Surgery – Diagnostic testing – Sampling nonliquid body material
Reexamination Certificate
2001-07-31
2004-03-09
Marmor, Charles (Department: 3736)
Surgery
Diagnostic testing
Sampling nonliquid body material
C600S570000, C604S001000, C604S330000
Reexamination Certificate
active
06702759
ABSTRACT:
BACKGROUND
The disclosures herein relate generally to a Pap test device and more particularly to a cervical specimen self-sampling device.
The Pap test (sometimes called a Pap smear) is a way to examine cells collected from the cervix and vagina. This test can show the presence of infection, inflammation, abnormal cells, or cancer.
A Pap test is an important part of a woman's routine health care because it can detect abnormalities that may lead to invasive cancer. These abnormalities can be treated before cancer develops. Most invasive cancers of the cervix are preventable if women have Pap tests and pelvic exams regularly. Also, as with many types of cancer, cancer of the cervix is more likely to be treated successfully if it is detected early.
A woman should have this test when she is not menstruating; the best time is between 10 and 20 days after the first day of the menstrual period. For about 2 days before a Pap test, she should avoid douching, or using vaginal medicines or spermicidal foams, creams, or jellies (except as directed by a physician). These may wash away or hide abnormal cells.
A Pap test is simple, quick, and painless; it can be done in a doctor's office, a clinic, or a hospital. While a woman lies on an exam table, the clinician inserts a speculum into her vagina to open it. To do the test, a sample of cells is taken from in and around the cervix with a wooden scraper or a small cervical brush or broom. The specimen (or smear) is placed on a glass slide or rinsed in liquid fixative and sent to a laboratory for examination.
A physician may simply describe Pap test results to a patient as “abnormal.” Cells on the surface of the cervix sometimes appear abnormal but are not cancerous. It is important to remember that abnormal conditions do not always become cancerous, and some conditions are more of a threat than others. A woman may want to ask her doctor for specific information about her Pap test result and what the result means.
When the test was first devised by George Papanicolaou, M.D., it was considered to be a test of vaginal pool cells to possibly detect uterine cancer. Fortuitously, it better detected cervical cancer. Ideally, a Pap test should capture squamous cells, which are cells from the transformation zone of the cervix. This zone is where the squamous cells and endocervical cells (including glandular cells) border upon one another. The transformation zone is where most cervical cancers originate.
There are countless women who do not obtain Pap tests every year as is recommended. This is because the test is unpleasant, painful, and for many women, it is embarrassing and/or humiliating. There are self-tests which have been developed and marketed. A benefit of the self-test is that some women who would otherwise not obtain a Pap test for the reasons given above, will be more likely to administer the self-test. However, some shortcomings of presently available self-tests are that they utilize a technology centered around fixing cells immediately in a glass slide and are designed to avoid so-called “contamination” of vaginal cells. These tests are cumbersome and produce slides that are sometimes inadequate due to an air drying artifact.
Therefore, what is needed is a self-administered Pap test which can provide a reliable sampling of cells for analysis. The present embodiments consider that vaginal pool cells are just as valuable as those obtained by the standard pap smear procedure; abnormal cells turnover much faster and slough off faster than normal cells. By testing cells in the vaginal pool, one can determine just as accurately when an abnormality exists. It is believed that each of these cell types slough off and enter the pool of vaginal fluids, which occurs through natural body fluid movement.
SUMMARY
One embodiment, accordingly, provides an intra-vaginal self-administered cell collecting device. To this end, the device includes a tampon like telescoping tube containing an expandable preformed absorbent member. A textured cover is provided on the absorbent member for capturing sloughed-off cells residing in vaginal fluids and for substantially retaining the perform of the absorbent material from expansion after exposure to the vaginal fluids.
The principal advantages of this embodiment are that a large number of cells are captured for analysis; there is a lack of the avoidance factor of desired vaginal cells; and the self-administered cell collecting device is convenient and easy to use.
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Haynes & Boone LLP
Marmor Charles
Private Concepts, Inc.
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