Surgery – Diagnostic testing – Sampling nonliquid body material
Reexamination Certificate
2000-02-24
2001-10-16
Nasser, Robert L. (Department: 3736)
Surgery
Diagnostic testing
Sampling nonliquid body material
Reexamination Certificate
active
06302853
ABSTRACT:
FIELD OF INVENTION
The present invention relates to an improved apparatus and system for obtaining a sample of cervical tissue and/or vaginal secretions such that developing cancerous cells may be detected. The present invention also relates to an improved method of using the sampling apparatus to collect such samples.
BACKGROUND
Unlike many cancers that cause pain, noticeable lumps, or other early symptoms, cervical cancer has no telltale warning signs until it is so advanced that it is usually unresponsive to treatment. Only in the late stages does cervical cancer cause pain in the lower abdominal or back region, or produce other noticeable symptoms. Tests which provide early detection of cervical, uterine and vaginal cancer are paramount to the effective treatment and recovery film the disease. A Papanicolaou smear test, commonly referred to as a Pap test, has long been established as a highly usefull diagnostic tool which allows the identification of premalignant and malignant tissue at very early stages of the disease, as well as the identification of various inflamations and infections. The American Society of Clinical Pathologists recommends women have an annual Pap test.
A Pap test is a clinical procedure in which typically a bivalve speculum is inserted into a vaginal cavity and the cervix is exposed for sampling. A sample smear of cervical or vaginal secretions is then removed using an inserted scraper, probe, brush or similar type of device. The collected smear is evenly spread on one or more glass slides for microscopic examination. These standard-sized laboratory slides may be lined with hundreds of thousand of cervical cells. These slides are examined for the early detection of cancer or to determine the presence of certain hormonal conditions or certain infections. Lurking in these cells may be as few as a dozen abnormal cells. Finding such telltale cells is akin to finding a needle in a haystack, especially at the end of the day when laboratory technicians are likely to have examined countless Pap test slides. Therefore, the better the sampling, the better the chance of detecting an abnormal cell. In addition, abnormalities in cell shape may be slight and difficult for even the trained eye to detect, or may be masked by infection.
At one time Pap tests were performed almost exclusively by medical professionals in a doctor's office or a hospital. Many women, however, did not receive their yearly test because of their inability to visit a doctor on an annual basis, their reluctance to see a doctor or the expense of visiting a doctor coupled with test costs. As a result, self-administered sample collecting kits or system were developed so that women who did not go to the doctor on an annual basis could still be tested for abnormal cells. However, conventional self-administered sample collecting systems may not collect a sufficient amount of cervical tissue sample, or they may cause great discomfort to the user during use.
One such self-administered Pap test sampling collecting system is disclosed in U.S. Pat. No. 5,787,891 to Sak, that is herein incorporated by reference. This system includes a tubular speculum for inserting into the vaginal cavity, a guide sleeve located within the tubular speculum, and a swab assembly removably disposed within the guide sleeve. The swab assembly includes a sample collecting swab positioned within a swab sleeve in a retracted position when the device is first inserted into the vaginal cavity. A stem is then used for pushing the sample collecting swab out of the swab sleeve to an extended position and into contact with the cervical tissue. The sample collecting swab absorbs cervical samples until the user decides that enough sampling has been done.
Some patients may have difficulty using a self-administered sample collecting system because of the construction of its vaginal speculum. The speculum may be difficult or uncomfortable to insert into the vaginal cavity of the patient. The speculum may require the patient to use excessive force to push the speculum towards her cervix, thereby possibly causing an internal injury. Thus, the vaginal speculum may discourage women from taking the Pap test. Also, these self-administered sample collecting systems may not provide the user with the ability to determine the depth to which the vaginal speculum and the sampling device have been inserted into a vaginal cavity. The lack of proper insertion can lead to poor cervical samples and unreliable results.
Another problem that exists with conventional self-administered sample collecting systems for Pap tests is the inability of the patient to determine when a sufficient amount of sample has been obtained. These sampling systems do not effectively assist the patient in determining when the sampling device has been moved enough within the vaginal cavity to obtain an adequate amount of sample. Insufficient sampling may give inaccurate test results, increase costs and discourage a woman from receiving future testing at the recommended frequency.
Previous self-administered sample collecting systems require the patient to place the collected sample on medical examination slides. This procedure can produce an unsatisfactory specimen including bodily fluids that can impede the proper diagnosis of the smear. As a result, the patient will be forced to repeat the procedure in order to obtain another sample.
Thus, there is a need for an improved cervical sampling apparatus that can be effectively used by a woman performing sampling on herself. Further there is a need for an improved method of cervical sampling and a portable sampling system to advantageously provide for the detection of cancer.
It is an object of the present invention to overcome the aforementioned drawbacks in the conventional self-administered sample collecting systems for Pap tests.
An object of the present invention is to overcome the prior art problems of comfortably and effectively inserting a tubular speculum device into a vaginal cavity.
Another object of the present invention is to allow patients to readily determine when a sample collecting device has been rotated through a complete revolution so that the patient can keep an accurate count of how many times she has rotated the sample collecting device in order to achieve better sampling.
SUMMARY OF THE INVENTION
In view of the foregoing, the present invention is directed to an improved system for collecting samples of cervical tissue and/or vaginal secretions. In addition, the present invention is directed to an improved method of using the sample collecting system for a Pap test.
The present invention includes a cervical sampling apparatus that has a vaginal insertion tube, an introduction guide member that is removably positioned inside the vaginal insertion tube and a cervical sampler that can be inserted within the vaginal insertion tube after the introduction guide member has been removed. The cervical sampler can be slid and rotated relative to the vaginal insertion tube when positioned therein. The cervical sampler includes a sample collecting member for obtaining a cervical sample.
The present invention further includes a cervical sampling system that comprises a sampling system enclosure housing the cervical sampling apparatus and a cervical sample collection contains. The sample collection container is used to send the collected samples to a lab for testing.
The cervical sampling apparatus according to the present invention can also include the vaginal insertion tube having a signaling member and the cervical sampler including the sample collecting member, a handle, and an elongated body that extends along a longitudinal axis between the sample collecting member and the handle. The signaling member of the vaginal insertion tube cooperates with a signaling member of the cervical sampler to provide an audible or tactile signal to the user when the cervical sampler has been rotated past a reference point, thereby indicating that the cervical sampler has been rotated through a complete revolution.
In yet another aspec
Banner & Witcoff , Ltd.
Nasser Robert L.
R & G Medical And Development Corp.
Wingood Pamela L.
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