Medical connector having high flow rate characteristics

• US 7,824,393 B2
• Filed: 05/03/2006
• Issued: 11/02/2010
• 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): Sirmons; Kevin C
• Assistant Examiner(s): GRAY, PHILLIP A
• Application Number:
  US11/417,675
• Publication Number:
  US 20060264848A1
• Time in Patent Office: 1,644 Days
• Field of Search: None
• US Class Current: 604/533
• 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 can include a housing and a flexible member. The housing has a lumen extending through it from an upstream end to the downstream end. The flexible member includes a valve portion integrally formed with a sleeve portion. The valve portion is positioned within a section of the housing and can control a flow of fluid through the housing lumen. The sleeve can be inverted to envelop some or all of the outer surface of the housing. The sleeve can include a gripping portion integrally formed with the valve portion. The connector can also create a positive pressure in the lumen upon removal of a syringe or other medical device from the upstream end of the connector.

Claims

1. A medical connector for selectively permitting fluid to flow at high flow rates between a first medical device and a second medical device having a standard medical Luer tip at a first end thereof, 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 a generally annular surface, an upper housing cavity extending from the upstream end of the housing to the generally annular surface of the base member, and an interior cannula extending from the generally annular surface toward the upstream end of the housing, the interior cannula having a height defined by the distance between the generally annular surface and an upstream end of the interior cannula closest to the upstream end of the housing, the upstream end of the housing having a substantially circular, substantially rigid, and substantially continuous periphery; 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 element made of a flexible material, the seal element having a downstream end, an upstream end configured to receive at least a portion of the second medical device, and a normally substantially closed passage in fluid communication with the downstream end of the seal element and the upstream end of the seal element, the seal element comprising a first sidewall and a second sidewall, the second sidewall generally opposing the first sidewall;

wherein the medical connector is configured so that upon full insertion of a portion of the first end of the second medical device into an upstream end of the passage, the distance between a lead surface of the Luer tip at the first end of the second medical device and the upstream end of the interior cannula is approximately the same size as an inner diameter of the interior cannula;

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

wherein the valve member further comprises a transverse flange having at least one slit opening therethrough in fluid communication with the passage;

wherein at least one of the first sidewall and the second sidewall comprises at least a portion having a lateral thickness that is greater than a thickness of the transverse flange.

2. The medical connector of claim 1, wherein the housing comprises a first housing portion and a second housing portion.

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

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

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

6. The medical connector of claim 1, wherein the medical connector is configured to selectively permit a substantially unobstructed, non-turbulent flow of fluid therethrough.

7. The medical connector of claim 1, wherein the substantially circular, substantially rigid, and substantially continuous periphery of the housing extends from the upstream end toward the downstream end of the housing.

8. The medical connector of claim 1, wherein the medical connector is configured so that upon full insertion of the portion of the first end of the second medical device into the upstream end of the passage, the distance between the lead surface of the Luer tip at the first end of the second medical device and the upstream end of the interior cannula is less than the height of the interior cannula.

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

10. The medical connector of claim 9, wherein the transverse flange extends from the neck portion towards the housing.

11. The medical connector of claim 1, wherein the passage is adapted to have a relatively small interior volume when in a substantially closed state and a larger interior volume upon the introduction of the second medical device into the upstream end of the seal element, the passage adapted to retract to define a restricted flow path and the relatively small interior volume upon the withdrawal of the second medical device of the seal element, at least a portion of the upstream end of the seal element 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 element as the passage retracts.

12. The medical connector of claim 1 further comprising a gripping portion.

13. The medical connector of claim 12, wherein the gripping portion is disposed over at least a portion of the outer surface of the housing.

14. The medical connector of claim 12, wherein the gripping portion is integrally formed with the valve member.

15. The medical connector of claim 1, wherein the medical connector comprises a substantially hourglass-shaped profile.

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

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

18. The medical connector of claim 17, wherein the region of contact between the first sidewall and the second sidewall is relatively small to facilitate opening of the medical connector.

19. The medical connector of claim 1, wherein the passage has a non-zero volume when the valve member is in a substantially closed state.

20. The medical connector of claim 1, wherein the upstream end of the housing and the downstream end of the housing are disposed on substantially the same axis to assist in providing a substantially 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 element at least when the valve member is in a substantially closed state, the region of contact between the first sidewall and the second sidewall being relatively small to facilitate opening of the medical connector, wherein the passage has a non-zero volume when the valve member is in a substantially closed state, and wherein the passage is configured to selectively permit a substantially unobstructed flow of fluid therethrough at a flow rate of at least approximately 600 cubic centimeters per minute.

21. The medical 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 element.

22. The medical 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.

23. The medical connector of claim 22, wherein the valve member comprises one or more shoulders configured to engage one or more corresponding edges of the housing, wherein the distance between the upstream end of the housing and the one or more edges is greater than the relaxed distance between the transverse flange and the one or more shoulders, such that the valve member is stretched when the one or more shoulders engage the one or more edges causing the transverse flange to bear on the upstream end of the housing.

24. The medical connector of claim 22, wherein the transverse flange has a generally concave configuration to bias the slit opening towards a closed position when in a substantially closed state.