Classifications

• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B10/00—Other 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
  • A61B10/02—Instruments for taking cell samples or for biopsy
  • A61B10/0291—Instruments for taking cell samples or for biopsy for uterus
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B10/00—Other 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
  • A61B10/0045—Devices for taking samples of body liquids
  • A61B2010/0074—Vaginal or cervical secretions

Definitions

• 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 cervix.
• 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.
• Once the sample has been taken, at least a proportion of the cells collected on the sampler are transferred to a glass optical slide for subsequent examination under a suitable microscope, in an attempt to ascertain the cancer status of the cervix. This procedure is well known and understood by those skilled in the art, and so will not be described in more detail here.
• sampling device is formed from wood and incorporates a sampling head corresponding generally to the cross sectional surface profile of the cervix.
• sampling head corresponding generally to the cross sectional surface profile of the cervix.
• Such "spatula" type devices are excessively rigid, and so are not well adapted to properly accommodate the wide variations in size and shape of cervix which are routinely encountered.
• the effective area of coverage during the sampling procedure is relatively small. This in turn can lead to inaccurate diagnosis, and can also cause excessive 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.
• the cancer cells and dysplastic cells are often damaged or deformed during 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 of poor coverage and inadequate sample transfer, this reduces even further the accuracy of the pap smear test in terms of its ability to provide a reliable indication of cervical cancer.
• the invention provides 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.
• 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.
• 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.
• the device includes a relatively flexible joint disposed intermediate the handle and the sampling head to permit a degree of relative axial movement therebetween.
• a relatively flexible joint disposed intermediate the handle and the sampling head to permit a degree of relative axial movement therebetween. This enables effective rotation and manipulation of the device with the handle inclined at an oblique angle with respect to the head.
• the flexible joint is conveniently provided by an intermediate neck region of reduced cross sectional area immediately adjacent the sampling head.
• the sampling head is formed substantially from a suitable elastomeric material such as rubber, santoprene, silicon, flexible polyurethane, or the like.
• the sampling head includes a second support arm effectively interconnected with the first, and extending axially within the probing stem to facilitate insertion into and location 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 flexible web.
• the support arms may be integrally moulded within a surrounding elastomeric portion, to form a composite sampling head of unitary construction.
• the sampler is formed 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.
• Figure 1 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 1;
• Figure 3 is a diagrammatic side elevation showing the device of Figure 1 in position ready for use adjacent a cervix;
• Figure 4 is a side elevation similar to Figure 1 showing the sampling head of a second embodiment of the invention.
• Figure 5 shows a third embodiment of the invention
• Figure 6 shows a fourth embodiment
• Figure 7 is a front elevation showing a further 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 wiping blade and the support arm;
• Figure 9 shows an alternative form of flexible neck disposed intermediate the sampling head and the handle.
• the invention provides a pap smear sampling device 1 for use in the detection of cancer cells in the female cervix 2 in accordance with the established gynaecological "pap smear" testing procedure well,known and understood by 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 cervix.
• the sampling head 5 comprises a relatively firm probing stem 10 extending generally axially from the handle 6 for insertion into the cervix to collect sample cells from the endocervix 12.
• the sampling head further includes a first outwardly extending relatively rigid support arm 13 formed from spring steel wire, plastics or other suitable material.
• a relatively soft flexible web 14 extends intermediate the stem 10 and the remote end of the first support arm 13 to define a flexible wiping blade 15 adapted to scrape and collect sample cells from the ectocervix 16.
• the flexibility of the web 14 enables the marginal edge of the wiping blade 15 flexibly to conform closely to the complex surface contours of the ectocervix, whilst the relatively rigid support provided by first arm 13 enables an effective scraping angle relative to the cervix to be maintained, upon rotation and manipulation of the device.
• the sampling 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 the cervix .
• the stem 10 includes a longitudinally extending 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 endocervix by the rib, upon withdrawal of the sampling device.
• the handle 6 immediately adjacent the sampling head includes a neck region of reduced cross-sectional area forming a flexible "universal" joint 25.
• the joint 25 permits a limited degree of relative movement and axial misalignment between 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 flexible joint are also envisaged.
• the relatively soft and flexible portion of the sampling head including the probing stem and transverse web is preferably moulded from a suitable elastomeric material such as rubber, santoprene, silicone, flexible polyurethane, polypropylene, polyethylene or the like.
• the support arms 13 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.
• a second embodiment of the invention is shown in Figure 4, wherein corresponding features are denoted by corresponding reference numerals. In this embodiment, the central and lower portion of the web 14 is removed, effectively to define cut-out region 27.
• 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 fixedly connected with the handle.
• the design provides for the substitution of interchangeable elastomeric head portions 28 of different size, shape, or resiliency, to suit . particular applications.
• a range of interchangeable elastomeric head portions can be provided to enable the sampling device to be tailored to suit individual patients' requirements.
• a third embodiment of the invention is shown in Figure 5, where again, corresponding features are denoted by corresponding reference numerals.
• 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 captively retained within a complementary socket formed in the handle (not shown) .
• Figures 7 and 8 show a fourth embodiment of the invention.
• the entire sampler is formed from a single suitably flexible material such as polyethylene, or polypropylene as a one piece moulding.
• the wiping blade 15 and associated support arm 13 which, as best seen in Figure 8, is achieved by a difference in material thickness rather than material type.
• the web portion 14 defining the scraping blade is relatively thin and correspondingly flexible, thereby enabling it to resiliently deform to accommodate irregularities in the surface profile of the ectocervix during sampling.
• the support portion 13 is relatively thick in transverse cross section particularly adjacent its base, thereby to provide a relatively rigid support for the remote end of the wiping blade.
• cut-out region 27 is provided to enhance flexibility of the wiping blade and economise on material. It should be appreciated, however, that this portion could be "filled-in” so as to form a gusset extending between the remote end of the wiping blade and the base of the sampling head. This would function in a mechanically 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 flexible operative edge of the scraping blade. Further, the endocervical probe portion does not incorporate discrete ribs and channels, but rather has a simple rectangular cross-sectional configuration, which has also been found to be effective in collecting cells from the endocervix.
• This embodiment also incorporates an additional sampling member 35 disposed on the terminal end of the handle remote from the head, for use in applications not requiring penetration of the probing stem.
• the. operative edge of the wiping blade is adapted to curve 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 remote tip of the operative edge of the wiping blade intersects a projected axis of the stem and handle at an included angle of between around 0° to 90°, and preferably around 40°. This extent of curvature ensures adequate coverage of the ectocervix, and is only able to be effectively achieved by virtue of the support afforded to the remote end of the wiping blade by the support portion.
• the sampling device is first positioned in the conventional manner and the probing stem 10 inserted into the cervix, thereby radially locating the sampling head.
• the device is then manually rotated by the handle (in either the clockwise or anticlockwise direction).
• the endocervix is scraped by longitudinal rib 20 whereby sample cells are collected and retained within the recessed channels 21.
• the endocervical cells are simply retained on the flat faces of the probe.
• the wiping blade 15 defined by flexible web portion 14 scrapes the entire outer surface of the ectocervix, whereby sample cells are collected and retained on the frontal surface of the web.
• the wiping blade flexibly and progressively conforms to the complex profiles of the cervix, including any surface irregularities.
• 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 flexibility of the web intermediate the support portion and stem maximises the effective sampling area, whilst minimising contact bleeding and patient discomfort.
• the device is withdrawn.
• the samples from the stem 10 and web 14, containing cells collected from the endocervix and ectocervix respectively, are then transferred by a simple wiping action onto an appropriate optical slide for subsequent analysis and testing in accordance with established diagnostic, procedures.
• the web 14 may include a series of spaced apart slits extending 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 enhance the ability of the wiping blade to conform closely to irregular surface contours of the cervix, whilst still providing excellent coverage over substantially the entire outer surface of the cervix and substantially complete transferability of the sample to a slide.
• 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 ectocervix than flexible prior art samplers, and still support sufficient scraping pressure to consistently recover a complete sample. Furthermore, the device according to the present invention enables virtually complete transfer of the collected sample to a microscope slide for subsequent analysis.
• the flexible 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 cervix, despite relative axial misalignment of the handle within a reasonably broad range of tolerance.
• the improved configuration and flexibility of the sampling head thus enables the device to accommodate a wide variation in cervix size and shape, whilst affording precise control and minimising pain, discomfort > bleeding, and cell damage .
• the likelihood of inaccurate diagnosis of the cancer status of the cervix is significantly 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 cervix samples to be taken simultaneously, and subsequently isolated on separate slides 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 approximately correlated to a corresponding position on the surface of the cervix, 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 meaningful 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.
• the probe need not incorporate a longitudinally extending rib and channel as described, but may incorporate a series of longitudinal ridges, recessed grooves, surface dimples, or be of any other suitable non-circular cross-sectional profile.

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• 1992
  • 1992-07-17 EP EP92916556A patent/EP0594786A4/de not_active Withdrawn
  • 1992-07-17 JP JP5501162A patent/JPH06509003A/ja active Pending
  • 1992-07-17 WO PCT/AU1992/000367 patent/WO1993001749A1/en not_active Application Discontinuation
  • 1992-07-17 CA CA002113088A patent/CA2113088A1/en not_active Abandoned

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