Flexible Scope Device

Abstract

A portable medical endoscope is provided, comprising: a flexible portion having a proximal end and a distal end, the flexible portion including a curved portion and a tip at the distal end, the tip including an imaging device; a control disposed at the proximal end of the flexible portion; and a detachable monitor configured to removably engage with the control; the control including: (i) an angulation mechanism coupled to the curved portion and the tip, the angulation mechanism controlling movement of the tip; and (ii) a handle in a pistol grip configuration, the flexible portion and the control being integrally formed, waterproof, and capable of withstanding high level disinfection conditions.

Description

[Technical field]

[0001] This application claims the benefit of priority to Singapore Application No. 10202111999X, filed on October 28, 2021, the contents of which are incorporated herein by reference in their entirety for all purposes.

[0002] The present invention relates to a flexible scope, and more particularly to a low-cost, portable, reusable flexible endoscope system. [Background technology]

[0003] In developing countries, most patients are unable to get complete work-up for Head and Neck Cancer (HNC) at local and regional clinics / hospitals. This is because these primary care facilities lack adequate facilities. Patients are referred to national and central hospitals for basic work-up, but these tertiary level facilities are often overcrowded and overburdened. Most of these tertiary care centers are found to have problems that could have been treated or addressed at local facilities. Moreover, treatment for HNC patients who require tertiary level care may be delayed due to travel time, costs, and waiting times due to overloaded national and central facilities.

[0004] Currently, reusable flexible endoscopy systems in tertiary care centers cost approximately $50,000 or more, and their use is limited to a single room due to their large size and weight. While such systems are used as standard of care for clinical cancer testing in developed countries, the situation is different in low- and middle-income countries (LMICs) due to the high cost of flexible endoscopy systems.

[0005] A typical alternative solution to expensive and bulky reusable flexible endoscope systems is the use of disposable flexible endoscopes connected to a video pad. Disposable flexible endoscopes offer a more affordable initial capital investment than their reusable counterparts. However, these disposable endoscopes have single-use disposable parts, making these systems more expensive in the long run compared to reusable flexible endoscopes and less environmentally sustainable, making these disposable endoscopes unsuitable for LMICs.

[0006] Typically in LMICs, clinicians use rigid endoscopy systems, which are slightly more affordable than flexible ones. However, the rigid nature of the scope means that it lacks comfort, versatility, and ease of use when compared to flexible scopes. Rigid scopes usually consist of a metal shaft with an angled lens at the end of the scope to facilitate viewing of the oropharynx and larynx during the examination. Rigid scopes are inserted through the mouth while the patient protrudes their tongue and the healthcare provider holds it down. Rigid endoscopy has significant disadvantages for both the patient and the examining physician, including: 1) stimulation of the gag reflex in the majority of patients, 2) limited view of the upper aerodigestive tract due to the fixed angle lens of the scope, 3) limited examination of laryngeal function due to tongue retraction by the healthcare provider, and 4) high difficulty in examining tumors in the nasal cavity and nasopharynx. Summary of the Invention [Problem to be solved by the invention]

[0007] Thus, what is needed is a low cost, portable, reusable flexible endoscopic system. Furthermore, other desirable features and characteristics will become apparent from the following detailed description and the appended claims, taken in conjunction with the accompanying drawings and the background of this disclosure. [Means for solving the problem]

[0008] In one aspect, the present invention provides a portable medical endoscope comprising: a flexible portion having a proximal end and a distal end, the flexible portion including a curved portion and a tip at the distal end, the tip including an imaging device; a control disposed at the proximal end of the flexible portion; and a detachable monitor configured to removably engage with the control; the control including: (i) an angulation mechanism coupled to the curved portion and the tip, the angulation mechanism controlling movement of the tip, and (ii) a handle in a pistol grip configuration, the flexible portion and the control being integrally formed to form a single article, the single article being waterproof and capable of withstanding high level disinfection conditions.

[0009] In one embodiment, the curved portion comprises a plurality of vertebrae.

[0010] In one embodiment, the vertebrae are joined together by hinges.

[0011] In one embodiment, the tip is made of stainless steel.

[0012] In one embodiment, the stainless steel is SUS304.

[0013] In one embodiment, the imaging device includes a complementary metal oxide semiconductor (CMOS) sensor.

[0014] In one embodiment, the curved portion is made of precipitation hardened stainless steel.

[0015] In one embodiment, the precipitation hardening stainless steel is SUS631.

[0016] In one embodiment, the curved portion is covered by a curved rubber.

[0017] In one embodiment, the curved rubber is made of a high performance fluoroelastomer.

[0018] In one embodiment, the high performance fluoroelastomer is Viton™.

[0019] In one embodiment, the control unit further includes a pressure valve for measuring an internal pressure of the control unit.

[0020] In one embodiment, the detachable monitor is an LCD monitor.

[0021] In one embodiment, the detachable monitor includes a rechargeable battery.

[0022] In one embodiment, the angulation mechanism includes a lever configured to control the angle of the tip and a crankshaft coupled to the lever and a pair of angulation wires extending from the control to the tip, such that displacement of the lever actuates the crankshaft to move the pair of angulation wires, thereby angulating the tip.

[0023] In one embodiment, the angulation mechanism allows the tip to be angulated up to 150 degrees in two directions in a single plane, for a total angulation of 300 degrees.

[0024] In one embodiment, the portable medical endoscope described herein further includes one or more buttons disposed on the control unit for activating functions of the imaging device. Effect of the Invention

[0025] Advantageously, in addition to being constructed of medical grade materials and being compatible for use in ENT in terms of size and dimensions, the present invention is also portable (no endoscope stack required), compact (includes a detachable LCD monitor), inexpensive (requires fewer parts and precision instruments typically required in a clinical setting), durable (capable of withstanding numerous bending cycles due to the use of the angulation mechanism described below and the materials selected for the device), chemically resistant (e.g., ability to withstand high levels of disinfectant solutions), and easy to use (due in part to the configuration of the pistol grip handle).

[0026] The invention will be better understood with reference to the detailed description, taken in conjunction with the non-limiting examples and the accompanying drawings, in which: [Brief description of the drawings]

[0027] [Figure 1] FIG. 1 shows a side plan view of a portable medical endoscope according to the present embodiment. [Diagram 2] FIG. 2 shows a front plan view of the handheld medical endoscope of FIG. [Diagram 3] FIG. 3 shows a side plan view of the flexible section and control section of the handheld medical endoscope of FIG. [Figure 4] FIG. 4 shows a front plan view of the control section of the handheld medical endoscope of FIG. [Diagram 5] FIG. 5 shows a bottom plan view of the control section and flexible section of the handheld medical endoscope of FIG. [Figure 6] FIG. 6 shows a side plan view of the control section and flexible section of the handheld medical endoscope of FIG. [Figure 7] FIG. 7 illustrates a top perspective view of the control unit of the portable medical endoscope of FIG. [Figure 8] FIG. 8 shows a side cross-sectional view of the control section of the handheld medical endoscope of FIG. [Figure 9] FIG. 9 shows a side cross-sectional view of the angulation mechanism in the controller handle of the handheld medical endoscope of FIG. [Figure 10] FIG. 10 shows a rear perspective view of the distal end of the flexible section of the portable medical endoscope according to this embodiment, with the distal tip bushing and curved rubber not shown. [Figure 11] FIG. 11 shows an exploded rear perspective view of the distal end of the handheld medical endoscope according to this embodiment, with the distal tip bushing and curved rubber not shown. [Figure 12] FIG. 12 shows a side view of the flexible portion of a handheld medical endoscope according to this embodiment, without showing the sheath (ie, outer covering) of the flexible portion. [Figure 13]FIG. 13 shows a rear perspective view of the distal end of the flexible portion of a handheld medical endoscope according to this embodiment, without showing the distal tip bushing, bending rubber and sheath. [Figure 14] FIG. 14 shows a front plan view of a detachable monitor of a portable medical endoscope according to this embodiment. [Figure 15] FIG. 15 shows a rear perspective view of the detachable monitor according to this embodiment. [Figure 16] FIG. 16 shows a perspective view of the front side of the detachable monitor according to this embodiment. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0028] The following detailed description is merely exemplary in nature and is not intended to limit the invention or the application and uses of the invention. Furthermore, there is no intention to be bound by any theory presented in the preceding background of the invention or the following detailed description. It is an object of the present embodiments to provide a low-cost, reusable, portable medical endoscope.

[0029] The present disclosure provides a portable medical endoscope, comprising: a flexible portion having a proximal end and a distal end, the flexible portion including a curved portion and a tip at the distal end, the tip including an imaging device; a control disposed at the proximal end of the flexible portion; and a detachable monitor configured to removably engage with the control; the control including: (i) an angulation mechanism coupled to the curved portion and the tip, the angulation mechanism controlling movement of the tip, and (ii) a handle in a pistol grip configuration, the flexible portion and the control being integrally formed, waterproof, and capable of withstanding high level disinfection conditions.

[0030] The device or endoscope of the present disclosure can be used for various endoscopic procedures, including but not limited to nasopharyngeal endoscopy, bronchoscopy, esophageal endoscopy, gastroscopy, or laryngoscopy. Alternatively, it can be used to view the inside of a body opening. Apart from cancer-related applications, applicable procedures include but are not limited to: pre- and post-operative airway endoscopy (PEAE), fiberoptic endoscopic evaluation of swallowing (FEES) for speech pathology, drug-induced sleep endoscopy (DIS) for sleep apnea, checking for velopharyngeal dysfunction (VPD), and post-operative examination after endoscopic sinus surgery (ESS).

[0031] 1 shows a side view of a handheld medical endoscope 100 (also known as an "endoscope" or "device") according to this embodiment. Flexible portion 102 is also known as the "flexible scope" or "flexible scope portion." Control portion 104 is also known as the "controller handle." In one embodiment, detachable monitor 106 is an LCD monitor.

[0032] FIG. 2 shows a front view of a portable medical endoscope 100 with a detachable monitor 106 attached.

[0033] An embodiment of the portable medical endoscope 100 without the detachable monitor 106 is shown in Figures 3 (left side view), 4 (front view), 5 (bottom view), and 6 (right side view).

[0034] Most reusable endoscopes in the prior art need to be connected to an endoscope stack to operate, limiting the portability of such prior art endoscopes. Advantageously, the medical endoscope of the present disclosure does not need to be connected to an endoscope stack and is used as a standalone device. The medical endoscope has a detachable monitor 106 that is detachable from the control unit 104, making the medical endoscope portable. A user can directly review photos and videos on the detachable monitor without extracting the data to a computer.

[0035] flexible part The flexible portion 102 is also known as a "flexible scope." As used herein, the term "scope" may be used interchangeably with "probe," "tube," or "insertion tube." Such a scope is useful for observing the inside of an orifice. In one embodiment, the flexible portion 102 is designed to have a small diameter of less than 4 mm, allowing for easy and comfortable insertion into a patient. The diameter of the flexible portion may range from 1 mm to 15 mm. In particular, in various embodiments, the tip of the flexible portion may have an outer diameter of about 3.5 mm. In various embodiments, the length of the insertion tube of the flexible portion 102 may be about 350 mm.

[0036] The flexible portion 102 is adapted to engage in a watertight manner with the control portion 104 or is integrally formed (i.e., formed as a single item) with the control portion 104. In a preferred embodiment, the flexible portion 102 is integrally formed with the control portion 104. Advantageously, once the detachable monitor 106 is removed, the flexible portion 102 and control portion 104 can be fully immersed in a fluid to provide a high level of disinfection, rendering the portable medical endoscope 100 reusable.

[0037] As shown in FIG. 10, the flexible section 102 includes a tip 1002 (also known as the "scope tip" or "flexible tip") connected at its distal end to a curved section 1004. The tip 1002 is covered by a distal tip bushing 1006. The tip 1002 is flexible, has an outer diameter of approximately 3.5 mm, and can be angled up to 150 degrees (300 degrees total) in two directions on a single plane, allowing the end user to comprehensively view the target body cavity region in a retroflex manner. This angulation is made possible by an angulation mechanism in the control section 104, which has two angulation wires 810 connected to two angulation stops 1104 (fixed to the distal tip bushing 1006 of the flexible tip 1002), as shown in FIG. 11. As shown in FIG. 12, the two angulation wires 810 are housed inside two wire coils 1204 that are used to guide the wires from the control section 104 to the flexible tip 1002. Advantageously, the angulation mechanism allows the user to control the orientation of the tip 1002.

[0038] In this embodiment, the curved section 1004 at the distal end of the flexible section 104 is designed to allow up to 100 bends per day for six consecutive months, for a total of over 18,000 bends. The bend of the curved section 1004 allows for angulation of the tip 1002. The curved section 1004 is also known as the "vertebrae" of the endoscope. Several metal bands are hinged in a vertebra-space-vertebra alternating manner. This configuration allows the vertebrae to move vertically and horizontally. The design of the curved section 1004 allows for low friction when moving in the intended plane, but high resistance when force is applied in a torsional motion, thus increasing the lifespan of the curved section 1004 compared to conventional rivet-style curved sections. Advantageously, the design of the curved section 1004 allows for increased bending cycles, durability, and reduced manufacturing costs.

[0039] As shown in FIG. 12, the flexure 1004 may be covered with a flexure rubber 1202 on the outside of the flexure. In addition to the design of the flexure 1004, the high durability of the flexure 1004 is also due to the materials used to manufacture the flexure 1004 and the flexure rubber 1202. In one embodiment, the flexure may be constructed from SUS631, a precipitation hardened stainless steel. This type of steel is known to offer significantly higher tensile and yield strengths compared to other types, such as austenitic stainless steels. In one embodiment, the flexure rubber 1202 is constructed from Viton™, a high performance fluoroelastomer polymer with high tensile strength and tear resistance.

[0040] Advantageously, using a high performance fluoroelastomer to form the curved rubber 1202 allows for increased durability (more bending cycles allowed), chemical resistance to high levels of disinfectant solutions, and increased flexibility of the curved rubber 1202. High performance fluoroelastomers are materials that are highly resistant to a wide range of chemicals and can withstand more disinfection cycles during reprocessing. This contributes to increased durability of the curved rubber 1202 and, therefore, the entire portable medical endoscope 100.

[0041] "Fluoroelastomer" is meant to include highly fluorinated polymers suitable for continuous use at high temperatures. Fluoroelastomers have excellent heat and flame resistance, and excellent resistance to aging, ozone, oxidizing agents, oils, and many chemicals. They also have low gas permeability and low compression set.

[0042] The tip may be made of stainless steel, such as SUS304. "SUS304" is meant to include "steel grade stainless steel" materials that contain chromium (approximately 18%-20%) and nickel (approximately 8%-10.5%) as the main non-ferrous components. It maintains good strength and heat resistance in high and low temperature environments, and also has good corrosion resistance, weldability, cold workability, and mechanical properties in mild environments.

[0043] The sheath of the flexible scope portion 102 is made of a biocompatible material to allow the device to be used in humans and is designed to be inserted into a patient's body cavity without causing injury or discomfort. Biocompatible materials do not cause toxicity or immune reactions in humans. Examples of biocompatible materials that can be used to make the sheath of the scope portion 102 include thermoplastic polyester elastomers (TPC), thermoplastic polyurethane elastomers (TPU), and polyvinyl chloride (PVC). The scope sheath may be composed of a blend of TPC and TPU, or a blend of TPC with TPU and soft PVC.

[0044] The tip 1002 includes an imaging device that includes an illumination source (such as one or more LED modules 1304 shown in FIG. 13), an image sensor (such as the CMOS sensor 1302 shown in FIG. 13), and an objective lens 1102 that allows for the capture of an image or video of the illuminated interior of the orifice or cavity under inspection. For example, a high resolution CMOS sensor 1302 may be housed behind the lens 1102 of the tip 1002, ensuring a clear field of view and allowing for easy identification of abnormal tissue features during screening. In various embodiments, surrounding the CMOS are high power, high color rendering index (CRI) and high R9 LED modules 1304 that allow the tip of the scope to emit sufficient light output at the tip 1002 of the flexible portion 102 to allow the end user to view the patient's tissue and ensure that the tissue is viewed with good quality light. This allows the user to better identify the tissue and make a faster and more accurate diagnosis. A suitable and sufficient heat sink or heat transfer system can be used to transfer the thermal energy from the tip 1002, for example, using a heat pip to transfer the thermal energy to the controller handle. Advantageously, the device of the present invention does not require a separate light guide or light source from the endoscope stack via the flexible section 102. Light guides are known to be more fragile and degrade during reprocessing and / or sterilization. On the other hand, the LED module 1304 of the tip 1002 is selected to have the following characteristics: high power, high color rendering index (CRI), and high R9 value to better highlight the tissue on which the camera is focused.

[0045] The flexible section 102 is designed and materials are selected to be waterproof and able to withstand long periods of harsh chemical high-level disinfection to prevent cross-contamination between patients after each use. Chemicals that can be used for high-level disinfection include, but are not limited to, glutaraldehyde, hydrogen peroxide, peracetic acid, and orthophthalaldehyde. Examples of trade names of commonly used high-level disinfectants that can be used with the device of the present invention include Cidex PLUS (glutaraldehyde), Cidex OPA (phthalaldehyde), Aldahol (glutaraldehyde), Rapicide (peracetic acid), Resert XL (hydrogen peroxide), and Acecide (peracetic acid and hydrogen peroxide).

[0046] The flexible section 102 is connected at a proximal end to a control section 104 .

[0047] Control Unit The control unit 104 is also known as a "controller handle." As shown in Figures 7-9, the control unit 104 includes a pistol grip 302 (also known as a "pistol grip configuration"), an angulation mechanism, a pressure valve 406, a tilt mechanism 404 for tilting the detachable monitor 106, a waterproof connector 402 for connecting to the detachable monitor 106, two buttons 306 for performing photo and / or video capture functions, and electronic components such as a camera driver module 820 and a backup battery 822.

[0048] The control unit 104 allows the end user to control the endoscope tip 1002 to achieve angulation of up to 150 degrees (300 degrees total) in two directions on a single plane, allowing the end user to better steer the endoscope tip 1002 in a desired direction during endoscopic introduction, while also providing comprehensive visualization within the targeted body cavity.

[0049] The control unit 104 is also designed and waterproof, and materials are selected in such a way that it can withstand long periods of harsh chemical high-level disinfection to prevent cross-contamination between patients after each use. "High-level disinfection" is meant to refer to any treatment of medical equipment or instruments that inhibits most viable microorganisms. Chemicals that can be used for high-level disinfection include, but are not limited to, glutaraldehyde, hydrogen peroxide, peracetic acid, and orthophthalaldehyde. Examples of trade names of commonly used high-level disinfectants that can be used with the device of the present invention include Cidex PLUS (glutaraldehyde), Cidex OPA (phthalaldehyde), Aldahol (glutaraldehyde), Rapicide (peracetic acid), Resert XL (hydrogen peroxide), and Acecide (peracetic acid and hydrogen peroxide).

[0050] The device itself is ruggedly designed and constructed to withstand operation in the field (outside a clinic environment).

[0051] In the majority of endoscopes, the handle of the control unit 104 is in the form of a conventional power grip. In the present invention, the handle includes a pistol grip configuration 302. The ergonomic design of the pistol grip 302 improves control and ease of use. Additionally, the pistol grip 302 may be more comfortable and intuitive for new users, thus encouraging adoption of the device. The non-slip texture on the bottom and top of the handle improves the grip when the end user grasps the endoscope 100. The control unit 104 is also designed so that the center of gravity of the control unit 104 sits nicely in the palm of the end user's hand to improve comfort when using the endoscope and when the detachable monitor 106 is plugged into the control unit 104. Additionally, the control unit 104 is designed to have a handle grip angle of 45-90 degrees to improve comfort and ease of use. The handle grip angle is the degree to which the pistol grip configuration 302 bends relative to a horizontal axis. In other words, it is the angle formed between the horizontal plane and the central axis of the pistol grip configuration 302. The combination of these features minimizes the ergonomic stress experienced by the user, especially during extended periods of device use.

[0052] The control 104 includes an intuitive, easy to use lever 304 on top of the pistol grip 302 to control the angle of the scope tip 1002 via a push-pull mechanism with the end user's fingers. As shown in FIGS. 8 and 9, the lever 304 is connected to a crankshaft 802, which is attached to two connector rods 804. Each connector rod 804 is fixed to a slide rod 806. Built into each slide rod are wire stops 808 and wire soldering rods 902. Angle wires 810 are attached to each wire stopper 808 and wire soldering rods 902. As a result, pulling or pushing the lever 304 moves the angle wires 810, thereby allowing the flexible tip 1002 to bend.

[0053] For example, pulling lever 304 actuates crankshaft 802, which moves connector rod 804, sliding rod 806, wire stop 808, and angulation wire 810 (in the order listed). When angulation wire 810 is connected to distal tip bushing 1006, pulling or pushing lever 304 bends curved section 1004, thereby angulating tip 1002. The degree of movement of the lever is proportional to the angle of deflection of tip 1002, with greater movement of lever 304 corresponding to greater angles of tip 1002. The movement of each sliding rod 806 is controlled by angulation base 812 and angle stop 814. Angulation base 812 and angle stop 814 have limited space for sliding rod 806 to move between them, and are therefore in position to allow lever 304 to push or pull angulation wire 810 up and down. In one embodiment, the angulation feature allows tip 1002 to be angulated up to 150 degrees in two directions (300 degrees total).

[0054] Advantageously, the angulation mechanism comprising the crankshaft 802 described herein allows for more stable movement of the angulation wire 810 during angulation of the tip 1002 and is therefore superior to existing angulation mechanisms including conventional pulley systems.

[0055] In one embodiment, the device also incorporates buttons 306 located on the control 104 for activating functions of the image capture device. "Activating a function" is meant to include activating a photo taking and / or video taking function. The buttons 306 can also be used to scroll through images or videos when accessed in playback mode. These buttons 206 can be used to simply activate taking photos or videos. All other functions during playback mode can be performed via the touch screen functionality of the monitor 106. Also, playback can be performed directly from the LCD monitor without retrieving the data to a PC, but retrieval can also be performed. For example, the button 306 can be located on the bottom of the pistol grip 302 for ease of use when an end user wishes to perform a photo taking and / or video taking function. The button 306 is embossed with three-dimensional "X" and "O" symbols to allow a user to tactilely distinguish between the photo taking button and the video taking button. It will be generally understood by those skilled in the art that the button 306 can be located elsewhere on the control 104.

[0056] The controller 104 includes a tilt mechanism 404 that allows the detachable monitor 106 to be tilted front to back to optimize the viewing angle when plugged into the controller 104. This tilt mechanism 404 allows the end user to easily change the viewing angle of the detachable monitor 106 to the most comfortable and ideal angle. The tilt mechanism 404 is controlled by a connector hinge 816 that is attached to a hinge retainer 818. The hinge retainer 818 determines the minimum and maximum tilt angle of the detachable monitor relative to the controller 104.

[0057] The controller handle is equipped with a pressure valve 406 that allows an end user to check the internal pressure within the control unit 104 before use. To check the internal pressure, the user connects a pressure pump to the control unit 104 and pumps air into the control unit 104 until a certain internal pressure is reached and leaves it for 2-3 minutes. In one embodiment, the internal pressure after pumping ranges from 140mmHg to 200mmHg. A subsequent stabilization of the pressure without a sudden drop in pressure indicates that the control unit 104 is leak-free. A drop in pressure indicates one or more leaks within the control unit 104.

[0058] The control unit 104 houses some of the electronic components, such as a camera driver module 820 .

[0059] The controller handle is also equipped with a waterproof connector 402, also known as a "female connector," which allows for a connection between the detachable monitor 106 and the control unit 104. This connector feature is designed to be waterproof. In particular, the female connector 402 is sealed to the controller handle, and the waterproofing is provided by the capping of the female connector 402. Furthermore, components such as O-rings are used to ensure a tight fit and waterproofing between the female connector 402 and the control unit 104. This allows the end user to immerse the control unit 104 in harsh chemicals for high-level disinfection purposes.

[0060] Detachable Monitor The detachable monitor 106 may be an LCD monitor. In the embodiment shown in Figure 14, the detachable monitor 106 includes an LCD monitor electronics housing 1402, an "on / off" button 1406, and a touch screen 1404. In the rear perspective view of the detachable monitor 106 shown in Figure 15, a waterproof connector 1502 is shown.

[0061] The detachable monitor 106 is constructed to incorporate touch screen functionality that provides ease of use to the end user as well as familiarity with the system. The end user can lightly touch with a finger or tap the screen while wearing gloves to activate various functions such as selecting to start a new scoping session, reviewing previously recorded media, or selecting a code name for the device, allowing the user to distinguish this particular device from others. The detachable monitor 106 also includes a connector 1502, also known as a "male connector" (shown in FIG. 15), which is adapted to mate with the female connector 402 on the control unit 104, allowing connection between the detachable monitor 106 and the control unit 104.

[0062] Advantageously, the detachable monitor 106 can be connected directly to the control unit 104 without the need for cables.

[0063] A signal from the camera module driver 820 is sent from the camera module driver 820 of the control unit 104 to a main board contained within the detachable monitor 106 and then to the monitor's screen 1404 where the image is displayed. Despite featuring a touch screen 1404, the detachable monitor 106 is also constructed to withstand wiping with an alcohol solution to prevent cross-contamination between patients after each use.

[0064] Apart from instantly displaying the live camera image on the planned compact 4 inch (or appropriate sized monitor such as 3.5 inch) built-in high resolution LCD monitor ("Live Mode"), the device is designed to incorporate media (photos and videos) recording and playback functionality ("Review Mode"). For clear visualization, the monitor resolution should be at least 400x400. This allows the clinician to later reassess or review the captured images / videos or share important findings after the procedure. The user can also easily switch between "Live" and "Review" modes. The media recorded by the device can also be transferred to a computer via USB, such as the USB port 1602 shown in Figure 16, for later viewing. The USB port 1602 may be a USB-C port for charging and data transfer / export.

[0065] White balance is important for an end user to effectively view a patient's anatomy during a scoping session. In the present invention, the white balance function is automated.

[0066] Overall, the device is constructed to include modular parts that can be easily removed and assembled up to 5000 times thanks to the intentional plug-and-play design mechanism between the detachable monitor 106 and the control unit 104. The term "plug-and-play" refers to the ability of the device to be ready to use upon initial connection without requiring reconfiguration or adjustment by the user. Such modularity also provides the user with flexibility in switching between different scopes (e.g., flexible scopes and sections, and handles) for different use cases and different models of screens as future generations become available. The detachable monitor 106 can be used with different versions of the control unit 104, which can be attached or connected to flexible sections 102 having different lengths, diameters of the tip 1002, etc., thereby providing the possibility to accommodate different surgical specialties other than head and neck cancer that can be used with the present invention. Also, advantageously, the present invention does not have any auxiliary devices (such as suction pumps or biopsy forceps). In other words, unlike conventional endoscopes, the device of the present invention does not have a "working channel" or lumen to accommodate auxiliary devices, making it easier to use and maintain, and easier to carry. There is no need for a reprocessing device to clean and disinfect the inside of the lumen of a conventional endoscope.

[0067] The detachable monitor 106 includes a rechargeable battery that allows the endoscope 100 to be used continuously for up to four hours, which is longer than the typical 30 minutes of use for similar handheld endoscopic devices in the prior art. Beneficially, the longer period of use per charge also increases the field suitability of the present endoscope 100. The endoscope 100 can be charged via a USB port 1602 on the detachable monitor 106. The device's battery life can be displayed on the monitor 106 to efficiently plan device usage.

[0068] conclusion It can thus be seen that the present disclosure provides a portable, low cost, reusable flexible medical endoscope.

[0069] Advantageously, the portable, low-cost, and reusable endoscope 100 of the present disclosure facilitates examination of patients by physicians in primary care settings in rural and regional hospitals, thus enabling early cancer diagnosis in less economically developed countries. Furthermore, the burden of patient care in national specialist hospitals will be significantly reduced, allowing a return of attention to conditions that truly require tertiary care (i.e., advanced cancers).

[0070] Additionally, the pistol grip 302 of the endoscope of the present disclosure is more ergonomic for the user compared to the conventional power grips present on the majority of endoscopes currently on the market. Additionally, the pistol grip 302 improves control and ease of use of the device. In particular, the pistol grip 302 is more comfortable and intuitive for new users. The pistol grip 302 is suitable when force is applied in the same direction as the extended forearm and wrist, as is the case with the endoscope of the present disclosure. The ergonomic advantage of the pistol grip 302 over the power grip can be attributed to the lower ergonomic stress required for supination of the pistol grip, the grip angle of the handle being 45-90 degrees, less force required to hold the endoscope, and also reduced force required to operate the control lever. Compared to the power grip, the use of the pistol grip 302 allows the flexible medical endoscope 100 to bend less and straighter during the examination. This potentially reduces friction between the endoscope 100 and the nasopharyngeal mucosa, allowing for more efficient operation of the endoscope 100.

[0071] Another important advantage is that the curved section 1004 at the distal end of the flexible section 102 is designed to withstand frequent bending without damage to the curved section 1004. This advantage of the curved section 1004 being highly durable is due in part to the materials used in the manufacture of the curved section 1004 and the curved rubber 1202. Thus, the medical endoscope 100 of the present disclosure can be reused multiple times before the curved rubber 1202 needs to be replaced. Also, the risk of fluid ingress through holes or tears in the curved section 1004 is minimized.

[0072] Another advantage of the endoscope of the present disclosure is that the materials used and the design of the outer portions of the flexible section 102 and control section 104 are waterproof and connected in a watertight manner, allowing the device to be subjected to a high level disinfection immersion during a reprocessing procedure. Thus, by removing the monitor 106 from the control section 104, the entire flexible section 102 and control section 104 can be immersed in a fluid to perform a high level disinfection. In contrast to single-use endoscopes where some parts must be made disposable because they cannot withstand the high level disinfection process, the endoscope 100 of the present disclosure can maintain its waterproof integrity and can be fully reprocessed after each use.

[0073] Although the embodiments of the present invention have been particularly shown and described with reference to certain embodiments, it should be understood by those skilled in the art that various changes in form and details can be made therein without departing from the scope of the present invention, as defined by the appended claims. The scope of the present invention is therefore indicated by the appended claims, and all changes that come within the meaning and range of equivalence of the claims are therefore intended to be embraced.

Claims

1. A portable medical endoscope, a flexible section having a proximal end and a distal end, the flexible section including a curved section and a tip at the distal end, the tip including an imaging device; a control portion disposed at the proximal end of the flexible portion; a detachable monitor configured to removably engage the control unit; and Including; The control unit (i) an angulation mechanism coupled to the bending section and the tip, the angulation mechanism controlling movement of the tip; and (ii) a handle in a pistol grip configuration Including, A portable medical endoscope, wherein the flexible section and the control section are capable of withstanding high-level disinfection conditions.

2. The portable medical endoscope according to claim 1, wherein the bending portion is made up of a plurality of vertebrae.

3. The handheld medical endoscopic device of claim 2 , wherein the plurality of vertebrae are connected to one another by hinges.

4. The portable medical endoscope according to claim 1, wherein the tip is made of stainless steel.

5. 5. The portable medical endoscope according to claim 4, wherein the stainless steel is SUS304.

6. The handheld medical endoscope of claim 1 , wherein the imaging device includes a complementary metal-oxide semiconductor (CMOS) sensor.

7. 2. The portable medical endoscope according to claim 1, wherein the bending portion is made of precipitation hardened stainless steel.

8. 8. The portable medical endoscope according to claim 7, wherein the precipitation hardening stainless steel is SUS631.

9. The portable medical endoscope according to claim 1, wherein the bending portion is covered with bending rubber.

10. 10. The portable medical endoscope according to claim 9, wherein the bending rubber is made of a high-performance fluoroelastomer.

11. 11. The portable medical endoscope of claim 10, wherein the high performance fluoroelastomer is Viton (trademark).

12. The portable medical endoscope according to claim 1 , wherein the control unit further comprises a pressure valve for measuring an internal pressure.

13. 2. The portable medical endoscope according to claim 1, wherein the detachable monitor is an LCD monitor.

14. The portable medical endoscope of claim 1 , wherein the detachable monitor includes a rechargeable battery.

15. The angle forming mechanism includes: a lever configured to control the angle of the tip; a crankshaft coupled to the lever and a pair of angle forming wires; Including, the pair of angulation wires extending from the control portion to the tip; The handheld medical endoscope of claim 1 , wherein displacement of the lever actuates the crankshaft to move the pair of angulation wires, thereby angulating the tip.

16. 2. The portable medical endoscope of claim 1, wherein the angulation mechanism allows the tip to be angulated up to 150 degrees in two directions in a single plane, for a total angulation of 300 degrees.

17. The handheld medical endoscope of claim 1 , wherein the flexible section and the control section are integrally formed to form a single article capable of withstanding high level sterilization conditions.

18. The handheld medical endoscope of claim 1 , further comprising one or more buttons disposed on the control unit for activating functions of the imaging device.

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