CN120265343A

CN120265343A - Safety device for mounting on a drug delivery device

Info

Publication number: CN120265343A
Application number: CN202380080750.1A
Authority: CN
Inventors: B·泽勒
Original assignee: Becton Dickinson France SA
Current assignee: Becton Dickinson France SA
Priority date: 2022-11-22
Filing date: 2023-11-21
Publication date: 2025-07-04
Also published as: WO2024110442A1; EP4622691A1

Abstract

The invention relates to a safety device (10) for mounting on a drug delivery device (100), the drug delivery device having a barrel (102) and a piston rod (110), the barrel comprising a flange (107) at its proximal end and an injection needle (101) at its distal end, the piston rod having a piston flange (114), the safety device (10) comprising: a collar (2) having at least one locking member, the locking member being configured to lock the collar (2) relative to the piston flange (114); a sleeve (3) being configured to slide on the barrel (102), the sleeve (3) having at least one locking member, the sleeve (3) being configured to lock the sleeve (114) relative to the barrel (102). 3); a flexible member connecting the collar (2) and the sleeve (3) and keeping the collar (2) and the sleeve (3) axially spaced apart, the flexible member being configured to achieve elastic deformation of stored energy when the collar (2) is pushed toward the sleeve (3) and to release energy when the sleeve (3) is unlocked from the barrel (102), the locking member of the sleeve (3) comprising at least one leg (6) extending from the sleeve (3) toward the collar (2) in a cantilevered manner, the leg (6) having a leg hook member (7) configured to be hooked onto a barrel flange (107), the leg hook member being operable to unlock the sleeve (3) from the barrel (102) so as to release energy stored in the flexible member when the sleeve is unlocked from the barrel.

Description

Safety device for mounting to a drug delivery device

Technical Field

The present invention relates to a safety device for mounting to a drug delivery device, such as a prefilled or prefillable 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 comprising such a safety device.

Background

In the present application, the distal end of a component or device should be understood to refer to the end furthest from the user's hand, while the proximal end should be understood to refer to the end closest to the user's hand. Also in the present application "distal direction" should be understood to refer to the injection direction with respect to the safety device or the drug delivery device of the present application, whereas "proximal direction" should be understood to refer to the direction opposite to said injection direction, i.e. towards the hand of the user.

Drug delivery devices such as prefillable or prefillable syringes typically comprise a hollow body or barrel forming a container for a medical product. The body includes a distal end in the form of a longitudinal tip defining an axial passageway through which medical product is discharged from the container. The distal end is equipped with a needle for injecting a medical product into the injection site.

It is important to protect the patient and the user from any risk of needle stick injuries, especially during the period between the end of injection and the disposal of the drug delivery device.

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

While known safety devices are generally satisfactory, they do not always meet all of the user's desires, and they may contain many components. Thus, their manufacturing costs can be high, which can limit the widespread use of safety devices at the expense of safety for medical users and patients.

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

Disclosure of Invention

There is a need for an improved safety solution that provides a more convenient safety device for the user, which is also cost-effective and easy to manufacture.

In one aspect, the present invention relates to a safety device for mounting to a drug delivery device having a barrel containing a flange at a proximal end thereof and an injection needle at a distal end thereof, 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 and maintaining the collar and the sleeve axially spaced apart, the flexible member configured to effect elastic deformation of stored energy when the collar is pushed toward the sleeve and release the energy when a locking member of the sleeve is 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 comprises at least one elastic blade connecting the sleeve and the collar.

-The collar comprises at least one collar hook member configured to lock onto the piston flange, the collar hook member axially protruding in a cantilever manner from the collar in a proximal direction, the hook member having an inclined ramp surface at its free end.

The collar comprises two collar hook members 180 ° apart.

-The collar comprises at least one finger member cantilevered from the collar in a distal direction, the finger member having inclined proximal and distal ramp surfaces, the ramp surfaces being radially oriented in an inward direction and forming a generally triangular shape.

The collar comprises two finger members 180 ° apart.

-The sleeve comprises at least one leg extending in cantilever fashion from the sleeve towards the collar, the at least one leg having a leg hook member configured to hook onto the barrel flange.

-The at least one leg comprises an inwardly facing U-shaped portion and an adjacent ramp ear.

-The sleeve comprises 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 by a single injection moulding process.

In another aspect, the invention relates to a drug delivery device having a cartridge comprising a flange at its proximal end and an injection needle at its distal end, and a piston rod comprising a piston flange, which piston flange is equipped with a safety device as disclosed above.

The piston flange may comprise two flat portions alternating with two circular ears.

Drawings

The following is a more detailed description of aspects and embodiments of the invention, referenced by way of example, with reference to the accompanying drawings.

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

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

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

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

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

Detailed Description

The various features of the embodiments may be combined with each other and used together with other embodiments as long as the combined components do not interfere or interfere with the operation of the device and assembly. The 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 modification, practice or implementation 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 meant to encompass the items listed thereafter and equivalents thereof as well as additional items. Unless limited otherwise, the terms "connected," "coupled," "mounted," and variants thereof are used broadly herein and encompass both direct and indirect connections, couplings, and mountings. In addition, the terms "connected" and "coupled" and variations thereof are not restricted to physical or mechanical connections or couplings. Further, terms such as distal, proximal, upper, lower, bottom, and top are relative and are intended to aid in illustration and not limitation. The embodiments are not mutually exclusive and thus features of one embodiment may be combined with other embodiments so long as they are not mutually contradictory. Those skilled in the art will appreciate that terms of extent such as "substantially", "about" and "approximately" refer to and encompass a reasonable range of values around and beyond a given value, e.g., the general tolerances associated with the manufacture, assembly and use of the embodiments. When referring to a structure or feature, the term "substantially" includes the feature as it exists mostly or entirely within the structure.

Drug delivery device 100 may be a prefilled or prefillable syringe. The drug delivery device 100 comprises a tubular cartridge 102 defining a reservoir for containing a medical product such as a drug. The tubular barrel 102 may be made of plastic or glass material. The tubular barrel 102 has a distal shoulder 103 provided with a distal tip 104 protruding longitudinally from the distal 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 an injection needle 101 for injecting a medical product into an injection site. The tubular barrel 102 further comprises an opposite open proximal end provided with a flange 107. In some embodiments, the flange 107 may include two flat portions 108 alternating with two circular ears 109.

The open proximal end receives a plunger rod 110 for pushing a stopper 112 located inside the tubular barrel 102 to expel the medical product from the reservoir to the injection site via the distal tip 104 and the injection needle 101. Plunger rod 110 is provided with a plunger flange 114 upon which a user may place a thumb.

The drug delivery device 100 may be equipped with an end cap 113 for protecting and sealing the injection needle 101 prior to injection.

Turning to fig. 6 to 9, the safety device 10 comprises a collar 2 at its proximal end and a sleeve 3 at its distal end. The collar 2 and sleeve 3 are connected by flexible members which store mechanical energy when they are biased under load and release mechanical energy when the load is removed. In some embodiments, two blades 4 connect the collar 2 and the sleeve 3.

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

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

The sleeve 3 is configured and dimensioned to engage the barrel 102. In some embodiments, the sleeve 3 comprises two legs 6 extending in a cantilevered manner from the sleeve 3 towards the collar 2. In other embodiments not shown, the safety device may comprise two or more legs, such as three or four legs. The legs 6 can be elastically bent in a radial direction with respect to the sleeve 3.

At their free ends, each leg 6 comprises a leg hook member 7 comprising an inwardly facing U-shaped portion 8 and a ramp ear 9. The U-shaped portion 8 forms a groove configured and dimensioned to engage into the flange 107.

In some embodiments, the legs 6 and blades 4 are paired in pairs symmetrically with respect to the a axis. In some embodiments, as shown in fig. 10, the legs 6 and blades 4 are arranged side by side at an angle α between 25 ° and 45 °. Thus, the two pairs of legs 6 and blades 4 define two large lateral openings.

Collar 2 is a hollow circular member having a central opening configured and dimensioned to receive barrel 102 and flange 107.

As shown in fig. 8 and 9, the collar 2 comprises two collar hook members 11 and two opposing finger members 12.

Each collar hook member 11 comprises a tab 14 which projects axially in a cantilever manner from the collar 2 in the proximal direction. The ends of the tabs 14 include inclined ramp surfaces 15 oriented radially in an inward direction.

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

Each finger member 12 comprises a tab 17, which tab 17 projects axially in a cantilever manner from the collar 2 in the proximal direction. The ends of the tab 17 include two inclined proximal and distal ramp surfaces 18, 19 oriented radially in an inward direction, which form a generally triangular shape. Two finger members 12 are positioned angularly on collar 2 to be axially aligned with legs 6.

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

It will be appreciated that in some embodiments, the security device 10 is a one-piece component that can be manufactured by a single injection molding process, which will speed production. Thus, the safety device may be made of a single material to facilitate recycling of the device.

To assemble the safety device 10 to a drug delivery device, such as drug delivery device 100, which may be a pre-filled syringe, the distal end of drug delivery device 100 is engaged into collar 2, and sleeve 3 guides barrel 102. When the end of the drug delivery device 100 is pushed into the safety device 10, the flange 107 locks into the leg hook member 7, so that the safety device 10 is axially retained to the barrel 102. In some embodiments, the flange flat portion 108 locks into the U-shaped portion 8 of the leg hook member 7.

At the same time, the piston flange 114 abuts against the collar hook member 11. The piston flange 114 slides over the inclined ramp surface 12 of each collar hook member, which is deflected 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 by (i) its flange 107, which is locked to the leg hook member 7, and (ii) its piston flange 114, which is locked to the collar hook member 11.

In this state shown in fig. 1 and 2, the drug delivery device 100 equipped with the safety device 10 may be stored for future use. It can be noted that the safety device is not stressed and therefore long-term storage does not affect its performance.

When injecting the drug contained in drug delivery device 100, the user may first remove end cap 113.

Drug delivery device 100 is ready for injection. The user can visually inspect the medicament through the openings defined by the two pairs of legs 6 and blades 4.

Injection using a syringe equipped with the safety device 10 is substantially the same as injection using a syringe equipped with a safety device according to the prior art, and thus is less likely to confuse the user and allows a user-friendly operation.

In the exemplary use illustrated in fig. 1-5, a user may typically press a thumb against piston rod flange 114 while the user places one finger (typically the index finger) on one circular ear 109 and one finger (typically the middle finger) on the other circular ear 109 to apply a pushing force to piston rod flange 114.

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

With collar 2 locked to piston rod flange 114 and flange 107 locked to the leg, blade 4 is biased in a radially outward direction as shown in fig. 7 and stores mechanical energy.

At the end of the injection, the finger members 12 abut against the inclined ramp surfaces 9 of the leg hook members 8. By additional pushing of the piston rod 114, the inclined distal ramp surface 19 of the finger 12 abuts the ramp ear 9 provided at the end of the leg hook member 7. Thus, the leg hook member 7 is forced to deflect outwardly, releasing the flange 107. The blades 6 are free to release their mechanical energy and push the sleeve 3 axially in the distal direction. The needle 101 is then surrounded by the sleeve 3 and protected.

At the same time, flange 107 locks into distal ramped surface 19 of finger member 12.

The protection device 10 thus achieves a substantially permanent locking of the tubular body 12 on the needle tip 101 without any input by the user, since the blade 4 obtains mechanical energy during injection, which is used to move the safety device 10 to a safety position in which 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 present 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" and/or "comprising," 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 element. 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 one element's relationship to another element as illustrated in the figures. It should be understood that these terms, and those terms discussed above, are intended to encompass different orientations of the device in addition to the orientation depicted in the figures. It will 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 defined otherwise, 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 that is consistent with their meaning in the context of this specification and the relevant art and should 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, but, on the contrary, it will be recognized by those skilled in the art that variations and modifications may be made within the scope of the appended claims.

Claims

1. A safety device (10) for mounting on a drug delivery device (100), the drug delivery device having a barrel (102) and a piston rod (110), the barrel comprising a flange (107) at its proximal end and an injection needle (101) at its distal end, the piston rod 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), the sleeve being configured to slide on the barrel (102), the sleeve (3) having at least one locking member, the at least one locking member of the sleeve being 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 storing energy when the collar (2) is pushed toward the sleeve (3) and to release the energy when the sleeve is unlocked from the barrel,

The locking member of the sleeve comprises at least one leg (6) extending in a cantilevered manner from the sleeve (3) towards the collar (2), the at least one leg (6) having a leg hook member (7) configured to hook onto the flange (107) of the barrel, the leg hook member being operable to unlock the sleeve (3) from the barrel (102) so as to release energy stored in the flexible member when the sleeve (3) is unlocked from the barrel (102).

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

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

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

5. A safety device according to any one of claims 1 to 4, wherein the collar (2) comprises at least one finger member (12) projecting in a cantilevered manner from the collar (2) in a distal direction, the finger member (12) having inclined proximal and distal ramp surfaces (18, 19) which are radially oriented in an inward direction and substantially form a triangle.

6. A safety device according to claim 5, wherein the collar (2) comprises 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) comprises an inwardly facing U-shaped portion (8) and an adjacent ramp ear (9).

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

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

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

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

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