HK1181687A - A method and a sterilizing device for sterilizing an implantable sensor - Google Patents

Description

Method and disinfection device for disinfecting an implantable sensor

Technical Field

The present invention relates to a method for sterilizing an implantable sensor and a sterilization device for sterilizing an implantable sensor. The sensor is for sensing at least one analyte in body tissue. The sensor may in particular be an electrochemical sensor configured for qualitatively and/or quantitatively sensing one or more analytes in the body tissue by electrochemical means. Such sensors are used, for example, in the monitoring of blood glucose concentrations. Other fields of use are also conceivable.

Background

The prior art discloses a number of sensors that can be implanted fully or partially in body tissue for monitoring specific body functions, in particular monitoring one or more concentrations of specific analytes. Without limiting the other possible configurations, the invention is described below with reference to a blood glucose monitoring device. In principle, however, the invention can also be transferred to other types of analytes.

In addition to so-called point measurements, in which a sample of a bodily fluid is taken from a user in a targeted manner and studied for analyte concentration, continuous measurements are increasingly becoming established. Thus, for example, in the recent past, a continuous glucose measurement in interstitial tissue (which is also referred to as continuous monitoring CM) has been established as an important method of managing, monitoring and controlling the state of diabetes, for example. Meanwhile, directly implantable electrochemical sensors, which are often also referred to as needle sensors (NTS), are generally used for this. In this case, the active sensor region is brought directly to the measurement site, which is generally arranged in the interstitial tissue and converts glucose, for example with an enzyme, for example glucose oxidase, into an electric current, wherein the electric current is proportional to the glucose concentration and can be used as the measurand. Examples of such transcutaneous measurement systems are described in US6360888B1 or US2008/0242962a 1.

Today's continuous monitoring systems are therefore typically transcutaneous systems. This means that the actual sensor part of the sensor with the electrodes is arranged under the skin of the user in the body tissue. However, the electronics part, which is often also referred to as evaluation and/or control part, or as circuit chip, is generally located outside the body of the user, i.e. outside the human or animal body. In this case, the sensor part is generally applied by means of an insertion aid (insertion aid), which is similarly described by way of example in US6360888B 1. Other types of insertion aids are also known. The time to wear the sensor is typically about 1 week.

Inserting the sensor fully or partially into the body tissue generally requires that the fully or partially implantable components of the sensor must be sterilized according to existing standards for use on humans and/or animals. In enzymatic based electrochemical glucose sensors, the enzyme is embedded directly in the electrode or is in contact with the interstitial tissue via a protective layer, i.e. the electrode is exposed. Chemical or thermal sterilization is accordingly generally excluded, since in this form of sterilization the enzymes of the electrodes are destroyed. Therefore, radiation sterilization can generally only be used.

However, there is a problem here: the electronic components of the sensor are generally not amenable to direct exposure to radiation, such as beta radiation or electron radiation, at the typically required radiation dose (typically 25 kGy). In particular, semiconductor-based active electronic components, such as, for example, high impedance amplifier components or voltage regulators, generally cannot withstand radiation sterilization with beta radiation at the radiation dose without suffering a loss of functionality.

The prior art discloses a number of methods with which the protection of the sensor element can be carried out during radiation sterilization. Thus, for example, a method for producing an integrated diagnostic test element is described in WO 2006/005503 a 1. The test element has a puncturing area and a detection area. The detection area on the test element is shielded from the electron radiation used for sterilization. It is also described, inter alia, that the test element can be arranged in a package and that the package can be designed such that the detection area of the test element is shielded from the influence of electron radiation and that an irradiation of the entire package is performed.

In US 5496302, a method is described for sterilizing selected areas of a product and producing a sterile product from two or more parts that cannot be sterilized in the same manner. This involves the use of a tubing system with sterile fluid, where one part of the housing is sterilized with electron radiation while the other part is protected from the electron beam by shielding.

In US 2008/0255440a1, a sensor package with an implantable sensor is described. The implantable sensor has an electrode region and an electrical contact region. The sensor is sterilized by beta radiation, the package being designed in such a way that the electrical contact areas are sterilized while the electrode areas remain protected. For example, the encapsulation may protect the sensor portion from other gases used to sterilize the electronic components.

In US 6594156B1, a device for protecting an electrical circuit during high energy radiation disinfection is described. The device comprises a carrier substrate and a protective housing for the electronic component. The protective enclosure is hermetically coupled to the carrier substrate of the electronic components and protects them from radiation sterilization. An electronic circuit is also described which is sterilised with a predetermined radiation dose and in which, after sterilisation, the gain factor is not reduced beyond a certain amount and the ratio between the collector current and the base current is maintained.

The solutions known from the prior art have many technical challenges, even drawbacks. Thus, known solutions are not generally set up for disinfecting a sensor or a sensor system that can be used on a human body without further complicated steps. In particular, it is generally not considered that such sensor systems have a skin-contacting part, which must be sterile on the one hand, but which must be in direct contact with sensitive electronic circuitry on the other hand. In order to sterilize the sensor system to the entire extent necessary with the known devices and methods, a plurality of successive sterilization methods are often used, such as, for example, radiation sterilization and chemical sterilization.

Furthermore, the devices known from the prior art are often so complex in design that they cannot be used in industrial processes in practice. Thus, before and after radiation sterilization, a complicated preparation or subsequent handling of the sterilization device is generally required, during which a recontamination of the sensor may occur. At the same time, however, the disinfection devices are so complex that they cannot generally be delivered to the end customer as a complete unit together with the shielding device.

Disclosure of Invention

Object of the Invention

It is therefore an object of the present invention to provide a method and a disinfection device for disinfecting an implantable sensor for sensing at least one analyte in body tissue, which at least substantially avoid the disadvantages of the above-mentioned methods and devices. In particular, it is intended to provide a method and a disinfection device which can be handled in an easy manner but still allow a comprehensive disinfection of the entire sensor and which can also be used on an industrial scale for the mass production of sensors.

Disclosure of the invention

This object is achieved by a method and a disinfection device for disinfecting an implantable sensor for sensing at least one analyte in body tissue according to the independent patent claims. Advantageous developments of the invention which can be realized individually or in any desired combination are given in the dependent patent claims.

The method can be performed here with a disinfection device according to the invention. On the other hand, the disinfection device may be arranged to perform the method according to the invention. Therefore, reference may be made to the description of the disinfection device for possible details of the method. On the other hand, with regard to possible details of the disinfection device, reference may be made to the features of the method, so that a suitable device may be used to arrange the disinfection device for performing and/or for use in the method. However, in principle other designs of the method and/or other designs of the disinfection device are also possible.

In a first aspect of the invention, a method for sterilizing an implantable sensor for sensing at least one analyte in body tissue is presented. An implantable sensor is generally understood to mean a sensor that can be introduced fully or partially into the body tissue of a human or animal user. A sensor for sensing at least one analyte in body tissue is generally understood to mean a device which is provided for the qualitative or quantitative detection of the presence of at least one analyte in body tissue. The at least one analyte may be a metabolite and/or another substance present in e.g. different concentrations in a human or animal body tissue, e.g. a body fluid contained in the body tissue. In particular, the at least one analyte may be an analyte selected from the group comprising blood glucose, milk and cholesterol. However, in principle other analytes are also detectable.

Disinfection is in principle a method of killing bacteria. In particular, these bacteria can be completely killed, so that after the disinfection method no bacterial growth is possible anymore. As described below, the sterilization may in particular comprise sterilization by means of ionizing radiation, particularly preferably by means of particle radiation, in particular by means of beta radiation and/or electron radiation. For example, the radiation may comprise electron radiation having an energy of 1.0MeV to 10MeV, in particular 2MeV to 3MeV, particularly preferably 2.5 MeV.

The sensor has at least one sensor part which can be introduced into the body tissue and has at least one sensor electrode for sensing an analyte, and at least one electronic part. The electronic part has at least one electronic component and is connected to the sensor part. In particular, such a connection may be or include a mechanical connection. Alternatively or preferably, this connection between the electronics part and the sensor part may additionally also comprise at least one electrical connection, for example at least one electrical connection between at least one electronic component of the electronics part and at least one sensor electrode of the sensor part, for example by means of at least one power supply line. In general, the electronics section may therefore preferably be mechanically and electrically connected to the sensor section.

The sensor portion may be fully or partially implanted in the body tissue of the user. For example, the sensor portion can be flexibly configured. For example, the sensor section can be designed completely or partially as a sensor strip, with a flexible substrate, which can be received in the body tissue. However, in principle other designs are also possible.

Disposing the at least one sensor electrode in such a manner enables the sensor to sense the at least one analyte by electrochemical means. The at least one sensor electrode may thus comprise, in particular, at least one working electrode and at least one further electrode. The at least one working electrode may for example comprise at least one conductive electrode layer coated with at least one enzyme, possibly with one or more additional substances. The at least one enzyme may be, for example, an enzyme suitable for the analyte to be detected. For example, the at least one enzyme may comprise glucose oxidase and/or glucose dehydrogenase. However, in principle other types of enzymes are also possible. Furthermore, the coating of the sensor electrode may comprise one or more mediators and/or one or more other auxiliary substances for the electrochemical detection of the at least one analyte. The at least one further electrode may preferably comprise at least one reference electrode and/or at least one counter electrode. For example, the at least one reference electrode may comprise an Ag/AgCl electrode. The at least one counter electrode may for example comprise a metal electrode, preferably of a noble metal, a carbon electrode or an electrode of a conductive polymer. However, in principle other designs of the electrodes are also possible. In particular, the at least one electrode may thus comprise two, three or more electrodes.

The sensor section is connected to the electronics section. In particular, the sensor part and the electronics part may together form one unit, which preferably cannot be separated without destroying the sensor. For example, the sensor portion and the electronics portion may share at least one substrate. The connection may also comprise a releasable or non-releasable adhesive connection or a clamping connection, which ensures a mechanical and electrical connection between the sensor part and the electronic part.

For example, the sensor portion may have a layered structure. In particular, the sensor portion may comprise at least one plastic substrate, such as a polyester fiber substrate or a polyimide substrate. Other designs are also possible.

The electronic part is preferably arranged outside the body tissue during sensing of the at least one analyte in the body tissue. The electronics section has at least one electronic component. The at least one electronic component may be connected directly or indirectly to the at least one electrode, in particular through a connection between the sensor part and the electronics part. In particular, the at least one electronic component may comprise at least one active semiconductor component. Particularly preferably, the electronic component may comprise at least one amplifier component, preferably a high impedance amplifier component with an input resistance of at least 1G Ω, preferably at least 100G Ω. In particular, the at least one electronic component may comprise a potentiostat.

For example, the electronic part may have at least one substrate, preferably a flexible substrate, for its part. The substrate may for example comprise a lead frame to which at least one component has been applied. The substrate of the electronics part may for example be connected to the substrate of the sensor. Furthermore, the electronics section may be connected to at least one electrode of the sensor section by one or more power lines.

The method has the following steps, which are preferably performed in the order indicated. In principle, different sequences are also possible. Furthermore, one or more method steps may also be performed in parallel or overlapping in time. Further, one or more of the method steps described below may be performed iteratively. Furthermore, the method may have one or more additional steps not mentioned.

In one method step (method step a)), the sensor is introduced into at least one package. The introduction is generally understood herein to mean that at least one sensor for the method is provided in a package. In this case, the sensor may be in a finished state, otherwise, in a semi-finished state as described in more detail below, wherein one or more subsequent method steps may still be required to bring the semi-finished sensor into a finished state available to the user. Both options are included within the scope of the concept of introducing the sensor into the package.

Within the scope of the invention, a package is generally understood to mean a device which surrounds, preferably completely surrounds, the sensor and insulates the sensor from environmental influences. Thus, the encapsulation insulates the sensor from the surroundings, making it sealed against bacteria, so that no bacteria can reach the sensor through the encapsulation. In this case, the package should generally not be considered as an integral part of the sensor and is generally designed in such a way that it is separate from the sensor for use of the sensor. The sensor can thus be accommodated in the encapsulation in a particularly movable manner. In particular, the package may preferably not be connected to the sensor. The encapsulation may for example be made completely or partly of a plastic material and/or completely or partly of a metal material. Particularly preferably, the package comprises at least one sheet, preferably at least one plastic sheet. For example, the plastic sheet may comprise at least one of the following plastics: PE, PP, PC, PET and PETG. However, other plastics may in principle also be used alternatively or additionally. Furthermore, metal sheets and/or sheets of synthetic material may also be used alternatively or additionally. The encapsulation may in particular be of deformable design, in particular of flexible design. Alternatively or additionally, however, the encapsulation may also be a completely or partially rigid design. The package may comprise at least one molded part, for example at least one plastic molded part, instead of or in addition to the wafer. For example, a molded portion that can be manufactured by an injection molding process, an injection blow molding process, or a similar forming process can be used.

The package also houses a radiation shield that shields the electronic portion. Radiation shielding is here to be understood to mean a device which attenuates the radiation used for disinfection by a factor of at least 10, preferably by a factor of at least 100. Details regarding possible designs of radiation shielding can be found, for example, in the following documents: w, femto player: experimental physics [ Experimental physics ], volume 4: kern-, Teilchen-und Astrophysik [ Nuclear, particle and astrophysics ], Springer Verlag, Heidelberg 1998, pp.91-92. For example, the radiation shield may have a plate-like element and/or a molded part through which the disinfecting radiation has to pass before reaching the electronic part when the plate-like element and/or the molded part is exposed to the directed disinfecting radiation. In this case, the electronic part can be completely or partially shielded by the radiation shield, at least the electronic component and/or at least one of the electronic components, preferably the semiconductor component, particularly preferably at least one high-impedance amplifier and/or at least one potentiostat, being shielded by the radiation shield.

The feature that the package accommodates the radiation shield is here understood on the one hand to mean that the radiation shield is an integral part of the package. On the other hand, however, as described in more detail below, the radiation shield may be loosely received in and/or on the package and, for example, designed such that it can be separated from the package. In particular, the encapsulation may fully or partially encapsulate the radiation shield. For example, the radiation shield may be housed in the interior space of the package. However, alternatively or additionally, the radiation shield may also be arranged completely or partially outside the inner space of the encapsulation, such that at least one wall of the encapsulation is arranged between the inner space and the radiation shield. For example, the radiation shield may be arranged completely or partially in one or more recesses of the package protruding into the interior space such that the radiation shield protrudes into the interior space of the package, but at least one wall of the package is preferably arranged between the interior space and the radiation shield. Various designs are possible and are described in more detail below by way of example. All options, i.e. the option that the radiation shield is arranged within the package or only on the package, are intended to be included by the features of the package accommodating the radiation shield.

The encapsulation and the radiation shield preferably form one unit, whether separable or not.

In a further method step (method step b)) which is preferably carried out completely after method step a), the sensor is irradiated in the package with disinfecting radiation from at least one irradiation direction. For example, the sensor may be irradiated with sterilizing radiation from one irradiation direction and/or from two irradiation directions. Such irradiation may preferably be performed completely such that the entire sensor is irradiated with disinfecting radiation, except for those parts that are shielded by the radiation shield. However, in principle, spot illumination is also possible. However, it is preferred to perform the irradiation over a large area so that all components of the sensor are initially irradiated, but as mentioned above, the radiation shield shields one or more regions of the sensor from the disinfecting radiation.

Disinfecting radiation is to be understood as meaning in general ionizing radiation having a germicidal effect. In principle, this can be electromagnetic radiation and/or particle radiation. However, as mentioned above, it is particularly preferred to use particle radiation, in particular beta radiation and/or electron radiation. For example, during radiation sterilization with sterilizing radiation, the sensor may be exposed to a dose of at least 5kGy, particularly preferably a dose of at least 10kGy, in particular a dose of at least 20kGy, or even a dose of at least 25 kGy. One or more radiation sources may be used, for example for radiation disinfection, such as radioactive beta emitters and/or electron radiation sources. In radiation sterilization, i.e. irradiation of the sensor with sterilization radiation, which is preferably performed by being directed from at least one spatial direction, preferably at least two spatial directions, a radiation shield shields the electronic components of the electronic part from the sterilization radiation. If a plurality of electronic components are contained, the radiation shield can in particular shield at least one of these electronic components, for example at least one semiconductor component, preferably an active semiconductor component, in particular at least one amplifier, preferably at least one high-impedance amplifier, particularly preferably a potentiostat. Furthermore, arranging the radiation shield in this way enables the sensor portion to be disinfected by the disinfecting radiation. In contrast to the above-mentioned prior art, which generally shields the sensor part, it is therefore proposed in the present case to shield the electronics part completely or partially, but to sterilize the sensor part to be implanted, which is introduced directly into the body tissue. It is thus possible to give at least one sensor electrode, for example a sensor chemical, for example at least one enzyme, radiation damage which is generally negligible, or which can be compensated by appropriate calibration after radiation sterilization. At the same time, however, sensitive semiconductor components, such as, for example, potentiostats, may be shielded from the sterilizing radiation, so that the radiation sterilization generally does not bring any loss of function to these components. In this way, the sensor can be produced in particular in one piece or in the form of a unit, wherein the electronics are in particular completely or partially protected against radiation damage. During and after radiation sterilization the sensor can be held in a package, which is preferably completely closed during radiation sterilization and which, for example, can prevent recontamination of the sensor after radiation sterilization. The sensor may be delivered to the end customer in the package, which opens the package, for example, to fully or partially implant the sensor. For example, for such opening, the package may have at least one predetermined breaking point, for example a weakening of the wall thickness, along which tearing open the package is possible. Openings may also be provided that are closed with a plug or screw.

As mentioned above, in method step a), a sensor may be provided within the package. As similarly described, in this case the sensor may be provided as a finished sensor or as a semi-finished product, i.e. an intermediate product. In the latter case, one or more method steps may be required in order to complete the final assembly of the sensor. It is particularly preferred that the method is performed in such a way that such final assembly takes place within the package without the need to open the package. Such a final assembly can be carried out in particular after the radiation sterilization of method step b). After the sensor has been introduced into the encapsulation, the encapsulation can preferably be closed, in particular such that it is sealed against bacteria, for example by at least one closing element and/or by interlocking engagement, for example welding. For example, the sheets and/or sheet portions of the package may be soldered.

Thus, after carrying out method step a), the sensor can have in particular at least a first part and at least a second part. The first part can be sterilized in method step b). On the other hand, in method step b), the second portion may be completely or partially (i.e. completely or e.g. in a specific area) shielded from the disinfecting radiation by the radiation shield. After the execution of method step b), i.e. after the execution of the radiation sterilization, the first part and the second part can be connected within the package, in particular without opening the package.

This means that the packaging is preferably designed in such a way that an external intervention by the user is possible, in such a way that the first part and the second part can be connected to each other within the packaging after radiation sterilization. For this purpose, the encapsulation may for example be of deformable design, in such a way that the described final assembly is possible, wherein the first part and the second part are connected to each other within the encapsulation.

Thereby, the encapsulation may generally be deformable in such a way that the first part and the second part are moved relative to each other when there is deformation of the encapsulation after performing method step b), in such a way that they are connected to each other. In particular, the first and second parts may be pressed against each other. As will be described in more detail below, this may be done by guiding the first and second parts by at least one compression means during the movement triggered by the deformation of the package, the first and second parts being pressed against each other by the compression means. Such a design is described in the following with particular reference to a layered structure of a sensor, one or more layers of which are sterilized as a first part and one or more other layers of which are shielded as a second part, either completely or partially, i.e. as a whole or in at least one area, from sterilizing radiation during radiation sterilization. However, in addition to the layered structure, in principle other designs of the final assembly within the package are also possible.

In a preferred design of the method, the electronic part is designed in such a way that it has a layered structure as a whole or in at least one region. A layered structure should be understood to generally mean a structure in which one or more layers are applied one on top of the other. For example, at least one of the layers may have at least one lead frame to which at least one electronic component of the electronic part has been applied and/or into which at least one electronic component of the electronic part has been introduced. The layered structure has at least one coating. In method step b), the coating is arranged in this case with respect to the radiation shield in such a way that the coating is at least partially sterilized by the sterilizing radiation. A coating is in this case to be understood to mean a layer which covers at least one further layer and/or at least one further component (for example an electronic component) in the layered structure. For example, for a sensor that is finally assembled, the cover may represent a layer that forms the surface of the sensor and is, for example, capable of contacting the skin and/or bodily fluids and/or bodily tissues of the user.

The cover may in particular comprise an adhesive layer, in particular at least one adhesive layer for fixing the implantable sensor on the skin surface. Thereby, the implantable sensor may especially be designed in such a way that the sensor portion protrudes through the at least one insertion opening into the body tissue, while the electronic portion is arranged completely or partially outside the body tissue, for example on the surface of the skin of the user. The electronic part may be fixed to the surface of the user's skin by means of the at least one adhesive layer, e.g. a mastic.

The method can also be designed in such a way that, as described above, radiation sterilization is carried out after the final assembly, in which the coating is applied to one or more other layers. In particular, after the execution of method step b), a coating which has then been sterilized can be applied to the electronic component within the encapsulation. Such application may be performed directly or indirectly, i.e., such that the cover layer directly contacts the at least one electronic component, or indirectly contacts the at least one electronic component through one or more intervening layers, e.g., one or more other layers and/or one or more seals, applied between the cover layer and the electronic component. Various designs are possible. In any case, the application may be performed in such a way that at least one coating is arranged between the electronic component and the outer surface of the sensor. The application of the coating to the electronic component may in particular be performed in such a way that during such application the encapsulation is not opened. During final assembly, the sensor is thus still fully protected from recontamination by the encapsulation.

After the coating has been applied, the coating may in particular form the outer surface of the sensor, in particular the outer surface of the electronic part of the sensor, as described above. This can be designed in particular in such a way that the outer surface of the electronics part, particularly preferably the entire surface of the implantable sensor, is thoroughly sterilized. In other words, the method can be performed in such a way that the surface of the sensor is completely sterilized by radiation even in the region of the electronics part, while nevertheless the at least one electronic component can be protected from radiation damage with radiation shielding and subsequent final assembly within the package.

As mentioned above, the encapsulation may in particular be of a completely or partially deformable design. This said final assembly may be done by deformation, wherein the first and second parts are connected to each other, in particular by applying a coating to the electronic component. The encapsulation can thereby in particular be of deformable design in such a way that, in the presence of deformation of the encapsulation, the sensor is moved, in particular pulled, by at least one compression means which will laminate the cover layer onto the electronic component. Such a compression means, which may for example comprise at least one gap, may be designed in various ways. This gap is preferably not rigidly formed to avoid damage to the sensor. In this way, for example, a lamination process may be performed to laminate the cover layer to the at least one electronic component. For example, the compression means may be formed by at least one pressure pad in the package, which interacts with the counter element, e.g. a rigid counter element and/or another pressure pad, enabling a gap to be formed between the pressure pad and the counter element.

The deformation of the encapsulation may in particular be performed by using a stretchable and/or deformable flexible encapsulating material. Alternatively or additionally, the encapsulation may also have, for example, a specific deformable element, such as at least one bellows.

As mentioned above, the radiation shield may be an integral part of the package, or may however only be connected to and/or accommodated in and/or on the package, so that the radiation shield itself does not form an integral part of the actual package. In the latter case, the radiation shield can be separated from the encapsulation, in particular after carrying out method step b), for example for the purpose of sterilization of other sensors. Thereby, the radiation shield may be designed in particular as a reusable radiation shield.

This separation of the radiation shield from the package may include, inter alia, removing the radiation shield from a complete or partial encapsulation of the radiation shield by the package. The separation can in particular be performed simultaneously or at least overlapping in time or in one operation with the deformation of the above-mentioned package. Thereby, during deformation of the package, the radiation shield may be simultaneously separated from the package, in particular completely or partially removed from the complete or partial encapsulation of the package. For example, the radiation shield may have been inserted into at least one finger of the encapsulation from the outside before the encapsulation is deformed, the finger protruding into the inner space of the encapsulation. For example, the package may generally form an interior space that houses and stores the sensor such that it is sealed against bacteria during radiation sterilization, preferably during final assembly. The interdigitated fingers are understood to mean the projections of the inner walls of the encapsulation into the inner space. For example, the fingers may form or include at least one dimple that protrudes into the interior space. This finger can be of tubular design and/or be designed in some other way so that the radiation shield likewise projects into the inner space and is able to shield the electronic part of at least one electronic component during radiation sterilization. Thus, the radiation shield may generally be arranged in such a way that it is not accommodated in the interior space, so that, for example, the radiation shield itself does not have to be sterile and, for example, can be reused without the radiation shield needing to be sterilized.

In particular, the method can be carried out in such a way that during the removal of the radiation shield, the packaging fingers which project into the packaging during the radiation sterilization, in particular into the packaging interior, are pulled out of the interior of the packaging. This may be performed, for example, in the same way as if the fingers of the glove were turned inside out when pulling the hand. Examples are described in more detail below.

In particular, the package may be of deformable design in such a way that the radiation shield may be moved together with the second package portion of the package, for example by connecting the sensor to the first package portion of the package by a releasable connection, the first package portion and the second package portion being connected to each other during deformation of the package in such a way as to continue to ensure a bacterial-tight shielding of the sensor, for example until the user opens the package to remove the sensor from the package.

During the deformation of the encapsulation, a coating may be applied, in particular adhered and/or laminated, over a large area from at least one side to the substrate carrying the electronic component. However, as mentioned above, in principle other types of final assembly are also possible.

The package may also have at least one handle, preferably at least two handles, for the user to grip the package when performing the deformation. For example, at least a first handle may be attached to the first enclosing section described above and at least a second handle may be attached to at least the second enclosing section.

In particular, the radiation shield may comprise at least one metallic radiation shield. In particular, the metallic radiation shield may have a thickness of 1mm to 10mm, preferably 3mm to 7mm, particularly preferably 5 mm. However, in principle other designs are also possible. In particular, the metallic radiation shield may be completely or partially manufactured from at least one metallic material selected from the group consisting of aluminum, iron, steel, lead and copper. However, it is also possible to use other metals instead or in addition. The metal and/or other metal may be in pure form and/or in the form of an alloy.

In addition to the sensor, at least one further element may also be accommodated in the package and preferably be sterilized simultaneously during radiation sterilization. Thus, for example, in method step a), at least one medical aid can be additionally introduced into the packaging, i.e. provided in the packaging. A medical aid should be understood to generally mean a device that can be used in a medical procedure, i.e. a device that is used during a diagnostic and/or surgical and/or therapeutic procedure. In particular, the medical aid may be a disposable aid. For example, the medical aid may be a device capable of contacting a body fluid and/or open body tissue of a user. In particular, the medical aid may comprise at least one insertion aid. For example, an insertion aid should be understood to mean an element provided for introducing at least a sensor portion of a sensor into body tissue. For example, the insertion aid may comprise at least one cannula. With regard to the possible designs of the implantable sensor and with regard to the possible designs of the insertion aid, reference is in principle made to the above description of the prior art. However, in principle other designs are also possible.

As mentioned above, in a further aspect of the invention a disinfection device for disinfecting an implantable sensor for sensing at least one analyte in body tissue is presented. A sterilizing device is here to be understood as meaning generally a device which can accommodate a sensor during radiation sterilization and preferably also after radiation sterilization. The disinfection device can, for example, be reversibly inserted as a whole into a disinfection apparatus, which has, for example, a radiation source for generating disinfection radiation, for example a beta radiation source and/or an electron radiation source. The disinfection device may for example form a unit that can be handled as a whole and for example can be delivered to the end customer or user completely or partially at a later time.

The disinfection device is in particular used in a method according to one or more of the designs described above and/or according to one or more exemplary embodiments described in more detail below.

The disinfection device comprises at least one implantable sensor for sensing at least one analyte in the body tissue. The sensor has at least one sensor portion that can be introduced into body tissue and has at least one sensor electrode that senses an analyte, and at least one electronics portion. The electronic part has at least one electronic component and is connected to the sensor part. With regard to other possible designs of the sensor, reference may be made to the above description.

The disinfection device further comprises at least one package. The package isolates the sensor so that it is sealed from bacteria. The package houses at least one radiation shield that shields the electronic components of the electronic portion during radiation sterilization. As mentioned above, the radiation shield may be an integral part of the package or may be releasably accommodated in the package, i.e. connected to the package, in such a way that the radiation shield may be separated from the package after radiation sterilization. With regard to other possible designs, reference may be made to the above description.

In particular, the radiation sterilisation may be arranged in such a way that it can be used during the method according to the invention.

Thereby, in particular, the sensor may have at least a first portion which may be sterilized in the package during radiation sterilization and at least a second portion which is shielded by the radiation shield during radiation sterilization, the first portion and the second portion being connectable within the package after performing radiation sterilization, in particular without opening the package. The sterilizing device may thus be arranged in such a way that the final assembly of the sensor within the package may be performed after radiation sterilization.

In particular, as described above, the package may be of a deformable design. During deformation of the package after performing the radiation sterilization, the first part and the second part may be moved relative to each other in such a way that they may be connected to each other. In particular, the first and second parts may be pressed against each other.

As mentioned above, the electronic part may in particular have at least one layered structure. In particular, the layered structure may have at least one cover layer, and the encapsulation may be designed in such a way that during radiation sterilization the cover layer is arranged in such a way with respect to the radiation shield that the cover layer may be at least partially sterilized by the sterilizing radiation, while the electronic components are shielded. The encapsulation may be designed in such a way that after the radiation sterilization has been performed, a coating may be applied to the electronic component, in particular pressed onto and/or laminated onto it within the encapsulation, in particular without opening the encapsulation. As mentioned above, the encapsulation may in particular be of deformable design in such a way that during deformation of the encapsulation the cover layer can be laminated to the electronic component by the compression means by the at least one compression means moving, in particular pulling, the sensor. In particular, the compression means may be formed in the package by at least one pressure pad.

In particular, the encapsulation may be designed in such a way that during the deformation the radiation shield may be simultaneously separated from the encapsulation, in particular completely or partially removed from the complete or partial encapsulation by the encapsulation. Thus, for example, the radiation shield may have been inserted into at least one finger of the encapsulation from the outside before the encapsulation is deformed, the finger protruding into the inner space of the encapsulation. During the removal of the radiation shield, the encapsulated fingers can preferably be pulled out of the inner space of the encapsulation. For other possible designs, reference may be made to the above description.

In particular, the package may be of deformable design in such a way that the sensor is connected to a first package part of the package, the radiation shield may be moved together with a second package part of the package, the first and second package parts remaining connected to each other during deformation of the package in such a way as to ensure a bacterial-tight shielding of the sensor during deformation.

As mentioned above, the package may in particular have at least one bellows. For example, the first enclosing section and the second enclosing section may be connected to each other by a bellows. The package may also have at least two handles, such as a first handle connected to the first package portion and a second handle connected to the second package portion. The provision of these handles may facilitate the deformation of the package.

As mentioned above, the package may in particular also have at least one sheet, preferably at least one plastic sheet and/or at least one metal sheet and/or at least one laminate sheet. In particular, the sheet may be attached in the area of the package through which the sterilizing radiation passes during sterilization. For example, the sheet may have a thickness of at most 1mm, preferably at most 500 μm, particularly preferably from 10 μm to 100 μm. In particular, the encapsulation may have one or more of the above-mentioned plastics.

The hermetic and/or aseptic sealing of the package can be checked by well-known pressure or vacuum methods before or after sterilization.

As also mentioned above, in particular, the package may have at least one predetermined breaking point for irreversible opening and removal of the sensor by, for example, the end customer and/or the user. Thus, for example, method steps a) and b) may be performed by the manufacturer within the package, possibly also the final assembly of the sensor. The sensor may then be stored and delivered to, for example, an intermediate agency and/or an end customer who can, for example, remove the sensor after opening the package to insert the sensor into the body tissue. The opening is performed, for example, by tearing off a predetermined breaking point, by removing a plug or by removing a screw closure. For example, the predetermined breaking point may comprise at least one weakening in the package, for example a material weakening in the form of a linear weakening, along which the package can be torn open and opened. However, in principle other designs are also possible. The method and the disinfection device according to one or more of the designs described above have numerous advantages over the known methods and devices. In particular, it is now possible to sterilize a sensor having an electronics part and a sensor part, which can also be formed in one piece, without any problems. Specifically, for example, a commercially available voltage regulator can be used. For example, it can withstand 25kGy of radiation sterilization without loss of function.

Although the devices and methods known from the prior art are not provided for the purpose of disinfecting sensor systems for use on human and/or animal bodies without further complicated steps, this is possible without any problems according to the invention. In particular, the sensor may now have a part which is in contact with the skin and/or body tissue and/or body fluid, which on the one hand must be sterile, but on the other hand is in direct contact with sensitive electronic circuitry. The sensor system of the sensor can now be sterilized to the full extent necessary, for example, without having to work with different sterilization methods. Thus, for example, according to the invention, radiation disinfection can be used solely without, for example, additional chemical disinfection being required.

Furthermore, additional manufacturing work steps and additional handling steps in the application can be dispensed with. Thereby, the sensor unit, which is finally assembled in a completely sterile state, can be manufactured without further steps on the part of the user being required next, but only with constant insertion into the body tissue.

An implantable sensor portion, which may be implanted subcutaneously, is connected to the electronics portion. The electronic part may serve, in whole or in part, as an activation or evaluation part of the sensor. Thus, for example, an electronic part may be provided to perform signal processing and/or pre-processing of the signals. The electronic part may also be provided as a communication part and may for example comprise one or more interfaces of sensors with which the sensors can for example communicate measurement data to a user and/or one or more other devices. Furthermore, the electronic part can also comprise at least one energy source, i.e. for example a separate energy source and/or an energy store and/or at least one connection enabling energy supply. The implantable sensor portion and all other portions that contact the skin can be sterilized by beta radiation. The electronic circuitry may be fully or partially protected by a radiation shield, preferably a metallic shield. The radiation shield may optionally be removed from the encapsulation, which is preferably possible during this step for the final assembly to be performed, e.g. the connection between the previously shielded part and the fixation means for fixing the part on the human skin. Thereby, the above-mentioned first part to be sterilized in method step b) may comprise such fixing means for fixing the sensor on the human skin, for example at least one adhesive layer.

Commercially available electronic circuitry can generally be used in the electronics portion of the sensor, despite the necessary sterilization, for example, with a high energy beam. Thus, commercially available electronic components, in particular in the form of semiconductor components, can be used without fear of radiation damage.

It should be noted that as a further advantage, the option of removing the radiation shield allows for a low profile when applying the sensor system to a patient. Thus, by removing the radiation shield, the package volume in which the sensor is housed can be made extremely small, so that the unit comprising the package and the sensor can be delivered to the end customer. Thereby, the cost and weight of the radiation shield can be saved. It is also advantageous that various components, such as the sensor tip, the split cannula, and the adhesive membrane contacting the skin, can be sterilized together in a sterile sealed package (which may serve as an external package). After sterilization, the components may be assembled without opening the package, which acts as a sterile enclosure, and/or may be brought into a new relative position with respect to each other.

In summary, the following examples are particularly preferred within the scope of the present invention.

Example 1: a method for disinfecting an implantable sensor for sensing at least one analyte in body tissue, wherein the implantable sensor has at least one sensor part which can be introduced into the body tissue and has at least one sensor electrode for sensing the analyte, and at least one electronics part having at least one electronic component and being connected to the sensor part, the method having the following steps:

a) the implantable sensor is introduced into at least one package that insulates the implantable sensor such that it is sealed against bacteria, the package containing a radiation shield that shields the electronic portion,

b) the implantable sensor is irradiated in the package with sterilizing radiation, in particular with electronic radiation, from at least one irradiation direction, the radiation shield shielding electronic components of the electronic part from the sterilizing radiation, the radiation shield being arranged in such a way that the sensor part is sterilized by the sterilizing radiation.

Example 2: the method according to the preceding embodiment, wherein after performing method step a), the implantable sensor has at least a first part which is sterilized in method step b) and at least a second part which is shielded from sterilizing radiation by the radiation shield in method step b), wherein after performing method step b) the first part and the second part are connected within the encapsulation, in particular without opening the encapsulation.

Example 3: according to the method of the preceding embodiment, the encapsulation is of deformable design in such a way that the first part and the second part are moved relative to each other when there is deformation of the encapsulation after performing method step b), in such a way that they are connected to each other, in particular the first part and the second part are pressed against each other.

Example 4: according to the method of one of the preceding embodiments, the electronic part has a layered structure with at least one coating, wherein in method step b) the coating is arranged with respect to the radiation shield in such a way that it is completely or partially disinfected by the disinfecting radiation.

Example 5: according to the method of the previous embodiment, the cover comprises an adhesive layer, in particular for fixing the implantable sensor on the skin surface.

Example 6: the method according to one of the two preceding embodiments, wherein after performing method step b), a coating is applied to the electronic component within the encapsulation, in particular without opening the encapsulation.

Example 7: the method according to the preceding embodiment, wherein after applying the coating, the coating forms an outer surface of the electronic part.

Example 8: the method according to one of the two preceding embodiments, the encapsulation being of deformable design in such a way that, in the presence of deformation of the encapsulation, the implantable sensor is moved, in particular pulled, by at least one compression means, by which the cover is laminated onto the electronic component.

Example 9: according to the method of the previous embodiment, the compression means is formed in the package by at least one pressure pad.

Example 10: the method according to one of the two preceding embodiments, the package comprising a bellows.

Example 11: the method according to one of the three preceding embodiments, wherein the radiation shield is separated from the package during deformation of the package.

Example 12: the method according to the preceding embodiment, wherein the radiation shield has been inserted from outside into at least one finger of the encapsulation, which finger protrudes into the inner space of the encapsulation, in particular from outside, before the deformation of the encapsulation.

Example 13: the method according to the preceding embodiment, wherein the fingers of the encapsulation are pulled out of the inner space of the encapsulation during the removal of the radiation shield.

Example 14: according to the method according to one of the six preceding embodiments, the encapsulation is of deformable design in such a way that the sensor is connected to a first encapsulation part of the encapsulation, the radiation shield being movable together with a second encapsulation part of the encapsulation, the first encapsulation part and the second encapsulation part remaining connected to each other during deformation of the encapsulation in such a way as to ensure a bacteria-tight shielding of the sensor.

Example 15: the method according to one of the seven preceding embodiments, wherein during deformation of the encapsulation a coating is applied, in particular adhesively attached and/or laminated thereon, over a large area from at least one side to the substrate carrying the electronic component.

Example 16: according to the method of one of the eight preceding embodiments, the package has at least one handle, preferably at least two handles, for the user to grip the package when performing the deformation.

Example 17: the method of one of the preceding embodiments, the radiation shield comprising at least one metallic radiation shield.

Example 18: according to the method of the preceding embodiment, the metallic radiation shield has a thickness of 1mm to 10mm, preferably 3mm to 7mm, particularly preferably 5 mm.

Example 19: the method according to one of the two preceding embodiments, the metallic radiation shield comprises at least one metal selected from the group comprising aluminum, iron, steel, lead and copper.

Example 20: the method according to one of the preceding embodiments, wherein in method step a) at least one medical aid, in particular at least one insertion aid, is additionally introduced into the packaging.

Example 21: a disinfection device for disinfecting an implantable sensor for sensing at least one analyte in body tissue, in particular for use in a method according to one of the preceding embodiments, the disinfection device comprising:

at least one implantable sensor for sensing at least one analyte in body tissue, wherein the implantable sensor has at least one sensor section which can be introduced into the body tissue and has at least one sensor electrode for sensing the analyte, and at least one electronics section which has at least one electronic component and is connected to the sensor section;

-at least one encapsulation insulating the implantable sensor such that it is sealed against bacteria, the encapsulation housing at least one radiation shield shielding electronic components of the electronic part during radiation sterilization.

EXAMPLE 22A disinfection device according to the preceding embodiment, provided for use in a method according to one or more of embodiments 1-19.

Example 23: according to a disinfection device as claimed in one of the two preceding embodiments, the sensor has at least a first part which is sterilizable in the encapsulation during radiation disinfection and at least a second part which is shielded by the radiation shield during radiation disinfection, the first part and the second part being connectable within the encapsulation after radiation disinfection has been performed, in particular without opening the encapsulation.

Example 24: according to a disinfection device as described in the preceding embodiments, the encapsulation is of deformable design in such a way that when there is deformation of the encapsulation after the radiation disinfection has been carried out, the first part and the second part are moved relative to each other in such a way that they are connected to each other, in particular the first part and the second part are pressed against each other.

Example 25: the disinfection device according to one of the preceding embodiments relating to a disinfection device, the electronics part having a layered structure with at least one cover layer, wherein the encapsulation is designed in such a way that during radiation disinfection the cover layer is arranged relative to the radiation shield in such a way that the cover layer can be at least partially disinfected by disinfection radiation, while the electronic components are shielded.

Example 26: according to the sterilizing unit of the preceding embodiments, the package is designed in such a way that after performing the radiation sterilization, a coating can be applied to the electronic components within the package, in particular without opening the package.

Example 27: according to a disinfection device as described in the preceding embodiments, the encapsulation is of deformable design in such a way that when there is deformation of the encapsulation, the implantable sensor is moved, in particular pulled, by at least one compression means, by which the cover is laminated onto the electronic component.

Example 28: the disinfection device according to the previous embodiment, the compression means is formed in the package by at least one pressure pad.

Example 29: a disinfection device as claimed in one of the two preceding embodiments, wherein the radiation shield can be detached from the encapsulation during deformation of the encapsulation.

Example 30: a disinfection device as claimed in one of the three preceding embodiments, wherein the radiation shield has been inserted from outside into at least one finger of the encapsulation, which finger protrudes into the inner space of the encapsulation, before the encapsulation is deformed.

Example 31: the disinfection device according to the previous embodiment, wherein the fingers of the package are pulled out of the inner space of the package during removal of the radiation shield.

Example 32: the disinfection device according to one of the five preceding embodiments, the encapsulation being of deformable design in such a way that the sensor is connected to a first encapsulation part of the encapsulation, the radiation shield being movable together with a second encapsulation part of the encapsulation, the first encapsulation part and the second encapsulation part remaining connected to each other during deformation of the encapsulation in such a way as to ensure a bacteria-tight shielding of the implantable sensor.

Example 33: the disinfection device as described above in relation to one of the embodiments of the disinfection device, the package having a bellows.

Example 34: the disinfection device as described above in relation to one of the embodiments of the disinfection device, the package having at least two handles.

Example 35: the disinfection device as described in one of the previous embodiments with regard to the disinfection device, the package having a plastic sheet.

Example 36: the disinfection device as described in one of the previous embodiments with regard to the disinfection device, the package having a predetermined breaking point for irreversibly opening and removing the implantable sensor.

Drawings

Further details and features of the invention will be apparent from the following description of preferred exemplary embodiments, especially in conjunction with the claims. The respective features may be realized here independently or in combination with each other. The invention is not limited to the exemplary embodiments. Exemplary embodiments are schematically illustrated in the drawings. Accordingly, like reference numbers in various figures indicate identical or functionally corresponding elements.

In the drawings:

fig. 1 shows a first exemplary embodiment of a disinfection device according to the present invention and a method according to the present invention; and

fig. 2 shows a second exemplary embodiment of a disinfection device according to the present invention and a method according to the present invention;

FIG. 3 shows a detailed illustration of the means for housing the radiation shield in the package;

fig. 4 shows a third exemplary embodiment of a disinfection device according to the present invention;

fig. 5 shows a fourth exemplary embodiment of a disinfection device according to the present invention and a method according to the present invention;

fig. 6 shows a fifth exemplary embodiment of a disinfection device according to the present invention and a method according to the present invention.

Detailed Description

In fig. 1, a first exemplary embodiment of a disinfection device 110 according to the present invention for disinfecting an implantable sensor 112 is shown in a schematic sectional view. Meanwhile, the exemplary embodiment shown in fig. 1 shows an example of a method according to the invention for sterilizing an implantable sensor 112.

In general, also in the present exemplary embodiment, the disinfection device 110 can be designed as a sterile package and has a package 114, which package 114 is preferably designed such that it is sealed against bacteria and has an interior space 116 and insulates the latter such that it is sealed against bacteria. The implantable sensor 112 is housed in the interior space 116.

The implantable sensor 112 has an electronics portion 118 and a sensor portion 120, the sensor portion 120 being connected to the electronics portion and implantable in the body tissue of the user. The sensor portion 120 has at least one sensor electrode 122, typically 2, 3 or more sensor electrodes 122. As described above, these may be, specifically, enzymatic sensor electrodes 122. For example, at least one sensor electrode 122 may have been applied to a substrate 124. This may be, for example, a plastic substrate 124, having a single layer or a multi-layer structure. The substrate 124 may also be or include a flexible printed circuit board, for example.

The sensor electrodes 122 may be connected to the electronics portion 118 via one or more power lines not shown in fig. 1. The electronics portion 118 and the sensor portion 120 may be formed in one piece, so preferably they cannot be separated without being damaged.

The electronics 118 preferably also has at least one substrate 126. The substrate may be, for example, a lead frame. Such a lead frame is preferably again of flexible design, for example in the form of a flexible printed circuit board. One or more electronic components 128 are disposed on and/or in the leadframe and/or substrate 126. For example, these electronic components 128 may comprise one or more semiconductor components, in particular one or more active semiconductor components, such as for example amplifier components. In particular, the at least one electronic component 128 may include at least one voltage regulator, which may be in one or more pieces. Together, the electronic components 128 may form an activation and/or evaluation circuit for the implantable sensor 112. In addition, one or more interfaces may also be provided for the implantable sensor 112 to communicate with one or more other components not shown.

In the illustrated exemplary embodiment, the implantable sensor 112, and here in particular the electronics portion 118, is of multi-part design and includes at least a first portion 130 and at least a second portion 132. For example, the first portion 130 may include at least one coating 134 that preferably later covers the electronic component 128. For example, the cover 134 may include a first adhesive layer 136, with the first adhesive layer 136 the cover 134 may be adhered to the electronic component 128 and/or the substrate 126. In the initial state shown in fig. 1, this first adhesive layer 136 may also be covered by a cover layer 138. This cover layer 138 may be peeled off later before the cover layer 134 is adhered to the substrate 126. For example, the cover 138 can be designed as a protective film.

Furthermore, the cover 134 may have at least a second adhesive layer 140 on the side facing away from the substrate 126. With this second adhesive layer 140 (which may generally also be replaced by any desired fixing element), the electronic part 118 may for example be fixed on the surface of the skin of the user of the implantable sensor 112, while the sensor part 120 has been inserted into the body tissue of the user, either completely or partially, through an insertion opening in the skin surface of the user. The second adhesive layer 140 may also be covered by a cover layer 142, for example in turn covered by a protective film.

Furthermore, the disinfection device 110 has at least one radiation shield 144. For example, as shown in fig. 1, this radiation shield 144 may be housed in the interior space 116. Alternatively, the radiation shield 144 may however also be accommodated completely or partially outside the inner space 116, as an integral part of the encapsulation 114 or as a separate integral part.

The radiation shield 144 may be, for example, a metallic radiation shield, which is completely or partially manufactured from at least one metallic material, in particular at least one metallic solid material. For example, the radiation shield 144 may have a thickness d perpendicular to the radiation direction 146, which may be, for example, 1 to 10mm, in particular 5 mm. For example, the radiation shield 144 may include an aluminum plate.

In the case of the method according to the invention for disinfecting an implantable sensor 112, firstly, in the state shown in fig. 1, the irradiation of the sensor 112 can be carried out for the purpose of radiation disinfection, for example with beta radiation having an energy of 2.5 MeV. In particular, in this case, the implantable sensor 112 may be exposed to a radiation dose of 25 kGy. Other types of radiation sterilization are also possible. The radiation sterilization is preferably performed in a directed manner from one spatial direction, or as described in more detail below, from two, three or more spatial directions. During radiation sterilization, the sensor portion 120 and the first portion 130 of the electronics portion 118 (i.e., the cladding 134) are sterilized by radiation sterilization. On the other hand, the radiation shield 144 shields the disinfecting radiation from the second portion 132, the second portion 132 comprising at least one electronic component 128 or at least one of the electronic components 128. For this purpose, the radiation shield 144 is preferably designed geometrically in such a way as to ensure a reliable shielding of the second part 132 for all spatial directions of the disinfecting radiation under consideration, the second part 132 comprising at least one electronic component 128 or at least one of the electronic components 128. In particular, in this way all electronic components 128 or at least one or more of these electronic components 128, for example at least one sensitive component of the electronic components 128, can be shielded from the disinfecting radiation.

For example, the encapsulation 114 can be designed completely or partially as a plastic encapsulation. In particular, the package 114 may include a plastic sheet. After radiation sterilization, the package 114 may be handled in such a way that the first portion 130 and the second portion 132 are connected within the hermetically sealed package 114 without the need to open the package 114. In particular, the cover 134 may thereby be applied to the at least one electronic component 128 and/or the substrate 126, e.g., laminated and/or adhered. To accomplish this, the package 114 may be of a flexible design, for example. In this case, the encapsulation 114 may be deformed, for example, in such a way that the radiation shield 144 is removed from the region between the first portion 130 and the second portion 132 is applied to the first portion 130. For example, an operator may grasp the left end of the enclosure 114 and the right end of the enclosure 114 in FIG. 1 and pull them apart directly after the sterilization operation. In such a design, the radiation shield 144 is preferably connected to the left end of the enclosure 114 such that during pulling apart, deformation of the enclosure 114 occurs in such a way that the radiation shield 144 is pulled out of the area between the first portion 130 and the second portion 132. As also shown in fig. 1 as an alternative, the radiation shield 144 may be connected to the cover layer 138, e.g., the protective film of the adhesive layer 136, by at least one connection 148. Thus, the cover layer 138 may also be removed simultaneously as the radiation shield 144 is pulled out of the intermediate space between the first portion 130 and the second portion 132. In principle, however, other designs are also possible, for example designs in which the cover layer 138 is removed separately and/or in which the cover layer 138 is absent and/or in which the first adhesive layer 136 is absent.

At the same time, the above-described deformation process during pulling apart of the encapsulation 114 allows the height of the encapsulation 114 in fig. 1 to be reduced in such a way that the first portion 130 and the second portion 132 are pressed together. In this way, the implantable sensor 112 shown in fig. 1 and designed as a semi-finished part can be converted into a usable implantable sensor 112, wherein the coating 134 has been applied to the electronics portion 118. All surfaces of the implantable sensor 112 facing the user are thus sterilized without damaging the electronic components 128.

The disinfection device 110 prepared in this way according to fig. 1 can thus be delivered to a user, for example. Alternatively, the pulling apart of the encapsulation 114 may also be performed by a user. For example, the user may then open the enclosure 114 and retrieve the implantable sensor 112 for utilization. In this case, the sensor part 120 can be inserted completely or partially into the body tissue, for example with an insertion aid, which is likewise accommodated in the interior space 116, or it can be designed as a separate component and is not shown in fig. 1. The electronics portion 118 may be fully or partially secured to the surface of the user's skin using the second adhesive layer 140, wherein, for example, the cover layer 142 is pulled away and the second adhesive layer 140 is pressed against the skin surface.

As mentioned above, the final assembly of the implantable sensor 112 may be performed during the deformation of the encapsulation 114, which may be designed, for example, as a plastic sheet, in particular as a PE sheet (PE: polyethylene). The encapsulation 114 may preferably remain closed during such deformation, such that the interior space 116 is still protected from recontamination by the encapsulation 114. Alternatively, however, the package 114 may also be torn during deformation of the package 114, and thus, for example, removal of the radiation shield 144 and final assembly of the implantable sensor 112 may be performed during opening of the package 114.

For example, the adhesive layers 136, 140 may be designed as double-sided adhesive films. For example, the second adhesive layer 140 facing the skin surface may be designed as a flexible breathable plaster.

The radiation shield 144 may preferably be made of aluminum. Aluminium represents a good compromise between electron absorption and low bremsstrahlung radiation. However, other materials, such as metallic materials, may also be used. Preferably, a combination of light and heavy metals may be used, particularly preferably a combination of aluminium and lead, for example aluminium facing the radiation source.

In fig. 1, the electronics 118 are shown only symbolically. In particular, the at least one electronic component 128 may also be arranged and/or designed in some other way than that shown in fig. 1. Thus, instead of or in addition to the arrangement shown in fig. 1, one or more electronic components 128 may also be arranged on a side facing the irradiation direction 146, integrated in the substrate 126 and/or arranged on an opposite side of the substrate 126 facing away from the irradiation direction 146. Instead or in addition, it is also possible to embed at least one electronic component 128 in the substrate material completely or partially, for example sealed with synthetic resin, so as to produce a flat surface which can be adhesively bonded or connected in some other way well to the covering 134, in particular the first adhesive layer 136.

In principle, it is also possible to connect the radiation shield 144 to, for example, an adhesive layer and the overlying substrate 126, and to the at least one electronic component 128 before sterilization, for example by encapsulation and/or permanent adhesive bonding. However, such a design would in principle result in an undesirably high profile of the sensor system, since for a typical thickness of 5mm of the radiation shield 144 a large overall height of the electronics part 118 would result for such a design.

In fig. 2, an alternative design of the disinfection device 110 is shown in a representation similar to fig. 1. For the illustrated components, therefore, reference is initially made mostly to the description of fig. 1.

However, in fig. 2, an alternative is shown in which the radiation shield 144 is not housed in the interior space 116 but is outside the interior space 116. Thus, the radiation shield 144 is preferably not an integral part of the package 114, but is formed separately from this package 114. For example, generally for the present exemplary embodiment or in other exemplary embodiments, the radiation shield 144 may nevertheless protrude into the interior space 116 in such a way that it is disposed in the intermediate space between the first portion 130 and the second portion 132 before the implantable sensor 112 is finally assembled. In this way, the radiation shield 144 may be arranged to shield disinfecting radiation, incident from one or more spatial directions and not shown in the figures, from the at least one electronic component 128, while the first portion 130, e.g. the cover 134, is disinfected by the disinfecting radiation.

For example, the radiation shield 144 may protrude into the interior space 116 at least one projection. For example, the encapsulation 114 may have at least one finger 150 protruding into an inner space 116 in the form of a recess into which the radiation shield 144 is inserted and/or placed from the outside and/or into which the radiation shield 144 protrudes. The radiation shield 144 can be easily pulled from the interdigitation 150, particularly the dimple, after radiation sterilization. For example, the radiation shield 144 may be fixedly attached to the manufacturing device. During the assembly of the disinfection device 110 according to fig. 2, the encapsulation 114 can be pushed onto this radiation shield 144, for example with a recess according to the invention or with an interdigital 150 according to the invention, and pulled out again after disinfection. This has the following advantages: the radiation shield 144 may be used repeatedly over and over again.

As described above, the at least one cover layer 138 may also be pulled away from the first adhesive layer 136, such as pulling the protective film, when the radiation shield 144 is pulled out. For this purpose, a connection 148 may instead be provided, which preferably does not directly connect the cover layer 138 to the radiation shield 144, for example, in this case, but rather to an interdigital finger 150, in particular a dimple, into which the radiation shield 144 can be inserted. The finger 150 may be embodied in such a way that when the radiation shield 144 is pulled out, it is pulled out together and turned inside out. The cover layer 138, in particular the protective film, is then also pulled out thereby via the connection 148, so that an adhesive connection between the first part 130 and the second part 132 is possible.

The pulling out of the fingers 150 during the removal of the radiation shield 144 can be made possible by a simple clamping area as schematically shown in fig. 3. Thus, fig. 3 shows an alternative design of the interdigitated 150 region of the package 114. The exemplary embodiment shows that the fingers 150, which may be specifically designed as dimples that protrude into the interior space 116, may have specific clamping areas 152 where the encapsulation 114 is in close proximity to the radiation shield 144. If the radiation shield 144 is pulled from the finger 150 in a direction to the left in fig. 3 and/or if the envelope 114 is pulled from the radiation shield 144 in a direction to the right in fig. 3, the walls of the envelope 114 can securely carry the radiation shield 144 in the clamping region 152, thereby pulling the finger 150 from the interior space 116.

In fig. 4, a third exemplary embodiment of a disinfection device 110 according to the present invention is shown. The disinfection device 110 may initially in turn substantially correspond to the exemplary embodiment according to fig. 1, so that reference may be made to fig. 1 above with respect to most elements of the exemplary embodiment. In the state shown in fig. 4 (which is before and/or during radiation sterilization), the first portion 130 and the second portion 132 of the implantable sensor 112 contained in the package 114 are separated in turn by the radiation shield 144. By using the reasoning of fig. 1, the irradiation can again be performed in fig. 4 such that the first portion 130 is sterilized by the radiation, but the second portion 132 is completely or partially shielded by the radiation shield 144.

Compared to the exemplary embodiment in fig. 1, the exemplary embodiment according to fig. 4 has several modifications, which may be implemented individually or in any desired combination.

Thus, the exemplary embodiment according to FIG. 4 first illustrates that the package 114 may have one or more handles. Thus, in the exemplary embodiment according to fig. 4, a first handle 154 is provided, which is arranged at the right end of the encapsulation 114 and is connected to a first encapsulation part 156 of the encapsulation 114. At one end of the enclosure 114 on the left in fig. 4, another handle 158 is provided which is connected to a second enclosure portion 160 of the enclosure 114. The enclosure portions 156, 160 can be pulled apart, preferably without opening the enclosure 114 thereby, using the handles 154, 158. The implantable sensor 112 is preferably connected to the first encapsulation portion 156 by a pull strip 162, for example, as shown in fig. 4. This pull strip may in principle act on any desired portion of the implantable sensor 112, for example, as shown in fig. 4, on the coating 134. Other designs are also possible.

During radiation sterilization, the implantable sensor 112 is radiation sterilized in the sterilization device 110 according to the configuration shown in fig. 4, for example, in the irradiation direction 146 shown in fig. 1. After radiation sterilization, the package 114 may be widened by grasping the package 114 at the handles 154, 158 and pulling the package portions 156, 160 apart. When this occurs, for example, the radiation shield 144 is pulled out of the intermediate space between the first portion 130 and the second portion 132. To prevent tearing of the enclosure 114, the first enclosure portion 156 and the second enclosure portion 160 may be connected by a bellows 164. However, alternatively or additionally, encapsulation 114 utilizing a flexible encapsulating material, such as a flexible sheet, is also contemplated.

Fig. 4 also shows an exemplary embodiment in which the sensor is finally assembled, connecting the first portion 130 and the second portion 132 to each other, during deformation of the package 114 by pulling the handles 154, 158 apart. For the purpose of this final assembly, the implantable sensor 112, or a portion thereof, may be pulled by a constriction 166 in the package 114. This option is shown in fig. 4. In the present exemplary embodiment, the compression device is formed, for example, by an intermediate space between the wall 168 of the package 114 and the pressure pad 170. Other designs are also contemplated, such as a design having two or more pressure pads 170 and/or a compression device 166 that forms a gap between other elements of the package 114. In the compression device 166, the first part 130 and the second part 132 can be pressed against one another, for example, in order to press the cover 134 onto the substrate 126 of the electronic part 118 and/or onto the electronic component 128, in particular with the first adhesive layer 136. In this way, the strength of the connection of the layered structure thus produced can be significantly increased.

With the design shown in fig. 4, in particular, a sterile, sealed package may be maintained during final assembly of the implantable sensor 112. The provision of handles 154, 158 allows for convenient widening of package 114. As noted above, in addition to the bellows 164 used to expand the enclosure 114, a flexible enclosure or some other type of expandable enclosure may also be used. However, it is preferred that all designs for this kind of package 114 maintain the requirements for a sterile seal during deformation of the package 114 and final assembly of the implantable sensor 112.

Pressure pads 170 integrated into package 114 may gently exert pressure on components of implantable sensor 112, such as on substrate 126, particularly on a flexible printed circuit board. Specifically, in this way, the flexible printed circuit board can be completely electrically contacted and connected by the first adhesive layer 136. Other flexible and/or rigid and/or semi-rigid components may also be used instead of or in addition to the pressure pad 170.

To ensure relative movement between the package 114 and the implantable sensor 112, a pull strip 162 is preferably provided. This pull strip 162 may extend, for example, between the handle 154 and the cladding 134 on the right. Other contact possibilities for this pull strip 162 are also possible. Such a pull strip 162 should preferably be easy to remove. For example, the pull strip 162 may thus act on the cover layer 142 of the second adhesive layer 140, for example on a pull-out protective film. Other designs are also possible. Instead of or in addition to using the pull strip 162, another connection may be made between the packaging 114, and in particular the first packaging part 156, and the implantable sensor 112. Thus, for example, a rigid or partially rigid enclosure 114 may also be selected that is capable of mechanical interaction with the implantable sensor 112, and wherein an expandable region, such as in the form of a bellows 164, is located between where the enclosure 114 is coupled to the implantable sensor 112 and where the radiation shield 144 is connected to the enclosure 114.

One or more additional assembly steps may also be completed within the package 114, wherein final or further assembly of the implantable sensor 112 and/or a sensor system including the implantable sensor 112 is performed, concurrently with pulling the radiation shield 144 open and exposing the first adhesive layer 136. Such a design is shown, for example, in fig. 5. The disinfection device 110 shown therein may initially in turn correspond, for example, to the design according to fig. 4, so that reference may be made to the above description of fig. 4. In principle, however, other designs are also possible.

In the exemplary embodiment shown therein, the interior space 116 of the package 114 contains, in addition to the at least one implantable sensor 112, at least one medical aid, in this exemplary embodiment, at least one insertion aid 172. Instead of or in addition to the insertion aid 172, one or more medical aids designed in some other way may be accommodated in the package 114. For example, the insertion aid 172 may be designed as a slotted sleeve or the insertion aid 172 may take some other form. Thus, it is generally necessary to implant the tip of the implantable sensor 112 so that the sensor portion 120 is completely or partially subcutaneous. As mentioned above, a sleeve, in particular a so-called split sleeve, having a split running along the longitudinal axis of the sleeve may be used as an insertion aid 172. In this case, the insertion aid 172, particularly the split cannula, must generally be sterilized in the same manner as the tip of the implantable sensor 112. It is therefore generally advisable to perform radiation sterilization in combination with the gathering of components within the closed package 114. Suitable embodiments of the package 114 allow this at least one assembly step to be performed by the end user himself. However, as an alternative, this assembly may also be performed in whole or in part by the manufacturer, since in many cases it may be advisable to perform such critical assembly steps during engineering manufacturing. For the exemplary embodiment shown in fig. 5 or all other exemplary embodiments of the present invention, the encapsulation 114 may in particular be of a completely or partially transparent design. This transparent design of the package 114 also provides the opportunity to perform visual inspection of the assembly operation and thereby ensure that possible errors are discovered and removed.

As mentioned above, the encapsulation 114 may in particular be completely or partially manufactured from at least one sheet element. For example, plastic sheets, in particular flexible or stretchable plastic sheets, such as PE sheets and/or PET sheets, can be used for this purpose. Alternatively or additionally, rigid materials may also be used for the encapsulation 114. For example, the components of the package 114 may be designed as injection molded parts and/or injection blow molded parts or by some other means as plastic molded parts. The molded part produced in this way can have, for example, at least one opening through which the sensor 112 can be introduced into the interior 116. For example, the at least one opening may be closed by a membrane and/or connected to a membrane element and/or closed with another enclosing part, such as a plug or screw closure, with a flexible element (e.g. bellows 164). For example, the enclosing parts 156, 160 may be designed wholly or partly as plastic moulded parts, which are connected via bellows 164 and/or by some other designed flexible element.

For example, for the design according to fig. 1, it may be advantageous to design the encapsulation 114 completely as a sheet-like element. For other designs, such as the case in fig. 2-5, it may be advantageous to manufacture the package 114 in a rigid or semi-rigid form, such as a plastic, especially a plastic molded part, such as in an injection molding process or an injection blow molding process. Such a rigid package may have a large opening. The implantable sensor 112 can be placed in position through this opening. The opening may be closed with a suitable membrane that is torn open to expose the opening again after sterilization and final assembly, thus making it possible to remove the sterile implantable sensor 112.

Embodying the package 114 fully or partially as a plastic molded part also generally enables precise positioning of the components and bringing together the sensor portion 120 of the implantable sensor 112 and an insertion aid 172 (e.g., a split sleeve) in an error-free manner. The packaging 114 may also be embodied such that in a first step the above-described assembly or positioning operation is performed, wherein the at least two parts 130, 132 are brought together and the implantable sensor 112 is assembled and/or connected to the insertion aid 172, and in a next step an opening is performed, in preparation for removing the sensor system with the at least one implantable sensor 112 and possibly the insertion aid 172. The two steps may also be combined with each other and performed within a single movement. For example, as described above, the package 114 may include at least one predetermined breaking point. In fig. 5, possible positions of the at least one predetermined breaking point are indicated, for example, by reference numeral 174. Alternatively or additionally, other positions of this predetermined breaking point 174 are also possible.

As shown in fig. 1, radiation sterilization may be performed generally from one irradiation direction 146. However, this need not necessarily be the case, as in principle many irradiation directions may also be used. This is shown, for example, in fig. 6. The exemplary embodiment in fig. 6 initially represents a combination of the exemplary embodiments in fig. 2 and 4, so reference can be made to the above description of these fig. 2 and 4. Thus, the encapsulation 114 may, for example, in turn comprise a pressure pad 170, and at least one deformable region, in particular a bellows 164. Further, the enclosure 114 may include at least one handle 154, in this case, for example, on a first enclosure portion 156. Other designs are also possible.

By using reasoning according to the exemplary embodiment of fig. 2, the implantable sensor 112 in fig. 6 is instead divided into a first part 130 and a second part 132, in particular in the region of the electronic part 118, the parts 130, 132 being radiation sterilized in different ways. Although the first portion 132, including the substrate 126 and the one or more electronic components 128, is shielded by the radiation shield 144, in this case, the second portion 132 is a multi-part design, sterilized by radiation. As a difference from the exemplary embodiment according to fig. 2, wherein preferably the irradiation is performed from only one irradiation direction (not shown in fig. 2, by using the reasoning of fig. 1), whereas in fig. 6 the irradiation is performed from both sides, from the irradiation direction 146 and from the other irradiation direction 176. In the present exemplary embodiment, the implantable sensor 112 can thus be radiation sterilized on both sides. In this case, the radiation shield 144 may be designed in such a way that it shields the second portion 132 from at least two spatial directions, e.g. the radiation shield 144 surrounds the second portion 132, as shown in fig. 6. For example, the radiation shield 144 may be a U-shaped configuration, as shown in FIG. 6, with the second portion 132 of the implantable sensor 112 disposed between the legs of the U during radiation sterilization.

By inference from the design in fig. 1, 4 and 5, in this case, the radiation shield 144 may in turn be disposed wholly or partially within the package 114. However, alternatively or additionally, as shown in fig. 6 and by utilizing the reasoning of fig. 2, the radiation shield 144 may also only protrude into the package 114 and be designed such that it can be separated from the package 114. For example, one or more fingers 150, 186 may be provided in turn for this purpose, which protrude into the interior of the encapsulation 114 into which the radiation shield 144 has been inserted. These fingers 150, 186 may generally be formed as dimples, as shown in fig. 2.

Thus, as shown in FIG. 6, the first portion 130 has a coating 134 with a first adhesive layer 136 that is covered by a coating 138. If, after radiation sterilization, the fingers 150 of the encapsulation 114 arranged between the cover layer 134 and the second part 132 are pulled out of the interior 116, the cover layer 138 can be torn off via the connections 148 and the cover layer 134 can be adhered to the at least one electronic component 128 and/or to the substrate 126.

Furthermore, a further coating 178 can also be applied to the substrate 126, for example from the side facing the further irradiation direction 176 to a flexible printed circuit board. This further coating 178 can be radiation sterilized from the irradiation direction 176, for example in a manner similar to the irradiation direction 146, for example with beta radiation having an energy of 2.5 MeV. For example, the further coating 178 may in turn be provided with a further adhesive layer 180 and a further coating layer 182. On the side facing the further cladding layer 178, the encapsulation 114 may have at least one further interdigital 186 into which the leg of the radiation shield 144 facing the further cladding layer 178 projects in the configuration shown in fig. 6. This further finger 186 can be connected to the further cover layer 182 by means of a further connection 184, so that the protective layers 138, 182 are torn open by means of the connections 148, 184 when the radiation shield 144 is pulled out, and when the fingers 150, 186 are pulled out.

During radiation sterilization, the overlays 134 and 178 are radiation sterilized while the substrate 126 and the at least one electronic component 128 are fully or partially shielded by the radiation shield 144. After radiation sterilization, final assembly of the implantable sensor 112, in which the package 114 is deformed, may be performed by the manufacturer and/or user of the implantable sensor 112. In doing so, the radiation shield 144 may optionally be pulled out of the package 114. However, alternatively or additionally, the radiation shield 144 may also remain fully or partially within the package 114 by inference utilizing the designs in fig. 1, 4, and 5. Furthermore, during deformation of the package 114, final assembly of the implantable sensor 112 may be performed, such as by utilizing the reasoning of the exemplary embodiments described above, and optionally also with an insertion aid 172 not shown in fig. 6, such as by utilizing the reasoning of fig. 5. In turn, during deformation of the package 114 in the final assembly, the implantable sensor 112 may be pulled, for example, by at least one compression device 166 in the package 114, as shown in fig. 6. This in turn may be formed by a pressure pad 170, for example. Other designs of the compression device described above are also possible. For example, a connection may be made between the implantable sensor 112 and the first encapsulation portion 156 in turn for this purpose, for example via a pull strip 162 in turn. The action of pulling the implantable sensor 112 through the compression device 166 allows the overlays 134, 178 to be pressed onto the substrate 126, such as a flexible printed circuit board, from both sides and attached thereto, such as via optional adhesive layers 136, 180. In this manner, the implantable sensor 112 may be manufactured with its outer surface fully radiation sterilized, but radiation damage to the at least one electronic component 128 may still be prevented by the radiation shield 144 during manufacture.

Generally, with the above-described design of the invention and/or with other designs according to the invention, commercially available electronic components can be used as electronic components 128, despite the necessary radiation disinfection with a high-energy beam. The option of removing the radiation shield 144 from the package 114 is provided with further advantages. Thus, for example, the radiation shield 144 no longer has to be delivered to the end customer, which may result in cost savings and a reduction in the amount of product delivered. In particular, the sensor system may have a low profile when used on a patient because the radiation shield 144 is not an integral part of the implantable sensor 112.

Furthermore, the possibility of integrating other medical aids into the package 114 shown in fig. 5 brings about further advantages. Thus, for example, the various components in contact with the skin, such as the sensor part 120, in particular the sensor tip, the insertion aid 172, in particular the split sleeve, and optionally the second adhesive layer 140, can be sterilized together in a package 114 designed as a sterile-sealed outer package, after which they can be assembled together without the need to open the sterile package, for example, because these components are placed in one or more new relative positions within the package 114, in particular by deformation of the package 114.

List of reference numerals:

110 sterilizing device

112 implantable sensor

114 packaging

116 inner space

118 electronic part

120 sensor part

122 sensor electrode

124 substrate

126 substrate

128 electronic component

130 first part

132 second part

134 coating

136 first adhesive layer

138 cover layer

140 second adhesive layer

142 coating

144 radiation shield

146 direction of irradiation

148 connection

150 finger

152 clamping area

154 handle

156 first packaging part

158 handle

160 second package part

162 pulling strip

164 bellows

166 compression device

168 wall

170 pressure pad

172 insertion aid

174 predetermined breaking point

176 direction of irradiation

178 another coating

180 another adhesive layer

182 another cover layer

184 another connection

186 another finger

Claims (15)

1. Method for disinfecting an implantable sensor (112) for sensing at least one analyte in body tissue, wherein the implantable sensor (112) has at least one sensor part (120) which can be introduced into body tissue and has at least one sensor electrode (122) for sensing the analyte and at least one electronics part (118), the electronics part (118) having at least one electronic component (128) and being connected to the sensor part (120), the method comprising the steps of:

a) introducing the implantable sensor (112) into at least one package (114), the package (114) insulating the implantable sensor (112) such that it is sealed against bacteria, and the package (114) containing a radiation shield (144) shielding an electronic portion (118),

b) the implantable sensor (112) is irradiated in the package (114) with sterilizing radiation, in particular with electron radiation, from at least one irradiation direction (146, 176), the radiation shield (144) shielding the electronic components (128) of the electronic part (118) from the sterilizing radiation, the radiation shield (144) being arranged in such a way that the sensor part (120) is sterilized by the sterilizing radiation.

2. The method according to the preceding claim, wherein after performing method step a) the implantable sensor (112) has at least a first portion (130) and at least a second portion (132), the first portion (130) being sterilized in method step b), the second portion (132) being shielded from sterilizing radiation by a radiation shield (144) in method step b), wherein after performing method step b) the first portion (130) and the second portion (132) are connected within the package (114).

3. The method according to the preceding claim, the encapsulation (114) being of deformable design in such a way that the first part (130) and the second part (132) are moved relative to each other when there is deformation of the encapsulation (114) after performing method step b) in such a way that they are connected to each other.

4. Method according to one of the preceding claims, the electronics part (118) having a layered structure with at least one cover layer (134), wherein in method step b) the cover layer (134) is arranged relative to the radiation shield (144) in such a way that the cover layer (134) is at least partially disinfected by disinfecting radiation, wherein after performing method step b) the cover layer (134) is applied to the electronic component (128) within the encapsulation (114), in particular without opening the encapsulation (114).

5. The method according to the preceding claim, the encapsulation (114) being of deformable design in such a way that, when there is deformation of the encapsulation (114), the implantable sensor (112) is moved by at least one compression device (166), the coating (134) being pressed onto the electronic component (128) by the compression device (166).

6. The method of the preceding claim, wherein the radiation shield (144) is separated from the package (114) during deformation of the package (114).

7. Method according to one of the preceding claims, wherein in method step a) additionally at least one medical aid, in particular at least one insertion aid (172), is introduced into the encapsulation (114).

8. Sterilization device (110) for sterilizing an implantable sensor (112) for sensing at least one analyte in body tissue, in particular for use in a method according to one of the preceding claims, the sterilization device (110) comprising:

-at least one implantable sensor (112) for sensing at least one analyte in body tissue, wherein the implantable sensor (112) has at least one sensor portion (120) which can be introduced into body tissue and has at least one sensor electrode (122) for sensing the analyte and at least one electronics portion (118), the electronics portion (118) having at least one electronic component (128) and being connected to the sensor portion (120);

-at least one package (114), the package (114) insulating the implantable sensor (112) such that it is sealed against bacteria, and the package (114) accommodating at least one radiation shield (144) shielding electronic components (128) of the electronic part (118) during radiation sterilization.

9. The disinfection device (110) as claimed in the preceding claim, the sensor (112) having at least a first portion (130) and at least a second portion (132), the first portion (130) being sterilizable in the encapsulation (114) during radiation disinfection, the second portion (132) being shielded by the radiation shield (144) during the radiation disinfection, the first portion (130) and the second portion (132) being connectable within the encapsulation (114) after the radiation disinfection is performed, in particular without opening the encapsulation (114).

10. The disinfection device (110) as claimed in the preceding claim, the encapsulation (114) being of deformable design in such a way that the first part (130) and the second part (132) can be moved relative to one another when there is deformation of the encapsulation (114) after the radiation disinfection has been performed in such a way that they are connected to one another.

11. Sterilization device (110) according to one of the preceding claims relating to a sterilization device (110), the electronics section (118) having a layered structure with at least one coating (134), wherein the encapsulation (114) is designed in such a way that during radiation sterilization the coating (134) is arranged with respect to the radiation shield (144) in such a way that the coating (134) can be at least partially sterilized by means of sterilization radiation, while the electronic components (128) are shielded, the encapsulation (114) being designed in such a way that after radiation sterilization is performed, the coating (134) can be applied to the electronic components (128) within the encapsulation (114), in particular without the need to open the encapsulation (114).

12. The disinfection device (110) as claimed in the preceding claim, the encapsulation (114) being of deformable design in such a way that, when there is a deformation of the encapsulation (114), the implantable sensor (112) is moved, in particular pulled, by at least one compression device (166), by means of which compression device (166) the coating (134) can be pressed onto an electronic component (128).

13. The disinfection device (110) as claimed in the preceding claim, wherein the radiation shield (144) is detachable from the encapsulation (114) during deformation of the encapsulation (114).

14. The disinfection device (110) as claimed in one of the two preceding claims, wherein a radiation shield (144) has been inserted from outside into at least one finger (150) of the encapsulation (114) which projects into the interior space (116) of the encapsulation (114) prior to the deformation of the encapsulation (114).

15. Sterilisation apparatus according to one of the three preceding claims, the encapsulation (114) being of deformable design in such a way that the implantable sensor (112) is connected to a first encapsulation portion (156) of the encapsulation (114), the radiation shield (144) being movable together with a second encapsulation portion (160) of the encapsulation (114), the first encapsulation portion (156) and the second encapsulation portion (160) remaining connected to each other during deformation of the encapsulation (114) in such a way as to ensure a sterile, sealed shielding of the implantable sensor (112).