Catheter assembly and components thereof

• US 9,370,641 B2
• Filed: 10/24/2013
• Issued: 06/21/2016
• 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:
  US14/062,081
• Publication Number:
  US 20140052065A1
• Time in Patent Office: 971 Days
• Field of Search: 604/96.01
• US Class Current: 1/1
• 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 safety 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, the opening at the proximal end having a Luer taper;

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 for obstructing fluid flow positioned inside the interior cavity of the first hub;

a valve actuating element slidingly disposed in the first hub for actuating the valve; and

a third hub positioned between the first hub and the second hub having a needle protective device positioned therein in a ready position in which the needle tip is exposed and sized and shaped to prevent unintended needle sticks in a protective position; and

wherein the protective device is made from a metallic component.

2. The safety catheter assembly of claim 1, wherein the third hub comprises a generally cylindrical cylinder.

3. The safety catheter assembly of claim 1, wherein the valve comprises three slits that converge at a single point.

4. The safety catheter assembly of claim 1, wherein the protective device comprises a proximal wall and an arm extending distally of the proximal wall.

5. The safety catheter assembly of claim 1, wherein the valve actuating element comprises a projection located proximally of a tapered nose section and projects radially outwardly of the nose section and engaging a shoulder of the first hub.

6. The safety catheter assembly of claim 1, wherein the valve comprises one or more ridges along an outer surface to permit venting around the outer surface of the valve.

7. The safety catheter assembly of claim 1, wherein the needle shaft comprises a nominal diameter and wherein the needle shaft has a change in the nominal diameter adjacent the needle tip.

8. A catheter assembly comprising:

a catheter hub comprising a housing comprising an exterior surface and an interior surface defining a cavity having an opening for receiving a Luer connector and a catheter tube extending distally of the catheter hub;

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

a valve for limiting blood backflow positioned in the interior cavity of the catheter hub in a ready position in which the needle tip extends distally of a distal opening of the catheter tube and after the needle is removed from the catheter hub; and

a third housing located between the catheter hub and the needle hub enclosing a tip protector for blocking the needle tip in a protective position, said valve and said third housing are movable relative to one another.

9. The catheter assembly according to claim 8, wherein the tip protector comprises a distal wall section for blocking the needle tip in the protective position.

10. The catheter assembly according to claim 8, further comprising a valve opener comprising a push end for pushing by a male implement inserted into the catheter hub.

11. The catheter assembly according to claim 8, wherein the needle comprises a non-uniform outer diameter section near the needle tip.

12. The catheter assembly according to claim 8, wherein the valve has an outer circumference in abutting contact with the interior surface of the catheter hub.

13. The catheter assembly according to claim 8, wherein an arm extends distally of the third housing and removably contacts the catheter hub.

14. The catheter assembly according to claim 10, wherein the valve actuating element is retained inside the catheter hub by a shoulder.

15. A safety catheter assembly comprising:

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

said catheter hub having a catheter tube attached to a distal end of the catheter hub and the catheter tube comprising a distal opening;

a needle hub having a needle with a needle tip attached to the needle hub and projecting distally of the needle hub and into the catheter tube with the needle tip extending out the distal opening of the catheter tube;

a valve for limiting fluid flow and a valve opener in cooperative arrangement therewith positioned in the interior cavity of the catheter hub;

a safety device for covering the needle tip comprising a tip protector housing having a housing section positioned proximally of a proximal end of the catheter hub; and

wherein the valve opener comprises two proximally extending legs having a gap therebetween, the two proximally extending legs being sized and shaped to be pushed distally towards the valve to transfer a force imparted by a male Luer to the valve.

16. The safety catheter assembly according to claim 15, wherein the valve comprises a skirt section and one or more ridges along an outer surface thereof to permit venting around the skirt section.

17. The safety catheter assembly according to claim 15, wherein the valve comprises one or more slits that are deflectable by a distal end of the valve opener.

18. The safety catheter assembly according to claim 17, wherein the distal end of the valve opener comprises a nose section having a frusto-conical shape for projecting through the slits.

19. The safety catheter assembly according to claim 15, wherein the safety device for covering the needle tip comprises a movable resilient member completely surrounded by a hollow cylinder of the tip protector housing.

20. The safety catheter assembly according to claim 18, wherein the safety device for covering the needle tip comprises a resilient portion made from a metal material and the tip protector housing surrounding the resilient portion.

21. The safety catheter assembly of claim 19, wherein the safety device for covering the needle tip comprises an arm extending into an open proximal end of the catheter hub.

22. The safety catheter assembly according to claim 15, wherein the valve opener comprises an actuating end for opening the valve and one or more legs extending proximally of the actuating end.

23. The safety catheter assembly according to claim 22, wherein the actuating end comprises an undulating surface or barbs for gripping engagement with the valve.

24. The safety catheter assembly according to claim 15, wherein the safety device for covering the needle tip comprises a proximal wall having an opening and two arms each having a distal wall for blocking the needle tip.

25. A safety catheter assembly comprising:

a catheter hub comprising a housing comprising an exterior surface and an interior surface defining an interior cavity having an interior shoulder and an open proximal end;

a catheter tube attached to a distal end of the catheter hub and having a distal opening;

a needle hub having a needle with a needle tip attached to the needle hub and projecting distally of the needle hub and into the catheter tube with the needle tip extending out the distal opening;

a valve for limiting fluid flow and a valve opener in cooperative arrangement therewith positioned in the interior cavity of the catheter hub, said valve opener comprising a projection abutting the interior shoulder of the catheter hub;

a safety device for covering the needle tip comprising a tip protector housing having a housing section positioned proximally of the catheter hub and a projection positioned at least in part in the open proximal end of the catheter hub; and

at least two proximally extending legs having a gap therebetween of the valve opener being sized and shaped to be pushed distally to transfer a distally directed force to the valve to open one or more slits on the valve.

26. The safety catheter assembly according to claim 25, wherein the tip protector housing surrounds a tip protector and the tip protector housing is located externally and proximally of the open proximal end of the catheter hub.

27. The safety catheter assembly according to claim 25, wherein the projection is an arm extending distally of the housing section and into the open proximal end of the catheter hub.

28. The safety catheter assembly according to claim 27, wherein the safety device for covering the needle tip comprises a resilient portion made from a metal material and the tip protector housing surrounding the resilient portion.

29. The safety catheter assembly according to claim 26, wherein the tip protector comprises a proximal wall having an opening and one or more arms having at least one distal wall for blocking the needle tip.

30. The safety catheter assembly according to claim 28, wherein the valve comprises a skirt section and one or more ridges along an outer surface thereof to permit venting around the skirt section.