Surgery – Truss – Pad
Patent
1982-02-18
1984-05-15
Recla, Henry J.
Surgery
Truss
Pad
128304, 128757, A61B 1000
Patent
active
044482051
DESCRIPTION:
BRIEF SUMMARY
The present invention relates to an instrument for clinical sampling of exfoliated cells from the cervix.
Cytological tests of cell samples are now quite extensive and have proved to be an exceptional means for diagnosing cell changes in the area around the portio-cervix and endocervical canal. Such tests are made in great number and it is not uncommon that entire age groups of women within a district are tested.
Cell samples from said area reveal cell changes with a reliability of about 95% and of the positive results, 20-25% are pre-cancerous. A positive result in this test usually results in an operation, e.g. a so-called scraping or use of a coned instrument. The result of such treatments is usually good and warrants extensive taking of samples from healthy women in certain age groups.
The samples are usually taken with a curette or similar instrument by scraping cells from the mouth of the cervix. The sample is smeared directly on a slide, is fixed and transported to a cytological laboratory. At the laboratory the sample is prepared for microscopic examination by suitable dyeing. Finally the dyed cell sample is examined under the microscope, and the presence of atypical cells is noted and reported. The work with microscopic examination is demanding and time-consuming. The total cost for a sample is 50-100 Swedish Kronor (1980).
Consequently intensive development work is in progress to make the work with cytological samples less expensive and simpler. In order to facilitate the work with the evaluation of samples under the microscope, several different systems are being developed for automatic evaluation of cells in cell samples as normal or atypical. Algorithms have been developed for automatic evaluation and even the development of commercial systems is fairly well along.
In order to evaluate cells automatically, it is very important that the samples contain a sufficient number of cells and that the cell sample actually be taken so that any cell changes are actually represented in sufficient amounts.
When taking clinical samples from the cervix, the person taking the sample usually insets a speculum into the vagina, and a curette is then inserted via the speculum to the cervix and is rotated in the mouth of the cervix. It is however difficult even for an experienced taker of samples to always get a representative sample. A number of different sampling instruments have been developed, among which we might mention the one described in U.S. Patent Specification No. 2 514 665.
According to this patent, an instrument is used with a conical body at its upper end provided with a cutting edge which scrapes or cuts off material from the cervix when the instrument is rotated in the cervical canal.
According to another U.S. Patent No. 2 839 051, a device is revealed which cuts tissue from the cervix with a razorblade edge, said device comprising a conical body designed to penetrate into the cervical canal and center said razorblade edge in relation to the cervix. The cone is provided with cutting teeth which cuts off tissue in the cervical canal.
U.S. Pat. No. 3 540 432 shows an instrument consisting of a rod with a conical end provided with ribs for sampling in the cervix. Somewhat surprisingly, the instrument is said to be capable of self-use. U.S. Pat. No. 3 881 464 shows an instrument for sampling in the cervix consisting of a brush made with a spirally turned wire. The brush appears to require very careful handling in order not to cause injury.
None of the previously known sampling instruments is suitable for large series of tests, in which even people with less extensive training will be able to take samples clinically and at the same time see to it that the sample taken is sufficiently representative for reliable automatic evaluation.
Even for experienced samplers it has proved difficult to insert the previously known sampling instruments into the cervical canal without causing injury. It is also known that cell changes can be situated at different points in the cervical canal. Table 12 in "Diagnostic Cy
REFERENCES:
patent: 2514665 (1950-07-01), Myller
patent: 3472230 (1969-10-01), Fogarty
patent: 3540432 (1970-11-01), Ayre
patent: 3796211 (1974-03-01), Kohl
patent: 3913564 (1975-11-01), Freshley
Fukushima Christine A.
Recla Henry J.
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