The invention concerns sub-assemblies for medicament delivery devices, and particularly sub-assemblies with a housing and a plunger rod.
Some medicament delivery devices provide feedback to their users during operation, such as with the U-bracket described in WO2011/123024. While such systems can provide effective feedback, the applicant has appreciated that an alternative feedback mechanism could usefully be provided, potentially providing various advantages when compared to existing feedback mechanisms.
Reference should now be made to the appended claims.
In the present disclosure, when the term “distal direction” is used, this refers to the direction pointing away from the dose delivery site during use of the medicament delivery device. When the term “distal part/end” is used, this refers to the part/end of the delivery device, or the parts/ends of the members thereof, which during use of the medicament delivery device is/are located furthest away from the dose delivery site. Correspondingly, when the term “proximal direction” is used, this refers to the direction pointing towards the dose delivery site during use of the medicament delivery device. When the term “proximal part/end” is used, this refers to the part/end of the delivery device, or the parts/ends of the members thereof, which during use of the medicament delivery device is/are located closest to the dose delivery site.
Further, the terms “longitudinal”, “longitudinally”, “axially” and “axial” refer to a direction extending from the proximal end to the distal end and along the device or components thereof, typically in the direction of the longest extension of the device and/or component.
Similarly, the terms “transverse”, “transversal” and “transversally” refer to a direction generally perpendicular to the longitudinal direction.
A sub-assembly for a medicament delivery device, the sub-assembly extending along a longitudinal axis in a longitudinal direction from a proximal end to a distal end, the sub-assembly comprising: a housing; and a plunger rod arranged at least partly inside the housing, the plunger rod being rotationally locked relative to the housing; wherein the plunger rod comprises a flexible arm, the flexible arm comprising a first surface facing towards the proximal end; wherein a component of the sub-assembly other than the plunger rod comprises a second surface facing towards the distal end, with the first surface and the second surface being arranged so that, when the plunger rod moves towards the proximal end relative to the component during medicament delivery device use, the first surface and the second surface engage to flex the flexible arm in a circumferential direction relative to the component and then disengage so that the flexible arm flexes back relative to the component (to create feedback). This can provide a feedback such as an audible, visible or tactile feedback to a medicament delivery device user.
Optionally, the component is the housing. Optionally, the housing comprises an outer housing and a rear cap, and the rear cap comprises the second surface. Optionally, the second surface is on a protrusion. Optionally, the protrusion extends towards the longitudinal axis.
Optionally, at least part of at least one of the first surface and the second surface is angled relative to a plane perpendicular to the longitudinal axis.
Optionally, the at least part of at least one of the first surface and the second surface is angled relative to a plane perpendicular to the longitudinal axis at an angle of between 10 and 85 degrees. Optionally, at least part of the first surface is angled relative to a plane perpendicular to the longitudinal axis.
Optionally, the sub-assembly comprises a feedback surface angled relative to a plane perpendicular to the longitudinal axis, wherein the feedback surface is spaced apart in a circumferential direction relative to the longitudinal axis from a distal end of the first surface.
Optionally, at least part of the second surface is angled relative to a plane perpendicular to the longitudinal axis. Optionally, the first surface and/or the second surface comprises a surface (79) that is parallel to the longitudinal axis.
Optionally, the sub-assembly comprises a feedback surface angled relative to a plane perpendicular to the longitudinal axis, wherein the feedback surface is spaced apart in a circumferential direction relative to the longitudinal axis from a proximal end of the first surface.
Optionally, the plunger rod comprises the feedback surface. Optionally, the feedback surface is parallel to the longitudinal axis.
Optionally, the component is rotationally locked relative to the housing (30, 62).
Optionally, a spring is arranged between the plunger rod and the housing, and the spring is configured to move the plunger rod towards the proximal end during medicament delivery.
Optionally, the plunger rod is rotationally locked relative to the housing by a protrusion and a groove arranged in the protrusion, wherein one of the protrusion and the groove is on the plunger rod and the other of the protrusion and the groove are on any component of the sub-assembly other than the plunger rod. Optionally, the any component of the sub-assembly other than the plunger rod is the housing.
Optionally, a distal end of the flexible arm is attached to a main body of the plunger rod, and wherein a proximal end of the flexible arm is free to flex relative to the main body of the plunger rod. Optionally, the flexible arm is in a recess or slot in a main body of the plunger rod.
An aspect concerns a medicament delivery device comprising any sub-assembly as described above. Optionally, the medicament delivery device is an autoinjector.
An aspect concerns a method of creating feedback in a medicament delivery device, the method comprising the following steps in the following order: moving a plunger rod in a proximal direction relative to another component so that a proximally facing surface of a flexible arm of the plunger rod engages a distally facing surface of the another component, thereby rotating the plunger rod in a first direction relative to the another component; moving the plunger rod further in the proximal direction relative to the another component so that the proximally facing surface of the plunger rod disengages the distally facing surface of the another component and subsequently rotates the plunger rod in a second direction, thereby creating feedback. Typically, the first direction and the second direction are opposite directions. Optionally, the another component is a housing.
An aspect concerns a sub-assembly for a medicament delivery device, the sub-assembly extending along a longitudinal axis in a longitudinal direction from a proximal end to a distal end, the sub-assembly comprising: a housing; and a plunger rod arranged at least partly inside the housing; wherein the plunger rod comprises a first engagement portion and a component of the sub-assembly other than the plunger rod comprises a second engagement portion, wherein the first engagement portion and the second engagement portion are arranged so that, when the plunger rod moves relative to the component during medicament delivery device use, the first engagement portion engages the second engagement portion so that a flexible arm of the plunger rod flexes relative to the component and then disengages the second engagement portion so that the flexible arm flexes back relative to the component. Optionally, the first engagement portion comprises a proximally facing surface. Optionally, the second engagement portion comprises a distally facing surface. Optionally, the first engagement portion and/or the second engagement portion is a protrusion.
Generally, all terms used in the claims are to be interpreted according to their ordinary meaning in the technical field, unless explicitly defined otherwise herein. All references to a/an/the element, apparatus, member, component, means, etc. are to be interpreted openly as referring to at least one instance of the element, apparatus, member component, means, etc., unless explicitly stated otherwise.
Embodiments of the present disclosure will now be described by way of example only and with reference to the following accompanying drawings.
The plunger rod 70 comprises a proximally facing surface (first surface) facing towards the proximal end and a component of the sub-assembly other than the plunger rod (in this case the housing, and more particularly the rear cap 62) comprises a distally facing surface (second surface) facing towards the distal end. In the example shown in the figures, the proximally facing surface is a surface 78 of a flexible arm 76, where the flexible arm extends from the main body of the plunger rod 70 (see
During use of a medicament delivery device comprising the sub-assembly, the plunger rod moves relative to the component (in this case the rear cap), resulting in the proximally facing surface and the distally facing surface engaging to flex the flexible arm relative to the component (and also relative to the main body of the plunger rod), and then subsequently disengaging so that the flexible arm flexes back relative to the component, which can create feedback (e.g. audible, visible and/or tactile feedback).
In general, during operation of the sub-assembly, the plunger rod moves in a proximal direction relative to another component so that a proximally facing surface of the plunger rod engages a distally facing surface of the another component, thereby flexing the flexible arm in a first direction relative to the another component. The plunger rod then moves further in the proximal direction relative to the another component so that the proximally facing surface of the flexible arm disengages the distally facing surface of the another component and subsequently the flexible arm flexes back in a second direction, thereby creating feedback. Typically, the first direction and the second direction are opposite directions. Typically, the flexing of the flexible arm is elastic.
This flexing back can be rapid, allowing for feedback (such as an audible click) due to an impact with another component.
The method of operation of the example sub-assembly in the figures will now be described in more detail. Once the plunger rod 70 has been released and is moving towards the proximal end of a medicament delivery device (i.e. moving in the proximal direction relative to the rear cap), the protrusion 67 of the rear cap and the flexible arm 76 of the plunger rod will engage one another. This can be at different points, for example this could be immediately upon the plunger rod moving (for feedback that an injection has started), at an intermediate point during injection, and/or at the end of an injection, for example.
Once the respective surfaces of the plunger rod and the rear cap engage one another, some of the energy from the power source that is driving the plunger rod is transferred to the flexible arm to flex the flexible arm.
Once the flexible arm has flexed to its full extent relative to the rear cap, continued movement of the plunger rod in the proximal direction relative to the rear cap will result in the respective surfaces of the plunger rod and the rear cap disengaging, which allows the energy built up in the flexible arm to be released, allowing the flexible arm to flex back.
The particular structure of the engagement portion of the plunger rod and the corresponding engagement portion of the rear cap will now be dealt with in more detail. In the example in the figures, a flexible arm is provided on the plunger rod, with a corresponding protrusion on the rear cap. The protrusion on the plunger rod could therefore be considered to be the engagement portion of the plunger rod, and the flexible arm of the rear cap could be considered to be the engagement portion of the rear cap.
As shown in more detail in the example in
As shown in
Providing more than one flexible arm 76 on the plunger rod could be beneficial. This plurality of flexible arms could be spaced out around the circumference of the plunger rod (with their corresponding protrusions correspondingly spaced out on another component). In such a case, each additional flexible arm (and corresponding protrusion) collects additional energy, thereby allowing for a stronger feedback (e.g. stronger audible feedback) due to the greater forces involved.
Although the examples herein provide the surfaces that engage one another as on a protrusion and on an outer surface of a flexible arm respectively, this is optional. For example, one of the surfaces could be on a protrusion, with the other surface being the wall of a slot (for example a helical slot), or one or more of the surfaces could be created by a discontinuity such as a step.
In the examples shown herein, the engagement portions (the surfaces that engage one another) are on the rear cap 62 and the plunger rod 70. Instead of being on the rear cap, the engagement portion could be on another component, such as on another part of the housing (e.g. an outer housing), a syringe carrier, or a rotator. A rotator in medicament delivery devices is typically rotatable relative to other components such as the housing and the plunger rod only at particular points during medicament delivery device use, and is rotationally restricted during other points, for example during medicament delivery. As such, the rotator can be used to house the engagement portion if the rotational state of the rotator is taken into account.
The plunger rod is typically rotationally locked relative to at least one other part of the sub-assembly, such as to the housing, for example by a protrusion and a groove arranged in the protrusion, wherein one of the protrusion and the groove is on the plunger rod and the other of the protrusion and the groove are on any component of the sub-assembly other than the plunger rod (e.g. on the housing, for example on the rear cap 62). The groove would typically be parallel to the longitudinal axis 12. Alternative mechanisms for restricting rotational movement of the plunger rod relative to one or more components could also be used; for example, when the powerpack comprises a compression spring as a power source, it may be that the spring can restrict rotational movement of the plunger rod relative to the housing by providing resistance to rotational movement of the plunger rod relative to the housing. In such a case, a protrusion and groove combination as outlined above would not be needed.
In the examples shown herein, the plunger rod 70 is held in place before use within the rear cap 62 by an arm 64 of the rear cap 62 interacting with a hole 75 of the plunger rod 70 (see
Various other modifications could be made to the example shown for the shape of the flexible arm 76 and the protrusion 67. A selection of alternative shapes for the flexible arm 76 and the protrusion 67 are shown in
In the example in
It is envisioned that two flexible arms 76 would be provided on the plunger rod, with two corresponding protrusion 67 on the rear cap. Typically, the two flexible arms 76 would be opposite each other relative to the longitudinal axis, and the two protrusions 67 would also be opposite to each other relative to the longitudinal axis, though this is optional and a different spacing could also be used. Alternatively, one, three or more flexible arms 76 could be provided, with the flexible arms optionally equally spaced around the axis. Generally, a protrusion 67 on the rear cap would be provided for each flexible arm 76 on the plunger rod.
Typically, at least one of the protrusion on the rear cap and the protrusion on the plunger rod comprises a surface (such as the surface 78) that is angled relative to a plane perpendicular to the longitudinal axis; that is, a surface that extends in a direction with an angle of greater than zero degrees and less than 90 degrees relative to a plane perpendicular to the longitudinal axis, for example between 10 and 85 degrees. Preferably, the angle is between 30 and 70 degrees, or between 45 and 60 degrees. The examples of the surface 78 shown in the figures all have a constant angle, but the angle could also vary, and could for example be curved when viewed from the angle shown in
In the example in
The particular shape of the rear cap 62 shown in the figures can be varied, and various other optional rear cap features, such as a powerpack transport locking arm 63, a pre-activation locking arm 64 and syringe support arms 65, are shown but are not described in detail as they are not directly relevant to providing feedback. The plunger rod is shown inside the rear cap in the depicted examples (i.e. the plunger rod is arranged at least partly inside the housing-at least partly inside the rear cap of the housing in these examples), with the protrusion of the rear cap extending from an inner surface of the rear cap, but this could be reversed, with the protrusion of the rear cap extending from an outer surface of the rear cap (for example from an outer surface of a tubular extension of the rear cap that extends inside the distal end of the plunger rod).
In this application, it is primarily envisioned that the feedback would be provided at the beginning or end of delivery, but the time of the feedback could be adjusted by adjusting the relative locations of the features described above. Optionally, multiple instances of feedback could be provided, for example with a selection from a start of delivery feedback, an end of delivery feedback, and ‘continuous’ feedback during delivery (i.e. multiple closely spaced clicks providing multiple instances of feedback). Two (or more) instances of feedback could be achieved by two (or more) flexible arms on the plunger rod at different axial positions and/or by two (or more) protrusions on another component (e.g. on a housing, such as the rear cap) at different axial positions. The feedback could be audible, tactile and/or visible, for example.
The drug delivery devices described herein can be used for the treatment and/or prophylaxis of one or more of many different types of disorders. Exemplary disorders include, but are not limited to: rheumatoid arthritis, inflammatory bowel diseases (e.g. Crohn's disease and ulcerative colitis), hypercholesterolaemia, diabetes (e.g. type 2 diabetes), psoriasis, migraines, multiple sclerosis, anaemia, lupus, atopic dermatitis, asthma, nasal polyps, acute hypoglycaemia, obesity, anaphylaxis and allergies. Exemplary types of drugs that could be included in the medicament delivery devices described herein include, but are not limited to, antibodies, proteins, fusion proteins, peptibodies, polypeptides, pegylated proteins, protein fragments, protein analogues, protein variants, protein precursors, and/or protein derivatives. Exemplary drugs that could be included in the drug delivery devices described herein include, but are not limited to (with non-limiting examples of relevant disorders in brackets): etanercept (rheumatoid arthritis, inflammatory bowel diseases (e.g. Crohn's disease and ulcerative colitis)), evolocumab (hypercholesterolaemia), exenatide (type 2 diabetes), secukinumab (psoriasis), erenumab (migraines), alirocumab (rheumatoid arthritis), methotrexate (amethopterin) (rheumatoid arthritis), tocilizumab (rheumatoid arthritis), interferon beta-1a (multiple sclerosis), sumatriptan (migraines), adalimumab (rheumatoid arthritis), darbepoetin alfa (anaemia), belimumab (lupus), peginterferon beta-1a′ (multiple sclerosis), sarilumab (rheumatoid arthritis), semaglutide (type 2 diabetes, obesity), dupilumab (atopic dermatis, asthma, nasal polyps, allergies), glucagon (acute hypoglycaemia), epinephrine (anaphylaxis), insulin (diabetes), atropine and vedolizumab (inflammatory bowel diseases (e.g. Crohn's disease and ulcerative colitis)). Pharmaceutical formulations including, but not limited to, any drug described herein are also contemplated for use in the drug delivery devices described herein, for example pharmaceutical formulations comprising a drug as listed herein (or a pharmaceutically acceptable salt of the drug) and a pharmaceutically acceptable carrier. Pharmaceutical formulations comprising a drug as listed herein (or a pharmaceutically acceptable salt of the drug) may include one or more other active ingredients, or may be the only active ingredient present.
Various modifications to the embodiments described are possible and will occur to those skilled in the art without departing from the invention which is defined by the following claims.
Some aspects are outlined in the following clauses.
| Number | Date | Country | Kind |
|---|---|---|---|
| 22173147.4 | May 2022 | EP | regional |
The present application is a U.S. National Phase Application pursuant to 35 U.S.C. § 371 of International Application No. PCT/EP2023/054903 filed Feb. 28, 2023, which claims priority to (i) U.S. Provisional Patent Application No. 63/319,474 filed Mar. 14, 2022, and (ii) European Patent Application No. 22173147.4 filed May 13, 2022. The entire disclosure contents of these applications are herewith incorporated by reference into the present application.
| Filing Document | Filing Date | Country | Kind |
|---|---|---|---|
| PCT/EP2023/054903 | 2/28/2023 | WO |
| Number | Date | Country | |
|---|---|---|---|
| 63319474 | Mar 2022 | US |