CATHETER ASSEMBLY AND COMPONENTS THEREOF

• US 20130060197A1
• Filed: 11/02/2012
• Published: 03/07/2013
• 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
• Granted Patent: US 8,597,249 B2
• Time in Patent Office: Days
• 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 on 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 an interior cavity;

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

a needle hub;

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 tip protector positioned adjacent the valve opener, the tip protector comprising;

a tip protector housing; and

an arm extending from the tip protector housing to engage the interior surface of the catheter hub and retain the tip protector 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 cut-out comprises one or more slits for expanding the cut-out when deflected by the valve opener.

4. The catheter assembly according to claim 2, wherein an air tight seal is formed between the skirt section and the interior surface of the catheter hub.

5. The catheter assembly according to claim 1 wherein the skirt section comprises a plurality of bumps, stretched ridges or protuberances around an external circumference for sufficient air flow between the valve skirt and the inside surface of the catheter hub.

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 barbs 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 6, wherein the valve opener comprises a leg extending proximally of the actuating end.

11. The catheter assembly according to claim 6, wherein the valve opener comprises two legs extending proximally of the actuating end and having a gap therebetween.

12. The catheter assembly according to claim 1, wherein the valve opener is spaced apart from and not in contact with the valve in the ready position.

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

14. The catheter assembly according to claim 1, wherein the needle hub comprises a housing.

15. The catheter assembly according to claim 1, wherein the tip protector is for blocking the needle tip.

16. The catheter assembly according to claim 1, wherein the arm extends from a distal wall of the tip protector.

17. The catheter assembly according to claim 1, wherein the arm retains the tip protector housing to the catheter hub in the ready to use position.

18. The catheter assembly according to claim 1, wherein the needle is without a crimp.

19. The catheter assembly according to claim 1, wherein the tip protector housing comprises a rear plate or panel for closing an opening and allows the tip protector to be placed therein during assembly.

20. The catheter assembly according to claim 1, wherein the tip protector is spring loaded in the ready to use position.

21. The catheter assembly according to claim 1, wherein the tip protector housing is located outside of the catheter hub.

22. A catheter assembly comprising:

a first hub comprising an interior cavity, an opening at a proximal end, and a catheter tube having a distal end opening extending distally of the first hub;

a needle having a needle shaft defining a needle axis projecting distally of an end of a second hub, said needle projecting through the catheter tube and comprising a needle tip;

a valve comprising a slit for obstructing fluid flow and a skirt section positioned inside the interior cavity of the first hub such that the skirt section contacts the interior cavity of the first hub;

said valve remaining inside the interior cavity when the needle is removed from the catheter tube and the first hub;

a valve opener disposed in the first hub for actuating the valve, the valve opener comprising a nose section for pushing the valve to open the slit when activated and leg element extending proximally of the nose section;

wherein the leg element is slidable distally within the interior cavity of the first hub by a male implement to transfer a distally directed force to the nose section to push the valve to open the slit;

a needle protective device spring loaded in a ready to use position and positioned proximally of the valve and at least in part around the needle to prevent unintended contact with the needle tip in a protective position; and

a third hub positioned substantially proximally of the first hub.

23. The catheter assembly of claim 22, further comprising a plurality of stretched ridges or protuberances around an external circumference of the skirt section for sufficient air flow between the skirt section and an inside surface of the first hub.

24. The catheter assembly of claim 22, wherein the first hub comprises a shoulder in the interior cavity and the valve opener comprises a projection in contact with the shoulder.

25. The catheter assembly of claim 22, further comprising a second leg element spaced from the leg element for fluid flow therebetween.

26. The catheter assembly of claim 22, wherein the needle protective device is positioned adjacent the leg element.

27. A safety catheter assembly comprising:

a first hub comprising an interior cavity comprising a shoulder, an opening at a proximal end, and a catheter tube attached thereto and extending from a distal end;

a needle attached to a second hub, said needle having a needle shaft with a generally constant outer diameter from a proximal end along a length of the shaft to just proximal of a tapered section of a needle tip;

said needle shaft defining a needle axis projecting through the catheter tube;

a valve to obstruct fluid flow comprising a cut-out positioned inside the interior cavity of the first hub;

said valve remaining inside the interior cavity of the first hub when the needle is removed from the catheter tube and the first hub;

a valve opener slidingly disposed in the first hub to open the cut-out and to remain engaged to the valve, the valve opener comprising a nose section having a tapered end, a projection located proximally of the tapered nose section engaging the shoulder of the first hub, and a leg structured to slide distally to transfer a distally directed force to the nose section to open the valve;

a needle protective device spring loaded in a ready to use position and positioned proximally of the valve and at least in part around the needle in the ready position;

said needle protective device springing to a protective position to prevent unintended contact with the needle tip; and

a third hub comprising an arm extending distally into the first hub in the ready position.

28. The catheter assembly of claim 27, further comprising a plurality of stretched ridges or protuberances around an external circumference of a skirt section of the valve for sufficient air flow between the skirt section and an inside surface of the first hub.

29. The catheter assembly of claim 27, further comprising a second leg spaced from the leg for fluid flow therebetween.

30. The catheter assembly of claim 27, herein the cut-out comprises three slits for permitting fluid flow when opened.