Medicament delivery device

Abstract

The present disclosure relates to a medicament delivery device (1) comprising a medicament container (2), the medicament container having a proximal end (2a) and a distal end (2b) and the medicament container comprising a medicament delivery member (3) having a proximal end (3a), the medicament delivery device comprising: - a power module (4) having a plunger rod (5) configured to act on the medicament container to expel medicament via the proximal end of the medicament delivery member, - a drive unit (41) configured to move the plunger rod in the proximal direction, - a user interface (13) including a pause control element (14) arranged to manually control a pause state for the movement of the plunger rod in the proximal direction, - a control unit (42) configured to: - initiate a pre-injection state, and - initiating an injection state and thereby moving the plunger rod in the proximal direction, wherein the pause state of the plunger rod is enabled during the pre-injection state and disabled at the initiation of the injection state. The present disclosure furthermore relates to a method for delivering a medicament with a medicament delivery device and a computer program comprising program code for performing the method.

Description

[0001] MEDICAMENT DELIVERY DEVICE

[0002] TECHNICAL FIELD

[0003] The present disclosure generally relates to medical devices for medicament administration.

[0004] BACKGROUND

[0005] A number of medical conditions require injections. These days, a number of different injection devices exist, including various types of pen injectors, autoinjectors and on-body devices. Although many of these devices have enabled major improvements in the management of a number of medical conditions, various limitations do still exist in the current technology.

[0006] For example, the medicament container holding the medicament may comprise air or gas trapped inside the medicament container which may disturb, or complicate, the medicament administration. For example, for certain medicament delivery devices, a medicament container comprises several doses of medicament, and it is important to administer the correct amount of medicament in every dose during injection actions of the medicament delivery device. Air or gas trapped inside the medicament container may result in an inadequate amount of medicament in at least one dose. There are also other reasons why it is desirable to remove air or gas prior to a medicament delivery event. The medicament container may be subject to pre-injection actions, such as priming in which air or gas is removed prior to a medicament delivery event.

[0007] Pre-injection actions and injection actions serve different purposes but typically uses the same expel function of the medical device. However, due to the different nature of injection and pre-injection actions, it is sometimes desirable to adapt the expel function depending on the action.

[0008] In considering these problems, the applicant has appreciated that various developments could be made to help improve the medicament delivery devices on the market today, which are set out in more detail below. SUMMARY

[0009] An object of the present disclosure is to provide a versatile medicament delivery device configured for delivering a medicament which is suitable for use for wide variety of medicaments, and which solves, or at least mitigates problems of the prior art.

[0010] There is hence provided a medicament delivery device comprising a medicament container, the medicament container having a proximal end and a distal end and the medicament container comprising a medicament delivery member having a proximal end, the medicament delivery device comprising:

[0011] - a power module having a plunger rod configured to act on the medicament container to expel medicament via the proximal end of the medicament delivery member,

[0012] - a drive unit configured to move the plunger rod in the proximal direction,

[0013] - a user interface including a pause control element arranged to manually control a pause state for the movement of the plunger rod in the proximal direction,

[0014] - a control unit configured to:

[0015] - initiate a pre-inj ection state, and

[0016] - initiate an injection state and thereby moving the plunger rod in the proximal direction, wherein the pause state of the plunger rod is enabled during the pre-inj ection state and disabled at the initiation of the injection state.

[0017] Since the pause state is disabled at the initiation of the injection state and remains disabled during the complete injection state, the injection state may be performed continuously without the possibility for a caregiver or a patient to pause the injection. This enables the medicament delivery device to be used for medicaments with a predefined injection profile, since pausing during the injection state would lead to a deviation from the predefined injection profile. Thus, the medicament delivery device is improved with regards to fidelity of medicament administration, e.g. with regards to improved reliability of medicament administrations following a predefined injection profile. The fact that the medicament is provided with a user interface including a pause control element enables manually pausing the movement of the plunger rod during the pre-inj ection state, which may enable enhanced control of the device, such as for inspecting the system for leaks, inspecting settings or connections or the like prior to the injection state.

[0018] In the present disclosure, when the term “distal direction” is used, this refers to the direction pointing away from the dose delivery site during use of the medicament delivery device. When the term “distal part / end” is used, this refers to the part / end of the delivery device, or the parts / ends of the members thereof, which under use of the medicament delivery device is / are located furthest away from the dose delivery site.

[0019] Correspondingly, when the term “proximal direction” is used, this refers to the direction pointing towards the dose delivery site during use of the medicament delivery device.

[0020] When the term “proximal part / end” is used, this refers to the part / end of the delivery device, or the parts / ends of the members thereof, which under use of the medicament delivery device is / are located closest to the dose delivery site.

[0021] Further, the term “longitudinal”, “longitudinally”, “axially” or “axial” refer to a direction extending from the proximal end to the distal end, typically along the device or components thereof in the direction of the longest extension of the device and / or component. Similarly, the terms “transverse”, “transversal” and “transversally” refer to a direction generally perpendicular to the longitudinal direction.

[0022] Further, the terms “circumference”, “circumferential”, or “circumferentially” refer to a circumference or a circumferential direction relative to an axis, typically a central axis extending in the direction of the longest extension of the device and / or component.

[0023] Similarly, “radial” or “radially” refer to a direction extending radially relative to the axis, and “rotation”, “rotational” and “rotationally” refer to rotation relative to the axis.

[0024] In the present disclosure, when the term “pause control element” is used, this refers to a physical control element, such as a pause button, or to a pause icon on a touchscreen.

[0025] According to one embodiment, the user interface comprises a start control element, i.e. a physical control element, such as a start button, or to a start icon on a touchscreen. The start control element may be arranged to manually control a start state for the movement of the plunger rod in the proximal direction.

[0026] In the present disclosure, the pre-inj ection state may include assembly, activation, needle preparation or sterilization, medicament mixing, dose confirmation, medicine inspection (visual inspection of the medicine in the cartridge), or priming.

[0027] According to one embodiment, the pre-inj ection state is a priming state, and the control unit is configured to initiate a priming state by moving the plunger rod in the proximal direction, such as to remove air or gas from the medicament container or for closing mechanical gaps between plunger and plunger rod and / or inside the power unit. Optionally, a hose and a needle are connected at a proximal end of the medicament container, in such case, the priming state may include moving the plunger rod in the proximal direction to remove air or gas from the medicament container, the hose and the needle. The control unit may typically be configured to initiate a priming state when the medicament delivery device has been mounted. The plunger rod is moved in the proximal direction by the drive unit. The fact that the medicament delivery device is provided with a user interface including a pause control element arranged to manually control a pause state for the movement of the plunger rod in the proximal direction may for example enable starting and pausing of the movement of the plunger rod to prime air or gas out prior to initiation of the injection state, it may furthermore enable healthcare professionals to pause the priming to check that air or gas bubbles effectively have been removed.

[0028] It should be noted that air is to be interpreted broadly and may be referring to any type of gas, e.g. containing oxygen and / or nitrogen, typically as air bubbles or gas bubbles. Priming may thus be referred to as the action of expelling air bubbles or gas bubbles from the medicament container.

[0029] According to one embodiment, the control unit is configured to determine an end-of-priming state when the plunger rod has reached a predetermined position, in which end-of priming state the plunger rod is held in a fixed position. By determining an end-of-priming state, the control unit maybe configured to instruct the drive unit to stop the movement of the plunger rod in the proximal direction when the predetermined position has been reached. The control unit may be configured to continuously monitor the position of the plunger rod, such as via sensors and when the plunger rod reaches the predetermined position (within the medicament delivery device), the control unit may be configured to processes this information and generate a stop / paus command, i.e. an electronic signal instructing the drive unit to cease its operation.

[0030] According to one embodiment, the control unit is configured to disable pause state upon determination of the end-of-priming state or wherein the control unit is configured to disable the pause state when the end-of-priming state and one or more additional predetermined conditions are met. Hence, the control unit is configured to evaluate whether the condition that the plunger rod has reached the predetermined position is met and subsequently disable the pause state, i.e. removing the option for manual control of the pause state via the pause control element, or alternatively the control unit is configured to first evaluate whether the condition that the plunger rod has reached the predetermined position is met and then subsequently evaluate whether one or more additional conditions is / are met and when these predefined two or more conditions are met disable the pause state. For example, the control unit maybe configured to disable the pause state when a dual condition is fulfilled, e.g. where end-of-priming state is one condition and initiation of the injection state is the other condition to be met.

[0031] According to one embodiment, the control unit is configured to define an end-of-priming state based on that the plunger rod has moved a predetermined distance in the proximal direction. In the period prior to that the plunger rod has moved the predetermined distance in the proximal direction, the pause control element, and an optional start control element, may be used to prime the medicament container from air.

[0032] According to one embodiment, the medicament delivery member comprises a flexible tube fluidly connected to the medicament container and a needle attached to the flexible tube, wherein the predetermined distance is determined based on the maximum foreseeable air volume in the medicament container, the flexible tube and the needle, all combined.

[0033] According to one embodiment, the medicament delivery device comprises an electronic tag provided with information of the predetermined distance or alternatively with the predetermined position. The inclusion of an electronic tag, such as an RFID, containing information of the predetermined distance or the predetermined position, allows the power unit to read this data after being assembled with a medical container or a member comprising the medical container. This enables the power unit to be used with medical containers and medicament delivery members of varying sizes while ensuring that the plunger rod moves the correct distance to complete the priming process, hence enhancing versatility and cost-efficiency. Furthermore, the control unit maybe configured to initiate a priming state after assembly of the medicament delivery device and reading of the electronic tag.

[0034] According to one embodiment, the control unit is configured to define the end-of-priming state in response to that the plunger rod has moved in the proximal direction and exceeded a predetermined force level required to move the plunger rod in the proximal direction. Pushing air out from the medicament container gives a lower force requirement, however once the liquid medicament reaches the needle, the force level is increased. Once, the force level increases and the control unit detects that the predetermined force level is exceeded, such as via a sensor, the control unit may initiate disablement of the pause state. The predetermined force level may be associated with a movement of the plunger rod a predefined distance in the proximal direction.

[0035] According to one embodiment, the control unit is configured to either determine the force level required to move the plunger rod in the proximal direction or to determining an electrical measured quantity required by the drive unit to move the plunger rod in the proximal direction. The electrical measured quantity here may e.g. be the current or the power required by the drive unit to move the plunger rod in the proximal direction. The movement of the plunger rod in the proximal direction may be referring to movement of the plunger rod a predefined distance in the proximal direction.

[0036] According to one embodiment, the predefined priming position is corresponding to the maximum foreseeable air volume of the medicament container. That is, a certain volume of the medicament container may correspond to an associated predefined priming position of the plunger rod. Hereby, the predefined priming position of the plunger rod can be adapted to the volume of the medicament container.

[0037] According to one embodiment, the user interface comprises a start control element, i.e. a physical control element, such as a start button, or to a start icon on a touchscreen. The start control element may be arranged to manually control a start state for the movement of the plunger rod in the proximal direction.

[0038] According to one embodiment, the medicament delivery device may comprise a disposable cassette accommodating the medical container.

[0039] By means of the disposable cassette, variable medicament containers having different volumes are possible to use by the same power module. Thus, the volume of the medicament container can range from smaller volumes of about 2 ml to larger volumes of about io ml or more depending on the size of the disposable cassette. Regardless of medicament volume, the engagement of the disposable cassette with the power module forming the medicament delivery device is the same. The disposable cassette is sometimes simply referred to as “the cassette” throughout this application.

[0040] According to one embodiment, the power module comprises a proximal receiving interface adapted to receive and connect to the disposable cassette.

[0041] According to a second aspect of the present disclosure, there is provided method for delivering a medicament with a medicament delivery device, the medicament delivery device comprising a medicament container, the medicament container having a proximal end and a distal end, the medicament container comprising a medicament delivery member having a proximal end, the medicament delivery device comprising a power module comprising a plunger rod configured to act on the medicament container to expel medicament via the proximal end of the medicament delivery member and a drive unit configured to move the plunger rod in a proximal direction and a control unit configured to instruct the drive unit to move the plunger rod in the proximal direction, the medicament delivery device further comprising a user interface including a pause control element arranged to manually control a pause state for the movement of the plunger rod in the proximal direction, the method comprising; initiating, by the control unit, a pre-inj ection state, and initiating, by the control unit, an injection state thereby moving the plunger rod further in the proximal direction, wherein the pause state of the plunger rod is enabled during the pre-inj ection state and disabled at the initiation of the injection state.

[0042] Effects and features of the second aspect are largely analogous to those described above in connection with the first aspect. Embodiments mentioned in relation to the first aspect are largely compatible with the second aspect, and vice versa, of which some are exemplified below.

[0043] According to one embodiment, the pre-inj ection state is a priming state and wherein the method includes initiating a priming state by moving the plunger rod in the proximal direction, such as to remove air or gas from the medicament container or for closing mechanical gaps between plunger and plunger rod and / or inside the power unit. The plunger rod is moved in the proximal direction by the drive unit. The fact that the medicament delivery device is provided with a user interface including a pause control element arranged to manually control a pause state for the movement of the plunger rod in the proximal direction may for example enable healthcare professionals to pause the priming to check that air or gas bubbles effectively have been removed.

[0044] According to one embodiment, the method includes determining by the control unit an end-of-priming state when the plunger rod has reached a predetermined position in which end-of priming state the plunger rod is held in a fixed position. Upon determination of an end-of-priming state by the control unit, the control unit may instruct the drive unit to stop the movement of the plunger rod in the proximal direction when the predetermined position has been reached. The method may include a continuous monitor of the position of the plunger rod by the control unit, such as via sensors and when the plunger rod reaches the predetermined position (within the medicament delivery device), the control unit maybe configured to processes this information and generate a stop / paus command, i.e. an electronic signal instructing the drive unit to cease its operation.

[0045] According to one embodiment, the pause state is disabled by the control unit when the end-of-priming state has been determined or when the end-of- priming state and one or more additional predetermined condition(s) are met. In other words, the ability to manually initiate a pause state by the pause control element is prevented. Hence, the method may include evaluating, by the control unit, whether the condition that the plunger rod has reached the predetermined position is met and subsequently disable the pause state, i.e. removing the option for manual control of the pause state via the pause control element, or alternatively to first evaluate, by the control unit, whether the condition that the plunger rod has reached the predetermined position is met and then subsequently evaluate whether one or more additional conditions is / are met and when these predefined two or more conditions are met disable the pause state. For example, the method may include to disable the pause state, by the control unit, when a dual condition is fulfilled, e.g. where end-of-priming state is one condition and initiation of the injection state is the other condition to be met.

[0046] According to one embodiment, the end-of-priming state is defined in response to that the plunger rod has moved a predetermined distance in the proximal direction. In the period prior to that the plunger rod has moved the predetermined distance in the proximal direction, the pause control element, and an optional start control element, may be used to prime the medicament container from air.

[0047] According to one embodiment, the medicament delivery member comprises a flexible tube fluidly connected to the medicament container and a needle attached to the flexible tube, and wherein the predetermined distance is determined based on the maximum foreseeable air volume in the medicament container, the flexible tube and the needle, all combined. According to one embodiment, the medicament delivery device comprises an electronic tag provided with information of the predetermined distance, or alternatively with the predetermined position, and the method includes electronically reading the electronic tag to set the predetermined distance or the predetermined position. The electronic tag, such as an RFID, may be read by the power unit at assembly of the medicament delivery device since the same power unit may be unit in combination with medicament containers of varying volume. This enables the power unit to be used with medical containers and medicament delivery members of varying sizes while ensuring that the plunger rod moves the correct distance to complete the priming process, hence enhancing versatility and cost-efficiency.

[0048] According to one embodiment, the end-of-priming state is defined in response to that the plunger rod has moved in the proximal direction and exceeded a predetermined force level required to move the plunger rod in the proximal direction. Pushing air out from the medicament container gives a lower force requirement, however once the liquid medicament reaches the needle, the force level is increased. Once, the force level increases and the control unit detects that the predetermined force level is exceeded, such as via a sensor, the control unit may initiate disablement of the pause state. The predetermined force level maybe associated with a movement of the plunger rod a predefined distance in the proximal direction.

[0049] According to one embodiment, the force level is either determined by the control unit by input from a sensor determining the mechanical force required to move the plunger rod in the proximal direction or by input from a sensor determining the electrical force required by the drive unit to move the plunger rod in the proximal direction. The movement of the plunger rod in the proximal direction may be referring to movement of the plunger rod a predefined distance in the proximal direction.

[0050] According to one embodiment, the predefined priming position is corresponding to the maximum foreseeable air volume of the medicament container. That is, a certain volume of the medicament container may correspond to an associated predefined priming position of the plunger rod. Hereby, the predefined priming position of the plunger rod can be adapted to the volume of the medicament container.

[0051] According to one embodiment, the medicament delivery device may comprise a disposable cassette accommodating the medical container.

[0052] By means of the disposable cassette, variable medicament containers having different volumes are possible to use by the same power module. Thus, the volume of the medicament container can range from smaller volumes of about 2 ml to larger volumes of about io ml or more depending on the size of the disposable cassette. Regardless of medicament volume, the engagement of the disposable cassette with the power module forming the medicament delivery device is the same. The disposable cassette is sometimes simply referred to as “the cassette” throughout this application.

[0053] According to one embodiment, the power module comprises a proximal receiving interface adapted to receive and connect to the disposable cassette.

[0054] According to a third aspect of the present disclosure, there is provided a computer program product comprising program code for performing, when executed by the processing circuitry, the method according to the second aspect.

[0055] Generally, all terms used in the claims are to be interpreted according to their ordinary meaning in the technical field, unless explicitly defined otherwise herein. All references to "a / an / the element, apparatus, component, means, etc.” are to be interpreted openly as referring to at least one instance of the element, apparatus, component, means, etc., unless explicitly stated otherwise.

[0056] BRIEF DESCRIPTION OF THE DRAWINGS

[0057] The specific embodiments of the inventive concept will now be described, by way of example, with reference to the accompanying drawings, in which: Fig. 1 is a perspective view of a medicament delivery device according to embodiments of the present disclosure;

[0058] Fig. 2 is a perspective view of the medicament delivery device with housing removed according to embodiments of the present disclosure; and

[0059] Fig. 3 is a flowchart illustrating the steps of a method in according to embodiments of the present disclosure.

[0060] DETAILED DESCRIPTION

[0061] The inventive concept will now be described more fully hereinafter with reference to the accompanying drawings, in which exemplifying embodiments are shown. The inventive concept may, however, be embodied in many different forms and should not be construed as limited to the embodiments set forth herein; rather, these embodiments are provided by way of example so that this disclosure will be thorough and complete, and will fully convey the scope of the inventive concept to those skilled in the art. Like numbers refer to like members throughout the description.

[0062] Fig i shows an example of a medicament delivery device i such as an autoinjector of an injection device according to embodiments of the present disclosure. The medicament delivery device i is configured to expel medicament from a medicament container 2 via a medicament delivery member 3, here embodied as a flexible tube 8 and a needle 9 attached to the flexible tube 8, to a user at a dose delivery site. The medicament delivery device 1 extends from a proximal end la to a distal end ib relative to an axis 101 and the medicament container 2 similarly has a proximal end 2a and a distal end 2b in relation to the axis 101.

[0063] The medicament delivery device 1 comprises a power module 4 which is connectable to a disposable cassette 6 having a proximal end 6a and a distal end 6b. The power module 4 has a corresponding proximal end 4a and distal end 4b, and comprises a housing 7. It should however be noted that the disposable cassette 6 is an optional feature and the power module 4 may alternatively be directly connected to the medicament container 2, which is here illustrated as being accommodated in the disposable cassette 6.

[0064] The disposable cassette 6, as illustrated in this Figure, comprises a tubular main body n accommodating the medicament container 2 and the thereto arranged medicament delivery member 3 having a proximal end 3a. In the embodiment of Fig. 1, in which the medicament delivery member 3 comprises a flexible tube 8 fluidly connected to the medicament container 2 and a needle 9 attached to the flexible tube 8, the proximal end 3a of the medicament delivery member 3 is the tip of the needle 9. The disposable cassette 6 is typically adapted to accommodate medicament containers of different volumes, for example ranging from about 1 ml to about 10 ml.

[0065] The power module 4 comprises a receiving interface 12 configured to receive and lock the disposable cassette 6 to the proximal end 4a of the power module 4.

[0066] The medicament delivery device 1 furthermore comprises a user interface 13, such as button(s) and / or a touchscreen. The user interface 13 includes a pause control element 14 arranged to manually control a pause state for the movement of a plunger rod 5 in the proximal direction. The pause control element 14 may be a physical pause button or a pause button icon on a touchscreen. The user interface 13 may optionally include a start control element, such as a physical start button or a start button icon on a touchscreen. In Fig. 1 the user interface 13 and the pause control element 14 is depicted as a physical start / pause button.

[0067] Fig. 2 is a partly exploded view of a medicament delivery device 1 with the housing 7 removed from the power module 4. The power module 4 is a power module according to Fig. 1 but the disposable cassette 6’ and the medicament delivery member 3’ is exchanged. As shown in Fig. 2, the housing 7 may be divided in two parts, a first housing part 7a and a second housing part 7b, wherein the second housing part 7b is arranged distally of the first housing part 7a. The power module 4 comprises a plunger rod 5 configured to move proximally to act on the medicament container 2’ to expel air or gas, and medicament, via the proximal end 3a’ of the medicament delivery member 3’, in this picture depicted as a needle and the tip of the needle. The medicament delivery device 1 further comprises a drive unit 41 configured to move the plunger rod 5 in the proximal direction. In the embodiment of Fig. 2, the drive unit 41 is comprised in the power module 4, and housed withing the housing 7. The drive unit 41 may be exemplified by an electrical motor.

[0068] The medicament delivery device 1 comprises a control unit 42 being configured to initiate a pre-inj ection state, and to initiate an injection state, thereby moving the plunger rod 5 in the proximal direction. During the preinjection state the pause state of the plunger rod 5 is enabled, however during, including prior to, the initiation of the injection state, the control unit 42 is configured to disable the pause state of the plunger rod 5. Disabling manual control of the pause state of the plunger rod 5 permits the medicament delivery device to be used for medicaments with a predetermined injection profile, as pausing of the injection would result in a deviation from the predetermined injection profile.

[0069] The control unit 42 may continuously monitor the position of the plunger rod 5, such as via sensors and when the plunger rod 5 reaches the predetermined position, the control unit 42 processes this information and generates a stop / paus command, i.e. an electronic signal instructing the drive unit 41 to cease its operation.

[0070] The medicament delivery device 1 comprises a user interface 13, i.e. such as a display screen, buttons and / or a touchscreen. The user interface 13 includes a pause control element 14 arranged to manually control a pause state for the movement of the plunger rod 5 in the proximal direction. The pause control element 14 may be a physical pause button or a pause button icon on a touchscreen. In this Fig. 2, the user interface 13 is illustrated as a physical start / paus button. The user interface may thus optionally include a start control element, such as a physical start button or a start button icon on a touchscreen.

[0071] The power module 4 may optionally comprise an antenna 43 (or a set of antennas) and a power pack 44 with electronic circuitry and batteries.

[0072] The medicament delivery device 1 may optionally comprise an electronic tag 10, here attached at a distal end portion of the cassette 6’. If the medicament deliver device 1’ includes a disposable cassette 6’, the electronic tag is preferably attached to the cassette 6’. The electronic tag 10 is typically configured to store data that is related to the medicament contained within the medicament container 2’, e.g. the medicament volume. The electronic tag 10 and the data therein may be readable by an electronic reader of the medicament delivery device 1 when the disposable cassette 6’ is in an attached position in the power module 4. The electronic reader may e.g. comprise the previously mentioned antenna 43. The control unit 42 maybe configured to initiate the priming state after assembly of the medicament delivery device 1 and reading of the electronic tag 10.

[0073] Fig. 3 is a flow-chart describing steps of a method for delivering a medicament with medicament delivery device 1, according to embodiments of the present disclosure.

[0074] In a first step S10 of the method, a pre-injection state is initiated by the control unit 42. The pre-injection state as disclosed herein may for example include assembly, activation, needle preparation or sterilization, medicament mixing, dose confirmation, medicine inspection (visual inspection of the medicine in the cartridge), or priming. During the pre-injection state, the pause state of the plunger rod 5 is enabled, allowing the manual control of the paus control element 14 to pause the plunger rod’s 5 movement in the proximal direction if needed. Thus, the control unit 42 is configured to instruct the drive unit to stop the movement of the plunger rod 5 when the pause control element 14 is manually activated, such as pressed. In a step S20, the pause state is disabled, for example such as the control unit 42 is programmed to ignore input from the pause control element 14, or alternatively, the control unit 42 may physically disconnect a circuit of the pause control element 14 using electronic switches controlled by the control unit 42 making the pause control element 14 non-functional.

[0075] In step S30, an injection state is initiated by the control unit 42, and thereby moving the plunger rod 5 in the proximal direction. In this step, the control unit 42 instructs the drive unit 41 to automatically move the plunger rod 5 in the proximal direction to act on the medicament container 2 and expel medicament through the proximal end of the medicament delivery device 3. The control unit 42 may optionally initiate the injection state as a response to input from a start control element, such as a physical start button or start icon on a touch screen.

[0076] Step S20 of disabling the pause state maybe carried out at the end of preinjection state, i.e. at the endpoint of step S10, or between step S10 and step S30 or upon initiation of step S30.

[0077] When the pre-injection state is a priming state, step S10 includes initiating a priming state by moving the plunger rod 5 in the proximal direction, such as to remove air or gas from the medicament container 2 or for closing mechanical gaps between plunger and plunger rod and / or inside the power unit. For such method, an optional sub step Sioa maybe included, where the control unit 42 determines an end-of-priming state when the plunger rod 5 has reached a predetermined position in which end-of priming state the plunger rod 5 is held in a fixed position.

[0078] Optionally, step S10 of disabling the pause state by the control unit 42 is a consequence of sub step 10a of determining the end-of-priming state, such embodiment may further include that the end-of-priming state is one of two or more conditions to be met before setting the command of disabling the pause state. For example, a dual condition maybe that the control unit 42 has determined an end-of-priming state and at a command of initiating of injection state, the pause state maybe disabled.

[0079] Step 10a of defining an end-of-priming state may be based on that the plunger rod 5 has moved a predetermined distance in the proximal direction. Alternatively, the end-of-priming state may be determined based on that the plunger rod has moved in the proximal direction and exceeded a predetermined force level required to move the plunger rod in the proximal direction.

[0080] The force level may for example be determined by a sensor determining the mechanical forced required to move the plunger rod in the proximal direction or a sensor determining the electrical force required by the drive unit to move the plunger rod in the proximal direction.

[0081] As illustrated in Fig. 1, the medicament delivery member 3 may comprise a flexible tube 8 fluidly connected to the medicament container 2 and a needle 9 attached to the flexible tube 8 and the predetermined distance may be determined based on the maximum foreseeable air volume in the medicament container 2, the flexible tube 8 and the needle 9, all combined.

[0082] The medicament delivery device 1 may furthermore comprises an electronic tag 10 provided with information of the predetermined distance and the method optionally includes a pre-step S5, prior to step S10, of electronically reading the electronic tag 10 to set the predetermined distance.

[0083] A medicament delivery device (such as an autoinjector) may generally include various other components. For example, a sensor unit which may recognize medicament delivery events, such as the medicament delivery member inserted into an attachment portion of e.g., a pad, injection started, and medicament delivery event ends, a memory unit which is configured to store the recorded data during the medicament delivery event, a connectivity unit configured to transmit the stored data to a smart device or the network directly, a processing unit (e.g. the previously described control unit 42) configured to control the entire system and processes the data before transmitting it, and / or user interface units that are configured to provide feedback to the patient, such as status LEDs, haptic, and / or audio feedback.

[0084] When the medicament delivery device is placed into the attachment portion, the sensors inside of the pad are configured to recognize the event and give feedback to the patient via haptic / visual or audio elements.

[0085] When the medicament delivery event finishes, the sensors are configured to recognize the event and give feedback to the patient again. Further, the collected data is stored in the memory unit and may be transmitted to the smart device / network via the connectivity unit after the medicament delivery event finishes.

[0086] The sensor can be one of or the combination of the following: a mechanical switch, a Hall-effect sensor, an accelerometer.

[0087] The mechanical switch, hall-effect sensor, or accelerometer can be used for detection of the insertion of the medicament delivery member into an injection port.

[0088] The accelerometer can be used for detecting medicament delivery events.

[0089] Possible wireless communication methods include Bluetooth and Cellular Networks.

[0090] Bluetooth connectivity requires a smart device to transmit the stored data to the network and it requires a pairing action between the pad and the smart device before being able to use the supporting pad in case of 2-way connection. But it’s a cheaper alternative and it requires less space on PCB. A i-way connection does not require pairing.

[0091] The cellular network does not require any pairing process, it can be used as a plug-n-play device, no prior setup is needed, but it’s more expensive and it requires more space on PCB. Depending on the requirements of the product any of those two technologies can be used.

[0092] The processing units, e.g. the previously mentioned control unit 42, may comprise processing circuitry, logic circuit and / or further control units, including a microprocessor, microcontroller, programmable digital signal processor or another programmable device. The processing circuitry may also, or instead, each include an application specific integrated circuit, a programmable gate array or programmable array logic, a programmable logic device, or a digital signal processor. Where the processing circuitry includes a programmable device such as the microprocessor, microcontroller or programmable digital signal processor mentioned above, the processor may further include computer executable code that controls operation of the programmable device.

[0093] The delivery devices described herein can be used for the treatment and / or prophylaxis of one or more of many different types of disorders.

[0094] Exemplary disorders include, but are not limited to: rheumatoid arthritis, inflammatory bowel diseases (e.g. Crohn’s disease and ulcerative colitis), hypercholesterolaemia and / or dyslipidemia, cardiovascular disease, diabetes (e.g. type 1 or 2 diabetes), psoriasis, psoriatic arthritis, spondyloarthritis, hi dradenitis suppurativa, Sjogren's syndrome, migraine, cluster headache, multiple sclerosis, neuromyelitis optica spectrum disorder, anaemia, thalassemia, paroxysmal nocturnal hemoglobinuria, hemolytic anaemia, hereditary angioedema, systemic lupus erythematosus, lupus nephritis, myasthenia gravis, Behqet's disease, hemophagocytic lymphohistiocytosis, atopic dermatitis, retinal diseases (e.g., age-related macular degeneration, diabetic macular edema), uveitis, infectious diseases, bone diseases (e.g., osteoporosis, osteopenia), asthma, chronic obstructive pulmonary disease, thyroid eye disease, nasal polyps, transplant, acute hypoglycaemia, obesity, anaphylaxis, allergies, sickle cell disease, Alzheimer’s disease, Parkinson’s disease, dementia with Lewy bodies, systemic infusion reactions, immunoglobulin E (IgE)-mediated hypersensitivity reactions, cytokine release syndrome, immune deficiencies (e.g., primary immunodeficiency, chronic inflammatory demyelinating polyneuropathy), enzyme deficiencies (e.g., Pompe disease, Fabry disease, Gaucher disease), growth factor deficiencies, hormone deficiencies, coagulation disorders (e.g., hemophilia, von Willebrand disease, Factor V Leiden), and cancer.

[0095] Exemplary types of drugs that could be included in the delivery devices described herein include, but are not limited to, small molecules, hormones, cytokines, blood products, enzymes, vaccines, anticoagulants, immunosuppressants, antibodies, antibody-drug conjugates, neutralizing antibodies, reversal agents, radioligand therapies, radioisotopes and / or nuclear medicines, diagnostic agents, bispecific antibodies, proteins, fusion proteins, peptibodies, polypeptides, pegylated proteins, protein fragments, nucleotides, protein analogues, protein variants, protein precursors, protein derivatives, chimeric antigen receptor T cell therapies, cell or gene therapies, oncolytic viruses, or immunotherapies.

[0096] Exemplary drugs that could be included in the delivery devices described herein include, but are not limited to, immuno-oncology or biooncology medications such as immune checkpoints, cytokines, chemokines, clusters of differentiation, interleukins, integrins, growth factors, coagulation factors, enzymes, enzyme inhibitors, retinoids, steroids, signaling proteins, pro-apoptotic proteins, anti-apoptotic proteins, T-cell receptors, B-cell receptors, or costimulatory proteins.

[0097] Exemplary drugs that could be included in the delivery devices described herein include, but are not limited to, those exhibiting a proposed mechanism of action, such as human epidermal growth factor receptor 2 (HER-2) receptor modulators, interleukin (IL) modulators, interferon (IFN) modulators, complement modulators, glucagon-like peptide-i (GLP-i) modulators, glucose-dependent insulinotropic polypeptide (GIP) modulators, cluster of differentiation 38 (CD38) modulators, cluster of differentiation 22 (CD22) modulators, Ci esterase modulators, bradykinin modulators, C-C chemokine receptor type 4 (CCR4) modulators, vascular endothelial growth factor (VEGF) modulators, B-cell activating factor (BAFF), P-selectin modulators, neonatal Fc receptor (FcRn) modulators, calcitonin gene-related peptide (CGRP) modulators, epidermal growth factor receptor (EGFR) modulators, cluster of differentiation 79B (CD79B) modulators, tumor- associated calcium signal transducer 2 (Trop-2) modulators, cluster of differentiation 52 (CD52) modulators, B-cell maturation antigen (BCMA) modulators, enzyme modulators, platelet-derived growth factor receptor A (PDGFRA) modulators, cluster of differentiation 319 (CD319 or SLAMF7) modulators, programmed cell death protein 1 and programmed death-ligand 1 (PD-1 / PD-L1) inhibitors / modulators, B-lymphocyte antigen cluster of differentiation 19 (CD19) inhibitors, B-lymphocyte antigen cluster of differentiation 20 (CD20) modulators, cluster of differentiation 3 (CD3) modulators, cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) inhibitors, T-cell immunoglobulin and mucin-domain containing-3 (TIM-3) modulators, T cell immunoreceptor with Ig and ITIM domains (TIGIT) modulators, V-domain Ig suppressor of T cell activation (VISTA) modulators, indoleamine 2,3-dioxygenase (IDO or INDO) modulators, poliovirus receptor-related immunoglobulin domain-containing protein (PVRIG) modulators, lymphocyte-activation gene 3 (LAG3; also known as cluster of differentiation 223 or CD223) antagonists, cluster of differentiation 276 (CD276 or B7-H3) antigen modulators, cluster of differentiation 47 (CD47) antagonists, cluster of differentiation 30 (CD30) modulators, cluster of differentiation 73 (CD73) modulators, cluster of differentiation 66 (CD66) modulators, cluster of differentiation W137 (CDW137) agonists, cluster of differentiation 158 (CD158) modulators, cluster of differentiation 27 (CD27) modulators, cluster of differentiation 58 (CD58) modulators, cluster of differentiation 80 (CD80) modulators, cluster of differentiation 33 (CD33) modulators, cluster of differentiation 159 (CD159 or NKG2) modulators, glucocorticoid-induced TNFR-related (GITR) protein modulators, Killer Ig- like receptor (KIR) modulators, growth arrest-specific protein 6 (GAS6) / AXL pathway modulators, A proliferation-inducing ligand (APRIL) receptor modulators, human leukocyte antigen (HLA) modulators, epidermal growth factor receptor (EGFR) modulators, B-lymphocyte cell adhesion molecule modulators, cluster of differentiation W123 (CDW123) modulators, Erbb2 tyrosine kinase receptor modulators, endoglin modulators, mucin modulators, mesothelin modulators, hepatitis A virus cellular receptor 2 (HAVCR2) antagonists, cancer-testis antigen (CTA) modulators, tumor necrosis factor receptor superfamily, member 4 (TNFRSF4 or 0X40) modulators, adenosine receptor modulators, inducible T cell co-stimulator (ICOS) modulators, cluster of differentiation 40 (CD40) modulators, tumorinfiltrating lymphocytes (TIL) therapies, or T-cell receptor (TCR) therapies.

[0098] Exemplary drugs that could be included in the delivery devices described herein include, but are not limited to: etanercept, abatacept, adalimumab, evolocumab, exenatide, secukinumab, erenumab, galcanezumab, fremanezumab-vfrm, alirocumab, methotrexate (amethopterin), tocilizumab, interferon beta-ia, interferon beta-ib, peginterferon beta-ia, sumatriptan, darbepoetin alfa, belimumab, sarilumab, semaglutide, dupilumab, reslizumab, omalizumab, glucagon, epinephrine, naloxone, insulin, amylin, vedolizumab, eculizumab, ravulizumab, crizanlizumab-tmca, certolizumab pegol, satralizumab, denosumab, romosozumab, benralizumab, emicizumab, tildrakizumab, ocrelizumab, ofatumumab, natalizumab, mepolizumab, risankizumab-rzaa, ixekizumab, and immune globulins.

[0099] Exemplary drugs that could be included in the delivery devices described herein may also include, but are not limited to, oncology treatments such as ipilimumab, nivolumab, pembrolizumab, atezolizumab, durvalumab, avelumab, cemiplimab, rituximab, trastuzumab, ado- trastuzumab emtansine, fam-trastuzumab deruxtecan-nxki, pertuzumab, transtuzumab-pertuzumab, alemtuzumab, belantamab mafodotin-blmf, bevacizumab, blinatumomab, brentuximab vedotin, cetuximab, daratumumab, elotuzumab, gemtuzumab ozogamicin, 90-Yttrium- ibritumomab tiuxetan, isatuximab, mogamulizumab, moxetumomab pasudotox, obinutuzumab, ofatumumab, olaratumab, panitumumab, polatuzumab vedotin, ramucirumab, sacituzumab govitecan, tafasitamab, or margetuximab. Exemplary drugs that could be included in the delivery devices described herein include “generic” or biosimilar equivalents of any of the foregoing, and the foregoing molecular names should not be construed as limiting to the “innovator” or “branded” version of each, as in the nonlimiting example of innovator medicament adalimumab and biosimilars such as adalimumab-afzb, adalimumab-atto, adalimumab-adbm, and adalimumab-adaz.

[0100] Exemplary drugs that could be included in the delivery devices described herein also include, but are not limited to, those used for adjuvant or neoadjuvant chemotherapy, such as an alkylating agent, plant alkaloid, antitumor antibiotic, antimetabolite, or topoisomerase inhibitor, enzyme, retinoid, or corticosteroid. Exemplary chemotherapy drugs include, by way of example but not limitation, 5-fluorouracil, cisplatin, carboplatin, oxaliplatin, doxorubicin, daunorubicin, idarubicin, epirubicin, paclitaxel, docetaxel, cyclophosphamide, ifosfamide, azacitidine, decitabine, bendamustine, bleomycin, bortezomib, busulfan, cabazitaxel, carmustine, cladribine, cytarabine, dacarbazine, etoposide, fludarabine, gemcitabine, irinotecan, leucovorin, melphalan, methotrexate, pemetrexed, mitomycin, mitoxantrone, temsirolimus, topotecan, valrubicin, vincristine, vinblastine, or vinorelbine.

[0101] Exemplary drugs that could be included in the delivery devices described herein also include, but are not limited to, analgesics (e.g., acetaminophen), antipyretics, corticosteroids (e.g. hydrocortisone, dexamethasone, or methylprednisolone), antihistamines (e.g., diphenhydramine or famotidine), antiemetics (e.g., ondansetron), antibiotics, antiseptics, anticoagulants, fibrinolytics (e.g., recombinant tissue plasminogen activator [r-TPA]), antithrombolytics, or diluents such as sterile water for injection (SWFI), 0.9% Normal Saline, 0.45% normal saline, 5% dextrose in water, 5% dextrose in 0.45% normal saline, Lactated Ringer’s solution, Heparin Lock Flush solution, 100 U / mL Heparin Lock Flush Solution, or 5000 U / mL Heparin Lock Flush Solution. Pharmaceutical formulations including, but not limited to, any drug described herein are also contemplated for use in the delivery devices described herein, for example pharmaceutical formulations comprising a drug as listed herein (or a pharmaceutically acceptable salt of the drug) and a pharmaceutically acceptable carrier. Such formulations may include one or more other active ingredients (e.g., as a combination of one or more active drugs), or may be the only active ingredient present, and may also include separately administered or co-formulated dispersion enhancers (e.g. an animal-derived, human-derived, or recombinant hyaluronidase enzyme), concentration modifiers or enhancers, stabilizers, buffers, or other excipients.

[0102] Exemplary drugs that could be included in the delivery devices described herein include, but are not limited to, a multi-medication treatment regimen such as AC, Dose-Dense AC, TCH, GT, EC, TAC, TC, TCHP, CMF, FOLFOX, mF0LF0X6, mFOLFOXy, FOLFCIS, CapeOx, FLOT, DCF, FOLFIRI, FOLFIRINOX, FOLFOXIRI, IROX, CHOP, R-CHOP, RCHOP-21, Mini- CHOP, Maxi-CHOP, VR-CAP, Dose-Dense CHOP, EPOCH, Dose-Adjusted EPOCH, R-EPOCH, CODOX-M, IVAC, HyperCVAD, R-HyperCVAD, SC- EPOCH-RR, DHAP, ESHAP, GDP, ICE, MINE, CEPP, CDOP, GemOx, CEOP, CEPP, CHOEP, CHP, GCVP, DHAX, CALGB 8811, HIDAC, MOpAD, 7 + 3, 5 +2, 7 + 4, MEC, CVP, RBAC500, DHA-Cis, DHA-Ca, DHA-Ox, RCVP, RCEPP, RCEOP, CMV, DDMVAC, GemFLP, ITP, VIDE, VDC, VAI, VDC-IE, MAP, PCV, FCR, FR, PCR, HDMP, OFAR, EMA / CO, EMA / EP, EP / EMA, TP / TE, BEP, TIP, VIP, TPEx, ABVD, BEACOPP, AVD, Mini-BEAM, IGEV, C- MOPP, GCD, GEMOX, CAV, DT-PACE, VTD-PACE, DCEP, ATG, VAC, VelP, OFF, GTX, CAV, AD, MAID, AIM, VAC-IE, ADOC, or PE.

[0103] The inventive concept has mainly been described above with reference to a few examples. However, as is readily appreciated by a person skilled in the art, other embodiments than the ones disclosed above are equally possible within the scope of the inventive concept, as defined by the appended claims.

Claims

CLAIMS1. A medicament delivery device (1) comprising a medicament container (2), the medicament container having a proximal end (2a) and a distal end (2b) and the medicament container comprising a medicament delivery member (3) having a proximal end (3a), the medicament delivery device comprising:- a power module (4) having a plunger rod (5) configured to act on the medicament container to expel medicament via the proximal end of the medicament delivery member,- a drive unit (41) configured to move the plunger rod in the proximal direction,- a user interface (13) including a pause control element (14) arranged to manually control a pause state for the movement of the plunger rod in the proximal direction,- a control unit (42) configured to:- initiate a pre-inj ection state, and- initiate an injection state and thereby moving the plunger rod in the proximal direction, wherein the pause state of the plunger rod is enabled during the pre-inj ection state and disabled at the initiation of the injection state.

2. The medicament delivery device according to claim 1, wherein the preinjection state is a priming state, and the control unit is configured to initiate a priming state by moving the plunger rod in the proximal direction.

3. The medicament delivery device according to claim 2, wherein the control unit is configured to determine an end-of-priming state when the plunger rod has reached a predetermined position, in which end-of priming state the plunger rod is held in a fixed position.

4. The medicament delivery device according to claim 3, wherein the control unit is configured to disable the pause state upon determination of the end-of-priming state or wherein the control unit is configured to disable the pause state when the end-of-priming state and one or more additional predetermined conditions are met.

5. The medicament delivery device according to any of claims 2 to 4, wherein the control unit is configured to define an end-of-priming state based on that the plunger rod has moved a predetermined distance in the proximal direction.

6. The medicament delivery device according to claim 5, wherein the medicament delivery member comprises a flexible tube (8) fluidly connected to the medicament container and a needle (9) attached to the flexible tube, and wherein the predetermined distance is determined based on the maximum foreseeable air volume in the medicament container, the flexible tube and the needle, all combined.

7. The medicament delivery device according to any of claims 2, 3 and 6, wherein the medicament delivery device comprises an electronic tag (10), the electronic tag (10) being provided with information of the predetermined distance when combined with claim 6 or with information of the predetermined position when combined with claims 2 or 3.

8. The medicament delivery device according to any one of claims 3 to 5, wherein the control unit is configured to define the end-of-priming state in response to that the plunger rod has moved in the proximal direction and exceeded a predetermined force level required to move the plunger rod in the proximal direction.

9. A method for delivering a medicament with a medicament delivery device (1), the medicament delivery device comprising a medicament container (2), the medicament container having a proximal end (2a) and a distal end (2b), the medicament container comprising a medicament delivery member (3) having a proximal end (3a), the medicament delivery devicecomprising a power module (4) comprising a plunger rod (5) configured to act on the medicament container to expel medicament via the proximal end of the medicament delivery member and a drive unit (41) configured to move the plunger rod in a proximal direction and a control unit (42) configured to instruct the drive unit to move the plunger rod in the proximal direction, the medicament delivery device further comprising a user interface (13) including a pause control element (14) arranged to manually control a pause state for the movement of the plunger rod in the proximal direction, the method comprising;- Initiating (S10), by the control unit, a pre-injection state, and- Initiating (S30), by the control unit, an injection state and thereby moving the plunger rod in the proximal direction, wherein the pause state of the plunger rod is enabled during the pre-injection state and disabled (S20) at the initiation of the injection state.

10. The method for delivering a medicament according to claim 9, wherein the pre-injection state is a priming state and wherein the method includes initiating a priming state by moving the plunger rod in the proximal direction.

11. The method for delivering a medicament according to claim 10, wherein the method includes determining (Sioa) by the control unit an end-of- priming state when the plunger rod has reached a predetermined position in which end-of priming state the plunger rod is held in a fixed position.

12. The method for delivering a medicament according to claim 11, wherein the pause state is disabled by the control unit when the end-of-priming state has been determined or wherein the pause state is disabled when the end-of- priming state and one or more additional predetermined conditions are met.

13. The method for delivering a medicament according to claim 11 or 12, wherein the end-of-priming state is defined in response to that the plunger rod has moved a predetermined distance in the proximal direction.14- The method for delivering a medicament according claim 13, wherein the medicament delivery member comprises a flexible tube (8) fluidly connected to the medicament container and a needle (9) attached to the flexible tube, and wherein the predetermined distance is determined based on the maximum foreseeable air volume in the medicament container, the flexible tube and the needle, all combined.

15. A computer program product comprising program code for performing, when executed by the processing circuitry, the method of any of claims 9 to

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