Enclosed chip consumable

Abstract

The utility model discloses a closed chip consumable, including main part, be equipped with sample inlet, pre dilution area, ration area, mixing area and detection unit on the main part, and pre dilution area includes premixing cavity and premixing fluid channel with its export intercommunication, and mixing area includes mixing cavity and mixing fluid channel with its export intercommunication, sample inlet, premixing cavity, premixing fluid channel, ration area, mixing cavity, mixing fluid channel and detection unit sequence connection, and premixing cavity and mixing cavity all store reagent in, and premixing cavity and mixing cavity can be pressed and moved, and after pressing and moving, the content in it is mixed in it. This consumable can realize zero contact operation, can avoid cross contamination and operating error, and shorten the detection time. Moreover, premixing cavity can handle sample in advance and then make sample enter each mixing cavity and handle, this can reduce the structure size of each mixing cavity, thereby reduce the structure size of consumable.

Description

Technical Field

[0001] This utility model relates to the field of medical testing technology, specifically to a closed-type chip consumable. Background Technology

[0002] A routine blood test typically includes more than 20 indicators, the most important of which are red blood cell count, white blood cell count and five-part differential, platelet count and hemoglobin count. Immune tests mainly include CRP, SAA and other tests.

[0003] Current technologies for routine blood tests primarily rely on blood smear microscopy and semi-automatic / fully automated hematology analyzers. Smear microscopy involves manual preparation, staining, and observation of smears, which is time-consuming and requires highly experienced operators, making it prone to errors due to subjective judgment. Fully automated hematology analyzers offer high efficiency, but also suffer from operational complexity, time consumption, high equipment costs, and large sample requirements, limiting their widespread adoption in primary healthcare settings.

[0004] To meet the needs of primary healthcare for blood analysis, existing technologies have developed box-type test kits and analytical instruments and methods based on them. However, existing box-type test kits mainly adopt an "open plastic container + pipetting workstation" testing mode. The process is as follows: the operator needs to manually open the cap of the collected blood sample and place it in the pipetting workstation. The robotic arm will then pick up the sample and inject it into the consumable inlet. Subsequently, the workstation will add diluent, staining agent, and other reagents in sequence. Although this scheme can achieve automation, it has significant drawbacks: (1) the open container poses a very high risk of contamination; (2) the working principle of pipetting requires the equipment to have a complex process of moving to transfer the liquid, which prolongs the testing time; (3) for some tests with a large blood dilution ratio, such as red blood cell testing, the blood dilution ratio is 500-700 times, and CRP / SAA immunoassay, the blood dilution ratio is 300-500 times. In order to achieve the required dilution ratio, the size of the corresponding cavity needs to be increased, which makes the test kit larger and less portable. Utility Model Content

[0005] The purpose of this invention is to address the shortcomings of existing technologies by providing a closed-loop chip consumable.

[0006] To achieve the above objectives, the technical solution adopted by this utility model is as follows:

[0007] A closed-loop chip consumable includes a main body, on which a sample inlet, a pre-dilution zone, a quantification zone, a mixing zone, and a detection unit are disposed. The pre-dilution zone includes a pre-mixing chamber and a pre-mixing fluid channel communicating with the outlet of the pre-mixing chamber. The mixing zone includes a mixing chamber and a mixing fluid channel communicating with the outlet of the mixing chamber.

[0008] The sample inlet, the premixing chamber, the premixing fluid channel, the quantitative zone, the mixing chamber, the mixing fluid channel, and the detection unit are connected in sequence.

[0009] The premixing chamber and the mixing chamber respectively store reagents. The premixing chamber can be pressed, and after pressing, the contents therein are mixed to form a premixed fluid. The mixing chamber can be pressed, and after pressing, the contents therein are mixed to form a mixed fluid.

[0010] In some embodiments, the premixed fluid channel has a blocked state and an unblocked state. When it is in the blocked state, the premixing chamber and the metering zone are isolated. When it is in the unblocked state, the premixing chamber and the metering zone are connected.

[0011] And / or, the mixing fluid channel has a blocked state and a non-blocked state. When it is in the blocked state, the mixing chamber is isolated from the detection unit. When it is in the non-blocked state, the mixing chamber is connected to the detection unit.

[0012] In some embodiments, the quantitative zone includes a quantitative cavity and a sample outlet channel communicating with the quantitative cavity, the quantitative cavity being connected to the premixed fluid channel, and the sample outlet channel being connected to the mixing cavity;

[0013] The sample outlet channel has a blocked state and an unblocked state. When it is in the blocked state, the mixing chamber and the quantitative chamber are disconnected. When it is in the unblocked state, the mixing chamber and the quantitative chamber are connected.

[0014] In some embodiments, multiple sets of the quantification zone, the mixing zone, and the detection unit are provided in a one-to-one correspondence, and the pre-dilution zone is connected to multiple sets of the quantification zone respectively.

[0015] In some embodiments, the main body is further provided with a distribution cavity, which is located between the premixing cavity and each of the metering cavities. Fluid flowing out of the premixing cavity is distributed through the distribution cavity and then enters each of the metering cavities.

[0016] In some embodiments, the cross-sectional area of ​​the metering cavity is larger than that of the dispensing cavity, and the main body is further provided with an overflow cavity communicating with the dispensing cavity. The distance between the inlet of each metering cavity and the inlet of the dispensing cavity is smaller than the distance between the inlet of the overflow cavity and the inlet of the dispensing cavity.

[0017] In some embodiments, one end of both the metering cavity and the overflow cavity extends to the outside of the main body, and each of the metering cavity and the overflow cavity is slidably provided with a plug for sealing.

[0018] In some embodiments, the quantitative chamber and the sample outlet channel are connected through an exhaust port formed on the main body, and a waterproof and breathable membrane is provided at the exhaust port.

[0019] In some embodiments, the premixed fluid channel, the sample outlet channel, and the mixed fluid channel are each provided with a sealing structure that can be broken by fluid pressure. The main body includes a base plate, a lower membrane bonded to the base plate, and an upper membrane bonded to the lower membrane. The premixed fluid channel, the sample outlet channel, and the mixed fluid channel are all at least partially formed between the upper membrane and the lower membrane. The upper membrane and the lower membrane located at the premixed fluid channel, the sample outlet channel, and the mixed fluid channel are partially bonded together to form the sealing structure.

[0020] In some embodiments, the premixing chamber includes a first premixing chamber and a second premixing chamber, the first premixing chamber and the second premixing chamber are connected by a narrow channel, the premixed fluid channel is connected to the second premixing chamber, and the sample inlet is connected to the first premixing chamber;

[0021] The mixing chamber includes a first mixing chamber and a second mixing chamber, which are connected by a narrow channel. The mixing fluid channel is connected to the second mixing chamber, and the metering zone is connected to the first mixing chamber.

[0022] In some embodiments, the detection unit includes a first detection unit, which includes a first detection chamber, a waste liquid passage, and a waste liquid chamber connected in sequence, with the first detection chamber corresponding to the mixed fluid passage.

[0023] In some embodiments, the first detection cavity is a flat cavity; and / or, the height of the first detection cavity is 0.1–0.4 mm; and / or, the cross-sectional area of ​​the first detection cavity is 50–70 mm². 2 ; and / or, the volume of the first detection chamber is 10 to 25 μL.

[0024] In some embodiments, the first detection chamber has an inlet for the inflow of a fluid sample and an outlet for the outflow of a fluid sample, both the inlet and the outlet of the first detection chamber being located at the bottom of the first detection chamber, and the distance between the inlet and the outlet of the first detection chamber being the greatest at the bottom of the first detection chamber.

[0025] In some embodiments, the first detection unit further includes a buffer cavity disposed between the mixing fluid channel and the first detection cavity, the buffer cavity being in communication with both the mixing fluid channel and the first detection cavity, and the flow direction of the fluid in the buffer cavity being perpendicular to the flow direction of the fluid in the mixing fluid channel.

[0026] In some embodiments, the detection unit further includes a second detection unit, which includes a temporary storage chamber, a second detection chamber, and a waste liquid chamber. A test strip is disposed in the second detection chamber. The temporary storage chamber is connected to the second detection chamber and the waste liquid chamber respectively. The temporary storage chamber and the mixed fluid channel are connected in a one-to-one correspondence.

[0027] In some embodiments, the detection unit further includes a third detection unit, which includes a third detection chamber for performing absorbance detection, and the third detection chamber and the mixing fluid channel are connected in a one-to-one correspondence.

[0028] In some embodiments, the main body is further provided with a fourth detection unit and a reagent storage area. The fourth detection unit includes a fourth detection chamber that can communicate with the sample inlet and a test strip disposed in the fourth detection chamber. The reagent storage area includes a reagent storage cavity and a reagent channel connected to the outlet of the reagent storage cavity. The reagent channel is connected to the fourth detection cavity. The reagent channel is provided with a sealing structure that can be broken by fluid pressure. The reagent channel has a blocked state and an unblocked state. When it is in the blocked state, the reagent storage cavity is isolated from the fourth detection cavity. When it is in the unblocked state, the reagent storage cavity is connected to the fourth detection cavity.

[0029] In some embodiments, a sealing layer is provided at the sample inlet to seal the sample inlet, and the consumable further includes a delivery tube assembly disposed outside the main body to guide the sample into the main body. The delivery tube assembly is connected to the sample inlet and includes a blood collection tube. The sealing layer can be punctured when the blood collection tube is inserted into the sample inlet.

[0030] A sealing part is also provided at the sample inlet. The sealing part is located inside the sealing layer and cooperates with the blood collection tube to prevent the sample from flowing out of the main body.

[0031] In some embodiments, a sealing plug is provided at the sample inlet, and the sealing layer and the sealing part are integrally disposed on the sealing plug.

[0032] In some embodiments, the sealing part is a through hole provided on the sealing plug, and the blood collection tube is connected to the through hole by an interference fit.

[0033] In some embodiments, one end face of the sealing layer facing the delivery pipe assembly is a plane, and a thinning portion is provided on the other end face of the sealing layer opposite to the one end face to reduce the thickness of the sealing layer.

[0034] In some embodiments, the sample inlet is provided with one or more.

[0035] Due to the application of the above technical solution, the closed-type chip consumable of this utility model has the following advantages compared with the prior art: The main body of the closed-type chip consumable of this utility model adopts a closed design. After the sample enters the main body, it automatically transfers sequentially to the pre-dilution zone, quantitative zone, mixing zone, and detection unit under the action of fluid pressure, which can realize zero-contact operation, thereby avoiding cross-contamination and operational errors, and shortening the detection time. Moreover, the pre-mixing chamber set on the main body can pre-treat the sample before it enters one or more mixing chambers for further treatment. This can reduce the structural size of each mixing chamber, thereby reducing the structural size of the consumable. Attached Figure Description

[0036] Appendix Figure 1 This is a three-dimensional schematic diagram of the closed-type chip consumable in Embodiment 1.

[0037] Appendix Figure 2 This is an exploded view of the enclosed chip consumable in Embodiment 1.

[0038] Appendix Figure 3 This is a three-dimensional schematic diagram of the base of the enclosed chip consumable in Embodiment 1 after removing part of its structure.

[0039] Appendix Figure 4 This is a top view of the base of the enclosed chip consumable in this embodiment after part of the structure has been removed;

[0040] Appendix Figure 5 For the appendix Figure 4 sectional view along line AA;

[0041] Appendix Figure 6 This is a top view of the base of the enclosed chip consumable in this embodiment after part of the structure has been removed;

[0042] Appendix Figure 7 For the appendix Figure 6 Enlarged view of a portion of point A in the middle;

[0043] Appendix Figure 8 This is a top view of the base of the enclosed chip consumable in this embodiment after part of the structure has been removed;

[0044] Appendix Figure 9 For the appendix Figure 8 sectional view along line AA;

[0045] Appendix Figure 10 For the appendix Figure 8 sectional view along line BB;

[0046] Appendix Figure 11 This is a bottom view of the base in the enclosed chip consumable in this embodiment;

[0047] Appendix Figure 12 This is a schematic diagram of the structure at the sample inlet in the closed-loop chip consumable of this embodiment;

[0048] Appendix Figure 13 For the appendix Figure 12 sectional view along line AA;

[0049] Appendix Figure 14 For the appendix Figure 13 A magnified view of a portion of point A in the middle.

[0050] The components are as follows: 1. Main body; 1a. Base plate; 1b. Lower membrane; 1c. Upper membrane; 1c1. Cover membrane; 1d. Detection chamber cover plate; 1e. Sealing structure; 10. Sample inlet; 111. Quantitative chamber; 112. Sample outlet channel; 113. Exhaust port; 114. Distribution chamber; 115. Overflow chamber; 116. Plug; 121. First mixing chamber; 122. Second mixing chamber; 123. Narrow channel; 124. Mixed fluid channel; 131. First detection chamber; 132. Waste liquid channel; 133. Waste liquid chamber; 134. Buffer chamber; 141. Temporary storage chamber; 142. Second detection chamber; 143. Waste liquid chamber; 15. Third detection chamber; 161. First premixing chamber; 162. Second premixing chamber; 163. Narrow channel; 164. Premixed fluid channel; 17. Fourth detection chamber; 81. Reagent channel; 182. First reagent storage chamber; 183. Second reagent storage chamber; 183. Narrow channel; 19. Sealing plug; 191. Sealing layer; 192. Sealing part;

[0051] 21. Delivery pipe assembly; 211. Body; 212. Sampling pipe; 213. Sealing piston. Detailed Implementation

[0052] The technical solution of this utility model will now be clearly and completely described with reference to the accompanying drawings. Obviously, the described embodiments are only some, not all, of the embodiments of this utility model. Based on the embodiments of this utility model, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of this utility model.

[0053] In the description of this utility model, it should be noted that the terms "center," "upper," "lower," "left," "right," "vertical," "horizontal," "inner," and "outer," etc., indicate the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings. This is only for the convenience of describing this utility model and simplifying the description, and does 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. Therefore, it should not be construed as a limitation on this utility model. In addition, the terms "first," "second," and "third" are used for descriptive purposes only and should not be construed as indicating or implying relative importance.

[0054] like Figure 1 and Figure 2 As shown, the enclosed chip consumable in this embodiment includes a main body 1 and a delivery tube assembly 21.

[0055] The main body 1 is provided with a sample inlet 10, a quantitative zone, a mixing zone and a detection unit. The quantitative zone, the mixing zone and the detection unit are connected in sequence. The sample enters the main body through the sample inlet 10, passes through the quantitative zone and the mixing zone in sequence and then goes to the detection unit for detection.

[0056] The detection unit includes a first detection unit, which can be used for blood cell detection. One or more quantitative zones, mixing zones, and the first detection unit are provided, and each of these zones corresponds to one another.

[0057] like Figures 1-3 As shown, each quantitative zone includes a quantitative cavity 111 connected to the sample inlet 10 and a sample outlet channel 112 connected to the quantitative cavity 111. The sample outlet channel 112 is connected to the mixing zone.

[0058] The metering chamber 111 is configured to guide a set volume of fluid sample to the mixing zone. Specifically, the volume of the metering chamber 111 is fixed. After the fluid enters and fills the metering chamber 111, the volume of the fluid in the metering chamber 111 is fixed. All the fluid in the metering chamber 111 enters the mixing zone for mixing to ensure the volume of fluid entering the mixing zone.

[0059] The metering chamber 111 and the sample outlet channel 112 are connected via an exhaust port 113 formed on the main body 1. A waterproof and breathable membrane is provided at the exhaust port 113. When fluid flows into the metering chamber 111, the gas in the metering chamber 111 can be discharged from the exhaust port 113, thus ensuring that the metering chamber 111 is filled with fluid. The waterproof and breathable membrane provided at the exhaust port 113 is preferably resistant to hydrostatic pressure of 200 kPa or higher and has a permeability of 800 ml / min / cm. 2 A composite PTFE membrane with a pressure resistance of over / kPa is used to prevent fluids with insufficient pressure resistance from leaking directly from the waterproof and breathable membrane.

[0060] like Figure 2 and Figure 3 As shown, the main body 1 is also provided with a distribution cavity 114. The distribution cavity 114 is located between the sample inlet 10 and each quantitative cavity 111. The fluid entering the main body 1 is distributed by the distribution cavity 114 and then enters each quantitative cavity 111, thereby ensuring that the fluid fills each quantitative cavity 111.

[0061] The dispensing cavity 114 is a long and narrow channel, and the cross-sectional area of ​​each metering cavity 111 is larger than the cross-sectional area of ​​the dispensing cavity 114. For example... Figure 2 and Figure 3As shown, the main body also includes an overflow chamber 115 connected to the distribution chamber 114. The distance between the inlet of each metering chamber 111 and the inlet of the distribution chamber 114 is smaller than the distance between the inlet of the overflow chamber 115 and the inlet of the distribution chamber 114. Since the cross-sectional area of ​​the metering chamber 111 is relatively large, the fluid resistance is very small, while the cross-sectional area of ​​the distribution chamber 114 is relatively small, resulting in greater fluid resistance. Therefore, when fluid flows in the distribution chamber 114, if it reaches the inlet of the metering chamber 111, it will preferentially fill the metering chamber 111. According to this principle, after the fluid fills all the metering chambers 111, the excess fluid will flow into the overflow chamber 115. Therefore, when introducing fluid into the distribution chamber 114, a slightly excessive amount of fluid is injected so that the overflow chamber 115 is also filled with a certain volume of fluid, ensuring that the fluid fills each metering chamber 111.

[0062] When multiple quantitative zones are provided, it is preferable that each quantitative cavity 111 and overflow cavity 115 are arranged in parallel, and the extension direction of the distribution cavity 122 is perpendicular to the extension direction of each quantitative cavity 111 and overflow cavity 115. This arrangement can reduce the structural volume of the main body 1.

[0063] Both the metering chamber 111 and the overflow chamber 115 extend to the outside of the main body 1, such as Figure 1 and Figure 2 As shown, the consumable also includes a plug 116, which seals one end of each metering chamber 111 and overflow chamber 115 extending to the outside of the main body. The plug 116 is slidably disposed along the extending direction of each metering chamber 111 and overflow chamber 115. While sealing each metering chamber 111, the plug 116 can also be pushed to slide within the metering chamber 111, squeezing and pushing the fluid in the metering chamber 111, thereby pushing all the fluid in the metering chamber 111 into the mixing zone. The purpose of setting the plug 116 in the overflow chamber 115 is to block the inlet of the overflow chamber 115 when the plug 116 in the metering chamber 111 is pushed to transfer fluid, thereby preventing the fluid in the metering chamber 111 from entering the overflow chamber 115. However, this does not guarantee that all the fluid in the metering chamber 111 is pushed into the mixing zone, and thus cannot achieve quantitative fluid delivery.

[0064] like Figure 2 As shown, the mixing zone includes a mixing chamber and a mixing fluid channel 124 connected to the outlet of the mixing chamber, and a sample outlet channel 112 connected to the inlet of the mixing chamber.

[0065] The mixing fluid channel 124 has a blocked state and an unblocked state. When it is in the blocked state, the mixing chamber is isolated from the first detection unit. When it is in the unblocked state, the mixing chamber and the first detection unit are connected through the mixing fluid channel 124.

[0066] The sample outlet channel 112 has a blocked state and an unblocked state. When it is in the blocked state, the metering chamber 111 and the mixing chamber are isolated. When it is in the unblocked state, the metering chamber 111 and the mixing chamber are connected through the sample outlet channel 112.

[0067] The mixing chamber contains reagents. Before testing, both the mixing fluid channel 124 and the sample outlet channel 112 are sealed, thus encapsulating the reagents within the mixing chamber.

[0068] The mixing chamber can be compressed, and after compression, the contents within it flow and are mixed to form a mixed fluid.

[0069] The mixing chamber has at least one compartment. In this embodiment, such as... Figures 1-6 and Figure 8 As shown, the mixing chamber includes a first mixing chamber 121 and a second mixing chamber 122. The first mixing chamber 121 and the second mixing chamber 122 are connected by a narrow channel 123. The sample outlet channel 112 is connected to the first mixing chamber 121, and the mixing fluid channel 124 is connected to the second mixing chamber 122.

[0070] The narrow channel 123 allows the fluid to increase its velocity at the narrow channel 123 when it flows back and forth between the first mixing chamber 121 and the second mixing chamber 122, thereby increasing the mixing effect.

[0071] Preferably, the depth of the first mixing chamber 121 and the second mixing chamber 122 is no greater than 5 mm, as a larger depth is not conducive to fluid mixing. The bottom and corners of the first mixing chamber 121 and the second mixing chamber 122 are rounded to reduce fluid sample residue in dead corners.

[0072] like Figure 2 and Figure 11 As shown, the first detection unit includes a first detection chamber 131, a waste liquid channel 132, and a waste liquid chamber 133 connected in sequence.

[0073] The first detection cavity 131 is a flat cavity. Specifically, the height of the first detection cavity is 0.1–0.4 mm, and the cross-sectional area of ​​the first detection cavity is 50–70 mm². 2 The volume of the first detection chamber is approximately 10–25 μL. The first detection chamber 131 has an inlet for fluid to flow in and an outlet for fluid to flow out. Both the inlet and the outlet are located at the bottom of the first detection chamber 131, and the distance between the inlet and the outlet is the greatest at the bottom of the first detection chamber 131.

[0074] The first detection chamber 131, the waste liquid channel 132, and the waste liquid chamber 133 are sequentially connected. When fluid enters the first detection chamber 131, it quickly fills the first detection chamber 131. When the fluid in the first detection chamber 131 is not driven or is driven but the driving force is less than a set value, the fluid will not automatically exit from the first detection chamber 131. When the fluid in the first detection chamber 131 is driven or is driven with a driving force greater than or equal to the set value, the fluid exits from the first detection chamber 131 and enters the waste liquid chamber 133 through the waste liquid channel 132.

[0075] like Figures 2-4 , Figure 6 and Figure 8 As shown, the first detection unit further includes a buffer chamber 134 disposed between the mixing fluid channel 124 and the first detection chamber 131. The buffer chamber 134 is connected to both the mixing fluid channel 124 and the first detection chamber 131, and the flow direction of the fluid in the buffer chamber 134 is perpendicular to the flow direction of the fluid in the mixing fluid channel 124. This arrangement can slow down the flow rate of the fluid entering the first detection chamber 131, while allowing some air bubbles in the fluid to remain in the buffer chamber 134 instead of flowing into the first detection chamber 131, thereby improving the detection effect.

[0076] The detection unit may also include a second detection unit, which can be used for immune detection, such as for the detection of SAA, CRP, etc.

[0077] like Figure 8 and Figure 9 As shown, the second detection unit includes a temporary storage chamber 141, a second detection chamber 142, and a waste liquid chamber 143. A test strip is disposed in the second detection chamber 142. The temporary storage chamber 141 is connected to the second detection chamber 142 and the waste liquid chamber 143 respectively. The quantitative chamber 111, the sample outlet channel 112, the mixing chamber, the mixing fluid channel 124, and the temporary storage chamber 141 are connected in a corresponding manner.

[0078] The temporary storage chamber 141 is a cylindrical cavity with a fixed volume. There is a small hole at the bottom that connects to the second detection chamber 142. After the fluid fills the temporary storage chamber 141, the fluid flows directly through the small hole at the bottom of the temporary storage chamber 141 to the top of the test strip and is absorbed.

[0079] The waste liquid chamber 143 of the second detection unit can be shared with the waste liquid chamber 133 of the first detection unit, or they can be set up independently.

[0080] The detection unit may also include a third detection unit, which can be used for hemoglobin detection.

[0081] like Figures 3-5 As shown, the third detection unit includes a third detection chamber 15 for absorbance detection, and a quantitative chamber 111, a sample outlet channel 112, a mixing chamber, a mixing fluid channel 124 and the third detection chamber 15 are connected in a one-to-one correspondence.

[0082] In this embodiment, the chip consumable also includes a pre-dilution region for pre-dilution of the sample, which is formed within the main body 1.

[0083] like Figure 2 As shown, the pre-dilution zone includes a premixing chamber disposed within the main body 1 and a premixed fluid channel 164 connected to the outlet of the premixing chamber. The premixing chamber is connected to the sample inlet 10, and the premixed fluid channel 164 is connected to the inlet of the dispensing chamber 114.

[0084] The premixed fluid channel 164 has a blocked state and an unblocked state. When it is in the blocked state, the distribution chamber 114 is isolated from the premixing chamber. When it is in the unblocked state, the distribution chamber 114 and the premixing chamber are connected through the premixed fluid channel 164.

[0085] The premixing chamber stores reagents. Before detection, the premixed fluid channel 164 is blocked and the sample inlet 10 is sealed, thus encapsulating the reagents within the premixing chamber.

[0086] The premixing chamber can be compressed, and after compression, the contents within the premixing chamber flow and are mixed to form a mixed fluid.

[0087] The premixing chamber has at least one compartment. In this embodiment, such as... Figures 1-4 , Figure 6 and Figure 8 As shown, the premixing chamber includes a first premixing chamber 161 and a second premixing chamber 162. The first premixing chamber 161 and the second premixing chamber 162 are connected by a narrow channel 163. The sample inlet 10 is connected to the first premixing chamber 161, and the premixed fluid channel 164 is connected to the second premixing chamber 162.

[0088] The narrow channel 163 allows the fluid to increase its velocity at the narrow channel 163 when it flows back and forth between the first premixing chamber 161 and the second premixing chamber 162, thereby increasing the mixing effect.

[0089] Preferably, the depth of the first premixing chamber 161 and the second premixing chamber 162 is no more than 5 mm, as a larger depth is not conducive to the mixing of fluids.

[0090] The main body 1 also includes a fourth detection unit and a reagent storage area. The fourth detection unit can be used for immunoassays, such as PCT testing. Figures 2-4 , Figure 6 , Figure 8 and Figure 10 As shown, the fourth detection unit includes a fourth detection chamber 17 and a test strip disposed within the fourth detection chamber 17. During PCT testing, no sample dilution is required; therefore, the fourth detection chamber 17 is directly connected to the sample inlet 10.

[0091] The reagent storage area includes a reagent storage cavity and a reagent channel 181 connected to the outlet of the reagent storage cavity. The reagent channel 181 is connected to the fourth detection cavity 17.

[0092] The reagent storage chamber contains reagents. The reagent storage chamber can be pressed, and after being pressed, the reagents stored inside flow out of the reagent storage chamber.

[0093] The reagent channel 181 has a blocked state and an unblocked state. When it is in the blocked state, the reagent storage chamber and the fourth detection chamber are isolated. When it is in the unblocked state, the reagent storage chamber and the fourth detection chamber 17 are connected through the reagent channel 181.

[0094] For ease of operation, the reagent storage chamber has the same structural form as the mixing chamber and the premixing chamber. Specifically, the reagent storage chamber includes a first reagent storage chamber 182 and a second reagent storage chamber 183. The first reagent storage chamber 182 and the second reagent storage chamber 183 are connected by a narrow channel 184, and a reagent channel 181 is connected to the second reagent storage chamber 183. Figures 2-4 , Figure 6 and Figure 8 As shown.

[0095] When a fourth detection unit is provided, one or more sample inlets 10 are provided. In this embodiment, two sample inlets 10 are provided, one sample inlet 10 is connected to the premixing chamber, and the other sample inlet 10 is connected to the fourth detection chamber 17.

[0096] The delivery tube assembly 21 is used for sample collection, and it is connected to each sample inlet 10. For example... Figure 2 As shown, the delivery tube assembly 21 includes a body 211 and a sampling tube 212 disposed at one end of the body 211. The sampling tube 212 is used to collect samples. A first channel is provided inside the sampling tube 212. After hydrophilic treatment, the sampling tube 212 can easily draw in samples through capillary action and fill the first channel to ensure volume. A second channel is provided inside the body 211, and the first channel and the second channel are connected. A sealing piston 213 is provided at the end of the second channel away from the first channel to block the first channel. The sealing piston 213 is slidably disposed in the second channel. By pushing the sealing piston 213 to slide in the second channel, the sample collected by the sampling tube 212 can be pushed from the sample inlet 10 into the premixing chamber and the fourth detection chamber 17.

[0097] like Figures 12-14As shown, each sample inlet 10 is equipped with a sealing layer 191, which seals the sample inlet 10 when no test is being performed. When the delivery tube assembly 21 is connected to the sample inlet 10, the sampling tube 212 is inserted into the sample inlet 10, and the sampling tube 212 can pierce the sealing layer 191 and extend into the interior of the sample inlet 10.

[0098] The sealing layer 191 has a flat end face facing the conveying pipe assembly 21, and a thinning portion is provided on the other end face of the sealing layer 191 opposite to the one end face to reduce the thickness of the sealing layer 191.

[0099] Each sample inlet 10 is equipped with a sealing part 192. The sealing part 192 cooperates with the sampling tube 212 after the sampling tube 212 passes through the sealing layer 191 to prevent the sample from flowing out from the damaged part of the sealing layer 191.

[0100] In this embodiment, a sealing plug 19 is provided at each sample inlet 10. The sealing layer 191 and the sealing part 192 are integrally disposed on the sealing plug 19. The sealing part 192 is a through hole provided on the sealing plug 19, and the sampling tube 212 is interference-fitted with the through hole. This simplifies the processing technology and assembly.

[0101] In this embodiment, such as Figure 2 As shown, the main body includes a base plate 1a, a lower film 1b bonded to the base plate 1a, and an upper film 1c bonded to the lower film 1b. The base plate 1a is made of common transparent plastic materials, such as PMMA, COC, and PC. The lower film 1b is a thin film structure, and uses a material with certain thermal adhesion, preferably EVA, PET, PE, TPE, etc., and is bonded to the upper surface of the base plate 1a by adhesives or similar bonding agents. The upper film 1c also uses a material with certain thermoplastic properties, such as PE, PP, and PVC, and the lower film 1b and the upper film 1c are bonded together by ultrasonic welding, high-frequency welding, or high-temperature hot-melt welding.

[0102] The sample inlet 10, quantitative chamber 111, distribution chamber 114, overflow chamber 115, first detection chamber 131, waste liquid channel 132, waste liquid chamber 133, buffer chamber 134, temporary storage chamber 141, second detection chamber 142, waste liquid chamber 143, third detection chamber 15, and fourth detection chamber 17 are all located within the base plate 1a.

[0103] The base plate 1a covers the detection cover plate 1d at the positions corresponding to each of the first detection cavities 131. The detection cover plate 1d and the base plate 1a can be bonded by different methods, such as ultrasonic welding, laser welding, double-sided pressure-sensitive adhesive bonding, etc. The detection cavity cover plate 1d is preferably made of a transparent polymer with high light transmittance, such as PMMA, PC, etc.

[0104] The mixing chamber, premixing chamber, and reagent storage chamber each include a cavity set on the base plate 1a and a cover membrane set on the upper membrane 1c and located directly above the cavity. The lower membrane 1b has an opening corresponding to the position of the cavity. The cover membrane has an upwardly convex arc structure and is used for pressing to allow fluid to flow in the cavity. The upward convexity of the cover membrane is to allow the upper membrane 1c to deform in advance, preventing excessive deformation and breakage during the pressing process.

[0105] like Figure 7 As shown, the sample outlet channel 112, the mixing fluid channel 124, the premixed fluid channel 164, and the reagent channel 181 are all at least partially formed between the upper membrane 1c and the lower membrane 1b. Specifically, the upper membrane 1c and the lower membrane 1b are bonded together except at the locations of the sample outlet channel 112, the mixing fluid channel 124, the premixed fluid channel 164, and the reagent channel 181. The upper membrane 1c and the lower membrane 1b located at the locations of the sample outlet channel 112, the mixing fluid channel 124, the premixed fluid channel 164, and the reagent channel 181 are partially bonded together, and the bonded portions form sealing structures 1e, the length and width of which are approximately 0.5-2 mm.

[0106] The bond strength between the upper membrane 1c and the lower membrane 1b at sealing structure 1e is less than the bond strength between the upper membrane 1c and the lower membrane 1b at other locations besides sealing structure 1e. Therefore, sealing structure 1e can be destroyed by the fluid pressure in the channel. When sealing structure 1e is intact, the channel is in a blocked state. When sealing structure 1e is destroyed, the channel is in a non-blocked state.

[0107] By adjusting the welding parameters and area between the upper film 1c and the lower film 1b, areas with different bonding strengths can be created. For example, ultrasonic welding uses ultrasonic waves of different powers, while hot melt welding adjusts the temperature of the welding head and the contact time. Taking hot melt bonding of EVA film as an example, a welding temperature of 80-90℃ and a welding time of 5-10 seconds can be used at the sealing structure 1e. For other bonding areas between the upper film 1c and the lower film 1b, excluding the sealing structure 1e, a welding temperature of 100-120℃ and a welding time of 20-40 seconds can be used.

[0108] In this embodiment, the main body 1 has four sets of corresponding quantitative areas, mixing areas, and first detection units, which respectively detect red blood cell count, white blood cell count, five-part differential count, and platelet count. A set of corresponding quantitative areas, mixing areas, and second detection units is provided for simultaneous CRP and SAA immune detection. A set of corresponding quantitative areas, mixing areas, and third detection units is provided for hemoglobin detection. A set of fourth detection units is provided for PCT detection.

[0109] The above embodiments are only for illustrating the technical concept and features of this utility model, and are intended to enable those skilled in the art to understand the content of this utility model and implement it accordingly. They should not be construed as limiting the scope of protection of this utility model. All equivalent changes or modifications made in accordance with the spirit and essence of this utility model should be included within the scope of protection of this utility model.

Claims

1. A closed-type chip consumable, comprising a main body, characterized in that: The main body is provided with a sample inlet, a pre-dilution zone, a quantification zone, a mixing zone, and a detection unit. The pre-dilution zone includes a pre-mixing chamber and a pre-mixing fluid channel connected to the outlet of the pre-mixing chamber. The mixing zone includes a mixing chamber and a mixing fluid channel connected to the outlet of the mixing chamber. The sample inlet, the premixing chamber, the premixing fluid channel, the quantitative zone, the mixing chamber, the mixing fluid channel, and the detection unit are connected in sequence. The premixing chamber and the mixing chamber respectively store reagents. The premixing chamber can be pressed, and after pressing, the contents therein are mixed to form a premixed fluid. The mixing chamber can be pressed, and after pressing, the contents therein are mixed to form a mixed fluid.

2. The closed-type chip consumable according to claim 1, characterized in that: The premixed fluid channel has a blocked state and an unblocked state. When it is in the blocked state, the premixing chamber and the metering zone are isolated. When it is in the unblocked state, the premixing chamber and the metering zone are connected. And / or, the mixing fluid channel has a blocked state and a non-blocked state. When it is in the blocked state, the mixing chamber is isolated from the detection unit. When it is in the non-blocked state, the mixing chamber is connected to the detection unit.

3. The closed-loop chip consumable according to claim 1, characterized in that: The quantitative zone includes a quantitative cavity and a sample outlet channel communicating with the quantitative cavity. The quantitative cavity is connected to the premixed fluid channel, and the sample outlet channel is connected to the mixing cavity. The sample outlet channel has a blocked state and an unblocked state. When it is in the blocked state, the mixing chamber and the quantitative chamber are disconnected. When it is in the unblocked state, the mixing chamber and the quantitative chamber are connected.

4. The closed-loop chip consumable according to claim 3, characterized in that: The quantitative zone, the mixing zone, and the detection unit are provided in multiple sets, and the pre-dilution zone is connected to each of the multiple sets of quantitative zones.

5. The closed-type chip consumable according to claim 4, characterized in that: The main body is also provided with a distribution chamber, which is located between the premixing chamber and each of the metering chambers. The fluid flowing out of the premixing chamber is distributed by the distribution chamber and then enters each of the metering chambers.

6. The closed-loop chip consumable according to claim 5, characterized in that: The cross-sectional area of ​​the metering cavity is larger than that of the dispensing cavity. The main body is also provided with an overflow cavity that communicates with the dispensing cavity. The distance between the inlet of each metering cavity and the inlet of the dispensing cavity is smaller than the distance between the inlet of the overflow cavity and the inlet of the dispensing cavity.

7. The closed-loop chip consumable according to claim 6, characterized in that: One end of each of the metering chamber and the overflow chamber extends to the outside of the main body, and each of the metering chamber and the overflow chamber is slidably provided with a plug for sealing.

8. The closed-loop chip consumable according to claim 3, characterized in that: The quantitative chamber and the sample outlet channel are connected through an exhaust port formed on the main body, and a waterproof and breathable membrane is provided at the exhaust port.

9. The closed-loop chip consumable according to claim 3, characterized in that: The premixed fluid channel, the sample outlet channel, and the mixed fluid channel are each provided with a sealing structure that can be broken by fluid pressure. The main body includes a base plate, a lower membrane bonded to the base plate, and an upper membrane bonded to the lower membrane. The premixed fluid channel, the sample outlet channel, and the mixed fluid channel are all at least partially formed between the upper membrane and the lower membrane. The upper membrane and the lower membrane located at the premixed fluid channel, the sample outlet channel, and the mixed fluid channel are partially bonded together to form the sealing structure.

10. The closed-loop chip consumable according to claim 1, characterized in that: The premixing chamber includes a first premixing chamber and a second premixing chamber, which are connected by a narrow channel. The premixed fluid channel is connected to the second premixing chamber, and the sample inlet is connected to the first premixing chamber. The mixing chamber includes a first mixing chamber and a second mixing chamber, which are connected by a narrow channel. The mixing fluid channel is connected to the second mixing chamber, and the metering zone is connected to the first mixing chamber.

11. The closed-loop chip consumable according to claim 1, characterized in that: The detection unit includes a first detection unit, which includes a first detection chamber, a waste liquid passage, and a waste liquid chamber connected in sequence. The first detection chamber is connected to the mixed fluid passage in a one-to-one correspondence.

12. The enclosed chip consumable according to claim 11, characterized in that: The first detection cavity is a flat cavity; and / or, the height of the first detection cavity is 0.1–0.4 mm; and / or, the cross-sectional area of ​​the first detection cavity is 50–70 mm². 2 ; and / or, the volume of the first detection chamber is 10 to 25 μL.

13. The enclosed chip consumable according to claim 11, characterized in that: The first detection chamber has an inlet for the fluid sample to flow in and an outlet for the fluid sample to flow out. Both the inlet and outlet of the first detection chamber are located at the bottom of the first detection chamber, and the distance between the inlet and outlet of the first detection chamber is the farthest at the bottom of the first detection chamber.

14. The enclosed chip consumable according to claim 11, characterized in that: The first detection unit further includes a buffer cavity disposed between the mixed fluid channel and the first detection cavity. The buffer cavity is connected to both the mixed fluid channel and the first detection cavity. The flow direction of the fluid in the buffer cavity is perpendicular to the flow direction of the fluid in the mixed fluid channel.

15. The closed-loop chip consumable according to claim 1, characterized in that: The detection unit further includes a second detection unit, which includes a temporary storage chamber, a second detection chamber, and a waste liquid chamber. A test strip is disposed in the second detection chamber. The temporary storage chamber is connected to the second detection chamber and the waste liquid chamber respectively. The temporary storage chamber and the mixed fluid channel are connected in a one-to-one correspondence.

16. The closed-loop chip consumable according to claim 1, characterized in that: The detection unit further includes a third detection unit, which includes a third detection chamber for absorbance detection, and the third detection chamber is connected to the mixing fluid channel in a one-to-one correspondence.

17. The closed-loop chip consumable according to claim 1, characterized in that: The main body is further provided with a fourth detection unit and a reagent storage area. The fourth detection unit includes a fourth detection chamber that can communicate with the sample inlet and a test strip disposed in the fourth detection chamber. The reagent storage area includes a reagent storage cavity and a reagent channel connected to the outlet of the reagent storage cavity. The reagent channel is connected to the fourth detection cavity. The reagent channel is provided with a sealing structure that can be broken by fluid pressure. The reagent channel has a blocked state and an unblocked state. When it is in the blocked state, the reagent storage cavity and the fourth detection cavity are isolated. When it is in the unblocked state, the reagent storage cavity and the fourth detection cavity are connected.

18. The closed-loop chip consumable according to claim 1, characterized in that: The sample inlet is provided with a sealing layer to seal the sample inlet. The consumable also includes a delivery tube assembly disposed outside the main body to guide the sample into the main body. The delivery tube assembly is connected to the sample inlet. The delivery tube assembly includes a blood collection tube. The sealing layer can be punctured when the blood collection tube is inserted into the sample inlet. A sealing part is also provided at the sample inlet. The sealing part is located inside the sealing layer and cooperates with the blood collection tube to prevent the sample from flowing out of the main body.

19. The closed-loop chip consumable according to claim 18, characterized in that: A sealing plug is provided at the sample inlet, and the sealing layer and the sealing part are integrally disposed on the sealing plug.

20. The closed-loop chip consumable according to claim 19, characterized in that: The sealing part is a through hole provided on the sealing plug, and the blood collection tube is connected to the through hole by an interference fit.

21. The closed-loop chip consumable according to claim 18, characterized in that: The sealing layer has a flat end face facing the conveying pipe assembly, and a thinning portion is provided on the other end face of the sealing layer opposite to the one end face to reduce the thickness of the sealing layer.

22. The closed-loop chip consumable according to claim 1, characterized in that: The sample inlet is provided with one or more.

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