SYSTEMS AND METHODS FOR ENHANCED AUTOMATED ENDOSCOPY PROCEDURE WORKFLOW
20230210348 · 2023-07-06
Assignee
Inventors
- Andrew NINH (Fountain Valley, CA, US)
- Peter CROSBY (San Juan Capistrano, CA, US)
- William E. KARNES (Irvine, CA, US)
- Efren RAEL (Belmont, CA, US)
- John CIFARELLI (Oyster Bay, NY, US)
Cpc classification
A61B1/31
HUMAN NECESSITIES
A61B1/04
HUMAN NECESSITIES
G16H50/20
PHYSICS
G16H20/40
PHYSICS
G16H10/60
PHYSICS
G16H50/70
PHYSICS
G16H15/00
PHYSICS
A61B1/0005
HUMAN NECESSITIES
H04N5/272
ELECTRICITY
G16H70/40
PHYSICS
International classification
A61B1/00
HUMAN NECESSITIES
Abstract
Systems and methods are provided for delivering consistent high quality, cost efficient results in fixed or mobile endoscopy facilities, without requiring the continuous real-time involvement of a fellowship trained gastroenterologist, by integrating patient specific information into decision support systems and AI/machine learning systems employed during the planning and examination phases of the endoscopy procedure.
Claims
1. A system for enhancing detection of tissue abnormalities during an endoscopic procedure, the system comprising: an endoscopy system that outputs a video stream; a monitor; and a processor implementing a patient electronic intake module and an artificial intelligence module, wherein, responsive to data input by a patient, the patient electronic intake module transmits patient specific data to the artificial intelligence module; and wherein the artificial intelligence module is configured to preferentially search for features in the video stream indicative of tissue abnormalities corresponding to the patient specific data, the artificial intelligence module generating an overlay for display on the monitor identifying features in the video stream indicative of a presence of tissue abnormalities.
2. The system of claim 1, wherein the patient specific data comprises patient identification information.
3. The system of claim 1, wherein the patient specific data comprises patient medical history information.
4. The system of claim 3, further comprising a database, wherein the patient electronic intake module initiates retrieval of patient medical history information from the database.
5. The system of claim 1, wherein the patient specific data comprises family medical history information for the patient.
6. The system of claim 5, further comprising a database, wherein the patient electronic intake module initiates retrieval of patient family medical history information from the database.
7. The system of claim 1, wherein the system further comprises a database and a storage module for recording to the database procedure information about the video stream and overlay generated during the endoscopic procedure.
8. The system of claim 7, further comprising a report generation module, wherein the report generation module selects from the database a subset of the procedure information and formats the subset into a report.
9. The system of claim 1, wherein the patient electronic intake module is configured to present a series of questions to the patient to determine compliance with bowel cleansing guidelines.
10. The system of claim 1, wherein the patient electronic intake module is configured to present an informative video describing the endoscopic procedure and, responsive to patient inputs, present options for sedation or anesthesia.
11. A method for enhancing detection of tissue abnormalities during an endoscopic procedure, the method implemented by a processor executing a patient electronic intake module and an artificial intelligence module for use with an endoscopy system that outputs a video stream and a monitor, the method comprising: by the patient electronic intake module, querying the patient to input data; responsive to data input by a patient to the patient electronic intake module, transmitting patient specific data to the artificial intelligence module; based on the patient specific data, configuring the artificial intelligence module to preferentially search for features in the video stream indicative of tissue abnormalities that correspond to the patient specific data; and generating by the artificial intelligence module an overlay for display on the monitor identifying features in the video stream indicative of a presence of tissue abnormalities.
12. The method of claim 11, wherein querying the patient to input data comprises querying the patient to input patient identification information.
13. The method of claim 11, wherein querying the patient to input data comprises querying the patient to input patient medical history information.
14. The method of claim 11, further comprising retrieving patient medical history information from a database responsive to the data input by the patient.
15. The method of claim 11, wherein querying the patient to input data comprises querying the patient to input patient family medical history information.
16. The method of claim 11, further comprising retrieving patient family medical history information from a database responsive to the data input by the patient.
17. The method of claim 11, further comprising recording to a database procedure information about the video stream and overlay generated during the endoscopic procedure.
18. The method of claim 17, further comprising selecting from the database a subset of the procedure information and formatting the subset into a report.
19. The method of claim 11, further comprising, by the patient electronic intake module, presenting a series of questions to the patient to determine compliance with bowel cleansing guidelines.
20. The method of claim 11, further comprising, by the patient electronic intake module, presenting an informative video describing the endoscopic procedure and, responsive to patient inputs, presenting options for sedation or anesthesia.
21. The method of claim 11, wherein machine learning generated algorithms are trained using cross-validation.
Description
BRIEF DESCRIPTION OF THE DRAWINGS
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[0039]
[0040]
[0041]
[0042]
[0043]
[0044]
DETAILED DESCRIPTION OF THE INVENTION
[0045] The present invention provides systems and methods for delivering consistent high quality, cost efficient results in fixed or mobile endoscopy facilities without requiring the continuous real-time involvement of a fellowship-trained gastroenterologist. More particularly, the inventive systems and methods improve the workflow for endoscopic procedures by integrating patient specific information into decision support systems and AI/machine learning systems employed during the planning and examination phases of the endoscopy procedure, thereby improve the consistency of detection of abnormalities, and enhancing patient care. In the following specification, reference is made in detail to specific embodiments of the invention suitable for use in endoscopic procedures such as colonoscopy. It should be understood, however, that the benefits and advantages of the present invention are equally available for other endoscopic procedures such as esophageal and airway examination.
[0046] In accordance with one aspect of the invention, system and methods are provided wherein an automated patient questionnaire is used to collect patient information during patient admission/intake. That information in turn is employed by an artificial intelligence system to aid in decision support and detection of adenomas. The addition of the AI system ensures consistent high-quality results, independent of the qualifications and experience of the person performing the endoscopy.
[0047] In accordance with another aspect of the invention, automation is provided to facilitate otherwise laborious tasks, such as: patient intake and analysis; determining whether the patient complied with bowel cleansing guidelines prior to the appointment; assessing the patient's likelihood of needing an intervention based on demographics, personal and family history, and indication of the procedure; real-time endoscope maneuverability guidance; and automated post-operative report generation and billing/coding. Automating these normally labor-intensive steps is expected to streamline the endoscopy process, improve facility efficiency, and reduce overhead and number of staff required to operate the endoscopy lab. When implemented together with tuning of the decision support system and detection system based on patient specific data, the inventive system and methods will enable endoscopy procedures to be more accessible in geographies with fewer resources and minimal access to endoscopy expertise, while maintaining a high-quality service and detection capabilities.
[0048] In accordance with yet another aspect of the invention, automated collection and analysis of data from multiple patient procedures is expected continually to improve the AI decision support system and to monitor performance.
[0049] Referring to
[0050] During the colonoscopy procedure, colonoscope 110 is advanced to the cecum, the region near the top of the colon at the junction with the small intestine, and then withdrawn slowly. As is conventional in such examinations, the endoscopist may apply rinse and suction to the mucosal surface during advancement to remove residual fecal matter or opaque liquid to cleanse the organ and enhance visibility. Once this process is completed and the colonoscope advanced to the cecum, colonoscope 110 is withdrawn while the endoscopist closely inspects the images of the colon surface (the mucosa). Nurse 104 and surgical technician 106 may assist during the procedure by repositioning the patient if needed, by applying pressure to the patient, monitoring patient vital signs, applying and monitoring anesthesia and sedation, and assisting with interventions. In some settings, the endoscopy procedure may be performed by the endoscopist 108 and nurse 104, without technician 106, or some other combination of medical professionals.
[0051] Real-time overlay on the endoscope video image displayed on monitor 102 (illustratively includes bounding box 103a) informs the endoscopist of color or textural changes in the mucosal surface that require closer examination. Additional textual information 103b displayed adjacent to the video image may assist endoscopist 108 to maneuver the colonoscope through spastic episodes or difficult flexures in the anatomy with minimal assistance from nurse 104 or technician 106.
[0052] Monitors 102a and 102b may be general purpose or specialized video monitors that accept any standard or proprietary video signal, including but not limited to HDMI, SDI, 3G-SDI, 6G-SDI, DVI, and DisplayPort, and optionally may be capable of additional functionality, including any of picture-in-picture (PIP), video signal loop-through, audio input, split screen, and toggling between multiple inputs.
[0053] Referring now to
[0054]
[0055] An endoscopy center usually is associated with a pathology laboratory that receives samples for analysis by a pathologist. The pathology laboratory may be part of an endoscopy facility or may be located elsewhere. In accordance with one aspect of the present invention, results of any pathology analysis conducted on biopsied tissues preferably are linked with the patient's medical record, so that they can be retrieved for review and comparison purposes in connection with subsequent endoscopic examinations.
[0056] Referring now to
[0057] As will be understood by a person familiar with mobile surgical suites, mobile endoscopy center 400 may be located in a semi-trailer truck or single or multiple story prefabricated mobile structure. It will also be appreciated that the facilities provided in mobile endoscopy center 400 are exemplary, and that some facilities omitted and others added—for example, pathology laboratory 412 may be omitted and pathology samples may be transported elsewhere for analysis.
[0058]
[0059] A computerized algorithm inputs and processes the patient data, at step 506, to cross-reference historic patient records, and to search and retrieve data from external databases such as from Health Information Exchanges across multiple health information systems (HIS). The endoscopy staff then is informed that the patient's records are available and that the patient is ready in the waiting room. By inputting information such as demographic, personal and family history, and an indication for the procedure, the endoscopy staff can prepare the endoscopy unit and prepare equipment to be used during the examination. The patient questionnaire also accepts data about whether the patient has followed the colonoscopy cleaning preparation guidelines the night before, at step 508. If the patient indicates that such cleaning preparation guidelines were not observed, the patient may be immediately discharged, at step 522, and no procedure is performed.
[0060] Because in most instances the patient would have completed the necessary cleaning preparation, the patient next is alerted, at step 510, to enter the pre-/post-operating recovery area and to change into a surgical gown. At the time of the patient's procedure, the patient is wheeled on a gurney into the endoscopy lab by a nurse, at step 512. Before the patient is optionally sedated and the procedure begins, the surgical staff goes through a surgical safety checklist, at step 514. Next, the endoscopy procedure is performed, at step 516, during which a plurality of sensors monitor and record patient signals, such as audio, optical, endoscopy video, and vital signs signals. In accordance with one aspect of this invention, the sensor signals may be processed in real-time to provide decision support that aids in the safe and efficient maneuvering of the endoscope. Preferably, the real-time decision support system includes an AI (machine learning) system. Upon the completion of the procedure, the patient is wheeled back to the recovery bay, at step 518.
[0061] Data collected during the procedure may be automatically analyzed using a computer system concurrently, and post-procedure, to generate a comprehensive endoscopy report that is provided to the patient and referring physician for recordkeeping, at step 520. Preferably, the computer system that generates the report also accepts information from the decision support system, for example time of insertion, time of reaching the cecum, and withdrawal time. The report also may be used by the facility and endoscopist to bill for the procedure and may be integrated with a larger HIS or electronic medical record (EMR) or endoscopy report writer for archiving and billing. The patient then is discharged by the supervising endoscopist, at step 522.
[0062] Referring now to
[0063] Referring again to
[0064] Referring to
[0065] At step 588 of
[0066] At step 588 of
[0067] In one embodiment e.g.: of a mobile facility, an anesthesiologist may not be available. Prior to the procedure, the patient is informed of the choices available excluding anesthesia. If a patient requires anesthesia, then the patient is not scheduled for the procedure and may be referred to an alternative site or time at which an anesthesiologist is available. This step minimizes the risk that a patient may present for the procedure which cannot be performed due to the absence of an anesthesiologist.
[0068] At step 592, when the patient has completed the intake questionnaire, the patient is directed to the pre-procedure waiting room, for example, via directional arrows on the wall or floor of the facility, or by verbal commands. Once the patient arrives the pre-procedure waiting room, he or she may be directed to change into a surgical gown, take any oral sedative dispensed responsive to the patient's elections, and to await further direction from the staff.
[0069] Referring now to
[0070] Still referring to
[0071] At step 604, the decision support system may load profiles for automated abnormality detection, and that may be used to guide the endoscopist's movement of the colonoscope, based on the personal and family medical history for the patient. For example, if the patient or a close blood relative previously has been observed to present with polyps or particular types of adenomas, the system may set up to analyze the video stream generated by the colonoscope to detect such abnormalities corresponding to the patient specific medical history information provided to the decision support system. As a further example, if certain tissue abnormalities were detected during a prior examination, the AI algorithms may be adjusted to bias or preferentially look for recurrence of such abnormalities in the video stream generated during the current examination. In addition, the overlay of information on monitor 102a (see
[0072] At step 606, the endoscopist is alerted that the patient has been prepared by the staff, e.g., sedated and connected to vital signs monitoring equipment and is ready for the examination. At step 608, the patient is moved to the surgical suite on a gurney. Referring now also to
[0073] Once the procedure is completed, at step 620, the decision support system generates updates to the exam report that was initiated at step 558 to include a summary of voice comments, flagged annotations and corresponding images captured from the video stream. The video record is made available to the endoscopist for review and approval before it is sent to the referring physician. The entire video log and report then are stored in the health information system database. At step 624, the patient is wheeled on the gurney to the recovery room, and once the anesthesia and/or sedation wears off, is permitted to dress and exist the facility. Selected information from the exam report generated at the conclusion of the procedure, for example, the length of the procedure and number of biopsies, may be used to populate the billing record generated at step 556.
[0074] In
[0075] Remote computing resources, e.g. in cloud 708 may continually or episodically examine the image data and patient notes and may use that data to update the machine learning system embodied in local computer 706. In this manner, the performance of the AI assisted endoscopy procedure is continually and automatically improved over time.
[0076] Additionally, remote computing resources in cloud 708 may be programmed to monitor the performance of individual endoscopists, for example, by reviewing ADR over time and comparing results from pathology testing with the endoscopists' assignment of pathology status during the procedure. In this manner, the quality metrics of the endoscopy system are recorded, and may be reported as required by law or regulation to health care authorities. Such quality metrics also may be used to report back to each endoscopist on his or her performance, and to provide guidance on potential improvement.
[0077] Various general-purpose systems may be used to implement the systems and methods in accordance with the teachings herein. Alternatively, the system made be implemented with more specialized apparatus. Implementation of the inventive features is not limited to any particular endoscope manufacturer, ancillary endoscopy equipment, programming languages, or computer systems. It will be appreciated that a variety of commercially available endoscopy equipment, networking methods, and programming languages may be used to implement the inventive systems and methods.
[0078] The system and methods described herein may be provided as a computer program product, or software, that may include a machine-readable medium having stored thereon instructions, which may be used to program a computer system (or other electronic devices) to perform a process according to the present disclosure. A machine-readable medium includes any medium for storing information in a form readable by a machine (e.g., a computer). For example, a machine-readable (e.g., computer-readable) medium includes a machine readable storage medium such as a read only memory (“ROM”), random access memory (“RAM”), magnetic disk storage media, optical storage media, flash memory devices, etc.
[0079] It will also be appreciated by one skilled in the art than any data or program storage could be cloud storage, accessible via internet connection such as wireless (Wi-Fi), fixed line (Ethernet) or via the data service on a mobile network.
[0080] In addition, it should be understood that steps of the exemplary methods set forth herein may be performed in different orders than presented in this specification. Furthermore, some steps of the exemplary methods may be performed in parallel rather than sequentially. The steps of the exemplary methods may be performed in any suitable location including a hospital, ambulatory surgery center, outpatient clinic, doctor's office, or a mobile facility.
[0081] In the foregoing disclosure, embodiments have been described with reference to specific example implementations thereof. It will be evident that various modifications may be made thereto without departing from the broader spirit and scope of the disclosure as set forth in the following claims.