CN102920465A - Glucose sensor - Google Patents
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- CN102920465A CN102920465A CN201210416267XA CN201210416267A CN102920465A CN 102920465 A CN102920465 A CN 102920465A CN 201210416267X A CN201210416267X A CN 201210416267XA CN 201210416267 A CN201210416267 A CN 201210416267A CN 102920465 A CN102920465 A CN 102920465A
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Abstract
The invention discloses a glucose sensor, which comprises a counter electrode and at least one working electrode, wherein the counter electrode and the working electrode are fixedly arranged on a base; and a degradable layer is coated on the outermost layer of the at least one working electrode. By coating the degradable layer on the surface of the working electrode of the sensor, a relay mechanism of sequential enzyme release can be formed, the service life of the sensor can be obviously prolonged compared with the conventional service life of 3-5 days, and the correction frequency of the sensor is reduced compared with that of the conventional sensor. The sensor has the advantages of small size, relatively simple manufacturing process and low manufacturing cost. Since the service life of the sensor is prolonged, a patient needs not to frequently replace the sensor, and the economic burden of the patient is also obviously reduced. The implanted or intrusive real-time detection glucose sensor with long service life and good biocompatibility has broad application prospect in implanted or intrusive medical detection equipment.
Description
Technical field
The present invention relates to a kind of glucose sensor, belong to the medical treatment detection device field.
Background technology
Diabetes serious threat human health, the diabetes patient needs to regulate diet by repeatedly measuring blood glucose concentration every day, to reach the purpose of control blood glucose.Traditional blood sugar monitoring methods is the finger tip blood collection method, the method testing result is accurate, but patient has sense of discomfort and fear more, and the number of times that detect every day is limited, can not be complete real-time reflection patient's change of blood sugar, therefore can not provide enough valuable treatment foundations, and the continuous detecting data message just can provide basic improvement for diagnosis and the treatment of diabetes.
Endermic implantating real time blood sugar monitoring system is implanted sensor probe subcutaneous, can the continuous monitoring tissue fluid in the concentration of glucose, by calibration, then can obtain the concentration value of glucose in blood.The general abdominal part of implanting of subcutaneous implantation probe, wound to health is less, a probe generally can use 3-5 days, during implanting, the patient only needs come calibrating sensors 2-3 time from the finger tip blood sampling every day, just can obtain in real time 24 hours continuous blood sugar value, can reflect in real time patient's change of blood sugar, for control and the treatment of diabetes provides enough foundations.
But use when surpassing this time limit generally at 3-5 days sensor probe service life of existing Endermic implantating real time blood sugar detecting sensor, and the measurement result of sensor can be inaccurate.The poor continuously use rear stability reduction that causes popping one's head in of sensor surface biocompatibility, measurement result is inaccurate to be the restriction key factor in probe life-span.
The Chinese patent CN1644157A of Sheng Meidinuo medical science and technology company limited application discloses a kind of biosensor of subcutaneous implantation, the positive and negative two pieces of electrodes of pin type are vertically fixed on the pedestal, during use positive and negative electrode is inserted subcutaneous tissue, the carcass below the pedestal can be fixed in skin surface with sensor.Oxygen in the tissue fluid and glucose enter enzyme reaction layer with the macromolecule infiltration rete of mode by electrode surface of diffusion, the current intensity that reaction produces is directly proportional with tested concentration of glucose, the dynamic glucose sensor controlled circuit that cooperates patent CN201001732Y can show in real time with detecting data.Sheng Meidinuo company is converted into product DGMS with this patent, the implantable subcutaneous 3-5 of sensor days, refreshed blood glucose concentration value one time in per 3 minutes, and recorded 480 blood glucose level datas every day, can directly show 4 hours on the screen and can look back nearest 72 hours dynamic glucose change curve.
Chinese patent literature CN101530327A is poor for glucose sensor bio-compatibility in the prior art, the deficiency of its blood glucose value at that time can not be provided to user in real time, good needle amperometric determination type glucose sensor for subcutaneous tissue real-time monitoring of a kind of bio-compatibility and preparation method thereof is provided, the working electrode of this sensor has conductive layer, the macromolecular material theca interna, enzyme membrane layer and macromolecular material control diffusion layer cover successively from the inside to the outside and form.The hydrophilic hydration layer of macromolecular material control diffusion layer surface parcel one deck space lattice can stop the loss of enzyme, slows down the diffusion than macromole such as protein, reduces electrode interference.But continuous operation was more than 72 hours after this electrode implantation was subcutaneous.
Can be found out by above analysis, the service life of existing Endermic implantating real time blood sugar detecting sensor is too short, and the patient needs often to change monitoring probe, and it is not very convenient using, and the price of existing probe is about dozens of yuan on the market, and frequent can allow patient's financial burden sharply increase.
Summary of the invention
Technical problem to be solved by this invention provides a kind of glucose sensor with new construction.
Inventive concept of the present invention is: the electrode surface of existing insertion type glucose sensor can wrap up one deck biocompatible materials, such as cellulose acetate, polyurethane, polyvinyl alcohol and Nafion etc., these material properties are more stable, can very fast metabolism not fall, collagen fiber can surround implant and form tunicle, be the tissue capsule of foreign object in causing, normal tissue and implant are kept apart, the formation of fibrous tissue has stoped the diffusion of glucose to sensor internal, fibrous layer is thicker, the diffusion of glucose is more difficult, reduces along with the increase of implantation or intervention time so subcutaneous rear sensitivity meeting is implanted or got involved to sensor.
For this reason, on the basis of existing insertion type Real-Time Monitoring glucose sensing electrodes, the present invention applies one deck degradable biocompatibility material in the outmost surface of working electrode, on the one hand as protective material, can prevent the loss of enzyme; On the other hand, in the degradation process of material, enzyme is slowly discharged, the enzyme of rear release can remedy the inefficacy of the enzyme that discharges first, degradation rate by the control material, can make the inefficacy of enzyme and the release of enzyme reach balance, thereby make the catalytic efficiency of glucoseoxidase keep constant, thereby form the relay mechanism that enzyme successively discharges.Moreover, after degradable material implants, catabolite is nontoxic, can participate in the metabolism in the body and excrete, the good biocompatibility of material, so the formation of collagen fiber relaxes with respect to non-degradation biological compatibility material, thinner fibrous layer to the barrier effect of glucose a little less than, the sensitivity after sensor is implanted can reduce relatively.In addition, degradation material can be made into the structure of porous, and the structure of porous can increase the formation of neovascularity, the new blood vessel that forms can improve the seriality of tissue, reduce blood to the distance of sensor, blood also just can be easier to be diffused into sensor surface by sensor measurement, and then sensor just can be measured the change of blood sugar of blood preferably.And the good fibrous tissue that has a large amount of neovascularity to distribute distributes around sensor and also can make sensor long-term stable operation in the situation of not proofreading and correct.
Kind and the thickness of the degradation material that the outmost surface of working electrode applies can be selected according to required degradation time.For commaterial, thickness is thicker or concentration is higher, and the required time of degrading all can correspondingly increase.Thickness or the concentration of degradation material of the surface-coated by the control working electrode just can be controlled the degradation time of material, thereby the rate of release of control enzyme reaches the purpose of prolongation working sensor time.
Specifically, the present invention solves the technical scheme that its technical problem takes: a kind of glucose sensor, comprise that of being fixedly installed on the pedestal to electrode and at least one working electrode, wherein, has at least the outermost layer of a described working electrode to be coated with biodegradable layer.
Further, working electrode of the present invention is one, and described biodegradable layer covers the outermost regional area of working electrode.
Further, working electrode of the present invention is more than two, and to have a working electrode at least be to be coated with described biodegradable layer at its outermost regional area.
Further, the thickness of biodegradable layer of the present invention is and increases progressively state.
Further, the thickness of biodegradable layer of the present invention is stepped.
Further, working electrode of the present invention is more than two, and has at least a working electrode not apply biodegradable layer.
Further, the thickness of biodegradable layer of the present invention is and increases progressively state.
Further, the thickness of biodegradable layer of the present invention is stepped.
Further, working electrode of the present invention comprises metal conducting layer, enzyme catalysis layer and macromolecular material control diffusion layer, and described metal conducting layer, enzyme catalysis layer, macromolecular material control diffusion layer distribute by order from inside to outside.
Further, biodegradable layer of the present invention is loose structure.
Compared with prior art, the invention has the beneficial effects as follows: apply one deck biodegradable layer by the working electrode surface at sensor, can form the relay mechanism that enzyme successively discharges, and the life-span of sensor was significantly increased than existing 3-5 days, and the number of corrections of sensor also reduces to some extent than existing.The volume of sensor of the present invention is little, processing technology is relatively simple, and cost of manufacture is low.And because improve the service life of sensor, and the patient does not need frequent, patient's financial burden also has significant reduction.The implanted of this long service life, good biocompatibility or insertion type detect in real time glucose sensor and have broad application prospects in implanted or insertion type medical treatment detection device.
Description of drawings
Top view when Fig. 1 is glucose sensor employing three-electrode system of the present invention;
Side view when Fig. 2 is glucose sensor employing three-electrode system of the present invention;
Fig. 3 is the structural representation that the surface portion of the working electrode of glucose sensor of the present invention applies degradation material;
Fig. 4 is that working electrode among Fig. 3 is along the cutaway view of A-A face;
Fig. 5 is the structural representation that the surface portion of the single aciculiform working electrode of glucose sensor of the present invention applies degradation material;
Fig. 6 is the structural representation that the surface of the aciculiform working electrode of glucose sensor of the present invention all evenly applies degradation material;
Fig. 7 is that the thickness of biodegradable coating on surface of the aciculiform working electrode of glucose sensor of the present invention is the structural representation that increases progressively gradually state;
Fig. 8 is the stepped structural representation of thickness of biodegradable coating on surface of the aciculiform working electrode of glucose sensor of the present invention;
Fig. 9 is the sketch map that the working electrode of glucose sensor of the present invention adopts single plane electrode;
Figure 10 is that working electrode among Fig. 9 is along the cutaway view of A-A face;
Figure 11 is the sketch map that the working electrode of glucose sensor of the present invention adopts a plurality of plane electrodes.
The specific embodiment
Referring to Fig. 1 and 2, glucose sensor of the present invention comprises one to electrode 2 and at least one working electrode 3, and electrode 2 and working electrode 3 are installed on the pedestal 1.In the present invention, the composition of electrode can for two-electrode system (namely by one electrode 2 and at least one working electrode 3 being consisted of), also can be three-electrode system (namely by electrode 2, at least one working electrode 3 and a reference electrode 4 being consisted of) as depicted in figs. 1 and 2.
In the present invention, the shape of electrode can be needle electrode, also can be plane electrode.Wherein, plane electrode can have any shape, as circular, oval, square etc.Below take needle electrode and circular flat electrode as example, the present invention will be further described.
Take the aciculiform working electrode as example, in embodiment shown in Figure 3, the working electrode 3 of glucose sensor comprises metal conducting layer 5, enzyme catalysis layer 6, macromolecular material control diffusion layer 7, and metal conducting layer 5, enzyme catalysis layer 6, macromolecular material control diffusion layer 7 distribute by order from inside to outside.As the glucose sensor working electrode 3 of implantation or insertion type, the base metal of metal conducting layer 5 is generally selected rustless steel, so that working electrode has enough rigidity, is easy to sting transdermal, implants or get involved subcutaneous.The surface of metal conducting layer 5 is by sputter or electroplate one deck noble metal nano particles layer, such as gold or Pt nanoparticle; Then, form enzyme catalysis layer 6 by enzyme immobilization methods such as crosslinked or embeddings on the metal nano-particle layer surface; Then, control diffusion layer 7 by the method for dipping at surface-coated one deck macromolecular material of enzyme catalysis layer 6, wherein, it is cellulose acetate, polyurethane, polyurethane, polrvinyl chloride that macromolecular material is selected from usually, any one among the Nafion.
Macromolecular material control diffusion layer 7 can stop the motion of larger molecule because the size in its aperture and the effect of surface group have the selection impregnability, and the diffusion such as albumen in the loss of enzyme and the tissue fluid reduces the interference of electrode.Can also be diffused into by the restriction glucose amount of electrode surface, form the relatively abundant state of oxygen molecule, reduce the dependency of electrode pair oxygen, when increasing the linear sensor scope, can also increase the service life of sensor.
The present invention has increased one deck biodegradable layer 8 at the outermost layer of working electrode 3.Biodegradable layer 8 is comprised of the degradable biocompatibility material, can be the natural degradable material, such as wherein any one of cellulose, chitin, collagen, fibrin; Also can be the synthesized degradable material, such as in polylactic acid, polyglycolic acid and copolymer thereof, polybutylcyanoacrylate, poly-anhydride, polycaprolactone, poly-para-dioxane ketone, poly phosphazene, the polymer-amino-acid any one; It can also be the mixture of natural degradable material and synthesized degradable material.
Biodegradable layer 8 can prevent the loss of enzyme on the one hand as protective material; On the other hand, in the degradation process of material, enzyme is slowly discharged, the enzyme of rear release can remedy the inefficacy of the enzyme that discharges first, degradation rate by the control material, can make the inefficacy of enzyme and the release of enzyme reach balance, thereby make the catalytic efficiency of glucoseoxidase keep constant, form the relay mechanism that enzyme successively discharges.Moreover, after degradable material implants, catabolite is nontoxic, can participate in the metabolism in the body and excrete, the good biocompatibility of material, so the formation of collagen fiber relaxes with respect to non-degradation biological compatibility material, thinner fibrous layer to the barrier effect of glucose a little less than, the sensitivity after sensor is implanted can reduce relatively.In addition, as preferred implementation of the present invention, biodegradable layer 8 can be made into the structure of porous, and the structure of porous can increase the formation of neovascularity, the new blood vessel that forms can improve the seriality of tissue, reduce blood to the distance of sensor, blood also just can be easier to be diffused into sensor surface by sensor measurement, and then sensor just can be measured the change of blood sugar of blood preferably.And the good fibrous tissue that has a large amount of neovascularity to distribute distributes around sensor and also can make sensor long-term stable operation in the situation of not proofreading and correct.
The quantity of working electrode 3 can be one among the present invention, also can be for more than two.
When working electrode 3 was one, biodegradable layer 8 was coated in the outermost regional area of working electrode 3, and the degraded of the biodegradable layer 8 by being distributed in regional area forms the relay mechanism that enzyme successively discharges.
When working electrode 3 is two when above, have at least the outermost layer of a working electrode to be coated with biodegradable layer 8; And having a working electrode 3 at least is to be coated with biodegradable layer 8 at its outermost regional area, perhaps, has at least a working electrode 3 not apply biodegradable layer 8.At this moment, the working electrode 3 that is coated with biodegradable layer 8 can be that whole working electrode 3 all is coated with biodegradable layer 8, also can be only to be coated with biodegradable layer 8 in the subregion of working electrode 3.Degraded by biodegradable layer 8 forms the relay mechanism that enzyme successively discharges.
Fig. 3 and Fig. 4 show the state of subregion that biodegradable layer 8 is coated in the surface of working electrode.At this moment, biodegradable layer 8 can be coated in any position of working electrode 3, and the size of coating can be arbitrarily; The thickness that applies also can be selected according to required degradation time; Can be even coating, also can be inhomogeneous coating, uniform thickened applies as adopting, the stepped mode such as coating that thickens.
Fig. 5 shows a kind of embodiment at the surface-coated biodegradable layer 8 of aciculiform working electrode.As shown in Figure 5, biodegradable layer 8 is coated in the first half section of aciculiform working electrode in uniform mode.Because degradable material is the surface that evenly is coated in working electrode, almost degraded simultaneously in vivo, discharge simultaneously enzyme, take over the enzyme that is about in vivo inefficacy owing to do not apply degradation material glucose response is carried out catalysis, thereby form relay mechanism, increased the service life of glucose sensor.
Fig. 6 shows the sketch map that all applies biodegradable layer 8 on the whole surface of aciculiform working electrode.As shown in Figure 6, biodegradable layer 8 evenly is coated in the outermost layer of whole working electrode, and its painting method is: can first degradable material be made into solution, then evenly be coated in the surface of working electrode by the mode of dipping.
Fig. 7 shows the another kind of embodiment that all applies biodegradable layer 8 on the whole surface of aciculiform working electrode.As shown in Figure 7, on the surface of aciculiform working electrode, biodegradable layer 8 applies from tip to the mode of root with progressive additive of working electrode.Because the thickness of degradation material increases gradually, the degradation time of degradation material also increases successively, and the enzyme catalysis layer is along with the time discharges lentamente, and the new enzyme that discharges is taken over the enzyme that lost efficacy and ran off, can make all the time the enzyme concentration on the working electrode keep constant, glucose response is carried out catalysis.By the degradation time of control biodegradable layer 8, can control the release time of enzyme catalysis layer, thus the service life of prolongation working electrode.
Fig. 8 shows the another kind of embodiment that all applies biodegradable layer 8 on the whole surface of aciculiform working electrode.As shown in Figure 8, on the surface of aciculiform working electrode, biodegradable layer 8 applies from tip to the stepped mode of root of working electrode, so that biodegradable layer 8 is made of stepped regional 8a, 8b, 8c, the 8d that increases progressively of thickness.Can be by the thickness of control biodegradable layer 8 or the time that concentration is come control degradation.Usually, thickness is larger or concentration is higher, and the degradation time of biodegradable layer 8 all can correspondingly increase.By the degradation time of control biodegradable layer 8, can control the release time of enzyme catalysis layer, thus the service life of prolongation working electrode.
Working electrode of the present invention can also be plane electrode except being needle electrode.Fig. 9 shows the sketch map that working electrode is plane electrode.Wherein, the shape of working electrode 3 can have any shape, as circular, oval, square etc.As an available example, select circular working electrode to describe among the present invention.
Figure 10 is the A-A cutaway view of working electrode among Fig. 9, similar to the aciculiform working electrode, wherein, working electrode 3 is made of metal conducting layer 5, enzyme catalysis layer 6, macromolecular material control diffusion layer 7 and biodegradable layer 8, and metal conducting layer 5, enzyme catalysis layer 6, macromolecular material control diffusion layer 7, biodegradable layer 8 distribute by order from inside to outside.The coating method of biodegradable layer 8 can be similar to the coating method of aciculiform working electrode: can be coated in whole working electrode 3 surfaces, also can be to apply in the subregion of working electrode 3; Can evenly be coated in outside the macromolecular material control diffusion layer 7, the mode of the mode (for example stepped with thickness) that also can increase gradually with thickness is coated in outside the macromolecular material control diffusion layer 7.
As shown in figure 11, as another embodiment of the present invention, adopted a plurality of planes working electrode 3, each plane working electrode 3 connects by wire 9.The coating method of biodegradable layer 8 can be similar to the aciculiform working electrode: can in the surface-coated of whole plane working electrode, also can be only to apply in the subregion of plane working electrode; Can be coated in equably outside the macromolecular material control diffusion layer 7, the mode of the mode (for example stepped with thickness) that also can increase gradually with thickness is coated in outside the macromolecular material control diffusion layer 7.
The present invention is owing to the outermost layer at working electrode applies biodegradable layer 8, so that the enzyme catalysis layer 6 of glucose sensor discharges by a kind of relay mechanism, the new enzyme that discharges is taken over the enzyme that lost efficacy and ran off, and can make all the time the enzyme concentration on the working electrode keep constant, and glucose response is carried out catalysis; By the degradation time of control biodegradable layer 8, can control the release time of enzyme catalysis layer 6, thus the service life of prolongation working electrode 3.The glucose sensor of this long service life has broad application prospects in implantation or insertion type blood sugar monitoring field.
Claims (10)
1. glucose sensor comprises be fixedly installed on the pedestal one to electrode (2) and at least one working electrode (3), it is characterized in that: have at least the outermost layer of a described working electrode to be coated with biodegradable layer (8).
2. glucose sensor according to claim 1, it is characterized in that: described working electrode (3) is one, described biodegradable layer (8) covers the outermost regional area of working electrode (3).
3. glucose sensor according to claim 1, it is characterized in that: described working electrode (3) is more than two, and to have a working electrode (3) at least be to be coated with described biodegradable layer (8) at its outermost regional area.
4. each described glucose sensor in 3 according to claim 1 is characterized in that: the thickness of described biodegradable layer (8) is and increases progressively state.
5. glucose sensor according to claim 4, it is characterized in that: the thickness of described biodegradable layer (8) is stepped.
6. glucose sensor according to claim 1, it is characterized in that: described working electrode (3) is more than two, and has at least a working electrode (3) not apply described biodegradable layer.
7. glucose sensor according to claim 6 is characterized in that: the thickness of described biodegradable layer (8) is and increases progressively state.
8. glucose sensor according to claim 7, it is characterized in that: the thickness of described biodegradable layer (8) is stepped.
9. each described glucose sensor in 8 according to claim 1, it is characterized in that: described working electrode comprises metal conducting layer (5), enzyme catalysis layer (6) and macromolecular material control diffusion layer (7), and described metal conducting layer (5), enzyme catalysis layer (6), macromolecular material control diffusion layer (7) distribute by order from inside to outside.
10. each described glucose sensor in 9 according to claim 1, it is characterized in that: described biodegradable layer (8) is loose structure.
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| CN201210416267XA CN102920465A (en) | 2012-10-26 | 2012-10-26 | Glucose sensor |
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| CN201210416267XA CN102920465A (en) | 2012-10-26 | 2012-10-26 | Glucose sensor |
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| CN104049014A (en) * | 2013-03-06 | 2014-09-17 | 霍夫曼-拉罗奇有限公司 | Sensor with Mn2O3 catalyst and process for manufacturing the same |
| CN104535627A (en) * | 2014-12-17 | 2015-04-22 | 浙江大学 | Glucose sensing system |
| CN105411607A (en) * | 2015-11-16 | 2016-03-23 | 杭州亿信网络科技有限公司 | Subcutaneous tissue involvement type glucose microsensor and preparation method thereof |
| CN106645320A (en) * | 2016-11-15 | 2017-05-10 | 中国科学院大学 | Flexible electrode based on biocompatible materials, preparation method of flexible electrode and application |
| CN106618598A (en) * | 2016-11-15 | 2017-05-10 | 惠州市力道电子材料有限公司 | Tungsten alloy micro-needle electrode capable of limiting piercing depth, preparation method thereof, and blood glucose monitoring device |
| CN109085224A (en) * | 2018-08-27 | 2018-12-25 | 浙江大学 | Sensitive microelectrode for cell surface domains ATP detection |
| CN109406589A (en) * | 2018-11-23 | 2019-03-01 | 浙江大学 | A kind of implanted blood sugar test probe and its production method based on silk-screen printing |
| CN110051365A (en) * | 2019-04-23 | 2019-07-26 | 重庆大学 | A kind of implanted electrode for continuing to monitor for a long time |
| CN111272850A (en) * | 2019-08-20 | 2020-06-12 | 深圳硅基传感科技有限公司 | Working electrode of glucose sensor |
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| CN104049014A (en) * | 2013-03-06 | 2014-09-17 | 霍夫曼-拉罗奇有限公司 | Sensor with Mn2O3 catalyst and process for manufacturing the same |
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| CN109406589B (en) * | 2018-11-23 | 2023-07-21 | 浙江大学 | Implantable blood glucose test probe and manufacturing method thereof based on screen printing |
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| CN111272850A (en) * | 2019-08-20 | 2020-06-12 | 深圳硅基传感科技有限公司 | Working electrode of glucose sensor |
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