US-12623030-B2 - Standalone safety device for a needle of a medical device

US12623030B2US 12623030 B2US12623030 B2US 12623030B2US-12623030-B2

Abstract

A standalone safety device for a needle of a medical device A safety device for a needle of a medical device, the safety device including: a ring fixed with regard to the needle, a shield mounted on the ring by a pivot link, a protective cap covering at least partially the needle in an initial configuration, a translation locking unit adapted to prevent a translation movement of the protective cap, and a rotation locking unit adapted to prevent a rotation movement of the shield with regard to the ring. The translation locking unit is configured to be disengaged by the application of a predetermined translation force on the protective cap. The rotation locking unit is configured to be disengaged during a portion of the translation movement of the protective cap with regard to the shield.

Inventors

Franck Carrel
Olivier Alvain
Gregory Peruzzo

Assignees

BECTON DICKINSON FRANCE

Dates

Publication Date: 20260512
Application Date: 20210622
Priority Date: 20200623

Claims (13)

1 . A safety device for a needle of a medical device, the safety device comprising: a ring arranged to be fixed with regard to the needle a shield mounted on the ring by a pivot link so as to cover at least partially the needle in an initial configuration of the safety device and to give access to the needle in an operating configuration of the safety device a protective cap configured to cover at least partially the needle in the initial configuration a translation locking unit adapted to engage the protective cap and the shield to prevent a translation movement of the protective cap with regard to the ring and the shield, below a predetermined translation force a rotation locking unit adapted to further engage the protective cap and the shield to prevent a rotation movement of the shield with regard to the ring wherein: the translation locking unit comprises: at least one shield protrusion provided on the shield at least one cap protrusion provided on the protective cap and located proximally from the shield protrusion so as to prevent the distal movement of the protective cap in the initial configuration by abutting on the shield protrusion, at least part of one of the protective cap and/or of the shield is deformable under the predetermined translation force so that the cap protrusion can reach a distal side of the shield protrusion, the translation locking unit is configured to be disengaged by the application of the predetermined translation force on the protective cap, to allow a translation movement of the protective cap with regard to the ring and the shield, and the rotation locking unit is configured to be disengaged during a portion of the translation movement of the protective cap with regard to the shield.
2 . The safety device according to claim 1 , wherein the rotation locking unit comprises: at least one projection provided on one of the protective cap and the shield at least one rotation blocking abutment and at least one recess provided on the other of the protective cap and the shield wherein: in the initial configuration, the projection is configured to face the rotation blocking abutment and during the portion of the translation movement, the projection is configured to reach the at least one recess.
3 . The safety device according to claim 2 , wherein the one of the protective cap and the shield further comprises a leg pointing in a transversal direction, the leg comprising the projection.
4 . The safety device according to claim 3 , wherein the leg is flexible and the projection is pointing in another transversal direction, perpendicular to the distal direction and to the transversal direction.
5 . The safety device according to claim 2 , wherein the projection is a distal tong.
6 . The safety device according to claim 1 , wherein the protective cap and the shield comprise an opening unit adapted to move the shield from a closed position covering the needle to an open position giving access to the needle, during a subsequent portion of the translation movement of the protective cap.
7 . The safety device according to claim 6 , wherein 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.
8 . The safety device according to claim 1 , wherein the shield and the ring comprise a safety unit configured to lock the shield to the ring in a safety configuration of the safety device and in a safety position of the shield, in which the shield is adapted to permanently cover the needle.
9 . The safety device according to claim 8 , wherein the safety unit comprises at least one dead stop defined on the ring and at least one moving stop defined on a proximal portion of the shield and wherein the moving stop is configured to be on a first side of the dead stop in the open position of the shield and to move to a second side of the dead stop when the shield is rotated to the safety position.
10 . The safety device according to claim 1 , wherein the safety device further comprises a guiding unit configured to provide a sliding engagement between the ring and the protective cap.
11 . The safety device according to claim 1 , wherein the protective cap comprises a needle cap adapted to receive the needle, and wherein the protective cap comprises a recess adapted to receive at least part of the shield in the closed position.
12 . A safety needle hub adapted to be fixed on a medical device, the safety needle hub comprising a needle and a safety device according to claim 1 .
13 . A medical device adapted to inject and/or remove a fluid from a body, the medical device comprising a needle and a safety device according to claim 1 .

Description

CROSS-REFERENCE TO RELATED APPLICATIONS This application is the United States national phase of International Application No. PCT/EP2021/067042 filed Jun. 22, 2021, and claims priority to European Patent Application No. 20315316.8 filed Jun. 23, 2020, the disclosures of which are hereby incorporated by reference in their entirety. BACKGROUND OF THE INVENTION Field of the Invention The present invention relates to a standalone 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 medical care is performed. For example, document EP3302656 discloses such a safety device with a pivoting shield configured to pivot to an open position when a protective cap is removed from the needle and to cover the needle in a safety position thanks to a simple push on the shield, thus allowing a safe handling and disposal 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 syringe neck. There is thus a risk of unexpected opening of the safety device before use. In addition, such a safety device cannot be assembled before being mounted on a medical device which renders difficult its transportation and mounting to a medical device. 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 or disassembling and 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. 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 mounted on the ring by a pivot link so as to cover at least partially the needle in an initial configuration of the safety device and to give access to the needle in an operating configuration of the safety devicea protective cap configured to cover at least partially the needle in the initial configurationa translation locking unit adapted to engage the protective cap and the shield to prevent a translation movement of the protective cap with regard to the ring and the shield, below a predetermined translation forcea rotation locking unit adapted to further engage the protective cap and the shield to prevent a rotation movement of the shield with regard to the ring wherein: the translation locking unit is configured to be disengaged by the application of the predetermined translation force on the protective cap, to allow a translation movement of the protective cap with regard to the ring and the shield, and the rotation locking unit is configured to be disengaged during a portion of the translation movement of the protective cap with regard to the shield. The rotation locking unit may be configured to be locked as long as the translation locking unit is not disengaged. Consequently, the shield may be maintained in a close and/or stationary position, during the portion of the translation movement of the protective cap. A translation movement of the protective cap may thus be required, with a translation force above the predetermined translation force, before the disengagement of the rotation locking unit and a possible rotation movement of the shield with regard to the ring. Preferably, the rotation locking unit and the translation locking unit are different locking units, i.e. without any common structural feature. Thanks to the translation locking unit, the protective cap cannot be removed from the needle unintentionally. Further, the rotation locking unit also prevents any unintentional rotation of the shield with regard to the needle as long as the translation locking unit is activated or locked. The present safety device can thus be transported and handled safely, even if it is not mounted on a medical device. At the time of operating a medical device provided with such a safety device, it is only required to remove the protective cap from the needle with a translation force above the predetermined force to