The invention concerns medicament delivery member housing assemblies, and particularly medicament delivery member housing assemblies with shields protecting the medicament delivery member.
In cartridge-based medicament delivery devices such as autoinjectors, it is important that the medicament delivery member (e.g. a needle) is kept safe before use, both to avoid needle stick injuries and also to maintain sterility. In addition, cartridge-based medicament delivery devices are typically provided with the medicament delivery member separated from the medicament container, which means that the user typically has to somehow attach the medicament delivery member to the medicament container before carrying out an injection. This adds extra steps and therefore extra complexity to device usage, which is undesirable in terms of ease of use. Considering this, the applicant has appreciated that improvements can be made in comparison to existing designs.
The invention is defined by the appended claims, to which reference should now be made.
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 terms “longitudinal”, “longitudinally”, “axially” and “axial” refer to a direction extending from the proximal end to the distal end and along the device or components thereof, typically in the direction of the longest extension of the device and/or component.
Similarly, the terms “transverse”, “transversal” and “transversally” refer to a direction generally perpendicular to the longitudinal direction.
An aspect of the invention concerns a medicament delivery member housing assembly extending along an axis in a longitudinal direction from a proximal end to a distal end, the medicament delivery member housing assembly comprising: a housing comprising a body and a flexible arm, the flexible arm extending in the longitudinal direction from a proximal end moveable relative to the body to a distal end attached to the body, wherein the flexible arm comprises a first surface facing towards the proximal end of the medicament delivery member housing assembly and a second surface facing in a radial direction relative to the axis; a medicament delivery member; a proximal shield extending around a first end of the medicament delivery member, the proximal shield comprising a surface facing towards the distal end of the medicament delivery member housing assembly to interact with the first surface of the housing during use; and a distal shield extending around a distal end of the medicament delivery member, the distal shield being slidable in the longitudinal direction relative to the proximal shield, the distal shield comprising a surface facing in the radial direction to interact with the second surface of the housing during use.
This design can provide a built-in needle-housing assembly for cartridge-based autoinjectors. This design can first connect the distal end of the needle to a cartridge and penetrate the proximal end of the proximal shield and subsequently an injection site with a simple linear compressive motion. As such, it can be implemented into a device activation mechanism (e.g. a needle cover compression), and can thereby avoid the need for any additional user preparation steps.
Preferably, the medicament delivery member housing assembly comprises a needle attached to the housing. Preferably, the proximal end of the medicament delivery member housing assembly is the end of the medicament delivery member housing assembly closest to the site of delivery of a medicament during use. With the housing assembly this way around, a medicament container can be penetrated before a medicament delivery member extends out of the proximal end of the housing assembly.
Preferably, the medicament delivery member housing assembly is configured to move from an initial extended position in which the needle is fully enclosed by the medicament delivery member housing assembly to a final compressed position where the needle extends out of the proximal end of the proximal shield and where the needle extends out of the distal end of the distal shield.
Preferably, the medicament delivery member housing assembly is configured to move from the initial extended position to an intermediate partially-extended position and then to a final compressed position, wherein in the initial extended position, the first surface of the flexible arm and the surface of the proximal shield are aligned in the longitudinal direction, wherein in the intermediate partially-extended position, the first surface of the flexible arm and the surface of the proximal shield are offset from one another in the longitudinal direction and adjacent to one another in the radial direction, and the second surface of the flexible arm is adjacent to the surface of the distal shield, wherein in the final compressed position, the surface of the proximal shield is further from the proximal end of the proximal shield than the first surface of the flexible arm is from the proximal end of the proximal shield.
Preferably, the second surface of the flexible arm faces away from the axis in the radial direction and the surface of the distal shield faces towards the axis in the radial direction. Preferably, the proximal end of the proximal shield comprises a septum which the medicament delivery member can penetrate. Preferably, the distal end of the distal shield comprises a septum which the medicament delivery member can penetrate. This can allow use of different materials for the area being penetrated and for other parts of the shields.
Preferably, the first surface of the flexible arm and the surface of the proximal shield are spaced apart in the longitudinal direction. This can reduce the force needed to initiate movement of the proximal shield relative to the distal shield.
Preferably, the medicament delivery member housing assembly comprises a seal arranged between the proximal shield and the distal shield. Preferably, the seal is attached to only one of the proximal shield and the distal shield. Preferably, the one of the proximal shield and the distal shield that the seal is not attached to comprises a recess, and the seal extends into the recess.
Preferably, the one of the proximal shield and the distal shield that the seal is not attached to comprises a protrusion extending in the radial direction, and the seal abuts the protrusion. This can allow the seal to be spaced apart from the outer surface of the one of the proximal shield and the distal shield that the seal is not attached to, which can reduce friction during use (as the seal does not rub against the one of the proximal shield and the distal shield that the seal is not attached to as the proximal shield moves relative to the distal shield)
Preferably, the proximal end of the flexible arm is moveable relative to the body in a radial direction relative to the axis. Preferably, the proximal shield is tubular and the distal shield is tubular, and the diameter of the distal shield is wider than the diameter of the proximal shield, in the direction perpendicular to the longitudinal axis. Preferably, the housing is attached to the distal shield by a snap fit and/or the distal shield is attached to the proximal shield by a snap fit. Preferably, the distal shield has a greater radius when measured perpendicular to the axis than the proximal shield.
Another aspect concerns a cassette comprising a medicament delivery member housing assembly as described above. Preferably, the medicament delivery member housing assembly is attached to the cassette by a snap-fit.
Another aspect concerns an autoinjector comprising a medicament delivery member housing assembly as described above or comprising a cassette as described above.
Another aspect concerns a method of operating a medicament delivery member housing assembly, comprising the steps of: pushing a proximal shield of the medicament delivery member housing assembly in the distal direction relative to a distal shield of the medicament delivery member housing assembly, so that a body of the medicament delivery member housing assembly is also pushed in the distal direction relative to the distal shield by the interaction between a surface of the proximal shield and a first surface of the body until a distal end of a medicament delivery member of the body penetrates a distal end of the distal shield, then pushing the proximal shield further in the distal direction relative to the distal shield and also relative to the body, until a proximal end of the medicament delivery member penetrates a proximal end of the proximal 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, member, component, means, etc. are to be interpreted openly as referring to at least one instance of the element, apparatus, member component, means, etc., unless explicitly stated otherwise.
Embodiments of the invention will now be described by way of example only and with reference to the accompanying drawings, in which:
The housing 20, which is shown in more detail in
The housing 20 also comprises an optional pair of flanges 25 at the proximal end of the housing. When the needle-housing assembly is assembled, the flanges 25 do not overlap with the arms 48 of the optional shield in the circumferential direction 17, but the flanges 25 do overlap with the arms 48 in the axial direction. This can help with assembly, and can also help ensure that the body and the proximal shield cannot rotate relative to each other (which could otherwise result in the surface of the proximal shield and the first surface of the body moving out of alignment with one another).
As can be seen from
The distal shield 60, which is shown in more detail in
As can be seen from
As can be seen in
Optionally, the distal arm 77 extends from a flange 76 at the distal end of the distal shield 60. The protrusion 78 may alternatively be arranged directly on the distal shield 60, in which case the distal arm 77 and the flange 76 may be optional.
The needle-housing assembly includes two cavities 44, 64 that generally fully enclose the needle. The first cavity (the cavity 44 of the proximal shield 40) is primarily formed by the proximal shield 40 (specifically the proximal wall 46 and the outer tubular portion 47), with enclosure of the cavity being completed by the proximal end of the distal shield 60 and the body 22, along with the optional seal 80 between the proximal shield and the distal shield. The second cavity (the cavity 64 of the distal shield 60) is primarily formed by the distal shield 60 (specifically the inner tubular portion of the distal shield), with enclosure of the cavity being completed by the body 22. The two cavities 44, 64 are not necessarily isolated from one another, as can be seen in
The mechanism behind this sequence will now be explained. Once the needle-housing assembly starts to be compressed by pushing the proximal shield and the distal shield towards each other (for example when an autoinjector is pressed against an injection site), the first surface 26 of the housing engages the surface 42 of the proximal shield (overcoming the resistance from any connection between the distal shield and the body, such as the recesses 29 and corresponding arms 72 of the distal shield). As a result, the proximal shield and the body move in the distal direction relative to the distal shield. As this happens, the second surface 28 of the housing engages the surface of the distal shield, with the result that the first surface 26 of the housing is moved out of alignment with the surface 42 of the proximal shield (intermediate position). Once the first surface 26 of the housing is offset from (moved out of alignment with) the surface 42 of the proximal shield in the longitudinal direction, the proximal shield can continue to move in the distal direction relative to the distal shield, and now also moves in the distal direction relative to the body to reach a final position.
The examples described above include a needle, and the medicament delivery member housing assembly is therefore described as a needle housing assembly. However, in general any medicament delivery member could be used; for example, a jet injector instead of a needle. In some cases, the medicament delivery member and/or the body comprises a piercing portion such as a spike, a ring or a needle to pierce the septums at the proximal end and/or at the distal end, particularly if one or both ends of the medicament delivery member is blunt.
In the examples above, the needle pierces the septum 70 of the distal shield first, and then subsequently pierces the septum 50 of the proximal shield. This means that in a complete device, where the proximal end is the end located closest to the medicament delivery site during device use, the needle first pierces the medicament cartridge and then extends out of the proximal end of the device. This is because the proximal shield first pushes the body and then disengages with the body once the distal shield engages the flexible arms of the body. However, the opposite orientation within a completed device is also possible, in which case the distal shield would actually be closer to the proximal end (i.e. the end closest to the medicament delivery site during device use) of the medicament delivery device than the proximal shield.
A needle housing with a particular shape is shown in the examples described above, but various modifications can be made to this shape. For example, the first surface 26 of the housing and the surface 42 of the proximal shield are shown as spaced apart in the longitudinal direction, but are alternatively not spaced apart in the longitudinal direction. The arms 24 could be extended further in the proximal direction (and the corresponding arms 48 of the proximal shield shortened or removed). The first surface 26 of the housing is shown at the proximal-most end of the flexible arm 24 of the housing, but could also be in a more distal position on the arm 24. The body 22 of the housing is shown as tubular, but could alternatively be less substantial; for example, the body could just be a ring.
The flexible arms 24 of the housing are shown being pushed inwards towards the axis so that the arms can pass into the distal shield in the examples given above. Alternatively, though, the arms 24 could be flexed so that they move in a different direction, for example circumferentially, to pass the restriction of the distal shield. In another alternative, the arms could be flexed outwards rather than inwards. The second surface 28 of the housing is shown as an integral part of the arm 24, but could alternatively be an extra feature such as a protrusion extending from the arm 24.
Two arms 24 are shown, but one, three or more arms could alternatively be provided. The same goes for many other features within the designs described herein, including the flanges 25 of the housing, the arms 72 of the distal shield and the distal arms 77 of the distal shield. Other features such as the ribs 45 of the proximal shield and the protrusions 65 of the distal shield can also be provided in quantities different to those shown in the examples.
The needle 30 is described above as a single needle. The needle could, however, comprise a proximal needle and a distal needle, with a channel through the body leading from the proximal needle to the distal needle. In the examples above, both ends of the needle have optional bevelled ends, which can help with penetration of the septums 50, 70.
Various alternatives are also possible for the shape of the proximal shield 40 and its constituent features. Typically, the proximal shield extends around a first end of the medicament delivery member. Providing arms 48 extending in the axial direction is optional, and the arms could extend in the radial direction instead. Alternatively, the use of arms could be avoided altogether by providing the surface 42 on a different part of the proximal shield. In general, the surface 42 of the proximal shield faces towards the distal end of the medicament delivery member housing assembly to interact with the first surface of the housing during use. The outer tubular portion 47 could instead be conical.
An optional extra feature is visible in
The sealed proximal cavity 44 could just be between the housing and the proximal shield (rather than being formed by the housing, the proximal shield and the distal shield as described above), though this would need a different structure for the housing arms (e.g. with webbing between the arms). In general, providing sealed cavities for the medicament delivery member are not essential from a technical point of view (the medicament delivery member can still be protected without sealing), but are typically included to provide the added benefit of full sterility around the needle.
The septum 50 of the proximal shield is optional, and it may instead be an integral part of the proximal shield which is penetrated. The same goes for the septum 70 of the distal shield. The septums 50, 70 may be softer than the parts of the proximal shield and the distal shield respectively that they are attached to. One or both septums could be at the extreme end of the shield (as is the case for the septum 50 in
As with the proximal shield, various alternatives are possible for the shape of the distal shield 60, and some examples will now be given. The distal shield typically extends around a distal end of the medicament delivery member. In general, the surface 62 of the distal shield faces in the radial direction to interact with the second surface of the housing during use. The inner tubular portion 68 is optional; instead of being attached to the inner tubular portion 68, the arms 72 could be attached to other parts of the distal shield 60, such as to the outer tubular portion 67.
The flange 76 of the distal shield is optional. The flange 76 can be beneficial to limit the distal traverse available to the proximal shield (this could alternatively or additionally be limited by the proximal wall of the proximal shield and/or by another needle-housing component or by another cassette component) and/or to attach the needle-housing assembly within a medicament delivery device.
Provision of a seal 80 is optional, but is typically beneficial to help maintain sterility inside the needle-housing assembly. In general, a number of possible solutions are available to seal the gap between the proximal shield 40 and the distal shield 60. A number of possible solutions are also available to attach the proximal shield and the distal shield together, some of which include the seal 80. A number of examples are outlined below. In all these examples, the proximal shield and distal shield could be switched around.
For example, one approach simply uses a tight fit between the proximal shield and the distal shield, resulting in the proximal shield and the distal shield being held together by friction. Including an optional seal 80 in such an embodiment can help increase the friction. A second approach uses a snap fit, for example as shown in
A third approach uses the seal 80 itself to hold the proximal shield and the distal shield together, by friction and/or with help from the structure of the proximal shield and/or the distal shield. For example, by attaching the seal 80 to one of the proximal shield and the distal shield, providing a recess 49 in the other of the proximal shield and the distal shield, and having the seal extend into the recess to restrict longitudinal movement of the proximal shield relative to the distal shield. The seal is typically flexible and can be pushed out of the way during use of the needle-housing assembly, allowing the proximal shield to move in the distal direction relative to the distal shield, although one or both of the proximal shield and the distal shield could instead be flexible. This approach can be seen in
Several specific examples of combinations of approaches are shown herein. The first is shown in
Another combination of approaches is shown in
The example shown in
Various modifications to the embodiments described are possible and will occur to those skilled in the art without departing from the invention which is defined by the following claims.
Number | Date | Country | Kind |
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20214486.1 | Dec 2020 | EP | regional |
Filing Document | Filing Date | Country | Kind |
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PCT/EP2021/084186 | 12/3/2021 | WO |