Body fluid component separation device

Abstract

A body fluid component separation device according to one embodiment may include: a housing; a piston that divides the housing into a first space and a second space and fluidly connects the first space and the second space; and a manipulator operatively coupled to the piston and configured to maintain pressure balance between the first space and the second space, while adjusting the movement of the piston between a first position having a first volume in the first space and a second position having a second volume in the first space different from the first volume, and for fixing the piston at any position between the first position and the second position.

Description

Technical Field

[0001] The following embodiments relate to a body fluid component separation device. Background Technology

[0002] Human body fluids (such as blood and bone marrow) contain various active components and cells. Plasma, a neutral yellow liquid obtained by separating and removing red blood cells from the blood, is a component of the blood. Platelet-rich plasma (PRP), obtained by centrifuging plasma, has multiple functions, including glue-like properties, coagulation and hemostasis, scaffolding for stem cell and primary cell migration and differentiation, angiogenesis regulation, anti-inflammatory effects, antibacterial effects, and analgesic effects. In particular, because PRP is associated with tissue regeneration, such as promoting cell proliferation, differentiation, and angiogenesis in tendons, ligaments, cartilage, and muscles, its clinical application in musculoskeletal injuries has attracted considerable attention. For example, Korean Patent Publication No. 10-2019-0059019 discloses a device for centrifuging blood components. Summary of the Invention

[0003] Technical problems to be solved

[0004] The purpose of one embodiment is to provide a body fluid component separation device that can move a piston downward while maintaining pressure balance between the upper space and the lower space of the piston, without considering external forces that cause the piston to move downward, such that when the piston descends, the pressure in the lower space of the piston increases and the pressure in the upper space of the piston decreases.

[0005] According to one embodiment, the aim is to provide a body fluid component separation device that sets the piston to be fixed by adjusting the initial position of the piston according to its capacity, thereby allowing the target body fluid to be separated to have an arbitrary capacity.

[0006] Technical methods for solving problems

[0007] A body fluid component separation device according to one embodiment may include: a housing; a piston that divides the housing into a first space and a second space and fluidly connects the first space and the second space; and a manipulator operatively coupled to the piston and configured to maintain pressure balance between the first space and the second space, while adjusting the movement of the piston between a first position having a first volume in the first space and a second position having a second volume in the first space different from the first volume, and for fixing the piston at any position between the first position and the second position.

[0008] The robotic arm may include: a shaft having a longitudinal axis; a male engagement element formed on the shaft; and a female engagement element that engages with the male engagement element and is fixedly mounted to the piston.

[0009] The robotic arm may include: a handle that includes a first engaging member; and a second engaging member that is connected to the shaft and engages with the first engaging member.

[0010] The device may also include an indicator configured to fluidly connect the first space and the second space and indicate a layer comprising a target material flowing from the first space to the second space.

[0011] The indicator may include: a tube including an inlet, an outlet, and a main channel defined between the inlet and the outlet; and an insert disposed inside the tube and on the main channel, and together with the tube defining a sub-channel, wherein the cross-section of the sub-channel is smaller than the cross-section of the main channel.

[0012] The insert may include a guide portion for guiding fluid flowing through the main channel to the sub-channel.

[0013] The device may further include a filter structure that fluidly connects the first space and the second space and filters the fluid flowing from the first space to the second space.

[0014] The filter structure may include: a filter housing having an inlet fluidly connected to the first space, a first outlet fluidly connected to the second space, and a second outlet fluidly connected to the second space and disposed opposite the first outlet; a first filter installed at the first outlet; and a second filter installed at the second outlet.

[0015] The filter structure includes a tube, wherein the tube includes a first end fluidly connected to the first space, a second end fluidly connected to an inlet of the filter housing, and a longitudinal portion extending between the first end and the second end, and the second end of the tube may protrude from the inner wall of the filter housing into the interior of the filter housing.

[0016] The piston may include: an outer body that moves along the housing; an inner body located inside the outer body; a partition that connects an end of the outer body and an end of the inner body and divides the interior of the housing into a first space and a second space; and a fluid channel that extends between the outer body and the inner body and extends from the partition, and fluidly connects the first space and the second space.

[0017] The partition may include a groove for accommodating the target material.

[0018] A piston for a body fluid component separation device according to one embodiment may include: an outer body; an inner body located inside the outer body and defining an internal space together with the outer body; a partition connecting the outer body and the inner body and separating the exterior of the outer body and the internal space; and a fluid channel extending in the internal space and extending from the partition, and fluidly connecting the internal space and the exterior of the outer body.

[0019] The effects of the invention

[0020] According to one embodiment of the body fluid component separation device, a piston can be moved downward while maintaining pressure balance between the upper space and the lower space of the piston, without considering external forces that cause the piston to move downward, such that when the piston descends, the pressure in the lower space of the piston increases and the pressure in the upper space of the piston decreases.

[0021] According to one embodiment of the body fluid component separation device, the piston can be fixed by adjusting the initial position of the piston according to its capacity, thereby allowing the target body fluid to be separated to have an arbitrary volume.

[0022] The effects of the body fluid component separation device according to one embodiment are not limited to those mentioned above. Other effects not mentioned will be understood by those skilled in the art through the following description. Attached Figure Description

[0023] Figure 1 This is a perspective view of the body fluid component separation device according to the first embodiment.

[0024] Figure 2 This is an exploded perspective view of the body fluid component separation device according to the first embodiment.

[0025] Figure 3 For observation from line AA Figure 1 A cross-sectional view of a body fluid component separation device.

[0026] Figure 4 For observation from the BB line Figure 3 A cross-sectional view of a body fluid component separation device.

[0027] Figure 5 for Figure 3 An enlarged view of the indicator of the body fluid component separation device.

[0028] Figures 6 to 10 This is an operational diagram of the body fluid component separation device according to the first embodiment.

[0029] Figure 11This is a perspective view of the body fluid component separation device according to the second embodiment.

[0030] Figure 12 This is an exploded perspective view of the body fluid component separation device according to the second embodiment.

[0031] Figure 13 For observation from the CC line Figure 11 A cross-sectional view of a body fluid component separation device.

[0032] Figure 14 It is observed from the DD line. Figure 11 A cross-sectional view of a body fluid component separation device.

[0033] Figure 15 for Figure 12 An exploded perspective view of the filter structure of a body fluid component separation device.

[0034] Figure 16 for Figure 14 A cross-sectional view of the filter structure of a body fluid component separation device.

[0035] Figures 17 to 20 This is an operational diagram of the body fluid component separation device according to the second embodiment.

[0036] Figure 21 This is a perspective view of a body fluid component separation device according to a third embodiment.

[0037] Figure 22 This is an exploded perspective view of the body fluid component separation device according to the third embodiment.

[0038] Figure 23 For observation from the EE line Figure 21 A cross-sectional view of a body fluid component separation device. Detailed Implementation

[0039] Hereinafter, embodiments will be described in detail with reference to the accompanying drawings. However, various modifications can be made to the embodiments, and the scope of the present invention is not limited or restricted by the embodiments. All variations, equivalents, or substitutions of the embodiments are included within the scope of the claims.

[0040] The terminology used in these embodiments is for illustrative purposes only and is not intended to limit the scope of the embodiments. Unless otherwise specified in the text, singular expressions include plural meanings. In this specification, terms such as "comprising" or "having" are used to indicate the presence of the features, numbers, steps, operations, constituent elements, accessories, or combinations thereof described in the specification, and do not exclude the presence of one or more other features, numbers, steps, operations, constituent elements, accessories, or combinations thereof, or additional functions.

[0041] Unless otherwise defined, all terms used herein, including technical or scientific terms, shall have the ordinary meaning as understood by one of ordinary skill in the art. Terms that are commonly used and are identical to their dictionary definitions shall be understood to have a meaning consistent with the general content of the relevant art, and shall not be overly idealized or interpreted as having a formal meaning unless expressly stated in this application.

[0042] Furthermore, in the description with reference to the accompanying drawings, identical constituent elements are assigned the same reference numerals, regardless of the drawing references, and repeated descriptions of these elements are omitted. In describing embodiments, detailed descriptions of relevant well-known technologies are omitted when it is determined that such detailed descriptions would unnecessarily obscure the embodiments.

[0043] Furthermore, in the description of the components of the embodiments, terms such as first, second, A, B, (a), (B) may be used. These terms are used only to distinguish one constituent element from another, and the nature, sequence, or order of the elements is not limited by these terms. When a constituent element is described as "connected," "bonded," or "in contact" with another constituent element, it should be understood that the constituent element can be directly connected to or attached to the other constituent element, or that the other constituent element is "connected," "bonded," or "in contact" with each constituent element.

[0044] Elements included in one embodiment and elements having common functions may be described using the same names in another embodiment. Unless otherwise stated, the description of one embodiment may be applied to other embodiments, and detailed descriptions will be omitted to the extent of repetition.

[0045] Reference Figures 1 to 5 According to one embodiment, the body fluid component separation device 10 can separate platelet-rich plasma (PRP) and bone marrow cell concentrate (BMC), which are the target materials, from the target body fluid to be separated. For example, the body fluid component separation device 10 can use centrifugation to separate the fluid into multiple layers, and can extract PRP and BMC from the pale yellow coating in the multiple layers. The body fluid component separation device 10 may include a housing 110, a piston 120, a robotic arm 130, and an indicator 140.

[0046] The housing 110 may accommodate at least a portion of the piston 120, the robotic arm 130, and the indicator 140. The housing 110 may include a container 111 and a lid 112. The container 111 and the lid 112 may define a sealed space immediately adjacent to the outside.

[0047] Container 111 may be elongated cylindrical. Furthermore, container 111 may have an open upper end, closed sides, and a lower end. The open upper end of container 111 may have a stepped difference 111E that is radially recessed along container 111.

[0048] Container 111 may be formed of a substantially transparent or substantially translucent material so that the interior of container 111 can be seen from the outside. The user can confirm the amount of the target bodily fluid to be separated inside container 111, the movement of the multilayer material obtained by separating the bodily fluid, etc.

[0049] The lid 112 can seal the open upper end of the container 111. The lid 112 may include a sealing plate 113, a first plug 114A, a second plug 114B, a one-way valve 115, a sealing cap 116A, a sealing ring 116B, and a piston guide 117.

[0050] The sealing plate 113 can cover the open upper end of the container 111. The sealing plate 113 can have a substantially disc-shaped form. The sealing plate 113 can be connected from the open upper end of the container 111 to the step difference 111E of the container 111.

[0051] The sealing plate 113 may include a first stopper 114A and a second stopper 114B in fluid communication. In one example, the target bodily fluid to be separated can be contained in the container 111 through the first stopper 114A and the first opening O1. In another example, a portion of the material contained in the container 111 can be removed from the container 111 through the first stopper 114A and the first opening O1. Furthermore, the target material contained in the second space S2 can be extracted through the second stopper 114B. The first opening O1 may be formed in the central portion of the sealing plate 113, and the second opening O2 may be formed in the peripheral portion of the sealing plate 113.

[0052] The sealing plate 113 may include a first annular protrusion P1 formed around the first opening O1 and projecting outward from the container 111, and a first needle coupling portion C1 formed around the first opening O1 and projecting inward from the container 111. Furthermore, the sealing plate 113 may include a second protrusion P2 formed around the second opening O2 and projecting outward from the container 111, and a second needle coupling portion C2 formed around the second opening O2 and projecting inward from the container 111. The first needle N1 may be configured to inject the target fluid to be separated into the container 111 and may be coupled to the first needle coupling portion C1. Additionally, the first needle N1 may be used to remove a portion of the material included in the container 111 from the container 111. The second needle N2 may be configured to extract the target material included in the second space S2 and may be coupled to the second needle coupling portion C2.

[0053] The first plug 114A can open and close the first opening O1. The first plug 114A may include a first thread 114A-1, which can be coupled to an external unit (such as a syringe) at one end, and can accommodate a first sealing member 114A-2. The first sealing member 114A-2 can substantially open and close the first opening O1. The first plug 114A can be detachably coupled to a first annular protrusion P1.

[0054] The second plug 114B can open and close the second opening O2. The second plug 114B may include a second thread 114B-1, which can be coupled to an external unit (such as a syringe) at one end, and can accommodate a second sealing member 114B-2. The second plug 114B can be detachably coupled to a second annular protrusion P2.

[0055] The first sealing member 114A-2 and / or the second sealing member 114B-2 may be formed of a soft material such as silicone. Therefore, when the first plug 114A and / or the second plug 114B are coupled to the external unit, the first sealing member 114A-2 and / or the second sealing member 114B-2 may deform, and the first opening O1 and / or the second opening O2 may open. Additionally, when the first plug 114A and / or the second plug 114B are separated from the external unit, the deformed first sealing member 114A-2 and / or the second sealing member 114B-2 can return to their original shape, and the first opening O1 and / or the second opening O2 can close again.

[0056] The one-way valve 115 can prevent fluid (e.g., air) from flowing into the interior of the container 111 from the outside of the container 111, but can allow fluid contained in the container 111 to flow out of the container 111. The one-way valve 115 can be located on the outer periphery of the sealing plate 113.

[0057] The sealing cap 116A and sealing ring 116B can seal the coupling portion between the sealing plate 113 and the adjustment portion 136 of the robot 130 (described later). The sealing plate 113 may include a third annular protrusion P3 that surrounds a portion of the shaft 1361 of the adjustment portion 136 and protrudes outward from the container 111, and the sealing cap 116A and sealing ring 116B can be inserted between the third annular protrusion P3 and the shaft 1361.

[0058] The piston guide 117 can guide the movement of the piston 120. The piston guide 117 can extend from the position of the sealing plate 113 with the third annular protrusion P3 into the interior of the container 111.

[0059] The piston 120 can be housed in the container 111 and can move longitudinally along the inner surface of the container 111. The piston 120 may include an outer body 121, an inner body 122, a partition 123, a fluid passage 124, and a piston seal ring 125.

[0060] The inner body 122 can be disposed inside the outer body 121. Each of the outer body 121 and the inner body 122 can be cylindrical. Therefore, an annular space can be substantially defined between the outer body 121 and the inner body 122. The second space S2 can include the annular space defined by the outer body 121 and the inner body 122 as described above. The piston guide 117 can be disposed in the annular space between the outer body 121 and the inner body 122. At least a portion of the outer side of the inner body 122 can substantially contact the piston guide 117. When the piston 120 moves longitudinally along the container 111, the inner body 122 of the piston 120 can move along the piston guide 117.

[0061] The internal body 122 may include a first longitudinal portion 1221 having a first diameter, and a second longitudinal portion 1222 connected to the first longitudinal portion 1221 and having a second diameter. The first diameter of the first longitudinal portion 1221 may be smaller than the second diameter of the second longitudinal portion 1222. Therefore, a step difference may be formed between the first longitudinal portion 1221 and the second longitudinal portion 1222.

[0062] The partition 123 can connect the outer body 121 and the inner body 122, and can divide the sealed space of the outer shell 110 defined by the container 111 and the lid 112 into a first space S1 and a second space S2. For example, the first space S1 can refer to the lower space of the container 111 separated by the partition 123, while the second space S2 can refer to the upper space of the container 111 and the interior of the piston 120 separated by the partition 123. The partition 123 can connect the lower end of the outer body 121 and the lower end of the inner body 122. Furthermore, the partition 123 can have a truncated cone shape, with its diameter decreasing from the outer side to the inner side.

[0063] The partition 123 may include a groove 1231 for accommodating at least one material in the second space S2. Here, the groove 1231 may be formed at the lowest position of the partition 123, which is formed to be substantially inclined, and may have a shape in which the width narrows in the thickness direction of the partition 123.

[0064] The partition 123 may include a sealing groove 1232 formed radially in the piston 120. The piston seal ring 125 may be coupled to the sealing groove 1232 to maintain a seal between the piston 120 and the container 111.

[0065] The fluid channel 124 can fluidly connect the first space S1 and the second space S2. Since the partition 123 divides the sealed space of the housing 110 into the first space S1 and the second space S2, the first space S1 and the second space S2 can be fluidly connected through the fluid channel 124. The fluid channel 124 can extend between the outer body 121 and the inner body 122, and also extend from the partition 123. The extension length of the fluid channel 124 can be less than the length of the outer body 121 and the length of the inner body 122. Additionally, the fluid channel 124 can accommodate a first needle N1. The first needle N1 can fluidly connect the first opening O1 and the first space S1 through the fluid channel 124.

[0066] Furthermore, the partition 123 connects the outer body 121 and the inner body 122 to the fluid passage 124. For example, when the piston 120 is viewed in a first radial direction, the partition 123 may have a shape that converges from the lower end of the outer body 121 to the lower end of the fluid passage 124; when the piston 120 is viewed in a second radial direction intersecting the first radial direction, the partition 123 may have a shape that diverges from the lower end of the fluid passage 124 to the lower end of the outer body 121. In other words, the partition 123 may have a substantially inclined upper portion (which connects the outer body 121 and the inner body 122 to the fluid passage 124) and a substantially inclined lower portion (which extends from the end of the fluid passage 124 and moves away from the upper portion), and a gap G may be formed between the upper and lower portions.

[0067] The manipulator 130 can move the piston 120 relative to the housing 110. The manipulator 130 can be operatively coupled to the piston 120. Here, "operatively coupled" can indicate that the manipulator 130 directly drives the piston 120. Preferably, the manipulator 130 can move the piston 120 while maintaining the piston 120 in a substantially stable state. This can mean maintaining an external seal relative to the first space S1 and the second space S2 separated by the piston 120, and maintaining a balance of pressure between the first space S1 and the second space S2. Furthermore, when the manipulator 130 is not operated by the male engagement element 1362 and the female engagement element 1363, the manipulator 130 can fix the position of the piston 120 relative to the housing 110. Therefore, even if external forces such as centrifugal force or vibration are applied to the body fluid component separation device 10, the piston 120 can be fixed in place, and the volume ratio of the first space S1 and the second space S2 can be accurately determined according to the volume of the target body fluid included in the housing 110.

[0068] The robotic arm 130 may include a handle 131, a pair of engaging members 134A and 134B, and an adjustment part 136.

[0069] The handle 131 can be configured to be operated by a user. Here, the handle 131 can be operated by a mechanical and / or electrical mechanism as well as by a person. The handle 131 may have a bottom surface and side surfaces 135A defining an inner space 132, and may have a substantially cylindrical shape. A plurality of recesses 135B may be formed on the side surfaces 135A of the handle 131 along the circumferential direction of the handle 131. Furthermore, the handle 131 may include a hollow protrusion 133 projecting from the bottom surface defining the inner space 132. The hollow protrusion 133 may accommodate a first plug 114A.

[0070] The handle 131 can be rotatably coupled to the housing 110. In addition, the handle 131 can be detachably coupled to the housing 110.

[0071] A pair of engaging members 134A, 134B may include a first engaging member 134A formed around a hollow protrusion 133 and a second engaging member 134B operably connected to an adjusting portion 136. The first engaging member 134A and the second engaging member 134B may be operably engaged with each other. When the user rotates the handle 131 during use, the first engaging member 134A rotates accordingly, and the second engaging member 134B, which is engaged with the first engaging member 134A, also rotates together, thereby operating the adjusting portion 136. In one example, the pair of engaging members 134A, 134B may include a spur gear.

[0072] The adjusting part 136 can finely adjust the movement of the piston 120. Furthermore, the adjusting part 136 can fix the piston 120 in place. The adjusting part 136 may include a shaft 1361, a male engagement element 1362, and a female engagement element 1363.

[0073] Shaft 1361 may have a longitudinal axis and be rotatable about the longitudinal axis. Shaft 1361 may include a head 1365 mounted on sealing plate 113 and a coupling portion 1366 coupled to the second engaging member 134B. The head 1365 may be placed on the top surface of sealing plate 113, and sealing cap 116A and sealing ring 116B may be inserted above the head 1365 and between shaft 1361 and third annular protrusion P3. The coupling portion 1366, as the portion located above the head 1365 and above sealing cap 116A, may define the upper end of shaft 1361.

[0074] A male engagement element 1362 may be formed longitudinally along the shaft 1361 and may have a predetermined pitch. The male engagement element 1362 may be helically formed within a portion of the shaft 1361 below the sealing plate 113. The shaft 1361 and the male engagement element 1362 can be understood as forming a rigid screw structure. A female engagement element 1363 may engage with the male engagement element 1362 and may have a pitch corresponding to the pitch of the male engagement element 1362. The female engagement element 1363 can be understood as forming a nut structure. The pitches of the male engagement element 1362 and the female engagement element 1363 can be determined based on the rotation angle of the user's handle 131 and the travel distance of the piston 120. Furthermore, if the pitch is extremely high, the piston 120 can move when the shaft 1361 rotates due to the force applied to the piston by an external force (e.g., centrifugal force). Therefore, the pitch can be determined within an appropriate range to prevent the shaft 1361 from being rotated by an external force while minimizing the operation of the handle 131.

[0075] Simultaneously, the female engagement element 1363 can be accommodated and installed in the cavity of the second longitudinal portion 1222 of the piston 120. Therefore, the female engagement element 1363 can move together with the piston 120. For example, the female engagement element 1363 may include a protrusion 1364 that can be rigidly fixed to the inner body 122 of the piston 120. Furthermore, the female engagement element 1363 can be limited by the step difference between the first longitudinal portion 1221 and the second longitudinal portion 1222.

[0076] As described above, the engagement of the male engagement element 1362 and the female engagement element 1363 allows the user to fix the piston 120 in the desired position while ensuring that the piston 120 moves in a stable state.

[0077] Indicator 140 can be configured to indicate a predetermined fluid flowing between the first space S1 and the second space S2. Indicator 140 “indicating fluid” can be understood as: displaying to the user the amount and flow rate of a pale yellow coating containing platelet-rich plasma in multiple layers obtained by separating the target fluid through a predetermined process.

[0078] Typically, the target fluid to be separated can be divided into multiple layers through a series of processes (e.g., centrifugation). Because the buffy coat in these layers contains relatively little platelet-rich plasma compared to other components, it can be very thin. Therefore, users may need to be very careful when extracting the platelet-rich plasma contained within the buffy coat, and during extraction, they may accidentally mix the buffy coat with other layers through manipulation. Therefore, it is necessary to more clearly display the buffy coat to the user to prevent mixing of the buffy coat through user manipulation.

[0079] The indicator 140 may include a tube 141 and an insert 143.

[0080] The tube 141 may have an inlet in fluid communication with the fluid passage 124 and an outlet in fluid communication with the second space S2. A main flow channel CH1 through which fluid can flow may be defined inside the tube 141. In addition, the tube 141 may include a thin plate 142 formed in the outlet.

[0081] Insert 143 may be disposed inside tube 141. Here, the term "insert" can be understood not only as being inserted into tube 141 in a predetermined direction, but also as being disposed only inside tube 141. Insert 143 may have a tubular shape, and the first needle N1 may pass through the interior of insert 143. Furthermore, insert 143 may include a radial extension 144 connected to sheet 142.

[0082] Insert 143 can be arranged on the main channel CH1 to form a sub-channel CH2 with pipe 141, having a smaller flow area than the main channel CH1. Therefore, when fluid flowing through the main channel CH1 at a predetermined flow rate enters the sub-channel CH2, the flow length of the fluid in the sub-channel CH2 may be significantly increased compared to the main channel CH1. For example, since the pale yellow coating containing significantly less platelet-rich plasma in the target fluid to be separated has a longer flow length in the sub-channel CH2 than in the main channel CH1, the user can accurately analyze the extent and presence of the pale yellow coating.

[0083] The insert 143 may include a hollow portion for accommodating the first needle N1. The first needle N1 may pass through the hollow portion of the insert 143 and penetrate the insert 143, and after passing through the insert 143, it may sequentially enter the fluid channel 124 and the first space S1.

[0084] Insert 143 may include a guide portion 145 to smoothly guide fluid from the main channel CH1 to the sub-channel CH2. The guide portion 145 may be formed in the end of insert 143 at the upstream portion of the sub-channel CH2. The guide portion 145 may have a tapered shape, with its width varying towards the end of insert 143. For example, the guide portion 145 may narrow longitudinally towards the end of insert 143.

[0085] Below, we will refer to Figures 6 to 10 The operation of a body fluid component separation device 10 according to one embodiment is described. (Not shown) Figures 6 to 10 Components in can be found in Figures 1 to 5 To understand clearly.

[0086] Reference Figure 6With the handle 131 removed, the user can couple the first stopper 114A to an external unit (e.g., a syringe) to inject blood BF or bone marrow, which is the target body fluid for separation, into the first space S1 of the container 111 under the piston 120 via the first needle N1. Subsequently, the user can lower the piston 120 according to the volume of blood BF or bone marrow to position and fix the piston 120 so that the piston sealing ring 125 can be close to the blood BF or bone marrow.

[0087] Subsequently, when centrifugation is performed using the body fluid component separation device 10 while the handle 131 is coupled, the blood BF or bone marrow can be separated into a layer comprising a first material M1, a layer comprising a second material M2, and a layer comprising a third material M3, based on specific gravity, and these layers can be formed from the bottom of the container 111. For example, the first material M1 may include red blood cells, the second material M2 may include platelet-rich plasma (PRP) and bone marrow cell concentrate, and the third material M3 may include platelet-poor plasma, fat, or oil. Specifically, the thickness of the layer comprising the second material M2 may be much smaller than the thickness of the layer comprising the first material M1 and the layer comprising the third material M3.

[0088] Reference Figure 7 If the user holds and rotates the handle 131, the first engaging member 134A can rotate with the handle 131, and the second engaging member 134A, which engages with the first engaging member 134A, can also rotate. Furthermore, the shaft 1361 connected to the second engaging member 134B can rotate and engage with the male engaging element 1362 formed in the shaft 1361, allowing the male engaging element 1362 to move at a predetermined pitch. Consequently, the piston 120, on which the female engaging element 1363 is mounted, can descend by a predetermined pitch together with the female engaging element 1363. As the piston 120 descends, the volume of the first space S1 decreases, while the volume of the second space S2 increases to a corresponding size. As a result, the first space S1 and the second space S2 can achieve pressure equilibrium. At this time, the third material M3 can move along the partition 123 and flow through the fluid channel 124 and the main channel CH1 and sub-channel CH2 of the indicator 140, thereby filling the second space S2. The second material M2 can move along the partition 123 and flow into the fluid channel 124, so that the fluid channel 124 can be filled to a predetermined height.

[0089] Subsequently, the user can remove the handle 131 and extract the second material M2 from the container 111 via the first needle N1 by coupling the extraction device to the first stopper 114A. For example, the extraction device may include various mechanisms for extracting other materials, such as a syringe with a first thread 114A-1 that can be coupled to the first stopper 114A, and a pressure unit that applies pressure from the front to the rear of the syringe. Through this process, the first material M1 can remain substantially in the first space S1, and a small amount of the second material M2 that is not extracted by the extraction device described above may exist.

[0090] In order to concentrate the second material M2 and minimize the loss of the second material M2, the second material M2 can preferably be extracted in the following manner, rather than in the manner described above.

[0091] Reference Figure 8 If the user holds and rotates the handle 131, power can be transmitted to the first engaging member 134A, the second engaging member 134B, the shaft 1361, the male engaging member 1362, the female engaging member 1363, and the piston 120, and the piston 120 can continue to descend. Therefore, the second material M2 and the first material M1 in the first space S1 can be further forced into the second space S2 through the fluid channel 124. In particular, when a very small amount of the second material M2 flows through the main channel CH1 of the pipe 141 and enters the sub-channel CH2 defined by the pipe 141 and the insert 143, the layer including the second material M2 can diffuse along the sub-channel CH2 between the pipe 141 and the insert 143. Therefore, it can be understood that because the flow area of ​​the sub-channel CH2 is smaller than the flow area of ​​the main channel CH1, the flow length of the second material M2 flowing through the sub-channel CH2 is greater than the flow length of the second material M2 flowing through the main channel CH1. Based on the above scheme, users can intuitively and easily determine whether the second material M2 exists in the sub-channel CH2 and the amount of the second material M2, thereby more clearly identifying the boundary between the second material M2 and the first material M1.

[0092] Reference Figure 9The user can also rotate handle 131 to further lower piston 120. If piston 120 is fully lowered, the second material M2, in addition to the third material M3, can enter the second space S2 through the outlet of tube 141. The second material M2 and the third material M3 entering the second space S2 can be accommodated in the groove 1231 and the second space S2 along the partition 123. At this time, the second material M2 and the third material M3 can be kept mixed in the groove 1231 and the second space S2. When monitoring the flow of the second material M2 and the first material M1 through the sub-channel CH2 of indicator 140, the user can stop piston 120 at the position where the first material M1 does not enter the second space S2 through the outlet of tube 141 to prevent the first material M1 from flowing into the second space S2 through the outlet of tube 141, and can raise piston 120 by rotating handle 131 in the opposite direction to allow the second needle N2 to fully extract the second material M2 (accommodating it in the groove 1231 by centrifugation). Subsequently, the user can perform additional centrifugation on the body fluid component separation device 10. As a result, due to the difference in specific gravity, the layer including the second material M2 can be mainly formed in the groove 1231, and the layer including the third material M3 can be formed on the groove 1231.

[0093] Reference Figure 10 After additional centrifugation, the user can remove handle 131 (see [link]). Figure 3 ), and use the above reference. Figure 7 The extraction device extracts the second material M2 from the container 111 via the second needle N2. At this time, the user can extract the second material M2 and a portion of the third material M3 together if necessary, or extract the third material M3 by lowering the piston to the appropriate position and then extract the second material M2 by raising the piston 120.

[0094] Reference Figures 11 to 16 (Refer to the above text) Figures 1 to 10 Similar to the body fluid component separation device 10, the body fluid component separation device 20 according to one embodiment can separate platelet-rich plasma (PRP) and bone marrow cell concentrate (BMC), which are the target materials, from the target fluid to be separated. The body fluid component separation device 20 according to this embodiment may include a filter structure 240, instead of referring to... Figures 1 to 10 The indicator 140 of the body fluid component separation device 10 is described. Therefore, unless otherwise stated, the body fluid component separation device 20 according to one embodiment is described based on the assumption that components and their sub-components having the same reference numerals have the same structure, function, effect, etc.

[0095] The filter structure 240 can be fluidly connected to the first space S1 and the second space S2 of the container 111 separated by the piston 120, and can filter a portion of the material in the fluid flowing from the first space S1 to the second space S2.

[0096] The filter structure 240 may include a filter housing 241, a first filter F1, a second filter F2, a tube 242, a filter cover 243, a sealing cover 244A, and a sealing ring 244B.

[0097] The filter housing 241 can form a space where fluid flowing from the first space S1 to the second space S2 resides. For example, the filter housing 241 may include an inlet IP in fluid communication with the first space S1, a pair of outlets OP1 and OP2 in fluid communication with the second space S2, and a residence space between the inlet IP and the pair of outlets OP1 and OP2. The pair of outlets OP1 and OP2 may be opposite each other relative to the flow direction. This can be understood as the fluid passing through the filter housing 241 being divided into a first path through the residence space from the inlet IP to the first outlet OP1 and a second path through the residence space from the inlet IP to the second outlet OP2.

[0098] The first filter F1 and the second filter F2 can filter fluid flowing from the residence space of the filter housing 241 to the second space S2. Furthermore, the first filter F1 can be installed in the first outlet OP1, and the second filter F2 can be installed in the second outlet OP2. The pore size of the first filter F1 and the second filter F2 is suitable for delivering platelet-rich plasma and bone marrow cell concentrate to the second space S2 and blocking red blood cells. For example, the first filter F1 and the second filter F2 can be mesh filters.

[0099] In the filter housing 241, the central portion of the filter housing 241 can accommodate the first needle N1, the first side 2411 of the filter housing 241 can surround the second needle N2, and the second side 2412 of the filter housing 241, opposite to the first side 2411, can surround the piston guide 117. For example, the filter housing 241 can be integrally cylindrical, the first side 2411 and the second side 2412 can have the shape of curved grooves, and the radius of curvature of the first side 2411 can be smaller than the radius of curvature of the second side 2412.

[0100] The tube 242 can fluidly connect the fluid passage 124 and the filter housing 241. For example, the tube 242 may include a first end 2421 connected to a downstream portion of the fluid passage 124, a second end 2422 leading to a dwell space in the filter housing 241 and connected to an inlet IP of the filter housing 241, and a longitudinal portion 2423 extending between the first end 2421 and the second end 2422. The first needle N1 may pass through the filter housing 241, the tube 242, and the fluid passage 124.

[0101] The second end 2422 of the tube 242 may protrude into the residence space of the filter housing 241. For example, the second end 2422 of the tube 242 may protrude from the inner wall of the filter housing 241. This may be advantageous because the user can see the target material (e.g., platelet-rich plasma) flowing through the tube 242 and into the residence space. Furthermore, the tube 242 may include a step difference 2424 formed between the second end 2422 of the tube 242 and the inner wall of the filter housing 241. The thickness of a portion of the step difference 2424 may vary in the direction from the inner wall of the filter housing 241 toward the second end 2422.

[0102] The filter cover 243 can accommodate the first filter F1. The cross-section of the filter cover 243 can have the same shape as the filter housing 241. The filter cover 243 can be detachably installed on the first outlet OP1 of the filter housing 241. In addition, the central portion of the filter cover 243 can accommodate the first needle N1.

[0103] The sealing cap 244A and the sealing ring 244B can seal the coupling part between the first needle N1 and the filter cover 243.

[0104] Below, we will refer to Figures 17 to 20 Describe the operation of the body fluid component separation device 20. Figures 17 to 20 Components not shown will be from Figure 5 and Figures 11 to 16 It is clearly understood. Figures 17 to 20 The operating methods not described in the text are the same as those mentioned above. Figures 6 to 10 The operation of the body fluid component separation device 10 described herein overlaps to some extent, therefore repeated descriptions will be omitted herein.

[0105] Reference Figure 17If the user lowers the piston 120 by operating the robotic arm 130, the third material M3, the second material M2, and the first material M1 can flow sequentially along the fluid channel 124. Specifically, the user can detect the point at which the second material M2 is about to enter the residence space of the filter housing 241 from the tube 242, remove the handle 131, and then use the same extraction device as described above to extract the second material M2 through the first needle N1. Additionally, any extra second material M2 not extracted through the first needle N1 can enter the residence space of the filter housing 241.

[0106] Reference Figure 18 A portion of the second material M2 and the third material M3 can mix in the residence space of the filter housing 241. If the piston continues to descend, a vacuum may be created in the second space S2, forcing the airflow from the residence space of the filter housing 241 to the second space S2. Here, the first filter F1 and the second filter F2 can allow the second material M2 and the third material M3 to flow, but prevent the first material M1 from flowing. Therefore, only the second material M2 and the third material M3 present in the residence space of the filter housing 241 can escape into the second space S2, while a portion of the remaining second material M2 and the third material M3 can be released during the subsequent centrifugation process.

[0107] Reference Figure 19 The second material M2 and the third material M3, which escape into the second space S2, can be contained in a mixed state in the groove 1231 of the partition 123 and the second space 2S. Subsequently, the user can centrifuge the body fluid component separation device 20. Therefore, due to the difference in specific gravity, the layer including the second material M2 can be mainly formed in the groove 1231, while the layer including the third material M3 can be formed thereon.

[0108] Reference Figure 20 The user can raise piston 120 to extract the second material M2. If piston 120 rises sufficiently to allow the second needle N2 to extract the second material M2 contained in groove 1231, the user can remove handle 131 (see...). Figure 3 Using the same extraction device as described above, the second material M2 is extracted from the container 111 through the second needle N2. At this time, the user can extract the second material M2 and a portion of the third material M3 together if necessary, or extract the third material M3 by raising the piston to the appropriate position and then extract the second material M2 by raising the piston 120.

[0109] Reference Figures 21 to 23 According to one embodiment, the body fluid component separation device 30 can separate platelet-rich plasma (PRP) and bone marrow cell concentrate (BMC), which are the target materials, from the target body fluid to be separated, similar to the above description. Figures 1 to 20The body fluid component separation devices 10 and 20 are described. The body fluid component separation device 30 of this embodiment may include a robotic arm 330 (whose structure differs from the reference device). Figures 1 to 20 The described structure includes the robotic arm 130 of the body fluid component separation devices 10 and 20, and the filter structure 340 (whose structure differs from the reference). Figures 11 to 20 The structure of the filter structure 240 of the body fluid component separation device 20 is described. Unless otherwise stated, the PRP separation device 30 according to one embodiment is described based on the assumption that components and their sub-components having the same reference numerals have the same structure, function, effect, etc.

[0110] The robotic arm 330 may include an adjustment unit 336 configured to finely adjust the movement of the piston 120 and hold the piston 120 in place. The adjustment unit 336 may include a shaft 3361 having a male engagement element 1362 formed thereon.

[0111] Shaft 3361 may have a tubular shape. Furthermore, the male engagement element 1362 may be formed only on a portion of shaft 3361 along its longitudinal direction. For example, the male engagement element 1362 may be formed only from the upper portion of shaft 3361 to the center portion of shaft 3361.

[0112] When viewed longitudinally along the shaft 3361, the shaft 3361 may include a first opening H1 at the upper first end and a second opening H2 at the lower second end. After the handle 131 is removed, the user can inject the target body fluid for separation through the first opening H1, and the injected target body fluid for separation can be contained in the first space S1 along the inner cavity of the shaft 3361 through the second opening H2.

[0113] Shaft 3361 can be arranged in the central part of container 111. At this time, piston guide 117 and inner body 122 can also be located in the central part of container 111, and fluid passage 124 can be located around piston guide 117.

[0114] Additionally, the piston 120 may include an additional sealing ring 126 between the shaft 3361 and the inner body 122. The sealing ring 126 may be accommodated in an internal recess of the inner body 122 to maintain a seal between the shaft 3361 and the inner body 122.

[0115] The filter structure 340 may include a filter housing 341 and a first filter F1. The filter housing 341 may be substantially bowl-shaped, and the end of the fluid channel 124 may penetrate the filter housing 341. The upper part of the filter housing 341 may communicate with the second space S2, while the lower part of the filter housing 341 may be fluidly connected to the second space S2 through the first filter F1. Therefore, the target material of the body fluid passing through the fluid channel 124 (e.g., platelet-rich plasma) can be contained in the filter housing 341 and flow into the second space S2 through the first filter F1 during centrifugation, and specific materials (e.g., red blood cells) can be contained in the filter housing 341 while remaining within the filter housing 341.

[0116] In summary, the embodiments have been described with reference to the limited accompanying drawings. Those skilled in the art can make various modifications and variations based on the description. For example, appropriate results can be obtained by performing the described techniques in a different order than the described methods, and / or by combining or integrating the described systems, structures, devices, circuits, and other constituent elements in a different manner than the described methods, or by replacing or substituting them with other constituent elements or equivalents.

[0117] Therefore, other embodiments, other implementations, and equivalents within the scope of the claims are all within the scope of the claims of this invention.

Claims

1. A body fluid component separation device, characterized in that, include: shell; A piston that divides the outer casing into a first space and a second space, and fluidly connects the first space and the second space; as well as A robotic arm, operably coupled to the piston and configured to adjust the movement of the piston between a first position having a first volume in the first space and a second position having a second volume different from the first volume while keeping the piston in a generally stable state, and to fix the piston relative to the housing at any position between the first position and the second position, such that the piston remains stationary at that arbitrary position. When the piston moves between the first position and the second position, the pressure balance between the first space and the second space is maintained.

2. The body fluid component separation device according to claim 1, characterized in that, The robotic arm includes: A shaft, which has a longitudinal axis; Male meshing element, which is formed on said shaft; and A female engagement element engages with the male engagement element and is fixedly mounted to the piston.

3. The body fluid component separation device according to claim 2, characterized in that, The robotic arm includes: A handle, comprising a first engaging member; and A second engaging member is connected to the shaft and engages with the first engaging member.

4. The body fluid component separation device according to claim 1, characterized in that, Also includes: An indicator is configured to fluidly connect the first space and the second space and indicate a layer of target material including the material flowing from the first space to the second space.

5. The body fluid component separation device according to claim 4, characterized in that, The indicator includes: The pipe includes an inlet, an outlet, and a main passage defined between the inlet and the outlet; and An insert is disposed inside the tube and on the main channel, and together with the tube defines a sub-channel, wherein the cross-section of the sub-channel is smaller than the cross-section of the main channel.

6. The body fluid component separation device according to claim 5, characterized in that, The insert includes a guide portion for guiding fluid flowing through the main channel to the sub-channel.

7. The body fluid component separation device according to claim 1, characterized in that, Also includes: A filter structure that fluidly connects the first space and the second space, and filters the fluid flowing from the first space to the second space.

8. The body fluid component separation device according to claim 7, characterized in that, The filter structure includes: The filter housing has an inlet fluidly connected to the first space, a first outlet fluidly connected to the second space, and a second outlet fluidly connected to the second space and disposed opposite the first outlet; A first filter, which is installed at the first outlet; and The second filter is installed at the second outlet.

9. The body fluid component separation device according to claim 8, characterized in that, The filter structure includes a tube, wherein the tube includes a first end fluidly connected to the first space, a second end fluidly connected to an inlet of the filter housing, and a longitudinal portion extending between the first end and the second end. The second end of the tube protrudes from the inner wall of the filter housing into the interior of the filter housing.

10. The body fluid component separation device according to claim 1, characterized in that, The piston includes: The outer body moves along the outer shell; An inner body, which is located inside the outer body; A partition connecting the end of the outer body and the end of the inner body, and dividing the interior of the outer shell into the first space and the second space; and A fluid channel extends between the outer body and the inner body and from the partition, and fluidly connects the first space and the second space.

11. The body fluid component separation device according to claim 10, characterized in that, The partition includes a groove for accommodating the target material.

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