Automatic mydriasis device, mydriasis method and mydriasis effect detection method

Abstract

The invention provides an automatic mydriasis device. The automatic mydriasis device comprises a head-mounted structure, and an eyedrop spraying system, an audio and video guiding unit and an image analysis system which are mounted on the head-mounted structure, the head-mounted structure covers the eyes to form a darkroom, and the audio and video guide unit guides the eyes to open, rotate or close; the eyedrop spraying system sprays eyedrops to eyeballs according to set time and dosage; the image analysis system is used for shooting images of eyeball shapes and movement, controlling the audio and video guide unit and the eyedrop spraying system to work according to system settings, spraying eyedrops, and judging the pupil diffusion effect through image recognition under the guidance of sound and images by the audio and video guide unit. The invention further provides a mydriasis method adopting the automatic mydriasis device and a mydriasis effect detection method.

Description

Technical Field

[0001] The present invention relates to the technical field of ophthalmic medical devices and methods, and more precisely, to an automatic mydriasis device and method based on acousto-optic guidance. Background Art

[0002] Mydriasis is required during medical optometry, fundus examination, and diagnosis and treatment of eye diseases. Mydriasis, also known as dilated pupil examination, refers to dilating a person's pupil by dropping eye drops. The ciliary muscle of the eye is in an anesthetic state under the action of the drug. After mydriasis, it is convenient for doctors to examine the fundus, observe the inside of the eyeball, and more accurate refractive degrees can also be obtained, thereby improving the accuracy of glasses fitting.

[0003] The traditional method of mydriasis is to use eye drops. Medical staff rely on experience to open the patient's eyelids every 3 - 10 minutes and drop eye drops such as tropicamide into the eyes. During this period, the patient closes their eyes and rests. About 20 - 30 minutes after multiple drops of eye drops, the medical staff observes whether the iris ciliary muscle of the patient relaxes and whether the pupil dilates. The traditional manual operation method of dropping eye drops depends on factors such as the experience, responsibility, and communication with the patient of the medical staff. The time of dropping eye drops cannot be precisely controlled, and medical staff are prone to delay or forget to drop eye drops when busy; in addition, the dosage of eye drops dropped manually is uncontrollable, completely relying on the experience of medical staff, and the eye drops are dropped in the form of water droplets and are difficult to spread evenly on the eyeball after dropping; after the eye drops are dropped into the eyes, the patient needs to close their eyes first and then move the eyeball to make the eye drops spread evenly, and the spreading effect cannot be monitored and controlled; the mydriasis effect needs to be judged by medical staff according to experience, and there may be a situation where repeated mydriasis is required due to differences in judgment criteria among different personnel.

[0004] Currently, there is also a mechanical mydriasis method in this field. Using a pupil dilation device for mechanical mydriasis can provide a better view of the inside of the eye for ophthalmologists, but the mechanical mydriasis method requires implanting the mydriasis device into the eyeball and is only applicable during surgery and not for general ophthalmic examinations.

[0005] In summary, this field needs an automatic mydriasis device and method that is applicable to general ophthalmic examinations and does not rely on manual operation and judgment. Summary of the Invention

[0006] In view of this, the purpose of the present invention is to provide an automatic mydriasis device, a mydriasis method, and a mydriasis effect detection method. Before mydriasis, the patient wears a mydriasis device with a dark room physical space and an eye drop spraying function. Through voice prompts and image guidance, the eye drops are automatically sprayed, and the mydriasis effect is automatically judged. There is no need for medical staff to drop eye drops and subjectively judge the mydriasis effect. Moreover, the automatic mydriasis device can remove the automatic eye drop spraying system and can be used alone as an automatic mydriasis effect detection device.

[0007] To achieve the above object, the present invention provides an automatic mydriasis device, comprising a head-mounted structure and an eye drop spraying system, an audio-visual guiding unit, and an image analysis system mounted on the head-mounted structure; the head-mounted structure covers the eyes to form a dark room, and the audio-visual guiding unit guides the eyes to open wide, rotate or close; the eye drop spraying system sprays eye drops on the eyeball according to the set time and dose; the image analysis system takes images of the shape and movement of the eyeball, and controls the operation of the audio-visual guiding unit and the eye drop spraying system according to the system settings, performs the action of spraying eye drops, and judges the pupil dilation effect through image recognition under the guidance of sound and image by the audio-visual guiding unit.

[0008] Preferably, the audio-visual guiding unit includes an image display unit, and the image display unit displays picture and video information according to the preset scene according to the time of spraying eye drops, and guides the patient's eyes to close, rotate and open wide following the scene.

[0009] Preferably, the audio-visual guiding unit includes a voice playback unit, which plays pre-stored voices according to the instructions of the automatic control module to guide the patient's eyes to perform actions such as closing, rotating and opening wide.

[0010] Preferably, the eye drop spraying system is composed of an eye drop nozzle, a spraying electric pump, an eye drop storage unit and a control and analysis unit. The eye drop nozzle and the spraying electric pump, and the spraying electric pump and the eye drop storage unit are respectively connected by hoses; the spraying electric pump and the control and analysis unit are electrically connected by wires, and the control and analysis unit controls the rotation speed, the start time and the end time of the work of the spraying electric pump.

[0011] Preferably, the image analysis system takes a video of the eyeball within a specified time through a camera, extracts typical pictures from the continuous video, and analyzes the pupil diameter.

[0012] Preferably, the control and analysis unit includes a signal input unit, a data storage unit, a calculation and analysis unit, and an output unit. It recognizes the shape and movement of the eyeball according to the image of the camera, drives the image display unit and the sound device to guide the movement of the eyeball, controls the eye drop spraying module to spray eye drops, and judges the pupil dilation effect by using image recognition.

[0013] Preferably, the head-mounted structure is composed of a device housing, a dark room flexible material, a retractable fastening belt and a fastening belt retraction adjustment mechanism. The dark room flexible material and the retractable fastening belt are integrally mounted on the device housing, and the fastening belt retraction adjustment mechanism is integrally provided on the retractable fastening belt; the device housing covers around the eyes through the dark room flexible material, and the retractable fastening belt is fixed around the head.

[0014] The present invention provides an automatic mydriasis method. Using the automatic mydriasis device, the method includes the following steps:

[0015] (1) Before mydriasis, medical staff assemble eye drops and set the spraying time, the dosage per spraying, the eye-closure time per spraying, the voice and images for guiding eye movement through a wired / wireless data interface;

[0016] (2) The patient wears the mydriasis device, and the image acquisition unit takes pictures of the eye shape and identifies the pupil size. The images and their analysis data are stored in the control and analysis module;

[0017] (3) Using the voice and images of the automatic mydriasis device, guide the patient's eye movement, eye opening, eye closing and other actions, and spray the eye drops according to the set time and dosage;

[0018] (4) After all the times and dosages of spraying eye drops are completed, use the camera to take pictures of the eye shape and pupil size to identify the mydriasis effect;

[0019] (5) Use voice to inform the patient that the mydriasis is over. The patient removes the mydriasis device, and the medical staff transmits data such as the mydriasis patient information and the mydriasis effect to the data platform of the medical staff through a wired / wireless data interface.

[0020] The present invention provides a method for detecting mydriasis effect. Using the automatic mydriasis device, the method includes the following steps:

[0021] (1) Before mydriasis, the patient wears the mydriasis device, and uses voice and images to induce the eyes to open wide. The camera takes pictures of the eye shape and identifies the pupil diameter D0;

[0022] (2) After mydriasis, use voice and images to induce the eyes to open wide. The camera takes pictures of the eye shape and identifies the pupil diameter D1;

[0023] (3) Judge whether the pupil diameter before and after mydriasis is greater than the set value ΔD5, D1 - D0 ≥ ΔD5? If the pupil diameter before and after mydriasis is less than the set value and the set mydriasis effect is not achieved, it is necessary to continue spraying eye drops for mydriasis; if the pupil diameter before and after mydriasis is not less than the set value, it is necessary to detect whether the pupil retracts under strong light irradiation;

[0024] (4) The image display unit emits light with a specified brightness, and the camera takes pictures of the eye shape and identifies the pupil diameter D3;

[0025] (5) Judge whether there is a change in the pupil diameter after strong light irradiation, and the change value is less than the set value ΔD6? |D2 - D3| ≥ ΔD6; if the change value of the pupil diameter after strong light irradiation is not greater than the set value, the pupil diameter meets the mydriasis requirement and the pupil does not retract after light irradiation, and the mydriasis is successful; if the change value of the pupil diameter after strong light irradiation is less than the set value, the set mydriasis effect is not achieved.

[0026] Preferably, one of the following two methods is used to evaluate the mydriatic effect:

[0027] (1) Judgment method: achieving mydriatic effect, not achieving mydriatic effect;

[0028] (2) Quantitative scoring method: α = ((D1 - D0) ÷ ΔD5 × k1 + |D2 - D3| ÷ ΔD6 × k2) × 100%; where α is the percentage of the mydriatic effect evaluation index; D0 is the pupil diameter before mydriasis; D1 is the pupil diameter after mydriasis; D3 is the pupil diameter under strong light irradiation after mydriasis; ΔD5 is the set value of the change in pupil diameter before and after mydriasis; ΔD6 is the set value of the change in pupil diameter under strong light irradiation after mydriasis; k1 and k2 are correction values.

[0029] Compared with the prior art, the advantages of an automatic mydriatic device, a mydriatic method, and a mydriatic effect detection method disclosed by the present invention are as follows: The automatic mydriatic device can automatically spray eye drops, replacing manual operation. The control of the time and dose of eye drops entering the eye is more accurate, and there will be no delays or omissions. The method of spraying eye drops onto the surface of the eyeball is more conducive to pupil dilation than the dropping method, and the mydriatic effect is better. During the mydriatic process, the automatic mydriatic device uses voice and video to guide the patient to perform actions such as closing the eyes and rotating the eyeballs, with better mydriatic interactivity. It can also play voice and video information to prevent the patient's actions or behaviors from getting out of control during the waiting process. By using an image recognition method through a camera to detect the change in pupil diameter and whether the pupil retracts under strong light, the system automatically controls and calculates the mydriatic effect, with comprehensive inspection and high automation. The evaluation index is set according to the diameter of the pupil before mydriasis, which can avoid the deviation of the judgment scale in manual inspection. BRIEF DESCRIPTION OF THE DRAWINGS

[0030] In order to more clearly illustrate the technical solutions in the embodiments of the present invention or the prior art, the following will briefly introduce the drawings required for use in the description of the embodiments or the prior art. Obviously, the following drawings are only some embodiments of the present invention. For those of ordinary skill in the art, other drawings can be obtained based on these drawings without creative efforts.

[0031] As Figure 1 shown is a schematic structural diagram of an automatic mydriatic device of the present application.

[0032] As Figure 2 shown is a schematic flow diagram of a mydriatic method of the present application.

[0033] As Figure 3 shown is a schematic flow diagram of a mydriatic effect detection method of the present application.

[0034] In the figure, 101 - device housing; 102 - light - proof flexible material; 103 - retractable fastening strap; 104 - fastening strap retraction adjustment mechanism; 221 - battery; 222 - eye drop nozzle; 223 - control and analysis unit; 224 - image acquisition unit; 225 - voice playback unit; 226 - spraying electric pump; 227 - eye drop storage unit; 228 - image display unit. Detailed implementation manners

[0035] Next, the technical solutions in the embodiments of the present invention will be clearly and completely described in conjunction with the accompanying drawings in the embodiments of the present invention. Obviously, the described embodiments are only a part of the embodiments of the present invention, rather than all the embodiments. All other embodiments obtained by those of ordinary skill in the art based on the embodiments of the present invention without making creative efforts belong to the scope of protection of the present invention.

[0036] As Figure 1 shown, an automatic mydriasis device of the present application includes a head - mounted structure, and an eye drop spraying system, an audio - visual guiding unit, and an image analysis system are integrally installed at corresponding positions of the head - mounted structure; the head - mounted structure includes a device housing 101, a light - proof flexible material 102, a retractable fastening strap 103, and a fastening strap retraction adjustment mechanism 104; the eye drop spraying system is composed of an eye drop nozzle 222, a spraying electric pump 226, an eye drop storage unit 227, and a control and analysis unit 223, and is used for storing eye drops and spraying eye drops onto the eyeball at a specified time and dose; the audio - visual guiding unit is composed of a voice playback unit 225, an image display unit 228, and a control and analysis unit 223, and can play voice and images at a specified time to guide the movement or closure of the eyeball, and can also detect whether the pupil shrinks after mydriasis by emitting strong light through the display; the image analysis system is composed of an image acquisition unit 224 and a control and analysis unit 223, and can take videos of the eyeball, identify the pupil diameter by using image analysis methods, and determine the mydriasis effect.

[0037] Specifically, a light - proof flexible material 102 and a retractable fastening strap 103 are integrally installed on the device housing 101, and a fastening strap retraction adjustment mechanism 104 is provided on the retractable fastening strap 103. The device housing 101 covers the periphery of the patient's eyes through the light - proof flexible material 102, and the retractable fastening strap 103 surrounds the patient's head for fixation. After the patient wears the device, a light - proof chamber is adjusted through the fastening strap retraction adjustment mechanism 104 to prevent external light from entering, increasing the immersive scene effect of the image display.

[0038] Specifically, in this embodiment, the device housing 101 is preferably made of carbon fiber material to reduce the structural weight and improve the comfort of the patient's wearing. The light-tight flexible material 102 is preferably made of silicone rubber (SiR), processed by hollow foaming, and molded according to the shape of the forehead, the size of the nose bridge, etc., to improve the adaptability to the human face, further improve the wearing comfort, and reduce the light leakage at the same time. The retractable fastening band 103 is made of hydrogenated butyl rubber material (HXNBR) to ensure the anti-tensile effect. Preferably, there is 1 longitudinal rack every 3 mm on the retractable fastening band 103, which can adjust the length of the fastening band when the fastening band telescopic adjustment mechanism 104 rotates. The fastening band telescopic adjustment mechanism 104 is made of plastic material, and can adjust the length of the retractable fastening band 103 by rotation. The maximum adjustable length is 72 mm. By adjusting the length, the pulling force during wearing can also be adjusted to avoid discomfort caused by being too tight, meeting the wearing requirements of different head sizes from children to adults.

[0039] In this embodiment, the eye drop nozzle 222 of the eye drop spraying system is connected to the spraying electric pump 226 and the spraying electric pump 226 is connected to the eye drop storage unit 227 through hoses respectively, and the eye drops can flow in the hoses. The spraying electric pump 226 is electrically connected to the control and analysis unit 223 through a wire, and the control and analysis unit 223 controls the rotation speed, the start time and the end time of the operation of the spraying electric pump 226. The control and analysis unit 223 can accurately control the eye drop spraying operation.

[0040] It should be noted that the eye drop storage unit 227 in this embodiment has a standard volume of 1 ml. The hoses connecting the eye drop nozzle 222 to the spraying electric pump 226 and the spraying electric pump 226 to the eye drop storage unit 227 are medical hoses with a diameter of 1.27 mm. The eye drops are sprayed in one working cycle every 8 minutes, and three working cycles are carried out each time; in each working cycle, the eye drops are sprayed 3 times under the guidance of video and voice, and 0.025 ml is sprayed each time; in order to prevent eye discomfort or the atomization from affecting the display effect, the spraying pressure is preferably set to 3.5 mmHg just to atomize the eye drops.

[0041] Specifically, in this embodiment, the spraying area of the eye drops is evenly sprayed on the eyeball body, which is achieved by changing the position and angle of the eye drop nozzle 222 and the spraying pressure. It is also possible to make the patient's eyeball open wide under the guidance of voice and image, and drop the eye drops into the conjunctival sac at a lower pressure, with a dosage of 0.04 ml each time. In this embodiment, the spraying of the eye drops is more uniform and the mydriatic effect is better.

[0042] The audio-visual guiding unit controls the voice playback unit 225 and the video display unit 228 to play voice and video at a specified time through the control and analysis unit 223. Preferably, two voice playback units 225 and two video display units 228 are symmetrically arranged on the device housing 101, and the two video display units 228 are respectively arranged in alignment with the two eyes; the two voice playback units 225 are connected to the control and analysis unit 223 through audio cables, and the two video display units 228 are connected to the control and analysis unit 223 through video cables.

[0043] It should be noted that in this embodiment, the display screens of the 2 video display units 228 are dual FAST LCD screens, Fresnel lenses, with an interpupillary distance of 63.5 mm ± 4 mm, a monocular resolution of 1600 × 1440, a field of view angle of 100°, and an incident eye brightness of 480 nits, which can cover the observation field of the eyeballs; the 2 voice playback units 225 use noise-canceling headphones, PET film diaphragms, and a frequency response range of 5 - 20000 Hz.

[0044] In this embodiment, according to the need to guide eye movement, the control and analysis unit 223 can control the content displayed by the 2 video display units 228 to be the same video or picture, or can also control the 2 video display units 228 to display two different videos or pictures.

[0045] It should be noted that in this embodiment, the control and analysis unit 223 selects a Qualcomm Snapdragon XR2, with a memory of 6G + 128 / 256G, which can meet the requirements of data analysis, data storage, etc.; the battery 221 uses a Li-Polymer lithium polymer battery with a rated capacity of 3020 mAh and can continuously work for 2.5 h after being fully charged.

[0046] It should be noted that in this embodiment, the control and analysis unit 223 has a WIFI communication function and develops an APP application program based on a mobile phone. The setting of mydriasis data, the data after mydriasis ends, etc. are transmitted to the data platform of medical staff through the WIFI method; since medical staff need to save mydriasis time, the mydriasis data is dynamically transmitted to the platform once every 2 minutes during the mydriasis process and once after the mydriasis ends, and medical staff can dynamically master the mydriasis patients and the mydriasis effect.

[0047] It should be noted that after removing the eye drop nozzle 222, the spraying electric pump 226, and the eye drop storage unit 227 of the eye drop spraying system of the automatic mydriasis device, it can be used alone as an automatic mydriasis effect detection device.

[0048] See Figure 2 , this application also discloses a mydriasis method, which uses the automatic mydriasis device and includes the following steps:

[0049] Step 1: Before mydriasis, medical staff assemble the eye drops and set the spraying time, each spraying dose, each closing-eye time after spraying, and the voice and images for guiding eye movement through a wired / wireless data interface.

[0050] In this embodiment, the parameters set by medical staff may include: patient identity information, type of eye drops, start time of each spraying, each spraying dose, spraying interval time, end time, and video for guiding eye movement.

[0051] It should be noted that in this embodiment, Android system and Apple system application programs (APPs) are developed, which can register, set participation, give alarm prompts, and perform result statistics on the device through wifi connection. In order to enable the device to dock with the medical staff data platform, a data interface, a database, and a foreground monitoring subroutine are developed. After the device is connected to the medical staff data platform through wifi, it can upload / download data, and the patient's identity information, medical history, etc. are automatically imported for registration, setting participation, alarm prompting, and result statistics.

[0052] Step 2: The patient wears the mydriasis device, and the image acquisition unit 224 takes pictures of the eye shape and identifies the pupil size. The images and their analysis data are stored in the control and analysis module.

[0053] In this embodiment, the video of eye movement is continuously taken in a specified scenario. When analyzing the images, 5 typical pictures are extracted from 20 pictures per second for pupil diameter analysis. Before mydriasis, the video guides the patient to be emotionally stable and look straight ahead, and the average pupil diameter is found from multiple pictures as the pupil diameter D0 before mydriasis; before strong light irradiates the eye after mydriasis, the video guides the patient to open the eyes wide, and the maximum pupil diameter is found from multiple pictures as the pupil diameter D1 before mydriasis; when strong light irradiates the eye after mydriasis, the video guides the patient to open the eyes wide, and the minimum pupil diameter is found from multiple pictures as the pupil diameter D3 before mydriasis; due to differences in age, eye size, etc., the pupil diameter is 2 - 6 mm before mydriasis, about 8 mm for adults after effective mydriasis, and more than 4 for children.

[0054] Step 3: Using the voice and images of the automatic mydriasis device, guide the patient's eye movement, opening, closing, etc. actions, and spray the eye drops according to the set time and dose.

[0055] In this embodiment, the video for guiding eye movement by the image is dynamically changed according to the needs of detection and spraying of eye drops, and the purpose is to guide the eye to move according to the set process. It includes: images that cause the requirement to observe forward and induce the eye to open wide during spraying; images that guide the eye to make left - right, up - down, and rotational movements; the images for guiding eye movement include pictures and videos; the images for guiding eye movement automatically turn off after the eye movement is completed.

[0056] To guide the required movements, the videos or pictures in the embodiments include videos from far to near, circular motion videos, jump videos, beautiful mountain and water scenery, scary pictures, etc., to increase the immersive interaction feeling of patients observing the videos, and to guide eye rotation, from small to large or from large to small, opening eyes wide in panic, following rotation left and right, up and down, closing eyes, etc.

[0057] When the spraying work cycle ends and the patient needs to close their eyes to rest, the image on the display automatically turns off and goes black. The image display unit and the light-shielding device form a dark room, with no light in front of the patient's eyes. Under the guidance of voice, the patient closes their eyes to rest, promoting drug absorption.

[0058] Step 4, after all the times and doses of eye drops spraying are completed, use a camera to take pictures of the eye shape and pupil size to identify the mydriasis effect.

[0059] It should be noted that in this embodiment, the judgment standard for the pupil diameter before and after mydriasis is not the only standard of 8 mm. Considering the relatively small pupil diameter of children and the universality and practicality of device application, the judgment standard for the pupil diameter before and after mydriasis in the present invention is automatically adjusted according to the size of the pupil diameter.

[0060] Step 5, use voice to inform the patient that the mydriasis is over. The patient removes the mydriasis device, and the medical staff transmits data such as the mydriasis patient information and mydriasis effect to the data platform of the medical staff through a wired / wireless data interface.

[0061] See Figure 3 , this application also discloses a method for detecting mydriasis effect. Using the automatic mydriasis device, it includes the following steps:

[0062] Step 1, before mydriasis, the patient wears the mydriasis device, uses voice and image to induce the eyes to open wide, and the camera takes pictures of the eye shape to identify the pupil diameter D0.

[0063] Step 2, after mydriasis, use voice and image to induce the eyes to open wide, and the camera takes pictures of the eye shape to identify the pupil diameter D1.

[0064] Step 3, determine whether the pupil diameter before and after mydriasis is greater than the set value ΔD5, D1 - D0 ≥ ΔD5? If the pupil diameter before and after mydriasis is less than the set value and the set mydriasis effect is not achieved, it is necessary to continue spraying eye drops for mydriasis; if the pupil diameter before and after mydriasis is not less than the set value, it is necessary to detect whether the pupil retracts under strong light irradiation.

[0065] It should be noted that, unlike the traditional way of judging the effect of mydriasis by medical staff, the traditional method is based on the pupil diameter of about 8mm after mydriasis and the pupil not shrinking under strong light. However, due to the age and eyeball size that vary from person to person, the pupil diameter before mydriasis is 2-6mm, and the pupil diameter of children after mydriasis may also be less than 8mm. In this embodiment, the change in pupil diameter before and after mydriasis ΔD5 is used as the main judgment basis. The value of ΔD5 is based on experience and is pre-set according to the size of the eyeball diameter. This can more accurately determine whether mydriasis is successful and prevent damage to the eye caused by excessive mydriasis anesthesia.

[0066] Step 4, the image display unit emits light at a specified brightness, and the camera captures the shape of the eyeball to identify the pupil diameter D3;

[0067] Step 5, determine whether the pupil diameter changes after strong light irradiation, and whether the change value is less than the set value ΔD6? |D2-D3|≥ΔD6; if the pupil diameter change value after strong light irradiation is not greater than the set value, the pupil diameter meets the mydriasis requirement and the pupil does not shrink after light irradiation, and the mydriasis is successful; if the pupil diameter change value after strong light irradiation is less than the set value, the set mydriasis effect is not achieved.

[0068] It should be noted that, unlike the traditional way of judging the effect of mydriasis by medical staff, which traditionally uses a flashlight to pry open the eyelids to observe whether the pupil shrinks under strong light, the present embodiment uses the light point of the display instead of the flashlight, and uses a camera to obtain an image of the eye to analyze the pupil diameter, and calculates the change in pupil size under strong light and non-strong light to quantitatively analyze the pupil shrinkage under strong light.

[0069] It should be noted that the traditional evaluation and judgment method of mydriasis effect is to achieve mydriasis effect or not; in addition to providing the above evaluation method, the present invention uses a computer to quantify the mydriasis effect: α = ((D1-D0) ÷ ΔD5 × k1 + | D2-D3 | ÷ ΔD6 × k2) × 100%. In the formula, α is the percentage of the mydriasis effect evaluation index; D0 is the pupil diameter before mydriasis, which is the actual measured value through picture analysis; D1 is the pupil diameter after mydriasis, which is the actual measured value through picture analysis; D3 is the pupil diameter when the pupil is exposed to strong light after mydriasis, which is the actual measured value through picture analysis; ΔD5 is the set value of the change in pupil diameter before and after mydriasis; ΔD6 is the set value of the change in pupil diameter under strong light after mydriasis; k1 and k2 are correction values, the main purpose of which is to adjust the weights of the two judgment dimensions, which are set in advance based on the experience of medical staff.

[0070] It should be noted that the value of ΔD5 is determined according to the pupil diameter before pupil dilation and is not a unique value. In this embodiment, two methods are used for setting: one is obtained through a calculation formula, and the calculation method is ΔD5 = D0 × k3, where k3 = 0.5; the other is obtained by looking up a table. For example, when D0 ≤ 2, ΔD5 = 0.5; when 2 < D0 ≤ 3, ΔD5 = 1; ……; when 6 < D0 ≤ 3, ΔD5 = 3.

[0071] It should be noted that the value of ΔD6 is determined according to the pupil diameter before pupil dilation and is not a unique value. In this embodiment, two methods are used for setting: one is obtained through a calculation formula, and the calculation method is ΔD6 = D0 × k4, where k4 = 0.2; the other is obtained by looking up a table. For example, when D0 ≤ 2, ΔD6 = 0.2; when 2 < D0 ≤ 3, ΔD6 = 0.4; ……; when 6 < D0 ≤ 3, ΔD6 = 1.2.

[0072] The above description of the disclosed embodiments enables those skilled in the art to implement or use the present invention. Various modifications to these embodiments will be obvious to those skilled in the art, and the general principles defined herein can be implemented in other embodiments without departing from the spirit or scope of the present invention. Therefore, the present invention will not be limited to the embodiments shown herein, but rather to the widest scope consistent with the principles and novel features disclosed herein.

Claims

1. An automatic mydriasis device, characterized in that, It includes a head-mounted structure, an eye drop spraying system, an audio-visual guiding unit, and an image analysis system mounted on the head-mounted structure; the head-mounted structure covers the eyes to form a dark room, and the audio-visual guiding unit guides the eyes to open wide, rotate or close; the eye drop spraying system sprays eye drops on the eyeball according to the set time and dose; the image analysis system takes images of the shape and movement of the eyeball, and controls the operation of the audio-visual guiding unit and the eye drop spraying system according to the system settings, performs the action of spraying eye drops, and judges the pupil dilation effect through image recognition under the guidance of sound and image by the audio-visual guiding unit.

2. The automatic mydriasis device according to claim 1, characterized in that, The audio-visual guiding unit includes an image display unit, and the image display unit displays picture and video information according to the preset scene according to the time of spraying eye drops, and guides the patient's eyes to close, rotate and open wide following the scene.

3. The automatic mydriasis device according to claim 1, characterized in that, The audio-visual guiding unit includes a voice playback unit, which plays the pre-stored voice according to the instruction of the automatic control module to guide the patient's eyes to perform actions such as closing, rotating and opening wide.

4. The automatic mydriasis device according to claim 1, characterized in that, The eye drop spraying system is composed of an eye drop nozzle, a spraying electric pump, an eye drop storage unit and a control and analysis unit. The eye drop nozzle and the spraying electric pump, and the spraying electric pump and the eye drop storage unit are respectively connected by hoses; the spraying electric pump and the control and analysis unit are electrically connected by wires, and the control and analysis unit controls the rotation speed, start time and end time of the spraying electric pump.

5. The automatic mydriasis device according to claim 4, characterized in that, The image analysis system takes an eyeball video within a specified time through a camera, extracts typical pictures from the continuous video, and analyzes the pupil diameter.

6. The automatic mydriasis device according to claim 4, characterized in that, The control and analysis unit includes a signal input unit, a data storage unit, a calculation and analysis unit, and an output unit. It recognizes the shape and movement of the eyeball according to the image of the camera, drives the image display unit and the sound device to guide the movement of the eyeball, controls the eye drop spraying module to spray eye drops, and judges the pupil dilation effect by image recognition.

7. The automatic mydriasis device according to claim 1, characterized in that, The head-mounted structure is composed of a device shell, a dark room flexible material, a telescopic fastening belt, and a fastening belt telescopic adjustment mechanism. The dark room flexible material and the telescopic fastening belt are integrally installed on the device shell, and the fastening belt telescopic adjustment mechanism is integrally arranged on the telescopic fastening belt; the device shell covers around the eyes through the dark room flexible material, and the telescopic fastening belt is fixed around the head.

8. An automatic mydriasis method, characterized in that, Using the automatic mydriasis device according to any one of claims 1-7, comprising the following steps: (1) Before mydriasis, the medical staff assembles the eye drops, and sets the spraying time, the dosage per spraying, the closing time per spraying, the voice and image for guiding the movement of the eyeball through a wired / wireless data interface; (2) The patient wears the mydriasis device, uses the image acquisition unit to take pictures of the shape of the eyeball, recognizes the pupil size, and stores the image and its analysis data in the control and analysis module; (3) Using the voice and image of the automatic mydriasis device, guiding the patient's eyeball movement, opening wide, closing and other actions, and spraying eye drops according to the set time and dosage; (4) After all the spraying times and dosages of the eye drops are completed, use the camera to take pictures of the shape of the eyeball and the pupil size, and recognize the mydriasis effect; (5) Inform the patient by voice that the mydriasis is over. The patient removes the mydriasis device, and the medical staff transmits data such as the mydriasis patient information and the mydriasis effect to the data platform of the medical staff through a wired / wireless data interface.

9. A method for detecting the mydriatic effect, characterized in that, Using the automatic mydriasis device according to any one of claims 1-7, comprising the following steps: (1) Before mydriasis, the patient wears the mydriasis device, uses voice and images to induce the eyeballs to open wide, the camera takes pictures of the shape of the eyeballs, and identifies the pupil diameter D0; (2) After mydriasis, use voice and images to induce the eyeballs to open wide, the camera takes pictures of the shape of the eyeballs, and identifies the pupil diameter D1; (3) Judge whether the pupil diameter before and after mydriasis is greater than the set value ΔD5, D1 - D0 ≥ ΔD5? If the pupil diameter before and after mydriasis is less than the set value and the set mydriasis effect is not achieved, it is necessary to continue spraying eye drops for mydriasis; if the pupil diameter before and after mydriasis is not less than the set value, it is necessary to detect whether the pupil retracts under strong light irradiation; (4) The image display unit emits light at a specified brightness, the camera takes pictures of the shape of the eyeballs, and identifies the pupil diameter D3; (5) Judge whether the pupil diameter changes after strong light irradiation, and the change value is less than the set value ΔD6? |D2 - D3| ≥ ΔD6; if the change value of the pupil diameter after strong light irradiation is not greater than the set value, the pupil diameter meets the mydriasis requirement and the pupil does not retract after light irradiation, and the mydriasis is successful; if the change value of the pupil diameter after strong light irradiation is less than the set value, the set mydriasis effect is not achieved.

10. The mydriasis effect detection method according to claim 9, characterized in that, The evaluation of the mydriasis effect adopts one of the following two methods: (1) The yes / no judgment method: achieving the mydriasis effect, not achieving the mydriasis effect; (2) The quantitative scoring method: α = ((D1 - D0) ÷ ΔD5 × k1 + |D2 - D3| ÷ ΔD6 × k2) × 100%; where α is the percentage of the mydriasis effect evaluation index; D0 is the pupil diameter before mydriasis; D1 is the pupil diameter after mydriasis; D3 is the pupil diameter during strong light irradiation after mydriasis; ΔD5 is the set value of the change in pupil diameter before and after mydriasis; ΔD6 is the set value of the change in pupil diameter under strong light irradiation after mydriasis; k1, k2 are correction values.

Images