Separation device capable of injecting concentrated growth factors

Abstract

The utility model relates to a separation device for injectable concentrated growth factors, which makes up the defects of the prior art in the preparation of injectable CGF, such as incapability of separation caused by blood coagulation in the preparation process, and incapability of slow release of growth factors due to inhibition of formation of a fibrous protein scaffold by using an anticoagulant. After blood sampling, blood is injected into the lower cavity of the separation device, PPP, CGF and RBC are obtained through a specific centrifugal program, the first piston assembly is pushed to enable the PPP on the upper layer to enter the upper cavity, the upper cover body is moved downwards to enable the third barrel to be communicated with the lower cavity, the first piston assembly is moved upwards to enable the CGF to enter the third barrel, and separation can be completed. During separation, only the piston needs to be pushed up and the upper cover body needs to be moved downwards, operation is simple, samples do not need to be transferred, the separation process is isolated from the outside, and safety is high; the prepared CGF can continuously and slowly release various autologous growth factors, and is beneficial to playing a continuous role in a long-term tissue repair process.

Description

Technical Field

[0001] This utility model relates to the field of medical experimental equipment technology, specifically to a separation device for injectable concentrated growth factors. Background Technology

[0002] Concentrated growth factors (CGF) were first reported by Sacco in 2005. It is a blood concentrate containing multiple growth factors, prepared from autologous peripheral blood via differential centrifugation. The preparation process does not involve the addition of anticoagulants; centrifugation directly yields an autologous, growth factor-rich fibrin gel. It possesses advantages such as high bioactivity, no immune rejection, and long-lasting effects, playing a crucial role in tissue repair and regeneration. After specific differential centrifugation, the blood separates into three layers: the top layer is liquid platelet-poor serum (PPP), the middle layer is gel-like concentrated growth factors (CGF), and the bottom layer is red blood cell clots (RBC). During differential centrifugation, the programmed switching between acceleration and deceleration promotes the conversion of fibrinogen into fibrin, forming a high-strength fibrin network that prevents growth factors from being hydrolyzed by proteins. The alternating centrifugal forces provide more opportunities for collisions with the centrifuge tube, leading to greater platelet rupture and the release of growth factors. Compared to platelet-rich plasma (PRP), CGF exhibits more complete platelet activation, and its fibrin network maintains and sustains the release of growth factors, more closely resembling the natural process of tissue healing. CGF has a wide range of applications, including dental implantology, plastic surgery, and dermatology, demonstrating broad application prospects.

[0003] However, existing concentrated growth factor preparation technologies have the following technical problems: After centrifugation, the CGF is in a gel state, making it unsuitable for injection therapy; vacuum blood collection tubes are often used as blood containers during preparation, and after centrifugation, the tube cap must be opened and tweezers used to remove the lumpy CGF, posing a high risk of contamination. Current preparation technologies require the addition of anticoagulants during centrifugation to obtain injectable CGF, which not only increases the risk of immune rejection but also inhibits fibrin polymerization. This type of CGF, after injection, cannot form a scaffold in the body and cannot play its role in maintaining and sustaining the release of growth factors.

[0004] Chinese utility model patent CN202410037415.X discloses a CGF separation and extraction device and its extraction method, including a CGF collection part, a sealing top cover, a preparation chamber, a separation piston, a lifting support part, a lower cover, and a lifting spiral component. The preparation chamber includes an upper separation chamber and a lower blood containing chamber, which are connected by a chamber channel. The sealing top cover is installed on the separation chamber, and the CGF collection part is installed inside the sealing top cover. The lifting support part is assembled and installed below the separation piston. The separation piston and the lifting support part are slidably and sealed in the blood containing chamber. The lower cover is installed in the lower opening of the blood containing chamber. The lifting spiral component is threadedly connected and installed in the lifting guide hole on the lower end face of the lower cover. The upper end of the lifting spiral component cooperates with the lower end of the lifting support part.

[0005] The above-mentioned solution has the following problems during use. Specifically, since no anticoagulant is added, blood is prone to clotting during centrifugation, and CGF cannot be transferred and injected after centrifugation. During operation, it is necessary not only to raise and lower the CGF collection section back and forth, but also to raise and lower the sealing cover at the same time to connect the blood containing chamber and the cavity inside the CGF collection section, or to make a gap between the chamber passage and the CGF collection section and the sealing cover. The operation is cumbersome, time-consuming and labor-intensive. Utility Model Content

[0006] (a) Technical problems to be solved

[0007] To address the above problems, this invention provides a separation device for injecting concentrated growth factors, which eliminates the need to move the upper cover and the second cylinder, making operation simpler, more convenient, and saving time and effort.

[0008] (II) Technical Solution

[0009] To achieve the above objectives, this utility model provides the following technical solution:

[0010] This invention provides a separation device for injectable concentrated growth factors, comprising:

[0011] The first cylinder is arranged vertically. The interior of the first cylinder is provided with an upwardly protruding first nipple. The first nipple can divide the interior of the first cylinder into an upper cavity located above and a lower cavity located below. The top of the first cylinder is detachably connected to an upper cover for sealing, and the bottom of the first cylinder is detachably connected to a lower cover for sealing.

[0012] The second cylinder is fixedly connected to the bottom of the upper cover and is vertically continuous. The bottom of the second cylinder is provided with a downward protrusion corresponding to the first nipple. There is a gap between the second nipple and the first nipple. The gap can be reduced by moving the upper cover down.

[0013] The third cylinder is connected to the interior of the second cylinder and is vertically continuous. The bottom of the third cylinder is provided with a downwardly protruding third nipple corresponding to the first nipple. The outer wall of the third nipple is slidably connected to the inner wall of the second nipple. The third nipple has a first state of abutting against the first nipple and a second state of not abutting against the first nipple. When the third nipple is in the first state, the third cylinder is connected to the lower cavity. When the third nipple is in the second state, the third cylinder is connected to the upper cavity. The second state is the initial state. Moving the upper cover down can cause the second cylinder to move the third cylinder down, thereby changing the third nipple to the first state.

[0014] A first piston assembly is sealed and slidably connected inside the lower cavity, and can be close to or away from the first nipple;

[0015] The second piston assembly is sealed and slidably connected inside the third cylinder, and can be close to or away from the third nipple.

[0016] Preferably, the first piston assembly includes:

[0017] A screw, which is vertically arranged and threadedly connected to the middle of the lower cover, has a first end and a second end that are far apart from each other, the first end being located inside the first cylinder and the second end being located outside the first cylinder;

[0018] A support member, the support member being made of a rigid material, the bottom of the support member being connected to the first end of the screw, so that the support member can move up and down as the screw rotates;

[0019] The first plug is made of a flexible material. The bottom of the first plug is detachably connected to the top of the support to fix the relative position of the first plug and the support. The side of the first plug is slidably connected to the inner wall of the first cylinder to prevent the liquid in the lower cavity from leaking from below.

[0020] Preferably, the support member is provided with an injection hole, one end of which abuts against the first plug, and the other end is offset from the screw.

[0021] Preferably, the second piston assembly includes:

[0022] The core rod is vertically arranged and slidably connected to the inner wall of the third cylinder. The core rod has a driving end and a driven end that are far apart from each other. The driving end is located outside the third cylinder, and the driven end is located inside the third cylinder.

[0023] The second plug is made of a flexible material. The top of the second plug is detachably connected to the driven end of the core rod to fix the relative position of the second plug and the core rod. The side of the second plug is slidably sealed to the inner wall of the third cylinder to prevent the liquid in the third cylinder from leaking from above.

[0024] Preferably, the upper cover has a first hole that connects the upper cavity to the outside. A breathable membrane is placed at the first hole and fixed by a fixing plug. The fixing plug has a breathable hole corresponding to the position of the first hole, so that the gas in the upper cavity and the gas in the outside can flow and exchange through the breathable membrane, and the gas passing through the breathable membrane is filtered, so that the air pressure in the upper cavity and the air pressure in the outside can be kept consistent, and the gas in the upper cavity and the gas in the outside can be prevented from being contaminated.

[0025] Preferably, the upper cover is provided with a second hole, which connects the upper cavity to the outside and is used to input fluid into the upper cavity or extract fluid from the upper cavity. A sealing plug for sealing is detachably connected to the second hole.

[0026] Preferably, the top of the first nipple is provided with an annular protrusion, and there is a gap between the top of the annular protrusion and the bottom of the second nipple. The inner wall of the annular protrusion can be slidably connected to the outer wall of the third nipple to enhance the sealing degree of the third nipple when it is in the first state.

[0027] Preferably, it also includes a plug, which is detachably connected to the top of the second cylinder and is used to seal the second cylinder after the third cylinder is removed.

[0028] Preferably, the first cylinder, the second cylinder, and the third cylinder are all made of transparent material to facilitate observation of the liquid separation process.

[0029] Preferably, both the first cylinder and the third cylinder are provided with graduations for observing the volume of the liquid.

[0030] (III) Beneficial Effects

[0031] Compared with the prior art, the beneficial effects of this utility model are:

[0032] In practical use, blood is injected into the lower cavity of the first cylinder and centrifuged. After centrifugation, the blood separates into three layers: PPP in the upper layer, CGF in the middle layer, and RBC in the lower layer. Then, the first piston assembly is moved upward, allowing the PPP in the lower cavity to enter the upper cavity through the first papilla. Next, the upper cover is moved downward, bringing the third papilla into contact with the first papilla. The first piston assembly continues to move upward, allowing the target product CGF in the lower cavity to pass through the first and third papilla sequentially, ultimately entering the interior of the third cylinder completely, thus obtaining concentrated growth factor CGF. Compared to existing technologies, because there is a gap between the second papilla on the second cylinder and the first papilla on the first cylinder, there is no need to move the upper cover and the second cylinder back and forth during the entire operation. Only the upper cover needs to be moved downward to complete the separation of CGF, simplifying the operation and making preparation more convenient and faster. In summary, by using this injectable concentrated growth factor separation device, CGF does not need to be transferred to a syringe; it can be directly injected after separation by connecting an injection needle. The operation is simpler and more convenient, saving time and effort. The separation process remains isolated from the outside environment, eliminating the risk of contamination.

[0033] Furthermore, this invention significantly slows down the polymerization rate of fibrin in CGF by controlling the centrifugation temperature and adjusting the centrifugation force. Under centrifugation temperature control, CGF can remain in a liquid state for 30-60 minutes, allowing the liquid CGF to be transferred to the third cylinder of the separation device for direct clinical injection. In vivo, CGF can rapidly form a gel scaffold by heating, protecting and sustaining the release of growth factors. This technology solves the technical defects of existing technologies, where gel-like CGF cannot be used for injection, and liquid CGF prepared with added anticoagulants cannot form a scaffold and sustain the release of growth factors after injection. Attached Figure Description

[0034] The accompanying drawings are provided to further illustrate the present invention and form part of the specification. They are used together with the embodiments of the present invention to explain the present invention, but do not constitute a limitation thereof. In the drawings:

[0035] Figure 1 A perspective view of the separation device for injectable concentrated growth factors of this invention is shown;

[0036] Figure 2 It shows Figure 1 A three-dimensional view of a vertical cross-section of the separation device for injectable concentrated growth factors when the third papilla is in the first state;

[0037] Figure 3 It shows Figure 2 Plan view at the cross-section;

[0038] Figure 4 It shows Figure 1A three-dimensional view of a vertical cross-section of the separation device for injectable concentrated growth factors when the third nipple is in the second state;

[0039] Figure 5 It shows Figure 4 Enlarged view of part A in the image;

[0040] Figure 6 It shows Figure 4 Enlarged view of part B in the image;

[0041] Figure 7 It shows Figure 1 A three-dimensional schematic diagram of the exploded structure of a separation device for injectable concentrated growth factors;

[0042] Figure 8 It shows Figure 7 Enlarged view of section C in the image;

[0043] Figure 9 It shows Figure 7 A three-dimensional diagram from another angle;

[0044] Figure 10 It shows Figure 7 A plan view of one side;

[0045] Figure 11 It shows Figure 1 A 3D view of the middle screw and the first handle;

[0046] Figure 12 It shows Figure 1 A three-dimensional view of the central support component;

[0047] Figure 13 It shows Figure 1 3D view of the central core rod and the second handle;

[0048] Figure 14 It shows Figure 1 A three-dimensional view of the separation device for injectable concentrated growth factors after the third cylinder has been removed and the plug has been connected;

[0049] Figure 15 It shows Figure 14 3D view of the center plug;

[0050] Figure 16 Experimental results show that injectable CGF can release growth factors under physiological conditions.

[0051] In the diagram: 1. First cylinder; 101. First nipple; 1011. Annular protrusion; 102. Upper cavity; 103. Lower cavity; 2. Second cylinder; 21. Second nipple; 3. Third cylinder; 31. Third nipple; 4. First piston assembly; 41. Screw; 411. First end; 412. Second end; 42. Support; 421. Injection hole; 43. First plug; 44. First handle; 5. Second piston assembly; 51. Core rod; 511. Driving end; 512. Driven end; 52. Second plug; 53. Second handle; 6. Upper cover; 7. Lower cover; 8. First hole; 81. Breathable diaphragm; 82. Fixed plug; 821. Breathing hole; 9. Second hole; 91. Sealing plug; 10. Plug; 11. Scale. Detailed Implementation

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

[0053] Example 1

[0054] See appendix Figure 1 - Appendix Figure 4This utility model discloses a separation device for injectable concentrated growth factors, including a first cylinder 1, a second cylinder 2, a third cylinder 3, a first piston assembly 4, and a second piston assembly 5. The first cylinder 1 is vertically continuous, and its interior has an upwardly protruding first nipple 101 that divides the interior of the first cylinder 1 into an upper cavity 102 and a lower cavity 103. A sealing upper cover 6 is detachably connected to the top of the first cylinder 1, and a sealing lower cover 7 is detachably connected to the bottom of the first cylinder 1. The second cylinder 2 is fixedly connected to the bottom of the upper cover 6 and is vertically continuous. The bottom of the second cylinder 2 has a downwardly protruding second nipple 21 corresponding to the first nipple 101. There is a gap between the second nipple 21 and the first nipple 101, which can be reduced by lowering the upper cover 6. The third cylinder 3 can be connected to... The second cylinder 2 is internally and vertically connected. The bottom of the third cylinder 3 is provided with a downward protrusion corresponding to the first nipple 101, and the outer wall of the third nipple 31 is slidably connected to the inner wall of the second nipple 21. The third nipple 31 has a first state of abutting against the first nipple 101 and a second state of not abutting against the first nipple 101. When the third nipple 31 is in the first state, the third cylinder 3 is connected to the lower cavity 103. When the third nipple 31 is in the second state, the third cylinder 3 is connected to the upper cavity 102. The second state is the initial state. Moving the upper cover 6 down can cause the second cylinder 2 to drive the third cylinder 3 to move down, thereby changing the third nipple 31 to the first state. The first piston assembly 4 is slidably and sealingly connected to the inside of the lower cavity 103 and can be close to or away from the first nipple 101. The second piston assembly 5 is slidably and sealingly connected to the inside of the third cylinder 3 and can be close to or away from the third nipple 31.

[0055] In actual use, blood is injected into the lower cavity 103 within the first cylinder 1 and centrifuged. After centrifugation, the blood separates into layers, yielding PPP in the upper layer, CGF in the middle layer, and RBC in the lower layer. Then, the first piston assembly 4 is moved upward, allowing the PPP in the lower cavity 103 to enter the upper cavity 102 through the first nipple 101. Next, the upper cover 6 is moved downward, positioning the third nipple 31 in the first state of contact with the first nipple 101. The first piston assembly 4 continues to move upward, allowing the target product CGF in the lower cavity 103 to pass sequentially through the first nipple 101 and the third nipple 31. Finally, the concentrated growth factor (CGF) is completely inserted into the interior of the third cylinder 3. Compared with the prior art, since there is a gap between the second nipple 21 on the second cylinder 2 and the first nipple 101 on the first cylinder 1, there is no need to move the upper cover 6 and the second cylinder 2 back and forth during the entire operation. The separation of CGF can be completed simply by moving the upper cover 6 down, which simplifies the operation steps and makes the preparation more convenient and faster. In general, by using this injectable concentrated growth factor separation device, there is no need to move the upper cover 6 and the second cylinder 2 back and forth, making the operation simpler, more convenient, and saving time and effort.

[0056] It should be noted that this application does not limit the method of detachable connection and sealing between the upper cover 6 and the first cylinder 1, or between the lower cover 7 and the first cylinder 1. The method can be flexibly selected according to actual needs. For example, detachable connection can be made by threaded connection, or sealing can be achieved by setting a sealing gasket at the connection point of the two components and applying pressure, etc.

[0057] See appendix Figure 2 and appendix Figure 9 - Appendix Figure 11 To allow the first piston assembly 4 to approach or move away from the first nipple 101, the following design is implemented in this embodiment. Specifically, the first piston assembly 4 includes a screw 41, a support member 42, and a first plug 43. The screw 41 is vertically arranged and threadedly connected to the middle of the lower cover 7. The screw 41 has a first end 411 and a second end 412 that are far apart from each other. The first end 411 is located inside the first cylinder 1, and the second end 412 is located outside the first cylinder 1. The support member 42 is made of a rigid material, and the bottom of the support member 42 is connected to the first end 411 of the screw 41 so that the support member 42 can move up and down as the screw 41 rotates. The first plug 43 is made of a flexible material, and the bottom of the first plug 43 is detachably connected to the top of the support member 42 to fix the relative position of the first plug 43 and the support member 42. The side of the first plug 43 is slidably connected to the inner wall of the first cylinder 1 to prevent the liquid in the lower cavity 103 from leaking from below.

[0058] With the above structural design, rotating the second end 412 of the screw 41 will cause the first end 411 of the screw 41 to drive the support member 42 and the first plug 43 to move up and down, thereby moving closer to or away from the first nipple 101, so that the first piston assembly 4 can push the liquid in the lower cavity 103 out from the first nipple 101.

[0059] It should be noted that this embodiment does not limit the connection method between the screw 41 and the support 42. It can be flexibly selected according to actual needs, such as a fixed connection or a rotating connection. Both can make the first plug 43 slide stably along the inner wall of the lower cavity 103 without tilting or affecting the sealing effect. In addition, this embodiment does not limit the way the support 42 and the first plug 43 are detachably connected. It can be flexibly designed, such as the common embedded snap-fit ​​connection.

[0060] See appendix Figure 1 and attached Figure 11 Furthermore, to facilitate the rotation of the screw 41, a first handle 44 can be provided at the second end 412 of the screw 41.

[0061] See appendix Figure 12 Furthermore, the following design is also made in this embodiment: Specifically, the support member 42 is provided with an injection hole 421, one end of the injection hole 421 abuts against the first plug body 43, and the other end is offset from the screw 41.

[0062] With the above structural design, blood can be injected into the lower cavity 103 without removing the first piston assembly 4 from the first cylinder 1. Specifically, the lower cover 7 is opened, the support 42 is moved to a position close to the bottom opening of the lower cavity 103, and then the metal injection needle is passed through the injection hole 421 and pierced through the first plug 43 made of flexible material, so that the blood in the syringe can be pushed into the lower cavity 103. After the injection is completed, the metal injection needle is pulled out. Since the first plug 43 is made of flexible material and has a certain thickness, it can play a sealing role to prevent blood from leaking downward from the first plug 43. Then the lower cover 7 is connected to the bottom of the first cylinder 1 to prepare concentrated growth factors.

[0063] Furthermore, the injection hole 421 can be tilted to facilitate the insertion and exit of the metal needle.

[0064] See appendix Figure 2 Appendix Figure 7 and attached Figure 13To allow the second piston assembly 5 to approach or move away from the third nipple 31, the following design is implemented in this embodiment: Specifically, the second piston assembly 5 includes a core rod 51 and a second plug 52. The core rod 51 is vertically arranged and slidably connected to the inner wall of the third cylinder 3. The core rod 51 has a driving end 511 and a driven end 512 that are far apart from each other. The driving end 511 is located outside the third cylinder 3, and the driven end 512 is located inside the third cylinder 3. The second plug 52 is made of a flexible material. The top of the second plug 52 is detachably connected to the driven end 512 of the core rod 51 to fix the relative position of the second plug 52 and the core rod 51. The side of the second plug 52 is slidably connected to the inner wall of the third cylinder 3 to prevent liquid in the third cylinder 3 from leaking from above.

[0065] With the above structural design, pulling the drive end 511 of the core rod 51 upward or pushing the drive end 511 of the core rod 51 downward will cause the driven end 512 of the core rod 51 to move the second plug 52 up and down, thereby moving it closer to or away from the third nipple 31. During the process of injecting liquid from the lower cavity 103 into the third cylinder 3, the second plug 52 can be moved upward through the core rod 51, thereby keeping the air pressure in the third cylinder 3 stable. After the third cylinder 3 is removed from the second cylinder 2, the second plug 52 can be moved downward through the core rod 51, thereby pushing out the liquid in the third cylinder 3.

[0066] See appendix Figure 1 and attached Figure 13 Furthermore, to facilitate pushing and pulling the core rod 51, a second handle 53 can be provided at the drive end 511 of the core rod 51.

[0067] See appendix Figure 4 Appendix Figure 5 and attached Figure 8 Since the separation device for injectable concentrated growth factors includes multiple chambers, the air pressure in these chambers may adversely affect the flow of the liquid during the liquid separation process. Therefore, the following design is made in this embodiment: Specifically, the upper cover 6 is provided with a first hole 8, which connects the upper cavity 102 to the outside. A breathable membrane 81 is placed at the first hole 8 and fixed by a fixing plug 82. The fixing plug 82 is provided with a breathable hole 821 corresponding to the position of the first hole 8.

[0068] Through the design of the above structure, the gas inside the upper cavity 102 and the gas outside can flow and exchange through the breathable membrane 81, so that the air pressure inside the upper cavity 102 and the air pressure outside can be kept consistent, preventing the liquid in the lower cavity 103 from being obstructed by air pressure during the input into the upper cavity 102; and because the breathable membrane 81 is provided, the flowing gas can be filtered to prevent the gas inside the upper cavity 102 and the gas outside from being contaminated. At the same time, the breathable membrane 81 also has a waterproof function, which can prevent the liquid in the injectable concentrated growth factor separation device from leaking through the first hole 8.

[0069] See appendix Figure 4 Appendix Figure 6 and attached Figure 8 Furthermore, in this embodiment, the following design is made: Specifically, the upper cover 6 is provided with a second hole 9, which connects the upper cavity 102 and the outside. A sealing plug 91 for sealing is detachably connected to the second hole 9.

[0070] With the above structural design, after opening the sealing plug 91, the needle can be inserted into the upper cavity 102 to accurately extract and separate PPP, enabling precise separation and extraction of PPP, CGF, and RBC. In addition, disinfectant gas or disinfectant liquid, such as ethylene oxide in sterilizing gas, can be injected into each chamber of the injectable concentrated growth factor separation device through the second hole 9 to disinfect each component, making it more convenient to use. Specifically, ethylene oxide in sterilizing gas is injected into the upper cavity 102 of the first cylinder 1 through the second hole 9. Since there is a gap between the second nipple 21 and the first nipple 101, ethylene oxide in the upper cavity 102 can enter the interior of the second cylinder 2 regardless of whether the third nipple 31 is in the first or second state, or whether the third nipple 31 protrudes from the second nipple 21. Moving the third cylinder 3 to the second state also allows ethylene oxide to enter the interior of the third cylinder 3 and the lower cavity 103 of the first cylinder 1, achieving a more comprehensive sterilization effect.

[0071] See appendix Figure 4 When the third nipple 31 and the first nipple 101 come into contact, only one surface is sealed. However, the volume of the third nipple 31 and the first nipple 101 is significantly small, that is, the contact area is small. Furthermore, due to the existence of processing errors, the two may not be able to make precise contact, which will affect the sealing performance after they come into contact. In order to solve the above problems, the following design is made in this embodiment. Specifically, the top of the first nipple 101 is provided with an annular protrusion 1011. There is a gap between the top of the annular protrusion 1011 and the bottom of the second nipple 21. The inner wall of the annular protrusion 1011 can be slidably connected to the outer wall of the third nipple 31.

[0072] With the above structural design, after the third nipple 31 comes into contact with the first nipple 101, the bottom and sides of the third nipple 31 will be sealed, so the sealing effect is significantly better.

[0073] See appendix Figure 14 and attached Figure 15 Since the second cylinder 2 is connected to the first cylinder 1, after the third cylinder 3 is removed from the second cylinder 2, the external environment can be indirectly connected to the first cylinder 1 through the second cylinder 2. The external environment contains various impurities such as dust, which makes the first cylinder 1 and the liquid inside the first cylinder 1 very easy to be contaminated. In order to solve the above problem, the following design is made in this embodiment. Specifically, it also includes a plug 10, which is detachably connected to the top of the second cylinder 2.

[0074] With the above structural design, after the third cylinder 3 is removed from the second cylinder 2, a plug 10 can be connected to the top of the second cylinder 2 for sealing, so that the interior of the first cylinder 1 and the second cylinder 2 can be kept clean.

[0075] It should be noted that this embodiment does not limit the material of the plug 10 or the method of detachable connection between the plug 10 and the second cylinder 2. Therefore, it can be flexibly designed according to actual needs. For example, the plug 10 can be made of rubber. In this case, the detachable connection between the plug 10 and the second cylinder 2 can be achieved by interference fit. Specifically, the diameter of the insertion part of the plug 10 should be slightly larger than the diameter of the inner wall of the top of the second cylinder 2. After the plug 10 is inserted into the second cylinder 2, the rubber plug 10 will spontaneously expand outward under its own elasticity, thereby forming a pressure seal and a damped plug-in detachable connection with the second cylinder 2.

[0076] To facilitate observation of the liquid separation process, the following design was implemented in this embodiment: Specifically, the first cylinder 1, the second cylinder 2, and the third cylinder 3 are all made of transparent material.

[0077] See appendix Figure 1 and attached Figure 10 Furthermore, the following design was also carried out in this embodiment: specifically, the first cylinder 1 and the third cylinder 3 are both provided with scale 11.

[0078] The design of the above structure allows for direct observation of the liquid volume, enabling more precise separation of a specified volume of liquid.

[0079] This invention also provides a method for preparing injectable concentrated growth factors. The method uses the above-mentioned separation device for injectable concentrated growth factors to prepare injectable concentrated growth factors. The preparation method includes the following steps: S1, blood collection; S2, differential centrifugation; S3, separation of concentrated growth factors.

[0080] Preferably, no anticoagulant is added during the blood collection process in step S1.

[0081] Preferably, the differential centrifugation procedure in step S2 is as follows: the collected blood is injected into the lower cavity of the first cylinder, and centrifuged at 10℃-20℃. The centrifugation is performed by physical acceleration for 24-30s, centrifugation at 610-650G for 100-140s, then deceleration to 460-510G for 220-240s, then acceleration to 630-680G for 200-240s, then acceleration to 700-750G for 160-200s, and finally deceleration for 35-40s before stopping.

[0082] Based on the above scheme, after centrifugation, the separation device for injectable concentrated growth factors is removed, and PPP in the upper layer, CGF in the middle layer, and RBC in the lower layer are obtained. The third nipple 31 is in a second state where it does not abut against the first nipple 101. The screw 41 is rotated and the first piston assembly 4 is moved upward, so that PPP in the lower cavity 103 enters the upper cavity 102 through the first nipple 101. Then, the upper cover 6 is moved downward, so that the third nipple 31 is in a first state where it abuts against the first nipple 101. Then, the first piston assembly 4 is moved upward, so that the target product CGF in the lower cavity 103 passes through the first nipple 101 and the third nipple 31 in sequence, and finally completely enters the interior of the third cylinder 3, thus obtaining concentrated growth factor CGF. At this time, the injection needle is connected to the third nipple 31 for injection.

[0083] Based on the above scheme, this embodiment introduces one method for preparing concentrated growth factors, specifically including the following steps:

[0084] Step 1: Draw 15-30 mL of peripheral blood from the blood using a sterile syringe without anticoagulant and inject it into the lower cavity 103 inside the first cylinder 1;

[0085] Step Two: Place the blood-injected separation device into a centrifuge equipped with a temperature control system. Then, simultaneously place an equal weight of balancing separation device into the centrifuge, ensuring the two devices are symmetrical. Begin differential centrifugation. The centrifugation temperature T should be 10-20℃, preferably 15℃. If the temperature is too high, blood clotting may occur during centrifugation; if the temperature is too low, the CGF will gel slowly in the body and may cause discomfort to the patient. Specific parameters for the differential centrifugation program are: First stage, acceleration time t1 = 24-30s, centrifugal force increases to 610-650G, centrifugation time t2 is 110-140s; specifically, t1 can be 24s, 25s, 28s, 30s, etc., and the centrifugal force can be 610-650G. The centrifugation force can be 0G, 624G, 636G, 642G, 650G, etc., and t2 can be 110s, 120s, 130s, 140s, etc., without specific limitations. The purpose of this stage of centrifugation is to cause blood cells to settle. Too rapid an ascent rate, too high a centrifugation speed, or too long a time will cause blood cells to rupture; conversely, blood cells cannot settle completely. In the second stage, the centrifugation force is adjusted to 460-510G, and the centrifugation time t3 is 220-240s. Specifically, the centrifugation force in this stage can be 460G, 466G, 475G, 484G, 497G, 503G, 510G, etc., and t3 can be 220s, 225s, 230s, 240s, etc., without specific limitations. In the third stage, the centrifugation force is adjusted to 63... The centrifugation force is 0-680G, and the centrifugation time t4 is 200-240s. Specifically, the centrifugal force in this stage can be 630G, 636G, 642G, 655G, 669G, 680G, etc., and t4 can be 200s, 210s, 220s, 230s, 240s, etc., without specific limitations. In the fourth stage, the centrifugal force increases to 700-750G, and the centrifugation time t5 is 160-200s. Specifically, the centrifugal force in this stage can be 700G, 705G, 718G, 734G, 742G, 750G, etc., and t5 can be 160s, 170s, 180s, 190s, 200s, etc., without specific limitations. The purpose of the changes in centrifugal force and centrifugation time in the second to fifth stages is... The process involves platelet aggregation in the intermediate layer, while physical acceleration and deceleration activate fibrinogen in the blood, inducing platelets to release growth factors. Excessive centrifugal force and prolonged centrifugation time may cause platelets to settle into the erythrocyte layer, while insufficient centrifugation may prevent sufficient aggregation. Excessive changes in centrifugal force can also lead to overactivation of fibrinogen, triggering coagulation. Conversely, slow changes in centrifugal force are not conducive to platelet and fibrin aggregation in the intermediate layer, resulting in low platelet activation and hindering growth factor release. In the fifth stage, the centrifugal force is reduced to 0, with a deceleration time t6 of 35-40 seconds. Specifically, t6 can be 35s, 36s, 37s, 38s, 39s, or 40s, without a specific limitation. The deceleration time in this stage affects the stability of the final centrifuged stratification.

[0086] Step 3: After centrifugation, the blood is separated into layers, and PPP (platelet-rich plasma) in the upper layer, CGF (concentrated growth factor) in the middle layer and RBC (red blood cells) in the lower layer are obtained. Carefully and steadily remove them from the centrifuge, and move the first piston assembly 4 upward so that the PPP in the lower chamber 103 enters the upper chamber 102 through the first nipple 101.

[0087] Step 4: Move the upper cover 6 downwards so that the third nipple 31 is in the first state of abutting the first nipple 101. Then move the first piston assembly 4 upwards so that the target product CGF in the lower cavity 103 passes through the first nipple 101 and the third nipple 31 in sequence and finally completely enters the interior of the third cylinder 3.

[0088] Step 5: Move the third cylinder 3 upward to separate the third cylinder 3 from the second cylinder 2, and then connect the injection needle, such as a No. 7 injection needle, at the third nipple 31 to obtain injectable CGF;

[0089] Step 6: Before injecting CGF, gently shake the third cylinder 3 to fully mix the CGF inside. Then, move the second piston assembly 5 upwards with the third nipple 31 facing upwards to expel the gas and excess CGF from the third cylinder 3. The specified volume of CGF can then be injected into the designated area through the injection needle.

[0090] The method described above for preparing CGF eliminates the need for anticoagulants, avoids adverse reactions, and does not inhibit fibrin network formation due to the presence of anticoagulants. It also more fully activates platelets to release growth factors. Furthermore, the third cylinder 3 can be directly removed for injection without the need to transfer CGF again, making the operation simpler and effectively preventing contamination of CGF during multiple transfers.

[0091] It should be noted that the target product CGF obtained through the above steps can maintain its injectability for 30-60 minutes under the temperature-controlled environment of a centrifuge, so it should be injected as soon as possible or stored in a timely manner.

[0092] Example 2

[0093] The difference between this embodiment and Embodiment 1 is that different centrifugation conditions are used; specifically, the experiment evaluates the effects of temperature and centrifugation program on the state and gelation rate of CGF after separation.

[0094] 20 mL of blood was drawn and injected into the above-mentioned injectable concentrated growth factor separation device. Centrifugation was performed using the centrifugation conditions in Table 1. The state of CGF after centrifugation was observed, and the time for injectable CGF to change from liquid to gel state at 37°C was calculated. The experimental results are shown in Table 2.

[0095] Table 1 is as follows:

[0096]

[0097]

[0098] Table 2 is as follows:

[0099]

[0100] Example 3

[0101] The difference between this embodiment and Embodiment 1 is that an experimental study was conducted on the sustained release of growth factors by injectable CGF under physiological conditions. The specific experimental procedure is as follows:

[0102] Thirty-six volunteers were recruited, and 26 mL of autologous blood was collected from each. 20 mL of blood was used to separate 3 mL of CGF using the preparation method and separation device provided in this invention, and the remaining 6 mL of blood was used to prepare 3 mL of plasma. 3 mL of CGF and 3 mL of plasma were added to 10 mL of serum-free DMEM medium and incubated at 37°C. Every 24 hours, 200 mL of the supernatant was collected, and 200 mL of fresh medium was added. Sampling continued for 12 days. The levels of TGF-β, PDGF, and VEGF released from CGF and plasma into the culture medium were detected using an ELISA kit, and the average values ​​were used to plot the concentration curves of these growth factors over time. These three growth factors have functions in promoting cell proliferation and differentiation, regulating inflammation, and promoting angiogenesis in clinical tissue repair, playing a crucial role in tissue repair and reconstruction.

[0103] Experimental results are as follows Figure 16 As shown, the three growth factors TGF-β, PDGF and VEGF in CGF exhibited sustained-release behavior within 12 days, with concentrations all higher than those in plasma and without significant decrease. This indicates that CGF can slowly release growth factors in the physiological environment and maintain growth factor activity for a longer period of time, giving it advantages in long-term tissue reconstruction applications such as bone repair and articular cartilage treatment.

[0104] It should be noted that the terminology used herein is for the purpose of describing particular embodiments only and is not intended to limit the exemplary embodiments according to this application. As used herein, the singular form is intended to include the plural form as well, unless the context clearly indicates otherwise. Furthermore, it should be understood that when the terms "comprising" and / or "including" are used in this specification, they indicate the presence of features, steps, operations, devices, components, and / or combinations thereof.

[0105] Furthermore, it should be noted that the use of terms such as "first" and "second" to define components is merely for the purpose of distinguishing the corresponding components. Unless otherwise stated, the above terms have no special meaning and therefore cannot be construed as limiting the scope of protection of this application.

[0106] Although embodiments of the present invention have been shown and described, it will be understood by those skilled in the art that various changes, modifications, substitutions and alterations can be made to these embodiments without departing from the principles and spirit of the present invention, the scope of which is defined by the appended claims and their equivalents.

Claims

1. An isolated device for injectable concentrated growth factors, characterized in that, The utility model relates to a kind of injection device, including: First cylinder, the first cylinder is arranged through up and down, the inside of the first cylinder is equipped with the first nipple that protrudes upwards, the first nipple can divide the inside of the first cylinder into upper cavity located above and lower cavity located below, the top of the first cylinder is detachably connected with upper cover body for sealing, the bottom of the first cylinder is detachably connected with lower cover body for sealing; Second cylinder, the second cylinder is fixedly connected in the bottom of the upper cover body and is arranged through up and down, the bottom of the second cylinder is equipped with the second nipple that protrudes downwards and corresponds the first nipple, the second nipple and the first nipple have spacing, the spacing can be reduced by moving the upper cover body downwards; Third cylinder, the third cylinder is connected in the inside of the second cylinder and is arranged through up and down, the bottom of the third cylinder is equipped with the third nipple that protrudes downwards and corresponds the first nipple, the outer wall of the third nipple is slidably connected with the inner wall of the second nipple, the third nipple has the first state of abutting the first nipple and the second state of not abutting the first nipple, when the third nipple is in the first state, the third cylinder and the lower cavity are communicated, when the third nipple is in the second state, the third cylinder and the upper cavity are communicated, the second state is initial state, moving the upper cover body downwards can make the second cylinder drive the third cylinder to move downwards, so that the third nipple changes to the first state; First piston assembly, the first piston assembly is slidably connected in the inside of the lower cavity, can be close to or away from the first nipple; Second piston assembly, the second piston assembly is slidably connected in the inside of the third cylinder, can be close to or away from the third nipple.

2. The injectable growth factor concentrate separation device of claim 1, wherein, The first piston assembly includes: Screw rod, the screw rod is vertically arranged and is threadedly connected in the middle of the lower cover body, the screw rod has first end and second end away from each other, the first end is located in the inside of the first cylinder, and the second end is located outside the first cylinder; Support, the support is made of rigid material, the bottom of the support is connected with the first end of the screw rod, so that the support can move up and down with the rotation of the screw rod; First plug body, the first plug body is made of flexible material, the bottom of the first plug body is detachably connected with the top of the support, for fixing the relative position of the first plug body and the support, the side of the first plug body is slidably connected with the inner wall of the first cylinder, to prevent the liquid in the lower cavity from leaking from below.

3. The injectable growth factor concentrate isolation device of claim 2, wherein, Injection hole is arranged on the support, one end of the injection hole abuts against the first plug body, and the other end opposite thereto is arranged in position with the screw rod.

4. The injectable growth factor concentrate separation device of claim 1, wherein, The second piston assembly includes: Core rod, the core rod is vertically arranged and is slidably connected with the inner wall of the third cylinder, the core rod has driving end and driven end away from each other, the driving end is located outside the third cylinder, and the driven end is located in the inside of the third cylinder; A second plug body made of flexible material, a top of the second plug body being detachably connected to a driven end of the core rod for fixing relative positions of the second plug body and the core rod, a side of the second plug body being sealingly and slidingly connected to an inner wall of the third barrel body to prevent liquid in the third barrel body from leaking from above.

5. The injectable growth factor concentrate separation device of claim 1, wherein, The upper cover body is provided with a first hole, the first hole being communicated with the upper cavity and the outside, a gas permeable diaphragm being placed at the first hole and being fixed by a fixing plug, the fixing plug being provided with a gas permeable hole corresponding to the position of the first hole, so that the gas in the upper cavity and the outside gas can be exchanged through the gas permeable diaphragm, and the gas passing through the gas permeable diaphragm is filtered, so that the gas pressure in the upper cavity and the outside gas pressure can be kept consistent, and the gas in the upper cavity and the outside gas can be prevented from being polluted.

6. The injectable growth factor concentrate isolation device of claim 1, wherein, The upper cover body is provided with a second hole, the second hole being communicated with the upper cavity and the outside, for inputting fluid into the upper cavity or extracting fluid in the upper cavity, a sealing plug being detachably connected at the second hole for sealing.

7. The injectable growth factor concentrate isolation device of claim 1, wherein, A top of the first nipple is provided with an annular protrusion, a top of the annular protrusion and a bottom of the second nipple having a spacing, an inner wall of the annular protrusion being slidingly connected with an outer wall of the third nipple, for enhancing the sealing degree when the third nipple is in the first state.

8. The injectable growth factor concentrate isolation device of claim 1, wherein, A plug is further included, the plug being detachably connected with a top of the second barrel body, for sealing the second barrel body after the third barrel body is taken out.

9. An injectable growth factor concentrate isolation device according to any one of claims 1-8, wherein, The first barrel body, the second barrel body and the third barrel body are all made of transparent material, so as to facilitate observation of the liquid separation process.

10. The injectable growth factor concentrate isolation device of claim 9, wherein, The first barrel body and the third barrel body are both provided with scales, for observing the volume of the liquid.

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