Patent Description:
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 <CIT> 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. In addition, <CIT> relates to a safety needle assembly with pivoting shield.

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.

This objective is accomplished by a safety device for a needle of a medical device, the safety device comprising:.

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:.

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.

Further advantages and preferred embodiments of the present invention will become apparent from the following detailed description and drawings, in which:.

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.

Now referring to <FIG>, and from proximal to distal or from left to right in the view of <FIG>, a medical device under the form of a syringe <NUM> comprises a proximal flange <NUM>, a barrel <NUM>, a distal neck <NUM> and an embodiment of a safety device <NUM> comprising a ring <NUM>, a shield <NUM> and a protective cap <NUM>.

With reference to <FIG>, the ring <NUM> is mounted around the distal neck <NUM>, from which protrudes a needle <NUM> comprising a tip 14a. The ring <NUM> can comprise a knuckle <NUM> adapted to accommodate part the shield <NUM> in order to form a pivot link such as a hinge. Further, the ring <NUM> can comprise two side surfaces <NUM> located on two opposite sides of the ring <NUM> (only one visible in <FIG>). The side surfaces may each have a distal sloped surface <NUM> and a recess <NUM> located proximally to the distal sloped surface <NUM>.

Each of the recesses <NUM> can have a sloped distal side proximally from the distal sloped surface <NUM> (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 ring <NUM> is 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 ring <NUM> may include a central opening <NUM> located around the distal neck <NUM> and opened distally. For example, the central opening <NUM> can have a radial opening toward the side surfaces <NUM> and the distal sloped surfaces <NUM>. Finally, the ring <NUM> may further comprise two longitudinal slots <NUM>, located on opposite sides of the ring <NUM>, for example nearby or below the side surfaces <NUM>.

With reference to <FIG>, the shield <NUM> comprises a main surface <NUM> (the top surface of the shield <NUM> in <FIG>, the back surface of the shield <NUM> in <FIG>), a pivot <NUM> located at a proximal extremity of the main surface <NUM> and adapted to be received in the knuckle <NUM> of the ring <NUM> so as to form the pivot link. The shield <NUM> further includes on its proximal portion two flexible wings <NUM> extending from the main surface <NUM>, preferably located each on an opposite side of the pivot <NUM>. The flexible wings <NUM> may be integral with the shield <NUM> and can comprise a type of material and a thickness allowing a deformation, in particular in the transversal direction.

The flexible wings <NUM> each define at their proximal extremity a peg <NUM> defining a sliding surface 44a and a straight, transversal distal surface 44b intended to act as a stop. Each flexible wing <NUM> further defines a cam surface <NUM> extending proximally with regard to the pegs <NUM>.

In addition, the distal portion of the shield <NUM> (on the right in <FIG>) further comprises a shield recess <NUM> defined by two side walls <NUM> extending from the main surface <NUM>. The shield recess <NUM> has a substantially open distal end 46a which is partially closed by a transversal wall <NUM>. The shield <NUM> may also comprise a distal tong <NUM> extending from the distal extremity of the main surface <NUM>, further from the transversal wall <NUM>. The shield <NUM> can be made of the same material as the ring <NUM> and be preferably less rigid than the ring <NUM>, for example through the material thickness and/or composition.

With reference to <FIG>, the protective cap <NUM> comprises a main surface <NUM> which is substantially U-shaped in the distal portion <NUM> of the protective cap <NUM> (on the right in <FIG>) and hemi circular in the proximal portion <NUM> (on the left in <FIG>). The proximal extremity 53a of the proximal portion <NUM> is provided with two pushers <NUM> and two distal protrusions <NUM>.

The distal protrusions <NUM> are extending distally from the pusher <NUM> and each cover part of an edge 53b of the proximal portion <NUM>. The distal protrusions <NUM> each define a sloped or deflecting surface 54a facing an outside of the protective cap <NUM>. For example, the deflecting surface 54a has the same angle as the sliding surface 44a of the shield <NUM>. The pushers <NUM> extend circumferentially from the edge 53b of the proximal portion <NUM> and may have a curved shape similar or complementary to the shape of the cam surface <NUM> of the shield <NUM>.

The proximal portion further comprises two longitudinal ribs <NUM> extending on the opposite sides of the proximal portion <NUM> and on the inside of the main surface <NUM>, for example below and parallel to the distal protrusions <NUM>. The distal portion <NUM> of the protective cap <NUM> comprises a cap opening <NUM>, at the top of the "U" shape and a longitudinal opening <NUM> optionally provided at the circular distal extremity 52a of the distal portion <NUM>. Notches 51a and/or protrusions can be provided on the sides of the main surface <NUM>, to facilitate grasping. The protective cap <NUM> can comprise the same material as the ring <NUM>.

A needle cap <NUM> may be accommodated inside the protective cap <NUM> and is maintained for example by friction with the internal side of the main surface <NUM> and with an arch <NUM> of the protective cap <NUM>. The needle cap <NUM> is thus intended to be fixed with regard to the protective cap <NUM> and may also be glued to the protective cap <NUM> or the protective cap <NUM> can be overmolded on the needle cap <NUM>. The needle cap <NUM> is intended to accommodate the needle <NUM> during the storage time of the syringe <NUM> and thus only comprises a single proximal opening <NUM> and a proximal edge <NUM> intended to contact the distal neck <NUM> in the initial configuration. The needle cap <NUM> can comprise elastomeric polymer or elastomer such as natural rubber, butyl rubber or silicon rubber.

When the safety device <NUM> is assembled on the syringe <NUM>, as shown in <FIG> and <FIG>, the needle <NUM> is accommodated into the needle cap <NUM> which is inserted in the central opening <NUM> of the ring <NUM> and contacts the distal neck <NUM> of the syringe <NUM> in order to maintain the needle <NUM> protected from dust and microorganisms. The needle cap <NUM> is accommodated in the protective cap <NUM>, which partially surrounds the ring <NUM> and the longitudinal ribs <NUM> of the protective cap <NUM> are engaged into the longitudinal slots <NUM> of the ring <NUM>.

The shield <NUM> may be partially accommodated into the protective cap <NUM>: the flexible wings <NUM> of the shield <NUM> may contact the edge 53b of the protective cap <NUM>, the two side walls <NUM> of the shield <NUM> are accommodated into the cap opening <NUM> of the protective cap <NUM> and the needle cap <NUM> is partially accommodated in the shield recess <NUM> of the shield <NUM>. The distal tong <NUM> of the shield <NUM> is accommodated into the longitudinal opening <NUM> of the protective cap <NUM> (not visible in <FIG>) which allows to maintain the shield <NUM> fixed with regard to the protective cap <NUM> even when the safety device <NUM> is not assembled to a medical device. The distal tong <NUM> and the longitudinal opening <NUM> may thus act as an assembly unit.

Further, the shield <NUM> is assembled to the ring <NUM> by the pivot <NUM>, which is in a pivot engagement with the knuckle <NUM> and locked to the ring <NUM> by the engagement of the pegs <NUM> into the recesses <NUM>: in this closed position visible in <FIG> and <FIG>, any rotation of the shield <NUM> with regard to the ring <NUM> is prevented. In particular, the distal surface 44b of the pegs <NUM> can contact or abut the sloped distal side of the recess <NUM> and the shield <NUM> cannot rotate toward the open position. The pegs <NUM> and the side surfaces <NUM> thus act as a locking unit.

During storage time, the syringe can be provided into a blister with the safety device in the initial configuration of <FIG> and <FIG>: the shield <NUM> is in the closed position, locked to the ring <NUM> and the protective cap <NUM> is fixed to the shield <NUM> and accommodates the needle <NUM>. At the time of being used, a user must first remove the protective cap <NUM> from the distal neck <NUM> in order to reveal the needle <NUM>, as usual. To that end, the user can grip the main surface <NUM> of the cap with his/her fingers, for example on the notches 51a, and move the protective cap <NUM> in the distal direction (on the right of the figures).

Thanks to the engagement between the longitudinal slots <NUM> of the ring <NUM> and the longitudinal ribs <NUM> of the protective cap <NUM>, only a linear movement in the distal direction of the protective cap is possible and the longitudinal slots <NUM> and the longitudinal ribs <NUM> thus acts as a guiding unit establishing a sliding engagement or prismatic joint between the ring <NUM> and the protective cap <NUM> and the removal movement of the protective cap <NUM> is thus limited to a linear movement in the distal direction.

During the removal movement of the protective cap <NUM> from the ring <NUM> and the needle <NUM>, 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 to <FIG>, the protective cap <NUM> is moved distally (see the white arrows in <FIG>) and the shield <NUM> remains in the closed position of <FIG>, in particular thanks to the engagement of the pegs <NUM> of the shield <NUM> into the recesses <NUM> of the ring <NUM> and the preferential engagement of the distal tong <NUM> into the longitudinal opening <NUM>.

In this portion of the removal movement of the protective cap <NUM>, the distal protrusions <NUM> move distally and come in contact with the pegs <NUM>. As the removal movement of the protective cap <NUM> is maintained, the deflecting surfaces 54a of the distal protrusions <NUM> slide against the respective sliding surface 44a of the pegs <NUM> and deflect outwardly the flexible wings <NUM> of the shield. Consequently, the flexible wings <NUM> and optionally the sliding surface 44a form with the distal protrusion <NUM> and the deflecting surface 54a a releasing unit configured to release or disengage the locking unit when the protective cap <NUM> is removed from the needle <NUM>.

After the release of the locking unit, the shield <NUM> is free to rotate with regard to the ring <NUM>: during the subsequent portion of the removal movement of the protective cap <NUM>, the pushers <NUM> come in contact with the cam surfaces <NUM> of the shield <NUM> (see <FIG>). The cam surfaces <NUM> are pushed by the pushers <NUM>, which rotates the shield <NUM> toward the proximal direction (see the black arrow in <FIG>) from the closed position to an open position visible in <FIG>.

At the end of the subsequent portion of the removal movement of the protective cap <NUM>, the shield may have rotated proximally for example of at least <NUM>° and preferably <NUM> or <NUM>° with regard to its closed position: the safety device <NUM> is now in an operating configuration, the needle <NUM> is now accessible and can be used to prick the patient's body and a medicine can be injected thanks to the syringe <NUM>.

After the injection operation has been performed, the shield <NUM> can be rotated back toward the needle <NUM>. For example, the user can press distally the main surface <NUM> of the shield <NUM> (see the white arrow in <FIG>) and the shield <NUM> can rotate toward the distal direction (see the black arrow in <FIG>).

The locking unit can then be locked again thanks by an addition force applied on the main surface <NUM> of the shield <NUM> and the flexible wings <NUM> may be deflected thanks to the contact between the sliding surfaces 44a of the pegs <NUM> and the distal sloped surfaces <NUM> of the ring <NUM>. The pegs <NUM> finally engage the recesses <NUM> similarly to the initial position of <FIG> and the shield <NUM> is then in a closed position, covering the needle <NUM> and preventing any needle stick injury.

In the final configuration of <FIG>, the shield <NUM> is in the same closed position as in the initial configuration of <FIG> and <FIG>. 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 device <NUM>. 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.

Claim 1:
A safety device (<NUM>) for a needle (<NUM>) of a medical device, the safety device (<NUM>) comprising:
• a ring (<NUM>) arranged to be fixed with regard to the needle (<NUM>)
• a shield (<NUM>) arranged to be mounted on the ring (<NUM>) by a pivot link so as to define a closed position in which the shield (<NUM>) covers the needle (<NUM>) and an open position in which the shield (<NUM>) does not cover the needle (<NUM>)
• a protective cap (<NUM>) configured to surround the needle (<NUM>) and to accommodate at least part of the shield (<NUM>) in the closed position
characterized in that the ring (<NUM>) and the shield (<NUM>) further comprise a locking unit adapted to lock the shield (<NUM>) to the ring (<NUM>) in the closed position, and
in that the protective cap (<NUM>) and the shield (<NUM>) comprise a releasing unit adapted to release the locking unit during a portion of a removal movement of the protective cap (<NUM>).