CN102908123A - Device for allergy test, preparation method and application of device - Google Patents
Device for allergy test, preparation method and application of device Download PDFInfo
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- CN102908123A CN102908123A CN2012103479396A CN201210347939A CN102908123A CN 102908123 A CN102908123 A CN 102908123A CN 2012103479396 A CN2012103479396 A CN 2012103479396A CN 201210347939 A CN201210347939 A CN 201210347939A CN 102908123 A CN102908123 A CN 102908123A
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- 238000012360 testing method Methods 0.000 title claims abstract description 153
- 206010020751 Hypersensitivity Diseases 0.000 title claims abstract description 18
- 208000026935 allergic disease Diseases 0.000 title claims abstract description 18
- 230000007815 allergy Effects 0.000 title claims abstract description 18
- 238000002360 preparation method Methods 0.000 title claims abstract description 17
- 238000000034 method Methods 0.000 claims abstract description 16
- 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
- 238000007789 sealing Methods 0.000 claims description 19
- 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
- 239000013566 allergen Substances 0.000 abstract 1
- 210000003491 skin Anatomy 0.000 description 18
- 239000010408 film Substances 0.000 description 10
- 238000007731 hot pressing Methods 0.000 description 10
- 239000007788 liquid Substances 0.000 description 8
- 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
- 235000018185 Betula X alpestris Nutrition 0.000 description 4
- 235000018212 Betula X uliginosa Nutrition 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
- 238000003825 pressing Methods 0.000 description 4
- 230000000694 effects Effects 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
- 238000012545 processing Methods 0.000 description 3
- 238000006748 scratching Methods 0.000 description 3
- 230000002393 scratching effect Effects 0.000 description 3
- 208000003443 Unconsciousness Diseases 0.000 description 2
- 239000013543 active substance Substances 0.000 description 2
- 239000002313 adhesive film Substances 0.000 description 2
- 230000002411 adverse Effects 0.000 description 2
- 238000003556 assay Methods 0.000 description 2
- 230000008901 benefit Effects 0.000 description 2
- 239000000470 constituent Substances 0.000 description 2
- 210000002615 epidermis Anatomy 0.000 description 2
- 238000011156 evaluation Methods 0.000 description 2
- 239000006261 foam material Substances 0.000 description 2
- 239000003365 glass fiber Substances 0.000 description 2
- 238000004519 manufacturing process Methods 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
- 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
- 230000002950 deficient Effects 0.000 description 1
- 208000002925 dental caries Diseases 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
- 238000004321 preservation Methods 0.000 description 1
- 230000002035 prolonged effect Effects 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
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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)
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- Biophysics (AREA)
- Investigating Or Analysing Biological Materials (AREA)
Abstract
The invention provides a device for an allergy test. The device comprises a test unit and a mark unit; the test unit comprises a plurality of container units and a bottom film connected with the plurality of container units; each container unit comprises a container for containing allergen; the mark unit and the test unit are adjacently arranged; each container unit also comprises a needle-shaped device, and the needle-shaped device is arranged at a bottom inner wall of the container. A method for preparing the device and application of the device in preparation of a product for the allergy test are also provided by the invention.
Description
Technical field
The present invention relates to a kind of device for the allergy test, and the preparation method of this device, and the application of this device in the product of testing for the preparation of allergy.
Background technology
Patent EP1695666B1 discloses a kind of device be used to carrying out irritated test, and this installs with a container unit and a cover plate unit.By removing its coverlay, can effectively be fixed to container unit on the cover plate unit, between cover plate unit and the container unit the situation that anaphylactogen spills or obscures can not appear.Cover plate unit be placed to (such as) on experimenter's forearm after, by cutting the instrument of drawing or the instrument of pinking cuts by the through hole on the cover plate instrument and draws or injured skin, then tear the closing membrane of closed container off and container unit be turned on the cover plate unit.The anaphylactogen that is arranged in container arrives the skin position that is damaged by through hole, so just can observe the experimenter to the reaction of various anaphylactogens.
But, this patent is mainly finished by through hole corresponding with container unit on the cover plate unit and continuous cut groove, this just need to be divided into two steps to the preparation of test zone and test operation and carry out, not only increased the complexity of test set, also increase operating procedure, prolonged the operating time.Simultaneously, if produce disposable skin irritation straight, that do not stop by continuous cut groove, then this continuous cut groove and the container unit adhesion after might cause the phenomenon of leakage between the different vessels.
The container unit of this patent is by one deck adhesive film or have at least the design of adhesive film to finish the adhesion of itself and cover plate unit in the part.This operation relates to container unit Rotate 180 °, thereby if anaphylactogen liquid is not spilt in switching process, then need to be fixed on the container unit to spongy material and the addition of control liquid, perhaps need to keep when rotated the container unit level, this design can increase the complexity of device and operating process.
In addition, the disclosed container chamber of this patent is made of aluminum closing membrane and counterdie, seals by hot pressing with counterdie behind the spongy material of aluminum closing membrane in anaphylactogen adding container chamber.At this moment, the heat in the hot-press sealed process can cause damage to anaphylactogen.If reduce to greatest extent the heat of hot pressing to the damage of anaphylactogen; then the sealing of container chamber, closing membrane are thrown off all many-sides such as the seriality of process and forming shape and will be restricted; this also is unfavorable for the protection to anaphylactogen and spongy material, and may affect actual operating experience.
It is simpler also to need at present to seek a kind of structure, device more convenient to operate and that test for allergy efficiently.
Summary of the invention
Therefore, the object of the invention is to overcome the existing complex structure of irritated testing equipment of the prior art, the lengthy and tedious defective of operation, a kind of device that is used for fast irritated test simple in structure, easy to operate is provided, and the method for preparing this device, and the application of this device in the product of testing for the preparation of allergy.
The invention provides a kind of device for the allergy test, described device comprises test cell 1 and indexing unit 2, described test cell comprises a plurality of container units 3 and the counterdie 4 that is used to connect described a plurality of container units, described container unit 3 comprises be used to the container 6 that holds anaphylactogen, described indexing unit 2 arranges with described test cell 1 adjacency, wherein, described container unit also comprises needle-like device 7, and described needle-like device is arranged on the bottom interior wall of described container.
Described test cell 1 can be designed as the structure of flat, for example can be a kind ofly to have a plurality of grooves and other parts are the structure on plane substantially, in addition, described test cell can use this area material commonly used, but be preferably frivolous, pliable and tough material, for example polymer is preferably plastics, can match with test zone (such as the experimenter's forearm) better thus.
For realizing purpose 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 slightly contacting; then can avoid described needle-like device to puncture described teleblem, thereby the 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-like device can substitute the needle-like cut device that is used for scratching top layer skin in the prior art.When practical operation, exert pressure by (for example by a stable pressing plate) by the container dorsal part to each container unit, the needle-like device that carries anaphylactogen can be thrust in the concrete test position (such as epiderm skin) in the test zone.Described needle-like device can be a kind of sharps, for example can be the larger sharps of mechanical strength (such as the metal sharps), as sharps, fibre bundle wherein relatively is suitable for the operation of dry active substance also can to use high rigidity fiber or fibre bundle (such as glass fibre or hard and sharp-pointed plastic optical fibre).In a container, described needle-like device can be one, also can be two or more.Under the prerequisite of the purpose that can realize thrusting top layer skin, described needle-like device can be arranged on the bottom interior wall of described container in any way, for example the bottom interior wall angulation of described needle-like device and container can be between 0 ~ 90 °, described needle-like device is preferably perpendicular to the bottom interior wall of described container, again for example, if the material of container inner wall is polymer, then can make by the mode that heats this polymer described needle-like device and bottom interior wall inter-adhesive, with fixing described needle-like device, perhaps can the circulus identical with the container bottom size be set in described needle-like bottom of device, mode by physics with described needle-like device card in the bottom of bowl, etc.
Described anaphylactogen can be liquid, also can be arranged in the described container with the form of solid, gel, paste or lyophilizing shape.When the needle-like device is designed to sharps with lyophilizing shape anaphylactogen, can not need in the described container for preserving and the fixing spongy material 8 of anaphylactogen.
According to device of the present invention, wherein, described needle-like device 7 can be in the mode of the bottom interior wall that is basically perpendicular to described container 6 and is arranged.
According to device of the present invention, wherein, can be provided with spongy material 8 in the described container 6, and described needle-like device 7 runs through described spongy material.Described spongy material can be this areas such as spongiform high molecular foam material, spongiform non-woven cloth fabric material or sponge materials commonly used.The liquid anaphylactogen can be fixed and preserve to described spongy material better, and in the destroyed situation of container tightness, can slow down the damage of anaphylactogen and overflow.
According to device of the present invention, wherein, described container unit 3 can also comprise the wall shape structure 9 that arranges around the edge of opening of described container 6, and described wall shape structure forms the part of the sidewall of described container.As preferably, the top of described needle-like device 7 can be 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 be separated different anaphylactogens effectively.The height that those skilled in the art can be by adjusting described wall shape structure and the deformation extent of described container unit are to regulate the degree of depth of thrusting of needle-like device.The top of considering the needle-like device as the opening of container as described in being higher than or as described in during the top of wall shape structure, may cause adverse effect to teleblem, and as the opening of container as described in being lower than or as described in during the top of wall shape structure, then may strengthen the difficulty of thrusting of needle-like device, therefore preferably, the top of described needle-like device can be substantially and the top end of the edge of opening of described container or described wall shape structure at grade.Described wall shape structure can by particularly advantageous mode, be fixed when covering teleblem hot pressing on the container unit.
According to device of the present invention, wherein, the cross section of described container 6 can be circle, rectangle or square.Can be preferably circle.
According to device of the present invention, wherein, described test cell 1 can also comprise the teleblem 5 that covers on described container unit 3 and the described counterdie 4, is used for sealing described container unit.So, when described teleblem is combined with wall shape structure, can improve better the sealing of container unit, can also prevent from effectively that the needle-like device is unconscious in transportation or operation to open described container.As preferably, can by using flexible double-sided adhesive material layer 10 with the mutual bonding mode of described teleblem 5 and described counterdie 4, described teleblem be covered on described container unit and the described counterdie.As more preferably, described flexible double-sided adhesive material layer is the covering container unit not, and its thickness equates with the height of described wall shape structure 9 substantially.When using the flexible double-sided adhesive material layer that teleblem and counterdie is mutual when bonding, because the thickness of flexible double-sided adhesive material layer and the height of wall shape structure are about equally, and it is the covering container unit not, thereby can fill the teleblem that causes because of wall shape structure and the space between the counterdie, effective like this edge of opening (or upper end-face edge of wall shape structure) of having avoided teleblem only to be pasted on container unit, make bonding more firm between two films, open more continuous.
According to device of the present invention, wherein, described flexible double-sided adhesive material layer 10 can be high molecular polymer or the medical proof fabric of upper and lower surface through the viscosity processing.The utilization of this material can so that seriality is more arranged when opening between teleblem and the counterdie, prevent from opening the apparatus vibration that produces when pasting two inhomogeneous film.As further preferred, after described teleblem 5 is removed from described test cell 1, at least part of described flexible double-sided adhesive material layer will be retained on the described test cell, and described test cell can be attached on the test zone.For ease of opening, described teleblem can form in different directions outstanding shape or have different edges from flexible double-sided adhesive material layer and counterdie.For example the part of described teleblem and/or described flexible double-sided adhesive material layer can surpass the edge of described counterdie, so that be easy in use open described teleblem, and/or be easy to remove described test cell to stay 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 can be eliminated the child to the feared state of mind of allergy test in test cell is attached to the process of test zone.In addition, the shape of container also can be designed to various shape, color or quantity in the container unit, all can adjust according to child's needs.
According to device of the present invention, wherein, described indexing unit 2 is fixed on the side of described test cell 1 removably, and described indexing unit is at least part of with adhesives towards test zone one side, indexing unit is retained in the situation on the test zone removes described test cell.As preferably, at least one described indexing unit can be fixed on the side of described test cell along perforation line 11.As preferably, can each fix an indexing unit at two of described test cell relative sides.Be antipollution appearance, the adhesive material on the indexing unit can be covered by the protecting film that can take off.
According to device of the present invention, wherein, described device only is comprised of described test cell 1 and described indexing unit 2.
The present invention also provides a kind of method for preparing device of the present invention, described preparation method comprises to be injected anaphylactogen the step in the described container 6 and described teleblem 5 is covered step on described container unit 3 and the counterdie 4, wherein, the step of anaphylactogen being injected in the described container is carried out after the step that described teleblem is covered on described container unit and the described counterdie.When described teleblem is that mode by hot pressing covers and when sealing described container, method of the present invention can be avoided the damage that heat causes anaphylactogen in the hot pressing.Owing to sealing between teleblem and the container before the injection anaphylactogen, thereby those skilled in the art can be by the method for injection, for example penetrate described teleblem or described chamber wall injects container with anaphylactogen, perhaps can facing in the scope of vessel port through hole be set at described teleblem, this through hole preferably is 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 the ultraviolet sealing tech is sealed related hole.In the situation of having used spongy material, those skilled in the art should know, usually after spongy material being arranged in the described container, carry out again teleblem is covered step on described container unit (namely covering on the opening of described container or on the described wall shape structure) and the described counterdie.
The present invention also provides the application of device of the present invention in the product of testing for the preparation of allergy.
Specifically, the present invention has designed a kind of device for the allergy test, and this device is comprised of test cell and indexing unit.Test cell comprises a plurality of container units and the counterdie that is connected described a plurality of container units, the container unit band is useful on the container that holds anaphylactogen, the needle-like device is integrated on the aluminum film of container unit bottom, test cell also comprises the teleblem that covers on described container unit and the counterdie, and band is useful on the aperture of filling 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 the counterdie.After the step of filling anaphylactogen, the filling hole on the teleblem will be by ultrasonic or ultraviolet sealing tech sealing.
The advantage of this device is: only by an operating procedure (namely removing teleblem), just can be fixed firmly to whole checkout gear the surface of test skin.Do not need extra device that skin is carried out pretreatment, but by being integrated in the needle-like device of container unit, finish the skin pretreatment through unified pressing.The situation that spills or obscure that can not occur owing to unnecessary device and operation anaphylactogen between the container unit.Because just add anaphylactogen in the preparation later stage, this device can be avoided the damage that heat causes anaphylactogen in the hot pressing closed process effectively.In addition, through after enough action time, whole test cell can take off and clear from irritated test zone.At this moment indexing unit will separate 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 be separated different anaphylactogens effectively, increases the sealing of test section, and having avoided between the anaphylactogen of different test positions affecting irritated test result because of mutual pollution, thereby has improved the accuracy of irritated test.
2. device of the present invention can be fixed on the zone to be measured by the simplest mode, and effectively anaphylactogen is delivered to the tested person zone by minimum step.Specifically, by the modifying device among the present invention, the operator only need throw off teleblem and just test cell and indexing unit can be fixed to and carry out the allergy test on the test zone, thereby with respect to prior art, the present invention has simplified operating procedure, reduce operation easier, also reduced simultaneously to the set-up mode of spongy material with to anaphylactogen adding quantitative limitation, and then be conducive to carry out more convenient allergy test.
3. the design of many kinds of needle-like devices is so that this device is more effective to the pretreatment of epidermis, and by increasing the epidermis processing area, this device can effectively reduce the anaphylactogen working concentration.Thereby, when not affecting detection accuracy and stability, further reduce production costs.
4. this device will further increase the sealing of each container unit and tested skin by the use to wall shape structure.What form when independently wall shape structure also helps fixed press needle-like device thrusts the degree of depth.In transportation, storage, this wall shape structure is conducive to protect container unit not to be subjected to outside destroy.
5. the preparation method of apparatus of the present invention can reduce the damage to anaphylactogen effectively.With respect to prior art, the present invention improves the preparation method of device, it is not deferred to this area and usually inserts first the method that anaphylactogen seals again, insert again anaphylactogen but seal first off the beaten trackly, heat is to the damage of anaphylactogen in the time of can reducing or eliminating the hot pressing teleblem like this, thereby improved the degree of accuracy of irritated test.
Description of drawings
Below, describe by reference to the accompanying drawings embodiment of the present invention in detail, wherein:
Fig. 1 shows the top view of device of the present invention, and the anaphylactogen titles such as " hazel " among the figure, " birch " only are schematically record, and the anaphylactogen that should not be construed as this device carries out any restriction;
Fig. 2 shows device of the present invention along the cutaway view of A-A line;
Fig. 3 shows the top view of device of the present invention after opening teleblem, and wherein the figure right side is depicted as teleblem, and the anaphylactogen titles such as " hazel " among the figure, " birch " only are schematically record, and the anaphylactogen that should not be construed as this device carries out any restriction;
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 the part teleblem, and the anaphylactogen titles such as " hazel " among the figure, " birch " only are schematically record, and the anaphylactogen that should not be construed as this device carries out any restriction;
Fig. 7 shows the schematic top plan view of device of the present invention when removing part (upper left corner) counterdie and test cell, the anaphylactogen titles such as " hazel " among the figure, " birch " only are schematically record, and the anaphylactogen that should not be construed as this device carries out any restriction.
The specific embodiment
Further specify the present invention below by specific embodiment, still, should be understood to, these embodiment are only used for the more detailed usefulness that specifically describes, and should not be construed as for limiting in any form the present invention.
The device that is used for irritated test among the present invention comprises test cell 1 and indexing unit 2.Described test cell 1 can be designed as the structure of flat, for example can be a kind ofly to have a plurality of grooves and other parts are the structure on plane substantially, in addition, described test cell can use this area material commonly used, but be preferably frivolous, pliable and tough material, for example polymer is preferably plastics, can match with test zone (such as the experimenter's forearm) better thus.But for realizing purpose of the present invention, those skilled in the art know; described test cell 1 constituent material own should be enough firm; to avoid when slightly contacting, producing distortion, then can avoid described needle-like device 7 to puncture described teleblem 5, thereby the 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 can use the cavity thin film as test cell, the cavity thin film comprises two-layer parallel thin film, and they are with network-like mutually bonding, thereby forms the cavity of many mutual sealings, and these cavitys can be used as container.Wherein, the thin film of use is thinner and pliable and tough, and before double-layer films was mutually bonding, wherein thin film was placed in the forming bottom plate with corresponding recesses, and the anaphylactogen of various liquid can be packed in the later stage, and these are on the thin film in the groove.
Described indexing unit 2 arranges with described test cell 1 adjacency.For example, described indexing unit 2 is fixed on the side of described test cell 1 removably, and described indexing unit 2 is at least part of with adhesive material towards test zone one side, indexing unit 2 is retained in the situation on the test zone removes described test cell 1.After test cell 1 is removed from test zone, at least one indexing unit 2 that is similar to adhesive tape is retained near the test zone, like this, according to indexing unit 2 information that provides of test zone one side dorsad, can clearly a certain concrete test position in a certain anaphylactogen and the test zone be mapped, so that assay is carried out in test to allergy.Correspondingly, the corresponding informance between anaphylactogen and a certain concrete test position is no longer by the form of color or paster, but is applied directly on the skin, and can successfully take off from skin after irritated test analysis evaluation finishes.As preferably, described indexing unit 2 can carry out along perforation line 11 dismountable fixing, and the benefit of this design is that described test cell 1 and described indexing unit 2 can be produced in same production stage.Be antipollution appearance, the adhesive material on the indexing unit 2 can be covered by the protecting film that can take off.For guaranteeing as far as possible to be attached to reliably on the test zone, indexing unit 2 can be all with adhesive material towards a side of skin.As preferably, can each fix an indexing unit 2 at two of described test cell 1 relative sides, can provide more corresponding informance like this, and in the more situation of anaphylactogen kind, can have better indicative function.
Described test cell 1 and indexing unit 2 have toughness and can be crooked, can adapt with warp architecture or the domes of skin surface.For example, described test cell 1 and indexing unit 2 can be made by thin plastic layer, can increase coating by appropriate ways in case of necessity.
Described test cell 1 comprises a plurality of container units 3, and container unit 3 comprises be used to the container 6 that holds anaphylactogen.Described container unit 3 also can be fixed on the described test cell 1 removably, be that 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 the test zone, perhaps container unit 3 and indexing unit 2 can together continue to be attached on the test zone, can remove container unit 3 through behind the certain hour, then carry out irritated testing evaluation by the corresponding informance on the indexing unit 2.
Described container unit 3 can be arranged on the described test cell 1 in common mode, for example can be the two row's container units 3 that are 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 child to the feared state of mind of allergy test.In addition, described container 6 can be designed as arbitrary shape, color and quantity, and for example the cross section of described container 6 can for circle, rectangle or square, can be preferably circle.
Described container unit 3 also comprises needle-like device 7, and described needle-like device 7 is arranged on the bottom interior wall of described container 6.Described needle-like device 7 can substitute the needle-like cut device that is used for scratching top layer skin in the prior art, when reality is used, exert pressure by (for example by a stable pressing plate) by container 6 dorsal parts to each container unit 3, the needle-like device 7 that carries anaphylactogen can be thrust in the concrete test position (such as skin surface) in the test zone.Described needle-like device 7 can be a kind of sharps, for example can be the larger sharps of mechanical strength (such as the metal sharps), as sharps, fibre bundle wherein relatively is suitable for the operation of dry active substance also 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-like device 7 can be one, also can be two or more.Under the prerequisite of the purpose that can realize scratching top layer skin, described needle-like device 7 can be arranged on the bottom interior wall of described container 6 in any way, for example the bottom interior wall angulation of described needle-like device 7 and container 6 can be between 0 ~ 90 °, as needle-like device 7 can perpendicular to as described in the bottom interior wall of container 6, again for example, if the material of container 6 inwalls is polymer, then can make by the mode that heats this polymer described needle-like device and bottom interior wall inter-adhesive, with fixing described needle-like device 7, perhaps the circulus identical with container 6 bottoms size can be set in described needle-like device 7 bottoms, mode by physics is stuck in the bottom of bowl with described needle-like device 7, etc.
Described anaphylactogen can be liquid, also can be arranged on the form of solid, gel, paste or lyophilizing in the described container.When the needle-like device is designed to sharps with lyophilizing formula anaphylactogen, can not need spongy material 8 in the described container.
Edge of opening at container can arrange wall shape structure 9, and described wall shape structure 9 forms the part of the sidewall of described container 6.As preferably, the top of described needle-like device 7 can be 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 be separated the anaphylactogen in each different vessels effectively, and described wall shape structure 9 can contact with skin around a concrete test position in the test zone, thereby can also effectively mutually seal each concrete test position, the anaphylactogen that belongs to a concrete test position can not arrive another concrete test position.In addition, the height that those skilled in the art can be by adjusting described wall shape structure 9 and the deformation extent of described container unit 3 are to regulate the degree of depth of thrusting of needle-like device.The top of considering needle-like device 7 as the opening of container 6 as described in being higher than or as described in during the top of wall shape structure 9, may cause adverse effect to teleblem, and as the opening of container 6 as described in being lower than or as described in during the top of wall shape structure 9, then may strengthen the difficulty of thrusting of needle-like device 7, therefore preferably, the top of described needle-like device 7 can be substantially and 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 by particularly advantageous mode, be fixed on the counterdie 4 when the preparation container chamber, or fix when covering teleblem 5 hot pressing on the container unit 3.
Can be provided with spongy material 8 in the described container, and described needle-like device 7 runs through described spongy material 8.Spongy material 8 can be this areas such as spongiform high molecular foam material, spongiform non-woven cloth fabric material or sponge materials commonly used.The liquid anaphylactogen can be fixed and preserve to described spongy material 8 better, and in the destroyed situation of container tightness, can slow down the damage of anaphylactogen and overflow.
Described test cell 1 can also comprise the teleblem 5 that covers on described container unit 3 and the described counterdie 4, is used for sealing described container unit 3, makes the anaphylactogen in container and/or the spongy material long preservation also be used for irritated purpose of testing.When described teleblem 5 is combined with wall shape structure 9, can improve better the sealing of container unit 3, can also prevent from effectively that needle-like device 7 is unconscious in transportation or operation to open described container 6.As preferably, can use flexible double-sided adhesive material layer 10 mutually bonding between described teleblem 5 and the counterdie 4, so that teleblem 5 is covered on described container unit 3 and the counterdie 4.
Described flexible double-sided adhesive material layer 10 can be high molecular polymer or the medical proof fabric of upper and lower surface through the viscosity processing.The utilization of this material can so that seriality is more arranged when opening between teleblem 5 and the counterdie 4, prevent from opening the apparatus vibration that produces when pasting two inhomogeneous film.As further preferred, after described teleblem 5 was removed from described test cell 1, at least part of described flexible double-sided adhesive material layer 10 was retained on the described test cell 1, and described test cell 1 can be attached on the test zone.For ease of opening, described teleblem 5 can form in different directions outstanding shape or have different edges from flexible double-sided adhesive material layer 10 and counterdie 4.For example the part of described teleblem 5 and/or described flexible double-sided adhesive material layer 10 can surpass the edge of described counterdie 4, so that be easy in use open described teleblem 5, and/or be easy to remove described test cell 1 to stay indexing unit 2.
When described teleblem 5 is that mode by hot pressing covers and when sealing described container 6, the present invention prepares in the method for described device, anaphylactogen will be injected in the described container chamber after described teleblem 5 covers on described container unit 3 and the counterdie 4, can avoid the damage that heat causes anaphylactogen in the hot pressing like this.Owing to sealing between teleblem 5 and the container 6 before the injection anaphylactogen, thereby those skilled in the art can be by the method for injection, for example penetrate described teleblem or described chamber wall injects container with anaphylactogen, perhaps can facing in the scope of vessel port through hole be set at described teleblem, this through hole preferably is 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 the ultraviolet sealing tech is sealed related hole.In the situation of having used spongy material, those skilled in the art should know, usually after spongy material being arranged in the described container, carry out again teleblem is covered on the described container unit step of (namely covering on the opening of described container or on the described wall shape structure).
Device of the present invention can only be comprised of described test cell 1 and described indexing unit 2, just can realize the purpose of irritated test.
Using device of the present invention to carry out allergy when testing, the operator can carry out suitable preparation to test zone (such as the certain area of experimenter's forearm) first, such as cleaning surfaces etc.
Then, the operator throws off described teleblem 5 from described test cell 1, and described container 6 is opened, and the operator can be observed needle-like device 7 and/or spongy material 8 and the anaphylactogen in each container 6.If anaphylactogen is liquid or other flowable forms, for reducing as far as possible the loss of anaphylactogen, those skilled in the art can select suitable mode that container unit is covered on the test zone, for example keep vessel port mode up.Owing to also remain to the flexible double-sided adhesive material layer 10 of small part on the test cell 1, thereby test cell 1 can be fixed on the 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 the test zone.
Then, the operator is by container 6 dorsal parts to each container unit 3 exert pressure (for example by a stable pressing plate), the needle-like device 7 that carries anaphylactogen can be thrust within the concrete test position (such as specific skin surface), like this, in each container 6 and/or the anaphylactogen in the spongy material 8 can arrive each concrete test position.
Described test cell 1 is after test zone effect a period of time, the operator catches described test cell 1 to compress simultaneously or fixing described indexing unit 2, test cell 1 is separated with indexing unit 2 along jaggies 11, and make indexing unit 2 still be retained in the assay that carries out irritated test on the test zone for the operator.The experimenter can be observed by the operator for the reaction of various anaphylactogens, and carries out record by the corresponding informance on the indexing unit 2.After record was finished, described indexing unit 2 can take off from test zone, just can not have like this labelling that needs the long period to remove fully on the experimenter's the test zone.In case of necessity, can be by pasting or other modes be placed into described indexing unit 2 in the documentation such as medical archive, for example in the case, is used as file or the information of marking.
Although the present invention has carried out description to a certain degree, significantly, under the condition that does not break away from the spirit and scope of the present invention, can the suitable variation of each condition of carrying out.Be appreciated that to the invention is not restricted to described embodiment, and be attributed to the scope of claim, it comprises the replacement that is equal to of described each factor.
Claims (12)
1. one kind is used for the irritated device of testing, described device comprises test cell (1) and indexing unit (2), described test cell comprises a plurality of container units (3) and the counterdie that is used to connect described a plurality of container units (4), described container unit comprises be used to the container that holds anaphylactogen (6), described indexing unit and described test cell are in abutting connection with setting, it is characterized in that described container unit also comprises needle-like device (7), described needle-like device is arranged on the bottom interior wall of described container.
2. device according to claim 1 is characterized in that, described needle-like device (7) is in the mode of the bottom interior wall that is basically perpendicular to described container (6) and arrange.
3. device according to claim 1 is characterized in that, is provided with spongy material (8) in the described container (6), and described needle-like device (7) runs through described spongy material.
4. each described device in 3 according to claim 1, it is characterized in that, described container unit (3) also comprises the wall shape structure (9) that arranges around the edge of opening of described container (6), and described wall shape structure forms the part of the sidewall of described container; Preferably, the top of described needle-like device (7) basic with described container edge of opening or the top end of described wall shape structure at grade.
5. each described device in 4 according to claim 1 is characterized in that, the cross section of described container (6) is circular, rectangle or square; Be preferably circle.
6. each described device in 5 according to claim 1 is characterized in that described test cell (1) also comprises the teleblem (5) that covers on described container unit (3) and the described counterdie (4), is used for sealing described container unit; Preferably, by using flexible double-sided adhesive material layer (10) mode that described teleblem (5) is mutual bonding with described counterdie (4), described teleblem is covered on described container unit and the described counterdie; More preferably, described flexible double-sided adhesive material layer is the covering container unit not, and its thickness equates with the height of described wall shape structure (9) substantially.
7. each described device in 6 according to claim 1 is characterized in that described flexible double-sided adhesive material layer (10) can be high molecular polymer or the medical proof fabric that process through viscosity on upper and lower surface; Preferably, after described teleblem (5) was removed from described test cell (1), at least part of described flexible double-sided adhesive material layer was retained on the described test cell, and described test cell can be attached on the test zone.
8. each described device in 7 according to claim 1 is characterized in that the back side of described counterdie (4) is printed with animal pattern, cartoon pattern or strip cartoon.
9. each described device in 8 according to claim 1, it is characterized in that, described indexing unit (2) is fixed on the side of described test cell (1) removably, and described indexing unit is at least part of with adhesives towards test zone one side, indexing unit is retained in the situation on the test zone removes described test cell; Preferably, at least one described indexing unit is fixed on the side of described test cell along perforation line (11); More preferably, each fixes an indexing unit at two of described test cell relative sides.
10. each described device in 9 according to claim 1 is characterized in that described device only is comprised of described test cell and described indexing unit.
11. method for preparing each described device in the claim 1 to 10, described preparation method comprises to be injected anaphylactogen the step in the described container (6) and described teleblem (5) is covered step on described container unit (3) and the described counterdie (4), it is characterized in that, the step that anaphylactogen injects in the described container is carried out after the step that described teleblem is covered on described container unit and the described counterdie.
12. the application of each described described device in the product of testing for the preparation of allergy in the claim 1 to 10.
Priority Applications (1)
| 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 |
|---|---|---|---|
| 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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| Publication Number | Publication Date |
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| CN102908123A true CN102908123A (en) | 2013-02-06 |
| CN102908123B CN102908123B (en) | 2015-10-28 |
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| CN201210347939.6A Active 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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Citations (5)
| 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 |
| US20090118638A1 (en) * | 2005-02-24 | 2009-05-07 | Gerhard Schindlbeck | Device for Performing an Allergy Test |
| KR101018406B1 (en) * | 2009-10-28 | 2011-02-28 | 김도위 | Tester with needle for diagnosing skin condition of allergen |
| CN202761327U (en) * | 2012-09-18 | 2013-03-06 | 杨智杰 | Device used for allergy test |
-
2012
- 2012-09-18 CN CN201210347939.6A patent/CN102908123B/en active Active
Patent Citations (5)
| 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 |
| US20090118638A1 (en) * | 2005-02-24 | 2009-05-07 | Gerhard Schindlbeck | Device for Performing an Allergy Test |
| KR101018406B1 (en) * | 2009-10-28 | 2011-02-28 | 김도위 | Tester with needle for diagnosing skin condition of allergen |
| CN202761327U (en) * | 2012-09-18 | 2013-03-06 | 杨智杰 | Device used for allergy test |
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| Publication number | Publication date |
|---|---|
| CN102908123B (en) | 2015-10-28 |
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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 |