Whole blood detection device integrated with self-negative pressure and surface modification flow aiding structure

Abstract

The embodiment of the invention discloses a whole blood detection device integrated with a self-negative-pressure and surface-modified flow aiding structure, relates to the technical field of biological detection, and can effectively improve the detection efficiency of a whole blood sample. The device comprises a plate piece, a sealing piece and a filtering piece, the plate is provided with a containing cavity, one side of the plate is further provided with a sample adding opening, the sample adding opening is communicated with the containing cavity, a detection agent is arranged in the containing cavity, and a flow assisting structure is further arranged in the containing cavity and used for guiding flow of an object to be detected; the sealing piece plugs the sample adding opening; the filtering piece is arranged in a space defined by the sealing piece and the plate piece, a collecting cavity is formed between the filtering piece and the sealing piece, and the air pressure in the collecting cavity is lower than the atmospheric pressure. The method is suitable for the scene of rapid blood detection.

Description

Technical Field

[0001] The present application relates to the field of biological detection technology, and in particular to a whole blood detection device integrating self-negative pressure and surface modified flow-aiding structure. Background Art

[0002] When testing whole blood samples, commonly used test objects include serum or red blood cells, which are usually obtained from whole blood samples through tedious blood processing steps, which takes a long time. However, the clinical requirements for rapid blood testing are becoming increasingly high, especially in departments such as emergency departments and ICUs, which require test reports to be issued within a short time after blood collection. Summary of the Invention

[0003] In view of this, the present application provides a whole blood testing device that integrates self-negative pressure and surface-modified flow-aiding structures to improve the detection efficiency of whole blood samples.

[0004] In the first aspect, an embodiment of the present invention provides a whole blood detection device integrating self-negative pressure and surface modified flow-aiding structure, comprising: a plate, wherein the plate is provided with a accommodating cavity, and a sample addition port is provided on one side of the plate, the sample addition port is communicated with the accommodating cavity, a detection agent is provided in the accommodating cavity, and a flow-aiding structure is provided in the accommodating cavity, and the flow-aiding structure is used to guide the object to be tested; a sealing member, wherein the sealing member blocks the sample addition port; a filter member, wherein the filter member is arranged in the space enclosed by the sealing member and the plate, and a collection cavity is formed between the filter member and the sealing member, and the air pressure in the collection cavity is lower than the atmospheric pressure.

[0005] In a specific embodiment, the accommodating chamber includes a main chamber and at least one sub-chamber, the sub-chamber is communicated with the main chamber, and the detection agent is disposed in the sub-chamber.

[0006] In a specific embodiment, the flow-aiding structure is arranged on the inner wall of the accommodating cavity, and the flow-aiding structure is hydrophilic.

[0007] In a specific embodiment, the plate member includes an intermediate plate body, an upper plate body, and a lower plate body. The intermediate plate body is located between the upper plate body and the lower plate body, and a first adhesive layer is provided between the intermediate plate body and the upper plate body, and a second adhesive layer is provided between the intermediate plate body and the lower plate body. The sample loading port is provided on the upper plate body.

[0008] In a specific embodiment, the sealing member is groove-shaped, with the groove opening of the sealing member facing the plate member, the groove bottom of the sealing member facing away from the plate body, and the filter member is arranged in the groove opening of the sealing member.

[0009] In a specific embodiment, the filter element is groove-shaped, and the groove opening of the filter element faces the sealing element, and the groove bottom of the filter element extends into the accommodating cavity.

[0010] In a specific embodiment, the plate is at least partially made of a transparent material, and / or the sealing element is made of a transparent material.

[0011] In a specific embodiment, the filter element is made of a filter membrane with a pore diameter of no more than 1 μm, and the material of the filter membrane includes polycarbonate PC, aqueous polyethersulfone PES, mixed cellulose MCE, and polytetrafluoroethylene PTFE.

[0012] In a specific embodiment, the flow-aiding structure undergoes at least one of the following treatment processes: oxygen plasma surface modification treatment, vacuum treatment, and surface growth of hydrophilic groups, wherein the hydrophilic groups include hydroxyl groups.

[0013] In the second aspect, an embodiment of the present invention provides a detection method for a whole blood detection device integrating self-negative pressure and surface modified flow-aiding structure, comprising: using a needle with a whole blood sample to break the seal, so that under the negative pressure of the collection chamber, the whole blood sample separates from the needle and enters the collection chamber, and passes through the filtering action of the filter element. The object to be tested in the whole blood sample passes through the filter element and enters the accommodating chamber. Under the guiding action of the flow-aiding structure on the inner wall of the accommodating chamber, the object to be tested is guided to the position of the detection agent; according to the reaction result of the object to be tested and the detection agent, the detection result of the whole blood sample is determined.

[0014] The embodiment of the present invention provides a whole blood detection device with integrated self-negative pressure and surface modified flow-aiding structure, including a plate, a seal, and a filter; the plate is provided with a accommodating cavity, and a sample addition port is also provided on one side of the plate, the sample addition port is connected to the accommodating cavity, a detection agent is provided in the accommodating cavity, and a flow-aiding structure is also provided in the accommodating cavity, and the flow-aiding structure is used to guide the object to be tested; the seal blocks the sample addition port; the filter is arranged in the space surrounded by the seal and the plate, and a collection cavity is formed between the filter and the seal, and the air pressure in the collection cavity is lower than the atmospheric pressure, thereby forming a negative pressure lower than the atmospheric pressure, and the whole blood sample from the needle tube that pierces the seal can be quickly added to the collection cavity, and the filter passes through the object to be tested in the whole blood sample, and the flow-aiding structure in the accommodating cavity guides the object to be tested to the detection agent for rapid testing, thereby effectively improving the detection efficiency of the whole blood sample. BRIEF DESCRIPTION OF THE DRAWINGS

[0015] In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the following briefly introduces the drawings required for use in the embodiments or the description of the prior art. Obviously, the drawings described below are only some embodiments of the present invention. For ordinary technicians in this field, other drawings can be obtained based on these drawings without paying any creative work.

[0016] Figure 1 A schematic diagram of the composition of a whole blood testing device with integrated self-negative pressure and surface-modified flow-aiding structure provided in an embodiment of the present application; Figure 2 This is a schematic diagram of a whole blood testing device that integrates self-negative pressure and surface-modified flow-aiding structures provided in an embodiment of the present application.

[0017] Description of main reference numerals: 100-whole blood testing device; 10-plate; 101-sample addition port; 102-accommodating chamber; 1020-main chamber; 1021-sub-chamber; 103-middle plate; 104-upper plate; 105-lower plate; 106-first adhesive layer; 107-second adhesive layer; 20-seal; 30-filter; 40-needle tube. DETAILED DESCRIPTION

[0018] The embodiments of the present invention are described in detail below with reference to the accompanying drawings.

[0019] It should be understood that the embodiments described are only a portion 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 persons of ordinary skill in the art without creative work are within the scope of protection of the present invention.

[0020] The traditional whole blood sample testing process is cumbersome and time-consuming, while the clinical requirements for rapid blood testing are getting higher and higher. To solve this problem, firstly, Figure 1 As shown, an embodiment of the present invention provides a whole blood testing device 100 integrating self-negative pressure and surface modified flow-aiding structure, and the device may include: a plate 10, a sealing element 20, and a filter element 30.

[0021] The plate 10 is provided with a accommodating chamber 102, and a sample addition port 101 is provided on one side of the plate 10. The sample addition port 101 is connected to the accommodating chamber 102, so that it is convenient to add a whole blood sample through the sample addition port 101; a detection agent is provided in the accommodating chamber 102, and the detection agent is used to detect the object to be detected in the whole blood sample. The detection agent can be solidified at a preset position in the accommodating chamber 102; and a flow-aiding structure is also provided in the accommodating chamber 102, and the flow-aiding structure is used to guide the object to be detected. For example, when the object to be detected in the whole blood sample is serum, the flow-aiding structure can be used to quickly guide the serum to the position of the detection agent in the accommodating chamber 102, thereby further improving the detection speed.

[0022] The seal 20 blocks the sample addition port 101, thereby protecting the detection agent and the like in the accommodating cavity 102 of the plate body to prevent biological contamination, and facilitates the formation of a preset air pressure in the space enclosed by the seal 20 and the plate 10. For example, the preset air pressure can be lower than atmospheric pressure, thereby forming a negative pressure environment. The filter element 30 is arranged in the space surrounded by the seal 20 and the plate 10, and a collection chamber is formed between the filter element 30 and the seal 20. The air pressure in the collection chamber is lower than the atmospheric pressure. The filter element 30 is used to filter the whole blood sample added to the collection chamber, so that the object to be tested passes through the filter element 30 and is guided to the location of the detection agent by the flow-aiding structure in the accommodating chamber 102. When the seal 20 is pierced by the needle tube 40 and the whole blood sample is added to the collection chamber, in order to facilitate the whole blood sample to quickly fall into the collection chamber from the needle tube 40, in this embodiment, the air pressure in the collection chamber is lower than the atmospheric pressure of the environment in which the device is used. This can form a negative pressure effect in the collection chamber, so that under the pressure difference between the collection chamber and the ambient atmospheric pressure, the whole blood sample can quickly detach from the needle tube 40 and be added to the collection chamber, thereby improving the use efficiency and detection efficiency of the device and the detection efficiency of the whole blood sample. In addition, the air pressure in the accommodating chamber 102 can also be set to be lower than atmospheric pressure; for example, the air pressure in the accommodating chamber 102 can be the same as the pressure in the collecting chamber, so as to facilitate production and processing, and not affect the filtration speed of the filter element 30; in some embodiments, when the filter element 30 has air pressure isolation capability, the air pressure in the accommodating chamber 102 can also be lower than the pressure in the collecting chamber, so that under the pressure difference between the collecting chamber and the accommodating chamber 102, the object to be tested in the whole blood sample can pass through the filter element 30 faster, thereby further improving the filtration speed of the filter element 30.

[0023] The embodiment of the present invention provides a whole blood testing device 100 with an integrated self-negative pressure and surface modified flow-aiding structure, comprising a plate 10, a sealing member 20, and a filter 30; the plate 10 is provided with a receiving cavity 102, and a sample injection port 101 is provided on one side of the plate 10, the sample injection port 101 is connected to the receiving cavity 102, a detection agent is provided in the receiving cavity 102, and a flow-aiding structure is provided in the receiving cavity 102, the flow-aiding structure is used to guide the flow of the object to be tested; the sealing member 20 blocks the sample injection port 101; the filter 30 is provided with a filter ... The filter element 30 is arranged in the space enclosed by the sealing element 20 and the plate element 10, and a collection chamber is formed between the filter element 30 and the sealing element 20. The air pressure in the collection chamber is lower than the atmospheric pressure, thereby forming a negative pressure lower than the atmospheric pressure. The whole blood sample from the needle tube 40 that pierces the sealing element 20 can be quickly added to the collection chamber, and the filter element 30 passes through the object to be tested in the whole blood sample. The flow-aiding structure in the accommodating chamber 102 guides the object to be tested to the detection agent for rapid detection, thereby effectively improving the detection efficiency of the whole blood sample.

[0024] To improve the detection capability of the whole blood testing device 100 and enable testing of multiple blood indicators at a time, optionally, in one embodiment of the present invention, the receiving chamber 102 includes a main chamber 1020 and at least one sub-chamber 1021, wherein the sub-chamber 1021 is connected to the main chamber 1020 and the detection agent is disposed within the sub-chamber 1021. For example, the receiving chamber 102 may be configured with multiple sub-chambers 1021, which surround the main chamber 1020. After being filtered by the filter element 30, the test object in the whole blood sample enters the main chamber 1020 and is then guided by the flow-aiding structure to flow into the multiple sub-chambers 1021 of the receiving chamber 102. Detection agents with different detection functions may be disposed within each sub-chamber 1021, thereby enabling testing of multiple blood indicators in a single whole blood testing operation.

[0025] Optionally, in one embodiment of the present invention, the flow-aiding structure is arranged on the inner wall of the accommodating chamber 102, and the flow-aiding structure is hydrophilic. Optionally, in one embodiment of the present invention, the flow-aiding structure undergoes at least one of the following treatment processes: oxygen plasma surface modification treatment, vacuum treatment, surface growth of hydrophilic groups, the hydrophilic groups include hydroxyl groups or other hydrophilic groups, etc., to ensure that the flow-aiding structure arranged on the inner wall of the accommodating chamber is hydrophilically treated so as to have a better diversion effect. The flow-aiding structure is arranged on the inner wall of the accommodating chamber 102, and the surface of the flow-aiding structure is modified. For example, the flow-aiding structure can be a flow-aiding layer arranged on the inner wall of the accommodating chamber 102. This not only simplifies the structure of the device, but also helps the whole blood sample to be tested to circulate quickly in the accommodating chamber 102 and be smoothly diverted to the location of the detection agent.

[0026] In order to further improve the machinability of the whole blood testing device 100 and reduce production costs, optionally, in one embodiment of the present invention, the plate 10 includes an intermediate plate body 103, an upper plate body 104, and a lower plate body 105, the intermediate plate body 103 is located between the upper plate body 104 and the lower plate body 105, and a first adhesive layer 106 is provided between the intermediate plate body 103 and the upper plate body 104, a second adhesive layer 107 is provided between the intermediate plate body 103 and the lower plate body 105, and the sample port 101 is provided on the upper plate body 104. This split structure facilitates the processing of the accommodating cavity 102, and a flow-aiding structure is set on the inner wall of the accommodating cavity 102. For example, a through cavity running through the upper and lower sides can be opened in the middle plate 103, and a flow-aiding structure is set on the inner wall of the through cavity. The upper plate 104 is connected to the upper side of the middle plate 103 by using the first adhesive layer 106, and the lower plate 105 is connected to the lower side of the middle plate 103 by using the second adhesive layer 107. The upper plate 104, the middle plate 103, and the lower plate 105 form the accommodating cavity 102. It can be seen that this structure simplifies the processing technology and is conducive to reducing the use cost of the whole blood detection device 100.

[0027] Optionally, in one embodiment of the present invention, the sealing member 20 is groove-shaped, and the groove of the sealing member 20 faces the plate 10, the groove bottom of the sealing member 20 faces away from the plate body, and the filter 30 is arranged in the groove of the sealing member 20. Figure 1 As shown, the groove of the groove-shaped sealing member 20 is buckled on one side of the plate 10 and blocks the sample addition port 101 , and the filter 30 is arranged in the groove of the sealing member 20 . This structure is convenient for processing and assembly, and is conducive to further improving the economy of the whole blood testing device 100 .

[0028] Optionally, in one embodiment of the present invention, the filter element 30 is groove-shaped, with the groove opening of the filter element 30 facing the sealing element 20, and the bottom of the groove of the filter element 30 extending into the accommodating cavity 102. The bottom of the groove of the groove-shaped filter element 30 (not shown) extends into the accommodating cavity 102, thereby forming a sufficient opposing surface between the groove wall of the filter element 30 and the inner wall of the accommodating cavity 102. The opposing surfaces can be separated by a predetermined distance or can be in contact. As a result, after the whole blood sample is filtered by the filter element 30, the object to be tested that passes through the filter element 30 can be promptly and quickly guided by the flow-aiding structure provided on the inner wall of the accommodating cavity 102, thereby further improving the filtration speed of the filter element 30.

[0029] Optionally, in one embodiment of the present invention, the plate 10 is at least partially made of a transparent material, and / or the seal 20 is made of a transparent material. For example, when the detection principle of the detection agent is based on a photosensitivity reaction, the plate 10 and / or the seal 20 can be configured as a transparent material to provide the whole blood testing device 100 with better light transmittance, thereby ensuring the photosensitivity reaction speed of the detection agent and improving detection efficiency.

[0030] Optionally, in one embodiment of the present invention, filter element 30 is made of a filter membrane with a pore diameter no greater than 1 μm. The filter membrane materials include polycarbonate (PC), aqueous polyethersulfone (PES), mixed cellulose (MCE), and polytetrafluoroethylene (PTFE). Filter element 30 can be a membrane structure, for example, made of a PC membrane with a pore diameter of 0.8 μm. This separates and filters blood cells from a whole blood sample, retaining them in the collection chamber for subsequent testing. Serum passes through filter element 30 into chamber 102 and is guided by the flow-aiding structure to the location of the detection reagent.

[0031] The whole blood testing device 100 of this embodiment does not require an external pump, and utilizes the negative pressure in the collection chamber and the diversion effect of the flow-assisting structure to achieve pre-treatment filtration of whole blood and one-time testing of multiple biochemical indicators.

[0032] In a second aspect, an embodiment of the present invention provides a detection method for a whole blood detection device integrating self-negative pressure and surface modified flow-aiding structure. When using the whole blood detection device 100, as shown in FIG. Figure 2 As shown, a whole blood sample can be drawn with a needle 40, and the needle pierces the seal 20. Under the negative pressure of the collection chamber, the whole blood sample quickly separates from the needle, and is filtered by the filter 30. The object to be tested in the whole blood sample, such as serum, enters the receiving chamber 102, while large impurities such as blood cells are filtered by the filter 30 and remain in the collection chamber; since the flow-aiding structure provided on the inner wall of the receiving chamber 102 is hydrophilic, the strong hydrophilic force of the flow-aiding structure can quickly guide and draw the object to be tested to the location of the detection agent for detection reaction. This operation process can ensure the accurate and high-speed flow of the object to be tested in the whole blood sample from the needle tip to the location of the detection agent, thereby forming a safe and complete whole blood detection process and effectively preventing biological contamination.

[0033] The whole blood testing device 100 can be integrated into a structural size of 14 mm × 20 mm × 3.6 mm. It is small in size, easy to carry, simple to operate, low in cost, and has a wide range of application scenarios.

[0034] It should be noted that, in this document, relational terms such as first and second, etc., are used only to distinguish one entity or operation from another entity or operation, and do not necessarily require or imply the existence of any such actual relationship or order between these entities or operations. Moreover, the terms "comprises," "comprising," or any other variants thereof are intended to cover non-exclusive inclusion, so that a process, method, article, or device comprising a series of elements includes not only those elements, but also other elements not explicitly listed, or elements inherent to such process, method, article, or device. In the absence of further limitations, an element defined by the phrase "comprising a ..." does not exclude the presence of other identical elements in the process, method, article, or device comprising the element.

[0035] Each embodiment in this specification is described in a related manner. The same or similar parts between the embodiments can be referred to each other. Each embodiment focuses on the differences from other embodiments.

[0036] In particular, for the device embodiment, since it is basically similar to the method embodiment, the description is relatively simple, and the relevant parts can be referred to the partial description of the method embodiment.

[0037] For the convenience of description, the above device is described as being divided into various units / modules based on their functions. Of course, when implementing the present invention, the functions of each unit / module can be implemented in the same or multiple software and / or hardware.

[0038] The above description is merely a specific embodiment of the present invention, but the scope of protection of the present invention is not limited thereto. Any changes or substitutions that can be easily conceived by a person skilled in the art within the technical scope disclosed in the present invention should be included in the scope of protection of the present invention. Therefore, the scope of protection of the present invention should be based on the scope of protection of the claims.

Claims

1. A whole blood testing device integrating self-negative pressure and surface modified flow-aiding structure, characterized in that: include: A plate, wherein the plate is provided with a receiving cavity, a sample adding port is further provided on one side of the plate, the sample adding port is communicated with the receiving cavity, a detection agent is provided in the receiving cavity, and a flow-aiding structure is further provided in the receiving cavity, the flow-aiding structure is used to guide the object to be detected; A sealing member, the sealing member sealing the sample addition port; A filter element is disposed in a space surrounded by the sealing element and the plate element, and a collecting chamber is formed between the filter element and the sealing element, wherein the air pressure in the collecting chamber is lower than the atmospheric pressure.

2. The whole blood testing device with integrated self-negative pressure and surface modified flow-aiding structure as claimed in claim 1, characterized in that: The containing chamber comprises a main chamber and at least one sub-chamber, the sub-chamber is communicated with the main chamber, and the detection agent is arranged in the sub-chamber.

3. The whole blood testing device with integrated self-negative pressure and surface modified flow-aiding structure as claimed in claim 1, characterized in that: The flow-aiding structure is arranged on the inner wall of the accommodating cavity, and the flow-aiding structure is hydrophilic.

4. The whole blood testing device with integrated self-negative pressure and surface modified flow-aiding structure as claimed in claim 1, characterized in that: The plate member includes an intermediate plate body, an upper plate body, and a lower plate body. The intermediate plate body is located between the upper plate body and the lower plate body, and a first adhesive layer is provided between the intermediate plate body and the upper plate body, and a second adhesive layer is provided between the intermediate plate body and the lower plate body. The sample loading port is provided on the upper plate body.

5. The whole blood testing device with integrated self-negative pressure and surface modified flow-aiding structure as claimed in claim 1, characterized in that: The sealing member is groove-shaped, and the groove opening of the sealing member faces the plate member, the groove bottom of the sealing member faces away from the plate body, and the filter member is arranged at the groove opening of the sealing member.

6. The whole blood testing device with integrated self-negative pressure and surface modified flow-aiding structure as claimed in claim 1, characterized in that: The filter element is in a groove shape, and the groove opening of the filter element faces the sealing element, and the groove bottom of the filter element extends into the accommodating cavity.

7. The whole blood testing device with integrated self-negative pressure and surface modified flow-aiding structure as claimed in claim 1, characterized in that: The plate is at least partially made of a transparent material, and / or the sealing element is made of a transparent material.

8. The whole blood testing device with integrated self-negative pressure and surface modified flow-aiding structure as claimed in claim 1, characterized in that: The filter element is made of a filter membrane with a pore diameter not greater than 1 μm, and the materials of the filter membrane include polycarbonate PC, water-based polyethersulfone PES, mixed cellulose MCE, and polytetrafluoroethylene PTFE.

9. The whole blood testing device with integrated self-negative pressure and surface modified flow-aiding structure as claimed in claim 1, characterized in that: The flow-aiding structure undergoes at least one of the following treatment processes: oxygen plasma surface modification treatment, vacuum treatment, and surface growth of hydrophilic groups, wherein the hydrophilic groups include hydroxyl groups.

10. A detection method of a whole blood detection device integrating self-negative pressure and surface modified flow-aiding structure as claimed in any one of claims 1 to 9, characterized in that: include: The sealing member is broken by using a needle with a whole blood sample, so that under the negative pressure of the collecting chamber, the whole blood sample separates from the needle and enters the collecting chamber, and is filtered by the filter element. The object to be tested in the whole blood sample passes through the filter element and enters the containing chamber, and under the guiding effect of the flow-aiding structure on the inner wall of the containing chamber, the object to be tested is guided to the position of the detection agent; the detection result of the whole blood sample is determined according to the reaction result between the object to be tested and the detection agent.

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