Needleless connector

• US 6,344,033 B1
• Filed: 08/09/1999
• Issued: 02/05/2002
• Est. Priority Date: 05/20/1997
• Status: Expired

• Current Assignee: Baxter International Inc.
• Original Assignee: Baxter International Inc.
• Inventors: Ding, Samuel, Finley, Michael J., Summer, Camille, Daniels, Lewis E., Jepson, Steven C., Dudar, Thomas E., Bindokas, Algirdas J., White, Jason J., Montanez, Rodrigo A.
• Primary Examiner(s): KENNEDY, SHARON E
• Application Number:
  US09/370,864
• Time in Patent Office: 911 Days
• Field of Search: 604/246, 604/167, 604/201, 604/203, 604/236, 604/237, 604/244-256, 604/523, 604/533, 604/534, 604/535, 604/538, 604/539, 128/912
• US Class Current: 604/256
• CPC Class Codes: A61M 2005/1404 Keep vein-open rate [KVO], i.e. low flow rate
• CPC Class Codes: A61M 2039/0036 characterised by a septum having particular features, e.g. having venting channels or being made from antimicrobial or self-lubricating elastomer
• CPC Class Codes: A61M 2039/263 where the fluid space within the valve is decreasing upon disconnection
• CPC Class Codes: A61M 39/045 pre-slit to be pierced by blunt instrument
• CPC Class Codes: Y10S 128/912 Connections and closures for tubes delivering fluids to or from the body

Abstract

A needless connector is provided which utilizes a resealable preslit septum valve. The valve is resiliently restrained relative to a housing with the valve and housing configured to accept a standard male luer lock having a luer tip which penetrates the valve through the opening to extend within the housing and a luer locking flange of the luer lock extending about the housing. The valve includes a disk shaped upper portion covering the opening, a lower portion spaced from the housing and extending downward from the disk shaped portion into a passageway defined by the housing, and an annular skirt to attach the septum to the housing. The connector exhibits satisfactory leak pressure after multiple connections and disconnects to the luer lock fitting and long periods of indwell of the luer tip.

Claims

1. A connector device for establishing a sealed connection with a male luer assembly configured to conform to ISO standards, said assembly including a male luer tip, said male luer tip encircled by an annular locking flange, said male leur tip and said flange defining a generally cylindrical space between said flange and said tip, said connector device comprising:

a housing forming an upper end opening and a central first passageway sized to receive the male luer tip, said housing having an upper end portion configured to fit within the space defined by the male luer assembly when the male luer tip is inserted downward into said opening, said first central passageway extending from said opening in a downward direction within said housing, said housing including a first upper edge portion having an outside surface of generally constant first diameter, and a second lower portion spaced from said upper edge portion and having an outside surface of a generally constant second diameter, said second diameter being larger than said first diameter, said housing including a third intermediate portion extending from said distal edge portion to said second portion, said third portion having an outside surface with a changing diameter;

a resealable valve resiliently restrained relative to said housing, said valve including a first portion configured to seal said opening prior to insertion of said tip and having an upper surface radially extending across said opening, said upper surface being disposed and shaped to be easily wipeable, a second extension portion integral with said first portion and extending generally vertically downward within said passageway from a lower surface of said first portion, said valve having a third extension portion attached to one of said extension portion and a lower surface of said radial portion and extending downward, a lower end portion of said extension portion attached to said housing to form a sealed second passageway within said said extension portion, said extension portion and said housing defining a generally annular space between said extension portion and said housing; and

an opening formed in said valve such that when the luer tip is inserted downward into said opening in said housing and through said septum said first portion and said second portion elastically extend about the luer tip and form a seal about said luer tip and allow fluid to be injected from said tip into said second passageway, the attachment of said lower end of portion of said extension portion to said housing being such that fluid injected into said second passageway flows through said housing without flowing into said annular space.

2. The connector device of claim 1 wherein said valve includes a septum having an annular skirt attached to said first portion, said skirt extending over and attached to an outside surface of said housing proximate said opening.

3. The connector device of claim 2 wherein said septum includes an annular channel formed by said skirt and said first portion, a distal edge portion of said housing received in said channel.

4. The connector device of claim 3 wherein said distal edge portion forms a distal landing received in said channel, at least a portion of said distal landing being attached to said septum.

5. The connector of claim 4 wherein the entire length of said landing is attached to said septum.

6. The connector device of claim 5 wherein said connector includes a bonding agent to attach said outside surface of said housing and said landing to said septum.

7. The connector device of claim 1 wherein said second portion of said resealable valve is formed with a generally rectangular cross section in the proximate direction.

8. The connector device of claim 1 wherein said valve includes a septum having an annular skirt attached to said first portion, said skirt extending over and attached to an outside surface of said housing proximate said opening.

9. A connector device for establishing a sealed connection with a male luer assembly configured to conform to ISO standards, said assembly including a male luer tip and having a generally annular flange disposed generally about said male luer tip and defining a generally cylindrical space between said flange and said tip, said connector device comprising:

a housing forming an upper opening and a central first passageway sized to receive the male luer tip, said housing having an upper end portion configured to fit within the generally cylindrical space defined by the male luer assembly when the male luer tip is inserted downward into said opening, said first central passageway extending from said opening in a downward direction within said housing;

a resealable valve resiliently restrained relative to said housing, said valve including,

a first portion configured to seal said opening prior to insertion of said tip and having an upper surface radially extending across said opening, said upper surface being disposed and shaped to be easily wipeable,

a second portion integral with said first portion and extending generally vertically downward within said passageway from a lower surface of said first portion, and

a third extension portion attached to said lower surface of said first portion and extending downward, a lower end portion of said third portion attached to said housing to form a sealed second passageway within said extension portion, said second portion extending within said second sealed passageway portion, said third extension portion and said housing defining a generally annular space between said extension portion and said housing; and

an opening formed in said valve such that when the luer tip is inserted downward into said opening in said housing and through said septum said first portion and said second portion elastically extend about the luer tip and form a seal about said luer tip and allow fluid to be injected from said tip into said second passageway, the attachment of said lower end of portion of said extension portion to said housing being such that fluid injected into said second passageway flows through said housing without flowing into said annular space.

10. The connector device of claim 9 wherein said septum includes an annular channel formed by said skirt and said first portion, a distal edge portion of said housing received in said channel.

11. The connector device of claim 10 wherein said distal edge portion forms a distal landing received in said channel, at least a portion of said distal landing being attached to said septum.

12. The connector of claim 11 wherein the entire length of said landing is attached to said septum.

13. The connector device of claim 12 wherein said connector includes a bonding agent to attach said outside surface of said housing and said landing to said septum.

14. The connector device of claim 13 wherein said second portion of said resealable valve is formed with a generally rectangular cross section in the proximate direction.