Medical device inspection system with external inspection device

Abstract

The medical device inspection system includes an external inspection device. In some embodiments, the medical device inspection system includes an external inspection device and an internal inspection device. The medical device inspection system can be used to inspect the medical device for abnormalities.

Description

[Technical Field]

[0001] (Priority Claim) This application claims the benefit of and priority to U.S. Patent Application No. 63 / 380,766, filed as a PCT International Patent Application on October 25, 2023, entitled "Medical Device Inspection System with External Inspection Device," filed on October 25, 2022, the disclosure of which is incorporated herein by reference in its entirety. [Background technology]

[0002] Millions of medical devices are used daily in hospitals around the world. With continued advancements in medical and surgical procedures over the years, one long-standing trend has been toward minimally invasive procedures performed through smaller incisions or through natural orifices in the body. Examples of this trend include arthroscopic surgery, transcatheter aortic valve replacement ("TAVR"), natural orifice transluminal endoscopic surgery ("NOTES"), robotic surgery, and the like. Many of these procedures involve the use of long, flexible catheter instruments, long, thin, rigid instruments with lumens, and / or long, flexible endoscopes to visualize the procedure. Additionally, endoscopes are used in a myriad of different diagnostic and therapeutic procedures in many parts of the body.

[0003] One of the challenges with using endoscopes, fiberscopes, catheter-based medical / surgical instruments, and other long, thin, reusable instruments is how to properly and effectively clean their internal lumens. Many endoscopes and other instruments are too expensive to be disposable and must be reused. Long, small-diameter, flexible instruments can be extremely difficult to clean internally and difficult to inspect internally. Flexible instruments can not only collect bacteria and other contaminants, but can also crack or otherwise become permanently deformed during use, for example, when the instrument is bent or twisted. These instruments are typically processed in cleaning facilities located within hospitals by personnel with little training. To inspect the interior of such instruments, small, flexible scopes are inserted and advanced through the device's lumens, sometimes revealing contaminants and damage. However, it can be difficult for the inspector to effectively identify contaminants and internal damage to the device. Therefore, the inspection process can be labor-intensive and sometimes ineffective. It can also be difficult to find a scope small enough to fit through the lumens of some medical devices while still allowing adequate visualization. Additionally, once contamination of an endoscope or catheter lumen (or similar internal portion of a medical device) is identified, it can often be difficult to properly clean and / or decontaminate the lumen. Summary of the Invention [Problem to be solved by the invention]

[0004] In general, the present disclosure is directed to a medical device inspection system. In some embodiments, by way of non-limiting example, the medical device inspection system includes an external inspection device. Some embodiments further include an internal inspection device.

[0005] One aspect is a medical device inspection system that includes an internal inspection device configured to inspect the interior of a medical device and an external inspection device configured to inspect the exterior of the medical device.

[0006] A further aspect is an external inspection system for inspecting the exterior of a medical device, the external inspection system comprising an external inspection apparatus comprising a body having an interior surface defining an interior space, the body being configured to pass the medical device through the interior space during inspection of the medical device, and a camera supported by the body and directed toward the interior space to capture images of the exterior of the medical device during inspection.

[0007] Yet another aspect is a method of inspecting a medical device, the method including capturing an image of an interior of the medical device, capturing an image of an exterior of the medical device, and inspecting the medical device for anomalies using the image of the interior of the medical device and the image of the exterior of the medical device. [Brief explanation of the drawings]

[0008] [Figure 1] FIG. 1 is a schematic block diagram illustrating an exemplary medical device inspection system. [Figure 2] FIG. 2 is a block diagram illustrating an exemplary external inspection device. [Figure 3] Figure 3 shows the internal inspection device. [Figure 4] FIG. 4 is a schematic block diagram illustrating an exemplary user interface of a computing device. [Figure 5] FIG. 5 illustrates an exemplary computing device. DETAILED DESCRIPTION OF THE INVENTION

[0009] Various aspects will now be described in detail with reference to the drawings, wherein like reference numerals represent like parts and assemblies throughout the several views. Reference to various aspects does not limit the scope of the claims appended hereto. Additionally, any examples described herein are not intended to be limiting, but merely to describe some of the many possible embodiments for the appended claims.

[0010] 1 is a schematic block diagram illustrating an exemplary medical device inspection system 100 including at least an external inspection device 102. In the illustrated example, the medical device inspection system 100 includes the external inspection device 102, an internal inspection system 104, and a support structure 106. The support structure includes a medical device holder 107. Some embodiments further include an advancement device 108, a position detector 110, a computing device 111, or a combination thereof. An exemplary medical device M is also shown.

[0011] The present disclosure relates to the inspection of a medical device M, which may be one of a variety of different types of medical devices, some of which are discussed in the Background. Some medical devices have an elongated, flexible body and may include one or more internal orifices. Examples include endoscopes, fiberscopes, catheter-based medical / surgical instruments, and other reusable instruments.

[0012] The medical device inspection system 100 operates to inspect a medical device for abnormalities, which may include, for example, debris, damage (e.g., gouges, kinks, cracks), discoloration, moisture (e.g., water droplets), contaminants (e.g., biofilm or biological material), etc.

[0013] The external inspection device 102 is positioned and configured to inspect the exterior of the medical device M. An example of an external inspection device 102 is shown and described in further detail with reference to FIG.

[0014] The internal inspection system 104 is positioned and configured to inspect the interior of the medical device M. An example of an internal inspection system 104 is shown and described in further detail with reference to FIG.

[0015] In some embodiments, a support structure 106 is provided to support components of the medical device inspection system 100, such as the external inspection device 102 and the internal inspection device 104. In this example, the support structure 106 is shown configured to support the medical device M in a vertical orientation. In another possible embodiment, the support structure 106 can be configured to support the medical device M in a horizontal position. For example, the support structure can be configured to be placed on a table or can include its own table or other horizontal support structure. Other configurations are possible.

[0016] In some embodiments, the support structure 106 includes a medical device holder 107. The medical device holder 107 may include one or more clamps, clips, hangers, brackets, arms, or other structures suitable for supporting a medical device in a desired position. The medical device holder 107 allows the medical device to be easily inserted and removed from the medical device holder 107 by an operator.

[0017] Some embodiments include an advancement device 108. In some embodiments, the advancement device 108 is motorized using one or more motors. In another possible embodiment, the advancement device 108 uses friction to slow the movement of the medical device M under gravity. In this manner, some embodiments of the advancement device 108 can provide movement without the need for a motor. The advancement device 108 operates to move one or both of the medical device M and the internal inspection device 104 such that the internal inspection device moves relative to the medical device. Movement can be in either or both directions. Similarly, in some embodiments, the advancement device 108 operates to move one or both of the medical device M and the external inspection device 102, such that the external inspection device moves relative to the medical device M. In some embodiments, the advancement device 108 moves the medical device M while the external inspection device 102 and the internal inspection device 104 remain stationary.

[0018] In some embodiments, the support structure 106 includes one or more tracks. The advancement device is coupled to one or more of the medical device holder 107, the external inspection device 102, or the internal inspection device 104 and moves such components along the one or more tracks.

[0019] Some embodiments do not include an advancement device 108. For example, an operator can manually move the external inspection device 102 relative to the medical device M and / or the internal inspection device 104 relative to the medical device M.

[0020] With respect to the internal inspection device 104, in some embodiments, the internal inspection device 104 is inserted and advanced forward through the medical device M during the inspection process. In another embodiment, the internal inspection device 104 is first inserted or advanced through the medical device M and then withdrawn from the medical device M while the inspection is being performed. In yet another possible embodiment, the inspection can be performed during both the insertion and withdrawal of the internal inspection device 104.

[0021] A position detector 110 is provided in some embodiments to detect the relative position between the medical device M, the external inspection device 102, and / or the internal inspection device 104. The position detector 110 may be used, for example, to determine the position of the internal inspection device 104 as a depth within the medical device M measured from an opening, or to determine how far the external inspection device is from the same opening. Some embodiments do not include a position detector 110. For example, in some embodiments, position measurements can be made manually by an operator. In some embodiments, position measurements are input by the operator into a calculation device 111. Further, in some embodiments, the position detector 110 may be part of the advancement device 108. For example, a stepper motor may be configured to precisely control movement, such that a position can be calculated based on actuation of the advancement device.

[0022] Some embodiments include one or more computing devices 111. Computing device 111 may operate to control one or more processes of medical device inspection system 100 and / or to collect, analyze, and / or store data from other components of medical device inspection system 100. For example, images and other data from external inspection device 102, internal inspection device 104, advancement device, or position detector may be provided to computing device 111. In some embodiments, computing device 111 controls and coordinates the processes of internal inspection device 104 and external inspection device 102. An exemplary user interface display provided by computing device 111 is shown and described in further detail with reference to FIG. 4.

[0023] The medical device inspection system 100 can include one or more inspection devices. Some embodiments include an external inspection device 102. Other embodiments include an internal inspection device 104. Some embodiments include both. Further embodiments can have additional inspection devices.

[0024] The inspection devices can be activated in any order, one after the other, or simultaneously at a time. In one example, the camera of the internal inspection device 104 can be positioned at one end of the medical device M, while the external inspection device 102 is simultaneously positioned at the same end. The inspection devices 102 and 104 can then be moved at the same speed along the length of the medical device M. In this manner, the inspection devices 102 and 104 simultaneously inspect the inside and outside of the medical device at the same location relative to the length of the medical device. In an alternative embodiment, the inspection devices can be spaced apart from each other to scan separate portions of the medical device at any given time. In yet another alternative embodiment, the external inspection device 102 and the internal inspection device 104 can be activated one at a time to scan the interior and exterior separately.

[0025] 2 is a block diagram illustrating an example of an external inspection device 102. In this example, the external inspection device 102 includes a body 112 having an interior surface 114 that defines an interior space 116. One or more cameras 120 (including 120A, 120B, 120C) are supported by the body and directed inwardly toward the interior space 116.

[0026] Body 112 defines an interior space through which medical device M can pass. The medical device is preferably approximately centered within interior space 116 (e.g., concentric, although non-circular shapes are possible). In this example, body 112 is supported by support structure 106. As discussed herein, body 112 may also be movable along the support structure by an advancement device.

[0027] In some embodiments, the camera is supported in a fixed (possibly adjustable) position around the inner surface 114 of the body and has a field of view positioned inward toward the interior space 116. One or more cameras may be included. In certain examples, at least two cameras are required, one on each side, to image the entire exterior of the medical device M. However, one or more mirrors or other optical features may be used to reduce the number of cameras required. Some embodiments include three or more cameras. The illustrated example shows three cameras 102A, 102B, and 102C. Camera 102A captures video of external image A, camera 102B captures video of external image B, and camera 102C captures video of external image C.

[0028] In some embodiments, a single camera is supported on the interior surface 114 of the body to image all exterior aspects of the medical device M. In one example, the external inspection device is configured to rotate the camera about the exterior of the medical device. For example, the body 112 is rotatably mounted to the support structure 106 such that the camera captures the exterior side of the medical device as the body 112 completes one rotation with the camera having a field of view positioned inward toward the interior space 116.

[0029] The camera may also be positioned at a variety of possible angles, as desired, such as along the length of the medical device M. Such a positioning may more closely match the corresponding image captured by the internal inspection device 104. Such an angle results in a perspective view, which may provide a better view for detecting certain anomalies that may be more difficult to detect from a pure side view.

[0030] In some embodiments, the external inspection device 102 includes one or more light sources. The light sources may be positioned similarly to the cameras within the body 112 or may be offset along the length of the medical device and positioned to illuminate the interior space. One or more light sources may be provided, and the light sources may, in some embodiments, be of a number of different types. For example, the light sources may, in some embodiments, include a visible light source and an ultraviolet (UV, e.g., UV-C) light source. The light sources may be independently operable.

[0031] Some embodiments include wiring 118 that transmits power and / or data signals. In one example, wiring 118 extends through the body and is electrically connected to one or more electronic components therein, such as one or more cameras 120. In some embodiments, wiring 118 is then routed through the body and out into support structure 106. The wiring may ultimately transfer power from a power source and / or digital signals (such as from one or more cameras 120) to computing device 111.

[0032] Although the external inspection device 102 is shown as including wiring 118 connecting it to the support structure, such wiring 118 is not required by all embodiments. For example, the external inspection device 102 and / or the support structure 106 may include their own power source, e.g., a battery. Similarly, data signals may be transferred wirelessly using a wireless transceiver, such as using Wi-Fi, Bluetooth, cellular networks, satellite communications, and / or other radio frequency signals or technologies.

[0033] 3 shows an exemplary internal inspection device 104. In this example, the internal inspection device 104 comprises an inspection scope 130 that includes a control unit 132. One example of an inspection scope 130 is a borescope, such as a fiberscope. The inspection scope typically includes a light source and a camera. The internal inspection device 104 has a long, thin fiber that can be inserted and removed through the center of the medical device M and operates to capture images of the interior of the medical device M. Examples of inspection scopes are disclosed in various patent applications by Clarus Medical, LLC, including U.S. Patent Application Publication No. 2019 / 0224357, filed January 22, 2019, U.S. Patent Application Publication No. 2019 / 0282327, filed February 19, 2019, U.S. Patent Application Publication No. 2022 / 0080469, filed September 10, 2021, and U.S. Patent Application Publication No. 2022 / 0240767, filed February 3, 2022, the disclosures of which are incorporated by reference in their entireties into this specification.

[0034] The inspection scope 130 inspects the interior of the medical device M and generates inspection data. The inspection data includes any one or more of image data, video data, inspection metadata, process data to document the operation of the inspection system, or any combination thereof.

[0035] In one example, the inspection data includes images (optionally including video) captured by the inspection scope 130. Another example of inspection data is a timestamp identifying the date and / or time the image was captured. Another example of inspection data is location data from the position tracker 138 identifying the location where the image was captured. The data may be saved to a storage device. In some embodiments, the data is stored in one or more databases, which may consist of or include one or more third-party databases.

[0036] Inspection data may also include operational data. Operational data is data documenting the operation of the inspection system during an inspection. Any of a variety of data may be collected. For example, position and time data may be collected. The position and time data may be associated with captured images or video clips or recordings. Speed ​​data may be collected identifying the relative speed of movement of the inspection scope 130 with respect to the medical device. The images may be evaluated to determine image quality, and data recording the image quality may be stored.

[0037] The operational data may also include information about one or more operators (e.g., technicians) involved in one or more steps of the inspection process, such as the date and time the step occurred, and the identity of the operator, such as a name or identification number. Similarly, in some examples, information about the physical location of the cleaning or inspection station (e.g., a workstation) or building may be collected and stored. In these examples, such information may be manually entered by an operator or determined by various scanning (e.g., barcode, RFID, etc.) or location determination processes.

[0038] In some embodiments, the operational data includes information about the inspection system and / or inspection scope 130 being used to perform the inspection and scan. The information may include the manufacturer's name, model number, and / or identification number. The information may also include inspection system characteristics (e.g., length, diameter, etc.) and capabilities (e.g., cleaning function (e.g., brush), disinfection function (e.g., UV light)), and whether such capabilities were utilized. If applicable, what, when, where, how much, and / or for how long. For example, data may be collected regarding what wavelength of UV light was used (e.g., UV-C), what intensity was used, where it was used, and the length of exposure time or other dosimetry.

[0039] Storage of the test data may be temporary or permanent. For example, in some embodiments, the test data is stored for processing and unwanted data may be deleted later. In other embodiments, the test data is stored regardless of other operations.

[0040] The examination data can be stored in a variety of ways, such as in one or more files, a database, etc. In some embodiments, the images are associated with corresponding data, such as location and time data. The data can be stored in a database and associated with the images in the database. In another possible embodiment, the data can be stored in the image metadata (e.g., the time and location fields of the image), as examination metadata, or as a filename. For example, the filename can be a combination of one or more of a medical device identifier, date, time, location, and / or other data. In some embodiments, the examination data can be stored in a separate system and / or database.

[0041] Just as inspection and process data may be collected with respect to inspection scope 130, the same or similar data may be collected with respect to external inspection device 102 described herein.

[0042] The inspection scope 130 may be supported by the support structure 106. For example, the support structure 106 may include one or more clamps, clips, hangers, brackets, arms, or other structures suitable for supporting and guiding the inspection scope 130 as it enters and exits the interior of the medical device M.

[0043] In some examples, computing device 111 (shown in FIG. 1 ) includes a test analyzer for analyzing test data to identify possible anomalies in the medical device. In some embodiments, the test analyzer is or includes one or more software applications. In some embodiments, the test analyzer is or includes a neural network, such as a convolutional neural network (CNN), which may run on one or more computing devices, and may include one or more remote computing devices. One example of a neural network is a deep neural network.

[0044] In some embodiments, the test analyzer includes an anomaly detector. The anomaly detector may be or include one or more machine learning algorithms (e.g., artificial intelligence) including one or more machine learning models trained to detect or predict whether an anomaly is present. In some embodiments, the anomaly detector performs image analysis. In some embodiments, the anomaly detector performs object recognition. In some embodiments, the anomaly detector is or includes an image classifier. The anomaly detector can be or include one or more machine learning algorithms that are supervised or unsupervised machine learning algorithms. In one example, the anomaly detector automatically detects anomalies in the medical device M by processing the test data.

[0045] In some embodiments, the anomaly detector is trained on a set of training data. The training data may include positive training examples, negative training examples, or positive and negative training examples, and may include internal and / or external images of the medical device M. An example may include images of the medical device without anomalies and images of the medical device with anomalies. The training examples may be labeled with specific data, such as whether an anomaly is present or not, and / or the type or class of anomaly. For example, various anomalies are possible, including debris, damage, discoloration, liquid droplets (moisture), etc.

[0046] In some embodiments, the medical device inspection system 100 includes a position tracker for determining the relative position of at least one of (i) the external inspection device 102 with respect to the medical device, (ii) the internal inspection device 104 (e.g., inspection area) with respect to the medical device, or both. The position tracker generates quantitative data, qualitative data, or both, in various possible embodiments. The inspection data includes data generated from the position tracker. In some embodiments, the quantitative position can be a measurement. One example of a measurement is a distance from an opening in the medical device (or from another reference point). For example, the position tracker can use the opening in the medical device as a starting position and then measure the movement of the tip of the inspection scope 130 into the medical device relative to the starting position (e.g., 1 cm, 2 cm, 3 cm, 4 cm, etc.). Examples of quantitative position can be defined with respect to a particular portion or location within the medical device M, such as at or near a particular hotspot, or at or near a particular portion, edge, or other location. Such qualitative location may also be identified using quantitative measurements, or may be identified using other techniques such as image recognition. The position tracker may, in some embodiments, use both quantitative and qualitative location.

[0047] In some embodiments, the position tracker operates to identify the position when the image was taken, so that the exact location of the medical device where the image was taken is known. The position tracker may also be used to measure the velocity of the relative movement between the inspection scope 130 and the medical device. Velocity may also be calculated based on the detected positions and the duration of time elapsed between those positions.

[0048] The control unit 132 may be a specific component of the internal inspection device 104 as shown, or alternatively may be a computing device 111 to which other components (such as the external inspection device 102, the advancement device 108, and / or the position detector 110) connect.

[0049] 4 is a schematic block diagram illustrating an exemplary user interface 150 of a computing device, including an exemplary image captured by medical device inspection system 100. In this example, user interface 150 includes an external image display 152 and an internal image display 154. Some embodiments further include a data display 156 and a user input area 158.

[0050] External image display 152 displays one or more external images captured by one or more cameras 120. In this example, display device 152 includes three separate displays (View A, View B, and View C), one for each camera 102A, 102B, and 102C.

[0051] In some embodiments, image processing is performed to merge multiple images into a single (panoramic style) image and corresponding views.

[0052] Internal image display 154 displays one or more internal images captured by one or more cameras of internal inspection device 104 .

[0053] It can also display data such as the location where the image was captured and the time the image was captured.

[0054] In some embodiments, one or more user input areas 158 are provided, such as for documenting details of the medical device inspection or status.

[0055] In certain embodiments, user interface 150 includes one or more reference images. For example, user interface 150 can display a reference image for the interior of medical device M. As another example, user interface 150 can display a reference image for the exterior of medical device M. In some embodiments, the user interface displays both. The reference image can indicate, for example, how medical device M should appear without any abnormalities, or, in another example, what medical device M saw during a previous inspection. The reference image can be used by an operator or inspection analyzer to compare inspection images obtained during an inspection with the reference image.

[0056] 5 illustrates an exemplary architecture of a computing device that may be used to implement aspects of the present disclosure, including any of the computing devices disclosed herein. The computing device may be local or remote to or from the inspection area and to one or more other computing devices. The computing device may be a personal computer or a server computing device. The computing device illustrated in FIG. 5 may be used to execute the operating system, application programs, and software modules (including software engines) described herein.

[0057] Computing device 111, in some embodiments, includes at least one processing unit 180, such as a central processing unit (CPU). Various processing devices are available from various manufacturers, e.g., Intel or Advances Micro Devices. In this example, computing device 111 also includes a system memory 182 and a system bus 184 that couples various system components, including system memory 182, to processing unit 180. System bus 184 may be one of several types of bus structures including a memory bus or memory controller, a peripheral bus, and a local bus using any of a variety of bus architectures.

[0058] Examples of suitable computing devices for computing device 111 include a server computer, a desktop computer, a laptop computer, a tablet computer, a mobile computing device (such as a smartphone, an iPod® or iPad® mobile digital device, or other mobile device), or other device configured to process digital instructions.

[0059] System memory 182 includes read-only memory 186 and random access memory 188. A basic input / output system 190, containing the basic routines that function to transfer information within computing device 111, such as during start-up, is typically stored in read-only memory 186.

[0060] Computing device 111 also includes a secondary storage device 192, in some embodiments such as a hard disk drive, for storing digital data. Secondary storage device 192 is connected to system bus 184 by a secondary storage interface 194. Secondary storage device 192 and its associated computer-readable media provide non-volatile storage of computer-readable instructions (including application programs and program modules), data structures, and other data for computing device 111.

[0061] Although the exemplary environment described herein uses a hard disk drive as secondary storage, in other embodiments, other types of computer-readable storage media are used. Examples of these other types of computer-readable storage media include magnetic cassettes, flash memory cards, digital video disks, Bernoulli cartridges, compact disk read-only memories, digital versatile disk read-only memories, random access memories, or read-only memories. Some embodiments include non-transitory media. Furthermore, such computer-readable storage media may include local storage or cloud-based storage.

[0062] A number of program modules may be stored in secondary storage 192 or memory 182, including an operating system 196, one or more application programs 198, other program modules 200 (such as the software engines described herein), and program data 202. Computing device 111 may utilize a suitable operating system such as Microsoft Windows®, Google Chrome®, Apple OS, and other operating systems suitable for the computing device.

[0063] In some embodiments, a user provides input to the computing device 111 through one or more input devices 204. Examples of input devices 204 include a keyboard 206, a mouse 208, a microphone 210, and a touch sensor 212 (such as a touchpad or touch-sensitive display). Other embodiments include other input devices 204. The input devices are often connected to the processing unit 180 through an input / output interface 214 coupled to the system bus 184. These input devices 204 can be connected by any number of input / output interfaces, such as a parallel port, a serial port, a game port, a universal serial bus, or the like. Wireless communication between the input devices and the interface 214 is also possible, and in some possible embodiments includes infrared, BLUETOOTH® wireless technology, 802.11a / b / g / n, cellular, or other radio frequency communication systems.

[0064] In this example, a display device 216, such as a monitor, LCD display, projector, or touch-sensitive display, is also connected to system bus 184 via an interface, such as a video adapter 218. In addition to the display device 216, computing device 111 may include various other peripheral devices (not shown), such as speakers or a printer.

[0065] When used in a local area networking environment or a wide area networking environment (such as the Internet), computing device 111 is typically connected to the network via network interface 220, such as an Ethernet interface. Other possible embodiments use other communication devices. For example, some embodiments of computing device 111 include a modem for communicating over the network.

[0066] Computing device 111 typically includes at least some form of computer-readable media. Computer-readable media includes any available media that can be accessed by computing device 111. By way of example, computer-readable media includes computer-readable storage media and computer-readable communication media.

[0067] Computer-readable storage media include volatile and nonvolatile, removable and non-removable media implemented in any device configured to store information such as computer-readable instructions, data structures, program modules, or other data. Computer-readable storage media include, but are not limited to, random access memory, read-only memory, electrically erasable programmable read-only memory, flash memory or other memory technology, compact disc read-only memory, digital versatile disks or other optical storage devices, magnetic cassettes, magnetic tape, magnetic disk storage or other magnetic storage devices, or any other medium that can be used to store the desired information and that can be accessed by a computing device 111. Computer-readable storage media does not include computer-readable communication media.

[0068] Computer-readable communication media typically embodies computer-readable instructions, data structures, program modules, or other data in a modulated data signal such as a carrier wave or other transport mechanism and includes any information delivery media. The term "modulated data signal" refers to a signal that has one or more of its characteristics set or changed in such a manner as to encode information in the signal. By way of example, computer-readable communication media includes wired media such as a wired network or direct-wired connection, and wireless media such as acoustic, radio frequency, infrared and other wireless media. Combinations of any of the above are also included within the scope of computer-readable media.

[0069] The computing device shown in FIG. 5 is also an example of a programmable electronic device that may include one or more such computing devices, and when multiple computing devices are included, such computing devices may be coupled together with a suitable data communications network to collectively perform various functions, methods, or operations disclosed herein.

[0070] The various embodiments described above are provided by way of example only and should not be construed as limiting the scope of the claims appended hereto. Those skilled in the art will readily recognize various modifications and changes that may be made without following the exemplary embodiments and applications shown and described herein and without departing from the full scope of the following claims.

Claims

1. A medical device inspection system, comprising: an internal inspection device configured to inspect the interior of the medical device; an external inspection device configured to inspect the exterior of the medical device; A medical device inspection system comprising:

2. The medical device inspection system of claim 1 , wherein the internal inspection apparatus comprises an internal inspection scope including at least one camera, the internal inspection scope configured to capture images of the interior of the medical device.

3. The medical device inspection system of claim 1 , wherein the external inspection device comprises at least one camera configured to capture at least one image of the exterior of the medical device.

4. The medical device inspection system of claim 3 , wherein the external inspection device is configured to rotate at least one of the cameras about the exterior of the medical device.

5. The medical device inspection system of claim 4 , wherein the external inspection device comprises a body rotatably mounted to a support structure for rotating the at least one camera about the exterior of the medical device.

6. The medical device inspection system of claim 1 , further comprising a support structure configured to support the internal and external inspection devices during internal and external inspection of the medical device.

7. The medical device testing system of claim 1 , further comprising a computing device that controls and coordinates the operation of the internal testing device and the external testing device.

8. The medical device inspection system of claim 1 , wherein the internal inspection device comprises a borescope.

9. An external inspection system for inspecting the exterior of a medical device, the external inspection system comprising an external inspection device, a body having an interior surface defining an interior space through which the medical device passes during testing of the medical device; a camera supported by the body and directed toward the interior space for capturing images of the exterior of the medical device during an examination; An external inspection system comprising:

10. The external inspection system of claim 9 , further comprising a position tracker for determining a relative position of the external inspection device with respect to the medical device.

11. 10. The external inspection system of claim 9, further comprising a computing device comprising an inspection analyzer, wherein the inspection analyzer analyzes the image of the exterior of the medical device to identify possible anomalies in the medical device.

12. 12. The external testing system of claim 11, wherein the test analyzer further comprises an anomaly detector that automatically identifies possible anomalies in the medical device.

13. The external inspection system of claim 12 , wherein the anomaly detector automatically detects possible anomalies in the medical device by processing the images of the exterior of the medical device.

14. The external testing system of claim 11 , wherein the test analyzer comprises one or more trained machine learning models operating on one or more neural networks.

15. The external inspection system of claim 8 , further comprising a wireless transceiver for wirelessly transmitting data from the camera.

16. The external inspection system of claim 15 further comprising at least one battery power source that powers the camera and the wireless transceiver.

17. 1. A method for testing a medical device, the method comprising: capturing an image of the interior of the medical device; capturing an image of the exterior of the medical device; Inspecting the medical device for abnormalities using the internal image of the medical device and the external image of the medical device; A method for inspecting a medical device, comprising:

18. generating inspection data including an image of the interior of the medical device and an image of the exterior of the medical device; analyzing the inspection data using a machine learning model; generating analytical data based on an analysis of the inspection data; generating one or more outputs based on the analytical data; 20. The method of claim 17, further comprising:

19. The inspection data is (a) Image data (b) Video data (c) Examination metadata (d) Operational data documenting the operation of the inspection system. (e) any combination of (a), (b), (c) and (d); 19. The method of claim 18, wherein:

20. 20. The method of claim 18, wherein the analytical data includes a prediction of whether the medical device may have an abnormality.

Images