CN209525297U - A kind of implanted blood sugar test probe - Google Patents
A kind of implanted blood sugar test probe Download PDFInfo
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- CN209525297U CN209525297U CN201821949762.6U CN201821949762U CN209525297U CN 209525297 U CN209525297 U CN 209525297U CN 201821949762 U CN201821949762 U CN 201821949762U CN 209525297 U CN209525297 U CN 209525297U
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Abstract
The utility model discloses a kind of implanted blood sugar test probes, belong to sensor field.The probe is the needle-shaped multi-layer compound structure of strip, and anti-adsorption layer, slow release layer, enzyme layer, insulating layer, electrode layer, base, reference electrode layer, insulating layer, slow release layer and anti-adsorption layer are followed successively by from side to the other side；There is the first uncovered area on the insulating layer being wherein in contact with electrode layer, and be filled with enzyme layer in the first uncovered area, enzyme layer one side is contacted with electrode layer, and another side is wrapped up by slow release layer and being covered；Also there is the second uncovered area on the insulating layer being in contact with reference electrode layer, enzyme layer is not filled in the second uncovered area but be filled with slow release layer.The utility model may be implemented to measure the continuous dynamic of interstitial fluid glucose concentration, and probe small volume and less weight, flexible material reduces user's sense of discomfort, has preferable practical value in implanted blood sugar test field.
Description
Technical field
The utility model relates to a kind of implanted blood glucose measurement probes, belong to sensor field.
Background technique
Diabetes be it is a kind of because caused by internal defect of insulin secretion or histiocytic insulin resistance with hyperglycemia
The metabolic disease being characterized can cause the multiple complications such as cardiovascular disease, chronic renal failure, retinopathy.According to state
Border diabetes alliance (IDF) statistics, the diabetes prevalence of global 20 years old~79 years old adult in 2017 are 8.8%, Huan Zheren
For number up to 4.25 hundred million, the number of patients of China's diabetes is 1.14 hundred million, is ranked the first in the world.Diabetes can not also be controlled completely at present
More, the state of an illness can be effectively controlled by the way that patient blood glucose's concentration is monitored and is controlled, reduces the generation of complication.
There are obvious deficiency, misdiagnosis rate and leakages for currently employed diagnostic method (fasting blood sugar and sugar tolerance experiment)
It is very high to examine rate, and a time point blood glucose can only be surveyed every time, needs repeatedly monitoring blood glucose daily, can not still fully understand blood glucose
Situation is fluctuated, there is an urgent need to more advanced accurate diagnostic instrments by diabetic.Dynamic glucometer can provide continuous blood
Sugared map finds the hyperglycemia and hypoglycemia of " invisible ", provides comprehensive blood sugar for human body parameter information, for examining for diabetes
It is disconnected that accurate comprehensive data are provided, to improve diagnostic level.Facilitate doctor understand diets of diabetic patients, movement, drug,
Influence of the factors such as mood swing to blood glucose level, the reason of finding out blood glucose fluctuation, so that science is formulated or adjustment is corresponding uses
Medicine, diet, movement, monitoring scheme.
Dynamic Blood Glucose Monitoring is mainly the concentration of glucose of liquid between passing through detection subcutaneous tissue, and the glucose of interstitial fluid is dense
Degree changes as blood glucose concentration changes, and has been demonstrated reliably reflect blood glucose level.Probe mainly have by semi-permeable membrane,
Glucose oxidase and microelectrode composition are implanted into subject's subcutaneous abdomen, and the Portugal between subcutaneous tissue in liquid by needle aiding device
Grape sugar occurs chemical reaction and generates electric signal.Dynamic Blood Glucose Monitoring currently on the market mainly uses metal electrode, metal electrode
Higher cost itself, in addition processing method is more complicated, and processing cost is also higher, due to popping one's head on short (the 7 days left sides of body service life
It is right), the average daily consumption of patients is high, therefore is difficult to promote at home.And due to the rigid structure of metal, when implanting
Patient is easily set to generate sense of discomfort.
Summary of the invention
Utility model aims to solve electrode probe production complexity, costs in existing Dynamic Blood Glucose Monitoring technology
Height, and mitigate the sense of discomfort generated by implanted measurement patient, and provide a kind of with new structural blood glucose measurement probe
And preparation method thereof.
Specific technical solution used by the utility model is as follows:
A kind of implanted blood sugar test probe, which is the needle-shaped multi-layer compound structure of strip, from side to the other side
It is followed successively by anti-adsorption layer, slow release layer, insulating layer, electrode layer, base, reference electrode layer, insulating layer, slow release layer and anti-absorption
Layer；There is the first uncovered area on the insulating layer being wherein in contact with electrode layer, and filled in the first uncovered area
There is enzyme layer, enzyme layer one side is contacted with electrode layer, and another side is wrapped up by slow release layer and being covered；It is in contact with reference electrode layer exhausted
Also there is the second uncovered area in edge layer, enzyme layer is not filled in the second uncovered area but be filled with slow release layer.
Preferably, the anti-adsorption layer is poly-sulphonic acid betaine (pSBMA), electrode surface can be solved because protein is inhaled
It is attached, it causes that electrode sensitivity is caused to reduce, signal reaction delay, or even failure.
Preferably, the sustained release layer material is poly lactide-glycolide acid (PLGA).For glucose electrode
In the problem that the body running service life is short, the invention proposes a kind of structural design schemes of enzyme controlled release relay mechanism, that is, coat
Poly lactide-glycolide acid (PLGA) gradually discharges glucose oxidase and participates in catalysis in the degradation process of the material
Reaction, to maintain the stability of transducer sensitivity.
Preferably, the matrix of the enzyme layer is the polyaniline in reticular structure, fixed in the reticular structure of polyaniline
There is glucose oxidase (GOD).Fixing glucose oxidase (GOD) on the polyaniline of reticular structure, is conducive to consolidating for enzyme
?.
Preferably, the insulating layer material is ink (PET INK).
Preferably, there are two the Wiring areas for not covering insulating layer respectively in the electrode layer and reference electrode layer
Domain, for being contacted with external contact.
Preferably, the wire area in the electrode layer and reference electrode layer mutually staggers, to avoid outside
Contact contacts with each other cause short circuit here.
Preferably, electrode layer is Prussian blue modified electrode, the reference electrode layer is silver chloride electrode.
Preferably, the base is polyethylene terephthalate (PET) material.Due to the poly- terephthaldehyde of base
Sour glycol ester (PET) flexibility characteristics can effectively reduce the sense of discomfort of patient in implanted measurement process.
Preferably, the probe length is 1.5~2.5 centimetres, width is at 200 microns hereinafter, thickness is at 200 microns
Below.
The utility model may be implemented to measure the continuous dynamic of interstitial fluid glucose concentration, and probe small volume and less weight is flexible
Material reduces user's sense of discomfort.The utility model can be made by silk-screen printing technique, can simplify procedure of processing, drop
Low processing cost is conducive to the realization of large-scale production processing, has preferable practical value in implanted blood sugar test field.
Detailed description of the invention
Fig. 1 is the schematic diagram of the section structure of the implanted blood sugar test probe based on silk-screen printing；
Fig. 2 is the production process schematic diagram of the implanted blood sugar test probe based on silk-screen printing；
Fig. 3 is the production process schematic diagram of the implanted blood sugar test probe based on silk-screen printing；
Fig. 4 is the production process schematic diagram of the implanted blood sugar test probe based on silk-screen printing；
Fig. 5 is the production process schematic diagram of the implanted blood sugar test probe based on silk-screen printing；
Fig. 6 is the production process schematic diagram of the implanted blood sugar test probe based on silk-screen printing；
Fig. 7 is the production process schematic diagram of the implanted blood sugar test probe based on silk-screen printing；
Fig. 8 is the cross-sectional structure schematic diagram of the implanted blood sugar test probe based on silk-screen printing.
Appended drawing reference in figure, anti-adsorption layer 1, slow release layer 2, enzyme layer 3, insulating layer 4, electrode layer 5, base 6, reference electricity
Pole layer 7, wire area 8, contact 9, crop box 10, cross section 11.
Specific embodiment
The utility model is further elaborated and is illustrated with reference to the accompanying drawings and detailed description.In the utility model
The technical characteristic of each embodiment can carry out the corresponding combination under the premise of not conflicting with each other.
As shown in Figure 1, being the schematic diagram of the section structure of the implanted blood sugar test probe based on silk-screen printing.The probe is
The needle-shaped multi-layer compound structure of strip is followed successively by anti-adsorption layer 1, slow release layer 2, insulating layer 4, working electrode from side to the other side
Layer 5, base 6, reference electrode layer 7, insulating layer 4, slow release layer 2 and anti-adsorption layer 1.It is wherein in contact with electrode layer 5 exhausted
There is the first uncovered area in edge layer 4,
5 surface of electrode layer in the regional scope is not covered with insulating layer 4, and is filled in the first uncovered area
Enzyme layer 3,3 one side of enzyme layer are contacted with electrode layer 5, and another side is wrapped up by slow release layer 2 and being covered.And connect with reference electrode layer 7
Also there is the second uncovered area, 5 surface of electrode layer in the regional scope is exhausted also without covering on the insulating layer 4 of touching
Edge layer 4, but without filling enzyme layer 3 in the second uncovered area, but directly fill full slow release layer 2.In addition, electrode layer
5 and reference electrode layer 7 on respectively there are two not covering the wire area 8 of insulating layer 4, for external electrochemical detection device
Contact 9 contacts.In view of the probe overall dimensions are smaller, if two wire areas 8, which are closer, is easy to produce short circuit, therefore answer
Two wire areas are made to be staggered position each other as far as possible.Certainly, electrode layer 5 and reference electrode layer 7 can also be using others
Gage system, as long as electrochemical signals can be exported outward.
In the probe, enzyme layer 3 is using the enzyme that can generate redox reaction with the glucose in tissue fluid.Work as electrode
When entering human body by guide pin, the glucose in tissue fluid is contacted by anti-adsorption layer 1 with slow release layer 2 with enzyme layer 3.In enzyme layer 3
Glucose oxidase (GOD) by breakdown of glucose be gluconic acid and hydrogen peroxide, decomposing hydrogen dioxide solution generate it is corresponding to glucose
Electronics 2e-, generate potential difference between working electrode 5 and reference electrode layer 7, this electric signal conducts upwards, can reflect group
Knit the concentration of glucose in liquid.The concentration of glucose of interstitial fluid changes as blood glucose concentration changes, and has been demonstrated
It can reliably reflect blood glucose level.
The specific material of above layers structure, which can according to need, to be selected, and in the present embodiment, anti-adsorption layer 1 is super
Low nonspecific proteins adsorption gel material poly-sulphonic acid betaine (pSBMA).2 material of slow release layer is total for poly lactic-co-glycolic acid
Polymers (PLGA).The matrix of enzyme layer 3 is the polyaniline in reticular structure, and attachment is fixed with glucose in the reticular structure of polyaniline
Oxidizing ferment (GOD).4 material of insulating layer is ink (PET INK).The material of electrode layer 5 is carbon dust and Prussian blue, ginseng
It is silver chlorate than 7 material of electrode layer.Base 6 is polyethylene terephthalate (PET) material.In view of easily manufactured, on
Stating anti-adsorption layer 1 can be polymerize outside slow release layer 2 by electrochemistry controllable polymerization (ATRP) mode.Slow release layer 2 can pass through
Coating method is attached to outside slow release layer 2 and enzyme layer 3.Polyaniline in enzyme layer 3 can be plated on first by plating mode and not cover
In cover area, then enzyme is fixed in tube/polyaniline netty structure or surface by way of dry after impregnating again.Insulating layer 4
It can be printed on by way of silk-screen printing outside electrode layer 5 and reference electrode layer 7.Electrode layer 5 and reference electricity
Pole layer 7 can be printed on 6 two sides of base by screen printing mode.
In the degradation process of 2 poly lactide-glycolide acid of slow release layer (PLGA), glucose oxidase is gradually discharged
Catalysis reaction is participated in, to maintain the stability of transducer sensitivity.It plants and intervenes in anti-1 surface electrochemistry controllable polymerization of adsorption layer
Ultralow protein adsorption hydrogel material poly-sulphonic acid betaine (pSBMA) can solve the absorption of electrode surface protein, cause electrode clever
Sensitivity reduces, signal reaction delay, or even the problem of failure.
But it should be recognized that the above-mentioned fixed form of these structure sheafs is used only for auxiliary those skilled in the art's reason
Solution, but its implementation is not limited only to this, as long as theoretically its multilayered structure for forming the utility model realizes phase
Same function.For example, the enzyme in enzyme layer 3 can be using other fixed forms, as long as can make glucose in tissue fluid
Oxidizing ferment participates in breakdown of glucose reaction.Similarly the specific material of above layers structure, which also can according to need, is adjusted
It is whole, as long as it can play similar effect.Moreover, existing commercially available material can be used in the material in above structure layer
Material.When necessary, part-structure layer can also be substituted using commercially available commercial product, such as electrode layer 5 can use
It is commercially for the Prussian blue modified electrode of detection glucose, the reference electrode layer 7 of silver chlorate similarly has commercial product,
It does not limit this.
The probe length is at 2 centimetres or so, and width is at 200 microns hereinafter, thickness is slightly different because of manufacture craft, generally
At 200 microns hereinafter, in the subcutaneous tissue that easily user can be implanted into.
It is illustrated in figure 2 the production process schematic diagram of the implanted blood sugar test probe based on silk-screen printing, first to PET base
Layer 6 is cut in advance and ultrasonic cleaning, drying, then prints upper carbonaceous powder and Prussian blue mixture in the one side of PET base 6
Working electrode 5, the silver chloride reference electrode layer 7 that another side is printed, two area size shapes are consistent and are overlapped, such as Fig. 2 .b)
Shown in section.Due to the high efficiency of silk-screen printing, single printing can manufacture multiple double-face electrode layers, Fig. 2 in a PET base 6
The printing area of only one unit.
It is illustrated in figure 3 the production process schematic diagram of the implanted blood sugar test probe based on silk-screen printing, in work electricity
Insulating layer in the 7 outside silk-screen printing of pole 5 and reference electrode layer.Such as Fig. 3 .a) shown in, two-sided insulating layer is by three pieces of rectangles
Region is constituted.Lower two pieces it is interregional between be divided into the part of working electrode 5 and reference electrode layer 7 and tissue fluid mediate contact, on
Wire area 8 between two pieces of regions is the part that contacts with external contact of probe, and position is staggered each other, avoid it is short-circuit can
Can, such as Fig. 3 .b) shown in.Due to the high efficiency of silk-screen printing, three pieces of insulating layers 4 between different units can print simultaneously, letter
Procedure of processing is changed.
It is illustrated in figure 4 the production process schematic diagram of the implanted blood sugar test probe based on silk-screen printing, more precisely
Say it is to cut out the process of independent probes monomer along crop box 10 from 5 plate of a Kuai great PET base.It is cut out on a unit
The region for cutting 2 centimetres * 200 microns, such as Fig. 4 .a) and Fig. 4 .b) shown in, so that it is insulation that last probe monomer structure, which is both ends,
Layer guarantees the wire area 8 contacted with electric shock with the part of working electrode 5 and reference electrode layer 7 and tissue fluid mediate contact not
In the end of probe, a possibility that short-circuit is reduced.
It is illustrated in figure 5 the production process schematic diagram of the implanted blood sugar test probe based on silk-screen printing, uses 0.4mol
Aniline: 1mol sulfuric acid, constant current 0.1mA, energization 600s do not cover the first uncovered area of insulating layer in electrode layer 5
The polyaniline of the interior upper one layer of reticular structure of plating, then allow enzyme to be fixed on reticular structure by way of immersion, form enzyme layer 3.
It is illustrated in figure 6 the production process schematic diagram of the implanted blood sugar test probe based on silk-screen printing, by visiting
It is applied below needle and is covered with a strata poly lactic coglycolic acid (PLGA), form the slow release layer 2 of whole package probe lower end.?
In the degradation process of 2 poly lactide-glycolide acid of slow release layer (PLGA), gradually discharges glucose oxidase and participate in catalysis instead
It answers, to maintain the stability of transducer sensitivity.
It is illustrated in figure 7 the production process schematic diagram of the implanted blood sugar test probe based on silk-screen printing, anti-adsorption layer 1
Surface electrochemistry controllable polymerization (reference electrode layer 7 is also connect with working electrode 5 by electropolymerization process), which is planted, intervenes ultralow albumen suction
Attached water gel rubber material poly-sulphonic acid betaine (pSBMA) can solve the absorption of electrode surface protein, and electrode sensitivity is caused to reduce, and believe
Number reaction delay, or even failure the problem of.
Fig. 8 be the implanted blood sugar test probe based on silk-screen printing cross-sectional structure schematic diagram, Fig. 8 .b) be along
Fig. 8 .a) in cross section 11 structure chart, outermost layer be anti-adsorption layer 1, this outer layer be slow release layer 2.When electrode passes through guide pin
When into human body, the glucose in tissue fluid is contacted by anti-adsorption layer 1 with slow release layer 2 with enzyme layer 3.Glucose in enzyme layer 3
Breakdown of glucose is gluconic acid and hydrogen peroxide by oxidizing ferment (GOD), and decomposing hydrogen dioxide solution generates electronics corresponding with glucose
2e- generates potential difference between working electrode 5 and reference electrode layer 7, this electric signal conducts upwards, can reflect in tissue fluid
Concentration of glucose.The concentration of glucose of interstitial fluid changes as blood glucose concentration changes, and having been demonstrated can be reliable
Reflect blood glucose level.
The manufacturing process of above-mentioned implanted blood sugar test probe is specific as follows by step point:
1) one side with screen printing technique in base 6 prints carbon dust and Prussian blue mixed electrode layer 5,
The reference electrode layer 7 of another side printing silver chloride material；
2) the screen printing technique insulating layer of double-sided printing with ink (PET INK) for material on the basis of step 1) is used
4, and respectively stay on the insulating layer of two sides 4 that there are two the regions for not covering insulating layer 4；Then it is carried out according to the size of every probe
It cuts, obtains probe monomer；Have first not cover in every probe monomer, on the insulating layer 4 that is in contact with electrode layer 5
Region has the second uncovered area on the insulating layer 4 being in contact with reference electrode layer 7, and remaining two do not cover insulating layer 4
Region is as wire area 8, for contacting with external contact 9；
3) on the basis of the probe monomer that step 2) obtains, do not cover insulating layer in electrode layer 5 first is not covered
The polyaniline of one layer of reticular structure is electroplated in cover area, then glucose oxidase is attached to fixed in reticular structure；
4) it on the basis of step 3), is applied by way of coating in probe lower end and is covered with one layer with polylactic acid-glycolic base second
Acid copolymer is the slow release layer 2 of material, and slow release layer 2 is wrapped in outside the polyaniline of reticular structure, while filling second and not covering
Cover area；
5) anti-by pSBMA on electrochemistry controllable polymerization outside the slow release layer 2 of probe lower end on the basis of step 4)
Adsorption layer 1 obtains implanted blood sugar test probe.
The present embodiment may be implemented to measure the continuous dynamic of interstitial fluid glucose concentration, probe small volume and less weight, flexible material
Material reduces user's sense of discomfort, and the technique of silk-screen printing can simplify procedure of processing, reduce processing cost, is conducive to large-scale production and adds
The realization of work has preferable practical value in implanted blood sugar test field.
Embodiment described above is a kind of preferable scheme of the utility model, and so it is not practical to limit
It is novel.Those of ordinary skill in related technical field can be in the case where not departing from the spirit and scope of the utility model
It makes a variety of changes and modification.Therefore all mode technical solutions obtained for taking equivalent substitution or equivalent transformation, all fall within
In the protection scope of the utility model.
Claims (10)
1. a kind of implanted blood sugar test probe, it is characterised in that: the probe is the needle-shaped multi-layer compound structure of strip, from side
Anti- adsorption layer (1), slow release layer (2), insulating layer (4), electrode layer (5), base (6), reference electrode are followed successively by the other side
Layer (7), insulating layer (4), slow release layer (2) and anti-adsorption layer (1)；On the insulating layer (4) being wherein in contact with electrode layer (5)
With the first uncovered area, and in the first uncovered area be filled with enzyme layer (3), enzyme layer (3) on one side with electrode layer (5)
Contact, another side are wrapped up by slow release layer (2) and being covered；Also do not have second not on the insulating layer (4) being in contact with reference electrode layer (7)
Overlay area without filling enzyme layer (3) but is filled with slow release layer (2) in the second uncovered area.
2. implanted blood sugar test probe as described in claim 1, which is characterized in that the anti-adsorption layer (1) is polysulfonate
Sour glycine betaine.
3. implanted blood sugar test probe as described in claim 1, which is characterized in that described slow release layer (2) material is poly-
Poly lactic coglycolic acid.
4. implanted blood sugar test probe as described in claim 1, which is characterized in that the matrix of the enzyme layer (3) be in
The polyaniline of reticular structure is fixed with glucose oxidase in the reticular structure of polyaniline.
5. implanted blood sugar test probe as described in claim 1, which is characterized in that insulating layer (4) material is oil
Ink.
6. implanted blood sugar test probe as described in claim 1, which is characterized in that the electrode layer (5) and ginseng
Than there is the wire area for not covering insulating layer (4) (8) on electrode layer (7) respectively, for being contacted with external contact (9).
7. implanted blood sugar test probe as claimed in claim 6, which is characterized in that the electrode layer (5) and reference
Wire area (8) on electrode layer (7) mutually staggers.
8. implanted blood sugar test probe as described in claim 1, which is characterized in that the electrode layer (5) is
Prussian blue modified electrode, the reference electrode layer (7) are silver chloride electrode.
9. implanted blood sugar test probe as described in claim 1, which is characterized in that the base (6) is poly- to benzene two
Formic acid glycol ester material.
10. implanted blood sugar test probe as described in claim 1, which is characterized in that the probe length is 1.5 ~ 2.5 lis
Rice, width is at 200 microns hereinafter, thickness is at 200 microns or less.
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| CN201821949762.6U CN209525297U (en) | 2018-11-23 | 2018-11-23 | A kind of implanted blood sugar test probe |
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| 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 |
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2018
- 2018-11-23 CN CN201821949762.6U patent/CN209525297U/en active Active
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| 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 |
| 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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