A CAP FOR A MEDICAMENT DELIVERY DEVICE
TECHNICAL FIELD
The present disclosure generally relates to medical devices for medicament administration.
BACKGROUND
A number of medical conditions require injections. These days, a number of different injection devices exist, including various types of pen injectors, autoinjectors and on-body devices. Although many of these devices have enabled major improvements in the management of a number of medical conditions, various limitations do still exist in the current technology.
The medicament is typically comprised in a medicament container within the medicament delivery device, the medicament container being configured to expel the medicament via some type of delivery member, such as a needle. A medicament delivery action may be activated by activating a drive member configured to act on the medicament container, whereafter medicament is continuously expelled from the medicament container via the needle until the end of the medicament delivery action. In order to protect the needle, and not initiate unintentional activation of the drive member, the medicament delivery device may comprise a cap. Moreover, the needle may be further protected by a rigid needle shield, RNS or a flexible needle shield, FNS. Thus, prior to initiating activation of the device, the cap should be removed, as well as the needle shield (RNS/FNS) of the medicament container. For example, the cap may comprise an needle shield remover configured to remove the needle shield upon cap removal. However, upon cap removal, the resulting force may result in detachment of the needle shield remover from the remaining parts of the cap, or unsuccessful removal of the needle shield.
In considering these problems, the applicant has appreciated that various developments could be made to help improve the medicament delivery devices on the market today, which are set out in more detail below.
SUMMARY
An object of the present disclosure is to provide a cap for a medicament delivery device, and a medicament delivery device, which solves, or at least mitigates problems of the prior art. There is hence provided a cap for a medicament delivery device having a medicament container. The cap comprises: a needle shield remover configured to remove a needle shield of the medicament container, the needle shield remover having a tubular body extending axially from a proximal end to a distal end, the tubular body having an outer surface comprising a distally facing rim; and a cap body having an inner opening for receiving the tubular body of the needle shield remover and a rim support extending around the inner opening, wherein the needle shield remover is accommodated in a first state by the inner opening such that the rim support supports the distally facing rim of the needle shield remover, and wherein the rim support comprises a flexible rim portion arranged to reduce a diameter of the inner opening when being subject to an axial force by the distally facing rim.
Hereby, separation of the needle shield remover and the cap body is prevented, or the risk thereof at least reduced. That is, as the flexible rim portion is subject to an axial force by the distally facing rim, typically as the cap is to be removed and the needle shield detached from the medicament container by the needle shield remover, the flexible rim portion flexes inwards, or collapses, or is bent, such that the diameter of the inner opening is reduced. Hereby, movement of the distally facing rim pass the rim support such that the distally facing rim becomes arranged distally of the rim support is prevented, or the risk thereof at least reduced. For example, the overlap between the distally facing rim and the flexible rim portion may increase as the diameter of the inner opening is reduced, thus increasing the contacting surface between the distally facing rim and the flexible rim portion of the rim support in the first state. Hereby, any interacting structures between the needle shield remover and the needle shield of the medicament container can be made stronger, improving the removal of the needle shield e.g. by increasing the reliability of needle shield removal. According to one embodiment, the needle shield remover is connected to the cap body only by the interaction by the distally facing rim and the rim support. Thus, in case the needle shield remover is passed through the inner opening of the cap body such that the distally facing rim becomes arranged distally of the rim support, the needle shield remover becomes de-attached from the cap body.
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 under 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 under use of the medicament delivery device is/are located closest to the dose delivery site.
Further, the term “longitudinal”, “longitudinally”, “axially” or “axial” refer to a direction extending from the proximal end to the distal end, typically along the device or components thereof 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.
Further, the terms “circumference”, “circumferential”, or “circumferentially” refer to a circumference or a circumferential direction relative to an axis, typically a central axis extending in the direction of the longest extension of the device and/or component.
Similarly, “radial” or “radially” refer to a direction extending radially relative to the axis, and “rotation”, “rotational” and “rotationally” refer to rotation relative to the axis.
According to one embodiment, the flexible rim portion comprises a supporting surface.
According to one embodiment, the supporting surface extends from the flexible rim portion and moves radially inwards when the flexible rim portion is subject to an axial force by the distally facing rim.
According to one embodiment, the supporting surface arranged to at least partly face the distally facing rim of the needle shield remover in the first state. The supporting surface may e.g. be defined by the surface of the flexible rim portion that is in contact with the distally facing rim in the first state of the needle shield remover. Thus, the as the flexible rim portion flexes, or collapses, to reduce the diameter of the inner opening of the cap body, the supporting surface moves radially inwards. Additionally, or alternatively, the supporting surface may be defined as delimited surface as compared to other surface(s) of the flexible rim portion. The flexible rim portion may e.g. comprise a secondary surface delimited from the supporting surface, e.g. by that the secondary surface and the supporting surface are facing in different directions. The secondary surface is typically arranged not to be in contact with the distally facing rim in the first state of the needle shield remover. The secondary surface may e.g. face away from the distally facing rim of the needle shield remover in the first state.
According to one embodiment, the supporting surface is facing at least partly in the proximal direction. Thus, the supporting surface may be referred to as a proximally facing supporting surface. By facing in the proximal direction, the previously described interaction between the supporting surface and the distally facing rim is facilitated, e.g. by an increased contacting surface between the distally facing rim and the flexible rim portion of the rim support in the first state.
According to one embodiment, the flexible rim portion is chamfered. By providing a chamfered flexible rim portion, the previously described interaction with the distally facing rim is facilitated. Moreover, by a chamfered flexible rim portion, the flexing movement of the rim portion can be controlled. That is, how the axial force is applied from the distally facing rim to the flexible rim portion can be controlled by chamfered flexible rim portion.
According to one embodiment, the flexible rim portion is chamfered by a predefined inclination of the supporting surface. Thus, how the axial force is applied from the distally facing rim to the flexible rim portion can be controlled by the predefined inclination of the supporting surface. As previously mentioned, the supporting surface may make up the surface of the flexible rim portion which is in contact with the distally facing rim in the first state of the needle shield remover. Thus, the axial force may be applied from the distally facing rim to the flexible rim portion via the supporting surface, wherein the predefined inclination of the supporting surface is chosen such that the applied force is distributed in a desired manner to the flexible rim portion. Thus, the flexing movement, or collapses, of the flexible rim portion is at least partly controlled by the predefined inclination of the supporting surface. The flexible rim portion may be chamfered by other inclined surface(s), such as e.g. the previously mentioned secondary surface. The direction of inclination of the secondary surface may e.g. be opposite that of the direction of inclination of the supporting surface. It should be noted that the supporting surface may alternatively be flat, i.e. not being inclined.
According to one embodiment, the distally facing rim comprises an interacting surface arranged to abut the supporting surface in the first state of the needle shield remover, wherein the inclination of the interacting surface matches that of the supporting surface. Thus, the force distribution between the distally facing rim and the flexible rim portion is improved. It should be noted that regardless of the inclination of the interacting surface, the distally facing rim may comprise an interacting surface arranged to abut the supporting surface in the first state of the needle shield remover.
According to one embodiment, the inclination of the supporting surface is below 45 degrees relative to a transversal axis being perpendicular to the axial direction. By providing a supporting surface having an inclination of below 45 degrees relative to the transversal axis, the flexing movement of the rim portion can be better controlled. Typically, by an inclination of the supporting surface below 45 degrees relative to the transversal axis, the flexible rim portion may be more easily controlled to flex radially inwards, and not outwards, wherein the inner opening of the cap body will be reduced.
According to one embodiment, the flexible rim portion comprises at least one radially extending slot. Hereby, the flexibility of the rim portion can be adapted in an advantageous manner. The slot may e.g. extend radially along the whole supporting surface, and potentially along the whole secondary surface. For example, the slot may extend radially along the whole flexible rim portion. The slot may be one or a plurality of slots. For embodiments in which the slot is a plurality of slots, the plurality of slots may be evenly distributed around the inner opening. For example, four slots may be evenly distributed around the inner opening.
According to one embodiment, the tubular body of the needle shield remover is axially movable within the inner opening and wherein the distally facing rim and rim support are arranged to stop the axial movement of the tubular body in the first state of the needle shield remover. Hereby, an axial play of the needle shield remover is provided. However, it should be mentioned that the needle shield remover may be fixedly arranged in the first state, providing no axial play of the needle shield remover.
According to one embodiment, the flexible rim portion is pivotable about a pivot point, wherein the distally facing rim and rim support are arranged such that the axial force by the distally facing rim in the first state of the needle shield remover has a point of application proximally of the pivot point. Hereby, the flexing movement of the rim portion can be better controlled. Typically, by such proximally point of application of the axial force relative to the pivot point, the flexible rim portion may be more easily controlled to flex radially inwards, and not outwards, wherein the inner opening of the cap body will be reduced.
According to one embodiment, the distally facing rim and rim support are arranged such that the resulting force by the applied axial force has a direction extending distally of the pivot point. Hereby, the flexing movement of the rim portion can be better controlled.
According to one embodiment, the needle shield remover comprises a locking structure arranged in a distal end portion of the tubular body, the locking structure being arranged to lockingly interact with the needle shield of the medicament container. Hereby, an advantageous locking interaction between the needle shield remover and the needle shield of the medicament container is provided. The locking structure may e.g. be comprised of a snap-lock. For example, the locking structure of the needle shield remover comprises locking protrusions, and the needle shield comprises locking indentations arranged to lockingly interact with the locking protrusions in a snap-lock configuration.
According to one embodiment, the distally facing rim is extending circumferentially around the outer surface of the tubular body. Hereby, the contacting surface between the distally facing rim and the flexible rim portion of the rim support can be increased in the first state. Thus, the applied axial force may be better distributed to the flexible rim portion.
According to one embodiment, the outer surface of the tubular body comprises a base portion having a first diameter, wherein the distally facing rim has a second diameter greater than the first diameter. Hereby, the dimension of the inner opening of the cap body, and the flexible rim portion, may be more easily adapted to achieve the desired functionality.
According to one embodiment, the inner opening has a diameter smaller than the second diameter and greater than the first diameter of the tubular body of the needle shield remover. Hereby, the tubular body may be arranged to move axially in the inner opening of the cap body, but not to a position in which the distally facing rim is arranged distally of the inner opening.
According to a second aspect of the present disclosure, there is provided a medicament delivery device for expelling medicament from a medicament container, the medicament delivery device comprising the cap according to the first aspect. Effects and features of the second aspect are largely analogous to those described above in connection with the first aspect. Embodiments mentioned in relation to the first aspect are largely compatible with the second aspect. The medicament delivery device is typically configured to expel medicament from the medicament container after cap removal.
According to one embodiment, applicable to any one of the first and second aspects of the disclosure, the medicament container is a syringe. The medicament container typically comprises a medicament delivery member in the form of a needle, which is protected by the needle shield.
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, component, means, etc.” are to be interpreted openly as referring to at least one instance of the element, apparatus, component, means, etc., unless explicitly stated otherwise.
BRIEF DESCRIPTION OF THE DRAWINGS
The specific embodiments of the inventive concept will now be described, by way of example, with reference to the accompanying drawings, in which:
Fig. l is a perspective view of a medicament delivery device according to embodiments of the present disclosure;
Fig. 2 is an exploded view of a medicament container and a cap of the medicament delivery device according to embodiments of the present disclosure;
Fig. 3 is a perspective view of the cap body of the cap according to embodiments of the present disclosure;
Fig. 4 is a perspective view of a rim support of the cap body and a needle shield remover of the cap according to embodiments of the present disclosure;
Fig. 5 is a perspective view of the rim support and the needle shield remover of Fig. 4 in an assembled state according to embodiments of the present disclosure; Figs. 6A and 6B are a cross sectional views of the needle shield remover accommodated in a first state in an inner opening of the cap body according to embodiments of the present disclosure; and
Fig. 7 is a perspective view of a rim support of the cap body according to embodiments of the present disclosure.
DETAILED DESCRIPTION
The inventive concept will now be described more fully hereinafter with reference to the accompanying drawings, in which exemplifying embodiments are shown. The inventive concept may, however, be embodied in many different forms and should not be construed as limited to the embodiments set forth herein; rather, these embodiments are provided by way of example so that this disclosure will be thorough and complete, and will fully convey the scope of the inventive concept to those skilled in the art. Like numbers refer to like members throughout the description.
Fig 1 shows an example of a medicament delivery device 1 such as an autoinjector of an injection device, or a subassembly of an autoinjector, according to embodiments of the present disclosure. The medicament delivery device 1 is configured to expel medicament from a medicament container 15 via a medicament delivery member, e.g. a needle, to a user at a dose delivery site. The medicament delivery device 1 extends from a proximal end la to a distal end lb relative to the axis 112. A needle cover 5 is arranged at the proximal end 1 a and is configured to cover, and exposing, the needle by moving axially. The cap 20 in Fig. 1 may be removably attached to the needle cover 5, protecting the needle and unintentional activation of the medicament delivery device 1.
The medicament delivery device 1 may comprise a medicament container carrier 4 for holding the medicament container 15. The medicament container carrier 4 is preferably tubular or substantially tubular. For example, the medicament container carrier 4 comprises a carrier wall which is cylindrically shaped, the carrier wall radially surrounding the medicament container 15. The medicament container carrier 4 may e.g. be configured to fit inside an outer housing (not shown).
After removal of the cap 20 from the needle cover 5, the medicament delivery device 1 may be triggered to discharge medicament, or at least triggered to allow activation, by movement of the needle cover 5, typically in the distal direction. For example, the medicament delivery device 1 may comprises a drive member 19 (schematically shown in Fig. 1), such as a biased hollow drive member or expulsion member, e.g. a plunger rod. The drive member 19 may be configured to be moved axially inside the medicament container carrier 4 upon activation. Such activation may e.g. be achieved by an actuator arranged in the distal end lb of the medicament delivery device 1, or by activation upon movement of the needle cover 5. During such medicament delivery operation, the drive member 19 is typically configured to be moved proximally from a first axial position. For providing the biased condition, a spring, such as a coil spring, may be arranged inside the medicament delivery device 1. For example, when the needle cover 5 is moved distally, the drive member 19 is released, or is enabled to be released by activating the actuator, from its biased condition. For example, the drive member 19 may be held in its biased condition by means of a holding sleeve or the like. The holding sleeve may be displaced to release the drive member 19 from its biased condition by means of the actuator and/or by means of movement of the needle cover 5. Thus, according to one example, when the needle cover 5 is moved distally from the first state, a linear movement of the needle cover 5 is transformed into the holding sleeve, which moves to release the drive member 19. According to some variations, the drive member 19 could for example be motor driven or manually driven instead of having a spring-loaded structure.
The axis 112 is in Fig. 1 a centre axis, from which a circumferential direction 131 relative to the centre axis 112 and a radial direction 132 extending radially relative to the centre axis 112, can be defined.
Fig. 2 is an exploded view of at least a part of the medicament delivery device 1 in Fig. 1. In Fig. 2, the medicament container 15 is shown together with a rigid needle shield, RNS, 17 arranged to protect the needle of the medicament container 15. However, it should be mentioned that the needle shield may be a flexible needle shield, FNS. Thus, the needle shield may be referred to as an RNS/FNS. The previously mentioned drive member 19 is typically arranged to interact with the medicament container 15 via a distal portion 15b thereof (e.g. via a plunger or stopper).
The cap 20 comprises a needle shield remover 30 configured to remove the RNS 17 of the medicament container 15, typically during a cap removal action. Thus, the needle shield remover may be referred to as an RNS remover. The needle shield remover 30 comprises a tubular body 31 extending axially from a proximal end 31a to a distal end 31b, and having an outer surface 33. The tubular body 31 comprises a distally facing rim 35 arranged in the outer surface 33 at a proximal end portion of the needle shield remover 30.
The needle shield remover 30 comprises a locking structure 32 arranged in a distal end portion of the tubular body 31. The locking structure 32 is arranged to lockingly interact with the RNS 17 of the medicament container 15. In more detail, the locking structure 32 comprises at least one locking protrusion 32b extending radially inwards of the tubular body 31, and the RNS 17 comprises at least one locking indentation 17b arranged in a distal end portion of the RNS 17. The at least one locking protrusion 32b is arranged to lockingly interact with the locking indentation 17b, e.g. in a snap-lock configuration. Hereby, the cap 20, and the needle shield remover 30, may be lockingly attached to the RNS 17. Thus, upon a cap removal action, the cap 20 is removed together with the RNS 17, resulting in an exposure of the needle of the medicament container 15. However, it should be mentioned that the RNS 17 need not to comprise a locking indentation, as the at least one locking protrusion 32b may simply grip the outer surface of the RNS 17 to lockingly attached to the RNS 17.
With further reference to Fig. 3, the cap 20 further comprises a cap body 40 having an inner opening 42 for receiving the tubular body 31 of the needle shield remover 30. Thus, the cap 20 comprises at least two separate components, i.e. the needle shield remover 30 and the cap body 40, which are attached to each other. The cap body 40 comprises a rim support 44 extending around the inner opening 42. The distally facing rim 35 and the rim support 44 are arranged to interact such that the tubular body 31 does not become removed from the inner opening 42, which would result in that the needle shield remover 30 would become separated from the cap body 40, during a cap removal action. Thus, the needle shield remover 30 may be accommodated in a first state by the inner opening 42 such that the rim support 44 supports the distally facing rim 35 of the needle shield remover 30 (better shown in Fig. 5), preventing the tubular body 31 from being removed from the inner opening 42.
Fig. 4 is a perspective view of the rim support 44 of the cap body 40, and the needle shield remover 30, shown separately, and Fig. 5 is a perspective view of the needle shield remover 30 accommodated in the first state in the inner opening 42 of the cap body 40. Thus, in Fig. 5, the needle shield remover 30 is shown assembled with the cap body 40. As seen in Fig. 4, the opening 42 of the cap body 40 has a diameter dl. The rim support 44 further comprises a flexible rim portion 46 arranged closest to the inner opening 42. The flexible rim portion 46 is arranged to reduce the diameter dl of the inner opening 42 when being subject to an axial force by the distally facing rim 35, when the needle shield remover is arranged in the first state, as shown in Fig. 5. In more detail, the flexible rim portion 46 comprises a supporting surface 47 arranged to at least partly face the distally facing rim 35 in the first state of the needle shield remover 30. In the example of Figs. 4-5, the supporting surface 47 is facing at least partly in the proximal direction. Moreover, the distally facing rim 35 comprises an interacting surface 37 arranged to abut the supporting surface 47 in the first state of the needle shield remover 30.
As shown best in Fig. 4, the distally facing rim 35 is extending circumferentially around the outer surface 33 of the tubular body 31. Here, the distally facing rim 35 is continuous, but it should be mentioned that the distally facing rim 35 may as well be formed by one or more separate distally facing rims, or rim portions. For example, the distally facing rim may be periodically forged or cut such that the distally facing rims or rim portions are arranged intermittently around the periphery of the tubular body 31.
The flexible rim portion 46 may comprise a secondary surface 48 delimited from the supporting surface 47. In the example of Figs. 4-5, the secondary surface 48 and the supporting surface 47 are facing in different directions. The secondary surface is typically arranged to face away from the distally facing rim 35 of the needle shield remover 30 in the first state. As shown in Fig. 5, the secondary surface 48 is arranged distant from the distally facing rim 35, and is thus not in contact with the distally facing rim 35, in the first state of the needle shield remover 30. The secondary surface 48 may extend further distally as compared to the supporting surface 47.
That is, as the cap 20 is removed, and as the needle shield remover 30 lockingly interact with the RNS 17 of the medicament container 15 to detach the RNS 17 for needle exposure as previously described, the flexible rim portion 46 is subject to an axial force by the distally facing rim 35. As the axial force is applied, or transmitted, to the flexible rim portion 46, the flexible rim portion 46 moves or flexes inwards, or collapses, such that the diameter dl of the inner opening 42 is reduced, described in more detail later and shown in Fig. 6B. Hereby, movement of the distally facing rim 35 pass the rim support 44 such that the distally facing rim 35 becomes arranged distally of the rim support 44 is obstructed. Thus, the risk of removal of the tubular body 31 from the inner opening 42 is reduced. Typically, the maximum axial force which is applied to the flexible rim portion 46 during a cap removal action is at least corresponding to the force needed for detaching the RNS 17 from its position protecting the needle of the medicament container 15. Thus, the flexible rim portion 46 is preferably adapted to handle such maximum axial force, i.e. to prevent the distally facing rim 35 to pass the rim support 44 such that the distally facing rim 35 becomes arranged distally of the rim support 44. In the hypothetical case of subjecting the flexible rim portion 46 to an even larger axial force resulting in that the tubular body 31 is passed through the inner opening 42 of the cap body 40 whereby the distally facing rim 35 becomes arranged distally of the rim support 44, the needle shield remover 30 would become de-attached from the cap body 40.
The tubular body 31 of the needle shield remover 30 may be axially movable within the inner opening 42. Thus, the distally facing rim 35 and rim support 44 may be arranged to stop the axial movement of the tubular body 31 in the first state of the needle shield remover 30. In more detail, and as best shown in Fig. 4, the outer surface 33 of the tubular body 31 comprises a base portion 34 having a first diameter DI. The base portion 34 may be tubular, or cylindrically shaped, having a uniform shape with a constant first diameter DI along the axial direction of the needle shield remover 30. Moreover, the distally facing rim 35 has a second diameter D2 greater than the first diameter DI. The distally facing rim 35 may extend radially outwards from the base portion 34. The second diameter D2 is typically defined as the maximum diameter of the distally facing rim 35, i.e. its diameter between is outmost radial end portions. Thus, in case the diameter dl of the inner opening 42 is smaller than the second diameter D2 (of the distally facing rim 35) and greater than the first diameter Dl (of the base portion 34), the tubular body 31 of the needle shield remover 30 is axially movable within the inner opening 42 up to a position of the needle shield remover 30 at which the rim support 44 abuts the distally facing rim 35 to stop further axial movement of the tubular body 31 in the distal direction relative to the cap body 40 (i.e. in the first state of the needle shield remover 30).
Figs. 6A and 6B are a cross sectional views of the needle shield remover 30 accommodated in the first state in the inner opening 42 of the cap body 40. As seen in Fig. 6A, the interacting surface 37 of the distally facing rim 35 abuts the supporting surface 47 in the first state of the needle shield remover 30. Moreover, in the example of Fig. 6A, the flexible rim portion 46 is chamfered by a predefined inclination of the supporting surface 47. The predefined inclination is just below 45 degrees relative to a transversal axis T, the transversal axis being perpendicular to the axial direction of the cap 20 and the needle shield remover 30. As also seen in Fig. 6 A, the inclination of the interacting surface 37 matches that of the supporting surface 47. Thus, at least a sub-portion of the interacting surface 37 has an inclination which matches the inclination of the supporting surface 47. However, as also shown in Fig. 6A, the distally facing rim 35 may be curved, and thus have a varying inclination along the axial direction. Moreover, the distally facing rim 35 may form part of a brim 36 comprising the distally facing rim 35 and a proximally facing rim arranged opposite the distally facing rim 35. The proximally facing rim may be mirrored-shaped with regards to the distally facing rim 35. Thus, the brim 36 may be bump-shaped, or curved as a semi-circle.
In Fig. 6B, the previously described inwards flexing movement of flexible rim portion 46 to reduce the diameter dl of the inner opening 42 is shown. That is, in Fig. 6B, the flexible rim portion 46 is subject to an applied axial force from the distally facing rim 35, typically as the cap 20 is removed and as the needle shield remover lockingly interact with the RNS 17 of the medicament container 15 to detach the RNS 17 for needle exposure. As seen in Fig. 6B, the flexible rim portion 46 is pivotable about a pivot point P. As also shown in Fig. 6B, the distally facing rim 35 and rim support 44 are arranged such that the axial force by the distally facing rim 35 in the first state of the needle shield remover 30 has a point of application p proximally of the pivot point P. In other words, in the first state of the needle shield remover 30, the pivot point P is arranged distally of the interacting surface 37. Moreover, the distally facing rim 35 and rim support 44 are arranged such that the resulting force by the applied axial force from the distally facing rim 35 has a direction extending distally of the pivot point P. That is, the resulting force from the axial and transversal force components has a direction extending both radially and distally from the point of application p, wherein the direction of that resulting force extends along a force axis extending to a position distally of the pivot point P. Hereby, the flexing movement of the flexible rim portion 46 can be better controlled, typically such that the supporting surface 47 moves radially inwards. Typically, by such proximal point of application p of the axial force relative to the pivot point P, the flexible rim portion 46 may be more easily controlled to flex radially inwards, and not outwards, wherein the inner opening 42 of the cap body 40 will be reduced, as shown in Fig. 6B. That is, the diameter dl of the inner opening 42 is smaller in Fig. 6B compared to in Fig. 6A. Thus, when being subject to a load (by the previously described applied force of the distally facing rim 35), the flexible rim portion 46 flex radially inwards, wherein the inner opening 42 of the cap body 40 will be reduced.
Turning to Fig. 7 showing an alternative embodiment of a rim support 144. The rim support 144 may correspond to the previously described rim support 44 except for the differences mentioned in the following. Thus, the rim support 144 may form a part of the cap body 40 and the cap 20 instead of the rim support 44. The rim support 144 of Fig. 7 comprises a flexible rim portion 146 comprising at least one radially extending slot 149, here exemplified as four radially extending slots 149 arranged evenly around the inner opening 142. By the slot(s) 149, the flexibility of the flexible rim portion 146 can be adapted in an advantageous manner. For example, the overall flexibility of the flexible rim portion 146 is increased, and thus the reduction of the diameter dl of the inner opening 142 will change correspondingly (i.e. increase under the same load). As shown in Fig. 7, each one of the slots 149 extend radially along the whole supporting surface 147, and into the secondary surface 148 of the flexible rim portion 146. As also shown in Fig. 7, the supporting surface 147 is shown as comprising a plurality of supporting surface portions. That is, due to the slot(s) 149, the supporting surface 147 is cut into a plurality of supporting surface portions.
The medicament 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 and/or dyslipidemia, cardiovascular disease, diabetes (e.g. type 1 or 2 diabetes), psoriasis, psoriatic arthritis, spondyloarthritis, hi dradenitis suppurativa, Sjogren's syndrome, migraine, cluster headache, multiple sclerosis, neuromyelitis optica spectrum disorder, anaemia, thalassemia, paroxysmal nocturnal hemoglobinuria, hemolytic anaemia, hereditary angioedema, systemic lupus erythematosus, lupus nephritis, myasthenia gravis, Behcet's disease, hemophagocytic lymphohistiocytosis, atopic dermatitis, retinal diseases (e.g., age-related macular degeneration, diabetic macular edema), uveitis, infectious diseases, bone diseases (e.g., osteoporosis, osteopenia), asthma, chronic obstructive pulmonary disease, thyroid eye disease, nasal polyps, transplant, acute hypoglycaemia, obesity, anaphylaxis, allergies, sickle cell disease, Alzheimer’s disease, Parkinson’s disease, dementia with Lewy bodies, systemic infusion reactions, immunoglobulin E (IgE)-mediated hypersensitivity reactions, cytokine release syndrome, immune deficiencies (e.g., primary immunodeficiency, chronic inflammatory demyelinating polyneuropathy), enzyme deficiencies (e.g., Pompe disease, Fabry disease, Gaucher disease), growth factor deficiencies, hormone deficiencies, coagulation disorders (e.g., hemophilia, von Willebrand disease, Factor V Leiden), and cancer.
Exemplary types of drugs that could be included in the medicament containers, and administrated by the medicament delivery devices described herein include, but are not limited to, small molecules, hormones, cytokines, blood products, enzymes, vaccines, anticoagulants, immunosuppressants, antibodies, antibody-drug conjugates, neutralizing antibodies, reversal agents, radioligand therapies, radioisotopes and/or nuclear medicines, diagnostic agents, bispecific antibodies, proteins, fusion proteins, peptibodies, polypeptides, pegylated proteins, protein fragments, nucleotides, protein analogues, protein variants, protein precursors, protein derivatives, chimeric antigen receptor T cell therapies, cell or gene therapies, oncolytic viruses, or immunotherapies.
Exemplary drugs that could be included in the medicament containers, and administrated by the medicament delivery devices described herein include, but are not limited to, immunooncology or bio-oncology medications such as immune checkpoints, cytokines, chemokines, clusters of differentiation, interleukins, integrins, growth factors, coagulation factors, enzymes, enzyme inhibitors, retinoids, steroids, signaling proteins, pro-apoptotic proteins, anti-apoptotic proteins, T-cell receptors, B-cell receptors, or costimulatory proteins.
Exemplary drugs that could be included in the medicament containers, and administrated by the medicament delivery devices described herein include, but are not limited to, those exhibiting a proposed mechanism of action, such as human epidermal growth factor receptor 2 (HER-2) receptor modulators, interleukin (IL) modulators, interferon (IFN) modulators, complement modulators, glucagon-like peptide- 1 (GLP-1) modulators, glucose-dependent insulinotropic polypeptide (GIP) modulators, cluster of differentiation 38 (CD38) modulators, cluster of differentiation 22 (CD22) modulators, Cl esterase modulators, bradykinin modulators, C-C chemokine receptor type 4 (CCR4) modulators, vascular endothelial growth factor (VEGF) modulators, B-cell activating factor (BAFF), P-selectin modulators, neonatal Fc receptor (FcRn) modulators, calcitonin gene-related peptide (CGRP) modulators, epidermal growth factor receptor (EGFR) modulators, cluster of differentiation 79B (CD79B) modulators, tumor-associated calcium signal transducer 2 (Trop-2) modulators, cluster of differentiation 52 (CD52) modulators, B-cell maturation antigen (BCMA) modulators, enzyme modulators, platelet-derived growth factor receptor A (PDGFRA) modulators, cluster of differentiation 319 (CD319 or SLAMF7) modulators, programmed cell death protein 1 and programmed death-ligand 1 (PD-1/PD-L1) inhibitors/modulators, B-lymphocyte antigen cluster of differentiation 19 (CD 19) inhibitors, B-lymphocyte antigen cluster of differentiation 20 (CD20) modulators, cluster of differentiation 3 (CD3) modulators, cytotoxic T-lymphocyte- associated protein 4 (CTLA-4) inhibitors, T-cell immunoglobulin and mucin-domain containing-3 (TIM-3) modulators, T cell immunoreceptor with Ig and ITIM domains (TIGIT) modulators, V-domain Ig suppressor of T cell activation (VISTA) modulators, indoleamine 2,3-dioxygenase (IDO or INDO) modulators, poliovirus receptor-related immunoglobulin domain-containing protein (PVRIG) modulators, lymphocyte-activation gene 3 (LAG3; also known as cluster of differentiation 223 or CD223) antagonists, cluster of differentiation 276 (CD276 or B7-H3) antigen modulators, cluster of differentiation 47 (CD47) antagonists, cluster of differentiation 30 (CD30) modulators, cluster of differentiation 73 (CD73) modulators, cluster of differentiation 66 (CD66) modulators, cluster of differentiation wl37 (CDwl37) agonists, cluster of differentiation 158 (CD158) modulators, cluster of differentiation 27 (CD27) modulators, cluster of differentiation 58 (CD58) modulators, cluster of differentiation 80 (CD80) modulators, cluster of differentiation 33 (CD33) modulators, cluster of differentiation 159 (CD 159 or NKG2) modulators, glucocorticoid-induced TNFR-related (GITR) protein modulators, Killer Ig-like receptor (KIR) modulators, growth arrest-specific protein 6 (GAS6)/AXL pathway modulators, A proliferation-inducing ligand (APRIL) receptor modulators, human leukocyte antigen (HLA) modulators, epidermal growth factor receptor (EGFR) modulators, B-lymphocyte cell adhesion molecule modulators, cluster of differentiation wl23 (CDwl23) modulators, Erbb2 tyrosine kinase receptor modulators, endoglin modulators, mucin modulators, mesothelin modulators, hepatitis A virus cellular receptor 2 (HAVCR2) antagonists, cancer-testis antigen (CTA) modulators, tumor necrosis factor receptor superfamily, member 4 (TNFRSF4 or 0X40) modulators, adenosine receptor modulators, inducible T cell co-stimulator (ICOS) modulators, cluster of differentiation 40 (CD40) modulators, tumor-infiltrating lymphocytes (TIL) therapies, or T-cell receptor (TCR) therapies.
Exemplary drugs that could be included in the medicament containers, and administrated by the medicament delivery devices described herein include, but are not limited to: etanercept, abatacept, adalimumab, evolocumab, exenatide, secukinumab, erenumab, galcanezumab, fremanezumab-vfrm, alirocumab, methotrexate (amethopterin), tocilizumab, interferon beta-la, interferon beta-lb, peginterferon beta-la, sumatriptan, darbepoetin alfa, belimumab, sarilumab, semaglutide, dupilumab, reslizumab, omalizumab, glucagon, epinephrine, naloxone, insulin, amylin, vedolizumab, eculizumab, ravulizumab, crizanlizumab-tmca, certolizumab pegol, satralizumab, denosumab, romosozumab, benralizumab, emicizumab, tildrakizumab, ocrelizumab, ofatumumab, natalizumab, mepolizumab, risankizumab-rzaa, ixekizumab, and immune globulins.
Exemplary drugs that could be included in the medicament containers, and administrated by the medicament delivery devices described herein may also include, but are not limited to, oncology treatments such as ipilimumab, nivolumab, pembrolizumab, atezolizumab, durvalumab, avelumab, cemiplimab, rituximab, trastuzumab, ado-trastuzumab emtansine, famtrastuzumab 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, olaratumab, panitumumab, polatuzumab vedotin, ramucirumab, sacituzumab govitecan, tafasitamab, or margetuximab.
Exemplary drugs that could be included in the medicament containers, and administrated by the medicament delivery devices described herein include “generic” or biosimilar equivalents of any of the foregoing, and the foregoing molecular names should not be construed as limiting to the “innovator” or “branded” version of each, as in the non-limiting example of innovator medicament adalimumab and biosimilars such as adalimumab-afzb, adalimumab-atto, adalimumab-adbm, and adalimumab-adaz.
Exemplary drugs that could be included in the medicament containers, and administrated by the medicament delivery devices described herein also include, but are not limited to, those used for adjuvant or neoadjuvant chemotherapy, such as an alkylating agent, plant alkaloid, antitumor antibiotic, antimetabolite, or topoisomerase inhibitor, enzyme, retinoid, or corticosteroid. Exemplary chemotherapy drugs include, by way of example but not limitation, 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.
Exemplary drugs that could be included in the medicament containers, and administrated by the medicament delivery devices described herein also include, but are not limited to, analgesics (e.g., acetaminophen), antipyretics, corticosteroids (e.g. hydrocortisone, dexamethasone, or methylprednisolone), antihistamines (e.g., diphenhydramine or famotidine), antiemetics (e.g., ondansetron), antibiotics, antiseptics, anticoagulants, fibrinolytics (e.g., recombinant tissue plasminogen activator [r-TPA]), antithrombolytics, or diluents such as sterile water for injection (SWFI), 0.9% Normal Saline, 0.45% normal saline, 5% dextrose in water, 5% dextrose in 0.45% normal saline, Lactated Ringer’s solution, Heparin Lock Flush solution, 100 U/mL Heparin Lock Flush Solution, or 5000 U/mL Heparin Lock Flush Solution.
Pharmaceutical formulations including, but not limited to, any drug described herein are also contemplated for use in the medicament containers, and administrated by the medicament 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. Such formulations may include one or more other active ingredients (e.g., as a combination of one or more active drugs), or may be the only active ingredient present, and may also include separately administered or co-formulated dispersion enhancers (e.g. an animal-derived, human-derived, or recombinant hyaluronidase enzyme), concentration modifiers or enhancers, stabilizers, buffers, or other excipients.
Exemplary drugs that could be included in the medicament containers, and administrated by the medicament delivery devices described herein include, but are not limited to, a multimedication treatment regimen such as AC, Dose-Dense AC, TCH, GT, EC, TAC, TC, TCHP, CMF, FOLFOX, mF0LF0X6, mF0LF0X7, FOLFCIS, CapeOx, FLOT, DCF, FOLFIRI, FOLFIRINOX, FOLFOXIRI, IROX, CHOP, R-CHOP, RCHOP-21, Mini-CHOP, Maxi- CHOP, VR-CAP, Dose-Dense 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 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, OF AR, 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.
The inventive concept has mainly been described above with reference to a few examples. However, as is readily appreciated by a person skilled in the art, other embodiments than the ones disclosed above are equally possible within the scope of the inventive concept, as defined by the appended claims.