Patent Application
20250018131
This invention relates to a medicament delivery device, and in particular, to a medicament delivery device that includes a rupturable container that contains a medicament and a propellant.
Medicament delivery devices facilitate the delivery of a dose of medicament to a user. In certain known medicament delivery devices, the medicament is stored in its liquid or solid phase and is suspended or otherwise mixed with a propellant in a container. Upon opening of the container, the propellant expands and/or vaporizes and is channeled towards the delivery site, such as the nasal cavity or mouth of the user. In doing so, the propellant carries the medicament such that the user receives a dose of the medicament.
For many medicaments, it is important that an accurate dose of medicament is delivered to the desired delivery site. In order to achieve this, a specific volume of medicament must be released from the container and the propellant must be released from the container in a manner that provides the necessary mechanism to deliver the complete dose of medicament to the delivery site. If the medicament comprises large solid particles, there is a risk that insufficient agitation of the medicament particles results in an inadequate dose of medicament being delivered to the delivery site. Another risk is that medicament particles clump together (e.g. in storage or transit of the medicament delivery device or container) and this detrimentally affects the accuracy of the dose delivered to the delivery site.
EP2271388B1, the content of which is incorporated herein in its entirety, describes a particulate dispenser that is particularly suited for delivering a dose of medicament wherein a mechanism is provided for deaggregating and agitating a particulate so that it may be dispensed as a fluid.
It is an object of embodiments of the present invention to provide an improved medicament delivery device that overcomes one or more problems associated with prior art devices.
In accordance with an aspect of the present invention there is provided a medicament delivery device comprising:
In such embodiments, once the needle hub is engaged with the casing, relative rotation therebetween is prevented. Consequently, the orientation of the needle relative to the casing will not change during transit, storage or use of the device. This ensures that the needle remains in the desired orientation relative to the casing, as determined during assembly. Thus, provided that the needle is orientated for optimal rupturing of the rupturable container during assembly (e.g. so that a beveled end of the needle is in a particular orientation), this orientation will not be compromised during transit, storage or use of the medicament delivery device. As a result, the reliability of the medicament delivery device is improved, since the rupturable container may be ruptured at the same point across multiple uses of the same medicament delivery device and across multiple medicament delivery devices assembled in the same manner.
In certain embodiments, the needle hub may have a radially internal or external profile such that circumferential interference between the needle hub and the casing prevents rotation of the needle hub relative to the casing about an axis parallel to the longitudinal axis when the needle hub is engaged with the casing. This offers a particularly effective means for limiting relative rotation between the needle hub and the casing.
In certain embodiments, one of the needle hub and the casing may include a protrusion that extends radially relative to the longitudinal axis, and the other of the needle hub and the casing includes a recess for receiving the protrusion when the needle hub is engaged with the casing, wherein circumferential interference between the protrusion and the recess prevents rotation of the needle hub relative to the casing about an axis parallel to the longitudinal axis. In addition to preventing rotation of the needle hub relative to the casing, insertion of the protrusion in the recess additionally determines the rotational orientation of the needle hub relative to the casing in which the needle hub may be engaged with the casing. Such an embodiment ensures that assembly can only result in a medicament delivery device wherein the needle (e.g. and a beveled end of the needle) is in a desired/optimal orientation. In alternative embodiments, reference indicia (e.g. visual or tactile markers) may be used during assembly to ensure the desired orientation of the needle hub relative to the casing.
In certain embodiments, the protrusion may comprise an axially extending rib and the recess may comprise an axially extending slot for receiving the axially extending rib. This offers a particularly effective means for limiting relative rotation between the needle hub and the casing and determining a permitted orientation of the needle hub in which it may be engaged with the casing. The axially extending rib received in the recess may additionally stabilize the needle hub relative to the casing when engaged therewith.
In certain embodiments, the recess may include a stop that limits the axial extent to which the protrusion may be received in the recess. This may further improve the accuracy with which the needle hub may be assembled in the casing in the desired orientation.
In certain embodiments, the needle hub may be affixed to the casing, e.g. with an adhesive. These embodiments reduce any risk of undesirable movement of the needle hub relative to the casing following assembly.
In certain embodiments, the medicament delivery device may further comprise a cover that is engageable with the housing, wherein the cover may be moveable between a closed configuration in which the volume cannot be accessed, and an open configuration in which the volume can be accessed. The cover may be opened to permit insertion of a rupturable container in the volume, and closed following insertion of the rupturable container. The cover may subsequently be opened to remove an empty rupturable container once the contents thereof have been dispensed.
In certain embodiments, the cover may be manipulated by a user to cause a rupturable container received in the volume to move relative to the needle such that the needle may rupture the rupturable container. For example, the cover may be pressed so as to deform or otherwise move the rupturable container towards the needle so that it may be ruptured. Such embodiments offer a convenient means for actuating the medicament delivery device to deliver a dose of medicament to the user.
In certain embodiments, each of the needle and the needle hub comprise a bore such that medicament and propellant may pass therethrough and out of the medicament delivery device when the rupturable container is ruptured by the needle. The bore of the needle hub may have an internal diameter that increases in a direction out of the medicament delivery device. The increasing diameter of the bore facilitates the formation of a conic-shaped plume of medicament and propellant as it exits the medicament delivery device.
In certain embodiments, the casing comprises a plurality of guide ribs that guide at least a portion of the rupturable container towards the needle when a force is applied to the rupturable container. The guide ribs may improve the reliability of the medicament delivery device and/or improve the user experience when actuating the medicament delivery device.
In certain embodiments, the medicament delivery device may comprise a rupturable container received in the volume, wherein the rupturable container contains a medicament and a propellant. In certain embodiments, the propellant may be a gas or a liquid. In certain embodiments, the propellant may comprise one or more of: air, nitrogen, water, carbon dioxide, butane, hydrofluorocarbon (HFC), or hydrofluoroalkane (HFA).
In another aspect of the present invention, there is provided a method of assembling a medicament delivery device comprising the steps:
Embodiments of the invention are further described hereinafter with reference to the accompanying drawings, in which:
The needle 16 is hollow by virtue of a needle bore 17 that extends along the longitudinal axis 100 through the needle 16 between a first end 16a and a second end 16b of the needle 16. The second end 16b of the needle 16 is attached to the first open end 30a of the through bore 30, as is described further below. Since the needle 16 is hollow, the assembled needle hub assembly 12 defines a continuous fluidic channel through the needle bore 17 and the through bore 30. The needle bore 17 and the through bore 30 pass through the boss 36 so as to provide a fluidic pathway from the volume 40 out of the medicament delivery device 10. The through bore 30 has a tapered profile such that its internal diameter increases along the longitudinal axis 100 in a direction towards the second open end 30b (i.e. along a direction out of the medicament delivery device 10).
The first end 16a of the needle 16 is beveled such that it includes a pointed tip. The beveled first end 16a is capable of rupturing a rupturable container disposed in the volume 40.
When assembled, the needle 16 extends into the through bore 30 through the first open end 30a. An internal shoulder 31 in the through bore 30 (see
A cover (not shown) may connect to the casing 18 and be moveable between a closed configuration and an open configuration so as to permit access to the volume (e.g. for inserting or removing the rupturable container). For example, the cover may be pivotally attached to a pair of pivot holes 44 and, in a closed configuration, may releasably engage with latches 46, where the latches 46 may be overcome by manual manipulation of the cover towards the open configuration or by pressing or squeezing the cover and/or the casing 18 to release the latches 46.
In use, the rupturable container is moved towards the needle 16 so that the beveled first end 16a of the needle 16 contacts and ruptures the rupturable container. As a result, the propellant within the rupturable container vaporises and/or rapidly expands thereby creating a flow of propellant and medicament entrained therein through the needle bore 17 and the through bore 30 out of the medicament delivery device 10. Due to the tapered internal profile of the through bore 30, the released propellant and medicament form a conic-shaped plume as they exit the medicament delivery device 10. The plume may facilitate the spreading of the dose of medicament over a large surface area (e.g. the lining of the nasal cavity) so as to maximise absorption of the medicament by the user. The medicament delivery device 10 may be shaped or otherwise configured so that the exiting medicament may travel into any suitable cavity of the user's body, including but not limited to the nose and the mouth.
The rupturable container may be moved relative to the needle 16 by any suitable means. In certain preferable embodiments, the rupturable container is made of a pliable material and, upon actuation of the medicament delivery device, is caused to deform so as to contact the needle 16. For example, a part of the cover (or another component of the medicament delivery device 10) may be manipulated (e.g. deformed) so that it urges against the rupturable container and at least part of the rupturable container is consequently urged towards the needle 16.
In the non-limiting embodiment shown in the Figures, the casing 18 is provided with a plurality of guide ribs 42 in the volume 40. The guide ribs 42 each have a height that reduces along a direction towards the assembled needle 16. In use, the rupturable container is received in the volume 40 so that it rests on the guide ribs 42. When a force is applied to the rupturable container by a user (e.g. it is compressed by deformation of a cover as described above), at least a portion of the rupturable container is guided by the profile of the guide ribs 42 towards the needle 16 so as to ensure that the needle 16 ruptures the rupturable container.
The needle hub 14 is described in further detail below with reference to
The axially extending rib 32 provides a radially outwardly extending protrusion that defines a non-circular radially outer surface in cross section of the needle hub 14. During assembly, the axially extending rib 32 is received in a recess in the form of an axial slot 38 (shown in
In alternative embodiments, the needle hub 14 may have any alternative profile, external or otherwise, such that circumferential interference between the needle hub 14 and the casing 18 prevents rotation of the needle hub 14 relative to the casing 18 about an axis parallel to the longitudinal axis 100 when the needle hub 14 is engaged with the casing 18. For example, the needle hub 14 may have any non-circular external profile (in cross-section) and may be received in a complementary recess defined in the casing 18. In some embodiments, the needle hub 14 may form a female connector part that has a non-circular internal profile, and that may receive a complementary male connector part (albeit that is hollow) of the casing 18.
Examples of such alternative embodiments are described below with reference to
In alternative embodiments, the mounting portion may have any non-circular radially outer or inner surface cross section that is receivable inside/over a boss having a complementary inner/outer profile. In certain embodiments, the non-circular radially outer or inner surface cross section may be polygonal, including but not limited to square or rectangular. In certain embodiments, one of the mounting portion or the boss may comprise an axial rib or other protrusion whilst the other may comprise a complementary slot or recess. In certain embodiments, the needle hub may only be engageable with the boss in a single relative rotational orientation. As noted above, in other embodiments, the needle hub may be engageable with the boss in more than one relative rotational orientation. In certain embodiments, reference indicia may be provided for assisting the assembler with assembly, so that the needle hub (and hence needle) are orientated in the desired orientation relative to the boss and casing.
As described above, in certain embodiments, means for ensuring or guiding correct rotational alignment of the needle hub 14 relative to the casing 18 may be provided. In the above-described non-limiting embodiment, such means are provided by the axially extending rib 32 (forming a radially extending protrusion) and the axial slot 38 since only one relative rotational orientation is permitted when the needle hub 14 is received by the casing 18.
In alternative embodiments, any similar key and keyhole-like arrangement may be employed to achieve correct or desired rotational alignment. In general, one of the needle hub 14 and the casing 18 may include a protrusion that extends radially relative to the longitudinal axis 100, and the other of the needle hub 14 and the casing 18 includes a recess for receiving the protrusion when the needle hub 14 is engaged with the casing 18, wherein circumferential interference between the protrusion and the recess prevents rotation of the needle hub 14 relative to the casing 18 about an axis parallel to the longitudinal axis 100. In certain embodiments, the recess may comprise a stop that limits the extent to which the protrusion may be inserted into the recess. Thus, the position of the needle hub 14 relative to the casing 18 may be inhibited along a further direction, thereby further ensuring that the needle hub 14 (and hence needle 16) is in the desired configuration relative to the casing 18 (and the rupturable container that may be received therein).
In certain embodiments, multiple rotational alignments of the needle hub 14 relative to the casing 18 may be possible (e.g. if the needle hub 14 has a square cross-section and is received in a complementary recess in the casing 18), and reference indicia (e.g. visual or tactile alignment markers) may be provided to facilitate correct or desired rotational alignment during assembly of the needle hub 14 in the casing 18.
In certain embodiments the propellant may be any sufficiently mobile fluid that may agitate the medicament (e.g. if in a particulate state) into turbulent flow. The propellant is further preferably stable during storage and inert to the medicament and the delivery site. In certain embodiments, the propellant may be a gas or a liquid. Non-limiting examples of propellants that may be used in certain embodiments of the present invention include air, nitrogen, water, or conventional optionally fluorinated lower hydrocarbon propellants such as hydrofluorocarbon (HFC), carbon dioxide, butane, hydrofluoroalkane (HFA) propellants or any compatible combination thereof.
Throughout the description and claims of this specification the term radial internal profile or radially inner surface refers to a surface that faces radially inwardly. Similarly, the term radial external profile or radially outer surface refers to a surface that faces radially outwardly.
Throughout the description and claims of this specification, the words “comprise” and “contain” and variations of them mean “including but not limited to”, and they are not intended to (and do not) exclude other moieties, additives, components, integers or steps. Throughout the description and claims of this specification, the singular encompasses the plural unless the context otherwise requires. In particular, where the indefinite article is used, the specification is to be understood as contemplating plurality as well as singularity, unless the context requires otherwise.
Features, integers, characteristics, compounds, chemical moieties or groups described in conjunction with a particular aspect, embodiment or example of the invention are to be understood to be applicable to any other aspect, embodiment or example described herein unless incompatible therewith. All of the features disclosed in this specification (including any accompanying claims, abstract and drawings), and/or all of the steps of any method or process so disclosed, may be combined in any combination, except combinations where at least some of such features and/or steps are mutually exclusive. The invention is not restricted to the details of any foregoing embodiments. The invention extends to any novel one, or any novel combination, of the features disclosed in this specification (including any accompanying claims, abstract and drawings), or to any novel one, or any novel combination, of the steps of any method or process so disclosed.
The reader's attention is directed to all papers and documents which are filed concurrently with or previous to this specification in connection with this application and which are open to public inspection with this specification, and the contents of all such papers and documents are incorporated herein by reference.
| Number | Date | Country | Kind |
|---|---|---|---|
| 2117043.6 | Nov 2021 | GB | national |
| Filing Document | Filing Date | Country | Kind |
|---|---|---|---|
| PCT/GB2022/052988 | 11/25/2022 | WO |
