CN102908123B - A kind of device for allergy test and its preparation method and application - Google Patents
A kind of device for allergy test and its preparation method and application Download PDFInfo
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- CN102908123B CN102908123B CN201210347939.6A CN201210347939A CN102908123B CN 102908123 B CN102908123 B CN 102908123B CN 201210347939 A CN201210347939 A CN 201210347939A CN 102908123 B CN102908123 B CN 102908123B
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- 238000012360 testing method Methods 0.000 title claims abstract description 147
- 206010020751 Hypersensitivity Diseases 0.000 title claims abstract description 22
- 208000026935 allergic disease Diseases 0.000 title claims abstract description 22
- 230000007815 allergy Effects 0.000 title claims abstract description 22
- 238000002360 preparation method Methods 0.000 title claims abstract description 16
- 238000000034 method Methods 0.000 claims abstract description 18
- 239000000463 material Substances 0.000 claims description 60
- 239000000853 adhesive Substances 0.000 claims description 27
- 230000001070 adhesive effect Effects 0.000 claims description 25
- 229920000642 polymer Polymers 0.000 claims description 9
- 230000000717 retained effect Effects 0.000 claims description 8
- 239000004744 fabric Substances 0.000 claims description 7
- 210000003491 skin Anatomy 0.000 description 18
- 238000007789 sealing Methods 0.000 description 12
- 239000010408 film Substances 0.000 description 10
- 238000007731 hot pressing Methods 0.000 description 10
- 239000007788 liquid Substances 0.000 description 8
- 238000003825 pressing Methods 0.000 description 7
- 229910052782 aluminium Inorganic materials 0.000 description 6
- XAGFODPZIPBFFR-UHFFFAOYSA-N aluminium Chemical compound [Al] XAGFODPZIPBFFR-UHFFFAOYSA-N 0.000 description 6
- 239000000835 fiber Substances 0.000 description 6
- 239000010409 thin film Substances 0.000 description 6
- 235000003932 Betula Nutrition 0.000 description 4
- 241000219429 Betula Species 0.000 description 4
- 235000001543 Corylus americana Nutrition 0.000 description 4
- 240000007582 Corylus avellana Species 0.000 description 4
- 235000007466 Corylus avellana Nutrition 0.000 description 4
- 238000013461 design Methods 0.000 description 4
- 210000000245 forearm Anatomy 0.000 description 4
- 238000002347 injection Methods 0.000 description 4
- 239000007924 injection Substances 0.000 description 4
- 239000012528 membrane Substances 0.000 description 4
- 238000004519 manufacturing process Methods 0.000 description 3
- 238000011017 operating method Methods 0.000 description 3
- 239000004033 plastic Substances 0.000 description 3
- 229920003023 plastic Polymers 0.000 description 3
- 238000006748 scratching Methods 0.000 description 3
- 230000002393 scratching effect Effects 0.000 description 3
- 239000013543 active substance Substances 0.000 description 2
- 239000002313 adhesive film Substances 0.000 description 2
- 230000002411 adverse Effects 0.000 description 2
- 239000013566 allergen Substances 0.000 description 2
- 230000008901 benefit Effects 0.000 description 2
- 239000000470 constituent Substances 0.000 description 2
- 208000002925 dental caries Diseases 0.000 description 2
- 230000000694 effects Effects 0.000 description 2
- 210000002615 epidermis Anatomy 0.000 description 2
- 238000011156 evaluation Methods 0.000 description 2
- 238000011049 filling Methods 0.000 description 2
- 239000006261 foam material Substances 0.000 description 2
- 239000003365 glass fiber Substances 0.000 description 2
- 229910052751 metal Inorganic materials 0.000 description 2
- 239000002184 metal Substances 0.000 description 2
- 239000013308 plastic optical fiber Substances 0.000 description 2
- 239000007787 solid Substances 0.000 description 2
- 206010040880 Skin irritation Diseases 0.000 description 1
- 239000002390 adhesive tape Substances 0.000 description 1
- 238000004458 analytical method Methods 0.000 description 1
- 238000003556 assay Methods 0.000 description 1
- 238000013096 assay test Methods 0.000 description 1
- 230000009286 beneficial effect Effects 0.000 description 1
- 238000004140 cleaning Methods 0.000 description 1
- 239000011248 coating agent Substances 0.000 description 1
- 238000000576 coating method Methods 0.000 description 1
- 238000005520 cutting process Methods 0.000 description 1
- 230000007547 defect Effects 0.000 description 1
- 238000001514 detection method Methods 0.000 description 1
- 238000005516 engineering process Methods 0.000 description 1
- 230000009969 flowable effect Effects 0.000 description 1
- 238000002372 labelling Methods 0.000 description 1
- 238000011068 loading method Methods 0.000 description 1
- 238000004321 preservation Methods 0.000 description 1
- 238000012545 processing Methods 0.000 description 1
- 230000036556 skin irritation Effects 0.000 description 1
- 231100000475 skin irritation Toxicity 0.000 description 1
- 238000003860 storage Methods 0.000 description 1
Classifications
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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
- A61B5/41—Detecting, measuring or recording for evaluating the immune or lymphatic systems
- A61B5/411—Detecting or monitoring allergy or intolerance reactions to an allergenic agent or substance
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B10/00—Other methods or instruments for diagnosis, e.g. instruments for taking a cell sample, for biopsy, for vaccination diagnosis; Sex determination; Ovulation-period determination; Throat striking implements
- A61B10/0035—Vaccination diagnosis other than by injuring the skin, e.g. allergy test patches
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/20—Surgical instruments, devices or methods, e.g. tourniquets for vaccinating or cleaning the skin previous to the vaccination
- A61B17/205—Vaccinating by means of needles or other puncturing devices
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- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Surgery (AREA)
- Molecular Biology (AREA)
- General Health & Medical Sciences (AREA)
- Biomedical Technology (AREA)
- Heart & Thoracic Surgery (AREA)
- Medical Informatics (AREA)
- Veterinary Medicine (AREA)
- Animal Behavior & Ethology (AREA)
- Engineering & Computer Science (AREA)
- Public Health (AREA)
- Pathology (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Immunology (AREA)
- Vascular Medicine (AREA)
- Physics & Mathematics (AREA)
- Biophysics (AREA)
- Investigating Or Analysing Biological Materials (AREA)
Abstract
The invention provides a kind of device for allergy test, described device comprises test cell and indexing unit, described test cell comprises multiple container unit and the counterdie for being connected described multiple container unit, described container unit comprises the container for holding anaphylactogen, described indexing unit and described test cell adjoin and arrange, wherein, described container unit also comprises needle device, and described needle device is arranged in the bottom interior wall of described container.Present invention also offers method and the application of this device in the product tested for the preparation of allergy of this device of preparation.
Description
Technical field
The present invention relates to a kind of device for allergy test, and the preparation method of this device, and the application of this device in the product tested for the preparation of allergy.
Background technology
Patent EP1695666B1 discloses a kind of device for carrying out irritated test, and this device is with a container unit and a cover plate unit.By removing its coverlay, container unit can be fixed on cover plate unit effectively, the situation that there will not be anaphylactogen to spill between cover plate unit and container unit or obscure.After on cover plate unit is placed to (such as) experimenter's forearm, by cutting the instrument of drawing or instrument of pinking to be cut by the through hole on cover plate instrument and draws or injured skin, then tearing the closing membrane of closed container off and container unit is turned on cover plate unit.The anaphylactogen being arranged in container arrives the skin site be damaged by through hole, so just can observe the reaction of the experimenter to various anaphylactogen.
But, this patent has been come mainly through through hole corresponding with container unit on cover plate unit and continuous cut groove, this is divided into two steps to carry out the preparation of test zone and test operation with regard to needing, not only add the complexity of test set, also add operating procedure, extend the operating time.Meanwhile, if produce disposable skin irritation that is straight, that do not stop by continuous cut groove, then this continuous cut groove likely can cause the phenomenon of leakage between different vessels after container unit adhesion.
The container unit of this patent is by one deck adhesive film or at least have the design of adhesive film to complete the adhesion of itself and cover plate unit in local.This operation relates to container unit is rotated 180 °, if anaphylactogen liquid thus will be made not spill in switching process, then need spongy material to be fixed on container unit and control the addition of liquid, or need to keep container unit level when rotated, this design can increase the complexity of device and operating process.
In addition, the container chamber disclosed in this patent is made up of aluminum closing membrane and counterdie, is closed aluminum closing membrane adds the spongy material in container chamber at anaphylactogen after with counterdie by hot pressing.At this moment, the heat in hot-press sealed process can cause damage to anaphylactogen.If the damage of heat to anaphylactogen of hot pressing will be reduced to greatest extent; all many-sides such as seriality and forming shape that then sealing of container chamber, closing membrane throw off process will be restricted; this is also unfavorable for the protection to anaphylactogen and spongy material, and may affect actual operating experience.
Also need at present to seek a kind of structure more simple, more convenient to operate and efficiently for the device of allergy test.
Summary of the invention
Therefore, the object of the invention is to overcome the complex structure existing for irritated testing equipment of the prior art, operate lengthy and tedious defect, there is provided a kind of structure simple, easy to operate fast for the device of allergy test, and prepare the method for this device, and the application of this device in the product tested for the preparation of allergy.
The invention provides a kind of device for allergy test, described device comprises test cell 1 and indexing unit 2, described test cell comprises multiple container unit 3 and the counterdie 4 for being connected described multiple container unit, described container unit 3 comprises the container 6 for holding anaphylactogen, described indexing unit 2 is arranged with described test cell 1 is adjacent, wherein, described container unit also comprises needle device 7, and described needle device is arranged in the bottom interior wall of described container.
Described test cell 1 can be designed as the structure of flat, can be such as a kind ofly there is multiple groove and other parts are the structure of plane substantially, in addition, the material that described test cell can use this area conventional, but preferably frivolous, pliable and tough material, such as polymer, is preferably plastics, can matches with test zone (forearm as the experimenter) better thus.
For realizing object of the present invention; those skilled in the art know, and the constituent material of described test cell itself should be enough firm, to avoid producing distortion when gentle touchdown; then described needle device can be avoided to puncture described teleblem, thus protection container is in order to avoid it lose sealing in advance.Thus, described test cell can be preferably aluminum, or described container unit can be aluminum laminated films.
Described needle device can substitute in prior art for scratching the needle-like scoring devices of superficial skin.When practical operation, by applying pressure (such as by a stable pressing plate) to the container dorsal part of each container unit, the needle device carrying anaphylactogen can be thrust in the concrete test position (as epiderm skin) in test zone.Described needle device can be a kind of sharps, it can be such as the sharps (such as metal sharps) that mechanical strength is larger, also, as sharps, fibre bundle wherein compares the operation being suitable for dry active substance can to use high rigidity fiber or fibre bundle (such as glass fibre or hard and sharp-pointed plastic optical fibre).In a vessel, described needle device can be one, also can be two or more.Under the prerequisite that can realize the object of thrusting superficial skin, described needle device can be arranged in the bottom interior wall of described container in any way, the bottom interior wall angulation of such as described needle device and container can be between 0 ~ 90 °, described needle device is preferably perpendicular to the bottom interior wall of described container, again such as, if the material of container inner wall is polymer, then can by heat the mode of this polymer make described needle device and bottom interior wall inter-adhesive, with fixing described needle device, or the circulus identical with container bottom size can be set bottom described needle device, by the mode of physics, described needle device is stuck in the bottom of bowl, etc..
Described anaphylactogen can be liquid, also can arrange in the above-described container with the form of solid, gel, paste or lyophilizing shape.When needle device is designed to the sharps with lyophilizing shape anaphylactogen, the spongy material 8 of preservation and fixing anaphylactogen in described container, can be there is no need for.
According to device of the present invention, wherein, described needle device 7 can be arranged to be basically perpendicular to the mode of the bottom interior wall of described container 6.
According to device of the present invention, wherein, spongy material 8 can be provided with in described container 6, and described needle device 7 runs through described spongy material.Described spongy material can be the material that this areas such as spongiform high molecular foam material, spongiform non-woven cloth fabric material or sponge are commonly used.Described spongy material can be fixed better and preserve liquid allergen, and when container tightness is destroyed, can slow down damage and the spilling of anaphylactogen.
According to device of the present invention, wherein, the wall shape structure 9 that described container unit 3 can also comprise the edge of opening around described container 6 and arrange, and described wall shape structure forms a part for the sidewall of described container.As preferably, the top of described needle device 7 can substantially with the top end of the edge of opening of described container or described wall shape structure at grade.Described wall shape structure can separate different anaphylactogens effectively.Those skilled in the art can thrust the degree of depth by the described height of wall shape structure of adjustment and the deformation extent of described container unit with what regulate needle device.Consider the top of needle device as higher than as described in container opening or as described in the top of wall shape structure time, adverse effect may be caused to teleblem, and as lower than as described in container opening or as described in the top of wall shape structure time, that then may strengthen needle device thrusts difficulty, therefore preferably, described needle device top can substantially with the top end of the edge of opening of described container or described wall shape structure at grade.Described wall shape structure by particularly advantageous mode, can be fixed when teleblem hot pressing being covered on container unit.
According to device of the present invention, wherein, the cross section of described container 6 can be circle, rectangle or square.Circle can be preferably.
According to device of the present invention, wherein, described test cell 1 can also comprise the teleblem 5 covered on described container unit 3 and described counterdie 4, for closing described container unit.So, when described teleblem is combined with wall shape structure, the sealing of container unit can be improved better, can also effectively prevent needle device from transport or operation, unconsciously opening described container.As preferably, by using flexible double-sided adhesive material layer 10 by mode mutually bonding with described counterdie 4 for described teleblem 5, described teleblem can be covered on described container unit and described counterdie.As more preferably, described flexible double-sided adhesive material layer can not covering container unit, and its thickness is basic equal with the height of described wall shape structure 9.When use flexible double-sided adhesive material layer by teleblem and counterdie mutual bonding time, due to the thickness of flexible double-sided adhesive material layer and the height of wall shape structure roughly equal, and it is covering container unit not, thus the space between teleblem because wall shape structure causes and counterdie can be filled, effectively prevent the edge of opening (or upper end-face edge of wall shape structure) that teleblem is only pasted on container unit like this, what make between two films is bonding more firm, opens more continuous.
According to device of the present invention, wherein, described flexible double-sided adhesive material layer 10 can be upper and lower surface through the high molecular polymer of viscosity process or medical proof fabric.The utilization of this material can make more have seriality when opening between teleblem and counterdie, prevents from opening the apparatus vibration produced when pasting two uneven film.As further preferably, described teleblem 5 is from after described test cell 1 is removed, and at least part of described flexible double-sided adhesive material layer will be retained on described test cell, and described test cell can be attached on test zone.For ease of opening, described teleblem can form outstanding shape in different directions from flexible double-sided adhesive material layer and counterdie or have different edges.Such as the part of described teleblem and/or described flexible double-sided adhesive material layer can exceed the edge of described counterdie, so that be easy in use open described teleblem, and/or is easy to remove described test cell to leave indexing unit.
According to device of the present invention, wherein, animal pattern, cartoon pattern or strip cartoon can be printed in the back side of described counterdie 4.This patterned arrangement form is attached in the process of test zone the feared state of mind can eliminated child and test allergy at test cell.In addition, in container unit, the shape of container also can be designed to various shape, color or quantity, all can need to adjust according to child.
According to device of the present invention, wherein, described indexing unit 2 is fixed on the side of described test cell 1 removably, and at least part of with adhesives towards test zone side of described indexing unit, removes described test cell when making indexing unit be retained on test zone.As preferably, indexing unit described at least one can be fixed on the side of described test cell along perforation line 11.As preferably, an indexing unit respectively can be fixed at two of described test cell relative sides.For antipollution appearance, the adhesive material on indexing unit can cover by the protecting film that can take off.
According to device of the present invention, wherein, described device is only made up of described test cell 1 and described indexing unit 2.
The present invention also provides a kind of method preparing device of the present invention, described preparation method comprises to be injected the step in described container 6 and described teleblem 5 is covered the step on described container unit 3 and counterdie 4 by anaphylactogen, wherein, the step injected by anaphylactogen in described container is carried out after described teleblem being covered the step on described container unit and described counterdie.When described teleblem be cover by the mode of hot pressing and close described container time, method of the present invention can avoid the damage that in hot pressing, heat causes anaphylactogen.Owing to closing between teleblem and container before injection anaphylactogen, thus those skilled in the art can by the method for injection, such as penetrate described teleblem or anaphylactogen is injected container by described chamber wall, or through hole can be set in the scope of described teleblem facing to vessel port, this through hole is preferably arranged on described teleblem facing to the center in the scope of vessel port, by this through hole, anaphylactogen is injected, then use ultrasonic or ultraviolet sealing tech to be closed in involved hole.When employing spongy material, those skilled in the art should know, usually after being arranged at by spongy material in described container, then carry out teleblem to cover the step on described container unit (on the opening namely covering described container or in described wall shape structure) and described counterdie.
Present invention also offers the application of device of the present invention in the product tested for the preparation of allergy.
Specifically, the present invention devises a kind of device for allergy test, and this device is made up of test cell and indexing unit.Test cell comprises multiple container unit and the counterdie being connected described multiple container unit, container unit is with the container for holding anaphylactogen, needle device is integrated on the aluminum film bottom container unit, test cell also comprises the teleblem covered on described container unit and counterdie, with the aperture for loading anaphylactogen on this teleblem.There is the flexible double-sided adhesive material layer of one deck local continuous that whole device is bonded as one between teleblem and counterdie.After the step of filling anaphylactogen, the filling hole on teleblem will be closed by ultrasonic or ultraviolet sealing tech.
The advantage of this device is: by means of only an operating procedure (namely removing teleblem), just whole checkout gear can be fixed firmly to the surface of test skin.Do not need extra device to carry out pretreatment to skin, but by being integrated in the needle device of container unit, complete skin pretreatment through unified pressing.Due to unnecessary device and the situation spilling or obscure occurring anaphylactogen can not be operated between container unit.Because the phase just adds anaphylactogen after the production, this device can avoid the damage that in hot pressing closed process, heat causes anaphylactogen effectively.In addition, after enough action time, whole test cell can take off from irritated test zone and clear.At this moment indexing unit will be separated with test cell, stay test zone.
Device of the present invention and its preparation method and application has but is not limited to following beneficial effect:
1. device of the present invention can separate different anaphylactogen effectively, increases the sealing of test section, affects irritated test result, thus improve the accuracy of irritated test between the anaphylactogen avoiding different test position because polluting mutually.
2. device of the present invention can be fixed on region to be measured by the simplest mode, and effectively anaphylactogen is delivered to tested person region by minimum step.Specifically, by the modifying device in the present invention, operator only needs to throw off teleblem and just test cell and indexing unit can be fixed on test zone and carry out allergy test, thus relative to prior art, this invention simplifies operating procedure, reduce operation easier, decrease the set-up mode of spongy material simultaneously and quantitative limitation is added to anaphylactogen, and then be conducive to carrying out more convenient allergy test.
3. the design of many kinds of needle device makes this device more effective to the pretreatment of epidermis, and by increasing epidermis processing area, this device can effectively reduce anaphylactogen working concentration.Thus, while not affecting detection accuracy and stability, reduce production cost further.
4. this device is by the use to wall shape structure, will increase the sealing of each container unit and tested skin further.What formed when independently wall shape structure also helps fixed press needle device thrusts the degree of depth.In transport, storage, this wall shape structure is conducive to protection container unit not by outside destroy.
5. the preparation method of apparatus of the present invention can reduce the damage to anaphylactogen effectively.Relative to prior art, the preparation method of the present invention to device is improved, it is not deferred to this area and usually first inserts the method that anaphylactogen carries out sealing again, but first carry out sealing inserting anaphylactogen more off the beaten trackly, when can reduce or eliminate hot pressing teleblem like this, heat is to the damage of anaphylactogen, thus improves the degree of accuracy of irritated test.
Accompanying drawing explanation
Below, describe embodiment of the present invention in detail by reference to the accompanying drawings, wherein:
Fig. 1 shows the top view of device of the present invention, and anaphylactogen titles such as " hazels ", " Betula " in figure is only schematic record, should not be construed as and carries out any restriction to the anaphylactogen of this device;
Fig. 2 shows the sectional view of device of the present invention along A-A line;
Fig. 3 shows the top view of device of the present invention after opening teleblem, and wherein figure right side is depicted as teleblem, and anaphylactogen titles such as " hazels ", " Betula " in figure is only schematic record, should not be construed as and carries out any restriction to the anaphylactogen of this device;
Fig. 4 shows device of the present invention after opening teleblem, along the top view of B-B line;
Fig. 5 shows device of the present invention after opening teleblem, along the top view of C-C line;
Fig. 6 shows the schematic top plan view of device of the present invention when opening part teleblem, and anaphylactogen titles such as " hazels ", " Betula " in figure is only schematic record, should not be construed as and carries out any restriction to the anaphylactogen of this device;
Fig. 7 shows the schematic top plan view of device of the present invention when removing part (upper left corner) counterdie and test cell, anaphylactogen titles such as " hazels ", " Betula " in figure is only schematic record, should not be construed as and carries out any restriction to the anaphylactogen of this device.
Detailed description of the invention
Further illustrate the present invention below by specific embodiment, but should be understood to, these embodiments are only used for the use specifically described more in detail, and should not be construed as limiting the present invention in any form.
Test cell 1 and indexing unit 2 is comprised for the device of allergy test in the present invention.Described test cell 1 can be designed as the structure of flat, can be such as a kind ofly there is multiple groove and other parts are the structure of plane substantially, in addition, the material that described test cell can use this area conventional, but preferably frivolous, pliable and tough material, such as polymer, is preferably plastics, can matches with test zone (forearm as the experimenter) better thus.But for realizing object of the present invention, those skilled in the art know; the constituent material of described test cell 1 itself should be enough firm; to avoid producing distortion when gentle touchdown, described needle device 7 then can be avoided to puncture described teleblem 5, thus protection container is in order to avoid it lose sealing in advance.Thus, this test cell 1 also can be preferably aluminum laminated films.
Also cavity thin film can be used as test cell, and cavity thin film comprises two-layer parallel thin film, and they are with network-like mutually bonding, thus forms many cavitys mutually closed, and these cavitys can as container.Wherein, the thin film of use is thinner and pliable and tough, and before double-layer films is mutually bonding, wherein thin film is placed in the forming bottom plate with corresponding recesses, and the anaphylactogen of various liquid can load on these thin film be in groove in the later stage.
Described indexing unit 2 is arranged with described test cell 1 is adjacent.Such as, described indexing unit 2 is fixed on the side of described test cell 1 removably, and at least part of with adhesive material towards test zone side of described indexing unit 2, removes described test cell 1 when making indexing unit 2 be retained on test zone.After test cell 1 is removed from test zone, at least one indexing unit 2 being similar to adhesive tape is retained near test zone, like this, according to indexing unit 2 information that provides of test zone side dorsad, clearly a certain anaphylactogen can be mapped with a certain concrete test position in test zone, to carry out assay to allergy test.Correspondingly, the corresponding informance between anaphylactogen and a certain concrete test position no longer by the form of color or paster, but is applied directly on skin, and can successfully take off from skin after irritated test analysis evaluation terminates.As preferably, described indexing unit 2 can carry out dismountable fixing along perforation line 11, the benefit of this design is that described test cell 1 and described indexing unit 2 can be produced in same production stage.For antipollution appearance, the adhesive material on indexing unit 2 can cover by the protecting film that can take off.For guaranteeing reliably to be attached on test zone as far as possible, indexing unit 2 can all with adhesive material towards the side of skin.As preferably, respectively can fix an indexing unit 2 at two of described test cell 1 relative sides, more corresponding informance can be provided like this, and better indicative function can be had when anaphylactogen kind is more.
Described test cell 1 and indexing unit 2 have toughness and can bend, and can adapt with the warp architecture of skin surface or domes.Such as, described test cell 1 and indexing unit 2 can be made up of thin plastic layer, can increase coating if desired by appropriate ways.
Described test cell 1 comprises multiple container unit 3, and container unit 3 comprises the container 6 for holding anaphylactogen.Described container unit 3 also can be fixed on described test cell 1 removably, namely described container unit 3 also can be pulled down from test cell 1, like this, when removing described test cell 1 from test zone, described container unit 3 can continue to be attached on test zone, or container unit 3 and indexing unit 2 can together continue to be attached on test zone, container unit 3 can be removed after certain hour, then carry out irritated testing evaluation by the corresponding informance on indexing unit 2.
Described container unit 3 can be arranged on described test cell 1 in the usual manner, such as, can be the two row's container units 3 be parallel to each other.Also can be (observing from depression angle) animal pattern, cartoon pattern or heart pattern etc., such arrangement form can weaken or eliminate the feared state of mind that child tests allergy.In addition, described container 6 can be designed as arbitrary shape, color and quantity, and the cross section of such as described container 6 can be circle, rectangle or square, can be preferably circle.
Described container unit 3 also comprises needle device 7, and described needle device 7 is arranged in the bottom interior wall of described container 6.Described needle device 7 can substitute in prior art for scratching the needle-like scoring devices of superficial skin, when reality uses, by applying pressure (such as by a stable pressing plate) to container 6 dorsal part of each container unit 3, the needle device 7 carrying anaphylactogen can be thrust in the concrete test position (as skin surface) in test zone.Described needle device 7 can be a kind of sharps, it can be such as the sharps (such as metal sharps) that mechanical strength is larger, also, as sharps, fibre bundle wherein compares the operation being suitable for dry active substance can to use high rigidity fiber or fibre bundle (such as glass fibre or hard and sharp-pointed plastic optical fibre).In a container 6, described needle device 7 can be one, also can be two or more.Under the prerequisite that can realize the object scratching superficial skin, described needle device 7 can be arranged in the bottom interior wall of described container 6 in any way, such as the bottom interior wall angulation of described needle device 7 and container 6 can be between 0 ~ 90 °, as needle device 7 can perpendicular to as described in the bottom interior wall of container 6, again such as, if the material of container 6 inwall is polymer, then can by heat the mode of this polymer make described needle device and bottom interior wall inter-adhesive, with fixing described needle device 7, or the circulus identical with size bottom container 6 can be set bottom described needle device 7, by the mode of physics, described needle device 7 is stuck in the bottom of bowl, etc..
Described anaphylactogen can be liquid, also can arrange in the above-described container with the form of solid, gel, paste or lyophilizing.When needle device is designed to the sharps with lyophilizing formula anaphylactogen, in described container, spongy material 8 can not be needed.
Wall shape structure 9 can be set at the edge of opening of container, and described wall shape structure 9 forms a part for the sidewall of described container 6.As preferably, the top of described needle device 7 can substantially with the top end of the edge of opening of described container 6 or described wall shape structure 9 at grade.Described wall shape structure 9 can separate the anaphylactogen in each different vessels effectively, and described wall shape structure 9 can contact with skin around the concrete test position of in test zone, thus can also effectively mutually seal each concrete test position, the anaphylactogen belonging to a concrete test position can not arrive another concrete test position.In addition, those skilled in the art can thrust the degree of depth by the described height of wall shape structure 9 of adjustment and the deformation extent of described container unit 3 with what regulate needle device.Consider the top of needle device 7 as higher than as described in container 6 opening or as described in the top of wall shape structure 9 time, adverse effect may be caused to teleblem, and as lower than as described in container 6 opening or as described in the top of wall shape structure 9 time, that then may strengthen needle device 7 thrusts difficulty, therefore preferably, described needle device 7 top can substantially with the top end of the edge of opening of described container 6 or described wall shape structure 9 at grade.Described wall shape structure 9 by particularly advantageous mode, can be fixed to when preparing container chamber on counterdie 4, or fixes when teleblem 5 hot pressing being covered on container unit 3.
Can be provided with spongy material 8 in described container, and described needle device 7 runs through described spongy material 8.Spongy material 8 can be the material that this areas such as spongiform high molecular foam material, spongiform non-woven cloth fabric material or sponge are commonly used.Described spongy material 8 can be fixed better and preserve liquid allergen, and when container tightness is destroyed, can slow down damage and the spilling of anaphylactogen.
Described test cell 1 can also comprise the teleblem 5 covered on described container unit 3 and described counterdie 4, for closing described container unit 3, the anaphylactogen in container and/or spongy material can be preserved for a long time and the object of testing for allergy.When described teleblem 5 is combined with wall shape structure 9, the sealing of container unit 3 can be improved better, can also effectively prevent needle device 7 from transport or operation, unconsciously opening described container 6.As preferably, described teleblem 5 with flexible double-sided adhesive material layer 10 can be used between counterdie 4 mutually bonding, so that teleblem 5 is covered on described container unit 3 and counterdie 4.
Described flexible double-sided adhesive material layer 10 can be upper and lower surface through the high molecular polymer of viscosity process or medical proof fabric.The utilization of this material can make more have seriality when opening between teleblem 5 and counterdie 4, prevents from opening the apparatus vibration produced when pasting two uneven film.As further preferably, described teleblem 5 is from after described test cell 1 is removed, and at least part of described flexible double-sided adhesive material layer 10 is retained on described test cell 1, and described test cell 1 can be attached on test zone.For ease of opening, described teleblem 5 can form outstanding shape in different directions from flexible double-sided adhesive material layer 10 and counterdie 4 or have different edges.Such as the part of described teleblem 5 and/or described flexible double-sided adhesive material layer 10 can exceed the edge of described counterdie 4, so that be easy in use open described teleblem 5, and/or is easy to remove described test cell 1 to leave indexing unit 2.
When described teleblem 5 be cover by the mode of hot pressing and close described container 6 time, the present invention prepares in the method for described device, anaphylactogen will be injected in described container chamber after described teleblem 5 covers on described container unit 3 and counterdie 4, can avoid the damage that in hot pressing, heat causes anaphylactogen like this.Owing to closing between teleblem 5 and container 6 before injection anaphylactogen, thus those skilled in the art can by the method for injection, such as penetrate described teleblem or anaphylactogen is injected container by described chamber wall, or through hole can be set in the scope of described teleblem facing to vessel port, this through hole is preferably arranged on described teleblem facing to the center in the scope of vessel port, by this through hole, anaphylactogen is injected, then use ultrasonic or ultraviolet sealing tech to be closed in involved hole.When employing spongy material, those skilled in the art should know, usually after being arranged at by spongy material in described container, then the step of (on the opening namely covering described container or in described wall shape structure) is carried out teleblem to cover on described container unit.
Device of the present invention can only be made up of described test cell 1 and described indexing unit 2, just can realize the object of irritated test.
When using device of the present invention to carry out allergy test, operator first can carry out suitable preparation, such as surface cleaning etc. to test zone (certain area as experimenter's forearm).
Then, operator throws off described teleblem 5 from described test cell 1, and described container 6 is opened, and operator can be observed needle device 7 in each container 6 and/or spongy material 8 and anaphylactogen.If anaphylactogen is liquid or other flowable forms, for reducing the loss of anaphylactogen as far as possible, those skilled in the art can select suitable mode to cover on test zone by container unit, such as, keep vessel port mode upward.Owing to test cell 1 also remaining to the flexible double-sided adhesive material layer 10 of small part, thus test cell 1 can be fixed on test zone.Protecting film on the indexing unit 2 of test cell 1 both sides is also thrown off, and is pressed abd fixed on test zone.
Then, operator is by applying pressure (such as by a stable pressing plate) to container 6 dorsal part of each container unit 3, the needle device 7 carrying anaphylactogen can be thrust within concrete test position (as specific skin surface), like this, the anaphylactogen in each container 6 and/or in spongy material 8 can arrive each concrete test position.
After described test cell 1 acts on a period of time on test zone, operator catches described test cell 1 to compress or fixing described indexing unit 2 simultaneously, test cell 1 is separated with indexing unit 2 along jaggies 11, and makes indexing unit 2 still be retained in assay test zone carrying out irritated test for operator.The experimenter can be observed by operator for the reaction of various anaphylactogen, and carries out record by the corresponding informance on indexing unit 2.After having recorded, described indexing unit 2 can take off from test zone, the test zone of such experimenter would not exist the labelling needing the long period to remove completely.If desired, can by paste or described indexing unit 2 be placed in the documentations such as medical archive by other modes, such as, in case, information of being used as to file or mark.
Although present invention has been description to a certain degree, significantly, under the condition not departing from the spirit and scope of the present invention, can carry out the suitable change of each condition.Be appreciated that and the invention is not restricted to described embodiment, and be attributed to the scope of claim, it comprises the equivalent replacement of described each factor.
Claims (13)
1. the device for allergy test, described device comprises test cell (1) and indexing unit (2), described test cell comprises multiple container unit (3) and the counterdie (4) for being connected described multiple container unit, described container unit comprises the container (6) for holding anaphylactogen, described indexing unit and described test cell adjoin and arrange, it is characterized in that, described container unit also comprises needle device (7), and described needle device is arranged in the bottom interior wall of described container;
Described test cell (1) also comprises the teleblem (5) covered on described container unit (3) and described counterdie (4), for closing described container unit; By using flexible double-sided adhesive material layer (10) by mode mutually bonding with described counterdie (4) for described teleblem (5), described teleblem is covered on described container unit and described counterdie;
Described teleblem (5) is from after described test cell (1) is removed, and at least part of described flexible double-sided adhesive material layer is retained on described test cell, and described test cell can be attached on test zone;
Described indexing unit (2) is fixed on the side of described test cell (1) removably, and at least part of with adhesives towards test zone side of described indexing unit, removes described test cell when making indexing unit be retained on test zone;
Described device is only made up of described test cell and described indexing unit;
The wall shape structure (9) that described container unit (3) also comprises the edge of opening around described container (6) and arranges, and described wall shape structure forms a part for the sidewall of described container.
2. device according to claim 1, is characterized in that, described needle device (7) is arranged to be basically perpendicular to the mode of the bottom interior wall of described container (6).
3. device according to claim 1, is characterized in that, is provided with spongy material (8) in described container (6), and described needle device (7) runs through described spongy material.
4. device according to claim 1, is characterized in that, the top end of the basic edge of opening with described container in the top of described needle device (7) or described wall shape structure at grade.
5. device according to any one of claim 1 to 3, is characterized in that, the cross section of described container (6) is circle, rectangle or square.
6. device according to any one of claim 1 to 3, is characterized in that, the cross section of described container (6) is circular.
7. device according to any one of claim 1 to 3, is characterized in that, described flexible double-sided adhesive material layer not covering container unit, and its thickness is basic equal with the height of described wall shape structure (9).
8. device according to any one of claim 1 to 3, is characterized in that, described flexible double-sided adhesive material layer (10) is for upper and lower surface is through the high molecular polymer of viscosity process or medical proof fabric.
9. device according to any one of claim 1 to 3, is characterized in that, the back side of described counterdie (4) is printed with animal pattern, cartoon pattern or strip cartoon.
10. device according to any one of claim 1 to 3, is characterized in that, indexing unit described at least one is fixed on the side of described test cell along perforation line (11).
11. devices according to any one of claim 1 to 3, is characterized in that, fix an indexing unit two of described test cell relative sides are each.
12. 1 kinds of methods preparing the device according to any one of claim 1 to 11, described preparation method comprises step anaphylactogen injected the step in described container (6) and is covered by described teleblem (5) on described container unit (3) and described counterdie (4), it is characterized in that, the step injected by anaphylactogen in described container is carried out after described teleblem being covered the step on described container unit and described counterdie.
The application of device according to any one of 13. claim 1 to 11 in the product tested for the preparation of allergy.
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201210347939.6A CN102908123B (en) | 2012-09-18 | 2012-09-18 | A kind of device for allergy test and its preparation method and application |
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| Application Number | Priority Date | Filing Date | Title |
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| CN201210347939.6A CN102908123B (en) | 2012-09-18 | 2012-09-18 | A kind of device for allergy test and its preparation method and application |
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| CN102908123A CN102908123A (en) | 2013-02-06 |
| CN102908123B true CN102908123B (en) | 2015-10-28 |
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Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US5104620A (en) * | 1990-07-30 | 1992-04-14 | Wiley Fred R | Disposable allergy skin testing kit |
| US5325864A (en) * | 1990-07-20 | 1994-07-05 | Jan Gerber | Diagnostic testing device for the skin |
| CN202761327U (en) * | 2012-09-18 | 2013-03-06 | 杨智杰 | Device used for allergy test |
Family Cites Families (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| ATE450203T1 (en) * | 2005-02-24 | 2009-12-15 | Schindlbeck Gerhard Dr | DEVICE FOR PERFORMING AN ALLERGY TEST |
| KR101018406B1 (en) * | 2009-10-28 | 2011-02-28 | 김도위 | Tester with needle for diagnosing skin condition of allergen |
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2012
- 2012-09-18 CN CN201210347939.6A patent/CN102908123B/en active Active
Patent Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US5325864A (en) * | 1990-07-20 | 1994-07-05 | Jan Gerber | Diagnostic testing device for the skin |
| US5104620A (en) * | 1990-07-30 | 1992-04-14 | Wiley Fred R | Disposable allergy skin testing kit |
| CN202761327U (en) * | 2012-09-18 | 2013-03-06 | 杨智杰 | Device used for allergy test |
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| Publication number | Publication date |
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| CN102908123A (en) | 2013-02-06 |
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Effective date of registration: 20160706 Address after: 550081 D1 building, Guiyang Tuyun Road, Jinyang hi tech Industrial Development Zone, Guizhou, China Patentee after: Guizhou Witkey Technology Co., Ltd. Address before: 3 unit 4, building 186, 602 Youyi Road, Guizhou, Guiyang 550001, China Patentee before: Yang Zhijie |