WO2020234623A1 - Appareil et équipement pour l'extraction de plasma riche en plaquettes (prp) à partir du sang - Google Patents

Appareil et équipement pour l'extraction de plasma riche en plaquettes (prp) à partir du sang Download PDF

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Publication number
WO2020234623A1
WO2020234623A1 PCT/IB2019/054121 IB2019054121W WO2020234623A1 WO 2020234623 A1 WO2020234623 A1 WO 2020234623A1 IB 2019054121 W IB2019054121 W IB 2019054121W WO 2020234623 A1 WO2020234623 A1 WO 2020234623A1
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WO
WIPO (PCT)
Prior art keywords
container
blood
prp
extraction
volume
Prior art date
Application number
PCT/IB2019/054121
Other languages
English (en)
Inventor
Ahmad GHANBARI
Original Assignee
Ghanbari Ahmad
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Ghanbari Ahmad filed Critical Ghanbari Ahmad
Priority to PCT/IB2019/054121 priority Critical patent/WO2020234623A1/fr
Publication of WO2020234623A1 publication Critical patent/WO2020234623A1/fr

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/02—Blood transfusion apparatus
    • A61M1/029—Separating blood components present in distinct layers in a container, not otherwise provided for
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/05—Containers specially adapted for medical or pharmaceutical purposes for collecting, storing or administering blood, plasma or medical fluids ; Infusion or perfusion containers
    • A61J1/06—Ampoules or carpules
    • A61J1/065—Rigid ampoules, e.g. glass ampoules
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14—Details; Accessories therefor
    • A61J1/1412—Containers with closing means, e.g. caps
    • A61J1/1418—Threaded type
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L3/00—Containers or dishes for laboratory use, e.g. laboratory glassware; Droppers
    • B01L3/50—Containers for the purpose of retaining a material to be analysed, e.g. test tubes
    • B01L3/502—Containers for the purpose of retaining a material to be analysed, e.g. test tubes with fluid transport, e.g. in multi-compartment structures
    • B01L3/5021—Test tubes specially adapted for centrifugation purposes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/36—Other treatment of blood in a by-pass of the natural circulatory system, e.g. temperature adaptation, irradiation ; Extra-corporeal blood circuits
    • A61M1/3693—Other treatment of blood in a by-pass of the natural circulatory system, e.g. temperature adaptation, irradiation ; Extra-corporeal blood circuits using separation based on different densities of components, e.g. centrifuging
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2202/00—Special media to be introduced, removed or treated
    • A61M2202/04—Liquids
    • A61M2202/0413—Blood
    • A61M2202/0427—Platelets; Thrombocytes
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L2300/00—Additional constructional details
    • B01L2300/04—Closures and closing means
    • B01L2300/041—Connecting closures to device or container
    • B01L2300/042—Caps; Plugs
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L2300/00—Additional constructional details
    • B01L2300/08—Geometry, shape and general structure
    • B01L2300/0832—Geometry, shape and general structure cylindrical, tube shaped
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L2300/00—Additional constructional details
    • B01L2300/08—Geometry, shape and general structure
    • B01L2300/0848—Specific forms of parts of containers
    • B01L2300/0858—Side walls
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/483—Physical analysis of biological material
    • G01N33/487—Physical analysis of biological material of liquid biological material
    • G01N33/49—Blood
    • G01N33/491—Blood by separating the blood components

Definitions

  • 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.
  • PRP separation is to obtain part of blood which is produced by bone red marrow as cellular elements especially for coagulation under urgent circumstances.
  • 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.
  • blood contains mainly red blood cells and less white blood cells (leucocytes) as well as platelets.
  • white blood cells leucocytes
  • 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.
  • 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.
  • 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.
  • No.KR20100140348A another Korean company presents a different device for PRP separation.
  • This model enjoys two lids at the bottom and 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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
  • 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.
  • 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 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”
  • 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.
  • 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 present invention is an apparatus and device for separate elements of blood.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • concentrator 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.
  • a concentrator in middle section and a projected collar in exterior which surrounds the unit like a belt.
  • 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.
  • the existence of a flat or semicircular surface is possible.
  • 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.
  • PRP in upper section enters the first syringe.
  • required number of PRP from cylinder can be inserted in the syringe.
  • concentrator can be moved by further push and lid alongside with the unit will keep moving downward.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • the formulation“Blowing” Method is used.
  • 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.
  • the soft part of the piece expands due to the positive pressure and extends to the boundary of the secondary mold.
  • the final piece is smooth and polished and without any prominence or sharp edges.
  • Figure number one A view of the initial piece generated by the Injection system. 101 : Container door
  • Figure number two Indicates a view of the completed container after Blow Molding

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  • Health & Medical Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Hematology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Chemical & Material Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Analytical Chemistry (AREA)
  • Clinical Laboratory Science (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Pathology (AREA)
  • Vascular Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • External Artificial Organs (AREA)

Abstract

L'invention concerne un appareil et un équipement pour l'extraction de plasma riche en plaquettes (PRP) à partir du sang, qui sont un appareil et un dispositif pour séparer des éléments du sang. Dans la présente invention, un appareil pour l'extraction de plasma riche en plaquettes sera présenté. Cet appareil est un tube polymère qui peut être de diamètre égal en haut et en bas. En haut, l'utilisation d'un bouchon de bouteille en plastique, qui est le plus souvent en polypropylène, lui permet d'être fixé dans la partie supérieure par le fil et scellé par un joint d'étanchéité. Ce capuchon peut être scellé par d'autres méthodes qui utilisent pour boucher, par exemple, un scellage similaire à un bouchon de bouteille d'eau avec un anneau de même matériau de capuchon dans la zone de connexion. Dans la présente invention, nous divisons le tube en trois parties qui constituent un appareil.
PCT/IB2019/054121 2019-05-20 2019-05-20 Appareil et équipement pour l'extraction de plasma riche en plaquettes (prp) à partir du sang WO2020234623A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
PCT/IB2019/054121 WO2020234623A1 (fr) 2019-05-20 2019-05-20 Appareil et équipement pour l'extraction de plasma riche en plaquettes (prp) à partir du sang

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
PCT/IB2019/054121 WO2020234623A1 (fr) 2019-05-20 2019-05-20 Appareil et équipement pour l'extraction de plasma riche en plaquettes (prp) à partir du sang

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WO2020234623A1 true WO2020234623A1 (fr) 2020-11-26

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Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
KR20110009651A (ko) * 2010-12-31 2011-01-28 주식회사 메디사랑 Ｐｒｐ 추출을 위한 혈액분리용기, 혈액농축용기 및 이를 이용한 ｐｒｐ 추출방법
KR101145173B1 (ko) * 2011-10-10 2012-05-14 류종현 분리형 다혈소판 혈장 추출 키트

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
KR20110009651A (ko) * 2010-12-31 2011-01-28 주식회사 메디사랑 Ｐｒｐ 추출을 위한 혈액분리용기, 혈액농축용기 및 이를 이용한 ｐｒｐ 추출방법
KR101145173B1 (ko) * 2011-10-10 2012-05-14 류종현 분리형 다혈소판 혈장 추출 키트

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