CN110057889A - The working electrode and preparation method thereof of glucose monitoring probe - Google Patents
The working electrode and preparation method thereof of glucose monitoring probe Download PDFInfo
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Abstract
This disclosure relates to a kind of glucose monitoring probe comprising working electrode, the working electrode have basal layer；Glucolase sensing layer is formed on the basal layer, can be chemically reacted with glucose；Semi-permeable membrane is formed on the glucolase sensing layer, controls the percent of pass of glucose molecule；And bio-compatible film, it is formed on the semi-permeable membrane, between the basal layer and the glucolase sensing layer, is additionally provided with the nano-particle layer of catalysis glucose response.According to the disclosure, working electrode operating voltage can reduce, reduce interference, extend the service life of glucose monitoring probe, and improve the reaction sensitivity for glucose.
Description
Technical field
This disclosure relates to glucose monitoring devices field, and in particular to a kind of working electrode and its system of glucose monitoring probe
Make method.
Background technique
Biosensor is by biomaterial, bio-derived material or bionic material and optics, electrochemistry, temperature
Degree, piezoelectricity, magnet or be micromechanics physicochemical transducer or the analytical equipment combined closely of sensing micro-system.So far
Until, the most successful biosensor of commercial is ampere meter enzymatic glucose sensor.Ampere meter enzymatic glucose sensor
The market share almost occupy current world market 85%.Ampere meter enzymatic glucose sensor is for detecting diabetes, city
Market share is bigger, reflects that suffer from person with diabetes more.
Diabetes are a series of metabolic disorder syndromes such as sugar, protein, fat, water and electrolyte, by inherent cause,
The various virulence factors such as immunologic function disorder, microorganism infection and its toxin, which act on body, leads to hypoinsulinism, pancreas islet
Element resist etc. and cause.If diabetes do not obtain good control, it is likely that some complication, such as ketosis can be caused
Acid poisoning, lactic acidosis, chronic renal failure and retinopathy.With the continuous raising of the disease incidence of diabetes, glycosuria
Disease has become worldwide public health problem.
Currently, diabetes there is no radical cure method, only control method.For diabetic, if patient is on ordinary days
Can in real time, continuously monitor glucose, preferentially can reduce and reduce the low glucose of the diabetic of insulin-dependent
The generation of the complication such as disease and high glucose disease.
In general, the monitoring needs of glucose are realized by the glucose detector in ampere meter enzymatic glucose sensor.Portugal
The sensing probe of grape sugar detection instrument generally all implants, the blood flow of concentration of glucose and surrounding in monitoring tissue liquid, newly
Concentration of glucose rate of change in old metabolic rate and blood vessel.Studies have shown that the concentration of glucose variation one in tissue fluid
As than concentration of glucose change delay 2-45 minutes in blood, average delay is about 6.7 minutes.But when the Portugal in blood
When grape sugar concentration starts to reduce, the concentration of glucose in tissue fluid is first reduced than the glucose in blood, shows tissue fluid
In reducing for concentration of glucose can make prediction for the low glucose that will occur.
With the development of scientific and technological level, all kinds of portable glucose detectors enter in the eye of people, especially certain
The continuous Glucose monitoring devices of a little implanteds, the even more favor by diabetic and various big hospital.But implanted is continuous
The service life of glucose detector is not often grown, and is easy the shadow by other impurities in vivo immunization reaction and blood
It rings so that sensitivity decrease.Therefore, how detection device is preferably constructed, extends the use of the sensing probe of glucose detector
Service life and the influence for reducing other factors become current greatest problem.
Summary of the invention
The disclosure is made in view of the foregoing, and its purpose is to provide a kind of service life for extending probe, drops
Low interference and the working electrode and preparation method thereof for improving the glucose monitoring probe for the reaction sensitivity of glucose.
For this purpose, the one side of the disclosure provides a kind of working electrode of glucose monitoring probe, have: basal layer；
Glucolase sensing layer is formed on the basal layer, can be chemically reacted with glucose；Semi-permeable membrane is formed in
On the glucolase sensing layer, the percent of pass of glucose molecule is controlled；And bio-compatible film, it is formed in the semi-permeable membrane
On, wherein between the basal layer and the glucolase sensing layer, it is provided with the nano particle of catalysis glucose response
Layer.
In the one side of the disclosure, the nanometer is provided between the basal layer and the glucolase sensing layer
Granulosa.In this case, the work needed for nano particle works normally working electrode the catalytic action of glucose response
Voltage reduces, and reduces the electroactive material under the high voltage of part and occurs what electrochemical reaction generation electric current generated working electrode
Interference；Probe is improved simultaneously to the reaction sensitivity of glucose, is also increased probe to the range of linearity of glucose responding, is prolonged
The service life of probe is grown.
It further include reference electrode in the working electrode of the probe of the glucose monitoring involved in the one side of the disclosure, institute
Stating reference electrode and the working electrode has potential difference.Reference electrode and working electrode form potential difference as a result, to accurately slap
Hold the electrode potential that working electrode is applied.
In the working electrode of the probe of the glucose monitoring involved in the one side of the disclosure, sensed in the glucolase
Between layer and the nano-particle layer, it is provided with nanofiber three-dimensional net structure.A large amount of glucose can be preferably fixed as a result,
Enzyme is more solidly fixed to it in three-dimensional net structure, improves the utilization rate of grape enzyme.
In the working electrode of the probe of the glucose monitoring involved in the one side of the disclosure, the semi-permeable membrane includes control
The diffusion-controlled layer of glucose molecule diffusion.In this case, when tissue fluid or glucose in blood molecule enter semi-permeable membrane,
The quantity of glucose molecule is by proportional diminution, and when reacting glucose with glucolase sensing layer, glucolase is passed
Feel layer and be in excessive state, concentration of glucose becomes the single factor of limitation working electrode currents, expands glucose monitoring spy
The range of linearity of the head when monitoring concentration of glucose.
In the working electrode of the probe of the glucose monitoring involved in the one side of the disclosure, the semi-permeable membrane includes preventing
The anti-interference layer of non-glucose substance.In this case, the other compositions in tissue fluid or blood is prevented to enter semi-permeable membrane,
It avoids the other electroactive materials that can equally generate electric current from influencing working electrode, causes glucose detection result inaccurate.
In the working electrode of the probe of the glucose monitoring involved in the one side of the disclosure, the nano-particle layer includes
Metal Pt nanoparticle.Thereby, it is possible to promote glucolase and glucose response.
In the working electrode of the probe of the glucose monitoring involved in the one side of the disclosure, the glucolase sensing layer
With a thickness of 0.1 μm to 100 μm.Thereby, it is possible to provide enough glucolases under the premise of abundant reaction and firm attaching.
In the working electrode of the probe of the glucose monitoring involved in the one side of the disclosure, the probe validity period is 3
It was to 24 days.Thereby, it is possible to facilitate the patient of different needs to select corresponding service life.
Another aspect of the present disclosure provides a kind of production method of the working electrode of glucose monitoring probe comprising:
Prepare flexible substrate；Basal layer is deposited in the flexible substrate, deposits nano-particle layer on the basal layer；It is received described
The glucolase sensing layer that can be reacted with glucose is coated on rice grain layer；It is formed on the glucolase sensing layer
Control the semi-permeable membrane of glucose molecule percent of pass；And bio-compatible film is formed on semi-permeable membrane.
In another aspect of the present disclosure, the nanometer for being catalyzed glucose response is deposited on ready basal layer
Granulosa.Working electrode operating voltage is reduced as a result, reduces other factors interference, improves probe for the anti-of glucose
Sensitivity is answered, probe is also increased to the range of linearity of glucose responding, extends the service life of probe.
It further include in nano particle in the production method of the working electrode of the probe of the glucose monitoring involved in the disclosure
Nanofiber three-dimensional network is set on layer.Thereby, it is possible to glucolase is adhered better on nano particle.
According to the disclosure, it is capable of providing a kind of service life for extending probe, is reduced and is interfered and improve for glucose
Reaction sensitivity glucose monitoring probe working electrode and preparation method thereof.
Detailed description of the invention
Fig. 1 is to show the schematic diagram of the probe use state of glucose monitoring involved in embodiment of the present disclosure.
Fig. 2 is to show the structural schematic diagram of the probe of glucose monitoring involved in embodiment of the present disclosure.
Fig. 3 is the structural schematic diagram for showing the probe of glucose monitoring involved in Fig. 2 and being in bending state.
Fig. 4 is to show the structural representation of the working electrode of the probe of glucose monitoring involved in embodiment of the present disclosure
Figure.
Fig. 5 is to show the glucose response of the probe and tissue of glucose monitoring involved in embodiment of the present disclosure
Schematic diagram.
Fig. 6 is to show the semi-permeable membrane of the working electrode of the probe of glucose monitoring involved in embodiment of the present disclosure
Structural schematic diagram.
Fig. 7 is to show the production method of the working electrode of the probe of glucose monitoring involved in embodiment of the present disclosure
Schematic diagram.
Fig. 8 is to show the production method of the working electrode of the probe of glucose monitoring involved in embodiment of the present disclosure
Flow chart.
Fig. 9 is to show the semi-permeable membrane system of the working electrode of the probe of glucose monitoring involved in embodiment of the present disclosure
Make the flow chart of method.
Specific embodiment
Hereinafter, explaining the preferred embodiment of the disclosure in detail with reference to attached drawing.In the following description, for identical
Component assign identical symbol, the repetitive description thereof will be omitted.Scheme in addition, attached drawing is only schematical, the mutual ruler of component
Very little shape of ratio or component etc. can be with actual difference.
In addition, the subhead etc. involved in describing below the disclosure is not intended to limitation content of this disclosure or model
It encloses, is merely possible to the suggesting effect read.Such subhead can neither be interpreted as the content for dividing article, also not
Content under subhead should be limited only in the range of subhead.
Fig. 1 is to show the schematic diagram of the probe use state of glucose monitoring involved in embodiment of the present disclosure.Fig. 2
It is to show the structure chart of the probe of glucose monitoring involved in embodiment of the present disclosure.Fig. 3 is shown involved in Fig. 2
Glucose monitoring probe is in the structure chart of folded state.
In the present embodiment, glucose monitoring probe 1 is referred to as implantable glucose monitoring probe, grape sometimes
The probe 1 or probe 1 of glucose monitor instrument.
In the present embodiment, portable glucose monitor G may include glucose monitoring probe 1 and supervise with glucose
The electronic system 2 that probing head 1 is connected.By the way that the glucose monitoring probe 1 of portable glucose monitor G is implanted to body
Table, the interstitial fluid contacts with body surface, so as to sense the glucose concentration signal of tissue fluid using glucose monitoring probe 1,
By the way that the glucose concentration signal is passed to electronic system 2, so as to obtain corresponding concentration of glucose.
Specifically, a part (especially transducing part) of glucose monitoring probe 1 can be implanted in such as human body
Body surface and with intracorporal interstitial fluid contacts.In addition, glucose monitoring probe 1 another part also be located at body surface Department of Electronics
2 connection of system.In portable glucose monitor G work, glucose monitoring probe 1 reacts generation sensing with intracorporal tissue fluid
Signal (such as current signal), and sensing signal is transmitted to the electronic system 2 of body surface, electronic system 2 to sensing signal into
Row processing, to obtain concentration of glucose.Although fig 1 illustrate that the allocation position of glucose monitoring probe 1, but present embodiment
It is without being limited thereto, such as glucose monitoring probe 1 also can be only fitted to abdomen, waist, leg etc..
In the present embodiment, although glucose monitoring probe 1 directly detect be tissue fluid glucose, tissue fluid
Concentration of glucose and blood concentration of glucose High relevancy, may determine that the grape of blood by the glucose of tissue fluid
Sugared concentration.
In the present embodiment, glucose monitoring probe 1 may include that substrate S and setting work electricity on the substrate's
Pole 10, reference electrode 20 and to electrode 30 (referring to fig. 2).In addition, glucose monitoring probe 1 can also include and working electrode 10
The contact 50 that is connect via the contact 40 of lead connection, with working electrode 20 via lead and with working electrode 30 via drawing
The contact 60 of line connection.In some instances, glucose monitoring probe 1 can be via contact 40, contact 50 and contact 60 and electricity
Subsystem 2 connects.
In some instances, substrate S can be flexible substrate.Flexible substrate can be substantially by polyethylene (PE), polypropylene
(PP), polyimides (PI), polystyrene (PS), polyethylene terephthalate (PET), polyethylene naphthalate
At least one of (PEN) it is made.In addition, flexible substrate can also be substantially by metal foil, ultra-thin glass in other examples
Glass, single-layer inorganic film, multilayer organic film or multilayer inorganic thin film etc. are made.
In some instances, substrate S is also possible to non-flexible substrate.It is weaker that non-flexible substrate can generally include electric conductivity
Ceramics, aluminium oxide or silica etc..In this case, the glucose monitoring probe 1 with non-flexible substrate simultaneously can
With with cusp or sharp edge, so as to which glucose is supervised in the case where not needing auxiliary implanted device (not shown)
Probing head 1 is implanted into skin (for example, skin shallow-layer etc.).
In the present embodiment, for convenience of explanation, glucose monitoring probe 1 can be divided into coupling part 1a and implanting portion
Divide 1b (referring to Fig. 3).Straight line A-A' in Fig. 3 illustrates in general skin institute when glucose monitoring probe 1 is implanted to tissue body surface
Approximate location.
In addition, in some instances, coupling part 1a and implant part 1b can include flexible substrate, but this embodiment party
Formula is without being limited thereto, for example, can only have implant part 1b includes flexible substrate, and coupling part 1a include non-flexible substrate for example
Rigid substrate.
In the present embodiment, the implant part 1b of glucose monitoring probe 1 can be set in puncture needle (not shown),
Implant part 1b and puncture needle are separable.Specifically, puncture can be needled into tissue, then by puncture needle extraction and and Portugal
The implant part 1b separation of grape glucose monitor probe 1, thus implant part 1b is left on skin shallow-layer, and is adjacent to electronic system 2
In skin surface, the coupling part 1a (referring to Fig. 3) of glucose monitoring probe 1 is connected with electronic system 2 and is located at skin table
Face.
In the present embodiment, puncture needle can have notch, and implant part 1b is placed in the notch of puncture needle.Its
In, puncture needle is made of stainless steel.In this case, the application risk of puncture needle is reduced, there is enough hardness, be convenient for
Puncture skin.Conducive to patient's use.In addition, in some instances, puncture needle can also be made of plastics, glass or metal.By
This, can control the cost of manufacture of puncture needle.
In the present embodiment, auxiliary implanted device (not shown) such as needle aiding device, which can be used, will puncture and be needled into skin
Skin.In which case it is possible to use the pre-configured paracentesis depth of needle aiding device, by realizing quick puncture using needle aiding device,
The purpose of painless puncture, reduces the feeling of pain of user.In addition, by assisting implanted device also to can be convenient one-handed performance.But
Present embodiment is without being limited thereto, for example, glucose monitoring probe 1 is in implantation skin when glucose monitoring probe 1 is rigid substrate
It can be not required to when skin by puncture needle.
In the present embodiment, the 1 subcutaneous depth of implantation of glucose monitoring probe is according to the different positions to be pierced into
Set determining, when fat deposit is thicker, implantation is deeper, such as human abdomen, implantation depth are about 10mm~15mm.Fat deposit compared with
It is implanted into shallower when thin, such as at arm, implantation depth is about 5mm~10mm.
Present embodiment is without being limited thereto, for example, implant part 1b and coupling part 1a can be all pierced into skin shallow-layer,
At this point, the width of coupling part 1a may be limited to about 2mm or smaller, in addition, the width of coupling part 1a also may be limited to
About 0.5mm or smaller.In this case, not only allow coupling part 1a to be more easily inserted into skin, can also pass through
The width of coupling part 1a is limited to limit the width of implant part 1b.Under normal conditions, the width of glucose monitoring probe 1
Narrower, the pain that user feels during and after implantation can be lighter.
In the present embodiment, as shown in Fig. 2, glucose monitoring probe 1 includes working electrode 10, specifically, such as Fig. 3
Shown, implant part 1b includes working electrode 10.
Fig. 4 is to show the structural representation of the working electrode of the probe of glucose monitoring involved in embodiment of the present disclosure
Figure.Fig. 5 is to show the signal of the probe and the glucose response of tissue of glucose monitoring involved in embodiment of the present disclosure
Figure.Fig. 6 is to show the knot of the semi-permeable membrane on the working electrode of the probe of glucose monitoring involved in embodiment of the present disclosure
Structure schematic diagram.
In the present embodiment, working electrode 10 has basal layer 110, nano-particle layer 120, glucolase sensing layer
130, semi-permeable membrane 140 and bio-compatible film 150 (referring to fig. 4).In some instances, basal layer 110, nano-particle layer 120, Portugal
Grape carbohydrase sensing layer 130, semi-permeable membrane 140 and bio-compatible film 150 can stack gradually.
In the present embodiment, basal layer 110 is electrically conductive.In some instances, basal layer 110 can by selected from gold,
At least one of vitreous carbon, graphite, silver, silver chlorate, palladium, titanium, iridium are made.In this case, basal layer 110 has good
Electric conductivity, and be able to suppress basal layer 110 occur electrochemical reaction, thus, it is possible to improve the stability of basal layer 110.
In the present embodiment, in some instances, basal layer 110 can be arranged by deposition or coating method in substrate
On.In some instances, the method for deposition may include physical vapour deposition (PVD), chemical vapor deposition etc..The method of plating can be with
Including plating, chemical plating, Vacuum Deposition etc..In addition, in some instances, basal layer 110 can also be by silk-screen printing, extrusion or electricity
The modes such as solution deposition are arranged in substrate S.
In the present embodiment, basal layer 110 can be set on flexible substrates.In this case, flexible substrate makes
Obtaining entire product becomes light, strong shock resistance, the foreign body sensation after reducing implantation.In other examples, basal layer 110 is also
It can be set in rigid substrate.
In the present embodiment, as shown in figure 4, nano-particle layer 120 can be set on basal layer 110.That is, in base
Between bottom 110 and glucolase sensing layer 130, nano-particle layer 120 can be set.In this case, metal platinum
Nano particle has been catalyzed reacting for glucose oxidase or dehydrogenase and glucose, and operating voltage needed for reducing reaction simultaneously mentions
High reaction rate.
In some instances, nano-particle layer 120 can be in cellular.In this case, in glucolase sensing layer
Glucolase can penetrate into nano-particle layer 120, nano-particle layer 120 being capable of production during glucose response as a result,
Object (such as hydrogen peroxide) comes into full contact with and is catalyzed reaction, so as to more efficiently promote glucose response.
In some instances, the nano particle in nano-particle layer 120 is made of metal platinum.In other examples
In, nano-particle layer 120 can also be made of at least one of titanium, gold, carbon.In this case, nano-particle layer 120 is same
Sample can play the role of catalytic oxidation-reduction reaction.
In the present embodiment, nano-particle layer 120 with a thickness of about 100nm~2 μm, preferably 500nm~2 μm.?
In one example, nano-particle layer 120 for example may be about 1 μm.
In the present embodiment, nano-particle layer 120 can be arranged on basal layer 110 by way of deposit.But
Present embodiment is without being limited thereto, can also be and basal layer 110 is arranged in by modes such as plating, chemical plating, evaporation, printing or extrusions
On.
In the present embodiment, glucolase sensing layer 130 can be glucose oxidase sensing layer, be also possible to grape
Glucocorticoid dehydrogenase sensing layer.In some instances, as shown in figure 4, glucolase sensing layer 130 can be coated in nano-particle layer
On 120.
Hereinafter, in conjunction with Fig. 5, with GOX(FAD) it is used as glucose oxidase and illustrates to send out in glucose sensing layer 130
Raw reaction.
In glucose sensing layer 130, work as GOX(FAD) when encountering the glucose in tissue, it may occur that following reaction:
Glucose+GOx (FAD) → gluconolactone+GOx (FADH2) ... reaction formula (I)
GOx(FADH2)+O2→GOx(FAD)+H2O2... reaction formula (II)
Oxygen (the O in above-mentioned reaction process as can be seen that in chemical reaction2) be consumed, O2Deficiency makes to react formula (II)
O is limited to formula (I) reaction speed is reacted2Amount, can slow down with reacting for tissue glucose, and glucose monitoring probe 1 is caused to lose
Effect.In addition, reacting in formula (II) in above-mentioned reaction process and having H2O2Product, H2O2Collection party make enzyme in sensing layer
Decline living also results in 1 failure of glucose monitoring probe.Therefore, by basal layer 110 and glucolase sensing layer 130 it
Between nano-particle layer 120 is set, under the action of nano-particle layer 120 is as catalyst, H can be made2O2It decomposes reaction,
Specific reaction is as follows:
H2O2→2H++O2+2e-... reaction formula (III)
By above-mentioned reaction formula (I) to formula (III) is reacted, can make persistently to carry out with reacting for tissue glucose.In addition,
The catalytic action that decomposing hydrogen dioxide solution reaction is played by using nano-particle layer, thus, it is possible to accelerate the progress of reaction (III) simultaneously
The voltage of required application in reaction process is reduced, to be conducive to improve the sensitivity of glucose monitoring probe 1, extend grape
Glucose monitor probe 1 uses the time, and obtains low-work voltage.In other words, it by nano-particle layer 120, can constantly obtain
The highly sensitive sensing signal of tissue glucose is obtained, extend glucose monitoring probe 1 uses the time, while low-work voltage has
Conducive to promotion interference free performance.
In some instances, conductive polymer nanometer fibre three-dimensional net can also be arranged in glucose oxidase or dehydrogenase
In network, that is, nanofiber three-dimensional network is arranged between nano-particle layer 120 and glucolase sensing layer 130.Increase as a result,
Add the adhesion of glucose oxidase or dehydrogenase on nano-particle layer 120, improves glucose oxidase or dehydrogenase
Fixed amount.
In some instances, glucose oxidase or dehydrogenase can also be arranged on the carbon nanotubes, wherein carbon nanotube
It is arranged on nano-particle layer 120.The attachment of glucose oxidase or dehydrogenase on nano-particle layer 120 is increased as a result,
Property and fixed amount.
In other examples, glucose oxidase or dehydrogenase can also be arranged in graphene, poriferous titanium dioxide or
On conducting organic salt.The adhesion of glucose oxidase or dehydrogenase or dehydrogenase on nano-particle layer 120 is increased as a result,
And fixed amount.
In the present embodiment, by 1 implantation human skin of glucose monitoring probe, the glucose in blood can be carried out
It continuously samples, and is converted to corresponding current signal, be transmitted in external electronic system 2.In addition, sampling refers to grape
Glucose oxidase or dehydrogenase on carbohydrase sensing layer 120 are chemically reacted with glucose.
In the present embodiment, the thickness of glucolase sensing layer 130 may be about 0.1 μm~100 μm, preferably about 2 μ
M~10 μm, in one example, the thickness of glucolase sensing layer 130 can be 10 μm.In this case, by glucose
The thickness control of oxidizing ferment or dehydrogenase to a certain extent, excessively causes so as to avoid glucose oxidase or dehydrogenase
Adhesive force decline, cause material to fall off in vivo, also avoid glucose oxidase or dehydrogenase it is very few caused by react
It is insufficient, the problems such as normal concentration of glucose information out can not be fed back.
In the present embodiment, as shown in Figure 4 and Figure 6, semi-permeable membrane 140 can be distributed on glucolase sensing layer 130,
That is, semi-permeable membrane 140 can be set on glucolase sensing layer 130.
In addition, in the present embodiment, as shown in fig. 6, semi-permeable membrane 140 can also include diffusion-controlled layer 141 and stacking
Anti-interference layer 142 on diffusion-controlled layer 141.In some instances, diffusion-controlled layer 141 can be set in anti-interference layer
Outside 142.In semi-permeable membrane 140, diffusion-controlled layer 141 can control the diffusion of glucose molecule, and anti-interference layer 142 can prevent
The diffusion of non-glucose substance.Thus, it is possible to first reduce the tissue fluid or blood constituent for passing through semi-permeable membrane 140, then by anti-dry
It disturbs layer 142 chaff interferent is blocked in outside semi-permeable membrane 140.Common chaff interferent may include generally existing uric acid, anti-bad in vivo
Hematic acid, acetaminophen etc..
In other examples, it is not limited to the example of Fig. 6, anti-interference layer 142 can also be arranged in diffusion-controlled layer 141
Outside.Interference of the impurity to working electrode 10 can be equally reduced as a result, it is inaccurate to lead to testing result, and extends glucose prison
1 service life of probing head.
In the present embodiment, semi-permeable membrane 140 can control the percent of pass of glucose molecule, i.e. semi-permeable membrane 140 can limit
The quantity of the glucose molecule of glucolase sensing layer 130 is reached in tissue fluid or blood processed.Specifically, semi-permeable membrane 140
Diffusion-controlled layer 141 will can effectively diffuse to the contracting of the quantity of the glucose of glucolase sensing layer 130 by a certain percentage
It is small.
In the present embodiment, diffusion-controlled layer 141 can reduce into object multiplying power be 10~100 times, preferably 30
~80 times, for example, 50 times.In this case, the quantity that glucose diffuses to glucolase sensing layer can be reduced, is guaranteed
Glucose oxidase or dehydrogenase and other substances for participating in reaction are enough, and concentration of glucose becomes mainly (substantially only
One) electrode current size factor is limited, to make size of current can correctly reflect out the concentration of glucose, and largely
On can increase glucose monitoring probe 1 the range of linearity.
In the present embodiment, bio-compatible film 150 can be set on semi-permeable membrane 140 (referring to fig. 4).
In some instances, bio-compatible film 150 can be made of vegetable material.Vegetable material can be sodium alginate,
Tragacanth, pectin, Arabic gum, xanthan gum, guar gum, agar etc. or natural material derivative include: starch derivatives, fibre
Tie up plain derivative etc..
In other examples, bio-compatible film 150 can also be made of synthetic material.Synthetic material can be with
It is polyolefins: povidone, polyvinyl alcohol, Medical PSA, ethylene-vinyl acetate copolymer etc.；It is also possible to poly- third
Olefin(e) acid class: acrylic resin, carboxy vinyl-sucrose, carboxy vinyl-pentaerythrite copolymer, polyacrylate pressure-sensitive etc.；?
It can be polyoxyethylene: the polyesters such as polyoxyethylene fatty acid ester, Pluronic F68: polylactic acid, poly- second
Lactide-lactide, poly- di-n-nonyl sebacate, paracyanogen base alkyl amino ester, polyether-polyurethane etc..Thereby, it is possible to reduce human body pair
The immune response of glucose monitoring probe 1 extends the service life of glucose monitoring probe 1.
In addition, in some instances, semi-permeable membrane 140 can also have biocompatibility.Thereby, it is possible to avoid using biology
Compatible film 150, reduces the production cost.
In other examples, the infiltration for being formed by film to analyte of concern can be adjusted by modifying agent
Property.For example, hydrophilic modifier includes: polyethylene glycol, hydroxyl or polyhydroxy modifying agent.Thus, it is possible to increase polymer
It is formed by the biocompatibility of film, bio-compatible film is replaced with this.
In the present embodiment, the entire glucose monitoring probe 1 of 150 layers of bio-compatible film covering.Thereby, it is possible to reduce pair
The required precision of technique.
In some instances, bio-compatible film 150 only covers the implant part 1b that glucose monitoring probe 1 implants.
Thereby, it is possible to reduce the use of raw material.
In the present embodiment, 1 validity period of glucose monitoring probe can be 1 day to 24 days, preferably 7 days to 14 days.
In addition, as described above, by 140 restricted part glucose molecule of semi-permeable membrane and electroactive interfering substance into and can be effective
Ground expands the range of linearity of probe 1 and better glucose oxidase or dehydrogenase, energy is arranged in glucolase sensing layer 130
The service life of glucose monitoring probe 1 is enough set to keep stablizing.
In addition, glucose monitoring probe 1 also can be used in common detection, such as word detection or short time prison
It surveys.Such as the time of monitoring can be 1 hour to 24 hours.
In addition, the addition of bio-compatible film 150 can pop one's head in glucose monitoring, 1 validity period is maintained at 1 day to 24 days, by
This can be convenient for users to the glucose monitoring probe 1 according to different demands (such as price etc.) selection with different service life
Glucose monitoring devices.
In the present embodiment, as described above, glucose monitoring probe 1 can also be including reference electrode 20 and to electrode 30
(referring to fig. 2).Specifically, as shown in figure 3, the implant part 1b of glucose monitoring probe 1 may include 20 He of reference electrode
To electrode 30.
In the present embodiment, the glucose monitoring probe 1 after being pierced into skin can pass through the grape in working electrode 10
Glucose in carbohydrate oxidase or dehydrogenase and tissue fluid or blood carries out redox reaction, and is formed into a loop with to electrode 30
To generate current signal.
In the present embodiment, reference electrode 20 can form known and fixed potential difference with tissue fluid or blood.?
In this case, working electrode 10 and tissue fluid can be measured by the potential difference that reference electrode 20 and working electrode 10 are formed
Or the potential difference between blood, to accurately grasp voltage caused by working electrode 10.Electronic system 2 can be according to pre- as a result,
The voltage value first set automatically adjusts and maintains the stabilization of voltage at working electrode, to guarantee that the current signal of measurement can be accurate
Reflect glucose concentration value.
In addition, in the present embodiment, the working electrode 10 of implant part 1b, reference electrode 20 and electrode 30 is used
The method of dispersed placement, but embodiment of the present disclosure is without being limited thereto, can also include (arranged side by side) side by side arrange.
In addition, in the present embodiment, glucose monitoring probe 1 is not limited to plane probe, can also be line style probe,
Probe with stacked electrodes or layered electrode, and the probe of coplanar electrodes that electrode is disposed on the same plane.
It in some instances, can be with when the potential difference variation fluctuation between working electrode and tissue fluid or blood is little
Without using reference electrode.The manufacturing cost of glucose monitoring probe 1 is saved as a result,.
In the present embodiment, electrode 30 can be made of platinum, silver, silver chlorate, palladium, titanium or iridium.Thus, it is possible to having
The electrochemical reaction at working electrode 10 is not influenced in the case where having satisfactory electrical conductivity.But present embodiment is without being limited thereto, another
It, can also be by selected from least one of gold, vitreous carbon, graphite, silver, silver chlorate, palladium, titanium or iridium to electrode 30 in some examples
It is made.Thus, it is possible to reduce the influence to working electrode 10 with satisfactory electrical conductivity.
In addition, in some instances, same material can be used to electrode 30, reference electrode 20 in working electrode 10.
In addition, in the present embodiment, glucose monitoring probe 1 may include two or three or more electrodes.Example
Such as, glucose monitoring probe 1 can be only including working electrode 10 and to 30 two electrodes of electrode, in addition, glucose monitoring probe 1
In addition to working electrode 10, reference electrode 20 and to can also include additional reference electrode other than electrode 30.In this case,
Working electrode potential difference can more accurately be obtained and grasp working electrode voltage, to obtain more accurate electric current.
In the present embodiment, as described above, the coupling part 1a of glucose monitoring probe 1 includes the (touching of multiple contacts
Head).The number of contact is equal with the number of poles of implant part 1b of glucose monitoring probe 1.Contact is with implant part 1b's
There is lead (conducting wire) connection between electrode.
In the present embodiment, as shown in figure 3, there are three the number of poles of the implant part 1b of glucose monitoring probe 1.
Correspondingly, coupling part 1a includes three contacts (contact), is contact 40, contact 50 and contact 60 respectively.But present embodiment
It is without being limited thereto, for example, the number of poles of implant part 1b can be two or more than four electrodes, correspondingly, coupling part
1a may include two or more than four contacts (contact).
In the present embodiment, contact 40, contact 50 and contact 60 can be in disk form.In other examples, touching
Point 40, contact 50 and contact 60 can also be rectangle, ellipse or other irregular shapes.
In the present embodiment, the current signal that the implant part 1b of glucose monitoring probe 1 is generated can pass through substrate
Layer 110 and transfer wire are transmitted to the contact of coupling part 1a.That is, glucose monitoring probe 1 implant part 1b with connect
Part 1a connection, and coupling part 1a is connected via multiple contacts with electronic system 2, therefore, the electricity obtained by working electrode 10
Stream signal is delivered in electronic system 2 by the contact of coupling part 1a to be analyzed.Electronic system 2 can to current signal into
Row analysis handles to obtain glucose concentration signal.In addition, electronic system 2 can mode such as bluetooth, wifi by wireless communication
Etc. launching.External reading equipment (not shown) can receive the glucose concentration signal of electronic system sending, and show
Show glucose concentration value.In addition, the probe of the glucose monitoring as involved in present embodiment 1 may be implemented to continue to monitor, because
This can be realized the purpose for continuing to monitor human glucose concentration value for a long time (such as 1 day to 24 days).In addition, in some examples
In, reading equipment can be reader or cell phone application.
In addition, in the present embodiment, glucose monitoring probe 1 and electronic system 2 can be not required to during use in vivo
It calibrates.In addition, glucose monitoring probe 1 and electronic system 2 can be completed to calibrate in advance when leaving the factory.Use is eliminated as a result,
Family needs the trouble periodically calibrated by referring to blood to monitoring system, and also reduces monitoring modular reading during use
The potential source of error.
In the present embodiment, electronic system 2 can be made of flexible PCB and flexible battery.Thereby, it is possible to be close to skin
Skin reduces the influence to user's daily life.In some instances, the shape of electronic system 2 can be in rounded shape.In addition,
In some examples, electronic system 2 can also have waterproof case and waterproof band-aid, and thereby, it is possible to not shadows when users use
Ring the daily routines such as swimming or bathing.
In the present embodiment, glucose monitoring is popped one's head in the concentration of glucose in 1 available tissue fluid or blood.But this
Embodiment is without being limited thereto, for example, by changing the sensing layer on glucose monitoring probe 1, it is also available in addition to glucose
Other body fluid components data, body fluid components here for example can be acetylcholine, amylase, bilirubin, cholesterol, villus
Film promoting sexual gland hormone, creatine kinase, creatine, kreatinin, DNA, fructosamine, glucose, glutamine, growth hormone, hormone, ketone
Body, lactate, oxygen, peroxide, prostate-specific antigen, factor, RNA, thyrotropic hormone and troponin etc..
In other examples, the concentration of drug in body fluid can also be monitored, for example, antibiotic (for example, gentamicin,
Vancomycin etc.), foxalin, digoxin, theophylline and warfarin (warfarin) etc..
In the present embodiment, firstly, one layer is arranged on the basal layer 110 of working electrode 10 for being catalyzed grape glycosyloxy
Change and forms glucolase sensing layer 130 after the nano-particle layer 120 of enzyme or dehydrogenase and glucose response on this basis, then
140 coating of semi-permeable membrane is formed on glucolase sensing layer 130, and bio-compatible film 150 is finally formed on 140 coating of semi-permeable membrane
Layer.Portugal is also improved while reducing other factors interference in the service life for extending glucose monitoring probe 1 as a result,
Reaction speed of the grape glucose monitor probe 1 for glucose.
Describe the production method of the working electrode of glucose monitoring probe 1 in detail below in conjunction with attached drawing.
Fig. 7 is to show the production method of the working electrode of the probe of glucose monitoring involved in embodiment of the present disclosure
Schematic diagram.Fig. 8 is to show the production side of the working electrode of the probe of glucose monitoring involved in embodiment of the present disclosure 1
The flow chart of method.Fig. 9 be show glucose monitoring involved in embodiment of the present disclosure probe 1 working electrode it is semi-transparent
The flow chart of film production method.
In the present embodiment, the production method of the working electrode of glucose monitoring probe 1 may include (referring to Fig. 7 and
Fig. 8): firstly, depositing conductive basal layer 110 (step S110) in ready flexible substrate, then being deposited on basal layer 110
For being catalyzed the nano-particle layer 120 (step S120) of glucose oxidase or dehydrogenase and glucose response, then, in nanometer
The glucolase sensing layer 130 (step S130) that can be reacted with glucose is coated on stratum granulosum 120, then, in grape
Semi-transparent membrane coat 140 (step S140) is formed on carbohydrase sensing layer 130, finally forms bio-compatible on semi-transparent membrane coat 140
Film layer 150 (step S150).As a result, in the service life for extending glucose monitoring probe 1, extraneous factor interference is reduced
Meanwhile glucose monitoring probe 1 is also improved for the reaction speed of glucose.
In the present embodiment, the glucolase sensing layer 130 in step S130 can be glucose oxidase sensing layer,
It is also possible to glucose dehydrogenase sensing layer.
In production method involved in present embodiment, as shown in figure 9, further including first in glucose in step S140
Anti-interference layer 142 (step S141) is formed on enzyme sensing layer 130, then 141 (step of diffusion-controlled layer is formed on anti-interference layer
S142).Thus, it is possible to which first passing through anti-interference layer 142 reduces the tissue fluid or blood constituent for passing through semi-permeable membrane 140, then pass through expansion
It dissipates control layer 141 chaff interferent is blocked in outside semi-permeable membrane 140.
In some instances, in step S140, the sequence of step S141 and step S142 be can be interchanged.That is, can be with
Diffusion-controlled layer (step S142) is formed first on glucose oxidase or dehydrogenation enzyme layer, is then formed on anti-interference layer anti-
It interferes layer (step S141).Interference of the impurity to working electrode 10 can be equally reduced as a result, prevent testing result inaccurate,
And extend glucose monitoring 1 service life of probe.
Furthermore it is also possible to by one of modes such as plating, evaporation, printing or extrusion or a variety of make basal layer
110 or nano-particle layer 120.
In addition, further including that Nanowire is arranged on nano-particle layer 120 in the production method involved in present embodiment
Tie up three-dimensional net structure.Thereby, it is possible to make glucose oxidase or dehydrogenase preferably be attached to nanofiber three-dimensional network
On the nano particle of structure.
In other examples, one layer of nano fibrous membrane can also be covered on nano-particle layer 120.It reduces as a result,
Requirement to technique, and glucose oxidase or dehydrogenase can also be made preferably to be attached on nano particle.
Although being illustrated in conjunction with the accompanying drawings and embodiments to the disclosure above, it will be appreciated that above description
The disclosure is not limited in any form.Those skilled in the art can without departing from the connotation and range of the disclosure
To be deformed and be changed to the disclosure as needed, these deformations and variation are each fallen in the scope of the present disclosure.
Claims (10)
1. a kind of working electrode of glucose monitoring probe, which is characterized in that
Have:
Basal layer；
Glucolase sensing layer is formed on the basal layer, can be chemically reacted with glucose；
Semi-permeable membrane is formed on the glucolase sensing layer, controls the percent of pass of glucose molecule；And
Bio-compatible film is formed on the semi-permeable membrane,
Wherein, between the basal layer and the glucolase sensing layer, it is provided with the nano particle of catalysis glucose response
Layer.
2. working electrode according to claim 1, which is characterized in that
It further include reference electrode, the reference electrode and the working electrode are formed with potential difference.
3. working electrode according to claim 1, which is characterized in that
Between the glucolase sensing layer and the nano-particle layer, it is provided with nanofiber three-dimensional net structure.
4. working electrode according to claim 1, which is characterized in that
The semi-permeable membrane includes the diffusion-controlled layer for controlling glucose molecule diffusion.
5. working electrode according to claim 1, which is characterized in that
The semi-permeable membrane includes the anti-interference layer for preventing non-glucose substance.
6. working electrode according to claim 1, which is characterized in that
The nano-particle layer includes metal Pt nanoparticle.
7. working electrode according to claim 1, which is characterized in that
The glucolase sensing layer with a thickness of 0.1 μm to 100 μm.
8. working electrode according to claim 1, which is characterized in that
The validity period of the probe is 1 day to 24 days.
9. a kind of production method of the working electrode of glucose monitoring probe, which is characterized in that
Include:
Prepare flexible substrate；
Basal layer is deposited in the flexible substrate；
Nano-particle layer is deposited on the basal layer；
The glucolase sensing layer that can be reacted with glucose is coated on the nano-particle layer；
The semi-permeable membrane of control glucose molecule percent of pass is formed on the glucolase sensing layer；And
Bio-compatible film is formed on semi-permeable membrane.
10. the production method of working electrode according to claim 9, which is characterized in that
It further include the setting nanofiber three-dimensional net structure between the glucolase sensing layer and nano-particle layer.
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| CN202010247630.4A CN111307906B (en) | 2017-12-29 | 2018-12-29 | Analyte monitoring probe |
| CN202011507713.9A CN112710712B (en) | 2017-12-29 | 2018-12-29 | Portable glucose monitor |
| CN202011511779.5A CN112710713B (en) | 2017-12-29 | 2018-12-29 | Implanted glucose monitoring probe |
| CN202110212726.1A CN112964770A (en) | 2017-12-29 | 2018-12-29 | Glucose monitoring probe and glucose monitor |
| CN202110212736.5A CN112964771B (en) | 2017-12-29 | 2018-12-29 | Glucose monitoring probe for continuous monitoring |
| CN201811640852.1A CN110057889B (en) | 2018-12-29 | 2018-12-29 | Working electrode of glucose monitoring probe and manufacturing method thereof |
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| CN202110212726.1A Division CN112964770A (en) | 2017-12-29 | 2018-12-29 | Glucose monitoring probe and glucose monitor |
| CN202110212736.5A Division CN112964771B (en) | 2017-12-29 | 2018-12-29 | Glucose monitoring probe for continuous monitoring |
| CN202011511779.5A Division CN112710713B (en) | 2017-12-29 | 2018-12-29 | Implanted glucose monitoring probe |
| CN202011507713.9A Division CN112710712B (en) | 2017-12-29 | 2018-12-29 | Portable glucose monitor |
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| CN110057889A true CN110057889A (en) | 2019-07-26 |
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| CN202010247630.4A Active CN111307906B (en) | 2017-12-29 | 2018-12-29 | Analyte monitoring probe |
| CN202011507713.9A Active CN112710712B (en) | 2017-12-29 | 2018-12-29 | Portable glucose monitor |
| CN202011511779.5A Active CN112710713B (en) | 2017-12-29 | 2018-12-29 | Implanted glucose monitoring probe |
| CN202110212726.1A Pending CN112964770A (en) | 2017-12-29 | 2018-12-29 | Glucose monitoring probe and glucose monitor |
| CN201811640852.1A Active CN110057889B (en) | 2017-12-29 | 2018-12-29 | Working electrode of glucose monitoring probe and manufacturing method thereof |
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| CN202011507713.9A Active CN112710712B (en) | 2017-12-29 | 2018-12-29 | Portable glucose monitor |
| CN202011511779.5A Active CN112710713B (en) | 2017-12-29 | 2018-12-29 | Implanted glucose monitoring probe |
| CN202110212726.1A Pending CN112964770A (en) | 2017-12-29 | 2018-12-29 | Glucose monitoring probe and glucose monitor |
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| CN113083647A (en) * | 2019-12-23 | 2021-07-09 | 浙江荷清柔性电子技术有限公司 | Polymer diffusion-limiting membrane layer, preparation method thereof and glucose sensor |
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| CN113075142B (en) * | 2021-03-31 | 2023-10-03 | 复星诊断科技(长沙)有限公司 | Creatinine test strip and application thereof |
| CN113325058A (en) * | 2021-04-29 | 2021-08-31 | 苏州中星医疗技术有限公司 | Implantable glucose biosensor and preparation method thereof |
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Also Published As
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| CN111307906A (en) | 2020-06-19 |
| CN112710712B (en) | 2022-05-17 |
| CN112964770A (en) | 2021-06-15 |
| CN112710713A (en) | 2021-04-27 |
| CN110057889B (en) | 2021-03-16 |
| CN111307906B (en) | 2022-01-11 |
| CN112964771A (en) | 2021-06-15 |
| CN112710713B (en) | 2022-04-29 |
| CN112710712A (en) | 2021-04-27 |
| CN112964771B (en) | 2022-04-29 |
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Address after: 518052 District D, Floor 3, Tingwei Industrial Park, No. 6, Liufang Road, Xin'an Street, Bao'an District, Shenzhen, Guangdong Patentee after: SHENZHEN GUIJI SENSING TECHNOLOGY CO.,LTD. Patentee after: Shenzhen Silicon Bionics Technology Co.,Ltd. Address before: 518052 District D, Floor 3, Tingwei Industrial Park, No. 6, Liufang Road, Xin'an Street, Bao'an District, Shenzhen, Guangdong Patentee before: SHENZHEN GUIJI SENSING TECHNOLOGY CO.,LTD. Patentee before: SHENZHEN SIBIONICS TECHNOLOGY Co.,Ltd. |
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