Method and apparatus for detecting amine producing organisms in the vagina

• US 5,827,200 A
• Filed: 01/27/1997
• Issued: 10/27/1998
• Est. Priority Date: 01/27/1997
• Status: Expired due to Term

• Current Assignee: Femteck LLC
• Original Assignee: James C. Caillouette
• Inventors: Caillouette, James C.
• Primary Examiner(s): HINDENBURG, MAX F
• Application Number:
  US08/789,484
• Time in Patent Office: 638 Days
• Field of Search: 600/573, 600/584, 600/562, 600/569, 600/572
• US Class Current: 600/584
• CPC Class Codes: A61B 10/02 Instruments for taking cell samples or for biopsy A61B10/0038 and A61B10/0045 take precedence; needle locating or guiding means A61B17/3403; samplers for enzymology or microbiology C12M1/26; sampling or preparing biological specimens G01N33/48
• CPC Class Codes: A61B 2090/037 with a frangible part, e.g. by reduced diameter
• CPC Class Codes: G01N 31/221 for investigating pH value
• CPC Class Codes: G01N 33/84 involving inorganic compounds or pH

Abstract

In the method of detecting pathogenic bacteria in the vagina, the steps that include providing an elongated assembly including an elongated carrier and a flexible outer container supported on the carrier; providing a vaginal moisture absorbing or porous material swab at one end of the assembly to communicate with the interior of the outer container; providing a frangible inner container protectively located within the outer container, and providing a flowable aqueous alkaline fluid reactant within the inner container, bending or exerting pressure on the outer container sufficient to rupture the inner container; thereby releasing reactant into the interior of the outer container to enable reactant fluid flow to the swab or porous material, for reaction with bacteria containing vaginal moisture absorbed into the swab or porous material, whereby a gaseous product of the reaction may be detected, by characteristic odor. The outer container may be defined in whole or in part by the porous material which may be woven.

Claims

1. In the method of detecting pathogenic bacteria in the vagina, the steps that include

a) providing an elongated assembly including an elongated carrier and a flexible outer container supported on the carrier,

b) providing a vaginal moisture absorbing swab at one end of the assembly to communicate with the interior of said outer container,

c) providing a frangible inner container protectively located within the outer container, and providing a flowable aqueous alkaline fluid reactant within the inner container,

d) exerting pressure on the outer container sufficient to rupture the inner container, thereby releasing said reactant into the interior of the outer container to enable reactant fluid flow to said swab, for reaction with bacteria containing vaginal moisture absorbed into the swab,

e) whereby a gaseous product of said reaction may be detected, by characteristic odor.

2. The method of claim 1 wherein said aqueous alkaline fluid reactant consists essentially of a dilute aqueous solution of potassium hydroxide.

3. The method of claim 2 wherein said solution consists of 10 to 20% potassium hydroxide.

4. The method of claim 1 wherein said outer container is provided in relatively close association with said swab.

5. The method of claim 1 wherein said outer container is provided at a location on the carrier that is relatively remote from the swab.

6. The method of claim 5 including providing a duct associated with the carrier to convey fluid reactant from the container interior to the swab.

7. The method of claim 1 wherein said pressure is exerted manually.

8. The method of claim 1 including manipulating said assembly to cause the outer container to exert endwise and sidewise force on the swab to cause the swab to absorb vaginal moisture, in the vagina.

9. The method of claim 1 also including providing a pH detection means for detection of vaginal moisture pH in conjunction with performing the steps of claim 1.

10. The method of claim 9 wherein said pH detection means is provided at a location on the carrier.

11. The method of claim 9 including locating said pH detection means on the carrier, relatively remotely from said swab.

12. The method of claim 9 including providing an auxiliary carrier, and locating said pH detection means on the auxiliary carrier.

13. The method of claim 7 including controlling said manual pressure to control reactant fluid flow to the swab.

31. The method of claim 24 also including providing a pH detection means for detection of vaginal moisture pH in conjunction with performing the steps of claim 1.

14. In apparatus for detecting pathogenic bacteria in the vagina, the combination that includes:

a) an elongated assembly including an elongated carrier and a flexible outer container supported on the carrier,

b) a vaginal moisture absorbing swab at one end of the assembly to communicate with the interior of said outer container,

c) a frangible inner container protectively located within the outer container, and a flowable aqueous alkaline fluid reactant within the inner container,

d) whereby pressure exerted on the outer container sufficient to rupture the inner container thereby releases said reactant into the interior of the outer container to enable reactant fluid flow to said swab, for reaction with bacteria containing vaginal moisture absorbed into the swab,

e) and whereby a gaseous product of said reaction may be detected, by characteristic odor.

15. The combination of claim 14 wherein said aqueous alkaline fluid reactant consists essentially of a dilute aqueous solution of potassium hydroxide.

16. The combination of claim 15 wherein said solution consists of 10 to 20% potassium hydroxide.

17. The combination of claim 14 wherein said outer container is located in relatively close association with said swab.

18. The combination of claim 14 wherein said outer container is located at a position on the carrier that is relatively remote from the swab.

19. The combination of claim 18 including a duct associated with the carrier to convey fluid reactant from the container interior to the swab.

20. The combination of claim 14 wherein said carrier is elongated for manipulating said assembly to cause the outer container to exert endwise and sidewise force on the swab to cause the swab to absorb vaginal moisture, in the vagina.

21. The combination of claim 14 also including a pH detection means on the assembly for detection of vaginal moisture pH, thereby to detect abnormal or pathogenic bacteria, or estrogen level.

22. The combination of claim 21 wherein said pH detection means is located on the carrier, relatively remotely from said swab.

23. The combination of claim 21 including an auxiliary carrier, said pH detection means located on the auxiliary carrier.

24. In the method of detecting pathogenic bacteria in the vagina, the steps that include

a) providing an elongated assembly including an elongated carrier and a flexible outer container supported on the carrier,

b) said outer container having porous means associated therewith, to communicate with the interior of the outer container,

c) providing a frangible inner container protectively located within the outer container, and providing a flowable aqueous alkaline fluid reactant within the inner container,

d) exerting pressure on the outer container sufficient to rupture the inner container, thereby releasing said reactant into the interior of the outer container to enable reactant fluid absorption into the interior of the outer container to enable reactant fluid flow to said porous means with bacteria containing vaginal moisture absorbed into the porous means,

e) whereby a gaseous product of said reaction may be detected, by characteristic odor.

25. The method of claim 24 wherein said porous means is defined by the outer container.

26. The method of claim 24 wherein said porous means is defined by woven material.

27. The method of claim 25 wherein said porous means is defined by woven material.

28. The method of claim 24 wherein said aqueous alkaline fluid reactant consists essentially of a dilute aqueous solution of potassium hydroxide.

29. The method of claim 28 wherein said solution consists of 10 to 20% potassium hydroxide.

30. The method of claim 24 including manipulating said assembly to cause the outer container to exert endwise and sidewise force on the swab to cause the swab to absorb vaginal moisture, in the vagina.

32. In the method of detecting a substance in vaginal moisture, the steps that include

a) providing an elongated assembly including an elongated carrier and a flexible outer container supported on the carrier,

b) providing porous means to communicate with the interior of the outer container,

c) providing a frangible inner container protectively located within the outer container, and providing a flowable fluid reactant within the inner container,

d) said porous means adapted to absorb vaginal moisture containing substance to be detected,

e) exerting pressure on the outer container sufficient to rupture the inner container, thereby releasing said reactant into the interior of the outer container to enable reactant fluid access to said porous means to react with said substance enabling detection of said substance.

33. The method of claim 32 including also employing said assembly to detect estrogen level.

34. The method of claim 32 wherein said fluid reactant has a distinguishing color, visible when the reactant flows to said porous means.

35. The method of claim 34 including a dye provided in said fluid reactant, causing said reactant to exhibit said color.

36. The method of claim 35 wherein said dye is selected form the following group:

Methylene Blue

Indigo Carmine.