Disposable cassette, drug delivery device subassembly, and drug delivery device

Abstract

The present disclosure relates generally to medication delivery devices, such as autoinjectors, and more particularly to disposable cassettes configured to house medication containers and subassemblies for medication delivery devices.

Description

[Technical Field]

[0001] The present disclosure relates generally to medication delivery devices such as autoinjectors or infusers, and more particularly to disposable cassettes configured to house medication containers and subassemblies for medication delivery devices. [Background technology]

[0002] Many medical conditions require injections. In recent years, a variety of injection devices have emerged, including various types of pen-type injectors, auto-injectors, and infusion devices for large-volume injections. While many of these devices have enabled significant improvements in the management of many medical conditions, limitations remain with current technology. The challenges faced by patients who require frequent injections, and especially those who need to inject highly viscous medications, are particularly significant. Furthermore, reducing the number of injections is often desirable for increased patient convenience. In considering these issues, the applicant recognizes that various developments are possible to help improve currently available drug delivery devices, for example, more effective means for administering larger injection volumes, and these developments are described in detail below. Summary of the Invention

[0003] It is an object of the present disclosure to provide a cassette and subassembly for a medication delivery device that overcomes or at least alleviates problems in the prior art.

[0004] According to a first aspect of the present disclosure, there is provided a disposable cassette configured to house a medication container, the cassette being attachable to a medication delivery device for delivering a medication to a medication delivery site via an infusion set attachable to the cassette, the cassette comprising: The device includes a tubular body adapted to receive a medication container radially inside the tubular body, the tubular body having a through hole at a proximal end through which an adapter of an infusion set can be attached to the medication container.

[0005] The tubular body includes radially extending projections on a radially outwardly facing surface, the radially extending projections including a proximally facing surface.

[0006] The disposable cassette can be attached to the proximal end of the medication delivery device by inserting the disposable cassette into the proximal receiving interface of the medication delivery device and then rotating the disposable cassette axially so that the radially extending protrusions are configured to slide over the curved distal-facing surface of the receiving interface of the medication delivery device until the proximal-facing surface engages with the distal-facing surface of the receiving interface to longitudinally lock the disposable cassette in an attached position within the receiving interface.

[0007] Embodiments of the present disclosure advantageously provide a disposable cassette containing a medication container. The disposable cassette is attachable to a medication delivery device by inserting it into a receiving interface and locking the disposable cassette into the receiving interface. Individual disposable cassettes allow for varying amounts of medication to be delivered using the same medication delivery device. Thus, the volume of the medication container can range from a small volume of approximately 2 mL to a large volume of approximately 10 mL or more, depending on the size of the disposable cassette. Regardless of the amount of medication, engagement with the medication delivery device is the same as provided by the interface between the receiving interface of the medication delivery device and the disposable cassette.

[0008] Embodiments of the present disclosure further provide the advantage of being able to administer larger amounts of drug, thereby reducing the number of injections required, thereby eliminating problems associated with drug injections of highly viscous drug solutions if the same amount of drug can be provided in smaller amounts, reducing the number of injections required.

[0009] Furthermore, the use of disposable cassettes provides an environmentally friendly and cost-effective solution for demonstrating multiple drugs on a single device.

[0010] In this disclosure, when the term "distal direction" is used, it refers to the direction away from the dose delivery site during use of the drug delivery device. When the term "distal part / end" is used, it refers to the part / end of the delivery device, or a part / end of a component thereof, that is located furthest away from the dose delivery site during use of the drug delivery device. Correspondingly, when the term "proximal direction" is used, it refers to the direction towards the dose delivery site during use of the drug delivery device. When the term "proximal part / end" is used, it refers to the part / end of the delivery device, or a part / end of a component thereof, that is located nearest to the dose delivery site during use of the drug delivery device.

[0011] Additionally, the terms "longitudinal," "longitudinally," "axially," or "axial" refer to a direction extending along a device or component thereof from the proximal end to the distal end, generally in the direction of the greatest extension of the device and / or component.

[0012] Similarly, the terms "transverse," "transversal," and "transversally" refer to a direction generally perpendicular to the longitudinal direction.

[0013] Additionally, the terms "circumference," "circumferential," and "circumferentially" refer to the periphery or direction 301 relative to an axis 102, typically a central axis extending in the longest direction of the device and / or component. Similarly, "radial" or "radially" refers to a direction 302 extending radially relative to an axis, and "rotation," "rotational," and "rotationally" refer to rotation relative to an axis.

[0014] According to one embodiment, the disposable cassette may include an electronic tag attached to the distal end of the tubular body, the electronic tag having stored data relating to the medication stored within the tubular body, the data being readable by an electronic reader of the medication delivery device when the disposable cassette is in its attached position. Advantageously, the electronic tag provides the data to the medication delivery device, enabling it to make corresponding settings.

[0015] According to one embodiment, the disposable cassette may include at least one distally extending protrusion extending distally away from the distal end of the tubular body, the at least one distally extending protrusion including a distally facing surface configured to abut and push distally against an activation interface of the medication delivery device to cause activation of a first switch that activates the electronic reader. Thus, when the disposable cassette is fully inserted into the receiving interface, or at least sufficiently reaches the activation interface, this activation interface may be conveniently pushed to activate the electronic reader without any additional action required from the user.

[0016] According to one embodiment, the distally extending protrusion includes a distally facing angled surface that is inclined relative to the longitudinal axis of the tubular body, the distally facing angled surface being positioned to interact with a surface of the actuation interface upon further rotation of the disposable cassette, the interaction with the distally facing angled surface assisting in the axial movement of the actuation interface caused by this interaction.

[0017] Thus, in one embodiment, interaction of the distally facing ramp with the surface of the actuation interface causes the actuation interface to move distally.

[0018] Furthermore, in one embodiment, the activation interface activates a second switch when moved distally upon interaction. Thus, simply rotating the disposable cassette causes the activation interface to activate the second switch. Advantageously, activation of the second switch activates the plunger rod of the medication delivery device to initiate a priming action of the medication container. Priming is the action of expelling air bubbles from the syringe.

[0019] According to one embodiment, the disposable cassette may include a second set of radially extending protrusions on its radially outwardly facing surface configured to engage corresponding radially inwardly facing slots in the receiving interface to rotationally lock the disposable cassette within the receiving interface. The rotational locking provides an intermediate position for the disposable cassette in which the electronic reader is activated but the plunger rod has not yet moved axially.

[0020] According to one embodiment, the second set of radially extending protrusions may be longitudinal ribs.

[0021] According to one embodiment, the disposable cassette may include an activation ring removably mounted radially inward of the tubular body, the activation ring including at least one distally extending protrusion. An electronic tag may be attached to the activation ring.

[0022] According to one embodiment, the actuation ring may include two distally extending projections symmetrically arranged relative to the longitudinal axis of the tubular body, the symmetrical arrangement providing an evenly distributed force transfer on the actuation surface when the disposable cassette is inserted into the receiving interface of the medication delivery device.

[0023] According to one embodiment, the disposable cassette may advantageously include a removable tamper seal sealing the through-hole in the proximal end of the tubular body, the tamper seal being removed by the user prior to use of the disposable cassette.

[0024] Additionally, the disposable cassette may advantageously include a plunger rod adapter fitted within the tubular body to be pushed proximally by a plunger rod of a medication delivery device during a medication delivery event.

[0025] According to one embodiment, the disposable cassette may include an annular cavity at the proximal end of the tubular body between the tubular body and the medication container, the annular cavity configured to receive a flange of an adapter of an infusion set, thereby providing improved locking capabilities in the annular cavity for locking the infusion set to the disposable cassette.

[0026] According to one embodiment, the tubular body may include a longitudinal rib facing radially inward within the cavity, the longitudinal rib adapted to rotationally lock the adapter, the longitudinal rib providing a reliable method of providing rotational locking when engaging a mating groove or trench.

[0027] According to one embodiment, the disposable cassette may include a further protrusion on the radially outwardly facing surface of the tubular body, the further protrusion being located proximally relative to the radially extending protrusion, the further protrusion being configured to abut the receiving interface and limit the insertion length of the disposable cassette in the receiving interface, in this way preventing the disposable cassette from being over-inserted into the receiving interface.

[0028] According to one embodiment, the attachment between the disposable cassette and the receiving interface may be a bayonet coupling.

[0029] Additionally, an infusion device is provided that includes a medication delivery device and a disposable cassette.

[0030] According to a second aspect of the present disclosure, there is provided a subassembly for a medication delivery device, the subassembly including: a proximal receiving interface adapted to receive a cassette containing a medication container, the proximal receiving interface including a curved distal-facing surface adapted to receive and slidably guide a radially extending protrusion of the cassette in a distal direction when the cassette is rotated axially relative to the receiving interface until a proximal-facing surface of the cassette engages a distal-facing surface of the receiving interface to longitudinally lock the disposable cassette in an attached position within the receiving interface; and an activation interface including a proximal-facing surface adapted to receive a distally extending protrusion of the cassette, wherein when the activation interface is pushed distally by the cassette, it causes activation of a first switch of the subassembly to activate an electronic reader that reads an electronic tag of the cassette.

[0031] According to one embodiment, the activation interface may include first and second distally extending arms extending toward respective first and second switches, the first arm reaching the first switch and causing activation of that switch when the activation interface moves distally.

[0032] According to one embodiment, the actuation interface may include a ramp adapted to receive a distally extending protrusion of the cassette as the cassette is further rotated within the receiving interface, thereby causing the actuation interface to move distally due to interaction between the distally facing surface of the cassette and the ramp of the actuation interface.

[0033] According to one embodiment, distal movement of the annular actuation interface can cause the second arm to reach and activate the second switch.

[0034] According to one embodiment, the distal ends of the first and second arms may be asymmetrical.

[0035] According to one embodiment, the subassembly may advantageously include a spring arranged to spring-load the activation interface away from the first switch and the second switch.

[0036] Further provided is a medication delivery device including a subassembly of any of the embodiments disclosed herein.

[0037] In general, all terms used in the claims should be interpreted according to their ordinary meaning in the art unless expressly defined otherwise herein. All references to "a / an / the" element, device, component, means, etc. should be interpreted without limit as referring to at least one instance of that element, device, component, means, etc., unless expressly specified otherwise. [Brief explanation of the drawings]

[0038] Specific embodiments of the inventive concepts will now be described, by way of example only, with reference to the accompanying drawings in which: [Figure 1] FIG. 1 is a perspective view of a medication delivery device according to an embodiment of the present disclosure. [Figure 2A] FIG. 1 is a perspective view of a disposable cassette according to an embodiment of the present disclosure. [Figure 2B] FIG. 10 is a perspective view of a proximal end of a tubular body and an adapter of an infusion set according to an embodiment of the present disclosure. [Figure 3] FIG. 1 is a perspective view of a receiving interface according to an embodiment of the present disclosure. [Figure 4] FIG. 1 is a perspective view of a receiving interface according to an embodiment of the present disclosure. [Figure 5] FIG. 1 is a perspective view of a receiving interface according to an embodiment of the present disclosure. [Figure 6] FIG. 1 is a perspective view of an activation interface according to an embodiment of the present disclosure. [Figure 7] FIG. 1 is a perspective view of an activation interface according to an embodiment of the present disclosure. [Figure 8] FIG. 1 is a perspective view of a medication delivery device with the housing removed according to an embodiment of the present disclosure. [Figure 9] FIG. 10 is a close-up view of a distal end of a disposable cassette and a receiving interface according to an embodiment of the present disclosure. [Figure 10] FIG. 10 is a close-up view of a distal end of a disposable cassette and an activation interface according to an embodiment of the present disclosure. [Figure 11] FIG. 10 is a close-up view of a distal end of a disposable cassette and an activation interface according to an embodiment of the present disclosure. [Figure 12] FIG. 10 is a close-up view of a distal end of a disposable cassette and an activation interface according to an embodiment of the present disclosure. [Figure 13] FIG. 10 is a close-up view of a distal end of a disposable cassette and an activation interface with a first switch activated, according to an embodiment of the present disclosure. [Figure 14]FIG. 10 is a close-up view of a distal end of a disposable cassette and an activation interface with a first switch activated, according to an embodiment of the present disclosure. [Figure 15] FIG. 10 is a close-up view of the distal end of the disposable cassette and the activation interface with the second switch activated, according to an embodiment of the present disclosure. DETAILED DESCRIPTION OF THE INVENTION

[0039] The inventive concepts will now be described in more detail with reference to the accompanying drawings, in which exemplary embodiments are shown. However, the inventive concepts may be embodied in many different forms and should not be construed as limited to the embodiments set forth herein. Rather, these embodiments are provided as examples so that this disclosure will be thorough and complete, and will fully convey the scope of the inventive concepts to those skilled in the art. Like numbers refer to like elements throughout the description.

[0040] 1 illustrates an example of a medication delivery device 1, such as an autoinjector injection device or infusion device 100, according to an embodiment of the present disclosure. The medication delivery device 1 is configured to expel a medication from a medication container through a medication delivery member, such as a needle 2, to a user at a dose delivery site. The medication delivery device 1 extends from a proximal end 1 a to a distal end 1 b relative to an axis 102.

[0041] The medication delivery device 1 comprises a housing 3 and is connectable to a disposable cassette 4 having a proximal end 4b and a distal end 4a.

[0042] The disposable cassette 4 is connected to an infusion set 6, which includes a flexible tube 7 connected to a through-hole and the proximal end 4a of the disposable cassette 4. The other end of the tube 7 is attached to a needle 2 via a pad P.

[0043] The disposable cassette 4 is adapted to accommodate medication containers, which may be of various volumes, for example, ranging from about 1 mL to about 10 mL.

[0044] The medication delivery device 1 includes a receiving interface 10 configured to receive and lock a disposable cassette to the proximal end 1 a of the medication delivery device 1 .

[0045] 2A is a perspective view of a disposable cassette 4 according to an embodiment of the present disclosure. The disposable cassette 4 includes a tubular body 11 adapted to receive a medication container 13 radially inwardly of the tubular body 11. The tubular body 11 has a through-hole 15 at its proximal end 4a through which an adapter 17 of an infusion set 6 can be attached to the medication container 13. Preferably, a removable tamper seal sealing the through-hole 15 must be removed before the adapter 17 can be attached to the through-hole 15.

[0046] 2B , in some embodiments, the tubular body 11 includes longitudinal ribs 18 at the proximal end 4a of the tubular body 4 that face radially inward within a cavity between the medication container 13 and the tubular body. The annular cavity is configured to receive a flange 22 of an adapter 17 of an infusion set. The longitudinal ribs 18 are adapted to engage longitudinal slots 24 in the flange 22 to rotationally lock the adapter. Additionally, radially inwardly extending projections 20 on the flange 22 engage or grip a neck 26 or crimped portion of the medication container 13. The tubular body 4 is adapted to allow the adapter 17 to expand when the adapter is installed over the neck 26 of the medication container.

[0047] 2A, tubular body 11 includes radially extending projections 19 on radially outwardly facing surface 21. Radially extending projections 19 include proximally facing surfaces 23.

[0048] The radially extending projections 19, or as illustrated here as two separate projections 19, extend along the circumference of the outer surface 21 such that the projections 19 curve along the circumference of the outer surface 21. However, the projections 19 extend only along a portion of the circumference of the tubular body 11.

[0049] The disposable cassette 4 includes an electronic tag 25, here attached to the distal end 4b of the tubular body 11. The electronic tag 25 may be attached to the tubular body 11 or to an activation ring 27 removably attached radially inside the tubular body 11. The electronic tag 25 is configured to store data relating to the medication stored within the tubular body. This data is readable by an electronic reader of the medication delivery device 1 when the disposable cassette is in its attached position in the medication delivery device 1.

[0050] Additionally, the disposable cassette 4 includes at least one distally extending protrusion 28 that extends distally away from the distal end 4b of the tubular body 11. The at least one distally extending protrusion 28 includes a distally-facing surface 29. Each distally extending protrusion 28 includes a distally-facing angled surface 36 that is inclined relative to the longitudinal axis 102 of the tubular body. The distally-facing angled surface 36 connects with the distally-facing surface 29 at an oblique angle.

[0051] In some possible embodiments, the actuation ring 27 includes two distally extending projections 28 symmetrically disposed about the longitudinal axis 102 of the tubular body 11 .

[0052] A further protrusion 33 is disposed on the radially outwardly facing surface of the tubular body 11. The further protrusion 33 is located proximal to the radially extending protrusion 19. Here, the protrusion is an annular protrusion 33 that extends around the outer periphery, preferably the entire periphery, of the tubular body 11. The further protrusion 33 is configured to abut against the proximal end of the receiving interface 10 and limit the insertion length of the disposable cassette 4 in the receiving interface 10. In other words, the annular protrusion 33 functions like a stop that prevents the cassette 4 from being inserted too deeply into the receiving interface 10.

[0053] In this embodiment, a plunger rod adapter 35 is fitted to the tubular body 11. The plunger rod adapter is cylindrical and adapted to be pushed proximally by a plunger rod of a drug delivery device during a drug delivery event. This proximal movement of the plunger rod adapter 35 expels the drug from the drug container 13.

[0054] 3 to 5 are different perspective views of the proximal receiving interface 10 of the medication delivery device 1. The proximal receiving interface 10 is adapted to receive the cassette 4.

[0055] The proximal receiving interface 10, which includes a curved, distally-facing surface 30, is adapted to receive and slidably guide the radially-extending protrusions 19 of the cassette 4 in a distal direction when the cassette is rotated axially relative to the receiving interface 10. In other words, the disposable cassette 4 is first inserted axially into the receiving interface 10. During subsequent axial rotation of the disposable cassette 4, the radially-extending protrusions 19 slide over the curved, distally-facing surface 30 of the receiving interface 10 of the medication delivery device 1. The protrusions 19 slide over the curved surface 30 until the proximal-facing surface 23 engages the distal-facing surface 32 of the receiving interface 10, longitudinally locking the disposable cassette 4 in an attached position within the receiving interface 10.

[0056] 2A includes a second set of radially outwardly extending protrusions 34 on the radially outwardly facing surface 21 that are configured to engage corresponding radially inwardly facing slots 38 in the receiving interface 10 to rotationally lock the disposable cassette 8 within the receiving interface 10. Preferably, the second set of radially extending protrusions 34 are longitudinal ribs.

[0057] 6 and 7 are two perspective views of an activation interface 40 according to an embodiment of the present disclosure. The activation interface 40 includes a proximal end 40a and a distal end 40b. The proximal end 40a includes a proximally extending protrusion 42. As discussed further herein, the protrusion 42 is configured to receive the distally extending protrusion 29 of the cassette 4 as the cassette 4 rotates. The protrusion 42 includes an angled surface 45 adapted to receive the distally extending protrusion 36 of the disposable cassette 4 as the disposable cassette 4 is axially rotated from its mounted position.

[0058] The actuation interface 40 includes first 44 and second distally extending arms 54. The first 44 and second distally extending arms 54 each include cutouts 46, 56 on their respective distal ends 44b, 54b that are disposed obliquely relative to one another such that the arms 44, 54 are asymmetrical.

[0059] The actuation interface further includes longitudinal ribs 48, 58 on the respective first and second arms 44, 54 that are configured to fit into and slide within corresponding slots or grooves 39 on the radially inward-facing surface of the distal end of the receiving interface 10.

[0060] Figure 8 is a partially exploded view of the medication delivery device 1 with the housing 3 removed. A set of antennas 80 configured to pick up signals from the electronic tag 25 is shown. Additionally, a power pack 82 comprising an electronic circuit and a battery is located at the rear end of the medication delivery device 1.

[0061] 9 is an enlarged view of the distal end 4b of the disposable cassette 4 and the receiving interface 10 before the disposable cassette 4 is inserted into the receiving interface 10. Additionally, the second arm 54 of the activation interface 40 extends toward the second switch 92. As can be seen better in the next figure, on the opposite side, the first arm 44 extends toward the first switch 90. To better view the activation interface 40, the receiving interface 10 has been removed in FIG. 10. Note that this is before the disposable cassette 4 has been inserted into the receiving interface 10. The subassembly 8 of the embodiments disclosed herein includes the activation interface 40 and the receiving interface 10.

[0062] 11 and 12, the disposable cassette 4 has been inserted into, but not yet attached to, the receiving interface 10 by rotating the disposable cassette 4 within the receiving surface 10, as discussed in connection with FIGS. 3-5. The arms 44 and 54 extend toward the respective first and second switches 90 and 92. Additionally, a spring 95 is positioned to spring-load the activation interface 40 away from the first and second switches 90 and 92.

[0063] 13 and 14, as discussed in connection with FIGS. 3-5, here the disposable cassette 4 is inserted and mounted within the receiving interface 10 by rotating the disposable cassette 4 within the receiving interface 10. As discussed, during axial rotation of the disposable cassette 4, the radially extending protrusions 19 slide on the curved distal-facing surface 30 of the receiving interface 10. This sliding action on the curved surface 30 causes distal axial movement of the disposable cassette 4 such that the distal-facing surface 29 of the protrusions 28 abuts the proximal-facing surface 47 of the actuation interface 40, pushing it distally to the position shown in FIGS. 13 and 14. The axial rotation to lock the disposable cassette 4 can be approximately 60 degrees relative to the receiving interface 10.

[0064] In FIG. 13 , one side of the device 1 is shown, with the second arm 54 of the activation interface 40 not reaching the second switch 92, which is not activated by simply attaching the disposable cassette to the receiving interface 10. However, the first arm (better shown in FIG. 14 ), which has a cutout 46 positioned asymmetrically relative to the cutout 56 of the second arm 54, reaches the first switch 90, thereby activating the first switch 90. Activating the first switch 90 activates the electronic reader in the circuit 82, which reads the electronic tag 25. The spring 95 is compressed by the axial movement of the activation interface 40 caused by the force of the disposable cassette 4 moving distally when attached to the receiving interface 10.

[0065] 15 , the disposable cassette 4 is further rotated within the receiving interface 10. The distally facing ramp 36 is positioned to interact with the surface 45 of the activation interface 40 as the disposable cassette 4 rotates further. This interaction causes the activation interface 40 to move further distally. As the activation interface 40 moves distally, the cutout 56 in the distal end 54 b of the second arm 54 reaches and activates the second switch 92. Activation of the second switch activates the plunger rod of the medication delivery device to initiate the priming action of the medication container.

[0066] 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 deactivation of the first 90 and second 92 switches depending on the degree of rotation of the disposable cassette 4, which allows the activation interface 40 to move a variable distance in the proximal direction. Further rotation in this opposite direction can remove the cassette 4 from the receiving interface 10 so that it can be discarded. A new cassette 4 can then be installed in the receiving interface 10, as described herein.

[0067] A medication delivery device (such as an autoinjector) may generally include various other components, such as a sensor unit that may recognize medication delivery events, such as when a needle is inserted into a pad attachment, an injection is initiated, and a medication delivery operation is terminated; a memory unit configured to store data recorded during the medication delivery operation; a connectivity unit configured to transmit the stored data directly to a smart device or a network; a processing unit configured to control the overall 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 and / or audio feedback.

[0068] When the medication delivery device is placed in the mounting portion, sensors within the pad are configured to recognize this event and provide feedback to the patient via tactile / visual or audio elements.

[0069] When the drug delivery is completed, the sensor is configured to recognize the event and again provide feedback to the patient. Furthermore, the collected data may be stored in the memory unit and transmitted to the smart device / network via the connectivity unit after the drug delivery event is completed.

[0070] The sensor can be one or a combination of a mechanical switch, a Hall effect sensor, an accelerometer.

[0071] A mechanical switch, a Hall effect sensor, or an accelerometer can be used to detect when a needle is inserted into the injection port.

[0072] The accelerometer can be used to detect drug delivery events.

[0073] Contemplated wireless communication methods include Bluetooth and cellular networks.

[0074] Bluetooth connectivity requires the smart device to transmit stored data to the network, and bidirectional connectivity requires a pairing action between the pad and the smart device before the supporting pad can be used. However, this is a cheaper alternative and requires less space on the PCB. Unidirectional connectivity does not require pairing.

[0075] Cellular networks do not require a pairing process and can be used as a plug-and-play device with no prior setup required, but they are expensive and require more space on the PCB.

[0076] Depending on the product requirements, either of these two techniques can be used.

[0077] Such a processing unit may include logic circuitry or control units, including microprocessors, microcontrollers, programmable digital signal processors, or other programmable devices. The processing circuitry may also, or instead, include application specific integrated circuits, programmable gate arrays or programmable array logic, programmable logic devices, or digital signal processors, respectively. Where the processing circuitry includes a programmable device, such as the microprocessors, microcontrollers, or programmable digital signal processors mentioned above, the processor may further include computer-executable code for controlling the operation of the programmable device.

[0078] The drug delivery devices described herein can be used for the treatment and / or prevention of 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 headaches, multiple sclerosis, anemia, lupus, atopic dermatitis, asthma, nasal polyps, acute hypoglycemia, obesity, anaphylaxis, and allergies. Exemplary types of drugs that can be included in the drug delivery devices described herein include, but are not limited to, antibodies, proteins, fusion proteins, peptibodies, polypeptides, pegylated proteins, protein fragments, protein analogs, protein variants, protein precursors, and / or protein derivatives. Exemplary drugs that may be included in the drug delivery devices described herein include, but are not limited to, the following (with non-limiting examples of associated diseases in parentheses): 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 (amethopterin) (rheumatoid arthritis), tocilizumab (rheumatoid arthritis), interferon Drug delivery devices described herein include, but are not limited to, pegylated interferon beta-1a (multiple sclerosis), sumatriptan (migraine), adalimumab (rheumatoid arthritis), darbepoetin alfa (anemia), belimumab (lupus), pegylated interferon beta-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 (e.g., Crohn's disease and ulcerative colitis)). Pharmaceutical formulations comprising any of the drugs described herein, for example, a pharmaceutical formulation comprising a drug listed herein (or a pharmaceutically acceptable salt of the drug) and a pharmaceutically acceptable carrier, are also contemplated for use in the drug delivery devices described herein.Pharmaceutical formulations containing the drugs listed herein (or pharmaceutically acceptable salts of the drugs) may contain one or more other active ingredients, or may be the only active ingredient present.

[0079] The inventive concept has been described primarily with reference to a few examples, however, as will be readily apparent to those skilled in the art, other embodiments than those disclosed above are equally possible within the scope of the inventive concept as defined by the appended claims.

[0080] Some aspects of the present invention are defined by the following clauses.

[0081] Clause 1. A disposable cassette (4) configured to house a drug container (13), the cassette being attachable to a drug delivery device (1) for delivering a drug to a drug delivery site via an infusion set (6) attachable to the cassette, the disposable cassette (4) comprising: a tubular body (11) adapted to receive a medication container (13) radially inside the tubular body (11), the tubular body having a through-hole (15) at a proximal end (4a) through which an adapter (17) of an infusion set can be attached to the medication container; the tubular body includes a radially extending projection (19) on a radially outwardly facing surface, the radially extending projection including a proximally facing surface (23); The disposable cassette is attachable to the proximal end (1 a) of the drug delivery device (1) by inserting the disposable cassette (4) into the proximal receiving interface (10) of the drug delivery device (1) and then axially rotating the disposable cassette so that the radially extending protrusions (19) are configured to slide over the curved distal-facing surface (30) of the receiving interface of the drug delivery device until the proximal-facing surface (23) engages the distal-facing surface (32) of the receiving interface (10) to longitudinally lock the disposable cassette (4) in an attached position within the receiving interface.

[0082] Clause 2. The disposable cassette of clause 1, including an electronic tag (25) attached to the distal end (4b) of the tubular body, the electronic tag having stored data relating to the medication stored within the body, the data being readable by an electronic reader (80) of the medication delivery device when the disposable cassette is in the attached position.

[0083] Clause 3. The disposable cassette of any one of clauses 1 and 2, comprising at least one distally extending protrusion (28) extending distally away from the distal end (4b) of the tubular body, the at least one distally extending protrusion (28) comprising a distally facing surface (29) configured to abut and push distally against an activation interface (40) of the medication delivery device (1) to cause activation of a first switch (90) that activates the electronic reader.

[0084] Clause 4. The disposable cassette of clause 3, wherein the distally extending projection (28) includes a distally facing inclined surface (36) inclined relative to the longitudinal axis (102) of the tubular body, the distally facing inclined surface (36) positioned to interact with the surface (45) of the actuation interface upon further rotation of the disposable cassette.

[0085] Clause 5. The disposable cassette of clause 4, wherein interaction of the distally facing ramp (36) with the surface (45) of the actuation interface causes the actuation interface (40) to move distally.

[0086] Clause 6. The disposable cassette of clause 5, wherein the activation interface activates the second switch (92) when moved distally by the interaction.

[0087] Clause 7. The disposable cassette of any one of clauses 1 to 6, including a second set of radially extending protrusions (34) on the radially outwardly facing surface (21) configured to engage corresponding radially inwardly facing slots (38) of the receiving interface to rotationally lock the disposable cassette within the receiving interface.

[0088] Clause 8. The disposable cassette of clause 7, wherein the second set of radially extending protrusions are longitudinal ribs (34).

[0089] Clause 9. The disposable cassette of any one of clauses 1 to 8, including an activation ring (27) removably attached radially inwardly of the tubular body (1), the activation ring including at least one distally extending projection (28).

[0090] Clause 10. The disposable cassette according to clauses 2 and 9, wherein the electronic tag (25) is attached to the activation ring (27).

[0091] Clause 11. The disposable cassette of any one of clauses 9 and 10, wherein the activation ring (27) includes two distally extending projections arranged symmetrically relative to the longitudinal axis of the tubular body.

[0092] Clause 12. The disposable cassette of any one of clauses 1 to 11, comprising a removable tamper seal sealing the through-hole (15) at the proximal end of the tubular body.

[0093] Clause 13. The disposable cassette of any one of clauses 1 to 12, comprising an annular cavity at the proximal end of the tubular body between the tubular body and the medication container, the annular cavity configured to receive the flange (22) of the adapter (17) of the infusion set (6).

[0094] Clause 14. The disposable cassette of clause 13, wherein the tubular body includes a longitudinal rib (18) facing radially inward within the cavity, the longitudinal rib adapted to rotationally lock the adapter.

[0095] Clause 15. The disposable cassette of any one of clauses 1 to 14, including a further protrusion (33) on the radially outwardly facing surface of the tubular body, the further protrusion located proximal to the radially extending protrusion (19), the further protrusion configured to abut the receiving interface (10) to limit the insertion length of the disposable cassette in the receiving interface.

[0096] Clause 16. The disposable cassette of any one of clauses 1 to 15, wherein the attachment between the disposable cassette and the receiving interface is a bayonet coupling.

[0097] Clause 18. An infusion device (100) comprising a drug delivery device according to any one of clauses 1 to 16 and a disposable cassette.

[0098] Clause 19. A subassembly (2) for a drug delivery device, comprising: a proximal receiving interface (10) adapted to receive a cassette containing a medication container, the proximal receiving interface including a curved distal-facing surface (30) adapted to receive and slidably guide radially extending projections (19) of the cassette distally as the cassette is rotated axially relative to the receiving interface until a proximal-facing surface (23) of the cassette engages a distal-facing surface (32) of the receiving interface to longitudinally lock the disposable cassette in an attached position within the receiving interface; and an activation interface (40) including a proximally facing surface (47) adapted to receive a distally extending protrusion (28) of the cassette, wherein when the activation interface (40) is pushed distally by the cassette, it causes activation of a first switch (90) of the subassembly to activate an electronic reader that reads the electronic tag of the cassette.

[0099] Clause 20. The subassembly of clause 19, wherein the activation interface includes first (44) and second (54) distally extending arms that extend toward respective first (90) and second switches (92), the first arms reaching the first switch and causing activation of the first switch when the activation interface is moved distally.

[0100] Clause 21. The subassembly of clause 20, wherein the actuation interface includes a ramp (45) adapted to receive a distally extending protrusion (28) of the cassette as the cassette is further rotated within the receiving interface (10), whereby interaction between the distally facing surface of the cassette and the ramp of the actuation interface causes the actuation interface to move distally.

[0101] Clause 22. The subassembly of clause 21, wherein distal movement of the annular actuation interface (40) causes the second arm (54) to reach and actuate the second switch (92).

[0102] Clause 23. The subassembly of any one of clauses 20-22, wherein the distal ends of the first arm and the second arm are asymmetrical.

[0103] Clause 24. The subassembly of any one of clauses 19 to 23, including a spring (95) positioned to spring-load the activation interface away from the first switch and the second switch.

[0104] Clause 25. A drug delivery device (1) comprising a subassembly according to any one of clauses 19 to 24.

Claims

1. A subassembly (2) for a drug delivery device, comprising: a proximal receiving interface (10) adapted to receive a cassette containing a medication container of the medication delivery device, the proximal receiving interface including a curved distal-facing surface (30) adapted to receive and slidably guide radially extending projections (19) of the cassette distally as the cassette rotates axially relative to the receiving interface until a proximal-facing surface (23) of the cassette engages a distal-facing surface (32) of the receiving interface to longitudinally lock the cassette in an attached position within the receiving interface; and an activation interface (40) including a proximally facing surface (47) adapted to receive a distally extending protrusion (28) of the cassette, wherein when the activation interface (40) is pushed distally by the cassette, it causes activation of a first switch (90) of the subassembly to activate an electronic reader that reads an electronic tag of the cassette.

2. 2. The subassembly of claim 1, wherein the activation interface includes first (44) and second (54) distally extending arms that extend toward respective first (90) and second switches (92), the first arms reaching the first switches and causing activation of the first switches when the activation interface is moved distally.

3. 3. The subassembly of claim 2, wherein the actuation interface includes a ramp (45) adapted to receive the distally extending protrusion (28) of the cassette as the cassette rotates further within the receiving interface (10), whereby interaction between the distally facing surface of the cassette and the ramp of the actuation interface causes the actuation interface to move distally.

4. The subassembly of claim 5, wherein distal movement of the annular actuation interface (40) causes the second arm (54) to reach and actuate the second switch (92).

5. The subassembly of any one of claims 2 to 4, wherein the distal ends of the first and second arms are asymmetrical.

6. The subassembly of any one of claims 1 to 5, including a spring (95) arranged to spring-load the activation interface away from the first switch and the second switch.

7. The cassette (4) is configured to accommodate a drug container (13), the cassette being attachable to a drug delivery device (1) for delivering a drug to a drug delivery site via an infusion set (6) attachable to the cassette, the cassette (4) comprising: a tubular body (11) adapted to receive the medication container (13) radially inside the tubular body (11), the tubular body having a through hole (15) at a proximal end (4a) through which an adapter (17) of the infusion set can be attached to the medication container; the tubular body includes the radially extending projections (19) on a radially outwardly facing surface, the radially extending projections including the proximally facing surface (23); The disposable cassette is attachable to the proximal end (1 a) of the medication delivery device (1) by inserting the disposable cassette (4) into the proximal receiving interface (10) of the medication delivery device (1) and then axially rotating the disposable cassette (4), whereby the radially extending protrusions (19) are configured to slide over the curved distal-facing surface (30) of the receiving interface of the medication delivery device until the proximal-facing surface (23) engages the distal-facing surface (32) of the receiving interface (10) to longitudinally lock the disposable cassette (4) in an attached position within the receiving interface. A subassembly according to any one of claims 1 to 6.

8. 8. The subassembly of claim 7, wherein the cassette (4) includes an electronic tag (25) attached to the distal end (4b) of the tubular body, the electronic tag having stored data related to the medication stored within the body, the data being readable by an electronic reader (80) of the medication delivery device when the disposable cassette is in the attached position.

9. 9. A subassembly according to claim 7 or 8, wherein the cassette (4) is disposable.

10. 10. The subassembly of any one of claims 7 to 9, wherein the cassette (4) includes a second set of radially extending protrusions (34) on the radially outwardly facing surface (21) configured to engage corresponding radially inwardly facing slots (38) of the receiving interface to rotationally lock the disposable cassette within the receiving interface.

11. A subassembly according to any one of claims 7 to 10, wherein the second set of radially extending projections are longitudinal ribs (34).

12. 12. The subassembly of claim 7, wherein the cassette (4) includes an actuation ring (27) removably mounted radially inward of the tubular body (1), the actuation ring including the at least one distally extending protrusion (28).

13. A subassembly according to any one of claims 7 to 12 when dependent on claim 8, wherein the electronic tag (25) is attached to the activation ring (27).

14. The subassembly of any one of claims 7 to 13, wherein the cassette (4) includes an annular cavity at the proximal end of the tubular body between the tubular body and the drug container, the annular cavity configured to receive a flange (22) of the adapter (17) of the infusion set (6).

15. A drug delivery device (1) comprising a subassembly according to any one of claims 1 to 14.

Images