Needleless medical connector having antimicrobial agent

• US 20020133124A1
• Filed: 05/08/2002
• Published: 09/19/2002
• Est. Priority Date: 07/27/1999
• Status: Active Grant

• Current Assignee: Carefusion 303 Incorporated (Becton, Dickinson & Co)
• Original Assignee: Cardinal Health 303 Incorporated (Cardinal Health, Inc.)
• Inventors: Mosler, Theodore J., Leinsing, Karl R.
• Granted Patent: US 7,184,825 B2
• Time in Patent Office: Days
• US Class Current: 604/256
• CPC Class Codes: A61M 2039/263 where the fluid space within the valve is decreasing upon disconnection
• CPC Class Codes: A61M 39/26 Valves closing automatically on disconnecting the line and opening on reconnection thereof check valves A61M39/24

Abstract

A needleless connector for medical use, adapted to facilitate the flow of fluid therethrough, includes a housing having an inlet port and an outlet port. The connector also includes a flex-tube assembly defining a fluid path between the inlet port and the outlet port. The flex-tube assembly is movable between uncompressed and compressed states. The flex-tube assembly has a first internal volume when in the uncompressed state and a second internal volume, greater than or substantially equal to the first internal volume, when in the compressed state.

Claims

1. A needleless connector for medical use, adapted to facilitate the flow of fluid therethrough, said connector comprising:

a housing having an inlet port and an outlet port; and

a flex-tube assembly defining a fluid path between the inlet port and the outlet port, the flex-tube assembly movable between uncompressed and compressed states, the flex-tube assembly having a first internal volume when in the uncompressed state and a second internal volume, at least as great as the first internal volume, when in the compressed state.

2. The connector of claim 1 wherein the second internal volume is greater than the first internal volume.

3. The connector of claim 1 wherein the second internal volume is substantially equal to the first internal volume

4. The connector of claim 1 wherein the flex-tube assembly comprises:

an inlet end positioned within the inlet port during the uncompressed state and outside the inlet port during the compressed state; and

a bore carried by the inlet end, the bore closed when the inlet end is within the inlet port and opened when the inlet end is outside the inlet port.

5. The connector of claim 1 wherein the flex-tube assembly comprises:

a flex-tube insert having at least one collapsible section movable between uncollapsed and collapsed states; and

a flex-tube piston surrounding the flex-tube insert and defining the fluid path, the flex-tube piston including a piston head positioned within the inlet port during the uncompressed state and outside the inlet port during the compressed state, a bore carried by the piston head, the bore closed when the piston head is within the inlet port and opened when the piston head is outside the inlet port, and a piston base proximal the outlet port and in communication therewith, the flex-tube piston responsive to the movement of the flex-tube insert.

6. The connector of claim 5 wherein the flex-tube insert is formed of a substantially rigid material and the flex-tube piston is formed of a resiliently deformable material.

7. The connector of claim 5 wherein the flex-tube insert has a first maximum width when uncollapsed and a second maximum width, greater than the first maximum width, when collapsed, the width defined by the maximum cross section of the flex-tube insert when viewed along the axis of the fluid path.

8. The connector of claim 5 wherein each collapsible section comprises:

a first end;

a second end; and

a plurality of hinge assemblies each having a hinge and two plates including two substantially parallel edges, one of the edges attached to the hinge for pivotal movement and the other of the edges attached to one of either the first or second ends for pivotal movement.

9. The connector of claim 5 wherein the flex-tube insert comprises one collapsible section and the first end is secured within the piston head and the second end is secured within the piston base.

10. The connector of claim 5 wherein the flex-tube insert comprises:

two collapsible sections; and

a middle support for joining the two collapsible sections;

wherein for one collapsible section, the first end is secured within the piston head and the second end is pivotably attached to the middle support, and wherein for the other collapsible section, the first end is pivotably attached to the middle support and the second end is secured within the piston base.

11. The connector of claim 8 wherein there are four hinge assemblies arranged so that the flex-tube insert has a substantially square cross section when viewed along the axis of the fluid path.

12. The connector of claim 1 wherein the flex-tube assembly comprises:

at least one collapsible section defining the fluid path;

a piston head positioned within the inlet port during the uncompressed state and outside the inlet port during the compressed state;

a bore carried by the piston head, the bore closed when the piston head is within the inlet port and opened when the piston head is outside the inlet port;

a piston base proximal the outlet port and in communication therewith.

13. The connector of claim 12 wherein, when viewed along the axis of the fluid path, the flex-tube assembly has a first maximum cross-sectional area when uncollapsed and a second maximum cross-sectional area, greater than the first maximum cross-sectional area, when collapsed.

14. The connector of claim 12 wherein each collapsible section comprises:

a first end;

a second end;

a plurality of hinge assemblies each having a hinge and two plates including two substantially parallel edges, one of the edges attached to the hinge for pivotal movement and the other of the edges attached to one of either the first or second ends for pivotal movement; and

a plurality of resiliently deformable webs joining the edges of adjacent hinge assemblies to enclose the fluid path.

15. The connector of claim 14 wherein the hinge assemblies and the webs are formed of the same material and the webs are thinner than the hinge assemblies.

16. The connector of claim 12 wherein the flex-tube assembly comprises one collapsible section and the first end comprises the piston head and the second end comprises the piston base.

17. The connector of claim 12 wherein the flex-tube assembly comprises:

two collapsible sections; and

a middle support for joining the two collapsible sections;

wherein for one collapsible section, the first end comprises the piston head and the second end is pivotably attached to the middle support, and wherein for the other collapsible section, the first end is pivotably attached to the middle support and the second end comprises the piston base.

18. The connector of claim 1 wherein the housing comprises:

a valve body with a first set of geometrically-shaped snap-fit devices defined by a first set of dimensions; and

a male Luer-lock insert with a second set of geometrically-shaped snap-fit devices also defined by the first set of dimensions but complementary to the first set of devices;

wherein the first and second set of snap-fit devices are aligned to provide snap-fit assembly of the valve body and male Luer-lock insert.

19. The connector of claim 18 wherein the first set of devices are recesses and the second set of devices are protrusions.

20. A valve for providing a fluid path between the inlet port and outlet port of a connector, said valve comprising:

a flex-tube insert substantially axially aligned with the axis of the fluid path, the insert movable between uncompressed and compressed states, the insert having a first maximum inner width while uncompressed and a second maximum inner width, greater than the first maximum inner width, while compressed; and

a flex-tube piston surrounding the flex-tube insert and defining the radial boundaries of the fluid path, the flex-tube piston including a piston head for positioning within the inlet port during the uncompressed state and outside the inlet port during the compressed state, a bore carried by the piston head, the bore closed when the piston head is within the inlet port and opened when the piston head is outside the inlet port, and a piston base for positioning proximal the outlet port and providing fluid communication with the outlet port, the flex-tube piston responsive to movement of the flex-tube insert.

21. The valve of claim 20 wherein the flex-tube insert comprises at least one collapsible section having a maximum cross section when viewed along the axis of the fluid path, the maximum cross section defining the first and second maximum inner widths.

22. The connector of claim 21 wherein each collapsible section comprises:

a first end;

a second end; and

a plurality of hinge assemblies each having a hinge and two plates including two substantially parallel edges, one of the edges attached to the hinge for pivotal movement and the other of the edges attached to one of either the first or second ends for pivotal movement.

23. The valve of claim 22 wherein there are four hinge assemblies arranged so that the flex-tube insert has a substantially square cross section when viewed along the axis of the fluid path and the distance between opposing hinges of the hinge assemblies define the first and second maximum cross sections.

24. The connector of claim 21 wherein the flex-tube insert comprises one collapsible section and the first end is secured within the piston head and the second end is secured within the piston base.

25. The connector of claim 21 wherein the flex-tube insert comprises:

two collapsible sections; and

a middle support having a bore therethrough axially aligned with the fluid path, the middle support for joining the two collapsible sections;

wherein for one collapsible section, the first end is secured within the piston head and the second end is pivotably attached to the middle support, and wherein for the other collapsible section, the first end is pivotably attached to the middle support and the second end is secured within the piston base.

26. The valve of claim 20 wherein at least one of the insert and the piston is formed to include an antimicrobial agent.

27. The valve of claim 26 wherein the antimicrobial agent is chosen from materials consisting of silver, silver oxide and silver sulfadiazine.

29. The valve of claim 28 wherein the collapsible section comprises at least one collapsible portion having a maximum cross-sectional area when viewed along the axis of the fluid path, the maximum cross-sectional area defining the first and second maximum cross-sectional areas.

30. The connector of claim 29 wherein each collapsible portion comprises:

a first end;

a second end;

a plurality of hinge assemblies each having a hinge and two plates including two substantially parallel edges, one of the edges attached to the hinge for pivotal movement and the other of the edges attached to one of either the first or second ends for pivotal movement; and

a plurality of resiliently deformable webs joining the edges of adjacent hinge assemblies to seal the interior of the collapsible section.

31. The valve of claim 30 wherein there are three hinge assemblies arranged so that the collapsible portion has a substantially triangular cross section when viewed along the axis of the fluid path.

32. The valve of claim 30 wherein there are two hinge assemblies arranged so that the collapsible portion has a substantially rectangular cross section when viewed along the axis of the fluid path.

33. The connector of claim 29 wherein the collapsible section comprises one collapsible portion and the first end comprises the piston head and the second end comprises the piston base.

34. The connector of claim 29 wherein the collapsible section comprises:

two collapsible portions; and

a middle support having a bore therethrough axially aligned with the fluid path, the middle support for joining the two collapsible portions;

wherein for one collapsible portion, the first end comprises the piston head and the second end comprises the middle support, and wherein for the other collapsible portion, the first end also comprises the middle support and the second end comprises the piston base.

35. The valve of claim 28 wherein at least one of the collapsible section, the piston head and piston base is formed to include an antimicrobial agent.

36. The valve of claim 35 wherein the antimicrobial agent is chosen from materials consisting of silver, silver oxide and silver sulfadiazine.

38. The method of claim 37 wherein the valve assembly is formed of a resiliently deformable material and the step of increasing the internal volume of the fluid path while opening the bore comprises the steps of:

displacing the inlet end from the inlet port; and

expanding the valve assembly in a generally radial outward direction relative to the axis of the fluid flow path.

39. The method of claim 38 wherein the step of displacing the inlet end from the inlet port comprises the step of inserting a male-Luer taper into the inlet port and applying pressure to the inlet end.

40. The method of claim 39 wherein the step of decreasing the internal volume of the fluid path while closing the bore comprises the steps of:

placing the inlet end in the inlet port; and

collapsing the valve assembly in a generally radial inward direction relative to the axis of the fluid flow path.

41. The method of claim 40 wherein the step of placing the inlet end in the inlet port comprises the step of removing the male-Luer taper from the inlet port.

28. A valve for providing a fluid path between the inlet port and outlet port of a connector, said valve comprising:

a collapsible section having a hollow interior defining the radial boundaries of the fluid path, the collapsible section movable between uncompressed and compressed states, the collapsible section having a first maximum cross-sectional area while uncompressed and a second maximum cross-sectional area, greater than the first maximum cross-sectional area, while compressed;

a piston head at one end of the collapsible section for positioning within the inlet port during the uncompressed state and outside the inlet port during the compressed state;

a bore carried by the piston head, the bore closed when the piston head is within the inlet port and opened and communicating with the interior of the collapsible section when the piston head is outside the inlet port; and

a piston base at the other end of the collapsible section for positioning proximal the outlet port and providing communication with the outlet port.

37. A method of controlling the flow of fluid between an inlet port and an outlet port of a medical connector having a valve assembly defining a fluid path having an internal volume, the valve assembly having an inlet end disposed within the inlet port and an outlet end communicating with the outlet port, the inlet end carrying a bore that is closed when within the inlet end and opened when outside the inlet port, said method comprising the steps of:

increasing the internal volume of the fluid path while opening the bore; and

subsequently decreasing the internal volume of the fluid path while closing the bore.

42. A method of controlling the flow of fluid between an inlet port and an outlet port of a medical connector having an axially compressible valve assembly defining a fluid path having an internal volume, the valve assembly having an inlet end disposed within the inlet port and an outlet end communicating with the outlet port, the inlet end carrying a bore that is closed when within the inlet end and opened when outside the inlet port, said method comprising the steps of:

maintaining the internal volume of the fluid path substantially constant while axially compressing the valve assembly and opening the bore; and

subsequently maintaining the internal volume of the fluid path substantially constant while axially decompressing the valve assembly and closing the bore.

43. The method of claim 42 wherein the valve assembly is formed of a resiliently deformable material and the step of maintaining the internal volume of the fluid path substantially constant while axially compressing the valve assembly and opening the bore comprises the steps of:

displacing the inlet end from the inlet port; and

expanding the valve assembly in a generally radial outward direction relative to the axis of the fluid flow path.

44. The method of claim 43 wherein the step of displacing the inlet end from the inlet port comprises the step of inserting a male-Luer taper into the inlet port and applying pressure to the inlet end.

45. The method of claim 44 wherein the step of maintaining the internal volume of the fluid path substantially constant while axially decompressing the valve assembly and closing the bore comprises the steps of:

placing the inlet end in the inlet port; and

collapsing the valve assembly in a generally radial inward direction relative to the axis of the fluid flow path.

46. The method of claim 45 wherein the step of placing the inlet end in the inlet port comprises the step of removing the male-Luer taper from the inlet port.

48. The connector of claim 47 wherein the antimicrobial agent is chosen from materials consisting of silver, silver oxide and silver sulfadiazine.

47. A connector for medical use, adapted to facilitate the flow of fluid therethrough, said connector comprising:

an inlet port;

an outlet port; and

a valve assembly defining a fluid path between the inlet port and the outlet port;

wherein at least one of the inlet port, the outlet port and the valve assembly is formed to include an antimicrobial agent.