CN102917636A - Analyte sensor having a slot antenna - Google Patents

Abstract

The invention relates to a medical device (111) for detecting at least one analyte in a bodily fluid. The medical device (111) comprises at least one implantable functional element (117) and at least one controller (140) having at least one electronic component (130, 132, 134, 136). The functional element (117) can be connected to the controller (140). The controller (140) comprises a housing (142) having at least one metal housing (144). The controller (140) comprises at least one wireless communication device (176). The metal housing (144) comprises at least one slot structure (148). The communication device (176) is designed to communicate with at least one external device by means of the slot structure (148).

Description

Analyte sensor with slot antenna

technical field

The invention relates to a medical device for performing at least one medical function on the human or animal body. In particular, the invention relates to a sensor device for monitoring at least one individual function, in particular for identifying at least one analyte in a body fluid. Furthermore, the invention relates to a method for producing a medical device for performing at least one medical function on the human or animal body, and in particular to a method for producing a medical device for monitoring at least one individual function, in particular for identifying A method of a sensor device for at least one analyte in a body fluid, in particular a method for producing a medical device according to the invention. Such medical devices and in particular sensor devices are generally used in therapeutic medicine and diagnostics, for example to influence and/or monitor body functions. An example is continuous or discontinuous monitoring of the analyte concentration in at least one bodily fluid, such as interstitial fluid or blood. As analytes to be monitored, glucose, cholesterol, lactate, metabolites or other types of analytes or combinations of analytes generally come into consideration, for example. But in principle the term "analyte" should be understood broadly and may include one or more chemical substances. In principle, the invention can generally also be applied to other medical devices and devices in the field of diagnostics, therapeutics or surgery, since in principle, for example, at least one arbitrary body function can be detected by means of a sensor device instead of one or more Analytes and/or in principle any bio-physical sensors (for example for blood pressure, temperature or movement) and/or actuators for influencing at least one body state can be embodied according to the invention.

Background technique

The monitoring of specific body functions, especially the monitoring of one or more concentrations of specific analytes plays an important role in the prevention and treatment of different diseases. Without limiting other possible applications, the invention is described below with reference to blood glucose monitoring. In principle, however, the invention can be transferred to other types of analytes and/or to the monitoring and/or influencing of other types of body functions.

A method and a device for monitoring the hemodynamic state of a patient are known from US 6,409,675 B1. In particular, a monitoring device is described here. Furthermore the use of slot antennas is suggested.

A system for measuring internal physiological parameters of a medical patient is known from US 2007/0167867 A1. In particular, implanted sensor modules are used here. The telemetry signal is transmitted here in the form of an NIR signal. The implant has a gold-plated electrode surface with a slit structure for avoiding eddy currents. A central opening is provided in this slot structure, which is free of metallization and allows the transmission of infrared signals.

In US 5,394,882 a wireless monitoring system is described having a first unit for detecting movement of a patient and a second unit for receiving a signal of the first unit. In particular, an exemplary embodiment of a first unit is described here, in which a disk-shaped slot antenna is used.

A monitoring device for analytes is known from EP 2 187 555 A1. In particular, the structure of the corresponding sensor electronics is described here.

An implantable medical device is disclosed in US 2009/0182426 A1. In particular, antenna structures are described here. In this case, the use of a metal housing is known, wherein an antenna carrier made of a dielectric material extends around the housing on the outside, with the antenna embedded in the antenna carrier.

In addition to so-called point measurements, in which samples of bodily fluids are taken from the user in a targeted manner and the analyte concentration checked, continuous measurements are increasingly being established during analyte monitoring. Thus for example continuous glucose measurement in the interstitium (also called continuous monitoring, CM) has recently been established as an important method for managing, monitoring and controlling eg diabetic conditions. This continuous monitoring is currently in many cases limited to type 1 diabetics, ie diabetics who usually also carry an insulin pump. At the same time, implanted electrochemical sensors are generally used directly here, which are often also called needle sensors (Needle sensors). Type Sensors, NTS). Here, the active sensor area is placed directly on the measuring site, which is generally arranged in the interstitial tissue, and converts the glucose into a glucose-concentration-dependent and can be used as the charge of the measured parameter. Examples of such transdermal measurement systems are described in US 6,360,888 B1 or in US 2008/0242962 A1.

Current continuous monitoring systems are thus generally transdermal systems. This means that the actual sensors are placed under the user's skin. However, the analysis and control components (also known as patches) of the system are generally located outside the user's body, that is, outside the human or animal body. Here, the sensor is generally applied by means of an insertion instrument, which is also in the US 6,360,888 B1 is exemplarily described. Other types of insertion instruments are also known. The on-board duration of the sensor is typically about one week. Afterwards, influences such as consumption of the enzyme in vivo and/or encapsulation with a coating generally reduce the sensitivity of the sensor, and thus a sensor failure can be expected. Extended carry duration is a current area of development. However, this means that the sensor and optionally components directly connected to the sensor, such as the insertion needle, should be designed as exchangeable components. Sensors and optionally other replaceable components are therefore generally so-called disposable parts (disposables). The analysis and control components of the system are in most cases reused. The evaluation and control components are therefore generally designed as so-called reusable components (reusables).

The prior art separation of at least one disposable part and at least one reusable part also has the background that the fully or partially implantable component can be sterilized according to current standards for use on humans and/or animals. In the case of enzyme-based electrochemical glucose sensors, the enzyme embedded in the electrode is in contact with the interstitium, that is to say the electrode is offen. Therefore, chemical or thermal disinfection is ruled out, since during said chemical or thermal disinfection the enzymes of the electrodes would be damaged. Therefore, in each case only radiation disinfection can be used. However, at the required radiation doses (typically 25 kGy), electronic components cannot in any case withstand direct irradiation, for example with beta radiation. However, the separation into a disposable part and a reusable part results in the known devices: only the disposable part has to be sterilized, whereas the reusable part has to be coupled to the disposable part only after sterilization.

However, the separation of disposable and reusable parts connected by a plug connection has a number of disadvantages. Thus, for example, electrochemical glucose sensors mostly work according to the potentiostatic principle. In this case, the reference electrodes used generally only allow current-free operation. But this requires a very high ohmic design and good insulation of the whole potentiostat. However, the system is permanently or completely or partly (especially the sensor) located in the body tissue during use and thus is exposed to a water-containing environment and/or is permanently exposed to very high relative air humidity (especially reusable parts ). This promotes the formation of parasitic leakage resistance and/or leakage current. The whole structure should therefore be properly sealed. However, in the case of pluggable connections between disposable and reusable parts, the plug connection in particular forms the weak point of the insulation, since parasitic leakage resistances and leakage currents can easily be formed in the area of the plug connection .

It may therefore be preferable to completely encapsulate the disposable and the reusable or to eliminate the separation between the disposable and the reusable. However, as already mentioned above, the control electronics must then be protected in a suitable manner against sterilizing ionizing radiation. by US 6,565,509 B1 For example an analyte monitor is known which comprises a sensor, a sensor control unit and a display unit. In particular, it is also proposed here to dispense with an electrical contact between the sensor and the sensor control unit. However, this device has the decisive disadvantage that damage to the control device can occur during the radiation sterilization of the device. In contrast, in EP 1 178 841 B1 describes a method for protecting medical systems including sensitive semiconductor components against high-energy radiation sterilization. It is proposed here to accommodate the medical device in a metallic protective housing which is coupled gas-tight to a carrier substrate carrying sensitive semiconductor components. In principle, however, such shielding has a number of disadvantages in known systems. For example, in known electrochemical glucose continuous monitoring systems the sensor is located in the interstitium and the measured value processing and storage components are located outside the body, directly on the skin but under the clothing. Continuously or discontinuously detected glucose measurement values are intermediately stored and, if required, transmitted eg by radio (high frequency transmission, RF) to an external device, such as a data manager, PDA (Personal Digital Assistant), PC or mobile communication device, and be visually represented and/or further processed there. Fully implanted sensors such as analyte sensors may also operate via radio. However, as mentioned above, the invention can in principle also be applied to other types of medical devices comprising at least one implanted and/or implantable element, such as bio-physical sensors in general, such as for example cardiac pacemakers, Invasive actuators for insulin pumps, drug metering systems, and more. Due to the gas-tight insulation of the actual potentiostatic measuring system in the case of a glucose sensor, communication via electromagnetic waves is particularly suitable. Optical systems are also suitable for communication in principle, but have the disadvantage of requiring a visual connection to the receiver, which is not provided, especially in the subcutaneous area or under clothing. However, an essential component of a radio system is an antenna for receiving or for radiating electromagnetic waves. However, these antennas are typically implemented as metallic structures in the air. In particular, dipole antennas and/or semi-dipole antennas are used here in various embodiments for the given application. Such an anisotropic antenna functions bidirectionally as a transmitting and receiving antenna. Antennas can be shaped and sized to match specific frequencies and tasks. However, as in EP 1 As in 178 841 B1, a metal protective casing is provided, so that the antenna is generally also completely shielded by a metal screen. Electromagnetic waves neither enter nor exit through this metal screen functioning as a Faraday cage. The metal shielding required for shielding against ionizing radiation during sterilization therefore has a negative influence on the communication properties of the sensor element. However, if the shielding is removed again after sterilization, this must be done under sterile conditions in order to avoid recontamination again. However, the production of electronic components under sterile conditions is enormously expensive.

Furthermore, a large number of communication systems for medical and non-medical purposes are known in principle from the prior art. In Christian Floerkemeier and Frank Siegemund: Improving The Effectiveness of Medical Treatment with Pervasive Computing Technologies, Workshop on Ubiquitous Computing for Pervasive Healthcare Applications at So-called "smart packaging" is described in Ubicomp 2003, Seattle, Washington, October 2003. The smart package includes the monitoring of the consumption of the medicament in the medicament package and the communication of the current consumption status to the mobile phone via the electronic bluetooth communication module.

Furthermore, so-called “slot antennas” are known in principle from other fields of prior art, for example from aeronautics and aerospace technology. For example in W.Ren: Compact Dual-Band Slot Antenna for 2.4/5 GHz WLAN Applications, Progress In Electromagnetics Research B, Vol.8, 319-327, 2008 describe that slot antennas are integrated into high-frequency circuits for WLAN communication in the form of square or circular annular slits.

Contents of the invention

It is therefore the object of the present invention to specify a medical device, in particular a sensor device, and a method for producing a medical device, in particular a sensor device, which avoid the above-mentioned disadvantages of known medical devices and methods. In particular, the medical device should be easily sterilizable by means of conventional sterilization methods without damage to sensitive electronic components of the medical device occurring in this case. At the same time, however, the medical device should be designed to be able to communicate wirelessly with other devices.

This object is solved by the subject-matter of the invention according to the independent claims. Advantageous developments of the invention which can be realized individually or in combination are indicated in the dependent claims.

The expressions "comprises", "comprises" or "has" used below and grammatical variations of these expressions can generally be understood that the components or elements introduced by these expressions can be exclusively included without setting other elements, or in addition to In addition to the components or elements introduced by these expressions, one or more other components and/or elements may also be included. Thus, for example, the expressions "A contains B", "A contains B" and "A has B" can be understood as meaning that A contains only B, that A is B or that A consists of B, or that in addition to B A also contains one or various other components and/or elements.

In a first aspect of the invention, a medical device for performing at least one medical function on the human or animal body is proposed. Within the scope of the present invention, a medical device is generally to be understood as a device designed to perform a medical function. A medical function can generally be understood as a function having a therapeutic and/or surgical and/or diagnostic effect. The device is thus designed, for example, to influence and/or detect at least one individual function of the human or animal body. For example, this may be a physiological and/or physical state of the body. For detecting body functions, the device can, for example, be completely or partially designed as a sensor device and/or include a sensor device. In order to influence body functions, the device can, for example, be completely or partially formed as an actuator and/or comprise at least one actuator, wherein the actuator can apply at least one stimulus to the body or a part of the body and/or otherwise influence the body. The actuator can be designed, for example, to apply physical and/or chemical stimuli to the body. Thus, for example, the actuator can apply electrical stimulation to the body, for example with one or more stimulation electrodes. Thus, for example, the device can be designed completely or partially as a cardiac pacemaker with at least one electrical actuator in the form of one or more stimulating electrodes. Alternatively or additionally, the device can also apply chemical stimuli, for example. The device can thus be designed, for example, completely or partially as a drug delivery device and can have, for example, at least one actuator in the form of a drug pump and/or in the form of an active substance dispenser.

Without limiting other possible configurations, the invention is basically described below with reference to a medical device which is completely or partially formed as a sensor device or which includes at least one sensor device. The sensor device can generally be designed for monitoring at least one body function and is particularly preferably designed for the qualitative and/or quantitative identification of at least one analyte in a bodily fluid.

The monitoring of body functions can in principle be based on one or more physical and/or chemical and/or biological detection methods or measurement methods. For example, it can be an electrochemical measurement and/or an optical measurement. Thereby, for example, one or more analytes can be identified chemically, electrochemically or optically.

Within the scope of the present invention, the term "body function" can in principle be understood in the sense of one or more detectable properties and/or measured variables of the human or animal body. In particular it may be one or more properties that characterize the state of health of the body. In particular, a body function may be at least one physiological function and/or at least one physiological characteristic of the body.

Examples of possible body functions that can be detected alone, in any combination, or in combination with other body functions are: blood pressure; pressure of at least one other body fluid and/or at least one organ of the body; heart rate; respiratory rate; body or the temperature of a part of the body; the presence or absence or concentration of one or more antibodies in at least one body fluid (especially blood); the concentration of at least one analyte in at least one body fluid, wherein the Concentrations can be detected qualitatively (presence or absence of analyte) and/or quantitatively.

Without limiting the detection of other possible body functions, the invention is described below substantially with reference to the qualitative and/or quantitative identification of at least one analyte in at least one body fluid. For possible expansions of the analytes, reference can generally be made to the description above. In particular, the analyte may comprise at least one metabolite, for example glucose and/or lactate and/or cholesterol. The body fluid can especially be selected from the group consisting of blood, interstitial fluid, saliva and urine. In particular, the sensor device can be designed for the continuous qualitative and/or quantitative identification of at least one analyte. The sensor device can therefore be used in particular in the context of continuous monitoring, that is to say long-term monitoring over a period of several hours to days or even weeks or months. In principle, however, other configurations are also possible.

The medical device includes at least one implantable functional element. In particular, the sensor device can comprise at least one implantable sensor element. Furthermore, the medical device includes at least one operating device with at least one electronic component. Here, the functional element can be fully or partially implantable. For example, the active and/or sensitive portion of the functional element may be implanted in the user's body tissue, from which the leads may protrude. In principle, however, other expansions, such as fully implanted expansions, are also possible.

Within the scope of the present invention, a functional element is generally to be understood as an element in a medical device that can perform at least one medical function either alone or in cooperation with other elements of the medical device. In this case, for example, a sensor can be a sensor which can detect a body function or which can generate at least one signal from which a conclusion can be drawn, for example. For example, electrical and/or optical signals can be used in this case. Alternatively or additionally, this can be an active element, wherein the active element is designed, for example, to apply one or more of the above-mentioned stimuli to the body or a part of the body, for example one or more electrical stimuli and/or Or one or more physiological stimuli, for example in the form of one or more medications.

The term "implantable" within the scope of the present invention is generally to be understood as meaning that the functional element can be completely or partially introduced into the body tissue of the human or animal body. The introduction can take place, for example, percutaneously or subcutaneously, for example in the context of surgery. The term "implantable" therefore includes that the functional element should first be dimensioned accordingly for introduction into body tissue. Thus, the functional element or, for example, the implantable part of the functional element can be designed such that the implantable part has a volume of not more than 3 cm ³ , preferably not more than 1 cm ³ . Furthermore, the functional element should have biocompatible properties, at least at the surface of the functional element. The functional element should thus not dissolve and/or should not release toxic substances, such as heavy metals, when it comes into contact with body fluids and/or body tissues. To produce this biocompatibility, corresponding passivation structures and/or coatings can also be provided, for example.

The sensor element can, for example, have at least one sensor chemistry which changes at least one identifiable property, for example an electrochemically and/or optically identifiable property, in the presence of at least one analyte. As will be described in more detail below, it is particularly preferred that the implantable sensor element is a sensor element for the electrochemical identification of at least one analyte, for example having at least two, preferably at least three electrodes (e.g. working electrode and reference and/or counter electrode) sensor element. In principle, however, other configurations are also possible.

In principle, the actuation device is used to support the functional element during the execution of the medical function and/or to activate the functional element for the execution of the medical function. If the functional element, for example, applies at least one stimulus to the body, for example, an actuation device can be provided which, for example, predetermines the moment and/or the intensity and/or the duration of the stimulus to the body. Optionally, the manipulation device may also provide energy for applying said stimulus. If the functional element is designed entirely or partially as a sensor element, the actuation device can, for example, detect measured values and/or signals provided by the sensor element and possibly make them available for evaluation. For this purpose, the evaluation device can include, for example, a measurement signal processing device, in particular a so-called analog front end (AFE), and/or a storage unit.

Furthermore, the actuation device can generally also include an energy supply device. In particular, the at least one electronic component may comprise at least one sensitive semiconductor component, for example an operational amplifier and/or another type of semiconductor component. In addition, electronic devices may also include application specific integrated circuits (ASICs). In general, the electronic device may be any electronic device capable of withstanding radiation damage when sterilized by ionizing radiation. In general, an electronic device is to be understood as any device, especially a semiconductor device, capable of performing at least one electronic function, such as a rectifier function, an amplifier function, a transistor function, a memory function, a logic function, a precision direct voltage source and/or a direct current source functions, clock functions, regulating functions or other types of electronic functions. Combination electronic devices, ie devices having more than one function, may also be used.

Functional elements, in particular sensor elements, can be connected to the actuation device. Here, "connectable" within the scope of the present invention can generally be understood as meaning the possibility of establishing a connection, in particular an electrical connection and/or a mechanical connection, between interconnectable elements, for example in such a way that they are interconnectable One or both of the elements comprise one or more connection elements, such as at least one plug connector or the like. Here, the term “connectable” also includes the possibility of elements that can be connected to each other, in this case in particular functional elements (in particular sensor elements) and actuation devices are already reversibly or also permanently connected to each other. The connection can, for example, be via a fixed or permanent connection, as will be described in more detail below, that is to say via a connection that cannot be released by the user, at least not without damage. For example, the connection can take place via a cable or via a part of the functional element, in particular the sensor element itself. The sensor element can be formed, for example, as a flexible foil sensor element, at one end of which the electrodes of the sensor element are arranged and whose other end can be connected or is already connected to the actuation device. Different expansion scenarios are possible.

The operating device has a housing with at least one metal housing. This means that the actuating device is completely or partially surrounded by a housing which shields the actuating device from environmental influences, in particular from humidity. A housing can therefore generally be understood as an element which has a shielding effect at least against mechanical or chemical influences and has at least one completely or partially closed interior space in which at least one element to be protected is accommodated. For its part, the housing has at least one metal housing, that is to say a housing that is completely or partially produced from at least one metallic material. The housing of the actuating device can here be completely formed as a metal housing, or the metal housing can only form a part of the entire housing. Various configurations are possible and are described in more detail below. A metal housing is to be understood here as a housing that is completely or partially produced from at least one metallic material. The metal casing here shall be completely, mainly or at least partly made of at least one metallic material and/or shall preferably contain no or only a small amount of non-metallic In addition to the metal component, at least one metal material may also be included. Thus, for example, at least one metallic material can also be introduced as filler into at least one non-metallic material, for example a plastic material. Alternatively or additionally, the metallic housing can also comprise at least one layer structure with at least one non-metallic layer and at least one metallic material layer. For example layered structures can be used. For example, various properties can be improved or even optimized, such as the sealing properties against ingress of media such as moisture and the shielding properties, for example, against electromagnetic radiation and/or against ionizing radiation. For example, the metal housing can have a layered structure, in which case one or more metal layers are combined with one or more plastic layers, for example in such a way that they are used as a seal and/or also as corrosion protection And/or a plastic layer for improved biocompatibility as the outermost layer. The metal may comprise, for example, aluminum, copper, iron, lead or other metals or combinations of these and/or other metals (eg mixtures and/or alloys and/or layer structures with layers of different metals). For example, the metal casing may have a thickness of at least 0.5 mm, preferably at least 1 mm or even at least 2 mm. In particular, the metal housing can have an overall thickness of between 0.5 mm and 10 mm, preferably a thickness of 1 mm to 5 mm, for example a thickness of 2 mm to 3 mm. The thickness can depend, for example, on material choice. If a plurality of layers is provided, the individual layers can, for example, each have a thickness of 0.05 mm to 8 mm, for example 0.1 mm to 5 mm and particularly preferably 0.2 mm to 3 mm. With this design, in particular a compromise can be achieved between the requirements of shielding thickness and radiation attenuation on the one hand and the smallest possible volume and/or weight on the other hand.

The operating device also has at least one wireless communication device. Here, a wireless communication device can be understood as a device that enables a control device to communicate with a medical device, in particular a device other than a sensor device, in a one-way or two-way manner. In particular, the communication device can be designed for electromagnetic communication. For example, the actuating device can be designed to detect electrical signals of the sensor elements and/or to temporarily store measured values. Preprocessing or at least partial processing of the signals and/or measured values can also take place within the operating device. The measured values can then be exchanged via the wireless communication device eg with other devices, eg with external devices such as data managers, PDAs, mobile communication devices, PCs, laptops or networks. Alternatively or additionally, control commands can be received, for example in that the operating device receives specific commands from an external device. Here, a wireless communication device can be understood as a device designed to exchange data and/or commands via a wireless path. For example, a wireless communication device may comprise a device for radio communication, ie communication via electromagnetic waves in the high frequency range, eg the gigahertz range. Alternatively or additionally, wireless communication is also possible, for example via inductive and/or electrical coupling. In particular, wireless communication can be carried out in such a way that no galvanic connection (galvanische Verbindung). This is advantageous in particular in the case of electrochemical sensor devices with at least one invasive electrochemical sensor, wherein preferably the sensor electrode is the only galvanic connection to the sensor device and there are no other galvanic connections to the sensor device.

In order to solve the above-mentioned technical dilemma of at least partial shielding of the control device by the metal casing, especially the shielding of sensitive electronic components by the metal casing, while having the possibility of maintaining a wireless communication connection in the direction of radiation through the metal casing, it is proposed A metal housing with at least one slot structure is formed. A slot structure is to be understood here as a structure having at least one slot in the metal housing, that is to say a slightly elongated opening and/or break in the metal housing, which has a width and a length, wherein the width is significantly lower than its length. For example, at least one slot can have a length that is at least 3 times, in particular at least 5 times or even at least 10 times or preferably even at least 20 times its width. The width of the gap is preferably less than 5 mm, particularly preferably 3 mm or less or even only 1 mm or less. As explained in more detail below, if a slot is used as a component of a slot antenna, the aspect ratio of the slot, as a ratio of width to length, can depend, inter alia, on the frequency used and/or on the radiation characteristics. The slots can be formed as simple, straight slots. Alternatively, the slot can also be curved, curved or angled, with one or more straight or curved sections. For example, meander structures are possible. Alternatively or additionally, the slot structure can also be designed completely or partially circular, elliptical or helical. In addition, a branching structure of the slot can also be provided, with one or more branches. In particular, the above-mentioned conditions of the gap geometry can relate to one or more or even all segments of the bifurcation structure, wherein one or more segments which do not satisfy the stated conditions can also be provided, in particular one or more segments which are not configured as A segment of a gap, other than one or more segments constructed as a gap. The at least one slot is therefore preferably a break in the dielectric case of the metal housing, in particular if the slot is part of a slot antenna, as will be explained in more detail below. Via this opening, electromagnetic waves can radiate from a predetermined conducting structure, in this case for example from a metal housing.

The communication device is designed to communicate with at least one external device through the slot structure. In this case, communication via the slot structure is to be understood as meaning, on the one hand, that the communication takes place through the slot structure, for example in that a signal is transmitted through the slot structure from the interior of the housing into the outside area or is emitted directly from the slot structure, for example in the manner is to arrange at least one emitter in the slot structure. Alternatively or additionally, the term “communication via the slot structure” may also include that the slot structure itself participates in the communication, so that the communication takes place, for example, by means of the slot structure. Examples are also explained in more detail below.

Communication with external devices should generally take place preferably entirely wireless, especially in order to avoid galvanic coupling. As mentioned above, the housing should comprise at least one metal housing. In this case, the actuation device is preferably at least partially, in particular completely, arranged in the metal housing. This can be done, for example, in that at least the electronic component, preferably at least one radiation-sensitive electronic semiconductor component, is arranged completely or partially in the metal housing.

For example, the metal housing can completely or partially surround the actuation device. Thus, for example, the metal housing can be arranged relative to the electronic component in such a way that the metal housing covers at least one spatial angle of at least 2π, preferably at least 2.5π spatial angle, particularly preferably at least 3 spatial angle, around the electronic component as viewed from the electronic component, And ideally a space angle of at least 3.5π or even 4π.

In particular, the sensor element can comprise, as described above, at least one electrochemical sensor with at least two, preferably at least three, sensor electrodes which are arranged in the body tissue of the user in the implanted state of the sensor element. The actuating device can then include, in particular, at least one potentiostat and/or at least one primary amplifier which is connectable or connected to the sensor electrodes. One or more of these components can in particular form a so-called analog front end (AFE). In this context, a potentiostat is to be understood within the scope of the present invention as an electronic control amplifier with which the potential of one of the electrodes can be adjusted to a desired value. For example, a potentiostat may include a precision DC voltage source. For example, a potentiostat can be designed such that the current flow between the working electrode of the sensor element and the counter electrode of the sensor element is adjusted in such a way that a desired potential is reached. Here, the reference electrode (whose potential is in the potential series (elektrochemische Spannungsreihe) can be used as a reference point. A primary amplifier can in principle be understood as any amplifier to which the signals of the sensor electrodes are applied directly or indirectly. In particular, this can be a high-resistance input stage, wherein the amplifier can generally have an amplification factor greater than 1, less than 1 or also equal to 1. The input stage may have an input resistance that is relatively high, such as in the range of greater than 100 kiloohms, such as greater than 1 million ohms, or even greater than 1 gigaohms. In particular, the sensor device can be designed in such a way that the potentiostat and/or the primary amplifier, which can be formed completely or partially as a semiconductor component, can be arranged in a metal housing. Alternatively or additionally, however, other electronic components can also be arranged in the metal housing, for example memory components, operational amplifiers, transistors or other electronic components. Arrangement in a metal housing is generally understood here as an arrangement in which the metal housing shields the contained components in at least one direction so that ionizing radiation, as used for disinfection, cannot proceed to these components. For example, the metal housing can have convex and concave sides, wherein the components can eg be arranged on the concave side of the metal housing. For example, the metal housing can form a metal shell shielding the actuation device in at least one direction. A metal shell is to be understood here as a shell structure that is open in one direction. In particular, the metal housing can be coupled in a gas-tight manner to a carrier element, in particular to a circuit board, wherein the carrier element carries at least one electronic component of the actuating device. For example, the carrier element can be designed as a circuit carrier, in particular as a circuit board, on which the electronics are applied, wherein the metal housing is coupled to the circuit carrier, in particular to the circuit board. Here, a gas-tight coupling is to be understood as a coupling that prevents the penetration of moisture into the interspace between the carrier element and the metal housing. Such a gas-tight coupling can take place, for example, by casting and/or gluing. The metal housing can thus shield the circuit board, for example, in one direction, for example in the direction that serves as the direction of incidence during sterilization.

The functional element, preferably the sensor element, in particular the sensor electrode, can preferably be arranged completely or partially outside the housing, for example for implantation in body tissue. In principle, the functional element, in particular the sensor element, can be connected or connected, for example releasably, to the actuation device, for example via at least one plug connection. Preferably, however, the functional element, in particular the sensor element, is fixedly connectable or connectable to the actuation device. This means that, as described above, the functional element, in particular the sensor element, is preferably connected to the actuation device without a plug connection and cannot be detached from the actuation device by the user without damage. For example, a functional element, in particular a sensor element, can be permanently wired to the actuation device. In this way, a gas-tight insulation can be achieved and/or leakage currents and/or leakage resistances can be largely minimized. The actuating device and the functional elements, in particular the sensor elements, in particular can be designed overall as a disposable part or part, for example for a carrying period of several weeks to several days.

As mentioned above, the communication device is designed to communicate with at least one external device through the slot structure. As also explained above, the communication can take place in principle in any manner, wherein the slot structure participates in the communication. For example, at least one communication element of the communication device can be introduced into the slot structure and/or at least one slot of the slot structure. For example, at least one coil can be introduced into the slot structure, via which coil communication with external devices is possible, wherein the transmission of electromagnetic waves and/or, for example inductive coupling, takes place through the slot structure or into the slot structure. Therefore, instead of or in addition to the communication via electromagnetic radiation in the far field, ie at distances above twice the electromagnetic wavelength, for example also an inductive and/or magnetic and/or capacitive coupling by means of at least one slot structure is also considered For example, by introducing one or more inductive and/or magnetic and/or capacitive coupling elements into at least one slot structure in the metal housing or in the vicinity thereof.

However, it is particularly preferred if the slot structure comprises at least one slot antenna. In particular, the communication device can be designed to carry out and/or implement wireless and/or electromagnetic communication, for example radio communication, by means of a slot antenna. In particular, the electromagnetic communication can be such that electromagnetic waves originate from the slot antenna and/or are received by the slot antenna, in particular in the region of free-field radiation, according to Maxwell's field equations. The communication device and the slot antenna can therefore be designed and interact in such a way that the slot antenna is used as an antenna for transmitting and/or receiving electromagnetic waves. Thus, the proposed medical device and in particular the sensor device differs significantly from the above-mentioned US 5,394,882, for example in this refinement, in which only an opening is provided in the metallization, but this opening itself does not function as an antenna, but It is only used as an entry window or release window for high-frequency waves.

A slot antenna can be understood as an interruption in a metal structure, in this case a metal housing, via which electromagnetic waves can be radiated under suitable excitation conditions. For example, the slot antenna may have a dipole or semi-dipole structure. However, more complex geometries are in principle possible. As a part of the communication equipment, the antenna is generally implemented through a metal structure in the air or on a carrier substrate, and usually in a metal screen (such as a metal case here), electromagnetic waves neither enter nor exit due to its role as a Faraday cage. In principle, however, electromagnetic waves are radiated and/or received when fractures are caused in the case of dielectric and/or magnetic fields in otherwise homogeneous structures, for example in this case the structure of a metal housing. This is used in the case of slot antennas which operate according to the Babinet principle by perforating the metallic structure through one or more slots of suitable length and/or suitable geometry. As mentioned above, an opening in a metal structure (in this case in a metal housing) is defined as a slot, which opening has a high aspect ratio, ie a high ratio of length to width.

Slot antennas such as are used within the scope of the present invention for medical devices and in particular sensor devices are known in principle from the prior art. Slot antennas are therefore often used as antennas in the aircraft industry. Radiation from hollow conductors with slot structures is described, for example, in EP 1 263 086 A2. Slot antennas offer many significant advantages for existing applications and are ideally suited to solve the above-mentioned tasks and technical difficulties of known devices. On the one hand, the metal housing, which shields the sensitive semiconductor components from the sterilizing radiation, can therefore remain. In this way, for example, functional elements, in particular sensor elements, and actuating devices can be connected or connected to one another in a fixed manner and subsequently sterilized, which offers considerable advantages in terms of production technology. Nevertheless, radiation damage to the semiconductor components is avoided. Furthermore, it is also possible to dispense with a plug connection between the functional element—in particular the sensor element—and the actuating device, which, as mentioned above, offers structural advantages and thus significantly improves the signal quality. For example, a gas-tight sealing of the actuation device can thereby be achieved. The slot geometry of the slot antenna can be selected such that either ionizing radiation cannot penetrate the interior of the metal housing, or the slot geometry and the position of the slot can be selected such that no sensitive semiconductor components are located below the slot antenna in the interior of the metal housing , wherein the ionizing radiation of the sterilizing radiation can pass through the slot antenna to reach the sensitive semiconductor components. A slot antenna can in turn comprise one or more slots which are open and/or can be filled with air or another gas, but which can preferably also be sealed, for example with a dielectric material. For example, the dielectric material may exist as a solid. In particular, the dielectric material may be or comprise at least one plastic material, such as epoxy and/or polyurethane. The dielectric material should have a dielectric constant number or permittivity ε _r preferably around 1, such as a dielectric of <5, especially <3, preferably <2 or even <1.5 coefficient. The slot is therefore only located in the metal housing and is thus an interruption of the otherwise homogeneous structure of the metal housing, wherein the filling of the slot with a dielectric material has no or only slight influence on the antenna properties of the slot antenna. Furthermore, a suitable choice of the aspect ratio substantially prevents ionizing radiation from penetrating the slot structure into the interior of the housing.

Slot antennas are also known in principle from other technical fields. Slot antennas are thus known, for example, recently from transponder technology. For example, WO2007/048589 A1 describes a transponder chip module for a transponder with a slot antenna. The transponder chip module has a transponder chip and contact points electrically connected to the transponder chip, which are arranged on mutually facing surfaces of the transponder chip module. Slot antennas are also known in principle from RFID technology as well as from packaging technology, in which, for example, existing metallizations—for example for moisture insulation in drug gas bubbles—or so-called smart bags are equipped with suitable slot structures, which The structure functions as an antenna. An example of a slot antenna structure suitable for RFID technology is described in WO 03/092116 A2. If an RFID chip is connected to such a slot antenna, a transponder results as described above. So-called smart packages equipped with such transponders can store and/or change data or also operate sensors, such as temperature sensors, humidity sensors, etc.

In particular, the communication device can comprise at least one excitation device, which is designed to excite a slot antenna for emitting electromagnetic waves. For an expansion of such an excitation device, reference can be made to the known slot antenna or also to the above-mentioned WO 2007/048589 A1. The excitation of the slot antenna can take place, for example, via a wired connection or also wirelessly. For example, an electromagnetic resonant circuit can be provided, which can be electrically conductive (for example via one, two or more conductors connecting the excitation device to the metal housing and/or gap structure) or also wirelessly, for example by means of an arrangement in the metal housing The primary transmitter excites the slot antenna to emit electromagnetic waves. In particular, the excitation device can also have at least one inductive element for reducing the slot length of the slot of the slot antenna to a length of not more than 10 cm. The inductive element can comprise, for example, a coil or another type of inductive element in the excitation device and/or in the connection between the oscillator of the excitation device and the slot antenna. In particular, the slot structure can have slots with a slot length of no more than 10 cm, preferably no more than 5 cm and particularly preferably no more than 1 cm, preferably even less than 1 cm. If a slot antenna is used, it can, as mentioned above, in principle have any desired geometry. For example, linear geometries, especially bipolar and/or semi-bipolar geometries may be used. Other geometries are also possible in principle, for example bifurcated geometries. For example, fractal geometries can also be used. Such a fractal geometry can comprise a multiplicity of gaps, for example a multiplicity of branching gaps, which are arranged at an angle to one another and form, for example, a fractal pattern. Fractal geometries are known in principle from the field of printed, ie non-slotted antennas, for example from EP 1 326 302 A2. In principle, such fractal geometries can also be used within the scope of the invention for slot structures and in particular for slot antennas. As indicated above, the aperture structure may also be at least partially sealed with a dielectric material. This means that at least one gap can be completely or partially filled with a dielectric material which completely or partially seals the interior of the housing. In particular, the dielectric material can be selected such that it has a permittivity ε which (in its real and/or imaginary part) differs strongly from the permittivity of the material of the metal housing, For example at least 1.5 times, preferably at least 2 times and particularly preferably even at least 3 times. For example, the dielectric material may include at least one plastic material.

In particular, the metal housing can have a shielding effect against disinfecting radiation, in particular against ionizing radiation, as described above. Within the scope of the manufacturing method according to the invention for the manufacture of medical devices, in particular sensor devices, in particular radiation sterilization can be employed, in particular under conditions using ionizing particle radiation and/or ionizing electromagnetic radiation, for example from alpha (Alpha) radiation, beta (Beta) radiation, gamma (Gamma) radiation, X-ray radiation and electron radiation. Electron beam disinfection is therefore frequently used in medical technology as described above and also as possible within the scope of the present invention. Electron beams generally have beam energies between 3 MeV and 12 MeV, with typical disinfection doses at 25 kGy. Metal housings of medical devices, in particular sensor devices, can thus have a shielding effect which is at least 2 times, preferably at least 5 times and particularly preferably at least 10 times or even 20 times or 50 times greater for electron radiation between 3 and 12 MeV. For example, the radiation dose can be reduced in this way from an initial 25 kGy to a maximum of 12.5 kGy, preferably 5 kGy and particularly preferably a maximum of 2.5 kGy, a maximum of 1.25 kGy or even a maximum of 0.5 kGy. The latter takes into account the knowledge that, for example, conventional CMOS electronics typically do not suffer permanent damage or subsequent damage at radiation doses of 0.5 to 1 kGy. For example, the metal housing can have at least one metal selected from one of the following metals: aluminium; iron; lead; copper; noble metals, especially gold, silver, platinum; alloys. Combinations of the mentioned and/or other metals or elements are also conceivable. For example, the metal casing may have a thickness of at least 0.5 mm, preferably at least 1 mm or even at least 2 mm. As indicated above, the metal housing does not have to surround the entire control device, but should only shield the radiation-sensitive semiconductor components so that they are protected during radiation sterilization, preferably during directional, anisotropic radiation sterilization. For example, the metal housing can be formed as a half shell.

As shown above, the proposed slot structure does not interrupt the shielding effect only insignificantly. The slot structure can thus have, in particular, at least one slot which is geometrically formed and/or arranged in such a way that ionizing radiation passing through the slot into the housing during radiation sterilization does not hit the sensitive semiconductor components. Thus, for example, the slot structure can have at least one slot, and the actuating device can have at least one printed circuit board, which, for example, can be completely or partially rigid and/or flexible, wherein the electronic components, in particular at least one electronic semiconductor component, preferably all electronic components The semiconductor components are arranged on the circuit board outside the vertical projection of the slot on the circuit board.

In general, for example, the slot structure can have at least one slot, wherein the edges of the slot can span the plane. The stretching can take place, for example, in that the plane is defined such that all points of the edge lie on this plane or the sum of the squares of the distances between all points of the edge and the plane is minimized. In other words, the edges of the slot itself can be formed flat or also curved. The actuation device can have at least one carrier element, wherein the electronics are arranged on the carrier element outside the projection of the slot, wherein the projection is a projection perpendicular to the plane on the carrier element.

The carrier element does not have to be designed flat. The carrier element can thus comprise, for example, at least one planar circuit carrier, for example at least one circuit board. Alternatively or additionally, however, uneven circuit carriers can also be used, for example so-called three-dimensional circuit boards. Uneven circuit carriers can be producible, for example, by means of injection molding methods and/or by means of so-called molded interconnect device (Molded Interconnect Device, MID) technology. The carrier element can be designed completely or partially differently from the housing. Thus, for example, the carrier element can be completely or partially introduced into the housing as a separate component. Alternatively or additionally, however, the carrier element can also be completely or partially connected to the housing or even formed in one piece with the housing or a part of the housing. In particular, the at least one electronic component can also be applied completely or partially directly on the housing.

Preferably, the medical device and in particular the sensor device are even designed such that no electronics are arranged in the housing within an angle of incidence of ±5°, in particular ±10° and particularly preferably ±20°. Thus, for example, the slot structure can generally have at least one slot, wherein the edges of the slot stretch the plane in the sense defined above, wherein the electronic components are arranged outside the area formed as the sum of the cones, wherein the apex of the cone is Points on the edge of the gap where the cone axis is perpendicular to the plane and where the cone has a deviation of 10° (corresponding to a deviation of ±5° from the vertical projection), especially 20° (corresponding to a deviation of ±5° from the vertical projection 10° deviation) and particularly preferably an opening angle of 40° (corresponding to a deviation of ±20° from the vertical projection).

This means that no radiation-sensitive semiconductor components should be arranged below the gap in the actuation device. In addition, the ionizing radiation during radiation disinfection can also be directed such that it (if this is the case) enters the housing in an area in which no sensitive electronic components are arranged, in particular It is because no semiconductor device is arranged. Furthermore, the slot structure can have at least one metal shielding element protruding into the interior of the metal housing. The shielding element can, for example, comprise a flange protruding into the interior of the metal housing. The shielding bead or the shielding element can cause the ionizing radiation to enter through the opening of the slot structure, but then hit the shielding element and be absorbed there or be deflected in a direction in which no sensitive semiconductor components are arranged. superior. Alternatively or additionally, at least one shielding element or at least one shielding flange can also be formed as a radiation collector and/or include a radiation collector.

As indicated above, the housing can in particular be designed to be moisture-tight. This can be done, for example, by means of corresponding sealing elements and/or corresponding encapsulation. For example as described above, the metal housing can be coupled gas-tight to a carrier element, in particular a circuit carrier and particularly preferably a circuit board, wherein the carrier element carries the electronics. For example, a metal housing can be placed on the carrier element as a metal shell and can be cast, for example, together with the carrier element or sealed in another way, for example by gluing. The functional element, in particular the sensor element, is preferably connectable or connectable to the actuation device in a fixed manner. For example, at least one lead of a functional element, in particular a sensor element, can be guided into the housing via at least one sealing element and can be connected or connected there to the actuation device. The at least one sealing element may for example comprise a sealing lip and/or another type of elastomeric sealing and/or adhesive means. The actuating device can be completely or partially formed separately from the functional element, in particular the sensor element, but can also be completely or partially connectable or connectable to the functional element, in particular the sensor element, or integrally with the functional element, in particular the sensor element constitute. For example, at least one substrate of the functional element, in particular of the sensor element, can also simultaneously serve as the substrate of the actuation device. Thus, for example, flexible printed circuit boards or flexible lines can be used, which can form functional elements, in particular sensor elements or at least a part thereof, and at the same time form the actuating device or a part of the actuating device, for example the substrate of the actuating device. The flexible line or the flexible circuit board can be provided, for example, with at least one protective layer outside the housing, for example at least one protective varnish, wherein the protective layer can be configured separately from the optional sealing element and from the housing, wherein it is also possible A preferably seamless transition is provided between the protective layer and the housing, for example in that the functional element, in particular the sensor element, and/or its protective layer transitions directly and without cutout edges into the sealing element and/or the housing.

In a further aspect of the invention, a method for producing a medical device, in particular a sensor device, is proposed. In particular, this can be a medical device and particularly preferably a sensor device according to one or more of the developments described above or below. Reference is therefore made to the above description with regard to possible refinements of the medical device, in particular of the sensor device. In principle, however, other configurations of the medical device and in particular of the sensor device are also possible.

In the proposed method, at least one implantable functional element, in particular at least one implantable sensor element, and at least one actuation device with at least one electronics are provided. This can be done, for example, under sterile conditions, for example in a sterile room. Mounting, however, can preferably take place outside the sterilization chamber. The fact that a functional element, in particular a sensor element, can be connected to the actuation device also implies the possibility that the connection of the functional element, in particular a sensor element, to the actuation device is part of the method according to the invention. This method step of connecting the functional element, in particular the sensor element, to the actuation device can preferably also be carried out completely or partially under sterile conditions. The connection can be made, for example, by connecting two or more electrode leads for the electrodes of the functional element, in particular the sensor element, to corresponding components of the actuating device, such as a potentiostat and/or a primary amplifier. The actuation device is completely or partially shielded by a housing with at least one metal housing. This can be done, for example, in that the housing and/or metal housing is placed on one or more components of the operating device and/or is applied to a carrier element of the operating device after the functional element, in particular the sensor element, has been connected to the operating device. , wherein the control device is completely or partially surrounded. In principle, however, other configurations are also possible. Optionally, additional sealing can then take place. The shielding of the actuating device by the housing can be performed under sterile conditions. In this case, shielding is to be understood as an at least largely moisture-tight insulation of one or more components of the operating device, in particular at least one electronic component. In addition, as described above, an at least partial shielding against ionizing radiation, in particular electron radiation and/or beta radiation, takes place by the metal housing.

The operating device has at least one wireless communication device. The metal housing has at least one slot structure, wherein the communication device is designed to communicate with at least one external device through the slot structure. In particular, this can be done by introducing at least one slot, in particular at least one slot antenna, into the metal housing before or after producing the shield. If a slot antenna is provided, a suitable coupling of the communication device to the slot antenna is preferably provided, for example via a corresponding conductive or wireless connection between an excitation device of the communication device and the slot antenna.

Radiation disinfection by ionizing radiation may generally include radiation disinfection using electromagnetic radiation and/or particulate radiation. For this purpose, for example alpha radiation, beta radiation, gamma radiation, X radiation or electron beams can be used, wherein no distinction is made below between electron beams and beta radiation. Combinations of the described beam types can also be used. The use of ionizing radiation has the advantage that in particular the sensitive electrodes of the sensor elements are not or only insignificantly affected by chemical influences. Radiation disinfection with ionizing radiation can in particular be carried out using anisotropic ionizing radiation, for example by directing the ionizing radiation onto the medical device, in particular the sensor device. Preferably, the direction of incidence is selected such that, during the incidence, the metal housing is arranged between the radiation source and at least one electronic component, in particular at least one radiation-sensitive semiconductor component. This can be done, for example, using a metal housing in the form of a shell or half-shell in such a way that the shell or half-shell spans at least one electronic component in a dome-like manner and is shielded from radiation, whereas for example a medical device, in particular a sensor device Other areas are accessible for radiation. In particular, the production of components or medical devices and in particular sensor devices can take place under non-sterile conditions, for example outside a sterile room. Radiation sterilization can then take place, for example, in a state in which the medical device, in particular the sensor device, has been encapsulated, for example by means of bubble wrap. Thus, for example, the medical device, in particular the sensor device, can first be produced non-sterile, then packaged, for example, in a bubble wrap or other antibacterial packaging, and then sterilized in such a way that the sterilizing radiation penetrates the packaging. In particular, the direction of incidence of the ionizing radiation on the housing can be selected such that the ionizing radiation entering the housing through the slot structure does not reach at least one electronic component or at least sensitive electronic components of the actuation device, for example sensitive semiconductor components. In this case, the direction of incidence is to be understood in particular as the spatial direction from which the ionizing radiation impinges on the housing.

In summary, the following embodiments are considered particularly preferred within the scope of the present invention:

Embodiment 1: A medical device for performing at least one medical function on a human or animal body, in particular a sensor device for monitoring at least one individual function, in particular for identifying at least one analyte in a body fluid, wherein the medical device Comprising at least one implantable functional element, in particular at least one implantable sensor element, and at least one operating device with at least one electronic component, wherein the functional element can be connected to the operating device, wherein the operating device has at least one A housing of a metal housing, wherein the operating device has at least one wireless communication device, wherein the metal housing has at least one slot structure, wherein the communication device is designed to communicate with at least one external device via the slot structure.

Embodiment 2: The medical device according to the preceding embodiment, wherein the actuation device is at least partially arranged in the metal housing.

Embodiment 3: The medical device according to one of the preceding embodiments, wherein the medical device comprises a sensor device, in particular a sensor device for monitoring at least one body function and/or a sensor device for identifying at least one analyte in a body fluid , and wherein the functional element comprises at least one implantable sensor element, in particular at least one implantable sensor element for identifying at least one analyte in a bodily fluid.

Embodiment 4: Medical device for performing at least one medical function on the human or animal body, especially for monitoring at least one body function, especially for identifying at least one analysis in bodily fluids, especially according to one of the preceding embodiments A sensor device for an object, wherein the medical device comprises at least one implantable functional element, in particular at least one implantable sensor element, wherein the medical device further comprises at least one control device with at least one electronic device, wherein the functional element can communicate with An actuation device connection, wherein the actuation device has a housing with at least one metal housing, wherein the metal housing is produced entirely from a metal material, wherein the actuation device is at least partially arranged in the metal housing, wherein the metal housing completely or partially surrounds the actuation device, wherein The operating device has at least one wireless communication device, wherein the wireless communication device comprises a device for communication selected from the group consisting of radio communication, communication via inductive coupling and communication via galvanic coupling, wherein the metal housing has at least one slot structure , wherein the communication device is designed to communicate with at least one external device via the slot structure, such that the communication takes place via the slot structure.

Embodiment 5: The medical device according to the preceding embodiment, wherein the medical device comprises a sensor device, in particular a sensor device for monitoring at least one individual function and/or a sensor device for identifying at least one analyte in a bodily fluid, and Wherein the functional element comprises at least one implantable sensor element, in particular at least one implantable sensor element for identifying at least one analyte in a bodily fluid.

Embodiment 6: The medical device according to one of the preceding embodiments, wherein the functional element, in particular the sensor element, comprises at least one electrochemical sensor having at least two sensor electrodes arranged in the body tissue in the implanted state of the functional element, In this case, the actuating device has at least one potentiostat and/or at least one primary amplifier connected to the sensor electrodes, wherein the potentiostat and/or primary amplifier are arranged in the metal housing.

Embodiment 7: The medical device according to one of the preceding embodiments, wherein the metal housing forms a metal shell shielding the manipulation device in at least one direction.

Embodiment 8: The medical device according to one of the preceding embodiments, wherein the metal housing is hermetically coupled to a carrier element, in particular a circuit board, wherein the carrier element carries the electronics.

Embodiment 9: The medical device according to one of the preceding embodiments, wherein the slot structure comprises at least one slot antenna.

Embodiment 10: The medical device according to the preceding embodiment, wherein the communication device comprises at least one excitation device, wherein the excitation device is designed to excite a slot antenna for emitting electromagnetic waves.

Embodiment 11: The medical device according to one of the preceding embodiments, wherein the gap structure is at least partially sealed with at least one dielectric material.

Embodiment 12: The medical device according to one of the preceding embodiments, wherein the metal housing has at least a 2-fold, preferably at least 5-fold and particularly preferably at least 10-fold shielding effect against electron radiation between 3 and 12 MeV.

Embodiment 13: The medical device according to one of the preceding embodiments, wherein the metal housing has at least one metal selected from one of the following metals: aluminum; iron; lead; copper; noble metals; alloys.

Embodiment 14: The medical device according to one of the preceding embodiments, wherein the slot structure has at least one slot, wherein the edges of the slot stretch a plane, wherein the actuation device has at least one carrier element, wherein the electronic component is arranged on the carrier element at the edge of the slot. projection, wherein the projection is a projection onto the carrier element perpendicular to the plane.

Embodiment 15: The medical device according to the preceding embodiment, wherein the carrier element is a circuit board.

Embodiment 16: The medical device according to one of the preceding embodiments, wherein the slot structure has at least one metal shielding element, in particular a shielding flange, protruding into the interior of the metal housing.

Embodiment 17: The medical device according to one of the preceding embodiments, wherein the functional element, in particular the sensor element, is fixedly connected to the actuation device, wherein at least one lead of the functional element is guided into the housing via at least one sealing element.

Embodiment 16: Method for producing a medical device, in particular a sensor device, in particular a medical device according to one of the preceding embodiments, wherein at least one implantable functional element, in particular at least one implantable sensor element, is provided , and at least one operating device with at least one electronic component, wherein the functional element can be connected to the operating device, wherein the operating device is shielded by a housing having at least one metal housing, wherein the operating device has at least one wireless communication device, wherein the metal housing has At least one slot structure, wherein the communication device is designed to communicate with at least one external device via the slot structure, wherein the medical device is sterilized with at least one ionizing radiation.

Embodiment 17: Method for producing a sensor device, in particular a sensor device according to one of the aforementioned embodiments relating to a sensor device, wherein at least one implantable sensor element and at least one actuation device having at least one electronic component are provided, wherein the sensor element can be connected to an actuating device, wherein the actuating device is shielded by a housing having at least one metal housing, wherein the metal housing is completely manufactured from a metallic material, wherein the actuating device is at least partially arranged in the metal housing, wherein the metal housing is fully or partially Surrounding the control device, wherein the control device has at least one wireless communication device, wherein the wireless communication device includes a device for communication selected from the group consisting of radio communication, communication via inductive coupling and communication via electrical coupling, wherein the metal The housing has at least one slot structure, wherein the communication device is designed to communicate with at least one external device via the slot structure, so that the communication takes place via the slot structure, wherein the sensor device is sterilized with at least one ionizing radiation.

Embodiment 18: The method according to one of the two preceding embodiments, wherein anisotropic ionizing radiation is used, in particular beta radiation, wherein the direction of incidence of the ionizing radiation on the housing is chosen such that it enters the housing through the slot structure The ionizing radiation does not reach the electronics.

The above-proposed medical device, in particular a sensor device, and the method for producing a medical device, in particular a sensor device, have numerous advantages over known medical devices and production methods. Contrary to the prior art which does not or only insufficiently solves the aforementioned contradictory technical objectives, according to the proposed invention an optimum sealing and shielding can be ensured, while at the same time it is possible to communicate between the operating device and at least one external device via a communication device, preferably Wireless communication is provided by means of slot antennas. At the same time, the possibility of using a metal housing also offers considerable advantages in terms of the tightness of the housing compared to conventional housings which are generally produced entirely from plastic. Plastics generally have a comparatively high moisture vapor permeability due to their molecular structure, whereby water and water vapor penetrate into the plastic housing after a relatively short time (generally within hours to days) in the usual case of plastic housings, and Undesirable parasitic leakage currents in the actuating device can generally result there. According to the prior art, therefore, high costs are required for optimizing the compaction, for example in the form of multilayer structures or desiccant chambers embedded therebetween. Furthermore, plastic injection molding methods are usually applied. However, wall thicknesses of less than 1 mm can generally be restrained only with difficulty. However, conventional housings corresponding to the prior art and in particular multi-layered are therefore generally relatively thick-walled and thus large. This is all the more decisive since the implanted or partially implanted system should be designed to be as small and light as possible due to the measured carrying comfort.

The inventive possibility of using a metal housing eliminates these disadvantages in a simple and ingenious manner. Metals have the advantage of being significantly less permeable and at the same time able to attenuate the disinfecting radiation. In this way, the actuating device, in particular the potentiostat and/or the primary amplifier, can be insulated from the environment in a gas-tight manner due to the processing of relatively small signals and the high insulation requirements, and nevertheless be arranged in the vicinity of the functional element , especially near the sensor element. However, since the metal housing provides shielding from ionizing radiation, functional elements, in particular sensor elements, can at the same time be sterilized by radiation, since the electronics of the actuating device are protected by the metal housing. The system interface can thus be omitted. This eliminates the above-mentioned disadvantages of actuating the interface by the user and the associated disadvantages of a reliable seal. In particular, the above-mentioned sealing problems can be reliably avoided by a fixed connection between the functional element, in particular the sensor element, and the actuating device (eg potentiostat). However, through the use of slot structures, in particular slot antennas, it is possible at the same time to maintain the communication between the operating devices emanating from the metal housing. The metal housing can completely or also only partially surround the actuation device, wherein communication with at least one external device is still possible via at least one slot structure.

Overall, therefore, different advantages can be combined with the solution according to the invention. On the one hand, a small penetration of the metal can thus be used, which in particular improves the insulation of the actuation device. As a result, the signal quality can be increased and the risk of false signals can be significantly reduced. At the same time, the metal housing as a "metal cage" guarantees good shielding during radiation sterilization, in particular by means of beta radiation. In particular, a slot structure in the form of one or more slot antennas enables radio from almost completely closed metal housings. These advantages enable new product categories and in particular miniaturized medical devices and particularly preferably miniaturized sensor devices since, for example, critical interfaces between functional elements, especially sensor elements, and the reusable part can be dispensed with. It is even possible to manufacture medical devices, in particular sensor devices, which can be designed as total implants, that is to say medical devices in which functional elements, in particular sensor elements, and the actuation means connected thereto can be completely implanted in the body tissue of the user And especially sensor devices. The full implant may include chemically reactive electrodes. Full implants can be sterilized without risk of radiation damage.

Description of drawings

Further details and features of the invention emerge from the following description of preferred embodiments, especially in conjunction with the subclaims. In this case, the corresponding features can be realized individually or in combination with one another. The present invention is not limited to the examples. Embodiments are shown schematically in the figures. The same reference numbers in the various figures designate elements that are identical or functionally identical or that correspond to one another in terms of their function.

In detail:

FIG. 1 shows a first embodiment of a sensor device according to the invention with a sensor element and an actuating device detachable via a plug connector;

Figures 2A and 2B show an embodiment of a sensor device with permanently connected sensor elements and manipulation means;

3A and 3B illustrate an embodiment of a fully implanted sensor device with an external reading device; and

FIG. 4 shows an embodiment of a sensor device with a flexible circuit board as sensor carrier.

Detailed ways

A first exemplary embodiment of a sensor device 110 according to the invention for monitoring at least one individual function, here in particular for identifying at least one analyte in a bodily fluid, is schematically shown in FIG. 1 . The sensor device 110 is used as an embodiment of a medical device 111 for performing at least one medical function on the human or animal body.

The sensor device 110 firstly corresponds largely in construction to the sensor device described in EP 1 972 269 A1 and comprises a disposable part 112 , ie a disposable part, and a reusable part 114 , ie a reusable part. The disposable 112 includes a sensor element 116 in the illustrated embodiment. The sensor element 116 is generally an embodiment of an implantable functional element 117 . The sensor element 116 may, for example, comprise a flexible carrier 118, such as a foil carrier, and two, three or more electrodes 120 for electrochemical analyte identification. Furthermore, the disposable 112 comprises an electronic component 122 with an energy supply, for example in the form of a battery 124 , and a memory element 126 , for example in the form of an EEPROM. Storage element 126 may contain, for example, batch-specific data for sensor element 116 .

In the exemplary embodiment shown, the disposable part 112 is connected to the reusable part 114 via a plug connector 128 . The plug connector 128 , like optionally also one or more other plug connectors of the sensor device 110 , can comprise at least one sealing element 129 , which can be the plug connector 128 and/or the housing 142 Component parts of the components and/or other components or the sealing element 129 can be designed completely or partially as separate components. The reusable part 114 may include, inter alia, a device denoted "AFE" (analog front end) in FIG. 1 and may include, for example, a potentiostat 130 and/or a primary amplifier 132 with a high input resistance. Furthermore, the reusable part 114 can comprise a data processing device 134 , which can be designed, for example, for measurement data analysis or at least temporarily for measurement data analysis. The data processing device 134 is represented in FIG. 1 as a microcontroller (μC). The data processing device 134 can have its own memory or alternatively or additionally can use the memory element 126 of the disposable 112 .

Additionally, the reusable piece 114 includes a communication device 136 in the illustrated embodiment. In the exemplary embodiment shown, this communication device is designed as a high-frequency (RF) communication device 136 , for example as a radio chip.

According to the structure described so far, according to the embodiment of FIG. 1 , there is a separation between the reusable part 114 and the disposable part 112 . Disposable part 112 may, for example, comprise, in addition to sensor element 116 , a base plate 138 or another type of carrier element which contains battery 124 and memory element 126 , for example a memory chip. This base plate 138 with the storage element 126 and the battery together with the reusable part 114 form the operating device 140 of the sensor device 110 . This example shows that actuating device 140 can also be designed in multiple parts. For the mode of operation of the sensor device 110 according to FIG. 1 , reference may be made largely to EP 1 972 269 A1. Disposables 112 are typically only used within a daily cycle, such as for one week. The reusable piece 114 together with the disposable piece 112 presents a workable patch of the sensor device 110 . The reusable member 114 is preferably designed for multiple uses, such as for more than 50 cycles and/or for one year's use.

In order to avoid current delays through the actual measuring system 130, 132, for example through an AFE, in the case of the sensor device 110 according to FIG. All electrical components other than body tissue such as the interstitium in contact and generating the measurement signal) are completely galvanically insulated from the environment. Furthermore, especially in the reusable part 114 , it is to be avoided that leakage currents flow between measuring current-carrying and/or potential-carrying components. Therefore, the insulation resistance throughout the circuit must generally be relatively high, for example above 10 ¹² ohms or even above 10 ¹³ ohms. To this end, it can be avoided that moisture can reach these components through ambient humidity (eg water vapor to liquid water) and form a conductive electrolyte there, possibly together with impurities (eg ions). For this purpose, in the present invention the electronic modules of the disposable part 112 and the reusable part 114 , that is to say the operating device 140 are accommodated in a housing 142 . These housings 142 are designed, for example, completely or partially as metal housings 144 . For example, metal housing 144 may be provided in the form of a metal cup. These metal cups can be produced, for example, by conventional metal processing methods such as stamping and/or deep drawing. Electronic components 126 , 130 , 132 , 134 and 136 or parts of these electronic components may be applied on one or more carrier elements 146 , for example one or more circuit boards. The assembled circuit board can be introduced into the metal housing 144 . Furthermore, a sealing can be performed, for example by casting and/or gluing.

Sensor device 110 produced in this way according to FIG. 1 can then generally be sterilized by radiation. For example, beta radiation is commonly used in radiation sterilization. In this context, the range of action of the beta radiation in the metal housing is generally of interest for the shielding effect of the metal housing 144 . First of all, the range of action depends on the density of the material. Typically, for example, beta radiation between 3 MeV and 12 MeV is used, with a typical radiation dose of 25 kGy being used. Beta radiation with an intensity of 10 MeV penetrates, for example, approximately 6 mm in iron and approximately 19 mm in the case of aluminum. Therefore, iron may be preferable as a material for the metal case 144 . Copper is also very effective, and copper also absorbs the secondary radiation (X-rays—bremsstrahlung) that occurs during beta radiation. A 3mm thick copper screen is sufficient to sufficiently attenuate the radiation at 25kGy. In general, aluminum and copper form a good compromise as materials with regard to screen action, handling and weight. In principle, however, other materials and composites of different materials can also be used. Thus, for example, the aluminum layer has the function of attenuating beta radiation, whereas a second layer of heavy metal (eg lead) brings about the attenuation of bremsstrahlung. Furthermore, a thin sheath made of a suitable polymer can be provided which provides a biocompatibility function, since heavy metals are generally not biocompatible. These examples demonstrate that metal housing 144 need not consist of only one material. In general, therefore, for example, metal housings of various materials and metal housings constructed in multiple layers can also be used. Metallic materials and non-metallic materials can also be combined here.

The exemplary embodiment of sensor device 110 shown in FIG. 1 is a so-called continuous monitoring sensor. In principle, however, analyte sensors or biophysical sensors as well as actuators and combinations of such devices can also be derived using the invention.

In the case of the exemplary embodiment shown in FIG. 1 , the reusable part 114 and the disposable part 112 are connected to each other via plug connectors 128 (eg plug contacts), as indicated above. The plug connector 128 is guided through the metal housing 144 here, preferably by means of a plastic sleeve. The surface of the penetration device is preferably designed to be small compared to the entire surface of the metal cup or metal housing 144 . The plug-in area is likewise hermetically sealed, for example by means of a detachable seal, in particular by means of an O-ring. In this case, in particular, customary connector systems such as Poco contacts or blade contacts can be used. Other configurations are also possible.

The above-mentioned problem arises when the metal housing 144 is used, namely that the metal housing 144 acts as a Faraday cage and basically does not transmit the signals of the communication device 136 . In the exemplary embodiment shown, therefore, a slot structure 148 is introduced on the side of the metal housing 144 , eg metal cup, reusable part 114 facing away from the body, ie in the desired radiation direction of the radio signal. In the illustrated exemplary embodiment, the slot structure 148 functions in particular as a slot antenna 150 with a slightly elongated slot 152 , which is shown as an angled slot in the illustrated exemplary embodiment. In principle, however, other slot geometries are also possible. Slot antenna 150 is supplied with a high-frequency signal via excitation device 154 of communication device 136 , not shown in more detail in FIG. 1 , and is excited for the emission of radio waves outside metal housing 144 . The plan view according to FIG. 1 shows that slot antenna 150 or slot 152 is preferably arranged such that it is not located above sensitive electronic components, for example components 130 , 132 , 134 , 136 . In this way, the probability of damage to these components by radiation entering through the gap 152 during radiation sterilization is reduced. In principle, however, other positions of the slot antenna 148 are also possible, for example a position closer to the body. However, these locations are generally not optimal with respect to their radiation and/or reception characteristics. In order to obtain the best possible reception and/or radiation properties, different slot structures 148 are also possible. The geometry and expansion of the slot structures 148 can be optimized so that, for example, spirals, meanders or the like can be used. Furthermore, the dimensions of the antenna structure can be adapted to the frequency and/or wavelength used by means of a suitable slot structure. In particular, antenna shortening is possible in this way. For this purpose, excitation device 154 and/or slot structure 148 itself can comprise, for example, one or more inductances. Due to the requirement for the miniaturization of such systems, high frequencies are generally better suited than low frequencies due to the shorter wavelength. At the prevailing ISM frequency of 2.4 GHz, which is freely available worldwide, slot structures with a length of several centimeters are produced. These gap structures can also be further shortened by suitable inductance. In principle, however, other wavelengths are also possible.

The slots 152 of the slot structure 148 can also be filled with an insulating and/or sealing compound. For example, in this case it may be a polymer material with a substantially different dielectric constant than the metal of the metal housing 144 . As a result, the small penetration of the entire housing does not or only insignificantly affect it, since this penetration is in particular a surface function.

Since the sensor device 110 shown in FIG. 1 can now also be sterilized without covering, a second embodiment of the sensor device 110 is shown in FIGS. 2A and 2B as an example of a medical device 111 in which the plug connection has been omitted. The division of the device 128 and the sensor device 110 into the disposable 112 and the reusable 114. In this exemplary embodiment, sensor element 116 , which is an example of functional element 117 , is firmly connected and integrated with actuation device 140 and there, in particular, with AFE 130 , 132 . In this case it is also possible to miniaturize and/or combine a plurality of electronic components of the control device 140, for example by combining several or all of the illustrated components into a common integrated circuit and and/or integrated semiconductor devices such as ASICs (Application Specific Integrated Circuits). In this way, for example, an economical improvement of the integrated sensor device 110 can be contributed, although there are no longer reusable components of the sensor device 114 . It is also possible, for example, to extend the service life of the sensor in the interstitium by more than a week, and the electronics of the control device 140 can be designed very cost-effective overall.

FIG. 2B shows a sectional view of sensor device 110 according to FIG. 2A from the side. Also shown symbolically here is body tissue 156 into which sensor element 116 is partially implanted with its electrode 120 side. It can be seen here that the metal housing 144 is in the exemplary embodiment shown a half-shell which is placed over a carrier element 146 carrying all or at least several electronic components 130 to 136 . Thus, for example, the half shell is arranged relative to communication device 136 precisely in such a way that it is arranged in the direction of possible radiation of communication signals for radio communication. The half-shell can then be closed gas-tight to the body tissue 156 by means of one or more seals, for example by gluing and/or casting, so that the carrier element 146 with the electronics can be arranged inside the gas-tight shielding housing 142 . The carrier 118 of the sensor element 116 with the corresponding leads accommodated thereon can then be introduced into the interior of the housing 142 via one or more sealing elements 160 , which are not shown in more detail in FIG. 2B .

Furthermore, it can be seen again in FIG. 2B that the slot structure 148 is arranged remote from the electronic components 130 to 136 . Radiation disinfection 162 is shown symbolically in FIG. 2B , but of course the radiation disinfection does not take place at the sensor device 110 applied to the body tissue 156 , but already takes place during manufacture and before use by the user. In particular, the radiation disinfection 162 can be carried out anisotropically, with a direction of incidence inclined relative to the normal of the carrier element 146 . Even in this case the radiation of radiation disinfection 162 should penetrate the interior of housing 142 so that it does not strike the electronic printed circuit board formed by carrier element 146 and electronic components (for example 130 to 136 ). In this way, radiation damage can be avoided. Furthermore, one or more shielding elements 164 can be arranged in the region of the gap 152 , for example by bending the metal shell 144 inwards in this region and forming a collar. In this way, radiation entering through the opening of slot 152 can also be absorbed in the interior of housing 142 and/or deflected in a harmless direction.

In the case of the exemplary embodiment of sensor device 110 shown in FIGS. 2A and 2B , carrier 118 and carrier element 146 of sensor element 116 are designed as separate elements by way of example. But this is not necessarily the case. Thus, in the exemplary embodiment shown in FIGS. 2A and 2B , at least one carrier 118 of the sensor element 116 can be connected to at least one carrier element of the actuating device 140 as optionally also in other embodiments of the sensor device 110 according to the invention. 146 fully or partially bonded. For example, the carrier 118, which can also be referred to as a sensor substrate, can also form a rigid or flexible circuit board as the operating device 140 or as a carrier element 146 of a part of the operating device 140, wherein a plurality of such sensor substrates can also be provided (eg in layer structure). An example of such an arrangement is shown in FIG. 4 . This embodiment can basically correspond to the embodiment according to FIGS. 2A and 2B , so that for the description of the individual elements reference can be made to the above description. However, other configurations are also possible. In this exemplary embodiment, the carrier 118 of the sensor element 116 comprises a flexible circuit board, for example a flexible conductor 184 , which is also guided into the housing 142 and serves there as the carrier element 146 of the actuating device 140 . Flexible line 184 can comprise, for example, one or more conductor tracks 186 on one or both sides, which can be connected to electrodes 120 of sensor element 116 and can connect said electrodes 120 to actuation device 140 . The flexible line 184 can, for example, be coated in the region of the sensor element 116 with one or more layers covering the element 188 , for example a protective varnish 190 , preferably in such a way that the electrodes 120 remain exposed. The protective varnish 190 or the covering element 188 can optionally also form the sealing element 129 or a part thereof at the transition to the housing 142 . In particular, the covering element 188 can transition directly and without a cutout edge into the sealing element 129 . The cover element 188 can completely or partially cover the sensor element 116 and optionally also the housing 142 completely or partially, for example by covering the housing 142 and in particular the metal housing 144 completely or partially with a protective varnish 190 . In this way, the cover element 188 can optionally also be a component part of the housing 142 in this embodiment or also in other embodiments and, for example, provide corrosion protection for the metal housing 144 . Furthermore, in this exemplary embodiment or also in other exemplary embodiments, the inner space 192 of the housing 142 can be left free or also be completely or partially filled with a filler 194 , for example a dielectric filler 194 .

Through the aforementioned miniaturization and integration, it is also possible to realize a fully integrated medical device 111 , in particular a fully integrated sensor device 110 , which can also be designed as a full implant, for example. This is shown by way of example in FIG. 3A , while FIG. 3B shows a section of the metal housing 144 of the sensor device according to FIG. 3A in the region of the slot structure 148 in a plan view. In this case, the sensor device 110 is a full implant that can be completely implanted in the body tissue 156 . In this case, the sensor device 110 can in principle be designed similarly to the sensor device according to FIG. 2A , for example. In order to minimize the volume of the manipulation device 140 , which may be preferred in the case of a full implant 166 , it is also possible to transfer the functionality of the manipulation device 140 , in the exemplary embodiment to an external reading device 168 middle. Thus, for example, actuation device 140 of sensor device 110 can be reduced to only AFE 130 , 132 . As shown in FIG. 3A , it can also additionally have RFID functionality and thus already be part of communication device 136 . Similar to FIG. 2A , communication device 136 can again communicate with at least one external device (eg, reader 168 ) via slot antenna 150 . Alternatively, however, the possibility is shown in FIG. 3A in which the slot structure 148 is not used as a slot antenna 150 , but rather for the purpose of inductively exchanging data with the reading device 168 . For this purpose, a coil 170 can be placed in or in the vicinity of the slot structure 148, for example a coil 170 encased in metal, wherein the metal casing 144 can be passed through the coil 170 with other coils 172 in the reading device 168 The slot structure 148 inductively exchanges signals. Coil 170 can be formed, for example, in the form of a copper wire and can be embedded, for example, in a dielectric material or filler material 171 , for example a sealing polymer that can seal gap 152 . Coil 170 can be contacted, for example, via terminals 169 and/or feedthroughs and connected, for example, to communication device 136 . Metal housing 144 can be sterilized by radiation during manufacture, while electronics, especially AFE/RFID 130, 132 do not suffer from ray damage.

The data processing device 134 as well as the energy supply (for example the battery 124 ) can be transferred into the reading device 168 . The reading device 168 may also comprise an RFID reader 164 for inductively acquiring, for example, measurement signals of the AFE 130 , 132 via the coils 170 , 172 . Inductive coupling between the coils 170 , 172 can likewise be used according to known RFID technology for the permanent supply of energy and/or the transfer of data to the full implant 166 .

Furthermore, reading device 168 may also include a communication device 176 , for example with a radio-frequency transmitter 178 and an antenna 180 . The reader device 168 , which is not necessarily designed to be sterile, can have its own housing 182 , which does not have to be sterile because it is preferably arranged outside the body tissue. Therefore, the housing 182 can also be made of non-metallic material, so that instead of or in addition to the slot structure, a conventional antenna structure can also be used for the antenna 180 . Alternatively or additionally, however, it may also be advantageous to use the slot antenna again for far-field communication between the reader 168 and other devices, since the reader 168 may also have to meet biocompatibility requirements and can be sterilized. In this case, the housing 182 can again be designed completely or partially as a metal housing. Implantation of the antenna 180 for far-field communication under the skin, although also possible in principle, is poorly achievable in practice, since high frequencies are strongly absorbed in tissue and since long-wave frequencies are therefore required, the Long wave frequencies in turn lead to too high antenna dimensions. The division of the device shown in FIG. 3A into a reading device 168 and a full implant 166 is thus a good compromise, since near-field communication can take place inductively between the full implant 166 and the reading device 168, And conventional far-field communication may take place between the reading device 168 and other devices, such as one or more of the other devices described above.

List of reference signs

110 sensor equipment

111 Medical Equipment

112 Disposable pieces

114 reusable pieces

116 sensor elements

117 functional components

118 carriers

120 electrodes

122 electronic components

124 batteries

126 storage elements

128 socket connector

129 sealing elements

130 potentiostat

132 primary amplifier

134 Data processing equipment

136 communication equipment

138 bottom plate

140 control device

142 shell

144 metal case

146 carrier elements

148 gap structure

150 slot antenna

152 Gap

154 incentive equipment

156 Body tissue

158 seals

160 sealing element

162 radiation disinfection

164 shielding elements

166 full implants

168 reading device

169 terminals

170 coil

171 filling material

172 coils

174 RFID reader

176 Communication equipment

178 high frequency sensor

180 antennas, especially dipoles

182 shell

184 flexible wire

186 printed wires

188 cover elements

190 protective paint

192 internal space

194 packing

Claims (15)

1. A medical device (111) for performing at least one medical function on the human or animal body, in particular a sensor device (110) for monitoring at least one bodily function, wherein the medical device (111) comprises at least one implantable A functional element (117), in particular at least one implantable sensor element (116), wherein the medical device (111) also comprises at least one control device (140) with at least one electronic component (130, 132, 134, 136), wherein the functional element (117 ) can be connected with the control device (140), wherein the control device (140) has a housing (142) with at least one metal housing (144), wherein the metal housing (144) is completely made of metal material, wherein the control device (140) Arranged at least partially in a metal housing (144), wherein the metal housing (144) completely or partially surrounds the operating device (140), wherein the operating device (140) has at least one wireless communication device (176), wherein the wireless communication device ( 176) comprising means for communication selected from the group consisting of radio communication, communication via inductive coupling and communication via electrical coupling, wherein the metal housing (144) has at least one slot structure (148), wherein the communication means ( 176 ) is designed to communicate with at least one external device via the slot structure ( 148 ), such that the communication takes place by means of the slot structure ( 148 ). 2. The medical device (111) according to the preceding claim, wherein the medical device (111) comprises a sensor device (110), wherein the functional element (117) comprises at least one implantable sensor element (116). 3. The medical device (111) according to the preceding claim, wherein the sensor element (116) comprises at least one electrochemical sensor with at least two sensor electrodes ( 120), wherein the control device (140) has at least one potentiostat (130) and/or at least one primary amplifier (132) connected to the sensor electrode (120), wherein the potentiostat (130) and/or primary amplifier ( 132) arranged in a metal housing (144). 4. The medical device (111) according to one of the preceding claims, wherein the metal housing (144) forms a metal shell shielding the actuation device (140) in at least one direction. 5. The medical device (111) according to one of the preceding claims, wherein the metal housing (144) is hermetically coupled to a carrier element, in particular a circuit board, wherein the carrier element carries electronics (130, 132, 134, 136). 6. The medical device (111) according to one of the preceding claims, wherein the slot structure (148) comprises at least one slot antenna (150). 7. The medical device (111) according to the preceding claim, wherein the communication device (176) comprises at least one excitation device (154), wherein the excitation device (154) is designed to excite a slot antenna (150) for emitting electromagnetic waves. 8. The medical device (111) according to one of the preceding claims, wherein the gap structure (148) is at least partially sealed with at least one dielectric material. 9. The medical device (111) according to one of the preceding claims, wherein the metal housing (144) has a shielding effect of at least 2 times, preferably at least 5 times and particularly preferably at least 10 times, against electron radiation between 3 and 12 MeV . 10. The medical device (111) according to one of the preceding claims, wherein the metal casing (144) has at least one metal selected from one of the following metals: aluminium; iron; lead; copper; noble metals; alloys. 11 . The medical device ( 111 ) according to claim 1 , wherein the slot structure ( 148 ) has at least one slot ( 152 ), wherein the edges of the slot ( 152 ) stretch out a plane, wherein the actuation device ( 140 ) has at least one carrier Component (146), wherein the electronic components (130, 132, 134, 136) are arranged on the carrier element (146) outside the projection of the slot (152), wherein the projection is a projection on the carrier element (146) perpendicular to the plane. 12. The medical device (111) according to one of the preceding claims, wherein the slot structure (148) has at least one metal shielding element (164), in particular a shielding flange, protruding into the interior of the metal housing (144). 13. The medical device (111) according to one of the preceding claims, wherein the functional element (117), in particular the sensor element (116), is fixedly connected to the actuation device (140), wherein at least one lead of the functional element (117) is passed through At least one sealing element (160) is guided into the housing (142). 14. Method for producing a medical device (111), in particular a sensor device (110), in particular a medical device (111) according to one of the preceding claims, wherein at least one implantable functional element (117), In particular at least one implantable sensor element ( 116 ) and at least one control device ( 140 ) with at least one electronics ( 130 , 132 , 134 , 136 ), wherein the functional element ( 117 ) can be connected to the control device ( 140 ), wherein the control device ( 140 ) is shielded by a housing ( 142 ) having at least one metal housing ( 144 ), wherein the metal housing ( 144 ) is completely manufactured from a metal material, wherein the actuating device ( 140 ) is at least partially arranged in the metal housing ( 144 ), Wherein the metal casing (144) completely or partially encloses the control device (140), wherein the control device (140) has at least one wireless communication device (176), wherein the wireless communication device (176) includes a device for communicating by radio, via inductance A device for communication selected from the group consisting of coupled communication and communication via galvanic coupling, wherein the metal housing (144) has at least one slot structure (148), wherein the communication device (176) is designed, through the slot structure (148) Communication with at least one external device is performed such that the communication takes place via the slot structure (148), wherein the medical device (111) is at least partially sterilized with at least one ionizing radiation. 15. The method according to the preceding claim, wherein anisotropic ionizing radiation is used, in particular beta radiation, wherein the direction of incidence of the ionizing radiation onto the housing (142) is chosen such that it enters the housing through the slot structure (148) (142) The ionizing radiation does not reach the electronics (130,132,134,136).

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