Body fluid separation device

CN113289773BActive Publication Date: 2026-08-18REV MED INC
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Patent Information

Application Number
CN202110485763.X
Authority / Receiving Office
CN · China
Patent Type
Patents(China)
Current Assignee / Owner
Priority Date
2018-01-12
Filing Date
2018-11-29
Publication Date
2026-08-18
Estimated Expiration
2038-11-29

AI Technical Summary

Technical Problem

[0016]但是,为了利用这种以往的血液分离装置来分离浓缩血小板,在将通过注射器收集的血液注入于试剂盒内部的过程中,需要在完全开放形成于试剂盒外部面的开口部的状态下进行,并且在注入血液之后需要利用额外的密封件以可分离的方式对开口部进行密封处理,因而当注入血液时空气通过完全开放的开口部大量流入,从而与作为离心分离对象物的血液相接触,由此可能使血液受到污染

Benefits of technology

[0040] According to the present invention as described above, the following effects are achieved.

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Abstract

A body fluid separation device includes a first sealing cap having a center with an elastic body, a first cylindrical housing having one end screwed to the first sealing cap and having an internal partition forming a first connecting hole, a center cylindrical housing filled with a body fluid having one end screwed to the other end of the first cylindrical housing and having a center partition forming a communicating hole, a second cylindrical housing having one end screwed to the other end of the center cylindrical housing and having a second connecting hole, a second sealing cap screwed to the other end of the second cylindrical housing, and a control unit including a first stopper rod connecting or blocking a first space and an internal space of the center cylindrical housing and a second stopper rod connecting or blocking a second space and the internal space of the center cylindrical housing, a coupling end of the first stopper rod being fitted to one end of a fixing hole of a stopper frame portion of the center partition, a free end extending toward the first connecting hole opening and closing the first connecting hole, and a coupling end of the second stopper rod being fitted to the other end of the fixing hole, a free end extending toward the second connecting hole opening and closing the second connecting hole.
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Description

Technical Field

[0001] This invention relates to an apparatus for separating bodily fluids such as blood or bone marrow sequentially based on their specific gravity difference after centrifugation. More specifically, it relates to a bodily fluid separation apparatus in which, when blood or bone marrow collected by a syringe is injected and supplied, contamination of the bodily fluids being separated is fundamentally prevented by blocking the inflow of external air into the interior. The process of converting the vacuum atmosphere of the separation space to atmospheric pressure after centrifugation minimizes the inflow of external air into the interior and can be performed simply and quickly. Background Technology

[0002] Generally speaking, body fluids refer to the fluids within the body, such as blood, lymph, and tissue fluid. Blood can be broadly divided into blood cells, which are solid components, and plasma, which is a liquid component. Blood cells are formed from red blood cells, white blood cells, and platelets, while plasma is mainly composed of water and contains essential blood clotting factors and electrolytes necessary for maintaining life.

[0003] As a mixture of multiple components, blood is widely used for various medical purposes, including processes that extract specific components by separating the blood. These processes can be used to separate the desired components for therapeutic purposes through blood centrifugation using a centrifuge and processes that utilize specific compositions.

[0004] In the process of separating blood by centrifugation, the blood is rotated at a specified speed to separate layers by utilizing the weight difference of the various components that make up the blood. In the case of centrifugation, the heaviest red blood cells form the lower layer, and from the lower layer upwards along the height direction, the separation layers are formed in the order of white blood cells, plasma, and serum.

[0005] Platelets rich in growth factors exist in blood plasma, which is divided into platelet-rich plasma (PRP) and platelet-poor plasma (PPP).

[0006] On the other hand, in the separated plasma layer, platelet-rich plasma called PRP is located in the lower part of the separated plasma layer and contains growth factors such as cytokines, platelet-derived factor (PDGF), transforming growth factor-β1 (TGF-BETA1), and von Ebner gland protein (VEGP). According to the research papers and other materials, the above-mentioned platelet-rich plasma has achieved good results, especially in the treatment of skin diseases and wound healing.

[0007] Furthermore, in the separated plasma layer, platelet-deficient plasma, known as PPP, is used as an autologous blood filler or autologous plasma-derived cosmetics.

[0008] Platelet-rich plasma (PRP) comprises only about 1% of the collected blood and is difficult to collect due to its high viscosity and adhesion to red blood cells. While direct implantation of PPP into painful areas, such as the inner knee, ligaments, and muscles, can stimulate surrounding stem cells to promote cell growth for therapeutic purposes, its scarcity and attachment to red blood cells make collection challenging. Furthermore, the presence of red blood cells can cause significant pain and inflammation. Therefore, the focus is on techniques that collect PPP other than red blood cells.

[0009] However, in the past, the extraction process of specific components such as platelets from blood was very cumbersome and inconvenient.

[0010] That is, in order to extract concentrated platelets, the process includes a first and second centrifugation process for concentration. In this process, after the blood is injected into the lower liquid chamber of the first separation container which has upper and lower liquid chambers, the first separation container containing the blood is subjected to a first centrifugation, and the white blood cells and erythrocyte sedimentation rate (ESR) buffy coat layer separated in the first centrifugation process are pushed to the upper liquid chamber to move them.

[0011] Next, the white blood cells and erythrocyte sedimentation rate (ESR) brown layer in the upper liquid chamber are transferred to the second separation container, and a second centrifugation and concentration process is performed to extract concentrated platelets.

[0012] At this point, not only is there a loss during the process of transferring the separated layer of blood from the first centrifugation to the second separation container, but the first and second centrifugation processes are also cumbersome and time-consuming.

[0013] Furthermore, the process of centrifuging specific blood components has been time-consuming in the past, which has made it difficult to quickly and safely inject the separated specific components, such as concentrated platelets, directly into the target patient after collecting blood directly from the patient and centrifuging to separate them.

[0014] Patent Document 1: KR10-1170028B1

[0015] Patent document 1, applied for and registered by the applicant of this invention, discloses a separation device that can perform two centrifugal separations without exposing the collected blood to the atmosphere.

[0016] However, in order to separate concentrated platelets using this conventional blood separation device, the process of injecting blood collected by a syringe into the reagent kit must be carried out with the opening formed on the outer surface of the reagent kit completely open. After the blood is injected, the opening needs to be sealed in a separable manner using an additional seal. As a result, when the blood is injected, a large amount of air flows in through the completely open opening and comes into contact with the blood, which is the object to be centrifuged, thus potentially contaminating the blood.

[0017] Furthermore, the additional work of binding and securing the tape with sealing material for sealing the open opening to the outer periphery of the kit after blood injection is very cumbersome, and because the bound tape decomposes from the kit in the centrifuge, it causes a fatal problem of blood flowing out of the kit during centrifugation.

[0018] Furthermore, after the first and second centrifugation, in order to smoothly discharge the centrifuged components from the inside of the kit to the outside, it is necessary to untie the straps that are fixed in place to fully open the opening so that the atmosphere inside the kit, which is in a vacuum state, can be converted to atmospheric pressure. As a large amount of air flows in through the fully open opening, it causes contamination of the centrifuged components, which becomes the main reason for reducing the reliability of the collected separated components. Summary of the Invention

[0019] The problem the invention aims to solve

[0020] Therefore, the present invention is intended to solve the problems described above, and its object is to provide a body fluid separation device that, when blood collected by a syringe is injected and supplied, fundamentally prevents contamination of the centrifugation object by fundamentally blocking the internal inflow of external air, and minimizes the internal inflow of external air by converting the vacuum atmosphere of the separation space to atmospheric pressure after centrifugation, and can be operated simply and quickly.

[0021] The technical problems to be solved by this invention are not limited to those described above. Those skilled in the art can clearly understand other problems not covered in this invention through the following description.

[0022] Solution for solving the problem

[0023] As a specific solution for achieving the above-mentioned objectives, a preferred first embodiment of the present invention provides a body fluid separation device, which includes: a first sealing cap having an elastic body at the center of a main body; a first cylindrical outer shell, one end of which is threadedly connected to the first sealing cap, and an internal partition forming a through-hole inside the main body; a central cylindrical outer shell, one end of which is threadedly connected to the other end of the first cylindrical outer shell in a manner that allows for reciprocal threaded movement, and a central partition forming at least one through-hole inside the main body for filling with body fluid; a second cylindrical outer shell, one end of which is threadedly connected to the other end of the central cylindrical outer shell in a manner that allows for reciprocal threaded movement, and a second connecting hole inside the main body; and a second sealing cap, which is connected to the other end of the second cylindrical outer shell. One end is threaded; and a control unit, including a first stop rod and a second stop rod, wherein the engaging end of the first stop rod is detachably assembled to one end of a fixing hole formed in the stop frame portion of the central partition, and a free end extending a predetermined length toward the first connecting hole is used to open and close the first connecting hole; the engaging end of the second stop rod is detachably assembled to the other end of a fixing hole formed in the stop frame portion of the central partition, and a free end extending toward the second connecting hole is used to open and close the second connecting hole; the first stop rods selectively connect or block the internal space of the first space and the central cylindrical shell, and the second stop rods selectively connect or block the internal space of the second space and the central cylindrical shell.

[0024] Preferably, a press-in body is provided in a through-hole that penetrates the outer surface of one of the first cylindrical shell, the second cylindrical shell, and the central cylindrical shell, in a manner that makes it difficult to detach from the outside. This allows the injection needle of the syringe that has collected the body fluid to be injected into the centrifugal separation space formed by the first stop bar and the second stop bar blocking the first connecting hole and the second connecting hole before centrifugal separation.

[0025] More preferably, the outer surface of the housing used to form the through opening may include a cover member, which forms an exposure hole to be fixed to the outer surface of the housing, so as to cover and fix the end of the press-in body while exposing a portion of the end face of the press-in body to the outside.

[0026] Preferably, the second sealing cap may include: a second outer skirt that is threaded to the other end of the second cylindrical shell; a second inner skirt that extends toward the second cylindrical shell at a predetermined interval from the second outer skirt to form an annular groove for allowing the open other end of the second cylindrical shell to enter; and an integral baffle that closes the open end of the second inner skirt and enters the interior of the second cylindrical shell.

[0027] Preferably, the second sealing cap may include: a second outer skirt threadedly engaged with the other end of the second cylindrical shell; a second inner skirt extending toward the second cylindrical shell at a predetermined interval from the second outer skirt to form an annular groove for allowing the open other end of the second cylindrical shell to enter; and a movable baffle threadedly engaged in a manner capable of moving along the inner surface of the second inner skirt, closing the open end of the second inner skirt and entering the interior of the second cylindrical shell.

[0028] More preferably, an auxiliary baffle can be threadedly assembled in the second inner skirt so as to contact the movable baffle by means of a sealing O-ring component.

[0029] A preferred second embodiment of the present invention provides a body fluid separation device, comprising: a first sealing cap having an elastic body at the center of a main body; a first cylindrical outer shell, one end of which is threadedly connected to the first sealing cap, and an internal partition having a through-hole forming a first connecting hole inside the main body; a central cylindrical outer shell, one end of which is threadedly connected to the other end of the first cylindrical outer shell in a manner that allows it to move threadedly relative to the first cylindrical outer shell, and a central partition having at least one through-hole forming a through-hole inside the main body for filling body fluid; a second cylindrical outer shell, one end of which is threadedly connected to the other end of the central cylindrical outer shell in a manner that allows it to move threadedly relative to the first cylindrical outer shell, and a second connecting hole inside the main body; a cap connecting portion, wherein an internal partition extending from the inner surface of the hollow cylindrical body whose one end is threadedly connected to the other end of the second cylindrical outer shell forms at least one through-hole; and a third sealing cap, which is detachably connected to the other end of the cap connecting portion for selective opening. The system includes: a closed through-hole; a filter section disposed on the internal partition for filtering foreign matter contained in bodily fluids flowing in through the through-hole opened when the third sealing cap is separated; and a control section including a first stop rod and a second stop rod. The first stop rod has a detachable end assembled to one end of a fixing hole formed in the stop frame portion of the central partition, and a free end extending a predetermined length toward the first connection hole for opening and closing the first connection hole. The second stop rod has a detachable end assembled to the other end of a fixing hole formed in the stop frame portion of the central partition, and a free end extending toward the second connection hole for opening and closing the second connection hole. The first stop rod selectively connects or blocks the internal space of the first space and the central cylindrical shell, and the second stop rod selectively connects or blocks the internal space of the second space and the central cylindrical shell.

[0030] Preferably, the third sealing cap may include a sealing rod of a predetermined length, which is inserted into the interior of a hollow tube extending a predetermined length from the outer surface of the inner partition forming the through hole to seal the through hole.

[0031] More preferably, the third sealing cap may include a connecting tube with a height relatively smaller than that of the sealing rod, the connecting tube having an internal thread portion formed on the outside of the sealing rod that is threaded into the external thread portion of the outer surface of the hollow tube.

[0032] Preferably, the filter section may include: an elastic plate that is joined and fixed to the upper surface of the internal partition in a manner that covers the through hole; and a hemispherical filter body that has a flange on its outer edge that is integrally joined with the elastic plate so that the elastic plate and the internal partition are integrally formed by means of the internal partition.

[0033] More preferably, the elastic plate corresponding to the aforementioned through hole may include a slit cut in a straight line or a cross shape.

[0034] Preferably, the above-mentioned body fluid separation device may include: a configuration part, which is recessed to a predetermined depth on the outer surface of one of the first cylindrical shell, the second cylindrical shell and the central cylindrical shell; and a working body, which is assembled to the configuration part to form a communication port on the bottom surface of the configuration part that connects to the internal space of the shell, and after centrifugal separation, converts the centrifugal separation space formed by the first stop bar and the second stop bar blocking the first connection hole and the second connection hole from a vacuum atmosphere to an atmospheric pressure state.

[0035] More preferably, the working body may include: a threaded body having a specified length and threadedly engaging with the configuration part; and a cone disposed at the front end of the threaded body to transmit external force to the bottom surface of the configuration part to penetrate and form the communication port.

[0036] More preferably, the working body may include: a threaded body having a predetermined length and threadedly engaging with the configuration part; and a cone disposed at the front end of the threaded body to selectively open or close the communication port by contacting or separating it from a communication port pre-formed on the bottom surface of the configuration part.

[0037] Preferably, the first stop bar and the second stop bar may include: a first insertion bar and a second insertion bar, each having one end inserted into the first connecting hole and the second connecting hole respectively; a first fixing bar and a second fixing bar respectively assembled into the fixing holes formed in the stop frame portion of the central partition; and an annular first boss and a second boss formed in the boundary area between the first insertion bar and the second insertion bar and the first fixing bar and the second fixing bar, so as to be locked by contacting the fixing holes of the stop frame portion.

[0038] More preferably, the first fixing rod and the second fixing rod may include a pair of planar portions facing each other by cutting a portion of the main body, which overlap each other and are formed on the same end face as the end face of the fixing hole respectively corresponding to the fixing hole of the stop bracket portion. One side planar portion may include a plurality of locking portions protruding in a manner with a predetermined interval, and the remaining other side planar portion may include a plurality of locked portions that generate locking force by locking with the locking portions.

[0039] The effects of the invention

[0040] According to the present invention as described above, the following effects are achieved.

[0041] When injecting and supplying bodily fluids such as blood or bone marrow collected by a syringe into the centrifugal separation space, the contamination of the bodily fluids, which are the objects of centrifugation, can be fundamentally prevented by blocking the inflow of external air into the space. The process of converting the vacuum atmosphere of the separation space into an atmospheric pressure atmosphere after centrifugation minimizes the inflow of external air into the space and can be carried out simply and quickly. Attached Figure Description

[0042] Figure 1a This is a perspective view of the body fluid separation device according to the first embodiment of the present invention.

[0043] Figure 1b An exploded perspective view of the body fluid separation device according to the first embodiment of the present invention is shown.

[0044] Figure 2a A side view of the body fluid separation device of the first embodiment of the present invention, viewed from one side.

[0045] Figure 2b For along Figure 2a A longitudinal sectional view cut along line AA.

[0046] Figure 3a This is a side view of the body fluid separation device of the first embodiment of the present invention, viewed from the other side.

[0047] Figure 3b For along Figure 2a A longitudinal sectional view cut along the BB line.

[0048] Figure 4 a to Figure 4 c is a cross-sectional view showing various embodiments of the second cylindrical outer shell of the body fluid separation device applicable to the first embodiment of the present invention.

[0049] Figure 5a and Figure 5b Detailed diagram of the control unit of the body fluid separation device commonly applicable to the first and second embodiments of the present invention is shown.

[0050] Figure 6 A perspective view showing the combined state of the press-in body of the body fluid separation device applicable to the first embodiment of the present invention.

[0051] Figure 7 A perspective view showing the combined state of the working body of the body fluid separation device applicable to both the first and second embodiments of the present invention.

[0052] Figures 8a to 8f This is a diagram showing the usage state of the body fluid separation device according to the first embodiment of the present invention.

[0053] Figure 9a This is a perspective view of the body fluid separation device according to the second embodiment of the present invention.

[0054] Figure 9b An exploded perspective view of the body fluid separation device according to a second embodiment of the present invention is shown.

[0055] Figure 10a A side view of the body fluid separation device of the second embodiment of the present invention, viewed from one side.

[0056] Figure 10b For along Figure 10a A longitudinal sectional view cut along the CC line.

[0057] Figure 11a This is a side view of the body fluid separation device of the second embodiment of the present invention, viewed from the other side.

[0058] Figure 11b For along Figure 11a A longitudinal sectional view cut along the DD line.

[0059] Figure 12 An enlarged view of the sealing portion for opening and closing the body fluid separation device according to the second embodiment of the present invention is shown.

[0060] Figures 13a to 13f This is a diagram showing the usage state of the body fluid separation device according to the second embodiment of the present invention.

[0061] Explanation of reference numerals in the attached figures

[0062] 110: First sealing cap

[0063] 120: First cylindrical outer shell

[0064] 130: Central cylindrical outer shell

[0065] 140: Second cylindrical outer shell

[0066] 150: Second sealing cap

[0067] 150a: Cover connection part

[0068] 160: Control Department

[0069] 171: Indentation

[0070] 181: Working Body

[0071] 190a: Third sealing cap

[0072] 190b: Filter section

[0073] S: Centrifugal separation space

[0074] S1: First Space

[0075] S2: Second Space Detailed Implementation

[0076] Hereinafter, preferred embodiments that are readily implemented by those skilled in the art will be described in detail with reference to the accompanying drawings. However, in the process of describing the structural principles of the preferred embodiments of the present invention in detail, detailed descriptions related to relevant known functions or structures will be omitted where it is determined that such specific descriptions may unnecessarily obscure the spirit of the present invention.

[0077] Furthermore, throughout the accompanying drawings, the same reference numerals are used for parts that perform similar functions and roles.

[0078] Additionally, throughout the specification, when one part is described as "connected" to another part, this includes both "direct connection" and "indirect connection" where other components exist between them. Furthermore, when one part is described as "including" another structural element, unless otherwise stated otherwise, this does not mean that other structural elements are excluded, but rather that other structural elements may be included.

[0079] like Figure 1a As shown in Figure 3, the body fluid separation device 100 of the first embodiment of the present invention may include a first sealing cap 110 and a second sealing cap 150, a first cylindrical shell 120 and a second cylindrical shell 140, a central cylindrical shell 130 and a control unit 160, so that by using a centrifuge to sequentially perform a first centrifugation separation process and a second centrifugation separation process on body fluids such as blood, and separating the components contained in blood as body fluids in multiple layers according to the difference in specific gravity, specific components can be selected only.

[0080] In the first sealing cap 110, a central hole 113 is formed through the bottom surface of the upper center of the main body, which is recessed to a predetermined depth. An elastomer 115 made of rubber or other materials is provided in the central hole, thereby sealing the cap by combining with one end of the opening of the first cylindrical shell.

[0081] like Figure 1b , Figure 2b and Figure 3b As shown, this first sealing cap 110 can be formed by a cover component assembled by inserting the elastomer into the aforementioned central hole. The cover component includes: a first outer skirt 111 extending toward the aforementioned first cylindrical outer shell side and having an internal thread 111a formed on its inner circumferential surface; and a first inner skirt 112 extending with a length relatively shorter than that of the first outer skirt 111, such that the elastomer forms an elastically assembled central hole 113 on its bottom surface.

[0082] The aforementioned elastomer 115 may include: a first elastomer 116, which has an assembly groove 116a recessed on its outer surface to elastically engage with the aforementioned central hole 113; and a second elastomer 117, whose outer diameter is relatively larger than that of the first elastomer, thereby sealing the assembly outer surface by pressing it into the inner circumferential surface of one end of the opening of the first cylindrical outer shell 120.

[0083] Preferably, the assembly groove 116a is formed in the boundary region between the first elastomer and the second elastomer, thereby contacting the end of the first inner skirt to increase the sealing force of the elastomer. Preferably, an annular embossed portion 117a is formed on the outer surface of the second elastomer 117 in such a way that it is close to the inner surface of one end of the opening of the first cylindrical shell to increase the sealing force when combined with the first cylindrical shell.

[0084] Furthermore, preferably, the outer diameter of the second elastic body 117 is relatively larger than the inner diameter of the first cylindrical shell, so as to forcefully press it into the inner circumferential surface of one end of the opening of the first cylindrical shell 120.

[0085] like Figure 1b , Figure 2b and Figure 3b As shown, the first cylindrical outer shell 120 can be formed by a hollow cylindrical component. The hollow cylindrical component has an external thread 121a formed on the outer peripheral surface of its open end to be threadedly engaged with the first sealing cap, so as to be threadedly engaged with the internal thread 111a formed on the first outer skirt 111 of the first sealing cap.

[0086] The first cylindrical outer shell 120 is provided with an internal partition 122 that forms a first connecting hole 125 through the center of the main body. The internal partition can be formed from a plate that is generally circular in shape and extends from the inner surface of the first cylindrical outer shell toward the radial direction.

[0087] Preferably, the first connection hole 125 is formed in a hollow cylindrical body 126 that extends from the center of the internal partition toward the first sealing cap side at a predetermined height.

[0088] At this time, the hollow cylindrical body 126 that forms the first connecting hole 125 is formed at the apex of the inner partition on the conical end face whose outer diameter gradually decreases toward the first sealing cap side.

[0089] The outer surface of the other open end of the first cylindrical outer shell 120 may include another external thread 121b that can be threadedly engaged with the central cylindrical outer shell 130.

[0090] Thus, the first sealing cap 110 and the first cylindrical shell 120 are assembled with each other by a threaded connection. If the first connecting hole is blocked by inserting the first stop bar provided in the control part, a first space S1 is formed between the first sealing cap and the first cylindrical shell. The internal volume of the first space increases or decreases according to the mutual threaded movement between the first sealing cap 110 and the first cylindrical shell 120.

[0091] like Figure 1b , Figure 2b and Figure 3b As shown, the aforementioned central cylindrical outer shell 130 is a hollow cylindrical component, wherein an internal thread portion 131a is formed at the upper end of the drawing, which is an open end, so as to be assembled in a manner that allows the aforementioned first cylindrical outer shell to be threadedly moved, so as to be threadedly engaged with an external thread portion 121b formed on the outer surface of the lower end, which is the other end of the aforementioned first cylindrical outer shell 120.

[0092] This central cylindrical outer shell 130 has a central partition 132 inside the main body that forms at least one through hole 135 to be filled with a predetermined amount of blood, so that the blood and other bodily fluids collected by the syringe 10 can be centrifuged.

[0093] Preferably, an O-ring component 133a for sealing is provided near the threaded joint between the first cylindrical outer shell and the central cylindrical outer shell to prevent the contents from flowing out when centrifuging blood and other bodily fluids.

[0094] Furthermore, the central partition of the aforementioned central cylindrical outer shell 130 may include a stop bracket portion 136, which is capable of assembling and setting the first stop rod 161 and the second stop rod 162 of the aforementioned control portion 160.

[0095] like Figure 1b , Figure 2b and Figure 3b As shown, the second cylindrical outer shell 140 has an internal thread 141a formed on the upper outer peripheral surface of the open end, which is threaded to engage with the external thread 131b formed on the lower outer peripheral surface of the open other end of the central cylindrical outer shell 130, thereby assembling in a manner that allows it to move threadedly relative to the central cylindrical outer shell 130.

[0096] Inside the second cylindrical outer shell 140, a second connection hole 145 is provided inside the main body in such a way that it is arranged on the same vertical axis as the first connection hole. The second connection hole 145 is opened or closed by selectively blocking or opening the connection channel by the second stop bar 162 provided on the control unit 160.

[0097] The second connecting hole 145 is formed by a neck 142 extending from the inner surface of the second cylindrical shell toward the center along the upper end surface. Therefore, the second cylindrical shell 140 is in the shape of an hourglass with the second connecting hole formed through the center of the main body due to the neck 142.

[0098] Furthermore, preferably, a plurality of reinforcing ribs 149 are provided on the outer surface of the second cylindrical outer shell forming the aforementioned neck, so as to strengthen the neck where the inner and outer diameters are smaller.

[0099] Preferably, another sealing O-ring component 133b is provided near the threaded connection between the second cylindrical outer shell and the central cylindrical outer shell to prevent the contents from flowing out when centrifuging blood and other bodily fluids.

[0100] Thus, the two ends of the aforementioned central cylindrical shell 130 are threadedly connected to the first cylindrical shell 120 having the first connecting hole 125 and the second cylindrical shell having the second connecting hole, respectively. Inside the aforementioned central cylindrical shell 130, there is a control part 160 having a first stop bar 161 and a second stop bar 162 in opposite directions. If the connection channel is closed by simultaneously blocking the first connecting hole and the second connecting hole by the aforementioned first stop bar and the second stop bar, a centrifugal separation space S for injecting and filling blood and other bodily fluids is formed.

[0101] like Figure 1b , Figure 2b and Figure 3b As shown, the second sealing cap 150 has an internal thread 151a on its inner circumferential surface, such that the external thread 141b formed on the lower outer circumferential surface of the second cylindrical shell (as shown in the attached figure) is threadedly engaged with the upper end of the open end, thereby being threadedly assembled in a threaded engagement manner so that it can be threadedly moved relative to the second cylindrical shell.

[0102] The second sealing cap 150 may include: a second outer skirt 151, with an internal thread 151a formed on its inner circumferential surface in such a way as to be threadedly engaged with an external thread formed on the outer circumferential surface of the other end of the second cylindrical shell; a second inner skirt 152, extending toward the second cylindrical shell side at a predetermined interval from the second outer skirt, to form an annular groove for allowing the open other end of the second cylindrical shell to enter; and an integral baffle 154, protruding from the center, extending from the open end of the second inner skirt 152 to close the end and enter the interior of the second cylindrical shell.

[0103] Preferably, another sealing O-ring component 153 is provided near the threaded connection between the second cylindrical outer shell and the second sealing cap to prevent the contents from flowing out when centrifuging blood and other bodily fluids.

[0104] Therefore, when the connecting channel is closed by blocking the second connecting hole formed in the second cylindrical shell by the second stop bar, and the thread of the second sealing cap threaded to the other end of the second cylindrical shell is moved, the internal volume of the second space S2 formed between the second cylindrical shell and the second sealing cap can be adjusted by appropriate change according to the position of the integral baffle 154 that enters the interior of the second cylindrical shell together with the second sealing cap or retracts.

[0105] Among them, such as Figure 4 As shown in Figure a, the second inner skirt 152, the second outer skirt 151, and the integral baffle 154 in the second sealing cap 150 are connected to each other as a single unit, but this is not a limitation. Figure 4 As shown in b, the second sealing cap 150 may include: a second outer skirt 151, with an internal thread 151a formed on its inner circumferential surface to thread into an external thread formed on the outer circumferential surface of the other end of the second cylindrical shell; a second inner skirt 152, extending toward the second cylindrical shell side at a predetermined interval from the second outer skirt to form an annular groove for allowing the open other end of the second cylindrical shell to enter; and a movable baffle 154a, with an external thread formed on its outer circumferential surface to thread into an internal thread formed on the inner surface of the second inner skirt 152 to close the open end of the second inner skirt and move along the individual thread of the second inner skirt, and enter the interior of the second cylindrical shell together with the second sealing cap.

[0106] In this case, after the internal volume of the second space S2 formed between the second cylindrical shell and the second sealing cap is adjusted for the first time by moving the thread of the second sealing cap which is threaded to the other end of the second cylindrical shell, the internal volume of the second space S2 is adjusted for the second time more accurately by moving the movable baffle 154a into or back into the second cylindrical shell.

[0107] At this time, an auxiliary baffle 154b is assembled on the second inner skirt 152, which is threadedly engaged with the movable baffle 154a. The auxiliary baffle 154b is formed with an external thread on its outer peripheral surface by means of at least one sealing O-ring component 154c to contact the movable baffle, so as to move independently along the threaded part of the second inner skirt. Thus, the threaded engagement between the movable baffle and the second inner skirt, which is adjusted in position for the second time, prevents leakage of blood and other bodily fluids stored in the centrifugal separation space during centrifugal separation.

[0108] Preferably, individual handles are provided on the outer surfaces of the movable baffle and the auxiliary baffle, making it easy for the user to perform rotation operations.

[0109] And, as Figure 4 a and Figure 4 As shown in b, the second sealing cap 150 is illustrated and described with an integral baffle or a threaded movable baffle integrally assembled to the open end of the second inner skirt that enters the interior of the second cylindrical shell, but is not limited thereto. Figure 4 As shown in c, a second outer skirt 151 has an inner thread 151a formed on its inner circumferential surface in such a way that it is threadedly engaged with an external thread formed on the outer circumferential surface of the other end of the second cylindrical shell. The skirt includes a base plate 154d that extends integrally to close the open end of the second outer skirt. The base plate may include a groove formed by recessing in a way that can expand its volume on its inner surface.

[0110] like Figure 5a and Figure 5b As shown, the control unit 160 may include a first stop bar 161 and a second stop bar 162 extending in opposite directions from the central partition 132 disposed on the central cylindrical housing 130 toward the first connection hole 125 and the second connection hole side 145 for a predetermined length.

[0111] When the first cylindrical shell and the second cylindrical shell move relative to the central cylindrical shell, the first stop bar 161 and the second stop bar 162 selectively block or open the first connecting hole and the second connecting hole to form a first space S1 between the first sealing cap 110 and the first cylindrical shell 120 or a second space S2 between the second sealing cap 150 and the second cylindrical shell 140, and form a centrifugal separation space in the internal space of the central cylindrical shell corresponding to the first space and the second space, thereby selectively connecting them in a connected manner or blocking the connection channel in accordance with the centrifugal separation process.

[0112] Furthermore, the central partition 132 of the aforementioned central cylindrical outer shell 130 may include a stop bracket portion 136, which is capable of being assembled and provided with a through-hole 136a for fastening the respective ends of the first stop rod and the second stop rod into the assembly, so that the positions of the first stop rod and the second stop rod can be vertically fixed relative to the horizontal central partition by correspondingly inserting the respective ends of the first stop rod 161 and the second stop rod 162.

[0113] like Figure 5a and Figure 5b As shown, the first stop bar 161 and the second stop bar 162 have a first insertion bar 161a and a second insertion bar 162a, each with one end inserted into the first connecting hole 125 and the second connecting hole 145 respectively. They may include a first fixing bar 161b and a second fixing bar 162b that extend a predetermined length from the other end of the first insertion bar and the second insertion bar respectively and are respectively assembled into the fixing hole 136a of the stop bracket portion 136.

[0114] An annular first boss 161c and second boss 162c are formed in the boundary region between the first insertion rod 161a and the second insertion rod 162a and the first fixing rod 161b and the second fixing rod 162b, so as to be locked and controlled by contacting the fixing hole 136a of the stop bracket portion.

[0115] The first and second insertion rods are integrally formed with the first and second annular bosses 161c and 162c at the boundary between the first and second insertion rods and the first and second fixing rods, but this is not a limitation. The annular component may be used, which includes an internal thread portion that is threaded to an external thread portion formed at the middle of the length of the first and second stop rods.

[0116] Furthermore, the first fixing rod 161b and the second fixing rod 162b may each include a half-cut planar portion that faces each other as part of the main body, which are respectively aligned with the fixing holes 136a of the stop bracket portion 136 and are shaped to match the end face shape of the fixing holes.

[0117] At this time, when the fixing hole is circular, the first fixing rod and the second fixing rod can be respectively shaped into semi-circular end faces to fit together in the fixing hole as circular rods and be inserted and fixed. However, it is not limited to this. The end face shapes of the first fixing rod and the second fixing rod can be changed according to the shape of the fixing hole.

[0118] One side of a pair of opposing planar portions in the first and second fixing rods includes a plurality of locking portions 163a protruding at predetermined intervals, and the remaining other side of the planar portion may include a locked portion 163b that generates a locking force by locking with the locking portions.

[0119] The aforementioned locking portion 163a and the locked portion 163b may be formed by protrusions in the shape of opposing upper end faces or by locking grooves formed by recesses and locking portions disposed thereon.

[0120] Preferably, the locking portion is positioned between adjacent locking portions to generate a locking force, thereby preventing slippage between the opposing planar portions of the first and second fixing rods that overlap and fit together within the fixing hole of the stop bracket portion.

[0121] Therefore, the insertion depth in the fixing holes is adjusted by inserting the first fixing rod 161b and the second fixing rod 162b, which are respectively inserted into the fixing holes of the stop bracket 136 and overlap each other, so as to change the locking position between the locking part and the locked part, thereby extending or restoring the total length of the first stop rod and the second stop rod assembled in the stop bracket to the original state.

[0122] Furthermore, the end of the second stop bar has an insertion portion 162d with an outer diameter that is relatively larger than the outer diameter of the second fixing rod 162b, which is inserted into the second connecting hole.

[0123] On the other hand, such as Figure 6 As shown, the outer surface of one of the first cylindrical shell, the second cylindrical shell, and the central cylindrical shell includes a through-hole 172 formed with an inner diameter of a predetermined size, so that after a predetermined amount of blood to be centrifuged and separated is collected from the patient's body using the injection needle of a syringe, the collected blood and other bodily fluids can be injected into the interior of the central cylindrical shell for supply. The through-hole 172 may include a press-fit body 171 that is press-fitted in a manner that makes it difficult to detach from the outside.

[0124] The aforementioned press-in body 171 is formed of a rubber material with elastic resilience to allow the insertion of the aforementioned injection needle and block the inflow of external air into the interior. Preferably, it is formed of a cylindrical component whose outer surface is pressed against the inner surface of a hollow extension that extends a predetermined length from the aforementioned through-hole toward the interior of the housing.

[0125] Preferably, an embossed portion 171a is formed protruding from the outer surface of the press-in body 171 formed from the above-mentioned cylindrical component, so as to improve the adhesion to the inner surface of the hollow extension of the through-hole.

[0126] And, as Figure 6 As shown, the outer surface of the housing used to form the through-hole 172 may include a cover member 173, which forms an exposure hole 173a through the cover member to be fixed to the outer surface of the housing, so as to cover and fix the end of the press-in body while exposing a portion of the end face of the press-in body 171 to the outside.

[0127] At this time, the through opening 172 formed in the first cylindrical shell 120 is shown and explained, but it is not limited to this. It may be selectively provided in the central cylindrical shell 130 or the second cylindrical shell 140 which is combined with the first cylindrical shell.

[0128] Thus, the syringe needle for collecting bodily fluids such as blood is inserted through the end face of the press-in body exposed by the exposed hole of the aforementioned cap component, thereby injecting blood into the interior of the central cylindrical shell to supply and fill the centrifugal separation space. When blood is injected through the syringe, preferably, the aforementioned centrifugal separation space is formed with the first connecting hole and the second connecting hole open.

[0129] Furthermore, after the injection needle is pulled out from the press-fit body, the penetration mark of the injection needle is sealed in its original state by the elastic restoring force of the press-fit body formed of rubber material, thereby safely and naturally blocking the inflow of external air into the interior of the central cylindrical shell.

[0130] And, as Figure 2b and Figure 7 As shown, the outer surface of one of the first cylindrical shell, the second cylindrical shell, and the central cylindrical shell includes a configuration portion 182 recessed inward to a predetermined depth, which may include a working body 181. The working body 181 is assembled inside the configuration portion 182 to form a communication port 182a that communicates with and connects to the internal space of the corresponding shell.

[0131] By rotating the working body assembled in the above configuration section, a communication port is opened to form a connection with the outside air. Thus, when blood or other centrifugation objects are forcibly injected into the centrifugation space using the injection needle of the syringe that penetrates the above injection body, the centrifugation space can be connected to the outside air so that the injection work can be carried out without the internal pressure rising.

[0132] Furthermore, once the injection work using the syringe needle is completed, centrifugal separation is performed after sealing the communication port by rotating the working body.

[0133] Furthermore, by rotating the aforementioned working body, a connection port is formed to communicate with the outside air. After the centrifugal separation of blood and other bodily fluids B1, the centrifugal separation space S formed by the first stop bar and the second stop bar blocking the first and second connecting holes is connected to the outside air, allowing the centrifuged blood to be discharged to the outside.

[0134] The aforementioned working body 181 includes an external thread portion formed on the outer peripheral surface and threaded to the internal thread portion formed on the inner surface of the aforementioned configuration portion, and a threaded body that moves a predetermined length of thread during forward or reverse rotation. The front end of the aforementioned threaded body may include a cone 181a that forcibly penetrates the aforementioned communication port 182a by transmitting the external force generated during the rotation operation to the closed surface of the aforementioned configuration portion.

[0135] Furthermore, the front end of the aforementioned threaded body may include a cone 181a that selectively opens or closes the communication port by contacting or separating it from the communication port 182a pre-through-formed on the closed surface of the aforementioned configuration portion.

[0136] At this time, the cone 181a provided at the front end of the working body is formed of a material with a hardness relatively less than that of the outer shell. Preferably, its outer diameter is relatively larger than the inner diameter of the opening, so that the opening can be flexibly closed by the external force caused by the threaded body moving during forward or reverse rotation.

[0137] Conversely, in the case where the connection is opened by a cone of a working body that moves by a thread because the aforementioned connection has not been formed, the cone may be formed of a material with a hardness relatively higher than that of the outer shell or may be coated.

[0138] The outer end of the working body 181 includes a head 183 with an outer diameter that is relatively larger than the outer diameter of the working body, so as to facilitate the rotation operation of the threaded body that is threadedly engaged with the internal thread of the configuration part. The outer surface of the housing corresponding to the head may include a sealing O-ring 184.

[0139] Therefore, if the above-mentioned working body is rotated to form the above-mentioned communication port on the bottom surface of the configuration part by means of the striking body, or to open the communication port that has been pre-formed on the bottom surface of the configuration part, the centrifugal separation space formed in the inner space of the central cylindrical shell can be easily and quickly connected to the outside and converted to atmospheric pressure. Thus, it is possible to flexibly perform the work of injecting blood and other bodily fluids into the centrifugal separation space before centrifugal separation and the work of discharging specific components in the centrifuged blood to the outside after centrifugal separation.

[0140] Furthermore, by rotating the working body, the striking body is inserted into the connecting port that is formed through the closed surface of the configuration part to block the connection channel, thereby converting the centrifugal separation space into a vacuum atmosphere and eliminating the risk of body fluid flowing out through the connecting port during the second centrifugal separation.

[0141] The process of centrifuging blood, the object of centrifugation, in two steps using the body fluid separation device 100 of the first embodiment having the above structure will be described.

[0142] First, such as Figure 8a As shown, with the first connection hole 125 of the first cylindrical shell 120 and the second connection hole 145 of the second cylindrical shell 140 open, the bodily fluid B1 collected inside the syringe 10 is injected and filled to a predetermined amount through the injection needle 12, which is forcibly inserted through the press-in body 171 provided on the outer surface of the first cylindrical shell 120.

[0143] The aforementioned centrifugal separation space S is connected to the outside air through a communication port opened by the rotation operation of the aforementioned working body, thereby flexibly performing injection work using an injection needle.

[0144] The example described is the injection of blood, which is a bodily fluid, using the syringe described above, and the maintenance of the open state of the first and second connecting holes after the injection. However, it is not limited to this. After the injection is completed, the first insertion rod 161a of the first stop rod 161 of the control part located at the inner center of the central cylindrical shell 130 is inserted into the first connecting hole 125 by the threaded movement of the first cylindrical shell 120, which rotates relative to the central cylindrical shell 130. This closes the first connecting hole 125.

[0145] Furthermore, with the second connecting hole 145 of the second cylindrical outer shell open, thereby connecting the centrifugal separation space S with the second space S2, the body fluid B1 is centrifuged for the first time using a centrifuge.

[0146] If the first centrifugation is completed, then as follows Figure 8bAs shown, the blood cell component C and plasma component P contained in the body fluid, which is blood after centrifugation, separate in the upward and downward direction due to their difference in specific gravity. The boundary layer between the blood cell component C and plasma component P, which are separated and stacked in the upward and downward direction due to their difference in specific gravity, is formed on the second connecting hole 145 or its upper or lower side, depending on the amount of centrifugation.

[0147] At this point, since the first cylindrical shell, the second cylindrical shell, the hollow cylindrical shell, the first sealing cap, and the second sealing cap are made of transparent material, the separation layer formed by the blood cell components and plasma components separated by the first centrifugation can be distinguished by the naked eye according to the color exposed to the outside.

[0148] In this state, such as Figure 8c As shown, the operator moves the lower side second sealing cap 150 in a specified amount relative to the second cylindrical outer shell 140 toward the forward or reverse thread, thereby manually adjusting the position of the second sealing cap relative to the second cylindrical outer shell so that the boundary layer between the blood cell component C and the plasma component P is located at the center or lower end of the second connecting hole.

[0149] Next, as Figure 8d As shown, when the second connecting hole 145 is closed by the second insertion rod of the second stop rod, since only the blood cell component C, which is the object to be separated and removed, remains in the second space formed between the second cylindrical shell and the second sealing cap, the blood cell component that has been separated by centrifugation is separated and removed by disassembling the second sealing cap 150 from the second cylindrical shell.

[0150] Therefore, only plasma component P remains in the centrifugal separation space S of the aforementioned central cylindrical shell, and the aforementioned second space S2 is emptied because blood cell component C is separated and removed.

[0151] In this state, such as Figure 8e As shown, if the first sealing cap and the first cylindrical shell are reversed by 180 degrees to make the first sealing cap and the second cylindrical shell the upper parts, the plasma component P remaining after the first centrifugation will move into the first space S1 through the open first connection hole.

[0152] At this time, the total volume of plasma component P, which is the object of the second centrifugation, may be the same as or different from the total volume of the first space S1. In order to adjust the concentration of platelet-rich plasma layer P1, which is the final result of the second centrifugation, by rotating the first sealing cap, the staff can appropriately increase or decrease the total volume of the first space.

[0153] At this point, the platelet-rich plasma layer P1, which is the platelet-concentrated plasma from the second centrifugation, and the platelet-poor plasma layer P2, which is the platelet-deficient plasma, are separated and distinguished by the naked eye through a first cylindrical shell, a second cylindrical shell, a hollow cylindrical shell, a first sealing cap, and a second sealing cap, all made of transparent material.

[0154] Next, as Figure 8f As shown, the platelet-poor plasma layer P2, which is relatively light platelet-poor plasma, is located in the upper centrifugation separation space S, while the platelet-rich plasma layer P1, which is heavy platelet-concentrated plasma, is located in the lower first space S1.

[0155] In this state, if the first cylindrical outer shell is rotated relative to the central cylindrical outer shell to close the first connecting hole 125 by means of the first insertion rod of the first stop rod, then the second separation is performed by isolating only the platelet-rich plasma layer P1, which is the object of separation formed in the first space S1 between the first cylindrical outer shell and the first sealing cap.

[0156] The platelet-rich plasma layer P1, which is the final object of centrifugation, is extracted and recovered from the outside using the injection needle of another syringe inserted through the elastic body 115 of the first sealing cap 110. This concludes the centrifugation of blood as a body fluid.

[0157] like Figures 9a to 12 As shown, the body fluid separation device 100a of the second embodiment of the present invention may include a first sealing cap 110 and a third sealing cap 190a, a first cylindrical shell 120 and a second cylindrical shell 140, a central cylindrical shell 130, a cap connecting part 150a, a control part 160 and a filter part 190b, so that by using a centrifuge to sequentially perform a first centrifugation separation process and a second centrifugation separation process on body fluids such as bone marrow, and separating the components contained in bone marrow as body fluids in multiple layers according to the difference in specific gravity, specific components can be selected only.

[0158] The first sealing cap, the first cylindrical outer shell 120 and the second cylindrical outer shell 140, the central cylindrical outer shell 130 and the control unit 160 have the same structure as those in the first embodiment, and are therefore given the same reference numerals, and detailed descriptions thereof are omitted below.

[0159] like Figure 9b , Figure 10b and Figure 11b As shown, the cover connecting portion 150a has an internal thread portion 151a formed on its inner circumferential surface, such that the external thread portion 141b formed on the lower outer circumferential surface of the drawing, which is the open other end of the second cylindrical outer shell 140, is threadedly engaged with the upper end of the open end, thereby being threadedly assembled in a threaded engagement manner so that it can be threadedly moved with the second cylindrical outer shell.

[0160] This cover connection 150a includes: a hollow cylindrical body 151b, which forms an internal thread 151a on the inner circumferential surface at one end in such a way as to be threadedly engaged with the external thread of the second cylindrical outer shell 140; and an internal partition 155, which extends from the inner surface of the main body of the hollow cylindrical body, and forms at least one through hole 156 at the center of the internal partition 155.

[0161] The aforementioned third sealing cap 190a is a cap component that is detachably attached to the lower end of the cap connection portion, and is used to selectively open and close the through hole 156 formed in the internal partition 155 of the hollow cylindrical body 151b provided in the cap connection portion 150a.

[0162] The upper surface center of the main body of this cover component 192 may include a sealing rod 192b of a predetermined length, which is inserted into the interior of a hollow tube 155b extending a predetermined length from the lower surface of the inner partition that forms the through hole to seal the through hole 156.

[0163] The sealing rod 192b may be formed by a rod component, the outer diameter of which is approximately the same as the inner diameter of the through hole, and the rod component extends a predetermined height from the upper surface of the third sealing cap, which corresponds to the internal partition, in the attached drawing.

[0164] Furthermore, the cap component 192 of the third sealing cap 190a forms a connecting tube 192a of a predetermined height on the outer side of the sealing rod. The connecting tube 192a forms an internal thread on its inner circumferential surface in such a way that it is threadedly engaged with the external thread 155c formed on the outer surface of the hollow tube. The height of the connecting tube 192a is relatively smaller than the height of the sealing rod 192b.

[0165] The lower end of the other end of the cap connection 150a includes an inner extension 151c extending downward, which generates a tight fit by contacting an outer curved portion that extends upward from the outer edge of the cap component of the third sealing cap 190a toward the cap connection at a predetermined height.

[0166] Furthermore, preferably, a configuration portion for configurable at least one sealing O-ring component 195 is formed in a recessed manner on the outer surface of the aforementioned inner extension or the inner surface of the aforementioned outer bend.

[0167] At this time, the outer diameter of the inner extension 151c is relatively smaller than the inner diameter of the cover component 192, so that when the cover connecting portion 150a is combined with the third sealing cap 190a, the outer surface of the outer curved portion is consistent with the outer surface of the hollow cylindrical body of the cover connecting portion.

[0168] Therefore, the through hole of the internal partition plate inside the hollow cylinder of the cover connection is sealed by the sealing rod. When the third sealing cap and the cover connection are assembled by the threaded connection between the internal thread of the connecting tube provided on the outside of the sealing rod and the external thread of the hollow tube extending from the internal partition plate, the sealing rod is inserted into the through hole of the internal partition plate.

[0169] Furthermore, when the syringe with the injection needle is used to inject bodily fluids such as bone marrow into the centrifugal separation space after the third sealing cap is separated, the external thread portion formed on the outer surface of the hollow tube combines with the internal thread portion formed at the injection port of the syringe 20.

[0170] The filter section 190b is disposed on the internal partition 155 provided in the cover connection section 150a, and is used to filter foreign matter contained in the body fluid flowing into the second space S2 formed between the second cylindrical outer shell 140 and the cover connection section 150a through the through hole 156 which is opened when the cover connection section is separated from the third sealing cap 190a.

[0171] In this case, if the aforementioned bodily fluid is bone marrow, the foreign matter filtered through the aforementioned filtration section may be bone fragments included during bone marrow collection.

[0172] This filter section 190b may include: an elastic plate 193, which is joined and fixed to the upper surface of the inner partition 155 by means of a bonding material such as a welding agent to cover the through hole 156; and a hemispherical filter body 191, which has a flange portion 191a at its outer edge that is integrally joined with the elastic plate so that the elastic plate and the inner partition are integrally formed by means of the elastic plate.

[0173] At this time, the hemispherical filter 191 forms multiple filter holes of a specified size through the outer surface of the hemispherical end face, thereby filtering and capturing foreign objects such as bone fragments with relatively large particle size in the body fluid B2 injected into the second space through the injection port 22 of the syringe 20 which is combined with the hollow tube forming the through hole, and injecting only the body fluid such as bone marrow, which is the object to be separated, into the second space.

[0174] The aforementioned elastic plate 193 may be formed from a pad made of thin silicon material. A slit 193a cut in a straight line or cross shape is pre-formed in the center of the elastic plate corresponding to the aforementioned through hole 156. This allows bodily fluid discharged through the injection port by applying pressure to pass through when the hollow tube 155b extending from the aforementioned through hole 156 after the aforementioned third sealing cap 190a is separated and combined with the front end of the injection port 22 of the syringe 20.

[0175] Furthermore, a locking portion 155a protruding to a predetermined height is provided on the outer edge of the aforementioned internal partition 155 to contact the flange portion 191a formed on the outer edge of the aforementioned hemispherical filter 191a. This makes it easier to set the position of the aforementioned hemispherical filter 191 and to fix the aforementioned elastic plate in the internal partition when the work of fixing the aforementioned hemispherical filter 191 to the upper surface of the internal partition is carried out.

[0176] The centrifugation process of bone marrow, the object of centrifugation, is described in two steps using the body fluid separation device 100a of the second embodiment described above.

[0177] First, such as Figure 13a As shown, the first connecting hole 125 of the first cylindrical outer shell 120 and the second connecting hole 145 of the second cylindrical outer shell 140 are separated from the third sealing cap 190a assembled to the cover connecting portion 150a in the open state, thereby exposing the hollow tube 155b extending toward the lower surface of the inner partition 155 disposed inside the cover connecting portion to the outside.

[0178] In this state, the bone marrow and other bodily fluids B2 collected inside the syringe 20 after the injection needle has been removed are injected into the centrifugal separation space S through the through hole 156 formed in the internal partition via the connection between the injection port 22 of the syringe 20 and the hollow tube of the internal partition, and fill a predetermined amount.

[0179] At this time, the centrifugal separation space S is connected to the outside air through a communication port opened by the rotation operation of the working body, thereby flexibly performing injection work using an injection needle.

[0180] That is, the internal thread portion formed at the injection port of the syringe 20 is combined with the external thread portion formed on the outer surface of the hollow tube 155b, thereby connecting the syringe to the hollow tube.

[0181] In this state, the bone marrow and other bodily fluids B2 injected under pressure by the piston of the syringe 20 are filtered out of bone fragments and other foreign objects as they pass through the hemispherical filter facing the through hole 156 of the internal partition. Only the filtered bodily fluid is injected into the centrifugal separation space and filled to a specified amount.

[0182] At this time, the through hole 156 is covered by the elastic plate 193 provided on the hemispherical filter body 191, but the body fluid forcibly injected through the injection port 22 of the syringe 20 is opened in the slit 193a cut by the elastic plate in a straight line or cross shape, so as to flexibly carry out the body fluid injection work.

[0183] Next, once the work of injecting bodily fluid using the aforementioned syringe is completed, the syringe is separated and removed. Then, the sealing rod of the separated third sealing cap 190a is inserted into the hollow tube to seal the through hole 156. At the same time, the third sealing cap is reassembled in its original state at the lower end of the cap connection by threaded connection between the connecting tube 192a located outside the sealing rod 192b and the hollow tube 155b extending from the internal partition.

[0184] Furthermore, the second connecting hole 145 of the second cylindrical outer shell is opened, thereby connecting the centrifugal separation space S with the second space S2. With the connection port opened for injection work closed by the rotation operation of the working body, the body fluid B2 is centrifuged for the first time using a centrifuge.

[0185] If the first centrifugation is completed, then Figure 13b As shown, the blood cell component C and plasma component P contained in the centrifuged bone marrow fluid B2 separate in an upward and downward direction due to their difference in specific gravity. The boundary layer between the blood cell component C and plasma component P, which are separated and stacked in an upward and downward direction due to their difference in specific gravity, is formed on the second connecting hole 145 or its upper or lower side, depending on the amount of centrifugation.

[0186] At this point, since the first cylindrical shell, the second cylindrical shell, the hollow cylindrical shell, the first sealing cap, and the third sealing cap are made of transparent material, the separation layer formed by the blood cell components and plasma components separated by the first centrifugation can be distinguished by the naked eye according to the color exposed to the outside.

[0187] In this state, such as Figure 13b and Figure 13c As shown, the operator moves the lower side cover connecting part 150a in a specified amount relative to the second cylindrical outer shell 140 toward the forward or reverse thread, thereby manually adjusting the position of the cover connecting part relative to the second cylindrical outer shell so that the boundary layer between the blood cell component C and the plasma component P is located at the center or lower end of the second connecting hole 145.

[0188] Next, as Figure 13d As shown, if the second cylindrical outer shell is rotated relative to the central cylindrical outer shell to close the second connecting hole 145 by the second insertion rod of the second stop rod, then since only blood cell components, which are the objects to be separated, remain in the second space S2 formed between the second cylindrical outer shell and the cover connection, the blood cell components separated by centrifugation are removed together with the foreign matter filtered by the hemispherical filter body by decomposing the third sealing cap combined with the cover connection 150a.

[0189] Therefore, only plasma component P remains in the centrifugal separation space S of the aforementioned central cylindrical shell, and the aforementioned second space S2 is emptied because blood cell component C is separated and removed.

[0190] In this state, such as Figure 13e As shown, if the first sealing cap and the first cylindrical shell are reversed by 180 degrees to make the first sealing cap and the second cylindrical shell the upper parts, the plasma component P remaining after the first centrifugation will move into the first space S1 through the open first connection hole.

[0191] At this time, the total volume of plasma component P, which is the object of the second centrifugation, may be the same as or different from the total volume of the first space S1. In order to make the boundary layer after the second centrifugation located in the first connecting hole by rotating the first sealing cap, the staff can appropriately increase or decrease the total volume of the first space.

[0192] Furthermore, in order to adjust the concentration of the platelet-rich plasma layer P1, which is the final product, the adjustment is performed by rotating the first sealing cap.

[0193] Next, if a second centrifugation separation process of plasma components is carried out in the centrifuge, the plasma components separated in the second centrifugation will be separated into a platelet-rich plasma layer P1, which is platelet-concentrated plasma, and anemic platelet-poor plasma layer P2, which is platelet-poor plasma, according to the difference in specific gravity. The boundary layer between the separated and stacked platelet-rich plasma layer P1 and anemic platelet-poor plasma layer P2 is formed at the first connecting hole or above or below it, depending on the number of plasma components separated by centrifugation.

[0194] At this point, the platelet-rich plasma layer P1, which is the platelet-concentrated plasma from the second centrifugation, and the platelet-poor plasma layer P2, which is the platelet-deficient plasma, are separated and distinguished by the naked eye through a first cylindrical shell, a second cylindrical shell, a hollow cylindrical shell, a first sealing cap, and a cap connection made of transparent material.

[0195] Next, as Figure 13f As shown, by moving the first sealing cap 110 in a predetermined amount toward the forward or reverse thread, the position of the first sealing cap can be manually adjusted in the same manner as in the first embodiment, so that the boundary layer between the platelet-rich plasma layer P1 and the anemic platelet-rich plasma layer P2 is located at the center or lower end of the first connecting hole 125. Thus, the anemic platelet-rich plasma layer P2 is located in the centrifugal separation space S as the upper layer, and the platelet-rich plasma layer P1 is located in the first space S1 as the lower layer.

[0196] In this state, similar to the first embodiment, if the first cylindrical outer shell is rotated relative to the first connecting hole 125 by means of the first insertion rod, the second separation is performed by isolating the platelet-rich plasma layer P1, which is the object to be separated, in such a way that only the platelet-rich plasma layer P1, which is the object to be separated, remains in the first space S1.

[0197] The platelet-rich plasma layer P1, which is the final object of centrifugation, is extracted and recovered from the outside using the injection needle of another syringe inserted through the elastic body 115 of the first sealing cap 110. This completes the centrifugation of the body fluid.

[0198] Those skilled in the art will understand that the present invention described above is not limited to the embodiments and drawings described above, and various substitutions, modifications and alterations can be made without departing from the technical concept of the present invention.

Claims

1. A bodily fluid separation device, characterized by, include: The first sealing cap has an elastic body at the center of the main body; The first cylindrical outer shell has one end threadedly connected to the first sealing cap, and an internal partition is provided inside the main body to form a first connecting hole, thereby forming a first space between it and the first sealing cap. The central cylindrical outer shell is threaded at one end to the other end of the first cylindrical outer shell in a manner that allows it to move with the first cylindrical outer shell. A central partition with at least one through hole is provided inside the main body for filling with body fluid. The second cylindrical outer shell has one end threadedly connected to the other end of the central cylindrical outer shell in a manner that allows for mutual threaded movement, and a second connecting hole is provided inside the main body. A second sealing cap is threaded to the other end of the second cylindrical outer shell to form a second space between it and the second cylindrical outer shell; and The control unit includes a first stop rod and a second stop rod. The first stop rod has a detachable end assembled to one end of a fixing hole formed in the stop frame portion of the central partition. A free end extending a predetermined length toward the first connecting hole is used to open and close the first connecting hole. The second stop rod has a detachable end assembled to the other end of a fixing hole formed in the stop frame portion of the central partition. A free end extending toward the second connecting hole is used to open and close the second connecting hole. The first stop rods selectively connect or block the internal spaces of the first space and the central cylindrical shell, and the second stop rods selectively connect or block the internal spaces of the second space and the central cylindrical shell. The first and second stop rods include: The first insertion rod and the second insertion rod each have one end inserted into the first connection hole and the second connection hole respectively; The first fixing rod and the second fixing rod are respectively inserted into the fixing holes formed in the stop frame portion of the aforementioned central partition to overlap each other; and The annular first and second protrusions are formed in the boundary region between the first and second insert rods and the first and second fixing rods, and are engaged by contacting the fixing holes of the stop bracket portion. The aforementioned first and second fixing rods each include a pair of facing planar portions formed by cutting a portion of the main body. These planar portions overlap to correspond to the fixing holes in the aforementioned stop bracket portion and are shaped on the same end face as the fixing holes. One side planar portion includes multiple locking portions protruding at predetermined intervals, and the remaining other side planar portion includes multiple locking portions that generate a locking force by locking with the aforementioned locking portions, wherein... The first fixing rod and the second fixing rod adjust the insertion depth in the fixing hole by changing the locking position between the locking part and the locked part, thereby extending or restoring the total length of the first stop rod and the second stop rod to its original state.

2. The bodily fluid separation device of claim 1, wherein, A press-in body is provided in a way that makes it difficult to detach from the outside through a through-hole formed on the outer surface of one of the first cylindrical shell, the second cylindrical shell, and the central cylindrical shell. Thus, before centrifugation, the injection needle of the syringe that has collected the body fluid is injected into the centrifugation space formed by the first stop bar and the second stop bar blocking the first connecting hole and the second connecting hole through the press-in body.

3. The bodily fluid separation device of claim 2, wherein, The outer surface of the housing used to form the through opening includes a cover member that forms an exposure hole to be fixed to the outer surface of the housing, so as to cover and fix the end of the press-in body while exposing a portion of the end face of the press-in body to the outside.

4. The bodily fluid separation device of claim 1, wherein, The aforementioned second sealing cap includes: The second outer skirt is threadedly connected to the other end of the aforementioned second cylindrical outer shell; The second inner skirt extends toward the second cylindrical outer shell at a predetermined interval from the second outer skirt, forming an annular groove for the other open end of the second cylindrical outer shell to enter; and An integral baffle closes the open end of the second inner skirt and enters the interior of the second cylindrical outer shell.

5. The bodily fluid separation device of claim 1, wherein, The aforementioned second sealing cap includes: The second outer skirt is threadedly connected to the other end of the aforementioned second cylindrical outer shell; The second inner skirt extends toward the second cylindrical outer shell at a predetermined interval from the second outer skirt, forming an annular groove for the other open end of the second cylindrical outer shell to enter; and A movable baffle is threadedly engaged in such a way that it can move along the inner surface of the second inner skirt, closing the open end of the second inner skirt and entering the interior of the second cylindrical shell.

6. The body fluid separation device according to claim 5, characterized in that, An auxiliary baffle is assembled in the second inner skirt in such a way that it contacts the movable baffle by means of a sealing O-ring component.

7. The body fluid separation device according to any one of claims 1 to 6, characterized in that, include: At least one configuration portion is recessed to a predetermined depth on the outer surface of one of the aforementioned first cylindrical outer shell, second cylindrical outer shell, and central cylindrical outer shell; and The working body is assembled into the aforementioned configuration section to form a communication port on the bottom surface of the aforementioned configuration section that connects to the internal space of the aforementioned outer casing. After centrifugal separation, the centrifugal separation space formed by the first stop bar and the second stop bar blocking the first connection hole and the second connection hole is converted from a vacuum atmosphere to an atmospheric pressure state.

8. The body fluid separation device according to claim 7, characterized in that, The aforementioned working body includes: A threaded body, having a specified length, is threadedly engaged with the aforementioned configuration part; and A cone is provided at the front end of the threaded body to transmit external force to the bottom surface of the configuration part to form the communication port.

9. The body fluid separation device according to claim 7, characterized in that, The aforementioned working body includes: A threaded body, having a specified length, is threadedly engaged with the aforementioned configuration part; and A cone is provided at the front end of the threaded body to selectively open or close the communication port by contacting or separating it from the communication port pre-formed on the bottom surface of the configuration part.

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