AUTO-INJECTION DEVICE

Abstract

The present disclosure relates to an autoinjector device for use in combination with a syringe, said syringe comprising a movable plunger; a needle; and a tubular needle shield. The claimed autoinjector device comprises: an elongated housing having a proximal and a distal end; a drive mechanism; a syringe holder in order to support the fragile syringe and to prevent damage to the syringe. The invention furthermore relates to a method for assembly of the autoinjector device according to the invention.

Claims

1-10. (canceled)

11. A subassembly for use in fabricating a medical delivery device, wherein the subassembly comprises: a first axial configuration and a second axial configuration; a housing having a longitudinal axis and a support surface located on an inside surface of the housing; a syringe holder partially inserted into a distal end of the housing when the subassembly is in the first axial configuration; and a syringe having a needle shield affixed to the proximal end of the syringe adjacent to a neck portion of the syringe, where the needle shield has an outer diameter; wherein the syringe holder further comprises an open proximal end having radially inward directed shoulders arranged around an inner periphery of the open proximal end, wherein the radially inward directed shoulders define a first diameter and a second diameter, where the first diameter is less than the second diameter, wherein the first diameter temporarily changes to the second diameter when subassembly is in the first axial configuration and the syringe is longitudinally inserted into the syringe holder so that the needle shield is pushed through the open proximal end until the neck of the syringe is supported by the radially inward directed shoulders causing the second diameter to change back to the first diameter, wherein the syringe holder is movably arranged in the housing such that when the subassembly is in the second axial configuration an outer surface of the syringe holder will abut the support surface to prevent the radially inward directed shoulders from flexing radially outward.

12. The subassembly of claim 11, wherein the support surface is not abutting or in contact with the outer surface of the syringe holder when the subassembly is in the first axial configuration.

13. The subassembly of claim 11, wherein the support surface comprises a plurality of surfaces that surround the outer surface of the syringe holder when the subassembly is in the second axial configuration.

14. The subassembly of claim 13, wherein each of the surfaces has a cross-sectional shape that corresponds to the outer surface of the syringe holder

15. The subassembly of claim 11, wherein the syringe holder has a distal supporting collar arranged around and in contact with the outer surface of the syringe holder.

16. The subassembly of claim 15, wherein the distal supporting collar comprises a surface that is perpendicular to the longitudinal axis and configured to abut a proximal side of a radially extending flange of the syringe when the subassembly is in the first axial configuration and in the second axial configuration.

17. The subassembly of claim 11 further comprising a protrusion for controlling movement of the syringe holder within the housing when the subassembly transitions from the first axial configuration to the second axial configuration.

18. The subassembly of claim 17, wherein the protrusion comprises a plurality of protrusions along the outer surface of the syringe holder wall and the housing further comprises a plurality of corresponding grooves along an inner periphery of the housing.

19. The subassembly of claim 11 further comprising a fastener for securing the syringe holder in relation to the housing when the subassembly is in the second axial configuration.

20. The subassembly of claim 11, wherein the outer diameter of needle shield is larger than the first diameter.

21. A method of assembling a subassembly of a medical delivery device, the method comprising the steps of: providing a housing having a longitudinal axis and a support surface located on an inside surface of the housing; partially inserting a syringe holder into the distal end of the housing, where the syringe holder has an open distal end and an open proximal end having radially inward directed shoulders arranged around an inner periphery of the open proximal end; providing a syringe having a needle shield affixed to the proximal end of the syringe adjacent to a neck portion of the syringe, where the needle shield has an outer diameter; forming a first axial configuration of the subassembly by inserting the proximal end of a syringe into the distal end of the syringe holder and moving the syringe axially relative to the syringe holder so that the needle shield is pushed through the open proximal end until the neck of the syringe is supported by the radially inward directed shoulders; forming a second axial configuration of the subassembly axially moving the syringe holder and the syringe proximally relative to the housing until the support surface abuts an outside surface of syringe holder so as to prevent the radially inward directed shoulders from flexing radially outward.

22. The method of claim 21 further comprising contacting a flange of the syringe with a distal supporting collar of the syringe holder.

23. The method of claim 21 further comprising moving both the syringe holder and the syringe simultaneously to form the second configuration of the subassembly.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0029] One embodiment of the present invention is illustrated in the appended figures, said figures disclosing:

[0030] FIG. 1 illustrates a perspective view of a syringe assembled in a syringe holder.

[0031] FIG. 2 illustrates a perspective view of a syringe holder.

[0032] FIGS. 3a, 3b and 3c illustrate exploded views of the autoinjector device at different steps during the assembly of the autoinjector device.

DETAILED DESCRIPTION

[0033] In FIGS. 3a to 3c, selected components of an autinjector device 10 according to the invention are illustrated. The autoinjector device 10, elongated along a longitudinal axis A, is intended for self-administration of drugs and has a proximal end 11 and an opposing distal end 12.

[0034] The autoinjector device comprises an autoinjector housing divided into a proximal housing section 13 and distal housing section 14 in order to make the space defined inside the housing accessible for assembly of the different components of the autoinjector.

[0035] The autoinjector housing has the shape of a tube. The autoinjector housing is intended to house a pre-filled syringe 30 within a syringe holder 40. A drive mechanism (not shown) is also arranged within the housing. The drive mechanism is arranged to apply a proximally directed drive force to a movable plunger in the syringe in order to expel the drug through a needle(not shown).

[0036] The drive mechanism is not illustrated in detail in the drawings but different types of drive mechanisms are available. The drive mechanism may comprise a pre-tensioned spring which upon activation applies a pre-determined pressure via plunger rod (not shown) to the movable plunger arranged in a distal end of the syringe.

[0037] The autoinjector is intended for use in combination with a standard pre-filled syringe 30. The syringe 30, assembled in the syringe holder 40 illustrated in perspective in FIG. 2, has a substantially circular cross section having an outer diameter. The syringe is normally made of glass in order to ensure a reliable and hygenic storing of the drug in the syringe 30. At a proximal end of the syringe 30, the outer diameter is reduced and shaped like a neck 32 at which a needle (not shown) and needle shield 34 are attached before delivery of the syringe. In order to ensure that the needle remains sterilized before use, the needle is protected by the needle shield 34 having a substantially circular cross section and having an outer diameter which is larger than the outer diameter of the elongated syringe. The tubular needle shield 34 may be a so-called Rigid Needle Shield (RNS). Further, the tubular needle shield 34 encloses the needle and is removably fastened to the syringe 30 at the neck 32. The distal end of the tube-shaped syringe 30 is arranged with a radially extending flange 35. The syringe 30 furthermore comprises a movable plunger arranged in the distal end of the syringe 30 to seal the syringe 30 and ensure that the pre-filled drug of the syringe remains in the syringe 30. The movable plunger is preferably made of a rubber material in order to achieve a seal between the inner periphery of the syringe 30 and the plunger.

[0038] The syringe 30 is secured in the autoinjector housing by a syringe holder 40 that is described in more detail below. The syringe holder 40 is arranged in the proximal housing section in order to support and maintain the syringe 30 in a pre-determined position in relation to the syringe holder and the autoinjector housing. During assembly of the autoinjector, the syringe 30 is first inserted in the syringe holder 40, which is then moved in the proximal direction of the autoinjector device 10 to a forward position where the syringe holder 40 is secured in the proximal housing section. The movement of the syringe holder in the proximal housing section is facilitated by guiding means 41 consisting of corresponding longitudinal protrusions 42 along the outer periphery of the syringe holder 40 and longitudinal recesses along the inner periphery of the proximal housing section. Furthermore corresponding snap-fitting fastening means 43 are arranged on the syringe holder 40 and the proximal housing section in order to permanently secure the syringe holder in the desired proximal position within the proximal housing section.

[0039] The syringe holder 40 provides a reliable and effective support for the fragile syringe 30 and reduces the risk of damage to the syringe 30. One embodiment of the syringe holder 40 is illustrated in FIG. 2 in a perspective view, where it is separated from the other components of the autoinjector device. The syringe holder 40 has a tubularly shaped holder wall 44 with a proximal end 45 and a distal end 46. The proximal end 45 of the syringe holder is open but provided with a proximal supporting collar 47 arranged around the inner periphery of said syringe holder wall in order to support said syringe neck 32 in the proximal longitudinal direction. Further, the proximal supporting collar 47 has a inner diameter which is lesser than the outer diameter of the elongated syringe and thus also lesser than the outer diameter of the tubular needle shield. A slot 48 extends from said open proximal end in the distal direction resulting in a C-shaped cross sectional shape of the syringe holder wall in the proximal end. The C-shaped holder wall in the proximal end 45 is able to flex radially outward which is essential in order to fit the syringe 30 in the syringe holder 40 since the tubular needle shield 34 has an outer diameter exceeding the inner diameter of the opening in the proximal supporting collar 47. This means that the syringe 30 may be fitted in the syringe holder 40 from the distal end 46 of the syringe holder. The syringe 30 is then moved in the proximal direction within the syringe holder 40. When the tubular needle covering shield 34 reaches the proximal supporting collar 47, the C-shaped holder wall will flex radially outward and thereby make it possible to move the syringe 30 further until the neck 32 of the syringe 30 is in contact with the collar 47, i.e the desired position of the syringe 30 within the syringe holder 40. In this position the needle shield 34 has completely passed the supporting collar 47, allowing the C-shaped holder wall to flex back, radially inward, behind the needle shield, such that the collar supports the syringe at the neck 32.

[0040] The syringe holder 40 furthermore comprises a distal supporting collar 49 arranged around the outer periphery of said syringe holder wall 44 and has a longitudinal length between the proximal supporting collar 47 and a distal supporting collar 49 that corresponds to the length of the syringe 30 so that the distal supporting collar 49 of said syringe holder wall, when the syringe 30 is fitted in the desired position within the syringe holder 40, is in contact with the proximal side of the radially extending flange 35 of the syringe 30 and provides further support for the fragile syringe 30 within the syringe holder 40 at the same time as the proximal supporting collar 47 supports the neck 32 of said syringe 30. Thereby the risk of damage to the syringe 30 is reduced significantly. The syringe holder 40 furthermore comprises guiding means that facilitates its movement in the longitudinal direction of the autoinjector device and locking means for securing the syringe holder in the proximal housing section before assembly of the syringe in the syringe holder 40.

[0041] The proximal housing section is furthermore provided with a window 15, or opening, corresponding to the slot 48 in the syringe holder 40 when the syringe holder 40 is fitted in the intended position in the proximal housing section in order to make the syringe 30, and the drug in the syringe, visible from the outside of the autoinjector housing and possible for the patient to verify that the autoinjector device is correctly assembled and ready for use.

[0042] Three different assembly steps of the autoinjector device are schematically illustrated in FIGS. 3a-3c. In FIG. 3a, the proximal housing section and the syringe holder 40 are illustrated without the syringe 30 fitted in the syringe holder 40. The syringe holder 40 is movably arranged in the proximal housing section between a distal position and a proximal position. Prior to fitting the syringe in the syringe holder the syringe holder is arranged in the distal position ready for assembly.

[0043] The assembly of the autoinjector device 10 is initiated by fitting the syringe 30 in the syringe holder 40 by inserting the proximal end of the syringe in the distal end of the syringe holder 40 and pushing the syringe in the proximal direction until the neck 32 of the syringe 30 is in contact with the collar 47 in the proximal end of the syringe holder40, where the collar has a plurality of radially inward directed shoulders 47a, illustrated in FIG. 3b. The syringe 30 and the syringe holder 40 are then moved simultaneously in the proximal direction to the proximal position in the proximal housing section. In the proximal position, the outer periphery of the proximal end of the syringe holder 40 will be surrounded by support surfaces 16 on the inside surface of the proximal housing section. The cross sectional shape of the support surfaces correspond to the outer periphery of the syringe holder in order to provided a rigid support and prevent the C-shaped wall of the proximal end from flexing radially outwards in order to secure the syringe 30 in the syringe holder 40 and the autoinjector device 10, illustrated in FIG. 3c. Finally, the autoinjector housing is closed around the syringe 30 by fitting the distal housing section to the proximal housing section.

[0044] The assembly method of the present invention accordingly comprises the steps: [0045] a). Inserting the proximal end of the syringe 30 in the distal end of the syringe holder 40; [0046] b). Moving the syringe 30 towards the proximal end of the syringe holder until the neck 32 of the syringe 30 is in contact with the proximal supporting collar 47 and the radially extending flange 35 of the syringe 30 in contact with the distal supporting collar 49 of the syringe holder 40; [0047] c). Moving the syringe holder 40 and the syringe 30 simultaneously towards the proximal end of the autoinjector device 10.

[0048] The different embodiments described above could be combined in different ways and modified further without departing from the scope of the invention that is defined by the claims.