WO2024110442A1 - Safety device for mounting onto a drug delivery device - Google Patents

Abstract

Safety device for mounting onto a drug delivery device The invention concerns a safety device (10) for mounting onto a drug delivery device (100) having a barrel (102) including with 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) including: a collar (2) having at least one locking member configured to lock said 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 said 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 configured to achieve an elastic deformation storing energy when the collar (2) is urged towards the sleeve (3) and releases said energy when the sleeve (3) locking member which includes at least one leg (6), which extends in cantilever from the sleeve (3) towards the collar (2), said at least one leg (6) having a leg hook member (7) configured to hook onto the barrel flange (107) being operable to unlock the sleeve (3) from the barrel (102) so as to release the energy stored in the flexible member when the sleeve (3) is unlocked from the barrel (102).

Description

Safety device for mounting onto a drug delivery device

The present invention relates to a safety device for mounting onto a drug delivery device such as a prefilled or pre-fillable syringe in order to protect a user from needle stick injuries after injection of a medical product. The invention also relates to a drug delivery device including this safety device.

Background

In this application, the distal end of a component or of a device is to be understood as meaning the end furthest from the user's hand and the proximal end is to be understood as meaning the end closest to the user's hand. Likewise, in this application, the "distal direction" is to be understood as meaning the direction of injection, with respect to the safety device or drug delivery device of the invention and the "proximal direction" is to be understood as meaning the opposite direction to said direction of injection, that is to say the direction towards the user’s hand.

Drug delivery devices, such as pre-fillable or prefilled syringes, usually comprise a hollow body or barrel forming a container for a medical product. This body comprises a distal end in the form of a longitudinal tip defining an axial passageway through which the medical product is expelled from the container. The distal end is equipped with a needle for injection of the medical product into an injection site.

It is of great importance that the patients and users are protected from any risk of needle stick injuries, particularly between the moment that injection is finished and the discarding of the drug delivery device.

In order to minimize the risks of needle stick injuries, drug delivery devices may be equipped with a safety device that protects the needle after injection.

Although known safety devices are generally satisfactory, they do not always meet all of the user's expectations and they can include a number of components. Therefore, they can be expensive to manufacture and thus this can limit the widespread use of safety devises at the expense of the security of medical users and patients.

They also tend to include components made of various materials, which can be complex and expensive to recycle.

SUBSTITUTE SHEET (RULE 26) Summary

A need exists for an improved safety that provides a user with more convenient safety device that is also cost effective and easy to manufacture.

In one aspect, the invention concerns a safety device for mounting onto a drug delivery device having a barrel including with a flange at its proximal end and an injection needle at its distal end, and a piston rod having a piston flange, the safety device including: a collar having at least one locking member configured to lock said 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 said sleeve relative to the barrel; a flexible member connecting the collar and the sleeve and maintaining the collar and the sleeve axially spaced apart configured to achieve an elastic deformation storing energy when the collar is urged towards the sleeve and releases said energy when the sleeve locking member being 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.

Various other embodiments of the invention may include the following:

- The flexible member include at least one elastic 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 axially projecting in cantilever from the collar in a proximal direction, said hook member having a sloped ramp surface at its free end.

- The collar includes two collar hook members spaced apart by 180°.

- The collar includes at least one finger member projecting in cantilever from the collar in a distal direction, said finger member having a proximal and a distal sloped ramp surfaces radially oriented in an inward direction and substantially forming a triangle.

- The collar includes two finger members spaced apart by 180°.

SUBSTITUTE SHEET (RULE 26) - The sleeve includes at least one leg, which extends in cantilever from the sleeve towards the collar, said at least one leg having a leg hook member configured to hook onto the barrel flange.

- The at least one leg includes an inwardly facing U shaped part and an adjacent ramped ear.

- The sleeve includes two legs .

- The at least one finger member is angularly positioned on the collar to be axially aligned with the at least one leg.

- The safety device is manufactured in a single shot injection molding process.

In an other aspect, the invention concerns a drug delivery device having a barrel including with a flange at its proximal end and an injection needle at its distal end, and a piston rod including a piston flange fitted with a safety device as above disclosed.

The piston flange may include two flat parts alternating with two rounds ears.

Brief description of the drawings

With reference to the appended drawings, below follows a more detailed description of aspects and embodiments of the invention cited as examples.

Figs.1 and 2 are perspective views of a safety device according to one embodiment of the invention mounted on a drug delivery device;

Fig.3 is an exploded view of the safety device and of the drug delivery device of Figs.1 and 2;

Fig.4 is a perspective view of the safety device and the drug delivery device during an injection;

Fig.5 is a perspective view of the safety device and the drug delivery device after an injection;

Figs.6 to 10 are perspective views of the safety device without the drug delivery device.

Description of the invention

SUBSTITUTE SHEET (RULE 26) The different features of the embodiments can be used in combination with and used with other embodiments as long as the combined parts are not inconsistent with or interfere with the operation of the device and assembly. This 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 are capable of being modified, practiced or carried out in various ways. The phraseology and terminology used herein is for the purpose of description and should not be regarded as limiting. The use of "including," "comprising," or "having" and variations thereof herein is to encompass the items listed thereafter and equivalents thereof as well as additional items. Unless limited otherwise, the terms "connected," "coupled," and "mounted," and variations thereof herein are used broadly and encompass direct and indirect connections, couplings, and mountings. In addition, the terms "connected" and "coupled" and variations thereof are not limited to physical or mechanical connections or couplings. Further, terms such as distal, proximal, up, down, bottom, and top are relative, and are to aid illustration, but are not limiting. The embodiments are not intended to be mutually exclusive so that the features of one embodiment can be combined with other embodiments as long as they do not contradict each other. Terms of degree, such as “substantially”, “about” and “approximately” are understood by those skilled in the art to refer to reasonable ranges around and including the given value and ranges outside the given value, for example, general tolerances associated with manufacturing, assembly, and use of the embodiments. The term “substantially” when referring to a structure or characteristic includes the characteristic that is mostly or entirely present in the structure.

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 of a glass material. This barrel 102 has a distal shoulder 103 provided with a distal tip 104 longitudinally protruding from said shoulder 103 along a longitudinal axis A. The distal tip 104 defines an axial passageway in fluid communication with the reservoir and is equipped with the injection needle 101 for injecting the medical product in an injection site. The barrel 102 further includes an opposite opened proximal end provided with a flange 107. In

SUBSTITUTE SHEET (RULE 26) some embodiments, the flange 107 can include two flat parts 108 alternating with two rounds ears 109.

The opened proximal end receives a plunger rod 110 for pushing a stopper 112 located inside the barrel 102 to expel the medical product from the reservoir to the injection site via the distal tip 104 and the injection needle 101. The plunger rod 110 is provided with a plunger flange 114 whereon a user can apply a thumb.

The drug delivery device 100 may be fitted with a tip cap 113 for protecting and sealing the injection needle 101 before injection.

Turning to Figs.6 to 9, the safety device 10 includes a collar 2 at its proximal end and a sleeve 3 at its distal end. The collar 2 and the sleeve 3 are connected by flexible members, which can store mechanical energy when they are deflected under a load and can give back the mechanical energy when the load ceases. In some embodiments, two blades 4 join the collar 2 and the sleeve 3.

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

The blades 4 are further configured to deflect in an outward and radial direction as the sleeve 3 and collar 2 become axially closer, for example, when a load applies on the collar 2 while the sleeve 3 is stationary.

The sleeve 3 is configured and sized to engage on the barrel 102. In some embodiments, the sleeve 3 includes two legs 6, which extend in cantilever from the sleeve 3 towards the collar 2. In other embodiments not shown, the safety device may include two or more legs such as three or four legs. The legs 6 can bend elastically in a radial direction relative to the sleeve 3.

At their free end, each leg 6 include a leg hook member 7, which is comprised of a U shaped part 8 inwardly facing and a ramped ear 9. The U shaped part 8 forms a groove configured and sized to engage into the flange 107.

In some embodiments, the legs 6 and blades 4 are paired two by two symmetrically relative to the A axis. In some embodiments, a leg 6 and a blade 4 are disposed side by side over an angle a between 25° and 45° as shown on Fig.10. Thus, the two pairs of leg 6 and blade 4 define two large lateral openings.

The collar 2 is a hollow circular part having a central opening configured and sized to receive the barrel 102 and the flange 107.

SUBSTITUTE SHEET (RULE 26) As best seen on Fig.8 and 9, the collar 2 includes two collar hook members 11 and two opposite finger member 12.

Each collar hook members 11 includes a tab 14, which axially projects in cantilever from the collar 2 in a proximal direction. The end of the tab 14 includes a sloped ramp surface 15 radially oriented in an inward direction.

In the illustrated embodiment, the safety device 10 is provided with two collar hook members 11 , which are positioned at 180 degrees from each other. In other embodiments, the safety device can be provided with three or more collar hook members.

Each finger member 12 includes a tab 17, which axially projects in cantilever from the collar 2 in a proximal direction. The end of the tab 17 includes two proximal and distal sloped ramp surfaces 18, 19 radially oriented in an inward direction which substantially form a triangle. The two finger members 12 are angularly positioned on the collar 2 to be axially aligned with the legs 6.

The safety device 10 may be manufactured by a molding process such as injection molding process using a thermoplastic and/or thermoplastic (TPE) or other disposable and/or recyclable material or combination thereof. Other suitable processes may be utilized such as 3D printing.

One can appreciate that in some embodiments the safety device 10 is a one-piece component, which can be manufactured in a single injection molding process, which would speed production. The safety device can therefore be made of a single material to facilitate recycling of the device.

To assemble the safety device 10 onto a drug delivery device such as the drug delivery device 100, which can be a prefilled syringe, the distal end of said drug delivery device 100 engages into the collar 2; the sleeve 3 guides the barrel 102. At the end of the drug delivery device 100 push into the safety device 10, the flange 107 locks into the leg hook member 7 and thus the safety device 10 is axially retained onto the barrel 102. In some embodiments, the flange flat parts 108 lock into in U shaped parts 8 of the leg hook members 7.

Simultaneously, the piston flange 114 abuts against the collar hook member 11 . The piston flange 114 slides over the sloped ramped surface 12 of each collar hook member which deflect radially in an outward direction. This allows the piston flange 114 to lock into the proximal collar hook member 11 .

The drug delivery device 100 is axially locked by the safety device 100 (i) through its flange 107, which is locked on the leg hook member 7

SUBSTITUTE SHEET (RULE 26) and (ii) through its piston flange 114 which is locked on the collar hook member 11.

In this state shown on Figs.1 and 2, the drug delivery device 100 fitted with the safety device 10 can be stored for future use. One can note that the safety device is under no stress and therefore a long-term storage will not affect its capabilities.

When an injection of the drug contained in the drug delivery device 100, a user may first remove the tip cap 113.

The drug delivery device 100 is ready for injection. The user can visually check the drug through the openings defined by the two pairs of leg 6 and blade 4.

Administering an injection with a syringe fitted with the safety device 10 is substantially the same as administering an injection with a syringe fitted with the safety device according to the prior art and thus is not likely to confuse a user and permits a user-friendly operation.

In an exemplary use illustrated on Figs.1 to 5, a user can apply a pushing force on the piston rod flange 114 typically by applying a thumb on the piston rod flange 114 while the user maintains one finger - typically the index - on one round ear 109 and one finger - typically the middle finger - on the other round ear 109.

As the injection progresses, the piston rod flange 114 moves closer to the flange 107.

As the collar 2 is locked onto the piston rod flange 114 and as the flange 107 is locked onto the legs, the blades 4 deflect in a radially outward direction as shown on Fig.7 and store mechanical energy.

At the end of the injection, the finger members 12 abuts against the sloped ramped surface 9 of the leg hook member 8. By an additional push on the piston rod 114, the distal sloped ramp surface 19 of the fingers 12 comes in abutment with the ramped ear 9 provided at the end of the leg hook members 7. The leg hook members 7 are thus forced to deflect outwardly thereby releasing the flange 107. The blades 6 are free to release their mechanical energy and axially push the sleeve 3 in the distal direction. The needle 101 is then enclosed by the sleeve 3 and is protected.

Simultaneously, the flange 107 locks into the distal sloped surface 19 of the finger members 12.

SUBSTITUTE SHEET (RULE 26) The protective device 10 accordingly achieves a substantially permanent locking of the tubular body 12 over the needle tip 101 without any input from the user as the blades 4 harvest mechanical energy during the injection, which is used to move the safety device 10 into a safety position where the sleeve 3 encloses the needle 101 .

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 the terms "comprises," "comprising," "includes," and/or "including" when used herein specify the presence of stated features, integers, steps, operations, elements, and/or components, but do not preclude the presence or addition of one or more other features, integers, steps, operations, elements, components, and/or groups thereof.

It will be understood that, although the terms first, second, etc., may be used herein to describe various elements, these elements should not be limited by these terms. These terms are only used to distinguish one element from another. For example, a first element could be termed a second element, and, similarly, a second element could be termed a first element without departing from the scope of the present disclosure.

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

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 terms used herein should be interpreted as having a meaning

SUBSTITUTE SHEET (RULE 26) consistent with their meaning in the context of this specification and the relevant art and will not be interpreted in an idealized or overly formal sense unless expressly so defined herein.

It is to be understood that the present disclosure is not limited to the aspects described above and illustrated in the drawings; rather, the skilled person will recognize that changes and modifications may be made within the scope of the appended claims.

SUBSTITUTE SHEET (RULE 26)

Claims

1 . A safety device (10) for mounting onto a drug delivery device (100) having a barrel (102) including with 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) including: a collar (2) having at least one locking member configured to lock said 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 said 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 configured to achieve an elastic deformation storing energy when the collar (2) is urged towards the sleeve (3) and releases said energy when the sleeve locking member which includes at least one leg (6), which extends in cantilever from the sleeve (3) towards the collar (2), said at least one leg (6) having a leg hook member (7) configured to hook onto the barrel flange (107) being operable to unlock the sleeve (3) from the barrel (102) so as to release the energy stored in the flexible member when the sleeve (3) is unlocked from the barrel (102).

2. The safety device of claim 1 , wherein the flexible member include at least one elastic blade (4) connecting the sleeve (3) and the collar (2).

3. The safety device of any one of claims 1 to 2, wherein the collar (2) includes at least one collar hook member (11 ) configured to lock onto the piston flange (107), said collar hook member (11 ) axially projecting in cantilever from the collar (2) in a proximal direction, said hook member having a sloped ramp surface (15) at its free end.

4. The safety device of claim 3, wherein the collar (2) includes two collar hook members (11 ) spaced apart by 180°.

5. The safety device of any one of claims 1 to 4, wherein the collar (2) includes at least one finger member (12) projecting in cantilever from the collar (2) in a distal direction, said finger member (12) having a proximal and a distal sloped ramp surfaces (18,19) radially oriented in an inward direction and substantially forming a triangle.

6. The safety device of claim 5, wherein the collar (2) includes two finger members (12) spaced apart by 180°.

7. The safety device of any of claims 1 to 6, wherein the at least one leg (6) includes an inwardly facing U shaped part (8) and an adjacent ramped ear (9).

8. The safety device of any of claims 1 to 7, wherein the sleeve (3) includes two legs (6).

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

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

11 . A drug delivery device (100) having a barrel (102) including 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) fitted with a safety device (100) according to one of claims 1 to 10

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