CN108982604A - The portable monitoring system of analyte in a kind of dynamic METHOD FOR CONTINUOUS DETERMINATION body fluid - Google Patents
The portable monitoring system of analyte in a kind of dynamic METHOD FOR CONTINUOUS DETERMINATION body fluid Download PDFInfo
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- CN108982604A CN108982604A CN201810880446.6A CN201810880446A CN108982604A CN 108982604 A CN108982604 A CN 108982604A CN 201810880446 A CN201810880446 A CN 201810880446A CN 108982604 A CN108982604 A CN 108982604A
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- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N27/00—Investigating or analysing materials by the use of electric, electrochemical, or magnetic means
- G01N27/26—Investigating or analysing materials by the use of electric, electrochemical, or magnetic means by investigating electrochemical variables; by using electrolysis or electrophoresis
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
- B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
- B01L3/00—Containers or dishes for laboratory use, e.g. laboratory glassware; Droppers
- B01L3/50—Containers for the purpose of retaining a material to be analysed, e.g. test tubes
- B01L3/502—Containers for the purpose of retaining a material to be analysed, e.g. test tubes with fluid transport, e.g. in multi-compartment structures
- B01L3/5027—Containers for the purpose of retaining a material to be analysed, e.g. test tubes with fluid transport, e.g. in multi-compartment structures by integrated microfluidic structures, i.e. dimensions of channels and chambers are such that surface tension forces are important, e.g. lab-on-a-chip
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- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N27/00—Investigating or analysing materials by the use of electric, electrochemical, or magnetic means
- G01N27/26—Investigating or analysing materials by the use of electric, electrochemical, or magnetic means by investigating electrochemical variables; by using electrolysis or electrophoresis
- G01N27/28—Electrolytic cell components
- G01N27/30—Electrodes, e.g. test electrodes; Half-cells
- G01N27/327—Biochemical electrodes, e.g. electrical or mechanical details for in vitro measurements
- G01N27/3271—Amperometric enzyme electrodes for analytes in body fluids, e.g. glucose in blood
-
- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N27/00—Investigating or analysing materials by the use of electric, electrochemical, or magnetic means
- G01N27/26—Investigating or analysing materials by the use of electric, electrochemical, or magnetic means by investigating electrochemical variables; by using electrolysis or electrophoresis
- G01N27/28—Electrolytic cell components
- G01N27/30—Electrodes, e.g. test electrodes; Half-cells
- G01N27/327—Biochemical electrodes, e.g. electrical or mechanical details for in vitro measurements
- G01N27/3275—Sensing specific biomolecules, e.g. nucleic acid strands, based on an electrode surface reaction
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
- B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
- B01L2200/00—Solutions for specific problems relating to chemical or physical laboratory apparatus
- B01L2200/10—Integrating sample preparation and analysis in single entity, e.g. lab-on-a-chip concept
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
- B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
- B01L2300/00—Additional constructional details
- B01L2300/08—Geometry, shape and general structure
- B01L2300/0861—Configuration of multiple channels and/or chambers in a single devices
Abstract
The present invention provides a kind of monitoring system of analyte in dynamic METHOD FOR CONTINUOUS DETERMINATION body fluid, and the monitoring system includes microdialysis probe implanted device, chip measuring device and system control and display device.Micro-biochip structure of the invention declines the preparation difficulty of chip, prepares the circulation type micro-fluid chip that both ends band stretches out column, so that integrated connection is easy, airtightness is more preferable.Circulation systems flow control further introduces low flow velocity control assembly on the basis of chip electrode structure control before in monitoring system of the present invention, so that system flow rate control is lower, the requirement that subcutaneous length is implanted into microdialysis probe film is reduced, to reduce the requirement to implantation personnel.Flow speed stability control is also more preferable.
Description
Technical field
The present invention relates to clinical samples to monitor field, just more particularly, to analyte in a kind of dynamic METHOD FOR CONTINUOUS DETERMINATION body fluid
Take formula monitoring system.
Background technique
Blood glucose variability is the factor of an effective prediction diabetic complication risk.The dynamic blood of continuous real-time display
Glucose monitor (CGM) can improve significantly the blood glucose variability of diabetic and preferably control their blood glucose.Glycemic control
Difference will lead to more diabetic complications, depression, negative feeling and worse quality of life.A large amount of data are shown in real time
CGM improves the important clinical index of diabetic as reduced HbA1c value significantly, reduces glucose variability and hypoglycemia
Frequency reduces the duration of high or low blood glucose.It is related concurrent that the improvement of these important clinical indexs reduces diabetes
The risk of disease improves the quality of life of diabetic.CGM be in diabetes management newest and most important technology into
Exhibition.The method that routine use CGM can thoroughly improve assessment at present and management blood glucose.Due to hyperglycemia insufficient treatment and
The occurrence risk of related complication is more prevalent, more urgent to the needs of CGM.Compared with intermittence SMBG test, CGM can make
Diabetic more effectively controls and adjusts their insulin, and can greatly help doctor and patient to find most preferably
Clinical treatment.
Currently, being to be implanted into the dynamic blood based on subcutaneous needle-like electrochemical sensor in the leading products of CGM in the market
Glucose monitor system (CGMS), such asPLUS,Dexcom G4TM,REAL-Time,
FreeStyle Navigator II, these CGMS are catalyzed in tissue fluid by being implanted into subcutaneous needle-like electrochemical sensor
Glucose generates oxidation current, and the size of the oxidation current is directly proportional to concentration of glucose.When finger blood calibration value is entered instrument
Afterwards, the calibration value of current value and input when CGMS is calibrated automatically according to implanted sensor and storage relevant calculation within the system
Current value is converted to blood glucose value at that time by method.The sensor of such monitoring system can work in vivo a couple of days, can after being finished
It is replaced by user.But such sensor to implant can be faced with the problem of human body rejects to allogene, be easy by body
Interior substance deposits rapidly/it is adhered to implant site, thick capsule is formed by scar tissue, wraps up the sensor of implantation, seriously
Influence its performance, especially accuracy.After implant site stations subcutaneous time enough, damage location can undergo repair process
Connective layer is formed afterwards, and sensor is stable in the process just to need certain preheating time, thus subcutaneous plant most of at present
The CGMS for entering sensor requires longer preheating time (being greater than 2 hours).In addition, body injury repair process is a large amount of
Cellular activity will affect the glucose and oxygen concentration of implanting tissue, and is wrapped in the scar tissue outside implanted sensor and is formed
Capsule thickness can change with Implantation Time, influence transmission rate of the glucose into sensor in tissue fluid, cause to be implanted into
Sensor can not contact normal tissue liquid, thus can not real-time detection/reflection blood sugar concentration and variable condition.Thus such biography
Sensor a few houres just need to calibrate once, and the data that otherwise will lead to monitoring do not have any clinical meaning.These reasons result in
Such system is difficult to hospital emergency room and intensive care unit (ICU).Because the two departments require at once accurately
Continuous monitoring to blood glucose, and the result for relying on monitoring gives corresponding accurately insulin dose to reduce the disease incidence of patient
And the death rate.
It is most of to be implanted into subcutaneous sensor and be to rely in tissue fluid oxygen as electron acceptor, and oxygen in tissue fluid
The concentration of gas is (150mmHg) of the concentration far below oxygen at atmospheric pressure, and the concentration of some tissue oxygen gas is even only
40mmHg.This limitation shows the concentration of the oxygen in tissue fluid an order of magnitude lower than the concentration of glucose under physiological condition.
This is a very serious defect for the electrochemical sensor of embedded type.This kind of sensor necessarily by due to oxygen content with
And error detection result caused by oxygen and glucose ratio fluctuation.Such mistake include sensor response signal change and
Detect online reduction.In order to which sensor is in the applicability of low oxygen concentration, the sensor detection electric current of preparation and detection spirit
Sensitivity is all modulated relatively low.But this is unfavorable for the batch system of very important hypoglycemia early warning sensitivity and sensor
It is standby.Sensors with auxiliary electrode mostly uses the wires such as Pt or Pt-Ir as basal electrode and to oxygen/hydrogen peroxide Catalytic Layer,
Such Catalytic Layer catalytic potential is excessively high (such as 0.6V), causes common electroactive chaff interferent to influence big, anti-interference is poor.Finally, should
Class CGMS is connect by line with the electronic device of patch on the skin by implanted sensor and the display control instrument of wireless receiving
Communication is coupled.The personal electronics that this design may cause the line error of sensor and personal electronic device and often occur fills
Set the display control instrument communication lost contact with wireless receiving.
CGMS that is another kind of commercial but not being ordinary consumption product is GlucoDay, which is that an about 25mm long is saturating
The ductule operation implantation subcutaneous tissue for analysing film, drives isotonic perfusion liquid by the pump of system, flows through the dialysis membrane of implantation, and will
The tissue fluid dialysed into perfusion liquid takes back external (taking the glucose of in-vivo tissue liquid in vitro to), with positioned at external glucose
Glucose in sensor measurement dialyzate, and it is converted into intracorporal blood sugar concentration.In vitro due to sensor, without implant
The problem of human body of inner sensor rejects to allogene, therefore primary calibration and accuracy is only needed to be higher than sensor in vivo
CGMS.But the main problem of the system includes: to lead to implanting tissue wound since the dialysis probe film used is too long (25mm)
Or inflammation causes signal drift, and the site of probe implantation may also influence testing result；The dialysis probe of 25mm long is only
It can be implanted by surgical, it has not been convenient to which ordinary user directly uses and (limits using market).In addition, excessively high (such as 10 μ of flow velocity
L/min), the dialysis rate of recovery is low, it is desirable that the sensitivity (especially to hypoglycemia) of sensor is high and base current it is very low (as <
1nA), the perfusion liquid volume needed is also larger (leading to systems bulky, volume is big)；For the sensitivity for improving sensor, use
Prussian blue electron mediator, but this has the long-term detection stability of sensor and seriously affects.The CGMS of Roche company
Similar to GlucoDay, but preheating time long needs 12 hours.Slower additionally, due to the flow velocity of perfusion liquid, intrinsic is stagnant
The time is 31 minutes afterwards.
In addition some vitro systems will be pumped into external Portugal from the sub-fraction of the blood extracted in vivo by multiple
Grape sugar sensor, carries out the measurement of blood glucose；Meanwhile body is sent back to after cleaning the overwhelming majority of the blood of extraction by cleaning device
It is interior.Such system be it is extremely complex and dangerous, and expensive, so that it is difficult to apply and must be quickly arranged or simple and crude
Working environment in, such as family healthcare or emergency ward.
Summary of the invention
To solve the above-mentioned problems, the present invention provides a kind of monitoring system of analyte in dynamic METHOD FOR CONTINUOUS DETERMINATION body fluid, institute
Stating monitoring system includes: microdialysis probe implanted device, including probe fixation member, puncture booster parts, the probe are fixed
Component is removably connect with the puncture booster parts, and the puncture booster parts can force probe fixation member court
It is moved to puncture position, so that in microdialysis probe implantation destination organization；Chip measuring device, the chip measuring device is successively
Including perfusion liquid bag, micro-fluid pump, low flow velocity control assembly, micro-fluid measurement chip and waste liquid collecting bag, lead between each section
Cross microtubular connection；The fluid inlet of the microdialysis probe and outlet respectively with the fluid outlet of low flow velocity control assembly and micro-
The seamless matching connection by microtubular or directly of the fluid inlet of fluid measurement chip；It is described with system control and display device
System control and display device control the micro-fluid pump and the micro-fluid measurement chip, and the data that real-time collecting is measured
Stored, and/or analyzed processing, and/or display.
In one embodiment, the probe fixation member includes fixed plate body and probe fixing piece, and the probe is solid
Determining part includes steel needle, and the probe fixing piece passes through the steel needle when in use and installs fixed microdialysis probe, and the probe is solid
Determine part position adjustably to connect with the fixed plate body, when being punctured, the puncture booster parts can force described
Probe fixation member is moved towards puncture position, so that in microdialysis probe implantation destination organization.
In one embodiment, there is lock hole, the puncture booster parts have and can rise and fall on the fixed plate body
Locking hook, when the probe fixation member and the punctures booster parts assembling when, the locking hook can be flush-mounted in
In the lock hole, so that the probe fixation member is connected as one with the puncture booster parts.
In one embodiment, the fixed plate body has Z-shaped slot, and the Z-shaped slot has the first slot parallel to each other
Road, the second conduit, distance of first conduit apart from the steel needle are less than distance of second conduit apart from the steel needle,
The probe fixing piece can slide in the Z-shaped slot, and can be locked in first conduit, and/or, it can be by
It is locked in second conduit.
In one embodiment, the probe fixing piece is equipped with Double-face adhesive scholar away from the side of the fixed plate body.
In one embodiment, the puncture booster parts include pull rod, sleeve, spring, mounting blocks, the mounting blocks
One end equipped with the pull rod, the spring is in the mounting blocks and sleeve is deposited between the spaces in the axial direction, and the drawing
Bar, sleeve, spring coaxial package, when the pull rod and the sleeve generate puncture on direction when moving toward one another, the bullet
Spring can be compressed.
In one embodiment, the sleeve has toward its inside away from probe fixation member one end and extends
Annular boss, the pull rod far from the probe fixation member one end be equipped with hook, when the pull rod is backwards to the probe
When fixation member moves, the hook can be connected on the annular boss, so that the spring is maintained at compressive state；It is described
Pull rod also has the button that can bounce pressure, and when the button is depressed, the button can be such that the hook is detached from institute
State annular boss.
In one embodiment, the implanted device further includes that tail is stifled, and the tail is stifled to be set to the sleeve away from institute
State probe fixation member one end.
In one embodiment, the sleeve is equipped with card-bit part, and/or, the tail is blocked equipped with card-bit part.
In one embodiment, the micro-fluid measurement chip includes: circulation type micro-fluid chip, and the circulation type is micro-
It successively include fluid flows in pipes, micropore, microchannel, sensing chamber, microchannel, liquid storage tank and fluid outflow in fluid chip main body
Pipeline forms a complete fluid passage；The fluid flows in pipes and some each stretching institute of fluid outflow pipeline
It states except circulation type micro-fluid chip main body；Thin film bio sensor, the thin film bio sensor includes working electrode, to electricity
Pole, reference electrode, the engagement pad for connecting multiple electrodes with instrument outside microchip, the company of connection electrode and engagement pad
Line has the electrode dielectric layer with the matched insulating layer pattern aperture of electrode for the casting lug thereon of inserting instrument socket, described exhausted
The aperture of edge layer pattern and each electrode surface form groove；With the circulation type micro-fluid chip and the thin film bio sensor group
It dresses up the micro-biochip, with serial or parallel connection/series connection and parallel form in the sensing chamber, is embedded in one or more thin
Film biosensor continuously monitors body fluid so that the total surface of the thin film bio sensor of insertion is contacted with the body fluid flowed through
In substance.
In one embodiment, the thin film bio sensor is prepared and/or described by silk-screen printing technique
Circulation type micro-fluid chip is prepared by integrated injection molding method.
In one embodiment, the circulation type micro-fluid chip and the thin film bio sensor are respectively around distinguished
At least one abnormity to match is set, in order to combine installation between the two.
In one embodiment, the circulation type micro-fluid chip includes more than two sensing chamber, in thin film bio
There is the working electrode to match with sensing chamber quantity in sensor.
In one embodiment, the working electrode is the round single electrode or microelectrode array that diameter is less than 2mm；
The material of preparation work electrode is Pt, Pd, Rh or Ru；And/or the reference electrode is that size is less than 3mm2Circular work
The endless belt of electrode, the material for preparing reference electrode is Ag or/and Ag/AgCl；And/or described is that size is less than 3mm to electrode2The endless belt around working electrode；Preparation is Au, Pt, Pd, Rh, Ru or C to the material of electrode.
In one embodiment, the substance in the body fluid be blood glucose, lactic acid, oxygen, pH value, hematocrit and/
Or electrolyte.
In one embodiment, low flow velocity control assembly can be the capillary of different length or internal diameter, preferred length
Less than 2cm, capillary of the internal diameter less than 50 μm.
In one embodiment, the microtubular length and internal diameter of connection microdialysis probe outlet and micro-fluid measurement chip
As small as possible, to reduce the influence of dead volume, such as length is less than 2cm, and internal diameter is less than 0.1mm.
In one embodiment, perfusion liquid bag and waste collection band area are less than 15cm2, volume is less than 10mL.
In one embodiment, perfusion liquid bag and waste liquid collecting bag are detachable device, in order to the longer time
Body fluid analysis object detection requirement.
In one embodiment, the perfusion liquid in perfusion liquid bag is meet subcutaneous tissue liquid composition and osmotic pressure slow
Rush solution, preferably Dulbecco ' s physiological buffer or Ringer ' s physiological buffer.
In one embodiment, the monitoring system further includes the system control and the wired or wireless company of display device
The data processing and transmission terminal equipment connect.
In monitoring system of the present invention circulation systems flow control on the basis of chip electrode structure control before more into
One step introduces low flow velocity control assembly, so that system flow rate control is lower, the long-play flow speed stability control of system
More preferably.On the one hand flow control component of the invention can reduce system in a timing by flow control less than 3 μ L/min
The interior demand to perfusion liquid is conducive to the miniaturization of instrument, and on the other hand low flow velocity reduces system and visits to microdialysis
The requirement of needle film length is advantageously implemented surgical procedure of the easy implant procedure without health care professional of probe.Its
It is secondary, since dependence of the whole flow velocity to chip structure reduces, so that the preparation difficulty of chip declines, fluid stream can be prepared
Enter the structure except pipeline and some each stretching circulation type micro-fluid chip main body of fluid outflow pipeline, so that whole
Connection is easy, and airtightness is more preferable；More make greatly reducing to thickness of electrode for thin film bio sensor, this reduction is conducive to thin
The large scale preparation of film biological sensor electrode.Allow micro-fluid measurement chip using silk-screen printing technique, increases electricity
The convenience of pole preparation and the scale for increasing electrode preparation；In the screen printing process by the utilization of solidified paint, may be implemented
Electrode prepares high reproducibility.For this kind of technique compared to sputtering electrode technique, cost is small, and preparation is easily and fast.
In addition, using microdialysis probe implanted device in the present invention, the probe fixation member is used to visit microdialysis
Needle is fixed, and is connected as one the microdialysis probe with the probe fixation member, and the puncture booster parts are used
In forcing the probe fixation member that the steel needle that carry microdialysis probe is driven to move along direction is punctured, when specifically used
When, microdialysis probe is put into the steel needle of the probe fixation member, thus realize the accurate puncture implantation of microdialysis probe,
And the firmly problem of non-uniform for manually forcing implantation can be prevented, improve the working efficiency of implantation work；In addition, due to described
Probe fixing piece is adjustably connect with the fixed plate body position, so as to realize after implantation, by the probe
Fixing piece is adjusted to the position far from implantation point, only retains microdialysis probe film layer at this time subcutaneous, this is conducive to be subsequent
Operation provides necessary operating space, under certain conditions, due to the probe fixation member, punctures between booster parts
Detachable structure can directly remove the probe fixation member, puncture power-assisted portion in the case where not needing aforementioned device
Part all can or even directly abandon processing；Using aforementioned device, general medical staff be can be operated, for the behaviour of medical staff
It is lower to make skill requirement.
Detailed description of the invention
It in order to more clearly explain the technical solutions in the embodiments of the present application, below will be to needed in the embodiment
Attached drawing is briefly described, it should be apparent that, the accompanying drawings in the following description is only some embodiments as described in this application, right
For those of ordinary skill in the art, without creative efforts, it can also be obtained according to these attached drawings
Its attached drawing.
Fig. 1 is the schematic perspective view of the microdialysis probe implanted device of the embodiment of the present invention；
Fig. 2 is the schematic diagram of the section structure of Fig. 1；
Fig. 3 is the schematic diagram of the section structure at another visual angle of Fig. 1；
Fig. 4 is the circulation type micro-fluid chip schematic diagram of the single sensing chamber of the application；
Fig. 5 is the electrode group and its expanded schematic diagram of the single sensor of the application；With
Fig. 6 is the double-sided adhesive schematic diagram of single sensing chamber in the embodiment of the present application.
Specific embodiment
In order to make art technology field personnel more fully understand the technical solution in the application, below with reference to embodiment pair
The present invention is described further, it is clear that described embodiments are only a part of embodiments of the present application, rather than whole realities
Apply example.Based on the embodiment in the application, those of ordinary skill in the art are obtained without making creative work
All other embodiment, shall fall within the protection scope of the present application.With reference to the accompanying drawings and embodiments to the present invention make into
The description of one step.
The portable monitoring system of analyte in embodiment one, dynamic METHOD FOR CONTINUOUS DETERMINATION body fluid
The portable monitoring system of analyte is for continuously monitoring in body fluid in dynamic METHOD FOR CONTINUOUS DETERMINATION body fluid of the invention
It is each in various analytes, such as blood glucose, lactic acid, sodium ion, calcium ion, magnesium ion, chloride ion, bicarbonate ion and body fluid
Kind protein etc..
The portable monitoring system of analyte includes following subdivision in dynamic METHOD FOR CONTINUOUS DETERMINATION body fluid of the invention: micro-
Dialysis probe implanted device, chip measuring device and system control and display device.In some embodiments, of the invention
The portable monitoring system of analyte can also include data processing and transmission terminal equipment in dynamic METHOD FOR CONTINUOUS DETERMINATION body fluid, it can
To be mobile phone, computer or other electronic equipments etc..
Embodiment two, microdialysis probe implanted device
In conjunction with referring to shown in Fig. 1 to 3, according to an embodiment of the invention, a kind of microdialysis probe implanted device is provided, including
Probe fixation member 11 punctures booster parts, and the probe fixation member 11 is removably connect with the puncture booster parts,
The probe fixation member 11 includes fixed plate body 111, probe fixing piece 112, and the probe fixing piece 112 includes steel needle 13,
The probe fixing piece 112 installs fixed microdialysis probe 131, the probe fixing piece by the steel needle 13 when in use
112 positions are adjustably connect with the fixed plate body 111, and when being punctured, the puncture booster parts can force institute
Probe fixation member 11 is stated to move towards puncture position.Probe fixation member 11 described in the technical solution is used for by described
Microdialysis probe 131 is fixed in steel needle 13, and the microdialysis probe 131 is made to be connected as one with the probe fixation member 11
Body, the puncture booster parts are for forcing the probe fixation member 11 to drive microdialysis probe 131 along puncture direction
Movement, when specifically used, microdialysis probe 131 is put into the steel needle 13, thus realize the accurate puncture implantation of probe,
And the firmly problem of non-uniform for manually forcing implantation can be prevented, improve the working efficiency of implantation work；In addition, due to described
Probe fixing piece 112 is adjustably connect with 111 position of fixed plate body, so as to realize after implantation, by institute
It states probe fixing piece 112 to adjust to the position far from implantation point, only retains microdialysis probe film layer at this time subcutaneous, this is conducive to
Necessary operating space is provided for subsequent operation, under certain conditions, due to the probe fixation member 11, punctures power-assisted
Detachable structure between component can directly remove the probe fixation member in the case where not needing aforementioned device
11, booster parts are punctured or even directly abandon processing；It is general to cure using the microdialysis probe implanted device of the technical program
Shield personnel can be operated, and the operative skill of medical staff be required lower.
As the probe fixation member 11, a kind of specific embodiment of puncture booster parts connection, it is preferable that described
There is lock hole 114, the booster parts that puncture have the locking hook 121 that can be risen and fallen, when the probe on fixed plate body 111
When fixation member 11 and the puncture booster parts assemble, the locking hook 121 can be flush-mounted in the lock hole 114,
So that the probe fixation member 11 is connected as one with the puncture booster parts.The technical solution using buckle by the way of into
Row, it is simple and convenient, further increase the efficiency of implantation work.
Preferably, the fixed plate body 111 has Z-shaped slot 113, and the Z-shaped slot 113 has the first slot parallel to each other
Road, the second conduit, distance of first conduit apart from the steel needle 13 are less than second conduit apart from the steel needle 13
Distance, the probe fixing piece 112 can slide in the Z-shaped slot 113, and can be locked in first conduit,
And/or it can be locked in second conduit.Specifically, latched position can be realized by the way of clamping, more into one
Step, for the probe fixing piece 112 when sliding into second conduit, the cell wall of second conduit is equipped with elastic card
The probe fixing piece 112 is adjusted to horizontal position by vertical position by buckle structure, then passes through the elastic-buckle structure for institute
It states probe fixing piece 112 and is locked in horizontal position, it is further preferable that the upper surface of the probe fixing piece 112 in horizontal position
The Z-shaped slot can be hidden in lower than the upper surface of the fixed plate body 111 namely the probe fixing piece 112 of horizontal position
In second conduit.
Preferably, the probe fixing piece 112 is equipped with Double-face adhesive scholar, double-sided adhesive away from the side of the fixed plate body 111
It is the back side for being attached to fixed plate body 111, is the movement for preventing it；112 relative movement is that have the fixation of buckle.More into one
Step, the bonding area of the Double-face adhesive scholar is not more than 5cm2, this aspect can be convenient for the microdialysis probe implanted device
Miniaturization Design, on the other hand can then guarantee comfort of the sufferer after microdialysis probe implantation, specifically, when described viscous
When veneer product is excessive, the skin contact area of adhesive surface and sufferer implant site is excessive, this can stimulate sufferer in a way
Skin bring discomfort to sufferer.The glue of adhesive bandage formula can be selected in the alite paste of the Double-face adhesive scholar, in terms of material preferably
The medical material non-stimulated to skin, such as non-woven fabrics, plastics and rubber, wherein plastics can be PE, PTFE, PES, PU, doctor
Treat grade PVC etc.；Rubber can be silicon rubber etc..The Double-face adhesive scholar can be fixed on the fixation by hot pressing or gluing
The side of plate body 11.
As a kind of specific embodiment for puncturing booster parts, it is preferable that the puncture booster parts include
Pull rod 122, sleeve 123, spring 124, mounting blocks 128, the mounting blocks 128 are equipped with one end of the pull rod 122, the spring
124 deposit between the spaces in the mounting blocks 128 with sleeve 123 in the axial direction, and the pull rod 122, sleeve 123, spring
124 coaxial packages, when the pull rod 122 and the sleeve 123 generate puncture on direction when moving toward one another, the spring
124 can be compressed.At this point, carrying out forcing implantation to the steel needle 13 by the compression prestress of the spring 124, further
It ensure that the uniformity of force, further, by selecting the spring 124 of different-stiffness that can enhance different implantation objects
Stress adaptability.
A kind of stable specific embodiment of compressive state is realized as the guarantee spring 124, it is preferable that the sleeve
123 have the annular boss 14 extended toward its inside away from described 11 one end of probe fixation member, and the pull rod 122 is separate
One end of the probe fixation member 11 is equipped with hook 15, when the pull rod 122 is moved backwards to the probe fixation member 11,
The hook 15 can be connected on the annular boss 14, so that the spring 124 is maintained at compressive state；The pull rod 122
Also there is the button 125 that can bounce pressure, when the button 125 is depressed, the button 125 can make the hook 15 de-
From in the annular boss 14, as a kind of specific embodiment of the button 125, for example, in the button 125 towards institute
The side setting reset spring 1251 of pull rod 122 is stated, the reset spring 1251 is then sleeved on the guide post that the button 125 has
On, the axial ends of reset spring 1251 is connected between the button 125 and the inner wall of the sleeve 123, the button 125
It is flexibly connected with the sleeve 123, resets and realized by the reset spring 1251.
Certainly the implanted device is necessary artificial auxiliary there is still a need for carrying out during carrying out specific implant procedure
It helps, for example, needing operator to hold the force pull rod 122 forces compression of spring 124 etc., puncture angle selection also has
Conducive to the efficiency for promoting implantation work, in order to improve the angle accuracy for puncturing implantation, while puncture angle also can be made more
Rationally, it is preferable that the sleeve 123 has the extension board 127 extended towards 11 side of probe fixation member, the extension
The plate face of plate 127 and puncture direction there is the first included angle A, A≤45 ° such as can be 45 °, more preferably can choose for
28 °, puncture angle, which is in a more appropriate range, to be guaranteed to the restriction of A at this, it will not be too small to plant due to A value
Entering operation makes troubles.
The microdialysis probe implanted device further includes tail stifled 129, and the tail stifled 129, which is set to the sleeve 123, to deviate from
Described 11 one end of probe fixation member, to prevent pull rod 122 and/or spring 124 in the sleeve 123 from deviating from.
As described above, the steel needle 13 needs to match use, institute with the microdialysis probe 131 in the specific use process
It is often longer to state microdialysis probe 131, when in use, if not carrying out fixation appropriate to it, will seriously affect puncture implantation work
The working efficiency of work, it is therefore preferred that the sleeve 123 is equipped with card-bit part 126, and/or, the tail stifled 129 is equipped with card
Position part 126, the card-bit part 126 can be made of having reeded sheet body, and the microdialysis probe 131 can be flush-mounted in institute
It states in groove.
13 model of steel needle is preferably smaller than No. 22 steel needles, and length is preferably smaller than 10mm, such as can be 5mm, preferably
Less than 3mm.
Steel needle 13 by any bio-compatibility and can have the material of mechanical strength to be made, such as stainless steel, titanium and titanium
Alloy, silicon and its compound, tungsten alloy, plastics, ceramics etc.；As a kind of mode for more saving cost, commercially available part can be used
Such as hypodermic needle, Kumetrix ' s silicon micropin.
Probe fixation member 11, puncture booster parts can be made of the material that can be used for Medical Devices, such as plastics, rubber
Glue, metal, ceramics etc., wherein plastics can be PE, PP, POM, PTFE, PES, PSU, PEEK, PC, PU and medical grade PVC etc.；
Rubber can be silicon rubber etc.；Metal can be stainless steel, titanium, titanium alloy, aluminium, aluminium alloy etc..The microdialysis probe is planted
Enter the method that device can be machined or mold manufactures to be manufactured.
Embodiment three, chip measuring device
Chip measuring device successively include perfusion liquid bag, micro-fluid pump, low flow velocity control assembly, micro-fluid measurement chip and
Waste liquid collecting bag；It is connected between each section by microtubular.
The fluid inlet of microdialysis probe 131 and outlet are surveyed with the fluid outlet of low flow velocity control assembly and microfluid respectively
The fluid inlet for measuring chip is connected by microtubular or directly seamless matching.The fluid outlet and waste liquid of micro-fluid measurement chip are received
The fluid inlet for collecting bag is connected by micro-pipe road or directly seamless matching；The fluid outlet of perfusion liquid bag and the fluid of micro-fluid pump
Entrance seamless matching connection, the fluid outlet of micro-fluid pump and fluid inlet of low flow velocity control assembly by micro-pipe road or directly
It is connected by micro-pipe road or directly seamless matching.Each pair of matched outlet is fixed together respectively with entrance with glue, guarantees institute
There is connection place connection dead volume minimum.The various pieces of chip measuring device are successively connected with each other perforation, form a complete stream
Body access.
Example IV, micro-fluid measurement chip
Referring to fig. 4 to Fig. 6, micro-fluid measurement chip include circulation type micro-fluid chip 21, thin film bio sensor 22 with
And the thin layer double-sided adhesive 23 with matched patterns aperture.
Referring to fig. 4, in one embodiment, the microfluidic circuitry of circulation type micro-fluid chip 21 includes following portion
Point: fluid flows in pipes 211, micropore 212, microchannel 213, sensing chamber 214, microchannel 215, liquid storage tank 216 and fluid outflow
Pipeline 217；Wherein fluid flows in pipes 211 and some each stretching circulation type micro-fluid chip of fluid outflow pipeline 217 are micro-
Except 21 main body of fluid chip, it is connect respectively with the fluid inlet of the outlet of microdialysis probe 131 and waste liquid collecting bag.It is above-mentioned each
It is successively connected with each other perforation outside a part, forms a complete fluid passage.
In some embodiments, circulation type micro-fluid chip 21 further includes location hole 218 and 219.In some embodiment party
In formula, circulation type micro-fluid chip 21 is made up of integrated injection molding technique.In some embodiments, it is managed to flow into fluid
Road 211 and fluid outflow pipeline 217 can be distinguished in assembling, different at least provided with one around circulation type micro-fluid chip 21
Shape.
Above-mentioned various pieces need can have different size and shape, fluid flows in pipes 211 and stream according to different
Body flows out the outer diameter of 217 extension of pipeline and extension elongation can be according to the material and internal diameter of external connecting line
Adjustment.The extended conduit part of entry and exit can be smooth, be also possible to shape of threads, according to itself and external connecting line
Closed matching adjustment.The different size of size of micropore 212 is used to adjust in the flow resistance and vitro system of microfluid
Back pressure or resistance；The different length and curvature of microchannel 213 and 215 are used to adjust the flow resistance of microfluid and are in vitro
Back pressure or resistance in system；The different size of sensing chamber 214 and geometry, position and layout are embedded in sensing chamber 214 with placing
Various sizes and the thin film bio sensor of geometry match.The size of location hole and thin film bio sensor chip
At least provided with an abnormity around location hole matching and circulation type micro-fluid chip, for accurately assembling.Micro-fluidics bio core
The various geometries of the various pieces of the microfluidic circuitry of piece and surface, it is necessary to allow body fluid in microfluid biochip
Circulation is smoothly and dead volume is minimum, bubble-free.
Referring to Fig. 5, thin film bio sensor 22, thin film bio sensor 22 is usually made of following components: round
Working electrode 221, around working electrode 221 annulus type reference electrode 223, to electrode 222, multiple electrodes are connect with instrument
Engagement pad 225, it is a plurality of connection multiple electrodes and multiple engagement pads line 224, the casting lug thereon for inserting instrument socket
226。
In some embodiments, thin film bio sensor 22 further includes location hole 227 and 228.Meanwhile thin film bio passes
Sensor 22 is provided with the abnormity to match with abnormity provided around circulation type micro-fluid chip 21.
In some embodiments, the insulating layer 229 of 22 electrode of thin film bio sensor, and it is matched with multiple electrodes
Insulating layer pattern aperture 2210.
Above-mentioned each component of thin film bio sensor 22 is all carried in the main body of thin film bio sensor.
Sensing chamber 214 and insertion thin film bio sensor working electrode 221, to electrode 222, reference electrode 223
Match, and ensures the working electrode 221 being embedded in, to electrode 222, the matched total surface of reference electrode 223 connect with the body fluid flowed through
Touching, it is ensured that the various substances in continuous monitoring body fluid.
The performance of thin film bio sensor is decided by the film on working sensor electrode.Fixed a variety of different bio-sensings
On the working electrode (s, a variety of different biosensors are made in film and other different function films.For example, fixing on the working electrode (s
Glucose oxidase can be made into the biosensor of detection blood glucose；Various ion selective membranes are fixed on the electrode, can be made
Detect the ion electrode of body fluid intermediate ion concentration；Various antibody are fixed on the electrode, and various albumen in detection body fluid can be made
The electrode of matter concentration.The thickness that film is fixed by controlling, is made thin film bio sensor 22, then can be with circulation type microfluid core
Piece 21 is assembled into biochip, for continuously monitoring the analyte in body fluid.
Thin film bio sensor 22 is prepared with screen printing technique.Preparation work electrode first in thin layer plastic body substrate
221, reference electrode 223, to the substrate carbon-coating of electrode 222 and corresponding line 224 and engagement pad 226, then prepare reference
The Ag/AgCl layer of electrode 223, the corresponding line 224 of each electrode and engagement pad 226 can need choose whether to cover according to resistance
Ag/AgCl layers, the insulating layer in addition to pattern aperture and location hole finally is covered in top layer, the thickness of insulating layer can be according to sensing
The thicknesses of layers needs of device working electrode are adjusted.When insulating layer has certain thickness, at aperture pattern with each electrode
Surface forms groove.The groove can limit on working electrode sprawling for different film layers, be conducive to the preparation weight for improving sensor
Existing property.
Referring to Fig. 6, the thin layer double-sided adhesive 23 with matched patterns aperture: the part mainly by with location hole 232 and 233 and
The matched aperture pattern 232 of sensing chamber forms.The component is all carried on the carrier of thin layer double-sided adhesive.
The assembling of biochip electrode: by the circulation type micro-fluid chip 21 for being carved with fluid passage and required film is secured
Thin film bio sensor 22 adjusts thin film bio sensor 22 by design alignment, makes bio-sensing film layer downward.Due to chip
With the periphery design of biosensor substrate contraposition pore structure；Meanwhile thin film bio sensor 22 be provided with it is micro- with circulation type
The abnormity that abnormity provided around fluid chip 21 matches, convenient for quickly determining assembly orientation in an assembling process.It is circulating
Between type micro-fluid chip 21 and thin film bio sensor 22, it is put into the thin layer double-sided adhesive 23 with matched pattern aperture；It will determine
The alignment of position hole, while aperture is placed exactly in above sensing chamber.Then pressurization is fixed, the micro-fluid measurement chip assembled.?
In some embodiments, micro-fluid measurement chip can have more sensing chamber and multisensor.
The control of five system of embodiment and display device
The casting lug thereon 226 of the instrument socket of micro-fluid measurement chip is inserted into the sensor of system control and display device
Interface, the casting lug thereon of the instrument socket of micro-fluid pump are inserted into the micro-fluid pump interface of control and display device 3, system control and
Display device 3 can control micro-fluid pump and micro-fluid measurement chip, and the data of real-time collecting are stored, analyze processing and
Display.
System control and display device, drive micro-fluid pump micro-fluid measurement chip, and the analyte in body fluid will be from micro-
It penetrates into circulation systems in dialysis probe film, and is flowed through in micro-fluid measurement chip together under the flowing of perfusion liquid carrying
Electrode group contact, generates the detection signal of test analyte, then enters waste liquid collecting bag by fluid outlet.
System control and display device 3 can be used for continuously monitoring the test analyte in body fluid, collect test analyte
After real time data, the data of collection are carried out to storage, the analysis processing, display of data in real time.
When microdialysis probe film is implanted into subcutaneous tissue by microdialysis probe 131 by Hypodermic implanting device, system is controlled
After controlling micro-fluid pump and micro-fluid measurement chip with display device 3, which collects data.It is collected into
After the real time data of analysans, the data of collection are wirelessly or non-wirelessly transferred to system control in real time and display device 3 carries out
The storage of data, analysis processing, the physiologic result for showing analyte, the physiologic result of analyte for example can be the concentration of blood glucose
And variation tendency, and alarmed to patient the result for being more than given threshold range.Then result can be wirelessly or non-wirelessly transferred to
Data processing and transmission terminal equipment 4 carry out the long-term storage of data, analysis processing and display as a result.Data processing and biography
Defeated terminal device 4 can will also be uploaded in relation to data and result by internet in individual's " cloud " on the net, the authorization with patient
People shares for example such as doctor, family members, bosom friend, provides convenient, many-sided, long-term personal health information, convenient for diagnosing, treating,
Disease tracking and management.
It should be understood that the present invention disclosed is not limited only to specific method, scheme and the substance of description, because these
It is alterable.It will also be understood that purpose of the terminology used here just for the sake of the specific embodiment scheme of description, rather than
It is intended to limit the scope of the invention, the scope of the present invention is limited solely by the attached claims.
Those skilled in the art, which will also be appreciated that or be able to confirm that, uses no more than routine experiment, institute herein
The many equivalents for the specific embodiment of the invention stated.These equivalents are also contained in the attached claims.
Claims (16)
1. the monitoring system of analyte in dynamic METHOD FOR CONTINUOUS DETERMINATION body fluid, which is characterized in that the monitoring system includes:
Microdialysis probe implanted device, including probe fixation member, puncture booster parts, the probe fixation member is removably
It is connect with the puncture booster parts, the puncture booster parts can force the probe fixation member to be transported towards puncture position
It is dynamic, so that in microdialysis probe implantation destination organization；
Chip measuring device, the chip measuring device successively includes perfusion liquid bag, micro-fluid pump, low flow velocity control assembly, micro-
Fluid measurement chip and waste liquid collecting bag pass through microtubular between each section and connect；The fluid inlet of the microdialysis probe and
Outlet passes through microtubular or direct with the fluid inlet of the fluid outlet of low flow velocity control assembly and micro-fluid measurement chip respectively
Seamless matching connection；With
System control and display device, the system control and display device control the micro-fluid pump and the micro-fluid measurement
Chip, and the data that real-time collecting measures are stored, and/or are analyzed processing, and/or display.
2. monitoring system according to claim 1, which is characterized in that the probe fixation member includes fixed plate body and spy
Needle fixing piece, the probe fixing piece includes steel needle, and it is micro- that the probe fixing piece passes through the steel needle installation fixation when in use
Dialysis probe, probe fixing piece position is adjustably connect with the fixed plate body, and when being punctured, the puncture is helped
Power component can force the probe fixation member to move towards puncture position, so that in microdialysis probe implantation destination organization.
3. monitoring system according to claim 2, which is characterized in that there is lock hole on the fixed plate body, it is described to wear
Thorn booster parts have the locking hook that can be risen and fallen, when the probe fixation member and puncture booster parts assembling, institute
Stating locking hook can be in the lock hole, so that the probe fixation member is connected as with the puncture booster parts
One.
4. monitoring system according to claim 3, which is characterized in that the fixed plate body has Z-shaped slot, the Z-shaped slot
With the first conduit parallel to each other, the second conduit, distance of first conduit apart from the steel needle is less than second slot
With a distance from the steel needle, the probe fixing piece can slide track pitch in the Z-shaped slot, and can be locked in described
In one conduit, and/or, it can be locked in second conduit.
5. monitoring system according to claim 4, which is characterized in that the probe fixing piece is away from the fixed plate body
Side is equipped with Double-face adhesive scholar.
6. monitoring system according to claim 5, which is characterized in that the puncture booster parts include pull rod, sleeve, bullet
Spring, mounting blocks, the mounting blocks are equipped with one end of the pull rod, and the spring is in the mounting blocks and deposits in the axial direction with sleeve
In between the spaces, and the pull rod, sleeve, spring coaxial package, when the pull rod and the sleeve generate on puncturing direction
When moving toward one another, the spring can be compressed.
7. monitoring system according to claim 6, which is characterized in that the sleeve deviates from probe fixation member one end
With the annular boss extended toward its inside, the pull rod is equipped with hook far from one end of the probe fixation member, when
When the pull rod is moved backwards to the probe fixation member, the hook can be connected on the annular boss, so that the bullet
Spring is maintained at compressive state；The pull rod also has the button that can bounce pressure, when the button is depressed, the button energy
It is detached from the hook in the annular boss.
8. monitoring system according to claim 7, which is characterized in that the implanted device further includes that tail is stifled, and the tail is stifled
The sleeve is set to away from probe fixation member one end.
9. monitoring system according to claim 8, which is characterized in that the sleeve is equipped with card-bit part, and/or, it is described
Tail is blocked equipped with card-bit part.
10. monitoring system according to claim 1, which is characterized in that the micro-fluid measurement chip includes:
Circulation type micro-fluid chip, successively includes fluid flows in pipes in the circulation type micro-fluid chip main body, and micropore is micro- logical
Road, sensing chamber, microchannel, liquid storage tank and fluid flow out pipeline, form a complete fluid passage；The fluid flows in pipes and
Except some each described circulation type micro-fluid chip main body of stretching of the fluid outflow pipeline；
Thin film bio sensor, the thin film bio sensor includes working electrode, and to electrode, reference electrode, being used for will be multiple
The engagement pad that electrode is connect with the outer instrument of microchip, the line of connection electrode and engagement pad, for the convex of inserting instrument socket
Block out has the electrode dielectric layer with the matched insulating layer pattern aperture of electrode, the insulating layer pattern aperture and each electrode table
Face forms groove；With
The circulation type micro-fluid chip and the thin film bio sensor are assembled into the micro-biochip, the sensing chamber
In with serial or parallel connection/series connection and parallel form, be embedded in one or more thin film bio sensors so that insertion thin film bio
The total surface of sensor is contacted with the body fluid flowed through, the continuous substance monitored in body fluid.
11. monitoring system according to claim 10, which is characterized in that the thin film bio sensor passes through silk-screen printing
Prepared by technique and/or the circulation type micro-fluid chip is prepared by integrated injection molding method.
12. monitoring system according to claim 10, which is characterized in that the circulation type micro-fluid chip and the film
Respectively at least one abnormity to match is respectively set in surrounding to biosensor, in order to combine installation between the two.
13. monitoring system according to claim 10, which is characterized in that the circulation type micro-fluid chip include two with
On sensing chamber, there is the working electrode to match with sensing chamber quantity in thin film bio sensor.
14. monitoring system according to claim 10, which is characterized in that the working electrode is the circle that diameter is less than 2mm
Shape single electrode or microelectrode array；The material of preparation work electrode is Pt, Pd, Rh or Ru；And/or the reference electrode is ruler
It is very little to be less than 3mm2The endless belt around working electrode, the material for preparing reference electrode is Ag or/and Ag/AgCl；And/or it is described
It is that size is less than 3mm to electrode2The endless belt around working electrode；Preparation to the material of electrode be Au, Pt, Pd, Rh, Ru,
Or C.
15. monitoring system according to claim 1, which is characterized in that the substance in the body fluid is blood glucose, lactic acid, oxygen
Gas, pH value, hematocrit, and/or electrolyte.
16. -15 any monitoring system according to claim 1, which is characterized in that the monitoring system further include with it is described
The data processing and transmission terminal equipment of system control and the wired or wireless connection of display device.
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Cited By (1)
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| CN115260836A (en) * | 2022-09-30 | 2022-11-01 | 北京深纳普思人工智能技术有限公司 | Reference electrode silver-silver chloride conductive ink for CGM and preparation method thereof |
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