Platelet-rich plasma preparation device, preparation method and application thereof

Abstract

This invention discloses a platelet-rich plasma (PRP) preparation device, its preparation method, and its applications. The device comprises integrated sterile components for the entire process of blood collection, centrifugation, transfer, and recombination. Through an optimized secondary centrifugation process, it can stably and efficiently separate and enrich platelets from autologous whole blood, thereby preparing PRP that meets clinical requirements. The device features a rationally designed component structure and a standardized and simple operating procedure, effectively controlling unnecessary platelet activation during the preparation process and ensuring the bioactivity and release potential of growth factors in the PRP. Experimental results show that the growth factor enrichment efficiency and platelet activation level of the PRP obtained using this device are comparable to mainstream commercially available products, with superior ease of operation and standardization. This product provides a reliable and efficient PRP preparation tool for clinical use, particularly suitable for adjunctive treatment of trauma repair such as fracture surgery.

Description

Technical Field

[0001] This invention belongs to the field of medical device technology, specifically relating to a medical device for preparing autologous platelet-rich plasma (PRP) from human autologous blood samples, and in particular a platelet-rich plasma preparer with reasonable structure, simple operation and stable enrichment efficiency, which is suitable for the efficient and safe preparation of PRP in the adjuvant treatment of clinical fracture surgery. Background Technology

[0002] Platelet-rich plasma (PRP) is a plasma component rich in platelets, separated from whole blood through centrifugation. It contains various growth factors, such as platelet-derived growth factor (PDGF), vascular endothelial growth factor (VEGF), and transforming growth factor (TGF), which play important bioactive roles in tissue repair, wound healing, and bone regeneration. Currently, PRP is widely used in various clinical fields, including orthopedics, dentistry, and plastic surgery.

[0003] Existing PRP preparation devices mostly employ a two-stage centrifugation method, using different centrifuge tubes, syringes, and related components to achieve platelet separation and enrichment. However, PRP preparation devices from different manufacturers vary in component design, operating procedures, enrichment efficiency, and platelet activation control, resulting in inconsistencies in the growth factor concentration, platelet recovery rate, and activation state of the prepared PRP, thus affecting its standardized application in clinical practice.

[0004] Furthermore, some existing PRP preparers suffer from problems such as excessive platelet activation, high levels of residual red and white blood cells, and complex preparation processes, which hinder the rapid, safe, and efficient acquisition of PRP products that meet therapeutic requirements in clinical practice. Therefore, there is an urgent need to develop a PRP preparer with a rational structure, simple operation, stable enrichment effects, and performance comparable to existing marketed products to meet the clinical demand for high-quality PRP preparation tools.

[0005] The platelet-rich plasma (PRP) preparation device provided by this invention achieves efficient enrichment and gentle processing of platelets through optimized component structure and standardized preparation process, ensuring effective concentration and appropriate activation levels of growth factors in PRP. Currently, no similar products with the exact same structure and clinical applicability have been reported. Summary of the Invention

[0006] The purpose of this invention is to provide a platelet-rich plasma preparation device, which has the characteristics of reasonable structure, simple operation, high enrichment efficiency, and controllable platelet activation, and can stably prepare autologous platelet-rich plasma that meets the requirements for clinical use.

[0007] Another objective of this invention is to provide a method for using the aforementioned platelet-rich plasma preparation device, which has clear steps, a high degree of standardization, and is easy for clinical medical personnel to operate.

[0008] Another object of the present invention is to provide the application of the above-described preparation apparatus in the preparation of autologous platelet-rich plasma for adjuvant treatment of fracture surgery.

[0009] To achieve the above objectives, the present invention adopts the following technical solution: A platelet-rich plasma (PRP) preparation device includes a blood collection assembly, a centrifuge tube assembly, a syringe assembly, an auxiliary connection assembly, and a packaging container. The blood collection assembly includes a blood collection needle and an anticoagulant blood collection tube. The centrifuge tube assembly includes dedicated centrifuge tubes for primary and secondary centrifugation. The syringe assembly includes syringes of different sizes for plasma transfer and recombination. The auxiliary connection assembly includes a needle holder, a drug dispensing needle, and a conversion connector. All components are sterile and individually packaged, and can be used directly in a clinical setting.

[0010] This invention also provides a method of using the platelet-rich plasma generator, comprising the following steps: (1) Blood collection and anticoagulation treatment: Use a blood collection needle to collect venous blood from the patient, inject it into a blood collection tube containing anticoagulant, and mix gently to prevent clotting; (2) Single centrifugation: Transfer the anticoagulated whole blood to a single centrifuge tube and centrifuge at the specified centrifugal force to separate the red blood cells and plasma layer; (3) Plasma transfer: Use a syringe to draw up the upper plasma layer and transfer it to a secondary centrifuge tube; (4) Second centrifugation: The plasma is centrifuged twice to precipitate platelets; (5) Recombination and activation: Remove part of the supernatant, retain the platelet precipitate, and recombine it into PRP using a syringe; PRP can be activated with an activator as needed clinically.

[0011] Preferably, the anticoagulant is a sodium citrate solution.

[0012] Preferably, the first centrifugation conditions are: centrifugal force 700g, time 10 minutes; the second centrifugation conditions are: centrifugal force 850g, time 10 minutes.

[0013] Preferably, the PRP can be used in combination with bone repair materials to enhance the bone repair effect.

[0014] The present invention also provides the application of the platelet-rich plasma preparer in preparing autologous platelet-rich plasma from human autologous blood samples.

[0015] Compared with the prior art, the beneficial effects of the present invention are as follows: 1) The platelet-rich plasma (PRP) preparation device provided by this invention has rationally configured and integrated components, covering all sterile equipment required for the entire process from blood collection and centrifugation to PRP recombination. The components are seamlessly connected, and the operation process is clear and unambiguous, significantly reducing the complexity of clinical use. This facilitates medical staff to quickly master and standardize the preparation process, reducing the impact of human operational differences on PRP quality.

[0016] 2) Through standardized secondary centrifugation process and supporting components, the preparation device of this invention can stably and efficiently enrich platelets from autologous whole blood, possessing the same effective enrichment capacity as mature products, thus ensuring the basic therapeutic activity of PRP.

[0017] 3) The material selection and process design of this preparation device emphasize the gentle handling of platelets. The preparation process effectively avoids excessive or unnecessary activation of platelets, which helps maintain the resting state of platelets and their targeted activation and release at the treatment site, thereby better ensuring the expected biological efficacy of PRP.

[0018] 4) The preparation device of this invention has wide applicability and excellent material compatibility, which enables it to flexibly adapt to diverse clinical scenarios and treatment plan requirements, providing a reliable and consistent source of PRP products for treatments such as fracture repair. Attached Figure Description

[0019] Figure 1 This is a comparison chart of growth factor concentrations in PRP prepared by the apparatus of this invention and the control product.

[0020] Figure 2 This is a comparison chart of the growth factor concentrations after PRP activation prepared by the apparatus of this invention and the control product.

[0021] Figure 3 This is a comparison chart of the expression levels of platelet activation markers PAC-1 and CD62p in PRP prepared by the apparatus of this invention and the control product. Detailed Implementation

[0022] The platelet-rich plasma (PRP) generator and its preparation method provided by the present invention will be further described below with reference to embodiments, but the following embodiments should not be regarded as a limitation on the scope of protection of the present invention.

[0023] Example 1: Structural composition of a platelet-rich plasma (PRP) generator The YN-PRPN-I specification includes 3 blood collection tubes, 2 x 5 mL syringes, 1 x 1 mL syringe, 1 needle holder, 1 needle holder (with puncture needle), 3 injection needles (0.3 mm × 25 mm, 1 x 0.4 mm × 13 mm, 1 x 1.2 mm × 38 mm), 1 medication preparation needle, and 1 blood collection needle.

[0024] Example 2: Preparation method of platelet-rich plasma The platelet-rich plasma (PRP) preparer of Example 1 was selected for subsequent comparative experiments. Venous blood was collected from healthy volunteers and injected into blood collection tubes containing sodium citrate anticoagulant, then gently mixed. The anticoagulated whole blood was transferred to a primary centrifuge tube and centrifuged at 700g for 10 minutes. The supernatant was transferred to a secondary centrifuge tube and centrifuged again at 850g for 10 minutes. Part of the supernatant was removed, retaining the platelet precipitate, which was gently resuspended using a syringe to obtain platelet-rich plasma (PRP). PRP was prepared using the preparer of this invention and a control product, respectively. The concentrations of growth factors (PDGF-BB, VEGF, TGF-β1) after centrifugation and activation were measured, and enrichment performance and other characteristics were analyzed.

[0025] To verify the practical application effect of the preparation device of the present invention, PRP was prepared using the preparation device of the present invention and a commercially available control product, and the system performance was compared and tested. The relevant test data are as follows: Experimental Example 1: Comparative Analysis of PRP Growth Factor Enrichment Effect Using the method described in Example 2, PRP samples were prepared from 12 volunteers using the apparatus of this invention and the control product, respectively. The concentrations of three key growth factors (PDGF-BB, VEGF, TGF-β1) in the centrifuged PRP were detected by enzyme-linked immunosorbent assay (ELISA), and the concentration factor was calculated by comparing them with the initial concentration in whole blood. The results are as follows: Figure 1 As shown, the PRP prepared by the apparatus of this invention had concentration folds of PDGF-BB, VEGF, and TGF-β1 of (1.17±0.13), (1.73±0.49), and (1.52±0.32), respectively. Compared with the control group [(1.21±0.13), (1.75±0.56), (1.69±0.49)], there were no statistically significant differences (P>0.05). This indicates that the apparatus of this invention achieves the same level of enrichment efficiency of core growth factors as mainstream products already on the market.

[0026] Experimental Example 2: Evaluation of PRP growth factor release capacity after activation The PRP prepared in Example 1 was activated, and the concentrations of PDGF-BB, VEGF, and TGF-β1 in the supernatant after activation were detected by ELISA, and the concentration factor after activation was calculated. The concentration factors of PDGF-BB, VEGF, and TGF-β1 in the prepared PRP group after activation were (2.93±0.82), (10.02±1.67), and (4.08±0.94), respectively, which were not significantly different from the control group [(3.09±1.06), (10.19±2.22), (4.05±1.09)] (P>0.05). This result demonstrates that the PRP obtained by the prepared PRP of this invention has a normal and sufficient growth factor release capacity after platelet activation, which can meet the biological activity required for clinical treatment.

[0027] Experimental Example 3: Platelet Activation Control Level Test During Preparation To assess the impact of the preparation process on platelet preactivation, the expression levels of platelet activation markers PAC-1 (characterizing fibrinogen receptor exposure) and CD62p (P-selectin, characterizing α-granule release) were measured in PRP prepared by the apparatus of this invention and the control product, respectively, without exogenous activation. The concentrations of PAC-1 and CD62p in the PRP prepared by the apparatus of this invention were (28.13±7.97) ng / mL and (23.92±7.08) ng / mL, respectively, which showed no statistically significant difference compared to the control group [(27.17±8.89) ng / mL and (23.72±6.88) ng / mL] (P>0.05). This indicates that the apparatus of this invention can effectively control unnecessary platelet activation during the preparation process, achieving levels comparable to the control product, which is beneficial for maintaining the resting state of platelets in PRP and ensuring timely and appropriate activation at the treatment site.

[0028] This invention successfully developed a structurally optimized, easy-to-operate, and stable platelet-rich plasma (PRP) preparation device and its standardized preparation method. Through integrated and sterile component design, the device achieves a closed-loop operation from blood collection to PRP recombination, effectively reducing the complexity and contamination risk in clinical use. Its standardized secondary centrifugation process stably and efficiently enriches platelets and effectively controls the pre-activation level of platelets during preparation, ensuring the effective concentration and bioactivity of growth factors in the obtained PRP. Comparative experiments show that this device achieves the same performance as mainstream marketed products in key performance indicators, while exhibiting superior ease of operation and process standardization. This product provides clinicians with a reliable and efficient tool for preparing autologous platelet-rich plasma, particularly suitable for adjuvant therapies such as fracture repair, and has clear clinical application value and market prospects.

[0029] The above embodiments are merely preferred embodiments of the present invention, and the scope of protection of the present invention is not limited thereto. Any improvements and modifications made by those skilled in the art within the scope of the technical principles disclosed in the present invention should be included within the scope of protection of the present invention.

Claims

1. A method of using a platelet-rich plasma (PRP) generator, characterized in that, The method includes the following steps: (1) Blood collection and anticoagulation treatment: Collect venous blood using a blood collection needle, inject it into a blood collection tube containing anticoagulant, and mix well; (2) Single centrifugation: Transfer the anticoagulated whole blood to a single centrifuge tube and centrifuge at the specified centrifugal force to separate the red blood cells from the plasma layer; (3) Plasma transfer: Use a syringe to draw up the supernatant plasma and transfer it to a secondary centrifuge tube; (4) Secondary centrifugation: The plasma is centrifuged twice to precipitate platelets; (5) Recombination: Remove part of the supernatant, retain the platelet precipitate, and recombine it into platelet-rich plasma using a syringe.

2. The method of use according to claim 1, characterized in that, The anticoagulant is a sodium citrate solution.

3. The method of use according to claim 1, characterized in that, The conditions for the first centrifugation were: centrifugal force 700g, time 10 minutes.

4. The method of use according to claim 1, characterized in that, The conditions for the secondary centrifugation are: centrifugal force 850g, time 10 minutes.

5. A platelet-rich plasma preparation device, characterized in that, The apparatus includes components for carrying out the method according to any one of claims 1-4, the components including a blood collection assembly, a centrifuge tube assembly, and a syringe assembly.

6. The platelet-rich plasma preparation device according to claim 5, characterized in that, The blood collection assembly includes a blood collection needle and a blood collection tube containing an anticoagulant; the centrifuge tube assembly includes dedicated centrifuge tubes for primary and secondary centrifugation; and the syringe assembly includes syringes of different sizes for plasma transfer and recombination.

7. The platelet-rich plasma preparation device according to claim 5, characterized in that, The preparation device also includes auxiliary connection components, which include one or more of a needle holder, a dispensing needle, and an adapter.

8. The platelet-rich plasma preparation device according to claim 5, characterized in that, All components of the preparer are sterile and individually packaged.

9. The platelet-rich plasma preparation device according to claim 5, characterized in that, The preparation device is model YN-PRPN-I, which includes: 3 blood collection tubes, 2 five-mL syringes, 1 one-mL syringe, 1 needle holder, 1 needle holder with puncture needle, 3 injection needles of 0.3 mm × 25 mm, 1 needle of 0.4 mm × 13 mm, and 1 needle of 1.2 mm × 38 mm; 1 drug preparation needle; and 1 blood collection needle.

10. The use of a platelet-rich plasma preparer as described in any one of claims 5-9 in the preparation of autologous platelet-rich plasma for adjuvant treatment of fracture surgery.

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