IMAGING CARTRIDGE, PIPETTE, AND METHOD OF USE FOR DIRECT SPUTUM SMEAR MICROSCOPY

• US 20160076072A1
• Filed: 04/28/2014
• Published: 03/17/2016
• Est. Priority Date: 04/29/2013
• Status: Active Grant

• Current Assignee: Becton, Dickinson & Co
• Original Assignee: Becton, Dickinson & Co
• Inventors: Nielson, Rex Young, Hayes, Jason Paul, Springer, Matthew James, Belcourt, Lincoln, Solomon, Matthew Daniel, Lastovich, Alexander George, Quinn, Anita, Bell, Pauline Elizabeth, Schram, James Lee
• Granted Patent: US 10,273,523 B2
• Time in Patent Office: Days
• US Class Current: 1/1
• CPC Class Codes: A61B 10/0051 for taking saliva or sputum samples devices for receiving spittle A61J9/00
• CPC Class Codes: B01L 2200/027 for microfluidic devices
• CPC Class Codes: B01L 2200/10 Integrating sample preparation and analysis in single entity, e.g. lab-on-a-chip concept
• CPC Class Codes: B01L 2200/16 Reagents, handling or storing thereof
• CPC Class Codes: B01L 2300/0636 Integrated biosensor, microarrays
• CPC Class Codes: B01L 2300/087 Multiple sequential chambers
• CPC Class Codes: B01L 2400/0481 squeezing of channels or chambers
• CPC Class Codes: B01L 2400/0683 mechanically breaking a wall or membrane within a channel or chamber
• CPC Class Codes: B01L 3/0217 of the plunger pump type medical syringes A61M
• 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: B01L 3/502715 characterised by interfacing components, e.g. fluidic, electrical, optical or mechanical interfaces
• CPC Class Codes: B01L 3/508 rigid containers not provided for above
• 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 1/2813 Producing thin layers of samples on a substrate, e.g. smearing, spinning-on G01N1/30 takes precedence
• CPC Class Codes: G01N 1/30 Staining; Impregnating ; Fixation; Dehydration; Multistep processes for preparing samples of tissue, cell or nucleic acid material and the like for analysis
• CPC Class Codes: G01N 2035/00099 Characterised by type of test elements
• CPC Class Codes: G01N 35/00029 provided with flat sample substrates, e.g. slides G01N35/028 takes precedence

Abstract

An assembly for preparing a specimen is provided that may be configured to determine the presence of at least one microorganism specie in the specimen. The assembly may include a pipette configured to acquire a specimen from a sample and an imaging cartridge configured to be in fluid communication with the pipette. The imaging cartridge and the pipette may be configured to be irreversibly coupled such that the specimen is bio-contained within the imaging cartridge and the pipette when the imaging cartridge and pipette are coupled together. Associated methods of use are also provided.

Claims

1. An assembly for preparing a specimen for determining the presence of at least one microorganism specie in the specimen, the assembly comprising:

a pipette configured to acquire a specimen from a sample wherein the pipette comprises an inlet, a sampling chamber, and a shaft disposed therebetween; and

an imaging cartridge configured to be in fluid communication and irreversibly coupled with the pipette such that the specimen is bio-contained therein wherein the imaging cartridge comprises a pipette dock configured to at least partially receive the pipette shaft therein and irreversibly coupled thereto.

2. The assembly according to claim 1, wherein the microorganism specie includes an acid-fast bacillus.

5. The assembly according to claim 1, wherein the pipette is configured to be in fluid communication with the imaging cartridge upon depression of the sampling chamber.

6. The assembly according to claim 1, wherein the shaft includes at least two graduation marks indicating a minimum and a maximum volume, the graduation marks being configured for measuring an amount of the specimen.

3-4. -4. (canceled)

7. An imaging cartridge for preparing a specimen for determining an amount of at least one microorganism specie, the imaging cartridge comprising:

a pipette dock configured to couple to a pipette containing a specimen such that the specimen is bio-contained therein;

at least one reagent for preparing the specimen for imaging; and

an imaging chamber configured to be in fluid communication with the pipette, wherein the prepared specimen is configured to be spread in the imaging chamber for obtaining an image thereof.

8. The imaging cartridge according to claim 7, further comprising at least one valve disposed between the imaging chamber and the pipette, the at least one valve configured to allow a specimen to flow from the pipette to the imaging cartridge when the pipette is coupled to the imaging cartridge.

9. The imaging cartridge according to claim 7, further comprising at least one channel defined between the imaging chamber and the pipette, the channel configured to provide for fluid communication therebetween.

10. The imaging cartridge according to claim 7, further comprising a cartridge blister chamber in fluid communication with the imaging chamber.

11. The imaging cartridge according to claim 10, wherein the cartridge blister chamber further comprises a cartridge blister, the cartridge blister comprising at least one decolorizer reagent therein.

12. The imaging cartridge according to claim 11, wherein the cartridge blister is configured to release the at least one decolorizer reagent therein when a force is applied to the cartridge blister.

13. The imaging cartridge according to claim 11, wherein the imaging cartridge further comprises a wicking chamber in fluid communication with the imaging chamber, the wicking chamber configured to remove excess decolorizer reagent from the imaging chamber.

14. The imaging cartridge according to claim 7, wherein the imaging cartridge further comprises indicia configured to provide information indicating an amount of specimen provided to the imaging chamber.

15. The imaging cartridge according to claim 7, wherein the imaging cartridge further comprises a porous imaging chamber cover, the porous imaging chamber cover configured to permit the specimen within the imaging chamber to dry and prevent bio-contaminants in the specimen from passing through the imaging chamber cover.

16. The imaging cartridge according to claim 15, wherein the imaging chamber cover comprises a hydrophobic membrane material.

17. The imaging cartridge according to claim 7, further comprising a magnet disposed within the imaging chamber, the magnet configured to move from one end of the imaging chamber to an opposite end of the imaging chamber for spreading the specimen therein.

18. A pipette for obtaining a specimen comprising:

an inlet, a sampling chamber, a shaft disposed therebetween and a pipette sachet disposed within the sampling chamber, wherein the pipette sachet comprises at least one rehydrating reagent; and

at least one staining reagent contained within the sampling chamber, wherein the pipette is configured to draw in a specimen through the inlet and the shaft and into the sampling chamber upon actuation of the sampling chamber.

19. The pipette according to claim 18, wherein the at least one staining reagent is disposed on an interior surface of the sampling chamber and is a dehydrated film of material that comprises at least one of sodium hydroxide, trisodium citrate, N-acetyl-L-cysteine, and Auramine O powder.

23. The pipette according to claim 18, wherein the pipette sachet comprises at least one rehydrating reagent configured to rehydrate the staining compound upon mixing.

24. The pipette according to claim 18, wherein the pipette sachet is configured to release the rehydrating reagent when a force is applied thereto, the force causing the pipette sachet to at least partially rupture.

25. The pipette according to claim 18, wherein the pipette is configured to dispense the specimen out of the inlet upon actuation of the sampling chamber.

26. The pipette according to claim 18, wherein the shaft includes at least two graduation marks indicating a minimum and a maximum volume, the graduation marks being configured for measuring an amount of the specimen.

20-22. -22. (canceled)

27. A method of preparing a specimen for determining the presence of at least one microorganism specie in the specimen, the method comprising:

obtaining a specimen with a pipette;

irreversibly coupling the pipette with an imaging cartridge such that the specimen is bio-contained therein; and

staining the specimen with a staining compound disposed within the pipette by dispensing a desired amount of the stained specimen from the pipette into an imaging chamber defined in the imaging cartridge.

30. The method according to claim 27, further comprising spreading the stained specimen within the imaging chamber.

31. The method according to claim 27, further comprising drying the stained specimen within the imaging chamber.

32. The method according to claim 31, further comprising dispensing a decolorizer reagent into the imaging chamber.

33. The method according to claim 32, further comprising removing excess decolorizer reagent from the imaging chamber.

34. The method of claim 27, further comprising acquiring an image of the specimen in the imaging chamber.

35. The method of claim 27, further comprising determining whether an acid-fast bacilli is present in the specimen.

28-29. -29. (canceled)