US 3540432 A
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United States Patent James E. Ayre 26 Fox Hollow Lane, Old Westbury, New York 11568 [211 App]. No. 694,214
 Filed Dec. 28, 1967  Patented Nov. 17, 1970 72] Inventor  JYTOLOGICAL INSTRUMENT 12 Claims, 3 Drawlng Figs.
'  Int.Cl. A61b 10/00  Field ofSearch... l28/2,2B, 231,276, 304, 232, 239-241 Cursory: 195/1nquired  References Cited UNITED STATES PATENTS 1,145,520 7/1915 Smith 128/239 2,047,437 7/1936 Sinkler 128/239 2,701,559 2/1955 Cooper 128/2 2,835,246 5/1958 Boettger 128/2 3,057,352 10/1962 McKenna.. 128/248 3,088,454 5/1963 Shute 128/2 3,163,160 12/1964 Cohen 128/2 3,234,945 2/1'966 Waldman et al 128/239X 3,368,549 2/1968 Barr et al. 128/2 3,388,043 6/1968 lngvorsen 128/2X 3,400,708 9/1968 Scheidt 128/2 3,438,366 4/1969 Kariher et al. 128/2 FOREIGN PATENTS 628,040 3/1936 Germany 128/231 1,031,641 6/1966 Great Britain.. 128/2 194,271 9/1967 U.S.S.R. 128/2 OTHER REFERENCES The Merck Index. Seventh Edition, 1960. pp. 489-490, (copy in GR 335) Primary'Examiner-Richard A. Gaudet Assistant Examiner- Kyle L. Howell Anorney- Kenyon & Kenyon, Reilly Carr & Chapin ABSTRACT: The head of the instrument is provided with scraping ribs for scraping cells from the cervix upon rotation as well as aspiration holes for suction of the desquamated cells into the head. A glycerine charge is placed on and within the head to attract and encase the cells in order to preserve the cells until ready for cytological study. The instrument is capable of self-use and of being mailed.
Patented Nov. 17, 1970 3,540,432
INVENTOR. (/AMES iewasr- Ayes (YTOLGICAI. INSTRUMENT This invention relates to a-cytological instrument. More par ticularly, thisinvention relates to a mailable cytological instrument. Still more particularly. this invention relates to a inailable cytological instrument for collecting cells from the cervix and vagina.
it is known that the cancerous or precancerous lesions which develop most frequently on the outer partof the mouth ofthe cervix (Le. the vaginal portio) are characteristically fria- Me. For example, the cells of such lesions break apart in great numbers with the slightest touch or trauma and become caught up in the mucous stream flowing from the cervix. Because a growing lesion ofa cancerous or precancerous type sheds myriad numbersof tumor cells with very light scraping, rubbing or aspiration, the obtaining of cells from the uterine cervix in order to diagnose the presence of a'cancerous condition or a precancerous condition has become a generally accepted technique. However, the procedure which have usually been used to collect the cells from a patient have usually required the services of a physician or other trained personnel. Because of this, it has frequently been inconvenient for a patient to be available for the cell collection. Also, in view of the usual simplicity involved in collecting the cells, physicians have in some instances been required to spend time in collecting the cells which could beotherwise spent on other medical care.
Heretofore. various techniques have been used in order to collect the necessary cells from the uterine cervix of a female patient. In some instances; the techniques have utilized a scraping instrument which has been constructed to scrape the cells from the squamo-columnar junction of a cervix. The
scraped cells have been removed by means of the scraping instrument upon which the cells have become deposited and placed on suitable slides for subsequent inspection and cytological study. However, in many cases, these instruments have not been capable of ensuring the removal of the cells necessary for an accurate cytological study from the body of the patient. Also, these instruments have usually not been capable of encasing the collected cells in a suitable manner for mailing to a laboratory for analysis.
These various techniques which have been used for cell collection have sometimes relied on the use of alcohol to wash thecells away from the cervix and to fix the cells for preservation until inspection takes place. However, alcohol has been found to change the appearance of the cells when the cells are afterwards deposited on a slide for inspection at a laboratory.
in addition. alcohol has frequently caused an irritating sensation on the internal tissues of the patient during the cell collection procedure. Further. alcohol has been found 'to dry out or otherwise evaporate such that the. fixed cells on a slide can become exposed to air should too long a time transpire before a laboratory analysis is made on the collected cells.
Accordingly. it is an object of the invention to provide a simple'cytological instrument which is capable of self-use.
[t is another object of the invention to obtain cellsfrom a cervix in a simple reliable manner for accurate cancer or precancerous diagnosis.
it is another object olthe invention to simultaneously scrape and apply suction by aspiration and encase cells in a preservative gel from a uterine cervix for cytological study.
It is another object of the invention to provide a cytological instrumentwhich is mailable.
it is another object of the invention to provide a cytological instrument which is capable of scraping cells from a cervix and of encasing the cells within a preservation gel within the instrument for subsequent mailing to a laboratory.
Briefly, the invention providesa technique for collecting cells from a female patient's cervix o'r vagina in a manner wherein the cells are scraped from the cervix or vagina and immediatelythereafter encased in a gel-like preservative on the surface of and within a cytological instrument for subsequent mailing. The instrument of the invention is constructed of a hollow tube having a collapsible bulb at one end and a scraping and aspiration head at the other end opposite the collapsible bulb. The scraping and aspiration head is of hollow construction and is provided with a series of spaced longitudinal ribs for scraping purposes and a plurality of holes between the ribs for aspiration purposes; the holes of the head communicating through the hollow interior of the head with the interior ofthe tube. in addition, the head is-ot' a tapered shape at the forward end to facilitate insertion into the vagina while the tube is provided with a pair of rings to indicate the proper degrees of penetration of the instrument.
The instrument of the invention also has a cap which is sized to slidably fit over the scraping and aspirating head when the instrument is not in use and when the instrument is being mailed to a laboratory.
In order to facilitate removal of the cells, a coating of gellike matter such as a glycerine chemical co rnplexlis formed about the outer surfaces of the head to act as a preservativeto encase the cells. In addition, a coating of the gel-like matter is placed within the interior of the head, The coating also entraps cells during the scraping action so that the cells are aspirated back into the head due to the vacuum created by the collapsing and subsequent expansion of the bulb on the end of the instrument. The gel coating .thus serves to encase the aspirated cells and preserve the cells in the condition they are in upon scraping fromthe cervix or vagina. Further, the inside of the cap which is placed over the head of the instrument is coated with the gel-like matterso as to further ensure the preservation of the cells while being transported after removal. i
In order'to collect a sample of cells, for example from the cervix, the cap is removed from the head of the instrument of contact is made with the uterine cervix as indicated by a slight resistance to further passage. This corresponds to the passage of the first ring into the vagina. When completely inserted, the bulb of the tube is grasped and squeezed to expel air and to create a vacuum around the head of the instrument. The. bulb is then released and usually remains in flat deflated form. The tube is then rotated two or three times so that the ribs on the head scrape the cells from the cervix. Next, the instrument is gradually withdrawn. During withdrawal, pressure is no longer applied to the bulb so that thebulb expands to resume its normal shape. Also, during expansion of the bulb, the cells which have been scraped from the cervix and encased in the gel coating are aspirated into the head of the instrument. After removal, the cap is immediately replaced over the head and the entire instrument is placed in a mailing container formailing to a laboratory for cytological study.
In order to remove the collected cells from the cytological instrument, the cap is removed and half-filled with a SOpercent alcohol or saline and the head of the instrument is inserted into the cap to flush out the cells from the instrument release the cells into the fluid. The instrument is then discarded and the cap is centrifuged. After the supernatant is poured oft and another quantity of 50 percent alcohol is added, the cells are resuspended by shaking and then the cap is again centrifuged. The supernatant is again poured olf except for 2 or 3 drops. The cell pellet is then mixed with 2 or 3 drops of alcohol with a capillary pipette. After drawing up the solution, 2 or 3 drops of suspended material is placed on a slide. After air drying, staining is carried out under normal procedures. The slides can be readily interpreted as excellent well-preserved cells with clear definition suitable for rapid definitive cytodiagnosis are provided.
These and other objects and advantages of the invention will become more apparent from the following detailed description and appended claims taken in conjunction with the accompanying drawings in which:
FIG. 1 illustrates a cytological instrument according to the invention;
FIG. 2 illustrates an end view of the head of the instrument of FIG. '1; and
FIG. 3 illustrates a view of the instrument of HG. l with a cap over the head in a stale ready for mailing.
Referring to FIG. I. the cytological instrument 4 includes a straight plastic tube 5. for example of polyethylene. a collapsi ble bulb 6 of suitable plastic material integrally formed on one end ofthe tube 5 and a scraping and aspiration head 7 fitted in the opposite end of the tube 5. The tube 5 which is approximately 5 inches in length and three-fourths inches in diameter is provided with a pair of fixed indicating rings 8,9 which are ofa size to be felt by a finger and which are spaced at points. for example, 4 inches and 5 1/2 inches from the top of the head 7.
Referring to FIGS. l and 2, the head 7 which is conically shaped at its forwardend is provided with a series of upstand ing ribs 10, for example six, which run longitudinally of the head and which provide scraping edges for the instrument 3. In addition, the head 7 is provided with a plurality of aspiration holes ll, for example, three, which are disposed in the conical tip between the ribs to afford passage for fluids between the interior of the head and the spaces between the ribs. The head 7 is sized to fit securely in the tube 5 and is about 0.60 inches in diameter and about 2.9 inches in length. The ribs 10 extend along the head 7 to the point where the head 7 enters the tube 5.
Referring to FIG. 2, the ribs 10 are of a cross-sectional shape so as to have an apex which is suitable for scraping cells such as the cells of a cancerous or precancerous lesion from the vaginal portio of the cervix. For example, the apex can be sharp or can be rounded.
Referring to FIG. 3, the instrument 3 is also-provided with a cap 12 which is sized to slidingly engage over the head 7. This cap 12 can be made ofany suitable material and is ofa length. for example. about 2.9 inches, to fully encompass the portion of the head 7 extending out of the tube 5 and of an outer diameter so as to present a compact instrument unit for m ail ing purposes.
.The interior ofthe head 7 which communicates through the interior of the tube 5 with the bulb 6 is coated with a gel-like matter such as a glyccrine chemical complex made up of about 95 percent glycerine with the remainder being aromatic and coloring additives for perfuming and coloring purposes. The charge of glycerine is initially placed within the head during assembling of the instrument or at some other suitable time in a suitable manner prior to use. In addition, a coating of the same glycerine is formed on. the exterior surfaces of the head 7 and on the interior surfaces ofthe cap l2.
When assembled for use (FIG. 3) the cap 12 is in place over the head 7. Thus, before a patient uses the instrument, the cap l2 is removed. This can be accomplished by a slight rotation of the cap 12 in order to overcome any suction force on the cap 12.
The instrument is capable of being used by the female in dividual or by her physician in taking cell samples, for exam ple, where the richest concentration of freshly desquamated cervical cells is yielded. that is. from the squamo-columnar junction ofthe cervix. In the case where the patient utilizes the instrument 3 herself, the cap 12 is first removed. The instrument 3 is then inserted gently into the individuals vagina until the head 7 meets firm resistance beyond the first ring 8 with the desired area of the cervix. The glyccrine coating on the head 7 provides a suitable lubricating action during this time for ease of passage of the instrument. Also, at this point, the first ring 8 will have passed into the vagina while the second ring 9 usually remains visible. Next, the bulb 6 is grasped and squeezed to expel air from the instrument 3. The bulb is then released. However, the bulb usually remains in the deflated condition due to the creation of a vacuum. The tube 5 is then rotated in order that the ribs 10 can scrape the cells from the adjacent areas of the vaginal portio ofthe cervix where cancer is prone to develop. As the head 7 rotates and the ribs 10 contact the vaginal portion, innumerable cells are desequamated and many adhere to the coating on the head. Thereafter, the instrument is gradually withdrawn without any further squeezing of the bulb 6. During withdrawal the bulb 6 inflates so that lhc cells scraped from the cervix and desquamated into the mucus from a cervicalor uterine lesion are aspirated into the head 7. The actual aspiration of the cells takes place chiefly while in contact with the vaginal portio ollthe squamo'columnar junction of the cervix. Other cells also become entrapped in the coating remaining on the exterior surface of the head 7. The cells encased within the glycerine remain in their scraped state as the glycerine serves remarkably as a cell preservative.
After removal, the cap 12 is replaced over the head 7 and the entire instrument is placed in asuitablc mailing container (not shown) for mailing to a suitablelaboratory for cytological analysis.
Where a physician takes the cell sample, the above procedure is also followed, with or without a speculum, and in addition a completedpatient history form can be placed in the mailing container. The advantageto the physician is such that the procedure becomes a simple, quick. painless part ofa routine pelvic examination without any need to prepare slides. to use liquids and to fix the cells.
It has been found that the cells which are encased within the glycerine complex contained within and coated on the instrument 4 have been preserved in excellent condition for cytological diagnosis. Because of this, there is no need to fix the cells in alcohol as has been followed previously. Further, since the glycerine has a higher viscosity than the alcohol previously used there has been little flow which might tend to float the scraped cells away from the instrument. Also, the glycerine has been found to retain moisture in the cells by virtue of the encasement of the cells while simultaneously protecting the cells against air except for the slight amount of oxygen initially picked up upon aspiration. Still further, it is believed that the glycerine may have a useful fixing effect on the encased cells.
In order to remove the cells from the instrument 4 ofthe in vcntion for microscopic analysis, alcohol or a saline solution is used to dissolve the glycerine. For example, where alcohol is used, the head of the instrument is inserted into the cap to which has been added 5 to 6 ml. of 50 percent alcohol. The bulb is then squeezed to expel the glycerine encased cells and the resulting solution is then centrifuged for from 3 to 5 minutes at about 1500 rpm. After the supernatant is poured off, another 5 to 6 ml. of 50 percent alcohol is added to the tube and the tube is shaken to resuspcnd the cells. Next, the solution is again centrifuged for from 3 to 5 minutesat about 1500 rpm. Thereafter, the supernatant is poured off except for 2 to 3 drops and the remaining cell pellet is mixed as with a capillary pipette with 2 to 3 drops of alcohol. Finally, the solution is drawn up and 2 to 3 drops of suspended material are placed on a slide. After air drying, a staining procedure can be carried out. for example. with a Papanicolaou trichrome stain or other suitable stain.
The invention thus combines the two methods ofcell collection proved most efficient for diagnosis of early uterine cancer. That is, the scraping of cells directly from the vaginal portio of the uterine cervix where cancer is prone to develop and the aspiration ofcells scraped from the cervix and desqua mated into the mucus from cervical or uterine lesions. The technique of the invention has demonstrated a diagnostic accuracy of lOO percent in cases of infiltrating cervical cancer, 98 percent in cases of carcinoma in situ and )5 percent of cases with precancerous dysplasia on known previously diagnosed cases.
The importance of the invention in small early lesions is highly significant since the strong cell collecting mechanisms of scraping and aspiration have yielded excellent diagnostic specimens as well as colonies of precancerous virus-infected halo cells, ideally suited for research study. The instrument may also serve usefully to collect living cancer cells for preservation prior to tissue culturing for research purposes. The instrument of, thc invention has also been found to be entirely adequate for hormonal studies of menopausal women to determine the estrogenic or maturation index. Also, the instrument has proven useful in confirming the presumptive diagnosis of early pregnancy and to aid in the diagnosis and management of threatened abortion. lt'has also been helpful in sterility studies and to identify and study spermatozoa. I
IV A cytological instrument for collecting cells from a patient comprising:
an elongated straight tube; a collapsible bulb on one end of said tube for expelling and aspirating air through said tube; v
a head mounted at the opposite end of said tube said head including a conically shaped surface at the forward end thereof. a series of spaced ribs extending longitudinally of said head and said forward end and disposed in upstanding relation to said surface, each rib having an apex projecting from said head and said forward end for scraping of cells from a lesion, and at least one hole disposed in said conically shaped surface between a pair of said ribs communicating the exterior of said head with the interior of said tube and bulb for aspiration of the scraped cells through said hole into said head upon inflation of said bulb; and
a coating of a glycerine chemical complex on said conically shapedsurface for encasing cells therein to preserve the cells for subsequent analysis.
2. A cytological instrument as set forth in claim I wherein said tube and said bulb are ofplastic material.
3. A cytological instrument as set forth in claim I further comprising a cap slidably mounted on said tube over said head for covering ofsaid head during transportation.
4. A cytological instrument as set forth in claim 1 further comprising at least one indicating ring mounted on said tube at a predetermined distance from the forward end ofsaid head for indicating the depth ofpenetration into a patient.
5. A cytological instrument for collecting cells from a uterine cervixfor cancerous and precancerous diagnosis comprising:
,an elongated straight tube;
a collapsible bulb integrally mounted on one end of said tube: v ahead mounted in the opposite end of said tube for penetration to the uterine cervix, said head having a conically shaped surface at the forward end thereof,.a series of ribs projectingoutwardly from said surface for scraping cells from the cervix upon rotation of said tube and said head,
and a plurality of holes in said surface for aspiration of the scraped cells into said head, each said hole being disposed between a pair of said ribs in communication with the interior of said tube and said bulb; and
a coating ofa glycerine chemical complex on said conically shaped surface for encasing cells therein to preserve the cells for subsequent analysis.
6 A cytological instrument as set forth in claim 5 wherein said tube, said bulb and said head are each made of plastic material whereby the instrument is capable of mailing.
7. A cytological instrument as set forth in claim 5 which further comprises a pair of indicating rings mounted on said tube for indicating the depth ofpenetration into a patient.
8. A- cytological instrument as set forth in claim 5 which further comprises a charge of a glycerine chemical complex in said head, wherein said charge of glycerine chemical complex encases the scraped cells when aspirated back into said head upon inflation of said bulb with the encased cells therein.
9. A cytological instrument as set forth in claim 8 wherein said chargeof glycerine chemical complex includes percent pure glycerine.
10 A cytological instrument as set forth in claim 8 which further comprises a cap slidably mounted over said head for enclosing said head whereby the openings in said head are covered during mailing.
11 A method of collecting cells from the squamo-columnar junction ofa uterine cervix comprising the steps of:
inserting a cytological instrument having a head including a series of projecting scraping ribs thereon, a plurality of holes between the ribs and a coating of glycerine thereon into the vagina; I
advancing the head of the instrument into contact with the cervix;
thereafter rotating the head of the instrument to scrape cells from the cervix for encasement in the glycerineon the head ofthe instrument in contact with the cervix; and
subsequently withdrawing the instrument from the vagina while simultaneously aspirating the glycerine and scraped cells into the head of the instrument for encasement therein for subsequent cytological analysis.
12. A method as set forth in claim 11 further comprising the step of covering the head of the instrument after withdrawal for transportation and mailing of the encased cells.