Abstract: This disclosure concerns a medical device and a method for its production, wherein the device comprises a cannula having an elongated hollow shaft and a sharp tip provided at a distal end of the shaft, wherein the shaft is formed as a bent part from a sheet material and confines an interior passage which has a lateral slit opening, and wherein the shaft has at least one longitudinal pre-bending channel provided in the sheet material, wherein the thickness of the sheet material is reduced along the pre-bending channel and a sidewall of the shaft is folded over the pre-bending channel.

Abstract: A sensor (110), a sensor assembly (256) for detecting at least one analyte in a body fluid and methods of manufacturing a sensor (110) and a sensor assembly (256) for detecting at least one analyte in a body fluid are disclosed. The sensor (110) has at least one substrate (114). The sensor (110) further has at least two electrodes (116) applied to the substrate (114), wherein the electrodes (116) are adapted for detecting the analyte. The sensor (110) further has at least two contact pads (118) applied to the substrate (114) and at least two electrical traces (120) applied to the substrate (114). The electrical traces (120) electrically connect the electrodes (116) and the contact pads (118). The sensor (110) further comprises a sealing ring (134) fixedly applied to the substrate (114). The sealing ring (134) surrounds the contact pads (118).

Abstract: Protective coverings are provided for hand-held medical devices that have a measuring port for a disposable analytical test element. The coverings also include a sleeve having a reception opening and can be slipped over the devices to at least partially enclose the devices in a usable protected state. The coverings further include a test element adapter formed as an integral part of the sleeve to receive the test element in alignment with a measuring port, where the sleeve includes the test element adapter and is arranged as a sealing barrier between the test element and the device port in a protected state.

Abstract: A method and an apparatus are described for the generation of microparticles containing an immobilized functional component, where the following measures are proposed: spraying a liquid (32) containing a soluble alginate and a functional component consisting of molecules or nanoparticles to generate a stream (60) of droplets, directing the stream (60) of droplets onto a precipitation bath (16) and capturing the droplets therein by application of high voltage (14), precipitating the droplets in the precipitation bath (16) via a precipitation liquid (18) containing an alginate complexing agent, such that the droplets are solidified to form microparticles (10) containing the functional component and extracting the microparticles (10) from the precipitation bath (16).

Abstract: A sensor assembly for detecting at least one analyte in a body fluid includes an electrochemical sensor, a body mount that attaches to a body of a user and an inserter that transfers the sensor to the body mount. A first adhesive is attached to one or both of the body mount or the sensor, and the first adhesive attaches the sensor to the body mount. A second adhesive is attached to one or both of the sensor or the inserter and releasably attaches the sensor to the inserter. The assembly has an initial position in which the sensor is attached to the inserter via the second adhesive and a final position in which the sensor is attached to the body mount via the first adhesive. Transferring the sensor from the initial position to the final position releases the sensor from the inserter.

Abstract: A sensor assembly (256) for detecting at least one analyte in a body fluid and a method of assembly a sensor assembly (256) for detecting at least one analyte in a body fluid are disclosed. The sensor assembly (256) comprises: at least one body mount (212) configured for attachment to a body of a user; at least one electronics unit (186) attachable to the body mount (212), having at least one electronics component (208) for one or more of controlling the detection of the analyte or transmitting measurement data to another component; wherein the body mount (212) includes a locking mechanism (216) having at least one lever (218) pivotably mounted to the body mount (212), the lever (218) being configured to lock the electronics unit (186) to the body mount (212).

Abstract: Disclosed is an inventive method for an aseptic assembly of a multi-component medical device. In this method a first component of the medical device is provided in a first container and a second component of the medical device is provided in a second container. Each of the first and second separated containers have a rupturable portion. The first component in the first container is sterilized using a first sterilization technique and the second component in the second container is sterilized using a second sterilization technique. The first and second containers are joined while arranging the rupturable portions in an overlapping configuration which is aseptically sealed against the surroundings. Finally, one of the components is transferred through the rupturable portions and the components are aseptically assembled to form the medical device as a sterile package.

Abstract: The application relates to a method for producing a sterilized subcutaneous access device, the method comprising: producing a device carrier unit, comprising providing a carrier, producing a subcutaneous access part on the carrier, the subcutaneous access part being provided with at least one of a sensor device for detecting an analyte present in a bodily fluid and an infusion device for infusion of a substance, and producing an electronic assembly on the carrier, the producing comprising printing a battery on a carrier material, and sterilizing the device carrier unit by radiation sterilization, the sterilizing comprising exposing the printed battery to the radiation applied for sterilization. Furthermore, the application relates to a sterilized subcutaneous access device.

Abstract: A lancet magazine is disclosed which includes a housing and a plurality of lancets each of which is enclosed in a sterile chamber of the housing, wherein the chambers each have a puncturing opening which is closed with a foil, wherein the lancets include a sample receiving device for receiving body fluid and the chambers each include a further opening which is closed with a membrane that is permeable to gas and fluid and includes a lower side that faces the lancet and serves to receive body fluid from the sample receiving device and an upper side that serves to transfer body fluid to a test field arranged on the membrane.

Abstract: Sensor elements are disclosed for the electrochemically analyzing a body fluid, as well as methods of producing and using the same. The sensor elements include an electrically conductive layer structure applied to a non-conductive carrier substrate, where the layer structure includes a continuous base layer of tantalum, niobium or an alloy thereof, and a metallic cover layer formed on the base layer that covers the base layer either over the entire surface or in some regions. The metallic cover layer includes a more noble metal when compared to the base layer.

Abstract: A sensor assembly (256) for detecting at least one analyte in a body fluid and a method of assembly a sensor assembly (256) for detecting at least one analyte in a body fluid are disclosed. The sensor assembly (256) comprises: at least one body mount (212) configured for attachment to a body of a user; at least one electronics unit (186) attachable to the body mount (212), having at least one electronics component (208) for one or more of controlling the detection of the analyte or transmitting measurement data to another component; wherein the body mount (212) includes a locking mechanism (216) having at least one lever (218) pivotably mounted to the body mount (212), the lever (218) being configured to lock the electronics unit (186) to the body mount (212).

Abstract: This disclosure concerns a medical device and a method for its production, wherein the device comprises a cannula having an elongated hollow shaft and a sharp tip provided at a distal end of the shaft, wherein the shaft is formed as a bent part from a sheet material and confines an interior passage which has a lateral slit opening, and wherein the shaft has at least one longitudinal pre-bending channel provided in the sheet material, wherein the thickness of the sheet material is reduced along the pre-bending channel and a sidewall of the shaft is folded over the pre-bending channel.

Abstract: This disclosure relates to an analytic test unit for use in a test device for detecting an analyte in a bodily fluid, having at least one test element with a carrier film and a reagent layer, the latter being affixed on the carrier side of the carrier film and it being possible to apply bodily fluid on said reagent layer, wherein the light-transparent carrier film can be positioned in the beam path of a photometric measuring unit for optically scanning the reagent layer. According to this disclosure, it is proposed that the carrier film has a surface, modified by a raised surface structure, for reducing reflections in the beam path of the measuring unit.

Abstract: A sensor (110), a sensor assembly (256) for detecting at least one analyte in a body fluid and methods of manufacturing a sensor (110) and a sensor assembly (256) for detecting at least one analyte in a body fluid are disclosed. The sensor (110) has at least one substrate (114). The sensor (110) further has at least two electrodes (116) applied to the substrate (114), wherein the electrodes (116) are adapted for detecting the analyte. The sensor (110) further has at least two contact pads (118) applied to the substrate (114) and at least two electrical traces (120) applied to the substrate (114). The electrical traces (120) electrically connect the electrodes (116) and the contact pads (118). The sensor (110) further comprises a sealing ring (134) fixedly applied to the substrate (114). The sealing ring (134) surrounds the contact pads (118).

Abstract: A method for manufacturing a device for monitoring at least one body function of a user comprising providing an evaluation unit, providing a sensor unit, aligning a connector portion of the sensor unit next to an electric contact pad of the evaluation unit such that the connector portion faces the electric contact pad, providing at least one anisotropic conductive adhesive between the electric contact pad and the connector portion, and bonding the evaluation unit substrate and the connector substrate together, wherein the electric contact pad and the connector portion are pressed together, and wherein an electric connection of the electric contact pad and the connector portion is created via the anisotropic conductive adhesive.

Abstract: A sensor assembly for detecting at least one analyte in a body fluid includes an electrochemical sensor, a body mount that attaches to a body of a user and an inserter that transfers the sensor to the body mount. A first adhesive is attached to one or both of the body mount or the sensor, and the first adhesive attaches the sensor to the body mount. A second adhesive is attached to one or both of the sensor or the inserter and releasably attaches the sensor to the inserter. The assembly has an initial position in which the sensor is attached to the inserter via the second adhesive and a final position in which the sensor is attached to the body mount via the first adhesive. Transferring the sensor from the initial position to the final position releases the sensor from the inserter.

Abstract: Disclosed is an inventive method for an aseptic assembly of a multi-component medical device. In this method a first component of the medical device is provided in a first container and a second component of the medical device is provided in a second container. Each of the first and second separated containers have a rupturable portion. The first component in the first container is sterilized using a first sterilization technique and the second component in the second container is sterilized using a second sterilization technique. The first and second containers are joined while arranging the rupturable portions in an overlapping configuration which is aseptically sealed against the surroundings. Finally, one of the components is transferred through the rupturable portions and the components are aseptically assembled to form the medical device as a sterile package.

Abstract: A method for producing a membrane ring or test strip ring for a diagnostic test device includes an elongate strip that is divided into segments by cuts running transversely to the longitudinal direction of the strip, where the cuts are made only as far as a residual width of the strip so that a material bridge remains intact between the segments adjacent to the cuts (24). The strip is closed by bringing its ends together to form a ring where the cut edges of the cuts running towards the material bridges each enclose an acute angle (?). The ring is inserted into a support structure as a membrane ring or test strip ring for the test device.

Abstract: The invention concerns a method and an apparatus for generation of micropartides containing an immobilized functional component, where the following measures are proposed: —spraying a liquid (32) containing a soluble alginate and a functional component consisting of molecules or nanoparticles to generate a stream (60) of droplets, —directing the stream (60) of droplets onto a precipitation bath (16) and capturing the droplets therein by application of high voltage (14), —precipitating the droplets in the precipitation bath (16) by means of a precipitation liquid (18) containing an alginate complexing agent, such that the droplets are solidified to form micropartides (10) containing the functional component and —extracting the micropartides (10) from the precipitation bath (16).

Abstract: The application relates to a method for producing a sterilized subcutaneous access device, the method comprising: producing a device carrier unit, comprising providing a carrier, producing a subcutaneous access part on the carrier, the subcutaneous access part being provided with at least one of a sensor device for detecting an analyte present in a bodily fluid and an infusion device for infusion of a substance, and producing an electronic assembly on the carrier, the producing comprising printing a battery on a carrier material, and sterilizing the device carrier unit by radiation sterilization, the sterilizing comprising exposing the printed battery to the radiation applied for sterilization. Furthermore, the application relates to a sterilized subcutaneous access device.