Abstract: A dosing unit for an infusion pump device is disclosed having a piston pump with a pump cylinder and a plunger arranged within said cylinder, coaxially arranged along a longitudinal axis. The plunger has a shaft with a thread and the cylinder has a threaded sleeve part with a thread. The two threads engaging with each other in such a way that a rotational movement of the plunger around the longitudinal axis results in an additional linear displacement of the plunger along said longitudinal axis. A separate bias force element biases the two threads in regard to each other along the longitudinal axis, such that the threaded engagement of inner thread and outer thread is free of play independent of a direction of a rotational movement and linear displacement of the plunger in regard to the cylinder.

Abstract: An ambulatory infusion device for the infusion of a liquid drug into a patient's body over an extended time period includes an infusion cannula designed to be placed in the patient's subcutaneous tissue. At least two subcutaneous electrodes are comprised by the infusion cannula and are placed in the subcutaneous tissue. An impedance measuring unit is operatively coupled to the at least two electrodes and is configured to measure at least one impedance value between the at least two electrodes. A variation of the at least one impedance value reflects a displacement of interstitial fluid by drug upon drug administration. An event trigger unit is operatively coupled to the impedance measuring unit and being configured to evaluate the at least one impedance value and to generate an event trigger if evaluation of the at least one impedance value indicates the occurrence of an administration anomaly.

Abstract: A dosing unit for an ambulatory infusion pump device is presented. The dosing unit comprises a cylinder pump with a cylinder and a piston arranged in the cylinder. The piston has a shaft with a first threaded segment interacting with a threaded portion of the cylinder and can be displaced along a longitudinal axis of the cylinder by rotating the piston in regard to the cylinder around the axis. Furthermore, the piston allows for the relative or absolute determination of the longitudinal and/or rotational displacement of the piston in regard to the cylinder. In one embodiment, the piston shaft comprises a second segment provided with optically detectable markings that allow the monitoring of the longitudinal and/or rotational displacement of the piston in regard to the cylinder.

Abstract: A dosing unit for an infusion pump device is disclosed having a piston pump with a pump cylinder and a plunger arranged within said cylinder, coaxially arranged along a longitudinal axis. The plunger has a shaft with a thread and the cylinder has a threaded sleeve part with a thread. The two threads engaging with each other in such a way that a rotational movement of the plunger around the longitudinal axis results in an additional linear displacement of the plunger along said longitudinal axis. A separate bias force element biases the two threads in regard to each other along the longitudinal axis, such that the threaded engagement of inner thread and outer thread is free of play independent of a direction of a rotational movement and linear displacement of the plunger in regard to the cylinder.

Abstract: According to one embodiment, a cannula assembly may include a cannula module and an inserter module. In the pre-operational state the cannula is retracted with respect to the skin-contacting surface. In operational state the cannula projects beyond the skin-contacting surface. The inserter module may include an energy store and an activation mechanism. When the energy store is at least partially discharged, the stored potential energy is transformed to kinetic energy that moves the cannula from the pre-operational state to the operational state. The activation mechanism is triggerable from outside the cannula assembly with a trigger device. The activation mechanism prevents the energy store from being discharged before it is triggered by the trigger device, and enables the energy store to be discharged after it is triggered by the trigger device to force the cannula from the pre-operational state into the operational state.

Abstract: An infusion pump device comprising a primary liquid medicament reservoir, a pump with a secondary reservoir to retrieve medicament from the primary reservoir and to subsequently dose the medicament from the secondary reservoir in adjustable volumes (Vdose,i) to a downstream conduit and a control unit to control the operation of the infusion pump device is presented. For metering the volumes (Vdose,i), the control unit causes the infusion pump device to: (a) determine a maximum refill level (VC,max) for the secondary reservoir, based on external parameters, wherein the maximum refill level does not exceed the maximum capacity of the secondary reservoir; (b) fill the secondary reservoir with medicament from the primary reservoir to the maximum refill level (VC,max); (c) meter and convey the medicament volumes to the downstream conduit; (d) if the secondary reservoir becomes empty, refill the secondary reservoir as in step (b) and continue with step (c).

Abstract: An ambulatory infusion device comprising a replaceable energy storage for electrically powering its functional units is presented. Control units provide to a monitoring system data about energy consuming activities or consumed energy by the functional units. Based on this data, the monitoring system determines energy consumed by the functional units and triggers measurement of the voltage of the energy storage at a point in time which depends on the determined energy consumed in a time interval preceding the point in time. Adapting the time of measurement to the actual energy drawn from the energy storage makes it possible to detect reliably and early a low energy state of any conventional standard battery, regardless of its electrochemical design and electrical behavior.

Abstract: A device for filling a flexible container and a method thereof are disclosed. The device may include a pressurizing chamber and an evacuation chamber. A first displacement piston is sealingly and slideably arranged within the pressurizing chamber to define an inner volume within the pressurizing chamber that is fluidly connected to a pressurizing conduit. A second displacement piston is sealingly and slideably arranged within the evacuation chamber to define an inner volume within the evacuation chamber that is fluidly connected to an evacuation conduit. A reservoir adapter is fluidly connected to the pressurizing conduit and connects to a liquid reservoir. A container adapter is fluidly connected to the evacuation conduit and connects with a flexible container. A transfer conduit is fluidly connected to the reservoir adapter and the container adapter. A valve fluidly connects the container adapter to the evacuation conduit or the transfer conduit.

Abstract: An inserter and methods of using embodiments of the inserter are described. The inserter includes a housing having a cannula assembly and an insertion mechanism. Two buttons are located on the inserter and are concomitantly actionable for actuation of the insertion mechanism, wherein the insertion mechanism is configured to place a cannula assembly in a well that is disposed on the cradle. The inserter also includes a first parts and second part, whereby the first part includes a handle and the second part comprises the entire insertion mechanism, whereby the first and second part are connected via an indentation.

Abstract: An arrangement for introducing a liquid into the body of a patient or for withdrawing a liquid from the body of a patient, including a first structural part carrying a cannula for positioning in the body of the patient, and a second structural part with a connection port for detachably coupling a conduit for supplying or withdrawing a liquid, wherein the first and second structural parts are connected, can be rotated relative to each another and in relative rotational positions form a channel for introducing a liquid from the conduit to the cannula or for withdrawing a liquid from the cannula to the conduit, and whereby movement of the conduit for coupling and uncoupling is transverse to the longitudinal axis of the cannula.

Abstract: An ambulatory medical device is presented. The ambulatory medical device comprises a function module to provide the intended functionality of the device, a controller module to control the device, a sound generation module with an acoustic transducer to produce an acoustic signal and a signal generator to drive the acoustic transducer with a certain frequency. The signal generation module is arranged within a housing of the device. A tuning module varies the frequency used by the signal generator to drive the acoustic transducer and determines one or more frequencies that correspond to an optimum sound level of the acoustic signal outside of the housing of the device. The optimum sound level of the acoustic signal is a maximum sound level outside of the housing of the device, and/or a maximum perceivable sound level as determined by a user.

Abstract: Cannula assemblies with pressure sensors made of stacked coplanar layers and ambulatory infusion systems comprising the same are disclosed. The cannula assemblies include a hub and an infusion cannula. The hub includes a pressure sensor and a fluid channel fluidly coupled to the infusion cannula. The pressure sensor is formed from a stack of coplanar layers including a top layer, a base layer an electrode layer and a counter electrode layer. The fluid channel is positioned between the top layer and the base layer. The electrode layer is positioned between the top layer and the base layer and coupled to the fluid channel. The counter-electrode layer is positioned between the top layer and the electrode layer. A spacer layer having a through cut-out defining an electrode cavity is disposed between the top layer and the base layer such that the electrode layer extends across the electrode cavity.

Abstract: A sensor device for use in a medical fluid delivery system, or an infusion pump device, comprises a fluidic chamber with a deformable cover closing at least an area of the chamber and an optical detection system comprising at least one light emitter for emitting one or more incident light beams and a sensor unit for monitoring one or more reflected light beams is presented. In a pressurized state of the fluidic chamber, the deformable cover is deformed such that it forms an inflexion point area within the deformed cover. The one or more incident light beams emitted by the light emitter are directed on the cover such that the one or more incident light beams are reflected essentially in the inflexion point area.

Abstract: A diabetes therapy device is disclosed herein, which includes a profile memory storing a parameter profile and a dedicated reference time mark. The parameter profile defines at least one parameter that is associated with insulin administration as a function of time for a generally circadian chronobiological cycle. The reference time mark indicates the beginning of the circadian chronobiological cycle and initializes a running time. Insulin amounts to be administered are determined as a function of the running time in accordance with a current matching of the parameter profile. A modified matching based on the reference time mark and an upcoming trigger time is computed and is time-shifted from the current matching, wherein the modified matching is applied by making the modified matching the current matching, such that future insulin amounts to be administered are determined in accordance with the modified matching.

Abstract: An ambulatory infusion device for infusion of a liquid drug into a patient's body over an extended period of time and methods thereof are disclosed. The device includes a sensor assembly, which produces a sensor assembly output based on an infusion characteristic of the ambulatory infusion device and based on a supply voltage/current, and a supply unit which is coupled to a sensor of the sensor assembly and generates the supply voltage/current. A sensor testing unit detects a failure of the sensor assembly, wherein the sensor testing unit is coupled to the sensor assembly and the supply unit, and the sensor testing unit carries out a sensor testing sequence. The sensor testing sequence includes controlling the supply unit so as to produce a variation of the supply voltage/current, and determining whether the variation of the supply voltage/current produces a corresponding variation of the sensor assembly output.

Abstract: An arrangement for introducing a liquid into the body of a patient or for withdrawing a liquid from the body of a patient, including a first structural part carrying a cannula for positioning in the body of the patient, and a second structural part with a connection port for detachably coupling a conduit for supplying or withdrawing a liquid, wherein the first and second structural parts are connected, can be rotated relative to each another and in relative rotational positions form a channel for introducing a liquid from the conduit to the cannula or for withdrawing a liquid from the cannula to the conduit, and whereby movement of the conduit for coupling and uncoupling is transverse to the longitudinal axis of the cannula.

Abstract: A modular infusion pump for administering a product, including a pump housing, a reservoir to contain the product, a delivery device associated with the pump housing to deliver the product from the reservoir, an energy source for the delivery device, another housing separate from the pump housing for receiving the energy source, and a transmission for transmitting energy from the energy source to the delivery device.

Abstract: Embodiments directed to a degassing device for removing gas bubbles from a liquid drug stream and an ambulatory infusion system are disclosed. The degassing device may comprise an inlet chamber with an inlet opening, an outlet chamber with an outlet opening, and a degassing opening. A hydrophilic membrane and a hydrophobic membrane, wherein the hydrophilic membrane fluidically couples the inlet chamber with the outlet chamber, enabling a transfer of liquid from the inlet chamber to the outlet chamber. The hydrophobic membrane fluidically couples the inlet chamber with the degassing opening, enabling a transfer of gas from the inlet chamber to the degassing opening. The hydrophilic and hydrophobic membranes being joined along a joint to establish a joined membrane, such that a contact line of a liquid-gas phase separation on the joined membrane does not coincide with the joint independent of an orientation of the degassing device with respect to gravity.

Abstract: Ampoules for dispensing flowable substances and metering systems incorporating the same are described herein. An ampoule for a flowable substance includes an ampoule body comprising an interior space for receiving the flowable substance and an inner circumferential surface having a guide region and a sealing region. A piston may be disposed in the interior space of the ampoule body such that the piston is slidably displaceable along a direction of displacement. The piston includes at least one sealing element for forming a seal with the inner circumferential surface in a contact zone on the outer circumference of the sealing element. The sealing element has a first compression state when the contact zone is in the guide region and a second compression state when the contact zone is in the sealing region. A second blocking device prevents movement of the contact zone from the sealing region to the guide region.

Abstract: A dosing unit for an ambulatory infusion device and a method of operation are disclosed. The dosing unit includes a stationary member, a movable member, and a plunger. The movable member and the stationary member, together, make a charging valve and a discharging valve. The plunger is located, at least in part, in a metering cavity of the movable member and the movable member is adapted to selectively couple and decouple a driving unit, such that, by operating the driving unit with the movable member being coupled with the driving unit, the movable member moves with the plunger to maintain a position of the plunger relative to the movable member along a displacement axis, and by operating the driving unit with the movable member being decoupled from the driving unit, the plunger is displaced while the position of the movable member is maintained.