Abstract: An assembly for an injection or infusion device includes i) a cartridge being closed by a septum and the surface of the septum being sterile and covered by a first continuous flexible strip, and ii) a fluid path unit comprising a cartridge holder and a fluid path compartment comprising a needle in an interior, the needle is configured to penetrate the septum of the cartridge through a passage in the fluid path compartment. The passage is closed by a second continuous flexible strip keeping the interior of the fluid path compartment in a sterile condition. The cartridge is inserted into the cartridge holder aligning the septum with the passage and sandwiching both strips between the septum and the fluid path compartment. Both strips may be simultaneously removable from the cartridge and fluid path compartment thereby, establishing a sterile connection between the septum and the interior of the fluid path compartment.

Abstract: The present disclosure relates to systems and methods for controlling physiological glucose concentrations in a patient.

Abstract: Monitoring an injection process executed by a variable dose injection device with feedback means for generating a number of feedback events proportionate to the dose to be determined is disclosed. A dialed or injected dose is determined by measuring a first signal of the process comprising a first signal peak related to a feedback event; detecting the first signal peak in the first signal; selecting an evaluation interval comprising the detected peak and adapted to an expected peak duration; deriving, from the first signal limited to the evaluation interval, a feature or characterizing parameter of the feedback event; identifying, from the derived feature, the feedback event as one of a dial up, dial down, or expel feedback event, and counting identified feedback events to determine the dialed or the ejected dose. The two-stage approach with serially executed peak detection and peak identification allows to optimize data storage and processing power.

Abstract: An injection device for dispensing a product, the injection device including a moveable element which is moved for a dispensing operation, a spring, a product container holder and a product container, wherein the spring pushes against the moveable element to move the moveable element to an initial position after the dispensing operation has ended and against the product container to seat the product container in the product container holder.

Abstract: A space-saving, autonomous power supply enables a monitoring unit to monitor a minimum number of delivery events of a drug delivery device. The monitoring unit has delivery status sensing means for monitoring a device delivery status, a status indicator with an indicator element such as an LED controllable to indicate delivery or module status to a user, and a power supply supplying power to the status sensing means and status indicator of the monitoring unit. The power supply has a peak current source, in particular a rechargeable battery or accumulator, providing a load current for operating the status sensing means and status indicator of the monitoring unit. The power supply has a recharge circuit with a converter and a charging resistor for providing a limited recharge current to the peak current source, plus a recharge source for repeatedly providing an optimized recharge source current to the recharge circuit.

Abstract: In an elongated casing, an active agent container connected to an injection needle can be shifted axially by a spring force. Auto-injectors distributed pre-filled and with the springs tensed may be provided with a needle protecting cap to ensure sterility of the needle. When the needle protecting cap is removed as preparation for using the auto-injector, a tensile force can be exerted on the active agent container. Therefore, the active agent container and needle must be prevented from being undesirably pulled forwards. At least one latching tongue prevents the active agent container from being prematurely shifted with respect to the casing, by abutting a flange arranged on a sliding sleeve accommodating the active agent container. When the auto-injector is placed onto the skin, a needle protecting tube is shifted into the casing, forcing the latching tongue away from the flange, thereby freeing the travel path for needle movement.

Abstract: The disclosure is concerned with privacy and integrity of personalized protected health information when transmitted to a cloud computing facility and subsequently distributed to a plurality of stakeholders. An electronic unit of a drug delivery device is configured to prepare payload data comprising data items according to an allocation scheme, and to encrypt, based on an encryption key, and transmit data including the payload data. The allocation scheme and the encryption key are defined for each of a plurality of data subscribers. Accordingly, personalized protected health information payload data is suitably protected with generator-to-subscriber or pass-through data security measures, and any intermediary node or data server in the communication network lacking a matching decryption key will not have access to unencrypted payload data.

Abstract: Injection devices include a cap for removing a needle shield cap from a product container, and methods for assembling such injection devices, involve providing a cap that includes an engagement element for use in removing the needle shield cap from the product container when the cap is removed from the injection device.

Abstract: An injection device configured for attachment to the skin of a patient includes a housing and a skin adhesive layer attached to an external surface of the housing for attaching the injection device to the skin of a patient. A release liner covering the skin adhesive layer prevents the injection device from attaching to the skin. A film with one end connected to a surface inside of the housing forms a removable sterile barrier and the other end connected to an external surface of the release liner without contacting the skin adhesive layer. The housing, skin adhesive layer and release liner each include a notch defining a passage for the film so that the second end of the film can extend from the interior to the exterior of the housing.

Abstract: The invention relates to a detachable needle protection cap for injection devices and to a method for producing same. The detachable needle protection cap comprises a housing and at least two shell parts which can be attached to an outer surface of the housing, the shell parts being fastened to an outer surface of the housing. The shell parts can mutually prevent removal of the shell parts.

Abstract: An injection device comprising a cap for removing a needle protection cap from a product container, and a method for assembling an injection device. The cap comprises an engaging element for removing the needle protection cap from the product container when the cap is removed from the injection device. The engaging element can be deformed in such a way that the engaging element can be moved from a distanced position, in which the engaging element is radially distanced from the needle protection cap, into an engagement position, in which the engaging element engages with the needle protection cap, with the engaging element being deformed when the cap is removed.

Abstract: Dosing device for an administration device with a limiting mechanism containing: a dosing sleeve with a first stop and a stop wheel with a second stop means adapted to continually and proportionally follow a movement of the dosing sleeve during dosing movements. During an ejection movement, there is no relative movement between dosing sleeve and stop wheel. The first stop and the second stop each describe a path curve by their movements such that the two path curves intersect in one point and the stops contact one another and tilt the stop wheel, thereby blocking the dosing movement of the dosing sleeve. The stop wheel comprises first and third sloped surfaces that may form first and second gear guidances with a clutch thereby returning the stop wheel to a non-tilted position during up or down dosing movements when the stops do not contact another.

Abstract: A flexible and reliable delivery state estimator or evaluator is provided for a drug delivery device. The proposed delivery status estimation architecture includes a position sensor that provides a continuous position sensor signal indicative of a current position of a component of the delivery device movable continuously from a first to a second component position, as well as a position discriminator that redefines the continuous position sensor signal to generate an approximate binary input signal on behalf of a state estimator. The discriminator absorbs any difficulty that may arise from a limited reproducibility or enhanced variability of the original continuous sensor signal, specifically including a user-originated signal spread in a movement of a needle protection sleeve of the delivery device.

Abstract: An injection device configured for attachment to the skin of a patient using an adhesive layer includes a release liner covering the adhesive layer thereby preventing skin attachment. The release liner comprises a sheet of material where a first surface contacts the adhesive layer, and an aperture defining a passage for a film connected to a first sterile barrier film located within the injection device. An end of the film is connected to a second surface of the sheet of material that is opposite to the first surface, and the release liner is covered by a strengthening sheet connected to the second surface and covering the aperture and the end of the film.

Abstract: A patch delivery device includes a bottom housing part, a delivery element for subcutaneous delivery of a liquid to a patient, an adhesive patch for attaching the bottom housing part to the skin of the patient, a capacitive sensor with an electrode configuration including a plurality of skin contact sensitive electrodes, and a release liner covering a patient-side adhesive layer of the adhesive patch prior to adhering to the patient's skin. The release liner includes an electrically conductive area extending over at least a portion of the electrode configuration of the capacitive sensor before being removed from the adhesive patch. Providing the release liner with a conductive area gives rise to a discernible change in capacitive response of the sensor electrodes upon release liner removal that enables sensing a removal of a release liner covering a patient-side adhesive layer prior to attachment to the skin of a patient.

Abstract: Implementations relate to a method for establishing an end-to-end encrypted data communication link between a portable medical apparatus and a data-management device. The method comprises at least the following steps: out-of-band transmission of a public key from the medical apparatus to the data-management device, wherein the transmission does not take place via Bluetooth; setting up an encrypted Bluetooth data communication link between the medical apparatus and the data-management device; transmitting a public key from the data-management device to the medical apparatus via the Bluetooth link that has been set up; calculating a combined key on the data-management device and on the medical apparatus; setting up an end-to-end encrypted link between the medical apparatus and the data-management device using the combined key, such as a symmetrical, key.

Abstract: A dosing device for an injection device, the dosing device including an actuating element for adjusting and/or dispensing a dose from the injection device, a thrust element for generating a forward movement for discharging a dose and a coupling to which the actuating element and the thrust element are coupled such that a rotational movement of the actuating element is transmitted directly to the thrust element and an axial movement of the actuating element is different than an axial movement of the thrust element.

Abstract: An infusion apparatus for delivering medication includes a housing, a drive mechanism, a force sensor, and a transfer element. The drive mechanism comprises first and second conveying elements, the second conveying element for advancing a plug in a reservoir in the distal direction, the first conveying element with limited axial movement relative to the housing but rotatable to cause an ejecting or resetting movement of the second conveying element. The force sensor is arranged along a central axis between the housing and the proximal end of the drive mechanism. The transfer element is axially arranged between the force sensor and the first conveying element and the force sensor bears axial forces exerted by the ejection movement. The second conveying element moves the transfer element away from the first conveying element against the bias of a restoring force such that the force sensor bears axial forces exerted by the resetting movement.