WO2022068023A1 - 液体分离套件 - Google Patents

液体分离套件 Download PDF

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Publication number
WO2022068023A1
WO2022068023A1 PCT/CN2020/130737 CN2020130737W WO2022068023A1 WO 2022068023 A1 WO2022068023 A1 WO 2022068023A1 CN 2020130737 W CN2020130737 W CN 2020130737W WO 2022068023 A1 WO2022068023 A1 WO 2022068023A1
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Prior art keywords
chamber
liquid separation
free end
piston
separation kit
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PCT/CN2020/130737
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English (en)
French (fr)
Inventor
吴宜娜
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辅仁大学学校财团法人辅仁大学
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Application filed by 辅仁大学学校财团法人辅仁大学 filed Critical 辅仁大学学校财团法人辅仁大学
Priority to JP2022581681A priority Critical patent/JP7495157B2/ja
Priority to US18/013,816 priority patent/US20230285875A1/en
Priority to EP20956042.4A priority patent/EP4238626A1/en
Publication of WO2022068023A1 publication Critical patent/WO2022068023A1/zh

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/02—Blood transfusion apparatus
    • A61M1/029—Separating blood components present in distinct layers in a container, not otherwise provided for
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01D—SEPARATION
    • B01D17/00—Separation of liquids, not provided for elsewhere, e.g. by thermal diffusion
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B04—CENTRIFUGAL APPARATUS OR MACHINES FOR CARRYING-OUT PHYSICAL OR CHEMICAL PROCESSES
    • B04B—CENTRIFUGES
    • B04B5/00—Other centrifuges
    • B04B5/04—Radial chamber apparatus for separating predominantly liquid mixtures, e.g. butyrometers
    • B04B5/0407—Radial chamber apparatus for separating predominantly liquid mixtures, e.g. butyrometers for liquids contained in receptacles
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/05—Containers specially adapted for medical or pharmaceutical purposes for collecting, storing or administering blood, plasma or medical fluids ; Infusion or perfusion containers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14—Details; Accessories therefor
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L3/00—Containers or dishes for laboratory use, e.g. laboratory glassware; Droppers
    • B01L3/50—Containers for the purpose of retaining a material to be analysed, e.g. test tubes
    • B01L3/502—Containers for the purpose of retaining a material to be analysed, e.g. test tubes with fluid transport, e.g. in multi-compartment structures
    • B01L3/5027—Containers for the purpose of retaining a material to be analysed, e.g. test tubes with fluid transport, e.g. in multi-compartment structures by integrated microfluidic structures, i.e. dimensions of channels and chambers are such that surface tension forces are important, e.g. lab-on-a-chip
    • B01L3/50273—Containers for the purpose of retaining a material to be analysed, e.g. test tubes with fluid transport, e.g. in multi-compartment structures by integrated microfluidic structures, i.e. dimensions of channels and chambers are such that surface tension forces are important, e.g. lab-on-a-chip characterised by the means or forces applied to move the fluids
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B04—CENTRIFUGAL APPARATUS OR MACHINES FOR CARRYING-OUT PHYSICAL OR CHEMICAL PROCESSES
    • B04B—CENTRIFUGES
    • B04B7/00—Elements of centrifuges
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/483—Physical analysis of biological material
    • G01N33/487—Physical analysis of biological material of liquid biological material
    • G01N33/49—Blood
    • G01N33/491—Blood by separating the blood components
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/36—Other treatment of blood in a by-pass of the natural circulatory system, e.g. temperature adaptation, irradiation ; Extra-corporeal blood circuits
    • A61M1/3693—Other treatment of blood in a by-pass of the natural circulatory system, e.g. temperature adaptation, irradiation ; Extra-corporeal blood circuits using separation based on different densities of components, e.g. centrifuging
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2202/00—Special media to be introduced, removed or treated
    • A61M2202/04—Liquids
    • A61M2202/0413—Blood
    • A61M2202/0427—Platelets; Thrombocytes
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L2400/00—Moving or stopping fluids
    • B01L2400/04—Moving fluids with specific forces or mechanical means
    • B01L2400/0475—Moving fluids with specific forces or mechanical means specific mechanical means and fluid pressure
    • B01L2400/0478—Moving fluids with specific forces or mechanical means specific mechanical means and fluid pressure pistons
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B04—CENTRIFUGAL APPARATUS OR MACHINES FOR CARRYING-OUT PHYSICAL OR CHEMICAL PROCESSES
    • B04B—CENTRIFUGES
    • B04B11/00—Feeding, charging, or discharging bowls
    • B04B11/02—Continuous feeding or discharging; Control arrangements therefor
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B04—CENTRIFUGAL APPARATUS OR MACHINES FOR CARRYING-OUT PHYSICAL OR CHEMICAL PROCESSES
    • B04B—CENTRIFUGES
    • B04B7/00—Elements of centrifuges
    • B04B7/02—Casings; Lids

Definitions

  • the present invention relates to the technical field of liquid collection and separation, in particular to a liquid separation kit combining extraction and multiple separation of liquids.
  • PRP platelet-rich plasma
  • the high-concentration platelet plasma is a platelet concentrate obtained by separating PRP from whole blood through a separation vessel and constant speed centrifugation according to the different sedimentation coefficients of the components in the blood.
  • the treatment process is quite safe, and the autologous blood is easy to obtain, and there is no allergy or rejection phenomenon, so it has been widely used in the treatment of arthritis, shoulder/hip/knee/ankle, etc. Joint pain, muscle sprain, tendon and ligament injury, cartilage injury, poor healing after fracture and other diseases.
  • the separation container used by medical personnel today usually contains at least two parts of a collection part and a separation part, that is, a syringe (that is, the aforementioned collection part) is used to collect blood from the patient's own body and then inject it into the separation test tube (that is, the aforementioned In the so-called separator), after centrifugation with a separator (or centrifuge), high-concentration platelet plasma is obtained.
  • a separation part that is, a syringe (that is, the aforementioned collection part) is used to collect blood from the patient's own body and then inject it into the separation test tube (that is, the aforementioned In the so-called separator), after centrifugation with a separator (or centrifuge), high-concentration platelet plasma is obtained.
  • a separator or centrifuge
  • Chinese Patent Application No. CN 201680036560.X discloses a multi-structured mother-in-law syringe, which can directly collect high-concentration plasma into the syringe without opening the cover; However, in fact, the child and mother syringes still belong to two separate devices, and different first syringes and second syringes are added in different steps. As in the traditional way, during the separation process, It is necessary to use different devices for transmission and separation; although, the mother and daughter syringe may reduce the risk of human error and external contamination, etc.; however, when the number of blood sources is large, the operator may not be able to guarantee multiple insertions. In the steps of pulling and separating, it can still be ensured that they all come from the same blood source, which may lead to the risk of misplacement due to the need for frequent exchange of devices. May be life-threatening due to rejection due to low compatibility.
  • the present invention provides a liquid separation kit to solve the deficiencies of the prior art.
  • the first object of the present invention is to provide a liquid separation kit, which can realize the extraction of whole blood to the separation of various components of the blood in the same cylinder, so as to achieve the purpose of preventing blood from being polluted.
  • the second object of the present invention is to obtain a high concentration of a certain blood component, such as platelets, plasma, red blood cells, etc., by at least two separation methods according to the above-mentioned liquid separation kit.
  • a certain blood component such as platelets, plasma, red blood cells, etc.
  • the third object of the present invention is to achieve the purpose of preparing a certain high-concentration component according to the above-mentioned liquid separation kit.
  • a liquid separation kit of the present invention can simultaneously accommodate a first component and a second component of a liquid after separation.
  • the liquid separation kit includes a cylinder, a communication piece, a control module and a piston.
  • the cylinder body forms a first chamber and a second chamber respectively having a free end and a connecting end.
  • the first chamber can accommodate the liquid or the first component and the second chamber can accommodate the second component.
  • the communication piece has a first end and a second end. The first end is connected to the connection end of the first chamber.
  • the control module includes a plurality of pipelines and a conduction control element.
  • the conduction control member is coupled to the pipelines. The conduction and cut-off between the pipelines are determined by operating the conduction control element.
  • the pipelines are respectively connected to the second end, the second chamber and the free end of the second chamber.
  • the piston is arranged in the first chamber, and a suction force or a thrust force can be determined to be generated at the connecting end of the first chamber by moving the position of the piston in the first chamber.
  • the liquid separation kit further includes a top cover disposed on the free end of the first chamber to confine the piston in the first chamber.
  • the second end and the free end of the second chamber are connected by operating the conduction control member, and when the piston moves from the connecting end of the first chamber to the direction of the free end of the first chamber, The liquid is sucked into the first chamber from the free end of the second chamber.
  • the second end and the second chamber are connected by operating the conduction control member, when the piston moves from the free end of the first chamber to the direction of the connecting end of the first chamber, it is used to switch from the second end to the second chamber.
  • a chamber pushes the second component into the second chamber.
  • the second end and the free end of the second chamber are connected by operating the conduction control member, and when the piston moves from the free end of the first chamber to the direction of the connecting end of the first chamber, The first component is pushed from the first chamber to the free end of the second chamber.
  • the piston is actuated by the external force generated by the traction mechanism, so as to change the position of the piston in the first chamber.
  • the liquid separation kit further includes a screw connection piston, which is driven by an external force to change the position of the piston in the first chamber.
  • the liquid separation kit further includes a bottom cover coupled to the connecting end of the second chamber to prevent the connecting end of the second chamber from communicating with the outside of the cylinder.
  • the second chamber is further formed with an observation area to expose the second end for observing at least one of the liquid, the first component and the second component at the second end.
  • the observation area is formed by at least one of a stopper and a stopper.
  • the present invention provides a liquid separation kit, which can be separated from the liquid to obtain the first component, The second component, etc., and the present invention provides an integrated cylinder for blood collection, separation, storage, etc., which can avoid the concern of contamination caused by the exchange and transmission of liquids in different cylinders.
  • the liquid separation kit can obtain whole blood blood from subjects, blood bags, blood collection devices (such as other needles), etc.
  • the red blood cells, platelets and the rest of the components are separated out, and then the platelets and the rest of the components are centrifuged a second time to extract high-concentration platelets.
  • FIG. 1 is a schematic cross-sectional view of a liquid separation kit according to a first embodiment of the present invention.
  • FIG. 2 is a schematic cross-sectional view of a liquid separation kit according to a second embodiment of the present invention.
  • FIG 3 is a schematic cross-sectional view of a liquid separation kit according to a third embodiment of the present invention.
  • FIG. 4 is a schematic cross-sectional view of a liquid separation kit according to a fourth embodiment of the present invention.
  • FIG. 5 is a schematic cross-sectional view of a liquid separation kit according to a fifth embodiment of the present invention.
  • FIG. 6 is a schematic cross-sectional view of a liquid separation kit according to a sixth embodiment of the present invention.
  • FIG. 7A is a schematic diagram illustrating blood collection in the liquid separation kit according to the embodiment of the present invention.
  • FIG. 7B is a schematic diagram illustrating the delivery of blood and the provision of separation by a fluid separation kit according to an embodiment of the present invention.
  • FIG. 8 is a schematic diagram illustrating the state of the liquid separation kit of the embodiment of the present invention after centrifugation.
  • FIG. 9A is a schematic diagram illustrating the state of the first separation of the liquid separation kit according to the embodiment of the present invention.
  • FIG. 9B is a schematic diagram illustrating the delivery of blood and the provision of re-separation in a fluid separation kit according to an embodiment of the present invention.
  • the terms “comprising”, “including”, “having”, “containing” or any other similar terms are intended to cover non-exclusive inclusions.
  • an element, structure, article or device containing a plurality of elements is not limited to those elements listed herein, but may include not explicitly listed but generally inherent to the element, structure, article or device other requirements.
  • the term “or” refers to an inclusive “or” and not an exclusive “or”.
  • FIG. 1 is a schematic cross-sectional view of the liquid separation kit according to the first embodiment of the present invention.
  • the liquid separation kit 10 is capable of simultaneously containing a first component 4 (see FIGS. 8 , 9A and 9B ) and a second component of a liquid 2 (see FIGS. 7A and 7B ) after separation 6 (see Figures 8, 9A and 9B).
  • a first component 4 see FIGS. 8 , 9A and 9B
  • a second component of a liquid 2 see FIGS. 7A and 7B
  • separation 6 see Figures 8, 9A and 9B
  • PRP high-concentration platelet plasma
  • whole blood refers to human blood, which can be directly collected from the human body or indirectly collected through, for example, a blood bag, a test tube, or the like.
  • Human blood is divided into two parts: plasma and blood cells. Among them, plasma accounts for about 55% of the total blood volume, while blood cells account for about 45%. Plasma is slightly yellowish, of which about 90% is water, 7-8% is plasma protein, and the rest is nutrients, waste or gas. There are many kinds of proteins in plasma, such as antibodies, hormones, enzymes, etc., which have various important functions. Blood cells can be divided into red blood cells, white blood cells and platelets, etc., and each share the functions of gas transport, disease defense and blood coagulation.
  • liquid separation kit when medical personnel (also referred to as users) use the liquid separation kit in this embodiment, they can be used in conventional centrifuges or by other external forces such as centrifugation, shaking, and shaking to perform whole blood separation operations.
  • the liquid separation kit 10 includes a cylinder 12 , a communication member 14 , a control module 16 and a piston 18 .
  • the cylindrical body 12 is formed to have a first chamber 122 and a second chamber 124 respectively.
  • the appearance shape of the cylinder body 12 can be a cylinder, which is similar to the shape of a test tube commonly used in laboratories at present, but the present invention does not limit the specific appearance shape, and those skilled in the art should know that an appropriate appearance shape can be made according to practical applications. .
  • the first chamber 122 forms a free end 1222 and a connection end 1224 .
  • the first chamber 122 can accommodate the liquid 2 or the first component 4.
  • the main components of the first component 4 are platelets, plasma, and the like.
  • the second chamber 124 forms a free end 1242 and a connection end 1244 .
  • the second accommodating chamber 124 is capable of accommodating the second component 6 .
  • the main component of the second component 6 is red blood cells.
  • the communicating member 14 forms a first end 142 and a second end 144 .
  • the first end 142 of the communication member 14 is connected to the connection end 1224 of the first chamber 122 .
  • the connection modes of the communicating member 14 , the first chamber 122 and the second chamber 124 are roughly divided into several types, for example, as follows:
  • Aspect 1 is shown in FIG. 1 of this embodiment.
  • a part of the communication member 14 of the liquid separation kit 10 is exposed between the first chamber 122 and the second chamber 124 , and the rest of the communication member 14 can be disposed inside the second chamber 124 or is external.
  • the rest of the communication member 14 is described as being disposed inside the second chamber 124 as an example.
  • FIG. 2 shows a schematic cross-sectional view of the liquid separation kit according to the second embodiment of the present invention.
  • the communication member 14 of the liquid separation kit 10 ′ is disposed in the second chamber 124 and the second end 144 extends toward the free end 1242 of the second chamber 124 , so that the second end 144 is accommodated in the second chamber 124 .
  • Two chambers 124 Two chambers 124 .
  • FIG. 3 shows a schematic cross-sectional view of the liquid separation kit according to the third embodiment of the present invention.
  • a part of the communication member 14 of the liquid separation kit 10 ′′ is disposed outside the second chamber 124 and the second end 144 extends toward the free end 1242 of the second chamber 124 .
  • the control module 16 includes three pipelines 162 , 164 , 166 and a conduction control member 168 .
  • the number of pipelines may not be limited to three, but may be less than three or more than three.
  • Conduction control 168 is coupled to lines 162 , 164 , 166 .
  • the conduction control member 168 can be, for example, a valve body for adjusting the fluid path between the pipelines 162 , 164 , 166 , and the conduction and blocking of the pipelines 162 , 164 , 166 can be determined by operating the conduction control member 168 .
  • the aforementioned manner of operating the conduction control member 168 may be to adjust the fluid path by means of knobs, buttons, push rods, and the like.
  • the material of the pipelines 162, 164, 166 can be plastic, silicone, etc., and the hardness of the pipelines 162, 164, 166 can be freely selected, which is not limited.
  • the pipeline 162 is connected to the second end 144
  • the pipeline 164 is connected to the second chamber 124
  • the pipeline 166 is connected to the free end of the second chamber 124 .
  • the piston 18 is disposed in the first chamber 122, and by moving the position of the piston 18 in the first chamber 122, a suction force or a thrust force can be generated at the connecting end 1224 of the first chamber 122, for example, when the piston 18 is directed toward +Y When moving in the direction, the piston 18 acts on the connecting end 1224 of the first chamber 122 to generate suction; conversely, when the piston 18 moves in the -Y direction, the piston 18 acts on the connecting end 1224 of the first chamber 122 to generate thrust.
  • the aforementioned movement of the piston 18, for example, can be actuated by an external force generated by a traction mechanism, and the traction mechanism, such as vacuum, magnetic force, pulling force, thrust force, torsion force, etc., can be used to change the position of the piston 18 in the first chamber 122, An example of one of the embodiments will be provided later.
  • the present invention is not limited to any specific method, as long as it can act on the piston 18 to make the piston 18 move, it belongs to the scope of the present invention.
  • the suction or thrust generated by the connecting end 1224 of the first chamber 122 will also act on the second end 144 of the communicating piece 14 and then act on the pipeline 162, and through the adjustment of the conduction control member 168, the pipeline 164 or the pipeline 166 can also generate suction or thrust at the same time.
  • the aforementioned suction force or thrust force can determine the movement of blood, plasma and blood cells in the first chamber 122 , the communication member 14 , the first chamber 124 and the like by operating the conduction control member 168 .
  • the liquid separation kit 10 includes a top cover 20 and a bottom cover 22 in addition to the cylindrical body 12 , the communication member 14 , the control module 16 and the piston 18 of the first embodiment.
  • the liquid separation kit 10 can store the first component 4 and the second component 6 of the liquid 2 for separation processing and transportation at the back end.
  • the top cover 20 is disposed on the free end 1222 of the first chamber 122 to confine the piston 18 in the first chamber 122 or seal the first chamber 122 .
  • the bottom cover 22 is combined with the free end 1242 of the second chamber 124 to prevent the free end 1242 of the second chamber 124 from communicating with the outside of the cylinder 12 .
  • the liquid separation kit 10 in addition to the barrel 12 , the communication member 14 , the control module 16 and the piston 18 of the first embodiment, the liquid separation kit 10 also includes a screw 24 .
  • the screw 24 is connected to the piston 18 , which is driven by the external force F to change the position of the piston 18 arranged in the first chamber 122 .
  • a corresponding female thread can be formed in a part of the inside of the piston 18 to combine with the male thread at the end of the screw 24, and the screw 24 and the piston 18 can be firmly connected by screwing the male thread into the female thread , so that the external force F can change the position of the piston 18 in the first chamber 122 by moving the screw 24 in the +Y or -Y direction.
  • the female thread can also be formed by a sleeve (not shown) at the end of the screw 24
  • the male thread can also be formed by a protrusion (not shown) at the piston 18 .
  • the screw 24 is only used in one embodiment to change the position of the piston 18 in the first chamber 122 .
  • other traction mechanisms can also be used to generate the external force F.
  • the liquid separation kit 10 in addition to the cylindrical body 12 , the communication member 14 , the control module 16 and the piston 18 of the first embodiment, the liquid separation kit 10 also includes an observation area 26 formed in the second chamber 124 .
  • the observation area 26 is mainly used for exposing the communication member 14 so as to be able to observe the liquid 2 , the first component 4 , and the second component 6 in the communication member 14 .
  • the communication member 14 since the communication member 14 is disposed in the second chamber 124 (see FIG. 1 ), if the second component 6 is red blood cells, it may obstruct the communication member 14 and affect the observation or operation.
  • 26 can connect the communication piece 14 and the inner edge side wall of the second chamber 124 through, for example, a stopper, a stopper, a bump (not shown), etc., by isolating the red blood cells, the transparent bump is adjacent to the second chamber.
  • the barrel 12 of 124 forms the viewing area 26 .
  • observation area 26 may be formed by other methods or objects, which are not limited thereto. Furthermore, in the case of the third embodiment, since the communication member 14 is exposed outside the second chamber 124 , it will not be disturbed and shielded by the second component 6 , and there is no need to form the observation area 26 .
  • FIG. 7A a schematic diagram is shown exposing the liquid separation kit 10 to take blood.
  • the control module 16 of the liquid separation kit 10 is operated so that the pipeline 162 is connected to the pipeline 166, and the screw 24 is combined with the piston 18, and is moved in the +Y direction by the external force F, so that in the second
  • the free end 1242 of the chamber 124 generates suction to obtain the liquid 2 from the human body or from a container (not shown) storing the liquid 2, such as a blood bag, a test tube, and the like.
  • the liquid 2 is stored in the first chamber 122 .
  • FIG. 7B a schematic diagram is shown exposing the fluid separation kit 10 to deliver blood and provide separation.
  • the control module 16 of the liquid separation kit 10 is operated to block the communication between the pipeline 162 and the rest of the pipelines, and the liquid separation kit 10 removes the screw 24 and places it in the first chamber 122 (see FIG. 7A )
  • the free end 1222 (see FIG. 1 ) of the top cover 20 and the free end 1242 (see FIG. 7A ) of the second chamber 124 (see FIG. 7A ) are provided with the bottom cover 22 to store the liquid 2 in the first chamber 122 .
  • FIG. 8 a schematic diagram of the state after the centrifugation of the liquid separation kit 10 is disclosed.
  • the liquid 2 forms the first component 4 and the second component 6 in the first chamber 122 (see FIG. 1 )
  • the first component 4 can be platelets and other components; and, the second component 6 can be red blood cells.
  • FIG. 9A it is a schematic diagram showing the state of exposing the liquid separation kit 10 to perform the first separation.
  • the control module 16 of the liquid separation kit 10 is operated to make the pipeline 162 and the pipeline 164 conduct, and the screw 24 is combined with the piston 18, and is moved in the -Y direction by the external force F, so that the first The component 4 and the second component 6 are pushed from the connecting end 1224 of the first chamber 122 to the connecting member 14 .
  • the second component 6 first enters the connecting member 14 and then enters the second chamber 124 through the pipeline 164 ( See Figure 1).
  • the application of the external force F is stopped. There is little or no second component 6 with the first chamber 122 .
  • FIG. 9B a schematic diagram is shown exposing the fluid separation kit 10 to deliver blood and provide re-separation.
  • the control module 16 of the liquid separation kit 10 is operated again to block the conduit 162 (refer to FIG. 9A ) from communicating with the rest of the conduits, and the liquid separation kit 10 removes the screw 24 and places it in the first chamber.
  • the free end 1222 (see FIG. 1 ) of the 122 (see FIG. 1 ) is provided with the top cover 20 and the free end 1242 (see FIG. 1 ) of the second chamber 124 (see FIG.
  • the first component 4 forms a high concentration of the first component 4 ′ and other components in the first chamber 122 .
  • the control module 16 of the liquid separation kit 10 can be connected to the pipeline 166 by the operation pipeline 162 , so that the high-concentration first component 4 ′ can be output to the outside of the cylinder 12 .

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Abstract

一种液体分离套件，借由筒体（12）上的导通控制件（168），提供使用者可选择性地控制以隔离或连通第一容室（122）与筒体（12）外部，及连通第一容室（122）与第二容室（124），简易地通过分离过程获得例如高浓度的第一成分。

Description

液体分离套件 技术领域
本发明是关于液体采集分离的技术领域，特别是一种结合抽取与多次分离液体的液体分离套件。
背景技术
在某些特定研究、实验、临床试验等应用中，需要取得液体的某一特定成分及其浓度。在传统作法中，是在不同步骤中利用不同的器件执行抽吸、分离、排出、储存等工作，在执行过程中，由于涉及液体在不同器件之间的工作，有可能液体遭受污染，进而影响例如纯度或浓度，进而影响最终的效果。
举例而言，为了取得高浓度富血小板血浆(Platelet-rich plasma，PRP)是根据血液中各组成成分沉降系数不同，通过分离容器及定转速离心法将PRP从全血中分离出来的血小板浓缩物。由于高浓度血小板血浆是源于病人自体，所以治疗过程相当安全，而且自体血液容易取得，也不会有过敏或排斥现象，因此已广泛被用于治疗关节炎、肩/髋/膝/踝等关节疼痛、肌肉扭伤、肌腱韧带损伤、软骨损伤、骨折后愈合不良等病症上。
现今医疗人员使用的分离容器通常是包含采集件与分离件之至少分两个器件，亦即以注射筒(即是前述所称之采集件)于病人自体采集血液再注入分离试管(即是前述所称之分离件)内，以分离机(或称离心机)经离心之后，得到高浓度血小板血浆。由于离心过程十分繁琐，会因PRP浓缩倍率不同，增加临床应用上的困难度，而且过程中需要多种器件，增加血液被污染的机会。
中国专利申请号CN 201680036560.X公开了一种多重结构的子母注射筒，其可在不开盖状态下，直接收集高浓度血浆至注射筒中；然而，子母注射筒虽可以在不开盖的状态下进行收集，但是实际上，子母注射筒仍属于两个分离的器件，其在不同的步骤中加入不同的第一注射器与第二注射器，其如同传统的方式，在分离过程中，需要使用到不同的器件用于传输而进行分离； 虽然，子母注射筒可能可以降低人为疏失与外界污染等的风险；但是，当血液来源数量多的时候，操作人员可以无法保证在多次插拔、分离等过步骤中，仍可以确保都是来自于同一个血液来源，有可能因为需要经常性交换器件而导致于错置的风险，轻者可能因为剂量小而发生副作用小，重者有可能因为相容性低而造成排斥而危及生命。
有鉴于此，本发明提供了一种液体分离套件，以解决先前技术的缺失。
发明内容
本发明的第一目的是提供一种液体分离套件，能够在同一筒体中实现抽取全血到分离血液各成分，以达到血液不受到污染的目的。
本发明的第二目的是根据上述的液体分离套件，借由至少二次的分离方式取得高浓度某一血液成分，例如血小板、血浆、红血球等成分的目的。
本发明的第三目的是根据上述的液体分离套件，能够达到制备某一高浓度成分的目的。
为达到上述目的或其他目的，本发明一种液体分离套件能够同时地容置经分离之后一液体的一第一成分与一第二成分。液体分离套件包含一筒体、一连通件、一控制模组与一活塞。筒体形成分别地具有一自由端与一连接端的一第一容室与一第二容室。其中，第一容室能够容置液体或第一成分和第二容室能够容置第二成分。连通件具有一第一端与一第二端。该第一端连接该第一容室之连接端。其中，连通件之一部分显露于第一容室与第二容室之间，或者其中，连通件之一部分设置第二容室之外部且让第二端朝第二容室之自由端方向延伸，或者其中，连通件设置第二容室中且让第二端朝第二容室之自由端方向延伸，使得第二端容置于第二容室。控制模组包含复数管路与一导通控制件。导通控制件耦接该等管路。借由操作导通控制件以决定该等管路之间的导通与截止。该等管路分别地连接第二端、第二容室与第二容室之自由端。活塞设置于第一容室，借由移动活塞在该第一容室的位置而能够决定在第一容室的连接端产生一吸力或一推力。
于一实施例中，液体分离套件还包括顶盖设置于第一容室之自由端，以将活塞限位于第一容室。
于一实施例中，借由操作导通控制件导通第二端与第二容室之自由端，在活塞由第一容室之连接端朝第一容室之自由端的方向移动时，用于从第二 容室之自由端将液体吸入第一容室。
于一实施例中，借由操作导通控制件导通第二端与第二容室，在活塞由第一容室之自由端朝第一容室之连接端的方向移动时，用于从第一容室将第二成分推挤至第二容室。
于一实施例中，借由操作导通控制件导通第二端与第二容室之自由端，在活塞由第一容室之自由端朝第一容室之连接端的方向移动时，用于从第一容室将第一成分推挤至第二容室之自由端。
于一实施例中，活塞受牵引机制所产生的外力而作动，以改变活塞位于第一容室的位置。
于一实施例中，液体分离套件还包括螺杆连接活塞，其受外力驱动而改变活塞设置在第一容室的位置。
于一实施例中，液体分离套件还包括底盖结合于第二容室之连接端，以阻挡第二容室之连接端连通筒体的外部。
于一实施例中，第二容室还形成有观察区域，以显露第二端而供观察在第二端的液体、第一成分与第二成分之至少一者。
于一实施例中，观察区域由挡块与挡件之至少一者所构成。
相较于习知技术，本发明提供一种液体分离套件，能够在多次(例如两次)离心、震动、晃动、扰动、摇动、沉积等作用之下，自液体分离以取得第一成分、第二成分等，且本发明提供采血、分离、保存等一体式筒体，可以避免液体在不同筒体交换与传输而导致污染的疑虑。
于一实施例中，液体是以血液为例时，液体分离套件可以从受试者、血袋、采血器(例如其他针头)等取得全血的血液，经过第一次离心时，可以从血液中分离出红血球、血小板与其余的成分，接着对血小板与其余的成分进行第二次离心，可以萃取高浓度的血小板。
附图说明
图1是本发明第一实施例之液体分离套件之剖面示意图。
图2是本发明第二实施例之液体分离套件之剖面示意图。
图3是本发明第三实施例之液体分离套件之剖面示意图。
图4是本发明第四实施例之液体分离套件之剖面示意图。
图5是本发明第五实施例之液体分离套件之剖面示意图。
图6是本发明第六实施例之液体分离套件之剖面示意图。
图7A是说明本发明实施例之液体分离套件采取血液的示意图。
图7B是说明本发明实施例之液体分离套件运送血液与提供分离的示意图。
图8是说明本发明实施例之液体分离套件离心后的状态示意图。
图9A是说明本发明实施例之液体分离套件进行第一次分离的状态示意图。
图9B是说明本发明实施例之液体分离套件运送血液与提供再次分离的示意图。
具体实施方式
为充分了解本发明之目的、特征及功效，兹借由下述具体之实施例，并配合所附之图式，对本发明做一详细说明，说明如后：
于本发明中，使用“一”或“一个”来描述本文所述的单元、元件和组件。此举只是为了方便说明，并且对本发明之范畴提供一般性的意义。因此，除非很明显地另指他意，否则此种描述应理解为包括一个、至少一个，且单数也同时包括复数。
于本文中，用语“包含”、“包括”、“具有”、“含有”或其他任何类似用语意欲涵盖非排他性的包括物。举例而言，含有复数要件的一元件、结构、制品或装置不仅限于本文所列出的此等要件而已，而是可以包括未明确列出但却是该元件、结构、制品或装置通常固有的其他要件。除此之外，除非有相反的明确说明，用语“或”是指涵括性的“或”，而不是指排他性的“或”。
请参考图1，本发明第一实施例之液体分离套件之剖面示意图。在图1中，液体分离套件10能够同时地容置经分离之后一液体2(参见图7A和图7B)的一第一成分4(参见图8、图9A和图9B)与一第二成分6(参见图8、图9A和图9B)。于此，为了便于说明，以全血分离而取得高浓度血小板血浆(PRP)为例说明，于其他实施例中，可以应用在任何需要分离成分的具有液态状的溶液。于此，全血指的是人体血液，其可以直接自人体采血或是间接通过例如血袋、试管等采集血液。人体血液分为血浆和血球两部分。其中，血浆约占全部血液量的55％，而血球约占45％。血浆略呈淡黄色，其中成分里约90％是水、7～8％是血浆蛋白，其余为养分、废物或气体等。血浆的蛋 白质种类繁多，如抗体、激素、酵素等，具有各种重要功能。血球可分为红血球、白血球和血小板等，各自分担气体运输、防御疾病和血液凝固等功能。
另外，医疗人员(亦称使用者)在应用本实施例中液体分离套件时，其可以应用在传统的离心机或是通过其他方式的离心、晃动、摇动等外力，执行全血的分离操作。
液体分离套件10包含一筒体12、一连通件14、一控制模组16与一活塞18。
筒体12形成分别地具有一第一容室122与一第二容室124。于此，筒体12之外观形状可为圆柱体，类似目前实验室常见的试管型状，但本发明并不限定具体的外观形状，熟此技术者当知可依照实际应用做出适当的外观形状。
第一容室122形成一自由端1222与一连接端1224。其中，第一容室122能够容置液体2或第一成分4，于本实施例中，第一成分4主要成分为血小板、血浆等。
第二容室124形成一自由端1242与一连接端1244。其中，第二容室124能够容置第二成分6，于本实施例中，第二成分6主要成分为红血球。
连通件14形成一第一端142与一第二端144。连通件14的第一端142连接第一容室122的连接端1224。连通件14、第一容室122与第二容室124的连接态样大致区分为数种，于此举例如下：
态样一，如本实施例图1所示。
在态样一中，液体分离套件10之连通件14之一部分显露于第一容室122与第二容室124之间，其连通件14的其余部分可以设置于第二容室124的内部或是外部。于此，连通件14的其余部分以设置在第二容室124内部为例说明。
态样二，可参考图2，示出了本发明第二实施例的液体分离套件的剖面示意图。
在态样二中，液体分离套件10'之连通件14设置第二容室124中且让第二端144朝第二容室124之自由端1242方向延伸，使得第二端144容置于第二容室124。
态样三，可参考图3，示出了本发明第三实施例之液体分离套件之剖面示意图。
在态样三中，液体分离套件10"之连通件14之一部分设置第二容室124 之外部且让第二端144朝第二容室124之自由端1242方向延伸。
回到图1，控制模组16包含三个管路162,164,166与一导通控制件168。于其他实施例中，管路的数量可以不只有局限在三个，可以少于三个或是多于三个。导通控制件168耦接管路162,164,166。导通控制件168例如可以是阀体，用以在管路162,164,166之间进行流体路径的调节，借由操作导通控制件168可以决定管路之间162,164,166的导通与截止。前述操作导通控制件168的方式，可以是通过旋钮、按钮、推杆等方式进行流体路径的调节。再者，管路162,164,166的材质可以塑胶、矽胶等，且管路162,164,166的软硬可以自由地选择，于此不限制。于本实施例中，管路162连接第二端144、管路164连接第二容室124与管路166连接第二容室124之自由端。
活塞18设置于第一容室122，借由移动活塞18在第一容室122的位置而能够决定在第一容室122的连接端1224产生一吸力或一推力，例如当活塞18朝+Y方向移动时，活塞18作用在第一容室122的连接端1224以产生吸力；反之，当活塞18朝-Y方向移动时，活塞18作用在第一容室122的连接端1224以产生推力。前述活塞18的移动方式，例如可以通过受牵引机制所产生的外力而作动，其牵引机制例如真空、磁力、拉力、推力、扭力等，可用于改变活塞18在第一容室122的位置，于后将提供其中一种实施方式示例说明，本发明不限于使用哪一种特定的方式，只要能够作用于活塞18，使得活塞18产生移动，即属于本发明的范畴。
由于连接端1224是与连通件14的第一端142连接，故第一容室122的连接端1224所产生的吸力或推力也会作用于连通件14的第二端144，进而作用于管路162，且通过导通控制件168的调节，让管路164或管路166也同时地产生吸力或推力。换言之，前述的吸力或推力可以借由操作导通控制件168，可以决定血液、血浆和血球在第一容室122、连通件14、第一容室124等的移动。
参考图4，示出了本发明第四实施例之液体分离套件之剖面示意图。在图4中，液体分离套件10除包含第一实施例的筒体12、连通件14、控制模组16与活塞18之外，还包括一顶盖20与一底盖22。于本实施例中，液体分离套件10可以存放液体2的第一成分4与第二成分6，用于后端的分离处理与运送等。
筒体12、连通件14、控制模组16与活塞18的说明如前所述，于此不赘 述。
顶盖20设置于第一容室122之自由端1222，以将活塞18限位于第一容室122或密封第一容室122。
底盖22结合于第二容室124之自由端1242，以阻挡第二容室124之自由端1242连通筒体12的外部。
参考图5，示出了本发明第五实施例之液体分离套件之剖面示意图。在图5中，液体分离套件10除包含第一实施例的筒体12、连通件14、控制模组16与活塞18之外，还包括螺杆24。
筒体12、连通件14、控制模组16与活塞18的说明如前所述，于此不赘述。
螺杆24连接活塞18，其受外力F驱动而改变活塞18设置在第一容室122的位置。其中，螺杆24连接活塞18的方式，例如可以在活塞18内部之一部分形成对应的母螺纹以结合螺杆24末端的公螺纹，借由公螺纹旋入母螺纹，而稳固地连接螺杆24与活塞18，使得外力F能够通过使螺杆24在+Y或-Y方向移动，而改变活塞18位于该第一容室122的位置。在前述的实施例中，母螺纹也可以在螺杆24末端借由套筒(图未示)型态形成，而公螺纹也可以在活塞18借由凸块(图未示)型态形成。
值得注意的是，螺杆24仅是用于其中一实施例，用于改变活塞18在第一容室122的位置，于其他实施例中，也可以改由其他的牵引机制产生外力F。
参考图6，示出了本发明第六实施例之液体分离套件之剖面示意图。在图6中，液体分离套件10除包含第一实施例的筒体12、连通件14、控制模组16与活塞18之外，还包括在第二容室124形成的观察区域26。
筒体12、连通件14、控制模组16与活塞18的说明如前所述，于此不赘述。
观察区域26主要用于显露连通件14而能够观察在连通件14中的液体2、第一成分4、第二成分6。于本实施例中，由于连通件14是设置于第二容室124(参见图1)，若第二成分6是红血球，因其有可能遮蔽连通件14而影响观察或是操作，则观察区域26可以通过例如挡块、挡件、凸块(图未示)等连接连通件14与第二容室124的内缘侧壁，借由隔离红血球，让透明凸块在邻近于第二容室124的筒体12形成观察区域26。
值得注意的是，观察区域26区域可以通过其他方式或是物件所形成，于此不限。再者，若为例如第三实施例，由于连通件14显露于第二容室124的外部，因此，不会受到第二成分6的干扰遮蔽，而无需形成观察区域26。
参考图7A和图7B、图8以及图9A和图9B，示出了说明本发明各实施例之液体分离套件之操作示意图。
在图7A中，示出了揭露液体分离套件10采取血液的示意图。在图7A中，液体分离套件10的控制模组16被操作以使得管路162与管路166导通，又螺杆24结合活塞18，并且借由外力F朝+Y方向移动，以在第二容室124的自由端1242产生吸力，以自人体取得液体2或是自储存液体2的容器(图未示)取得液体2，例如容器可以为血袋、试管等。液体2被储存在第一容室122。
在图7B中，示出了揭露液体分离套件10运送血液与提供分离的示意图。在图7B中，液体分离套件10的控制模组16被操作以阻挡管路162与其余的管路导通，又液体分离套件10拆除螺杆24，并在第一容室122(参见图7A)的自由端1222(参见图1)设置顶盖20与第二容室124(参见图7A)的自由端1242(参见图7A)设置底盖22，以将液体2储存在第一容室122。
在图8中，示出了揭露液体分离套件10离心后的状态示意图。在图8中，在液体分离套件10通过例如离心机(图未示)进行第一次的离心之后，液体2在第一容室122(参见图1)形成第一成分4与第二成分6，例如第一成分4可为血小板与其他成分等；以及，第二成分6可为红血球。
在图9A中，示出了揭露液体分离套件10进行第一次分离的状态示意图。在图9A中，液体分离套件10的控制模组16被操作以使得管路162与管路164导通，又螺杆24结合活塞18，并且借由外力F朝-Y方向移动，以将第一成分4与第二成分6自第一容室122的连接端1224推挤至连接件14，于此，第二成分6先进入连接件14，进而通过管路164进入到第二容室124(参见图1)。于本实施例中，当观察第二成分6几乎或完全进入第二容室124之后，则停止施加外力F，换言之，第二成分6主要都被储存在第二容室124，在连通件14与第一容室122仅存在极少或是什至不存在第二成分6。
在图9B中，示出了揭露液体分离套件10运送血液与提供再次分离的示意图。在图9B中，液体分离套件10的控制模组16再被操作以阻挡管路162(参见图9A)与其余的管路导通，又液体分离套件10拆除螺杆24，并在第 一容室122(参见图1)的自由端1222(参见图1)设置顶盖20与第二容室124(参见图1)的自由端1242(参见图1)设置底盖22；又，液体分离套件10通过例如离心机(图未示)进行第二次的离心之后，第一成分4在第一容室122形成高浓度的第一成分4'与其他成分。于其他实施例中，液体分离套件10的控制模组16可被操作管路162导通管路166，使得高浓度的第一成分4'可以被输出至筒体12的外部。
本发明在上文中已以较佳实施例揭露，然熟习本项技术者应理解的是，该实施例仅用于描绘本发明，而不应解读为限制本发明之范围。应注意的是，举凡与该实施例等效之变化与置换，均应设为涵盖于本发明之范畴内。因此，本发明之保护范围当以申请专利范围所界定者为准。
【符号说明】
2…液体
4…第一成分
6…第二成分
10、10'、10"…液体分离套件
12…筒体
122…第一容室
1222…自由端
1224…连接端
124…第二容室
1242…自由端
1244…连接端
14…连通件
142…第一端
144…第二端
16…控制模组
162、164、166…管路
168…导通控制件
18…活塞
20…顶盖
22…底盖
24…螺杆
26…观察区域
F…外力

Claims (10)

  1. 一种液体分离套件，用于同时地容置经分离之后液体的第一成分与第二成分，该液体分离套件包含：
    筒体，分别地形成具有自由端与连接端的第一容室与第二容室，其中该第一容室供容置该液体或该第一成分和该第二容室供容置该第二成分；
    连通件，具有第一端与第二端，该第一端连接该第一容室之连接端，其中，该连通件之一部分显露于该第一容室与该第二容室之间，或者其中，该连通件之一部分设置该第二容室之外部且让该第二端朝该第二容室之自由端方向延伸，或者其中，该连通件设置该第二容室中且让该第二端朝该第二容室之自由端方向延伸，使得该第二端容置于该第二容室；
    控制模组，具有复数管路与导通控制件，该导通控制件耦接该等管路，借由操作该导通控制件以决定该等管路之间的导通与截止，该等管路分别地连接该第二端、该第二容室与该第二容室之自由端；以及
    活塞，设置于该第一容室，借由移动该活塞在该第一容室的位置而供决定在该第一容室的该连接端产生吸力或推力。
  2. 如权利要求1所述的液体分离套件，还包括顶盖，设置于该第一容室之自由端，以将该活塞限位于该第一容室。
  3. 如权利要求1所述的液体分离套件，其中借由操作该导通控制件导通该第二端与该第二容室之自由端，在该活塞由该第一容室之连接端朝该第一容室之自由端的方向移动时，用于从该第二容室之自由端将该液体吸入该第一容室。
  4. 如权利要求1所述的液体分离套件，其中借由操作该导通控制件导通该第二端与该第二容室，在该活塞由该第一容室之自由端朝该第一容室之连接端的方向移动时，用于从该第一容室将该第二成分推挤至该第二容室。
  5. 如权利要求1所述的液体分离套件，借由操作该导通控制件导通该第二端与该第二容室之自由端，在该活塞由该第一容室之自由端朝该第一容室之连接端的方向移动时，用于从该第一容室将该第一成分推挤至该第二容室之自由端。
  6. 如权利要求3、4或5所述的液体分离套件，其中该活塞受牵引机制所产生的外力而作动，以改变该活塞位于该第一容室的位置。
  7. 如权利要求3、4或5所述的液体分离套件，还包括螺杆连接该活塞，其受外力驱动而改变该活塞设置在该第一容室的位置。
  8. 如权利要求1所述的液体分离套件，还包括底盖结合于该第二容室之自由端，以阻挡该第二容室之自由端连通该筒体的外部。
  9. 如权利要求1所述的液体分离套件，其中该第二容室还形成有观察区域，以显露该连通件而供观察在该连通件中的该液体、该第一成分与该第二成分之至少一者。
  10. 如权利要求9所述的液体分离套件，其中该观察区域由挡块、挡件与凸块之至少一者所构成。
PCT/CN2020/130737 2020-07-08 2020-11-23 液体分离套件 WO2022068023A1 (zh)

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