CN101657150A - Sensor for an analysis system - Google Patents

Abstract

An analysing unit for a system for analysing a fluid, the analysing unit comprising a first fluid communication link for communicating fluid with a base station, a second fluid communication link forcommunicating fluid with a substance collecting device, and sensing means adapted to provide data representing a content of a substance in the fluid.

Description

The pick off that is used for analytical system

Technical field

The present invention relates to a kind of system that is used for analysing fluid, particularly, measure the content of material in the fluid.This system comprises analytic unit and material gathering-device.

Background technology

The system of the above-mentioned type can be used for the concentration of measurement of species at fluid, for example measures the material in the body fluid, for example measures glucose.

In medical skill or scientific domain, such as the supervision of chemical process, can be accurately and measure continuously in such as the material of tissue or in such as some fluids of body fluid the importance of concentration of material well-known.It is the concentration of chemical substance in the monitoring bio environment that a kind of important medical is used, as the glucose level in the monitoring of blood.

For diabetics, monitoring glucose level is vital, because the raising of glucose level is represented such as produce or utilize the not enough hyperglycemia that causes or the situation of glycosuria owing to insulin in the blood.Perhaps, abnormal low glucose concentrations can be the signal of insulin surplus.Therefore, the measurement of blood sugar concentration is diagnosis, treats or control the important tool of various imbalances that wherein in described imbalance, known glucose concentrations is the indication of the situation existence or the order of severity.Thereby having following emergency, promptly existing amount of insulin is to surpass or be less than to handle the needed amount of particular glucose level at any time.When diabetic individual this stress situation under, such as operation or farrowing interval, this situation is especially serious.

Be not only diabetics, also can need to monitor their blood sugar level, such as acute patient with the corticosteroid treatment of pharmacology dosage for the ND.

In biotechnology, other interested application be keep and control nutrient in the cell culture reactor, such as the specific concentration level of glucose, wherein need long-term stability to supply the required feedback information of medicine system, thereby specific chemical drugs can be maintained in the pre-set limit so that Control Computerization to be provided.

Measure particular chemicals in the solution, illustrate in many files such as the example of the concentration of glucose, such as WO9939629A1 and US4452887.The latter has described a kind of assay method, wherein uses oxydasis test material or its product, and determines by the whole bag of tricks with the hydrogen peroxide that oxidation forms simultaneously.This becomes very important recently.Reason is that determination of peroxide can accurately be measured by colorimetry afterwards at the color producing reaction (dye-forming reaction) that uses peroxidase, perhaps passes through electrode reaction.According to US4452887, the known colorimetry of using Trinder reagent based on aforementioned principles.Adopt the method, hydrogen peroxide and peroxidase reaction that the oxide enzyme reaction forms, with the oxidation coupled reaction of catalytic amino peace body than woods and phenol, colorimetric method for determining is passed through in the dyeing of Xing Chenging thus.The value of response system is that the same detection system can be used for oxidase not of the same race, and system to the application of various analyses just under study for action.In these oxidase, especially the important enzyme in the clinical chemistry has glucose oxidase, cholesterol oxidase, uricase, glycerol oxidase, phosphoglucose oxidase etc.

For the improvement system, can introduce enhancer, such as what in WO9105872A1, describe, it has described a kind of enhanced chemiluminescence assay method, wherein such as the DPD (dihydrophthalazinedione) of luminol (luminol) reagent, such as the peroxidase of HRP with such as oxidant reaction jointly under existing of H2O2 such as the situation of (p)-iodophenol.Enhancer produces by the enzymic catalytic reaction of positive enhancer (pro-enhancer), and for example (p)-iodophenol is decomposed by alkali phosphatase (alkalinephosphatase), and this endonuclease capable is chemically examined but not peroxidase.Selectively, add enhancer, such as the anti-enhancer (anti-enhancer) of (p)-nitrophenols by such as pNPP (p-NitrophenolPhosphate) just-enzymatic reaction of anti--enhancer produces, and the minimizing of luminescence emissions is measured.

This chemiluminescence chemical examination is described to " enhancing " in the sense: the total light yield of reaction and/or signal/background ratio is greater than the total light yield of carrying out under no reinforcing agent situation that same reaction obtained and signal/background ratio.

Known general patient monitoring system, a kind of surveillance as having described among the US3972320, when situation about monitoring when monitoring station surpassed predetermined threshold, it produced alarm at central station.This surveillance is particularly suited for monitoring the important function of a plurality of patients in the hospital, and therefore whether a person on duty can be warned and have any patient to need emergent management.Monitor unit can be carried by patient, and with the form of wrist accessory, the communication line of suitable wireless radio transmission is provided for the one-way transmission from the monitoring station to the central station suitably.Each monitoring station development and deal with data are to determine whether situation about monitoring has value to surpass and limit boundary; If have, confirmation signal is transferred to central station, to send the signal that there is emergency in monitoring station.Each monitoring station all comprises the data processor that is composed of program, thereby does not need variable data is transferred to central station.In order to confirm the purpose of monitoring station, data only fixing or storage are transmitted.The processor electronic component is properly mounted in the large-scale integrated circuit.

Multiple systems has been developed and has been used for this successive material measurement, has described a kind of implantable sensing arrangement with long-time stability such as WO99/39629.This sensing arrangement utilizes the microdialysis Sampling techniques, and comprises the miniflow reservoir, the pick off that it makes reagent and target chemical qualitative response and is connected to the miniflow reservoir, and it is used to survey the reaction of reagent and target chemical matter.Pick off can comprise thermopile or optics battery (optical cell).

In a sensor construction, invention comprises: (i) optics battery and (ii) microdialysis tube for transfusion.This sensing arrangement combines the microdialysis Sampling techniques with the micro-fluidic system that utilizes the optics battery, to produce the system that can accurately measure with the concentration of glucose in the proteinic complex solution and other chemical substance.In the described embodiment of this document, the biochemical sensitive system comprises having the pressurizing vessel that is used to keep reagent, calibration solution and scans the contraction bag of solution (sweep solution).Flowing of they regulated by resistance tube, and as previously mentioned, the diameter of this resistance tube and length can be selected, to realize the typically flow rate of per minute time microlitre mode.

Scanning solution is by connection tube, typically microporous pipe is directed to the microdialysis fiber, and this microdialysis fiber spreads and contacts (diffusive contact) with experimental enviroment, biological example reactor perfusion loop.With the speed of 300nl/min roughly and about 2 minutes dead time by about 10 to 2000mm microdialysis fiber, the target chemical matter concentration in the scanned fluid can reach and the experimental enviroment diffusive equilibrium.The dialysis solution that returns (that is the scanned fluid that, comprises target chemical matter) mixes with particular agent then.Mixed solution moves along single tube or capillary tube, and wherein the chemical reaction of reagent and glucose carries out, and optical change generation, i.e. reagent-dialysis solution mixing volume.The stream that flows is measured by the optics battery with light emitting diode and microdiode photodetector (optical cell) the absorption of the chemical-sensitive dyestuff of stable color.The photo detector signal that produces is calibrated about concentration of glucose by microcontroller.

The microdialysis that contacts with testing liquid, be also referred to as the film doughnut and make, but do not comprise the macromolecule material by the material of permeable glucose.Typically, the microdialysis tube for transfusion is made by following material, and such as cellulose acetate, polysulfones and polyacrylonitrile, form is diameter 200 micron-sized hollow pipes usually.Select and the mutually blended reagent of scanned fluid, thereby their color or fluorescence have the special response for the biochemical substances that requires, as known in the art.

Optics battery measurement color or change in fluorescence at the receiving terminal place of mix reagent stream, and be associated with chemical substance concentration by microcontroller from the signal of its acquisition.

Miniflow reagent reservoir can be connected to pick off away from pick off and by the conduit that comprises microporous pipe (microbore tubing).Typical embodiment is, the reservoir that contains enzyme or chemical system is away from pick off, and the conduit of the appropriate length by having microporous pipe and electric lead is connected to pick off.The form of this system also can be the reservoir of little storage, may be the size and the shape of pacemaker, and it comprises the device that the syringe needle that is used to pass the container septation recharges.This system can be by recharging with the similar mode of implantable drug-supplying system, and barrier film is pierced through by percutaneous syringe needle thus.

Yet be mixed into scanned fluid when a plurality of reagent fluids, perhaps during sample fluid, this system is not very suitable.If before adding second reaction liquid, first fluid needs fully mix especially this situation with scanned fluid.Reason is, all needs connection tube for the different reagent fluids with each of scanned fluid, and needs other pipe after each mixes, to make the response time complete before adding the novel agent fluid.This will need the connection of a plurality of different pipes, increase a plurality of manufacturing steps thus, and damage one probability in the little and frangible relatively pipe.Further, consider the microsize of pipe, may be difficult to that fluid therefore to be mixed also mixes with predetermined layer and design layering with they correct also alignment evenly.

Other method that stream is communicated with per minute microliter amount level comprises the microchannel that forms with silicon or glass, is used for chemical analysis.An example is to be used for US5,644, the system of the injection flow analysis described in 395, wherein a small amount of chemical reagent and sample mix to be incorporated in this running system mutually and react, and wherein size is guaranteed Capillary Flow, and product by optically, electrically or alternate manner detect.Mobile for regulating, little valve is mounted from the teeth outwards.Capillary channel comprises and is used to make the blended part of fluid, is used to take place the part of needs reaction, and probe portion.

The technology of utilizing chemical reaction to analyze in the also known use microdialysis field is monitored material, constantly such as the concentration of glucose in tissue.At US5,640,954, in the microdialysis probe implanting tissue, and to give by perfusion of fluid and to be sent, this perfusion of fluid is removed as sample after being rich in the material of self-organizing.Fluid guiding is by guard system, and wherein enzyme is added and electrochemical sensor writes down measurable chemical reaction.Flow rate in the system is quite little, and its scope is that 0.1 microlitre per minute is to 15 microlitre per minutes.Mobile for producing, introduce first and second transmitting devices, preferably with rotation or piston pump, wherein compactness is provided with and will uses single pump (single pump) also by using the management and control system flow rate of different-diameter.

At another US6, in 572,566 the patent, the idea that is flowing in the groove is combined with the direct analysis of body fluid.System comprises the integrated reservoir that is connected to groove, and exchange area, from entering groove around the material of body fluid by exchange area, for example passes through dialyzer.In order to transmit fluid, pumping system is recommended based on pressure vessel, is filled with the pressure vessel of gas-pressurized and contacts with second container that is divided into two parts by compliant member.First comprises liquid, and second portion holds gas-pressurized, makes the compliant member displacement, and liquid is clamp-oned tank systems.Current limiter with the amount of liquid of restriction from the reservoir appearance, and makes constant flow in the pumping system downstream.

File WO2005111629 has described a kind of micro-analysis system that is used to utilize fluid media (medium) analysis species, described system comprises the sensing device that is used for from the medium collection species, described sensing device has entrance and exit, the analytical equipment that comprises groove, described groove is defined for blended at least a portion, the at least a portion that is used to react, measure detecting structure to be determined at least a portion of described measurement section office species concentration with being used to, the first fluid reservoir that keeps carrier fluid, with at least one the second fluid storage portion that keeps reagent fluid, connecting device, it comprises first connecting device of the fluid connection that is used between first fluid reservoir and the analytical equipment, and be used for second connecting device that the fluid between the inlet of second fluid storage section and sensing device connects, and be used for the 3rd connecting device that the outlet of sensing device and the fluid between the analytical equipment connect, described first connecting device comprises that at least one first current-limiting apparatus and described second connecting device comprise at least one second current-limiting apparatus, it is characterized in that described micro-analysis system further comprises the storage device with described first fluid reservoir and described second fluid storage section, described storage device is connected with the device fluid that is used for the pressurization of described fluid storage portion in the downstream, and described storage device separates with described analytical equipment with described pressue device.

Yet in this document, analytical equipment (50) is the integration section of analytical system (200), also comprises reservoir (12-15) and pressue device (1).Therefore, consider: for example system's operation is with monitoring patient's physiological conditions, this system can not be in conjunction with following: patient needn't put on whole analytical system (200) convenience, sample device (60) is connected to the mobility of the reduction that the short response time of analytical system (200) and this short tube will bring to patient by adopting short tube.

Summary of the invention

The objective of the invention is to improve said system, and realize such system, wherein the material in the fluid is measured continuously, and this system has the cheap and independent use part that exchange easily that is easy to make.

Therefore the present invention relates to a kind of system that is used for analysing fluid, this system comprises preferred reusable base station, preferably away from the analytic unit of the disposable use (single-use) of the cheapness of base station, and away from the base station and away from the disposable use material gathering-device of the preferred cheapness of analytic unit, the first fluid communication line that is used for communication of fluid between base station and analytic unit, and be used for the second fluid communication line road of communication of fluid between analytic unit and material gathering-device, wherein analytic unit comprises sensing device, described sensing device is suitable for providing the data of content of material in the expression fluid, and wherein the base station comprises data processing equipment, and this data processing equipment is suitable for handling the data that provide about the information of content of material in the fluid.

The first fluid communication line has the flow resistance than the second fluid communication line Lu Gengxiao, and in order to ensure the response time that shortens material gathering-device collection of material sample, the second fluid communication line road is shorter than first fluid communication line, and this also is a reason of introducing remote analysis unit.

The base station comprises accountant and cheap disposable stocking system, and this stocking system is connected to analytic unit by the first fluid communication line, and wherein stocking system can be dismantled from accountant.The base station further comprises pumping installations, and this pumping installations can and be dismantled from analytic unit thus from the stocking system dismounting.This reusable base station made from separating of disposable stocking system, analytic unit and material gathering-device (being referred to as wet end) replaces exhausted wet end with the new wet end the sterilization wrap easily.

In order to transmit data and/or energy, analytic unit and accountant electrical communication.

In order to ensure the fluid that does not have in the exterior materials pollution stocking system, stocking system comprises the flexible reservoir of at least one and pressure chamber pressure communication, this pumping installations is extruded stocking system with fluid thus with air or fluid filled pressure chamber, and does not directly contact with fluid all the time.

This measurement is based on adding fluid to sample fluid, and with the optical change of generation expression investigation material concentration, so analytic unit comprises the optical pickocff that is arranged to the micro-fluid chip optical communication.

Preferably, analytic unit and material gathering-device are made by the material monolithic that allows nuclear magnetic resonance scanning at least.

Analytic unit is used for the content of material of analysing fluid, and therefore comprises sensing device, and it is suitable for providing the data of content of material in the expression fluid, and wherein sensing device comprises:

-have an analysis micro-fluid chip of at least one analysis vat; With

-optical pickocff.

Obtain being reflected in the analysis micro-fluid chip of optical change and carry out, and in order to ensure fluidic abundant mixing, at least one analysis vat of analyzing micro-fluid chip comprises circuity part.

Can observe optical change in order to ensure optical pickocff, the covering by transparent top to small part of this at least one analysis vat.

In order to distribute a fluid to the analysis micro-fluid chip, it is communicated with at least one afflux chip concentrated flow body of afflux micro-fluid chip.

In order to ensure not having undesirable element or particulate matter to enter the analysis micro-fluid chip, filter is disposed in the afflux micro-fluid chip and analyzes micro-fluid chip then.

For regulated fluid flowing in system, at least one that analyze in micro-fluid chip and the afflux micro-fluid chip comprises at least one groove, and slot part of the flow resistance of the increase of providing is provided for it.

Preferably, the flow resistance of increase is provided by a capillary tube that is arranged in the groove.

Owing to measure based on optical detection, therefore importantly guarantee do not have external light source to enter analytic unit, therefore supporting construction is arranged in optical pickocff and analyzes between the micro-fluid chip, supporting construction comprises first window, and described first window is arranged to help optical pickocff and analyzes optical communication between the micro-fluid chip.

For guaranteeing stability, optical sensor arrangement is in depression, and this depression is arranged on first side of supporting construction, and optical pickocff is fixed in the shell that comprises second window, and this shell and pick off are positioned in the depression, thereby first window aligns with second window.

For guaranteeing to analyze the free optical communication between micro-fluid chip and the optical pickocff, and guarantee that the reaction that obtains the detectable effect of optics has the enough time, analyzing micro-fluid chip and comprise the transparent top that covers at least one circuity part, aligns with first window in the top.

For reservoir is constructed easily, it comprises:

-element on the pressure side, it has the inner surface that forms the opening that leads to first group of chamber;

-fluid side element, it has the inner surface that forms the opening that leads to second group of chamber; With

-flexibility or deformable film,

On the pressure side element becomes opposite inner surface on the opposition side of film with the fluid side arrangements of elements, the register in the chamber on the opening that therefore leads to the chamber on the side of film and the opposition side that leads to film, and film makes the chamber on film one side separate with chamber on the film opposition side, on the pressure side the inner surface of element comprises the first pattern recess, with film, chamber and the fluid between the outside that this first pattern recess forms first group of chamber are communicated with.

For guaranteeing fluidic fluid issuing in the reservoir, the inner surface of fluid side element comprises the second pattern recess, and this second pattern recess is communicated with chamber and the fluid between the outside that film forms second group of chamber.For guaranteeing that further film never blocks fluid issuing, at least one in the first and second pattern recesses extends in the chamber.

For forming groove from the first and second pattern recesses, at least one in the element is connected to film, preferably by welding, such as laser weld or ultrasonic bonding.

Barometric gradient in order to ensure the film both sides can be extruded reservoir with fluid, in first embodiment, film comprises flexible portion, its other parts than film have more elasticity, flexible portion is between the chamber of alignment, and wherein flexible portion is suitable for being badly deformed at least one shape in two chambeies on each side of flexible portion.

In a second embodiment, membrane portions is shaped as the interior shape that at least roughly cooperates at least one in the chambeies of two alignment.

Be the chamber of sealant flow side element, film also is connected to the fluid side element around the recess of the second pattern recess around the marginal portion in second group of chamber.

Equally, for the chamber of sealing load side element, film also is connected to element on the pressure side around the recess of the first pattern recess around the marginal portion in first group of chamber.

For preventing to use preceding fluidic flowing, the fluid side element comprises the valve through hole, wherein film centers on the valve through hole to being connected to the fluid side element, therefore at least one another valve through hole on the inner surface of each valve through hole and fluid side element is centered on by engaging zones, along described engaging zones, film is connected with the fluid side element.Then, removable valve portion be positioned to first end on the flexible membrane flexible membrane is pressed on the fluid side element, block any fluid intake that passes the valve through hole thus.

In order to realize that each is communicated with the fluid between two valve through holes of valve through hole, the fluid side element is connected to the afflux element with afflux recess, and this afflux recess forms the interior geometry in the afflux component inner surface.The afflux element is connected to the fluid side element, and wherein inner surface is towards the outer surface of fluid side element, and outer surface is opposite with the inner surface of fluid side element.

The second pattern recess is communicated with afflux recess fluid by storing through hole, and the fluid that the afflux recess produces between the second pattern recess and the valve through hole thus is communicated with.

In order to store the waste liquid that returns from analytic unit safely, in reservoir, introduce waste chamber, it is communicated with first's fluid of recess in being formed on the fluid side component inner surface, the first of recess is communicated with the first check-valves vented liquid, and the second portion of recess is communicated with the second check-valves vented liquid, wherein each in the check-valves through hole all with the internal fluid communication of the check-valves geometry of the afflux element that is furnished with check-valves, guarantee that the fluid via check-valves is communicated with between the first and second check-valves through holes.

Waste chamber is formed by the waste chamber in the inner surface that is arranged on the fluid side element at least in part.

If the afflux element is not a fluid-tight to the connection of fluid side element, for guaranteeing do not have fluidic mixing to occur in the afflux recess, drain tank is arranged between any two adjacent afflux recesses, and rhone is parallel to any two adjacent afflux recesses.

For guaranteeing simply also can connect and removably connect fast between pumping installations and the stocking system, be connected with positive connector, and seal member, the sealing parts are fixed in the groove of positive connector, negative connector forms the chamber that holds positive connector, and seal member is slightly larger than the chamber, so when positive connector is contained in the negative connector, the inwall of seal member engagement cavity.

Description of drawings

Fig. 1 has shown whole system;

Fig. 2 has shown whole microdialysis probe;

Fig. 3 A﹠amp; 3B has shown whole micro-fluid chip;

Fig. 4 A﹠amp; 4B has shown the pipe that is connected with passage fluid in the micro-fluid chip;

Fig. 5 has shown and has comprised fluidic stocking system;

Fig. 6 has shown the bottom and the afflux element of stocking system;

Fig. 7 has shown the rough schematic of fluid storage portion;

Fig. 8 A-8C has shown fluid storage portion, space, full and at system's run duration;

Fig. 9 A﹠amp; 9B has shown two kinds of forms of waste liquid chamber;

Figure 10 has shown the block diagram of base station;

Figure 11 has shown the feature of drainage channel;

Figure 12 has shown the pump connection;

Figure 13 has shown the analytic unit system;

Figure 14 has shown the analysis micro-fluid chip;

Figure 15 has shown the afflux micro-fluid chip;

Figure 16 has shown the filter that filters in the recess;

Figure 17 has shown the reducer set;

Figure 18 has shown the reducer that inserts in the passage;

Figure 19 A and 19B have shown another selection of the afflux element of stocking system; With

Figure 20 A and 20B have shown another selection of valve.

The specific embodiment

It below is the detailed description of the preferred embodiments of the present invention.

Fig. 1 has shown the system (1) that is used for measuring such as the concern material of gas or fluidic medium, and wherein in more specific examples, described medium is blood or bodily tissue.In a preferred embodiment of the invention, system (1) comprises base station (2), this base station (2) comprises and has fluidic interchangeable fluidic component and optionally have a pump installation, and electronic unit, this electronic unit comprises computer that is used to store also possible deal with data and the display that is used to show measured value.Be connected to civil power, perhaps optionally, portable computer especially comprises its oneself power supply, such as battery or fuel cell optimum system choosing.

Base station (2) is communicated with analytic unit (3) fluid by first fluid communication line (4), in this first fluid communication line (fluid communication link) (4) preferably medical injected system field the flexible pipe of buying of common type of service.Analytic unit (3) is preferably tied up arm or the wrist of the patient under monitoring, may pass through patch, and comprises the sensing device that is used to carry out the material concentration analysis.Be used for being communicated with analytic unit (3) fluid by the second fluid communication line road (7) from the material gathering-device (5) of tissue (6) collection of material.Electrical interconnection (8) is guaranteed one or more operations that analytic unit is connected with power supply, and the numeral that will measure or analog data are transferred to the base station and/or from the base station from analytic unit.In specific embodiments of the present invention, this can be substituted by radio communication.

Fluid communication line road (4) is included in the set of a plurality of single tubes (408) in the common coating, as illustrating after a while.

Material gathering-device (5) is the structure that can collect any kind of paying close attention to material from medium (6), but in a preferred embodiment of the invention, it is the microdialysis probe that to buy, or a kind of like this probe, wherein: infusion liquid is transferred to first side of semipermeable membrane and second side of this semipermeable membrane contacts with medium (6).When infusion liquid during along membrane flow, because they diffuse through film from medium (6), so it collects related substances, and this is rich in the fluidic infusion liquid of material, is called sample fluid now, takes out from film then to be used for further analysis.The exemplary embodiments of this probe has been described among the WO9413195A1.

Fig. 2 has shown the simple view of this probe (5), the wherein end (11) of tubulose semipermeable membrane (10) sealing, and near-end (12) is around connecting fluid in front conduit (13) and rear fluid conduit systems (14).Perfusion of fluid is supplied to film inside (15) by the fluid in front conduit, and flows out by the rear fluid conduit systems.(13) are sent to rear (14) fluid conduit systems from the place ahead owing to perfusion of fluid, and it collects the material that sees through the film diffusion from surrounding medium (6).Thereby, be rich in material perfusion of fluid, be called sample fluid, leave by rear fluid conduit systems (14).

Conduit (13,14) is the fluid migration pipe of buying of standard preferably, and its size is at micron order, as the coated glass pipe, inside diameter ranges at 5-50 μ m and the external diameter scope at 500-1000 μ m.Yet, also can use other material.Conduit (13,14) can be arranged to single pipe, perhaps comprises the single tube of two conduits (13,14) side by side, perhaps can be the concentric system of a conduit in another.

Replace tubular film (10), can adopt in a conduit (13,14) and window.

Fig. 3 A has shown whole micro-fluid chip (20), and wherein substrate (21) has groove on a surface, forms flow path (22).Though it is called as plate, can adopt to have the arbitrary shape that at least one is suitable for forming the surface of flow path.

Substrate (21) preferably wherein forms the substrate of flow path.It can be made by polymer material, includes but not limited to polystyrene (PS), polymethyl methacrylate (PMMA), polyethylene terephthalate (PETG), cyclic olefine copolymer (COC), and/or any appropriate polymer material.Optionally, substrate can be made by other suitable material of non-polymeric body.Can use any appropriate kind technology in substrate, to form flow path,, perhaps can use the injection molding technology to make substrate, in the case, in substrate, form flow path during the manufacture process such as etching or hot-forming.Optionally, can use in the prior art known any other appropriate technology itself to form first flow path.Flow path will normally be formed in the surface portion of substrate.

By utilizing top board (23) covered substrate (21), make flow path (22) fluid-tight, wherein first top board can be a size and the similar plate of size of substrate (21), perhaps thin foil, and align with substrate (21), make flow path (22) form passage (26) thus.Top board can be and the first substrate identical materials, or other suitable material, as above-mentioned, and in a preferred embodiment, it has general plane and slick surface, may have the through hole (25) that aligns with flow path (22), realizes that passage (26) is to extraneous path.

Preferably, top board by laser weld, ultrasonic bonding, thermal weld or arbitrarily other welding method be connected to substrate, but can use other method arbitrarily, as glueing joint by any known means or bonding.It can be connected to the whole surf zone that substrate does not have flow path, perhaps only centers on the edge of flow path.

Fig. 3 B has shown the specific embodiments of similar whole micro-fluid chip (20), wherein top board (23) is the mirror image of substrate (21), also comprise flow path (22b), therefore when two plates (21,23) connect, flow path in the top board aligns with the flow path (22a) of substrate (21), the passage (26) that forms is partly in substrate (21), partly in top board (23).

Fig. 4 A illustrates the side view of whole chip (20), and its mesopore (30) penetrates the side of substrate (21), and hole (31) penetrate the bottom of substrate (21), and the hole (25) on hole (32) and Fig. 3 A penetrates top board (23).Below, any this type of produce path from passage (26) to the external world, penetrate substrate (21) or top board (23) or both holes (30,31,32) and be referred to as opening.

The pipe that picture forms first fluid communication line (4) is connected to opening in the following manner: they are pushed towards top board (23) or substrate (23), image tube (33) is pushed towards the side of substrate (21) respectively, and inner flow passage is alignd with opening (30).Some fluid encapsulation material also can be inserted between pipe and substrate or the top board, to produce from managing inner fluid-encapsulated connection to passage (22).Optionally, tube portion ground or fully penetrate opening, image tube (35) pass opening (32) or pipe (34) inserts in the those widened sections (36) of openings (31).

Fig. 4 B has shown the method that multi-lumen tube (37) is connected to micro-fluid chip (20), as seen have two passages as vertical view, wherein be connected to the first passage of micro-fluid chip (20) end-opening at least one chamber (38) fluid, and at least one of other chamber is connected to second channel by the opening of a side at pipe (37), but may utilize some plugs (40) in the end-the opening part sealing.

Fig. 5 has shown the stocking system that comprises pressure structure (100).The critical piece of pressure structure (100) is to go up element (perhaps on the pressure side element) (100a), following element (perhaps fluid side element) (100b), paper tinsel or film (120) and afflux element (130).

On the pressure side element (100a) has first group of shape or geometry (101-105), and fluid side element (100b) has second group of shape or geometry (111-115), first and second groups of geometries are outside profile in the plate that constitutes main body (100a, 100b), first group of geometry of last main body roughly becomes mirror image at second group of geometry of size and dimension up and down main body.The combination internal volume of the inner volume of first group of geometry (101) and first group of geometry (102-105) is roughly the same, and accordingly, the combination internal volume of the internal volume of second group of geometry (111) and second group of geometry (112-115) is roughly the same.

On the pressure side element (100a) has the inner first pattern recess (141, see for example Fig. 7), with the adapter (311) that pump connects (310) that is connected internally to of first group of geometry (101-105), sees Figure 12.These recesses can be separately connected to adapter (311), but preferably, only one first group geometry (101-105) is directly connected to adapter (311), and first group of geometry is connected to each other by the first pattern recess.

The paper tinsel of flexible material or film (120) have been positioned on the pressure side between the element (100a) and fluid side element (100b), and wherein flexibility is interpreted as: material bending easily and not damaged, but needn't have any tangible elasticity.Film (120) has part (121-125), and its form fit is to first group and second group of geometry (101-105,111-115), and wherein shape is preferably by vacuum mo(u)lding and/or punching press or punch die formation.

Optionally, for the barometric gradient of guaranteeing the film both sides can be extruded storage compartment with fluid, in another embodiment, film (120) can comprise flexible portion, its other parts than film have more elasticity, flexible portion is between the chamber of alignment, and wherein flexible portion is suitable at least one that substantial deformation becomes two chambers being arranged on each side of flexible portion.

Element (100b, 120) is preferably gone up the edge that centers on second group of geometry (111-115) and membrane portions (121-125) and is connected by paper tinsel or film (120) being thermally welded to fluid side element (100b).But can use arbitrarily other connected mode, as bonding, Laser Welding or ultrasonic bonding.

Preferably, on the pressure side element (100a) also is connected to film (120), at itself and the surperficial facing surfaces place that is connected to fluid side element (100b), this preferably realizes by the ultrasonic bonding around edge (106,107), but also can use the method for other Connection Element arbitrarily, as bonding or laser weld.

Preferably, all fluid side geometries (112-115) are equipped with the recess (117) of second pattern, this recess (117) has and penetrates the reservoir through hole (119) of element (100b) on the pressure side, wherein align with protrusion (127) in edge (107) to the second pattern recess (117) of small part, and the second pattern recess (117) of part is positioned at second group of geometry (112-115) inboard, as schemes to go up as seen.Second group of geometry (111) has the waste material recess (116) that aligns with edge protrusion (126), wherein this waste material recess (116) has two independent parts, first's waste material recess has the first check-valves through hole (118a), and second portion waste material recess has the second check-valves through hole (118b).

The edge protrudes (126) around waste material recess (116), the first and second check-valves through holes (118a, 118b), and a plurality of valve through holes (128) are gone back through flow body side member (100b), its mode is: the edge protrudes free island portion or the connecting portion (108) that (126) comprise the flexible membrane (120) that covers second through hole (128), each connecting portion (108) covers a pair of valve through hole (128), its mode is: another of each valve through hole (128) and valve through hole (128) is paired, and connecting portion (108) produces fluid and is communicated with between them.

Afflux element (130) is being connected to element (100b) on the pressure side with film (120) opposite surfaces place.Afflux element (130) has the first afflux recess pattern (131) and the second afflux recess (133) that is formed in the surface, and wherein the first afflux recess (131) is connected to reservoir through hole (119) and valve through hole (128).Recess (131,133) can have the recess of mirror image in the surface of fluid side element (100b), when afflux element (130) and fluid side element (100b) when being connected, form passage.The first and second check-valves through holes (118a, 118b) are communicated with inside (132) fluid of the check-valves geometry (143) that wherein is furnished with check-valves (142).

Because the first afflux recess pattern (131) is connected to valve through hole (128), inside and the fluid between the second afflux recess (133) of therefore having set up second group of geometry (112-115) connect.In the same manner, the second portion of waste material recess (116) is connected in second through hole (128), and the fluid of setting up between in the inside of second pattern geometries (110) and the second afflux recess (133) connects.

Two elements (130,100b) preferably connect by ultrasonic bonding, laser weld, perhaps connect two objects with other known way arbitrarily.The first afflux recess (133) comprises fluid openings (134), perhaps in the side of element (100b) and/or (130), as schemes to go up finding, perhaps by one in one upper surface in element (100b) or (130) or the lower surface.

Valve (135) is positioned to connecting portion (108) that first end (136) pushes flexible membrane (120) downwards to element (100b) down, stops thus anyly to enter by the fluid of valve by hole (128).Second end (137) of valve (135) passes otch (138).Valve (135) is preferably made by the softish material of some cardinal principle, as rubber.When default became work, valve (135) was removed, and preferably irreversibly removes, and discharged thus by fluidic the entering of valve by hole (128).

On the pressure side element (100a), fluid side element (100b) and afflux element (130) preferably are equipped with pin and hole, and when element (100a, 100b) connected, pin fitted into corresponding hole, thereby guaranteed the abundant alignment of element, and obtained stable connection.

Fig. 6 has shown the afflux element (130) that is connected to film (120) and fluid side element (100b) and element (100a) on the pressure side.

Two check-valves through holes (118a) and (118b) between fluid be communicated with by check-valves (142) and realize, its only guarantee to flow can be from check-valves by hole (118b) to (118a), and can not be conversely.Check-valves (142) is the commercially available duckbill valve of standard preferably, but also can use other check-valves arbitrarily.Check-valves (142) is arranged in check-valves shape or the geometry (143), it has inside (132) and passes through hole (118a, 118b) fluid communication with check-valves, and check-valves (142) is positioned in the check-valves geometry (143), and its mode is: fluid only can flow to check-valves through hole (118b) through check-valves (142) from check-valves through hole (118b).

If pipe, will insert for example recess (133) as single pipe (408, see for example Figure 15), optionally can introduce through hole (144) then, wherein can insert by glue or other sticky material so that pipe is fixed in the recess.

Fig. 7 has shown the side view of the combined system of element (100a), flow element (100b) and film (120) on the pressure side.When element (100a, 100b) connected, first group of geometry (101-105) alignd with second group of geometry (111-115), formed compartment (231-235) (visible compartment (231) on Fig. 9 A and 9B).Membrane portions (122-125) is separated into (perhaps pressure) chamber (242-245) and following (perhaps fluid) chamber (252-255) with compartment (232-235), and membrane portions (122-125) adopts mode airtight or fluid-tight to make pressure chamber (242-245) and fluid cavity (252-255) sealing.

Fluid is given to the inside of fluid cavity (252-255) by the inlet (not shown), and wherein inlet is to enter first group of geometry (102-105), obtain the opening that is connected with the fluid in the external world.Inlet is preferably equipped with spin locking screw thread (lure lock taps), is used for the device of conveyance fluid is connected to fluid chamber (252-255).Subsequently, inlet is closed, and preferably by utilizing thermal weld fusing spin locking screw thread, perhaps seals them with any alternate manner that seals this opening.

Fig. 8 A is a side view, illustrates in the compartment (232) that is formed by first group of geometry (102) and second group of geometry (112), this figure also illustrates the first and second pattern recesses (117,141).Flexible membrane (120) is clipped between two elements (100a, 100b), thereby membrane portions (122) is divided into two chambeies (242) and (252) with compartment (232), as mentioned above, each chamber has leads to extraneous inlet, also as the above, chamber (242) is by the first pattern recess (141) in element (100a) surface on the pressure side, and chamber (252) are by the second pattern recess (117) in fluid side element (100b) surface.

In Fig. 8 B, compartment (232) is shown as that it is fluid-filled, and this fluid is in the fluid cavity (252) that is limited by membrane portions (122) and shape (112).The gas of picture air, perhaps some fluids are given by the first pattern recess (141) and are sent into pressure chamber (242), the barometric gradient of membrane portions (122) both sides is risen, and described barometric gradient guarantees that the fluid in the fluid cavity (252) is extruded the second pattern recess (117).

Fig. 8 C has shown identical compartment (232), and wherein because gas or liquid in charged pressure chamber (242), therefore a large amount of fluids have been extruded fluid cavity (252).

Fig. 9 A has shown the waste material compartment (231) that is used to store waste liquid, it adopts to first group of geometry (101) mode similar with the compartment (232-235) of second group of geometry (111) and designs, the waste material compartment is separated into two chambers by membrane portions (121), waste chamber (241) and empty chamber (dummychambe) (251).Preferably, waste liquid imports waste chamber (251) by waste material recess (116), as in the illustrated embodiment of the present invention, yet, also can use opposite situation.Empty chamber (241) is " virtual " then, does not produce tangible counter-pressure on membrane portions (121).

Preferably, have to freely the contacting of outside atmospheric pressure, guarantee that empty chamber (241) is in than under the lower internal pressure of waste chamber (251) by the airport (260) in first group of geometry (101).In the present embodiment, membrane portions (121) is guaranteed not have in the waste chamber (251) fluid to pass through airport (260) to be leaked in the environment, because it makes the relative sealing with empty chamber (241) of waste chamber (251).Selectively, by utilizing fluid-tight but film (261) sealing that can see through air this type of airport (260) arbitrarily can be avoided membrane portions (121), as shown in Fig. 9 B.

In certain embodiments of the invention, " void " chamber will be used for the pressure of regulating system, regulate flow rate thus.By in some way to the pressurization of second Room, can realize it.Check-valves (142) is guaranteed not reflux to turn back to the second afflux recess (133) from waste chamber (251).

Figure 10 has shown the schematic representations of base station (2), and it comprises pressure structure (100), pumping installations (202), soft copy (201), monitoring arrangement (204) and the energy (205) optionally, as battery or fuel cell.Yet, in the preferred embodiment of the invention, obtain the energy from civil power.

Interchangeable fluid section, be also referred to as wet end (200), constitute pressure structure (100), analytic unit (3), probe (5), with first and second fluid communication line road (4) and (8), but in certain embodiments of the invention, also comprise the especially pumping installations (202) and/or the energy (205).

Soft copy (201) at first is computer (203) and monitoring arrangement (204).Computer is mainly used in storage and handles measurement data, but can carry out other possibility task in addition, as the set information and the information that monitors purpose, for example patient of storage system.Monitoring arrangement (204) preferably may have the standard monitor of touch screen.

The base station further comprise all field of electronic devices known to the skilled, in this electric device needed electronics and machinery.

Pumping installations is preferably sent air or some other gas or liquor pump into compressor in the pressure chamber (242-245) with certain scalable fixed rate and pressure.Arbitrarily other conceivable pumping mode also may be used on system, as fluid (gas or liquid) being extruded machinery or the electrical system of flexible container in the pressure chamber (242-245).

Wet end (200) is connected to or inserts in the base station (2) with any-mode well known by persons skilled in the art, in the cavity in the shell (or box) that puts it into base station (2), the shaped design of its cavity becomes last element (100a) and the following element (100b) that holds connection with fixing and firm mode.

An importance of native system is that it provides following possibility: for example, the patient that wet end (200) is housed can shift between several base stations (2) of inserting wet end (200), and monitoring beginning or continuation.When moving to another place from the three unities, patient can not feel to extract probe (5) and insert the misery of new probe again, and can keep identical probe (5) and remaining wet end (200).Advantageously, wet end (200) can also comprise the device that is used to store such as the data of the set information of acquired measurement result and/or system, the wherein advantageously digital microchip of this device.Selectively, this data can directly transmission wirelessly between one base station.

The parts that another main aspect of the present invention is a wet end (200) do not comprise metal or are a spot of metal at least that it does not produce with for example MRI-scanning and disturbs.

Figure 11 has shown the feature that is particularly useful for afflux element (130), but it also can be applicable on the pressure side and fluid side element (100a, 100b).Afflux element (130) is welded to fluid side element (100b) in the following manner: any two first adjacent afflux recesses (131) are separated by welding by both sides (double welding), because this can not provide extra safety under the situation of fluid-tight in single welding.Still exist second to weld the blended chance of fluid that will prevent in the first afflux recess (131) then.

Further security feature is introduced into the preferred embodiment of system, as its on figure shown in, wherein sump pit (300) forms along the side of the first afflux recess (131).Figure has shown the cross section of afflux element (130), two first afflux recesses (131) have been shown, has sump pit (300) between them, afflux element (130) is arrived in the zone welding (301) of following element (100b) between groove (131) and sump pit (300), or connects with some alternate manners.

Sump pit (300) guarantee by not closely the fluid that leaks of welding can " be captured " by sump pit (300), and be bled into the adjacent first afflux recess (131) at it and remove in observable mode before, may be by it be discharged to the external world from system.Can discover the leakage that in afflux element (130), occurs thus, and detection wet end (200) is replaced.

Figure 12 has shown the pump connection (310) to wet end (200), and wherein air is that preferred giving delivered to the interior pressor substance of pressure chamber (242-245), but also can adopt arbitrary gas or liquid.Pump connects (310) and is shown as two parts system, wherein positive connector (311) is equipped with O shape circle (312), and this O shape circle (312) is fixed in the breach (313) in the following manner: the part of O shape circle in breach (313) top and its slightly larger in diameter in the internal diameter of negative connector (314).When positive connector (311) is positioned at negative connector (314) inside, O shape circle is guaranteed being connected of fully stable and fluid-tight with respect to the friction of the inwall of negative connector (314), realize that thus the fluid between manometer tube (315) and the pressure entrance (316) connects, air intake is communicated with recess (141) fluid and arrives the being seen pressure chamber of Fig. 8 A-8C (242-245) by the there.Positive connector (311) can be one an integrated part in the element (100a, 100b, 130), but preferably is connected to the independent parts of pressure elements (100a).

An advantage is to keep the medium of analytical equipment near patient or investigation, and wherein analytical equipment comprises analytic unit (3), the second fluid communication line road (7) and material gathering-device (5).This is because the response time of system during measuring minimized, and because general patient's comfort level, wherein only this analysis part is connected to patient, and the degree of freedom of motion only is subjected to the length restriction of first fluid communication line (4) and electrical communication circuit (8).

Figure 13 has shown the preferred embodiment of the design of analytic unit, and wherein analytic unit shell (330) is made of three parts, analytic unit outer casing bottom (330a), analytic unit cover top portion (330b) and analytic unit supporting construction (330c).System is with following principle work: reagent is added to the sample fluid that comprises related substances, to produce some detectable effects, thereby analytic unit comprises analysis micro-fluid chip (331), be also referred to as little laboratory, wherein reagent fluid is mixed into sample to obtain characterizing some materials the observing and measurable effect of concentration in fluid, and wherein effect is that optics is detectable in a preferred embodiment.

Afflux micro-fluid chip (332) distributing fluids in system is analyzed micro-fluid chip (331) such as reagent fluid is given to deliver to, and optionally, waste liquid is discharged from analytic unit.In a preferred embodiment, the afflux micro-fluid chip also perfusion of fluid is given deliver to material gathering-device (5) to inner catheter (13), and receive sample fluid from fluid conduit systems (14) backward, it is assigned to analyzes micro-fluid chip (331).

Analytic unit supporting construction (330c) is positioned between analytic unit cover top portion (330b) and the analytic unit outer casing bottom (330a), and design has the deep of adding (337).Sensor outer housing (336) comprises sensor outer housing bottom (336a) and sensor outer housing top (336b), and is arranged in and adds deep (337).Analytic unit supporting construction (330c) push fluid section (331) and (332) with the inboard opposite surfaces that adds deep (337) towards analytic unit outer casing bottom (330a), keep it to fix, advantageously, use fluid section (331,332), the roughly softish parts between analytic unit supporting construction (330c) and/or the analytic unit outer casing bottom (330a) (can be rubber blanket, rubber washer or foam).

Analytic unit supporting construction (330c) and sensor outer housing bottom (336a) equipment are fenestrate, first window (339) in the analytic unit supporting construction (330c), second window (338) with in sensor outer housing bottom (336a) is positioned to: when analytic unit is combined in a time-out, and two windows alignment.Packing ring, liner or foam (341), preferably rubber or elastomeric by between analytic unit supporting construction (330c) and sensor outer housing bottom (336a), centers on window (338,339) with relatively especially external light source sealing.The pick off (333) that is enclosed in thus between the sensor outer housing bottom (336a) and sensor outer housing top (336b) only receives the light that passes window (338,339).Slide or plate (350) can be positioned at window.

Three analytic unit housing parts (330a, 330b, 330c) preferably edgewise edge connect by ultrasonic bonding, but also can adopt other method arbitrarily, as bonding these parts.Similarly, two sensor outer housing parts (336a, 336b) preferably edgewise edge connect by ultrasonic bonding, but also can adopt other method arbitrarily, as bonding these parts.

As above described in a preferred embodiment, the measurement of material is according to optical detection, therefore sensor outer housing (336) inside that does not importantly have external light source to see through micro-fluid chip (331,332) or place pick off.Therefore, to connect be by first fluid communication line (4) to shell (330) only fluid of being designed to from the external world to the internal flow part (331,332).Only is the conductive communication circuit (8) that pick off (333) is connected to base station (2) to other extraneous connection.First and second fluid communication line roads (4,7) and electrical communication circuit (8) are equipped with plug (343,344,345) respectively, are used for sealed entry (346,347,348).

One in the major part of analytic unit is micro-fluid chip, and its execution obtains characterizing the also chemical reaction of measurable optical effect of observing of the concentration of certain material in fluid.

Figure 14 has shown the decision design of analysis micro-fluid chip (331), this design is identical with the design of general micro-fluid chip (20), have analytic substrate (370) and analyze top board (371), be surrounded by analysis vat system (372,375,377,379,381,382) therebetween.In the drawings, two parts (370,371) are not connected.Perfusion of fluid enters analysis vat (372) by the analysis chip opening of analyzing in the top board (371) (373).First reagent fluid enters analysis vat part (375) by the analysis chip opening of analyzing in the top board (371) (374), and locates to mix at mixing point (376) with perfusion of fluid.Analysis vat (372) extends to the first circuitous portion (377), locate the free mixing mutually of blended fluid at this, and arrive second mixing point (378) at it and react before, and mix with second reagent fluid that enters from analysis vat part (379) and analysis chip opening (380).Analysis vat (372) extends in the second circuitous portion (381), locate the free mixing mutually of blended fluid at this, and arrive the 3rd circuitous portion (382) at them and react before, the 3rd circuitous portion (382) aligns with window (339,338), so pick off (333) has the visual angle of observation in the detectable reaction of optics of the 3rd circuitous portion generation.First top board (371) is transparent in its zone that covers the 3rd circuitous portion at least therefore.Fluid, be waste liquid at present, leave and analyze microchip (331) by analyzing opening (383).

Figure 15 has shown the preferred embodiment of afflux micro-fluid chip (332), and it adopts the mode identical with general micro-fluid chip (20) to design, and comprises afflux substrate (400) and afflux top board (401), and these two plates (400,401) do not connect among the figure.A plurality of afflux grooves (402-407) are connected with single tube (408) fluid.Afflux groove (402-407) is connected with one group of afflux chip opening (411-413) fluid again.In illustrated embodiment of the present invention, one in the afflux groove (406) with one in the single tube (408) fluid conduit systems forward (13) that is connected to the material gathering-device (5) that is communicated with perfusion of fluid.Selectively, perfusion of fluid is all walked around analytic unit, and one in the pipe (408) is directly connected to fluid conduit systems (13) forward.

By afflux chip opening (410) and analysis chip opening (373), the afflux groove (407) in the example illustrated is at the fluid conduit systems backward (14) of material gathering-device (5) and analyze and produce fluid between the analysis vat (372) in the micro-fluid chip (331) and connect.

Afflux groove (402-407) preferably is made of the flow path in the afflux substrate (400), and as described above, this flow path aligns with mirror image flow path in the afflux top board (401).

Optionally, the fluid conduit systems forward (13) of material gathering-device (5) and/or backward fluid conduit systems (14) directly be connected to and analyze micro-fluid chip (331), wherein afflux micro-fluid chip (332) will pour into and sample fluid is assigned to and analyzes micro-fluid chip (331) and from analyzing micro-fluid chip (331) distribution.

Two micro-fluid chips (331,332) and the filter between them (420, among Figure 16 as seen) connect together, and its mode is: register is communicated with to produce fluid between the groove of two micro-fluid chips.Example system among the figure makes afflux chip opening (410) align with analysis chip opening (373) then, afflux chip opening (411) aligns with analysis chip opening (374), afflux chip opening (412) aligns with analysis chip opening (380), and afflux chip opening (413) aligns with analysis chip opening (383).

Filter can selectively be located, and such as the reference flow direction, just preceding or may be just at the second afflux recess (133) afterwards at afflux micro-fluid chip (332), preferably it must be inserted in current limiter (501) before, below describes current limiter (501).

Two micro-fluid chips preferably connect in the mode of the end to the top, wherein the relative afflux top board (401) of analytic substrate (370) is located, but optionally, its can for the end to end mode, wherein analysis and afflux substrate (370,400) are located relative to each other, perhaps push up the top mode, and wherein analysis and afflux top board (371,401) are located relative to each other, perhaps push up end mode, wherein analyze top board (371) afflux substrate (400) location relatively.

Two micro-fluid chips (331,332) connect by ultrasonic bonding, thermal weld, splicing or any alternate manner of connecting two elements.

Figure 16 has shown a connection of two openings (421,422), and wherein afflux substrate (400) is analyzed top board (371) location relatively, and filter recess or depression (423,424) form and alignment around opening (421,422).Filter (420) is positioned at and filters between depression (423,424) and two micro-fluid chips (331,332), is used for removing foul, pollutant, the microorganism of fluid and other material that may exist.Two filter depression (423,424) have increased the working region of filter.Filtering material is microporous PE S preferably, but also can the application of any suitable filter.

The optimal way of the single flow rate of regulating system is to introduce current limiter or flow restriction element in system, and wherein current limiter advantageously can be that interior cross-sectional area is significantly less than single tube (408), the first and second afflux recesses (131-133), afflux micro-fluid chip (132) and analyzes the afflux chip of micro-fluid chip (131) and the tube portion of analysis chip groove (402-407,372,375,377-379,381,382).The natural selection of this current limiting element can be the silica-based microporous pipe that can buy on the market of standard, perhaps capillary tube, capillary tube has following character: for any given pressure reduction, by selecting the capillary tube of appropriate length and diameter, flow rate can be fixed on required value.

The multiple different embodiment that insert current limiter are possible, such as their being imported in first or second afflux recess (131-133) or as shown in figure 17, limitations set (500) is introduced first fluid communication line (4), wherein current limiter (501) inserts each single tube (408), increase total flow resistance of single tube (408), reduce flow rate thus.Yet, the preferred embodiments of the present invention are, current limiter (501) is inserted in the groove of afflux microchip (332), perhaps insert in the groove of analyzing micro-fluid chip (331), as show vertical view seen in fig. 18 of micro-fluid chip (502) and groove (503), wherein current limiter (501) is arranged in groove (503) and fixing by more one or more cohesive material plugs (504), and plug (504) also is used for the mobile fluid of seal groove, forces it to pass through current limiter (501).

System in the preferred embodiment works in the following ways: the container of perfusion of fluid from base station (2) is by the forward fluid conduit systems (13) of the single tube (408) in the first fluid communication line (4) to probe (5), selectively by one in micro-fluid chip (331) or (332).In probe (5), when related substances saw through film (10) diffusion, they were collected by sample fluid.This is rich in the perfusion of fluid of material, is sample fluid now, enters the first circuitous groove (372) of analyzing micro-fluid chip (331), as previously mentioned, selectively, at first by one in the groove of afflux micro-fluid chip (332).

Sample fluid is mixed mutually with the plurality of reagents fluid subsequently.Reagent fluid from base station (2) by some single tubes (408) the first fluid communication line (4), by the opening of picture (374,380) and the slot part of picture (375,377), enter the analysis micro-fluid chip, and mix with sample fluid at the mixing point of picture (376,378).Circuitous reactive moieties (377,381) guarantees that reacting fluid fully mixes with sample fluid if having time and reacts.

Last circuity part (382) passes through the position that window (338) is surveyed at detectable optical effect by pick off (333).The data that pick off send to be measured are to base station (2), preferably by electrical communication circuit (8) or pass through wireless transmission.

Sample fluid, be waste liquid at present, leave analysis micro-fluid chip (331) by opening (383), preferably, get back to base station (2), locate it at this and be stored in certain bag, container or the chamber (231) by one in the pipe of afflux micro-fluid chip (332) and fluid communication line road (4).Optionally, the direct guiding system of waste liquid.

Base station (2) comprises can handle and store the data computing machine, preferably also comprises the monitor that is used for video data.Computer installation (2) also can adopt certain methods control pick off (333) and/or flow rate.

Fluidic flowing produced by the pumping installations (202) that is included in the base station (2), wherein the pumping installations in the preferred embodiment is the type of fluid storage in fluid bag or chamber (252-255), each described fluid bag or chamber (252-255) have at least one flexible sides or wall, with a pressure communication in the pressure chamber (232-235).Optionally, all fluid chamber (252-255) are positioned in the common pressure chamber.The inside of pressure chamber is filled the pressor substance as gas then, and when pressor substance pushed flexible sides or the relative fluid of wall, the fluid in the fluid chamber was squeezed in the fluid communication line road (4) thus.

The preferably a plurality of single flexible pipes of first fluid communication line (4) (408, see Figure 15), known as medical filling system field, and preferably, by constituting as materials such as PE, PUR, PA.Single tube (408) is assembled in by in the common big envelope or shell made as materials such as PVC, rubber, PUR.In order to ensure the correct installation of pipe, especially between system's installation period, single tube preferably can be coated different colors, may also have different external diameters, is possible with only a kind of permutation and combination of installing of guaranteeing pipe.

Figure 19 A has shown the selectivity form of the pressure structure seen in Fig. 5 and 6 for example; wherein afflux element (130) protective cowl (601) of being managed (600) and protecting tube (600) substitutes; possibly, described protective cowl (601) is fixed to element (100b) on the pressure side with pipe.Pipe substitutes at least the first and second afflux recesses (131,133), and fluid is connected to storage through hole (119).In preferred illustrated embodiment, pipe (600) is to extend to the single flexible pipe (408) that stores through hole (119) from common big envelope.

In the present embodiment, the valve bonnet element (602) that comprises check valve structure (143) is connected to element (100b) on the pressure side.Valve bonnet element (602) and on the pressure side the system of element (100b) can have recess (116,133), opening (134) and through hole (118), the system of the embodiment seen in the image pattern 5 and 6, and working in the same manner.

Figure 19 B illustrates the identical systems that Figure 19 A shows with vertical view, and wherein dotted line represents to have the rear side of the system of pipe (600) and protective cowl (601).The last front side of view comprises second group of geometry (111-115), the first pattern recess (117), it produces from second group of geometry (112-115) inner by storing the fluid connection of through hole (119) to pipe (600), waste material recess (116) and have the valve bonnet element (602) of check valve structure (143).

Figure 20 A and 20B have shown the selection form of valve (135), are particularly suited for the embodiment seen in Figure 19 A and the B.The clamping element (650) that comprises two shanks (651) and have the pivoting member (652) of press element (653) is releasably connected to the structure (654) that pipe (600) does not have protective cowl (601) to locate.Structure (654) is positioned at pipe down, and comprises the end (656) of compatible portion (655) to hold and to cooperate press element (653).In two shanks (651) each all comprises the part (657) that clamping element (650) is fastened to structure (654), and when clamping element (650) is fixed to structure (654), pipe (600), is communicated with to prevent any fluid by pipe (600) between end (656) and compatible portion (655) by pinching.When system is set to work, two shanks (651) are pressed together around pivotable member (652), shown in arrow (658) among Figure 20 B, so that they are discharged from structure (653), and clamping element (650) removes then, and the fluid in the releasing tube (600) is communicated with thus.

Claims (18)

1. analytic unit (3) that is used for the system (1) of analysing fluid, described analytic unit (3) comprises the first fluid communication line (4) that is used for base station (2) communication of fluid, the second fluid communication line road (7) with material gathering-device (5) communication of fluid, and sensing device, described sensing device is suitable for providing the data of content of material in the expression fluid.

2. analytic unit according to claim 1, wherein, the flow resistance that described first fluid communication line (4) has is in fact less than the described second fluid communication line road (7).

3. analytic unit according to claim 1, wherein, described first fluid communication line (4) is shorter than the described second fluid communication line road (7) in fact.

4. according to claim 2 or 3 described analytic units, wherein, described sensing device comprises analyzes micro-fluid chip (331) and optical pickocff (333), and described analysis micro-fluid chip (331) has the analysis vat system that comprises at least one analysis vat (372,375,377,379,381,382).

5. analytic unit according to claim 4, wherein, at least one analysis vat (372) of described analysis micro-fluid chip (331) comprises circuity part (377,381,382).

6. analytic unit according to claim 5, wherein, at least a portion (382) of described analysis vat system (372,375,377,379,381,382) is covered by transparent top (371).

7. according to each the described analytic unit in the aforementioned claim, further comprise afflux micro-fluid chip (332) with afflux chip groove (402-407).

8. analytic unit according to claim 7, wherein, at least one in the described afflux chip groove (402-407) is communicated with described first fluid communication line (4) fluid.

9. according to claim 7 or 8 described analytic units, wherein, at least one in the described afflux chip groove (402-407) is communicated with at least one analysis vat (372,375,377,379,381,382) fluid of described analysis micro-fluid chip (331).

10. analytic unit according to claim 9, wherein, described afflux micro-fluid chip (332) comprises at least one afflux chip opening (410-413), described at least one afflux chip opening (410-413) aligns with at least one analysis chip opening (373,374,380,383) of described analysis micro-fluid chip (331), and the connection of the fluid between the groove in the chip is provided thus.

11. analytic unit according to claim 10 further comprises the filter (420) that is arranged between described afflux micro-fluid chip (332) and the described analysis micro-fluid chip (331).

12. according to claim 10 or 11 described analytic units, wherein, at least one in the described afflux chip opening (410-413,373,374,380,383) has depression (424).

13. analytic unit according to claim 10, wherein, in described analysis micro-fluid chip (331) and the described afflux micro-fluid chip (332) at least one comprises at least one groove (402-407,372,375,377,379,381,382), and the slot part of the flow resistance of the increase of providing is provided described at least one groove.

14. analytic unit according to claim 13, wherein, the flow resistance of described increase is provided by a capillary (501), and described capillary tube (501) is arranged among of described at least one groove (402-407,372,375,377,379,381,382).

15. according to any described analytic unit in the aforementioned claim, wherein, at least one in the described first and second fluid communication line roads (4,7) provides described analytic unit (3) to described base station (2) and/or removably connecting to described material gathering-device (5).

16. according to any described analytic unit in the aforementioned claim, it is suitable for receiving pressure fluid via described first fluid communication line (4).

17. according to any described analytic unit in the aforementioned claim, it is made by one or more material monolithics that allow NMR (Nuclear Magnetic Resonance)-imaging scanning.

18. any described analytic unit according in the aforementioned claim further comprises data processing equipment (203), described data processing equipment is suitable for deal with data so that the information about content of material in the fluid to be provided.

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