state, the patient triggers the second activation element 5, e.g., a push button, by applying pressure to the second activation element 5 with a finger in step 20, which has the inventive effect of switching on the command system 1 in step 21.

[0071] Advantageously, this switch-on step saves energy when the system is off.

[0072] Once the switch is turned on in a configuration in which the first activation element 4 and the second activation element 5 are co-located on the command device 1, a finger still positioned on the second activation element 5 triggers the first activation element 4 in step 22.

[0073] Preferably, consecutive triggering of the first activation element 4 and the second activation element 5 in a time interval of less than 100 milliseconds results in activation of the command of the medical device 2 in step 23 .

[0074] The command system 1 communicates with the medical device 2 as described above and activates commands that consist, for example, in applying a reduction in the pressure of the cuff 10 to the natural duct 11 .

[0075] It is provided that the acknowledgement of the command by the medical device 2 and its execution is displayed in the command system 1 by a display, for example comprising an optical display of the light-emitting diode LED type.

[0076] Following activation of the command in step 23, a timer for the command system 1 is started in step 24, which counts the time before the system 1 is turned off again.

[0077] Alternatively, the command system 1 is assumed to be permanently on, in which case simultaneous triggering of activation elements 4 and 5 results in activation of the command, in a configuration in which activation elements 4 and 5 are located in different locations on the system 1.

[0078] To save energy, the medical device can be automatically switched off outside the activation phase. Therefore, communication with the command system requires prior awakening (switching on) of the medical device. Such awakening can be achieved by continuous (loop) communication attempts by the command system after the command system is activated by triggering two activation elements. The awakening of the medical device may be indicated on the command system by the display described above, for example, by lighting an LED. To implement such an awakening function, the command system may include two antennas with different polarizations configured to switch on the medical device. These two polarizations improve communication between the command system and the medical device for different relative positions and / or orientations of the command system and the medical device. Unless communication is established between the command system and the medical device, the user operates the command system in different positions and / or orientations until the command system display indicates the awakening of the medical device. An advantage of this configuration of the command system is that awakening the medical device requires only one trigger of the command system's activation elements, thereby reducing pairing time.

[0079] It will be understood that the above-described embodiments are specific, non-limiting examples and that various modifications may be made without departing from the invention.

Claims

1. 1. A command system for remotely commanding a medical device configured to be implanted in a human or animal body, comprising: the command system is configured to establish communication with the medical device on a frequency band dedicated to the medical device, the command system including at least a first activation element and a second activation element for commanding the medical device, the first activation element configured to be triggered by proximity to an additional activation element, and the second activation element configured to be triggered by pressure applied to the second activation element, the first activation element and the second activation element being disposed within a recessed housing; the command system is configured to activate a command of the medical device after triggering the first activation element and the second activation element. Command system.

2. The command system of claim 1 , configured to activate a command of the medical device after simultaneous triggering of the first activation element and the second activation element.

3. The command system of claim 1 , configured to activate a command of the medical device after successive triggering of the first activation element and the second activation element.

4. A command system according to any one of claims 1 to 3, configured to activate a command of the medical device after successive triggering of the first activation element and the second activation element performed at a time interval of less than 1 second, preferably less than 500 milliseconds, and more preferably less than or equal to 100 milliseconds.

5. 5. The command system according to claim 1, wherein the first activation element and the second activation element are located at different locations on the command system, preferably on opposite sides of the command system.

6. The command system of claim 1 or 3, wherein the first activation element and the second activation element are co-located on the command system so as to overlap.

7. 7. The command system of claim 1, wherein the first activation element comprises a sensor selected from the group consisting of a tactile sensor, a resistive sensor, a capacitive sensor, an inductive sensor, an infrared sensor, an optical sensor, a magnetic sensor, or a fingerprint recognition sensor.

8. The command system of any one of claims 1 to 7, wherein the first activation element includes a fingerprint recognition sensor configured to recognize at least a first consecutive fingerprint that activates a first command of the medical device and at least a second consecutive fingerprint that activates a second command of the medical device, the first command being different from the second command.

9. 9. The command system of claim 1, wherein the first activation element is separate from the command system and is configured to be triggered by proximity to an additional activation element selected from a part of a human or animal body, preferably a finger, a stylus or a badge or a clip, in particular a magnetic or electromagnetic stylus or badge or clip.

10. 10. The command system of claim 1, wherein the first activation element is configured to be triggered by proximity to the additional activation element at a distance of less than 5 millimeters, preferably less than 1 millimeter.

11. A command system according to any one of claims 1 to 9, wherein the first activation element is configured to be triggered by contact with the further activation element.

12. 12. The command system of claim 1, wherein the second activation element includes a state-change sensor that measures a change in state under the effect of pressure applied to the second activation element that causes movement of at least a portion of the second activation element.

13. The command system according to any one of claims 1 to 12, wherein the second activation element is selected from the group consisting of a push button, a switch and an electric switch.

14. A command system according to any one of claims 1 to 13, wherein the trigger of the second activation element is configured to switch on the command system.

15. A command system according to any one of claims 1 to 14, configured to remotely activate commands of the medical device outside or without contact with a human or animal body.

16. The command system of any one of claims 1 to 15, comprising at least one radio frequency transmitter configured to communicate wirelessly with the medical device.

17. 17. The command system of claim 16, wherein the radio frequency transmitter of the command system is configured to be paired with the radio frequency receiver of the medical device prior to activation of a command of the medical device by the command system.

18. A command system according to any preceding claim, including a display indicating activation of a command of the medical device by the command system.

19. A command system according to any one of claims 1 to 18, configured to command a medical device to occlude a natural duct in a human or animal body.

20. 20. The command system of any one of claims 1 to 19, configured to be implanted in a human or animal body and configured to command a medical device selected from the group consisting of an artificial sphincter, an artificial muscle, an electrical stimulator, a gastric ring, a neurostimulator or a penile implant.

21. A medical apparatus comprising a command system according to any one of claims 1 to 20 and a medical device adapted to be implanted in the human or animal body.

22. 1. A method for remotely commanding a medical device configured to be implanted in a human or animal body by a command system, comprising: The command system is configured to establish communication with the medical device over a frequency band dedicated to the medical device, the command system including at least a first activation element and a second activation element for remotely commanding the medical device, the first activation element and the second activation element being disposed within a recessed housing, and the method includes at least: - the command system triggering the first activation element by proximity to an additional activation element and triggering the second activation element by pressure applied to the second activation element; the command system activating a command of the medical device after triggering of the first activation element and the second activation element, method.

23. 23. The method of claim 22, wherein the command system activates a command of the medical device after simultaneous triggering of the first activation element and the second activation element.

24. 23. The method of claim 22, wherein the command system activates a command of the medical device after successive triggering of the first activation element and the second activation element.

25. 25. The method according to any one of claims 22 to 24, wherein the additional activation element is provided separately from the command system and consists of a part of the human or animal body, preferably a finger, a stylus or badge or clip, in particular a magnetic or electromagnetic stylus or badge or clip.

26. 26. The method according to any one of claims 22 to 25, wherein the first activation element is triggered by proximity to the further activation element at a distance of less than 5 millimeters, preferably less than 1 millimeter.

27. The method of any one of claims 22 to 25, wherein the first activation element is triggered by contact with the further activation element.

28. 28. The method of any one of claims 22 to 27, wherein the second activation element comprises a state-change sensor that measures a change of state under the effect of pressure applied to the second activation element causing movement of at least a portion of the second activation element.

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