US RE24666 E
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A. DRAGHI July 7, 1959 TAMPON Original Filed Dec. 5, 1955 2 Sheets-Sheet l INVENToR l ,D :uffa v ATTORNE July 7, |959 A. DRGHI R. 24,666
' TAMPON Original Filed Dec. 5, 1955 v f 2 Sheets-Sheet 2 INVENTOR Ana/,re ,D rayh rl United States Patent() TAMPON Andr Draghi, Stamford, Conn.
Original No. 2,844,150, dated July 22, 1958, Serial No. 550,981, December 5, 1955. Application for reissue March 16, 1959, Serial No. 799,828
3 Claims. (Cl. 12S-285) Matter enclosed in heavy brackets appears in the original patent but forms no part of this reissue specilieation; matter printed in italics indicates the additions made by reissue.
This invention relates to a tampon for detection of cancer. Moreparticularly it relatestoa tampon as a means for mass screening and detection of cancer of the pelvic region.
The frequency of advanced cancer of the pelvic region presents to the medical profession a disturbing picture. One author states that only a relatively smallpercentage of the cases of cancer of the cervix is detected in the early stage ofthe disease. This is .in spite of the various methods to detect cancer of the cervix which have been developed and are being used' by gynecologists today. Among vthe practical barriers to prompt diagnosis is the inability and the reluctance of many women to present themselves periodically to a physician for a gynecological examination whereby early evidence of cancer may be detected; this inability and reluctance is a direct cause of the high percentage of advanced cancer which occurs or develops in the pelvic region and particularly in the region of the cervix uteri. Furthermore the protracted gynecological examination of the patient which is necessary to obtain full diognostic information, is time consuming for the physician and nurse and accordingly any such routine periodical examination may be prohibitively expensive for the patient, and the medical organization undertaking it.
Complete diagnosis to determine whether and to what extent one has cancer must require a thorough gynecological and pelvic examination and biopsy. Preliminiary diagnosis to determine if there are present any indicia of cancer however, may be asserted by taking a sample of cells which are present in the cervical canal and the vagina and the subsequent microscopic analysis of these cells. While a thorough gynecological examination and biopsy should be performed in those cases in which the preliminary diagnosis indicates cancer, the preliminary diagnosis can serve to screen many women and thus initiate the early treatment of those who have indications of cancer.
It is therefore an object of this invention to provide a means for mass screening for cytological detection of carcinomas of the pelvic region.
A further object of this invention is to provide through the cooperation of the patient herself, an accurate, inexpensive means by which cells present in the pelvic region can be collected and thus screen large numbers of women thereby reducing the percentage of cases having advanced pelvic cancer.
Another object of this invention is to provide a means for sampling vaginal cells, which can be inserted by the patient herself, and will provide satisfactory smears for laboratory evaluation without the necessity for elaborate clinical facilities.
In accordance with the present invention a cancer de- Re. 24,666 Reissued July 7, 1959 lee tection tampon is inserted into the vaginal cavity in a manner like that for the well known catamenial tampon and remains therein for a time specified by the physician. The tampon is then removed by the patient and given to a nurse who makes a smear on a slide according to the method described in articles appearing in vol. 7, No. 6 of Cancer at pages 1182 et. seq. and 1185 et. seq. and appearing in vol. 159, No. 12 of The Journal of the American Medical Association at page 1177 et seq.
A better understanding of the invention may be obtained by reference to the accompanying drawings in which:
Figure l is a perspective view of one type of jacket according to the invention which is placed over a supporting body;
Figure 2 is a perspective view of a vaginal supporting body suitable for use with the jacket of Figure 1;
Figure 3 is a perspective view of the jacketed tampon ready for use;
Figure 4 is a perspective view of another type of jacket suitable, according to the invention, to be assembled over a cotton pad and the assembly compressed to form the detection tampon;
Figure 5 is a perspective view of an uncompressed cotton pad for use with the jacket of Figure 4;
Figure 6 is a perspective view of the assembled detection tampon showing the jacket turned inside out so that the seam is on the inside and showing the jacket ltted over one end of the uncompressed cotton pad and the two sewn together with the string; and
Figure 7 is a perspective view of the assembled detection tampon of Figure 6 after it has `been compressed into a cylindrical form.
Referring to Figures l and 2 there is shown supporting body 10 similar in size and shape to the type generally used for catamenial tampons. Body 10 is made of a size and of a material which is sufficiently flexible to be comfortable carried in the vaginal cavity, in a preferred example this may be about 1/2" x 2%. In the embodiment illustrated a cotton liber body is employed as the supporting means and is covered -by jacket 12.
Jacket 12 is formed from a piece of material sewed into a generally round tube with a closed but enlarged cap 13. Jacket 12 is made so that it covers one end and extends approximately one-half the length of body 10. The fins of material 16 along the seams 18 are on the inside of the jacket leaving the outside smooth. In the present embodiment jacket 12 is made out of a closely woven, sheer cloth which is manufactured from a nonabsorbent, relatively line, continuous filament yarn such as nylon.
Figure 3 shows body 10 and jacket 12 assembled into a detection tampon 14 which embodies features of the invention. Tampon 14 is shaped into a generally round form. One end of body 10 is covered by closed end 13 of jacket 12 and the other end is attached to a removal string 22. Removal [strip] string 22 is sewed into the tampon 14 by the same stitching that securely aixes jacket 12 to body 10 forming tampon 14.
Another embodiment of the invention is shown in Figures 4, 5, 6 and 7. The jacket 12a of Figure 4 is slipped over cotton pad 10a shown in Figure 5. The jacket 12a is similar to jacket 12 shown in Figure l. Jacket 12a is a closely woven sheer cloth manufactured from relatively non-absorbent, continuous filament such as nylon. The cloth when folded back upon itself, as shown in Figure 4, is stitched along one edge extending from the fold and the edge opposite to the fold; but a very satisfactory jacket can be made from a longer and narrower piece of cloth folded back upon itself and stitched along opposite edges adjacent to the fold. Or a tubular fabric of the required width can be sewn across 3 one end; Thus it vvill be seen that the [essential] feature essentially identifying Fig'. 4 with these latter alternatives is that the jacket is closed on the sides and one end, and open at its other end and of a size adapted to containV cotton' pad 1'0a" as shown in Figure 5.
After the jacket 12a has been sewn as `,showt/n in Eigu1e 4', it is turned inside out leaving al smooth' exterior suface. t
Figurey 6 shows an uncompressed cotton pad' l10'a and jacket 12a assembled and stitched' as at 47 downn the center and to Withdi'awal cord 22a forming uncompressed tampon 14a. n V y t Figure 7 shows the assembled tampon14b comprising jcket'1`2a land cotton pad 10a after' the tampon has been compressed into a' cylindrical shape.y Surplus material at the top of the jacket forms ya chefs cap 13a.
The jacketY 12 and 12a holds Whatever cells co1- lected from the' b'o'dy cavity oil the surface of thjjkt: Because the cloth of the jacket is non-absoibe'nt these cells are notdehydate'dL and thus remain in"l a ifelativ'ely moisi:A conditionr which' enagtilesr a' more accurate' clinical evaluation. It has also been fond'niost satisfacfdy for collection of vaginal smears that the exteioi suvlface Z and 20aof the jacket 1'2 and 12a" be relatively smooth.
The n of material resulting from'the seam slild the'efoi'ebe made on the inside. y n The enlarged cap 13 and 13a which extends farthest intothe vaginal canal collects and retains in noist form many cells; While the specific reasons for theitnprovd sampling'- through use of the' enlarged cap 13 and 13a remain obscure at this time tests haver proven that a large percentage of cells arel collected on thecap 13 and 13a` and by` using a tamponiwith such a cap thesa'rnplig` of cells from the vagina is Lgreatly improved. n The pliability of tampons 14,l 1`4`a and" l4b permits the easy removal of the collected cells by evenly sin'eiat-A ing onto a microscope slide, with or withouty squeezing with finger pressure against its sides and advantageously rotatingthe tampon in contactwithv the slide.y
In the embodiments I have described the tampon is comprised of a jacket of non-absorbent, relatively tine, continuous filament yarn such as nylon and a supporting body of cotton fiber. Laboratory tests have conclusively indicated that the use of the non-absorbent supporting body is also practical for the collection of cells. Thus, for the collection of cellsuawplastic, rubber or other nonabsorbent supporting body with the nylon like jacket can be used.
1. A vaginal type tanpn compised of a supporting to said body and civiing one"v end' of said supporting body and the adjacentpqrtiqn ofutlhewbody, but extending beyondnit in a loose capaid acket bern a `tine-mes u f L j. Hg t a1 it 1255.279@ A Sep,r.29,;19,25 2267.030 H. nea 2311941