CN203825014U - Test box for sample testing - Google Patents

Test box for sample testing Download PDF

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Publication number
CN203825014U
CN203825014U CN201420171272.3U CN201420171272U CN203825014U CN 203825014 U CN203825014 U CN 203825014U CN 201420171272 U CN201420171272 U CN 201420171272U CN 203825014 U CN203825014 U CN 203825014U
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China
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sample
testing
testing cassete
holding structure
described sample
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CN201420171272.3U
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Chinese (zh)
Inventor
P·德尔梅尼科
C·G·洛佩兹-艾斯皮纳
G·拉维夫
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Haemoscope Corp
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Haemoscope Corp
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Abstract

The utility model relates to a test box for sample testing. The test box can be used for executing various tests of viscoelastic samples, such as hemostatic testing of whole blood or blood constituent samples. The test box comprises a sample processing part in fluid communication with a sample retaining structure. A suspension part of a beam, an arm part, a cantilever or a similar structure is used for supporting or suspending the sample retaining part in an integrated structure form corresponding to the sample processing part. In such a manner, the sample retaining part can be put in dynamic excitation as responding to excitation to the test box and corresponding dynamic resonance excitation to a sample contained in the sample retaining part; meanwhile, the sample processing part is retained and fixed. The excited sample is observed and data indicating hemostasis are generated. The data can correspond to hemostatic parameters, such as initial blood clot formation time, blood clot formation rate, largest blood clot intensity and blood clot dissolution degree.

Description

For the testing cassete of test sample
Technical field
The utility model relates to hemostasis test, and this utility model is specifically related to the test sample box for preparing and test blood sample.
Background technology
When blood is liquid form when in body passage, interference-free is current.But damage may cause in the blood clotting fast of damage location place to tentatively stop blooding, and help agglutination subsequently.For some operation and medical procedure, it is vital that the coagulation ability timely and effectively to sufferer blood and dissolving power subsequently carry out accurately measuring.In addition, the accurate detection of abnormal hemostasis is particularly important for suitable treatment is provided for the sufferer of suffering from blood coagulation disorders.
Hemostasis is the result of the biochemical process of high complexity, and this process is converted to gel state by blood from liquid condition.The feature of blood, such as other mechanical attributes of clot intensity and blood, is useful in the time determining hemostasis feature.For example, if clot intensity can be resisted the shearing force of blood circulation, clot can be attached to damaged blood vessels position (vascular system of for example opening after operation) and stop blooding.The clot forming at not impaired (closed) vascular system place equally will hinder flowing of blood, and may cause that according to its position heart attack, ishemic stroke, pulmonary embolism (PE) or dvt form (DVT).
According to own together name be called " Method of Analyzing Hemostasis(analyze hemostasis method) " U.S. Patent No. 8,236,568; Name is called the No.7 of " Hemostasis Analyzer and Method(hemostasis analyzer and method) ", 879,615 and name be called the No.7 of " Hemostasis Analyzer and Method(hemostasis analyzer and method) ", 261,861, the disclosure of these applications is clearly incorporated to herein by reference at this, has described equipment and method for the resonance response of dynamic exciting being analyzed by observing sample hemostasis.According to the instruction of these patents, hemostasis analyzer operates based on following principle, because the hemostasis of blood sample is changed into gel state by blood sample from liquid condition, and by solidifying the natural frequency of viscoelastic property control sample of clot of formation, the natural frequency of the blood sample of therefore measuring in process of setting changes the haemostatic properties that blood sample is provided.According to this principle, hemostasis analyzer measure blood sample solidify with course of dissolution in natural frequency change, to the haemostatic properties of blood sample is provided.In order to measure by this way hemostasis, this analyzer generally includes container for keeping blood sample, inductor for the motional amplitude of the blood sample that makes vessel moving carry out the Vib. of synchronous vibration or driver with excitation blood sample and to be caused for measuring.
The patented method that above-mentioned hemostasis is analyzed provides the vibration for sample resonance.In the time that blood is converted to gel state from liquid condition, (such as the cross-linking system of obvious dilution, under stable state, do not flow), the natural frequency of blood sample increases.Therefore, solidify with course of dissolution in, measure the natural frequency of sample under incentive action and change hemostasis instruction being provided.
Utility model content
Can comprise the sample preparation part with fluid handling structure and the test sample part with sample holding structure for the testing cassete of test sample.Test sample part can be attached to sample by fluid passage and prepare part, and fluid passage provides the fluid between fluid handling structure and sample holding structure to be communicated with.Sample holding structure supports and treats tested sample, and sample can be energized to resonate in response to being applied to the excitation of testing cassete.Sample holding structure also allows the sample resonating to being energized to observe.
Testing cassete could be attached to sample and prepares part, makes described sample retaining part can be independent of described sample and prepares part and be separately energized.For example, sample holding structure can be attached to sample via the outstanding portion of connecing and prepare part.
Testing cassete can be the assembly of each parts.For example, testing cassete can be the laminar structure that comprises multiple independent layers that are linked together.
The fluid handling structure of testing cassete can comprise multiple fluid passages, at least one valve, corrugated tube and the reservoir operationally arranged.Reagent can be disposed in one or more and the multiple combination thereof in other parts of fluid passage, valve, corrugated tube, reservoir or fluid handling structure.
The valve arrangement of testing cassete can be the hydrophobicity ventilation interface being arranged in passage or other fluidic structures.Another valve arrangement can be the flexible membrane being arranged in passage.
Sample holding structure can be ring part.
Hemostasis method of testing can comprise: blood sample is introduced to fluid handling structure, and wherein fluid handling structure for example comprises reagent in passage.Fluid sample can flow through fluid handling structure by part to be processed with contact reagent.Then processed part is passed to the sample holding structure of fluid handling structure.Carry out vibrational excitation by the part to processed and obtain the data of at least one hemostasis parameter of instruction, thereby realize test.
Reagent can be disposed in the passage of fluid handling structure, and to process sample can be to make this part passage of flowing through.
Fluid handling structure can comprise the pump of processing the part in structure for pumping fluid.This pump can also be used for that sample pump is delivered to sample and keep equipment.
Fluid handling structure can comprise the first and second passages corresponding to the first and second tests or chemical examination.In this layout, can comprise the Part I of blood sample is passed through to first passage and the Part II of blood sample is passed through to second channel the processing of sample.Similarly, the first and second parts can be passed to the first and second sample holding structures.Can complete the test to multiple processed sample portion, for example, by the processed part of excitation or processed multiple parts, to realize resonance simultaneously.Sample excitation can realize by the testing cassete that comprises fluid handling structure and sample holding structure being applied to pumping signal or applying pumping signal by the part that comprises sample holding structure to testing cassete only.
The hemostasis data that generate can comprise the parameter of of at least indicating in option below: time, the clot that initial clot forms forms the clot dissolution degree that speed, maximum clot intensity and the schedule time after maximum clot intensity occurs locate, for example the clot dissolution degree 30 minutes time.Data can be by network delivery to other positions or processor.Data can also or alternatively be described with figure.
Accompanying drawing is described
Fig. 1 has described the testing cassete for test sample according to embodiment of the present utility model described herein with figure.
Fig. 2 is the schematic diagram of hemostasis analyzer, and the testing cassete of Fig. 1 can use in this hemostasis analyzer.
Fig. 3 has described the testing cassete for test sample according to alternative embodiment of the present utility model described herein with figure.
Fig. 4 is according to the front view of the sample contained structure of embodiment described herein.
Fig. 5 is the end-view of the sample contained structure shown in Fig. 4.
Fig. 6 is according to the front view of the sample contained structure of embodiment described herein.
Fig. 7 has described the testing cassete for test sample according to embodiment of the present utility model described herein with figure.
Embodiment
According to embodiment described herein, test sample box can be used for carrying out various tests such as the viscoelasticity sample of whole blood or blood component sample.This test sample box comprises sample process part, and this sample process part is communicated with sample holding structure fluid.In one embodiment, support with overall version with respect to sample process part or the outstanding sample retaining part that connects such as the outstanding portion that connects of beam, arm, cantilever or similar structures.Sample process part can be held in permission and pneumatic drive source and allow user interactions to be communicated with by rigidity, and sample retaining part can be placed in the dynamic exciting in response to the excitation of other parts of the sample retaining part of testing cassete, testing cassete or testing cassete as a whole.Correspondingly, as the result of this excitation, in sample retaining part, realized the dynamic resonance excitation of sample.Observe being energized sample, obtain the data of the resilient property of the change of instruction sample.These data can be corresponding to hemostasis parameter, and the time forming such as initial clot, clot form speed, maximum clot intensity, blood-clot lysis time and clot dissolution degree.
Fig. 1 has described test sample box 10 with figure, this test sample box comprise sample process part 12, sample retaining part 14 and structurally, sample retaining part 14 is connected on mechanics to the outstanding portion that connects of sample process part 12, for example beam 16.Allow sample retaining part 14 as the spring carried mass (sprung mass) with respect to sample process part 12 with the beam 16 shown in cantilevered construction, and allow to vibrate in response to imposing on the excitation of testing cassete 10.Also can use and can mechanically connect and allow simultaneously sample retaining part to carry out with respect to sample process part other structures that relative dynamic moves, such as spring, Multi-link suspension, rigidity or semi-rigid member and similar component.Should be understood that the less displacement that needs sample, that is, and vibration.In specific implementations, may directly connect sample process part 12 and sample retaining part 14, even make their members that forms as one.
Sample process part 12 comprises port one 8, and liquid sample 100 can be introduced into sample process part 12 via this port.Port one 8 can be self-packing (as barrier film or other automatic sealing mechanism), once sample is introduced in testing cassete 10, just not from testing cassete outflow, leakage, seepage etc.Port one 8 is communicated with the initial reservoir 20 that receives sample.Sample process part 12 also comprises: path, channel, refuse chamber, passage and similar structures 22; Corrugated tube or pump 24 and valve 26, move through sample process part 12 for controlling sample 100 or one partial response in the actuating of corrugated tube 24, to prepare the sample 100 for testing.
Aerodynamic force can be the vacuum of applied pressure, extraction or both combinations, and be vacuum in a preferred embodiment, this aerodynamic force can directly be used on sample 100, to moved in testing cassete 10 and the various parts of testing cassete 10 are handled.In the embodiment illustrating, the vacuum that is applied to central port 19 makes sample 100 be loaded on staging area 20, and further sample 100 is aspirated into corrugated tube 24.Sample 100 is pumped down to drain port 28, thereby allows only by the physical dimension of box, sample fluid volume to be carried out to careful control.Therefore, without the monitoring load time or without the volume of sample 100 being carried out to sensing initiatively, thereby structure and the operation of testing cassete 10 have been simplified.
Vacuum is applied to corrugated tube 24 and selected valve 26 is operated, this causes sample portion 100 to be aspirated and enter first passage 22 ' from staging area 20.First passage 22 ' can comprise and is liquid, gel, test agent cryodesiccated, dry or the form that other are applicable, when being sucked, sample portion 100 enters and during through passage 22 ', aforementioned test agent is recombinated by sample portion and mixed with sample portion subsequently.By repeatedly sample 100 being passed to first passage 22 ' and making it pass first passage 22 ', the circulation of corrugated tube 24 provides the mixing of sample and reagent.Control to valve 26 and the actuating of corrugated tube 24 is allowed to make condition sampling section 100 via second channel 22 " be passed to sample retaining part 14.
Be not restricted to and operate in two ways corrugated tube for operating sample portion 100 is transmitted through the corrugated tube 24 of testing cassete 10.Via predetermined profile (for example, ramp, arc and similar profile) corrugated tube 24 is applied to Pneumatic pressure and/or vacuum, this provides very in check method for the fluid flow profile in sample process part 12, with the fluid shear stress that may cause sample activation in limiting channel 22, and can avoid in addition the formation of bubble.The pneumatic input that inputs to testing cassete 10 and corrugated tube 24 via the flow limitation portion of testing cassete outside operates by the pulse-length modulation (PWM) of the solenoid valve due to control corrugated tube 24 pulsation causing and filters out.
Reagent restructuring and with mixing of sample 100 can be by by reagent or plurality of reagents is positioned at the diverse location in testing cassete 10 and make sample portion 100 be exposed to reagent realizes.Reagent can be positioned in fact any other position in testing cassete 10: well shape portion, passage, channel, chamber, corrugated tube and sample maintaining part, in these positions, reagent will contact with sample portion 100.Reagent can also be placed in sample contained structure 30.For example, heparinase can be placed in staging area 20 or other sample storage regions of testing cassete 10 in.Then sample portion 100 can be inhaled into staging area 20 and can keep contacting of enough time with heparinase, to dry heparinase is recombinated, and in and sample 100 in liquaemin.After this, sample 100 is drawn into corrugated tube and flows through reagent well shape portion, i.e. passage 22 ", herein, treated sample 100 will contact with other reagent.Drop reagent (spot reagent) almost can be applied on testing cassete Anywhere, and additionally, reagent can Covering samples contained structure 30.Therefore, it should be understood that according to the testing cassete 10 of different embodiments of the present utility model and can there is the almost a large amount of different reagent of a large amount of diverse locations that are positioned at testing cassete of any array configuration.
Name is called the U.S. Patent No. of " Method and Apparatus for Monitoring Anti-Platelet Agents(is for the method and apparatus of monitoring anti-platelet medicine) ": 6,613,573, name is called the U.S. Patent No. of " Method and Apparatus for Hemostasis and Blood Management(is for stopping blooding and the method and apparatus of blood administration) ": 6,787,363, name be called " Method and Apparatus for Diagnosing Hemostasis(for stop blooding diagnosis method and apparatus) " U.S. Patent No.: 6,797,519, name is called the U.S. Patent No. of " Method and Apparatus for Monitoring Hemostasis in Connection with Artificial Surfaces Devices(is for the method and apparatus in conjunction with manually showing device monitoring hemostasis) ": 6,890,299, name is called the U.S. Patent No. of " Protocol for Monitoring Platelet Inhibition(is used for monitoring the inhibiting scheme of blood platelet) ": 7,179,652, name is called the U.S. Patent No. of " Protocol for Risk Stratification of Ischemic Events and Optimized Individualized Treatment(ischemic event risk stratification and optimized individual therapeutic scheme) ": 7,524,670, name is called the U.S. Patent No. of " Protocol and Apparatus for Determining Heparin-induced Thrombocytopenia(is for determining scheme and the equipment of heparin-induced thrombopenia) ": 7,811,792, name is called the U.S. Patent No. of " risk stratification and the optimized individual therapeutic scheme of Protocol for Risk Stratification of Ischemic Events and Optimized Individualized Treatment(ischemic event) ": 7,939,329, name is called the U.S. Patent No. of " scheme that Protocol for Monitoring Direct Thrombin Inhibition(monitors direct fibrin ferment) ": 8, 008, 086 and name be called the U.S. Patent No. of " risk stratification and the optimized individual therapeutic scheme of Protocol for Risk Stratification of Ischemic Events and Optimized Individualized Treatment(ischemic event) ": 8, 076, 144, the disclosure of these patents is clearly incorporated to herein by reference at this, they have instructed multiple possible reagent and corresponding detection and scheme.Reagent can be as described in these patents, or can use other reagent, and/or testing cassete is configured to carry out other schemes.
Sample holding structure 14 is communicated with second channel 22, and comprises the contained structure 30 that keeps or hold sample portion 100 for the test process in sample portion 100.For example, sample holding structure 14 can comprise ring-type, cylindricality, cup-shaped or similar contained structure 30, and it provides the sample surface that can freely be encouraged and obtain resonance or approach the vibration of resonance, and can observe by sensed device.A contained structure 30 comprises and holds wall, and two surfaces that this holds wall and reserve sample cause resonance or approach the vibration of resonance for being energized.This sample can be directed to contained structure 14 via extending through the side ports of holding wall.Above-cited U.S. Patent No. 8,236,568,7,879,615 and 7,261,861 has been described several extra possible sample contained structures 30, and all these is the applicable structure using in the embodiment of testing cassete 10 being considered.
The testing cassete 10 that is filled with sample 100 can use at the equipment 102 for measuring hemostasis.In Fig. 2, schematically show, the parts of equipment 102 are: driver, Vib. or similar stimulus generator 104; Inductor/detecting device 106, processor 108, user interface 110 and communication link exchange device 112.Suitable charger (not shown) is provided.Driver 104 can be coil, piezo-electric device, motor, acoustic actuator or any suitable device, so that via the direct stimulation to maintenance equipment 14 or indirectly cause that via the excitation to testing cassete 10 or its part or both combinations sample keeps the resonance excitation of the sample 100 in equipment 14.Inductor 106 can be optical/laser device.User interface 110 can be hard button, touch screen or any suitable interface, makes user can testing scheme be selected and be started, and watches or affect record or the transmission of result.Be operably connected these functional parts and for the connection undertaken by communication link exchange device 112 facilitates, communication link exchange device 112 can be the wireless or wired socket in accordance with any suitable scheme of processor 108.For example, communication link exchange device 112 can be for being passed to result data in teleprocessing device, to analyze and diagnose, and for reception result analysis, thereby show with the form of data and figure via user interface 110.
Testing cassete 10 is placed in testing apparatus 102.Blood sample 100, such as fresh whole blood, blood constituent etc., is introduced in the reservoir 18 in testing cassete 10 via port 20.Equipment 102 is configured to apply selectively pneumatic singal, vacuumize or activate the valve in testing cassete 10 such as the select location place on the surface 32 of testing cassete 10, with the testing scheme be scheduled to by with the mixing and be passed to subsequently sample holding structure 14 and nurse one's health sample portion 100 of reagent.
Testing cassete 10 can be by stacking cut layer or cross cutting to form, to create functional part: valve 26, corrugated tube 24, passage 22 and fluid retaining zone/reservoir 18 layer by layer.This testing cassete can also by after a while stacked, connect or the injection mo(u)lding layer or the hot pressing lamina that fit together assemble.Independent layer can form in many ways, the structure order that when enters box depending on them.
The material of every layer is selected from suitable material.For cut and cross cutting laminate, structural sheet can be suitable plastics, such as polyethylene terephthalate (PET), Biaially oriented polypropylene (BOPP), cyclic olefin polymer (COP) or cyclic olefine copolymer (COC).Laminating adhesive can provide separately or provide with structural sheet.The layer of flexible membrane, such as being used to form valve, corrugated tube etc., can be polyurethane, silicones, polypropylene (PP) or tygon (PE).Conventional switch technology can be used to prepare these layers in the time that they comprise more than a kind of material.
According to the layout of testing cassete, can select to reduce to hydrophobic film material and size the cost of the material that each box uses, and in the testing cassete 10 that allows more easily film to be placed on automatically.Pore size and material thickness can be for controlling velocity of blood flow and entering in box and enter the amount in corrugated tube.The passage that passes to film can be little volume, to reduce sample or reagent loss.In this application, these are achieved, thereby have reduced blood sample loss and prevented reagent concentration error.Other passages can be larger volumes, to facilitate for sample is for example passed to sample holding structure 14 in box.
In one embodiment, it is 0.017 square millimeter or larger that the via dimensions that is communicated to sample holding structure 14 can be made as cross-sectional area, to in the case of not to the hematoblastic obvious shearing activation in sample or due to the shearing with respect to reagent with expose caused unexpected activation, promote processed sample flow to sample holding structure.Can use 0.20 square millimeter or larger suitable dimension, for example, be 0.30 square millimeter.
Fig. 3 shows with figure can be for test sample, such as the testing cassete 200 for the hemostasis sample of whole blood or blood constituent sample is tested.Testing cassete 200 has and the similar feature of testing cassete 10, but has been to provide the possibility of multiple tests of simultaneously carrying out.That is to say, the each passage on testing cassete can comprise different reagent, and therefore forms different tests or can be configured to the test that provides unnecessary.Combined test can component analysis.Testing cassete 200 is configured to carry out nearly 4 tests simultaneously, but in use, can carry out the combination in any of 1 to 4 test.Testing cassete 200 also illustrates that testing cassete can be made with in fact any amount of test, wherein Fig. 1 and Fig. 3 explanation can be made the testing cassete of the testing cassete of at least single test and the testing cassete of 4 tests, 2 or 3 tests, and can make the testing cassete having more than 4 tests.A path of testing cassete or multiple path can be a test department or multiple test department, for testing the specific features of hemostasis, this specific features can be in the analysis of the relevant feature of this hemostasis, such as biologically active pdgf, ischemic risk indicator or as set forth in aforesaid U.S. Patent.Testing cassete 200 can be configured to provide multiple tests or can be manufactured for the same test to multiple different samples is provided or both combinations.
As shown in Figure 3, testing cassete 200 is formed with 4 test department A, B, C and D.Each test department on testing cassete 200 comprises sample process part 212, sample retaining part 214 and outstandingly meets portion, for example beam 216, and this beam is structurally, be connected to processing section 212 by sample retaining part 214 on mechanics.The parts of corresponding test department are indicated by alphabetic flag A, B, C or D individually.Allow sample retaining part 214 as the spring carried mass with respect to sample process part 212 with the multiple beams 216 shown in cantilevered construction, and allow sample retaining part 214 to vibrate in response to imposing on the stimulation of holding structure 214 and/or testing cassete 200.Also can use and can mechanically connect and allow simultaneously sample retaining part to carry out other structures that relative dynamic moves, such as spring, Multi-link suspension, one or more semi-rigid member etc. with respect to sample process part.It should be understood that the less displacement that needs sample, that is, and vibration.In some embodiments, may directly connect sample process part 212 and sample holding structure 214, even make their members that forms as one.
Sample process part 212 can comprise that, by the common port of inlet chamber or manifold feeding or independent port 218, liquid sample 100 can be introduced into by this port the test department of sample process part 212.Port 218 can be self-packing, once sample is introduced in testing cassete 200, not from testing cassete outflow, leakage, seepage etc.Port 218 is communicated with corresponding preliminary reservoir or the sample retaining zone 220 that receives sample.Sample process part 212 also comprises: passage, channel, path and similar structures 222; Corrugated tube or pump 224 and valve 226, for sample 100 or one partial response are controlled through the movement of sample process part 212 in the actuating of corrugated tube 224, to prepare the sample 100 for testing.Impose on corrugated tube 224 external pneumatic pressure and selected valve 226 is operated, this makes sample portion 100 be siphoned away and pass through and enter first passage 222 ' and corrugated tube 224 from reservoir 220.First passage 222 ' can comprise the test agent that is liquid, gel, cryodesiccated, dry form, when sample is inhaled into and during by passage 222 ', test agent is mixed with sample.As described herein, reagent can be positioned at other positions of testing cassete 200.The circulation of corrugated tube 224 can be as mentioned above by the pulse-length modulation of pressure and vacuum signal is realized, and the circulation of corrugated tube allows by repeatedly sample 100 being passed to first passage 222 ' and making it pass first passage 222 ', sample and reagent to be mixed.Control to valve 226 and the actuating of corrugated tube 224 is allowed condition sampling section 100 by second channel 22 " be passed to sample holding structure 214 and sample contained structure 230.In testing cassete, be provided with suitable refuse chamber, to guarantee holding of sample.
The testing cassete 200 that is filled with sample 100 is prepared subsequently, and to prepare being used for being introduced into testing apparatus to carry out test, testing cassete is constructed and reports accordingly result for this reason.
Fig. 4 and Fig. 5 have described sample holding structure 300, and this sample holding structure can be used as any one that corresponding sample holding structure 30 or 230 is used in testing cassete 10 or 200.Sample holding structure 300 has the annular solid 302 that comprises first end 304 and the second end 306.First end 304 has end face 308, is formed with the projection 310 around whole side face in end face 308.Liquid sample, such as whole blood or blood constituent, for example, is introduced into sample holding structure 300 by the side ports not being illustrated, and is driven to enter annular solid 302 by corrugated tube 224 towards controlled compression or the activation of first end 304.Annular solid 302 is filled and overflows to guarantee that all inside surfaces are moistening by sample, and subsequently the sample volume in annular solid to reduce to form convex surface 312(shown in broken lines), this convex surface extends from first end 302.Observed in the sample in annular solid 302 is placed into as the resonance oscillations of the results of stimulation of testing cassete 10/200 time is this convex surface 312.The diameter of projection 310 and other physical dimensions of testing cassete also contribute to foundation to be placed in the consistent volume of the sample of resonance oscillations with the control that convection cell is processed structure, therefore do not need complicated calibration process.
Although can observe whole convex surface 312, a part of only observing free face may just be enough to produce useful result.For example, can observe the core of convex surface 312.
Fig. 6 shows sample holding structure 400, and this sample holding structure can be used as any one that corresponding sample holding structure 30 or 230 is used in testing cassete 10 or 200.Sample holding structure 400 has the annular solid 402 that comprises first end 404 and the second end 406.First end 404 has the end face 408 being formed as around the marginal texture 410 of whole side face.It is plane that marginal texture 410 can be essentially, and that is to say, all points around marginal texture 410 are located substantially in same plane.Liquid sample, such as whole blood or blood constituent, in side ports, 412 places are introduced into, and are driven to enter annular solid 402 by corrugated tube 224 towards controlled compression or the activation of first end 404.Annular solid 402 is filled and overflows to guarantee that all inside surfaces are moistening by sample, and subsequently the sample volume in annular solid to reduce to form convex surface 412(shown in broken lines), this convex surface extends from first end 402.Observed in the time that the sample in annular solid 402 is placed in the resonance oscillations as the results of stimulation of testing cassete 10/200 is this convex surface 312.
Although it is cylindrical that structure 300 and 400 is depicted as, sample holding structure is not limited to its shape.Sample holding structure only need have wall construction (for example the wall portion 314 of corresponding construction 300 and 400 or wall portion 414), to hold sample, can observe the synchronous vibration of sample with permission but reserve at least two free face to sample.For example, sample holding structure can be oval, prismatic, conical or in fact any suitable structure and geometric configuration, and allowing stimulates to resonate to sample, and sample responses is observed in the motion stimulating.
Fig. 7 shows and the similar testing cassete 500 of testing cassete 10, and wherein testing cassete 500 is configured to single test, although it can be configured to multiple tests, such as the situation of testing cassete 200.Test sample box 500 comprises the sample retaining part 514 in sample process part 512, box body 516.
Sample process part 512 comprises port 518, and the liquid sample of all samples as described previously 100 can be introduced in sample process part 512 by this port.Port 518 can be self sealss (as barrier film or other automatic sealing mechanisms), once sample is introduced in testing cassete 500, from testing cassete flow, leakage, seepage etc.Port 518 is communicated with the preliminary reservoir 520 that receives sample.Sample process part 512 also comprises: path, channel, refuse chamber, passage and similar structures 522; Corrugated tube or pump 524 and valve 526, for sample 100 or one partial response are controlled through the movement of sample process part 512 in the actuating of corrugated tube 524, to prepare the sample 100 for testing.
Aerodynamic force can be the vacuum of applied pressure, extraction or the two combination, and be vacuum in a preferred embodiment, this aerodynamic force can directly be used on sample 100, is handled to move in testing cassete 500 and to the various parts of testing cassete 500.In the embodiment illustrating, the vacuum that is applied to central port 519 places is loaded in staging area 520 testing cassete 100, and further sample 100 is aspirated in corrugated tube 524.Sample 100 is pumped down to drain port 528, thereby allows only by the physical dimension of box, sample fluid volume carefully to be controlled.Identical with testing cassete 10 or 200, without the monitoring load time or without the volume of sample 100 being carried out to sensing initiatively, thereby simplify structure and the operation of testing cassete 500.Same, prepare sample in mode as above, and be communicated with sample holding structure 514.
For the sample 100 in exciting test box 500, excitation stimulates can be applied to whole testing cassete 500.Arrow " A ", " B " or " C " indicate the excitation of single or multiple testing cassetes, and rotation excitation or its combination of therefore sample excitation, testing cassete.The excitation of testing cassete 500 causes the corresponding excitation of sample 100 to resonate, thereby observes to derive hemostasis feature.
Although described in this article according to some apparatus and method of instruction structure of the present utility model, covering scope of the present utility model is not limited therewith.Conventionally, equipment and method are provided for to obtain from liquid blood and start to continuous, the accurate result first that is transitioned into gel state below.The resonant frequency of the increase to sample is provided by the direct measurement providing the resilient property of material and corresponding haemostatic properties.
The utility model is contained all embodiment that fall into the literal instruction above or in the scope under doctrine of equivalents of claims of the present utility model.

Claims (22)

1. for a testing cassete for test sample, it is characterized in that, this testing cassete comprises:
Sample is prepared part, and this sample is prepared part and comprised fluid handling structure;
Test sample part, this test sample part comprises sample holding structure, described test sample part is prepared part via fluid passage and described sample and is connected, and described fluid passage provides the fluid between described fluid handling structure and described sample holding structure to be communicated with;
Described sample holding structure supports treats tested sample, make described sample to be energized to occur synchronous vibration in response to being applied to the excitation of described testing cassete, and described sample holding structure allow the described synchronous vibration of described sample to observe.
2. testing cassete according to claim 1, is characterized in that, described sample holding structure is attached to described sample and prepares part, makes described sample retaining part can be independent of described sample and prepares part and be separately energized.
3. testing cassete according to claim 2, is characterized in that, described sample holding structure is attached to described sample via the outstanding portion of connecing and prepares part.
4. testing cassete according to claim 1, is characterized in that, described testing cassete comprises the assembly of each parts.
5. testing cassete according to claim 4, is characterized in that, described testing cassete comprises laminar structure.
6. testing cassete according to claim 1, is characterized in that, described fluid handling structure and described sample holding structure comprise the structure of one.
7. testing cassete according to claim 1, is characterized in that, described fluid handling structure comprises corrugated tube, reservoir, multiple fluid passage and at least one valve operationally arranged.
8. testing cassete according to claim 1, is characterized in that, described fluid handling structure comprises reagent.
9. testing cassete according to claim 1, is characterized in that, described fluid handling structure comprises one or more reagent.
10. testing cassete according to claim 1, is characterized in that, described fluid handling structure comprises fluid passage and is arranged in the reagent in described fluid passage.
11. testing cassetes according to claim 1, is characterized in that, described fluid handling structure comprises fluid passage and valve, and described valve comprises the hydrophobic surface in described fluid passage.
12. testing cassetes according to claim 1, is characterized in that, described fluid handling structure comprises fluid passage and valve, and described valve comprises the flexible membrane in described fluid passage.
13. testing cassetes according to claim 1, is characterized in that, described sample holding structure comprises ring part.
14. testing cassetes according to claim 1, is characterized in that, the cross-sectional area that connects the described fluid passage of described sample preparation part and described sample holding structure is greater than 0.01 square millimeter.
15. testing cassetes according to claim 1, is characterized in that, the cross-sectional area that connects the described fluid passage of described sample preparation part and described sample holding structure is greater than 0.2 square millimeter.
16. testing cassetes according to claim 1, is characterized in that, the size for the treatment of the volume of tested described sample is that the volume based on described sample holding structure is determined.
17. testing cassetes according to claim 1, is characterized in that, the size for the treatment of the volume of tested described sample is that the volume based on described fluid handling structure is determined.
18. testing cassetes according to claim 1, is characterized in that, the physical dimension of described fluid handling structure determines the size of the volume of described sample.
19. testing cassetes according to claim 1, is characterized in that, described sample holding structure comprises the port in the sidewall sections that is formed on described sample holding structure, and described port is communicated with the sample support section of described sample holding structure.
20. testing cassetes according to claim 1, is characterized in that, described sample holding structure comprises projection, and the volume of blood sample is at least determined by the diameter of described projection.
21. testing cassetes according to claim 1, is characterized in that, described sample holding structure comprises the marginate end face of tool, and the volume of blood sample is at least determined by the diameter at described edge.
22. testing cassetes according to claim 1, is characterized in that, described sample holding structure comprises the cylinder of circle, ellipse, prismatic or taper.
CN201420171272.3U 2014-04-10 2014-04-10 Test box for sample testing Expired - Lifetime CN203825014U (en)

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Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN106248919A (en) * 2016-07-15 2016-12-21 重庆鼎润医疗器械有限责任公司 Method based on blood sample vibration detection coagulation
CN111366714A (en) * 2020-04-24 2020-07-03 北京森美希克玛生物科技有限公司 Thrombus elasticity measuring device and thrombus elasticity map obtaining method

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN106248919A (en) * 2016-07-15 2016-12-21 重庆鼎润医疗器械有限责任公司 Method based on blood sample vibration detection coagulation
CN106248919B (en) * 2016-07-15 2018-11-06 重庆鼎润医疗器械有限责任公司 Method based on blood sample vibration detection coagulation
CN111366714A (en) * 2020-04-24 2020-07-03 北京森美希克玛生物科技有限公司 Thrombus elasticity measuring device and thrombus elasticity map obtaining method

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