Surgery – Diagnostic testing – Sampling nonliquid body material
Reexamination Certificate
2000-11-21
2002-06-11
Shaver, Kevin (Department: 3736)
Surgery
Diagnostic testing
Sampling nonliquid body material
Reexamination Certificate
active
06402700
ABSTRACT:
STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT
Not Applicable.
BACKGROUND OF THE INVENTION
1. Field of the Invention
This invention relates to gynecological medical devices, and more particularly to a medical tool and method for enabling a woman to collect a personal cervical cell sample for use during a Papanicalou (PAP) test, commonly known as a PAP smear.
2. Description of Related Art Including Information Disclosed Under 37 CFR 1.97 and 1.98
The PAP smear is an important routine gynecological test usually done annually in sexually active females to screen for cervical cancer. The tests known in the art typically require an in office visit with a gynecologist where the doctor takes a sample of the cervix for lab analysis. Current medical practice requires a gynecologist to insert a speculum into the patient's vagina to access the cervix for tissue sample collection. Many women find this method an uncomfortable, intrusive exam, and opt to not have the routine screening performed.
While certain groups of women are recognized to be at a higher risk for cervical cancer and exposure to a variety of Human Papilloma Virus subtypes, many monogamous women do not fall into the high risk categories. For these women, the screening guidelines recommend testing every three years after two normal annual PAP smears. For many women, the routine screening test would be regularly performed if it could be done in a non-intrusive, private manner.
Of particular relevance to the instant invention is U.S. Pat. No. 5,121,752 to Canna. Canna '752 discloses a self-obtaining PAP smear apparatus which must be used by a woman in an upright position. The apparatus includes a rigid, cylindrical speculum, angled endocervical sampler and an elongated angled spatula. The cylindrical speculum includes an angled front orifice designed to fit about the cervix. After insertion, a mirror is used for visual observation to affirm correct placement of the orifice around the cervix. In actual practice, however, obtaining a clear view by speculum of the cervix is difficult even under direct vision. In addition, the length and rigidity of the speculum prevent the use of digital assistance to confirm proper placement.
Although the aforementioned reference discloses one method and apparatus for self-obtaining PAP smears, it fails to teach or disclose an efficient, easy to use method and apparatus that enables digital location of the cervix for accurate placement of the speculum and reliable sampling of the cervical tissue. The present invention meets these needs. The invention provides an efficient tool for privately performing a non-intrusive PAP smear without the need for assistance by a gynecologist or other medical practitioner.
BRIEF SUMMARY OF THE INVENTION
The present invention is a PAP smear apparatus and method of use for enabling a user to obtain a personal PAP smear. The apparatus of the invention includes a flexible speculum, an insertion handle, and a means for movably attaching the flexible speculum to the insertion handle. The flexible speculum includes a hollow ring housing a collapsed or compressed tube. The ring is split along its circumference defining two separate, adjacent halves. The tube is attached to the ring halves at its ends and includes a reinforcement mechanism to prevent the bore from collapsing when the tube is expanded during use.
In one embodiment, the tube's reinforcement mechanism is a coiled wire, which spirals circumferentially throughout the length of the tube.
In a preferred embodiment, the means for movably attaching the flexible speculum to the insertion handle is a ratchet mechanism wherein the ratchet catch is on the first ring half and the ratchet spur is proximal to the first end of the insertion handle.
In another aspect of the invention, a means for securing the first and second ring halves together until the user desires to expand the compressed tube is provided. In one aspect, the securing means is a latching mechanism such as a spring latch, hinge, or hook. In another aspect, the insertion handle holds the second ring half adjacent to the first ring half when the ring is in its horizontal insertion position.
It is another object of the invention to provide a method for enabling a user to obtain a cervical PAP smear without the aid of a gynecologist or other medical professional. The method includes the steps of inserting the flexible speculum into the user's vagina, positioning the speculum ring around the user's cervix and separating the ring halves. Separating the ring halves enables expansion of the compressed tube housed within the ring by drawing the free half back through the user's vagina. After the tube is expanded, the user may insert a sampling tool through the bore of the tube to wipe the cervix, the endocervical canal and surrounding surface areas to collect a cell or tissue sample. Once the sampling is completed using one or more sampling tools, the flexible speculum is removed from the user's vagina and discarded.
REFERENCES:
patent: 4620548 (1986-11-01), Hasselbrack
patent: 4628941 (1986-12-01), Kosasky
patent: 5121752 (1992-06-01), Camma
patent: 5605161 (1997-02-01), Cross
patent: 5769090 (1998-06-01), Brown
patent: 5795289 (1998-08-01), Wyttenbach
patent: 6096047 (2000-08-01), Smit
patent: 6155990 (2000-12-01), Fournier
Catlett Charlotte W.
Shaver Kevin
Wingood Pamela L
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