Safety device for attachment to a drug delivery device - Patent Application 20070122997

Abstract

The present invention relates to a safety device (10) for attachment to a drug delivery device (100) having a barrel (102) including a flange (107) at its proximal end and an injection needle (101) at its distal end, and a piston rod (110) having a piston flange (114), the safety device (10) comprising: a collar (2) having at least one locking member configured to lock the collar (2) relative to the piston flange (114); a sleeve (3) configured to slide over the barrel (102), the sleeve (3) having at least one locking member configured to lock the sleeve (3) relative to the barrel (102); a flexible member connecting the collar (2) and the sleeve (3) and maintaining the collar (2) and the sleeve (3) axially spaced apart, the flexible member being configured to achieve elastic deformation that stores energy when the collar (2) is pressed toward the sleeve (3) and the energy is released; a sleeve (3) locking member including at least one leg (6) cantilevered from the sleeve (3) toward the collar (2), the at least one leg (6) having a leg hook member (7) configured to hook onto the barrel flange (107), the leg hook member (7) operable to unlock the sleeve (3) from the barrel (102) to release the energy stored in the flexible member when the sleeve (3) is unlocked from the barrel (102).

Description

[Technical Field]

[0001] The present invention relates to a safety device for attachment to a drug delivery device, such as a pre-filled or pre-fillable syringe, to protect a user from needlestick injuries after injection of a medical product. The present invention also relates to a drug delivery device including the safety device. [Background technology]

[0002] In this application, the distal end of a component or device shall be understood to mean the end furthest from the user's hand, and the proximal end shall be understood to mean the end closest to the user's hand. Similarly, in this application, a "distal direction" shall be understood to mean the direction of injection with respect to the safety device or drug delivery device of the present invention, and a "proximal direction" shall be understood to mean the direction opposite to said direction of injection, i.e., towards the user's hand.

[0003] Drug delivery devices, such as prefillable or pre-filled syringes, typically include a hollow body or barrel forming a reservoir for a medical product, the body having a distal end in the form of a longitudinal tip defining an axial passageway through which the medicinal product is expelled from the reservoir, and the distal end being equipped with a needle for injecting the medical product at an injection site.

[0004] It is very important that patients and users are protected from the risk of needlestick injuries, especially from the moment the injection is completed until the drug delivery device is disposed of.

[0005] To minimize the risk of needlestick injuries, drug delivery devices may be equipped with a safety device that protects the needle after injection.

[0006] Known safety devices, while generally satisfactory, do not necessarily meet all of a user's expectations and may include several components, therefore they may be expensive to manufacture, which may therefore limit widespread use of the safety devices at the expense of healthcare user and patient safety.

[0007] They also tend to contain components made from a variety of materials, which can be complex and expensive to recycle. Summary of the Invention

[0008] There is also a need for improved safety that provides users with more convenient safety devices that are cost effective and easy to manufacture.

[0009] In one aspect, the present invention relates to a safety device for attachment to a drug delivery device having a barrel with a flange at its proximal end and with an injection needle at its distal end, and a piston rod having a piston flange, the safety device comprising: a collar having at least one locking member configured to lock the collar relative to the piston flange; a sleeve configured to slide over the barrel, the sleeve having at least one locking member configured to lock the sleeve relative to the barrel; a flexible member connecting the collar and the sleeve and maintaining the collar and the sleeve axially spaced apart, the flexible member configured to achieve an elastic deformation that stores energy when the collar is pushed toward the sleeve and the energy is released; the sleeve locking member operable to unlock the sleeve from the barrel so as to release the energy stored in the flexible member when the sleeve is unlocked from the barrel.

[0010] Various other embodiments of the present invention may include the following. The flexible member includes at least one resilient blade connecting the sleeve and the collar. - the collar includes at least one collar hook member configured to lock onto the piston flange, said collar hook member cantilevering axially from the collar in a proximal direction, said hook member having an inclined ramp surface at its free end. The collar includes two collar hook members spaced 180° apart. - the collar includes at least one finger member protruding cantilevered from the collar in a distal direction, said finger member having proximally and distally inclined ramps oriented radially inwardly to form a substantially triangular shape. The collar includes two finger members spaced 180° apart. The sleeve includes at least one leg cantilevered from the sleeve toward the collar, the at least one leg having a leg hook member configured to hook onto the barrel flange. At least one leg includes an inwardly directed U-shaped portion and an adjacent angled ear. - The sleeve includes two legs. The at least one finger member is angularly disposed on the collar so as to be axially aligned with the at least one leg. - The safety device is manufactured in a single-shot injection molding process.

[0011] In another aspect, the present invention relates to a drug delivery device comprising a barrel having a flange at its proximal end and having an injection needle at its distal end, and a piston rod including a piston flange attached to a safety device as disclosed above.

[0012] The piston flange may include two flat portions alternating with two rounded ears. [Brief explanation of the drawings]

[0013] With reference to the accompanying drawings, the following follows a more particular description of aspects and embodiments of the invention, cited by way of example. [Figure 1] FIG. 1 is a perspective view of a safety device according to one embodiment of the present invention attached to a drug delivery device. [Figure 2] FIG. 2 is a perspective view of a safety device according to one embodiment of the present invention attached to a drug delivery device. [Figure 3] FIG. 3 is an exploded view of the safety device and drug delivery device of FIGS. [Figure 4] FIG. 4 is a perspective view of the safety device and drug delivery device during injection. [Figure 5] FIG. 5 is a perspective view of the safety device and drug delivery device after injection. [Figure 6] FIG. 6 is a perspective view of the safety device without the drug delivery device. [Figure 7] FIG. 7 is a perspective view of the safety device without the drug delivery device. [Figure 8] FIG. 8 is a perspective view of the safety device without the drug delivery device. [Figure 9] FIG. 9 is a perspective view of the safety device without the drug delivery device. [Figure 10] FIG. 10 is a perspective view of the safety device without the drug delivery device. DETAILED DESCRIPTION OF THE INVENTION

[0014] Different features of the embodiments may be used in combination with other embodiments so long as the combined parts do not conflict 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, or performed 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 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.

[0015] The drug delivery device 100 may be a prefilled or prefillable syringe. The drug delivery device 100 includes a tubular barrel 102 defining a reservoir for containing a medical product, such as a drug. The tubular barrel 102 may be made of a plastic or glass material. The barrel 102 has a distal shoulder 103 with a distal tip 104 protruding longitudinally from the shoulder 103 along a longitudinal axis A. The distal tip 104 defines an axial passage in fluid communication with the reservoir and is equipped with an injection needle 101 for injecting the medical product at an injection site. The barrel 102 further includes an opposite, open proximal end with a flange 107. In some embodiments, the flange 107 includes two flat portions 108 alternating with two rounded ears 109.

[0016] The open proximal end receives a plunger rod 110 for pressing a stopper 112 located within the barrel 102, expelling the medical product from the reservoir through the distal tip 104 and the injection needle 101 into the injection site. The plunger rod 110 is provided with a plunger flange 114 against which the user can apply their thumb.

[0017] The drug delivery device 100 may be fitted with a tip cap 113 to protect and seal the injection needle 101 prior to injection.

[0018] 6-9, safety device 10 includes a collar 2 at its proximal end and a sleeve 3 at its distal end. Collar 2 and sleeve 3 are connected by a flexible member that can store mechanical energy when deflected under load and return mechanical energy when the load is stopped. In some embodiments, two blades 4 join collar 2 and sleeve 3.

[0019] The blades 4 are configured to maintain the sleeve 3 and collar 2 axially spaced apart and substantially coaxial.

[0020] The blades 4 are further configured to deflect outwardly and radially as the sleeve 3 and collar 2 converge axially, for example, when a load is applied to the collar 2 while the sleeve 3 is stationary.

[0021] The sleeve 3 is configured and sized to engage the barrel 102. In some embodiments, the sleeve 3 includes two legs 6 that cantilever from the sleeve 3 toward the collar 2. In other embodiments not shown, the safety device may include more than two legs, such as three or four legs. The legs 6 are resiliently bendable radially relative to the sleeve 3.

[0022] At their free ends, each leg 6 includes a leg hook member 7 with an inwardly facing U-shaped portion 8 and an angled ear 9. The U-shaped portion 8 forms a groove configured and sized to engage a flange 107.

[0023] In some embodiments, the legs 6 and blades 4 are arranged in pairs symmetrically about axis A. In some embodiments, the legs 6 and blades 4 are arranged side by side on an angle α between 25° and 45°, as shown in Figure 10. Thus, the two pairs of legs 6 and blades 4 define two large lateral openings.

[0024] Collar 2 is a hollow circular portion having a central opening configured and sized to receive barrel 102 and flange 107 .

[0025] As best seen in FIGS. 8 and 9, collar 2 includes two collar hook members 11 and two opposing finger members 12.

[0026] Each collar hook member 11 includes a tab 14 that cantilevers axially proximally from collar 2. The end of tab 14 includes an inclined ramp 15 oriented radially inward.

[0027] In the illustrated embodiment, the safety device 10 includes two collar hook members 11 positioned 180 degrees apart from each other. In other embodiments, the safety device may include three or more collar hook members.

[0028] Each finger member 12 includes a tab 17 that cantilevers axially proximally from the collar 2. The ends of the tabs 17 include two proximal and distal angled ramps 18, 19 oriented radially inwardly to form a substantially triangle. The two finger members 12 are angularly positioned on the collar 2 so as to be axially aligned with the legs 6.

[0029] The safety device 10 may be manufactured by a molding process, such as an injection molding process, using thermoplastic and / or thermoplastic polyethylene (TPE) or other disposable and / or recyclable materials or combinations thereof. Other suitable processes, such as 3D printing, may be utilized.

[0030] It can be appreciated that in some embodiments, the safety device 10 is a one-piece component that can be manufactured in a single injection molding process, which speeds production, and thus the safety device can be made of a single material to facilitate recycling of the device.

[0031] To assemble the safety device 10 onto a drug delivery device, such as drug delivery device 100, which may be a pre-filled syringe, the distal end of said drug delivery device 100 engages with collar 2 and sleeve 3 guides barrel 102. When the end of drug delivery device 100 is pushed onto safety device 10, flange 107 locks into leg hook member 7, thus holding safety device 10 axially on barrel 102. In some embodiments, flange flat portion 108 locks into U-shaped portion 8 of leg hook member 7.

[0032] At the same time, piston flange 114 abuts against collar hook member 11. Piston flange 114 slides over the inclined ramp surface 12 of each collar hook member that flexes radially outward, thereby locking piston flange 114 to the proximal collar hook member 11.

[0033] The drug delivery device 100 is axially locked by the safety device 100 (i) via its flange 107 which is locked to the leg hook member 7, and (ii) via its piston flange 114 which is locked to the collar hook member 11.

[0034] 1 and 2, the drug delivery device 100 with the safety device 10 attached can be stored for future use. It is understood that the safety device is not under stress and therefore long-term storage will not affect its functionality.

[0035] When injecting a drug contained in drug delivery device 100, the user may first remove tip cap 113.

[0036] The drug delivery device 100 is now ready for injection. The user can visually see the drug through the opening defined by the two pairs of legs 6 and blades 4.

[0037] Administering an injection with a syringe attached to safety device 10 is substantially the same as administering an injection with a syringe attached to a prior art safety device, and therefore does not confuse the user, allowing for user-friendly operation.

[0038] In the exemplary use shown in Figures 1 to 5, a user can typically apply a pushing force to the piston rod flange 114 by applying a thumb to the piston rod flange 114, while maintaining one finger (typically the index finger) on one rounded ear 109 and one finger (typically the middle finger) on the other rounded ear 109.

[0039] As the injection progresses, the piston rod flange 114 moves closer to the flange 107. When the collar 2 is locked to the piston rod flange 114 and the flange 107 is locked to the leg, the blades 4 deflect radially outward as shown in Figure 7, storing mechanical energy.

[0040] At the end of the injection, the finger members 12 abut against the inclined ramps 9 of the leg hook member 8. By further pushing the piston rod 114, the distal inclined ramps 19 of the fingers 12 come into contact with the inclined ears 9 at the ends of the leg hook member 7. The leg hook member 7 is thus forced to flex outward, thereby releasing the flanges 107. The blades 6 are free to release their mechanical energy, pushing the sleeve 3 axially in the distal direction. The needle 101 is then surrounded and protected by the sleeve 3.

[0041] At the same time, flange 107 is locked onto distal ramp 19 of finger member 12 .

[0042] Thus, the protection device 10 achieves a substantially permanent locking of the tubular body 12 on the needle tip 101 without input from the user when the blade 4 collects mechanical energy during injection, which is used to move the safety device 10 to a safe position where the sleeve 3 surrounds the needle 101.

[0043] The terminology used herein is for the purpose of describing particular aspects only and is not intended to be limiting of the disclosure. As used herein, the singular forms "a," "an," and "the" are intended to include the plural forms as well, unless the context clearly indicates otherwise. As used herein, the term "and / or" includes any and all combinations of one or more of the associated listed items. It will be further understood that as used herein, the terms "comprises," "comprising," "includes," and / or "including" specify the presence of stated features, integers, steps, operations, elements, and / or components, but do not exclude the presence or addition of one or more other features, integers, steps, operations, elements, components, and / or groups thereof.

[0044] Terms such as "first," "second," and the like may be used herein to describe various elements, but it will be understood that these elements should not be limited by these terms. These terms are used only to distinguish one element from another. For example, a first element may be referred to as a "second element," and similarly, a second element may be referred to as a "first element" without departing from the scope of the present disclosure.

[0045] Relative terms such as "below" or "above" or "upper" or "lower" or "horizontal" or "vertical" may be used herein to describe the relationship of one element to another element, as shown in the figures. It should be understood that these terms, and those described above, are intended to encompass different orientations of the device in addition to the orientation shown in the figures. When an element is referred to as being "connected" or "coupled" to another element, it should be understood that it may be directly connected or coupled to the other element, or there may be intervening elements. In contrast, when an element is referred to as being "directly connected" or "directly coupled" to another element, there are no intervening elements present.

[0046] Unless otherwise defined, all terms (including technical and scientific terms) used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this disclosure belongs. It will be further understood that the terms used herein should be interpreted to have a meaning consistent with their meaning in the context of the present specification and related art, and should not be interpreted in an idealized or overly formal sense unless expressly defined herein.

[0047] It is to be understood that the present disclosure is not limited to the embodiments described above and shown in the drawings, but rather, those skilled in the art will recognize that changes and modifications may be made within the scope of the appended claims.

Claims

1. A safety device (10) for attachment to a drug delivery device (100) having a barrel (102) with a flange (107) at its proximal end and an injection needle (101) at its distal end, and a piston rod (110) with a piston flange (114), comprising: a collar (2) having at least one locking member configured to lock the collar (2) relative to the piston flange (114); a sleeve (3) configured to slide over the barrel (102), the sleeve (3) having at least one locking member configured to lock the sleeve (3) relative to the barrel (102); a flexible member connecting the collar (2) and the sleeve (3) and maintaining the collar (2) and the sleeve (3) axially spaced apart, the flexible member being configured to achieve an elastic deformation that stores energy when the collar (2) is pressed toward the sleeve (3) and the energy is released; the sleeve lock member including at least one leg (6) cantilevered from the sleeve (3) toward the collar (2) having a leg hook member (7) configured to hook onto the barrel flange (107), the leg hook member being operable to unlock the sleeve (3) from the barrel (102) to release the energy stored in the flexible member when the sleeve (3) is unlocked from the barrel (102); A safety device (10) comprising:

2. 2. A safety device according to claim 1, wherein the flexible member comprises at least one resilient blade (4) connecting the sleeve (3) and the collar (2).

3. 3. A safety device according to claim 1, wherein the collar (2) includes at least one collar hook member (11) configured to lock onto the piston flange (107), the collar hook member (11) axially protruding in a cantilevered manner from the collar (2) in a proximal direction, the hook member having an inclined ramp surface (15) at its free end.

4. 4. A safety device according to claim 3, wherein the collar (2) comprises two collar hook members (11) spaced 180° apart.

5. 5. A safety device according to any one of claims 1 to 4, wherein the collar (2) includes at least one finger member (12) cantilevered distally from the collar (2), the finger member (12) having proximal and distal inclined ramps (18, 19) oriented radially inward and forming a substantially triangular shape.

6. 6. A safety device as claimed in claim 5, wherein the collar (2) includes two finger members (12) spaced 180° apart.

7. A safety device according to any one of claims 1 to 6, wherein the at least one leg (6) includes an inwardly directed U-shaped portion (8) and adjacent beveled ears (9).

8. A safety device according to any one of claims 1 to 7, wherein the sleeve (3) comprises two legs (6).

9. 9. A safety device according to any one of claims 1 to 8, wherein the at least one finger member (12) is angularly disposed on the collar (2) so as to be axially aligned with the at least one leg (6).

10. A safety device according to any one of claims 1 to 9, wherein the safety device (10) is manufactured in a single shot injection moulding process.

11. A drug delivery device (100) having a barrel (102) with a flange (107) at its proximal end and an injection needle (101) at its distal end, and a piston rod (110) including a piston flange (114) to which a safety device (100) according to any one of claims 1 to 10 is attached.

12. 12. The drug delivery device (100) of claim 11, wherein the piston flange comprises two flat portions (108) alternating with two rounded ears (109).

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