WO2019025914A1 - Dispositif de séparation de plasma - Google Patents

Dispositif de séparation de plasma Download PDF

Info

Publication number
WO2019025914A1
WO2019025914A1 PCT/IB2018/055594 IB2018055594W WO2019025914A1 WO 2019025914 A1 WO2019025914 A1 WO 2019025914A1 IB 2018055594 W IB2018055594 W IB 2018055594W WO 2019025914 A1 WO2019025914 A1 WO 2019025914A1
Authority
WO
WIPO (PCT)
Prior art keywords
plasma
blood
zone
blood sample
membrane
Prior art date
Application number
PCT/IB2018/055594
Other languages
English (en)
Inventor
Nalini K GUPTA
Original Assignee
Gupta Nalini K
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Gupta Nalini K filed Critical Gupta Nalini K
Publication of WO2019025914A1 publication Critical patent/WO2019025914A1/fr

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/02—Blood transfusion apparatus
    • A61M1/0281—Apparatus for treatment of blood or blood constituents prior to transfusion, e.g. washing, filtering or thawing
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/150007—Details
    • A61B5/150015—Source of blood
    • A61B5/150022—Source of blood for capillary blood or interstitial fluid
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/150007—Details
    • A61B5/150015—Source of blood
    • A61B5/15003—Source of blood for venous or arterial blood
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/150007—Details
    • A61B5/150351—Caps, stoppers or lids for sealing or closing a blood collection vessel or container, e.g. a test-tube or syringe barrel
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/150007—Details
    • A61B5/150755—Blood sample preparation for further analysis, e.g. by separating blood components or by mixing
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/153—Devices specially adapted for taking samples of venous or arterial blood, e.g. with syringes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/153—Devices specially adapted for taking samples of venous or arterial blood, e.g. with syringes
    • A61B5/154—Devices using pre-evacuated means
    • 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
    • A61M1/3621—Extra-corporeal blood circuits
    • A61M1/3627—Degassing devices; Buffer reservoirs; Drip chambers; Blood filters
    • A61M1/3633—Blood component filters, e.g. leukocyte filters
    • 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
    • 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
    • A61M2202/00—Special media to be introduced, removed or treated
    • A61M2202/04—Liquids
    • A61M2202/0413—Blood
    • A61M2202/0415—Plasma
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L2300/00—Additional constructional details
    • B01L2300/04—Closures and closing means
    • B01L2300/041—Connecting closures to device or container
    • B01L2300/044—Connecting closures to device or container pierceable, e.g. films, membranes
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L2300/00—Additional constructional details
    • B01L2300/06—Auxiliary integrated devices, integrated components
    • B01L2300/0681—Filter
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L2300/00—Additional constructional details
    • B01L2300/08—Geometry, shape and general structure
    • B01L2300/0832—Geometry, shape and general structure cylindrical, tube shaped
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L2300/00—Additional constructional details
    • B01L2300/12—Specific details about materials
    • B01L2300/123—Flexible; Elastomeric

Definitions

  • the present disclosure relates to separation of plasma/serum from whole blood.
  • it pertains to a device that allows extraction of plasma from whole blood sample directly into a tube/container or a fixed volume capacity capillary.
  • red blood cells can interfere with accuracy of the results.
  • whole blood is collected from a patient and sent to a lab for analysis. If the lab is not in close proximity, then the samples must be preserved e.g. refrigerated, until they reach the lab. In the lab, technicians use centrifuges to separate blood cells from whole blood. Once the plasma or serum has been separated, it can be used for further analysis.
  • United States Patent Number US6632681 Bl discloses a device that uses a flow-through matrix to separate filtrate with high yield. Pressure is applied to a reservoir container to force the sample through the flow-through matrix and out of the device for analysis. This device can be applied for plasma separation, but suffers from hemolysis which interferes with analytical tests.
  • the separation membrane is composed of two layers: the first layer impedes the motion of RBCs, so plasma can travel faster and the second layer acts as a size barrier for RBCs so only plasma can travel through. Pressure is used to drive blood through the stack.
  • United States Patent Number US 6170671 Bl discloses a method of regulating flow of blood by reducing outlet area of a membrane using a solid material thereby preventing hemolysis.
  • the device is limited in its ability to deliver plasma with good yield.
  • United States Patent Application US20140263059A1 presents a method that combines size exclusion filtration through a separation membrane and erythrocyte (RBC) agglutination.
  • the blood contacting side is treated with an agglutination agent to cluster RBCs so that it is harder for them to pass through the membrane. This allows for larger pore sizes and 200-400 ⁇ thick membranes, which facilitates higher throughput of plasma passage.
  • WIPO Patent Application WO2016073823 Al presents alternate methods of using a combination of filters and agglutination agents to extract plasma free of RBCs. However, they do not realize a device that is portable and cost-effective for ease of use in point-of-care setting.
  • United States Patent Number US7500569 B2 discloses a device for separating plasma from whole blood that includes an evacuated primary collection chamber capable of fluid communication through a porous filter to an evacuated secondary collection chamber.
  • An agglutinating agent is provided within the primary collection chamber so as to aggregate blood cells within a whole blood sample.
  • the porous filter has a pore size which is small enough to capture the aggregated blood cells therein, yet large enough to permit plasma to transfer there through under pressures associated with conventional evacuated blood collection tubes.
  • the primary and secondary collection chambers are provided in separate containers or tubes, with transfer occurring there between through a transfer device including the porous filter therein. The transfer device is provided to transfer plasma from the primary collection chamber to the secondary collection chamber.
  • European Patent Number EP 1909101 Bl discloses an instrument for separating blood cells and plasma/serum from blood, the instrument including a first hollow needle extending towards one end, a second hollow needle extending towards the other end, a tubular container having an inner space in which the blood flows and a blood separating membrane for separating the blood into blood cells and the plasma, wherein the container has a first channel for supplying the blood into the inner space through which the blood flows from the needle point of the first hollow needle into the inner space, a second channel for flowing out the blood from the inner space through which the blood flows from the inner space towards the needlepoint of the second hollow needle, and a third channel which allows air to flow from the outer space toward the needle point of the first hollow needle.
  • the instrument disclosed in the reference uses a plurality of needles and does not provide a container having an inner space at reduced pressure to provide efficient extraction of plasma.
  • United States Patent Number US 9427707 B2 discloses a means of reducing blood flow presented to an RBC filter situated in an evacuated tube by an external capillary or by a capillary inside the evacuated tube. Another method also describes the use of positive pressure to drive the plasma out and at the same time reducing the flow of blood through the filter by means of a pinhole.
  • the cost is high and the problem of transfer of plasma into another tube remains unresolved.
  • United States Patent Application US20150008187A1 discloses a blood pre- treating apparatus for filtering red blood cells (RBCs) and albumin from whole blood, which uses a filter unit packed with micro beads.
  • the micro bead surfaces can be functionalized to preferentially adsorb species e.g. albumin.
  • the use of micro beads could present challenges in assembly and cost of the device.
  • the numerical parameters set forth in the written description and attached claims are approximations that can vary depending upon the desired properties sought to be obtained by a particular embodiment. In some embodiments, the numerical parameters should be construed in light of the number of reported significant digits and by applying ordinary rounding techniques. Notwithstanding that the numerical ranges and parameters setting forth the broad scope of some embodiments of the invention are approximations, the numerical values set forth in the specific examples are reported as precisely as practicable. The numerical values presented in some embodiments of the invention can contain certain errors necessarily resulting from the standard deviation found in their respective testing measurements.
  • Yet another object of the present disclosure is to provide a plasma separation device that is compatible with workflow of high throughput automatic analyzers.
  • the present disclosure relates to separation of plasma/serum from whole blood, and more particularly, to a device that allows extraction of plasma from either a whole blood sample or blood of a patient directly into a tube/containeror a fixed volume capacity capillary.
  • the proposed plasma separation device includes a sample reservoir, an inlet port for supplying sample to the device, a flow director, a membrane stack with a reservoir for separated plasma, and an outlet opening for providing plasma directly to a tube/container.
  • the inlet port is an opening to introduce the sample (e.g. blood) into the device.
  • the sample reservoir is a space above the membrane stack to retain the sample and optionally consists of a fluid distributor, to direct the flow of the sample over the membrane.
  • the membrane stack is composed of at least three Zones in sequence:
  • a third zone of small pore filter matrix is a barrier for any residual cells and also acts as a reservoir for the plasma.
  • the reservoir filter matrix can be held in a narrower section than the rest of the membrane stack, to limit leakage from the edges.
  • the outlet opening can incorporate a nozzle shaped opening (e.g. nozzle) where free plasma or serum can be extracted, and can be designed to limit dead volume and to generate fixed sized droplets.
  • Blood can be introduced through the inlet port and can be collected in the sample reservoir.
  • the flow distributor can direct the sample flow towards center of the membrane to allow gradual and complete utilization of membrane surface and minimize leakage around edge of the membrane stack.
  • Blood can make contact with the first zone membrane on the blood contact side.
  • Capillary action and/or gravity and pressure and/or vacuum can be used to pull the blood and plasma through the stack.
  • the agglutination agent in the first zone can cause RBCs to cluster and impedes their flow through the subsequent zones of the membrane.
  • the collected plasma can be pushed out from the reservoir by applying positive pressure from the inlet port side, or by applying a negative pressure from the outlet opening. All the surfaces in contact with the blood including the membranes used in different zones can be treated with an inert polymer or protein or other chemicals to minimize adsorption of analytes of interest.
  • the first zone constitutes a first membrane layer can be treated with an agglutination agent (such as lectins) so as to induce clustering of the RBCs to make it difficult for them to travel through the membrane while plasma flows quickly.
  • an agglutination agent such as lectins
  • the agglutination agents can be applied in single or multiple alternating thin layers of agent transfer membranes and untreated large pore membranes for high efficiency. Large pore membrane has high void volume so that blood cells can park themselves and plasma passes through without risk of hemolysis.
  • the second Zone has a second membrane that can be treated with chemicals such as glycine or other polymers, which change the hydrophobic/hydrophilic balance to slow down the liquid flow which allows more efficient retention of RBC in the first zone as well as the second Zone.
  • the second Zone can be composed of multiple sub-layers of different materials, pore sizes and / or treatments (e.g. agglutination agents, glycine or other polymers), which act in different ways to impede the flow of RBC.
  • the third zone has the smallest pores in the stack and its interface layer with the second Zone acts as a barrier for any cells that can escape from the second Zone.
  • the third zone also acts as the reservoir for the plasma.
  • the construction of the device allows efficient separation under relatively high flow of blood without hemolysis. This reduces the time of separation and also increases the yield of plasma obtained.
  • the construction of outlet can be such that the plasma can be extracted in the form of well defined droplet of required size.
  • Part of the reservoir can be held in a smaller section than the rest of the membrane stack to limit leakage.
  • the membrane stack as well as materials of construction of the device can be treated with agents such as BSA or other proteins to limit adsorption of the analytes of interest.
  • the driving force for the plasma separation can be by capillary only or gravity and capillary or each of the above assisted by pressure from the inlet port side or vacuum from the outlet opening side or by both.
  • FIG. 1A and IB illustrates completely assembled device in accordance to an embodiment of the present disclosure.
  • FIG. 2 illustrates partially assembled device in accordance to an embodiment of the present disclosure.
  • FIGs.3 and 4 illustrate a portion of a device which is fitted on the proposed plasma separation device in accordance to an embodiment of the present disclosure.
  • FIG.5 illustrates the device with built-in stand in accordance to an embodiment of the present disclosure.
  • FIG.6 illustrates a fully assembled device in accordance to an embodiment of the present disclosure.
  • FIG.7 illustrates use of the plasma separation device by direct transfer of blood from vein of human body in accordance to an embodiment of the present disclosure.
  • FIG.8 illustrates use of the plasma separation device when blood is drawn by a hypodermic syringe in accordance to an embodiment of the present disclosure.
  • FIG.9 illustrates an embodiment that can be used to get liquid plasma from finger prick blood in accordance to an embodiment of the present disclosure.
  • FIG.10 illustrates an embodiment with a large plasma separation device attached to an evacuated container in accordance to an embodiment of the present disclosure.
  • FIG.11 illustrates breaking a breakable portion of the container in accordance to an embodiment of the present disclosure.
  • FIG.12 illustrates storage of separated plasma in the evacuated container in accordance to an embodiment of the present disclosure.
  • FIG. 13 illustrates an embodiment of the plasma separation device configured with an additional barrier ring in accordance to an embodiment of the present disclosure.
  • light be included or have a characteristic, that particular component or feature is not required to be included or have the characteristic.
  • the present disclosure relates to separation of plasma/serum from whole blood, and more particularly, to devices and methods that allow extraction of plasma from whole blood directly into a tube/container.
  • FIGs. lA, IB, 2, 3, 4 and 5 illustrate embodiment 1 of the present invention.
  • FIG. 1A illustrates a completely assembled device. This device is useful for obtaining liquid plasma from whole blood at the point of care in the form of droplets.
  • FIG. IB illustrates the completely assembled device dispensing separated plasma in the form of a drop 61, and the drop 61 of the separated plasma being collected in a capillary, which can be a fixed volume capacity capillary 62 with a compressible bulb 63.
  • the plasma collected in the fixed volume capacity capillary 62 can be dispensed in a test device for quantitative analysis that requires an exact amount of plasma.
  • the bulb 63 attached to the capillary 62 can be used to create negative pressure to suck the drop 61 in the capillary 62, and later to dispense the plasma from the capillary 62 to the test device under positive pressure.
  • FIG. 2 illustrates a partially assembled device.
  • the device can include a body
  • the nozzle 31 can be of defined shape and size to deliver liquid droplets of specified volume.
  • a portion of the space inside of the device 30 has three Zones as described in summary of the invention.
  • Thefirst zone39 can contain large pore membrane and layers of agglutinating agent.
  • the second Zone38 contains one or more layers of large pore membranes treated to maintain hydrophobic/hydrophilic balance to retard the liquid flow.
  • the third zone37 which is a small pore filter matrix, also acts as a reservoir for the separated plasma.
  • the membranes in the three zones can be retained in position by a press fitted ring 36, which can be designed to be a flow director for the whole blood applied to the device in the sample reservoir34.
  • the inlet port 32 can be fitted with a plunger, pump or a compressible bulb to apply positive pressure.
  • FIGs. 3 and 4 illustrate a pressure generating attachment, which can befitted on inlet port 32 of the device 30 after the blood has been applied to the sample reservoir 34.
  • This attachment incorporates a compressible bulb 11 and a plunger portion 12 with a rim so that it can rest on the edge of device 30 and limit its movement into the sample reservoir 34.
  • the plunger contains a central hole 10 through which pressure is applied. It also contains a slot 40, which allows air to escape so that pressure is not applied during assembly of the attachment with the device 30, but only when the compressible bulb 11 is pressed.
  • FIG. 5 shows the device with built-in stand to make the device stand upright on legs 35.
  • the device 30 can be made to stand upright and blood applied through opening 32 into the sample reservoir 34.
  • the blood is directed to 39, the first zone, through the flow director 36 and plasma starts to separate as it travels through Zones 1 and 2.
  • plasma is collected in 37, third zone. Attachment of FIG.3 is then inserted in space 34 fully.
  • compressible bulb 11 is pressed to drive the plasma out of the reservoir 37 through nozzle 31 in the form of droplets of defined volume.
  • the extracted plasma may also be collected by a fixed volume capacity capillary tube connected to a compressible bulb and used for quantitative analysis by pressing the bulb to eject exact amount of plasma picked up by the capillary.
  • FIGs. 6, 7, 8, 9, 10, 11 and 12 illustrate embodiment 2 which is useful with evacuated containers.
  • Patient blood is generally collected in evacuated containers (tubes) also known as "Vacutainers" directly from patient vein or it is collected by syringe and then transferred to standard evacuated containers for centrifugation.
  • the blood is transferred to central labs where centrifugation is done and the plasma is removed from the tubes and transferred to other tubes with patient identification. These tubes are then fed into racks of automated analyzers.
  • Embodiment 2 eliminates the need for centrifugation. It also eliminates the need for two containers and transfer of sample from one to another making the process very simple.
  • FIG. 6 shows a fully assembled device. It consists of device 30, with an elastomeric cap 52 and a cover 53, which is connected to a container 50 in a leak-tight manner through seal 51.
  • Container 50 is made in such a manner that its rim 56 can be detached from the main body by applying a small tilting force.
  • the entire assembly is evacuated and the vacuum can be held for long periods, typically for 2 years or as necessary for the application, by elastomeric cap 52 which is held in position by cover 53.
  • Cover 53 has an opening 54 to allow access to elastomer 52 for puncturing with a needle to transfer the blood into space 34 of device 30.
  • FIG. 7 shows the use of the device by direct transfer of blood from the vein using a needle to puncture the elastomer 52.
  • FIG. 8 shows the use of the device when blood is drawn by a hypodermic syringe and it is transferred into the space 34 of device 30 by the syringe itself.
  • FIG. 9 shows an embodiment that can be used to get liquid plasma from the finger prick blood.
  • the size of the device is much smaller and the attachment 55 collects the small amount of blood and transfers it to the device for separation of plasma.
  • FIG. 10 shows an embodiment with a large device attached to the evacuated container which allows larger quantity of plasma to be obtained while the container can be of standard size.
  • the completely assembled device as shown in FIG. 6 is received in an evacuated condition much like the "Vacutainer".
  • Patient identification is made on the device tube (container portion of complete device) and whole blood is applied through opening 54 by piercing elastomer cap 52 with a needle coming from the transfer needle assembly directly from the patient arm or the needle of the syringe used to take blood from the arm.
  • the blood collects in space 34 of the device and is directed to the plasma separation Zones by the flow director. Due to the vacuum in the container, the blood starts travelling through the filter Zones 39 and 38 to reservoir 37. As the reservoir fills up the separated plasma starts making droplets which get collected in the evacuated tube.
  • the device 30 is removed by simply breaking the breakable portion of container 50 by applying small force by hand as shown in FIG. 11. A fresh cap is placed on the tube to seal the tube and the tube can be placed in the racks of automated analyzers. Since there is no transfer of the plasma from one tube to another there is no need to change the patient identification on the tube.
  • FIG. 12 illustrates storage of separated plasma in the evacuated container.
  • FIG. 13 illustrates embodiment 3 of the present invention.
  • the filter matrix that stops the RBC and allows plasma to travel through has a certain capacity of blood volume that the device can take before it will become overloaded and blood will start to either hemolyse or leak the RBC into the plasma. This is not acceptable as the results of the test can become invalid. It is thus necessary to either apply whole blood in a measured volume range or develop a method of locking the RBC or hemolysis from happening even if excessive amount of blood is applied.
  • FIG. 13 shows an embodiment of the invented device with an additional barrier ring 40 placed in the sample reservoir34 such that it divides the sample reservoir34 into an upper chamber42 and a lower chamber43.
  • the barrier ring has a membrane 41 which is hydrophobic with a low breakthrough pressure for blood. Breakthrough pressure is the pressure below which blood will not pass through the membrane but when the pressure exceeds a predefined value (determined by membrane characteristics) blood will pass through and continue to pass after that even if the pressure is reduced.
  • the upper chamber42 is designed to be equal to volume of blood sample to be applied to the filtering matrix. Since upper chamber42 is at vacuum initially, when blood is applied by syringe or directly from the vein of the body, it fills up quickly without going through the barrier membrane. As the upper chamber42 fills up, vacuum in the upper chamber42 goes down. When additional pressure is applied to upper chamber42 by syringe or any other means blood will break through the barrier membrane and move to the lower chamber43 and deliver plasma in the tube.
  • the present disclosure provides a single pre-assembled plasma separation device for extracting plasma/serum for blood.
  • the present disclosure provides a plasma separation device that reliably separate plasma/serum from whole blood within a few minutes without hemolysis of cells.
  • the present disclosure provides a plasma separation device for direct extraction of plasma from whole blood in a tube/container.
  • the present disclosure provides a plasma separation device that minimizes sample volume of blood required to extract a desired quantity of plasma.
  • the present disclosure provides a plasma separation device that generates a precise volume of plasma for quantitative analysis.
  • the present disclosure provides a plasma separation device that enables dispensing separated plasma in the form of a drop by a fixed volume capacity capillary.
  • the present disclosure provides a plasma separation device that can be applied for point-of-care use without the use of any expensive or bulky equipment.
  • the present disclosure provides a plasma separation device that is cost- efficient and easy-to-use.
  • the present disclosure provides a plasma separation device that is portable.
  • the present disclosure provides a plasma separation device that is compatible with vacuum based blood collection devices and provides plasma directly in a tube/container.
  • the present disclosure provides a plasma separation device that can accept blood by a syringe or from a vein of human body.
  • the present disclosure provides a plasma separation device that can be used with finger prick blood.
  • the present disclosure provides a plasma separation device with minimum number of elastomeric seals to prevent leakage of vacuum on long term storage.
  • the present disclosure provides a plasma separation device that is compatible with workflow of high throughput automatic analyzers.

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Hematology (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • General Health & Medical Sciences (AREA)
  • Physics & Mathematics (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Molecular Biology (AREA)
  • Biophysics (AREA)
  • Pathology (AREA)
  • Surgery (AREA)
  • Medical Informatics (AREA)
  • Chemical & Material Sciences (AREA)
  • Vascular Medicine (AREA)
  • Anesthesiology (AREA)
  • Analytical Chemistry (AREA)
  • Medicinal Chemistry (AREA)
  • Food Science & Technology (AREA)
  • Biochemistry (AREA)
  • Urology & Nephrology (AREA)
  • Ecology (AREA)
  • Cardiology (AREA)
  • Immunology (AREA)
  • General Physics & Mathematics (AREA)
  • Clinical Laboratory Science (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Investigating Or Analysing Biological Materials (AREA)

Abstract

L'invention concerne un dispositif pour séparer le plasma d'un échantillon de sang, qui permet l'extraction de plasma à partir de sang total directement dans un tube/récipient ou un capillaire de volume fixe. Le dispositif de séparation de plasma est constitué par un empilement de membrane (39, 38 et 37), un directeur d'écoulement (36) espacé au-dessus de l'empilement de membranes pour diriger l'écoulement de l'échantillon sur la membrane, un réservoir d'échantillon (34) pour recevoir et maintenir un échantillon de sang et espacée verticalement au-dessus de l'empilement de membrane, une entrée pour introduire un échantillon dans le réservoir d'échantillon et une sortie pour extraire le plasma séparé espacée verticalement en dessous de l'empilement de membrane. L'empilement de membrane comprend au moins une première zone (39), une deuxième zone (38) et une troisième zone (37) en séquence de haut en bas. La troisième zone (37) est une matrice de filtre à petits pores qui sert également de réservoir pour le plasma séparé.
PCT/IB2018/055594 2017-07-31 2018-07-26 Dispositif de séparation de plasma WO2019025914A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
IN201711027174 2017-07-31
IN201711027174 2017-07-31

Publications (1)

Publication Number Publication Date
WO2019025914A1 true WO2019025914A1 (fr) 2019-02-07

Family

ID=65232487

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/IB2018/055594 WO2019025914A1 (fr) 2017-07-31 2018-07-26 Dispositif de séparation de plasma

Country Status (1)

Country Link
WO (1) WO2019025914A1 (fr)

Cited By (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2020160616A1 (fr) * 2019-02-07 2020-08-13 Monash University Système capillaire destiné à un dispositif de séparation de sang
US20210396634A1 (en) * 2019-03-25 2021-12-23 Fujifilm Corporation Biological specimen separation instrument
CN114018835A (zh) * 2021-09-22 2022-02-08 浙江大学 微量全血预处理和血浆自动定量分配装置及分析方法
EP4310511A4 (fr) * 2020-09-23 2024-07-10 Provigate Inc Dispositif de traitement d'échantillons liquides

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20080210644A1 (en) * 2004-08-05 2008-09-04 David Milunic Blood Separator and Method of Separating a Fluid Fraction from Whole Blood
US20100042038A1 (en) * 2008-08-12 2010-02-18 Caridianbct, Inc. System and Method for Collecting Plasma Protein Fractions from Separated Blood Components
US20140263059A1 (en) * 2013-03-14 2014-09-18 Lawrence J. Burg Plasma separation from blood using a filtration device and methods thereof
WO2016073415A2 (fr) * 2014-11-04 2016-05-12 Wainamics, Inc. Séparateur de plasma à l'échelle microscopique

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20080210644A1 (en) * 2004-08-05 2008-09-04 David Milunic Blood Separator and Method of Separating a Fluid Fraction from Whole Blood
US20100042038A1 (en) * 2008-08-12 2010-02-18 Caridianbct, Inc. System and Method for Collecting Plasma Protein Fractions from Separated Blood Components
US20140263059A1 (en) * 2013-03-14 2014-09-18 Lawrence J. Burg Plasma separation from blood using a filtration device and methods thereof
WO2016073415A2 (fr) * 2014-11-04 2016-05-12 Wainamics, Inc. Séparateur de plasma à l'échelle microscopique

Cited By (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2020160616A1 (fr) * 2019-02-07 2020-08-13 Monash University Système capillaire destiné à un dispositif de séparation de sang
US20210396634A1 (en) * 2019-03-25 2021-12-23 Fujifilm Corporation Biological specimen separation instrument
EP4310511A4 (fr) * 2020-09-23 2024-07-10 Provigate Inc Dispositif de traitement d'échantillons liquides
CN114018835A (zh) * 2021-09-22 2022-02-08 浙江大学 微量全血预处理和血浆自动定量分配装置及分析方法

Similar Documents

Publication Publication Date Title
JP7502486B2 (ja) 生物体液の極微標本管理装置
WO2019025914A1 (fr) Dispositif de séparation de plasma
CN110740812B (zh) 生物流体分离装置
US11650200B2 (en) Device for whole blood separation
US20100093551A1 (en) Liquid Transfer and Filter System
EP2788755B1 (fr) Système de détection d'hémolyse
US5275731A (en) Apparatus for rapidly separating blood into filtered fractions
EP3411709B1 (fr) Agencement de collecte et de séparation d'un fluide corporel à des fins d'analyse et procédé associé
US5195534A (en) Biological fluid collection and dispensing apparatus and method
US6039868A (en) Blood separator system
CA3102269C (fr) Dispositif de separation de fluide biologique

Legal Events

Date Code Title Description
121 Ep: the epo has been informed by wipo that ep was designated in this application

Ref document number: 18841675

Country of ref document: EP

Kind code of ref document: A1

NENP Non-entry into the national phase

Ref country code: DE

122 Ep: pct application non-entry in european phase

Ref document number: 18841675

Country of ref document: EP

Kind code of ref document: A1