Oral mucosal exudate collection device and method

Abstract

This invention provides an oral mucosal exudate collection device and method, relating to the field of oral sampling technology. The device includes an outer shell, with a collection tube fixedly mounted at one end. The collection tube has a collection hole at its end. Inside the collection tube are a rotating connector and a telescopic sleeve. The rotating connector has multiple elastic plates, and the telescopic sleeve covers all the elastic plates. The advantages of this invention are: the operator only needs to insert the collection tube into the oral cavity once, and can sequentially collect exudates from multiple different locations such as the gingiva, sublingual region, and buccal mucosa by switching the collection head within the oral cavity. This significantly simplifies the operation process, reduces the patient's mouth-opening time and discomfort, and is particularly suitable for applications requiring multi-point comparative analysis or large-area screening. During the collection process, the unused collection head remains sealed inside the collection tube, effectively preventing accidental mixing of exudates from different collection sites and ensuring the uniqueness of each sample's origin and the accuracy of the test.

Description

Technical Field

[0001] This invention relates to the field of oral sampling technology, specifically to an oral mucosal exudate collection device and collection method. Background Technology

[0002] Oral mucosal exudate, as a non-invasive biological sample, contains abundant antibodies, hormones, and pathogen markers, and has significant application value in disease diagnosis, drug monitoring, and health screening. Existing oral mucosal exudate collection devices typically use a single collection head, sampling via swab wiping or passive adsorption.

[0003] Chinese patent application CN201910429708.1 discloses a precise saliva microecological specimen collection device, comprising a collection device body and a protective cover. The collection device body includes a screw cap connected to the protective cover and a base located inside the screw cap. Two parallel connecting posts are arranged on the base, and two stainless steel tongues are movably connected to the connecting posts. Each stainless steel tongue includes a top contact end and a bottom control end. The opposing surfaces of the bottom of the control ends of the two stainless steel tongues are connected by a spring. A humidity sensor is respectively installed in the middle of the inner surface of the contact end of each stainless steel tongue. A spunlace nonwoven fabric collection sleeve with a matching shape is fitted over the contact end. A warning light is provided at the bottom of the collection device body. During sampling, the device is directly inserted into the oral cavity to collect saliva, avoiding contamination by microorganisms on the lips. Furthermore, the collection device uses nonwoven fabric to absorb saliva, eliminating the need for the subject to cough up sputum to meet the required saliva collection volume, and the specimen is not contaminated by phlegm from the throat.

[0004] Existing oral exudate collection devices typically cannot collect samples from different locations in the oral cavity in a single sampling. The composition of exudate varies in different areas of the oral cavity (such as the gingival sulcus, sublingual region, and inner cheek), making samples collected from a single location less representative and unable to comprehensively reflect physiological or pathological conditions. If multi-point sampling analysis is required, the operator must use different collection tools to collect samples multiple times, which is cumbersome and time-consuming. Furthermore, when sampling at deeper locations, an oral support structure is required, which necessitates repeated large-angle mouth openings and the installation of the oral support device, significantly increasing patient discomfort. In addition, during sampling, the sampling head of existing collection devices is prone to contact with multiple different areas during oral cavity movement, making the collected samples susceptible to cross-contamination by body fluids or rinsing fluids from other areas, leading to distorted test results. Moreover, for patients with dry mouth or insufficient exudate secretion, the collection head cannot directly absorb sufficient sample, resulting in a low sampling success rate. Summary of the Invention

[0005] To overcome the shortcomings of existing technologies, this collection device allows operators to collect exudate from multiple different locations in the oral cavity by inserting the collection tube into the mouth once. It also effectively prevents accidental mixing of exudate from different collection sites, ensuring the uniqueness of each sample's origin and the accuracy of the test. In addition, before sampling, the device can spray rinsing fluid onto the target area and then aspirate the target area, greatly improving the success rate of collection and avoiding the problem of low success rate of traditional dry swab collection.

[0006] The above-mentioned technical objective of the present invention is achieved through the following technical solution: an oral mucosal exudate collection device, comprising an outer shell, a collection tube fixedly provided at the end of the outer shell, and a collection hole provided at the end of the collection tube;

[0007] The collection tube is equipped with a rotating connector and a telescopic sleeve. The rotating connector is equipped with multiple elastic plates. One end of the elastic plate is fixedly connected to the rotating connector, and the other end is inclined outward. A collection head is fixedly provided at the end of each elastic plate, and one end of the collection head passes through the collection hole and extends out of the collection tube.

[0008] The rotating connector is equipped with a telescopic drive mechanism. The telescopic sleeve is fitted over all the elastic plates. The inner wall of the telescopic sleeve is in sliding contact with the outer wall of the elastic plate. The telescopic shaft of the telescopic drive mechanism is fixedly connected to the telescopic sleeve. The telescopic drive mechanism is used to drive the telescopic sleeve to move along the axial direction of the collection tube, thereby adjusting the distance from the collection head at the end of the elastic plate to the axis of the collection tube.

[0009] A rotation drive mechanism is fixedly installed inside the outer casing. The rotation drive mechanism is connected to the rotation connector and is used to rotate the connector so that different collection heads are exposed from the collection holes.

[0010] An air extraction pipe is connected to the outer casing. The air extraction pipe is used to connect to the air extraction device. Each collection head is connected to a collection hose, which is connected to the air extraction pipe.

[0011] Furthermore, the inner wall of the collection head is provided with a spray chamber; the inner wall of the collection head is provided with multiple spray holes, all of which are connected to the spray chamber; each collection head is also connected to a spray hose that is connected to the spray chamber.

[0012] The collection tube is also equipped with a flushing nozzle, and a spray hose is connected to the end of the flushing nozzle. The flushing nozzle is connected to a spraying device, which includes a storage tank and a flushing pump. The flushing pump is used to transport the flushing liquid in the storage tank to the spray hose and spray it out from the spray hole.

[0013] Furthermore, the flushing nozzle is also equipped with a flow sensor and a spray head at its end. The spray head is equipped with a micro-control valve, which is used to control the on / off state of the spray hose, so that the flushing liquid in the flushing nozzle flows to the spray hose connected to the collection head located in the collection hole.

[0014] The flow sensor is used to record the amount of liquid sprayed from the spray hose each time.

[0015] Furthermore, each of the aforementioned acquisition heads is provided with a flexible gasket ring at its end.

[0016] Furthermore, the outer shell is also provided with multiple collection and storage boxes, which are fixed inside the collection tube. Each collection and storage box contains multiple storage chambers, and each storage chamber is connected to a collection head through a collection hose. The storage chamber is connected to an air extraction pipe.

[0017] Furthermore, the collection and storage box is provided with a first end cover and a second end cover at both ends, the first end cover is provided with a plurality of collection connectors, each collection connector being connected to a storage chamber; the first end cover is fixed to the outer shell by a collection fixing ring, and each collection hose is connected to a collection connector; the second end cover is connected to an air extraction pipe.

[0018] Furthermore, the end of the collection and storage box away from the first end cover is provided with a breathable and water-resistant membrane;

[0019] The outer casing has an openable cover at one end, and the second end cap is fixed to the inner wall of the cover.

[0020] Furthermore, the telescopic drive mechanism is an electric push rod, which is fixed to the inner wall of the rotating connector, and the telescopic shaft of the electric push rod is connected to the telescopic sleeve through a telescopic connecting rod.

[0021] Furthermore, the rotation drive mechanism is a rotation drive motor, which is fixed to the inner wall of the outer casing by a motor fixing ring, and a drive gear is fixedly provided at the end of the rotation output shaft of the rotation drive motor;

[0022] The rotating connector has a driven gear ring at its end, and the driving gear meshes with the driven gear ring.

[0023] The present invention also provides a method for collecting oral mucosal exudate using the above-mentioned oral mucosal exudate collection device, the method comprising the following steps:

[0024] S1: Insert the collection tube into the patient's oral cavity, so that the collection head, which is limited to the collection hole of the collection tube, is pressed against the first collection position on the inner wall of the patient's oral cavity.

[0025] S2: Start the flushing pump. The flushing fluid is sprayed from the spray hole of the collection head, which is located in the collection hole, to flush the first collection position in the patient's oral cavity, so that the exudate in the first collection position in the patient's oral cavity flows into the first collection head through the flushing fluid.

[0026] S3: Start the air extraction device, which will pump the exudate and washing liquid into the corresponding storage chamber for storage.

[0027] S4: Start the telescopic drive mechanism to move the telescopic sleeve away from the rotating connector, thereby causing the acquisition head, which is confined in the acquisition hole, to retract into the acquisition tube.

[0028] S5: The rotary drive mechanism drives the rotary connector to rotate at a certain angle, thereby moving the other acquisition head to the position facing the acquisition hole; the telescopic drive mechanism is activated again, driving the telescopic sleeve to approach the rotary connector, and the end of the elastic plate with the acquisition hole is elastically reset, so that the acquisition head facing the acquisition hole is exposed from the acquisition hole.

[0029] S6: Move the collection tube to a different position and repeat steps S2-S5 multiple times to complete multi-point sampling of oral exudate.

[0030] The beneficial effects of the oral mucosal exudate collection device and collection method of the present invention are as follows:

[0031] (1) The oral mucosal exudate collection device includes an outer shell, a collection tube fixedly provided at one end of the outer shell, and a collection hole at the end of the collection tube; a rotating connector and a telescopic sleeve are provided inside the collection tube, the rotating connector is provided with multiple elastic plates, the telescopic sleeve is fitted over all the elastic plates, the inner wall of the telescopic sleeve slides in contact with the outer wall of the elastic plates, and the telescopic shaft of the telescopic drive mechanism is fixedly connected to the telescopic sleeve; the telescopic drive mechanism is used to drive the telescopic sleeve to move axially along the collection tube, thereby adjusting the distance between the collection head at the end of the elastic plate and the axis of the collection tube; a rotating drive mechanism is fixedly provided inside the outer shell, the rotating drive mechanism is connected to the rotating connector, and the rotating drive mechanism is used to rotate the connector, thereby exposing different collection heads from the collection hole; an air suction pipe is connected to the outer shell, the air suction pipe is used to connect to an air suction device, and a collection hose is connected to each collection head, the collection hose being connected to the air suction pipe. By setting a rotating connector, multiple elastic plates, and a telescopic sleeve, and cooperating with the rotating drive mechanism and the telescopic drive mechanism, the present invention enables multiple collection heads to extend out of the collection hole and reset sequentially. The operator only needs to insert the collection tube into the mouth once. By switching collection heads within the mouth, different heads can be sequentially extended from the collection orifice, allowing for the collection of exudate from multiple locations such as the gums, sublingual region, and buccal mucosa. This significantly simplifies the procedure, reduces patient mouth-opening time and discomfort, and is particularly suitable for applications requiring multi-point comparative analysis or large-area screening. Furthermore, unused collection heads remain enclosed within the collection tube during the collection process, physically isolated from the outside environment and the sampled area. Only the head in use extends from the collection orifice. This structural design effectively prevents accidental mixing of exudate from different collection sites, ensuring the uniqueness of each sample's origin and the accuracy of the test.

[0032] (2) The collection head of this oral mucosal exudate collection device is equipped with a spray chamber and spray holes. Before sample collection, the collection head being used is pressed tightly against the inner wall of the oral cavity through the flexible pad at its end, forming a closed collection chamber. The rinsing pump sprays rinsing fluid onto the target area. On the one hand, the rinsing fluid can moisten the oral mucosa and stimulate the production of local exudate; on the other hand, the exudate can dissolve in the rinsing fluid, forming a mixture which is then sucked into the storage chamber. This design solves the technical problem of traditional dry swabs being unable to effectively collect samples when the oral cavity is dry or the amount of exudate is small, greatly improving the collection success rate and avoiding the problem of low collection success rate of traditional dry swabs.

[0033] (3) The oral mucosal exudate collection device is also equipped with an irrigation nozzle inside the collection tube, and a spray hose is connected to the end of the irrigation nozzle. The end of the irrigation nozzle is also equipped with a flow sensor and a spray head. The spray head is connected to multiple collection heads one by one through a separate spray hose. The spray head is equipped with a micro-control valve, which can control the on / off state of each spray hose, so that the irrigation liquid in the irrigation nozzle flows to the spray hose connected to the collection head located in the collection hole. When the collection device sprays liquid, the micro-control valve in the spray head can control the irrigation liquid to enter the spray chamber in the collection head in use, and the flow sensor can record the amount of irrigation liquid sprayed to the target position before each collection. This can accurately record the dilution of the exudate at each sampling. In subsequent analysis, the concentration of the target component in the original exudate can be calculated backward based on the recorded dilution volume. This data provides key quantitative basis for clinical diagnosis or scientific research analysis, avoiding the deviation of the test results caused by unknown dilution ratio. Attached Figure Description

[0034] Figure 1 This is a schematic diagram of the overall structure of an oral mucosal exudate collection device according to an embodiment of the present invention.

[0035] Figure 2 This is an exploded view of an oral mucosal exudate collection device according to an embodiment of the present invention.

[0036] Figure 3 yes Figure 2 Enlarged view of point A in the middle.

[0037] Figure 4 This is a schematic diagram of the installation structure of the rotation drive motor of an oral mucosal exudate collection device according to an embodiment of the present invention.

[0038] Figure 5 This is a schematic diagram of the installation structure of the electric push rod of an oral mucosal exudate collection device according to an embodiment of the present invention.

[0039] Figure 6 This is a schematic diagram of the installation structure of the elastic plate of an oral mucosal exudate collection device according to an embodiment of the present invention.

[0040] Figure 7 This is a schematic diagram of the first cross-sectional structure of the collection head of an oral mucosal exudate collection device according to an embodiment of the present invention.

[0041] Figure 8 This is a schematic diagram of the second cross-sectional structure of the collection head of an oral mucosal exudate collection device according to an embodiment of the present invention.

[0042] Figure 9 This is a schematic diagram of the collection and storage box structure of an oral mucosal exudate collection device according to an embodiment of the present invention.

[0043] Figure 10 This is a flowchart of a method for collecting oral mucosal exudate according to an embodiment of the present invention.

[0044] In the above diagram: 100 - outer shell, 110 - collection tube, 111 - collection hole, 120 - cover, 121 - liquid spray connector, 122 - vacuum connector; 200 - rotating connector, 201 - rotating bearing, 210 - telescopic sleeve; 211 - telescopic connecting rod, 212 - electric push rod; 220 - driven gear ring; 230 - fixed end plate, 231 - through hole; 230 - fixed end plate; 300 - elastic plate, 301 - mounting end plate, 302 - collection mounting hole ; 400-Collection head, 401-Spray hole, 402-Spray chamber; 410-Flexible gasket ring; 500-Rotation drive motor, 501-Drive gear, 510-Motor retaining ring; 600-Collection storage box, 601-Collection retaining ring, 602-First end cap, 603-Second end cap, 604-Storage chamber; 610-Collection hose, 700-Flush nozzle, 701-Flow sensor, 702-Spray hose; 703-Spray head; 800-Air-permeable and water-resistant membrane. Detailed Implementation

[0045] The technical solutions of the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention.

[0046] In the description of this invention, it should be understood that the terms "center," "longitudinal," "lateral," "length," "width," "thickness," "upper," "lower," "front," "rear," "left," "right," "vertical," "horizontal," "top," "bottom," "inner," "outer," "clockwise," "counterclockwise," "axial," "radial," and "circumferential," etc., indicating orientation or positional relationships, are based on the orientation or positional relationships shown in the accompanying drawings and are only for the convenience of describing the invention and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation, and therefore should not be construed as a limitation of the invention. Furthermore, features defined with "first" or "second" may explicitly or implicitly include one or more of that feature. In the description of this invention, unless otherwise stated, "a plurality of" means two or more.

[0047] In the description of this invention, it should be noted that, unless otherwise explicitly specified and limited, the terms "installation," "connection," and "linking" should be interpreted broadly. For example, they can refer to a fixed connection, a detachable connection, or an integral connection; they can refer to a mechanical connection or an electrical connection; they can refer to a direct connection or an indirect connection through an intermediate medium; and they can refer to the internal connection of two components. Those skilled in the art can understand the specific meaning of the above terms in this invention based on the specific circumstances.

[0048] Please refer to Figures 1 to 9 The present invention discloses an oral mucosal exudate collection device, comprising a hollow cylindrical shell 100, a collection tube 110 fixedly disposed at one end of the shell 100, and a circular collection hole 111 at the end of the collection tube 110. The other end of the shell 100 is provided with an openable cover 120.

[0049] The outer shell 100 is provided with a rotating connector 200 and a telescopic sleeve 210. The rotating connector 200 is a hollow cylindrical tube. A rotating bearing 201 is provided on the outside of the rotating connector 200. The rotating connector 200 is rotatably mounted in the outer shell 100 through the rotating bearing 201. A fixed end plate 230 is fixedly provided at the end of the rotating connector 200. A through hole 231 is provided in the middle of the fixed end plate 230. The through hole 231 serves as a clearance. The rotating connector 200 is provided with multiple elastic plates 300. One end of each elastic plate 300 is fixedly connected to the rotating connector 200, and the other end is inclined outward, thus forming an elastic cantilever structure. Each elastic plate 300 has a mounting end plate 301 fixedly attached to its end (the cantilever end). The cantilever end of each elastic plate 300 extends into the collection tube 110. The mounting end plate 301 has a collection mounting hole 302. Each elastic plate 300 also has a collection head 400 fixedly attached to its end, which is fixed within the collection mounting hole 302 on the mounting end plate 301. One collection head 400 extends through the collection hole 111 and out of the collection tube 110; the collection head 400 extending out of the collection tube 110 is the one currently in operation. In this embodiment, there are four elastic plates 300 and four collection heads 400.

[0050] The rotating connector 200 is equipped with a telescopic drive mechanism. The telescopic sleeve 210 is fitted over all the elastic plates 300. The inner wall of the telescopic sleeve 210 slides in contact with the outer wall of the elastic plate 300. The telescopic shaft of the telescopic drive mechanism is fixedly connected to the telescopic sleeve 210 via a telescopic connecting rod 211. The telescopic drive mechanism is used to drive the telescopic sleeve 210 to move axially along the collection tube 110, thereby adjusting the distance between the collection head 400 at the end of the elastic plate 300 and the axis of the collection tube 110. A rotating drive mechanism is fixedly installed inside the outer shell 100. The rotating drive mechanism is connected to the rotating connector 200 and is used to rotate the connector 200, thereby exposing different collection heads 400 from the collection hole 111. In this embodiment, the telescopic drive mechanism is an electric push rod 212. The electric push rod 212 is fixed to the inner wall of the rotating connector 200, and the telescopic shaft of the electric push rod 212 is connected to the telescopic sleeve 210 via the telescopic connecting rod 211. The rotation drive mechanism is a rotation drive motor 500. The rotation drive motor 500 is fixed to the inner wall of the outer shell 100 by a motor fixing ring 510. A drive gear 501 is fixedly provided at the end of the rotation output shaft of the rotation drive motor 500. A driven gear ring 220 is provided at the end of the rotation connector 200. The drive gear 501 meshes with the driven gear ring 220.

[0051] It should be noted that the inner diameter of the sampling hole 111 is slightly larger than the outer diameter of the sampling head 400, which facilitates the extension and retraction of the sampling head 400.

[0052] In the above structure, the elastic plate 300 has greater elasticity. The distance between the ends of the plate fixed to the rotating connector 200 is relatively close, while the distance between the multiple cantilever ends is relatively far. When the telescopic sleeve 210 slides away from the rotating connector 200, the cantilever ends of all the elastic plates 300 will move closer to each other, which will cause the working acquisition head 400 to retract from the acquisition hole 111. Once all the acquisition heads 400 have retracted into the acquisition tube 110, the rotation drive mechanism drives the rotation connector 200 to rotate, causing all the elastic plates 300 and acquisition heads 400 to rotate within the acquisition tube 110. When the rotation drive mechanism drives the rotation connector 200 to rotate 90 degrees, another acquisition head 400 can then be directly facing the acquisition hole 111. Then, the telescopic drive mechanism drives the telescopic sleeve 210 to reset. At this point, the acquisition head 400 facing the acquisition hole 111 can move outward from the acquisition tube 110 under the elastic action of the elastic plate 300, thus exposing the acquisition hole 111. The remaining acquisition heads 400 are all confined within the acquisition tube 110, thus completing the switching of the acquisition heads 400.

[0053] The collection head 400 has a cylindrical structure with a funnel-shaped end. This collection device is externally connected to an air extraction device via an air extraction pipe 122, which is connected to the outer casing 100. The air extraction pipe 122 is used to connect to the air extraction device. Each collection head 400 has a collection hose 610 connected to its end, and the collection hose 610 is connected to the air extraction pipe 122. Specifically, the outer casing 100 also contains multiple collection storage boxes 600, which are fixed inside the collection pipe 110. Each collection storage box 600 contains multiple storage compartments 604. A storage chamber 604 is connected to a collection head 400 via a collection hose 610. The storage chamber 604 is connected to a suction tube 122. When the exudate collection device has finished working, the oral support device assists the patient in opening their mouth at a large angle. The working collection head 400 is then attached to the inner wall of the patient's mouth. The suction device is activated, and the collection head 400, connected to the suction device via the collection hose 610, generates suction, thereby drawing the exudate from the oral mucosa at the patient's collection point into the corresponding storage chamber 604 within the collection storage box 600, completing the collection process for one collection point. After completing the process for one collection point, the telescopic drive mechanism and the rotation drive mechanism work together to switch the collection head 400, allowing another collection head 400 to be switched into the collection hole 111. The collection head 400 that has completed its collection work retracts into the collection tube 110, thus enabling continuous sampling at the next collection location.

[0054] This invention, by incorporating a rotating connector 200, multiple elastic plates 300, and a telescopic sleeve 210, along with a rotating drive mechanism and a telescopic drive mechanism, enables multiple collection heads 400 to sequentially extend from and return to their original positions through the collection hole 111. The operator only needs to insert the collection tube 110 into the oral cavity once. Through a switching process within the oral cavity, different collection heads 400 can be sequentially extended from the collection hole 111, thus sequentially collecting exudate from multiple different locations such as the gums, sublingual region, and buccal mucosa. This significantly simplifies the operation process, reduces patient mouth-opening time and discomfort, and is particularly suitable for applications requiring multi-point comparative analysis or large-area screening. Furthermore, unused collection heads 400 and those that have completed the collection process are both enclosed within the collection tube 110, physically isolated from the outside environment and the sampled area. Only the collection head 400 in use extends from the collection hole 111. This structural design effectively prevents accidental mixing of exudate from different collection sites, ensuring the uniqueness of each sample's origin and the accuracy of the test.

[0055] In a preferred embodiment, the collection head 400 has a double-layer structure, and the inner wall of the collection head 400 is provided with an annular spray cavity 402; the inner wall of the collection head 400 is provided with a plurality of spray holes 401, the spray holes 401 are inclined and all the spray holes 401 are connected to the spray cavity 402; each collection head 400 is also connected to a spray hose 702 that is connected to the spray cavity 402; the collection tube 110 is also provided with a flushing spray pipe 700, and the spray hose 702 is connected to the end of the flushing spray pipe 700; the flushing spray pipe 700 is connected to a spraying device, wherein the spraying device is also an external device, the spraying device includes a storage tank and a flushing pump, the flushing pump is used to transport the flushing liquid in the storage tank to the spray hose 702 and spray it out from the spray hole 401. The rinsing solution can be physiological saline, and agents that promote the secretion of exudate from the oral mucosa, such as a low-concentration citric acid solution, can also be added to the rinsing solution. In this way, the rinsing solution can moisten the oral mucosa and stimulate the production of local exudate. The exudate can dissolve in the rinsing solution and form a mixture which is then drawn into the storage chamber 604, thus greatly improving the success rate of collection.

[0056] The flushing nozzle 700 is also equipped with a flow sensor 701 and a spray head 703 at its end. The spray head 703 contains a multi-channel micro-control valve, which controls the on / off state of the spray hose 702, ensuring that the flushing liquid in the flushing nozzle 700 flows only into the spray hose 702, which is connected to the working collection head 400. This guarantees that all the liquid passing through the spray head 703 is sprayed into the working collection head 400. The flow sensor 701 records the amount of liquid sprayed from the spray hose 702 each time. The micro-control valve is existing technology, and its structure and working principle are not described in detail here.

[0057] The oral mucosal exudate collection device has a collection head 400 with a spray chamber 402 and a spray orifice 401. Before sample collection, the collection head 400 is pressed against the inner wall of the oral cavity by a flexible gasket 410 at its end, forming a closed collection chamber. A rinsing pump sprays rinsing fluid onto the target area. On one hand, the rinsing fluid moistens the oral mucosa, stimulating the production of local exudate; on the other hand, the exudate dissolves in the rinsing fluid, forming a mixture that is then drawn into the storage chamber 604. This design solves the technical problem of traditional dry swabs being unable to effectively collect samples when the oral cavity is dry or the exudate volume is low, significantly improving the collection success rate and avoiding the low success rate of traditional dry swabs. Furthermore, the micro-control valve inside the spray head 703 controls the flow of rinsing fluid into the spray chamber 402 inside the collection head 400, and the flow sensor 701 records the amount of rinsing fluid sprayed onto the target location before each collection. This allows for accurate recording of the exudate dilution volume at each sampling point. Subsequent analysis can then use the recorded dilution volume to extrapolate the concentration of the target component in the original exudate. This data provides crucial quantitative evidence for clinical diagnosis and research analysis, avoiding deviations in test results caused by unknown dilution factors.

[0058] In a preferred embodiment, each of the collection heads 400 is provided with a flexible pad ring 410 at its end. When the collection head 400 is pressed against the inner wall of the patient's mouth, the flexible pad ring 410 can improve the patient's comfort and can flexibly fit the inner wall of the patient's mouth to ensure the sealing of the collection area, prevent the overflow of the rinsing fluid and the outflow of the exudate, and improve the accuracy and volume of exudate collection.

[0059] In a preferred embodiment, the data acquisition and storage box 600 is provided with a first end cap 602 and a second end cap 603 at both ends. The first end cap 602 is provided with a plurality of data acquisition connectors, each of which extends into a storage compartment 604.

[0060] Each sampling connector is connected to a storage chamber 604; the first end cap 602 is fixed inside the outer casing 100 by a sampling fixing ring 601, and each sampling hose 610 is connected to a sampling connector; this allows for a one-to-one connection between the storage chamber 604 and the sampling head 400. The second end cap 603 is connected to the suction pipe 122. The end of the sampling storage box 600 away from the first end cap 602 is provided with a breathable and water-resistant membrane 800; the second end cap 603 is fixed to the inner wall of the cover portion 120. When the suction device evacuates the suction pipe 122, the gas can pass through the breathable and water-resistant membrane 800, which generates suction in the sampling hose 610, while ensuring that the collected liquid (a mixture of exudate and flushing fluid) is retained in the sampling storage box 600. The sampling storage box 600, the first end cap 602, and the second end cap 603 are all snap-fit ​​structures that facilitate easy disengagement. When the cover 120 is opened, the collection and storage box 600 can be detached from the first end cover 602 and the second end cover 603, making it convenient to remove the collection and storage box 600 to obtain the collected sample.

[0061] The cover portion 120 is provided with a liquid spraying connector 121 and a vacuum connector 122, which are used to connect to an external liquid spraying device and a vacuum device, respectively.

[0062] It should be noted that the oral mucosal exudate collection device of the present invention also includes a control unit and a power supply. The power supply is used to supply power to electrical components such as the electric push rod 212, the rotary drive motor 500, and the micro-control valve. The control unit is used to control the coordinated operation of components such as the spraying device, the suction device, the electric push rod 212, the rotary drive motor 500, and the micro-control valve, and to acquire the detection data of the flow sensor 701.

[0063] refer to Figure 10 The present invention also provides a method for collecting oral mucosal exudate using the above-mentioned oral mucosal exudate collection device, the method comprising the following steps:

[0064] S1: Insert the collection tube 110 into the patient's oral cavity, so that the collection head 400, which is limited to the collection hole 111 of the collection tube 110, is pressed against the first collection position on the inner wall of the patient's oral cavity.

[0065] S2: The micro-control valve controls the opening of its internal channel, starts the flushing pump, and the flushing fluid is sprayed from the spray hole 401 of the collection head 400, which is limited in the collection hole 111, to flush the first collection position of the patient's oral cavity, so that the exudate of the first collection position of the patient's oral cavity flows into the first collection head 400 through the flushing fluid. The flow sensor 701 obtains the amount of flushing fluid sprayed.

[0066] S3: Start the air extraction device, which will pump the exudate and washing liquid into the corresponding storage compartment 604 for storage.

[0067] S4: Start the telescopic drive mechanism to move the telescopic sleeve 210 away from the rotating connector 200, thereby causing the acquisition head 400, which is confined in the acquisition hole 111, to retract into the acquisition tube 110.

[0068] S5: The rotary drive mechanism drives the rotary connector 200 to rotate at a certain angle, thereby moving the other acquisition head 400 to a position facing the acquisition hole 111; the telescopic drive mechanism is activated again, driving the telescopic sleeve 210 to approach the rotary connector 200, and the end of the elastic plate 300 with the acquisition hole 111 is elastically reset, so that the acquisition head 400 facing the acquisition hole 111 is exposed from the acquisition hole 111.

[0069] S6: Move the collection tube to position 110 and repeat steps S2-S5 multiple times to complete multi-point sampling of oral exudate.

[0070] The above description is only a preferred embodiment of the present invention, but the scope of protection of the present invention is not limited thereto. Any equivalent substitutions or modifications made by those skilled in the art within the scope of the technology disclosed in the present invention, based on the technical solution and inventive concept of the present invention, should be covered within the scope of protection of the present invention.

Claims

1. An oral transmucosal exudate collection device, comprising: It includes an outer shell (100), and a collection tube (110) is fixedly provided at the end of the outer shell (100). The collection tube (110) is provided with a collection hole (111) at the end. The collection tube (110) is provided with a rotating connector (200) and a telescopic sleeve (210). The rotating connector (200) is provided with a plurality of elastic plates (300). One end of the elastic plate (300) is fixedly connected to the rotating connector (200), and the other end is inclined outward. Each elastic plate (300) is fixedly provided with a collection head (400) at its end. One collection head (400) passes through the collection hole (111) and extends out of the collection tube (110). The rotating connector (200) is provided with a telescopic drive mechanism. The telescopic sleeve (210) is fitted over all the elastic plates (300). The inner wall of the telescopic sleeve (210) is in sliding contact with the outer wall of the elastic plate (300). The telescopic shaft of the telescopic drive mechanism is fixedly connected to the telescopic sleeve (210). The telescopic drive mechanism is used to drive the telescopic sleeve (210) to move axially along the collection tube (110), thereby adjusting the distance from the collection head (400) at the end of the elastic plate (300) to the axis of the collection tube (110). A rotation drive mechanism is fixedly provided inside the outer shell (100). The rotation drive mechanism is connected to the rotation connector (200). The rotation drive mechanism is used to rotate the connector (200) so that different collection heads (400) are exposed from the collection hole (111). An air extraction pipe (122) is connected to the outer casing (100). The air extraction pipe (122) is used to connect to the air extraction device. A collection hose (610) is connected to each collection head (400). The collection hose (610) is connected to the air extraction pipe (122).

2. The device of claim 1, wherein the device is configured to collect a sample of oral mucosal exudate. The inner wall of the collection head (400) is provided with a spray chamber (402); the inner wall of the collection head (400) is provided with a plurality of spray holes (401), all of which are connected to the spray chamber (402); each collection head (400) is also connected with a spray hose (702) that is connected to the spray chamber (402). The collection tube (110) is also provided with a flushing nozzle (700), and a spray hose (702) is connected to the end of the flushing nozzle (700); the flushing nozzle (700) is connected to a spraying device, which includes a storage tank and a flushing pump. The flushing pump is used to transport the flushing liquid in the storage tank to the spray hose (702) and spray it out from the spraying hole (401).

3. The oral mucosal exudate collection device according to claim 2, characterized in that, The flushing nozzle (700) is also equipped with a flow sensor (701) and a spray head (703) at its end. The spray head (703) is equipped with a micro-control valve, which is used to control the on / off state of the spray hose (702), so that the flushing liquid in the flushing nozzle (700) flows to the spray hose (702) which is connected to the collection head (400) located in the collection hole (111). The flow sensor (701) is used to record the amount of liquid sprayed by the spray hose (702) each time.

4. The oral mucosal exudate collection device according to claim 1, characterized in that, Each of the aforementioned acquisition heads (400) has a flexible gasket ring (410) at its end.

5. The oral mucosal exudate collection device according to claim 1, characterized in that, The outer casing (100) is also provided with a plurality of collection and storage boxes (600), which are fixed inside the collection tube (110). The collection and storage boxes (600) are fixed with a plurality of storage compartments (604), and each storage compartment (604) is connected to a collection head (400) through a collection hose (610).

6. The oral mucosal exudate collection device according to claim 5, characterized in that, The collection and storage box (600) is provided with a first end cap (602) and a second end cap (603) at both ends. The first end cap (602) is provided with a plurality of collection connectors, each of which is connected to a storage chamber (604). The first end cap (602) is fixed inside the outer shell (100) by a collection fixing ring (601). Each collection hose (610) is connected to a collection connector. The second end cap (603) is connected to an air extraction pipe (122).

7. The oral mucosal exudate collection device according to claim 6, characterized in that, The end of the collection and storage box (600) away from the first end cover (602) is provided with a breathable and water-resistant membrane (800). The outer casing (100) has an openable cover (120) at one end.

8. The oral mucosal exudate collection device according to claim 6, characterized in that, The telescopic drive mechanism is an electric push rod (212), which is fixed to the inner wall of the rotating connector (200). The telescopic shaft of the electric push rod (212) is connected to the telescopic sleeve (210) through the telescopic connecting rod (211).

9. The oral mucosal exudate collection device according to claim 6, characterized in that, The rotation drive mechanism is a rotation drive motor (500). The rotation drive motor (500) is fixed to the inner wall of the outer shell (100) by a motor fixing ring (510). A drive gear (501) is fixedly provided at the end of the rotation output shaft of the rotation drive motor (500). The rotating connector (200) has a driven gear ring (220) at its end, and the driving gear (501) meshes with the driven gear ring (220).

10. A method for collecting oral mucosal exudate using a collection device, characterized in that, The collection method uses the oral mucosal exudate collection device as described in any one of claims 1-9, and the method includes the following steps: S1: Insert the collection tube (110) into the patient's oral cavity, so that the collection head (400) located in the collection hole (111) of the collection tube (110) is pressed against the first collection position on the inner wall of the patient's oral cavity; S2: Start the flushing pump, and the flushing fluid is sprayed from the spray hole (401) of the collection head (400) which is limited to the collection hole (111) to flush the first collection position of the patient's oral cavity, so that the exudate at the first collection position of the patient's oral cavity flows into the first collection head (400) through the flushing fluid; the flow sensor (701) obtains the amount of flushing fluid sprayed. S3: Start the air extraction device, which will pump the exudate and washing liquid into the corresponding storage compartment (604) for storage; S4: Start the telescopic drive mechanism to drive the telescopic sleeve (210) to move away from the rotating connector (200), thereby causing the acquisition head (400) confined in the acquisition hole (111) to retract into the acquisition tube (110). S5: The rotating drive mechanism drives the rotating connector (200) to rotate a certain angle, thereby moving the other sampling head (400) to the position facing the sampling hole (111); the telescopic drive mechanism is activated again, driving the telescopic sleeve (210) to approach the rotating connector (200), and the end of the elastic plate (300) with the sampling hole (111) is elastically reset, so that the sampling head (400) facing the sampling hole (111) is exposed from the sampling hole (111); S6: Move the collection tube (110) to the position and repeat steps S2-S5 multiple times to complete the multi-point sampling of oral effusion.

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