Transfer needle safety apparatus

• US 20040215106A1
• Filed: 04/24/2003
• Published: 10/28/2004
• Est. Priority Date: 04/24/2003
• Status: Active Grant

• Current Assignee: Kpr U.S., LLC (Cardinal Health, Inc.), Biomerieux Incorporated (Compagnie Merieux Alliance SAS)
• Original Assignee: Tyco Healthcare Group LP (Medtronic Plc)
• Inventors: Ronsick, Christopher S., Sampson, Eric
• Granted Patent: US 7,261,698 B2
• Time in Patent Office: Days
• US Class Current: 600/576
• CPC Class Codes: A61B 5/15003 for venous or arterial blood
• CPC Class Codes: A61B 5/150389 Hollow piercing elements, e.g. canulas, needles, for piercing the skin
• CPC Class Codes: A61B 5/150503 Single-ended needles hollow piercing element tip design A61B5/150396, needle sets for catheters A61M25/06, needles for bringing media into the body A61M5/32
• CPC Class Codes: A61B 5/150992 Blood sampling from a fluid line external to a patient, such as a catheter line, combined with an infusion line; blood sampling from indwelling needle sets, e.g. sealable ports, luer couplings, valves tubing connectors and couplings A61M39/00
• CPC Class Codes: A61B 5/154 Devices using pre-evacuated means
• CPC Class Codes: A61B 5/155 Devices specially adapted for continuous or multiple sampling, e.g. at predetermined intervals devices loaded with multiple lancets simultaneously A61B5/15146
• CPC Class Codes: A61J 1/2055 having gripping means
• CPC Class Codes: A61J 1/2065 having aligning and guiding means
• CPC Class Codes: A61J 1/2096 Combination of a vial and a syringe for transferring or mixing their contents
• CPC Class Codes: Y10S 604/905 Aseptic connectors or couplings, e.g. frangible, piercable

Abstract

A transfer needle safety apparatus including a guide port adapted to fit a variety of body fluid receptacle sizes. A sleeve substantially fills the cavity inside a needle shield. The sleeve includes a robust external lead-in structure for aligning/assembling and centering the sleeve in the shield and a robust internal lead-in structure for aligning and centering a narrow body receptacle onto a needle. The sleeve engages a long section of the outer surface of a receptacle thereby preventing rocking or lateral motion of a receptacle septum relative to a needle tip. Streamlined gripping features allow removal of the sleeve from the shield.

Claims

1. A transfer needle safety apparatus comprising:

a shield having a wide diameter proximal end side-wall defining a cavity and a rim defining a substantially full diameter proximal opening, said shield having a narrower diameter distal end wall with an open tubular extension extending distally therefrom, said shield having an inner contour adapted to receive a wide body collection vessel; and

a removable sleeve adapted to fit into said cavity and self align coaxially therewith, said removable sleeve comprising an inner cylinder defining an open proximal end and an open distal end and having an inside diameter adapted for receiving a narrow body collection vessel.

2. A transfer needle safety apparatus according to claim 1 comprising a plurality of ribs extending radially from an outside surface of said inner cylinder to an inside diameter of said shield and cooperatively engaged therewith to provide coaxial alignment of said inner cylinder with said outside cylinder.

3. A transfer needle safety apparatus according to claim 1 including a transfer needle non-removably installed with said shield, said transfer needle extending proximally into said cavity from said distal end wall, and distally into said tubular extension opening.

4. A transfer needle safety apparatus according to claim 1 wherein said tubular extension is adapted to a luer of a fluid transfer syringe.

5. A transfer needle safety apparatus according to claim 4 wherein said tubular extension includes threads adapted for attachment to a threaded luer of a fluid transfer syringe.

6. A transfer needle safety apparatus according to claim 4 wherein said tubular extension opening includes a distal end inside diameter adapted for receiving a male luer of a fluid transfer syringe.

7. A transfer needle safety apparatus according to claim 4 wherein said tubular extension includes a luer lock fitting for removable attachment to a cooperating luer lock fitting of a fluid transfer syringe.

8. The transfer needle safety apparatus according to claim 1 wherein said open proximal end of said inside cylinder includes an annular flange extending to a diameter equal or greater than said proximal opening in said outer cylinder, and wherein said flange including a rounded shoulder blending into said open proximal end of said inner cylinder

9. The transfer needle safety apparatus according to claim 1 wherein at least one slot is provided in said side-wall adjacent to said proximal opening to allow gripping and removal of said sleeve from said shield.

10. The transfer needle safety apparatus according to claim 1 wherein said removable sleeve includes a cylindrical proximal extension adjacent to said open proximal end to allow gripping and removal of said sleeve from said shield.

11. A transfer needle safety apparatus according to claim 1 wherein said shield proximal end side wall includes an internal undercut adjacent to said rim and wherein at least one of said ribs includes an inwardly formed step which engages said undercut when said sleeve is installed in said shield for removable retention of said sleeve in said cavity.

12. A transfer needle safety apparatus according to claim 1 comprising features incorporated with said sleeve and said shield to provide audible feedback indicating full insertion of said sleeve to said shield.

13. A transfer needle safety apparatus according to claim 2 wherein each of said ribs include an inclined distal end surface for aligning said sleeve with said shield when said inclined distal end surface engages said rim during installation of said sleeve to said shield.

14. A transfer needle safety apparatus according to claim 2 including a transfer needle non-removably installed with said shield, said transfer needle extending proximally into said cavity from said distal end wall, and distally into said tubular extension opening;

wherein each of said ribs extend far enough distally to engage said side-wall and ensure alignment of said sleeve within said shield before said distal end of said inner cylinder reaches said transfer needle tip during installation of said sleeve to said shield.

15. A transfer needle safety apparatus according to claim 14 wherein at least one of said ribs include a rib extension protruding distally therefrom and wherein said shield includes at least one clearance window configured to accept said rib extension.

16. A transfer needle safety apparatus comprising:

a shield having a side-wall defining a cavity with a substantially full diameter proximal opening and having a narrower diameter distal end wall with an open tubular extension extending distally therefrom, said shield having an inside diameter adapted to receive a wide body collection vessel; and

a removable sleeve adapted to fit into said cavity and self align coaxially therewith, said removable sleeve comprising an inner cylinder defining an open proximal end and an open distal end and having an inside diameter adapted for receiving a narrow body collection vessel;

said open proximal end of said inside cylinder having a finger extending to a diameter equal or greater than said proximal opening in said shield

17. A transfer needle safety apparatus according to claim 16 wherein said side-wall includes a slot disposed therein configured for receiving said finger of said removable sleeve.

18. A method of safely transferring body fluids to a vessel comprising:

providing a shield having a side-wall defining a cavity with a rim defining a substantially full diameter proximal opening and having a narrower diameter distal end wall with an open tubular extension extending distally therefrom, said shield having an inside diameter adapted to receive a wide body collection vessel; and

providing a fluid transfer needle permanently installed with said shield and extending from the proximal end of said tubular extension into said cavity;

providing a removable sleeve adapted to fit into said cavity and self align coaxially therewith, said removable sleeve comprising an inner cylinder defining an open proximal end and an open distal end and having an inside diameter adapted for receiving a narrow body collection vessel;

fitting the luer of fluid transfer syringe to the distal end of said tubular extension;

inserting the mouth of a narrow body fluid receptacle having a puncturable septum into said sleeve and puncturing said septum with said needle;

transferring fluid from said syringe into said narrow body receptacle; and

removing said narrow body receptacle from said sleeve.

19. The method according to claim 18 wherein said tubular extension includes a threaded wall and wherein said luer is fitted to said tubular extension by cooperating threads disposed on said luer engaging said threaded wall.

20. The method according to claim 18 further comprising:

removing said sleeve from said shield;

inserting the mouth of a wide body fluid receptacle having a puncturable septum into said shield and puncturing said septum with said needle;

transferring fluid from said syringe into said wide body receptacle; and

removing said wide body receptacle from said shield.

21. A transfer needle safety apparatus comprising:

a tubular shield having an open proximal end and a distal portion that includes a lumen configured to facilitate fluid transfer,

wherein the distal portion of the shield defines a plurality of internally stepped shoulders.

22. A transfer needle safety apparatus according to claim 21, wherein the plurality of internally stepped shoulders are configured to support alternately sized receptacles, the receptacles being adapted for communication with the lumen.

23. A transfer needle safety apparatus according to claim 21, wherein the plurality of internally stepped shoulders are configured to guide receptacles into engagement with the shield.

24. A transfer needle safety apparatus according to claim 21, wherein the shield includes at least one opening defined in a sidewall thereof.

25. A transfer needle safety apparatus according to claim 21, wherein a needle cannula defines at least a portion of the lumen.

26. A transfer needle safety apparatus according to claim 21, further comprising a sleeve having a proximal end, a distal end and being configured for disposal of a receptacle therein, the distal end being supported by at least one of the shoulders.

27. A transfer needle safety apparatus according to claim 26, wherein the sleeve includes a plurality of nibs extending radially outward therefrom, the ribs engaging the shield to provide coaxial alignment therewith.

28. A transfer needle safety apparatus according to claim 27, wherein the ribs define an inclined distal end surface that is configured to engage an inner surface of the shield.