Surgery – Diagnostic testing – Sampling nonliquid body material
Reexamination Certificate
1999-04-23
2002-02-12
Winakur, Eric F. (Department: 3736)
Surgery
Diagnostic testing
Sampling nonliquid body material
C600S570000, C600S572000
Reexamination Certificate
active
06346086
ABSTRACT:
TECHNICAL FIELD
This invention relates generally to medical devices, and more particularly to a device for collecting cells at least from around the outer opening of the cervix of a human or veterinary patient, and preferably for collecting both cells from the lining within the cervix and cells around the outer opening of the cervix of a human or veterinary patient.
BACKGROUND OF THE INVENTION
It has become virtually axiomatic that the best time to treat diseases such as cancer is when they are in their earliest phases. By necessity, the early treatment of cancer requires that it be detected early. A variety of known techniques for detecting cervical cancer entails the scraping or sampling of tissue from the uterine or endocervical canal, and from around the outer opening of the uterus (the cervical os). Tissues so obtained can be subjected to cytopathic or other examinations, perhaps the most common method of examination being the Pap (Papanicolaou) smear.
The known devices for exfoliating and collecting exocervical and endocervical tissue vary widely in complexity and utility. The most simple is a cotton swab introduced into the uterine canal. Wet spatulas have also been used to sample the exocervix and the uterine canal. Tissue samples have been aspirated through plastic or glass pipettes. Full dilation and curettage of the uterine canal has been employed, as have microcurettes. Brushes have been adapted to either exfoliate or collect endometrial tissue, but generally these have not been adapted to adequately perform both functions simultaneously. Generally, when the brush bristles are of a suitable length or stiff enough to exfoliate tissue well, they collect the exfoliated tissue poorly; and when the bristles are of a suitable length or flexible enough to collect tissue well, they fail to exfoliate sufficient tissue, or a sufficiently uniform sample of tissue.
One exception is the uterine endometrial tissue sample brush disclosed in U.S. Pat. No. 5,713,369 (Liang-Che Tao and John A. Maksem, Feb. 3, 1998). That brush, sold by COOK OB/GYN®, simultaneously performs both of these functions quite well, and includes a generally cylindrical arrangement of bristles. Another brush incorporating a generally cylindrical arrangement of bristles is sold by COOK OB/GYN® under the name DETECT® Cytology Brush. This brush includes a polystyrene handle which carries the bristles on it, and which is scored to permit a portion of the handle carrying the bristles to be snapped off and used in conjunction with popular STD (sexually transmitted disease) test kits. The use of each of these brushes is intentionally limited to endocervical sampling, however, and these brushes are not intended to additionally sample exocervical tissues.
A diagnostic device for obtaining cytological samples from both the exocervix and the endocervix is disclosed in U.S. Pat. No. 3,626,470 (H. J. Antonides et al., Dec. 7, 1971). The device of that patent comprises an elongated handle which carries on it a foamed or spongelike pledget molded on a platform member. The pledget is impregnated with a critical amount of a proteolytic enzyme which acts upon mucus encountered at or retrieved from sites of cellular sampling, thereby avoiding interference with the subsequent analysis of the collected materials. The pledget includes a nose portion surrounding a stem extending upwardly from the platform member. The pledget preferably comprises a silastic RTV (room temperature vulcanizing) foam, for example, a mixture of dimethyl polysiloxane fluid polymers and inert diatomaceous earth fillers. Silicone rubbers, polyurethanes and polyether urethanes and the like are also asserted to be useful. The pore size for a foamed silicone rubber ranges from 130 to 546 microns; more particularly, the mean and standard deviation are about 336.2 ±98.5 microns. The apparent specific gravity is in the range of from 0.177 to 0.292, and more particularly, a mean value and standard deviation of 0.223±0.028. Unfortunately, the disclosed variety of composition, pore size and specific gravity may not yield the best collection of cells, considering in combination the pliability of the foam (that is, the ability of the foam to take the shape of the internal and external surfaces of the cervix during sampling), the relative abrasiveness of the foam (increasing the number of cells which are scraped from the cervix) and whether the foam is open or closed cell (the former enhancing the retention and/or collection of the abraded cells).
U.S. Pat. No. 4,754,764 (I. D. Bayne, Jul. 5, 1988) similarly discloses a cervical cytology device which can include a disc for collecting exocervical cells, carried on a hollow shaft in which is telescopically received an endocervical brush for collecting cells. The disc and brush are preferably bristled, although urethane and polyurethane are suggested as materials for collecting cells. No specific physical arrangement of such other materials is disclosed, however.
The other conventional devices and techniques for sampling uterine endometrial tissue mentioned above have suffered their own drawbacks. Some sampling instrument diameters are uncomfortably large when inserted into the uterine canal, and their use can be sufficiently painful to the patient to require a general anesthetic. Some devices have undesirably low rates of successful insertion, while the use of others leads to unacceptably high rates of complications. Some devices have relatively poor yields (that is, inadequate sample sizes) when compared to conventional dilation and curettage. Full dilation and curettage, of course, entails its own trauma and disadvantages, including the infliction of open wounds requiring further post-procedural treatment. Many devices fail to obtain a large enough sample of tissue to ensure that localized abnormalities are detected.
It would be highly desirable to have a device which safely collects both exocervical and endocervical cells in relatively good patient comfort. It would also be highly desirable to have such a device which was simpler in construction than prior devices, and which did not include a relatively large plurality of individual bristles. It would further be desirable to have such a device in which the collecting portion or portions were sufficiently pliable to take on the shape of both the internal and external cervical surfaces being sampled. It would also be desirable to have such a device which was further adapted for use with other surgical devices, for example, for use with endoscopes, optic fibers, sensors, guide wires and other endocervical sample brushes.
SUMMARY OF THE INVENTION
The foregoing problems are solved and a technical advance is achieved in an illustrative medical device particularly adapted for abrading and collecting an acceptably large number of cells from at least the external surface of the cervix, and preferably from both the internal and external surfaces of the cervix. In one principal embodiment, the device of the present invention differs from prior devices for sampling cervical cells in that it employs a pair of foam portions each particularly suited for adequately sampling a different cervical surface.
More particularly, in this embodiment, the device of the present invention includes an elongate foam portion for sampling cells from the internal surface of the cervix, and a disk-like foam portion for sampling cells from the external surface of the cervix. The elongate foam portion and the disk-like foam portion can be carried on opposite ends of an elongate handle, or can be unitarily formed as a single foam portion carried by an end of the elongate handle. In either case, the elongate foam portion and the disk-like foam portion comprise an open cell, reticulated foam, preferably a foam as described in more detail below. The use of an open cell, reticulated foam permits the device of the present invention to enjoy superior sampling over prior cervical cell sampling devices, whether sampling only exocervical cells, or sampling both endocervical and exocervical cells.
Bosley, Jr. Rodney W.
Maksem John A.
Sips Kathren J.
Cook Urological Inc.
Godlewski Richard J.
Hunt James B.
Marmor II Charles
Winakur Eric F.
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