Catheter insertion device

• US 10,166,370 B2
• Filed: 06/08/2018
• Issued: 01/01/2019
• Est. Priority Date: 07/04/2002
• Status: Expired due to Term

• 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, Raines, Kenneth C.
• Primary Examiner(s): Mehta, Bhisma
• Assistant Examiner(s): Darb, Hamza
• Application Number:
  US16/004,211
• Publication Number:
  US 20180289931A1
• Time in Patent Office: 207 Days
• CPC Class Codes: A61B 17/3415 for introducing tubes or catheters, e.g. gastrostomy tubes, drain catheters A61B17/3417 takes precedence; body piercing catheter guide needles A61M25/06
• CPC Class Codes: A61M 2005/325 Means obstructing the needle passage at distal end of a needle protection sleeve
• CPC Class Codes: A61M 25/0097 characterised by the hub connectors A61M39/10
• 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 39/0606 without means for adjusting the seal opening or pressure A61M39/0693 takes precedence
• CPC Class Codes: A61M 39/0693 including means for seal penetration
• CPC Class Codes: A61M 39/221 Frangible or pierceable closures within tubing A61M39/14 takes precedence; frangible closures for containers A61J1/14
• 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

Embodiments of a catheter insertion device are discussed comprising: an approximately hollow cylindrical catheter sleeve, at whose distal end a catheter is attached; a needle sleeve with a hollow needle, which is attached thereto and which, when ready for use, extends through the catheter sleeve and the catheter, and; a needle protective element that is arranged inside the catheter sleeve while being able to move on the needle. Said needle protective element has an engaging section that engages with an engaging device, which is formed in the vicinity of the needle tip, when the hollow needle is withdrawn from the catheter sleeve. A check valve is placed inside the catheter sleeve between the catheter and the needle protective element. The hollow needle, when ready for use, extends through said check valve, and the check valve automatically closes once the needle is withdrawn.

Claims

1. A catheter insertion device comprising:

a catheter hub comprising a body having an interior surface defining a bore with a Luer taper, a shoulder inside the bore and distal of a proximal opening to the bore, and a catheter tube attached at a distal end of the catheter hub;

a valve comprising at least one slit located inside the bore of the catheter hub for limiting fluid flow through the bore and remaining inside the bore in a ready position and a needle guarded position;

a valve actuator slidably disposed in the bore of the catheter hub;

said valve actuator comprising a nose section, a bore, a projection extending radially of a lengthwise axis of the valve actuator, and a plunger section comprising plunger components located proximally of the nose section, said plunger section comprising a gap between the plunger components to permit fluid flow through the gap and the bore of the valve actuator, wherein said plunger section comprises an abutting surface at a proximal end for pushing by a male Luer tip when said male Luer tip is located in said bore of said catheter hub;

a needle having a needle shaft defining a needle axis projecting distally of an end of a needle hub and through the catheter tube with a needle tip of the needle shaft extending out a distal end opening of the catheter tube; and

a needle guard comprising a surface for guarding the needle tip from unintended needle sticks when the needle tip is removed from the catheter hub, said surface of the needle guard being located to a side of the needle shaft in the ready position and being located distal of the needle tip in the needle guarded position to guard the needle tip.

2. The catheter insertion device of claim 1, wherein the bore of the valve actuator extends through the nose section and the needle shaft is located in the bore that extends through the nose section in the ready position.

3. The catheter insertion device of claim 2, wherein the valve actuator and the needle are slidable relative to one another.

4. The catheter insertion device of claim 3, wherein the needle guard and the needle are slidable relative to one another.

5. The catheter insertion device of claim 1, wherein the needle guard is biased by the side of the needle shaft in the ready position.

6. The catheter insertion device of claim 1, wherein the needle comprises a lateral projection for engaging a perimeter defining an opening on a proximal wall of the needle guard.

7. The catheter insertion device of claim 1, wherein the catheter hub comprises a first hub section attached to a second hub section.

8. The catheter insertion device of claim 1, wherein the valve comprises the at least one slit comprising three slits defining three flaps.

9. A method for assembling a catheter insertion device comprising:

forming a catheter hub comprising a body having an interior surface defining a bore with a female Luer, a shoulder on the interior surface and distal of a proximal opening to the bore, and a catheter tube attached at a distal end of the catheter hub;

positioning a valve with at least one slit inside the bore of the catheter hub for blocking fluid flow through the bore, said valve being located inside the bore in a ready position and in a needle guarded position;

positioning a valve actuator having a lengthwise axis slidingly in the bore of the catheter hub;

said valve actuator comprising a nose section, a bore, a projection extending radially of the lengthwise axis, and a plunger section located proximally of the nose section and wherein said plunger section comprises a gap to permit fluid flow to flow through the gap and through the bore of the valve actuator;

projecting a needle having a needle shaft defining a needle axis distally of an end of a needle hub and projecting the needle shaft through the catheter tube and the at least one slit so that a needle tip of the needle extends out a distal opening of the catheter tube;

mounting a needle guard around said needle such that said needle guard and said needle are slidable relative to one another;

wherein said needle guard comprises a surface for guarding the needle tip from unintended needle sticks when the needle tip is removed from the catheter hub; and

wherein the nose section of the valve actuator is slidable into the valve to open the at least one slit when a male Luer tip is located in said bore of said catheter hub and pushing distally against an abutting surface at a proximal end of the valve actuator.

10. The method of claim 9, wherein the catheter hub comprises a push tab on an exterior of the body.

11. The method of claim 9, wherein the plunger section comprises two spaced apart plunger components.

12. The method of claim 9, wherein the surface of the needle guard is located to a side of the needle in the ready position.

13. The method of claim 12, wherein the needle and the needle guard are movable relative to one another so that the surface is distal of the needle tip in the needle guarded position to guard the needle tip.

14. The method of claim 9, wherein the bore of the catheter hub comprises a groove and wherein the valve actuator is positioned at least in part in the groove.

15. The method of claim 9, wherein the needle guard is located distally of the proximal opening of the catheter hub.

16. The method of claim 9, further comprising moving the nose section of the valve actuator into the valve by positioning a male Luer tip in the proximal opening of the bore of the catheter hub.

17. The method of claim 16, further comprising removing the male Luer tip from the proximal opening of the bore of the catheter hub for allowing the valve to close.

18. A catheter insertion device comprising:

a catheter hub comprising a body with an interior defining a bore having a female Luer at a proximal end and an internal shoulder;

a catheter tube with a distal end opening, said catheter tube attached to and extending distally of the catheter hub;

a needle having a needle shaft with a needle tip, said needle shaft projecting distally of an end of a needle hub and through the catheter tube with the needle tip located distally of the distal end opening of the catheter tube;

a valve with at least one slit sized and shaped to obstruct fluid flow, said valve being positioned inside the bore of the catheter hub and remaining inside the bore of the catheter hub when the needle is removed from the catheter hub;

a valve actuator having a lengthwise axis slidingly disposed in the bore of the catheter hub to actuate the valve, the valve actuator comprising a nose section structured to push the valve to open the at least one slit, wherein said valve actuator comprises a bore and a plunger section located proximally of the nose section, said plunger section comprising spaced apart plunger components having a gap to permit fluid flow to flow through the plunger components and the bore of the valve actuator;

a needle guard located proximally of the nose section, said needle guard comprising a surface located to a side of the needle shaft in the ready position and the needle guard and the needle movable relative to one another so that the surface is distal of the needle tip in a protected position to guard the needle tip from unintended needle sticks; and

wherein the plunger section comprises an actuating surface that is exposed for abutting by a male Luer tip after the needle guard is removed with the needle from the catheter hub.

19. The catheter insertion device of claim 18, wherein the needle guard is located at least in part inside the bore of the catheter hub.

20. The catheter insertion device of claim 19, wherein the needle guard comprises two resilient arms.

21. The catheter insertion device of claim 20, wherein the needle guard is located between the spaced apart plunger components.

22. The catheter insertion device of claim 20, further comprising a radial projection on the needle for engaging a proximal wall on the needle guard when the needle is removed from the catheter hub.

23. The catheter insertion device of claim 18, wherein the nose section of the valve actuator has an exterior surface and a projection projects radially of the valve actuator and abuts the internal shoulder in the bore of the catheter hub.

24. The catheter insertion device of claim 18, wherein the valve actuator is slidable distally when pushed by a male Luer tip and is slidable proximally when the male Luer tip is removed.

25. The catheter insertion device of claim 18, further comprising a groove and wherein the valve actuator is disposed at least in part in the groove.

26. A catheter insertion device comprising:

a catheter hub comprising a body with an interior defining a bore having a female Luer at a proximal end, a groove, and a shoulder;

a catheter tube comprising a distal end opening, said catheter tube extending distally of the catheter hub;

a needle having a needle shaft with a needle tip, said needle projecting distally of an end of a needle hub and through the catheter tube with the needle tip located distally of the distal end opening of the catheter tube in a ready position;

a valve with at least one slit positioned inside the bore of the catheter hub, said valve having a surface to obstruct fluid flow and remaining inside the bore of the catheter hub when the needle is removed from the catheter hub;

a valve actuator having a lengthwise axis slidingly disposed in the bore of the catheter hub to actuate the valve, the valve actuator comprising a nose section structured to push the valve to open the at least one slit, a bore, and a plunger section comprising spaced apart plunger components extending proximally of the nose section and having a gap to permit fluid flow through the plunger components and the bore of the valve actuator;

a needle guard comprising a surface mounted with the needle so that the needle tip is guarded by the surface of the needle guard when the needle tip is moved from the ready position to a protected position; and

wherein the plunger section is guided distally within the groove when a male Luer tip is positioned in the bore of the catheter hub and pushing against an abutting surface at a proximal end of the valve actuator.

27. The catheter insertion device of claim 26, wherein the needle guard is located at least in part inside the bore of the catheter hub.

28. The catheter insertion device of claim 27, wherein the needle guard comprises an arm that is movable relative to the needle.

29. The catheter insertion device of claim 28, wherein a projection on the valve actuator is located distally of the shoulder in the bore of the catheter hub.

30. The catheter insertion device of claim 26, wherein the needle guard is located between the spaced apart plunger components.