Safety device for a pre-filled syringe and injection device

Patent metadata

Field	Value
Publication number	US-9352099-B2
Application number	US-201113808084-A
Country	US
Kind code	B2
Filing date	Jun 21, 2011
Priority date	Jul 2, 2010
Publication date	May 31, 2016
Grant date	May 31, 2016

Abstract

According to the invention, a safety device for a pre-filled syringe comprises a hollow support body for mounting the pre-filled syringe therein, a hollow needle shield that is slidable relative to the support body and guiding means for guiding the movement of the needle shield relative to the support body. The guiding means comprise a flexible arm with a guide pin, a guide track and a separating wall. The guide pin extends from the flexible arm in a radial direction, and protrudes into the guide track. The separating wall extends into the guide track in a direction parallel to a central axis of the safety device. When the needle shield is slid relative to the support body the guide pin moves along the guide track to deflect the flexible arm in a lateral direction perpendicular to the central axis and the movement of the guide pin along the guide track is guided by the interplay of the flexible arm and the separating wall.

First claim

The invention claimed is:

1. A safety device for a pre-filled syringe comprising:
a hollow support body for mounting the pre-filled syringe therein, the pre-filled syringe comprising a hypodermic needle attached to a distal end of the pre-filled syringe,
a hollow needle shield that is slidable relative to the support body, the needle shield and the support body being configured such that relative rotation of the support body and the needle shield is inhibited, and
a guiding mechanism to guide movement of the needle shield relative to the support body, the guiding mechanism comprising:
a flexible arm,
a guide pin extending from the flexible arm in a radial direction,
a guide track, wherein the guide pin protrudes into the guide track, and
a separating wall that extends into the guide track in a direction parallel to a central axis of the safety device,
wherein, the guide pin is configured to move along the guide track to deflect the flexible arm in a lateral direction perpendicular to the central axis when the needle shield is slid relative to the support body,
wherein the guide pin is movable within the guide track from a start position through an intermediate position to an end position such that a distal end of the needle of the pre-filled syringe is surrounded by the needle shield when the guide pin is in the start position and the end position, and
wherein the flexible arm interacts with the separating wall to guide movement of the guide pin along the guide track.

2. The safety device according to claim 1 , wherein the flexible arm is connected to one of the needle shield and the support body, and the guide track is formed into the other of the needle shield and the support body.

3. The safety device according to claim 1 , wherein the separating wall extends into a widened section of the guide track that extends parallel to the central axis of the safety device.

4. The safety device according to claim 1 , wherein the separating wall has an axial dimension extending parallel to the central axis that defines substantially a minimal axial distance that the needle shield has to be moved with respect to the support body until the safety device is prevented from re-usage.

5. The safety device according to claim 1 , wherein an audible feedback is generated when the needle shield is retracted with respect to the support body by a distance that matches or exceeds a minimal axial distance.

6. The safety device according to claim 1 , wherein the separating wall prevents the guide pin from accessing an end position within the guide track from one of a distal direction and a proximal direction, whereas guide pin is allowed to enter the end position from the other of the distal direction and the proximal direction.

7. The safety device according to claim 1 , wherein the guide track is formed into a surface of the support body or into a surface of the needle shield as a recess.

8. The safety device according to claim 1 , wherein the guide track forms an aperture in one of the needle shield or the support body.

9. The safety device according to claim 8 , wherein the separating wall is flexible and the guide pin moves along the guide track to deflect the separating wall, whereby the deflection of the flexible separating wall depends on the deflection of the flexible arm.

10. The safety device according to claim 8 , wherein an elasticity of the separating wall is adapted to an elasticity of the flexible arm, so that the separating wall is deflectable by the deflected flexible arm.

11. The safety device according to claim 1 , wherein the guide pin is biased in the lateral direction by the deflected flexible arm.

12. The safety device according to claim 1 , wherein the flexible arm in a rest position extends essentially parallel to the central axis, the flexible arm being in the rest position when the guide pin is in the start position and the end position.

13. The safety device according to claim 1 , wherein the guide track comprises an inclined section oriented at an angle with respect to the central axis.

14. The safety device according to claim 13 , wherein the needle shield is retained in an initial position by the guide pin being retained in the start position within the inclined section of the guide track, the needle shield in the initial position protruding the support body in a distal direction, the needle shield is movable from the initial position to a retracted position and further to an advanced position, the needle shield protruding the support body in the initial position and in the advanced position.

15. The safety device according to claim 14 , wherein the safety device comprises a compression spring arranged in a non-energized state when the needle shield is in the initial position.

16. The safety device according to claim 1 , further comprising a first longitudinal groove and a first longitudinal tongue to inhibit relative rotation of the needle shield and the support body.

17. An injection device comprising:
a pre-filled syringe with a hypodermic needle attached to a distal end of the pre-filled syringe; and a safety device comprising:
a hollow support body for mounting the pre-filled syringe therein such that the hypodermic needle protrudes past a distal end of the support body,
a hollow needle shield that is slidable relative to the support body, the needle shield and the support body being configured such that relative rotation of the support body and the needle shield is inhibited, and
a guiding mechanism to guide movement of the needle shield relative to the support body, the guiding mechanism comprising:
a flexible arm,
a guide pin extending from the flexible arm in a radial direction,
a guide track, wherein the guide pin protrudes into the guide track, and
a separating wall that extends into the guide track in a direction parallel to a central axis of the safety device,
wherein the guide pin is configured to move along the guide track to deflect the flexible arm in a lateral direction perpendicular to the central axis when the needle shield is slid relative to the support body,
wherein the guide pin is movable within the guide track from a start position through an intermediate position to an end position such that a distal end of the needle of the pre-filled syringe is surrounded by the needle shield when the guide pin is in the start position and the end position, and
wherein the flexible arm interacts with the separating wall to guide movement of the guide pin along the guide track.

18. The injection device according to claim 17 , wherein the needle shield is movable from an initial position to a retracted position and further to an advanced position, the needle being surrounded by the needle shield in the initial position and in the advanced position and exposed in the retracted position.

19. The injection device according to claim 17 , wherein the flexible arm in a rest position extends essentially parallel to the central axis, the flexible arm being in the rest position when the guide pin is in the start position and the end position.

Assignees

• Roberts Gareth
• Ward Chris
• Ekman Matthew
• Sanofi Aventis Deutschland

Inventors

• Roberts Gareth
• Ward Chris
• Ekman Matthew

Classifications

• A61M5/3202

  Devices for protection of the needle before use, e.g. caps (A61M5/50 takes precedence; for infusion spikes A61M5/1626; protectors for sharps A61B50/3001) · CPC title

• A61M5/3205

  Apparatus for removing or disposing of used needles or syringes, e.g. containers; Means for protection against accidental injuries from used needles (for sharps A61B50/362; disintegrating apparatus in general B02C, e.g. B02C19/0075, B23H9/001; disposal of medical waste in general B09B3/00; receptacles for refuse disposal in general B65F1/00) · CPC title

• A61M5/50

  having means for preventing re-use, or for indicating if defective, used, tampered with or unsterile {(retractable needles or needle protectors with means for preventing re-use A61M5/321)} · CPC title

• A61M2005/3267

  Biased sleeves where the needle is uncovered by insertion of the needle into a patient's body · CPC title

• A61M5/326

  Fully automatic sleeve extension, i.e. in which triggering of the sleeve does not require a deliberate action by the user · CPC title