WO2022175799A1

WO2022175799A1 - Medical insertion device

Info

Publication number: WO2022175799A1
Application number: PCT/IB2022/051281
Authority: WO
Inventors: Conrad Sokoundjou TANKOU
Original assignee: Tankou Conrad Sokoundjou
Priority date: 2021-02-19
Filing date: 2022-02-14
Publication date: 2022-08-25

Abstract

A medical insertion device (200) is provided for visualisation of a patient's cervix. The device includes a hollow first tube (202) and a hollow second tube (204) received in the first tube (202), with the second tube (204) having a diameter smaller than a diameter of the first tube (202) to provide a spacing between the first tube (202) and the second tube (204), wherein the second tube (204) is for receiving an image capturing device (218) and the spacing is for receiving a diagnostic tool. A pair of arms (210) is disposed at a terminal end (206) of the device, each arm (210) is movable between an open position, where the arms (210) are spaced apart, and a closed position, where the arms (210) abut each other. A locking mechanism (212) is operable to move and lock the arms (210) at a desired position, wherein at the open position the arms (210) dilate a patient's vaginal walls to provide access to the patient's cervix in use.

Description

MEDICAL INSERTION DEVICE

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims priority from African Intellectual Property Organisation Utility Model application number 2202100005 filed on 19 February 2021 , which is incorporated by reference herein.

FIELD OF THE INVENTION

This disclosure relates to a medical insertion device. More specifically, it relates to a medical insertion device for visualisation of a patient’s cervix.

BACKGROUND

Conventional speculums are prone to discomfort and pain since they are blindly inserted into a patient’s orifice, and a practitioner, based on feel and experience, attempts to position the speculum in an appropriate setting. In doing so, the speculum may be inserted more deeply within the patient’s orifice than necessary or desirable, creating pain and unpleasantness. This may lead to an automatic flexing of internal muscles such that the orifice is involuntarily tightened, in which case the conventional speculum forcibly opens the orifice leading to more unease and irritation.

Further, conventional speculums are associated with manual examinations, and current protocol dictates any results of an examination are memorialized as practitioner's visual observations and any accompanying diagnostic test. As an example, results of a “Pap Smear” examination consist of the practitioner's visual observations and any microbiological, cytological and/or pathological tests. The drawback of this procedure is that it is prone to error. For example, a diagnostic test may reveal a possible malady, but a negative visual observation may lead a practitioner to conclude the test may have been false. On the other hand, the practitioner may observe something peculiar, but may conclude that it is insignificant if a diagnostic test reveals a false negative.

There is a need in the art to address the aforementioned and other problems.

The preceding discussion of the background to the invention is intended only to facilitate an understanding of the present invention. It should be appreciated that the discussion is not an acknowledgment or admission that any of the material referred to was part of the common general knowledge in the art as at the priority date of the application. SUMMARY

In accordance with the technology there is provided a medical insertion device for visualisation of a patient’s cervix comprising: a hollow first tube and a hollow second tube received in the first tube with the second tube having a diameter smaller than a diameter of the first tube to provide a spacing between the first tube and the second tube, wherein the second tube is for receiving an image capturing device and the spacing is for receiving a diagnostic tool; a pair of arms disposed at a terminal end of the device, each arm movable between an open position in which the arms are spaced apart and a closed position in which the arms abut each other; and a locking mechanism operable to move and lock the arms at a desired position, wherein at the open position the arms dilate a patient’s vaginal walls to provide access to the patient’s cervix in use.

A medical insertion device as defined has the advantage of providing a distending mechanism (being the pair of arms) only at the terminal end of the device, which distends only when close to the patient’s cervix in use, causing little or no pressure or discomfort for the patient. It has the advantage in that it may provide a clear and unobstructed view of the patient’s cervix and may permit a diverse list of activities to be performed on the cervix without distending the virginal walls.

Further features provide for the locking mechanism to include a pair of elongate members disposed in the spacing between the first tube and the second tube, each elongate member attached to an arm by an attachment formation configured such that a linear movement of an elongate member translates into a movement of the attached arm. A linear movement of an elongate member away from the terminal end translates into a movement of the attached arm towards the open position and a linear movement of an elongate member towards the terminal end translates into a movement of the attached arm towards the close position. This has the advantage in that the elongate members may be pulled or pushed to open or close the pair of arms.

Further features provide for the tubes to include a tool insertion end and each elongate member extends beyond the tool insertion end, wherein the extension includes a screw thread on its surface for receiving a screw member thereon. The screw member is fixed in relation to the tubes and rotation of the screw member translates into linear movement of the elongate member. The screw member acts to lock the arms at a desired position and the external surface of the screw member is roughed for increase friction and ease of use by a user. This has the advantage in that the screw member may simply be rotated to open or close pair of arms.

Further features provide for each elongate member to be attached to a gripping formation. The gripping formation may be a semi-circular arc attached to the elongate member or an open loop with a passage for a user’s finger therethrough for ease of gripping.

Further features provide for the arms to be semi concave and when in the open position to be spaced apart by a distance in the range of 30mm to 70mm. The first tube may be circular with a diameter of between 15mm and 50mm and preferable a diameter of 25mm. The tubes may have a length of between 120mm and 180mm and preferably 150mm. The first tube may include an external visible mark to indicate to a user that the arms are positioned next to the patient’s cervix in use. A disposable flexible sheath configured to be worn on the device for ease of use. The disposable flexible sheath has the advantage in that it may be easier to insert the device when lubricated, it may permit the device to be easily disinfected after use in areas without autoclave to heat sterilise, since it prevents direct contact of the device with tissue.

The image capturing device may be an endoscope having a camera and a light source, wherein the endoscope is connectable to smart device having a mobile application configured to display captured images and/or transmit the captured images to a remote computing device. The diagnostic tool may include one of swabs, an artificial insemination pipette, a biopsy forceps, and a spraying dispositive to spray a solution unto a patient’s cervix.

In accordance with another aspect of the technology there is provided a kit comprising:

- medical insertion device as described hereinabove;

- an endoscope having a camera and a light source, the endoscope being connectable to a smart device for display of captured images thereof;

- one or more disposable flexible sheaths configured to be worn on the device; and

- a strap for securing a smart device to a user’s wrist.

In accordance with another aspect of the technology there is provided medical insertion device for visualisation of a patient’s cervix comprising: an elongate body having a tool insertion end, an opposite terminal end, and two open ended channels passing therethrough between the tool insertion end and the terminal end, wherein a first channel is for receiving an image capturing device and a second channel for receiving a diagnostic tool; and a pair of arms disposed at the terminal end, each arm movable by a movement mechanism between an open position in which the arms are moved away from each other providing a spacing therebetween, and a closed position in which the arms are moved towards and abuts each other; wherein the movement mechanism includes a locking mechanism configured to keep the arms in the closed position for insertion of the body into a patient’s vagina, and the locking mechanism is configured to keep the arms in the open position to dilate the patient’s vaginal walls to provide access to the patient’s cervix for visualisation thereof.

The movement mechanism may include a pair of elongate members disposed between the tool insertion end and the terminal end, with each elongate member attached to an arm by an attachment formation and each elongate member attached to a gripping formation at the tool insertion end. The attachment formation may be configured such that a longitudinal movement of the elongate member towards the tool insertion end translates into a movement of the attached arm towards the open position and a longitudinal movement of the elongate member towards the terminal end translates into a movement of the attached arm towards the close position. The movement mechanism may be configured such that the arms are independently movable or are movable simultaneously.

The locking mechanism may include a nut attached to an elongate member. The nut may be engageable to keep the corresponding arm in either the open position or the closed position.

The gripping formation may be an open loop with a passage for a user’s finger therethrough for ease of gripping. A loop may be pulled or pushed with a user’s finger to cause a corresponding longitudinal movement of the attached elongate member. Alternatively, the gripping formation may be a trigger operable by a user’s finger. A user may pull or release the trigger to cause a corresponding longitudinal movement of the attached elongate member. The gripping formation may further include a handle for easy gripping and manipulation by a user.

The arms may move away from each other towards the open position to expose an exit of the channels at the terminal end. The medical insertion device may be rotated such that the arms are vertically disposed with one above the other to enable a more focus view of the patient’s cervix. For example, a posterior cervix may be better viewed when an arm is moved upwards towards the open position which may push the cervix upwards. The arms when in the open position may provide a spacing therebetween in the range of 40mm to 70mm. The arms may be semi concave and may include internal reflective surfaces.

The image capturing device may be an endoscope having a camera, a light source with filters to produce lights of different wavelengths and a command control for light intensity adjustment, zooming and taking snapshots. The image capturing device may be connectable to smart device including a smartphone, tablet computer, wearable device or the like and may be connectable to the smart device through a cable or a wireless network. The smart device may have a mobile application configured to display captured images of the image capturing device and/or transmit the images to a remote computing device. The image capturing device may be permanently received in the first channel. An anti-reflective lens, glass or coating may be disposed at the front end of the endoscope to reduce glare.

The diagnostic tool may include swabs, artificial insemination pipette, biopsy forceps, a spraying dispositive to spray a solution unto the cervix for an intended result such as spraying acetic acid solution unto the cervix to screen for cervical cancer and the like. The elongate body may be made of a foldable material. This may imply the size and diameter of the terminal end which is inserted into the patient’s vagina canal may be further reduced.

The body may include an external visible mark for visual indication to a user that the pair of arms are positioned next to the patient’s cervix in use. The body may be circular with a diameter of between 15mm and 50mm and preferable a diameter of 25mm. Smaller diameter designs may enable easy insertion of the medical insertion device through the patient’s vaginal canal and may assure more comfort for the patient.

The medical insertion device may be made of metal including stainless steel, or made of plastic material. A metal device may have the advantage of it being easily sterilisable and a plastic device may have the advantage of it being easily disposable. Some devices may be have some components made up of metal while others made of plastic. Other devices could be made with a reusable plastic material.

A disposable thin flexible lubricated plastic material may be provided at the terminal end of the body to enable easy sterilisation after use.

Embodiments of the invention will now be described, by way of example only, with reference to the accompanying drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

In the drawings:

Figure 1 is a side view of a medical insertion device according to one embodiment of the present disclosure;

Figure 2 is a tool insertion end view of the medical insertion device of Figure 1 ;

Figure 3 is a tool insertion end view of the medical insertion device of Figure 1 with an image capturing device received through the second tube; Figure 4 is a terminal end view of the medical insertion device of Figure 1 with an image capturing device received through the second tube;

Figure 5 is a three-dimensional view of the embodiment of Figure 1 when operable by a user; Figure 6 is a three-dimensional view of a medical insertion device according to one embodiment of the present disclosure; Figure 7 illustrates the pair of elongate members of the locking mechanism with one elongate member moved towards the tool insertion end and the attached arm moved to the open position;

Figure 8 is a view of the tool insertion end with the locking mechanism and gripping formation of the embodiment of Figure 6;

Figure 9 is a three-dimensional view of an arm according to embodiments of the present disclosure;

Figure 10 is a detailed view of the attachment formation attached to each arm according to embodiments of the present disclosure;

Figure 11 is a view of the terminal end with the pair of arms in the open position according to embodiments of the present disclosure;

Figure 12 is a view of the terminal end with the pair of arms in the closed position according to embodiments of the present disclosure;

Figure 13 is a view of a gripping formation according to another embodiment of the present disclosure;

Figure 14 is a detailed view of the gripping formation of Figure 13; Figure 15 illustrate one exemplary embodiment of a medical insertion device with the gripping formation of Figure 13 and the image capturing device being connected to a smart device;

Figure 16 is a three-dimensional view of the embodiment of Figure 15 when operable by a user; Figure 17 is a side section view of the medical insertion device in use according to embodiments of the present disclosure; and

Figure 18 is a block diagram showing various method steps for using the medical insertion device according to embodiments of the present disclosure.

DETAILED DESCRIPTION WITH REFERENCE TO THE DRAWINGS

A medical insertion device is provided for visualisation of a patient’s cervix. The device includes a pair of arms disposed at a terminal end thereof. Each arm is movable between an open position where the arms are spaced apart and a closed position where the arms abut each other. A locking mechanism is operable to move and lock the arms at a desired position. At the open position, the arms dilate the patient’s vaginal walls to provide access to the patient’s cervix in use.

Exemplary embodiments of a medical insertion device are now described in a non-limiting manner with reference to the Figures.

Figures 1 to 5 illustrate one exemplary embodiment of a medical insertion device (200). The medical insertion device (200) includes a circular hollow first tube (202) and a circular hollow second tube (204). The first tube (202) may have a diameter of between 15mm and 50mm and preferable a diameter of 25mm. The second tube has a diameter smaller than a diameter of the first tube to provide a spacing between the first tube (202) and the second tube (204).

The tubes (202, 204) have a terminal end (206) and a tool insertion end (208). A pair of semi concave arms (210) is disposed at the terminal end (206). Each arm (210) is movable between an open position in which the arms (210) are spaced apart and a closed position in which the arms (210) abut each other. When in the open position the arms (210) are spaced apart by a distance in the range of 30mm to 70mm.

A locking mechanism (212) is provided to move and lock the arms (210) at a desired position. The locking mechanism (212) includes a pair of elongate members disposed in the spacing between the first tube (202) and the second tube (204). Each elongate member is attached to an arm (210) by an attachment formation configured such that a linear movement of an elongate member towards the tool insertion end (208) translates into a movement of the attached arm towards the open position and a linear movement of an elongate member towards the terminal end (206) translates into a movement of the attached arm towards the close position.

Each elongate member extends beyond the tool insertion end (208). The extension includes a screw thread on its surface, and a screw member (214) is received on the screw thread. The screw member (214) acts to lock the arms (210) at a desired position and may be fixed in relation to the tubes. Rotation of the screw member (214) translates into linear movement of the elongate member. The external surface of the screw member (214) is roughed for increase friction and ease of use by a user.

Each elongate member is attached to a gripping formation (216). In the illustrated embodiment, the gripping formation is a semi-circular arc attached to the elongate member. In another embodiment, the gripping formation is an open loop with a passage for a user’s finger therethrough for ease of gripping.

An image capturing device (218) may be received in the second tube (204). In the illustrated embodiment, the image capturing device (218) is an endoscope having a camera and a light source. The light source may provide light of different wavelengths e.g., white light or green light. Green light may have the advantage in that the images of the patient’s cervix are more vascularised. The endoscope is connectable to smart device (220) having a mobile application configured to display captured images and/or transmit the captured images to a remote computing device.

A diagnostic tool may be received in the spacing between the first tube (202) and the second tube (204). The diagnostic tool may include one of swabs, an artificial insemination pipette, a biopsy forceps, and a spraying dispositive to spray a solution unto a patient’s cervix.

The medical insertion device is made of metal including stainless steel. A metal device may have the advantage of it being easily sterilisable. A disposable flexible sheath (222) is provided and configured to be worn on the medical insertion device. The disposable flexible sheath (222) has the advantage in that it may be easier to insert the device when lubricated, it may permit the device to be easily disinfected after use in areas without autoclave to heat sterilise, since it prevents direct contact of the device with tissue. Further, disposable flexible sheath may prevent the patient not to feel the metal coldness of the medical insertion device when being inserted which is a usual cause of discomfort.

A kit may be provided for visualisation of a patient’s cervix. The kit may include one or more medical insertion devices of different sizes, an endoscope having a camera and a light source, the endoscope being connectable to a smart device for display of captured images thereof, one or more diagnostic tools, one or more disposable flexible sheath to be worn on the medical insertion device and a strap for securing a smart device to a user’s wrist.

In use, smart device (220) is strapped to the wrist of the user. The endoscope is connected to the smart device (220). The disposable flexible sheath (224) is worn on the medical insertion device, and the endoscope is inserted through the second tube (204). The sheath (224) is lubricated with a suitable lubricant and the device is inserted into the patient’s vagina with the arms (210) of the device in a closed position. Once inserted, the locking mechanism is operated to move the arms (210) to the open position which dilates the patient’s vaginal walls providing access to the patient’s cervix. Appropriate images of the cervix may then be obtained.

Figures 6 to 12 illustrate one exemplary embodiment of a medical insertion device (10). The medical insertion device (10) includes a circular elongate body (12) with a diameter of between 15mm and 50mm and preferable a diameter of 25mm. The elongate body (12) has a tool insertion end (14), an opposite terminal end (16). Two open ended channels (18, 20) passes through the entire length of the body (12) between the tool insertion end (14) and the terminal end (16). A first channel (18) is for receiving an image capturing device therethrough and a second channel (20) is for receiving a diagnostic tool therethrough.

A pair of concave shaped arms (22, 24) is disposed at the terminal end (16). Each arm (22, 24) is movable between an open position in which the arms (22, 24) are moved away from each other providing a spacing therebetween, and a closed position in which the arms (22, 24) are moved towards and abuts each other. The arms (22, 24) when in the open position provides a spacing therebetween in the range of 40mm to 70mm and are configured to dilate the patient’s vaginal walls to provide access to the patient’s cervix for visualisation thereof. The arms may have internal reflective surfaces for reflecting light from the image capturing device for enhance visualisation of the patient’s cervix. The elongate body (12) may include an external visible mark (26) for visual indication to a user that the pair of arms (22, 24) are positioned next to the patient’s cervix in use.

A movement mechanism is connected to each arm (22, 24) and is configured to move each arm between the open position and the closed position. The movement mechanism includes a pair of elongate members (28, 30) disposed between the tool insertion end (14) and the terminal end (16). Each elongate member (28, 30) is attached to an arm (22, 24) by an attachment formation (32) as more fully shown in Figure 10. The attachment formation (32) is configured such that longitudinal movement of each elongate member (28, 30) towards the tool insertion end (14) translates into movement of the attached arm (22, 24) towards the open position and longitudinal movement of each elongate member (28, 30) towards the terminal end (16) translates into a movement of the attached arm (22, 24) towards the close position. In some embodiments, the movement mechanism is configured such that the arms (22, 24) are independently movable or are movable simultaneously.

The movement mechanism includes a locking mechanism in this embodiment a pair of nuts (34, 36) attached to an elongate member. The nuts may be engageable to keep the arms (22, 24) in the closed position for insertion of the elongate body (12) into a patient’s vagina, and to keep the arms (22, 24) in the open position to dilate the patient’s vaginal walls to provide access to the patient’s cervix for visualisation thereof.

Each elongate member (28, 30) is attached to a gripping formation (38) at the tool insertion end (14). In this embodiment, the gripping formation (38) is an open loop with a passage for a user’s finger therethrough for ease of gripping as more fully shown in Figures 6 to 8. The loop may be pulled or pushed with the user’s finger to cause a corresponding longitudinal movement of the attached elongate member (28, 30). As can be seen in Figure 7, the arms are independently movable with one elongate member (28) moved towards the tool insertion end and the attached arm (22) moved to the open position.

Figures 13 to 16 illustrate one exemplary embodiment of a medical insertion device (60) with an alternative gripping formation (62). In this embodiment, the gripping formation (62) is a trigger operable by a user’s finger and the arms (22, 24) are movable simultaneously. The user may pull or release the trigger to cause a corresponding longitudinal movement of the attached elongate members (28, 30). The gripping formation (62) further includes a handle (64) for easy gripping and manipulation by the user.

In this embodiment, the image capturing device (66) is an endoscope having a camera, a light source with filters to produce lights of different wavelengths and a command control for light intensity adjustment, zooming and taking snapshots. The endoscope is connected to smart device (68) such as a smartphone, through a cable (70). The image capturing device (66) is permanently received in the first channel (18) and an anti-reflective lens, glass or coating is disposed at the front end thereof to reduce glare. A strap (72) is provided to permit the smart device (68) to be securely attached to the wrist of the user, permitting images relayed by the endoscope camera to be easily seen by the user, and enabling the user to easily manipulate the smart device (68) with his/her other hand, if need be, as shown in Figures 15 and 16.

The smart device (68) may include a mobile application with the capacity to capture images of the anatomical area brought under focus by the endoscope camera at any point in time, and further store the images locally or transmit the images to be stored in a secured cloud platform. The images can then be displayed or shared with other users. Images can therefore be viewed and analysed onsite, on in a distant site by a competent medical practitioner.

In use, as shown in Figure 18, the endoscope is connected (102) to the smartphone. The medical practitioner may register (104) a patient using the mobile application on the smartphone. The smartphone is then strapped (106) to the wrist of the user and the endoscope camera is connected. The terminal end of the medical inspection device is lubricated and inserted (108) into the patient’s vagina when the arms are in the closed position. The arms are then moved to the open position (110) for digital visualisation of a patient’s cervix and the first set of images or videos are captured (112). Acetic acid-soaked swab (114a) or a Lugol’s Iodine soaked swab (114b) is inserted through the second channel and another set of images or videos is captured (116a, 116b) about a minute or two after. The images or videos is then sent (118) to a medical specialist and the specialist may send feedback instantly (120).

Cervical cancer which is preventable and easily treated when detected at early stages ranks as either the first or second most common cancer in Sub-Sahara African countries. Approximately 85% of cervical cancer cases worldwide occur in low- and middle-income countries (LMIC) mainly due to the lack of awareness, lack of efficient primary and secondary prevention programs, lack of skilled health professionals especially in rural areas to perform screening activities, target women reluctant to get screened due to fear of some of the tools used notably the speculum. The cervical cancer incidence in sub-Saharan Africa is approximately 31.5 per 100,000 women, accompanied by a mortality rate of approximately 17.9 per 100,000 women, which makes cervical cancer the most common cancer and the most common cause of cancer-related death among African women. The recommended screening approach in LMIC for cervical cancer is visual inspection of the cervix after the application of acetic acid (VIA) and is often followed by the application of Lugol’s iodine (VILI). Visual inspection methods are simple, inexpensive and require minimal infrastructure, allowing patients to be screened and treated within the same-day session. In addition, human resources may not be readily available, particularly if health facilities are located in remote, hard-to-reach areas.

The conventional speculum which was invented several years ago attempts to alleviate the abovementioned problems. However, little innovation has been done on its design over the years to make it more comfortable when used. The speculum has two bills which are cured on the front aspect, and when inserted into the patient’s vaginal, permit the vaginal walls to be expanded wide to permit direct visualisation and access to the cervix. There are no set industry standards for speculae size, and manufacturers vary in their categorization. As a general principle, the wider the speculum, the greater the potential for patient discomfort in speculum insertion and opening, whereas the narrower the speculum, the more limited the visualization.

The conventional speculum, in some cases, does not allow for complete visualization of the cervix because of its design and frequently causes a lot of patient discomfort. One of the most common limitations is the frequent occurrence of lateral vaginal wall collapse, which almost completely blocks viewing of the cervix, and this problem is faced by almost every health professional. In addition, the current speculum design is difficult to be inserted in an anxious or fearful woman.

Particular cases where speculum examination is usually challenging for the examiner and very uncomfortable and even painful for the patient includes: adolescent and menopausal women, sexual minorities, obese women, women with disabilities, women with a history of trauma or prior instrumentation affecting the genitalia, and women who are victims of sexual violence, a tendency which is very rampant in developing countries. Speculum examination can become painful in postmenopausal women with vulvovaginal atrophy. Vaginal atrophy, shortening, and stenosis with reduced elasticity are also common findings, and render speculum examination impossible, uncomfortable and even painful. Women who have experienced physical or sexual trauma are often particularly uncomfortable with speculum insertion which may reawaken memories and flashbacks, and especially for women with vaginismus, a condition involving the involuntary tightening of the vagina often caused by sexual abuse. This can be easily understood because distending the introitus causes discomfort or pain in most women, especially non-parous women, aged women with retracted vagina walls, and women who have been sexually abused recently or not. Many women have described the speculum examination experience as a personalise tutoring experience causing anxiety, fear, discomfort, and pain, and many shun away from important medical procedures requiring the speculum such as cervical cancer screening. And considering that screening is not just a once in a lifetime requirement, this has been one of the leading causes of nonadherence to screening over the years.

Little attention has focused on the mechanics of pelvic examination technique, yet the examination is an intrusive experience for many women who feel exposed and lack control. Emotional distress and fear of pain are cited as reasons for reduced adherence to cervical screening linked to the speculum. In addition, some health professionals attest that lighting when using a speculum is insufficient and inefficient. One other key problem linked with the use of a conventional speculum is that, in fat women especially, after the speculum has been inserted, the vaginal walls collapse inwards through the open sides of the speculum, leading to obstruction in viewing the cervix properly. Therefore, in such cases, activities such as visual screening for cervical cancer becomes very limited and often impossible.

A colposcope is used by some developed countries to visualise the cervix, and this is possible only after inserting a vaginal speculum. The colposcope is relatively expensive and often not affordable in developing settings. This adds onto the problem of providing cervical cancer screening in developing settings considering the limitations of using a regular speculum, and the unavailability of colposcopes.

The technology described in the present application aims to alleviate the abovementioned problems at least to some extent. It has the advantage in that it may provide an image-based system that could capture images from the point of care and transmit to Medical Specialists in real time for analysis and diagnosis remotely of cervical pre-cancer and cancer. This may represent an important step toward the improvement of cervical cancer screening and early detection at the point of care. It has the advantage in that it may provide a small device with a diameter of 25mm enabling easy entry through the introitus without distending the vaginal walls extensively compared to the speculum and has a distending mechanism (being the arms) only at the tip which distends only in when close to the cervix, with a distending distance of about 60mm, causing little or no pressure or discomfort for the patient. It has the advantage in that it may provide a clear and unobstructed view of the patient’s cervix and may permit a diverse list of activities to be performed on the cervix without distending the virginal walls, including viewing for any lesions, screening through visual inspection, tacking a sample for PAP smear, and/or doing a biopsy. Further, sharing images with remote experts in real time allows health care providers to obtain advice and to improve their work’s quality. Yet further, digital images can be used for quality control as well as, for continuous education in e-learning platforms to help students across the globe to practice interpretation of VIA/VILI. Even further, the device may be used with other endoscopic procedures, including bronchoscopy, colonoscopy, and sigmoidoscopy, as well as application in the field of veterinary medicine for invitro fertilisation procedures, and others.

The technology described in the present application may therefore provide a cost-effective device which adapts to the concept of developing settings, enabling screening of cervical cancer to be brought to community level.

Application for artificial insemination in veterinary medicine

Taking an animal such as a cow as case study, the current artificial insemination is done using the recto-vaginal method. This method involves cleaning of the external genitalia with disposable towelling, then introducing a gloved hand into the rectum and grasping the cervix. An insemination pipette is introduced through the vulva and vagina to the external cervical OS. By manipulating the cervix, along with the light cranial pressure on the pipette, the pipette is advanced through the annular ring of the cervix to the junction of the internal cervical OS and the body of the uterus. The semen is then deposited slowly to avoid sperm loss. The process is completely a manual and blind procedure as there is no possibility at all to visualise the internal canal nor monitor the procedure interiorly visually. Consequently, the rate of failure is extremely high, and also linked to the experience of the manipulator.

The technology described in the present application provides for two open ended channels, a first channel which can receive the endoscope therethrough and a second channel which can receive the insemination pipette or swop collector, or any other diagnostic tool therethrough. The endoscope is linked directly to a smartphone which is attached at the level of the user’s wrist to ease viewing of the imaging being captured by the smartphone. The insemination pipette may be connected to a graduated trigger system which may facilitate the deposition of semen. The technology described in the present application may provide for diseased conditions detection; less trauma to the animal with respect to the restraint methods and rectal examinations done to grasp the cervix; increase precision for the semen deposit in the cervix, significantly increasing success rates; less time being used for this procedure; and the ability to screen and document pathologies of the vaginal canal up to cervix.

Using the technology, the medical practitioner can have a clear vision of the trajectory from the vagina to the cervix and through and may help the practitioner to detect any disease condition. The pathway from the vagina to the cervix can be seen, thus giving the medical practitioner a clear vision of where the semen is going to be expelled and hence and increase precision. The foregoing description has been presented for the purpose of illustration; it is not intended to be exhaustive or to limit the invention to the precise forms disclosed. Persons skilled in the relevant art can appreciate that many modifications and variations are possible in light of the above disclosure. The language used in the specification has been principally selected for readability and instructional purposes, and it may not have been selected to delineate or circumscribe the inventive subject matter. It is therefore intended that the scope of the invention be limited not by this detailed description, but rather by any claims that issue on an application based hereon. Accordingly, the disclosure of the embodiments of the invention is intended to be illustrative, but not limiting, of the scope of the invention.

Finally, throughout the specification and accompanying claims, unless the context requires otherwise, the word ‘comprise’ or variations such as ‘comprises’ or ‘comprising’ will be understood to imply the inclusion of a stated integer or group of integers but not the exclusion of any other integer or group of integers.

Claims

CLAIMS:

1 . A medical insertion device for visualisation of a patient’s cervix comprising: a hollow first tube and a hollow second tube received in the first tube with the second tube having a diameter smaller than a diameter of the first tube to provide a spacing between the first tube and the second tube, wherein the second tube is for receiving an image capturing device and the spacing is for receiving a diagnostic tool; a pair of arms disposed at a terminal end of the device, each arm movable between an open position in which the arms are spaced apart and a closed position in which the arms abut each other; and a locking mechanism operable to move and lock the arms at a desired position, wherein at the open position the arms dilate a patient’s vaginal walls to provide access to the patient’s cervix in use.

2. The medical insertion device as claimed in claim 1 , wherein the locking mechanism includes a pair of elongate members disposed in the spacing between the first tube and the second tube, each elongate member attached to an arm by an attachment formation configured such that a linear movement of an elongate member translates into a movement of the attached arm.

3. The medical insertion device as claimed in claim 2, wherein a linear movement of an elongate member away from the terminal end translates into a movement of the attached arm towards the open position and a linear movement of an elongate member towards the terminal end translates into a movement of the attached arm towards the close position.

4. The medical insertion device as claimed in claim 2 or claim 3, wherein the tubes include a tool insertion end and each elongate member extends beyond the tool insertion end, wherein the extension includes a screw thread on its surface for receiving a screw member thereon.

5. The medical insertion device as claimed in claim 4, wherein a screw member is received on the screw thread and rotation of the screw member translates into linear movement of the elongate member.

6. The medical insertion device as claimed in claim 4 or claim 5, wherein the screw member acts to lock the arms at a desired position.

7. The medical insertion device as claimed in any one of claims 4 to 6, wherein an external surface of the screw member is roughed for increase friction and ease of use by a user.

8. The medical insertion device as claimed in any one of claims 2 to 7, wherein each elongate member is attached to a gripping formation.

9. The medical insertion device as claimed in claim 8, wherein the gripping formation is a semi-circular.

10. The medical insertion device as claimed in claim 8, wherein the gripping formation is an open loop with a passage for a user’s finger therethrough for ease of gripping.

11 The medical insertion device as claimed in any one of the preceding claims, wherein the arms are semi concave and when in the open position are spaced apart by a distance in the range of 30mm to 70mm.

12. The medical insertion device as claimed in any one of the preceding claims, wherein the first tube is circular with a diameter of between 15mm and 50mm and preferable a diameter of 25mm.

13. The medical insertion device as claimed in claim any one of the preceding claims, wherein the image capturing device is an endoscope having a camera and a light source, wherein the endoscope is connectable to smart device having a mobile application configured to display captured images and/or transmit the captured images to a remote computing device.

14. The medical insertion device as claimed in claim any one of the preceding claims, wherein the diagnostic tool includes one of swabs, an artificial insemination pipette, a biopsy forceps, and a spraying dispositive to spray a solution unto a patient’s cervix.

15. The medical insertion device as claimed in claim any one of the preceding claims, wherein the first tube includes an external visible mark to indicate to a user that the arms are positioned next to the patient’s cervix in use.

16. The medical insertion device as claimed in claim any one of the preceding claims, further including a disposable flexible sheath configured to be worn on the device for ease of use.

17. A kit comprising: - medical insertion device as claimed in any one of claims 1 to 16;

- one or more disposable flexible sheaths configured to be worn on the device; and - a strap for securing a smart device to a user’s wrist.