United States Patent
`
`119]
`
`I
`
`[11]
`
`4,227,537
`
`Oct. 14, 1980
`[45]
`- Suciu et al.
`
`
`[54] ENDOMETRIAL BRUSH WITH SLIDABLE
`PROTECTIVE SLEEVE
`
`OTHER PUBLICATIONS
`
`Webster’s Dictionary, G & C Merriam Co., Springfield,
`Mass, 1963, p. 648, “plastic”.
`“Expanded PTFE: It’s A Whole New Ballgame”, Plas-
`tics World, Jul., 1971.
`
`Primary Examz'ner—R-Jbert W. Michell
`Assistant Examz'ner—J. L. Kruter
`Attorney, Agent, or Firm——Cahill, Sutton & Thomas
`
`ABSTRACI‘
`[57]
`An endometrial brush and method of using, the endo-
`metrial brush including a slidable protective sleeve for
`protecting bristles of the endometrial brush from wet-
`ting and contamination by cervical tissue during inser-
`tion of the endometrial brush through the cervix and
`into the endometrial cavity of the patient. The protec-
`tive sleeve is composed of tubular flexible material
`which is slid forward along a shaft of the endometrial
`brush to cover the bristles during insertion. After the
`bristle section of the brush is in its desired position in the
`endometrial cavity, the protective sleeve is slid back-
`ward along the shaft, thereby uncovering the bristles.
`The handle is then manipulated to cause the bristles to
`scrape the walls of the endometrial cavity,
`thereby
`collecting sample tissue and/or cells. The brush is then
`withdrawn through the cervix. The collected sample is
`smeared on a microscope slide and analyzed.
`
`12 Claims, 15 Drawing Figures
`
`[75]
`
`Inventors: Thomas N. Suciu; Herbert J. Schmidt,
`both of Tucson, Ariz.
`
`[73] Assignee:
`
`Tucson Medical Instruments, Inc.,
`Tucson, Ariz.
`
`[21] Appl. No.: 884,634
`
`[22] Filed:
`Mar. 8, 1978
`[51]
`Int. Cl.3 ....................... .. A61B 1/00; A61B 10/00
`[52] US. Cl. ................................... .. 128/756; 128/357
`[58] Field of Search ............................ .. 73/425, 425.2;
`15/104.165, 104.2, 145, 169, 168, 184, 206;
`128/2 B, 2 N, 269, DIG. 14, 256, 357
`
`[5 6]
`
`References Cited
`U.S. PATENT DOCUMENTS
`
`Schwartz ............................. .. 15/206
`7/1934
`10/1960 MacLean . . . . . . .
`. . . . .. 128/2 B
`4/1975 Vermes .... ..
`.. 128/2 B
`12/1976
`I-{osono .. . . . .
`... . .. 128/6
`9/1977 Nigro ....... ..
`.. 128/263
`8/1978
`Chikashige .
`128/2 W
`ll/1978 Nollan ............
`128/2 B
`1/1979
`Southworth ....................... .. 128/213
`
`
`
`1,967,597
`2,955,591
`3,877,464
`3,998,216
`4,048,998
`4,108,162
`4,127,113
`4,136,680
`
`FOREIGN PATENT DOCUMENTS
`
`15/206
`671738 9/1929 France ............................. ..
`
`.. 123/2 B
`2305959 10/1976 France ................. ..
`1394925
`5/1975 United Kingdom ................. .. 128/2 W
`
`
`
`1
`
`H1s1o1og1cs, LLC
`p Exhibit 1011
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`1
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`U.S. Patent
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`Oct. 14, 1980
`
`Sheet 1 0f2
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`432279537
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`4,227,537
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`ENDOMETRIAL BRUSH WITH SLIDABLE
`PROTECTIVE SLEEVE
`
`-
`
`BACKGROUND OF THE INVENTION
`1. Field of the Invention
`The invention relates to brushes and methods for
`collecting sample tissue from an endometrial cavity to
`aid diagnosing of endometrial cancer.
`2. Description of the Prior Art
`For a number of years, the incidence of cervical can-
`cer was greater than the incidence of endometrial can-
`cer. In order to diagnose cervical cancer a reliable,
`inexpensive treatment,
`the well-known Pap test,
`is
`widely utilized to diagnose cervical cancer. The Pap
`test is widely accepted by physicians and patients be-
`cause of its reliability, low cost, convenience of applica-
`tion, and painlessness. Patients are not hesitant to peri-
`odically submit to the Pap test. Consequently, cervical
`cancer is usually diagnosed sufficiently early to be effec-
`tively treated. As a result of such effective treatment,
`the incidence of cervical cancer has become smaller
`than the incidence of endometrial cancer. This has oc-
`curred because until now, reliable, convenient, inexpen-
`sive, relatively painless methods and devices for obtain-
`ing samples of endometrial tissue and cells have not
`been available.
`One known collecting device for endometrial cell
`and tissue samples, called a Medoza Canula, includes a
`curved plastic stem to facilitate its insertion into an
`endometrial cavity and a head having annular plastic
`flanges which operate to scrape cells from the walls of
`the endometrial cavity. The Medoza Canula includes a
`retractable protective sleeve to cover the head and the
`plastic flanges thereof to prevent wetting and contami-
`nation during insertion of the device through the pa-
`tient’s cervix. Once the head of the Medoza Canula is
`properly positioned in the endometrial cavity, the pro-
`tective sleeve is retracted, exposing the plastic flanges.
`The handle is then manipulated forward and backward
`to cause the plastic flanges to scrape cells and tissue
`from the walls of the endometrial cavity. However, the
`Medoza Canula has a fixed depth limiting member
`which limits the depth of penetration of the head into
`the endometrial cavity. Consequently, for some patients
`the plastic flanges do not reach sufficiently deeply into
`the endometrial cavity to collect sample cells or tissue
`for analysis. Another disadvantage of the Medoza
`Canula is that the plastic flanges do not scrape the walls
`of the endometrial cavity sufficiently effectively to
`collect all of the cells and tissue which should be ana-
`lyzed for presence of cancerous cells. The plastic
`flanges do not effectively scrape loose tissue and cells in
`response to rotation of the handle. Further, the plastic
`flanges “pick up” loose cells, but do not effectively
`scrape or pick up cells’ or tissue which is very deep
`within the endometrial walls. This prevents analysis of
`a suitably broad spectrum of potentially cancerous cells
`which might be present in the tissue of the endometrial
`walls. Further, the adherance of scraped cells to the
`plastic flanges of the Medoza Canula is thought to be
`inadequate to ensure retention of such cells on the
`flanges during withdrawal of the head through the
`cervix. Finally,
`the plastic flanges of the Medoza
`Canula do not efficiently collect sample tissue and cells
`from the deepest portions of the endometrial cavity.
`This is a serious shortcoming, because endometrial can-
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`cer frequently begins its growth in the deepest portions
`of the endometrial cavity.
`Another known collecting device for endometrial
`cell and tissue samples is disposed in U.S. Pat. No.
`3,945,372, by Milan et al, issued Mar. 23, 1976. The
`endometrial tissue obtaining instrument described in the
`Milan et al patent includes a handle and a plastic spiral
`section which is inserted into the endometrium and
`rotated to collect endometrial tissue. This device does
`not have a protective sleeve, as does the above Medoza
`Canula. It is believed that the device of the Milan et al
`patent has the same general shortcomings as the above-
`described Medoza Canula, and additionally has the
`shortcoming that wetting of the spiral section occurs
`during insertion,
`thereby substantially reducing the
`adherance of endometrial tissue to the spiral section. It
`is also believed that the spiral section does not dig suffi-
`ciently deeply into the endometrial walls to collect as
`wide a spectrum of possibly cancerous cells and tissues
`as is desirable.
`Other methods of collecting endometrial cells and
`tissue include aspirator type devices (which operate to
`suck cells from the endometrial walls) and a type of
`device referred to as a “gravely jet washer”. Both of
`these types of devices require expensive motor driven
`mechanisms. Such machines are not ordinarily available
`in a physicians office. In both types of devices, the
`collected cells are collected in a fluid, which must be
`strained through a filter in order to collect the cells so
`that they can be placed on a microscope slide by analy-
`sis. This type of procedure is not of a type which can be
`economically routinely performed in a typical physi-
`cians office.
`It is an object of the invention to provide an inexpen-
`sive, efficient method of obtaining samples of endome-
`trial cells and/or tissue.
`It is another object of the invention to provide a
`method of obtaining endometrial tissue and cell samples
`which can be easily placed on a microscope slide for
`analysis.
`It is another object of the invention to provide a
`method of obtaining endometrial tissue which is suffi-
`ciently uncontaminated to permit accurate diagnosis of
`endometrial cancer.
`It is another object of the invention to provide an
`endometrial brush which may be inserted with mini-
`mum discomfort to the patient.
`It is another object of the invention to provide an
`inexpensive endometrial brush which efficiently col-
`lects a broad spectrum of endometrial tissue and cell
`samples.
`It is another object of the invention to provide an
`inexpensive endometrial brush which avoids wetting
`and/or contamination of its bristles during insertion and
`withdrawal of the endometrial brush.
`It is another object of the invention to provide an
`endometrial brush to efficiently collect endometrial
`tissue and/or cell samples from the deepest portions of
`an endometrial cavity.
`Briefly described, and in accordance with one em-
`bodiment thereof, the invention provides an endome-
`trial brush and method for efficiently and inexpensively
`collecting samples of endometrial tissue and/or cells
`from the walls of a patient’s endometrial cavity. The
`endometrial brush includes a handle, which may be
`permanently or detachably connected to a semi-rigid
`shaft. A flexible, slidable sleeve is provided on the shaft
`and can be slid forward along the shaft to cover the
`
`4
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`3
`bristles of the brush during insertion and withdrawal
`and can be slid backward along the shaft to uncover the '
`bristles in the endometrial cavity to permit scraping of
`sample tissue and cells therefrom. The semi-rigid shaft
`may be bent so that it conforms to the curvature of the
`passage through the vagina, cervix, and endometrial
`cavity of an individual patient. The shaft, when so bent,
`maintains its bent configuration so that when the endo-
`metrial brush is fully inserted, the bristles of the brush
`are suitably positioned for scraping and collecting sam-
`ple tissue and cells from the endometrial walls. The
`bristles are helically wound to form a helix along a
`segment of the shaft furthest from the handle. A small,
`rounded bead is connected to the extreme end of the
`shaft beyond the bristles. The diameter of the bead is
`sufficiently small to permit insertion of the endometrial
`brush through the patient’s cervix with minimum dis-
`comfort to the patient. The bead forms a seal with the
`inner surface of the flexible sleeve when the sleeve is
`slid forward to cover the bristles during insertion and
`withdrawal of the endometrial brush. In one embodi-
`ment of the invention, the rounded bead is omitted, and
`a group of end bristles fanning outwardly from the end
`of the shaft is provided to more efficiently scrape tissue
`and cell samples from the deepest portions of the endo-
`metrial cavity, where the probability of cancerous tissue
`and cells may be highest. According to the invention,
`the slidable sleeve is deployed to prevent the bristles
`from becoming “saturated” or wetted with moisture
`and tissue from the vaginal canal and cervical passage
`during insertion of the endometrial brush. After the
`bristles are uncovered in the endometrial cavity, the
`handle of the endometrial brush is then rotated and
`moved longitudinally to cause the bristles to “dig into”
`the endometrial walls to scrape a broad spectrum of 35
`cells and tissue therefrom. The sleeve is then deployed
`to cover the bristles, the endometrial brush is then with-
`drawn, and the sleeve is again retracted. The sample
`tissue and cells on the bristles are then wiped onto a
`microscope slide for immediate analysis. The endome-
`trial brush may be discarded or sterilized for later use.
`In one embodiment of the invention, the handle is de-
`tachable from the shaft; the shaft and bristles thereof are
`disposable.
`
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`BRIEF DESCRIPTION OF THE DRAWINGS
`
`FIG. 1 is a perspective view of one embodiment of
`endometrial brush of the invention.
`FIG. 2A is a partial view of the bristle and shaft
`portion of the endometrial brush of FIG. 1.
`FIG. 2B is a perspective view of the bristle section of
`the brush of FIGS. 1 and 2A illustrating the preferred
`helical nature of the bristle section.
`FIG. 3 is a diagram illustrating the protective sleeve
`partially deployed to cover a portion of the bristles of 55
`the endometrial brush of FIG. 1.
`FIG. 4 is a partial view of endometrial brush of FIG.
`1 showing the protective sleeve deployed to entirely
`cover the bristle section.
`
`50
`
`FIG. 5 is a sectional view taken along section lines
`5——5 of FIG. 1.
`
`60
`
`FIG. 6 is a partial sectional view taken along section
`lines 6-6 of FIG. 1.
`
`FIG. 7 is a partial sectional diagram taken along sec-
`tion lines 7—7 of FIG. 1.
`‘
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`65
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`FIG. 8 is a partial cutaway view showing an alternate
`bristle configuration for the endometrial brush of FIG.
`1.
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`4,227,537
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`4
`FIG. 9 is a partial cutaway view showing a mecha-
`nism for permitting removal of the shaft section from
`the handle section of the endometrial brush.
`FIG. 10A is a perspective view showing the configu-
`ration of the endometrial brush with the shaft bent prior
`to the utilization.
`FIG. 10B illustrates the shaft section bent with the
`sleeve deployed to cover the bristle section and form a
`seal with the end bead.
`FIG. 11A illustrates insertion of the endometrial
`brush of FIG. 10A into the cervical passage.
`FIG. 11B illustrates deployment of the endometrial
`brush of FIG. 10A bristles exposed in the endometrium.
`FIG. 12 illustrates rotation and longitudinal move-
`ment of the endometrial brush to smear the collected
`endometrial sample on a microscope slide.
`
`DESCRIPTION OF THE INVENTION
`
`Referring now to the drawings, and particularly to
`FIGS. 1-7, endometrial brush 10 includes a handle 20, a
`slidable, flexible sleeve 12 disposed about a rigid but
`bendable shaft 22, and a cylindrical, preferrably heli-
`cally wound, bristle brush 14 disposed at the end of
`shaft 22. The helically wound bristles 14 are more
`clearly illustrated in FIG. 2B. Sleeve 12 is manually
`slidable along shaft 22 to expose or cover bristles 14 by
`means of flanged disc 18, as indicated in FIGS. 1 and 7.
`The physician can slide sleeve 12 forward by using the
`thumb and first digit of his hand holding handle 20 to
`move disc 18 and sleeve 12 forward along shaft 22, as
`indicated by the arrow in FIG. 7, thereby covering
`bristles 14 and achieving a sealing relationship with
`rounded bead 16. Sleeve 12 may be made of teflon.
`Handle 20 may be molded plastic. Bristles 14 may be
`made of nylon or natural bristle, such as boar bristle.
`Bead 16 is disposed on the end of wound wire portion
`24 of shaft 22. Rounded bead 16 sealably fits within the
`interior of flexible sleeve 12 when sleeve 12 is slid for-
`ward as indicated in FIG. 4, so as to protect bristles 14
`from wetting and contamination of bristles 14 by mois-
`ture and cervical tissue during insertion of endometrial
`brush 10 through the cervix of a patient. Rounded head
`16 also prevents discomfort to the patient during the
`insertion of endometrial brush 10 through the cervix
`and into the endometrial cavity. Edge 17 of sleeve 12 is
`slightly rounded, as indicated by reference numeral 17
`in FIG. 4, to minimize discomfort to the patient during
`insertion. Rounded bead 16 may be made of plastic or
`other suitable material.
`In a presently preferred embodiment of the invention
`the outside diameters of helically wound bristle section
`14 is slightly over one fourth of an inch. The outside
`diameter of rounded bead 16 is approximately 0.125
`inches of an inch. The length of the section including '
`shaft 22 (but not any part of shaft 22 buried in handle 20)
`and bristles 14 is approximately seven inches; the length
`of bristle section 14 is approximately one inch. Handle
`20 is approximately three and one half inches long.
`However, these dimensions may be varied to suit vary-
`ing requirements.
`A wound wire shaft supporting bristles 14 is inserted
`into an open end of shaft 22, which may be composed of
`metal
`tubing having an outside diameter of approxi-
`mately 0.093 inches and an inside diameter of approxi- .
`mately 0.062 inches. FIG. 6 shows a cross-sectional
`view of flexible -sleeve 12, semi-rigid shaft 22, and
`wound wire bristle-supporting shaft 24 taken along
`section lines 6-6 of FIG. .1.
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`4,227,537
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`An alternate embodiment of the bristle section 14 is
`shown in FIG. 8, wherein a hemispherical end section
`16’ of bristles is provided at the extreme end of the
`wound wire bristle supporting shaft in place of rounded
`bead 16. The preferred helical winding of the bristles 14
`is illustrated in the perspective view of FIG. 2B. The
`embodiment of FIG. 8 may be more desirable in certain
`cases for probing the deepest portions of the endome-
`trial cavity to collect tissue and cell samples therefrom,
`but is somewhat more subject to wetting and contami-
`nation during insertion of the endometrial brush than
`the embodiment of FIGS. 1-4, and is more likely to
`cause discomfort to the patient during insertion through
`the cervix.
`
`As explained subsequently, it is desirable that shaft 22
`be semi-rigid, so that the physician can, after determin-
`ing the contour of the uterous of an individual patient,
`bend the shaft 22 so that it remains bent, as indicated in
`FIGS. 10A and 10B, to facilitate scraping of tissue from
`the desired portions of the walls of the endometrial
`cavity.
`It is anticipated that the endometrial brush 10 of the
`present invention will be most useful to physicians in
`furthering the art of diagnosing endometrial cancer if
`the endometrial brush is inexpensive and disposable,
`since the problems and inconvenience associated with
`sterilizing and cleaning the endometrial brushes after
`use is rather impractical and uneconomical in a typical
`physician’s office, where diagnosis of uterine cancer is
`ordinarily preferably made. However, FIG. 9 discloses
`an alternate embodiment of the invention having a dis-
`posable brush and shaft section and a permanent handle
`section which can be removably engaged with the dis-
`posable brush and shaft section. Alternately, the sleeve
`can be discarded and the shaft and attached bristles can
`be cleaned, sterilized, and re-used with a new sterile
`sleeve.
`
`A graded scale is preferably provided on flexible
`sleeve 12, as indicated in FIG. 1 by reference numerals
`26, 27, and 28, so that the physician can readily deter-
`mine how far endometrial brush 10 has been inserted
`into the uterine cavity before the sleeve is retracted to
`permit collecting of the tissue and cell sample. The
`graded scale eliminates the need for the physician to
`initially utilize a separate uterine sound to measure the
`uterus before deploying the endometrial brush.
`FIGS. 11A and 11B illustrate the insertion of a previ-
`ously bent endometrial brush (as indicated in FIG. 10A)
`through vagina 42 and cervix 38 into endometrial cavity
`40. FIG. 11A shows the rounded bead portion of the
`endometrial brush about to enter cervix 38; slidable
`sleeve 12 and flange disc 18 are in the forward position
`so that a moisture-proof seal is provided between the
`end of flexible sleeve 12 and rounded bead 38.
`,
`FIG. 11B shows the endometrial brush inserted into
`endometrial cavity 40 with flexible sleeve 12 and op-
`tional flanged disc l8.retracted to expose bristles 14.
`The endometrial sample is then collected.
`Referring to FIGS. 11A and 11B,
`the method of
`utilizing endometrial brush,10 to obtain accurate cyto-
`logic interpretation of the endometrium is as follows.
`First, endometrial brush 10 is removed from a sterile
`package. If a non-disposable handle is utilized, the shaft
`and brush section is connected to the handle. Protective
`sleeve 12 is then advanced over bristles 14 and rounded
`bead 16 to protect bristles 14 from wetting and contami-
`nation during insertion through the patient’s cervix 38;
`a speculum can be utilized in the usual manner.
`
`~Optio'nally, the cervix may be cleansed with an anti-
`septic solution. Endometrial brush 10 is
`inserted
`through cervic 38 into the endometrial cavity 40 until it
`reaches the fundal or top portion 48 of the uterus,
`whereat a slight resistance to further inward movement
`of brush 10 is encountered.
`The position of bristles 14 is maintained by holding
`handle 20 stationary and sliding protective sleeve 12
`along the shaft toward the handle by means of control
`disc 18, thereby exposing bristles 14 at the desired loca-
`tion within endometrial cavity 40.
`An individual patient’s cervix may be “tipped” either
`forward or backward. Semi-rigid shaft 22 of endome-
`trial brush 10 is therefore bent in accordance with the
`contour of the individual patient’s uterous so that the
`sleeve, shaft, etc., may be inserted through the cervix
`with minimum discomfort to that patient and so that
`bristles 14 will be properly positioned when the inser-
`tion of the endometrial brush is complete.
`Handle 20 is then manipulated by rotating it and
`longitudinally moving it so that the desired portions of
`the walls and fundal portion of the endometrium are
`scraped by the helical bristles 14 to collect sample tissue
`and cells therefrom.
`Endometrial brush 10 is then withdrawn straight out
`of the uterine cavity,’with the sleeve still advanced, as
`shown in FIG. 11B. In most cases, it is preferable not to
`advance sleeve 12 over the bristles 14 and rounded head
`16 prior to withdrawal of the endometrial brush 10
`because this would. scrape much of the collected cell
`and tissue sample off of bristles 14. Contamination of the
`collected cell and tissue sample by cervical cells and
`tissue during withdrawal ordinarily causes no difficulty,
`since endometrial cancer cells are usually recognizably
`different than cervical cancer cells. Since bristles 14 are
`already saturated by endometrial cells and tissue at this
`stage of the method, very few cervical cells will become
`affixed to the bristles during withdrawal through the
`— cervix. Withdrawal of the endometrial brush 10 usually
`causes very little discomfort to the patient, even with
`bristles 14 exposed.
`'
`Bristles 14 are then smeared directly on glass slide 44
`by rotating the brush and streaking it longitudinally as
`indicated in FIG. 12. This is a more convenient tech-
`nique than that described in the above Milan et al pa-
`tent, and ensures a broad spectrum of the cells and/or
`tissue collected from various parts of the endometrium
`are available on the slide 44 for analysis. Glass slide 44
`and sample 46 are then immediately placed in ninety-
`five percent alcohol fixitive and submitted for staining
`by the well-known Papanicolau technique. Further
`analysis is completely conventional, and will not be
`described herein.
`Adenocarcinoma of the endometrium is now ac-
`cepted as the most common female genital neoplasm.
`This change in relative frequency between cervical
`cancer and endometrial cancer may be attributed to
`several factors. Foremost among these factors has been
`the development of cytologic screening techniques for
`cervical cancer, widespread acceptance by physicians
`and patients of these techniques, and their wide spread
`utilization in typical doctor's offices.
`The endometrial brush 10 disclosed herein should
`permitithe significant advances in the field of cytology
`and cytotechnology to be applied to the interpretation
`of endometrial cytology by providing adequate speci-
`mens for analysis. By using the foregoing endometrial
`brush and method, endometrial specimens for analysis
`
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`7
`may be readily collected on a routine basis. The simple
`and reliable collecting technique involves minimal ex-
`pense and discomfort to the patient, and should meet
`with both physician and patient acceptance.
`The avoidance of wetting or saturation of the bristles
`of the endometrial brush of the present invention during
`insertion thereof through the cervix ensures that the
`bristles will be dry when exposed. The dry bristles can
`scrape the desired cells and tissue from the endometrial
`walls much more effectively than if the bristles are wet.
`Well established procedures which are routine in any
`gynecologist’s or obstetrician’s office are readily appli-
`cable. The inconvenience and high cost of the aspirator
`type devices and the gravely jet washer type devices
`previously used for collecting endometrial tissue and
`cell samples are overcome by the present endometrial
`brush and method of use. The helical bristles of the
`inventive endometrial brush also are believed to scrape
`cells and tissue from the endometrial walls, especially of
`the fundal portion of the endometrium, more efficiently
`than the previously described Medoza Canula, which
`has radial flanges or fins, and therefore must be moved
`forward and backward in order to collect a sample. The
`helical bristles are also believed to scrape cells from the
`endometrial walls more efficiently than the device of
`the Milan et al patent because the helical bristles indi-
`vidually dig into the endometrial walls. It is further
`believed that the wetting of the spiral section of the
`Milan et al device and the smoothness of the entire
`spiral section thereof prevent adherence of the col-
`lected endometrial sample to the degree that such ad-
`herence is achieved for the helical bristles of the present
`invention.
`
`Variations of the slidable protective sleeve are within
`the scope of the present invention. For example, the
`protective sleeve may have a closed end portion which
`is closed during insertion, and is then opened by pene-
`tration of the end of the shaft and the bristles thereon by
`sliding the protective sleeve toward the handle after
`insertion into the endometrium. In another embodiment
`of the invention, shaft 22 is flexible and sleeve 12 is
`semi-rigid. In this case, the flexible shaft 22 is rotated
`within the semi-rigid sleeve by means of the handle to
`cause the bristles to rotate inside the endometrial cavity.
`What is claimed is:
`'
`i
`
`1. An endometrial brush for obtaining endometrial
`samples, said endometrial brush comprising in combina-
`tlon:
`
`(a) a handle for manipulating said endometrial brush;
`(b) a shaft having first and second end portions, the
`first end portion being attached to said handle, said
`shaft being rigid and bendable so that when said
`shaft is bent to a particular configuration, said shaft
`rigidly retains that configuration;
`(c) a plurality of bristles attached to the second end
`portion of said shaft for collecting said endometrial
`sample, said bristles being oriented about the sec-
`ond end portion of said shaft to form a bristle sec-
`tlon;
`
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`(d) a flexible sleeve slidably disposed on said shaft for
`covering said bristles during insertion of said endo-
`metrial brush into a patient’s endometrium and
`exposing said bristles within the endometrium to
`permit scraping of cells and tissue from the endo-
`metrium by said bristles, said flexible sleeve having
`an outside diameter sufficiently small
`to enable
`insertion of said endometrial brush into the endo-
`metrium of the patient without substantial discom-
`fort to the patient;
`(e) first means connected to said sleeve for effecting
`sliding said sleeve along said shaft to cover said
`bristles during said insertion and sliding of said
`sleeve along said shaft to expose said bristles after
`said bristles are properly positioned in the endome-
`trium; and
`(f) rounded means attached to the end of said shaft for
`minimizing discomfort to the patient during inser-
`tion of said endometrial brush, wherein said sleeve
`sealably engages said rounded means if said sleeve
`is slid along said shaft so that one end of said sleeve
`slides over said bristles and over said rounded
`means, whereby no moisture, tissue, or cells con-
`tact said bristles during insertion of said endome-
`trial brush.
`2. The endometrial brush of claim 1 wherein said first
`means includes a flanged disc axially disposed on said
`shaft, said flanged disc having a disc portion which is
`easily grasped by a finger and thumb of the user of said
`endometrial brush, said flanged disc also having a flange
`portion for engaging said sleeve.
`3. The endometrial brush of claim 1 wherein said
`sleeve is composed of flexible material.
`4. The endometrial brush of claim 3 wherein said
`sleeve has a rounded edge to minimize discomfort to the
`patient during insertion of said endometrial brush.
`5. The endometrial brush of claim 1 wherein said
`handle is composed of plastic.
`6. The endometrial brush of claim 1 wherein said
`shaft is detachable from said handle.
`7. The endometrial brush of claim 1 wherein said
`shaft is composed of brass tubing.
`8. The endometrial brush of claim 1 wherein said
`bristles are supported by a wound wire shaft having an
`end thereof attached to the second end of said shaft.
`9. The endometrial brush of claim 1 wherein said
`rounded means includes a plastic head.
`10. The endometrial brush of claim 1 wherein said
`rounded means includes a metal head.
`11. The endometrial brush of claim 1 wherein said
`bristles are composed of synthetic nylon bristles.
`12. The endometrial brush of claim 1 wherein:
`(a) said bristles form a substantially cylindrical brush
`portion of said endometrial brush, said cylindrical
`brush portion having a diameter of approximately
`one fourth inch;
`(b) said sleeve has an outside diameter of approxi-
`mately 0.125 inches;
`(c) said rounded means has an outside diameter of
`approximately 0.125 inches.
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