A method for automatically priming drug containers

Abstract

A method for automatically priming a drug container (13) housed in a disposable cassette (4) of a drug delivery device (1). The method includes: determining a first priming parameter which is the orientation of the drug delivery device (1) as determined by an accelerometer (84) (S10); determining a second priming parameter which is related to a physical act of moving a part of the drug delivery device (1) (S20); and performing automatic priming of the drug container (13) (S50) in response to satisfying a first priming criterion for the first priming parameter (S30) by identifying the position of the drug delivery device (1) housing the cassette (4) such that the proximal end (2a) of the drug delivery member (2) faces upward (S30a); and satisfying a second priming criterion for identifying the presence of the second priming parameter (S40) (S48).

Description

Technical Field

[0001] The present disclosure generally relates to medical devices for drug administration.

Background Art

[0002] Many medical conditions require injections. In recent years, there are a number of different injection devices, including various types of pen injectors, self-injectors, and on-body devices. Many of these devices have enabled significant improvements in the management of many medical conditions, but there are still various limitations in the current technology.

[0003] For example, a drug container holding a drug may contain air or gas trapped inside the drug container, which can interfere with or complicate drug administration. For example, in certain drug delivery devices, the drug container contains multiple doses of the drug, and it is important to administer an accurate amount of the drug in each dose. Air or gas trapped inside the drug container can result in an insufficient amount of the drug in at least one dose. There are also other reasons why it is desirable to remove air or gas before a drug delivery event. The drug container may undergo priming in which air or gas is removed before the drug delivery event.

[0004] In considering these problems, the applicant understands that various developments can be made to help improve currently commercially available drug delivery devices, and these developments are described in detail below.

Summary of the Invention

[0005] An object of the present disclosure is to provide a method for automatically priming a drug container housed within a disposable cassette of a drug delivery device that solves or at least mitigates the problems of the prior art.

[0006] Therefore, a method for automatically priming a drug container housed in a disposable cassette of a drug delivery device having a proximal and distal end, wherein the drug container comprises a drug delivery member having a proximal end, the drug delivery device comprises a power module having a plunger rod configured to act on the drug container to dispense a drug through the proximal end of the drug delivery member, a drive unit configured to move the plunger rod in the proximal direction, and an accelerometer for determining the orientation and acceleration of the drug delivery device, and the method is - Determining the first priming parameter, which is the orientation of the drug delivery device determined by the accelerometer, - Determining a second priming parameter related to the physical act of moving a portion of the drug delivery device, A method is provided which includes: performing automatic priming of a drug container by automatically moving a plunger rod in the proximal direction to act on the drug container and release air or gas through the proximal end of the drug delivery member, in response to satisfying a first priming criterion for a first priming parameter by identifying the position of a drug delivery device housing a cassette such that the proximal end of the drug delivery member faces upward, and satisfying a second priming criterion for identifying the presence of a second priming parameter.

[0007] Therefore, priming of the drug container can be achieved automatically and in an improved manner. Automatic priming of the drug container can be performed in an advantageous manner by providing a first priming parameter, a second priming parameter different from the first priming parameter, and conditions that satisfy a first priming criterion associated with the first priming parameter and a second priming criterion associated with the second priming parameter. More specifically, the first priming criterion is satisfied when the drug delivery device containing the cassette is identified, provided that the proximal end of the drug delivery member is positioned to face upward, and the second priming criterion is satisfied when a physical act that moves part of the drug delivery device 1 is identified, so that any air or gas trapped in the drug container is likely to move to a location near the drug delivery member 2, typically to the top of the drug container, and therefore may be discharged when the plunger rod moves proximal. For example, physical movement of part of the drug delivery device associated with the second priming criterion may cause an impact on the drug container, resulting in or at least increasing the likelihood of trapped air or gas moving towards the top of the drug container.

[0008] Using disposable cassettes, variable drug containers of different capacities can be used with the same power module. Therefore, the volume of the drug container can range from a small capacity of approximately 2 mL to a large capacity of approximately 10 mL or more, depending on the size of the disposable cassette. Regardless of the drug capacity, the engagement between the disposable cassette forming the drug delivery device and the power module remains the same. Throughout this application, the disposable cassette may simply be referred to as "cassette."

[0009] It should be noted that "air" should be interpreted broadly and may refer to any type of gas containing oxygen and / or nitrogen, typically bubbles or gas bubbles. Therefore, priming may be referred to as the act of discharging bubbles or gas bubbles from a drug container.

[0010] Where the term “distal direction” is used in this disclosure, it refers to the direction away from the dose delivery site during use of the drug delivery device. Where the term “distal portion / distal end” is used, it refers to the portion / end of the delivery device, or the portion / end of its component, that is located furthest from the dose delivery site during use of the drug delivery device.

[0011] In response to this, when the term "proximal direction" is used, it refers to the direction toward the dose delivery site during the use of a drug delivery device.

[0012] When the term "proximal portion / proximal end" is used, it refers to the portion / end of the drug delivery device, or the portion / end of its component, that is closest to the dose delivery site under the use of the drug delivery device.

[0013] Furthermore, the terms “longitudinal,” “axial,” or “axial” refer to a direction extending from the proximal end to the distal end, typically along the device or its components, in the direction of the longest elongation of the device and / or components.

[0014] Similarly, the terms “transverse direction,” “transverse,” and “in the transverse direction” refer to a direction that is generally perpendicular to the longitudinal direction.

[0015] Furthermore, the terms “circumferential,” “circumferential,” or “circumferential” refer to the circumference or circumferential direction relative to the axis, typically the central axis extending in the direction of the longest elongation of the device and / or component.

[0016] Similarly, "radial direction" or "radially" refers to a direction extending radially with respect to the axis, while "rotation," "rotational," and "rotating" refer to rotation with respect to the axis.

[0017] According to one embodiment, automatic priming is performed in response to the satisfaction of the first priming criterion before the satisfaction of the second priming criterion. This allows the cassette to be positioned and identified as positioned so that the proximal end of the drug delivery member faces upward, prior to the identification of the presence of a physical act that moves part of the drug delivery device, thereby automatically moving the plunger rod proximal to act on the drug container and improving the likelihood that trapped air or gas will move toward the top of the drug container before releasing air or gas through the proximal end of the drug delivery member. Typically, the first criterion is satisfied during or while the second criterion is being satisfied. Automatic priming of the drug container may be performed as a direct result of identifying that the first and second criteria are satisfied, for example, within one or two seconds after identifying that the second criterion is satisfied.

[0018] According to one embodiment, automatic priming is performed by moving a plunger rod to a predefined priming position using a drive unit. Thus, priming of the drug container can be performed in a predefined manner. For example, a sufficient amount of air or gas in the drug container, typically all of the trapped air or gas, may be released from the drug container via the drug delivery member during automatic priming, while only a small amount of the drug may be released. In other words, the amount of drug discharged from the drug container during automatic priming can be controlled by the predefined priming position of the plunger rod.

[0019] According to one embodiment, the predefined priming position corresponds to the volume of the drug container. That is, a specific volume of the drug container may correspond to a relevant predefined priming position of the plunger rod. This allows the predefined priming position of the plunger rod to be adapted to the volume of the drug container.

[0020] According to one embodiment, the method further includes using an accelerometer to identify a physical act that moves a portion of a drug delivery device, and a second priming parameter is defined by such identification. Thus, a second priming parameter relating to a physical act that moves a portion of a drug delivery device may be defined as a physical act that moves a portion of a drug delivery device detected by an accelerometer. In other words, a physical act that moves a portion of a drug delivery device may be of a nature that an accelerometer can detect. For example, the sensitivity of the accelerometer is adapted accordingly. For example, the sensitivity of the accelerometer is adapted to detect a physical act that moves a portion of a drug delivery device that causes a shock to the drug container, resulting in or at least increasing the possibility of trapped air or gas moving toward the top of the drug container.

[0021] According to one embodiment, a physical act that moves a portion of a drug delivery device as identified by an accelerometer is repeated tapping of or on the drug delivery device. Therefore, a second priming parameter related to a physical act that moves a portion of a drug delivery device can be defined as a physical act that moves a portion of a drug delivery device as detected by an accelerometer, such as tapping of or on the drug delivery device. Such repeated tapping is an example of a physical act that moves a portion of a drug delivery device that causes an impact on the drug container, resulting in or at least increasing the likelihood of trapped air or gas moving towards the top of the drug container. A physical act that moves a portion of a drug delivery device could be, for example, a physical act that moves the drug container itself, such as tapping the drug container against a hard surface, or a physical act that taps the drug delivery device with a finger.

[0022] According to one embodiment, the repetitive tapping of or on the drug delivery device includes at least three consecutive taps. Thus, the physical action increases the likelihood that the trapped air or gas will move toward the top of the drug container. In such an example, the plunger rod is typically moved by the drive unit after the last tap of at least three consecutive taps.

[0023] According to one embodiment, the disposable cassette is equipped with a cap protecting the drug delivery component, and the physical act of moving a portion of the drug delivery device, as identified by the accelerometer, is the act of removing the cap. Therefore, a second priming parameter related to the physical act of moving a portion of the drug delivery device can be defined as the physical act of moving a portion of the drug delivery device, which is detected by the accelerometer as the act of removing the cap. The act of removing the cap exposes the delivery component, and air or gas and the drug may be discharged through the delivery component as the plunger rod moves proximal. The act of removing the cap is another example of a physical act of moving a portion of the drug delivery device that causes an impact on the drug container, resulting in or at least increasing the possibility of trapped air or gas moving toward the top of the drug container.

[0024] According to one embodiment, the power module is provided with a proximal acceptance interface adapted to accept a disposable cassette, and the method further includes placing the disposable cassette into the power module via the proximal acceptance interface, and the physical act of moving a portion of the drug delivery device is associated with such disposable cassette placement act. Thus, a second priming parameter associated with the physical act of moving a portion of the drug delivery device can be defined as the movement associated with placing the disposable cassette into the power module via the proximal acceptance interface.

[0025] According to one embodiment, the power module comprises an activation interface and a first switch, and the disposable cassette comprises a tubular body and at least one distally extending projection distally away from the distal end of the tubular body, and the method further includes activating the first switch by moving the distally extending projection to contact the activation interface and pushing the activation interface distally during the disposable cassette installation act, and the physical act of moving a portion of the drug delivery device is the movement that causes the activation of the first switch. Thus, a second priming parameter related to the physical act of moving a portion of the drug delivery device can be defined as the movement of the first switch.

[0026] The distally extending projection may have a distally facing surface configured to contact the activation interface of the drug delivery device and push the activation interface distally, thereby triggering the activation of a first switch.

[0027] According to a second aspect of the present disclosure, there is provided a drug delivery device comprising a disposable cassette containing a drug container, the drug delivery device having a proximal end and a distal end, the drug container comprising a drug delivery member having a proximal end, the drug delivery device having a power module having a plunger rod configured to act on the drug container to discharge a drug through the proximal end of the drug delivery member, a drive unit configured to move the plunger rod in a proximal direction, an accelerometer for determining the orientation and acceleration of the drug delivery device, and a control unit, the control unit determining a first priming parameter that is the orientation of the drug delivery device determined by the accelerometer, determining a second priming parameter related to a physical act of moving a part of the drug delivery device, identifying fulfillment of a first priming criterion of the first priming parameter as the position where the drug delivery device is arranged to accommodate the cassette such that the proximal end of the drug delivery member faces upward, identifying fulfillment of a second priming criterion by identifying the presence of the second priming parameter, and in response to identifying fulfillment of the first priming criterion and the second priming criterion, configuring the drive unit to automatically move the plunger rod in a proximal direction to act on the drug container, causing air or gas to be released through the proximal end of the drug delivery member, thereby performing automatic priming of the drug container.

[0028] The effects and features of the second aspect are mostly similar to those described above in relation to the first aspect. The embodiments referred to in relation to the first aspect are mostly compatible with the second aspect, and vice versa, and some of them are exemplified below.

[0029] According to one embodiment, the accelerometer is configured to identify a physical act of moving a part of the drug delivery device, and the control unit is configured to define a second priming parameter based on such identification. Thus, the control unit may be configured to define a second priming parameter as a physical act of moving a part of the drug delivery device detected by the accelerometer.

[0030] According to one embodiment, the disposable cassette includes a cap that protects the drug delivery member, and the accelerometer is configured to identify the act of removing the cap as a physical act of moving a part of the drug delivery device. Thus, the control unit may be configured to define a second priming parameter as a physical act of moving a part of the drug delivery device detected by the accelerometer as the act of removing the cap.

[0031] According to one embodiment, the power module includes a proximal receiving interface adapted to receive the disposable cassette, and the control unit is configured to identify the installation of the disposable cassette to the power module via the proximal receiving interface and to define a second priming parameter based on such act of installing the disposable cassette. Thus, the control unit may be configured to define a second priming parameter as a physical act of moving a part of the drug delivery device related to installing the disposable cassette to the power module via the proximal receiving interface..

[0032] According to one embodiment, the power module comprises an activation interface and a first switch, and the disposable cassette comprises a tubular body and at least one distally extending projection distally extending away from the distal end of the tubular body, the projection being configured to contact the activation interface and move distally to push the activation interface during the act of installing the disposable cassette, thereby activating the first switch, and the control unit is configured to define a second priming parameter as the activation of the first switch. The control unit may be configured to define a second priming parameter as a physical act of moving a part of the drug delivery device as the movement of the first switch.

[0033] According to one embodiment, the power module includes a drive unit. Additionally, or alternatively, the power module includes an accelerometer. Additionally, or alternatively, the power module includes a control unit.

[0034] According to one embodiment applicable to either the first or second aspect of the present disclosure, the tubular body of the disposable cassette comprises a radially extending projection on a radially outward-facing surface, the radially extending projection including a proximal-facing surface.

[0035] According to one embodiment applicable to either one of the first or second aspects of the present disclosure, a disposable cassette can be attached to the proximal end of a power module by insertion of the disposable cassette into the aforementioned proximal acceptance interface and subsequent axial rotation of the disposable cassette, thereby configuring the radially extending projection to slide along the curved distal surface of the power module's acceptance interface until the proximal-facing surface engages with the distal-facing surface of the acceptance interface, thereby locking the disposable cassette longitudinally in its mounting position within the acceptance interface.

[0036] According to one embodiment applicable to either one of the first or second aspects of this disclosure, a disposable cassette comprises an electronic tag attached to the distal end of a tubular body, the electronic tag having stored data relating to a drug stored within the tubular body, and this data being readable by an electronic reader of a drug delivery device when the disposable cassette is in the mounting position. Advantageously, the electronic tag allows the drug delivery device to provide data and make corresponding settings. The stored data may further relate to the volume of the drug container.

[0037] According to one embodiment applicable to either the first or second aspect of this disclosure, the aforementioned operation of the first switch activates the electronic reader. Conveniently, if the disposable cassette is fully inserted into the receiving interface, or at least sufficiently reached, the activation interface is pressed to activate the electronic reader without any additional action required from the user.

[0038] According to one embodiment applicable to either the first or second aspect of the present disclosure, the distally extending projection includes a distally facing inclined surface inclined with respect to the longitudinal axis of the tubular body, the distally facing inclined surface being positioned to interact with the surface of the activation interface as the disposable cassette rotates further. The distally facing inclined surface facilitates the axial movement of the activation interface caused by this interaction. Thus, in one embodiment, the interaction between the distally facing inclined surface and the surface of the activation interface causes the activation interface to move distally.

[0039] According to one embodiment applicable to either one of the first or second aspects of this disclosure, the activation interface activates a second switch when it is moved distally. For example, a disposable cassette may include a delivery member cover, and when a distal force is applied, for example by pressing the delivery member cover against the drug delivery site, the delivery member cover interacts with the activation interface, moving the activation interface further distally and activating the second switch. Advantageously, the activation of the second switch acts to further proximal movement of the plunger rod to act on the drug container to dispense the drug through the proximal end of the drug delivery member. As described above, the plunger rod is typically moved by a drive unit.

[0040] According to one embodiment applicable to either the first or second aspect of the present disclosure, the disposable cassette comprises a second set of radially extending projections on a radially outward-facing surface, configured to engage with a corresponding radially inward-facing slot of the receiving interface to rotatably lock the disposable cassette within the receiving interface. The second set of radially extending projections may be longitudinal ribs.

[0041] According to one embodiment applicable to either the first or second aspect of the present disclosure, the disposable cassette comprises an activation ring detachably attached to a tubular body, the activation ring comprising at least one distally extending projection. The aforementioned electronic tag may be attached to the activation ring.

[0042] According to one embodiment applicable to either the first or second aspect of the present disclosure, the activation ring may comprise two distally extending projections arranged symmetrically with respect to the longitudinal axis of a tubular body. This symmetrical arrangement provides evenly distributed force on the activation surface when a disposable cassette is inserted into the receiving interface of a power module.

[0043] According to one embodiment applicable to either the first or second aspect of the present disclosure, the disposable cassette comprises a plunger rod adapter fitted into a tubular body and configured to be pushed proximal by a plunger rod of a drug delivery device during an automated priming or drug delivery event.

[0044] According to one embodiment applicable to either the first or second aspect of the present disclosure, the disposable cassette comprises a further projection on the radially outward-facing surface of the tubular body, the further projection being located proximal to the radially extending projection and abutting against the receiving interface to limit the insertion length of the disposable cassette in the receiving interface. In this way, the disposable cassette is not inserted too far into the receiving interface.

[0045] According to one embodiment applicable to either the first or second aspect of this disclosure, the attachment between the disposable cassette and the receiving interface is a bayonet coupling.

[0046] According to one applicable embodiment of either the first or second aspect of the present disclosure, the activation interface comprises a first distally extending arm and a second distally extending arm, the first distally extending arm and the second distally extending arm extending toward a first switch and a second switch, respectively, the first arm reaching the first switch as the activation interface moves distally, causing the activation of the first switch.

[0047] According to one applicable embodiment of either the first or second aspect of the present disclosure, the activation interface includes an inclined surface adapted to receive a distal projection of the cassette as the cassette rotates further within the acceptance interface, thereby causing the activation interface to move distally due to the interaction between the distal surface of the cassette and the inclined surface of the activation interface.

[0048] According to one embodiment applicable to either the first or second aspect of the present disclosure, distal motion of the activation interface can cause a second arm to reach a second switch and activate the second switch.

[0049] According to one embodiment applicable to either the first or second aspect of the present disclosure, the distal ends of the first arm and the second arm are asymmetrical.

[0050] According to one embodiment applicable to either the first or second aspect of the present disclosure, advantageously, the subassembly comprises a spring positioned to apply a spring load to the activation interface so as to move away from the first and second switches.

[0051] According to one embodiment applicable to either the first or second aspect of this disclosure, the drug container is a syringe. Thus, the drug delivery member may be a needle. According to one embodiment, the drug delivery device comprises an injection set including a flexible tube connected at its proximal end to a through-hole in a disposable cassette. At the other end of the tube, a needle is typically attached via a pad to a drug delivery site.

[0052] In general, all terms used in the claims should be interpreted according to their ordinary meanings in the art unless expressly otherwise provided herein. All references to “a / an / the element, apparatus, component, means, etc.” should be interpreted broadly as referring to at least one example of an element, apparatus, component, means, etc., unless specifically stated otherwise. [Brief explanation of the drawing]

[0053] Hereafter, specific embodiments of the concept of the present invention will be described illustratively with reference to the attached drawings. [Figure 1] This is a perspective view of a drug delivery device according to an embodiment of the present disclosure. [Figure 2]This is a perspective view of a drug delivery device with the housing removed, according to an embodiment of the present disclosure. [Figure 3] This is a perspective view of a disposable cassette according to an embodiment of the present disclosure. [Figure 4] This is a perspective view of an acceptance interface according to an embodiment of this disclosure. [Figure 5] This is a perspective view of an acceptance interface according to an embodiment of this disclosure. [Figure 6] This is a perspective view of a startup interface according to an embodiment of this disclosure. [Figure 7] This is an enlarged view of the distal end and activation interface of a disposable cassette according to an embodiment of the present disclosure. [Figure 8] This is an enlarged view of the distal end and activation interface of a disposable cassette according to an embodiment of the present disclosure. [Figure 9] This is a flowchart illustrating the steps of a method according to an embodiment of the present disclosure. [Modes for carrying out the invention]

[0054] The concept of the present invention will now be described more fully with reference to the accompanying drawings, which illustrate exemplary embodiments. However, the concept of the present invention can be embodied in many different forms and should not be construed as being limited to the embodiments described herein. Rather, these embodiments are provided as examples so that this disclosure may be thorough and complete and so as to convey the scope of the concept of the present invention to those skilled in the art. Throughout the specification, similar numbers refer to similar components.

[0055] Figure 1 shows an example of a drug delivery device 1, such as a self-injector, according to an embodiment of the present disclosure. The drug delivery device 1 is configured to dispense a drug from a drug container 13 to the user at the dose delivery site via a drug delivery member 2, which is embodied here as a needle. The drug delivery device 1 extends from a proximal end 1a to a distal end 1b with respect to an axis 112.

[0056] In Figure 1, axis 112 is the central axis, and from there, we can define the circumferential direction 131 relative to the central axis 112 and the radial direction 132 extending radially relative to the central axis 112.

[0057] The drug delivery device 1 includes a power module 3 that can be connected to a disposable cassette 4 having a proximal end 4b and a distal end 4a. The power module 3 has corresponding proximal end 3a and distal end 3b and includes a housing 6.

[0058] The disposable cassette 4 comprises a tubular body 11 containing a drug container 13 and a drug delivery member 2 positioned in the tubular body 11, having a proximal end 2a. In the embodiment shown in Figure 1, where the drug delivery member 2 is a needle, the proximal end 2a is the tip of the needle. The disposable cassette 4 is typically adapted to contain drug containers of different capacities, for example, ranging from about 1 ml to about 10 ml.

[0059] The power module 3 includes an acceptance interface 10 configured to accept a disposable cassette 4 and to lock onto the proximal end 3a of the power module 3.

[0060] The disposable cassette 4 includes a cap 5 positioned to protect the drug delivery member 2. In Figure 1, the cap 5 is shown proximal to the disposable cassette 4, as it appears after the cap 5 has been removed from the drug delivery member 2 during the cap removal process.

[0061] The disposable cassette 4 may include a delivery member cover 7 configured to cover the delivery member 2. The delivery member cover 7 is configured to move axially relative to the tubular body 11. For example, as shown in Figure 1, the delivery member cover 7 may be moved from a protruding position to a retracted position, in which case the delivery member cover 7 is further received within the tubular body 11 to expose the delivery member 2 of the drug container 13.

[0062] Figure 2 is a partially exploded view of the drug delivery device 1 with the housing 6 removed from the power module 3 and the cap 5 removed from the disposable cassette 4. As shown in Figure 2, the housing 6 may be divided into two parts, a first housing portion 6a and a second housing portion 6b, the second housing portion 6b being located distal to the first housing portion 6a.

[0063] The power module 3 includes a plunger rod 83 configured to move proximal to act on the drug container 13 in order to discharge air or gas and drug through the proximal end 2a of the drug delivery member 2. The drug delivery device 1 further includes a drive unit 82 configured to move the plunger rod 83 in the proximal direction, and an accelerometer 84 configured to determine the orientation and acceleration of the drug delivery device 1. In the embodiment shown in Figure 2, the drive unit 82 and the accelerometer 84 are included in the power module 3 and housed within the housing 6.

[0064] The power unit 3 may optionally include an antenna 80 (or a set of antennas) and a power pack 86 having electronic circuits and a battery.

[0065] Figure 3 is a perspective view of a disposable cassette according to an embodiment of the present disclosure. As previously stated, the disposable cassette 4 comprises a tubular body 11 adapted to receive a drug container 13 radially inward. The tubular body 11 extends from a proximal end 11a to a distal end 11b, the proximal end 11a of the tubular body 11 typically coincides with the proximal end 4a of the cassette 4. The tubular body 11 has a through hole 15 at its proximal end 11a, through which a drug delivery member 2 (not shown in Figure 3) extends during a drug delivery event.

[0066] The tubular body 11 includes a projection 19 that extends radially on a surface 21 facing radially outward. The radially extending projection 19 includes a surface 23 facing proximal to the body.

[0067] The radially extending projections 19 extend along the outer circumference of the outer surface 21, such that the projections 19 curve along the outer circumference of the outer surface 21, as illustrated in Figure 3, or as two separate radially extending projections 19. However, the projections 19 extend along only a portion of the outer circumference of the tubular body 11.

[0068] The disposable cassette 4 includes an activation ring 27 that is detachably attached to the distal end 11b of the tubular body 11. The activation ring 27 may form at least a portion of the distal end 4b of the disposable cassette 4.

[0069] The disposable cassette 4 may optionally include an electronic tag 25 attached to the distal end of the cassette 4. The electronic tag 25 may be attached to the tubular body 11 or to the activation ring 27. The electronic tag 25 is typically configured to store data related to the drug stored in the drug container 13, such as the drug volume. The electronic tag 25 and the data contained therein may be readable by the electronic reader of the drug delivery device 1 when the disposable cassette 4 is in its mounting position within the power module 3. The electronic reader may include, for example, the aforementioned antenna 80.

[0070] Furthermore, the disposable cassette 4 includes distally extending projections 28 that extend distally away from the distal end 11b of the tubular body 11, or two separate distally extending projections 28, as illustrated in Figure 3. In the embodiment of Figure 3, each of the distally extending projections 28 is included in the launch ring 27. Each of the distally extending projections 28 includes a distally facing surface 29 and a distally facing inclined surface 36 that are inclined with respect to the longitudinal axis 102 of the tubular body 11. The distally facing inclined surface 36 is connected to the distally facing surface 29 at each angle of inclination.

[0071] Therefore, in some possible embodiments, the starter ring 27 comprises two distally extending projections 28 arranged symmetrically with respect to the longitudinal axis 102 of the tubular body 11.

[0072] An additional projection 33 may optionally be positioned on the radially outward-facing surface 21 of the tubular body 11. In Figure 3, the additional projection 33 is located proximal to the radially extending projection 19. Here, the additional projection 33 is an annular projection extending around the outer circumference of the tubular body 11, preferably the entire outer circumference. The additional projection 33 is configured to abut against the proximal end 3a of the power module 3 or the receiving interface 10, thereby limiting the insertion length of the disposable cassette 4 in the receiving interface 10. In other words, the additional projection 33 may act as a stopper to prevent the cassette 4 from being inserted too deeply into the power module 3 and the receiving interface 10.

[0073] Figures 4 and 5 are different perspective views of the proximal acceptance interface 10 of the drug delivery device 1. The proximal acceptance interface 10 is adapted to accept the disposable cassette 4, as described above.

[0074] The proximal receiving interface 10, which includes a curved distal surface 30, is adapted to receive and guide distally slidably a radially extending projection 19 of the cassette 4 as the cassette 4 rotates axially relative to the receiving interface 10. In other words, the disposable cassette 4 is initially inserted axially into the receiving interface 10. During the subsequent axial rotation of the disposable cassette 4, the radially extending projection 19 slides along the curved distal surface 30 of the receiving interface 10 of the power module 3. The radially extending projection 19 slides along the curved distal surface 30 until the proximal surface 23 engages with the distal surface 32 of the receiving interface 10, longitudinally locking the disposable cassette 4 in its mounting position within the receiving interface 10.

[0075] As shown in Figure 5, the receiving interface 10 includes a radially inward-facing slot 38 (only one is shown in Figure 5). The disposable cassette 4 shown in Figure 3 includes a second set of radially outward-extending projections 34 on a radially outward-facing surface 21, which are configured to engage with the corresponding radially inward-facing slot 38 to rotatably lock the disposable cassette 4 within the receiving interface 10. Preferably, the second set of radially extending projections 34 are longitudinal ribs.

[0076] Figure 6 is a perspective view of a starting interface 40 according to an embodiment of the present disclosure. The starting interface 40 includes a proximal end 40a and a distal end 40b. The proximal end 40a includes a projection 42 extending in the proximal direction. As further discussed herein, the projections 42 are configured to receive projections 29 extending distally to the cassette 4 as the cassette 4 rotates. Each projection 42 includes an inclined surface 45 adapted to receive an inclined surface 36 facing distally to the projections 28 extending distally to the disposable cassette 4 as the disposable cassette 4 rotates axially from its mounting position.

[0077] The startup interface 40 comprises a first distally extending arm 44 and a second distally extending arm 54. Each of the first distally extending arm 44 and the second distally extending arm 54 has notches 46, 56 at the distal end 40b of the cassette, and the notches 46, 56 are arranged diagonally to each other such that the first distally extending arm 44 and the second distally extending arm 54 are asymmetrical.

[0078] The launch interface 10 is further provided with longitudinal ribs 48 on the first distally extending arm 44 and the second distally extending arm 54 (only the ribs 48 on the first distally extending arm 44 are shown in Figure 6), and these ribs are configured to fit into and slide in corresponding slots or grooves 39 (shown in Figure 5) on the radially inward facing surface of the receiving interface 10.

[0079] Figures 7 and 8 are enlarged views of the distal end 4b of a disposable cassette 4 that has been inserted into the receiving interface 10 but has not yet been mounted by rotating the disposable cassette 4 within the receiving surface 10 as described above. In Figure 7, the first distally extending arm 44 of the activation interface 40 extends toward the first switch 90. On the opposite side, as shown in Figure 8, the second distally extending arm 54 extends toward the second switch 92. Furthermore, the spring 95 is positioned to apply a spring load to the activation interface 40 so as to move away from the first switch 90 and the second switch 92.

[0080] When the disposable cassette 4 is inserted into the receiving interface 10 and mounted by rotating it within the receiving surface 10 as described above, the radially extending projection 19 slides on the curved distal surface 30 of the receiving interface 10 during the axial rotation of the disposable cassette 4. This sliding motion on the curved surface 30 causes the distal axial movement of the disposable cassette 4 so that the distal surface 29 of the projection 28 contacts and pushes distally against the proximal surface 47 of the activation interface 40. More specifically, the distal inclined surface 36 interacts with the inclined surface 45 of the projection 42 of the activation interface 40 as the disposable cassette 4 rotates. The axial rotation required to lock the disposable cassette 4 may be approximately 60 degrees relative to the receiving interface 10. The spring 95 is compressed by the axial movement of the starting interface 40, which is caused by a distal movement force when the disposable cassette 4 is mounted on the receiving interface 10.

[0081] Therefore, when the disposable cassette 4 rotates axially, the first distally extending arm 44 of the activation interface 40 activates the first switch 90. Since the notch 46 of the first distally extending arm 44 is positioned asymmetrically with respect to the notch 56 of the second distally extending arm 54 (as shown by comparing Figures 8 and 9), the second distally extending arm 54 of the activation interface 40 does not reach the same position on the activation interface 40 within the receiving interface 10 to activate the second switch 92. Therefore, the second switch 92 is not activated by inserting the disposable cassette 4 into the receiving interface 10.

[0082] The second switch 92 can be activated by moving the delivery member cover 7. Typically, when force is applied distally to the delivery member cover 7, for example by pressing the proximal end 7a of the delivery member cover 7 against the drug delivery site, the distal end 7b of the delivery member cover interacts with the activation interface 40, causing the activation interface 40 to move further distally, thereby allowing the second distally extending arm 54 to reach a position that activates the second switch 92.

[0083] The rotation of the disposable cassette 4 in the opposite direction causes the activation interface 40 to move proximally due to the force applied by the spring 95. This can cause the activation and deactivation of the first switch 90 and the second switch 92, depending on the degree of rotation of the disposable cassette 4, which allows the activation interface 40 to move a variable distance proximally. Further rotation in the opposite direction makes it possible to remove the cassette 4 from the receiving interface 10 so that the cassette 4 can be discarded. Subsequently, a new cassette 4 can be attached to the receiving interface 10 as described herein.

[0084] Activation of the first switch 90 may, for example, activate the electronic reader of the power module 3 and read the electronic tag 25. Activation of the second switch may, for example, act on the drug container 13 to dispense the drug through the proximal end 2a of the drug delivery member 2, by moving the plunger rod 83 proximal. As previously mentioned, the plunger rod 83 is typically moved by the drive unit 82. The disposable cassette 4 may include a plunger rod adapter fitted to a tubular body 11. This plunger rod adapter is preferably cylindrical and adapted to be pushed proximal by the plunger rod 83 during a drug delivery event. This proximal movement of the plunger rod adapter dispenses the drug from the drug container 13.

[0085] Figure 9 is a flowchart illustrating the steps of a method for automatically priming a drug container 13 housed in a disposable cassette 4 of a drug delivery device 1 according to an embodiment of the present disclosure. Priming is the act of discharging bubbles or gas bubbles from the drug container before a drug delivery event.

[0086] For example, in the first step, step S10, a first priming parameter is determined, and the first priming parameter is the orientation of the drug delivery device 1 determined by the accelerometer 84. Therefore, the accelerometer 84 can determine the orientation of the drug delivery device 1, for example, whether the drug delivery device 1 is oriented so that the drug delivery member 2 is facing upward or downward.

[0087] For example, in step S15, which is performed following step S10, the drug delivery device 1 containing the cassette 4 is positioned such that the proximal end 2a of the drug delivery member 2 faces upward. For example, upward can be defined here as the proximal end 2a of the drug delivery member 2 facing upward along the vertical axis, or at least within 60 degrees of such a vertical axis. Thus, the drug delivery device 1 may be positioned such that its central axis 112 coincides with the vertical axis (the vertical axis coincides with the gravity axis) and the proximal end 2a of the drug delivery member 2 faces upward, or the drug delivery device 1 may be positioned such that its central axis 112 makes an angle of up to 60 degrees with respect to the vertical axis (in all directions) and the proximal end 2a of the drug delivery member 2 faces upward within those 60 degrees. It should be noted that step S15 may be performed before step S10, i.e., the first priming parameter may be determined when the drug delivery device 1 is already positioned such that the proximal end 2a of the drug delivery member 2 faces upward.

[0088] In step S30, the first priming criterion for the first priming parameter is satisfied. The first priming criterion is satisfied by substep S30a, which identifies the position of the drug delivery device 1 such that the proximal end 2a of the drug delivery member 2 faces upward. Thus, the satisfaction of the first priming criterion is achieved following steps S10 and S15.

[0089] For example, in step S20, which is performed following steps S10 and S15, a second priming parameter is determined, which relates to a physical action that moves a part of the drug delivery device 1. The determination of the second priming parameter in step S20 may include further defining which part of the drug delivery device 1 is moved, but does not necessarily include identifying the actual existence of such movement.

[0090] In step S48, the second priming criterion for the second priming parameter is satisfied. The second priming criterion is satisfied after step S40, in which the presence of the second priming parameter is identified.

[0091] In step S50, which is performed in response to the satisfaction of the first priming criterion in step S30 and the satisfaction of the second priming criterion in step S48, the drug container 13 is automatically primed by the drive unit 82 automatically moving the plunger rod 83 proximal to act on the drug container 13, causing air or gas to be released through the proximal end 2a of the drug delivery member 2. This achieves efficient automatic priming of the drug container 13. The first priming criterion is satisfied by step S30 when the drug delivery device 1 housing the cassette 4 is identified such that the proximal end 2a of the drug delivery member 2 is positioned upward, and the second priming criterion is satisfied by step S48 when a physical act that moves part of the drug delivery device 1 is identified. Therefore, any air or gas trapped in the drug container 13 is likely to move to a location near the drug delivery member 2, typically at the top of the drug container 13, and thus can be released when the plunger rod 83 moves proximal. Preferably, the automatic priming step S50 is performed in response to step S30 satisfying the first priming criterion before step S48 satisfying the second priming criterion, thereby improving the likelihood that trapped air or gas will move towards the top of the drug container 13 before the plunger rod 83 is automatically moved proximal.

[0092] As described above, the disposable cassette 4 may include a plunger rod adapter fitted to be pushed proximal by the plunger rod 83. Thus, the proximal movement of the plunger rod adapter causes the discharge of air or gas through the proximal end 2a of the drug delivery member 2.

[0093] Step S50 may include a substep S52 in which the drive unit 82 moves the plunger rod 83 to a predefined priming position. Thus, priming of the drug container 13 can be performed in a predefined manner.

[0094] Here, we will provide further examples of the second priming parameter determined in step S20.

[0095] In substep S42 of step S40, a physical act that moves a portion of the drug delivery device 1 is identified by the accelerometer 83, and a second priming parameter is defined by such identification. Thus, a second priming parameter related to a physical act that moves a portion of the drug delivery device can be defined as a physical act that moves a portion of the drug delivery device 1 detected by the accelerometer 83.

[0096] Substep S42 may include a first further substep S42a in which the accelerometer 83 identifies repetitive tapping of or on the drug delivery device 1. Thus, the user can move the drug delivery device 1 itself, for example, by lightly tapping the drug delivery device 1 against a hard surface or by lightly tapping on the drug delivery device 1 with a finger. The first substep S42a may include identifying at least three consecutive taps. The determination of the second priming parameter in step S20 may include defining the second priming parameter as repetitive tapping of or on the drug delivery device 1.

[0097] Substep S42 may typically include a second further substep S42b that identifies the cap removal act instead of the first substep S42a. Thus, the user can remove the cap 5 from the disposable cassette 4 and thereby perform the cap removal act. The determination of the second priming parameter in step S20 may include defining the second priming parameter as the cap removal act.

[0098] Instead of using the accelerometer 83 to identify a physical action that moves a portion of the drug delivery device 1, the physical action that moves a portion of the drug delivery device 1 associated with the second priming parameter may be the physical action of placing a disposable cassette 4 into the receiving interface 10 as described with reference to Figures 8 and 9.

[0099] Therefore, in substep S44 of step 40, the disposable cassette 4 is installed in the power module 3 via the proximal receiving interface 10, and the physical act of moving a portion of the drug delivery device 1 is associated with the act of installing such disposable cassette. Thus, the determination of the second priming parameter in step S20 may include defining the second priming parameter as the act of installing disposable cassette.

[0100] For example, a physical act of moving a portion of the drug delivery device 1 associated with a second priming parameter may be related to a further substep S44a of substep S44, which is a movement that causes the activation of the first switch 90. Thus, the second priming parameter is satisfied by identifying the activation of the first switch 90 (S48).

[0101] Returning to Figure 2, the drug delivery device 1 may include a control unit 85, which is configured to perform at least some of the steps described with reference to Figure 9. For example, the control unit may be configured to determine a first priming parameter, which is the orientation of the drug delivery device 1 determined by the accelerometer 83, as described in step S10. The control unit 85 may be further configured to determine a second priming parameter, which relates to a physical action that moves a portion of the drug delivery device 1, as previously mentioned.

[0102] The control unit 85 may be configured to identify the satisfaction of the first priming criterion for the first priming parameter as the position in which the drug delivery device 1 housing the cassette 4 is positioned such that the proximal end 2a of the drug delivery member 2 faces upward, as described in step S30. The control unit 85 may be further configured to identify the satisfaction of the second priming criterion by identifying the presence of the second priming parameter, as described in step S48.

[0103] The control unit 85 may be configured to perform automatic priming of the drug container 13 by having the drive unit 82 automatically move the plunger rod 83 in the proximal direction in response to identifying that the first and second priming criteria have been met, thereby causing the drug container 13 to act on the drug container 13 and release air or gas through the proximal end 2a of the drug delivery member 2.

[0104] Corresponding to the method described in the flowchart of Figure 9, the control unit 85 may be configured to define and identify a second priming parameter as a physical act of moving a portion of the drug delivery device as detected by the accelerometer 83. Additionally or alternatively, the control unit 85 may be configured to define and identify a second priming parameter as a physical act of moving a portion of the drug delivery device 1 as detected by the accelerometer 83 as a cap removal act. Additionally or alternatively, the control unit 85 may be configured to define and identify a second priming parameter as a physical act of moving a portion of the drug delivery device as a movement associated with placing the disposable cassette 4 into the power module 3 via the proximal acceptance interface 10. The control unit may be configured to define and identify a second priming parameter as a physical act of moving a portion of the drug delivery device 1 as a movement of the first switch 90.

[0105] A drug delivery device (such as an auto-injector) may generally include a variety of other components, such as: a sensor unit that can recognize drug delivery events, such as when a drug delivery component is inserted into a pad attachment area, when an injection begins, and when a drug delivery event is completed; a memory unit configured to store data recorded during a drug delivery event; a connectivity unit configured to transmit the stored data directly to a smart device or network; a processing unit (e.g., the control unit 85 mentioned above) configured to control the entire system and process the data before transmitting it; and / or a user interface unit configured to provide feedback to the patient, such as status LEDs, tactile feedback, and / or audio feedback.

[0106] When the drug delivery device is placed on the attachment site, sensors inside the pad recognize this event and are configured to provide feedback to the patient via tactile / visual or auditory elements.

[0107] When a drug delivery event is complete, the sensor is configured to recognize the event and provide feedback to the patient again. Furthermore, the collected data can be stored in a memory unit and transmitted to a smart device / network via a connectivity unit after the drug delivery event has finished.

[0108] The sensor can be a mechanical switch, a Hall effect sensor, an accelerometer, or a combination thereof.

[0109] A mechanical switch, a Hall effect sensor, or an accelerometer can be used to detect the insertion of a drug delivery component into the injection port.

[0110] Accelerometers can be used to detect drug delivery events.

[0111] Possible wireless communication methods include Bluetooth and cellular networks.

[0112] Bluetooth connectivity requires a smart device to transmit stored data over the network, and in the case of bidirectional connectivity, a pairing process is required between the pad and the smart device before the support pad can be used. However, this is a cheaper alternative and requires less space on the PCB. Unidirectional connectivity does not require pairing.

[0113] Cellular networks do not require a pairing process and can be used as plug-and-play devices, requiring no prior setup, but they are expensive and require a lot of space on the PCB.

[0114] Depending on the product requirements, one of these two technologies can be used.

[0115] The processing unit, for example, the control unit 85 described above, may comprise a further control unit including processing circuits, logic circuits, and / or a microprocessor, microcontroller, programmable digital signal processor, or other programmable device. The processing circuit may also, or instead, include, an application-specific integrated circuit, a programmable gate array or programmable array logic, a programmable logic device, or a digital signal processor, each. If the processing circuit includes a programmable device such as the microprocessor, microcontroller, or programmable digital signal processor described above, the processor may further include computer executable code that controls the operation of the programmable device.

[0116] The drug delivery devices described herein can be used to treat and / or prevent one or more of many different types of disorders. Exemplary disorders include, but are not limited to, rheumatoid arthritis, inflammatory bowel disease (e.g., Crohn's disease and ulcerative colitis), hypercholesterolemia, diabetes (e.g., type 2 diabetes), psoriasis, migraine, multiple sclerosis, anemia, lupus, atopic dermatitis, asthma, nasal polyps, acute hypoglycemia, obesity, anaphylaxis, and allergies. Exemplary drug types that may be included in the drug delivery devices described herein include, but are not limited to, small molecule compounds, hormones, cytokines, blood products, antibodies, antibody-drug conjugates, bispecific antibodies, proteins, fusion proteins, peptide bodies, polypeptides, PEGylated proteins, protein fragments, protein analogs, protein variants, protein precursors, chimeric antigen receptor T-cell therapy, cell or gene therapy, oncolytic viruses, or immunotherapy.Examples of drugs that may be included in an injection assembly include etanercept (rheumatoid arthritis, inflammatory bowel disease (e.g., Crohn's disease and ulcerative colitis)), evolocumab (hypercholesterolemia), exenatide (type 2 diabetes), secukinumab (psoriasis), erenumab (migraine), alirocumab (rheumatoid arthritis), methotrexate (ametopterin) (rheumatoid arthritis), tocilizumab (rheumatoid arthritis), interferon β-1a (multiple sclerosis), and smatotrione. Butan (migraine), adalimumab (rheumatoid arthritis), darbepoetin alfa (anemia), belimumab (lupus), pegylated interferon β-1a' (multiple sclerosis), sarilumab (rheumatoid arthritis), semaglutide (type 2 diabetes, obesity), dupilumab (atopic dermatitis, asthma, nasal polyps, allergies), glucagon (acute hypoglycemia), epinephrine (anaphylaxis), insulin (diabetes), atropine and vedolizumab (inflammatory bowel disease (for example) (For Crohn's disease and ulcerative colitis), ipilimumab, nivolumab, pembrolizumab, atezolizumab, durvalumab, avelumab, semiprimab, rituximab, trastuzumab, ad-trastuzumab emtansine, fam-trastuzumab deruxtecan-NXKI, pertuzumab, transtuzumab-pertuzumab, alemtuzumab, verantamab mahodotin-BLMF, bevacizumab, blinatumomab, brentuximab vedotin, se Examples of drugs that may cause adverse effects include, but are not limited to, tuximab, daratumumab, elotuzumab, gemtuzumab ozogamicin, 90-yttrium-ibritumomab tiuxetan, isatuximab, mogamulizumab, moxetumomab pasudotox, obinutuzumab, ofatumumab, olaratumumab, panitumumab, polatuzumab vedotin, ramucirumab, sacituzumab govitecan, tafacitamab, or margetuximab (examples in parentheses are non-limiting examples of associated disorders). Pharmaceutical formulations containing, but not limited to, any of the drugs described herein, for example, pharmaceutical formulations containing the drugs listed herein (or pharmaceutically acceptable salts thereof) and pharmaceutically acceptable carriers, are also intended for use in the drug delivery devices described herein.A pharmaceutical formulation containing any of the drugs listed herein (or pharmaceutically acceptable salts thereof) may contain one or more other active ingredients, or it may contain only one active ingredient. The pharmaceutical formulation may also contain a dispersant, such as hyaluronidase, which is administered separately or formulated together with the drug.

[0117] Examples of drugs that may be included in the drug delivery devices described herein include, but are not limited to, immuno-oncological or bio-oncological agents such as immune checkpoints, cytokines, chemokines, differentiation clusters, interleukins, integrins, growth factors, enzymes, signaling proteins, pro-apoptotic proteins, anti-apoptotic proteins, T cell receptors, B cell receptors, or costimulatory proteins.

[0118] Exemplary drugs that may be included in the drug delivery devices described herein include HER-2 receptor modulators, interleukin modulators, interferon modulators, CD38 modulators, CD22 modulators, CCR4 modulators, VEGF modulators, EGFR modulators, CD79b modulators, Trop-2 modulators, CD52 modulators, BCMA modulators, PDGFRA modulators, SLAMF7 modulators, PD-1 / PD-L1 inhibitors / modulators, B lymphocyte antigen CD19 inhibitors, B lymphocyte antigen CD20 modulators, CD3 modulators, CTLA-4 inhibitors, and TIM-3 modulators. Examples of proposed mechanisms of action include, but are not limited to, VISTA modulators, INDO inhibitors, LAG3 (CD223) antagonists, CD276 antigen modulators, CD47 antagonists, CD30 modulators, CD73 modulators, CD66 modulators, CDw137 agonists, CD158 modulators, CD27 modulators, CD58 modulators, CD80 modulators, CD33 modulators, APRIL receptor modulators, HLA antigen modulators, EGFR modulators, B lymphocyte adhesion molecule modulators, CDw123 modulators, Erbb2 tyrosine kinase receptor modulators, mesothelin modulators, HAVCR2 antagonists, NY-ESO-1 OX40 receptor agonist modulators, adenosine A2 receptors, ICOS modulators, CD40 modulators, TIL therapy, or TCR therapy.

[0119] Exemplary drugs that may be included in the drug delivery devices described herein include AC, high-dose AC, TCH, GT, EC, TAC, TC, TCHP, CMF, FOLFOX, mFOLFOX6, mFOLFOX7, FOLFCIS, CapeOx, FLOT, DCF, FOLFIRI, FOLFIRINOX, FOLFOXIRI, IROX, CHOP, R-CHOP, RCHOP-21, Mini-CHOP, Maxi-CHOP, VR-CAP, high-dose 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, and CALGB88. Examples of multi-drug therapy regimens include, but are not limited to, 11, 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.

[0120] Examples of drugs that may be included in the drug delivery devices described herein include, but are not limited to, alkylating agents, plant alkaloids, antitumor antibiotics, antimetabolites, or topoisomerase inhibitors, enzymes, retinoids, or corticosteroids used in chemotherapy. Examples of exemplary chemotherapy drugs include, but are not limited to, 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, barrubicin, vincristine, vinblastine, or vinorelbine.

[0121] The concept of the present invention has been explained primarily by reference to several examples. However, as will be readily apparent to those skilled in the art, other embodiments not disclosed above are equally possible within the scope of the concept of the present invention as defined by the appended claims.

Claims

1. A method for automatically priming a drug container (13) housed in a disposable cassette (4) of a drug delivery device (1) having a proximal end (1a) and a distal end (1b), wherein the drug container (13) comprises a drug delivery member (2) having a proximal end (2a), the drug delivery device (1) comprises a power module (3) having a plunger rod (83) configured to act on the drug container (13) to dispense a drug through the proximal end (2a) of the drug delivery member (2), a drive unit (82) configured to move the plunger rod (83) in the proximal direction, and an accelerometer (84) for determining the orientation and acceleration of the drug delivery device (1), the method is as follows: - Determining the first priming parameter which is the orientation of the drug delivery device (1) determined by the accelerometer (84) (S10), - Determining a second priming parameter related to a physical act of moving a part of the drug delivery device (1) (S20), A method comprising: - S30a identifying the position of the drug delivery device (1) housing the cassette (4) such that the proximal end (2a) of the drug delivery member (2) faces upward, thereby satisfying a first priming criterion for the first priming parameter (S30); and S48 identifying the presence of the second priming parameter (S40), thereby satisfying a second priming criterion, by causing the drive unit (82) to automatically move the plunger rod (83) in the proximal direction to act on the drug container (13) and release air or gas through the proximal end (2a) of the drug delivery member (2), thereby performing automatic priming of the drug container (13) (S50).

2. The method according to claim 1, wherein the automatic priming (S50) is performed in response to satisfying the first priming criterion (S30) before satisfying the second priming criterion (S48).

3. The method according to claim 1 or 2, wherein the automatic priming (S50) is performed by moving the plunger rod (83) to a predefined priming position (S52) by the drive unit (82).

4. The method according to any one of claims 1 to 3, further comprising using the accelerometer (83) to identify the physical act of moving a portion of the drug delivery device (1) (S42), wherein the second priming parameter is defined by such identification.

5. The method according to claim 4, wherein the physical act of moving a portion of the drug delivery device (1) identified by the accelerometer (83) (S42) is repeated tapping (S42a) of or on the drug delivery device (1).

6. The method according to claim 5, wherein the drug delivery device (1) or the repetitive tapping on the drug delivery device (1) includes at least three consecutive taps.

7. The method according to claim 4, wherein the disposable cassette (4) comprises a cap (5) that protects the drug delivery member (2), and the physical act of moving a part of the drug delivery device (1) identified by the accelerometer (83) (S42) is the act of removing the cap (S42b).

8. The method according to any one of claims 1 to 4, wherein the power module (3) comprises a proximal acceptance interface (10) adapted to accept the disposable cassette (4), the method further comprises (S44) placing the disposable cassette (4) into the power module (3) via the proximal acceptance interface (10), and the physical act of moving a portion of the drug delivery device (1) is related to such disposable cassette placement act (S44).

9. The power module (3) comprises an activation interface (40) and a first switch (90), and the disposable cassette (4) comprises a tubular body (11) and at least one distally extending projection (28) that extends distally away from the distal end (4b) of the tubular body (11), and the method further comprises, during the disposable cassette installation act (S44), moving the distally extending projection (28) against the activation interface (40) and pushing the activation interface (40) distally (S44a) to activate the first switch (90), and the physical act of moving a part of the drug delivery device (1) is the movement (S44a) that causes the activation of the first switch (90), the method according to claim 8.

10. A drug delivery device (1) comprising a disposable cassette (4) containing a drug container (13), wherein the drug delivery device (1) has a proximal end (1a) and a distal end (1b), and the drug container (13) comprises a drug delivery member (2) having a proximal end (2a), and the drug delivery device (1) comprises, - A power module (3) having a plunger rod (83) configured to act on the drug container (13) in order to dispense the drug through the proximal end (2a) of the drug delivery member (2), - A drive unit (82) configured to move the plunger rod (83) in the proximal direction, - An accelerometer (84) for determining the orientation and acceleration of the drug delivery device (1), - comprising a control unit (85), the control unit (85) is - Determine the first priming parameter which is the orientation of the drug delivery device (1) as determined by the accelerometer (83), - Determine a second priming parameter related to a physical act of moving a part of the drug delivery device (1), - The position in which the drug delivery device (1) containing the cassette (4) is positioned such that the proximal end (2a) of the drug delivery member (2) faces upward, by identifying the satisfaction of the first priming criterion of the first priming parameter and identifying the presence of the second priming parameter, the satisfaction of the second priming criterion is identified. A drug delivery device (1) is configured such that, in response to identifying the satisfaction of the first and second priming criteria, the drive unit (82) automatically moves the plunger rod (83) in the proximal direction to act on the drug container (13) and perform automatic priming of the drug container (13) by causing air or gas to be released through the proximal end (2a) of the drug delivery member (2).

11. The drug delivery device (1) according to claim 10, wherein the accelerometer (83) is configured to identify the physical act of moving a portion of the drug delivery device (1), and the control unit (85) is configured to define the second priming parameter by such identification.

12. The drug delivery device (1) according to claim 11, wherein the disposable cassette (4) comprises a cap (5) that protects the drug delivery member (2), and the accelerometer is configured to identify the act of removing the cap as the physical act of moving a part of the drug delivery device (1).

13. The drug delivery device (1) according to claim 10 or 11, wherein the power module (3) comprises a proximal acceptance interface (10) adapted to accept the disposable cassette (4), and the control unit (85) is configured to identify the placement of the disposable cassette (4) to the power module (3) via the proximal acceptance interface (10) and to define the second priming parameter based on such disposable cassette placement act.

14. The drug delivery device (1) according to claim 13, wherein the power module (3) comprises an activation interface (40) and a first switch (90), the disposable cassette (4) comprises a tubular body (11) and at least one distally extending projection (28) that extends distally away from the distal end (4b) of the tubular body (11), the at least one distally extending projection (28) is configured to contact the activation interface (40) and move to push the activation interface (40) distally during the disposable cassette installation, thereby activating the first switch (90), and the control unit (85) is configured to define the second priming parameter as the activation of the first switch (90).

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