CN111803088B - Test method and device of implantable biological monitoring sensor - Google Patents
Test method and device of implantable biological monitoring sensor Download PDFInfo
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- CN111803088B CN111803088B CN202010710536.8A CN202010710536A CN111803088B CN 111803088 B CN111803088 B CN 111803088B CN 202010710536 A CN202010710536 A CN 202010710536A CN 111803088 B CN111803088 B CN 111803088B
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- 238000012544 monitoring process Methods 0.000 title claims abstract description 58
- 238000010998 test method Methods 0.000 title claims abstract description 8
- 238000012360 testing method Methods 0.000 claims abstract description 97
- 239000000243 solution Substances 0.000 claims description 115
- 239000012085 test solution Substances 0.000 claims description 75
- WCUXLLCKKVVCTQ-UHFFFAOYSA-M Potassium chloride Chemical compound [Cl-].[K+] WCUXLLCKKVVCTQ-UHFFFAOYSA-M 0.000 claims description 30
- 239000000463 material Substances 0.000 claims description 30
- BASFCYQUMIYNBI-UHFFFAOYSA-N platinum Chemical compound [Pt] BASFCYQUMIYNBI-UHFFFAOYSA-N 0.000 claims description 30
- WQZGKKKJIJFFOK-GASJEMHNSA-N Glucose Natural products OC[C@H]1OC(O)[C@H](O)[C@@H](O)[C@@H]1O WQZGKKKJIJFFOK-GASJEMHNSA-N 0.000 claims description 28
- 239000008103 glucose Substances 0.000 claims description 28
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims description 24
- 238000011056 performance test Methods 0.000 claims description 21
- MHAJPDPJQMAIIY-UHFFFAOYSA-N Hydrogen peroxide Chemical compound OO MHAJPDPJQMAIIY-UHFFFAOYSA-N 0.000 claims description 17
- 235000011164 potassium chloride Nutrition 0.000 claims description 15
- 239000001103 potassium chloride Substances 0.000 claims description 15
- 238000002513 implantation Methods 0.000 claims description 12
- 239000007943 implant Substances 0.000 claims description 11
- 230000000694 effects Effects 0.000 claims description 10
- 238000000034 method Methods 0.000 claims description 8
- 239000011521 glass Substances 0.000 claims description 6
- 230000007246 mechanism Effects 0.000 claims description 5
- 238000007493 shaping process Methods 0.000 claims description 3
- 238000001514 detection method Methods 0.000 description 14
- RZVAJINKPMORJF-UHFFFAOYSA-N Acetaminophen Chemical compound CC(=O)NC1=CC=C(O)C=C1 RZVAJINKPMORJF-UHFFFAOYSA-N 0.000 description 8
- CIWBSHSKHKDKBQ-JLAZNSOCSA-N Ascorbic acid Chemical compound OC[C@H](O)[C@H]1OC(=O)C(O)=C1O CIWBSHSKHKDKBQ-JLAZNSOCSA-N 0.000 description 8
- 229960005070 ascorbic acid Drugs 0.000 description 4
- 235000010323 ascorbic acid Nutrition 0.000 description 4
- 239000011668 ascorbic acid Substances 0.000 description 4
- 238000010438 heat treatment Methods 0.000 description 4
- 229960005489 paracetamol Drugs 0.000 description 4
- 230000008569 process Effects 0.000 description 4
- 230000008878 coupling Effects 0.000 description 3
- 238000010168 coupling process Methods 0.000 description 3
- 238000005859 coupling reaction Methods 0.000 description 3
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- 241000270728 Alligator Species 0.000 description 2
- 239000003814 drug Substances 0.000 description 2
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- 239000012530 fluid Substances 0.000 description 2
- CIWBSHSKHKDKBQ-UHFFFAOYSA-N 2-(1,2-dihydroxyethyl)-3,4-dihydroxy-2h-furan-5-one Chemical compound OCC(O)C1OC(=O)C(O)=C1O CIWBSHSKHKDKBQ-UHFFFAOYSA-N 0.000 description 1
- 239000008280 blood Substances 0.000 description 1
- 210000004369 blood Anatomy 0.000 description 1
- 238000007796 conventional method Methods 0.000 description 1
- 238000006056 electrooxidation reaction Methods 0.000 description 1
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/145—Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value ; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid or cerebral tissue
- A61B5/1495—Calibrating or testing of in-vivo probes
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/145—Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value ; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid or cerebral tissue
- A61B5/14503—Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value ; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid or cerebral tissue invasive, e.g. introduced into the body by a catheter or needle or using implanted sensors
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/68—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
- A61B5/6846—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive
- A61B5/6847—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive mounted on an invasive device
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- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N27/00—Investigating or analysing materials by the use of electric, electrochemical, or magnetic means
- G01N27/26—Investigating or analysing materials by the use of electric, electrochemical, or magnetic means by investigating electrochemical variables; by using electrolysis or electrophoresis
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Abstract
The invention relates to a test method and a device of an implanted biological monitoring sensor, which comprises a test device and a sensor combined clamp capable of being clamped on the test device, wherein the test device comprises a support, a test board fixed on the support and an auxiliary tool used for assisting the sensor combined clamp to clamp a combined unit frame, the auxiliary tool comprises a clamp and an auxiliary rapid clamp fixedly arranged on the clamp, and compared with the traditional test device, the test device needs to cut a sensor in the combined unit frame in advance, so that the sensor is cut into individual sensors and the individual sensors need to be clamped and detected one by one.
Description
Technical Field
The invention relates to the technical field of equipment detection, in particular to a testing method and a testing device of an implantable biological monitoring sensor.
Background
The implantable biological monitoring sensor is used for being implanted into the surface of human skin and monitoring the blood sugar parameter of a human body in real time, in order to ensure that the sensor can keep good contact with subcutaneous tissue fluid of the human body after entering the human body when being implanted, performance monitoring is required to be carried out before the implantable biological monitoring sensor enters the market, at present, the implantable biological monitoring sensor is tested, an electrochemical workstation is generally adopted, when the sensor is detected on the electrochemical workstation, the sensor is specifically configured with solution simulating the tissue fluid of the human body, then the sensor is installed on the workstation, an implanted part of the sensor is soaked in the solution, analysis is carried out through data in the test process, but the sensor is limited by the mode of the workstation, only a single sensor after cutting can be installed at each time, the detection efficiency is low, the actual temperature of the human body cannot be completely simulated, and the detection accuracy is poor.
Disclosure of Invention
The invention aims to solve the existing problems, and provides a testing method and a testing device for an implantable biological monitoring sensor.
The technical solution is as follows
The utility model provides a testing arrangement of implanted biological monitoring sensor, but including testing arrangement and joint in the sensor on testing arrangement allies oneself with the clamping, testing arrangement includes the support and is fixed in the testboard on the support, the sensor allies oneself with the clamping including joint piece and quick anchor clamps, the joint piece is including the U template of joint board and perpendicular shaping in joint board one side, but there is the motion connecting block through the sliding connection of guide rail mechanism on the U template.
Preferably, the lower end of the motion connecting block is fixedly connected with a first insulating block, a positive terminal and a negative terminal are penetrated and fixed on the first insulating block, one end of the rapid clamp is fixedly connected on the motion connecting block, the other end of the rapid clamp is fixedly connected on the upper end of the clamping plate, one side of the clamping plate, which is close to the first insulating block, is fixedly provided with a second insulating block which is attached to the first insulating block, the lower surfaces of the first insulating block and the second insulating block are flush with the lower surface of the clamping plate, the clamping plate is provided with a mounting hole, a clamping plate is rotatably arranged in the mounting hole, the distance between the lower surface of the clamping plate and the upper surface of the second insulating block is the height size of an object to be clamped, the object to be clamped is a combined unit frame fixed with a plurality of implanted biological monitoring sensors, and the combined unit frame comprises the implanted biological monitoring sensors, the implantable biological monitoring sensor includes an implant.
Preferably, the device comprises an auxiliary tool for assisting the sensor assembling clamp to clamp the assembling unit frame, the auxiliary tool comprises a clamp and an auxiliary rapid clamp fixedly arranged on the clamp, the clamp comprises a base and a placing block formed on the base, the base is provided with a first placing groove for placing the clamping block, one side of the base, which is positioned on the first placing groove, is provided with a U-shaped limiting groove, the U-shaped limiting groove is matched with the buckling plate of the clamping block, the upper surface of the placing block is provided with a second placing groove matched with the shape and the size of the combined unit frame, the height between the second placing groove and the base is H1, the height of the clamping plate is H2, the height of the second insulating block is H3, and the sum of the height H2 of the clamping plate and the height H3 of the second insulating block is equal to the height H1 between the second placing groove and the base.
Preferably, a first clamping limiting plate and a second clamping limiting plate are formed on two sides of the test board respectively, clamping limiting groove groups matched with the size and the shape of the clamping plates are symmetrically formed in the first clamping limiting plate and the second clamping limiting plate, five rows or more than five rows of solution unit grooves are formed in the upper surface of the test board, the clamping limiting grooves are formed in the solution unit grooves formed by a plurality of solution groove holes, and the depth of each solution groove hole is higher than the height of the implanted portion.
Preferably, a constant-temperature water bath device is arranged in the test bench.
A test method of an implantable biological monitoring sensor comprises the following steps:
s1: preparing a combined unit frame, wherein the combined unit frame comprises a flexible base material and a glass frame surrounding the outer side of the flexible base material, implanted biological monitoring sensor units are arranged on the flexible base material in parallel, each implanted biological monitoring sensor unit comprises an electrode part and an implanted part formed at the lower end of the electrode part, the electrode part is connected with the flexible base material, and the rest parts are separated from the flexible base material;
s2: fixing and clamping, namely limiting and clamping the combined unit frame prepared in the step S1 on the sensor combined clamp through an auxiliary clamp, and turning over the combined unit frame to expose the implantation part;
s3: preparing a performance test solution, and preparing the performance test solution;
s4: and (4) performance testing, namely placing the implant part into the performance testing solution in the step S3, standing, and recording current data.
Preferably, the performance test solution in the step S3 may be a glucose solution, the performance test in the step S4 may be an activity test, and the activity test solution may be one glucose solution or more than one glucose solution with different concentrations.
Preferably, the performance test solution in step S3 may be an anti-interference test solution, the performance test in step S4 may be an anti-interference test, and the anti-interference test solution may be an anti-interference solution prepared from an interference solution and a 0mM base solution.
Preferably, the performance test solution in step S3 may be a reference potential test solution, the performance test in step S4 may be a reference potential test, and the reference potential test solution may be a potassium chloride reference potential test solution.
Preferably, the performance test solution in the step S3 may be a platinum black test solution, the performance test in the step S4 may be a platinum black test solution, and the platinum black test solution may be a platinum black test solution prepared by mixing a hydrogen peroxide solution and a 0mM base solution.
The invention has the advantages of
1. According to the test device for the implantable biological monitoring sensor, when the combined unit frame is clamped by the sensor combined clamp, compared with the traditional test device, the sensor in the combined unit frame needs to be cut in advance, so that the sensor is cut into individual sensors, and the individual sensors need to be clamped and detected one by one.
2. According to the test device of the implantable biological monitoring sensor, five or more rows of solution unit grooves are formed in the test board, each solution unit groove is formed by forming a plurality of solution groove holes, test solutions with different performances can be placed in the test groove holes, the detection range is wider, the test solutions with different concentrations of the active test solutions can test the response gradient of the sensor, and recorded data obtained after the implanted part is soaked in the solution for five to six minutes are data under a stable state, so that the accuracy is higher, and the scientificity is better.
3. According to the testing device of the implantable biological monitoring sensor, the constant-temperature water bath device is arranged at the bottom of the testing device, the constant temperature of the solution is kept within the range of 32 +/-1 ℃, the constant temperature ensures that the temperature of the solution is close to the actual temperature of a human body, the temperature condition consistency in the testing process is controlled, and the accuracy and the scientificity of testing data are improved.
Drawings
FIG. 1 is a diagram of an implantable bio-monitoring sensor testing device in accordance with the present invention;
FIG. 2 is a schematic structural view of a sensor assembly clamp according to the present invention;
FIG. 3 is a schematic structural view of an auxiliary tool according to the present invention;
FIG. 4 is a front view of the clip assembly of the present invention;
FIG. 5 is a schematic view of a sensor attachment clamp of the present invention;
FIG. 6 is a schematic structural diagram of a testing apparatus according to the present invention;
FIG. 7 is a schematic view of the thermostatic waterbath apparatus of the present invention;
FIG. 8 is a schematic diagram of a unit segmentation trace according to the present invention;
FIG. 9 is a partial enlarged view of a unit frame according to the present invention;
fig. 10 is a schematic view of a frame of the sensor alligator clamp alligator unit of the present invention.
In the figure: testing arrangement 1, sensor allies oneself with clamping 2, joint piece 21, quick fixture 22, joint board 211, mounting hole 2111, U type board 212, buckle 213, testboard 3, solution unit groove 31, solution slotted hole 32, guide rail mechanism 4, motion connecting block 5, first insulating block 6, positive and negative terminal 7, second insulating block 8, allies oneself with dress unit frame 9, second standing groove 91, auxiliary fixtures 10, clamping 11, supplementary quick fixture 101, base 111, first standing groove 1111, place piece 112, U type spacing groove 12, thermostatic waterbath device 13, delivery port 131, water inlet 132, plant portion 14, the spacing groove group of joint 15, the aqua storage tank 16.
Detailed Description
The technical solutions in the embodiments of the present invention will be clearly and completely described below with reference to the drawings in the embodiments of the present invention, and it is obvious that the described embodiments are only a part of the embodiments of the present invention, and not all of the embodiments.
In the description of the present invention, it is to be understood that the terms "upper", "lower", "inside", "inner", "etc. indicate orientations or positional relationships based on those shown in the drawings, and are only for convenience in describing the present invention and simplifying the description, but do not indicate or imply that the referred device or element must have a specific orientation, be constructed in a specific orientation, and be operated, and thus, should not be construed as limiting the present invention.
In the present invention, unless otherwise expressly specified or limited, the terms "disposed," "mounted," "connected," and "fixed" are to be construed broadly and may, for example, be fixedly connected or detachably connected; may be a mechanical connection; may be directly connected or indirectly connected through an intermediate. The specific meanings of the above terms in the present invention can be understood by those skilled in the art according to specific situations.
As shown in fig. 1-10, the testing device for the implantable biological monitoring sensor of the invention comprises a testing device 1 and a sensor coupling clamp 2 which can be clamped on the testing device 1, so as to facilitate the clamping detection of the implantable biological monitoring sensor in the later period, wherein the testing device 1 comprises a bracket and a testing platform 3 fixed on the bracket, the testing platform 3 is used for placing relevant testing solution in the later period, the sensor coupling clamp 2 comprises a clamping block 21 and a quick clamp 22, the clamping block 21 comprises a clamping plate 211 and a U-shaped plate 212 vertically formed on one side of the clamping plate 211, a motion connecting block 5 is slidably connected on the U-shaped plate 212 through a guide rail mechanism 4 so as to facilitate the clamping of the sensor coupling clamp 2, a first insulating block 6 is fixedly connected at the lower end of the motion connecting block 5, so as to avoid the whole device generating current when the power is switched on, the positive and negative terminals 7 penetrate through and are fixed on the first insulating block 6, so that the current passing through the positive and negative terminals 7 is only transmitted to the sensor, one end of the rapid clamp 22 is fixedly connected to the motion connecting block 5, the other end of the rapid clamp is fixedly connected to the upper end of the clamping plate 211, one side of the clamping plate 211 close to the first insulating block 6 is fixedly provided with a second insulating block 8, the clamping plate 211 is provided with a mounting hole 2111, a buckle plate 213 is rotatably mounted in the mounting hole 2111, the part of the buckle plate 213 exposed on the clamping plate 211 is fixed by a fixing block fixedly mounted on the side edge of the clamping plate 211, the distance between the lower surface of the buckle plate 213 and the upper surface of the second insulating block 8 is the height dimension of an object to be clamped, so that the combined unit frame 9 can be just limited and clamped between the buckle plate 213 and the second insulating block 8, and the object to be clamped is the combined unit frame 9 fixed with a plurality of implanted biological monitoring sensors, the two sides of the implanted biological monitoring sensor of the combined unit frame 9 and the edge of the implanted part 14 are divided, and the dividing track is shown as a dividing line A in figure 8, so that compared with the traditional testing device 1, the top end of the implanted biological monitoring sensor is connected with the combined unit frame 9, the sensor in the combined unit frame needs to be cut in advance, the sensor is cut into independent sensors, and the sensors need to be clamped and detected one by one.
Specifically, the testing device 1 of the implantable biological monitoring sensor comprises an auxiliary tool 10 for clamping a combined unit frame 9 by an auxiliary sensor combined clamp 2, wherein the auxiliary tool 10 comprises a clamp 11 and an auxiliary rapid clamp 101 fixedly mounted on the clamp 11, the clamp 11 comprises a base 111 and a placing block 112 formed on the base 111, a first placing groove 1111 for placing a clamping block 21 is formed on the base 111, a U-shaped limiting groove 12 is formed on one side of the base 111 positioned on the first placing groove 1111, the U-shaped limiting groove 12 is matched with a buckling plate 213 of the clamping block 21, a second placing groove 91 matched with the combined unit frame 9 in shape and size is formed on the upper surface of the placing block 112, the height between the second placing groove 91 and the base 111 is H1, the height of the clamping plate 211 is H2, and the height of the second insulating block 8 is H3, the sum of the height H2 of the chucking plate 211 and the height H3 of the second insulating block 8 is equal to the height H1 between the second placement groove 91 and the base 111, the height of the auxiliary tool 10 is consistent with that of the position of the sensor combined clamp 2 for placing the combined unit frame 9, the phenomenon that the combined unit frame 9 is crushed due to extrusion caused by different heights during clamping is avoided, influences the integrity of the sensor in the united unit frame 9, one end of the united unit frame 9 close to the implantation part 14 is placed on the second placing groove 91 of the auxiliary tool 10 and clamps the united unit frame 9 through the auxiliary rapid clamp 101, when the united unit frame 9 is clamped between the buckle plate 213 of the sensor united clamp 2 and the second insulating block 8, the rapid clamp 22 clamps the top end of the united unit frame 9, meanwhile, the auxiliary quick clamp 101 is released, the multi-unit frame 9 is rotated downwards, and the clamping is carried out through the pinch plate 213, so that the implantation part 14 is completely exposed outside along the splitting track.
Specifically, the bottom of the auxiliary sensor assembling clamp 2 is placed on the second placing groove 91 during clamping, and the buckling plate 213 of the auxiliary sensor assembling clamp 2 is partially placed in the U-shaped limiting groove 12, so that the matching is tighter.
Specifically, the guide rail mechanism 4 may be a micro linear guide rail, which is a conventional technique in the art and therefore will not be described in detail.
Specifically, 3 both sides of testboard are the shaping respectively and are had first joint limiting plate and second joint limiting plate, first joint limiting plate with the second joint limiting plate on the symmetry seted up with the spacing bank of cells of joint 15 of the big small shape matched with of joint board 211, the solution unit cell 31 more than five rows or five rows has been seted up to 3 upper surfaces of testboard, solution unit cell 31 comprises a plurality of solution slotted hole 32, the solution slotted hole 32 degree of depth is higher than implant 14 heights for implant 14 can soak completely in solution slotted hole 32, guarantee the testing result accuracy.
Specifically, the thermostatic waterbath device 13 is installed at the bottom of the test bench 3, the thermostatic waterbath device 13 includes a water storage tank 16 installed inside the test bench 3, a water outlet 131 and a water inlet 132 installed at both sides of the water storage tank 16, a water pump and a thermostatic heating device, the position of the water inlet 132 is lower than the position of the water outlet 131, the water pump makes the warm water in the thermostatic heating device enter the water storage tank 16 from the water inlet 132 through a communicated water pipe, and then the warm water in the water storage tank 16 is connected into the thermostatic heating device through the water pipe by the water outlet 131 for heating and circulating, so that the required temperature is maintained in the whole detection process, and the stability of the detection data is maintained, the thermostatic waterbath device 13 is a conventional technology in the field, and therefore, redundant description is omitted.
The specific operation process is as follows:
placing one end of the combined unit frame 9 close to the implantation part 14 on a second placing groove 91 of an auxiliary tool 10, buckling the sensor combined clamp 2 by an auxiliary rapid clamp 101, clamping the other end of the combined unit frame 9 between a first insulating block 6 and a second insulating block 8 of the sensor combined clamp 2, placing a clamping block 21 of the sensor combined clamp 2 at the second placing groove 91 of the auxiliary tool 10, just clamping a buckling plate 213 of the sensor combined clamp 2 at a U-shaped limiting groove 12 of the auxiliary tool 10, buckling the combined unit frame 9 by a rapid clamp 22 of the sensor combined clamp 2 at the same time, opening the auxiliary rapid clamp 101, taking the sensor combined clamp 2 buckled with the combined unit frame 9 out of the auxiliary tool 10, overturning the combined unit frame 9 for a certain angle, and clamping one side of the combined unit frame 9 by the buckling plate 213 when the implantation part 14 is completely exposed along a dividing track, the sensor combined clamp 2 provided with the combined unit frame 9 is clamped on the clamping limiting groove group 15, the implanting part 14 is just completely soaked in a required testing solution at the moment, testing is carried out, testing data are recorded, the sensor combined clamp 2 is taken out and sequentially placed into different testing solutions, testing is carried out according to a testing method, and the testing data are recorded for analysis.
Specifically, the performance test may be an activity test, an anti-interference test, a reference potential test, and a platinum black test, and each test embodiment is as follows:
specific example 1:
the invention discloses an activity test method of an implantable biological monitoring sensor, which comprises the following steps:
s1: preparing a combined unit frame 9, wherein the combined unit frame 9 comprises a flexible base material and a glass frame surrounding the outer side of the flexible base material, implanted biological monitoring sensor units are arranged on the flexible base material in parallel, each implanted biological monitoring sensor unit comprises an electrode part and an implanted part 14 formed at the lower end of the electrode part, the electrode part is connected with the flexible base material, and the rest parts are separated from the flexible base material;
s2: fixing and clamping, namely clamping the combined unit frame 9 on the sensor combined clamp 2 through an auxiliary tool 10, turning the combined unit frame 9 to completely expose the implantation part 14 of the biological monitoring sensor, and then rotating a buckle plate 213 on the sensor combined clamp 2 to buckle the combined unit frame 9;
s3: preparing an activity test solution, preferably selecting a glucose solution with the concentration of 0-3 mn, 2-8 mn, 12-18 mn and 28-33 mn (millimole), sequentially putting the glucose solution with the concentration of 0-3 mn (millimole), the glucose solution with the concentration of 2-8 mn (millimole), the glucose solution with the concentration of 12-18 mn (millimole) and the glucose solution with the concentration of 28-33 mn (millimole) into different solution unit tanks, starting a constant-temperature water bath device 13, and maintaining the temperature range of the test solution at 32 +/-1 ℃;
s4: the test was performed by placing the sensor assembly holder 2 having the assembly unit frame fixed thereto in step S1 in a position corresponding to the solution unit tank in which the 0 to 3mn (millimole) glucose solution was placed, and the current data was recorded after the implant part 14 was immersed in the 0 to 3mn (millimole) glucose solution and allowed to stand for 5 to 6 minutes.
And S5, placing the sensor assembly clamp 2 in a 2-8 mn (millimole) glucose solution for testing, taking out the sensor assembly clamp 2 subjected to the detection of the 0-3 mn (millimole) glucose solution in the step S3, clamping the sensor assembly clamp at a position corresponding to a solution unit tank in which the 2-8 mn (millimole) glucose solution is placed, immersing the implant part 14 in the 2-8 mn (millimole) glucose solution, and standing for 5-6 minutes to record current data.
And S6, placing the sensor assembly clamp 2 in a 12-18 mn (millimole) glucose solution for testing, taking out the sensor assembly clamp 2 subjected to the detection of the 2-8 mn (millimole) glucose solution in the step S4, clamping the sensor assembly clamp at a position corresponding to a solution unit tank in which the 12-18 mn (millimole) glucose solution is placed, immersing the implant part 14 in the 12-18 mn (millimole) glucose solution, and standing for 5-6 minutes to record current data.
And S7, placing the sensor assembly clamp 2 in a 28-33 mn (millimole) glucose solution for testing, taking out the sensor assembly clamp 2 subjected to the detection of the 12-18 mn (millimole) glucose solution in the step S5, clamping the sensor assembly clamp at a position corresponding to a solution unit tank in which the 28-33 mn (millimole) glucose solution is placed, immersing the implant part 14 in the 28-33 mn (millimole) glucose solution, and standing for 5-6 minutes to record current data.
And S8, placing the sensor assembly clamp 2 in a 28-33 mn (millimole) glucose solution for testing, taking out the sensor assembly clamp 2 subjected to the detection of the 12-18 mn (millimole) glucose solution in the step S5, clamping the sensor assembly clamp at a position corresponding to a solution unit tank in which the 28-33 mn (millimole) glucose solution is placed, immersing the implant part 14 in the 28-33 mn (millimole) glucose solution, and standing for 5-6 minutes to record current data.
Specific example 2:
the invention discloses an anti-interference test method of an implantable biological monitoring sensor, which comprises the following steps:
s1: preparing a combined unit frame 9, wherein the combined unit frame 9 comprises a flexible base material and a glass frame surrounding the outer side of the flexible base material, implanted biological monitoring sensor units are arranged on the flexible base material in parallel, each implanted biological monitoring sensor unit comprises an electrode part and an implanted part 14 formed at the lower end of the electrode part, the electrode part is connected with the flexible base material, and the rest parts are separated from the flexible base material;
s2: fixing and clamping, namely clamping the combined unit frame 9 on the sensor combined clamp 2 through an auxiliary tool 10, turning the combined unit frame 9 to completely expose the implantation part 14 of the biological monitoring sensor, and then rotating a buckle plate 213 on the sensor combined clamp 2 to buckle the combined unit frame 9;
s3: preparing an anti-interference test solution, wherein the anti-interference test solution is preferably an anti-interference solution prepared from 3mg/dL ascorbic acid and 0mM base solution or an anti-interference solution prepared from 20mg/dL acetaminophen and 0mM base solution, sequentially putting the anti-interference solution into different solution unit tanks, starting a constant temperature water bath device 13, and maintaining the temperature range of the test solution at 32 +/-1 ℃;
s4: and (3) placing the test piece in an anti-interference solution prepared from ascorbic acid and 0mM base solution at 3mg/dL for testing, clamping the sensor combined clamp 2 fixed with a combined unit frame in the step S1 at a position corresponding to a solution unit tank in which the anti-interference solution prepared from the ascorbic acid and the 0mM base solution at 3mg/dL is placed, completely immersing the implantation part 14 in the anti-interference solution prepared from the ascorbic acid and the 0mM base solution at 3mg/dL, and recording current data after standing for 5-6 minutes.
S5, placing the test piece in an anti-interference solution prepared from 20mg/dL of acetaminophen and 0mM base solution for testing, taking out the sensor combined clamp 2 subjected to detection by 3mg/dL of ascorbic acid and the anti-interference solution prepared from 0mM base solution in the step S3, clamping the sensor combined clamp at a position corresponding to a unit tank for placing the anti-interference solution prepared from 20mg/dL of acetaminophen and 0mM base solution, immersing the implanted part 14 in the anti-interference solution prepared from 20mg/dL of acetaminophen and 0mM base solution, and recording current data after standing for 5-6 minutes.
Specific example 3:
the invention discloses a reference potential testing method of an implanted biological monitoring sensor, which comprises the following steps:
s1: preparing a combined unit frame 9, wherein the combined unit frame 9 comprises a flexible base material and a glass frame surrounding the outer side of the flexible base material, implanted biological monitoring sensor units are arranged on the flexible base material in parallel, each implanted biological monitoring sensor unit comprises an electrode part and an implanted part 14 formed at the lower end of the electrode part, the electrode part is connected with the flexible base material, and the rest parts are separated from the flexible base material;
s2: fixing and clamping, namely clamping the combined unit frame 9 on the sensor combined clamp 2 through an auxiliary tool 10, turning the combined unit frame 9 to completely expose the implantation part 14 of the biological monitoring sensor, and then rotating a buckle plate 213 on the sensor combined clamp 2 to buckle the combined unit frame 9;
s3: preparing a reference potential test solution, wherein the reference potential test solution is preferably a 0.05mol/L potassium chloride reference potential test solution, a 0.15mol/L potassium chloride reference potential test solution and a 0.3mol/L potassium chloride reference potential test solution, sequentially putting the reference potential test solution, the potassium chloride reference potential test solution and the 0.3mol/L potassium chloride reference potential test solution into different solution unit tanks, starting a constant-temperature water bath device 13, and maintaining the temperature range of the test solution to be 32 +/-1 ℃;
s4: and (3) placing the test piece in a potassium chloride reference potential test solution of 0.05mol/L for testing, clamping the sensor combined clamp 2 fixed with the combined unit frame in the step S1 at a position corresponding to the solution unit tank in which the potassium chloride reference potential test solution of 0.05mol/L is placed, completely immersing the implanted part 14 in the potassium chloride reference potential test solution of 0.05mol/L, and recording current data after standing for 5-6 minutes.
And S5, placing the test piece in 0.3mol/L potassium chloride reference potential test solution for testing, taking out the sensor combined clamp 2 subjected to the test of the 0.05mol/L potassium chloride reference potential test solution in the step S3, clamping the sensor combined clamp at a position corresponding to a unit tank for placing the 0.3mol/L potassium chloride reference potential test solution, immersing the implanted part 14 in the 0.3mol/L potassium chloride reference potential test solution, and recording current data after standing for 5-6 minutes.
Specific example 4:
the invention discloses a platinum black testing method of an implantable biological monitoring sensor, which comprises the following steps:
s1: preparing a combined unit frame 9, wherein the combined unit frame 9 comprises a flexible base material and a glass frame surrounding the outer side of the flexible base material, implanted biological monitoring sensor units are arranged on the flexible base material in parallel, each implanted biological monitoring sensor unit comprises an electrode part and an implanted part 14 formed at the lower end of the electrode part, the electrode part is connected with the flexible base material, and the rest parts are separated from the flexible base material;
s2: fixing and clamping, namely clamping the combined unit frame 9 on the sensor combined clamp 2 through an auxiliary tool 10, turning the combined unit frame 9 to completely expose the implantation part 14 of the biological monitoring sensor, and then rotating a buckle plate 213 on the sensor combined clamp 2 to buckle the combined unit frame 9;
s3: preparing a platinum black test solution, wherein the platinum black test solution is preferably a platinum black test solution prepared from a 50 mu mol/L hydrogen peroxide solution and a 0mM base solution, a platinum black test solution prepared from a 100 mu mol/L hydrogen peroxide solution and a 0mM base solution, and a platinum black test solution prepared from a 150 mu mol/L hydrogen peroxide solution and a 0mM base solution, sequentially putting the platinum black test solutions into different solution unit tanks, and starting a constant temperature water bath device 13 to maintain the temperature range of the test solution at 32 +/-1 ℃;
s4: the test piece was placed in a platinum black test solution prepared from a hydrogen peroxide solution of 50. mu. mol/L and a base solution of 0mM, and the sensor assembly jig 2 having the assembly unit frame fixed thereto in step S1 was attached to a position corresponding to the solution unit tank in which the platinum black test solution prepared from a hydrogen peroxide solution of 50. mu. mol/L and a base solution of 0mM was placed, so that the implanted portion 14 was completely immersed in the platinum black test solution prepared from a hydrogen peroxide solution of 50. mu. mol/L and a base solution of 0mM, and the current data was recorded after leaving to stand for 5 to 6 minutes.
S5, placing the sensor assembly clamp 2 in a platinum black test solution prepared from 100 mu mol/L hydrogen peroxide solution and 0mM base solution for testing, taking out and clamping the sensor assembly clamp 2 in a position corresponding to the solution unit tank in which the 100 mu mol/L hydrogen peroxide solution and the 0mM base solution prepared platinum black test solution are placed in the step S3, immersing the implant part 14 in the 100 mu mol/L hydrogen peroxide solution and the 0mM base solution prepared platinum black test solution, and recording current data after standing for 5-6 minutes.
S6, placing the test piece in a platinum black test solution prepared from a hydrogen peroxide solution of 150 mu mol/L and a base solution of 0mM for testing, taking out the sensor combination clamp 2 subjected to the detection of the hydrogen peroxide solution of 100 mu mol/L and the platinum black test solution prepared from the base solution of 0mM in the step S3, clamping the sensor combination clamp at a position corresponding to a solution unit tank in which the hydrogen peroxide solution of 150 mu mol/L and the platinum black test solution prepared from the base solution of 0mM are placed, immersing the implanted part 14 in the platinum black test solution prepared from the hydrogen peroxide solution of 150 mu mol/L and the base solution of 0mM, and recording current data after standing for 5-6 minutes.
Specifically, the activity test in example 1 is used to simulate the activity state of the implanted biological monitoring sensor under normal conditions in a human body, the anti-interference test in example 2 is used to analyze the anti-interference capability of the implanted biological monitoring sensor by simulating the data output by the implanted biological monitoring sensor when the human body takes in drugs (VC, cold drugs, etc.), the specific potential test in example 3 is used to simulate the micro-current of the human body through potassium chloride solutions with different concentrations to test the output data of the implanted biological sensor and analyze the output data, the platinum black test in example 4 is used to perform electrochemical oxidation detection on the platinum black layer plated on the implanted part 14 through a platinum black test solution prepared from hydrogen peroxide with different concentrations and 0mM base solution, and the conductivity of the platinum black layer is analyzed through data.
Specifically, the concentrations of the 0mM base solutions in examples 2 and 4 are shown in the following table:
finally, it should be noted that: although the present invention has been described in detail with reference to the foregoing embodiments, it will be apparent to those skilled in the art that modifications may be made to the embodiments or portions thereof without departing from the spirit and scope of the invention.
Claims (8)
1. A testing device for an implantable biological monitoring sensor, comprising: the device comprises a testing device (1) and a sensor connecting clamp (2) which can be connected to the testing device (1) in a clamping manner, wherein the testing device (1) comprises a support and a testing table (3) fixed on the support, the sensor connecting clamp (2) comprises a clamping block (21) and a quick clamp (22), the clamping block (21) comprises a clamping plate (211) and a U-shaped plate (212) vertically formed on one side of the clamping plate (211), the U-shaped plate (212) is slidably connected with a motion connecting block (5) through a guide rail mechanism (4), the lower end of the motion connecting block (5) is fixedly connected with a first insulating block (6), a positive terminal and a negative terminal (7) are penetrated through and fixed on the first insulating block (6), one end of the quick clamp (22) is fixedly connected to the motion connecting block (5), and the other end of the quick clamp is fixedly connected to the upper end of the clamping plate (211), clamping plate (211) be close to one side fixed mounting of first insulating block (6) have with second insulating block (8) that first insulating block (6) laminated mutually, first insulating block (6) lower surface, second insulating block (8) lower surface flush with clamping plate (211) lower surface, mounting hole (2111) have been seted up on clamping plate (211), rotatable mounting has buckle (213) in mounting hole (2111), buckle (213) lower surface with interval between second insulating block (8) upper surface is the height dimension of centre gripping object, and centre gripping object is for being fixed with antithetical couplet dress unit frame (9) of a plurality of implanted biological monitoring sensors, antithetical couplet dress unit frame (9) is including implanted biological monitoring sensor, implanted biological monitoring sensor is including implanting portion (14), and this testing arrangement still includes auxiliary fixtures (10) that are used for auxiliary sensors antithetical couplet dress unit frame (9) to be cliied to clamping (2) The auxiliary tool (10) comprises a clamping (11) and an auxiliary quick clamp (101) fixedly mounted on the clamping, wherein the clamping (11) comprises a base (111) and a placing block (112) formed on the base (111), a first placing groove (1111) for placing a clamping block (21) is formed in the base (111), a U-shaped limiting groove (12) is formed in one side of the first placing groove (1111), the U-shaped limiting groove (12) is matched with a buckling plate (213) of the clamping block (21), a second placing groove (91) matched with the shape and size of the combined unit frame (9) is formed in the upper surface of the placing block (112), the height between the second placing groove (91) and the base (111) is H1, the height of the clamping plate (211) is H2, and the height of the second insulating block (8) is H3, the sum of the height H2 of the clamping plate (211) and the height H3 of the second insulating block (8) is equal to the height H1 between the second placing groove (91) and the base (111).
2. The device of claim 1, wherein the implantable bio-monitoring sensor comprises: testboard (3) both sides shaping respectively have first joint limiting plate and second joint limiting plate, first joint limiting plate with the second joint limiting plate on the symmetry seted up with the spacing bank of cells of joint board size shape matched with joint (15), testboard (3) upper surface has been seted up five or solution unit groove (31) more than five rows, joint limiting groove (15) solution unit groove (31) comprise a plurality of solution slotted hole (32), solution slotted hole (32) degree of depth is higher than implantation portion (14) height.
3. The device of claim 1, wherein the implantable bio-monitoring sensor comprises: and a constant-temperature water bath device (13) is arranged at the bottom of the test bench (3).
4. A method of testing using the device of claim 1, wherein the device comprises: the test method comprises the following steps:
s1: preparing a combined unit frame (9), wherein the combined unit frame (9) comprises a flexible base material and a glass frame surrounding the outer side of the flexible base material, implanted biological monitoring sensor units are arranged on the flexible base material in parallel, each implanted biological monitoring sensor unit comprises an electrode part and an implanted part (14) formed at the lower end of the electrode part, the electrode part is connected with the flexible base material, and the rest parts are separated from the flexible base material;
s2: fixing and clamping, namely limiting and clamping the combined unit frame (9) prepared in the step S1 on the sensor combined clamp (2) through an auxiliary clamp, and turning over the combined unit frame (9) to expose the implantation part (14);
s3: preparing a performance test solution, and preparing the performance test solution;
s4: and (4) performance testing, namely placing the implant part (14) into the performance testing solution in the step S3, standing, and recording current data.
5. The method of claim 4, wherein the implantable bio-monitoring sensor is selected from the group consisting of: the performance test solution in the step S3 may be an activity test solution, the performance test in the step S4 is an activity test, and the activity test solution may be one glucose solution or more than one glucose solution with different concentrations.
6. The method of claim 4, wherein the implantable bio-monitoring sensor is selected from the group consisting of: the performance test solution in the step S3 may be an anti-interference test solution, the performance test in the step S4 may be an anti-interference test, and the anti-interference test solution may be an anti-interference solution prepared from an interference solution and a 0mM base solution.
7. The method of claim 4, wherein the implantable bio-monitoring sensor is selected from the group consisting of: the performance test solution in step S3 may be a reference potential test solution, the performance test in step S4 may be a reference potential test, and the reference potential test solution may be a potassium chloride reference potential test solution.
8. The method of claim 4, wherein the implantable bio-monitoring sensor is selected from the group consisting of: the performance test solution in the step S3 may be a platinum black test solution, the performance test in the step S4 may be a platinum black test solution, and the platinum black test solution may be a platinum black test solution prepared by mixing a hydrogen peroxide solution and a 0mM base solution.
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| US20080081958A1 (en) * | 2006-09-28 | 2008-04-03 | Medtronic, Inc. | Implantable medical device with sensor self-test feature |
| CN103995139B (en) * | 2014-05-30 | 2015-10-28 | 浙江大学 | The external performance evaluating system of continuous blood sugar monitoring sensor |
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