Self-service throat swab nucleic acid sampling device and autonomous nucleic acid sampling method

Abstract

The present invention belongs to the field of medical equipment technology, specifically a self-service throat swab nucleic acid sampling device, which includes a mouth opener and a handheld tool. The sampler places the mouth opener in the mouth to play a guiding and limiting role. The throat swab at the front end of the handheld tool passes through the guide hole on the mouth opener and is inserted into the posterior wall of the pharynx, and rotates under the action of the rotating mechanism to scrape the posterior wall of the pharynx to complete the sampling action. After the sampling is completed, the end cover seals and isolates the specimen. The camera at the front end of the handheld tool records the entire sampling process and wirelessly uploads it to a cloud server or computer host, and the sampling process is reviewed and confirmed by background personnel or AI intelligence. The present invention has a simple structure and is easy to operate. The general population can complete it by themselves, and can effectively divert samplers, improve detection efficiency, avoid the risk of cross infection in doctor-patient contact, and greatly reduce the workload of medical staff. The present invention also discloses a method for self-service nucleic acid sampling using the above-mentioned sampling device.

Description

Technical Field

[0001] The present invention belongs to the technical field of medical equipment, and in particular relates to a self-service throat swab nucleic acid sampling device, and a method for performing self-service nucleic acid sampling using the device. Background Art

[0002] With the spread of COVID-19, more and more people around the world are infected with the virus. Nucleic acid testing is the only standard to determine whether a person is infected with COVID-19. Given the increasing number of asymptomatic infections, universal nucleic acid testing is imperative.

[0003] Throat swab nucleic acid test is currently the main way to diagnose novel coronavirus infection. This operation requires the nurse to use a long test stick to collect samples from the patient's posterior pharyngeal wall. During the sample collection process, due to stimulation of the sampler (defined as the sampled person), it is easy to cause the sampler to cough and sneeze, causing droplets to form aerosols, and aerosols are one of the important transmission routes of novel coronavirus infection; in addition, some samplers may vomit due to throat irritation. The latest research shows (new coronavirus detected in stool), and vomitus may also be a potential source of infection.

[0004] Therefore, people go to the hospital to receive professional medical sampling and have throat swab nucleic acid tests performed by nurses. This not only causes the gathering of people and leads to the risk of disease spread, but also increases the risk of staff being infected. At the same time, due to the large number of people taking samples, a large number of medical personnel are required, which increases the personnel pressure on the hospital and the economic pressure on the country.

[0005] To prevent infection among medical staff, the current protective measures for medical staff are wearing protective devices such as masks, protective clothing, goggles or eye masks, or using the protective device disclosed in the authorization announcement number CN210472180 U, entitled "A protective device for throat swab collection": a transparent barrier is erected between the sampling staff and the sampler, and the sampling staff passes both hands through the two bellows set on the transparent barrier to perform sampling operations on the sampler without affecting the line of sight and operation.

[0006] The above or similar devices can ensure the safety of sampling staff to a certain extent and reduce cross-infection between doctors and patients, but they still cannot achieve complete isolation between doctors and patients, and the hospital still needs to invest a lot of manpower and material resources to carry out high-risk work on the front line, which not only increases the economic pressure on the hospital personnel and the country, but also adds tremendous mental pressure to the vast number of medical workers. Summary of the invention

[0007] In view of the problem that the current throat swab nucleic acid sampling needs to be manually performed by sampling medical personnel, which poses a high risk, the present invention provides a self-service throat swab nucleic acid sampling device, in which the sampling action is completed by the sampler himself, thereby reducing cross infection between doctors and patients.

[0008] To achieve the above object, the technical solution adopted by the present invention is: a self-service throat swab nucleic acid sampling device, including a mouth opener and a handheld tool.

[0009] The mouth opener is a flat cylindrical body, one end of the inner cavity of which is provided with a baffle, the baffle divides the inner cavity of the mouth opener into an intraoral part and an extraoral part, and at least one throat swab guide hole is opened on the baffle;

[0010] The handheld tool comprises a handheld body and an end cover at the top of the body, wherein the handheld body is a flat cylindrical body with a hollow structure and at least one opening is provided at the top, the top of the pharyngeal swab fixing seat is placed in the opening at the top of the handheld body, the lower part of the pharyngeal swab fixing seat is connected to the rotating mechanism, the rotating mechanism is electrically connected to the PCB and the battery, and the bottom cover seals the pharyngeal swab fixing seat, the rotating mechanism, the PCB and the battery in the hollow body of the handheld body;

[0011] The tail end of the pharyngeal swab is inserted into the pharyngeal swab fixing seat, and its front end passes through the pharyngeal swab guide hole on the mouth opener and extends into the oral cavity to contact the posterior wall of the pharynx, and rotates under the action of the pharyngeal swab fixing seat and the rotating mechanism to scrape the posterior wall of the pharynx to complete the sampling action. After the sampling is completed, the end cover is fixed to the top of the handheld body to seal and isolate the pharyngeal swab after the sampling is completed.

[0012] The technical solution for achieving the purpose of the present invention further includes that the throat swab fixing seat includes a rotating tube and an elastic clamp, the rotating tube is in the shape of a circular ring, and its bottom is fixedly connected to the rotating mechanism, the outer diameter of the elastic clamp is smaller than the inner diameter of the rotating tube ring body, its bottom is inserted in the rotating tube, and the top is placed in the opening at the top of the handheld body, and the tail end of the throat swab is inserted in the opening at the top of the elastic clamp.

[0013] The technical solution for achieving the purpose of the present invention further includes that the rotating mechanism includes a motor electrically connected to the PCB and the battery, a driving wheel and a driven wheel,

[0014] The driving wheel is fixedly sleeved on the shaft of the motor, the driven wheel is meshed with the driving wheel, and the rotating tube is fixedly sleeved in the driven wheel.

[0015] A further technical solution of the present invention also includes that a switch column protruding toward the outside of the oral cavity is provided on the baffle of the mouth opener, and a push switch is correspondingly provided on the top of the handheld body, and the push switch is electrically connected to the PCB and the battery. When the pharyngeal swab on the top of the handheld body passes through the pharyngeal swab guide hole on the mouth opener and extends into the oral cavity, the switch column triggers the push switch to rotate the motor, and through the transmission of the rotating mechanism and the pharyngeal swab fixing seat, the pharyngeal swab rotates to scrape the posterior wall of the pharynx to complete the sampling action.

[0016] Furthermore, a camera guide hole is provided on the baffle of the mouth opener, and a camera is correspondingly provided on the top of the handheld body. The camera is electrically connected to the PCB and the battery to shoot the process of throat swab sampling and upload the video to the cloud server or computer host through the WI FI or GSM module on the PCB.

[0017] Further technical contents of the present invention also include a method for self-service nucleic acid sampling using the above-mentioned self-service throat swab nucleic acid sampling device, and the method includes the following process:

[0018] a. The person to be sampled puts the mouthpiece into his mouth;

[0019] b. Remove the end cap from the handheld body and insert the pharyngeal swab into the opening of the elastic clamp at the top of the handheld body;

[0020] c. Hold the handheld body and insert the pharyngeal swab into the posterior pharyngeal wall through the pharyngeal swab guide hole on the mouth opener. When the handheld body touches the mouth opener, the switch column on the mouth opener triggers the key switch of the handheld body. The PCB outputs a pulse current to the motor for a certain period of time. The motor rotates to make the pharyngeal swab rotate synchronously to scrape the posterior pharyngeal wall. The motor stops automatically after rotating for a predetermined time, and the self-service sampling is completed.

[0021] d. Pull out the handheld body and fix the end cap on the top of the handheld body. Seal and isolate the throat swab after sampling and store it at the designated recycling location.

[0022] The beneficial effects of the present invention include:

[0023] 1. The present invention utilizes the design of the mouth opener and the guide hole to guide and position the throat swab when it is inserted, guides the throat swab to accurately reach the sampling site, reduces the difficulty of sampling operation, and enables ordinary people to operate by themselves;

[0024] 2. The camera provided on the handheld body of the present invention can take pictures of the entire sampling process and upload it wirelessly to a cloud server or a computer host. The sampling process is reviewed and confirmed by backstage personnel or AI artificial intelligence, thus avoiding the risk of cross infection caused by direct contact between doctors and patients and greatly reducing the workload of medical staff;

[0025] 3. The present invention uses a rotating mechanism to drive the throat swab to rotate on the inner wall of the oral cavity for sampling, completing the scraping action during manual sampling, making the sampled specimen more real and effective, and improving the success rate of self-service operation for ordinary people;

[0026] 4. The present invention provides a spring between the bottom of the elastic chuck and the bottom of the inner wall of the rotating tube cavity. When the pharyngeal swab is inserted and reaches the posterior pharyngeal wall, the pharyngeal swab can be retracted under the action of the spring force, and will not cause damage to the user's pharynx;

[0027] 5. The switch columns and button switches corresponding to the mouth opener and the handheld body can automatically activate the electrical components such as the rotating mechanism, camera, wireless module, etc. in the handheld body, and automatically stop working to complete sampling according to the pulse current time output by the PCB. This ensures that the sampling position, sampling force, and sampling rotation action are synchronized and accurate, avoiding errors caused by manual operation. BRIEF DESCRIPTION OF THE DRAWINGS

[0028] Figure 1 This is a three-dimensional structural diagram of the mouth opener of the present invention;

[0029] Figure 2 This is a side structural diagram of the mouth opener of the present invention;

[0030] Figure 3 This is a front view structural diagram of the mouth opener of the present invention;

[0031] Figure 4 This is a three-dimensional structural diagram of the handheld tool of the present invention;

[0032] Figure 5 This is a cross-sectional structural diagram of the handheld tool of the present invention;

[0033] Figure 6 This is a structural diagram of the handheld body of the present invention;

[0034] Figure 7 This is a structural diagram of the connection between the handheld body and the throat swab of the present invention;

[0035] Figure 8 for Figure 7 Cross-sectional structural diagram. DETAILED DESCRIPTION

[0036] In order to make the purpose, technical solution and advantages of the embodiments of the present invention clearer, the technical solution in the embodiments of the present invention will be clearly and completely described below in conjunction with the drawings in the embodiments of the present invention. Obviously, the described embodiments are 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.

[0037] The self-service throat swab nucleic acid sampling device described in the present invention comprises a mouth opener 1 and a handheld tool 2. The mouth opener 1 is disposable and is placed in the mouth of a person to be sampled. The person to be sampled operates the handheld tool for self-sampling.

[0038] like Figures 1 to 3 As shown, the mouth opener 1 is a flat cylindrical body, and a baffle 16 is provided at one end of its inner cavity. The baffle 16 divides the inner cavity of the mouth opener 1 into an oral part and an extra-oral part. At least one throat swab guide hole 14 is provided on the baffle 16. This structural design can not only avoid a large area of ​​the oral cavity of the person to be sampled from being exposed to the outside, increasing the risk of infection, but also use the structure of the guide hole for guidance and positioning, avoid the throat swab from being inserted too deeply into the oral cavity and damaging the inner wall of the oral cavity, and can guide the throat swab to accurately reach the sampling site, reducing the difficulty of sampling operation. The embodiment adopted by the present invention is to open throat swab guide holes 14 on the left and right sides respectively, and synchronously sample two specimens for separate testing to improve the efficiency and accuracy of the test.

[0039] A tongue depressor 10 is provided at the lower part of the cylindrical body of the oral part of the mouth opener 1. When the mouth opener 1 is inserted into the mouth of the person to be sampled, the tongue depressor 10 is located on the upper part of the tongue to prevent sampling errors caused by the tongue of the person to be sampled being tilted up.

[0040] The outer wall of the mouth opener 1 is provided with a lip guard 11, and the lip guard 11 divides the outer wall of the mouth opener 1 into an intraoral part and an extraoral part, and the outer wall of the extraoral part of the mouth opener 1 is an outward-expanding trumpet-shaped opening, so that the handheld body 2 can be inserted more accurately, and ensure that the depth of the pharyngeal swab inserted into the oral cavity is accurate, and also ensure that the user will not injure the pharynx during operation.

[0041] The outer wall of the oral cavity portion of the mouth opener 1 is provided with an engaging tooth 12 , which is arc-shaped and matches the shape of the teeth, so that the engaging position is more accurate, thereby achieving the purpose of limiting the mouth opener 1 .

[0042] like Figure 4-Figure 8 As shown, the handheld tool 2 includes a handheld body 221 and an end cover 220 on the top of the body. The handheld body 221 is a flat cylindrical body with a hollow structure and at least one opening on the top. The top of the pharyngeal swab fixing seat is placed in the opening on the top of the handheld body 221. The lower part of the pharyngeal swab fixing seat is connected to the rotating mechanism, and the rotating mechanism is electrically connected to the PCB and the battery 21. The bottom cover 222 seals the pharyngeal swab fixing seat, the rotating mechanism, the PCB and the battery 21 in the hollow body of the handheld body 221.

[0043] The tail end of the throat swab 3 is inserted into the throat swab fixing seat, and its front end passes through the throat swab guide hole 14 on the mouth opener and extends into the oral cavity to contact the posterior wall of the pharynx, and rotates under the action of the throat swab fixing seat and the rotating mechanism to scrape the posterior wall of the pharynx to complete the sampling action. After the sampling is completed, the end cover 220 is fixed to the top of the handheld body 221 to seal and isolate the throat swab 3 after the sampling is completed.

[0044] The pharyngeal swab fixing seat includes a rotating tube 27 and an elastic chuck 28. The rotating tube 27 is in the shape of a ring, and its bottom is fixedly connected to the rotating mechanism. The outer diameter of the elastic chuck 28 is smaller than the inner diameter of the ring of the rotating tube 27. Its bottom is inserted into the rotating tube 27, and the top is placed in the opening at the top of the handheld body 221. The tail end of the pharyngeal swab 3 is inserted into the opening at the top of the elastic chuck 28. A spring 26 is provided between the bottom of the elastic chuck 28 and the bottom of the inner wall of the cavity of the rotating tube 27. When the pharyngeal swab is inserted and reaches the posterior wall of the pharynx, the pharyngeal swab can be retracted under the action of the spring force, and will not cause damage to the user's pharynx.

[0045] The rotating mechanism includes a motor electrically connected to the PCB and the battery, a driving wheel and a driven wheel.

[0046] The driving wheel 23 is sleeved and fixed on the shaft of the motor 22 , the driven wheel 24 is meshed with the driving wheel 23 , and the rotating tube 27 is sleeved and fixed inside the driven wheel 24 .

[0047] The baffle 16 of the mouth opener 1 is provided with a switch column 15 protruding toward the outside of the oral cavity, and a key switch 25 is correspondingly provided on the top of the handheld body 221, and the key switch 25 is electrically connected to the PCB and the battery 21. When the pharyngeal swab 3 on the top of the handheld body 221 passes through the pharyngeal swab guide hole 14 on the mouth opener and extends into the oral cavity, the switch column 15 triggers the key switch 25 to rotate the motor 22. When the motor 22 rotates, the driving wheel 23 fixed on its motor shaft rotates synchronously, and the first driven wheel 24A and the second driven wheel 24B meshed with the driving wheel 23 rotate synchronously, so that the first rotating tube 27A and the second rotating tube 27B rotate together, and the two pharyngeal swabs 3A and 3B respectively fixed on the first elastic chuck 28A and the second elastic chuck 28B rotate on the posterior wall of the pharynx for sampling, completing the scraping action during manual sampling, so that the sampled specimen is more real and effective. The pulse current output by the PCB to the motor causes the motor to automatically stop after a predetermined time, and the self-service sampling is completed, avoiding the pollution caused by manual operation, and being more energy-saving and environmentally friendly.

[0048] A camera guide hole 13 is provided on the baffle 16 of the mouth opener 1, and a camera 29 is correspondingly provided on the top of the handheld body 221. The camera 29 is electrically connected to the PCB and the battery 21. The process of throat swab sampling is filmed and uploaded to the cloud server or computer host. The sampling process is reviewed and confirmed by backstage personnel or AI artificial intelligence, avoiding the risk of cross-infection caused by direct contact between doctors and patients and greatly reducing the workload of medical staff.

[0049] The end cap 220 is fixed to the top of the handheld body 221 by snapping or threading, and its height is greater than the height of the throat swab 3. It should be ensured that the top and side of its inner wall do not contact the sampling device on the top of the throat swab 3, and the specimen is sealed and isolated from the external environment to prevent the specimen from being contaminated and causing misdiagnosis.

[0050] Further technical contents of the present invention also include a method for self-service nucleic acid sampling using the above-mentioned self-service throat swab nucleic acid sampling device, and the method includes the following process:

[0051] a. The person to be sampled puts the mouthpiece into his mouth;

[0052] b. Remove the end cap from the handheld body and insert the pharyngeal swab into the opening of the elastic clamp at the top of the handheld body;

[0053] c. Hold the handheld body and insert the pharyngeal swab into the posterior pharyngeal wall through the pharyngeal swab guide hole on the mouth opener. When the handheld body touches the mouth opener, the switch column on the mouth opener triggers the key switch of the handheld body. The PCB outputs a pulse current to the motor for a certain period of time. The motor rotates to make the pharyngeal swab rotate synchronously to scrape the posterior pharyngeal wall. The motor stops automatically after rotating for a predetermined time, and the self-service sampling is completed.

[0054] d. Pull out the handheld body and fix the end cap on the top of the handheld body. Seal and isolate the throat swab after sampling and store it at the designated recycling location.

[0055] The above step c also includes the switch column triggering the button switch of the handheld body, the PCB starting the camera, the camera shooting the process of throat swab sampling through the camera guide hole set on the baffle of the mouth opener, and uploading the video to the cloud server or computer host through the WI FI or GSM module on the PCB, and the sampling process is reviewed and confirmed by the background personnel or AI artificial intelligence.

[0056] The self-service throat swab nucleic acid sampling device of the present invention can be used in conjunction with a self-service vending machine and placed in places such as airports, stations, ports, shopping malls, schools, hospitals, etc. After the sampler reads the ID card, enters the phone number and other information to confirm the real name and scans the code to pay, the sampler can obtain a sampling device with a unique identification code (such as a barcode, a QR code) from the pickup port of the vending machine. The identification code corresponds to the identity information of the sampler, and the vending machine stores the above information. After the sampling is completed, the sampler deposits the sampled specimen into the vending machine through the recovery port of the vending machine. The vending machine archives and records the information, and refrigerates and stores it inside the machine, waiting for the staff to centrally recover and test the sampled specimens. The above mode can effectively divert the samplers, so that they can complete the sampling nearby without gathering in the hospital, effectively improving the detection efficiency, avoiding cross infection caused by the gathering of people, and reducing the work pressure of the hospital medical staff, with good economic and social benefits.

Claims

1. A self-service throat swab nucleic acid sampling device, comprising a mouth opener and a handheld tool, characterized in that: The mouth opener (1) is a flat cylindrical body, and a baffle (16) is provided at one end of its inner cavity, and the baffle (16) divides the inner cavity of the mouth opener (1) into an intraoral part and an extraoral part, and at least one throat swab guide hole (14) is provided on the baffle (16); The handheld tool (2) comprises a handheld body (221) and an end cover (220) at the top of the body, wherein the handheld body (221) is a flat cylindrical body having a hollow structure and having at least one opening at the top, wherein the top of the pharyngeal swab fixing seat is placed in the opening at the top of the handheld body (221), the bottom of the pharyngeal swab fixing seat is connected to a rotating mechanism, the rotating mechanism is electrically connected to a PCB and a battery (21), and the bottom cover (222) seals the pharyngeal swab fixing seat, the rotating mechanism, the PCB and the battery (21) in the hollow body of the handheld body (221); The tail end of the pharyngeal swab (3) is inserted into the pharyngeal swab fixing seat, and the front end thereof passes through the pharyngeal swab guide hole (14) on the mouth opener and extends into the oral cavity to contact the posterior pharyngeal wall, and rotates under the action of the pharyngeal swab fixing seat and the rotating mechanism to scrape the posterior pharyngeal wall to complete the sampling action. After the sampling is completed, the end cover (220) is fixed to the top of the handheld body (221) to seal and isolate the pharyngeal swab (3) after the sampling is completed.

2. The self-service throat swab nucleic acid sampling device according to claim 1, characterized in that: A tongue depressor (10) is provided at the lower part of the cylindrical body of the oral cavity portion of the mouth opener (1).

3. The self-service throat swab nucleic acid sampling device according to any one of claims 1 or 2, characterized in that: The outer wall of the mouth opener (1) is provided with a lip retaining edge (11), and the lip retaining edge (11) divides the outer wall of the mouth opener (1) into an intra-oral part and an extra-oral part.

4. The self-service throat swab nucleic acid sampling device according to claim 3, characterized in that: The outer wall of the outer part of the mouth opener (1) outside the oral cavity is an outward-expanding trumpet-shaped opening.

5. The self-service throat swab nucleic acid sampling device according to claim 1, characterized in that: The pharyngeal swab fixing seat comprises a rotating tube (27) and an elastic clamp (28); the rotating tube (27) is in the shape of a circular ring, and its bottom is fixedly connected to the rotating mechanism; the outer diameter of the elastic clamp (28) is smaller than the inner diameter of the rotating tube (27); its bottom is inserted into the rotating tube (27), and its top is placed in the opening at the top of the handheld body (221); the tail end of the pharyngeal swab (3) is inserted into the opening at the top of the elastic clamp (28).

6. The self-service throat swab nucleic acid sampling device according to claim 5, characterized in that: A spring (26) is provided between the bottom of the elastic clamp (28) and the bottom of the inner wall of the cavity of the rotating tube (27).

7. The self-service throat swab nucleic acid sampling device according to any one of claims 1 or 5, characterized in that: The rotating mechanism includes a motor electrically connected to the PCB and the battery, a driving wheel and a driven wheel. The driving wheel (23) is sleeved and fixed on the shaft of the motor (22), the driven wheel (24) is meshed with the driving wheel (23), and the rotating tube (27) is sleeved and fixed in the driven wheel (24).

8. The self-service throat swab nucleic acid sampling device according to claim 1, characterized in that: A switch column (15) protruding toward the outside of the oral cavity is provided on the baffle plate (16) of the mouth opener (1), and a push switch (25) is correspondingly provided on the top of the handheld body (221). The push switch (25) is electrically connected to the PCB and the battery (21). When the pharyngeal swab (3) on the top of the handheld body (221) passes through the pharyngeal swab guide hole (14) on the mouth opener and extends into the oral cavity, the switch column (15) triggers the push switch (25) to rotate the motor (22). Through the transmission of the rotating mechanism and the pharyngeal swab fixing seat, the pharyngeal swab rotates to scrape the posterior wall of the pharynx to complete the sampling action.

9. The self-service throat swab nucleic acid sampling device according to claim 1, characterized in that: A camera guide hole (13) is provided on the baffle (16) of the mouth opener (1), and a camera (29) is correspondingly provided on the top of the handheld body (221). The camera (29) is electrically connected to the PCB and the battery (21) to shoot the process of throat swab sampling and upload the video to a cloud server or a computer host through the WIFI or GSM module on the PCB.

10. The self-service throat swab nucleic acid sampling device according to claim 1, characterized in that: The end cover (220) is fixed to the top of the handheld body (221) by snapping or screwing.

11. A method for self-service nucleic acid sampling using the self-service throat swab nucleic acid sampling device according to claim 1, characterized in that: The method includes the following steps: a. The person to be sampled puts the mouthpiece into his mouth; b. Remove the end cap from the handheld body and insert the pharyngeal swab into the opening of the elastic clamp at the top of the handheld body; c. Hold the handheld body and insert the pharyngeal swab into the posterior pharyngeal wall through the pharyngeal swab guide hole on the mouth opener. When the handheld body touches the mouth opener, the switch column on the mouth opener triggers the key switch of the handheld body. The PCB outputs a pulse current to the motor for a certain period of time. The motor rotates to make the pharyngeal swab rotate synchronously to scrape the posterior pharyngeal wall. The motor stops automatically after rotating for a predetermined time, and the self-service sampling is completed. d. Pull out the handheld body and fix the end cap on the top of the handheld body. Seal and isolate the throat swab after sampling and store it at the designated recycling location.

12. The self-service nucleic acid sampling method according to claim 11, characterized in that: The step c also includes the switch column triggering the button switch of the handheld body, the PCB starting the camera, the camera shooting the process of throat swab sampling through the camera guide hole set on the baffle of the mouth opener, and uploading the video to the cloud server or computer host through the WIFI or GSM module on the PCB.

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