A jet-type ocular surface microbial aerosol direct capture sampling device and sampling method

Abstract

A jet-type ocular surface microbial aerosol direct capture sampling device and sampling method, including a sampler body worn on both eyes, the sampler body is provided with a strap for fixing the sampler body on the head, the middle of the sampler body is a sampling cavity, the sampling cavity is provided with a bracket for placing a sampling dish, the top of the sampler body is provided with a socket, the sampling dish is inserted into the sampler body through the socket and fixed on the bracket, the sampling device also includes a jet device for generating pulse gas to impact the center of the ocular surface tear film to generate aerosol particles, the present invention uses the jet device to spray gas to impact the human ocular surface, and the generated microbial aerosol is captured by the sampling dish for microbial detection, the sampling efficiency is high, the contact area with the ocular surface is large, and the ocular microbial situation is fully reflected. The misdiagnosis and missed diagnosis rate is low, the detection method is non-invasive and painless, the detection method is simple and operable, and sampling and detection can be performed anytime and anywhere.

Description

Technical Field

[0001] The invention relates to the technical field of ophthalmic medical instruments, and in particular to a jet-type ocular surface microbial aerosol direct capture sampling device and a sampling method. Background Art

[0002] The existing method for detecting ocular surface tissue microorganisms is to pre-moisten, contact the conjunctival sac and the surface of the tarsal conjunctiva, collect ocular surface secretions, and perform smear microscopy and other tests. This method has a limited contact area and is easily contaminated by eyelid, eyelash and surrounding skin microorganisms, resulting in misdiagnosis; conjunctival sac sampling is an indirect method, and the process of smearing the sample on the blood agar culture dish will reduce the microorganisms, which is easy to cause missed diagnosis. The technical operation is complex and the cost is high, and it is even more difficult to fully collect and reflect the growth of ocular surface microorganisms. Summary of the invention

[0003] In order to solve the technical defects and shortcomings of the prior art, the present invention provides a jet-type ocular surface microbial aerosol direct capture sampling device and a sampling method.

[0004] The technical solution adopted by the present invention is: a jet-type ocular surface microbial aerosol direct capture sampling device, including a sampler body worn on both eyes, the sampler body is provided with a strap for fixing the sampler body on the head, the middle of the sampler body is a sampling cavity, the sampling cavity is provided with a bracket for placing a sampling dish, the top of the sampler body is provided with a socket, the sampling dish is inserted into the sampler body through the socket and fixed on the bracket, and the sampling device also includes a jet device for generating pulse gas to impact the ocular surface tear film to produce aerosol particles.

[0005] The front end of the sampler body is provided with a lid expansion device, which is an inverted funnel-shaped structure made of silicone rubber. The lid expansion device is detachably connected to the sampler body.

[0006] The jet device comprises a small air pump and a jet conduit connected to the small air pump, the jet conduit is arranged along the inverted funnel-shaped inner wall of the eyelid expansion device, and the small air pump is arranged on the outer side of the sampler body.

[0007] The upper and lower sides of the sampler body are both provided with air-jet devices.

[0008] The rear part of the sampler body is also provided with a micro exhaust mechanism, which comprises an exhaust cavity and an exhaust fan, and the exhaust cavity is connected with the sampling cavity through a channel at the bottom of the sampling cavity.

[0009] The exhaust fan is arranged in the exhaust cavity, and the rear end of the exhaust cavity is also provided with an exhaust port.

[0010] There are two sampler bodies, each used to collect microbial aerosols generated by both eyes.

[0011] A jet-type ocular surface microbial aerosol direct capture sampling method comprises the following steps:

[0012] 1) Place the sampling dish for collecting microbial aerosol in the sampling device;

[0013] 2) Use a jet of 15V / sec±0.8V / sec to impact the ocular surface, causing the tear film on the ocular surface to break and vaporize in the air to form aerosol particles carrying ocular surface microorganisms;

[0014] 3) Use the sampling device to set the ideal sampling volume and capture the aerosol particles formed after the tear film tissue on the ocular surface is vaporized at a flow rate of 100L / min;

[0015] 4) Remove the collected culture dish from the sampling device and perform colony culture for subsequent identification.

[0016] The beneficial effects of the present invention are as follows: the present invention provides a jet-type ocular surface microbial aerosol direct capture sampling device and sampling method, including a sampler body worn on both eyes, the sampler body is provided with a strap for fixing the sampler body on the head, the middle of the sampler body is a sampling cavity, the sampling cavity is provided with a bracket for placing a sampling dish, the top of the sampler body is provided with a socket, the sampling dish is inserted into the sampler body through the socket and fixed on the bracket, the sampling device also includes a jet device for generating pulse gas to impact the ocular surface tear film to generate aerosol particles, the present invention uses the jet device to spray gas to impact the human ocular surface, and the generated microbial aerosol is captured by the sampling dish for microbial detection, the sampling efficiency is high, the contact area with the ocular surface is large, and the ocular microbial situation is fully reflected. The misdiagnosis and missed diagnosis rate is low, the detection method is non-invasive and painless, the detection method is simple and operable, and sampling and detection can be performed anytime and anywhere. BRIEF DESCRIPTION OF THE DRAWINGS

[0017] Figure 1 It is a schematic diagram of the structure of the present invention.

[0018] Figure 2 It is a schematic diagram of the structure of the sampler body of the present invention.

[0019] Among them, 1 is the sampler body, 2 is the strap, 3 is the jet device, 4 is the eyelid expansion device, 11 is the sampling cavity, 12 is the bracket, 13 is the sampling dish, 31 is the small air pump, 32 is the jet duct, 41 is the exhaust fan, and 42 is the exhaust port. DETAILED DESCRIPTION

[0020] The following will be combined with the drawings in the embodiments of the present invention to clearly and completely describe the technical solutions in the embodiments of the present invention. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention.

[0021] A jet-type ocular surface microbial aerosol direct capture sampling device includes a sampler body 1 worn on both eyes, and the number of the sampler bodies 1 is two, respectively used to collect microbial aerosols on both eyes. The sampler body 1 is provided with a strap 2 for fixing the sampler body 1 on the head, the middle of the sampler body 1 is a sampling cavity 11, and the sampling cavity 11 is provided with a bracket 12 for placing a sampling dish 13. The top of the sampler body 1 is provided with a socket, and the sampling dish 13 is inserted into the sampler body 1 through the socket and fixed on the bracket 12. The sampling device also includes a jet device 3 for generating pulse gas to impact the tear film of the ocular surface to generate aerosol particles. The present invention uses the jet device to spray gas to impact the human ocular surface, and the microbial aerosol generated is captured by the sampling dish to perform microbial detection. The sampling efficiency is high, the contact area with the ocular surface is large, and the ocular microbial situation is fully reflected. The misdiagnosis and missed diagnosis rate is low, the detection method is non-invasive and painless, the detection method is simple and operable, and sampling and detection can be performed anytime and anywhere.

[0022] The front end of the sampler body 1 is provided with a lid expansion device 4, which is an inverted funnel-shaped structure made of silicone rubber. The lid expansion device 4 is detachably connected to the sampler body 1.

[0023] The jet device 3 includes a small air pump 31 and a jet conduit 32 connected to the small air pump 31. The jet conduit 32 is arranged along the inner wall of the inverted funnel shape of the eyelid expansion device 4. The small air pump 31 is arranged on the outer side of the sampler body 1. The jet device 3 is arranged on both the upper and lower sides of the sampler body 1.

[0024] A micro exhaust mechanism 4 is also provided at the rear of the sampler body 1 . The micro exhaust mechanism 4 includes an exhaust cavity and an exhaust fan 41 . The exhaust cavity is connected to the sampling cavity 11 through a channel at the bottom of the sampling cavity 11 .

[0025] The exhaust fan 41 is disposed in the exhaust cavity, and an exhaust port 42 is also disposed at the rear end of the exhaust cavity.

[0026] The sampling device is provided with a charging port and a power cord for connecting to a power source to replenish and maintain the internal power of the instrument.

[0027] During sampling, the jet device emits a jet of 15V / sec±0.8V / sec to impact the tear film on the human eye surface, generating aerosol particles. The sampling device is turned on, and the sampling flow rate is set to 100L / min. The aerosol particles hit the culture dish inside the sampling port, thereby capturing microbial aerosols. The culture dish is taken out from the culture dish slot and transferred for culture and subsequent colony identification.

[0028] Experimental procedures

[0029] A single-center randomized controlled clinical trial research design was adopted, and 20 subjects (40 eyes) who visited a tertiary-level A ophthalmology hospital in Wenzhou City on December 17, 2021 were selected as research subjects. Inclusion criteria: 1. Able to cooperate with ophthalmic examinations 2. Good cognitive ability. Exclusion criteria: 1. History of infectious diseases and epidemics in epidemic areas Before entering the trial cohort, all subjects understood the methods and objectives of this study and voluntarily signed informed consent. The research protocol adheres to the principles of the Declaration of Helsing and was approved by the Ethics Committee of the Eye and Optometry Hospital Affiliated to Wenzhou Medical University, Wenzhou, China for measurement and data analysis (2020-018-K-16). The sampling personnel in this experiment were all the same person. The experimental subjects were all from the same population, the experiments were conducted at the same time, and the same batch of blood culture dishes were used.

[0030] 1. Preparation before the experiment: Choose a clinic with an area of ​​about 30 square meters. Perform daily cleaning and disinfection before the test. Use a circulating air purifier to purify for 8 hours the night before. During the inspection, no unrelated personnel are allowed to walk around. Experimenters wear masks, goggles, work clothes, and sterile caps.

[0031] A total of 20 subjects were examined, with an age of (41±15.84), 8 males and 12 females. The experimental subjects were all from the same population. The subjects of this experiment were all voluntary, and the same group of subjects were tested for pathogenic microorganisms in both eyes once using the traditional conjunctival sac swab sampling method and the jet ocular surface microbial aerosol direct capture sampling method.

[0032] 2. Experimental Procedure

[0033] 2.1 Traditional conjunctival sac swab sampling method (Group A):

[0034] The specimens were collected by professionals. The swab was pre-moistened with sterile saline before sampling. No anesthetic was used during sampling. Explanations were made before sampling. The subjects took a seat, wore masks and remained silent throughout the process. The patients were asked to look up, turn over the lower eyelid, expose the underlying bulbar conjunctiva and inferior fornix conjunctiva, and use a swab moistened with sterile saline to gently wipe the underlying conjunctival sac and the surface of the lower eyelid conjunctiva from the inside to the outside starting from the inner canthus (be careful not to miss the inner canthus), avoiding contact with eyelashes and eyelid margins. After sampling, the samples were inoculated on blood agar medium.

[0035] 2.2 Jet-type ocular surface microbial aerosol direct capture sampling method (Group B):

[0036] For the same batch of subjects as the conjunctival sac sampling, the air was disinfected with 75% alcohol before sampling each eye, and then the sampling device was used to sample 30L of gas. The blood agar culture medium was placed in the sampling device and placed at the sampling port perpendicular to the airflow direction for air sampling, and a baseline group was set. The intraocular pressure measurement used a jet device to generate airflow. Before the jet sampling, the explanation was done. The subjects sat down, wore masks throughout the process and remained silent, opened their eyes naturally and exposed the cornea, and jetted three times continuously. During the jetting process, 30L of gas was sampled simultaneously.

[0037] 2.3 Culture and identification: The culture medium after sampling is placed at room temperature (12-23°C) for 3-5 days to identify the species of the colonies.

[0038] 2.4 Statistical analysis: SPSS25.0 software was used to perform statistical analysis on the experimental data. The chi-square test was used to measure the differences in the test results. The experimental data are shown in Appendix 1.

[0039] 3 Experimental results

[0040] The traditional conjunctival sac swab sampling (group A) obtained colony culture samples (40 samples), and the jet ocular surface microbial aerosol direct capture sampling method (group B) (80 samples). The jet ocular surface microbial aerosol direct capture sampling method was used to obtain the microbial aerosol colonies on the patient's ocular surface and compared with the air baseline before the test. The positive rate of group B was higher than that obtained by group A (χ 2 =51.678, P<0.001), 74 bacterial species were detected, including 32 potential pathogens, while traditional conjunctival sac swab test could only detect 6 bacterial species such as Staphylococcus and Moraxella osloensis, which are common normal flora in the eye.

[0041] The low efficiency of traditional conjunctival sac swab detection may be related to its limited contact with the eye. Its detection range cannot radiate to the entire ocular surface colony, the reflected range is low, the detection efficiency is low, and it is easy to be contaminated by eyelids, eyelashes and surrounding skin microorganisms, resulting in misdiagnosis; conjunctival sac sampling is an indirect method, and the process of smearing the sample on the blood agar culture dish will reduce the microorganisms, which is easy to cause missed diagnosis. The technical operation is complicated, the cost is high, and it is more difficult to fully collect and reflect the growth of ocular surface microorganisms. The sampling method adopted by this patent can cover the detection range to the entire ocular surface through air jet, expand the detection range, effectively improve the positive rate, and reduce the misdiagnosis rate.

[0042] Technical personnel should note that although the present invention has been described according to the above specific implementation methods, the inventive concept of the present invention is not limited to this invention, and any modification using the inventive concept will be included in the scope of protection of this patent.

[0043] The above is only a preferred embodiment of the present invention, and the protection scope of the present invention is not limited to the above embodiments. All technical solutions under the concept of the present invention belong to the protection scope of the present invention. It should be pointed out that for ordinary technicians in this technical field, some improvements and modifications without departing from the principle of the present invention should also be regarded as the protection scope of the present invention.

[0044] Schedule 1

[0045]

[0046]

[0047]

[0048]

[0049]

[0050]

[0051] Note: 17 indicates the conjunctival sac and microbial aerosol samples extracted on the 17th, P indicates the ocular surface microbial aerosol samples collected using this protocol, and N indicates the colony samples obtained by conjunctival sac swab testing; the first number after that indicates the subject number, the second number after that 01 indicates the air baseline before the right eye test, O2 indicates the air baseline before the left eye test, 1 indicates the right eye, and 2 indicates the left eye; for example: 17-P-1-01 indicates the microbial aerosol sample of the air baseline group before the right eye test of the first patient tested by this method on the 17th.

Claims

1. A jet-type ocular surface microbial aerosol direct capture sampling method, characterized in that: The following steps are involved: 1) Place the sampling dish for collecting microbial aerosols in the jet-type ocular surface microbial aerosol direct capture sampling device; 2) Use a jet of air at a speed of 15 m / sec ± 0.8 m / sec to impact the ocular surface, causing the tear film on the ocular surface to break and vaporize in the air to form aerosol particles carrying ocular surface microorganisms; 3) Use the sampling device to set the ideal sampling volume and capture the aerosol particles formed after the tear film tissue on the ocular surface is vaporized at a flow rate of 100L / min; 4) Remove the collected culture dish from the sampling device and perform colony culture for subsequent identification; The jet-type ocular surface microbial aerosol direct capture sampling device comprises a sampler body (1) worn on both eyes, the sampler body (1) is provided with a strap (2) for fixing the sampler body (1) on the head, the middle of the sampler body (1) is a sampling cavity (11), the sampling cavity (11) is provided with a bracket (12) for placing a sampling dish (13), the top of the sampler body (1) is provided with a socket, the sampling dish (13) is inserted into the sampler body (1) through the socket and fixed on the bracket (12), the sampling device also comprises a jet device (3) for generating pulse gas to impact the ocular surface tear film to generate aerosol particles, the jet device (3) comprises a small air pump (31) and a jet conduit (32) connected to the small air pump (31), the jet conduit (32) is arranged along the inverted funnel-shaped inner wall of the eyelid expansion device (4), the small air pump (31) is arranged on the outside of the sampler body (1), and the jet device (3) is arranged on both the upper and lower sides of the sampler body (1).

2. The method according to claim 1, characterized in that The front end of the sampler body (1) is provided with a lid expansion device (4), the lid expansion device (4) is an inverted funnel-shaped structure made of silicone rubber, and the lid expansion device (4) is detachably connected to the sampler body (1).

3. The method according to claim 1, characterized in that A micro exhaust mechanism is also provided at the rear of the sampler body (1), the micro exhaust mechanism comprising an exhaust chamber and an exhaust fan (41), the exhaust chamber being connected to the sampling chamber (11) through a channel at the bottom of the sampling chamber (11).

4. The method according to claim 3, characterized in that The exhaust fan (41) is arranged in the exhaust cavity, and an exhaust port (42) is also arranged at the rear end of the exhaust cavity.

5. The method according to claim 4, characterized in that The number of the sampler bodies (1) is two, each used to collect microbial aerosols generated by both eyes.

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