Drug Delivery Device and Drug Delivery System

Abstract

The present disclosure relates to a drug delivery system and to a drug delivery device, the drug delivery device comprising: a receptacle to accommodate a drug container, wherein the drug container is provided with a container identification, the container identification being at least indicative of a content of the drug container, a container identification arrangement configured to detect and/or to identify the container identification, a delivery device interface configured to transmit uplink data to a communication device, wherein the uplink data contains at least the container identification obtainable from the container identification arrangement and wherein the delivery device interface is configured to receive downlink data from the communication device, and a drive mechanism operably engageable with the drug container and configured to expel a dose of the drug from the drug container on the basis of the downlink data received from the delivery device interface.

Claims

1-15. (canceled)

16. A drug delivery device comprising: a receptacle to accommodate a drug container, wherein the drug container is provided with a container identification, the container identification being at least indicative of contents of the drug container, a container identification arrangement configured to detect and/or to identify the container identification when the drug container is arranged in the receptacle, a delivery device interface configured to transmit uplink data to a communication device, wherein the uplink data contains at least the container identification obtained from the container identification arrangement, and wherein the delivery device interface is configured to receive downlink data from the communication device in response to the transmission of the uplink data, and a drive mechanism operably engageable with the drug container and configured to expel or to dispense at least a dose of a drug from the drug container on the basis of the downlink data received from the delivery device interface.

17. The drug delivery device according to claim 16, further comprising a delivery device processor connected to the delivery device interface and operable to control the drive mechanism on the basis of at least one expelling or dispensing parameter, wherein the delivery device processor is operable: a) to process downlink data obtained from the delivery device interface and to adjust or to modify the at least one expelling or dispensing parameter of the drive mechanism on the basis of the downlink data, or b) to extract the at least one expelling or dispensing parameter of the drive mechanism from the downlink data.

18. The drug delivery device according to claim 17, wherein the delivery device processor is further configured to process at least one physiologic parameter or environmental parameter, and wherein the delivery device processor is configured to adjust or to modify the at least one expelling or dispensing parameter of the drive mechanism on the basis of at least one of the physiologic parameter or environmental parameter.

19. The drug delivery device according to claim 18, further comprising a sensor assembly configured to measure the at least one physiologic parameter or environmental parameter and to transmit the at least one physiologic parameter or environmental parameter to the delivery device processor.

20. The drug delivery device according to claim 17, further comprising a patient identifying arrangement connected to at least one of the delivery device processor or the delivery device interface, the patient identifying arrangement being operable to identify a patient using the drug delivery device, to generate a patient identifier and to incorporate the patient identifier into the uplink data.

21. The drug delivery device according to claim 16, further comprising a delivery device storage configured to store at least one or more of: at least a portion of the container identification, at least a portion of the uplink data, or at least a portion of the downlink data.

22. The drug delivery device according to claim 16, wherein the container identification arrangement comprises at least one of a mechanical sensor, an optical sensor, a capacitive sensor, a magnetic sensor, or an electromagnetic sensor, and wherein the container identification arrangement is operable to generate and to transmit an electronic identification signal indicative of the container identification when the drug container is arranged in the receptacle.

23. The drug delivery device according to claim 16, wherein the drug container arranged in the receptacle is filled with drug or medicament.

24. A drug delivery system comprising: a drug delivery device comprising: a receptacle to accommodate a drug container, wherein the drug container is provided with a container identification, the container identification being at least indicative of contents of the drug container, a container identification arrangement configured to detect and/or to identify the container identification when the drug container is arranged in the receptacle, a delivery device interface configured to transmit uplink data to a communication device, wherein the uplink data contains at least the container identification obtained from the container identification arrangement, and wherein the delivery device interface is configured to receive downlink data from the communication device in response to the transmission of the uplink data, and a drive mechanism operably engageable with the drug container and configured to expel or to dispense at least a dose of a drug from the drug container on the basis of the downlink data received from the delivery device interface; and a communication device comprising: a communication device interface configured to receive uplink data from the delivery device interface and configured to transmit downlink data to the delivery device interface, a communication device processor connected to the communication device interface, the communication device processor being operable: a) to generate at least a portion of the downlink data from the uplink data, and/or b) to transmit at least a portion of the uplink data to an external database via a network and to receive at least a portion of the downlink data from the external database.

25. The drug delivery system according to claim 24, further comprising a delivery device storage configured to store information, the information being at least one or more of: at least a portion of the container identification, at least a portion of the uplink data, or at least a portion of the downlink data.

26. The drug delivery system according to claim 25, wherein the delivery device storage is configured to store information when a communication link to the communication device is interrupted.

27. The drug delivery system according to claim 24, wherein the communication device comprises a patient identifying arrangement connected to at least one of the communication device processor or the communication device interface, the patient identifying arrangement being operable to identify a patient using at least one of the communication device or the drug delivery device, the patient identifying arrangement being operable to generate a patient identifier and to incorporate the patient identifier into the uplink data or to transmit the patient identifier to the communication device processor.

28. The drug delivery system according to claim 24, wherein the communication device processor and the communication device interface are operable to transmit a patient retrieval request to the external database and to receive a patient specific data set from the external database in response to the patient retrieval request, wherein the patient retrieval request includes at least a patient identifier.

29. The drug delivery system according to claim 28, wherein the communication device processor and the communication device interface are operable: a) to incorporate at least a portion of the patient specific data set into the downlink data transmitted to the delivery device interface, or b) to process at least a portion of the patient specific data set and to adjust or to modify at least one of an expelling or dispensing parameter of the drive mechanism of the drug delivery device and to incorporate the at least one expelling or dispensing parameter into the downlink data transmitted to the delivery device interface.

30. The drug delivery system according to claim 24, wherein the drug delivery device comprises a delivery device processor connected to the delivery device interface and operable to control the drive mechanism on the basis of at least one of an expelling or dispensing parameter, wherein the delivery device processor is operable to detect a replacement or an insertion of a drug container in or into the receptacle, and wherein the delivery device processor is further operable to trigger a transmission of a patient retrieval request to the external database via the communication device in response to a detection of the replacement or the insertion of the drug container.

31. A method of adjusting at least one expelling or dispensing parameter of a drug delivery device, the drug delivery device comprising a receptacle to accommodate a drug container, the drug container comprising a container identification being at least indicative of a content of the drug container, the drug delivery device further comprising a drive mechanism operably engageable with the drug container and configured to expel or to dispense at least a dose from the drug container, the method comprises the steps of: determining or detecting the container identification when the drug container is arranged in the receptacle, transmitting uplink data from the drug delivery device to a communication device, wherein the uplink data contains at least the container identification, generating downlink data at least on the basis of the uplink data and transmitting the downlink data to the drug delivery device, and a) processing the downlink data and adjusting or modifying the at least one expelling or dispensing parameter of the drive mechanism on the basis of the downlink data, or b) processing the downlink data and extracting the at least one expelling or dispensing parameter of the drive mechanism from the downlink data.

32. The method of claim 31, further comprising the step of detecting whether the drug container is arranged in the receptacle.

33. The method of claim 31 further comprising the steps of: identifying a patient using the drug delivery device and generating a patient identifier being indicative of the patient, incorporating the patient identifier into the uplink data, retrieving a patient specific data set from an external database on the basis of the patient identifier, and a) incorporating at least a portion of the patient specific data set into the downlink data, or b) adjusting or modifying at least one of an expelling or dispensing parameter of the drive mechanism of the drug delivery device on the basis of the patient specific data set.

34. The method of claim 33, wherein incorporating the patient identifier into the uplink data comprises incorporating only a portion of the patient identifier into the uplink data.

35. The method of claim 33, further comprising the step of storing the at least one of an expelling or dispensing parameter of the drive mechanism of the drug delivery device on the basis of the patient specific data set.

Description

BRIEF DESCRIPTION OF THE FIGURES

[0170] In the following, numerous examples of the drug delivery device, the drug delivery system and of a method of adjusting at least one expelling or dispensing parameter of a drug delivery device are described in detail by making reference to the drawings, in which:

[0171] FIG. 1 shows a block diagram of one example of the drug delivery system,

[0172] FIG. 2 shows a block diagram of another example of the drug delivery system,

[0173] FIG. 3 is indicative of an external database and

[0174] FIG. 4 shows a flowchart of a method of adjusting at least one expelling or dispensing parameter of the drug delivery device.

DETAILED DESCRIPTION

[0175] In FIG. 1, one example of a drug delivery system 100 is schematically illustrated. The drug delivery system 100 comprises a drug delivery device 20. The drug delivery device 20 comprises a housing 21. The drug delivery device 20 further comprises a receptacle 23 configured to receive and/or to accommodate a drug container 10. The drug container 10 is provided with a container identification 52. The drug delivery device 20 further comprises an outlet 44 configured for a fluid transferring engagement with the interior of the drug container. The drug container 10 contains a drug 11 or medicament. The drug 11 may be provided as a liquid drug in the interior of the drug container 10. In the illustration of FIGS. 1 and 2 the drug container 10 is illustrated as a cartridge having a tubular-shaped barrel 12 extending in a longitudinal direction. The barrel 12 and hence the drug container 10 comprises a distal end provided with a seal 13. The drug container 10 comprises an opposite proximal end which is closed by a longitudinally displaceable stopper 14 or bung. The interior volume provided between the seal 13 and the stopper 14 may be entirely filled with the liquid drug. Once there is established a fluid transferring connection between the outlet 44 and the interior volume of the drug container 10 the stopper 14 can be urged in distal direction, hence towards the seal 13 in order to expel an amount, e.g. a dose of the drug 11 from the barrel 12.

[0176] In order to drive or to urge the stopper 14 in distal direction or in a dispensing direction the drug delivery device 20 comprises a drive mechanism 40. The drive mechanism 40 comprises a driver 42, which may be implemented as a plunger or piston rod configured to exert a distally directed pressure onto the stopper 14 in order to drive the same in distal direction during dose expelling or dose dispensing.

[0177] The presently illustrated drive mechanism 40 and the drug container 10 are only exemplary for a large variety of drug containers and dispensing or drive mechanisms by way of which a drug can be expelled or dispensed from a drug delivery device. With other examples the drive mechanism 40 may include a pump, such as a peristaltic pump. Alternatively, the drive 40 mechanism may be implemented as a spray mechanism configured to expel or dispense the drug by way of spraying. The drug container 10 may comprise a flexible bag or a flexible pouch filled with a liquid medicament or filled with a lyophilized drug. A flexible or deformable drug container is particularly configured for coupling with a drive mechanism 40 implemented as a pump. Here, the liquid medicament can be withdrawn from the drug container 10 by a suction force.

[0178] The drug container 10 may also comprise a drug or medicament in powdered form configured for producing an aerosol or configured for spraying.

[0179] Depending on the combination of drug container 10 and a correspondence drive mechanism 40 the drug delivery device 20 may be configured or provided as an injection device, e.g. as a pen-type injector, as an injection pump or infusion pump or as an inhaler.

[0180] The outlet 44 may thus represent an injection needle or a connector for a fluid transferring connection to an injection cannula or an infusion tube. Alternatively, the outlet 44 may represent a mouthpiece, e.g. when the drug delivery device 20 is implemented as an inhaler.

[0181] The drug delivery device 20 comprises a container identification arrangement 50 that is configured to detect and/or to identify the container identification 52 provided on the drug container 10 when the drug container 10 is arranged inside the receptacle 23 of the drug delivery device. The container identification 52 comprises one of a mechanical, optical, capacitive, magnetic and/or electromagnetic encoding that can be detected and read by the container identification arrangement 50. The container identification arrangement 50 is further configured to communicate at least with a delivery device interface 24 of the drug delivery device 20. In this way, a container identification 52 retrieved or detected by the container identification arrangement 50 can be transmitted or transferred to the delivery device interface 24.

[0182] The delivery device interface 24 is configured to transmit uplink data UL to a communication device 60. The uplink data UL contains at least the container identification 52 that has been obtained from the container identification arrangement 50. The delivery device interface 24 is further configured to receive downlink data DL from the communication device 60 in return for the transmission of the uplink data UL to the communication device 60.

[0183] The drive mechanism 40 which is operably engageable with the drug container 10 is e.g. configured to expel or to dispense at least a dose of the drug 11 from the drug container 10 on the basis of the downlink data DL received from the delivery device interface 24. Insofar, the delivery device interface is configured to control, to adjust or to calibrate the drive mechanism 40 upon receipt of downlink data DL.

[0184] Typically, the drug delivery device 20 comprises a delivery device processor 22 that is connected to the delivery device interface 24 and which is further operable to control the drive mechanism 40 on the basis of the downlink data DL received from the communication device 60 and hence from the delivery device interface 24.

[0185] In particular, the delivery device processor 22 is operable to process downlink data DL that has been obtained from the delivery device interface 24 and to adjust or to modify at least one expelling or dispensing parameter of the drive mechanism 40 on the basis of the downlink data DL. Alternatively, the delivery device processor 22 is operable to extract at least one expelling or dispensing parameter of the drive mechanism 40 from the downlink data DL.

[0186] There are several options of the data structure of the downlink data. One option is that the downlink data DL contains drug container specific information that has to be translated into or mapped to an expelling or dispensing parameter that can be processed by the drive mechanism. For this, the delivery device processor 22 is configured to adjust or to modify the at least one expelling or dispensing parameter of the drive mechanism on the basis of the downlink data DL.

[0187] In other examples the expelling or dispensing parameter which may be directly processible by the drive mechanism 40 is already contained in the downlink data DL received from the communication device 60 and/or from the delivery device interface 24. In this case, the delivery device processor 22 only has to extract the at least one expelling or dispensing parameter from the downlink data DL and to forward the expelling or dispensing parameter to the drive mechanism 40 typically during dispensing or expelling of a dose of the drug from the drug container 10.

[0188] The at least one expelling or dispensing parameter provided to the drive mechanism may define a travelling distance or travelling duration of the driver 42 of the drive mechanism 40. The at least one expelling or dispensing parameter may be further indicative of a point of time at which an expelling or dispensing action has to start and/or a point of time at which an expelling or dispensing action should terminate. The expelling or dispensing parameter may be further indicative of at least one of a driving velocity and a driving force of a driver 42 of the drive mechanism 40. Typically, the at least one expelling or dispensing parameter is directly indicative of an operating parameter of the drive mechanism.

[0189] Uplink data UL may be limited to a container identification. Depending on the container identification, e.g. provided to an external database 202 or provided to a communication device 60 the downlink data DL is generated. The downlink data DL may include further information of the identified drug container 10. The downlink data DL may include drug container specific supplemental information, such as information about the drug or medicament, information about the concentration of a pharmaceutically active component in the drug or medicament, information about the durability of the drug, information about the production date. The downlink data DL may further contain information about a treatment schedule according to which the drug or medicament should be administered to a patient. The downlink data DL may be indicative of a treatment schedule and may contain information about a point of time at which a certain amount of the medicament or drug or of the pharmaceutically active component should be dispensed or expelled by the drive mechanism.

[0190] With one example the uplink data UL only contains a container identification. The communication device 60 may be configured to generate respective downlink data DL that is compliant with a prescribed treatment schedule. Here, a treatment schedule may be provided in the communication device 60 or by an external database 202. If for instance a treatment schedule is provided by an external database 202 the communication device 60 is operable to transmit at least a portion of the uplink data UL via a network 200 to the external database 202. In response, the external database 202 is configured to transmit downlink data DL on the basis of received uplink data via the network 200 back to the communication device 60.

[0191] With some examples the entire uplink data UL as provided by the container identification arrangement 50 is unalterably transmitted to the external database 202 or only a portion of the uplink data UL as provided by the delivery device interface 24 is routed or transmitted to the database 202 whereas another portion of the uplink data UL is locally processed by the communication device 60. Accordingly, the entire downlink data or at least a portion thereof may be provided by the database 202 and may be transmitted to the communication device 60. Another portion of the downlink data to be transmitted from the communication device 60 to the drug delivery device 20 may be locally generated or processed by the communication device 60.

[0192] The downlink data received from the database 202 at the communication device 60 may include a delivery schedule, e.g. specifying only the day and time of a drug administration and an amount of the pharmaceutically active substance that should be administered to the patient at the given day and time.

[0193] From this information obtained from the database 202 at the communication device 60 the communication device 60, e.g. the communication device processor 62 may be operable to derive at least one expelling or dispensing parameter specific to the drug delivery device 20. The container identification 52 may be further indicative of a concentration of the pharmaceutically active compound in the drug as provided in the drug container 10. Depending on this concentration information, the communication device 60, e.g. its processor 62 may be operable to modify the at least one expelling or dispensing parameter on the basis of the drug concentration information and on the basis of the total amount of the pharmaceutically active compound that should be administered.

[0194] In one example and when a first drug container 10 is used containing a first drug with a first concentration of a pharmaceutically active compound the at least one expelling or dispensing parameter of the drive mechanism defines, that for a delivery of a prescribed amount of the pharmaceutically active compound the driver 42 of the drive mechanism 40 has to be moved by a first distance.

[0195] Now and on the basis of a second container identification 52 of a second drug container 10 filled with a second medicament having a different, e.g. a lower concentration of the pharmaceutically active compound the at least one expelling or dispensing parameter of the drive mechanism will be adjusted or modified accordingly. In order to administer the required amount of the pharmaceutically active compound, the displacement of the driver 42 has to be modified, e.g. increased. Calculating of such modifications of expelling or dispensing parameters is provided by one of the delivery device processor 22 and the communication device processor 62. There are also examples, wherein the adjusting or modification of such expelling or dispensing parameters is conducted and provided by the external database 202.

[0196] In situations, wherein the expelling or dispensing parameter for the drive mechanism 40 is adjusted or modified on the basis of the uplink data UL by the communication device processor 62 or by the external database 202 the delivery device processor 22 only has to extract the at least one expelling or dispensing parameter from the downlink data DL received from the communication device 60.

[0197] If the adjustment or modification of the at least one expelling or dispensing parameter of the drive mechanism 40 is provided by the external database 202 the functionality of the communication device 60 can be reduced to a mere transmission of uplink data and downlink data between the external database 202 and the drug delivery device 20. With some examples, the communication device 60 is operable to receive uplink data UL from the drug delivery device 20 and to forward the uplink data UL unalterably to the external database 202. With the same or with further examples the communication device 60 may be operable to receive downlink data DL from the external database 202 and to forward the downlink data DL unalterably to the drug delivery device 20.

[0198] With other examples the communication device is operable to derive or to generate at least a portion or the entire downlink data from the uplink data received from the drug delivery device. With other examples, the communication device 60 is operable and configured to process a portion of the uplink data UL received from the drug delivery device 20 and to forward another portion of the uplink data UL to the external database. The communication device 60 is then further operable to receive downlink data DL from the external database 202 and to combine or to incorporate the received downlink data from the external database 202 with downlink data DL generated by the communication device 60.

[0199] The presently proposed architecture of a drug delivery system comprising a drug delivery device capable of identifying a container identification of a drug container and further operable to generate and to transmit uplink data to a communication device provides numerous possibilities of data processing for the purpose of providing a rather automated control, adjustment or calibration of the drive mechanism 40 of the drug delivery device.

[0200] With typical examples the drug delivery device 20 comprises an electronic circuit 46. The electronic circuit 46 may be implemented as an integrated electronic circuit. The electronic circuit 46 may comprise the above described delivery device processor 22 and the delivery device interface 24. The delivery device interface 24 and the delivery device processor 22 may be implemented on one and the same chip or on one and the same integrated circuit.

[0201] Optionally, the electronic circuit 46 and hence the drug delivery device comprises a delivery device storage 26. The delivery device storage 26 may be implemented as a non-volatile memory. The delivery device storage 26 is typically configured or operable to store at least one or more of at least a portion or the entirety of the container identification 52, at least a portion or the entirety of uplink data UL transmitted from the delivery device interface 24 to the communication device 60 and at least a portion or the entirety of downlink data DL received from the communication device 60. In this way, downlink data as well as the at least one expelling or dispensing parameter can be locally stored in the drug delivery device 20. This ensures a reliable and failure safe operation of the drug delivery device 20 even if a communication link with the communication device 60 should not be available.

[0202] The communication device 60 comprises at least a communication device processor 62 and a communication device interface 64. The communication device interface 64 is configured and operable to set up a communication link with the delivery device interface 24. Typically, the communication device interface 64 and the delivery device interface 24 are configured and operable to establish or to set up a wireless communication link operable to transmit uplink data UL and downlink data DL between the drug delivery device 20 and the communication device 60. The wireless communication between the communication device 60 and the drug delivery device may be based on standardized RF communication protocols, such as Bluetooth, NFC or Wi-Fi standards or any other standardized communication protocol enabling a wireless electromagnetic data transmission between the drug delivery device 20 and the communication device 60.

[0203] Alternatively, there may be provided a wired communication link between the communication device 60 and the drug delivery device 20.

[0204] The drug delivery device as illustrated in FIG. 1 comprises numerous optional components indicated with dashed rectangles. As illustrated in FIG. 1, the delivery device storage 26 is provided only optionally. The drug delivery device 20 may further comprise a sensor assembly 80 configured to measure at least one physiologic parameter or environmental parameter and being further configured to transmit the at least one physiologic parameter or environmental parameter to the delivery device processor 22. The sensor assembly 80 comprises at least one sensor 82 and a sensor interface 84. The sensor interface 84 is operable to transmit the at least one physiologic or environmental parameter to the delivery device processor 22 or to the delivery device interface 24.

[0205] The sensor assembly 80 may be integrated into the drug delivery device 20. The drug delivery device 20 and/or its housing 21 may be configured and suitable to be worn on the body or skin of a patient as it is the case for, e.g. an infusion pump. The sensor assembly 80 may also be provided as a separate component of the drug delivery device located outside the housing 21. It may be connected to the drug delivery device 20 either by a wired connection or wirelessly in order to provide the at least one physiologic or environmental parameter to the drug delivery device 20. Here, the at least one physiologic or environmental parameter can be used to further adjust or to modify the at least one expelling or dispensing parameter.

[0206] The sensor assembly 80 can be for instance implemented as a blood glucose measuring sensor providing regular electronic signals being indicative of a blood glucose level of the patient. Depending on the respective physiologic parameter the delivery device processor 22 may be operable to adjust or to modify the amount of medicament or a delivery rate at which the drug or medicament is expelled or dispensed. The delivery device processor 22 and the sensor assembly 80 may be configured in a closed loop configuration. Hence, the processor 22 and hence the drive mechanism 40 controlled by the delivery device processor 22 may be operated or driven at least adjusted or calibrated in response to a regular measurement of the sensor assembly 80.

[0207] Optionally, the drug delivery device 20 further comprises a patient identifying arrangement 34. The patient identifying arrangement 34 is connected to at least one of the delivery device processor 22 and the delivery device interface 24. As described above, the patient identifying arrangement 34 is operable to identify a patient using the drug delivery device 20. The patient identifying arrangement is further operable to generate a patient identifier and to incorporate the patient identifier into the uplink data. The incorporation of the patient identifier into the uplink data UL may be further conducted by one of the delivery device interface 24 and the processor 22 upon receipt of the patient identifier.

[0208] Providing the uplink data UL with a patient identifier enables to receive patient specific downlink data DL from the communication device 60 and/or from the external database 202.

[0209] The downlink data DL may therefore include a patient specific dataset 300 as illustrated in FIG. 3, which patient specific dataset is typically stored in the external database 202 that is provided to the communication device 60 upon a patient retrieval request RR. The patient specific dataset 300 is typically incorporated into the downlink data DL generated and provided by the external database 202.

[0210] Insofar, the patient identifier enables a patient specific control, adjustment and calibration of the drive mechanism as well as a patient specific use of the drug delivery device 20 or of the drug delivery system 100. This principally enables to offer use of one and the same drug delivery device 20 and/or drug delivery system 100 to a group of users. These users may share at least one of a drug delivery device 20, a communication device 60 and a drug delivery system 100. If the patient identifying arrangement 34 recognizes or asserts that a first user is actually using the drug delivery device 20 a respective patient retrieval request is transmitted to the external database 202. Then, the patient specific dataset 300 is incorporated into the downlink data DL and the operation of the drug delivery device 20, e.g. the control, adjustment or calibration of the drive mechanism 40 is adjusted in accordance to the patient specific dataset.

[0211] The delivery device storage 26 of the drug delivery device 20 is of course operable to store the patient specific dataset 300 and/or to store the patient specific expelling or dispensing parameters derived from the downlink data DL that includes the patient specific dataset 300. If the patient identifying arrangement 34 identifies a different person or patient, hence a second patient intending to use the drug delivery device 20 a further patient retrieval request is transmitted to the external database 202. Accordingly, the respective patient specific dataset for the second patient will be transmitted to the drug delivery device 20 and the patient specific settings of the drug delivery device; e.g. a control, adjustment or calibration of the drive mechanism 40 will be adapted accordingly.

[0212] Also here, the patient specific dataset and/or patient specific expelling or dispensing parameters may be locally stored in the delivery device storage 26. If the drug delivery device 20 is then repeatedly used by the first patient, the delivery device processor 22 may be operable to resume the previously stored patient specific data or patient specific expelling or dispensing parameters of the first patient from the delivery device storage 26 without conducting a further patient retrieval request RR.

[0213] The drug delivery device 20 may further comprise an indicator 28 or a display informing the user of drug delivery specific parameters or information. The indicator 28 or display may visually, audibly or haptically indicate to the user or patient that a certain size of a dose is actually set and is due for dispensing or expelling within a certain timeframe. The indicator 28 or display may further inform or alert the user about a malfunction of the drug delivery device 20. The indicator 28 may further remind the user of undertaking some delivery related actions, such as setting of a dose by using an optional dose dial 30 and/or to trigger dispensing or expelling of a dose of the drug by using an optional trigger 32.

[0214] With the example as illustrated in FIG. 1 numerous implementations of the drug delivery systems 100 are conceivable. Here, the functionality of the communication device 60 may be reduced to only provide a communication link between the external database 202 and the drug delivery device 20. The computational logic and computational power for adjusting or modifying the at least one expelling or dispensing parameter may be entirely provided by the drug delivery device 20 itself or by the external database 202.

[0215] With some examples the database 202 is not an external database but belongs to the drug delivery system 100.

[0216] After the drug delivery device has received downlink data DL from the database 202 and after the drive mechanism 40 has been adjusted or calibrated accordingly the drug delivery device 20 may operate in a stand-alone mode without any further interaction with the communication device 60 and/or with the external database 202.

[0217] In FIG. 2 another example of the drug delivery system 100 is illustrated. There, the drug delivery device 20 may be void of all optional components 26, 34, 28, 30, 32 and 80 as described in connection with FIG. 1. Instead, the communication device 60 may be provided with a patient identifying arrangement 74 providing the same or similar functionality as the patient identifying arrangement 34 of the drug delivery device as described above. The communication device 60 may be optionally provided with a communication device storage 66 providing all or similar functionalities compared to the delivery device storage 26 as described before in connection with FIG. 1. The communication device 60 may be further provided with at least one of an indicator 68, a dose dial 70 and a trigger 72 providing the same or similar functionalities as the indicator 28, the dose dial 30 and the triggers 32 as described in connection with FIG. 1. Additionally, the sensor assembly 80 may be provided as a separate component, which is separate from both the drug delivery device 20 and the communication device 60. With other but non-illustrated examples the sensor assembly 80 may be integrated into the communication device 80.

[0218] With the example of FIG. 2, processing of uplink data received by the communication device interface 64 may be entirely or at least partially conducted by the communication device processor 62. Uplink data received from the delivery device interface 24 may be further provided with a patient identifier obtained from the patient identifying arrangement 74 and modified uplink data UL will be transmitted from the communication device 60 via the network 200 to the external database 202.

[0219] With typical examples the communication device 60 is implemented as a smartphone, as a smartwatch or as a tablet computer. The communication device 60 is typically a mobile electronic device. It may be provided with a software application or with a software configured to establish communication with the external database 202 and further configured to establish communication with the drug delivery device 20. With some examples, the drug delivery device 20 may be void of any manually operable actuation members, such as buttons or dials. Instead, the setting of a dose as well as dispensing of a dose may be entirely controlled and triggered via the communication link between the communication device 60 and the drug delivery device 20. For this, the communication device 60 may provide an emulated dose dial 70 and/or an emulated trigger 72.

[0220] It should be noted, that the examples of FIG. 1 and FIG. 2 represent two extreme implementations of the drug delivery system 100. The present disclosure also covers any further implementations of the drug delivery system 100, wherein, when starting from the implementation of FIG. 1 only one of the optional components 26, 28, 30, 32, 34, 80 is provided or implemented externally or in the communication device 60 in form of a corresponding optional component 66, 68, 70, 72, 74.

[0221] In FIG. 3 a patient specific dataset 300 as it is stored in and provided by the external database 202 is schematically illustrated. The patient specific dataset 300 comprises numerous data fields 301, e.g. representing a patient identifier or a data field 302, e.g. representing a container identification. The container identification 302 may be indicative of a drug name, a drug concentration as well as of a unique LOT or batch number. The patient specific dataset 300 may further comprise a data field 303 defining a particular date representing a best before date or a durability date until which the drug or medicament can be used. There may be further provided a data field 304 indicating the production date of the drug or medicament.

[0222] The patient specific dataset 300 may further comprise a data field 305 representing and/or providing a delivery schedule. The delivery schedule 305 may represent numerous dates and/or times at which a certain amount of the medicament should be administered at a given or prescribed delivery rate.

[0223] Medical staff or caregivers typically have access to the external database 202. In this way, a medicament prescription schedule and hence a delivery schedule can be stored in the external database 202. The external database 202 is typically accessible via a network 200. Insofar the database 202 may be physically located in or represented by a data cloud.

[0224] Moreover, the patient specific dataset 300 may comprise another data field 306 for storing feedback data obtained from the drug delivery device, e.g. about a successful completion of a drug administering procedure, a confirmation message may be automatically generated and transmitted from one of the drug delivery device 20 and the communication device 60 to the external database 202. Insofar, treatment data can be automatically uploaded to the external database and to a data cloud.

[0225] With the presently proposed drug delivery system and the associated infrastructure it is generally conceivable to implement a large variety of different scenarios of use.

[0226] For instance, one of the drug delivery device 20 and the communication device 60 may be pre-programmed to trigger transmission of a patient retrieval request RR at regular time intervals, e.g. once a week. This offers the possibility for a healthcare provider to modify the patient specific dataset if required. In response to the patient retrieval request or when a drug container is replaced in the drug delivery device 20 a new calibration and adjustment of the drive mechanism 40 is automatically conducted on the basis of the downlink data DL received in response to the patient retrieval request RR or in response to the transmission of uplink data UL that is automatically triggered in response to the replacement of a drug container. In this way, the delivery schedule can be dynamically changed, e.g. via a modification of patient specific data in the database 202. In order to change a treatment schedule no hardware or software modifications have to be made with the drug delivery device or with the communication device 60.

[0227] In FIG. 4, only one of a plurality of examples of a flowchart according to the presently described method of adjusting at least one expelling or dispensing parameter of a drug delivery device is illustrated. In a first step 400 a patient ID is gathered, e.g. by the patient identifying arrangement 34, 74 as provided by the drug delivery device 20 according to FIG. 1 or as provided by the communication device 60 as illustrated in FIG. 2. Thereafter, and based on the patient identifier in step 402 a patient specific dataset is requested from the external database 202. Hence, a delivery schedule for a patient with the respective patient ID is requested. In a subsequent step 404 the delivery schedule is derived from the patient specific dataset as provided to the communication device 60 and/or to the drug delivery device 20. Concurrently with steps 400, 402 and 404 the drug container 10 as located inside the receptacle 23 is identified in step 408. The identification is conducted by the container identification arrangement 50. In step 410, the identified or derived container identification is provided to at least one of the delivery device processor 22 and the communication device processor 62.

[0228] In a subsequent step 412 the delivery schedule as provided in step 404 and the container identification as provided in step 410 are mutually compared. In step 412 it is checked whether the container ID and the respective drug provided by the container matches with or is suitable for the delivery schedule as provided in step 404. If it is determined in step 412, that the drug 11 as identified in step 410 does not match with the prescribed delivery schedule as provided in step 404, the method continues with step 414. There, an alert, e.g. a visual alert, an audible alert and/or a haptic alert is generated and/or delivery of the drug by the drive mechanism 40 is blocked. For instance, the drive mechanism 40 may be locked in step 414. The alert is an indication to the user to change the drug container.

[0229] Thereafter, at least steps 408 and 410 have to be processed again. If in step 412 it then turns out, that the identified drug container and the respective drug matches with the delivery schedule as provided in step 404 then the method continues with step 416. Here, at least one expelling or dispensing parameter of the drive mechanism 40 is adjusted or modified on the basis of the data obtained in at least one of the steps 404, 410. In step 416 the drive mechanism may be adjusted or calibrated in view of, e.g. the drug concentration provided in the drug container. Thereafter and in an optional step the prescribed drug or medicament is expelled or dispensed actively or drug expelling or drug dispensing is no longer blocked.

REFERENCE NUMBERS

[0230] 10 drug container [0231] 11 drug [0232] 12 barrel [0233] 13 seal [0234] 14 stopper [0235] 20 drug delivery device [0236] 21 housing [0237] 22 delivery device processor [0238] 23 receptacle [0239] 24 delivery device interface [0240] 26 delivery device storage [0241] 28 indicator [0242] 30 dose dial [0243] 32 trigger [0244] 34 patient identifying arrangement [0245] 40 drive mechanism [0246] 42 driver [0247] 44 outlet [0248] 46 electronic unit [0249] 50 container identification device [0250] 52 container identification [0251] 60 communication device [0252] 61 housing [0253] 62 communication device processor [0254] 64 communication device interface [0255] 66 communication device storage [0256] 68 indicator [0257] 70 dose dial [0258] 72 trigger [0259] 74 patient identifying arrangement [0260] 80 sensor assembly [0261] 82 sensor [0262] 84 interface [0263] 100 drug delivery system [0264] 200 network [0265] 202 database [0266] 300 data set