Medical connector

• US 9,186,494 B2
• Filed: 05/02/2014
• Issued: 11/17/2015
• Est. Priority Date: 11/05/2004
• Status: Active Grant

• Current Assignee: ICU Medical Incorporated
• Original Assignee: ICU Medical Incorporated
• Inventors: Fangrow, Thomas F.
• Primary Examiner(s): Gray, Phillip
• Application Number:
  US14/268,489
• Publication Number:
  US 20150011979A1
• Time in Patent Office: 564 Days
• Field of Search: 604533-284, 604246-256
• US Class Current: 1/1
• CPC Class Codes: A61M 2039/263 where the fluid space within the valve is decreasing upon disconnection
• CPC Class Codes: A61M 2039/266 where the valve comprises venting channels, e.g. to insure better connection, to help decreasing the fluid space upon disconnection, or to help the fluid space to remain the same during disconnection
• CPC Class Codes: A61M 2205/02 characterised by a particular materials
• CPC Class Codes: A61M 2205/586 Ergonomic details therefor, e.g. specific ergonomics for left or right-handed users
• CPC Class Codes: A61M 39/045 pre-slit to be pierced by blunt instrument
• CPC Class Codes: A61M 39/10 Tube connectors; Tube couplings A61M39/02 takes precedence; connecting needles to syringes or hubs A61M5/34; connecting catheter tubes to hubs A61M25/0014
• 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 39/26 Valves closing automatically on disconnecting the line and opening on reconnection thereof check valves A61M39/24
• CPC Class Codes: Y10T 29/49826 Assembling or joining

Abstract

A soft grip medical connector comprises a housing with an upstream end, a downstream end and a lumen extending through a central portion thereof. A flexible member comprises a valve portion integrally formed with a sleeve portion. The valve portion is positioned within a section of the housing and is configured to control a flow of fluid through the housing lumen. The sleeve is inverted to envelope at least a portion of the outer surface of the housing. In some embodiments the gripping portion is integrally formed with the valve portion. In some embodiments, the connector is also generally configured to create a positive pressure in a catheter lumen upon removal of a syringe or other medical device from the upstream end of the connector. Methods of making a medical fluid connector generally comprise forming a valve member with a sleeve extending there from, and assembling the valve, sleeve and housing.

Claims

1. A medical connector for selectively permitting fluid to flow between a first medical device and a second medical device, the medical connector comprising:

a housing comprising an upstream end adapted to receive the second medical device, a downstream end with an interface configured to receive the first medical device, an outer surface, a base member with an annular surface, an upper housing cavity extending from the upstream end of the housing to the annular surface of the base member, and an interior cannula extending from the annular surface toward the upstream end of the housing; and

a valve member at least partially positioned within the housing, the valve member configured to control a flow of fluid through the housing, the valve member comprising a seal body made of a flexible material, the seal body having a downstream end, an upstream end configured to receive at least a portion of the second medical device, and a normally closed passage in fluid communication with the downstream end of the seal body and the upstream end of the seal body, the seal body comprising a first sidewall and a second sidewall, the second sidewall opposing the first sidewall, the first and second sidewalls diverging in a downstream direction such that the passage has a non-zero volume when in an undisturbed state in which a first end of the second medical device is not in contact with the upstream end of the seal body;

wherein the valve member comprises a lead lumen at the downstream end of the seal body configured to fit over an outside surface of the interior cannula such that the downstream end of the seal body is separated from the annular surface of the base member by a first distance when the valve member is in a closed state, and wherein, upon insertion of the portion of the second medical device into the passage, the downstream end of the seal body slides in the downstream direction along the outer surface of the interior cannula such that the downstream end of the seal body is separated from the annular surface of the base member by a second distance, the first distance being greater than the second distance;

wherein the valve member comprises a transverse flange having a slit opening therethrough in fluid communication with the passage; and

wherein the valve member comprises shoulders configured to engage corresponding edges of the housing, wherein the distance between the upstream end of the housing and the edges is greater than the distance between the transverse flange and the shoulders, such that the valve member is under a preload when the shoulders engage the edges causing the transverse flange to bear on the upstream end of the housing.

2. The connector of claim 1, wherein the housing comprises an upstream housing portion containing the valve member and a downstream housing portion configured to be mateably coupled to the upstream housing portion.

3. The connector of claim 2, wherein the upstream housing portion comprises one or more alignment features, and wherein the downstream housing portion comprises one or more alignment features configured to engage the one or more alignment features of the upstream housing portion to align the upstream housing portion with the downstream housing portion.

4. The connector of claim 1, wherein the housing comprises protrusions on an upper portion thereof, the protrusions configured to engage internal threads of a Luer connector for securing the second medical device to an upstream end of the connector.

5. The connector of claim 1, wherein the housing is constructed of a polycarbonate material.

6. The connector of claim 1, wherein the housing is constructed of a glass-reinforced thermoplastic polyester resin.

7. The connector of claim 1, wherein the seal body is made of silicone rubber.

8. The connector of claim 1, wherein the valve member is constructed of silicone rubber.

9. The connector of claim 1, wherein the housing comprises an hourglass-shaped profile.

10. The connector of claim 1, wherein the connector comprises an hourglass-shaped profile.

11. The connector of claim 1, wherein the valve member comprises features arranged to interact with features of the housing in order to limit movement of the valve member relative to the housing.

12. The connector of claim 1, wherein the housing further comprises at least one vent configured to ventilate the upper housing cavity.

13. The connector of claim 1, wherein a lower surface of the housing comprises at least one vent configured to allow air flow into and out of a Luer lock cavity within the housing when a lower portion of the connector is joined to the first medical device.

14. The connector of claim 1, wherein the valve member is configured to force a volume of fluid downwards through the interior cannula upon removal of the second medical device from the upstream end of the housing.

15. The connector of claim 14, wherein the passage is adapted to have a relatively small interior volume when in an undisturbed state and a larger interior volume upon the introduction of the portion of the second medical device into the passage, the passage adapted to retract to define a restricted flow path and a relatively small interior volume upon the withdrawal of the portion of the second medical device from the passage, at least a portion of the upstream end of the seal body adapted to initially press against the inserted portion of the second medical device as the second medical device is withdrawn, so that a fluid occupying the interior volume is forced toward the downstream end of the seal body as the passage retracts.

16. The connector of claim 15, wherein the seal body further comprises at least one rib on an outer surface of the seal body, the rib extending transversely relative to the passage and spanning longitudinally from the region near the upstream end of the seal body to the region near the downstream end of the seal body.

17. The connector of claim 1, wherein the valve member is adhered to the housing in order to limit movement of the valve member relative to the housing.

18. The connector of claim 1, wherein the valve member further defines an unobstructed linear flow path when the second medical device is inserted into the medical connector.

19. The connector of claim 1, wherein the medical connector is configured to selectively permit an unobstructed linear flow of fluid therethrough.

20. The connector of claim 1, wherein the passage is configured to selectively permit an unobstructed flow of fluid therethrough at a flow rate of at least approximately 600 cubic centimeters per minute.

21. The connector of claim 1, wherein the first and second sidewalls are configured to separate to expand the passage when a fluid is flowing through the valve member.

22. The connector of claim 1, wherein the seal body comprises a neck portion positioned in a region near the upstream end of the seal body, the passage being relatively narrow in the region of the upstream end of the seal body.

23. The connector of claim 22, wherein the transverse flange extends from the neck portion towards the housing.

24. The connector of claim 1, wherein the upstream end and the downstream end of the housing are disposed on the same axis to assist in providing a straight fluid-flow path through the medical connector.

25. The connector of claim 1, wherein the first sidewall and the second sidewall define a region of contact at an upstream end of the valve member at least when the valve member is in a closed state.

26. The connector of claim 25, wherein the region of contact between the first sidewall and the second sidewall is relatively small to facilitate opening of the medical connector.

27. The connector of claim 1, wherein the upstream end of the housing and the downstream end of the housing are disposed on the same axis to assist in providing a straight fluid flow path through the medical connector, wherein the first sidewall and the second sidewall define a region of contact at the upstream end of the seal body at least when the valve member is in a closed state, the region of contact between the first sidewall and the second sidewall being relatively small to facilitate opening of the medical connector, and wherein the passage is configured to selectively permit an unobstructed flow of fluid therethrough at a flow rate of at least approximately 600 cubic centimeters per minute.

28. The connector of claim 1, wherein at least one of the first sidewall and the second sidewall has a lateral thickness that increases in the downstream direction along the length of the seal body.

29. The connector of claim 1, wherein the transverse flange bears on the upstream end of the housing such that the valve member is preloaded towards a closed position.

30. The connector of claim 1, wherein the transverse flange has a concave configuration to bias the slit opening towards a closed position when in a closed state.