Safety assembly for mounting on syringe

Abstract

The assembly comprises: a syringe barrel (12) having a needle (11); a tubular body (2) defining a housing; the cartridge (12) extends at least partially within the housing; a safety shield (3) for the needle (11), the safety shield being longitudinally movable relative to the tubular body (2) between a retracted position and an activated position; a spring (4) which urges the safety shield (3) towards the activated position; a first locking mechanism (31) for locking the safety shield (3) in the retracted position, where the first locking mechanism (31) is manually releasable by a user in order to bring the safety shield (3) into the activated position, where the safety shield (3) is rotatable within the body (2), where the first locking mechanism (31) is releasable manually by the user in order to bring the safety shield (3) into the activated position. The body (2) has a distal portion (302) axially projecting from the distal portion (202) of the body (2) for gripping the safety shield (3); the first locking mechanism (31) is configured to release the safety shield (3) when the safety shield (3) is rotated from a first angular position to a second angular position.

Description

Technical Field

[0001] The present invention relates to a needle protection system, and more particularly, to a syringe assembly for use in drug delivery, the syringe assembly including a shield for enclosing the syringe needle after drug delivery is completed. Background Art

[0002] In the present application, the distal end of a component or device is understood to mean the end furthest from the hand of the user, and the proximal end is understood to mean the end closest to the hand of the user. Similarly, in the present application, the "distal direction" is understood to mean the injection direction relative to the safety device or syringe of the present invention, and the "proximal direction" is understood to mean the direction opposite to the injection direction, that is, the direction towards the hand of the user.

[0003] Prefillable syringes, or prefilled syringes, typically include a hollow tubular body or barrel, forming a container for a medical product. The tubular body includes a distal end in the form of a longitudinal tip that defines an axial passage through which the medical product is expelled from the container. The distal end is equipped with a needle for injecting the medical product into an injection site.

[0004] Protecting patients and users from any risk of needle stick injuries is crucial, especially between the time an injection is completed and the moment the drug delivery device is discarded.

[0005] The needle guard may be of the so called active type, where the guard is activated by the user after the injection. An example of a guard system is the Becton Dickinson Preventis TM Needle guard system, this system realizes the one-hand controlled activation for automatic needle guard.After injection, for example disclosed by EP1397170, further pressure on the piston rod triggers the guard. Summary of the Invention

[0006] This has proven satisfactory, but it would be desirable for the activation force to be completely independent of the injection movement and to be adjustable for usability purposes, such as allowing protection even after a partial injection (which may be necessary in some cases due to the patient's age or weight).

[0007] According to one aspect, the present invention relates to a syringe assembly for use in drug delivery, comprising:

[0008] - a syringe barrel having a needle at a distal end;

[0009] - a tubular body defining a housing, said barrel extending at least partially within said housing;

[0010] - a safety shield for the needle, the safety shield being longitudinally movable relative to the tubular body between a retracted position and an activated position;

[0011] - a spring urging the safety shield toward the activated position;

[0012] - a first locking mechanism for locking the safety shield in the retracted position, wherein the first locking mechanism is manually releasable by a user in order to allow the safety shield to reach the activated position.

[0013] - wherein the safety shield is rotatable within the body and has a distal portion projecting axially from a distal portion of the body for gripping the safety shield;

[0014] - The first locking mechanism is configured to release the safety shield when the safety shield (3) is rotated from the first angular position to the second angular position.

[0015] In some embodiments, the syringe assembly includes a second locking mechanism for permanently and irreversibly locking the safety shield in the activated position after the first locking mechanism is released.

[0016] In some embodiments, the second locking mechanism is configured to receive and then retain a proximal portion of the safety shield.

[0017] In some embodiments, the second locking mechanism includes a first retaining feature on an exterior face of the proximal portion of the safety shield, the first retaining feature being forcibly deformed when the safety shield moves from the retracted position toward the activated position.

[0018] In some embodiments, the second locking mechanism further includes a second retaining feature on an interior face of the distal portion of the body, the second retaining feature configured to interact with the first retaining feature when the safety shield moves from the retracted position toward the activated position.

[0019] In some embodiments, the distal portion of the safety shield exhibits textured features to enhance grip.

[0020] In some embodiments, the needle is covered by the safety shield in the activated position and the needle is not covered by the safety shield in the retracted position.

[0021] In some embodiments, the first locking mechanism includes complementary first and second mating surfaces on the safety shield and the body, respectively.

[0022] In some embodiments, the first mating surface is also part of the first retention feature.

[0023] In some embodiments, the syringe assembly comprises a prefilled syringe comprising the barrel, the needle, the stopper, and the plunger rod.

[0024] According to another aspect, the present invention relates to a shield system for a syringe for use in drug delivery, the syringe comprising a barrel and a needle at the distal end of the barrel, the shield system comprising:

[0025] - a tubular body defining a housing, said barrel extending at least partially within said housing;

[0026] - a safety shield for the needle, the safety shield being longitudinally movable relative to the tubular body between a retracted position and an activated position;

[0027] - a spring urging the safety shield toward the activated position;

[0028] a first locking mechanism for locking the safety shield in the retracted position, wherein the first locking mechanism is manually releasable by a user in order to allow the safety shield to reach the activated position;

[0029] - wherein the safety shield is rotatable within the body and has a distal portion projecting axially from a distal portion of the body for gripping the safety shield;

[0030] - The first locking mechanism is configured to release the safety shield when the safety shield is rotated from the first angular position to the second angular position.

[0031] According to another aspect, the present invention relates to a method for operating a syringe assembly or protection system, comprising the steps of rotating a safety shield from a first angular position to a second angular position to trigger release of a first locking mechanism such that a spring moves the safety shield from a retracted position toward an activated position. BRIEF DESCRIPTION OF THE DRAWINGS

[0032] The present invention and its advantages will become more apparent from the following detailed description made with reference to the accompanying drawings, which are as follows:

[0033] Figure 1 is a top perspective view of an embodiment of a syringe assembly according to the present invention with the needle safety shield in a retracted position;

[0034] Figure 2 yes Figure 1 a top perspective view of the syringe assembly shown with the needle safety shield in the activated position;

[0035] Figure 3 is a view of the locking mechanism of the syringe assembly (in Figure 1 );

[0036] Figure 4 is a view of the locking mechanism of the syringe assembly (in Figure 2 );

[0037] Figure 5 yes Figure 1 Exploded view of the syringe assembly shown. DETAILED DESCRIPTION

[0038] The different features of an embodiment may be combined and used with other embodiments, so long as the combined parts do not conflict with or interfere with the operation of the device and components. The present invention is not limited in its application to the construction details and component arrangements described in the following description or shown in the accompanying drawings. The embodiments herein can be modified, practiced, or implemented in various ways. The wording and terminology used herein are for descriptive purposes and should not be construed as restrictive. The use of "include," "comprise," or "have" and their variations herein encompass the items listed thereafter and their equivalents, as well as additional items. Unless otherwise limited, the terms "connect," "couple," and "mount" and their variations are used broadly herein and encompass both direct and indirect connections, couplings, and mountings. Furthermore, the terms "connect," "couple," and their variations are not limited to physical or mechanical connections or couplings. Furthermore, terms such as distal, proximal, upper, lower, bottom, and top are relative and are intended to aid description rather than limitation. The embodiments are not intended to be mutually exclusive, and therefore, features of one embodiment may be combined with other embodiments as long as they do not contradict each other. Those skilled in the art will understand that terms of degree such as "substantially," "approximately," and "approximately" refer to a reasonable range around (including) a given value as well as a range outside of a given value, such as general tolerances associated with the manufacture, assembly, and use of embodiments. When referring to a structure or feature, the term "substantially" includes most or all of the features present in the structure.

[0039] Figure 1 and Figure 2 Perspective views of the syringe assembly 10 are shown in a first state and a second state, respectively, according to an embodiment of the present invention.

[0040] The syringe assembly 10 is for use in drug delivery (particularly subcutaneous injection) and preferably comprises a complete syringe 1 (particularly a prefillable syringe, which typically contains a single dose of drug, such as 0.3 ml, 0.5 ml or 1.0 ml), which is connected to a tubular body 2 that performs a shielding function. The syringe typically comprises: a barrel 12 having a proximal end 121 and a distal end 122 relative to the longitudinal axis; a needle 11 (or other puncture or connection element, such as a cannula), which is fixed to the distal end of the barrel 12; a stopper 13, which is slidably positioned within the barrel 12; and a plunger rod 14, which is engageable with the stopper. A removable needle cap 15 can be provided on the needle 11. The barrel 12 defines an internal fluid chamber. Forward movement of the plunger rod 14 (along the longitudinal axis) causes the stopper 13 to move from the proximal end 121 towards the distal end 122 (compare Figure 1 and Figure 2 ) moves, thereby expelling fluid from the barrel 12 through the needle 11. Rearward movement of the plunger rod 14 in the proximal direction draws fluid into the barrel 12. Glass barrels are commonly used for prefillable or prefilled syringes, but plastic barrels are also well known.

[0041] The syringe barrel 12 is coupled to the tubular body 2. The tubular body 2 is preferably an elongated, generally cylindrical member, particularly made of plastic (preferably a semi-rigid plastic material such as polypropylene), defining a generally cylindrical housing that advantageously shares a common longitudinal axis with the barrel 12. The tubular body 2 has proximal and distal open ends, providing access to the housing. A finger flange 20 extends radially outward from the tubular body 2 near its proximal open end. The finger flange 20 and the tubular body 2 are designed to facilitate manipulation during injection, allowing for single-handed administration. The syringe assembly 10 also includes a safety shield 3 for the needle 11, which is movable longitudinally relative to the tubular body 2 and, thereby, relative to the barrel 12, between a retracted position and an activated position, and a spring 4 configured to move the shield 3. Preferably, the shield 3 is movable along the same longitudinal axis as the barrel 12 and / or the tubular body 2. Like the tubular body 2, the shield 3 is preferably an elongated, generally cylindrical piece, particularly made of plastic, for example a semi-rigid plastic material such as polypropylene. In some embodiments, the spring 4 can be a metal coil spring, although other energy release elements, such as deformable blades, are also contemplated. In some embodiments, the shield 3 has a length at least as long as the needle 11.

[0042] The syringe barrel 12 extends at least partially (and preferably substantially completely) within the housing of the tubular body 2. The barrel 12 can be slidably engaged within the tubular body 2, and thus the syringe barrel 12 can include a radially outwardly extending flange for coupling an existing prefillable or prefilled syringe to the tubular body 2. In other embodiments, the tubular body 2 can be permanently fixed to the barrel 12.

[0043] In any case, the needle safety shield 3 and spring 4 can be placed within the tubular body 2. An annular gap is preferably maintained within the housing between the tubular body 2 and the barrel 12 for accommodating the shield 3 and spring 4. Thus, the safety shield 3 and spring 4 are preferably configured and sized to be positioned within the tubular body 2 and assembled to the barrel 12.

[0044] In some embodiments, the needle 11 is covered by the safety shield 3 in the activated position, and in the retracted position the needle 11 is not covered by the safety shield 3. "Covering" the needle 11 means enclosing the needle end so that it is not exposed, thereby preventing any risk of injury.

[0045] In other words, in the retracted position, the shield 3 is partially (and preferably completely) engaged within the housing of the tubular body 2, so that the needle 11 is exposed for use, and in the activated position (or "extended" position), the shield 3 protrudes axially from the tubular body 2 toward the distal end, thereby covering the needle 11.

[0046] The "first state" refers to the state in which the shield 3 is retracted (see Figure 1 ) of the present syringe assembly, and the "second state" refers to the state in which the shield 3 is in the activated state (see Figure 2 ) of the status of this syringe assembly.

[0047] A spring 4 urges the safety shield 3 toward the activated position. To this end, the tubular body 2 may include an end shoulder (near its proximal open end), and in the retracted position, the spring 4 is compressed between the shield 3 and the end shoulder. Thus, the spring 4 pushes the shield 3 in the longitudinal direction: "relaxation" of the spring 4 results in longitudinal movement of its distal tip, and subsequently of the shield 3, extending proximally from the distal end of the tubular body 2 and then reaching the activated position. In other embodiments (not shown), the proximal end of the spring 4 may be directly fixed to the tubular body 2.

[0048] In some embodiments, the syringe assembly 10 includes a first locking mechanism 31 for locking the safety shield 3 in the retracted position. In fact, without the first locking mechanism 31, the shield 3 would not be retained in the retracted position due to the urging action of the spring 4. In other words, the first locking mechanism 31 secures the shield 3 and / or the spring 4 in place, thereby preventing the spring 4 from longitudinally moving the shield 3 toward the activated position. The force of the spring 4 alone is insufficient to disengage the shield 3.

[0049] However, the first locking mechanism 31 can be manually releasable by the user to allow the safety shield 3 to reach the activated position. In other words, the user can trigger the deactivation of the first locking mechanism 31 through an action (see below), causing it to stop restricting the movement of the shield 3 and / or spring 4. Thanks to the spring 4, the shield 3 switches from the retracted position to the activated position. We will refer to the manual release of the first locking mechanism 31 as "activation of the shield," and thus the word "activated" refers to the state of the shield 3 when it is extended.

[0050] The shield 3 is naturally held in the activated position by the spring 4, but sufficient force can move the safety shield 3 back to the retracted position, thereby exposing the needle 11. In some embodiments, the present syringe assembly may include a second locking mechanism 32 for locking the safety shield 3 in the activated position after the first locking mechanism 31 is released. Unlike the first locking mechanism 31, the second locking mechanism 32 cannot be manually released, even if the user accidentally does so: the needle 11 cannot become exposed again, thereby ensuring the safety of the user and the patient.

[0051] In summary, the safety shield 3 is initially held in the retracted position by the first locking mechanism 31 , then, after drug delivery is complete, the user releases it and the safety shield 3 moves longitudinally until engaging the second locking mechanism 32 , preventing it from switching back to the restricted position.

[0052] The present assembly 10 comprises a tubular body 2, a shield 3 and locking mechanisms 31, 32 which are completely independent of the injection movement. Figure 2 This indicates that the plunger rod 14 is fully pushed to the bottom, ie the drug has been fully delivered, but in reality, the shield 3 can be deployed regardless of the position of the plunger rod 14 .

[0053] In particular, if Figure 1 and Figure 2 As shown:

[0054] The safety shield 3 is rotatable within the body 2 (which is typically the case if the shield 3 is also tubular) and has a distal portion 302 that protrudes axially from the distal portion 202 of the body 2 (in some embodiments, at least 1 cm) for gripping the safety shield 3. More precisely, while the majority of the shield 3 is located within the body 2 and is inaccessible to the user, the distal portion 302 extends beyond the body 2 so that the user can grip it, in particular for manually rotating the shield 3. Preferably, the distal portion 302 of the safety shield 3 exhibits textured features (such as, for example, Figure 1 and Figure 2 As shown, the teardrop shape) is used to increase grip (ie, attachment), thereby making it easier for users to grasp and rotate.

[0055] - The first locking mechanism 31 is configured to release the safety shield 3 when the safety shield 3 is rotated from the first angular position to the second angular position. It should be understood that the first locking mechanism 31 does not prevent the shield 3 from rotating, but only from axial translation.

[0056] The first angular position can be defined arbitrarily, what is important is that there is at least one angular position (called the first angular position) at which the safety shield 3 is locked in the retracted position, and at least one position (called the second angular position) different from the first angular position at which the safety shield 3 is released.

[0057] The first angular position is a “locked” angular position and the second angular position is an “unlocked” angular position.

[0058] The rotation of the shield 3 (due to the distal portion 302) allows movement from a first angular position to a second angular position, hence the term "rotation trigger". The relative difference between the first angular position and the second angular position is, for example, 90°, but any angular value may be used. In some embodiments, there may be multiple first angular positions and / or second angular positions around the shield 3, for example:

[0059] - the first angular position is 0°;

[0060] - the second angular position is 90°;

[0061] - another first angular position is 180°;

[0062] - Another second angular position is 270°.

[0063] The combination of the rotatable shield 3 and the body 2 allows for a simple and very reliable locking mechanism.

[0064] In some embodiments, it comprises complementary mating surfaces 311, 312 on the safety shield 3 and the body 2, see Figure 3. More precisely, the outer surface of the shield 3 (typically located at the proximal portion 301 of the shield 3) includes a first mating surface 311 (such as a tab), and the inner surface of the body 2 (typically located at the proximal portion 201 of the body 2) includes a complementary second mating surface 312 (such as another tab). When the shield 3 is in the first angular position, the first and second mating surfaces 311, 312 face each other (and abut) thereby preventing the shield 3 from translating toward the activated position. Each mating surface 311, 312 has only a limited azimuthal span, which means that after the shield 3 is fully rotated (up to the second angular position), they no longer face each other, thereby triggering the release of the shield 3. In some embodiments, there may be several first mating surfaces 311 and several mating surfaces 312, for example two pairs, which are diametrically opposed, see Figure 3 and Figure 4 .

[0065] In another embodiment, the shield 3 may include a longitudinal slot and the body 3 may include a radial pin that engages the longitudinal slot (protruding from the inner surface of the body 2, toward the center of the syringe assembly 1), and the first locking mechanism 31 is then configured to retain the radial pin at a proximal portion of the longitudinal slot when the shield 3 is in a first angular position (e.g., a bayonet mount with a notch).

[0066] Similarly, there is a second locking mechanism 32 that is configured to receive and then retain the proximal portion 301 of the safety shield 3 .

[0067] In some embodiments, the second locking mechanism 32 may be a semi-flexible fastener, preferably having a first retaining feature 321 on the outer face of the proximal portion 301 of the safety shield 3, which is forcibly deformed when the safety shield 3 moves from the retracted position toward the activated position. The first retaining feature 321 may also include a first mating surface 311, such as a tab, see Figure 4 In other words, in this case the first mating surface is part of both the first and second locking mechanism 31 , 32. This allows for an overall simple and reliable architecture.

[0068] In the illustrated embodiment, the proximal portion 301 of the shield is divided (by longitudinal cuts) into a plurality of flexible "strips" with (one or more) first mating surfaces 311 located at the ends of the strips. The combination of the strips and the first mating surfaces 311 forms the first retention feature 321. Thus, when the safety shield 3 is moved from the retracted position toward the activated position, each strip presenting a first mating surface 311 is forcibly deflected.

[0069] In some embodiments, the second locking mechanism 32 may include a second retaining feature 322 located on the interior face of the distal portion 202 of the body 2, the second retaining feature being configured to interact with the first retaining feature 321 when the safety shield 3 moves from the retracted position toward the activated position, so as to permanently and irreversibly lock the safety shield 3 in the activated position after the first locking mechanism 31 is released. "Interact" or "mate" means that the first and second retaining features 321, 322 are also complementary and can interlock when they come into contact. In other words, during movement of the shield 3, the first retaining feature 321 is forcibly deflected until it securely engages with the second retaining feature 322, and because they are configured so that disengagement is impossible, a permanent lock is achieved.

[0070] exist Figure 3 and Figure 4 In the embodiment of the present invention, the second retaining feature 322 is a protrusion, such as a "teeth," extending from the inner surface of the distal portion 202 of the body 2 and may be V-shaped (i.e., extending not longitudinally but at a slight angle). Under the force of the spring 4, the strip of the first retaining feature 321 is deflected as the first mating surface 311 (tab) passes over these teeth, and the strip then resumes its position. At this stage, the first mating surface 311 abuts the teeth of the second retaining feature 322 (this is the "interaction" of the second retaining feature 322 with the first retaining feature 321), and the strip cannot be forcibly deformed again by an axial force in the opposite direction.

[0071] The first locking mechanism 31 can be manually released by the user (by rotating the shield 3), and / or the second locking mechanism 32 cannot be manually released by the user. In fact, in the activated position, either the rotation of the shield 3 has no effect, since it does not have any effect on the second locking mechanism 32, or the rotation of the shield 3 becomes impossible; Figure 4 This is the case with the embodiment of , where the teeth of the second retaining feature 322 extend onto both the top and sides of the first mating surface 311 of the first retaining feature 321, thereby preventing any movement of the shield 3 when in the activated position.

[0072] In theory, it is still possible to manually deflect the strip by pressing it, allowing it to pass through the teeth again. However, the shield 3 is located inside the body 2, and its proximal portion 301 remains hidden even in the activated state. Therefore, this manipulation is almost impossible for the user: the user cannot access the first retaining feature 321 and the second retaining feature 322, so the second locking mechanism 32 is not manually releasable by the user and, once locked, is almost irreversible.

Claims

1. A syringe assembly for use in drug delivery, comprising: - a syringe barrel (12) having a needle (11) at its distal end (122); - a tubular body (2) defining a housing within which the cartridge (12) extends at least partially; - a safety shield (3) for the needle (11), the safety shield being longitudinally movable relative to the tubular body (2) between a retracted position and an activated position; - a spring (4) which urges the safety shield (3) towards the activated position; a first locking mechanism (31) for locking the safety shield (3) in the retracted position, wherein the first locking mechanism (31) can be manually released by a user in order to allow the safety shield (3) to reach the activated position, - wherein the safety shield (3) is rotatable within the body (2) and has a distal portion (302) protruding axially from the distal portion (202) of the body (2) for gripping the safety shield (3); - the first locking mechanism (31) is configured to release the safety shield (3) when the safety shield (3) is rotated from a first angular position to a second angular position; - a second locking mechanism (32) for permanently and irreversibly locking the safety shield (3) in the activated position after the first locking mechanism (31) has been released, The second locking mechanism (32) is configured to receive and then retain the proximal portion (301) of the safety shield (3), the second locking mechanism (32) comprising a first retaining feature (321) located on the outer surface of the proximal portion (301) of the safety shield (3), the first retaining feature being forcibly deformed when the safety shield (3) moves from the retracted position toward the activated position; and a second retaining feature (322) located on the inner surface of the distal portion (202) of the body (2), the second retaining feature being configured to interact with the first retaining feature (321) when the safety shield (3) moves from the retracted position toward the activated position.

2. The syringe assembly of any one of claims 1, wherein the distal portion (302) of the safety shield (3) presents textured features to enhance grip.

3. The syringe assembly of any one of claims 1 to 2, wherein the needle (11) is covered by the safety shield (3) in the activated position, and the needle (11) is not covered by the safety shield (3) in the retracted position.

4. The syringe assembly of any one of claims 1 to 3, wherein the first locking mechanism (31) comprises complementary first and second mating surfaces (311, 312) located on the safety shield (3) and the body (2), respectively.

5. The syringe assembly of claim 4, wherein the first mating surface (311) is also part of the first retaining feature (321).

6. The syringe assembly according to any one of claims 1 to 5, comprising a prefilled syringe (1) comprising the barrel (12), the needle (11), the stopper and the plunger rod (14).

7. A protection system for a syringe (1) for use in drug delivery, the syringe comprising a barrel (12) and a needle (11) located at a distal end (122) of the barrel (12), the protection system comprising: - a tubular body (2) defining a housing within which the cartridge (12) extends at least partially; - a safety shield (3) for the needle (11), the safety shield being longitudinally movable relative to the tubular body (2) between a retracted position and an activated position; - a spring (4) which urges the safety shield (3) towards the activated position; a first locking mechanism (31) for locking the safety shield (3) in the retracted position, wherein the first locking mechanism (31) can be manually released by a user in order to allow the safety shield (3) to reach the activated position; - wherein the safety shield (3) is rotatable within the body (2) and has a distal portion (302) protruding axially from the distal portion (202) of the body (2) for gripping the safety shield (3); - the first locking mechanism (31) is configured to release the safety shield (3) when the safety shield (3) is rotated from a first angular position to a second angular position, - a second locking mechanism (32) for permanently and irreversibly locking the safety shield (3) in the activated position after the first locking mechanism (31) has been released, The second locking mechanism (32) is configured to receive and then retain the proximal portion (301) of the safety shield (3), -The second locking mechanism (32) includes a first retaining feature (321) located on the outer surface of the proximal portion (301) of the safety shield (3), which is forcibly deformed when the safety shield (3) moves from the retracted position toward the activated position; and a second retaining feature (322) located on the inner surface of the distal portion (202) of the body (2), which is configured to interact with the first retaining feature (321) when the safety shield (3) moves from the retracted position toward the activated position.

8. A method for operating a syringe assembly according to any one of claims 1 to 6 or a protection system according to claim 7, comprising the steps of: Rotating the safety shield (3) from the first angular position to the second angular position triggers the release of the first locking mechanism (31), causing the spring (4) to move the safety shield (3) from the retracted position toward the activated position.

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