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Publication numberUS3877464 A
Publication typeGrant
Publication dateApr 15, 1975
Filing dateAug 17, 1973
Priority dateJun 7, 1972
Publication numberUS 3877464 A, US 3877464A, US-A-3877464, US3877464 A, US3877464A
InventorsVermes Andrew R
Original AssigneeVermes Andrew R
Export CitationBiBTeX, EndNote, RefMan
External Links: USPTO, USPTO Assignment, Espacenet
Intra-uterine biopsy apparatus
US 3877464 A
Abstract
Biopsy apparatus for collecting specimen cell matter from the endometrium of the uterus comprises an introducer tube and a biopsy sponge on the forward end of a long flexible shank. The introducer tube has a lead portion sized to comfortably enter and occupy the endocervical passage and includes an enlarged outwardly located chamber to occupy the vagina. The chamber facilitates manipulation of the biopsy sponge during specimen collecting within the uterine cavity. Shoulder means associated with the introducer tube operate upon coming against the cervix to limit the depth of insertion of the lead portion of the introducer tube.
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Description  (OCR text may contain errors)

United States Patent [191 Vermes INTRA-UTERINE BIOPSY APPARATUS [76] Inventor: Andrew R. Vermes, 1020 Fifth Ave.

West, Olympia, Wash. 98501 [22] Filed: Aug. 17, 1973 21 App]. No.: 389,361

Related US. Application Data [63] Continuation-in-part of Ser. No. 260,370, June 7,

1972, abandoned.

[ 1 Apr. 15, 1975 Primary Examiner-Kyle L. Howell [57] ABSTRACT Biopsy apparatus for collecting specimen cell matter from the endometrium of the uterus comprises an introducer tube and a biopsy sponge on the forward end of a long flexible shank. The introducer tube has a lead portion sized to comfortably enter and occupy the endocervical passage and includes an enlarged outwardly located chamber to occupy the vagina. The chamber facilitates manipulation of the biopsy sponge during specimen collecting within the uterine cavity. Shoulder means associated with the introducer tube operate upon coming against the cervix to limit the depth of insertion of the lead portion of the introducer tube.

7 Claims, 4 Drawing Figures lNTRA-UTERINE BIOPSY APPARATUS This application is a continuation in part of my prior U.S. application Ser. No. 260.370. filed June 7. 1972 now abandoned.

BACKGROUND OF THE INVENTION l. Field of the Invention:

This invention relates to a medical biopsy apparatus for collecting cells from the female body for cytologie evaluation. More particularly. this invention relates to an apparatus including an introducer tube and a biopsy sponge on an elongated flexible shaft. The introducer tube establishes a smooth passage within the endocervix for the introduction of the biopsy sponge into the uterine cavity and includes a roomy chamber outward of the smooth passage permitting manual manipulation of the flexible shank of the biopsy sponge to facilitate the collection of specimen cell matter from the inter nally flaring endometrium of the uterus.

2. Description of the Prior Art.

An appreciation of past techniques and apparatuses employed in obtaining specimen cell matter from cervical. endocervical and intra-uterine surfaces and areas within the female body. practiced in aid of diagnosing for the presence of carcinoma. can be had from technical articles published for the edification of the medical profession.

It was stated in an article in February l972 that intrauterine sponge biopsy was then a new method to obtain samples of endometrium and endocervix cell matter suitable for histological evaluation. The analysis of specimens obtained by sponge biopsy were compared with material obtained by formal curettage and it was confirmed that the sponge biopsy technique had the ability to detect the presence of endometrium cancer in a very high proportion of the patients subjected to the technique. It was disclosed to employ an introducer tube of small diameter for placement in the endocervical area of the uterus. The tube contained. compacted therein in the forward end. a sponge comprising two folded halves juxtaposed to each other. Which. when extruded from the introducer tube assumed a veeshape as the halves spread apart within the uterus affording contact with opposed portions of the endometrium. The sponge is then withdrawn from the uterus through the cervical canal and through the vagina for subsequent histologic examination of the specimen thus collected. It will be apparent that by reason of the flexibility of the strand and its inability to function in torque or rotation the collecting sponge may not be manipulated within the uterine cavity. Further. in this technique there can be no discrimination between cell matter collected from the endometrium and cell matter collected from the endocervix or. for that matter from the cervix itself. This. because the method did not teach the withdrawal of the sampling sponge into the introducer while the same is in the cervical canal so that it could be shielded as the instrument withdrawn from the body cavity.

Another specimen collector comprised a tubular introducer member having substantially uniform cross sections throughout its length and provided with an entrant or lead portion and a follower portion separated by an outstanding flange which limited the penetration of the entrant portion into the cervical canal. However. this specimen collector which was in the form of a piston within the entrant end of the tube was manipulated forwardly and rearwardly by means of a shank having a substantially the same cross-section as the internal passage of the introducer tube. Thus lateral manipulation of the specimen collector vis-a-vis the axis of the introducer tube is precluded. Relative movement between the specimen collector and the introducer is substantially a linear function devoid of any lateral variations. It would appear that substantial angular manipulation of the introducer tube itself is required in order that the specimen collector may be directed in lateral paths to obtain and collect specimens of the inwardly flaring or spreading endometrium of the uterus. In order to accomplish this. substantial angular distortion ofthe cervical canal by means ofthe elongated introducer follower portion would be necessitated causing considerable discomfort to the patient under examination.

SUMMARY OF THE INVENTION In accordance with the instant invention biopsy apparatus for collecting cell matter from the endometrium of the uterus is provided which comprises a tubular thin-walled introducer member having a hollow lead portion and a hollow substantially larger follower portion. The introducer tube is passed through the vagina to a position where the lead portion is placed in the cervical canal. The larger follower portion provides a roomy chamber adjacently outward of the lead portion. Between the lead and the follower portions is an annular smoothly-faired shoulder which operates upon coming against the cervix to limit the depth of introduction of the lead or forward end of the introducer member. A biopsy sponge is carried into the body cavity. in place initially within the lead portion. The sponge has an elongated flexible shank extending rearwardly through the roomy chamber of the hollow follower portion and outward therefrom for manual manipulation. When it is desired to collect cell debris from the endometrium the obstetrician presses forwardly upon the flexible shank and ejects the biopsy sponge from within the lead portion and into the uterine cavity. By means of the extremely flexible shank and its relatively small crosssection vis-a-vis the passage of the lead portion. and of the chamber within the follower portion. upon the application of torque and by laterally cocking or distorting the shank the sponge can be caused to move in a somewhat conical path within the uterine cavity and thus collect specimens from practically the entire inner surface of the endometrium.

Among the important objects of this has been to provide a specimen collector adapted to withdraw fluids and cell matter from the endometrium of the uterus over a substantial portion thereof; to provide a new and improved introducer member for the biopsy sponge. comfortably acceptable to the patient so that the technique may be practiced in the offlce of an obstetrician: and to provide a specimen collector usable to obtain discriminate specimens from within the uterus and uncontaminated by cell matter that might be present in the endocervix at the cervix.

These and other and further objects and advantages of the present invention will become readily apparent from the following description and from the accompanying drawings.

BRIEF DESCRIPTION OF THE DRAWINGS FIG. I is an elevational view of a biopsy sponge and its elongated shank: I

FIG. 2 is a perspective view of the introducer tube with portions broken away for convenience of illustration:

FIG. 3 is a schematic view showing the use of the biopsy apparatus in the performance of the technique of collecting cell matter from with the uterus: and

FIG. 4 is a view in cross-section showing details of the leading end of the introducer tube and showing the specimen collecting sponge in place as during introduction of the apparatus into a body cavity.

It will be apparent to those skilled in the art that this invention is susceptible to embodiment in other forms than as shown in the drawings. The disclosure herein is to be understood as an exemplification of a preferred form of the invention carrying out the principles of the invention and is not intended to delimit the invention to the specifically illustrated embodiment. The scope of the invention will be more clearly pointed out in the appended claims.

DESCRIPTION OF THE PREFERRED FORM OF THE INVENTION In FIG. 3. wherein is depicted the situs of the human body in which this invention is particularly applicable. the uterus is shown as a pear-shaped. thick-walled. hollow muscular organ comprising the myometrium 12. the fundus '14. the cervix 16. The uterine cavity 18 within the uterus includes the endometrium 20 comprising the surfaces from which it is desired to collect cell debris and cell matter for cytological evaluation.

The Fallopian tubes are indicated at 22. 22. Within the cervix which is cylindrical. slightly swelled in its middle and about one inch in length. is the endocervical canal 24, the vagina 26 attaches to the cervix as shown. The mouth or entrance to the endocervical canal is spaced somewhat outward of the attachment of the walls of the vagina to the uterus. It is to be noted that the uterine cavity 18 is ofa generally conical shape flaring upward from the cervical canal toward the paired. trumpetshaped muscular canals comprising the Fallopian tubes 22. 22.

Referring to FIG. 2 the introducer member, designated as a whole by the numeral 30. comprises a lead portion 32 and a follower portion 34. The lead portion 32 is sized to be comfortably introduced through the cervix and into the endocervical passage. as shown in FIG. 3 until its inner end gains access to the uterine cavity 18. In a preferred form the lead portion 32. which is thin-walled. has internal passage 33 which flares slightly at 35 for a purpose later to be described. To accommodate the flare 35 the outer surface likewise curves outward slightly at 37. The whole tip of portion 32 is rounded and smoothed both to facilitate insertion into the endocervical canal and to insure expulsion and withdrawal of a biopsy sponge into passage 35 following the performance of the specimen collecting operation.

The follower portion 34 of the introducer tube 30 is I manipulation of the introducer tube by the gynecologist during insertion and its use within the body cavity.

Between lead portion 32 and follower portion 34 is the annular. smoothly-faired shoulder 40 which constitutes a limiting means in that. when the shoulder 40 comes against the mouth of the cervix as shown in FIG. 3. the depth of introduction of the lead or forward end 32 of the introducer member may not only be sensed by the obstetrician but in fact is physically controlled in that the tube 34 is of such size as it may not be forced into the endocervical canal.

The inner surface of the introducer member at the transition between passage 33 and the interior of chamber 36 is also smoothly faired as shown in FIG. 4.

In FIG. 1 is shown the biopsy sponge 50 which is cylindrical in shape having however. a tapered or somewhat pointed rear end 52. The flexible handle or shank 54 is securely embedded in the rear of sponge S0 in such a manner as to leave a substantial portion of the sponge ahead of the forward end of handle 54 to function as a cushion in the event that the sponge is pressed to a depth that it comes into contact with the inner surface of the fundus 14.

The sponge body 50 is formed of a flexible foam material derived from one of the synthetic plastic foams of which foamed polyethylene. foamed urethane or foamed vinyl chloride bases are typical examples. Suitable foams of the nature stated are classified in the plastics field as open-cell". The inter-cellular material of such foams is substantially nonabsorbent. Such foam materials are usually non-wetting or normally incapable of taking in and holding substantial quantities of liquid as is the case with the more commonly known cellulose sponges. The density of useful synthetic foams falls in the range of two to three pounds per cubic foot. Too coarse a cell structure should be avoided. Ordinarily the cells at the surfaces of body 50 should be fairly visible to the human eye. They should be shear-cut or "topped to form membrane-scraping collector cups. In other words. body 50 should be blanked or cut out of a larger piece of selected foam material by a shearcutting operation that insures that some of the peripheries of the numerous cells is removed to convert the cells from substantially spherical voids to partispherical cups. It is desirable that the sponge body 50 have an abrasiveness suitable to scrape and abrade from the endometrium 20 or from the surface of fundus 14 cell debris and cell matter which. on the mucousal lining, is quite tenacious and not ordinarily to be collected by a light wiping action.

The handle or shank 54 of the biopsy sponge should be not only relatively and materially smaller in crosssection than the passage 33 of the lead portion 32, but quite obviously very. very much smaller than chamber 36. Handle 54 should also be relatively rigid or stiff longitudinally but be flexible enough to be bowed and manipulated quite easily by the gynecologist during the specimen collecting operation.

The technique of employing the disclosed biopsy apparatus involves the insertion or introduction of the introducer member through the vagina 26 with the lead portion 32 being inserted into the endocervical canal 24 as shown in FIG. 3. Normally at this stage in the operation the biopsy sponge 50 is placed in passage 33 as shown in FIG. 4, in which case it will be somewhat compressed due to its normally being slightly larger than passage 33. The relative size between sponge 50 and passage 33 should be such that it will easily pass through passage 33 when it is desired to extrude it therefrom into the operating or specimen-collecting position as in FIG. 3 within the uterine cavity 18. Sponge 50 may be projected into cavity 18 to the extent shown in FIG. 3 in which case it comes against the inner surface of the fundus 14. By being rotated thereagainst cell matter is collected from that surface. The gynecologist may also take specimens of cell matter from the flaring endometrium walls 20 of the uterus by rotating the handle 54. When shank 54 is canted in passage 33. rotation will cause the sponge 50 to swing in a conical manner. This causes cell structure to be scrubbed or abraded from the endrometrium surfaces of the uterine cavity 18. The roomy chamber 36 in the follower portion 34 permits the obstetrician to manipulate the outward extending end of handle 54 and to bow it and flex it particularly within passage 33 whereby is obtained lateral displacement of the sponge 50 relative the axis of the introducer member 30. Also by manipulating the outer end of the introducer portion 34 with respect to the axis of the vagina 26 the linear direction of lead portion 32 can be changed thus swinging or canting the position of the sponge 50 into contact with the endometrium.

It should be apparent that use of the apparatus disclosed herein may be in offlce as distinguished from the prior techniques of curettage which usually were only practiced in a hospital or an elaborately equipped clinical facility. Thus this apparatus makes feasible mass screening of females. Minimal discomfort, the requirement of only a very brief time. nominal expense. and avoidance of hospital and clinic charges are among apparent advantages.

While it is desirable that the technique be practiced by trained personnel in the medical arts. it will be observed that the technique may also be carried out by trained paramedical people due to the simplicity of the technique and the inherent safeguards permitting the collection with accuracy and little or no discomfort of intrauterine biopsy specimens.

In this course of the disclosure reference has been made to gynecologists and obstetricians. The use of those designations should not be considered as limitative in respect of the use of the disclosed apparatus as it is intended for use by physicians and paramedical personnel and. on occasion. for self examination.

The apparatus disclosed is normally best produced of materials of a plastic origin not intended for reuse but economically priced for a single use and subsequent disposal. The stem or shank 54 should not be brittle or easily frangible since it must be capable of accommodating longitudinal forces inward and outward and. as well. bowing and flexing for the manipulations described. I have found that a thin-walled extruded PVC tube provides such desirable characteristics.

An appreciation of the invention can be derived from the following schedule setting forth preferred dimensions of various parts:

Sponge:

stem diameter, ca 2.5mm

stem length, ca 23 cm sponge diameter, ca 7 mm sponge length. ca 2.5/3 cm LII Tube:

length neck 32. ca 2.5/3 cm shoulder. ca 0.5 cm

body length ca 17 cm body diameter. ca 2.2/5 cm.

One particular advantage arising from the use of the disclosed apparatus and the technique of the conical manipulation of the sponge in the uterine cavity is that specimens may be collected from the cornus or converging openings to the Fallopian tubes 22. 22. Expericnce derived from curettage has shown that suspect tissue may be discovered in one cornu or in both. The ease with which the sponge herein may be manipulated increases the likelihood that very effective screening will occur.

What is claimed is:

1. Biopsy apparatus for collecting cell matter from the endometrium of the uterus. comprising:

a tubular. thin-walled. introducer member having an opening at both ends;

said member comprising a hollow. lead portion adapted to be comfortably introduced through the cervix into the endocervical passage and to reach the uterine cavity; said member also comprising an integral hollow elongated follower portion of substantially increased cross-section relative the cross-section of said lead portion and coaxially associated with the hollow of said lead portion whereby to provide a roomy chamber adjacently outward of said lead portion;

said introducer member having externally between the rear of said lead portion and the front of said follower portion an integral, annular. smoothlyfaired shoulder defining means to limit the depth of penetration of the forward end of said lead portion into the uterine cavity;

a surface-abrading biopsy sponge of a size to pass through said hollow lead portion: and

an elongated flexible shank having its forward end securely embedded in the rear of said sponge. said shank being disposed within said introducer member and being materially smaller in cross-section than the hollow of said lead portion and of a length to extend through-said introducer member and outward of the chamber of said follower portion when the sponge is inserted into the uterine cavity.

2. The structure of claim 1 in which the forward end of the hollow lead portion is internally flared.

3. The structure of claim 1 in which the biopsy sponge is slightly larger in cross-section than the hollow within the lead portion and is under compression during its passage therethrough.

4. The structure of claim 3 in which the rear of the biopsy sponge is conical.

5. The structure of claim 1 in which the introducer tube includes outstanding members at the rear of the follower portion to facilitate manual manipulation of said tube in the vagina.

6. The structure of claim 1 in which said shank is hollow.

7. The structure of claim 1 in which the annular shoulder of the introducer member is forwardly tapered.

Patent Citations
Cited PatentFiling datePublication dateApplicantTitle
US2839049 *Mar 25, 1954Jun 17, 1958Maclean Kenneth SAbrasive cytologic brush
US2847000 *Jul 2, 1957Aug 12, 1958Nieburgs Herbert EDevice for obtaining body cell specimens
US2905169 *Mar 10, 1955Sep 22, 1959Herbert E NieburgsDevice for cancer detection
US3228398 *Mar 12, 1963Jan 11, 1966Washington Ethical Labs IncVaginal cleanser
US3438366 *Jul 25, 1966Apr 15, 1969Hollister IncSpecimen collector
US3491747 *Aug 12, 1966Jan 27, 1970Robinson Ralph RCurette device
US3513830 *Oct 10, 1967May 26, 1970Wayne C KalayjianInstrument for obtaining body cultures
US3554185 *Feb 29, 1968Jan 12, 1971Kohl Gerald CCervical biopsy-sampling instrument
US3688763 *Jul 15, 1970Sep 5, 1972Cromarty RaymondDiagnostic device and method
US3712296 *Dec 8, 1970Jan 23, 1973Gradone FSwab device for medical specimens
US3777743 *Sep 29, 1972Dec 11, 1973Kendall & CoEndometrial sampler
Referenced by
Citing PatentFiling datePublication dateApplicantTitle
US3995618 *Jun 16, 1975Dec 7, 1976Richardson-Merrell Inc.Cervical tissue cell-gathering device
US4136680 *Jun 4, 1976Jan 30, 1979Transmed Corp.Self-contained apparatus for collection and maintenance of medical specimen and methods of using same
US4157709 *May 9, 1977Jun 12, 1979Ovutime, Inc.Probe for obtaining cervical mucus and process thereof
US4227537 *Mar 8, 1978Oct 14, 1980Tucson Medical Instruments, Inc.Endometrial brush with slidable protective sleeve
US4620548 *Jan 23, 1985Nov 4, 1986Accupap, Inc.Pap smear T-zone sampler
US4735214 *Sep 5, 1986Apr 5, 1988Berman Irwin RGastrointestinal diagnostic capsule and method of use
US4850970 *Jun 23, 1988Jul 25, 1989American Home Products, Corp.Two part mastitis cannula cap
US4862899 *Feb 29, 1988Sep 5, 1989Bucaro Russell JKit for home use detection of cervical and vaginal cancer
US4877037 *Oct 6, 1988Oct 31, 1989Minnesota Mining And Manufacturing CompanyTissue or mucus sampling device
US5009640 *Jan 19, 1989Apr 23, 1991The Upjohn CompanySlip cap for cannula use
US5031635 *Aug 27, 1990Jul 16, 1991Accu-Med CorporationPlastic molded biological sample collection swab
US5091316 *Apr 11, 1990Feb 25, 1992Becton, Dickinson And CompanyFor maintaining viable, uncontaminated microorganisms when innoculating cultures
US5137030 *Oct 2, 1989Aug 11, 1992Animal House, Inc.Diagnostic methods
US5192290 *Aug 29, 1990Mar 9, 1993Applied Medical Resources, Inc.Embolectomy catheter
US5253652 *Jan 25, 1993Oct 19, 1993Fast James ICytologic sampling device for collecting cervical and vaginal cell specimens
US5411509 *Sep 30, 1992May 2, 1995Applied Medical Resources CorporationClot removal system
US5456265 *Sep 28, 1993Oct 10, 1995Yim; Duck S.Endocervical brush assembly and method for obtaining tissue samples
US5483972 *Dec 19, 1994Jan 16, 1996Nabai; HosseinFor the repair of skin tissue
US5562680 *Mar 20, 1995Oct 8, 1996Hasson; Harrith M.Apparatus for assisting the performance of pelvic endoscopic procedures
US5697911 *Jan 17, 1995Dec 16, 1997Yarger; Richard J.Plug for a wound drain
US6346086 *Apr 23, 1999Feb 12, 2002Cook Urological Inc.Endocervical and exocervical cell collection device
US6454756 *May 24, 2000Sep 24, 2002Livestock Improvement Association Of Japan, Inc.Injector of sperm for artificial insemination or fertilized ovum for transplantation of domestic animal and method of operating thereof
US6576429Oct 26, 2000Jun 10, 2003Alimenta Diagnostics AbComprising a holder part and an expandable part; rectal insertion; protective cover for preventing sampling area from contact with inner wall and fluid during retraction; use in testing for food allergies
US6813520Jun 23, 1998Nov 2, 2004NovaceptMethod for ablating and/or coagulating tissue using moisture transport
US7512445Aug 3, 2005Mar 31, 2009Cytyc CorporationMoisture transport system for contact electrocoagulation
US7604633Oct 6, 2004Oct 20, 2009Cytyc CorporationMoisture transport system for contact electrocoagulation
US7674260Apr 28, 2005Mar 9, 2010Cytyc CorporationEmergency hemostasis device utilizing energy
US7731712Dec 20, 2004Jun 8, 2010Cytyc CorporationMethod and system for transcervical tubal occlusion
US7749173Oct 26, 2006Jul 6, 2010Daniel LarkinApparatus for simultaneously collecting exocervical and endocervical samples
US7846160Dec 21, 2006Dec 7, 2010Cytyc CorporationMethod and apparatus for sterilization
US8251918Jun 14, 2010Aug 28, 2012Daniel LarkinMethod and apparatus for simultaneously collecting exocervical and endocervical samples
US8282612 *Mar 6, 2009Oct 9, 2012Denise H. MillerMethods and devices for intrauterine absorption
US8323211Apr 24, 2007Dec 4, 2012Daniel LarkinSexually transmitted infection sampling device
US8439847Jun 14, 2010May 14, 2013Daniel LarkinMethod and apparatus for simultaneously collecting exocervical and endocervical samples
US8486060Sep 18, 2006Jul 16, 2013Cytyc CorporationPower ramping during RF ablation
US8506563Oct 19, 2009Aug 13, 2013Cytyc Surgical ProductsMoisture transport system for contact electrocoagulation
US8551082Mar 19, 2012Oct 8, 2013Cytyc Surgical ProductsRadio-frequency generator for powering an ablation device
US8652067Jul 17, 2008Feb 18, 2014Histologics, LLCFrictional trans-epithelial tissue disruption and collection apparatus and method of inducing and/or augmenting an immune response
US8734364Nov 7, 2013May 27, 2014Genetic Technologies LimitedDevice and method for obtaining a biological sample
EP0001718A1 *Oct 24, 1978May 2, 1979CHINOIN Gyogyszer és Vegyészeti Termékek Gyára RT.Apparatus and method for use in the removal of material from body cavities by suction
EP0187684A2 *Sep 21, 1981Jul 16, 1986Regents Of The University Of MinnesotaA test sample collection device
EP2395922A1 *Jan 25, 2010Dec 21, 2011Genetic Technologies LimitedBiological sampling device
WO1994016627A1 *Jan 21, 1994Aug 4, 1994James I FastCervical and vaginal cell specimens collecting device
WO1996022053A1 *Jan 17, 1995Jul 25, 1996Gynetech IncCervical tissue sampling device
WO1999021521A1 *Oct 26, 1998May 6, 1999Jagmohanbir Singh DillonVaginal introitus sampling system
WO2001030243A1 *Oct 24, 2000May 3, 2001Alimenta Diagnostics AbApparatus for intestinal sampling and use thereof
WO2010085841A1 *Jan 25, 2010Aug 5, 2010Genetic Technologies LimitedBiological sampling device
Classifications
U.S. Classification600/572, 604/117, 604/158, 604/60, 604/1
International ClassificationA61B10/02, A61B10/00
Cooperative ClassificationA61B10/0291, A61M2210/1433
European ClassificationA61B10/02U