Surgery – Diagnostic testing – Sampling nonliquid body material
Reexamination Certificate
2000-06-26
2002-03-05
Lacyk, John P. (Department: 3736)
Surgery
Diagnostic testing
Sampling nonliquid body material
C600S569000, C604S001000
Reexamination Certificate
active
06352513
ABSTRACT:
TECHNICAL FIELD
The invention relates generally to cervical cell sampling and more specifically to devices and methods whereby cervical cell samples can be personally collected by a patient. The invention relates to devices and methods in which the cervical cell samples are collected by the patient and then forwarded to a physician or lab for analysis.
BACKGROUND
Cervical cancer is a leading form of cancer among women. In the United States alone, there are believed to be more than two million cases of precancerous cervical abnormalities annually. The U.S. also sees, on average, about sixty five thousand cases of cervical carcinoma and about sixteen thousand cases of invasive cervical cancer. Although screening is less common outside the Unites States, nearly half a million cases of cervical cancer are detected each year around the world.
Cervical cancer frequently begins as a precancerous lesion of the cervix. These lesions are also known as cervical intraepithelial neoplasia. If left untreated, these lesions can deepen over time and ultimately develop into an invasive cancer of the cervix and associated tissues. Fortunately, early detection followed by appropriate treatment results in a very high cure rate for cervical cancer.
Therefore, it is quite important that at least certain factions of the female population undergo regular screening. These factions include patients with previous cervical abnormalities and those who have a family history of cervical abnormalities. Women who are sexually active are at greater risk and should undergo regular screening, as are those who test positive for HPV (human papillomavirus). This is a sexually transmitted virus that in some forms can cause genital warts.
During the 1940's, Dr. George Papanicolaou developed a screening test which bears his name and which has become the most widely used screening technique for detecting abnormal cervical cells. Today, this test is known more commonly as the PAP test or the PAP smear test. Typically, the PAP test is performed in the physician's office as part of a woman's routine gynecological examination. The test involves collecting cervical cells via a brush, stick or swab that is used to loosen and then collect cells that can be examined microscopically.
Typically, the PAP test is performed by inserting a speculum into the patient's vagina to expose the cervix. The surface of the cervix is then scraped by a brush, stick or swab and the exfoliated cells thereby collected are smeared upon a microscope slide for cytological examination. There are a number of drawbacks to the PAP test.
The PAP test is nearly always performed in a physician's office by a gynecologist or other medical professional. Thus, the test is not inexpensive, as the expense of an office visit is necessarily included. This means that the PAP test is not readily available to all women, for example, as would be desired in public health screening. Further, the test is considered by many women to be uncomfortable and embarrassing. Some women have religious beliefs that prohibit gynecological procedures such as the PAP test.
Although most medical professionals consider the PAP test something that should be done throughout the later stages of a woman's life, many women avoid the gynecologist once they are done bearing children. Thus, a need remains for an apparatus that will extend cervical screening to more women by permitting women to easily and comfortably obtain a cervical cell sample without requiring a physician's assistance. Such an apparatus could be used, for example, to augment traditional PAP tests by providing cervical cell screening to women who would otherwise not have a PAP test. A personal cervical cell collector could also be used to confirm a previous diagnosis.
SUMMARY OF THE INVENTION
Accordingly, the invention relates to a personal collector that can easily and comfortably be used by a woman in the privacy and comfort of her own home. Once the cervical sample is obtained, it can be forwarded to a physician's office or other lab location for analysis. If the subsequent analysis proves positive, the woman can then be seen by a physician.
The invention can be found in a cervical cell collection apparatus that is intended for personal use. The collection apparatus includes an outer guide assembly curved to approximate the natural curvature of a woman's vagina. An inner sampling assembly positioned within the outer guide assembly is also included. The inner sampling assembly includes a collector pad and is moveable from a first position in which the collector pad is located within the outer guide assembly to a second position in which the collector pad is located outside the outer guide assembly. The inner sampling assembly is configured to collect cervical cells while in the second position while the collector pad is protected against unwanted sample contamination while in the first position.
In another embodiment, the collection apparatus includes an outer guide assembly curved to approximate the natural curvature of a woman's vagina, wherein the outer guide assembly includes a protective tip. An inner sampling assembly positioned within the outer guide assembly is also included. The inner sampling assembly includes a flexible shaft bearing a collector pad at a first end and a gripping structure at a second end, and is moveable from a first position in which the collector pad is located within the outer guide assembly to a second position in which the collector pad is located outside the outer guide assembly. The inner sampling assembly is configured to collect cervical cells while in the second position while the collector pad is protected against unwanted sample contamination while in the first position.
The invention is also found in a personal cervical cell collection kit that includes a personal collector and a fixative canister. The personal collector is as described above, while the fixative canister includes an outer shell and an inner cap that fits within the outer shell but is configured to receive the protective tip of the personal collector. The fixative canister also includes a unit dose container that contains a volume of fixative and that has an easily piercable or frangible segment. An outer cap that is configured to cover an end of the outer shell is also included.
The invention is also found in a method of obtaining a cervical cell sample without requiring the assistance of medical personal. The method includes obtaining a kit having a personal collector and a fixative container, wherein the personal collector includes a sampling collector pad. The personal collector is inserted into the vagina until the personal collector contacts the cervix, at which point mucus is removed from the cervix. The sampling collector pad collects a cervical cell sample and is then withdrawn back into the personal collector, which is then withdrawn from the vagina. The sampling collector pad is inserted into the fixative container to preserve the cervical cell sample.
In another embodiment, the personal collector includes a protective tip that serves to remove mucus from the cervix prior to sampling, thereby yielding a cleaner sample that is less likely to contaminated.
Other features and advantages of the present invention will be apparent from the following detailed description and drawings.
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Anderson David M.
Domanik Richard A.
Gombrich Peter P.
Ampersand Medical Corporation
Lacyk John P.
Marmor II Charles
Merchant & Gould P.C.
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