System and method for controlling a medical device configured for implantation

Abstract

The present invention relates to a method and system for remotely controlling (1) a medical device (2) arranged to be implanted in a human or animal body, the control system comprising at least: a first activation element (4) and a second activation element (5) for controlling the medical device, the first activation element being designed to be triggered by approaching an additional activation element (6), the second activation element being designed to be triggered by pressure applied to the second activation element, the control system being designed to activate control of the medical device when the first activation element and the second activation element are triggered.

Description

Technical Field

[0001] The invention relates to a system for controlling a medical device implantable in a human or animal body.

[0002] The present invention relates in particular to active implantable medical devices, ie medical devices whose operation relies on a source of electrical energy and which require an adapted control system. Background Art

[0003] There are many medical devices that can be implanted in a patient to perform a function within the patient, for example, to compensate for a malfunction of a natural organ.

[0004] In particular, implantable medical devices for selectively closing anatomical conduits are known, for example for the treatment of incontinence (in the case of artificial urinary and anal sphincters) or for limiting the passage of food into the stomach (in the case of gastric banding). Closure of anatomical conduits is usually caused by compression of a sleeve wrapped around the conduit.

[0005] Generally, an artificial urinary sphincter comprises a closure sleeve implanted around the urethra, possibly around the bladder neck in the case of a female implant, or around the prostate in the case of a male implant, to compress the urethra to prevent leakage of urine, particularly in the case of incontinence in the patient. A control system is also provided, which is arranged to activate control of the artificial sphincter, for example, to adjust the compression applied by the sleeve to close or open the natural conduit.

[0006] In older artificial sphincters, the medical device is arranged so that manual action by the patient (eg, applying pressure to a pump device placed under the skin) can activate control of the artificial sphincter.

[0007] Today, more complex systems are being developed to avoid the patient having to manually depress the pump to control the sleeve.

[0008] The artificial sphincter then comprises a remote control system not implanted in the patient, adapted to activate the control of the implanted medical device, for example by effecting a reduction in the pressure exerted by the sleeve on the natural conduit.

[0009] There are currently different types of implantable medical devices that can be remotely activated by a control system that is not implanted in the patient's body (such as an artificial urinary sphincter). These implantable medical devices, such as artificial urinary sphincters, implement different sleeve technologies (hydraulic, mechanical, inflatable, etc.) and different piezoelectric actuator technologies, cables, etc.

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

[0011] However, implantable medical devices that can be remotely activated by a control system that is not implanted in the patient have the disadvantage that the device can be mistakenly (i.e. unintentionally) activated by the patient. This is typically the case when the control system is manipulated accidentally, for example, when the control system is in the form of a remote control device with a button that triggers the activation of the control of the implantable medical device and the remote control device is placed in the patient's trouser pocket. In this case, a simple change in the patient's posture may lead to an unintentional pressure on the remote control button, resulting in the activation of the control of the medical device, for example, reducing the pressure in the sleeve and causing the patient to urinate unintentionally.

[0012] These conditions create very difficult situations for the patient.Therefore, there is a need for a system for remote control of an implantable medical device in which inadvertent control is avoided. Summary of the invention

[0013] The object of the present invention is therefore to remedy these drawbacks by providing a system for remote control of a medical device implanted in the human or animal body, the system activating the control only as a result of an intentional action of the patient.

[0014] To this end, the present invention provides a system for remotely controlling a medical device configured to be implanted in a human or animal body, the control system comprising at least: a first activation element and a second activation element for controlling the medical device, the first activation element being configured to be triggered by approaching an additional activation element, the second activation element being configured to be triggered by pressure applied to the second activation element, the control system being configured to activate control of the medical device when the first activation element and the second activation element are triggered.

[0015] The invention therefore relates to a control system not implanted in a patient, which is capable of remotely controlling a medical device implanted in a human or animal body. By implantation it is understood that this relates to a medical device introduced into a human or animal body, for example during surgery.

[0016] Advantageously, it will be noted that activating the control of the implanted medical device by triggering two activation elements of different nature makes it possible to significantly reduce the activation of unintentional controls by the patient.

[0017] According to one embodiment of the invention, the control system is arranged to activate the control of the medical device when the first activation element and the second activation element are triggered simultaneously, while according to another embodiment, the control system is arranged to activate the control of the medical device when the first activation element and the second activation element are triggered consecutively. Preferably, the consecutive triggering of the first activation element and the second activation element is performed within a time interval of less than 1 second, preferably less than 500 milliseconds, more preferably less than or equal to 100 milliseconds.

[0018] According to a specific embodiment of the invention, the first activation element and the second activation element are arranged at different positions of the control system, preferably at opposite sides of the control system, while according to another embodiment, the first activation element and the second activation element are arranged at the same position of the control system 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, the fingerprint recognition sensor is configured to recognize at least a first fingerprint series to activate a first control of the medical device, and recognize at least a second fingerprint series to activate a second control of the medical device, the first control being different from the second control.

[0020] According to one embodiment of the invention, the additional activation element is separate from the control system and comprises: a part of the human or animal body, preferably a finger; a stylus; or a badge or a chip, in particular of a magnetic or electromagnetic nature.

[0021] According to another embodiment of the invention, the first activation element is arranged to be triggered by approaching the additional activation element at a distance of less than 5 mm, preferably less than 1 mm. Alternatively, the first activation element is arranged to be triggered by making contact with the additional activation element.

[0022] In a particular embodiment of the invention, the second activation element comprises a state change sensor, which measures a state change under the effect of a pressure applied to the second activation element, which pressure causes a movement of at least a part of the second activation element. The second activation element is preferably selected from the group consisting of a button, a switch or an electric switch.

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

[0024] Preferably, the control system is configured to remotely activate control of the medical device. That is, the control system is located outside the human or animal body and is not in contact with the human or animal body. It is therefore understood that the control system is not implanted and is not implanted in the human or animal body. It is therefore provided that the control system comprises at least one radio frequency transmitter, the radio frequency transmitter being configured to wirelessly communicate with the medical device, the radio frequency transmitter being configured to pair with a radio frequency receiver of the medical device before control of the medical device is activated by the control system.

[0025] According to a particular embodiment of the invention, the control system comprises display means indicating activation of the control of the medical device by the control system.

[0026] Preferably, the control system is configured to control 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 to seal a natural conduit in a human or animal body.

[0027] The invention extends to an item of medical equipment comprising a control system as described above and a medical device arranged to be implanted in a human or animal body.

[0028] The present invention further extends to a method for remotely controlling a medical device arranged to be implanted in a human or animal body, the method comprising at least the following steps:

[0029] - providing a control system comprising at least a first activation element for remotely controlling the medical device and a second activation element, the first activation element being triggered by approaching an additional activation element and the second activation element being triggered by pressure exerted on the second activation element,

[0030] Upon triggering of the first activation element and the second activation element of the control system, the control of the medical device is activated.

[0031] In one embodiment of the method according to the invention, the control system activates the control of the medical device when the first activation element and the second activation element are triggered simultaneously, while according to another embodiment, the control system activates the control of the medical device when the first activation element and the second activation element are triggered consecutively. Preferably, the consecutive triggering of the first activation element and the second activation element is performed within a time interval of less than 1 second, preferably less than 500 milliseconds, more preferably less than or equal to 100 milliseconds.

[0032] According to a particular embodiment of the method, the first and second activation elements are arranged at different locations of the control system, preferably on opposite sides of the control system, while according to another embodiment, the first and second activation elements are arranged at the same location of the control system.

[0033] According to another embodiment of the method, the first activation element is equipped with 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 fingerprint series to activate a first control of the medical device and recognizes at least a second fingerprint series to activate a second control of the medical device, the first control being different from the second control.

[0034] According to yet another embodiment of the method, the additional activation element is separate from the control system and comprises: a part of the human or animal body, preferably a finger; or a stylus; or a marker or a chip, in particular of a magnetic or electromagnetic nature.

[0035] According to an embodiment of the method, the first activation element is triggered by approaching the attached activation element at a distance of less than 5 mm, preferably less than 1 mm. Alternatively, the first activation element is triggered by coming into contact with the attached activation element.

[0036] In a particular embodiment of the method, the second activation element is equipped with a state change sensor which measures a state change under the effect of a pressure exerted on the second activation element, which pressure causes a movement of at least a portion of the second activation element.

[0037] The second activation element is preferably selected from the group consisting of a button, a switch or an electric switch.

[0038] In another particular embodiment of the method, a second activation element is triggered to cause the control system to start.

[0039] Preferably, the control system is configured to remotely activate control of the medical device. Thus, the control system acts as a remote control device. In particular, the control system is equipped with at least one radio frequency transmitter for wireless communication with the medical device, and the radio frequency transmitter of the control system is paired with the radio frequency receiver of the medical device before the control of the medical device is activated by the control system.

[0040] According to another particular embodiment of the method, the activation of the control of the medical device by the control system is displayed by a display device provided on the control system.

[0041] Preferably, a medical device for closing a natural conduit in a human or animal body is controlled, the medical device being selected from the group consisting of an artificial sphincter, an artificial muscle, an electrical stimulator, a gastric ring, a neurostimulator or a penile implant. BRIEF DESCRIPTION OF THE DRAWINGS

[0042] Further features and advantages of the present invention will become apparent from the following detailed description with reference to the accompanying drawings, in which:

[0043] - Figure 1 A schematic diagram showing a control system and a medical device implanted in a human or animal body according to an embodiment of the present invention;

[0044] - Figure 2 A schematic diagram showing the architecture of a control system according to the present invention;

[0045] - Figure 3 Activation of control of a medical device by a control system is schematically illustrated. DETAILED DESCRIPTION

[0046] Figure 1 A system 1 for remotely controlling a medical device 2 is schematically shown. The medical device 2 is shown implanted in a human or animal body of a patient, the patient being Figure 1 The reference numeral 3 in the figure symbolizing the body skin partially indicates. Figure 1 In the figure, it is noted that what is represented on the right side of the skin 3 of the human or animal body refers to an implanted device, in this example a medical device 2 (e.g. a medical device implanted during surgery). Thus, on the left side of the skin 2 of the human or animal body is a non-implanted device, in this example a control system 1.

[0047] According to the invention, the control system 1 comprises a first activation element 4 and a second activation element 5 for controlling a medical device 2. The first activation element 4 is arranged to be triggered by approaching an additional activation element 6, while the second activation element 5 is arranged to be triggered by pressure exerted on the second activation element. Therefore, the two activation elements have different properties, i.e. the two activation elements are triggered by different techniques that do not interact with each other, and this can significantly reduce the activation of unintentional control of the patient, as described in detail below.

[0048] In particular, the first activation element 4 comprises a proximity or contact sensor 7 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. The so-called "proximity" means that the sensor 7 detects the presence of the additional activation element 6 when the distance between the additional activation element 6 and the sensor 7 is less than 5 mm, preferably less than 1 mm.

[0049] This type of sensor 7 measures or detects the presence of the additional activation element 6 when the additional activation element 6 is close to the sensor or in physical contact with the sensor, thereby triggering the first activation element. According to the invention, the additional activation element 6 is separate from the control system 1, i.e. the additional activation element is not part of the control system. Preferably, the additional activation element comprises a part of the human or animal body, such as a finger 6, but the additional activation element may also be in the form of a stylus or a marker, in particular a magnetic or electromagnetic marker or chip.

[0050] In the case of a fingerprint recognition sensor 7, the sensor is configured to recognize at least a first fingerprint series to activate a first control, such as opening the urethra, and to recognize at least a second fingerprint series different from the first fingerprint series to activate a second control, such as requesting information about the pressure exerted by the medical device on the natural catheter or on the catheter in an open or closed state.

[0051] The second activation element 5 in turn comprises a sensor 8 for measuring a change of state. In particular, pressure exerted on the second activation element 5 causes a movement of at least a portion of the second activation element and thereby causes the sensor 8 to measure or detect a change of state, such as a change of state between a high position and a low position of a portion of the second activation element.

[0052] For example, the second activation element 5 is selected from the group consisting of a button, a switch or an electric switch. The button is equipped with a return spring which allows the button to return to its initial position when no pressure is applied to the button.

[0053] Preferably, the first and second activation elements are arranged in recessed housings to avoid activation of unintentional controls that would be triggered by an additional element approaching the surface of the control system 1. In fact, in this case, in order to activate the control, said additional element must enter the recess, since simple contact with the surface is not sufficient to activate the control.

[0054] exist Figure 1 In the illustrated embodiment, the first activation element 4 and the second activation element 5 are arranged at different positions of the control system. Figure 1 In the example shown, the control system 1 is substantially in the shape of a parallelepiped, so that the first activating element 4 and the second activating element 5 are arranged next to each other on the same side of the control system 1 .

[0055] Alternatively, the first activation element 4 and the second activation element 5 are arranged on opposite sides of the control system 1. Advantageously, this embodiment enables the user to activate the control of the implantable medical device 2 by contact of a finger (e.g. the index finger) with the first activation element 4 and by pressure of another finger (e.g. the thumb or the middle finger) on the second activation element 5. This embodiment has a particular ergonomics suitable for triggering the first and second activation elements by the fingers of one hand, since in this case the control device 1 is easily and securely held between the thumb and the index or middle finger.

[0056] Still alternatively, but not shown, the first activation element 4 and the second activation element 5 are arranged at the same position on the control device 1, so that the first activation element and the second activation element overlap, so that only one activation element is visible to the user. The advantage of this configuration is that the first activation element and the second activation element can be triggered, thereby activating the control of the medical device by a single action of the patient.

[0057] The control system 1 further comprises display means 9 which indicate (eg by light signals) that activation of the control by the control system 1 has been taken into account and that the medical device 2 will perform a control comprising opening an anatomical duct, for example.

[0058] To this end, and in a specific exemplary embodiment of an artificial urinary sphincter, it is provided that the medical device 2 comprises at least one inflatable sealing sleeve 10 surrounding a natural conduit 11 (in this case the urethra) and a tubular fluid connector 12, one end of which is connected to the sleeve 10 to establish a fluid connection with the rest of the medical device 2.

[0059] In particular, the medical device 2 further comprises a control unit and a pump (not shown for clarity), the pump itself comprising a variable volume reservoir. The pump reservoir is filled with fluid and connected to the other end of the tubular fluid connection 12. Thus, the pump reservoir, the tubular fluid connection 12 and the closed sleeve 10 form a single fluid circuit, in which the fluid can be bidirectionally delivered from the reservoir to the pump.

[0060] In operation, the unit controls the pump to increase or decrease the volume of fluid in the reservoir and thereby, through the fluid circuit, increase or decrease the amount of fluid in the sleeve 10. This arrangement has the effect of enabling the sleeve to be inflated or deflated to increase or decrease the applied compression and thereby compressively close or release the urethra 11, thereby preventing leakage of urine from an incontinent patient.

[0061] Thus, the medical device 2 comprising the closure sleeve 10, the tubular fluid connection 12, the control unit, the pump and the reservoir is implanted in a human or animal body ( Figure 1 on the right side of the skin 3) so that the Figure 1 The control system 1 on the left side of the skin 3 is remotely controlled.

[0062] Furthermore, it is conceivable according to the present invention that control of the medical device 2 may include activation or deactivation of the device, for example, in order to achieve a specific operating mode of the device, configure its internal parameters, or even request information from the device, for example, in order to understand the status of the device, in particular the charge state of the device's energy source.

[0063] Figure 2 The detailed architecture of the control system 1 and the overall operation of the control system in relation to the medical device 2 are shown.

[0064] In particular, the control system 1 comprises 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 / control unit 13 and a transmitter / receiver 14 of radio frequency signals 16 .

[0065] The control / control unit 13 is connected to the first activation element 4 and the second activation element 5 and the transmitter / receiver 14. Thus, the control / command unit is able to receive a trigger signal from the first activation element 4 indicating that an additional activation element 6 (e.g. a finger of a hand) is detected approaching or contacting the proximity sensor 7. Similarly, the control / control unit 13 is able to receive a trigger signal from the second activation element 5 indicating that pressure has been applied to the state change sensor 8.

[0066] Upon receiving the trigger signals from the first activation element 4 and the second activation element 5 , the control / control unit 13 processes the trigger signals and determines a control activation signal for the medical device 2 , which is sent to the transmitter / receiver 14 .

[0067] The transmitter / receiver 14 receiving the control activation signal sends a radio frequency signal 16 to the transmitter / receiver 15 of the medical device 2. The radio frequency signal is then sent by the transmitter / receiver 15 to a control unit (not shown) of the medical device 2 for processing and is used to control the opening of the urethra 11 in the exemplary embodiment of the artificial urinary sphincter as described above.

[0068] Before the control system 1 activates control of the medical device 2 and before radio frequency communication is performed between the control system 1 and the medical device 2 , the transmitter / receiver 14 of the control system is preferably paired with the transmitter / receiver 15 of the medical device 2 .

[0069] According to a particular embodiment of the pairing between the transmitter / receivers 14 and 15, the control system 1 equipped with a barcode reader reads the pairing code of the medical device 2, which is provided, for example, in the form of a barcode on the packaging of the medical device. This pairing code constitutes a key for authorizing the communication between the two transmitter / receivers.

[0070] This pairing step enables secure communication to be established while also ensuring that the patient controls and communicates with the correct medical device. Indeed, given that the range of radio frequency transmitters / receivers is typically several meters, if multiple medical devices are close to the control system, without a pairing step, there is a risk of confusion resulting in communication with a medical device other than the intended one.

[0071] At the end of the pairing step, the control system 1 and the medical device 2 are configured to communicate together securely and the control system 1 can activate control of the medical device 2 .

[0072] Preferably, the frequency band used for communication between the two transmitter / receivers 14 and 15 is a dedicated frequency band reserved for medical devices, which is different from the frequency band used for consumer applications, thereby ensuring the security of communication between the control system and the implanted medical device and avoiding the activation of controls of the control system 1 that do not come from the patient.

[0073] Combination Figure 3 , an exemplary embodiment of a method for activating control of a medical device will now be described in detail.

[0074] According to this particular exemplary embodiment, in this embodiment, the control system is in an initially closed state, and the patient triggers the second activation element by applying pressure with a finger on the second activation element 5 (e.g., a button) in step 20, and this step of applying pressure according to the present invention has the effect of turning on the control system 1 in step 21.

[0075] Advantageously, this activation step saves energy when the system is shut down.

[0076] Once switched on and in a configuration in which the first activating element 4 and the second activating element 5 are arranged at the same position on the control device 1 , in step 22 the finger still positioned on the second activating element 5 triggers the first activating element 4 .

[0077] The successive triggering of the first activation element 4 and the second activation element 5 , preferably within a time interval of less than 100 milliseconds, leads to the activation of the control of the medical device 2 in step 23 .

[0078] The control system 1 communicates with the medical device 2 as described above and activates control, which includes, for example, reducing the pressure exerted by the sleeve 10 on the native conduit 11.

[0079] It is provided that the confirmation and execution of the control by the medical device 2 is indicated on the control system 1 by means of a display device having a light display (for example of the light emitting diode LED type).

[0080] After activation of the control in step 23 , a timer of the control system 1 is started in step 24 , which timer counts down before the system 1 is switched off again.

[0081] Alternatively, it is envisaged that the control system 1 is permanently switched on. In this case, and in a configuration where the activation elements 4 and 5 are arranged at different locations on the system 1, a simultaneous triggering of the activation elements 4 and 5 will then result in activation of the control.

[0082] In order to save energy, the medical device can be automatically turned off outside the activation phase. Therefore, communication with the control system requires pre-awakening (turning on) the medical device. Such awakening can be achieved by continuous (cyclic) communication attempts performed by the control system after the control system is activated by triggering two activation elements. The awakening of the medical device can be indicated on the control system by the above-mentioned display device, for example, by the lighting of an LED. In order to achieve this wake-up function, the control system may include two antennas with different polarizations suitable for turning on the medical device. Due to these two polarizations, the communication between the control system and the medical device is improved for different relative positions and / or directions of the control system and the medical device. As long as communication is not established between the control system and the medical device, the user manipulates the control system in different positions and / or directions until the display device of the control system indicates that the medical device has been awakened. An advantage of this configuration of the control system is that waking up the medical device only requires the activation element of the control system to be triggered once, and thus reduces the pairing time.

[0083] It is to be understood that the above-described embodiments are specific and non-limiting examples and that various modifications may be made without departing from the present invention.

Claims

1. A control system (1) for remotely controlling a medical device (2) arranged to be implanted in a human or animal body, the control system comprising at least: A first activation element (4) and a second activation element (5) for controlling the medical device, wherein the first activation element is configured to be triggered by approaching an additional activation element (6), and the second activation element is configured to be triggered by pressure applied to the second activation element, the control system is configured to establish communication with the medical device in a frequency band reserved for the medical device, and is configured to activate control of the medical device when the triggering of the first activation element and the second activation element is performed simultaneously or when the triggering of the first activation element and the second activation element is performed continuously within a time interval of less than 1 second.

2. The control system according to claim 1, wherein: The first activation element (4) and the second activation element (5) are arranged at different positions of the control system (1).

3. The control system according to claim 1 or 2, wherein: The first activation element (4) and the second activation element (5) are arranged at the same position of the control system (1) so as to overlap.

4. The control system according to claim 1 or 2, wherein: The first activation element (4) comprises a sensor (7) 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.

5. The control system according to claim 1 or 2, wherein: The first activation element comprises a fingerprint recognition sensor (7) configured to recognize at least a first fingerprint series to activate a first control of the medical device, and to recognize at least a second fingerprint series to activate a second control of the medical device, the first control being different from the second control.

6. The control system according to claim 1 or 2, wherein: The first activation element is arranged to be triggered by approaching an additional activation element (6), which is separate from the control system (1) and is selected from: a part of a human or animal body; a stylus; or a marker or a chip.

7. The control system according to claim 1 or 2, wherein: The first activation element (4) is arranged to be triggered by approaching the additional activation element (6) at a distance of less than 5 mm.

8. The control system according to claim 1 or 2, wherein: The first activation element (4) is arranged to be triggered by coming into contact with the additional activation element (6).

9. The control system according to claim 1 or 2, wherein: The second activation element (5) comprises a state change sensor (8) which measures a state change under the effect of a pressure applied to the second activation element (5), the pressure causing a movement of at least a part of the second activation element.

10. The control system according to claim 1 or 2, wherein: The second activation element (5) is selected from the group consisting of a button, a switch and an electric switch.

11. The control system according to claim 1 or 2, wherein: The triggering of the second activation element (5) is configured to start the control system (1).

12. The control system according to claim 1 or 2, wherein: The control system (1) is configured to remotely activate control of the medical device outside of and without contact with the human or animal body.

13. The control system according to claim 1 or 2, wherein: The control system (1) comprises at least one radio frequency transmitter (14), which is configured to wirelessly communicate with the medical device.

14. The control system according to claim 13, wherein: The radio frequency transmitter (14) of the control system is configured to pair with a radio frequency receiver (15) of the medical device (2) before control of the medical device is activated by the control system.

15. The control system according to claim 1 or 2, wherein: The control system comprises a display device (9) which indicates activation of control of the medical device (2) by the control system (1).

16. The control system according to claim 1 or 2, wherein: The control system (1) is configured to control a medical device (2) to seal a natural conduit (11) in a human or animal body.

17. The control system according to claim 1 or 2, wherein: The control system (1) is configured to control a medical device, which is arranged to be implanted in a human or animal body and is selected from the group consisting of an artificial sphincter, an artificial muscle, an electrical stimulator, a gastric ring, a neurostimulator or a penile implant.

18. The control system according to claim 1, wherein: The control system is configured to activate control of the medical device when the triggering of the first activation element and the second activation element is performed consecutively within a time interval of less than 500 milliseconds.

19. The control system according to claim 18, wherein: The control system is configured to activate control of the medical device when the triggering of the first activation element and the second activation element is performed consecutively within a time interval less than or equal to 100 milliseconds.

20. The control system according to claim 2, wherein: The first activation element (4) and the second activation element (5) are arranged on opposite sides of the control system (1).

21. The control system according to claim 6, wherein: The part of the human or animal body is a finger.

22. The control system according to claim 6, wherein: The tag or chip is magnetic or electromagnetic.

23. The control system according to claim 7, wherein: The first activation element (4) is arranged to be triggered by approaching the additional activation element (6) at a distance of less than 1 mm.

24. An item of medical equipment comprising a control system (1) according to any one of the preceding claims and a medical device (2) arranged to be implanted in a human or animal body.

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