WO2014031253A1 - Dispositif et procédé de réalisation de dosages sanguins par thromboélastographie par détection magnétique - Google Patents
Dispositif et procédé de réalisation de dosages sanguins par thromboélastographie par détection magnétique Download PDFInfo
- Publication number
- WO2014031253A1 WO2014031253A1 PCT/US2013/050670 US2013050670W WO2014031253A1 WO 2014031253 A1 WO2014031253 A1 WO 2014031253A1 US 2013050670 W US2013050670 W US 2013050670W WO 2014031253 A1 WO2014031253 A1 WO 2014031253A1
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- WIPO (PCT)
- Prior art keywords
- thromboelastography
- whole blood
- msed
- elastometry
- reagent
- Prior art date
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Classifications
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- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N11/00—Investigating flow properties of materials, e.g. viscosity, plasticity; Analysing materials by determining flow properties
- G01N11/10—Investigating flow properties of materials, e.g. viscosity, plasticity; Analysing materials by determining flow properties by moving a body within the material
- G01N11/14—Investigating flow properties of materials, e.g. viscosity, plasticity; Analysing materials by determining flow properties by moving a body within the material by using rotary bodies, e.g. vane
Definitions
- the present invention relates generally to the blood thromboelastographic assay. More specifically, the present invention is a convenient device and method for performing whole blood thromboelastographic assay by magnetic sensing to test blood clot formation, retraction and/or lyses process.
- thromboelastography An accurate assessment of the efficiency of blood coagulation (thromboelastography) is very important for treating hemorrhage, trauma, as well as for various anesthetic and surgical procedures.
- Coagulation is the process whereby blood forms clots.
- Blood coagulation i.e.,
- thrombogenesis is a result of a series of biochemical reactions through primary hemostasis and secondary hemostasis. Briefly, primary hemostasis involves platelets adhesion and aggregation; secondary hemostasis involves plasma factors reacting with each other and fibrinogen being converted into cross-linked polymeric fibrin through several enzymatic reactions. Blood coagulation is the cessation of blood loss from a damaged vessel, wherein a damaged blood vessel wall is covered by a platelet and fibrin-containing clot to stop bleeding and begin the repair of damaged vessel. Disorders of this coagulation can lead to an increased risk of bleeding (hemorrhage) or obstructive clotting (thrombosis).
- the coagulation usually begins almost instantly after an injury to the blood vessel has damaged the endothelium lining the vessel. Exposure of the damaged vessel wall to the bare tissue in the wound led to initiation of coagulation by tissue factor expressed as an integral membrane protein. Tissue factor binds to plasma factor Vila initiates enzymatic reactions of procoagulant plasma proteins that lead to the formation of thrombin resulting in platelet activation and subsequent assembly of procoagulant complexes on the platelet surface leading to the conversion of fibrinogen to cross-linked fibrin clots which strengthen the platelet plug.
- This coagulation cascade is regulated tightly by various endogenous anticoagulants that act at different steps in the pathway to maintain the balance between clotting and bleeding.
- Coagulopathy associated with severe injury complicates the control of bleeding and is linked to the increased morbidity and mortality in trauma patients. Rapid diagnosis and directed interventions may reduce preventable deaths after severe injury.
- the causes of coagulopathy in patients with severe trauma are multifactorial, including consumption and dilution of platelets and coagulation factors, as well as dysfunctions of platelets and the coagulation system. Hypothermia, acidosis, and dilution from standard resuscitation can worsen the presenting coagulopathy and perpetuate bleeding.
- Strategies to prevent significant coagulopathy and to effectively control critical bleeding in the presence of coagulopathy may reduce the requirement for blood transfusion, thereby improving clinical outcome of patients with major trauma.
- hemorrhage in traumatized casualties remains the major cause of death in combats.
- a rugged device to assess overall hemostasis function in forward combat areas is thus strongly desired.
- perioperative diagnosis and monitoring of blood coagulation is critical to better understand the causes of hemorrhage, to guide hemostatic therapies, and to predict the risk of bleeding during the consecutive anesthetic or surgical procedures.
- a timely informed blood coagulation assessment is critically needed in determining patient susceptibility to postoperative thrombotic complications or as indicator of early sepsis, particularly regarding the use of blood products and guiding treatment with haemostatic components .
- thromboelastography usually a small sample of blood (typically 0.36 ml) is placed into a cuvette that is rotated gently through 4° 45' (cycle time 6 min) to imitate sluggish venous flow and activate coagulation.
- a sensor When a sensor is inserted into the sample, a clot will form between the cuvette and the sensor.
- the speed and strength of the clot formation can be measured in various ways; and are dependent on the activity of the plasmatic coagulation system, platelet function, fibrinolysis and other factors which may be affected by illness, environment and medications. If there is suspicion that the blood has difficulty to clot due to either medication or disease, the blood sample would be exposed to a clot-inducing agent (such as kaolin) immediately prior to the test.
- a clot-inducing agent such as kaolin
- the first thromboelastography method was introduced by Hartert in 1948 and certain modifications have been made over the years to improve the technique.
- Hartert introduced a cylindrical member rigidly mounted in the solid frame and a beaker mounted on the upper end of a rod- like support that is mounted onto the solid frame by means of a circular resilient diaphragm.
- a coil arrangement at the lower end of the rod produces a rotating electro-magnet field and imparts to the rod an orbital movement.
- a further core above the diaphragm is used as the pick-up device to record trace of the change in amplitude of the elastic support upon clot formation. This allows more detailed and accurate recording of the clot formation process.
- Haemoscope Corporation further improves the technique and includes a torque sensing column and a drive ring disposed around a body of the column.
- the apparatus further includes a first guide shaft rigidly secured to the drive ring and a cup holder. This invention led to the current Haemoscope TEG device.
- Sonoclot Analyzer (Sienco Inc., Arvada, CO) uses a hollow, open- ended disposable plastic probe mounted on a transducer head where the probe oscillates vertically during testing. The changes in impedance to movement imposed by the developing clot are recorded.
- Sonoclot test trace has been considered as rather qualitative in its clinical applications.
- the maximal clot firmness of these techniques is about 50 to 70 mm.
- a general sensitivity level is about 2 mm, higher test-to-test variations are almost unavoidable. This is a serious problem, especially in the case of measuring samples in thrombocyte inhibited tests for fibrinogen abnormality.
- FIG. 1 depicts a preferred embodiment of the present invention with an exploded view of the detection sub-assembly.
- FIG. 2 depicts an embodiment of a sample cuvette.
- FIG. 3 depicts an embodiment of a disposable detecting head.
- FIG. 4 depicts an embodiment of a coupling/receiving cavity.
- FIG. 5 depicts an embodiment of a rotating disc.
- FIG. 6 depicts an embodiment of a stepper-based electro-mechanical rotary magnetic field generator.
- FIG. 7 depicts an embodiment of a static coils-based electro-mechanical rotary magnetic field generator.
- FIG. 8 is an isometric view of the present invention.
- FIG. 9 is a block diagram of the basic system and dedicated electronics.
- FIG. 10 is a waveform chart demonstrating the detection front-end basic timing.
- FIG. 11 is a typical trace of thromboelastograph for "TEG Level- 1".
- FIG. 12 is a typical trace of thromboelastograph for "TEG Level-2”.
- FIG. 13 is a typical trace of thromboelastograph for normal human whole blood.
- FIG. 14 is a typical trace of thromboelastograph for abnormal human whole blood.
- the present invention relates to a device and method for performing whole blood thromboelastography assays. It is also related to a portable device that is easy to use, accurate, and quick for testing a patient's blood at bedside, physician's office, operating room, or even in battle field.
- the present invention a Magnetic Sensor Elastometry Device (MSED), measures the viscoelasticity properties of whole blood.
- MSED Magnetic Sensor Elastometry Device
- the deforming shear stress initiated by the rotating disc immersed in the test blood sample is detected and measured at its own body (at the rotating disc).
- the present invention comprises a sample cuvette sitting in a sample holder heated by a heated block to provide constant temperature at 37°C, a rotating disc and a disposable detecting head coupled by a docking cavity, a magnetic field generator providing means for the rotating disc, a disc shaft and a shaft locking pin to secure the disc, a crystal timer and an optical motion detector together with optical amplifier and signal gating circuit.
- a disposable sensing head made of a plastic spring-like wing, is inserted into a detection rotating disc through a coupling cavity.
- a reagent is added to trigger the hemostasis process.
- a proprietary microcontroller and its embedded firmware perform the functions of driving the rotating magnetic disc back and forth at a
- an embodiment of the present invention consists of a sample cuvette 101, a disposable detecting head 102, a sensing disc coupling and receiving cavity 103, a sensing disc 104, a magnetic field generator 902, including stepper-based electro-mechanical rotary magnetic field generator 601, and static coils-based electro-mechanical rotary magnetic field generator 701.
- FIG 1 is an exploded view of the detection sub-assembly, including: (1) cuvette 101 (to hold the blood sample under test), (2) detection head 102, (3) sensing disc coupling and receiving cavity 103, (4) rotating disc 104, (5) disc shaft 105, (6) shaft locking pin 106, (7) optical motion detector 107, (8) optical amplifier and signal gating circuit 108, (9) heated block 109 to provide constant temperature at 37 °C, (10) electro-mechanical rotary magnetic field generator 601 and 701, and (11) block heater 110.
- the viscoelasticity of blood hemostasis may be measured by placing a disposable detector head 102 in contact with the whole blood sample 901 placed in a sample cuvette 101.
- the blood's temperature is maintained at 37 °C with the aid of a computer controlled heated sampling bay.
- the detector head 102 is temporarily attached to the magnetic rotating disc 104 via a coupling mechanism of the coupling and receiving cavity 103.
- the disc is then moved by the magnetic rotating field underneath the cuvette holding unit. Initially, the detection head/rotating disc assembly follows instantly, with no perceptible delay, the magnetic rotary motion.
- This device uses the combination of a cylindrical cup and a matching shear-inducing disc, and uses an optical gating assembly allowing accurate signal collection following the viscoelasticity changes upon blood clot formation.
- the system uses a new and unique approach to detect the viscoelasticity characteristics of the testing sample. This novel method exploits the electro-mechanical motion parameters and the physical changes of the whole blood sample following the addition of a reagent.
- the high-speed pulse generator is running (FIG. 10-A)
- the system microcontroller 906 energizes the magnetic power drivers 908 which produce incremental rotational movement of the disc 104 and detector-head 102 (FIG. 10-B).
- the disc 104 has an angular rotation range of 45 degrees comprising a number of angular motions equally spaced (for example, 3 equal angular motions of 15 degrees each; or 6 equal angular motions of 7.5 degrees each).
- the microcontroller 906 enables the first stage of the pulse-gating logic (FIG. 10-C), permitting the high-speed pulses to pass through.
- the optical motion detector 107 monitors the rotating disc 104.
- the amplified output enables or disables the second gate (FIG. 10-D) of the high-speed pulses; which will be read by the microcontroller 906 (FIG. 10-E).
- the motion detector 107 will produce a "time window" directly proportional to the speed at which the disc 104 is rotating and the time delayed response of the disc. Therefore, right at the moment when the reagent is added to the whole blood sample 901, the liquid mixture exhibits the lowest viscoelasticity values; and the response of the disc 104 is almost instantaneous with no perceptible time delay.
- the "gated time window” is very short, permitting only a small number of high-speed pulses generated by high-speed pulse generator 904 to pass through. As time goes by, the viscoelasticity of the testing sample changes; and this forces the disc 104 to slow down its rotational speed and starts causing time response delays.
- the first gated time window is enabled by the microcontroller 906; and the second gated time window is controlled by a rotating angular speed of the rotating disc 104.
- the "gated time window" becomes longer, and allows larger number of pulses to pass through.
- Several default conditions were setup when this invention was reduced to practice, including the frequency of the high-speed pulse generator 904, the width of the slots on the rotating disc 104, the angle and width of the optical beam, the time allotted to the microcontroller 906 to read the incoming pulses, and the optimal rotational magnetic speed which was set as 1,875 milliseconds per incremental angular move.
- a thromboelastography reagent is used for causing controlled viscoelasticity changes of the blood sample held in the sample cuvette 101.
- the reagent is calcium chloride, either a lyophilized reagent or an air-dried reagent.
- the thromboelastography reagent may also include kaolin, tissue factor, heparinase, platelet inhibitor, or aprotinin.
- the processing electronic components are shown in the system block diagram (FIG. 9) as follows: a power supply, fed by an external AC to DC power adapter and equipped with voltage regulators and distribution 911; an optical motion detector 107 ; an optical amplifier and signal gating 108; a high-speed pulse generator 904; a pulse-gating logic 905; a heater's power driver 907; a block heater 110; a set of magnetic power drivers 908; a microcontroller's clock generator 912; an 8-bit CMOS enhanced flash-based system microcontroller 906; a serial communications port 913; a 12V DC input jack 909; a user interface 914 comprising an ON/OFF power switch 910, an LCD screen, a audible beeper and a keypad.
- a full system may also include an external or internal computer.
- the system microcontroller 906 When the device is powered up, the system microcontroller 906 will perform the following actions in order: 1) Immediate disable of all power drivers, for safety and minimizing power consumption; 2) User interface initialization: LCD, beeper and keypad; 3) Display startup message; 4) Internal self-test for firmware integrity; 5) Display self-test results if any errors are found and wait for operator's acknowledge; 6) Display welcome message and firmware version number; 7) Wait for operator's input; 8) Monitor cuvette bay (heated block) for proper operating temperature; 9) Monitor communications port; 10) Display "System Ready” prompt when a predetermined test temperature is reached; 11) Wait for operator's input command(s); 12) Guide operator through the test procedure via LCD messages; 13) Monitor Detection Arm position; 14) Run thromboelastometry test; 15) Acquire and transmit sensor raw data via serial communications port; 16) Calculate, store and display results; and 17) Wait for operator's input.
- the whole blood sample volume is 260 micro-liters along with 40 micro-liters of the reagent.
- the whole blood thromboelastometry test is performed following these steps: 1) The device is powered-on; 2) Welcome message and firmware version number are displayed on the LCD; 3) The system running an auto self-test; 4) Checking the testing bay (cuvette heating block) for the correct temperature; 5) Once the temperature is reached, the 'ready' message being displayed; 6) The system instructing the operator to lift the detection arm; 7) Promoting to insert a disposable detecting head; 8) Placing a cuvette in the testing bay; 9) Instructing to deliver the whole blood sample into the cuvette; 10) Waiting for the blood sample to reach the proper test temperature; 11) Once the sample reaches 37 °C, the operator being instructed to deliver the reagent; 12) Starting test and data being collected and sent to main computer; 13) The MSED device displaying a message to indicate the test has ended; 14) The raw data received by the computer
- the present invention has advantages over the existing techniques with its higher signal-to- noise ratio and higher precision. It is also sturdy and durable as compared with those wire-cup and pin-cup devices, as well as provides a broader testing range. Further, it has eliminated certain problems associated with previous devices by measuring the changes in blood elastic and viscous properties using an optically-gated time-domain window, which practically has no inherent noise.
- the present invention utilizes a sensor comprising a detector head and rotating disc subassembly.
- the rotational motions could be limited to predetermined angular displacement not completing a full revolution range.
- the monitoring optical window can also be achieved by other technology means, such as digital encoding, angular reflectometry, full motion picture comparative analysis, etc.
- Other embodiments may combine the capabilities of both microcontroller and internal or external computer into either a microcontroller or a computer, making it unnecessary of the use of both.
- microcontroller's firmware has (in addition to running the actual biological test) the task of guiding the operator/user through each of the steps necessary to perform the complete process of whole blood testing and handle the user's response/input. It is also possible to eliminate all those in favor of a fully automated and optimized "one key press" process.
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Abstract
L'invention concerne un dispositif d'élastométrie à détecteur magnétique (MSED) et un procédé de réalisation d'un dosage par thromboélastographie de sang complet. Il contient des éléments clefs, comprenant une cuvette à échantillons, une tête de détection, un disque rotatif, un détecteur de mouvement optique, etc. ; et mesure la viscoélasticité des échantillons de sang complet. Le dispositif surveille optiquement le mouvement physique du disque rotatif entraîné magnétiquement, immergé dans l'échantillon de sang. Le thromboélastographe est enregistré par le détecteur de mouvement optique lisant des coups de hautes impulsions, passant à travers le disque rotatif, via une fenêtre temporelle à porte. Le dispositif comporte également un microcontrôleur et son microprogramme intégré pour réaliser les fonctions d'entraînement du disque magnétique rotatif, de génération d'impulsions à hautes fréquences, de commande de la fenêtre temporelle d'impulsions de données, ainsi que de maniement de l'interface utilisateur, d'analyse des données et de maintien de la communication avec un ordinateur externe.
Priority Applications (3)
Application Number | Priority Date | Filing Date | Title |
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CN201380044224.6A CN104981477A (zh) | 2012-08-22 | 2013-07-16 | 用于通过磁感测执行血液凝血弹性描记测定的设备和方法 |
EP13831497.6A EP2888274A4 (fr) | 2012-08-22 | 2013-07-16 | Dispositif et procédé de réalisation de dosages sanguins par thromboélastographie par détection magnétique |
US13/944,616 US9546981B2 (en) | 2012-08-22 | 2013-07-17 | Device and method for performing blood thromboelastographic assays by magnetic sensing |
Applications Claiming Priority (2)
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US201261692141P | 2012-08-22 | 2012-08-22 | |
US61/692,141 | 2012-08-22 |
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US13/944,616 Continuation-In-Part US9546981B2 (en) | 2012-08-22 | 2013-07-17 | Device and method for performing blood thromboelastographic assays by magnetic sensing |
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WO2014031253A1 true WO2014031253A1 (fr) | 2014-02-27 |
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PCT/US2013/050670 WO2014031253A1 (fr) | 2012-08-22 | 2013-07-16 | Dispositif et procédé de réalisation de dosages sanguins par thromboélastographie par détection magnétique |
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EP (1) | EP2888274A4 (fr) |
CN (1) | CN104981477A (fr) |
WO (1) | WO2014031253A1 (fr) |
Cited By (7)
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WO2016200765A1 (fr) * | 2015-06-08 | 2016-12-15 | The Regents Of The University Of Colorado, A Body Corporate | Paramètre d'analyse viscoélastique indépendant du temps pour la prédiction de résultat de patient |
CN106771108A (zh) * | 2016-12-29 | 2017-05-31 | 山东朗伯光谱设备有限公司 | 一种自动获取血栓弹力图的方法及装置 |
CN108020657A (zh) * | 2018-01-18 | 2018-05-11 | 中实医疗科技江苏有限公司 | 血栓弹力图检测装置 |
WO2020200046A1 (fr) * | 2019-03-29 | 2020-10-08 | 赫安仕科技(苏州)有限公司 | Dispositif de test de thromboélastographie entièrement automatique et procédé de test |
US11137409B2 (en) | 2014-11-06 | 2021-10-05 | The Regents Of The University Of Colorado, A Body Corporate | Identification of novel disease states using viscoelastic analysis in the presence of a thrombolytic agent |
US11169142B2 (en) | 2016-05-11 | 2021-11-09 | The Regents Of The University Of Colorado, A Body Corporate | Viscoelastic analysis in patients with disease associated with cardiovascular system |
CN117740681A (zh) * | 2024-02-19 | 2024-03-22 | 煤炭科学研究总院有限公司 | 观察磁性液体微观结构的检测装置 |
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KR102516995B1 (ko) * | 2016-04-05 | 2023-03-31 | 제네럴 일렉트릭 컴퍼니 | 조정가능한 성장 인자 레벨을 가진 활성화된 혈소판 조성 |
EP3574321A1 (fr) | 2017-01-26 | 2019-12-04 | enicor GmbH | Dispositifs et procédés de mesure de changements viscoélastiques d'un échantillon |
CN107976382B (zh) * | 2018-01-12 | 2024-02-13 | 宝锐生物科技泰州有限公司 | 检测探头及血样检测装置 |
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CN108508192A (zh) * | 2018-04-03 | 2018-09-07 | 江苏锐汗德医疗科技有限公司 | 一种血栓弹力图检测组件及检测仪 |
CN110208511B (zh) * | 2019-07-11 | 2024-03-08 | 北京森美希克玛生物科技有限公司 | 弹力图仪和可视化弹力图设备 |
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US11137409B2 (en) | 2014-11-06 | 2021-10-05 | The Regents Of The University Of Colorado, A Body Corporate | Identification of novel disease states using viscoelastic analysis in the presence of a thrombolytic agent |
WO2016200765A1 (fr) * | 2015-06-08 | 2016-12-15 | The Regents Of The University Of Colorado, A Body Corporate | Paramètre d'analyse viscoélastique indépendant du temps pour la prédiction de résultat de patient |
US11187710B2 (en) | 2015-06-08 | 2021-11-30 | The Regents Of The University Of Colorado, A Body Corporate | Time independent viscoelastic analysis parameter for prediction of patient outcome |
US11169142B2 (en) | 2016-05-11 | 2021-11-09 | The Regents Of The University Of Colorado, A Body Corporate | Viscoelastic analysis in patients with disease associated with cardiovascular system |
CN106771108A (zh) * | 2016-12-29 | 2017-05-31 | 山东朗伯光谱设备有限公司 | 一种自动获取血栓弹力图的方法及装置 |
CN106771108B (zh) * | 2016-12-29 | 2023-06-02 | 山东朗伯光谱设备有限公司 | 一种自动获取血栓弹力图的方法及装置 |
CN108020657A (zh) * | 2018-01-18 | 2018-05-11 | 中实医疗科技江苏有限公司 | 血栓弹力图检测装置 |
CN108020657B (zh) * | 2018-01-18 | 2024-05-07 | 中实医疗科技江苏有限公司 | 血栓弹力图检测装置 |
WO2020200046A1 (fr) * | 2019-03-29 | 2020-10-08 | 赫安仕科技(苏州)有限公司 | Dispositif de test de thromboélastographie entièrement automatique et procédé de test |
CN117740681A (zh) * | 2024-02-19 | 2024-03-22 | 煤炭科学研究总院有限公司 | 观察磁性液体微观结构的检测装置 |
CN117740681B (zh) * | 2024-02-19 | 2024-05-14 | 煤炭科学研究总院有限公司 | 观察磁性液体微观结构的检测装置 |
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CN104981477A (zh) | 2015-10-14 |
EP2888274A4 (fr) | 2016-03-16 |
EP2888274A1 (fr) | 2015-07-01 |
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