Method and device for cytology and microbiological testing

• US 5,139,031 A
• Filed: 04/08/1991
• Issued: 08/18/1992
• Est. Priority Date: 09/18/1989
• Status: Expired due to Term

• Current Assignee: Sonabank (432804) (Primis Financial Corp.)
• Original Assignee: La MINA Limited
• Inventors: Guirguis, Raouf A.
• Primary Examiner(s): HINDENBURG, MAX F
• Application Number:
  US07/680,896
• Time in Patent Office: 498 Days
• Field of Search: 128/760, 128/762, 128/771, 604/318, 604/404, 604/406, 422/56, 422/60
• US Class Current: 600/584
• CPC Class Codes: A61B 10/0045 Devices for taking samples of body liquids devices for taking blood samples A61B5/15
• CPC Class Codes: A61B 10/007 for taking urine samples measuring urological functions A61B5/20; genital receptacles A61F5/451; urinals for bed-ridden persons A61G9/006
• CPC Class Codes: A61B 5/15003 for venous or arterial blood
• CPC Class Codes: A61B 5/150229 Pumps for assisting the blood sampling
• CPC Class Codes: A61B 5/150236 Pistons, i.e. cylindrical bodies that sit inside the syringe barrel, typically with an air tight seal, and slide in the barrel to create a vacuum or to expel blood
• CPC Class Codes: A61B 5/150389 Hollow piercing elements, e.g. canulas, needles, for piercing the skin
• CPC Class Codes: A61B 5/150519 Details of construction of hub, i.e. element used to attach the single-ended needle to a piercing device or sampling device
• CPC Class Codes: A61B 5/150755 Blood sample preparation for further analysis, e.g. by separating blood components or by mixing
• CPC Class Codes: A61B 5/153 Devices specially adapted for taking samples of venous or arterial blood, e.g. with syringes
• CPC Class Codes: B01L 3/502 with fluid transport, e.g. in multi-compartment structures centrifugal-type cuvettes G01N21/07; analysis by separation into components G01N30/00; automatic analysers G01N35/00
• CPC Class Codes: C12Q 1/24 Methods of sampling, or inoculating or spreading a sample; Methods of physically isolating an intact microorganisms
• CPC Class Codes: G01N 1/4077 by other techniques involving separation of suspended solids
• CPC Class Codes: G01N 2001/4027 evaporation leaving a concentrated sample
• CPC Class Codes: G01N 33/54366 Apparatus specially adapted for solid-phase testing

Abstract

The present invention is directed towards an apparatus and a method which can use immunoassay in sample treatment apparatus for diagnostic and testing purposes of dialysis fluid or urine by concentrating the urinary sediments on a first membrane and concentrating bacteria on a second membrane. Urine is transported through the tubular container under pressure to flow through the sample container which separately screens off the urinary sediments and the bacteria for collection and testing.

Claims

1. An apparatus for collecting cellular components and biological specimens from a fresh unpreserved body fluid for cytology and pathogen testing comprising a syringe, a plurality of specimen collection containers stacked together in fluid communication with said syringe, each specimen collection container comprising a two-piece housing comprising a male member and a female member removably mounted together, a membrane filter means is mounted in said male member adjacent a housing chamber defined by said male member, said membrane filter means allowing biologicaI fluid flow therethrough while concentrating biological components on said membrane filter means, said membrane filter means being easily accessible for removal of the biological components collected thereon.

2. An apparatus for testing as claimed in claim 1 wherein each membrane filter means in each specimen collection container has a larger porosity than the membrane filter means in the next downstream specimen collection container.

3. An apparatus for testing as claimed in claim 1 wherein said first specimen collection container has a luer lock on one of its two-piece housing members and a nipple means adapted to be mounted into a luer lock on the other of its two-piece housing members.

4. An apparatus for testing as claimed in claim 1 wherein said male member comprises a base, a cylindrical wall extending outward from said base, an interior wall means extending outward from said base positioned inside said cylindrical wall, said interior wall means defining a membrane filter seat and a chamber adjacent said filter seat, a nipple means with a throughgoing bore extends outward from said base in the opposite direction from said cylindrical wall and said interior wall means with the throughgoing bore communicating with said interior wall means chamber.

5. An apparatus for testing as claimed in claim 4 wherein said interior wall means has a stepped end wall.

6. An apparatus for testing as claimed in claim 5 wherein said interior wall means stepped end wall defines an annular groove.

7. An apparatus for testing as claimed in claim 4 wherein said cylindrical wall has a threaded outer surface.

8. An apparatus for testing as claimed in claim 4 wherein said cylindrical wall engages said base to form a lip.

9. An apparatus for testing as claimed in claim 1 wherein said female member comprises a base means, a cylindrical wall extending outward from said base means, said base means defining a membrane filter seat and with the cylindrical wall defining a chamber adjacent said filter seat, a luer lock means with a throughgoing bore extends outward from said base means in the opposite direction from said cylindrical wall with said throughgoing bore communicating with said chamber.

10. An apparatus for testing as claimed in claim 9 wherein said cylindrical wall has a threaded inner surface.

11. An apparatus for testing as claimed in claim 9 wherein said base means is provided with prong means extending into said chamber for seating in an annular groove in the end wall of the inner wall means of the male member.

12. An apparatus for testing as claimed in claim 1 wherein said body fluid is preserved.

13. An apparatus for collecting bacteria and urinary sediments from a human fluid sample comprising a pump means, a plurality of specimen collection containers removably mounted to each other while allowing fluid passage therethrough, one of said specimen collection containers being mounted to said pump means, each of said specimen collection containers comprising a housing provided with connector means allowing the housing to be connected to other specimen collection containers, said housing comprising two mateable sections, one of said housing sections defining a chamber, a filter membrane seat defined in said one housing section positioned adjacent said chamber and a filter membrane mounted in said membrane seat, the other housing section being removably mounted to the first housing section so that said housing sections can be opened for access to the filter membrane, said other housing section including filter membrane positioning means which keeps said filter membrane in position on said filter membrane seat and defining a throughgoing bore which is adapted to hold and seat a needle, each filter membrane which is downstream of the previous filter membrane having a smaller pore size then the prior upstream filter membrane with at least one of said filter membranes retaining cellular sediments from said human fluid sample and at least one of said filter membranes retaining bacteria from said human fluid sample.

14. An apparatus as claimed in claim 13 wherein said housing is provided with a luer lock means on one section and attachment means on the other section which is adapted to be secured to a lure lock means.

15. An apparatus as claimed in claim 13 wherein said filter membrane positioned upstream from a filter membrane of smaller pore size has a five micron pore size to trap polymorphnuclear leukocytes.

16. An apparatus as claimed in claim 15 wherein said filter membrane also traps lymphocytes.

17. An apparatus as claimed in claim 15 wherein said filter membrane is constructed of polycarbonate.

18. An apparatus as claimed in claim 15 wherein said filter membrane is constructed of nylon.

19. An apparatus as claimed in claim 13 wherein said filter membrane positioned downstream from a filter membrane of larger pore size has a 0.45 micron pore size to trap bacteria.

20. An apparatus as claimed in claim 19 wherein said filter membrane is constructed of nitrocellulose.

21. An apparatus as claimed in claim 13 wherein said human fluid sample is preserved.

22. An apparatus as claimed in claim 13 wherein said human fluid sample is unpreserved.

23. An apparatus for testing for cellular specimens and bacteria in a biological fluid comprising a pump means, a plurality of specimen collection units serially mounted to said pump means for selective removal from each other and said pump means, each said specimen collection unit comprising a separable sectional housing with an inlet and outlet means, said inlet and outlet means additionally serving as connection means with other specimen collection units, a filter membrane means mounted in said housing in one of said housing sections allowing fluid flow therethrough by said biological fluid while selectively retaining either cellular specimens or bacteria dependent upon the pore size of the membrane filter, each filter membrane means in each specimen collection unit has a larger porosity than the filter membrane means in the next downstream specimen collection container.

24. An apparatus for testing as claimed in claim 23 wherein one section of said sectional housing comprises a base, a cylindrical wall extending outward from said base, an interior wall means extending outward from said base positioned inside said cylindrical wall, said interior wall means defining a membrane filter seat and a chamber adjacent said filter seat, a nipple means with a throughgoing bore extends outward from said base in the opposite direction from said cylindrical wall and said interior wall means with the throughgoing bore of the nipple means communicating with said interior wall means chamber.

25. A method of testing for collecting different biological specimens from biological fluid comprising the steps of:

a. collecting a biological fluid into a container;

b. passing the biological fluid through a series of separate removably connected sectioned filter containers causing different preselected biological components in the biological fluid to be deposited on membrane filter means held in each sectioned filter container with one of said sectioned filter containers trapping cellular components from the biological fluid;

c. removing one of the containers which traps the cellular components from the series of separate connected removable sectioned filter containers and opening the filtered sectioned container to provide access to the membrane filter means with trapped cellular components contained therein; and

d. applying the filter membrane surface to a slide depositing cells on said slide.

26. A method as claimed in claim 25 including the additional step after step c. of preserving the cellular components.

27. A method as claimed in claim 25 including the additional step e. of microscopically examining the deposited cells on said slide.

28. A method of testing for collecting different biological specimens from human body fluid comprising the steps of:

a. collecting a human body fluid into a container;

b. passing the human body fluid through a series of separate removably connected sectioned filter containers causing different preselected biological components in the human body fluid to be deposited on membrane filter means held in each sectioned filter container with one of said sectioned filter containers trapping cellular components from the human body fluid;

c. removing one of the containers which traps the cellular components from the series of separate connected removable sectioned filter containers and opening the filtered sectioned container to provide access to the membrane filter means with trapped cellular components contained therein; and

d. applying the filter membrane surface to a slide depositing fresh unpreserved cells on said slide.

29. A method as claimed in claim 28 including the additional step e. of microscopically examining the deposited cells on said slide within two hours after the addition of the fresh unpreserved cells to said slide.

30. A method of testing for predetermined biological specimens in a biological fluid comprising the steps of:

a. collecting a biological fluid into a container;

b. passing the biological fluid through a series of separate removably connected sectioned filter containers causing different preselected biological components in the biological fluid to be deposited on membrane filter means held in each sectioned filter container with one of said sectioned filter containers trapping bacteria from the biological fluid;

c. removing the container which traps bacteria from the series of separate connected removable sectioned filter containers and opening the filtered sectioned container to provide access to the membrane filter means with trapped bacteria contained therein;

d. eluting the trapped bacteria from the membrane filter means into a microbiological culture plate; and

e. incubating the bacteria into an identifiable bacterial colony.

31. A method of testing for predetermined biological specimens in a biological fluid comprising the steps of:

a collecting a biological fluid into a container;

b. passing the biological fluid through a series of separate removably connected sectioned filter containers causing different preselected biological components in the biological fluid to be deposited on membrane filter means held in each sectioned filter container with one of said sectioned filter containers trapping bacteria from the biological fluid;

c. removing the container which traps bacteria from the series of separate connected removable sectioned filter containers and opening the filtered sectioned container to provide access to the membrane filter means with trapped bacteria contained therein;

d. eluting the trapped bacteria into a Qualture capsule; and

e. incubating the bacterial in the Qualture capsule into an identifiable bacterial colony.

32. A method as claimed in claim 31 including the additional step f. of microscopically examining the bacterial colony.

33. A method of testing for predetermined biological specimens in a preserved biological fluid comprising the steps of:

a. collecting a preserved biological fluid into a container;

b. passing the preserved biological fluid through a series of separate removably connected sectioned filter containers causing different preselected biological components in the preserved biological fluid to be deposited on membrane filter means held in each sectioned filter container with one of said sectioned filter containers trapping bacteria from the preserved biological fluid;

c. removing the container which traps bacteria from the series of separate connected removable sectioned filter containers and opening the filtered sectioned container to provide access to the membrane filter means with trapped bacteria contained therein;

d. eluting the trapped bacteria from the membrane filter means onto a slide; and

e. microscopically examining the deposited bacteria on said slide.