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WO2010131169A1 - Cervicovaginal examination device - Google Patents

Cervicovaginal examination device Download PDF

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Publication number
WO2010131169A1
WO2010131169A1 PCT/IB2010/052011 IB2010052011W WO2010131169A1 WO 2010131169 A1 WO2010131169 A1 WO 2010131169A1 IB 2010052011 W IB2010052011 W IB 2010052011W WO 2010131169 A1 WO2010131169 A1 WO 2010131169A1
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WO
WIPO (PCT)
Prior art keywords
unit
cervix
cervicovaginal
transformation zone
images
Prior art date
Application number
PCT/IB2010/052011
Other languages
French (fr)
Inventor
Sanjay Jayavanth
Sarif Kumar Naik
Payal Keswarpu
Celine Firtion
Original Assignee
Koninklijke Philips Electronics N.V.
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Koninklijke Philips Electronics N.V. filed Critical Koninklijke Philips Electronics N.V.
Publication of WO2010131169A1 publication Critical patent/WO2010131169A1/en

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B34/00—Computer-aided surgery; Manipulators or robots specially adapted for use in surgery
    • A61B34/20—Surgical navigation systems; Devices for tracking or guiding surgical instruments, e.g. for frameless stereotaxis
    • G—PHYSICS
    • G06—COMPUTING; CALCULATING OR COUNTING
    • G06T—IMAGE DATA PROCESSING OR GENERATION, IN GENERAL
    • G06T7/00—Image analysis
    • G06T7/70—Determining position or orientation of objects or cameras
    • G06T7/73—Determining position or orientation of objects or cameras using feature-based methods
    • G06T7/75—Determining position or orientation of objects or cameras using feature-based methods involving models
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B10/00—Instruments for taking body samples for diagnostic purposes; Other methods or instruments for diagnosis, e.g. for vaccination diagnosis, sex determination or ovulation-period determination; Throat striking implements
    • A61B10/02—Instruments for taking cell samples or for biopsy
    • A61B10/0291—Instruments for taking cell samples or for biopsy for uterus
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/42—Gynaecological or obstetrical instruments or methods
    • A61B2017/4216—Operations on uterus, e.g. endometrium
    • A61B2017/4225—Cervix uteri
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B34/00—Computer-aided surgery; Manipulators or robots specially adapted for use in surgery
    • A61B34/20—Surgical navigation systems; Devices for tracking or guiding surgical instruments, e.g. for frameless stereotaxis
    • A61B2034/2046—Tracking techniques
    • A61B2034/2065—Tracking using image or pattern recognition
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B34/00—Computer-aided surgery; Manipulators or robots specially adapted for use in surgery
    • A61B34/25—User interfaces for surgical systems
    • A61B2034/256—User interfaces for surgical systems having a database of accessory information, e.g. including context sensitive help or scientific articles
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/36—Image-producing devices or illumination devices not otherwise provided for
    • A61B2090/364—Correlation of different images or relation of image positions in respect to the body
    • A61B2090/365—Correlation of different images or relation of image positions in respect to the body augmented reality, i.e. correlating a live optical image with another image
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/36—Image-producing devices or illumination devices not otherwise provided for
    • A61B90/361—Image-producing devices, e.g. surgical cameras
    • G—PHYSICS
    • G06—COMPUTING; CALCULATING OR COUNTING
    • G06T—IMAGE DATA PROCESSING OR GENERATION, IN GENERAL
    • G06T2207/00—Indexing scheme for image analysis or image enhancement
    • G06T2207/10—Image acquisition modality
    • G06T2207/10068—Endoscopic image
    • G—PHYSICS
    • G06—COMPUTING; CALCULATING OR COUNTING
    • G06T—IMAGE DATA PROCESSING OR GENERATION, IN GENERAL
    • G06T2207/00—Indexing scheme for image analysis or image enhancement
    • G06T2207/30—Subject of image; Context of image processing
    • G06T2207/30004—Biomedical image processing

Definitions

  • the present subject matter relates to the field of medical devices and more specifically to the field of medical devices used to conduct cervicovaginal examination.
  • US2004/0220478 discloses a method for imaging an endometrial cavity.
  • the method comprises a) positioning an endoscope at least partially within the endometrial cavity b) imaging tissue within the endometrial cavity around a circumference of at least a portion of the endoscope c) determining an area of interest and d) performing a biopsy of tissue from the determined area of interest.
  • the disclosed method may lead to a) collection of samples from inappropriate areas of interest b) incorrect collection of samples c) inadequate collection of samples d) imprecise collection of samples. This may result in inaccurate diagnosis.
  • a cervicovaginal examination device comprising: a front assembly unit for housing an imaging module for obtaining images of a cervicovaginal canal of a subject; a navigational guidance unit for generating navigational signals, based on an analysis of the obtained images, for navigating the front assembly unit towards a cervical opening region; an identification unit for identifying a transformation zone, based on an analysis of the obtained images, the transformation zone being the junction between the ecto- cervix and the endo-cervix; and a sample collecting unit for collecting cytological samples from the identified transformation zone.
  • cervical cancer screening procedure involves detection of cytological precursors of cancer in the Pap smear samples or detection of Human Papilloma Virus (HPV). This is based on the fact that certain strains of HPV are responsible for cervical carcinoma. The detection of cytological precursors of cancer in the Pap smear samples or detection of HPV requires collection of cervical cytological samples.
  • HPV Human Papilloma Virus
  • cervical cytological samples could be difficult due to: a) variation in orientation of the uterus i.e. anteversion and retroversion, which affects the position of the external orifice (os) of cervix b) variation in the lengths of the cervixes in pregnant and non-pregnant women c) difficulty in finding the opening of the cervix d) difficulty in identification of the transformation zone due to its dynamic nature e) non-cooperation of the woman due to discomfort or painful procedure
  • optimal cervical specimen includes sampling of the squamous and columnar epithelium in the transformation zone.
  • the inventors have recognized that the transformation zone of the cervix has to be sampled for effective and appropriate cervical cancer screening procedure like Pap smear/HPV testing.
  • the present subject matter discloses a device that can aid in collecting samples from the transformation zone.
  • the disclosed device can be made automatic.
  • the word automatic here refers to operating the disclosed device with minimal human intervention.
  • the disclosed device can automatically examine the cervicovaginal canal of a subject and collect the samples from the transformation zone.
  • the front assembly unit On inserting the front assembly unit inside the cervicovaginal canal of the subject, the front assembly unit could obtain images of the cervicovaginal canal.
  • the navigation unit could generate navigational signals based on an analysis of the obtained images.
  • the navigation signals could aid in the navigation of the front assembly unit towards a cervical opening region.
  • the obtained images could be analyzed to identify the transformation zone.
  • the sample collecting unit can be initiated to collect the samples from the identified transformation zone.
  • the cervicovaginal examination process can be automated and the samples could be obtained from the transformation zone, which is the most appropriate site for cervical cancer screening.
  • the disclosed device can be designed for manual operation.
  • the disclosed device can provide navigational guidance to the user to navigate the front assembly unit through the cervicovaginal canal and locate the cervix. On reaching the cervix, a 360° view of the cervix can be displayed to the user. This allows the user to view the cervix and examine the cervix. Further, the disclosed device can provide guidance to the user to obtain images substantially around the cervical opening region. The images of the cervical opening region can be suitably analyzed to identify the transformation zone.
  • the disclosed device can provide navigational guidance to the user to view the identified transformation zone.
  • the disclosed device can further provide guidance to the user to examine the identified transformation zone by suitably pointing to the identified transformation zone.
  • the disclosed device can provide navigational guidance to the user to collect samples precisely from the identified transformation zone.
  • the disclosed device can thus result in correct, adequate and precise collection of samples from the transformation zone, which is the most appropriate site for collecting samples for cervical cancer screening.
  • the disclosed device can improve the accuracy of diagnosis of cervical cancer.
  • the disclosed device can i. assist the user in navigating the front assembly unit and locating the cervix ii. provide a plurality of images of the cervicovaginal canal and allow better visualization of the cervicovaginal canal iii. allow better visualization of the cervix iv. obtain 360° view of the cervix v. guide the user in obtaining images substantially around the cervical opening region vi. guide the user in identifying the transformation zone vii. guide the user in collecting samples from the identified transformation zone viii. reduce pain and discomfort to the woman ix. reduce the chances of injury to neighboring organs (e.g.
  • the disclosed device provides guidance to the user a) to identify the transformation zone and b) to collect samples precisely from the identified transformation zone by pointing at the identified transformation zone and enables safe withdrawal of the samples without any loss of samples.
  • the probability of collecting incorrect samples/inadequate samples is reduced since the disclosed device provides guidance to the user to collect samples precisely from the transformation zone. Hence, the collected samples from the transformation zone can improve the accuracy of cervical cancer screening.
  • the navigational guidance unit comprises a location sensor for sensing a location of the front assembly unit inside the cervicovaginal canal of the subject; a labelling unit for labeling each obtained image with the sensed location from which the image is obtained; and a matching unit for matching a obtained image with an image from an image database and generating the navigational signals.
  • This embodiment is advantageous in sensing the location of the front assembly unit in the cervicovaginal canal and associating the obtained image with the sensed location.
  • the navigational signals are generated by matching the obtained image with an image from the image database.
  • the navigational guidance can be suitably adapted and all possible eligible views of the cervicovaginal canal can be displayed to the user. This can help the user in examining the cervicovaginal canal.
  • Cervix is the lowest part of the uterus and opens into the vagina.
  • the cervix generally measures around 2.5 - 3.0 cm in diameter and 3.0 - 5.0 cm in length.
  • the direction of the cervix depends on whether the uterus is anteverted (anteriorly inclined) or retroverted (posteriorly inclined).
  • the normal anatomic position of the cervix is angulated slightly downward and backward.
  • the cervical canal is approximately 8 mm in width.
  • Matching could involve a) checking for variations in the 2-d profile of the cervix b) checking whether the uterus is in anteversion and retroversion position.
  • the available anatomical information about the cervix and the matching of the obtained images with the image from the image database can help the user in locating the cervix without much difficulty.
  • the image database comprises a plurality of images of the cervicovaginal canal for each of a plurality of subjects, each image being classified based on the subject's age and parity.
  • the word parity here refers to the number of live born children a woman has delivered.
  • the image database can act as a baseline. It can help in analyzing the obtained images by comparing it with images in the database. Further, the image database can be periodically updated and aid in improving the diagnosis of cervical cancer.
  • the plurality of images are cross-referenced with one or more of anatomical description of the cervicovaginal canal geometrical measurements of the uterine cavity geometrical measurements of the cervicovaginal canal orientation of the uterus
  • This embodiment can help the user i) to check for variations in the 2-d profile of the cervix ii) to check whether the uterus is in anterversion and retroversion position.
  • the cross-referenced images could help the user in examining the cervicovaginal canal and locating the cervix without much difficulty.
  • the navigational guidance unit further comprises a segmentation unit for segmenting the obtained images; a recognition unit for recognizing a target pattern in the segmented images, the target pattern being a pattern of two substantially concentric circular objects of the image; and a cervix locator for locating the cervix based on the recognized target pattern.
  • This embodiment is advantageous in providing continuous navigational guidance to the user in navigating the front assembly unit and locating the external orifice (os) region.
  • the cervix is generally divided into ecto-cervix and endo-cervix. The ecto- cervix is closer to the vagina and is generally 3 cm long and 2.5 cm wide.
  • the ecto-cervix has a convex, elliptical surface has the external orifice (os) of the cervix which opens into the vagina.
  • the external orifice (os) is bounded by two lips, an anterior and a posterior, of which the anterior is the shorter and thicker, although on account of the slope of the cervix, it projects lower than the posterior.
  • the size and shape of the external orifice (os) and the ecto- cervix varies widely with age, hormonal state and whether the woman has previously given birth through vaginal canal or cesarian section.
  • This embodiment provides navigational guidance to the user to locate the external orifice (os) and the cervical canal region by making use of image processing techniques and available anatomical information about cervix.
  • image processing techniques e.g., a normal cervical image and a cancerous cervical image are different and hence the pixel properties are different.
  • Color and texture features could be used to segment the obtained images. Segmentation could result in two different segments namely i. one for external orifice (small segment in the center) and ii. the other for the tissue around the cervix making another region and encircling the external orifice.
  • the boundary of these two regions could represent two circle-like objects one inside the other.
  • a pattern matching algorithm could determine the number of circle-like objects found in the images and their relative position.
  • the relative position i.e. one inside the other could indicate the presence of the desired location of the cervix.
  • the navigational guidance can: i. indicate to the user the direction to be followed for inserting the front assembly unit ii. make use of appropriate sounds to guide/warn the user while the front assembly unit is being maneuvered iii. display the image overlaid with navigational information (e.g. the navigational information could be generated by measurements and analysis of the obtained images) iv.
  • the volume of the sound can be suitably increased/decreased (within acceptable limits) v. discourage the user from moving the front assembly unit away from the line of sight of the cervix vi. provide continuous guidance to the user to keep the front assembly unit always in line with the cervix and move it forward to reach the cervix vii. provide navigational indications using directional arrows
  • the identification unit comprises an image analysis unit for analyzing the obtained images for a change in at least one of color, texture or cell shape. This embodiment is advantageous in identifying the transformation zone which could be the most appropriate site for cervical sample collection.
  • the ecto-cervix appears bulkier and the external orifice (os) is referred to as the endo- cervix. It varies widely in length and width, along with the cervix overall.
  • the endo cervical canal measures 7 - 8 mm at its widest in woman of reproductive age.
  • the junction between the ecto-cervix and the endo- cervix is known as the transformation zone due to change in lining cells from squamous type to columnar type. Cervical cancer most commonly arises from the transformation zone of the cervix.
  • the disclosed device could be directed towards the cervical opening (os) to obtain images of the external orifice (os) region and the cervical canal to identify the transformation zone i.e. the junction between the ecto-cervix and the endo-cervix.
  • the obtained images could be analyzed for several features like morphology, color (mean color value of the pixels, histogram in HSV and RGB color space), texture (measure of roughness, statistics from co-occurrence matrix, wavelet coefficients) for identification of the junction.
  • the ecto- cervix is known to be smooth, rich pink in color; while the endo-cervix is not so smooth due to the presence of papillary cluster with interspaced clefts and orange to red in color.
  • the obtained images could be analyzed for change in color (pink to orange/red) or change in texture (smooth to rough).
  • the ecto-cervix has flat squamous cells and the endo-cervix has tall columnar cells.
  • the transformation zone could be identified based on such pre-determined characteristic variations. Further, the change in cell shape in the transformation zone could be identified (irregular, flat shape to defined columnar shape).
  • a small magnification factor e.g. 4x to 1Ox
  • the navigational guidance can provide the user i. information associated with the depth of insertion and prevent over insertion; suitable navigational information can be displayed based on whether the pattern of two concentric circle like objects is present or absent; if the depth of insertion is between 4.0 - 5.0 cms [ ⁇ min(length of the vaginal canal)], then the user could be prompted to insert the front assembly unit in small incremental distances; If the maximum depth i.e. 10.0 cm is reached and the cervix is not identified, then a "cervix location failed/Retry" message could be displayed. Further, sounds could be used to warn the user during the entire navigation process ii.
  • the sample collecting unit comprises a sample collector containing a spatula/brush enclosed in a capsule; and a sample collection guidance unit for providing navigational guidance to maneuver the spatula/brush towards the identified transformation zone for collecting the cytological samples from the identified transformation zone.
  • the user can activate the sample collector and deploy the sample collector to collect the samples.
  • the identified transformation zone can be marked by drawing boundaries. The image can be displayed with an arrow pointing at the identified transformation zone. This could aid the user to deploy the spatula/brush to the transformation zone and collect the samples precisely from the transformation zone.
  • the disclosed sample collecting unit can improve cervical sample collection. Further, the sample collector could be designed to enclose the spatula/brush in a capsule. This could allow the user to enable safe, lossless collection of the samples from the transformation zone. This could result in collection of correct and adequate samples. This could improve the accuracy of diagnosis of cervical cancer screening.
  • the sample collecting unit further comprises a reservoir unit for storing a fluid; and a control unit associated with the reservoir unit for spraying the fluid on the identified transformation zone.
  • This embodiment provides further navigation guidance to the user and enables better visualization of the identified transformation zone and the abnormal areas if any. This can further improve the collection of the samples from the identified transformation zone and result in correct and adequate sample collection. This can further improve the accuracy of diagnosis.
  • the identification unit further comprises an overlay unit for overlaying the boundaries of the identified transformation zone on the obtained images thereby enabling display of the overlaid images. This could aid the user to precisely identify the transformation zone. This can result in collection of samples precisely from the identified transformation zone and improve the diagnosis of cervical cancer.
  • the further object of the present subject matter is realized by providing a cervicovaginal examination method comprising inserting a front assembly unit of a cervicovaginal examination device into cervicovaginal canal of a subject and obtaining images of the cervicovaginal canal of the subject; generating navigational signals, based on an analysis of the obtained images, for navigating the front assembly unit towards a cervical opening region; identifying a transformation zone, based on an analysis of the obtained images, the transformation zone being the junction between the ecto-cervix and the endo-cervix; and collecting cytological samples from the identified transformation zone.
  • FIG. 1 schematically shows an exemplary procedure for Pap smear sample collection
  • Fig. 2 shows an exemplary schematic block diagram of a device for performing cervicovaginal examination according to an embodiment of the present subject matter
  • Fig. 3 shows an exemplary schematic block diagram of a navigational guidance unit according to an embodiment of the present subject matter
  • Fig. 4 shows variation in the 2-d profile of an exemplary cervix when the uterus is in normal, anteversion and retroversion position (left to right);
  • Fig. 5 shows an exemplary schematic block diagram of the navigational guidance unit according to a still further embodiment of the present subject matter
  • Fig. 6 schematically shows the boundary around the external orifice (os) and the cervix
  • Fig. 7 schematically shows exemplary schematic block diagram of an identification unit according to an embodiment of the present subject matter
  • Fig. 8 schematically shows exemplary frontal and sagittal view of an exemplary cervix and vagina
  • Fig. 9 shows an exemplary schematic block diagram of a sample collecting unit according to an embodiment of the present subject matter
  • Fig. 10 shows an exemplary schematic block diagram of the sample collecting unit according to a still further embodiment of the present subject matter
  • Fig. 11 schematically shows an exemplary flow chart illustrating the method of performing cervicovaginal examination according to an embodiment of the present subject matter.
  • cervical cytology sample collection procedure generally involves knowledge of the anatomical location of the cervix accompanied by manual visualization of the cervix. This is followed by scraping the cellular material from the uterine cervix. A piece of cotton or a brush or a small wooden stick is used to gently scrape the cervix. The material collected is then smeared on a slide or collected in a specific liquid phase for concentration and subsequent specific tests. In the cyto pathology laboratory the collected cells are stained. The stained cells are observed under a microscope to find out if they are abnormal.
  • the smear is classified according to recommendations by the Bethesda system of classification of cervical smear abnormality.
  • Human Papilloma Virus (HPV) detection can be done on the same sample if the cervical cells have been put in the liquid phase otherwise HPV testing may require a separate sampling at the same site.
  • HPV Human Papilloma Virus
  • the present method of cervical cytological sample may be difficult due to: a) variation in orientation of the uterus i.e. anteversion and retroversion, which affects the position of the external orifice (os) of cervix b) variation in the length of the cervixes in pregnant and non-pregnant women c) difficulty in finding the opening of the cervix d) difficulty in identification of the transformation zone due to its dynamic nature e) non-cooperation of the woman due to discomfort or painful procedure
  • the collection of the cervical cytological samples even by an experienced user e.g. gynecologist
  • optimal cervical specimen includes sampling of the squamous and columnar epithelium in the transformation zone.
  • the inventors have recognized that the transformation zone of the cervix has to be sampled for effective and appropriate cervical cancer screening procedure like Pap smear/HPV testing.
  • the device 200 can aid a user in collecting the cytological samples from the transformation zone.
  • the disclosed device 200 includes
  • a front assembly unit 210 housing an imaging module 212
  • the front assembly unit 210 is optimally shaped to match the cervicovaginal canal of a subject.
  • the front assembly unit 210 houses an imaging module 212.
  • the imaging module may include miniaturized camera. The camera can be configured to obtain images of the cervicovaginal canal.
  • the navigational guidance unit 230 could generate navigational signals, based on an analysis of the obtained images, for navigating the front assembly unit towards a cervical opening region.
  • the identification unit 240 can be configured to identify a transformation zone, based on an analysis of the obtained images, the transformation zone being the junction between ecto-cervix and endo-cervix.
  • the sample collecting unit 250 can be configured to collect the cytological samples from the identified transformation zone.
  • the disclosed device 200 can provide navigational guidance to the user to navigate the front assembly unit 210 through the cervicovaginal canal of the subject and locate the cervix. On reaching the cervix, a 360° view of the cervix can be displayed to the user. This allows the user to view the cervix and examine the cervix. Further, the disclosed device 200 can provide guidance to the user to obtain images substantially around the cervical opening region. Furthermore, the disclosed device 200 can suitably analyze the images of the cervical opening region and identify the transformation zone.
  • the disclosed device 200 can provide navigational guidance to the user to view the identified transformation zone.
  • the disclosed device 200 can further provide guidance to the user to examine the identified transformation zone by suitably pointing to the identified transformation zone.
  • the disclosed device 200 can provide navigational guidance to the user to collect samples precisely from the identified transformation zone.
  • the disclosed device 200 can thus result in correct, adequate and precise collection of samples from the transformation zone, which is the most appropriate site for collecting samples for cervical cancer screening.
  • the disclosed device 200 can improve the accuracy of diagnosis of cervical cancer.
  • the disclosed medical device 200 can i. assist the user in navigating the front assembly unit and locating the cervix ii. provide a plurality of images of the cervicovaginal canal and allow better visualization of the cervicovaginal canal iii. allow better visualization of the cervix iv. obtain 360° view of the cervix v. guide the user in obtaining images substantially around the cervical opening region vi. guide the user in identifying the transformation zone vii. guide the user in collecting samples from the identified transformation zone viii. reduce pain and discomfort to the woman ix. reduce the chances of injury to neighboring organs (e.g.
  • the disclosed device 200 can provide guidance to the user a) to identify the transformation zone and b) to collect samples precisely from the identified transformation zone by pointing at the identified transformation zone and enabling safe withdrawal of the samples without any loss of samples.
  • the probability of collecting incorrect samples/inadequate samples is reduced since the disclosed device provides guidance to the user to collect samples precisely from the transformation zone. Hence, the collected samples from the transformation zone can improve the accuracy of cervical cancer screening.
  • the navigational guidance unit 230 comprises i. a location sensor 232 ii. a labeling unit 233 iii. a matching unit 234
  • the location sensor 232 can be configured to sense a location of the front assembly unit inside the cervicovaginal canal of the subject.
  • the labeling unit 233 can be configured to label each obtained image with the sensed location from which the image is obtained.
  • the matching unit 234 can be configured to match a obtained image with an image from an image database and generate the navigational signals.
  • This embodiment is advantageous in sensing the location of the front assembly unit in the cervicovaginal canal and associating the obtained image with the sensed location.
  • the navigational signals are generated by matching the obtained image with an image from the image database.
  • the navigational guidance can be suitably adapted and all possible eligible views of the cervicovaginal canal can be displayed to the user. This can help the user in examining the cervicovaginal canal.
  • Cervix is the lowest part of the uterus and opens into the vagina.
  • the cervix generally measures around 2.5 - 3.0 cm in diameter and 3.0 - 5.0 cm in length.
  • the direction of the cervix depends on whether the uterus is anteverted (anteriorly inclined) or retroverted (posteriorly inclined).
  • the normal anatomic position of the cervix is angulated slightly downward and backward.
  • the cervical canal is approximately 8 mm in width. Matching could involve i) checking for variations in the 2-d profile of the cervix as shown in Fig. 4 ii) checking whether the uterus is in anteversion and retroversion position.
  • Fig. 4a shows the cervicovaginal canal in central position
  • the available anatomical information about the cervix and matching the obtained images with the image from the image database can help the user in locating the cervix without much difficulty.
  • the image database could include a plurality of images of the cervicovaginal canal for each of a plurality of subjects, each image being classified based on the subject's age and parity.
  • the word parity here refers to the number of live born children a woman has delivered.
  • the image database can act as a baseline. It can help in analyzing the obtained images by comparing it with images in the database. Further, the image database can be periodically updated. The image database can aid in improving the diagnosis of cervical cancer.
  • the plurality of images could be cross-referenced with one or more of anatomical description of the cervicovaginal canal geometrical measurements of the uterine cavity geometrical measurements of the cervicovaginal canal orientation of the uterus
  • the cross-referenced images could help the user in examining the cervicovaginal canal and locating the cervix without much difficulty.
  • the navigational guidance unit 230 further includes i. a segmentation unit 342 ii. a recognition unit 346 iii. a cervix locator 348
  • This embodiment is advantageous in providing continuous navigational guidance to the user in navigating the front assembly unit and locating the external orifice (os) and the cervical canal region.
  • the cervix is generally divided into ecto-cervix and endo- cervix.
  • the ecto-cervix is closer to the vagina and is generally 3 cm long and 2.5 cm wide.
  • the ecto-cervix has a convex, elliptical surface has the external orifice (os) of the cervix which opens into the vagina.
  • the external orifice (os) is bounded by two lips, an anterior and a posterior, of which the anterior is the shorter and thicker, although on account of the slope of the cervix, it projects lower than the posterior.
  • the size and shape of the external orifice (os) and the ecto-cervix varies widely with age, hormonal state and whether the woman has previously given birth through vaginal canal or cesarian section.
  • This embodiment provides navigational guidance to the user to locate the external orifice (os) and the cervical canal region by making use of image processing techniques and available anatomical information about cervix.
  • a normal cervical image and a cancerous cervical image are different and hence the pixel properties are different.
  • Color and texture features could be used to segment the obtained images. Segmentation could result in two different segments as shown in Fig. 6, namely
  • the boundary of these two regions could represent two circle-like objects one inside the other.
  • a pattern matching algorithm could determine the number of circle-like objects found in the images and their relative position.
  • the relative position i.e. one inside the other could indicate the presence of the desired location of the cervix.
  • the navigational guidance can:
  • navigational information e.g. the navigational information could be generated by measurements and analysis of the obtained images
  • the volume of the sound can be suitably increased/decreased (within acceptable limits)
  • V. discourage the user from moving the front assembly unit away from the line of sight of the cervix
  • VI. provide continuous guidance to the user to keep the front assembly unit always in line with the cervix and move it forward to reach the cervix, its opening and the cervical canal
  • the identification unit 240 includes an image analysis unit for analyzing the obtained images for a change in at least one of color, texture or cell shape.
  • This embodiment is advantageous in identifying the transformation zone which could be the most appropriate site for cervical sample collection.
  • the ecto-cervix appears bulkier and the external orifice (os) is referred to as the endo-cervix. It varies widely in length and width, along with the cervix overall.
  • the endo cervical canal measures 7 - 8 mm at its widest in woman of reproductive age.
  • the junction between the ecto-cervix and the endo- cervix is known as the transformation zone due to change in lining cells from squamous type to columnar type. Cervical cancer most commonly arises from the transformation zone of the cervix.
  • the disclosed device could be directed towards the cervical opening (os) and to obtain images of the external orifice (os) and the cervical canal region to identify the transformation zone i.e. the junction between the ecto- cervix and the endo-cervix.
  • the obtained images could be analyzed for several features like morphology, color (mean color value of the pixels, histogram in HSV and RGB color space), texture (measure of roughness, statistics from co-occurrence matrix, wavelet coefficients) for identification of the junction.
  • the obtained images could be analyzed for change in color (pink to orange/red) or change in texture (smooth to rough).
  • the ecto- cervix is known to be smooth, rich pink in color; while the endo-cervix is not so smooth due to the presence of papillary cluster with interspaced clefts and orange to red in color.
  • the ecto-cervix has flat squamous cells and the endo-cervix has tall columnar cells. The transformation zone could be identified based on such pre-determined characteristic variations.
  • the change in cell shape in the transformation zone could be identified (irregular, flat shape to defined columnar shape).
  • a small magnification factor e.g. 4x to 1Ox
  • 4x to 1Ox could be used to facilitate the identification of the cell shapes.
  • the identification unit 240 further includes an overlay unit 244.
  • the overlay unit can overlay the boundaries of the identified transformation zone on the obtained images thereby enabling display of the overlaid images.
  • the navigational guidance can provide the user i. information associated with the depth of insertion and prevent over insertion; suitable navigational information can be displayed based on whether the pattern of two concentric circle like objects is present or absent; if the depth of insertion is between 4.0 - 5.0 cms [ ⁇ min(length of the vaginal canal), refer to Fig. 8], then the user could be prompted to insert the front assembly unit in small incremental distances; If the maximum depth i.e. 10.0 cm is reached (refer to Fig.
  • cervix location failed/Retry a "cervix location failed/Retry" message could be displayed. Further, sounds could be used to warn the user during the entire navigation process ii. guidance to insert the front assembly unit at the tip of the external orifice (os) and the cervical canal for identifying the transformation zone iii. an arrow pointing at the identified transformation zone to help the user in examining the transformation zone
  • the sample collecting unit 250 includes i. a sample collector 254 containing a spatula/brush enclosed in a capsule ii. a sample collection guidance unit 256 for providing navigational guidance to maneuver the spatula/brush towards the identified transformation zone for collecting the cytological samples from the identified transformation zone.
  • the user can activate the sample collector and deploy the sample collector to collect the samples. Further, the identified transformation zone can be marked by drawing boundaries. The image can be displayed with an arrow pointing at the identified transformation zone. This could aid the user to deploy the spatula/brush to the transformation zone and collect the samples precisely from the transformation zone.
  • the disclosed sample collecting unit 250 can improve cervical sample collection. Further, the sample collector could be designed to enclose the spatula/brush in a capsule. This could allow the user to enable safe, lossless collection of the samples from the transformation zone. This could result in collection of correct and adequate samples. This could improve the accuracy of diagnosis of cervical cancer screening.
  • the sample collecting unit 250 further includes i. a reservoir unit 260 for storing a fluid (e.g. acetone) and ii. a control unit 262 associated with the reservoir unit 260 for spraying the fluid on the identified transformation zone
  • a fluid e.g. acetone
  • This embodiment provides further navigation guidance to the user and enables better visualization of the identified transformation zone. This can further improve the collection of the samples from the identified transformation zone and result in correct and adequate sample collection. This can further improve the accuracy of diagnosis.
  • the method 1100 for performing cervicovaginal examination includes the following steps: I. Step 1102 of inserting a front assembly unit of a cervicovaginal device into cervicovaginal canal of a subject and obtaining images of the cervicovaginal canal of the subject
  • the present subject matter discloses a device that can provide guidance to the user a) to identify the transformation zone and b) to precisely collect samples from the identified transformation zone by pointing at the identified transformation zone and enables safe withdrawal of the samples without any loss of samples.
  • the probability of collecting incorrect samples/inadequate samples is reduced since the disclosed medical device provides guidance to the user to precisely collect samples from the transformation zone.
  • the collected samples from the transformation zone can improve the accuracy of cervical cancer screening.
  • a cervicovaginal examination device comprises a front assembly unit for housing an imaging module for obtaining images of a cervicovaginal canal of a subject; a navigational guidance unit for generating navigational signals, based on an analysis of the obtained images, for navigating the front assembly unit towards a cervical opening region; an identification unit for identifying a transformation zone, based on an analysis of the obtained images, the transformation zone being the junction between the ecto- cervix and the endo-cervix; and a sample collecting unit for collecting cytological samples from the identified transformation zone.

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Abstract

A cervicovaginal examination device (200) is disclosed. The device comprises a front assembly unit (210) for housing an imaging module (212) for obtaining images of a cervicovaginal canal of a subject, a navigational guidance unit (230) for generating navigational signals, based on an analysis of the obtained images, for navigating the front assembly unit towards a cervical opening region, an identification unit (240) for identifying a transformation zone, based on an analysis of the obtained images, the transformation zone being the junction between the ecto-cervix and the endo-cervix and a sample collecting unit (250) for collecting cytological samples from the identified transformation zone. The disclosed device can aid in collecting cytological samples from the identified transformation zone which is the most appropriate site for collecting cytological samples for cervical cancer screening and hence can improve cervical cancer diagnosis.

Description

Cervicovaginal Examination Device
FIELD OF THE INVENTION
The present subject matter relates to the field of medical devices and more specifically to the field of medical devices used to conduct cervicovaginal examination.
BACKGROUND OF THE INVENTION
US2004/0220478 discloses a method for imaging an endometrial cavity. The method comprises a) positioning an endoscope at least partially within the endometrial cavity b) imaging tissue within the endometrial cavity around a circumference of at least a portion of the endoscope c) determining an area of interest and d) performing a biopsy of tissue from the determined area of interest. The disclosed method may lead to a) collection of samples from inappropriate areas of interest b) incorrect collection of samples c) inadequate collection of samples d) imprecise collection of samples. This may result in inaccurate diagnosis.
SUMMARY OF THE INVENTION Accordingly it is an object of the present subject matter to provide a device for performing cervicovaginal examination that can improve the collection of samples and accuracy of the diagnosis. It is a further object of the present subject matter to provide a cervicovaginal examination method that can improve the collection of the samples and accuracy of the diagnosis. The present subject matter is defined by the independent claims. The dependent claims define advantageous embodiments.
The object of the present subject matter is realized by providing a cervicovaginal examination device comprising: a front assembly unit for housing an imaging module for obtaining images of a cervicovaginal canal of a subject; a navigational guidance unit for generating navigational signals, based on an analysis of the obtained images, for navigating the front assembly unit towards a cervical opening region; an identification unit for identifying a transformation zone, based on an analysis of the obtained images, the transformation zone being the junction between the ecto- cervix and the endo-cervix; and a sample collecting unit for collecting cytological samples from the identified transformation zone.
Generally cervical cancer screening procedure involves detection of cytological precursors of cancer in the Pap smear samples or detection of Human Papilloma Virus (HPV). This is based on the fact that certain strains of HPV are responsible for cervical carcinoma. The detection of cytological precursors of cancer in the Pap smear samples or detection of HPV requires collection of cervical cytological samples.
The collection of cervical cytological samples could be difficult due to: a) variation in orientation of the uterus i.e. anteversion and retroversion, which affects the position of the external orifice (os) of cervix b) variation in the lengths of the cervixes in pregnant and non-pregnant women c) difficulty in finding the opening of the cervix d) difficulty in identification of the transformation zone due to its dynamic nature e) non-cooperation of the woman due to discomfort or painful procedure The collection of cervical cytological samples even by an experienced user
(e.g. gynecologist) could lead to a) incorrect collection of samples from inappropriate regions b) inadequate collection of samples c) imprecise collection of samples. This could result in inaccurate diagnosis.
The inventors have recognized that most of the cervical cancers originate in the transformation zone. Hence, optimal cervical specimen includes sampling of the squamous and columnar epithelium in the transformation zone. The inventors have recognized that the transformation zone of the cervix has to be sampled for effective and appropriate cervical cancer screening procedure like Pap smear/HPV testing.
The present subject matter discloses a device that can aid in collecting samples from the transformation zone. The disclosed device can be made automatic. The word automatic here refers to operating the disclosed device with minimal human intervention. The disclosed device can automatically examine the cervicovaginal canal of a subject and collect the samples from the transformation zone. On inserting the front assembly unit inside the cervicovaginal canal of the subject, the front assembly unit could obtain images of the cervicovaginal canal. The navigation unit could generate navigational signals based on an analysis of the obtained images. The navigation signals could aid in the navigation of the front assembly unit towards a cervical opening region. The obtained images could be analyzed to identify the transformation zone. On identifying the transformation zone, the sample collecting unit can be initiated to collect the samples from the identified transformation zone. Hence, the cervicovaginal examination process can be automated and the samples could be obtained from the transformation zone, which is the most appropriate site for cervical cancer screening.
In some embodiments, the disclosed device can be designed for manual operation. The disclosed device can provide navigational guidance to the user to navigate the front assembly unit through the cervicovaginal canal and locate the cervix. On reaching the cervix, a 360° view of the cervix can be displayed to the user. This allows the user to view the cervix and examine the cervix. Further, the disclosed device can provide guidance to the user to obtain images substantially around the cervical opening region. The images of the cervical opening region can be suitably analyzed to identify the transformation zone.
The disclosed device can provide navigational guidance to the user to view the identified transformation zone. The disclosed device can further provide guidance to the user to examine the identified transformation zone by suitably pointing to the identified transformation zone. Furthermore, the disclosed device can provide navigational guidance to the user to collect samples precisely from the identified transformation zone.
The disclosed device can thus result in correct, adequate and precise collection of samples from the transformation zone, which is the most appropriate site for collecting samples for cervical cancer screening. Thus the disclosed device can improve the accuracy of diagnosis of cervical cancer.
The disclosed device can i. assist the user in navigating the front assembly unit and locating the cervix ii. provide a plurality of images of the cervicovaginal canal and allow better visualization of the cervicovaginal canal iii. allow better visualization of the cervix iv. obtain 360° view of the cervix v. guide the user in obtaining images substantially around the cervical opening region vi. guide the user in identifying the transformation zone vii. guide the user in collecting samples from the identified transformation zone viii. reduce pain and discomfort to the woman ix. reduce the chances of injury to neighboring organs (e.g. urinary bladder, rectum) since the direction of insertion of the front assembly unit can be suitably adjusted based on the anatomical variations of the cervicovagial canal x. increase the accuracy of sample collection xi. allow even an untrained user (e.g. nurse) to perform cervical cancer screening test xii. improve the diagnosis of cervical cancer In essence, the disclosed device provides guidance to the user a) to identify the transformation zone and b) to collect samples precisely from the identified transformation zone by pointing at the identified transformation zone and enables safe withdrawal of the samples without any loss of samples.
The probability of collecting incorrect samples/inadequate samples is reduced since the disclosed device provides guidance to the user to collect samples precisely from the transformation zone. Hence, the collected samples from the transformation zone can improve the accuracy of cervical cancer screening.
In an embodiment, the navigational guidance unit comprises a location sensor for sensing a location of the front assembly unit inside the cervicovaginal canal of the subject; a labelling unit for labeling each obtained image with the sensed location from which the image is obtained; and a matching unit for matching a obtained image with an image from an image database and generating the navigational signals. This embodiment is advantageous in sensing the location of the front assembly unit in the cervicovaginal canal and associating the obtained image with the sensed location. The navigational signals are generated by matching the obtained image with an image from the image database. The navigational guidance can be suitably adapted and all possible eligible views of the cervicovaginal canal can be displayed to the user. This can help the user in examining the cervicovaginal canal.
Cervix is the lowest part of the uterus and opens into the vagina. The cervix generally measures around 2.5 - 3.0 cm in diameter and 3.0 - 5.0 cm in length. The direction of the cervix depends on whether the uterus is anteverted (anteriorly inclined) or retroverted (posteriorly inclined). The normal anatomic position of the cervix is angulated slightly downward and backward. The cervical canal is approximately 8 mm in width. Matching could involve a) checking for variations in the 2-d profile of the cervix b) checking whether the uterus is in anteversion and retroversion position. The available anatomical information about the cervix and the matching of the obtained images with the image from the image database can help the user in locating the cervix without much difficulty.
In an embodiment, the image database comprises a plurality of images of the cervicovaginal canal for each of a plurality of subjects, each image being classified based on the subject's age and parity. The word parity here refers to the number of live born children a woman has delivered. The image database can act as a baseline. It can help in analyzing the obtained images by comparing it with images in the database. Further, the image database can be periodically updated and aid in improving the diagnosis of cervical cancer.
In a further embodiment, the plurality of images are cross-referenced with one or more of anatomical description of the cervicovaginal canal geometrical measurements of the uterine cavity geometrical measurements of the cervicovaginal canal orientation of the uterus This embodiment can help the user i) to check for variations in the 2-d profile of the cervix ii) to check whether the uterus is in anterversion and retroversion position. The cross-referenced images could help the user in examining the cervicovaginal canal and locating the cervix without much difficulty.
In an embodiment, the navigational guidance unit further comprises a segmentation unit for segmenting the obtained images; a recognition unit for recognizing a target pattern in the segmented images, the target pattern being a pattern of two substantially concentric circular objects of the image; and a cervix locator for locating the cervix based on the recognized target pattern. This embodiment is advantageous in providing continuous navigational guidance to the user in navigating the front assembly unit and locating the external orifice (os) region. The cervix is generally divided into ecto-cervix and endo-cervix. The ecto- cervix is closer to the vagina and is generally 3 cm long and 2.5 cm wide. The ecto-cervix has a convex, elliptical surface has the external orifice (os) of the cervix which opens into the vagina. The external orifice (os) is bounded by two lips, an anterior and a posterior, of which the anterior is the shorter and thicker, although on account of the slope of the cervix, it projects lower than the posterior. The size and shape of the external orifice (os) and the ecto- cervix varies widely with age, hormonal state and whether the woman has previously given birth through vaginal canal or cesarian section.
This embodiment provides navigational guidance to the user to locate the external orifice (os) and the cervical canal region by making use of image processing techniques and available anatomical information about cervix. Generally, a normal cervical image and a cancerous cervical image are different and hence the pixel properties are different. Color and texture features could be used to segment the obtained images. Segmentation could result in two different segments namely i. one for external orifice (small segment in the center) and ii. the other for the tissue around the cervix making another region and encircling the external orifice.
The boundary of these two regions could represent two circle-like objects one inside the other. A pattern matching algorithm could determine the number of circle-like objects found in the images and their relative position. The relative position i.e. one inside the other could indicate the presence of the desired location of the cervix. The navigational guidance can: i. indicate to the user the direction to be followed for inserting the front assembly unit ii. make use of appropriate sounds to guide/warn the user while the front assembly unit is being maneuvered iii. display the image overlaid with navigational information (e.g. the navigational information could be generated by measurements and analysis of the obtained images) iv. based on whether the front assembly unit is moved away from the cervix or towards the cervix, the volume of the sound can be suitably increased/decreased (within acceptable limits) v. discourage the user from moving the front assembly unit away from the line of sight of the cervix vi. provide continuous guidance to the user to keep the front assembly unit always in line with the cervix and move it forward to reach the cervix vii. provide navigational indications using directional arrows In an embodiment, the identification unit comprises an image analysis unit for analyzing the obtained images for a change in at least one of color, texture or cell shape. This embodiment is advantageous in identifying the transformation zone which could be the most appropriate site for cervical sample collection. Generally in women who have had a vaginal birth, the ecto-cervix appears bulkier and the external orifice (os) is referred to as the endo- cervix. It varies widely in length and width, along with the cervix overall. The endo cervical canal measures 7 - 8 mm at its widest in woman of reproductive age. The junction between the ecto-cervix and the endo- cervix is known as the transformation zone due to change in lining cells from squamous type to columnar type. Cervical cancer most commonly arises from the transformation zone of the cervix.
After locating the cervix, the disclosed device could be directed towards the cervical opening (os) to obtain images of the external orifice (os) region and the cervical canal to identify the transformation zone i.e. the junction between the ecto-cervix and the endo-cervix. The obtained images could be analyzed for several features like morphology, color (mean color value of the pixels, histogram in HSV and RGB color space), texture (measure of roughness, statistics from co-occurrence matrix, wavelet coefficients) for identification of the junction.
As an illustrative example, the ecto- cervix is known to be smooth, rich pink in color; while the endo-cervix is not so smooth due to the presence of papillary cluster with interspaced clefts and orange to red in color. Hence, the obtained images could be analyzed for change in color (pink to orange/red) or change in texture (smooth to rough). Further, the ecto-cervix has flat squamous cells and the endo-cervix has tall columnar cells. The transformation zone could be identified based on such pre-determined characteristic variations. Further, the change in cell shape in the transformation zone could be identified (irregular, flat shape to defined columnar shape). A small magnification factor (e.g. 4x to 1Ox) could be used to facilitate the identification of the cell shapes.
The navigational guidance can provide the user i. information associated with the depth of insertion and prevent over insertion; suitable navigational information can be displayed based on whether the pattern of two concentric circle like objects is present or absent; if the depth of insertion is between 4.0 - 5.0 cms [<min(length of the vaginal canal)], then the user could be prompted to insert the front assembly unit in small incremental distances; If the maximum depth i.e. 10.0 cm is reached and the cervix is not identified, then a "cervix location failed/Retry" message could be displayed. Further, sounds could be used to warn the user during the entire navigation process ii. guidance to insert the front assembly unit at the tip of the external orifice (os) and the cervical canal for identifying the transformation zone iii. an arrow pointing at the identified transformation zone to help the user in examining the transformation zone In an embodiment, the sample collecting unit comprises a sample collector containing a spatula/brush enclosed in a capsule; and a sample collection guidance unit for providing navigational guidance to maneuver the spatula/brush towards the identified transformation zone for collecting the cytological samples from the identified transformation zone. Once the transformation zone is identified, the user can activate the sample collector and deploy the sample collector to collect the samples. Further, the identified transformation zone can be marked by drawing boundaries. The image can be displayed with an arrow pointing at the identified transformation zone. This could aid the user to deploy the spatula/brush to the transformation zone and collect the samples precisely from the transformation zone.
The disclosed sample collecting unit can improve cervical sample collection. Further, the sample collector could be designed to enclose the spatula/brush in a capsule. This could allow the user to enable safe, lossless collection of the samples from the transformation zone. This could result in collection of correct and adequate samples. This could improve the accuracy of diagnosis of cervical cancer screening.
In an embodiment, the sample collecting unit further comprises a reservoir unit for storing a fluid; and a control unit associated with the reservoir unit for spraying the fluid on the identified transformation zone.
This embodiment provides further navigation guidance to the user and enables better visualization of the identified transformation zone and the abnormal areas if any. This can further improve the collection of the samples from the identified transformation zone and result in correct and adequate sample collection. This can further improve the accuracy of diagnosis.
In an embodiment, the identification unit further comprises an overlay unit for overlaying the boundaries of the identified transformation zone on the obtained images thereby enabling display of the overlaid images. This could aid the user to precisely identify the transformation zone. This can result in collection of samples precisely from the identified transformation zone and improve the diagnosis of cervical cancer.
The further object of the present subject matter is realized by providing a cervicovaginal examination method comprising inserting a front assembly unit of a cervicovaginal examination device into cervicovaginal canal of a subject and obtaining images of the cervicovaginal canal of the subject; generating navigational signals, based on an analysis of the obtained images, for navigating the front assembly unit towards a cervical opening region; identifying a transformation zone, based on an analysis of the obtained images, the transformation zone being the junction between the ecto-cervix and the endo-cervix; and collecting cytological samples from the identified transformation zone.
BRIEF DESCRIPTION OF THE DRAWINGS
The above-mentioned aspects, features and advantages will be further described, by way of example only, with reference to the accompanying drawings, in which the same reference numerals indicate identical or similar parts, and in which:
Fig. 1 schematically shows an exemplary procedure for Pap smear sample collection; Fig. 2 shows an exemplary schematic block diagram of a device for performing cervicovaginal examination according to an embodiment of the present subject matter;
Fig. 3 shows an exemplary schematic block diagram of a navigational guidance unit according to an embodiment of the present subject matter;
Fig. 4 shows variation in the 2-d profile of an exemplary cervix when the uterus is in normal, anteversion and retroversion position (left to right);
Fig. 5 shows an exemplary schematic block diagram of the navigational guidance unit according to a still further embodiment of the present subject matter; Fig. 6 schematically shows the boundary around the external orifice (os) and the cervix;
Fig. 7 schematically shows exemplary schematic block diagram of an identification unit according to an embodiment of the present subject matter;
Fig. 8 schematically shows exemplary frontal and sagittal view of an exemplary cervix and vagina;
Fig. 9 shows an exemplary schematic block diagram of a sample collecting unit according to an embodiment of the present subject matter;
Fig. 10 shows an exemplary schematic block diagram of the sample collecting unit according to a still further embodiment of the present subject matter; and Fig. 11 schematically shows an exemplary flow chart illustrating the method of performing cervicovaginal examination according to an embodiment of the present subject matter.
DETAILED DESCRIPTION OF THE EMBODIMENTS Referring now to Fig. 1, cervical cytology sample collection procedure generally involves knowledge of the anatomical location of the cervix accompanied by manual visualization of the cervix. This is followed by scraping the cellular material from the uterine cervix. A piece of cotton or a brush or a small wooden stick is used to gently scrape the cervix. The material collected is then smeared on a slide or collected in a specific liquid phase for concentration and subsequent specific tests. In the cyto pathology laboratory the collected cells are stained. The stained cells are observed under a microscope to find out if they are abnormal. The smear is classified according to recommendations by the Bethesda system of classification of cervical smear abnormality. Human Papilloma Virus (HPV) detection can be done on the same sample if the cervical cells have been put in the liquid phase otherwise HPV testing may require a separate sampling at the same site.
The present method of cervical cytological sample may be difficult due to: a) variation in orientation of the uterus i.e. anteversion and retroversion, which affects the position of the external orifice (os) of cervix b) variation in the length of the cervixes in pregnant and non-pregnant women c) difficulty in finding the opening of the cervix d) difficulty in identification of the transformation zone due to its dynamic nature e) non-cooperation of the woman due to discomfort or painful procedure Hence, the collection of the cervical cytological samples even by an experienced user (e.g. gynecologist) could lead to a) incorrect collection of samples from inappropriate regions b) inadequate collection of samples c) imprecise collection of samples. This could result in inaccurate diagnosis.
The inventors have recognized that most of the cervical cancers originate in the transformation zone. Hence, optimal cervical specimen includes sampling of the squamous and columnar epithelium in the transformation zone. The inventors have recognized that the transformation zone of the cervix has to be sampled for effective and appropriate cervical cancer screening procedure like Pap smear/HPV testing.
Referring now to Fig. 2, the device 200 can aid a user in collecting the cytological samples from the transformation zone. The disclosed device 200 includes
I. a front assembly unit 210 housing an imaging module 212
II. a navigational guidance unit 230 III. an identification unit 240
IV. a sample collecting unit 250
The front assembly unit 210 is optimally shaped to match the cervicovaginal canal of a subject. The front assembly unit 210 houses an imaging module 212. As an illustrative example, the imaging module may include miniaturized camera. The camera can be configured to obtain images of the cervicovaginal canal.
The navigational guidance unit 230 could generate navigational signals, based on an analysis of the obtained images, for navigating the front assembly unit towards a cervical opening region. The identification unit 240 can be configured to identify a transformation zone, based on an analysis of the obtained images, the transformation zone being the junction between ecto-cervix and endo-cervix.
The sample collecting unit 250 can be configured to collect the cytological samples from the identified transformation zone.
The disclosed device 200 can provide navigational guidance to the user to navigate the front assembly unit 210 through the cervicovaginal canal of the subject and locate the cervix. On reaching the cervix, a 360° view of the cervix can be displayed to the user. This allows the user to view the cervix and examine the cervix. Further, the disclosed device 200 can provide guidance to the user to obtain images substantially around the cervical opening region. Furthermore, the disclosed device 200 can suitably analyze the images of the cervical opening region and identify the transformation zone.
The disclosed device 200 can provide navigational guidance to the user to view the identified transformation zone. The disclosed device 200 can further provide guidance to the user to examine the identified transformation zone by suitably pointing to the identified transformation zone. Furthermore, the disclosed device 200 can provide navigational guidance to the user to collect samples precisely from the identified transformation zone.
The disclosed device 200 can thus result in correct, adequate and precise collection of samples from the transformation zone, which is the most appropriate site for collecting samples for cervical cancer screening. Thus the disclosed device 200 can improve the accuracy of diagnosis of cervical cancer.
The disclosed medical device 200 can i. assist the user in navigating the front assembly unit and locating the cervix ii. provide a plurality of images of the cervicovaginal canal and allow better visualization of the cervicovaginal canal iii. allow better visualization of the cervix iv. obtain 360° view of the cervix v. guide the user in obtaining images substantially around the cervical opening region vi. guide the user in identifying the transformation zone vii. guide the user in collecting samples from the identified transformation zone viii. reduce pain and discomfort to the woman ix. reduce the chances of injury to neighboring organs (e.g. urinary bladder, rectum) since the direction of insertion of the front assembly unit can be suitably adjusted based on the anatomical variations of the vaginal canal x. increase the accuracy of sample collection xi. allow even an untrained user (e.g. nurse/health worker) to perform cervical cancer screening test xii. improve the diagnosis of cervical cancer In essence, the disclosed device 200 can provide guidance to the user a) to identify the transformation zone and b) to collect samples precisely from the identified transformation zone by pointing at the identified transformation zone and enabling safe withdrawal of the samples without any loss of samples.
The probability of collecting incorrect samples/inadequate samples is reduced since the disclosed device provides guidance to the user to collect samples precisely from the transformation zone. Hence, the collected samples from the transformation zone can improve the accuracy of cervical cancer screening.
Referring now to Fig. 3, the navigational guidance unit 230 comprises i. a location sensor 232 ii. a labeling unit 233 iii. a matching unit 234
The location sensor 232 can be configured to sense a location of the front assembly unit inside the cervicovaginal canal of the subject. The labeling unit 233 can be configured to label each obtained image with the sensed location from which the image is obtained. The matching unit 234 can be configured to match a obtained image with an image from an image database and generate the navigational signals.
This embodiment is advantageous in sensing the location of the front assembly unit in the cervicovaginal canal and associating the obtained image with the sensed location. The navigational signals are generated by matching the obtained image with an image from the image database. Hence, the navigational guidance can be suitably adapted and all possible eligible views of the cervicovaginal canal can be displayed to the user. This can help the user in examining the cervicovaginal canal.
Cervix is the lowest part of the uterus and opens into the vagina. The cervix generally measures around 2.5 - 3.0 cm in diameter and 3.0 - 5.0 cm in length. The direction of the cervix depends on whether the uterus is anteverted (anteriorly inclined) or retroverted (posteriorly inclined). The normal anatomic position of the cervix is angulated slightly downward and backward. The cervical canal is approximately 8 mm in width. Matching could involve i) checking for variations in the 2-d profile of the cervix as shown in Fig. 4 ii) checking whether the uterus is in anteversion and retroversion position. Fig. 4a shows the cervicovaginal canal in central position and Fig. 4b and Fig. 4c show the position of cervicovaginal canal in retroverted and anterverted position of the uterus. The available anatomical information about the cervix and matching the obtained images with the image from the image database can help the user in locating the cervix without much difficulty. The image database could include a plurality of images of the cervicovaginal canal for each of a plurality of subjects, each image being classified based on the subject's age and parity.
The word parity here refers to the number of live born children a woman has delivered. The image database can act as a baseline. It can help in analyzing the obtained images by comparing it with images in the database. Further, the image database can be periodically updated. The image database can aid in improving the diagnosis of cervical cancer.
Furthermore, the plurality of images could be cross-referenced with one or more of anatomical description of the cervicovaginal canal geometrical measurements of the uterine cavity geometrical measurements of the cervicovaginal canal orientation of the uterus
The cross-referenced images could help the user in examining the cervicovaginal canal and locating the cervix without much difficulty.
Referring now to Fig. 5, the navigational guidance unit 230 further includes i. a segmentation unit 342 ii. a recognition unit 346 iii. a cervix locator 348 This embodiment is advantageous in providing continuous navigational guidance to the user in navigating the front assembly unit and locating the external orifice (os) and the cervical canal region. The cervix is generally divided into ecto-cervix and endo- cervix. The ecto-cervix is closer to the vagina and is generally 3 cm long and 2.5 cm wide. The ecto-cervix has a convex, elliptical surface has the external orifice (os) of the cervix which opens into the vagina. The external orifice (os) is bounded by two lips, an anterior and a posterior, of which the anterior is the shorter and thicker, although on account of the slope of the cervix, it projects lower than the posterior. The size and shape of the external orifice (os) and the ecto-cervix varies widely with age, hormonal state and whether the woman has previously given birth through vaginal canal or cesarian section.
This embodiment provides navigational guidance to the user to locate the external orifice (os) and the cervical canal region by making use of image processing techniques and available anatomical information about cervix.
Generally, a normal cervical image and a cancerous cervical image are different and hence the pixel properties are different. Color and texture features could be used to segment the obtained images. Segmentation could result in two different segments as shown in Fig. 6, namely
I. one for external orifice (small segment in the center) and
II. the other for the tissue around the cervix making another region and encircling the external orifice.
The boundary of these two regions could represent two circle-like objects one inside the other.
A pattern matching algorithm could determine the number of circle-like objects found in the images and their relative position. The relative position i.e. one inside the other could indicate the presence of the desired location of the cervix. The navigational guidance can:
I. indicate to the user the direction to be followed for inserting the front assembly unit
II. make use of appropriate sounds to guide/warn the user while the front assembly unit is being maneuvered
III. display the image overlaid with navigational information (e.g. the navigational information could be generated by measurements and analysis of the obtained images)
IV. based on whether the front assembly unit is moved away from the cervix or towards the cervix, the volume of the sound can be suitably increased/decreased (within acceptable limits)
V. discourage the user from moving the front assembly unit away from the line of sight of the cervix VI. provide continuous guidance to the user to keep the front assembly unit always in line with the cervix and move it forward to reach the cervix, its opening and the cervical canal
VII. provide navigational indications using directional arrows Referring now to Fig. 7, the identification unit 240 includes an image analysis unit for analyzing the obtained images for a change in at least one of color, texture or cell shape. This embodiment is advantageous in identifying the transformation zone which could be the most appropriate site for cervical sample collection. Generally in women who have had a vaginal birth, the ecto-cervix appears bulkier and the external orifice (os) is referred to as the endo-cervix. It varies widely in length and width, along with the cervix overall. The endo cervical canal measures 7 - 8 mm at its widest in woman of reproductive age. The junction between the ecto-cervix and the endo- cervix is known as the transformation zone due to change in lining cells from squamous type to columnar type. Cervical cancer most commonly arises from the transformation zone of the cervix. After locating the cervix, the disclosed device could be directed towards the cervical opening (os) and to obtain images of the external orifice (os) and the cervical canal region to identify the transformation zone i.e. the junction between the ecto- cervix and the endo-cervix. The obtained images could be analyzed for several features like morphology, color (mean color value of the pixels, histogram in HSV and RGB color space), texture (measure of roughness, statistics from co-occurrence matrix, wavelet coefficients) for identification of the junction.
As an illustrative example, the obtained images could be analyzed for change in color (pink to orange/red) or change in texture (smooth to rough). As a further illustrative example, the ecto- cervix is known to be smooth, rich pink in color; while the endo-cervix is not so smooth due to the presence of papillary cluster with interspaced clefts and orange to red in color. Further, the ecto-cervix has flat squamous cells and the endo-cervix has tall columnar cells. The transformation zone could be identified based on such pre-determined characteristic variations.
Further, the change in cell shape in the transformation zone could be identified (irregular, flat shape to defined columnar shape). A small magnification factor (e.g. 4x to 1Ox) could be used to facilitate the identification of the cell shapes.
The identification unit 240 further includes an overlay unit 244. The overlay unit can overlay the boundaries of the identified transformation zone on the obtained images thereby enabling display of the overlaid images. The navigational guidance can provide the user i. information associated with the depth of insertion and prevent over insertion; suitable navigational information can be displayed based on whether the pattern of two concentric circle like objects is present or absent; if the depth of insertion is between 4.0 - 5.0 cms [<min(length of the vaginal canal), refer to Fig. 8], then the user could be prompted to insert the front assembly unit in small incremental distances; If the maximum depth i.e. 10.0 cm is reached (refer to Fig. 8) and the cervix is not identified, then a "cervix location failed/Retry" message could be displayed. Further, sounds could be used to warn the user during the entire navigation process ii. guidance to insert the front assembly unit at the tip of the external orifice (os) and the cervical canal for identifying the transformation zone iii. an arrow pointing at the identified transformation zone to help the user in examining the transformation zone
Referring now to Fig. 9, the sample collecting unit 250 includes i. a sample collector 254 containing a spatula/brush enclosed in a capsule ii. a sample collection guidance unit 256 for providing navigational guidance to maneuver the spatula/brush towards the identified transformation zone for collecting the cytological samples from the identified transformation zone.
Once the transformation zone is identified, the user can activate the sample collector and deploy the sample collector to collect the samples. Further, the identified transformation zone can be marked by drawing boundaries. The image can be displayed with an arrow pointing at the identified transformation zone. This could aid the user to deploy the spatula/brush to the transformation zone and collect the samples precisely from the transformation zone.
The disclosed sample collecting unit 250 can improve cervical sample collection. Further, the sample collector could be designed to enclose the spatula/brush in a capsule. This could allow the user to enable safe, lossless collection of the samples from the transformation zone. This could result in collection of correct and adequate samples. This could improve the accuracy of diagnosis of cervical cancer screening.
Referring now to Fig. 10, the sample collecting unit 250 further includes i. a reservoir unit 260 for storing a fluid (e.g. acetone) and ii. a control unit 262 associated with the reservoir unit 260 for spraying the fluid on the identified transformation zone
This embodiment provides further navigation guidance to the user and enables better visualization of the identified transformation zone. This can further improve the collection of the samples from the identified transformation zone and result in correct and adequate sample collection. This can further improve the accuracy of diagnosis.
Referring now to Fig. 11, the method 1100 for performing cervicovaginal examination includes the following steps: I. Step 1102 of inserting a front assembly unit of a cervicovaginal device into cervicovaginal canal of a subject and obtaining images of the cervicovaginal canal of the subject
II. Step 1104 of generating navigational signals, based on an analysis of the obtained images, for navigating the front assembly unit towards a cervical opening region
III. Step 1106 of identifying a transformation zone, based on an analysis of the obtained images, the transformation zone being the junction between the ecto-cervix and the endo-cervix and
IV. Step 1108 of collecting cytological samples from the identified transformation zone.
The present subject matter discloses a device that can provide guidance to the user a) to identify the transformation zone and b) to precisely collect samples from the identified transformation zone by pointing at the identified transformation zone and enables safe withdrawal of the samples without any loss of samples. The probability of collecting incorrect samples/inadequate samples is reduced since the disclosed medical device provides guidance to the user to precisely collect samples from the transformation zone. Hence, the collected samples from the transformation zone can improve the accuracy of cervical cancer screening.
In summary, a cervicovaginal examination device is disclosed. The disclosed device comprises a front assembly unit for housing an imaging module for obtaining images of a cervicovaginal canal of a subject; a navigational guidance unit for generating navigational signals, based on an analysis of the obtained images, for navigating the front assembly unit towards a cervical opening region; an identification unit for identifying a transformation zone, based on an analysis of the obtained images, the transformation zone being the junction between the ecto- cervix and the endo-cervix; and a sample collecting unit for collecting cytological samples from the identified transformation zone.
Although claims have been formulated in this application to particular combinations of features, it should be understood that the scope of the disclosure of the present subject matter also includes any novel features or any novel combination of features disclosed herein explicitly or implicitly or any generalization thereof, whether or not it relates to the same subject matter as presently claimed in any claim and whether or not is mitigates any or all of the same technical problems as does the present subject matter. While the subject matter has been illustrated in detail in the drawings and foregoing description, such illustration and description are to be considered illustrative or exemplary and not restrictive; the subject matter is not limited to the disclosed embodiments. Other variations to the disclosed embodiments can be understood and effected by those skilled in the art of practicing the claimed subject matter, from a study of the drawings, the disclosure and the appended claims. Use of the verb "comprise" and its conjugates does not exclude the presence of elements other than those stated in a claim or in the description. Use of the indefinite article "a" or "an" preceding an element or step does not exclude the presence of a plurality of such elements or steps. A single unit may fulfill the functions of several items recited in the claims. The mere fact that certain measures are recited in mutually different dependant claims does not indicate that a combination of these measures cannot be used to advantage. The figures and description are to be regarded as illustrative only and do not limit the subject matter. Any reference sign in the claims should not be construed as limiting the scope.

Claims

CLAIMS:
1. A cervicovaginal examination device (200) comprising: a front assembly unit (210) for housing an imaging module (212) for obtaining images of a cervicovaginal canal of a subject; a navigational guidance unit (230) for generating navigational signals, based on an analysis of the obtained images, for navigating the front assembly unit towards a cervical opening region; an identification unit (240) for identifying a transformation zone, based on an analysis of the obtained images, the transformation zone being the junction between the ecto- cervix and the endo-cervix; and a sample collecting unit (250) for collecting cytological samples from the identified transformation zone.
2. The device as claimed in claim 1, wherein the navigational guidance unit comprises: a location sensor (232) for sensing a location of the front assembly unit inside the cervicovaginal canal of the subject; a labelling unit (233) for labeling each obtained image with the sensed location from which the image is obtained; and a matching unit (234) for matching a obtained image with an image from an image database and generating the navigational signals.
3. The device as claimed in claim 2, wherein the image database comprises: a plurality of images of the cervicovaginal canal for each of a plurality of subjects, each image being classified based on the subject's age and parity.
4. The device as claimed in claim 3, wherein the plurality of images are cross- referenced with one or more of anatomical description of the cervicovaginal canal geometrical measurements of the uterine cavity geometrical measurements of the cervicovaginal canal orientation of the uterus.
5. The device as claimed in claim 2, wherein the navigational guidance unit further comprises: a segmentation unit (342) for segmenting the obtained images; a recognition unit (346) for recognizing a target pattern in the segmented images, the target pattern being a pattern of two substantially concentric circular objects of the image; and a cervix locator (348) for locating the cervix based on the recognized target pattern.
6. The device as claimed in claim 1, wherein the identification unit comprises: an image analysis unit (242) for analyzing the obtained images for a change in at least one of color, texture or cell shape.
7. The device as claimed in claim 1, wherein the sample collecting unit (250) comprises: a sample collector (254) containing a spatula/brush enclosed in a capsule; and a sample collection guidance unit (256) for providing navigational guidance to maneuver the spatula/brush towards the identified transformation zone for collecting the cytological samples from the identified transformation zone.
8. The device as claimed in claim 7, wherein the sample collecting unit (250) further comprises: a reservoir unit (260) for storing a fluid; and a control unit (262) associated with the reservoir unit for spraying the fluid on the identified transformation zone.
9. The device as claimed in claim 1, further comprising a display unit for displaying the obtained images to a user.
10. The device as claimed in claim 1, wherein the identification unit further comprises an overlay unit (244) for overlaying the boundaries of the identified transformation zone on the obtained images thereby enabling display of the overlaid images.
11. A cervicovaginal examination method (1100) comprising: inserting (1102) a front assembly unit of a cervicovaginal examination device into cervicovaginal canal of a subject and obtaining images of the cervicovaginal canal of the subject; generating (1104) navigational signals, based on an analysis of the obtained images, for navigating the front assembly unit towards a cervical opening region; identifying (1106) a transformation zone, based on an analysis of the obtained images, the transformation zone being the junction between the ecto-cervix and the endo- cervix; and collecting (1108) cytological samples from the identified transformation zone.
12. A software program for performing cervicovaginal examination, the software program comprising program code means configured to obtain images of a cervicovaginal canal of a subject on inserting a front assembly unit of a cervicovaginal examination device into cervicovaginal canal of the subject; generate navigational signals, based on an analysis of the obtained images, for navigating the front assembly unit towards a cervical opening region; identify a transformation zone, based on an analysis of the obtained images, the transformation zone being the junction between the ecto-cervix and the endo-cervix; and collect cytological samples from the identified transformation zone.
PCT/IB2010/052011 2009-05-13 2010-05-07 Cervicovaginal examination device WO2010131169A1 (en)

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