WO2020096893A1 - Identifiers in medical device lumen - Google Patents

Identifiers in medical device lumen Download PDF

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Publication number
WO2020096893A1
WO2020096893A1 PCT/US2019/059362 US2019059362W WO2020096893A1 WO 2020096893 A1 WO2020096893 A1 WO 2020096893A1 US 2019059362 W US2019059362 W US 2019059362W WO 2020096893 A1 WO2020096893 A1 WO 2020096893A1
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WO
WIPO (PCT)
Prior art keywords
lumen
endoscope
layer
interior surface
damage
Prior art date
Application number
PCT/US2019/059362
Other languages
French (fr)
Inventor
Nicholas G. BROMILEY
Michael Petersen
Joseph G. JOHNNIE
Brett RISKE
Mer Win CHEONG
Original Assignee
Medivators Inc.
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 Medivators Inc. filed Critical Medivators Inc.
Publication of WO2020096893A1 publication Critical patent/WO2020096893A1/en

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B1/00Instruments 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
    • A61B1/00002Operational features of endoscopes
    • A61B1/00057Operational features of endoscopes provided with means for testing or calibration
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B1/00Instruments 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
    • A61B1/12Instruments 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 with cooling or rinsing arrangements
    • A61B1/121Instruments 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 with cooling or rinsing arrangements provided with means for cleaning post-use
    • A61B1/122Instruments 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 with cooling or rinsing arrangements provided with means for cleaning post-use using cleaning tools, e.g. brushes
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/90Identification means for patients or instruments, e.g. tags
    • A61B90/94Identification means for patients or instruments, e.g. tags coded with symbols, e.g. text
    • A61B90/96Identification means for patients or instruments, e.g. tags coded with symbols, e.g. text using barcodes
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/90Identification means for patients or instruments, e.g. tags
    • A61B90/98Identification means for patients or instruments, e.g. tags using electromagnetic means, e.g. transponders
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N21/00Investigating or analysing materials by the use of optical means, i.e. using sub-millimetre waves, infrared, visible or ultraviolet light
    • G01N21/84Systems specially adapted for particular applications
    • G01N21/88Investigating the presence of flaws or contamination
    • G01N21/94Investigating contamination, e.g. dust
    • GPHYSICS
    • G02OPTICS
    • G02BOPTICAL ELEMENTS, SYSTEMS OR APPARATUS
    • G02B23/00Telescopes, e.g. binoculars; Periscopes; Instruments for viewing the inside of hollow bodies; Viewfinders; Optical aiming or sighting devices
    • G02B23/24Instruments or systems for viewing the inside of hollow bodies, e.g. fibrescopes
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B1/00Instruments 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
    • A61B1/012Instruments 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 characterised by internal passages or accessories therefor
    • A61B1/0125Endoscope within endoscope
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/70Cleaning devices specially adapted for surgical instruments
    • A61B2090/702Devices for testing the cleaning process, e.g. test soils
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N21/00Investigating or analysing materials by the use of optical means, i.e. using sub-millimetre waves, infrared, visible or ultraviolet light
    • G01N21/84Systems specially adapted for particular applications
    • G01N21/88Investigating the presence of flaws or contamination
    • G01N21/94Investigating contamination, e.g. dust
    • G01N2021/945Liquid or solid deposits of macroscopic size on surfaces, e.g. drops, films, or clustered contaminants
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N21/00Investigating or analysing materials by the use of optical means, i.e. using sub-millimetre waves, infrared, visible or ultraviolet light
    • G01N21/62Systems in which the material investigated is excited whereby it emits light or causes a change in wavelength of the incident light
    • G01N21/63Systems in which the material investigated is excited whereby it emits light or causes a change in wavelength of the incident light optically excited
    • G01N21/64Fluorescence; Phosphorescence
    • G01N21/6486Measuring fluorescence of biological material, e.g. DNA, RNA, cells

Definitions

  • Embodiments pertain to the cleaning and reprocessing of reusable medical equipment. More particularly, this disclosure relates to, but not by way of limitation, inspection of endoscopes.
  • Endoscopes are optical instruments that are insertable into patient cavities for observation of body systems such as joints, the digestive tract, kidneys, and bladders.
  • endoscopes provide illumination to enhance optical performance.
  • Endoscopes can be used for diagnostic purposes (e.g., observe tissue; take tissue samples), or therapeutic/treatment purposes (e.g., to remove polyps, remove cancer, introduce drugs, etc.) as the endoscope provides both a visual and operative pathway. After use for inspection or a surgical procedure, an endoscope can be processed for reuse with another patient or procedure.
  • a number of protocols and assisting equipment for cleaning, disinfection, and inspection are used by current medical practices to reprocess endoscopes and prepare them for subsequent procedures.
  • various machines and devices such as automated endoscope reprocessors are used to perform deep cleaning of an endoscope, through the application of disinfecting cleaning solutions.
  • High-level disinfection or sterilization processes are typically performed after manual cleaning to remove remaining amounts of soils and biological materials.
  • an endoscope is not considered as ready for high-level disinfection or sterilization until it has been inspected and verified to function correctly, without any damage or leaking parts. If the endoscope includes damaged surfaces, leaks, broken controls, or the like, the endoscope may not be fully exposed to deep cleaning by the disinfecting chemicals, and the opportunity for spreading contamination significantly increases.
  • FIG. 1 illustrates an overview of devices and systems involved in stages of endoscope use and reprocessing, in accordance with at least one example of the present disclosure.
  • FIG. 2 illustrates a schematic cross-section illustration of an endoscope, operated, in accordance with at least one example of the present disclosure.
  • FIG. 3 illustrates data flows provided with a cleaning workflow and tracking system, during respective stages of endoscope use and processing, in accordance with at least one example of the present disclosure.
  • FIG. 4 illustrates a block diagram of system components used to interface among imaging, tracking, in accordance with at least one example of the present disclosure.
  • FIG. 5 illustrates a perspective view of a portion of a borescope within a lumen of an endoscope, in accordance with at least one example of the present disclosure.
  • FIG. 6A illustrates a focused perspective view of a portion of a borescope within a lumen of an endoscope, in accordance with at least one example of the present disclosure.
  • FIG. 6B illustrates a further focused perspective view portion of a portion of a borescope within a lumen of an endoscope, in accordance with at least one example of the present disclosure.
  • FIG. 7 A illustrates a focused side view of an internal portion of a lumen of an endoscope, in accordance with at least one example of the present disclosure.
  • FIG. 7B illustrates a focused side view of an internal portion of a lumen of an endoscope, in accordance with at least one example of the present disclosure.
  • FIG. 7C illustrates a focused side view of an internal portion of a lumen of an endoscope, in accordance with at least one example of the present disclosure.
  • FIG. 7D illustrates a focused side view of an internal portion of a lumen of an endoscope, in accordance with at least one example of the present disclosure.
  • FIG. 8A illustrates a cross-section view of a lumen of an endoscope, in accordance with at least one example of the present disclosure.
  • FIG. 8B illustrates a focused cross-section view of a lumen of an endoscope, in accordance with at least one example of the present disclosure.
  • FIG. 9 illustrates a block diagram of architecture for an example computing system used, according to at least one example of the present disclosure.
  • FIG. 10 illustrates a schematic view of a method, in accordance with at least one example of the present disclosure.
  • FIG. 11 illustrates a schematic view of a method, in accordance with at least one example of the present disclosure.
  • FIG. 12 illustrates a schematic view of a method, in accordance with at least one example of the present disclosure.
  • a major problem in reprocessing of endoscopes is the cleaning of the lumens in the endoscope, specifically the suction and biopsy channel. These lumens can easily become damaged or covered in biofilm. Relatively recent industry standards recommend that endoscope channels be visually inspected to determine if they are damaged or they contain biofilm or other organic material. Such inspection can be difficult and may require special borescopes that can look down the small channels. Even with the use of a borescope, it can be difficult to determine if a scope channel is damaged.
  • This disclosure addresses these issues by creating a suction / biopsy channel that contains a predefined pattern on the internal surface of the lumen. Such a pattern can be detected by a visualization system.
  • a pattern, indicator, or identifier can be applied to a specific depth of the lumen, enabling automated inspection to determine if the lumen had been damaged, to measure the depth of the damage, and to detect if a biofilm is or was coating a portion of the lumen.
  • FIG. 1 illustrates an overview of devices and systems involved in example stages of endoscope use and reprocessing.
  • a series of stages are sequentially depicted for use and handling of the endoscope, transitioning from a procedure use stage 110, to manual reprocessing stage 120, to an automated reprocessing stage 140, to a storage stage 150.
  • the stages 110, 120, 140, 150 as depicted and described provide a simplified illustration of typical scenarios in the use, handling, and reprocessing for reusable endoscopes.
  • many additional steps and the use of additional devices and procedures may be involved in the respective stages.
  • the procedure use stage 110 depicts a human user 112 (e.g., technician, nurse, physician, etc.) who handles an endoscope.
  • the endoscope 116A is obtained in a high level disinfected (HFD) or sterile/clean state. This disinfected/clean state typically results from reprocessing and storage of the endoscope 116A, although the state may also be provided from a disinfected repair or factory-provided state (not shown).
  • the endoscope 116A may be used for various endoscopic procedures (e.g., colonoscopy, upper endoscopy, etc.) on a subject human patient, for any number of diagnostic or therapeutic purposes.
  • the endoscope 116A is exposed to biological material from the subject patient or the surrounding environment.
  • the endoscope 116A exists in a contaminated state.
  • the disinfected or contamination state of the endoscope 116A may be tracked by a tracking system for purposes of monitoring, auditing, and other aspects of workflow control.
  • An interface 114 to the tracking system is shown, which receives an identifier of the endoscope 116A and provides a graphical status as output.
  • the tracking system may be used in the procedure use stage 110 (and the other stages 120, 140, 150) to identify the use of the endoscope 116A to be associated with a particular imaging procedure, patient, procedure equipment, procedure room, preparation or cleaning protocol, or other equipment or activities. This identifying information may enable the tracking system to track the contamination or disinfected state of the endoscope, and to identify and prevent exposure of contamination or infectious agents to patients or handling personnel from damaged endoscopes or improper cleaning procedures.
  • the endoscope transitions to handling in a manual reprocessing stage 120.
  • the manual reprocessing stage 120 specifically depicts the use of manual cleaning activities being performed by a technician 122, to clean the endoscope 116B.
  • the type of manual cleaning activities may include use of disassembly and removal of components, applying brushes to clear channels, wiping to remove visible liquids and solids, and other human-performed cleaning actions. Some of the manual cleaning activities may occur according to a regulated sequence or manufacturer-specified instructions.
  • the manual reprocessing stage 120 also depicts the use of a flushing aid device 128 and a borescope 126 to conduct additional aspects of cleaning and inspection.
  • the flushing aid device 128 serves to perform an initial chemical flush of the internal channels of the endoscope 116B (e.g., water, air, or suction channels) with cleaning agents.
  • the flushing aid device 128 may also enable the performance of leak testing, to verify whether components or structures of the endoscope leak fluid (e.g., leak water or air).
  • the flushing or leak test actions performed by the flushing aid device 128 are manually performed by the syringing of chemicals or air into the endoscope channels. The results of the leak testing and the flushing may be tracked or managed as part of a device tracking or cleaning workflow.
  • the borescope 126 is used as part of an inspection process, such as to inspect an interior lumen of a channel in the endoscope 116B. This may include the inspection of a channel of the endoscope 116B used for biopsy and instrument insertion.
  • the borescope 126 be inserted and advanced by a human or a machine within one or more lumens of the endoscope 116B to perform the inspection process. This inspection process may occur before or after the performance of the leak test, flushing, or other cleaning or testing activities in the manual reprocessing stage 120.
  • the borescope 126 may produce image data 132 (e.g., one or more images, such as a video) that provides a detailed, high-resolution view of the status of a channel of the endoscope 116B.
  • the image data 132 may be provided to a computing system 130 for processing and analysis.
  • the borescope 126 may be operated as part of a borescope inspection system, which provides controlled or mechanicalized advancement and movement of the borescope 126 within an inspection procedure.
  • the results of the borescope inspection procedure may be tracked or managed as part of a device tracking or cleaning workflow, including with the aforementioned tracking system.
  • the computing system 130 is provided by a visual inspection processing system that uses a trained artificial intelligence (e.g., machine learning) model to analyze image data 132 and identify a state of the endoscope channel.
  • a trained artificial intelligence e.g., machine learning
  • the state of the endoscope channel may include, no detected abnormalities (e.g., an integrity state), or a detected presence of biological material or a detected presence of channel damage (e.g., a compromised state).
  • no detected abnormalities e.g., an integrity state
  • a detected presence of biological material e.g., a compromised state
  • a detected presence of channel damage e.g., a compromised state
  • the endoscope is handled in an automated reprocessing stage 140.
  • This may include the use of an automatic endoscope reprocessor (AER) 142, or other machines which provide a high-level disinfection and sterilization of the endoscope.
  • the AER 142 may perform disinfection for a period of time (e.g., for a period of minutes) to expose the interior channels and exterior surfaces of the endoscope to deep chemical cleaning and disinfectant solutions.
  • the AER 142 may also perform rinsing procedures with clean water to remove chemical residues.
  • the endoscope transitions to handling in a storage stage 150.
  • This may include the storage of the endoscope in a sterile storage unit 152. In some examples, this stage may also include the temporary storage of the endoscope in a drying unit. Finally, retrieval of the endoscope from the storage stage 150 for use in a procedure results in
  • the overall cleaning workflow provided for an endoscope within the various reprocessing stages 120 and 140 may vary according to the specific type of device, device specific requirements and components, regulations, and the types of cleaning chemicals and devices applied. However, the overall device use and cleaning workflow, relative to stages of contamination, may be generally summarized in stages 110, 120, 140, 150, as involving the following steps:
  • Damage inspection e.g., conducted in manual reprocessing stage 140 with a borescope inspection system.
  • Microbes and in particular biofilm may resist cleaning if lodged in damaged or irregular portions of the endoscope.
  • a procedure of damage inspection can be used to identify surface irregularities, scratches and fissures, or other defects or abnormal states (e.g., a compromised state) within the interior channels, exterior surfaces, or components of the endoscope.
  • This damage inspection may also be accompanied by the detection of biological materials (such as biofilms) which remain after manual washing.
  • Such damage inspection may be performed with use of a borescope inspection system, visual inspection system, and other mechanisms discussed herein.
  • a risk of introducing new contamination may also be present based on the method and environment of transport and handling.
  • Further aspects which may affect contamination may involve the management of valves and tubing used with a patient. For instance, the use of reusable valves, tubing, or water bottles in the procedure may re-introduce contamination to the endoscope. Accordingly, the disinfected state of a processed endoscope can only be provided in connection with the use of other disinfected equipment and proper handling in a clean environment.
  • FIG. 2 is a schematic cross-section illustration of an endoscope 200, operable according to various examples.
  • the endoscope 200 as depicted includes portions that are generally divided into a control section 202, an insertion tube 204, a universal cord 206, and a light guide section 208.
  • a number of imaging, light, and stiffness components and related wires and controls used in endoscopes are not depicted for simplicity. Rather, FIG. 2 is intended to provide a simplified illustration of the channels important for endoscope cleaning workflows. It will be understood that the presently discussed endoscope cleaning workflows will be applicable to other form factors and designs of endoscopes.
  • the inventive aspects discussed herein can also be utilized for inspection operations on other instruments that include lumens that can become contaminated or damaged during use.
  • the control section 202 hosts a number of controls used to actuate the positioning, shape, and behavior of the endoscope 200. For instance, if the insertion tube 204 is flexible, the control section 202 may enable the operator to flex the insertion tube 204 based on patient anatomy and the endoscopic procedure.
  • the control section 202 also includes a suction valve 210 allowing the operator to controllably apply suction at a nozzle 220 via a suction channel 230.
  • the control section 202 also includes an air/water valve 212 which allows the distribution of air and/or water from an air channel 232 (provided from an air pipe source 218) or a water channel 228 (provided from a water source connected to a water source connector 224) to the nozzle 220.
  • the depicted design of the endoscope 200 also includes a water jet connector 222 via a water-jet channel 226, to provide additional distribution of water separate from the air channel 232.
  • the universal cord 206 (also known as an“umbilical cable”) connects the light guide section 208 to the control section 202 of the endoscope.
  • the light guide section 208 provides a source of light which is distributed to the end of the insertion tube 204 using a fiber optic cable or other light guides.
  • the imaging element e.g. camera
  • used for capturing imaging data may be located at in the light guide section 208 or adjacent to the nozzle 220.
  • the various channels of the endoscope 200 allow the passage of fluids and objects, which may result in the contamination throughout the extent of the channels.
  • the portion of the suction channel 230 which extends from the biopsy valve 214 to the distal end of the insertion tube 204 (to the nozzle 220) is also known as the biopsy channel.
  • the biopsy channel, and the remainder of the suction channel 230 is subject to a high likelihood of contamination and/or damage in the course of an endoscopic procedure.
  • the insertion, manipulation, and extraction of instruments (and biological material attached to such instruments) through the suction channel 230 commonly leads to the placement of microbes within the suction channel 230.
  • any damage to the interior layer(s) of the biopsy channel may also lead to deposits of biological material.
  • Such biological material which remains in cavities, or which congeals in the form of biofilm, may be resistant to many manual cleaning techniques such as brushes pulled through the suction channel.
  • Such damage may also occur in the other channels 228, 230, 232, as a result of usage, deterioration, or failure of components.
  • the techniques discussed herein provide enhanced techniques in connection with the inspection and verification of the integrity of the channels 228, 230, 232, including integrity from damages or defects, and/or integrity from deposited biological materials and contamination.
  • FIG. 3 illustrates data flows 300 provided with an example cleaning workflow and tracking system 380, during respective stages of endoscope use and processing, including the use of a borescope inspection system 350 and visual inspection processing system 360 used to perform an integrity verification of one or more endoscope channels.
  • the data flows 300 specifically illustrate the generation and communication of data as an endoscope is handled or used at various locations. These include: status of the endoscope at a storage facility 310 (e.g., the storage unit 152 in the storage stage 150), as indicated via status data (e.g., a location and sterilization status of the endoscope); status of the use of the endoscope at a procedure station 320 (e.g., as handled in the procedure use stage 110), as indicated via procedure data (e.g., an identification of a patient, physician, and handling details during the procedure); status of the testing of the endoscope at a testing station 330 (e.g., at a leak or component test device), as indicated via test result data (e.g., a pass or fail status of a test, measurement values, etc.); status of the manual cleaning actions performed at a manual cleaning station 340 (e.g., as performed by the technician 122), as indicated by inspection data (e.g., a status that logs the timing and result of
  • the location of the endoscope among the stations, and activities performed with the endoscope may be performed in connection with specific device handling workflow.
  • a workflow may include a step-by-step cleaning procedure, maintenance procedures, or a tracking workflow, to track and manage a disinfected or contaminated status, operational or integrity status, or cleaning procedure status of the endoscope components or related equipment.
  • the subject endoscope may be identified using a tracking identifier unique to the endoscope, such as a barcode, RFID tag, or other identifier coupled to or communicated from the endoscope.
  • the manual cleaning station 340 and automated cleaning station 370 may host an identifier detector to receive identification of the particular endoscope being cleaned at the respective cleaning station.
  • the identifier detector comprises a RFID interrogator or bar code reader used to perform hands-free identification.
  • a user interface may be output to a human user via a user interface device (e.g., a display screen, audio device, or combination).
  • a user interface device e.g., a display screen, audio device, or combination.
  • the user interface may request input from the human user to verify whether a particular cleaning protocol has been followed by the human user at each of the testing station 330, manual cleaning station 340 and automated cleaning station 370.
  • a user interface may also output or receive
  • the input to such user interface may include any number of touch or touch-free (e.g., gesture, audio command, visual recognition) inputs, such as with the use of touchless inputs to prevent contamination with an input device.
  • input recognition used for control or identification purposes may be provided within logic or devices of any of the stations 310, 320, 330, 340, 370, or as interfaces or controls to the borescope inspection system 350 or the visual inspection processing system 360.
  • tracking of patients, cleaning personnel, technicians, and users or handlers of the endoscope may be tracked within the data values communicated to the cleaning workflow and tracking system 380.
  • the interaction with the cleaning workflow and tracking system 380 may also include authentication and logging of user identification information, including validation of authorized users to handle the device, or aspects of user- secure processing.
  • a variety of inquiries, prompts, or collections of data may occur at various points in a device cleaning or handling workflow, managed by the cleaning workflow and tracking system 380, to collect and output relevant data.
  • data may be managed for procedure validation or quality assurance purposes, for example, to obtain human verification that a cleaning process has followed proper protocols, or that human oversight of the cleaning process has resulted in a satisfactory result.
  • Workflow steps may also be required by the workflow and tracking system 380 to be performed in a determined order to ensure proper cleaning, and user inquiries and prompts may be presented in a determined order to collect full information regarding compliance or procedure activities.
  • the cleaning workflow and tracking system 380 may be used to generate an alert or display appropriate prompts or information if a user or device does not fully complete certain steps or procedures. For example, a status of the lumen inspection can be traced using the cleaning workflow and tracking system 380. In some of these examples, whether the lumen of the catheter is or is not compromised can be determined using the cleaning workflow and tracking system 380 and the devices, systems and methods discussed below with reference to FIGS. 5-12.
  • FIG. 4 is a block diagram of system components used to interface among example imaging, tracking, and processing systems.
  • the components of the borescope inspection system 350 may include a borescope imaging device 352, which is operably coupled to a movement control device 354.
  • the borescope inspection system 350 may provide video or imaging output in connection with imaging of internal channels of the endoscope 410.
  • the use of the borescope inspection system 350 may be tracked and managed as part of an inspection procedure in a cleaning workflow, with resulting tracking and inspection data facilitated by the cleaning workflow and tracking system 380.
  • the cleaning workflow and tracking system 380 may include functionality and processing components used in connection with a variety of cleaning and tracking purposes involving the endoscope 410.
  • Such components may include device status tracking management functionality 422 that utilizes a device tracking database 426 to manage data related to status(es) of contamination, damage, tests, and usage for the endoscope 410 (e.g., among any of the stages 110, 120, 140, 150).
  • Such components may also include a device cleaning workflow
  • management functionality 424 used to track cleaning, testing, verification activities, initiated as part of a cleaning workflow for the endoscope 410 (e.g., among the reprocessing stages 120,
  • the workflow management database 428 may log the timing and performance of specific manual or automatic cleaning actions, the particular amount or type of cleaning or disinfectant solution applied, which user performed the cleaning action, and the like.
  • the data and workflow actions in the cleaning workflow and tracking system 380 may be accessed (e.g., viewed, updated, input, or output) through use of a user computing system 430, such as with an input device 432 and output device 434 of a personal computer, tablet, workstation, or smartphone, operated by an authorized user.
  • the user computing system 430 may include a graphical user interface 436 to allow access to the data and workflow actions before, during, or after any of the handling or cleaning stages for the endoscope 410 (e.g., among any of the stages 110, 120, 140, 150).
  • the user computing system 430 may display a real time status of whether the endoscope 410 is disinfected, which tests have been completed and passed during cleaning, and the like.
  • the visual inspection processing system 360 is shown as also including functionality and processing components used in connection with analysis of data from the borescope inspection system 350, and/or the cleaning workflow and tracking system 380.
  • video captured by a borescope imaging device 352, advanced within a channel of the endoscope 410 at a particular rate by the movement control device 354 may be captured in real-time through use of inspection video capture processing 362.
  • the respective images or video sequences captured are subjected to image pre-processing 364, such as to enhance, crop, or modify images from the borescope imaging device 352.
  • respective images or sequences of images are input into an image recognition model 366 for computer analysis of the integrity state of the captured channel.
  • the visual inspection processing performed by the processing system 360 may occur in real time with coordinated use (and potentially, automated or machine- assisted control) of the borescope inspection system 350, or as part of a subsequently performed inspection procedure.
  • the image recognition model 366 may be a machine-learning image classifier which is trained to identify normal (full integrity) conditions of an imaged channel lumen, versus abnormal (compromised integrity) conditions of the imaged channel lumen. Such abnormal conditions may include the existence of damage or defects to the lumen, the deposit of biological material on the lumen, etc.
  • Other types and forms of artificial intelligence processing may also be used in combination with the image recognition model 366.
  • the results (e.g., classification or other data outputs) from the image recognition model 366 may be output via the user computing system 430, or recorded in the cleaning workflow and tracking system 380.
  • FIG. 5 illustrates a perspective view of a portion of a borescope 502 within a lumen 504 of an endoscope (such as endoscope 200 of FIG. 2), in accordance with at least one example of the present disclosure.
  • the lumen 504 can include a body 506, a wall 508, a lumen 510, and an internal surface 512.
  • FIG. 5 also shows a directional arrow A, cross-section indicators 6-6, and orientation indicators Proximal and Distal.
  • the lumen 504 can include a pattern or identifier on an internal surface of a wall of the lumen, where the pattern can enable detection of a compromised state of the lumen (or a lack of compromise to the lumen). Any of the previously discussed lumens or channels can be modified to include such a pattern.
  • the lumen 504 can be a relatively small tube or cylindrical member configured to receive a borescope and other tools therethrough, such as forceps, snares, retractors, scalpels, or the like.
  • the lumen 504 can be one of the channels 226, 228, 230, and 232 discussed above with respect to the endoscope 200 of FIG. 2.
  • the body 506 can be a rigid or semi-rigid body comprised of materials such as metals, plastics, foams, elastomers, ceramics, composites, and combinations thereof.
  • the body 506 can be relatively flexible for navigation through curved pathways within cavities and organs of a human body.
  • the wall 508 can be a circumferential wall of the body 506 and can define one or more lumens therein, such as the lumen 510.
  • the wall can include multiple layers, as discussed below.
  • the wall 508 can include the internal surface 512, which can be made of one or more materials and one or more patterns, as discussed below in further detail.
  • the borescope 502 can be inserted into (for example) a proximal end of the body 506 and into the lumen 510 in direction A.
  • the borescope 502 can be used to inspect the internal surface 512 of the body 506. During inspection, the borescope 502 can be advanced by a human or a machine within the lumen 510.
  • the borescope 502 may produce image data (such as image data 132) that can be used to provide a detailed, high-resolution view of the status of the internal surface 512 of the lumen 510.
  • the image data may be provided to a computing system (such as the computing system 130) for processing and analysis.
  • the results of the borescope inspection procedure may be tracked or managed as part of a device tracking or cleaning workflow, including with the aforementioned tracking system.
  • the internal surface 512 may include an identifier, such as a pattern, detectable by the borescope and indicated by a display (and/or a computing system).
  • a computing system can analyze data received from the borescope to detect a compromised state (or a lack of a compromised state) of the inner surface 512 of the wall 508.
  • a compromised state can be damage to or a biological deposit on the inner surface 512.
  • FIG. 6A illustrates a focused perspective view of a portion of the borescope 502 within the lumen 504 of an endoscope across indicators 6-6 of FIG. 5, in accordance with at least one example of the present disclosure.
  • FIG. 6B illustrates a further focused perspective view of a portion of the borescope 502 within the lumen 504 of an endoscope as indicated by 6B of FIG. 6A, in accordance with at least one example of the present disclosure.
  • FIGS. 6A and 6B are discussed below concurrently.
  • the borescope 502 and the lumen 510 can be consistent with those of FIG. 5, except that FIGS. 6A and 6B show additional details of the lumen 504 and the lumen 510, such as the internal surface 512 of the wall 508 of the lumen 504.
  • the borescope 502 can include an optical portion 514 (which can have a detection range 516).
  • the lumen 504 can include the body 506, the wall 508, the lumen 510, and the internal surface 512.
  • the wall 508 of the lumen 504 can also include indicators 520A-520C (collectively referred to as the identifier 520). Also shown are damage 522 and a biological deposit 524.
  • FIG. 6A also shows a view indicator 6B, section indicators 7-7, and orientation indicators Proximal and Distal.
  • the optical portion 514 of the borescope can include a lens or focusing mechanism that can determine the detection range 516. In some examples, the detection range can be longer and/or wider (radially).
  • the optical portion 514 can further include a light source for illuminating the inner surface 512 of the wall 508.
  • the optical portion 514 can include a video recording device for producing and/or storing image data.
  • the identifier 520 can be a pattern on and/or a layer in the inner surface 512 of the wall 508. In some examples, the identifier 520 can be a variation in color or texture from the inner surface 512. In other examples, the identifier 520 can be an electrical or magnetic component. In the example shown in FIGS. 6A and 6B, the identifier 520 can be an arrangement of circles or cylinders extending around an inner circumference (of the inner surface 512) of the wall 508 where the individual identifiers (such as identifiers 520A, 520B, and 520C) are equally spaced from each other along an axial length of the wall 508.
  • the damage 522 can be a rip, tear, cut, protrusion, abrasion, fissure, hole or other imperfection or damage to the internal surface 512.
  • the biological deposit 524 can be a foreign object of biological matter such as (generally) soil, biofilm, tissue, other bodily fluids or solids, or the like.
  • the damage 522 and the biological deposit can be small relative to the size of the lumen 504, which can be a relatively small device. This can make detection of such damage and/or biological deposits difficult using the human eye or through image processing software through a visual inspection processing system, such as system 360 of FIG. 4.
  • the borescope 502 can be passed through the lumen 510 for inspection of the inner surface 512 of the wall 508.
  • the optical portion 514 of the borescope 502 can view the inner surface 512 over the detection range 516.
  • the visual inspection processing system 360 can determine whether or not the internal surface 512 is in a compromised state. That is, whether the internal surface 512 is damaged and/or whether the internal surface contains any biological matter.
  • the visual inspection processing system 360 can determine that the internal surface is not in a compromised state.
  • the identifier 520 is interrupted, such as by the damage 522 and the biological deposit 524, the optical portion 514 of the visual inspection processing system 360 can determine that the internal surface 512 is in a compromised state. More specifically, the damage 522 interrupts the identifiers 520B and 520C by physically breaking the lines or cylinder shapes of the identifiers 520B and 520C.
  • the optical portion 514 can detect such a break in the continuity of the identifier 520 and can provide a signal to another system or operator which can analyze the signal or a visual representation thereof to determine that a compromised state exists.
  • the biological deposit 524 can disrupt the pattern of the identifier 520. As shown in FIGS. 6A and 6B, the biological deposit 524 can partially cover the identifiers 520A, 520B, and 520C. When the optical portion 514 approaches the biological deposit 524, the visual inspection processing system 360 can detect the disruption in the identifier 520, and can determine that the internal surface 512 is in a
  • the lumen 504 can help reduce inspection time during reprocessing of endoscopes, can help prevent equipment failures from missed damage to the internal surface, and can help to prevent transmission of biological material between patients and procedures. In this way, the lumen 504 can enable detection of a compromised state despite the damage or biological deposit being relatively small.
  • FIG. 7A illustrates a focused side view of an internal portion 702 of a lumen 700 of an endoscope, in accordance with at least one example of the present disclosure.
  • the lumen 700 can include a square array pattern or identifier on an internal surface of a wall of the lumen, where the pattern can enable detection of a compromised state of the lumen (and/or the lack of damage or compromise to the lumen). Any of the previously discussed lumens or channels can be modified to include such a pattern.
  • the lumen 700 can include the internal portion 702, a wall 704, an internal surface 706, horizontal identifiers 708A-708N, and vertical identifiers 710A-710N. Also shown in FIG. 7A is axis A.
  • the lumen 700 can be similar to the lumen 504 of FIGS. 5-6B except that the lumen 700 can include horizontal and vertical identifiers that can form a square or grid pattern in and/or on the surface 706 of the lumen 700. That is horizontal identifiers 708A-708N can be substantially parallel with axis A and vertical identifiers 710A-710N can be at angle of substantially 90 degrees with respect to axis A and to the horizontal identifiers 708A-708N.
  • the horizontal identifiers 708A-708N can extend along a length of the internal surface 706 of the lumen 700 and can be substantially equally spaced around a circumference of the inner surface 706 of the lumen 700, in some examples. In other examples, the horizontal identifiers 708A-708N can be unevenly spaced, for example, to provide an indication of position or orientation of the optical device, or to provide a location (along a length, for example) of the optical device within the lumen 700.
  • the number of horizontal identifiers 708A-708N can be 1,
  • the vertical identifiers 710A-710N can each extend around an inner circumference of the internal surface 706 of the lumen 700 and can be substantially equally spaced, in some examples, along a length of the lumen 700. In other examples, the vertical identifiers 710A-710N can be unevenly spaced, for example, to provide an indication of position or orientation of the optical device, or to provide a location (along a length, for example) of the optical device within the lumen 700.
  • the number of vertical identifiers 710A-710N can be 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 15, 20, 30, 40, or the like. Further, by varying the number or spacing of either of the horizontal identifiers 708A-708N or the vertical identifiers 710A-710N, the indication patter of the lumen 700 can be rectangular grid.
  • the horizontal identifiers 708A-708N and the vertical identifiers 710A- 710N can form a substantially square grid pattern or array, which can help to determine whether or not a compromised state or condition of the internal surface 706 (such as damage or a biofilm) is present.
  • a compromised state or condition of the internal surface 706 such as damage or a biofilm
  • the identifiers 708 and 710 can help to increase the accuracy of the determination of whether a compromised state exists in the lumen 700, helping to improve reprocessing speed and completeness.
  • FIG. 7A illustrates a focused side view of an internal portion 802 of a lumen 800 of an endoscope, in accordance with at least one example of the present disclosure.
  • the lumen 800 can include a hexagonal array pattern or identifier on an internal surface of a wall of the lumen 800, where the pattern can enable detection of a compromised state of the lumen 800 (and/or the lack of damage or compromise to the lumen). Any of the previously discussed lumens or channels can be modified to include such a pattern.
  • the lumen 800 can include the internal portion 802, a wall 804, an internal surface 806, horizontal identifiers 808A-808N, first diagonal identifiers 810A-810N, second diagonal identifiers 812A-812N, and hexagons 814A-814N. Also shown in FIG. 7B is axis A.
  • the lumen 800 can be similar to the lumen 504 of FIGS. 5-6B and the lumen 700 of FIG. 7A, except that the lumen 800 can include horizontal, first diagonal, and second diagonal identifiers that can form a hexagonal grid pattern in and/or on the surface 806 of the lumen 800. That is, horizontal identifiers 808A-808N can be substantially parallel with axis A, first diagonal identifiers 810A-810N can be at angle of substantially 120 degrees with respect to axis A, and second diagonal identifiers 812A-812N can be at angle of substantially 60 degrees with respect to axis A
  • the horizontal identifiers 808A-808N can extend in segments along a length of the internal surface 806 of the lumen 800 and can be substantially equally spaced around a circumference and along the axis A of the inner surface 806 of the lumen 800, in some examples. In other examples, the horizontal identifiers 808A-808N can be unevenly spaced, for example, to provide an indication of position or orientation of the optical device, or to provide a location (along a length, for example) of the optical device within the lumen 800.
  • the number of horizontal identifiers 808A-808N per centimeter of length can be 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 15, 20, 30, 40, or the like.
  • the first diagonal identifiers 810A-810N can each extend around an inner
  • first diagonal identifiers 810A-810N can be unevenly spaced, as described above with respect to other identifiers.
  • the number of first diagonal identifiers 810A-810N per centimeter of length can be 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 15, 20, 30, 40, or the like.
  • the second diagonal identifiers 812-812N can each extend around an inner circumference of the internal surface 806 of the lumen 800 in segments and can be substantially equally spaced, in some examples.
  • the second diagonal identifiers 812A-812N can be unevenly spaced, as described above with respect to other identifiers.
  • the number of second diagonal identifiers 812A-812N per centimeter of length can be 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 15, 20, 30, 40, or the like.
  • the horizontal identifiers 808A-808N, the first diagonal identifiers 810A- 810N, and the second diagonal identifiers 812A-812N can form the hexagons 814A-814N.
  • each of the hexagons 814A-814N can be regular hexagons.
  • the indication pattern of the lumen 800 can be an irregular hexagonal grid.
  • vertical identifiers can be incorporated to create an octagonal grid or pattern. In other examples, various other geometric grids can be used.
  • the hexagonal grid pattern or array can help to determine whether or not a compromised state or condition of the internal surface 806 (such as damage or a biofilm) is present.
  • a compromised state or condition of the internal surface 806 such as damage or a biofilm
  • the identifiers 808, 810, and 812 can help to increase the accuracy of the determination of whether a compromised state exists in the lumen, helping to improve reprocessing speed and completeness.
  • FIG. 7C illustrates a focused side view of an internal portion 902 of a lumen 900 of an endoscope, in accordance with at least one example of the present disclosure.
  • the lumen 900 can include a rifled or helical array pattern or identifier on an internal surface of a wall of the lumen. Such a pattern can enable detection of a compromised state of the lumen 900 (and/or the lack of damage or compromise to the lumen). Any of the previously discussed lumens or channels can be modified to include a rifled or helical pattern.
  • the lumen 900 can include the internal portion 902, a wall 904, an internal surface 906, helical identifiers 908A-908N, a control device 910, and a connector 912. Also shown in FIG. 8 is axis A.
  • the lumen 900 can be similar to the lumen 504 of FIGS. 5-6B, the lumen 700 of FIG. 7 A, and the lumen 800 of FIG. 7B, except that the lumen 900 can include helical identifiers that can form a single identifier within the lumen 900. That is, the helical identifiers 908A-908N can extend around a circumference of the internal surface 906 of the lumen 900 and extend along an axial length of the lumen such that the helical identifiers 908A-908N form a rifle pattern or helical pattern of a single identifier within internal portion 902 about axis A.
  • the helical identifiers 908A-908N can be substantially equally spaced around a circumference and along the axis A of the inner surface 906 of the lumen 800.
  • the helical identifiers 908A-908N can be unevenly spaced, for example, to provide an indication of position or orientation of the optical device, or to provide a location (along a length, for example) of the optical device within the lumen 800.
  • the number of helical identifiers 908A-908N per centimeter can be 0.25, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 15, 20, 30, 40, or the like.
  • the helical identifiers 908A-908N can form a continuous helix or rifle around the internal surface 906 of the lumen 900, meaning that the helical identifier 908 can be a single identifier or component.
  • the single component can be a printed pattern or layer.
  • the single component can be an electrical trace on the internal surface 906 or embedded in the wall 904 of the lumen 900. the latter example, the identifier 908 can be connected to the control device 910 via the connector 912.
  • control device 910 can connect to the visual processing system 360, the cleaning workflow and tracking system 380, and/or the user computing system 430 of FIG. 4.
  • a signal e.g., a control-level voltage or current
  • a signal returned by the identifier 908 can be used to analyze a signal returned by the identifier 908.
  • Analysis of the returned signal can indicate a compromised state of the internal surface 906, such as damage or a biological deposit.
  • a voltage or current indicating that the identifier 908 (or circuit created thereby) is open can be used to determine that damage exists within the lumen 900.
  • a voltage or current indicating that the identifier 908 (or circuit created thereby) is shorted can indicate that a biological deposit exists and is bridging one or more of the helical identifiers 908A-908N.
  • the helical identifier can be a permanent magnetic or electromagnetic component.
  • the electromagnetic signal can include a magnetic field and the damaged portion can be identified by sensing an induced electromagnetic response to the delivered magnetic field.
  • a magnetic or electromagnetic signature or signal of the helical identifier can be analyzed using a sensor inserted into and/or passed over the lumen.
  • Irregularities to, or variances in, the signature and/or signal can indicate a
  • a single, continuous helical identifier can help to provide a second method of detecting a compromised state (in addition to optical detection) of the internal surface 906 of the lumen 900, which can help improve reprocessing quality and efficiency.
  • the control device 910 can analyze an electrical signature of the electrical traces (of the helical identifiers 908A-908N).
  • the electrical signature can be one or more of a resistance of the helical identifiers 908A-908N, an impedance of the helical identifiers 908A- 908N, or an electrostatic charge of the helical identifiers 908A-908N. Changes to one or more of the properties of the electrical signature detected by the control device 910 can indicate a compromised state of the internal surface 906, such as damage or a biological deposit.
  • FIG. 7D illustrates a focused side view of an internal portion 902 of a lumen 900 of an endoscope, in accordance with at least one example of the present disclosure.
  • the lumen 900 can include the internal portion 902, the wall 904, the internal surface 906, first helical identifiers 908A-908N, and second helical identifiers 914A-914N. Also shown in FIG. 7D is axis A.
  • the lumen 900 of FIG. 7D can be the same as lumen 800 of FIG. 7C, but FIG. 7D shows that lumen 900 can include first helical identifiers 908A-908N and second helical identifiers 914A-914N.
  • the first helical identifiers 908A-908N and second helical identifiers 914A-914N can form a crossing double helical pattern or an intersecting rifle pattern.
  • Such a pattern can provide a pattern or grid of identifiers running in multiple directions to help ensure that a compromised state is detected when one is present.
  • the first helical identifiers 908A-908N can form a single identifier 908 along a length of the internal surface 906 and the second helical identifiers 914A-914N can form a single identifier 914 along a length of the internal surface 906.
  • the first identifier 908 and the second identifier 914 can each be electrical and/or magnetic components.
  • the first identifier 908 can be an electrical component and the second identifier 914 can be a magnetic component.
  • both the first identifier 908 and the second identifier 914 can be electrical components.
  • both the first identifier 908 and the second identifier 914 can be magnetic components.
  • first identifier 908 and the second identifier 914 can connect to form a single circuit.
  • first identifier 908 and the second identifier 914 can be radially spaced away from each other (for example in layers of the wall 904) to create multiple circuits.
  • Irregularities to or variances in the circuit(s) and/or electric or electromagnetic signature(s) created by the first identifier 908 and the second identifier 914 can help to indicate a compromised state of the internal surface 906, such as damage or a biological deposit.
  • a dual continuous helical patterned identifier can help to provide multiple ways of detecting a compromised state of the internal surface 906 of the lumen 900, which can help improve reprocessing quality and efficiency.
  • FIGS. 7A and 7B are discussed below concurrently.
  • first helical identifiers 908A-908N and the second helical identifiers 914A-914N can be equally spaced and consistently opposing. However, in some examples, spacing of the first helical identifiers 908A-908N and the second helical identifiers 914A-914N can vary about the axis and/or circumference of the lumen 900. In other examples, respective angles of the first helical identifiers 908A-908N and the second helical identifiers 914A-914N can vary within the lumen 900 to indicate a location or orientation of the lumen 900.
  • lumen 900 of FIG. 7D is shown and discussed above as having a double helix pattern, a triple, quadruple, or the like pattern can be used in other examples.
  • FIG. 8A illustrates a cross-section view across section 8-8 of FIG. 5 of a lumen 1000 of an endoscope, in accordance with at least one example of the present disclosure.
  • FIG. 8B illustrates a focused cross-section view of a portion 8B of the lumen 1000 of an endoscope, in accordance with at least one example of the present disclosure.
  • the lumen 1000 can include multiple layers which can help identify the presence of a compromised state of the lumen 1000. Any of the previously discussed examples can include a layered lumen.
  • the lumen 1000 can include a wall 1004, an internal surface 1006, an identifier 1008, and a lumen 1010.
  • the wall 1004 can include a first layer 1012, a second layer 1014, and a third layer 1016. Also shown in FIG. 8A is sensor 1002 and indicator 8B. Also shown in FIG. 8B are orientation indicators Inside and Outside. [0112]
  • the first layer 1012 can have a first fluorescence property or behavior and the second layer 1014 can have a second fluorescence property or behavior.
  • the fluorescence of the first layer 1012 can be less intense than the fluorescence the second layer 1014.
  • the first layer 1012 behavior can be non-fluorescence and the second layer behavior can be fluorescent so that an examination of the internal surface 1006 using, for example, the sensor 1002, can allow a person or system to easily determine whether the internal surface 1006 is in a compromised state. That is, when damage removes a portion of the first layer 1012, the second layer can be exposed and can fluoresce to indicate the presence of the damage.
  • identifiers 1008 are shown in FIGS. 8A and 8B, in some examples the layers 1012, 1014, and 1016 can be sufficient to determine the existence of a compromised state (or the lack thereof). In some of these examples, layer 1014 can be omitted.
  • a compound causing biological material to appear fluorescent can be used so that when any fluorescence is detected, such fluorescence indicates that the internal surface 1006 is in a compromised state and when no fluorescence is detected, the internal surface is not in a compromised state.
  • each of the three layers 1012, 1014, and 1016 can have different fluorescent properties to allow a depth of damage to be assessed (because the thickness of the layers can be known). For example, if a fluorescence signal emitted by the third layer 1016 is detected, it can indicate that damage to the lumen 1000 is relatively deep.
  • the layers 1012, 1014, and 1016 can configured to fluoresce in different colors.
  • the first layer 1012 can be have a first color and the second layer 1014 can have a second color.
  • the color of the first layer 1012 can be black and the color of the second layer 1014 can be red.
  • each of the three layers 1012, 1014, and 1016 can have different colors to allow a depth of damage to be assessed (because the thickness of the layers can be known). For example, if a color of the third layer 1016 (for example blue) is detected, it can indicate that damage to the lumen 1000 is relatively deep.
  • the identifier 1008A can be attached or secured to a radially inner portion of the first layer 1012.
  • a second identifier 1008C can also be attached or secured to a radially inner portion of the first layer 1012.
  • Such examples can include printing or attachment of the identifiers 1008 A and 1008C to the internal surface 1006.
  • the identifiers 1008 A and 1008C can be attached to the internal surface 1006 using an adhesive or using a hot air welding technique.
  • the identifier 1008B can be embedded into the first layer 1012. In other examples, the identifiers 1008B can be embedded into two or more layers. As discussed above, the identifier 1008B can be an electrical (or magnetic) identifier and can be embedded in the first layer 1012 to avoid interaction with the identifiers 1008 A and/or 1008C. In some examples, the identifier 1008B can be slightly recessed in the first layer 1012 to help reduce contact with crossing identifiers (such as identifier 1008A at another location in the lumen 1000). In other examples, the identifier 1008B can be flush with the internal surface 1006.
  • FIG. 9 is a block diagram illustrating an example computer system machine upon which any one or more of the previous techniques may be performed or facilitated by.
  • Computer system 1100 specifically may be used in connection with facilitating the operations of the cleaning workflow and tracking system 380, the visual inspection processing system 360, the user computing system 430, or any other computing platform described or referred to herein.
  • the computer system 1100 can be connected to the control device 910 and/or to the borescope 502 for processing of images and signals produced during visual and electrical or electromagnetic, respectively, inspection of the lumens and lumens discussed herein.
  • the machine operates as a standalone device or may be connected (e.g., networked) to other machines.
  • the machine may operate in the capacity of either a server or a client machine in server-client network
  • Example computer system 1100 includes a processor 1102 (e.g., a central processing unit (CPU), a graphics processing unit (GPU) or both), a main memory 1104 and a static memory 1106, which communicate with each other via a link 1108 (e.g., an interlink, bus, etc.).
  • processor 1102 e.g., a central processing unit (CPU), a graphics processing unit (GPU) or both
  • main memory 1104 e.g., a main memory 1104
  • static memory 1106 e.g., an interlink, bus, etc.
  • the computer system 1100 may further include a video display unit 1110, an alphanumeric input device 1112 (e.g., a keyboard), and a user interface (UI) navigation device 1114 (e.g., a mouse).
  • UI user interface
  • the video display unit 1110, input device 1112 and UI navigation device 1114 are a touch screen display.
  • the computer system 1100 may additionally include a storage device 1116 (e.g., a drive unit), a signal generation device 1118 (e.g., a speaker), and a network interface device 1120 which may operably communicate with a communications network 1126 using wired or wireless communications hardware.
  • the computer system 1100 may further include one or more human input sensors 1128 configured to obtain input (including non-contact human input) in accordance with input recognition and detection techniques.
  • the human input sensors 1128 may include a camera, microphone, barcode reader, RFID reader, near field communications reader, or other sensor producing data for purposes of input.
  • the computer system 1100 may further include an output controller 1130, such as a serial (e.g., universal serial bus (USB), parallel, or other wired or wireless (e.g., infrared (IR)) connection to communicate or control one or more peripheral devices (e.g., a printer, card reader, etc.).
  • serial e.g., universal serial bus (USB)
  • parallel e.g., parallel, or other wired or wireless (e.g., infrared (IR)) connection to communicate or control one or more peripheral devices (e.g., a printer, card reader, etc.).
  • IR infrared
  • the storage device 1116 may include a machine-readable medium 1122 on which is stored one or more sets of data structures or instructions 1124 (e.g., software) embodying or utilized by any one or more of the methodologies or functions described herein.
  • the instructions 1124 may also reside, completely or at least partially, within the main memory 1104, static memory 1106, and/or within the processor 1102 during execution thereof by the computer system 1100, with the main memory 1104, static memory 1106, and the processor 1102 also constituting machine-readable media.
  • machine-readable medium 1122 is illustrated in an example embodiment to be a single medium, the term“machine-readable medium” may include a single medium or multiple media (e.g., a centralized or distributed database, and/or associated caches and servers) that store the one or more instructions 1124.
  • the term“machine-readable medium” shall also be taken to include any tangible medium (e.g., a non-transitory medium) that is capable of storing, encoding or carrying instructions for execution by the computer system 1100 and that cause the computer system 1100 to perform any one or more of the methodologies of the present disclosure or that is capable of storing, encoding or carrying data structures utilized by or associated with such instructions.
  • machine-readable medium shall accordingly be taken to include, but not be limited to, solid-state memories, and optical and magnetic media.
  • machine-readable media include non-volatile memory, including, by way of example, semiconductor memory devices (e.g., Electrically Programmable Read-Only Memory (EPROM), Electrically Erasable Programmable Read-Only Memory (EEPROM)) and flash memory devices; magnetic disks such as internal hard disks and removable disks; magneto optical disks; and CD-ROM and DVD-ROM disks.
  • semiconductor memory devices e.g., Electrically Programmable Read-Only Memory (EPROM), Electrically Erasable Programmable Read-Only Memory (EEPROM)
  • flash memory devices e.g., Electrically Programmable Read-Only Memory (EPROM), Electrically Erasable Programmable Read-Only Memory (EEPROM)
  • flash memory devices e.g., Electrically Programmable Read-Only Memory (EPROM), Electrically Erasable Programmable Read-Only Memory (EEPROM)
  • flash memory devices
  • the instructions 1124 may further be transmitted or received over a communications network 1126 using a transmission medium via the network interface device 1120 utilizing any one of a number of well-known transfer protocols (e.g., frame relay, internet protocol (IP), transmission control protocol (TCP), user datagram protocol (UDP), hypertext transfer protocol (HTTP)).
  • transfer protocols e.g., frame relay, internet protocol (IP), transmission control protocol (TCP), user datagram protocol (UDP), hypertext transfer protocol (HTTP)
  • Examples of communication networks include a local area network (LAN), wide area network (WAN), the Internet, mobile telephone networks, Plain Old Telephone (POTS) networks, and wireless data networks (e.g., Wi-Fi, 3G, and 4G LTE/LTE-A or 5G networks).
  • transmission medium shall be taken to include any intangible medium that is capable of storing, encoding, or carrying instructions for execution by the computing system 1100, and includes digital or analog communications signals or other intangible medium to facilitate communication of such software.
  • computing embodiments described herein may be implemented in one or a combination of hardware, firmware, and software. Embodiments may also be implemented as instructions stored on a computer-readable storage device, which may be read and executed by at least one processor to perform the operations described herein.
  • a computer-readable storage device may include any non-transitory mechanism for storing information in a form readable by a machine (e.g., a computer).
  • a computer- readable storage device may include read-only memory (ROM), random- access memory (RAM), magnetic disk storage media, optical storage media, flash-memory devices, and other storage devices and media.
  • ком ⁇ онент or modules may be implemented in any combination of hardware circuits, programmable hardware devices, other discrete components. Components or modules may also be implemented in software for execution by various types of processors.
  • An identified component or module of executable code may, for instance, comprise one or more physical or logical blocks of computer instructions, which may, for instance, be organized as an object, procedure, or function. Nevertheless, the executables of an identified component or module need not be physically located together, but may comprise disparate instructions stored in different locations which, when joined logically together, comprise the component or module and achieve the stated purpose for the component or module. Indeed, a component or module of executable code may be a single instruction, or many instructions, and may even be distributed over several different code segments, among different programs, and across several memory devices.
  • operational data may be identified and illustrated herein within components or modules, and may be embodied in any suitable form and organized within any suitable type of data structure.
  • the operational data may be collected as a single data set, or may be distributed over different locations including over different storage devices, and may exist, at least partially, merely as electronic signals on a system or network.
  • the components or modules may be passive or active, including agents operable to perform desired functions.
  • FIG. 10 illustrates a schematic view of a method 1200, in accordance with at least one example of the present disclosure.
  • Method 1200 can be a method of identifying a compromised state of an internal surface of a lumen, such as damage or the presence of biological material.
  • Method 1200 includes operations performed by multiple different actors, devices, and/or systems. It is understood that subsets of the operations discussed in method 1200 attributable to a single actor, device, or system could be considered a separate standalone process or method.
  • Method 1200 can begin at step 1202 where a signal can be delivered to an interior surface of a lumen.
  • a signal produced by the control device 910 (which can be connected to the borescope inspection system 350, the cleaning workflow and tracking system 380, and/or the visual inspection system 360 of FIG. 4) can be delivered to the interior surface 906 of the lumen 900.
  • a signal modified by the interior surface (or the identifier) can be received.
  • a signal modified by the interior surface 512 can be received at the control device 910.
  • a damaged portion of the interior surface of the lumen can be identified based upon the received signal. For example, damage 522 of interior surface 512 of the lumen 504 can be identified based on the received signal.
  • the signal can include visible light (for example the detection range 516 produced by the borescope 502) and can be used to identify the damaged portion 522 by presenting a camera image on a user interface (such as the user interface 436), where an interruption to the pattern (such as the identifier 520) is visually detectable in the camera image.
  • a user interface such as the user interface 436
  • the signal can include visible light and identifying a damaged portion can include analyzing a camera image with a machine learning model (using the computing system 130) to identify an interruption to the pattern.
  • the interruption to the pattern can be identified (e.g., classified) by the machine learning model as biological material.
  • the interruption to the pattern can be identified by the machine learning model as damage to a layer of the lumen.
  • the signal can include an electrical signal and the damaged portion of the interior surface of the lumen can be identified by detecting an electromagnetic property of the damaged portion.
  • the electromagnetic signal can include a magnetic field and the damaged portion can be identified by sensing an induced electromagnetic response to the delivered magnetic field.
  • FIG. 11 illustrates a schematic view of a method 1300, in accordance with at least one example of the present disclosure.
  • Method 1300 can be a method of manufacturing a lumen including multiple layers. The steps or operations of method 1300 are illustrated in a particular order for convenience and clarity, as described above with respect to method 1200.
  • Method 1300 can begin at step 1302, where a first layer that defines an interior lumen can be formed.
  • the first layer 1012 can be formed to define the lumen 1010.
  • a second layer can be formed below the first layer.
  • the second layer 1014 can be formed below the first layer 1012.
  • the second layer can have an appearance that is different than the first layer (such as a color difference).
  • an electromagnetic or electrical trace can be formed in and/or on the first layer.
  • the identifier 1008 can be formed in and/or on the first layer 1012.
  • damage to the interior lumen is detectable based upon damage to the electromagnetic trace.
  • the second layer can be a different color than the first layer.
  • the second layer can have fluorescence properties that are different than the fluorescence properties of the first layer.
  • FIG. 12 illustrates a schematic view of a method 1400, in accordance with at least one example of the present disclosure.
  • Method 1400 can be a method of reprocessing an endoscope lumen. The steps or operations of method 1400 are illustrated in a particular order for convenience and clarity, as described above with respect to method 1200.
  • Method 1400 can begin at step 1402, where an internal surface of an endoscope lumen can be cleaned.
  • the internal surface 1006 of the lumen 1000 can be cleaned.
  • the interior surface of the lumen can be inspected using a sensor engageable with the endoscope lumen.
  • the internal surface 1006 of the lumen 1000 can be inspected using the sensor 1002 (which can be a borescope in some examples), where the sensor 1002 is engageable with the endoscope lumen 1000.
  • a sensor signal can be produced based on an identifier of the interior surface.
  • the sensor 1002 can produce a signal based on the identifier 1008 of the internal surface 1006.
  • a disruption or a lack of disruption can be detected in the identifier that indicates whether a compromised state of the internal surface is present.
  • the damage 522 and/or the biological deposit 524 can create a disruption in the identifier 520 that indicates that a compromised state of the internal surface 512 is present.
  • the compromised state indicates presence of at least one of biological material on the interior surface and damage to the interior surface.
  • Additional examples of the presently described method, system, and device embodiments include the following, non-limiting configurations. Each of the following non limiting examples may stand on its own, or may be combined in any permutation or combination with any one or more of the other examples provided below or throughout the present disclosure.
  • Example 1 is an endoscope lumen comprising: an elongated body comprising a wall including an interior surface and defining a lumen extending at least partially through the body, the interior surface forming an identifier exposed to the lumen, the identifier configured to indicate damage to the interior surface through an indication of a disruption in the identifier.
  • Example 2 the subject matter of Example 1 optionally includes wherein the identifier is formed at least in part by a pattern on the interior surface.
  • Example 3 the subject matter of any one or more of Examples 1-2 optionally include wherein the identifier is configured to indicate a presence of foreign material on the interior surface through the indication of the disruption in the identifier.
  • Example 4 the subject matter of any one or more of Examples 1-3 optionally include wherein the interior surface includes a first portion and a second portion, the first portion including a first identifier having a first appearance, and the second portion including a second identifier having a second appearance different from the first appearance.
  • Example 5 the subject matter of any one or more of Examples 1-4 optionally include wherein the wall includes a first layer having a first appearance on the interior surface, and the wall includes a second layer radially outward of the first layer, the second layer having a second appearance that is different than the appearance of the first layer, wherein damage to the first layer is detectable based upon the appearance of the second layer.
  • Example 6 the subject matter of Example 5 optionally includes wherein the first appearance is a first color and the second appearance is a second color.
  • Example 7 the subject matter of any one or more of Examples 5-6 optionally include wherein the first appearance is a first fluorescence behavior and the second appearance is a second fluorescence behavior.
  • Example 8 the subject matter of any one or more of Examples 5-7 optionally include wherein the wall includes a third layer radially outward of the second layer, the third layer having a third appearance that is different from the first appearance and the second appearance.
  • Example 9 the subject matter of any one or more of Examples 1-8 optionally include wherein the identifier includes a conductive material, and damage is detectable based upon a change in an electrical signature of the conductive material.
  • Example 10 the subject matter of any one or more of Examples 1-9 optionally include wherein the electrical signature is one of a resistance or an impedance of the conductive material.
  • Example 11 the subject matter of any one or more of Examples 1-10 optionally include wherein the identifier includes a magnetic material and damage is detectable based upon a change in an electromagnetic field of the magnetic material.
  • Example 12 is an endoscope comprising the endoscope lumen of Example 1.
  • Example 13 the subject matter of Example 12 optionally includes wherein the endoscope comprises a camera located proximate to a distal end of the elongated body.
  • Example 14 the subject matter of any one or more of Examples 12-13 optionally include wherein the elongated body is provided in a flexible insertion tube extending from a set of controls of the endoscope.
  • Example 15 the subject matter of any one or more of Examples 12-14 optionally include wherein the endoscope lumen provides a biopsy channel to insert, manipulate, and extract an instrument along the length of the elongated body.
  • Example 16 the subject matter of any one or more of Examples 12-15 optionally include wherein the lumen at a first end of the lumen is coupled to a biopsy valve, and wherein the lumen at a second end of the lumen is open adjacent to a camera.
  • Example 17 is an endoscope lumen inspection system comprising: a sensor engageable with an endoscope lumen and configured to produce a sensor signal based on an indicator of an interior surface of the lumen; and a detection system operatively coupled to sensor, the detection system configured detect a disruption in the indicator of the lumen that indicates damage to the interior surface or biological material on the interior surface.
  • the sensor is an optical sensor sized and shaped to be inserted into a lumen of the lumen.
  • Example 19 the subject matter of Example 18 optionally includes a borescope including the optical sensor, the borescope insertable into the lumen.
  • Example 20 the subject matter of any one or more of Examples 17-19 optionally include wherein the sensor signal includes imaging data, and wherein damage in the lumen is detectable by the system based on a visual disruption in the indicator.
  • Example 21 the subject matter of any one or more of Examples 17-20 optionally include wherein the detection system is configured determine that there is no damage to the interior surface or biological material on the interior surface based on the sensor signal of the indicator of the interior surface.
  • Example 22 the subject matter of any one or more of Examples 17-21 optionally include wherein the indicator is formed at least in part by a pattern on the interior surface.
  • Example 23 the subject matter of any one or more of Examples 17-22 optionally include wherein the sensor signal indicates a fluorescence of a damaged portion of the indicator of the lumen.
  • Example 24 the subject matter of any one or more of Examples 17-23 optionally include wherein the sensor is an electromagnetic sensor, wherein the indicator includes a magnetic property, and wherein the detection system detects damage to the interior surface based on the electromagnetic property of the indicator.
  • the sensor is an electromagnetic sensor
  • the indicator includes a magnetic property
  • the detection system detects damage to the interior surface based on the electromagnetic property of the indicator.
  • Example 25 the subject matter of any one or more of Examples 17-24 optionally include wherein the sensor is operably coupled to a circuit to detect an electrical property of the indicator, and wherein the detection system is configured to detect damage based upon a value of the electrical property.
  • Example 26 is a method of detecting damage in a lumen, the method comprising: delivering a signal to an interior surface of a lumen; and identifying a damaged portion of the interior surface of the lumen based upon a received signal modified by the interior surface.
  • Example 27 the subject matter of Example 26 optionally includes wherein the signal includes visible light and identifying a damaged portion includes presenting a camera image on a user interface, wherein an interruption to the pattern is visually detectable in the camera image.
  • Example 28 the subject matter of any one or more of Examples 26-27 optionally include wherein the signal includes visible light and identifying a damaged portion includes analyzing a camera image with a machine learning model to identify an interruption to the pattern.
  • Example 29 the subject matter of Example 28 optionally includes wherein the interruption to the pattern is identified by the machine learning model as biological material.
  • Example 30 the subject matter of any one or more of Examples 28-29 optionally include wherein the interruption to the pattern is identified by the machine learning model as damage to a layer of the lumen.
  • Example 31 the subject matter of any one or more of Examples 26-30 optionally include wherein the signal includes an electrical signal and identifying a damaged portion of the interior surface of the lumen includes detecting an electromagnetic property of the damage portion.
  • Example 32 the subject matter of any one or more of Examples 26-31 optionally include wherein the electromagnetic signal includes a magnetic field and identifying a damaged portion includes sensing an induced electromagnetic response to the delivered magnetic field.
  • Example 33 is a method of manufacturing a lumen comprising: forming a first layer that defines an interior lumen; and forming a second layer below the first layer, the second layer having an appearance that is different than the first layer.
  • Example 34 the subject matter of Example 33 optionally includes wherein the second layer is a different color than the first layer.
  • Example 35 the subject matter of any one or more of Examples 33-34 optionally include wherein the second layer has fluorescence properties that are different than the fluorescence properties of the first layer.
  • Example 36 is a method of manufacturing an endoscope lumen comprising: forming a first layer that defines an interior lumen; and forming an electromagnetic trace in, on, or beneath the first layer, wherein damage to the interior lumen is detectable based upon damage to the electromagnetic trace.
  • Example 37 is a method of reprocessing an endoscope lumen comprising: cleaning an internal surface of an endoscope lumen; inspecting an interior surface of the lumen using a sensor engageable with the endoscope lumen; producing a sensor signal based on an indicator of the interior surface; detecting a disruption or a lack of disruption in the indicator that indicates whether a compromised state of the internal surface is present.
  • Example 38 the subject matter of Example 37 optionally includes wherein the compromised state indicates presence of at least one of biological material on the interior surface and damage to the interior surface.
  • Example 39 the systems, devices, or methods of any one or any combination of Examples 1 - 38 can optionally be configured such that all elements or options recited are available to use or select from.
  • the terms“a” or“an” are used, as is common in patent documents, to include one or more than one, independent of any other instances or usages of“at least one” or “one or more.”
  • the term“or” is used to refer to a nonexclusive or, such that“A or B” includes“A but not B,”“B but not A,” and“A and B,” unless otherwise indicated.

Abstract

An endoscope lumen can include an elongated body that can include a wall including an interior surface and defining a lumen extending at least partially through the body. The interior surface can form an identifier exposed to the lumen where the identifier can be configured to indicate damage to the interior surface.

Description

IDENTIFIERS IN MEDICAL DEVICE LUMEN
PRIORITY CLAIM
[0001] This application claims priority to and the benefit of U.S Provisional application with serial number 62/755,818, filed on November 5, 2018, entitled IDENTIFIERS IN
MEDICAL DEVICE LUMEN, which is herein incorporated by reference in its entirety.
TECHNICAL FIELD
[0002] Embodiments pertain to the cleaning and reprocessing of reusable medical equipment. More particularly, this disclosure relates to, but not by way of limitation, inspection of endoscopes.
BACKGROUND
[0003] Endoscopes are optical instruments that are insertable into patient cavities for observation of body systems such as joints, the digestive tract, kidneys, and bladders. In some examples, endoscopes provide illumination to enhance optical performance. Endoscopes can be used for diagnostic purposes (e.g., observe tissue; take tissue samples), or therapeutic/treatment purposes (e.g., to remove polyps, remove cancer, introduce drugs, etc.) as the endoscope provides both a visual and operative pathway. After use for inspection or a surgical procedure, an endoscope can be processed for reuse with another patient or procedure.
[0004] Specific de-contamination procedures and protocols are utilized to clean reusable medical equipment. As one example in the medical setting involving reusable medical equipment, endoscopes that are designed for use in multiple procedures must be fully cleaned and reprocessed after a medical imaging procedure to prevent the spread of infectious organisms. Once an endoscope is used in the medical procedure, an endoscope is considered contaminated until it is properly cleaned and disinfected through a series of specific cleaning actions.
[0005] A number of protocols and assisting equipment for cleaning, disinfection, and inspection are used by current medical practices to reprocess endoscopes and prepare them for subsequent procedures. For example, various machines and devices such as automated endoscope reprocessors are used to perform deep cleaning of an endoscope, through the application of disinfecting cleaning solutions. High-level disinfection or sterilization processes are typically performed after manual cleaning to remove remaining amounts of soils and biological materials. However, an endoscope is not considered as ready for high-level disinfection or sterilization until it has been inspected and verified to function correctly, without any damage or leaking parts. If the endoscope includes damaged surfaces, leaks, broken controls, or the like, the endoscope may not be fully exposed to deep cleaning by the disinfecting chemicals, and the opportunity for spreading contamination significantly increases.
[0006] During existing manual cleaning procedures, a human technician may inspect the endoscope for damage and perform various types of inspections, verifications, or tests on the external surfaces and operations components of the endoscope. However, many types of contaminants and damage within the endoscope are not readily visible or observable by a human. Therefore, there is a need to improve cleaning processes of endoscopes to reduce the incidence and amount of residual biological material, as well as a need to improve inspection processes to detect residual biological material or damage to the endoscope.
BRIEF DESCRIPTION OF THE DRAWINGS
[0007] In the drawings, which are not necessarily drawn to scale, like numerals may describe similar components in different views. Like numerals having different letter suffixes may represent different instances of similar components. The drawings illustrate generally, by way of example, but not by way of limitation, various embodiments discussed in the present document.
[0008] FIG. 1 illustrates an overview of devices and systems involved in stages of endoscope use and reprocessing, in accordance with at least one example of the present disclosure.
[0009] FIG. 2 illustrates a schematic cross-section illustration of an endoscope, operated, in accordance with at least one example of the present disclosure.
[0010] FIG. 3 illustrates data flows provided with a cleaning workflow and tracking system, during respective stages of endoscope use and processing, in accordance with at least one example of the present disclosure.
[0011] FIG. 4 illustrates a block diagram of system components used to interface among imaging, tracking, in accordance with at least one example of the present disclosure.
[0012] FIG. 5 illustrates a perspective view of a portion of a borescope within a lumen of an endoscope, in accordance with at least one example of the present disclosure.
[0013] FIG. 6A illustrates a focused perspective view of a portion of a borescope within a lumen of an endoscope, in accordance with at least one example of the present disclosure. [0014] FIG. 6B illustrates a further focused perspective view portion of a portion of a borescope within a lumen of an endoscope, in accordance with at least one example of the present disclosure.
[0015] FIG. 7 A illustrates a focused side view of an internal portion of a lumen of an endoscope, in accordance with at least one example of the present disclosure.
[0016] FIG. 7B illustrates a focused side view of an internal portion of a lumen of an endoscope, in accordance with at least one example of the present disclosure.
[0017] FIG. 7C illustrates a focused side view of an internal portion of a lumen of an endoscope, in accordance with at least one example of the present disclosure.
[0018] FIG. 7D illustrates a focused side view of an internal portion of a lumen of an endoscope, in accordance with at least one example of the present disclosure.
[0019] FIG. 8A illustrates a cross-section view of a lumen of an endoscope, in accordance with at least one example of the present disclosure.
[0020] FIG. 8B illustrates a focused cross-section view of a lumen of an endoscope, in accordance with at least one example of the present disclosure.
[0021] FIG. 9 illustrates a block diagram of architecture for an example computing system used, according to at least one example of the present disclosure.
[0022] FIG. 10 illustrates a schematic view of a method, in accordance with at least one example of the present disclosure.
[0023] FIG. 11 illustrates a schematic view of a method, in accordance with at least one example of the present disclosure.
[0024] FIG. 12 illustrates a schematic view of a method, in accordance with at least one example of the present disclosure.
DETAILED DESCRIPTION
[0025] The following description and the drawings sufficiently illustrate specific embodiments to enable those skilled in the art to practice them. Other embodiments may incorporate structural, logical, electrical, process, and other changes. Portions and features of some embodiments may be included in, or substituted for, those of other embodiments.
Embodiments set forth in the claims encompass all available equivalents of those claims. [0026] A major problem in reprocessing of endoscopes is the cleaning of the lumens in the endoscope, specifically the suction and biopsy channel. These lumens can easily become damaged or covered in biofilm. Relatively recent industry standards recommend that endoscope channels be visually inspected to determine if they are damaged or they contain biofilm or other organic material. Such inspection can be difficult and may require special borescopes that can look down the small channels. Even with the use of a borescope, it can be difficult to determine if a scope channel is damaged.
[0027] This disclosure addresses these issues by creating a suction / biopsy channel that contains a predefined pattern on the internal surface of the lumen. Such a pattern can be detected by a visualization system. In some examples, a pattern, indicator, or identifier can be applied to a specific depth of the lumen, enabling automated inspection to determine if the lumen had been damaged, to measure the depth of the damage, and to detect if a biofilm is or was coating a portion of the lumen.
[0028] This foregoing discussion is intended to provide an overview of subject matter of the present patent application. It is not intended to provide an exclusive or exhaustive explanation of the invention. The discussion below is included to provide further information about the present patent application.
[0029] FIG. 1 illustrates an overview of devices and systems involved in example stages of endoscope use and reprocessing. In the environment illustrated in FIG. 1, a series of stages are sequentially depicted for use and handling of the endoscope, transitioning from a procedure use stage 110, to manual reprocessing stage 120, to an automated reprocessing stage 140, to a storage stage 150. It will be understood that the stages 110, 120, 140, 150 as depicted and described provide a simplified illustration of typical scenarios in the use, handling, and reprocessing for reusable endoscopes. As a result, many additional steps and the use of additional devices and procedures (or, substitute procedures and substitute devices) may be involved in the respective stages.
[0030] The procedure use stage 110 depicts a human user 112 (e.g., technician, nurse, physician, etc.) who handles an endoscope. At the commencing of the procedure use stage 110, the endoscope 116A is obtained in a high level disinfected (HFD) or sterile/clean state. This disinfected/clean state typically results from reprocessing and storage of the endoscope 116A, although the state may also be provided from a disinfected repair or factory-provided state (not shown). In the procedure use stage 110, the endoscope 116A may be used for various endoscopic procedures (e.g., colonoscopy, upper endoscopy, etc.) on a subject human patient, for any number of diagnostic or therapeutic purposes. During the endoscopic procedures, the endoscope 116A is exposed to biological material from the subject patient or the surrounding environment. Thus, at the completion of the procedure use stage 110, the endoscope 116A exists in a contaminated state.
[0031] The disinfected or contamination state of the endoscope 116A may be tracked by a tracking system for purposes of monitoring, auditing, and other aspects of workflow control. An interface 114 to the tracking system is shown, which receives an identifier of the endoscope 116A and provides a graphical status as output. The tracking system may be used in the procedure use stage 110 (and the other stages 120, 140, 150) to identify the use of the endoscope 116A to be associated with a particular imaging procedure, patient, procedure equipment, procedure room, preparation or cleaning protocol, or other equipment or activities. This identifying information may enable the tracking system to track the contamination or disinfected state of the endoscope, and to identify and prevent exposure of contamination or infectious agents to patients or handling personnel from damaged endoscopes or improper cleaning procedures.
[0032] After the procedure use stage 110, the endoscope transitions to handling in a manual reprocessing stage 120. The manual reprocessing stage 120 specifically depicts the use of manual cleaning activities being performed by a technician 122, to clean the endoscope 116B. The type of manual cleaning activities may include use of disassembly and removal of components, applying brushes to clear channels, wiping to remove visible liquids and solids, and other human-performed cleaning actions. Some of the manual cleaning activities may occur according to a regulated sequence or manufacturer-specified instructions.
[0033] The manual reprocessing stage 120 also depicts the use of a flushing aid device 128 and a borescope 126 to conduct additional aspects of cleaning and inspection. In an example, the flushing aid device 128 serves to perform an initial chemical flush of the internal channels of the endoscope 116B (e.g., water, air, or suction channels) with cleaning agents. The flushing aid device 128 may also enable the performance of leak testing, to verify whether components or structures of the endoscope leak fluid (e.g., leak water or air). In other examples, the flushing or leak test actions performed by the flushing aid device 128 are manually performed by the syringing of chemicals or air into the endoscope channels. The results of the leak testing and the flushing may be tracked or managed as part of a device tracking or cleaning workflow.
[0034] In an example, the borescope 126 is used as part of an inspection process, such as to inspect an interior lumen of a channel in the endoscope 116B. This may include the inspection of a channel of the endoscope 116B used for biopsy and instrument insertion. The borescope 126 be inserted and advanced by a human or a machine within one or more lumens of the endoscope 116B to perform the inspection process. This inspection process may occur before or after the performance of the leak test, flushing, or other cleaning or testing activities in the manual reprocessing stage 120.
[0035] The borescope 126 may produce image data 132 (e.g., one or more images, such as a video) that provides a detailed, high-resolution view of the status of a channel of the endoscope 116B. The image data 132 may be provided to a computing system 130 for processing and analysis. The borescope 126 may be operated as part of a borescope inspection system, which provides controlled or mechanicalized advancement and movement of the borescope 126 within an inspection procedure. The results of the borescope inspection procedure may be tracked or managed as part of a device tracking or cleaning workflow, including with the aforementioned tracking system.
[0036] In an example, the computing system 130 is provided by a visual inspection processing system that uses a trained artificial intelligence (e.g., machine learning) model to analyze image data 132 and identify a state of the endoscope channel. For instance, the state of the endoscope channel may include, no detected abnormalities (e.g., an integrity state), or a detected presence of biological material or a detected presence of channel damage (e.g., a compromised state). Further examples of the borescope inspection system and the visual inspection processing system are provided in the discussed examples below.
[0037] After completion of the manual reprocessing stage 120, the endoscope is handled in an automated reprocessing stage 140. This may include the use of an automatic endoscope reprocessor (AER) 142, or other machines which provide a high-level disinfection and sterilization of the endoscope. For instance, the AER 142 may perform disinfection for a period of time (e.g., for a period of minutes) to expose the interior channels and exterior surfaces of the endoscope to deep chemical cleaning and disinfectant solutions. The AER 142 may also perform rinsing procedures with clean water to remove chemical residues. [0038] After completion of the automated reprocessing stage 140 and the production of the endoscope in a disinfected state, the endoscope transitions to handling in a storage stage 150.
This may include the storage of the endoscope in a sterile storage unit 152. In some examples, this stage may also include the temporary storage of the endoscope in a drying unit. Finally, retrieval of the endoscope from the storage stage 150 for use in a procedure results in
transitioning back to the procedure use stage 110.
[0039] The overall cleaning workflow provided for an endoscope within the various reprocessing stages 120 and 140 may vary according to the specific type of device, device specific requirements and components, regulations, and the types of cleaning chemicals and devices applied. However, the overall device use and cleaning workflow, relative to stages of contamination, may be generally summarized in stages 110, 120, 140, 150, as involving the following steps:
[0040] 1) Performance of the endoscopic procedure. As will be well understood, the endoscopic procedure results in the highest amount of contamination, as measured by the amount of microbes contaminating the endoscope.
[0041] 2) Bedside or other initial post-procedure cleaning. This cleaning procedure removes or reduces the soils and biological material encountered on the endoscope during the endoscopic procedure. As a result, the amount of contamination, as measured by the amount of microbes, is reduced.
[0042] 3) Transport to reprocessing. The more time that is spent between the procedure and reprocessing results in a potential increase in the amount of contamination or difficulty to remove the contamination, due to biological materials drying, congealing, growing, etc.
[0043] 4) Performance of a leak test (e.g., conducted in the manual reprocessing stage 140 with the flushing aid device 128 or a standalone leak testing device or procedure (not shown)). This leak test is used to verify if any leaks exist within channels, seals, controls, valve housings, or other components of the endoscope. If the endoscope fails the leak test, or encounters a blockage during flushing, then high-level disinfection or sterilization attempted in automated reprocessing will be unable to fully flush and disinfect all areas of the endoscope. Further, if the leak test fails but the instrument is placed in an automatic reprocessing machine, the instrument will be damaged through fluid ingress during the reprocessing cycle. [0044] 5) Manual washing (e.g., conducted in the manual reprocessing stage 140 with brushes, flushing, etc.). This aspect of manual washing is particularly important to remove biofilm and lodged biological agents from spaces on or within the endoscope. Biofilm generally refers to a group of microorganisms that adheres to a surface, which may become resistant or impervious to cleaning and disinfectant solutions. The successful application of manual washing significantly reduces the amount of contamination on the endoscope.
[0045] 6) Damage inspection (e.g., conducted in manual reprocessing stage 140 with a borescope inspection system). Microbes and in particular biofilm may resist cleaning if lodged in damaged or irregular portions of the endoscope. A procedure of damage inspection can be used to identify surface irregularities, scratches and fissures, or other defects or abnormal states (e.g., a compromised state) within the interior channels, exterior surfaces, or components of the endoscope. This damage inspection may also be accompanied by the detection of biological materials (such as biofilms) which remain after manual washing. Such damage inspection may be performed with use of a borescope inspection system, visual inspection system, and other mechanisms discussed herein.
[0046] 7) High level disinfection or sterilization (e.g., conducted in AER 142). Upon successful conclusion of the high-level disinfection or sterilization process, in an ideal state for an endoscope with no damage, no biological contamination will remain from the original endoscopic procedure.
[0047] 8) Rinse and Air Purge. This stage involves the introduction of clean water and air, to flush any remaining chemical solution and to place the endoscope in a disinfected and clean state. The risk of introducing new contamination may be present if contaminated water or air are introduced to the endoscope.
[0048] 9) Transport to Storage. This stage involves the transport from the AER or other device to storage. A risk of introducing new contamination may be present based on the method and environment of transport and handling.
[0049] 10) Storage. This stage involves the storage of the endoscope until needed for a procedure. A risk of introducing new contamination may be present based on the conditions in the storage unit. [0050] 11) Transport to Patient. Finally, the endoscope is transported for use in a procedure.
A risk of introducing new contamination may also be present based on the method and environment of transport and handling.
[0051] Further aspects which may affect contamination may involve the management of valves and tubing used with a patient. For instance, the use of reusable valves, tubing, or water bottles in the procedure may re-introduce contamination to the endoscope. Accordingly, the disinfected state of a processed endoscope can only be provided in connection with the use of other disinfected equipment and proper handling in a clean environment.
[0052] FIG. 2 is a schematic cross-section illustration of an endoscope 200, operable according to various examples. The endoscope 200 as depicted includes portions that are generally divided into a control section 202, an insertion tube 204, a universal cord 206, and a light guide section 208. A number of imaging, light, and stiffness components and related wires and controls used in endoscopes are not depicted for simplicity. Rather, FIG. 2 is intended to provide a simplified illustration of the channels important for endoscope cleaning workflows. It will be understood that the presently discussed endoscope cleaning workflows will be applicable to other form factors and designs of endoscopes. The inventive aspects discussed herein can also be utilized for inspection operations on other instruments that include lumens that can become contaminated or damaged during use.
[0053] The control section 202 hosts a number of controls used to actuate the positioning, shape, and behavior of the endoscope 200. For instance, if the insertion tube 204 is flexible, the control section 202 may enable the operator to flex the insertion tube 204 based on patient anatomy and the endoscopic procedure. The control section 202 also includes a suction valve 210 allowing the operator to controllably apply suction at a nozzle 220 via a suction channel 230. The control section 202 also includes an air/water valve 212 which allows the distribution of air and/or water from an air channel 232 (provided from an air pipe source 218) or a water channel 228 (provided from a water source connected to a water source connector 224) to the nozzle 220. The depicted design of the endoscope 200 also includes a water jet connector 222 via a water-jet channel 226, to provide additional distribution of water separate from the air channel 232.
[0054] The universal cord 206 (also known as an“umbilical cable”) connects the light guide section 208 to the control section 202 of the endoscope. The light guide section 208 provides a source of light which is distributed to the end of the insertion tube 204 using a fiber optic cable or other light guides. The imaging element (e.g. camera) used for capturing imaging data may be located at in the light guide section 208 or adjacent to the nozzle 220.
[0055] As shown, the various channels of the endoscope 200 allow the passage of fluids and objects, which may result in the contamination throughout the extent of the channels. The portion of the suction channel 230 which extends from the biopsy valve 214 to the distal end of the insertion tube 204 (to the nozzle 220) is also known as the biopsy channel. In particular, the biopsy channel, and the remainder of the suction channel 230, is subject to a high likelihood of contamination and/or damage in the course of an endoscopic procedure. For example, the insertion, manipulation, and extraction of instruments (and biological material attached to such instruments) through the suction channel 230 commonly leads to the placement of microbes within the suction channel 230.
[0056] Any damage to the interior layer(s) of the biopsy channel, such as in scratches, nicks, or other depressions or cavities to the interior surface caused by instruments moving therein may also lead to deposits of biological material. Such biological material which remains in cavities, or which congeals in the form of biofilm, may be resistant to many manual cleaning techniques such as brushes pulled through the suction channel. Such damage may also occur in the other channels 228, 230, 232, as a result of usage, deterioration, or failure of components. The techniques discussed herein provide enhanced techniques in connection with the inspection and verification of the integrity of the channels 228, 230, 232, including integrity from damages or defects, and/or integrity from deposited biological materials and contamination.
[0057] FIG. 3 illustrates data flows 300 provided with an example cleaning workflow and tracking system 380, during respective stages of endoscope use and processing, including the use of a borescope inspection system 350 and visual inspection processing system 360 used to perform an integrity verification of one or more endoscope channels.
[0058] The data flows 300 specifically illustrate the generation and communication of data as an endoscope is handled or used at various locations. These include: status of the endoscope at a storage facility 310 (e.g., the storage unit 152 in the storage stage 150), as indicated via status data (e.g., a location and sterilization status of the endoscope); status of the use of the endoscope at a procedure station 320 (e.g., as handled in the procedure use stage 110), as indicated via procedure data (e.g., an identification of a patient, physician, and handling details during the procedure); status of the testing of the endoscope at a testing station 330 (e.g., at a leak or component test device), as indicated via test result data (e.g., a pass or fail status of a test, measurement values, etc.); status of the manual cleaning actions performed at a manual cleaning station 340 (e.g., as performed by the technician 122), as indicated by inspection data (e.g., a status that logs the timing and result of inspection procedures, cleaning activities); and a status of the machine cleaning actions performed at an automated cleaning station 370 (e.g., as performed by the AER 124), as indicated by cleaning result data (e.g., a status that logs the procedures, chemicals, timing of automated reprocessing activities). Such statuses and data may be communicated for storage, tracking, maintenance, and processing, at a cleaning workflow and tracking system 380 (and databases operated with the system 380).
[0059] The location of the endoscope among the stations, and activities performed with the endoscope, may be performed in connection with specific device handling workflow. Such a workflow may include a step-by-step cleaning procedure, maintenance procedures, or a tracking workflow, to track and manage a disinfected or contaminated status, operational or integrity status, or cleaning procedure status of the endoscope components or related equipment. In connection with cleaning operations at the manual cleaning station 340 or the automated cleaning station 370, the subject endoscope may be identified using a tracking identifier unique to the endoscope, such as a barcode, RFID tag, or other identifier coupled to or communicated from the endoscope. For instance, the manual cleaning station 340 and automated cleaning station 370 may host an identifier detector to receive identification of the particular endoscope being cleaned at the respective cleaning station. In an example, the identifier detector comprises a RFID interrogator or bar code reader used to perform hands-free identification.
[0060] Additionally, in connection with a cleaning workflow, tracking workflow, or other suitable device handling workflow, a user interface may be output to a human user via a user interface device (e.g., a display screen, audio device, or combination). For example, the user interface may request input from the human user to verify whether a particular cleaning protocol has been followed by the human user at each of the testing station 330, manual cleaning station 340 and automated cleaning station 370. A user interface may also output or receive
modification of the status in connection with actions at the storage facility 310 and the procedure station 320. The input to such user interface may include any number of touch or touch-free (e.g., gesture, audio command, visual recognition) inputs, such as with the use of touchless inputs to prevent contamination with an input device. [0061] In various examples, input recognition used for control or identification purposes may be provided within logic or devices of any of the stations 310, 320, 330, 340, 370, or as interfaces or controls to the borescope inspection system 350 or the visual inspection processing system 360. In still further examples, tracking of patients, cleaning personnel, technicians, and users or handlers of the endoscope may be tracked within the data values communicated to the cleaning workflow and tracking system 380. The interaction with the cleaning workflow and tracking system 380 may also include authentication and logging of user identification information, including validation of authorized users to handle the device, or aspects of user- secure processing.
[0062] A variety of inquiries, prompts, or collections of data may occur at various points in a device cleaning or handling workflow, managed by the cleaning workflow and tracking system 380, to collect and output relevant data. Such data may be managed for procedure validation or quality assurance purposes, for example, to obtain human verification that a cleaning process has followed proper protocols, or that human oversight of the cleaning process has resulted in a satisfactory result. Workflow steps may also be required by the workflow and tracking system 380 to be performed in a determined order to ensure proper cleaning, and user inquiries and prompts may be presented in a determined order to collect full information regarding compliance or procedure activities.
[0063] Further, the cleaning workflow and tracking system 380 may be used to generate an alert or display appropriate prompts or information if a user or device does not fully complete certain steps or procedures. For example, a status of the lumen inspection can be traced using the cleaning workflow and tracking system 380. In some of these examples, whether the lumen of the catheter is or is not compromised can be determined using the cleaning workflow and tracking system 380 and the devices, systems and methods discussed below with reference to FIGS. 5-12.
[0064] FIG. 4 is a block diagram of system components used to interface among example imaging, tracking, and processing systems. As shown, the components of the borescope inspection system 350 may include a borescope imaging device 352, which is operably coupled to a movement control device 354. The borescope inspection system 350 may provide video or imaging output in connection with imaging of internal channels of the endoscope 410. The use of the borescope inspection system 350 may be tracked and managed as part of an inspection procedure in a cleaning workflow, with resulting tracking and inspection data facilitated by the cleaning workflow and tracking system 380.
[0065] The cleaning workflow and tracking system 380 may include functionality and processing components used in connection with a variety of cleaning and tracking purposes involving the endoscope 410. Such components may include device status tracking management functionality 422 that utilizes a device tracking database 426 to manage data related to status(es) of contamination, damage, tests, and usage for the endoscope 410 (e.g., among any of the stages 110, 120, 140, 150). Such components may also include a device cleaning workflow
management functionality 424 used to track cleaning, testing, verification activities, initiated as part of a cleaning workflow for the endoscope 410 (e.g., among the reprocessing stages 120,
140). As specific examples, the workflow management database 428 may log the timing and performance of specific manual or automatic cleaning actions, the particular amount or type of cleaning or disinfectant solution applied, which user performed the cleaning action, and the like.
[0066] The data and workflow actions in the cleaning workflow and tracking system 380 may be accessed (e.g., viewed, updated, input, or output) through use of a user computing system 430, such as with an input device 432 and output device 434 of a personal computer, tablet, workstation, or smartphone, operated by an authorized user. The user computing system 430 may include a graphical user interface 436 to allow access to the data and workflow actions before, during, or after any of the handling or cleaning stages for the endoscope 410 (e.g., among any of the stages 110, 120, 140, 150). For instance, the user computing system 430 may display a real time status of whether the endoscope 410 is disinfected, which tests have been completed and passed during cleaning, and the like.
[0067] The visual inspection processing system 360 is shown as also including functionality and processing components used in connection with analysis of data from the borescope inspection system 350, and/or the cleaning workflow and tracking system 380. For instance, video captured by a borescope imaging device 352, advanced within a channel of the endoscope 410 at a particular rate by the movement control device 354, may be captured in real-time through use of inspection video capture processing 362. The respective images or video sequences captured are subjected to image pre-processing 364, such as to enhance, crop, or modify images from the borescope imaging device 352. Finally, respective images or sequences of images are input into an image recognition model 366 for computer analysis of the integrity state of the captured channel. The visual inspection processing performed by the processing system 360 may occur in real time with coordinated use (and potentially, automated or machine- assisted control) of the borescope inspection system 350, or as part of a subsequently performed inspection procedure.
[0068] In an example, the image recognition model 366 may be a machine-learning image classifier which is trained to identify normal (full integrity) conditions of an imaged channel lumen, versus abnormal (compromised integrity) conditions of the imaged channel lumen. Such abnormal conditions may include the existence of damage or defects to the lumen, the deposit of biological material on the lumen, etc. Other types and forms of artificial intelligence processing may also be used in combination with the image recognition model 366. The results (e.g., classification or other data outputs) from the image recognition model 366 may be output via the user computing system 430, or recorded in the cleaning workflow and tracking system 380.
[0069] FIG. 5 illustrates a perspective view of a portion of a borescope 502 within a lumen 504 of an endoscope (such as endoscope 200 of FIG. 2), in accordance with at least one example of the present disclosure. The lumen 504 can include a body 506, a wall 508, a lumen 510, and an internal surface 512. FIG. 5 also shows a directional arrow A, cross-section indicators 6-6, and orientation indicators Proximal and Distal. The lumen 504 can include a pattern or identifier on an internal surface of a wall of the lumen, where the pattern can enable detection of a compromised state of the lumen (or a lack of compromise to the lumen). Any of the previously discussed lumens or channels can be modified to include such a pattern.
[0070] The lumen 504 can be a relatively small tube or cylindrical member configured to receive a borescope and other tools therethrough, such as forceps, snares, retractors, scalpels, or the like. In some examples, the lumen 504 can be one of the channels 226, 228, 230, and 232 discussed above with respect to the endoscope 200 of FIG. 2. The body 506 can be a rigid or semi-rigid body comprised of materials such as metals, plastics, foams, elastomers, ceramics, composites, and combinations thereof. In some examples, the body 506 can be relatively flexible for navigation through curved pathways within cavities and organs of a human body. The wall 508 can be a circumferential wall of the body 506 and can define one or more lumens therein, such as the lumen 510. In some examples, the wall can include multiple layers, as discussed below. The wall 508 can include the internal surface 512, which can be made of one or more materials and one or more patterns, as discussed below in further detail. [0071] In operation of some examples, the borescope 502 can be inserted into (for example) a proximal end of the body 506 and into the lumen 510 in direction A. The borescope 502 can be used to inspect the internal surface 512 of the body 506. During inspection, the borescope 502 can be advanced by a human or a machine within the lumen 510. As discussed with respect to previous examples, the borescope 502 may produce image data (such as image data 132) that can be used to provide a detailed, high-resolution view of the status of the internal surface 512 of the lumen 510. The image data may be provided to a computing system (such as the computing system 130) for processing and analysis. The results of the borescope inspection procedure may be tracked or managed as part of a device tracking or cleaning workflow, including with the aforementioned tracking system.
[0072] As discussed in further detail below, the internal surface 512 may include an identifier, such as a pattern, detectable by the borescope and indicated by a display (and/or a computing system). For example, a computing system can analyze data received from the borescope to detect a compromised state (or a lack of a compromised state) of the inner surface 512 of the wall 508. Such a compromised state can be damage to or a biological deposit on the inner surface 512.
[0073] FIG. 6A illustrates a focused perspective view of a portion of the borescope 502 within the lumen 504 of an endoscope across indicators 6-6 of FIG. 5, in accordance with at least one example of the present disclosure. FIG. 6B illustrates a further focused perspective view of a portion of the borescope 502 within the lumen 504 of an endoscope as indicated by 6B of FIG. 6A, in accordance with at least one example of the present disclosure. FIGS. 6A and 6B are discussed below concurrently. The borescope 502 and the lumen 510 can be consistent with those of FIG. 5, except that FIGS. 6A and 6B show additional details of the lumen 504 and the lumen 510, such as the internal surface 512 of the wall 508 of the lumen 504.
[0074] The borescope 502 can include an optical portion 514 (which can have a detection range 516). The lumen 504 can include the body 506, the wall 508, the lumen 510, and the internal surface 512. The wall 508 of the lumen 504 can also include indicators 520A-520C (collectively referred to as the identifier 520). Also shown are damage 522 and a biological deposit 524. FIG. 6A also shows a view indicator 6B, section indicators 7-7, and orientation indicators Proximal and Distal. [0075] The optical portion 514 of the borescope can include a lens or focusing mechanism that can determine the detection range 516. In some examples, the detection range can be longer and/or wider (radially). In some examples, the optical portion 514 can further include a light source for illuminating the inner surface 512 of the wall 508. In still further examples, the optical portion 514 can include a video recording device for producing and/or storing image data.
[0076] The identifier 520 can be a pattern on and/or a layer in the inner surface 512 of the wall 508. In some examples, the identifier 520 can be a variation in color or texture from the inner surface 512. In other examples, the identifier 520 can be an electrical or magnetic component. In the example shown in FIGS. 6A and 6B, the identifier 520 can be an arrangement of circles or cylinders extending around an inner circumference (of the inner surface 512) of the wall 508 where the individual identifiers (such as identifiers 520A, 520B, and 520C) are equally spaced from each other along an axial length of the wall 508.
[0077] Also shown in FIGS. 6A and 6B are the damage 522 and the biological deposit 524. The damage 522 can be a rip, tear, cut, protrusion, abrasion, fissure, hole or other imperfection or damage to the internal surface 512. The biological deposit 524 can be a foreign object of biological matter such as (generally) soil, biofilm, tissue, other bodily fluids or solids, or the like. In some examples, as shown in FIGS. 6A and 6B the damage 522 and the biological deposit can be small relative to the size of the lumen 504, which can be a relatively small device. This can make detection of such damage and/or biological deposits difficult using the human eye or through image processing software through a visual inspection processing system, such as system 360 of FIG. 4.
[0078] In operation of some examples of using, for example, the borescope inspection system 350 and visual inspection processing system 360 of FIG. 4, the borescope 502 can be passed through the lumen 510 for inspection of the inner surface 512 of the wall 508. During inspection, as shown in FIG. 6B, the optical portion 514 of the borescope 502 can view the inner surface 512 over the detection range 516. Because the inner surface 512 can include identifiers 520A-520C, the visual inspection processing system 360 can determine whether or not the internal surface 512 is in a compromised state. That is, whether the internal surface 512 is damaged and/or whether the internal surface contains any biological matter.
[0079] When the identifier (or the pattern of the identifier) 520 is unbroken, the visual inspection processing system 360 can determine that the internal surface is not in a compromised state. When the identifier 520 is interrupted, such as by the damage 522 and the biological deposit 524, the optical portion 514 of the visual inspection processing system 360 can determine that the internal surface 512 is in a compromised state. More specifically, the damage 522 interrupts the identifiers 520B and 520C by physically breaking the lines or cylinder shapes of the identifiers 520B and 520C. The optical portion 514 can detect such a break in the continuity of the identifier 520 and can provide a signal to another system or operator which can analyze the signal or a visual representation thereof to determine that a compromised state exists.
[0080] Similarly, by covering one or more of the identifiers 520, the biological deposit 524 can disrupt the pattern of the identifier 520. As shown in FIGS. 6A and 6B, the biological deposit 524 can partially cover the identifiers 520A, 520B, and 520C. When the optical portion 514 approaches the biological deposit 524, the visual inspection processing system 360 can detect the disruption in the identifier 520, and can determine that the internal surface 512 is in a
compromised state. By providing an ability to produce an indication to another system or operator that a compromised state exists, the lumen 504 can help reduce inspection time during reprocessing of endoscopes, can help prevent equipment failures from missed damage to the internal surface, and can help to prevent transmission of biological material between patients and procedures. In this way, the lumen 504 can enable detection of a compromised state despite the damage or biological deposit being relatively small.
[0081] FIG. 7A illustrates a focused side view of an internal portion 702 of a lumen 700 of an endoscope, in accordance with at least one example of the present disclosure. The lumen 700 can include a square array pattern or identifier on an internal surface of a wall of the lumen, where the pattern can enable detection of a compromised state of the lumen (and/or the lack of damage or compromise to the lumen). Any of the previously discussed lumens or channels can be modified to include such a pattern.
[0082] The lumen 700 can include the internal portion 702, a wall 704, an internal surface 706, horizontal identifiers 708A-708N, and vertical identifiers 710A-710N. Also shown in FIG. 7A is axis A.
[0083] The lumen 700 can be similar to the lumen 504 of FIGS. 5-6B except that the lumen 700 can include horizontal and vertical identifiers that can form a square or grid pattern in and/or on the surface 706 of the lumen 700. That is horizontal identifiers 708A-708N can be substantially parallel with axis A and vertical identifiers 710A-710N can be at angle of substantially 90 degrees with respect to axis A and to the horizontal identifiers 708A-708N.
[0084] The horizontal identifiers 708A-708N can extend along a length of the internal surface 706 of the lumen 700 and can be substantially equally spaced around a circumference of the inner surface 706 of the lumen 700, in some examples. In other examples, the horizontal identifiers 708A-708N can be unevenly spaced, for example, to provide an indication of position or orientation of the optical device, or to provide a location (along a length, for example) of the optical device within the lumen 700. The number of horizontal identifiers 708A-708N can be 1,
2, 3, 4, 5, 6, 7, 8, 9, 10, 15, 20, 30, 40, or the like.
[0085] The vertical identifiers 710A-710N can each extend around an inner circumference of the internal surface 706 of the lumen 700 and can be substantially equally spaced, in some examples, along a length of the lumen 700. In other examples, the vertical identifiers 710A-710N can be unevenly spaced, for example, to provide an indication of position or orientation of the optical device, or to provide a location (along a length, for example) of the optical device within the lumen 700. The number of vertical identifiers 710A-710N can be 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 15, 20, 30, 40, or the like. Further, by varying the number or spacing of either of the horizontal identifiers 708A-708N or the vertical identifiers 710A-710N, the indication patter of the lumen 700 can be rectangular grid.
[0086] Together, the horizontal identifiers 708A-708N and the vertical identifiers 710A- 710N can form a substantially square grid pattern or array, which can help to determine whether or not a compromised state or condition of the internal surface 706 (such as damage or a biofilm) is present. By including identifiers in substantially opposing directions, the identifiers 708 and 710 can help to increase the accuracy of the determination of whether a compromised state exists in the lumen 700, helping to improve reprocessing speed and completeness.
[0087] Though the embodiment of FIG. 7A is discussed with respect to vertical and horizontal identifiers, the identifiers may not be strictly vertical or horizontal, and may be angled with respect to an axis of the lumen. That is, horizontal identifiers 708A-708N can be non parallel with axis A. Also, vertical identifiers 710A-710N can be at angles other than 90 degrees with respect to axis A, such as 60, 65, 70, 75, 80, 85, 95, 100, 105, 110, 115, and 120 degrees, or the like. [0088] FIG. 7B illustrates a focused side view of an internal portion 802 of a lumen 800 of an endoscope, in accordance with at least one example of the present disclosure. The lumen 800 can include a hexagonal array pattern or identifier on an internal surface of a wall of the lumen 800, where the pattern can enable detection of a compromised state of the lumen 800 (and/or the lack of damage or compromise to the lumen). Any of the previously discussed lumens or channels can be modified to include such a pattern.
[0089] The lumen 800 can include the internal portion 802, a wall 804, an internal surface 806, horizontal identifiers 808A-808N, first diagonal identifiers 810A-810N, second diagonal identifiers 812A-812N, and hexagons 814A-814N. Also shown in FIG. 7B is axis A.
[0090] The lumen 800 can be similar to the lumen 504 of FIGS. 5-6B and the lumen 700 of FIG. 7A, except that the lumen 800 can include horizontal, first diagonal, and second diagonal identifiers that can form a hexagonal grid pattern in and/or on the surface 806 of the lumen 800. That is, horizontal identifiers 808A-808N can be substantially parallel with axis A, first diagonal identifiers 810A-810N can be at angle of substantially 120 degrees with respect to axis A, and second diagonal identifiers 812A-812N can be at angle of substantially 60 degrees with respect to axis A
[0091] The horizontal identifiers 808A-808N can extend in segments along a length of the internal surface 806 of the lumen 800 and can be substantially equally spaced around a circumference and along the axis A of the inner surface 806 of the lumen 800, in some examples. In other examples, the horizontal identifiers 808A-808N can be unevenly spaced, for example, to provide an indication of position or orientation of the optical device, or to provide a location (along a length, for example) of the optical device within the lumen 800. The number of horizontal identifiers 808A-808N per centimeter of length can be 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 15, 20, 30, 40, or the like.
[0092] The first diagonal identifiers 810A-810N can each extend around an inner
circumference of the internal surface 806 of the lumen 800 in segments and can be substantially equally spaced, in some examples. In other examples, the first diagonal identifiers 810A-810N can be unevenly spaced, as described above with respect to other identifiers. The number of first diagonal identifiers 810A-810N per centimeter of length can be 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 15, 20, 30, 40, or the like. Similarly, the second diagonal identifiers 812-812N can each extend around an inner circumference of the internal surface 806 of the lumen 800 in segments and can be substantially equally spaced, in some examples. In other examples, the second diagonal identifiers 812A-812N can be unevenly spaced, as described above with respect to other identifiers. The number of second diagonal identifiers 812A-812N per centimeter of length can be 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 15, 20, 30, 40, or the like.
[0093] Together, the horizontal identifiers 808A-808N, the first diagonal identifiers 810A- 810N, and the second diagonal identifiers 812A-812N can form the hexagons 814A-814N. In some examples, each of the hexagons 814A-814N can be regular hexagons. In other examples, by varying the number or spacing of any of the horizontal identifiers 808A-808N, the first diagonal identifiers 810A-810N, and/or the second diagonal identifiers 812A-812N, as discussed above, the indication pattern of the lumen 800 can be an irregular hexagonal grid. In further examples, vertical identifiers can be incorporated to create an octagonal grid or pattern. In other examples, various other geometric grids can be used.
[0094] In operation of some examples, the hexagonal grid pattern or array can help to determine whether or not a compromised state or condition of the internal surface 806 (such as damage or a biofilm) is present. By including identifiers in various directions, the identifiers 808, 810, and 812 can help to increase the accuracy of the determination of whether a compromised state exists in the lumen, helping to improve reprocessing speed and completeness.
[0095] FIG. 7C illustrates a focused side view of an internal portion 902 of a lumen 900 of an endoscope, in accordance with at least one example of the present disclosure. The lumen 900 can include a rifled or helical array pattern or identifier on an internal surface of a wall of the lumen. Such a pattern can enable detection of a compromised state of the lumen 900 (and/or the lack of damage or compromise to the lumen). Any of the previously discussed lumens or channels can be modified to include a rifled or helical pattern.
[0096] The lumen 900 can include the internal portion 902, a wall 904, an internal surface 906, helical identifiers 908A-908N, a control device 910, and a connector 912. Also shown in FIG. 8 is axis A.
[0097] The lumen 900 can be similar to the lumen 504 of FIGS. 5-6B, the lumen 700 of FIG. 7 A, and the lumen 800 of FIG. 7B, except that the lumen 900 can include helical identifiers that can form a single identifier within the lumen 900. That is, the helical identifiers 908A-908N can extend around a circumference of the internal surface 906 of the lumen 900 and extend along an axial length of the lumen such that the helical identifiers 908A-908N form a rifle pattern or helical pattern of a single identifier within internal portion 902 about axis A.
[0098] In some examples, the helical identifiers 908A-908N can be substantially equally spaced around a circumference and along the axis A of the inner surface 906 of the lumen 800.
In other examples, the helical identifiers 908A-908N can be unevenly spaced, for example, to provide an indication of position or orientation of the optical device, or to provide a location (along a length, for example) of the optical device within the lumen 800. The number of helical identifiers 908A-908N per centimeter can be 0.25, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 15, 20, 30, 40, or the like.
[0099] As discussed above, together, the helical identifiers 908A-908N can form a continuous helix or rifle around the internal surface 906 of the lumen 900, meaning that the helical identifier 908 can be a single identifier or component. In some examples, the single component can be a printed pattern or layer. In other examples, the single component can be an electrical trace on the internal surface 906 or embedded in the wall 904 of the lumen 900. the latter example, the identifier 908 can be connected to the control device 910 via the connector 912.
[0100] In some examples, the control device 910 can connect to the visual processing system 360, the cleaning workflow and tracking system 380, and/or the user computing system 430 of FIG. 4. One or more of such a system can be used to supply a signal, (e.g., a control-level voltage or current) to the identifier 908 and can be used to analyze a signal returned by the identifier 908. Analysis of the returned signal can indicate a compromised state of the internal surface 906, such as damage or a biological deposit. For example, a voltage or current indicating that the identifier 908 (or circuit created thereby) is open can be used to determine that damage exists within the lumen 900. Similarly, a voltage or current indicating that the identifier 908 (or circuit created thereby) is shorted can indicate that a biological deposit exists and is bridging one or more of the helical identifiers 908A-908N.
[0101] In another example where the control device 910 is connected to the visual processing system 360, the cleaning workflow and tracking system 380, and/or the user computing system 430 of FIG. 4, the helical identifier can be a permanent magnetic or electromagnetic component. In some examples, the electromagnetic signal can include a magnetic field and the damaged portion can be identified by sensing an induced electromagnetic response to the delivered magnetic field. In such an example, a magnetic or electromagnetic signature or signal of the helical identifier can be analyzed using a sensor inserted into and/or passed over the lumen.
[0102] Irregularities to, or variances in, the signature and/or signal can indicate a
compromised state of the internal surface 906, such as damage or a biological deposit. In these ways, a single, continuous helical identifier can help to provide a second method of detecting a compromised state (in addition to optical detection) of the internal surface 906 of the lumen 900, which can help improve reprocessing quality and efficiency.
[0103] In another example, where the helical identifiers 908A-908N are electrical traces, the control device 910 can analyze an electrical signature of the electrical traces (of the helical identifiers 908A-908N). In some examples, the electrical signature can be one or more of a resistance of the helical identifiers 908A-908N, an impedance of the helical identifiers 908A- 908N, or an electrostatic charge of the helical identifiers 908A-908N. Changes to one or more of the properties of the electrical signature detected by the control device 910 can indicate a compromised state of the internal surface 906, such as damage or a biological deposit.
[0104] FIG. 7D illustrates a focused side view of an internal portion 902 of a lumen 900 of an endoscope, in accordance with at least one example of the present disclosure. The lumen 900 can include the internal portion 902, the wall 904, the internal surface 906, first helical identifiers 908A-908N, and second helical identifiers 914A-914N. Also shown in FIG. 7D is axis A.
[0105] The lumen 900 of FIG. 7D can be the same as lumen 800 of FIG. 7C, but FIG. 7D shows that lumen 900 can include first helical identifiers 908A-908N and second helical identifiers 914A-914N. In some examples, the first helical identifiers 908A-908N and second helical identifiers 914A-914N can form a crossing double helical pattern or an intersecting rifle pattern. Such a pattern can provide a pattern or grid of identifiers running in multiple directions to help ensure that a compromised state is detected when one is present.
[0106] In some examples, the first helical identifiers 908A-908N can form a single identifier 908 along a length of the internal surface 906 and the second helical identifiers 914A-914N can form a single identifier 914 along a length of the internal surface 906. In some of these examples, the first identifier 908 and the second identifier 914 can each be electrical and/or magnetic components. For example, the first identifier 908 can be an electrical component and the second identifier 914 can be a magnetic component. In other examples, both the first identifier 908 and the second identifier 914 can be electrical components. In further examples, both the first identifier 908 and the second identifier 914 can be magnetic components. In examples where both the first identifier 908 and the second identifier 914 is an electrical component, the first identifier 908 and the second identifier 914 can connect to form a single circuit. In other examples where the first identifier 908 and the second identifier 914 are an electrical component, the first identifier 908 and the second identifier 914 can be radially spaced away from each other (for example in layers of the wall 904) to create multiple circuits.
[0107] Irregularities to or variances in the circuit(s) and/or electric or electromagnetic signature(s) created by the first identifier 908 and the second identifier 914 can help to indicate a compromised state of the internal surface 906, such as damage or a biological deposit. In these ways, a dual continuous helical patterned identifier can help to provide multiple ways of detecting a compromised state of the internal surface 906 of the lumen 900, which can help improve reprocessing quality and efficiency. FIGS. 7A and 7B are discussed below concurrently.
[0108] In some examples, the first helical identifiers 908A-908N and the second helical identifiers 914A-914N can be equally spaced and consistently opposing. However, in some examples, spacing of the first helical identifiers 908A-908N and the second helical identifiers 914A-914N can vary about the axis and/or circumference of the lumen 900. In other examples, respective angles of the first helical identifiers 908A-908N and the second helical identifiers 914A-914N can vary within the lumen 900 to indicate a location or orientation of the lumen 900.
[0109] Though the lumen 900 of FIG. 7D is shown and discussed above as having a double helix pattern, a triple, quadruple, or the like pattern can be used in other examples.
[0110] FIG. 8A illustrates a cross-section view across section 8-8 of FIG. 5 of a lumen 1000 of an endoscope, in accordance with at least one example of the present disclosure. FIG. 8B illustrates a focused cross-section view of a portion 8B of the lumen 1000 of an endoscope, in accordance with at least one example of the present disclosure. The lumen 1000 can include multiple layers which can help identify the presence of a compromised state of the lumen 1000. Any of the previously discussed examples can include a layered lumen.
[0111] The lumen 1000 can include a wall 1004, an internal surface 1006, an identifier 1008, and a lumen 1010. The wall 1004 can include a first layer 1012, a second layer 1014, and a third layer 1016. Also shown in FIG. 8A is sensor 1002 and indicator 8B. Also shown in FIG. 8B are orientation indicators Inside and Outside. [0112] In some examples, the first layer 1012 can have a first fluorescence property or behavior and the second layer 1014 can have a second fluorescence property or behavior. For example, the fluorescence of the first layer 1012 can be less intense than the fluorescence the second layer 1014. In other examples, the first layer 1012 behavior can be non-fluorescence and the second layer behavior can be fluorescent so that an examination of the internal surface 1006 using, for example, the sensor 1002, can allow a person or system to easily determine whether the internal surface 1006 is in a compromised state. That is, when damage removes a portion of the first layer 1012, the second layer can be exposed and can fluoresce to indicate the presence of the damage. Though identifiers 1008 are shown in FIGS. 8A and 8B, in some examples the layers 1012, 1014, and 1016 can be sufficient to determine the existence of a compromised state (or the lack thereof). In some of these examples, layer 1014 can be omitted.
[0113] Also, in the example where the first layer 1012 is non-fluorescent, a compound causing biological material to appear fluorescent can be used so that when any fluorescence is detected, such fluorescence indicates that the internal surface 1006 is in a compromised state and when no fluorescence is detected, the internal surface is not in a compromised state.
[0114] In other examples, each of the three layers 1012, 1014, and 1016 can have different fluorescent properties to allow a depth of damage to be assessed (because the thickness of the layers can be known). For example, if a fluorescence signal emitted by the third layer 1016 is detected, it can indicate that damage to the lumen 1000 is relatively deep. In further examples, the layers 1012, 1014, and 1016 can configured to fluoresce in different colors.
[0115] In some examples, the first layer 1012 can be have a first color and the second layer 1014 can have a second color. For example, the color of the first layer 1012 can be black and the color of the second layer 1014 can be red. In this way, when the first layer 1012 is damaged to expose the second layer 1014, an examination of the internal surface 1006 using, for example, the sensor 1002, can allow a person or system to easily determine whether the internal surface 1006 is in a compromised state.
[0116] In other examples, each of the three layers 1012, 1014, and 1016 can have different colors to allow a depth of damage to be assessed (because the thickness of the layers can be known). For example, if a color of the third layer 1016 (for example blue) is detected, it can indicate that damage to the lumen 1000 is relatively deep. [0117] In some examples, the identifier 1008A can be attached or secured to a radially inner portion of the first layer 1012. Similarly, a second identifier 1008C can also be attached or secured to a radially inner portion of the first layer 1012. Such examples can include printing or attachment of the identifiers 1008 A and 1008C to the internal surface 1006. In one example, the identifiers 1008 A and 1008C can be attached to the internal surface 1006 using an adhesive or using a hot air welding technique.
[0118] In some example, the identifier 1008B can be embedded into the first layer 1012. In other examples, the identifiers 1008B can be embedded into two or more layers. As discussed above, the identifier 1008B can be an electrical (or magnetic) identifier and can be embedded in the first layer 1012 to avoid interaction with the identifiers 1008 A and/or 1008C. In some examples, the identifier 1008B can be slightly recessed in the first layer 1012 to help reduce contact with crossing identifiers (such as identifier 1008A at another location in the lumen 1000). In other examples, the identifier 1008B can be flush with the internal surface 1006.
[0119] FIG. 9 is a block diagram illustrating an example computer system machine upon which any one or more of the previous techniques may be performed or facilitated by. Computer system 1100 specifically may be used in connection with facilitating the operations of the cleaning workflow and tracking system 380, the visual inspection processing system 360, the user computing system 430, or any other computing platform described or referred to herein. For example, the computer system 1100 can be connected to the control device 910 and/or to the borescope 502 for processing of images and signals produced during visual and electrical or electromagnetic, respectively, inspection of the lumens and lumens discussed herein.
[0120] In alternative embodiments, the machine operates as a standalone device or may be connected (e.g., networked) to other machines. In a networked deployment, the machine may operate in the capacity of either a server or a client machine in server-client network
environments, or it may act as a peer machine in peer-to-peer (or distributed) network
environments. The machine may be a personal computer (PC), a tablet PC, a smartphone, a web appliance, or any machine capable of executing instructions (sequential or otherwise) that specify actions to be taken by that machine. Further, while only a single machine is illustrated, the term“machine” shall also be taken to include any collection of machines that individually or jointly execute a set (or multiple sets) of instructions to perform any one or more of the methodologies discussed herein. [0121] Example computer system 1100 includes a processor 1102 (e.g., a central processing unit (CPU), a graphics processing unit (GPU) or both), a main memory 1104 and a static memory 1106, which communicate with each other via a link 1108 (e.g., an interlink, bus, etc.). The computer system 1100 may further include a video display unit 1110, an alphanumeric input device 1112 (e.g., a keyboard), and a user interface (UI) navigation device 1114 (e.g., a mouse). In an example, the video display unit 1110, input device 1112 and UI navigation device 1114 are a touch screen display. The computer system 1100 may additionally include a storage device 1116 (e.g., a drive unit), a signal generation device 1118 (e.g., a speaker), and a network interface device 1120 which may operably communicate with a communications network 1126 using wired or wireless communications hardware. The computer system 1100 may further include one or more human input sensors 1128 configured to obtain input (including non-contact human input) in accordance with input recognition and detection techniques. The human input sensors 1128 may include a camera, microphone, barcode reader, RFID reader, near field communications reader, or other sensor producing data for purposes of input. The computer system 1100 may further include an output controller 1130, such as a serial (e.g., universal serial bus (USB), parallel, or other wired or wireless (e.g., infrared (IR)) connection to communicate or control one or more peripheral devices (e.g., a printer, card reader, etc.).
[0122] The storage device 1116 may include a machine-readable medium 1122 on which is stored one or more sets of data structures or instructions 1124 (e.g., software) embodying or utilized by any one or more of the methodologies or functions described herein. The instructions 1124 may also reside, completely or at least partially, within the main memory 1104, static memory 1106, and/or within the processor 1102 during execution thereof by the computer system 1100, with the main memory 1104, static memory 1106, and the processor 1102 also constituting machine-readable media.
[0123] While the machine-readable medium 1122 is illustrated in an example embodiment to be a single medium, the term“machine-readable medium” may include a single medium or multiple media (e.g., a centralized or distributed database, and/or associated caches and servers) that store the one or more instructions 1124. The term“machine-readable medium” shall also be taken to include any tangible medium (e.g., a non-transitory medium) that is capable of storing, encoding or carrying instructions for execution by the computer system 1100 and that cause the computer system 1100 to perform any one or more of the methodologies of the present disclosure or that is capable of storing, encoding or carrying data structures utilized by or associated with such instructions. The term“machine-readable medium” shall accordingly be taken to include, but not be limited to, solid-state memories, and optical and magnetic media. Specific examples of machine-readable media include non-volatile memory, including, by way of example, semiconductor memory devices (e.g., Electrically Programmable Read-Only Memory (EPROM), Electrically Erasable Programmable Read-Only Memory (EEPROM)) and flash memory devices; magnetic disks such as internal hard disks and removable disks; magneto optical disks; and CD-ROM and DVD-ROM disks.
[0124] The instructions 1124 may further be transmitted or received over a communications network 1126 using a transmission medium via the network interface device 1120 utilizing any one of a number of well-known transfer protocols (e.g., frame relay, internet protocol (IP), transmission control protocol (TCP), user datagram protocol (UDP), hypertext transfer protocol (HTTP)). Examples of communication networks include a local area network (LAN), wide area network (WAN), the Internet, mobile telephone networks, Plain Old Telephone (POTS) networks, and wireless data networks (e.g., Wi-Fi, 3G, and 4G LTE/LTE-A or 5G networks).
The term“transmission medium” shall be taken to include any intangible medium that is capable of storing, encoding, or carrying instructions for execution by the computing system 1100, and includes digital or analog communications signals or other intangible medium to facilitate communication of such software.
[0125] As an additional example, computing embodiments described herein may be implemented in one or a combination of hardware, firmware, and software. Embodiments may also be implemented as instructions stored on a computer-readable storage device, which may be read and executed by at least one processor to perform the operations described herein. A computer-readable storage device may include any non-transitory mechanism for storing information in a form readable by a machine (e.g., a computer). For example, a computer- readable storage device may include read-only memory (ROM), random- access memory (RAM), magnetic disk storage media, optical storage media, flash-memory devices, and other storage devices and media.
[0126] It should be understood that the functional units or capabilities described in this specification may have been referred to or labeled as components or modules, in order to more particularly emphasize their implementation independence. Component or modules may be implemented in any combination of hardware circuits, programmable hardware devices, other discrete components. Components or modules may also be implemented in software for execution by various types of processors. An identified component or module of executable code may, for instance, comprise one or more physical or logical blocks of computer instructions, which may, for instance, be organized as an object, procedure, or function. Nevertheless, the executables of an identified component or module need not be physically located together, but may comprise disparate instructions stored in different locations which, when joined logically together, comprise the component or module and achieve the stated purpose for the component or module. Indeed, a component or module of executable code may be a single instruction, or many instructions, and may even be distributed over several different code segments, among different programs, and across several memory devices.
[0127] Similarly, operational data may be identified and illustrated herein within components or modules, and may be embodied in any suitable form and organized within any suitable type of data structure. The operational data may be collected as a single data set, or may be distributed over different locations including over different storage devices, and may exist, at least partially, merely as electronic signals on a system or network. The components or modules may be passive or active, including agents operable to perform desired functions.
[0128] FIG. 10 illustrates a schematic view of a method 1200, in accordance with at least one example of the present disclosure. Method 1200 can be a method of identifying a compromised state of an internal surface of a lumen, such as damage or the presence of biological material.
The steps or operations of method 1200 are illustrated in a particular order for convenience and clarity; many of the discussed operations can be performed in a different sequence or in parallel without materially impacting other operations. Method 1200 as discussed includes operations performed by multiple different actors, devices, and/or systems. It is understood that subsets of the operations discussed in method 1200 attributable to a single actor, device, or system could be considered a separate standalone process or method.
[0129] Method 1200 can begin at step 1202 where a signal can be delivered to an interior surface of a lumen. For example, a signal produced by the control device 910 (which can be connected to the borescope inspection system 350, the cleaning workflow and tracking system 380, and/or the visual inspection system 360 of FIG. 4) can be delivered to the interior surface 906 of the lumen 900. At step 1204, a signal modified by the interior surface (or the identifier) can be received. For example, a signal modified by the interior surface 512 can be received at the control device 910. At step 1206, a damaged portion of the interior surface of the lumen can be identified based upon the received signal. For example, damage 522 of interior surface 512 of the lumen 504 can be identified based on the received signal.
[0130] In another example, the signal can include visible light (for example the detection range 516 produced by the borescope 502) and can be used to identify the damaged portion 522 by presenting a camera image on a user interface (such as the user interface 436), where an interruption to the pattern (such as the identifier 520) is visually detectable in the camera image.
[0131] In another example, the signal can include visible light and identifying a damaged portion can include analyzing a camera image with a machine learning model (using the computing system 130) to identify an interruption to the pattern. In some examples, the interruption to the pattern can be identified (e.g., classified) by the machine learning model as biological material. In other examples, the interruption to the pattern can be identified by the machine learning model as damage to a layer of the lumen.
[0132] In some examples, the signal can include an electrical signal and the damaged portion of the interior surface of the lumen can be identified by detecting an electromagnetic property of the damaged portion. In some examples, the electromagnetic signal can include a magnetic field and the damaged portion can be identified by sensing an induced electromagnetic response to the delivered magnetic field.
[0133] FIG. 11 illustrates a schematic view of a method 1300, in accordance with at least one example of the present disclosure. Method 1300 can be a method of manufacturing a lumen including multiple layers. The steps or operations of method 1300 are illustrated in a particular order for convenience and clarity, as described above with respect to method 1200.
[0134] Method 1300 can begin at step 1302, where a first layer that defines an interior lumen can be formed. For example, the first layer 1012 can be formed to define the lumen 1010. At step 1304, a second layer can be formed below the first layer. For example, the second layer 1014 can be formed below the first layer 1012. In some examples, the second layer can have an appearance that is different than the first layer (such as a color difference). At step 1306 an electromagnetic or electrical trace can be formed in and/or on the first layer. For example, the identifier 1008 can be formed in and/or on the first layer 1012. In some examples, damage to the interior lumen is detectable based upon damage to the electromagnetic trace. [0135] In some examples, the second layer can be a different color than the first layer. In some examples, the second layer can have fluorescence properties that are different than the fluorescence properties of the first layer.
[0136] FIG. 12 illustrates a schematic view of a method 1400, in accordance with at least one example of the present disclosure. Method 1400 can be a method of reprocessing an endoscope lumen. The steps or operations of method 1400 are illustrated in a particular order for convenience and clarity, as described above with respect to method 1200.
[0137] Method 1400 can begin at step 1402, where an internal surface of an endoscope lumen can be cleaned. For example, the internal surface 1006 of the lumen 1000 can be cleaned. At step 1404, the interior surface of the lumen can be inspected using a sensor engageable with the endoscope lumen. For example, the internal surface 1006 of the lumen 1000 can be inspected using the sensor 1002 (which can be a borescope in some examples), where the sensor 1002 is engageable with the endoscope lumen 1000.
[0138] At step 1406, a sensor signal can be produced based on an identifier of the interior surface. For example, the sensor 1002 can produce a signal based on the identifier 1008 of the internal surface 1006. At step 1408, a disruption or a lack of disruption can be detected in the identifier that indicates whether a compromised state of the internal surface is present. For example, as shown in FIG. 5, the damage 522 and/or the biological deposit 524 can create a disruption in the identifier 520 that indicates that a compromised state of the internal surface 512 is present.
[0139] In some examples, the compromised state indicates presence of at least one of biological material on the interior surface and damage to the interior surface.
[0140] Although many of the preceding examples were provided with reference to endoscope processing and similar medical device cleaning settings, it will be understood that a variety of other uses may be applied in both medical and non-medical settings to identify, prevent, or reduce the potential of contamination. These settings may include the handling of hazardous materials in a various of scientific and industrial settings, such as the handling of objects contaminated with biological or radioactive agents; the human control of systems and devices configured to process and clean potentially contaminated objects; and other settings involving a contaminated object or human. Likewise, the preceding examples may also be applicable in clean room settings where the environment or particular objects are intended to remain in a clean state, and where human contact with substances or objects may cause contamination that is tracked and remediated.
[0141] Notes and Examples
[0142] Additional examples of the presently described method, system, and device embodiments include the following, non-limiting configurations. Each of the following non limiting examples may stand on its own, or may be combined in any permutation or combination with any one or more of the other examples provided below or throughout the present disclosure.
[0143] Example 1 is an endoscope lumen comprising: an elongated body comprising a wall including an interior surface and defining a lumen extending at least partially through the body, the interior surface forming an identifier exposed to the lumen, the identifier configured to indicate damage to the interior surface through an indication of a disruption in the identifier.
[0144] In Example 2, the subject matter of Example 1 optionally includes wherein the identifier is formed at least in part by a pattern on the interior surface.
[0145] In Example 3, the subject matter of any one or more of Examples 1-2 optionally include wherein the identifier is configured to indicate a presence of foreign material on the interior surface through the indication of the disruption in the identifier.
[0146] In Example 4, the subject matter of any one or more of Examples 1-3 optionally include wherein the interior surface includes a first portion and a second portion, the first portion including a first identifier having a first appearance, and the second portion including a second identifier having a second appearance different from the first appearance.
[0147] In Example 5, the subject matter of any one or more of Examples 1-4 optionally include wherein the wall includes a first layer having a first appearance on the interior surface, and the wall includes a second layer radially outward of the first layer, the second layer having a second appearance that is different than the appearance of the first layer, wherein damage to the first layer is detectable based upon the appearance of the second layer.
[0148] In Example 6, the subject matter of Example 5 optionally includes wherein the first appearance is a first color and the second appearance is a second color.
[0149] In Example 7, the subject matter of any one or more of Examples 5-6 optionally include wherein the first appearance is a first fluorescence behavior and the second appearance is a second fluorescence behavior. [0150] In Example 8, the subject matter of any one or more of Examples 5-7 optionally include wherein the wall includes a third layer radially outward of the second layer, the third layer having a third appearance that is different from the first appearance and the second appearance.
[0151] In Example 9, the subject matter of any one or more of Examples 1-8 optionally include wherein the identifier includes a conductive material, and damage is detectable based upon a change in an electrical signature of the conductive material.
[0152] In Example 10, the subject matter of any one or more of Examples 1-9 optionally include wherein the electrical signature is one of a resistance or an impedance of the conductive material.
[0153] In Example 11, the subject matter of any one or more of Examples 1-10 optionally include wherein the identifier includes a magnetic material and damage is detectable based upon a change in an electromagnetic field of the magnetic material.
[0154] Example 12 is an endoscope comprising the endoscope lumen of Example 1.
[0155] In Example 13, the subject matter of Example 12 optionally includes wherein the endoscope comprises a camera located proximate to a distal end of the elongated body.
[0156] In Example 14, the subject matter of any one or more of Examples 12-13 optionally include wherein the elongated body is provided in a flexible insertion tube extending from a set of controls of the endoscope.
[0157] In Example 15, the subject matter of any one or more of Examples 12-14 optionally include wherein the endoscope lumen provides a biopsy channel to insert, manipulate, and extract an instrument along the length of the elongated body.
[0158] In Example 16, the subject matter of any one or more of Examples 12-15 optionally include wherein the lumen at a first end of the lumen is coupled to a biopsy valve, and wherein the lumen at a second end of the lumen is open adjacent to a camera.
[0159] Example 17 is an endoscope lumen inspection system comprising: a sensor engageable with an endoscope lumen and configured to produce a sensor signal based on an indicator of an interior surface of the lumen; and a detection system operatively coupled to sensor, the detection system configured detect a disruption in the indicator of the lumen that indicates damage to the interior surface or biological material on the interior surface. [0160] In Example 18, the subject matter of Example 17 optionally includes wherein the sensor is an optical sensor sized and shaped to be inserted into a lumen of the lumen.
[0161] In Example 19, the subject matter of Example 18 optionally includes a borescope including the optical sensor, the borescope insertable into the lumen.
[0162] In Example 20, the subject matter of any one or more of Examples 17-19 optionally include wherein the sensor signal includes imaging data, and wherein damage in the lumen is detectable by the system based on a visual disruption in the indicator.
[0163] In Example 21, the subject matter of any one or more of Examples 17-20 optionally include wherein the detection system is configured determine that there is no damage to the interior surface or biological material on the interior surface based on the sensor signal of the indicator of the interior surface.
[0164] In Example 22, the subject matter of any one or more of Examples 17-21 optionally include wherein the indicator is formed at least in part by a pattern on the interior surface.
[0165] In Example 23, the subject matter of any one or more of Examples 17-22 optionally include wherein the sensor signal indicates a fluorescence of a damaged portion of the indicator of the lumen.
[0166] In Example 24, the subject matter of any one or more of Examples 17-23 optionally include wherein the sensor is an electromagnetic sensor, wherein the indicator includes a magnetic property, and wherein the detection system detects damage to the interior surface based on the electromagnetic property of the indicator.
[0167] In Example 25, the subject matter of any one or more of Examples 17-24 optionally include wherein the sensor is operably coupled to a circuit to detect an electrical property of the indicator, and wherein the detection system is configured to detect damage based upon a value of the electrical property.
[0168] Example 26 is a method of detecting damage in a lumen, the method comprising: delivering a signal to an interior surface of a lumen; and identifying a damaged portion of the interior surface of the lumen based upon a received signal modified by the interior surface.
[0169] In Example 27, the subject matter of Example 26 optionally includes wherein the signal includes visible light and identifying a damaged portion includes presenting a camera image on a user interface, wherein an interruption to the pattern is visually detectable in the camera image. [0170] In Example 28, the subject matter of any one or more of Examples 26-27 optionally include wherein the signal includes visible light and identifying a damaged portion includes analyzing a camera image with a machine learning model to identify an interruption to the pattern.
[0171] In Example 29, the subject matter of Example 28 optionally includes wherein the interruption to the pattern is identified by the machine learning model as biological material.
[0172] In Example 30, the subject matter of any one or more of Examples 28-29 optionally include wherein the interruption to the pattern is identified by the machine learning model as damage to a layer of the lumen.
[0173] In Example 31, the subject matter of any one or more of Examples 26-30 optionally include wherein the signal includes an electrical signal and identifying a damaged portion of the interior surface of the lumen includes detecting an electromagnetic property of the damage portion.
[0174] In Example 32, the subject matter of any one or more of Examples 26-31 optionally include wherein the electromagnetic signal includes a magnetic field and identifying a damaged portion includes sensing an induced electromagnetic response to the delivered magnetic field.
[0175] Example 33 is a method of manufacturing a lumen comprising: forming a first layer that defines an interior lumen; and forming a second layer below the first layer, the second layer having an appearance that is different than the first layer.
[0176] In Example 34, the subject matter of Example 33 optionally includes wherein the second layer is a different color than the first layer.
[0177] In Example 35, the subject matter of any one or more of Examples 33-34 optionally include wherein the second layer has fluorescence properties that are different than the fluorescence properties of the first layer.
[0178] Example 36 is a method of manufacturing an endoscope lumen comprising: forming a first layer that defines an interior lumen; and forming an electromagnetic trace in, on, or beneath the first layer, wherein damage to the interior lumen is detectable based upon damage to the electromagnetic trace.
[0179] Example 37 is a method of reprocessing an endoscope lumen comprising: cleaning an internal surface of an endoscope lumen; inspecting an interior surface of the lumen using a sensor engageable with the endoscope lumen; producing a sensor signal based on an indicator of the interior surface; detecting a disruption or a lack of disruption in the indicator that indicates whether a compromised state of the internal surface is present.
[0180] In Example 38, the subject matter of Example 37 optionally includes wherein the compromised state indicates presence of at least one of biological material on the interior surface and damage to the interior surface.
[0181] In Example 39, the systems, devices, or methods of any one or any combination of Examples 1 - 38 can optionally be configured such that all elements or options recited are available to use or select from.
[0182] The above detailed description includes references to the accompanying drawings, which form a part of the detailed description. The drawings show, by way of illustration, specific embodiments in which the invention can be practiced. These embodiments are also referred to herein as“examples.” Such examples can include elements in addition to those shown or described. However, the present inventors also contemplate examples in which only those elements shown or described are provided. Moreover, the present inventors also contemplate examples using any combination or permutation of those elements shown or described (or one or more aspects thereof), either with respect to a particular example (or one or more aspects thereof), or with respect to other examples (or one or more aspects thereof) shown or described herein.
[0183] In the event of inconsistent usages between this document and any documents so incorporated by reference, the usage in this document controls.
[0184] In this document, the terms“a” or“an” are used, as is common in patent documents, to include one or more than one, independent of any other instances or usages of“at least one” or “one or more.” In this document, the term“or” is used to refer to a nonexclusive or, such that“A or B” includes“A but not B,”“B but not A,” and“A and B,” unless otherwise indicated. In this document, the terms“including” and“in which” are used as the plain-English equivalents of the respective terms“comprising” and“wherein.” Also, in the following claims, the terms “including” and“comprising” are open-ended, that is, a system, device, article, composition, formulation, or process that includes elements in addition to those listed after such a term in a claim are still deemed to fall within the scope of that claim. Moreover, in the following claims, the terms“first,”“second,” and“third,” etc. are used merely as labels, and are not intended to impose numerical requirements on their objects. [0185] The above description is intended to be illustrative, and not restrictive. For example, the above-described examples (or one or more aspects thereof) may be used in combination with each other. Other embodiments can be used, such as by one of ordinary skill in the art upon reviewing the above description. Also, in the above Detailed Description, various features may be grouped together to streamline the disclosure. This should not be interpreted as intending that an unclaimed disclosed feature is essential to any claim. Rather, inventive subject matter may lie in less than all features of a particular disclosed embodiment. Thus, the following claims are hereby incorporated into the Detailed Description as examples or embodiments, with each claim standing on its own as a separate embodiment, and it is contemplated that such embodiments can be combined with each other in various combinations or permutations. The scope of the invention should be determined with reference to the appended claims, along with the full scope of equivalents to which such claims are entitled.

Claims

CLAIMS What is claimed is:
1. An endoscope lumen comprising:
an elongated body comprising a wall including an interior surface and defining a lumen
extending at least partially through the body, the interior surface forming an identifier exposed to the lumen, the identifier configured to indicate damage to the interior surface through an indication of a disruption in the identifier.
2. The lumen of claim 1, wherein the identifier is formed at least in part by a pattern on the interior surface.
3. The lumen of claim 1, wherein the identifier is configured to indicate a presence of foreign material on the interior surface through the indication of the disruption in the identifier.
4. The lumen of claim 1, wherein the interior surface includes a first portion and a second portion, the first portion including a first identifier having a first appearance, and the second portion including a second identifier having a second appearance different from the first appearance.
5. The lumen of claim 1, wherein the wall includes a first layer having a first appearance on the interior surface, and the wall includes a second layer radially outward of the first layer, the second layer having a second appearance that is different than the appearance of the first layer, wherein damage to the first layer is detectable based upon the appearance of the second layer.
6. The lumen of claim 5, wherein the first appearance is a first color and the second appearance is a second color.
7. The lumen of claim 5, wherein the first appearance is a first fluorescence behavior and the second appearance is a second fluorescence behavior.
8. The lumen of claim 5, wherein the wall includes a third layer radially outward of the second layer, the third layer having a third appearance that is different from the first appearance and the second appearance.
9. The lumen of claim 1, wherein the identifier includes a conductive material, and damage is detectable based upon a change in an electrical signature of the conductive material.
10. The catheter of claim 1, wherein the electrical signature is one of a resistance or an impedance or an electrostatic charge of the conductive material.
11. The lumen of claim 1, wherein the identifier includes a magnetic material and damage is detectable based upon a change in an electromagnetic field of the magnetic material.
12. An endoscope comprising the endoscope lumen of claim 1.
13. The endoscope of claim 12, wherein the endoscope comprises a camera located proximate to a distal end of the elongated body.
14. The endoscope of claim 12, wherein the elongated body is provided in a flexible insertion tube extending from a set of controls of the endoscope.
15. The endoscope of claim 12, wherein the endoscope lumen provides a biopsy channel to insert, manipulate, and extract an instrument along the length of the elongated body.
16. The endoscope of claim 12, wherein the lumen at a first end of the lumen is coupled to a biopsy valve, and wherein the lumen at a second end of the lumen is open adjacent to a camera.
17. An endoscope lumen inspection system comprising:
a sensor engageable with an endoscope lumen and configured to produce a sensor signal based on an indicator of an interior surface of the lumen; and a detection system operatively coupled to sensor, the detection system configured detect a disruption in the indicator of the lumen that indicates damage to the interior surface or biological material on the interior surface.
18. The system of claim 17, wherein the sensor is an optical sensor sized and shaped to be inserted into a lumen of the lumen.
19. The system of claim 18, further comprising a borescope including the optical sensor, the borescope insertable into the lumen.
20. The system of claim 17, wherein the sensor signal includes imaging data, and wherein damage in the lumen is detectable by the system based on a visual disruption in the indicator.
21. The system of claim 17, wherein the detection system is configured determine that there is no damage to the interior surface or biological material on the interior surface based on the sensor signal of the indicator of the interior surface.
22. The system of claim 17, wherein the indicator is formed at least in part by a pattern on the interior surface.
23. The system of claim 17, wherein the sensor signal indicates a fluorescence of a damaged portion of the indicator of the lumen.
24. The system of claim 17, wherein the sensor is an electromagnetic sensor, wherein the indicator includes a magnetic property, and wherein the detection system detects damage to the interior surface based on the electromagnetic property of the indicator.
25. The system of claim 17, wherein the sensor is operably coupled to a circuit to detect an electrical property of the indicator, and wherein the detection system is configured to detect damage based upon a value of the electrical property.
26. A method of detecting damage in a lumen, the method comprising:
delivering a signal to an interior surface of a lumen; and
identifying a damaged portion of the interior surface of the lumen based upon a received signal modified by the interior surface.
27. The method of claim 26, wherein the signal includes visible light and identifying a damaged portion includes presenting a camera image on a user interface, wherein an interruption to the pattern is visually detectable in the camera image.
28. The method of claim 26, wherein the signal includes visible light and identifying a damaged portion includes analyzing a camera image with a machine learning model to identify an interruption to the pattern.
29. The method of claim 28, wherein the interruption to the pattern is identified by the machine learning model as biological material.
30. The method of claim 28, wherein the interruption to the pattern is identified by the machine learning model as damage to a layer of the lumen.
31. The method of claim 26, wherein the signal includes an electrical signal and identifying a damaged portion of the interior surface of the lumen includes detecting an electromagnetic property of the damage portion.
32. The method of claim 26, wherein the electromagnetic signal includes a magnetic field and identifying a damaged portion includes sensing an induced electromagnetic response to the delivered magnetic field.
33. A method of manufacturing a lumen comprising:
forming a first layer that defines an interior lumen; and
forming a second layer below the first layer, the second layer having an appearance that is
different than the first layer.
34. The method of claim 33, wherein the second layer is a different color than the first layer.
35. The method of claim 33, wherein the second layer has fluorescence properties that are different than the fluorescence properties of the first layer.
36. A method of manufacturing an endoscope lumen comprising:
forming a first layer that defines an interior lumen; and
forming an electromagnetic trace in, on, or beneath the first layer, wherein damage to the interior lumen is detectable based upon damage to the electromagnetic trace.
37. A method of reprocessing an endoscope lumen comprising:
cleaning an internal surface of an endoscope lumen;
inspecting an interior surface of the lumen using a sensor engageable with the endoscope lumen; producing a sensor signal based on an indicator of the interior surface; and
detecting a disruption or a lack of disruption in the indicator that indicates whether a
compromised state of the internal surface is present.
38. The method of claim 37, wherein the compromised state indicates presence of at least one of biological material on the interior surface and damage to the interior surface.
PCT/US2019/059362 2018-11-05 2019-11-01 Identifiers in medical device lumen WO2020096893A1 (en)

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