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WO2017083588A1 - Appareil et procédé pour détecter le cancer du col de l'utérus et la tuberculose - Google Patents

Appareil et procédé pour détecter le cancer du col de l'utérus et la tuberculose Download PDF

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Publication number
WO2017083588A1
WO2017083588A1 PCT/US2016/061438 US2016061438W WO2017083588A1 WO 2017083588 A1 WO2017083588 A1 WO 2017083588A1 US 2016061438 W US2016061438 W US 2016061438W WO 2017083588 A1 WO2017083588 A1 WO 2017083588A1
Authority
WO
WIPO (PCT)
Prior art keywords
opening
user
images
camera
liquid
Prior art date
Application number
PCT/US2016/061438
Other languages
English (en)
Inventor
Neil Shivraj DAVEY
Sonya Raj DAVEY
Samir DEVALARAJA
Divyansh AGARWAL
Grosh KENT
Lindsey FERNANDEZ
Alex KUBO
Thulani TSABEDZE
Original Assignee
Davey Neil Shivraj
Davey Sonya Raj
Devalaraja Samir
Agarwal Divyansh
Kent Grosh
Fernandez Lindsey
Kubo Alex
Tsabedze Thulani
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 Davey Neil Shivraj, Davey Sonya Raj, Devalaraja Samir, Agarwal Divyansh, Kent Grosh, Fernandez Lindsey, Kubo Alex, Tsabedze Thulani filed Critical Davey Neil Shivraj
Publication of WO2017083588A1 publication Critical patent/WO2017083588A1/fr

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B1/00—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor
    • A61B1/303—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor for the vagina, i.e. vaginoscopes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/43—Detecting, measuring or recording for evaluating the reproductive systems
    • A61B5/4306—Detecting, measuring or recording for evaluating the reproductive systems for evaluating the female reproductive systems, e.g. gynaecological evaluations
    • A61B5/4318—Evaluation of the lower reproductive system
    • A61B5/4331—Evaluation of the lower reproductive system of the cervix
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/0059—Measuring for diagnostic purposes; Identification of persons using light, e.g. diagnosis by transillumination, diascopy, fluorescence
    • A61B5/0075—Measuring for diagnostic purposes; Identification of persons using light, e.g. diagnosis by transillumination, diascopy, fluorescence by spectroscopy, i.e. measuring spectra, e.g. Raman spectroscopy, infrared absorption spectroscopy

Definitions

  • This invention is a self- screening tool for cervical cancer that is a method which combines the advantages of self-examination with that of professional analysis and interpretation of the results.
  • Cervical cancer is the leading cause of female cancer mortality in developing countries. Approximately 288,000 cervical cancer deaths occur every year worldwide, 86% in low-and middle-income countries alone (A. Sreedevi, R. Javed, and A. Dinesh, "Epidemiology of cervical cancer with special focus on India,” International Journal of Women's Health, vol. 7, pp. 405-414, 2015.).
  • CWs community health workers
  • nurses in low-income countries may use low- cost visual inspection with acetic acid and visual inspection with Lugol's Iodine (VIA/VILI) as an efficient screening tool for cervical cancer in place of Pap and HPV co-testing.
  • VIA/VILI Lugol's Iodine
  • VIA/VILI screening programs have lowered cervical cancer incidence and mortality since their introduction, they remain limited in effectiveness due to a number of implementation challenges which include:
  • the invention will eliminate the need to train CHWs in VIA/VILI, and increase access to and accuracy of screening in low-resource settings.
  • Our concept combines VIA/VILI screening with a robust machine learning algorithm to achieve high levels of sensitivity and specificity.
  • We propose an integrated system that is not only a screening tool, but also a method of linking high risk women to appropriate follow up and treatment through SMS interactions with local clinics.
  • the device may also be used in conjunction with the user's cell phone.
  • a simple indication of whether or not she has a precancerous or cancerous cervical lesion is provided. This would facilitate follow-up via encrypted SMS communications that (1) send directions for contacting and visiting nearby treatment centers to users with suspected positive results, and/or (2) forward collected images and results to local treatment centers, allowing providers to remotely confirm screenings, prioritize patients by severity, and contact patients to arrange follow-up as needed.
  • the invention is designed to make the screening process more comfortable than current offerings, which all require a healthcare provider to use a speculum to visualize the cervix.
  • a speculum is painful to many patients; surveys with physicians and patients have demonstrated decreased compliance to cervical exams due to the speculum (C. K. Bates, N. Carroll, and J. Potter, "The challenging pelvic examination,” Journal of General Internal Medicine, vol. 26, no. 6, pp. 651-657, 2011.).
  • the device is tailored to the female anatomy.
  • the woman inserts the tip of the device into her vaginal canal.
  • the self-insertion platform fits to expose her cervix to an endoscopic camera.
  • the camera conjugated with an LED light, captures an image of the cervix.
  • a small light on the outer case flashes green once a good image, that contains the entire outer surface of the cervix, has been taken. This allows the woman to adjust the device and retake the image if needed.
  • the instructions for this whole process which takes fewer than seven minutes, would be voice recorded and included with the device; by pressing a round red button on the case, the woman could hear the instructions in her preferred language as many times as she needs.
  • the device packages are equipped with acetic acid, Lugol' s Iodine, and ethanol for sterilization.
  • the invention would be compatible with any cellular device and to avoid any cost for the user, we are partnering with mobile companies to waive the cost of sending the SMS for the user.
  • the device can be self-administered by patients, improving privacy amid societal stigma towards causes of cervical cancer (K. E. Dyer, "From cancer to sexually transmitted infections: Explorations of social stigma among cervical cancer survivors," Human Organization, vol. 69, no. 4, pp. 321-330, 2010.; B. Nene, K. Jayant, S. Arrossi, S. Shastri, A. Budukh, S.
  • Figure 1 is schematic of a simplified cross-sectional view of a cervical cancer diagnostic device of an embodiment disclosed herein, with the device within the vaginal wall facing the cervix.
  • Figure 2 shows a detailed view of the cervical cancer diagnostic device.
  • Figure 3 shows the endoscope assembly of the cervical cancer diagnostic device.
  • Figure 4 shows a proximal view of the cervical cancer diagnostic device.
  • Figure 5 shows a system that provides a mechanism to spray the acetic acid within the vagina.
  • Figure 6 shows various embodiments of a self-insertion platform.
  • Figure 7 shows an algorithm for machine recognition of cervical lesions.
  • Figure 8 shows an example of the different paths that a system may use to
  • the term “a” and “an” refers to one or more. While the device of the embodiments herein is preferably used for visualization and diagnosis of a lesion or pathological abnormality within the vagina, the device can also be used for visualization and diagnosis of a lesion or pathological abnormality within the opening. Below, certain terms are clarified below.
  • vaginal Speculum In a normal dormant state, the walls of the vagina are situated in close juxtaposition about their axial center, thus preventing direct visual observation of the cervix uteri as required for medical examination.
  • the prior art includes a familiar type of device known as a vaginal speculum having two elongate metal blades pivotally joined together about a fulcrum, whereby parting of the blades after their initial placement in situ separates and holds apart the vaginal walls. The speculum is placed in the vagina with the blades collapsed together, and is advanced into the vagina.
  • Prior art traditional vaginal speculums must be inserted by a trained health practitioner.
  • the prior art traditional speculums used by gynecologists only isolate the cervix from vaginal tissue above and below it, and remain in place only when the woman is fully reclining, so they cannot be self-administered.
  • the speculum cannot be self-administered by a woman.
  • the necessity of visiting a clinic in order to have a gynecological examination is a barrier towards regular checkups.
  • the self-insertion platform in the context of vaginal visualization could be a device that can administered by a woman herself in her house.
  • the platform allows for the visualization of the cervix without using the traditional vaginal speculum.
  • Our designs use the following anatomical principle - nerve endings are greatest near the introitus (the first 1/3 of the vaginal canal), but are very minimal near the cervix (the latter 2/3 of the vaginal canal).
  • Endoscope Assembly An assembly that includes a camera and a light source that can be introduced in the vaginal canal. Any endoscope that includes a camera, optics, and a light source that is small enough to be introduced into the vaginal canal of an anatomically normal human user can be incorporated into this device, provided that the electronics are properly insulated and pose no risk of injury to the user.
  • Acetic Acid Spraying System A system for spraying acetic onto the cervix. This includes a manual pump system that sprays acetic acid from a tank or a motor/spring system with a syringe holding acetic acid.
  • a device comprising an inserted end that is configured to be inserted in an opening within a body of an user and a non-inserted end that is configured to be outside the opening, wherein the inserted end comprises an inserter that opens the opening, a camera, a light source and a nozzle for releasing a liquid into the opening, wherein the inserter is in a closed position at an entry of the opening and in an open position at a distal end of the opening so as to open the opening, wherein the non-inserted end comprises an electronic device configured to store and analyze images taken by the camera, and wherein the electronic device is further configured to control an amount of the liquid released through the nozzle into the opening, to validate quality of the images, and to perform an automated analysis of the images to diagnose a lesion or pathological abnormality within the opening.
  • the electronic device is further configured to verbally communicate the diagnosis.
  • the device comprises a cervical cancer diagnostic device.
  • the device is configured to diagnose the lesion or pathological abnormality within vagina, mouth, ear, nose or anus.
  • the device comprises an interface for wireless communication of data to and from the device.
  • the interface comprises a transceiver.
  • the non-inserted end comprises a processor, a battery, a device for transporting the liquid to the nozzle and data storage for images.
  • the device could further comprise a tank for storage of the liquid.
  • the inserter comprises an inflatable balloon, prongs, hallow cylinder or a flexible cup.
  • the liquid comprises a material that enhances visualization of the lesion or pathological abnormality within the opening.
  • the liquid comprises acetic acid or iodine.
  • the device comprises a multispectral analyzer.
  • Figure 1 demonstrates a simplified cross-sectional view of the cervical cancer diagnostic device (402) within the vaginal wall (401) facing the cervix (400).
  • the vaginal wall (401) is expanded to uncover the cervix (400) and enabling the device (402), which includes an endoscope and acetic acid spray, to visualize the cervix (400).
  • Figure 2 demonstrates detailed view of the cervical cancer diagnostic device.
  • Figure 2a shows the inside of the non-inserted end of the device, which includes the electrical wires from the endoscope to body of device (20), semi-flexible tube (21), acetic acid tube that transports the acetic acid to the nozzle (23), batteries (24), two syringes containing acetic acid (25), spring to deploy acetic acid (26), microcontroller and electronics (27), and button to activate spring (28).
  • the user could also be shown a live video of what is being captured by the endoscope assembly on a LCD screen.
  • the device features a programmable electronic controller with the processing and flash memory capacity to store and analyze the images.
  • the device features a 32-bit micro-controller that can process programming instructions written in C++, but any microcontroller available may be used.
  • the microcontroller is programmed with software that regulates the acetic acid spray, activation of the light source, and capture of the image of the cervix.
  • FIG. 2a Another embodiment of Figure 2a could include a larger acetic acid tank and a manual hand-pump to release the acetic acid; this embodiment would replace the syringe and spring with a tank and hand-pump.
  • the device can also be charged using an external charging port.
  • Figure 2b shows the inserted end of the device, including the endoscope assembly (201) and acetic acid nozzle (202).
  • the endoscope includes a camera (203) (lens and image sensor) and light source (204).
  • Figure 2c demonstrates the external features of the non-inserted portion of the device. It includes: an ergonomic handle (301), a speaker (302) that provides oral instructions in native languages, and two LCD lights (303) (green and red) that provide the result of the screening test. In addition, an LCD screen could be present.
  • Figures 3a and 3b detail the endoscope assembly (201), which in the present configurations refers to an assembly that includes a camera (203) and a light source (204) that can be introduced in the vaginal canal.
  • Any endoscope that includes a camera, optics, and a light source that is small enough to be introduced into the vaginal canal of an anatomically normal human user can be incorporated into this device, provided that the electronics are properly insulated and pose no risk of injury to the user.
  • the endoscope used in this device features an image sensor, an optic lens (203), a light source (204), and electrical cables (20) used to communicate with the rest of the device.
  • the electrical cables (20) connecting the device's controller electronics to the camera and the light source are contained in a semi-flexible tube that follows the curve of the vaginal canal and prevents the cables from contacting the vaginal wall or skin of the user.
  • This assembly may be referred to in this document by its individual components or as the endoscope assembly.
  • the image sensor used in this embodiment is a CMOS or CCD of the type typically used in digital cameras, cell phones, and medical instruments to capture and store an image in a digital format.
  • the image sensor is contained inside the assembly (201) that also contains the the light source (204), and the lens (203) such that the whole forms the portion of the device referred to as the endoscope.
  • the image sensor is fixed so that the light coming through the lens falls directly onto the light receiving portion of the sensor, and this image is continuously conveyed to the non-inserted portion of the device using electrical cabling.
  • the image sensor will be continuously recording, so that after the data is processed in the electronic controller located in the non-inserted portion of the device the user is shown a live video of what is being captured by the endoscope assembly.
  • the light source could be any light source that produces light in the visible spectrum and does not produce so much heat that it presents a safety risk to the user.
  • an LED light is preferable for this application because of its low cost, power consumption, size, and heat productions.
  • the light source (204) used is a white LED light with a brightness of 100 lumens, consuming approximately 3W of power and a color temperature of approximately 6500K.
  • the light is powered by its wired electrical connection (20) to the main non-insertive portion of the device.
  • the intensity of the light source can be controlled by the non-insertive portion of the device in order to provide the best visualization of the cervix possible.
  • the LED light intensity is varied through pulse width modulation through the electronic controller in the non-inserted portion of the device. Variation of the light intensity can be controlled by the user though the software interface, or automatically by the device's image processing software in order to generate the best possible picture.
  • the lens used in this device allows the endoscope to focus a minimum distance of 1- 2cm with a viewing angle of 140 degrees in order to capture an image of the entire cervix.
  • the optics do not allow the focal length of the camera assembly to be adjusted.
  • an adjustable focus for the camera could be used for this application.
  • the images captured by the present device are of comparable resolution and magnification to those used in optical colposcopic examination. These reflectance images can then be subsequently analyzed with computer programs to detect colposcopically important features, including but not limited to acetowhite, lesion borders, fine and coarse mosaic, punctuation and atypical blood vessels. It also allows computer programs to assess and determine the size of lesions, features, and inter-capillary distances.
  • Figure 4 demonstrates a proximal view of the device (the portion that faces the cervix).
  • the figure illustrates the (A) endoscopic apparatus (201) and (B) the acetic acid spraying system, showing nozzles (202).
  • the diameter of the entire assembly is approximately 1 inch, but can be narrowed or widened.
  • Figure 4a demonstrates an embodiment with the nozzles (202) in a circular pattern, enabling a equal and diffuse spread of acetic acid onto the cervix.
  • Figure 4b and 4a demonstrate embodiments with the nozzles (202) at two focused points.
  • Figure 5 demonstrates a system that provides a mechanism to spray the acetic acid.
  • a motor (M) drives a threaded rod (1) that is attached to the shaft of motor (2) via a coupling (8), a threaded nut (3).
  • the motor provides a linear force to the plunger of the syringe (12), forcing the acetic acid from the tank (4) through a flexible tube (11) to the nozzle at the end of the device that is inserted into the vaginal canal.
  • the motor (M) When the motor (M) is engaged, it pushes the plunger of the syringe (12) to create a spray of acetic acid at the nozzle, coating the cervix.
  • a tank of acetic acid (4) within the device is attached to the syringe with a one-way valve, allowing the syringe to be refilled when when the motor (M) is engaged in reverse.
  • the motor (M) is powered by batteries included within the body of the device, or by an optional power connector on the outside of the device that allows it to use electrical power from an external source.
  • a manually operated spray dispenser may be used to provide the acetic acid spray necessary to perform the procedure.
  • Figure 5b shows the acetic acid, hinge compressed tank (500), which is made of a squeezable plastic material.
  • the manual lever/push button (501) When the user pushes the manual lever/push button (501), the rotation of the manual lever at the hinge (502) causes the tank (500) to compress.
  • Figure 5c demonstrates the pump mechanism within the device with the acetic acid tube that caries the acetic acid to the nozzle (23).
  • the manual force from the user is used to generate the pressure necessary through the use of a handle and a spray mechanism used to dispense fluid. It is understood that any spray mechanism in commercial use may be adapted for this application, and that any manual spray mechanism used in this device does not change the primary claims of the patent.
  • Another embodiment uses a pump to create the pressure necessary to create a spray through the nozzle at the distal end of the tube.
  • Any pump that generates sufficient pressure to create a spray with a volume and pattern sufficient to coat the cervix can be used.
  • a peristaltic, medical grade pump would be used to isolate the fluid from the internal properties of the pump and prevent any contamination.
  • Figure 6 demonstrates various embodiments of the self-insertion platform.
  • the women in order for the women to visualize whether the inserter is facing the speculum, she can either use a hand held mirror or the software on the endoscope, which determines whether the sensor is viewing the cervix.
  • Embodiment 1 shows a balloon (600) that will inflate at the proximal end of the endoscope.
  • the balloon is toroid-shaped and surrounds the proximal end of the endoscope.
  • the deflated balloon and endoscope will be inserted into the cervix. Once the endoscope nears the cervix, the woman will use to the pump to inflate the balloon. This will allow expansion of the balloon, distention of the vaginal wall near the cervix.
  • the inflatable toroid could have rigid interior wall or an inflatable interior wall and an inflatable exterior wall that may be inflated with fluid or air after insertion to alleviate discomfort associated with expansion of the vaginal canal (the inflation will occur to a greater degree near the cervix).
  • the toroid balloon could be inflated to a maximum of 3 inches. Before removal, the inserter will be deflated.
  • Embodiment 2 ( Figure 6b) demonstrates a vaginal inserter comprising prongs (601) (at least two) that surround the endo scope/nozzle.
  • Embodiment 3 ( Figure 6c) demonstrates that the inserter is formed with an angular front orifice (602) wherein the front angle between the orifice and the axis of the inserter is designed to comfortably accept the cervix from the angle the cervix meets the vagina when the woman is upright (seated).
  • the orifice (602) edge has a rounded bead to avoid cutting the fragile vaginal tissue. Because of the angularity, the orifice can surround the cervix to facilitate its isolation from the impinging vaginal tissue.
  • the hollow cylindrical body (603) holds back the vaginal tissue which presses inward from all directions. The user can place his thumb on the inferior end of the hollow cylindrical body and place pressure downwards.
  • the inside diameter of the inserter is designed to be large enough to enable the user to observe the positioning of the inserter and use of the probes by employing a hand mirror.
  • the inserter is fabricated with thick side walls of polypropylene, polyethylene, or other suitable material.
  • the inserter is approximately seven inches in length (603) with an enlarged rounded bead about the periphery of the forward orifice (602).
  • the orifice (602) is formed at an angle of between twenty degrees and thirty degrees from a plane drawn parallel to the longitudinal axis of the inserter to facilitate easy application about the cervix.
  • Embodiment 4 ( Figure 6d).
  • the endoscope is fitted with an enlarged rubber cup (604) that expands the interior portion of the vagina in the region near the cervix.
  • the front cup (604) is chosen so that an average female can insert this front cup into her introitus and then into the vagina.
  • the outer portion of the front cup may be made from very flexible rubber of the type typically used in menstrual cups. Such flexible rubber would make the insertion of the enlarged cap into the introitus more comfortable.
  • Mating threads (605) on the endoscope apparatus and in the cap could allow various sizes of caps, depending of the female's vaginal canal size - to screw onto the endoscope apparatus.
  • the cap diameter could range from 1.5 to 3 inches.
  • Embodiments relate to a method comprising inserting the device disclosed above into the opening and diagnosing a diagnosis based on the lesion or pathological abnormality within the opening.
  • the method could further comprise sterilizing the device.
  • the method could further comprise releasing the liquid into the opening.
  • the method could further comprise image analysis of the images.
  • the method could further comprise guided positioning of the camera within the opening.
  • the guided positioning comprises positioning and/or focusing the camera either automatically and/or by the user so as to select a desired region of interest for imaging and to validate the quality of the images.
  • the method could further comprise the user of the diagnosis.
  • the method could further comprise transmitting the images and/or the diagnosis to a healthcare provider and/or an online server or data storage, and optionally further transmitting supplemental analysis results to the healthcare provider and/or the online server or data storage.
  • the method could further comprise inputting identification information of the user and optionally inputting social and medical history of the user.
  • the device can be sterilized using a variety of methods and in this section, examples of sterilization methods are provided.
  • One sterilization method could involve the entirety of the device being sealed from the outside environment in such a way that a medical-grade disinfectant solution can be used to wash the device.
  • the device is first cleaned by hand using water and soap, then immersed in a disinfectant solution.
  • Any of the various disinfectant solutions approved by the U.S. Food and Drug Administration for disinfection of medical endoscopes, surgical devices, or other medical devices inserted into the human body could be used to this end.
  • the entire device, including both the insertive and non-insertive portions, is immersed into the disinfectant solution.
  • the device In order to ensure that the device is not damaged by immersion in the disinfectant solution, the device is constructed of medical grade plastic resistance to commonly used disinfectant solutions, such as alcohols, chlorine and chlorine compounds, formaldehyde, glutaraldehyde, o/ /zo-phthalaldehyde, hydrogen peroxide, etc. Several key access ports and attachments on the device must be sealed in order to ensure this. [0056] In order to protect the device during sterilization, one embodiment includes the use of a rubber or silicone gasket to seal the cover of the device. Screws or any other means of attaching the cover can be used to ensure that the gasket maintains the appropriate seal.
  • the semi-flexible plastic tubing of the insertive portion of the device is attached to the non-insertable portion of the device using a threaded screw type fitting.
  • the semi-flexible tubing, of which the distal end is inserted into the vaginal canal, is permanently sealed to a fitting with external screw thread.
  • This fitting uses a gasket at the base of the threads to maintain a seal with the non- insertable portion of the device.
  • the distal, inserted end on the semi-flexible tube is permanently sealed with a continuous silicone sealant or caulk to the inserter.
  • Another embodiment includes placing the entire device in a clear plastic seal, like that of an underwater, water-proof camera.
  • This plastic seal can either be placed in a sterile solution or be disposed of between procedures.
  • Another sterilization method may allow for the inserted portion to be detached and immersed in the disinfectant separately.
  • a connection is provided between the end of the semi-flexible tube and the non-inserted portion of the device housing the controller electronics, pump, and batteries. Any waterproof electrical connector suitable for use in an underwater application can be applied here.
  • a female pin is inserted into a socket to make each electrical connection, and a rubber gasket is used to maintain continuity in the line containing the acetic acid.
  • the present device gives the user feedback indicating whether or not the entire cervical surface is within view of the camera.
  • One embodiment through which this can be accomplished is simply by displaying, via an onboard LCD screen, the image currently being captured by the device and instructing the user to adjust the position of the inserted device until the user can clearly see the entire [circular] surface of the cervix on the screen.
  • This approach however is necessarily user dependent and should be avoided in favor of automatic approach.
  • One such automatic embodiment could involve the use of an image preprocessing and segmentation method that removes lighting artifacts and uses a clustering algorithm to segment the cervical region of interest as described by A. Das, A. Kar, and D.
  • the endoscopic camera integrated into the present device must image the cervix at a resolution sufficient for subsequent identification of colposcopic features. This can be accomplished either by (a) using an endoscope capable of autofocusing or (b) analyzing images captured by the endoscope with a blur detection algorithm.
  • This algorithm could simply consist of computing the Fast Fourier transform (FFT) of the image, which outputs a list of frequencies present in the image, and computing the average of the 75% highest frequencies. A low average frequency would indicate that the image is blurry, while a higher frequency would indicate that the image is more in focus.
  • FFT Fast Fourier transform
  • Machine recognition of cervical lesions uses an onboard analysis algorithm to detect precancerous or cancerous lesions in cervical images after the application of acetic acid.
  • the analysis method (1) preprocesses the images to reduce the effects of lighting artifacts, (2) extracts measures of colposcopic anatomical features, and based on those features, (3) classifies the image as being positive or negative for the presence of disease.
  • This analysis preferably uses the reflectance image processing and classification approach described in U.S. patent application Ser. No. 11/0274338A1 for "Image analysis for cervical neoplasia detection and diagnosis", filed May 3, 2011, incorporated herein by reference.
  • This method outperformed physician conducted colposcopy in detecting the presence of disease, as confirmed by ground truth in the form of corresponding histology images, and so would likely outperform CHW-conducted VIA.
  • the image analysis approach used must, at minimum, output a single diagnostic for the entire image to be communicated to the user as a simple yes-no indicator for the presence of precancerous or cancerous cervical lesion.
  • Some analysis approaches are additionally able to specifically locate abnormal tissue regions on the cervix. This location information as well as other supplementary, clinically useful information output by the analysis can be stored on the device and subsequently forwarded to clinicians when follow-up treatment is sought.
  • Table 1 describes a comprehensive list of potential features that the machine learning algorithm could analyze.
  • Embodiments relate to a system comprising the device disclosed above and a device or database at a healthcare provider.
  • the system could further comprise an online server or data storage.
  • Other embodiments relate to a system comprising the device disclosed above and an online server or data storage.
  • Figure 8 demonstrates an example of the different paths that a system may use to communicate the results between the user, the device and the relevant health offices and personnel. Please note that between all the key players— i.e., the user, the device, the web server and the third parties (healthcare providers, offices, etc.)—the device may allow for bi- /multi-directional communication. It should be understood that this communication pathway is an example only; it should not be taken as the limiting scope of the present invention and should not be interpreted as limited to the described order or elements.
  • our device has the capacity to be a large public health monitoring system, which can be used to implement and track cervical cancer screening at a massive scale due to on-board processing.
  • the device i) allows the user to conduct a test, ii) using an automated algorithm analyzes the image, and iii) allows the user to
  • the patient may conduct the test and store the results on the device, and carry the device with the results stored therein to a medical personnel who can then examine the results of the test and guide the patient further.
  • the software interface of the device may allow the user to interact with the device in their local language of the area (or any other preferred language).
  • the user may begin the test and select "start test" by either voice-recognition or manually selecting a button on the device.
  • start test by either voice-recognition or manually selecting a button on the device.
  • the user may move through and select the desired option on a menu provided on a screen of the communication device.
  • the user may enter an
  • the device software may allow the user or an acquaintance of the user to enter patient-specific details and identify patient conditions prior to starting the test.
  • the software-based client applications will provide displays to the user related to what the result of the test was, and what the next steps for the user may be if further action or medical care is required.
  • the displays or prompts provided by the client application may also instruct the user on the various steps required to comprehensively perform the test. Various tasks may be performed and completed by the user. All the pertinent information can be inputted and stored in memory of the communication device.
  • the client application may provide a finish test prompt in a similar multitude of ways as was the case for starting a test.
  • the tracking and communication programs may allow for communication between the user or a medical staff, and vice- versa.
  • the information captured by the device can be transmitted to an office administration server system over a communication network such as the Internet.
  • the office administration or other receiving party may be alarmed via a text message or e-mail notification if the device detects a result that deviates from normal.
  • the physician or medical staff member can manage the patient's care appropriately.
  • the medical staff may also compare the user's results from their past experience, or start a new log on the server which they can then refer to and/or update with every future use of the device.
  • the data information inputted and accumulated at the client communication device is transmitted through a
  • the server system may include a web portal computer for establishing proper communication through the Internet or World Wide Web.
  • the software programs may also be associated with one or more computer-based communication devices and could allow for building a patient visit record which may get updated with each successive use of the device.
  • Each device may have the additional capability to store the patient's record from previous usage in a manner that would allow for easy physical communication of the record.
  • the device in its current embodiment may have a platform for an SD card or a USB to allow easy access to the data directly from the device.
  • Time and date information are recorded as well as the information accumulated in relation to the visit.
  • Such information associated with the visit may also be stored in memory at the computer-based communication device for transmission to a remote server system.
  • the overall system of the device provides for electronic data collection and reporting.
  • a global positioning system GPS
  • the communication device may incorporate a digital or electronic clock.
  • the GPS application allows for monitoring the use of the device by the patient.
  • the GPS allows tracking, from the remote server system (or alternative monitoring location), of the position or location of the field workers as they possess and carry the device with them.
  • the GPS application determines the location coordinates of the
  • Editing or approval of information relating to visits may be performed in an automated fashion by the web portal server or by other computer devices associated therewith.
  • the records established with completed tests (for example if a user tested himself or herself a year ago and is now re-testing himself or herself) are archived at the server system.
  • the remote server system may further provide reporting capabilities and may allow communication of a dynamic, personalized electronic healthcare record to a healthcare provider or for receipt an electronic system at the receiving end.
  • the receiver may convey back treatment suggestions, if any, or reach out to the patient or their family through any other means.
  • the device may be capable of communicating data over the Internet, or may alternatively be any other type communication device capable of transmitting data.
  • the communication device is preferably a software-based device that has an associated memory for storage of data communication software.
  • the communication and tracking software can be operated on various types of mobile or cellular telephones.
  • the results from the test are electronically sent by the device over the Internet (or may use other communication network) to a server system. This realtime communication of patient records and results from the screening test allows a medical staff on the receiving end to monitor the use of the device and may also reduce errors while improving patient outcomes.
  • the device may also have the feature of being attached to an external computer, laptop or some other display unit for retrieving and viewing the recorded information.
  • the device allows a healthcare provider or an administrator to review the user's records together with the user to make a treatment plan for the user, or recommend regular screening in the future if the results do not indicate a need for treatment.
  • the user and the healthcare provider may also view and take note of the results displayed on the device after they perform the test.
  • the device may include software, hardware, firmware, or a combination of these, in order to provide the desired functionality afforded by various embodiments of the present invention, and additionally to allow the device to act as a client device with respect to the server system. Consequently, the device may contain multiple resident software applications for performing the different tasks, including data storage. For example, the device may have a software for data analysis, another software to allow the user to send an SMS text message directly to the nearest healthcare provider based on the GPS location, and another to allow for real-time asynchronous communications between a medical personnel and the user.
  • US20100016668A1 Medical device for discreetly performing a routine vaginal examination
  • WO2012123881 A2 Medical instrument for examining the cervix
  • CN205055167U Novel multi -functional endoscopic surgery spray line
  • Table 1 List of cervical features included in American Society for Colposcopy and Cervical
  • Normal No colposcopic evidence of a cervical lesion. Normal includes squamous
  • epithelium columnar epithelium, squamous metaplasia, nabothian cysts, glandular hyperplasia, and gland openings.
  • Squamous metaplasia turns white after the application of acetic acid, but its peripheral margin tends to be indistinct and to blend into the adjacent squamous epithelium.
  • mucosa around the external as appears red prior to the application of acetic acid has been called eversion, ectropion, or ectopy. Its surface presents longitudinal ridges and multiple villus-like projections. After the application of acetic acid, the tips of these villi may turn white, indicating the earliest manifestations of metaplasia.
  • postmenopausal patient such as petechiae, pale, thin, or poorly glycogenated epithelium, and traumatic abrasions.
  • CIN Cervical Intraepithelial Neoplasia
  • Low-grade lesions have faint aceto white changes, indistinct (feathered or finely scalloped), angular or irregular margins (similar to geographic features on a map (geographic margins)] and may have fine (small diameter) vessel patterns.
  • Condyloma Clinically evident exophytic HPV infection. Because condylomas have a distinct colposcopic appearance, they are given their own category in this presentation.
  • High-grade lesions have intermediate or dense acetowhite changes, straight and sharp well-demarcated margins and may have coarse (large diameter) vessel patterns. The highest- grade lesions may have edges that detach from the underlying stroma and roll back upon themselves (see rolled edge). Lesions that show an internal border between two lesions are almost always high-grade, with the peripheral area representing a minor-grade lesion and the central area a high-grade lesion
  • Cancer - Disease invading the cervical stroma Colposcopic findings consistent with cancer include atypical vessels, ulceration, discoloration, friability, bleeding and irregular surface contour.
  • Faint acetowhite changes A transient and transparent white color change that occurs after the application of a diluted solution of acetic acid to the cervical epithelium likely due to a temporary dehydration of epithelial cells. Faint acetowhite changes can be seen in metaplastic epithelium and inflamed epithelium. It is also present in lesional epithelium and is normally associated with low-grade CIN.
  • Snow (shiny) acetowhite changes A transient white color change, likely due to a temporary dehydration of epithelial cells, resembling the color of snow or that of an intensely shiny surface that occurs after the application of a diluted solution of acetic acid to the cervical epithelium. This change normally occurs with condyloma or low-grade CIN lesions.
  • Dense (dull) acetowhite changes A transient color change, likely due to a temporary dehydration of epithelial cells, resembling an oyster shell that occurs after the application of a diluted solution of acetic to the cervical epithelium. This change normally occurs with high-grade CIN.
  • the epithelium may also appear to be thickened.
  • Leukoplakia A white, keratotic plaque seen prior to the application of a diluted solution of acetic acid. Leukoplakia reveals hyperkeratosis on biopsy and is a nonspecific finding that may be caused by trauma, infection, HPV or even cancer, but in most cases the etiology of leukoplakia is unknown.
  • Nonspecific vascular changes - Vessels that do not form any particular pattern and are not associated with disease.
  • Punctuation - A vascular pattern of red dots in a field of acetowhite epithelium.
  • the red dots are the tips of capillary loops visible through the colposcope.
  • Punctuation may display fine (small diameter) or coarse (large diameter) vessel patterns. Punctations associated with metaplasia, flat condyloma or low-grade CIN, tend to display fine dots that are close together (small intercapillary distance). Punctations associated with high- grade CIN tend to display coarse dots that are irregularly spaced and farther apart (large intercapillary distance).
  • Red dots on a pink or red mucosa after the application of a diluted solution of acetic acid are usually manifestations of an inflammatory condition such as Trichomonas or some other type of vaginitis.
  • Mosaic - A vascular pattern of acetowhite tiles or cobblestones outlined in red. The red outlines are confluent arborizing capillary loops visible through the colposcope.
  • Mosaic may display fine (small diameter) or coarse (large diameter) vessels.
  • Mosaic associated with metaplasia, flat condyloma or low-grade CIN tends to be small (small tiles whose size and shape is fairly uniform that are surrounded by vessels with a small diameter).
  • Mosaic associated with high grade CIN tends to be large (large tiles whose size and shape wary that are surrounded by vessels with a large diameter).
  • Atypical vessels - Vessels that are not typical. They are irregular and dilated and can be nonbranching with abrupt changes in direction. Sometimes they can almost appear to be sitting on the surface of the epithelium. They can be in the shape of commas, corkscrews, starbursts or squiggles. They are normally associated with cancer, but can sometimes be associated with high-grade CIN or pre-invasive glandular lesions. They may also appear in cervicitis and other non-neoplastic epithelium. Ulceration - Exposed stroma. The overlying epithelium is gone and the underlying stroma is visible. It is important to distinguish ulceration associated with disease from that that which was caused by trauma. Trauma related ulcers could be caused by insertion of a speculum, use of Pap smear devices, or tampons.
  • Indistinct (feathery or finely scalloped) margin The border of the acetowhite change that is normally feathered or finely scalloped. It is not sharp, straight or geographic. This is a typical finding of low-grade CIN.
  • Satellite lesion - An acetowhite demarcated area usually geographic in shape that is found on the portio of the cervix and is not connected to the transformation zone. Satellite lesions often show only nonspecific histological changes but when they are associated with dysplastic change it is typically low-grade CIN.
  • Sharp margin - The border of CIN that is well defined and usually straight rather than geographic in appearance. This is a typical feature of high-grade CIN.
  • the peripheral lesion is normally a low grade CIN and the proximal lesion is normally a high-grade CIN.
  • the surface epithelium may be raised, spiked, depressed or have some other irregularity. This is a typical feature of cancer but can appear in a normal condition such as glandular hyperplasia. Condyloma will always have an irregular surface contour.
  • Pregnancy changes - Normal cervical changes associated with pregnancy. Typical features of a normal cervix in pregnancy include venous engorgement, decidual changes, gaping gland openings, waginal wall laxity and very active metaplasia.
  • Polyps Small to large sized, pedunculated masses. Most originate from the endocervix (endocervical polyps) but they can also be of endometrial or waginal origin.

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Abstract

Des modes de réalisation de la présente invention concernent un dispositif comprenant une extrémité insérée qui est configurée de manière à être insérée dans une ouverture dans un corps d'un utilisateur et une extrémité non insérée qui est configurée de manière à être à l'extérieur de l'ouverture, l'extrémité insérée comprenant un dispositif d'insertion qui ouvre l'ouverture, une caméra, une source de lumière et une buse pour libérer un liquide dans l'ouverture, le dispositif d'insertion étant dans une position fermée à une entrée de l'ouverture et dans une position ouverte à une extrémité distale de l'ouverture de manière à ouvrir l'ouverture, l'extrémité non insérée comprenant un dispositif électronique configuré pour stocker et analyser des images prises par la caméra, et le dispositif électronique étant en outre configuré pour réguler une quantité du liquide libéré par l'intermédiaire de la buse dans l'ouverture, valider la qualité des images et effectuer une analyse automatisée des images pour diagnostiquer une lésion ou une anomalie pathologique dans l'ouverture.
PCT/US2016/061438 2015-11-10 2016-11-10 Appareil et procédé pour détecter le cancer du col de l'utérus et la tuberculose WO2017083588A1 (fr)

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Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN109543719A (zh) * 2018-10-30 2019-03-29 浙江大学 基于多模态注意力模型的宫颈非典型病变诊断模型和装置
WO2019098415A1 (fr) * 2017-11-16 2019-05-23 주식회사 버즈폴 Procédé permettant de déterminer si un sujet a développé un cancer du col de l'utérus, et dispositif utilisant ledit procédé
WO2022058779A1 (fr) * 2020-09-21 2022-03-24 Pontificia Universidad Javeriana, Seccional Cali Dispositif, système et méthode pour la détection précoce du cancer cervical

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WO1998052479A1 (fr) * 1997-05-23 1998-11-26 Fiber-Tech Medical, Inc. Procede et appareil d'ablation par atomisation cryogenique de la muqueuse gastro-intestinale
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WO2012151073A2 (fr) * 2011-05-03 2012-11-08 Endosee Corporation Procédé et appareil pour hystéroscopie et biopsie de l'endomètre
KR20140016030A (ko) * 2012-07-30 2014-02-07 가톨릭대학교 산학협력단 부인과용 탈부착형 내시경 장치

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KR970020052A (ko) * 1995-10-12 1997-05-28 김광호 내시경 수술시스템 주변장치 및 그 제어방법
WO1998052479A1 (fr) * 1997-05-23 1998-11-26 Fiber-Tech Medical, Inc. Procede et appareil d'ablation par atomisation cryogenique de la muqueuse gastro-intestinale
US20110028790A1 (en) * 2004-09-24 2011-02-03 Vivid Medical, Inc. Disposable endoscopic access device and portable display
WO2012151073A2 (fr) * 2011-05-03 2012-11-08 Endosee Corporation Procédé et appareil pour hystéroscopie et biopsie de l'endomètre
KR20140016030A (ko) * 2012-07-30 2014-02-07 가톨릭대학교 산학협력단 부인과용 탈부착형 내시경 장치

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* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2019098415A1 (fr) * 2017-11-16 2019-05-23 주식회사 버즈폴 Procédé permettant de déterminer si un sujet a développé un cancer du col de l'utérus, et dispositif utilisant ledit procédé
CN109543719A (zh) * 2018-10-30 2019-03-29 浙江大学 基于多模态注意力模型的宫颈非典型病变诊断模型和装置
WO2022058779A1 (fr) * 2020-09-21 2022-03-24 Pontificia Universidad Javeriana, Seccional Cali Dispositif, système et méthode pour la détection précoce du cancer cervical

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