Axially engaging medical connector system with fluid-resistant mating interfaces

• US 10,156,306 B2
• Filed: 02/20/2018
• Issued: 12/18/2018
• Est. Priority Date: 09/09/2011
• Status: Active Grant

• Current Assignee: ICU Medical Incorporated
• Original Assignee: ICU Medical Incorporated
• Inventors: Fangrow, Thomas F.
• Primary Examiner(s): Arundale, R. K.
• Assistant Examiner(s): WADDY, JONATHAN J
• Application Number:
  US15/900,658
• Publication Number:
  US 20180172190A1
• Time in Patent Office: 301 Days
• Field of Search: 137614, 13761404, 2511491
• CPC Class Codes: A61M 2039/1027 Quick-acting type connectors
• CPC Class Codes: A61M 2039/1033 Swivel nut connectors, e.g. threaded connectors, bayonet-connectors
• CPC Class Codes: A61M 2039/1066 having protection means, e.g. sliding sleeve to protect connector itself, shrouds to protect a needle present in the connector, protective housing, isolating sheath
• CPC Class Codes: A61M 2039/262 having a fluid space within the valve remaining the same upon connection and disconnection, i.e. neutral-drawback valve
• CPC Class Codes: A61M 2039/263 where the fluid space within the valve is decreasing upon disconnection
• CPC Class Codes: A61M 2039/267 having a sealing sleeve around a tubular or solid stem portion of the connector
• CPC Class Codes: A61M 39/1011 Locking means for securing connection; Additional tamper safeties A61M39/16 takes precedence
• CPC Class Codes: A61M 39/18 Methods or apparatus for making the connection under sterile conditions, i.e. sterile docking
• CPC Class Codes: A61M 39/26 Valves closing automatically on disconnecting the line and opening on reconnection thereof check valves A61M39/24
• CPC Class Codes: F16L 29/00 Joints with fluid cut-off means quick-acting joints with cut-off means F16L37/28
• CPC Class Codes: F16L 29/04 with a cut-off device in each of the two pipe ends, the cut-off devices being automatically opened when the coupling is applied
• CPC Class Codes: F16L 37/34 at least one of the lift valves being of the sleeve type, i.e. a sleeve is telescoped over an inner cylindrical wall
• CPC Class Codes: F16L 37/35 at least one of the valves having an axial bore

Abstract

A connector system for medical fluid includes a male connector and a female connector that have a closed configuration when detached from one another. The first end of the male connector is configured to mate with a first end of the female connector. When the male connector is coupled with the female connector, complementary structures engage to move seals away from ports in the male connector and the female connector, opening a fluid pathway through the connectors. The mating ends of the connectors are not exposed to the medical fluid when the connectors are coupled so that when the connectors are disconnected, the mating ends are substantially free of residual medical fluid.

Claims

1. A medical connector system configured to facilitate medical fluid transfer and containment, the medical connector system comprising:

a first medical connector comprising;

a first region and a second region, the first region being positioned in a proximal direction from the second region, the first region of the first medical connector being rotatable with respect to the second region of the first medical connector in a stage of use of the first medical connector;

a male portion comprising a deformable tip seal disposed at a distal end of the male portion and extending proximally along an internal surface of the male portion;

an engagement structure; and

a valve member with a first mating surface, the valve member being moveable within the male portion of the first medical connector between a closed position and an opened position, a portion of the valve member contacting the tip seal in the closed position and the valve member being configured to be moved proximally within the male portion into the opened position, the valve member being biased toward the closed position and the tip seal being exposed to a region outside of the first medical connector in the closed position; and

a second medical connector comprising;

a housing with a proximal region and a proximal opening;

an engagement portion on an external surface of the housing;

a fluid conduit with a second mating surface; and

a seal element moveable between a closed configuration and an opened configuration;

wherein the first and second medical connectors are configured to be coupled by axially moving the first and second medical connectors together without requiring rotation, the tip seal of the first medical connector wiping the fluid conduit of the second medical connector, and the engagement structure of the first medical connector advancing over the proximal region of the housing of the second medical connector and the male portion of the first medical connector advancing into the proximal opening of the housing of the second medical connector until the engagement structure of the first medical connector engages with the engagement portion on the second medical connector; and

wherein the first mating surface of the valve member of the first medical connector and the second mating surface of the fluid conduit of the second medical connector engage in a manner that resists fluid penetration between the first and second mating surfaces during engagement.

2. The medical connector system of claim 1, wherein one of the first or second mating surfaces includes a protrusion and the other of the first or second mating surfaces includes a recess that corresponds in size and shape to the protrusion.

3. The medical connector system of claim 1 further comprising a release structure configured to release the engagement structure of the first medical connector from the engagement portion of the second medical connector, enabling the first medical connector to be decoupled from the second medical connector.

4. The medical connector system of claim 3, wherein the release structure is a button.

5. The medical connector system of claim 1, wherein after the first medical connector is decoupled from the second medical connector there is no residual fluid on the first or second mating surfaces.

6. The medical connector system of claim 1, wherein any negligible amount of residual fluid remaining on an external surface of either of the first or second medical connectors after decoupling is small enough as to present no significant functional disadvantages or health hazards in the particular application in which the connector system is employed.

7. The medical connector system of claim 1, wherein the male portion is not a luer.

8. The medical connector system of claim 7, wherein the proximal opening of the housing of the second medical connector is not luer-compatible.

9. The medical connector system of claim 1, wherein the male portion is a luer.

10. The medical connector system of claim 9, wherein the proximal opening of the housing of the second medical connector is luer-compatible.

11. The medical connector system of claim 1, wherein the valve member has an internal fluid pathway configured to receive medical fluid.

12. The medical connector system of claim 1 further comprising a shroud on the first medical connector.

13. The medical connector system of claim 12, wherein the engagement structure of the first medical connector is part of the shroud.

14. The medical connector system of claim 13, wherein the shroud of the first medical connector extends completely around the male portion.

15. The medical connector system of claim 1, wherein the engagement structure of the first medical connector comprises a movable hook.

16. The medical connector system of claim 15, wherein the engagement portion of the second medical connector comprises a channel.

17. The medical connector system of claim 16 further comprising a release structure configured to release the engagement structure of the first medical connector from the engagement portion of the second medical connector, wherein the release structure comprises a tab configured to release the hook from the channel.

18. The medical connector system of claim 17, wherein the first medical connector comprises a shroud having a continuous circular band at a distal end of the first medical connector.

19. The medical connector system of claim 18, wherein the first medical connector comprises a spring to bias the valve member toward the closed position.

20. A closed medical connector system configured to facilitate medical fluid transfer and containment, the closed medical connector system comprising:

a first medical connector comprising;

a first region and a second region, the first region being positioned in a proximal direction from the second region, the first region of the first medical connector being rotatable with respect to the second region of the first medical connector in a stage of use of the first medical connector;

the second region comprising a shroud and a male portion, the shroud comprising an engagement structure and a release structure, and the male portion comprising a deformable tip seal disposed at a distal end of the male portion and extending proximally along an internal surface of the male portion, the tip seal being exposed to a region outside of the first medical connector in the closed configuration; and

a valve member with a distal mating surface, the valve member being moveable within the male portion of the first medical connector between a closed position and an opened position, a portion of the valve member being disposed within the tip seal in the closed position and the valve member being configured to be moved proximally within the male portion into the opened position, the valve member being biased toward the closed position; and

a second medical connector comprising;

a housing with a proximal region and a proximal opening;

an engagement portion on an external surface of the housing;

a fluid conduit with a proximal mating surface; and

a seal element moveable between a closed configuration and an opened configuration, the proximal mating surface of the fluid conduit being exposed to the region outside of the housing in the closed configuration,

wherein the first and second medical connectors are configured to be securely attached together by moving the first and second medical connectors toward each other in a substantially linear motion without requiring rotation, the tip seal of the first medical connector wiping the fluid conduit of the second medical connector, and the shroud of the first medical connector advancing over the proximal region of the housing of the second medical connector until the engagement structure of the first medical connector engages with the engagement portion on the second medical connector, such that relative rotation of the first and second medical connectors is permitted while the first and second medical connectors are securely attached together without disengaging the first and second medical connectors from each other, and

wherein the size and shape of the distal mating surface of the valve member of the first medical connector corresponds with the size and shape of the proximal mating surface of the fluid conduit of the second medical connector, and the distal and proximal mating surfaces engage when the first and second medical connectors are securely attached in a manner that resists fluid penetration between the distal and proximal mating surfaces during engagement.

21. The closed medical connector system of claim 20, wherein the engagement structure of the first medical connector comprises a movable hook.

22. The closed medical connector system of claim 21, wherein the engagement portion of the second medical connector comprises a channel.

23. The closed medical connector system of claim 22, wherein the release structure comprises a tab configured to release the hook from the channel.

24. The closed medical connector system of claim 20, wherein the first medical connector comprises a spring to bias the valve member toward the closed position.

25. The closed medical connector system of claim 20, wherein the shroud of the first medical connector comprises a continuous circular band at a distal end of the first medical connector.

26. The closed medical connector system of claim 20, wherein the distal end of the male portion of the first medical connector is recessed proximally from a distal end of the shroud of the first medical connector.

27. The closed medical connector system of claim 26, wherein a proximal end of the seal element of the second medical connector is generally flush with a proximal end of the housing of the second medical connector in the closed configuration.

28. The closed medical connector system of claim 20, wherein the first region of the first medical connector in an initial stage of use does not rotate with respect to the second region of the first medical connector.

29. The closed medical connector system of claim 28, wherein the first medical connector transitions from the initial stage of use to the stage of use in which the first region and the second region rotate with respect to each other by breaking a tab.