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CN-121985974-A - Reusable safety device, injection device comprising such a reusable safety device and method for resetting a reusable safety device

CN121985974ACN 121985974 ACN121985974 ACN 121985974ACN-121985974-A

Abstract

The safety device (1) comprises a bottom housing (4) extending along a longitudinal axis A and configured for accommodating a medical container (2) provided with an injection needle (21), a top housing (5) configured to be connected to the bottom housing (4) for axially blocking the medical container (2) within the bottom housing (4), a needle shield (3) movable relative to the bottom housing (4) between an initial position, a retracted position proximal relative to the initial position, and a safety position distal relative to the retracted position, in which safety position a proximal abutment surface (356) of the needle shield (3) abuts against a blocking member (43) of the bottom housing (4) such that the needle shield (3) cannot be moved back in a proximal direction, and a reset means (338 b, 351) configured to allow the proximal abutment surface (356) and the blocking member (43) to disengage such that the needle shield (3) can be moved from the safety position to the initial position.

Inventors

  • N. Besson
  • F. Carell
  • ALVAIN OLIVIER

Assignees

  • 贝克顿迪金森法国公司

Dates

Publication Date
20260505
Application Date
20240906
Priority Date
20230907

Claims (13)

  1. 1. A safety device (1) configured for preventing needle sticks, the safety device (1) comprising: a bottom housing (4) extending along a longitudinal axis a and configured for housing a medical container (2) provided with an injection needle (21); a top housing (5) configured to be connected to the bottom housing (4) so as to axially block the medical container (2) within the bottom housing (4), A fastener (45,54) configured to allow the bottom housing (4) to be removably attached to the top housing (5) so that the medical container (2) can be removed, -A needle shield (3) movable relative to the bottom housing (4) between an initial position, a retracted position proximal relative to the initial position, and a safety position distal relative to the retracted position, in which safety position a proximal abutment surface (356) of the needle shield (3) abuts against a blocking member (43) of the bottom housing (4) such that the needle shield (3) cannot be moved back in the proximal direction, A guide pin (41) configured for engaging a guide track (33) for guiding an axial and rotational movement of the needle shield (3) from the initial position to the safety position, -A resetting means (338 b, 351) configured for allowing the proximal abutment surface (356) and the blocking member (43) to disengage and for allowing the guide pin (41) to move back from the safety position to the initial position after removal of the medical container (2).
  2. 2. Safety device (1) according to the preceding claim, wherein the top housing (5) comprises a temporary blocking member (55), the temporary blocking member (55) being radially movable between a blocking position in which the temporary blocking member (55) abuts distally against the bottom housing (4) such that the top housing (5) cannot move distally relative to the bottom housing (4), and a release position in which the temporary blocking member (55) no longer abuts axially against the bottom housing (4) such that the top housing (5) can move distally relative to the bottom housing (4).
  3. 3. The safety device (1) according to the preceding claim, wherein the needle shield (3) comprises an injection triggering member (39), the injection triggering member (39) being configured for abutment against the temporary blocking member (55) of the top housing (5) such that the temporary blocking member (55) moves to the release position.
  4. 4. The safety device (1) according to any one of the preceding claims, wherein the plunger rod (53) is fixed to the top housing (5).
  5. 5. The safety device (1) according to any one of the preceding claims, wherein the top housing (5) comprises an axially movable distal abutment surface (512) configured for axially abutting against a flange (23) of the medical container (2), and biasing means configured for pressing the distal abutment surface (512) of the top housing (5) against the flange (23) of the medical container (2).
  6. 6. The safety device (1) according to any one of the preceding claims, wherein the bottom housing (4) comprises a proximal abutment surface (42) configured for axial abutment against a flange (23) of the medical container (2) and a distal abutment surface (414) configured for axial abutment against an injection depth defining member (339) of the needle shield (3).
  7. 7. The safety device (1) according to any one of the preceding claims, wherein the top housing (5) is removably attached to the bottom housing (4).
  8. 8. The safety device (1) according to any one of the preceding claims, wherein the bottom housing (4) comprises an elastically deformable fastener (45) for attaching the bottom housing (4) to the top housing (5), and the elastically deformable fastener (45) comprises an outer pressing portion (456) allowing a user to deform the elastically deformable fastener (45) radially inwards from a blocking position, in which the elastically deformable fastener (45) prevents removal of the top housing (5) from the bottom housing (4), to a release position, in which the top housing (5) is removable from the bottom housing (4).
  9. 9. The safety device (1) according to any one of the preceding claims, wherein the reset means comprises a reset portion (338 b) of the guide track (33) engaged by a guide pin (41), the reset portion (338 b) being configured for guiding the needle shield (3) from the safety position to the initial position by rotation of the needle shield (3) relative to the bottom housing (4) about a longitudinal axis a without requiring a back movement of the needle shield (3) relative to the bottom housing (4) in a proximal direction.
  10. 10. The safety device (1) according to any one of the preceding claims 1 to 8, wherein the reset means comprises a resilient leg (351), the resilient leg (351) comprising a proximal abutment surface (356) of the needle shield (3), the resilient leg (351) being radially deformable between a blocking position, in which the proximal abutment surface (356) abuts against a blocking member (43) of the bottom housing (4), and a release position, located radially inwards with respect to the blocking position, in which the proximal abutment surface (356) is displaced away from the blocking member (43), such that the needle shield (3) is movable back in the proximal direction from the safety position to the retracted position.
  11. 11. The safety device (1) according to any one of the preceding claims, wherein the safety device (1) comprises a cap (6) removably attached to a distal end (31) of the needle shield (3), the cap (6) comprising a remover (65), the remover (65) being configured for removing a needle shield (22) of the medical container (2).
  12. 12. An injection device (10) comprising a safety device (1) according to any of the preceding claims, and a medical container (2) arranged within a housing (4) of the safety device (1).
  13. 13. A method for resetting a safety device (1) according to any one of the preceding claims 1 to 11, the method comprising the steps of: -removing the medical container (2) from the bottom housing (4); -moving the needle shield (3) from the safety position to the initial position.

Description

Reusable safety device, injection device comprising such a reusable safety device and method for resetting a reusable safety device Technical Field The present invention relates to a reusable safety device and an injection device comprising the reusable safety device. The invention also relates to a method for assembling a reusable safety device to an injection device. Background In the present application, the distal end of a component or device is understood to mean the end furthest from the user's hand, and the proximal end is understood to mean the end closest to the user's hand. Also, in the present application, "distal direction" is understood to mean the direction away from the user's hand, while "proximal direction" is understood to mean the direction towards the user's hand. Some injection devices comprise a syringe provided with an injection needle and a safety device mounted around the syringe, the safety device comprising a needle shield which extends in a safe position after injection to protect a user from needle stick injuries. Typically, after injection, the syringe is discarded in a sharps container along with a safety device that is locked in a safe position. A new syringe equipped with another safety device is required to perform another injection operation. That is, each injection operation requires the use of a new safety device. From the document AU2012342450 an automatic injector is known which comprises a housing, a drive carriage arranged in the housing and a plunger coupled to the drive carriage. A method for assembling a cartridge for use in an automatic injector is known from document US 2023158252. Document GB2506918 discloses an automatic injector comprising heating means for heating the contents of the injector prior to injection. Document US2013245561 discloses a medical device for delivering at least two medicaments from separate reservoirs using an automatic injection device comprising a dose setting mechanism and a single dispense interface. Accordingly, there is a need for a security device that provides improved sustainability. Disclosure of Invention One aspect of the invention is a safety device configured to prevent needle sticks, the safety device comprising: A bottom housing extending along a longitudinal axis a and configured for housing a medical container provided with an injection needle; A top housing configured to be coupled to the bottom housing for axially blocking the medical container within the bottom housing, A needle shield movable relative to the base housing between an initial position, a retracted position proximal to the initial position, and a safety position distal to the retracted position, in which a proximal abutment surface of the needle shield abuts the blocking member of the base housing such that the needle shield cannot be moved back in a proximal direction, A reset tool configured to allow the proximal abutment surface and the blocking member to disengage such that the needle shield is movable from the safety position to the initial position. Thus, the safety device of the present invention can be reused. The safety device of the present invention thus improves sustainability, as only used medical containers are discarded. Once reset, the safety device of the present invention may receive a new (as yet unused) medical container to allow the user to safely perform another injection procedure. The safety device may include fasteners for allowing the bottom housing to be removably attached to the top housing such that the bottom housing and the top housing may be detached to allow removal of the medical container after injection. The reset tool may comprise a guide pin that is engaged within the guide track to guide axial and rotational movement of the needle shield from the initial position to the safety position, the reset tool being configured to allow disengagement of the proximal abutment surface and the blocking member and movement of the guide pin from the safety position back to the initial position after removal of the medical container. In an embodiment, the top housing comprises a temporary blocking member radially movable between a blocking position in which the temporary blocking member abuts distally against the bottom housing such that the top housing cannot move distally relative to the bottom housing, and a release position in which the temporary blocking member no longer abuts axially against the bottom housing such that the top housing can move in a distal direction relative to the bottom housing. In an embodiment, the needle shield comprises an injection triggering member configured for abutment against the temporary blocking member of the top housing such that the temporary blocking member moves to the release position. In one embodiment, the plunger rod is fixed to the top housing. In an embodiment, the top housing comprises an axially movable distal abutment surface configured for axial abutment against the flange of t