Safety assembly for attachment to syringe

Abstract

The assembly comprises a syringe barrel (12) having a needle (11) at its distal end (122), a tubular body (2) defining a housing, the barrel (12) extending at least partially into the housing, a safety shield (3) for the needle (11) longitudinally movable relative to the tubular body (2) between a retracted position and an activated position, a spring (4) biasing the safety shield (3) toward the activated position, and a first locking mechanism (31) for locking the safety shield (3) in the retracted position, the safety shield (3) being rotatable within the body (2), the first locking mechanism (31) having a distal portion (302) axially protruding from the distal portion (202) of the body (2) for grasping the safety shield (3), the first locking mechanism (31) 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 shield system, and more particularly to a syringe assembly used for drug delivery that includes a shield for covering the syringe needle after drug delivery is complete. [Background technology]

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

[0003] A prefillable or pre-filled syringe typically comprises a hollow tubular body or barrel forming a reservoir for the medical product, the tubular body having a distal end in the form of a longitudinal tip defining an axial passageway through which the medical product is discharged from the reservoir, and a needle fitted at the distal end for injecting the medical product into an injection site.

[0004] In particular, it is very important to protect the patient or user from the risk of needlestick injury between the time the injection is completed and the time the drug delivery device is disposed of.

[0005] Needle shielding devices can be so-called active, where the user activates the shielding device after injection. An example of a shielding system is the Becton Dickinson Preventis®, which allows for one-handed controlled activation to automatically shield the needle. After injection, additional pressure on the piston rod triggers the shielding, as disclosed, for example, in EP 1 397 170 A1. Summary of the Invention [Problem to be solved by the invention]

[0006] While this is satisfactory, it would be desirable if the activation force were completely independent of the injection movement and could be adjusted for ease of use, for example to allow shielding even after partial injection (which may be necessary due to the patient's age or weight). [Means for solving the problem]

[0007] According to one aspect, the present invention relates to a syringe assembly for use in drug delivery, comprising: a syringe barrel having a needle at a distal end of the barrel; a tubular body defining a housing, the barrel extending at least partially within the housing; 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; a spring biasing the safety shield toward the activated position; and a first locking mechanism for locking the safety shield in the retracted position, the first locking mechanism being manually releasable by a user to allow the safety shield to reach the activated position.

[0008] The safety shield is rotatable within the body and has a distal portion that protrudes axially from the distal portion of the body for gripping the safety shield, and the first locking mechanism is configured to release the safety shield when the safety shield (3) rotates from the first angular position to the second angular position.

[0009] 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.

[0010] In some embodiments, the second locking mechanism is configured to receive and retain a proximal portion of the safety shield.

[0011] In some embodiments, the second locking mechanism comprises a first retention mechanism provided on an outer surface of a proximal portion of the safety shield that is forcibly deformed when the safety shield moves from the retracted position toward the activated position.

[0012] In some embodiments, the second locking mechanism further comprises second retention mechanisms disposed on an inner surface of the distal portion of the body, the retention mechanisms configured to interact with the first retention mechanisms when the safety shield moves from the retracted position toward the activated position.

[0013] In some embodiments, the distal portion of the safety shield presents texture features to enhance grip.

[0014] In some embodiments, the needle is covered by a safety shield in the activated position and is not covered by a safety shield in the retracted position.

[0015] In some embodiments, the first locking mechanism comprises complementary first and second mating surfaces on the safety shield and the body, respectively.

[0016] In some embodiments, the first mating surface is also part of the first retention feature.

[0017] In some embodiments, the syringe assembly comprises a pre-filled syringe including a barrel, a needle, a stopper, and a plunger rod.

[0018] According to another aspect, the present invention relates to a shielding system for a syringe for use in drug delivery, the syringe including a barrel and a needle at a distal end of the barrel, the shielding system comprising: a tubular body defining a housing, the barrel extending at least partially within the housing; a safety shield for the needle, the safety shield being movable longitudinally relative to the tubular body between a retracted position and an activated position; a spring biasing the safety shield toward the activated position; and a first locking mechanism for locking the safety shield in the retracted position, the first locking mechanism being manually releasable by a user to allow the safety shield to reach the activated position.

[0019] the safety shield is rotatable within the body and has a distal portion that protrudes axially from the distal portion of the body for gripping the safety shield; The first locking mechanism is configured to release the safety shield when the safety shield rotates from the first angular position to the second angular position.

[0020] According to another aspect, the present invention relates to a method of operating a syringe assembly or shield system, the method including rotating a safety shield from a first angular position to a second angular position to cause a spring to release a first locking mechanism to move the safety shield from a retracted position toward an activated position. [Brief explanation of the drawings]

[0021] The present invention and the advantages arising therefrom will become more apparent from the following detailed description taken in conjunction with the accompanying drawings, in which: [Figure 1] FIG. 1 is a top perspective view of one embodiment of a syringe assembly according to the present invention, with the needle safety shield in the retracted position. [Figure 2] 2 is a top perspective view of the syringe assembly shown in FIG. 1 with the needle safety shield in the activated position. [Figure 3] FIG. 3 is a perspective view of the locking mechanism of the syringe assembly (in the state of FIG. 1). [Figure 4] FIG. 4 shows the locking mechanism of the syringe assembly (in the state of FIG. 2). [Figure 5] FIG. 5 is an exploded view of the syringe assembly shown in FIG. DETAILED DESCRIPTION OF THE INVENTION

[0022] Different features of embodiments may be used in combination with other embodiments so long as the combined parts do not conflict with or interfere with the operation of the device or assembly. The present invention is not limited in its application to the details of construction and the arrangement of components set forth in the following description or illustrated in the drawings. The embodiments herein may be modified, implemented, and carried out in various ways. Furthermore, the phraseology and terminology used herein are for purposes of description and should not be considered limiting. The use of "including," "comprising," or "having," and variations thereof, herein encompasses the items listed thereafter, as well as additional items, and their equivalents. Unless otherwise limited, the terms "connected," "coupled," and "attached," and variations thereof, herein are used broadly and encompass both direct and indirect connections, couplings, and attachments. Additionally, the terms "connected" and "coupled," and variations thereof, are not limited to physical or mechanical connections or couplings. Furthermore, terms such as distal, proximal, upper, lower, bottom, and upper are relative terms and are intended to aid in illustration, but are not limiting. The embodiments are not intended to be mutually exclusive, and features of one embodiment can be combined with other embodiments as long as they are not mutually inconsistent. Terms of degree, such as "substantially," "about," and "approximately," are understood by those skilled in the art to refer to a reasonable range around and including a given value, as well as to ranges outside the given value, such as the typical tolerance range associated with the manufacture, assembly, and use of the embodiment. The term "substantially" when referring to a structure or characteristic includes a characteristic that is mostly or completely present within the structure.

[0023] 1 and 2 show perspective views of a syringe assembly 10 according to an embodiment of the present invention in a first and second position, respectively.

[0024] Syringe assembly 10 is intended for use in drug delivery (particularly subcutaneous injection) and preferably comprises a complete syringe 1 (particularly a pre-filled syringe containing a single dose of drug, typically 0.3 ml, 0.5 ml, or 1.0 ml) coupled to a tubular body 2 that provides a shielding function. The syringe typically comprises a barrel 12 having a proximal end 121 and a distal end 122 relative to a longitudinal axis, a needle 11 (or other piercing or connecting element, such as a cannula) secured to the distal end of barrel 12, a stopper 13 slidably disposed within barrel 12, and a plunger rod 14 engageable with the stopper. The needle 11 may be provided with a removable needle cap 15. The barrel 12 defines an internal fluid chamber. Forward movement of plunger rod 14 (along the longitudinal axis) moves stopper 13 from proximal end 121 toward distal end 122 (compare FIGS. 1 and 2), thereby expelling fluid from barrel 12 through needle 11. Proximal rearward movement of plunger rod 14 draws fluid into barrel 12. Glass barrels are common in prefillable or pre-filled syringes, although plastic barrels are also known.

[0025] The syringe barrel 12 is coupled to the tubular body 2. The tubular body 2 is preferably an elongated, generally cylindrically shaped component, particularly made of plastic (preferably a semi-rigid plastic material such as polypropylene), and advantageously defines a generally cylindrical housing that shares the same longitudinal axis as the barrel 12. The tubular body 2 has proximal and distal open ends that provide access to the housing. A finger flange 20 extends radially outward from near the proximal open end of the tubular body 2. The finger flange 20 and the tubular body 2 are designed for ease of handling during injection, allowing for one-handed injections. The syringe assembly 10 also includes a safety shield 3 for the needle 11 that is longitudinally movable relative to the tubular body 2, and thus relative to the barrel 12, between a retracted position and an activated position, and a spring 4 configured to move the safety shield 3. Preferably, the shield is movable along the same longitudinal axis as the longitudinal axis of the barrel 12 and / or the tubular body 2. Like the tubular body 2, the safety shield 3 preferably has an elongated, generally cylindrical portion and is made of plastic, particularly a semi-rigid plastic material such as polypropylene. In some embodiments, the spring 4 can be a metal coil spring, although other energy-emitting elements, such as a deformable blade, are also contemplated. In some embodiments, the length of the safety shield 3 is at least the length of the needle 11.

[0026] Syringe barrel 12 extends at least partially, and preferably substantially entirely, within the housing of tubular body 2. Syringe barrel 12 may be slidably engaged within tubular body 2, and thus may include a radially outwardly extending flange for connecting an existing pre-fillable or pre-filled syringe to tubular body 2. In other embodiments, tubular body 2 may be permanently secured to syringe barrel 12.

[0027] In either case, needle safety shield 3 and spring 4 may be disposed within tubular body 2. Preferably, an annular clearance is maintained within the housing between tubular body 2 and syringe barrel 12 to accommodate shield 3 and spring 4. Safety shield 3 and spring 4 are therefore disposed within tubular body 2 and are appropriately designed and sized in diameter to fit within syringe barrel 12.

[0028] In some embodiments, the needle 11 is covered by the safety shield 3 in the activated position, and is not covered by the safety shield 3 in the retracted position. "Covering" the needle 11 means surrounding the needle tip so that it is not exposed, preventing the risk of injury.

[0029] In other words, in the retracted position, the shield 3 is partially, preferably fully, engaged within the housing of the tubular body 2, exposing the needle 11 for use, while in the activated position (or "extended" position), the shield 3 protrudes axially from the tubular body 2 toward the distal end and is positioned to cover the needle 11.

[0030] The "first state" refers to the state in which the shield 3 is stored in the current syringe assembly (see Figure 1), and the "second state" refers to the state in which the shield 3 is activated in the current syringe assembly (see Figure 2).

[0031] The spring 4 biases the safety shield 3 toward the activated position. For this purpose, the tubular body 2 is provided with a shoulder near its proximal open end, and in the retracted position, the spring 4 is compressed between the shield 3 and the shoulder. The spring 4 thus presses the shield 3 longitudinally. This is because, upon "relaxation" of the spring 4, its distal end moves longitudinally, and the needle safety shield 3 then moves longitudinally, extending proximally from the distal end of the tubular body 2 until it reaches the activated position. In another embodiment, not shown, the proximal end of the spring 4 can be fixed directly to the tubular body 2.

[0032] In some embodiments, the syringe assembly 10 includes a first locking mechanism 31 for securing the safety shield 3 in the retracted position. Indeed, without the first locking mechanism 31, the shield 3 would not be able to maintain the retracted position due to the biasing action of the spring 4. In other words, the first locking mechanism 31 secures the shield 3 and / or the spring 4, thereby preventing the spring 4 from moving the shield 3 longitudinally toward the activated position. The force of the spring 4 alone is insufficient to cause the shield 3 to disengage.

[0033] However, the first locking mechanism 31 may be manually releasable by the user to allow the safety shield 3 to reach the activated position. In other words, the user can deactivate the first locking mechanism 31, thereby stopping it from restricting the movement of the shield 3 and / or the spring 4, by performing the following operation: The spring 4 switches the shield 3 from the retracted position to the activated position. "Activating the shield" refers to manually releasing the first locking mechanism 31, and thus to the "activated" state when the shield 3 is extended.

[0034] The shield 3 is naturally held in the activated position by a spring 4, but when sufficient force is applied, it will return the safety shield 3 to the retracted position, exposing the needle 11. In some embodiments, the syringe assembly can 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 by the user even if the user does not intend to do so. This ensures the safety of the user and the patient, as there is no chance of the needle 11 being re-exposed.

[0035] In summary, the needle safety shield 3 is initially held in the retracted position by the first locking mechanism 31, and then, once drug delivery is complete, the user releases it and the safety shield 3 moves longitudinally to engage the second locking mechanism 32, thereby preventing it from returning to the retracted position.

[0036] Syringe assembly 10 comprises tubular body 2, shield 3, and locking mechanisms 31, 32 that are completely independent of the injection action. For example, while Figure 2 shows plunger rod 14 fully depressed, i.e., the state in which the drug has been fully delivered, in reality, shield 3 can be positioned regardless of the position of plunger rod 14.

[0037] In particular, as shown in Figures 1 and 2, the safety shield 3 is rotatable within the tubular body 2 (typically when the shield 3 is also tubular) and has a distal portion 302 (in some embodiments, a protrusion of at least 1 cm) that protrudes axially from the distal portion 202 of the tubular body 2 for gripping the shield 3. More precisely, the majority of the shield 3 is inside the tubular body 2 and is inaccessible to the user, but this distal portion 302 protrudes outward from the tubular body 2 and can be used by the user to grip and, in particular, manually rotate the shield 3. Preferably, the distal portion 302 of the safety shield 3 has a surface texture (e.g., a drop-shaped one as shown in Figures 1 and 2) to improve grip (i.e., adhesion), thereby facilitating gripping and rotation by the user.

[0038] 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. It should be understood that the first locking mechanism 31 does not prevent rotation of the shield 3, but only axial movement.

[0039] The first angular position can be defined arbitrarily, it is only important that there is at least one angular position (called the first angular position) in which the safety shield 3 is locked in the storage position, and at least one different position (called the second angular position) different from the first angular position in which the safety shield 3 is released.

[0040] The first angular position is a "locked" angular position and the second angular position is an "unlocked" angular position.

[0041] Rotation of the shield 3 (by virtue of the distal portion 302) allows movement from a first angular position to a second angular position, thus enabling the expression "rotation trigger." The relative difference between the first and second angular positions is, for example, 90°, although any angle value can be used. In some embodiments, there can be multiple first and / or second angular positions around the circumference of the shield 3.

[0042] For example, a first angular position at 0°; a second angular position of 90°; another first angular position at 180°; Another second angular position is at 270°.

[0043] The combination of the rotatable shield 3 and the tubular body 2 provides a simple yet highly reliable locking mechanism.

[0044] 3, some embodiments include complementary mating surfaces 311, 312 on the safety shield 3 and the tubular body 2. More precisely, a first mating surface 311 (e.g., a tab) is provided on the outer surface of the shield 3 (typically the proximal portion 301 of the shield 3), and a complementary second mating surface 312 (e.g., another tab) is provided on the inner surface of the tubular body 2 (typically the proximal portion 201 of the tubular body 2). The first mating surface 311 and the second mating surface 312 face each other (are in contact) when the shield 3 is in the first angular position, thereby preventing the shield 3 from moving to the activated position. Each mating surface 311, 312 has only a limited azimuthal range, and after sufficient rotation of the shield 3 (to the second angular position), they no longer face each other, causing the shield 3 to be released. In some embodiments, there may be multiple first mating surfaces 311 and multiple mating surfaces 312, for example, two diametrically opposed pairs (see Figures 3 and 4).

[0045] In another embodiment, the shield 3 is provided with a longitudinal slot, the tubular body 2 is provided with a radial pin (protruding from the inner surface of the tubular body 2 toward the center of the syringe assembly 10) that fits into the longitudinal slot, and the first locking mechanism 31 is configured to hold the radial pin in a proximal portion of the longitudinal slot when the shield 3 is in the first angular position (e.g., a bayonet-style mount with a notch).

[0046] Similarly, a second locking mechanism 32 is provided which is configured to receive and retain the proximal portion 301 of the safety shield 3 .

[0047] In some embodiments, the second locking mechanism 32 is a semi-flexible retainer, preferably including a first retaining portion 321 disposed 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 to the activated position. The first retaining portion 321 may also include a first mating surface 311, such as a tab (see FIG. 4). In other words, in this case, the first mating surface is included in both the first locking mechanism 31 and the second locking mechanism 32. This allows for an overall simple and reliable configuration.

[0048] In the illustrated embodiment, the proximal portion 301 of the shield is divided (by longitudinal cuts) into multiple flexible "strips" at the ends of which are located first mating surfaces 311. The combination of the strips and the first mating surfaces 311 form the first retaining portion 321. Thus, as the safety shield 3 moves from the retracted position to the activated position, each strip presents the first mating surface 311 and is forced to bend.

[0049] In some embodiments, the second locking mechanism 32 can include second retaining portions 322 disposed on the inner surface of the distal portion 202 of the tubular body 2. These second retaining portions 322 are configured to interact with the first retaining portions 321 as the safety shield 3 moves from the retracted position to the activated position, and function to permanently and irreversibly lock the safety shield 3 in the activated position after the first locking mechanism 31 is released. By "interacting" or "cooperating," it is meant that the first and second retaining portions 321, 322 are also complementary and interlock with each other upon contact. In other words, during movement of the shield 3, the first retaining portion 321 is designed to be forced to bend and securely interlock with the second retaining portion 322, thereby achieving a permanent locking mechanism that cannot be released.

[0050] In the embodiment of Figures 3 and 4, the second retaining portions 322 are protrusions (e.g., "tooth-like") protruding from the inner surface of the distal portion 202 of the tubular body 2, and may be V-shaped (i.e., formed at a small angle rather than extending longitudinally). The force of the spring 4 causes the stripes of the first retaining portion 321 to bend as the first mating surface 311 (tab) passes over these protrusions, after which the strip returns to its original position. At this stage, the first mating surface 311 contacts the protrusions of the second retaining portion 322 (this is the "interaction" between the second retaining portion 322 and the first retaining portion 321), and the strip cannot be forced to deform again by an axial force in the opposite direction.

[0051] 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. Indeed, in the activated state, rotation of the shield 3 has no effect on the second locking mechanism 32, so that it is inoperative or even impossible to rotate the shield 3. This is the case in the embodiment of Figure 4, where the projections of the second retaining portion 322 extend from both the top and the side of the first mating surface 311 of the first retaining portion 321, thereby preventing movement of the shield 3 in the activated state.

[0052] Theoretically, the strips could be manually bent by pushing them back through the protrusions. However, the shield 3 is inside the tubular body 2, and its proximal portion 301 remains hidden even in the activated state. Therefore, the above-mentioned user operation is virtually impossible, and since the user cannot reach the first retaining portion 321 and the second retaining portion 322, the second locking mechanism 32 cannot be manually released by the user and is nearly irreversible once locked.

Claims

1. 1. A syringe assembly for use in drug delivery, comprising: a syringe barrel (12) having a needle (11) at a distal end (122) of the syringe barrel (12); a tubular body (2) defining a housing, said barrel (12) extending at least partially within said housing; a safety shield (3) for said needle (11), said safety shield (3) being longitudinally movable relative to said tubular body (2) between a retracted position and an activated position; a spring (4) biasing the safety shield (3) towards the operating position; a first locking mechanism (31) for locking the safety shield (3) in the stored position, the first locking mechanism (31) being manually releasable by a user so that the safety shield (3) reaches the activated position, the safety shield (3) being rotatable within the main body (2) and having a distal portion (302) protruding axially from a distal portion (202) of the main body (2) for gripping the safety shield (3), the first locking mechanism (31) being 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 actuated position after the first locking mechanism (31) is released, the second locking mechanism (32) comprising: a first retaining portion (321) configured to receive and retain a proximal portion (301) of the safety shield (3), the first retaining portion (321) being disposed on an outer surface of the proximal portion (301) of the safety shield (3) and being forcibly deformed when the safety shield (3) moves from the retracted position to the actuated position; and a second retaining portion (322) being disposed on an inner surface of the distal portion (202) of the body (2) and configured to interact with the first retaining portion (321) when the safety shield (3) moves from the retracted position to the actuated position; A syringe assembly comprising:

2. 2. A syringe assembly according to claim 1, wherein the distal portion (302) of the safety shield (3) has a textured surface for increasing grip.

3. 3. A syringe assembly according to claim 1 or claim 2, wherein the needle (11) is covered by the safety shield (3) in the activated position, and is not covered by the safety shield (3) in the retracted position.

4. 4. The syringe assembly of claim 1, wherein the first locking mechanism (31) comprises a first mating surface (311) and a second mating surface (312) on the safety shield (3) and the body (2), respectively, that are complementary to each other.

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

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

7. 1. A shielding system for a syringe (1) for use in drug delivery, comprising a barrel (12) and a needle (11) disposed at a distal end (122) of the barrel (12), a tubular body (2) defining a housing, said barrel (12) extending at least partially within said housing; a safety shield (3) for said needle (11), said safety shield (3) being longitudinally movable relative to said tubular body (2) between a retracted position and an activated position; a spring (4) biasing the safety shield (3) towards the operating position; a first locking mechanism (31) for locking the safety shield (3) in the stored position, the first locking mechanism (31) being manually releasable by a user so that the safety shield (3) reaches the activated position, the safety shield (3) being rotatable within the main body (2) and having a distal portion (302) protruding axially from a distal portion (202) of the main body (2) for gripping the safety shield (3), the first locking mechanism (31) being 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 actuated position after the first locking mechanism (31) is released, the second locking mechanism (32) comprising: a first retaining portion (321) configured to receive and retain a proximal portion (301) of the safety shield (3), the first retaining portion (321) being disposed on an outer surface of the proximal portion (301) of the safety shield (3) and being forcibly deformed when the safety shield (3) moves from the retracted position to the actuated position; and a second retaining portion (322) being disposed on an inner surface of the distal portion (202) of the body (2) and configured to interact with the first retaining portion (321) when the safety shield (3) moves from the retracted position to the actuated position; A shield system comprising:

8. 8. A method of operating a syringe assembly according to any one of claims 1 to 6 or a shield system according to claim 7, comprising the step of rotating the safety shield (3) from the first angular position to the second angular position so that the spring (4) moves the safety shield (3) from the retracted position towards the activated position, thereby causing the first locking mechanism (31) to be released.

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