Solution container for continuous ambulatory peritoneal dialysis

• US 4,346,703 A
• Filed: 09/15/1980
• Issued: 08/31/1982
• Est. Priority Date: 01/23/1979
• Status: Expired due to Term

• Current Assignee: Baxter Travenol Laboratories Incorporated
• Original Assignee: Baxter Travenol Laboratories Incorporated
• Inventors: Dennehey, T. Michael, Greff, Richard J., Wolf, Ludwig Jr.
• Primary Examiner(s): Howell, Kyle L.
• Assistant Examiner(s): Wallen, T. J.
• Application Number:
  US06/187,008
• Time in Patent Office: 715 Days
• Field of Search: 128/213 R, 128/213 A, 128/214 R, 128/214.2, 128/214.4, 128/247, 128/272, 128/348, 137/599.1, 137/360, 285/174, 285/242, 285/423, 285/12
• US Class Current: 604/406
• CPC Class Codes: A61J 1/14 Details; Accessories therefor A61J7/00 takes precedence; openers B65D, B67B7/00
• CPC Class Codes: A61M 1/28 Peritoneal dialysis ; Other peritoneal treatment, e.g. oxygenation
• CPC Class Codes: A61M 1/285 Catheters therefor
• CPC Class Codes: A61M 2039/1033 Swivel nut connectors, e.g. threaded connectors, bayonet-connectors
• 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 39/221 Frangible or pierceable closures within tubing A61M39/14 takes precedence; frangible closures for containers A61J1/14
• CPC Class Codes: A61M 5/14 Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
• CPC Class Codes: Y10S 604/905 Aseptic connectors or couplings, e.g. frangible, piercable

Abstract

Equipment for continuous ambulatory peritoneal dialysis in which a solution container is coupled via flexible tubing to a patient'"'"'s tube that communicates with the patient'"'"'s peritoneal cavity by means of a catheter, usually a surgically implanted catheter. The equipment includes a flexible, foldable plastic dialysis solution container having a transfer port. A flexible tube having a luer connector at its distal end extends from the transfer port, for connecting to a luer connector carried by the patient'"'"'s tube. The flexible tube carries a frangible member which normally blocks fluid flow but permits fluid flow after the frangible member is broken. A particulate filter and a manually-operable clamp are in series with the flexible tube.

Peritoneal dialysis is accomplished by connecting the luer connector from a fresh dialysis solution bag to the patient'"'"'s tube luer connector, breaking the frangible member, and opening the clamp on the flexible tubing. After the dialysis solution is introduced into the patient'"'"'s peritoneal cavity and remains there for a predetermined time, the solution is drained back into the flexible bag, the luer connectors are disconnected and the foregoing steps are repeated. If desired, once the dialysis solution has been introduced into the patient'"'"'s peritoneal cavity, the luer connections may be disconnected and the patient'"'"'s tube luer connector may be capped.

Claims

1. Equipment for continuous ambulatory peritoneal dialysis in which a solution container is coupled via flexible tubing to a patient'"'"'s tube that communicates with the patient'"'"'s peritoneal cavity, which comprises:

a flexible, foldable plastic dialysis solution container having a transfer port extending therefrom;

a flexible tube extending from said transfer port and having a luer connector at its distal end for connecting to a luer connector carried by the patient'"'"'s tube, said luer connector at said distal end and said patient'"'"'s tube luer connector comprising a cooperating male luer connector and female luer connector, said male luer connector having a central tubular portion defining an axial bore with at least a portion of said central tubular portion being enclosed by an outer sheath having a generally circular cross-sectional configuration, said outer sheath having a threaded internal wall, and a female luer connector comprising a main tubular member, said male luer central tubular portion and said female luer main tubular member being cooperative to provide a first liquid seal, said female luer connector having an outwardly extending flange adjacent its distal end, said flange being dimensioned to threadedly cooperate with the threads on the internal wall of said male luer connector'"'"'s outer sheath, and a sealing means for providing a second liquid seal with the internal wall of said outer sheath when the male and female connectors are connected, to aid in maintaining a water-tight bacteria barrier at the luer connection.

2. Equipment as described in claim 1, wherein said sealing means comprises an elastomeric member carried by said female luer connector;

said elastomeric member being dimensioned and operable to provide said second liquid seal with said outer sheath.

3. Equipment as described in claim 1, wherein said sealing means comprises said female luer connector having a rigid outer wall portion that is dimensioned to provide said second liquid seal with the internal wall of said outer sheath;

said outer sheath being formed of a resilient material.

4. Equipment as described in claim 1, wherein said flange comprises a single annular member adjacent said distal end.

5. Equipment as described in claim 1, wherein said flange comprises external threads.

6. Equipment as described in claim 1, further comprising a frangible member in said flexible tube, said frangible member normally blocking fluid flow in said flexible tube but permitting fluid flow after said frangible member is broken.

7. Equipment as described in claim 6, further comprising a particulate filter in series with said flexible tube;

and a manually-operable clamp in series with said flexible tube.

8. The equipment for continuous ambulatory peritoneal dialysis of claim 1 in which said female luer connector is made of titanium and said male luer connector is made of a resilient material.

9. A luer lock connection device which comprises:

a cooperating male luer connector and a female luer connector;

said male luer connector having a central tubular portion defining an axial bore with at least a portion of said central tubular portion being enclosed by an outer sheath having a generally circular cross-sectional configuration;

said outer sheath having a threaded internal wall;

a female luer connector comprising a main tubular member, said male luer central tubular portion and said female luer main tubular member being cooperative to provide a first liquid seal, said female luer connector having an outwardly extending flange adjacent its distal end;

said flange being dimensioned to threadedly cooperate with the threads on the internal wall of said male luer connector'"'"'s outer sheath; and

a sealing means for providing a second liquid seal with the internal wall of said outer sheath when the male and female connectors are connected, to aid in maintaining a water-tight bacteria barrier at the luer connection.

10. A luer lock connection device as described in claim 9, wherein said sealing means comprises an elastomeric member carried by said female luer connector;

said elastomeric member being dimensioned and operable to provide said second liquid seal with said outer sheath.

11. A luer lock connection device as described in claim 9, said female luer connector having an annular manually-graspable ring extending radially outwardly therefrom, said elastomeric member comprising a ring-like member surrounding said central tubular portion adjacent said manually graspable ring toward said distal end of said female luer connector.

12. A luer lock connection device as described in claim 9, wherein said sealing means comprises said female luer connector having a rigid outer wall portion that is dimensioned to provide said second liquid seal with the internal wall of said outer sheath;

said outer sheath being formed of a resilient material.

13. A luer lock connection device as described in claim 12, said outer wall portion having a rearwardly extending outward taper whereby a pressure engagement of the internal wall of the outer sheath and said outer wall portion will increase as the male and female connectors are threaded together.

14. The luer lock connection device as described in claim 13, further comprising a knurled, manually-graspable portion contiguous with said outer wall portion;

and tube coupling means extending rearwardly from said knurled portion.

15. A luer lock connection device as described in claim 9, wherein said flange comprises a single annular member adjacent said distal end.

16. A luer lock connection device as described in claim 9, wherein said flange comprises external threads.

17. The luer lock connection device of claim 9 in which said female luer connector is made of titanium and the male luer connector is made of a resilient material.

18. Equipment for continuous ambulatory peritoneal dialysis in which a solution container is coupled via flexible tubing to a patient'"'"'s tube that communicates with the patient'"'"'s peritoneal cavity, which comprises:

a flexible, foldable plastic dialysis solution container having a transfer port extending therefrom;

a first luer connector carried by said transfer port;

a flexible tube having a second luer connector at one end thereof for cooperative engagement with said first luer connector, said flexible tube having a luer connector at its other end for connecting to a luer connector carried by the patient'"'"'s tube, said luer connector at said other end and said patient'"'"'s tube luer connector comprising a cooperating male luer connector and female luer lock connector, said male luer connector having a central tubular portion defining an axial bore with at least a portion of said central tubular portion being enclosed by an outer sheath having a generally circular cross-sectional configuration, said outer sheath having a threaded internal wall, and a female luer connector comprising a main tubular member, said male luer central tubular portion and said female luer main tubular member being cooperative to provide a first liquid seal, said female luer connector having external threads adjacent its distal end, said external threads being dimensioned to threadedly cooperate with the threads on the internal wall of said male luer connector'"'"'s outer sheath, and sealing means for providing a second liquid seal with the internal wall of said outer sheath when the male and female connectors are connected, to aid in maintaining a water-tight bacteria barrier at the luer lock connection, said sealing means comprising said female luer connector being formed of metal and having a rigid outer wall portion that is dimensioned to provide said second liquid seal with the internal wall of said outer sheath, said outer sheath being formed of a resilient material.

19. Equipment as described in claim 18, in which said first and second luer connectors comprise a cooperating male luer connector and female luer connector, said male luer connector having a central tubular portion defining an axial bore with at least a portion of said central tubular portion being enclosed by an outer sheath having a generally circular cross-sectional configuration, said outer sheath having a threaded internal wall, and a female luer connector comprising a main tubular member, said male luer central tubular portion and said female luer main tubular member being cooperative to provide a first liquid seal, said female luer connector having external threads adjacent its distal end, said external threads being dimensioned to threadedly cooperate with the threads on the internal wall of said male luer connector'"'"'s outer sheath, and sealing means for providing a second liquid seal with the internal wall of said outer sheath when the male and female connectors are connected, to aid in maintaining a water-tight bacteria barrier at the luer lock connection.

20. A tubing set for use with equipment for continuous ambulatory peritoneal dialysis in which a solution container is coupled via the tubing set to a patient'"'"'s tube that communicates with the patient'"'"'s peritoneal cavity, and with the solution container having a transfer port carrying a luer connector and the patient'"'"'s tube carrying a luer connector, said tubing set comprising:

a flexible tube having a first luer connector at one end for connecting to the transfer port'"'"'s luer connector and having a second luer connector carried at the other end for connecting to the patient'"'"'s tube luer connector;

the luer connections at the transfer port and the patient'"'"'s tube each comprising a cooperating male luer connector and a female luer connector, said male luer connector having a central tubular portion defining an axial bore with at least a portion of said central tubular portion being enclosed by an outer sheath having a generally circular cross-sectional configuration, said outer sheath having a threaded internal wall, and said female luer connector comprising a main tubular member having an outwardly extending flange adjacent its distal end, said flange being dimensioned to threadedly cooperate with the threads on the internal wall of a male luer connector'"'"'s outer sheath, and a sealing means for providing a pressure seal-like engagement with the internal wall of an outer sheath of a male connector when the male and female connectors of this type are connected, to aid in maintaining a water-tight bacteria barrier at the luer lock connection.

21. A tubing set for use with equipment for continuous ambulatory peritoneal dialysis in which a solution container is coupled via the tubing set to a patient'"'"'s tube that communicates with the patient'"'"'s peritoneal cavity, and with the solution container having a transfer port carrying a luer connector and the patient'"'"'s tube carrying a luer connector, said tubing set comprising:

a flexible tube having a first luer connector at one end for connecting to the transfer port'"'"'s luer connector and having a second luer connector carried at the other end for connecting to the patient'"'"'s tube luer connector;

said first luer connector being one of a male luer connector and a female luer connector, and said second luer connector being one of a male luer connector and a female luer connector, said male luer connector having a central tubular portion defining an axial bore with at least a portion of said central tubular portion being enclosed by an outer sheath having a generally circular cross-sectional configuration, said outer sheath having a threaded internal wall;

said female luer connector comprising a main tubular member having an outwardly extending flange adjacent its distal end, said flange being dimensioned to threadedly cooperate with the threads on the internal wall of a male luer connector'"'"'s outer sheath; and

a sealing means for providing a pressure seal-like engagement with the internal wall of the outer sheath when the male connector is connected to a female connector and when the female connector is connected to a male connector, to aid in maintaining a water-tight bacteria barrier at the luer lock connection.

22. A tubing set for use with equipment for continuous ambulatory peritoneal dialysis in which a solution container is coupled via the tubing set to a patient'"'"'s tube that communicates with the patient'"'"'s peritoneal cavity, and with the solution container having a transfer port carrying a female luer connector and the patient'"'"'s tube carrying a female luer connector, said tubing set comprising:

a flexible tube having a first male luer connector at one end for connecting to the transfer port'"'"'s female luer connector and having a second male luer connector carried at the other end for connecting to the patient'"'"'s tube female luer connector;

said male luer connectors each having a central tubular portion defining an axial bore with at least a portion of said central tubular portion being enclosed by an outer sheath having a generally circular cross-sectional configuration, said outer sheath having a threaded internal wall adapted for engagement with the external surface of the respective female luer connector, said outer sheath also defining a free annular end positioned beyond said central tubular portion to circumferentially enclose the entire length of said central tubular portion within said outer sheath, a portion of the internal wall of said outer sheath adjacent said free annular end defining a smooth, cylindrical sealing surface free of threads to provide a seal when connected with a female luer connector.

23. Equipment for continuous ambulatory peritoneal dialysis in which a solution container is coupled via flexible tubing to a patient'"'"'s tube that communicates with the patient'"'"'s peritoneal cavity, which comprises:

a flexible, foldable plastic dialysis solution container having a transfer port extending therefrom;

a flexible tube extending from said transfer port and having a luer connector at its distal end for connecting to a luer connector carried by the patient'"'"'s tube, said luer connector comprising a cooperating male luer connector and female luer connector, said male luer connector having a central tubular portion defining an axial bore with at least a portion of said central tubular portion being enclosed by an outer sheath having a generally circular cross-sectional configuration, said outer sheath having first means for cooperative locking with a female luer connector; and

a female luer connector comprising a main tubular member, said male luer central tubular portion and said female luer main tubular member being cooperative to provide a first liquid seal, said female luer connector having second means for cooperative locking with said first cooperative locking means, and a sealing means for providing a second liquid seal with the internal wall of said outer sheath when the male and female connectors are connected and said first and second cooperative locking means are engaged, to aid in maintaining a water-tight bacteria barrier at the luer lock connection.

24. Equipment as described in claim 23, said first cooperative locking means comprising an internally threaded wall and said second cooperative locking means comprising an outwardly extending flange adjacent the distal end of the female luer connector.

25. Equipment as described in claim 24, wherein said flange comprises a single annular member adjacent said distal end.

26. Equipment as described in claim 24, wherein said flange comprises external threads.

27. Equipment as described in claim 23, wherein said sealing means comprises an elastomeric member carried by said female luer connector;

said elastomeric member being dimensioned and operable to provide said second liquid seal with said outer sheath.

28. Equipment as described in claim 23, wherein said sealing means comprises said female luer connector having a rigid outer wall portion that is dimensioned to provide said second liquid seal with the internal wall of said outer sheath;

said outer sheath being formed of a resilient material.

29. Equipment as described in claim 23, further comprising a frangible member in said flexible tube, said frangible member normally blocking fluid flow in said flexible tube but permitting fluid flow after said frangible member is broken.

30. The equipment for continuous ambulatory peritoneal dialysis of claim 23 in which the female luer connector is made of titanium and the male luer connector is made of a resilient material.

31. A luer lock connection device which comprises:

a cooperating male luer connector and a female luer connector;

said male luer connector having a central tubular portion defining an axial bore with at least a portion of said central tubular portion being enclosed by an outer sheath having a generally circular cross-sectional configuration;

said outer sheath having first means for cooperative locking with a female luer connector;

a female luer connector comprising a main tubular member, said male luer central tubular portion and said female luer main tubular member being cooperative to provide a first liquid seal, said female luer connector having second means for cooperative locking with said first cooperative locking means; and

a sealing means for providing a second liquid seal with the internal wall of said outer sheath when the male and female connectors are connected and said first and second cooperative locking means are engaged, to aid in maintaining a water-tight bacteria barrier at the luer connection.

32. A luer lock connection device as described in claim 31, wherein said sealing means comprises an elastomeric member carried by said female luer connector;

said elastomeric member being dimensioned and operable to provide said second liquid seal with said outer sheath.

33. A luer lock connection device as described in claim 31, wherein said sealing means comprises said female luer connector having a rigid outer wall portion that is dimensioned to provide said second liquid seal with the internal wall of said outer sheath;

said outer sheath being formed of a resilient material.

34. A tubing set for use with equipment for continuous ambulatory peritoneal dialysis in which a solution container is coupled via the tubing set to a patient'"'"'s tube that communicates with the patient'"'"'s peritoneal cavity, and with the solution container having a transfer port carrying a luer connector and the patient'"'"'s tube carrying a luer connector, said tubing set comprising:

a flexible tube having a first luer connector at one end for connecting to the transfer port'"'"'s luer connector and having a second luer connector carried at the other end for connecting to the patient'"'"'s tube luer connector;

the luer connections at the transfer port and the patient'"'"'s tube each comprising a cooperating male luer connector and a female luer connector, said male luer connector having a central tubular portion defining an axial bore with at least a portion of said central tubular portion being enclosed by an outer sheath having a generally circular cross-sectional configuration, said outer sheath having first means for cooperative locking with a female luer connector comprising a main tubular member, said male luer central tubular portion and said female luer main tubular member being cooperative to provide a first liquid seal, said female luer connector having second means for cooperative locking with said first cooperative locking means, and a sealing means for providing a pressure seal-like engagement with the internal wall of an outer sheath of a male connector when the male and female connectors of this type are connected and said first and second cooperative locking means are engaged, to aid in maintaining a water-tight bacteria barrier at the luer lock connection.

35. Equipment for continuous ambulatory peritoneal dialysis in which a flexible plastic solution container having a transfer port is coupled by flexible tubing to a patient'"'"'s tube that communicates with the patient'"'"'s peritoneal cavity, the patient'"'"'s tube having a female luer connector formed of metal and comprising a main tubular member with cooperative locking means, the equipment comprising:

a flexible tube for extension from the transfer port and having a male luer connector at its distal end for connecting to and cooperating with the patient'"'"'s female luer connector, said male luer connector having a central tubular portion defining an axial bore with at least a portion of said central tubular portion being enclosed by an outer sheath having a generally circular cross-sectional configuration, said outer sheath having means for locking with the cooperative locking means of the female luer connector, said male luer central tubular portion being cooperative with the female luer main tubular member to provide a first liquid seal;

said outer sheath being formed of a resilient material to cooperate with the metal female luer connector to provide a second liquid seal when said male luer connector is connected to the female luer connector and the cooperative locking means are engaged, to aid in maintaining a water-tight bacteria barrier at the luer lock connection.

36. Equipment as described in claim 35, said locking means of said outer sheath comprising an internally threaded wall.

37. A tubing set for use with equipment for continuous ambulatory peritoneal dialysis in which a solution container is coupled via the tubing set to a patient'"'"'s tube that communicates with the patient'"'"'s peritoneal cavity, said tubing set defining flexible tubing means carrying at one end means for connection with the contents of said solution container, and carrying at its other end a male luer connector for sealing connection with a female luer connector of the patient'"'"'s tube;

said male luer connector having a central tubular luer portion defining an axial bore with at least a portion of said central tubular luer portion being enclosed by an outer sheath having a generally circular cross-sectional configuration and defining a free annular end, a portion of said outer sheath defining a threaded internal wall portion adapted for engagement with said female luer connector, said threaded internal wall portion being spaced from the free annular end of said sheath by a portion of the inner surface of said sheath which defines an annular sealing area free of threads for cooperation with said female luer connector to form an annular seal area.

38. The tubing set of claim 37 in which the male luer connector is made of a resilient material.

39. The tubing set of claim 37 in which said free annular end is positioned beyond said central tubular luer portion to circumferentially enclose the entire length of said central tubular luer portion within said outer sheath.

40. The tubing set of claim 39 which is attached to a peritoneal dialysis solution container.