Sterile connectors

• US 4,187,846 A
• Filed: 06/22/1978
• Issued: 02/12/1980
• Est. Priority Date: 06/22/1978
• Status: Expired due to Term

• Current Assignee: Cobe Cardiovascular Incorporated (LivaNova Plc)
• Original Assignee: Union Carbide Corporation (Dow, Inc.)
• Inventors: Lolachi, Houshang, Carminucci, Robert N.
• Primary Examiner(s): Callaghan, Thomas F.
• Application Number:
  US05/918,025
• Time in Patent Office: 600 Days
• Field of Search: 285/352, 285/423, 285/DIG. 2, 285/260, 285/332, 285/3, 285/4, 128/214 R, 128/214.2
• US Class Current: 604/411
• CPC Class Codes: A61M 2039/1027 Quick-acting type connectors
• CPC Class Codes: A61M 39/14 for connecting tubes having sealed ends needle sets A61M5/162; having valves closing automatically on disconnection of line A61M39/26
• CPC Class Codes: A61M 39/18 Methods or apparatus for making the connection under sterile conditions, i.e. sterile docking
• CPC Class Codes: Y10S 604/905 Aseptic connectors or couplings, e.g. frangible, piercable

Abstract

The interior sections of companion sterile connector members are isolated from the atmosphere by shield plates that are movable to uncover aligned conduits in said members through which luer fitting sections are engaged. Compressible seals positioned intermediate said shield plates and said connector members expand and contact one another as the shield plates are moved, thus forming a seal-line that advances behind the trailing edge of the shield plates as the plates are moved to uncover said conduits. The seals thus preserve the sterility of the connector prior to engagement of the luer fittings and provide added assurance against contamination thereafter without contact with the fluid passing through the luer fittings within the connector. In various embodiments, the shield plates are conveniently slid or rotated from the closed to the open position. Sterility protection is further assured by utilizing seals containing cavities forming thin membrane sections penetrable by the luer fitting and positioned in alignment with said connector member conduits.

Claims

1. A sterile connector having enhanced sterility protection and simplified operating capability comprising:

(a) a male connector member having a conduit extending therethrough, said conduit adapted to position a male luer fitting section therein;

(b) a female connector member having a conduit extending therethrough, said conduit comprising a companion female luer fitting section;

(c) means to secure said male connector member to said female connector member in matingly engaged position with the conduits in said members in alignment so as to permit communication therebetween;

(d) shield plates positionable so as to cover and isolate the conduits in said male and female connector members from the atmosphere, said shields being positioned intermediate the male and female connector members when said members are in said matingly engaged position, with one shield plate being affixed to the male connector member and the other shield plate being affixed to the female connector member, said shield plates being movable so as to uncover the respective conduits in said male and female connector members;

(e) a male luer fitting section positioned in the conduit of the male connector member, said section being adapted to isolate the end of the male connector member conduit opposite that covered by said male member shield plate from the atmosphere, said male luer fitting section being movable so as to engage and lock with female luer fitting section when said shield plates are positioned so as to uncover said conduits in the male and female connector members; and

(f) compressible seals positioned intermediate said male and female connector members and their respective shield plates, said seals being adapted to maintain isolation of said conduits from the atmosphere as said shield plates are moved so as to uncover said conduits, said seals expanding and contacting one another behind the trailing edge of said shield plates, thus forming a seal-line that advances as the shield plates are moved and preventing the sterile conduits within said male and female connected members from being exposed to the atmosphere,

whereby said luer fittings may be readily and effectively engaged and locked in a sterile environment preserved by the seal-line of said compressible seals during the convenient moving of said shield plates to expose the conduit openings through which said luer fittings are engaged, said seals providing an added assurance against contamination of fluid passing through the engaged luer fitting within the connector without exposure of said seals to contact by said fluid passing through the connector.

2. The sterile connector of claim 1 in which said shield plates are slidable plates capable of being slid out to expose said conduits at the inner ends of said connector members.

3. The sterile connector of claim 2 and including a frame on each connector member, said slidable plates being seated in said frame when in the closed position and being slidable upward to the open position with said compressible seals being released so as to form said seal-line as the plates are slid upward, thus preventing the exposure of the sterile conduit area within the connector members to outside air.

4. The sterile connector of claim 1 in which said compressible seals comprise rectangular flex seals having a cut therein facilitating the penetration of the male luer section therethrough for engagement with the companion female luer section on the other side of said connector.

5. The sterile connector of claim 3 in which said compressible seals comprise rectangular flex seals having a cut therein facilitating the penetration of the male luer section therethrough for engagement with the female luer section on the other side of said connector.

6. The sterile connector of claim 1 in which said compressible seals comprise flex seals of circular shape.

7. The sterile connector of claim 1 in which said compressible seals comprise flex seals having a doughnut configuration.

8. The sterile connector of claim 1 in which said compressible seals comprise flex seals having an X-form cross-section, thereby forming lip seals upon contact.

9. The sterile connector of claim 1 in which said male and female connector members are of rectangular configuration.

10. The sterile connector of claim 1 in which said male and female connector members are of rectangular configuration.

11. The sterile connector of claim 1 in which said male and female connector members are of circular configuration and said compressible seals comprise flex seals of circular shape.

12. The sterile connector of claim 11 in which said shield plates comprise rotatable plates capable of rotation between a closed position in which said plates cover the conduits in said connector members and an open position in which said plates expose said conduits for engagement of said luer fittings.

13. The sterile connector of claim 12 in which said conduits are eccentrically positioned, said circular flex seals having openings therein in alignment with said conduits.

14. The sterile connector of claim 12 in which said flex seals have cavities therein in alignment with said conduits, said cavities forming thin membrane sections in said seals, said membrane sections being penetrable by said male luer fitting section and being recessed from the sealing surface of said seals, thereby avoiding contact with the edge of the shield and the sealing surface wiping that occurs as the shield plates are moved to uncover said conduits.

15. The sterile connector of claim 14 in which said membrane sections have cuts therein facilitating said penetration of the male luer fitting section.

16. The sterile connector of claim 14 in which said cavities are eccentrically positioned, facilitating rotation of said shield plates between said closed and open positions.

17. The sterile connector of claim 1 and including means to position said male and female connector members in a non-matingly engaged position with the outer surfaces of said compressible seals essentially in the same plane and means for causing said shield plates to slide away from said connector members as one connector is slid with respect to the other to said matingly engaged position.

18. The sterile connector of claim 17 in which said male and female connector members are of rectangular configuration.

19. The sterile connector of claim 18 in which said compressible seals comprise flex seals of circular shape.

20. The sterile connector of claim 18 in which said compressible seals comprise flex seals having cavities therein in alignment with said conduits, said cavities forming thin membrane sections in said seals, said membrane sections being penetrable by said male luer fitting section and being recessed from the sealing surface of said seals, thereby avoiding contact with the edges of the shield plates and the sealing surface wiping that occurs as said shield plates are moved to uncover said conduits.

21. The sterile connector of claim 20 in which said membrane sections have cuts therein facilitating said penetration of the male luer fitting section.

22. The sterile connector of claim 18 in which said compressible seals comprise flex seals having a doughnut configuration.

23. The sterile connector of claim 1 in which said compressible seals comprise flex rings having cavities therein in alignment with said conduits, said cavities forming thin membrane sections in said seals, said membrane sections being penetrable by said male luer fitting section and being recessed from the sealing surface of said seals, thereby avoiding contact with the edges of the shield plates and the sealing surface wiping that occurs as said shield plates are moved to uncover said conduits.

24. The sterile connector of claim 10 on which said compressible seals comprise flex seals having cavities therein in alignment with said conduits, said cavities forming thin membrane sections in said seals, said membrane sections being penetrable by said male luer fitting section and being recessed from the sealing surface of said seals, thereby avoiding contact with the edges of the shield plates and the sealing surface wiping that occurs as said shield plates are moved to uncover said conduits.