Examination device

Abstract

The present invention provides a two-part, single-use screening device comprising a high-resolution endoscopic camera and a single-use main body, the main body comprising: i) a handle portion for grasping; ii) a blade portion for introducing into a patient; and iii) a portion for detachably connecting to a mobile display device, the endoscopic camera being fixed within the main body, and the main body being made from a single material, the material being one of polyethylene, polypropylene, nylon, polystyrene, high impact polystyrene (HIP), polyurethane, polycarbonate, acrylonitrile butadiene styrene, thermoplastic elastomer, acrylic, or polyester.

Description

[Technical Field]

[0001] The present invention relates to a two-part, single-use screening device. [Background technology]

[0002] Best clinical practice requires direct visualization of medical procedures when needed. In the healthcare market, this requires expensive visualization methods with expensive consumables, overly complex infection control measures including sterilization, and a separate battery source that must be disposed of.

[0003] One area of clinical use is in video laryngoscopy as a medical procedure to assist with tracheal intubation. Video laryngoscopy monitors typically contribute significantly to the overall cost of anesthesia, as do video laryngoscopy consumables.

[0004] A 2018 policy statement from the Association of Anaesthetists of Great Britain and Ireland advises videolaryngoscopy wherever possible. Despite best practice, evidence demonstrates that videolaryngoscopy accounts for 8% of general anaesthesia procedures and incurs excessive and escalating recurring consumable costs.

[0005] U.S. Patent No. 6,269,949 discloses a video laryngoscopy accessory for a mobile communication device. While U.S. Patent No. 6,269,949 states that the accessory is single-use, the material of the accessory's body must be sterilizable and durable for reuse. Furthermore, the described device is not only made of multiple components, but also has many moving parts, making it prone to breakage. [Prior art documents] [Patent documents]

[0006]

Patent Document 1

Summary of the Invention

Problems to be Solved by the Invention

[0007] Therefore, there is a need to provide a device for visualizing a medical examination that is easy to use and manufacture, more cost-effective and efficient, and highly resistant to damage.

Means for Solving the Problems

[0008] The present invention is a single-use medical examination device consisting of two parts, a high-resolution endoscope camera and a single-use body and is provided with The body i) a handle part for gripping, ii) a blade part to be introduced into a patient, iii) a part detachably coupled to a mobile display device and is provided with [[ID=No. 35]]The endoscope camera is fixed within the body, the body is made of a single material, and the material is one of polyethylene, polypropylene, nylon, polystyrene, high-impact polystyrene (HIP), polyurethane, polycarbonate, acrylonitrile-butadiene-styrene, thermoplastic elastomer, acrylic, or polyester, to provide a medical examination device.

Brief Description of the Drawings

[0009]

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DETAILED DESCRIPTION OF THE INVENTION

[0010] The present invention relates to an endoscope provided with a high-resolution camera and coupled to a mobile device to display real-time patient images (still images or live videos) near the surgeon's line of sight. The present invention is presented as a disposable body, which includes a portion detachably coupled to a mobile device that firmly holds the mobile device in place. The body of the present invention defines a channel for fixing the camera in a contamination-free environment and optimizing the camera position according to the organ to be examined.

[0011] The benefits of arranging all components in this way are characterized by low cost and minimal environmental impact. In particular, being a metal-free disposable body provides advantages in terms of waste disposal by offering a single stream of material waste. This enables mass disposal or reuse of the body, thus allowing for clear cost reduction and increased control over environmental impact. Also, the property of being metal-free has been found to mean that the product is lighter, does not interfere with any other medical devices during use, and avoids conduction or radiation side effects. Therefore, the device is easier and safer to use during operation.

[0012] The device may be suitable when examination and image recording are required. The device is preferably an otoscope, laryngoscope or proctoscope, or other device for examining the nose, stomach, bronchus or sigmoid colon. The device can be used not only for human examinations but also for veterinary examinations of animals.

[0013] The endoscope camera of the present invention has a high resolution, and thus is 1k or more. The resolution is preferably in the range of 1k to 2k, and most preferably 1.5k. For example, a resolution of 4k or more is more costly while having limited additional sharpness. As a result, the manufacturing cost of the device is reduced overall. Also, the camera lens is preferably polished and less than 1 mm thick to prevent refraction of image transfer.

[0014] The camera is preferably connected to the mobile display device by a cable and housed within the main body of the device. The length of the cable varies according to the procedure. The connection between the camera and the mobile display device is preferably a USB connection, such as mini USB, micro USB, USB C type or Lightning type. The camera is preferably powered by the mobile display device, and most preferably by the mobile display device only. Thus, this eliminates the need for other power sources such as batteries. The presence of other power sources not only increases costs but also brings about the issue of disposing of those power sources themselves. For this reason, the present invention can meet the requirements of the Waste Electronic and Electrical Equipment (WEEE) guidelines regarding battery waste and EU laws.

[0015] The camera preferably includes an integrated light ring surrounding the camera lens. An unexpected benefit of such a feature is that the heat generated by the LED ring is low, eliminating the need for anti-fogging and removing the need for a lens cover incorporated into the body, i.e., no separate lens cover for the camera is required. Thus, it is preferable that there is no additional barrier between the camera and the patient. The additional barrier may impair the fidelity of the displayed image. This is a further advantage of the present invention.

[0016] The single-use body of the present invention comprises a handle portion for gripping, a blade portion for introduction into a patient, and a portion for separably coupling to a mobile display device. As described, the metal-free body provides a lighter, easier and safer device to dispose of or reuse, minimizing the risk of interference with other medical devices during use. The body is preferably made from one of polyethylene, polypropylene, nylon, polystyrene, polyurethane, polycarbonate, acrylonitrile butadiene styrene, thermoplastic elastomer, acrylic, or polyester. Most preferably, the body is made entirely from polyethylene or polypropylene or polystyrene or high impact polystyrene (HIP), and thus is simple to manufacture, inherently clinically clean (i.e., free of foreign matter, dust and grease), and easy to dispose of or reuse. The inventors have understood that by using only one material, a smoother surface is provided for all areas that may come into contact with the patient, and thus patient discomfort is minimized. Surgery and subsequent mobile display visualization are also less likely to be interfered with or affected due to the uniformity of the materials used. Due to the uniformity of the inclusions, unexpectedly, a single material provides a more rigid device. Polypropylene, especially medical grade polypropylene such as Bormed™, is the most preferred single material for the present invention.

[0017] Typically, the body has no moving parts when two parts of the body are fixed together, and the blade is typically integrated with the handle portion, although in one embodiment the blade may be separable. The body comprises two halves connected by a hinge, which become non-movable when closed. Additionally or alternatively, the two halves can be press-fitted or snap-fitted together. The body can also comprise a double wall of tongue-and-groove seals that form an internal channel for housing an endoscope camera and cable within a non-infected cavity. Such a structure simplifies the manufacture of the body, increases its strength during construction and use, and makes it less prone to breakage.

[0018] The handle part preferably has a ribbed structure, and more preferably has an internal ribbed structure with finger grooves to make it easier for the user to grip. The ribbed handle part increases the operability and stability of the device during examination. Also, the blade part can have a thinner profile at the tip. In other words, the profile widens from the tip of the blade part upwards or in the middle or central section. This also contributes to the technical effects specified above. The ribs of the present invention are structured and positioned to optimize the strength of the device and minimize its weight. The selected density of the ribs at the angle between the blade part and the handle part results in the unexpected benefit of giving the device a maximum breaking strain and removing the risk of breaking during normal use for both the user and the patient. Preferably, there are 10 to 25 ribs, and more preferably 14 to 20 ribs.

[0019] To find the breaking point, the ribbed body shown was tested. In this case, the breaking point was determined by either the breakage or disengagement of the clip elements holding the body together. The maximum applicable force was about 192 Newtons. At this force, the device did not break. Rather, the device became unusable. A standard laryngoscope can withstand a maximum force of 150 Newtons according to international standards such as ISO 7376. Therefore, this is an unexpected benefit due to the ribbed structure providing a significantly greater special strength than current market models.

[0020] For the most effective use and patient safety, the body preferably has a minimum breaking load within the range of 150 to 300 Newtons, preferably greater than 150 Newtons (i.e., can withstand up to a maximum of 150 Newtons), and more preferably greater than 190 Newtons, and / or the maximum mass of the body is preferably 75 g or more preferably 55 g. The maximum mass of the body can be 100 g or less, for example 75 g or less, or 55 g or less. A preferred range is, for example, 40 g to 60 g.

[0021] The blade can be of any suitable size, including sizes suitable for pediatric or small adult use.

[0022] The main body of the device further comprises a part detachably coupled to the mobile display device. This part preferably includes an integral clip that enables the display device to be securely held against a recess in the head of the device. Such a spring clip or bracket holder can be provided with notches to accommodate mobile display devices of various sizes or various depth positionings. Otherwise, the clip can be a press clip that presses against a corresponding part of the mobile phone to fix its positioning. In one embodiment, such a clip can be an integral part or a separate part.

[0023] The mobile display device according to the present invention is preferably a mobile phone or a tablet. Such a display device is preferably provided throughout the device of the present invention, so that the end user does not need to use their own device. This maintains not only a medically sterile environment but also ease of use in combination with consumer-friendly devices. The device preferably complies with safety compliance standards such as IEC 60601.

[0024] Due to the versatility of the mobile device, the direct user familiarity is ensured, and the ease of learning is improved, thus reducing the risk of patient error during use. It is preferably capable of running an application (an "app"). The mobile display device can be supplied with a pre-loaded application to transmit images to the screen of the display device and perform image data processing to compile contour and boundary definitions along with environmental recognition of signpost surveys or intubation landmarks provided by the image data stream. Additional features can include schematic usage instructions and training videos. The application can also provide a function to synchronize data and attach it to patient and hospital records.

[0025] The display device displays indirect images from information collected and transferred by the lightning connector / USB or other ports of the electronic endoscope. The display device preferably does not have a SIM card for preventing phone use and for protecting patient confidentiality. The mobile phone is preferred for its optimal screen size and resolution, familiarity and ease of use with applications, cost-effectiveness, and continuous progress for clinical analysis. Generally, this enables real-time patient analysis and clinical interpretation of images, or recording for subsequent analysis or attachment to patient records. The present invention is lightweight and portable, intuitive with simple instructions, and provides ease of use. The present invention emphasizes the interactive embodiment that travels between direct vision and indirect vision, between adjacent display screens and remote display screens, or the embodiment that does not interfere with the position of the hand on the grip, thereby further eliminating the need for embodiments that compromise controllability.

[0026] The mobile display device can be used not only to provide images but also to record sound. Therefore, it is beneficial for the mobile display device to provide the ability to monitor the comments made by the surgeon and the ambient sound. In this regard, the user of this device is given the ability to take voice memos during the progress of the examination. In addition, the user can record a voice memo after the examination to, for example, summarize the examination or identify areas for improvement for future examinations. In this way, the surgeon is provided with a way to continuously monitor the procedure and identify potential improvements to the examination device. This feature of voice recording does not exist in the devices currently on the market and is a feature of using a mobile communication device as a display element of the video laryngoscope system according to the present invention.

[0027] Generally, the device of the present invention provides a balanced center of gravity. This is in contrast to relatively large and bulky devices on the market where the center of gravity during use makes the operation of the line of sight more difficult than conventional devices. Embodiments of the present invention demonstrate that when operating the blade and performing lateral articulation from an initial insertion into the patient site for examination to the final blade position for patient examination or intubation assistance, the screen is positioned near the surgeon's line of sight and is configured at an acute angle to the vertical line to optimize the surgeon's visibility since the examination site is unavoidably lower than the surgeon. The present invention optimizes simplicity during the procedure. The portion detachably coupled to the mobile display device is preferably configured to be centrally coupled to the mobile display device, i.e., such that the mobile display device is held in a central position, as shown, for example, in FIGS. 1 and 4 - 7. A typical laryngoscope device has a right - hand bias or a left - hand bias. By positioning the display device at the center of the line of sight, the display can be suitable for use with either the left hand or the right hand.

[0028] The drawings of the present invention show various views of the device according to the present invention, and the device comprises a main body having a ribbed handle portion 1, a blade portion 2, and a coupling portion 4 detachably coupled to a mobile display device 5. The main body houses an endoscope and a high - resolution camera 3, and a cable connects the main body to the mobile display device 5. The cable terminates with a molded housing that positions the endoscope camera in place for optimal visibility and is covered by a sealed lens to maintain the contamination risk at zero.

[0029] FIG. 3 shows the device in the open position, where the two halves of the main body of the device can be opened to safely remove the endoscope camera and the cable before disposal of the main body. When the two halves are closed, the cable and the endoscope camera are housed in a sealed and contamination - free environment.

[0030] Figure 4 shows a size-adjustable integrated spring clip that enables the use of mobile display devices of various sizes or the change of the depth positioning of a mobile phone by using the illustrated notch. The spring clip is configured at an acute angle with respect to the vertical line so as to optimize the visibility of the surgeon, since the investigation site inevitably lies lower than the surgeon. Figure 5 shows a spring clip or a bracket holder attachment mechanism. Figure 6 shows a press clip attached to the back of the mobile display device, and the clip itself can be a separate separable clip. Figure 7 shows a press clip attachment mechanism.

[0031] Figures 8A to 8D and Figures 9A to 9C respectively show various perspective views of the rectoscope device and the otoscope device according to the present invention, and also clearly show the advantageous ribbed body structure, the clip fitting mechanism for attaching a mobile phone, and the integrated housing mechanism for an endoscope. In order to maintain the disclosure matters at the time of the original filing of this application, the descriptions of claims 1 to 17 at the time of the original filing of this application are added below. (Claim 1) A single-use diagnostic device comprising two parts, a high-resolution endoscope camera, and a single-use main body and is provided with, wherein the main body i) a handle part for gripping, ii) a blade part to be introduced into the patient, iii) a part detachably coupled to a mobile display device and is provided with, the endoscope camera is fixed within the main body, the main body is made of a single material, and the material is one of polyethylene, polypropylene, nylon, polystyrene, high-impact polystyrene (HIP), polyurethane, polycarbonate, acrylonitrile butadiene styrene, thermoplastic elastomer, acrylic, or polyester, a diagnostic device. (Claim 2) The device according to claim 1, which is a laryngoscope, a proctoscope or an otoscope. (Claim 3) The single material is one of polyethylene, polypropylene, polystyrene or high-impact polystyrene (HIP), preferably polypropylene, more preferably Bormed polypropylene, the diagnostic device according to claim 1 or 2. (Claim 4) The display device is a mobile phone or a tablet capable of running an application, and preferably, the display device is provided on the diagnostic device, the diagnostic device according to any one of claims 1 to 3. (Claim 5) The main body is provided without moving parts, the diagnostic device according to any one of claims 1 to 4. (Claim 6) The main body is provided with two halves connectable by a hinge, the diagnostic device according to any one of claims 1 to 4. (Claim 7) The main body is provided with two halves press-fitted or snap-fitted together, the diagnostic device according to any one of claims 1 to 5. (Claim 8) The part detachably coupled to the mobile display device includes an integrated clip, the diagnostic device according to any one of claims 1 to 7. (Claim 9) The endoscope camera is provided with an integrated light ring surrounding the camera lens, the diagnostic device according to any one of claims 1 to 8. (Claim 10) The display device is the only power source for the endoscope camera, the diagnostic device according to any one of claims 1 to 9. (Claim 11) The inspection device according to any one of claims 1 to 10, wherein the main body includes internal structure ribs therein, and the ribs are positioned to optimize the strength of the device. (Claim 12) The inspection device according to claim 11, wherein the main body has a minimum breaking load within the range of 150 N to 300 N, preferably greater than 190 N. (Claim 13) The inspection device according to any one of claims 1 to 12, wherein the maximum mass of the main body is 100 g or less, preferably 75 g or less, and preferably 55 g. (Claim 14) The inspection device according to any one of claims 1 to 13, wherein the device includes a double wall of a bellows seal that forms an internal channel for accommodating the endoscope camera and the cable within a non-infected cavity. (Claim 15) The inspection device according to any one of claims 1 to 14, wherein the camera does not include an additional barrier between the camera and the patient. (Claim 16) The inspection device according to any one of claims 1 to 15, wherein the portion detachably coupled to the mobile display device is configured to be coupled to the mobile display device at the center. (Claim 17) The inspection device according to any one of claims 1 to 16, wherein the mobile display device is configured to simultaneously capture audio recording in addition to recording an image.

Claims

Claim 1. A disposable diagnostic device, comprising: A disposable main body, The main body includes: i) A handle part for gripping; ii) A blade part to be introduced into a patient; iii) A part detachably coupled to a mobile display device, the part detachably coupled to the mobile display device including an integrated clip; And is provided with, The main body is configured to accommodate a high-resolution endoscope camera, and the main body is made of a single material including polyethylene, polypropylene, nylon, polystyrene, high-impact polystyrene (HIP), polyurethane, polycarbonate, acrylonitrile butadiene styrene, thermoplastic elastomer, acrylic, or polyester. The main body includes two halves connected by a hinge, or two halves press-fitted or snap-fitted together. Diagnostic device. Claim 2 The diagnostic device according to claim 1, wherein the device is a laryngoscope, a proctoscope, or an otoscope. Claim 3 The diagnostic device according to claim 1, wherein the polypropylene is Bormed polypropylene. Claim 4. The diagnostic device according to any one of claims 1 to 3, comprising a mobile display device. Claim 5 The diagnostic device according to claim 4, wherein the mobile display device is a mobile phone or a tablet capable of running an application. Claim 6. The diagnostic device according to any one of claims 1 to 3, comprising a high-resolution endoscope camera. Claim 7 The diagnostic device according to any one of claims 1 to 6, wherein the main body does not include movable parts. Claim 8 The diagnostic device according to claim 6, wherein the endoscope camera includes an integrated light ring surrounding the camera lens. Claim 9 The diagnostic device according to claim 6, which quotes claim 4, wherein the mobile display device is the only power source for the endoscope camera. Claim 10 The diagnostic device according to any one of claims 1 to 9, wherein the main body includes internal structure ribs therein, and the ribs are positioned to optimize the strength of the device. Claim 11 The diagnostic device according to claim 10, wherein the main body has a minimum breaking load greater than 190 Newtons within the range of 150 Newtons to 300 Newtons. Claim 12 The diagnostic device according to any one of claims 1 to 11, wherein the maximum mass of the main body is 100 g or less, 75 g or less, or 55 g or less. Claim 13 The inspection device according to any one of claims 1 to 12, comprising a double wall of a bellows seal that forms an internal channel for housing the endoscope camera and the cable in a non-infected cavity.

14. The inspection device according to any one of claims 1 to 13, wherein the endoscope camera does not have an additional barrier between the camera and the patient.

15. The inspection device according to any one of claims 1 to 14, wherein the portion detachably coupled to the mobile display device is configured to be coupled to the mobile display device at the center.

16. The inspection device according to any one of claims 1 to 15, wherein the mobile display device is configured to simultaneously capture audio recording in addition to recording an image.

Images