CN109765286A - A kind of Continuous Glucose monitoring system sensor and preparation method thereof - Google Patents
A kind of Continuous Glucose monitoring system sensor and preparation method thereof Download PDFInfo
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- CN109765286A CN109765286A CN201910175029.6A CN201910175029A CN109765286A CN 109765286 A CN109765286 A CN 109765286A CN 201910175029 A CN201910175029 A CN 201910175029A CN 109765286 A CN109765286 A CN 109765286A
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Abstract
The invention discloses a kind of production methods of Continuous Glucose monitoring system sensor, and by being alternately stacked conductive layer and insulating layer on matrix by preset order, the conductive layer and the insulating layer are conductive layer and insulating layer made of biocompatible materials;In predeterminable area aperture, obtain hole, the inner wall of described hole exposes corresponding conductive layer, the inner wall of each described hole only with a conductive layer contact;Enzyme layer is set in the hole obtained after aperture, and the enzyme layer is used to generate electric current with glucose response;Film layer is set in the hole that the enzyme layer was set, and the film layer has permeability to glucose;Described matrix is cut, multiple Continuous Glucose monitoring system sensors are obtained.The present invention can be reduced production cost, be improved production efficiency before cutting with batch setting described hole.A kind of Continuous Glucose monitoring system sensor and a kind of Continuous Glucose monitoring system with above-mentioned beneficial effect are also provided simultaneously.
Description
Technical field
The present invention relates to intelligent medical fields, monitor system sensor and its production more particularly to a kind of Continuous Glucose
Method, Continuous Glucose monitor system.
Background technique
In recent years, with the development of science and technology, demand of the people to medical services is also increasingly improving, as a result, intelligence
The concept of medical treatment is come into being, and intelligent medical is to utilize state-of-the-art object by making health account area medical information platform
Networking technology realizes patient and interacting between medical worker, medical institutions, Medical Devices, progressively reaches informationization.And it is specific
The diabetes multiple to modern, blood sugar monitoring are its important components, and the result of blood sugar monitoring helps to assess diabetes
The degree of patient's carbohydrate metabolism disturbance formulates reasonable hypoglycemic scheme, the variation of the follow-up state of an illness and the tune of guiding treatment scheme
It is whole.Patient carries out the citation form that Blood sugar self-measure (SMBG) is blood sugar monitoring, and glycosylated hemoglobin (HbA1c) is reflection
The goldstandard of long-term blood glucose control average level.
Common Continuous Glucose monitors system sensor on the market in front, one is acicular one is sheet, has
Be printing have plenty of photoengraving, however, which kind of, the preparation of these sensors requires first to be cut into single electrode
It goes to apply enzyme or film again, if height is required to accuracy of machines using machine batch operation, if using manual operation low efficiency, no
It is very high by which kind of method cost.
Summary of the invention
The object of the present invention is to provide a kind of production methods of Continuous Glucose monitoring system sensor, to solve existing skill
Complex manufacturing technology in art, at high cost, required precision is high, needs the problem of spending a large amount of manpowers.The present invention goes back while providing
A kind of Continuous Glucose monitoring system sensor and a kind of Continuous Glucose with above-mentioned beneficial effect monitor system.
In order to solve the above technical problems, the present invention provides a kind of production method of Continuous Glucose monitoring system sensor,
Include:
It alternately is stacked conductive layer and insulating layer on matrix by preset order, the conductive layer is with the insulating layer
Conductive layer and insulating layer made of biocompatible materials;
In predeterminable area aperture, hole is obtained, the inner wall of described hole exposes corresponding conductive layer, each described hole
The inner wall in hole only with a conductive layer contact;
Enzyme layer is set in the hole obtained after aperture, and the enzyme layer is used to generate electric current with glucose response;
Film layer is set in the hole that the enzyme layer was set, and the film layer has permeability to glucose;
Described matrix is cut, multiple Continuous Glucose monitoring system sensors are obtained.
Optionally, in the production method of above-mentioned Continuous Glucose monitoring system sensor, each corresponding described conduction
Layer has multiple described holes.
Optionally, in the production method of above-mentioned Continuous Glucose monitoring system sensor, the different conductive layers are corresponding
Hole area it is identical.
Optionally, in the production method of above-mentioned Continuous Glucose monitoring system sensor, the enzyme layer and the film layer
It is to be obtained by mode for dispensing glue.
Optionally, in the production method of above-mentioned Continuous Glucose monitoring system sensor, the thickness of the insulating layer
Range is 0.005 millimeter to 0.200 millimeter, including endpoint value.
Optionally, in the production method of above-mentioned Continuous Glucose monitoring system sensor, described hole is circular hole.
Optionally, in the production method of above-mentioned Continuous Glucose monitoring system sensor, the conductive layer can lead for carbon
Electric layer or silver conductive layer or golden conductive layer or platinum conductive layer.
Optionally, in the production method of above-mentioned Continuous Glucose monitoring system sensor, the insulating layer can be polyamides
Imines insulating layer or Parylene insulating layer or polyurethane insulating layer.
The production method of Continuous Glucose monitoring system sensor provided by the present invention, by pressing preset order in matrix
Upper alternating is stacked conductive layer and insulating layer, and the conductive layer and the insulating layer are conduction made of biocompatible materials
Layer and insulating layer;In predeterminable area aperture, hole is obtained, the inner wall of described hole exposes corresponding conductive layer, each institute
State the inner wall of hole only with a conductive layer contact;Enzyme layer is set in the hole obtained after aperture, and the enzyme layer is used for and Portugal
The reaction of grape sugar generates electric current;Film layer is set in the hole that the enzyme layer was set, and the film layer has permeability to glucose;It is right
Described matrix is cut, and multiple Continuous Glucose monitoring system sensors are obtained.The present invention is with biocompatibility
Conductive layer and insulating layer on the conversion zone of porous is set, make Continuous Glucose monitoring system sensor before cutting
It can be clipped later to obtain in batch with the enzyme layer and the film layer inside batch setting described hole and described hole
Finished product the Continuous Glucose monitor system sensor, without as in the prior art cut after successively by being manually arranged
Enzyme layer and film layer, or using the machine setting enzyme layer and film layer of high precision, production cost is reduced, improve production effect
Rate.
Detailed description of the invention
It, below will be to embodiment or existing for the clearer technical solution for illustrating the embodiment of the present invention or the prior art
Attached drawing needed in technical description is briefly described, it should be apparent that, the accompanying drawings in the following description is only this hair
Bright some embodiments for those of ordinary skill in the art without creative efforts, can be with root
Other attached drawings are obtained according to these attached drawings.
Fig. 1 is a kind of specific embodiment party for the production method that Continuous Glucose provided by the present invention monitors system sensor
The flow diagram of formula;
Fig. 2 is another specific implementation for the production method that Continuous Glucose provided by the present invention monitors system sensor
The flow diagram of mode;
Fig. 3 is another specific implementation for the production method that Continuous Glucose provided by the present invention monitors system sensor
The flow diagram of mode;
Fig. 4 is that a kind of structure for specific embodiment that Continuous Glucose provided by the present invention monitors system sensor is shown
It is intended to;
Fig. 5 is that a kind of structure for specific embodiment that Continuous Glucose provided by the present invention monitors system sensor is quick-fried
Fried figure;
Fig. 6 is the flow chart for the level setting that Continuous Glucose provided by the present invention monitors system sensor.
Specific embodiment
Continuous Glucose in the prior art monitors system sensor, most of for by the material for not having bioaffinity
Sensor made of expecting, therefore cannot directly and human contact, and then the electrode for the full packaging type that must be used, i.e., by electrode layer
With insulating layer is alternately laminated set after, be directly cut into needle-shaped perhaps sheet immerse in enzyme solution or film liquid obtain enzyme layer or
Film layer passes through above-mentioned enzyme layer and above-mentioned film layer and direct body contact.
To realize above structure, existing Continuous Glucose monitoring system sensor, which passes through, is first cut into single electrode again
It goes to apply enzyme or the mode of film obtains, but because of single electrode small volume, it can only be very high by artificial coating or precision
Machine coating, wherein artificial recoating efficiency is low, machine coating cost is excessively high, is required to largely put into.
In order to enable those skilled in the art to better understand the solution of the present invention, with reference to the accompanying drawings and detailed description
The present invention is described in further detail.Obviously, described embodiments are only a part of the embodiments of the present invention, rather than
Whole embodiments.Based on the embodiments of the present invention, those of ordinary skill in the art are not making creative work premise
Under every other embodiment obtained, shall fall within the protection scope of the present invention.
The production method that core of the invention is to provide a kind of Continuous Glucose monitoring system sensor, a kind of specific reality
The flow diagram of mode is applied as shown in Figure 1, being called specific embodiment one, comprising:
Step S101: being alternately stacked conductive layer and insulating layer on matrix by preset order, above-mentioned conductive layer with it is upper
Stating insulating layer is conductive layer and insulating layer made of biocompatible materials.
Step S102: in predeterminable area aperture, hole is obtained, the inner wall of above-mentioned hole exposes corresponding conductive layer, often
The inner wall of one above-mentioned hole only with a conductive layer contact.
Step S103: being arranged enzyme layer in the hole obtained after aperture, above-mentioned enzyme layer is used to generate electricity with glucose response
Stream.
Step S104: being arranged film layer in the hole that above-mentioned enzyme layer was arranged, and above-mentioned film layer has permeability to glucose.
Step S105: cutting above-mentioned matrix, obtains multiple above-mentioned Continuous Glucose monitoring system sensors.
It should be noted that above-mentioned film layer can also be further divided into theca externa and theca interna, it is separately positioned on above-mentioned enzyme layer
Two sides;Above-mentioned theca externa can for layer of polyurethane or polycarbonate, polyester layer or thermoplastic silicone polyether-polyurethane layer or
Nafion layers.
In addition, the range of the thickness of above-mentioned insulating layer is 0.005 millimeter to 0.200 millimeter, including endpoint value, such as 0.0050
Any of millimeter, 0.1025 millimeter or 0.2000 millimeter.
Particularly, above-mentioned hole is also possible to pre-set on above-mentioned conductive layer and above-mentioned insulating layer, i.e., first exists
Above-mentioned hole is pre-set on above-mentioned conductive layer and above-mentioned insulating layer, then above-mentioned conductive layer and above-mentioned insulating layer is alternately laminated
It sets up, step S101 and step S102 can not influence the final effect of finished product with exchange sequence.
Above-mentioned matrix has good biocompatibility, such as polyimides, polyurethane, PET or PEK;And the range of thickness is
0.05 millimeter to 0.50 millimeter, including endpoint value, such as any of 0.050 millimeter, 0.350 millimeter or 0.500 millimeter.
The range of the width of above-mentioned Continuous Glucose monitoring system sensor is 0.10 millimeter to 0.50 millimeter, including endpoint
Value, such as any of 0.100 millimeter, 0.130 millimeter or 0.500 millimeter, preferably 0.3 millimeter of the application;Do not influencing monitoring effect
Sensor width is minimized under the premise of fruit, to reduce the wound in electrode implantation.
Further, above-mentioned hole is circular hole.
It should be noted that above-mentioned conductive layer can be carbonaceous conductive layer or silver conductive layer or golden conductive layer or platinum conductive layer;On
Stating insulating layer can be polyimide insulative layer or Parylene insulating layer or polyurethane insulating layer.
The production method of Continuous Glucose monitoring system sensor provided by the present invention, by pressing preset order in matrix
Upper alternating is stacked conductive layer and insulating layer, and above-mentioned conductive layer and above-mentioned insulating layer are conduction made of biocompatible materials
Layer and insulating layer;In predeterminable area aperture, hole is obtained, the inner wall of above-mentioned hole exposes corresponding conductive layer, on each
State the inner wall of hole only with a conductive layer contact;Enzyme layer is set in the hole obtained after aperture, and above-mentioned enzyme layer is used for and Portugal
The reaction of grape sugar generates electric current;Film layer is set in the hole that above-mentioned enzyme layer was set, and above-mentioned film layer has permeability to glucose;It is right
Above-mentioned matrix is cut, and multiple above-mentioned Continuous Glucose monitoring system sensors are obtained.The present invention is with biocompatibility
Conductive layer and insulating layer on the conversion zone of porous is set, make above-mentioned Continuous Glucose monitoring system sensor before cutting
It can be clipped later to obtain in batch with the above-mentioned enzyme layer and above-mentioned film layer inside the above-mentioned hole of batch setting and above-mentioned hole
Finished product above-mentioned Continuous Glucose monitor system sensor, without as in the prior art cut after successively by being manually arranged
Enzyme layer and film layer, or using the machine setting enzyme layer and film layer of high precision, production cost is reduced, improve production effect
Rate.
On the basis of specific embodiment one, further on above-mentioned Continuous Glucose monitoring system sensor conductive layer
Hole limit, obtain specific embodiment two, flow diagram is as shown in Figure 2, comprising:
Step S201: being alternately stacked conductive layer and insulating layer on matrix by preset order, above-mentioned conductive layer with it is upper
Stating insulating layer is conductive layer and insulating layer made of biocompatible materials.
Step S202: in predeterminable area aperture, hole is obtained, the inner wall of above-mentioned hole exposes corresponding conductive layer, often
The inner wall of one above-mentioned hole only with a conductive layer contact, wherein each corresponding above-mentioned conductive layer has multiple above-mentioned holes
Hole.
Step S203: being arranged enzyme layer in the hole obtained after aperture, above-mentioned enzyme layer is used to generate electricity with glucose response
Stream.
Step S204: being arranged film layer in the hole that above-mentioned enzyme layer was arranged, and above-mentioned film layer has permeability to glucose.
Step S205: cutting above-mentioned matrix, obtains multiple above-mentioned Continuous Glucose monitoring system sensors.
Present embodiment and above-mentioned specific embodiment the difference is that, present embodiment defines
The quantity of hole is stated, remaining structure is identical as above-mentioned specific embodiment, not reinflated herein to repeat.
Multiple above-mentioned holes are provided in present embodiment in each conductive layer, are increased and human body fluid
Contact area reduces the probability that above-mentioned hole is wrapped up by immunocyte, ensure that above-mentioned Continuous Glucose monitoring system sensing
The job stability of device.
On the basis of specific embodiment two, further the set-up mode of above-mentioned enzyme layer and above-mentioned film layer is limited,
Specific embodiment three is obtained, flow diagram is as shown in Figure 3, comprising:
Step S301: being alternately stacked conductive layer and insulating layer on matrix by preset order, above-mentioned conductive layer with it is upper
Stating insulating layer is conductive layer and insulating layer made of biocompatible materials.
Step S302: in predeterminable area aperture, hole is obtained, the inner wall of above-mentioned hole exposes corresponding conductive layer, often
The inner wall of one above-mentioned hole only with a conductive layer contact, wherein each corresponding above-mentioned conductive layer has multiple above-mentioned holes
The area in hole, the corresponding hole of the above-mentioned conductive layer of difference is identical.
Step S303: enzyme layer is arranged by mode for dispensing glue in the hole obtained after aperture, above-mentioned enzyme layer is used for and Portugal
The reaction of grape sugar generates electric current.
Step S304: film layer is arranged by mode for dispensing glue in the hole that above-mentioned enzyme layer was set, above-mentioned film layer is to Portugal
Grape sugar has permeability.
Step S305: cutting above-mentioned matrix, obtains multiple above-mentioned Continuous Glucose monitoring system sensors.
Present embodiment and above-mentioned specific embodiment the difference is that, present embodiment is further advised
The set-up mode and the hole size on different conductive layers for having determined above-mentioned enzyme layer and above-mentioned film layer, remaining step with it is above-mentioned specific
Embodiment is identical, not reinflated herein to repeat.
Further, present embodiment realizes dispensing by precise glue dispensing machine, since the area of above-mentioned hole is equal
It is consistent, therefore after injecting the above-mentioned enzyme layer of equivalent or the raw material of above-mentioned film layer into above-mentioned hole by precise glue dispensing machine,
The consistency of thickness of the above-mentioned enzyme layer obtained in each hole or above-mentioned film layer, so that the glucose in each above-mentioned hole passes through
Rate is identical, substantially increases the consistency of sensor so that the key performance of sensor exempt from correction simplify it is subsequent
Process flow improves production efficiency.
The present invention also provides a kind of Continuous Glucoses to monitor system sensor, and above-mentioned Continuous Glucose monitors system sensing
Device is that the Continuous Glucose obtained by the above-mentioned production method of any of the above-described monitors system sensor, a kind of specific implementation
The structural schematic diagram of mode is as shown in figure 4, corresponding Structure explosion diagram is as shown in Figure 5.
As a kind of specific embodiment of Continuous Glucose provided by the present invention monitoring system sensor, above-mentioned conduction
At least two layers of layer, optimum selecting three-layer;Above-mentioned insulating layer is also at least two layers, optimum selecting three-layer;Also, the second conductive layer is first
Rear a distance of insulating layer starts, i.e., it is not by the second conduction that the head end of the first conductive layer and the first insulating layer, which has one section,
What layer and second insulating layer covered;In other words, each layer of above-mentioned conductive layer and corresponding above-mentioned insulating layer constitute head end pair
Neat step, multipair above-mentioned conductive layer and above-mentioned insulating layer form multi-step.
System sensor is monitored according to the Continuous Glucose in Fig. 4 and Fig. 5, a kind of each of the sensor is now provided and is led
The setting procedure of electric layer and insulating layer is illustrated, and the structural schematic diagram after each step is as shown in Figure 6:
Step T1: the first conductive layer, the first conduction region in above-mentioned first conductive layer corresponding diagram 4 are printed on matrix.
Step T2: the first insulating layer, the first insulation layer in above-mentioned first insulating layer corresponding diagram 4 are printed.
Step T3: the second conductive layer, the second conduction region in above-mentioned second conductive layer corresponding diagram 4 are printed.
Step T4: second insulating layer, the second insulation layer in above-mentioned second insulating layer corresponding diagram 4 are printed.
Step T5: third conductive layer, the third conduction region in above-mentioned third conductive layer corresponding diagram 4 are printed.
Step T6: third insulating layer, the third insulation layer in above-mentioned third insulating layer corresponding diagram 4 are printed.
The production method of Continuous Glucose monitoring system sensor provided by the present invention, by pressing preset order in matrix
Upper alternating is stacked conductive layer and insulating layer, and above-mentioned conductive layer and above-mentioned insulating layer are conduction made of biocompatible materials
Layer and insulating layer;In predeterminable area aperture, hole is obtained, the inner wall of above-mentioned hole exposes corresponding conductive layer, on each
State the inner wall of hole only with a conductive layer contact;Enzyme layer is set in the hole obtained after aperture, and above-mentioned enzyme layer is used for and Portugal
The reaction of grape sugar generates electric current;Film layer is set in the hole that above-mentioned enzyme layer was set, and above-mentioned film layer has permeability to glucose;It is right
Above-mentioned matrix is cut, and multiple above-mentioned Continuous Glucose monitoring system sensors are obtained.The present invention is with biocompatibility
Conductive layer and insulating layer on the conversion zone of porous is set, make above-mentioned Continuous Glucose monitoring system sensor before cutting
It can be clipped later to obtain in batch with the above-mentioned enzyme layer and above-mentioned film layer inside the above-mentioned hole of batch setting and above-mentioned hole
Finished product above-mentioned Continuous Glucose monitor system sensor, without as in the prior art cut after successively by being manually arranged
Enzyme layer and film layer, or using the machine setting enzyme layer and film layer of high precision, production cost is reduced, improve production effect
Rate.
The present invention also provides a kind of Continuous Glucoses to monitor system, and above-mentioned Continuous Glucose monitoring system includes above-mentioned holds
Continuous glucose monitoring system sensor.The production method of Continuous Glucose monitoring system sensor provided by the present invention, passes through
Conductive layer and insulating layer are alternately stacked on matrix by preset order, above-mentioned conductive layer and above-mentioned insulating layer are bio-compatible
Conductive layer and insulating layer made of property material;In predeterminable area aperture, hole is obtained, the inner wall of above-mentioned hole exposes corresponding
Conductive layer, the inner wall of each above-mentioned hole only with a conductive layer contact;Enzyme layer is set in the hole obtained after aperture, on
Enzyme layer is stated for generating electric current with glucose response;Film layer is set in the hole that above-mentioned enzyme layer was set, and above-mentioned film layer is to Portugal
Grape sugar has permeability;Above-mentioned matrix is cut, multiple above-mentioned Continuous Glucose monitoring system sensors are obtained.The present invention exists
The conversion zone of porous is set on conductive layer and insulating layer with biocompatibility, makes above-mentioned Continuous Glucose monitoring system
Sensor before cutting can with inside the above-mentioned hole of batch setting and above-mentioned hole above-mentioned enzyme layer and above-mentioned film layer, after pass through
The above-mentioned Continuous Glucose monitoring system sensor that can obtain finished product in batch is cut, after the cutting as in the prior art
Successively by being manually arranged enzyme layer and film layer, or using the machine setting enzyme layer and film layer of high precision, production cost is reduced,
Improve production efficiency.
Each embodiment in this specification is described in a progressive manner, the highlights of each of the examples are with it is other
The difference of embodiment, same or similar part may refer to each other between each embodiment.For being filled disclosed in embodiment
For setting, since it is corresponded to the methods disclosed in the examples, so being described relatively simple, related place is referring to method part
Explanation.
It should be noted that in the present specification, relational terms such as first and second and the like are used merely to one
A entity or operation with another entity or operate distinguish, without necessarily requiring or implying these entities or operation it
Between there are any actual relationship or orders.Moreover, the terms "include", "comprise" or its any other variant are intended to
Cover non-exclusive inclusion, so that the process, method, article or equipment for including a series of elements not only includes those
Element, but also including other elements that are not explicitly listed, or further include for this process, method, article or setting
Standby intrinsic element.In the absence of more restrictions, the element limited by sentence "including a ...", it is not excluded that
There is also other identical elements in the process, method, article or equipment for including above-mentioned element.
Above to a kind of Continuous Glucose monitoring system sensor provided by the present invention and preparation method thereof, continue grape
Glucose monitor system is described in detail.Specific case used herein explains the principle of the present invention and embodiment
It states, the above description of the embodiment is only used to help understand the method for the present invention and its core ideas.It should be pointed out that for this skill
For the those of ordinary skill in art field, without departing from the principle of the present invention, several change can also be carried out to the present invention
Into and modification, these improvements and modifications also fall within the scope of protection of the claims of the present invention.
Claims (10)
1. a kind of production method of Continuous Glucose monitoring system sensor characterized by comprising
Conductive layer and insulating layer are alternately stacked on matrix by preset order, the conductive layer and the insulating layer are biology
Conductive layer and insulating layer made of compatibility material;
In predeterminable area aperture, hole is obtained, the inner wall of described hole exposes corresponding conductive layer, each described hole
Inner wall only with a conductive layer contact;
Enzyme layer is set in the hole obtained after aperture, and the enzyme layer is used to generate electric current with glucose response;
Film layer is set in the hole that the enzyme layer was set, and the film layer has permeability to glucose;
Described matrix is cut, multiple Continuous Glucose monitoring system sensors are obtained.
2. the production method of Continuous Glucose monitoring system sensor as described in claim 1, which is characterized in that correspondence is each
A conductive layer has multiple described holes.
3. the production method of Continuous Glucose monitoring system sensor as claimed in claim 2, which is characterized in that described in difference
The area of the corresponding hole of conductive layer is identical.
4. the production method of Continuous Glucose monitoring system sensor as described in any one of claims 1 to 3, feature exist
In the enzyme layer and the film layer are obtained by mode for dispensing glue.
5. the production method of Continuous Glucose monitoring system sensor as claimed in claim 4, which is characterized in that the insulation
The range of the thickness of layer is 0.005 millimeter to 0.200 millimeter, including endpoint value.
6. the production method of Continuous Glucose monitoring system sensor as claimed in claim 4, which is characterized in that described hole
For circular hole.
7. the production method of Continuous Glucose monitoring system sensor as claimed in claim 4, which is characterized in that the conduction
Layer can be carbonaceous conductive layer or silver conductive layer or golden conductive layer or platinum conductive layer.
8. the production method of Continuous Glucose monitoring system sensor as claimed in claim 4, which is characterized in that the insulation
Layer can be polyimide insulative layer or Parylene insulating layer or polyurethane insulating layer.
9. a kind of Continuous Glucose monitors system sensor, which is characterized in that the Continuous Glucose monitors system sensor and is
System sensor is monitored by the Continuous Glucose that production method as claimed in any one of claims 1 to 8 obtains.
10. a kind of Continuous Glucose monitors system, which is characterized in that the Continuous Glucose monitoring system includes such as claim
Continuous Glucose described in 9 monitors system sensor.
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Application publication date: 20190517 |