WO2009059355A1

WO2009059355A1 - Examination device

Info

Publication number: WO2009059355A1
Application number: PCT/AU2008/001633
Authority: WO
Inventors: Clemens Van Der Weegen
Original assignee: Ssh Australia Pty Ltd
Priority date: 2007-11-05
Filing date: 2008-11-04
Publication date: 2009-05-14

Abstract

An examination device for examining a vagina, the device adapted to be mounted to a handpiece and for allowing a fluid to be introduced into the vagina, said device comprising a tubular probe having a first, forward end and a second, rearward end, a sealing element near the fore end of the tubular probe adapted to act as a seal for the vagina to reduce egress of fluid therefrom by sealing against a zone of the tissue defining the vaginal orifice. The tubular probe having a first lateral entry port that allows for an elongate implement removably mounted in the device and passing through the tubular probe for introduction into the vagina, such that the implement may be manipulated by a user.

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 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, spectrocopes 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, which 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 handpiece and for allowing a fluid to be introduced into said vagina, 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 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.

Preferably said first lateral entry port allows for said elongate implement passing therethrough at an acute angle to the longitudinal axis of said tubular probe.

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 probe, said tubular guide member having a longitudinal axis that is at an acute angle relative to the longitudinal axis of said probe.

Preferably said probe is adapted to be rotatably moved relative to said handpiece, 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 tubular probe having a second lateral port for introducing fluid into the vagina. Preferably said handpiece having a port for introducing fluid into said tubular probe.

Preferably said handpiece 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 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 into said vagina is air.

According to a second aspect the present invention consists in an examination device for examining a body cavity, said device adapted to be mounted to a handpiece and for allowing a fluid to be introduced into said body cavity, 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 body cavity to reduce egress of fluid therefrom by sealing against a circumferential zone of the internal tissue defining the orifice of said body cavity, characterised in that said tubular probe 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 body cavity, such that said implement may be manipulated by a user.

According to a third aspect the present invention consists in an examination device for examining a vagina, said device adapted to be mounted to a handpiece and for allowing a fluid to be introduced into said vagina, 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 zone of the tissue defining the vaginal orifice, characterised in that said tubular probe 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.

Preferably the light source from said illumination assembly is light from the spectrum which allows for flouresence examinations of the vagina and cervix. Preferably said illumination assembly has an ultraviolet capacity and/or an infrared capacity.

According to a fourth aspect the present invention consists in an examination device for examining the interior of a body cavity, said device adapted to be mounted to a handpiece, 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 zone of the tissue defining the orifice of said body cavity, characterised in that said tubular probe 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 body cavity, such that said implement may be manipulated by a user.

BRIEF DESCRIPTION OF DRAWINGS

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

Fig .2 is an exploded perspective view of the examination device shown in Fig 1.

Fig. 3a is an enlarged elevation view of the tubular probe component of the examination device shown in Fig. 1.

Fig. 3b is a plan view of the tubular probe shown in Fig 3a. Fig. 3c is a bottom view of the tubular probe shown in Fig 3a. Fig. 4 is an aft end view of the tubular probe shown in Fig 3a. Fig. 5 is a cross-sectional schematic view of the probe through lines V-V of Fig 4.

Fig. 6 is a transparent view of the fore end of the tubular probe of the examination device shown in Fig. 1, depicting the internal guide member.

DESCRIPTION OF PREFERRED EMBODIMENT

Figs. 1 to 6 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 adapted to be used in conjunction with a handpiece 2.

Tubular probe 1 is preferably a colourless transparent plastic moulding which may, for example, be of acrylic, having a bore Ia. For ease of reference, tubular probe 1 can be described as having a first (fore) end 4 and a second (rearward) end 5. A sealing element 6 of a larger diameter than the body of the tubular probe 1 is disposed 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. A circular rib 20 disposed on probe 1, limits the rearward travel of sealing element 6 relative to probe 1.

The handpiece 2 has a detachable mounting spigot 7 for mounting the tubular probe 1. The handpiece 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 handpiece 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).

Tubular probe 1 comprises two ports, the first being a lateral entry port 11 for an implement to pass through into bore Ia (best shown in Fig 4), 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 Ll of the tubular probe 1. 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 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 tubular probe 1 as shown in Fig. 1. 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, as shown in Fig 5. 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 ensures that the guide member 17 and where stem is supported by the guide member does not obstruct the central axis.

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, handpiece 2 and spigot 7. The device may be assembled for use by attaching the tubular probe 1 to handpiece 2 via mounting spigot 7. Alternatively, tubular probe 1 may be directly mounted to handpiece 2 without the use of a 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 entry port 12 .

The illumination assembly within handpiece 2 projects light into the vaginal barrel. As handpiece 2 is connected to a computer and monitor, and a digital imaging acquisition means for viewing and/or capturing an image is incorporated within handpiece 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 handpiece 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. Also, as the guide member 17 is offset from the central axis of probe 1, it also does not have a large impact on the physician's field of vision. 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. The sealing element 6 has the purpose of providing a seal between the area being examined and that of the handpiece 2, in order to prevent contamination of the latter components. It should be understood that the handpiece 2 of the present embodiment may for instance be purpose built for use with tubular probe and in this embodiment a mounting spigot may not be necessary. Such a handpiece 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 noted that the illuminating assembly within the hand piece may preferably have an ultraviolet capacity and/or an infrared capacity, or any other light from the spectrum which would allow for specialised flouresence examinations of the vagina and 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 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 (or infrared capacity) disposed within handpiece 2, 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 handpiece 2 is connected to tubular probe 1 introduced into the vagina, and in use the handpiece 2 does not move relative to tubular probe 1.

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 in other embodiments also be used to examine other body cavities, and in particular used for rectal examinations. 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 tubular probe 1 thereon.

Also in another not shown embodiment, the size and shape of tubular guide member 14 and entry port 11 of the tubular probe 1 may differ to allow different sized implements to be used with the device. It should also be understood that the relative length of probe 1 at its fore end and the positioning of rib 20 thereon, may differ to that shown in the abovementioned embodiment.

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 handpiece and for allowing a fluid to be introduced into said vagina, 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 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.

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 tubular probe.

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 probe, said tubular guide member having a longitudinal axis that is at an acute angle relative to the longitudinal axis of said probe.

4. An examination device as claimed in claim 3, wherein said probe is adapted to be rotatably moved relative to said handpiece, 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 tubular probe having a second lateral port for introducing fluid into the vagina.

7. An examination device as claimed in claim 1, wherein said handpiece having a port for introducing fluid into said tubular probe.

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

9. 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.

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

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

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

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

14. 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.

15. An examination device as claimed in claim 14, wherein said guide means is a V-shaped member projecting from the inner surface of said tubular probe.

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

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

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

19. An examination device as claimed in claim wherein said fluid introduced into said vagina is air.

20. An examination device for examining a body cavity, said device adapted to be mounted to a handpiece and for allowing a fluid to be introduced into said body cavity, 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 body cavity to reduce egress of fluid therefrom by sealing against a circumferential zone of the internal tissue defining the orifice of said body cavity, characterised in that said tubular probe 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 body cavity, such that said implement may be manipulated by a user.

21. An examination device for examining a vagina, said device adapted to be mounted to a handpiece and for allowing a fluid to be introduced into said vagina, 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 zone of the tissue defining the vaginal orifice, characterised in that said tubular probe 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.

22. An examination device as claimed in claim 21, wherein said handpiece comprises an illumination assembly for illuminating the interior of said vagina.

23. An examination device as claimed in claim 22, wherein the light source from said illumination assembly is light from the spectrum which allows for flouresence examinations of the vagina and cervix.

24. An examination device as claimed in claim 23, wherein said illumination assembly has an ultraviolet capacity and/or an infrared capacity.

25. An examination device for examining the interior of a body cavity, said device adapted to be mounted to a handpiece, 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 zone of the tissue defining the orifice of said body cavity, characterised in that said tubular probe 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 body cavity, such that said implement may be manipulated by a user.