Automated process for controlling in vivo examination of the cervix and collecting image data related thereto

Abstract

A colposcopy instrument (including a display screen) is controlled by a specific set of steps defined in software to perform a colposcopy following a defined protocol. The software is also used to control the features of an attached camera so that consistent digital images are recorded. The integrated software prompts the medical personnel performing the colposcopy procedure to capture relevant images in an automatic sequence, which automatic sequence includes, for example, capturing a sequence of images after applying acetic acid to the cervix. The displayed user interface guides the individual through the examination through a series of easy-to-understand on-screen prompts to capture specific key images during the examination. The process is automatic once started and does not require the individual performing the examination to make any decisions as to whether to record a certain image.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This application claims the benefit of U.S. Provisional Application No. 62 / 909,878, filed on October 3, 2019, which is incorporated herein by reference. Technical Field

[0003] The present invention relates to in vivo examination of the cervix during precancer screening / colposcopy procedures and, more particularly, to the use of software controlled tools to assist the individual performing the procedure to follow a preferred set of procedural steps. Background Art

[0004] Abnormal growths of potentially precancerous cells in the cervix exhibit certain morphological features that can be identified during colposcopy, a procedure that examines an illuminated, magnified view of the cervix (as well as the vagina and vulva). An acetic acid (and possibly iodine) solution may be applied to the surface of the cervix to improve visualization of specific abnormal growths.

[0005] Almost all precancerous lesions of the cervix will turn a transient opaque white color after application of 3%-5% acetic acid. The whitening process (also called "acetoblanching") occurs over time and is visible to the naked eye (or with the aid of low-grade magnification). Therefore, the individual performing the colposcopy is able to subjectively differentiate between abnormal and normal tissue.

[0006] However, due to this subjective nature of colposcopy, the accuracy of colposcopy has been found to be highly dependent on the experience and expertise of the medical staff. In addition, the specific process steps used during colposcopy are not well controlled, so it may be difficult to reproduce the same results for a given patient. Most traditional colposcopy does not provide quantitative diagnostic information, but instead relies on the experience and vision of the examiner, which can lead to high variability (subjectivity) and errors in diagnosis.

[0007] The problem is only exacerbated when the examination occurs in a part of the world where there is little medical training and where there may be no one other than the technician to perform the procedure. Summary of the invention

[0008] The present invention addresses the problem of variability that exists in colposcopy in the form of a software controlled tool to assist individuals performing the procedure in following a preferred set of procedural steps.

[0009] As discussed above, the lack of guided processes and prompts in practice and in the field has been found to result in a high degree of variability in image capture and protocols employed in different screening settings around the world. The unique software and guided processes of the present invention, as described in detail below, implement standardization and consistency in a highly user-friendly manner so that images that convey important diagnostic features of tissue are captured and can be more reliably compared and evaluated between physicians and patients.

[0010] According to the present invention, an exemplary colposcopy instrument is controlled by a set of specific steps defined in software to follow a defined protocol for performing a colposcopy. The software is also used to control the features of a built-in camera so that consistent digital images are recorded. The integrated software prompts the medical personnel performing the colposcopy procedure to capture relevant images in an automatic sequence, including, for example, capturing a series of images after applying acetic acid to the cervix.

[0011] An associated user interface guides the individual performing the examination through a series of easy to understand screens, prompting the capture of specific key images during the examination. The process is automatic once initiated and does not require the individual performing the examination to make any decisions as to whether or not to record a particular image. Still images (and possibly video, in an exemplary embodiment of the invention) associated with acetic acid uptake by the tissue, including images taken before, during, and after the application of acetic acid, are displayed to the medical staff at the conclusion of the procedure. The rate of acetic acid uptake by the cervix over a certain time interval may be an important feature in aiding the diagnosis of cervical precancer. Images of the squamocolumnar junction (SCJ) may also be recorded, as well as images after the application of Lugol's iodine.

[0012] Advantageously, the recorded image (and video) information can be uploaded from the device to a medical diagnostic platform accessible to networked clinicians worldwide. By providing a standardized procedure, the guided colposcopy procedure of the present invention provides more consistent results that are less susceptible to the skill level of the individual performing the examination and ensures that all relevant information is collected during each examination.

[0013] An exemplary embodiment of the present invention takes the form of a method for performing a guided colposcopy procedure utilizing a combination of a digital camera and a computer-controlled colposcopy instrument including a display screen, the method comprising at least the following steps: (1) activating the computer-controlled colposcopy instrument to display a plurality of selectable options associated with a defined set of steps in the guided colposcopy procedure, the defined set of steps including at least one step of performing acetic acid uptake; (2) selecting a value for each of the plurality of selectable options displayed on the display; and (3) commanding the computer-controlled colposcopy instrument to activate the digital camera to present a region of interest (ROI) of the cervix on the display. (4) presenting a set of timeline milestones as an overlay on the digital image, each milestone being associated with an individual step in the defined set of steps in a guided colposcopy procedure; (5) prompting medical personnel through each individual step in performing the guided colposcopy procedure, changing the visual display of each milestone as the associated step is completed; (6) acquiring digital images of the cervical ROI in accordance with prompts from a computer-controlled colposcopy instrument; and (7) creating a final report of the colposcopy procedure in a tangible form, the final report including at least a list of selected options and a plurality of digital images of the cervical ROI captured during the procedure.

[0014] Other and further aspects and features of the present invention will become apparent during the course of the following discussion and by reference to the accompanying drawings. BRIEF DESCRIPTION OF THE DRAWINGS

[0015] Now referring to the accompanying drawings,

[0016] Figure 1 Depicts an initial screen that may be presented to the provider at the beginning of a guided colposcopy procedure;

[0017] Figure 2 An alternative initial graphical display that may be presented is illustrated, it being understood that a variety of other introductory screens may be presented at the beginning of a guided colposcopy procedure;

[0018] Figure 3 An example of the initial patient screen that appears when selecting an appropriate individual for the current procedure is shown;

[0019] Figure 4 is an exemplary screen shot showing a set of selectable options that may be controlled by the medical personnel performing the procedure, the set of selectable options including selection of an acetic acid ingestion interval (and a specific acid concentration);

[0020] Figure 5is a screen shot depicting an exemplary set of camera settings that may be adjusted by the medical staff performing the procedure (or automatically controlled by the guided colposcopy process itself);

[0021] Figure 6 is a screen shot of a display associated with an initial step in an exemplary guided colposcopy procedure;

[0022] Figure 7 depicts a screen shot of an exemplary "image check" step that may be included to confirm camera settings before image capture begins in accordance with the principles of the present invention;

[0023] Figure 8 is a screen shot of a display associated with the next step in a guided colposcopy procedure, the step being represented as "Apply Saline Solution";

[0024] Fig. 9 including a screenshot of the guided colposcopy procedure displayed next, prompting the medical staff to apply acetic acid and begin recording images (and / or video) at a set time during a predetermined uptake interval;

[0025] Fig.10 illustrates the continuous capture of digital images during the acetic acid uptake step of a guided colposcopy procedure;

[0026] Fig.11 is a screenshot of a guided colposcopy procedure at the completion of the acetic acid uptake step, which prompts the medical staff to locate the SCJ;

[0027] Fig.12 Contains screen shots associated with an optional biopsy procedure that may be included in a guided colposcopy procedure under the initiation and control of medical personnel;

[0028] Fig.13 is an exemplary screen shot of subsequent milestones along a guided colposcopy procedure, prompting the medical staff to apply Lugol's iodine (if that step has been "selected" to be included in the procedure);

[0029] Fig.14 is a screenshot illustrating a procedure following application of Lugol's iodine, the screenshot including capture of digital images under different camera settings including filters of different colors;

[0030] Fig.15 is a screenshot depicting the completion of a guided colposcopy procedure that shows all milestones of the steps completed in the procedure and includes prompts for entering the steps for preparing the final report;

[0031] Fig.16 illustrates an options screen that may be displayed in which medical personnel are requested to confirm a request to "end" the procedure;

[0032] Fig.17 illustrates an exemplary final report associated with a guided colposcopy procedure, which final report will be stored as part of the patient's electronic file and may also be printed out if necessary;

[0033] Fig.18 An exemplary colposcopy instrument that can be used to perform a guided colposcopy procedure according to the present invention is illustrated, the exemplary colposcopy instrument comprising a tablet device (with the guided procedure installed in the device) and an associated digital camera peripheral device under the control of the tablet device; and

[0034] Fig.19 Include Fig.16 Front and rear views of the instrument, which is mounted on a portable rack and can be moved from one examination room to another when necessary. DETAILED DESCRIPTION

[0035] Figure 1-Figure 17 A series of screen shots are presented that are displayed to the individual performing the examination (hereinafter sometimes referred to as the "medical personnel"), guiding him / her through the examination process. In accordance with the principles of the present invention, a software-based guided colposcopy procedure is loaded into a portable computing device, such as a tablet computer, having a touch screen (or keyboard) control that helps make the procedure easy to follow for those with little training or experience. The computing device includes a display that not only provides graphical prompts to guide the sequence of steps that form the procedure, but also displays an image of the cervix being examined captured by an associated camera. The following will be combined with the present invention to provide a software-based guided colposcopy procedure. Figure 18 to Figure 19 Exemplary arrangements of components that form embodiments of automated colposcopy instruments are discussed.

[0036] An advantage of the present invention is that once a set of initial process parameters (described below and Figure 4 The rest of the process is automated, and the digital images recorded during the examination are truly independent of the expertise level of the individual performing the examination, as long as the person performing the examination is able to position the camera in front of the cervix.

[0037] Figure 1An initial screen is shown which may be displayed when a medical practitioner logs in and enters a guided procedure to enable an automated colposcopy procedure. This screen displays an alphabetical list of all registered patients (obviously, the list can be scrolled to show surnames A to Z). For purposes of explanation, it is assumed that the medical practitioner performing the guided colposcopy procedure selects the patient identified by the number 10. Alternatively, if no information for the current patient can be found, the medical practitioner activates the "add patient" button 12 and is then presented with a patient "inclusion" screen in which the individual's details may be entered. Figure 2 An alternative initial screen is depicted that may be used, where instead of being presented with a complete list of existing patients, the medical professional enters identifying information (e.g., patient name, patient ID number, etc.) into a search bar 14. Likewise, if information for a current patient cannot be found, an "add patient" button 12 may be activated to allow new patient information to be added to a database associated with the system. Figure 1 and Figure 2 The configuration shown in is to be considered exemplary only, and it should be understood that various other visualizations may be used when an authenticated user logs into a software-guided colposcopy procedure.

[0038] Figure 3 An example of an initial patient screen that appears when a particular individual is selected is shown. In this particular configuration, the display includes a screen area 20 that can illustrate previous results, such as from a previous examination. This is illustrated as an icon 26 in the screen area 20. In this case, the icon 26 is associated with an electronic file of the previous examination for review by the medical staff before continuing with the procedure. Other patient histories may also be displayed. Assuming that all displayed information is correct, the medical staff then activates the actual colposcopy procedure using button 22, which can be identified by a label such as "Start Colposcopy". It should be noted that for the purpose of explaining the principles of the present invention, the phrases "colposcopy", "cervical precancer screening" and "colposcopy procedure" may be used interchangeably.

[0039] In such Figure 3 In the particular configuration shown, the medical staff can use another option, shown here as a "camera" button 24. As will be discussed in more detail below, the instrument used to perform the procedure includes a camera that takes photos (and possibly videos) of the procedure. If the medical staff does not want to perform the entire colposcopy procedure, but only wants to take a few photos (perhaps as part of a follow-up visit), the procedure itself can be bypassed and the automated program can be instructed to enter a process that allows any desired number of digital images to be recorded.

[0040] For the sake of discussion, it is assumed that the medical staff has activated button 22 to initiate the guided colposcopy procedure. Figure 4The screenshot shown is presented to the medical staff. This initial screen presents the only available selectable "options" to the medical staff, helping to maintain consistency and standardization of the colposcopy procedure regardless of the specific individual performing the procedure (and the individual's skill / expertise level). An exemplary set of such options may include: (1) the ability to use audio prompts; (2) select a specific image capture interval for acetic acid uptake (and a selected acetic acid concentration); (3) whether to include a trial with Lugol's iodine in the procedure; and (4) whether to activate the image viewer system to guide the camera to properly position the anterior cervix.

[0041] The ability to use audio prompts to guide providers through colposcopy procedures (eg, Figure 4 The audio prompts can be turned "off" by controlling the radio button of option 31 for those with a higher skill level. In addition, the audio function can be used to record "verbal" notes spoken by the medical staff while performing the procedure. The included software can be used to convert the verbal notes into written comments using speech-to-text conversion, which form part of the final report of the procedure.

[0042] Image capture interval selection (in Figure 4 30) is associated with the duration of acetic acid uptake on the cervix to be recorded. Figure 4 In the particular configuration of the invention shown, selectable option 30 allows only two selections, the first being to capture a set of images during a 60 second interval and the second being to capture a set of images during a 90 second interval. In either case, video of acetic acid uptake may also be recorded throughout the time interval in which the still images are recorded. It is assumed that if a relatively new or inexperienced medical professional were performing the procedure, she / he would be instructed which option to select based on the protocol established by the organization overseeing the colposcopy procedure, or to perform a patient examination if time permits.

[0043] Another aspect of the acetic acid uptake procedure is the selection of the appropriate acid concentration, and it is well known that different concentrations are better suited to specific situations. In most cases, a 3% or 5% concentration is used, and these concentrations are illustrated as selectable radio buttons with option 32. For those situations where a specialized concentration is being utilized by the medical staff performing the procedure, the possibility of those situations is also shown, and the individual is able to enter the specific concentration being used. Advantageously, all of the information entered is retained as part of the record of the colposcopy procedure, so at a later point in time, anyone else viewing the patient's record will know that this specific acetic acid uptake utilized this "specialized" concentration.

[0044] Also like Figure 4Shown is optional option 34, defined as "Lugol's iodine" (with a yes / no selection). Lugol's iodine is a second test that may be performed by swabbing the cervix with iodine to provide additional visual contrast between abnormal and normal tissue. Whether or not this additional test is necessary is related to a variety of factors, including the availability of Lugol's iodine in the medical setting. Again, assuming that an inexperienced individual is performing a colposcopy procedure, there would be a predefined protocol to instruct the individual as to whether or not to include this second test.

[0045] The final selectable option 36 is defined as "Show Optimal Cervical Viewer" which, when selected by the medical staff, will display a static box in the center of the field of view. The medical staff can then use the camera controls (described in detail below) so that the viewed cervix is ​​within the box. Alternatively, the software controlling the guidance process may include an artificial intelligence (AI) function that automatically locates the cervical borders and controls the camera to optimize its position so that the cervical image is within the guidance box. As shown below in conjunction with Fig.10 As discussed, the use of a cervical guide frame helps ensure that the images captured by the associated cameras during the procedure are in focus and of acceptable quality for later review by all personnel having access to the final report of the procedure.

[0046] While in a relatively basic implementation, the guided colposcopy procedure of the present invention may define a default set of camera settings, embodiments of the present invention may also incorporate the ability to control camera settings, the latter option being a useful tool for more skilled medical personnel.

[0047] Figure 5 is a screen shot of an exemplary set of camera settings 42 that can be controlled by the medical staff at any point during the colposcopy procedure. Included in the camera settings is a "reset" option that can be activated to restore the operation of the camera to "default" settings. As shown in the camera settings 42, the medical staff can adjust the horizontal and vertical positioning of the camera, as well as "zoom in" or "zoom out" as needed. If such introductory camera adjustments are not needed, the medical staff can simply exit the page (see Figure 5 The "x" in the corner of the screenshot 44).

[0048] Now back to Figure 4 Specific description, in this exemplary procedure, the medical staff sets options 30, 31, 32, 34 and 36 to have the following selections: (1) an audio prompt will be played when performing the procedure; (2) a 60 second acetic acid intake interval will be used with the application of 3% acetic acid, and (3) a Lugol iodine test will be included.

[0049] like Figure 4 As shown, the actual surgery begins with the medical staff activating a radio button 38, "Start Surgery". An "Exit" button 39 is also shown. Figure 4 If for some reason or other the individual needs to pause or cancel the colposcopy procedure, the individual can use the exit button 39 to return to the main menu.

[0050] Assuming that the actual guided colposcopy procedure has been initiated, the camera contained in the instrument is activated and the subject's cervix is ​​imaged and displayed on the screen of the device used by the medical professional to guide him / her through the procedure. Figure 6 As shown, an image of the cervix is ​​overlaid with a set of prompts for guiding the medical staff through the colposcopy procedure. In this case, the prompts are displayed as individual milestones along a progression timeline 40. The corresponding milestone for the current step in the procedure is shown in expanded form, and the corresponding milestone includes a label identifying the particular step. After the step is completed, the milestone will be displayed again at its original size and change appearance to indicate that it has been performed. For example, a "hollow circle" can be used to indicate those steps remaining in the procedure, while a "solid circle" can be used to indicate those steps that have been completed. In most cases, the medical staff will be instructed to "tap" or "click" the activated milestone to first initiate the associated step, and a second "tap" or "click" can be used to indicate that the step has been completed (the guided colposcopy procedure will then be moved to display the following step). A separate "next" icon 45 can appear on the screen, and the medical staff can then tap or click the next icon 45 to proceed to the next step in the guided colposcopy procedure instead of activating the milestone a second time. As an alternative to the need to tap or click the display itself, the guided colposcopy procedure of the present invention can also respond to an audio command from the medical staff to proceed to the next milestone.

[0051] Continue to refer Figure 6 In the screenshot of the guided colposcopy process shown in , the first milestone 40-1 is represented as a "pre-saline" step. As a preliminary action, this step serves as an "image quality" check, where the focus and lighting conditions on the cervix are automatically evaluated based on software parameters used to judge image quality. Figure 7 is a screenshot illustrating exemplary results of this image quality check. If the image appears too blurry (e.g. Figure 7), or if the lighting on the display is too dim / too bright, a message 47 will appear on the display prompting the medical staff to adjust the camera focus or lighting accordingly. This pre-operative check of image quality ensures that clear, high-quality images are captured during the procedure. Although not explicitly discussed below, this image quality check can be performed at each milestone to maintain the quality of the captured images in different situations. Once the camera conditions are satisfactory, the medical staff can use any of the methods described above to advance the guided colposcopy procedure.

[0052] Figure 8 The next step of the process is shown in the screenshot of . In particular, milestone 40-2 of the progress timeline 40 is now shown as enlarged, prompting the medical staff to now "apply saline to the cervix". According to the guided colposcopy procedure, milestone 40-1 is now shown as a solid circle, providing the medical staff with visual confirmation that this step has been completed. Once milestone 40-2 is activated, a camera icon 43 will appear on the display, allowing the medical staff to capture one or more images of this step in the guided colposcopy procedure. In fact, if audio prompts are enabled, the staff can be instructed to capture at least one image before proceeding to the next step. Once the image is captured, the medical staff can "tap" or "click" on milestone 40-2 to indicate the completion of the saline application step in the guided colposcopy procedure. It should be understood that the "next" arrow 45 at the bottom of the page can be used to advance the process instead of activating the milestone again, which is a technique that is well known and familiar to individuals trained in computer-based tasks. In fact, the "next" arrow 45 appears on each screen through the guided program, and the "next" arrow 45 can be used to facilitate the various steps of the procedure.

[0053] Reference now Fig. 9 , Fig. 9 , contains a screenshot of the subsequent steps in the guided colposcopy procedure. As shown, the medical staff will now be prompted (shown as milestone 40-3) to swab the cervix with the selected acetic acid solution concentration. Once activated, milestone 40-3 may then change the displayed information to show the instruction "Start Ingestion" (this prompt, like other prompts, may contain different text to guide the procedure; for example, a phrase such as "Ready to Complete" may be displayed). Therefore, once the cervix is ​​swabbed, the medical staff taps / clicks milestone 40-3 again to activate the acetic acid ingestion portion of the procedure.

[0054] Fig.10An exemplary screenshot of the progress of the acetic acid uptake step in a colposcopy procedure is shown. As described above, a guide frame 50 can be used (if selected by the "Viewer" button 36 in the initial selection settings) to overlay the camera image and ensure that the camera remains centered in the "region of interest" (ROI). The medical staff can use the camera movement controls (if available) to ensure the positioning of the ROI within the guide frame 50 (and the guide frame 50 can also be "closed" once the desired centering is achieved). It is contemplated that in alternative embodiments of the software guided process of the present invention, an algorithmic process can be used to control the camera settings so as to automatically perform centering of the ROI within the guide frame 50 (a particularly helpful feature for less experienced medical staff). In some embodiments, the screenshot may include a guide frame radio button 50A, allowing the medical staff to toggle between showing / hiding the guide frame 50. A timer 52 is also displayed during the acetic acid uptake to provide a timestamp for the captured image. Thumbnails 54 of the captured images are also displayed in real time as the uptake proceeds, Fig. 9 A pair of thumbnails 54-1 and 54-2 are shown in FIG. Fig.10 As shown, the ongoing nature of the capture interval may also be indicated by displaying milestone 40-3 with a rotating border.

[0055] Fig.11 is a screen shot of the subsequent steps in the colposcopy procedure upon completion of the acetic acid uptake process. At this point, the medical staff is prompted to locate the squamocolumnar junction (SCJ) (milestone 40-4) and record the digital image. If the medical staff is unable to identify the SCJ in the cervix, she / he is prompted to activate button 60 associated with "not visible", mark this issue by viewing the SCJ, and make this issue part of the patient's record associated with the colposcopy procedure. Various other embodiments and aspects of the present invention are contemplated including the ability to apply artificial intelligence (AI) techniques to various recorded images to assist in finding the location of the SCJ.

[0056] At any point during the procedure after the application of acetic acid, the medical professional may choose to perform a biopsy (at Fig.11 ) As shown in the screenshot of FIG. 6 , radio button 62 is selected for “Perform Biopsy”. Fig.12 As shown in the screenshot of , once activated, the presented image of the cervix is ​​overlaid with a clock 70 (or other suitable location grid). The on-screen editing pen 72 can be used to mark the location of the biopsy on the clock 70, and by activating the camera icon 24 a digital image record of the biopsy location is provided. This information is stored as part of the patient record and can be used as a reference for later access to show where the biopsy was taken and the treatment of the malignant lesion. Once the biopsy has been completed, the medical staff can return to the original location by activating the camera icon 24. Fig.12The "Done" button 76 shown in FIG. 1 returns to the guided colposcopy procedure. In certain embodiments of the present invention, the software used to guide the colposcopy procedure may incorporate a specialized AI to help determine the best location for obtaining a biopsy sample.

[0057] Can be obtained from Figure 4 As will be recalled from the discussion associated with the screenshot of , in selecting the selectable options (30, 31, 32, and 34), the medical personnel in this case indicated that a Lugol iodine test was to be included (i.e., selectable option 34 was marked "yes"). The guided colposcopy procedure of the present invention thus configures the progress timeline 40 to include milestone 40-5 for this step. Fig.13 , showing an enlarged landmark 40-5 with language in the landmark 40-5 prompting the medical staff to apply Lugol's iodine. Fig.14 As shown, once Lugol's iodine has been applied, the medical staff taps button 40-5 to bring up the camera icon 24 on the display. Images can then be captured by the built-in camera (possibly under different lighting conditions - white light, green filter, etc.), which are displayed on the Fig.14 The iodine may be absorbed by normal tissue, thereby further providing a visual distinction between normal tissue and abnormal tissue.

[0058] like Fig.15 As shown, upon completion of milestone 40-5, the medical staff is prompted to tap the "Next" button 45 (or tap / click milestone 40-5 again) to advance to the next screenshot of the guided colposcopy procedure. Since each step in the procedure has now been completed, all milestones along the progress timeline 40 are now displayed as solid circles. If the medical staff wishes to capture some additional images for the patient's record, the camera icon 24 remains activated. In addition, if a biopsy has not yet been performed, the "Perform Biopsy" radio button 62 will continue to appear as an available option.

[0059] exist Fig.15 Also shown in the screenshot of FIG. 8 is an "end procedure" prompt 82. Once activated by the medical staff, a confirmation screen 84 (eg, Fig.16 Assuming the surgery was indeed completed, the guided process then displays a summary of the surgery results, such as Fig.17 The dashboard is in the form of a dashboard illustrated in FIG. The dashboard displays all images captured during the guided colposcopy procedure. All relevant patient identification information is also shown on the dashboard view.

[0060] For experienced medical personnel, the scroll bar and button features shown can be used to call and manipulate various digital images. In some applications, specific software related to image recognition can be used to indicate medically relevant ROIs. These ROIs may include, for example, the degree of whiteness in the cervical image, especially due to acetic acid uptake, and the location of the cervical os (cervical OS).

[0061] For less experienced medical personnel, these tools help detect diagnostically relevant features in the image, guiding these individuals through information pop-ups that display concise instructions on how to use the tools. One aspect of the invention is that any clinician with authenticated access to the stored information (which can be on a secure web server) can view the data. Thus, the surgery may occur on one continent, while the viewing of the captured image is performed on another continent. There is also the ability to add annotations to the file history and write directly on the digital image (e.g., around medically relevant features).

[0062] Fig.18 An exemplary tablet device 90 is illustrated that may be configured according to the principles of the present invention to include the software programs necessary to conduct a guided colposcopy procedure. Fig.18 In a particular view of the present invention, the tablet device 90 is shown to include a touch screen 92 for displaying various screen shots as described above as the guided colposcopy procedure progresses along the defined milestones of the progress timeline 40. An exemplary digital camera peripheral 94 is shown coupled to the tablet device 90 via a communication link 96 (e.g., a wired Universal Serial Bus (USB)). In accordance with the principles of the present invention, the digital camera 94 is controlled by the tablet device 90 to capture various digital images (still images and video images) in the manner described above. Fig.19 An exemplary arrangement of components of a guided colposcopy instrument that may be found in a medical office or clinic setting is illustrated. In particular, Fig.19 A tablet computer 90 and a digital camera peripheral device 94 are shown mounted on a portable instrument stand 100, with both a front view and an isometric rear view included. Fig.19 In this particular arrangement, an additional flat screen display 110 is also included as part of the instrument, which allows other medical personnel to easily view the guided colposcopy procedure in real time. In addition, as described above, the tablet device 90 can communicate with a remotely located computing device (certified device), allowing additional real-time consultation, as well as off-site storage and retrieval of the final report of the guided colposcopy procedure.

[0063] exist Fig.19In a configuration of FIG. 1 , a low energy wireless (e.g., WiFi) connection is used between tablet device 90 and digital camera 94 to control the movement and adjustment of the camera during the procedure to create the desired digital images (still images and video) at the appropriate time points. Likewise, the ability to provide a standardized method of obtaining and recording digital images (including specific lighting and camera settings provided as metadata associated with image capture) allows the system of the present invention to create consistent and standardized data collection for use in making a diagnosis.

[0064] In summary, by recognizing the importance of standardization for consistent image analysis and diagnosis, the integrated software within the colposcopy instrument formed in accordance with the present invention thus prompts the medical staff to capture relevant images in a guided (prompted) sequential process that includes the timing of acetic acid uptake. The entire guided colposcopy procedure may take less than two minutes. This ensures appropriate, relevant, and high-quality images of the cervix for more accurate analysis by the physician and the built-in computing software.

[0065] As mentioned above, there are a range of situations and training for medical personnel in different settings, and the software-guided colposcopy device of the present invention is intended to support less experienced medical personnel during colposcopy. Experienced doctors can also easily use the guided process to train less experienced people. Figure 1-Figure 17 As shown, the tablet / computing device features a unique, easy-to-use user interface that guides the medical staff through a series of clear on-screen prompts to capture key images during the examination. The procedure is automatic once it begins and does not require an individual to decide when to capture images. Relevant images are displayed to the medical staff after the procedure is completed. Relevant images include images taken before, during, and after acetic acid application, video of tissue uptake of acetic acid (if recorded), images of the SCJ, and images after application of Lugol's iodine.

[0066] Standardization, consistency, and collection of all relevant images can reduce subjectivity and variability in diagnostic assessments that would otherwise exist without a guided process and a series of image capture prompts; this is particularly important for colposcopy and cervical precancer screening, where a battery of images is expected to be captured for quality assurance.

[0067] Although various embodiments of the present invention have been described above, it should be understood that they are presented by way of example only, rather than limiting the present invention. Therefore, the breadth and scope of the present invention are not considered to be limited by any of the above described embodiments, but should only be limited by the appended claims.

Claims

1. A method for collecting data during a guided colposcopy procedure using a combination of a digital camera and a computer-controlled colposcopy instrument including a display screen, the method include: activating the computer-controlled colposcopy instrument to display on a display screen a plurality of selectable options associated with a defined set of steps in the guided colposcopy procedure, the defined set of steps comprising at least the following sequential steps: (1) performing a saline swab of the cervix, and (2) performing an acetic acid ingestion; selecting a value for each of the plurality of selectable options presented on the display screen; commanding the computer-controlled colposcopy instrument to start the digital camera to present a digital image of a cervical region of interest (ROI) on the display screen; presenting a set of timeline milestones as an overlay on the digital image, each milestone associated with a single step of the defined set of steps in the guided colposcopy procedure; Prompts providers through each individual step of the guided colposcopy procedure, changing the visual presentation of each milestone as the step is completed; collecting digital image data of the cervical ROI according to the prompt of the computer-controlled colposcopy instrument; as well as A final report of the colposcopy procedure is created in a tangible form, the final report including digital image data of the cervical ROI captured during the procedure, the final report being used by medical personnel responsible for determining a diagnosis.

2. The method according to claim 1, in, The plurality of selectable options includes selection from a list of predefined time intervals for collecting digital image data during the acetic acid uptake step.

3. The method according to claim 2, in, The plurality of selectable options also includes an acetic acid concentration selection selected from a predefined acetic acid list for the acetic acid uptake step.

4. The method according to claim 3, in, The acetic acid concentration selection includes a fill-in option manually entered by medical personnel.

5. The method according to claim 2, in, The step of collecting digital image data includes automatically capturing digital image data of acetic acid uptake during selected predefined time intervals, thereby allowing the impact rate of acetic acid uptake on the final diagnostic recommendation to be evaluated.

6. The method according to claim 2, in, The plurality of selectable options also includes a choice of whether to include a Lugol's iodine step.

7. The method according to claim 2, in, The plurality of selectable options also includes a selection to allow or not allow audio prompts during the guided colposcopy procedure.

8. The method according to claim 7, in, The audio prompts also include the capability for voice recognition for the medical staff.

9. The method according to claim 8, in, Voice recognition is used to advance the guided colposcopy procedure from a first milestone to the next milestone.

10. The method according to claim 8, in, Speech recognition is used to record the surgical notes spoken by the medical staff so that the surgical notes can be included in the generated final report.

11. The method according to claim 2, in, The plurality of selectable options also include a selection of whether to overlay a reference frame onto the cervical ROI presented on the display screen.

12. The method according to claim 11, in, When the reference frame is selected to be included, the method further comprises the following steps: The computer-controlled colposcopy instrument is commanded to display a set of camera settings for use by the medical personnel to adjust focus and illumination of the cervix in the digital image and to center the cervix within a reference frame of the display screen.

13. The method according to claim 11, in, When the reference frame is selected to be included, the method further comprises the following steps: The digital image processing capabilities of the computer-controlled colposcopy instrument are utilized to automatically inspect the cervix and adjust the camera settings to position the cervix within the reference frame to improve focus and illumination.

14. The method according to claim 1, in, The method further comprises presenting camera controls on the display screen; and In response to the medical personnel's use of the presented camera controls, the focus / illumination of the displayed cervical ROI is adjusted.

15. The method according to claim 1, in, The method further comprises presenting camera controls on the display screen; and Utilizing the digital image processing capabilities of the computer-controlled colposcopy instrument, the focus / illumination of the displayed cervical ROI is automatically adjusted to optimize the presentation of the digital image.

16. The method according to claim 1, in, The method further comprises A selectable option is presented on the display screen after the acetic acid uptake step to perform a biopsy prior to generating the final report.

17. The method according to claim 16, in, The biopsy procedure includes the following steps of instructing the computer-controlled colposcopy instrument to perform the following steps: (1) displaying a reference grid on an image of the cervical ROI; and (2) presenting a marking tool controllable by said medical personnel to indicate a biopsy location on said reference grid; as well as Information associated with the location of the biopsy is stored in the final report that is created.

18. The method according to claim 1, in, The step of creating the final report includes activating selected captured images for further review and annotating relevant information for inclusion in the final report.

19. The method according to claim 1, in, The method further comprises the following steps: The final report created is stored in an electronic file associated with the patient.

20. The method according to claim 19, in, The method further comprises the following steps: The electronic file is maintained in a system accessible by certified medical personnel.

21. The method according to claim 1, in, The method further comprises the following steps: Electronically stored patient history information is retrieved for review during the guided colposcopy procedure.

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