Abstract: A method for managing refilling a first reservoir of an ambulatory infusion system from a first container that stores a first drug and for managing refilling a second reservoir of the ambulatory infusion system out of a second container that stores a second drug is disclosed. The method includes repeatedly and automatically carrying out a filling volume assessment routine, which involves determining the expected infusion of the first drug and the second drug between the present time tp and the end of an estimation time interval tf and determining if the first reservoir shall be refilled and/or if the second reservoir shall be refilled at tp based on the expected infusion of the first drug and the second drug determined in step (a). Ambulatory infusion device control units and ambulatory infusion devices that are configured for carrying out such method are also disclosed.

Abstract: An insertion device includes an insertion component that inserts a medical device into body tissue of a user. The insertion device also includes an insertion component retractor, a cap, a guide sleeve having a ramp, an insertion sleeve and an elastic member. For inserting the medical device, the cap, the insertion component retractor and the insertion sleeve are movable relative to the guide sleeve from a distal position to a proximal position. The ramp twists the insertion component retractor relative to the guide sleeve and the insertion sleeve when the cap is moved from its distal position to its proximal position. The cap is movable from its proximal position to its distal position and the insertion component retractor is thereby moved from its proximal position to its distal position. An associated method of using the insertion device is also disclosed.

Abstract: An ambulatory medical device for attachment to a person's body includes a housing having a wall and a vibrator coupler. A convex outer surface of the vibrator coupler projects from the wall towards the outside of the housing. The vibrator coupler is coupled to the wall via a connector arranged along the circumference of the vibrator coupler. A vibrator mechanically vibrates upon activation. The vibrator is arranged at least partially inside a volume defined by the vibrator coupler and is mounted to the vibrator coupler. A skin attachment device is also disclosed. It has a substantially planar body having a skin attachment side and an opposing medical device mounting side. The skin attachment side includes a skin attachment structure for releasably attaching the skin attachment device to a person's skin and the medical device mounting side includes a medical device mount for releasably engaging with the ambulatory medical device.

Abstract: An insertion system comprises a medical device and an insertion device for inserting the medical device into a body tissue of a user, the insertion device comprising: an insertion component-configured for inserting the medical device into the body tissue; an insertion component retractor; a cap; a guide sleeve and an insertion sleeve guided therein; a locking sleeve in the insertion sleeve; and an elastic member positioned between the locking sleeve and the insertion component retractor; wherein, for inserting the medical device, the cap, the insertion component retractor, the locking sleeve and the insertion sleeve are movable relative to the guide sleeve from a distal position to a proximal position, wherein the insertion device is separable from the medical device, wherein the insertion system is separation of the insertion device from the medical device releasing a movement of the locking sleeve from its proximal position to a further proximal position.

Abstract: An insertion device includes an insertion component that inserts a medical device into body tissue of a user. The insertion device also includes an insertion component retractor, a cap, a guide sleeve having a ramp, an insertion sleeve and an elastic member. For inserting the medical device, the cap, the insertion component retractor and the insertion sleeve are movable relative to the guide sleeve from a distal position to a proximal position. The ramp twists the insertion component retractor relative to the guide sleeve and the insertion sleeve when the cap is moved from its distal position to its proximal position. The cap is movable from its proximal position to its distal position and the insertion component retractor is thereby moved from its proximal position to its distal position. An associated method of using the insertion device is also disclosed.

Abstract: A contact assembly for electrically interconnecting at least two modules is disclosed. The contact assembly has a first module having a first contact pad and a second module having a second contact pad. The first and second contact pads are arranged nonparallel to one another. One of the first and second contact pads exerts pressure on an electrically conductive elastomer to thereby deform it, and the deformation results in the other one of the first and second contact pads being contacted by the electrically conductive elastomer. An electrochemical sensor may be part of the first module and an electronics assembly may be part of the second module. An insertion needle may also be provided to insert the sensor transcutaneously. Associated methods are disclosed.

Abstract: An ambulatory infusion device including a pump drive unit, a valve drive unit and a control unit. The pump drive unit includes a pump actuator and a pump driver coupled to a piston of a metering pump unit. The valve drive unit includes a valve actuator and a valve driver coupled to a valve unit for transmitting a valve switching force or torque. The control unit controls a repeated execution of: (a) placing the valve unit in a filling state; (b) displacing the piston in a retraction direction; (c) displacing the piston in an advancing direction by a backlash compensation distance; (d) switching the valve unit from the filling state into a draining state; and (e) further displacing the piston in the advancing direction in a number of incremental steps over an extended time period.

Abstract: A medical system is disclosed. The medical system has a housing and a module received in the housing. The module includes an analyte sensor configured for detecting an analyte in a body fluid of a user, an electronics unit electrically connected to the analyte sensor, an insertion component configured for inserting the analyte sensor into body tissue of the user, and a sterility cap at least partially surrounding the insertion component. A removable protective cap is connected to the housing and covers the module. The protective cap at least partially surrounds the sterility cap. The sterility cap has a sterility testing access that has at least one of a septum and a multiple-step sealing. A method of sterility testing the medical system is also disclosed in which a rinsing liquid is inserted into an interior space of the sterility cap and microbial testing of the rinsing liquid is then completed.

Abstract: A volumetric sampling apparatus for volatile compounds comprises a structure, such as a channel structure that forms a continuous curve between the inlet port and the outlet port. A gas flow induced in the structure urges volatile compounds collected via transdermal diffusion toward the outlet port, where the volatile compounds may be collected and analyzed by a gas composition analyzer coupled to the outlet port.

Abstract: Disclosed is a flow detector (1) for releasable coupling with a flow channel (20) in a channel coupling area and detecting a flow of liquid drug in the flow channel (20), the flow detector including: an upstream thermoelectric element (10a) and a downstream thermoelectric element (10b), wherein the upstream thermoelectric element (10a) and the downstream thermoelectric element (10b) are arranged spaced apart from each other and movable independent from each other; an upstream biasing element (15a) and a downstream biasing element (15b), wherein the upstream biasing element (15a) acts on the upstream thermoelectric element (10a), thereby biasing the upstream thermoelectric element (10a) towards the channel coupling area, and the downstream biasing element (15b) acts on the downstream thermoelectric element (10b), thereby biasing the downstream thermoelectric element (10b) towards the channel coupling area independently from the upstream biasing element (15a).

Abstract: A drug delivery device comprises first and second liquid drug reservoirs and first and second outlet ports. A drive is configured for expelling a first liquid drug from the first reservoir to the first outlet port and for expelling a second liquid drug from the second reservoir to the second outlet port. A memory is provided that contains a drug dosing scheme specifying a desired liquid drug type, and at least one sensor is provided that detects information concerning the type of liquid drug contained in the first and/or second reservoir. A processor receives the information from the at least one sensor and thereby determines the type of liquid drug retained in the first reservoir and/or the second reservoir, and uses the drug dosing scheme and the determined type of liquid drug to operate the drive. Associated devices this disclosure and methods are also disclosed.

Abstract: A method for connecting a force sensor to a circuit board is disclosed. A circuit board having first and second conductive leads located on the same surface of the circuit board is provided. Also provided is a force sensor with a first flexible contact tab having a first contact pad and a second flexible contact tab having a second contact pad. The first contact pad is arranged to face the first conductive lead. A first conductive rubber element establishes an electrical connection between the first contact pad and the first conductive lead, and the second contact pad and the second conductive lead are arranged to face in the same direction. A second conductive rubber element establishes an electrical connection between the second contact pad and the second conductive lead. Also disclosed are an associated device for determining fluid pressure in an insulin pump and an insulin pump.

Abstract: A first connector part (110) for establishing a fluid connection with a second connector part comprises a valve (111) with a valve seat (112), the valve seat comprising a valve chamber (116) and a circular opening with a circumferential sealing lip (114); a valve member (113), the valve member being provided in the valve chamber, and being able to sealingly close the circular opening of the valve seat when being pushed against the circular opening; and a resilient element (115) that subjects the valve member to a bias force pushing the valve member against the circular opening of the valve seat. The valve member further comprises a circumferential wall around the circular opening, located on a side of the circular opening opposite to the valve chamber.

Abstract: Disclosed is a supervision device (9) for supervising liquid drug flow in a flow channel (20). The supervision device (9) includes a flow detector (1), arranged for operatively coupling with the flow channel (20) and generating a flow detector signal in dependence of a flow in the flow channel (20) at a flow detection location. The supervision device (9) further includes a gas detector (8), arranged for operatively coupling with the flow channel (20) and generating a gas detector signal in dependence of whether liquid drug or gas is present in the flow channel (20) at a gas detection location at a distance upstream from the flow detection location.

Abstract: A holder for a medical device has a transcutaneously insertable portion and at least one housing. The holder has at least one mounting device that has a first side and an opposing second side. The mounting device also has a hole reaching from the first side to the second side. The mounting device is configured for being connected to the housing of the medical device. The holder also has two straps that are respectively attached to the mounting device and are fixedly connectable to each other.

Abstract: The invention concerns a reservoir (1) for storing a liquid medicament. The reservoir (1) comprises a flexible container (10) which includes one folding layer (12), wherein the folding layer (12) includes a seam (13) which provides for a sealing of the flexible container (1). The reservoir comprises a rigid part (20) which is connected to the flexible container (10) and which includes a support (25) extending into the flexible container (10) and which includes one or more ports (21, 22) providing fluidic access to the flexible container (10). The reservoir comprises a porous hydrophilic membrane (26) which is connected to the support (25) of the rigid part (20). The invention further concerns a method for producing of a reservoir (1).

Abstract: Disclosed is a method for initializing an ambulatory infusion system. The method includes providing a liquid drug cartridge including a cartridge body, and a cartridge piston. The method further includes providing a dosing unit including a metering pump unit with a dosing cylinder and a dosing piston. The dosing unit further includes a valve unit configured for switching between a filling state and a draining state. The filling port being fluidically coupled with the dosing cylinder in the filling state and the draining port is fluidically coupled with the dosing cylinder in the draining state. The method further includes a) exerting an initialization force displacing the cartridge piston, and b) increasing a fluidic volume of the dosing cylinder by displacing the dosing piston, thereby sucking liquid out of the liquid drug cartridge into the dosing cylinder and further displacing the cartridge piston, without the initialization pushing force being exerted.

Abstract: An analyte measurement kit includes a sensor assembly having a transcutaneous sensor and a controller. The controller includes a battery that powers the sensor assembly and includes a magnetic sensor that generates an electrical activation signal in dependence of a magnetic field. The controller switches from a pre-operative state into an operative state upon generation of the activation signal. The sensor assembly releasably couples to an inserter. The inserter executes an insertion routine that advances the sensor assembly from a retracted position in which the transcutaneous sensor stands back behind a skin contact surface of the inserter into an advanced position in which the transcutaneous sensor projects beyond the skin contact surface, and subsequently decouples the inserter from the sensor assembly. The inserter includes an activation magnet. Executing the insertion routine changes the magnetic coupling between the activation magnet and the sensor assembly and thereby generates the activation signal.

Abstract: The invention concerns a device (1) for measuring a fill level of a flexible medicine reservoir (6). The device (1) comprises a support (2) for supporting the flexible medicine reservoir (6) and a leaf spring member (3). A first section (31) of the leaf spring member (3) is mounted to a fixed bearing. A second section (32) of the leaf spring member (3) is guided by a floating bearing. The leaf spring member (3) is designed for contacting the flexible medicine reservoir (6) and for providing that changes in the fill level of the flexible medicine reservoir (6) effect changes of the form of the leaf spring member (3). A detector (5) is arranged for detecting the effected changes of the form of the leaf spring member (3) and for enabling measuring of the fill level of the flexible medicine reservoir (6).

Abstract: An ambulatory medical device for attachment to a person's body includes a housing having a wall and a vibrator coupler. A convex outer surface of the vibrator coupler projects from the wall towards the outside of the housing. The vibrator coupler is coupled to the wall via a connector arranged along the circumference of the vibrator coupler. A vibrator mechanically vibrates upon activation. The vibrator is arranged at least partially inside a volume defined by the vibrator coupler and is mounted to the vibrator coupler. A skin attachment device is also disclosed. It has a substantially planar body having a skin attachment side and an opposing medical device mounting side. The skin attachment side includes a skin attachment structure for releasably attaching the skin attachment device to a person's skin and the medical device mounting side includes a medical device mount for releasably engaging with the ambulatory medical device.