JP2024540018A - Auto-injector - Google Patents

Abstract

The present invention relates to an automatic injector (10) comprising a housing (12) and a needle guard (18) axially movably mounted within the housing for movement between a retraction phase, an administration phase and a lockout phase, the needle guard having different axial positions relative to the housing during the retraction phase, the administration phase and the lockout phase, the needle guard being configured to move axially in a proximal direction between the administration phase and the lockout phase.
[Selected figure] Figure 10

Description

The present invention relates to an automatic injector comprising a housing and a needle guard axially movably mounted within the housing for movement between a retraction phase, an administration phase and a lockout phase, the needle guard being configured to assume different axial positions relative to the housing during the retraction phase, the administration phase and the lockout phase, and the needle guard being configured to move axially in a proximal direction between the administration phase and the lockout phase.

Auto-injectors are generally disposable devices configured to administer medication from a pre-filled syringe. Such devices are intended for single use and are intended for administration by the patient (i.e., self-administration) or by a caregiver. At the time of use, the user removes a protective cap from the proximal end of the auto-injector, positions the auto-injector at an injection site (typically the skin of the thigh or abdomen), and pushes the auto-injector axially proximally to achieve needle insertion of the pre-filled syringe needle into the skin and initiate administration.

One objective of the present invention is to make available an auto-injector that is made in a very simple process from a very small number of low-cost components compared to the state of the art. A further objective of the present invention is to make available a design that is as compact as possible.

This object is met by an automatic injector comprising the subject matter of claim 1.

Such an automatic injector includes a housing, a prefilled syringe mounted within the housing and fixed relative to the housing, a needle guard axially movably mounted within the housing for movement between a storage phase, an administration phase, and a lockout phase, the needle guard having one or more clip arms configured to engage corresponding notches in the housing of the automatic injector during the storage phase, and a drive chassis biased relative to the housing and further fixed relative to the housing and adapted to move the prefilled syringe between a storage phase, an administration phase, and a lockout phase. and a drive chassis configured to move relative to the housing during a retraction phase of the injector and to axially move and act on the prefilled syringe during administration, the drive chassis including one or more trigger arms, the needle guard configured to move axially distally between the retraction phase and the administration phase, and the needle guard configured to move axially proximally between the administration phase and the lockout phase, and each one of the one or more trigger arms configured to engage each one of the one or more clip arms of the needle guard when the needle guard is moved proximally between the administration phase and the lockout phase.

The trigger arm may be configured to bias the clip arm toward the housing, thereby ensuring that the clip arm engages the notch at the end of administration to secure the needle guard to the housing after administration of the medication has been administered.

In this manner, the drive chassis is configured to prevent one or more clip arms from engaging the housing during release of the needle guard when the auto-injector transitions from the administration phase to the lockout phase.

In this regard, it should be noted that the needle guard may protrude further from the housing when in the lockout phase than when in the retracted phase. In this way, after use of the auto-injector, the needle of the pre-filled syringe can be completely surrounded by the needle guard, leading to better protection against accidental needle sticks.

Because of the disposable nature of single-use auto-injectors, it is deemed advantageous to thus minimize the auto-injector's complexity, material usage, package size, and assembly complexity (all of which tend to reduce cost and environmental impact), and this is achieved by the auto-injector presented herein, specifically by providing the needle guard with a mechanism that can engage and disengage from the housing at various stages of use.

Such an arrangement also leads to a reduction in the size of the device since the needle guard has several functions associated with the device, thereby leading to a reduction in the number of parts required and therefore a reduction in the amount of raw materials used.

In addition, fewer parts are used, reducing the cost of manufacturing the device and simplifying the assembly process.

Smaller devices also reduce the volume required for transportation and storage, which can be especially expensive if low temperatures are required. This also reduces the carbon footprint associated with such auto-injectors.

In this connection, it should be noted that the drive chassis is a component that may be configured to move in a linear manner within the housing in order to expel the medicament stored in the prefilled syringe from the prefilled syringe disposed in the housing when the auto-injector is actuated by pulling the plunger of the prefilled syringe in a manner known per se.

Providing a plunger arm on the needle guard that activates the release mechanism of the auto-injector allows for a more compact design of the auto-injector. Furthermore, such a plunger arm can reliably assist in triggering the auto-injector in as simple a manner as possible.

In addition, locating the release mechanism between the auto-injector housing and the drive chassis ensures that an even more compact design of the auto-injector can be achieved.

In this regard, it should further be noted that the axial positions of the needle guard during the retraction and lockout phases can be the same axial position or can be different axial positions.

The auto-injector may further include a lockout spring disposed between the needle guard and the housing. Such a lockout spring assists in moving the needle guard relative to the housing during various stages of use.

The needle guard may be configured to compress the lockout spring when moving between the retraction stage and the administration stage, and the needle guard may be configured to move between the administration stage and the lockout stage by relaxing the lockout spring.

For example, two or more clip arms may be provided, one on each side of the needle guard, with a lockout spring disposed between the two or more clip arms. In this way, the most compact assembly possible can be formed.

The needle guard may include a protrusion that protrudes toward the housing, with the lockout spring disposed on the protrusion. Such a protrusion may be used to assist in guiding the lockout spring. The protrusion may cooperate with an aperture in the housing such that the range of travel of the lockout spring is predefined within the auto-injector. Such a protrusion cooperates with the aperture to also prevent radial and/or transverse displacement of the lockout spring, i.e., preventing buckling, leading to a more reliable auto-injector.

The needle guard may move axially toward the drive chassis to release the drive chassis from the housing when the auto-injector is actuated. The plunger arm may be reliably used as a trigger for the auto-injector.

The release mechanism may include one or more trigger arms disposed on the drive chassis, the one or more trigger arms cooperating with respective stop mechanisms disposed on the housing, and the plunger arm configured to deflect the one or more trigger arms upon axial movement of the needle guard in the distal direction. Such a release mechanism is simple to use and allows for a compact design of the auto-injector.

The needle guard may be configured to cooperate with the cap via one or more snap-fit connections, optionally each snap-fit connection comprising a protruding edge cooperating with a corresponding snap-fit area, and an inner surface of the housing comprising one or more grooves, one or more of said protruding edges being capable of moving axially relative to the housing within the one or more grooves as the needle guard moves axially. Such a cap protects the auto-injector against accidental actuation during the retraction phase and prevents the user from accidentally touching its needle.

The one or more clip arms may each have a block at an end, the block being configured to engage a lockout surface of a notch in the housing of the auto-injector during the lockout phase. Each such block may be a protrusion on a protrusion or the like, allowing the clip arm to engage a part of the housing to clip the needle guard, i.e., to hold the needle guard in place after the medication has been administered.

The notches may each be at least approximately L-shaped, with the lockout surface being located on a short rim of the L-shaped notch. In this manner, an engagement region for the clip arm may be formed that is easy to manufacture.

The lockout surface may be disposed at an angle to the long rim of the L-shaped notch. In this way, a surface of the notch can be provided that only interacts with the clip arm in the lockout stage.

The short and long limbs of the L-shaped notch may be arranged at an angle to each other, the angle being selected in the range of 10 to 120°, in particular 20 to 80°. In this way, it can be ensured that the clip arm cannot easily be dislodged from the lockout stage.

One or more clip arms may extend proximally from the needle guard. This helps to create as compact an auto-injector as possible.

The clip arm or arms may extend proximally from the plunger arm of the needle guard. This ensures an even more compact design of the needle guard, and therefore of the auto-injector.

The needle guard may include a plunger arm that activates a release mechanism of the auto-injector, and the release mechanism may be disposed between the housing of the auto-injector and the drive chassis.

The needle guard may include a sleeve at its proximal end. Such a sleeve may be configured to cover the needle of the auto-injector during the retraction and lockout stages to protect the user from unwanted needle sticks.

The needle guards may each be T-shaped or at least approximately T-shaped in design so that the plunger arms are arranged parallel to the axis of the auto-injector from the proximal end to the distal end of the sleeve. Such a design allows for a more compact assembly of the auto-injector.

The sleeve may include one or more elongated slots extending parallel to the axis of the auto-injector from the proximal end to the distal end of said sleeve. Such slots can be advantageously used to guide the needle guard between different stages to ensure smooth operation of the auto-injector.

The housing may comprise an inner body and an outer body, with the notch located in the inner body. Such a two-part housing is easier to manufacture, thus reducing the manufacturing costs of such an auto-injector.

The invention will now be described with reference to the drawings and the accompanying drawings, which are given by way of example only.

FIG. 1b shows a) a side view of the auto-injector in the retracted phase and b) a further side view of the auto-injector of FIG. 1a in the retracted phase. FIG. 1b shows a) a side view of the auto-injector of FIG. 1a in the administration phase, and b) a further side view of the auto-injector of FIG. 1a in the administration phase. FIG. 1 is a side view of a drive chassis for an auto-injector. FIG. 1b shows the auto-injector of FIG. 1a in the retracted stage. FIG. 1b shows the auto-injector of FIG. 1a in a stage of actuation immediately preceding the administration stage. FIG. 1b shows the auto-injector of FIG. 1a in the lockout stage. FIG. 2 shows a cap of an auto-injector. 5b is a cross-sectional view of the auto-injector in the area where the cap of FIG. 5a is placed at the needle guard end of the auto-injector. FIG. FIG. 1 is a partial cross-sectional view of the auto-injector showing a cap installed on the needle guard end of the auto-injector. FIG. 2 is a partial cross-sectional view of the auto-injector with a portion of the housing removed to reveal components of the auto-injector's release mechanism when the auto-injector is actuated. FIG. 8 is a detailed view showing the release mechanism of the automatic injector of FIG. 7. 9A and 9B are front, side and top views, respectively, of the release mechanism of FIG. 8 . FIG. 1 shows a) the position of the needle guard of the auto-injector relative to the housing in the retraction phase, and b) the position of the needle guard of the auto-injector relative to the housing in the lockout phase. FIG. 2 shows a) a partial cross-sectional view of the audible feedback member of the automatic injector in the administration stage at the end of a dose; FIG. 2 shows b) an enlarged view of the audible feedback member of the automatic injector in the administration stage at the end of a dose. 1A-1D are various views of an example of a cap for an automatic injector. 1A-1D are various views of an example of an outer body of an auto-injector. 1A-1D show various views of an example inner body of an auto-injector. 1A-1D are various views illustrating an example of a needle guard for an auto-injector. 1A-1D are various views illustrating an example of a needle shield of an auto-injector. 1A-1D are various views of an example drive chassis of an auto-injector; 11A-11D show various views of further examples of needle guards and outer bodies at different stages of use. 11A-11D show various views of further examples of needle guards and outer bodies at different stages of use. Graph where the area under the curve represents the energy absorbed (both areas and therefore the energy absorption are the same, but the peak forces are very different). 19A-19C show various views of the inner body of FIG. 18. 19A-19C are various views of the needle guard of FIG. 18. 1 is an exploded view showing components of a further type of auto-injector. FIG. 22 is a perspective view of the needle guard of the auto-injector of FIG. 21 . FIG. 22 is a perspective view of the drive chassis of the auto-injector of FIG. 21 . FIG. 22 is a perspective view of the inner body of the auto-injector of FIG. 21. FIG. 22 shows the outer body of the auto-injector of FIG. 21. FIG. 22 is a perspective view of the cap of the automatic injector of FIG. 21 . 11A-11C show various views of further types of caps. 22A-22D show various views of the auto-injector of FIG. 21 in the retracted stage. FIG. 22 shows the auto-injector of FIG. 21 during actuation of the auto-injector. FIG. 22 shows the auto-injector of FIG. 21 during the administration phase after actuation of the auto-injector. FIG. 22 shows the auto-injector of FIG. 21 in the lockout stage.

The following directional references are made with reference to the drawings and may of course vary from one viewing position to another. Furthermore, similar parts, or parts having similar functions, are referred to below using the same appearance and/or reference numerals.

Figures 1a and 1b show a side view of an auto-injector 10. The auto-injector 10 is a medical device that serves the purpose of administering a single dose of a medication M. The auto-injector 10 can be used by medical staff as well as by the patient himself to administer the medication M.

The auto-injector 10 has a housing 12 in which a syringe window 14 (see FIG. 1a) is present. A pre-filled syringe 16 is disposed within the housing 12 and is visible through the syringe window 14. The pre-filled syringe 16 is filled with a medication M.

A needle guard 18 (see, e.g., FIG. 2a) is disposed at the proximal end 28 of the auto-injector 10. The needle guard 18 serves to protect the patient from the needle 34 (see, e.g., FIG. 3b) before and after use of the auto-injector, i.e., during the retraction and lockout phases of the auto-injector 10.

In this regard, it should be noted that the terms proximal and distal refer to the location of the needle 34 relative to the patient, with proximal meaning closest to the main mass of the patient's body and distal meaning farther from the main mass of the patient's body.

FIG. 1b shows the status indicator window 20 through which the first portion outer surface 50 of the drive chassis 24 of the auto-injector 10 is visible.

The cap 70 is disposed at the proximal end 28 of the auto-injector 10, opposite the distal end 30 of the auto-injector 10. The cap 70 covers both the needle 34 and the needle guard 18 during the retraction phase of the auto-injector 10.

2a and 2b show the auto-injector 10 of FIG. 1 with the cap 70 removed and the needle guard 18 moved distally, i.e., away from the proximal end 28, into the auto-injector 10. The distal movement of the needle guard 18 into the auto-injector also engages the release mechanism 40 (see, e.g., FIG. 4).

Upon engaging the release mechanism 40, the drive chassis 24 (see also FIG. 3) moves proximally and its dispensing rim 22 moves the plunger 26 through the prefilled syringe 16 to dispense the medication M via the needle 34.

In this regard, it should be noted that the plunger 26 may be a separate part from the dosing rim 22 and may be pre-positioned within the pre-filled syringe and configured to be engaged by the dosing rim 22.

In other designs of the auto-injector 10, the plunger 26 may be part of the dosing rim 22.

Figure 2a shows that after the drive chassis 24 has been moved proximally, i.e., at the end of the dosing phase of the auto-injector 10, the dosing rim 22, drive chassis 24, and plunger 26 are in the syringe window 14.

Figure 2b shows the second portion of the outer surface 52 of the drive chassis within the status indicator window 20.

In the figures above, the status indicator window 20 on the side of the auto-injector 10 indicates the device status in a clear binary manner, which is likely to be very useful to the unsophisticated user. Before administration (and possibly during administration), the color displayed through the window is printed on the drive chassis 24 (see also FIG. 3). At the end of administration, the molded color (indicated by a hashed line) of the drive chassis 24 is displayed through the status indicator window 20. Other display configurations are possible, such as using a graphic to indicate that administration is in progress, an icon, or text.

Furthermore, prior to administration, the administerable fluid volume of medication M is clearly visible through syringe window 14, which is formed as a large curved window in housing 12. The geometry of this window 14 is intended to maximize the viewing angle for the user.

Since the movement of the plunger 26 and drive chassis 24 is visible through the syringe window 14, the progress of the administration can also be viewed through the window 20.

At the end of administration, the syringe window 14 is blocked by the drive chassis 24 and plunger 26 to provide an additional visual indication that the auto-injector 10 has been used. This means that there are two different visual indications of end of medication. The portion of the drive chassis 24 visible through the syringe window 14 can include surface decoration or indicia, for example, printed in a different color to provide an additional visual communication of end of administration.

FIG. 3 shows the drive chassis 24. The drive chassis 24 includes a dosing rim 22 and a trigger rim 32. The trigger rim 32 and the dosing rim 22 are arranged parallel to one another. The drive chassis 24 is a component configured to move in a straight line within the housing to expel the medication M from the prefilled syringe upon actuation of the automatic injector 10.

The trigger rim 32 and the dosing rim 22 are each at least approximately U-shaped and connected to one another via a web 42 at the distal end 38 of the drive chassis 24, i.e., axially displaced from one another in the transverse direction T, with the length of the trigger rim 32 being greater than the length of the dosing rim 22.

In this regard, it should be noted that in other designs, the dosing rim 22 may have the same length as the trigger rim 32 or may be longer than the trigger rim 32.

A plunger support 44 is disposed at the end of the dosing rim 22 remote from the web 42. The plunger support 44 is configured to engage the plunger 26 moving through the prefilled syringe 16, i.e., the plunger support 44 is configured to act on the prefilled syringe 16 of the autoinjector 10 via the plunger 26 disposed within the prefilled syringe 16.

The trigger arm 36 is configured to extend proximally beyond the trigger rim 32 in both the transverse direction T and the radial direction R relative to the axial direction A, which extends parallel to the trigger rim 32. The trigger arm 36 is positioned to extend from the trigger rim 32 in a direction away from the distal end 38.

The trigger arm 36 is fixedly attached to the trigger rim 32 and is movable relative to the trigger rim 32.

The trigger arm 36 is connected to the trigger rim at a position corresponding to the length of the trigger rim 32, which corresponds to 20-80% of the length of the trigger rim 32 from the distal end 38.

In this regard, it should be noted that the drive chassis 24 is formed in one piece, i.e. the trigger rim 32, the dosing rim 22, the plunger support 44 and the trigger arm 36 are preferably formed in one piece and integrally from one and the same material, for example in the same injection mould or in one production cycle if manufactured by additive manufacturing techniques.

The drive chassis 24 may be mounted to the auto-injector 10 shown in connection with Figures 1 and 2. The drive chassis 24 may then be linearly guided within the housing 12 of the auto-injector 10 as the auto-injector 10 moves from a storage stage to an administration stage of the auto-injector.

For this purpose, the drive chassis 24 may have first and second guide auxiliaries 46, 48 that cooperate with corresponding structures present in the housing 12. In this example, the first and second guide auxiliaries 46, 48 are formed by first and second grooves 46', 48', respectively, extending in the axial direction A along the dosing rim 22 at the trigger rim 32, respectively. The first and second grooves 46', 48' cooperate with lugs 164, 228 (see, for example, Figs. 10a and 13g, respectively), present on the inner wall of the housing 12.

Alternatively, the drive chassis 24 may include lugs as the first and second guide aids 46, 48 that cooperate with corresponding grooves in the housing 12.

Alternatively, the trigger rim 32 and the dosing rim 22 may be shaped to cooperate with a guide structure present in the housing 12, for example the trigger rim 32 and the dosing rim 22 may have a rounded profile in a cross section taken perpendicular to the axial direction A, the rounded profile of the trigger rim 32 and the dosing rim 22 therefore being guided in a complementarily shaped portion of the housing 12.

In the retraction phase, the trigger arm 36 is held by the stop mechanism 54 (see, for example, FIG. 4a). When moving the auto-injector from the retraction phase to the administration phase of the auto-injector, the trigger arm 36 is deflected out of engagement with the stop mechanism 54. To this end, the trigger arm 36 is movable relative to the trigger rim 32, i.e. the position of the trigger arm 36 can be moved relative to the trigger rim 32.

In this regard, it should be noted that the stop mechanism 54 is disposed at a height along the axis A of the housing 12 that corresponds to 45% of the length of the housing 12 from the distal end 30 of the auto-injector 10.

In this regard, it should be noted that the stop mechanism 54 can be positioned at a height along the axis A of the housing 12 selected from the distal end 30 of the auto-injector 10 within a range of 30-70% of the length of the housing 12.

In this regard, it should be noted that the trigger arm 36 is configured to move radially in a radial direction R and transversely in a transverse direction T relative to the trigger rim 32.

Trigger rim 32 has an outer surface 49 including a first partial outer surface 50 (a hashed surface) and a second partial outer surface 52 (a black outer surface). First partial outer surface 50 and second partial outer surface 52 lie in a transverse plane of trigger rim 32, i.e., a transverse plane pointing in transverse direction T. First partial outer surface 50 and second partial outer surface 52 are visible through status indicator window 20 during different stages of use of auto-injector 10.

Specifically, as shown in FIG. 1b, the first portion outer surface 50 is visible through the status indicator window 20 during the retraction phase of the auto-injector 10, and the second portion outer surface 52 is visible through the status indicator window 20 during the administration phase toward the end of the dose, and during the lockout phase of the auto-injector 10 following the end of the dose.

The first rim of the U-shaped drive chassis 24 is formed by the dose rim 22, and the second rim of the U-shaped drive chassis 24 is formed by the trigger rim 32.

The distal end of the syringe window 14 is disposed at approximately the same height as the distal end of the status indicator window 20. The syringe window 14 and the status indicator window 20 are disposed in a portion of the housing 12 where the inner body 80 and the outer body 82 (see FIG. 4) overlap. A third portion of the drive chassis 24 that may be visible in the syringe window 14 is the dosing rim 22, in addition to which the plunger 26 of the prefilled syringe 16 is also visible.

In this regard, it should be noted that the first portion 50 and the second portion 52 of the drive chassis 24 are not visible in the syringe window 14.

The first and second partial outer surfaces 50 and 52 have different appearances, i.e., they are distinct from each other, so that a user (not shown) can distinguish between different stages of use, i.e., the first and second partial outer surfaces 50 and 52.

In this example, the second portion outer surface 52 includes printed indicia in the form of hash structures, although other types of surface decorations and/or indicia may be used. The first portion outer surface 50 is formed, for example, in the same color as the rest of the drive chassis 24, but may also have some other color with some form of surface indicia and/or decoration, or other form of visual indicator.

By way of example, words such as "FULL AND/OR READY" and "EMPTY AND/OR USED" may be printed on the first portion outer surface 50 and the second portion outer surface 52. Additionally and/or alternatively, the first portion outer surface 50 and the second portion outer surface 52 may be colored differently from one another, such as red or green.

The auto-injector 10 shown in Figures 4a-4c includes a needle guard 18, a removable cap (Figure 4a only), a pre-filled syringe 16 disposed within the housing 12, a drive spring 74, a lockout spring 76, and a removable needle shield 78 (RNS).

Figure 4a shows the auto-injector 10 of Figure 1a in a storage stage, Figure 4b shows the auto-injector 10 of Figure 1a in an actuation stage immediately prior to the administration stage, and Figure 4c shows the auto-injector 10 of Figure 1a in a lockout stage.

During the storage phase of the auto-injector 10, the cap 70 is placed on the proximal end 28 of the auto-injector 10. Removal of the cap 70 allows access to the needle guard 18 of the auto-injector 10.

The needle guard 18 is axially movably mounted within the housing 12 for movement between the retraction, administration, and lockout phases. The needle guard 18 assumes a different axial position relative to the housing 12 during each of the retraction, administration, and lockout phases.

As shown in FIG. 4b, the needle guard 18 is moved distally along the axis A to make the needle 34 externally accessible, i.e., so that the patient can insert the needle 34 into his or her skin.

As the patient moves the auto-injector 10 toward the injection point, the needle guard 18 can automatically move distally along the axial direction A as contact with the patient's skin automatically moves the needle guard into the housing 12 of the auto-injector 10. To this end, the needle guard 18 is configured for axial movement distally between the retraction and administration phases.

When moving the needle guard from the retracted position to the administration position, the lockout spring 76 is biased between the needle guard 18 and the inner body 80 of the housing 12.

When medication M is administered, i.e., dispensed from the auto-injector 10, the needle guard 18 is configured to move axially proximally between the administration stage and the lockout stage upon removal of the auto-injector 10 from the injection site. This movement of the needle guard 18 is accomplished automatically by relaxation of the lockout spring 76.

The housing 12 is a two-part housing formed of an inner body 80 and an outer body 82 that are fixed in position relative to each other and snap-fit together via a connection 72.

As shown in FIG. 4b, the connection 72 is formed by a nose 188 formed on the inner body that is configured to hook into a window 190 formed in the outer body 82.

In this regard, it should be noted that the connection 72 can also be made via different types of connections. For example, the nose 188 can be formed in the outer body 82, protrude toward the inner body 80, engage the window 190, and then be formed in the inner body 80, or a different form of connector can be used to make the connection 72.

Trigger arm 36 is actuated by needle guard 18 of auto-injector 10 as auto-injector 10 moves from the retracted phase of auto-injector 10 to the dispensing phase of auto-injector 10. As can be seen by comparing Figures 4a and 4b, trigger arm 36 is biased in transverse direction T. Additionally, trigger arm 36 is also biased in radial direction R.

The drive spring 74 is disposed within the housing 12 of the auto-injector 10. Specifically, the drive spring 74 is disposed between the distal housing wall 84 and the drive chassis 24. More specifically, the drive spring 74 is disposed between the distal housing wall 84 of the outer body 82 and within the trigger rim 32 of the drive chassis 24. To fix the position of the drive spring 74, it may be disposed on a protrusion 86 that protrudes proximally from the distal housing wall 84 of the outer body 82.

The drive spring 74 is received within a passage 140 formed in the trigger rim 36 of the drive chassis 24. This means that the trigger rim 36 is configured to receive the drive spring 74. In this example, the passage 140 has a cylindrical shape that is complementary to the outer shape of the drive spring 74.

As can be seen by comparing Figures 4a and 4b with Figure 4c, the drive spring 74 is relaxed in the lockout stage compared to the other two stages. This is because disengagement between the trigger arm 36 and the stop mechanism 54 allows the drive chassis 24 to move proximally relative to the housing, i.e., relative to the inner and outer bodies 80, 82, with the previously biased drive spring 74 relaxed.

The drive spring 74 also biases the trigger arm 36 during the retraction phase of the auto-injector 10 against the housing 12 of the auto-injector 10 by pressing against the stop mechanism 54 using the inherent spring bias of the drive spring 74.

The drive spring 74 is further configured to push the plunger support 44 of the drive chassis of the automatic injector 10 into the pre-filled syringe 16. This is due to the fact that the drive chassis 24 is linearly guided within the housing 12 and is allowed to move in a proximal direction when the trigger arm 36 is released from engagement with the stop mechanism 54.

The needle guard 18 surrounds the needle 34 of the prefilled syringe 16 during the storage and lockout phases. When the cap 70 is removed and the auto-injector 10 is moved to the administration phase, the needle guard 18 no longer surrounds the needle 34 of the prefilled syringe 16.

As shown in Figures 4a-4c, the auto-injector 10 further includes a lockout spring 76 disposed between the needle guard 18 and the housing 12, more specifically between the inner body 80 and the needle guard 18.

The lockout spring 76 is biased between an end wall 88 of the needle guard 18 and a proximal end 92 of the inner body 80. The end wall 88 is disposed proximally relative to the inner body 80 and the drive chassis 24.

Further, the needle guard 18 includes a protrusion 90 that protrudes distally from the proximal end 28. The lockout spring 76 is disposed on the protrusion 90, and in particular, the protrusion 90 protrudes into the lockout spring 76.

The needle guard 18 is configured to compress the lockout spring 76 as it moves between the retraction and administration stages. This is possible because the lockout spring 76 abuts against the proximal end 92 of the inner body 80 of the auto-injector 10 and the protrusion 90 is guided through an aperture 91 present in the inner body 80.

After the auto-injector 10 has been used and is removed from the injection site, the needle guard 18 is configured to move proximally between the administration phase and the lockout phase due to relaxation of the lockout spring 76.

In this connection, it should be noted that the projection 90 can also be provided on the inner body 80 so as to project towards the proximal end 28 of the needle guard 18. If this option is chosen, the length of the projection 90 should be adapted so that it does not impede the needle guard from moving in the distal direction and/or does not project beyond the needle guard 18 during the administration phase and come into contact with the patient's skin, for example when cooperating with an aperture (not shown) of the needle guard 18.

During the retraction phase of the auto-injector 10, the needle guard 18 is disposed in a first axial position. During the administration phase, the needle guard 18 is disposed in a second axial position, and during the lockout phase, the needle guard 18 is disposed in a third axial position. The first, second, and third axial positions are each different from one another, the third axial position is proximal to the first and second axial positions, and the first axial position is proximal to the housing 12 relative to the second axial position.

In this regard, it should be noted that in other designs of the auto-injector 10, the third axial position may be the same as or very similar to the first axial position.

This means that the external length of the auto-injector 10 with the cap 70 removed is longest in the lockout phase, shortest in the administration phase, and intermediate in the retraction phase.

Figure 5a shows a perspective view of the removable cap 70. The cap 70 is of a single piece design. The needle guard 18 is configured to cooperate with the cap 70 via one or more snap-fit connections 94, each of which includes a protruding edge 96 (see, e.g., Figure 6) that cooperates with a corresponding snap-fit area 98.

In this regard, it should be noted that each of the following components, namely, outer body 82, inner body 80, drive chassis 24, needle guard 18, cap 70, and/or needle shield 78, may each be integrally formed in one piece, preferably from one and the same material, e.g., in the same injection mold.

As shown in FIG. 5a, the removable cap 70 has a base 100. The cap 70 tapers outwardly in the region of the base 100 such that the base 100 of the cap 70 has a larger outer diameter than the remaining cap 70 portions. This is particularly beneficial since the base 100 can act as a stand for the auto-injector 10 during the storage phase of the auto-injector 10.

The needle guard facing end 102 of the cap 70 includes a needle shield holder 104 at the end of the cap 70 disposed opposite the base 100. The needle shield holder 104 is configured to hold a removable needle shield 78 that covers the needle of the pre-filled syringe 16 during the storage phase of the auto-injector 10.

The inner wall 106 of the needle shield holder 104 further includes two windows 112. A respective one of the inwardly facing protrusions 108 is disposed in each of the windows 112.

Two recesses 114 are formed in the inner wall 106 of the needle shield holder 104 of the cap 70. The recesses are disposed between the respective portions of the needle shield holder 104 having windows 112.

The needle shield holder 104 projects distally from the base 100 of the cap 70 and is surrounded by the outer wall 116 of the cap 70. The inner surface 118 of the outer wall 116 of the cap 70 includes a number of ribs 120.

As shown in FIG. 5b, the front end 122 of the needle guard 18 is disposed within an opening 124 in the cap 70. The opening 124 is formed between the outer wall 116 of the cap 70 and the needle shield holder 104.

The ribs 120 are configured to press radially inward, i.e., in the radial direction R, and transversely inward, i.e., in the transverse direction T, against the needle guard 18 during the retraction phase of the automatic injector 10.

As also shown in FIG. 5b, the removable needle shield 78 is disposed within the needle shield holder 104. For this reason, the inner wall 106 of the needle shield holder 104 is provided with an inwardly facing protrusion 108 at the needle guard facing end 102 which engages the syringe facing surface 110 of the needle shield 78.

As shown in FIG. 6, the raised edge 96 is provided on the outer surface 126 of the needle guard 18. The snap-fit area 98 is provided on the inner surface 118 of the cap 70.

The snap-fit connection 94 holds the cap 70 in place during the retraction phase of the auto-injector. The cap 70 is removably connected to the needle guard 18 such that when the cap 70 is removed, the needle shield 78 is also removed from the auto-injector 10 as the cap projections 108 bear against the syringe-facing surface 110 of the removable needle shield 78, pulling the removable needle shield in a proximal direction as the cap 70 is removed.

In order to allow for a design of the automatic injector 10 that is as compact as possible, the inner surface 128 of the outer body 82 is provided with a groove 130 in which one of the protruding edges 96 can move axially relative to the outer body 82 when the needle guard 18 moves axially.

Similarly, the inner surface 132 of the inner body 80 includes a further groove 134 within which a further one of the protruding edges 96 can move axially relative to the inner body 80 as the needle guard 18 moves axially relative to the housing 12.

The snap-fit protrusions 96 thereby form a detent mechanism on the needle guard 18 that engages with a corresponding mechanism on the cap to provide a tight axial fit between the components after assembly.

The reverse arrangement of the detent mechanism may also be possible, for example, a snap-fit area may be present on the housing 12 and a corresponding snap-fit protrusion may be present on the cap 70.

The proximal side of these detent mechanisms (snap-fit protrusions 96) on the needle guard are relatively steep, i.e., the proximal side of the snap-fit protrusions 96 is steeper in the axial direction than the distal side of the snap-fit protrusions 96, so that once the cap 70 is removed, if the user attempts to reinstall it, the force attempting to re-engage the detent mechanisms is great enough to move the needle guard 18 distally until the detent mechanisms are hidden within the housing 12.

In this manner, reattachment of the detent mechanism is not possible (although the cap may be held in place by engagement of the RNS 78 and the syringe glass). Attempting to reattach the cap 70 in this manner will not trigger a dose, as the distance the needle guard 18 is moved to hide the detent mechanism is designed to be less than the distance required to trigger a dose.

When the cap 70 is attached to the auto-injector 10, i.e., to the needle guard 18 via the snap-fit connection 94, the cap 70 prevents the needle guard 18 from moving axially when attached to the needle guard 18 during the retraction phase.

As further shown in FIG. 6, in the retracted phase of the automatic injector 10, the outer wall 116 of the cap 70 contacts the outer wall 136 of the housing 12. The outer wall 116 of the cap 70 and the outer wall 136 of the housing 12 do not overlap in the axial direction A of the automatic injector 10. Furthermore, the outer wall 116 of the cap 70 and the outer wall 136 of the housing 12 overlap radially in the retracted phase of the automatic injector 10.

In this regard, it should be noted that the outer wall 136 of the housing is the outer wall 136 of the outer body 82 that forms part of the two-part housing 12.

A clip mechanism in the form of a protrusion 108 on the cap 70 acts on the distal surface of the rigid needle shield (RNS) 78 to grip the needle shield and remove it from the prefilled syringe 16 when the cap 70 is removed by the user.

In this regard, it should be noted that whereas state of the art devices typically build similar caps from two or more separate components in a common injection mold (not shown), a "three-plate tool" structure may be used to mold cap 70, including the clip mechanism (protrusion 108) of a single component.

The protrusions 108 are supported by the needle guard 18 during removal of the needle shield 78 and help prevent the needle shield holder 104 from spreading outward and disengaging as it is urged radially inward by the needle guard 18.

Figures 7a-7c show partial cross-sectional views of the auto-injector 10 with portions of the housing 12 removed to reveal the needle guard 18, the drive chassis 24, the pre-filled syringe 16, and components of the housing 12 as the auto-injector 10 is actuated.

These figures show how the release mechanism 40, including the trigger arm 36 and stop mechanism 54, is engaged prior to distal movement of the needle guard 18 into the housing 12, which in turn moves the drive chassis 24 proximally to administer the medication M contained in the prefilled syringe 16.

The needle guard 18 includes a plunger arm 142 that is part of the release mechanism 40 of the auto-injector 10. The plunger arm 142 extends distally from the front end 122 of the needle guard 18.

As can be seen, the relative position of the plunger arm 142 with respect to the housing 12 varies and the distance that the needle guard 18 protrudes beyond the housing 12 at the proximal end 28 is reduced between Figures 7a and 7c.

Figures 8a-8c show detailed views of different positions of the release mechanism 40 of the auto-injector 10 corresponding to the views shown in Figures 7a-7c.

Figure 8a shows a close-up view of the components of the release mechanism 40 of the auto-injector 10, including the trigger arm 36 of the drive chassis 24 and the stop mechanism 54 present in the opening 138 in the housing 12 with which the trigger arm 36 cooperates.

In this regard, it should be noted that the opening 138 in the housing 12 is shown as a through opening, i.e., opening in both the outer wall of the housing 12 as well as the inner wall of the housing 12. However, it should be noted that the opening 138 may also be formed as a recess in the inner wall of the housing 12 so as not to penetrate the wall of the housing 12.

The drive chassis 24 is mounted to the housing 12 and biased against the housing 12 via a drive spring 74. The drive chassis 24 is further fixed to the housing 12 and moves against the housing 12 during the retraction phase of the automatic injector 10 via a trigger arm 36 held in an opening 138.

During the retraction phase of the auto-injector 10, the drive spring 74 biases the trigger arm 36 in the axial direction A against the stop mechanism 54. The trigger arm 36 resides to the right within the opening 138 (as viewed in this figure).

To activate the auto-injector 10 and release the drive chassis 24 from its proximal movement, the auto-injector 10 includes a release mechanism 40.

The release mechanism allows relative movement between the needle guard 18 and the drive chassis 24. This relative movement is accomplished by axial movement of the needle guard 18 toward the drive chassis 24, thereby releasing the lock of the drive chassis 24 from the housing 12 when the auto-injector 10 is actuated.

To this end, the plunger arm 142 is configured to cooperate with the trigger arm 36 of the drive chassis 24 to actuate the release mechanism 40. When the plunger arm 142 is moved distally, it contacts the trigger arm 36, thereby deflecting the trigger arm 36 in a transverse direction T indicated by arrow B. A comparison of the position of the trigger arm 36 relative to the opening 138 is shown in Figures 8a-8c.

The plunger arm 142 of the needle guard 18 includes a blocking rib 144. The blocking rib 144 is configured to block radial movement of the trigger arm 36 when the plunger arm 142 contacts the trigger arm 36.

In this regard, it should be noted that the blocking rib 144 is also configured to block radial movement of the trigger arm 36 during the retraction phase before axial movement of the needle guard 18 causes the plunger arm 142 to contact the trigger arm 36.

To engage the trigger arm 36, the plunger arm 142 includes a cam 162. The cam 162 has an engagement surface 146 configured to engage the trigger arm 36. The engagement surface 146 protrudes from the cam 162 of the plunger arm 142 at a location adjacent the block rib 144 in the transverse direction T, facing the trigger arm 36.

Trigger arm 36 includes a web 148. Web 148 extends axially (proximally) from trigger arm 36 below projection 154 and provides a contact surface in the transverse direction T facing cam 162 of plunger arm 142 for engaging cam 162 after needle guard 18 is moved axially (distally).

When the needle guard 18 is moved distally, the engagement surface 146 engages the web 148. This means that the web 148 and the engagement surface 146 are provided to further facilitate contact between the trigger arm 36 and the plunger arm 142.

In an embodiment not shown, the web 148 may include a deflection surface 150 that is inclined relative to the trigger arm 36 with respect to the axial direction A, i.e., the direction of movement of the drive chassis 24.

In this regard, it should be noted that the deflection surface 150 may be inclined with respect to the axial direction A at an angle selected in the range of 0 to 40°, in particular in the range of 5 to 35°, and most preferably in the range of 10 to 30°.

Engagement surface 146 may also be angled relative to the direction of travel of drive chassis 24, i.e., axis A. Engagement surface 146 is angled to gradually deflect trigger arm 36 in a direction transverse to axis A along which needle guard 18 travels to shift trigger arm 36 from the right side of opening 138 in FIG. 8a to the left side of opening 138 in FIG. 8c.

In this regard, it should be noted that the engagement surface 146 may be inclined relative to the trigger arm 36 at an angle selected in the range of 5 to 50°, particularly in the range of 7 to 30°, and most preferably in the range of 8 to 20°.

In this regard, it should be noted that the engagement surface 146 and the web 148 are positioned facing each other in a cooperative manner.

When the engagement surface 146 contacts the respective deflection surface 150 of the web 148, the trigger arm 36 is configured to move, and in particular disengage, from the stop mechanism 54 through deflection in the direction of arrow B.

The opening 138 in which the stop mechanism 54 is disposed includes a surface 152 having a convex shape. The trigger arm 36 is configured to cooperate with the convex surface 152 of the stop mechanism 54.

To this end, the trigger arm 36 includes a protrusion 154 that engages the stop mechanism 54. The protrusion 154 is configured to cooperate with the opening 138 by engaging in this manner and by resting on the surface 152 of the stop mechanism 54 at least during the retraction phase of the automatic injector 10.

The web 148 is disposed on a surface of the trigger arm 36 that is different from the surface on which the protrusion 154 of the trigger arm 36 is disposed. The protrusion 154 is disposed to protrude radially from the trigger arm 36, and the web 148 is disposed to protrude transversely from the trigger arm 36.

Figure 8c shows the stage where the engagement surface 146 of the blocking rib 144 of the plunger arm 142 has been moved distally in the axial direction A beyond the axial position of the protrusion 154, and the trigger arm 36 has been deflected transversely in the direction T toward the left side of the opening 138 and radially inwardly in the radial direction R out of engagement with the stop mechanism 54.

Figure 8c shows the needle guard 18 moving distally relative to the previous view, i.e., the trigger arm 36 has disengaged from the stop mechanism 54, so that the auto-injector 10 is shown in the administration phase just before the drive spring 74 biases the drive chassis 24 proximally in the axial direction A.

Figure 9a shows a front view of the opening 138 of Figure 8b, with the protrusion 154 located at the apex 160 of the surface 152.

As discussed above, the stop mechanism 54 includes a convex surface 152 formed by a first planar surface 156 and a second planar surface 158 that are inclined relative to one another. The first planar surface 156 and the second planar surface 158 abut one another at an apex 160 formed therebetween.

In this connection, it should be noted that the inclination angle between the first flat surface 156 and the second flat surface 158 is selected in the range of 110 to 175°, preferably in the range of 120 to 170°, in particular in the range of 130 to 165°.

In this connection, it should further be noted that the angle between the first flat surface 156 and the axial direction A is selected in the range of 0 to 50°, in particular in the range of 1 to 30°, and most preferably in the range of 2 to 20°.

In this regard, it should be further noted that the angle between the second flat surface 158 and the axial direction A is selected in the range of -20 to 20°, in particular in the range of -10 to 10°, and most preferably in the range of -5 to 5°.

The apex 160 defines the overhaul angle that the trigger arm 36 faces upon actuation of the auto-injector 10 to shift the auto-injector 10 from the retraction stage to the administration stage.

In this regard, it should be noted that the faces of the trigger arm may preferably be inclined and angled such that the inclination and angle match the angle and inclination of the first planar surface 156 and the second planar surface 158. In this manner, the contact area between the first planar surface 156 and the second planar surface 158 can be maximized to improve the fit between the respective surfaces, particularly during the retraction phase.

Figure 9a) shows a first view of the release mechanism 40 with the trigger arm 36 of Figure 8 cooperating with the stop mechanism 54. Figure 9b) shows a second view of the release mechanism 40, specifically a view orthogonal to that shown in Figure 9a, showing the cooperation of the trigger arm 36 and the stop mechanism 54.

During the retraction phase, the blocking rib 144 is configured to block radial movement of the trigger arm 36 by forming a wall against which the trigger arm 36 abuts if the trigger arm 36 is forced radially inward in an unacceptable manner, e.g., from outside the opening 138 when the plunger arm 142 contacts the trigger arm 36.

During this retraction phase, the drive spring 74 urges the drive chassis 24 in the axial direction A, and the drive chassis 24 is axially held in position in the opening 138 via the projection 154 of the trigger arm 36.

More specifically, the projection 154 is, so to speak, held within the acute space formed by the first flat surface 156 of the stop mechanism at the opening in relation to moving the trigger arm 36, which must not only move in the transverse direction T but also move distally in the axial direction A.

When the automatic injector 10 is moved from the retracted stage to the administration stage, the needle guard 18 is moved toward the drive chassis 24, causing the plunger arm 142 to deflect the trigger arm 36 via the engagement surface, i.e., via the deflection surface 150 of the web 148, in the axial direction A by lifting the web 148 distally in the axial direction A, and to push the web 148 transversely in the transverse direction T.

When the projection 154 of the trigger arm 36 passes the apex 160, the spring force of the drive spring 74 causes the drive spring 74 to relax, urging the drive chassis 24 proximally in the axial direction A, disengaging the trigger arm 36 from the opening 138, for example, as shown in FIG. 8c or as shown in FIG. 4c.

In addition, as the plunger arm engagement surface 146 deflects the trigger arm 36 in the transverse direction T, it can also deflect it radially inward in the radial direction R. As shown in FIG. 4b, this causes the transverse deflection of the trigger arm 36 by the engagement surface 146 to disengage the trigger arm 36 when engaged with the blocking rib 144 of the plunger arm 142, thereby allowing the trigger arm to deflect radially inward in the radial direction R past the blocking rib 144.

Prior to administration, the trigger arm 36 of the drive chassis 24 is actuated into engagement with the axial stop mechanism 54 on the outer body 82 of the housing 12.

When an axial force from drive spring 74 is acting on drive chassis 24, trigger arm 36 is prevented from moving laterally or radially inwardly by the following.
a negatively inclined contact surface 156 on the outer body 82 of the housing 12;
- opposing friction,
the angle of the trigger arm 36, and the stiffness of the trigger arm 36.

In this regard, it should be noted that this geometry may require a slight lift of the drive chassis 24 and therefore a slight compression of the drive spring 74 to disengage the trigger arm 36. However, sufficient robustness (i.e., protection against false triggering) may be achieved simply by a combination of the load and coefficient of friction between the surface of the stop mechanism 54 and the trigger arm 36 upon contact. If the coefficient of friction is high enough, even a negatively sloped retaining surface (opposite side from that shown in the figure) may work.

Blocking ribs 144 on the needle guard 18 also prevent the trigger arm 36 from moving radially inward. It would be feasible to add additional blocking rib features (not shown) to the needle guard to prevent transverse movement of the trigger arm 36. These transverse blocking rib features would be positioned to axially disengage from the trigger arm 36 during the initial displacement of the needle guard 18 upon actuation, releasing the transverse movement of the trigger arm 36.

Figure 8a shows the retracted position of the release mechanism 40 during the retraction phase. The administration process is triggered by pressing the needle guard 18 against the user's skin so that it is displaced distally relative to the outer body 82 of the housing 12.

The angled engagement surface 146 of the cam 162 of the needle guard 18 contacts the trigger arm 36 and translates its projection 154 laterally past the apex 160 of the stop mechanism 54 on the outer body 82 of the housing 12.

As the projection 154 of the trigger arm 36 passes the apex 160 of the stop mechanism 54, it engages the steeper slope of the second flat surface 158, which, under the action of the drive spring 74, continues to deflect the trigger arm 36, eventually disengaging the stop mechanism 54 radially as well, without further contact with the needle guard 18.

Figure 8b shows the release mechanism 40 at the time of triggering, and in one optional embodiment, after a short transverse movement, the trigger arm 36 moves the outer body 82 further radially inward until it contacts the angled surface and is fully disengaged from the stop mechanism 54.

In an alternative embodiment, the cross-sectional profile of the trigger arm 36 tends to create radial movement of the protrusion 154 (enabling disengagement) as the arm 36 is moved laterally.

Once fully disengaged, the drive chassis 24 advances toward the prefilled syringe 16 and engages the plunger 26, administering the medication M under the action of the drive spring 74.

Figure 8c shows the release mechanism 40 in the released position. The overhauled convex surface 152 of the stop mechanism 54 on the outer body 82 of the housing 12 and the radial retraction of the trigger arm 36 increases the contact area subjected to the axial load (thereby minimizing stress for a given drive spring 74 force) while at the same time requiring a shorter transition for triggering. This shorter transition for triggering tends to reduce the required user trigger force input, with the drive spring 74 actually contributing a larger portion of the trigger energy.

Figure 10a shows a diagram of the position of the needle guard 18 of the auto-injector 10 relative to the inner body 80 of the housing 12 during the retraction phase of the auto-injector 10. Figure 10b shows a diagram of the position of the needle guard 18 of the auto-injector 10 relative to the housing 12 during the lockout phase.

The drive chassis 24 is similarly inserted into the inner body 80. The inner body 80 includes a lug 164 that cooperates with the second groove 48' of the drive chassis 24 as a second guide aid 48 that allows the drive chassis 24 to be linearly guided within the inner body 80 of the housing 12.

The needle guard 18 has a protrusion 166 that cooperates with an elongated hole 168 present in the inner body 80 to ensure linear guidance of the needle guard 18 relative to the inner body 80.

The needle guard 18 further includes a retaining mechanism 170. The retaining mechanism 170 is configured to prevent removal of the needle guard from the proximal end of the housing 12.

To this end, the slot 168 includes a proximal stop 172 that prevents the projection 166 from moving proximally beyond the stop 172, and thus the stop 172 acts as a retention mechanism 170 for the needle guard 18.

In this regard, it should be noted that the elongated hole 168 is dimensioned to be complementary to the shape of the protrusion 166 and to define the linear range of movement of the needle guard 16 relative to the inner body 80.

This means that the width of the elongated hole 168 perpendicular to the axial direction A may be selected to be complementary to the width of the protrusion perpendicular to the axial direction A.

Furthermore, the length of the slot 168 between the proximal stop 172 and the distal stop 192 parallel to the axial direction A may be selected to correspond to the range of axial movement of the needle guard 18.

The inner body 80 further includes a first notch 174. The first notch 174 is configured to cooperate with a clip arm 184 and a lockout arm 186 of the needle guard 18.

Specifically, as shown in FIG. 10a, the clip arm 184 is configured to cooperate with the first portion 180 of the first notch 174, and the lockout arm 186 is configured to cooperate with the second portion 182 of the first notch 174.

The first portion 180 and the second portion 182 of the first notch each have a rectangular shape, are directly adjacent to each other, and are offset relative to each other along the axial direction A.

The inner body 80 further includes a second notch 176 axially disposed adjacent the first notch 174 and separated from the first notch 174 by a bar 178. The second notch 176 is configured to cooperate with a lockout arm 186.

In this regard, it should be noted that the second notch is configured to cooperate only with the lockout arm 186 and therefore not with the clip arm 184. This is made possible by the offset between the first portion 180 and the second portion 182.

In this regard, it should be further noted that the lockout arm includes an engagement portion 220 configured to engage with a corresponding notch 176.

In the illustrated embodiment, the engagement portion 220 has a ramp 222 through which it can pass over the bar 178 when moving proximally from the first notch 174 to the second notch 176, and a flat portion 224 configured to fall into the second notch 176 and then act as an abutment to prevent the needle guard 18 from moving distally past the bar 178 out of the lockout stage.

As shown, the first notch 174 may be on the same side of the inner body 80 as the elongated hole 168. The first notch 174 may also be on a different side than the side on which the elongated hole 168 is located. Furthermore, two first notches 174 and/or two elongated holes 168 can be provided and located on oppositely disposed sides of the inner body 80 (see, e.g., FIG. 14).

As also shown in Figures 10a and 10b, a nose 188 of the connection 72 resides in the inner body 80. The nose 188 cooperates with a window 190, shown for example in Figure 4, to form the connection 72.

The function of the needle guard 18 prior to administration is as follows.
The needle guard spring, or lockout spring 76 (biased against the inner body 80) exerts a proximal force on the needle guard 18. The needle guard 18 is axially retained within the inner body 80 by its clip arms 184. The needle guard lockout arms 186, with play against the inner body, avoid long term creep that could subsequently affect the robustness of the lockout.

When the needle guard 18 is pressed by the user during administration, the clip arm 184 moves upward within the first notch 174 of the inner body 80, more specifically within the first portion 180 of the first notch 174. As the drive chassis 24 approaches the end of its administration stroke (but before the end-of-dose click (see FIG. 11 ) to avoid associated losses that coincide and reduce the minimum output force from the drive chassis 24), the drive chassis 24 contacts the chamfered surface 226 of the clip arm 184 of the needle guard 18, thereby deflecting and holding the clip arm 184 radially inward. The chamfered surface 226 assists in deflecting the clip arm 184 in the radial direction R.

When the user removes the needle 34, and thereby the needle guard 18, from the skin, the needle guard 18 extends linearly proximally under the action of the lockout spring 76. The clip arm 184 is biased radially inward by the drive chassis 24 so that it does not engage the inner body assembly stop mechanism 194 during its return transition. Instead, the needle guard 18 continues to extend until its lockout arm 184 engages the bar 178 of the inner body 80 in the extended position, locking the needle guard 18 from moving distally. The bar 178 separates the first notch 174 from the second notch, and the lockout arm 184 is movable within the first notch 174 during and before use of the lockout of the needle guard 18.

In addition, during the lockout phase, the protrusion 166 engages the proximal end of the elongated hole 168 which acts as a retaining mechanism 170, thereby preventing the needle guard 18 from moving further in the proximal direction.

Figure 10b shows the extended position of the needle guard 18 after administration, with the lockout clip 186 engaging the bar 178. In the fully extended position, the lockout arm 186 of the needle guard 18 engages the bar 178 of the inner body 80, providing a mechanical lockout that resists collapse of the needle guard 18, thus protecting the user from the risk of needle stick injury.

Figure 11a) shows a diagram of the auto-injector 10 in the administration stage at the end of the dose, and b) shows an enlarged view of a portion of the auto-injector 10 in the administration stage at the end of the dose.

The trigger rim 32 further comprises at least a first portion 56 of an audible dose end feedback member 58 in the form of a click arm 56. The first portion 56, i.e., the click arm 56, is defined by a nose 60 formed at the end of a tongue 62 that projects from the trigger rim 32, the nose 60 optionally having a generally triangular profile.

The tongue 62 protrudes from the trigger rim 32 in the region of a recess 64 formed in the outer surface 49 of the trigger rim 32. The opening 68 of the recess 64 faces in the radial direction R.

The inner body 80 of the housing 12 further comprises at least a second portion 66 of the audible end-of-dosage feedback member 58 (see, e.g., FIG. 11b).

The second portion 66 of the audible dose end feedback member 58 includes a distal surface 196 and a proximal surface 198 that surrounds the inner body recess 206.

In this regard, it should be noted that the positioning of the first and second portions 56, 66 of the audible feedback member 58 can be reversed, i.e., the recess 206 can be provided on the drive chassis 24 and the tongue 62 can be provided on the inner body 80. It should also be noted that the drive chassis 24 and the inner body 80 can each have a first and second portion 56, 66, respectively, of the audible feedback member 58 that cooperates with the other first and second portions 56, 66, respectively, of the audible feedback member 58 provided on the other component, i.e., the inner body 80 has both a recess and a tongue that each cooperates with a respective one of the tongue and recess on the drive chassis 24.

During use of the auto-injector 10, the trigger rim 32 is moved axially A by the drive spring 74 during administration, which causes the first portion 56 of the audible end-of-dose feedback member 58 to be biased in a transverse direction T toward the drive spring 74.

This is accomplished when the inclined surface 200 of the end-of-dose feedback member 58 is deflected by the distal inner housing end 204 of the inner housing 80. This can be assisted because the distal inner housing end 204 may be chamfered toward the distal wall 84 of the housing 12.

The audible dose end feedback member 58 is configured to emit a sound when the substance is dispensed from the auto-injector, i.e., when the click surface 202 of the nose 60 attached to the latching tongue 62 engages the distal surface 196 of the inner body recess 206 by moving outward in the transverse direction T.

The positions of the first portion 56 and the second portion 66 of the audible feedback member 58 are selected so that an audible click occurs when the plunger 26 reaches or is close to reaching its final position within the prefilled syringe 16.

The audible dose completion feedback member 58 is thereby configured to emit a sound between the drive chassis 24 and the housing 12 when a substance is administered from the auto-injector 10.

Thus, as the end of the dose approaches, the nose 60 of the drive chassis 24 engages the ramp of the inner body 80, i.e., the chamfered distal inner housing end 204, which deflects the tongue 62 radially inward. Near the end of the transition, the nose 60 drops into the inner housing recess 206 of the inner body 80, quickly releasing its deformation and creating an audible click (either by contact with another component surface or simply by acceleration through the air).

Figures 12a-12f show various views of an example cap 70 for an auto-injector 10.

FIG. 12a shows a perspective view of the removable cap 70. The cap 70 is of a single piece design. The needle guard 18 is configured to cooperate with the cap 70 via one or more snap-fit connections 94.

Figures 12b and 12c show side views of the cap, showing section lines C:C, D:D, and E:E for the respective sections shown in Figures 12d-12f, respectively.

The window 112 shown in FIG. 12b has at least approximately a triangular shape with rounded edges.

The recesses 114 shown in FIG. 12c have the shape of slots with rounded edges and separate the windows 112.

In this regard, it should further be noted that by providing the window 112 in the needle shield holder 104, a respective tooling pull-in surface is also provided that allows the cap 70 to be ejected from the injection mold tool.

Figure 12d shows a cross section through the cap 70 taken along section line C:C in Figure 12b. The ribs 120 are provided on the inner surface 118 of the cap 70 only in areas where the needle shield holder 104 is not present within the cap 70.

As shown in the cross section shown in FIG. 12e, taken along the cross section line D:D in FIG. 12b, a space is visible within the needle shield holder 104 for receiving and holding a removable needle shield 78 that covers the needle of the prefilled syringe 16 during the retraction phase of the auto-injector 10.

The inner shape of the needle shield holder 104 is complementarily shaped to the outer shape of the removable needle shield 78 to aid in the most compact possible design of the cap 70 and to allow for reliable removal of the removable needle shield 78 when the cap 70 is removed from the automatic injector 10.

Furthermore, an opening 124 in the cap 70 is formed between the outer wall 116 of the cap 70 and the needle shield holder 104. The size of the opening is selected according to the size of the portion of the needle guard that is to be inserted into the opening during the retraction phase of the auto-injector 10.

The needle shield holder 104 projects distally from the base 100 of the cap 70 and is surrounded by an outer wall 116 of the cap 70. An inner surface 118 of the outer wall 116 of the cap 70 includes a number of ribs 120 that are configured to compress a front end 122 of the needle guard 18 when it is positioned within the opening 124.

As shown in the cross section shown in FIG. 12f, taken along section line E:E of FIG. 12c, the ribs 120 project inwardly into the opening 124 of the cap 70. The ribs 120 are distributed across the inner surface 118 to retain the front end 122 of the needle guard 18.

The inner wall 106 of the needle shield holder 104 further includes two windows 112, with one inwardly facing protrusion 108 disposed in each of the windows 112.

Two recesses 114 are formed in the inner wall 106 of the needle shield holder 104 of the cap 70. The recesses are disposed between the respective portions of the needle shield holder 104 having windows 112.

The snap-fit area 98 of the cap 70 is provided on the inner surface 118 of the cap 70, a first snap-fit area 208 is formed within some of the ribs 120 of the cap, and a second snap-fit area 210 is formed in an area of the cap 70 where there are no ribs 120.

The cap 70 is of a single piece design and the end face at the proximal surface of the cap 70 at the base 100 does not have any holes.

13a-13j show various views of an example of an outer body 82 of an auto-injector 10. 13a and 13b show two perspective views of the outer body 82, 13c-13f show side views of the outer body 82, 13g shows a cross section taken along section line C:C in 13f, 13h shows a cross section taken along section line D:D in 13e, and 13i shows a top view of the outer body 82.

Figure 13j shows a cross section taken along section line E:E of Figure 13e. A lug 228 configured to engage the second groove 48' forming the second guide aid 48 is visible on the inner surface 132 of the outer body 82.

In contrast to the embodiment shown in connection with the above figures, the outer body 82 includes two stop mechanisms 54, one on each side of the outer body 82 at each window 40, as shown in Figures 13a, 13c, and 13e.

Furthermore, a protrusion 86 protruding from the distal wall 84 of the outer body 82 of the housing 12 is visible in FIG. 13g. This is intended to be inserted into the passage 140 of the drive chassis 24 upon assembly of the auto-injector 10, and is therefore located in the same transverse position as the trigger rim 32 of the drive chassis 24.

In this regard, it should be noted that the drive chassis 24 is a component that may be configured to move in a linear fashion within the housing 12 to expel the medication M stored in the prefilled syringe 16 disposed within the housing 12 from the prefilled syringe 16 upon actuation of the automatic injector 10 by pulling the plunger 26 of the prefilled syringe 16.

Figures 14a-14j show various views of an example of an inner body 80 of an auto-injector 10. Figures 14a and 14b each show a perspective view of the inner body 80 from two sides. The distal housing end 204 with the recess formed therein is shown at the top of Figures 14a and 14b.

Figures 14c-f show side views of the inner body 80, Figure 14g shows a cross section taken along section line F:F of Figure 14e, Figure 14h shows a cross section taken along section line E:E of Figure 14f, Figure 14i shows a top view of the inner body 80, and Figure 14j shows a cross section taken along section line G:G of Figure 14e.

The inner body 80 is configured to cooperate with the outer body 82 of FIG. 13 and with the needle guard 18 shown in FIG. 15 below. The inner body 80 has two first notches 174, two second notches 176, and two elongated holes 168 located on oppositely disposed sides of the inner body 80 and configured to engage corresponding portions of the needle guard 18.

15a-15j show various views of an example of a needle guard 18 of an auto-injector 10, which is configured to cooperate with the inner body 80 of FIG. 14 and, to this end, comprises two projections 166 cooperating with respective ones of the elongated holes 168, two lockout arms 186 cooperating with respective ones of the first and second notches 174, 176 separated by a respective bar 178, and two respective clip arms 184 engaging with the respective first notches 174 and the trigger rim 32 of the drive chassis 24.

Furthermore, the needle guard 18 also includes a single plunger arm 142 having two blocking ribs 144 and two cams shaped in the manner described above. The blocking ribs 144 are configured to cooperate with the drive chassis 24, discussed in connection with FIG. 17, when inserted into the housing 12, which includes the outer body 82, discussed in connection with FIG. 13, and the inner body 80, discussed in connection with FIG. 14. It should also be noted that the blocking ribs 144 are located on opposite sides of the plunger arm 142.

15a and 15b respectively show perspective views from two sides of needle guard 18, 15c-15f respectively show side views of needle guard 18, 15g shows a cross section taken along section line D:D of FIG. 15e, 15h shows a cross section taken along section line E:E of FIG. 15f, 15i shows a top view of needle guard 18, and 15j shows a cross section taken along section line F:F of FIG. 15e.

16a-16k show various views of an example of a needle shield 78 of an auto-injector 10. The needle shield 78 has a needle receptacle 212 at its end with a syringe-facing surface 110. The syringe-facing surface 110 is disposed opposite a front end 214 of the needle shield 78. The needle shield 78 has outer dimensions configured to be received in the needle shield holder 104 and inner dimensions adapted to receive the needle 34 of a pre-filled syringe 16.

16a, 16b, 16d, and 16e show various perspective views from above and below the needle shield 78, 16c, 16f, 16g, and 16h show side views of the needle shield 78, respectively, 16i shows a cross section taken along section line B:B in 16g, 16j shows a view from the front end 214, and 16k shows a cross section taken along section line C:C in 16g.

Section B:B in FIG. 16i shows that the needle receptacle 212 is shaped complementarily to the needle 34 of the prefilled syringe 16. The function of the needle shield 78 is to protect the needle 34 from external influences.

17a-17l show various views of an example of a drive chassis 24 of an auto-injector 10. The drive chassis 24 has two trigger arms 36, each having respective components as discussed above, and a single audible feedback member 58 disposed on one side of the drive chassis 24.

Figures 17a and 17b show perspective views of the drive chassis 24, and Figures 17c-17f show different side views of the drive chassis 24. Figure 17g shows a cross section taken along section line E:E in Figure 17e through the dosing rim 22 with the plunger support 44.

Figure 17h shows a cross section taken along section line F:F of Figure 17e, showing the passage 140 formed therein through the trigger rim 32.

Figure 17i shows a cross section taken along section line G:G of Figure 17f, showing the parallel arrangement of the dosing rim 22 and the trigger rim 32.

Figure 17j shows a top view of the drive chassis 24 with the projection 154 of the trigger arm 36 projecting radially outward from the drive chassis 24.

Figure 17k shows a cross section taken along section line D:D of Figure 17e, and Figure 17l shows a cross section taken along section line C:C of Figure 17e at the level of the drive chassis 24 where the two protrusions 154 are positioned relative to the trigger arm 36.

17d and 17f, by way of example, show that the trigger rim 32 includes a lip 216 at an end disposed opposite the web 42. The lip 216 is configured to engage a clip arm 184 formed on the needle guard 18.

The lip 216 has two tips 218, each tip 218 configured to engage a respective one of the clip arms 184 formed on the needle guard 18.

It should also be noted that the first and second guide aids extend proximally from the web 42, the second groove 48' extends directly from the web 42, and the first groove 46' begins to offset from the web 42.

The above describes the mechanical elements of a disposable auto-injector 10 that dispenses medication M from a pre-filled syringe (PFS) 16. The disclosed design allows state-of-the-art mechanisms to be integrated into a small physical package using very few low-cost components and very simple processes compared to the state-of-the-art.

The disclosed auto-injector device consists of an assembly that surrounds a pre-filled syringe (PFS) 16 that contains medication M. Typically, such devices are intended for single use and administration by the patient (i.e., self-administration) or by a caregiver. At the time of use, the user removes the protective cap 70 from the proximal end of the auto-injector 10, positions the auto-injector 10 at the injection site (typically the skin of the thigh or abdomen), and axially pushes the auto-injector 10 proximally to achieve needle insertion of the needle 34 into the skin and initiate administration.

Energy from the helical compression drive spring 74 is released to displace the plunger 26 within the PFS 16, delivering the medication M to the patient. An audible click informs the patient that dosing is beginning. In this regard, it should be noted that such an audible click may be generated when the trigger arm 36 cooperates with the stop mechanism 54 in triggering the release mechanism 40 when moving the auto-injector 10 from the retraction stage to the dosing stage. The progress of dosing can be monitored by the user as the position of the PFS plunger 26 and the mechanism plunger change within the large curved "syringe window" 14.

The user knows when the dose is complete by an audible click emitted by the auto-injector 10 and a color change displayed within the unique "status indicator window" 20. The auto-injector 10 can then be removed from the injection site to allow the spring-loaded needle guard 18 to extend to cover the needle 34 under the action of a separate helical compression spring 76 to a locked position. In this locked position, the needle guard 18 covers the needle 34 and protects the patient or additional persons from needlestick injury.

The mechanism described utilizes a parallel drive arrangement in which the axis of the drive spring 74 is offset from the axis of the PFS 16, rather than being within the bore of the PFS 16 as is common in the prior art. This arrangement has several advantages.
The length of the auto-injector 10 can be minimized, as determined in large part by the length of the PFS 16 and the amount of plunger 26 travel.
- Allows flexibility in drive spring 74 specifications since geometry is not constrained by the bore diameter of the PFS 16 (eg, increasing or decreasing applied force, or making other modifications to improve manufacturing efficiency).
- Allows improved access to components and mechanisms where tubular arrangements often require multiple concentric (or at least coaxial) components that move relative to one another, which can be difficult to optimally connect to one another. Improved access also allows for simpler interactions between components, making trigger, feedback, and lockout mechanisms that tend to avoid the need for additional parts or complex mechanisms.

The simplicity of the mechanism reduces the number of components, which in turn helps to minimize the number of wall thicknesses required and therefore the width and depth of the device.

Due to the disposable nature of the single-use auto-injector 10, it is considered advantageous to thus minimize the complexity, material usage, packaging size, and assembly complexity of the auto-injector 10, all of which tend to reduce costs and environmental impact by:
- Reducing the amount of raw materials used.
- Reduces the cost of manufacturing equipment and assembly processes.
- It reduces the volume required for shipping and storage, which can be expensive especially when low temperatures are required.

The disclosed invention achieves this simplicity and small size while incorporating state-of-the-art user features and adding innovative new user features.

18a-18e show various views of further examples of the needle guard 18 and the inner body 80 of the housing 12 in different stages of use of a further type of auto-injector 10. As with the above-described designs of the illustrated auto-injector, the needle guard 18 is axially movably mounted within the housing 12 for movement between a retraction stage, an administration stage, and a lockout stage in which the needle guard 18 assumes different axial positions relative to the inner body 80 of the housing 12.

Below, only the differences between the needle guard 18 and the inner body 80 are discussed. Portions of the needle guard 18 and inner body 80 illustrated above but not discussed below may be similarly provided on the corresponding components.

Figure 18a shows the needle guard 18 and inner body 80 of the auto-injector 10 prior to use. One or more clip arms 184 of the needle guard 18 may each include a block 184' at an end thereof, which is configured to engage a lockout surface 234 of a notch 174 in the housing 12 of the auto-injector 10 during the lockout phase.

The notches 174 are each in the form of an aperture 174' having a contour that is at least approximately L-shaped, and the lockout surface is located on the short rim 236 of the L-shaped notch 174.

The lockout surface 234 is disposed on the short rim 236 at an angle to the long rim 238 of the L-shaped notch 174. The short rim 236 and the long rim 238 of the L-shaped notch 174 are disposed at an angle to each other, the angle being selected in the range of 10 to 120°, in particular 20 to 80°. In this example, the angle between the short rim 236 and the long rim 238 is 65°.

When assembled, the block 184' on the flexible arm (clip arm 184) of the needle guard 18 sits within the contoured aperture 174' of the inner body 80. The radial projection of the block 184' from the overall shape of the flexible arm 184 ensures that the block 184' overlaps the overall radial wall thickness of the inner body 80.

The block 184' of the clip arm 184 is positioned with transverse play relative to the corresponding inner body lockout surface 234, thus ensuring that the lockout surface 234 and the block 184' cannot engage prior to triggering.

The clip arm 184 of the needle guard 18 may be shaped to position the block nominally below the aperture 174' such that some deformation of the flexible arm 184 is required to achieve this assembled stage, and thus there is a transverse biasing force that holds the block 184' in the position shown.

Figure 18b shows the needle guard 18 and inner body 80 of the auto-injector 10 after the auto-injector 10 has been triggered. During use of the auto-injector 10, the needle guard 18 contacts the user's skin and the inner body 80 of the auto-injector 10 moves toward the user's skin, displacing the needle guard 18 distally toward the inner body 18 of the auto-injector 10. When a dosing event is initiated, the block 184' moves distally with the overall movement of the needle guard 18 until the block 18 engages the narrow region of the long rim of the contoured aperture.

This limits lateral movement of block 184' while a dosing event is occurring.

The block 184' travels along the long rim 238 of the contoured aperture 174 until it reaches the full travel of the needle guard 18, which may be limited by abutment in another area of the mechanism.

Axial movement of block 184' within aperture 174 may not be limited. Alternatively, it may be preferable to incorporate a detent mechanism (not shown) within the contoured aperture to provide a specific force feedback profile to the user during axial translation of needle guard 18.

Figure 18c shows the needle guard 18 and inner body 80 of the auto-injector 10 after administration of medication M has been completed. When an administration event occurs, the drive chassis 24 translates proximally to administer medication M from the PFS 16. As the drive chassis 24 translates proximally, the flexible mechanism of the drive chassis 24, the trigger arm 36, is deflected radially inward, traveling along the inner walls of the outer body 82 and inner body 80.

As the drive chassis 24 translates proximally along the axial direction A, transverse contact T occurs between the trigger arm 36 and the needle guard 18. Initially, this contact may occur with the needle guard 18, which can be considered rigid relative to the stiffness of the flexible trigger arm 36 (i.e., it is the trigger arm 36 that deflects, not the needle guard 18).

As the translation of the spring chassis 24 continues, the trigger arm 36 contacts the flexible arm 184 of the needle guard 18. The flexible arm 184 of the needle guard becomes effectively rigid as the block 18' is guided within the long rim 238 of the contoured aperture 174, preventing the block 184' from deflecting. Thus, the trigger arm 36 continues to be displaced or is further displaced in the transverse direction T.

When the drive chassis 24 has completed its transition, the trigger arm 36 may continue to disengage laterally by contact with the needle guard 18. An angled surface is provided on the needle guard so that contact with the trigger arm 36 provides a gradual retraction as the flexible arm 184 transitions from the block 184' at the end of the flexible arm 184 to the needle guard 18.

The geometry of the needle guard 18 is controlled to provide a smooth, gradual contact surface with the flexible trigger arm 36 so as not to cause loss of force that could affect the function of the auto-injector 10. The flexible arm 184 of the needle guard 18, constructed into the needle guard 18 at the distal end disposed opposite the proximal end 92 and extending proximally, is advantageous in this regard.

18d shows the needle guard 18 and inner body 80 of the auto-injector 10 when the needle guard 18 is locked out. After a dosing event, the auto-injector 10 is removed from the user's skin and the lockout spring 76 of the needle guard 18 exerts a force that extends the needle guard 18 proximally. The block 184' travels proximally along the long rim 238 defined by the contoured aperture 174' in the inner body 80. As the block 184' travels along this path, further transverse deflection of the trigger arm 36 may occur as the block 184' slides along the surface of the trigger arm 36. The block 184' is lifted upward in a contoured transverse movement by the long rim 238 of the aperture 174'.

As the needle guard 18 nears the end of its transition toward its proximal position, the block 184' on the flexible arm 184 of the needle guard 18 passes the lockout abutment surface 234 of the inner body and is axially aligned within the short rim 236 of the contoured aperture 174'. At this point, the biasing force provided by the contact and transverse deflection of the trigger arm 36 is sufficient to bias the flexible arm 184 and block 184' of the needle guard 18 into the raised position.

The geometry and materials of the flexible arm 184 on the needle guard 18 and the drive chassis 24 are specified so that the trigger arm 36 is more rigid, and therefore most of the remaining deflection occurs within the flexible arm 184 of the needle guard 18.

When this stage is reached, the raised position of the block 184' creates a transverse overlap between the surface 240 of the block 184' and the lockout abutment surface 234. The axial position of the needle guard 18 is restricted such that movement between the surface 240 of the block 184' and the lockout abutment surface 234 is minimized.

When the needle guard 18 is urged distally toward the housing 12 of the auto-injector 10, the surface 240 contacts the lockout abutment surface 234, preventing further distal movement of the needle guard 18. The surfaces 240, 234 are angled to encourage further engagement of the surfaces 240, 234 through further deflection of the flexible arm 184. At this stage, the needle 34 protection requirements can be met.

The proximal end of the trigger arm 36 may be elevated to transversely align with the contoured aperture 174' of the inner body 80. When this condition is reached, the end of the trigger arm 36 may move radially outward, such that the trigger arm 36 becomes transversely restrained by the contoured aperture 174'. Since the trigger arm 36 is locked at this elevated stage, this stage creates additional rigidity to create maximum deflection of the flexible arm 184 in the needle guard 18 and maximizes the overlap between the surface 240 on the block 184' and the lockout abutment surface 234 on the inner body 80.

Additional protection against large forces from a post-use impact event (the autoinjector 10 being dropped) is provided by this mechanism. During a drop test, the device must be decelerated from its impact velocity. Thus, the kinetic energy of the autoinjector 10, primarily in the form of internal energy (stress and strain), must be absorbed by the structure of the autoinjector 10. If the distance over which the autoinjector 10 is decelerated can be increased, the force required to decelerate the autoinjector 10 can be reduced. Therefore, it is advantageous to increase the distance between the impact surface and the surface limiting the movement so that the structural deflection is increased for a given applied load.

Thus, when the needle guard 18 is moved proximally between the administration stage and the lockout stage, each one of the one or more trigger arms 36 is configured to engage each one of the one or more clip arms 184.

Figure 18e shows the needle guard 18 and inner body 80 of the auto-injector 10. The load path between the impact surface and the lockout abutment is shown as the length of the long rim 238 of the aperture 174'.

Figure 18f shows the area under the curve representing the absorbed energy (both areas, and therefore the energy absorption, are the same, but the peak forces are significantly different). Thus, higher peak forces can be absorbed in a shorter transition distance.

Thus, a means is shown for limiting the axial movement of the needle protector sleeve 230 (see FIG. 20) in the auto-injector 10, which returns to a proximal position after an administration event and, once this final position is reached, further distal movement is limited. The movement of the needle guard 18 is limited by the axial abutment that occurs between the needle guard 18 and the housing 12 of the auto-injector 10. The axial movement of the components that move during administration is utilized to deflect a mechanism on the needle guard 18 to create a different abutment after an administration event has occurred.

19a-19j show various views of the inner body 80 of FIG. 18. FIGS. 19a and 19b show a side perspective view of the inner body 80, FIG. 19c shows a top view of the inner body 80, FIGS. 19d and 19f show side views of the inner body 80, FIGS. 19e and 19f show end views of the inner body 80, and FIGS. 19i-19h) show cross-sectional views of the cross-section shown in FIGS. 19f and 19g.

The inner body 80 has two contoured apertures 174' as notches 174 integrated into each side of the inner body 80. Although there may be a single aperture 174', due to the overall symmetry of the device, it may be beneficial to have similar contoured apertures 174' on both sides of the inner body 80.

The proximal end of the aperture 174' may have two abutment surfaces 242, 244. There may be an assembly abutment surface 242 against which the needle guard 18 proximally abuts before use. There may also be an extended abutment surface 244 against which the needle guard 18 proximally abuts after use.

There may be an axial offset between the assembly abutment surface 242 and the extended abutment surface 244. Alternatively, there may be no axial offset between the surfaces 242, 244. The surfaces 242, 244 may be offset transversely, and the transverse width of the aperture 174' at the proximal end may allow unrestricted movement of the abutment surfaces 242, 244 toward the distal end.

The contoured aperture 174' may be narrower in the transverse direction toward the proximal end, i.e., along the long rim 238, than the transverse width of the aperture 174'. In particular, the width of the aperture 174' toward the distal end may match the transverse height of the block 184' such that the block 184' follows a defined path as the needle guard 18 transitions distally.

A lockout abutment surface 234 is located at the distal end of a short rim 236 of the aperture 174'. This lockout abutment surface 234 limits the distal movement of the needle guard 18. The described shaped geometry ensures that the distal movement of the needle guard 18 is not limited by this mechanism prior to use, but is limited by this mechanism after an administration event has occurred.

20a-20j show various views of the needle guard 18 of FIG. 18. Along the flexible arm 184 is incorporated a block 184' that projects radially outward from the arm 184. This block 184' may be located at the free end of the flexible arm 184 and may limit translation in the proximal direction prior to use.

This block 184' may also limit migration in the proximal direction after use. These proximal migration limiting features are referred to as assembly surfaces 242. After use, the proximal migration limit is limited by extended abutment surfaces 244, which limit proximal migration before use. This block 184' may also limit migration in the distal direction after use, providing a lockout abutment. The features providing the lockout abutment are referred to as "lockout surfaces" 234.

One or more clip arms 184 extend proximally from the needle guard 18 parallel to the axial direction A. One or more clip arms 184 extend proximally from the plunger arm 142 of the needle guard 18.

The needle guard 18 includes a sleeve 230 at its proximal end 92. The needle guard 18 is at least approximately T-shaped in design, with the plunger arm 142 oriented parallel to the axis A of the auto-injector 10 from the proximal end 92 to the distal end of said sleeve 230.

The sleeve 230 includes one or more elongated slots 232 that extend parallel to the axis A of the auto-injector 10 from the proximal end to the distal end of the sleeve 230.

This further type of needle guard 18 and inner body 80 describes a mechanism for controlling the transition limits of the needle guard 18 of a disposable auto-injector 10 used to administer medication from a pre-filled syringe 16. The disclosed mechanism allows the full distal transition of the needle guard 18 to occur during the first use of the auto-injector when an administration event is initiated. After the administration event occurs and the auto-injector 10 is removed from the injection site, the mechanism allows the needle guard 18 to transition to a final proximal position. Once in the final position, the needle guard 18 is locked out to prevent further distal transition. This lock is intended to withstand sufficient axial force to provide the necessary protection from the needle 34, even in the event of an impact from dropping the auto-injector 10.

The drive chassis 24 described in connection with the auto-injector 10 of the type described above can be used with the inner body 80 and needle guard 18 to utilize the displacement of the drive chassis that occurs during a dosing event to provide lockout when the final position is reached. The force required to axially displace the needle guard 18 to the final position is designed to be low, allowing the force output of the lockout spring 76 to be minimized. This helps achieve the desired low trigger force since the user must compress this spring 76 to operate the auto-injector 10.

When in the final post-administration position, the needle guard 18 must react with enough force over a sufficient transition to absorb the kinetic energy of the auto-injector 10 in an impact event to achieve lockout. The mechanism provides an extended load path along the entire length of the needle guard 18 and back along its compliant mechanism, providing additional radial support for the compliant mechanism to achieve both high reaction loads and high displacement while under load. Both of these combine to provide a large energy absorption capacity to better enable the auto-injector 10 to withstand an impact event.

The mechanism does not require any additional parts to be added to the auto-injector 10 described in Figures 1-20. The mechanism described can be retrofitted to existing components while maintaining existing injection molding tooling strategies and existing assembly sequences.

21 shows an exploded view of the components of a further type of auto-injector 10. The auto-injector 10 includes a drive chassis 24, a drive spring 74, an inner body 80, an outer body 82, a cap 70, a needle guard 18, a needle guard spring 76, and a pre-filled syringe 16.

Figure 22 shows a perspective view of the needle guard 18 of the auto-injector 10 of Figure 21. The needle guard is of a similar design to that shown in connection with Figure 20.

The needle guard 18 includes two clip arms 184 each having a respective block 184' at the end of each of the two clip arms 184 that acts as a lockout block mechanism. The end surfaces of each clip arm 184 and block 184' are known as assembly stop mechanisms 246.

When the lockout stage is reached, the assembly stop mechanism 246 abuts against the assembly abutment surface 242 of the inner body 80, as shown, for example, in connection with FIG. 31.

The clip arm 184 on the needle guard 18 is biased against the inner end surface of the aperture 174' in the inner body 80 to provide a stop that limits the movement of the needle guard 18 relative to the housing 12.

Figure 23 shows a perspective view of the drive chassis 24 of the auto-injector of Figure 21. The main difference is that an end-of-dose ramp 248 is provided on the trigger rim 32. The end-of-dose ramp 248 is configured to cooperate with an end-of-dose click arm 250 present on the inner surface of the inner body 80, as seen in Figure 24b.

As the end of dose (EoD) approaches, the EoD click arm 250 on the inner body 80 engages with the EoD ramp 248 on the drive chassis 234, deflecting the EoD arm 250 laterally toward the center of the device.

The EoD click arm 250 penetrates the proximal end of the drive chassis 24 and drops off the end of the EoD ramp 248, releasing its stored energy and creating an audible click.

In this regard, it should be noted that the click always occurs before the device reaches the "Fully Dispensed-Rigid Stopper" state, i.e., before the plunger 26 reaches a position within the prefilled syringe 16 where it can no longer move.

The EoD ramp 248 is located at or approximately the same axial position as the proximal end of the first portion outer surface 50 of the trigger arm 36 and of the trigger rim 32.

It should further be noted that the web 42 also improves the damping function within the auto-injector 10. This is because when the drive chassis 24 impacts the plunger 26 during triggering of a dose, a large amount of energy is transferred to the syringe 16. If the load path were rigid, this would result in a very large force being applied to the flange of the syringe 16 that could break the flange. The web 42 connecting the dose rim 22 to the trigger rim 32 provides flexibility between these two limbs 22, 32, which essentially reduces the force applied to the syringe flange during triggering of a dose.

24a shows a perspective view of the inner body 80 of the auto-injector 10 of FIG. 21, and FIG. 24b shows a partial cross-sectional perspective view of the interior of the inner body 80 showing the location of the EoD click arm 250. This is located approximately 30% of the length of the inner body 80 from the proximal end 92.

In this regard, it should be noted that the EoD click arm 250 can be positioned within the inner body 80 at an axial height of the inner body 80 within a range of 10% to 50%, preferably 20% to 40%, of the length of the inner body 80 from the proximal end 92.

The use of click arm 250 in cooperation with ramp 248 to provide the end-of-dose click in the manner described above results in a louder click compared to designs using a nose, such as that shown in FIG. 11. This has the advantages of reducing free play between the components, increasing the amount of deflection possible, and moving the clicking mechanism away from the exterior surface (where it is less likely to be dampened by the user's hand).

25a-25c show views of the outer body 82 of the auto-injector 10 of FIG. 21 configured to cooperate with the components of the auto-injector 10 shown in FIG. 21.

In contrast to the outer body 82 shown in, for example, FIG. 1, the proximal positions of the syringe window 14 and the status indicator window 20 are the same, or at least approximately the same, as in the outer body 82 of FIG. 25a.

By moving the status indicator window 20 downward, i.e., toward the proximal end, the number of components that must be changed to accommodate different PFS 16 loadings can be reduced, thereby making the auto-injector 10 more versatile.

This also has the effect that in the pre-dose state, i.e., before the auto-injector 10 is actuated and the later-visible portions of the status indicator window 20 are not visible, the drive chassis 10 will not be visible behind the window.

In this regard, the status indicator window 20 can be textured so that the internal mechanisms are obscured when the drive chassis 24 is at the distal end of the outer body 82 and therefore not visible through the status indicator window 20.

When dosing is complete, the drive chassis 24 should appear behind the status indicator window 20, filling the window with color. Showing the drive chassis 24 in only one stage (the "dosing complete" stage) has the advantage that there is no need to print on the outer surface 49 of the drive chassis 24 since it only appears once.

FIG. 5b shows a protrusion 86 on the distal wall 84 of the outer body 82. The protrusion 86 has a pointed end formed by three surfaces that come together to form a pointed end. The protrusion 86 is formed such that it is journaled by the drive spring 74 when the auto-injector 10 is in use.

In this regard, it should be noted that the protrusion 86 shown in FIG. 26b has a length greater than the length of the protrusion shown in FIG. 5b.

It should further be noted that the length of the protrusion may be selected in the range of 5% to 50% of the length of the outer body 82, preferably in the range of 10% to 40% of the length of the outer body 82.

Also visible in FIG. 25c is the convex surface 152 of the stop mechanism 54. The convex surface 152 is formed by two flat surfaces 156, 158 that meet at an apex 160.

Figure 26 shows a perspective view of the cap 70 of the auto-injector of Figure 21. The cap is constructed similarly to the cap 70 shown, for example, in Figure 5a. The difference is in the position of the recess 114 located between the two windows 112. In Figure 5a, the recess 114 is arranged parallel to the transverse direction T, whereas in Figure 26, it is arranged perpendicular to the transverse direction T.

It should further be noted that the inner surface 118 of the outer wall 116 of the cap 70 includes two ribs 120 on each longitudinal side, and the cap 70 shown in FIG. 5a includes three such ribs 130 on each side.

Figures 27a-d show various views of a further type of cap 70. A clip 252 is provided in the type of cap 70 shown in Figures 27a and 27b that engages the distal end of the removable needle shield 78, while in the cap 70 shown in Figures 27c and 27d, the clip is configured to engage the side wall of the removable needle shield 78.

In each case, the needle shield holder 104 has two windows 112 that are reduced in size compared to the cap 70 shown, for example, in connection with FIG. 4a, which does not have a recess 114 between the windows 112.

The window 112 and the needle shield holder are each configured to hold the clip 252 in place, such that the clip 252 is configured to remove the removable needle shield 78 upon removal of the cap 70 from the auto-injector 10. To this end, the clip 252 includes a barb 254 that engages with the respective window 112.

As also shown, the free end of the clip 252 facing the removable needle shield 78 is configured to exert pressure on the removable needle shield 78 such that upon removal of the cap 70, the removable needle shield 78 is also automatically removed.

28a-c show various views of the auto-injector 10 of FIG. 21 in a partially schematic cross-sectional view in the retracted stage. FIG. 28a shows how the cap 70 is placed on the proximal end 28 of the needle guard 18. This engagement is achieved via a snap-fit connection 94 that exists between a snap-fit area 98 of the cap and a snap-fit protrusion 96 of the needle guard 18.

As shown in FIG. 28b, in the stored position, the drive spring 74 is compressed and applies an axial load between the outer body 82 and the drive chassis 24.

The drive chassis 24 is prevented from moving by the engagement of two trigger arms 36 which engage with stop mechanisms 54 on the outer body 82.

Each trigger arm 36 and stop mechanism includes an angled surface that is angled such that, under the action of an axial force from the drive spring 74 against the drive chassis 24, the trigger arm 36 is biased into engagement and prevented from moving transversely or radially inwardly relative to the stop mechanism 54.

The drive spring 74 is supported within the drive chassis 24 in a spring bore, also known as a passage 140, and on a protrusion 86 of the outer body 82, also known as a spring support pin.

The inner body 80 and outer body 82 are clipped together at a status indicator window clip joint formed by a protrusion 256 formed on the inner body that fits within the status indicator window 20 of the outer body 82.

The protrusion 108 of the needle shield holder 104 present on the cap 70 engages behind the distal end of the rigid needle shield 78. The distal end of the cap 70 is pressed against the inner body 80.

The lockout spring 76 applies an axial force between the inner body 80 and the needle guard 18. The syringe is supported radially by syringe ribs 258 on the inner body 80 and axially near the distal end of the inner body 80 by a syringe flange ring 260 (see also FIG. 24b). The syringe flange ring 260 provides some radial interference to minimize wobble and free axial movement of the syringe 16.

The syringe 16 is prevented from moving distally by the ribs on the outer body 82 (and also by the engagement of the RNS 78 with the cap 70).

When a cut flange syringe is fitted, it may be prevented from rotating by providing an additional rib (not shown) on the inner body 80.

In this regard, it should be noted that the inner body 80 may include a support element (not shown) that supports the trigger arm 36 of the drive chassis 24 during the retraction phase of the automatic injector 10.

Such a support element would be located at the distal end of the inner body 80 to engage the trigger arm 36 at 30% to 70% of its length, increasing the stiffness of the trigger arm 36 and acting as a support to prevent the trigger arm 36 from unnecessarily disengaging from the stop mechanism 54.

At the time of use, the user removes the cap 70 and overcomes the snap-fit connection 94, i.e., protrusion 96, to remove the RNS 78 from the syringe 16 via the cap 70 having protrusion 108 (or an equivalent metal pressing as shown in Figures 27a-d). As shown in Figure 28b, the removable needle shield 78 is captured within the cap 70 after removal.

29a and 29b show views of the auto-injector of FIG. 21 upon triggering, i.e., actuation, of the auto-injector 10. To this end, the user holds the outer body 82 and presses the needle guard 18 against the skin, which causes the needle guard 18 to move distally within the outer body 82 against the force of the lockout spring 76 (which is compressed).

During this movement, the plunger arm 142 at the distal end of the needle guard 18 contacts the trigger arm 36 of the drive chassis 24 via the engagement surface 146, pushing them laterally.

As the trigger arm 36 moves laterally, it moves up the slope of the first flat surface 156, causing the drive chassis 24 to move slightly distally, which in turn causes the drive spring 74 to compress slightly further.

When the needle guard 18 pushes the trigger arm 36 laterally past the apex 160 of the convex surface 152 that acts as the trigger stop of the stop mechanism 54 of the outer body 82, the force from the drive spring 74 against the spring chassis 24 causes the trigger arm 36 to slide down the second flat surface 258, i.e., the steeper slope of the trigger stop.

When the trigger arm 36 is released from the trigger stop, i.e., from the stop mechanism, by the large force exerted by the drive spring 74, an "audible click" is emitted (due to the sudden release of energy).

Figures 29a and 29b show the auto-injector 10 at a stage where the needle guard 18 has moved distally but has not yet engaged the stop mechanism.

Figures 30a-i show the movement of the needle guard 18, trigger arm 36, and drive chassis 24 after actuation of the auto-injector 10. Figures 30a-d show the movement of the stop mechanism 54 relative to the trigger arm 36 after the needle guard 18 engages the trigger arm 36.

Figure 30a shows the release mechanism in the unactuated stage, i.e., with the convex surface 262 of the trigger arm 36 resting on the convex surface 152 of the stop mechanism 54.

In this regard, it should be noted that the concave surface 262 is complementary to the convex surface to minimize play between the two components.

For this purpose, the concave surface 262 has a first flat portion 264 and a second flat portion 266 that are connected to each other via a recess 268.

Figure 30b illustrates slight distal movement of the trigger arm 36 relative to the stop mechanism 54 as the needle guard 18 further compresses the biased drive spring 74 and the trigger arm 36 moves in the transverse direction T.

The needle guard 18 continues to be displaced distally until it stops at the rib feature 270 of the inner body 80, as shown in Figures 30e and 30f. At this point, the needle guard 18 is fully engaged with the trigger arm 36 of the drive chassis 24, causing them to move laterally as far as necessary to transition past the apex 160 of the stop feature 54 of the outer body 82, as shown in Figure 30d.

As the drive chassis 24 advances proximally as shown in FIG. 30f, the trigger arm 36 slides along the clip arm 184 of the needle guard 18. This tends to bias the clip arm 184 transversely (upward, FIG. 30g) against the surface of the long rim 238 of the aperture 174' in the inner body 80.

When the trigger arm 36 is released from the stop mechanism 54 of the release mechanism 40, the drive chassis 24 moves in the proximal direction under the action of the drive spring 74.

The dosing rim 22 of the drive chassis 24 contacts the plunger 26 (which may have an initial gap) and then begins to move the plunger 26, forcing the medication through the needle 34. When the plunger 26 reaches the "full dose stage", the first portion outer surface 50 of the drive chassis 24 begins to fill the status indicator window 20, and the molded (optionally light) color of the drive chassis 24 becomes visible through the window 20, providing the user with a clear binary indication that dosing is complete. Before dosing, the drive chassis 24 is directly behind the window 20 and is not visible, so it appears dark due to any shadows inside the device.

The drive spring 74 continues to advance the drive chassis 24 until one of the following occurs (depending on the flexibility of the stops and component tolerances):

The protrusions 86 on the outer body 82 remain axially aligned with the drive chassis 24 so that the drive spring 74 is fully supported (and prevented from buckling) throughout the entire administration.

In an ideal situation, the trigger arm 36 requires little force to deform laterally, i.e., is laterally flexible (to reduce the force required by the user to trigger the auto-injector 10), but is very stiff and strong axially (to avoid buckling under long-term loads from the drive spring 74). To attempt to achieve this, the trigger arm 36 of the drive chassis may be made thicker in a central section (to increase buckling strength) and thinner at the base (to reduce lateral stiffness).

30h and 30i, the EoD click arm 248 of the inner body 80 engages the EoD ramp 248 of the drive chassis 24, providing an audible click. As can also be seen in FIG. 30h, the web 42 of the drive chassis abuts the drive chassis support 242, which is configured to absorb any residual force remaining in the system upon unspringing the drive spring 74.

FIG. 31 shows a view of the auto-injector 10 of FIG. 21 in the lockout stage. As the auto-injector 10 is removed from the skin, the needle guard 18 extends proximally from the inner body 80 under the action of the lockout spring 76.

The block 184' at the end of the clip arm 184 is biased transversely (upward in the top view) within the short rim 236 of the aperture 174' in the inner body 80 by the trigger arm 36 of the drive chassis 24.

As the needle guard 18 moves proximally, the block 184' moves proximally along the long rim 238, and upon reaching the short rim 236, the block 184' is configured to be deflected by the trigger arm 36 and locked within the short rim 236.

The lockout spring 76 biases the block 184' proximally against the lockout surface 234 of the aperture 174' to prevent further proximal movement of the needle guard 18.

If the user removes the auto-injector from the skin before the dose is complete, the needle guard 18 is extended by the lockout spring 76. The drive spring 74 still continues to advance the drive chassis 24 within the syringe 16, and liquid is still dispensed from the needle 34. For the remainder of the dose, the trigger arm moves the clip arm 184 of the needle guard 18 to a locked position within the aperture 174', as in a "normal" dose.

List of embodiments 1. A housing 12;
a pre-filled syringe 16 mounted within and fixed relative to the housing 12;
a needle guard 18 axially movably mounted within the housing 12 for movement between a retracted stage, an administering stage, and a lockout stage, the retracted stage, the administering stage, and the lockout stage having different axial positions relative to the housing 12;
a needle guard 18 configured for axial movement in a distal direction between a retraction stage and an administration stage;
the needle guard 18 is configured to move axially in the proximal direction between the administration stage and the lockout stage;
Auto-injector 10.

2. The auto-injector 10 of embodiment 1, in which the needle guard 18 surrounds the needle 34 of the pre-filled syringe 16 during the retraction and lockout phases.

3. The auto-injector 10 of embodiment 1 or embodiment 2, wherein the needle guard 18 does not surround the needle 34 of the prefilled syringe 16 during the administration phase.

4. The automatic injector 10 of any one of embodiments 1 to 3, further comprising a lockout spring 76 disposed between the needle guard 18 and the housing 12.

5. The automatic injector 10 of embodiment 4, wherein the needle guard 18 is configured to compress the lockout spring 76 when moving between the retraction stage and the administration stage.

6. The automatic injector 10 of embodiment 4 or embodiment 5, wherein the needle guard 18 is configured to move between the administration phase and the lockout phase upon relaxation of the lockout spring 76.

7. The automatic injector 10 of any one of embodiments 1 to 6, wherein the needle guard 18 includes one or more lockout arms 186.

8. The automatic injector 10 of embodiment 7, wherein one or more lockout arms 186 include an engagement portion 220 configured to engage a corresponding notch 176 in the housing 12 of the automatic injector 10 during the lockout phase.

9. The automatic injector 10 according to any one of embodiments 4 to 8 and embodiment 7, wherein two or more lockout arms 186 are provided and the lockout spring 76 is disposed between the two or more lockout arms 186.

10. The automatic injector 10 according to any one of embodiments 1 to 9, wherein the needle guard 18 includes a retention mechanism 170 that cooperates with the housing 12.

11. The automatic injector 10 of any one of embodiments 1 to 10, wherein the needle guard 18 includes a plunger arm 142 that activates the release mechanism 40 of the automatic injector 10.

12. The automatic injector 10 of embodiments 10 and 11, in which the anti-slip mechanism 170 is disposed on the plunger arm 142.

13. The automatic injector 10 according to any one of embodiments 10 to 12, wherein the retention mechanism 170 comprises a protrusion 166 that engages with a hole 168 present in the housing 12.

14. The auto-injector 10 of any one of embodiments 1 to 13, further comprising a drive chassis 24, the drive chassis 24 being mounted to the housing 12, the drive chassis 24 being biased relative to the housing 12, and the drive chassis 24 being further fixed relative to the housing 12 and against movement relative to the housing 12 during a retraction phase of the auto-injector 10.

15. The automatic injector 10 of embodiment 14 and embodiments 7 to 13, wherein the drive chassis 24 is configured to engage one or more clip arms 184 and deflect them radially inwardly away from the housing 12 during the administration phase.

16. The auto-injector 10 of any one of embodiments 14 or 15 and embodiments 11 to 13, wherein the plunger arm 142 is configured to cooperate with the trigger arm 36 of the drive chassis 24 to activate the release mechanism 40 of the auto-injector 10.

17. The auto-injector 10 of any one of embodiments 14 to 16, wherein axial movement of the needle guard 18 toward the drive chassis 24 unlocks the drive chassis 24 from the housing 12 upon actuation of the auto-injector 10.

18. The automatic injector 10 of embodiment 16 or embodiment 17, wherein axial movement of the needle guard 18 is configured to deflect the trigger arm 36 in a direction transverse to the axial movement.

19. The automatic injector 10 of any one of embodiments 16-18 and any one of embodiments 11-15, wherein the plunger arm 142 is configured to deflect the trigger arm 36 in a direction transverse to the axial movement of the needle guard 18.

20. The automatic injector 10 of any one of embodiments 1 to 19, wherein the needle guard 18 includes a blocking rib 144.

21. The automatic injector 10 of embodiment 20 and any one of embodiments 16 to 19, wherein the blocking rib 144 is configured to block radial movement of the trigger arm 36.

22. The automatic injector 10 of any one of embodiments 1 to 21, wherein the needle guard 18 further comprises a cam 162 having an engagement surface 146.

23. The automatic injector 10 of any one of embodiments 16 to 21 and embodiment 22, wherein the engagement surface 146 is configured to engage the trigger arm 36.

24. The automatic injector 10 of embodiment 23, wherein the trigger arm 36 includes a web 148 and the engagement surface 146 engages the web 148 of the trigger arm 36.

25. The automatic injector 10 of any one of embodiments 21 to 24 and embodiment 20, wherein the engagement surface 146 protrudes from the block rib 144.

26. The automatic injector 10 of embodiment 24 or embodiment 25, wherein the web 148 includes a deflection surface 150 that is inclined relative to the direction of movement of the drive chassis 24.

27. The automatic injector 10 according to any one of embodiments 20 to 26, wherein the engagement surface 146 is inclined relative to the direction of movement of the drive chassis 24.

28. The automatic injector 10 of embodiments 26 and 27, in which the engagement surface 146 and the deflection surface 150 are cooperatively inclined relative to the direction of movement of the drive chassis 24.

29. The automatic injector 10 of embodiment 28, wherein the engagement surface 146 is inclined to bias the trigger arm 36 in a direction transverse to the axis of movement of the needle guard 18.

30. The automatic injector 10 according to any one of embodiments 14 to 29, further comprising a drive spring 74 configured to drive the drive chassis 24 towards the needle guard 18 after actuation of the automatic injector 10.

31. The automatic injector 10 of any one of embodiments 1 to 30, wherein the needle guard 18 is configured to cooperate with the cap 70 via one or more snap-fit connections 94.

32. The automatic injector 10 of embodiment 31, wherein each snap-fit connection includes a snap-fit protrusion 96 that cooperates with a corresponding snap-fit area 98.

33. The automatic injector 10 of embodiment 32, wherein the needle guard 18 includes one or more snap-fit protrusions 96.

34. The automatic injector 10 of embodiment 32 or embodiment 33, wherein one or more snap-fit protrusions 96 are provided on the outer surface 126 of the needle guard 18.

35. The automatic injector 10 of any one of embodiments 32 to 34, wherein the inner surface 128, 132 of the housing 12 includes one or more grooves 130, 134 in which one or more of the snap-fit protrusions 96 can move axially relative to the housing 12 upon axial movement of the needle guard 18.

36. The automatic injector 10 according to any one of embodiments 31 to 35, wherein the front end 122 of the needle guard 18 is disposed within the opening 124 of the cap 70.

37. The automatic injector 10 according to any one of embodiments 31 to 36, wherein the outer wall 116 of the cap 70 contacts the outer wall 136 of the housing 12 during the storage phase of the automatic injector 10.

38. The automatic injector 10 of embodiment 37, in which the outer wall 116 of the cap 70 and the outer wall 136 of the housing 12 do not overlap in the axial direction of the automatic injector 10.

39. The automatic injector 10 of embodiment 37 or embodiment 38, wherein the outer wall 116 of the cap 70 and the outer wall 136 of the housing 12 overlap radially during the storage phase of the automatic injector 10.

40. The automatic injector 10 of any one of embodiments 1 to 39, wherein the housing 12 is a two-part housing 12 comprising an inner body 80 and an outer body 82.

41. The auto-injector 10 according to any one of the preceding embodiments, further comprising a drive chassis 24 mounted to the housing 12, the drive chassis 24 being biased relative to the housing 12, the drive chassis 24 being further fixed relative to the housing 12 and against movement relative to the housing 12 during a retraction phase of the auto-injector 10, and the drive chassis 24 moving relative to the housing 12 when administering a substance from the pre-filled syringe 16.

42. The automatic injector 10 of embodiment 41, wherein the automatic injector 10 is configured to generate an audible end-of-dosage feedback between the drive chassis 24 and the housing 12 when the substance is administered from the automatic injector 10.

43. The auto-injector 10 of any one of embodiments 1 to 42, further comprising a drive chassis 24 mounted to the housing 12, the drive chassis 24 being biased against the housing 12 by a drive spring 74, the drive chassis 24 being further fixed against the housing 12 and against movement relative to the housing 12 during a retraction phase of the auto-injector 10.

44. The automatic injector 10 of embodiment 43, wherein the drive chassis 24 includes a trigger arm 36 that engages a stop mechanism 54 present in the housing 12 during a retraction phase of the automatic injector 10 to secure the drive chassis 24 relative to the housing 12.

45. The automatic injector 10 of embodiment 44, wherein the trigger arm 36 is configured to disengage from the stop mechanism 54 upon actuation of the automatic injector 10.

46. The automatic injector 10 according to any one of the preceding embodiments, further comprising a needle shield 78 covering the needle 34 of the prefilled syringe 16 during the retraction phase of the automatic injector 10, an axially movable needle guard 18 arranged to cover the needle 34 of the prefilled syringe 16 at least after use of the automatic injector 10 and to move relative to the prefilled syringe 16 during use of the automatic injector 10, and a removable cap 70 into which the needle guard 18 is retracted during the retraction phase of the automatic injector 10.

47. The automatic injector 10 of embodiment 46, wherein the cap 70 is removably connected to the needle guard 18 during the storage phase of the automatic injector 10, and when the cap 70 is removed, the needle shield 78 is also removed from the automatic injector 10.

48. The automatic injector 10 according to any one of the preceding embodiments, further comprising a drive chassis 24 mounted to the housing 12, the drive chassis 24 being biased against the housing 12 and being fixed to the housing 12 during a retraction phase of the automatic injector 10.

49. The automatic injector 10 according to embodiment 48, further comprising a status indicator window 20 arranged in the housing 12 through which the drive chassis 24 is visible from the outside, the status indicator window 20 indicating a first portion 50 of the drive chassis 24 during a storage stage of the automatic injector 10 and a second portion 52 of the drive chassis 24 after use of the automatic injector 10, such that the first portion 50 and the second portion 52 of the drive chassis 24 are distinguishable from each other.

50. The automatic injector 10 according to any one of the preceding embodiments, further comprising a drive chassis 24, the drive chassis 24 comprising a dose rim 22 and a trigger rim 32, the plunger 26 being positionable at a proximal end of the dose rim 22, and the trigger arm 36 being positioned extending proximally from the trigger rim 32.

51. The automatic injector 10 according to embodiment 50, wherein the trigger rim 32 and the dose rim 22 are arranged parallel to each other, at least essentially parallel to each other, and are connected to each other at the distal end side of the dose rim 22 and the trigger rim 32, respectively, via the web 42.

52. The automatic injector 10, optionally according to any one of the preceding embodiments, further comprising:
A housing 12;
A pre-filled syringe 16 attached to the housing 12;
a drive chassis 24 mounted to the housing 12, the drive chassis 24 being biased relative to the housing 12 and fixed relative to the housing 12 and against movement relative to the housing 12 during a retraction phase of the automatic injector 10, and moving relative to the housing 12 when administering a substance from the pre-filled syringe 16;
the automatic injector (10) includes an audible feedback member (58) configured to generate an audible end-of-dose feedback between the drive chassis (24) and the housing (12) when the substance is dispensed from the automatic injector (10);
Auto-injector 10.

53. The auto-injector 10 of any one or more of the above embodiments, wherein the drive chassis 24 includes a first portion 56 of an audible feedback member 58 that engages a second portion 66 of the audible feedback member 58 disposed on the housing 12 to generate an audible end-of-dose feedback.

54. The auto-injector 10 of any one or more of the above embodiments, wherein the housing 12 includes a recess 208 and a drive chassis 24 that engages the recess 208 to generate an audible end-of-dose feedback.

55. The automatic injector 10 of embodiments 53 and 54, wherein the first portion 56 of the audible feedback member 58 of the drive chassis 24 engages the recess 208 to generate an audible end-of-dose feedback.

56. The auto-injector 10 of any one or more of the above embodiments, wherein the housing 12 includes a distal inner housing end 204 that is chamfered on its inner surface 132.

57. The automatic injector 10 of embodiment 56, wherein the chamfered distal inner housing end 204 biases the drive chassis 24 radially inward as the drive chassis 24 moves from the retracted stage to the end-of-dosing stage.

58. The automatic injector 10 of embodiment 57 and one of embodiments 53 to 56, wherein the chamfered distal inner housing end 204 biases the first portion 56 of the audible feedback member 58 radially inward as the drive chassis 24 moves from the retracted stage to the end-of-dose stage.

59. The chamfered distal inner housing end 204 is configured to bias the first portion 56 of the audible feedback member 58 radially inward before the first portion 56 of the audible feedback member 58 engages the recess 208;
The automatic injector 10 according to embodiment 58.

60. The auto-injector 10 of any one or more of the above embodiments, wherein the audible end-of-dose feedback comprises an audible click.

61. The automatic injector 10 of embodiment 60, wherein the audible click is caused by at least one of contact between the two components 56, 66 and acceleration of the component 56.

62. The automatic injector 10 of embodiment 60 or embodiment 61 and one of embodiments 57 to 59, wherein the audible click is generated by the radially inwardly biased portion 56 of the drive chassis 24 relaxing radially outward.

63. The auto-injector 10 according to one or more of the above embodiments, wherein the drive chassis 24 further comprises a plunger support 44 that engages the plunger 26 of the pre-filled syringe 16.

64. The automatic injector 10 of any one of embodiments 63 and 55-62, wherein the first portion 56 of the audible feedback member 58 extends from the drive chassis 24 at a portion of the drive chassis 24 different from the plunger support 44.

65. The auto-injector 10 of any one or more of the above embodiments, further comprising a drive spring 74 mounted between the drive chassis 24 and the housing 12.

66. The automatic injector 10 according to one of the embodiments 65 and 63 and 64, wherein after actuation of the automatic injector 10, relaxation of the drive spring 74 drives the plunger support 44 towards the plunger 26 of the prefilled syringe 16.

67. The automatic injector 10 of embodiment 66, wherein the drive spring 74 is disposed within a portion of the drive chassis 24 that includes the first portion 56 of the audible feedback member 58, specifically within the passageway 140.

68. The auto-injector 10 of any one or more of the above embodiments, wherein the housing 12 is a two-part housing comprising an inner body 80 and an outer body 82.

69. The automatic injector 10 of embodiment 68, wherein the inner body 80 and the outer body 82 are fixed in position relative to each other.

70. The automatic injector 10 of embodiment 68 or embodiment 69, wherein the inner body 80 and the outer body 82 are connected to each other via the connection 72.

71. The automatic injector 10 of embodiment 70, wherein the connection 72 is formed by a nose 188 that engages with a window 190.

72. The automatic injector 10 of embodiment 71, wherein the nose 188 is formed on the inner body 80 and engages a window 190 formed on the outer body 82.

73. The automatic injector 10 according to any one of embodiments 68 and 54 to 72, wherein the inner body 80 comprises a recess 208.

74. The auto-injector 10 of one or more of the above embodiments, wherein the inner body 80 includes one or more notches 174, 176, and/or holes 168 configured to cooperate with one or more corresponding portions 184, 186, 166 of the needle guard 18.

75. The automatic injector 10 of one or more of embodiments 68 to 74 and one or more of embodiments 54 to 66, wherein the drive spring 74 is disposed between the outer body 82 and the drive chassis 24.

76. The auto-injector 10 according to one or more of the above embodiments, wherein the drive chassis 24 is of a generally U-shaped design and includes a dosing rim 22 as well as a trigger rim 32.

77. The automatic injector 10 of any one or more of the above embodiments, wherein the drive chassis 24, the first portion 56 of the audible feedback member 58, and the plunger support 44 are formed in one piece from the same material.

78. The auto-injector 10, optionally according to one or more of the above embodiments,
a housing 12 in which a prefilled syringe 16 is disposed;
a drive chassis 24 mounted to said housing 12, said drive chassis 24 being biased against said housing 12 by a drive spring 74 and being fixed against movement relative to said housing 12 and relative to said housing 12 during a retraction phase of the automatic injector;
the drive chassis 24 includes a trigger arm 36 that engages a stop mechanism 54 present in the housing 12 during the retraction phase of the auto-injector 10 to secure the drive chassis 24 relative to the housing 12;
The automatic injector 10 is configured such that upon actuation of the automatic injector 10, the trigger arm 36 disengages from said stop mechanism 54.

79. The automatic injector 10 of any one or more of the above embodiments, wherein the stop mechanism 54 includes an opening 138.

80. The automatic injector 10 of any one or more of the above embodiments, wherein the stop mechanism 54 includes a convex surface 152.

81. The automatic injector 10 of embodiment 80, wherein the trigger arm 36 is configured to cooperate with the convex surface 152 of the stop mechanism 54.

82. The automatic injector 10 of any one or more of the above embodiments, wherein the trigger arm 36 includes a protrusion 154 that engages the stop mechanism 54.

83. The automatic injector 10 of embodiment 82, wherein the protrusion 154 is configured to cooperate with the opening 138.

84. The automatic injector 10 according to one of embodiments 82 or 83, wherein the protrusion 156 is configured to cooperate with the convex surface 152.

85. The automatic injector 10 of any one or more of the above embodiments, wherein the trigger arm 36 includes a web 148 extending therefrom.

86. The automatic injector 10 of embodiment 85 and embodiment 84 or embodiment 83, wherein the web 148 is disposed on a surface different from the surface on which the protrusion 154 is disposed.

87. The auto-injector 10 of any one or more of the above embodiments, further comprising a needle guard 18, wherein axial movement of the needle guard 18 toward the drive chassis 24 unlocks the drive chassis 24 relative to the housing 12.

88. The automatic injector 10 of embodiment 87, wherein the needle guard 18 includes a blocking rib 144.

89. The automatic injector 10 of embodiment 87 or embodiment 88, wherein the needle guard 18 engages the trigger arm 36 as it moves axially toward the drive chassis 24.

90. The automatic injector 10 of any one of embodiments 87 to 89 and embodiment 85, wherein the needle guard 18 includes an engagement surface 146 configured to engage the web 148 of the trigger arm 36.

91. The automatic injector 10 of embodiment 88 or embodiment 89 and embodiment 90, wherein the engagement surface 146 protrudes from the rib.

92. The automatic injector 10 according to any one of embodiments 80 to 86, wherein the web 148 includes a deflection surface 150 that is inclined relative to the direction of movement of the drive chassis 24.

93. The automatic injector 10 according to any one of embodiments 85 to 87, wherein the engagement surface 146 is inclined relative to the direction of movement of the drive chassis 24.

94. The automatic injector 10 of embodiment 92 and embodiment 93, in which the engagement surface 146 and the deflection surface 150 are cooperatively inclined relative to the direction of movement of the drive chassis 24.

95. The automatic injector 10 according to any one of embodiments 78 to 94, wherein the drive spring 74 is configured to drive the drive chassis 24 towards the needle guard 18 after actuation of the automatic injector 10.

96. The auto-injector 10 according to one or more of the above embodiments, wherein the drive chassis 24 further comprises a plunger support 44 that engages the piston of the pre-filled syringe 16.

97. The automatic injector of embodiment 96, in which relaxation of the drive spring 74 drives the plunger support 44 toward the plunger 26 of the prefilled syringe 16.

98. An auto-injector according to one of the above embodiments, wherein the drive chassis 24 is of a generally U-shaped design.

99. The auto-injector of one or more of the above embodiments, wherein the trigger arm 36, the drive chassis 24, and the plunger support 44 are formed in one piece from the same material.

100. An auto-injector 10, optionally according to one or more of the above embodiments, comprising a pre-filled syringe 16 disposed within the housing 12 of the auto-injector 10, a needle shield 78 covering the needle 34 of the pre-filled syringe 16 during a storage phase of the auto-injector 10, an axially movable needle guard 18 arranged to cover the needle 34 of the pre-filled syringe 16 at least after use of the auto-injector 10 and to move relative to the pre-filled syringe 16 during use of the auto-injector 10, and a removable cap 70 into which the needle guard 18 is stored during a storage phase of the auto-injector 10, wherein the cap 70 is removably connected to the needle guard 18 during the storage phase of the auto-injector 10, and wherein removal of the cap 70 also removes the needle shield 78 from the auto-injector 10.

101. The auto-injector of any one or more of the above embodiments, wherein the needle guard 18 is connected to the cap 70 via one or more snap-fit connections 94.

102. The automatic injector of embodiment 101, wherein each snap-fit connection 94 includes a snap-fit protrusion 96 that cooperates with a corresponding snap-fit area 98.

103. The automatic injector of embodiment 102, wherein one or more snap-fit protrusions 96 are provided on the outer surface 126 of the needle guard 18.

104. An automatic injector as described in embodiment 101 or embodiment 102, in which one or more snap-fit areas 98 are provided on an inner surface of the cap 70.

105. The automatic injector according to one or more of the above embodiments, wherein the outer wall 116 of the cap 70 contacts the outer wall 136 of the housing 12 during the retraction phase of the automatic injector 10.

106. The automatic injector according to embodiment 105, wherein the outer wall 116 of the cap 70 and the outer wall 136 of the housing 12 do not overlap in the axial direction of the automatic injector 10.

107. The automatic injector according to embodiment 105 or embodiment 106, in which the outer wall 116 of the cap 70 and the outer wall 136 of the housing 12 overlap radially during the storage phase of the automatic injector 10.

108. The auto-injector of one or more of the above embodiments, wherein the cap 70 prevents axial movement of the needle guard 18 when attached to the needle guard 18 during the retraction phase.

109. The auto-injector of one or more of the above embodiments, wherein the needle shield 78 is disposed within the inner wall of the cap 70 during the retraction phase of the auto-injector 10.

110. The auto-injector of any one or more of the above embodiments, wherein the front end of the needle guard 18 is disposed within the opening 124 of the cap 70.

111. The automatic injector of any one or more of the above embodiments, wherein the front end 122 of the needle guard 18 is disposed within an opening 124 of the cap 70, the opening 124 being formed between the outer wall 116 of the cap 70 and an inner wall of the cap 70.

112. The automatic injector of any one or more of the above embodiments, wherein the front end 122 of the needle guard 18 is disposed within the opening 124 of the cap 70, and the front end 122 of the needle guard 18 includes the one or more snap-fit protrusions 96.

113. The automatic injector of any one of the above embodiments, wherein the inner surface 128, 132 of the housing 12 includes one or more grooves 130, 134 in which one or more of the snap-fit protrusions 96 can move axially relative to the housing 12 upon movement of the needle guard 18.

114. The auto-injector of any one or more of the above embodiments, wherein the axially movable needle guard 18 is arranged to move relative to the housing 12 during use of the auto-injector 10.

115. The auto-injector of one or more of the above embodiments, wherein the cap 70 is of a single piece design.

116. The auto-injector of any one or more of the above embodiments, wherein the cap 70 includes an inwardly facing protrusion 108 on the needle guard-facing end 102 that engages the syringe-facing surface 110 of the needle shield 78.

117. The auto-injector of one or more of the above embodiments, wherein the inner wall 106 of the cap 70 includes two windows 112.

118. The automatic injector 10 of embodiments 116 and 117, wherein each protrusion 108 is disposed in a window 112.

119. The automatic injector 10 of one or more of the above embodiments, wherein the recess 114 is formed in the inner wall of the cap 70.

120. The auto-injector 10 of one or more of the above embodiments, wherein the inner surface 118 of the outer wall 116 of the cap 70 includes one or more ribs 120.

121. The auto-injector 10 of one or more of the above embodiments, wherein the cap 70 comprises a stand for the auto-injector 10.

123. The auto-injector 10 of any one or more of the above embodiments, wherein axial movement of the needle guard 18 in the direction of the prefilled syringe 16 results in engagement of a release mechanism 40 of the plunger 26 of the prefilled syringe 16, which administers the substance stored in the prefilled syringe 16.

124. The auto-injector 10, optionally according to one or more of the above embodiments,
a housing 12 in which a prefilled syringe 16 is disposed;
a drive chassis 24 mounted to the housing 12, the drive chassis 24 being biased against the housing 12 and being fixed relative to the housing 12 during a storage phase of the automatic injector 10;
The automatic injector 10 further comprises a status indicator window 20 disposed in the housing 12, through which the drive chassis 24 is visible from the outside, the status indicator window 20 showing a first part 50 of the drive chassis 24 in a storage stage of the automatic injector 10 and a second part 52 of the drive chassis 24 after use of the automatic injector 10, such that the first part 50 and the second part 52 of the drive chassis 24 can be distinguished from each other.

125. The automatic injector 10 of embodiment 124, wherein the status indicator window 20 is formed by an elongated slot extending radially around a portion of the housing 12.

126. The autoinjector 10 of embodiment 124 or embodiment 125, wherein the first portion 50 and the second portion 52 of the drive chassis 24 are distinguishable from each other by differences in color, a printed label applied to the surface of the drive chassis 24, text applied to the surface 49 of the drive chassis 24, and/or an icon displayed on the surface of the drive chassis 24.

127. The auto-injector 10 of any one or more of the above embodiments, further comprising a syringe window 14 through which the prefilled syringe 16 is externally visible.

128. The automatic injector 10 of embodiment 127, wherein the syringe window 14 shows the contents filled in the prefilled syringe 16 during the storage phase of the automatic injector 10.

129. The automatic injector 10 of embodiment 127 or embodiment 128, wherein the syringe window 14 shows at least one of the plunger 26 disposed within the prefilled syringe 16 and the portion of the dosing rim 22 that is within the prefilled syringe 16 after use of the automatic injector 10.

130. The automatic injector 10 according to any one of embodiments 127 to 129, wherein the syringe window 14 is disposed in the housing 12.

131. The automatic injector 10 according to any one of embodiments 127 to 130, wherein the syringe window 14 is elongated in shape, the length of the elongated shape extending in the axial direction of the automatic injector 10.

132. The autoinjector 10 according to any one of embodiments 127 to 131, wherein the syringe window is disposed transversely to the status indicator window 20.

134. The autoinjector 10 of any one of embodiments 127 to 132, wherein the syringe window indicates a different portion of the drive chassis 24 compared to the status indicator window 20.

135. The auto-injector 10 of any one or more of the above embodiments, wherein the drive chassis 24 includes a trigger arm 36 that engages an opening 138 in the housing 12 during a retraction phase of the auto-injector 10.

136. The auto-injector 10 of any one or more of the above embodiments, further comprising a needle guard 18, wherein axial movement of the needle guard 18 toward the drive chassis 24 unlocks the drive chassis 24 relative to the housing 12.

137. The automatic injector 10 of embodiment 136, wherein the needle guard 18 includes a plunger arm 142.

138. The automatic injector 10 of embodiment 136 or embodiment 137, wherein the needle guard 18 engages the trigger arm 36 as it moves axially toward the drive chassis 24.

139. The automatic injector 10 of embodiment 137 or embodiment 138, wherein the plunger arm 142 of the needle guard 18 engages the trigger arm 36 as it moves axially toward the drive chassis 24.

140. The auto-injector 10 of any one or more of the above embodiments, further comprising a drive spring 74 mounted between the housing 12 and the drive chassis 24.

141. The automatic injector 10 of embodiment 140, wherein the spring is configured to drive the drive chassis 24 toward the needle guard 18 after actuation of the automatic injector 10.

141. The auto-injector 10 according to one or more of the above embodiments, wherein the drive chassis 24 further comprises a plunger support 44 that engages the piston of the pre-filled syringe 16.

142. The automatic injector 10 of embodiment 139 or embodiment 140 and embodiment 141, wherein relaxation of the drive spring 74 drives the plunger support 44 toward the piston of the prefilled syringe 16.

143. The auto-injector 10 of one or more of the above embodiments, wherein the drive chassis 24 is of a generally U-shaped design.

144. The auto-injector 10 of one or more of the above embodiments, wherein the trigger arm 36, the drive chassis 24, and the plunger support 44 are formed in one piece from the same material.

145. An auto-injector 10, optionally according to one or more of the above embodiments, comprising a drive chassis 24, the drive chassis 24 comprising a dosing rim 22 and a trigger rim 32, a plunger 26 disposed at a proximal end of the dosing rim 22, a trigger arm 36 disposed extending proximally from the trigger rim 32, the trigger rim 32 and the dosing rim 22 disposed parallel to each other, at least essentially parallel to each other, and connected to each other at the distal side of the dosing rim 22 and the trigger rim 32, respectively.

146. The automatic injector 10 of embodiment 145, in which the trigger rim 32, the dose rim 22, the plunger support 44, and the trigger arm 36 are integrally formed in one piece.

147. The automatic injector 10 of embodiment 145 or embodiment 146, wherein the trigger arm 36 is biased against the housing 12 of the automatic injector 10 during a retraction phase of the automatic injector 10.

148. The auto-injector 10 of one or more of the above embodiments, wherein the trigger arm 36 is deflected when moving the auto-injector 10 from a retracted stage to an actuated stage of the auto-injector 10.

149. The auto-injector 10 of one or more of the above embodiments, wherein the trigger arm 36 is actuated by the needle guard 18 of the auto-injector 10 when the auto-injector 10 moves from the retracted stage to the actuated stage of the auto-injector 10.

150. The auto-injector 10 according to one or more of the above embodiments, wherein the plunger support 44 is configured to act on the pre-filled syringe 16 of the auto-injector 10.

151. The auto-injector 10 of any one or more of the above embodiments, further comprising a drive spring 74.

152. The automatic injector 10 of embodiment 151, wherein the drive spring 74 is disposed within the housing 12 of the automatic injector 10 between the distal housing wall 84 and the drive chassis 24.

153. The automatic injector 10 of embodiment 152, wherein the drive spring 74 biases the trigger arm 36 against the housing 12 of the automatic injector 10 during a retraction phase of the automatic injector 10.

154. The automatic injector 10 according to one of embodiments 152 to 153, wherein the drive spring 74 is configured to drive the plunger 26 of the automatic injector 10 within the pre-filled syringe 16 of the automatic injector 10.

155. The auto-injector 10 of one or more of the above embodiments, wherein the drive chassis 24 is linearly guided within the housing 12 of the auto-injector 10 as the auto-injector 10 moves from the retracted stage to the activated stage of the auto-injector 10.

156. The auto-injector 10 of any one or more of the above embodiments, wherein the trigger arm 36 is configured to move radially and transversely relative to the trigger rim 32.

156. The auto-injector 10 of any one or more of the above embodiments, wherein the trigger arm 36 is configured to cooperate with a stop mechanism 54 disposed on the housing 12 during a retraction phase of the auto-injector 10.

158. The auto-injector 10 of any one or more of the above embodiments, wherein the trigger rim 32 and the dose rim 22 are each at least approximately U-shaped.

159. The automatic injector 10 of any one or more of the above embodiments, wherein the trigger rim 32 further comprises at least a first portion 56 of an audible end-of-dose feedback member 58.

160. The automatic injector 10 of embodiment 159, further comprising a housing 12, the housing 12 further comprising at least one second portion 66 of the audible end-of-dosage feedback member 58, and optionally the housing 12 is formed by an outer body 82 and an inner body 80, one of the inner body 80 and the outer body 82 comprising said at least one second portion 66 of the audible end-of-dosage feedback member 58.

161. The automatic injector 10 of embodiment 159 or embodiment 160, wherein the first portion 56 and the second portion 66 of the audible end-of-dose feedback member 58 are formed by a recess 208 and a latching tongue 62 configured to cooperate with the recess 208.

162. The automatic injector 10 of any one of embodiments 159 to 161, wherein the audible end-of-dosage feedback member 58 is configured to emit a sound when the substance is dispensed from the automatic injector 10.

163. The automatic injector 10 of any one of embodiments 159 to 162, wherein the audible end-of-dose feedback member 58 is configured to emit a sound between the drive chassis 24 and the housing 12 when the substance is dispensed from the automatic injector 10.

164. The auto-injector 10 of any one or more of the above embodiments, wherein the inner body 80 further comprises a first notch 174, the first notch 174 configured to cooperate with the clip arm 184 and the lockout arm 186 of the needle guard 18.

165. The automatic injector 10 of embodiment 164, wherein the inner body 80 further comprises a second notch 176, the second notch being configured to cooperate with the lockout arm 186 of the needle guard 18.

166. The auto-injector 10 of any one or more of the above embodiments, wherein the drive chassis 24 further comprises a second trigger arm 36.

167. The automatic injector 10 of embodiment 166, wherein the second trigger arm 36 is disposed on a side of the drive chassis 24 opposite the first trigger arm 36.

168. The auto-injector 10 of any one or more of the above embodiments, wherein the trigger rim 32 includes a passageway 140 formed therein.

169. The automatic injector 10 of embodiment 168, wherein the passage 140 is configured to receive at least a portion of the drive spring 74.

170. The auto-injector 10 of any one or more of the above embodiments, wherein the trigger rim 32 includes a lip 216 at an end disposed opposite the web 42.

171. The automatic injector 10 of embodiment 170, wherein the lip 216 is configured to engage a clip arm 184 formed on the needle guard 18.

172. The automatic injector 10 of embodiment 170 or embodiment 171, wherein the lip 216 has two tips 218, each tip 218 configured to engage a respective one of the clip arms 184 formed on the needle guard 18.

173. The auto-injector 10 of any one or more of the above embodiments, wherein the needle shield 78 includes a needle receptacle 212 configured to receive the needle 34 of the prefilled syringe 16.

174. The auto-injector 10 of any one or more of the above embodiments, wherein the cap 70 includes a needle shield holder 104 configured to receive the needle shield 78.

175. The auto-injector 10 of any one or more of the above embodiments, wherein the needle guard 18 further comprises one or more lockout arms 186.

176. The automatic injector 10 of embodiment 175, wherein one or more lockout arms 186 are configured to cooperate with the inner body 80.

177. The automatic injector 10 of embodiment 175 or embodiment 176, wherein the one or more lockout arms 186 are configured to engage one or more bars 178 of the inner body 80 during the lockout phase.

178. The auto-injector 10 according to any one of embodiments 175 to 177, wherein the one or more lockout arms 186 are configured to engage respective ones of the one or more notches 176 in the inner body 80 during the lockout phase.

179. The auto-injector 10 according to any one of embodiments 175 to 178, wherein the one or more lockout arms 186 are configured to engage one or more additional notches 174 in the inner body 80 during the administration and retraction phases.

180. The auto-injector 10 of any one or more of the above embodiments, wherein the needle guard 18 further comprises one or more clip arms 184.

181. The automatic injector 10 of embodiment 180, wherein the one or more clip arms 184 are configured to cooperate with a respective one of the one or more notches 174 of the inner body 80 during the administration phase.

182. The automatic injector 10 of embodiment 180 or embodiment 181, wherein the one or more clip arms 184 are biased inwardly and abut the inner surface 132 of the inner body 80 during the lockout phase.

183. The autoinjector 10 according to any one of embodiments 180 to 182, wherein the one or more clip arms 184 are configured to be biased inwardly by the drive chassis 24 upon proximal movement of the drive chassis 24.

184. The auto-injector 10 of any one or more of the above embodiments, wherein the needle guard 18 further comprises a plunger arm 142.

185. The automatic injector 10 of embodiment 184, wherein the plunger arm 142 includes one or more blocking ribs 144 disposed at its distal end.

186. The automatic injector 10 of embodiment 185, wherein the plunger arm 142 has two block ribs 144, the two block ribs 144 being disposed opposite each other.

187. The automatic injector 10 of embodiment 185 or embodiment 186, wherein one or more blocking ribs 144 are configured to block radial movement of the trigger arm 36 during the retraction phase.

188. The automatic injector 10 according to any one of embodiments 184 to 187, wherein the plunger arm 142 includes one or more cams 162.

189. The automatic injector 10 of embodiment 188, wherein the one or more cams 162 are configured to engage one or more trigger arms 36 of the drive chassis 24 upon actuation of the automatic injector 10.

190. The automatic injector 10 of embodiment 189, wherein one or more cams 162 are configured to pull one or more trigger arms 36 of the drive chassis 24 in the transverse direction T upon actuation of the automatic injector 10.

191. The auto-injector 10 of any one or more of the above embodiments, wherein the needle guard 18 includes one or more protrusions 166 that cooperate with respective ones of the one or more elongated holes 168 present in the inner body 80.

192. The automatic injector 10 of embodiment 191, in which one or more protrusions 166 are provided to ensure linear guidance of the needle guard 18 relative to the inner body 80.

193. The auto-injector 10 of any one or more of the above embodiments, wherein the needle guard 18 further comprises one or more retention mechanisms 170.

194. The automatic injector 10 of embodiment 193, wherein one or more retention mechanisms 170 are configured to prevent removal of the needle guard 18 from the proximal end of the housing 12.

195. The automatic injector 10 of embodiment 194, wherein the inner body 80 includes one or more elongated holes 168 each having a proximal stop 172 that prevents a respective one of the projections 166 from moving proximally beyond the stop 172.

196. The auto-injector 10 of any one or more of the above embodiments, wherein the inner body 80 of the housing 12 further comprises at least one portion 66 of the audible end-of-dose feedback member 58.

197. The automatic injector 10 of embodiment 196, wherein the portion 66 of the audible end-of-dose feedback member 58 comprises an inner body recess 206 having a distal surface 196 and a proximal surface 198 surrounding the inner body recess 206.

198. The auto-injector 10 of any one or more of the above embodiments, wherein the inner body 80 includes one or more notches 174, 176.

199. The automatic injector 10 of embodiment 198 and embodiment 196 or 197, wherein the one or more notches 174, 176 are disposed at an end of the inner body 80 disposed opposite the second portion 66 of the audible end-of-dose feedback member 58.

200. The auto-injector 10 of any one or more of the above embodiments, wherein the outer body 82 includes one or more stop mechanisms 54.

201. The automatic injector 10 of embodiment 200, wherein each stop mechanism 54 is provided at each opening 138.

202. The automatic injector 10 of embodiment 200 or embodiment 201, wherein each stop mechanism 54 is a component of a respective release mechanism 40 of the automatic injector 10.

203. The auto-injector 10 of any one or more of the above embodiments, wherein the outer surface 49 of the trigger rim 32 includes a first partial outer surface 50 and a second partial outer surface 52 that differ in appearance from each other.

204. The auto-injector 10 according to one or more of the above embodiments, wherein the block 184' of the clip arm 184 is disposed between the lockout surface 234 and the extended abutment surface during a lockout phase of the auto-injector 10.

205. The auto-injector 10 of any one or more of the above embodiments, wherein the block 184' of the clip arm 184 is movably disposed within the aperture 174' of the inner body 80.

205. The auto-injector 10 of any one or more of the above embodiments, wherein the block 184' of the clip arm 184 is movably disposed within the long rim 238 and the short rim 236 of the aperture 174' of the inner body 80.

206. The auto-injector 10 of any one or more of the above embodiments, wherein each trigger arm 36 is configured to engage a respective one of the clip arms 184 to lock the needle guard during a lockout phase.

207. The auto-injector 10 of any one or more of the above embodiments, wherein the axial height of the notch defines a range of movement of the needle guard 18 along the axial direction A.

208. A method of actuating an automatic injector 10, optionally according to one or more of the above embodiments, comprising:
Releasing the snap-fit connection 94 between the cap 70 and the needle guard 18;
and axially moving the cap 70 away from the needle guard 18, thereby simultaneously removing the needle shield 78 from the pre-filled syringe 16.

209. A method of assembling an auto-injector 10, optionally according to one or more of the above embodiments, comprising:
Providing a pre-filled syringe 16;
providing a needle shield 78;
covering the needle 34 of the prefilled syringe 16 with a needle shield 78;
and inserting the needle shield 78 and the needle 34 into the cap 70.

10 automatic injector 12 housing 14 syringe window 16 prefilled syringe 18 needle guard 20 status indicator window 22 dosing rim 24 drive chassis 26 plunger 28 proximal end 30 distal end 32 trigger rim 34 needle 36 trigger arm 38 distal end of 24 40 release mechanism 42 web 44 plunger support 46, 46' first guide aid, first groove 48, 48' second guide aid, second groove 49 outer surface of 32 50 first portion outer surface of 32 52 second portion outer surface of 32 54 stop mechanism 56 first portion of audible feedback member 58 audible feedback member 60 nose 62 tongue 64 recess 66 second portion of audible feedback member 58 68 opening 70 cap 72 connection between 80 and 82 74 drive spring 76 lockout spring 78 removable needle shield 80 inner body 12 82 outer body 12 84 distal wall 12 86 protrusion 84 88 end wall 18 90 protrusion 28 91 aperture 80 92 proximal end 80 94 snap-fit connection 96 snap-fit protrusion 98 snap-fit area 100 base 102 end facing needle guard 104 needle shield holder 106 inner wall 104 108 protrusion 104 110 surface facing syringe 112 window 114 recess 116 outer wall 70 118 inner surface 116 120 rib 122 Front end of 18 124 opening 126 exterior surface of 18 128 interior surface of 82 130 groove of 82 132 interior surface of 80 134 groove of 80 136 exterior wall of 12 138 opening 140 passage in 32 142 plunger arm 144 blocking rib 146 engagement surface 148 web 150 deflection surface 152 convex surface 154 projection of 36 156 first flat surface of 54 158 second flat surface of 54 160 apex between 156 and 158 162 cam 164 lug 166 projection 168 slot 170 retention feature 172 stop 174 first notch 174' aperture 176 second notch 178 bar 180 first portion of 174 182 second portion of 174 184 clip arm 184' block of 184 186 lockout arm 188 nose 190 window 192 distal stop 194 inner body assembly stop mechanism 196 distal surface 198 proximal surface 200 ramp surface 202 click surface 204 distal inner housing end 206 inner body recess 208 first snap-fit area 210 second snap-fit area 212 needle receptacle 214 front end of 78 216 lip 218 tip of 216 220 engagement portion 222 ramp of 220 224 flat portion 226 chamfered surface 228 lug 230 sleeve 232 Extension slot 234 lockout surface 236 short rim 238 long rim 240 surface 184' 242 assembly abutment surface 244 extended abutment surface 246 assembly stop mechanism 18 248 end-of-dose ramp 24 250 end-of-dose click arm 80 252 clip 254 barb 256 projection 258 syringe rib 260 syringe ring flange 262 concave surface 36 264 first flat portion 262 266 second flat portion 262 268 drop between 264 and 266 270 rib 80 272 support at 82 A axial B arrow M drug R radial T transverse

Claims (44)

An automatic injector (10), comprising:
A housing (12);
a pre-filled syringe (16) mounted within and fixed relative to the housing (12);
a needle guard (18) axially movably mounted within said housing (12) for movement between a storage phase, an administration phase, and a lockout phase, said needle guard (18) assuming different axial positions relative to said housing (12) during said storage phase, said administration phase, and said lockout phase, said needle guard (18) comprising one or more clip arms (184) configured to engage corresponding notches (174, 174') in said housing (12) of said automatic injector (10) during said storage phase;
a drive chassis (24) biased relative to the housing (12), the drive chassis (24) being further configured to be fixed relative to the housing (12) and to move relative to the housing (12) during a storage phase of the automatic injector (10) and to axially move and act on the pre-filled syringe (16) during administration, the drive chassis (24) comprising one or more trigger arms (36);
a respective one of the one or more trigger arms (36) configured to engage a respective one of one or more clip arms (174, 174') of the needle guard (18) upon proximal movement of the needle guard (18) between the administering stage and the lockout stage;
the drive chassis (24) is configured to prevent the one or more clip arms (184) from engaging the housing (12) during release of the needle guard (18) when the automatic injector (10) transitions from the administration phase to the lockout phase;
Auto-injector (10). a lockout spring (76) disposed between said needle guard (18) and said housing (12), and optionally
the needle guard (18) is configured to compress the lockout spring (76) when moving between the retraction stage and the administration stage, and the needle guard (18) is configured to move between the administration stage and the lockout stage by relaxing the lockout spring (76).
The automatic injector (10) of claim 1. the needle guard (18) moves axially towards the drive chassis (24) to unlock the drive chassis (24) from the housing (12) upon actuation of the automatic injector (10);
3. An automatic injector (10) according to claim 1 or 2. a release mechanism (40) comprising the one or more trigger arms (36) disposed on the drive chassis (24), the one or more trigger arms (36) cooperating with respective stop mechanisms (54) disposed on the housing (12), and a plunger arm (142) configured to deflect the one or more trigger arms (36) upon axial movement of the needle guard (18) in a distal direction;
An automatic injector (10) according to any one of claims 1 to 3. the one or more clip arms (184) each have a block at an end thereof, the block being configured to engage a lockout surface of the notch (174, 174') in the housing (12) of the automatic injector (10) during the lockout phase;
An automatic injector (10) according to any one of claims 1 to 4. each of said notches (174, 174') being at least approximately L-shaped, with a lockout surface disposed on a short rim of said L-shaped notches (174, 174');
An automatic injector (10) according to any one of claims 1 to 5. The automatic injector (10) of claim 6, wherein the lockout surface is disposed at an angle to the long rim of the L-shaped cutout (174, 174'). The automatic injector (10) according to claims 6 and 7, wherein the short and long limbs of the L-shaped notch (174, 174') are arranged at an angle to each other, the angle being selected within the range of 10 to 120°, in particular 20 to 80°. The automatic injector (10) of any one of claims 1 to 8, wherein the one or more clip arms (184) extend proximally from the needle guard (18). The automatic injector of any one of claims 1 to 9, wherein the one or more clip arms (184) extend proximally from a plunger arm (142) of the needle guard (18). the needle guard (18) includes a plunger arm (142) that activates a release mechanism (40) of the automatic injector (10);
the release mechanism (40) is disposed between the housing (12) and the drive chassis (24) of the automatic injector;
11. An automatic injector according to any one of claims 1 to 10. The automatic injector of any one of claims 1 to 11, wherein the needle guard (18) comprises a sleeve (230) at the proximal end (92). 13. The automatic injector of claim 12, wherein the needle guards (18) are each at least approximately T-shaped in design and the plunger arms (142) are arranged parallel to the axis (A) of the automatic injector (10) from the proximal end (92) to the distal end of the sleeve (230). The automatic injector of claim 12 or claim 13, wherein the sleeve (230) comprises one or more elongated slots (232) extending parallel to the axis (A) of the automatic injector (10) from the proximal end (92) to the distal end of the sleeve (230). The automatic injector of any one of claims 1 to 14, wherein the housing (12) comprises an inner body (80) and an outer body (82), and the notches (174, 174') are disposed in the inner body (180). An automatic injector (10), comprising:
A housing (12);
a pre-filled syringe (16) mounted within and fixed relative to the housing (12);
a needle guard (18) axially movably mounted within said housing (12) for movement between a storage phase, an administration phase, and a lockout phase, said needle guard (18) assuming different axial positions relative to said housing (12) during said storage phase, said administration phase, and said lockout phase, said needle guard (18) comprising one or more clip arms (184) configured to engage corresponding notches (174, 174') in said housing (12) of said automatic injector (10) during said storage phase;
a drive chassis (24) biased relative to the housing (12), the drive chassis (24) being further configured to be fixed relative to the housing (12) and to move relative to the housing (12) during a storage phase of the automatic injector (10) and to axially move and act on the pre-filled syringe (16) during administration;
the needle guard (18) is configured for axial movement in a distal direction between the retraction stage and the administration stage;
the needle guard (18) is configured for axial movement in a proximal direction between the administering stage and the lockout stage;
the needle guard (18) includes a plunger arm (142) that activates a release mechanism (40) of the automatic injector (10);
the release mechanism (40) is disposed between the housing (12) and the drive chassis (24) of the automatic injector;
Auto-injector (10). a lockout spring (76) disposed between said needle guard (18) and said housing (12), and optionally
the needle guard (18) is configured to compress the lockout spring (76) when moving between the retraction stage and the administration stage, and the needle guard (18) is configured to move between the administration stage and the lockout stage by relaxing the lockout spring (76).
17. The automatic injector (10) according to claim 16. the needle guard (18) moves axially towards the drive chassis (24) to unlock the drive chassis (24) from the housing (12) upon actuation of the automatic injector (10);
18. An automatic injector (10) according to any one of the preceding claims. the release mechanism (40) comprises one or more trigger arms (36) disposed on the drive chassis (24), the one or more trigger arms (36) cooperating with respective stop mechanisms (54) disposed on the housing (12), and the plunger arm (142) configured to bias the one or more trigger arms (36) upon axial movement of the needle guard (18) in a distal direction;
19. An automatic injector (10) according to any one of claims 1 to 18. the one or more clip arms (184) each have a block at an end thereof, the block being configured to engage a lockout surface of the notch (174, 174') in the housing (12) of the automatic injector (10) during the lockout phase;
20. An automatic injector (10) according to any one of claims 1 to 19. each of said cutouts (174, 174') being at least approximately L-shaped, said lockout surface being disposed on a short rim of said L-shaped cutouts (174, 174');
21. An automatic injector (10) according to any one of claims 1 to 20. 22. The automatic injector (10) of claim 21, wherein the lockout surface is disposed at an angle to the long rim of the L-shaped cutout (174, 174'). The automatic injector (10) according to claims 21 and 22, wherein the short and long limbs of the L-shaped notch (174, 174') are arranged at an angle to each other, the angle being selected within the range of 10 to 120°, in particular 20 to 80°. 24. The automatic injector (10) of any one of claims 1 to 23, wherein the one or more clip arms (184) extend proximally from the needle guard (18). 25. The automatic injector of claim 1, wherein the one or more clip arms (184) extend proximally from the plunger arm (142) of the needle guard (18). 26. The automatic injector of any one of claims 18 to 25, wherein a respective one of the one or more trigger arms (36) is configured to engage a respective one of the one or more clip arms (174, 174') when the needle guard (18) is moved in the proximal direction between the administration stage and the lockout stage. 27. The automatic injector of claim 1, wherein the needle guard (18) comprises a sleeve (230) at the proximal end (92). 28. The automatic injector of claim 27, wherein the needle guards (18) are each at least approximately T-shaped in design and the plunger arms (142) are arranged parallel to the axis (A) of the automatic injector (10) from the proximal end (92) to the distal end of the sleeve (230). 29. The automatic injector of claim 27 or 28, wherein the sleeve (230) comprises one or more elongated slots (232) extending parallel to the axis (A) of the automatic injector (10) from the proximal end (92) to the distal end of the sleeve (230). An automatic injector (10), comprising:
A housing (12);
a pre-filled syringe (16) mounted within and fixed relative to the housing (12);
a needle guard (18) axially movably mounted within said housing (12) for movement between a retraction phase, an administration phase and a lockout phase, said needle guard (18) assuming different axial positions relative to said housing (12) during said retraction phase, said administration phase and said lockout phase, said needle guard (18) comprising one or more clip arms (184) configured to engage corresponding notches (174, 174') in said housing (12) of said automatic injector (10) during said retraction phase;
a drive chassis (24) biased relative to the housing (12), the drive chassis (24) being further configured to be fixed relative to the housing (12) and to move relative to the housing (12) during a storage phase of the automatic injector (10) and to axially move and act on the pre-filled syringe (16) during administration;
the needle guard (18) is configured for axial movement in a distal direction between the retraction stage and the administration stage;
the needle guard (18) is configured for axial movement in a proximal direction between the administering stage and the lockout stage;
the needle guard (18) includes a plunger arm (142) that activates a release mechanism (40) of the automatic injector (10);
the release mechanism (40) is disposed between the housing (12) and the drive chassis (24) of the automatic injector;
Auto-injector (10). a lockout spring (76) disposed between said needle guard (18) and said housing (12), and optionally
the needle guard (18) is configured to compress the lockout spring (76) when moving between the retraction stage and the administration stage, and the needle guard (18) is configured to move between the administration stage and the lockout stage by relaxing the lockout spring (76).
31. The automatic injector (10) according to claim 30. the needle guard (18) moves axially towards the drive chassis (24) to unlock the drive chassis (24) from the housing (12) upon actuation of the automatic injector (10);
32. The automatic injector (10) according to claim 30 or 31. the release mechanism (40) comprises one or more trigger arms (36) disposed on the drive chassis (24), the one or more trigger arms (36) cooperating with respective stop mechanisms (54) disposed on the housing (12), and the plunger arm (142) configured to bias the one or more trigger arms (36) upon axial movement of the needle guard (18) in a distal direction;
33. An automatic injector (10) according to any one of claims 30 to 32. the one or more clip arms (184) each have a block at an end thereof, the block being configured to engage a lockout surface of the notch (174, 174') in the housing (12) of the automatic injector (10) during the lockout phase;
34. An automatic injector (10) according to any one of claims 30 to 33. said notches (174, 174') are each at least approximately L-shaped, and a lockout surface is disposed on a short rim of said L-shaped notches (174, 174');
35. An automatic injector (10) according to any one of claims 30 to 34. 36. The automatic injector (10) of claim 35, wherein the lockout surface is disposed at an angle to the long rim of the L-shaped cutout (174, 174'). The automatic injector (10) according to claims 35 and 36, wherein the short and long limbs of the L-shaped notch (174, 174') are arranged at an angle to each other, the angle being selected within the range of 10 to 120°, in particular 20 to 80°. The automatic injector (10) of any one of claims 1 to 37, wherein the one or more clip arms (184) extend proximally from the needle guard (18). The automatic injector of any one of claims 1 to 38, wherein the one or more clip arms (184) extend proximally from the plunger arm (142) of the needle guard (18). The automatic injector of any one of claims 33 to 39, wherein a respective one of the one or more trigger arms (36) is configured to engage a respective one of the one or more clip arms (174, 174') when the needle guard (18) is moved in the proximal direction between the administration stage and the lockout stage. The automatic injector of any one of claims 1 to 40, wherein the needle guard (18) comprises a sleeve (230) at the proximal end (92). 42. The automatic injector of claim 41, wherein the needle guards (18) are each at least approximately T-shaped in design and the plunger arms (142) are arranged parallel to the axis (A) of the automatic injector (10) from the proximal end (92) to the distal end of the sleeve (230). The automatic injector of claim 41 or claim 42, wherein the sleeve (230) comprises one or more elongated slots (232) extending parallel to the axis (A) of the automatic injector (10) from the proximal end (92) to the distal end of the sleeve (230). The automatic injector of any one of claims 1 to 43, wherein the housing (12) comprises an inner body (80) and an outer body (82), and the notches (174, 174') are disposed in the inner body (180).

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