Surgery – Diagnostic testing – Sampling nonliquid body material
Reexamination Certificate
1999-12-27
2001-01-16
Winakur, Eric F. (Department: 3736)
Surgery
Diagnostic testing
Sampling nonliquid body material
Reexamination Certificate
active
06174293
ABSTRACT:
BACKGROUND OF THE INVENTION
This invention relates to medical diagnostic testing.
More particularly, it relates to the collection of vaginal fluids and exfoliated vaginal cells for diagnostic purposes.
Currently, the vast majority of clinical diagnostic testing of biological fluids utilize serum and urine. It is believed that the United States Food and Drug Administration has not approved a clinical diagnostic test which utilizes any biological fluid other than whole blood, serum, plasma, saliva or urine. Tears and sweat are other fluids being used for various non-FDA approved diagnostic purposes, although such uses have been very limited. These fluids are very different in composition and their uses in clinical medicine.
The use of gynecological tissue for cancer diagnostic purposes has been limited to the traditional PAP Test Cervical Scraping (PTCS method of collection) and the subsequent histological smears for cervical cancer screening. A chemical or immunochemical analysis of non-menstrual vaginal fluid, menstrual fluid and/or the cellular extracts of menstrual fluid for the purpose of disease detection or patient well-being have not been exploited by the general medical community.
There have been a number of articles written by Dr. Matthew Freund and others which suggest that one may collect a large quantity of cervical and endometrial cells from menstrual fluids rather than through the traditional PTCS method. Dr. Freund found that both ectocervical and other cells collected from the menstrual fluid flow are well preserved for standard laboratory cytological procedures. They are similar in appearance to cells collected by current clinical methods, and give similar reactions to chemicals and stains, and may be analyzed by the same procedures as cervical smears for PAP testing.
OBJECTS OF THE INVENTION
It is therefore one object of this invention to provide an improved method for collecting vaginal fluid and vaginal cells for diagnostic purposes.
It is another object of this invention to provide a non-invasive method for collecting vaginal fluid and vaginal cells for diagnostic purposes.
It is still another object of this invention to provide an over-the-counter kit for collecting vaginal fluid and vaginal cells for diagnostic purposes.
SUMMARY OF THE INVENTION
In accordance with one form of this invention, there is provided a method for collecting vaginal fluid and exfoliated vaginal cells in menstrual fluid for medical diagnostic purposes. An absorbent media is placed interlabially or intravaginally. Fluid is collected within the absorbent media. The absorbent media is removed, and the fluid is extracted therefrom. For intravaginal collection, the absorbent media may be placed in a housing having fluid receiving apertures prior to insertion into the vagina. Medical diagnostic testing is performed on the extracted fluid.
Preferably the absorbent media used to collect vaginal fluid is an interlabia pad, such as the pads described in U.S. Pat. Nos. 3,726,277; 3,983,873; and 4,196,562 issued to Hirschman and licensed to Athena Medical Corporation, assignee of the present invention, or the pad described in U.S. Pat. No. 4,995,150 issued to Gerstenberger et al and assigned to Athena Medical Corporation. The Hirschman and Gerstenberger et al patents hereby are incorporated herein by reference.
It is preferred that the absorbent media used to collect exfoliated vaginal cells from menstrual fluid be of a shape similar to a tampon, but of a different construction and composition. Preferably, the tampon shaped device includes an absorbent core which is at least partially surrounded by a porous matrix.
Over-the-counter kits may be provided so that the collection of the fluids may be done by the consumer in the privacy of her home.
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Buck Robert L.
Fleming William H.
A-Fem Medical Corporation
Klarquist Sparkman Campbell & Leigh & Whinston, LLP
Winakur Eric F.
Wingood Pamela
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