Drug Delivery Devices
The medication delivery device addresses the lack of feedback in existing systems by incorporating a click ring and tubular rotor mechanism for precise and user-friendly drug delivery operations.
Patent Information
- Application Number
- JP2025542167
- Authority / Receiving Office
- JP · JP
- Patent Type
- Applications
- Current Assignee / Owner
- Priority Date
- 2023-07-17
- Filing Date
- 2024-01-30
- Publication Date
- 2026-01-20
AI Technical Summary
Existing drug delivery devices lack effective feedback mechanisms to indicate the progress of medication delivery operations, potentially complicating self-administration by patients without formal medical training.
A medication delivery device with a click ring and tubular rotor mechanism that provides audible and tactile feedback through interacting members, allowing for precise control and indication of drug release progress.
Enhances user experience by providing clear feedback during medication delivery, simplifying self-administration and reducing potential complications.
Smart Images

Figure 2026502012000001_ABST
Abstract
Description
[Technical Field]
[0001] The present invention relates to medication delivery devices, and more particularly to medication delivery devices with automated functionality. [Background technology]
[0002] It is known that drug delivery devices, such as autoinjectors, inhalers, or on-body devices, are generally intended for self-administration of medication by patients without formal medical training. For example, patients suffering from diabetes or those undergoing artificial insemination procedures may require repeated injections of insulin or hormones. Other patients may require regular injections of other types of medication, such as growth hormones. Therefore, drug delivery devices for self-administration typically include multiple automatic functions and protective features. For example, drug delivery member guards are commonly used. The drug delivery member guard is configured to cover the drug delivery member, e.g., the injection needle, to prevent a user from accidentally coming into contact with the drug delivery member.
[0003] The drug delivery member guard is typically arranged to be telescopically movable relative to the housing of the drug delivery device. The drug delivery member guard is configured to come into contact with a drug delivery site. Drug delivery devices that are configured to be triggered by movement of the drug delivery member guard, for example, to insert an injection needle into the drug delivery site and / or to release a contained drug into the drug delivery site, are preferred solutions on the market, for example, when the drug delivery member guard is fully pressed against the drug delivery site, or when the drug delivery member guard is fully pressed against the drug delivery site and a button is manually pressed by a user. However, there is still room for improvement in such designs. Summary of the Invention
[0004] The invention is defined by the appended claims, to which reference should be made below.
[0005] In the present 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 portion / end of the delivery device, or a portion / end of a member thereof, that is located furthest 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 portion / proximal end" is used, it refers to the portion / end of the delivery device, or a portion / end of a member thereof, that is located closest to the dose delivery site during use of the drug delivery device.
[0006] Additionally, the terms "longitudinal," "longitudinally," "axially," or "axial" refer to a direction extending from the proximal end to the distal end, typically along the device or its components, in the direction of the longest extension of the device and / or components.
[0007] Similarly, the terms "transverse," "transversal," and "transversally" refer to a direction generally perpendicular to the longitudinal direction.
[0008] Additionally, the terms "circumference," "circumferential," or "circumferentially" refer to the circumference or direction of circumference relative to an axis, typically a central axis extending in the direction of greatest extension of the device and / or component. Similarly, "radial" or "radially" refers to a direction extending radially relative to an axis, and "rotation," "rotational," and "rotationally" refer to rotation relative to an axis.
[0009] Thus, a drug delivery device is provided, which includes a housing having a proximal end and a distal end, a drug container disposed within the housing, a plunger rod movably disposed within the housing, the plunger rod configured to move into the drug container so that the drug contained therein can be released, the plunger rod including an interacting member, and a click ring disposed at the distal end of the drug container, the mating interacting member of the click ring configured to interact with the interacting member of the plunger rod when the plunger rod is moved relative to the click ring, thereby generating audible / tactile feedback to indicate the progress of drug release, and the click ring configured to make a rattling sound on the drug container when the mating interacting member of the click ring interacts with the interacting member of the plunger rod.
[0010] According to one embodiment, the interacting members of the plunger rod are ratchet teeth extending in the direction of the longitudinal axis.
[0011] According to one embodiment, the interacting members of the plunger rod are ratchet teeth extending in the direction of the longitudinal axis.
[0012] According to one embodiment, the counter interacting member of the click ring is a flexible arm.
[0013] According to one embodiment, the medication delivery device includes a reservoir carrier.
[0014] According to one embodiment, the medication container is secured within a container carrier.
[0015] According to one embodiment, the click ring is attached to the distal end of the container carrier.
[0016] According to one embodiment, the click ring is loosely attached to the distal end of the container carrier.
[0017] According to one embodiment, the click ring includes a proximally oriented hook configured to engage a recess / notch in the container carrier so that the click ring is attached to the container carrier.
[0018] According to one embodiment, the hook is movable within the recess / notch.
[0019] According to one embodiment, the delivery member cover is disposed within the housing and is movable relative to the housing, and the tubular rotator is releasably engaged with the plunger rod.
[0020] According to one embodiment, the tubular rotator is configured to be engaged with the delivery member cover and rotated by the delivery member cover to release the plunger rod.
[0021] According to one embodiment, the tubular rotor includes a tubular body having at least one retaining member on an inner surface thereof configured to releasably engage the plunger rod.
[0022] According to one embodiment, the tubular rotor includes a tubular body having at least one retaining member on an inner surface thereof.
[0023] According to one embodiment, the tubular rotor includes a tubular body having first and second retaining members on an inner surface thereof.
[0024] According to one embodiment, the biased plunger rod includes a mating retaining element configured to interact with at least one retaining member or selectively interact with each of the first, second, and third retaining members.
[0025] According to one embodiment, the tubular rotating body includes a tubular body having a retaining member on an inner surface, and the actuated plunger rod includes first and second mating retaining elements, the first and second mating retaining elements being configured to selectively interact with the retaining member.
[0026] According to one embodiment, the tubular rotating body includes a tubular body having first, second, and third retaining members on its inner surface, and the biased plunger rod includes a mating retaining element configured to selectively interact with each of the first, second, and third retaining members.
[0027] According to one embodiment, the retaining members are radially inwardly projecting ribs.
[0028] According to one embodiment, the first and second retaining members are protrusions.
[0029] According to one embodiment, the counter retaining member is an arm that projects radially outward.
[0030] According to one embodiment, the first and second mating retaining members are grooves.
[0031] According to one embodiment, the medication delivery device further comprises a medication container configured to receive the medication container.
[0032] According to one embodiment, the medication container is axially fixed to the container carrier.
[0033] According to one embodiment, the container carrier includes a dose stop disposed at its distal end.
[0034] According to one embodiment, the biased plunger rod further includes an interaction member configured to interact with a mating interaction member on the distal end of the container carrier.
[0035] According to one embodiment, the interaction between the interacting member and the counter-interacting member is configured to provide feedback to a user of the medication delivery device.
[0036] According to one embodiment, the biased delivery member cover includes a guide element and the tubular rotor includes a tubular body having a guide path disposed on its outer surface, the guide element being configured to interact with the guide path such that axial movement of the biased delivery member cover rotates the tubular rotor.
[0037] According to one embodiment, the biased delivery member cover includes a delivery member cover link, and the guide element is disposed on the delivery member cover link.
[0038] According to one embodiment, the drug delivery device is in an initial state when the rotating body is in a first rotational position defined when the actuated plunger rod is in an initial position in which the mating retaining element is engaged with the first retaining member, when the actuated delivery member cover is in a first retracted position in which the guide element is positioned at a first distal end point of the guide path, and when the actuated delivery member cover is held in that position by a cap assembly releasably connected to the housing.
[0039] According to one embodiment, the medication delivery device is in an initial state when the rotating body is in a first rotational position defined when the actuated plunger rod is in an initial position in which the mating retaining element is engaged with the first retaining member, when the actuated delivery member cover is in a first retracted position in which the guide element is positioned at a first distal end point of the guide path, and when the actuated delivery member cover is held in that position by a knob assembly axially fixedly connected to the distal end of the housing.
[0040] According to one embodiment, the medication delivery device is in a pre-actuated state when the rotating body is in a second rotational position defined when the actuated plunger rod is in a pre-actuated position in which the mating retaining element is engaged with the second retaining member, and when the actuated delivery member cover is in a first extended position in which the guide element is positioned at a first proximal end point of the guide path after the cap assembly is removed from the housing.
[0041] According to one embodiment, the medication delivery device is in a pre-actuated state when the rotating body is in a second rotational position defined when the actuated plunger rod is in a pre-actuated position in which the mating retaining element is engaged with the second retaining member, and when the actuated delivery member cover is in a first extended position in which the guide element is positioned at a first proximal end point of the guide path after the knob assembly is rotated from the first knob position to the second knob position.
[0042] It should be noted that the initial state of the medication delivery device is the state in which the medication delivery device is stored and delivered to an end user, such as a patient, a caregiver, and / or a pharmacy, and the pre-actuation state is the state in which the end user has the medication delivery device ready for use but has not yet performed a medication delivery operation, e.g., delivery of a medication to a target delivery site. The pre-actuation state can be defined, for example, as a priming state in which the movement of the plunger rod is configured to release gas in the medication container, and / or as a mixing state in which the movement of the plunger rod is configured to mix multiple substances in multiple chambers, respectively, and / or as a calibration state in which the movement of the plunger rod moves itself to a "zero dose" position defined between the end of the dose stop of the plunger rod and the zero dose position of the plunger rod so that the medication can be delivered to the target delivery site.
[0043] According to one embodiment, the actuated plunger rod is configured to move from a pre-actuation position to a final position in which the mating retaining element is engaged with the third retaining member when the actuated delivery member cover is moved from a first extended position to a second retracted position in which the guide element is positioned at a second distal end point of the guide path so that the drug contained in the drug container is delivered to a user of the drug delivery device.
[0044] It should be noted that the pre-actuation state is optional, i.e., the second retaining member of the rotor is optional. In one example where the rotor does not have a second retaining member, the plunger rod is configured to engage with the first retaining member of the rotor until the medication delivery device is triggered, and in this example, the plunger rod is configured to move from an initial position to a final position where the mating retaining element engages with the third retaining member of the rotor.
[0045] According to one embodiment, the biased delivery member cover is axially movable from a first retracted position to a first extended position, and from the first extended position to a second retracted position, and from the second retracted position to a second extended position in which the guide element is positioned at a second proximal end point of the guide path, such that the delivery member extends from the delivery member cover when the delivery member cover is in the first and second retracted positions and is covered by the delivery member cover when the delivery member cover is in the first and second extended positions.
[0046] According to one embodiment, the mating retaining element is configured to disengage from the second retaining member when the biased delivery member cover is axially movable from the first extended position to the second retracted position such that the rotor is moved from the second rotational position to the third rotational position.
[0047] According to one embodiment, the tubular rotor includes an inclined surface disposed between the first and second retaining members, and the mating retaining element is configured to move along the inclined surface from the first retaining member to the second retaining member.
[0048] According to one embodiment, axial movement of the biased delivery member cover from the first retracted position to the first extended position rotates the tubular rotor from the first rotational position to the second rotational position.
[0049] According to one embodiment, the medication delivery device includes a resilient member configured to proximally bias the biased delivery cover member.
[0050] According to one embodiment, the click ring is positioned along the longitudinal axis between the tubular rotor and the medication container.
[0051] According to one embodiment, the click ring is positioned along the longitudinal axis between the tubular rotor and the container carrier.
[0052] According to one embodiment, the delivery member cover includes a guide element and the tubular rotor includes a tubular body having a guide channel disposed on an outer surface thereof.
[0053] According to one embodiment, the guide element is configured to interact with the guide path such that axial movement of the biased delivery member cover rotates the tubular rotor such that the plunger rod is released from the tubular rotor.
[0054] According to one embodiment, the drug delivery device may be an injection device, an on-body device, an inhalation device, a nasal spray, or a medical sprayer.
[0055] According to one embodiment, the delivery member may be a syringe needle, a catheter, or a spray nozzle.
[0056] Other aspects, features, and advantages will become apparent from the above summary and from the following description, including the drawings and claims.
[0057] 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 broadly as referring to at least one instance of the element, device, component, means, etc., unless expressly stated otherwise. [Brief explanation of the drawings]
[0058] Specific embodiments of the inventive concept will now be described, by way of example only, with reference to the accompanying drawings in which: [Figure 1] 1 shows a drug delivery device of the present invention. [Figure 2] FIG. 2 is an exploded view showing details of the drug delivery device of FIG. 1. [Figure 3] FIG. 2 is a perspective view showing a tubular rotating body. [Figure 4] FIG. 2 is a perspective view showing a plunger rod. [Figure 5] FIG. 10 shows a diagram illustrating the administration stop portion of the present invention. [Figure 6] FIG. 2 illustrates an indicator element of the present invention. [Figure 7] FIG. 7 is a cross-sectional view showing the indication of FIG. 6. [Figure 8] FIG. 10 is a perspective view of another embodiment of an indicator element of the present invention. DETAILED DESCRIPTION OF THE INVENTION
[0059] The present application is directed to a feedback mechanism for a medication delivery device, which will be described in more detail below with reference to the accompanying drawings, in which exemplary embodiments are shown. However, the feedback mechanism 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.
[0060] FIG. 1 illustrates a medication delivery device according to an embodiment of the present invention, having a housing 1 having a proximal end and a distal end along a longitudinal axis L, and a cap assembly 2 disposed at the proximal end of the housing 1 in an initial state of the medication delivery device. As illustrated in FIG. 2, the medication delivery device further includes a delivery member cover 3 that is axially movable relative to the housing 1 but rotationally fixed, a resilient member 31 disposed between the distal end of the delivery member cover 3 and an inner distal protrusion of the housing 1 and configured to urge the delivery member cover 3 proximally relative to the housing 1, and a tubular rotor 4. The tubular rotor 4 includes a tubular body disposed within the housing 1 and is rotatable relative to the housing 1 but axially immovable. The medication delivery device further includes a plunger rod 5 disposed axially movably within the housing 1, a drive element 51 disposed within the plunger rod 5 and configured to urge the plunger rod proximally, and a container carrier 6 disposed within the housing 1. The container carrier 6 is axially and rotationally fixed relative to the housing 1 and configured to receive a medication container 8. The drug container 8 is configured to contain a drug and includes a stopper 81 disposed at its distal end and a pierceable membrane disposed at its proximal end.
[0061] In a preferred example, the drug container is a container 8 configured to be separated from the drug delivery member before use. In this example, the drug delivery member needs to be fluidly connected to the container 8 to deliver the drug, for example, manually by a user or automatically, before drug delivery begins. In this example, the drug delivery device includes a delivery member assembly 7 including a delivery member configured to deliver a dose of drug to an end user during a drug delivery operation. The delivery member assembly further includes a delivery member hub configured to hold the delivery member, an inner cap configured to cover the delivery member, and a retainer configured to threadably engage with the inner cap in an initial state of the drug delivery device. A cap assembly 2 is axially fixed to the inner cap of the delivery member assembly 7 and rotationally fixed with the inner cap in one rotational direction. The retainer is snap-fixed to the container carrier 6 such that the cap assembly 2 is attached to the housing 1 through the delivery member assembly 7 in the initial state of the drug delivery device. The cap assembly 2 can be removed from the housing 1 of the drug delivery device when both the cap assembly 2 and the inner cap are twisted and disengaged from the retainer. Such twisting motion is translated into axial motion of the delivery member hub by the connection between the inner cap and the delivery member hub, whereby the delivery member is moved together with the delivery member hub towards the drug container 8, establishing fluid communication with the drug container 8. Alternatively, the drug container is a syringe with an integral delivery member. In this example, the drug delivery device does not include a delivery member assembly.
[0062] 3 shows a tubular rotor including a first retaining member 43a and a second retaining member 43b disposed on the inner surface of the tubular body. The first and second retaining members are configured to selectively engage with a mating retaining member 52 on the plunger rod 5, as shown in FIG. 4, thereby preventing proximal axial movement of the plunger rod. The mating retaining member 52 is configured to rest on the first retaining member 43a when the tubular rotor 4 is in a first rotational position, and is configured to disengage from the first retaining member 43a, move proximally under the biasing force of the drive element 51, and engage with the second retaining member 43b when the tubular rotor 4 is in a second rotational position.
[0063] In one example, the plunger rod 5 is in its initial position when the mating retaining member 52 is engaged with the first retaining member 43a. When the plunger rod is in its initial position, the medication delivery device is in its initial state where all components of the medication delivery device are assembled together and the device is ready for delivery to an end user.
[0064] When the mating retaining member 52 of the plunger rod 5 is engaged with the second retaining member 43b of the tubular rotating body 4, the plunger rod 5 is in a ready-to-use position, and as a result the drug delivery device is ready to perform the drug delivery operation.
[0065] It should be noted that the drug delivery device can optionally provide a priming function, e.g., releasing air from a drug container, a mixing function, e.g., mixing multiple substances, and / or a calibration function, e.g., fixing the starting position of the plunger rod 5 relative to the housing before performing a drug delivery operation. Alternatively, the drug delivery device can be designed without these functions, in which case the first holding member of the rotator is not necessarily required. Also, the rotator only needs to be rotated once, i.e., the rotator can be rotated from the second rotation position to the third rotation position.
[0066] To perform the drug delivery operation, the mating retaining member 52 of the plunger rod 5 is configured to disengage from the second retaining member 43b of the tubular rotor 4 when the tubular rotor 4 is in the third rotational position, whereby the plunger rod moves proximally under the biasing force of the drive element 51 and acts on the stopper 81 to deliver a dose of drug. This initiates the drug delivery operation. The mating retaining member 52 of the plunger rod 5 is configured to move proximally to engage with the dose stop 61 when the plunger rod 5 is in the final position, whereby the drug delivery operation is terminated. The dose stop 61 may be a protrusion disposed on the distal end of the container carrier 6 as shown in FIG. 5 , or a protrusion disposed on an additional component, or a third retaining member disposed on the inner surface of the tubular rotor 4. The delivered dose is determined by the distance between the second retaining member 43b and the dose stop, which is also the movement distance of the plunger rod 5 from the ready-to-use position to the final position.
[0067] 2 to 4, in a preferred example, the mating holding member 52 of the plunger rod 5 is a protrusion extending from the main body of the plunger rod 5, and the first and second holding members are protrusions extending from the inner surface of the tubular rotating body 4. Alternatively, the mating holding member may be a recess / notch, and the holding member of the tubular rotating body may be a flexible arm.
[0068] The tubular rotor 4 is configured to interact with the delivery member cover 3. In a preferred example, the delivery member cover 3 includes a guide element 32 configured to move along a guide path 41 disposed on the outer surface of the tubular rotor 4. The interaction of the guide element 32 with the guide path 41 causes the tubular rotor 4 to rotate from a first rotational position to a second rotational position, and from the second rotational position to a third rotational position.
[0069] The delivery member cover 3 can be manually pushed distally to its retracted position to trigger a drug delivery operation. When the delivery member cover 3 moves to the retracted position, the guide element 32 is moved along the third inclined protrusion 41g and the operating protrusion 41h toward its second proximal-distal end point of the guide path 41. When the guide element 32 passes the third inclined protrusion 41g of the guide path 41, the tubular rotor 4 is rotated from the second rotation position to the third rotation position, thereby initiating a drug delivery operation.
[0070] After the drug delivery operation is terminated, the delivery member cover 3 is no longer pushed into or held in the second retracted position, and is configured to move proximally to its second extended position under the biasing force of the elastic member 31, so as to again surround the delivery member. The proximal movement of the delivery member cover 3 causes the guide element 32 to move proximally along the operating protrusion 41h of the guide path 41 to its second proximal end point 41i of the guide path 41. Before the guide element 32 moves to the second proximal end point 41i of the guide path 41, the guide element 32 passes through the locking tongue 42 of the tubular rotor 4, whereby the locking tongue 42 includes a proximally directed cliff surface. Therefore, when the guide element 32 moves to the second proximal end point 41i of the guide path 41, a blockage between the guide element 32 and the proximally directed cliff surface of the locking tongue 42 prevents further distal movement of the delivery member cover 3.
[0071] The delivery member protrudes from the proximal end of the delivery member cover 3 when the delivery member cover 3 is in the first and second retracted positions, and is covered by the delivery member cover 3 when the delivery member cover is in the first and second extended positions.
[0072] Axial movement of the delivery member cover 3 driven by the elastic member 31 from the first retracted position to the first extended position moves the guide element 32 from the first distal end point 41c to the proximal end point 41f of the guide path 41. When the guide element 32 passes the first inclined protrusion 41d and the second inclined protrusion 41e, the tubular rotor 4 is gradually rotated from the first rotation position to the second rotation position.
[0073] In one example in which the rotating body includes a first retaining member 43a for initially retaining the plunger rod 5, the rotating body 4 is engaged with the plunger rod 5 through the engagement between the first retaining member 43a and the mating retaining member 52. Therefore, friction occurs between the first retaining member 43a and the mating retaining member 52 when the rotating body 4 rotates relative to the plunger rod 5. The magnitude of the friction depends on the force accumulated in the driving element 51, which acts on the plunger rod 5. Therefore, if the force accumulated in the driving element 51 is too large, the rotating body 4 may not be rotated by the guide element 32 of the delivery member cover 3, which is driven proximally by the elastic member 31. This risk can be overcome by providing an inclined surface connecting the first and second retaining members. Thus, the plunger rod 5 can move along the inclined surface from the first retaining member 43a to the second retaining member 43b. As a result, the rotation of the tubular rotating body 4 from the first rotation position to the second rotation position is mainly subjected to a biasing force from the driving element 51.
[0074] Furthermore, the medication delivery device is configured to provide audible / tactile feedback to a user of the medication delivery device to indicate the progress of the medication delivery operation. The feedback is provided by an interaction member 53, preferably ratchet teeth extending in the direction of the longitudinal axis L, disposed on the plunger rod 5, and a counter-interaction member 92; 92' adjacent to the distal end of the container 8. As the plunger rod 5 moves proximally and passes the distal end of the medication container 8, continuous feedback is generated through the interaction between the interaction member 53 and the counter-interaction member 92; 92'. In a preferred example, the counter-interaction member 92; 92' is a flexible arm having a free end that sequentially engages with each tooth of the ratchet teeth 53 when the interaction member 53 interacts with the counter-interaction member 92; 92'. In a preferred example, the plunger rod 5 includes a longitudinally extending groove 54. In this example, the interaction member 53 is disposed within the groove 54. In one example where the interacting member 53 is a ratchet tooth, the ratchet tooth 53 extends into the groove in the direction of the longitudinal axis L. In one example, as shown in FIG. 8 , the container carrier 6′ includes a protrusion 64′ configured to be positioned in the groove 54 and guide movement of the plunger rod 5, such that the interacting member 53 is aligned with the mating interacting member 92.
[0075] In one example, as shown in Figures 6 and 7, the medication delivery device includes a click ring 9;9'. In one example, the click ring 9;9' is attached to the distal end of the container carrier 6, or alternatively, the click ring is attached to the housing. In one example, the click ring 9;9' includes a proximally extending hook 91, and in this example, the click ring 9;9' is attached to the container carrier 6 by engaging the hook 91 with a recess / notch 63 in the container carrier 6, as shown in Figure 6.
[0076] In one example where the counter-interacting member 92; 92' is a flexible arm, the free end of the flexible arm is directed towards the distal end of the housing as shown in Figure 7, alternatively or additionally, the free end of the flexible arm is directed towards the proximal end of the housing as shown in Figure 8. In the former example, a louder sound indication may be produced, and in the latter example, a continuous indication may last longer.
[0077] As mentioned above, such feedback mechanisms are configured to provide audible / tactile feedback to the user to indicate the progress of the medication delivery operation. However, the feedback is typically provided by the plunger rod. This can add friction to the injection, potentially adversely affecting the injection. Therefore, separating the click portion into a separate click ring from other components, such as the container carrier or housing, allows for greater design flexibility. For example, the click ring can be manufactured from a different material than the housing or container carrier, and thus the material can be selected to reduce friction.
[0078] In a preferred example, the click ring is loosely assembled between the container carrier 6 and the tubular rotor 4. The audible / tactile feedback is generated by the interacting member 53 of the plunger rod 5 and the mating interacting member 92; 92' of the click ring 9; 9', and greater audible feedback can be generated as a result of the interaction between the plunger rod and the click ring causing the click ring to rattle, e.g., vibrate, between the tubular rotor 4 and the container carrier. In a preferred example, as shown in Figures 6 and 8, the click ring 9; 9' is loosely attached to the container carrier 6. In this example, the hook 91 is movable within the recess / notch 63 of the container carrier 6.
[0079] It should be noted that in a preferred embodiment, the click ring 9; 9' is ring-shaped. Alternatively, the click ring is formed in the shape of a circlip or comprises a rectangular cross section seen along the longitudinal axis L.
[0080] Additionally, the housing of the drug delivery device and / or the container carrier of the drug delivery device may be provided with (i.e., molded with, or with) a compound characterized by persistent antibacterial, antifungal, and / or antiviral properties, as described in any of the examples. Alternatively, the compound characterized by persistent antibacterial, antifungal, and / or antiviral properties may be applied to the molded (i.e., finished) component by a secondary process (e.g., chemical vapor deposition), spraying, or dipping process.
[0081] The drug delivery devices described herein can be used to treat and / or prevent one or more of many different types of disorders. Exemplary disorders include, but are not limited to, rheumatoid arthritis, inflammatory bowel disease (e.g., Crohn's disease and ulcerative colitis), hypercholesterolemia, diabetes (e.g., type 2 diabetes), psoriasis, migraines, 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, small molecules, hormones, cytokines, blood products, antibodies, antibody-drug conjugates, bispecific antibodies, proteins, fusion proteins, peptibodies, polypeptides, pegylated proteins, protein fragments, protein analogs, protein variants, protein precursors, chimeric antigen receptor T-cell therapies, cell or gene therapy drugs, oncolytic viruses, or immunotherapeutic drugs and / or protein derivatives.Exemplary drugs that may be included in the drug delivery devices described herein include etanercept (rheumatoid arthritis, inflammatory bowel disease (e.g., Crohn's disease and ulcerative colitis)), evolocumab (hypercholesterolemia), exenatide (type 2 diabetes), secukinumab (psoriasis), erenumab (migraine), alirocumab (rheumatoid arthritis), methotrexate (amethopterin) (rheumatoid arthritis), tocilizumab (rheumatoid arthritis), interferon beta-1a (multiple sclerosis), and steroid hormone receptor agonist (steroid hormone receptor agonist). inflammatory bowel disease), sumatriptan (migraine), adalimumab (rheumatoid arthritis), darbepoetin alfa (anemia), belimumab (lupus), peginterferon 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) Diseases (e.g., Crohn's disease and ulcerative colitis), ipilimumab, nivolumab, pembrolizumab, atezolizumab, durvalumab, avelumab, cemiplimab, rituximab, trastuzumab, ado-trastuzumab emtansine, fam-trastuzumab deruxtecan-nxki, pertuzumab, transtuzumab-pertuzumab, alemtuzumab, belantamab-mafodotin-blmf, bevacizumab, blinatumomab, brentuximab vedotin , cetuximab, daratumumab, elotuzumab, gemtuzumab ozogamicin, 90-yttrium-ibritumomab tiuxetan, isatuximab, mogamulizumab, moxetumomab pasudotox, obinutuzumab, ofatumumab, olaratumumab, panitumumab, polatuzumab vedotin, ramucirumab, sacituzumab govitecan, tafasitamab, or margetuximab (non-limiting examples of associated disorders are in parentheses). 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.
[0082] Exemplary agents that may be included in the drug delivery devices described herein include, but are not limited to, immuno-oncology or bio-oncology agents such as immune checkpoints, cytokines, chemokines, differentiation clusters, interleukins, integrins, growth factors, enzymes, signaling proteins, pro-apoptotic proteins, anti-apoptotic proteins, T cell receptors, B cell receptors, or costimulatory proteins.
[0083] Exemplary agents that may be included in the drug delivery devices described herein include HER-2 receptor modulators, interleukin modulators, interferon modulators, CD38 modulators, CD22 modulators, CCR4 modulators, VEGF modulators, EGFR modulators, CD79b modulators, Trop-2 modulators, CD52 modulators, BCMA modulators, PDGFRA modulators, SLAMF7 modulators, PD-1 / PD-L1 inhibitors / modulators, B lymphocyte antigen CD19 inhibitors, B lymphocyte antigen CD20 modulators, CD3 modulators, CTLA-4 inhibitors, TIM-3 modulators , VISTA modulators, INDO inhibitors, LAG3 (CD223) antagonists, CD276 antigen modulators, CD47 antagonists, CD30 modulators, CD73 modulators, CD66 modulators, CDw137 agonists, CD158 modulators, CD27 modulators, CD58 modulators, CD80 modulators, CD33 modulators, APRIL receptor modulators, HLA antigen modulators, EGFR modulators, B lymphocyte cell adhesion molecule modulators, CDw123 modulators, Erbb2 tyrosine kinase receptor modulators, mesothelin modulators, HAVCR2 antagonists, NY-ESO-1 OX40 receptor agonist modulators, adenosine A2 receptors, ICOS modulators, CD40 modulators, TIL therapy or TCR therapy.
[0084] Exemplary drugs that may be included in the drug delivery devices described herein include AC, high-dose AC, TCH, GT, EC, TAC, TC, TCHP, CMF, FOLFOX, mFOLFOX6, mFOLFOX7, FOLFCIS, CapeOx, FLOT, DCF, FOLFIRI, FOLFIRINOX, FOLFOXIRI, IROX, CHOP, R-CHOP, RCHOP-21, Mini-CHOP, Maxi-CHOP, VR-CAP, high-dose CHOP, EPOCH, dose-adjusted EPOCH, R-EPOCH, CODOX-M, IVAC, HyperCVAD, R-HyperCVAD, SC-EPOCH-RR, DHAP, ESHAP, GDP, ICE, MINE, CEPP, CDOP, GemOx, CEOP, CEPP, CHOEP, CHP, GCVP, DHAX, CALGB These include, but are not limited to, multidrug treatment regimens such as 8811, HIDAC, MOpAD, 7+3, 5+2, 7+4, MEC, CVP, RBAC500, DHA-Cis, DHA-Ca, DHA-Ox, RCVP, RCEPP, RCEOP, CMV, DDMVAC, GemFLP, ITP, VIDE, VDC, VAI, VDC-IE, MAP, PCV, FCR, FR, PCR, HDMP, OFAR, EMA / CO, EMA / EP, EP / EMA, TP / TE, BEP, TIP, VIP, TPEx, ABVD, BEACOPP, AVD, Mini-BEAM, IGEV, C-MOPP, GCD, GEMOX, CAV, DT-PACE, VTD-PACE, DCEP, ATG, VAC, VelP, OFF, GTX, CAV, AD, MAID, AIM, VAC-IE, ADOC, or PE.
[0085] Exemplary drugs that may be included in the drug delivery devices described herein include, but are not limited to, those used in chemotherapy, such as alkylating agents, plant alkaloids, antitumor antibiotics, antimetabolites, or topoisomerase inhibitors, enzymes, retinoids, or corticosteroids. Non-limiting exemplary chemotherapy agents include 5-fluorouracil, cisplatin, carboplatin, oxaliplatin, doxorubicin, daunorubicin, idarubicin, epirubicin, paclitaxel, docetaxel, cyclophosphamide, ifosfamide, azacitidine, decitabine, bendamustine, bleomycin, bortezomib, busulfan, cabazitaxel, carmustine, cladribine, cytarabine, dacarbazine, etoposide, fludarabine, gemcitabine, irinotecan, leucovorin, melphalan, methotrexate, pemetrexed, mitomycin, mitoxantrone, temsirolimus, topotecan, valrubicin, vincristine, vinblastine, or vinorelbine.
[0086] 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.
Claims
1. a housing (1) having a proximal end and a distal end; a drug container (8) disposed within the housing (1); a plunger rod (5) movably disposed within the housing (1), the plunger rod (5) being configured to move into the drug container (8) so that the drug contained therein can be released, the plunger rod (5) including an interaction member (53); a click ring (9) disposed at the distal end of the medication container (8); a counter-interacting member (92) of the click ring (9) configured to interact with the interacting member (53) of the plunger rod (5) when the plunger rod (5) is moved relative to the click ring (9), thereby generating an audible / tactile feedback to indicate the progress of release of the drug; The drug delivery device, wherein the click ring (9) is configured to rattle on the drug container (8) when the counter-interacting member (92) of the click ring (9) interacts with the interacting member (53) of the plunger rod (5).
2. 2. The medication delivery device according to claim 1, wherein the interacting members (53) of the plunger rod (5) are ratchet teeth extending in the direction of the longitudinal axis (L).
3. 3. A medication delivery device according to any one of claims 2, wherein the counter-interacting member (92) of the click ring (9) is a flexible arm.
4. 4. The drug delivery device according to claim 3, wherein the flexible arm includes a free end configured to contact the interaction member of the plunger rod (5), the free end facing towards the proximal end of the housing (1).
5. A medication delivery device according to any one of claims 1 to 4, comprising a container carrier (6), wherein the medication container (8) is fixed in the container carrier (6).
6. 6. The medication delivery device according to claim 5, wherein the click ring (9) is attached to the distal end of the container carrier (6).
7. 7. The medication delivery device according to claim 6, wherein the click ring (9) is loosely attached to the distal end of the container carrier (6).
8. A medication delivery device as described in claim 6 or 7, wherein the click ring (9) includes a proximally directed hook (91) configured to engage with a recess / notch (63) in the container carrier (6) so that the click ring (9) is attached to the container carrier (6).
9. 9. A medication delivery device according to claim 7 or 8, in combination with claim 8, wherein the hook (91) is movable within the recess / notch (63).
10. a delivery member cover (3) disposed within the housing (1) and movable relative to the housing (1); A medication delivery device as described in any one of claims 1 to 9, comprising a tubular rotating body (4) releasably engaged with the plunger rod (5), the tubular rotating body (4) being engaged with the delivery member cover (3) and configured to be rotated by the delivery member cover (3) to release the plunger rod (5).
11. 11. The medication delivery device of claim 10, wherein the tubular rotating body (4) comprises a tubular body having at least one retaining member on its inner surface configured for releasable engagement with the plunger rod (5).
12. 12. Medication delivery device according to claim 10 or 11, wherein the click ring (9) is positioned along the longitudinal axis (L) between the tubular rotating body (4) and the medication container (8).
13. A medication delivery device as described in claim 12 when dependent on any one of claims 5 to 9, wherein the click ring (9) is positioned between the tubular rotating body (4) and the container carrier (6) along the longitudinal axis (L).
14. A drug delivery device as described in any one of claims 10 to 13, wherein the delivery member cover (3) includes a guide element (32), the tubular rotating body (4) includes a tubular body having a guide path (41) arranged on its outer surface, and the guide element (32) is configured to interact with the guide path (41) so that axial movement of the biased delivery member cover (3) rotates the tubular rotating body (4) so that the plunger rod (5) is released from the tubular rotating body (4).
15. A medication delivery device according to any one of claims 10 to 14, comprising a resilient member (31) configured to bias the delivery cover member (3) proximally.
Citation Information
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