Pen needle and safety shield system

• US 6,986,760 B2
• Filed: 07/09/2002
• Issued: 01/17/2006
• Est. Priority Date: 08/02/2000
• Status: Expired due to Term

• Current Assignee: Becton, Dickinson & Co
• Original Assignee: Becton, Dickinson & Co
• Inventors: De Salvo, David, Giambattista, Lucio
• Primary Examiner(s): Lucchesi, Nicholas D.
• Assistant Examiner(s): Maiorino, Roz
• Application Number:
  US10/191,714
• Publication Number:
  US 20030014018A1
• Time in Patent Office: 1,288 Days
• Field of Search: 604110-198, 604/201, 604/221, 604/241, 604/218, 604/263
• 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 mounted to the hub member and having a first end and a second end;

a clip member attached to the hub member and having a lateral projection;

a shield 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, the shield being moveably mounted with respect to the hub member 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 lateral projection 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 lateral projection locks the shield in the first position to prevent subsequent movement of the shield from the first position to the second position;

a spring disposed within the shield for biasing the shield toward the first position; and

a cap having a closed end and having means for non-removably securing the cap over the open end of the shield following use of the safety shield system to prevent re-use thereof.

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

8. The safety shield system defined in claim 7 wherein the opening includes a chamfer with the lateral projection first engaging the chamfer and then extending into the opening when the shield returns to the first position from the second position.

9. The safety shield system defined in claim 7 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.

10. The safety shield system defined in claim 7 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.

11. The safety shield system as defined in claim 1 wherein the 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 cap is received over the shield.

12. The safety shield system defined in claim 11 wherein the cap includes at least one first internal tab which engages the ribs of the hub member to secure the cap to the hub member and provide a degree of resistance during removal of the cap from the hub member.

13. The safety shield system defined in claim 11 further including a removable cup-shaped bottom cap initially received over the hub member opposite the top cap.

14. The safety shield system defined in claim 13 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.

15. The safety shield system defined in claim 14 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.

16. The safety shield system defined in claim 14 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.

17. 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.

18. 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 resilient lateral projections;

a shield 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, the shield being moveably mounted with respect to the hub 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 lateral projections 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 lateral projections lock the shield in the first position to prevent subsequent movement of the shield from the first position to the second position;

a spring disposed within the shield for biasing the shield toward the first position; and

a cap having a closed end and having means for non-removably securing the cap over the open end of the shield following use of the pen needle and safety shield system to prevent re-use thereof.

19. The pen needle and safety shield system defined in claim 18 wherein the resilient lateral projections 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.

20. The pen needle and safety shield system defined in claim 18 wherein the resilient lateral projections each includes a hook-shaped end portion which is larger than the openings in the shield such that the resilient lateral projections initially slide over the openings when the shield is retracted to the second position.

21. The pen needle and safety shield system defined in claim 20 wherein the openings each includes a chamfer with the projections first engaging the chamfers and then extending into the openings when the shield returns to the first position from the second position.

22. The pen needle and safety shield system defined in claim 20 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.

23. The pen needle and safety shield system as defined in claim 18 wherein the 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 cap is received over the shield.

24. The pen needle and safety shield system defined in claim 23 wherein the cap includes a plurality of first internal tabs which engage the ribs of the hub member to secure the cap to the hub member and provide a degree of resistance during removal of the cap from the hub member.

25. The pen needle and safety shield system defined in claim 23 further including a removable cup-shaped bottom cap initially received over the hub member opposite the top cap.

26. The pen needle and safety shield system defined in claim 25 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.

27. The pen needle and safety shield system defined in claim 26 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.

28. The safety shield system defined in claim 27 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.