Pack for administration of sterile liquids including pharmaceutical, nutrient and energy-source liquids

• US 5,192,272 A
• Filed: 10/25/1990
• Issued: 03/09/1993
• Est. Priority Date: 10/26/1989
• Status: Expired due to Fees

• Current Assignee: Jean-Marie Faure
• Original Assignee: Jean-Marie Faure
• Inventors: Faure, Jean-Marie
• Primary Examiner(s): Hirsch, Paul J.
• Application Number:
  US07/603,323
• Time in Patent Office: 866 Days
• Field of Search: 604/150, 604/141, 604/132, 604/32, 604/133, 604/134, 604/135, 604/136, 604/153, 128/DIG. 12
• US Class Current: 604/141
• CPC Class Codes: A61J 1/10 Bag-type containers
• CPC Class Codes: A61M 2205/705 Testing of filters for leaks
• CPC Class Codes: A61M 5/148 flexible, e.g. independent bagsA61M5/155 takes precedence
• CPC Class Codes: Y10S 128/12 Pressure infusion

Abstract

A pack for slow administration to a patient of extremely accurate volumes of sterile, for example pharmaceutical, nutrient or energy-source liquid, comprises in combination at least three systems adapted to be interconnected. The first system is a flowrate regulator. The second system is, for each sterile liquid administered, a sterile bag with a mobile, flexible and continuous wall which delimits an internal cavity in which is at least one opening enabling it to communicate selectively with the exterior. The third system is a solid or fluid piston operating on the interior or exterior side of the wall of said bag to vary its volume, and, in the case of a fluid piston, at least one alarm means indicating any leak in the wall or one of the walls of the bag, adapted by its existence or its properties to convert non-perceptible leakage into a perceptible phenomenon.

Claims

1. A container for administering a flowable substance to a patient comprising wall means defining a first chamber adapted to be at least partially filled with the flowable substance, said first chamber having means defining an opening for supplying the flowable substance to the patient, and means for detecting a leak in said wall means comprising means defining a space contiguous with said wall means for receiving the flowable substance accidentally leaked through said wall means, and a leak indicator medium accommodated in the space responsive to the presence of the leaked-in substance to provide a visible indication that a leak has occurred.

2. A container according to claim 1, wherein said medium is a color change medium.

3. A container according to claim 1, wherein said leak indicator is bonded to the means defining a space.

4. A container according to claim 2, wherein the leak indicator medium is disposed loose inside the means defining a space.

5. A container according to claim 3, wherein said wall mean sand said means defining a space together comprise a double wall structure.

6. A container according to claim 2, wherein said medium is a clouding medium.

7. A container according to claim 6, wherein the clouding medium is a gaseous medium adapted to cloud the space in response to contact with the leaked-in substance.

8. The container of claim 1, further comprising a second chamber normally isolated from said first chamber for containing a second flowable substance, a second communication means for communication from the exterior of the container to said second chamber and means for introducing said second flowable substance to said second chamber to effect the flow of said first flowable substance to the patient.

9. A safety container for administering a flowable substance to a patient comprising a first chamber for containing a first flowable substance, first communication means for communication with sad first chamber, a second chamber normally isolated from said first chamber for container a second flowable substance, second communication means for communication means being adapted to supply the corresponding contained flowable substance to the patient, and a third chamber between first and second chambers and normally out of communication with the first and second chambers and defining a reservoir for the second flowable substance accidentally leaked from the second chamber and thereby avoiding contamination of the first flowable substance in the first chamber by the leaked-in second flowable substance from the second chamber, said third chamber containing a leak detector medium for providing a visual indication that the leak has occurred.

10. A container according to claim 9, wherein said leak detector medium is a color change medium.

11. A container according to claim 9, wherein said leak detector medium is bonded to the means defining a space.

12. A container according to claim 9, wherein the leak indicator medium is disposed loose inside the means defining a space.

13. A container according to claim 9, wherein said leak indicator medium is a clouding medium.

14. A container according to claim 13, wherein the clouding medium is a gaseous medium adapted to cloud the space in response to contact with the leaked-in substance.

15. The safety container of claim 9 wherein the first flowable substance is to be administered to the patient and the introduction of the second flowable substance to the second chamber effects the flow of the first flowable substance from the first chamber to the patient.

16. A container for a flowable substance comprising a first chamber having inlet means for supplying a control flowable substance to said first chamber, a second chamber separate from said first chamber for containing a flowable substance to be supplied, and outlet means for connecting said second chamber to a user, said first and second chambers being defined by flexible wall means, a third chamber disposed between wall means separating said first and second chambers, said third chamber defining a reservoir for the flowable substance from either of the first and second chambers in case of a leak in said wall portion, and said third chamber containing means giving a visible indication of said leak to the exterior.

17. A container according to claim 16, wherein said means giving a visible indication of said leak comprises a leak detector medium.

18. A container according to claim 17, said leak detector medium is a color change medium.

19. A container according to claim 17, wherein said leak detector medium is bonded to the means defining a space.

20. A container according to claim 17, wherein the leak indicator medium is disposed loose inside the means defining a space.

21. A container according to claim 17, said leak indicator medium is a clouding medium.

22. A container according to claim 21, wherein the clouding medium is a gaseous medium adapted to cloud the space in response to contact with the leaked-in substance.

23. The container of claim 16 wherein the introduction of a flowable substance to said first chamber effects the flow of the flowable substance from said second chamber to the patient.

24. A pack for administering a flowable substance to a patient comprising a first, inner chamber for containing a first flowable substance, means for communication between said inner chamber and the surroundings, a second, outer chamber substantially entirely surrounding the first chamber for containing a second flowable substance and means for communication between said second chamber and the surroundings, one of said means for communication being adapted to supply the corresponding contained flowable substance tot he patient, said first and second chambers and their respectively flowable substances being normally entirely out of contact and communication with one another, and a third, sealed intermediate chamber disposed between the inner and outer chambers defining a reservoir for accidentally leaked flowable substance from either one of the first and second chambers, said sealed intermediate chamber containing a leak detector medium.

25. A pack according to claim 24, wherein said leak detector medium is a color change medium.

26. A pack according to claim 24, wherein said leak detector medium is bonded to the means defining a space.

27. A pack according to claim 24, wherein the leak indicator medium is disposed loose inside the means defining a space.

28. A pack according to claim 24, wherein said leak indicator medium is a clouding medium.

29. A pack according to claim 28, wherein the clouding medium is a gaseous medium adapted to cloud the space in response to contact with the leaked-in substance.

30. A pack according to claim 24, wherein walls defining said outer chamber and intermediate chamber are transparent.

31. A pack according to claim 24, wherein all said chambers are defined by flexible and transparent walls.

32. A pack according to claim 24, wherein said first, inner chamber comprises a flexible bag.

33. A pack according to claim 24, wherein said third chamber is defined between a pair of bags of similar configuration inside each other, an inner one of said bags defining the barrier between said first and second chambers and the outer one of the bags defining a barrier between the second and third chambers.

34. A pack according to claim 33, wherein said third chamber has opposed sealed ends, access means for the respective first and second chambers extending through one of said sealed ends, open ends of said bags being sealed at one of said opposed ends.

35. A pack according to claim 24, wherein said first, inner chamber is filled with a flowable substance adapted to be administered to an individual and the second chamber is filled with a flowable substance adapted to control the flow of the flowable substance adapted to be administered.

36. A pack according to claim 24, wherein said third chamber comprises a double wall interface between the first and second chambers containing a leak detector medium.

37. The pack of claim 24, wherein the first flowable substance is to be administered to a patient and the introduction of said second flowable substance to said second chamber effects administration of said first flowable substance to said patient.