Prepackaged fluid processing module having pump and valve elements operable in response to applied pressures

• US 4,479,762 A
• Filed: 12/28/1982
• Issued: 10/30/1984
• Est. Priority Date: 12/28/1982
• Status: Expired due to Term

• Current Assignee: Baxter Travenol Laboratories Incorporated (Baxter International Inc.)
• Original Assignee: Baxter Travenol Laboratories Incorporated (Baxter International Inc.)
• Inventors: Bilstad, Arnold C., Brown, Richard I., Kruger, Robert J.
• Primary Examiner(s): Smith, Leonard E.
• Application Number:
  US06/453,926
• Time in Patent Office: 672 Days
• Field of Search: 417/394, 417/395, 417/479, 417/480, 417/510, 128/DIG. 3, 128/DIG. 12, 604/4, 604/5, 604/6, 604/152, 604/153, 604/246, 206/570, 206/571, 206/572, 206/364, 206/365, 206/366
• US Class Current: 417/395
• CPC Class Codes: A61M 1/30 Single needle dialysis ; Reciprocating systems, alternately withdrawing blood from and returning it to the patient, e.g. single-lumen-needle dialysis or single needle systems for hemofiltration or pheresis
• CPC Class Codes: A61M 1/306 Pressure control, e.g. using substantially rigid closed or gas buffered or elastic reservoirs
• CPC Class Codes: A61M 1/3496 Plasmapheresis; Leucopheresis; Lymphopheresis A61M1/3472 takes precedence
• CPC Class Codes: A61M 1/362227 the interface providing means for actuating on functional elements of the cassette, e.g. plungers
• CPC Class Codes: A61M 1/36224 with sensing means or components thereof
• CPC Class Codes: A61M 1/36225 with blood pumping means or components thereof
• CPC Class Codes: A61M 1/362261 at least one cassette surface or portion thereof being flexible, e.g. the cassette having a rigid base portion with preformed channels and being covered with a foil
• CPC Class Codes: A61M 1/362262 Details of incorporated reservoirs
• CPC Class Codes: A61M 1/362264 the filter being a blood filter
• CPC Class Codes: A61M 1/362265 Details of valves
• CPC Class Codes: A61M 1/362266 Means for adding solutions or substances to the blood
• CPC Class Codes: A61M 1/3623 Means for actively controlling temperature of blood
• CPC Class Codes: A61M 2205/12 with interchangeable cassettes forming partially or totally the fluid circuit
• CPC Class Codes: A61M 2205/123 with incorporated reservoirs
• CPC Class Codes: A61M 2205/128 with incorporated valves
• CPC Class Codes: A61M 60/113 in other functional devices, e.g. dialysers or heart-lung machines
• CPC Class Codes: A61M 60/148 in line with a blood vessel using resection or like techniques, e.g. permanent endovascular heart assist devices
• CPC Class Codes: A61M 60/37 Haemodialysis, haemofiltration or diafiltration
• CPC Class Codes: A61M 60/427 the force acting on the blood contacting member being hydraulic or pneumatic
• CPC Class Codes: A61M 60/43 using vacuum at the blood pump, e.g. to accelerate filling
• CPC Class Codes: A61M 60/849 : Disposable parts
• CPC Class Codes: A61M 60/851 : Valves

Abstract

A disposable prepackaged fluid processing module includes an integral housing wherein fluid containers, tubing segments, and other components required in processing a fluid are contained. Fluid communication between the containers, components and tubing segments is provided by a fluid circuit formed by a panel of the housing, and an overlying fluid-impermeable flexible sheet member. The fluid circuit includes pump and valve elements which operate in response to pressures applied to the sheet member. Upon installation of the system in a related actuator apparatus pneumatic actuator ports apply pressures to the pump and valve elements to circulate fluid through the fluid circuit.

Claims

1. A fluid module for use in a fluid procedure, comprising:

a housing open at one end, including a removable cover overlying said open end; and

a relatively flexible fluid impervious sheet member within said housing forming in conjunction with said housing a fluid circuit including at least one pump element actuable in response to an applied pressure.

2. A fluid module as defined in claim 1 wherein said cover is peelably removable from said housing.

3. A fluid module as defined in claim 1 wherein said housing comprises a base panel and at least one side panel forming an open ended tray-like enclosure, and said fluid circuit is formed in conjunction with said base panel.

4. A fluid module as defined in claim 1 or 3 wherein said one pump element is responsive to a force applied to said flexible sheet member for urging fluid through said fluid circuit.

5. A fluid module as defined in claim 4 wherein said force is a pressure force.

6. A fluid module as defined in claim 1 wherein said fluid circuit is a single-use circuit, and said housing and said fluid circuit are disposable.

7. A fluid module as defined in claim 1

wherein said housing includes a panel member formed of a relatively inflexible fluid-impermeable material and including a generally outwardly depressed portion therein;

and

wherein said relatively flexible fluid impervious sheet member overlies said panel member in fluid-sealed engagement therewith, said sheet member forming in conjunction with said depressed portion said fluid circuit which serially includes a fluid passageway and said at least one pump element responsive to said pressure applied to said flexible sheet member for controlling fluid flow in said passageway.

8. A fluid module as defined in claim 1 or 7 wherein said one pump element is actuable by a pneumatic pressure force applied to said sheet member.

9. A fluid circuit as defined in claim 8 wherein said force is applied by actuator means at a predetermined location on said sheet member and wherein said base panel comprises alignment means for maintaining said sheet member location in operative alignment with said actuator means.

10. A fluid module as defined in claim 1

wherein said housing includes a relatively stiff fluid-impermeable base member including a raised portion thereon forming said one pump element having an inlet valve stop, an outlet valve stop, and a fluid displacement chamber being generally arranged for continuous fluid flow therethrough;

wherein said relatively flexible fluid impervious sheet member overlies said base member in fluid-sealed arrangement therewith, and forms in conjunction with said raised portion of said base member said fluid circuit which serially includes a fluid passageway and said pump element; and

wherein said flexible sheet member is displaceable against said inlet and outlet valve stops by pressure applied to said sheet member for closing said valve stops, and is displaceable into said fluid displacement chamber for forcing fluid along said passageway.

11. A fluid module as defined in claim 10 wherein at least one of said valve stops extends in close proximity to said flexible sheet member to form a normally partially closed valve requiring outward deflection of said flexible sheet member to fully open said valve enabling fluid passage along said passageway.

12. A fluid module as defined in claim 11 wherein both of said valve stops extend in close proximity to said flexible sheet member to form normally partially closed valves each requiring outward deflection of said flexible sheet member to fully open said valves enabling fluid passage along said passageway.

13. A fluid module as defined in claim 10 wherein at least one of said valve stops is spaced away from said flexible sheet member in the undeflected position to form a normally open valve requiring inward deflection of said flexible sheet member to close said valve.

14. A fluid module as defined in claim 13 wherein both of said valve stops are spaced away from said flexible sheet member in the undeflected position to form normally open valves requiring inward deflection of said flexible sheet member to close said valves.

22. A fluid module as defined in claim 11 wherein said base panel is relatively stiff and includes an outwardly deformed portion forming in conjunction with said overlying sheet member said fluid circuit, and wherein said overlying sheet member is relatively flexible, and wherein said fluid circuit includes a circuit element actuable by a force applied to said sheet member.

23. A fluid module as defined in claim 22 wherein said applied force comprises a pressure.

24. A fluid module as defined in claim 23 wherein said pressure differential is applied by actuator apparatus external to said housing, and said side panel includes at least one aperture facilitating pressure communication between said actuator apparatus and said flexible sheet member.

15. A modular fluid processing system for use in a fluid procedure, comprising:

a housing have a base panel and at least one side panel;

at least one system element contained within said housing for use in conjunction with the procedure; and

a fluid-impermeable sheet member within said housing overlying said base panel, and forming in conjunction with said base panel a fluid circuit in fluid communication with said component.

16. A fluid module as defined in claim 15 wherein said cover is open at at least one end, and includes a removable cover overlying said open end.

17. A fluid module as defined in claim 16 wherein said cover is peelably removable from said housing.

18. A fluid module as defined in claim 15 wherein said sheet member is relatively flexible, and said fluid circuit includes a circuit element responsive to an applied force for forcing fluid through said circuit.

19. A fluid module as defined in claim 18 wherein said fluid circuit includes a filter element.

20. A fluid module as defined in claim 18 wherein said circuit element is responsive to displacement of a portion of said overlying fluid-impermeable sheet member in response to an applied pneumatic pressure differential.

21. A fluid module as defined in claim 20 wherein said circuit element comprises a pump element for urging fluid through said circuit.

25. A fluid module for fractionating a desired fluid component from a whole fluid, said module comprising, in combination

a housing having a base panel and at least one side panel;

a filter element for separating the desired component from the whole component; and

a fluid-impervious sheet member within said housing overlying said bottom panel, said bottom panel including a depressed portion forming in conjunction with said overlying sheet member a fluid circuit serially including said filter element.

26. A fluid module as defined in claim 25 wherein said housing is open at one end and includes a removable cover enclosing said housing.

27. A fluid module as defined in claim 26 wherein said cover is peelably removable from said housing.

28. A fluid module as defined in claim 25 wherein said base panel is outwardly deformed to form in conjunction with said overlying sheet member a filter chamber, and wherein said filter element is disposed within said chamber.

29. A fluid module as defined in claim 28 wherein said filter element comprises a hollow-fiber filter element.

30. A fluid module as defined in claim 25, wherein said housing contains a container for fluid involved in the fractionation procedure, and said fluid circuit is in fluid communication with said container.

31. A fluid module as defined in claim 25 wherein said housing and said sheet member are disposable members formed of a plastic material.

32. A modular fluid system for performing a fluid procedure, comprising:

a housing open at one end and including a base panel and at least one side panel formed of a relatively inflexible fluid-impermeable plastic material;

a system component contained within said housing for use in conjunction with said fluid procedure;

a relatively flexible fluid-impermeable sheet member overlying said base panel, said base panel including an outwardly depressed portion thereon forming in conjunction with said sheet member a fluid-sealed fluid circuit including a circuit element actuable by force applied to said sheet member; and

removable cover means overlying the open end of said housing.

33. A fluid module as defined in claim 32 wherein said circuit element comprises a pump element actuable by pressure applied to said flexible sheet member.

34. A fluid module as defined in claim 33 wherein said side panel includes an access aperture to facilitate application of pressure to said sheet member.

35. A fluid module as defined in claim 32 wherein said system container is connected in fluid communication with said fluid circuit, and removable from said housing through said open end.

36. A fluid module for use in a fluid procedure comprising

a housing comprising a base panel and at least one side panel forming an open ended tray-like enclosure, and

a relatively flexible fluid impervious sheet member within said housing forming in conjunction with said base panel a fluid circuit including at least one pump element actuable in response to an applied pressure.

37. A fluid module as defined in claim 36 and further including a cover over said open end for closing said housing.

38. A fluid module as defined in claim 37 wherein said cover is peelably removable from said housing.

39. A fluid module as defined in claim 36 wherein said one pump element is responsive to a force applied to said flexible sheet member for urging fluid through said fluid circuit.

40. A fluid module as defined in claim 36

wherein said base panel is formed of a relatively inflexible fluid-impermeable material and includes a generally outwardly depressed portion therein;

and

wherein said relatively flexible fluid impervious sheet member overlies said base panel in fluid-sealed engagement therewith, said sheet member forming in conjunction with said depressed portion said fluid circuit which serially includes a fluid passageway and said at least one pump element responsive to said pressure applied to said flexible sheet member for controlling fluid flow in said passageway.

41. A fluid module as defined in claim 39 or 40

wherein said one pump element is actuable by a pneumatic pressure force applied to said sheet member.

42. A fluid module as defined in claim 36

wherein said base panel includes a raised portion thereon forming said one pump element having an inlet valve stop, an outlet valve stop, and a fluid displacement chamber being generally arranged for continuous fluid flow therethrough;

wherein said relatively flexible fluid impervious sheet member overlies said base panel in fluid-sealed arrangement therewith, and forms in conjunction with said depressed portion of said base panel said fluid circuit which serially includes a fluid passageway and said pump element; and

wherein said flexible sheet member is displaceable against said inlet and outlet valve stops by pressure applied to said sheet member for closing said valve stops, and is displaceable into said fluid displacement chamber for forcing fluid along said passageway.

43. A fluid module as defined in claim 42

wherein at least one of said valve stops extends in close proximity to said flexible sheet member to form a normally partially closed valve requiring outward deflection of said flexible sheet member to fully open said valve enabling fluid passage along said passageway.

44. A fluid module as defined in claim 43

wherein both of said valve stops extend in close proximity to said flexible sheet member to form normally partially closed valves each requiring outward deflection of said flexible sheet member to fully open said valves enabling fluid passage along said passageway.

45. A fluid module as defined in claim 42

wherein at least one of said valve stops is spaced away from said flexible sheet member in the undeflected position to form a normally open valve requiring inward deflection of said flexible sheet member to close said valve.

46. A fluid module as defined in claim 45

wherein both of said valve stops are spaced away from said flexible sheet member in the undeflected position to form normally open valves requiring inward deflection of said flexible sheet member to close said valves.