A preparation device for platelet plasma

Abstract

This application relates to the field of filtration equipment, specifically to a platelet-rich plasma (PRP) preparation device, comprising a cylinder, a piston, a piston push rod, a top cover, and a shut-off valve. The cylinder and top cover are hollow structures, with the upper end of the cylinder detachably connected to the top cover. The piston push rod, after being connected to the piston, is inserted into the cylinder along its rear end. The shut-off valve penetrates the cylinder radially, and the cylinder has a mating part that cooperates with the shut-off valve. The shut-off valve moves horizontally along its own axis within the mating part. The shut-off valve has a first through hole and a second through hole extending along its axial direction, and a filter membrane assembly is disposed within the second through hole. In this application, the first and second through holes of the shut-off valve correspond to a first and a second position, respectively. During the horizontal displacement of the shut-off valve, the first and second positions can be switched, thereby enabling the device to selectively produce leukocyte-poor PRP or leukocyte-rich PRP. This application has the advantages of simple structure and easy operation.

Description

Technical Field

[0001] This application relates to the field of filtration equipment, and more specifically to a platelet plasma preparation apparatus. Background Technology

[0002] Platelet-rich plasma (PRP) is a platelet-rich product obtained by centrifuging whole blood. Based on the concentration of white blood cells in the prepared PRP, it is divided into leukocyte-poor platelet-rich plasma (P-PRP) and leukocyte-rich platelet-rich plasma (L-PRP). PRP with different white blood cell contents has different effects on cell regeneration and tissue healing. The mechanism of action of platelet-rich plasma (PRP) lies in the activation of platelets, which release a large number of growth factors that promote tissue repair and regeneration. Leukocyte-rich PRP, due to its high leukocyte content, plays a crucial antibacterial role in surgeries with high infection risks. However, because the leukocyte concentration in PRP is significantly higher than in PRP with low leukocyte counts, pro-inflammatory factors can adversely affect chondrocytes, stimulating cellular catabolism. Consequently, PRP with high leukocyte counts has a lower promoting effect on chondrocyte proliferation and migration compared to PRP with low leukocyte counts. Therefore, PRP with low leukocyte counts is more suitable for treating soft tissue injuries such as osteoarthritis and tennis elbow. It is evident that both PRP with high leukocyte counts and PRP with low leukocyte counts have wide applications in the medical field.

[0003] However, existing platelet plasma preparation devices can only produce leukocyte-rich PRP or leukocyte-poor PRP, which are characterized by limited functionality and cumbersome operation.

[0004] Therefore, there is an urgent need for a new type of platelet plasma preparation device to solve the problems of existing preparation devices having limited functions and cumbersome operation. Summary of the Invention

[0005] The purpose of this application is to provide a platelet plasma preparation apparatus to solve the problems existing in the prior art.

[0006] The embodiments of this application can be implemented through the following technical solutions: A platelet plasma preparation device includes a cylinder, a piston, a piston push rod, and a top cover. The cylinder and the top cover are hollow structures. The upper end of the cylinder is detachably connected to the top cover. After the piston push rod is connected to the piston, it is inserted into the cylinder along the rear end of the cylinder.

[0007] The device also includes a shut-off valve that passes through the cylinder radially. The cylinder is provided with a mating part that cooperates with the shut-off valve. The shut-off valve can be horizontally displaced within the mating part along its own axis, which can divide the cylinder into two independent upper and lower parts. The blocking valve has a first through hole and a second through hole that extend along its axial direction, and a filter membrane assembly is disposed in the second through hole.

[0008] Furthermore, the filter membrane assembly includes at least two filter membranes, and multiple filter membranes are arranged sequentially along the axial direction of the second through hole, with adjacent filter membranes connected circumferentially by a connector.

[0009] Furthermore, the filter membrane facing the piston end of the filter membrane assembly is the first filter membrane, and the filter membrane facing the upper cover end is the end filter membrane; The pore size of the filter membrane assembly gradually decreases from the first filter membrane to the end filter membrane.

[0010] Furthermore, at least one third through hole is provided on the first filter membrane, and the end filter membrane is a complete filter membrane structure.

[0011] Furthermore, the cylinder comprises, from top to bottom, a plasma containing section, a white film separation section, and an extraction section. The upper end of the plasma containing section is detachably connected to the upper cover. The piston is contained within the extraction section and can be displaced axially along the extraction section. The white film separation section is provided with a mating part that cooperates with the blocking valve.

[0012] Furthermore, the white membrane separation section has a hollow cylindrical structure, and its diameter is smaller than that of the plasma containing section and the extraction section.

[0013] Furthermore, the upper end of the plasma containing section is a hollow cylindrical structure, which can be detachably connected to the upper cover; the lower end is a hollow inverted frustum structure, and is connected to the white membrane layer separation section.

[0014] Furthermore, the upper end of the extraction section is a hollow frustum structure and is connected to the white film layer separation section; the lower end is a hollow cylinder structure and cooperates with the piston.

[0015] The platelet plasma preparation apparatus provided in the embodiments of this application has at least the following beneficial effects: (1) The device in this application is equipped with a blocking valve, and the blocking valve is provided with a first through hole and a second through hole. A filter membrane assembly is provided in the second through hole, so that the blocking valve can switch between the first position and the second position during the horizontal displacement process, thereby enabling the device to selectively produce leukocyte-poor PRP or leukocyte-rich PRP, which has the advantages of simple structure and easy operation. (2) The first filter membrane of the filter membrane assembly in this application has at least one third through hole, which can greatly improve the flow rate and velocity of filtration, reduce the filtration pressure of the first filter membrane, and thus achieve the effect of preventing the first filter membrane from clogging. (3) The whole blood in this application will come into contact with the anticoagulant, making it less likely for the plasma to coagulate into clumps when passing through the filter membrane assembly, further reducing the possibility of filter membrane blockage, ensuring the filtration effect, and improving the production efficiency of anemic leukocyte PRP. (4) The device in this application is provided with a blocking valve, and the white membrane layer separation section is provided with a mating part that cooperates with the blocking valve. The blocking valve can be horizontally displaced along its own axis within the mating part, thereby separating the white membrane layer separation section and the extraction section into two independent parts, thereby achieving the isolation of the white membrane layer and the red blood cells, preventing the white membrane layer and the red blood cells from mixing during the movement of the device, and having the advantage of stable layering. (5) The blocking valve in this application can be moved with just one hand, which has the advantage of being easy to operate; (6) The device in this application can realize the connection, processing and extraction of whole blood by itself without the need for other consumables, which reduces the number of disposable consumables during the extraction process, significantly reduces the cost, and reduces the loss of target material during the transfer of different consumables. It has the advantages of reasonable structure, simple operation, high extraction efficiency and low extraction cost. Attached Figure Description

[0016] Figure 1 This is a side view of a platelet plasma preparation apparatus according to this application; Figure 2 This is a cross-sectional view of a platelet plasma preparation apparatus according to this application; Figure 3 This is an exploded view of a platelet plasma preparation apparatus according to this application; Figure 4 This is an overall structural diagram of the shut-off valve in this application; Figure 5 This is a cross-sectional view of the second through hole in this application.

[0017] Reference numerals: 1. Cylinder, 11. Plasma containing section, 12. White membrane separation section, 13. Extraction section, 2. Piston, 3. Piston push rod, 4. Top cover, 5. Blocking valve, 51. First through hole, 52. Second through hole, 531. First filter membrane, 532. End filter membrane, 533. Third through hole. Detailed Implementation

[0018] The present application will now be further described based on preferred embodiments and with reference to the accompanying drawings.

[0019] The vocabulary used in this specification is for illustrative purposes and is not intended to limit the scope of this application. Unless otherwise expressly specified and limited, the terms "set," "connected," and "linked" should be interpreted broadly. For example, they can refer to a fixed connection, a detachable connection, or an integral connection; they can refer to a mechanical connection, a direct connection, or an indirect connection via an intermediate medium; or they can refer to the internal communication between two components. Those skilled in the art will understand the specific meaning of these terms in this application.

[0020] Furthermore, in the description of the embodiments of this application, various components on the drawings have been enlarged or reduced for ease of understanding, but this is not intended to limit the scope of protection of this application.

[0021] Figures 1-3 The following are shown: a side view, an exploded view, and a cross-sectional view of a platelet plasma preparation apparatus according to this application. Figures 1-3 As shown, the device includes a cylinder 1, a piston 2, a top cover 4, and a shut-off valve 5. The cylinder 1 and the top cover 4 are hollow structures. The cylinder 1 includes, from top to bottom, a plasma containing section 11, a white membrane separation section 12, and an extraction section 13. The upper end of the plasma containing section 11 is detachably connected to the top cover 4. The piston 2 is housed in the extraction section 13 and can be displaced axially along the extraction section 13. The shut-off valve 5 passes radially through the white membrane separation section 12 along the cylinder 1. The white membrane separation section 12 is provided with a mating part 121 that cooperates with the shut-off valve 5. The shut-off valve 5 is horizontally displaced along its own axis within the mating part 121, thereby separating the white membrane separation section 12 and the extraction section 13 into two independent parts, thus achieving the isolation of the white membrane and red blood cells and preventing the mixing of the white membrane and red blood cells during the movement of the device.

[0022] Furthermore, the blocking valve 5 has a first position, and when the blocking valve 5 is in the first position, the device can produce leukocyte-rich PRP.

[0023] Specifically, Figure 4 The overall structural diagram of the shut-off valve 5 in this application is shown, as follows: Figure 4 As shown, the shut-off valve 5 has a first through hole 51 extending along its axial direction. The inner diameter of the first through hole 51 is equal to the inner diameter of the white film separation section 12. When the first through hole 51 is aligned with the white film separation section 12, the shut-off valve 5 is in the first position. At this time, plasma can sequentially pass through the extraction section 13 and the first through hole 51 into the plasma receiving section 11.

[0024] Furthermore, the blocking valve 5 has a second position, and when the blocking valve 5 is in the second position, the device can produce leukopenic purpura plasma (PRP).

[0025] Specifically, such as Figure 4As shown, the blocking valve 5 has a second through hole 52 extending along its axial direction. A filter membrane assembly is installed inside the second through hole 52. The inner diameter of the second through hole 52 is equal to the inner diameter of the white blood cell separation section 12. When the second through hole 52 is aligned with the white blood cell separation section 12, the blocking valve 5 is in the second position. At this time, plasma can sequentially pass through the extraction section 13 and the filter membrane assembly into the plasma holding section 11. The filter membrane assembly can effectively block white blood cells.

[0026] Furthermore, since the filtration area of ​​each filter membrane is very limited, when the volume of plasma to be filtered is large, a larger filter membrane is required to achieve filtration. However, increasing the filter membrane area will inevitably increase the size of the device, which is not conducive to the miniaturization of the device. Figure 5 A cross-sectional view of the second through hole 52 in this application is shown, as follows. Figure 5 As shown, the filter membrane assembly of this application includes at least two filter membranes, and multiple filter membranes are arranged sequentially along the axial direction of the second through hole 52. The circumferential direction of adjacent filter membranes is connected by a connector to form a certain axial gap between adjacent filter membranes. In this way, the filtration area of ​​the filter assembly 53 is increased, and the miniaturization of the device is ensured. It has the advantages of simple structure, convenient operation and low production cost.

[0027] Furthermore, the filter membrane facing the extraction section 13 is the first filter membrane 531, and the filter membrane facing the plasma containing section 11 is the end filter membrane 532. The first filter membrane 531 and the end filter membrane 532 can be selectively provided with 0, 1 or more filter membranes as needed to achieve a good filtration effect.

[0028] Furthermore, the pore size of the filter membrane assembly gradually decreases from the first filter membrane 531 to the end filter membrane 532 to achieve a step-by-step filtration effect.

[0029] Furthermore, because each filter membrane has a limited filtration flow rate, when the volume of plasma to be filtered is large and the flow rate is fast, the filter membrane may not be able to filter in time, easily causing clogging and thus affecting the filtration effect. Therefore, as Figure 5 As shown, the first filter membrane 531 has at least one third through hole 533. The third through hole 533 allows some plasma to pass directly through the first filter membrane 531. This part of the plasma does not need to be filtered by the first filter membrane 531, which can greatly increase the flow rate and velocity of filtration, reduce the filtration pressure of the first filter membrane 531, and thus prevent the first filter membrane 531 from clogging. The end filter membrane 532 is a complete filter membrane structure, so that the plasma entering the plasma holding section 11 undergoes at least one filtration, thereby ensuring the filtration effect.

[0030] Furthermore, if one or more filter membranes are provided between the first filter membrane 531 and the end filter membrane 532, zero, one or more third through holes 533 can be opened on these filter membranes according to actual needs, so as to further enhance the plasma volume passing through the filter membrane assembly per unit time, meet the flow rate requirements of plasma passage, and achieve the effect of preventing filter membrane blockage.

[0031] Furthermore, the diameter of the third through-hole 533 on different filter membranes can be the same or different, and the diameter of the third through-hole 533 on different filter membranes can be set according to actual needs. Of course, the diameter of the third through-hole 533 on the same filter membrane can be the same or different.

[0032] In some specific embodiments of this application, such as Figure 5 As shown, Figure 5 Two filter membranes are provided between the first filter membrane 531 and the end filter membrane 532, that is, the filter membrane assembly is composed of 4 filter membranes. The first filter membrane 531 and the filter membrane near the end filter membrane 532 are provided with a third through hole 533, so that the filter membrane assembly has both a certain rigidity and strength, as well as good filtration efficiency and biocompatibility.

[0033] In some preferred embodiments of this application, the device further includes a piston push rod 3. After the piston push rod 3 is connected to the piston 2, it is inserted into the cylinder 1 along the rear end of the extraction section 13. The piston push rod 3 allows the user to easily apply force to the piston 2 to achieve axial displacement of the piston 2 along the extraction section 13.

[0034] In some preferred embodiments of this application, the cylinder 1 is made of a transparent material to facilitate observation of the layering and achieve accurate separation and extraction.

[0035] Furthermore, the white membrane separation section 12 has a hollow cylindrical structure and a diameter smaller than that of the plasma holding section 11 and the extraction section 13, thereby resulting in a higher white membrane liquid level in the white membrane separation section 12 and improving the extraction accuracy of platelets-rich plasma.

[0036] Furthermore, the upper end of the plasma containing section 11 is a hollow cylindrical structure that can be fitted with the upper cover 4, thereby achieving a detachable connection between the plasma containing section 11 and the upper cover 4; the lower end is a hollow inverted frustum structure, which is connected to the white film layer separation section 12, whose diameter is significantly smaller than that of the plasma containing section 11.

[0037] Furthermore, the upper end of the extraction section 13 is a hollow frustum structure, which connects to the white film layer separation section 12, whose diameter is significantly smaller than that of the extraction section 13; the lower end is a hollow cylindrical structure, which can cooperate with the piston 2 and the piston push rod 3 so that the piston 2 and the piston push rod 3 can move along the axial direction of the extraction section 13.

[0038] In some preferred embodiments of this application, the volume of the plasma accommodating segment 11 is 4 ml, 5 ml, or 6 ml.

[0039] In some preferred embodiments of this application, the volume of extraction segment 13 is 27 ml, 36 ml, or 45 ml.

[0040] In some preferred embodiments of this application, the piston 2 and the piston rod 3 are detachably connected in an elastic manner, so that the piston rod 3 can be easily disengaged from the piston 2.

[0041] Furthermore, in order to extract platelet-rich plasma, the upper part of the cover 4 is provided with a through hole and an external threaded connector for extracting leukocyte-rich PRP or leukocyte-poor PRP.

[0042] Furthermore, during use, whole blood to be processed needs to be introduced through the top cover 4. Therefore, a Luer connector is provided on the outside of the top cover 4, which can be connected to the blood collection line, so that the whole blood to be processed can be introduced into the cylinder 1 through the top cover 4.

[0043] In summary, the preparation process of leukocyte-rich PRP is as follows: First, the blocking valve 5 is set to the first position. Then, the anticoagulant is connected through the top cover 4 and introduced into the plasma holding section 11. Next, the external blood collection tube is connected through the top cover 4, and the whole blood to be processed is introduced into the cylinder 1. Then, the piston push rod 3 is disengaged from the piston 2, and the cylinder 1 containing the whole blood is placed in an external centrifuge for centrifugation. After centrifugation, the plasma is separated into two layers: red and yellow, with the red layer at the bottom. The piston push rod 3 is then connected to the piston 2, and the piston push rod 3 is pushed, thereby causing the piston 2 to move axially within the extraction section 13. This pushes the plasma in the cylinder 1 from the extraction section 13 to the white membrane layer separation section 12 and the plasma holding section 11. When the red and yellow interface reaches the upper surface of the blocking valve 5, the blocking valve 5 is pushed radially to separate the red layer from the yellow layer. Finally, the leukocyte-rich PRP is extracted from the cylinder 1 through the through hole at the top of the top cover 4.

[0044] In summary, the preparation process of anemic leukocyte PRP is as follows: First, the blocking valve 5 is set to the first position. Then, the anticoagulant is connected through the top cover 4 and introduced into the plasma holding section 11. Next, the external blood collection tube is connected through the top cover 4, and the whole blood to be processed is introduced into the cylinder 1. Then, the piston push rod 3 is disengaged from the piston 2, and the cylinder 1 containing the whole blood is placed in an external centrifuge for centrifugation. After centrifugation, the plasma is divided into three layers: red, white, and yellow, with the red layer at the bottom. At this time, the blocking valve 5 is pushed to the second position. Then, the piston push rod 3 is connected to the piston 2, and the piston push rod 3 is pushed, thereby causing the piston 2 to move axially within the extraction section 13. This pushes the plasma in the cylinder 1 from the extraction section 13 to the white membrane layer separation section 12 and the plasma holding section 11. When the red and white interface reaches the upper surface of the blocking valve 5, the blocking valve 5 is pushed radially to separate the red layer from the white layer. Then, the anemic leukocyte PRP is extracted from the cylinder 1 through the through hole at the top of the top cover 4.

[0045] Furthermore, since the whole blood in this application comes into contact with the anticoagulant, the plasma is less likely to coagulate when passing through the filter membrane assembly, further reducing the possibility of filter membrane blockage, ensuring filtration effect, and improving the production efficiency of anemic leukocyte PRP.

[0046] The following section will illustrate the efficiency of leukocyte-rich PRP production with specific data: (1) When the diameter of the white membrane separation section 12 is 5 mm, the diameter of the cylindrical part of the extraction section 13 is 30 mm, the angle of the frustum part of the extraction section 13 is 30°, the platelet content in the plasma holding section 11 is 2-3 times that of whole blood, and the white blood cell content is 2-3 times that of whole blood, at this time, a large number of platelets and white blood cells remain in the red part of the extraction section 13; (2) When the diameter of the white membrane separation section 12 is 8 mm, the diameter of the cylindrical part of the extraction section 13 is 30 mm, the angle of the frustum part of the extraction section 13 is 30°, the platelet content in the plasma holding section 11 is 3-4 times that of whole blood, and the white blood cell content is 2-3 times that of whole blood, at this time, a small amount of platelets and white blood cells remain in the red part of the extraction section 13; (3) When the diameter of the white membrane separation section 12 is 11 mm, the diameter of the cylindrical part of the extraction section 13 is 30 mm, the angle of the frustum part of the extraction section 13 is 30°, the platelet content in the plasma holding section 11 is 4-6 times that of whole blood, and the white blood cell content is 4-6 times that of whole blood, at this time, a small amount of platelets and white blood cells remain in the red part of the extraction section 13; (4) When the diameter of the white membrane separation section 12 is 11 mm, the diameter of the cylindrical part of the extraction section 13 is 30 mm, the angle of the frustum part of the extraction section 13 is 45°, the platelet content in the plasma holding section 11 is 5-6 times that of whole blood, and the white blood cell content is 4-6 times that of whole blood, at this time, a small amount of platelets and white blood cells remain in the red part of the extraction section 13, and the platelet recovery rate is ≥80%.

[0047] The following will illustrate the efficiency of PRP production from anemic leukocytes with specific data: (1) When the diameter of the white membrane layer separation section 12 is 5 mm, the diameter of the cylindrical part of the extraction section 13 is 30 mm, the angle of the frustum part of the extraction section 13 is 30°, the platelet content in the plasma holding section 11 is 2-3 times that of whole blood, and the white blood cell content is less than 1 times that of whole blood, at this time, a large number of platelets and white blood cells remain in the red part of the extraction section 13; (2) When the diameter of the white membrane separation section 12 is 8 mm, the diameter of the cylindrical part of the extraction section 13 is 30 mm, the angle of the frustum part of the extraction section 13 is 30°, the platelet content in the plasma holding section 11 is 3-4 times that of whole blood, and the white blood cell content is less than 1 times that of whole blood, at this time, a small amount of platelets and white blood cells remain in the red part of the extraction section 13. (3) When the diameter of the white membrane separation section 12 is 11 mm, the diameter of the cylindrical part of the extraction section 13 is 30 mm, the angle of the frustum part of the extraction section 13 is 30°, the platelet content in the plasma holding section 11 is 4-5 times that of whole blood, and the white blood cell content is less than 1 times that of whole blood, at this time, a small amount of platelets and white blood cells remain in the red part of the extraction section 13. (4) When the diameter of the white membrane separation section 12 is 11 mm, the diameter of the cylindrical part of the extraction section 13 is 30 mm, the angle of the frustum part of the extraction section 13 is 45°, the platelet content in the plasma holding section 11 is 5-6 times that of whole blood, and the white blood cell content is less than 1 times that of whole blood, at this time, a small amount of platelets and white blood cells remain in the red part of the extraction section 13, and the platelet recovery rate is ≥80%.

[0048] The data above shows that the filter membrane module can significantly reduce the content of white blood cells, thereby enabling the production of PRP for anemic white blood cells.

[0049] The specific embodiments of this application have been described in detail above. For those skilled in the art, several improvements and modifications can be made to this application without departing from the principle of this application, and these improvements and modifications also fall within the protection scope of the claims of this application.

Claims

1. A platelet plasma preparation apparatus, comprising a cylinder (1), a piston (2), a piston push rod (3), and a top cover (4), wherein the cylinder (1) and the top cover (4) are hollow structures, the upper end of the cylinder (1) is detachably connected to the top cover (4), and the piston push rod (3), after being connected to the piston (2), is inserted into the cylinder (1) along the rear end of the cylinder (1), characterized in that: The device also includes a shut-off valve (5), which passes through the cylinder (1) radially. The cylinder (1) is provided with a mating part (121) that cooperates with the shut-off valve (5). The shut-off valve (5) can be horizontally displaced within the mating part (121) along its own axis, which can divide the cylinder (1) into two independent upper and lower parts. The blocking valve (5) has a first through hole (51) and a second through hole (52) extending through it in the axial direction, and a filter membrane assembly is provided in the second through hole (52).

2. The platelet plasma preparation apparatus according to claim 1, characterized in that: The filter membrane assembly includes at least two filter membranes, and multiple filter membranes are arranged sequentially along the axial direction of the second through hole (52), and adjacent filter membranes are connected circumferentially by a connector.

3. The platelet plasma preparation apparatus according to claim 2, characterized in that: The filter membrane assembly has a first filter membrane (531) facing the piston (2) and an end filter membrane (532) facing the upper cover (4). The pore size of the filter membrane assembly gradually decreases from the first filter membrane (531) to the end filter membrane (532).

4. The platelet plasma preparation apparatus according to claim 3, characterized in that: The first filter membrane (531) has at least one third through hole (533), and the end filter membrane (532) is a complete filter membrane structure.

5. A platelet plasma preparation apparatus according to any one of claims 1-4, characterized in that: The cylinder (1) includes, from top to bottom, a plasma holding section (11), a white membrane layer separation section (12), and an extraction section (13). The upper end of the plasma holding section (11) is detachably connected to the upper cover (4). The piston (2) is housed in the extraction section (13) and can be displaced axially along the extraction section (13). The white membrane layer separation section (12) is provided with a mating part (121) that cooperates with the blocking valve (5).

6. The platelet plasma preparation apparatus according to claim 5, characterized in that: The white membrane separation section (12) has a hollow cylindrical structure and its diameter is smaller than that of the plasma holding section (11) and the extraction section (13).

7. The platelet plasma preparation apparatus according to claim 6, characterized in that: The upper end of the plasma containing section (11) is a hollow cylindrical structure, which can be detachably connected to the upper cover (4); the lower end is a hollow inverted frustum structure, and is connected to the white membrane layer separation section (12).

8. The platelet plasma preparation apparatus according to claim 6, characterized in that: The upper end of the extraction section (13) is a hollow frustum structure and is connected to the white film layer separation section (12); the lower end is a hollow cylinder structure and is matched with the piston (2).

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