Pen needle and safety shield system

• US 20030014018A1
• Filed: 07/09/2002
• Published: 01/16/2003
• Est. Priority Date: 08/02/2000
• Status: Active Grant

• Current Assignee: Becton, Dickinson & Co
• Original Assignee: Becton, Dickinson & Co
• Inventors: De Salvo, David, Giambattista, Lucio
• Granted Patent: US 6,986,760 B2
• Time in Patent Office: Days
• US Class Current: 604/198
• CPC Class Codes: A61M 2005/3104 Caps for syringes without needle
• CPC Class Codes: A61M 2005/3215 Tools enabling the cap placement
• CPC Class Codes: A61M 2005/3247 Means to impede repositioning of protection sleeve from needle covering to needle uncovering position
• CPC Class Codes: A61M 2005/3267 Biased sleeves where the needle is uncovered by insertion of the needle into a patient's body
• CPC Class Codes: A61M 5/002 Packages specially adapted therefor, e.g. for syringes or needles, kits for diabetics needle protection, e.g. caps, A61M5/3202; for sharps A61B50/3001
• CPC Class Codes: A61M 5/24 Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or carpules, e.g. automatic ampoules or carpules A61J1/06
• CPC Class Codes: A61M 5/3202 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 Class Codes: A61M 5/3205 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 Class Codes: A61M 5/326 Fully automatic sleeve extension, i.e. in which triggering of the sleeve does not require a deliberate action by the user
• CPC Class Codes: A61M 5/3271 with guiding tracks for controlled sliding of needle protective sleeve from needle exposing to needle covering position
• CPC Class Codes: A61M 5/347 rotatable, e.g. bayonet or screw A61M5/344 takes precedence
• CPC Class Codes: A61M 5/5086 for indicating if defective, used, tampered with or unsterile

Abstract

A safety shield system for a needle cannula of a pen needle injector or similar device, wherein a safety shield may be retracted from a first position enclosing the needle cannula to a second position exposing the needle cannula for injection. The safety shield system permits retraction of the safety shield during use, but extends the shield enclosing the needle cannula in a locked position following use. The shield system is utilized with a pen needle injector having a double-ended needle cannula mounted in a hub member received on an open end of the pen needle injector. The assembly is disposed of by removing the system and storing the assembly in the cup-shaped top cap enclosing the exposed end of the needle cannula within the cap. The top cap includes internal radial ribs preventing retraction of the shield prior to removing the top cap preventing inadvertently piercing the top cap during assembly. In addition, a bottom cap may be interlocked to the top cap to completely encompass the needle cannula, thereby ensuring safe disposal of the assembly.

Claims

1. A safety shield system for use with a body having fluid disposed therein, the safety shield system including:

a hub member adapted to receive the body;

a needle cannula, having a lumen extending therethrough, mounted to the hub member for transferring the fluid from the body;

a clip member attached to the hub member and having at least one laterally projecting finger;

a shield moveably mounted with respect to the hub between a first position surrounding the needle cannula and a second position exposing the needle cannula, the shield including at least one opening for receiving the finger when the shield is first retracted to the second position to expose the needle cannula and then extended to the first position surrounding the needle cannula such that the finger locks the shield in the first position to prevent further exposure of the needle cannula; and

a spring disposed within the shield for continuously biasing the shield toward the first position.

2. The safety shield system defined in claim 1 wherein the finger is made of a resilient material and includes a hook-shaped end portion opening toward the shield and the opening extends through a side wall of the shield for receiving the hook-shaped end portion therethrough to lock the shield in the first position surrounding the needle cannula.

3. The safety shield system defined in claim 1 wherein the clip member includes a plurality of spaced resilient fingers and the shield includes a plurality of corresponding openings through side walls of the shield for receiving the fingers and locking the shield in the first position surrounding the needle cannula.

4. The safety shield system defined in claim 3 wherein the clip member includes a common base with each of the resilient fingers extending from the base.

5. The safety shield system defined in claim 4 wherein the spring is a spiral spring having one end abutting the common base and an opposed end biased against the shield.

6. The safety shield system defined in claim 1 wherein the needle cannula extends through the hub member to define a first end for extending into the body to puncture a closure in a container received in the body, and a second end extending into the shield.

7. The safety shield system defined in claim 6 wherein the shield is generally cup-shaped having an open end received around the clip member and a generally closed end having a central opening therethrough receiving the second end of the needle cannula, and the spring being a spiral spring biased against the generally closed end of the shield.

8. The safety shield system defined in claim 1 wherein the finger includes a hook-shaped end portion which is larger than the opening in the shield such that the resilient finger initially slides over the opening when the shield is retracted to the second position.

9. The safety shield system defined in claim 8 wherein the opening includes a chamfer with the finger first engaging the chamfer and then extending into the opening when the shield returns to the first position from the second position.

10. The safety shield system defined in claim 8 wherein the shield includes at least one radial groove and the hub member includes at least one radially extending rib disposed within the groove to prevent rotation of the shield relative to the clip member.

11. The safety shield system defined in claim 8 wherein the shield includes a plurality of spaced radial grooves and the hub member includes a plurality of spaced radially extending ribs with a corresponding rib disposed within each groove to prevent rotation of the shield relative to the clip member.

12. The safety shield system defined in claim 11 further including a removable cup-shaped top cap initially received over the shield.

13. The safety shield system as defined in claim 12 wherein the cup-shaped top cap includes inwardly projecting ribs which are disposed within the grooves of the shield for preventing retraction of the shield relative to the hub member when the top cap is received over the shield.

14. The safety shield system defined in claim 13 wherein the top cap includes at least one first internal tab which engages the ribs of the hub member to secure the top cap to the hub member and provide a degree of resistance during removal of the top cap from the hub member.

15. The safety shield system defined in claim 13 further including a removable cup-shaped bottom cap initially received over the hub member opposite the top cap.

16. The safety shield system defined in claim 15 wherein the bottom cap interengages the top cap when the top cap is received over the shield and the bottom cap is received over the hub member thereby forming a sterile barrier.

17. The safety shield system defined in claim 16 wherein the top cap includes at least one second internal tab which engages the bottom cap to secure the bottom cap to the top cap and provide a degree of resistance during removal of the bottom cap from the top cap.

18. The safety shield system defined in claim 16 wherein the top cap includes a first camming surface and the bottom cap includes a second camming surface with the first and second camming surfaces abutting each other during rotation of the bottom cap relative to the top cap such that the bottom cap simultaneously moves axially away from the top cap.

19. The safety shield system defined in claim 1 further including a removable cup-shaped top cap initially received over the shield and a removable cup-shaped bottom cap initially received over the hub member opposite the top cap to completely surround the needle cannula.

20. A pen needle and safety shield system for use with a container having fluid disposed therein, the pen needle and safety shield system comprising:

a pen injector having a body portion for receiving the container;

a hub member removably mounted to the body portion;

a needle cannula mounted to and extending through the hub member having a first end extending into the body portion for fluid communication with the container, and a second end extending away from the body portion for injection and transfer of the fluid from the container to a user;

a clip member mounted to the hub member and having a plurality of spaced laterally projecting resilient fingers;

a shield moveably mounted to the clip member between a first position surrounding the second end of the needle cannula and a second position exposing the second end of the needle cannula, the shield including a plurality of openings for receiving the fingers when the shield is first retracted to the second position to expose the needle cannula and then extended to the first position surrounding the needle cannula such that the fingers lock the shield in the first position to prevent further exposure of the needle cannula; and

a spring disposed within the shield for continuously biasing the shield toward the first position.

21. The pen needle and safety shield system defined in claim 20 wherein the resilient fingers each include a hook-shaped end portion opening toward the shield and the openings extend through a side wall of the shield for receiving the hook-shaped end portions therethrough to lock the shield in the first position surrounding the needle cannula.

22. The pen needle and safety shield system defined in claim 20 wherein the shield is generally cup-shaped having an open end received around the clip member and a generally closed end having a central opening therethrough receiving the second end of the needle cannula, and the spring being a spiral spring biased against the generally closed end of the shield.

23. The pen needle and safety shield system defined in claim 20 wherein the resilient fingers each includes a hook-shaped end portion which is larger than the openings in the shield such that the resilient fingers initially slide over the openings when the shield is retracted to the second position.

24. The pen needle and safety shield system defined in claim 23 wherein the openings each includes a chamfer with the fingers first engaging the chamfers and then extending into the openings when the shield returns to the first position from the second position.

25. The pen needle and safety shield system defined in claim 23 wherein the shield includes a plurality of spaced radial grooves and the hub member includes a plurality of spaced radially extending ribs with a corresponding rib disposed within each groove to prevent rotation of the shield relative to the clip member.

26. The pen needle and safety shield system defined in claim 25 further including a removable cup-shaped top cap initially received over the shield.

27. The pen needle and safety shield system as defined in claim 26 wherein the cup-shaped top cap includes inwardly projecting ribs which are disposed within the grooves of the shield for preventing retraction of the shield relative to the hub member when the top cap is received over the shield.

28. The pen needle and safety shield system defined in claim 27 wherein the top cap includes a plurality of first internal tabs which engage the ribs of the hub member to secure the top cap to the hub member and provide a degree of resistance during removal of the top cap from the hub member.

29. The pen needle and safety shield system defined in claim 27 further including a removable cup-shaped bottom cap initially received over the hub member opposite the top cap.

30. The pen needle and safety shield system defined in claim 29 wherein the bottom cap interengages the top cap when the top cap is received over the shield and the bottom cap is received over the hub member.

31. The pen needle and safety shield system defined in claim 30 wherein the top cap includes a plurality of second internal tabs which engage the bottom cap to secure the bottom cap to the top cap and provide a degree of resistance during removal of the bottom cap from the top cap.

32. The safety shield system defined in claim 31 wherein the top cap includes a first camming surface and the bottom cap includes a second camming surface with the first and second camming surfaces abutting each other during rotation of the bottom cap relative to the top cap such that the bottom cap simultaneously moves axially away from the top cap.

33. A safety shield system for use with a container having a fluid therein, the system including:

a hub adapted to releasably engage the container, the hub having an axis;

a needle cannula having a lumen extending therethrough, mounted to the hub, the cannula having a first end and a second end;

wherein, when the hub is engaged to the container, the first end of the needle cannula is in fluid communication with the container;

a clip secured on the hub;

a shield slidably mounted to the hub for axial movement between a first position and a second position;

wherein, in the first position, the second end of the needle cannula is contained within the shield; and

wherein, in the second position, the needle extends out of the shield;

wherein the clip engages the shield when the shield is moved from the second position to the first position to prevent axial movement of the shield to the second position.

34. The system of claim 33 further including a guide disposed in the shield and forming a channel, wherein, when the shield is in the first position and in the second position, the needle cannula is, at least in part, within the channel.

35. The system of claim 33 in which the clip is integrally formed with the hub.

36. The system of claim 33 wherein the clip further comprises at least one laterally projecting finger and an opening is disposed in the shield, wherein the finger engages the opening as the shield is moved to the first position from the second position.

37. The system of claim 36 in which the finger comprises a hook-shaped end portion that flexes into the opening to prevent axial movement of the shield.

38. The system of claim 37 in which the hook-shaped end portion includes a tip that is longer in the axial direction than the opening.

39. The system of claim 33 further comprising a rib attached to the hub aligned with a rib on the shield to prevent axial movement of the shield with respect to the hub, at least in a first direction.