Drug delivery devices and drug delivery assemblies

Abstract

This specification relates to a drug delivery device for housing a drug container. The drug delivery device comprises a base unit having a housing extending along a mesio-distal axis, and a drive unit disposed to be subjected to a release motion relative to the base unit in the proximal direction and acting on the drug container to release the drug. The drug delivery device further comprises a signal member (60), which extends longitudinally and interacts with the drive unit and the base unit to be displaced distally upon completion of the release motion, thereby generating an acknowledgment signal. One of the signal member (60) and the drive unit comprises a feedback structure extending along an axial direction and comprising a plurality of recesses and / or protrusions (66). The other of the signal member and the drive unit comprises an engagement structure for interacting with the feedback structure. The release motion causes the engagement structure to slide along the feedback structure, thereby sequentially engaging with the plurality of recesses and / or protrusions (66) to generate a series of feedback signals.

Description

Technical Field

[0001] The present invention is in the field of drug delivery devices. More specifically, the present invention relates to an automated drug delivery device that provides audible, tactile, and / or haptic feedback to a patient using the drug delivery device. The present invention further relates to an assembly comprising such a device, pre-assembled with a drug container.

Background Art

[0002] Drug delivery devices for the automated delivery of drugs by self-administration are well known. In particular, a drug delivery device may be equipped to accommodate a drug container, such as a drug container having a septum that is pierced immediately prior to use, or a syringe. Often, the drug delivery device and the drug container are pre-assembled to form a drug delivery assembly for self-administration.

[0003] Such drug delivery devices and drug delivery assemblies should generally be safe to use and easy to handle, and should reliably deliver a predetermined dose of the drug. From this perspective, it can be important for a patient to receive a feedback signal during and / or after delivery of the drug.

[0004] WO 2011 / 123024 discloses a drug delivery device for a syringe as a drug container, the drug delivery device providing audible, tactile, or visual confirmation to the patient while an injection is being made. For this purpose, the drug delivery device comprises a signal generating member that is an elongate U-bracket. The U-bracket is displaceable distally as soon as a plunger rod that displaces the plunger of the syringe reaches an end position. A drive spring that displaces the plunger rod during delivery then acts on the U-bracket to move it distally until it strikes the inner surface of the housing, resulting in the desired confirmation signal.

[0005] U.S. Patent No. 7,758,550 and International Publication No. 2017 / 129337 disclose a drug delivery device in which a plunger rod is biased distally by a biasing member to deliver a drug. This distal movement of the plunger rod causes a latch element or bump to interact with a coupling structure that moves axially relative, thereby generating a separate acoustic / audible "click" signal during drug delivery.

[0006] Both acoustic feedback during drug delivery and an acoustic confirmation signal after drug delivery is complete have their own advantages. The former indicates to the patient that the device is working and that delivery is in progress. However, patients may not be certain whether delivery is complete when they can no longer hear (or perceive) the signal. The confirmation signal after completion addresses this, but there is no feedback during delivery. [Overview of the Initiative]

[0007] For the reasons stated above, it is desirable to combine both signal generation during delivery and signal generation after delivery. Therefore, an object of the present invention is to provide a drug delivery device that solves at least some of the shortcomings of the prior art and combines signal generation during delivery and signal generation after delivery in a single drug delivery device. A further object is to provide a drug delivery device that does not require many additional parts and structures compared to conventional devices and is economical to manufacture and assemble.

[0008] These and other objectives are achieved by the present invention as defined in the appended claims, which are to be referenced herein.

[0009] In this disclosure, when the term "distal direction" is used, it refers to the direction away from the dose delivery site during use of the drug delivery device. When the term "distal part / end" is used, it refers to the part / end of the delivery device or its component that is 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 toward the dose delivery site during use of the drug delivery device. When the term "proximal part / end" is used, it refers to the part / end of the delivery device or its component that is closest to the dose delivery site during use of the drug delivery device.

[0010] Furthermore, the terms “longitudinal,” “longitudinally,” “axially,” and “axial” refer to the direction extending along the device or its components from the proximal end to the distal end, typically the direction of the longest extension of the device and / or components.

[0011] Similarly, the terms "transverse," "transversal," and "transversally" refer to a direction that is generally perpendicular to the longitudinal direction.

[0012] When it is stated that a component moves proximal, distal, axially in the proximal direction, axially in the distal direction, circumferentially, or in equivalent terms, it refers to movement relative to the housing of the injection device unless otherwise specified.

[0013] According to one aspect of the present invention, a drug delivery device for housing a drug container is provided. The drug delivery device comprises a base unit having a housing extending along a mesiodistal axis, and a drive unit disposed to be subjected to a release motion relative to the base unit in the proximal direction and acting on the drug container to release the drug from the base unit. If the drug container has a plunger or stopper, the drive unit may act on the plunger or stopper, for example by being moved in the proximal direction, to release the drug via a needle, which may belong to the drug delivery device, or, for example, if the drug container is a syringe, may belong to the drug container.

[0014] The drug delivery device further comprises a signaling member, which extends longitudinally and interacts with the drive unit and the base unit to be displaced distally upon completion of the release motion, thereby generating an acknowledgment signal at the time the release motion is completed.

[0015] One of the signal member and the drive unit comprises a feedback structure. The feedback structure comprises a plurality of (in particular, spatially continuous and axially extending) recesses and / or protrusions extending along the axial direction. The other of the signal member and the drive unit comprises an engagement structure for interacting with the feedback structure. The release motion causes the engagement structure to slide along the feedback structure, thereby sequentially engaging with the plurality of recesses and / or protrusions to generate a series of feedback signals.

[0016] Therefore, in the method according to the present invention, the signaling member generates both a series of feedback signals during the release motion (and thus during drug delivery) and a subsequent confirmation signal. In this way, the method combines the advantages of two prior art methods without requiring additional elements or other components.

[0017] In the embodiment, the signal member may have a distal base and a plurality of arms extending proximally from there. In particular, the signal member may have an overall U-shape (bracket shape), with a transverse bridge portion positioned distally as the distal base and two arms extending proximally from there. In this case, a biasing member (e.g., a drive spring) may act between the transverse bridge portion and the drive unit to bias the drive unit so that it is subjected to a release motion when released. Once the release motion is complete, the signal member is able to move distally relative to the base unit, so that the biasing member pushes the signal member distally and causes it to strike the distal end wall of the base unit, thereby generating an acknowledgment signal.

[0018] Specifically, the signaling components and their operating principles may be of the type described in International Publication No. 2011 / 123024.

[0019] The drive unit may include a plunger rod equipped to act on a plunger or stopper of a drug container to release the drug therefrom. In particular, the plunger rod may be the component of the engagement structure (if the signal member has a feedback structure) or the feedback structure (if the signal member has an engagement structure).

[0020] In its initial state (before release), the signaling member may extend along at least a substantial portion of the axial extension of the plunger rod. For example, if the signaling member has multiple arms extending from the distal base, the plunger rod may, in its initial state, be at least partially housed between the arms. Thus, the arms extend along different sides of the plunger rod (e.g., both sides if there are two arms).

[0021] In this case, the projection of the feedback structure may be an inwardly facing signal member projection. Then, the coupling structure of the plunger rod that generates a series of signals together with the feedback structure may be formed by an outwardly facing signal member projection, or, for example, by a shoulder portion, or its distal or proximal end.

[0022] Alternatively, the plunger rod may include a feedback structure in the form of a spatially continuous projection and / or recess along its axial extension. The engagement structure may then include, for example, at least one inwardly facing projection near the proximal end of the arm of the signaling member.

[0023] Both the signaling member and the drive unit (e.g., a plunger rod) can have spatially continuous projections and / or recesses extending in the axial direction, thereby allowing both structures to act simultaneously as a feedback structure and an engagement structure.

[0024] In this embodiment, the base unit comprises a tubular portion having a cavity that opens proximally, and the signal member and the drive unit are at least partially housed within the cavity in the initial state before the release motion.

[0025] Such a tubular portion may, for example, belong to the distal end cap member of the base unit, and the distal end cap member has a distal end wall.

[0026] In its initial position, the signal member may be in a state where there is a gap between its distal base (e.g., transverse bridge) and the distal bottom of the cavity. The signal member may have outwardly projecting support portions (e.g., one per arm) to prevent the signal member from being pushed further into the cavity by the biasing member. For example, the support portion may be positioned immediately proximal to the opening of the cavity and abut against the proximal end of the tubular portion.

[0027] The confirmation signal can be initiated by the plunger rod exiting the space between the arms of the signal member, i.e., the distal end portion of the plunger rod passing beyond the proximal end of the signal member. In particular, the arms can be biased radially inwardly and pressed against the surface of the plunger rod. The arms become capable of flexing radially inwardly as soon as the plunger rod exits the space between the arms of the signal member. As a result, the outwardly projecting support portion is disengaged from engagement with the opening of the tubular portion, whereby the signal member can be further pushed distally into the cavity against the resistance of the drug container by a biasing member that biases the drive unit proximally. Thereby, the gap is closed and the drive unit hits the bottom of the cavity, thereby generating the confirmation signal.

[0028] A distal end cap member of the type described can form part of the housing of the drug delivery device, for example, together with a housing sleeve (and thus the tubular element of the housing). The housing can comprise, in addition to the housing sleeve and / or the distal end cap member, a container housing that is housed within the sleeve and provides a seat for the drug container.

[0029] Its initial activation by releasing the drive unit can be automatic, as is known from the prior art. For example, the drug delivery device can comprise a needle guard that protects the needle (of the drug delivery device or the needle of the drug container for injecting the drug subcutaneously into the patient) after the proximal end cap or the like has been removed immediately before use. The automatic release can occur when the patient presses the drug delivery assembly against the dose delivery site and the needle guard is displaced distally against the biasing force. For this purpose, the drug delivery device can comprise a drive lock member that prevents the drive unit from moving proximally before release. The release can be caused, for example, by the rotation of the drive lock member, such rotation being caused by the needle guard being displaced distally.

[0030] In addition to relating to a drug delivery device, the present invention also relates to a drug delivery assembly comprising a drug delivery device of the kind described herein, the drug delivery assembly being pre-assembled together with a drug container, for example a drug container having a septum that is pierced by the needle of the drug delivery device prior to use, or together with a syringe having a pre-assembled needle.

[0031] In general, all terms used in the claims should be construed according to their ordinary meaning in the technical field, unless explicitly defined otherwise herein. All references to elements, devices, members, components, means, etc. should be construed openly as referring to at least one instance of the element, device, member, component, means, etc., unless explicitly described otherwise.

Brief Description of the Drawings

[0032] Here, embodiments of the present disclosure will be described by way of example only, with reference to the following accompanying drawings. [Figure 1] A diagram of one embodiment of a drug delivery assembly comprising a drug delivery device and a drug container. [Figure 2] The housing sleeve of the drug delivery device. [Figure 3] The needle guard of the drug delivery device. [Figure 4] The drug delivery assembly of FIG. 1 with the proximal end cap and needle cap assembly removed, shown with the housing sleeve and needle guard absent and the drug container and container housing transparent. [Figure 5] A sub-assembly of the drug delivery assembly, the sub-assembly comprising a plunger rod, a signal member, and a drive spring that is a biasing member. [Figure 6] The sub-assembly of FIG. 5 without the plunger rod. [Figure 7] The distal end cap member of the drug delivery assembly. [Figure 8]Figure 5 shows the subassembly assembled with the distal end cap member in a longitudinal cross-section. [Modes for carrying out the invention]

[0033] The drug delivery assembly 1 shown in Figure 1 comprises a drug delivery device and a drug container 3. The drug delivery device comprises a base unit having a housing, the housing comprising a housing sleeve 2 and a distal end cap member 5. The proximal end cap 4, together with a needle cap assembly which optionally has at least one needle cap, protects the needle of the drug delivery assembly during transport and (short-term) storage.

[0034] Before use, the proximal end cap 4 and needle cap assembly are removed.

[0035] Figure 2 shows the housing sleeve 2. The housing sleeve has a housing window 11 that allows the patient to see the drug container 3 to check its contents.

[0036] Figure 3 illustrates the so-called needle guard 10 (or "needle shield" or "needle cover"). Figure 4 shows the drug delivery assembly from Figure 1 with the proximal end cap and needle cap assembly removed, and without the housing sleeve 2 and needle guard 10.

[0037] Therefore, the assembly shown in Figure 4, together with the needle guard 10 and housing sleeve 2, constitutes the drug delivery assembly immediately before use.

[0038] In the depicted embodiment, the base unit of the drug delivery device also includes a container housing 6 for housing a drug container, in addition to the housing sleeve 2 and the distal end cap member 5. The container housing is, for example, transparent or has a window so that the patient can inspect the drug through the housing window 11. The container housing 3 in the depicted embodiment is a syringe equipped with a needle 23. Alternatively, the drug container may be a container equipped with a diaphragm that is punctured by a needle belonging to the drug delivery device before use.

[0039] The drug delivery device further comprises a drive locking member 26 (sometimes called a "rotor") and a plunger rod, along with further elements described in more detail below. The plunger rod, together with further components that move with it where applicable, forms a drive unit.

[0040] As is known in the art, after the proximal end cap and needle cap assembly are removed, the needle guard 10 is pushed by the needle guard spring 13 into a proximal position that protects the needle 23 of the drug delivery assembly.

[0041] To activate the system, the patient presses the drug delivery assembly shown in Figures 2-4, with the proximal end cap and, if applicable, the needle cap assembly removed, against the dose delivery site, thereby displacing the needle guard 10 distally to the housing against the spring force of the needle guard spring 13. As a result, the needle 23 is exposed and can penetrate the patient's skin at the dose delivery site. Simultaneously, the needle guard 10 interacts with the drive lock member 26, causing the drive lock member to rotate by a specific angle around the mesodistal axis 20 (see Figures 1 and 5). This movement releases the drive lock member 26 from the drive unit, allowing it to move proximal axially (release motion), thereby causing the plunger rod to act on the stopper 31 (or plunger) of the drug container. This activates drug delivery.

[0042] Several possible mechanisms exist in which the movement of an activation member (such as the needle guard 10) relative to the housing can activate drug delivery. The present invention does not depend on the nature of this activation and is therefore not described in further detail herein.

[0043] Figures 5 to 8 illustrate how signals are generated during and after drug delivery initiated by the drive unit.

[0044] Figure 5 shows the plunger rod 41 together with the biasing member (drive spring 43 in this specification) and the signaling member 60. Figure 6 shows the elements of Figure 5 without the plunger rod 41. Figure 7 shows the distal end cap member 5, and Figure 8 shows a cross-sectional view of the elements of Figure 5 and the distal end cap member when assembled together.

[0045] The plunger rod 41 has the shape of a sleeve that is at least partially closed towards the proximal end by a proximal end bottom 45 that is pressed against the stopper 31 of the drug container during the release motion. The drive spring 43 extends inside the plunger rod 41 around the shaft of the spring guide 42, with its proximal end in contact with the proximal end bottom 45.

[0046] The signal member 60 has the shape of a U-bracket, from which a distal transverse bridge 61 and two arms 62 extend proximally. At the proximal ends of the arms 62, there are flange-shaped support portions 63 that extend radially outward. As can be seen best in Figure 6, the signal member has a plurality of inwardly projecting signal member protrusions 66 along its arms 62. The signal member protrusions 66 may be arranged at regular intervals, or the distances between the signal member protrusions may vary.

[0047] The distal end cap member 5 has a head portion 52 with a distal end wall 51. A tubular portion 53 having a cavity 54 that opens proximally extends distally within the head portion 52, thereby separating the cavity 54 distally by the distal end wall 51 (see Figure 8).

[0048] As can be seen best in Figure 8, the drive spring 43 is in an energy-storing state in the initial configuration before the start of the release motion, that is, the drive spring is under tension by being compressed between the transverse bridge 61 of the signal member 60 and the proximal end bottom 45 of the plunger rod 41. The support portion 63 of the signal member 60 is located proximal to the tubular portion 53 of the distal end cap member, thereby preventing the proximal end face 55 of the tubular portion from being further displaced distally into the cavity 54 by the spring force of the drive spring 43.

[0049] As soon as the drive locking member 26 (and / or other mechanism) ceases to obstruct the proximal movement of the plunger rod 41 due to user activation, the spring force of the drive spring 43 drives the plunger rod 41 proximal, causing a release motion, which acts on the syringe stopper 31 and releases the drug through the needle 23. This proximal movement causes the plunger rod 41 to disengage from the space between the arms 62 of the signaling member 60. During this motion, the distal end portion 46 continuously passes through the signaling member projections 66. Each time the distal end portion 46 disengages from one of the signaling member projections 66, a signal is generated due to the elastic bending of the signaling member 60 and / or the distal end portion 46 of the plunger rod. As a result, a series of acoustic feedback signals are generated during the release motion. It should be noted that the feedback signals can also provide tactile and / or haptic feedback to the user. Therefore, in this embodiment, the distal end portion 46 acts together with a feedback structure formed by spatially continuous signal member projections 66 as a structure for generating a series of signals during emission motion.

[0050] The arm 62 of the signal member 60 is biased radially inward, thereby pressing the arm against the outer surface of the plunger rod 41. As soon as the distal end portion 46 of the plunger rod 41 passes the end portion 62 of the distal arm, the arm 62 becomes capable of bending inward. This disengages the support portion 63 of the arm from the proximal end face 55. This allows the signal member 60 to move distally by the spring force of the drive spring 43, thereby causing the transverse bridge to strike the distal end wall 51 of the distal end cap member 5. This strike against the distal end wall 51 generates an acknowledgment signal after the release motion. The mechanism for generating the acknowledgment signal in this manner is described in more detail in International Publication No. 2011 / 123024.

[0051] Various other embodiments can be envisioned.

[0052] For example, the plunger rod 41 may have a feedback structure instead of a signal member 60, which includes an inwardly facing signal member projection 66. For example, the plunger rod 41 may have a spatially continuous recess and / or projection as the feedback structure. In this case, the signal member has an inwardly facing projection as an engagement structure at only one axial position, for example, near the proximal end of the arm.

[0053] In addition or alternatively, the feedback structure may differ from one having spatially continuous protrusions as illustrated in the drawings. For example, the feedback structure may have spatially continuous recesses, or the signal member (and / or plunger rod) may generally have a wavy structure, thereby the feedback structure having both recesses and protrusions.

[0054] Furthermore, not all elements described herein are necessarily separate parts. For example, the container housing and housing sleeve, and / or the housing sleeve and distal end cap member, may be integrated as a single part. Also, the spring guide may be integrated with the signal member or distal end cap member (and may protrude into the space between the arms 62 through the hole in the transverse bridge 61), or may be omitted or have at least a reduced axial extension, depending on the mechanical stability of the drive spring.

[0055] Furthermore, the biasing member that stores energy for the release motion is not necessarily a drive spring. For example, it could be a gas cartridge or other simple energy storage unit that can move the drive unit to release the drug.

[0056] The drug delivery devices described herein can be used for the treatment and / or prevention of 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 etanercept (rheumatoid arthritis, inflammatory bowel disease (e.g., Crohn's disease and ulcerative colitis)), evolocumab (hypercholesterolemia), exenatide (type 2 diabetes), secukinumab (psoriasis), erenumab (migraine), alirocumab (rheumatoid arthritis), methotrexate (ametopterin) (rheumatoid arthritis), tocilizumab (rheumatoid arthritis), interferon beta-1a (multiple sclerosis), sumatriptan (migraine), adalimumab (rheumatoid arthritis), and dal Examples include, but are not limited to, the related disorders listed in parentheses. Pharmaceutical formulations, including, but not limited to, any of the drugs described herein, such as pharmaceutical formulations comprising the drugs listed herein (or pharmaceutically acceptable salts thereof) and pharmaceutically acceptable carriers, are also intended for use in the drug delivery devices described herein.A pharmaceutical formulation containing any of the drugs listed herein (or pharmaceutically acceptable salts thereof) may contain one or more other active ingredients, or may contain only one active ingredient.

[0057] Various modifications to the embodiments described are possible and will be conceived by those skilled in the art without departing from the present invention as defined by the following claims.

Claims

1. A drug delivery device for housing a drug container (3), the drug delivery device comprising: a base unit having a housing extending along a mesiodistal axis (20); and a drive unit disposed to be subjected to a release motion relative to the base unit in the proximal direction and acting on the drug container (3) to release a drug from the base unit, wherein the drug delivery device further comprises a signal member (60), the signal member (60) extending in the longitudinal direction and interacting with the drive unit and the base unit, and changing distally upon completion of the release motion. A drug delivery device characterized in that it is positioned and configured to generate confirmation signals, one of the signal member and the drive unit comprises a feedback structure, the feedback structure extends along the axial direction and comprises a plurality of recesses and / or protrusions (66), the other of the signal member (60) and the drive unit comprises an engagement structure, and the release motion causes the engagement structure to slide along the feedback structure, thereby sequentially engaging with the plurality of recesses and / or protrusions to generate a series of feedback signals.

2. The drug delivery device according to claim 1, wherein the signal member (60) has an overall U-shape, having two arms (62) extending proximal to the transverse bridge portion (61), and a biasing member that biases the drive unit to be used for the release motion when released is arranged to be compressed between the transverse bridge portion (61) and the drive unit.

3. The drug delivery device according to claim 1 or 2, wherein the drive unit is equipped with a plunger rod (41) that acts on the plunger or stopper (32) of the drug container (3) during the release motion, causing it to move proximal to the drug and release the drug from the drug container (3).

4. The drug delivery device according to claim 3, wherein each of the plunger rods (41) comprises the feedback structure or the engagement structure.

5. The drug delivery device according to claim 4, wherein the signal member (60) in the initial state before the release motion at least partially accommodates the plunger rod (41) by the two arms (62) that extend along both sides of the plunger rod (41) in the transverse direction.

6. The drug delivery device according to claim 5, wherein the projection of the feedback structure comprises a plurality of inwardly facing signal member projections (66) along the arm (62) of the signal member (60).

7. The drug delivery device according to any one of claims 1 to 6, wherein the base unit comprises a tubular portion (53) having a cavity (54) that opens proximally, and the signal member (60) and the drive unit are at least partially housed in the cavity (54) in the initial state before the release motion.

8. The signal member (60) comprises the transverse bridge (61) and the arm (62) extending proximal therefrom, and the signal member (60) further comprises a support portion (63) projecting radially outward from the arm (62), the support portion preventing the signal member (60) from being displaced further distally into the cavity (54), and the drive unit has, in the initial state, the plunger rod (41) at least partially housed between the arm (62), As soon as the plunger rod is moved to a position proximal to the arm (62) by the release motion, the arm (62) becomes capable of bending radially inward, and the support portion (63) ceases to prevent the signal member (60) from being displaced distally, thereby the biasing member further biases the signal member (60) into the cavity (54) until it strikes the distal end of the cavity (54), thereby generating the confirmation signal, the drug delivery device according to claim 7.

9. The drug delivery device according to claim 8 or 9, wherein the base unit comprises a distal end cap member (5), the distal end cap member (5) comprises a distal end wall (51) of the drug delivery device, and the distal end cap member (5) further comprises the tubular portion (53) having the cavity (54).

10. A drug delivery assembly (1) comprising a drug delivery device according to any one of claims 1 to 9, and further comprising a drug container (3) assembled together with the drug delivery device.

Images