APPARATUS AND EQUIPMENT FOR THE EXTRACTION OF PLATELET-

RICH PLASMA (PRP) FROM BLOOD

THE TECHNICAL FIELD OF INVENTION:

The present invention is related to an apparatus for extraction PRP production means and systems which is also related to means and a system used for separating different elements of blood and is also related to polymer structures with medical grade for extraction PRP from blood with centrifuge.

PRIOR ART:

The purpose of PRP separation is to obtain part of blood which is produced by bone red marrow as cellular elements especially for coagulation under urgent circumstances. In medical science, the application of PRP is in healing wounds, accelerating follicles reconstruction and growth in skeleton reconstruction which is proved helpful in previous years.

Blood is composed of several parts; that is, normal cells and blood plasma. In normal blood cells, blood contains mainly red blood cells and less white blood cells (leucocytes) as well as platelets. In plasma part, it is constituted of water, protein, minerals and some other minor elements.

PRP separation is done in two methods: Using a container for centrifuge is used for the first method and in the second method, they use gel. They call these methods container-based or gel-based depending on which method to apply. In the second method in which gel is applied, only a small portion of platelets are centrifuged out of blood and can be later used and is neither cost-effective nor helpful. However, there is higher efficiency for separating platelets in the second method. When, phases are separated in the blood containers by the help of centrifuge Red blood cells exist in the lowest level. White blood cells are in the next layer and platelets are at top of other two levels with plasma.

Separating platelets is a rather difficult task. Henceforth, long needles and syringes are used for the suction in PRP part, which causes turbulence in separated phases and thus combination of PRP with white blood cells or even red blood cells. This, in turn, leads to lower efficiency.

Among common methods for PRP separation from blood elements is the use of test tube. In past, after phlebotomy, the content would be poured into the tube and placed in centrifuge. After centrifugation, different elements based on suctioning with syringe or similar means are used. However, platelets separation containers and especially PRP developed and different methods for centrifugation were presented.

Among these different methods is invention No.US20140371048Al registered in USPTO on 18 ^th December, 2014. In this method, a Korean company presented a particular kind of blood elements separation containers in the form of an hourglass whose height could be adjusted at the bottom. After pouring a certain amount of blood to the container and the centrifugation, separated layers of blood could be forced up as far as locking the entrance in the hourglass by turning its lower section upside-down and narrowing this part down. Then, by turning the lower section, a polymer needle is inserted into narrower section of the hourglass and seals off the connection between two sections. Afterwards, a syringe extracts it from upper section of fluid in a way that fluid does not get mixed with red blood cells.

In another invention, No.KR20100140348A, another Korean company presents a different device for PRP separation. This model enjoys two lids at the bottom and top. At the top, the needle which moves to middle section of container, which has smaller diameter, can be adjusted. Different phases separate blood layers and without any chaos in different layers of phases as a result of turbulence while extraction, definite amount and place for separation of blood phase was considered.

In another invention, No.US 5399268 under the title “Method for Processing Blood for Human Transfusion” , they presented a method of preparing platelets for long term storage comprises the steps of obtaining whole blood from a human, preparing platelet rich plasma from the whole blood and then passing the platelet rich plasma through a filter under conditions sufficient to remove substantially all leucocytes from the plasma, with steps and occurring in an integrally attached blood bag system within a few hours of step.

In another invention, No.US 4268393 under the title“Apparatus for Centrifugal Separation of Platelet-Rich Plasma” , they presented an invention that relates to an apparatus for separating platelets from blood samples by subjecting the blood sample to centrifugal force in the chamber while displacing the platelets from the blood sample by injecting a relatively small volume of saline into the centrifugally outer end of the chamber. In the preferred apparatus, the saline is injected into the blood sample by driving the chamber supporting the blood sample against a saline filled collapsible cavity under the influence of centrifugal force. In another invention, No .WO 2004026372 under the title“Device and Method for Separating Blood into Leukocyte Depleted Blood Components” , they presented a device for separating blood into blood components comprising: a collecting container for receiving blood (WB), a first satellite container connected, in fluid flow communication, to said collecting container through a leukocyte filter for receiving from said collecting container a leukocyte depleted first blood component (PRP), a second satellite container connected, in fluid flow communication, with said collecting container through said filter for receiving from said collecting container a second leukocyte depleted blood component (PRC), and flow control means for allowing fluid flow from said collecting container selectively into said first or second satellite container through said leukocyte filter and whereby whole blood (WB) can be separated into a first (PRP) and second (PRC) leukocyte depleted blood component with a single leukocyte filter. Preferably the second satellite container is further connected to said collecting container through conduit means by-passing said filter and the valve means are further adapted for allowing the transfer of an additive from said second satellite container into said collecting container only through said conduit means by-passing said filter.

In another invention, No .US 6855119 under the title“Apparatus for Sequestering Platelet Rich Plasma” , they presented a blood separation system which is fully mechanized to collect blood from a patient, separate waste portions of the blood, wash the blood, and redirect the usable portions to a device for re-injecting the usable portions into the patient. The system provides screen displays with detailed setup instructions and instructs the operator at the appropriate times to do certain manual steps. Apparatus for sequestration of platelet rich plasma spins at a high speed sufficient to separate solid cells from the blood sample and then spins at a lower speed for a predetermined time to allow platelets to elute from the solid cells.

Among relevant inventions with elements in separation device of blood and extraction of PRP are some examples as follow:

- Patent KR101128163B1 under the title “Disposable self-platelet concentrate separator”

- Patent KR101140551B1 under the title“Buffy coat extraction kit for self blood skin renewal procedure” - Patent KR101145173B1 under the title “Separate type platelet rich plasma extraction kit”

- Patent W02013055070A2 under the title“Trousse pour l'extraction de plasma”

- Patent KR101277993B1 under the title“Disposable device for separating platelet rich plasma” - Patent W02013100700A1 under the title“Integrated kit for separating blood and concentrating PRP and method for extracting PRP using same”

- Patent KR101279652B1 under the title “Device for separating platelet rich plasma with a coagulation catalyst, method for separating and coagulating platelet rich plasma using the same” - Patent WO2013141436A1 under the title“Blood centrifugation container”

- Patent KR200471027Y1 under the title “Device for separating platelet rich plasma with a coagulation catalyst” - Patent KR200471024Y1 under the title“Disposable container for separating platelet rich plasma”

THE PROBLEMS IN PREVIOUS KNOWLEDGE AND PURPOSE OF THE INVENTION:

Blood is a combination of plasma, red cells, white cells and several kinds of other particles. These blood cells which are also called corpuscles or "formed elements" consist of Erythrocytes (red blood cells, RBCs), Leukocytes (white blood cells), and Thrombocytes (platelets). By volume, the red blood cells constitute about 45% of whole blood, the plasma about 54.3%, and white cells about 0.7%. Platelets and other particles are suspended in plasma. Centrifuged blood has some parts of elements that is sorted by weight of elements. At the top of centrifuged blood, we can find the plasma and some lighter elements. In the middle, white cells and in the buttom of centrifuged blood are red cells. White cells are small parts that stay near the plasma part. Other elements are suspended in buttom of plasma and near the white cells. Low valium and vicinity by white cells are big problems in the extraction of platelets. In old inventions, we are finding some problems regarding extraction part of PRP form separated parts. When operator starts extracting this part by syringe and needle, flow of liquid has a turbulence and this distortion start a mixing of parts between the separated elements of blood. This Problem will be shiny when consider the eyes that, this part is smallest part of the separated elements. White cells and plasma are near this part and we try for extraction platelets-rich plasma for injection or other projects that, this has been poor or high quality for mentions. On the other hand, concentration of operator is very important for this extraction. Parts will mix if operator shakes needle or pulls back this syringe.

The purpose of the invention is to design and produce a means for efficiency in the separation of PRP from blood elements such that the utmost density and purity is observed and cells and blood elements are least damaged.

THE DESCRIPTION OF THE INVENTION:

The present invention is an apparatus and device for separate elements of blood. In this invention an apparatus for the extraction platelet-rich plasma will be presented. This apparatus is a polymeric tube that can be equal in diameter at the top and down. At the top, the use of plastic bottle cap, which is most times made of Polypropylene, enables it to be fixed in the top part by the thread and seal by a gasket. This cap can seal by other methods that use for capping for example sealing similar to a water bottle cap with a ring of same material of cap in the connection area. In this invention, we divided the tube into three parts that make an apparatus.

In the top, we have cylinder by %55 volume of total equipment volume. At the middle of the apparatus we have an incomplete reverse cone that connected to the top part from the base that does not move towards the bottom of the container as a result of centrifugal force during centrifugation because of the existence of protrusion on it. On upper part of the lid, there is a specific connection for connecting syringe through which operator or doctor can extract the content of container if necessary by pushing lid down. Thus, separated blood elements can be extracted without chaos. The cylindrical container ^' s lid is made of medical grade Polypropylene. The lid is in the form of a small cylinder whose external size is perfectly congruent with the container ^' s internal size. In lower section of the lid, there is a protuberant belt which is semicircular. Semicircular shape of exterior side of container's belt gets the lid fixed inside the container. Over the frame of the main container, there is a depressed shape frame in the opening of the container which is symmetrical with the belt-like protrusion of the lid. The collar locates itself in the inner depressions of the container when container door is settled in its place and as a result the movement of lid down during centrifugation of the container's content is impossible because of the presence of centrifugal force.

Similar to this depression in the wall of container, white blood cells are in the concentrator unit ^' s position. The lid could be made of polymers with plastic features or rubber structures. The present lid in upper section is equipped with a threaded connection. This connection can be directly related to where syringe is fixed or used as an interface for the installation an adapter for changing syringe size or possible Peripheral venous catheter. The door can have a one-piece connection or equipped only with a threaded structure for the installation of lid.

In middle section of cylinder, there is a unit called concentrator which can create an appropriate environment for the white blood cells ^' gathering. The shape of intermediary unit in external part is cylindrical and is semi-conical inside and exits from the other side of cylinder. The concentrator is made of Polypropylene or any other polymer that can be qualified in terms of defined standards.

There is a concentrator in middle section and a projected collar in exterior which surrounds the unit like a belt. During the assemblage of the present invention, the concentrator is inserted inside the cylinder and belt section is inserted around the unit inside the depression. The insertion of this projection in the middle of the depression in the cylinder keeps the concentrator in its place during centrifugation. At the bottom of the container, the existence of a flat or semicircular surface is possible. In upper part of the cylinder, a calibrated unit displays the necessary amount of blood to fill the device. After the reception of blood from the donator on whom the PRP operation is done, blood is poured into the cylinder with the help of a syringe or blood bag. Then, the lid on the cylinder is shut down and cylinder inside the centrifuge. If more PRP is required, two cylinders can be simultaneously used. For preventing blood clot during separation procedure, anticoagulant is used Anticoagulant can already be in the cylinder or kept in an ampule and later added to the cylinder by an injection when necessary. After the operation of centrifuge, constituent elements of blood are separated from one another and red blood cells as well as some of platelets are settled in concentrator passage. PRP unit is in upper section of the cylinder and remaining plasma above the upper section of blood elements. Now, lid moves from its place by placing the cylinder in the support stand and installation of a syringe in upper section of the cylinder by pressing it into the lid. In the meantime, PRP in upper section enters the first syringe. After detaching the syringe and installing the second syringe, required number of PRP from cylinder can be inserted in the syringe. Then, by the lid approaching the concentrator, concentrator can be moved by further push and lid alongside with the unit will keep moving downward. In the meantime, white blood cell phase which is separated can enter the third syringe and by pushing both elements down, red blood cells must connect to the fourth syringe. However, after the collection of PRP phase, white blood cells phase and red blood cells phase can be collected by the help of a connected needle to the syringe which enters from upper hole of the lid. In another type of this invention, belt protrusion around the concentrator, exterior environment of this unit can be made in the form of stair and interior section of cylinder in the form of a projected step in lower section. In this model, slipping and falling of concentrator is least possible because of centrifugal force during centrifugation. Needle and syringe should be used for obtaining two lower phases of blood. Aggregator part can be located in external section with smaller diameter.

In the lower part, a cylindrical chamber is arranged in a diameter equivalent to the upper part connected by a curve to the middle part. The possibility of aggregation of the red blood cells in the blood sample will be accumulated in this section and this will account for a volume of 45% of the total volume. When the blood is extracted in the desired container and the container and its contents are placed in a centrifuge device, the blood sample is subjected to centrifugation into various phases of its constituent. In the meantime, the red blood cells accumulate in the lower portion of the container due to their higher density, and the white blood cell phase is placed in the middle of the lower part in the initial curve of the container and the junction of the lower part. Due to the presence of a condensed phase of the platelets aggregated in the middle part, it is possible to concentrate the platelets in the middle portion of the filling of the incomplete cone in this part, and blood plasma along with some of the smaller elements in the blood will accumulate in the upper part. Due to the small volume of the platelet rich phase in the total volume of the extracted sample, the mid-sectional shape causes the maxillary column to decrease due to the decrease in the surface area of the plate, which is why, at the time of the separation of various phases of the blood by the needle and syringe, doctor will have more focus on the total suction of this phase. Due to the variable surface area of the container, it is not possible to produce this side by injection method, and if the injection method is used, the membrane separation line can be a factor in the destruction of the platelet structure, therefore, to form the container the formulation“Blowing” Method is used. In this method, at first, by plastic injection method , some parts is prepared which is designed and manufactured in the upper part in the shape of the threaded door and the curve of the middle section, using a three-part mold with an integrated internal part and a double- sheathed outer section. After injection, the outer part of the mold is separated from each other and, with the help of machine tools; a piece of injection is withdrawn from its internal form, which is another part of the mold. Now we have a piece like Fig. 1, in which the upper part and the middle section are almost complete. Now, in another machine, the initial form is heated during the passage through the thermal burners of the lower part and the polymer forms the component to the soft point. Now the original piece, which has reached a soft point in the lower part, is placed in another machine and the air pressure is applied inside the unit.

Due to the shape of the secondary mold, the soft part of the piece expands due to the positive pressure and extends to the boundary of the secondary mold.

Due to the integrity of the internal part of the unit and the blowing method used in that internal form, the final piece is smooth and polished and without any prominence or sharp edges.

BRIEF DESCRIPTION OF FIGURES:

Figure number one: A view of the initial piece generated by the Injection system. 101 : Container door

102: Container door threads

103: The lower part of the initial piece with a diameter equal to the minimum diameter of the middle section in Fig. 2

Figure number two: Indicates a view of the completed container after Blow Molding

201 : Container door

202: Container door threads

203: Upper part of the container

204: Middle part of the container

205: Connection of the middle section to the lower part

206: Lower part of the container

207 : Seat or container floor