Methods for controlling an active medical implant

Abstract

The invention relates to a method for controlling an active medical implant (1) by means of a hearing instrument (20), wherein the active medical implant (1) checks a condition (B) for activating and / or changing a medical function (F), and upon occurrence of the condition (B), a corresponding first message (N1) is transmitted to the hearing instrument (20), wherein, based on the first message (N1), an electro-acoustic output transducer (28) of the hearing instrument (20) issues a user request (An) regarding the activation and / or change of the medical function (F) to a user of the active medical implant (1), wherein, based on a response of the user to the user request (An), a corresponding second message (N2) is transmitted from the hearing instrument (20) to the active medical implant (1).and wherein the activation and / or modification of the medical function (F) of the active medical implant (1) is carried out based on the second message (N2) about the user's response to the user request (To).

Description

The invention relates to a method for controlling an active medical implant, wherein a condition for an activation and / or change of a medical function is checked by the active medical implant.Active medical implants can stimulate, control, influence or even adopt relevant or complete functions of the human body in various medical relevant functions. Such implants may be provided, for example, by an insulin pump or an implanted medicament pump, or electrical stimulation devices for reducing chronic pain or shake. Since such implants are inserted in the body under the skin or control units of partial implants can be located at places under clothing that are less accessible in the daily practice, the reliable control of an implant can sometimes represent a technical problem. While, for example, the delivery of insulin can also be automatically controlled by an insulin pump by means of a corresponding measurement unit for the blood sugar level, it is sometimes nevertheless desirable to be able to influence such functions actively by the user (for example by delivering only a small amount of insulin if the user has only taken a small intermediate meal or the like).For this purpose, an active medical implant can also be designed to be controllable from the outside, for example by pressing or knocking on the site of the skin (for example as a knocking pattern) at which the implant is inserted. However, such an activation is only possible in a very roughly rastered manner due to the mechanical damping by the skin. For safety reasons, operating errors or an erroneous recognition of the control commands intended by the user must also be ruled out as reliably as possible, since this may otherwise be associated with a (possibly severe) health risk for the user, but therefore at least with partially considerable inconveniences. While it would theoretically be possible to activate an active medical implant via a smartphone, this type of external activation may not always be desirable, however, for social, practical or age-related reasons.The invention is therefore based on the object of allowing for an active medical implant to be controlled as reliably as possible and nevertheless user-friendly as to a medical function of the implant.The object mentioned is achieved according to the invention by a method for controlling an active medical implant by a hearing instrument, wherein a condition for an activation and / or change of a medical function is checked by the active medical implant, and a corresponding first message is transmitted to the hearing instrument upon entry of the condition, wherein a user request regarding the activation and / or change of the medical function is issued to a user of the active medical implant by means of the first message by means of an electro-acoustic output transducer of the hearing instrument, wherein a corresponding second message is transmitted from the hearing instrument to the active medical implant by means of a reaction of the user to the user request, and wherein the activation and / or change of the medical function of the active medical implant is carried out by means of the second message about the reaction of the user to the user request. Advantageous and partly per se inventive embodiments are the subject matter of the dependent claims and of the following description.In this case, a hearing instrument generally comprises any device which is configured to generate a sound signal from an electrical signal-which may also be provided by an internal signal of the device-and to supply it to an ear of a user of this device, that is to say in particular a headphone (e.g. as "earbud"), a headset, smart glasses with loudspeakers, etc. However, a hearing instrument in the narrower sense is also included as a hearing instrument, that is to say a device for supplying a hearing weakness of the user, in which an input signal generated from an environmental signal by means of a microphone is processed to form an output signal and in this case is amplified in particular as a function of the frequency band, and an output sound signal generated from the output signal by means of a loudspeaker or the like is suitable for at least partially compensating the hearing weakness of the user, in particular in a user-specific manner.The electro-acoustic output transducer comprises any device which is provided and configured to convert an electrical signal into a corresponding sound signal, wherein voltage and / or current fluctuations in the electrical signal are converted into corresponding amplitude fluctuations of the sound signal, that is to say in particular a loudspeaker, a so-called balanced metal case receiver, but also a bone guide listener.An active medical implant (hereinafter also only "implant") comprises in particular a device which is permanently (optionally interchangeably) inserted in the human body of a user at a location at least partially below the skin surface and which is provided and configured to stimulate, activate and / or influence a body function via a chemical and / or physical interaction with the body, in particular with the surrounding body tissue (the pressure exerted by the implant on the surrounding tissue as a result of its mere presence should not be considered as a physical interaction).Under an active medical implant, one of the following devices is in particular comprised: an insulin pump, an implanted medicament pump, an artificial sphincter (in particular urinary sphincter), a device for controlling a blood flow in a threshold body, a device for electrically stimulating tissue, a device for directly and / or indirectly controlling an organ movement (in particular at least one organ of the digestive tract), a device for stimulating and / or inhibiting a production of a gland secretion, a device for suppressing shakes and / or pain by nerve stimulation. In the case of a device for electrically stimulating tissue, the tissue can be given in particular by spinal cord tissue, spinal canal tissue, epidural space tissue, nerve and / or brain tissue, a ganglion (in particular ganglion pterygopalatinum), tissue in the vicinity of the spinal cord and / or the peripheral nerves of the spinal cord, an occipital nerve, a tibial nerve, a sacral and / or pudendus nerve, a ventral root of a spinal nerve, a movement nerve, muscle tissue.In particular, the active medical implant and the hearing instrument are two structurally separate devices which do not have a direct coordination with one another and are preferably distributed separately from one another. The communication between the implant and the hearing instrument is preferably effected by means of standardized transmission protocols.The checked condition is preferably matched to the medical function of the active medical implant to be controlled, and is preferably in direct physiological relationship with the associated body function which is to be stimulated, activated and / or influenced by the active medical implant.The condition for the activation and / or change of the medical function can preferably be checked in one of the following ways: Determined on the basis of a determined manual interaction by the user, in particular by applying pressure and / or knocking signals to a skin site over the implant for operating a sensing mechanism of the implant, by measuring a physiological parameter such as a blood sugar level (for example in the case of an insulin pump) or a pain level (in the case of a stimulator against chronic pain), but also a heart rate, a variation of the heart rate, a breathing rate and / or a brain current pattern which indicate a current underbasing, by detecting a physical reaction of the user such as, for example, dithering or drowsiness, by ascertaining a sporting activity of the user or another activity in his daily course, e.g. eating, by ascertaining a location position of the user and preferably a corresponding comparison of stored location information (thus, e.g. a stay of the user in his bathroom can be recognized), by ascertaining a time and preferably a comparison with a stored task or the like of the user.In particular, for checking the condition, a physiological parameter (e.g. as mentioned above) can be measured by the hearing instrument and / or a further external device worn on the body of the user, and the said physiological parameter (and / or a physiological information derived from the latter) can be transmitted from the hearing instrument or from the external device to the active medical implant. The condition for the activation and / or change of the medical function is then also checked in the implant on the basis of said physiological parameter (which is measured by the hearing instrument or by the external device) respectively.A medical function of the active medical implant is to be understood in particular as a physical and / or chemical interaction with the body of the user, which is provided and suitable for stimulating, activating and / or influencing a body function. In particular, a medical function includes a delivery of insulin or a medicament in the case of an insulin or medicament pump and an output of an electrical signal for stimulating tissue (or for stimulating the delivery of a gland secretion) in the case of a corresponding device. Preferably, the medical function of the active medical implant is not an immediately life-requiring or life-sustaining measure, as would be the case with a pacemaker or a defibrillator.Activation of the medical function is to be understood in particular as the onset of the chemical and / or physical interaction of the implant with the body after a period of time without the interaction. A change in the medical function includes, in particular, a change in an operating parameter of the implant, i.e., for example, the change in an (existing) electrical voltage in the case of an electrical stimulation of tissue, or in a delivery quantity (per unit time) of insulin or of a medicament in the case of a corresponding pump. However, changing the medical function also includes suspending the function.The active medical implant thus checks the condition for the activation and / or change of the medical function in the described manner, and transmits the first message, which is the subject matter of the proposed or imminent activation or change and in particular the content thereof, to the hearing instrument when the condition is fulfilled. On the basis of the first message, a user request is now issued to the user by the hearing instrument. This can comprise, in particular, a text-based (automatically read-forward) message which is played to the user.A reaction, and in particular also an absence of such a reaction, of the user to the user request is subsequently detected by the hearing instrument. The reaction can be carried out by manual input via a corresponding button on the hearing instrument, or else in a voice command verbalized by the user, which is detected via a microphone of the hearing instrument (and analyzed therein, for example, by means of voice recognition).On the basis of the reaction, the intention of the user with regard to the imminent or proposed activation and / or change of the medical function can now be recognized, that is to say in particular an approval / confirmation or a rejection / discard. Accordingly, the hearing instrument automatically generates a second message, which has said intention of the user for activation and / or change to the object and preferably to the content, and is transmitted to the implant. On the basis of the second message, the implant can thus record the user's approval or rejection for the proposed or imminent activation and / or change of the medical function, and in the corresponding case can carry out the activation and / or change in the sense of the user.This can ensure that, on the one hand, the control of the medical function takes into account the intention of the user and thus cannot take place against his explicit will, which would be possible, for example, in the case of fully automatic activation. On the other hand, the activation does not rely solely on gestures such as knocking signals or also tactile pressure by the user on the implant, which could possibly be recognized incorrectly.Expediently, the first message contains information about the medical function of the implant to be activated and / or changed. An explicit indication is thus given with the content that the or a specific medical function of the implant is to be activated or changed, preferably also specifying the extent of the change, as is proposed on the basis of the checked condition. In particular, the first message additionally includes a time period for a response to the user request. Thus, even in the absence of a response, a decision can be made with regard to the activation and / or change of the medical function of the implant. In addition, the operation can be simplified because there is a possibility for the user to omit a response in one case.It proves to be advantageous if information about an activation and / or change of the medical function proposed by the active medical implant is output in the user request, and the proposed activation and / or change only occurs when the user request is confirmed. This means in particular that the proposed activation or change is omitted if the user does not confirm it in response to the user request. In particular, this can also be the case if the user has elapsed a predefined time period unused for the response (which is preferably also communicated to him with the user request).In an alternative, likewise advantageous embodiment, information about an activation and / or change of the medical function imminent in the active medical implant is output in the user request, wherein the activation and / or change only occurs if no veto occurs in response to the user request. This means in particular that the proposed activation or change takes place if the user does not block it by his Veto in response to the user request. In particular, this can also be the case if the user has passed a predefined time period for the response (which is preferably also communicated to him with the user request) without his or her veto.Whether a non-state of the user blocks the activation or change of the medical function of the implant in response to the user request (since a required active confirmation fails) or permits it (since no veto has been inserted), is preferably selected in coordination with the corresponding function and the resulting simplicity of operation. For example, in the case of an implant which can determine a given activation and / or change of the intended medical function even with sufficient certainty via the corresponding condition, an active discard by a veto is optionally preferable to an active confirmation.It therefore proves to be further advantageous if the second message is generated after confirming the proposed activation and / or change of the medical function or after a failure to imminent activation and / or change of the medical function, on the one hand, or after a time delay has elapsed for a response to the user request, on the other hand, and contains information corresponding thereto in each case.Preferably, the first message and / or the second message are transmitted between the active medical implant and the hearing instrument by means of one of the following transmission paths: electromagnetic waves at radio frequency (RF) and / or in the infrared (IR) range and / or in the microwave (MW) range, magnetic induction, ultrasound. In this case, the type of transmission is particularly preferably matched to the implant, and optionally to further active medical implants of the user, in order to prevent interference during the transmission, and optionally to a pacemaker or defibrillator, in order not to interfere with its function by the transmission between the hearing instrument and the implant.The invention further provides a hearing instrument comprising an electroacoustic output transducer for outputting a user request to a user, means for inputting a response to said user request, communication means for receiving a message from an active medical implant and for transmitting a message to said active medical implant, and a control unit. The hearing device is configured to receive a first message from an active medical implant with regard to an activation and / or change of a medical function thereof, to output a corresponding user request to the user on the basis of the first message via the output converter, and to send a corresponding second message to the active medical implant on the basis of a reaction of the user to said user request detected via said means for input.The hearing instrument according to the invention shares the advantages of the method according to the invention. The advantages specified for the method and for its developments can be transferred analogously to the hearing instrument insofar as they relate to the latter.The invention also specifies an active medical implant, comprising means for checking a condition for an activation and / or change of a medical function, communication means for transmitting a first message about said activation and / or change to a hearing instrument, and for receiving a second message regarding a reaction of a user of the hearing instrument to a user request issued regarding the activation and / or change, and means for activating and / or changing the medical function depending on the received second message.The active medical implant of the invention shares the advantages of the method of the invention. The advantages specified for the method and for its developments can be transferred analogously to the active medical implant, insofar as they relate to the latter.An exemplary embodiment of the invention is explained in more detail below with reference to drawings. Here, in each case, diagrammatically show: FIG. 1 is a block diagram of an active medical implant that can be activated by means of a hearing instrument; and FIG. 2 is a block diagram of a method for controlling the active medical implant according to FIG. 1 by means of the hearing instrument.Mutually corresponding parts and sizes are each provided with the same reference numerals in all figures.FIG. 1 shows schematically in a block diagram an active medical implant 1 (also: "implant"). The implant 1 is provided in the present case by an insulin pump 2, but could also be provided by another of the devices mentioned above (among others: medicament pump, artificial sphincter, device for electrically stimulating tissue, device for directly and / or indirectly controlling organ movement, device for suppressing shake and / or pain by nerve stimulation). The implant 1 has means 4 for checking a condition for an activation and / or change of a medical function. Said medical function is in the present case provided by a dispensing of insulin from a reservoir 5 provided and configured accordingly thereto. In other embodiments, the means 4 are to be adapted accordingly to the medical function. In particular, the means 4 for checking said condition can also comprise a probe or a sensor 8 for a tactile interaction, which is configured to register a pressure exerted by the user on the skin site lying above the implant 1 or knocking, for example in the form of a knocking pattern (the pressure exerted by the user is passed on to the probe or sensor 8 through the skin layers and optionally the body tissue lying beneath it), so that the user can actuate the implant directly by actuating the sensor 8. The sensor 8 for a tactile interaction can be formed by a suitably configured pressure or tactile sensor, or also by a sensor which detects vibrations of the skin as a result of knocking, that is to say, for example, a microphone or an acceleration sensor.The active medical implant 1 further comprises communication means 10 for transmitting a first message N 1 to a hearing instrument 20 and for receiving a second message N 2 from said hearing instrument 20. The communication means 10 are preferably matched to the specific configuration of the implant 1, in particular to its positioning in the body of the user (and to the depth below the skin). In the present case, the communication means 10 are provided by an RF antenna 12, wherein communication means for IR or MW transmission or also transmission by ultrasound (in each case not shown) would also be conceivable.Moreover, the active medical implant 1 has means 14 for activating and / or modifying said medical function. These means 14 comprise in the present case control logic 16 which, in a manner to be described below, controls the above-mentioned signals. The condition for activating and / or changing the medical function is checked and recorded, as well as the communication with the hearing instrument 20 is controlled by the implant 1, and finally the medical function, i.e. the insulin release, is controlled and optionally regulated. The means 14 therefore also comprise a pumping device 18 which regulates the quantity of insulin dispensed from the reservoir 5 according to the specifications of the control logic 16.The hearing instrument 20 is designed in the present case as a hearing device 22, which is configured to provide a hearing weakness of the user. For this purpose, the hearing device 22 has at least one input transducer 24, which is designed as a microphone and generates an electrical input signal 25 from an ambient sound (not shown). The input signal 25 is converted by a control unit 26, which has, inter alia, a signal processor (not shown 9, into an electrical output signal 27 which is fed to an electro-acoustic output transducer 28 and is converted there into an output sound signal (not shown). The output transducer 28 is provided in the present case by a loudspeaker 29, but could also be provided by a bone guide listener or the like. The output converter 28 is also configured to output a user request to the user in response to the second message N 2 (for example in the form of a voice message automatically generated by the control unit 26).The hearing instrument 20 further comprises communication means 30 for receiving the first message N 1 from the implant 1 and for transmitting the second message N 2 to the implant 1. The communication means 30 are provided in the present case by an RF antenna 32. The hearing instrument 20 also has means 34 for inputting a response to the user request. These means 34 comprise the input transducer 24 (response as voice input by the user), but can also comprise a button or another tactile operating element (not shown in each case) on the hearing device.The described configuration of the implant 1 and of the hearing instrument 20 allows the implant 1 to be controlled by means of the hearing instrument 20.FIG. 2 shows a block diagram of a method of controlling the implant 1 in this way using the hearing instrument 20 according to FIG. 1. In a first step S 1, a condition B for activating and / or changing a medical function of the implant 1 is checked by the means 4. This can be done, for example, by measuring the blood sugar level of the user by means of the associated measuring device 6, and / or by means of the tactile interaction sensor 8, which registers a manual actuation by the user.If the condition B for an activation / change of the medical function of the implant 1 is fulfilled (y) and if a corresponding blood sugar level or an actuation by the user is thus present, in a second step S 2 a corresponding first message N 1 is generated by the control logic 14 of the implant 1 and transmitted via the communication means 10 to the hearing instrument 20 and received there by the associated communication means 30. The first message N 1 preferably contains information about a proposed or imminent activation / change of the medical function, i.e. e.g. about an intended delivery of insulin (or an increase in the delivery quantity).In the hearing instrument 20, in the next step S 3 a user request An in the form of an automatic voice message is generated by the control unit 26 on the basis of the first message N 1, and is output to the user via the output converter 28. The user request contains an indication about the proposed or imminent activation / change of the medical function, as well as further information about a time period for the response (e.g. 5 seconds) and an explanation as to whether the activation / change of the medical function is deemed to be accepted in the absence of the response (i.e. the user thus has to actively insert a veto) or is discarded (i.e. an active confirmation of the user is required).If a response R is input by the user, for example as a voice command, which is detected via the input transducer 24, or via a tactile operating element (not shown) of the hearing instrument 1, or if the time period for the response has elapsed, then in a step S 4 a corresponding second message N 2 is generated by the control unit 26 and transmitted via the communication means 30 to the implant 1 and received there by the corresponding communication means 10.If the second message N 2 contains information about an (active) approval of the user for a proposed activation / change of the medical function, or information about a failure of a veto against this activation / change within the time period, then in a step S 5, the medical function F, i.e. in the present case the insulin delivery, is initiated by the corresponding means 14, i.e. the pump device 18 is actuated by the control logic 16. In the event of a change in the medical function F, an operating parameter of an already running medical function can be changed, that is to say, for example, an insulin delivery quantity per unit time.Although the invention has been illustrated and described in more detail by the preferred exemplary embodiment, the invention is not restricted by the disclosed examples and other variations can be derived therefrom by the person skilled in the art without departing from the scope of protection of the invention.List of reference characters1 Active medical implant 2 Insulin pump 4 Means for checking a condition 5 Reservoir (for insulin) 6 Measuring device for a blood sugar level 8 Sensor for a tactile interaction 10 Communication means 12 RF antenna 14 Means for activating / changing a med. Function 16 control logic 18 pump device 20 hearing instrument 22 hearing device 24 input transducer 25 input signal 26 control unit 27 output signal 28 (electro-acoustic) output transducer 29 loudspeaker 30 communication means 32 RF antenna 34 means for inputting a response to a user request An user request B condition F medical function N1 / 2 first / second message R response S1-5 steps (of the method)

Claims

Method for controlling an active medical implant (1) by a hearing instrument (20), wherein a condition (B) for an activation and / or change of a medical function (F) is checked by the active medical implant (1), and a corresponding first message (N1) is transmitted to the hearing instrument (20) on the occurrence of the condition (B), wherein a user request (An) regarding the activation and / or change of the medical function (F) is output to a user of the active medical implant (1) by an electro-acoustic output transducer (28) of the hearing instrument (20) on the basis of the first message (N1), wherein a corresponding second message (N2) is transmitted from the hearing instrument (20) to the active medical implant (1) on the basis of a reaction of the user to the user request (An), and wherein the activation and / or change of the medical function (F) of the active medical implant (1) is performed on the basis of the second message (N2) about the reaction of the user to the user request (An).Method according to claim 1, wherein as condition (B) for the activation and / or change of the medical function (F) - a manual interaction by the user is determined, and / or - a physiological parameter is measured, and / or - a physical reaction of the user is detected, and / or - an activity of the user of the user is determined, and / or - a location position of the user is determined, and / or - a time is determined.Method according to claim 1 or claim 2, wherein a physiological parameter is measured by the hearing instrument (20) and / or a further external device worn on the body of the user, wherein said physiological parameter or a physiological information derived from the physiological parameter is transmitted from the hearing instrument (20) or from the external device to the active medical implant (1), and wherein in the active medical implant (1) the condition for the activation and / or change of the medical function (F) is also checked on the basis of said physiological parameter measured by the hearing instrument (20) or from the external device and / or on the basis of said physiological information.Method according to one of the preceding claims, wherein the first message (N1) contains information about the medical function (F) of the active medical implant (1) to be activated and / or changed.The method of claim 4, wherein the first message (N1) additionally includes a time-delay for a response (R) to the user request (An).Method according to one of the preceding claims, wherein the first message (N1) and / or the second message (N2) are transmitted between the active medical implant (1) and the hearing instrument (20) by means of one of the following transmission paths: - electromagnetic waves at radio frequency and / or in the infrared range and / or in the microwave range, - magnetic induction, - ultrasound.Method according to one of the preceding claims, wherein the following devices are given as the active medical implant (1): - an insulin pump (2) or - an implanted medicament pump or - an artificial sphincter or - a device for controlling a blood flow in a corpuscle or - a device for electrically stimulating tissue or - a device for directly and / or indirectly controlling an organ movement or - a device for stimulating and / or inhibiting a production of a gland secretion or - a device for suppressing shakes and / or pain by nerve stimulation.Method according to one of the preceding claims, wherein an operating parameter of the active medical implant (1) is changed as a change in the medical function (F), and / or a medical function (F) of the active medical implant (1) is suspended.Method according to one of the preceding claims, wherein in the user request (An) information about an activation and / or change of the medical function (F) proposed by the active medical implant (1) is output, and wherein the proposed activation and / or change takes place only upon confirmation of the user request (An).Method according to one of Claims 1 to 8, wherein information about an activation and / or change of the medical function (F) imminent in the active medical implant (1) is issued in the user request (An), and wherein the activation and / or change only occurs if no Veto occurs as a response (R) to the user request (An).Method according to one of Claims 9 or 10, wherein the second message (N2) is generated - after confirmation of the proposed activation and / or change of the medical function (F) or - after a delay of the imminent activation and / or change of the medical function (F) or - after a time delay has elapsed for a response to the user request (An), and in each case contains information corresponding thereto.Hearing instrument (20) comprising - an electroacoustic output transducer (28) configured to output a user request (An) to a user, - means (34) for inputting a response to said user request (An), - communication means (30) configured to receive a message from an active medical implant (1) and to transmit a message to said active medical implant (1), and - a control unit (26), wherein the hearing instrument (20) is configured to - receive from the active medical implant (1) a first message (N1) regarding an activation and / or change of a medical function (F) thereof, - output a corresponding user request (An) to the user on the basis of the first message (F) via the output transducer (28), and - based on a reaction of the user to said user request (An) detected via said input means (34), to send a corresponding second message (N2) to the active medical implant (1).Active medical implant (1) comprising: - means (4) for checking a condition (B) for an activation and / or change of a medical function (F), - communication means (10) which are configured to transmit a first message (F) about said activation and / or change to a hearing instrument (20) and to receive a second message (N2) regarding a reaction of a user of the hearing instrument (20) to a user request (An) issued regarding the activation and / or change, and - means (14) for activating and / or changing the medical function (F) depending on the received second message (N2).

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