WO1994002819B1 - Apparatus and method for testing condoms as barriers to virus penetration - Google Patents

Apparatus and method for testing condoms as barriers to virus penetration

Info

Publication number
WO1994002819B1
WO1994002819B1 PCT/US1993/006705 US9306705W WO9402819B1 WO 1994002819 B1 WO1994002819 B1 WO 1994002819B1 US 9306705 W US9306705 W US 9306705W WO 9402819 B1 WO9402819 B1 WO 9402819B1
Authority
WO
WIPO (PCT)
Prior art keywords
condom
conduit
pressurizing
container
viral particles
Prior art date
Application number
PCT/US1993/006705
Other languages
French (fr)
Other versions
WO1994002819A1 (en
Filing date
Publication date
Priority claimed from US07/915,581 external-priority patent/US5422240A/en
Application filed filed Critical
Priority to AU47748/93A priority Critical patent/AU4774893A/en
Publication of WO1994002819A1 publication Critical patent/WO1994002819A1/en
Publication of WO1994002819B1 publication Critical patent/WO1994002819B1/en

Links

Abstract

A method for testing a condom for viral penetration includes the steps of positioning a condom to be tested in a restraining means so that expansion of the condom is restricted to a size corresponding to the mean anthropomorphic dimensions of a penis; pressurizing the condom via a liquid containing viral particles in suspension, and monitoring for passage of viral particles through the condom. The method which simulates conditions of human sexual intercourse while using a viral particle to test condom integrity can be effected using an apparatus with elements that are commonly found in a microbiology lab. The apparatus includes a conduit over which the open end of the condom to be tested is secured; a restrainer for restricting the expansion of the condom to a size corresponding to the mean anthropomorphic dimensions of a penis; a liquid containing viral particles in suspension, the liquid filling the condom; a pressurizing device for pressurizing the condom via the liquid; and a container filled with a collecting fluid wherein the condom and the restrainer are positioned so that the viral particles that have passed through the condom can be monitored.

Claims

_ 1g _
AMENDED CLAIMS
[received by the International Bureau on 25 January 1994 (25.01.94); original claims 8, 9, 18, 19, 21, 23 and 32-34 amended; new claims 35-40 added; remaining claims unchanged (6 pages)]
6. The apparatus of claim 1, further comprising means for circulating said collection fluid.
7. The apparatus of claim 1, wherein said conduit comprises a Buchner funnel .
8. The apparatus of claim 1, wherein said means for securing comprises at least one rubber band.
9. The apparatus of claim 1, wherein said restraining means comprises an open weave fabric.
10. The apparatus of claim 9, wherein said open fabric comprises organdy fabric.
11. The apparatus of claim 9, wherein said open fabric comprises nylon fabric.
12. The apparatus of claim 2, wherein said second means for securing comprises at least one rubber band.
13. The apparatus of claim 3, wherein said leakage indicator comprises a piece of pH paper.
14. The apparatus of claim 4, wherein said means for protecting is parafilm, wax paper, or plastic kitchen wrap.
15. The apparatus of claim 1, wherein said liquid containing said viral particles comprises a sterile Dulbecco's phosphate buffered saline.
16. The apparatus of claim 1, wherein said viral particles comprise a 0X174 bacteriophage.
17. The apparatus of claim 1, wherein said viral particles are a PRD1, MS2, T7, or 06 bacteriophage.
18. The apparatus of claim 1, wherein said conduit includes a second end, said means for pressurizing comprises a piece of tubing and a funnel, and wherein one end of said tubing is connected to said second end of said conduit and the other end of said tubing is connected to said funnel.
19. The apparatus of claim 1, wherein said means for pressurizing includes means for pressurizing said liquid containing viral particles in suspension to about 60 mm Hg.
20. The apparatus of claim 1, wherein said container comprises a fleaker having its top restriction removed.
21.- The apparatus of claim 5, wherein said means for positioning comprises a clamp and a ringstand. 22. The apparatus of claim 1, wherein said collection fluid comprises a sterile Dulbecco's phosphate buffered saline.
23. The apparatus of claim 6, wherein said means for circulating comprises a magnetic stirring bar having a sterilizable plastic coating.
24. An apparatus for testing viral penetration through a condom having an open end, comprising:
(A) a conduit having a first end, said open end of said condom being placed over said first end of said conduit;
(B) means for securing said open end of said condom over said first end;
(C) restraining means for restricting hydrostatic expansion of said condom to a size corresponding to mean anthropomorphic dimensions of a penis, said restraining means having an open end and being virally penetrable and virally inert, wherein said restraining means is positioned relative to said condom such that said restraining means envelopes a portion of said condom ;
(D) a liquid containing viral particles in suspension, said liquid filling said condom;
(E) means for pressurizing said liquid;
(F) a container capable of holding liquid, wherein said condom and said restraining means are positioned in said container; and
(G) a collection fluid in said container for collecting said viral particles that have passed through said condom.
25. A method for testing a condom for viral penetration, comprising the steps of : positioning a condom in a restraining means for restricting hydrostatic expansion of said condom to a size corresponding to mean anthropomorphic dimensions of a penis; pressurizing said condom by introducing thereinto a liquid that contains viral particles in suspension; and monitoring for passage of any viral particles through said condom.
26. The method of claim 25, wherein the positioning step comprises the step of positioning said condom and said restraining means in a container filled with a collection fluid. 27. The method of claim 26, wherein the monitoring step comprises the step of monitoring for any viral particles at about 30 minutes after said pressurizing step.
28. The method of claim 25, further comprising the step of rinsing lubricant from said condom and drying said condom before performing the positioning step.
29. The method of claim 25, wherein the pressurizing step comprises the step of pressurizing said condom to a pressure of about 60 mm Hg.
30. The method of claim 26, further comprising the step of assaying said collection fluid before performing the positioning step to assure that none of said viral particles are present in said collection fluid.
31. The method of claim 27, wherein the monitoring step includes the steps of stirring said collection fluid and then assaying said collection fluid.
32. An apparatus in the form of a kit for testing a condom having an open end for viral penetrability, comprising:
(A) a conduit having first and second ends, said first end of said conduit for receiving said open end of said condom;
(B) means for securing said open end of said condom over said first end;
(C) restraining means for restricting hydrostatic expansion of said condom to a size corresponding to mean anthropomorphic dimensions of a penis, said restraining means having an open end and being virally penetrable and virally inert;
(D) at least one viral particle;
(E) a first dried buffer powder for mixing with water and for suspending therein said at least one viral particle to form a liquid;
(F) a container capable of holding liquid, wherein said condom and said restraining means are to be positioned in said container; and
(G) a second dried buffer powder for mixing with water to form a collection fluid for collecting said viral particles that have passed through said condom. 33. The apparatus of claim 32, further comprising: second means for securing said open end of said restraining means over said first end of said conduit; a leakage indicator to be placed between said first end of said conduit and said open end of said condom nearer to said open end of said condom than said securing means; means for protecting said open end of said condom, said protecting means to be placed between said open end of said condom and said means for securing; means for positioning said conduit so that said condom and said restraining means will be positioned in said container; and means for pressurizing said liquid, wherein said pressurizing means is to be connected to said second end of said conduit.
34. The apparatus of claim 33, wherein said conduit comprises a Buchner funnel; said means for securing comprises at least one rubber band; said restraining means for restricting comprises an open weave fabric; said second means for securing comprises at least one rubber band; said leakage indicator comprises a piece of pH paper; said means for protecting is parafilm, wax paper, or plastic kitchen wrap; said first dried buffer powder comprises a sterile Dulbecco's phosphate buffered saline powder; said at least one viral particle is a X174, PRDl, MS2, T7, or φ6 bacteriophage; said means for pressurizing comprises a piece of tubing and a funnel, one end of said tubing is to be connected to said second end of said conduit and the other end of said tubing is to be connected to said funnel; said container comprises a fleaker having its top restriction removed; said means for positioning comprises a clamp and a ringstand; and said second dried buffer powder comprises a sterile Dulbecco's phosphate buffered saline powder. 35. The apparatus of claim 1, wherein the conduit, the means for pressurizing, and the container are made from a material which is heat sterilizable.
36. The apparatus of claim 35, wherein the conduit is made from one of glass, ceramic or plastic; the means for pressurizing is made from plastic; and the container is made from one of glass, polypropylene, or polycarbonate.
37. The apparatus of claim 24, wherein the conduit, the means for pressurizing, and the container are made from a material which is heat sterilizable.
38. The apparatus of claim 37, wherein the conduit is made from one of glass, ceramic or plastic; the means for pressurizing is made from plastic; and the container is made from one of glass, polypropylene, or polycarbonate.
39. The apparatus of claim 32, wherein the conduit and the container are made from a material which is heat sterilizeable.
40. The apparatus of claim 39, wherein the conduit is made from one of glass, ceramic or plastic and wherein the container is made from one of glass, polypropylene, or polycarbonate.
PCT/US1993/006705 1992-07-20 1993-07-20 Apparatus and method for testing condoms as barriers to virus penetration WO1994002819A1 (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
AU47748/93A AU4774893A (en) 1992-07-20 1993-07-20 Apparatus and method for testing condoms as barriers to virus penetration

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US07/915,581 1992-07-20
US07/915,581 US5422240A (en) 1992-07-20 1992-07-20 Apparatus and method for testing condoms as barriers to virus penetration

Publications (2)

Publication Number Publication Date
WO1994002819A1 WO1994002819A1 (en) 1994-02-03
WO1994002819B1 true WO1994002819B1 (en) 1994-03-17

Family

ID=25435961

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US1993/006705 WO1994002819A1 (en) 1992-07-20 1993-07-20 Apparatus and method for testing condoms as barriers to virus penetration

Country Status (3)

Country Link
US (1) US5422240A (en)
AU (1) AU4774893A (en)
WO (1) WO1994002819A1 (en)

Families Citing this family (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5493899A (en) * 1994-05-23 1996-02-27 Donald Guthrie Foundation For Education And Research Method for testing integrity of elastomeric protective barriers
US5681742A (en) * 1995-09-26 1997-10-28 Louisville Laboratories, Inc. Biological specimen containment and incubation device
US5659130A (en) * 1996-04-03 1997-08-19 Industrual Technology Research Institute Simple device for testing chemical permeation
US6164122A (en) * 1999-04-21 2000-12-26 Carter-Wallace, Inc. System and method including multiple test chambers for automated testing for holes in prophylactic device
EP1254250B1 (en) 2000-01-26 2005-03-23 Loma Linda University Method for the evaluation of implantable materials
US6430989B1 (en) * 2000-12-29 2002-08-13 Kimberly-Clark Worldwide, Inc. Method and apparatus for evaluating swimwear for underwater leakage
US20050189368A1 (en) * 2003-12-04 2005-09-01 Osterberg Brian J. Combination beverage service item and condom holder
TWM318124U (en) * 2007-01-05 2007-09-01 Smart Ant Telecom Co Ltd Examining apparatus for dust-proof and waterproof capabilities
CN104792471A (en) * 2015-04-03 2015-07-22 天津市计划生育药具管理中心 Female condom pinhole detecting method
DE102015005833A1 (en) * 2015-05-07 2016-11-10 Sartorius Stedim Biotech Gmbh Method and device for an integrity test of a test container

Family Cites Families (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
SU1295249A2 (en) * 1985-09-02 1987-03-07 Войсковая часть 13991 Method of checking leak-proofness of articles
US4843014A (en) * 1987-12-02 1989-06-27 Cukier Daniel S Apparel having a breach indicator
US5073482A (en) * 1988-06-21 1991-12-17 Epitope, Inc. Elastic barrier permeability testing device and method of use
JP2765881B2 (en) * 1988-11-09 1998-06-18 三菱電機株式会社 Intake air amount measurement device for internal combustion engine
US5138871A (en) * 1990-04-06 1992-08-18 The United States Of America As Represented By The Department Of Health And Human Services Method and apparatus for testing the permeability of prophylactics

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