WO2020096891A1

WO2020096891A1 - Self-centering mechanism

Info

Publication number: WO2020096891A1
Application number: PCT/US2019/059358
Authority: WO
Inventors: Mer Win CHEONG
Original assignee: Medivators Inc.
Priority date: 2018-11-05
Filing date: 2019-11-01
Publication date: 2020-05-14

Abstract

This document discusses, among other things, systems and methods for automated lumen inspection. A self-centering mechanism can be utilized to maintain a uniform position for a borescope camera within the lumen. The self-centering mechanism can include a body, the body defining a lumen, a longitudinal channel, and a transverse groove. The body can be sized and shaped for insertion into an endoscope lumen. The lumen can extend from the distal end to the proximal end, and be sized and shaped to receive a distal end of a borescope containing a camera. The first longitudinal channel is disposed an outer surface of the body, and the first transverse groove that is transverse to the first longitudinal channel to provide flexibility along a longitudinal axis for moving around a bend in the endoscope lumen.

Description

SELF-CENTERING MECHANISM

PRIORITY CLAIN

[0001] This application claims priority to and the benefit of U.S Provisional application with serial number 62/755,903, filed on November 5, 2018, entitled SELF-CENTERING

MECHANISM which is herein incorporated by reference in its entirety.

TECHNICAL FIELD

[0002] This document relates generally to lumen inspection, and more particularly, but not by way of limitation, to systems, devices, and methods to automate and/or enhance lumen inspection with a borescope.

BACKGROUND

[0003] 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.

[0004] 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 (e.g., disinfection/sterilization) of an endoscope, through the application of disinfecting cleaning solutions. High-level disinfection or sterilization processes are typically performed after manual cleaning to remove any 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.

[0005] During existing manual cleaning procedures, a human technician may inspect the endoscope for damage and perform various types of inspections, verifications, or tests on external surfaces and operational 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.

SUMMARY

[0006] This document discusses, among other things, systems and methods for automated borescope inspection. More specifically, this document discusses a self-centering mechanism for use on a borescope for inspection of a lumen. In an example, the borescope inspection system is utilized to inspect channels (lumens) within an endoscope for potential damage or contamination prior to re-use of the endoscope. The self-centering mechanism operates to keep a borescope camera centered within a lumen under inspection. Among other things, keeping the borescope camera centered assists in obtaining uniform images of an inner surface of the lumen.

[0007] This summary 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 disclosure. The detailed description is included to provide further information about the present patent application. Other aspects of the disclosure will be apparent to persons skilled in the art upon reading and understanding the following detailed description and viewing the drawings that form a part thereof, each of which are not to be taken in a limiting sense.

BRIEF DESCRIPTION OF THE DRAWINGS

[0008] 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. [0009] FIG. 1 illustrates an overview of devices and systems involved in stages of endoscope use and reprocessing, according to various examples discussed herein.

[0010] FIG. 2 is a schematic cross-section illustration of an endoscope, operated, according to various examples discussed herein.

[0011] FIG. 3 illustrates data flows provided with a cleaning workflow and tracking system, during respective stages of endoscope use and processing, according to various examples discussed herein.

[0012] FIG. 4 is a block diagram of system components used to interface among imaging, tracking, and processing systems according to various examples discussed herein.

[0013] FIG. 5 illustrates an example system for automating endoscope working channel inspection using a borescope, according to various examples discussed herein.

[0014] FIG. 6A is a perspective view of a self-centering mechanism according to various examples discussed herein.

[0015] FIG. 6B is a side view of a self-centering mechanism, according to various examples discussed herein.

[0016] FIG. 6C is a cross-sectional view of a self-centering mechanism, according to various examples discussed herein.

[0017] FIG. 6D is an end view of a self-centering mechanism, according to various examples discussed herein.

DETAILED DESCRIPTION

[0018] 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.

[0019] Industry working groups and regulatory bodies have recommended using borescopes as a visual inspection tool for the working channels (lumens) of an endoscope. A borescope allows a user (inspector) to assess the cleanliness and identify damage within an endoscope working channel. The ability for a user (human or computerized) to conduct an accurate damage or cleanliness assessment is dependent on good image quality. Borescopes utilized for performing visual inspection are typically much smaller in diameter than the working channels of an endoscope, which typically results in inconsistent imaging as the borescope is advanced through the working channel and the camera shifts around within the working channel.

[0020] The current inventor has developed a self-centering mechanism that fits on the distal end of a borescope and positions the borescope camera at the center of the working channel. The self-centering mechanism can operate to center a borescope within varying diameter working channels, and will not inhibit operation of the borescope in working channels down close to the diameter of the borescope. As the working channel approaches the borescope diameter, a self centering mechanism may not be necessary. In some examples, the self-centering mechanism can include a larger overall diameter body with deep transverse grooves to accommodate uniform compression of the elastic material, which enable use across a wide range of lumen diameters. Details of various embodiments of the self-centering mechanism are discussed below in reference to the provided figures.

[0021] 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.

[0022] 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 sterile or high-level disinfected/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.

[0023] 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.

[0024] 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.

[0025] 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.

[0026] 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.

[0027] The borescope 126 may produce image data 132 (e.g., one or more images, such as a video) that provide 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.

[0028] 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, a detected presence of biological material, or a detected presence of channel damage. Further examples of the borescope inspection system and the visual inspection processing system are provided in the discussed examples below.

[0029] 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.

[0030] 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.

[0031] 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:

[0032] 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.

[0033] 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.

[0034] 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.

[0035] 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.

[0036] 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.

[0037] 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 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.

[0038] 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.

[0039] 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.

[0040] 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.

[0041] 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.

[0042] 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.

[0043] 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 sterile equipment and proper handling in a sterile environment.

[0044] 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 techniques, systems, and apparatus discussed herein can also be utilized for inspection operations on other instruments that include lumens that can become contaminated or damaged during use.

[0045] 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.

[0046] 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.

[0047] 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.

[0048] 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.

[0049] 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.

[0050] 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).

[0051] 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.

[0052] 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.

[0053] In various examples, input recognition used for control or identification purposes may be provided within logic or devices at 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.

[0054] 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. 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 completion certain steps or procedures.

[0055] 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.

[0056] 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.

[0057] 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.

[0058] 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.

[0059] 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.

[0060] FIG. 5 is a schematic of a borescope inspection system 350 including a borescope 352 with a self-centering mechanism 510 entering a lumen 540, according to various examples discussed herein. In this example, aspects of a borescope inspection system 350 are illustrated and discussed. This example borescope inspection system 350 is discussed to demonstrate utilization of the self-centering mechanism 510. The self-centering mechanism 510 can be used with other arrangements of a borescope inspection system. In this example, the self-centering mechanism 510 is illustrated as disposed on a distal end of a borescope 352, with the borescope 352 advancing into a working channel (lumen) 540 for inspection (e.g., an endoscope). As the borescope 352 is advanced into the working channel 540, the self-centering mechanism 510 operates to keep the distal end of the borescope centered within the working channel 540. As the inspection camera of the borescope 352 is disposed in the distal end of the borescope, keeping the distal end centered assists in providing a uniform view within the working channel 545 through the borescope camera. The uniform view enhances the ability to conduct both manual and automated inspection of the working channel 540, such as within the procedures discussed above.

[0061] In certain examples, the borescope 352 can be driven automatically into and back out of the working channel 540 using a borescope manipulator 520 (conceptually illustrated here). The borescope manipulator 520 can include a drive mechanism 525, which can include an actuator 527 and a borescope guide 526. In this example, the actuator 527 can be a stepper motor or a servo motor, with the drive mechanism using a pinch roller 528 coupled to the actuator 527 to manipulate the borescope 352. In the case of the actuator 527 being a servo motor, the drive mechanism can also include an encoder to accurately control the servo motor and borescope. Optionally, the drive mechanism 525 can include a guide roller 529 disposed within the borescope guide 526 to assist in smooth manipulation of the borescope 352. In certain examples, the guide roller 529 can also be an actuator driven roller to further enhance positive control of the borescope 352.

[0062] In this example, the inspection system 350 includes a borescope take-up reel 550 for ready storage of the elongate body portion of the borescope 352. As the borescope 352 is advanced into the lumen 540, the borescope take-up reel 550 rotates to release more of the elongate body of the borescope 352 into the borescope manipulator 520. In turn, the drive mechanism 525 feeds the borescope 352 into the lumen 540, with the self-centering mechanism 510 maintaining a uniform position of the borescope camera within the lumen 540. As discussed in detail below, the self-centering mechanism 510 includes features to maintain position within the lumen 540 through straight and curved portions of the lumen 540.

[0063] FIG. 6A is a perspective view of a self-centering mechanism 510, in accordance with various examples of the disclosure. In this example, the self-centering mechanism 510 can include a body 605 with a lumen 610 running through the center of the body 605 along a longitudinal axis 650. The lumen 610 can receive a distal end of a borescope (e.g., borescope 352). Once positioned on the distal end of a borescope, the self-centering mechanism 510 can function to position a camera within the distal end of the borescope in the center of a working channel or lumen for inspection. The body 605 can include various sections, such as a proximal portion 615 and a distal portion 625 to assist with centering the camera of the borescope. The lumen 610 running the length of the body 605 can include a proximal opening 611 and a distal opening 612. The lumen 610 can be sized to receive a distal end of a borescope. In some examples, the lumen will be sized to provide an interference fit with the target borescope to assist in securing the self-centering mechanism 510 on the borescope. In other words, the diameter of the lumen 610 through the body 605 will be slightly smaller than the outer diameter of the distal end of the borescope. In some examples, the self-centering mechanism 510 can be produced from at least semi-elastic material to further assist in installation and retention on the distal end of the borescope.

[0064] In this example, the proximal portion 615 includes a proximal taper 620. The proximal taper 620 reduces the diameter of the body 605 from a maximum proximal portion diameter to a minimal proximal portion diameter, where the minimal proximal portion diameter occurs adjacent the proximal opening 611. In this example, the maximum proximal portion diameter extends from a distal end of the proximal portion 615 to the start of the proximal taper 620. The proximal taper 620 can assist in insertion of the self-centering mechanism and borescope into a lumen (working channel) for inspection. The distal portion 625 can include a distal taper 630, which in this example mirrors the proximal taper 620. However, in other examples, the proximal taper 620 and the distal taper 630 can be different lengths and/or degrees of taper (angle). The distal taper 630 can assist in allowing the self-centering mechanism to navigate bends and corners in a lumen.

[0065] In this example, the proximal portion 615 is separated from the distal portion 625 by three elongated connecting segments 645A-645C (referenced collectively as elongate connecting segments 645). The elongate connecting segments 645 can provide for both longitudinal flexibility and torsional flexibility between the proximal portion 615 and distal portion 625 of the self-centering mechanism 510. The elongate connecting segments 645, along with flexible material construction for the entire body 605, assist in enabling the self-centering mechanism to navigate bends and corners within a lumen. Additionally, flexibility is provided by the transverse grooves 640A-640D (collectively referenced as transverse groove(s) 640). In this example, each of the proximal portion 615 and distal portion 625 includes two transverse grooves 640. In other examples, the self-centering mechanism 510 can include more or less transverse grooves 640. For example, a self-centering mechanism 510 can include a proximal portion 615 with no traverse grooves 640 and a distal portion with only one traverse groove 640.

[0066] As discussed above, one of the challenges encountered inspecting lumens with a borescope, such as a working channel of an endoscope, is residual fluid remaining within the lumen. In this example, the self-centering mechanism 510 includes one or more longitudinal channels 635A-635B (referenced collectively as longitudinal channel 635) to direct fluid away from the borescope camera. As noted above, the depth of these longitudinal channels 635 can vary depending upon the desired amount of compressibility of the overall diameter of the self centering mechanism 510. Deeper longitudinal channels 635 can provide a greater amount of uniform compressibility of the overall diameter of the self-centering mechanism 510, which allows for use in a wider range of diameter working channels. FIG. 6A illustrates a longitudinal channel 635A disposed along the length of the proximal portion 615 and longitudinal channel 635B disposed along the length of the distal portion 625. In this example, the longitudinal channel 635A and longitudinal channel 635B are aligned, but separated by the elongated connecting segments 645. In another example, the proximal portion 615 and distal portion 625 can include multiple longitudinal channels 635.

[0067] FIG. 6B is a side view of a self-centering mechanism, according to various examples discussed herein. The side view illustrates most of the same features of the self-centering mechanism 510 as discussed above in reference to FIG. 6A. The side view provides a better view of the proximal taper 620 and the distal taper 630. Additionally, the extent of the proximal portion 615 and distal portion 625 are also more easily recognized within the side view. Note, in some examples, the proximal taper 620 and the distal taper 630 are considered part of the proximal portion 615 and distal portion 625, respectively (e.g., cross-sectional view in FIG. 6C).

[0068] FIG. 6C is a cross-sectional view of a self-centering mechanism 510, according to various examples discussed herein. In this example, the lumen 610 is more easily visualized. Further, an example depth of the transverse grooves 640 is illustrated. The structure of the proximal opening 611 and distal opening 612 are also more evident. For example, the proximal opening 611 is illustrated as including a radiused comer as the opening transitions into the lumen 610. Finally, the cross-sectional view shows the partial pie-shape nature of the elongated connecting segments 745 in this example.

[0069] FIG. 6D is an end view of a self-centering mechanism, in accordance with at least on example of the disclosure. The end view illustration shows all three longitudinal channels 635A disposed in the proximal portion 715.

[0070] 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.

[0071] Example 1 is a positioning apparatus comprising: a body having a distal end, a proximal end, the body being sized and shaped for insertion into an endoscope lumen; the body comprising: a lumen extending from the distal end to the proximal end, the lumen being sized and shaped to receive a distal end of a borescope containing a camera; a first longitudinal channel on an outer surface of the body, wherein the first longitudinal channel allows fluid to move past the body in the endoscope lumen; and a first transverse groove that is transverse to the first longitudinal channel, wherein the first transverse groove provides flexibility along a longitudinal axis for moving around a bend in the endoscope lumen.

[0072] In Example 2, the subject matter of Example 1 includes, an example where the body comprises a proximal portion, a distal portion, and a plurality of elongated segments that connect the proximal end to the distal end.

[0073] In Example 3, the subject matter of Example 2 includes, an example where the body comprises three or more elongated segments. [0074] In Example 4, the subject matter of Examples 2-3 includes, an example where the first transverse groove is in the distal portion, the body further comprising a second transverse groove in the proximal portion.

[0075] In Example 5, the subject matter of Examples 2-4 includes, an example where the proximal portion and distal portion each include a plurality of the transverse grooves.

[0076] In Example 6, the subject matter of Example 5 includes, an example where each transverse groove of the plurality of traverse grooves extends around the entire circumference of the body.

[0077] In Example 7, the subject matter of Examples 2-6 includes, an example where the longitudinal axis extends along the length of the body from the proximal end to the distal end of the body , and the elongated segments are parallel to the longitudinal axis.

[0078] In Example 8, the subject matter of Examples 2-7 includes, an example where the plurality of segments define an opening in the body and the first longitudinal groove intersects the opening.

[0079] In Example 9, the subject matter of Examples 2-8 includes, an example where the first longitudinal groove is in the distal portion, the body further comprising a second longitudinal groove in the proximal portion.

[0080] In Example 10, the subject matter of Example 9 includes, an example where the second longitudinal groove is aligned with the first longitudinal groove.

[0081] Example 11 is a borescope comprising: an elongated tubular member containing a plurality of wires, the elongated tubular member sized and shaped for insertion in a channel of a reusable medical device; a camera in a distal portion of the elongated member coupled to a portion of the plurality of wires; and a positioning apparatus coupled to the elongated member proximate the camera, wherein the positioning apparatus is sized and shaped to position the camera away from a wall of the channel of the reusable medical device, wherein the positioning apparatus comprises: a body having a distal end, a proximal end, the body being sized and shaped for insertion into the channel; a lumen extending from the distal end to the proximal end of the body, the lumen being sized and shaped to receive the camera, a first longitudinal channel on an outer surface of the body, wherein the first longitudinal channel allows fluid to move past the body within the channel; and a first transverse groove that is transverse to the first longitudinal channel, wherein the first transverse groove provides radial flexibility. [0082] In Example 12, the subject matter of Example 11 includes, an example where the body comprises a proximal portion, a distal portion, and a plurality of elongated segments that connect the proximal end to the distal end, wherein the plurality of elongated segments are distributed evenly radially around a central portion of the channel.

[0083] In Example 13, the subject matter of Example 12 includes, an example where the first transverse groove is in the distal portion, the body further comprising a second transverse groove in the proximal portion.

[0084] In Example 14, the subject matter of Examples 11-13 includes, an example where the proximal portion and distal portion each include a plurality of the transverse grooves.

[0085] In Example 15, the subject matter of Example 14 includes, an example where at least a portion of the plurality of transverse grooves extend radially around the circumference of the body.

[0086] Example 16 is a device comprising: a positioning means for spacing an imaging means from a wall in a lumen, the means comprising an elongated body that is sized and shaped to extend over a borescope camera, the body extending between a distal end and a proximal end, the proximal end and distal end defining a longitudinal axis, the body comprising: means for providing axial bending relative to the longitudinal axis; and means for providing torsional flexibility around the longitudinal axis.

[0087] In Example 17, the subject matter of Example 16 includes, an example where the means for providing axial bending comprises one or more grooves that are transverse to the longitudinal axis.

[0088] In Example 18, the subject matter of Examples 16-17 includes, an example where the means for providing torsional flexibility comprises a plurality of elongated segments that couple a proximal portion of the body to a distal portion of the body, wherein the distal portion is twistable relative to the proximal portion around the axis.

[0089] In Example 19, the subject matter of Examples 16-18 includes, the imaging means and an elongated member having a distal portion coupled to the positioning means.

[0090] In Example 20, the subject matter of Example 19 includes, an example where the imaging means and elongated member are a borescope.

[0091] Example 21 is an endoscope cleaning method comprising: testing the endoscope for proper function after use in a patient procedure; performing a visual inspection of the endoscope, wherein the endoscope cleaning includes, inserting a borescope with a self-centering mechanism disposed on a distal end to center a camera within the borescope in a working channel of the endoscope; and conducting an automated cleaning process to sterilize the endoscope.

[0092] In Example 22, the subject matter of Example 21 includes, an example where performing the visual inspection includes capturing a plurality of images of an internal surface of the working channel.

[0093] In Example 23, the subject matter of Example 22 includes, an example where performing the visual inspection includes analyzing the plurality of images for damage or contamination within the working channel.

[0094] In Example 24, the subject matter of Example 23 includes, an example where analyzing the plurality of images utilizes a visual inspection processing system to automatically identify potential damage or contamination.

[0095] In Example 25, the subject matter of Examples 21-24 includes, an example where performing the visual inspection includes using an automated borescope manipulation system to advance and retract the borescope within the working channel.

[0096] In Example 26, the subject matter of Examples 21-25 includes, an example where performing the visual inspection includes updating an endoscope tracking system with results of the performing the visual inspection.

[0097] A further example of the previous subject matter (e.g., a system or apparatus) may optionally combine any portion or combination of any portion of any one or more of Examples 1-26 to include“means for” performing any portion of any one or more of the functions or methods of Examples 1-26, or a“machine-readable medium” (e.g., massed, non-transitory, etc.) including instructions that, when performed by a machine (e.g., computing machine), cause the machine to perform any portion of any one or more of the functions or methods of Examples 1- 26.

[0098] Each of these non-limiting examples can stand on its own, or can be combined in various permutations or combinations with one or more of the other examples.

[0099] 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.

[0100] In the event of inconsistent usages between this document and any documents so incorporated by reference, the usage in this document controls.

[0101] 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.

[0102] Geometric terms, such as“parallel”,“perpendicular”,“round”, or“square”, are not intended to require absolute mathematical precision, unless the context indicates otherwise. Instead, such geometric terms allow for variations due to manufacturing or equivalent functions. For example, if an element is described as“round” or“generally round”, a component that is not precisely circular (e.g., one that is slightly oblong or is a many-sided polygon) is still

encompassed by this description.

[0103] Method examples described herein can be machine or computer-implemented at least in part. Some examples can include a computer-readable medium or machine-readable medium encoded with instructions operable to configure an electronic device to perform methods as described in the above examples. An implementation of such methods can include code, such as microcode, assembly language code, a higher-level language code, or the like. Such code can include computer readable instructions for performing various methods. The code may form portions of computer program products. Further, in an example, the code can be tangibly stored on one or more volatile, non-transitory, or non-volatile tangible computer-readable media, such as during execution or at other times. Examples of these tangible computer-readable media can include, but are not limited to, hard disks, removable magnetic disks, removable optical disks (e.g., compact disks and digital video disks), magnetic cassettes, memory cards or sticks, random access memories (RAMs), read only memories (ROMs), and the like.

[0104] 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.

[0105] 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.

[0106] 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.

[0107] 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. A positioning apparatus comprising:

a body having a distal end, a proximal end, the body being sized and shaped for insertion into an endoscope lumen;

the body comprising:

a lumen extending from the distal end to the proximal end, the lumen being sized and shaped to receive a distal end of a borescope containing a camera;

a first longitudinal channel on an outer surface of the body, wherein the first longitudinal channel allows fluid to move past the body in the endoscope lumen; and

a first transverse groove that is transverse to the first longitudinal channel, wherein the first transverse groove provides flexibility along a longitudinal axis for moving around a bend in the endoscope lumen.

2. The apparatus of claim 1, wherein the body comprises a proximal portion, a distal portion, and a plurality of elongated segments that connect the proximal end to the distal end.

3. The apparatus of claim 2, wherein the body comprises three or more elongated segments.

4. The apparatus of claim 2, wherein the first transverse groove is in the distal portion, the body further comprising a second transverse groove in the proximal portion.

5. The apparatus of claim 2, wherein the proximal portion and distal portion each include a plurality of the transverse grooves.

6. The apparatus of claim 5, wherein each transverse groove of the plurality of traverse grooves extends around the entire circumference of the body.

7. The apparatus of claim 2, wherein the longitudinal axis extends along the length of the body from the proximal end to the distal end of the body, and the elongated segments are parallel to the longitudinal axis.

8. The apparatus of claim 2, wherein the plurality of segments define an opening in the body and the first longitudinal groove intersects the opening.

9. The apparatus of claim 2, wherein the first longitudinal groove is in the distal portion, the body further comprising a second longitudinal groove in the proximal portion.

10. The apparatus of claim 9, wherein the second longitudinal groove is aligned with the first longitudinal groove.

11. A borescope comprising:

an elongated tubular member containing a plurality of wires, the elongated tubular member sized and shaped for insertion in a channel of a reusable medical device;

a camera in a distal portion of the elongated member coupled to a portion of the plurality of wires; and

a positioning apparatus coupled to the elongated member proximate the camera, wherein the positioning apparatus is sized and shaped to position the camera away from a wall of the channel of the reusable medical device, wherein the positioning apparatus comprises:

a body having a distal end, a proximal end, the body being sized and shaped for insertion into the channel;

a lumen extending from the distal end to the proximal end of the body, the lumen being sized and shaped to receive the camera,

a first longitudinal channel on an outer surface of the body, wherein the first longitudinal channel allows fluid to move past the body within the channel; and

a first transverse groove that is transverse to the first longitudinal channel, wherein the first transverse groove provides radial flexibility.

12. The apparatus of claim 11, wherein the body comprises a proximal portion, a distal portion, and a plurality of elongated segments that connect the proximal end to the distal end, wherein the plurality of elongated segments are distributed evenly radially around a central portion of the channel.

13. The apparatus of claim 12, wherein the first transverse groove is in the distal portion, the body further comprising a second transverse groove in the proximal portion.

14. The apparatus of claim 11, wherein the proximal portion and distal portion each include a plurality of the transverse grooves.

15. The borescope of claim 14, wherein at least a portion of the plurality of transverse grooves extend radially around the circumference of the body.

16. A device comprising:

a positioning means for spacing an imaging means from a wall in a lumen, the means comprising an elongated body that is sized and shaped to extend over a borescope camera, the body extending between a distal end and a proximal end, the proximal end and distal end defining a longitudinal axis, the body comprising:

means for providing axial bending relative to the longitudinal axis; and

means for providing torsional flexibility around the longitudinal axis.

17. The device of claim 16, wherein the means for providing axial bending comprises one or more grooves that are transverse to the longitudinal axis.

18. The device of claim 16, wherein the means for providing torsional flexibility comprises a plurality of elongated segments that couple a proximal portion of the body to a distal portion of the body, wherein the distal portion is twistable relative to the proximal portion around the axis.

19. The device of claim 16, further comprising the imaging means and an elongated member having a distal portion coupled to the positioning means.

20. The device of claim 19, wherein the imaging means and elongated member are a borescope.

21. An endoscope cleaning method comprising:

testing the endoscope for proper function after use in a patient procedure;

performing a visual inspection of the endoscope, wherein the endoscope cleaning includes inserting a borescope with a self-centering mechanism disposed on a distal end to center a camera within the borescope in a working channel of the endoscope; and

conducting an automated cleaning process to sterilize the endoscope.

22. The method of claim 21, wherein performing the visual inspection includes capturing a plurality of images of an internal surface of the working channel.

23. The method of claim 22, wherein performing the visual inspection includes analyzing the plurality of images for damage or contamination within the working channel.

24. The method of claim 23, wherein analyzing the plurality of images utilizes a visual inspection processing system to automatically identify potential damage or contamination.

25. The method of claim 21, wherein performing the visual inspection includes using an automated borescope manipulation system to advance and retract the borescope within the working channel.

26. The method of claim 21, wherein performing the visual inspection includes updating an endoscope tracking system with results of the performing the visual inspection.