Drug cassette

Abstract

This disclosure relates, in general, to drug delivery devices such as auto-injectors or injectors, and more particularly to drug cassettes configured to house drug containers.

Description

Technical Field

[0001] The present disclosure generally relates to drug delivery devices such as self-injectors or syringes, and more particularly to a drug cassette configured to house a drug container.

Background Art

[0002] Many medical conditions require injections. In recent years, there are various injection devices, including various types of pen injectors, self-injectors, and infusion devices for large-volume infusion. 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. The difficulties faced by patients who require frequent injections, and particularly those who need to inject highly viscous drugs, are of particular importance. In considering these problems, the applicant understands that various developments are possible, for example, more effective means for administering larger injection volumes, to help improve currently commercially available drug delivery devices, and these developments are described in detail below.

Summary of the Invention

[0003] An object of the present disclosure is to provide a drug cassette for a drug delivery device that solves or at least alleviates the problems of the prior art.

[0004] According to a first aspect of the present disclosure, a drug cassette is provided, configured to house a drug container, the drug cassette being attachable to a drug delivery device for delivering a drug to an injection site via an infusion set connected to the drug cassette, the drug cassette reaching between a distal and proximal end along a longitudinal axis, the cassette comprising: a cassette body adapted to receive a drug container in a cylindrical internal space of the main body of the cassette, the cassette body having a through hole at its proximal end through which an adapter of an infusion set is connected to the drug container; a rear cap including a rear end plate at the distal end; at least one slider arm extending proximal to the rear end plate of the rear cap, the at least one slider arm being located inside the cassette body; and an actuator movable relative to the cassette body, the actuator being mechanically connected to the slider arm such that the movement of the actuator causes a sliding distal movement of the slider arm relative to the cassette body.

[0005] Embodiments of this disclosure advantageously provide a drug cassette for housing drug containers. The drug cassette can be attached to a drug delivery device by inserting it into a receiving interface and locking the drug cassette into the mounting position of the receiving interface. Individual drug cassettes allow for varying drug amounts using the same drug delivery device. Therefore, the volume of the drug container can range from a small volume of about 2 mL to a large volume of about 10 mL or more, depending on the size of the drug cassette.

[0006] According to one embodiment, an actuator capable of causing the sliding movement of a slider arm is advantageously used for initiating and pausing injection. When a drug cassette is attached to a drug delivery device and the slider arm is moved distally, the distal protruding position of the slider arm triggers the electric drug delivery device by pressing the switch activator of the electric drug delivery device, thereby initiating injection. By moving the slider arm proximal back, the injection is paused.

[0007] Furthermore, according to one embodiment, the slider arm may be part of the rear cap. In this embodiment, an actuator capable of causing the sliding movement of the rear cap is advantageously used for initiating and pausing injection. When the drug cassette is attached to the drug delivery device and the rear cap is moved distally, the distal protruding position of the rear cap triggers the electric drug delivery device by pressing the switch activator of the electric drug delivery device, thereby initiating injection. By moving the rear cap proximal back, the injection is paused.

[0008] 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 portion / distal end” is used, it refers to the part / end of the delivery device, or part / end of its component, that is 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 toward the dose delivery site during use of the drug delivery device. When the term “proximal portion / proximal end” is used, it refers to the part / end of the delivery device, or part / end of its component, that is furthest away from the dose delivery site during use of the drug delivery device.

[0009] Furthermore, the terms “longitudinal,” “longitudinally,” “axially,” or “axial” refer to the direction extending from the proximal end to the distal end, typically along the device or its components, in the direction of the longest extension of the device and / or components.

[0010] Similarly, the terms "transverse," "transversal," and "transversally" refer to a direction that is generally perpendicular to the longitudinal direction.

[0011] Furthermore, the terms “circumference,” “circumferential,” and “circumferentially” refer to the circumferential or circumferential direction 301 with respect to the axis 102, typically the central axis extending in the longest direction of the device and / or component. Similarly, “radial” or “radially” refers to the direction 302 extending radially with respect to the axis, and “rotation,” “rotational,” and “rotationally” refer to rotation with respect to the axis.

[0012] According to one embodiment, the cassette body includes at least one slot on opposite sides of the cassette body, and the slot has a main extension parallel to the longitudinal axis of the drug cassette.

[0013] According to one embodiment, the rear cap includes at least one radially outward-extending projection positioned within a slot in the cassette body.

[0014] According to one embodiment, at least one slider arm is an integral part of the rear cap.

[0015] According to one embodiment, the rear cap may include at least one flexible arm, the at least one flexible arm extending radially outward inclined to initially prevent distal movement of the rear cap relative to the cassette body. The flexible arm may have a fixed proximal end and a free distal end, the free distal end being movable relative to the fixed proximal end. Advantageously, the free end of the flexible arm abuts against a proximal-facing surface of the cassette body, thereby preventing distal movement of the rear cap before engagement with the acceptance interface of the drug delivery device.

[0016] According to one embodiment, the flexible arm may bend radially inward through interaction with the receiving interface of the drug delivery device, thereby releasing the rear cap from the cassette body and making it movable distally relative to the cassette body. Advantageously, during the engagement procedure for connecting the drug cassette to the drug delivery device, the flexible arm is moved through interaction with the receiving interface, thereby releasing the rear cap and allowing distal movement. Advantageously, the rear cap cannot move distally before connecting it to the drug delivery device in order to ensure that the drug container remains in place within the cassette body.

[0017] According to one embodiment, the rear cap may include an actuator, which is a sliding button interface, for the user to slide the rear cap distally. In other words, the sliding button interface may be part of the rear cap, as it is integrated with the rear cap. Alternatively, the actuator, for example, the sliding button interface, may be part of a slider arm. In another embodiment, the sliding button interface may consist of parallel ribs on the surface of the rear cap that the user may press distally to slide the rear cap distally.

[0018] In one embodiment where the slider arm is an independent component of the rear cap, it should be noted that the movement of the rear cap as described above is performed by the slider arm.

[0019] According to one embodiment, the rear cap may include a proximal surface that abuts the distal surface of the drug container to prevent the drug container from coming out of the distal end of the cassette body. The rear cap includes a through-hole that allows the plunger rod of the drug delivery device to enter the cassette body and compress the drug container. The through-hole may be smaller than the external dimensions of the drug container, thereby preventing the drug container from falling out of the cassette body.

[0020] According to one embodiment, at least one slot may include a first portion, a second portion, and a constricted portion between the first and second portions. The constricted portion is narrower than the outer dimensions of at least one radially outward-extending projection of the rear cap.

[0021] According to one embodiment, at least one radially outward-extending projection of the rear cap may be longitudinally lockable in each of the first and second portions. The constricted portion provides a snap-lock function for longitudinally releasing the at least one radially outward-extending projection in the first and second portions. The snap-lock function provides tactile feedback to the user when moving the rear cap between two positions, one of which is the rear cap protruding distally.

[0022] According to one embodiment, the cassette body may include a through-hole for receiving an actuator in the form of a rotatable button, the rotatable button including at least one radial projection reaching at least one slider arm of the rear cap inside the cassette body. The button may be a component separable from the rear cap. The rotatable button is incorporated into the cassette body and rotated to move the rear cap distally.

[0023] According to one embodiment, at least one slider arm may include a cam surface against which a radial projection contacts when a rotatable button is rotated, and the interaction between the radial projection of the rotatable button and the cam surface causes distal movement of the rear cap.

[0024] According to one embodiment, the cassette body may include two grooves on a sleeve of the cassette body surrounding a through-hole, and the rotary button includes at least one projection that can be releasably engaged with each of the two grooves in two different directions of rotation of the rotary button relative to the through-hole. The at least one projection and the corresponding groove provide a snap-lock function that provides tactile feedback to the user when the rotary button is rotated for operation.

[0025] According to one embodiment, the two rotational directions may be separated by approximately 90 degrees.

[0026] According to one embodiment, the slots may be uniformly shaped. That is, when a rotatable button is used, the slots for the protrusions of the rear cap may be uniform without a constricted portion.

[0027] According to one embodiment, the cassette body may include a radially inwardly extending protrusion configured to prevent the drug container from exiting the distal end of the cassette body.

[0028] According to one embodiment, the rear cap may include a rear end plate having a longitudinal through-hole for receiving the plunger rod from the drug delivery device.

[0029] According to one embodiment, the drug cassette may be attachable to the proximal end of the drug delivery device by insertion of the drug cassette into the proximal receiving interface of the drug delivery device, and by subsequent axial rotation of the drug cassette, the surface facing distally of the cassette body engages with the surface facing proximally of the receiving interface, locking the drug cassette longitudinally in the attachment position within the receiving interface.

[0030] In general, all terms used in the claims should be construed according to their ordinary meanings in the art, unless explicitly defined otherwise herein. All references to "a / an / the member, apparatus, component, means, etc." shall be construed, without limitation, as referring to at least one instance of the member, apparatus, component, means, etc., unless specifically specified otherwise.

Brief Description of the Drawings

[0031] Hereinafter, specific embodiments of the concepts of the present invention will be described by way of example with reference to the accompanying drawings. [Figure 1] This is a perspective view of an electric drug delivery device, a drug cassette, and an infusion set according to embodiments of the present disclosure. [Figure 2] This is an exploded view of a drug cassette according to an embodiment of the present disclosure. [Figure 3A] This is a perspective view of the rear cap according to an embodiment of the present disclosure. [Figure 3B] This is a perspective view of the rear cap according to an embodiment of the present disclosure. [Figure 4A] This is a perspective view of the cassette body according to an embodiment of the disclosure. [Figure 4B] This is a perspective view of the cassette body according to an embodiment of the disclosure. [Figure 5] This is a perspective view of a drug cassette according to an embodiment of the present disclosure. [Figure 6] This is a perspective view of the acceptance interface according to an embodiment of the disclosure. [Figure 7] This is a perspective view of the rear cap according to an embodiment of the present disclosure. [Figure 8A] This is a perspective view of the cassette body according to an embodiment of the disclosure. [Figure 8B] This is a perspective view of the cassette body according to an embodiment of the disclosure. [Figure 9] This is a perspective view of a rotatable button according to an embodiment of the present disclosure. [Figure 10] This is a perspective view of a drug cassette according to an embodiment of the present disclosure. [Figure 11] This is a perspective view of a drug cassette according to an embodiment of the present disclosure. [Figure 12] This is a perspective view of the proximal end of a drug cassette according to an embodiment of the disclosure. [Figure 13A] This is a perspective view of a drug cassette attached to the receiving interface of a drug delivery device according to an embodiment of the present disclosure. [Figure 13B] This is a perspective view of a drug cassette attached to the receiving interface of a drug delivery device according to an embodiment of the present disclosure. [Figure 14A]This is a perspective view of a drug cassette attached to the receiving interface of a drug delivery device when the rear cap has moved distally, according to an embodiment of the present disclosure. [Figure 14B] This is a perspective view of a drug cassette attached to the receiving interface of a drug delivery device when the rear cap has moved distally, according to an embodiment of the present disclosure. [Figure 15A] This is a cross-sectional view of a drug cassette according to an embodiment of the disclosure. [Figure 15B] This is an exploded view of a spring holder and spring according to an embodiment of the present disclosure. [Figure 16A] This is a cross-sectional view of a drug cassette according to an embodiment of the disclosure. [Figure 16B] This is an exploded view of the distal spring holder and spring according to an embodiment of the present disclosure. [Figure 17A] This is a cross-sectional view of a drug cassette according to an embodiment of the disclosure. [Figure 17B] This is a perspective view of a disc spring according to an embodiment of the present disclosure. [Figure 18A] This is a cross-sectional view of a drug cassette according to an embodiment of the disclosure. [Figure 18B] This is a perspective view of a polymer spring according to an embodiment of the present disclosure. [Figure 19] This is a cross-sectional view of a drug cassette according to an embodiment of the disclosure. [Figure 20] This is a cross-sectional view of a drug cassette according to an embodiment of the disclosure. [Figure 21] This is a perspective view of a drug cassette according to another embodiment of the present disclosure. [Figure 22] This is a perspective view of a drug cassette according to another embodiment of the present disclosure. [Figure 23] This is a perspective view of a drug cassette according to another embodiment of the present disclosure. [Figure 24] This is a perspective view of a drug cassette according to another embodiment of the present disclosure. [Figure 25] This is a perspective view of a drug cassette according to another embodiment of the present disclosure. [Figure 26]This is a perspective view of a drug cassette according to another embodiment of the present disclosure. [Figure 27] This is a perspective view of a drug cassette according to another embodiment of the present disclosure. [Figure 28] This is a perspective view of a drug cassette according to another embodiment of the present disclosure. [Figure 29] This is a perspective view of a drug cassette according to another embodiment of the present disclosure. [Figure 30] This is a perspective view of a drug cassette according to another embodiment of the present disclosure. [Modes for carrying out the invention]

[0032] The concept of the present invention will be further described below with reference to the accompanying drawings illustrating 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 this description, similar numbers refer to similar components.

[0033] Figure 1 shows an example of an electric drug delivery device 1, such as an auto-injector or infusion device 100, according to an embodiment of the present disclosure. The drug delivery device 1 is configured to dispense a drug from a drug container to the user at a dose delivery site via a drug delivery member such as a needle 2. The drug delivery device 1 extends from a proximal end 1a to a distal end 1b with respect to an axis 102.

[0034] The drug delivery device 1 includes a housing 3 and is connectable to a drug cassette 4 having a proximal end 4a and a distal end 4b.

[0035] The drug cassette 4 can be connected to an infusion set 6, which includes a flexible tube 7 connected to a through-hole in the drug cassette 4 at its proximal end 4a. A needle 2 is attached to the other end of the tube 7 via a pad 8.

[0036] The drug cassette 4 is adapted to accommodate drug containers of various capacities, for example, ranging from approximately 1 mL to approximately 10 mL.

[0037] The drug delivery device 1 includes an acceptance interface 10 configured to accept a disposable cassette and lock onto the proximal end 1a of the drug delivery device 1.

[0038] The infusion set 6 includes an adapter 11 for attaching the infusion set to the proximal end 4a of the drug cassette 4, so that drugs from drug containers contained in the drug cassette 4 can be injected into the infusion set.

[0039] In one example, the flexible tube includes a connector at its distal end. The tube's connector is configured to connect to an adapter 11. In a preferred example, the adapter 311 is configured to engage with the tube's connector via threads 311c, as shown in Figure 23. In a preferred example, the adapter 311 includes a protruding channel 311b configured to be at least partially positioned within the distal end of the tube.

[0040] Figure 2 is an exploded view of the drug cassette 4 according to an embodiment of the present disclosure.

[0041] The drug cassette 4 includes a cassette body 12 adapted to receive a drug container 14 in the cylindrical internal space of the cassette body 12. A plunger rod adapter 16, such as a rubber stopper, may be fitted onto the tubular drug container 14. The plunger rod adapter 16 is adapted to be pushed proximal by the plunger rod of the drug delivery device during a drug delivery event. This proximal movement of the plunger rod adapter 16 causes the drug to be discharged from the drug container 14.

[0042] The cassette body 12 has a through hole 18 at its proximal end 12a, and at the proximal end 12a, the adapter 11 of the infusion set 6 is connected to the drug container 14. For example, the infusion set 6 can be attached to the drug container 14 as disclosed in the following example. Alternatively, the infusion set, i.e., the adapter 11 and tubing 7, may be pre-assembled on the drug container.

[0043] In one example, the cassette body 12 further includes at least one slot 19 having a main extension parallel to the longitudinal axis 102 of the drug cassette 4.

[0044] The drug cassette 4 includes a rear cap 20 with a rear end plate 22 at its distal end 20b, and at least one slider arm 24 extending proximal from the distal end 20b of the rear cap 20. The rear cap 20 further includes at least one radially outward-extending projection 26 positioned to be positioned within each slot 19 of the cassette body 12. When assembled, at least one slider arm 24 of the rear cap 20 is positioned inside the cassette body 12 and is sandwiched between the drug container 14 and the cassette body 12.

[0045] It should be noted that the slider arm 24 may be an integral part of the rear cap 20. Alternatively, the slider arm 24 may be an independent component of the rear cap, in which case the rear cap may be fixedly attached to the cassette body 12. Preferably, in one example where the slider arm is an independent component of the rear cap, the slider arm is configured to move distally to the rear cap to interact with the drug delivery device 1.

[0046] The drug cassette 4 further includes an actuator 28 that is movable relative to the cassette body 12. The actuator 28 is mechanically connected to the rear cap 20 such that the movement of the actuator 28 causes the rear cap 20 to slide distally relative to the cassette body 12.

[0047] Figures 3A and 3B are perspective views of a rear cap 20 according to an embodiment of the present disclosure. The rear cap 20 includes two opposing slider arms 24. Each of the slider arms 24 includes an actuator 28, which is a sliding button interface 30 for the user to slide the rear cap 20 distally. The sliding button interface 30 includes a pair of transverse ribs 32 to allow the user to better grasp the sliding button interface 30 with their fingers.

[0048] The rear cap 20 further includes two opposing radially outward-extending projections 26 intended to engage with the respective slots of the cassette body 12. The projections 26 include rounded portions 34. Proximal to the projections 26 are inclined surfaces 36 with respect to the longitudinal axis 102, having a slope that joins to the radially outermost part of the projections 26. The inclined surfaces 36 facilitate engagement of the projections 26 with the slots 19 of the cassette body when attaching the rear cap 20 to the cassette body 12.

[0049] The longitudinal through-hole 38 in the rear end plate 22 allows a plunger rod from the drug delivery device to penetrate into the drug cassette and release the drug from the drug container 14.

[0050] Furthermore, the rear cap 20 includes at least one flexible arm 40, preferably one flexible arm 40 for each slider arm 24. At least one flexible arm 40 extends inclined radially outward to initially prevent distal movement of the rear cap 20 relative to the cassette body 12.

[0051] In some embodiments, the rear cap 20 includes a proximal-facing surface 42 which is part of an annular flange 44 attached to the rear plate 22. The proximal-facing surface may abut the distal surface of the drug container 14 to prevent the drug container from coming out of the distal end 20b of the cassette body. In other words, the diameter of the annular flange 44 is smaller than the diameter of the drug container 14.

[0052] The rear cap 20 includes at least one protrusion 47 configured to releasely lock the drug cassette 4 with a bayonet connection to the receiving interface 10 of the drug delivery device 1.

[0053] Figures 4A and 4B are perspective views of the cassette body 12 according to one embodiment.

[0054] The cassette body 12 includes a proximal surface 46, and the free end of the flexible arm 40 abuts against the proximal surface 46, thereby preventing the rear cap 20 from moving distally to the cassette body 12. This further ensures that the drug container 14 is fixed inside the drug cassette 4.

[0055] The cassette body 12 further includes opposing slots 19, each slot 19 comprising a first portion 19a, a second portion 19b, and a constricted portion 19c between the first and second portions. The first portion 19a and the second portion 19b are circular in shape to accommodate the circular projection 26 of the rear cap 20. Furthermore, the transverse width of the slot 19 in the constricted portion 19c is smaller than the corresponding widths of the first portion 19a and the second portion 19b. In addition, the width of the constricted portion 19c is smaller than the width of the circular projection 26 of the rear cap 20, thereby providing a snap-in interface between the rear cap 20, which includes a sliding button interface 30, and the cassette body 12.

[0056] The snap-in interface between the rear cap 20 and the cassette body 12 provides longitudinal locking of the radially outward-extending projections 26 of the rear cap 20 in each of the first portion 19a and the second portion 19b. That is, the projections 26 may abut against the proximal surface 48a of the first portion 19a or the distal surface 48b of the second portion 19b, thereby restricting longitudinal movement between the rear cap 20 and the cassette body 12.

[0057] The cassette body 12 may optionally further include a radially inwardly extending projection 45 configured to prevent the drug container 14 from coming out of the distal end of the cassette body 12.

[0058] Figure 5 is a perspective view of the drug cassette 4. The rear cap 20 is mounted inside the cassette body 12, and in this configuration, the rear cap 20 is positioned at its most distal location, along with the projection 26 in the second portion 19b of the slot 19. Furthermore, the flexible arm 20 is positioned radially outward so as to abut against the proximal surface 46 of the cassette body 12 when the rear cap 20 attempts to move distally. The sliding button interface 30 is accessible through the opening 50 of the cassette body 12.

[0059] Figure 6 is a perspective view of the receiving interface 10 of the drug delivery device 1. The receiving interface 10 allows for bayonet locking of the drug cassette 4 within the interface 10. In one example, the drug cassette 4 is inserted into the receiving interface 10 and rotated clockwise axially in the perspective view shown in Figure 6 until the projection 47 of the rear cap 20 reaches the groove 13 or trench of the receiving interface 10. 15. In this position, the proximal surface 46 of the cassette body 12 engages with the distal surface 49 of the receiving interface 10, longitudinally locking the drug cassette 4 in its mounting position within the receiving interface 10.

[0060] In this position, the radially outward-extending flexible arm 40 of the rear cap is bent or pushed inward by the inclined surface 52, thereby allowing the rear cap 20 to move distally by operation using the slider button interface 30. In this way, the flexible arm 40 bends radially inward in interaction with the receiving interface 10 of the drug delivery device 1, thereby making the rear cap 20 movable distally relative to the cassette body 12. As shown in Figures 21 and 29, the lock formed by the proximal-facing surface 46 of the cassette body 12 and the flexible arm 40 can be used in other embodiments described below.

[0061] Figure 7 is a perspective view of the rear cap 220 according to an embodiment. The rear cap 220 shares some features with the rear cap 20, which will not be repeated here. However, the rear cap 220 does not have the flexible arm 40 described above.

[0062] At least one slider arm 24 of the rear cap 220 includes a cam surface on the proximal end of the slider arm 24. Furthermore, the slider arm 24 includes a lock groove 56 or cavity.

[0063] Figure 8A is a perspective view of the cassette body 212. In this embodiment, the slot 219 is uniformly molded and configured to receive the projection 26 of the rear cap 220.

[0064] Furthermore, the cassette body 212 includes a through-hole 58 for receiving an actuator in the form of a rotatable button as shown in Figure 9. The cassette body 212 includes two grooves 60a, 60b on the sleeve 62 of the cassette body 212. The sleeve 62 surrounds the through-hole 58 and allows the button to rotate within the sleeve 62. The two directions of rotation are separated by approximately 90 degrees.

[0065] Figure 8B is a perspective view of the distal end of the cassette body 212. The cassette body 212 includes a radially inward-extending projection 57 configured to prevent the drug container from coming out of the distal end of the cassette body. The proximal-facing surface of the projection 57 may contact the drug container when it reaches the projection 57. The radially inward-extending projection 57 bends radially outward, allowing the drug container to be inserted into the cassette body 212.

[0066] Figure 9 is a perspective view of the rotatable button 64. The rotatable button includes a handle 66, an intermediate section 58, and a pair of opposing radial projections 70a-b. The intermediate section 58 connects the handle 66 to the projections 70a-b. The projections 70a-b form a similar shape but fit into the sleeve 62 of the cassette body 212 through a through hole 58. The intermediate section 58 is disc-shaped so that the rotatable handle 64 can rotate conveniently within the sleeve 62 when the projections 70a-b are inserted through the through hole 58.

[0067] When the rotatable button 64 is first inserted into the through hole 58, it is not locked in place. In this embodiment, a 45-degree clockwise rotation causes the radially inward projections 72a, b of the handle 66 to snap into the groove 60a of the sleeve 62. This further results in a misalignment between the shape of the through hole 58 and the projections 70a-b, so that the rotatable button 64 is locked within the through hole 58 but can still be rotated.

[0068] As the rotatable button 64 is rotated further, the projections 72a and 72b become releasably engaged in the grooves 60b. In other words, the projections 72a and 72b are releasably engaged in the respective grooves 60a and 72b in two different directions of rotation of the rotatable button 64 relative to the through hole 58.

[0069] Figure 10 is a perspective view of a drug cassette 204, which includes a rear cap 220, a cassette body 212, and a rotatable button 64 rotated to an initial 45-degree position with projections 72a-b in groove 60a. The drug cassette 204 is locked to the receiving interface 10 of the drug delivery device via a bayonet coupling.

[0070] Figure 11 shows a bottom view of the drug cassette 204 with the drug container removed. The radial projections 70a-b of the rotatable button 64 reach at least one slider arm 24 on the rear cap 220 inside the cassette body 212. When the rotatable button 64 is rotated from a 45-degree position to a 90-degree position, the projections 72a-b engage with the groove 60b, and one of the projections 70a-b contacts the cam surface 54, thereby causing distal movement of the rear cap 220.

[0071] Referring to Figure 12, the proximal end 4b of the drug cassette 4, 204 is shown. Regardless of whether the actuator is the rotatable button 64 of the slider button 30, the actuation moves the rear cap 20, 220 distally relative to the cassette body 12, 212, as shown in Figure 12, where the rear cap 20, 220 moves a distance D relative to the cassette body 12, 212.

[0072] Figures 13A and 13B are two perspective views of the drug cassette 4 attached to the receiving interface 10 and in contact with the switch activator 74 of the drug delivery device 1. The switch activator 74 includes two opposing arms 76a and 76b, each arm having its own proximal projection 78a and 78b, each including an inclined surface 80. One of the projections 78a and its inclined surface 80 is also shown inside the receiving interface 10 in Figure 6. When the drug cassette is rotated to the locked position within the receiving interface, the inclined surface 80 interacts with the side surface 82 of the projection 84 on the rear cap 20 (or rear cap 220).

[0073] The interaction between the inclined surface 80 and the corresponding side surface 82 causes the switch activator 74 to move distally. The first 44 and the second distally extending arms 76a-b each include cutouts 86a-b on their respective distal ends 88a-b, which are positioned obliquely to each other so that the arms 76a-b are asymmetrical. In Figures 13A-13B, since the switch activator 74 has moved distally, arm 76a is activating switch 90, but the opposing switch 92 is within the cutout 88b and therefore not yet activated. The activation of the first switch 90 may cause the electronic reader of the drug delivery device 1 to activate, for example, to read the electronic tag of the drug container in the drug cassette 4.

[0074] Figures 14A and 14B show two perspective views of the drug cassette 4 mounted on the receiving interface 10 when the actuator of the drug cassette 4 causes distal movement, distance D of the rear cap 20. The projection 26 is moving to the more distal portion of the slot 19. In this embodiment, the projection 26 is moving from the second portion 19b to the first portion 19a of the slot 19. The distal movement of the rear cap 20 pushes the switch activator further distally, so that the distally extending arm 76b activates the switch 92 of the drug delivery device 1, which controls the plunger rod of the drug delivery device 1 to apply force to the drug container in the drug cassette 4, causing the drug to be dispensed for injection. When the actuators 30 and 64 of the drug cassette 4, 204 are reversed, and the rear cap 20, 220 is moved proximal to the cassette body 12, 212, the switch 92 is deactivated and injection is paused.

[0075] The plunger rod of drug delivery device 1 may be driven by a stepper motor powered by a battery. The stepper motor is current-controlled, and the current is locked to a sufficiently high value for various types of injections. This means that energy consumption is nearly constant regardless of motor speed and the mechanical work performed by the motor. Providing long infusion times, such as 10 minutes or longer, means that the motor operates at a low speed, resulting in very low efficiency in terms of mechanical work and / or electrical energy consumption, which may lead to motor overheating. Furthermore, at very low motor speeds, it is difficult to detect motor stalls (Stallguard). Operation without stallguard risks losing a large number of motor steps because it cannot detect and compensate for them. This could mean that the injection is not completed because the software incorrectly assumes that the plunger rod has reached its end position, while steps are actually lost along the way.

[0076] To mitigate this problem, a drug cassette according to any of the embodiments described herein may include an elastic member positioned within the drug cassette along its longitudinal axis. The elastic member is compressible by the force provided by the plunger rod of the drug delivery device during injection and is configured to restore to its original position during motor rest periods, thereby allowing the plunger rod to move proximal to the device.

[0077] In one embodiment shown in the cross-sectional view of Figure 15A, the elastic member is an optionally pre-tensioned spring 110 positioned between the distal spring holder 112 and the proximal spring holder 114. Figure 15B is an exploded view of the spring holders 112, 114 and the spring 110. The proximal spring holder 114 includes a central cylinder 116 into which the spring 110 is screwed. The plunger rod of the drug delivery device 1 pushes the distally facing surface 118 of the distal spring holder 112, moving the rubber stopper 16 proximal. When the motor stops moving the plunger rod forward, the spring 110 returns to its original position between the spring holders 112 and 114, moving the rubber stopper further proximal, thereby limiting the maximum force applied to the lead screw of the stepper motor. This also allows for an additional safety margin to prevent the motor from stopping if the compression stroke of the spring is greater than the intended motor stroke, thereby increasing the efficiency of the system.

[0078] In one embodiment shown in the cross-sectional view of Figure 16A, the elastic member is an optionally pre-tensioned spring 110 positioned between the distal spring holder 120 and the distally facing surface 122 of the rubber stopper 16, in direct contact with it. Figure 16B is an exploded view of the somewhat conical spring 110 and distal spring holder 120. The distal spring holder 120 includes a proximal spring adapter 121 that snaps longitudinally into the spring. The plunger rod of the drug delivery device 1 pushes the distally facing surface 124 of the distal spring holder 120, moving the rubber stopper 16 proximal. When the motor stops moving the plunger rod forward, the spring 110 returns to its original position between the distal spring holder 120 and the rubber stopper 16, moving the rubber stopper 16 further proximal.

[0079] In one embodiment shown in the cross-sectional view of Figure 17A, the elastic member is a disc spring 128 press-fitted into the cavity of the rubber stopper 16. The disc spring 128 is somewhat curved to provide spring elasticity. Figure 17B is a perspective view of the disc spring 128, which includes radial notches 130 to facilitate deformation of the metal disc spring during compression. When in use, the plunger rod of the drug delivery device 1 pushes the distally facing surface 130 of the distal spring holder 112, moving the rubber stopper 16 proximal. When the motor stops, the disc spring 128 returns to its original position between the plunger rod and the rubber stopper 16, moving the rubber stopper 16 further proximal.

[0080] In one embodiment shown in the cross-sectional view of Figure 18A, the elastic member is a polymer spring 130 fitted into the cavity of the rubber stopper 16. Figure 18B is a perspective view of the polymer spring 130 including a pair of parallel rings 132 interconnected by ribs 134. During use, the plunger rod of the drug delivery device 1 pushes the distally facing surface 134 of the polymer spring 130, moving the rubber stopper 16 proximal. When the motor stops, the polymer spring 130 returns to its original position between the plunger rod and the rubber stopper 16, moving the rubber stopper 16 further proximal.

[0081] In one embodiment shown in the cross-sectional view of Figure 19, the elastic member is a deformable cavity 140 of the rubber stopper 16. The deformable cavity is formed between the plunger rod 142 and the rubber stopper 16. In this way, a portion of the rubber stopper 16 can bend when the plunger adapter 17 presses against it.

[0082] In one embodiment shown in the cross-sectional view of Figure 20, the elastic member is a spring 144 positioned between the drug container 14 and the distally facing surface 146 of the cassette body 12, 212. Since the drug container 14 is not directly connected to the needle but instead to the infusion set, the movement of the drug container during injection does not affect the patient's injection experience, and the movement can be concealed by extending the cassette body 12, 212 over the drug container 14. The spring can also reduce or even eliminate rattle between the drug container and the cassette body 12, 212.

[0083] Figures 21-28 and 29-30 show another embodiment of the cassettes 304 and 403, which does not have the slots 19 and 219 of the cassette body as disclosed in the above embodiment. The rear cap 320 shares several features with the rear cap 20, such as the flexible arm 40, which have been described above and will not be repeated here. Furthermore, the projection 47 of the cassette body 312 disclosed here is also the same as the projection 47 disclosed above. Instead of having two slider arms 24 as disclosed in the first embodiment, the rear cap 320 in this embodiment includes one slider arm 234. The slider arm 234 includes an actuator which is a sliding button interface 330 for the user to slide the rear cap 320 distally. The sliding button interface 330 includes a transverse projection so that the user can better grip the sliding button interface 330. Alternatively, or additionally, the sliding button interface 430 includes a gripping pattern, such as a rubber gripping pattern and / or ribs, as shown in Figure 29. In one example, the slider arms 234, 434 are integral parts of the sliding button interfaces 330, 430. In one example, the slider arm 234, the sliding button interface 330, and the rear cap 320 are formed as a single component, as shown in Figure 22. In this example, the slider arm 234, the sliding button interface 330, and the rear cap 320 are integral with each other. Alternatively, in another example, the slider arm 434 and the sliding button interface 430 are integral with each other, as shown in Figure 30. In this example, the rear cap is not movable with the slider arm 434. In this example, the rear cap is configured to prevent the drug container from coming out of the distal end of the cassette body 412. For example, the rear cap is fixedly attached to the distal end of the cassette body 412, and the slider arm 434 is configured to move further distal to the rear cap. Note that the movement of the rear cap as described in the above embodiment can be performed independently by the slider arm 434 in this example.

[0084] In this embodiment, the slider arm 234 includes a proximal arm 234a extending in the direction of the longitudinal axis. The proximal arm 234a has a free end facing the distal end of the cassette body 312. In this embodiment, the cassette body 312 includes a proximal-facing surface 312c. In a preferred example, the proximal-facing surface 312c is the proximal edge of the cassette body 312, as shown in Figure 22. The proximal arm 234a is configured to engage with the proximal-facing surface 312c, as shown in Figure 26, so that if the user accidentally moves the sliding button interfaces 330, 430 before the adapter 311 of the infusion set is operably attached to the drug container 14, the slider arm 234 cannot move distally and the cassette body 312 is attached to the housing 3 of the drug delivery device 1. It should be noted that most of the features of the infusion set 6 are identical to those of the embodiments described above, with the main different features being located on the adapters 311 and 411, and therefore the adapters 311 and 411 will be described in detail here. The adapters 311 and 411 include a body 311a, a connector 311d extending from the wall of the body 311a, a protruding channel 311b, and an internal channel coaxial with the protruding channel, as shown in Figures 23 and 24. The internal channel is configured to be at least partially located within the drug container 14 when the adapters 311 and 411 are operably attached to the drug container 14. In this example, the internal channel includes a molded distal end 311e, as shown in Figure 24. The molded distal end 311e is configured to open the seal of the drug container 14 when the adapter 311 is operably attached to the drug container 14. The adapters 311 and 411 are configured to be operably attached to the drug container 14 via the connector 311d. In one example, the connector is configured to be directly attached to the neck of the drug container. Alternatively, the connector 311d is configured to be attached to the cassette body 312. For example, the connector 311d is a snap-fit ​​arm configured to snap into the groove 312d of the cassette body 312, as shown in Figures 28 and 29.In one example, as shown in Figure 29, the adapter 411 includes a gripping mechanism 411a, for example, a recessed portion, so that the user can easily grasp the adapter and attach it to the cassette body. Similarly,

[0085] As described above, the proximal arm 234a is configured to engage with the proximal surface 312c before the adapter 311 of the infusion set is operably attached to the drug container 14, as shown in Figure 26. When the adapter 311 is attached to the drug container 14, the body 311a of the adapter 311 pushes the proximal arm 234a radially inward, as shown in Figure 27. As a result, the proximal arm 234a is disengaged from the proximal surface 312c of the cassette body 312. Thus, when the cassette body 312 is attached to the housing 3, the rear cap 320 can move distally.

[0086] Furthermore, in another embodiment, the cassette body 312 includes container holders 312a, 312b to prevent the drug container 14 from moving proximal to the cassette body 312. In a preferred example, the container holders 312a, 312b are flexible arms 312a extending from the wall of the cassette body 312. The flexible arms 312a include a radially extending ledge 312b, as shown in Figure 25. In this example, the drug container 14 can be inserted into the cassette body 312 from its proximal end. The ledge 312b is configured to engage with the neck of the drug container 14 once it is inserted into the cassette body 312.

[0087] A drug delivery device (such as an auto-injector) may generally include a variety of other components. These may include, for example, a sensor unit that can recognize drug delivery events, such as when a needle is inserted into a pad attachment, when injection begins, and when the drug delivery operation is completed; a memory unit configured to store data recorded during the drug delivery operation; a connectivity unit configured to transmit the stored data directly to a smart device or network; a processing unit configured to control the entire system and process 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.

[0088] 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.

[0089] Once drug delivery is complete, the sensor recognizes the event and is configured to 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.

[0090] The sensor can be a mechanical switch, a Hall effect sensor, an accelerometer, or a combination thereof.

[0091] A mechanical switch, a Hall effect sensor, or an accelerometer can be used to detect when a needle has been inserted into the injection port.

[0092] Accelerometers can be used to detect drug delivery events.

[0093] Possible wireless communication methods include Bluetooth and cellular networks.

[0094] Bluetooth connectivity requires a smart device to transmit stored data over the network, and in the case of bidirectional connectivity, a pairing action is required between the pad and the smart device before the support pad can be used. However, this is a less expensive alternative and requires less space on the PCB. Unidirectional connectivity does not require pairing.

[0095] Cellular networks eliminate the need for any pairing process, can be used as plug-and-play devices, and require no prior setup, but they are expensive and require a lot of space on the PCB.

[0096] Depending on the product requirements, one of these two technologies can be used.

[0097] Such processing units may include logic circuits or control units, including a microprocessor, microcontroller, programmable digital signal processor, or other programmable device. Each processing circuit may further, 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. 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.

[0098] The drug delivery devices described herein can be used to treat and / or prevent one or more of many different types of diseases. Exemplary diseases 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 types of drugs that may be contained in the drug delivery devices described herein include, but are not limited to, antibodies, proteins, fusion proteins, peptide bodies, polypeptides, PEGylated proteins, protein fragments, protein analogs, protein variants, protein precursors, and / or protein derivatives. Examples of drugs that may be included in the drug delivery devices described herein include, but are not limited to, the following (including non-limiting examples of related 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 (ametopterin) (rheumatoid arthritis), tocilizumab (rheumatoid arthritis), interferol β-1a (multiple sclerosis), sumatriptan (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 (e.g., Crohn's disease and ulcerative colitis)). Pharmaceutical formulations including, but not limited to, any of the drugs described herein, for example, pharmaceutical formulations including 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 preparation containing any of the drugs listed herein (or a pharmaceutically acceptable salt thereof) may contain one or more other active ingredients, or it may contain only one active ingredient.

[0099] 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.

[0100] Several other embodiments of the present invention are defined in the following clauses.

[0101] 1. A drug cassette configured to house a drug container, the drug cassette being attachable to a drug delivery device for delivering a drug to an injection site via an infusion set connected to the drug cassette, the drug cassette extending along its longitudinal axis between its distal and proximal ends, the drug cassette A cassette body adapted to receive a drug container in a cylindrical internal space of the main cassette body, wherein the cassette body has a through hole at its proximal end, and the adapter of the infusion set is connected to the drug container through the through hole, A slider arm extending in the proximal direction, wherein the slider arm is located inside the cassette body, and A drug cassette comprising an actuator movable relative to the cassette body, the actuator being mechanically connected to a slider arm such that the movement of the actuator causes a sliding distal movement of the slider arm relative to the cassette body.

[0102] 2. At least one slider arm is an integral part of the actuator, the drug cassette as described in Clause 1.

[0103] 3. The drug cassette according to Clause 1 or 2, wherein the drug cassette is provided with a rear cap that includes a rear end plate configured to prevent the drug container inside the cassette body from moving out of the distal end of the cassette body.

[0104] 4. The drug cassette according to Clause 3, wherein the rear cap has at least one slider arm extending in the proximal direction, and an actuator is mechanically connected to the rear cap such that the movement of the actuator causes the rear cap to slide distally relative to the cassette body.

[0105] 5. A drug cassette according to Clause 3 or 4, wherein, if subject to Clause 3, the cassette body includes at least one slot (19), the at least one slot having a main extension parallel to the longitudinal axis of the drug cassette, and the rear cap (20, 220) includes at least one radially outward extending projection (26) positioned within at least one slot of the cassette body.

[0106] 6. A drug cassette according to any one of clauses 1 to 5, wherein, if subject to clause 3, at least one slider arm (24) is an integral part of the rear cap (20, 220) extending proximal from the rear end plate of the rear cap (20, 220).

[0107] 7. A drug cassette according to any one of Clauses 1 to 6, wherein the rear cap includes at least one flexible arm (40), the at least one flexible arm extending inclined radially outward to first prevent distal movement of the rear cap relative to the cassette body.

[0108] 8. The drug cassette according to Clause 7, wherein the flexible arm bends radially inward through interaction with the receiving interface (10) of the drug delivery device, thereby releasing the rear cap from the cassette body and making it movable distally to the cassette body.

[0109] 9. The rear cap, including the actuator, is a sliding button interface (30, 330) for the user to slide the rear cap distally, as described in Clause 8.

[0110] 10. A drug cassette according to any one of Clauses 1 to 9, wherein the rear cap includes a proximal surface (42) that abuts against the distal surface of the drug container to prevent the drug container from coming out of the distal end of the cassette body.

[0111] 11. A drug cassette according to any one of clauses 1 to 10, wherein, if subject to clause 3, at least one slot includes a first portion (19a), a second portion (19b), and a constricted portion (19c) between the first portion and the second portion.

[0112] 12. The drug cassette according to Clause 11, wherein the radially outward projection (26) of the rear cap is lockable longitudinally in each of the first and second parts.

[0113] 13. A drug cassette according to any one of clauses 1 to 6, wherein the cassette body includes a through hole (58) for receiving an actuator in the form of a rotatable button (64), the rotatable button includes at least one radial projection (70a, b) reaching at least one slider arm of the rear cap inside the cassette body.

[0114] 14. The drug cassette according to Clause 13, wherein at least one slider arm includes a cam surface (54) against which a radial projection abuts when a rotatable button is rotated, and the interaction between the radial projection of the rotatable button and the cam surface causes distal movement of the rear cap.

[0115] 15. The drug cassette according to Clause 13 or Clause 14, wherein the cassette body includes two grooves (60a, b) on the sleeve (62) of the cassette body surrounding the through hole, and the rotary button includes at least one projection that is releasably engaged with each of the two grooves in two different directions of rotation of the rotary button relative to the through hole.

[0116] 16. The slots are uniformly molded, and the drug cassette is as described in any one of clauses 13-15.

[0117] 17. A drug cassette according to any one of clauses 1 to 16, wherein the cassette body includes a radially inward projection (57) configured to prevent the drug container from coming out of the distal end of the cassette body.

[0118] 18. A drug cassette according to any one of Clauses 1 to 17, wherein the rear end plate includes a longitudinal through-hole (38) for receiving a plunger rod from a drug delivery device.

[0119] 19. A drug cassette according to any one of clauses 1 to 18, wherein the drug cassette can be attached to the proximal end of a drug delivery device by inserting the drug cassette into the proximal receiving interface (10) of the drug delivery device, and subsequent axial rotation of the drug cassette (4, 204) causes the proximal surface (46) of the cassette body to engage with the distal surface (49) of the receiving interface (10), thereby longitudinally locking the drug cassette in the mounting position within the receiving interface (10).

[0120] 20. A drug cassette according to any one of clauses 1 to 19, wherein at least one slider arm (234) includes a proximal arm (234a) extending in the direction of the longitudinal axis, and the infusion set is operably connected to the cassette body (312) after the proximal arm (234a) has engaged with the cassette body (312), thereby preventing distal movement of the rear cap (320) relative to the cassette body (312).

Claims

1. A drug cassette (4, 204, 304) configured to house a drug container (14), wherein the drug cassette is attachable to a drug delivery device (1) for delivering a drug to an injection site via an infusion set (6) connected to the drug cassette (4, 204, 304, 404), the drug cassette extends along a longitudinal axis (102) between a distal end (4b) and a proximal end (4a), and the drug cassette is, A cassette body (12, 212, 312, 412) is fitted to receive the drug container in the cylindrical internal space of the cassette main body, wherein the cassette body has a through hole (18) at its proximal end, and the adapter of the infusion set is connected to the drug container through the through hole (18), At least one slider arm (24, 234, 434) extending in the proximal direction, wherein at least one of the slider arms is located inside the cassette body, A drug cassette (4, 204, 304) comprising actuators (28, 30, 64, 330, 430) that are movable relative to the cassette body, wherein the actuators are mechanically connected to the slider arm such that the movement of the actuators causes the slider arm to slide distally relative to the cassette body.

2. The drug cassette according to claim 1, wherein at least one of the slider arms (234, 434) is an integral part of the actuator.

3. The drug cassette according to claim 1 or 2, wherein the drug cassette includes a rear cap at its distal end that includes a rear end plate configured to prevent the drug container inside the cassette body from moving out of the distal end of the cassette body.

4. The drug cassette according to claim 3, wherein the cassette body includes at least one slot (19), the at least one slot having a main extension parallel to the longitudinal axis of the drug cassette, and the rear cap (20, 220) includes at least one radially outward-extending projection (26) positioned within the at least one slot of the cassette body.

5. The drug cassette according to claim 4, wherein, when dependent on claim 3, at least one of the slider arms (24) is an integral portion of the rear cap (20, 220) extending proximal from the rear end plate of the rear cap (20, 220).

6. A drug cassette according to any one of claims 1 to 5, wherein, as applicable to claim 3, the rear cap includes at least one flexible arm (40), the at least one flexible arm extending inclined radially outward to first prevent distal movement of the rear cap relative to the cassette body.

7. The drug cassette according to claim 6, wherein the flexible arm bends radially inward through interaction with the receiving interface (10) of the drug delivery device, thereby freeing the rear cap from the cassette body and making it movable distal to the cassette body.

8. The drug cassette according to claim 7, wherein the rear cap, including the actuator, is a sliding button interface (30, 330, 430) for the user to slide the rear cap in the distal direction.

9. The drug cassette according to any one of claims 1 to 8, wherein the at least one slot includes a first portion (19a), a second portion (19b), and a constricted portion (19c) between the first portion and the second portion.

10. The drug cassette according to claim 9, wherein, as applicable to claim 3, the radially outward-extending projection (26) of the rear cap is lockable longitudinally in each of the first and second portions.

11. A drug cassette according to any one of claims 1 to 10, wherein the drug cassette can be attached to the proximal end of the drug delivery device by inserting the drug cassette into the proximal receiving interface (10) of the drug delivery device, and subsequent axial rotation of the drug cassette (4, 204) causes the proximal surface (46) of the cassette body to engage with the distal surface (49) of the receiving interface (10), thereby enabling the drug cassette to be longitudinally locked in the mounting position within the receiving interface (10).

12. The drug cassette according to any one of claims 1 to 11, wherein the at least one slider arm (234) includes a proximal arm (234a) extending in the direction of the longitudinal axis, and after the proximal arm (234a) engages with the cassette body (312), the infusion set is operably connected to the cassette body (312) and distal movement of the rear cap (320) relative to the cassette body (312) is prevented.

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