WO2007131263A1

WO2007131263A1 - Examination device

Info

Publication number: WO2007131263A1
Application number: PCT/AU2007/000624
Authority: WO
Inventors: Clemens Van Der Weegen
Original assignee: Ssh Australia Pty Limited
Priority date: 2006-05-12
Filing date: 2007-05-11
Publication date: 2007-11-22

Abstract

An examination device for examining a body cavity such as a vagina, adapted to be mounted to a hand piece. The device comprises a tubular probe and a sealing element near the fore end of the probe is adapted to act as a seal for the vagina by sealing against a circumferential zone of the internal tissue defining the vaginal orifice. The probe is attached to the hand piece via an intermediate mounting member having a first end that is removably secured to the aft end of the probe and a opposed second end is adapted to be removably secured to the hand piece. The intermediate mounting member having a lateral entry port that allows for an elongate implement removably mounted in the device and passing through the probe for introduction into the vagina, such that the implement may be manipulated by a user. The intermediate mounting member having a second entry port for introducing fluid into the vagina.

Description

EXAMINATION DEVICE

TECHNICAL FIELD

This invention relates to examination devices of the kind used by physicians to examine the interiors of body cavities and/or orifices thereof and to facilitate sampling and/or surgical operations within the body cavities. In particular the present invention is primarily described with reference to an examination device for use in relation to the vagina.

BACKGROUND

There are a number of ways physicians routinely examine the interior of the vagina. One such method is to employ a known dilating speculum comprising a tubular array of two or more rigid, elongate leaves, which are inserted into the vagina of a patient and expanded in a radially outward direction to open the vagina for inspection.

Colposcopes are also routinely employed by physicians to examine the interior of the vagina through such a speculum. Colposcopes typically comprise a binocular microscope and an illuminating unit which allows the physician to conduct the examination of the vagina, even though it is set up at about 300mm away from the vagina.

Some of the disadvantages of dilating speculums and colposcopes are recited in the "Background Art" of US Patent No. 6,226,826 (Van Der Weegen).

US Patent No. 6,226,826 discloses an examination device for examining the interior of a body cavity, which is simple to use for close up examination and through which biopsy samples may be obtained and surgery conducted. Fig. 1 depicts an embodiment which is particularly suited to the examination of a vagina. The examination employs a tubular probe mounted onto a hand piece, the tubular probe having a shield at its fore end that is adapted to engage the tissue externally of the vaginal opening. The rear end of the tubular probe extends from the rear of the hand piece and is adapted to have a closure, with an eyepiece, fitted thereto. The eyepiece is able to have a camera fitted thereto. The handpiece contains a light source that is able to illuminate the tubular probe when it is inserted into the vagina to assist the examination thereof. The closure also has a sealable entry port for the insertion of a surgical implement or sampling device through the rear of the tubular probe. A problem associated with the location of the entry port, is that a physician finds it difficult to hold the hand piece in one hand with the shield pressed firmly against the external tissue of the vagina, whilst endeavouring to manipulate the surgical implement or sampler from the rear of the device whilst also trying to view inside the vagina. Another problem with this device is that the shield does not always provide an effective seal as it seals on the external tissue, and such device requires air to inflate the sealed vagina in order for the cervix to be examined.

US 6,719,687 (Van Der Weegen) discloses a vaginal speculum (or examination device) which overcomes the sealing problems of US 6,626,826 by employing an annular sealing element in the form of a thick walled, domed shell of polyethylene foam fitted to the tubular probe that is inserted into the vagina. However, as can be seen in Fig. 2 of that document, the only way to introduce a surgical implement or other implement is through the closure/eyepiece fitted to the rear of the tubular probe. As such this device suffers from the same manipulation problems that occur with the abovementioned device of US 6,719,687.

In recent years, physicians have employed the earlier mentioned colposcopes in combination with ultraviolet light for use in diagnosing disease of the cervix and inspecting vaginas subsequent to sexual assault. Also, spectropes have been used in a similar fashion in combination with ultraviolet light for the same purpose. This type of analysis is typically referred to as fluorescence spectroscopy and colposcopy and is described in US Patent No. 6,766,184 (Utzinger et al). A problem associated with fluorescent colposcopy and spectroscopy is that the devices employed are usually located a distance of about 300mm from the cervix at a location outside the vaginal opening and ultraviolet light must be directed towards the vaginal cavity. In order to carry out such examination the physicians must turn off or lower the lighting in the examination room, which in some instances is undesirable or inconvenient.

A further known device capable of being used to diagnose disease of the cervix is described in US Patent No. 6,818,903 (Schomacker et al). In that patent as shown in Fig. 4C, a known dilating speculum is used to open the vagina for inspection. Using a probe that is outside of the vagina and not intended to contact tissue, the cervical area is illuminated by light, for the purposes of spectral analysis, that includes the use of fluorescence spectroscopy. However, a problem associated with such device is that the use of the known dilating speculum may block all or part of the illumination path, thereby causing shadows, if the probe is misaligned. In order to improve the chances of obtaining at least one set of spectral data that is not affected by glare, shadow and/or obstruction multiple sets of spectral data must be captured. The problem of misalignment occurs because the probe carrying the light source is not connected to the dilating speculum.

The object of the present invention is to provide an examination device that overcomes at least one of the problems associated with the prior art.

SUMMARY OF INVENTION

According to a first aspect the present invention consists in an examination device for examining a vagina, said device adapted to be mounted to a hand piece, said device comprising a tubular probe having a first, forward end and a second, rearward end, a sealing element near the fore end of said tubular probe adapted to act as a seal for the vagina to reduce egress of fluid therefrom by sealing against a circumferential zone of the internal tissue defining the vaginal orifice characterised in that said tubular probe is attached to said hand piece via an intermediate mounting member having a first end that is removably secured to the aft end of said tubular probe and a opposed second end is adapted to be removably secured to said hand piece, said intermediate mounting member having a lateral entry port that allows for an elongate implement removably mounted in said device and passing through said tubular probe for introduction into said vagina, such that said implement may be manipulated by a user, and said intermediate mounting member having at least a second entry port for introducing fluid into the vagina.

Preferably, said first lateral entry port allows for said elongate implement passing therethrough at an acute angle to the longitudinal axis of said intermediate mounting member.

Preferably, a tubular guide member projects externally from said port in a substantially rearward direction in order to guide the rearward end of said implement away from said intermediate mounting member, said tubular guide member having a longitudinal axis that is at an acute angle relative to the longitudinal axis of said intermediate mounting member.

Preferably, said intermediate mounting member is adapted to be rotatably moved relative to said hand piece, thereby allowing said tubular guide member to be radially oriented. Preferably, a grommet and seal arrangement is adapted to be secured to the free end of said tubular guide member, and is adapted to allow said implement to pass through.

Preferably, said hand piece comprises an illumination assembly for illuminating the interior of said vagina.

Preferably, said hand piece comprises a first digital imaging acquisition means for viewing and/or capturing an image of the interior of said vagina.

Preferably, said illumination assembly is adapted to emit ultraviolet light.

Preferably, said first digital imaging acquisition means is adapted to be connected to a computer.

Preferably, said elongate implement has a flexible stem.

Preferably, said elongate implement is a surgical implement or a sampling implement.

Preferably, a guide means is located at or near the fore end of said tubular probe for guiding said implement therethrough.

Preferably, said guide means is removable from said tubular probe.

Preferably, said sealing element is a dome-shaped shell. Preferably, said sealing element is made of a closed cell plastics foam.

Preferably, said plastics foam is polyethylene.

Preferably, said hand piece may be removed from the second end of said intermediate mounting member, thereby allowing straight through viewing or image capture via a second digital imaging acquisition means not mounted in said hand piece.

Preferably, said fluid introduced through said second port is air.

According to a second aspect, the present invention consists in an examination device for examining a vagina, said device including a tubular probe having a first, forward end and a second, rearward end, the tubular probe being adapted to be engaged with a hand piece by which the probe is manipulated, and a sealing element near the fore end of said tubular probe adapted to act as a seal for the vagina to reduce egress of fluid therefrom by sealing against a circumferential zone of the internal tissue defining the vaginal orifice, said hand piece including an illumination assembly for illuminating the interior of said vagina and a first digital imaging acquisition means for viewing and/or capturing an image of the interior of said vagina characterised in that said tubular probe is attached to said hand piece via an intermediate mounting member having a first end that is removably secured to the aft end of said tubular probe and a opposed second end removably secured to said hand piece, said intermediate mounting member having a first lateral entry port that allows for an elongate implement removably mounted in said device and passing through said tubular probe for introduction into said vagina, such that said implement may be manipulated by a user, and said intermediate mounting member having at least a second entry port for introducing fluid into the vagina.

Preferably, said intermediate mounting member is adapted to be rotatably moved relative to said handpiece, thereby allowing tubular guide member to be radially oriented.

Preferably, a grommet and seal arrangement is adapted to be secured to the free end of said tubular guide member, and is adapted to allow said implement to pass through.

Preferably, said tubular probe and said intermediate mounting member are provided with means for transmitting light emitted from said illumination assembly.

Preferably, said illumination assembly is adapted to emit ultraviolet light.

Preferably, said digital imaging acquisition means is adapted to be connected to a computer.

Preferably, said elongate implement has a flexible stem. Preferably, said elongate implement is a surgical implement or a sampling implement.

Preferably, said guide means is a V-shaped member projecting from the inner surface of said tubular probe.

Preferably, said sealing element is made of a closed cell plastics foam.

Preferably, said sealing element is a dome-shaped shell.

Preferably, said plastics foam is polyethylene.

Preferably, said fluid introduced through said second port is air.

An examination device for examining the interior a body cavity, said device adapted to be mounted to a hand piece, said device comprising a tubular probe having a first, forward end and a second, rearward end, a sealing element near the fore end of said tubular probe adapted to act as a seal for said body cavity to reduce egress of fluid therefrom by sealing against a circumferential zone of the tissue defining the orifice of said body cavity characterised in that said tubular probe is attached to said hand piece via an intermediate mounting member having a first end that is removably secured to the aft end of said tubular probe and a opposed second end is adapted to be removably secured to said hand piece, said intermediate mounting member having a lateral entry port that allows for an elongate implement removably mounted in said device and passing through said tubular probe for introduction into said body cavity, such that said implement may be manipulated by a user,

Preferably said intermediate mounting member having at least a second entry port for introducing fluid into said body cavity.

Preferably said first lateral entry port allows for said elongate implement passing therethrough at an acute angle to the longitudinal axis of said intermediate mounting member. Preferably a tubular guide member projects externally from said port in a substantially rearward direction in order to guide the rearward end of said implement away from said intermediate mounting member, said tubular guide member having a longitudinal axis that is at an acute angle relative to the longitudinal axis of said intermediate mounting member.

Preferably said intermediate mounting member is adapted to be rotatably moved relative to said hand piece, thereby allowing said tubular guide member to be radially oriented.

Preferably a grommet and seal arrangement is adapted to be secured to the free end of said tubular guide member, and is adapted to allow said implement to pass through.

Preferably said hand piece comprises an illumination assembly for illuminating the interior of said body cavity.

Preferably said hand piece comprises a first digital imaging acquisition means for viewing and/or capturing an image of the interior of said body cavity.

Preferably said illumination assembly is adapted to emit ultraviolet light.

Preferably said first digital imaging acquisition means is adapted to be connected to a computer.

Preferably said elongate implement has a flexible stem.

Preferably said elongate implement is a surgical implement or a sampling implement.

Preferably a guide means is located at or near the fore end of said tubular probe for guiding said implement therethrough.

Preferably said guide means is a V-shaped member projecting from the inner surface of said tubular probe.

Preferably said sealing element is a dome-shaped shell.

Preferably said sealing element is made of a closed cell plastics foam.

Preferably said plastics foam is polyethylene. Preferably said fluid introduced through said second port is air.

In one embodiment said body cavity is a vagina. In another embodiment said body cavity is a rectum.

BRIEF DESCRIPTION OF DRAWINGS

Fig. 1 is an perspective view of a first embodiment of an examination device of the present invention, with a sampling implement fitted thereto.

Fig .2 is a reduced exploded perspective view of the examination device shown in fig 1.

Fig. 3a is an elevation view of the intermediate mounting member component of the examination device shown in Fig. 1.

Fig. 3b is a plan view of the intermediate mounting member shown in Fig 3 a.

Fig. 3c is a rear view of the intermediate mounting member shown in Fig 3a.

Fig. 3d is a fore-end view of the intermediate mounting member shown in Fig 3a.

Fig. 3e is an aft-end view of the intermediate mounting member shown in Fig 3a.

Fig. 3f is an enlarged view of the detail A in Fig 3b.

Fig. 4a is an enlarged cross-sectional view of the intermediate mounting member through IV - IV in Fig. 3b.

Fig 4b is an enlarged view of Fig 3d.

Fig. 5 is a perspective schematic view of tubular probe of the examination device shown in Fig. 1, depicting the internal guide member. Fig. 6 is a plan view of the tubular probe shown in Fig 5.

Fig .7 is an elevation view of the tubular probe shown in Fig 5.

Fig. 8 is an end view of the tubular probe shown in Fig 5.

Fig. 9 is a plan view of a rectal examination tubular probe.

Fig. 10 is an elevation view of a second embodiment of an examination device of the present invention without showing a tubular probe connected thereto.

DESCRIPTION OF PREFERRED EMBODIMENT

Figs. 1 and 2 depict a first embodiment of an examination device intended for use in the examination of the vagina. The device comprises an elongate tubular probe 1 and intermediate mounting member 3, both adapted to be used in conjunction with a hand piece 2.

Tubular probe 1 is a colourless transparent plastic moulding which may, for example, be of acrylic having a bore Ia therethrough. For ease of reference, tubular probe 1 can be described as having a first end 4 and a second end 5. A sealing element 6 of a larger diameter than the body of the tubular probe 1 is located thereon.

The sealing element 6 is similar to "sealing element 13" depicted in Fig. 1 of US Patent No. 6719687 and functions in a similar fashion. It is preferably a thick walled hemisphere (dome- shaped shell) of closed cell, dense polyethylene foam with a hole at its centre through which the probe 1 tightly extends.

The hand piece 2 has a detachable mounting spigot 7 for mounting the intermediate mounting member 3. The hand piece 2 also has an illumination assembly (not shown) and a digital imaging acquisition means for viewing and/or capturing an image (not shown), therein. In this embodiment the hand piece 2 is also adapted to be connected to a computer/transformer (not shown) from which a low voltage power source of say 3-12 volts to power the illumination assembly and the digital imaging acquisition means is provided. The computer is preferably connected to a monitor (not shown).

The intermediate mounting member 3 is shown in greater detail in Figs 3(a)-3(f) and Figs 4(a) and 4(b), whilst the tubular probe 1 is shown in greater detail in Figs 5-8.

The intermediate mounting member 3, has a bore 8. The rear end 9 of intermediate mounting member 3 is adapted to slidably engage to mounting spigot 7, whilst the front end 10 of intermediate mounting member 3 is adapted to removably engage and support tubular probe 1. When tubular probe 1 is connected to the intermediate mounting member 3, the "central longitudinal axis" of each of these components align with one another. In Fig 4a, the central longitudinal axis Li of intermediate mounting member 3 is shown.

Intermediate mounting member 3 comprises two ports, the first being a lateral entry port 11 for an implement to pass through into bore 8, and the second being a fluid entry port 12 for introducing a fluid into the device for inflating the vaginal barrel of a patient, in a like manner to the device of US 6,226,826 and US 6,719,687. For ease of reference, the fluid supply tube is not shown. A thread 14a is disposed on member 14 for receiving a grommet and seal arrangement 14b for engagement therewith. The stem of implement of 15 passes through the grommet and seal arrangement.

A tubular guide member 14 projects externally from port 11 in a substantially rearward direction. The tubular guide member 14 has a longitudinal axis L2 that is at an acute angle, preferably less than 45°, to the longitudinal axis Lj of the intermediate mounting member 3. This arrangement allows for an elongate implement, such as a sampling implement 15 with a flexible plastic stem to be inserted through end 4 of probe 1 into the intermediate mounting member 3 and bent such that the rear end 18 of implement 15 passes through-port 11 and tubular guide member 14 therefore guiding the rear end of implement 15 away from said intermediate mounting member 3 as shown in Fig. 1. A thread 14a is disposed on member 14 for receiving a "grommet and seal" arrangement 14b for engagement therewith. The stem of implement of 15 passes through the grommet and seal arrangement 14b.

In order to keep the stem of implement 15 centralised in bore Ia of probe 1, a guide means may be located at or near the end 4 of probe 1. The guide means may for instance be a V-shaped guide member 16 projecting from the inner surface of probe 1. The stem of the implement may pass through the aperture 17 disposed between guide member 1 and the inner wall of probe 1. It should be appreciated that where said guide member 16 supports the stem of said implement is a location offset from the central axis of probe 1. This offset support of implement 15, and the "spring like" flexure of its 'stem, assists in the free end of the implement inserted in the vagina to tend towards a location proximal to the central longitudinal axis of probe 1, thereby assisting the physician in positioning and manipulating the implement.

An elongate projection 19 on the upper portion of intermediate mounting member 3 engages with a notch 20 on probe 1 during assembly, to ensure that V-shaped guide member 16 of probe 1 is correctly oriented relative to port 11 of intermediate mounting member 3.

It should be understood that whilst this embodiment is described with reference to a sampling implement 15, it should be understood that the implement 15 may in a different embodiment, be a surgical implement.

The examination device is usually supplied to a user as separate unassembled components of the tubular probe 1, hand piece 2 and intermediate mounting member 3. The device may be assembled for use by attaching the tubular probe 1 to intermediate mounting member 3, then subsequently mounting member 3 to the hand piece 2 via mounting spigot 7.

In this embodiment of the device, once the components have been assembled the sealing element 6 of the tubular probe 1 is at the front end of the examination device. A physician wishing to examine a vagina may bring the first end 4 of tubular probe 1 towards the opening of the vagina and insert it in a like manner to that shown in Fig. 5 of US Patent No. 6719687, thereby effecting a seal between the sealing element 6 and the annular zone of the normally internal surface of the vaginal orifice. Then in a similar fashion to that described in US Patent No. 6719687, the vaginal barrel may be inflated by air introduced into the device via fluid port entry port 12 on intermediate mounting member 3.

The illumination assembly within hand piece 2 projects light into the vaginal barrel. As hand piece 2 is connected to a computer and monitor, and a digital imaging acquisition means for viewing and/or capturing an image is incorporated within hand piece 2, the physician may examine the patient by viewing the image of the vaginal interior and cervix shown on the monitor, and may capture images thereof for storage on the computer or other storage media.

Where the device is used to introduce an implement into the vagina, such as sampling implement 15 depicted in Fig. 1, an advantage is that the physician may easily hold the hand piece 2 in one hand whilst manipulating rear end 16 of implement 15 in the other hand. The arrangement of the implement 15 extending through port 11 and tubular guide member 17, enables implement 15 to be far more easily manipulated than in the earlier mentioned prior art. The arrangement allows for sampling devices or surgical instruments to be passed through the device and into the vagina for taking samples or conducting minor surgery. An advantage of such an arrangement is that the physician can manipulate such sampling or surgical devices laterally of the device and his/her hands do not block the field of vision, as is sometimes the case when using known colposcopes.

The tubular probe 1 is preferably a disposable item which may be supplied in a sterile package for use by a physician at the time of inspection. However, it may in another embodiment be re-usable and adapted for auto-clave sterilisation, along with the sealing element 6.

The sealing element 6 has the purpose of providing a seal between the area being examined and that of the hand piece 2 and the intermediate mounting member 3, in order to prevent contamination of the latter components. It should be understood that the intermediate mounting member 3 may either be a disposable member or re-usable. In the case of intermediate mounting member 3 being reusable, it may preferably be adapted for auto-clave sterilisation.

It should be understood that the hand piece 2 of the present embodiment may for instance be purpose built for use with tubular probe 1 and intermediate mounting member 3. Such a hand piece 2, may incorporate a conventional light source for examining the interior of a vagina and the cervix. The illumination assembly may utilise light emitting diodes or other light bulbs, including annular or semi-annular shaped bulbs.

It should also be understood that the illuminating assembly within the hand piece may preferably have an ultraviolet light capacity, which allows for a fluorescence examination of the vagina and the cervix. A suitable fluorescence fluid of a known type could be introduced into the vagina to be used for the fluorescence examination. An advantage of this would be that sealing element 6 of the device effects both fluid and light a seal with the annular zone of the normally internal surface of the vaginal orifice. As such, the physician may not have to turn off or lower the lighting in the examination room to conduct a fluorescence examination, as is necessary with conventional fluorescence colposcopy and spectroscopy.

The illuminating assembly within the hand piece may preferably be one or more light emitting diodes (LED's) that have ultraviolet wave lengths, preferably about 370 nm. However, it should be understood that other ultraviolet wave lengths may be suitable. The use of the illuminating assembly with ultraviolet capacity disposed within the hand piece ensures that no misalignment of the light path occurs as is the case in the earlier mentioned US 6,818,903. This is because in the present embodiment the hand piece is connected to the tubular probe introduced into the vagina, and in use the hand piece does not move relative to the tubular probe.

Whilst the first embodiment is described with reference to an examination device for use in the examination of the vagina, it should be understood that the invention may also be used to examine other body cavities. For example, if tubular probe 1, was replaced by tubular probe 21 shown in Fig. 9, the examination device may be used for a rectal examination. In order for probe 21 to be introduced into the rectum a suitable "introducer" is required.

It should be also understood in other embodiments existing medical hand pieces with imaging equipment and associated computer systems may be used. One such known system marketed by the Korean company, Sometech Inc, is the Dr Camscope TM multifunctional cameras (model nos. DCS-I04T and DCSL -106) that are housed within a handpiece. If such a handpiece is used, the physician would be supplied with a detachable mounting spigot 7 to suit such handpiece for mounting the intermediate mounting member 3 thereon.

Fig. 10 depicts a second embodiment of an examination device. This examination device has a more portable type handpiece 2a, which may be used in conjunction with an internally disposed micro-camera as the digital imaging acquisition means for viewing and/or capturing an image, and a personal digital assistant type micro computer, with a compact MPEG4 recorder for recording and viewing. The handpiece 2a also inincludes an illumination assembly, which preferably are LEDs as described in the abovementioned embodiment. The handpiece 2a (and camera) may be connected to an intermediate mounting member 3 (similar to that of the first embodiment) via a tapered mounting spigot 7a. Whilst not shown in Fig. 10, it should be understood that a tubular probe 1 having a sealing element 6 (of the first embodiment) would be attached to intermediate mounting member 3. This would allow the insertion and manipulation of an implement 15. The micro-camera within hand piece 2a may be powered and connected to a computer by a computer lead 22, or alternatively it may be battery powered and use a wireless link with a computer or similar device.

Also in another not shown embodiment, the size and shape of tubular guide member 14 and entry port 11 of the intermediate mounting member 3 of the first and second embodiments, may differ to allow different sized implements to be used with the device.

Also in another not shown embodiment, an illumination assembly may be fitted, either permanently or removably, in the intermediate mounting member 3.

Also in another not shown embodiment, it should be understood that different coloured filters may be used in conjunction with the illuminating assembly to assist the detection of small blood vessels, abnormalities and the like.

The term "comprising" as used herein (and its grammatical variations) is used in the inclusive sense of "having" or "including" and not in the exclusive sense of "consisting only of.

Claims

CLAIMS:

1. An examination device for examining a vagina, said device adapted to be mounted to a hand piece, said device comprising a tubular probe having a first, forward end and a second, rearward end, a sealing element near the fore end of said tubular probe adapted to act as a seal for the vagina to reduce egress of fluid therefrom by sealing against a circumferential zone of the internal tissue defining the vaginal orifice characterised in that said tubular probe is attached to said hand piece via an intermediate mounting member having a first end that is removably secured to the aft end of said tubular probe and a opposed second end is adapted to be removably secured to said hand piece, said intermediate mounting member having a lateral entry port that allows for an elongate implement removably mounted in said device and passing through said tubular probe for introduction into said vagina, such that said implement may be manipulated by a user, and said intermediate mounting member having at least a second entry port for introducing fluid into the vagina.

2. An examination device as claimed in claim 1, wherein said first lateral entry port allows for said elongate implement passing therethrough at an acute angle to the longitudinal axis of said intermediate mounting member.

3. An examination device as claimed in claim 1, wherein a tubular guide member projects externally from said port in a substantially rearward direction in order to guide the rearward end of said implement away from said intermediate mounting member, said tubular guide member having a longitudinal axis that is at an acute angle relative to the longitudinal axis of said intermediate mounting member.

4. An examination device as claimed in claim 3, wherein said intermediate mounting member is adapted to be rotatably moved relative to said hand piece, thereby allowing said tubular guide member to be radially oriented.

5. An examination device as claimed in claim 4, wherein a grommet and seal arrangement is adapted to be secured to the free end of said tubular guide member, and is adapted to allow said implement to pass through.

6. An examination device as claimed in claim 1, wherein said hand piece comprises an illumination assembly for illuminating the interior of said vagina.

7. An examination device as claimed in claim 1, wherein said hand piece comprises a first digital imaging acquisition means for viewing and/or capturing an image of the interior of said vagina.

8. An examination device as claimed in claim 6, wherein said illumination assembly is adapted to emit ultraviolet light.

9. An examination device as claimed in claim 7, wherein said first digital imaging acquisition means is adapted to be connected to a computer.

10. An examination device as claimed in claim 1, wherein said elongate implement has a flexible stem.

11. An examination device as claimed in claim 1, wherein said elongate implement is a surgical implement or a sampling implement.

12. An examination device as claimed in claim 1, wherein a guide means is located at or near the fore end of said tubular probe for guiding said implement therethrough.

13. An examination device as claimed in claim 12, wherein said guide means is a V-shaped member projecting from the inner surface of said tubular probe.

14. An examination device as claimed in claim 1, wherein said sealing element is a dome- shaped shell.

15. An examination device as claimed in claim 1, wherein sealing element is made of a closed cell plastics foam.

16. An examination device as claimed in claim 1 , wherein said plastics foam is polyethylene.

17. An examination device as claimed in claim 1, wherein said fluid introduced through said second port is air.

18. An examination device for examining a vagina, said device including a tubular probe having a first, forward end and a second, rearward end, the tubular probe being adapted to be engaged with a hand piece by which the probe is manipulated, and a sealing element near the fore end of said tubular probe adapted to act as a seal for the vagina to reduce egress of fluid therefrom by sealing against a circumferential zone of the internal tissue defining the vaginal orifice, said hand piece including an illumination assembly for illuminating the interior of said vagina and a first digital imaging acquisition means for viewing and/or capturing an image of the interior of said vagina characterised in that said tubular probe is attached to said hand piece via an intermediate mounting member having a first end that is removably secured to the aft end of said tubular probe and a opposed second end removably secured to said hand piece, said intermediate mounting member having a first lateral entry port that allows for an elongate implement removably mounted in said device and passing through said tubular probe for introduction into said vagina, such that said implement may be manipulated by a user, and said intermediate mounting member having at least a second entry port for introducing fluid into the vagina.

19. An examination device as claimed in claim 18, wherein said first lateral entry port allows for said elongate implement passing therethrough at an acute angle to the longitudinal axis of said intermediate mounting member.

20. An examination device as claimed in claim 18, wherein a tubular guide member projects externally from said port in a substantially rearward direction in order to guide the rearward end of said implement away from said intermediate mounting member, said tubular guide member having a longitudinal axis that is at an acute angle relative to the longitudinal axis of said intermediate mounting member.

21. An examination device as claimed in claim 20, wherein said intermediate mounting member is adapted to be rotatably moved relative to said handpiece, thereby allowing tubular guide member to be radially oriented.

22. An examination device as claimed in claim 21, wherein a grommet and seal arrangement is adapted to be secured to the free end of said tubular guide member, and is adapted to allow said implement to pass through.

23. An examination device as claimed in claim 18, wherein, said tubular probe and said intermediate mounting member are provided with means for transmitting light emitted from said illumination assembly.

24. An examination device as claimed in claim 18, wherein said illumination assembly is adapted to emit ultraviolet light.

25. An examination device as claimed in claim 18, wherein said digital imaging acquisition means is adapted to be connected to a computer.

26. An examination device as claimed in claim 18, wherein said elongate implement has a flexible stem.

27. An examination device as claimed in claim 18, wherein said elongate implement is a surgical implement or a sampling implement.

28. An examination device as claimed in claim 18, wherein a guide means is located at or near the fore end of said tubular probe for guiding said implement therethrough.

29. An examination device as claimed in claim 28, wherein said guide means is a V-shaped member projecting from the inner surface of said tubular probe.

30. An examination device as claimed in claim 18, wherein, said sealing element is a dome- shaped shell.

31. An examination device as claimed in claim 18, wherein said sealing element is made of a closed cell plastics foam.

32. An examination device as claimed in claim 31 , wherein said plastics foam is polyethylene.

33. An examination device as claimed in claim 18, wherein said hand piece may be removed from the second end of said intermediate mounting member, thereby allowing straight through viewing or image capture via a second digital imaging acquisition means not mounted in said hand piece.

34. An examination device as claimed in claim 18, wherein said fluid introduced through said second port is air.

35. An examination device for examining the interior a body cavity, said device adapted to be mounted to a hand piece, said device comprising a tubular probe having a first, forward end and a second, rearward end, a sealing element near the fore end of said tubular probe adapted to act as a seal for said body cavity to reduce egress of fluid therefrom by sealing against a circumferential zone of the tissue defining the orifice of said body cavity characterised in that said tubular probe is attached to said hand piece via an intermediate mounting member having a first end that is removably secured to the aft end of said tubular probe and a opposed second end is adapted to be removably secured to said hand piece, said intermediate mounting member having a lateral entry port that allows for an elongate implement removably mounted in said device and passing through said tubular probe for introduction into said body cavity, such that said implement may be manipulated by a user,

36. An examination device as claimed in claim 35 wherein said intermediate mounting member having at least a second entry port for introducing fluid into said body cavity.

37. An examination device as claimed in claim 35, wherein said first lateral entry port allows for said elongate implement passing therethrough at an acute angle to the longitudinal axis of said intermediate mounting member.

38. An examination device as claimed in claim 35, wherein a tubular guide member projects externally from said port in a substantially rearward direction in order to guide the rearward end of said implement away from said intermediate mounting member, said tubular guide member having a longitudinal axis that is at an acute angle relative to the longitudinal axis of said intermediate mounting member.

39. An examination device as claimed in claim 37, wherein said intermediate mounting member is adapted to be rotatably moved relative to said hand piece, thereby allowing said tubular guide member to be radially oriented.

40. An examination device as claimed in claim 38, wherein a grommet and seal arrangement is adapted to be secured to the free end of said tubular guide member, and is adapted to allow said implement to pass through.

41. An examination device as claimed in claim 38, wherein said hand piece comprises an illumination assembly for illuminating the interior of said body cavity.

42. An examination device as claimed in claim 35, wherein said hand piece comprises a first digital imaging acquisition means for viewing and/or capturing an image of the interior of said body cavity.

43. An examination device as claimed in claim 41, wherein said illumination assembly is adapted to emit ultraviolet light.

44. An examination device as claimed in claim 42, wherein said first digital imaging acquisition means is adapted to be connected to a computer.

45. An examination device as claimed in claim 35, wherein said elongate implement has a flexible stem.

46. An examination device as claimed in claim 35, wherein said elongate implement is a surgical implement or a sampling implement.

47. An examination device as claimed in claim 35, wherein a guide means is located at or near the fore end of said tubular probe for guiding said implement therethrough.

48 An examination device as claimed in claim 47, wherein said guide means is a V-shaped member projecting from the inner surface of said tubular probe.

49. An examination device as claimed in claim 35, wherein said sealing element is a dome- shaped shell.

50. An examination device as claimed in claim 35, wherein sealing element is made of a closed cell plastics foam.

51. An examination device as claimed in claim 35, wherein said plastics foam is polyethylene.

52. An examination device as claimed in claim 35, wherein said fluid introduced through said second port is air.

53. An examination device as claimed in claim 35, wherein said body cavity is a vagina.

54. An examination device as claimed in claim 35, wherein said body cavity is a rectum.