Apparatus for clinical laboratory sample collection and automatic sample processing

• US 3,912,455 A
• Filed: 09/07/1973
• Issued: 10/14/1975
• Est. Priority Date: 01/20/1971
• Status: Expired due to Term

• Current Assignee: Eric S. Lichtenstein
• Original Assignee: Eric S. Lichtenstein
• Inventors: Lichtenstein, Eric S.
• Primary Examiner(s): Serwin, R. E.
• Application Number:
  US05/395,214
• Time in Patent Office: 767 Days
• Field of Search: 23/23R,253R,259,592 206/47A,223 128/2F,2G
• US Class Current: 422/430
• CPC Class Codes: A61M 1/16 with membranes
• CPC Class Codes: A61M 1/1656 Apparatus for preparing dialysates
• CPC Class Codes: A61M 1/1668 Details of containers
• CPC Class Codes: A61M 1/1696 with dialysate regeneration
• CPC Class Codes: A61M 1/36226 Constructional details of cassettes, e.g. specific details on material or shape
• 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 2205/123 with incorporated reservoirs
• CPC Class Codes: A61M 2205/125 with incorporated filters
• CPC Class Codes: A61M 2205/126 with incorporated membrane filters
• CPC Class Codes: A61M 2205/3306 Optical measuring means
• CPC Class Codes: A61M 2205/6018 providing set-up signals for the apparatus configuration
• CPC Class Codes: F04B 43/06 Pumps having fluid drive

Abstract

A semi-automatic disposable device of flexible material for receiving a fluid sample and particularly a blood sample, subdividing it into aliquots for sequential processing in conjunction with contained active principles, or reagents, to perform multiple, predesignated analytic procedures. The necessary sequential manipulations are controlled by external means operating through pressurizable passages in said device.

Claims

1. A DISPOSABLE DIVICE FOR RECEIVING BLOOD OR OTHER FLUID AND PHYSIOLOGICAL SAMPLES AND CARRYING OUT DIAGNOSTIC TESTS ON SAID SAMPLES, COMPRISING TWO MAIN SHEETS, AT LEAST ONE OF WHICH IS OF THIN FLEXIBLE PLASTIC, SAID MAIN SHEETS BEGIN SEALED TOGETHER IN A DISTRIBUTION SYSTEM PATTERN INCLUDING JUNCTION MEANS FOR JOINING SAID DISTRIBUTION SYSTEM TO BLOOD-TAKING MEANS FOR RECEIVING BLOOD THEREFROM, A FIRST CHAMBER FOR RECEIVING AND HOLDING A BLOOD SAMPLE OR FLUID DERIVED FROM SAID BLOOD, A FIRST CHANEL CONNECTING SAID FIRST CHAMBER TO SAID JUNCTION MEANS, A SECOND CHAMBER FOR HOLDING A DIAGNOSTIC TEST REAGENT SAID SECOND HAMBER INCORPORATING A BREAKABLE SEAL THROUGH WHICH SAID TEST REAGENT MAY BE RELEASED BY APPLICATION OF PRESSURE, PRESSURE MEANS FOR BREAKING THE SEAL ON SAID SECOND CHAMBER, A THIRD CHAMBER FOR RECEIVING SAID BLOOD SAMPLE AND SAID REAGENT ON BREAKING SAID SEAL, FURTHER CHANNELS CONNECTING SAID FIRST AND SAID SECOND CHAMBER WITH SAID THIRD CHAMBER AND FIRST VALVE MEANS FOR CONTROLLING THE FLOW OF BLOOD OR FLUID FROM SAID FIRST CHAMBER TO SAID THIRD CHAMBER, SAID VALVE MEANS COMPRISING AT LEAST A THIRD SHEET OF FLEXIBLE PLASTIC SEALED TO ONE OF SAID TWO MAIN SHEETS TO FORM A PRESSURIZABLE VALVE PASSAGE CROSSING SAID CHANNEL CONNECTING SAID FIRST AND THIRD CHAMBERS, WHEREBY PRESSURIZING SAID PRESSURIZABLE VALVE PASSAGE RESULTS IN CLOSURE OF SAID CHANNEL CONNECTING SAID FIRST AND THIRD CHAMBERS.

2. The disposable device as defined in claim 1 wherein said distribution system comprises pluralities of first, second and third chambers, where said pluralities are not necessarily equal in number, a manifold header connected to said junction and a branch channel leading from said header to each of said first chambers.

3. The disposable device as defined in claim 1 further comprising second valve means of structure similar to said first valve means, said second valve means being disposed so that it lies across the channel from said junction to said first chamber to control flow of blood to same and to prevent back flow of blood from said first chamber.

4. The disposable device as defined in claim 1 wherein said pressure means is a compartment and a pressurizable passage connected thereto, said compartment overlying a first chaMber, said compartment and pressurizable passage comprising a sheet of flexible plastic sealed to at least one of said two main sheets of said distribution system, said one sheet being flexible, whereby pressurizing said compartment while one of said valve means at a channel connected to said first chamber is unpressurized causes the blood in said first chamber to be essentially completely expelled in a corresponding direction, the combination of a valve in each of two channels connected to a first chamber and a pressurizable compartment having the characteristics of a two-way pump.

5. The disposable device as defined in claim 4, wherein said compartment spans and overlies corresponding first and second chambers, and said breakable seal in said second chamber is positioned at the junction of said second chamber with its connecting channel so that pressurizing said compartment while said valve in said channel leading to the corresponding third chamber is unpressurized results in breakage of said seal and simultaneous transfer of said blood and reagent to said third chamber where reaction can occur.

6. The disposable device as defined in claim 4 wherein said compartment spans and overlies said first and second chambers, and said device further comprises a bag of flexible plastic and test reagent therein, said bag having a seal breakable by application of pressure in said compartment so that pressurizing said compartment while said valve in said channel leading to the corresponding third chamber is unpressurized results in breakage of said seal and simultaneous transfer of said blood and reagent to said third chamber where reaction can occur.

7. The disposable device as defined in claim 5, wherein each of the channels leading from said first and second chambers to the corresponding third chamber has an orifice of selected size therein whereby the relative rates of flow of blood and reagent to said third chamber can be controlled.

8. The disposable device as defined in claim 1 wherein a branch channel leading to a first chamber has therein a filter of controlled porosity for removal of unwanted suspended solid matter.

9. The disposable device as defined in claim 8, wherein said branch channel has therein between said filter and said header a porous plug impregnated with a reagent for reacting with one or more components of blood passing therethrough to form solid matter, said solid matter being removed from the resultant fluid by said filter as said fluid passes therethrough.

10. The disposable device as defined in claim 1, wherein one of said main sheets is essentially rigid.

11. The disposable device as defined in claim 4 wherein both of said main sheets are flexible and at least one of said valves of said pressurizable compartments are formed of two additional sheets of flexible plastic, one of each being sealed to opposite sides of said main sheets, whereby a channel or a chamber may be subjected to pressure from both sides of said main sheets.

12. The disposable device as defined in claim 11, wherein at least one compartment spanning a chamber spans both faces of said chamber and a portion of said two main sheets exterior to said chamber by the use of two additional plastic sheets sealed to said main sheets, and that part of said two main sheets exterior to said spanned chamber and interior to said compartment is apertured, whereby a fluid held at a predetermined temperature may be passed through a pressurizable passage into said compartment on one face of said distribution system, through said aperture and out through the corresponding pressurizable passage on the opposite face of said distribution system, as a means of bringing a blood sample or a reagent or both to a predetermined temperature.

13. The disposable device as defined in claim 1, further comprising a terminal block, and at least one channel leading from one of a first and third chamber to an edge of said distribution system, said terminal block being clampable to said edge of said dIstribution system and having a recess therein at a position corresponding to said one channel leading to said edge, whereby said terminal block provides a closure to said one channel and simultaneously a recess for receiving fluid from a first or a third channel.

14. The disposable device as defined in claim 13 wherein at least one portion of the wall of said recess is of a soft, self-sealing material so that it may be penetrated from the exterior of said block by a hollow needle for taking of fluid from said recess.

15. The disposable device as defined in claim 13 wherein a transparent vessel is held in said recess, said vessel being in a position to receive fluid from said distribution system and the wall of said recess is so apertured to make it possible to pass a light beam through said vessel and fluid contained therein.

16. The disposable device as defined in claim 1, further comprising a terminal block clampable to an edge of said distribution system, said distribution system having a pressurizable passage having an open end at said edge of said distribution system, said terminal block having an aperture therethrough in registry with said open end of said passage, said terminal block further having connecting means for making a fluid-tight connection between said passage and said aperture and between said aperture and an external source of fluid under pressure.

17. The disposable device as defined in claim 12, wherein both of a pair of compartment passages connected to one compartment have an open end proximate but not at an edge of said distribution system, said pair of compartment passages are in registry with each other on opposite faces of said main sheets, said distribution system further comprises a pair of hollow, resilient half-cylinders positioned in said open ends of said compartment passages to hold same open, and said device further comprises a terminal block adapted for clamping to said edge, said block having a matched pair of apertures therethrough, and a pair of first connecting means for connecting each of said apertures to one of said compartment passages and a pair of second connecting means for connecting one of said apertures to a pressurized source of fluid and the other of said apertures to a sink.

18. The disposable device as defined in claim 4 wherein said compartment spans and overlies said first and second chambers and said device further comprises a sealed bag containing reagent, said sealed bag being within said second chamber and having a region weak enough so that pressure exerted by said compartment can rupture said bag, thereby forcing said reagent toward said third chamber through a channel connecting said second and third chambers.

19. The disposable device as defined in claim 4 wherein said distribution system includes three channels two of which lie on either side of a central channel, and a tube connecting said two channels and crossing through said central channel, said tube having an aperture proximate either end and passing through said central channel without fluid interconnection therebetween, thereby making it possible to connect two channels across a central channel for sensing pressure or other characteristics of fluid in said central channel without changing the composition of said fluid.

20. The disposable device as defined in claim 1 further comprising a pair of electrodes sealed into at least one of a channel or chamber for measuring the electrical conductivity thereof.

21. The disposable device as defined in claim 1 further comprising conductive metal on either side of a channel for measuring the capacitance of the fluid therein.

22. The disposable device as defined in claim 1 further comprising at least one one-way valve means in a channel for preventing back-flow of blood or fluid.

23. The disposable device as defined in claim 11 wherein said main sheets and two additional sheets are sufficiently flexible to permit rolling said device into a cylinder for storage in a container.

24. The disposable device as defined in claim 1 wherein said third sheet is essentially coextensive with said main sheets.

25. The disposable device as defined in claim 4 wherein said third sheet is wide enough only to form said passages and said compartment, said third sheet being sealed to one of said main sheets in the formation of said passages and compartment.

26. A disposable device for taking fluid from a patient and for carrying out diagnostic tests on said fluid, comprising valves, ducts, reservoirs and pumps, at least part of said valves, ducts, reservoirs and pumps being formed of a first pair of flexible plastic sheets joined together in a first pattern including interconnected ducts and chambers, and inlets and outlets for connecting said ducts and chambers with exterior sources of fluid and drains and at least a third flexible plastic sheet joined to said first pair in a second pattern such that at least one pressurizable channel between said third sheet and said first pair of sheets crosses a duct between said first pair of sheets, pressurization of said channel serving to close said duct at said crossing of said duct and said channel, the combination of duct and channel thereby functioning as a valve, said second pattern further being such that a pressurizable region between said third sheet and said first pair of sheets overlies a chamber between said first pair of sheets, said chamber having an input duct and an output duct connected therewith, pressurization of said region serving to expel liquid through one of said input and said output ducts when said one duct is functioning as a valve, whereby the combination of said pressurizable region with said chamber and said pressurizable channel with said duct functions as a pump.