WO2018072735A1 - Frd上皮组织染色涂敷器用颜色辅助判读装置及定标液 - Google Patents

Frd上皮组织染色涂敷器用颜色辅助判读装置及定标液 Download PDF

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Publication number
WO2018072735A1
WO2018072735A1 PCT/CN2017/106901 CN2017106901W WO2018072735A1 WO 2018072735 A1 WO2018072735 A1 WO 2018072735A1 CN 2017106901 W CN2017106901 W CN 2017106901W WO 2018072735 A1 WO2018072735 A1 WO 2018072735A1
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Prior art keywords
color
frd
calibrator
applicator
vertical
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PCT/CN2017/106901
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English (en)
French (fr)
Inventor
闫文广
朱波
车晓梦
雷红梅
萧琛
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陕西高源体外诊断试剂有限公司
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Publication of WO2018072735A1 publication Critical patent/WO2018072735A1/zh

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    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01J—MEASUREMENT OF INTENSITY, VELOCITY, SPECTRAL CONTENT, POLARISATION, PHASE OR PULSE CHARACTERISTICS OF INFRARED, VISIBLE OR ULTRAVIOLET LIGHT; COLORIMETRY; RADIATION PYROMETRY
    • G01J3/00—Spectrometry; Spectrophotometry; Monochromators; Measuring colours
    • G01J3/46—Measurement of colour; Colour measuring devices, e.g. colorimeters
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N21/00—Investigating or analysing materials by the use of optical means, i.e. using sub-millimetre waves, infrared, visible or ultraviolet light
    • G01N21/75—Systems in which material is subjected to a chemical reaction, the progress or the result of the reaction being investigated
    • G01N21/77—Systems in which material is subjected to a chemical reaction, the progress or the result of the reaction being investigated by observing the effect on a chemical indicator
    • G01N21/78—Systems in which material is subjected to a chemical reaction, the progress or the result of the reaction being investigated by observing the effect on a chemical indicator producing a change of colour
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/53—Immunoassay; Biospecific binding assay; Materials therefor
    • G01N33/574—Immunoassay; Biospecific binding assay; Materials therefor for cancer
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N35/00—Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor

Definitions

  • the invention patent belongs to the technical field of biomedical detection, and particularly relates to a color assisted interpretation device for FRD epithelial tissue dyeing applicator, a calibration liquid and a method for using the same.
  • the FRD epithelial tissue staining solution is composed of folic acid derivatives, reduced methylene blue, acetic acid, etc., and is brown.
  • the detection mechanism is mainly: high expression of folate receptor on the surface of tumor cells compared with normal cells [1, 2], increased reactive oxygen species, increased demand for iron by tumor cells, and high affinity for methylene blue.
  • the folic acid derivative binds to the folate receptor, and the folic acid derivative together with methylene blue is endocytosed into the cell; under the Fe 2+ catalysis, the reduced state Methylene blue is oxidized by intracellular reactive oxygen species to oxidized methylene blue, from colorless to blue; due to the entry of these macromolecules, the intracellular osmotic pressure is increased, causing the oxidized methylene blue to escape from the cell. Therefore, the color displayed on the medical polyurethane foam or the cotton swab can be directly observed, and whether the cervical epithelium has abnormal lesions is judged [3].
  • a cervical taper applicator for use with the aforementioned staining solution can also be used for diagnosis.
  • a non-limiting example of a cervical taper applicator for use with a color assisted interpretation device of the FRD epithelial tissue stain applicator of the present invention may be the structure illustrated in Figures 3 through 13, the cervical taper applicator having a conical medical bubble made of a foam or foam fiber blend a cotton head and a structure of a handle bar member erected on a conical medical foam head, wherein the tapered medical foam head has a hollow tapered foam head (301) with an enlarged circular disk.
  • a fiber core seeker (303) is mounted in the hollow tapered foam head;
  • the handle bar member includes a sleeve barrel (302) and one sleeve is mounted on the sleeve barrel (302) a push rod (304) and a push ring seat (306) on the lower portion of the sleeve (302), and a spring connected between the bottom end of the push rod (304) and the upper end of the fiber core seeker (303) (308), an L-shaped through groove (304a) is opened in the middle of the lower portion of the push rod (304), and a vertical and an L-shaped through groove (304a) are vertically formed on the two side walls of the sleeve (302).
  • the vertical strip passage groove (302a) aligned with the groove is symmetrically opened with a pin hole (306a) on both side walls of the push ring seat (306), and the L-shaped through groove (304a) and the vertical strip through groove ( A pin (309) is inserted between the 302a) and the pin hole (306a), and four fulcrums (305) vertically downward in the direction of the handle are symmetrically connected to the outer circumference of the push ring seat (306).
  • a gear (307) which is rotatable by means of a gear on the plunger shaft 21 of the color assisted interpretation device of the present invention.
  • the angle between the transverse groove length of the L-shaped through groove opened in the lower part of the push rod (304) and the axis of the push rod (304) is 30°, and when the cervical taper applicator is in the non-coating working state, from the outside to the inside A pin (309) that passes through the pin hole (306a) and the vertical groove (302a) in sequence is inserted into the transverse groove of the pin hole (306a).
  • a non-limiting example of a cervical taper applicator that can be used with the color assisted interpretation device of the FRD epithelial tissue dyeing applicator in the present invention may also be that the cervical taper applicator provided has a foam or foam.
  • a tapered medical foam head made of a cotton fiber hybrid material and a pair of handle bars attached vertically to the tapered medical foam head, wherein: the tapered medical foam head has an enlarged circular disk Hollow-conical foam head, which is provided with a rivet-shaped fiber core seeker movable up and down in the hollow conical foam head;
  • the handle bar member comprises a sleeve cylinder and a wearing sleeve a push rod in the barrel and a push ring seat on the lower part of the sleeve tube, a spring is connected between the bottom end of the push rod and the upper end of the fiber core seeker, and an L-shaped through groove is opened in the middle of the lower part of the push rod.
  • a vertical strip groove is formed which is aligned with the vertical groove of the L-shaped through groove, and a pin hole is symmetrically formed on both side walls of the push ring seat.
  • a pin is inserted between the through groove, the vertical through groove and the pin hole, and the outer circumference of the push ring seat Even with four said fulcrum along a vertically downward direction of the handle bar.
  • a gear 307 is provided in the middle of the wall of the sleeve cylinder, and the gear 307 can mesh with the gear on the gear pressing shaft 21 of the reading device of the present invention, and drive the gear pressing shaft 21 through the fourth motor 26. The rotation of the upper gear causes the meshing gear 307 to rotate to cause the applicator to rotate.
  • the cervical taper applicator of the present invention may further comprise: an angle between the transverse groove length of the L-shaped through groove opened in the lower part of the push rod and the axis of the push rod is 30°, and the taper applicator in the cervix is uncoated.
  • an angle between the transverse groove length of the L-shaped through groove opened in the lower part of the push rod and the axis of the push rod is 30°, and the taper applicator in the cervix is uncoated.
  • the tapered medical foam head is made of a foam having a density of 150 to 200 kg/m 3 or a mixed material of foam and fiber.
  • the color of one of the four fulcrums on the push ring seat (such as red) is different from the color of the other three fulcrums, and the concentric circle formed by the four fulcrums can be designed by default.
  • the four pivot points represent the scale values "3", “6", “9", "12”, and the fulcrum marked with a separate color (such as red) indicates that the scale value is "12".
  • the taper applicator for the cervix is clamped before the use (ie, when the product is shipped), the pin hole on the push ring seat, the vertical groove on the sleeve barrel, and the L-shaped through groove on the push rod are clamped. It is limited to the end of the transverse groove of the L-shaped groove on the push rod (see Figure 7). The push rod cannot directly push the fiber core seeker.
  • the operator holds the handle bar so that the fulcrum indication marked with a separate color (red) on the push ring seat is consistent with the position of the "12" point specified by the cervical sampling; then the handle bar is pressed to make the taper coated
  • the inflated circular disc of the applicator is in full contact with the outer mouth of the cervix, and then the pusher is pressed down by the handle integrally connected with the push rod (the handle cannot be rotated during the period), and the pin that is inserted into the lateral groove of the L-shaped through groove is driven.
  • the shaft drives the push ring seat to move downward along the vertical groove of the sleeve tube (the sleeve is not moved), so that the four fulcrums under the push ring seat push the taper applicator to the surface of the cervix;
  • the handle rotates the push rod to the right by 30°, so that the pin shaft is separated from the limit of the lateral groove of the L-shaped through groove on the push rod into the vertical groove of the L-shaped through groove, and then the push rod is pressed to apply the taper.
  • the fiber core seeker of the device is pushed into the cervical canal, and then the four fulcrums are indicated by the area of the taper applicator for the cervix, that is, the source of the sample and the position of the test can be located.
  • the position of the lesion, the location of the lesion, etc., the product has the advantages of reasonable structure, simple operation, accurate positioning and comfortable use.
  • the diagnosis based on the cervical taper applicator mainly includes the following two methods: one method is to draw the FRD staining solution with a taper applicator, and then after pressing the cervical applicator for 10 seconds, the taper applicator is taken out to observe the taper coating.
  • the color change on the applicator was found to have a blue area, which was judged to be positive, suggesting abnormal cervical lesions (including cervical cancer); another use was to remove cervical secretions and exfoliated cells from the cervix and cervical canal with a taper applicator.
  • the results were interpreted, the following two factors mainly affect the accuracy of the diagnosis results: First, when the results are interpreted, they are generally judged by the doctor or nurse according to their own experience, subjective, especially blue-green. It is especially difficult to distinguish between colors. Since there is no corresponding supporting machine for assistance, the consistency of the positive color is poor, and there is no uniform quality control.
  • the discriminant standard is subjective in implementation, and it is easy to miss or misdiagnose.
  • the color of the dyeing liquid changes from brown to dark brown, which makes the FRD epithelial tissue staining solution vary from batch to batch, so it is different for the same diseased individual in cervical lesion detection.
  • the color of the batch of dyeing solution shows a difference, which affects the accuracy of the test results.
  • the color detected by the color-assisted interpretation device based on the FRD epithelial tissue dyeing applicator according to the present disclosure is caused by problems such as folic acid aging in the staining solution.
  • the result does not correspond to the staining results of the unaged staining solution (if at the factory), resulting in deviations in the interpretation results and producing false positive or false negative results. Therefore, in the judgment of the detection result, it is very necessary to periodically and (for example, one month) use the calibration liquid to calibrate the FRD epithelial tissue dyeing applicator with a color assisted interpretation device.
  • the present disclosure provides a color assisted interpretation device for an FRD epithelial tissue stain applicator to overcome the subjective deficiencies of current positive color discrimination after FRD epithelial tissue staining.
  • the device It has the advantages of high positive color recognition rate, compact structure, reasonable layout, simple operation, and suitable promotion and application.
  • a FRD epithelial dyeing applicator is provided with a color-assisted interpretation device having a base plate on which a device under test is placed side by side (eg, "FRD-dyed" a cervical taper applicator") a detection slot and a horizontal guide, a sample fixing assembly is arranged above the detection slot, and a horizontal drive system of the pulley driven by the second motor is arranged in the horizontal rail, and the horizontal rail is erected on the horizontal rail A vertical guide rail that can move horizontally with the pulley horizontal drive system.
  • a color-assisted interpretation device having a base plate on which a device under test is placed side by side (eg, "FRD-dyed" a cervical taper applicator") a detection slot and a horizontal guide, a sample fixing assembly is arranged above the detection slot, and a horizontal drive system of the pulley driven by the second motor is arranged in the horizontal rail, and the horizontal rail is erected on the horizontal rail A vertical guide rail that can move horizontal
  • a vertical drive system of the pulley driven by the third motor is arranged in the vertical guide rail, and a set of vertical drive system can be vertically arranged on the side of the vertical guide rail.
  • a color sensor for detecting the device under test in the detection tank is disposed on the holder.
  • the lower end of the vertical rail is screwed to the horizontal slider, the pulley drives the horizontal slider, and the horizontal slider and the horizontal rail slide. connection.
  • one end of the sensor holder is screwed to the vertical slider, the pulley drives the vertical slider, and the vertical slider and the vertical rail A sliding connection is used.
  • a mechanism for deflecting the color sensor probe is provided on the sensor mount assembly.
  • the sample fixing assembly disposed above the detecting slot is provided by a side panel, a vertical sliding rail frame, a rack plate, a driving gear splint, and the first Motor, drive gear, strut shaft, fourth motor, rack plate drive gear, the lower part of the two side panels are erected on both sides of the detection slot, and the vertical slide rails are attached to the two side panels.
  • the rack plate is provided with a sliding groove matched with the sliding rail of the vertical sliding rail frame, the rack of the rack plate is meshed with the rack plate driving gear controlled by the fourth motor, and the driving gear clamping plate is fixed on the tooth Below the strip, a drive gear controlled by the first motor is clamped in the drive gear plate, and the pressure rod shaft Both ends of the gear are provided with one end gear meshing with the drive gear, and the other end gear meshing with the gear placed on the device under test in the detecting groove.
  • the device under test (FRD-dyed cervical taper applicator) is first placed in the detection slot, and is pressed by a gear fixed on the shaft of the pressure bar, so that the gear meshes closely with the gear on the device under test.
  • the first motor connected to the pressure rod shaft rotates, the device under test can be rotated by the gear set transmission; then the position of the sensor holder is adjusted by the horizontal rail and the vertical rail to realize accurate three-dimensional positioning of the color sensor;
  • the color sensor is A color-recognizing sensor that uses a 5mm diameter spot to illuminate the object to be measured, and then recognizes the color through the illuminated area; the color sensor transmits the read data to the instrument in real time during the entire movement.
  • the analysis and judgment are performed in the circuit, and the RGB three primary color components of the detected color are compared with the standard reference color to find the positive color point and stored in the memory, and the printer prints after the scanning is completed.
  • the color-assisted interpretation device of the FRD epithelial tissue dyeing applicator of the present disclosure has compact structure, high positive color recognition rate, short detection time, high sensitivity, good detection repeatability and reliability, and can be extended later. It has strong advantages, humanized operation interface and low cost of parts and test consumables. It effectively overcomes the subjective defects of positive color discrimination after FRD epithelial tissue staining, and eliminates the interference of subjective error. Poor consistency and lack of quality control factors, the product is suitable for large-scale promotion and use in the field.
  • the present disclosure also provides a calibrating solution for real-time rapid calibration of a color-assisted interpretation device based on FRD epithelial tissue staining to prevent positive color and preset due to aging of components such as folic acid in the staining solution.
  • the colors are inconsistent, which in turn effectively improves the accuracy of the device to identify FRD staining results.
  • the calibration and calibration of the device by using the calibration liquid of the present disclosure has the advantages of simple operation, short calibration time, and no technical training.
  • the calibrator of the present disclosure is a calibrator used in conjunction with a color-assisted interpretation device for the FRD epithelial tissue stain applicator of the present disclosure to address different batch variations of the FRD epithelial tissue staining solution. The deviation of the interpretation result of the FRD color assisted interpretation device.
  • the calibrator consists of calibrator A1 and calibrator A2.
  • the calibrator A1 comprises 2.44-20% by weight of soluble divalent copper ion salt and 80-97.56% by weight of distilled water;
  • the calibrator A2 comprises 10-40% (such as 30%) of a hydrogen peroxide solution. Since the soluble copper ion salt (such as copper sulfate) and hydrogen peroxide in the calibrating solution are oxidizing, the calibration positive droplets can be clinically positive in the applicator impregnated with the FRD epithelial staining solution. The FRD color of the present disclosure is thus used to assist in the interpretation of the calibration.
  • the soluble divalent copper ion salt may be copper sulfate (CuSO 4 ⁇ 5H 2 O), copper chloride (CuCl 2 ), copper nitrate or the like (Cu(NO 3 ) 2 ) or the like.
  • the soluble divalent copper ion salt may be copper sulfate (CuSO 4 ), and the weight percentage of the soluble divalent copper ion salt in the calibration liquid A1 may be 2.44-20%. Any range between, for example, 2.44-14.89%, 2.44-11.11%, 2.44-6.98%, 6.98-20%, 6.98-14.89%, 6.98-11.11%, 11.11-14.89%, 14.89-20%, 2.44%, 6.98 %, 11.11%, 14.89% or 20%.
  • the soluble divalent copper ion salt is copper sulfate (CuSO 4 .5H 2 O), and the weight percentage of the copper sulfate in the calibrator A1 is 6.98-14.89%.
  • the calibrator A1 is comprised of the following weight percent components: 2.44-20% soluble divalent copper ion salt and 80-97.56% distilled water.
  • the soluble divalent copper ion salt may be copper sulfate (CuSO 4 ⁇ 5H 2 O), copper chloride (CuCl 2 ), copper nitrate or the like (Cu(NO 3 ) 2 ) or the like.
  • the soluble divalent copper ion salt is copper sulfate (CuSO 4 ⁇ 5H 2 O), and its weight percentage in the calibrator A1 may be any range between 2.44-20%.
  • the calibrator A2 can comprise a 30% hydrogen peroxide solution.
  • the calibrator A2 can be a 30% hydrogen peroxide solution.
  • the calibration solution will be used. Dropping on an applicator impregnated with FRD epithelial tissue staining solution, a clinically positive color can be produced, which is then used to calibrate the FRD color-assisted interpretation device.
  • the present disclosure provides a method of preparing a calibrator A1.
  • the calibrator A1 is prepared by dissolving the weight percent soluble copper salt ion in any of the above embodiments in distilled water and stirring to form a calibrator A1.
  • the soluble divalent copper ion salt may be copper sulfate (CuSO 4 ⁇ 5H 2 O), copper chloride (CuCl 2 ), copper nitrate or the like (Cu(NO 3 ) 2 ) or the like.
  • the soluble divalent copper ion salt is copper sulfate (CuSO 4 ⁇ 5H 2 O), and its weight percentage in the calibrator A1 may be any range between 2.44-20%.
  • the present disclosure provides a method of using the calibrating solution of any of the preceding embodiments, the method comprising:
  • the applicator can be a cervical taper applicator as shown in Figures 3-13.
  • Figure 1 is a schematic view showing the structure of one embodiment of the present invention.
  • Figure 2 is a schematic view showing the structure of Figure 1 rotated by a ⁇ angle along the vertical axis.
  • Figure 3 is a schematic illustration of one embodiment of a tapered applicator for a cervix useful in the present invention.
  • Figure 4 is an effect view of the medical foam head of the applicator being pressed by a fulcrum on the push ring seat.
  • Fig. 5 is a schematic view showing the structure of a pusher of the applicator.
  • Figure 6 is a schematic view showing the structure of the sleeve barrel of the applicator.
  • Figure 7 is the limit diagram of the L-shaped groove and the pin shaft when the factory is in the factory state
  • Figure 8 is the position diagram between the L-shaped groove and the pin when the push rod rotates 30°
  • Figure 9 shows the position of the push rod after 30° rotation A positional map between the L-shaped groove and the pin.
  • Figure 10 is a schematic view showing the structure of the push ring holder of the applicator.
  • Figure 11 is a schematic view showing the structure of a hollow tapered foam head of the applicator.
  • Figure 12 is a schematic view showing the structure of a fiber core seeker of the applicator.
  • Figure 13 is a schematic view showing the structure of a specific embodiment of the actual working process of the present invention, wherein the tapered foam head is detected in the schematic view.
  • Figure 14 is a schematic view showing the structure of a specific embodiment of the actual working process of the present invention, wherein the core portion is detected in the schematic view.
  • Figures 1, 2, 13 and 14 are: 1-base plate, 2-horizontal guide rail, 3-detection slot, 4-first motor, 5-second motor, 6-third motor, 7-horizontal slider, 9-vertical rail, 10-vertical slider, 11-reducer, 12-side panel, 13-vertical rail frame, 14-rack plate, 15-drive gear plate, 16- Drive gear, 17-fifth motor, 18-color sensor mount, 21-bar shaft, 22-color sensor deflection angle adjustment shaft, 26-fourth motor, 30-color sensor, 32-sensor deflection drive gear, 33 - Taper applicator, 34-blister box (for placement of taper applicators).
  • the names of the numerical symbols in Figure 3-12 are: 301-hollow tapered foam head, 302-set rod cylinder, 302a-vertical strip channel, 303-fiber core seeker, 304-push rod, 304a-L-shaped trough, 304b-spring connection, 305-pivot, 305a - fulcrum with red label, 306- Push ring seat, 306a-pin hole, 307-gear, 308-spring, 309-pin, 310-fiber core.
  • the cervical taper applicator of the present invention comprises a tapered medical foam head and a handle bar that is upright mounted on the tapered medical foam head.
  • the tapered medical foam head is made of a foam having a density of 150-200 kg/m 3 or a mixed material of foam and fiber, and has a hollow tapered foam head 301 with an enlarged circular disk, which is hollow.
  • the tapered foam head is provided with an inverted T-shaped rivet-shaped fiber core seeker 303 that can move up and down.
  • the handlebar member includes a plastic sleeve cylinder 302 (Fig. 6), a plastic pusher 304 (Fig.
  • Block 306 (Fig. 10).
  • a spring 308 is connected between the bottom end of the push rod 304 and the upper end of the fiber core seeker 303, and an L-shaped through groove 304a is opened in the lower portion of the push rod 304.
  • the two side walls of the sleeve barrel 302 are symmetrically opened.
  • a vertical through groove 302a aligning with the vertical groove of the L-shaped through groove 304a has a pin hole 306a symmetrically formed on both side walls of the push ring seat 306, and an L-shaped through groove 304a and a vertical through groove.
  • a pin 309 is inserted between the 302a and the pin hole 306a to bond the push rod 304, the sleeve barrel 302 and the push ring seat 306 together.
  • the angle between the transverse groove length of the L-shaped through groove opened in the lower part of the push rod 304 and the axis of the push rod 304 is 30°, and the pin (309) is limited when the cervical taper applicator is in the non-coating working state.
  • Positioned in the transverse groove of the L-shaped through groove 304a (see FIG.
  • reference numeral 304b is a spring seat for connecting the spring 308), the push rod 304 cannot push the tapered foam head; After the 304 is rotated 30° to the right, the pin 309 is moved into the vertical groove of the L-shaped through groove 304a (see FIGS. 8-9). At this time, the push rod 304 is pressed to make the fiber core seeker of the foam head. roll out.
  • Four fulcrums 305 are vertically connected to the outer circumference of the push ring seat 306, and a red dot is attached to one of the fulcrums, and the other three fulcrums are affixed with a non-red label.
  • the concentric circles formed by the four fulcrums are defaulted to indicate the dial, and the four fulcrums respectively represent the scale values "3", “6", “9”, “12", and the fulcrums with the red labels are attached.
  • the scale value is "12”. (Without rotating the handle) Pressing the push rod down during use causes the four fulcrums to push the expanded circular disk of the tapered medical foam head 301.
  • a gear 307 is provided in the middle of the sleeve cylinder 302. When used with a matching instrument, the taper applicator for the cervix can be rotated by the gear 307.
  • the area indicates four pivot points, which can locate the source of the sample, the location of the examination, and the location of the lesion.
  • the color-assisted interpretation device for the FRD epithelial tissue dyeing applicator of the present disclosure is mainly composed of two parts fixed on the base plate 1: respectively, the device to be tested (FRD-dyed cervical taper coating) The fixed motion portion of the applicator and the motion control portion of the color sensor.
  • the fixed moving portion of the device to be tested includes a detecting groove 3 for placing the device to be tested and a detecting groove provided therein 3 above the sample fixing assembly, wherein the sample fixing assembly comprises a side panel 12, a vertical rail frame 13, a rack plate 14, a drive gear plate 15, a first motor 4, a drive gear 16, a lever shaft 21, The four motor 26 and the rack plate drive gear are composed.
  • the lower portions of the two side panels 12 are vertically connected to the two sides of the detecting slot 3, and the vertical rail rail plate 13 is attached to the upper portion of the two side panels 12, and the rack plate 14 is provided with a sliding groove which cooperates with the sliding rail of the vertical sliding rail frame 13, the rack of the rack plate 14 meshes with the rack plate driving gear controlled by the fourth motor 26, and the driving gear clamping plate 15 is fixed to the tooth Below the strip 14, a drive gear 16 operated by the first motor 4 is interposed in the drive gear plate 15, and both ends of the press rod shaft 21 are provided with gears, one end of which is meshed with the drive gear 16 and the other end of which is geared.
  • gear 307 meshes.
  • the fourth motor 26 is controlled to move the pressure rod shaft 21 up and down, and the device under test is locked, and then the first motor 4 starts to rotate by the driving gear 16 to rotate the pressure rod shaft 21, thereby driving the device under test in the detecting tank 3. Turn.
  • the motion control portion of the color sensor includes a horizontal rail motion mechanism, a vertical rail motion mechanism, and a sensor mount assembly.
  • the horizontal rail moving mechanism has a horizontal component rail 2 disposed side by side of the detecting slot 3, and a horizontal pulley system driven by the second motor 5 is disposed in the horizontal rail 2.
  • the vertical rail moving mechanism is composed of a vertical rail 9 disposed upright on the horizontal rail 2 and a pulley vertical transmission system disposed in the vertical rail 9.
  • the pulley vertical transmission system is driven by the third motor 6, and the lower end of the vertical rail 9 passes the screw
  • the horizontal slider 7 is fixed on the belt of the pulley horizontal transmission system, and the horizontal slider 7 is simultaneously slidably connected with the horizontal rail 2, and the vertical rail 9 can be horizontally moved with the pulley horizontal transmission system through the above mechanism.
  • One side end of the sensor holder assembly is fixed to the belt of the pulley vertical transmission system by a vertical slider 10 with screws, and the vertical slider 10 is simultaneously slidably coupled with the vertical rail 9 on the sensor holder assembly (fixed by a color sensor)
  • the frame 18) is fixed with a color sensor 30 for detecting the device to be tested mounted in the detecting tank 3.
  • the color sensor 30 can be vertically moved up and down with the pulley horizontal transmission system in the vertical rail 9 by the above mechanism. Also provided on the sensor holder assembly A mechanism for deflecting the color sensor 30 probe, consisting of a fifth motor 17, a sensor deflection drive gear 32, a color sensor deflection angle adjustment shaft 22, etc., the output of the fifth motor 17 in operation is transmitted through the sensor deflection drive gear 32 The shaft 24 is adjusted to the sensor angle to deflect the probe of the color sensor 30.
  • the color sensor 30 is fixed to the color sensor holder 18 by a nut, and is a color-recognizing sensor that irradiates the object to be measured with a spot having a diameter of 5 mm, and then recognizes the color by the irradiated area.
  • the actual working process of the present disclosure is: firstly, the number of pulses sent by each motor is controlled by the computer control device matched with the device, so that the motor has a specific motion track; then the instrument starts to start the self-test process, including the initialization and color of each motor position.
  • the gear on the pressure rod shaft 21 is driven by the first motor 4 to mesh with the gear on the device under test; the color sensor 30 starts detecting the pivot point of the test object with the red label attached thereto, and the pressure rod shaft 21 rotates at a constant speed, to be recognized.
  • the conical surface of the device to be tested ie, the foam head 301 of the cervical taper applicator
  • the subject is rotated by 10°, and the color sensor is along its specific
  • the surface is scanned once until the surface (360°) scan is completed; then the illumination angle of the color sensor probe 30 can be adjusted by the color sensor probe deflection mechanism to start detecting the device under test.
  • the cylindrical rod surface i.e., the fiber core portion 310 of the cervical taper applicator
  • the color sensor 30 is relatively perpendicular to the surface of the device to be tested, and is detected by the reciprocating motion of the color sensor 30 in the horizontal direction.
  • the position of the sensor of the color sensor 30 during scanning and the positional distance when the device under test is scanned are relatively constant.
  • the working motors of the horizontal axis, the vertical axis and the color sensor angle adjustment axis must be moved together by the single chip microcomputer.
  • the horizontal guide 2 drives the color sensor 30 to move horizontally
  • the vertical guide 9 drives the color sensor 30 to reciprocate up and down
  • the color sensor angle adjustment shaft 22 changes the angle of the color sensor 30, and the scanned color sensor 30 transmits the read data to the instrument in real time. Analyze and judge among the matched circuits to find the positive color point and store it in the memory. After the scan is completed, the printer is printed by the printer matched with the device; after the overall detection is completed, the color sensor 30 and each motor are restored. initial position.
  • the calibrator A1 is configured for each component specified in Table 1 below; color calibration calibration is performed on the FRD color assisted discriminating device with the calibrators A1 and A2; The color color results were standard and the FRD epithelial tissue stain applicator was used to identify the accuracy of the FRD staining results using a color assisted interpretation device.
  • the specific detection method and the method for testing the accuracy of the color-assisted interpretation device for the FRD epithelial tissue dyeing applicator are as follows:
  • the calibration liquid A1 is configured for each component specified in Table 1 below, and the calibration liquid A2 is configured; the color calibration calibration of the FRD color auxiliary discrimination device is performed by the calibration liquids A1 and A2, specifically
  • the steps are as follows: (a) putting the applicator used in the FRD staining solution bottle with the FRD epithelial tissue dyeing applicator of the present invention into the FRD staining solution bottle, and pressing down the dyeing solution during the drawing process.
  • Example 3 The procedure of Example 3 was repeated according to the contents of the respective components specified in Table 1 below, and the results are shown in Table 1.
  • Example 3 The procedure of Example 3 was repeated according to the contents of the respective components specified in Table 1 below, and the results are shown in Table 1.
  • the use of the calibrator of the present disclosure can significantly improve the accuracy of the color-assisted interpretation device for the FRD epithelial tissue dyeing applicator of the present disclosure, indicating that the calibrator of the present disclosure is significantly superior to the prior art. Standard liquid is often specified.

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Abstract

一种FRD上皮组织染色涂敷器用颜色辅助判读装置，以及可用于该装置的定标液及其使用方法。所述装置具有一个底座板（1），在底座板（1）上并排设置有一个被测件检测槽（3）和一个水平导轨（2），在检测槽（3）的上方设置有样本固定组件，在水平导轨（2）内设有皮带轮水平传动系统，在水平导轨（2）上直立设置有一个可随皮带轮水平传动系统做水平向运动的垂直导轨（9），在垂直导轨（9）内设有皮带轮垂直传动系统，在垂直导轨（9）侧部设有一套可随皮带轮垂直传动系统做竖直向运动的传感器固定架（18），在固定架（18）上设置有用于对检测槽（3）内装被测件进行检测的颜色传感器（30）。所述定标液有效地提高了FRD颜色辅助判读装置识别FRD染色结果的准确度。

Description

FRD上皮组织染色涂敷器用颜色辅助判读装置及定标液
相关申请的交叉引用
本申请要求2016年10月21日提交的发明名称为:“FRD上皮组织染色涂敷器用颜色辅助判读装置”的中国实用新型专利201621145910.X的优先权。在先申请的内容通过提述以其整体并入本文。
技术领域
本发明专利属于生物医学检测技术领域，特别涉及FRD上皮组织染色涂敷器用颜色辅助判读装置，定标液及其使用方法。
背景技术
目前，在宫颈病变检测中，基于FRD(叶酸受体介导的诊断,folic receptor-mediated diagnosis)上皮组织染色液的染色法属于新型上皮细胞检测技术。FRD上皮组织染色液由叶酸衍生物、还原态亚甲蓝、乙酸等组成，呈棕色。其检测机理主要为：与正常细胞相比，肿瘤细胞表面叶酸受体成高表达[1,2]、活性氧增多，同时肿瘤细胞对铁需求增加，并对亚甲蓝有高度亲和性。将FRD上皮组织染色液涂抹于宫颈上皮组织后，如果有肿瘤细胞存在，叶酸衍生物与叶酸受体结合，将叶酸衍生物连同亚甲蓝内吞进入细胞；在Fe2+催化下，还原态亚甲蓝被胞内活性氧氧化成氧化态的亚甲蓝，由无色变为蓝色；由于这些大分子的进入，使得胞内渗透压升高，致使氧化态亚甲蓝逸出细胞，因此可在医用聚胺酯棉或脱脂棉签上直接观察显示出的颜色，据此判断宫颈上皮是否存在异常病变[3]。也可以使用与前述染色液配套使用的宫颈锥度涂敷器来进行诊断。
与本发明的FRD上皮组织染色涂敷器用颜色辅助判读装置配合使用的宫颈锥度涂敷器的一个非限制性实例可以是图3至图13中示出的结构，所述宫颈锥度涂敷器具有一个由泡棉或泡棉纤维混合材料制成的锥形医用泡 棉头和一副直立连装在锥形医用泡棉头上的手柄杆件的结构，其中所述锥形医用泡棉头具有一个带膨大圆形盘的中空锥形泡棉头(301)，在中空锥形泡棉头内穿装有一个可上下活动的纤维芯导引头(303)；所述的手柄杆件包括一个套杆筒(302)、一根穿装在套杆筒(302)内的推杆(304)和一个外套在套杆筒(302)下部的推环座(306)，在推杆(304)底端与纤维芯导引头(303)上端之间连接有弹簧(308)，在推杆(304)下部正中开有一个L形通槽(304a)，在套杆筒(302)的两侧壁上对称各开有一个与L形通槽(304a)的竖向槽对位的竖条通槽(302a)，在推环座(306)的两侧壁上对称各开有一个销孔(306a)，在L形通槽(304a)、竖条通槽(302a)和销孔(306a)之间插装有一根销轴(309)，在推环座(306)的外周对称连设有四个可沿手柄方向垂直向下的支点(305)。在套杆筒(302)壁的中部套装有一个可通过本发明颜色辅助判读装置的压杆轴21上的齿轮带动转动所述涂覆器的齿轮(307)。推杆(304)下部所开L形通槽的横向槽长与推杆(304)轴线间的夹角为30°，在宫颈用锥度涂敷器处于非涂敷工作状态时，由外至内依次穿过销孔(306a)及竖条通槽(302a)的销轴(309)穿装在销孔(306a)的横向槽内。
本发明中可与FRD上皮组织染色涂敷器用颜色辅助判读装置配套使用的宫颈用锥度涂敷器的非限制性实例还可以为：所提供的宫颈用锥度涂敷器具有一个由泡棉或泡棉纤维混合材料制成的锥形医用泡棉头和一副直立连装在锥形医用泡棉头上的手柄杆件，其中：所述的锥形医用泡棉头具有一个带膨大圆形盘的中空锥形泡棉头，在中空锥形泡棉头内穿装有一个可上下活动的铆钉状纤维芯导引头；所述的手柄杆件包括一个套杆筒、一根穿装在套杆筒内的推杆和一个外套在套杆筒下部的推环座，在推杆底端与纤维芯导引头上端之间连接有弹簧，在推杆下部正中开有一个L形通槽，在套杆筒的两侧壁上对称各开有一个与L形通槽的竖向槽对位的竖条通槽，在推环座的两侧壁上对称各开有一个销孔，在L形通槽、竖条通槽和销孔之间插装有一根销轴，在推环座的外周对称连设有四个可沿手柄杆件方向垂直向下的支点。 另外，在套杆筒壁的中部套装有一个齿轮307，该齿轮307可与本发明的所述判读装置的齿轮压杆轴21上的齿轮啮合，并通过第四电机26驱动齿轮压杆轴21上的齿轮的转动而带动啮合的齿轮307转动从而使所述涂覆器发生转动。
另外，本发明的宫颈用锥度涂敷器还可以包括：推杆下部所开L形通槽的横向槽长与推杆轴线间的夹角为30°，在宫颈用锥度涂敷器处于非涂敷工作状态时，由外至内依次穿过销孔及竖条通槽的销轴穿装在销孔的横向槽内。
上述宫颈用锥度涂敷器中，锥形医用泡棉头由密度为150～200kg/m3的泡棉或泡棉和纤维的混合材料制成。
上述宫颈用锥度涂敷器中，设于推环座上四个支点中的一个支点的颜色(如红色)与其它三个支点的颜色相异，设计时可将由四个支点形成的同心圆默认为指示刻度盘，四个支点分别表示刻度数值“3”，“6”，“9”，“12”，标有单独异色(如红色)的支点表示刻度数值为“12”。
上述宫颈用锥度涂敷器在使用前(即产品出厂状态时)，穿推环座上销孔、套杆筒上竖条通槽及推杆上L形通槽而设的销轴被卡装限位在推杆上L形通槽之横向槽的末端(参见图7)，推杆对纤维芯导引头不能直接推动。具体使用时，操作者握住手柄杆件，使推环座上标有单独异色(红色)的支点指示与宫颈采样指定的“12”点位置保持一致；然后按压手柄杆件，使得锥度涂敷器的膨大圆形盘与宫颈外口全面接触，之后再通过与推杆一体连接的手柄向下按压推杆(期间不能旋转手柄)，驱使卡装在L形通槽之横向槽内的销轴带动推环座沿套杆筒上的竖条通槽向下运动(套杆筒不动)，进而使推环座下的四个支点推动锥度涂敷器贴紧宫颈表面；之后再旋拧手柄将推杆向右旋转30°，使销轴脱离推杆上L形通槽之横向槽的限位进入L形通槽之竖向槽，其后再按压推杆，则可将锥度涂敷器的纤维芯导引头推入宫颈管，之后结合宫颈用锥度涂敷器的区域指示四个支点，即可以定位样本的来源、检查的位 置、病变的位置等，产品具有结构合理、操作简单、可以准确定位且使用舒适等优点。
基于所述宫颈锥度涂敷器进行诊断主要包括以下两种方法：一种方法是用锥度涂敷器蘸取FRD染色液，然后在宫颈涂抹按压10秒后，取出锥度涂敷器，观察锥度涂敷器上的颜色变化，发现有蓝色区域，即判断为阳性，提示宫颈异常病变(包括宫颈癌)；另一种用法是用锥度涂敷器从宫颈及宫颈管取出宫颈分泌物及脱落细胞后，再放置于FRD染色液瓶中染色30秒，取出锥度涂敷器观察其上的颜色变化，发现有蓝色区域，则提示上皮组织发生异常病变(如宫颈癌)。现有技术在结果判读时，主要有以下两个因素影响诊断结果的准确性：首先，在结果判读时，一般都是由医生或护士根据自己的经验肉眼判断，存在主观性，尤其出现蓝绿间色时判别尤为困难。由于没有相应配套机器进行辅助，所判别阳性颜色的一致性差，也没有统一的质量控制，判别标准在实施时存在主观性，很容易出现漏诊或者误诊的现象。另外，由于叶酸等成分老化引起的染色液颜色由棕色向深棕色变化的一个过程，使得不同批次间的FRD上皮组织染色液会存在差异，因此在宫颈病变检测中对于同一患病个体，不同批次的染色液所表现出的颜色存在差异，从而影响检测结果的准确性。具体应用中，如果以染色液中推荐的颜色作为判断宫颈病变的标准，则由于染色液中叶酸老化等问题，用基于本公开的FRD上皮组织染色涂敷器用颜色辅助判读装置所检测到的颜色结果无法与未老化的染色液(如出厂时)的染色结果相对应，从而导致判读结果的偏差，并产生假阳性或假阴性结果。因此在检测结果的判断上，十分需要定期(如一个月)使用定标液对FRD上皮组织染色涂敷器用颜色辅助判读装置进行定标。
发明内容
一方面，本公开提供了FRD上皮组织染色涂敷器用颜色辅助判读装置，以克服目前FRD上皮组织染色后阳性颜色判别的主观性缺陷。所述装置具 有阳性颜色识别率高、结构紧凑、布局合理、操作简单，和适宜推广应用等优点。
为了实现以上的发明目的，在一个技术方案中，所提供的FRD上皮组织染色涂敷器用颜色辅助判读装置具有一个底座板，在底座板上并排设置有一个被测件(如“FRD染色后的宫颈锥度涂敷器”)检测槽和一个水平导轨，在检测槽的上方设置有样本固定组件，在水平导轨内设有一副由第二电机驱动的皮带轮水平传动系统，在水平导轨上直立设置有一个可随皮带轮水平传动系统做水平向运动的垂直导轨，在垂直导轨内设有一副由第三电机驱动的皮带轮垂直传动系统，在垂直导轨侧部设有一套可随皮带轮垂直传动系统做竖直向运动的传感器固定架，在固定架上设置有用于对检测槽内装被测件进行检测的颜色传感器。
在一个实施方案中，上述FRD上皮组织染色涂敷器用颜色辅助判读装置中，垂直导轨的下端用螺钉固定在水平滑块上，皮带轮带动水平滑块运动，水平滑块与水平导轨之间采用滑动连接。
在一个实施方案中，上述FRD上皮组织染色涂敷器用颜色辅助判读装置中，传感器固定架的一侧端用螺钉固定在垂直滑块上，皮带轮带动垂直滑块运动，垂直滑块与垂直导轨之间采用滑动连接。
在一个实施方案中，上述FRD上皮组织染色涂敷器用颜色辅助判读装置中，在传感器固定架组件上设有用于使颜色传感器探头偏转的机构。
在一个实施方案中，上述FRD上皮组织染色涂敷器用颜色辅助判读装置中，设置在检测槽上方的样本固定组件由侧面板、竖向滑轨架板、齿条板、驱动齿轮夹板、第一电机、驱动齿轮、压杆轴、第四电机、齿条板驱动齿轮组成，两个侧面板的下部直立连装在检测槽的两侧，竖向滑轨架板连装在两个侧面板的上部，齿条板上设有与竖向滑轨架板上滑轨配合的滑槽，齿条板的齿条与由第四电机操控的齿条板驱动齿轮相啮合，驱动齿轮夹板固定在齿条板的下方，在驱动齿轮夹板内夹装有由第一电机操控的驱动齿轮，压杆轴 的两端均套装齿轮，其一端齿轮与驱动齿轮相啮合，另一端齿轮可与放置在检测槽内的被测件上的齿轮相啮合。
实际工作中，首先将被测件(FRD染色后的宫颈锥度涂敷器)放入检测槽，由固定在压杆轴上的齿轮进行压紧，使得该齿轮与被测件上齿轮紧密啮合，与压杆轴连接的第一电机转动后,通过齿轮组传动可以使被测件进行转动；之后通过水平导轨和垂直导轨调整传感器固定架的位置,实现颜色传感器三维立体的准确定位；颜色传感器是一种能识别颜色的传感器，工作中采用直径5mm的光斑照射到被测物体上，然后通过所照射区域来识别颜色；整个运动过程中颜色传感器将所读到的数据进行实时传入仪器所配套的电路当中进行分析和判断，通过检测颜色的RGB三原色分量与标准参考色进行比对,找出阳性颜色点并存储到内存当中，扫描完成后由打印机进行打印。
与现有技术相比，本公开的FRD上皮组织染色涂敷器用颜色辅助判读装置具有结构紧凑、阳性颜色识别率高、检测时间短、灵敏度高、检测重复性和可靠性较好、后期可扩展性强、操作界面人性化易操作以及所需零部件和试验耗材成本低等优点，它有效克服了目前FRD上皮组织染色后阳性颜色判别存在的主观性缺陷，排除了人为主观性误差的干扰、一致性差和缺少质控的因素，产品适宜于本领域大面积推广和使用。
另一方面，本公开还提供了一种定标液，以实现对基于FRD上皮组织染色的颜色辅助判读装置及时快速定标，防止由于染色液中叶酸等成分老化而导致阳性颜色与预先设定的颜色不一致，进而有效提高了该装置识别FRD染色结果的准确性。另外，用本公开的定标液对前述装置进行校准定标，具有操作简便，定标时间短，不需技术培训等优点。
在一个实施方案中，本公开的定标液是配合本公开所述的FRD上皮组织染色涂敷器用颜色辅助判读装置使用的定标液，以解决FRD上皮组织染色液不同批次差异所导致的FRD颜色辅助判读装置判读结果的偏差。
在一个具体的实施方案中，所述定标液由定标液A1和定标液A2组成， 定标液A1包含重量百分比为2.44-20％的可溶性二价铜离子盐和重量百分比为80-97.56％的蒸馏水；定标液A2包含10-40％(如30％)的过氧化氢溶液。由于前述定标液中的可溶性铜离子盐(如硫酸铜)及过氧化氢具有氧化性，将定标液滴在浸有FRD上皮组织染色液的涂敷器上，则能出现临床阳性颜色，从而用该定标液对本公开的FRD颜色辅助判读准定标。
在一个具体的实施方案中，所述可溶性二价铜离子盐可以是硫酸铜(CuSO4·5H2O)、氯化铜(CuCl2)、硝酸铜等(Cu(NO3)2)等。
在一个具体的实施方案中，所述可溶性二价铜离子盐可以是硫酸铜(CuSO4)，且所述可溶性二价铜离子盐在定标液A1中的重量百分比可以是2.44-20％之间的任何范围，例如2.44-14.89％、2.44-11.11％、2.44-6.98％、6.98-20％、6.98-14.89％、6.98-11.11％、11.11-14.89％、14.89-20％、2.44％、6.98％、11.11％、14.89％或20％。
在一个具体的实施方案中，所述可溶性二价铜离子盐是硫酸铜(CuSO4·5H2O)，且所述硫酸铜在定标液A1中的重量百分比为6.98-14.89％。
在一个具体的实施方案中，所述定标液A1由以下重量百分比的组分组成：2.44-20％的可溶性二价铜离子盐和80-97.56％的蒸馏水。在一个具体的实施方案中，所述可溶性二价铜离子盐可以是硫酸铜(CuSO4·5H2O)、氯化铜(CuCl2)、硝酸铜等(Cu(NO3)2)等。在一个具体的实施方案中，所述可溶性二价铜离子盐是硫酸铜(CuSO4·5H2O)，且其在定标液A1中的重量百分比可以是2.44-20％之间的任何范围，例如2.44-14.89％、2.44-11.11％、2.44-6.98％、6.98-20％、6.98-14.89％、6.98-11.11％、11.11-14.89％、14.89-20％、2.44％、6.98％、11.11％、14.89％或20％。
在一个具体的实施方案中，所述定标液A2可以包含30％的过氧化氢溶液。
在一个具体的实施方案中，所述定标液A2可以是30％的过氧化氢溶液。
如上所述，由于该定标液中的硫酸铜及过氧化氢具有氧化性，将定标液 滴在浸有FRD上皮组织染色液的涂敷器上，则能出现临床阳性颜色，进而用其对FRD颜色辅助判读装置校准定标。
第三方面，本公开提供了一种定标液A1的制备方法。
在一个具体的实施方案中，所述定标液A1的制备方法为：将前述任一实施方案中的重量百分比的可溶性二价铜盐离子溶于蒸馏水后，搅拌，形成定标液A1。在一个具体的实施方案中，所述可溶性二价铜离子盐可以是硫酸铜(CuSO4·5H2O)、氯化铜(CuCl2)、硝酸铜等(Cu(NO3)2)等。在一个具体的实施方案中，所述可溶性二价铜离子盐是硫酸铜(CuSO4·5H2O)，且其在定标液A1中的重量百分比可以是2.44-20％之间的任何范围，例如2.44-14.89％、2.44-11.11％、2.44-6.98％、6.98-20％、6.98-14.89％、6.98-11.11％、11.11-14.89％、14.89-20％、2.44％、6.98％、11.11％、14.89％或20％。
第四方面，本公开提供了前述任一实施方案中的定标液的使用方法，所述方法包括：
(a)将所述涂敷器放入FRD染色液瓶中蘸取染液，为了使所述涂敷器能够充分吸收染液，蘸取过程中向下按压所述涂敷器；
(b)将定标液A1约500μl均匀滴加到蘸取FRD上皮组织染色液的所述涂敷器头部，再将500μl的定标液A2(如30％过氧化氢溶液)均匀滴加到所述涂敷器头部；
(c)待所述涂敷器头部的颜色均匀变为蓝色后，用其对FRD颜色辅助判读装置进行颜色校准定标。
在一个具体的实施方案中，前述各步骤都是在常压下进行的。
在一个具体的实施方案中，所述涂敷器可以是图3-13中所示的宫颈锥度涂敷器。
附图说明
图1是本发明一个具体实施方式的结构示意图。
图2是图1所示装置沿竖向轴旋转π角的结构示意图。
图3是可用于本发明的宫颈用锥度涂敷器的一个具体实施方式的结构示意图。
图4是通过推环座上的支点按压所述涂敷器的医用泡棉头的效果图。
图5是所述涂敷器的的推杆的结构示意图。
图6是所述涂敷器的套杆筒的结构示意图。
图7-9是所述涂敷器的推杆旋转30°过程的分解图。其中图7为出厂状态时L形通槽与销轴的限位结合图；图8为推杆旋转30°时L形通槽与销轴间的位置图；图9为推杆旋转30°后L形通槽与销轴间的位置图。
图10是所述涂敷器的推环座的结构示意图。
图11是所述涂敷器的中空锥形泡棉头的结构示意图。
图12是所述涂敷器的纤维芯导引头的结构示意图。
图13为本发明实际工作过程的一个具体实施方式的结构示意图，其中该示意图中检测的是锥形泡棉头。
图14为本发明实际工作过程的一个具体实施方式的结构示意图，其中该示意图中检测的是芯部。
其中，图1、2、13和14中数字标号名称分别是：1－底座板，2－水平导轨，3－检测槽，4－第一电机，5－第二电机，6－第三电机，7－水平滑块，9－垂直导轨，10－垂直滑块，11－减速机，12－侧面板，13－竖向滑轨架板，14－齿条板，15－驱动齿轮夹板，16－驱动齿轮，17－第五电机，18－颜色传感器固定架，21－压杆轴，22－颜色传感器偏转角度调整轴，26－第四电机，30－颜色传感器，32－传感器偏转驱动齿轮，33－锥度涂敷器，34－吸塑盒(放置锥度涂敷器用)。
其中，图3-12中各数字标号的名称分别是：301－中空锥形泡棉头，302－套杆筒，302a－竖条通槽，303－纤维芯导引头，304－推杆，304a－L形通槽，304b－弹簧连接座，305－支点，305a—贴有红色标签的支点，306－ 推环座，306a－销孔，307－齿轮，308－弹簧，309－销轴，310－纤维芯部。
实施例
本说明书涉及多个实施例。提供以下公开内容是为了使本领域普通技术人员能够实施本发明。本说明书中使用的语言不应被解释为任何一个具体实施例的一般否定，或者用于将权利要求限制在其中使用的术语的含义之外。在不脱离本发明的精神和范围的情况下，本文定义的一般原理可以应用于其他实施例和应用。此外，所使用的术语和措辞是用于描述示例性实施例的目的，并且不应被认为是限制性的。因此，本发明应被给予包括与所公开的原理和特征一致的许多替代，修改和等同物的最宽范围。为了清楚起见，没有详细描述与本发明相关的技术领域中已知的与技术材料有关的细节，以免不必要地模糊本发明。
实施例1
参见图3-13，本发明所述的宫颈用锥度涂敷器包括锥形医用泡棉头和直立连装在锥形医用泡棉头上的手柄杆件。其中，锥形医用泡棉头由密度为150～200kg/m3的泡棉或泡棉和纤维的混合材料制成，它具有一个带膨大圆形盘的中空锥形泡棉头301，在中空锥形泡棉头内穿装有一个可上下活动的倒T形铆钉状的纤维芯导引头303。所述的手柄杆件包括一个塑料套杆筒302(图6)、一根穿装在套杆筒302内的塑料推杆304(图5)和一个外套在套杆筒302下部的塑料推环座306(图10)。在推杆304底端与纤维芯导引头303上端之间连接有弹簧308，在推杆304下部正中开有一个L形通槽304a，在套杆筒302的两侧壁上对称各开有一个与L形通槽304a的竖向槽对位的竖条通槽302a，在推环座306的两侧壁上对称各开有一个销孔306a，在L形通槽304a、竖条通槽302a和销孔306a之间插装有一根销轴309，从而将推杆304、套杆筒302和推环座306结合在一起。推杆304下部所开L形通槽 的横向槽长与推杆304轴线间的夹角为30°，平时(即宫颈用锥度涂敷器处于非涂敷工作状态时)，销轴309被限位在L形通槽304a之横向槽内(参见图7，图中标号304b为用于连接弹簧308的弹簧座)，推杆304不能推挤锥形泡棉头；使用时通过手柄将推杆304向右旋转30°后，使销轴309运动至L形通槽304a之竖向槽内(参见图8-图9)，此时按压推杆304可使泡棉头的纤维芯导引头推出。在推环座306的外周对称连设有四个可沿手柄方向垂直向下的支点305，其中一个支点处贴有红色标签，另外三个支点均贴非红色标签。具体设计结构中，将将四个支点形成的同心圆默认为指示刻度盘，四个支点分别表示刻度数值“3”，“6”，“9”，“12”，贴有红色标签的支点表示刻度数值为“12”。(在不旋转手柄情况下)使用时向下按压推杆，即可使四个支点推压锥形医用泡棉头301的膨大圆形盘。在套杆筒302的中部设有一个齿轮307，在与配套仪器使用时，可通过齿轮307转动宫颈用锥度涂敷器。
实际应用中，操作者握住手柄使贴有红色标签支点的指示与宫颈“12”点的位置保持一致时，按压套杆筒302，使得锥度涂敷器的膨大圆形盘与宫颈外口全面接触；然后再通过手柄向下按压推杆304，使锥度涂敷器底面的四个支点305推动锥度涂敷器贴紧宫颈表面，整个过程中不能旋转手柄；随后将推杆304向右旋转30°，使销轴309脱离推杆上的L形通槽4a之横向槽的卡位后，再按压推杆304，使锥度涂敷器的纤维芯进入宫颈管；之后结合宫颈用锥度涂敷器的区域指示四个支点，可以定位样本的来源、检查的位置和病变的位置等。
实施例2
参见附图1和2，本公开所述的FRD上皮组织染色涂敷器用颜色辅助判读装置主要由固定在底座板1上的两大部分构成：分别是被测件(FRD染色后的宫颈锥度涂敷器)的固定运动部分和颜色传感器的运动控制部分。
被测件的固定运动部分包括用于放置被测件的检测槽3和设置在检测槽 3上方的样本固定组件，其中的样本固定组件由侧面板12、竖向滑轨架板13、齿条板14、驱动齿轮夹板15、第一电机4、驱动齿轮16、压杆轴21、第四电机26、齿条板驱动齿轮组成，两个侧面板12的下部直立连装在检测槽3的两侧，竖向滑轨架板13连装在两个侧面板12的上部，齿条板14上设有与竖向滑轨架板13上滑轨配合的滑槽，齿条板14的齿条与由第四电机26操控的齿条板驱动齿轮相啮合，驱动齿轮夹板15固定在齿条板14的下方，在驱动齿轮夹板15内夹装有由第一电机4操控的驱动齿轮16，压杆轴21的两端均套装齿轮，其一端齿轮与驱动齿轮16相啮合，另一端齿轮可与放置在检测槽3内的被测件(如本发明中所述的宫颈用锥度涂敷器)上的齿轮(如在前述宫颈用锥度涂敷器的套杆筒302的中部设有的齿轮307)相啮合。工作时控制第四电机26使压杆轴21上下运动，将被测件锁紧然后由第一电机4开始通过驱动齿轮16转动带动压杆轴21转动，进而带动检测槽3内的被测件转动。
颜色传感器的运动控制部分包括水平导轨运动机构、垂直导轨运动机构以及传感器固定架组件。其中水平导轨运动机构具有一个并行设置在检测槽3侧旁的水平组件导轨2，在水平导轨2内设有由第二电机5驱动的皮带轮水平传动系统。垂直导轨运动机构由直立设置在水平导轨2上的垂直导轨9以及在垂直导轨9内设置的皮带轮垂直传动系统组成，皮带轮垂直传动系统由第三电机6驱动，垂直导轨9的下端通过带有螺钉的水平滑块7固定在皮带轮水平传动系统的传动带上，水平滑块7同时与水平导轨2滑动连接，通过上述机构可使垂直导轨9随皮带轮水平传动系统做水平向运动。传感器固定架组件的一侧端通过带有螺钉的垂直滑块10固定在皮带轮垂直传动系统的传动带上，垂直滑块10同时与垂直导轨9滑动连接，在传感器固定架组件上(通过颜色传感器固定架18)固定有用于对检测槽3内装有的被测件进行检测的颜色传感器30，通过上述机构可使颜色传感器30随垂直导轨9内的皮带轮水平传动系统做竖直向上下运动。另外在传感器固定架组件上还设有 由第五电机17、传感器偏转驱动齿轮32、颜色传感器偏转角度调整轴22等组成的用于使颜色传感器30探头偏转的机构,工作中第五电机17的输出通过传感器偏转驱动齿轮32将扭矩传递到传感器角度调整轴24，使颜色传感器30的探头偏转。颜色传感器30用螺母固定在颜色传感器固定架18上，是一种能识别颜色的传感器，采用直径5mm的光斑进行照射到被测物体上，然后通过所照射区域来识别颜色。
本公开的实际工作过程是：首先通过本装置配套的计算机控制装置控制各个电机发送的脉冲数，使其电机具有特定的运动轨迹；然后启动仪器开始自检过程，包括各个电机位置的初始化和颜色传感器30扫描位置的初始化，仪器初始化启动完成后将被测件(如，FRD染色后的宫颈锥度涂敷器)放入检测槽3中，启动第四电机26驱动使压杆轴21下压，由第一电机4驱动压杆轴21上的齿轮与被测件上齿轮进行啮合转动；颜色传感器30开始检测被测件贴有红色标签的支点，此时压杆轴21匀速转动，待识别到贴有红色标签的支点后，先检测被测件的锥形曲面(即，所述宫颈锥度涂敷器之泡棉头301)，被测件每转过10°，颜色传感器即沿其特定的曲面扫描一次，直至该曲面(360°)扫描完成；之后可通过颜色传感器探头偏转机构调整颜色传感器探头30的照射角度，开始检测被测件的圆柱杆体曲面(即，所述宫颈锥度涂敷器之纤维芯部310)，颜色传感器30与被测件面相对垂直，通过颜色传感器30在水平方向上的来回往复运动来进行检测。整个运动过程中，颜色传感器30在扫描时的传感器位置和被测件被扫描时的位置距离要求相对恒定，通过单片机控制水平轴、垂直轴和颜色传感器角度调整轴的各工作电机必须共同运动，水平导轨2带动颜色传感器30水平移动，垂直导轨9带动颜色传感器30上下往复运动，颜色传感器角度调整轴22改变颜色传感器30的角度，扫描后颜色传感器30将所读到的数据进行实时传入仪器所配套的电路当中进行分析和判断，找出阳性颜色点并存储到内存当中，扫描完成后由与本装置配套的打印机进行打印；整体检测完成后使颜色传感器30和各个电机恢复 初始位置。
实施例3
在常温和常压下，分别以下表1中指定的各组分配置定标液A1；用定标液A1和A2对FRD颜色辅助判别装置进行颜色校准定标；以锥度涂敷器海绵头蓝色颜色结果为标准，测试FRD上皮组织染色涂敷器用颜色辅助判读装置识别FRD染色结果的准确性。
其中具体的检测方法和测试FRD上皮组织染色涂敷器用颜色辅助判读装置的准确性的测定方法如下：
在常温和常压下，分别以下表1中指定的各组分配置定标液A1，并配置定标液A2；用定标液A1和A2对FRD颜色辅助判别装置进行颜色校准定标，具体步骤为：(a)将与本发明的FRD上皮组织染色涂敷器用颜色辅助判读装置配套使用的涂敷器放入FRD染色液瓶中蘸取染液，并在蘸取过程中向下按压所述涂敷器；(b)将前述配置的定标液A1约500μl均匀滴加到蘸取FRD上皮组织染色液的所述涂敷器头部，再将前述配置的500μl的定标液A2均匀滴加到所述涂敷器头部；(c)待所述涂敷器头部的颜色均匀变为蓝色后，用其作为阳性结果，对FRD颜色辅助判读装置进行颜色校准定标；然后用本发明的颜色辅助判读装置检测30例阳性(蓝色、蓝黑色)锥度涂敷器和30例阴性(棕色、绿色)锥度涂敷器。最后，通过以下方法计算识别FRD染色结果的准确性并列于表1中：
准确性＝[(正确检测出的阳性例数+正确检测出的阴性例数)/总检测例数]×100％
实施例4
按以下表1中指定的各组分含量重复实施例3的方法，结果见表1。
实施例5
按以下表1中指定的各组分含量重复实施例3的方法，结果见表1。
对比例1
在常温和常压下，称取3.05g高锰酸钾，溶于96.95ml蒸馏水中，盖上表面皿，加热至沸腾，并保持微沸状态数分钟，冷却后过滤，制成溶液B。将涂敷器浸泡于FRD上皮组织染色液约30秒后，将溶液B均匀滴加到涂敷器上，再将30％过氧化氢溶液均匀滴加到涂敷器上，40秒后涂敷器变蓝色，用该定标液的染色结果作为阳性结果，对FRD颜色辅助判别装置进行颜色校准定标。然后用本发明的颜色辅助判读装置检测30例阳性(蓝色、蓝黑色)锥度涂敷器和30例阴性(棕色、绿色)锥度涂敷器。最后，通过以下方法计算识别FRD染色结果的准确性并列于表1中：
准确性＝[(正确检测出的阳性例数+正确检测出的阴性例数)/总检测例数]×100％
对比例2
在常温和常压下，称取2.68g硫酸亚铁，量取97.32ml蒸馏水边加边搅拌直到彻底溶解，制成溶液C。将锥度涂敷器浸泡于FRD上皮组织染色液约30秒后，将溶液C均匀滴加到涂敷器上，40秒后涂敷器变蓝色，用该定标液的染色结果作为阳性结果，对FRD颜色辅助判别装置进行颜色校准定标。然后用本发明的颜色辅助判读装置检测30例阳性(蓝色、蓝黑色)锥度涂敷器和30例阴性(棕色、绿色)锥度涂敷器。最后，通过以下方法计算识别FRD染色结果的准确性并列于表1中：
准确性＝[(正确检测出的阳性例数+正确检测出的阴性例数)/总检测例数]×100％
表1
Figure PCTCN2017106901-appb-000001
从上述表1可以看出，使用本公开的定标液能够显著提高使用本公开的FRD上皮组织染色涂敷器用颜色辅助判读装置的准确性，说明本公开的定标液显著优于现有技术常规定标液。
上述实施例仅仅是本发明的系统的许多应用的说明。尽管这里仅描述了本发明的几个实施例，但是应当理解，在不脱离本发明的精神或范围的情况下，本发明可以以许多其它具体形式实施。因此，本实施例和实施方案被认为是说明性的而不是限制性的，并且可以在所附权利要求的范围内修改本发明。
参考文献
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[2]Tang X,Dai H,Zhu Y,etal.Maytansine-loaded star-shaped folate-core  PLA-TPGS nanoparticles enhancing anticancer activity[J].Am J Transl Res. 2014；6(5):528-537.
[3]Wang H, Liu C, Gong X, etal. In vivo photoacoustic molecular imaging of breast carcinoma with folate receptor-targeted indocyanine green nanoprobes[J]. Nanoscale.2014；6(23): 14270-14279.

Claims (17)

  1. FRD上皮组织染色涂敷器用颜色辅助判读装置，其特征在于：具有一个底座板(1)，在底座板(1)上并排设置有一个被测件检测槽(3)和一个水平导轨(2)，在检测槽(3)的上方设置有样本固定组件，在水平导轨(2)内设有一副由第二电机(5)驱动的皮带轮水平传动系统，在水平导轨(2)上直立设置有一个可随皮带轮水平传动系统做水平向运动的垂直导轨(9)，在垂直导轨(9)内设有一副由第三电机(6)驱动的皮带轮垂直传动系统，在垂直导轨(9)侧部设有一套可随皮带轮垂直传动系统做竖直向运动的传感器固定架组件，在固定架组件上设置有用于对检测槽(3)内装被测件进行检测的颜色传感器(30)。
  2. 根据权利要求1所述的FRD上皮组织染色涂敷器用颜色辅助判读装置，其特征在于：垂直导轨(9)的下端通过带有螺钉的水平滑块(7)固定在皮带轮水平传动系统的传动带上，水平滑块同时与水平导轨(2)滑动连接。
  3. 根据权利要求1或2所述的FRD上皮组织染色涂敷器用颜色辅助判读装置，其特征在于：传感器固定架组件的一侧端通过带有螺钉的垂直滑块(10)固定在皮带轮垂直传动系统的传动带上，垂直滑块(10)同时与垂直导轨(9)滑动连接。
  4. 根据权利要求1至3中任一项所述的FRD上皮组织染色涂敷器用颜色辅助判读装置，其特征在于：在传感器固定架组件上设有用于使颜色传感器(30)探头偏转的机构。
  5. 根据权利要求1至4中任一项所述的FRD上皮组织染色涂敷器用颜色辅助判读装置，其特征在于：设置在检测槽(3)上方的样本固定组件由侧面板(12)、竖向滑轨架板(13)、齿条板(14)、驱动齿轮夹板(15)、第一电机(4)、驱动齿轮(16)、压杆轴(21)、第四电机(26)、齿条板驱动齿轮组成，两个侧面板(12)的下部直立连装在检测槽(3)的两侧，竖向滑轨架板(13)连装在两个侧面板(12)的上部，齿条板(14)上设有与竖向滑轨架板(13)上滑轨配合的滑槽， 齿条板(14)的齿条与由第四电机(26)操控的齿条板驱动齿轮相啮合，驱动齿轮夹板(15)固定在齿条板(14)的下方，在驱动齿轮夹板(15)内夹装有由第一电机(4)操控的驱动齿轮(16)，压杆轴(21)的两端均套装齿轮，其一端齿轮与驱动齿轮(16)相啮合，另一端齿轮可与放置在检测槽(3)内的被测件上的齿轮相啮合。
  6. 用于基于FRD上皮组织染色的颜色辅助判读装置定标的定标液，其中所述定标液包含定标液A1和定标液A2，所述定标液A1包含以下重量百分比的可溶性二价铜离子盐2.44-20％和蒸馏水80-97.56％，以及所述定标液A2包含10-40％的过氧化氢溶液。
  7. 根据权利要求6所述的定标液，其中所述定标液A1由以下重量百分比的可溶性二价铜离子盐2.44-20％和蒸馏水80-97.56％组成，所述定标液A2由10-40％，优选30％的过氧化氢溶液组成。
  8. 根据权利要求6-7中任一项所述的定标液，其中所述可溶性二价铜离子盐选自硫酸铜(CuSO4·5H2O)、氯化铜(CuCl2)、硝酸铜(Cu(NO3)2)。
  9. 根据权利要求6-8中任一项所述的定标液，其中所述可溶性二价铜离子盐是硫酸铜(CuSO4·5H2O)，和/或所述可溶性二价铜离子盐在定标液A1中的重量百分比为2.44-20％之间的任何范围，例如2.44-14.89％、2.44-11.11％、2.44-6.98％、6.98-20％、6.98-14.89％、6.98-11.11％、11.11-14.89％、14.89-20％、2.44％、6.98％、11.11％、14.89％或20％。
  10. 根据权利要求6-7中任一项所述的定标液，所述可溶性二价铜离子盐是硫酸铜(CuSO4·5H2O)，且所述硫酸铜在定标液A1中的重量百分比为6.98-14.89％。
  11. 根据权利要求6-10中任一项所述的定标液，其中所述判读装置优选为权利要求1-5中任一项所述的FRD上皮组织染色涂敷器用颜色辅助判读装置。
  12. 权利要求6-11中任一项的定标液的使用方法，包括以下步骤：
    (a)将所述涂敷器放入FRD染色液瓶中蘸取染液，并在蘸取过程中向下按压所述涂敷器；
    (b)将定标液A1均匀滴加到蘸取FRD上皮组织染色液的所述涂敷器头部，再将定标液A2均匀滴加到所述涂敷器头部，优选地定标液A1和A2的量为500μl；
    (c)待所述涂敷器头部的颜色均匀变为蓝色后，用其对FRD颜色辅助判读装置进行颜色校准定标。
  13. 根据权利要求12的使用方法，其中上述各步骤均在常压下进行。
  14. 用于权利要求6-13中任一项所述的定标液的试剂盒，所述试剂盒包含权利要求6-13中任一项所述的定标液。
  15. 权利要求1-5中任一项所述的FRD上皮组织染色涂敷器用颜色辅助判读装置在检测宫颈异常病变(如宫颈癌)中的用途。
  16. 权利要求6-11中任一项所述的用于基于FRD上皮组织染色的颜色辅助判读装置定标的定标液在检测宫颈异常病变(如宫颈癌)中的用途。
  17. 权利要求14所述的试剂盒在检测宫颈异常病变(如宫颈癌)中的用途。
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