NEEDLE SAFETY DEVICE AND ASSEMBLY

• US 20120035552A1
• Filed: 08/01/2011
• Published: 02/09/2012
• Est. Priority Date: 08/05/2010
• Status: Active Grant

• Current Assignee: B Braun Melsungen AG (B. Braun Holding GmbH & Co. KG)
• Original Assignee: B Braun Melsungen AG (B. Braun Holding GmbH & Co. KG)
• Inventors: Woehr, Kevin
• Granted Patent: US 9,782,546 B2
• Time in Patent Office: Days
• US Class Current: 604/246
• CPC Class Codes: A61M 25/0606 "Over-the-needle" catheter assemblies, e.g. I.V. catheters
• CPC Class Codes: A61M 25/0618 having means for protecting only the distal tip of the needle, e.g. a needle guard
• CPC Class Codes: A61M 5/3273 freely sliding on needle shaft without connection to syringe or needle
• CPC Class Codes: A61M 5/329 characterised by features of the needle shaft
• CPC Class Codes: Y10T 29/49826 Assembling or joining

Abstract

Safety intravenous catheters (IVCs) are disclosed herein having a catheter hub with a catheter tube, a needle with a needle hub, and a needle guard. The needle guard is configured to be positioned at least partially within an interior space of the catheter hub and is retained thereto by mechanical engagement between the two. Following removal of the needle from the catheter hub, the needle guard is configured to disengage from the catheter hub and attach over a tip of the needle to shield the needle tip from inadvertent needlesticks. The needle guard having an angled end section configured with a length and a width to retain the needle tip within a tip holding space behind the angled end section.

Claims

1. A needle assembly comprising:

a non-metallic base portion comprising a wall having bore, a proximally facing surface, and a distally facing surface; and

a first arm including a first free end and a second arm including a second free end extending generally axially from the base portion in a distal direction, the first free end extending beyond the second free end and including an angled end section that extends toward the second arm,

wherein the angled distal end section comprises a length and a width configured to retain a needle having a needle diameter within a tip holding space; and

wherein the length and width of the angled distal end section are larger than the needle diameter and the width is at least two times larger than the needle diameter.

2. The needle assembly of claim 1, further comprising a metal insert disposed within a bore of the needle guard to allow contact between the metal insert and a change in profile positioned adjacent to a needle tip when the needle is in a protected position.

3. The needle assembly of claim 1, further comprising a shield member made from a material different from the non-metallic material of the base portion positioned in or on the angled end section.

4. The needle assembly of claim 1, further comprising a catheter hub comprising a guard engaging section adapted to engage a hub engaging section on the needle guard.

5. The needle assembly of claim 4, further comprising a tensioning member located about the needle guard to bias the first arm and the second arm toward one another.

6. The needle assembly of claim 4, further comprising a port located on the catheter hub, which is spaced from an open proximal end of the catheter hub.

7. The needle assembly of claim 6, further comprising a sleeve for controlling fluid flow through port.

8. The needle assembly of claim 1, wherein the needle guard comprises a flap on the first arm, the second arm, or both the first arm and the second arm.

9. A needle assembly comprising:

a non-metallic base portion comprising wall having a bore, a bore length, a bore diameter, a proximally facing surface, and a distally facing surface; and

a first arm including a first free end and a second arm including a second free end extending generally axially in a distal direction from the base portion, the first free end extending beyond the second free end and including an angled end section comprising a first side edge, a second side edge, a length, and a width that extends toward the second arm;

a needle tip holding space defined at least in part by the base portion, the first arm, the second arm, and the angled end section;

a needle having a tip and a diameter,

wherein the first arm and the second arm are biased so as to move between a ready position in which the angled end section abuts the needle and a protected position in which the needle tip is confined within a tip holding space; and

wherein the length and width of the angled distal end section are larger than the needle diameter and cooperate with the bore length and bore diameter to confine the needle tip within the needle tip holding space.

10. The needle assembly of claim 9, wherein the needle tip is prevented from pivoting beyond the first side edge or the second side edge by the cooperation between the length and width of the angled distal end section, the bore length and the bore diameter.

11. The needle assembly of claim 9, further comprising a cylindrical insert made from a different material than the non-metallic material of the base portion.

12. The needle assembly of claim 11, wherein the needle comprises a change in profile and wherein the change in profile abuts the insert.

13. The needle assembly of claim 9, further comprising a tensioning member for biasing the first arm and the second toward one another.

14. The needle assembly of claim 9, further comprising a shield member made from a different material than the non-metallic material of the base portion located at the angled distal end section.

15. A method for assembling a needle assembly comprising:

providing a needle having a needle shaft, a needle tip, and a change in profile near the needle tip on a needle hub;

placing a needle guard slidably about the needle shaft;

said needle guard comprising;

a non-metallic base portion comprising wall having a bore, a bore length, a bore diameter, a proximally facing surface, and a distally facing surface; and

a first arm including a first free end and a second arm including a second free end extending generally axially in a distal direction from the base portion, the first free end extending beyond the second free end and including an angled end section comprising a first side edge, a second side edge, a length, and a width that extends toward the second arm;

a needle tip holding space defined at least in part by the base portion, the first arm, the second arm, and the angled end section;

wherein the length and width of the angled distal end section are larger than a needle diameter and cooperate with the bore length and bore diameter to confine the needle tip within the needle tip holding space;

moving the needle guard to a proximal position on the needle shaft so that the angled end section is based by the needle shaft and is spaced from the needle tip.

16. The method of claim 15, further comprising placing the needle guard inside a catheter hub so that a guard engaging section on the catheter hub engages the hub engaging section on the needle guard.

17. The method of claim 16, wherein the engagement occurs only after moving the needle guard relative to the catheter hub.

18. The method of claim 15, further comprising an insert located in the bore of the needle guard.

19. The method of claim 18, further comprising moving the change in profile against the insert.

20. The method of claim 19, wherein a separation force to pull the change in profile away from the needle guard is at least 3 times that of a similar needle guard without the insert.