WO2014126545A1

WO2014126545A1 - A centrifuge structured for use in making platelet-rich fibrin

Info

Publication number: WO2014126545A1
Application number: PCT/TR2014/000045
Authority: WO
Inventors: Akman Serhan; Akman MELEK; Tunali Mustafa
Original assignee: Akman Serhan; Melek Akman; Tunali Mustafa
Priority date: 2013-02-18
Filing date: 2014-02-10
Publication date: 2014-08-21

Abstract

The invention is about a centrifuge used to obtain high quality of fibrin aimed to use in the diagnosis, hard and soft tissue healing, the treatment of open and closed wounds in all the fields of medicine, dentistry and veterinary medicine by centrifuging the blood of the living beings determining the centrifuge conditions for every group separately, where the centrifuge includes an electric motor with an outer rotor (1), a microprocessor (2.1) providing the control of the electric motor with an outer rotor (1), a motor drive circuit (2) containing the software (2.2), a centrifuge bin (3) including at least one tube binding apparatus (3.1) compatible with the centrifuge connecting part of the tube, an infrared heater lamp enabling interior heating of the cabin and a compressor refrigerant providing interior cooling parts.

Description

DESCRIPTION

A CENTRIFUGE STRUCTURED FOR USE IN MAKING PLATELET-RICH FIBRIN

TECHNICAL FIELD

The invention is about the centrifuge used to obtain high quality of fibrin by selecting human and animal blood separately in the fields of medicine, dentistry and veterinary medicine. PRIOR ART

The use of fibrin adhesives in stimulating wound healing and blood byproducts in wound closures started 40 years ago.

Fibrin is the activated state of plasmatic molecule fibrinogen. These soluble fibrils exist in high quantities in the a-granules of the thrombocytes and molecule plasma and act an important role in thrombocyte aggression during haemostasis. In fact, fibrogen is the last product of all coagulation reactions. Fibrinogen, the soluble protein, turns into non soluble structure fibrin through thrombin. It forms the first cicatricial matrix of the damaged area in the polymerized gel. This structure which turns into biological adhesive builds a protective wall for the vascular structure around the first developed thrombocyte heaps during coagulation.

Thrombocytes consist of the big and multinuclear cell particles of bone marrow called megacaryocyte. Megacaryocyte particles are called thrombocytes when they enter into the systemic circulation. Thrombocytes are the cells that have essential role in coagulation and prevent excessive blood loss during blood vessel injuries. Thrombocytes include a great many cytokine and growing factors causing bone degeneration and soft tissue maturation. The key growth factors Platelet Derived Growth Factor AB (PDGF- AB), Transforming Growth Factor β-1 (TGF -1 ), Vascular Endothelial Growth Factors (VEGF) exist densely in thrombocytes. These growth factors have the potency of stimulating cell multiplication, matrix remodeling and angiogenesis. In the last 20 years, it has been suggested that this cell can be used as a cure after it has been found out better that thrombocytes have an important role in healing wounds. Platelet Rich Plasma (PRP)

Autogenous preparation called Platelet Rich Plasma (PRP) has been used widely in orthopedy, plastic surgery and dentistry. While there are some studies on 5 Platelet Rich Plasma (PRP) with different results, it is a predominant view that it affects the wound healing positively.

One of the important factors determining the features of the Platelet Rich Plasma (PRP) preparation is the substances that will be added to the preparation and provide coagulation. The alterations in the amount and quantity of the 10 substances added have brought about developing a great number of Platelet Rich Plasma (PRP) methods. Platelet Rich Plasma (PRP) methods still keeps their actuality today.

Platelet Rich Fibrin (PRF), in other words thrombocyte rich fibrin, is the second generation thrombocyte concentration developed after Platelet Rich Plasma (PRP) by 15 Dr. Joseph Choukroun in 2001 in France. Platelet Rich Fibrin (PRF) has been described as a leucocyte and thrombocyte rich autologous fibrin biomaterial. Unlike other platelet rich products, this technique does not require anticoagulant, bovine thrombin, calcium chloride or any gelling agents.

In this technique, blood is filled into the tubes to produce Platelet Rich Fibrin (PRF) at 0 once and centrifuged at a proper speed. Three layers occur in the tube at the end of centrifuge.

o The layer of the red blood cells accumulated at the bottom of the tube

o Acellular plasma with low thrombocytes accumulates at the top of the tube o Platelet Rich Fibrin that is PRF coagulum comes off in the middle of the tube.

>5

After the centrifuge procedure, leucocytes and platelet rich coagulum created through natural coagulation mechanism can be obtained without having to do any biochemical modification of blood.

0 PRF Protocol:

The protocol used for PRF procedures nowadays:

• Venous blood (~10 ml) obtained from the case is placed at once into a silicon tube the inside of which is glazed or a glass tube containing no anticoagulant. • Since the platelet activation and fibrin polymerization are triggered immediately in the lack of anticoagulant, the tube is centrifuged at once in the centrifuge previously adjusted to 2700 RPM for 12 min or 3000 RPM for 10 min.

· Following the centrifuge procedure, a layer of the red blood cells accumulated at the bottom of the tube, acellular plasma with low thrombocytes at the top of the tube and Platelet Rich Fibrin, that is PRF coagulum comes off in the middle of the tube,

• Platelet Rich Fibrin (PRF) creates a complex three dimensional fibrin matrix.

Majority of the platelet and leucocytes of the obtained blood accumulate in this fibrin matrix. The emanated coagulum is removed with a dental tweezers and used as it is, or Platelet Rich Fibrin (PRF) coagulum can be turned into membrane by compressing.

The fields where Platelet Rich Fibrin (PRF) and Platelet Rich Fibrin (PRF) membrane are used in medicine and dentistry are: in reinforcing the healing of soft tissues, in the practices of tissue regeneration guided by bone grafting and guided bone regeneration, and covering sinus membrane perforations. Furthermore, it can be used to restore acquired or created bone defects and Platelet Rich Fibrin (PRF) dental implant can also be used for the primary or secondary bone losses that may occur around dental implants.

Platelet Rich Fibrin (PRF) is not only a simple fibrin membrane, it is also a matrix including all molecular and cellular elements that provide optimal healing. Matrix includes all useful components that exist in the blood sample.

The most important features of PRF are that it accelerates soft and hard tissue healing, it has positive effects to stop the bleeding during wound healing, the, it has accelerating effect in the formation of new tissues, it is non-toxic, it causes no immune reaction as it is obtained from the patient's own blood and it enables recovering the incision of wound edges quickly.

Thanks to PRF, recovery time is shorter, improvement quality is better and healing process of the patient is more comfortable. Healing process is quite accelerated thanks to the PRF system which enables the healer cells (platelets, leukocytes, cytokines, growth factors) in the patients' blood to be applied in the operation area concentratedly. The Features of the Centrifuge Used for Platelet Rich Fibrin (PRF)

Centrifuge is a laboratory instrument which performs circular rotational motion usually with the aid of an electric motor with fixed axis and enables to disintegrate solid particles suspended or even emulsified(cells, red blood cells, bacteria) in a liquid through centrifugal forces.

The high speed rate of centrifuged device provides the separation of the mixtures placed in it by the principle of sedimentation.

. Heavy pieces are collected at the bottom of the tube with the help of centrifugal force (outward with circular motion). With the same logic, lighter pieces move towards the top of the tube (move towards the center of the circular movement). Suspensions or emulsions can be easily separated in this way.

All the centrifuges used in the implementation of the above protocols consist of a rotor or a centrifuge cage, drive shaft (shaft), and an engine. Rotor is located in a room that is prepared with a cover and a latch. The rotors of the centrifuges are two types; with a constant angle cap and a horizontal cap. The tubes are placed in slide and cleaning the slide and of the surrounding structures is difficult to clean in these designs.

Most centrifuges contain switch button, time display, speed control, tachometer and a brake. Some centrifuges are fitted with coolant to adjust the temperature in the room. In the common technique, all the centrifuges produced to obtain Platelet Rich fibrin (PRF) perform rotation at a certain speed and appointed time in one direction.

Centrifuges used to produce Platelet Rich Fibrin (PRF) are table centrifuges.

They can operate at room temperature. Some have cooling system and this makes it possible to protect the protein from being denatured.

There are swinging bins in the horizontal rotors of the centrifuge where the desired mixture can cling. When the engine starts, the tubes draw to a horizontal position, with a constant angle contain sloping beds where the tubes are placed. The tubes maintains their angles during rotation.

The rotor should be installed equably in the centrifuges. Considering that tubes two by two are placed into the two opposite bins in a combo rotor, and these two tubes are placed in the closest point of the axis, the bin rotates at the top less when compared to the completely horizontal position. This state causes turbulence due to the baskets fixed at the top and bottom. After all, the vibration is generated although the opposite bins may seem to have been loaded equably. Balancing only the opposite bins is not enough. Balanced distribution of the load in the in a bins is essential.

The motor with internal rotor is used in the horizontal centrifuges and centrifuges with constant angle rotor. The rotor is rotated by the drive shaft and centrifuge process is applied to the tubes that filled with blood and connected to the rotor. In this application, imbalance occurs over time due to the long length of tubes and long drive shaft. Faulty installation of centrifuges speeds up this process.

The problems arising from obtaining Platelet Rich fibrin (PRF) using the present centrifuges are as follows;

^• The cross-linking structure of fibrin produced is not strong enough,

^• The fibrin produced cannot protect the platelets adequately,

^• The lack of the density of the fibrin produced is claimed to make the application difficult in some cases.

^• The resorption time of the fibrin produced is short, consequently it has little effect.

The structure of platelet rich fibrin (PRF) in which many factors are effective should be improved, resorption duration should be extended and its effectiveness should be increased.

BRIEF DESCRIPTION OF THE INVENTION

The structure of platelet rich fibrin (PRF) in which many factors are effective to produce platelet rich fibrin (PRF) should be improved, its utilization should be facilitated, cross ties should be enriched, resorption period should be extended and its efficiency should be increased. Centrifuges used to centrifuge the blood contain many factors that negatively affect the process. Sometimes, imbalance is caused by the unbalanced installation centrifuge and design problems.

We have presented a centrifuge that keeps the environment where blood is centrifuged to obtain platelet rich fibrin (PRF) in the proper temperature, and prevents incapacitation of the centrifuge due to the problems arising from the balancing caused by the length of the shaft and performs the protection of fibrin structure under appropriate conditions that improves the fibrin structure after the centrifuge process.

A program to be run is selected from the software of the centrifuge according to the type of human or animal (live group) blood in the tube. After the selection, the blood in the tube is heated by the infrared heater lamps or cooled by a compressor cooler under the microprocessor control until the temperature is obtained in the protocol to be applied. When the cabin temperature of centrifuge reaches the level of the protocol, centrifuge process is applied in the direction of the first turn at the speed and duration stated in the protocol. Following the completion of the first phase, centrifugation process is completed in the opposite direction of the first rotation at the speed and duration stated in the protocol.

It is kept at the proper temperature during the waiting period indicated in the protocol. Platelet Rich Fibrin (PRF) obtained using this procedure and design has a better fibrin structure than that of the classical method. Richer, more intense and Platelet Rich Fibrin (PRP) with stronger cross ties is obtained with the centrifuge described. The fibrin obtained through the way in which centrifugation is performed by keeping the tubes filled with blood at different special temperatures for each living being has a better fibrin structure than that obtained by conventional methods. THE PROVISIONS OF THE FIGURES

Figure . The Centrifugal Bin and Motor Mounted View

Figure 2. Section View

Figure 3. View from the Motor Driver Circuit

Figure 4. View from the Centrifuge Tube

Provisions to as the part numbers are given below;

. Electric Motor with External Rotor

1.1. Rotor

1.2. Stator

2. Motor Driver Circuit

2.1. Microprocessor

2.2. Software

3. Centrifugal Bin

3.1. Tube Binding Apparatus 4. Tube

4. . Connection Part to the Centrifuge

DETAILED DESCRIPTION OF THE INVENTION

The invention is characterized by the outer rotor electric motor (1 ) with the rotor (1.1 ) outside and the stator (1.2) inside, and the motor drive circuit (2) including a microprocessor (2.1 ) and software (2.2) providing the control of the outer rotor electric motor (1 ), and a centrifugal bin (3) containing at least one tube binding (3.1 ) and a tube (4) with centrifuge connecting portion (4.1 ).

Centrifugation should be performed under different conditions (temperature, speed, cycle time, waiting time after centrifugation) to obtain the Platelet Rich fibrin (PRF) from each species of animal or human blood. The Platelet Rich Fibrin (PRF) produced in accordance with these conditions will be resorbed later, are more effective, more viscous and easier to implement.

The electric motor in our invention is an electric motor (1 ) with outer rotor. As the rotor (1.1 ) of the External-rotor electric motor (1 ) is on the outer surface, is connected directly to the centrifuge (3) saddle, it does not constitute balancing during operation. In this way, This allows for operating long periods of time without causing imbalance. The electric motor (1 ) with outer rotor is controlled by the microprocessor (2.1 ) basing on data entered into the software (2.2), and adjusts the temperature conditions of the cabin where the tube (4) exists.

If the ambient temperature of the cabin inside the centrifuge is lower than the protocol, the temperature is increased to the protocol level by the infrared heater lamps through the centrifugal microprocessor command. If the ambient temperature of the cabin inside the centrifuge is higher than the protocol, the temperature is reduced to the protocol level by the compressor coolers via the microprocessor command.

The tubes (4) from the centrifuged binding section (4.1 ) are connected to the tube binding apparatus (3.1 ) located on the centrifuge bin (3). This design enables cleaning of the environment and allows easier access to the G force by increasing the radius of rotation required. The living group to which blood in the tube belongs is chosen from the software (2.2) by its operator. The predetermined protocol is transmitted to the microprocessor (2.1 ) to centrifuge the blood of the selected living group. Microprocessor (2.1 ) starts the process of centrifugation in the direction of the first turn according to the speed and time of centrifugation protocol after setting the temperature level of the cabin where the tubes exist.

After the first step is completed, centrifugation process in the opposite direction of the first turn is completed according to the speed and time in the protocol. Platelet Rich Fibrin (PRF) is obtained by keeping the centrifuged blood-filled tubes in appropriate temperature conditions during the waiting period specified by the protocol. Thus, the obtained fibrin Platelet Rich (PRF) is more successful. This new centrifuge has positive results to obtain denser fibrin with richer platelet, stronger cross-ties.

With our invention, blood is taken into the tube without delay to obtain Platelet Rich Fibrin (PRF). To perform centrifuge process keeping temperature of the cabinet at a special temperature constant during centrifugation will make the Platelet Rich fibrinogen (PRF) more successful. There is a best temperature to

Therefore, temperature ranges have been encoded in the software (2.2) to achieve the best Platelet Rich Fibrin (PRF) determined for the blood of live groups and Platelet Rich Fibrin(PRF) is created executing the protocol selected according the live group by the operator. After being centrifuged, cross ties stronger, denser platelet-rich fibrin is obtained without requiring any biochemical modification of blood. If the centrifugal cabin in which the tubes (4) exist has a heat value below the predetermined temperature range to obtain the best Platelet Rich fibrin (PRF) , it should be heated, and it should be cooled if the temperature is above the protocol levels. The heating process will be carried out by the infrared heating lamps, and the cooling process will be provided with a compressor refrigerant. Infrared heater lamp is an effective heater in small volumes that is controlled through the information received from the micro-processor.

The compressor refrigerant is a quick cooler controlled by the microprocessor through the information received from the heat sensors.

Claims

C L A I M S

It is the centrifuge established to make platelet-rich fibrin, and its property is characterized in that it includes an electric motor with an outer rotor (1 ), a microprocessor (2.1 ) providing the control of the electric motor with an outer rotor (1 ), a motor drive circuit (2) containing the software (2.2), a centrifuge bin (3) including at least one tube binding apparatus (3.1 ) compatible with the centrifuge connecting part(4.1 ) of the tube(4), an infrared heater lamp enabling interior heating of the cabin, and a compressor refrigerant providing interior cooling parts.

It is the motor drive circuit (2) mentioned in Claim 1 , and its property is characterized in that it includes a software (2.2) and a microprocessor (2.1 ) that controls the speed and the duration of the rotor rotation of the electric motor with an outer rotor (1 ) in the opposite direction of the first rotation defined in the protocol after the rotor (1.1 ) is rotated in the first turning direction.

It is the microprocessor (2.1 ) mentioned in Claim 2, and its property is characterized in that it is the part that controls the heating / cooling of the tube(4) and the cabin in which tube (4) is located until the temperature range specified according to the living beings the operator selected is achieved.

It is the centrifugal bin (3) mentioned in Claim 1 , and its property is characterized in that it moves uniformly with rotor by mounting it directly onto the rotor (1.1 ) of the electric motor with an outer rotor (1 ).

It is the infrared heater lamp mentioned in Claim 1 , and its property is characterized in that it is the part that heats the tube (4) and the cabin in which tube (4) is located under the control of the microprocessor (2.1 ) until the temperature level specified according to the protocol of the living beings the operator selected is achieved.

It is the refrigerant compressor mentioned in Claim 1 , and its property is characterized in that it is the part that cools the tube(4) and the cabin in which tube (4) is located under the control of the microprocessor (2.1 ) until the temperature level specified according to the protocol of the living beings the operator selected is achieved.

7. It is the microprocessor (2.1 ) mentioned in Claim 2, and its property is characterized in that it is the part that provides proper temperature conditions during the waiting period specified by the protocol to the tube (4) in which platelet rich fibrin formed after the completion of the centrifugation process selected by the operator according to the living being group.

8. It is the tube binding apparatus (3.1 ) mentioned in Claim 1 , and its property is characterized in that it is the part that connects the tube (4) from the connection part of the tube (4.1 ) to the centrifuge bin (3).