INJECTION DEVICE INCORPORATING A NEEDLE SHIELD REMOVER
20230102922 · 2023-03-30
Inventors
Cpc classification
A61M5/20
HUMAN NECESSITIES
International classification
A61M5/20
HUMAN NECESSITIES
Abstract
An injection device (1) comprising a housing (10), a syringe (2) having an injection needle (4) covered by a needle shield (5), and a cap assembly (3) comprising a cap body (15) covering a distal end of the syringe, and a shield remover (9) adapted to engage the needle shield (5), the shield remover (9) being axially fixed relative to the cap body (15). The cap assembly (3) further comprises an elevation member (12) being movable rotationally and axially relative to the cap body (15), wherein the elevation member (12) comprises a first rotation preventing geometry (18, 28, 31) configured to prevent the elevation member (12) from rotating relative to the housing (10), and a cam interface (20) with engaging cam surfaces respectively disposed on the elevation member (12) and the cap body (15), the cam surfaces being configured to engage slidingly upon rotation of the cap body (15) relative to the housing (10) so as to cause a proximal facing surface (17) of the elevation member (12) to be axially forced against a distally facing surface (16) fixedly disposed relative to the housing (10) while moving the cap body (15), the shield remover (9) and the needle shield (5) distally relative to the housing (10).
Claims
1. An injection device for expelling a drug from a syringe, the injection device comprising: a housing formed to be gripped by a subject user, the housing extending along a central longitudinal axis, and defining a distal needle end and an opposite proximal end, syringe retaining means, a syringe comprising a barrel mounted relative to the syringe retaining means, an injection needle, and a needle shield arranged over the injection needle; and a cap assembly comprising a cap body covering a distal end of the syringe, and a shield remover adapted to engage the needle shield, the shield remover being axially fixed relative to the cap body; wherein the injection device defines: a distally facing surface arranged axially fixed relative to the housing, and a shield removal mechanism comprising a cam interface adapted to axially separate the needle shield from the injection needle upon rotation of the cap body relative to the housing, wherein the cap assembly further comprises an elevation member being movable rotationally and axially relative to the cap body, wherein the elevation member comprises a proximally facing surface configured for engaging the distally facing surface, and wherein the elevation member comprises a first rotation preventing geometry configured to prevent the elevation member from rotating relative to the housing, wherein said cam interface comprises engaging cam surfaces respectively disposed on the elevation member and the cap body, the cam surfaces being configured to engage slidingly upon rotation of the cap body relative to the housing so as to cause the proximal facing surface of the elevation member to be axially forced against the distally facing surface while moving the cap body, the shield remover and the needle shield distally relative to the housing.
2. The injection device as in claim 1, wherein the injection device comprises a second rotation preventing geometry configured for engagement with the first rotation preventing geometry of the elevation member and configured to prevent the elevation member from rotating relative to the housing when the cap body is rotated relative to the housing.
3. The injection device as in claim 2, further comprising a needle shroud which is telescopically movable relative to the housing but prevented from moving rotationally relative to the housing, and wherein the needle shroud comprises said second rotation preventing geometry.
4. The injection device as in claim 2, wherein the housing, or a component fixedly attached to the housing, comprises said second rotation preventing geometry.
5. The injection device as in claim 1, wherein the first rotation preventing geometry of the elevation member comprises one or more axially extending ledges, each being rotationally locked relative to a respective axially extending ledge of the second rotation preventing geometry.
6. The injection device as in claim 1, wherein either: the second rotation preventing geometry is formed on a radially outwards facing surface cooperating with the first rotation preventing geometry arranged on a radially inwards facing surface of the elevation member, or the second rotation preventing geometry is formed on a radially inwards facing surface cooperating with the first rotation preventing geometry arranged on a radially outwards facing surface of the elevation member.
7. The injection device as in claim 1, wherein the injection device comprises a distally facing flange comprising said second rotation preventing geometry provided by at least one depression or protrusion arranged at said distally facing flange, and wherein the first rotation preventing geometry of the elevation member engages the at least one depression or protrusion at said distally facing flange to provide a rotational lock between the elevation member and housing.
8. The injection device as in claim 1, wherein the elevation member is fully comprised within the cap body.
9. The injection device as in claim 1, wherein a distal portion of the elevation member is comprised within the cap body, and wherein a proximal portion of the elevation member extends proximally from the cap body.
10. The injection device as in claim 1, wherein the cam interface comprises a pair of cooperating rotational end blockers defining an end-of-rotation blocking position between the cap body and the housing.
11. The injection device as in claim 1, wherein the cam interface includes a pair of cooperating rotational start blockers defining a start-of-rotation blocking position between the cap body and the housing.
12. The injection device as in claim 1, wherein the injection device comprises a first indicator signifying rotation of the cap body relative to the housing and a second indicator signifying axially pulling of the cap body relative to the housing, wherein the injection device is configured to reveal, in response to rotation of the cap body, said second indicator.
13. The injection device as in claim 1, wherein the cap assembly further comprises a ratchet mechanism provided between the cap body and the elevation member, and wherein the ratchet mechanism is configured to provide tactile feedback on the distal movement of the cap body relative to the elevation member during rotation of the cap body relative to the housing.
14. The injection device as in claim 1, wherein, when the proximally facing surface of the elevation member axially engages the distally facing surface, the distally facing surface prevents the elevation member from moving proximally.
15. The injection device as in claim 1, wherein the shield remover is mounted freely rotatable relative to the cap body.
Description
BRIEF DESCRIPTION OF DRAWINGS
[0038] In the following the invention will be further described with reference to the drawings, wherein
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[0055] Corresponding reference characters indicate corresponding parts throughout the several views. Although the drawings represent embodiments of the present invention, the drawings are not necessarily to scale, and certain features may be exaggerated or omitted in some of the drawings in order to better illustrate and explain the present invention.
DESCRIPTION
[0056] In the context of the present disclosure it may be convenient to define that the term “distal end” in the appended figures is meant to refer to the end of the injection device which usually carries the injection needle whereas the term “proximal end” is meant to refer to the opposite end of the injection device pointing away from the injection needle. The shown figures are schematical representations for which reason the configuration of the different structures as well as the relative dimensions are intended to serve illustrative purposes only.
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[0060] In the shown embodiment, a syringe retaining feature 11 (only showed in
[0061] In the shown embodiment, a needle shroud 6 covers the needle 4 prior to injection and after injection. In the storage state of the injection device, and after dose administration, the cap assembly 3 covers the needle 4 and the needle shroud 6. As mentioned above, in the shown embodiment, the needle 4 is covered by a protective needle shield 5, such as a Rigid Needle Shield (RNS), that fits tight around the neck portion 8 of the syringe barrel 7 of the prefilled syringe 2 to protect bacteria's to pass between the syringe barrel 7 and the protective needle shield 5 in the area were the protective needle shield and the syringe barrel 7 part of the prefilled syringe 2 are connected.
[0062] The cap assembly 3 comprises a cap body 15 shaped to be gripped by the fingers of a user and sized to fit over the needle shield 5 and the needle shroud 6. Cap assembly 3 further features a shield remover 9 gripping the protective needle shield 5 in a manner that, upon user-initiated dose administration, the protective needle shield 5 is removed from the syringe barrel 7 by removal of the cap assembly 3 from the injection device 1, thus leaving the needle 4 uncovered. To enable the cap body 15 to be rotated the shield remover 9 is mounted freely rotatable within the cap body 15 but in a manner wherein axial movement between cap body 15 and shield remover 9 is prohibited. Hence, as the shield remover is coupled to the needle shield 5 axial movement of the cap body 15 relative to housing 10 will result in axial movement of the needle shield 5 relative to the barrel 7 of syringe 2.
[0063] Although not mandatory in connection with the broadest aspect of the present invention, the shown exemplary injection device 1 includes a needle shroud 6 protecting the needle 4 in a manner to generally obscure the needle from view. The needle shroud 6 is mounted telescopically in the housing 10 so that in the initial storage state a distal portion of the needle shroud 6 extends from the housing 10. Referring to
[0064] In use, the needle shroud 6 is pushed against the body to enable, e.g. triggering, an injection. A needle shroud spring 13 enables the needle shroud 6 to be forced back to the extended position where the needle 4 again is covered once the pressure from pushing the needle shroud 6 against the body is relieved.
[0065] In addition to the cap body 15 and the shield remover 9, the cap assembly 3 comprises an elevation member 12, enabling the cap assembly 3 to be twisted off the protective needle sheath 5 to be pulled off the needle 4 when twisting off the cap body 15 relative to the housing 10. The shield remover 9 is illustrated as a separate part permanently attached to the cap body 15 in a manner enabling the shield remover 9 to remain in a stationary rotational position relative to the needle shroud 6, the syringe barrel 7 and the housing 10 once the cap body is twisted off whereas the cap body 15 is changing its rotational and axial position. The shield remover 9 remains in the same axial position as the cap body 15 once the cap body is twisted off. Thus, the shield remover 9 is a separate part of the cap assembly 3 attached to the cap body 15 to only enable a rotational movement. The purpose of a rotationally attached shield remover 9 is to enable the protective needle sheath 5 to be removed from the needle 4 and the syringe barrel neck 8 in an axial direction once the cap body 15 is twisted. In the shown embodiment, the elevation member 12 is formed as a sleeve shaped member arranged coaxially between the shield remover 9 and the cap body 15, i.e. in a manner wherein the elevation member is fully accommodated within the cap body 15. In the shown embodiment, although not identifiable in the figures, the elevation member 12 is mounted axially slideable within the cap body between axial end limits. Referring to
[0066] A cam interface 20 is arranged between the cap body 15 and elevation member 12. The cam interface in the shown embodiment is formed as elevation tracks provided as helical cam surfaces disposed on the cap body 15 and the elevation member 12, respectively. The cam interface 20 enables the cap body 15 to be elevated in the distal direction in the course of the cap body 15 being turned by the user. As the elevation member 12 is locked rotationally to the needle shroud 6 by ridges 18 on the inside of the elevation member 12 fitting into recesses 19 in the outer surface of the needle shroud 6 the helical cam surfaces are forced to slidingly engage each other as the cap body 15 is twisted relative to the housing 10 and, as a consequence, the elevation member 12 is forced proximally relative to the cap body 15. As the proximally facing surface 17 on elevation member 12 is pressed towards the distal facing rim portion of the housing 10 the cap body 15 is forced axially in the distal direction relative to housing 10 and syringe 7. As a result the shield remover 9 and the needle shield 5 is detached axially from the neck portion 8 of the barrel of the syringe 2.
[0067] The ridges 18 and the recesses 19 are formed in a manner enabling the cap assembly 3 including the elevation member 12 to be interconnected in an axial direction to the needle shroud 6 during assembly and to also being entirely removed from the rest of the injection device 1 by pulling the cap assembly 3 including the elevation member 12 in an axial direction after the cap body 15 has been rotated sufficiently, or at any time the user would like to pull off the cap assembly 3 instead of twisting off the cap assembly 3. In the shown first embodiment, a precondition for the elevation member 12 to be rotationally locked when twisting the cap body 15 relative to the housing is the fact that the needle shroud 6 is rotationally locked to the housing 10.
[0068] Reference is now made to
[0069] To provide tactile feedback for the user that the cap assembly 3 is rotated sufficiently and that it is time for the cap assembly 3 to be removed by simply pulling the cap assembly 3 away from the housing 10, the cam interface may include rotational end blockers, which in the shown embodiment are formed as cooperating axially extending ledges 21 (See
[0070] Furthermore, the cap assembly 3 and the housing 10 may show a visual indication feature to guide the user to the steps to be made to remove the cap assembly 3. A rotation arrow 23 on the front of the cap body 15, or both on the front and on the rear side of the cap body 15, tells the user how to rotate the cap assembly 3. As shown in the first embodiment, a pull arrow 24 may be arranged on a radial outer surface of housing 10. Once the cap body 15 is rotated to its end position, accompanied by axial movement of the cap body, the pull arrow 24 on the housing 10, which initially has been hidden by the cap body 15, has appeared and is aligned with the end of the longer horizontal line portion of the rotation arrow 23. This is an indication for the user that it is time to fully remove the cap assembly 3 by pulling the cap assembly 3 away from the rest of the injection device 1. To enable the elevation member 12 to always be positioned in a well-defined manner under the cap assembly 3 there are formed support ribs 25 on the inside of the cap body 15 and a corresponding elevation member upper rim 26 to hold the elevation member 12 in position. Once the cap assembly 3 is rotated the support ribs 25 give a tactile feedback to the user and function as an invisible indication that two elements are moving relative to each other as the elevation member upper rim 26 will slide over the support ribs 25 (cf.
[0071] As described above, the cap assembly 3 is provided with an elevation member 12 which is rotationally locked relative to the needle shroud 6 by means of a physical engagement between the elevation member 12 and the needle shroud 6 providing the rotational lock between the two parts but also enabling an axial disengagement of the elevation member 12 from the needle shroud 6. In the first embodiment the elevation member 12 is locked rotationally to the needle shroud 6 by ridges 18 on the radial inwards surface of the elevation member 12 fitting into recesses 19 in the radial outwards facing surface of the needle shroud 6. There are two ridges 18 and two recesses 19 as described in order to obtain sound kinematics for the construction versus e.g. one ridge 18 and one recess 19. However, the geometries may in alternative embodiments be provided, by making e.g. three or more sets of ridges 18 and recesses 19. A substitute for ridges 18 and recesses 19 could be a regular triangular-, square-, pentagon-, or hexagon shapes, or other equilateral shapes or any other variation of shapes enabling the above-mentioned rotational lock and the axial disengagement. Also, the choice of ridges 18 on the inner of the elevation member 12 fitting into recesses 19 in the outer surface of the needle shroud 6 could be made differently as ridges 18 could be disposed on the outer surface of the needle shroud 6. Instead of making a suitable geometry on the outside of the needle shroud 6, any geometry enabling the rotational lock and the axial disengagement could be situated on a radially inwards surface of the needle shroud 6.
[0072] The shield remover 9 in the drawings is illustrated as a separate part permanently attached to the cap body 15 in a manner enabling the shield remover 9 to remain in a stationary rotational position relative to the needle shroud 6, the syringe barrel 7 and the housing 10 once the cap assembly 3 is twisted off whereas the cap body 15 is changing both its rotational and axial position relative to the housing 10. The shield remover 9 remains in the same axial position as the cap body 15 once the cap assembly 3 is twisted off. Thus, the shield remover 9 is a separate part, attached to the cap body 15 in a way that enables the shield remover to rotate freely relative to the cap body 15. The purpose of a rotation function related to the shield remover 9 is to enable the protective needle sheath 5 to be removed from the needle 4 and the neck 8 of the syringe barrel 7 in an axial direction once the cap assembly 3 is twisted. This type of shield remover 9 is well known in the art. Other embodiments of the injection device 1 may be formed with a cap assembly 3 were the shield remover 9 is a non-separate part integrated in the cap body 15, formed in a way that it will hook on the protective needle sheath 5 during assembly and will pull off the protective needle sheath 5 from the neck 8 of the syringe barrel 7 and the needle 4 once the cap assembly 3 is rotated or simply pulled off. In such embodiment it is possible to rotate the cap body 15, including the integrated shield remover 9 relative to the protective needle sheath 5 during removal of the cap assembly 3 and accordingly the protective needle sheath 5 following the axial movement of the cap. Thus, also in this case, the protective needle sheath 5 will be removed in an axial direction.
[0073] Whatever the shield remover 9 is an integrated part of the cap body 15, or it is a separate part, attached to the cap body 15, the elevation member 12 can be integrated in either concept. The figures show two sets of elevation tracks 20 positioned rotationally 180 degrees from each other and the elevation tracks 20 end with end stop walls 21 parallel to the central longitudinal axis of the injection device 1. To enable the cap assembly 3 to be only twisted in one direction when starting the twisting of the cap assembly 3 the start stop walls 22 provide such rotational blocking. It can be chosen to leave out the end stop walls 21, resulting in a less preferable user feedback. It is also possible to only form either the elevation tracks 20 only in the cap body 15 or only in the elevation member 12. In that case ridges in either the cap body 15 or the elevation member 12 could follow the elevation tracks and 20 once the cap assembly 3 is rotated in order to push the cap assembly 3 off the injection device 1. Instead of two elevation tracks 20, or two sets of elevation tracks 20, it is possible to provide alternative embodiments with three elevation tracks 20, or three sets of elevation tracks 20. It is also possible to form the tracks as mirrored tracks, forming V-shapes. In that case the cap assembly 3 can be removed by rotation in either direction, clock-wise or anti-clock-wise.
[0074] Instead of linking the elevation member 12 to the needle shroud 6 for enabling the rotational lock and relative axial displacement, the elevation member 12 may be linked directly to the housing 10.
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[0076] The rotational lock is secured by a geometry ensuring rotational locking of the elevation member 12 relative to the housing 10, while enabling axial movement therebetween. In
[0077] The description above with respect to the figures has been provided to give background information on the use of an exemplary injection device applicable for use with the present invention. However, the injection device described is one of many different available injection devices that can be utilized with the principles according to the present invention. It should be stressed that the invention is not limited to the shown embodiment and the described variants but may be embodied in other ways within the subject matter defined in the following claims and within the remaining disclosure.