Medicament delivery device for delivering a medicament

Abstract

The present disclosure relates to a medicament delivery device (2), the medicament delivery device comprising - a plunger rod (3) configured to expel medicament via the medicament delivery member (2), - a stepper motor (4) configured to act on the plunger rod (3) to expel the medicament, - a control unit (6) configured to: · drive the stepper motor in a burst of microsteps, the burst of microsteps corresponding to one full motor step, · place the stepper motor in a power-off period, and · repeat the previous steps in a cyclic pattern.

Description

[0001] METHOD FOR DELIVERYING A MEDICAMENT WITH A 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, and today there are a variety of injection devices available, including pen injectors, autoinjectors, and on-body devices. These devices have significantly improved the management of numerous medical conditions. However, current technology still has some limitations.

[0006] Electromechanical medical devices for medicament administration typically involve an electrical signal that creates mechanical movement. These systems offer several advantages, such as delivering precise and accurate doses. They can automate the medicament delivery process, and many can be programmed to administer medication at specific times. Additionally, many electromechanical devices can be monitored and controlled remotely.

[0007] Electromechanical injection devices typically use small motors or actuators to drive the injection mechanism. These components require a sufficient power supply to function correctly, which is provided by the device's battery. If the battery capacity is insufficient, it can lead to an inadequate power supply, affecting the motor's ability to deliver precise doses. In addition to motors, these devices often have electronic control systems that manage dosing accuracy, user interfaces, safety checks, and other functions, all of which require battery power.

[0008] Thus, battery capacity can be a limiting factor for electromechanical injection devices because it directly impacts their functionality, reliability, and user convenience. Adequate battery capacity ensures that these devices can consistently deliver accurate doses while remaining portable and user- friendly.

[0009] Recognizing these challenges, the applicant has identified several potential improvements that could enhance the medicament delivery devices available on the market today. These developments are detailed below.

[0010] SUMMARY

[0011] 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.

[0012] There is hence provided a method for delivering a medicament with a medicament delivery device, the medicament delivery device comprising a stepper motor, a control unit, a plunger rod and a medicament delivery member, the stepper motor being configured to act on the plunger rod to expel medicament via the medicament delivery member, and the control unit being configured to drive the stepper motor, the method comprising the steps:

[0013] - driving, by the control unit, the stepper motor in a burst of microsteps, the burst of microsteps corresponding to one full motor step,

[0014] - placing, by the control unit, the stepper motor in a power-off period, and

[0015] - repeating, by the control unit, the previous steps in a cyclic pattern.

[0016] Stepper motors are electromechanical devices that convert electrical pulses into discrete mechanical movements, allowing precise control of position and speed. They facilitate simple and accurate control of rotation angle and speed. Microstepping is a technique used to increase the resolution and smoothness of stepper motors by dividing each full step into smaller, fractional steps through precise current control in the motor windings. This technique enables finer positioning and reduces vibration, enhancing the performance of applications requiring accurate and smooth motion control. The stepper motor according to the present disclosure maybe a bipolar motor with two windings. Stepper motors may be operated in a continuous sinusoidal mode. When the stepper motor is operated in a continuous sinusoidal mode, microstepping pulses are evenly distributed over the injection length, with the motor powered continuously. The battery capacity that supplies current to the stepper motor may be a limitation, especially for high- volume injection scenarios, affecting the operation of the medicament delivery device.

[0017] Since the method according to the present disclosure includes to drive the stepper motor in a microstepping mode and wherein the motor is placed in a power-off period between each full step, the stepper motor may run within its ideal speed range during the bursts of microsteps and the power is additionally saved during the power-off periods which require less energy and also leads to a reduced heat generation. By applying voltage to the motor windings only during a short period, the stepper motor is thus powered just enough to advance one step at a time. This saves energy, reduces the power dissipation, and extends significantly the injection time between two occasions of battery charging.

[0018] In the present disclosure, the cyclic pattern thus includes sending step pulses in bursts and chopping the motor current in sections and allowing power-off periods in between each full step.

[0019] 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. 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.

[0022] Similarly, the terms “transverse”, “transversal” and “transversally” refer to a direction generally perpendicular to the longitudinal direction.

[0023] 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.

[0024] 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.

[0025] According to one embodiment, the plunger rod is a lead screw driven plunger rod.

[0026] According to one embodiment, the stepper motor comprises a screw assembly. In one example, the screw assembly comprises a lead screw, and anti-rotator provided at a distal end of the lead crew and a magnetic mutter provided around the screw at its proximal end. The magnetic mutter rotates around the screw. The anti-rotator prevents the screw from rotating and due to the rotation of the stepper motor, the screw moves back and forth and thereby transforms rotational movement and torque to linear movement and force. The screw assembly pushes against the plunger rod and thereby expels medicament from a medicament container via the medicament delivery member.

[0027] According to one embodiment, the number of microsteps in each full motor step in the cyclic pattern is the same. Alternatively, the number of microsteps in at least 3, or at least 4, or at least 10, consecutive cycles in the cyclic pattern is the same. The fact that the number of microsteps in each full motor steps is the same ensures a consistent resolution across the motor’s entire range of motion. This uniformity allows for predictable and precise positioning, provides for a smoother motion and a simplified control.

[0028] According to one embodiment, the number of microsteps in each full motor step is 32. This has been found by the present inventors, in the context of the present invention, to imitate a sinus curve and provide an enhanced and smooth movement of the stepper motor.

[0029] According to one embodiment, the numbers of cycles repeated in the cyclic pattern is 10 or more. The number of cycles repeated in the cyclic pattern maybe 20 or more, or 48 or more.

[0030] According to one embodiment, the cyclic pattern at least corresponds to one complete revolution of the stepper motor, i.e. a complete 360-degree rotation of the stepper motor. The complete revolution consists of a specific number of full motor steps, depending on the motor’s step angle.

[0031] According to one embodiment, the cyclic pattern continues throughout the entire injection time. The total injection time may involve multiple complete revolutions of the stepper motor.

[0032] According to one embodiment, the method comprises a step of setting, by the control unit, a duration of the respective power-off period in the cyclic pattern, such that the accumulated duration of the respective power-off period is determined based on a set total injection time. Hence, the burst period may be hard coded and having fixed length while the duration of the power-off periods in the cyclic pattern are extended for injections with longer durations compared to injections with shorter duration. As a comparison, in a continuous sinus mode, the whole sinus will be stretched when extending the injection time. This means that power saving gains with the method according to the present disclosure will improve as injection time gets longer.

[0033] According to one embodiment, the duration of the respective power-off period within the cyclic pattern is the same, meaning that each of the power- off periods within the cyclic pattern has the same duration.

[0034] According to an alternative embodiment, the duration of the respective power-off period varies between the power-off periods within the cyclic pattern, i.e. such that the duration of at least some of the power-off periods differs from the other power-off periods within the cyclic pattern.

[0035] According to one embodiment, the step of setting, by the control unit, the duration of the respective power-off periods period in the cyclic pattern, such that the accumulated duration of the respective power-off period is determined based on the set total injection time is a pre-step, carried out prior to initiating the cyclic pattern.

[0036] According to one embodiment, the step of setting, by the control unit, the duration of the respective power-off periods period in the cyclic pattern, such that the accumulated duration of the respective power-off period is determined based on the set total injection time, is carried out during the cyclic pattern. For example, this step maybe an adjustment step, carried out during the cyclic pattern, of adjusting the duration of the power-off periods in the cyclic pattern based on the set total injection time.

[0037] According to one embodiment, the method comprises the pre-step of setting, by the control unit, the duration of the respective power-off period in the cyclic pattern, such that the accumulated duration of the respective power-off period is determined based on a set total injection time, and the step of adjusting the duration of the respective power-off periods period in the cyclic pattern, if needed. According to one embodiment, the set total injection time is above 7 minutes.

[0038] According to one embodiment, the set total injection time is within the range of from 7 minutes to 10 hours. The present invention is partly directed towards high-volume injection states, i.e. within the range of from 7 minutes to 10 hours, which are extended in duration due the limited capacity of the human tissue to accommodate fluids. The absorption rate at which fluids are absorbed by tissue is relatively slow and a rapid injection of a large volume may lead to pooling of fluid at the injection site. Hence, injecting large volume too quickly can cause discomfort, pain or even tissue damage. Furthermore, more viscous liquids, such as certain medications or solutions, require more time to inject because they flow less easily through the syringe and needle.

[0039] According to one embodiment, the medicament delivery member comprises a power unit comprising a battery / batteries, an electronic circuitry and the stepper motor. The stepper motor may form part of a drive unit being docketed into the power unit. The power unit may furthermore comprise the plunger rod, configured to act on the medicament container to expel medicament via the medicament delivery device.

[0040] According to a second aspect of the present disclosure, there is provided a medicament delivery device comprising a medicament delivery member, the medicament delivery device comprising:

[0041] - a plunger rod configured to expel medicament via the medicament delivery member,

[0042] - a stepper motor configured to act on the plunger rod to expel medicament,

[0043] - a control unit configured to: o driving, by the control unit, the stepper motor in a burst of microsteps, the burst of microsteps corresponding to a full motor step, o placing, by the control unit, the stepper motor in a power-off period, and o repeating, by the control unit, the previous steps in a cyclic pattern.

[0044] 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.

[0045] According to one embodiment, the plunger rod is a lead screw driven rod.

[0046] According to one embodiment, the stepper motor comprises a screw assembly. In one example, the screw assembly comprises a lead screw, and anti-rotator provided at a distal end of the lead crew and a magnetic mutter provided around the screw at its proximal end. The magnetic mutter rotates around the screw. The anti-rotator prevents the screw from rotating and due to the rotation of the stepper motor, the screw moves back and forth and thereby transforms rotational movement and torque to linear movement and force. The screw assembly pushes against the plunger rod and thereby expels medicament from a medicament container via the medicament delivery member.

[0047] According to one embodiment, the number of microsteps in each full motor step in the cyclic pattern is the same. Alternatively, the number of microsteps in at least 3, or at least 4, or at least 10, consecutive cycles in the cyclic pattern is the same. The fact that the number of microsteps in each full motor steps is the same ensures a consistent resolution across the motor’s entire range of motion. This uniformity allows for predictable and precise positioning, provides for a smoother motion and a simplified control.

[0048] According to one embodiment, the number of microsteps in each full motor step in the cyclic pattern is 32. This has been found by the present inventors, in the context of the present invention, to imitate a sinus curve and provide an enhanced and smooth movement of the stepper motor. According to one embodiment, the numbers of cycles repeated in the cyclic pattern is io or more. The number of cycles repeated in the cyclic pattern maybe 20 or more, or 48 or more.

[0049] According to one embodiment, the cyclic pattern at least corresponds to one complete revolution of the stepper motor, i.e. a complete 360-degree rotation of the stepper motor. The complete revolution consists of a specific number of full motor steps, depending on the motor’s step angle.

[0050] According to one embodiment, the cyclic pattern continues throughout the entire injection time. The total injection time may involve multiple complete revolutions of the stepper motor.

[0051] According to one embodiment, the control unit is configured of setting a duration of the respective power-off period in the cyclic pattern, such that the accumulated duration of the respective power-off period is determined based on a set total injection time. The duration of the power-off period, based on a set total injection time, is set prior to initiating the cyclic pattern of motor steps and power-off periods. Hence, the burst period maybe hard coded and having fixed length while the duration of the power-off periods in the cyclic pattern are extended for injections with longer durations compared to injections with shorter duration. As a comparison, in a continuous sinus mode, the whole sinus will be stretched when extending the injection time. This means that power saving gains with the medicament delivery device according to the second aspect of the present disclosure will improve as injection time gets longer.

[0052] According to one embodiment, the duration of the respective power-off period within the cyclic pattern is the same, meaning that each of the power- off periods within the cyclic pattern has the same duration.

[0053] According to an alternative embodiment, the duration of the respective power-off period varies between the power-off periods within the cyclic pattern, i.e. such that the duration of at least some of the power-off periods differs from the other power-off periods within the cyclic pattern.

[0054] According to one embodiment, the control unit is configured to, prior to initiating the cyclic pattern, set the duration of the respective power-off period in the cyclic pattern, such that the accumulated duration of the respective power-off period is determined based on the set total injection time.

[0055] According to one embodiment, the control unit is configured to, during the cyclic pattern, set the duration of the respective power-off period in the cyclic pattern, such that the accumulated duration of the respective power-off period is determined based on the set total injection time. For example, the control unit may be configured to adjust, if needed, the accumulated duration of the respective power-off periods in the cyclic pattern based on the set total injection time.

[0056] According to one embodiment the control unit is configured to, prior to initiating the cyclic pattern, set the duration of the respective power-off period in the cyclic pattern, such that the accumulated duration of the respective power-off period is determined based on the set total injection time, and during the cyclic pattern, adjusting, if needed, the duration of the respective power-off periods period in the cyclic pattern.According to one embodiment, the set total injection time is above 7 minutes.

[0057] According to one embodiment, the set total injection time is within the range of from 7 minutes to 10 hours. The present invention is partly directed towards high-volume injection states, i.e. within the range of from 7 minutes to 10 hours, which are extended in duration due the limited capacity of the human tissue to accommodate fluids. The absorption rate at which fluids are absorbed by tissue is relatively slow and a rapid injection of a large volume may lead to pooling of fluid at the injection site. Hence, injecting large volume too quickly can cause discomfort, pain or even tissue damage. Furthermore, more viscous liquids, such as certain medications or solutions, require more time to inject because they flow less easily through the syringe and needle.

[0058] According to one embodiment, the medicament delivery device comprises a power module comprising the stepper module and the plunger rod. The stepper motor may form part of a drive unit being docketed into the power unit. The power module may furthermore comprise a battery / batteries and electronic circuitry.

[0059] According to one embodiment, the medicament delivery device may comprise a disposable cassette accommodating a medicament container.

[0060] 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.

[0061] According to one embodiment, the power module comprises a proximal receiving interface adapted to receive and connect to the disposable cassette.

[0062] According to a third aspect of the present disclosure, there is provided a system for controlling the movement of a stepper motor in a medicament delivery device, the stepper motor being configured to act on a plunger rod and the plunger rod being configured to expel medicament via a medicament delivery member, the system comprising:

[0063] - a control unit configured to: o driving, by the control unit, the stepper motor in a burst of microsteps, the burst of microsteps corresponding to a full motor step, o placing, by the control unit, the stepper motor in a power-off period, and o repeating, by the control unit, the previous steps in a cyclic pattern.

[0064] Effects and features of the third aspect are largely analogous to those described above in connection with the first and the second aspect. Embodiments mentioned in relation to the first and second aspects are largely compatible with the third aspect, and vice versa, of which some are exemplified below.

[0065] According to one embodiment, the number of microsteps in each full motor step in the cyclic pattern is the same. Alternatively, the number of microsteps in at least 3, or at least 4, or at least 10, consecutive cycles in the cyclic pattern is the same. The fact that the number of microsteps in each full motor steps is the same ensures a consistent resolution across the motor’s entire range of motion. This uniformity allows for predictable and precise positioning, provides for a smoother motion and a simplified control.

[0066] According to one embodiment, the number of microsteps in each full motor step in the cyclic pattern is 32. This has been found by the present inventors, in the context of the present invention, to imitate a sinus curve and provide an enhanced and smooth movement of the stepper motor.

[0067] According to one embodiment, the numbers of cycles repeated in the cyclic pattern is 10 or more. The number of cycles repeated in the cyclic pattern maybe 20 or more, or 48 or more.

[0068] According to one embodiment, the cyclic pattern at least corresponds to one complete revolution of the stepper motor, i.e. a complete 360-degree rotation of the stepper motor. The complete revolution consists of a specific number of full motor steps, depending on the motor’s step angle. According to one embodiment, the cyclic pattern continues throughout the entire injection time. The total injection time may involve multiple complete revolutions of the stepper motor.

[0069] According to one embodiment, the control unit is configured of setting a duration of the respective power-off period in the cyclic pattern, such that the accumulated duration of the respective power-off period is determined based on a set total injection time. The duration of the power-off period, based on a set total injection time, is set prior to initiating the cyclic pattern of motor steps and power-off periods. Hence, the burst period maybe hard coded and having fixed length while the duration of the power-off periods in the cyclic pattern are extended for injections with longer durations compared to injections with shorter duration. As a comparison, in a continuous sinus mode, the whole sinus will be stretched when extending the injection time. This means that power saving gains with the system according to the third aspect of the present disclosure will improve as injection time gets longer.

[0070] According to one embodiment, the duration of the respective power-off period within the cyclic pattern is the same, meaning that each of the power- off periods within the cyclic pattern has the same duration.

[0071] According to an alternative embodiment, the duration of the respective power-off period varies between the power-off periods within the cyclic pattern, i.e. such that the duration of at least some of the power-off periods differs from the other power-off periods within the cyclic pattern.

[0072] According to one embodiment, the control unit is configured to, prior to initiating the cyclic pattern, set the duration of the respective power-off period in the cyclic pattern, such that the accumulated duration of the respective power-off period is determined based on the set total injection time.

[0073] According to one embodiment, the control unit is configured to, during the cyclic pattern, set the duration of the respective power-off period in the cyclic pattern, such that the accumulated duration of the respective power-off period is determined based on the set total injection time. For example, the control unit may be configured to adjust, if needed, the accumulated duration of the respective power-off periods in the cyclic pattern based on the set total injection time.

[0074] According to one embodiment the control unit is configured to, prior to initiating the cyclic pattern, set the duration of the respective power-off period in the cyclic pattern, such that the accumulated duration of the respective power-off period is determined based on the set total injection time, and during the cyclic pattern, adjusting, if needed, the duration of the respective power-off periods period in the cyclic pattern. According to one embodiment, the set total injection time is above 7 minutes.

[0075] According to one embodiment, the set total injection time is within the range of from 7 minutes to 10 hours. The present invention is partly directed towards high-volume injection states, i.e. within the range of from 7 minutes to 10 hours, which are extended in duration due the limited capacity of the human tissue to accommodate fluids. The absorption rate at which fluids are absorbed by tissue is relatively slow and a rapid injection of a large volume may lead to pooling of fluid at the injection site. Hence, injecting large volume too quickly can cause discomfort, pain or even tissue damage. Furthermore, more viscous liquids, such as certain medications or solutions, require more time to inject because they flow less easily through the syringe and needle.

[0076] 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. BRIEF DESCRIPTION OF THE DRAWINGS

[0077] The specific embodiments of the inventive concept will now be described, by way of example, with reference to the accompanying drawings, in which:

[0078] Fig. 1 is a perspective view of a medicament delivery device according to embodiments of the present disclosure;

[0079] Fig. 2 is a perspective view of the medicament delivery device with housing removed according to embodiments of the present disclosure;

[0080] Fig. 3 is an exploded view of the medicament delivery device according to embodiments of the present disclosure;

[0081] Fig. 4 is a flowchart illustrating the steps of a method in according to embodiments of the present disclosure;

[0082] Fig. 4 is a graph illustrating a continuous sinus mode of driving a stepper motor; and

[0083] Fig. 6 is a graph illustrating the step-by-step mode of driving a stepper motor according to the present disclosure.

[0084] DETAILED DESCRIPTION

[0085] 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. Fig i shows an example of a medicament delivery device i such as an electromechanical injector according to embodiments of the present disclosure. The medicament delivery device i comprises a power module 7 connected to a disposable cassette 8. The power module 7 is comprised within a housing 9 and the disposable cassette comprises a cap 12 to protect a medicament container therein.

[0086] Fig. 2 is a perspective view of the medicament delivery device 1 shown in Fig. 1, with the housing 9 removed and Fig. 3 is an exploded view of a medicament delivery device 1 with the housing 9 removed.

[0087] As illustrated in Figs. 2 and 3, the power module 7 comprises a plunger rod 3 and a stepper motor 4. The plunger rod 3 is configured to expel medicament from a medicament container 11 via the medicament delivery member 2, to a user at a dose delivery site. In this example the medicament container 2 is embodied as a syringe, and the plunger rod 3 expels medicament from the syringe 2. Alternatively, the medicament container can be a cartridge or a collapsible bag. The medicament delivery member can be an injection needle, or a spray nozzle being fluidly connected to the medicament container upon expelling the medicament.

[0088] The stepper motor 4 may be a bipolar motor with two windings.

[0089] The stepper motor 4 in these figures includes electromagnets and a screwassembly 5. The screw assembly 5 comprises a lead screw 5a, an anti-rotator 5b provided at a distal end of the lead crew 5a, and a magnetic mutter 5c provided around the lead screw 5a at its proximal end. The magnetic mutter 5c rotates around the lead screw 5a. The anti-rotator 5b prevents the lead screw 5a from rotating. Due to the rotation of the stepper motor 4, the lead screw 5a moves back and forth and thereby transforms rotational movement and torque to linear movement and force. The screw assembly 5 pushes against the plunger rod 3 which expels medicament from the syringe 2.

[0090] The medicament delivery device 1 furthermore comprises a control unit 6 connected to the stepper motor 4. The control unit 6 is configured to drive the stepper motor 4 in a burst of microsteps, the burst of microsteps corresponding to a full motor step, then placing the stepper motor 4 in a power-off period, and subsequently repeating these two steps in a cyclic pattern. The voltage is thus applied to the motor windings of the stepper motor 4 only during a short period and the stepper motor 4 is thus powered just enough to advance one step at a time.

[0091] However, before initiating delivery of the medicament with the medicament delivery member 2 and during the period of time that the plunger rod 3 is advanced in a proximal direction until it reaches its position to initiate the injection, the stepper motor 4 may be operated in a continuous sinus mode. This is because the stepper motor may then run at its optimal speed without the need to consider the injection time.

[0092] The power module 7 comprises the housing 9 and the disposable cassette 8 comprises a tubular main body 10 accommodating the syringe 2. The disposable cassette 8 may comprise the cap 12 protecting the medicament delivery member 2. As shown in Figs. 1 - 3, the housing 9 may be divided in two parts, a first housing part 9a and a second housing part 9b, wherein the second housing part 9b is arranged distally of the first housing part 7a. In Figs. 2 and 3, the first and second housing parts 9a, 9b have been removed.

[0093] The disposable cassette 8 is typically adapted to accommodate medicament containers of different volumes, for example ranging from about 1 ml to about 50 ml.

[0094] The power module 7 may comprise an antenna 13 (or a set of antennas) and a power pack with electronic circuitry 14 and batteries 15, see Fig. 2. In Fig. 3 an internal chassis and the batteries have been removed to improve visibility.

[0095] Fig. 4 is a flow-chart describing steps of a method for delivering a medicament with medicament delivery device 1 as illustrated in Figs. 1 - 3, according to embodiments of the present disclosure. In a step Sio, the stepper motor is driven, by the control unit 6, using a burst of microsteps, with each burst corresponding to one full motor step. During this process, the control unit directs the stepper motor to move one full step by sending the current in a burst of step pulses. These step pulses represent the burst of microsteps that together achieve the full motor step.

[0096] In a subsequent step S20, the stepper motor is placed, by the control unit in a power-off period.

[0097] In a step S30, the previous steps are repeated, by the control unit 6, in a cyclic pattern. The motor current is thus chopped in sections, enabling power-off periods in between each full step by the stepper motor.

[0098] In an optional pre-step S5’, a duration of the respective power-off periods in the cyclic pattern is set, by the control unit 6, such that the accumulated duration of the respective power-off period is determined based on a set total injection time. The total injection time maybe above 7 minutes. Preferably, the total injection time maybe from above 7 minutes to 10 hours. This means that the duration of the power-off period is set depending on the set total injection time, i.e. for a longer duration injection, the power-off periods are longer, while the duration of the burst of microsteps remains the same irrespective of the duration of the injection.

[0099] In an optional step S5”, carried out during the cyclic pattern, a duration of the power-off periods is set, such that the accumulated duration of the respective power-off period is determined based on a set total injection time.

[0100] The method, as disclosed herein, may optionally comprise one of these two steps 5’, 5” or both two steps.

[0101] Fig. 5 illustrates the traditional “continuous sinus” way of driving a stepper motor, meaning that the step pulses are evenly distributed over the length of the injection, and the power to the stepper motor is on the whole time. The graph shown in Fig 5 illustrates one single period, i.e. a complete cycle of the waveform applied to the motor coils. Fig. 6 illustrates the method of driving the stepper motor in a step-by-step mode according to the present disclosure, including sending step pulses in bursts, thereby chopping the motor current in section, and allowing power- off periods “Off period” in between each full step “Burst period”. As in Fig. 5, the graph illustrated in Fig. 6 illustrates a single period.

[0102] 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 6) 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.

[0103] The sensor can be, but not limited to, one of or the combination of the following: a mechanical switch, a Hall-effect sensor, and / or an accelerometer.

[0104] Possible wireless communication methods include Bluetooth and Cellular Networks.

[0105] 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.

[0106] 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.

[0107] The processing units, e.g. the previously mentioned control unit 6, 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.

[0108] The delivery devices described herein can be used for the treatment and / or prophylaxis of one or more of many different types of disorders.

[0109] 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 i or 2 diabetes), psoriasis, psoriatic arthritis, spondyloarthritis, hidradenitis 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.

[0110] 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.

[0111] 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-apopt otic proteins, anti-apoptotic proteins, T-cell receptors, B-cell receptors, or costimulatory proteins.

[0112] 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 42 (CD42) 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 148 (CD148) modulators, cluster of differentiation 27 (CD27) modulators, cluster of differentiation 48 (CD48) modulators, cluster of differentiation 80 (CD80) modulators, cluster of differentiation 33 (CD33) modulators, cluster of differentiation 149 (CD149 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.

[0113] 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.

[0114] 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.

[0115] 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, 4-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.

[0116] 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, 0.44% normal saline, 4% dextrose in water, 4% dextrose in 0.44% normal saline, Lactated Ringer’s solution, Heparin Lock Flush solution, 100 U / mL Heparin Lock Flush Solution, or 4000 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.

[0117] 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, 4 +2, 7 + 4, MEC, CVP, RBAC400, 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.

[0118] 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

26CLAIMS1. A method for delivering a medicament with a medicament delivery device (1), the medicament delivery device comprising a stepper motor (4), a control unit (6), a plunger rod (3) and a medicament delivery member (2), the stepper motor being configured to act on the plunger rod (3) to expel medicament via the medicament delivery member, and the control unit (6) being configured to drive the stepper motor, the method comprising the steps:- driving (S10), by the control unit, the stepper motor in a burst of microsteps, the burst of microsteps corresponding to one full motor step,- placing (S20), by the control unit, the stepper motor in a power-off period, and- repeating (S30), by the control unit, the previous steps in a cyclic pattern.

2. The method according to claim, wherein the number of microsteps in each full motor step in the cyclic pattern is the same.

3. The method according to any one of claims 1 to 2, wherein the method comprises a step of4. (S4) setting, by the control unit, a duration of the respective power-off period in the cyclic pattern, such that the accumulated duration of the respective power-off period is determined based on a set total injection time. The method according to claim 3, wherein the step (S5) of setting, by the control unit, the duration of the power-off periods, such that the accumulated duration of the respective power-off period is determined based on a set total injection time is a pre-step (S5’), carried out prior to initiating the cyclic pattern.

5. The method according to claim 4 or 5, wherein the step (S5) of setting, by the control unit, the duration of the power-off periods such that the accumulated duration of the respective power-off period is determined basedon a set total injection time is a step (S5”) carried out during the cyclic pattern.

6. The method according to any one of claims 3 - 5, wherein the set total injection time is above 7 minutes.

7. A medicament delivery device (1) comprising a medicament delivery member (3), the medicament delivery device comprising:- a plunger rod (3) configured to expel medicament via the medicament delivery member (2),- a stepper motor (4) configured to act on the plunger rod (3) to expel medicament,- a control unit (6) configured to: o driving, by the control unit, the stepper motor in a burst of microsteps, the burst of microsteps corresponding to a full motor step, o placing, by the control unit, the stepper motor in a power-off period, and o repeating, by the control unit, the previous steps in a cyclic pattern.

8. The medicament delivery device according to claim 7, wherein the number of microsteps in each full motor step in the cyclic pattern is the same.

9. The medicament delivery device according to claim 7 or 8, wherein the control unit is configured to set a duration of the respective power-off period in the cyclic pattern, such that the accumulated duration of the respective power-off period is determined based on a set total injection time.

10. The medicament delivery device according to claim 9, wherein the control unit is configured to, prior to initiating the cyclic pattern, set the duration of the power-off periods based on the set total injection time.

11. The medicament delivery device according to claim 9 or 10, wherein the control unit is configured to, during the cyclic pattern, set the duration of the power-off periods based on the set total injection time.

12. The medicament delivery device according to any one of claims 10 to 12, wherein the set total injection time is above 7 minutes.

13. A system for controlling the movement of a stepper motor (4) in a medicament delivery device (1), the stepper motor being configured act on a plunger rod (3) and the fluid pump being configured to expel medicament via the medicament delivery member (2), the system comprising:- a control unit (6) configured to: o driving, by the control unit, the stepper motor in a burst of microsteps, the burst of microsteps corresponding to a full motor step, o placing, by the control unit, the stepper motor in a power-off period, and o repeating, by the control unit, the previous steps in a cyclic pattern.

14. The system according to claim 13, wherein the numbers of microsteps in each full motor step in the cyclic pattern is the same.

15. The system according to claims 14, wherein the control unit is configured to set a duration of the respective power-off period in the cyclic pattern, such that the accumulated duration of the respective power-off period is determined based on a set total injection time.

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