A SUB-ASSEMBLY FOR A MEDICAMENT DELIVERY DEVICE
20240001034 ยท 2024-01-04
Inventors
Cpc classification
International classification
Abstract
A sub-assembly for a medicament delivery device, the sub-assembly having a housing extending along a longitudinal axis from a proximal end to a distal end; a cap releasably attached to the proximal end of the housing; wherein one of the cap and the housing has a user-visible surface extending in a circumferential direction relative to the axis, the surface having a cut-out; wherein the other one of the cap and the housing has a protrusion in the cut-out; and wherein the cut-out defines a user-visible labyrinth which the protrusion must follow during use in order for the cap to be detached from the housing.
Claims
1-15. (canceled)
16: A sub-assembly for a medicament delivery device, the sub-assembly comprising: a housing extending along a longitudinal axis from a proximal end to a distal end; a cap releasably attached to the proximal end of the housing; wherein one of the cap and the housing comprises a user-visible surface extending in a circumferential direction relative to the axis, the surface comprising a cut-out; wherein the other one of the cap and the housing comprises a protrusion in the cut-out; and wherein the cut-out defines a user-visible labyrinth which the protrusion must follow during use in order for the cap to be detached from the housing.
17: The sub-assembly for a medicament delivery device as claimed in claim 16, wherein the labyrinth comprises a first longitudinal portion extending along the longitudinal axis between a first end and a second end; and wherein the protrusion is axially movable relative to the user-visible surface between the first end of the first longitudinal portion and the second end of the first longitudinal portion.
18: The sub-assembly for a medicament delivery device as claim 17, wherein the labyrinth comprises a first circumferential portion extending around the longitudinal axis between a first end and a second end; and wherein the protrusion is circumferentially movable relative to the user-visible surface between the first end of the first circumferential portion and the second end of the first circumferential portion.
19: The sub-assembly for a medicament delivery device as claimed claim 16, wherein the labyrinth comprises a helical portion extending in a direction parallel to the longitudinal axis and in a direction around the longitudinal axis between a first end and a second end; and wherein the protrusion is movable relative to the user-visible surface between the first end of the helical portion and the second end of the helical portion.
20: The sub-assembly for a medicament delivery device as claimed in claim 18, wherein the labyrinth comprises a second longitudinal portion extending along the longitudinal axis between a first end and a second end; and wherein the protrusion is axially movable relative to the user-visible surface between the first end of the second longitudinal portion and the second end of the second longitudinal portion.
21: The sub-assembly for a medicament delivery device as claimed in claim 20, wherein the labyrinth comprises a second circumferential portion extending around the longitudinal axis between a first end and a second end; and wherein the protrusion is circumferentially movable relative to the user-visible surface between the first end of the second circumferential portion and the second end of the second circumferential portion.
22: The sub-assembly for a medicament delivery device as claimed claim 20, wherein the sub-assembly comprises a bump extending from an edge of the cut-out of the user-visible surface into the labyrinth.
23: The sub-assembly for a medicament delivery device as claimed in claim 22, wherein the bump extends in the direction of the longitudinal axis into the second circumferential portion of the labyrinth.
24: The sub-assembly for a medicament delivery device as claimed in claim 16, wherein the cap comprises an enclosing body defining an interior area; wherein the housing comprises a proximal portion arranged within the interior area of the enclosing body when the cap is attached to the proximal end of the housing; and wherein the user-visible surface is a part of an external surface of the enclosing body of the cap; and wherein the protrusion is protruding away from the proximal portion of the housing relative to the longitudinal axis.
25: The sub-assembly for a medicament delivery device as claimed claim 16, wherein the housing comprises an enclosing portion on the proximal end of the housing; wherein the cap comprises a distal portion enclosed by the enclosing portion of the housing when the cap is attached on the proximal end of the housing; and wherein the user-visible surface is a part of an external surface of the enclosing portion of the housing, and the protrusion is outwardly protruding away from the distal portion of the cap relative to the longitudinal axis.
26: A medicament delivery device comprising a sub-assembly according to claim 16.
27: The medicament delivery device according to claim 26, comprising a needle assembly; wherein the needle assembly comprises a needle and a needle cap at least partially enclosing the needle; and wherein the needle cap is attached to the cap.
28: The medicament delivery device according to claim 27, comprising a needle holder attached to the needle and a connector; wherein the needle cap comprises a rib partially situated within a cut-out of the needle holder and partially engaged with a proximally directed surface of the needle holder; wherein the connector comprises a slot; and wherein the needle holder comprises a rib.
29: The medicament delivery device of claim 26, wherein the medicament delivery device is an auto-injector.
30: A method of operating a medicament delivery device according to claim 26, the method comprising the following steps with the following order: rotating the cap relative to the housing around the longitudinal axis; pushing the cap relative to the housing towards the distal direction of the housing in the direction of the longitudinal axis; rotating the cap relative to the housing around the longitudinal axis; pulling the enclosing body of the cap relative to the housing towards the proximal direction of the housing in the direction of the longitudinal axis.
31: A sub-assembly for a medicament delivery device, the sub-assembly comprising: a housing extending along a longitudinal axis from a proximal end to a distal end; and a cap releasably attached to the proximal end of the housing; wherein one of the cap and the housing comprises a user-visible surface extending in a circumferential direction relative to the axis, the surface comprising a cut-out, wherein the other one of the cap and the housing comprises a protrusion in the cut-out, and wherein the cut-out defines a user-visible labyrinth which the protrusion must follow during use in order for the cap to be detached from the housing.
32: The sub-assembly of claim 31, wherein the labyrinth comprises two circumferential portions and a longitudinal portion.
33: The sub-assembly of claim 32, wherein the protrusion is axially movable relative to the user-visible surface during movement within the circumferential portions and the longitudinal portion.
34: The sub-assembly of claim 32, wherein the sub-assembly comprises a bump extending from an edge of the cut-out of the user-visible surface into the labyrinth, where the bump extends into one of the circumferential portions of the labyrinth.
35: The sub-assembly of claim 31, wherein the cap comprises an enclosing body and the housing comprises a proximal portion arranged within an interior area of the enclosing body when the cap is attached to the proximal end of the housing, where the user-visible surface is a part of an external surface of the enclosing body of the cap and where the protrusion radially protrudes from an outer surface of the proximal portion of the housing.
Description
BRIEF DESCRIPTION OF THE DRAWINGS
[0046] Embodiments of the presently disclosed concept will now be described, by way of example only, with reference to the accompanying drawings, in which:
[0047]
[0048]
[0049]
[0050]
[0051]
DETAILED DESCRIPTION
[0052]
[0053] As shown in
[0054] The sub-assembly can be an integral part of a medicament delivery device. In this example, the housing 1 is configured to accommodate a medicament container; and the cap 2 is acting as the front cover of the medicament delivery device. The cap 2, in this example is configured to at least partially receive a medicament delivery member that is configured to be attached to the accommodated medicament container while the cap 2 is being removed from the proximal end of the housing 1.
[0055] On the other hand, the sub-assembly may be an add-on device for being loaded onto a medicament delivery device. For example, the housing may comprise a distal opening configured to be loaded with a medicament delivery device. The medicament delivery device can be placed into the interior cavity of the housing; or the housing may be formed by two half shells parallel to the longitudinal axis L; the two half shells may be pivotally connected to each other, so that the housing can be pivotally opened and load a medicament delivery device within the interior cavity of the housing. In this example, the cap is configured to be fixed to a front cover of the loaded medicament delivery device, for example, by a connection between a press-fit feature arranged on an inner surface of the generally tubular shaped portion of the cap and the front cover of the loaded medicament delivery device; or a form-fit connection between the interior cavity of the cap and the front cover of the loaded medicament delivery device. In this example, a medicament delivery device can be loaded into the sub-assembly by a care provider, e.g. a doctor, nurse, pharmacist, other caregiver or a medicament delivery device distributor, such as the medicament delivery device distributor, can have the medicament delivery devices loaded before putting the medicament delivery devices into final packages.
[0056] The sub-assembly can be used in a medicament delivery device, for example, an auto-injector, a hand-held auto-injector (i.e. the user needs to directly or indirectly, e.g. using an assisting pad to hold, hold the auto-injector during the medicament delivery operation), a pen injector, an inhalation device or a medical sprayer.
[0057] One of the cap 2 of the sub-assembly and the housing 1 of the sub-assembly comprises a user-visible surface, the user-visible surface is a surface that is able to be seen by the user from an outside of the sub-assembly when the sub-assembly is assembled to a medicament delivery device. The user-visible surface extends in a circumferential direction relative to the axis, the user-visible surface comprises a cut-out radially arranged relative to the longitudinal axis L; and the other one of the cap 2 of the sub-assembly and the housing 1 of the sub-assembly comprises a protrusion in the cut-out, so that the user is able to see both the cut-out and the protrusion on the user-visible surface directly from the outside of the sub-assembly. The cut-out defines a user-visible labyrinth which the protrusion must follow during use in order for the cap 2 to be detached from the housing 1.
[0058] When the protrusion is in the cut-out, the cap 2 cannot be detached from the housing 1 because a moving distance, both along the longitudinal axis and around the longitudinal axis, between the cap 2 and the housing 1 is limited by the labyrinth and the protrusion. Only if the protrusion follows the labyrinth, and finally being moved out from the labyrinth, can the cap 2 be completely detached from the housing 1.
[0059] In one embodiment, the cap 2 comprises the cut-out with the labyrinth 21; and the housing 1 comprises the protrusion 11, as shown in
[0060] In this embodiment, the cap 2 comprises an enclosing body 20 defining an interior area, the user-visible surface is a part of an external surface of the enclosing body 20, and the housing 1 comprises a proximal portion 10 arranged within the interior area of the enclosing body 20 when the cap 2 is attached to the proximal end of the housing 1. The protrusion 11 is protrudes outwardly relative to the longitudinal axis L from the proximal portion 10 of the housing 1.
[0061] The labyrinth 21 comprises an exit portion 22, so if the protrusion 11 is moved, following along the labyrinth 21, and finally arrives at the exit portion 22, the cap 2 can be detached from the housing 1.
[0062] In one example, the cap may comprise multiple cut-outs forming labyrinths on the enclosing body rather than a single cut-out; the labyrinths formed by each cut-out are symmetrical relative to one another; for example, the cap may comprise two symmetrically arranged cut-outs forming labyrinths on the enclosing body. In this example, the housing comprises two symmetrical protrusions for matching with the labyrinths. In this example, a force that the user applies to the cap can be evenly distributed on the protrusions and the labyrinths, so that the even if the user is not following the labyrinths and tries to remove the cap from the housing, for example, simply pulling the cap hard relative to the housing, the labyrinths will not be bent since the force is evenly distributed on the protrusions and the labyrinths.
[0063] It should be noted that the arrangement of the multiple symmetrically arranged cut-outs with labyrinth and the protrusions is also applied if the housing comprises the cut-outs with labyrinth and the cap comprises the protrusions or a mix of both.
[0064] In one embodiment, as shown in
[0065] In another example, the exit portion of the labyrinth is formed by a flexible wall extending at least partially from an edge of the cut-out. For example, the enclosing body 20 of the cap 2 can be formed in more than one material, and the material around the exit portion may be a resilient material, e.g. rubber or silicone. Alternatively, the enclosing body 20 of the cap 2 may be formed of a single material, e.g. plastic, but a thickness (measured along the transverse direction relative to the longitudinal axis L) of the wall is less than a thickness (measured along the transverse direction relative to the longitudinal axis L) of other parts of the enclosing body 20 of the cap 2 around the labyrinth.
[0066] The wall of the labyrinth is configured to be deflected radially outward relative to the longitudinal axis L by the protrusion 11 when the protrusion 11 axially moves past, so that the protrusion 11 will then leave the labyrinth once the protrusion 11 passes the exit portion. In a preferred example, the protrusion 11 comprises a distally directed ramp surface, and the flexible wall that forms the exit portion comprises a proximally directed ramp surface, so that when the distally directed ramp surface of the protrusion 11 contacts with the proximally directed ramp surface, the flexible wall may be more easily deflected radially outward.
[0067] Furthermore, the flexible wall that forms the exit portion in this example may comprise one or more slots, so that the flexible wall can be more flexible due to the material reduction, and therefore reduce the material tensile force at the same time.
[0068] In another embodiment, the exit portion 22 of the labyrinth 21 is a ruptured portion of the cut-out, meaning that at the exit portion 22 of the labyrinth 21, there is no more a wall from the cut-out blocking the longitudinal movement of the protrusion 11, so that the protrusion 11 is able to leave the labyrinth 21 once the protrusion 11 is moved past the exit portion 22 of the labyrinth 21, as shown in
[0069] In another embodiment, the exit portion of the labyrinth is a portion of the cut-out that can rupture (for example a breakable wall or seal extending across the exit portion), meaning that at the exit portion of the labyrinth, that the protrusion is able to leave the labyrinth through the portion of the cut-out that can rupture. In this example, the breakable wall/seal can be a tamper-evident seal to indicate whether the medicament delivery device is used or is no longer in a sterilized situation.
[0070] The exit portion is preferably located on an edge of the cap 2 or the housing 1. In the embodiment shown in
[0071] It should be noted that, alternatively, the cut-out (and also the labyrinth) can be arranged on the housing 1, and the protrusion can be arranged on the cap. For example, the housing may comprise an enclosing portion on the proximal end of the housing; and the cap comprises a distal portion enclosed by the enclosing portion of the housing when the cap is attached on the proximal end of the housing. In this example, the user-visible surface is a part of an external surface of the enclosing portion of the housing, and the protrusion is outwardly protruding from the distal portion of the cap. In this example, the exit portion is preferably arranged on a proximal end edge of the housing.
[0072] The labyrinth 21 may comprise one or more longitudinal portions, one or more circumferential portions, and/or one or more helical portions. The connection between the one or more longitudinal portions and/or the one or more circumferential portions and/or the one or more helical portions is dependent on the design of the medicament delivery device that will be loaded into.
[0073] For example, WO 2009150078 discloses a medicament delivery device with a preassembled medicament delivery member that can be attached to a contained medicament container through a bayonet connection or a thread connection between a medicament delivery member holder and a medicament container adaptor. However, the user needs to manipulate the cap along a path for the bayonet connection or the thread connection, so that the when the end user removes the cap, the medicament delivery device can be also attached to the contained medicament container.
[0074] In examples where the user needs to attach the preassembled medicament delivery member to the contained medicament container through a bayonet connection together with the movement of the cap removal, the labyrinth 21 should comprise a first longitudinal portion 21a extending along the longitudinal axis L between a first end and a second end. The labyrinth 21 comprises a first circumferential portion 21b extending around the longitudinal axis L between a first end and a second end. The second end of the first longitudinal portion 21a is connected to the first end of the circumferential portion 21b. The exit portion of the cut-out is located at the second end of the circumferential portion. In such an embodiment, the longitudinal extent of the cap 20 varies at different points around the cap. During assembly on a production line, the protrusion 11 should be initially positioned at the first end of the first longitudinal portion 21a of the labyrinth 21, similar to the position shown in
[0075] In this example, to detach the cap from the housing, the user can only move the cap and the housing longitudinally relative to each other first, then can only move the cap and the housing circumferentially relative to each other, shown in
[0076] Alternatively, instead of locating the exit portion at the second end of the first circumferential portion 21b of the labyrinth, the labyrinth comprises a second longitudinal portion 21c extending along the longitudinal axis L between a first end and a second end. The first end of the second longitudinal portion 21c is connected to the second end of the first circumferential portion 21b, and the exit portion 22 is located at the second end of the second longitudinal portion 21c. In this example, the protrusion will be guided to move to the edge of the cap or housing, so that the protrusion can leave the labyrinth more easily.
[0077] Furthermore, the labyrinth 21 may comprise a second circumferential portion 21d extending around the longitudinal axis L between a first end and a second end. Instead of assembling the protrusion 11 to be located at the first end of the first longitudinal portion 21a of the labyrinth, the protrusion 11 can be assembled to locate at the first end of the second circumferential portion 21d of the labyrinth 21 during assembly on the production line. The second end of the second circumferential portion 21d of the labyrinth 21 is connected to the first end of the first longitudinal portion 21a of the labyrinth 21, as shown in 4A-4D.
[0078] The first longitudinal portion 21a of the cut-out 21 and the first circumferential portion 21b of the cut-out 21 are configured to guide the user to detach the cap from the housing through the bayonet connection path, so that the medicament delivery member can be attached to the medicament container. The second longitudinal portion 21c of the labyrinth 21 and/or the second circumferential portion 21d of the labyrinth 21 are optional security features. For example, the second circumferential portion 21d of the labyrinth 22 is configured to prevent an unintentional use of the medicament delivery device if the end user accidentally pushes on the cap 2; so that the contained medicament can be retained in a sterilized state until the end user plans to use the medicament delivery device.
[0079] In a preferred example, the sub-assembly of the present disclosure is used in a medicament delivery device that comprises a needle assembly 3, as shown in
[0080] In this example, the needle 32 is attached to the needle holder 32, e.g. by glue. The needle holder 31 comprises a rib 31a protruding from an outer surface of the needle holder 31, a flange section 31b, and a cut-out 31c. The connector 33 comprises a first tubular section 33a for receiving at least a part of the needle holder 31, a second tubular section 33b for receiving a proximal end of the medicament container of the medicament delivery device, and a fastener 33c for attaching the needle assembly 3 to the housing 1 of the medicament delivery device. In a preferred example, the fastener 33c is a snap-fit arm.
[0081] In this example, the connector 33 comprises a slot 33d in a wall of the first tubular section 33a. In a preferred example, the slot 33d opens towards a central axis of the first tubular section 33a. The rib 31a of the needle holder 31 is configured to be situated at a proximal edge of the first tubular section 33a of the connector 33 in an original position. When the user plans to use the medicament delivery device, the needle holder 31 is configured to be rotated by the needle cap 30 (by the engagement between the cut-out 31c of the needle holder 31 and a rib 30c of the needle cap, as shown in
[0082] In this example, the labyrinth 21 the first longitudinal portion 21a, the first circumferential portion 21b, the second longitudinal portion 21c, and the second circumferential portion 21d, as shown in
[0087] The user's behavior of manipulating the cap 2 removal from the housing 1 is not only structurally guided by the labyrinth 21 and the protrusion 11, but also visually guided by the labyrinth 21 and the protrusion 11, since both the cut-out 21 and the protrusion 11 can preferably be observed from the outside of the medicament delivery device. In a preferred example, the protrusion 11 may comprise a bright or eye-catching color, e.g. red, yellow; or a contrasting color relative to the enclosing body 20 of the cap 2 when the labyrinth 21 is arranged on the cap 2; or the housing when the labyrinth is arranged on the housing; so that the user can easily notice the protrusion 11, and easily understand when the cap 2 can be fully detached from the housing 1.
[0088] In another example that the end user needs to attach the preassembled medicament delivery member to the contained medicament container through a thread connection together with a movement of cap removal, the labyrinth should comprise a helical portion longitudinally and circumferentially extending from a first end to a second end. During assembly on a production line, the protrusion should be initially positioned at the first end of the helical portion of the labyrinth. The exit portion is located at the second end of the helical portion of the labyrinth, and only when the end user twists the cap relative to the housing along the helical portion of the labyrinth is the end user able to detach the cap from the housing. As described above, it is also possible in this example to include the second longitudinal portion and/or the second circumferential portion in the labyrinth as one or more security features.
[0089] In another example where the end user needs to attach the preassembled medicament delivery member to the contained medicament container through a snap-fit connection, the user may need to remove the cap from the housing by pushing the cap relative to the housing first, then pulling the cap out from the housing. In this example, the labyrinth may comprise a first longitudinal portion for guiding the end user to push the cap relative to the housing, and a second longitudinal portion for guiding the end user to pull the cap relative to the housing. The first longitudinal portion and the second longitudinal portion are connected through a helical portion, the labyrinth in this example may be therefore formed generally as a V shape on the enclosing body of the cap/or on the enclosing portion of the housing.
[0090] Besides the one or more longitudinal portions, one or more circumferential portions, and/or one or more helical portions of the labyrinth, the sub-assembly may comprise a bump 23 extending from an edge of the cut-out of the user-visible surface into the labyrinth. Preferably, the bump 23 is located in the portion of the labyrinth 21 where the protrusion 11 is located immediately after assembly. For example, if the protrusion 11 is at the first end of the second circumferential portion 21d of the labyrinth 21 after assembly on the production line, then the bump 23 can be located in the second circumferential portion 21d, as shown in
[0091] It should be noted that the one or more longitudinal portions, one or more circumferential portions, and/or one or more helical portions of the labyrinth can be partially formed with another shapes, e.g. arrow shapes. For example, if the front cover of the medicament delivery device can be detached by twisting 180 degree clockwise around the longitudinal axis L relative to the housing, the labyrinth optionally only comprises one circumferential portion extending around be longitudinal axis L between a first end and a second end. The second end may be formed as an arrow shape pointing toward the clockwise direction, and the exit portion may be located at the second end of the circumferential portion.
[0092] It should be noted that example mechanisms for detaching a front cover from a medicament delivery device and attaching a preassembled medicament delivery member to a medicament container in a medicament delivery device by removing the front cover are described in documents such as WO2009/150078 and WO2011/112136, the entire contents of which are incorporated herein by reference.
[0093] The disclosed 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 present disclosed concept, as defined by the appended claims.