Medicament Delivery Device and Actuation Mechanism for a Drug Delivery Device

Abstract

Described is an actuation mechanism for a medicament delivery device having a needle with a distal tip. The actuation mechanism comprises an outer sleeve telescopically relative to the delivery device and an inner sleeve telescopically arranged relative to the outer sleeve. The outer sleeve is axially translatable relative to the delivery device, and the inner sleeve is axially translatable relative to the outer sleeve. In a first state, the inner sleeve protrudes distally from the outer sleeve and the outer sleeve protrudes distally from the delivery device. In a second state, the inner sleeve is contained within the outer sleeve. Movement of the outer sleeve proximally relative to the delivery device in the second state initiates delivery of a medicament in the delivery device.

Claims

1-12. (canceled)

13. A medicament delivery device comprising: a housing; an outer sleeve positioned at least partially within the housing and configured to telescopically and distally extend from the housing; and an inner sleeve positioned at least partially within the outer sleeve and configured to telescopically and distally extend from the outer sleeve, wherein, in a pre-injection state of the medicament delivery device, the inner sleeve is movable proximally further into the outer sleeve to place the medicament delivery device in an injection state in which the inner sleeve and the outer sleeve extends distally from the housing and a needle extends distally from the inner sleeve and the outer sleeve.

14. The medicament delivery device of claim 13, wherein the inner sleeve is movable proximally relative to the outer sleeve to initiate delivery of a medicament from the medicament delivery device.

15. The medicament delivery device of claim 13, wherein, in the pre-injection state, the inner sleeve covers a distal tip of the needle.

16. The medicament delivery device of claim 13, wherein the inner sleeve is configured to be repeatedly retracted into the outer sleeve without placing the medicament delivery device in the injection state.

17. The medicament delivery device of claim 13, wherein the inner sleeve is movable between a proximal position in which the medicament delivery device is in the pre-injection state and a distal position in which the medicament delivery device is in the injection state, wherein the medicament delivery device comprises a spring configured to bias the inner sleeve toward the proximal position.

18. The medicament delivery device of claim 13, wherein the outer sleeve is movable proximally further into the housing.

19. The medicament delivery device of claim 13, wherein, in the pre-injection state, the outer sleeve is locked relative to the housing.

20. The medicament delivery device of claim 13, wherein, in the injection state of the medicament delivery device, the inner sleeve and the outer sleeve are configured to be pressed against skin of a patient.

21. The medicament delivery device of claim 13, wherein the inner sleeve is movable to a position in which the inner sleeve is fully contained within the outer sleeve.

22. The medicament delivery device of claim 13, wherein, in the injection state of the medicament delivery device, a distal end of the inner sleeve is co-planar with a distal end of the outer sleeve.

23. The medicament delivery device of claim 13, further comprising a cartridge comprising the needle, wherein the cartridge contains a medicament.

24. The medicament delivery device of claim 23, wherein the medicament comprises an antibody or fragment thereof.

25. The medicament delivery device of claim 13, wherein the medicament delivery device is an autoinjector configured to automatically deliver a dose of medicament upon being placed in the injection state.

26. The medicament delivery device of claim 13, wherein, in the injection state of the medicament delivery device, the inner sleeve is movable distally relative to the outer sleeve to place the medicament delivery device in a post-injection state, wherein, in the post-injection state of the medicament delivery device, the inner sleeve covers the needle.

27. An actuation mechanism for a medicament delivery device, the actuation mechanism comprising: an outer sleeve configured to telescopically and distally extend from a housing of a medicament delivery device; and an inner sleeve configured to telescopically and distally extend from an outer sleeve, wherein, in a pre-injection state of the actuation mechanism, the inner sleeve is movable proximally further into the outer sleeve to place the actuation mechanism in an injection state, wherein, in the injection state of the actuation mechanism, the inner sleeve and the outer sleeve extends distally from the housing and a needle extends distally from the inner sleeve and the outer sleeve, and the inner sleeve is movable distally relative to the outer sleeve to place the actuation mechanism in a post-injection state, and wherein, in the post-injection state of the actuation mechanism, the inner sleeve covers the needle.

28. The actuation mechanism of claim 27, wherein the inner sleeve is movable proximally relative to the outer sleeve to initiate delivery of a medicament from the medicament delivery device.

29. The actuation mechanism of claim 27, wherein, in the pre-injection state of the actuation mechanism, the inner sleeve covers a distal tip of the needle.

30. The actuation mechanism of claim 27, wherein the inner sleeve is configured to be repeatedly retracted into the outer sleeve without placing the actuation mechanism in the injection state.

31. The actuation mechanism of claim 27, wherein the inner sleeve is movable between a proximal position in which the actuation mechanism is in the pre-injection state and a distal position in which the actuation mechanism is in the injection state, wherein the actuation mechanism comprises a spring configured to bias the inner sleeve toward the proximal position.

32. The actuation mechanism of claim 27, wherein the outer sleeve is movable proximally further into the housing.

33. The actuation mechanism of claim 27, wherein, in the pre-injection state of the actuation mechanism, the outer sleeve is locked relative to the housing of the medicament delivery device.

34. The actuation mechanism of claim 27, wherein, in the injection state of the actuation mechanism, the inner sleeve and the outer sleeve are configured to be pressed against skin of a patient.

35. The actuation mechanism of claim 27, wherein the inner sleeve is movable to a position in which the inner sleeve is fully contained within the outer sleeve.

36. The actuation mechanism of claim 27, wherein, in the injection state of the actuation mechanism, a distal end of the inner sleeve is co-planar with a distal end of the outer sleeve.

37. The actuation mechanism of claim 27, wherein, in the injection state of the actuation mechanism, the inner sleeve is movable distally relative to the outer sleeve to place the actuation mechanism in a post-injection state, wherein, in the post-injection state of the actuation mechanism, the inner sleeve covers the needle.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0085] The present invention will become more fully understood from the detailed description given hereinbelow and the accompanying drawings, which are given by way of illustration only, and thus, are not limitive of the present invention, and wherein:

[0086] FIG. 1 shows an exemplary embodiment of a medicament delivery device before use, and

[0087] FIG. 2 shows an exemplary embodiment of a medicament delivery device during use.

[0088] Corresponding parts are marked with the same reference symbols in all figures.

DETAILED DESCRIPTION

[0089] FIGS. 1 and 2 show an exemplary embodiment of a medicament delivery device 1 before and during administration of a medicament to a patient, respectively. Those of skill in the art will understand that the patient may be a human or animal. In the exemplary embodiment, the delivery device 1 is an autoinjector designed to automatically deliver a dose of a medicament by means of a needle 2 upon sleeve-driven actuation. Those of skill in the art will understand that the delivery device 1 may be a pen injector, a syringe, an infusion device, etc.

[0090] An exemplary embodiment of a sleeve-driven actuation mechanism comprises a housing 5, an inner sleeve 3 and an outer sleeve 4 telescopically arranged on the inner sleeve 3. The inner sleeve 3 and the outer sleeve 4 are axially translatable relative to each other and relative to the housing 5. The inner sleeve 3 covers the needle 2 before and after use of the delivery device 1 to prevent accidental needlestick injuries. The outer sleeve 4 serves to actuate a delivery mechanism in the delivery device 1. The sleeves 3, 4 may be arranged telescopically and substantially shaped as hollow cylinders with open proximal ends. The outer sleeve 4 has an open distal end 4.1 for accommodating the inner sleeve 3. A distal end 3.1 of the inner sleeve 3 may be opened or have a cover face with a central aperture for accommodating projection of the needle 2. In an exemplary embodiment, the distal end 3.1 of the inner sleeve 3 may be planar or curved.

[0091] FIG. 1 shows an exemplary embodiment of the delivery device 1 in a first state, e.g., prior to use on an injection site 7. In the first state, the outer sleeve 4 projects distally out of the housing 5, and the inner sleeve 3 projects distally out of the outer sleeve 4. In the first state, the sleeves 3, 4 cover a distal needle tip 2.1 of the needle 2 and thus prevent accidental needlestick injuries. For example, in the first state, the distal needle tip 2.1 of the needle 2 may be proximal of the distal end 4.1 of the outer sleeve 4.

[0092] In an exemplary embodiment, in the first state, the inner sleeve 3 may be axially translatable relative to the outer sleeve 4, but the outer sleeve 4 may be locked relative to the housing 5. Thus, the inner sleeve 3 may be repeatedly retracted into the outer sleeve 4 a predetermined distance without triggering delivery of the medicament. This may prevent inadvertent triggering of the delivery device 1, allowing for realignment of the delivery device 1 on a different injection site.

[0093] In an exemplary embodiment, the inner sleeve 3 may be biased in the first state by a first spring element, and the outer sleeve 4 may be biased in the first state by a second spring element.

[0094] FIG. 2 shows an exemplary embodiment of the delivery device 1 in a second state, e.g., during use. When the delivery device 1 is pressed against an injection site, the inner sleeve 3 may be pushed into an intermediate position in which it is fully contained inside the outer sleeve 4, and the distal end 4.1 of the outer sleeve 4 touches the injection site 7. When the distal end 3.1 of the inner sleeve 3 is in a same plane as the distal end 4.1 of the outer sleeve 4, the inner sleeve 3 and the outer sleeve 4 may be coupled together so that further pressing of the delivery device 1 against the injection site 7 causes the sleeves 3, 4 to move together proximally relative to the housing 5. For example, the inner sleeve 3 may engage the outer sleeve 4 when the inner sleeve 3 has attained a predetermined axial position relative to the outer sleeve 4.

[0095] In an exemplary embodiment, when the inner sleeve 3 engages the outer sleeve 4, the needle 2 may be inserted into the injection site 7 and the medicament may be delivered. In another exemplary embodiment, when the outer sleeve 4 is pressed against the injection site 7, the needle 2 may be inserted into the injection site 7 and the medicament may be delivered.

[0096] A tactile feedback may be provided in the form of resistance. For example, the first spring element associated with the inner sleeve 3 may require less force to compress than the second spring element associated with the outer sleeve 4. Thus, an increased force may be necessary to cause the outer sleeve 4 to move proximally, axially relative to the housing 5. This has the advantage that the patient can clearly distinguish the two steps of the process and thus removes a potential patient's feeling of insecurity concerning the injection process. A further advantage of the actuation mechanism according to the invention is that the different pressures for the two steps of the process can be realized more easily because they are induced automatically by coupling the sleeves to different compression springs. Of course, in alternative embodiments, the compression springs may be replaced by other tensioning members.

[0097] In an exemplary embodiment, the sleeves 3, 4 have different colors or indicia. For example, different colors emphasize the different functions of the sleeves 3, 4 and thus distinguish the two steps of the injection process even more clearly.

[0098] After the injection process, the delivery device 1 is withdrawn from the injection site 7. When force is removed from the sleeves 3,4, the compression springs relax and shift the sleeves 3, 4 distally toward the first state so that they again cover the needle 2. Thus, advantageously accidental needlestick injuries are prevented after use of the delivery device 1.

[0099] In a preferred extension of the invention, the delivery device 1 additionally comprises additionally a locking mechanism, which locks the position of the inner sleeve 3 and/or the position of the outer sleeve 4 relative to each other and/or the housing 5. The locking mechanism may ensure that the inner sleeve 3 and/or outer sleeve 4 cover the distal needle tip 2.1. This advantageously further reduces the risk of accidental needlestick injuries after using the delivery device 1.

[0100] For instance, the locking mechanism may comprise at least one latch member of the inner sleeve 3 or the outer sleeve 4 and a corresponding groove located in the housing 5 of the drug delivery device 1, the groove being adapted to receive the latch member. Alternatively, the latch member may be part of the housing 5 and the groove may be located in a sleeve 3, 4.

[0101] Those of skill in the art will understand that modifications (additions and/or removals) of various components of the apparatuses, methods and/or systems and embodiments described herein may be made without departing from the full scope and spirit of the present invention, which encompass such modifications and any and all equivalents thereof.