Subglottic imaging puncture scope

Abstract

A larynx imaging device includes a needle, where a wall of the needle forms a channel within the needle. The device also includes a camera mounted within the channel of the needle on an inner surface of the wall. The camera is positioned within the needle such that the camera can capture one or more images of a subglottic space within a patient. The device also includes a light source mounted within the channel of the needle adjacent to the camera, where the light source provides illumination for the camera.

Description

Atty. Dkt. No. 00100-0405 -PCTSUBGLOTTIC IMAGING PUNCTURE SCOPECROSS-REFERENCE TO RELATED APPLICATION

[0001] The present application claims the priority benefit of U.S. Provisional Patent App. No. 63 / 708,128 filed on October 16, 2024, the entire disclosure of which is incorporated by reference herein.REFERENCE TO GOVERNMENT RIGHTS

[0002] This invention was made with government support under grant number DC018666 awarded by the National Institutes of Health. The government has certain rights in the invention.BACKGROUND

[0003] Laryngoscopy is an imaging procedure that provides visualization of the posterior larynx and subglottic regions of an individual. Accurate visualization of the posterior larynx and subglottic region is essential for diagnosing several conditions, including subglottic stenosis, posterior glottic stenosis and diastasis, infracordal and subglottic pathology, and lary ngeal tumor. Laryngoscopy remains the primary method for visualizing these structures. Traditional laryngoscopy typically involves the insertion of a rigid or flexible tube equipped with a camera through the mouth or nasal cavity of the patient.SUMMARY

[0004] An illustrative larynx imaging device includes a needle, where a wall of the needle forms a channel within the needle. The device also includes a camera mounted within the channel of the needle on an inner surface of the wall. The camera is positioned within the needle such that the camera can capture one or more images of a subglottic space within a patient. The device also includes a light source mounted within the channel of the needle adjacent to the camera, where the light source provides illumination for the camera.

[0005] In one embodiment, the light source includes an optical fiber mounted within the channel of the needle adjacent to the camera. In another embodiment, the device includes a light port mounted to the inner surface of the wall of the needle, where the optical fiber is mounted within the light port. In another embodiment, the light source includes a first optical fiber mounted within the channel on a first side of the camera and a second optical fiberAtty. Dkt. No. 00100-0405 -PCT mounted within the channel on a second side of the camera. Tn one embodiment, the light source includes one or more light-emitting diodes mounted to the inner surface of the wall of the needle.

[0006] In an illustrative embodiment, the needle is sized for insertion anteriorly into a neck of the patient. In another embodiment, a tip of the needle includes a bevel to prevent obstruction of the camera by the needle. In an illustrative embodiment, the bevel comprises a portion of the tip in which the wall of the needle has been removed. In another illustrative embodiment, the camera and the light source are mounted within the bevel at the tip of the needle.

[0007] In another embodiment, the device includes a stroboscopic light source that provides a strobe light such the camera is able to capture a stroboscopic video. In one embodiment, the stroboscopic light source is part of the light source used for illumination for the camera. In another embodiment, the device includes an irrigation port mounted to the inner surface of the wall of the needle, where the irrigation port emits a liquid to remove debris from a view of the camera. In another embodiment, the device includes an irrigation source connected to the irrigation port, where the irrigation source includes a pump that controls emission of the liquid. In another embodiment, the device includes an adhesive that is used to secure the camera to the inner surface of the wall of the needle.

[0008] An illustrative method of forming a larynx imaging device includes mounting a camera within a channel of a needle on an inner surface of a wall that forms the channel, where the camera is sized to fit within a subglottic space of a patient. The method also includes mounting a light source mounted within the channel of the needle adjacent to the camera such that the light source provides illumination for the camera.

[0009] In one embodiment, the method includes mounting a light port to the inner surface of the wall of the needle, where the light source is mounted within the light port. In another embodiment, the method includes mounting a stroboscopic light port to the inner surface of the wall of the needle, and mounting a stroboscopic light source within the stroboscopic light port. In another embodiment, the method includes mounting an irrigation port to the inner surface of the wall of the needle such that the irrigation port is adjacent to the camera, and where the irrigation port is sized to emit a liquid. In another embodiment, the method includes forming a bevel at a tip of the needle, where the light source and the camera areAtty. Dkt. No. 00100-0405 -PCT mounted within the bevel. In another embodiment, the mounting the light source includes mounting a first light source on a first side of the camera and mounting a second light source on a second side of the camera. In another embodiment, mounting the camera includes applying an adhesive to the inner surface of the wall of the needle such that the adhesive secures the camera in place.

[0010] Other principal features and advantages of the invention will become apparent to those skilled in the art upon review of the following drawings, the detailed description, and the appended claims.BRIEF DESCRIPTION OF THE DRAWINGS

[0011] Illustrative embodiments of the invention will hereafter be described with reference to the accompanying drawings, wherein like numerals denote like elements.

[0012] Fig. 1 depicts a flexible laryngoscope being used for laryngoscopy in accordance with an illustrative embodiment.

[0013] Fig. 2A is a laryngoscopic image of a normal subglottis in accordance with an illustrative embodiment.

[0014] Fig. 2B is a laryngoscopic image of a subglottic stenosis in accordance with an illustrative embodiment.

[0015] Fig. 3 is a diagram depicting the size (relative to a human fingertip) of a camera that can be used in the proposed system in accordance with an illustrative embodiment.

[0016] Fig. 4 is a comparison depicting the difference between a standard laryngoscope (3.5 mm diameter) to various needles that can be used with the proposed device in accordance with an illustrative embodiment.

[0017] Fig. 5A depicts a prototype of a SIPS device that includes a microcamera (OCHTA10) with an optical fiber for illumination integrated into a medical-grade needle (gauge 16) in accordance with an illustrative embodiment.

[0018] Fig. 5B is a closeup of the tip of the needle depicting the mounted microcamera and the light source in accordance with an illustrative embodiment.

[0019] Fig. 5C depicts an image of the subglottic space in a dog cadaver obtained with the SIPS device in accordance with an illustrative embodiment.Atty. Dkt. No. 00100-0405 -PCT

[0020] Fig. 5D depicts an image of the subglottic space in a human cadaver obtained with the SIPS device in accordance with an illustrative embodiment.

[0021] Fig. 6A is a block diagram depicting an end view of the needle of the proposed system in accordance with an illustrative embodiment.

[0022] Fig. 6B is a view of the end of the needle depicting an implementation with a pair of light sources being used for illumination in accordance with an illustrative embodiment.

[0023] Fig. 7 is a flow7diagram depicting operations performed by the system to perform larynx imaging in accordance with an illustrative embodiment.

[0024] Fig. 8 is a block diagram of a system for performing laryngoscopy in accordance with an illustrative embodiment.DETAILED DESCRIPTION

[0025] Laryngoscopy is an imaging procedure that provides visualization of the posterior larynx and subglottic region for use in diagnosing conditions such as subglottic stenosis, posterior glottic stenosis and diastasis, infracordal and subglottic pathology, laryngeal tumors, etc. Traditional laryngoscopy involves inserting a tube equipped with a camera through the nose or mouth of a patient to obtain images. Fig. 1 depicts a flexible laryngoscope being used for laryngoscopy in accordance with an illustrative embodiment. In the embodiment shown, the flexible laryngoscope is inserted through a nostril of the patient, and used to capture images of the larynx region, which includes the epiglottis, the supraglottis, the vocal cord, the glottis, and the subglottis. Fig. 2A is a laryngoscopic image of a normal subglottis in accordance with an illustrative embodiment. Fig. 2B is a laryngoscopic image of a subglottic stenosis in accordance with an illustrative embodiment.

[0026] Unfortunately, traditional laryngoscopy is often unable to obtain a clear view of the posterior larynx and subglottic area due to the intricate anatomy of these regions and patient discomfort. The constraints in traditional laryngoscopy often result in incomplete visualization and inadequate assessment, complicating the diagnosis of laryngeal conditions. As an example, many laryngeal diseases have an associated posterior glottic or subglottic component that is difficult to visualize with conventional laryngoscopy. Moreover, clinical intubation procedures can lead to significant injuries in the subglottic region, causing later complications after extubation.Atty. Dkt. No. 00100-0405 -PCT

[0027] Annually, in the United States, approximately 15 million people are intubated for various reasons. Studies have show n that up to 57% of patients intubated for more than 12 hours exhibit signs of acute laryngeal injury after extubation, and prolonged intubation can cause more laryngeal issues, such as edema, vocal cord ulceration, and subglottic and tracheal stenosis. These risks have been highlighted by the COVID-19 pandemic, which has increased the number of intubations.

[0028] Given these challenges, there is a clear need for a visualization tool that provides better access to the subglottic area while enhancing patient comfort. Described herein is an imaging device that has been designed to enable comprehensive visualization of the subglottis and to be safe and feasible for awake patients in a clinical setting. The proposed device is cost-effective to ensure broad accessibility and in some embodiments can include stroboscopy capabilities to assess vocal fold vibration. The proposed device can therefore be used for complete glottic evaluation.

[0029] The miniaturization of optical systems and advancements in medical-grade integration have opened new possibilities for diagnostic tools. The proposed device, named the Subglottic Imaging Puncture Scope (SIPS), incorporates a microcamera into a medicalgrade needle. In one embodiment, the microcamera used in the SIPS device can be the OVM6948 or the OCHTA10 from Omnivision (California, USA). The OVM6948 and OCHTA10 are currently the smallest available cameras in the w orld, featuring an integrated image array, signal processing, timing, and control circuitry, all housed on a single integrated circuit. The camera dimensions are notably compact, 0.65 millimeters (mm) x 0.65 mm, with a z-height of 1.16 mm. Fig. 3 is a diagram depicting the size (relative to a human fingertip) of a camera that can be used in the proposed system in accordance w ith an illustrative embodiment. The microcameras OVM6948 and OCHTA10 offer a resolution of up to 200x200 and 400x400 pixels, respectively, and an approximate pixel size of 1 micrometer. Both systems can acquire high-quality images and video up to 30 frames / second. Despite its miniature size, the image sensor incorporates advanced imaging technology, including microlenses.

[0030] Furthermore, the camera chip is designed to be power-efficient, with a low power consumption below 25 milliWatts (mW). The illumination source can include one or two optical fibers with a diameter of ~ 100 micrometers (pm), attached to the microcamera andAtty. Dkt. No. 00100-0405 -PCT connected to an external light source. Alternatively, one or more light-emitting diodes and / or a different light source may be used. In an illustrative embodiment, the images acquired by the miniaturized camera are analyzed with a post-processing system. In one embodiment, the post-processing system includes two main components: a video bridge chip and a digital signal processor (DSP). The video bridge chip converts the camera's analog image / video signals into a digital format. After this initial processing, the DSP processes the digital signals to obtain digital images / video. Additionally, the microcamera can be wireless in one embodiment, allowing for a cable-free setup. It is to be understood that the cameras described herein are just examples, and that, in alternative embodiments, a different type of camera may be used.

[0031] The SIPS device is designed to access the subglottis area via the neck of the patient. Specifically, the device includes a needle that is anteriorly inserted into the patient’s neck such that it passes through the cricoid cartilage of the esophagus and can be positioned proximate to (e.g., below) the subglottis. Fig. 1 includes an arrow that depicts an illustrative trajectory of the needle through the front of the neck of the patient such that a tip of the needle is positioned below the subglottis (the needle can alternatively be positioned proximate to any other desired region of the lary nx). With its small diameter, a needle provides minimal invasiveness tike a simple puncture, making it significantly less invasive than a conventional laryngoscope, which is typically used through the oral or nasal passages and has a larger diameter. Fig. 4 is a comparison depicting the difference between a standard lary ngoscope (3.5 mm diameter) to various needles that can be used with the proposed device in accordance with an illustrative embodiment. As shown, needles having an outer diameter of 0.9 mm, 1.3 mm, and 1.7 mm can be used with the proposed device. Alternatively, needles of different diameter may also be used. This reduced diameter and better access enhance patient comfort and allow the procedure to be performed on awake patients in a clinical setting.

[0032] While developing the SIPS device, two different types of medical-grade needles (Allegro Medical, USA) were evaluated: gauge 16 (inner diameter: 1.19 mm, outer diameter: 1.65 mm) and gauge 18 (inner diameter: 0.83 mm, outer diameter: 1.27 mm). The microcamera and the illumination source were mounted within the inner section of each needle, with the needle wall fully covering the optical system for protection. To prevent the camera from capturing the needle tip in its field of view, the ends of the needles were carefullyAtty. Dkt. No. 00100-0405 -PCT beveled to remove a portion of the needle tip while maintaining sharpness. Fig. 4 depicts beveled tips on the various needles shown. In the gauge 16 configuration, the micro-camera and a nanopoint LED were laterally attached to the needle wall and secured with OrmoComp, a biocompatible polymer, to ensure proper alignment and stability . Alternatively, a different adhesive may be used. For the gauge 18 needle, a multimode optical fiber with a core size of 200 pm was integrated alongside the camera for illumination. An alternative to fixing the microcamera and illumination in the two needles explored is to employ a trocar system, where the microcamera and light source are housed in a thin polyimide tubing or similar biocompatible material, and inserted through the needle after the needle placed in the neck and positioned such that the beveled tip is proximate to the subglottic region.

[0033] Overall, it was found that reducing the diameter of the SIPS device results in better imaging and less patient discomfort. One way to reduce the diameter of the device is by using a smaller camera (and thus a smaller diameter needle) with lower pixel resolution (e.g., 100 x 100 pixels. 150 x 150 pixels, etc.) that results in a smaller field of view. It was also found that using biocompatible polymeric fiber to provide light instead of LEDs can be better to reduce the needle gauge. Another issue that can arise is debris (e.g., blood, tissue, phlegm, etc.) blocking the camera view after insertion of the needle. In one embodiment, to help remove debris and improve the field of view, the needle can include one or more microchannels that are designed to deliver irrigation (e.g., saline solution) to the imaging site to remove any debris in front of the camera. It was found during testing that smaller needles were better than bigger needles to avoid debris blockage in the needle hollow. Another option is to reduce the thickness of the wall of the needle to reduce the overall diameter such that larger gauge (i.e., smaller size) needles can be used.

[0034] In one embodiment, given the microcamera models' current size, needles ranging from gauge 16 to 18 (inner diameter from 1.20 mm to 0.83 mm, respectively) can be used to accommodate the camera. Further miniaturization of the camera system will allow its integration into smaller needle sizes. Fig. 5A depicts a prototype of a SIPS device that includes a microcamera (OCHTA10) with an optical fiber for illumination integrated into a medical-grade needle (gauge 16) in accordance with an illustrative embodiment. As shown, the embodiment of Fig. 5 A includes an optical fiber mounted in the needle such that light from a light source (i.e., .connected to the optical fiber) can be used to illuminate the desired area for imaging. In one embodiment, instead of an optical fiber, one or more nanopoint light-Atty. Dkt. No. 00100-0405 -PCT emitting diodes may be mounted within the needle to provide illumination for the camera. Fig. 5B is a closeup of the tip of the needle depicting the mounted microcamera and the light source in accordance with an illustrative embodiment. As shown, the needle tip is beveled (i.e., a portion of the needle wall at the tip has been removed) to help prevent the needle wall from blocking the camera view. Fig. 5C depicts an image of the subglottic space in a dog cadaver obtained with the SIPS device in accordance with an illustrative embodiment. Fig. 5D depicts an image of the subglottic space in a human cadaver obtained with the SIPS device in accordance with an illustrative embodiment.

[0035] Fig. 6A is a block diagram of the system that depicts an end view of the needle in accordance with an illustrative embodiment. The needle 600 is formed by a wall that includes an inner surface and an outer surface. The end of the wall of the needle 600 includes a bevel 605, the open part of which is positioned at the top of the needle in the orientation shown in the figure. As discussed above, the bevel 605 is used to help ensure that the needle wall does not block the view of the components mounted thereto. Specifically, mounted to the inner surface of the needle 600 are a camera (or other optical sensor) 610, an irrigation port 615, a light port 620, and a stroboscopy port 625. As show n, each of these components is mounted to the inner surface with an adhesive 630. The adhesive 630 used can be OrmoComp in one embodiment. Alternatively, a different type of biocompatible adhesive may be used. In another alternative embodiment, the components can be mounted to the inner surface of the needle using a different technique, such as soldering. In another embodiment, the needle 600 can be manufactured (e.g., molded) to include integral ports that act as the irrigation port 615, the light port 620, and the stroboscopy port 625.

[0036] The camera 610 can be any of the microcameras described herein, or alternatively any other type of optical sensor that is able to fit within the opening of the needle 600. In one embodiment, the camera 610 includes a processor, memory, and other computing components such that the camera 610 can perform onboard processing and send results to a remote computing device for viewing and / or further analysis. In one embodiment, the camera 610 includes a wireless transceiver (receiver and transmitter) that allows it to communicate wirelessly with the remote computing device. The remote computing device can be a smartphone, laptop computer, desktop computer, etc. In such an embodiment, the camera 610 can include an onboard battery for power. Alternatively, the camera 610 may be wired to the remote computing device. In such an embodiment, wires can run through the interior of theAtty. Dkt. No. 00100-0405 -PCT needle 600 and connect to the camera 610. The wires can provide power, communication, and / or data transmission capabilities. In one embodiment, the wires can be positioned in a wire conduit / port mounted to the inner surface of the needle 600.

[0037] As shown, the irrigation port 615 is positioned adjacent to the camera 610. In one embodiment, a tip of the irrigation port 615 can be angled toward the camera 610 such that emitted liquid is directed toward the camera. The irrigation port 615 is connected to an irrigation source 635 that holds a liquid and pump to move the liquid from the irrigation source into and through the irrigation port 615. The liquid can be a saline solution, water, or other biocompatible liquid. As discussed above, the liquid is used to remove debris that may get between the optical sensor of the camera 610 and the region being monitored. In one embodiment, the user can control the pump of the irrigation source 635 to control when the liquid is emitted from the irrigation port 615. The user can also control a pressure at which the liquid is emitted from the irrigation port 615. For example, in some embodiments an initial pressure may be insufficient to remove debris blocking the optical sensor of the camera 610. In such a scenario, the user may increase the liquid pressure to help remove the debris.

[0038] In one embodiment, the light port 620 holds an optical fiber that is connected to a light source 640. The light source 640 can be a light-emitting diode, a laser, etc. that is used to illuminate the optical fiber. In an alternative embodiment in which an optical fiber is not used, the light port 620 can include an LED or other type of light source mounted therein (i.e., instead of being external to the needle, the light source 640 can be mounted within the needle along with the other camera, etc.). In such an embodiment, the light source 640 can be connected to a power / control source that is wired to the LED or other light. In such an embodiment, the wires can be routed through the light port 620. In another embodiment, the LED or other light source mounted in the light port 620 can be wirelessly controlled and can include a battery power source such that no wiring is needed. In such an embodiment, the LED or other light source may be mounted directly to the inner surface of the needle such that the light port 620 is not needed. The optical fiber, LED, or other light source is used to illuminate a region of interest such that the region of interest can be captured by the image sensor of the camera 610.

[0039] The stroboscopy port 625 can be sized to hold an optical fiber that is connected to the stroboscopy source 645. The stroboscopy source 645 can be an LED. laser, or other typeAtty. Dkt. No. 00100-0405 -PCT of light that is controlled to act as a strobe light. The strobe light (i.e., emitted through the optical fiber) is used to obtain slow motion video of vocal folds within the larynx for diagnosis of various speech and voice problems. In an alternative embodiment, instead of an optical fiber, the stroboscopy source 645 itself can be mounted within the stroboscopy port 625. In such an embodiment, similar to the above-discussed light source, the stroboscopy source 645 can be wired with wires running through the stroboscopy port 625 or wireless such that power and control is provided wirelessly. In another alternative embodiment, the stroboscopy port 625 may not be included and the stroboscopy source 645 can be mounted directly to the inner surface of the needle 600. In another alternative embodiment, the device may not perform stroboscopy and in such an embodiment the stroboscopy port may not be included in the device.

[0040] In another alternative embodiment, the stroboscopy port 625 and the light port 620 can be combined into a single port (e.g., the port 620 can be the single port and the stroboscopy port 645 can be removed). The single port can include a first optical fiber that is connected to the light source 640 and a second optical fiber that is connected to the stroboscopy source 645. Alternatively, a single optical fiber can be used to perform both general lighting operations (i.e., constant light) and stroboscopy (i.e., strobe light) for the optical sensor. In another alternative embodiment, the light source and the stroboscopy source may both be mounted within the single port such that any w iring for the devices may be run through the single port.

[0041] In one embodiment, the device can include a pair of light ports such that a light port is positioned on each side of the camera 610 to help improve overall illumination. The pair of light ports can hold optical fibers, LED light sources, or other light sources, depending on the implementation. In such an embodiment, both light ports can be illuminated by the same light source. Alternatively, each of the two light ports can be connected to (or include) a separate light source.

[0042] Fig. 6B is a view of the end of the needle depicting an implementation with a pair of light sources being used for illumination in accordance with an illustrative embodiment. As show n, mounted to an inner surface of the wall of the needle 600 is a camera 610, a first light port (or alternatively light source) 655 positioned on a first side of the camera 610, and a second light port (or alternatively light source) 660 positioned on a second side of the cameraAtty. Dkt. No. 00100-0405 -PCT610. The first light port 655 and the second light port 660 can house fiber optic cables that connect to light sources or the light sources themselves (e.g., LED lights) such that wiring for the light sources runs through the ports. Alternatively, as noted above, the first light port 655 and the second light port 660 may be replaced by wireless light sources that do not utilize a conduit / port for wires. This embodiment provides enhanced illumination for the camera 610 such that better images / video can be captured. Also included are an irrigation port 665 and a stroboscopic light port (or light source) 670. In an alternative embodiment, the stroboscopic light port (or light source) 670 may not be included and / or the stroboscopic light source may be incorporated into one or both of the first light port 655 and the second light port 660.

[0043] Fig. 7 is a flow diagram depicting operations performed by the system to perform larynx imaging in accordance with an illustrative embodiment. In alternative embodiments, fewer, additional, and / or different operations may be performed. Also, the use of a flow diagram is not meant to be limiting with respect to the order of operations performed. In an operation 700, the optical sensor of the system is activated. As discussed, the optical sensor (or camera) is mounted within the needle, and the needle is inserted into the patient such that a beveled tip of the needle is proximate to a region of interest, which in the present context can be any portion of the larynx region. In an operation 705, a light source for the optical sensor is activated. The light source is used to illuminate the region of interest such that the optical sensor is able to capture images thereof.

[0044] In an operation 710, the system (or a user thereof) makes a determination regarding whether a view of the region of interest is clear. If it is determined that the view is not clear (e.g., there are debris on the optical sensor and / or debris in between the optical sensor and the region of interest), the system activates an irrigation source to clean the debris out of the way in an operation 715. As discussed above, the irrigation source can include a pump that pumps a liquid through a port of the syringe to clean the optical sensor and remove debris in its vicinity. After activating the irrigation source, the system again determines whether a view of the region of interest is clear in the operation 710, and this process continues until it is determined that the view is clear enough to obtain valuable images of the region of interest.

[0045] Once it is determined that the view of the region of interest is clear, the system captures images / video of the region of interest using the optical sensor and the light source asAtty. Dkt. No. 00100-0405 -PCT described herein in an operation 720. In an operation 725, the system performs stroboscopy of the region of interest, if needed. As discussed, the stroboscopy can be performed using a separate stroboscopy source (e.g., strobe light), or by using the light source in a strobe mode. In an operation 730, the system outputs results for further analysis. The results can be digital images and / or video, raw data that can be converted into digital images and / or video, a stroboscopic slow motion video, metadata (e.g., timestamps) associated with the image / video data, etc.

[0046] In another illustrative embodiment, the captured images / video can be analyzed by a processing apparatus (e.g., computing system) to help identify issues, make diagnoses, recommend treatment, etc. The processing system can be connected to an output device (e.g., a display) that can interpret the results and display them to the physician and / or patient. Fig. 8 is a block diagram of a system for performing laryngoscopy in accordance with an illustrative embodiment. The block diagram of Fig. 8 includes a computing system 800 and a subglottic imaging puncture scope device 840 for capturing images of the subglottal region, etc. In one embodiment, at least a portion of the computing system 800 can be remote from the SIPS device 840, but in communication therewith through a network 835 or other form of wireless communication. In another embodiment, the computing system 800 can be incorporated into the SIPS device 840.

[0047] As shown, the SIPS device 840 includes an optical sensor 845, which can be a microcamera as described herein. The SIPS device 840 also includes a light and / or stroboscopic source 680, which can be in the form of one or more fiber optic cables, one or more light-emitting diodes (LEDs) (e.g., positioned on opposite sides of the optical sensor 845), etc. As discussed, the optical sensor 845 and the light and / or stroboscopic source 850 are housed within a channel of the needle, and are positioned at a tip of the needle such that images / video can be captured once the needle is inserted into a patient. The SIPS device 840 also includes an irrigation source 855, which includes a liquid for flushing the region of interest, as discussed above.

[0048] The computing system 800 includes a processor 805, an operating system 810, a memory 815, a display 818, an input / output (I / O) system 820, a network interface 825, and a laryngoscopic application 830. In alternative embodiments, the computing system 800 may include fewer, additional, and / or different components. The components of the computingAtty. Dkt. No. 00100-0405 -PCT system 800 communicate with one another via one or more buses or any other interconnect system. The computing system 800 can be any type of computing system (e.g., smartphone, tablet, laptop, desktop, etc.), including a dedicated standalone computing system that is designed to perform the laryngoscopic analysis and diagnosis. As discussed, in one embodiment, at least a portion of the computing system 800 may be incorporated into the SIPS device 840.

[0049] The processor 805 can be in electrical communication with and used to control any of the system components described herein. For example, the processor 805 can be used to execute the laryngoscopic application 830, control the optical sensor 845, control the light and / or stroboscopic source 850, control the irrigation source 855. obtain and process captured image data, generate a diagnosis, generate an alert (e.g., a textual or audible message) based on the diagnosis, etc. The processor 805 can be any type of computer processor known in the art and can include a plurality of processors and / or a plurality of processing cores. The processor 805 can include a controller, a microcontroller, an audio processor, a graphics processing unit, a hardware accelerator, a digital signal processor, etc. Additionally, the processor 805 may be implemented as a complex instruction set computer processor, a reduced instruction set computer processor, an x86 instruction set computer processor, etc. The processor 805 is used to run the operating system 810, which can be any type of operating system.

[0050] The operating system 810 is stored in the memory 815, which is also used to store programs, received image data, other patient data, network and communications data, peripheral component data, the laryngoscopic application 830, and other operating instructions. The memory 815 can be one or more memoiy systems that include various types of computer memory such as flash memory, random access memory (RAM), dynamic (RAM), static (RAM), a universal serial bus (USB) drive, an optical disk drive, a tape drive, an internal storage device, a non-volatile storage device, a hard disk drive (HDD), a volatile storage device, etc. In some embodiments, at least a portion of the memoiy' 815 can be in the cloud to provide cloud storage for the system. Similarly, in one embodiment, any of the computing components described herein (e.g.. the processor 805, etc.) can be implemented in the cloud such that the system can be run and controlled through cloud computing.Atty. Dkt. No. 00100-0405 -PCT

[0051] The I / O system 820 is the framework which enables users and peripheral devices to interact with the computing system 800. The display 818 can include a touch screen in some embodiments, and the touch screen can be part of the I / O system 820 that allows a user to make selections, control sub-systems, view results, etc. The display 818 can be any type of display, including a monitor, projector, LED screen, liquid crystal display (LCD) screen, etc., and can be used to present user interface screens, control screens, captured images, captured video, a diagnosis, and other data to the user. The I / O system 820 can also include one or more speakers, one or more microphones, a keyboard, a mouse, one or more buttons or other controls, etc. that allow the user to interact with and control the computing system 800 and / or the SIPS device 840. The I / O system 820 also includes circuitry and a bus structure to interface with peripheral devices such as the SIPS device 840, power sources, universal service bus (USB) devices, data acquisition cards, peripheral component interconnect express (PCIe) devices, serial advanced technology attachment (SATA) devices, high-definition multimedia interface (HDMI) devices, proprietary connection devices, etc.

[0052] The network interface 825 includes transceiver circuitry (e.g., a transmitter and a receiver) that allows the computing system 800 to transmit and receive data to / from other devices such as remote computing systems, servers, websites, the SIPS device 840, etc. The network interface 825 enables communication through the network 835, which can be one or more communication networks. The network 835 can include a cable network, a fiber network, a cellular network, a wi-fi network, a landline telephone network, a microwave network, a satellite network, etc. The network interface 825 also includes circuitry to allow device-to-device communication such as Bluetooth® communication.

[0053] The laryngoscopic application 830 can include software and algorithms in the form of computer-readable instructions which, upon execution by the processor 805, performs any of the various operations described herein such as controlling the optical sensor 840 to capture images and / or video, controlling the light and / or stroboscopic source 850 to illuminate the area of interest for capturing images and / or to provide a strobe light effect for performing stroboscopy, controlling the irrigation source 855 as needed until a view of the region of interest is clear, analyzing the captured images and / or video, altering settings of the SIPS device 840, analyzing patient data, making a diagnostic prediction based on the analysis, generating a warning if the analysis identifies a potential problem with the patient, displaying images and / or a w arning or diagnosis on the display 818, etc. The laryngoscopicAtty. Dkt. No. 00100-0405 -PCT application 830 can utilize the processor 805 and / or the memory 815 and / or the display 818 as discussed above. In an alternative implementation, the laryngoscopic application 830 can be remote or independent from the computing system 800, but in communication therewith.

[0054] As discussed above, visualizing the subglottic region is challenging with traditional laryngoscopy devices due to their larger size and invasiveness, which results in patient discomfort and often incomplete views of the region of interest. The proposed Subglottic Imaging Puncture Scope device addresses these problems by integrating a microcamera into a medical-grade needle, allowing access through a neck of the patient to access the subglottic area. The SIPS device enables minimally invasive, high-resolution image / video of the subglottic region, enhancing patient comfort and allowing procedures to be performed on awake patients. The SIPS device is cost-effective and in some embodiments can be wireless and have a cable-free setup, making it a versatile and accessible tool for various clinical settings.

[0055] In summary', the subglottic imaging puncture scope (SIPS) is a novel visualization tool designed to enhance the diagnosis of subglottic and lary ngeal conditions. SIPS provides high-resolution imaging with minimal invasiveness by integrating the world’s smallest camera into a medical-grade needle. The device enables access to the subglottic region through the neck, significantly improving patient comfort and allowing procedures to be performed on awake patients. In one embodiment, the high-resolution microcamera used in SIPS measures just 0.65 mm x 0.65 mm. The microcamera captures detailed images and videos in real-time at up to 30 frames / second. This microcamera features an integrated image array, signal processing, timing, and control circuitry housed on a single integrated circuit. Advanced imaging technology7, including microlenses, ensures high-quality7visuals despite the camera's miniature size. The microcamera is also designed to be power-efficient. As also discussed, in one embodiment the SIPS device incorporates optical fibers with a diameter of approximately 100 micrometers, which are connected to an external light source to provide illumination of the subglottic region.

[0056] The word "illustrative" is used herein to mean serving as an example, instance, or illustration. Any aspect or design described herein as "illustrative" is not necessarily to be construed as preferred or advantageous over other aspects or designs. Further, for the purposes of this disclosure and unless otherwise specified, "a" or "an" means "one or more.”Atty. Dkt. No. 00100-0405 -PCT

[0057] The foregoing description of illustrative embodiments of the invention has been presented for purposes of illustration and of description. It is not intended to be exhaustive or to limit the invention to the precise form disclosed, and modifications and variations are possible in light of the above teachings or may be acquired from practice of the invention. The embodiments were chosen and described in order to explain the principles of the invention and as practical applications of the invention to enable one skilled in the art to utilize the invention in various embodiments and with various modifications as suited to the particular use contemplated. It is intended that the scope of the invention be defined by the claims appended hereto and their equivalents.

Claims

Atty. Dkt. No. 00100-0405 -PCTWHAT IS CLAIMED IS:

1. A larynx imaging device comprising: a needle, wherein a wall of the needle forms a channel within the needle; a camera mounted within the channel of the needle on an inner surface of the wall, wherein the camera is positioned within the needle such that the camera can capture one or more images of a subglottic space within a patient; and a light source mounted within the channel of the needle adjacent to the camera, wherein the light source provides illumination for the camera.

2. The device of claim 1, wherein the light source includes an optical fiber mounted within the channel of the needle adjacent to the camera.

3. The device of claim 2, further comprising a light port mounted to the inner surface of the wall of the needle, wherein the optical fiber is mounted within the light port.

4. The device of claim 1, wherein the light source includes a first optical fiber mounted within the channel on a first side of the camera and a second optical fiber mounted within the channel on a second side of the camera.

5. The device of claim 1, wherein the light source includes one or more light-emitting diodes mounted to the inner surface of the wall of the needle.

6. The device of claim 1, wherein the needle is sized for insertion anteriorly into a neck of the patient.

7. The device of claim 1, wherein a tip of the needle includes a bevel to prevent obstruction of the camera by the needle, and wherein the bevel comprises a portion of the tip in which the wall of the needle has been removed.

8. The device of claim 7, wherein the camera and the light source are mounted within the bevel at the tip of the needle.Atty. Dkt. No. 00100-0405 -PCT9. The device of claim 1, further comprising a stroboscopic light source that provides a strobe light such the camera is able to capture a stroboscopic video.

10. The device of claim 9, wherein the stroboscopic light source is part of the light source used for illumination for the camera.

11. The device of claim 1, further comprising an irrigation port mounted to the inner surface of the wall of the needle, wherein the irrigation port emits a liquid to remove debris from a view of the camera.

12. The device of claim 11, further comprising an irrigation source connected to the irrigation port, wherein the irrigation source includes a pump that controls emission of the liquid.

13. The device of claim 1, further comprising an adhesive that is used to secure the camera to the inner surface of the wall of the needle.

14. A method of forming a larynx imaging device, the method comprising: mounting a camera within a channel of a needle on an inner surface of a wall that forms the channel, wherein the camera is sized to fit within a subglottic space of a patient; and mounting a light source mounted within the channel of the needle adjacent to the camera such that the light source provides illumination for the camera.

15. The method of claim 14, further comprising mounting a light port to the inner surface of the wall of the needle, wherein the light source is mounted within the light port.

16. The method of claim 14, further comprising mounting a stroboscopic light port to the inner surface of the wall of the needle, and mounting a stroboscopic light source within the stroboscopic light port.Atty. Dkt. No. 00100-0405 -PCT17. The method of claim 14, further comprising mounting an irrigation port to the inner surface of the wall of the needle such that the irrigation port is adjacent to the camera, wherein the irrigation port is sized to emit a liquid.

18. The method of claim 14, further comprising forming a bevel at a tip of the needle, wherein the light source and the camera are mounted within the bevel.

19. The method of claim 14, wherein mounting the light source comprises mounting a first light source on a first side of the camera and mounting a second light source on a second side of the camera.

20. The method of claim 14, wherein mounting the camera comprises applying an adhesive to the inner surface of the wall of the needle such that the adhesive secures the camera in place.

Images