Abstract: ABSTRACT SYSTEM AND METHOD FOR EXAMINATION OF A VAGINAL CAVITY AND CERVIX OF A HUMAN BODY The system (100) includes an examination device (10), a support stand (30) and a device (40). The examination device (10) has a head portion (11) rotatably and linearly adjustable. The support stand (30) supports the examination device (10) and provides clear images and reduces examination time. The examination devices (10) includes both a radial imaging unit (15) and an axial examination unit (16) that captures radial images/videos to capture walls of the vaginal cavity and axial images/videos to capture of the cervix. Further, the examination device has a first light source (17) that emanates white light and a second light source (18) that emanates colored light having wavelength ranging from 400nm to 500nm. The device (40) has a processing unit (44) that analyses captured images and/or videos and provide a three dimensional map depicting abnormalities. (To be published with Figure 1)
Claims:We Claim:
1) A system (100) for examination of a vaginal cavity and a cervix of a human body, said system (100) comprising:
• an examination device (10) defined with a head portion (11) and a body portion (12), said head portion (11) removably introducible in the vaginal cavity,
said head portion (11) and said body portion (12) connected by:
a linear joint (13) for linear extension and retraction of said head portion (11) with respect to said body portion (12), and
a rotational joint (14) for angular adjustment of said head portion (11) with respect to said body portion (12);
said head portion (11) defined with:
o at least one radial imaging unit (15) disposed on the circumferential portion (11a) of said head portion (11) for radial examination of the walls of the vaginal cavity by capturing at least one image and/or at least one video;
o at least one axial imaging unit (16) disposed at the tip of said head portion (11) for axial examination of the cervix by capturing at least one image and/or at least one video;
o at least one first light source (17) illuminating white light, said first light source (17) positioned in the vicinity of said radial imaging unit (15) and said axial imaging unit (16);
o at least one second light source (18) illuminating at least one color light and having wavelength ranging from 400 to 500nm, said second light source (18) positioned in vicinity of said radial imaging unit (15) and said axial imaging unit (16);
o a power source (19) disposed inside said body portion (12) and in wired connection with said first light source (17), said second light source (18), said radial imaging unit (15) and said axial imaging unit (16);
o at least one switch (20) disposed on a surface of said body portion (12) to operate said first light source (17), said second light source (18), said radial imaging unit (15) and said axial imaging unit (16) through a control panel (21); and
o at least one spray unit (22) detachably connected to said head portion (11) and configured to spray at least one agent in the vaginal cavity and/or the cervix;
• a support stand (30) for selectively holding and adjusting said examination device (10);
• a device (40) comprising:
o a display screen (41) in removable connection with said radial imaging unit (15) and said axial imaging unit (16) of said examination device (10) to display at least one image and/or video captured by said radial imaging unit (15) and said axial imaging unit (16);
o a storage unit (42) configured to store at least one threshold data and captured at least one image and/or video;
o an input unit (43) to select desired at least one image and/or video displayed on said display screen; and
o a processing unit (44) in connection with said radial imaging unit (15) and said axial imaging unit (16) and configured to perform:
? calculation of at least one feature for each captured image and/or video;
? image registration for each image and/or video by assuming a reference center point;
? group images and/or videos having similar optical properties;
? compare abnormal and normal areas to find regions with neoplastic tissue;
? analyze the regions for the probability of abnormality using a reference threshold stored in said storage unit (42); and
? generate a three dimensional disease probability map.
2) The system (100) as claimed in claim 1, wherein said processing unit (44) further includes removal of impulse noise spikes, specular reflection and blood traces from the captured image(s) and/or video(s).
3) The system (100) as claimed in claim 1, wherein said radial imaging unit (15) and said axial imaging unit (16) configured to capture image(s) and/or video(s) before and after application of at least one agent from at least one spray unit.
4) The system (100) as claimed in claim 1, wherein said image registration is performed by selecting cervix OS as a reference point.
5) The system (100) as claimed in claim 1, wherein said captured image(s) and/or video(s) and/or processed image(s) and/or video(s) are transmitted to a remotely positioned device.
6) A method for examination of a vaginal cavity and a cervix of a human body, said method comprising:
o providing an examination device (10) defined with a head portion (11) and a body portion (12);
o clamping and adjusting said examination device (10) on a support stand (30);
o adjusting, selectively, a rotational joint (14) to achieve at least one desired angle of said head portion (11) with respect to said body portion (12);
o adjusting, selectively, a linear extension (13) to achieve extension and retraction of said head portion (11) with respect to said body portion (12) and at least one desired length;
o introducing said head portion (11) in the vaginal cavity;
o operating at least one switch (20) to trigger a power source (19) through a control panel (21) and thereby activate:
• at least one first light source (17) emitting white light of at least one pre-defined color and at least one first pre-defined wavelength;
o capturing at least one of: at least one image and at least one video by at least one radial imaging unit (15) and at least one axial imaging unit (16) in presence of the white light, wherein said at least one radial imaging unit (15) is disposed on the circumferential portion of said head portion (11) for radial examination of the walls the vaginal cavity and said axial imaging unit (16) is disposed at the tip of said head portion (11) for axial examination of the cervix;
o operating at least one switch (20) to trigger a power source (19) through a control panel (21) and thereby activate:
• at least one second light source (18) emitting at least one color light having wavelength ranging from 400 to 500nm;
o capturing at least one of: at least one image and at least one video by said radial imaging unit (15) and said axial imaging unit (16) in presence of the at least one color light having wavelength ranging from 400 to 500nm;
o spraying from a spray unit (22) at least one first agent in the vaginal cavity;
o capturing at least one of: at least one image and at least one video by said radial imaging unit (15) and said axial imaging unit (16) in presence of the at least one of: the white light and the at least one color light having wavelength ranging from 400 to 500nm;
o spraying from said spray unit (22) at least one second agent in the vaginal cavity;
o capturing at least one of: at least one image and at least one video by said radial imaging unit (15) and said axial imaging unit (16) in presence of the at least one of: the white light and the at least one color light having wavelength ranging from 400 to 500nm;
o viewing, captured images and/or videos for observation;
o processing the images and/or videos in a processing unit (44), said processing steps includes:
• calculating at least one feature for each image and/or video;
• performing image registration for each image and/or video by assuming a reference center point;
• grouping images and/or videos having similar optical properties;
• comparing abnormal and normal areas to find regions with neoplastic tissue;
• analyzing the regions for the probability of abnormality using a reference threshold stored in a storage unit (42); and
• generating a three dimensional disease probability map.
7) The method as claimed in claim 6, further comprises the step of editing the captured images and/or videos during the step of viewing and observing.
8) The method as claimed in claim 6, further comprises the step of sharing remotely:
o the captured images and/or videos during the step of viewing and observing; and/or
o the three dimensional disease probability map.
9) The method as claimed in claim 6, further comprises the step of processing the images and videos include the step of removing noise spikes, reflection and blood marks.
10) The method as claimed in claim 6, wherein the reference center point is a cervical OS.
11) The method as claimed in claim 6, wherein the step of calculating at least one feature includes:
o RGB intensity values;
o ratio of each RGB intensity value;
o differences in each RGB value;
o differences in each RGB intensity ratio; and
o difference in grey scale intensity values.
12) The method as claimed in claim 6, wherein the step of grouping with similar optical properties includes:
o intensity values of red, green and blue channels;
o ratio of intensity of green channel to that in red channel
o changes in grey scale intensities.
DATED THIS 5th day of July, 2019
GARGI PHADATARE
(IN/PA/2209)
PATENT AGENT OF APPLICANT
, Description:
FORM – 2
THE PATENTS ACT, 1970
(39 of 1970)
&
THE PATENTS RULES, 2003
COMPLETE SPECIFICATION
(See section 10 and rule 13)
SYSTEM AND METHOD FOR EXAMINATION
OF A VAGINAL CAVITY AND A CERVIX
OF A HUMAN BODY
PRO HEALTHCARE SCIENTIFIC PRIVATE LIMITED
AN INDIAN COMPANY OF
C204, Hill Side Apartment, Lane No. 4,
Ramtekadi Industrial Estate, Hadapsar, Pune
State: Maharashtra,
Country: India, Pin Code: 411028
The following specification particularly describes the invention and the manner in which it is to be performed.
FIELD
[001] The present disclosure relates to a system and method for examination of a cavity of a human body. Particularly, the present disclosure relates to a system and method for examination of a vaginal cavity and a cervix of a woman.
BACKGROUND
[002] Conventionally, the cervical examination is done by introducing speculum to increase the size of the opening followed by a visual inspection by a doctor. However, the use of speculum causes discomfort to the person undergoing examination and for visual examination one needs to be dependent on physically present skilled and specialized doctors. Conventional cervical examination devices are available however they are rigid and have non-adjustable bodies. Also, conventional cervical examination devices need to be held in hand which may not give clear viewing and increase examination time. Further, conventional cervical devices cannot capture vaginal cavity and the cervix together and hence may not provide desired view for examination. Also, reagents/agent needs to be manually applied and hence the conventional cervical examination devices need to be frequently removed that causes discomfort.
[003] Hence, there is a need for a system and method for vaginal and cervical examination that can alleviate some of the above-mentioned drawbacks.
OBJECTS
[004] Some of the objects of the arrangement of the present disclosure are aimed to ameliorate one or more problems of the prior art or to at least provide a useful alternative and are listed herein below.
An object of the present disclosure is to provide a system for vaginal cavity and cervix examination of a human body that is of smaller size for easily introducing the vaginal cavity and captures, at an instance, various images and/or videos of the walls of the vaginal cavity and cervix thus providing complete picture for analysis for example examining vaginal cavity and cervix walls at the same time.
Another object of the present disclosure is to provide a system for vaginal cavity and cervix examination of a human body that is connected to a processing unit that processes and analyses images and/or videos and provide analyzed result with less human intervene.
Still another object of the present disclosure is to provide a system for vaginal cavity and cervix examination of a human body that is held on a support stand that provides clear image and/or video capturing and thereby reduces the examination time.
Yet another object of the present disclosure is to provide a system for vaginal cavity and cervix examination of a human body that sends captured images and/or videos to at least one remotely positioned device so that an expert advice is achieved.
Another object of the present disclosure is to provide a system for vaginal cavity and cervix examination of a human body that does not require the need of speculum for enlarging the opening of the cavity.
Still another object of the present disclosure is to provide a system for vaginal cavity examination of a human body that includes at least one spray unit that sprays at least one reagent/agent and hence prevents the need to remove the inserted examination device.
Yet another object of the present disclosure is to provide a system for vaginal cavity and cervix examination of a human body that illuminates cavity with white light as well as at least one color light having wavelength ranging from 400 to 500nm that produces auto tissue fluorescence and helps with the detection of abnormalities that are not visible under white light.
An object of the present disclosure is to provide a system for vaginal cavity and cervix examination of a human body that may not require skilled doctor to perform examination.
Still another object of the present disclosure is to provide a method for vaginal cavity and cervix examination of a human body that easily examines and analyses in less time and efforts.
Other objects and advantages of the present disclosure will be more apparent from the following description when read in conjunction with the accompanying figures, which are not intended to limit the scope of the present disclosure.
SUMMARY
[005] The present disclosure discloses a system for vaginal cavity and cervix examination of a human body, in accordance with one embodiment of the present disclosure. The system includes an examination device, a support stand and a device. The examination device is defined with a head portion and a body portion. The head portion is removably introducible in the vaginal cavity. The head portion and the body portion are connected by a linear joint and a rotational joint. The linear joint is provided for linear extension and retraction of the head portion with respect to the body portion. The rotational joint is provided for angular adjustment of the head portion with respect to the body portion. The head portion includes at least one radial imaging unit, at least one axial imaging unit, at least one first light source, at least one second light source, a power source, at least one switch and at least one spray unit. The radial imaging unit is disposed on the circumferential portion of the head portion for radial examination of the walls of the vaginal cavity by capturing at least one image and/or at least one video. The axial imaging unit is disposed at the tip of the head portion for axial examination of the cervix by capturing at least one image and/or at least one video. The first light source illuminates white light. The first light source is positioned in the vicinity of the radial imaging unit and the axial imaging unit. The second light source illuminates at least one color light and having wavelength ranging from 400 to 500nm. The second light source is positioned in vicinity of the radial imaging unit and the axial imaging unit. The power source is disposed inside the body portion and in wired connection with the first light source, the second light source, the radial imaging unit and the axial imaging unit. The switch is disposed on a surface of the body portion to operate the first light source, the second light source, the radial imaging unit and the axial imaging unit through a control panel. The spray unit is detachably connected to the head portion and configured to spray at least one agent/reagent in the vaginal cavity and cervix. The support stand selectively holds and adjusts the examination device. The device includes a display screen, a storage unit, an input unit and a processing unit. The display screen is removable connected with the radial imaging unit and the axial imaging unit of the examination device to display at least one image and/or video captured by the radial imaging unit and the axial imaging unit. The storage unit stores at least one threshold data and captured at least one image and/or video. The input unit selects desired at least one image and/or video displayed on the display screen. The processing unit in connection with the radial imaging unit and the axial imaging unit and performs:
? calculation of at least one feature for each captured image and/or video;
? image registration for each image and/or video by assuming a reference center point;
? group images and/or videos having similar optical properties;
? compare abnormal and normal areas to find regions with neoplastic tissue;
? analyze the regions for the probability of abnormality using a reference threshold stored in said storage unit (42); and
? generate a three dimensional disease probability map.
The present disclosure also discloses a method for vaginal cavity and cervix examination of a human body, in accordance with one embodiment of the present disclosure. The method includes:
• providing an examination device defined with a head portion and a body portion;
• clamping and adjusting the examination device on a support stand;
• adjusting, selectively, a rotational joint to achieve at least one desired angle of the head portion with respect to the body portion;
• adjusting, selectively, a linear extension to achieve extension and retraction of the head portion with respect to the body portion and at least one desired length;
• introducing the head portion in the vaginal cavity;
• operating at least one switch to trigger a power source through a control panel and thereby activate:
? at least one first light source the emitting white light of at least one pre-defined color and at least one first pre-defined wavelength;
• capturing at least one of: at least one image and at least one video by at least one radial imaging unit and at least one axial imaging unit in presence of the white light, wherein the at least one radial imaging unit is disposed on the circumferential portion of the head portion for radial examination of the walls of the vaginal cavity and the axial imaging unit is disposed at the tip of the head portion for axial examination of the cervix;
• operating at least one switch to trigger a power source through a control panel and thereby activate:
? at least one second light source emitting at least one color light having wavelength ranging from 400 to 500nm;
• capturing at least one of: at least one image and at least one video by the radial imaging unit and the axial imaging unit in presence of the at least one color light having wavelength ranging from 400 to 500nm;
• spraying from a spray unit at least one first agent in the vaginal cavity;
• capturing at least one of: at least one image and at least one video by the radial imaging unit and the axial imaging unit in presence of the at least one of: the white light and the at least one color light having wavelength ranging from 400 to 500nm;
• spraying, from the spray unit, at least one second agent in the vaginal cavity;
• capturing at least one of: at least one image and at least one video by the radial imaging unit and the axial imaging unit in presence of the at least one of: the white light and the at least one color light having wavelength ranging from 400 to 500nm;
• viewing, captured images and/or videos for observation;
• processing the images and/or videos in a processing unit, the processing steps includes:
? calculating at least one feature for each image and/or video;
? performing image registration for each image and/or video by assuming a reference center point;
? grouping images and/or videos having similar optical properties;
? comparing abnormal and normal areas to find regions with neoplastic tissue;
? analyzing the regions for the probability of abnormality using a reference threshold stored in a storage unit; and
? generating a three dimensional disease probability map.
BRIEF DESCRIPTION OF ACCOMPANYING DRAWINGS
[006] A system and method for vaginal cavity and cervix examination of a human body of the present disclosure will now be described with the help of the accompanying drawings, in which:
Figure 1 illustrates a schematic representation of a system for examination of a vaginal cavity and cervix of a human body, in accordance with one embodiment of the present disclosure;
Figure 2 illustrates a schematic representation of an examination device of the system of Figure 1;
Figure 3 illustrates a perspective view of a support stand holding the examination device of Figure 2;
Figure 4 illustrates an architecture of the system of Figure 1; and
Figure 5 illustrates a flowchart of a method for examination of a vaginal cavity and cervix by the system of the Figure 1.
DETAILED DESCRIPTION
[007] Referring now to the drawings, Figures 1-5, where the present invention is generally referred to with numeral (100), it can be observed that a system for vaginal cavity and cervix examination of a human body, in accordance with one embodiment, and includes an examination device (10), a support stand (30) and a device (40).
[008] The examination device (10) is defined with a housing that includes a head portion (11) and a body portion (12) which is also known as a handle portion. The head portion (11) and the body portion (12) house various components of the examination device (10). The head portion (11) and the body portion (12) are connected to each other by a linear joint (13) and a rotational joint (14). The rotational joint (14) permits rotation of the head portion (11). In one embodiment, the rotational joint (14) has two degree of freedom. The linear joint (13) is provided to adjust the overall length of the examination device (10) which facilitates easy insertion into the cavity. As desired, the length between the head portion (11) and the body portion (12) can be increased or decreased by manipulating the linear joint (13) and thereby significantly increases the total internal area of the cavity for examination. Typically, the linear extension has one degree of freedom. Thus, the linear joint (13) and the rotational joint (14) facilitate easy handling of the examination device (10) during examination. In one embodiment, the rotational joint (14) and the linear joint (13) are manually manipulated. In another embodiment, the rotational joint (14) and the linear joint (13) are automatically manipulated by providing necessary mechanical mechanism, hydraulic mechanism or pneumatic mechanism or combination of mechanisms thereof such as electromechanical mechanisms.
[009] The head portion (11) is introduced in the vaginal cavity for the cervix examination of the human body. In one embodiment, the head portion (11) is circular shaped having diametric size approximately 10mm. The head portion (11) houses a radial imaging unit (15), an axial imaging unit (16), at least one first light source (17), at least one second light source (18) and at least one spray unit (22). The radial imaging unit (15) is disposed on the circumferential portion (11a) of the head portion (11) for radial examination of the walls of the vaginal cavity by capturing at least one image and/or at least one video. The axial imaging unit (16) is disposed at the tip (11b) of one or either side of the head portion (11) for axial examination of the cervix by capturing at least one image and/or at least one video. Typically, the use of both the radial imaging unit (15) and the axial imaging unit (16) captures images and/or videos of the cervix and the vaginal wall and thereby provides holistic view for analysis. In one embodiment, the radial imaging unit (15) and the axial imaging unit (16) is covered by a transparent cap (not illustrated in Figures) to protect the radial imaging unit (15) and the axial imaging unit (16) and allow capturing images/videos therethrough. The radial imaging unit (15) and the axial examination unit (16) can be monochromatic or RGB cameras.
[010] The first light source (17) illuminates white light. The first light source (17) is positioned in the vicinity of the radial imaging unit (15) and the axial imaging unit (16). White light is provided to achieve sufficient lightening for capturing image(s) and /or video(s). The second light source (18) illuminates at least one color light and having wavelength ranging from 400 to 500nm. The second light source (18) can be a Bi-color light or can be RGB light (Light emitting diode LED) positioned in vicinity of the radial imaging unit (15) and the axial imaging unit (16). The second light source (18) excites the tissue of vaginal walls and cervix, which indirectly causes fluorescence. The light emanating from the second light source (18) is filtered by a short pass filter (25). The radial imaging unit (15) and/or the axial imaging unit (16) are provided with the long pass filter (26).
[011] The spray unit (22) is detachably connected to the head portion (11) to spray at least one reagent/agent in the vaginal cavity and/or on the cervix. The spray unit (22) contains one or more container that contains one or more reagent/agent. The reagents/agents can be Lugol's Iodine, Acetic Acid or similar other liquids/gels. In one embodiment, at least a portion of the head portion (11) and/or the body portion (12) is layered with a disposable sheath (11c) such that the disposable sheath (11c) can be disposed of after each examination and a new disposable sheath (11c) can be layered for new person undergoing examination. Thus, the disposable sheath (11c) maintains hygiene.
[012] The body portion (12) houses a power source (19), at least one switch (20) and a control panel (21). The power source (19) is in wired connection with the radial imaging unit (15), the axial imaging unit (16), the first light source (17) and the second light source (18). In one embodiment, the power source (19) is a power battery that can be rechargeable or replaceable. In another embodiment, the power source (19) can be direct electric source connected by a plug extending from the housing. In yet another embodiment, the power source (19) can be the power battery of an electronic device such as a mobile phone, a tablet, a desktop computer or similar other electronic devices. The power source (19) can be one or more. The switch (20) is disposed on a surface of the body portion (12). In one embodiment, additionally a control switch (not illustrated in the Figures) can be provided that can control the intensity of emanating light. Further, optionally, a zoom-in and zoom-out switches (23) can be provided which is connected to the radial imaging unit (15), the axial imaging unit (16). Additionally, a switch (24) can be provided to actuate the linear joint (13) and the rotational joint (14). The switches (20, 23, 24) be a slider, a scroll button or a push-button or can be combinations of the slider, the push-button or the scroll button.
[013] The support stand (30) selectively holds the examination device (10). The support stand (30) is also adjustable to move the examination device (10) in vicinity of the person undergoing examination. In one embodiment, the support stand (30) can be positioned on the ground or can be positioned the table. The support stand (30) provides rigid support to the radial imaging unit (15) and the axial imaging unit (16) and hence enables to capture clear images/videos and prevents capturing distorted/blur images/videos which are generally capture when the radial imaging unit (15) and the axial imaging unit (16) are held in hand. Alternatively, if an examiner wishes, the examiner may hold the examination device (10) in the hand.
[014] The device (40) has an input-output controller (40b) connected to an input-output port (40a) which is further connected to an input-output port (27). The device (40) includes a display screen (41), a storage unit (42), an input unit (43) and a processing unit (44). The display screen (41) is in removable connection with the radial imaging unit (15) and the axial imaging unit (16) of the examination device (10) to display at least one image and/or video captured by the radial imaging unit (15) and the axial imaging unit (16). The display screen (41) provides visual display of captured images and videos. The display screen (41) can be of any size as required, i.e. small, medium or large depending on portability requirement. The display screen (41) can be in the room where examination is conducted or can be remotely positioned.
[015] The storage unit (42) stores at least one threshold data and captured at least one image and/or video. The storage unit (42) can be in-built or an external removable device.
[016] The input unit (43) selects desired at least one image and/or video displayed on the display screen (41). The input unit (43) can be a keyboard, a mouse, a stylus, a touch screen/pad or combinations thereof.
[017] The processing unit (44) compares the abnormal and normal areas of entire image instead of just the cavity and hence compares vagina and cervix. The processing unit (44) is in connection with the radial imaging unit (15) and the axial imaging unit (16) and receives images and/or videos therefrom. The processing unit (44) removes impulse noise spikes, specular reflection and blood traces on tissues from the captured image(s) and/or video(s). The processing unit (44) calculates at least one feature for each captured image and/or video. In one embodiment, five key features are calculated for each captured image and/or video which are captured before and after application of the reagent/agent. The five features are RGB intensity values, ratio of each single RGB intensity value, differences in each RGB value, differences in RGB intensity ratios, difference in grey scale intensity values. Image registration for each image and/or video is initiated by assuming a reference center point. Cervix OS is considered as a reference center point. Tissue regions with similar optical properties are grouped together. The groups so formed are intensity values of red, green and blue channels, ratio of intensity of green channel to that in red channel and changes in grey scale intensities. The processing unit (44) has a software application (44a) provided with algorithms such as but not limited to, Generative Learning Model, Logistic Regression, Decision Trees, Random Forest, Neural Network might be used to determine if a region contains neoplastic tissue by comparing abnormal and normal areas for finding regions with neoplastic tissue. Algorithms are programmed using data of regions of high grade squamous intraepithelial lesions in which changes were visually apparent after reagent application. The regions are analyzed for the probability of abnormality using a reference threshold stored in the storage unit (42) and a three dimensional disease probability map is generated and displayed on the display screen (41). The captured images as well as the three dimensional disease probability map can be forwarded to a remote device so that a second opinion or an expert doctor can view the results. Further, the images/videos can have live streaming and be stored at the storage unit (42) for future reference. Hence, a record of patient can be maintained for future reference. The processing unit (40) has an input/output port (40a) removably connected to the input/output port (10a) of the examination device (10). The input/output ports (40a and 10a) can be USB ports, wired plugs such as internet data cables and/or a wireless connections such as Bluetooth, Infrared, Wi-Fi and similar other wireless connections. The device (40) can be a desktop computer, a laptop, a mobile phone or similar other hand-held devices or desktop device that includes a display unit, a controller, a hardware and an input device. The device (40) can have any operating system such as, but not limited to, Android, iOS, Windows, Mac.
[018] The present disclosure also discloses a method for examination of a vaginal cavity and cervix of a human body. The method includes providing the examination device (10) having the head portion (11) and the body portion (12) for medical examination. The body portion (12) examination device (10) is mounted on the support stand (30) and the support stand (30) is adjusted to bring the examination device (10) in vicinity of the person undergoing examination. Alternatively, the examination device (10) can be held in the hand of the examiner. If the examiner requires rotational adjustment, the examiner can selectively manipulates the rotational joint (14) to achieve desired angle of the head portion (11) with respect to the body portion (12) so that the examiner can capture desired image(s) and/or video(s) of the cavity. The examiner can also capture multiple image(s) and/or video(s) from different angular position by manipulating the rotational joint (14). Further, if the examiner requires linear adjustment, the examiner selectively manipulates the linear joint (13) so that the desired length can be achieved. The extended configuration of the examination device (10) helps to insert the head portion (10) deep inside the vaginal cavity for cervix examination. The retracted configuration of the examination device (10) helps the examiner to examine the opening of the vaginal cavity. The head portion (11) is then introduced in the vaginal cavity.
[019] The examiner operates at least one switch (20) to allow flow of current from the power source (19) through a control panel (21) to activate the first light source (17) that emits white light. The examiner can also control the intensity of light by operating the control switch. The examiner then actuates at least one of the radial imaging unit (15), the axial imaging unit (16) to capture image(s) and/or video(s). The captured image(s) and/or video(s) are stored in the storage unit (42). The examiner then activates the second light source (18) and captures image(s) and/or video(s) from the radial imaging unit (15) and/or the axial imaging unit (16). These images are also stored in the storage unit (42). The second light source (18) emanates colored light having wavelength ranging from 400nm to 500nm and the examiner can capture image/video when specific wavelength excites the tissues. The examiner sprays the first reagent/agent, namely, acetic acid, and then again captures images and/or videos in presence of light from the first light source (17) and/or the second light source (18). The examiner sprays the second reagent/agent, namely, Lugol's Iodine, and then again captures images and/or videos in presence of light from the first light source (17) and/or the second light source (18). The captured images are stored in the storage unit (42). Thus, without the need of removal of the examination device (10), the reagents/agents are sprayed through the spray unit (22) and hence cause less discomfort to the person undergoing examination. Although the present disclosure discloses the method in which the examiner captures images/videos with first with white light and then with colored light followed by application of first acetic acid and then Lugol’s Iodine and then captures images/videos, however, the steps mentions are not limited to sequence as described and the examiner may follow any sequence as desired or any other step can be added or deleted as desired to achieve the desired result.
[020] The examiner can view captured images and/or videos on the display screen (41) and can zoom-in and zoom-out for better view through use of the input device (43). Further, the examiner can edit images as desired through the input device (43). The examiner can also share the images and/or videos to the remotely positioned device for expert opinion or for view of another person positioned remotely. The sharing of images and/or videos can be through wired connection or wireless connection.
[021] The examiner can also select images and/or videos for processing in the processing unit (44). The processing unit (44) compares the abnormal and normal areas of entire image instead of just the cavity and hence compares vagina and cervix. The processing unit (44) is in connection with the radial imaging unit (15) and the axial imaging unit (16) and receives images and/or videos therefrom. Alternatively, in event when biopsy images are captured, the processing unit (44) can receive biopsy images. The processing unit (44) removes impulse noise spikes, specular reflection and blood traces on tissues from the captured image(s) and/or video(s). The processing unit (44) calculates at least one feature for each captured image and/or video. In one embodiment, five key features are calculated for each captured image and/or video which are captured before and after application of the reagent/agent. The five features are RGB intensity values, ratio of each single RGB intensity value, differences in each RGB value, differences in RGB intensity ratios, difference in grey scale intensity values. Image registration for each image and/or video is initiated by assuming a reference center point. Cervix OS is considered as a reference center point. Tissue regions with similar optical properties are grouped together. The groups so formed are intensity values of red, green and blue channels, ratio of intensity of green channel to that in red channel and changes in grey scale intensities. Algorithms such as but not limited to, Generative Learning Model, Logistic Regression, Decision Trees, Random Forest, Neural Network might be used to determine if a region contains neoplastic tissue by comparing abnormal and normal areas for finding regions with neoplastic tissue. Algorithms are programmed using data of regions of high grade squamous intraepithelial lesions in which changes were visually apparent after reagent application. The regions are analyzed for the probability of abnormality using a reference threshold stored in the storage unit (42). and a three dimensional disease probability map is generated and displayed on the display screen (41). The captured images as well as the three dimensional disease probability map can be forwarded to a remote device so that a second opinion or an expert doctor can view the results. Further, the images/videos can have live streaming and be stored at the storage unit (42) for future reference. Hence, a record of patient can be maintained for future reference. The processing unit (40) has an input/output port (40a) removably connected to the input/output port (10a) of the examination device (10). The input/output ports (40a and 10a) can be USB ports, wired plugs such as internet data cables and/or a wireless connections such as Bluetooth, Infrared, Wi-Fi and similar other wireless connections. The device (40) can be a desktop computer, a laptop, a mobile phone or similar other hand-held devices or desktop device that includes a display unit, a controller, a hardware and an input device. The device (40) can have any operating system such as, but not limited to, Android, iOS, Windows, Mac.
[021] The system (100) for examination of the vaginal cavity and cervix of the human body has the examination device (10) which is easily inserted in the vaginal cavity without causing discomfort and without the use of speculum. The examination device (10) is also supported by the support stand (30) hence rendering the hand of the examiner free. The support stand (30) also provides capturing clear images and/or videos and hence eliminates the need to recapture images and/or videos and saves time.
[022] The examination device (10) is linearly and rotatably adjustable and hence eases the deep insertion of the head portion (11) in the vaginal cavity which otherwise is not possible and enables capturing images/videos from various angles, typically to completely inspect the cervix and walls of the vaginal cavity. Further, the radial imaging unit (15) and axial imaging unit (16) provides capturing images and videos radially as well as axially. The use of the second light source (18) having wavelength ranging from 400nm to 500nm allows to see abnormalities with the help of auto fluorescence of tissues. Examination can be performed without the need of skilled doctor and then the examination result can be shared with the skilled doctor.
[022] Though the present disclosure describes vaginal cavity and cervix of the human body, however, the present disclosure is not limited for use of human body but can be used for other animals.
[023] The foregoing description conveys the best understanding of the objectives and advantages of the present invention. Different embodiments, steps or alternatives may be made of the inventive concept of this invention. It is to be understood that all matter disclosed herein is to be interpreted merely as illustrative, and not in a limiting sense.
| # | Name | Date |
|---|---|---|
| 1 | 201921027092-STATEMENT OF UNDERTAKING (FORM 3) [05-07-2019(online)].pdf | 2019-07-05 |
| 2 | 201921027092-REQUEST FOR EXAMINATION (FORM-18) [05-07-2019(online)].pdf | 2019-07-05 |
| 3 | 201921027092-POWER OF AUTHORITY [05-07-2019(online)].pdf | 2019-07-05 |
| 4 | 201921027092-FORM-26 [05-07-2019(online)].pdf | 2019-07-05 |
| 5 | 201921027092-FORM FOR STARTUP [05-07-2019(online)].pdf | 2019-07-05 |
| 6 | 201921027092-FORM FOR SMALL ENTITY(FORM-28) [05-07-2019(online)].pdf | 2019-07-05 |
| 7 | 201921027092-FORM 3 [05-07-2019(online)].pdf | 2019-07-05 |
| 8 | 201921027092-FORM 18 [05-07-2019(online)].pdf | 2019-07-05 |
| 9 | 201921027092-FORM 1 [05-07-2019(online)].pdf | 2019-07-05 |
| 10 | 201921027092-FIGURE OF ABSTRACT [05-07-2019(online)].jpg | 2019-07-05 |
| 11 | 201921027092-EVIDENCE FOR REGISTRATION UNDER SSI(FORM-28) [05-07-2019(online)].pdf | 2019-07-05 |
| 12 | 201921027092-DRAWINGS [05-07-2019(online)].pdf | 2019-07-05 |
| 13 | 201921027092-DECLARATION OF INVENTORSHIP (FORM 5) [05-07-2019(online)].pdf | 2019-07-05 |
| 14 | 201921027092-COMPLETE SPECIFICATION [05-07-2019(online)].pdf | 2019-07-05 |
| 15 | 201921027092-CLAIMS UNDER RULE 1 (PROVISIO) OF RULE 20 [05-07-2019(online)].pdf | 2019-07-05 |
| 16 | Abstract1.jpg | 2019-10-12 |
| 17 | 201921027092-ORIGINAL UR 6(1A) FORM 26 & FORM 5-100719.pdf | 2019-12-10 |
| 18 | 201921027092-FORM-9 [22-08-2020(online)].pdf | 2020-08-22 |
| 19 | 201921027092-STARTUP [31-08-2020(online)].pdf | 2020-08-31 |
| 20 | 201921027092-FORM28 [31-08-2020(online)].pdf | 2020-08-31 |
| 21 | 201921027092-FORM 18A [31-08-2020(online)].pdf | 2020-08-31 |
| 22 | 201921027092-FER_SER_REPLY [06-03-2021(online)].pdf | 2021-03-06 |
| 23 | 201921027092-REQUEST FOR ADJOURNMENT OF HEARING UNDER RULE 129A [08-05-2021(online)].pdf | 2021-05-08 |
| 24 | 201921027092-Correspondence to notify the Controller [28-05-2021(online)].pdf | 2021-05-28 |
| 25 | 201921027092-Written submissions and relevant documents [16-06-2021(online)].pdf | 2021-06-16 |
| 26 | 201921027092-PETITION UNDER RULE 137 [11-08-2021(online)].pdf | 2021-08-11 |
| 27 | 201921027092-PatentCertificate12-08-2021.pdf | 2021-08-12 |
| 28 | 201921027092-IntimationOfGrant12-08-2021.pdf | 2021-08-12 |
| 29 | 201921027092-US(14)-HearingNotice-(HearingDate-11-05-2021).pdf | 2021-10-19 |
| 30 | 201921027092-US(14)-ExtendedHearingNotice-(HearingDate-04-06-2021).pdf | 2021-10-19 |
| 31 | 201921027092-ORIGINAL UR 6(1A) FORM 1-220621.pdf | 2021-10-19 |
| 32 | 201921027092-FER.pdf | 2021-10-19 |
| 33 | 201921027092-RELEVANT DOCUMENTS [08-04-2022(online)].pdf | 2022-04-08 |
| 34 | 201921027092-FORM-27 [04-07-2024(online)].pdf | 2024-07-04 |
| 35 | 201921027092-FORM-27 [08-05-2025(online)].pdf | 2025-05-08 |
| 1 | Searchstrategy201921027092E_01-09-2020.pdf |