A Safety Device for a Needle of a Medical Device

A safety device for a needle of a medical device is provided. The safety device includes: a ring arranged to be fixed with regard to the needle, a shield arranged to be mounted on the ring by a pivot link so as to define a closed position in which the shield covers the needle and an open position, and a protective cap configured to surround the needle and to accommodate at least part of the shield in the closed position. The ring and the shield further include a locking unit adapted to lock the shield to the ring in the closed position. The protective cap and the shield include a releasing unit adapted to release the locking unit during a portion of a removal movement of the protective cap.

BACKGROUND OF THE INVENTION

Field of the Invention

The present invention relates to a safety device for a needle of a medical device, a safety needle hub and a medical device comprising such a safety device.

Description of Related Art

A wide number of medical devices rely on a needle in order to prick a patient's skin and to deliver a medicine or to collect a body fluid. In particular, syringes are a common way of delivering drugs or vaccines to patients and usually comprise an injection needle to deliver such drugs into a patient's skin or a patient's muscle. However, needles present a sharp tip with a risk of needle stick injury, in particular for the medical staff, and it is highly desirable to prevent such needle stick injuries for safety reasons.

Consequently, safety devices have been proposed in order to cover the needle when the needle is not to be used and to allow access to the needle when a medical operation is performed. For example, document EP3302656 discloses such a safety device with a pivoting shield that pivot to an open position when a protective cap is removed from the needle and covers the needle in a closed position thanks to a simple push on the shield, thus allowing a safe handling and disposable of the syringe after use.

However, the shield of such a prior art safety device is not locked in the initial position and the protective cap is only maintained by friction on the needle. There is thus a risk of unexpected opening of the safety device before use. In addition, such a prior art safety device relies on a hook to be locked to the needle in a final position. This hook must be accommodated in the protective cap in order to keep the safety device small, but this may decrease the protection and sterility of the needle before use.

There is thus a need for a safety device overcoming these drawbacks. In other words, there is a need for a safety device preventing any unexpected opening while maintaining a high level of protection and sterility of the needle before use. In addition, such a safety device must remain small, to limit storage space as well as convenient and safe to use, in particular with gloves and during emergency situations.

SUMMARY OF THE INVENTION

This objective is accomplished by a safety device for a needle of a medical device, the safety device comprising:a ring arranged to be fixed with regard to the needlea shield arranged to be mounted on the ring by a pivot link so as to define a closed position in which the shield covers the needle and an open position in which the shield does not cover the needlea protective cap configured to surround the needle and to accommodate at least part of the shield in the closed position
wherein the ring and the shield further comprise a locking unit adapted to lock the shield to the ring in the closed position, and
wherein the protective cap and the shield comprise a releasing unit adapted to release the locking unit during a portion of a removal movement of the protective cap.

Thanks to the locking unit, the protective cap cannot be moved to the open position unintentionally in the initial configuration of the safety device wherein the protective cap is present and the shield is in the closed position. Further, when the safety device is in a final configuration after use without the protective cap and with the shield in the closed position, the locking unit can lock the shield to the ring and no hook is thus required on the shield. Finally, the releasing unit releases the locking unit during the removal movement of the protective cap from the needle and/or from the safety device, which renders the present safety device efficient and straightforward to use.

Advantageously, the locking unit comprises:at least one recess provided on one of the ring and the shieldat least one peg provided on the other of the ring and the shieldwherein in the closed position, the peg is engaged into the recess.

This locking unit is simple to manufacture and provides a safe locking of the shield to the ring. Preferably, two pegs and two recesses are provided, for example on opposite sides of the shield and the ring, respectively. For example, the locking unit consists in one or two recesses provided on the ring and one or two pegs provided on the shield.

Advantageously, the releasing unit comprises a distal protrusion provided on the protective cap and defining a deflecting surface, and a flexible wing provided on the shield and comprising the peg, the deflecting surface being configured to deflect the flexible wing during the portion of the removal movement of the protective cap so as to disengage the peg from the recess.

These releasing unit allows for a straightforward and intuitive release of the locking member during the portion of the removal movement of the protective cap.

Preferably, the deflection of the flexible wing is performed in the transversal or outward direction. The flexible wing may comprise a sliding surface adapted for the deflecting surface to slide on it. For example, both the sliding surface and the deflecting surface may have the same slope. Such a sliding surface allows to decrease the force required to remove the protective cap from the safety device.

Advantageously, the protective cap and the shield comprise an opening unit adapted to move the shield from the closed position to the open position during a subsequent portion of the removal movement of the protective cap. This opening unit can thus perform a passive opening of the shield, without a direct operation of the shield by the user, which significantly increases the safety and the convenience of operating such a safety device.

Advantageously, the opening unit comprises a cam surface provided on the shield and a pusher provided on the protective cap, the pusher being configured to engage the cam surface during the subsequent portion of the removal movement of the protective cap. Preferably, the cam surface is located on the shield remotely from the pivot link so as to produce a lever effect.

This pushing unit is simple to manufacture and allows a reliable passive opening of the shield in the subsequent portion of the removal movement of the protective cap. Preferably, the cam surface is provided on the flexible wing, such as on a proximal edge of the flexible wing and for example proximally from the sliding surface and/or from the peg.

Advantageously, the safety device comprises a safety unit adapted to ease the engagement the locking unit when the shield is moved from the open position to the closed position. Consequently, the shield can be blocked permanently in the closed position covering the needle in the final configuration thanks to a limited force applied on the shield, therefore allowing a convenient handling and a safe disposal of the safety device.

Advantageously, the safety unit comprises the flexible wing of the shield and a distal sloped surface provided on the ring adapted to deflect the flexible wing when the shield is moved from the open position to the closed position. For example, the peg can engage the recess once again with a limited force. Preferably, the safety unit also comprises the sliding surface of the flexible wing. Such a safety unit is simple to manufacture and only requires a limited force for re-engaging the locking unit in the final configuration.

Advantageously, the protective cap and the shield further comprise an assembly unit adapted to fasten or attach the shield to the protective cap, when the shield is in the closed position and/or the safety device is in the initial configuration. Such an assembly unit contributes to prevent any movement of the shield as long as the protective cap is not removed and also allows to assemble the safety device before the safety device is mounted on a medical device.

Advantageously, the assembly unit comprises a distal tong provided on one of the shield and the protective cap and a longitudinal opening provided on the other of the shield and the protective cap, wherein the distal tong is accommodated into the longitudinal opening before the protective cap is removed from the shield, i.e. in the initial configuration of the shield. This assembly unit is easy to manufacture and to assemble.

Advantageously, the safety device further comprises a guiding unit configured to provide a sliding engagement between the ring and the protective cap. Such a guiding unit can prevent any undesired movement of the protective cap during the removal movement of the shield and for example establishes a prismatic joint between the ring and the protective cap. Preferably, the guiding unit comprises a longitudinal slot on one of the ring and the protective cap and a longitudinal rib on the other of the ring and the protective cap, preferably on the protective cap.

Advantageously, the ring has an edge or circumference and the pivot link is provided on a portion of the circumference, which allows for an easy assembly of the shield to the ring and a reliable rotation of the shield.

Advantageously, the locking unit comprise two recesses provided on two opposite portions of the circumference of the ring, which provide a safe engagement of the locking unit. Consequently, the shield may also comprise two opposite flexible wings each provided with a peg.

Preferably, the recesses are provided on a different portion of the circumference of the ring than the pivot link. For example, the ring comprises opposite side surfaces and the recesses are provided on theses side surfaces.

Advantageously, the protective cap comprises a needle cap adapted to receive the needle, and the protective cap comprises a cap opening adapted to receive at least part of the shield in the closed position. This allows to reduce the volume of the safety device and thus not to change storage and transportation practice. Preferably, the needle cap has a single proximal opening adapter to receive the needle and for example, part of a distal neck of the medical device. Consequently, the needle cap may not comprise any opening to receive the shield or part of the shield.

Preferably, the protective cap is adapted to fully accommodate the shield. For example, the protective cap defines a diameter and the shield is comprised within said diameter in the initial configuration. For example, the diameter is a diameter of the ring and is equal or less than a diameter such as an external diameter of the medical device on which the present safety device is intended to be mounted.

A second aspect of the present invention is a safety needle hub adapted to be fixed on a medical device such as a syringe, the safety needle hub comprising a needle and a safety device according to the first aspect of the present invention.

A third aspect of the present invention is a medical device adapted to inject and/or remove a fluid from a body, comprising a needle and a safety device according to the first aspect of the present invention or a safety needle hub according to the second aspect of the present invention.

Advantageously, the shield comprises a longitudinal axis parallel to the needle in the closed position, which provides a compact and user-friendly safety needle hub or medical device.

DESCRIPTION OF THE INVENTION

The present safety device is intended to be used with or on any kind of injection, test or sampling medical device using a needle adapted to prick a patient's body for any kind of prophylactic, diagnosis, aesthetics or therapeutic medical treatment. For example, such a medical device can be a medical syringe or a blood collection tube. The safety device can be delivered mounted on the medical device or as a safety needle hub adapted to be fixed on a tip of the medical device. In addition, the safety device can also be proposed alone, for example for a subsequent mounting on a syringe or on a medical device, depending on the targeted customer.

The safety device according to the present invention is described in the examples of the appended figures as mounted on a syringe as a medical device. As such, in this application, the distal direction must be understood as the direction of injection with reference to the medical device, and the proximal direction is the opposite direction, i.e. the direction toward the hand of the medical caregiver or of the patient.

Description of the Main Embodiment

Now referring toFIG.1, and from proximal to distal or from left to right in the view ofFIG.1, a medical device under the form of a syringe10comprises a proximal flange12, a barrel11, a distal neck13and an embodiment of a safety device20comprising a ring30, a shield40and a protective cap50.

With reference toFIG.2, the ring30is mounted around the distal neck13, from which protrudes a needle14comprising a tip14a. The ring30can comprise a knuckle31adapted to accommodate part the shield40in order to form a pivot link such as a hinge. Further, the ring30can comprise two side surfaces32located on two opposite sides of the ring30(only one visible inFIG.2). The side surfaces may each have a distal sloped surface33and a recess34located proximally to the distal sloped surface33.

Each of the recesses34can have a sloped distal side proximally from the distal sloped surface33(on the right of the recess in the figures), for example pointing the distal direction, and a straight proximal side (on the left of the recess in the figures). The ring30is preferably made of hard, rigid material such as a hard polymer or composite adapted for medical use, such as high density polyethylene (PE), polypropylene (PP), polycarbonate (PC), acrylonitrile butadiene styrene (ABS), polyoxymethylene (POM), polystyrene (PS), polybutylene terephthalate (PBT), polyamide (PA), and their combinations.

The ring30may include a central opening35located around the distal neck13and opened distally. For example, the central opening35can have a radial opening toward the side surfaces32and the distal sloped surfaces33. Finally, the ring may further comprise two longitudinal slots36, located on opposite sides of the ring30, for example nearby or below the side surfaces32.

With reference toFIG.3, the shield40comprises a main surface41(the top surface of the shield40inFIG.1, the back surface of the shield40inFIG.3), a pivot42located at a proximal extremity of the main surface41and adapted to be received in the knuckle31of the ring30so as to form the pivot link. The shield40further includes on its proximal portion two flexible wings43extending from the main surface41, preferably located each on an opposite side of the pivot42. The flexible wings43may be integral with the shield40and can comprise a type of material and a thickness allowing a deformation, in particular in the transversal direction.

The flexible wings43each define at their proximal extremity a peg44defining a sliding surface44aand a straight, transversal distal surface44bintended to act as a stop. Each flexible wing43further defines a cam surface45extending proximally with regard to the pegs44.

In addition, the distal portion of the shield40(on the right inFIG.3) further comprises a shield recess46defined by two side walls47extending from the main surface41. The shield recess46has a substantially open distal end46awhich is partially closed by a transversal wall49. The shield40may also comprise a distal tong48extending from the distal extremity of the main surface41, further from the transversal wall49. The shield40can be made of the same material as the ring30and be preferably less rigid than the ring30, for example through the material thickness and/or composition.

With reference toFIG.4, the protective cap50comprises a main surface51which is substantially U-shaped in the distal portion52of the protective cap50(on the right inFIG.4) and hemi circular in the proximal portion53(on the left inFIG.4). The proximal extremity53aof the proximal portion53is provided with two pushers55and two distal protrusions54.

The distal protrusions54are extending distally from the pusher55and each cover part of an edge53bof the proximal portion53. The distal protrusions54each define a sloped or deflecting surface54afacing an outside of the protective cap50. For example, the deflecting surface54ahas the same angle as the sliding surface44aof the shield40. The pushers55extend circumferentially from the edge53bof the proximal portion53and may have a curved shape similar or complementary to the shape of the cam surface45of the shield40.

The proximal portion further comprises two longitudinal ribs56extending on the opposite sides of the proximal portion53and on the inside of the main surface51, for example below and parallel to the distal protrusions54. The distal portion52of the protective cap50comprises a cap opening57, at the top of the “U” shape and a longitudinal opening58optionally provided at the circular distal extremity52aof the distal portion52. Notches51aand/or protrusions can be provided on the sides of the main surface51, to facilitate grasping. The protective cap50can comprise the same material as the ring30.

A needle cap60may be accommodated inside the protective cap50and is maintained for example by friction with the internal side of the main surface51and with an arch59of the protective cap50. The needle cap60is thus intended to be fixed with regard to the protective cap50and may also be glued to the protective cap50or the protective cap50can be overmolded on the needle cap60. The needle cap60is intended to accommodate the needle14during the storage time of the syringe10and thus only comprises a single proximal opening61and a proximal edge62intended to contact the distal neck13in the initial configuration. The needle cap60can comprise elastomeric polymer or elastomer such as natural rubber, butyl rubber or silicon rubber.

When the safety device20is assembled on the syringe10, as shown inFIG.1andFIGS.5,6and7, the needle14is accommodated into the needle cap60which is inserted in the central opening35of the ring30and contacts the distal neck13of the syringe10in order to maintain the needle14protected from dust and microorganisms. The needle cap60is accommodated in the protective cap50, which partially surrounds the ring30and the longitudinal ribs56of the protective cap50are engaged into the longitudinal slots36of the ring30.

The shield40may be partially accommodated into the protective cap50: the flexible wings43of the shield40may contact the edge53bof the protective cap50, the two side walls47of the shield40are accommodated into the cap opening57of the protective cap50and the needle cap60is partially accommodated in the shield recess46of the shield40. The distal tong48of the shield40is accommodated into the longitudinal opening58of the protective cap50(not visible inFIGS.5-7) which allows to maintain the shield40fixed with regard to the protective cap50even when the safety device20is not assembled to a medical device. The distal tong48and the longitudinal opening58may thus act as an assembly unit.

Further, the shield40is assembled to the ring30by the pivot42, which is in a pivot engagement with the knuckle31and locked to the ring30by the engagement of the pegs44into the recesses34: in this closed position visible inFIGS.1and5to7, any rotation of the shield40with regard to the ring30is prevented. In particular, the distal surface44bof the pegs44can contact or abut the sloped distal side of the recess34and the shield40cannot rotate toward the open position. The pegs44and the side surfaces32thus act as a locking unit.

Operation of the Embodiment

During storage time, the syringe can be provided into a blister with the safety device in the initial configuration ofFIGS.1and5to7: the shield40is in the closed position, locked to the ring30and the protective cap50is fixed to the shield40and accommodates the needle14. At the time of being used, a user must first remove the protective cap50from the distal neck13in order to reveal the needle14, as usual. To that end, the user can grip the main surface51of the cap with his/her fingers, for example on the notches51a, and move the protective cap50in the distal direction (on the right of the figures).

Thanks to the engagement between the longitudinal slots36of the ring30and the longitudinal ribs56of the protective cap50, only a linear movement in the distal direction of the protective cap is possible and the longitudinal slots36and the longitudinal ribs56thus acts as a guiding unit establishing a sliding engagement or prismatic joint between the ring30and the protective cap50and the removal movement of the protective cap50is thus limited to a linear movement in the distal direction.

During the removal movement of the protective cap50from the ring30and the needle14, a portion of this movement results in the disengagement or release of the locking unit and a subsequent portion of this movement results in the rotation of the shield from the closed position to the open position.

With reference toFIGS.8to10, the protective cap50is moved distally (see the white arrows inFIGS.8and9) and the shield40remains in the closed position ofFIGS.5-7, in particular thanks to the engagement of the pegs44of the shield40into the recesses34of the ring30and the preferential engagement of the distal tong48into the longitudinal opening58.

In this portion of the removal movement of the protective cap50, the distal protrusions54move distally and come in contact with the pegs44. As the removal movement of the protective cap50is maintained, the deflecting surfaces54aof the distal protrusions54slide against the respective sliding surface44aof the pegs44and deflect outwardly the flexible wings43of the shield. Consequently, the flexible wings43and optionally the sliding surface44aform with the distal protrusion54and the deflecting surface54aa releasing unit configured to release or disengage the locking unit when the protective cap50is removed from the needle14.

After the release of the locking unit, the shield40is free to rotate with regard to the ring30: during the subsequent portion of the removal movement of the protective cap50, the pushers55come in contact with the cam surfaces45of the shield40(seeFIG.11). The cam surfaces45are pushed by the pushers55, which rotates the shield40toward the proximal direction (see the black arrow inFIG.11) from the closed position to an open position visible inFIG.12.

At the end of the subsequent portion of the removal movement of the protective cap50, the shield may have rotated proximally for example of at least 90° and preferably 120 or 140° with regard to its closed position: the safety device20is now in an operating configuration, the needle14is now accessible and can be used to prick the patient's body and a medicine can be injected thanks to the syringe10.

After the injection operation has been performed, the shield40can be rotated back toward the needle14. For example, the user can press distally the main surface41of the shield40(see the white arrow inFIG.12) and the shield40can rotate toward the distal direction (see the black arrow inFIG.12).

The locking unit can then be locked again thanks by an addition force applied on the main surface41of the shield40and the flexible wings43may be deflected thanks to the contact between the sliding surfaces44aof the pegs44and the distal sloped surfaces33of the ring30. The pegs44finally engage the recesses34similarly to the initial position ofFIGS.5to7and the shield40is then in a closed position, covering the needle14and preventing any needle stick injury.

In the final configuration ofFIG.13, the shield40is in the same closed position as in the initial configuration ofFIGS.1and5-7. Consequently, no direct engagement between the shield and the needle is required and the locking unit can be used both in the initial configuration and in the final configuration of the safety device20. This allows the safety device to prevent needle stick injuries in the final configuration, to be compact at the time of storage and disposal and to efficiently protect the needle in the initial configuration.

Although the present invention has been described and illustrated in detail, it is clearly understood that the same is by way of illustration and example only and is not to be taken by way of limitations, the scope of the present invention being limited only by the terms of the appended claims. For example, the elements of the safety device such as the pegs, the recesses, the pushers, etc. may have any shape or geometry as long as their function can be performed.