Plasma separation device suitable for immunoassay

Abstract

The invention relates to a plasma separation device suitable for immunoassay, and relates to the field of medical instruments. Comprising a separation structure, separation consumables and a cell plasma collection structure, the separation consumable is mounted on the separation structure and is used for providing blood to be separated for plasma separation; the separation structure is used for separating to-be-separated blood into blood cells and plasma; and the cell plasma collecting structure is used for respectively collecting the separated blood cells and plasma. The passive separation of plasma is realized by using the gravity of whole blood and the negative magnetic separation effect, and the separation is rapid.

Description

Technical Field

[0001] This invention relates to the field of medical devices, specifically to a plasma separation device suitable for immunoassay. Background Technology

[0002] In current clinical trials—typical biochemical and immunological analyses—blood cells interfere with potential detections, objectively necessitating plasma separation from whole blood; the most widely used method is centrifugation. One problem with centrifugation is its long processing time, typically requiring 10 minutes; it is also unsuitable for small blood volumes.

[0003] To address the shortcomings of centrifugation in terms of response time and blood volume, several alternative solutions exist, broadly categorized as active and passive separation technologies. Active separation technology utilizes acoustic, electric, and magnetic fields in conjunction with precision pump and valve control, resulting in complex and costly equipment, and limiting its application to specific scenarios, such as fieldwork. One passive separation method is membrane filtration integrating capillary effects, which is relatively simple but suffers from clogging and low processing efficiency. Another passive separation method utilizes microfluidic technology, based on fluid dynamics principles such as inertia and lateral flow; however, its fluid channels require specialized design, limiting its applicability.

[0004] Therefore, how to provide a plasma separation device suitable for immunoassay has become a technical problem for those skilled in the art. Summary of the Invention

[0005] To address at least one technical problem in the background art, the present invention provides a plasma separation device suitable for immunoassay, which utilizes the gravity and negative magnetic field effect of whole blood to achieve passive separation of plasma, and the separation is rapid.

[0006] To achieve the above objectives, the present invention provides a plasma separation device suitable for immunoassay, comprising: a separation structure, separation consumables, and a cell plasma collection structure; The separation consumables are installed on the separation structure and are used to provide blood to be separated for plasma separation; The separation structure is used to separate the blood to be separated into blood cells and plasma; The cell plasma collection structure collects the separated blood cells and plasma respectively.

[0007] Furthermore, the separation consumable includes a whole blood loading chamber, a separation channel, a plasma collection channel, a blood cell collection channel, and a consumable positioning structure; the whole blood loading chamber is connected to the top of the separation channel, the plasma collection channel and the blood cell collection channel are respectively connected to both sides of the separation channel, and the consumable positioning structure is installed on the outer wall of the separation channel.

[0008] Furthermore, the separation structure includes a magnetic circuit assembly, a valve actuation assembly, a control module, and a housing; the magnetic circuit assembly, the valve actuation assembly, and the control module are all disposed within the housing; the magnetic circuit assembly is installed outside the separation channel and is used to separate the blood to be separated into blood cells and plasma; the valve actuation assembly is located below the magnetic circuit assembly and is used to open and close the flow of blood cells and plasma; the magnetic circuit assembly and the valve actuation assembly are respectively electrically connected to the control module.

[0009] Furthermore, the magnetic circuit assembly includes a fixed housing, and magnet one and magnet two are symmetrically installed on both sides inside the fixed housing.

[0010] Furthermore, the valve actuation assembly includes a support plate, a drive motor, a return spring, an opening arm, an opening arm rotation shaft, a drive cam, and a clamping valve. The support plate is mounted on the side wall of the housing, and the drive motor is mounted on the bottom end of the support plate. Its output shaft passes through the support plate and is connected to the drive cam. There are two opening arms, one end of which is connected by a return spring, and the other end of each arm is hinged to the opening arm rotation shaft mounted on the support plate. The ends of the two opening arms near the opening arm rotation shaft are respectively connected to the two feet of the clamping valve for driving the clamping valve to open and close. The drive cam is located between the two opening arms.

[0011] Furthermore, the valve actuation assembly also includes a spreading arm limiting pin, which is mounted on the support plate and located between the spreading arm rotation shaft and the drive cam.

[0012] Furthermore, a groove is provided on the bottom wall inside the outer shell, and the cell plasma collection structure is slidably disposed in the groove.

[0013] Furthermore, the cell plasma collection structure includes a cell plasma collection tube holder, a blood cell collection tube, and a plasma collection tube; the cell plasma collection tube holder is equipped with the blood cell collection tube and the plasma collection tube.

[0014] Furthermore, the separation consumables are available in various sizes, including 200μL, 600μL, 1000μL, 2000μL and 3000μL consumables.

[0015] The beneficial effects of this invention are as follows: This invention provides a set of whole blood separation container consumables and separation device adapted to different blood volumes, which utilize the gravity and negative magnetic field effect of whole blood to achieve passive separation of plasma, and the whole blood separation is rapid. Attached Figure Description

[0016] Figure 1 This is an exploded view of the present invention; Figure 2This is a schematic diagram of the separation structure of the present invention; Figure 3 This is a schematic diagram of the structure of the consumable material of the present invention; Figure 4 This is a schematic diagram of the magnetic circuit assembly of the present invention; Figure 5 This is a schematic diagram of the installation structure of magnet one and magnet two of the present invention; Figure 6 This is a schematic diagram of the valve actuation assembly of the present invention; Figure 7 This is a schematic diagram of the cell plasma collection structure of the present invention.

[0017] In the diagram: 1-Separation structure, 2-Separation consumables, 3-Cell plasma collection structure, 11-Magnetic circuit assembly, 12-Valve action assembly, 13-Control module, 14-Shell, 21-Whole blood loading chamber, 22-Separation channel, 23-Plasma collection channel, 24-Blood cell collection channel, 25-Consumable positioning structure, 111-Fixed shell, 112-Magnet 1, 113-Magnet 2, 121-Support plate, 122-Drive motor, 123-Reset spring, 124-Opening arm, 125-Opening arm rotation shaft, 126-Drive cam, 127-Clamping valve, 128-Opening arm limit pin, 141-Slide groove, 31-Cell plasma collection test tube holder, 32-Blood cell collection test tube, 33-Plasma collection test tube. Detailed Implementation

[0018] The technical solutions in the embodiments of the present invention will be clearly and completely described below. 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.

[0019] It should be noted that the terms "first," "second," etc., in the specification, claims, and accompanying drawings of this application are used to distinguish similar objects and are not necessarily used to describe a specific order or sequence. It should be understood that such data can be interchanged where appropriate for the embodiments of this application described herein. Furthermore, the terms "comprising" and "having," and any variations thereof, are intended to cover non-exclusive inclusion; for example, a process, method, system, product, or apparatus that comprises a series of steps or units is not necessarily limited to those steps or units explicitly listed, but may include other steps or units not explicitly listed or inherent to such processes, methods, products, or apparatus.

[0020] In this application, the terms "upper," "lower," "left," "right," "front," "rear," "top," "bottom," "inner," "outer," "middle," "vertical," "horizontal," "lateral," and "longitudinal" indicate the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings. These terms are primarily for the purpose of better describing this application and its embodiments, and are not intended to limit the indicated device, element, or component to having a specific orientation, or to be constructed and operated in a specific orientation.

[0021] Furthermore, in addition to indicating location or positional relationship, some of the aforementioned terms may also have other meanings. For example, the term "above" may also be used in some cases to indicate a certain dependency or connection relationship. Those skilled in the art can understand the specific meaning of these terms in this application based on the specific circumstances.

[0022] Furthermore, the terms "installation," "setup," "equipped with," "connection," "linking," and "socketing" should be interpreted broadly. For example, they can refer to a fixed connection, a detachable connection, or an integral structure; 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, or an internal connection between two devices, components, or parts. Those skilled in the art can understand the specific meaning of these terms in this application based on the specific circumstances.

[0023] like Figure 1 and Figure 2 As shown, this embodiment provides a plasma separation device suitable for immunoassay, including: a separation structure 1, a separation consumable 2, and a cell plasma collection structure 3; The separation consumable 2 is installed on the separation structure 1 and is used to provide blood to be separated for plasma separation; The separation structure 1 is used to separate the blood to be separated into blood cells and plasma. The cell plasma collection structure 3 collects the separated blood cells and plasma respectively.

[0024] refer to Figure 3 The separation consumable 2 includes a whole blood loading chamber 21, a separation channel 22, a plasma collection channel 23, a blood cell collection channel 24, and a consumable positioning structure 25. The whole blood loading chamber 21 is connected to the top of the separation channel 22, the plasma collection channel 23 and the blood cell collection channel 24 are respectively connected to the two sides of the separation channel 22, and the consumable positioning structure 25 is installed on the outer wall of the separation channel to facilitate the fixed installation of the separation consumable and the separation structure 1.

[0025] To further optimize the technical solution, the separation consumable 2 is available in various sizes, including 200μL, 600μL, 1000μL, 2000μL, and 3000μL consumables. The height and width of the collection channel are identical for each capacity, but the thickness and the size of the collection channel opening (exhaust hole) differ depending on the capacity. The design of the collection hole is related to the final plasma to blood cell volume ratio, as detailed in Table 1.

[0026]

[0027] Table 1

[0028] refer to Figure 2 The separation structure 1 includes a magnetic circuit assembly 11, a valve actuation assembly 12, a control module 13, and a housing 14. The magnetic circuit assembly 11, the valve actuation assembly 12, and the control module 13 are all disposed within the housing 14. The magnetic circuit assembly 11 is installed outside the separation channel 22 and is used to separate the blood to be separated into blood cells and plasma. The valve actuation assembly 12 is located below the magnetic circuit assembly 11 and is used to open and close the flow of blood cells and plasma. The magnetic circuit assembly 11 and the valve actuation assembly 12 are electrically connected to the control module 13.

[0029] refer to Figure 4 and Figure 5 The magnetic circuit assembly 11 includes a fixed housing 111, and magnet 112 and magnet 113 are symmetrically installed on both sides inside the fixed housing 111. Figure 5 The arrows shown indicate the direction of the magnetic field of the magnet. This design can create a strong magnetic field near the magnet, thereby producing a negative magnetophoretic effect on whole blood mixed with ferrofluid, causing cells to concentrate towards the center of the channel, while the plasma moves to the sides (magnet one and magnet two).

[0030] refer to Figure 6The valve actuation assembly 12 includes a support plate 121, a drive motor 122, a return spring 123, an opening arm 124, an opening arm rotation shaft 125, a drive cam 126, and a clamping valve 127. The support plate 121 is mounted on the side wall of the housing 14. The drive motor 122 is mounted on the bottom end of the support plate 121, and its output shaft passes through the support plate 121 and is connected to the drive cam 126. There are two opening arms 124. One end of each opening arm 124 is connected by a return spring 123, and the other end is hinged to the opening arm rotation shaft 125 mounted on the support plate 121. The ends of the two opening arms 124 near the opening arm rotation shaft 125 are respectively connected to the two feet of the clamping valve 127 for driving the clamping valve 127 to open and close. The drive cam 126 is located between the two opening arms 124. The valve actuation assembly 12 also includes a spreading arm limiting pin 128, which is mounted on the support plate 121 and located between the spreading arm rotation shaft 125 and the drive cam 126. Both the plasma collection channel 24 and the blood cell collection channel 25 are flexible tubes, combined with a flexible clamping valve 127, which can be opened and closed under the action of the valve actuation assembly 12.

[0031] To further optimize the technical solution, a groove 141 is provided on the bottom wall inside the outer shell 14, and the cell plasma collection structure 3 is slidably disposed in the groove 141, thereby facilitating the installation and disassembly of the cell plasma collection structure 3.

[0032] refer to Figure 7 The cell plasma collection structure 3 includes a cell plasma collection tube holder 31, a blood cell collection tube 32, and a plasma collection tube 33; the cell plasma collection tube holder 31 is equipped with a blood cell collection tube 32 and a plasma collection tube 33 for collecting blood cells and plasma respectively.

[0033] This invention provides a set of whole blood separation containers, consumables, and separation devices adapted to different blood volumes. It utilizes the gravity and negative magnetization effect of whole blood to achieve passive plasma separation, and the whole blood separation is rapid. Plasma separation is achieved within 1 minute through a magnetized channel; ultimately, 70% plasma can be extracted, and 100% of blood cells larger than 1µm are separated, meeting clinical trial requirements.

[0034] The working principle of this invention is as follows: The operator loads the separation consumables provided by this invention into the separation structure, and then adds whole blood mixed with ferromagnetic fluid into the whole blood loading chamber of the consumables. Under the action of gravity, the whole blood (mixed with ferromagnetic fluid) flows into the separation channel of the consumables. The whole blood stays in the separation channel for 60 seconds and is separated by the magnetic circuit assembly. The separation structure activates the valve actuation assembly, opening the cell collection channel and the plasma collection channel for 30 seconds, allowing blood cells and plasma to flow into the blood cell collection tube and the plasma collection tube. The stop valve actuation assembly releases the clamping valves of the plasma collection channel and the blood cell collection channel, closing the channels to prevent leakage and contamination.

[0035] The above description is merely a preferred embodiment of the present invention and does not constitute any limitation on the technical scope of the present invention. Therefore, any minor modifications, equivalent changes, and alterations made to the above embodiments based on the technical essence of the present invention shall still fall within the scope of the technical solution of the present invention.

Claims

1. A plasma separation device suitable for immunoassay, characterized in that, include: Separation structure, separation consumables, and cell plasma collection structure; The separation consumables are installed on the separation structure and are used to provide blood to be separated for plasma separation; The separation structure is used to separate the blood to be separated into blood cells and plasma; The cell plasma collection structure collects the separated blood cells and plasma respectively.

2. The plasma separation device suitable for immunoassay as described in claim 1, characterized in that, The separation consumable includes a whole blood loading chamber, a separation channel, a plasma collection channel, a blood cell collection channel, and a consumable positioning structure; the whole blood loading chamber is connected to the top of the separation channel, the plasma collection channel and the blood cell collection channel are respectively connected to the two sides of the separation channel, and the consumable positioning structure is installed on the outer wall of the separation channel.

3. A plasma separation device suitable for immunoassay as described in claim 1 or 2, characterized in that, The separation structure includes a magnetic circuit assembly, a valve actuation assembly, a control module, and a housing; the magnetic circuit assembly, valve actuation assembly, and control module are all disposed within the housing; the magnetic circuit assembly is installed outside the separation channel and is used to separate the blood to be separated into blood cells and plasma; the valve actuation assembly is located below the magnetic circuit assembly and is used to open and close the flow of blood cells and plasma; the magnetic circuit assembly and the valve actuation assembly are electrically connected to the control module respectively.

4. A plasma separation device suitable for immunoassay as described in claim 3, characterized in that, The magnetic circuit assembly includes a fixed housing, and magnet one and magnet two are symmetrically installed on both sides inside the fixed housing.

5. A plasma separation device suitable for immunoassay as described in claim 4, characterized in that, The valve actuation assembly includes a support plate, a drive motor, a return spring, an opening arm, an opening arm rotation shaft, a drive cam, and a clamping valve. The support plate is mounted on the side wall of the housing, and the drive motor is mounted on the bottom end of the support plate. Its output shaft passes through the support plate and is connected to the drive cam. There are two opening arms. One end of each opening arm is connected by a return spring, and the other end is hinged to the opening arm rotation shaft mounted on the support plate. The ends of the two opening arms near the opening arm rotation shaft are respectively connected to the two feet of the clamping valve for driving the clamping valve to open and close. The drive cam is located between the two opening arms.

6. A plasma separation device suitable for immunoassay as described in claim 5, characterized in that, The valve actuation assembly also includes a spreading arm limit pin, which is mounted on the support plate and located between the spreading arm rotation shaft and the drive cam.

7. A plasma separation device suitable for immunoassay as described in claim 6, characterized in that, A groove is provided on the bottom wall inside the outer shell, and the cell plasma collection structure is slidably disposed in the groove.

8. A plasma separation device suitable for immunoassay as described in claim 1 or 7, characterized in that, The cell plasma collection structure includes a cell plasma collection tube holder, a blood cell collection tube, and a plasma collection tube; the cell plasma collection tube holder is equipped with the blood cell collection tube and the plasma collection tube.

9. A plasma separation device suitable for immunoassay as described in claim 1 or 2, characterized in that, The separation consumables are available in various sizes, including 200μL, 600μL, 1000μL, 2000μL and 3000μL consumables.

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