Safety IV catheter assembly with seal

• US 8,979,802 B2
• Filed: 08/26/2013
• Issued: 03/17/2015
• Est. Priority Date: 03/15/2013
• 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
• Primary Examiner(s): Lucchesi, Nicholas
• Assistant Examiner(s): BUI, ANH T
• Application Number:
  US13/975,986
• Publication Number:
  US 20140276433A1
• Time in Patent Office: 568 Days
• Field of Search: 604/164.08, 604/263, 604/164.12
• US Class Current: 604/164.08
• CPC Class Codes: A61M 25/0014 Connecting a tube to a hub
• CPC Class Codes: A61M 25/0097 characterised by the hub connectors A61M39/10
• 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 39/0606 without means for adjusting the seal opening or pressure A61M39/0693 takes precedence
• CPC Class Codes: A61M 5/3273 freely sliding on needle shaft without connection to syringe or needle
• CPC Class Codes: Y10T 29/49826 Assembling or joining

Abstract

Catheter assemblies are described having a catheter hub with a catheter tube and a needle hub with a needle projecting through the catheter tube. The catheter hub has at least two seals with at least one being a temporary seal that ends or terminates upon movement of a needle and/or a guard. Different needle guards are provided that can be seated differently within the catheter hub to seal against the elastic seal.

Claims

1. A catheter assembly comprising:

a catheter hub with a catheter tube having a tube end, said catheter hub comprising a body comprising an interior surface defining an interior cavity comprising a first inside diameter section distal of a second inside diameter section and wherein said first inside diameter section is larger in dimension than said second inside diameter section;

a needle hub with a needle having a needle tip, a nominal needle diameter, and a needle shaft projecting through the catheter hub and the catheter tube such that the needle tip extends distally of the tube end in a ready position;

an elastic seal held against a shoulder in the interior cavity of the catheter hub, said elastic seal comprising an outside diameter and an inside diameter and wherein said inside diameter being sufficiently larger than the nominal needle diameter so that the needle shaft does not come in contact with the inside diameter of the elastic seal in the ready position;

a needle guard for covering the needle tip in a protective position located in the interior cavity of the catheter hub and in contact with the elastic seal;

a temporary seal for limiting fluid flow formed at a point where the needle guard contacts the elastic seal.

2. The catheter assembly of claim 1, wherein the needle guard comprises a cap comprising a dome surface and wherein the dome surface is axially loaded against the elastic seal.

3. The catheter assembly of claim 1, wherein the temporary seal terminates when the needle guard moves in a proximal direction at which point fluid can freely flow through the inside diameter of the elastic seal.

4. The catheter assembly of claim 1, wherein the elastic seal is compressed inside a groove comprising the shoulder.

5. The catheter assembly of claim 1, wherein the needle guard comprises a sleeve comprising an inside diameter, an outside diameter, and a length and wherein a change in profile formed near the needle tip has a larger cross-sectional dimension than the inside diameter of the sleeve.

6. The catheter assembly of claim 1, wherein the needle guard comprises a surface that contacts the needle shaft and wherein the surface that contacts has a coating applied thereon to reduce friction when the needle shaft moves against the surface.

7. The catheter assembly of claim 1, further comprising an installation tool comprising a lengthwise channel for pushing the guard into the interior cavity of the catheter hub.

8. The catheter assembly of claim 1, wherein the needle guard comprises an arm comprising an elbow that contacts the interior surface of the catheter hub.

9. A catheter assembly comprising:

a catheter hub with a catheter tube having a tube end, said catheter hub comprising a body defining an interior cavity having an interior surface with an interior shoulder;

a needle hub with a needle having a needle tip, a nominal needle diameter, and a needle shaft projecting through the catheter hub and the catheter tube such that the needle tip extends distally of the tube end in a ready position;

an elastic seal held against the interior shoulder in the interior cavity of the catheter hub, said elastic seal comprising an outside diameter, an inside diameter, and a side surface located between the inside and outside diameters and wherein said inside diameter being sufficiently larger than the nominal needle diameter so that the needle shaft does not come in contact with the inside diameter of the elastic seal in the ready position;

a needle guard for covering the needle tip in a protective position located in the interior cavity of the catheter hub, said needle guard comprising a distal wall having a distal opening and a distally facing surface in contact with the side surface of the elastic seal;

a temporary seal for limiting fluid flow formed at a point where the needle guard contacts the side surface of the elastic seal.

10. The catheter assembly of claim 9, wherein the interior cavity of the catheter hub comprises a first inside diameter section distal of a second inside diameter section and wherein the first inside diameter section is larger in dimension than the second inside diameter section.

11. The catheter assembly of claim 10, wherein the second inside diameter section is an annular protrusion.

12. The catheter assembly of claim 9, further comprising a hydrophobic filter mounted at the distal opening of the distal wall of the needle guard to at least partially cover the distal opening.

13. The catheter assembly of claim 9, wherein the needle guard comprises a cap, an arm, a proximal wall, a distal wall, and a curved elbow, and wherein the curve elbow contacts the catheter hub.

14. The catheter assembly of claim 9, further comprising micro-channels formed on the elastic seal.

15. The catheter assembly of claim 9, wherein the needle further comprises a change in profile located proximally of the needle tip.

16. A method for manufacturing a catheter assembly comprising:

forming a catheter hub with a catheter tube having a tube end, said catheter hub comprising a body defining an interior cavity having an interior surface with an interior shoulder;

forming a needle hub with a needle having a needle tip, a nominal needle diameter, and a needle shaft projecting through the catheter hub and the catheter tube such that the needle tip extends distally of the tube end in a ready position;

placing an elastic seal in the interior cavity of the catheter hub and against the interior shoulder, said elastic seal comprising an outside diameter, an inside diameter, and a side surface located between the inside and outside diameters and wherein said inside diameter being sufficiently larger than the nominal needle diameter so that the needle shaft does not come in contact with the inside diameter of the elastic seal in the ready position;

placing a needle guard for covering the needle tip in a protective position in the interior cavity of the catheter hub and in contact with the elastic seal; and

forming a temporary seal for limiting fluid flow through the elastic seal at a point where the needle guard contacts the elastic seal.

17. The method of claim 16, further comprising pushing the guard into the interior cavity of the catheter hub with an installation tool comprising a lengthwise channel.

18. The method of claim 16, further comprising a hydrophobic filter mounted at a distal opening of the needle guard.

19. The method of claim 16, further comprising pushing the guard so that an outside surface of the guard is sealed against the inside diameter of the elastic seal.

20. The method of claim 16, further comprising adding a coating onto a surface of the needle guard that contacts the needle shaft.

21. The method of claim 16, wherein the needle guard exerts a force on a distally sloping surface of the interior surface of the catheter hub to force the needle guard against the elastic seal.