DISPOSABLE CHAMBER FOR ANALYZING BIOLOGIC FLUIDS

• US 20150323519A1
• Filed: 07/20/2015
• Published: 11/12/2015
• Est. Priority Date: 04/07/2004
• Status: Active Grant

• Current Assignee: Abbott Laboratories Incorporated
• Original Assignee: Abbott Laboratories Incorporated
• Inventors: Wardlaw, Stephen C.
• Granted Patent: US 10,578,602 B2
• Time in Patent Office: Days
• US Class Current: 1/1
• CPC Class Codes: B01L 2200/025 Align devices or objects to ensure defined positions relative to each other
• CPC Class Codes: B01L 2200/12 Specific details about manufacturing devices
• CPC Class Codes: B01L 2300/0877 Flow chambers
• CPC Class Codes: B01L 2300/0887 Laminated structure
• CPC Class Codes: B01L 2400/0406 capillary forces
• CPC Class Codes: B01L 3/5027 by integrated microfluidic structures, i.e. dimensions of channels and chambers are such that surface tension forces are important, e.g. lab-on-a-chip B01L3/5023 takes precedence; micromixers B01F33/30; microreactors for synthesis B01J19/0093; microcapillary devices in general B81B1/00
• CPC Class Codes: B01L 3/502738 characterised by integrated valves microvalves F16K99/0001
• CPC Class Codes: G01N 1/2813 Producing thin layers of samples on a substrate, e.g. smearing, spinning-on G01N1/30 takes precedence
• CPC Class Codes: G01N 1/312 for samples mounted on planar substrates
• CPC Class Codes: G01N 1/36 Embedding or analogous mounting of samples
• CPC Class Codes: G01N 2015/016 White blood cells
• CPC Class Codes: G01N 2015/1006 for cytology
• CPC Class Codes: G01N 2015/1486 Counting the particles
• CPC Class Codes: G01N 2021/0346 Capillary cells; Microcells
• CPC Class Codes: G01N 2021/0364 flexible, compressible
• CPC Class Codes: G01N 21/03 Cuvette constructions
• CPC Class Codes: G01N 33/48764 Test tape taken off a spool
• CPC Class Codes: G01N 33/492 Determining multiple analytes
• CPC Class Codes: G01N 35/00009 provided with a sample supporting tape, e.g. with absorbent zones
• CPC Class Codes: G02B 21/34 Microscope slides, e.g. mounting specimens on microscope slides
• CPC Class Codes: Y10T 436/101666 : Particle count or volume standard or control [e.g., platelet count standards, etc.]
• CPC Class Codes: Y10T 436/25375 : Liberation or purification of sample or separation of material from a sample [e.g., filtering, centrifuging, etc.]

Abstract

An apparatus for analyzing biologic fluid is provided that includes a first planar member, a second planar member, and at least three separators. At least one of planar members is transparent. The separators are disposed between the members, and separate the members to form a chamber having a height. At least one of the members or separators is sufficiently flexible to permit the chamber height to approximate the mean size of the separators. During use, the biologic fluid to be analyzed is disposed within the chamber.

Claims

1. An apparatus for analyzing biologic fluid, comprising:

a tape including a first planar member and a second planar member spaced apart from one another and bonded together at discrete points, wherein at least one of the first planar member and second planar member is transparent, and a plurality of chambers, each having a height, are formed between the planar members, and at least three separators are disposed in each of the chambers, and wherein at least one of the first planar member, second planar member, or separators is flexible to permit the chamber height to be substantially uniform;

a source reel on which the tape may be wound; and

a take-up reel on which the tape may be wound.

2. The apparatus of claim 1, wherein one of the separators, first planar member, and second planar member, has a greater flexibility relative to at least one of the others of the separators, first planar member, and second planar member.

3. The apparatus of claim 2, wherein the first planar member has a greater flexibility than the second planar member and the separators.

4. The apparatus of claim 1 wherein at least one of the first planar member and the second planar member comprise flexible plastic.

5. The apparatus of claim 1, wherein the separators are attached to at least one of the first planar member or the second planar member.

6. The apparatus of claim 1 wherein one of the first planar member or the second planar member comprises linked rigid elements and the other of the first planar member or second planar member comprises flexible plastic.

7. The apparatus of claim 1, wherein the separators are independent of the first planar member and second planar member, and are randomly distributed within each chamber.

8. The apparatus of claim 1, wherein each separator individually has a height and the separators collectively having a mean height;

and

wherein the separators are independent of the first planar member and second planar member, and are randomly distributed within each chamber; and

wherein at least one of the first planar member, second planar member, or separators is sufficiently flexible when the first planar member and second planar member are drawn toward each other by capillary force from a biologic fluid quiescently residing within the chamber to cause a mean chamber height to be substantially equal to the mean height of the separators.

9. The apparatus of claim 1, wherein the number of separators randomly disposed in a given area of at least one of the chambers is such that additional separators of the same type do not appreciably change the chamber height within the area.

10. The apparatus of claim 1, wherein the separators within at least one of the chambers have a concentration, and the number of separators randomly disposed within that chamber is such that increasing the concentration does not appreciably change the chamber height.

16. The apparatus of claim 1, wherein a plurality of chambers are formed between the planar members downstream of the nip-rollers, and at least three separators are disposed within each chamber, and the separators are independent of the first planar member and second planar member, and are randomly distributed within each chamber.

17. The apparatus of claim 1, wherein a plurality of chambers are formed between the planar members downstream of the nip-rollers, and at least three separators are disposed within each chamber, and

wherein each separator individually has a height and the separators within a chamber collectively have a mean height;

and

wherein the separators are independent of the first planar member and second planar member, and are randomly distributed within each chamber; and

wherein at least one of the first planar member, second planar member, or separators is sufficiently flexible when the first planar member and second planar member are drawn toward each other by capillary force from a biologic fluid quiescently residing within the chamber to cause a mean chamber height to be substantially equal to the mean height of the separators.

18. The apparatus of claim 17, wherein the number of separators randomly disposed in a given area of at least one of the chambers is such that additional separators of the same type do not appreciably change the chamber height within the area.

19. The apparatus of claim 17, wherein the separators within at least one of the chambers have a concentration, and the number of separators randomly disposed within that chamber is such that increasing the concentration does not appreciably change the chamber height.

11. An apparatus for analyzing biologic fluid, comprising:

a first planar member;

a first source reel;

a second planar member, wherein at least one of the first planar member and second planar member is transparent,

a second source reel;

a plurality of separators attached to one of the first planar member or second planar;

a pair of nip-rollers spaced apart from one another an amount that causes the first planar member and second planar member to be in contact with substantially all of the separators when the planar members are drawn between the nip-rollers;

at least one chamber having a height, which chamber is formed between the planar members downstream of the nip-rollers, and wherein at least one of the first planar member, second planar member, or separators is flexible to permit the chamber height to be substantially uniform; and

at least one take-up reel for receiving one or both of the planar members.

12. The apparatus of claim 11, wherein one of the separators, first planar member, and second planar member, has a greater flexibility relative to at least one of the others of the separators, first planar member, and second planar member.

13. The apparatus of claim 12, wherein the first planar member has a greater flexibility than the second planar member and the separators.

14. The apparatus of claim 11 wherein at least one of the first planar member and the second planar member comprise flexible plastic.

15. The apparatus of claim 11, wherein the separators are attached to at least one of the first planar member or the second planar member.

20. A method of enumerating the cellular or particulate constituents of a sample of whole, anticoagulated blood, comprising the steps of:

providing a tape including a first planar member and a second planar member spaced apart from one another and bonded together at discrete points, wherein at least one of the first planar member and second planar member is transparent, and at least one chamber having a height is formed between the planar members, and at least three separators are disposed in each of the at least one chamber, and wherein at least one of the first planar member, second planar member, or separators is flexible to permit the chamber height to be substantially uniform, and a source reel on which the tape may be wound, and a take-up reel on which the tape may be wound;

depositing a quantity of biologic fluid into the at least one chamber;

determining the volume of biologic fluid contained within at least a portion of the at least one chamber;

directly or indirectly enumerating all constituents of interest within substantially the volume of biologic fluid; and

expressing the enumerated constituents as a count per unit volume.