AU2003202307B2 - Vaginal speculum with sealing element - Google Patents

Description

WO 03/065885 PCT/AU03/00117 VAGINAL SPECULUM WITH SEALING ELEMENT Technical field This invention relates to vaginal speculums used for at least the examination of at least the cervical area of the vagina. Essentially such speculums comprise a tubular probe able to be inserted into the vaginal barrel through the vaginal orifice, to define a line of sight extending through the orifice, and associated external equipment.

Background Art As is well known the examination may be made by the naked eye or by means of an optical or electronic camera.

As is also well known, preferred embodiments of vaginal speculums may also provide access to the interior of the vaginal barrel for surgical instruments, such as for example, tissue samplers for collecting cells for so called pap smear tests as used to detect the onset of cervical cancer.

To facilitate examination of the cervical area and the operation of such instruments it has been suggested that vaginal speculums should allow for inflation of at least the cervical end portion of the vaginal barrel by air or other transparent fluid. This requires the speculum to seal off at least that part of the vaginal barrel to be inflated, a transparent fluid tight septum or plug within the bore of the speculum to prevent outflow of pressurizing fluid therethrough and the provision of fluid supply means for the admission of pressurised fluid either to the bore of the speculum ahead of that septum or plug or directly into the sealed off part of the vaginal barrel.

Thus a fully functional vaginal speculum is a complex instrument comprising not only the actual tubular probe which enters the vagina but also said external equipment which may include a hand piece for manipulation of the probe, an eye piece to enable an operator to aim and position the probe, a light source for illuminating the cervical area, a camera or at least means for attaching a camera, supply means for the supply of pressurised transparent fluid, commonly air, and sealing means for the retention of the air or other fluid under pressure within the vaginal barrel.

WO 03/065885 PCT/AU03/00117 2 It is of course essential for at least the tubular probe to be sterile before it is inserted into the vagina. Thus it is customary for the tubular probe to be readily separable from and attachable to the external equipment, either to permit it being sterilized between operations or, more preferably, disposed of at the end of an operation and replaced by a previously unused probe for the next operation.

International Application PCT/AU00/00267 Medical Limited) (International Publication No. WO 00/64329), describes a prior known vaginal speculum displaying embodiments of the various features mentioned above.

That prior art speculum includes a single use, disposable tubular probe furnished with a domed sealing element. In clinical trials of that prior art speculum it proved to be generally satisfactory as the domed sealing element seals against a circumferential zone of the internal tissue defining the vaginal orifice, and is suitable for use with women having different sized and shaped vaginal orifices. The sealing element provides a low-pressure seal over a limited range of depths of penetration of the probe into the vagina and over a range of angular alignments of the probe. This prior art speculum relies upon the natural resilience of the so-called PC muscle surrounding the vaginal orifice to permit the orifice to expand and contract so as to allow penetration of the sealing element into the orifice and the maintenance of a seal therewith, throughout a limited range of depths of penetration. The sealing element of this prior art speculum can only form a low-pressure seal, and if the vaginal barrel is over pressurized, the zone where the sealing element contacts the vagina expands to allow the pressurising fluid, typically air, to escape.

Generally, women patients have found this prior art speculum to be more comfortable than prior art duck-bill speculums and the like. However, one disadvantage relating to this prior art speculum, is that in the event where the vagina is over pressurised and air escapes the seal zone, the patient generally becomes embarrassed as the noise generated as the air escapes sounds similar to flatulence or to noises generated during some forms of sexual intercourse. This embarrassment may deter some women from undergoing regular pap smear tests and cervical examinations.

The present invention seeks to ameliorate the disadvantages associated with the prior art.

WO 03/065885 PCT/AU03/00117 3 Summary of Invention According to one aspect the invention consists in a vaginal speculum comprising an elongate tubular probe for penetrating the vagina, said probe is encircled by an annular sealing element spaced from the leading end of the probe which seals the vaginal orifice, a hand piece having a bore therethrough, said elongate tubular probe being detachably fitted within said bore of said hand piece, characterised in that said probe has a portion between said sealing element and said leading end that has a cross-section which is substantially ovoid in shape.

Preferably said leading end has a narrow tip.

Preferably said annular sealing element seals only against a circumferential zone of the internal tissue defining the vaginal orifice and is shaped as a surface of revolution wherein the diameter of the sealing surface increases progressively with axial distance from the leading end of the sealing element and wherein the rate of increase diminishes progressively with said axial distance.

Preferably said annular sealing element is dome shaped.

Preferably said annular sealing element is formed of a foamed synthetic plastics material.

Preferably said portion of said probe having an ovoid cross section contains first and second substantially parallel passageways, the first passageway passing through the whole length said probe, and the second passageway being of a smaller diameter than said first passageway.

Preferably said hand piece comprises a main body and a handgrip.

Preferably a camera housed in an elongate housing projects from said main body and is adapted to extend along said second passageway when said probe is fitted to said hand piece.

Preferably said second passageway is sealed by a lens at or near said leading of said probe.

WO 03/065885 PCT/AU03/00117 4 Brief Description of Drawings Figure 1 is a rear perspective view of a speculum according to a first embodiment of the present invention.

Figure 2 is a front perspective view of the speculum shown in Figure 1.

Figure 3 is a front perspective view of the probe of the speculum shown in Figure 1.

Figure 4 is a rear perspective view of the probe shown in Figure 3.

Figure 5 is a plan view of the probe of Figure 3.

Figure 6 is a front end view of the probe shown in Figure 3.

Figure 7 is a cross-sectional view through A-A of the probe shown in Figure Figure 8 is a front perspective view of the hand piece of the speculum shown in Figure 1.

Figure 9 is an elevational view of the hand piece shown in Figure 8.

Figure 10 is a front end view of the hand piece shown in Figure 8.

Figure 11 is a front perspective view of a speculum according to a second embodiment of the present invention.

Figure 12 is a front perspective view of the probe of the speculum shown in Figure 11.

Figure 13 is a rear perspective view of the probe shown in Figure 12.

Figure 14 is an elevation view of the speculum shown in Figure 11.

Figure 15 is an end view of the speculum shown in Figure 11.

Figure 16 is a front perspective view of the handpiece of the speculum shown in Figure 11.

Mode of Carrying out Invention Figures 1 and 2 depict a first embodiment of a speculum 1 intended for use in the examination of the vagina. Speculum 1 comprises an elongate tubular probe 2 adapted to be detachably fitted to hand piece 3 having a main body 4 and a handgrip An annular sealing element 6 encircles probe 2. Annular sealing element 6 is a dome shaped shell having a central hole through which probe 2 totally extends in the axial direction of the dome. Preferably annular sealing element 6 is in accordance with the sealing element WO 03/065885 PCT/AU03/00117 described in International Publication No. WO 00/64329 and can be manufactured in accordance with the method described in International Publication No. WO 01/89805.

Probe 2 which is shown in greater detail in Figures 3 to 7 without annular sealing element 6, has a tubular rear-portion 7 adapted to be detachably fitted within bore 8 of main body 4 of the hand piece 3. Probe 2 also has a fore-portion 9 which terminates in a narrow tip 10 that tapers from a high end zone 11 to a low end zone 12.

Two substantially parallel passageways 15 and 16 run substantially along the length of fore-portion 9. Primary passageway 15 extends into and through the rear-portion 7 and therefore passes through the whole length of probe 2. Secondary passageway 16 is of a substantially smaller diameter to that of primary passageway 15 and extends only through the fore-portion 9 of probe 2.

Figures 8 to 10 show hand piece 3 in greater detail. Handgrip 5 is pivotally mounted to main body 4 in an adjustable manner, so that a medical practitioner can adjust the handgrip relative to probe 2. The front face 19 of main body 4 has a plurality light emitting diodes 20 and 21 located thereon to illuminate the cervical area when probe 2 is inserted into a vagina.

A camera 22 housed in an elongate housing 23 projects from front face 19. When the rear-portion of probe 2 is fitted to bore 8 in main body 4, the camera 22 and its housing 23 extend into passageway 15 with the front end of the camera 22 near narrow tip 10. Preferably the be camera will be sealed within passageway 15 of probe 2 by a lens, which may for instance be as simple as a flat piece of Perspex or as sophisticated as a custom built lens. This lens is slightly recessed back from the narrow tip 10, to prevent or minimise the lens being smeared in use. As the camera is located near the leading end of probe 2 near the narrow tip 10, the camera may utilize a fish eye lens that broadens the area viewed.

The camera may be of any suitable type or resolution. It may for instance be a lowresolution camera having around a hundred thousand pixels, or may be a more sophisticated high-resolution camera of more than a million pixels. The camera may be a CCD or CMOS sensor type, and can be either digital or analogue. Preferably the camera will have a diameter of 8mm or less. The hand piece 3 will preferably house the necessary camera control unit that WO 03/065885 PCT/AU03/00117 6 powers the camera. Preferably the camera is operated by wireless, Blue-tooth or other electronic gear. Preferably the image captured by the camera will be viewable on a digital monitor that may form part of a computerised diagnostic system. With such a system the medical practitioner will view the interior of the vagina by viewing the monitor rather than using a prior art eyepiece fitted to the speculum.

In order to allow air to be introduced into the vagina an air supply hose (not shown) is connected to an air"inlet port 24 on handgrip 5 which delivers air through handgrip 5 to probe 2, through an air delivery passageway The rear-portion 7 of probe 2 extends rearwardly from main body 4 when probe 2 is fitted to hand piece 3. A disposable closure cap 26 seals rear-portion 7 of probe 2 to prevent air from escaping therefrom. Closure cap 26 preferably includes an access grommet 27 through which gynecological tools or pap smear spatulas loaded into probe may project. As the medical practitioner will rely solely on images captured by the camera 22 and displayed on a monitor, the access grommet 27 may be of considerably larger size, than in the prior art, as there is no requirement to place an eyepiece at the rear of probe 2. By providing a larger access grommet 27, larger gynecological tools or pap smear spatulas may project therethrough.

An important feature of the present invention is that the fore-portion 9 of probe 2 is ovoid or "egg-shaped" in cross section. This cross sectional ovoid shape has two important functions.

Firstly, it has been found that utilizing a cross sectional ovoid shape on fore portion 9 of probe 2 assists in minimising noise generated as air escapes the seal zone in an over pressurised vagina, when the speculum is used in a like manner to the speculum described in International Publication No. WO 00/64329. Secondly, the ovoid shape cross section allows for a secondary passageway 16 of smaller diameter to run parallel to the primary passageway 15. Whilst the primary passageway 15, conventionally allows medical practitioners to physically access the vagina with tools, the smaller diameter secondary passageway 16 allows for camera 22 to be located near the leading end of probe 2 near the narrow tip 10, which has distinct advantages in viewing the interior of the vagina.

Figures 11, 14, 15 and 16 depict a second embodiment of a speculum 101 intended for use in the examination of the vagina. Speculum 101 comprises an elongated tubular probe 102, WO 03/065885 PCT/AU03/00117 7 adapted to be detachably fitted to hand piece 103 having a main body 104 and a handgrip 105.

In this second embodiment handgrip 105 projects upwardly from main body 104, rather than projecting downwardly as does handgrip 5 with respect to main body 4, of the first embodiment.

Upwardly projecting handgrip 105, allows for speculum 101 to be manipulated and held within the patient by the medical practioner in an ergonomic fashion.

An annular sealing element 106 encircles probe 102. Annular sealing element 106 is a dome shaped shell having a central hole through which probe 102 totally extends in the axial direction of the dome. Preferably annular sealing element 106, is similar to that of sealing element 6 of the earlier described first embodiment.

Probe 102 which is shown in greater detail in Figures 12 and 13 without annular sealing element 106, has a tubular rear-portion 107 adapted to be detachably fitted within bore 108 of main body 104 of the hand piece 103. Probe 102 also has a fore-portion 109 which terminates in a narrow tip 110 that tapers from a high end zone 111 to a low end zone 112.

Probe 102, in a similar manner to probe 2 of the first embodiment, has passageways for delivery of air, the carrying of a camera or its components and is adapted for illuminating the cervical area of the vagina from light emitting diodes carried on hand piece 103. Furthermore, the image captured by the camera, like that of the first embodiment will be viewable on a digital monitor that may form part of a computerised diagnostic system.

Like that of the first embodiment, an important feature of the second embodiment of the present invention is that the fore-portion 109 of probe 102 is ovoid or "egg-shaped" in cross section. In the second embodiment this "ovoid" feature serves the same important functions as that earlier described in relation to the first embodiment.

Claims (11)

1. A vaginal speculum comprising an elongate tubular probe for penetrating the vagina, said probe is encircled by an annular sealing element spaced from the leading end of the probe which seals the vaginal orifice, a hand piece having a bore therethrough, said elongate tubular probe being detachably fitted within said bore of said hand piece, characterised in that said probe has a portion between said sealing element and said leading end that has a cross-section which is substantially ovoid in shape.

2. A vaginal speculum as claimed in claim 1, wherein said leading end of said probe has a narrow tip.

3. A vaginal speculum as claimed in claim 1, wherein said annular sealing element seals only against a circumferential zone of the internal tissue defining the vaginal orifice and is shaped as a surface of revolution wherein the diameter of the sealing surface increases progressively with axial distance from the leading end of the sealing element and wherein the rate of increase diminishes progressively with said axial distance.

4. A vaginal speculum as claimed in claim 1, wherein said annular sealing element is dome shaped.

A vaginal speculum as claimed in claim 1, wherein said annular sealing element is formed of a foamed synthetic plastics material.

6. A vaginal speculum as claimed in claim 1, wherein said portion of said probe having an ovoid cross section contains first and second substantially parallel passageways, the first passageway passing through the whole length said probe, and the second passageway being of a smaller diameter than said first passageway.

7. A vaginal speculum as claimed in claim 1, wherein said hand piece comprises a main body and a handgrip. WO 03/065885 PCT/AU03/00117 9

8. A vaginal speculum as claimed in claim 6, wherein a camera housed in an elongate housing projects from said main body and is adapted to extend along said second passageway when said probe is fitted to said hand piece.

9. A vaginal speculum as claimed in claim 8, wherein said second passageway is sealed by a lens at or near said leading of said probe.

A vaginal speculum as claimed in claim 9, wherein in use the handgrip projects upwardly from said main body.

11. A vaginal speculum as claimed in claim 9, wherein in use the handgrip projects downwardly from said main body.