CA2113088A1 - Pap smear sampling device - Google Patents

Pap smear sampling device

Info

Publication number
CA2113088A1
CA2113088A1 CA002113088A CA2113088A CA2113088A1 CA 2113088 A1 CA2113088 A1 CA 2113088A1 CA 002113088 A CA002113088 A CA 002113088A CA 2113088 A CA2113088 A CA 2113088A CA 2113088 A1 CA2113088 A1 CA 2113088A1
Authority
CA
Canada
Prior art keywords
sampling device
sampling
stem
head
handle
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Abandoned
Application number
CA002113088A
Other languages
French (fr)
Inventor
Henry Martin Stenning
Sidney Londish
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
LONSTEN Pty Ltd
Original Assignee
Individual
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Individual filed Critical Individual
Publication of CA2113088A1 publication Critical patent/CA2113088A1/en
Abandoned legal-status Critical Current

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B10/00Other methods or instruments for diagnosis, e.g. instruments for taking a cell sample, for biopsy, for vaccination diagnosis; Sex determination; Ovulation-period determination; Throat striking implements
    • A61B10/02Instruments for taking cell samples or for biopsy
    • A61B10/0291Instruments for taking cell samples or for biopsy for uterus
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B10/00Other methods or instruments for diagnosis, e.g. instruments for taking a cell sample, for biopsy, for vaccination diagnosis; Sex determination; Ovulation-period determination; Throat striking implements
    • A61B10/0045Devices for taking samples of body liquids
    • A61B2010/0074Vaginal or cervical secretions

Abstract

A pap smear sampling device (1) for use in the detection of cancer cells in the female cervix (2), said device including a sampling head (5) adapted to engage and scrape the surface of the cervix for collection of sample cells. An elongate handle (6) permits remote rotation and manipulation of the sampling head, which further comprises a probing stem (10) extending generally axially from the handle for insertion into the cervix to collect sample cells from the endocervix. A relatively rigid support portion (13) extends outwardly from the handle or the stem, and a relatively flexible web portion (14) extends generally intermediate the stem and the support portion to define a flexible wiping blade (15) adapted to scrape and collect sample cells from the ectocervix. The blade (15) is adapted flexibly to conform closely to the surface contours of the ectocervix, whilst maintaining an effective scraping angle upon said rotation and manipulation of the sampling head.

Description

2~1 30~
WO ~3/01749 PCr/AU92/00367 Title: PAP SMEAR SAMPLING DEVICE~ .

TECHNICAL FIELD ~:
The present invention relates to pap smear sampling devices of the type used in the gynaecological field for the detection of cancer cells in the female cervi~.
BACKGROUND ART
A number of sampling devices have hitherto been ~-available to conduct these so-called "pap smear" tests.
Such devices are generally adapted to be inserted into ~:
the cervix and then rotated so as to wipe or scrape the ;
surface of the cervix, in an attempt to collect and retain sample cells. Oncs the sample has been taken, at least a proportion of the cells collected on the sampler are-tr~ans~erred to a ~lass optical slide for subsequent examination under a suitable microscope, in an attempt to ascertain ths cancer status of the cervix. This procedure is well known and understood by those skilled 21133~

in the art, and so will not be described in more detail her It has been found in practice, however, that known pap smear samplin~ devices are inadequate in a number of significant respects. It has been shown statistically that the accuracy of cervical cancer detection is relatively low, and many cases go undetected in the early stages, largely as a result of the inefficiency of the pap smear sampling devices curr~ntly in use.
One known type of sampling de~ice is formed from wood and incorporates a sampling head corresponding generally to the cross sectional surface profile of the cervi~. However, such ~spatula~ type devices are e~cessively rigid, and so are not well ada~ted to properly accommodate the wide variations in size and shape of cervi~ which are routinely encountered.
Moreover, because of the inability of these rigid spatulas to conform flexibility to the relatively comple~ and Yaried surface contours of the cervi~, the e~fective area of coverage during the sampling procedure is relatively small. This in turn can lead to inaccurate diagnosis, and can also cause e~cessive pain and discomfort to the patient. The spatula type samplers also have a tendency to cause contact bleeding, which makes detection of cancer cells amongst the .interspersed red blood cells considerably more difficult and less accurate.

. WO93/01749 211 3 ~ 8 ~ PCT/AU92/00367 In an attempt to ameliorate these problems, a number of prior art devices have incorporated various configurations of bristles, fibres, filaments or brushes, which are generally mounted on a support arm or wire. However, these ~br~sh" type devices can also cause substantial pain and bleeding, as well as damage to the cervical sample, particularly if suffi~ient care is not taken during the sampling procedure. Such . samplers do tend to:give better surface coverage than the rigid spatula type devices discussed above, by virtue of the fact that the bristles can resiliently deform to a certain e~tent, thereby enabling the brush --to conform more closely to the surface contours of the ~:
cervi~. However, these devices still cannot provide complete coverage, and in addition suffer the inherent problem of poor transfer- ability of the collected sample to the microscope slide for subsequent analysis.
This is largely because the sample cells tend to remain trapped in the intersticial voids between the bristles within the inner confines of the brush, and are therefore not readily accessible and transferable to the ælides. A~ain, this leads to inaccurate diagnosis, particularly in the critical preliminary stages of cervical cancer.
Moreover, with both the major types o known samplers discussed above, the cancer cells and dysplastic cells are often damaged or de~ormed during 2 ~
WO93/01749 ; PCT/AU92/0036 the sampling procedure, and so become more difficult to detect accurately with known diagnostic techniques.
Combined with the inherent inadequacies of the sampling devices in terms o~ poor coverage and inadequate sample transfer, this reduces even ~urther the accuracy of the pap smear test in terms of its ability to provide a reliable indication of cervical cancer.
Finally, many known sampling-devi~es tend not to be able to diff~rentiate::ef ectively`between the inside and outside sample areas of the cervi~; and so are not effective in isolating sample cells collected from the endocervi~ and ectocervi~ respectively, which is also important for accurate diagnosis.
It is therefore an object of the present invention to provide an improved pap smear sampling device which overcomes or substantially ameliorates at least some of the disadvantages of the prior art.
DISC~OSURE OF THE INVENTION
Accordingly, the invention provides a pap smear sampling device for use in the detectiQn of cancer cells in the female cervi~, said device including a sampling head adapted to engage and scrape the surface of the cerYi~ for collection of sample cells, and an elongate handle~to permit remote rotation and manipulation of the sampling head, said sampling head comprising a probiny stem e~tending generally axially from the handle for insertion into the cervi~ to collect sample cells from WO ~/0174~ 3 ~ g ~ PCT/AV92/00367 the endocervix, a relatively rigid support portion e~tending outwardly from the handle or the stem, and a relatively flexible web portion e~tending generally intermediate the stem and the support portion to define a fle~ible wiping blade adapted to scrape and collect sample cells from the ectocervi~, said ~lade being :
adapted fle~ibly to conform closely to the surface contours of the ectocervi~,-~hilst maintaining an .effective scraping angle upon said rotation and: ~-manipulation of-the sampling head.~
Preferably, the probing stem includes at least one longitudinally extending rib adapted rotatingly to scrape sample cells from the endocervix, and at least one corresponding longitudinally extending recessed channel or groove disposed adjacent the rib to retain the sample cells scraped from the endocervix by the rib. In another embodiment, the stem takes the form of a relatively flat narrow blade generally rectangular in transverse cross section, in which case the sample is simply retained on the flat faces of the stem.
Pre$erably also, the device includes a relatively fle~ible joint disposed intermediate the handle and the sampling head to permit a degree of relative a~ial movem~nt therebetween.. This enables effectiv~ rotation and manipulation of the device with the handle inclined at an oblique angle with respect to the head~ In the preferred embodiment, the fle~ible joint is conveniently 211308~
WO93/01749 PCT/AU~2/0036 provided by an intermediate neck region of reduced cross sectional area immediately adjacent the sampling head.
Preferably also, the sampling head is formed substantially from a suitable elastomeric material such as rubber, santoprene, silicon, flexible polyurethane, or the like.
In one embodiment, the sampling head includes a .second support arm effectively interconnected with the first, and e~tending asially within the probing stem to facilitate insertion into and-loca~ion within the cervix. The first and second support arms are preferably formed from spring steel wire or plastic, and are connected to the handle for releasable detachment from a separate elastomeric portion of the sampling head incorporating the fle~ible web. In other embodiments, the support arms may be integrally moulded within a surrounding elastomeric portion, to form a composite sampling head of unitary construction.
In the preferred embodiment, however, the sampler is fsrmed from one type of material in a single moulding and the difference in flexibility between the wiping blade and the support portion is achieved by an appropriate variation in material thickness.
BRIEF DÉSCRIPTIO~ OF DRAWINGS
Preferred embodiments of the invention will now be described, by way of ezample only, with reference to the accompany drawings in which:

WO93/01749 21 1 3 0 8 ~ PCT/AU92/00367 Figure l is a side elevation showing a first ~:
embodiment of a pap smear sampling device according to the invention;
Figure 2 is a cross-sectional view taken along line ~.
- 2~2 of Figure l;
Figure 3 is a diagrammatic side elevation showing the device of Figure l in position ready for use adjacent a cervis; . - ~
. ~^.- ~Figure 4 is-~a side elevation similar:,to~sFigure l showing the sampling head of a second embodiment of the invention;
Figure 5 shows a third embodiment of the invention;
Fîgure 6 shows a fourth embodiment;
Figure 7 is a front elevation showing a furthsr embodiment of the invention, formed from a single material;
Figure 8 is a side elevation of the sampler of Figure 7 showing the variation in thickness between the wipin~ blade and the support arm; and Figure 9 shows an alternative form of flesible neck disposed intermediate the sampling haad and th~ handle.
BEST M~DE FOR CARRYING OUT THE INVENTION
Referring firstly to Figures l to 3, the invention provldes a pap smear s.ampling device l for use in the detection of cancer cells in the female cer~ig 2 in accordance with the established gynaecological "pap smear~ testing procedure well known and understood by 2l~3ns~ . .
WO93/01749 ' PCT/AU92/0036;~.

those skilled in the art. The sampling device includes a sampling head 5 adapted to engage and scrape the surface of the cervix for collection of sample cells, and an elongate handle 6 to permit remote rotation and - manipulation of the sampling head when engaged with the cervi~. -The sampling head 5 comprises a relatively firmprobing stem 10 e~tending generally a~ially from the ~ handle 6 for insertion into':the`'cervix'to'`collect sample - - cells from the endocervi~ l2. The-sampling head further ,încludes a irst outwardly e~tending relatively rigid support arm 13 formed from sprin~ steel wire, plastics or other suitab~e makerial. A relatively soft fle~ible web 14 e~tends intermediate the stem 10 and the remote end of the first support arm 13 to define a ~lexible wiping blade 15 adapted to scrape and collect sample c811s from the ectocervix 16. The flexibility of the web 14 ena~les the marginal edge of the wiping blade 15 1esibly to conform closely to the complex surface contours of the ectocervix, whilst the relatively rigid support provided by first arm 13 enables an effective æcraping angle relative,to the cervix to ~e maintained, upon rotation and manipulation of the device. The sampllng head preferably includes a second support arm 17 interconnected with the first arm 13 to provide relatively rigid internal support for the stem, thereby facilitating insertion into and positive location within WO93/01749 211 3 0 8 ~ PCT/AV92/00367 the cervi~.
The stem 10 includes a longitudinally e~tending protruding rib 20 adapted to scrape the endocervix upon rotation of the sampling head, and a pair of corresponding longitudinally extending recessed channels 21 disposed on either side of the rib to retain the sample cells scraped from the endocervi~ by the rib, upon~withdrawal of the sampling device.~;~
The handle 6 immediately adjacen~f-the~sampling head includes a neck re~ion of reduced cross-sectional area forming a fle~ible Uuniversal~ joint 25. The joint 25 permits a Iimited degree of relative movement and a~ial misalignment ~etween the handle and the sampling head.
This facility enables effective rotation and manipulation of the sampling head with the handle inclined at an angle with respect thereto. Other forms of fle~ible joint are also envisaged.
In the embodiment of Figures 1 to 3, the relatively soft and 1esible portion of the sampling head including the probing stem and transverse web is preferably moulded from a suitable elastomeric material such as rubber, santoprene, si1icone, flesible polyurethane, polypropylene, polyethylene or the like. The support arms~l~ and 17 are preferable formed from spring steel wire, although it will be appreciated that any suitably - firm or relatively rigid metal, plastics, polymer, wood or other material can also be used.

2~13~8~
WOg3/01749 PCT/AU92/0036, A second embodiment of the invention is shown in Figure 4, wherein corresponding features are denoted by corresponding reference numerals. In this embodimen~, the central and lower portion o the web 14 is removed, effectively to define cut-out region 27. This configuration provides greater flexibility for the wiping blade 15, and thereby reduces the a~ial force required or the blade to conform closely-lto the comple~
outer surface contours-of the ectocervi~ during the sampling procedure. This configuration also saves on material costs. It should be appreciated, however, that in this embodiment, the transverse web 14 is still provided with sufficient frontal area to retain the collected cell sample, below the operative marginal edge of the wiping blade. A similar form of the invention is shown in Figure 6.
In the embodiments of Figures 1, 4 and 6, the elastomeric portion 28 of the sampling head is formed in a separate moulding step, and is releasably detachable from the complementary support arms 13 and 17 which are fi~edly connected with the handle. In this way, the design provides for the substitution of interchangeable elastomeric head portions 28 of different size, shape, or res~liency, to suit par~icular applications. Thus, a range of interchangeable elastomeric head portions can be provided to enable the sampling device to be tailored to suit individual patients' requirements.

,. , 211308~

A third embodiment of the invention is shown in Figure 5, where again, corresponding features are denoted by corresponding reference numerals. In this embodiment, the elastomeric material is actually moulded around an internal wire support frame, consisting essentially of the first and second support arms 13 and 17. The composite sampling head is then attached as a unitary structure to a complementary handle by means of -~ elastomeric boss portion 30, which is captivsly retained within a complementary socket formed in the handle (not shown3.
Figures 7 and 8 show a fourth embodiment of the invention. In this case, there is no separate suppsrt frame formed from spring steel wire or other material.
Rather, the entire sampler is formed from a single suitably flexible material such as polyethylene, or polypropylene as a one piece moulding. There is, however, still a difference in relative flexibility between the wiping blade 15 and associated support arm 13 which, as best seen in Figure 8, îs achieved by a difference in material thickness rather than material type. More particularly, the web portion 14 defining the scraping blade is relatiYely thin and correspondingly flexible, thereby ena~ling it to resiliently deform to accommodate irregularities in the surface profile of the ectocervix during sampling. ~n the other hand, the support portion 13 is relatively 211 ~8~ `
WO93/0174g - PCT~AU~2/0036 thick in transverse cross section particularly adjacent its base, thereby to provide a relatively rigid support for the remote end of the wîping blade.
In this embodiment, cut-out region 27 is provided - to enhance flexibility of the wipin~ blade and economise on material. It should be appreciated, however, that this portion could be Yfilled-in~ so as to form a gusset extending between the remote end of the wipinq blade and .~ . the ba~e of..the sampling head. This would function in a mecha~ically analogous way. However, instead of a discrete support arm separate from the web, there is simply a smooth transition from the relatively thick support section of the gusset adjacent the base of the sampling head, to the relatively thin and flesible operative edge of the scrapin~ ~lade. Further, the endocervical probe portion does not incorporate discrete ribs and channels, but rather has a simple recta~gular cross-sectional configuration, which has also been found to be effective in collectin~ cells from the endocervix.
This embodiment also incorporates an additional sampl ing ~ember 35 disposed on the terminal end of the handle re~ote from the head, for use in applications not requiring penetration of the probing stem.
-In each case, the operative edge of the wiping blade is adapted to curvs through an angle of between around 90 to 180-and preferably around 140 from the stem. That is to say, a tangent projected from the 21 1308~
WO93J0174~ PCT/AU92/00367 r~mote tip of the operative edge of the wiping blade intersects a projected a~is of the stem and handle at an included angle of between around 0 to 90, and prefera~ly around 40~. This e~tent of curvature ensures adequate coverage of the ectocervi~, and is only able to be effectively achieved by virtue of the support afforded to the remote end of the wiping blade by the ~upport portion.
Turning now to:describ~:briefly the method of use, the sampling device is first positioned in the conventional manner and the probing stem lO inserted into the cervis, thereby radially locating the sampling hsad. The device is then manually rotated by the handle (in either the clockwise or anticlockwise direction~.
I~ this way, the endocervix is scraped by longitudinal rib 20 whereby sample cells are collected and retained within the recessed channels 21. In the case of the embodiment of Figures 7 and 8, the endocervical cells are simply retained on the flat faces of the probe.
Simultaneously, the wiping blade lS defined b~ fle~ible web portion l~ scrapes the entire outer surface of the ectocervis, whsreby sample cells are collected and retainsd on the frontal surface of the web. During this opera~on, as a result.of asial pressure applied by the operator, the wiping blade flexibly and progressively conforms to the complex profiles of the cervi~, including any surface irregularities. At the same time,-8 ~
WO93/01749 PCT/AU~2/~036 the support arm or section 13 maintains an effective scraping angle over the entire cervix by providing support for the end of the wiping blade remote from the stem and thereby permitting substantially uniform pressure distribution across the blade. In this way, sample cells are recovered from substantially the entire outer surface of the cervix. It will be appreciated that the relative flesibility of the web intermediate the~support portion and stem ma~imises the effective sampling-~area, whilst minimising contact bleeding and patient discomfort. This is in contrast with prior art devices, which have generally been unable to eff2ctively wipe the entire ectocervi~, because of the lack of fle~ible form-fitting capability and/or the lack of support for the remot~ end of the wiping which prevents sufficient pressure to be applied uniformly across its operative edge.
Once the sampling procedure has been completed, the device is withdrawn. The samples from the stem 10 and web 14, containing cells collected from the endo~erYi~
and ectocervix respectively, are then transferred by a simple wiping action onto an appropriate optical slide for subsequent analysis and testing in accordance with estabr~shed diagnostic procedures.
During transfer of the sample from the stem to the slide, in the embodiments shown in Figures 1 to 6, sufficient wiping pressure is applied against the slide WO93/01749 21~ 3 0 ~ ~ PCT/AU92/00367 to fold back the rib 20 so that the full sample retained within-the channels 21 is exposed and progressively transferred by the wiping action onto the slide.
Similarly, a simple wiping action is sufficient to transfer the entire sample from the frontal face of the web 14 to the slide. This operation is also facilitated by the support afforded to the web by the support portion 13. Consequently, substantially the entire sample is available~for-analysis. ~
. In other embodiments (not shown), the web l4 may include a series of spaced apart slits estending generally parallel to the stem, whereby the marginal edge of the wiping blade 15 is still effectively continuous, but defined by a series of complementary wiping ~fingers~. It is envisaged that this will further enhan~e the ability of the wiping blade to conform closely to irregular surface contours of the cervi2, whilst still providing excellent coverage over substantially the entire outer surface of the cervix and gubstantially ~omplete transferability of the sample to a slide.
It will be apparent that the present invention provides a number of significant advantages over the prior ~art. Firstly, as a result of its inherent ~form-fitting" capability, the effective area of coverage during the sampling procedure for a given length of wiping blade is greatly increased, . , , , ~ .

particularly when compared with the rigid prior art "spatula" type devices. Moreover, the support provided for the remote end of the wiping blade enables it to wrap further around the ectocervi2 than fle~ible prior - art samplers, and still support sufficient scraping pressure to consistently recover a complet~ sample.
Furthermore, the device according to the present invention enables virtually complete transfer of the collected sample to a microscope slide for subseguent analysis. There is no possibility of sample cells remaining trapped in intersticial voids between bristles fibres, or filaments as occurs with prior art ~brush"
type devices. As previously mentioned, on a ststistical basis this significantly reduces the probability of ~:`
inaccurate diagnosis. Additionally, the fle~ible joint provided intermediate the sampling head and the handle enables the device to accommodate a significant degree of operator error, by virtue of the fact that the sampling head is adapted automatically to assume the optimum position around the cervi~, despite relative a~ial misalignment of the handle within a reasonably broad range of tolerance.
The improved configuration and fle~ibility of the sampl-lng head thus enables the device to accommodate a wide variation in cervix size and shape, whilst affording precise control and minimising pain, discomfort, blesding, and cell.damage. By reducing WO93/01749 21 1 3 ~ ~ ~ PCT/AU92/00367 contact bleeding and cell damage, the likelihood of inaccurate diagnosis of the cancer status of the cervix is siqnificantly reduced. Sampling time is also significantly reduced because the device is able to provide an effective and accurate "first time" sample.
The accuracy and specificity of the diagnosis is further enhanced by enabling distinct inside and outside cervi~ samples to be taken simultaneously, and subsequently isolated on separate slide~ for individual analysis if required. More particularly, because the sample is transferable by a straight wiping action, the relative transverse position of any cancer cells detected on the slide can be appro~imately correlated to a correspondi~g position on the surface of the cervi~, ~
thereby providing a relatively accurate target zone for ~.
subsequent testing. This is in contrast with prior art sampling devices, which require the sample to be transferred to a slide by a random brushing, scraping or spreading action which effectively destroys any ~eaningful correlation between the relative positions of sample cells on the slide. Thus, it will be apparent that the present invention represents a commercially significant improvement over the prior art.
Although the invention has been described ~ith reference to specific e~amples, it will be appreciated by those skilled in the art that the invention may be embodied in many other forms., For e~ample, the probe wo 932,ol7193 0 8 ~ Pcr/Aug2/on36l need not incorporate a lonyitudinally extending rib and channel as described, but may incorporate a series of longitudinal ridges, recessed grooves, surface dimples, or be of any other suitabls non-circular cross-sectional - profile.

.~ .

Claims (23)

CLAIMS:-
1. A pap smear sampling device for use in the detection of cancer cells in the female cervix, said device including a sampling head adapted to engage and scrape the surface of the cervix for collection of sample cells, and an elongate handle to permit remote rotation and manipulation of the sampling head, said sampling head comprising a probing stem extending generally axially from the handle for insertion into the cervix to collect sample cells from the endocervix, a relatively rigid support portion extending outwardly from the handle or the stem, and a relatively flexible web portion extending generally intermediate the stem and the support portion to define a flexible wiping blade adapted to scrape and collect sample cells from the ectocervix, said blade being adapted flexibly to conform closely to the surface contours of the ectocervix, whilst maintaining an effective scraping angle upon said rotation and manipulation of the sampling head.
2. A sampling device according to claim 1 wherein said wiping blade defines a substantially smooth effectively continuous operative edge adapted for engagement with the ectocervix.
3, A sampling device according to claim 1 or claim 2 wherein the wiping blade includes a series of spaced apart slits extending generally parallel to the stem to define a corresponding plurality of wiping fingers.
4. A sampling device according to any one of the preceding claims wherein the support portion comprises a first support arm, and further including a second support arm effectively interconnected with the first, the second support arm extending axially within the stem.
5. A sampling device according to claim 4 wherein the first and second support arms support a separate elastomeric head portion incorporating the flexible web.
6. A sampling device according to claim 5 wherein the elastomeric head portion incorporating the flexible web is interchangeable with corresponding head portions of different size, shape, or material properties to suit particular applications.
7. A sampling device according to claim 4 wherein the support arms are integrally moulded within a surrounding elastomeric head portion incorporating the flexible web, to form a composite sampling head of unitary construction.
8. A sampling device according to any one of claims 4 to 7 wherein the support arms are formed from a metallic wire and the surrounding elastomeric head portion is formed from a suitable plastics material or rubber.
9. A sampling device according to any one of claims 1 to 7, wherein the sampling head is formed substantially from a single type of material and wherein the difference in flexibility between the wiping blade and the support portion is achieved by an appropriate variation in material shape, configuration, thickness or cross sectional area.
10. A sampling device according to claim 9, formed from a singled material in a one-piece moulding.
11. A sampling device according to any one of the preceding claims, wherein the sampling head incorporates a cut-out region disposed generally intermediate the wiping blade and the support portion.
12. A sampling device according to any one of claims 1 to 10 wherein the region generally intermediate the wiping blade, the support portion and the stem is filled-in with additional support material to form a support gusset for the wiping blade.
13. A sampling device according to any one of the preceding claims, wherein the stem includes at least one longitudinally extending rib adapted rotatingly to scrape sample cells from the endocervix.
14. A sampling device according to claim 13, wherein the stem further includes at least one corresponding longitudinally extending channel or groove disposed adjacent the rib to retain sample cells scraped from the endocervix.
15. A sampling device according to any one of the preceding claims, wherein the stem is generally flat, and substantially rectangular in transverse cross section.
16. A sampling device according to any one of the preceding claims, further including a relatively flexible joint disposed intermediate the handle and the sampling head to accommodate a degree of relative axial misalignment therebetween, and thereby enable effective rotation and manipulation of the device with the handle inclined at an oblique angle with respect to the head.
17. A sampling device according to claim 16 wherein the flexible joint is defined by an intermediate neck region of reduced cross-sectional area, providing increased flexibility relative to the handle and the head.
18. A sampling device according to claim 16 or 17 wherein the sampling head is adapted automatically to tend to assume an optimum orientation for scraping around the cervix, within a limited range of relative axial misalignment with respect to the handle.
19. A sampling device according to any one of the preceding claims, further including an additional sampling member disposed on the terminal end of the handle remote from the head, the additional sampling member being adapted to scrape sample cells from the ectocervix, in applications not requiring penetration of the endocervix by the probing stem.
20. A sampling device according to any one of the preceding claims wherein the wiping blade is adapted to extend around substantially the entire outer surface of the ectocervix.
21. A sampling device according to claim 19 wherein the remote edge of the wiping blade is inclined tangentially at an angle of between around 0° to 90° to a generally longitudinal axis of the handle and the probing stem.
22. A sampling device according to claim 21 wherein the remote end of the wiping blade is inclined tangentially at an angle of around 40°.
23. A sampling device according to any one of the preceding claims, formed from a suitable material selected from the group comprising rubber, santoprene, silicon, polyurethane, polyethylene, and polypropylene.
CA002113088A 1991-07-17 1992-07-17 Pap smear sampling device Abandoned CA2113088A1 (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
AUPK7276 1991-07-17
AUPK727691 1991-07-17

Publications (1)

Publication Number Publication Date
CA2113088A1 true CA2113088A1 (en) 1993-02-04

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Application Number Title Priority Date Filing Date
CA002113088A Abandoned CA2113088A1 (en) 1991-07-17 1992-07-17 Pap smear sampling device

Country Status (4)

Country Link
EP (1) EP0594786A4 (en)
JP (1) JPH06509003A (en)
CA (1) CA2113088A1 (en)
WO (1) WO1993001749A1 (en)

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AT392411B (en) * 1988-07-20 1991-03-25 Maria Dr Hengstberger Device for taking up and giving up cell material, in particular for a gynaecological cancer smear
NL9000166A (en) * 1990-01-23 1991-08-16 Futurerole Ltd DEVICE FOR SIMULTANEOUS SAMPLING OF BOTH THE ENDOCERVIX AND THE EXOCERVIX, WHICH APPARATUS IS ONE PIECE AND EQUIPPED WITH A STEEL, OF WHICH A END BEARS A SCRAPER.
US5022408A (en) * 1990-04-23 1991-06-11 Mohajer Reza S Combination exo/endocervical sampler
SE465451B (en) * 1990-05-10 1991-09-16 Medscand Ab INSTRUMENTS FOR ENDO- AND ECTOCERVIC SAMPLING

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WO1993001749A1 (en) 1993-02-04
JPH06509003A (en) 1994-10-13
EP0594786A1 (en) 1994-05-04
EP0594786A4 (en) 1995-02-22

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