Adaptable device and process for obtaining concentrated platelet volume by double centrifugation of peripheral blood.

Abstract

This patent application (PI) relates to an adaptable device and process for obtaining a concentrated volume of platelets by double centrifugation. As a distinguishing feature, the process and device, disclosed and claimed herein, allow the collection device to be the same as that used for centrifugation, which reduces the chance of premature platelet activation, thus increasing the effectiveness of the technique. In addition to the aforementioned advantage, among others, the device is made of inert material, preventing adhesion to the wall and platelet degradation. The said device and process developed are specifically and preferably applicable to the fields of sports medicine, orthopedics, dermatology, dentistry, and other related areas, and can directly contribute to tissue repair resulting from various pathologies.The said device comprises the following components: a plunger adaptable to the syringe (1), a blind-end rod (2), a blind-end cap (3), a stopper (4) and a long stopper (5), while the obtaining of the concentrated platelet volume, comprised of platelet-rich plasma (PRP), is obtained by double centrifugation involving steps (a), (b), (c), (d), (e) and (f).

Description

1 / 16 Adaptable device and process for obtaining concentrated platelet volume by double centrifugation of peripheral blood. BRIEF PRESENTATION

[001] This invention patent (PI) relates to an adaptable device and process for centrifuging peripheral blood to obtain a concentrated volume of platelets with healing activity, through growth factors contained in the platelets, aiming at its application in sports medicine, orthopedics, dermatology, dentistry and other related areas. As a differentiating characteristic, the process and device, disclosed and claimed herein, allows the collection device to be the same as that used for centrifugation, which reduces the chance of premature platelet activation, thus increasing the effectiveness of the technique. In addition to the aforementioned advantage, among others, the device is made of inert material, preventing adhesion to the wall and platelet degradation processes.

[002] More specifically, it is highlighted that the present invention relates to the development of an 'ADAPTABLE DEVICE AND PROCESS FOR OBTAINING CONCENTRATED PLATELET VOLUME BY DOUBLE CENTRIFUGATION OF PERIPHERAL BLOOD', characterized by being an effective process and / or technique for obtaining concentrated platelet volume, since it involves the preferential performance of two centrifugation steps, increasing the effectiveness of the process for obtaining concentrated platelet volume.

[003] It is further emphasized that, in relation to the existing problem in the state of the art, the lack of techniques and / or methods and / or processes in which the collection device is the same as that used for centrifugation stands out, which reduces the chance of premature platelet activation, also contributing to increasing the effectiveness of said process. In addition, Petition 870170080113, dated 10 / 20 / 2017, page 17 / 43 2 / 16 It is noteworthy that there are no available processes and / or techniques that allow for a cost-benefit ratio similar to that presented in this patent application, since the process does not involve the application of complex and / or sophisticated technologies. The characteristics presented guarantee the differentiated and advantageous nature of the present invention, as well as the inventive activity related to the inventive concept presented and claimed herein, when specifically compared to other types of techniques / reactions / processes / methods for obtaining concentrated platelet volume.

[004] Thus, this invention patent document discloses all the characteristics of said device, which comprises adaptable parts, as well as said process for obtaining a concentrated volume of platelets by means of double centrifugation of peripheral blood, with cicatricial activity, by means of growth factors contained in the platelets. In addition, all the steps inherent to the claimed process are disclosed in detail, identifying and revealing in detail all the mechanisms for obtaining a concentrated volume of platelets. FIELD OF APPLICATION

[005] The present invention relates to a device with adaptable parts and a process for obtaining a concentrated volume of platelets through double centrifugation of peripheral blood, with healing activity, by means of growth factors contained in the platelets. Said device and process developed are specifically and preferably applicable in the fields of sports medicine, orthopedics, dermatology, dentistry and other related areas, and can directly contribute to tissue repair resulting from various pathologies. FUNDAMENTALS OF THE TECHNIQUE Petition 870170080113, dated 10 / 20 / 2017, page 18 / 43 3 / 16

[006] Various materials have been developed to promote the induction of bone growth factors or osteoinduction, stimulating osteoblastic activity in injured bone. Platelet-rich plasma (PRP) has proven effective in this process of tissue regeneration and healing, especially bone tissue [SANTOS, BA - Platelet-rich plasma: truths and controversies - Doctoral Thesis, 2009].

[007] PRP has been used in plastic and maxillofacial surgery for over a decade. Currently, it is increasingly being used in orthopedics and sports medicine for the treatment of tendinopathies, muscle fibrosis, shoulder injuries, meniscus and articular cartilage injuries [CERZA, F. et al. Comparison between hyaluronic acid and platelet-rich plasma infiltration in the treatment of gonarthrosis - American Journal of Sports Medicine, 2012].

[008] PRP is prepared from a small amount of blood, taken from the patient and obtained by centrifugation [SANTOS, BA - Platelet-rich plasma: truths and controversies. - Doctoral Thesis, 2009]. This cell separation aims to obtain plasma with a higher concentration of platelets compared to the baseline count of peripheral blood. This higher concentration of platelets results in a greater supply of growth factors, which may induce faster bone regeneration [MACEDO, AP - Platelet-rich plasma: a quantitative and qualitative analysis of two obtaining protocols. - Master's Dissertation, 2004; GARCIA, RLL et al. - Platelet-Rich Plasma: a literature review. Brazilian Journal of Implantology & Prosthetics, 2005].

[009] The combined action of growth factors results in signaling for mesenchymal and epithelial cells to migrate to the injured site, undergo mitotic division, stimulate matrix and collagen synthesis, thus resulting in faster and more efficient healing. In addition, other platelet proteins such as fibrin, fibronectin and vitronectin act by promoting cell adhesion and osteoconduction [DUSSE, LMS; MACEDO, AP; BATSCHAUER, A. Petition 870170080113, dated 10 / 20 / 2017, page 19 / 43 4 / 16 P.; CARVALHO, MG - Platelet-rich plasma (PRP) and its application in dentistry. - Brazilian Journal of Clinical Analysis, 2008].

[010] The use of PRP has the advantage of being derived from the patient's own body (autologous), which reduces the risk of transmission of infectious diseases, is not toxic or capable of generating an immune reaction, and has a low incidence of side effects, only about 2% to 5%. Most reported effects are sensitivity, swelling and local pain [FILARDO, G.; KON, E.; ROFFI, A.; DI MATTEO, B.; MERLI, ML; MARCACCI, M. - Platelet-rich plasma: why intraarticular? A systematic review of preclinical studies and clinical evidence on PRP for joint degeneration. - Knee surgery, sports traumatology, arthroscopy: official journal of the ESSKA, 2015; GARCIA, RLL et al. - Platelet-Rich Plasma: a literature review. - Brazilian Journal of Implantology & Prosthetics, 2005; MORAES, VY, LENZA, M., TAMAOKI, MJ, FALOPPA, F., BELLOTI, JC Platelet-rich therapies for musculoskeletal soft tissue injuries. - Cochrane Database of Systematic Reviews, 2014).

[011] Within this context, and given the need to develop new methods and / or processes and / or techniques and / or specific reactions for obtaining concentrated platelet volumes in an effective, safe and economical way, the present invention aims to disclose in detail a device with adaptable parts and the process for obtaining a concentrated platelet volume through double centrifugation of peripheral blood, with healing activity, through growth factors contained in the platelets, responsible for stimulating tissue repair, aiming at its application in sports medicine, orthopedics, dermatology, dentistry and other related areas. It is important to highlight as a problem of the state of the art the lack of a method and / or processes and / or techniques and / or specific reactions with the characteristics described in this patent application, that is, that presents the advantages described herein. SPECIALIZED TECHNICAL LITERATURE Petition 870170080113, dated 10 / 20 / 2017, page 20 / 43 5 / 16

[012] The scientific literature presents several studies conducted in search of techniques for obtaining concentrated platelet volumes, such as a study that revealed a method described as economical for platelet concentration [FUKAYA, M.; ITO, A. - A new economic method for preparing platelet-rich plasma - PRS Global Open, 2014]. However, this method involves the manipulation of plasma material, with repeated transfers from one syringe to another using thin, long scalpels, aspects that can result in premature and undesirable platelet activation.

[013] Several techniques / processes for obtaining PRP are available in the state of the art, such as the Biomet System GPS II technique, which allows obtaining PRP without the risk of samples being contaminated by excessive handling. Using this technique, blood is collected and transported to a GPS II tube and centrifuged for 15 minutes at a speed of 3200 rpm. After this process, the platelet-poor plasma is removed. The system is agitated for 30 seconds to resuspend the cloud zone. Immediately afterwards, the PRP is collected. This is a complex method and only one centrifugation is performed, however, one centrifugation does not produce PRP, but a mixture of platelet-poor plasma (PPP) and PRP, which results in a low total platelet concentration [MACEDO, AP - Platelet-rich plasma: a quantitative and qualitative analysis of two obtaining protocols. Master's Dissertation, 2004; PEREIRA, RCF - Evaluation of seven protocols for obtaining platelet-rich plasma (PRP).- Master's Thesis, 2012). In contrast, the invention presented here in this patent document allows for obtaining PRP at lower costs and in a low-tech environment.

[014] Another method currently available on the market, Genesis CS®, has a kit with two sterile tubes. The collected blood is transferred to these tubes and centrifuged. After that, the plasma is collected through a closed system, which minimizes the risk of contamination, by Petition 870170080113, dated 10 / 20 / 2017, page 21 / 43 6 / 16 On the other hand, this method allows for a higher concentration of red blood cells, resulting in greater difficulty in activating platelets in PRP.

[015] The specialized technical literature reveals some patent documents that refer to some techniques / processes, automatic, semi-automatic and manual devices for obtaining platelet concentrate, which present some disadvantages and do not violate the novelty and inventive step requirement of the invention proposed here. To support the criteria of novelty and inventive step, a search was conducted in the patent database of the National Institute of Industrial Property (INPI), which compiles the collection of patents filed in Brazil, and in the European Patents database (Espacenet), which compiles the collection of patents filed in more than 90 countries. The search did not identify any patent document that refers to an adjustable device and double centrifugation process of peripheral blood for obtaining a concentrated volume of platelets that presents characteristics similar to those of this application.

[021] The most relevant documents will be described below, however, it is important to make it clear that none of them violate the novelty and inventive step requirements of the invention patent requested in this document.

[022] US patent document US6558307 describes a method for collecting platelets suspended in plasma from whole blood. The blood is centrifuged at a sufficiently high rotational speed, and the platelets are separated from the plasma and red blood cells. A portion of the plasma is removed while the centrifuge rotates to keep the platelets separate from the plasma. Then, the rotational speed is altered so that the platelets mix with the remaining plasma. The aforementioned method uses only one centrifugation step, differing from the invention proposed here, which performs two centrifugations, resulting in a concentrate with a higher number of platelets, making the technique more effective. Thus, the Petition 870170080113, dated 10 / 20 / 2017, page 22 / 43 7 / 16 The technology required and claimed herein is considerably distinct from that requested in this invention patent document, and therefore cannot be considered as limiting the request for exclusivity of what is proposed in this patent document, nor as limiting the inventive activity.

[023] US patent document US5494578 describes a blood component separation system comprising a centrifuge and a disposable, single-use assembly comprising a flexible separation chamber, which has an inlet port, a separated component outlet port, and a residual fluid outlet port. The separation chamber is positioned in the annular slot and rotated at a predetermined rotational speed. Fluids such as whole blood flow through the separation chamber and are separated into various therapeutic components such as platelet-rich plasma and concentrated residual red blood cells. Platelet-rich plasma can be withdrawn as the separated therapeutic component. PRP is separated from red blood cells in a first part. Platelet-rich plasma flows to the second part and is separated into platelet-poor plasma and platelets. Platelet-poor plasma can be withdrawn and returned to the donor.Although it describes a method for obtaining PRP, the technique and method described in the aforementioned patent document differ considerably from what is requested in this application, and therefore, this document cannot be considered limiting, that is, a document of the prior art that interferes with the exclusive right of what is requested in this patent.

[024] Patent document EP2910258 aims to describe a PRP separator and concentrator, comprising an enclosure, a separation assembly, and a concentration assembly. The separation assembly is connected to and positioned above the concentration assembly. The separation assembly includes a filter-lined separation chamber with pores sized to receive and retain erythrocytes during the Petition 870170080113, dated 10 / 20 / 2017, p. 23 / 43 8 / 16 Centrifugation. The concentration compartment has a support floor for desiccated granules and a wall with at least one opening closed with a screen. Concentrated PRP is produced by contacting PRP with desiccated granules. Rotation of the concentration compartment at specific speeds serves to separate the concentrated PRP from the granules. It should be noted that the invention described does not reveal the scope of protection being sought in this patent application and therefore cannot be considered a limiting document of the state of the art.

[025] US patent document US2006017524 also describes a PRP separator-concentrator, comprising a motorized centrifugal separation assembly, and a concentrator assembly. The separator assembly comprises a centrifugal separator that includes an erythrocyte capture module and a motor with a drive shaft connected to the separator drum. The concentrator assembly comprises a water removal module for the preparation of PRP concentrate. The water removal module may be a syringe device with water absorption granules. Although the application refers to a PRP obtaining device, it cannot under any circumstances be considered as limiting the state of the art since its mechanism differs considerably from what is sought for protection in this patent document.

[026] Among the equipment available on the market for obtaining PRP, the MK-Ortho Proteal® is the one that most closely resembles the invention proposed here. However, because it has three stages, it is a method that requires more time to concentrate platelets, presenting a greater risk of cellular degradation. In addition to reducing one stage, making the process faster, the invention proposed here involves performing two centrifugations, increasing the platelet concentration in the final product.

[027] With regard to patented technologies available in the state of the art, there are other systems, such as RegenKit® PRP, Cytomedix Angel® and Harvest Smart PReP® 2, however, all of them have Petition 870170080113, dated 10 / 20 / 2017, page 24 / 43 9 / 16 inventive concepts completely different from the invention proposed in this patent document, and therefore, should not be considered as limiting products of the state of the art.

[028] The RegenKit® PRP system describes a method with only one centrifugation step, which makes preparation faster, however, less effective when compared to the process proposed here. Unlike RegenKit® PRP, the invention proposed here involves two centrifugations in its process, increasing the effectiveness of the technique since it increases the platelet concentration in the final product.

[029] The Cytomedix Angel® method uses a specific centrifuge with a three-compartment reservoir bag attached to store blood-derived products (whole blood, red blood cells, and platelet-poor plasma). A syringe is provided to collect the platelet-rich plasma. Despite the low risk of contamination, it requires specialized and expensive materials. The invention proposed here is easy to apply and eliminates the need for complex and sophisticated technology, reducing the cost of the process. Furthermore, the material developed for the invention proposed here is inert, preventing adhesion to the platelet wall and platelet degradation.

[030] Finally, the Harvest Smart PReP® 2 suggests collecting blood using a syringe and transferring it to a unique and specific device that is connected only to a particular centrifuge, which increases the cost. It is a method with a low risk of contamination, however, it is a laborious method and requires learning on the part of the person who will perform the procedure. Due to this, it is more subject to errors in preparation, compromising the quality of the product. The invention proposed in this patent document uses simpler equipment, allowing the preparation of PRP at a lower cost. In addition, it is an easily reproducible method.

[031] Thus, the development and use of the product and process proposed in this invention patent document has the parameter of Petition 870170080113, dated 10 / 20 / 2017, page 25 / 43 10 / 16 novelty, since to date no scientific or technical work within the state of the art possesses a similar production, operation and application mechanism, which can be used to obtain concentrated platelet volumes in an efficient, economical and safe manner. It is also noteworthy that the technology proposed in this patent application meets all patentability criteria: novelty, inventive step and industrial application, requirements necessary for the granting of the requested patent. ADVANTAGES OF THE INVENTION

[032] It is important to highlight that automatic, semi-automatic, and manual devices have been developed for obtaining platelet concentrate. It should be noted that automatic systems require high technology, specialized labor, and a large volume of blood, however, they present a low risk of bacterial contamination. The semi-automatic method allows concentrating a high number of platelets and growth factors, when compared to the other two techniques, and presents a lower risk of contamination than the manual technique; however, the manual method performed by centrifugation in a tube is simple and inexpensive, requiring only adequate aseptic preparation to avoid bacterial contamination.

[032] Regarding the advantages and differentiators presented by the aforementioned 'ADAPTABLE DEVICE AND PROCESS FOR OBTAINING CONCENTRATED PLATELET VOLUME BY DOUBLE CENTRIFUGATION OF PERIPHERAL BLOOD', the most relevant can be highlighted as follows:

[033] As a distinguishing feature of the proposed device and process / technique, it is highlighted that the device used for the collection stage is the same as that used for the centrifugation stage, which reduces the chance of activation. Petition 870170080113, dated 10 / 20 / 2017, page 26 / 43 11 / 16 early platelet count, thus increasing the effectiveness of the technique.

[034] An important differentiating factor is the device's composition involving inert material, preventing adhesion to the wall and platelet degradation.

[035] It is presented as an effective technique and / or process and / or reaction for obtaining a concentrated volume of platelets since it performs two centrifugations, concentrating a greater number of platelets, which makes the technique more effective.

[036] This is an easy-to-apply process, as it does not require sophisticated technology, which reduces costs and consequently increases its applicability and usability.

[037] After the advantages presented, and in order for the invention process proposed in this patent document to be better understood and evaluated, the description of the drawings will be given below. DESCRIPTION OF THE DRAWINGS

[038] The invention will now be explained in detail, and by way of illustration, the following drawings are presented: Figure 1, Figure 2, Figure 3, Figure 4 and Figure 5.

[039] Figure 1 shows, in an illustrative way, and in no way limitingly, a plunger that can be adapted to a 20mL syringe (1).

[040] Figure 2, shows in an illustrative, and in no way limiting, way a blind-ended rod (2).

[041] Figure 3, shows in an illustrative, and in no way limiting, way a blind bottom cover (3).

[042] Figure 4, shows in an illustrative, and in no way limiting, way a plug (4). Petition 870170080113, dated 10 / 20 / 2017, page 27 / 43 12 / 16

[043] Figure 5, shows in an illustrative, and in no way limiting, way a long plug (5). SUMMARY OF THE INVENTION

[044] The main object of this patent application is to describe in detail the process and product related to the said 'ADAPTABLE DEVICE AND PROCESS FOR OBTAINING CONCENTRATED PLATELET VOLUME BY DOUBLE CENTRIFUGATION OF PERIPHERAL BLOOD'. Thus, and more specifically, the invention disclosed herein aims to provide technological information regarding the development of an adaptable device, where said device has differentiated characteristics of being the device used for collection and also the device used for the centrifugation step. In addition, and within the same inventive concept, the process of centrifuging peripheral blood to obtain a concentrated volume of platelets with cicatricial activity (through growth factors contained in the platelets) is revealed.The aforementioned process and / or technique, once implemented, proves to be an effective process and / or technique for obtaining concentrated platelet volume, since it preferentially involves performing two centrifugation steps, increasing the efficiency of the process for obtaining concentrated platelet volume.

[045] The development of the present invention was carried out with the aim of solving the problem existing in the state of the art, which presents as drawbacks the lack of techniques and / or methods and / or processes in which the collection device is the same as that used for centrifugation, which reduces the chance of premature platelet activation and significantly contributes to increasing the effectiveness of said process. Thus, the proposal of this invention is to reduce one step of the preparation process, corresponding Petition 870170080113, dated 10 / 20 / 2017, page 28 / 43 13 / 16 Transferring the peripheral blood collection syringe to the first centrifugation tube. The technique described in this document allows the collection device to be the same as that used for centrifugation, which reduces the chance of premature platelet activation, thus increasing the effectiveness of the technique. In addition to the aforementioned utility, the material developed for the invention is inert, preventing adhesion to the wall and platelet degradation, another important advantage of said device and process disclosed.

[046] Thus, the present invention discloses all parameters related to obtaining and developing a device with adaptable parts and a process for obtaining a concentrated volume of platelets through double centrifugation of peripheral blood, with cicatricial activity, by means of growth factors contained in the platelets, said device and process being characterized as practical, simple, inexpensive and fast. It is emphasized that the intention to simplify the method / process led to the use of simpler equipment. Although it requires learning on the part of those who will perform the procedure, it allows the preparation of the concentrated volume of platelets at a lower cost and in simpler environments, provided they have a centrifuge. In addition to being a method that is easy to reproduce by other teams, it is the first national alternative within the inventive concept presented.

[047] Within the context presented, and in order for the process developed and the product obtained, which is the subject of protection under this patent application, to be understood and evaluated in a clearer and more objective manner, its detailed description will be given below. DETAILED DESCRIPTION OF THE INVENTION

[046] This section will reveal all the details of the said 'ADAPTABLE DEVICE AND PROCESS FOR OBTAINING CONCENTRATED PLATELET VOLUME BY DOUBLE CENTRIFUGATION OF PERIPHERAL BLOOD', the purpose of which is to describe in a sufficient and Petition 870170080113, dated 10 / 20 / 2017, page 29 / 43 14 / 16 clearly, all the steps involved in the process of obtaining the concentrated volume and platelets and the adaptable device used for this purpose, and thus, substantiate the descriptive sufficiency of this invention.

[047] For the development of said adaptable device and process for obtaining concentrated platelet volume where steps (a), (b), (c), (d), (e) and (f) must be considered:

[048] Step (a) ^ Step (a) refers to the use of a special plunger (1), which was preferably designed for 20mL capacity syringes, into which it is possible to initially screw on a blind-ended rod (2) and in this way it is possible to collect 20mL of peripheral blood from the individual. However, it is important to make it clear that syringes of other volumes can be adapted, and this will depend on the dimensions of the special plunger (1) and the blind-ended rod (2).

[049] Step (b) ^ After collection, the needle removal procedure must be performed, and a blind-bottom cap (3) must be screwed on at the site, and on the other side, the stem (2) is removed and the stopper (4) is screwed on. This creates a hermetic and secure system for centrifugation.

[050] Step (c) ^ Step (c) involves the first centrifugation of the material. It is made clear that the centrifugation steps (first and second) can be performed in any type of centrifuge, of any model and brand, with different capacities, provided that it is adaptable to the capacity of the device disclosed.

[051] The first centrifugation must be carried out at a speed between 1000 rpm and 3000 rpm at a temperature of 22°C for a time of 2 to 20 minutes. After this centrifugation process, the stopper (4) must be removed, and the rod (2) must then be screwed onto the plunger (1), and then the blind-bottom cap (3) must be removed, allowing the lower layer of the centrifuged material (red blood cells) to be discarded as the plunger (1) is pressed. Petition 870170080113, dated 10 / 20 / 2017, pp. 30-43 15 / 16

[052] Step (d) ^ Step (d) involves the second centrifugation of the material. For the second centrifugation, the blind-bottom cap (3) must be screwed on again, followed by the removal of the rod (2) and then the long plug (5) must be screwed onto the plunger (1). This second centrifugation must be carried out at a speed between 2000 rpm and 4600 rpm for a time of 5 to 40 minutes.

[053] Step (e) ^ After the second centrifugation, step (e) refers to the removal of the long stopper (5), and a standard syringe, preferably with a capacity of 10ml, should be connected to the plunger (1). Then, the connected syringe should be pressed, and as the plunger (1) is moved, the upper layer of the centrifuged material (comprising platelet-poor plasma - PPP) is moved into the syringe, stopping the progress until the lower layer of the centrifuged material is reached. Subsequently, the 10ml syringe is disconnected, for example, and the PPP is discarded.

[054] Step (f) ^ In step (f), the syringe with a preferred capacity of 10 mL (which may be the same one used in the previous step, or another) must be connected to the plunger (1), where the process of transferring the last layer of the centrifuged material (comprising platelet-rich plasma - PRP) to the syringe must be carried out by moving the plunger (1).

[055] The special piston (1) has dimensions of 25 mm x 21 mm, more specifically 23 mm x 20 mm.

[056] The blind-ended rod (2) has dimensions of 115 mm x 30 mm, more specifically 108 mm x 26 mm.

[057] The blind bottom cover (3) has dimensions of 17 mm x 15 mm, more specifically 12 mm x 11 mm.

[058] The plug (4) has dimensions of 25 mm x 18 mm, more specifically 20 mm x 15 mm.

[059] The long plug (5) has dimensions of 115 mm x 30 mm, more specifically 108 mm x 26 mm. Petition 870170080113, dated 10 / 20 / 2017, pp. 31 / 43 16 / 16

[060] The special plunger (1), the blind-bottom rod (2), the blind-bottom cap (3), the plug (4) and the long plug (5) can be developed using different types of polymeric materials, such as polypropylene, polystyrene, polyvinyl chloride, polyethylene terephthalate, among others, and / or polymer blends, as well as glass, acrylic, stainless steel, among other inert materials.

[061] Within the context presented and after having revealed in detail the entire process and product of this invention, it must, however, once again be made clear that the invention is not limited to the embodiment disclosed and the advantages presented, since those skilled in the art will immediately realize that alterations and substitutions in the formulation and / or process steps can be made within the inventive concept described herein. Therefore, this cannot in any way be considered as limiting the invention, which is limited to the scope of the claims that follow. Petition 870170080113, dated 10 / 20 / 2017, pp. 32-43

Claims

1 / 3 CLAIMS 1. ADAPTABLE DEVICE FOR THE PROCESS OF OBTAINING PLATELET CONCENTRATE VOLUME, comprising platelet-rich plasma (PRP), using a device adaptable to the process and / or technique of double centrifugation of peripheral blood CHARACTERIZED BY being a device comprising the following components: a plunger adaptable to the syringe (1), a blind-end rod (2), a blind-end cap (3), a stopper (4) and a long stopper (5).

2. ADAPTABLE DEVICE, according to claim 1, CHARACTERIZED BY the special piston (1) having dimensions of 25 mm x 21 mm, more specifically 23 mm x 20 mm, the blind-end rod (2) having dimensions of 115 mm x 30 mm, more specifically 108 mm x 26 mm, the blind-end cap (3) having dimensions of 17 mm x 15 mm, more specifically 12 mm x 11 mm, the plug (4) having dimensions of 25 mm x 18 mm, more specifically 20 mm x 15 mm, and the long plug (5) having dimensions of 115 mm x 30 mm, more specifically 108 mm x 26 mm; 3. ADAPTABLE DEVICE, according to claim 1, CHARACTERIZED IN THAT the special plunger (1), the blind-end rod (2), the blind-end cap (3), the plug (4) and the long plug (5) can be developed using different types of polymeric materials, such as polypropylene, polystyrene, polyvinyl chloride, polyethylene terephthalate, among others, and / or polymeric blends, as well as glass, acrylic, stainless steel, among other inert materials.

4. PROCESS FOR OBTAINING CONCENTRATED PLATELET VOLUME, comprising platelet-rich plasma (PRP), using a device adaptable to the process and / or technique of double centrifugation of peripheral blood, defined in claim 1, CHARACTERIZED BY comprising the following steps: a) Step (a) using a special plunger (1), designed for 20mL capacity syringes, into which it is possible to initially screw on a blind-ended rod (2) and thus collect 20mL of peripheral blood from the individual; b) Step (b), after collection, the needle must be removed, and a blind-ended cap (3) must be screwed on in its place, and on the other side, the rod (2) is removed and the cap (4) is screwed on; c) Step (c) involves the first centrifugation of the material;d) Step (d) involves the second centrifugation of the material, the blind bottom cap (3) must be screwed on again, followed by the removal of the rod (2) and then the long plug (5) must necessarily be screwed onto the piston (1) performed at a speed between 2000 rpm and 4600 rpm for a time of 5 to 40 minutes; e) After the second centrifugation, step (e) refers to the removal of the long stopper (5), and a standard syringe, preferably with a capacity of 10ml, should be connected to the plunger (1), then the connected syringe should be pressed, and as the plunger (1) is moved, the upper layer of the centrifuged material (comprising platelet-poor plasma - PPP) is moved into the syringe, stopping the progress until it reaches the lower layer of the centrifuged material, then the 10ml syringe is disconnected, for example, and the PPP is discarded;f) In step (f), the syringe with a preferred capacity of 10 mL (which may be the same one used in the previous step, or another) must be connected to the plunger (1), where the process of transferring the last layer of the centrifuged Petition 870260054441, dated 05 / 06 / 2026, page 8 / 9 3 / 3 (comprising platelet-rich plasma - PRP) to the syringe must be carried out by moving the plunger (1).; 5. PROCESS FOR OBTAINING CONCENTRATED PLATELET VOLUME BY DOUBLE CENTRIFUGATION OF PERIPHERAL BLOOD, according to claim 4, CHARACTERIZED BY step (c) involving the first centrifugation of the material, carried out at a speed between 1000 rpm and 3000 rpm for a time of 2 to 20 minutes, and, after this centrifugation process, the stopper (4) must be removed, and the rod (2) must then be screwed onto the plunger (1), and then the blind-bottom cap (3) must be removed, allowing the lower layer of the centrifuged material (red blood cells) to be discarded as the plunger (1) is pressed. Petition 870260054441, dated 05 / 06 / 2026, page 9 / 9

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