Prefilled syringe systems and methods

Abstract

The present invention relates to prefilled syringes and methods of use and injection thereof. An embodiment provides a prefilled syringe system for controlled injection depth in a subject, comprising: a prefilled syringe having a needle tip and a plunger for injecting the contents of the prefilled syringe; a housing for accommodating the prefilled syringe and the needle tip at a defined position of the injection depth; and a needle shield mounted on the housing for releasable movement from a locked injection position to a protected position, wherein after the needle shield is moved to the locked injection position and the needle tip extends out of the needle shield and the prefilled syringe system, the needle can be inserted into the subject at a defined injection depth. An embodiment also provides a method of injecting a subject using a prefilled syringe system, comprising providing a prefilled syringe system having a housing, a needle shield mounted on the housing, and a prefilled syringe with a needle tip; moving the needle shield mounted on the housing to the locked injection position to extend the needle tip of the prefilled syringe and the system out of the needle shield and the prefilled syringe system by a defined length; inserting the needle tip of the prefilled syringe and the system into the subject at a defined injection depth, and injecting the contents of the prefilled syringe and the system into the subject.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This application claims the benefit of U.S. Provisional Patent Application No. 63 / 010,232, filed on April 15, 2020, the disclosure of which is hereby incorporated by reference in its entirety. Background Art

[0003] The pharmaceutical industry uses a variety of devices and methods to deliver drugs. Prefilled syringes are a method of quickly and easily delivering drugs directly into the bloodstream and achieving maximum efficacy. However, subcutaneous injection using prefilled syringes does present challenges in both the injection device and the method. For example, self-injection using a prefilled syringe requires the user to find and maintain a 45-degree angle when inserting the needle into their own skin. In addition, in many cases, the user is also required to maintain a skin fold when injecting themselves. This can be difficult to get right, and if the wrong angle is obtained, the needle may penetrate too deep. In addition, in many prefilled syringe embodiments, there is no possible way to control the depth of needle insertion. This can cause the needle to penetrate too deep, causing pain, injury, and exposure to skin or blood complications. In addition, many prefilled syringe devices in the art do not provide needle protection to help eliminate needle sticks after the needle injection is completed. Needle sticks after injection are a problem in the pharmaceutical industry.

[0004] Pre-filled syringes that exist in the art also have challenges in their use. For example, in almost all known devices, the user must first insert the needle with their thumb and index finger against the syringe barrel, squeezing the syringe barrel as they insert the needle. Next, in order to perform the injection, the hand must be repositioned and reoriented to perform the final injection while the needle is in the patient. In some cases, incorrect injections require repeated attempts to perform the final injection. Therefore, the devices and methods present many challenges to performing a correct and effective injection.

[0005] Therefore, in the face of these and other challenges in the industry, there is a continuing need for pre-filled syringes and methods that do not require the patient to inject at a forty-five degree angle.

[0006] There is also a need for pre-filled syringes, systems and methods for controlling needle insertion and injection depth.

[0007] Additionally, there is a need for pre-filled syringes and systems that do not require the patient to reposition the needle when the needle becomes stuck therein.

[0008] Additionally, there is a need for pre-filled syringes and systems wherein the syringe provides needle protection after the injection is complete.

[0009] These and other problems encountered in the art have been solved and eliminated by the present embodiments. Summary of the invention

[0010] Embodiments include pre-filled syringe devices and methods of using the same.

[0011] An embodiment provides a prefilled syringe system for controlled injection depth in a subject, comprising: a prefilled syringe having a needle tip and a plunger for injecting the contents of the prefilled syringe; a housing for containing the prefilled syringe and the needle tip in a defined position for controlling the injection depth; and a needle shield mounted on the housing for movement from a locked injection position to a protected position, wherein after the needle shield moves to the locked injection position and the needle tip extends out of the needle shield and the prefilled syringe system, the needle can be inserted into the subject at a controlled injection depth.

[0012] Embodiments also provide methods for using and injecting a subject using a prefilled syringe and system, including providing a prefilled syringe system having a housing, a needle shield mounted on the housing, and a prefilled syringe with a needle tip; moving the needle shield mounted on the housing to a locked injection position to extend the needle tip of the prefilled syringe and system out of the needle shield and the prefilled syringe system by a defined length; inserting the needle tip of the prefilled syringe and system into the subject at a controlled injection depth, and injecting the contents of the prefilled syringe and system into the subject. BRIEF DESCRIPTION OF THE DRAWINGS

[0013] Those skilled in the art will appreciate that the drawings described below are for illustration only and are not intended to limit the scope of the present teachings or claims in any way.

[0014] Figure 1 A generic pre-filled syringe system is shown.

[0015] Figure 2 An exploded view of the prefilled syringe system is shown, along with how the components are assembled.

[0016] Figure 3 A side view of the needle shield is shown.

[0017] Figure 4A A view of a first end of a needle guard is shown.

[0018] Figure 4B A view of the second end of the needle shield is shown.

[0019] Figure 5 A side view of the housing is shown.

[0020] Fig. 6A The housing and needle shield are shown in a partially assembled, releasable, locked injection position without a pre-filled syringe.

[0021] Figure 6BThe housing and needle shield are shown in a partially assembled and extended protective position without a pre-filled syringe.

[0022] Fig. 7A A cross-sectional view of a pre-filled syringe system and needle tip is shown in a locked injection position.

[0023] Figure 7B A similar cross-sectional view as in 7A is shown, but with the pre-filled syringe system and needle tip in a protected position.

[0024] Fig. 8A The locking mechanism of a pre-filled syringe system with a fixed syringe barrel flange is shown before rotation into the locked position.

[0025] Figure 8B The locking mechanism of a pre-filled syringe system with a fixed syringe barrel flange is shown after it has been rotated into the locked position.

[0026] Figure 8C A cross-sectional view of the locking mechanism of a pre-filled syringe system is shown.

[0027] FIG9 shows a method of injecting a pre-filled syringe system, comprising: Fig.9A System preparation, Fig. 9B Subjects injected, Fig. 9C system and needle removal, and Fig.9D Place the system and needle tip in a protected position. DETAILED DESCRIPTION

[0028] The present disclosure describes embodiments related to pre-filled syringes and methods of using the same.

[0029] definition

[0030] For purposes of interpreting this specification, the following definitions shall apply. If any definition set forth below conflicts with the use of the term in any other document (including any document incorporated by reference), then for purposes of interpreting this specification and its associated claims, the following definition shall always control unless a contrary meaning is expressly indicated (such as in the document in which the term was originally used).

[0031] Where appropriate, terms used in the singular also include the plural and vice versa. Unless otherwise specified or the use of "one or more" is clearly inappropriate, the use of "a" or "an" herein means "one or more".

[0032] Unless otherwise indicated, the use of "or" means "and / or". The use of "includes", "comprising", "including", "includes", "comprising", and "including" are interchangeable and not limiting. The terms "such as", "for example", and "such as" are also not limiting. For example, the term "including" shall mean "including but not limited to".

[0033] As used herein, the term "about" means + / - 10% of the provided unit value.

[0034] As used herein, the term "substantially" refers to a qualitative state that exhibits an overall or approximate degree of a characteristic or property of interest. One of ordinary skill in the biological field will understand that because of the many variables that affect the testing, production, and storage of biological and chemical compositions and materials, and because of the inherent errors of the instruments and equipment used in the testing, production, and storage of biological and chemical compositions and materials, biological and chemical phenomena rarely, if ever, achieve or avoid absolute results. Therefore, the term "substantially" is used herein to capture the potential imperfections inherent in many biological and chemical phenomena.

[0035] Now referring to the accompanying drawings, Figure 1 An overall perspective view of a pre-filled syringe system 1 is shown. The pre-filled syringe system 1 includes: a housing 9, a needle shield 3, and a pre-filled syringe 17. Although the presently described embodiments describe certain components or parts, pre-filled syringe systems 1 having various other components, orientations, or combinations of components or parts may also be designed. In addition, each component may be further designed to fit into and around each other in various orientations and designs.

[0036] Figure 2 An exploded view of one embodiment of the present invention is shown, and how the parts fit together to define the pre-filled syringe system 1. Other embodiments, orientations, and sequences of parts and assemblies are possible. Figure 2 As can be seen in the figure, the housing 9 accommodates the prefilled syringe 17, and then the needle shield 3 is installed on the housing 9 above the prefilled syringe 17. The prefilled syringe 17 can be obtained over the counter or is designed for use with the prefilled syringe system 1. This embodiment can adopt various disposable or non-disposable types. The prefilled syringe 17 may include a syringe barrel 18 with a syringe barrel flange 21, a needle 19, a needle tip 20, a plunger 22 with a plunger finger flange 23, and an optional needle cap 31. The plunger 22 is designed to be assembled into the syringe barrel 18. The syringe barrel 18 is designed to contain a solution of a pharmaceutical preparation or similar type.

[0037] Figure 3 4a and 4b. The needle shield 3 of this embodiment can be designed to include a first needle shield window 4a and a second needle shield window 4b ( Figure 3 4b is not shown in the figure). The needle shield windows 4a and 4b can be designed to be positioned opposite to each other. Other orientations and designs are also possible. As shown in the figure, the needle shield 3 can also be designed to include a first needle shield finger grip 6a and a second needle shield finger grip 6b. The first needle shield finger grip 6a and the second needle shield finger grip 6b can be designed and positioned opposite to each other and perpendicular to the first needle shield window 4a and the second needle shield window 4b. Various types and numbers of finger grips can be used. The finger grips 6a and 6b are shown in the form of ridges, with two pairs on each side (four pairs on each side or a total of 8 ridges). However, other designs are also possible. For example, a series of pits, notches or other protrusion types can be used instead of ridges to facilitate gripping of the components.

[0038] The needle shield 3 may be configured to further include a needle shield elongated hole 5 passing through the entire component. The needle shield elongated hole 5 may be designed to receive the housing 9 with or without the prefilled syringe 17 inserted. The needle shield 3 may include a single component or various different components assembled together.

[0039] refer to Figure 3 , the needle shield 3 of the illustrated embodiment includes a first locking tab 7a and a second locking tab 7b. The locking tabs 7a and 7b can be designed to face inward. The function of the locking tabs 7a and 7b will be further discussed below in conjunction with how they interact with the complementary locking features of the housing 9. The needle shield 3 can also be designed with various other design numbers and locking tabs. Figure 4A A plan view of the needle shield 3 is shown as seen from the first end 8a. Figure 4B A plan view of the needle shield 3 is shown from the opposite or second end 8b.

[0040] Figure 5 The housing 9 of this embodiment is shown. The housing 9 may be designed as a single component or as a series of components assembled together. Figure 5 The illustrated embodiment of the housing 9 includes a universal finger flange 10. The universal finger flange 10 can be designed in a variety of embodiment sizes and shapes. For the purposes of the present embodiment, the diameter of the universal finger flange 10 can range from about 5 mm to about 100 mm. The rounded and narrow tapered design allows the user to easily grasp, hold and orient the pre-filled syringe system 1 when the pre-filled syringe system 1 is assembled and used for injection, as will be discussed further below. Figure 5 The universal finger flange 10 is shown as being designed as part of the housing 9. However, it is envisioned that in certain embodiments, the universal finger flange 10 may be designed as a separate component with or without a tapered neck and mounted on the housing 9 in a variety of designs and orientations.

[0041] Reference again Figure 5The housing 9 may further include a housing elongated hole 11. The housing elongated hole 11 is adapted to receive a pre-filled syringe 17 when it is assembled and ready to be injected with medication (see for further details on how the components fit together). Figure 2 The housing elongate hole 11 extends through the entire housing 9, including the finger flange 10. The housing elongate hole 11 receives the pre-filled syringe 17 through a first end 12a near the finger flange 10.

[0042] The housing 9 may also include a first bevel 13a and a second bevel 13b at the second end 12b. The bevels 13a and 13b may be designed to engage the locking tabs 7a and 7b of the needle shield 3 when the components are assembled together. The first bevel 13a and the second bevel 13b may be designed to taper inwardly toward the central axis of the housing bore 11. Adjacent to the first bevel 13a and the second bevel 13b are first locking recesses 14a and second locking recesses 14b. The locking recesses 14a and 14b are designed to receive and engage the locking tabs 7a and 7b of the needle shield 3. In order for the locking tabs 7a and 7b to engage the locking recesses 14a and 14b, the needle shield 3 must first be mounted on the housing 9. Fig. 6A The housing 9 and needle shield 3 are shown in a partially assembled releasable locked injection position without the pre-filled syringe 17. It should be noted that both locking notches 14a and 14b are designed to be releasable. This allows the needle shield 3 to be subsequently adjusted to slide forward and engage the locking notches 16a and 16b, which will be discussed further below. Figure 6B The housing 9 and needle shield 3 are shown in a partially assembled protective position without the pre-filled syringe 17. The locking notches 16a and 16b may preferably be designed to be non-releasable. However, it is conceivable that in certain embodiments, they may be designed to be releasable if desired.

[0043] The first locking notch 16a and the second locking notch 16b are adjacent to and spaced from the locking notches 14a and 14b. After the needle shield 3 is mounted on the housing 9, it must be rotated into position so that the locking tabs 7a and 7b fall into place and engage the locking notches 14a and 14b. This click-feel engagement allows the user to know when the system is engaged and locked. The prefilled syringe system 1 is then in place for injection while holding the needle 19 and prefilled syringe 17 in a defined locked position and orientation. After the injection is complete, the needle shield 3 can then be released and removed from the housing 9 to cover only a portion of the housing 9 while protecting the needle 19 and engaging the first locking notch 16a and the second locking notch 16b.

[0044] The housing 9 may also include a first window housing 15a and a second window housing 15b. When the pre-filled syringe system 1 is assembled, the first and second window housings 15a and 15b are preferably aligned with the first and second needle window shields 4a and 4b. This alignment is preferred because it allows the subject 30 to observe the level and amount of the agent in the pre-filled syringe 17 at various desired times. For example, to determine whether the pre-filled syringe is filled before injection, whether a solution or agent is injected during injection, or whether it is empty after injection.

[0045] refer to Figure 2 , the prefilled syringe 17 includes a syringe barrel 18 having a syringe barrel flange 21, a needle 19 having a needle tip 20 (with an optional cap 31), and a plunger 22 having a plunger finger flange 23. The prefilled syringe 17 can be designed to contain a drug product. The drug product can include both small molecules and biologics of various formulations. For example, certain biologics that can be used with the present device can include biologics used to treat hemophilia, such as factor VII, factor VIII, factor IX, factor X, factor XI, insulin, And other similar small molecules, biological agents and combinations thereof known and used in the art. Typically, syringe barrel 18 can accommodate about 0.25 ml of agent to about 2.0 ml of agent. However, within the scope of this embodiment, various volumes can be used.

[0046] The prefilled syringe system 1 may also include a locking mechanism 33 for attaching the prefilled syringe 17 to the housing 9 and the prefilled syringe system 1. The locking mechanism 33 may include a syringe barrel flange 21, a mounting surface 32, a first locking surface 32a, and a second locking surface 32b (see FIG8 for details and assembly). It is conceivable that the locking mechanism 33 may include various components, organizations, and designs for attaching the prefilled syringe 17 to the housing 9 and the prefilled syringe system 1. In addition, it is conceivable that the locking mechanism 33 may include a portion of the prefilled syringe system 1 (as shown in the present embodiment), or include one or more separate components for attaching the prefilled syringe 17 to the housing 9 and the prefilled syringe system 1. In addition, the barrel flange 21 may be designed in different shapes or sizes for mounting and placing on the first and second locking surfaces 32a and 32b, respectively. The first locking surface 32a and the second locking surface 32b may also be designed as tabs or similar types of structures.

[0047] The assembly of the embodiment can be started by placing the drug preparation into the syringe barrel 18 of the prefilled syringe 17. The plunger 22 is then inserted into the syringe barrel 18 behind the drug preparation so that it contacts or almost contacts the preparation and removes any bubbles from the needle tip 20. An optional cap 31 may be included in the assembly and remains mounted on the needle tip 19 to prevent accidental needle sticks. However, the optional cap 31 must be removed before injecting the subject 30. The plunger 22 is then maintained in the loaded pre-injection position. The prefilled syringe 17 with the preparation is then inserted into the housing hole 11 through the end (second end 12a) with the universal finger flange 10. The prefilled syringe 17 is slid into the housing hole 11 until the syringe barrel 18 and the syringe barrel flange 21 are placed against the mounting surface 32 of the universal finger flange 10 (see Figures 7 and 8). The mounting surface 32 can be designed to be grooved, serrated, tapered, concave or other similar types of designs or shapes to engage the syringe barrel 18 and the syringe barrel flange 21 of the prefilled syringe 17.

[0048] The prefilled syringe 17 should preferably fit tightly enough by friction so that it does not disengage or fall out of the housing 9. In certain embodiments (as shown in FIGS. 7 and 8 ), a locking mechanism 33 may be used to attach the prefilled syringe 17 to the housing 9 and the prefilled syringe system 1. For example, after the prefilled syringe 17 is assembled, installed in the housing 9, and the prefilled syringe flange 21 is seated on the chevron surface 32 of the universal finger flange, the locking mechanism 33 may be locked. For example, the syringe barrel flange 21 may be rotated to engage the first locking surface 32a and the second locking surface 32b, thereby securely locking and attaching the prefilled syringe 17 to the housing 9 and the prefilled syringe system 1 (see FIG. 1 ). Figure 8B and 8C ). It is conceivable that the locking mechanism 33 can be designed into various releasable and non-releasable locking designs and forms.

[0049] During this process, the plunger 22 of the prefilled syringe 17 remains in the loaded pre-injection position. Next, the needle shield 3 is installed on the housing 9 by sliding the needle shield 3 on the housing using the needle shield hole 5. The first and second locking tabs 7a and 7b of the needle shield 3 slide along the first and second ramps 13a and 13b until they contact the housing 9. The needle shield 3 is installed in such an orientation that the end with the first and second finger grips 6a and 6b is installed on the housing 9 first. Once the needle shield 3 has been installed on the housing 9, it is then rotated so that the first and second tabs 7a and 7b fall into the first and second locking recesses 14a and 14b. In this orientation, the first and second needle shield windows 4a and 4b are aligned with the first and second housing windows 15a and 15b so that the syringe barrel 18 of the prefilled syringe 17 with the preparation can be viewed. The prefilled syringe system 1 is now in the locked injection mode and is ready for use. At this point, the user only needs to remove the needle cap 31 from the prefilled syringe needle tip 20 and perform an injection. Fig. 7A and 7B A cross-sectional view of the pre-filled syringe system 1 and the pre-filled syringe 17 in the locked and protected position is shown, and how the needle tip 20 can extend from the needle shield 3 and the pre-filled syringe system 1 to a defined length (see Fig. 7A ) or protected by needle shield 3 (see Figure 7B ).

[0050] Now that the components and their assembly have been described, a method of using the pre-filled syringe system 1 will now be described in order.

[0051] FIG9 illustrates the injection method of this embodiment. As previously described, the prefilled syringe system 1 is assembled with a prefilled syringe 17 having a drug formulation. Once the drug is loaded, the prefilled syringe plunger 22 is also in an extended and loaded position. Once the needle shield 3 has been positioned on the housing 9 and placed in a locked position with the extended needle tip 20, the device is ready for use. The extent of the protrusion of the needle tip 20 can depend on the length of the needle 19 and the size of the needle shield 3. The extended length can be any value from 2 mm to 30 mm (measured from the edge of the needle shield 3), or preferably any range from about 4 mm to about 8 mm, depending on the desired depth of injection into the subject.

[0052] The subject holds the entire pre-filled syringe system 1 in one hand, with the finger around the universal finger flange 10 ( Fig.9A ). The needle tip 20 and a portion of the needle 19 are then inserted into the subject 30. Once the needle 19 is inserted, it continues until the needle shield 3 contacts the subject 30 and cannot penetrate deeper into the subject's skin ( Fig. 9B). Next, the plunger 22 of the prefilled syringe 17 is depressed and the contents of the formulation are injected into the subject 30. In this context, the drug is delivered to the subject 30 at a desired location and depth. After the injection has been completed, the prefilled syringe system 1 and the prefilled syringe 17 are then removed from the subject 30 (see Fig. 9C ). At this point, the needle 19 and the needle tip 20 are still extending from the needle shield 3 in the locked position (as previously described, the releasable first and second locking tabs 7a, 7b are positioned in the first and second locking recesses 14a, 14b). Pressure is then applied to the side of the needle shield 3 to release the first and second locking tabs 7a, 7b from the first and second locking recesses 14a, 14b, so that the needle shield 3 can slide forward on the housing 9, so that the first and second locking tabs 7a, 7b of the needle shield 3 engage the first and second locking recesses 16a, 16b of the housing 9 (see FIG. 1 ). Fig.9D ). As previously described, the first and second locking recesses 14a and 14b are preferably designed for releasable movement of the needle shield 3, while the first and second locking recesses 16a and 16b are not designed for releasable movement of the needle shield 3. In this second position, the needle shield 3 now fully protects and encloses the needle 19 and needle tip 20, so they no longer extend outside the prefilled syringe system 1 to potentially injure the subject 30. The prefilled syringe system 1 and the prefilled syringe 17 can then be safely disposed of without risk of injury to the subject 30 or other persons.

Claims

1. A prefilled syringe system (1) for controlled depth injection into a subject (30), comprising: a pre-filled syringe (17) having a needle tip (20) and a plunger (22) for injecting the contents of the pre-filled syringe (17); A housing (9) for accommodating the prefilled syringe (17) and the needle tip (20) at a defined injection depth, the housing (9) having a first end (12a) proximal to the finger flange (10) and a second end (12b); and a needle shield (3) mounted on the housing (9) for releasable movement from a locked injection position to a protection position, wherein after the needle shield (3) is moved to the locked injection position and the needle tip (20) extends out of the needle shield (3) and the prefilled syringe system (1), the needle (19) can be inserted into the subject at a defined injection depth, It is characterized in that The needle shield (3) has a first locking tab (7a) facing inwards and a second locking tab (7b) facing inwards; The housing (9) comprises on its outer surface: a first bevel (13a) and a second bevel (13b), wherein the first bevel (13a) and the second bevel (13b) are adapted to engage the first locking tab (7a) and the second locking tab (7b) to mount the needle shield (3) on the housing (9); a first locking recess (14a) and a second locking recess (14b) adjacent to and angularly offset from the first ramp (13a) and the second ramp (13b), the first locking recess (14a) and the second locking recess (14b) being designed to receive and releasably engage the first locking tab (7a) and the second locking tab (7b) when the needle shield (3) is installed and rotated to the injection position; a first additional locking recess (16a) and a second additional locking recess (16b), wherein the first additional locking recess (16a) and the second additional locking recess (16b) are designed to receive and engage the first locking tab (7a) and the second locking tab (7b) when the needle shield (3) is moved to the protection position, Wherein, the first additional locking recess (16a) and the second additional locking recess (16b) are adjacent to and separated from the first locking recess (14a) and the second locking recess (14b) in the direction of the second end (12b), and are aligned with the first locking recess (14a) and the second locking recess (14b).

2. The prefilled syringe system (1) according to claim 1, wherein: The first additional locking recess (16a) and the second additional locking recess (16b) are designed to non-releasably receive and engage the first locking tab (7a) and the second locking tab (7b).

3. The prefilled syringe system (1) according to claim 1 or 2, wherein: The first locking tab (7a) and the second locking tab (7b) are located on opposite sides of the needle shield (3), and the first locking recess (14a) and the second locking recess (14b) are located on opposite sides of the housing (9).

4. The prefilled syringe system (1) according to claim 1 or 2, wherein: The needle tip (20) extends 4 mm to 8 mm from the needle shield (3) and pre-filled syringe system (1).

5. The prefilled syringe system (1) according to claim 1 or 2, wherein: The housing (9) further comprises a universal finger flange (10), wherein the universal finger flange (10) is circular and has a tapered neck.

6. The prefilled syringe system (1) according to claim 1 or 2, wherein: The housing (9) comprises at least one window (15a, 15b) for viewing the contents of the pre-filled syringe (17).

7. The prefilled syringe system (1) according to claim 1 or 2, wherein: The needle shield (3) comprises one or more finger grips (6a, 6b).

8. The prefilled syringe system (1) according to claim 1 or 2, wherein: The needle shield (3) comprises at least one needle shield window (4a, 4b) for observing the injected contents in the pre-filled syringe (17).

9. The prefilled syringe system (1) according to claim 1 or 2, wherein: The housing (9) comprises a single component and / or the needle shield (3) comprises a single component.

10. The pre-filled syringe system (1) according to claim 1 or 2, further comprising a locking mechanism (33) for attaching the pre-filled syringe (17) to the housing (9) and the pre-filled syringe system (1).

11. A system for controlled injection depth in a subject (30) when attached to a pre-filled syringe (17), comprising: (a) a housing (9) for accommodating the prefilled syringe (17), the housing (9) having a first end (12a) proximate to the finger flange (10) and a second end (12b); and (b) a needle shield (3) mounted on the housing (9) for releasable movement from a locked injection position to a protection position, It is characterized in that The needle shield (3) has a first locking tab (7a) facing inwards and a second locking tab (7b) facing inwards; The housing (9) comprises on its outer surface: a first bevel (13a) and a second bevel (13b), wherein the first bevel (13a) and the second bevel (13b) are adapted to engage the first locking tab (7a) and the second locking tab (7b) to mount the needle shield (3) on the housing (9); a first locking recess (14a) and a second locking recess (14b) adjacent to and angularly offset from the first ramp (13a) and the second ramp (13b), the first locking recess (14a) and the second locking recess (14b) being designed to receive and releasably engage the first locking tab (7a) and the second locking tab (7b) when the needle shield (3) is installed and rotated to the injection position; a first additional locking recess (16a) and a second additional locking recess (16b), wherein the first additional locking recess (16a) and the second additional locking recess (16b) are designed to receive and engage the first locking tab (7a) and the second locking tab (7b) when the needle shield (3) is moved to the protection position, Wherein, the first additional locking recess (16a) and the second additional locking recess (16b) are adjacent to and separated from the first locking recess (14a) and the second locking recess (14b) in the direction of the second end (12b), and are aligned with the first locking recess (14a) and the second locking recess (14b).

12. The system according to claim 11, wherein: The first additional locking recess (16a) and the second additional locking recess (16b) are designed to non-releasably receive and engage the first locking tab (7a) and the second locking tab (7b).

13. The system according to claim 11 or 12, wherein: The first locking tab (7a) and the second locking tab (7b) are located on opposite sides of the needle shield (3), and the first locking recess (14a) and the second locking recess (14b) are located on opposite sides of the housing (9).

14. The system according to claim 11 or 12, wherein: The housing (9) further comprises a universal finger flange (10), wherein the universal finger flange (10) is circular and has a tapered neck.

15. The system according to claim 11 or 12, wherein: The housing (9) comprises a single component and / or the needle shield (3) comprises a single component.

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