WO2013055070A2 - Plasma extraction kit - Google Patents

Plasma extraction kit Download PDF

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Publication number
WO2013055070A2
WO2013055070A2 PCT/KR2012/008148 KR2012008148W WO2013055070A2 WO 2013055070 A2 WO2013055070 A2 WO 2013055070A2 KR 2012008148 W KR2012008148 W KR 2012008148W WO 2013055070 A2 WO2013055070 A2 WO 2013055070A2
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WO
WIPO (PCT)
Prior art keywords
extraction kit
prp
plasma
plasma extraction
blood
Prior art date
Application number
PCT/KR2012/008148
Other languages
French (fr)
Korean (ko)
Other versions
WO2013055070A3 (en
Inventor
류종현
Original Assignee
Reu Jong-Hyun
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
Priority claimed from KR1020110102863A external-priority patent/KR101145173B1/en
Priority claimed from KR1020120108913A external-priority patent/KR101267379B1/en
Application filed by Reu Jong-Hyun filed Critical Reu Jong-Hyun
Publication of WO2013055070A2 publication Critical patent/WO2013055070A2/en
Publication of WO2013055070A3 publication Critical patent/WO2013055070A3/en

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    • BPERFORMING OPERATIONS; TRANSPORTING
    • B01PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01LCHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L3/00Containers or dishes for laboratory use, e.g. laboratory glassware; Droppers
    • B01L3/50Containers for the purpose of retaining a material to be analysed, e.g. test tubes
    • B01L3/502Containers for the purpose of retaining a material to be analysed, e.g. test tubes with fluid transport, e.g. in multi-compartment structures
    • B01L3/5021Test tubes specially adapted for centrifugation purposes
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M1/00Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/02Blood transfusion apparatus
    • A61M1/029Separating blood components present in distinct layers in a container, not otherwise provided for
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B01PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01LCHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L2300/00Additional constructional details
    • B01L2300/04Closures and closing means
    • B01L2300/041Connecting closures to device or container
    • B01L2300/042Caps; Plugs
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B01PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01LCHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L2300/00Additional constructional details
    • B01L2300/04Closures and closing means
    • B01L2300/041Connecting closures to device or container
    • B01L2300/044Connecting closures to device or container pierceable, e.g. films, membranes
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B01PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01LCHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L2300/00Additional constructional details
    • B01L2300/04Closures and closing means
    • B01L2300/046Function or devices integrated in the closure
    • B01L2300/049Valves integrated in closure

Definitions

  • the present invention relates to a plasma extraction kit, and more particularly, a device used to separate and extract a specific component of blood, to increase the concentration and purity of a specific component to be extracted and to easily extract a specific component from the blood.
  • the present invention relates to a plasma extraction kit that is easy to disinfect and convenient.
  • blood cells in the blood are mixed with different specific gravity components, when centrifuged to form a layer by each type.
  • PRP platelet rich plasma
  • 'PRP' Platelet Rich Plasma Platelet Rich Plasma
  • Platelets have a regenerative effect because platelet cells contain abundant growth factors. Injecting high levels of platelets into the treatment area causes platelet growth factors to activate stem cells to regenerate damaged tissue. The higher the concentration of PRP, the greater the therapeutic effect.
  • the general PRP extraction process first collects blood from the human body and centrifuges it. Several cells are mixed in the blood. When centrifuged, homogeneous cells are collected and layered according to specific gravity.
  • the blood consists of a solution component and a blood cell component (grain cell), which contains red blood cells, white blood cells, platelets, and a very small amount of antibodies, which are mixed and floated in a solution with 0.9% salinity. Red blood cells constitute the majority of the blood cell components.
  • the blood When the blood is centrifuged, it is separated into three layers.
  • the heaviest red blood cells are collected at the bottom of the centrifuge tube, and platelets and leukocytes are gathered on the upper layer to form a thin layer. Missing solution components are placed.
  • the platelet and leukocytes are concentrated together, and the thin layer is called PRP, and the plasma layer composed only of solution without blood cell granules above is called PPP (Platelet Poor Plasma). .
  • Patent Document 1 Korean Registered Patent No. 1016166 (Method for separating autologous platelet concentrate)
  • Patent Document 2 Korean Registered Patent No. 1043231 (centrifugal separation method and adapter used therein)
  • Patent Document 3 Korean Registered Patent No. 1029255 (centrifugal separator)
  • the PRP appears as a very thin layer, which appears to be thin and widely spread over the entire red blood cell layer directly below, and the thickness of the red blood cell that is collected at the bottom is different depending on the person. Since the ratio of the total volume of the whole blood varies from as little as 25% to as much as 50%, it is not easy to extract high purity PRP.
  • the needle In order to extract PRP thinly spread on the top of the erythrocyte layer, the needle is inserted into the test tube, and the tip of the needle touches the PRP layer and is extracted by inhaling it. In the process, a significant number of red blood cells are sucked in with the PRP, and these red blood cells are injected into the tissue along with the PRP when the patient is treated.
  • Erythrocytes sucked into PRP cause two problems. First, the higher the amount of red blood cells, the lower the concentration of PRP, which lowers the therapeutic effect. Second, the patients complain of severe pain after the procedure. Cause. Even with pure PRP, there is some pain after treatment, which lasts as long as 1 day and as long as 1 week. In some cases, narcotic analgesics may be required. When the red blood cells are injected together, the pain becomes more severe. For this reason, several methods are used to prevent the inclusion of red blood cells in PRP extraction. The most commonly used method is to reduce the diameter of the centrifuge tube in the area where the PRP layer is expected to form and to reduce the proportion of PRP.
  • a correction device that adjusts the height of the red blood cell layer in the lower part of the separator to position the PRP in the narrow neck portion should be accompanied.
  • a screw-shaped stopper in the lower part of the centrifuge tube may be locked or released depending on the situation. Rotating in the direction to control the height of the red blood cell layer.
  • the centrifuge tube of this type has a great escape pressure of blood in the lower part of the centrifuge tube during the high-speed rotation of 3000-4000RPM, and there is a possibility that blood can flow out through the screw part.
  • a piston is inserted into the upper part to be movable, the lower portion is formed with a needle connector is fixed to the needle, the inside is filled with a certain amount of serum separation gel for separating blood and serum therein;
  • a protrusion which protrudes above the needle connector formed in the lower portion of the cylinder and is formed inside the cylinder so that the serum separation gel filled in the syringe is not discharged toward the needle connector where the needle is fixed;
  • a lower stopper which is fixed to the lower part of the needle connector when the needle is removed from the needle connector of the cylinder to which the needle is fixed, and a seal which seals the needle connector protrudes upward;
  • the cylinder is sealed by an upper cap.
  • a method of sterilization by high temperature steam As a disinfection method of such a medical device, a method of sterilization by high temperature steam, a method of sterilizing by adding EO gas, and a method of sterilizing by irradiating gamma rays are mainly used.
  • sterilization by high temperature steam not only is it difficult to apply to plastic products, but also has a problem of being difficult to sterilize in a sealed state. It is difficult to disinfect the inside of medical devices because it is released in the state, and the sterilization method that irradiates gamma rays can be applied to plastic products, but it is difficult to apply to plastic products and the manufacturing cost becomes expensive because special treatment must be performed to endure gamma rays. There was a problem.
  • the present invention is to solve the above-mentioned problems of the prior art, an object of the present invention is not only capable of disinfection in a sealed syringe or plasma extraction kit manufactured at the factory, but also when injecting the blood extracted from the patient into the kit It is to provide a plasma extraction kit that is less concerned about contamination and easy to inject and seal.
  • another object of the present invention is to provide a plasma extraction kit in which the extracted PRP is increased in purity and concentration, the ease of extraction operation is further improved, and the manufacturing cost can be reduced.
  • the upper end is opened and the lower end is closed with a cylindrical body portion, and fastened to the inner central portion of the main body portion, the diameter of the central portion is small and both ends It characterized in that it comprises a funnel portion formed in a tapered shape that gradually decreases in diameter toward the central portion, and a cover portion for closing the upper end of the main body portion.
  • the present invention is the second centrifugal to further extract the plasma by the second centrifugation from the PPP and erythrocytes of the centrifuged blood after the first centrifugation of the blood injected by the plasma extraction kit for extracting the plasma components from the blood Characterized in that comprises a separator tube.
  • the present invention having the above-described configuration, it is possible to easily extract a high-purity high concentration of PRP, can be extracted by almost eliminating red blood cells in the extraction process, the degree of variation is small according to the operator and the extraction time can be shortened By lowering the manufacturing cost of the centrifuge tube, there is an advantage that can reduce the treatment cost of the operators. After centrifugation, a large amount of red blood cells in the blood component is accommodated in the blood storage unit, and a small amount of PRP can be accommodated in the center of the funnel having a small diameter, thereby facilitating extraction of a small amount of PRP.
  • the PRP can be accurately positioned in the funnel, thereby easily extracting high-purity PRP with high purity and red blood cells in the extraction process.
  • the extraction can be almost excluded, and the degree of variation according to the operator is small, the extraction time can be shortened, and the manufacturing cost of the centrifuge tube can be lowered to reduce the treatment cost of the operators.
  • FIG. 1 is a view showing a plasma extraction kit of the prior art
  • FIG. 2 is a view showing a plasma extraction kit according to a first embodiment of the present invention
  • FIG. 3 is a perspective view and a cross-sectional view of the plasma extraction kit of the first embodiment
  • FIG. 4 is a perspective view and a cross-sectional view of the funnel to be inserted into the plasma extraction kit of the first embodiment
  • FIG. 6 is a cross-sectional view showing the first PRP and PPP extraction
  • FIG. 7 is a cross-sectional view showing the appearance of excess red blood cells after the first centrifugation
  • Figure 8 is a cross-sectional view showing the appearance of red blood cells under the first centrifugation
  • FIG. 11 is a cross-sectional view showing the extraction of the PPP of the upper layer
  • FIG. 12 is a cross-sectional view showing a small amount of remaining PPP, PRP, small amount of red blood cells,
  • FIG. 13 is a cross-sectional view showing a state of extracting the final PRP
  • FIG. 14 is a perspective view showing a plasma extraction kit according to a second embodiment of the present invention.
  • FIG. 15 is a cutaway perspective view of FIG. 14; FIG.
  • FIG. 16 is a cross-sectional view of the plasma extraction kit according to a second embodiment of the present invention.
  • 17 and 18 are views showing the outer cylinder of the plasma extraction kit according to a second embodiment of the present invention.
  • FIG. 19 is a view showing the opening and closing cap of the plasma extraction kit according to a second embodiment of the present invention.
  • FIG. 20 is a view showing a cover portion of the plasma extraction kit according to a second embodiment of the present invention.
  • 21 is a view showing the connection blade portion of the plasma extraction kit according to a second embodiment of the present invention.
  • FIG. 22 is a diagram showing an example of use of the plasma extraction kit according to the second embodiment of the present invention.
  • Plasma extraction kit the upper end is opened and the lower end is closed, the main body portion is fastened to the inner central portion of the main body portion, the diameter of the center portion is small and both ends are gradually reduced in diameter toward the center portion A funnel formed in a tapered shape, and a cover portion for closing the upper end of the main body portion.
  • the inner side of the main body portion is characterized in that the locking step is formed to prevent the separation to maintain the funnel in a predetermined position.
  • the opening and closing is fastened to the cover portion, characterized in that it comprises an opening and closing cap having an injection hole on one side that can be inserted into the needle of the syringe for injecting blood extracted from the patient.
  • the opening and closing cap and closes the opening formed in the center of the upper surface, characterized in that it further comprises a sealing membrane formed of a material that can be easily inserted into the syringe for extracting the multi-platelet plasma of the centrifuged blood.
  • the cover part has a fastening hole formed at the center thereof, and includes a protrusion projecting from the fastening hole, and the opening / closing cap is provided with a locking protrusion projecting outward from the lower end to be locked to the protrusion of the cover part.
  • the funnel characterized in that it further comprises a blood storage unit for receiving the blood is installed is installed in the inner bottom of the main body portion.
  • the funnel is formed of an inner cylinder formed in a tapered shape in which the diameter of the center portion is small and both ends thereof are tapered in diameter gradually decreasing toward the center portion, and an outer cylinder formed in a hollow cylindrical shape in which upper and lower portions are opened and both ends of the inner cylinder are fastened. It is characterized by.
  • the outer cylinder is formed with a fastening protrusion protruding outward, the inner surface of the main body portion is indented concave inwardly and has a predetermined width, the fastening protrusion is inserted into the fastening groove for limiting the movement of the fastening protrusion is It is characterized by being formed.
  • one end is connected to the funnel and the other end is bent and characterized in that it further comprises an elongated rod-shaped connecting blade formed with a fastening projection engaging the thread of the cover portion.
  • connection blade portion is characterized in that it comprises a first wing portion formed in a T-shape at one end, and a connecting projection fastened to the fastening screw formed on the cover portion at the other end.
  • the upper end portion of the outer cylinder is formed by cutting in a T-shape and characterized in that it further comprises a locking groove that is fastened to the first wing portion.
  • the second centrifugal centrifugation to further extract the plasma from the PRP, PPP and erythrocytes of the centrifuged blood by centrifugation of the injected blood first Characterized in that further comprises a separation tube.
  • the secondary centrifuge tube is formed in a cylindrical shape, the lower end of the secondary centrifuge tube is formed with a second capillary tube having a smaller diameter than the upper portion, the tip portion of the second capillary tube is gradually reduced in diameter is formed It is characterized by being.
  • FIG. 2 to 13 is a view showing a plasma extraction kit according to a first embodiment of the present invention.
  • the plasma extraction kit 1 is provided as two centrifuge tube cylinders of different shapes, respectively, used as a main body portion, secondary centrifuge tube, each The shape is provided as designed to be easily used in the extraction process.
  • the inlet of the main body and the secondary centrifuge tube which will be described later, is closed by lids 40 and 40 ', and the central portion of the lid is formed with perforations 42 and 42' through which a needle can enter. It is configured to inject blood by inserting a needle through the drilling hole without removing the upper cover, the cover is formed of a soft elastic material to be safe from external infection.
  • the above-described cover has a portion to be inserted into the main body portion, the surface of which is formed with threads 41 and 41 '.
  • a funnel portion 20 formed in a cylindrical shape is inserted into the main body portion, and a capillary tube 23 having a long narrow diameter penetrating the upper and lower portions of the funnel portion is formed in the center of the funnel portion 20.
  • the upper and lower ends of the capillary are formed with funnel-shaped tapered portions 21 and 22 that are narrower or wider in diameter, and the main body and the funnel are formed of a transparent material and are located in the inner capillary from the outside. Blood components can be seen clearly.
  • the inserted funnel is provided in close contact with the inner diameter of the main body portion accurately.
  • the inclination of the funnel-shaped taper is designed differently for the upper and lower parts.
  • two narrow, long rod-shaped connecting wings 24 extend upward, leading to the cover, the end of which is bent inward to form a fastening protrusion 25 to form a screw thread at the bottom of the cover. It is provided in a state capable of being bitten by 26.
  • the funnel portion of the lower portion connected to the connecting wing part is changed in height while moving up and down along the thread of the cover.
  • the side of the cover is made of irregularities (43) to increase the friction force during rotation
  • the funnel When the funnel is connected to the cover by a wing, it is floating in the middle without descending to the bottom of the main body.
  • the top and bottom of the cylinder of the portion where the funnel is located is provided with a locking jaw 27 is spaced by a predetermined distance so that the cylindrical structure does not reach the floor or come out of the upper limit.
  • the lower space of the funnel portion is a space in which red blood cells are collected during centrifugation, and the blood storage unit 30 calculates the diversity of red blood cells of each person and secures a space of appropriate capacity.
  • the secondary centrifuge tube (2) is formed in a substantially cylindrical shape, the lower end of which is formed a narrow second capillary tube (71) having a smaller diameter than the upper portion, and the end of the second capillary tube (71) is conical. As the diameter becomes smaller, the tip portion 72 is formed which ends at the vertex.
  • Centrifugation to extract the PRP is usually carried out twice. After the first centrifugation, the ratio of the upper plasma and the lower red blood cells is measured, and the position is adjusted. Then, the second centrifugation is performed. The products developed so far are performed twice in an integrated centrifuge tube.
  • the plasma extraction kit according to the present embodiment is characterized in that the first centrifugation and the second centrifugation are performed in different centrifuge tubes.
  • the plasma extraction kit 1 of the present embodiment is designed to accommodate the range of this deviation and facilitate extraction.
  • the plasma extraction kit 1 is divided into an upper space 10, a funnel 20, and a blood storage unit 30 from above.
  • the upper space 10 is a section where plasma is collected
  • the blood storage unit 30 is a space where red blood cells are collected
  • the funnel 20 is designed to form a boundary of two layers.
  • the upper end 21 and the lower end of the funnel are formed with funnel-shaped tapered parts 21 and 22 that are gradually smaller or larger in diameter so that the blood cell components can be moved well during centrifugation.
  • the plasma extraction kit has a capacity designed so that the red blood cells in the range showing the distribution of the upper and lower 80-90% of the total based on the average red blood cells can be accommodated in the lower space and the narrow and long capillary 23 of the funnel. It is. Therefore, after the first centrifugation, the position of the uppermost layer of red blood cells is located in any part of the capillary. Immediately above, the PRP is densely packed and thickened as the cross-sectional area of the centrifuge tube is reduced. In this case, the needle is inserted directly without the need for height adjustment of the funnel to extract all of the upper PPP including the PRP at once.
  • the cover 41 is turned to turn the height of the inner tube.
  • PRP layer is located in any part of the capillary and PRP and PPP are extracted in the manner described above.
  • the length of the capillary tube is very long, so even if the position adjustment is a little, the position of the PRP falls within the acceptance range of the capillary tube, which is much easier to extract than the narrow capillary product.
  • the extracted PPP, PRP and a small amount of sucked red blood cells are transferred to the secondary centrifuge tube (2) and subjected to secondary centrifugation.
  • the secondary centrifuge tube 2 is formed in a substantially cylindrical shape, and at the lower end thereof, a narrow second capillary tube 71 having a smaller diameter than the upper portion is formed, and the second capillary tube 71 is formed.
  • a conical shape is made smaller in diameter and ends are formed with a tip portion 72 ends with a vertex.
  • Centrifugation with this specially designed secondary centrifuge tube forms PPP, PRP, and a small amount of red blood cells inhaled from the top.
  • the lowest red blood cells are all contained within the tip portion 72 of the secondary centrifuge tube.
  • the needle touches the PRP layer and extracts the remaining liquid except the lower red blood cells, and since the lower red blood cells are collected only in a very narrow space, it is possible to extract only a small amount of PPP and PRP with very little touch without extracting them. High concentration PRP can be obtained.
  • Another method is to first extract the red blood cells and discard them by inserting the needles into the red blood cell layer of the uppermost space of the bottom layer, and then extracting and discarding the upper layer of PPP, leaving only a small amount of PPP and PRP. This ensures high purity and high concentration of PRP treatment solution by extracting all the remaining solution in the cylinder all at once without the need for timely extraction.
  • Another advantage of using this device is the ability to control the concentration of PRP.
  • concentration of PRP changes according to the amount of PPP remaining.
  • the number of platelets in a normal person is about 100,000 to 200,000 per microliter, but the concentration should be concentrated to more than 1 million, which is five times that of PRP.
  • PRP is extracted including a small amount of PPP in order to secure an appropriate volume of PRP injection. If you want to extract different concentration rates, adjust the amount of PPP remaining when extracting PPP in the upper layer after the second centrifugation. Just do it. If you leave a lot of PPP, the dose of the final treatment injection will increase, but it will be a low concentration of PRP. If you leave less PPP, you will get a high concentration of PRP, although the dose of treatment injection is small.
  • the question of how much the final treatment dose is to be determined is determined by the treating physician according to the area of the treatment site.
  • the use of this device has the advantage that the concentration control can be very simple.
  • Both the main body and the secondary centrifuge tube are made of a closed type with no connecting part, so it is also characterized by a robust structure without fear of blood leakage by high-speed rotation.
  • Extracting PRP using the plasma extraction kit according to the present embodiment has the following advantages.
  • the capillary is tapered up and down, and the central part is elongated to accommodate most of the variation due to the change in red blood cell volume, so that no time is required to extract PRP.
  • erythrocytes included in the extraction of PRP and PPP after the first centrifugation can be excluded through the second centrifuge tube, so that PRP can be extracted without high erythrocytes.
  • the fourth designed second centrifuge tube can be used to control the concentration of PRP as described above.
  • the main body and the second centrifuge tube are designed to be operated without opening the lid, which is safe against external infection.
  • the seventh lower part is simpler in structure compared to the existing blood separation device with a height adjusting screw, and thus can be manufactured at a low cost.
  • FIG 14 to 22 are diagrams showing the plasma extraction kit 100 according to the second embodiment of the present invention.
  • the plasma extraction kit is the main body 110, the cover 120, the blood storage 130, the funnel 140, 141, Connection wing unit 150, and includes an opening and closing cap 160.
  • the main body 110 is formed in a cylindrical shape with an upper end opened and a lower end closed.
  • the material of the main body 110 is not particularly limited, but in the present embodiment, the material is made of a plastic material having low manufacturing cost and easy manufacturing.
  • a fastening groove 110b is formed at the center of the inner surface of the main body 10.
  • the fastening groove 110b is formed to be concavely cut away from the inner side of the main body, and is formed to have a constant width without being formed over the entire circumference of the inner side of the main body.
  • the funnel portion to be described later is placed on the stepped portion 110a formed at the bottom of the fastening groove 110b, and the rotation of the funnel portion by the movement of the connection blade to be described later is performed by the fastening groove. It is configured to be limited by the width.
  • An upper portion of the main body portion is provided to seal the main body portion with a sealing member 110c such as a packing or an O-ring interposed between the main body portion and a cover portion described later.
  • a sealing member 110c such as a packing or an O-ring interposed between the main body portion and a cover portion described later.
  • the blood storage unit 130 is accommodated in the inner lower end of the main body.
  • the blood reservoir is formed in a cylindrical shape with an upper end opened and a lower end closed, and is hermetically received inside the main body.
  • the blood storage unit 130 receives the red blood cell portion of the blood after centrifugation of the injected blood.
  • Funnels 140 and 141 are installed above the blood storage unit in the main body.
  • the funnels 140 and 141 are fastened to the inner central portion of the main body, and as shown in FIGS. 15 and 16, the diameter of the central portion is small and both ends are formed in a tapered shape in which the diameter gradually decreases toward the central portion.
  • the quality of the extract may vary, but according to the present invention, after centrifugation, a large amount of red blood cells in the blood component is accommodated in the blood storage unit, and a small amount of PRP can be accommodated in the center of the funnel having a small diameter. Even if a small amount of PRP is accommodated in the central portion of the funnel having a small diameter, it is possible to easily extract high-purity high concentrations of PRP, and almost eliminate red blood cells in the extraction process.
  • the funnel portion may be formed as one unit, but in the case of injection molding of plastic material, the inner portion of the central portion having a small diameter may cause a defect such as the generation of bubbles due to the occurrence of a defect.
  • the inner portion of the central portion having a small diameter may cause a defect such as the generation of bubbles due to the occurrence of a defect.
  • it is formed separately from the outer cylinder 140.
  • the inner cylinder 141 is formed in a tapered shape in which the diameter of the central portion is small and both ends gradually decrease in diameter toward the central portion.
  • the outer cylinder 140 is formed in a hollow cylindrical shape of the upper and lower openings, the lower end of the outer cylinder is formed to extend inward to protrude, the seating groove 140b is provided on the upper end of the protruding portion.
  • the lower end of the tapered shape of the inner cylinder is inserted and seated in the seating groove 140b so that the inner cylinder and the outer cylinder are integrally connected to each other.
  • the outer cylinder 140 has a fastening protrusion 140a protruding outward from the outer surface of the outer cylinder along the longitudinal direction of the outer cylinder.
  • the fastening protrusion 140a is inserted into the fastening groove 110b of the main body.
  • the locking fixing groove 140c is formed by cutting in an inverted T shape from the upper end of the outer cylinder.
  • the locking blade groove (140c) is inserted so that the first wing portion of the connecting blade portion to be described later is configured so that the connecting blade portion and the outer cylinder behave integrally.
  • connection blade when the connection blade is connected to the upper end of the outer cylinder, and the connection blade is screwed to the cover portion as described below, when the cover portion rotates, the connection blade portion and the outer cylinder connected thereto are rotated.
  • the fastening protrusion of the outer cylinder is rotated by the width of the fastening groove in the state inserted into the fastening groove of the main body portion is blocked by the end of the fastening groove, thereby the outer cylinder is stopped rotation is the connection blade It is configured to move the position from the inside of the main body portion to the upper or lower by the rotation of the cover portion in a fixed state.
  • the PRP can be accurately positioned in the funnel part, whereby a small amount of PRP has a diameter. It can be accommodated in the center of a small funnel, and even if a small amount of PRP is accommodated in the center of a small funnel, it can easily extract high-purity PRP with high purity and almost eliminate red blood cells in the extraction process. .
  • connection wing 150 is one side is fastened to the cover portion, the other side is fastened to the outer cylinder.
  • the connecting wing unit 150, the first wing portion 152 is formed in a portion that is fastened with the outer cylinder, the connection protrusion 151 is formed on the side that is fastened to the cover portion.
  • the first wing portion 152 protrudes outward from the width of the connecting wing portion to have a T-shape, and is inserted into the locking fixing groove 140c.
  • the connecting protrusion 151 is formed to protrude a predetermined length toward the inner side, that is, the central side of the main body portion from the main body of the connecting wing portion, is configured to be fastened to the screw thread formed in the cover portion.
  • the cover part 120 is provided at an upper portion of the main body part, and the cover part 120 is configured to close the upper end of the main body part.
  • the cover part 120 includes an upper surface covering an upper end of the main body and an extension part extending downward from the upper surface and inserted into the main body, and a thread 121 is formed on an outer circumferential surface of the extension.
  • the screw thread is configured such that the connecting projection of the connecting blade portion is screwed.
  • a support protrusion 122 is formed between the upper surface of the cover portion and the extension portion, so that the sealing member 110c is installed between the lower portion of the upper surface and the support protrusion to stabilize the cover portion and the main body portion. It is configured to be sealed by.
  • a fastening hole 123 is formed in the center of the upper surface of the cover part, and the opening and closing cap 160, which will be described later, is inserted into the fastening hole 123 to be opened and closed.
  • the cover portion is formed with a protrusion 124 protruding toward the center of the fastening hole. The protrusion of the opening / closing cap to be described later is locked to the protrusion, and the opening / closing cap is configured to be opened and closed stably without being separated from the cover part when the opening / closing cap is opened or closed.
  • the opening and closing cap 160 is inserted into the fastening hole 123 of the cover part.
  • the opening and closing cap 160 is fastened to the cover portion to be openable.
  • the opening / closing cap 160 includes an injection hole 161, locking protrusions 162a and 162b, and a sealing membrane 163.
  • the injection hole 161 is formed on one side of the main body of the opening and closing cap so that the needle of the syringe for injecting blood extracted from the patient can be inserted.
  • the locking protrusion is composed of an upper locking protrusion 162b and a lower locking protrusion 162a and protrudes outward from the main body of the opening / closing cap.
  • the lower locking protrusion 162a comes into contact with the lower surface of the protruding portion of the cover part, and when the closing cap is closed, the upper locking protrusion 162b is upper surface of the protruding portion. Abuts against and seals between the lid and the opening / closing cap.
  • the sealing membrane 163 closes the opening formed at the center of the upper surface, and is preferably formed of a material into which a syringe for extracting the multiplatelet plasma of the centrifuged blood can be easily inserted.
  • the plasma extraction kit according to the present invention manufactured in a factory is sealed in a wrapping paper with the opening and closing cap open from the cover part.
  • the wrapping paper is preferably made of a special paper material that one side can penetrate the disinfection gas.
  • the plasma extraction kit is sterilized using a disinfection gas such as EO gas in the sealed state
  • a disinfection gas such as EO gas
  • the disinfection gas penetrating the packaging is injected into the plasma extraction kit through the injection hole of the opening and closing cap to facilitate disinfection. It is done.
  • the wrapping paper is peeled off, and the needle of the syringe containing the blood extracted from the patient is injected through the injection hole of the opening / closing cap.
  • pressing the opening and closing cap seals the lid and the opening and closing cap to complete preparation for plasma extraction.
  • the plasma extraction kit is centrifuged by a centrifuge, and a plasma collection syringe is injected through the sealing membrane of the opening / closing cap. Then, the end of the needle is inserted into the center of the small diameter of the funnel to insert the PRP. It can be extracted simply.
  • an opening and closing cap that can be opened and closed on the cover portion and the injection hole in the opening and closing cap, even if the plasma extraction kit is sealed with a wrapping paper in the state that the cover portion is fastened to the EO gas
  • disinfecting by the disinfection gas can be introduced into the plasma extraction kit through the injection hole of the opening and closing cap can facilitate disinfection.

Abstract

The present invention relates to a plasma extraction kit comprising: a cylindrical main body portion in which the upper end is opened and the lower end is closed; a funnel portion which is fastened to the inner central portion of the main body portion and is formed into a tapered shape in such a way that the diameter of the central portion is small and the diameters of the both ends gradually decrease as they approach the central portion; a cover portion for closing the upper end of the main body portion; an open/close cap fastened to the cover portion in an openable/closable manner, in which an injection hole, into which a needle of a syringe for injecting the blood extracted from a patient can be inserted, is formed at one lateral side of the open/close cap; and a second centrifuge tube for further extracting plasma from PPP and erythrocyte of the centrifuged blood by second centrifugation. A large amount of erythrocytes among blood components are accommodated in a blood storage portion after centrifugation, and a small amount of PRP can be accommodated in the middle of the funnel portion having a small diameter, thereby facilitating extraction of a small amount of PRP. In addition, even though the amount of erythrocytes depends on an individual, the position of the funnel portion can be controlled by the configuration of a connection wing portion and the funnel portion, and thus it is possible to precisely locate PRP at the funnel portion. Further, a sterilizing gas can be injected into the plasma extraction kit through the injection hole of the open/close cap, thereby facilitating sterilization. Additionally, since opening the open/close cap, injecting blood by inserting the needle of a syringe into the injection hole of the open/close cap, and then pushing the open/close cap so as to seal the same is enabled, contamination is not a large concern when using the same and the invention is convenient to use.

Description

혈장 추출 키트Plasma extraction kit
본 발명은 혈장추출키트에 관한 것으로서, 더욱 상세하게는 혈액의 특정 성분을 분리 추출하기 위하여 사용되는 장치로서 추출하고자 하는 특정성분의 농축율과 순도를 높이고 혈액에서 특정성분의 추출이 용이할 뿐만 아니라, 소독이 용이하고 간편한 혈장추출키트에 관한 것이다. The present invention relates to a plasma extraction kit, and more particularly, a device used to separate and extract a specific component of blood, to increase the concentration and purity of a specific component to be extracted and to easily extract a specific component from the blood. The present invention relates to a plasma extraction kit that is easy to disinfect and convenient.
일반적으로, 혈액 속에 있는 혈구세포들은 비중이 서로 다른 성분이 혼합되어 있는 상태인데, 이를 원심분리 하게 되면 각각 종류별로 층을 이루어 모이게 된다.In general, blood cells in the blood are mixed with different specific gravity components, when centrifuged to form a layer by each type.
최근, 혈액에 소량으로 들어있는 혈소판이 조직의 재생에 탁월한 효과를 발휘한다는 사실이 알려지면서 퇴행성 변화로 인해 마모된 조직에 고농도로 농축된 혈소판 혈장을(PRP, Platelet Rich Plasma 혈소판 풍부 혈장, 이하 'PRP'라 한다) 투여함으로서 조직을 재생하는 치료방법이 많이 시도되고 있으며, 피부미용 및 피부 치료에도 적용되는 등 PRP투여는 여러 분야에서 응용되고 있는 치료방법이다.Recently, platelet rich plasma (PRP, Platelet Rich Plasma Platelet Rich Plasma, or 'PRP') has been known to be known for its excellent effect on tissue regeneration. PRP administration is a treatment method that is applied in many fields, such as applied to skin care and skin treatment.
혈소판이 재생효과를 나타내는 이유는 혈소판 세포 내에는 성장인자가 풍부하게 함유 되어있기 때문이다. 고농도의 혈소판을 치료부위에 주입하게 되면 혈소판의 성장인자들이 줄기세포를 활성화시켜 손상된 조직을 다시 생성하도록 하게 한다. PRP의 농축율이 높을수록 치료효과는 증대된다.Platelets have a regenerative effect because platelet cells contain abundant growth factors. Injecting high levels of platelets into the treatment area causes platelet growth factors to activate stem cells to regenerate damaged tissue. The higher the concentration of PRP, the greater the therapeutic effect.
일반적인 PRP 추출 과정은 먼저 인체에서 혈액을 채혈하여 원심분리한다. 혈액 속에는 여러 세포들이 혼재되어 있는데 원심분리를 하게 되면 동종의 세포들끼리 모이게 되고 비중에 따라 각각 층을 이루게 된다. 혈액의 구성은 용액성분과 혈구성분(알갱이 세포)으로 되어 있는데 혈구 성분에는 적혈구, 백혈구, 혈소판 및 극소량의 항체들이 있으며, 이러한 혈구 세포들이 0.9%의 염도를 가진 용액 속에서 섞여서 떠다니고 있다. 이중 혈구성분의 대부분을 차지하는 것은 적혈구이다.The general PRP extraction process first collects blood from the human body and centrifuges it. Several cells are mixed in the blood. When centrifuged, homogeneous cells are collected and layered according to specific gravity. The blood consists of a solution component and a blood cell component (grain cell), which contains red blood cells, white blood cells, platelets, and a very small amount of antibodies, which are mixed and floated in a solution with 0.9% salinity. Red blood cells constitute the majority of the blood cell components.
혈액을 원심분리하면 3개 층으로 분리가 되는데 비중이 가장 무거운 적혈구들는 원심 분리관의 제일 하부에 모이게 되고, 그 바로 윗층에 혈소판 및 백혈구들이 모여 얇은 층을 이루게 되며, 그 위쪽으로 나머지 알갱이가 거의 없는 용액 성분들이 위치하게 된다. 혈소판 및 백혈구들이 집중적으로 모여있는 가운데 얇은층을 PRP이라 명명하며 그 위쪽의 혈구 알갱이가 없이 용액으로만 이루어진 혈장층을 PPP(Platelet Poor Plasma, 혈소판 결핍 혈장, 이하 'PPP'라 한다)라고 명명한다.When the blood is centrifuged, it is separated into three layers. The heaviest red blood cells are collected at the bottom of the centrifuge tube, and platelets and leukocytes are gathered on the upper layer to form a thin layer. Missing solution components are placed. The platelet and leukocytes are concentrated together, and the thin layer is called PRP, and the plasma layer composed only of solution without blood cell granules above is called PPP (Platelet Poor Plasma). .
이중 PRP층을 선별추출하기 위한 여러 기구들, 방법들이 제안되었다.Several instruments and methods have been proposed for screening double PRP layers.
[선행기술문헌][Preceding technical literature]
(특허문헌 1) 한국등록특허 제1016166호(자가 혈소판 농축물질 분리방법)(Patent Document 1) Korean Registered Patent No. 1016166 (Method for separating autologous platelet concentrate)
(특허문헌 2) 한국등록특허 제1043231호(원심분리방법 및 이에 사용되는 어댑터)(Patent Document 2) Korean Registered Patent No. 1043231 (centrifugal separation method and adapter used therein)
(특허문헌 3) 한국등록특허 제1029255호(원심분리장치)(Patent Document 3) Korean Registered Patent No. 1029255 (centrifugal separator)
그러나, 종래의 PRP추출방법에 의하면, 순도 높은 PRP추출이 그리 용이하지 않다는 문제점이 있었다. However, according to the conventional PRP extraction method, there is a problem that high purity PRP extraction is not easy.
즉, 포함되지 않아야 할 적혈구가 포함되어 추출되는 문제가 있고, 추출하는 과정이 매우 정밀하여 추출자에 따라서 PRP의 농도가 일정하지 않아 정도 관리상의 편차가 있으며, 추출과정이 섬세한 조작을 필요하다 보니 시간이 많이 소모되고, 추출된 PRP의 농축율을 필요에 따라 고농도에서 저농도까지 자유롭게 조절하기 어려운 문제가 있으며, 기존의 PRP 추출용 원심분리관의 가격이 매우 고가인 문제들이 있다.That is, there is a problem that red blood cells are included, which should not be included, and the extraction process is very precise, so that the concentration of PRP is not constant according to the extractor, resulting in deviations in the degree of control, and the extraction process requires delicate manipulation. It takes a lot of time, there is a problem that it is difficult to freely control the concentration of the extracted PRP from high concentration to low concentration, there is a problem that the price of the conventional PRP extraction centrifuge tube is very expensive.
혈액을 원심분리 하면, PRP는 아주 얇은 두께를 가진 층으로 나타나며, 바로 아래의 적혈구 층 전체에 얇고 넓게 도포되어 있는 모습으로 보이게 되고, 제일 하부에 모이게 되는 적혈구층의 두께는 사람에 따라 다른데, 적혈구가 혈액 전체의 용적에서 차지하는 비율이 적게는 25%에서 많게는 50%까지 넓은 편차를 보이고 있기 때문에, 순도높은 PRP를 추출하기가 용이하지 않게 된다.When the blood is centrifuged, the PRP appears as a very thin layer, which appears to be thin and widely spread over the entire red blood cell layer directly below, and the thickness of the red blood cell that is collected at the bottom is different depending on the person. Since the ratio of the total volume of the whole blood varies from as little as 25% to as much as 50%, it is not easy to extract high purity PRP.
적혈구층 최상단 위에 얇게 퍼져있는 PRP를 추출하기 위해서는 시험관 안으로 니들을 넣고 니들의 끝부분을 PRP층에 닿게 하여 흡입하는 방식으로 추출하게 되는데 이때 적혈구층의 상단부위를 긁어가며 추출할 수 밖에 없다. 이 과정에서 적지 않은 적혈구들이 PRP와 함께 빨려 들어오게 되고, 이 적혈구들은 환자에게 시술할 때 PRP와 함께 조직에 주입되게 된다. In order to extract PRP thinly spread on the top of the erythrocyte layer, the needle is inserted into the test tube, and the tip of the needle touches the PRP layer and is extracted by inhaling it. In the process, a significant number of red blood cells are sucked in with the PRP, and these red blood cells are injected into the tissue along with the PRP when the patient is treated.
PRP에 빨려 들어온 적혈구들은 두 가지 문제를 야기하는데 첫 번째는 그 적혈구 양이 많을수록 PRP의 농축율이 저하되어 치료효과를 떨어뜨리게 되며, 두 번째는 시술 후 환자들이 시술부위에 격심한 통증을 호소하는 원인이 된다. 순수한 PRP를 주입해도 치료 후에 통증이 어느 정도 동반되는데 짧게는 1일, 길게는 1주일까지도 지속 되며 심할 경우 마약성 진통제를 투여해야 하는 경우도 있다. 이때 적혈구들이 같이 주입되게 되면 통증은 더욱 심해지게 된다. 이러한 이유로 PRP 추출시 가능한 한 적혈구가 포함되지 않도록 하기 위해 여러 방법들을 동원하고 있는데 가장 일반적으로 쓰이는 방법이 PRP층이 형성될 것으로 예측되는 부분의 원심분리관 직경을 작게 만들어 줄어든 단면적에 비례하여 PRP가 두껍게 쌓이게 하여 적혈구층과 접촉하는 면적을 줄인 뒤 추출하는 방식을 택하고 있다. 이러한 방법을 사용할 때 한가지 문제점이 있는데, 서로 다른 사람에게서 동일한 양의 혈액을 채혈하여 원심관에 넣어 원심분리 하더라도 상술한 바와 같이 적혈구의 양이 사람마다 다름으로 인해 하부 적혈구층의 두께가 다르게 나타난다. 따라서 PRP가 형성될 것으로 예측한 부위에 원심분리 후 PRP가 실제로 위치하게 되는 경우는 거의 없다.Erythrocytes sucked into PRP cause two problems. First, the higher the amount of red blood cells, the lower the concentration of PRP, which lowers the therapeutic effect. Second, the patients complain of severe pain after the procedure. Cause. Even with pure PRP, there is some pain after treatment, which lasts as long as 1 day and as long as 1 week. In some cases, narcotic analgesics may be required. When the red blood cells are injected together, the pain becomes more severe. For this reason, several methods are used to prevent the inclusion of red blood cells in PRP extraction. The most commonly used method is to reduce the diameter of the centrifuge tube in the area where the PRP layer is expected to form and to reduce the proportion of PRP. By stacking thicker to reduce the area in contact with the erythrocyte layer is taking a way to extract. When using this method, there is one problem. Even when the same amount of blood is collected from different people and centrifuged into a centrifuge tube, the thickness of the lower red blood cell layer is different due to the different amount of red blood cells as described above. Therefore, the PRP is rarely actually located after centrifugation at the site where the PRP is expected to form.
그래서 분리장치 하부의 적혈구층의 높이를 조절하여 PRP를 직경이 좁은 넥부위에 위치하도록 해주는 보정 장치가 수반되어야 하는데 통상 원심분리관의 하부에 나사 형태로 되어있는 마개를 상황에 따라 잠금 방향이나 푸는 방향으로 돌리면서 적혈구층의 높낮이를 조절하게 된다. 그런데 이러한 방식의 원심분리관은 3000-4000RPM의 고속회전시 원심관 하부에는 혈액의 엄청난 탈출 압력이 걸리게 되어 나사부위를 통하여 혈액이 흘러나올 수 있는 가능성이 있다. 이때문에 누액 방지를 위한 추가 부품들과 정밀한 구조 제작이 필요하게 되고 이는 제작단가 상승으로 이어져 원심분리관의 가격이 고가가 될 수밖에 없으며 결과적으로 최종 치료금액도 높아지게 된다. 그리고 이렇게 고안된 추출 장치들도 실제 임상에서 사용해 보면 넥 부분의 길이가 짧아서 PRP를 이 부분에 정확히 위치하게 하는 것이 상당히 어려우며 하부의 나사장치를 돌려 층을 이동하는 과정에서 PRP층이 어느 정도 흩어져 버리는 결과를 초래한다.Therefore, a correction device that adjusts the height of the red blood cell layer in the lower part of the separator to position the PRP in the narrow neck portion should be accompanied. Usually, a screw-shaped stopper in the lower part of the centrifuge tube may be locked or released depending on the situation. Rotating in the direction to control the height of the red blood cell layer. By the way, the centrifuge tube of this type has a great escape pressure of blood in the lower part of the centrifuge tube during the high-speed rotation of 3000-4000RPM, and there is a possibility that blood can flow out through the screw part. For this reason, it is necessary to manufacture additional parts and precise structure to prevent leakage, which leads to an increase in manufacturing cost, which inevitably increases the price of the centrifuge tube, resulting in a higher final treatment amount. And the extraction devices designed like this have a short neck length so that it is very difficult to accurately place the PRP in this part.The result is that the PRP layer is scattered to some extent in the process of moving the layer by rotating the lower screw device. Results in.
또한, PRP를 추출하는 종래의 방법으로는, 한국실용신안등록 20-0273082호에 기재된 바와 같이, 혈청분리용 주사기를 사용하는 방법이 개시되어 있다. In addition, as a conventional method of extracting PRP, a method of using a syringe for serum separation is disclosed, as described in Korean Utility Model Registration No. 20-0273082.
상기 종래기술에 의하면, 상부로 피스톤이 이동 가능하게 삽입되며, 하부에는 주사바늘이 고정되는 바늘연결구가 형성되고, 내부에는 혈액과 혈청을 분리하는 혈청분리용 겔이 일정량 충진되는 실린더와; 실린더의 하부에 형성되는 바늘연결구 상부로 돌출 되면서 실린더의 내부에 형성되어 주사기의 내부에 충진되는 혈청분리용 겔이 주사바늘이 고정되는 바늘연결구 쪽으로 배출되지 않도록 하는 돌출부와; 주사바늘이 고정되는 실린더의 바늘연결구에서 주사바늘이 제거될 때 바늘연결구의 하부에 고정되며, 바늘연결구를 밀폐시키는 밀폐구가 상부로 돌출되게 형성되는 하부마개와; 실린더에 이동 가능하게 고정되는 피스톤이 제거될 때 실린더의 개구된 상부에 고정되며, 실린더와 밀착되는 면에 다수개의 밀착구가 형성되는 상부마개를 포함하여 이루어지는 혈청분리용주사기가 개시되어 있다. According to the prior art, a piston is inserted into the upper part to be movable, the lower portion is formed with a needle connector is fixed to the needle, the inside is filled with a certain amount of serum separation gel for separating blood and serum therein; A protrusion which protrudes above the needle connector formed in the lower portion of the cylinder and is formed inside the cylinder so that the serum separation gel filled in the syringe is not discharged toward the needle connector where the needle is fixed; A lower stopper which is fixed to the lower part of the needle connector when the needle is removed from the needle connector of the cylinder to which the needle is fixed, and a seal which seals the needle connector protrudes upward; When the piston movably fixed to the cylinder is removed is fixed to the open top of the cylinder, a serum separation syringe comprising an upper stopper is formed on the surface in close contact with the cylinder is formed.
상기 종래기술에 의하면, 혈액을 실린더에 일정량 주입한 후, 상부마개에 의해 실린더를 밀봉시키는 구조를 갖는다. According to the prior art, after a certain amount of blood is injected into the cylinder, the cylinder is sealed by an upper cap.
한편, 혈액분리용 주사기나 혈장추출키트 및 혈액추출에 사용되는 주사기 등 의료기기는 추출된 혈액에 균이 침투하지 않도록 무균 및 멸균 처리는 물론 밀봉성이 매우 중요한 요소이다. On the other hand, medical devices such as blood separation syringes, plasma extraction kits and syringes used for blood extraction are very important factors as well as sterilization and sterilization so that bacteria do not penetrate the extracted blood.
이러한 의료기기 등의 소독방법으로는, 고온의 스팀에 의해 멸균하는 방법과, EO가스를 투입하여 멸균하는 방법과, 감마선을 조사하여 멸균하는 방법이 주로 사용되고 있다. 고온의 스팀에 의해 멸균하는 방법의 경우, 플라스틱 제품 등에 적용하기 곤란하다는 문제점이 있을 뿐만 아니라 밀봉상태에서 멸균하기 어렵다고 하는 문제점이 있으며, EO가스를 투입하여 멸균하는 방법도 의료기기가 공장에서 밀폐된 상태로 출시되므로 의료기기 내부를 소독하기 어려우며, 감마선을 조사하는 멸균방식도 플라스틱 제품에 적용할 수는 있으나 감마선을 견디게 하기 위하여 특수 처리를 하여야 하므로, 플라스틱 제품에 적용하기 어렵고 제조비용이 고가로 된다고 하는 문제점이 있었다. As a disinfection method of such a medical device, a method of sterilization by high temperature steam, a method of sterilizing by adding EO gas, and a method of sterilizing by irradiating gamma rays are mainly used. In the case of sterilization by high temperature steam, not only is it difficult to apply to plastic products, but also has a problem of being difficult to sterilize in a sealed state. It is difficult to disinfect the inside of medical devices because it is released in the state, and the sterilization method that irradiates gamma rays can be applied to plastic products, but it is difficult to apply to plastic products and the manufacturing cost becomes expensive because special treatment must be performed to endure gamma rays. There was a problem.
본 발명은 상술한 종래기술의 문제점을 해결하고자 하는 것으로서, 본 발명의 목적은 공장에서 제조되는 주사기나 혈장추출키트가 밀봉된 상태에서 소독이 가능할 뿐만 아니라, 환자로부터 추출한 혈액을 키트에 주입할 때에 오염의 염려가 적고 주입 및 밀봉이 용이한 혈장추출키트를 제공하는 것이다. The present invention is to solve the above-mentioned problems of the prior art, an object of the present invention is not only capable of disinfection in a sealed syringe or plasma extraction kit manufactured at the factory, but also when injecting the blood extracted from the patient into the kit It is to provide a plasma extraction kit that is less concerned about contamination and easy to inject and seal.
또한, 본 발명의 다른 목적은 추출된 PRP가 순도성과 농축율은 증가되고, 추출 조작의 용이성은 더 개선되며, 제작단가는 경감될 수 있는 혈장추출키트를 제공하는 것이다. In addition, another object of the present invention is to provide a plasma extraction kit in which the extracted PRP is increased in purity and concentration, the ease of extraction operation is further improved, and the manufacturing cost can be reduced.
상술한 목적을 달성하기 위하여, 본 발명에 의한 혈장추출키트는, 상단이 개구되고 하단이 폐쇄되어 있는 원통형 형상의 본체부와, 상기 본체부의 내부 중앙부분에 체결되며, 중앙부의 직경이 작고 양단부는 중앙부를 향하여 직경이 점차 감소하는 테이퍼 형상으로 형성된 깔대기부와, 상기 본체부의 상단을 폐쇄하는 덮개부를 구비하는 것을 특징으로 한다. In order to achieve the above object, the plasma extraction kit according to the present invention, the upper end is opened and the lower end is closed with a cylindrical body portion, and fastened to the inner central portion of the main body portion, the diameter of the central portion is small and both ends It characterized in that it comprises a funnel portion formed in a tapered shape that gradually decreases in diameter toward the central portion, and a cover portion for closing the upper end of the main body portion.
또한, 본 발명은 혈액으로부터 혈장 성분을 추출하는 혈장 추출 키트에 의해 주입된 혈액을 1차로 원심분리한 후 원심분리된 혈액의 PPP와 적혈구로부터 2차 원심분리에 의해 혈장을 더욱 추출하는 2차 원심분리관을 포함하여 구성되는 것을 특징으로 한다. In addition, the present invention is the second centrifugal to further extract the plasma by the second centrifugation from the PPP and erythrocytes of the centrifuged blood after the first centrifugation of the blood injected by the plasma extraction kit for extracting the plasma components from the blood Characterized in that comprises a separator tube.
상술한 구성을 가지는 본 발명에 의하면, 순도 높은 고농도의 PRP를 용이하게 추출할 수 있고, 추출 과정에서 적혈구를 거의 배제하고 추출할 수 있으며, 조작자에 따른 정도 편차가 적고 추출시간을 단축할 수 있으며, 원심분리관의 제작단가를 낮추어 시술자들의 치료비용을 경감시킬 수 있는 장점이 있다. 원심분리후에 혈액성분 중 다량인 적혈구는 혈액저장부에 수용되고, 소량인 PRP는 직경이 작은 깔대기부의 중앙에 수용할 수 있으므로, 소량인 PRP의 추출을 용이하게 할 수 있다. According to the present invention having the above-described configuration, it is possible to easily extract a high-purity high concentration of PRP, can be extracted by almost eliminating red blood cells in the extraction process, the degree of variation is small according to the operator and the extraction time can be shortened By lowering the manufacturing cost of the centrifuge tube, there is an advantage that can reduce the treatment cost of the operators. After centrifugation, a large amount of red blood cells in the blood component is accommodated in the blood storage unit, and a small amount of PRP can be accommodated in the center of the funnel having a small diameter, thereby facilitating extraction of a small amount of PRP.
또한, 사람에 따라 적혈구의 양이 다르다 하더라도 상기 깔대기부의 위치를 조정할 수 있으므로, 상기 깔대기부에 PRP를 정확하게 위치시킬 수 있고, 이로써 순도 높은 고농도의 PRP를 용이하게 추출할 수 있고, 추출 과정에서 적혈구를 거의 배제하고 추출할 수 있으며, 조작자에 따른 정도 편차가 적고 추출시간을 단축할 수 있으며, 원심분리관의 제작단가를 낮추어 시술자들의 치료비용을 경감시킬 수 있는 장점이 있다.In addition, even if the amount of red blood cells differs from person to person, since the position of the funnel can be adjusted, the PRP can be accurately positioned in the funnel, thereby easily extracting high-purity PRP with high purity and red blood cells in the extraction process. The extraction can be almost excluded, and the degree of variation according to the operator is small, the extraction time can be shortened, and the manufacturing cost of the centrifuge tube can be lowered to reduce the treatment cost of the operators.
도 1은 종래기술의 혈장추출키트를 나타내는 도면, 1 is a view showing a plasma extraction kit of the prior art,
도 2는 본 발명의 제 1 실시예에 의한 혈장 추출 키트를 나타내는 도면,2 is a view showing a plasma extraction kit according to a first embodiment of the present invention,
도 3은 제 1 실시예의 혈장추출키트의 사시도 및 단면도,3 is a perspective view and a cross-sectional view of the plasma extraction kit of the first embodiment,
도 4는 제 1 실시예의 혈장추출키트의 내부에 삽입하는 깔대기부의 사시도 및 단면도,4 is a perspective view and a cross-sectional view of the funnel to be inserted into the plasma extraction kit of the first embodiment,
도 5는 1차 원심분리 후 나타나는 혈액층의 단면도,5 is a cross-sectional view of the blood layer after the first centrifugation,
도 6은 1차 PRP 및 PPP 추출하는 모습을 보여주는 단면도,6 is a cross-sectional view showing the first PRP and PPP extraction;
도 7은 1차 원심분리 후 적혈구 과다 혈액의 모습을 보여주는 단면도, 7 is a cross-sectional view showing the appearance of excess red blood cells after the first centrifugation;
도 8은 1차 원심분리 후 적혈구 과소 혈액의 모습을 보여주는 단면도, Figure 8 is a cross-sectional view showing the appearance of red blood cells under the first centrifugation,
도 9는 2차 원심분리관의 사시도 및 단면도,9 is a perspective view and a cross-sectional view of the secondary centrifuge tube,
도 10은 2차 원심분리 후 나타나는 혈액층의 단면도,10 is a cross-sectional view of the blood layer after secondary centrifugation,
도 11은 상층의 PPP를 추출하는 모습을 보여주는 단면도,11 is a cross-sectional view showing the extraction of the PPP of the upper layer,
도 12는 남은 소량의 PPP, PRP, 소량의 적혈구를 보여주는 단면도,12 is a cross-sectional view showing a small amount of remaining PPP, PRP, small amount of red blood cells,
도 13은 최종적인 PRP를 추출하는 모습을 보여주는 단면도, 13 is a cross-sectional view showing a state of extracting the final PRP,
도 14는 본 발명의 제 2 실시예에 의한 혈장추출키트를 나타내는 사시도,14 is a perspective view showing a plasma extraction kit according to a second embodiment of the present invention,
도 15는 도 14의 절개사시도, FIG. 15 is a cutaway perspective view of FIG. 14; FIG.
도 16은 본 발명의 제 2 실시예에 의한 혈장추출키트의 단면도,. 16 is a cross-sectional view of the plasma extraction kit according to a second embodiment of the present invention.
도 17 및 도 18은 본 발명의 제 2 실시예에 의한 혈장추출키트의 외통을 나타내는 도면,17 and 18 are views showing the outer cylinder of the plasma extraction kit according to a second embodiment of the present invention,
도 19는 본 발명의 제 2 실시예에 의한 혈장추출키트의 개폐 캡을 나타내는 도면, 19 is a view showing the opening and closing cap of the plasma extraction kit according to a second embodiment of the present invention,
도 20은 본 발명의 제 2 실시예에 의한 혈장추출키트의 덮개부를 나타내는 도면, 20 is a view showing a cover portion of the plasma extraction kit according to a second embodiment of the present invention,
도 21은 본 발명의 제 2 실시예에 의한 혈장추출키트의 연결날개부를 나타내는 도면, 21 is a view showing the connection blade portion of the plasma extraction kit according to a second embodiment of the present invention,
도 22는 본 발명의 제 2 실시예에 의한 혈장추출키트의 사용예를 나타내는 도면이다. 22 is a diagram showing an example of use of the plasma extraction kit according to the second embodiment of the present invention.
본 발명에 의한 혈장추출키트는, 상단이 개구되고 하단이 폐쇄되어 있는 원통형 형상의 본체부와, 상기 본체부의 내부 중앙부분에 체결되며, 중앙부의 직경이 작고 양단부는 중앙부를 향하여 직경이 점차 감소하는 테이퍼 형상으로 형성된 깔대기부와, 상기 본체부의 상단을 폐쇄하는 덮개부를 구비하는 것을 특징으로 한다. Plasma extraction kit according to the present invention, the upper end is opened and the lower end is closed, the main body portion is fastened to the inner central portion of the main body portion, the diameter of the center portion is small and both ends are gradually reduced in diameter toward the center portion A funnel formed in a tapered shape, and a cover portion for closing the upper end of the main body portion.
여기서, 상기 본체부의 내측면에는 상기 깔대기부를 일정 위치에 유지하도록 이탈을 방지하는 걸림턱이 형성되어 있는 것을 특징으로 한다.Here, the inner side of the main body portion is characterized in that the locking step is formed to prevent the separation to maintain the funnel in a predetermined position.
상기 덮개부에 개폐가능하게 체결되며, 환자로부터 추출한 혈액을 주입하는 주사기의 주사바늘이 삽입될 수 있는 주입홀을 일측면에 구비한 개폐 캡을 구비하는 것을 특징으로 한다. The opening and closing is fastened to the cover portion, characterized in that it comprises an opening and closing cap having an injection hole on one side that can be inserted into the needle of the syringe for injecting blood extracted from the patient.
여기서, 상기 개폐 캡은, 상부면 중앙에 형성된 개구를 폐쇄하며, 원심분리된 혈액의 다혈소판 혈장을 추출하기 위한 주사기가 용이하게 삽입될 수 있는 재질로 형성된 밀폐막을 더욱 구비하는 것을 특징으로 한다. Here, the opening and closing cap, and closes the opening formed in the center of the upper surface, characterized in that it further comprises a sealing membrane formed of a material that can be easily inserted into the syringe for extracting the multi-platelet plasma of the centrifuged blood.
상기 덮개부는 중앙에 체결홀이 형성되고, 상기 체결홀로부터 돌출되는 돌출부를 구비하며, 상기 개폐 캡은, 하부끝단으로부터 외측으로 돌출되어 상기 덮개부의 돌출부에 걸림고정되는 걸림돌기를 구비하는 것을 특징으로 한다. The cover part has a fastening hole formed at the center thereof, and includes a protrusion projecting from the fastening hole, and the opening / closing cap is provided with a locking protrusion projecting outward from the lower end to be locked to the protrusion of the cover part. .
상기 깔대기부의 하부에 마련되며 상기 본체부의 내부 하단에 설치되어 주입되는 혈액을 수용하는 혈액저장부를 더욱 구비하는 것을 특징으로 한다. It is provided on the lower portion of the funnel, characterized in that it further comprises a blood storage unit for receiving the blood is installed is installed in the inner bottom of the main body portion.
상기 깔대기부는, 중앙부분의 직경이 작고 양단부분은 중앙부분을 향하여 직경이 점차 감소하는 테이퍼 형상으로 형성된 내통과, 상하부가 개구되고 상기 내통의 양단부가 체결되는 중공의 원통형상으로 형성된 외통으로 형성되는 것을 특징으로 한다. The funnel is formed of an inner cylinder formed in a tapered shape in which the diameter of the center portion is small and both ends thereof are tapered in diameter gradually decreasing toward the center portion, and an outer cylinder formed in a hollow cylindrical shape in which upper and lower portions are opened and both ends of the inner cylinder are fastened. It is characterized by.
여기서, 상기 외통은 외측으로 돌출된 체결돌기가 형성되어 있고, 상기 본체부의 내측면에는 내측으로 오목하게 절개되며 일정 폭을 구비하여 상기 체결돌기가 삽입되며 상기 체결돌기의 이동을 제한하는 체결홈이 형성되어 있는 것을 특징으로 한다. Here, the outer cylinder is formed with a fastening protrusion protruding outward, the inner surface of the main body portion is indented concave inwardly and has a predetermined width, the fastening protrusion is inserted into the fastening groove for limiting the movement of the fastening protrusion is It is characterized by being formed.
여기서, 일끝단은 상기 깔대기부에 연결되고 타끝단은 절곡되어 상기 덮개부의 나사산에 맞물리는 체결돌기가 형성된 기다란 막대형상의 연결날개부를 더욱 구비하는 것을 특징으로 한다. Here, one end is connected to the funnel and the other end is bent and characterized in that it further comprises an elongated rod-shaped connecting blade formed with a fastening projection engaging the thread of the cover portion.
여기서, 상기 연결날개부는, 일끝단에 T자 형상으로 형성된 제 1 날개부와, 타끝단에 상기 덮개부에 형성된 체결나사에 체결되는 연결돌기를 구비하는 것을 특징으로 한다. Here, the connection blade portion is characterized in that it comprises a first wing portion formed in a T-shape at one end, and a connecting projection fastened to the fastening screw formed on the cover portion at the other end.
여기서, 상기 외통의 상단부분에는 T자 형상으로 절개되어 형성되며 상기 제 1 날개부가 체결되는 걸림고정홈을 더욱 구비하는 것을 특징으로 한다.Here, the upper end portion of the outer cylinder is formed by cutting in a T-shape and characterized in that it further comprises a locking groove that is fastened to the first wing portion.
또한, 혈액으로부터 혈장 성분을 추출하는 혈장 추출 키트에 의해, 주입된 혈액을 1차로 원심분리한 후 원심분리된 혈액의 PRP와 PPP와 적혈구로부터 2차 원심분리에 의해 혈장을 더욱 추출하는 2차 원심분리관을 더욱 포함하여 구성되는 것을 특징으로 한다. In addition, by the plasma extraction kit for extracting the plasma components from the blood, the second centrifugal centrifugation to further extract the plasma from the PRP, PPP and erythrocytes of the centrifuged blood by centrifugation of the injected blood first Characterized in that further comprises a separation tube.
상기 2차 원심분리관은 원통형 형상으로 형성되어 있고, 상기 2차 원심분리관의 하단부에는 상부보다 직경이 작은 제 2 모세관과, 상기 제 2 모세관의 끝단부분에는 직경이 점차 작아지는 첨단부가 형성되어 있는 것을 특징으로 한다. The secondary centrifuge tube is formed in a cylindrical shape, the lower end of the secondary centrifuge tube is formed with a second capillary tube having a smaller diameter than the upper portion, the tip portion of the second capillary tube is gradually reduced in diameter is formed It is characterized by being.
이하, 첨부된 도면을 참조하여 본 발명에 의한 혈장 추출 키트에 대하여 실시예로써 상세하게 설명한다. Hereinafter, with reference to the accompanying drawings will be described in detail with respect to the plasma extraction kit according to the present invention.
<실시예 1><Example 1>
도 2 내지 도 13은 본 발명의 제 1 실시예에 의한 혈장추출키트를 나타내는 도면이다. 2 to 13 is a view showing a plasma extraction kit according to a first embodiment of the present invention.
도 2 내지 도 13에 나타난 바와 같이, 본 실시예에 의한 혈장추출키트(1)는 모양이 다른 두 개의 원심관 실린더로 제공이 되며, 각각 본체부, 2차 원심분리관으로 사용되며, 각각의 모양이 추출과정에서 용이하게 사용되도록 고안된 상태로 제공된다.As shown in Figures 2 to 13, the plasma extraction kit 1 according to the present embodiment is provided as two centrifuge tube cylinders of different shapes, respectively, used as a main body portion, secondary centrifuge tube, each The shape is provided as designed to be easily used in the extraction process.
상기 본체부와 후술하는 2차 원심분리관의 입구는 덮개(40, 40')에 의해 밀폐되고, 덮개의 중앙부위는 주사바늘이 들어갈 수 있는 천공 구멍(42, 42')이 형성되어있고, 상부 덮개를 분리하지 않고 상기 천공구멍을 통해 주사바늘을 삽입하여 혈액을 주입할 수 있도록 구성되어 있으며, 외부 감염으로부터 안전하도록 상기 덮개는 연질의 탄성 재질로 형성되어 있다.The inlet of the main body and the secondary centrifuge tube, which will be described later, is closed by lids 40 and 40 ', and the central portion of the lid is formed with perforations 42 and 42' through which a needle can enter. It is configured to inject blood by inserting a needle through the drilling hole without removing the upper cover, the cover is formed of a soft elastic material to be safe from external infection.
상술한 덮개는 본체부 내부로 삽입되는 부분이 있는데 그 표면은 나사산(41, 41')이 형성되어 있다.The above-described cover has a portion to be inserted into the main body portion, the surface of which is formed with threads 41 and 41 '.
본체부의 내부에는 원통 형상으로 형성된 깔대기부(20)가 삽입되어 있으며 깔대기부(20)의 중앙에는 상기 깔대기부의 상부와 하부를 관통하는 길고 좁은 직경의 모세관(23)이 형성되어 있다. 이 모세관의 위쪽과 아래쪽 끝부분에서는 직경이 점점 좁아지거나 점차 넓어지는 깔대기 모양의 테이퍼부(21,22)가 형성되어 있고, 상기 본체부와 상기 깔대기부는 투명한 재질로 형성되어 외부에서 내부 모세관에 있는 혈액 성분을 선명하게 볼 수 있다. 삽입된 상기 깔대기부는 본체부의 내경과 정확하게 외접하여 밀착된 상태로 제공된다. 깔대기 모양의 테이퍼부의 경사는 상부와 하부가 각각 다르게 설계되어 있다.A funnel portion 20 formed in a cylindrical shape is inserted into the main body portion, and a capillary tube 23 having a long narrow diameter penetrating the upper and lower portions of the funnel portion is formed in the center of the funnel portion 20. The upper and lower ends of the capillary are formed with funnel-shaped tapered portions 21 and 22 that are narrower or wider in diameter, and the main body and the funnel are formed of a transparent material and are located in the inner capillary from the outside. Blood components can be seen clearly. The inserted funnel is provided in close contact with the inner diameter of the main body portion accurately. The inclination of the funnel-shaped taper is designed differently for the upper and lower parts.
상술한 상기 깔대기부의 상단부에는 두 개의 폭이 좁고 긴 막대기 형태의 연결날개부(24)가 위로 뻗어있는데 상기 덮개까지 이르고 있으며 그 끝은 내측으로 절곡되어 체결돌기(25)가 형성되어 덮개 하단부의 나사산(26)에 물릴 수 있는 상태로 제공된다.In the upper end of the funnel portion, two narrow, long rod-shaped connecting wings 24 extend upward, leading to the cover, the end of which is bent inward to form a fastening protrusion 25 to form a screw thread at the bottom of the cover. It is provided in a state capable of being bitten by 26.
상기 덮개(40)를 돌리게 되면 상기 연결날개부에 연결된 하부의 상기 깔대기부가 덮개의 나사산을 따라 상하 운동을 하면서 높이가 변하게 된다. 덮개의 측면은 회전시 마찰력을 높이기 위해 요철(43)로 되어있다When the cover 40 is rotated, the funnel portion of the lower portion connected to the connecting wing part is changed in height while moving up and down along the thread of the cover. The side of the cover is made of irregularities (43) to increase the friction force during rotation
상기 깔대기부는 덮개에 날개로 연결되어 있을 때 본체부의 바닥면까지 내려와 있지 않고 중간에 떠있는 상태이다. 상기 깔대기부가 위치하는 부분의 실린더 상단, 하단에는 일정 거리만큼 간격을 두고 걸림턱(27)이 만들어져 있어 원통구조물이 바닥에 닿거나 위로 빠져나오지 못하도록 한계를 두고 있는 상태로 제공된다.When the funnel is connected to the cover by a wing, it is floating in the middle without descending to the bottom of the main body. The top and bottom of the cylinder of the portion where the funnel is located is provided with a locking jaw 27 is spaced by a predetermined distance so that the cylindrical structure does not reach the floor or come out of the upper limit.
상기 깔대기부의 하부 공간은 원심분리시 적혈구가 모이는 공간이며 각 사람의 적혈구 양의 다양성을 계산하여 적절한 용량의 공간을 확보하는 혈액저장부(30)이다.The lower space of the funnel portion is a space in which red blood cells are collected during centrifugation, and the blood storage unit 30 calculates the diversity of red blood cells of each person and secures a space of appropriate capacity.
2차 원심분리관(2)은 대략 원통형 형상으로 형성되어 있고, 그 하단부에는 상부보다 직경이 작은 좁은 제 2 모세관(71)이 형성되어 있으며, 상기 제 2 모세관(71)의 끝단부분에는 원뿔형으로 되어 직경이 더 작아지다가 끝은 꼭지점으로 끝나는 첨단부(72)가 형성되어 있다.The secondary centrifuge tube (2) is formed in a substantially cylindrical shape, the lower end of which is formed a narrow second capillary tube (71) having a smaller diameter than the upper portion, and the end of the second capillary tube (71) is conical. As the diameter becomes smaller, the tip portion 72 is formed which ends at the vertex.
PRP를 추출하기 위한 원심분리는 통상적으로 2차례를 실시한다. 1차 원심분리 후 상층의 혈장과 하층의 적혈구 비율을 측정하고 그 위치를 조절한 뒤 2차 원심분리를 실시하는데 지금까지 개발된 제품들은 일체형 원심관에서 2차례 모두 실행하고 있다. 본 실시예에 의한 혈장 추출 키트는 1차 원심분리와 2차 원심분리를 각기 다른 원심분리관에서 시행하는 것이 특징이다.Centrifugation to extract the PRP is usually carried out twice. After the first centrifugation, the ratio of the upper plasma and the lower red blood cells is measured, and the position is adjusted. Then, the second centrifugation is performed. The products developed so far are performed twice in an integrated centrifuge tube. The plasma extraction kit according to the present embodiment is characterized in that the first centrifugation and the second centrifugation are performed in different centrifuge tubes.
상술한 바와 같이, 사람의 적혈구의 양은 각각 다르므로 이 편차의 범위를 수용해서 수월한 추출을 하도록 고안된 것이 본 실시예의 혈장추출키트(1)이다.As described above, since the amount of human red blood cells is different, the plasma extraction kit 1 of the present embodiment is designed to accommodate the range of this deviation and facilitate extraction.
혈장추출키트(1)는 위에서부터 상부공간(10), 깔대기부(20), 혈액저장부(30)로 나뉘어진다. 원심분리 후 상부공간(10)은 혈장이 모이는 구간이고, 혈액저장부(30)는 적혈구가 모이는 공간이며, 깔대기부(20)는 두 층의 경계부위를 이루도록 설계되어있다. 깔대기부의 상단(21)과 하단이 직경이 점차 작아지거나 점차 커지는 깔대기 모양의 테이퍼부(21, 22)가 형성되어 원심 분리시 혈구 성분들이 잘 이동될 수 있도록 구성되어 있다.The plasma extraction kit 1 is divided into an upper space 10, a funnel 20, and a blood storage unit 30 from above. After centrifugation, the upper space 10 is a section where plasma is collected, the blood storage unit 30 is a space where red blood cells are collected, and the funnel 20 is designed to form a boundary of two layers. The upper end 21 and the lower end of the funnel are formed with funnel-shaped tapered parts 21 and 22 that are gradually smaller or larger in diameter so that the blood cell components can be moved well during centrifugation.
또한, 상기 혈장추출키트는 평균 적혈구량을 기준으로 전체의 상위 및 하위 80-90%의 분포도를 보이는 범위의 적혈구가 하부공간 및 상기 깔대기부의 좁고 길다란 모세관(23)에 수용될 수 있도록 용량이 설계되어 있다. 따라서 1차 원심분리를 하고 나면 적혈구 최상층의 위치가 모세관내의 어느 한 부분에 위치하게 된다. 그 바로 위쪽으로 PRP가 원심분리관의 단면적이 적어진 만큼 밀집되어 두껍게 쌓여 있게 된다. 이 경우 상기 깔대기부의 높이 조절이 필요없이 바로 니들을 삽입하여 PRP를 포함한 그 위쪽의 PPP를 모두 한꺼번에 추출한다. In addition, the plasma extraction kit has a capacity designed so that the red blood cells in the range showing the distribution of the upper and lower 80-90% of the total based on the average red blood cells can be accommodated in the lower space and the narrow and long capillary 23 of the funnel. It is. Therefore, after the first centrifugation, the position of the uppermost layer of red blood cells is located in any part of the capillary. Immediately above, the PRP is densely packed and thickened as the cross-sectional area of the centrifuge tube is reduced. In this case, the needle is inserted directly without the need for height adjustment of the funnel to extract all of the upper PPP including the PRP at once.
이 때 적혈구 상층면과 PRP 하층면의 경계부위에서는 적혈구와 혈소판 두 종류의 혈구가 서로 얽혀있는데 이 부분을 추출하는 단계에서 가능한 한 적혈구를 포함하지 않고 추출하기 위해 작업시간이 많이 걸리게 되며, 조작자의 숙련도에 따라서 추출액의 품질에 편차가 생기게 된다. 적혈구를 흡입하지 않기 위해서는 경계면에서 적혈구와 엉켜있는 상당량의 혈소판 추출을 포기해야 하고, 혈소판의 추출율을 높이고 싶으면 어쩔수 없이 적혈구를 같이 흡입할 수 밖에 없다는 문제가 있다. 그러나 본 장치에서는 2차례의 공정을 통해 흡입된 적혈구를 배제할 수 있으므로 상층의 적혈구층을 포함하여 경계부위의 PRP와 함께 모든 PRP 및 PPP를 신속하게 흡입하면 되고 이로서 1차 원심분리관에서의 공정은 끝이 난다.At this time, at the boundary between the upper surface of the red blood cells and the lower surface of the PRP, two types of blood cells are entangled with each other. In the step of extracting this part, it takes a long time to extract the red blood cells as much as possible. Depending on the skill, the quality of the extract will vary. In order not to inhale erythrocytes, a significant amount of platelet extraction, which is entangled with erythrocytes at the interface, must be given up, and if you want to increase the extraction rate of platelets, you have no choice but to inhale erythrocytes together. However, in this device, the inhaled red blood cells can be excluded through the second process, so all the PRP and PPP can be sucked quickly together with the PRP at the boundary including the upper red blood cell layer. Ends.
도 7 및 도 8에 나타낸 바와 같이, 1차 원심분리 후 사람에 따라 과도하게 많은 적혈구나 과소한 적혈구로 인해 기다란 모세관이 수용하지 못하는 범위에 있게 되면 상기 덮개(41)를 돌려 상기 내부관의 높이를 조절하여 PRP층을 모세관내의 어느 한 부분에 위치하게 하고 상술한 방법대로 PRP 및 PPP를 추출한다. As shown in Fig. 7 and 8, after the first centrifugation, if the elongated capillaries are not accommodated due to excessive red blood cells or excessive red blood cells, the cover 41 is turned to turn the height of the inner tube. By adjusting the PRP layer is located in any part of the capillary and PRP and PPP are extracted in the manner described above.
이때에도 모세관의 길이가 매우 길어 위치조정을 조금만 하여도 PRP의 위치가 모세관의 수용 범위 내에 들어오므로 모세관의 길이가 좁은 제품과 다르게 훨씬 용이한 추출이 가능하다.At this time, the length of the capillary tube is very long, so even if the position adjustment is a little, the position of the PRP falls within the acceptance range of the capillary tube, which is much easier to extract than the narrow capillary product.
이렇게 추출한 PPP, PRP 및 소량의 흡입된 적혈구를 2차 원심분리관(2)으로 옮겨 2차 원심분리를 한다.The extracted PPP, PRP and a small amount of sucked red blood cells are transferred to the secondary centrifuge tube (2) and subjected to secondary centrifugation.
도 9에 나타낸 바와 같이, 2차 원심분리관(2)은 대략 원통형 형상으로 형성되어 있고, 그 하단부에는 상부보다 직경이 작은 좁은 제 2 모세관(71)이 형성되어 있으며, 상기 제 2 모세관(71)의 끝단부분에는 원뿔형으로 되어 직경이 더 작아지다가 끝은 꼭지점으로 끝나는 첨단부(72)가 형성되어 있다.As shown in FIG. 9, the secondary centrifuge tube 2 is formed in a substantially cylindrical shape, and at the lower end thereof, a narrow second capillary tube 71 having a smaller diameter than the upper portion is formed, and the second capillary tube 71 is formed. At the end of the tip) is a conical shape is made smaller in diameter and ends are formed with a tip portion 72 ends with a vertex.
이 특수하게 고안된 2차 원심분리관으로 원심분리를 하게 되면 상부부터 PPP, PRP 그리고 같이 흡입된 소량의 적혈구층이 형성된다.Centrifugation with this specially designed secondary centrifuge tube forms PPP, PRP, and a small amount of red blood cells inhaled from the top.
상부의 PPP(81)는 필요하지 않으므로 소량만 남기고 추출한 뒤 폐기한다.Since the upper PPP 81 is not necessary, only a small amount is extracted and discarded.
이제 남은 것은 위쪽부터 소량의 PPP(82), PRP(83), 소량의 적혈구(84)이다.All that remains is a small amount of PPP 82, PRP 83, and a small amount of red blood cells 84 from above.
가장 하부의 적혈구는 소량이므로 2차 원심분리관의 상기 첨단부(72) 안에 모두 수용되어진다.The lowest red blood cells are all contained within the tip portion 72 of the secondary centrifuge tube.
이제 니들을 PRP 층에 닿게 하여 하부의 적혈구를 제외한 나머지 액을 추출하게 되는데 하부의 적혈구는 매우 좁은 공간에만 모여 있으므로 이들을 거의 건드리지 않고 소량의 PPP 및 PRP만을 극도로 선별하여 추출할 수 있게 되어 고순도, 고농축율의 PRP를 얻을 수 있게 된다.Now, the needle touches the PRP layer and extracts the remaining liquid except the lower red blood cells, and since the lower red blood cells are collected only in a very narrow space, it is possible to extract only a small amount of PPP and PRP with very little touch without extracting them. High concentration PRP can be obtained.
또 다른 방법으로는 제일 먼저 맨 아래층의 첨단부 공간의 적혈구층까지 니들을 넣어 적혈구를 추출하고 폐기한 뒤, 두 번째로 상층의 PPP를 추출하고 폐기하면 소량의 PPP, PRP만 남게 된다. 이로써 시간을 들여 세심하게 추출할 필요없이 실린더에 남아있는 모든 용액을 한꺼번에 쭉 추출하면 고순도, 고농축율의 PRP 치료액이 만들어진다. Another method is to first extract the red blood cells and discard them by inserting the needles into the red blood cell layer of the uppermost space of the bottom layer, and then extracting and discarding the upper layer of PPP, leaving only a small amount of PPP and PRP. This ensures high purity and high concentration of PRP treatment solution by extracting all the remaining solution in the cylinder all at once without the need for timely extraction.
어느 방법으로 하던지 적혈구를 배제하고 PRP를 추출하기가 매우 용이하며 이렇게 추출된 PRP는 적혈구가 거의 없는 고농도의 순수한 PRP가 된다.Either way, it is very easy to exclude red blood cells and extract PRP. The extracted PRP becomes high concentration pure PRP with few red blood cells.
본 장치를 이용할 때 또 하나의 장점은 PRP의 농축율을 조절할 수 있다는 점이다. 상층의 PPP를 추출할 때 남기는 PPP양에 따라 PRP의 농축율이 변하게 된다. 정상인의 혈소판 숫자가 1마이크로 리터당 10만개에서 20만개 정도인데 PRP시술로서 치료효과를 얻으려면 통상 그 5배인 100만개 이상으로 농축되어야 한다.Another advantage of using this device is the ability to control the concentration of PRP. When extracting the upper PPP, the concentration of PRP changes according to the amount of PPP remaining. The number of platelets in a normal person is about 100,000 to 200,000 per microliter, but the concentration should be concentrated to more than 1 million, which is five times that of PRP.
PPP를 남기지 않고 거의 제거한 뒤 순수 PRP만 추출해 보면 혈소판 숫자가 160만개에서 180만개 까지도 이를 수 있으나 이 경우 PRP로만 이루어진 최종 치료액은 그 용량이 너무 적어 치료 부위가 매우 좁은 부위에 한정된다는 단점이 있다.If only PRP is extracted after almost removing without leaving PPP, the number of platelets can reach 1.6 million to 1.8 million. However, in this case, the final treatment solution composed of PRP is too small, so the treatment area is limited to a very narrow area. .
이러한 이유로 인해 적정 용량의 PRP 주입액을 확보하기 위하여 소량의 PPP를 포함하여 PRP를 추출하게 되는데 농축율을 다르게 추출하고 싶으면 2차 원심분리 후 상층부의 PPP를 추출할 때, 남기는 PPP의 양을 조절하면 된다. PPP를 많이 남기면 최종 치료주입액의 용량은 늘어나지만 저농축율의 PRP가 되고, PPP를 적게 남기면 치료주입액의 용량은 적지만 고농축율의 PRP를 얻을 수 있게 되는 것이다. For this reason, PRP is extracted including a small amount of PPP in order to secure an appropriate volume of PRP injection. If you want to extract different concentration rates, adjust the amount of PPP remaining when extracting PPP in the upper layer after the second centrifugation. Just do it. If you leave a lot of PPP, the dose of the final treatment injection will increase, but it will be a low concentration of PRP. If you leave less PPP, you will get a high concentration of PRP, although the dose of treatment injection is small.
최종 치료주입액 용량을 어느 정도로 할 것인가 하는 문제는 시술하는 의사가 치료 부위의 면적에 따라 결정하게 되는데 본 장치를 사용하게 되면 이와 같이 그 농축율 조절을 매우 간단할 수 있다는 장점이 있다.The question of how much the final treatment dose is to be determined is determined by the treating physician according to the area of the treatment site. The use of this device has the advantage that the concentration control can be very simple.
본체부 및 2차 원심분리관 모두 하부가 연결부위가 없는 밀폐형으로 제작되므로 고속회전에 의해 혈액 누출의 염려가 없는 견고한 구조로 되어있는 것도 특징이다.Both the main body and the secondary centrifuge tube are made of a closed type with no connecting part, so it is also characterized by a robust structure without fear of blood leakage by high-speed rotation.
본 실시예에 의한 혈장추출키트를 이용하여 PRP를 추출하게 되면 다음과 같은 이점이 있다.Extracting PRP using the plasma extraction kit according to the present embodiment has the following advantages.
첫째 모세관이 상하에 테이퍼부를 형성하고 중앙부분이 기다랗게 형성되어 있어 적혈구양의 변화에 따른 편차를 대부분 수용할 수 있어 별도의 조작이 필요없기 때문에 PRP를 추출하는 시간이 단축이 된다.First, the capillary is tapered up and down, and the central part is elongated to accommodate most of the variation due to the change in red blood cell volume, so that no time is required to extract PRP.
둘째 적혈구량의 변화가 편차를 벗어나게 되어 PRP가 기다랗게 형성된 모세관의 수용범위를 초과하게 되면 실린더 덮개를 돌려 높이 조정을 하여 추출할 수 있도록 2차 보정장치가 있다. 이때에도 모세관이 길므로 시술자의 조작 오차 범위가 넓어 추출이 용이하고 빠르다는 장점이 있다.Second, when the change in the red blood cell volume is out of the deviation and the PRP exceeds the receiving range of the long capillary tube, there is a secondary correction device that can be extracted by adjusting the height by turning the cylinder cover. At this time, since the capillary is long, there is an advantage that the operator's operating range is wide and easy to extract.
셋째 1차 원심분리 후 PRP, PPP를 추출할 때 같이 포함되어 추출할 수 밖에 없는 소량의 적혈구는 2차 원심분리관을 통해 배제할 수 있으므로 적혈구가 포함되지 않는 순도높은 PRP를 추출할 수 있다.Third, a small amount of erythrocytes included in the extraction of PRP and PPP after the first centrifugation can be excluded through the second centrifuge tube, so that PRP can be extracted without high erythrocytes.
넷째 고안된 2차 원심분리관을 사용하게 되면 상술한 대로 PRP의 농축율 조절이 가능하다.The fourth designed second centrifuge tube can be used to control the concentration of PRP as described above.
다섯째 본체부, 2차 원심분리관 모두 뚜껑을 열지 않고 조작이 가능하도록 설계되어 있어 외부 감염에 대해 안전하다.Fifth, the main body and the second centrifuge tube are designed to be operated without opening the lid, which is safe against external infection.
여섯째 원심분리 때 가장 많은 탈출 압력이 걸리는 원심분리관의 하부가 연결부위가 없는 밀폐형으로 되어있어 혈액 누출의 위험이 없다Sixth centrifugation, the lower part of the centrifuge tube, which has the highest escape pressure during the centrifugation, is a sealed type with no connection, so there is no risk of blood leakage
일곱째 하부에 높이 조절용 나사가 달려있는 기존의 혈액 분리 장치에 비해 구조가 단순하여 적은 비용으로 제작이 가능하다.The seventh lower part is simpler in structure compared to the existing blood separation device with a height adjusting screw, and thus can be manufactured at a low cost.
<실시예 2><Example 2>
도 14 내지 도 22는 본 발명의 제 2 실시예에 의한 혈장추출키트(100)를 나타내는 도면이다. 14 to 22 are diagrams showing the plasma extraction kit 100 according to the second embodiment of the present invention.
도 14 내지 도 22에 나타낸 바와 같이, 본 실시예에 의한 혈장추출키트는 본체부(110)와, 덮개부(120)와, 혈액저장부(130)와, 깔대기부(140, 141)와, 연결날개부(150)와, 개폐 캡(160)을 포함한다. As shown in Figures 14 to 22, the plasma extraction kit according to the present embodiment is the main body 110, the cover 120, the blood storage 130, the funnel 140, 141, Connection wing unit 150, and includes an opening and closing cap 160.
상기 본체부(110)는 상단이 개구되고 하단이 폐쇄되어 있는 원통형 형상으로 형성되어 있다. 상기 본체부(110)의 재질은 특히 한정되지는 않으나, 본 실시예에 있어서는 제조비용이 저렴하고 제조가 용이한 플라스틱 재질인 것을 예로 한다. The main body 110 is formed in a cylindrical shape with an upper end opened and a lower end closed. The material of the main body 110 is not particularly limited, but in the present embodiment, the material is made of a plastic material having low manufacturing cost and easy manufacturing.
상기 본체부(10)의 내부면의 중앙부분에는 체결홈(110b)이 형성된다. 상기 체결홈(110b)은 상기 본체부의 내측면에서 오목하게 절개되어 형성되며, 상기 본체부 내측면의 전체 둘레에 걸쳐 형성되지 않고 일정한 폭을 구비하도록 형성된다. A fastening groove 110b is formed at the center of the inner surface of the main body 10. The fastening groove 110b is formed to be concavely cut away from the inner side of the main body, and is formed to have a constant width without being formed over the entire circumference of the inner side of the main body.
상기 체결홈(110b)을 형성함으로써 상기 체결홈(110b)의 하부에 형성되는 단턱(110a)에 후술하는 깔대기부가 얹어놓여지며, 후술하는 연결날개부의 이동에 의한 상기 깔대기부의 회전이 상기 체결홈의 폭만큼 한정되도록 구성된다. By forming the fastening groove 110b, the funnel portion to be described later is placed on the stepped portion 110a formed at the bottom of the fastening groove 110b, and the rotation of the funnel portion by the movement of the connection blade to be described later is performed by the fastening groove. It is configured to be limited by the width.
상기 본체부의 상부에는 상기 본체부와 후술하는 덮개부와의 사이에 패킹이나 O링 등의 밀봉부재(110c)가 개재되어 상기 본체부를 밀폐하도록 구성된다. An upper portion of the main body portion is provided to seal the main body portion with a sealing member 110c such as a packing or an O-ring interposed between the main body portion and a cover portion described later.
상기 본체부의 내부 하단에는 혈액저장부(130)가 수용된다. 상기 혈액저장부는 상단이 개구되고 하단이 폐쇄된 원통형상으로 형성되며 상기 본체부 내부에 기밀하게 수용된다. 상기 혈액저장부(130)에는 주입된 혈액의 원심분리 후에 혈액의 적혈구 부분이 수용된다. The blood storage unit 130 is accommodated in the inner lower end of the main body. The blood reservoir is formed in a cylindrical shape with an upper end opened and a lower end closed, and is hermetically received inside the main body. The blood storage unit 130 receives the red blood cell portion of the blood after centrifugation of the injected blood.
상기 본체부의 내부에서 상기 혈액저장부의 상부에는 깔대기부(140, 141)가 설치된다. 상기 깔대기부(140, 141)는 상기 본체부의 내부 중앙부분에 체결되며, 도 15 및 도 16에 나타낸 바와 같이, 중앙부의 직경이 작고 양단부는 중앙부를 향하여 직경이 점차 감소하는 테이퍼 형상으로 형성된다. Funnels 140 and 141 are installed above the blood storage unit in the main body. The funnels 140 and 141 are fastened to the inner central portion of the main body, and as shown in FIGS. 15 and 16, the diameter of the central portion is small and both ends are formed in a tapered shape in which the diameter gradually decreases toward the central portion.
이로써, 적혈구 상층면과 PRP 하층면의 경계부위에서는 적혈구와 혈소판 두 종류의 혈구가 서로 얽혀있는데 이 부분을 추출하는 단계에서 가능한 한 적혈구를 포함하지 않고 추출하기 위해 작업시간이 많이 걸리게 되며, 조작자의 숙련도에 따라서 추출액의 품질에 편차가 생기게 되지만, 본 발명에 의하면 원심분리후에 혈액성분 중 다량인 적혈구는 상기 혈액저장부에 수용되고, 소량인 PRP는 직경이 작은 깔대기부의 중앙에 수용할 수 있으며, PRP가 소량이라 하더라도 직경이 작은 깔대기부의 중앙부분에 수용되므로 순도 높은 고농도의 PRP를 용이하게 추출할 수 있고, 추출 과정에서 적혈구를 거의 배제하고 추출할 수 있다. As a result, red blood cells and platelets are intertwined in the boundary area between the upper surface of the red blood cells and the lower surface of the PRP. In the step of extracting these parts, it takes a long time to extract the red blood cells as much as possible. According to the present invention, the quality of the extract may vary, but according to the present invention, after centrifugation, a large amount of red blood cells in the blood component is accommodated in the blood storage unit, and a small amount of PRP can be accommodated in the center of the funnel having a small diameter. Even if a small amount of PRP is accommodated in the central portion of the funnel having a small diameter, it is possible to easily extract high-purity high concentrations of PRP, and almost eliminate red blood cells in the extraction process.
본 실시예에 있어서, 상기 깔대기부는 하나의 단위체로 형성될 수도 있으나, 플라스틱 재질로 사출성형할 때에 직경이 작은 중앙부의 경우 기포의 발생 등 불량이 발생하여 불량이 발생할 염려가 있으므로, 내통(141)과 외통(140)으로 분리되어 형성되는 것을 예로 한다. In the present embodiment, the funnel portion may be formed as one unit, but in the case of injection molding of plastic material, the inner portion of the central portion having a small diameter may cause a defect such as the generation of bubbles due to the occurrence of a defect. For example, it is formed separately from the outer cylinder 140.
상기 내통(141)은 중앙부분의 직경이 작고 양단부는 중앙부를 향하여 직경이 점차 감소하는 테이퍼 형상으로 형성된다. The inner cylinder 141 is formed in a tapered shape in which the diameter of the central portion is small and both ends gradually decrease in diameter toward the central portion.
상기 외통(140)은 상하부가 개구된 중공의 원통형 형상으로 형성되어 있으며, 상기 외통의 하단부는 내측으로 연장되어 돌출되도록 형성되며, 돌출된 부분의 상단에는 안착홈(140b)이 마련된다. 상기 안착홈(140b)에는 상기 내통의 테이퍼 형상의 하단 끝단부가 삽입되어 안착되어 상기 내통과 상기 외통이 일체로 연결되도록 구성된다. The outer cylinder 140 is formed in a hollow cylindrical shape of the upper and lower openings, the lower end of the outer cylinder is formed to extend inward to protrude, the seating groove 140b is provided on the upper end of the protruding portion. The lower end of the tapered shape of the inner cylinder is inserted and seated in the seating groove 140b so that the inner cylinder and the outer cylinder are integrally connected to each other.
상기 외통(140)에는 상기 외통의 외부면으로부터 상기 외통의 길이방향을 따라 외측으로 돌출되어 체결돌기(140a)가 형성되어 있다. 상기 체결돌기(140a)는 상기 본체부의 체결홈(110b)에 삽입된다. The outer cylinder 140 has a fastening protrusion 140a protruding outward from the outer surface of the outer cylinder along the longitudinal direction of the outer cylinder. The fastening protrusion 140a is inserted into the fastening groove 110b of the main body.
또한, 상기 외통(140)의 상단부에는 걸림고정홈(140c)이 형성된다. 상기 걸림고정홈(140c)은 상기 외통의 상부끝단으로부터 역T자 형상으로 절개되어 형성된다. 상기 걸림고정홈(140c)에는 후술하는 연결날개부의 제 1 날개부가 삽입되어 상기 연결날개부와 상기 외통이 일체로 거동하도록 구성된다. In addition, the upper end of the outer cylinder 140, the locking groove 140c is formed. The locking fixing groove 140c is formed by cutting in an inverted T shape from the upper end of the outer cylinder. The locking blade groove (140c) is inserted so that the first wing portion of the connecting blade portion to be described later is configured so that the connecting blade portion and the outer cylinder behave integrally.
상술한 구성에 의하여, 상기 외통의 상단부분에 연결날개부가 연결되어 상기 연결날개부가 후술하는 바와 같이, 덮개부에 나사체결되어 덮개부를 회전시키면 상기 연결날개부 및 이에 연결된 외통은 회전하게 된다. 이 때, 상기 외통의 상기 체결돌기는 상기 본체부의 체결홈에 삽입된 상태에서 상기 체결홈의 폭만큼 회전되다가 상기 체결홈의 끝단에 의해 저지되고, 이에 따라 회전이 저지된 상기 외통은 상기 연결날개부에 고정된 상태에서 상기 덮개부의 회전에 의해 상기 본체부의 내부에서 상부 또는 하부로 위치가 이동할 수 있도록 구성된다. By the above-described configuration, when the connection blade is connected to the upper end of the outer cylinder, and the connection blade is screwed to the cover portion as described below, when the cover portion rotates, the connection blade portion and the outer cylinder connected thereto are rotated. At this time, the fastening protrusion of the outer cylinder is rotated by the width of the fastening groove in the state inserted into the fastening groove of the main body portion is blocked by the end of the fastening groove, thereby the outer cylinder is stopped rotation is the connection blade It is configured to move the position from the inside of the main body portion to the upper or lower by the rotation of the cover portion in a fixed state.
이로써, 사람에 따라 적혈구의 양이 다르다 하더라도 상기 연결날개부 및 상기 깔대기부의 구성에 의해 상기 깔대기부의 위치를 조정할 수 있으므로, 상기 깔대기부에 PRP를 정확하게 위치시킬 수 있고, 이로써 소량인 PRP는 직경이 작은 깔대기부의 중앙에 수용할 수 있으며, PRP가 소량이라 하더라도 직경이 작은 깔대기부의 중앙부분에 수용되므로 순도 높은 고농도의 PRP를 용이하게 추출할 수 있고, 추출 과정에서 적혈구를 거의 배제하고 추출할 수 있다. Thus, even if the amount of red blood cells differs from person to person, since the position of the funnel can be adjusted by the configuration of the connecting wing part and the funnel part, the PRP can be accurately positioned in the funnel part, whereby a small amount of PRP has a diameter. It can be accommodated in the center of a small funnel, and even if a small amount of PRP is accommodated in the center of a small funnel, it can easily extract high-purity PRP with high purity and almost eliminate red blood cells in the extraction process. .
상기 연결날개부(150)는 일측은 상기 덮개부에 체결되고, 타측은 상기 외통에 체결된다. The connection wing 150 is one side is fastened to the cover portion, the other side is fastened to the outer cylinder.
상기 연결날개부(150)는, 상기 외통과 체결되는 부분에 제 1 날개부(152)가 형성되고, 상기 덮개부에 체결되는 측에 연결돌기(151)가 형성된다. The connecting wing unit 150, the first wing portion 152 is formed in a portion that is fastened with the outer cylinder, the connection protrusion 151 is formed on the side that is fastened to the cover portion.
상기 제 1 날개부(152)는 상기 연결날개부의 폭으로부터 외측으로 돌출되어 T자 형상으로 형성되며, 상기 걸림고정홈(140c)에 삽입된다. 상기 연결돌기(151)는 상기 연결날개부의 본체로부터 내측, 즉 상기 본체부의 중앙측을 향하여 일정길이 돌출되도록 형성되며, 상기 덮개부에 형성된 나사산에 체결되도록 구성된다. The first wing portion 152 protrudes outward from the width of the connecting wing portion to have a T-shape, and is inserted into the locking fixing groove 140c. The connecting protrusion 151 is formed to protrude a predetermined length toward the inner side, that is, the central side of the main body portion from the main body of the connecting wing portion, is configured to be fastened to the screw thread formed in the cover portion.
상기 본체부의 상부에는 덮개부(120)가 마련되고, 상기 덮개부(120)는 상기 본체부의 상단을 폐쇄하도록 구성된다.  The cover part 120 is provided at an upper portion of the main body part, and the cover part 120 is configured to close the upper end of the main body part.
상기 덮개부(120)는 상기 본체부의 상단을 덮는 상부면과 상기 상부면으로부터 수직 하향으로 연장되어 형성되어 상기 본체부의 내부에 삽입되는 연장부를 구비하며, 상기 연장부의 외주면에는 나사산(121)이 형성되어 있고 상기 나사산에는 상기 연결날개부의 연결돌기가 나사결합되도록 구성되어 있다. The cover part 120 includes an upper surface covering an upper end of the main body and an extension part extending downward from the upper surface and inserted into the main body, and a thread 121 is formed on an outer circumferential surface of the extension. The screw thread is configured such that the connecting projection of the connecting blade portion is screwed.
상기 덮개부의 상기 상부면과 상기 연장부 사이에는 지지돌기(122)가 형성되어 상기 상부면의 하부와 상기 지지돌기 사이에 상기 밀봉부재(110c)를 설치하여 상기 덮개부와 상기 본체부 사이를 안정적으로 밀봉할 수 있도록 구성된다.A support protrusion 122 is formed between the upper surface of the cover portion and the extension portion, so that the sealing member 110c is installed between the lower portion of the upper surface and the support protrusion to stabilize the cover portion and the main body portion. It is configured to be sealed by.
상기 덮개부의 상부면 중앙에는 체결홀(123)이 형성되며, 상기 체결홀(123)에는 후술하는 개폐 캡(160)이 개폐가능하게 삽입된다. 또한, 상기 덮개부에는 상기 체결홀의 중앙을 향하여 돌출되는 돌출부(124)가 형성된다. 상기 돌출부에는 후술하는 개폐 캡의 걸림돌기가 걸림고정되어, 상기 개폐 캡의 개폐시에 상기 개폐 캡이 상기 덮개부로부터 이탈되지 않고 안정적으로 개폐되도록 구성된다. A fastening hole 123 is formed in the center of the upper surface of the cover part, and the opening and closing cap 160, which will be described later, is inserted into the fastening hole 123 to be opened and closed. In addition, the cover portion is formed with a protrusion 124 protruding toward the center of the fastening hole. The protrusion of the opening / closing cap to be described later is locked to the protrusion, and the opening / closing cap is configured to be opened and closed stably without being separated from the cover part when the opening / closing cap is opened or closed.
상기 덮개부의 체결홀(123)에는 개폐 캡(160)이 삽입된다. 상기 개폐 캡(160)은 상기 덮개부에 개폐가능하게 체결된다. The opening and closing cap 160 is inserted into the fastening hole 123 of the cover part. The opening and closing cap 160 is fastened to the cover portion to be openable.
상기 개폐 캡(160)은 주입홀(161)과, 걸림돌기(162a, 162b)와, 밀폐막(163)을 구비한다. 상기 주입홀(161)은 환자로부터 추출한 혈액을 주입하는 주사기의 주사바늘이 삽입될 수 있도록 상기 개폐 캡의 본체의 일측면에 형성된다. The opening / closing cap 160 includes an injection hole 161, locking protrusions 162a and 162b, and a sealing membrane 163. The injection hole 161 is formed on one side of the main body of the opening and closing cap so that the needle of the syringe for injecting blood extracted from the patient can be inserted.
상기 걸림돌기는 상부 걸림돌기(162b)와, 하부 걸림돌기(162a)로 구성되며, 상기 개폐 캡의 본체로부터 외측으로 돌출되어 형성된다. 상기 개폐 캡을 개방할 때에는 상기 하부 걸림돌기(162a)가 상기 덮개부의 상기 돌출부의 하부면에 맞닿아 걸림고정되며, 상기 개폐 캡을 밀폐할 때에는 상기 상부 걸림돌기(162b)가 상기 돌출부의 상부면에 맞닿아 상기 덮개부와 상기 개폐 캡 사이를 밀봉하도록 구성된다. The locking protrusion is composed of an upper locking protrusion 162b and a lower locking protrusion 162a and protrudes outward from the main body of the opening / closing cap. When the opening and closing cap is opened, the lower locking protrusion 162a comes into contact with the lower surface of the protruding portion of the cover part, and when the closing cap is closed, the upper locking protrusion 162b is upper surface of the protruding portion. Abuts against and seals between the lid and the opening / closing cap.
상기 밀폐막(163)은 상부면 중앙에 형성된 개구를 폐쇄하며, 원심분리된 혈액의 다혈소판 혈장을 추출하기 위한 주사기가 용이하게 삽입될 수 있는 재질로 형성되는 것이 바람직하다. The sealing membrane 163 closes the opening formed at the center of the upper surface, and is preferably formed of a material into which a syringe for extracting the multiplatelet plasma of the centrifuged blood can be easily inserted.
상술한 구성을 가지는 본 발명의 혈장추출키트를 사용예에 대하여, 도 9를 참조하여 설명한다. An example of using the plasma extraction kit of the present invention having the above-described configuration will be described with reference to FIG.
우선, 공장에서 제조된 본 발명에 의한 혈장추출키트를 상기 덮개부로부터 상기 개폐 캡을 개방한 상태로 포장지에 밀봉한다. 여기서, 상기 포장지는 일면이 소독가스가 침투할 수 있는 특수 종이재질로 구성되는 것이 바람직하다. First, the plasma extraction kit according to the present invention manufactured in a factory is sealed in a wrapping paper with the opening and closing cap open from the cover part. Here, the wrapping paper is preferably made of a special paper material that one side can penetrate the disinfection gas.
상기 포장지에 밀봉된 상태에서 상기 혈장추출키트를 EO가스 등의 소독가스를 사용하여 소독하면, 포장지를 침투한 소독가스는 상기 개폐 캡의 주입홀을 통해 혈장추출키트의 내부로 주입되어 소독이 용이하게 이루어진다. When the plasma extraction kit is sterilized using a disinfection gas such as EO gas in the sealed state, the disinfection gas penetrating the packaging is injected into the plasma extraction kit through the injection hole of the opening and closing cap to facilitate disinfection. It is done.
그런 다음, 사용시에 포장지를 벗겨낸 후, 환자로부터 추출한 혈액이 담겨 있는 주사기의 주사바늘을 상기 개폐 캡의 주입홀을 통해 주입한다. Then, after use, the wrapping paper is peeled off, and the needle of the syringe containing the blood extracted from the patient is injected through the injection hole of the opening / closing cap.
혈액 주입이 완료되면, 상기 개폐 캡을 눌러 상기 덮개부와 상기 개폐 캡을 밀봉함으로써 혈장 추출을 위한 준비가 완료된다. When blood injection is completed, pressing the opening and closing cap seals the lid and the opening and closing cap to complete preparation for plasma extraction.
그런 다음, 상기 혈장추출키트를 원심분리기에 의해 원심분리한 후, 혈장채취용 주사기를 상기 개폐 캡의 밀폐막을 통해 주입한 후, 주사바늘의 끝단을 상기 깔대기부의 직경이 작은 중앙부까지 삽입하여 PRP를 간단하게 추출할 수 있다. Then, the plasma extraction kit is centrifuged by a centrifuge, and a plasma collection syringe is injected through the sealing membrane of the opening / closing cap. Then, the end of the needle is inserted into the center of the small diameter of the funnel to insert the PRP. It can be extracted simply.
이로써, 상기 덮개부에 개폐가 가능한 개폐 캡을 설치하고 개폐 캡에 주입홀을 구비함으로써, 상기 본체부에 상기 덮개부를 체결한 상태로 상기 혈장추출키트를 포장지로 밀봉하더라도 상기 혈장추출키트를 EO가스에 의해 소독할 때에 소독가스가 상기 개폐 캡의 주입홀을 통해 상기 혈장추출키트의 내부로 투입될 수 있으므로 소독을 용이하게 할 수 있다. Thus, by installing an opening and closing cap that can be opened and closed on the cover portion and the injection hole in the opening and closing cap, even if the plasma extraction kit is sealed with a wrapping paper in the state that the cover portion is fastened to the EO gas When disinfecting by the disinfection gas can be introduced into the plasma extraction kit through the injection hole of the opening and closing cap can facilitate disinfection.
또한, 사용시에 상기 개폐 캡을 개방한 후 상기 개폐 캡의 주입홀에 주사기의 바늘을 삽입하여 혈액을 주입한 후 상기 개폐 캡을 눌러 밀봉할 수 있으므로, 마개 전체를 제거한 후 혈액을 투입하고 마개를 다시 밀봉시켜야 하는 종래의 방식에 비하여 사용시 오염의 염려가 적고 사용이 매우 간편하다고 하는 이점이 있다. In addition, since the opening and closing the cap to open and then insert the needle of the syringe into the injection hole of the opening and closing cap to inject the blood and then press the opening and closing cap to seal, so after removing the entire stopper, the blood is inserted and the stopper Compared with the conventional way of resealing, there is an advantage that there is less concern about contamination and very easy to use.

Claims (13)

  1. 상단이 개구되고 하단이 폐쇄되어 있는 원통형 형상의 본체부와, A cylindrical body having an upper end opened and a lower end closed;
    상기 본체부의 내부 중앙부분에 체결되며, 중앙부의 직경이 작고 양단부는 중앙부를 향하여 직경이 점차 감소하는 테이퍼 형상으로 형성된 깔대기부와, A funnel portion fastened to an inner central portion of the main body portion, the diameter of the central portion being small and both ends formed in a tapered shape gradually decreasing in diameter toward the central portion;
    상기 본체부의 상단을 폐쇄하는 덮개부를 구비하는 것을 특징으로 하는 혈장추출키트.Plasma extraction kit comprising a cover portion for closing the upper end of the main body portion.
  2. 제 1 항에 있어서, The method of claim 1,
    상기 본체부의 내측면에는 상기 깔대기부를 일정 위치에 유지하도록 이탈을 방지하는 걸림턱이 형성되어 있는 것을 특징으로 하는 혈장추출키트.Plasma extraction kit, characterized in that the inner side of the main body portion is formed with a locking jaw to prevent separation to maintain the funnel in a predetermined position.
  3. 제 1 항에 있어서, The method of claim 1,
    상기 덮개부에 개폐가능하게 체결되며, 환자로부터 추출한 혈액을 주입하는 주사기의 주사바늘이 삽입될 수 있는 주입홀을 일측면에 구비한 개폐 캡을 구비하는 것을 특징으로 하는 혈장추출키트.Plasma extraction kit is fastened to the opening and closing portion, characterized in that it has an opening and closing cap having an injection hole in one side that can be inserted into the needle of the syringe for injecting blood extracted from the patient.
  4. 제 3 항에 있어서, The method of claim 3, wherein
    상기 개폐 캡은, 상부면 중앙에 형성된 개구를 폐쇄하며, 원심분리된 혈액의 다혈소판 혈장을 추출하기 위한 주사기가 용이하게 삽입될 수 있는 재질로 형성된 밀폐막을 더욱 구비하는 것을 특징으로 하는 혈장추출키트.The opening and closing cap, the opening is formed in the center of the upper surface, the plasma extraction kit further comprises a sealing membrane formed of a material that can be easily inserted into the syringe for extracting the multi-platelet plasma of the centrifuged blood .
  5. 제 3 항에 있어서, The method of claim 3, wherein
    상기 덮개부는 중앙에 체결홀이 형성되고, 상기 체결홀로부터 돌출되는 돌출부를 구비하며, The cover part has a fastening hole formed in the center, and has a protrusion projecting from the fastening hole,
    상기 개폐 캡은, 하부끝단으로부터 외측으로 돌출되어 상기 덮개부의 돌출부에 걸림고정되는 걸림돌기를 구비하는 것을 특징으로 하는 혈장추출키트.The opening and closing cap is a plasma extraction kit characterized in that it comprises a locking projection protruding outward from the lower end is locked to the protrusion of the cover portion.
  6. 제 1 항에 있어서, The method of claim 1,
    상기 깔대기부의 하부에 마련되며 상기 본체부의 내부 하단에 설치되어 주입되는 혈액을 수용하는 혈액저장부를 더욱 구비하는 것을 특징으로 하는 혈장추출키트.Plasma extraction kit is provided in the lower portion of the funnel and further provided with a blood storage unit for receiving the blood is installed is installed in the inner bottom of the main body portion.
  7. 제 1 항에 있어서, The method of claim 1,
    상기 깔대기부는, The funnel,
    중앙부분의 직경이 작고 양단부분은 중앙부분을 향하여 직경이 점차 감소하는 테이퍼 형상으로 형성된 내통과, Inner passage formed in a tapered shape in which the diameter of the central portion is small and both ends gradually decrease in diameter toward the central portion,
    상하부가 개구되고 상기 내통의 양단부가 체결되는 중공의 원통형상으로 형성된 외통으로 형성되는 것을 특징으로 하는 혈장추출키트.Plasma extraction kit characterized in that the upper and lower portions are formed in an outer cylinder formed in a hollow cylindrical shape to which both ends of the inner cylinder is fastened.
  8. 제 7 항에 있어서, The method of claim 7, wherein
    상기 외통은 외측으로 돌출된 체결돌기가 형성되어 있고, The outer cylinder has a fastening protrusion protruding outward,
    상기 본체부의 내측면에는 내측으로 오목하게 절개되며 일정 폭을 구비하여 상기 체결돌기가 삽입되며 상기 체결돌기의 이동을 제한하는 체결홈이 형성되어 있는 것을 특징으로 하는 혈장추출키트.Plasma extraction kit characterized in that the inner surface of the main body portion is indented concave and has a predetermined width is inserted into the fastening protrusion and restricting the movement of the fastening projection.
  9. 제 7 항에 있어서, The method of claim 7, wherein
    일끝단은 상기 깔대기부에 연결되고 타끝단은 절곡되어 상기 덮개부의 나사산에 맞물리는 체결돌기가 형성된 기다란 막대형상의 연결날개부를 더욱 구비하는 것을 특징으로 하는 혈장추출키트.One end is connected to the funnel portion and the other end is bent plasma extraction kit further comprises a long rod-shaped connecting blade formed with a fastening projection engaging the thread of the cover portion.
  10. 제 9 항에 있어서, The method of claim 9,
    상기 연결날개부는, The connecting wing portion,
    일끝단에 T자 형상으로 형성된 제 1 날개부와, A first wing portion formed in a T shape at one end,
    타끝단에 상기 덮개부에 형성된 체결나사에 체결되는 연결돌기를 구비하는 것을 특징으로 하는 혈장추출키트.Plasma extraction kit characterized in that it comprises a connecting projection which is fastened to the fastening screw formed on the cover portion at the other end.
  11. 제 10 항에 있어서, The method of claim 10,
    상기 외통의 상단부분에는 T자 형상으로 절개되어 형성되며 상기 제 1 날개부가 체결되는 걸림고정홈을 더욱 구비하는 것을 특징으로 하는 혈장추출키트.Plasma extraction kit, characterized in that the upper end portion of the outer cylinder is formed by cutting in a T-shape and further comprising a locking fixing groove to which the first wing is fastened.
  12. 제 1 항에 있어서, The method of claim 1,
    혈액으로부터 혈장 성분을 추출하는 혈장 추출 키트에 의해, 주입된 혈액을 1차로 원심분리한 후 원심분리된 혈액의 PRP와 PPP와 적혈구로부터 2차 원심분리에 의해 혈장을 더욱 추출하는 2차 원심분리관을 더욱 포함하여 구성되는 것을 특징으로 하는 혈장추출키트.Secondary centrifuge tube which further extracts plasma by second centrifugation from PRP, PPP and erythrocytes of centrifuged blood after centrifuging the injected blood first by plasma extraction kit which extracts plasma components from blood. Plasma extraction kit, characterized in that further comprises a.
  13. 제 12 항에 있어서, The method of claim 12,
    상기 2차 원심분리관은 원통형 형상으로 형성되어 있고, The secondary centrifuge tube is formed in a cylindrical shape,
    상기 2차 원심분리관의 하단부에는 상부보다 직경이 작은 제 2 모세관과, A second capillary tube having a diameter smaller than an upper portion at a lower end of the secondary centrifuge tube,
    상기 제 2 모세관의 끝단부분에는 직경이 점차 작아지는 첨단부가 형성되어 있는 것을 특징으로 하는 혈장추출키트.Plasma extraction kit, characterized in that the tip portion of the second capillary tube is gradually reduced in diameter is formed.
PCT/KR2012/008148 2011-10-10 2012-10-09 Plasma extraction kit WO2013055070A2 (en)

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
KR1020110102863A KR101145173B1 (en) 2011-10-10 2011-10-10 Seperate type platelet rich plasma extraction kit
KR10-2011-0102863 2011-10-10
KR1020120108913A KR101267379B1 (en) 2012-09-28 2012-09-28 Platelet rich plasma extraction kit
KR10-2012-0108913 2012-09-28

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WO2013055070A3 WO2013055070A3 (en) 2013-07-04

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IT201800007617A1 (en) * 2018-07-30 2020-01-30 Vettorazzo Marco SEPARATOR KIT FOR THE EXTRACTION OF PLASMA RICH IN PLATES AND PROCEDURE FOR USING THE KIT
FR3110390A1 (en) 2020-05-20 2021-11-26 Cellquest Device for separating and recovering blood fractions
CN115870109A (en) * 2022-12-07 2023-03-31 上海医涯医疗科技有限公司 Horizontal centrifugal rotor, cell separation device and method

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KR20110009651A (en) * 2010-12-31 2011-01-28 주식회사 메디사랑 A blood separating vial, a blood concentrating vial for extracting platelet rich plasma and a method for extracting prp using the same
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IT201800007617A1 (en) * 2018-07-30 2020-01-30 Vettorazzo Marco SEPARATOR KIT FOR THE EXTRACTION OF PLASMA RICH IN PLATES AND PROCEDURE FOR USING THE KIT
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CN115870109B (en) * 2022-12-07 2023-08-22 上海医涯医疗科技有限公司 Horizontal centrifugal rotor, cell separation device and method

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