Platelet aggregation function detection reagent card
By designing a platelet aggregation function test kit, which automatically separates plasma using fillers with different pore sizes, the problem of cumbersome operation in existing technologies is solved, and efficient platelet aggregation function detection is achieved.
Patent Information
- Authority / Receiving Office
- CN · China
- Patent Type
- Utility models(China)
- Current Assignee / Owner
- Filing Date
- 2024-12-31
- Publication Date
- 2026-03-24
AI Technical Summary
The separation process for platelet aggregation function detection in existing technologies is cumbersome, resulting in low detection efficiency.
A platelet aggregation function test kit is designed, comprising a shell, a sample compartment, a separation area, an anemic platelet-containing chamber and a rich platelet-containing chamber. It utilizes packing materials with different pore sizes to achieve automatic plasma separation and simplify the operation process.
Eliminating the need for centrifugation and multiple reaction vessels simplifies the operation process, improves separation and detection efficiency, and enhances the accuracy and efficiency of detection.
Smart Images
Figure CN224035248U_ABST
Abstract
Description
Technical Field
[0001] This utility model relates to the field of platelet aggregation function detection technology, and specifically to a platelet aggregation function detection reagent card. Background Technology
[0002] Platelet aggregation function is an important way in which platelets participate in the hemostatic and coagulation process. Platelet aggregation function testing is of great significance in monitoring the efficacy of antiplatelet drugs, assessing the risk of thrombosis in high-risk groups, and evaluating the risk of bleeding during surgery, as well as other bleeding and thrombotic risk events.
[0003] The detection of platelet aggregation function usually uses optical turbidimetry, which requires two centrifugation operations with different centrifugation forces to separate platelet-rich plasma and platelet-poor plasma from whole blood samples. The operation is cumbersome and results in low detection efficiency. Utility Model Content
[0004] In view of this, the present invention provides a platelet aggregation function detection reagent card to solve the problem that conventional platelet separation operations are cumbersome and result in low detection efficiency.
[0005] This utility model provides a platelet aggregation function detection reagent card, comprising:
[0006] The shell includes a sample compartment, a separation zone, an anemic platelet-containing cavity, and a platelet-rich cavity. The sample compartment has an opening facing the outside. The inlet of the separation zone is connected to the sample compartment through a liquid inlet channel. The separation zone includes a first separation channel connected to the anemic platelet-containing cavity and a second separation channel connected to the platelet-rich cavity. The first separation channel and the second separation channel are respectively filled with a first packing material and a second packing material. The pore size formed by the second packing material is larger than that of the first packing material.
[0007] Optionally, the separation zone includes a buffer chamber, one end of which has an inlet and the other end has an outlet. The outlet is provided with a liquid outlet channel, and the first separation channel and the second separation channel are connected in parallel with the liquid outlet channel.
[0008] Optionally, the buffer chamber further includes a liquid passage, the middle sidewall of which is connected to the downstream of the liquid outlet channel, and the two ends of which are connected to the first separation channel and the second separation channel, respectively.
[0009] Optionally, one end of the first separation channel is provided with a first upper partition and the other end is provided with a first lower partition, and the first filler is filled between the first upper partition and the first lower partition; one end of the second separation channel is provided with a second upper partition and the other end is provided with a second lower partition, and the second filler is filled between the second upper partition and the second lower partition.
[0010] Optionally, the first and second fillers are composed of hydrophilic polymer materials and multi-arm crosslinking agents.
[0011] Optionally, the separation zone is arranged parallel to the sample chamber and has a gap between them, and the liquid inlet channel extends curvedly from the bottom of the sample chamber and passes through the gap to communicate with the inlet of the separation zone.
[0012] Optionally, a plurality of the anemic platelet-containing cavities are connected in parallel downstream of the first separation channel, and a plurality of the rich platelet-containing cavities are connected in parallel downstream of the second separation channel.
[0013] Optionally, the sample chamber has a cylindrical structure, and a puncture needle is provided on the bottom wall of the sample chamber. The puncture needle is located at the center of the bottom wall, with one end extending towards the opening and the other end passing through the bottom wall and communicating with the liquid inlet channel. A sealing gasket fitted on the puncture needle is provided on the bottom wall of the sample chamber.
[0014] Optionally, the anemic platelet-containing cavity and the rich platelet-containing cavity are respectively provided with a breathable structure that communicates with the outside.
[0015] Optionally, a handle is provided on the housing.
[0016] Beneficial effects:
[0017] The platelet aggregation function test kit provided by this utility model includes: a shell. The shell is provided with a sample compartment, a separation zone, an anemic platelet-containing cavity, and a platelet-rich cavity. The sample compartment has an opening facing the outside. The inlet of the separation zone is connected to the sample compartment through a liquid inlet channel. The separation zone includes a first separation channel connected to the anemic platelet-containing cavity and a second separation channel connected to the platelet-rich cavity. The first separation channel and the second separation channel are respectively filled with a first packing material and a second packing material. The pore size formed by the second packing material is larger than that of the first packing material.
[0018] In use, the sample tube can be inserted into the sample chamber through the opening. The blood in the sample tube enters the separation zone through the inlet and outlet channels, and then enters the first and second separation channels respectively. During this process, since the pore size of the second packing material is larger than that of the first packing material, platelet-rich plasma can be obtained through the first separation channel, and platelet-rich plasma can be obtained through the second separation channel. Platelet-rich plasma can enter the platelet-rich cavity, and platelet-rich plasma can enter the platelet-rich cavity. This achieves the separation, acquisition, and containment of platelet-rich plasma and platelet-rich plasma. Compared with existing technologies, it eliminates the need for two centrifugations and multiple reaction cups for separate containment, simplifying the operation process, improving separation efficiency, and thus improving subsequent detection efficiency. Attached Figure Description
[0019] To more clearly illustrate the specific embodiments of this utility model or the technical solutions in the prior art, the drawings used in the description of the specific embodiments or the prior art will be briefly introduced below. Obviously, the drawings described below are some embodiments of this utility model. For those skilled in the art, other drawings can be obtained from these drawings without creative effort.
[0020] Figure 1 This is a schematic diagram of the platelet aggregation function detection reagent card according to an embodiment of the present invention;
[0021] Figure 2 for Figure 1 A partial enlarged view of the first separation channel shown;
[0022] Figure 3 for Figure 1 A partially enlarged view of the second separation channel shown;
[0023] Figure 4 This is a three-dimensional structural diagram of the platelet aggregation function detection reagent card according to an embodiment of the present invention;
[0024] Figure 5 This is a linear fitting graph of the experimental results of an embodiment of this utility model;
[0025] Figure 6 This is a schematic diagram of the heating module according to a novel embodiment of the present invention;
[0026] Figure 7 This is a schematic diagram of the heating module according to an embodiment of the present invention.
[0027] Explanation of reference numerals in the attached figures:
[0028] 1. Shell; 2. Handle; 3. Sample compartment; 31. Sealing gasket; 4. Puncture needle; 51. Liquid inlet channel; 52. First separation channel; 521. First packing material; 522. First upper partition; 523. First lower partition; 524. First liquid storage channel; 53. Second separation channel; 531. Second packing material; 532. Second upper partition; 533. Second lower partition; 534. Second liquid storage channel; 54. Buffer chamber; 55. Liquid outlet channel; 56. Liquid transfer channel; 61. Platelet-rich chamber; 62. Platelet-rich chamber; 71. Vent; 72. Exhaust vent; 81. First dispensing channel; 82. Second dispensing channel; 101. First transparent window; 102. Second transparent window; 12. Heating module. Detailed Implementation
[0029] To make the objectives, technical solutions, and advantages of the embodiments of this utility model clearer, the technical solutions of the embodiments of this utility model will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of this utility model, not all embodiments. Based on the embodiments of this utility model, all other embodiments obtained by those skilled in the art without creative effort are within the protection scope of this utility model.
[0030] like Figure 1 and Figure 2 As shown, this embodiment provides a platelet aggregation function test kit, including: a housing 1. The housing 1 is provided with a sample compartment 3, a separation zone, an anemic platelet receiving cavity 61 and a platelet-rich receiving cavity 62. The sample compartment 3 has an opening facing the outside. The inlet of the separation zone is connected to the sample compartment 3 through a liquid inlet channel 51. The separation zone includes a first separation channel 52 connected to the anemic platelet receiving cavity 61 and a second separation channel 53 connected to the platelet-rich receiving cavity 62. The first separation channel 52 and the second separation channel 53 are respectively filled with a first packing material 521 and a second packing material 531. The pore size formed by the second packing material 531 is larger than the pore size of the first packing material 521.
[0031] In use, the sample tube can be inserted into the opening of the sample chamber 3. The blood in the sample tube enters the separation zone from the sample chamber 3 through the inlet channel 51 and the inlet, and then enters the first separation channel 52 and the second separation channel 53 respectively. During this process, since the pore size of the second packing material 531 is larger than that of the first packing material 521, platelet-rich plasma can be obtained through the first separation channel 52, and platelet-rich plasma can be obtained through the second separation channel 53. The platelet-rich plasma can enter the platelet-rich cavity 61, and the platelet-rich plasma can enter the platelet-rich cavity 62. This achieves the separation, acquisition and containment of platelet-rich plasma and platelet-rich plasma. Compared with the existing technology, it eliminates the need for two centrifugations and multiple reaction cups for separate containment, simplifying the operation process, improving the separation efficiency, and thus improving the subsequent detection efficiency.
[0032] like Figure 1 As shown, in this embodiment, the separation zone includes a buffer chamber 54, with an inlet at one end and an outlet at the other end. The outlet has a liquid outlet channel 55, and the first separation channel 52 and the second separation channel 53 are connected in parallel with the liquid outlet channel 55. The buffer chamber 54 buffers the blood sample, which reduces fluctuations in the blood sample flow rate, allowing the blood sample to stably pass through the liquid outlet channel 55 into the first separation channel 52 and the second separation channel 53 respectively, thus improving the accuracy of blood sample separation.
[0033] like Figure 1 As shown, in this embodiment, the buffer chamber 54 further includes a liquid passage 56. The middle sidewall of the liquid passage 56 is connected to the downstream of the outlet channel 55, and both ends of the liquid passage 56 are connected to the first separation channel 52 and the second separation channel 53, respectively. The liquid passage 56 can further buffer the blood sample, reduce the flow rate fluctuation of the blood sample, and allow the liquid sample to slowly permeate into the first separation channel 52 and the second separation channel. The liquid passage 56 is symmetrically arranged with respect to the extension direction of the outlet channel 55, so that the blood pressure at the inlet of the first separation channel 52 and the inlet of the second separation channel 53 is the same. The only control variable is the gap size of the first separation channel 52 and the second separation channel 53, which further improves the accuracy of blood sample separation.
[0034] like Figure 2 As shown, in this embodiment, a first upper partition 522 is provided at one end of the first separation channel 52, and a first lower partition 523 is provided at the other end. The first packing 521 is filled between the first upper partition 522 and the first lower partition 523, thereby fixing the first packing 521 in the first separation channel 52, preventing the first packing 521 from shifting and causing a change in pore size, and avoiding affecting the separation results.
[0035] The same principle applies, such as Figure 3As shown, a second upper baffle 532 is provided at one end of the second separation channel 53, and a second lower baffle 533 is provided at the other end. The second packing 531 is filled between the second upper baffle 532 and the second lower baffle 533, thereby fixing the second packing 531.
[0036] In this embodiment, a first liquid storage channel 524 is provided downstream of the first separation channel 52. The size of the first liquid storage channel 524 gradually decreases along the liquid flow direction, thereby preventing the first lower partition 523 from entering the first liquid storage channel 524, thus limiting the first lower partition 523, and further limiting the first packing 521 and the first upper partition 522.
[0037] Similarly, a second liquid storage channel 534 is provided downstream of the second separation channel 53. The size of the second liquid storage channel 534 gradually decreases along the liquid flow direction, thereby preventing the second lower baffle 533 from entering the second liquid storage channel 534, thus limiting the second lower baffle 533, and further limiting the second packing 531 and the second upper baffle 532.
[0038] like Figure 1 As shown, in this embodiment, multiple anemic platelet-containing cavities 61 are connected in parallel downstream of the first separation channel 52, and multiple platelet-rich cavities 62 are connected in parallel downstream of the second separation channel 53. This yields multiple independent anemic platelet plasma samples and platelet-rich plasma samples, facilitating parallel control during testing.
[0039] For example, a first dispensing channel 81 is connected downstream of the first reservoir channel 524. The first dispensing channel includes a main channel and multiple sub-channels corresponding to and connected to the number of anemic platelet-containing cavities 61, thereby ensuring that different anemic platelet-containing cavities 61 can accommodate anemic platelet plasma. A second dispensing channel 82 is connected downstream of the second reservoir channel 534. The second dispensing channel 82 includes a main channel and multiple sub-channels corresponding to and connected to the number of platelet-rich cavities 62, thereby ensuring that different platelet-rich cavities 62 can accommodate platelet-rich plasma.
[0040] In this embodiment, the shell 1 is plate-shaped, and multiple anemic platelet-containing cavities 61 and multiple rich platelet-containing cavities 62 are arranged side by side at the bottom of the shell 1.
[0041] like Figure 2As shown, in this embodiment, the first filler 521 and the second filler 531 are composed of a hydrophilic polymer material and a multi-arm crosslinking agent. The hydrophilic polymer material includes polyvinylpyrrolidone, polyacrylamide, cellulose and its derivatives, chitosan and its derivatives, polyamino acids, polypeptides, proteins, polyvinyl alcohol, etc. The multi-arm crosslinking agent includes biarm glycidyl ether, multiarm glycidyl ether, biarm aldehyde, multiarm aldehyde, biarm isocyanate, multiarm isocyanate, biarm succinimidyl ester, multiarm succinimidyl ester, biarm maleic anhydride, multiarm maleic anhydride, etc., or any combination of the above-mentioned different functional groups on the same crosslinking agent molecule.
[0042] By mixing hydrophilic polymers and crosslinking agents at different concentrations and ratios, injecting the mixture into a mold for a crosslinking reaction, and then freeze-drying it after the reaction, separation modules with different degrees of separation are obtained. Fillers with different degrees of separation are then loaded into the corresponding separation channels.
[0043] like Figure 1 As shown, in this embodiment, the separation zone and the sample chamber 3 are arranged in parallel with a gap between them. The liquid inlet channel 51 extends from the bottom of the sample chamber 3 in a curved manner and passes through the gap to communicate with the inlet of the separation zone, thereby making the structure compact.
[0044] like Figure 1 and Figure 4 As shown, in this embodiment, the sample chamber 3 has a cylindrical structure. A puncture needle 4 is provided on the bottom wall of the sample chamber 3. The puncture needle 4 is located at the center of the bottom wall, with one end extending towards the opening and the other end passing through the bottom wall and communicating with the liquid inlet channel 51. A sealing gasket 31 is provided on the bottom wall of the sample chamber 3, fitted onto the puncture needle 4. The cylindrical structure of the sample chamber 3 facilitates alignment with the blood collection tube, allowing the blood collection tube to accurately align with the puncture needle 4. The puncture needle 4 can penetrate the sealing cap of the blood collection tube, allowing blood to enter the liquid inlet channel 51 through the puncture needle 4. The sealing gasket 31 prevents blood in the blood collection tube from flowing out from the puncture point of the sealing cap.
[0045] like Figure 1 As shown, in this embodiment, the anemic platelet-containing cavity 61 and the rich platelet-containing cavity 62 are respectively provided with a ventilated structure that communicates with the outside. The ventilated structure may include an air outlet 71 provided on each cavity. The air outlet 71 can communicate with the outside, thereby venting the gas in the cavity and allowing the blood sample to fill the cavity.
[0046] like Figure 1As shown, in this embodiment, the ventilated structure also includes a gas channel that is connected to multiple air outlets 71 respectively, and an exhaust port 72 disposed on the gas channel. The exhaust port 72 is connected to the outside, so that the gas in each containment cavity can enter the gas channel through its own air outlet 71 and then be discharged from the exhaust port 72, reducing the probability of each containment cavity coming into contact with the outside air and avoiding contamination of the containment cavity.
[0047] like Figure 1 As shown, in this embodiment, a handle 2 is provided on the housing 1, which makes it easy for the operator to lift the housing 1.
[0048] like Figure 4 As shown, in this embodiment, a first transparent window 101 is provided on the anemic platelet receiving cavity 61, and a second transparent window 102 is provided on the rich platelet receiving cavity 62. The transparent windows facilitate transmittance detection. To clearly illustrate the usage and effect of the platelet aggregation function detection reagent card provided in this embodiment, a specific experimental example will be used for explanation below.
[0049] Two tubes of whole blood were drawn from the antecubital vein of one volunteer, 2 mL per tube.
[0050] One tube was used to detect platelet aggregation function using the gold standard method, optical transilluminance turbidimetry (LTA), with ADP (adenosine diphosphate) as the activator at a final concentration of 10 μM. The other tube used the platelet aggregation function detection kit provided in this embodiment as the experimental group.
[0051] The standard experimental group of the gold standard method involved centrifuging one tube of blood sample at 200g for 10 minutes, removing the supernatant platelet-rich plasma (PRP), and then centrifuging the sample tube again at 1000g for 5 minutes to remove the supernatant platelet-poor plasma (PPP). Following the LTA method instrument operation, the transmittance of PPP was first measured, then the sample was replaced with PRP to continue monitoring the transmittance of the reaction system. An activator was added, and the transmittance of the PRP sample was monitored for 5 minutes. The maximum platelet aggregation rate was 88%, exceeding the threshold of 52%, indicating normal platelet aggregation function.
[0052] The packing materials in the first separation channel 52 and the second separation channel 53 of this embodiment can be prepared as follows: Deacetylated chitosan is dissolved in 100mM pH 8.0 PBS to a solution of 100 mg / mL, and glutaraldehyde is used as a crosslinking agent with a concentration of 200 mg / mL. After mixing thoroughly, the mixture is reacted at room temperature for 4 hours, and then freeze-dried to obtain the first packing material 521. The first packing material 521 is then loaded into the first separation channel 52 for filtering and separating platelet-rich plasma. Similarly, deacetylated chitosan is dissolved in 100mM pH 8.0 PBS to a solution of 100 mg / mL, and glutaraldehyde is used as a crosslinking agent with a concentration of 50 mg / mL. After mixing thoroughly, the mixture is reacted at room temperature for 4 hours, and then freeze-dried to obtain the second packing material 531 for filtering and separating platelet-rich plasma. The final ADP concentration is 10 μM. After continuous monitoring for 5 minutes, the maximum platelet aggregation rate is 85%, which is basically consistent with the 88% result of the LTA method, indicating that the method is effective.
[0053] Since the platelet-rich plasma in the platelet-rich cavity 62 needs to be stirred during the experiment, platelet-activating reagents and magnetic beads can be added to the platelet-rich cavity 62. Commonly used platelet-activating reagents include ADP, AA, adrenaline, ristocetine, and collagen, etc. ADP is adenosine diphosphate, and AA is arachidonic acid. Magnetic beads can be used in conjunction with the detection equipment for stirring.
[0054] Further experiments were conducted based on the above method, increasing the sample size. Platelet-rich plasma and anemic plasma were separated according to the gold standard method and the structure of this embodiment, respectively. ADP was used as an activator to detect the maximum platelet aggregation rate, and the following data were obtained.
[0055]
[0056]
[0057] like Figure 5 As shown, a linear regression analysis of the results from the two methods yielded a coefficient of determination (R²) of 0.9884, indicating a good linear regression fit between the two methods. Therefore, the platelet aggregation function detection kit provided in this embodiment is effective in separating platelet-poor and platelet-rich plasmas.
[0058] The platelet aggregation function test kit of this invention can detect the aggregation function through a testing device. The testing device can be set with a detection position for placing the housing 1. The opposite sides of the detection position have an incident light emitter and a transmitted light receiver, so as to calculate the platelet aggregation function result by the change of light transmittance.
[0059] like Figure 6 and Figure 7As shown, the testing equipment also includes a temperature control module. After placing the housing 1 in the testing position, the temperature control module 12 can be tightly attached to the housing 1. The temperature control module 12 covers the separation area and downstream channel, but does not cover other areas, thus avoiding the sample chamber 3 and the receiving cavity. During testing, both sides of the housing 1 can be tightly attached to the temperature control module 12, and the two opposing temperature control modules 12 uniformly heat the housing 1. For example, the temperature control module 12 can be an aluminum block. After the testing equipment is turned on, the temperature control module 12 heats up to 37℃±0.5℃ at a rate of 5℃ / min to complete the preheating, and then maintains the temperature at 37℃±0.5℃ until the equipment is turned off, thereby providing the temperature required for testing and ensuring the accuracy of the test results.
[0060] In addition, the detection device also includes a processor, and a connection line between the temperature control module 12 and the processor. The processor is used to control the temperature of the temperature control module 12, control the operation of the incident light emitter and the transmitted light receiver, and process the light signal.
[0061] Although embodiments of the present invention have been described in conjunction with the accompanying drawings, those skilled in the art can make various modifications and variations without departing from the spirit and scope of the present invention, and such modifications and variations all fall within the scope defined by the appended claims.
Claims
1. A platelet aggregation function testing reagent card, characterized in that, The application relates to a blood platelet separation device. The device comprises a shell (1) provided with a sample chamber (3) having an opening facing the outside, a separation zone, a poor platelet containing cavity (61) and a rich platelet containing cavity (62), an inlet of the separation zone being communicated with the sample chamber (3) through a liquid inlet channel (51), the separation zone comprising a first separation channel (52) communicated with the poor platelet containing cavity (61) and a second separation channel (53) communicated with the rich platelet containing cavity (62), the first separation channel (52) and the second separation channel (53) being filled with a first filler (521) and a second filler (531) respectively, the pore diameter of the second filler (531) being larger than that of the first filler (521).
2. The test kit for platelet aggregation function according to claim 1, wherein The separation zone comprises a buffer cavity (54), one end of the buffer cavity (54) being provided with the inlet, the other end of the buffer cavity (54) being provided with an outlet, the outlet being provided with a liquid outlet channel (55), the first separation channel (52) and the second separation channel (53) being parallel to the liquid outlet channel (55).
3. The test kit for platelet aggregation function according to claim 2, wherein The buffer cavity (54) further comprises a liquid passing channel (56), the middle side wall of the liquid passing channel (56) being communicated with the downstream of the liquid outlet channel (55), the two ends of the liquid passing channel (56) being communicated with the first separation channel (52) and the second separation channel (53) respectively.
4. The test kit for platelet aggregation function according to claim 1, wherein One end of the first separation channel (52) is provided with a first upper partition plate (522), the other end is provided with a first lower partition plate (523), the first filler (521) being filled between the first upper partition plate (522) and the first lower partition plate (523); one end of the second separation channel (53) is provided with a second upper partition plate (532), the other end is provided with a second lower partition plate (533), the second filler (531) being filled between the second upper partition plate (532) and the second lower partition plate (533).
5. The test kit for platelet aggregation function according to claim 1, wherein The first filler (521) and the second filler (531) are composed of a hydrophilic polymer material and a multi-arm crosslinking agent.
6. The test kit for platelet aggregation function according to claim 1, wherein The separation zone is parallel to the sample chamber (3) and has a gap therebetween, the liquid inlet channel (51) is curvedly extended from the bottom of the sample chamber (3) and communicated with the inlet of the separation zone through the gap.
7. The test kit for platelet aggregation function according to claim 1, wherein A plurality of the poor platelet containing cavities (61) are connected in parallel downstream of the first separation channel (52), and a plurality of the rich platelet containing cavities (62) are connected in parallel downstream of the second separation channel (53).
8. The test kit for platelet aggregation function according to claim 1, wherein The sample chamber (3) is in a cylindrical structure, the bottom wall of the sample chamber (3) is provided with a puncture needle (4) located at the center of the bottom wall, one end of the puncture needle (4) extending towards the opening, the other end penetrating through the bottom wall and communicated with the liquid inlet channel (51), the bottom wall of the sample chamber (3) is provided with a sealing gasket (31) sleeved on the puncture needle (4).
9. The test reagent card for platelet aggregation function according to claim 1, wherein The poor platelet containing cavity (61) and the rich platelet containing cavity (62) are respectively provided with a gas permeable structure communicated with the outside.
10. The test kit for platelet aggregation function according to claim 1, wherein The shell (1) is provided with a handle (2).