Catheter assembly and components thereof

• US 8,591,468 B2
• Filed: 11/05/2012
• Issued: 11/26/2013
• Est. Priority Date: 11/03/2006
• 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, Zerbes, Michael
• Primary Examiner(s): FLICK, JASON E
• Application Number:
  US13/668,667
• Publication Number:
  US 20130060198A1
• Time in Patent Office: 386 Days
• Field of Search: 604/96.01
• US Class Current: 604/164.08
• CPC Class Codes: A61B 5/1411 by percutaneous method, e.g. by lancet
• CPC Class Codes: A61B 5/15003 for venous or arterial blood
• CPC Class Codes: A61B 5/150213 Venting means
• CPC Class Codes: A61B 5/150221 Valves
• CPC Class Codes: A61B 5/150389 Hollow piercing elements, e.g. canulas, needles, for piercing the skin
• CPC Class Codes: A61B 5/150511 Details of construction of shaft
• CPC Class Codes: A61B 5/150648 fully automatically triggered, i.e. the triggering of the protective sleeve does not require a deliberate action by the user such as terminating the contact with the patient's skin
• 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 5/153 Devices specially adapted for taking samples of venous or arterial blood, e.g. with syringes
• CPC Class Codes: A61M 2005/3247 Means to impede repositioning of protection sleeve from needle covering to needle uncovering position
• CPC Class Codes: A61M 2039/0202 for taking samples
• CPC Class Codes: A61M 2039/0205 for injecting media
• CPC Class Codes: A61M 2039/062 used with a catheter
• CPC Class Codes: A61M 2039/0633 the seal being a passive seal made of a resilient material with or without an opening
• CPC Class Codes: A61M 2039/064 Slit-valve
• CPC Class Codes: A61M 2039/0686 comprising more than one seal
• CPC Class Codes: A61M 2209/10 Equipment for cleaning
• 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 25/0625 with a permanent connection to the needle hub, e.g. a guiding rail, a locking mechanism or a guard advancement mechanism
• CPC Class Codes: A61M 25/0631 : having means for fully covering the needle after its withdrawal, e.g. needle being withdrawn inside the handle or a cover being advanced over the needle
• CPC Class Codes: A61M 39/045 : pre-slit to be pierced by blunt instrument
• CPC Class Codes: A61M 39/06 : Haemostasis valves, i.e. gaskets sealing around a needle, catheter or the like, closing on removal thereof
• CPC Class Codes: A61M 39/0693 : including means for seal penetration
• CPC Class Codes: A61M 39/12 : for joining a flexible tube to a rigid attachment
• CPC Class Codes: A61M 39/22 : Valves or arrangement of valves A61M39/02, A61M39/0247, A61M39/16 take precedence; regulating valves in infusion systems A61M5/16881; in devices worn by the patient for the reception of urine, faeces, catamenial or other discharge, or in colostomy devices A61F5/4405
• CPC Class Codes: A61M 5/158 : Needles for infusions; Accessories therefor, e.g. for inserting infusion needles, or for holding them on the body
• CPC Class Codes: A61M 5/3273 : freely sliding on needle shaft without connection to syringe or needle

Abstract

Catheter assemblies are generally discussed herein with particular discussions extended to catheter assemblies having a tip protector, a valve, a valve opener, and optionally a needle wiper. The valve opener is disposed inside a catheter hub and is configured to be pushed by an IV set luer connector to open a valve following successful catheterization to pass fluids or other solutions through the catheter. A tip protector is incorporated to block the needle tip and prevent the same from accidental needle stick. A wiper is optionally included to wipe blood deposits from the needle when the same is retracted from the catheter.

Claims

1. A catheter assembly comprising:

a catheter hub comprising a housing comprising an exterior surface and an interior surface defining a cavity;

a catheter tube attached to the catheter hub and extending distally of the catheter hub;

a needle hub comprising a housing;

a needle having a needle tip attached to the needle hub and projecting distally of the needle hub and into the catheter tube;

a valve for limiting blood backflow positioned in the interior cavity of the catheter hub;

a valve opener for opening the valve positioned proximally of the valve; and

a self-activating device for covering the needle, comprising;

a third housing;

a tip protector accommodated within the third housing for blocking the needle tip; and

an arm extending from the third housing and into the catheter hub to engage the catheter hub and retain the third housing to the catheter hub in a ready to use position.

2. The catheter assembly according to claim 1, wherein the valve comprises a skirt section and a top having a cut-out.

3. The catheter assembly according to claim 2, wherein the needle projects through the cut-out.

4. The catheter assembly according to claim 2, wherein the cut-out comprises one or more slits for expanding the cut-out when deflected by the valve opener.

5. The catheter assembly according to claim 2, wherein a plurality of bumps, stretched ridges or protuberances are incorporated around an external circumference of the skirt section for ensuring sufficient air flow between the valve skirt and an inside surface of the catheter hub for purposes of blood flashback.

6. The catheter assembly according to claim 1, wherein the valve opener comprises an actuating end for opening the valve.

7. The catheter assembly according to claim 6, wherein the actuating end comprises a frusto-conical shape distal end.

8. The catheter assembly according to claim 6, wherein the actuating end comprises an undulating surface or a barb for gripping engagement with the valve.

9. The catheter assembly according to claim 6, wherein the actuating end comprises a generally planar proximally facing surface and a passage or lumen for receiving the needle.

10. The catheter assembly according to claim 1, wherein the third housing is disposed at the proximal end of the catheter hub in the ready to use position.

11. The catheter assembly according to claim 1, wherein the needle comprises a crimp, bump or clip engagement section.

12. The catheter assembly according to claim 11, wherein the crimp, bump or clip engagement section engages an opening to secure the device for covering the needle to the needle.

13. The catheter assembly according to claim 1, wherein the arm and a second arm extend from the third housing to engage with the catheter hub.

14. The catheter assembly according to claim 13, wherein each arm engages with a bump on the catheter hub.

15. The catheter assembly according to claim 14, wherein each arm is flexible to provide a gripping force against the bump.

16. The catheter assembly according to claim 15, wherein the gripping force is higher than the frictional force to withdraw the needle through the tip protector.

17. The catheter assembly according to claim 1, wherein the tip protector comprises a spring clip.

18. The catheter assembly according claim 1, wherein the self-activating device for covering the needle comprises an arm extending from a proximal wall of the third housing.

19. The catheter assembly according to claim 18, wherein the arm is biased against a side of the needle.

20. The catheter assembly according to claim 1, further comprising a wiper having an opening for wiping the needle.

21. The catheter assembly according to claim 1, wherein the device for covering the needle comprises side walls for surrounding the needle tip.

22. A catheter assembly comprising:

a catheter hub comprising a housing comprising an exterior surface and an interior surface defining a cavity;

a catheter tube attached to the catheter hub and extending distally of the catheter hub;

a needle hub comprising a housing;

a needle having a needle tip attached to the needle hub and projecting distally of the needle hub and into the catheter tube;

a valve for limiting blood backflow positioned in the interior cavity of the catheter hub;

a valve opener having an actuating end for opening the valve positioned proximally of the valve;

a third housing with an exposed third housing exterior surface located between the catheter hub and the needle hub enclosing a tip protector within the third housing for blocking the needle tip, said third housing removeably engaged to the catheter hub in a ready to use position; and

wherein the needle hub and the third housing are in contact with one another in the ready to use position.

23. The catheter assembly according to claim 22, wherein the valve opener further comprises a push end for pushing by a male implement inserted into the catheter hub.

24. The catheter assembly according to claim 22, wherein the valve comprises a cut-out and wherein the actuating end projects into the cut-out to open fluid flow through the valve.

25. The catheter assembly according to claim 22, wherein the tip protector is made from a metal material and is spring loaded against a side of the needle in the ready to use position.

26. The catheter assembly according to claim 25, wherein the tip protector comprises a distal wall section for blocking the needle tip in a protective position.

27. A catheter assembly comprising:

a catheter hub comprising a housing comprising an exterior surface and an interior surface defining a cavity having a catheter tube attached thereto and extending distally of the catheter hub;

a needle hub comprising a housing having a needle having a needle tip attached thereto and projecting distally thereof and into the catheter tube;

a valve having a cut-out for limiting blood backflow positioned in the interior cavity of the catheter hub;

a valve opener having an actuating end for engaging the cut-out and opening the valve, the valve opener being positioned proximally of the valve; and

a third housing with an exposed third housing exterior surface located between the catheter hub and the needle hub enclosing a tip protector spring loaded against a side of the needle for blocking the needle tip, said third housing being self-activatingly and removeably engaged to the catheter hub from a ready to use position to a protected position.

28. The catheter assembly according to claim 27, wherein the tip protector comprises a distal wall section for blocking the needle tip in a protective position.

29. The catheter assembly according to claim 27, wherein the valve opener further comprises a push end for pushing by a male implement inserted into the catheter hub.

30. The catheter assembly according to claim 27, wherein the needle comprises a non-uniform outer diameter section near the needle tip.