United States Patent [191 Zalucki 1 3,800,781 Apr.2,1974
[ SPEC lMEN-TAKING DEVICE [76] Inventor: Kazimierz Zalucki, 7 Holyoke St.,
Easthampton, Mass. 01027 [22] Filed: May 30, 1972 [21] Appl. No.: 257,595
[52] U.S. C1. 128/2 B, 128/2 W, 128/304 [51] Int.Cl A6lb 10/00 [58] Field of Search 128/2 W, 2 B, 2 R, 304, 128/262, 269, 263
[56] References Cited UNITED STATES PATENTS 5/1972 Moyle, Jr. et a1. 128/2 B 11/1970 Ayre 128/2 B 3,086,527 4/1963 Forrest 128/2 W 2,835,246 5/1958 Boettger 128/2 W 3,394,699 7/1968 Koett 128/2 B 3,592,186 7/1971 Oster 128/2 B Y \0 22 3e 44 I2 McDonald 128/2 B 3,037,495 6/1962 Naz 128/2 13 3,500,819 3/1970 Silvcrman.... 128/262 X 1,098,222 5/1914 Brascficld [28/262 FOREIGN PATENTS OR APPLICATIONS 215,350 2/1908 Germany 128/2 W Primary ExaminerKylc L. Howell Attorney, Agent, or Firm-Shlesinger, Arkwright, Garvey & Dinsmore [57] ABSTRACT A cylindrical tube has a retractable specimen gathering piece at one end thereof connected to a reciprocable activating member which extends out of the other.
end of the tube, the tube having a cylindrical cover into which the specimen gathering end thereof is inserted, the cover containing information identifying the person from whom the specimen is taken.
9 Claims, 3 Drawing Figures 1 SPECIMEN-TAKING DEVICE BACKGROUND OF INVENTION This invention relates to specimen gathering devices for obtaining samples from inaccessible parts of body cavities.
It is the usual practice to employ trained medical personnel to obtain specimens and cultures for analysis from body cavities, such as the vagina, rectum, nose, ears, mouth or throat. The care that must be taken to obtain a specimen from the desired area of interest, precluding of contamination of the specimen taken, and minimizing of the chance of injury to delicate cavity areas, has required the use of trained personnel.
Consequently, it has been necessary for individuals to make appointments and to appear at doctors offices or hospitals to have tests made. This requirement entailed loss of time and considerable expense to the individual, contributing toward a negligent and procrastinating attitude regarding many tests that should be taken at regular time intervals.
The present invention seeks to correct this situation while making it possible for the individual to conveniently, safely, and correctly obtain their own specimen or culture which can then be forwarded directly to the laboratory for analysis.
SUMMARY OF INVENTION Accordingly, this invention contemplates providing a specimen gathering device which can be safely usedby untrained individuals to obtain their own specimens which can then be sealed and forwarded to a laboratory for testing and evaluation.
The specimen taking device is designed so that it is self-contained, and can be self-administered. The samples are sealed automatically to prevent contamination, and the device inserted within a container having identification data thereon. The entire assembly can then be mailed to the laboratory.
The specimen taking device permits an individual to safely obtain specimens from remote internal areas of DESCRIPTION OF THE DRAWINGS FIG. 1 is a perspective view of the two main parts of the invention.
FIG. 2 is a sectional view of the assembled unit.
FIG. 3 is a partial section of the insertion tube with the probe in extended specimen gathering position.
DESCRIPTION OF THE INVENTION FIGS. 1 through 3 show the preferred embodiment of the instant invention. FIG. 1 shows the specimen-taking device generally indicated 10, in perspective, with the tubular container orcover 12 removed. Thecontainer 12 has anidentification label 14, which provides space for the name and the date to be placed thereon, as well as an identification or serial number. It is possible that such a label could be used to provide complete data, including the return address of the individual submitting the specimen. This would permit the laboratory to remove the label after the tests were completed and to affix it to a return envelope in which the results of the tests on the specimens by the laboratory were to be mailed back to the individual submitting the specimen.
Thecontainer 12 is of hollow construction and has an enclosedend 16 and anopen end 18 which fitsover and around the cylindricalinsertion tube assembly 20.
FIG. 2 which is a sectional view of the assembled specimen-taking device shows in more detail the structural configurations of the device. The cylindrical in-, v
sertion tube 20 has a roundedannular scraping edge 22, and anannular sealing surface 24 on the interior of theinsertion tube 20 immediately adjacent to the annular scraping edge 22.- The other end of thecylindrical insertion tube 20 has a flangedannular seal construction 26 having an annular negative slopedsealing lip 28.
FIG. 2 shows the assembled specimen-taking device as it would be sold and as it would be shipped after use to the laborabory for testing. The specimen gathering piece generally indicated at 30 isshown in FIG. 2 in the retracted sealed position. It has an outerhemispherical probe section 32 and on the inner probe section is a reduced and tapered sample gathering section containing longitudinally extending ferrules 34'which contact and gather specimens. The smooth inwardly taperingsection 36 of the insertion tube immediately behind theannular seal surface 24 is integral with a continuous tapered and conical shapedelastic diaphragm 38 which cooperates to form one of the walls of theannular chamber 40 between them and theferrule section 34 of thespecimen gathering member 30.
j Thenarrow neck section 42 of thespecimen gathering member 30 connects theferrule section 34 of the probe to the central portion of the generally conicallyshaped diaphragm 38. Theintermediate section 46 is an integral part of the central and outer side of the flex-'ible diaphragm 38, as well as constituting the inner end of theoperating stem 48 which has aknurled surface 50 to give good gripping action and prevent slipping when the user forces thestem 48 either inwardly or outwardly during the course of obtaining specimen material. 1
FIG. 3 shows the specimen gathering member in an, extended position, with the ferrules-34 exposed for obtaining sample material. It will be noted that thestem 48 has been pressed into theinsertion tube 20 so that theforward end section 46 presses against the flexibleplastic diaphragm 38 inverting it and permitting movement of thesample gathering member 30 outwardly from therounded scraping edge 22 of theinsertion tube 20 to expose theferrules 34. The outer portion of thediaphragm 52, as shown in FIG. 3 extends to a point approximately even with theannular sealing surface 24 at the end ofinsertion tube 20. After the area to bev sampled is engaged and the cultures taken, theknurled section 50 is grasped and thestem 48 pulled outwardly at the end adjacent theseal container interlock 26, retracting thespecimen gathering member 30 back into the tube and into the position shown in FIG. 2. The
specimen is contained within thesample holding chamber 40 in an airtight sealed configuration by the engagement of the outer periphery of the hemispherical member 32with thesealing surface 24 of thecylindrical insertion tube 20.
Thecontainer 12 is then placed over theinsertion tube assembly 20 and itsend seal groove 54 passed over the negative slopingsealing lip 28 of the seal con- OPERATION The invention is designed for use in gathering cells from the vaginal and cervical areas for cytologic evaluation, and is used for diagnosing in a manner similar to the commonly used Papanicolaou Smear test.
However, the invention can be used to gather samples from other remote portions of body cavities, such as the nose, ear and rectum. In each of these cases special adaptive configuration and sizes are assumed, but the basic principles are the same.
The preferred embodiment forconstruction of thespherical probe 30 is that of a low durometer reading rubber to permit insertion with the least discomfort. However, it is also contemplated that for mass production techniques, it would be desirable to use a suitably moldable type of soft resilient plastic for the construction of these devices.
It should be noted that the outer endannular surface 22 of theinsertion tube 20 has rounded'edges to facilitate penetration and preclude any injury to internal organs. Theferrules 34 will give a scraping action with a slight rotary motion, so as to induce cells and specimen to accumulate thereon and possibly move back along the tapered surface to thenarrow neck portion 42, prior to retraction of thespecimen gathering member 30 to its initial position within the tube. I
The configuration of thediaphragm 38 is preferred, but it is understood that there may be some variation in this configuration to permit the hinging and moving action desired when thestem 48 is reciprocated.
The device, being designed for self-use in gathering specimen samples permits thecover container 12 to be readily removed by pulling it free from theinsertion tube 20. Theinsertion tube 20 has a smooth exterior surface, and for use, surgical jelly is preferably applied thereto to provide lubrication when theinsertion tube 20 is forced into the cavity and subsequently rotated.
pressed down into sealing engagement with the sealingflange section 26 of the insertion tube as shown in FIG. 2 and described above. Thelabel 14 is then filled out and the entire assembly mailed to the laboratory for test and evaluation.
With regard to the identification system, it is also.
possible to provide a coded identification number for purposes of identification, so that the name of the person submitting the sample would remain anonymous. In this instance the identification number would be permanently imprinted or stencilled on the container tube.
It can readily be seen that the subject invention makes possible the use of a selt administered device which is of simple and cheap manufacture, permits the taking of samples in the privacy of ones home, and eliminates the need for trained medical personnel to take an accurate sample which can be sealed.
The parts themselves could be produced for substantially less than a dollar, and the pans could be sterilized and sealed to preclude infection.
While this invention has been described, it will be understood that it is capable of further modification, and this application is intended to cover any variations, uses and/or adaptations of the invention following in general, the principle of the invention and including such departures from the present disclosure as come within known or customary practice in the art to which the invention pertains, and as may be applied to the essential features hereinbefore set forth, as fall within the scope of the invention or the limits of the appended claims.
the forward end of the elongated tubular member and configured and disposed so that it can be re-. tracted into the forward end of the tubular support member;
c. hinge means connected to the rear of the specimen gathering member and to the inside of the tubular support member for permitting movement of the sampling member into and out of the forward end of the tubular support member,
d. an activating rod connected to the specimen gathering member at its rearward end and extending through said tubular support member and out of the rear end of the tubular support member,
e. sealing means defined by the forward end of the tube and a portion of the sampling means for sealing the specimen taken by the specimen-gathering member.
2. The device for obtaining specimens from internal areas of body cavities as set forth in claim l, wherein:
a. a removable cylindrical cover member is disposed over the elongated tubular support member covering the forward end thereof and being in sealing engagement with the elongated tubular support member, b. label and identification means is contained on the outer surface of the cover member. 3. The device for obtaining specimens from internal areas of body cavities as set forth in claim 2, wherein:
a. the label and identification means includes an area for a return address which is removable from the cover member.
4. The device for obtaining specimens from internal areas of body cavities as set forth in claim 1, wherein:
a. the specimen gathering member includes a forward hemispherical section, and a rearwardly tapering section which has specimen collecting means thereon.
6. The device for obtaining specimens from internal.
areas of body cavities as set forth in claim 5, wherein:
a. the specimen collecting means includes a plurality of longitudinally extending ridges.
7. The device for obtaining specimens from internal areas of body cavities as set forth in claim 1, wherein:
a. the seal means includes an annular sealing surface adjacent the forward end of the insertion tube which engages the periphery of the specimen gathering member,
b. the specimen gathering member includes a forward hemispherical portion which engages the annular sealing surface of the insertion tube, and
c. the specimen gathering member also includes a specimen gathering section at the rear of the hemispherical portion, and immediately adjacent the hinge means, on which specimen collecting means is disposed.
8. The device for obtaining specimens'from internal areas of body cavities as set forth in claim 1, wherein:
a. the hinge means is a flexible member and is integrally connected to the junctureof the specimen gathering member and the activating rod.
9. The device for obtaining specimens from internal areas of body cavities as set forth in claim 1, wherein:
a. the elongated tubular support membenthe specimen gathering member, the hinge member, and the activating rod are all one continuous unitary molded plastic piece.