WO2011053018A2 - Skin diagnosis tester having a needle for allergen identification - Google Patents

Skin diagnosis tester having a needle for allergen identification Download PDF

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Publication number
WO2011053018A2
WO2011053018A2 PCT/KR2010/007481 KR2010007481W WO2011053018A2 WO 2011053018 A2 WO2011053018 A2 WO 2011053018A2 KR 2010007481 W KR2010007481 W KR 2010007481W WO 2011053018 A2 WO2011053018 A2 WO 2011053018A2
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WO
WIPO (PCT)
Prior art keywords
needle
skin
diagnostic
sheet
compartment
Prior art date
Application number
PCT/KR2010/007481
Other languages
French (fr)
Korean (ko)
Other versions
WO2011053018A3 (en
Inventor
김도위
김진우
Original Assignee
Kim Do We
Kim Jin Woo
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Filing date
Publication date
Application filed by Kim Do We, Kim Jin Woo filed Critical Kim Do We
Publication of WO2011053018A2 publication Critical patent/WO2011053018A2/en
Publication of WO2011053018A3 publication Critical patent/WO2011053018A3/en

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B10/00—Instruments for taking body samples for diagnostic purposes; Other methods or instruments for diagnosis, e.g. for vaccination diagnosis, sex determination or ovulation-period determination; Throat striking implements
    • A61B10/02—Instruments for taking cell samples or for biopsy
    • A61B10/0233—Pointed or sharp biopsy instruments
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/32—Surgical cutting instruments
    • A61B17/3209—Incision instruments
    • A61B17/32093—Incision instruments for skin incisions
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M37/00—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin
    • A61M37/0015—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin by using microneedles
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B10/00—Instruments for taking body samples for diagnostic purposes; Other methods or instruments for diagnosis, e.g. for vaccination diagnosis, sex determination or 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
    • A61B17/20—Surgical instruments, devices or methods for vaccinating or cleaning the skin previous to the vaccination
    • A61B17/205—Vaccinating by means of needles or other puncturing devices
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M37/00—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10S—TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10S436/00—Chemistry: analytical and immunological testing
    • Y10S436/811—Test for named disease, body condition or organ function

Definitions

  • the present invention relates to a skin diagnostic tester for diagnosing allergens, and more particularly to a needle-type skin diagnostic tester for diagnosing allergens for accurate reading of results.
  • the skin test is used as the most basic diagnostic method to search for allergens of allergic diseases, and it is widely used to search for allergens in a non-invasive way.
  • Allergy refers to hypersensitivity caused by immunological mechanisms and is mediated by antibodies or cells.
  • a person sensitized to an allergen produces a specific immunoglobulin E antibody (IgE) that reacts with the allergen.
  • IgE immunoglobulin E antibody
  • This specific antibody is bound to the surface of mast cells that spread throughout our body.
  • allergens enter through the skin during skin tests, they bind to the allergens and release various chemical media such as histamine from mast cells.
  • Various secreted chemical media cause immediate swelling and erythema reactions by actions such as vasodilation and increased permeability. This response peaks 15 to 20 minutes after the test. At this time, the size of the swelling and redness is measured with a ruler, and when the size of the swelling is 3 mm or more, it is regarded as a sensitized state.
  • a long time interval between the first reagent drop time and the last reagent drop time may cause a problem in that the time error is increased when reading the result.
  • a dropper for reagent dropping and a syringe needle for skin irritation should be prepared for each reagent type, and reagents are required when dropping reagents on the skin with a dropper. In many cases, the above-mentioned amount is dipped, and there is a problem that an expensive reagent is wasted.
  • the present invention has been proposed to solve the above problems of the conventionally proposed methods, and includes various types of diagnostic reagents used in skin reaction tests and needles for skin irritation, thereby reducing the time error to obtain accurate results. It is an object of the present invention to provide a needle-type skin diagnostic tester for diagnosing allergens that can be read and can reduce costs by reducing waste of instruments and reagents used in skin reaction tests.
  • a needle-type skin diagnostic tester for allergen diagnosis a needle-type skin diagnostic tester for allergen diagnosis
  • a diagnostic sheet attached to the skin having a compartment accommodating the diagnostic aid
  • It is characterized in that it comprises a wound-forming sheet is provided with a needle to contact the diagnostic sheet to burst the compartment, the diagnostic aid therein is deposited on the skin and wound on the skin to cause skin irritation.
  • the wound sheet is.
  • the needle may be rotatably coupled to the diagnostic sheet such that the needle ruptures the compartment and damages the skin.
  • the diagnostic sheet Preferably, the diagnostic sheet,
  • An adhesive layer disposed on an upper portion of the compartment and coated with an adhesive on an edge of the compartment;
  • a cover layer detachably attached to an upper portion of the adhesive layer may be further provided to protect the adhesive layer.
  • the wound sheet is,
  • a cover member detachably attached to an upper portion of the wound sheet may be further provided to protect the needle.
  • the needle Preferably, the needle, the needle, and
  • It may be composed of a needle body that is attached to one surface of the wound sheet to invade the skin to burst the compartment and cause skin irritation is 0.05 to 1.5mm.
  • the needle Preferably, the needle, the needle, and
  • It may consist of microneedles.
  • the compartment is provided with a plurality, so that each can accommodate different diagnostic aids,
  • the needle may be provided in plural numbers corresponding to the plurality of compartments, respectively, so as to burst the plurality of compartments and cause skin irritation.
  • the diagnostic aid More preferably, the diagnostic aid,
  • House dust mites, pollen, animal hair, food, fungi, insects, allergens solutions of drugs and metals, a positive control of the histamine solution, a negative control of the antigen diluent may be included.
  • a needle-type skin diagnostic tester for diagnosing allergens is provided with various types of diagnostic reagents used for skin reaction tests and needles for skin stimulation, thereby reducing accurate time readings.
  • the cost can be reduced by reducing the waste of instruments and reagents used in skin reaction tests.
  • FIG. 1 is a view showing a state of use of the needle-type skin diagnostic tester for diagnosing allergens according to an embodiment of the present invention.
  • Figure 2 is a perspective view of a needle-type skin diagnostic tester for allergen diagnosis according to an embodiment of the present invention.
  • Figure 3 is a perspective view of a needle-type skin diagnostic tester for diagnosing allergens according to another embodiment of the present invention.
  • Figure 4 is a perspective view of the folded state of the diagnostic sheet and the wound sheet of the needle-type skin diagnostic tester for diagnosing allergens according to another embodiment of the present invention.
  • FIG. 5 is an enlarged cross-sectional view of a portion A of FIG. 2.
  • FIG. 6 is an enlarged cross-sectional view of a portion B of FIG. 2.
  • Figure 7 is a cross-sectional view of the folded state of the diagnostic sheet and the wound sheet of the needle-type skin diagnostic tester for diagnosing allergens according to another embodiment of the present invention.
  • compartment 220 diagnostic aid
  • adhesion layer 240 cover layer
  • the needle-type skin diagnostic tester 100 for diagnosing allergens according to an embodiment of the present invention may be used for a skin reaction test, which is a test for identifying IgE antibodies against specific allergens.
  • the test antigen solution, the positive control solution and the negative control solution are instilled into the forearm or the forearm of the arm, and then the needle is irritated by puncturing the drop site with an injection needle.
  • the skin diagnostic tester 100 of the present invention is allergen and It is equipped with a needle for skin irritation so that the IgE antibody to the allergen can be identified by simply attaching it to the forearm of the back or arm.
  • Figure 2 is a perspective view of a needle-type skin diagnostic tester for diagnosing allergens according to an embodiment of the present invention.
  • the needle-type skin diagnostic tester for diagnosing allergens according to an embodiment of the present invention the diagnostic sheet 200 for receiving the diagnostic aid 220 and wound generation causing the skin irritation It may be composed of a sheet (300).
  • the diagnostic sheet 200 is provided with a compartment 210 to receive the diagnostic aid 220 inside the compartment 210 and to be attached to the skin to deliver the diagnostic aid 220 to the skin, and to generate a wound sheet 300.
  • the needle-type skin diagnostic tester for diagnosing allergens includes a diagnosis sheet 200 and a wound creation sheet 300.
  • the needle 310 is diagnosed.
  • the needle 310 may injure the skin and cause skin irritation.
  • the correct amount of the diagnostic aid 220 is embedded in the diagnostic sheet 200, when the diagnostic aid 220 is dropped onto the skin with the dropper, the expensive diagnostic aid 220 may not be dipped in an amount more than necessary. It is not wasted and can save cost.
  • FIG 3 is a perspective view of a needle-type skin diagnostic tester for diagnosing allergens according to another embodiment of the present invention
  • Figure 4 is a diagnostic sheet of the needle-type skin diagnostic tester for diagnosing allergens according to another embodiment of the present invention
  • the wound sheet 300 is folded to the diagnostic sheet 200 so that the needle 310 bursts the compartment 210 of the diagnostic sheet 200 and wounds the skin. It may be rotatably coupled to the diagnostic sheet (200). In this case, when the wound generating sheet 300 is rotated and folded to the diagnostic sheet 200, the needle 310 drops the diagnostic aid 220, and then causes a skin irritation by injuring the skin. In addition, the drip site of the diagnosis aid 220 and the stimulation site of the needle 310 may be exactly matched to increase the accuracy of the diagnosis.
  • a plurality of compartments 210 may be provided to accommodate different diagnostic aids 220, respectively. Since a plurality of compartments 210 of the diagnostic sheet 200 may be provided to accommodate various types of diagnostic aids 220, various types of allergens may be easily tested at one time.
  • a plurality of needles 310 may be provided so as to burst each of the plurality of compartments 210 and cause skin irritation.
  • the needle 310 of the wound-causing sheet 300 bursts each of the plurality of compartments 210 and stimulates skin irritated by the compartments 210. Should be induced. Therefore, a plurality of needles 310 of the wound-causing sheet 300 should be disposed in abutting position when folded with the compartment 210 of the diagnostic sheet 200.
  • the test can be started multiple times at the same time to confirm the time You can do exactly that. As such, when the time check is accurate and the time error is reduced, the result of the skin test can be read more accurately.
  • the dropper for dropping and the syringe needle for skin irritation should be prepared for each type of diagnostic aid 220 to prevent cross reaction.
  • the skin diagnostic tester of the present invention may include various types of diagnostic aids 220 and needles 310 for skin stimulation, thereby preventing waste of instruments such as dropper and syringe needles, thereby reducing costs.
  • the diagnostic sheet 200 is attached to the skin and serves to deliver the diagnostic aid 220 provided in the compartment 210 to the skin.
  • 5 is an enlarged cross-sectional view of a portion A of FIG. 3.
  • Diagnosis sheet 200 as shown in Figure 5, is disposed on the upper portion of the compartment 210 and the adhesive layer 230 coated with an adhesive on the edge of the compartment 210; And a cover layer 240 detachably attached to the adhesive layer 230 to protect the adhesive layer 230.
  • the adhesive layer 230 coated with the adhesive on the edge of the compartment 210 serves to fix the diagnostic sheet 200 to the skin, and the compartment 210 of the diagnostic sheet 200 is a wound creation sheet 300.
  • the cover layer 240 detachably attached on the adhesive layer 230, the adhesive layer 230 to protect the adhesive layer 230 until the use of the needle-type skin diagnostic tester for diagnosing allergens, and when removed, to improve skin adhesion It plays a role.
  • the diagnostic sheet 200 may further include at least one circular grid line around the needle 310 to check the degree to which the needle 310 causes skin irritation.
  • the skin test result is skin stimulation and after 15-20 minutes, the swelling and redness reaction site is measured with a ruler to determine the sensitized condition in the case of 3 mm or more.
  • a circular grid line around the needle 310 is provided separately. It is convenient because there is no need to prepare a ruler, and the grid lines are separated from the magnetic pole position at regular intervals so that accurate results can be confirmed when measuring.
  • the diagnostic sheet 200 and the wound sheet 300 is preferably a transparent material, the grid line is any of the diagnostic sheet 200 and the wound sheet 300 One or both of the diagnostic sheet 200 and the wound sheet 300 may be provided.
  • FIG. 6 is an enlarged cross-sectional view of part B of FIG. 3.
  • the wound sheet 300 may further include a cover member 320 detachably attached to the upper portion of the wound sheet 300 to protect the needle 310.
  • the wound sheet 300 is provided with a needle 310, the cover member 320 that can protect the needle 310 before the test is required.
  • the cover member 320 should be detachably provided so as to be removable when the skin diagnostic tester is used, and can be combined by various means such as adhesives, protrusions, and locking grooves.
  • the wound sheet 300 may be made of a transparent material so that the skin is visible when the wound sheet 300 is folded to the diagnostic sheet (200).
  • the test procedure such as the combination of the wound sheet 300 and the diagnostic sheet 200, the bursting of the compartment 210 and the skin irritation of the needle 310 can be visually confirmed, thereby improving accuracy in reading the test results. have.
  • the needle 310 serves to induce skin irritation by breaking the skin 210 by popping the compartment 210 of the diagnostic sheet 200 onto the skin, and then injuring the skin.
  • 7 is a cross-sectional view of a folded state of the diagnostic sheet 200 and the wound sheet 300 of the needle-type skin diagnostic tester for diagnosing allergens according to another embodiment of the present invention.
  • the needle 310 is attached to one surface of the wound-generating sheet 300 to rupture the compartment 210 and cause skin irritation, so that the depth of the needle 310 is 0.05 to 1.5 mm. Sieve.
  • Needle 310 of the wound sheet 300 is wound when the wound sheet 300 is folded on the diagnostic sheet 200, the needle (since the opening of the compartment 210 of the diagnostic sheet 200, and then wound the skin)
  • the length of 310 should be longer than the thickness of the diagnostic sheet (200).
  • the depth penetrated through the diagnostic sheet 200 and invaded by the skin becomes 0.05 to 1.5 mm, it can pass through the stratum corneum and give effective stimulation to the test. .
  • the needle is stimulated with a skin stimulation needle, the deviation occurs every time the test can give pain to the skin feeling unpleasant, but the needle 310 of the skin diagnostic tester of the present invention has a certain length, so the test is performed without deviation of pain can do.
  • the needle 310 may be composed of microneedles.
  • the needle 310 is a microneedle having an outer diameter, an inner diameter, and a length of several hundred micro-size needles, the needle 310 can injure the skin without pain when the needle 310 causes skin irritation, and thus the needle-equipped type for allergen diagnosis.
  • the use of a skin diagnostic tester becomes more convenient.
  • Diagnostic aid 220 serves to search for the causative antigen through the skin reaction test.
  • the diagnostic aid 220 may include any one of house dust mites, pollen, animal hair, food, mold, insects, allergens of drugs and metals, positive control histamine solution, negative control diluent. Almost all allergens consist of proteins, so any protein can be an allergen. In addition, substances other than proteins are combined with incomplete antigens (hapten) of small protein structure in the body to become allergens.
  • the test should be performed with a negative control, which should not respond to anyone, and a histamine solution, a positive control that causes swelling and redness in all, and the swelling produced by the histamine solution has a diameter of 3 mm or less or no redness. In case there is no reproducibility of the test.
  • the skin diagnosis tester 100 may be composed of a diagnostic sheet 200 and a wound sheet 300.
  • the diagnostic sheet 200 is provided with a compartment 210 for accommodating the diagnostic aid 220, and an adhesive layer 230 coated with an adhesive on an edge of the compartment 210 so as to be easily adhered to the skin at an upper portion of the compartment 210.
  • the wound sheet 300 is provided with a needle 310 that causes irritation to the skin, and a cover member 320 detachably attached to the upper portion of the wound sheet 300 to protect the needle 310 is further provided. Can be.
  • the wound sheet 300 may be rotatably coupled to the diagnostic sheet (200).
  • the cover layer 240 of the diagnostic sheet 200 is separated from the skin diagnostic tester 100, and then the adhesive layer 230 of the diagnostic sheet 200 is attached to the skin.
  • the cover member 320 of the wound sheet 300 is separated to expose the needle 310 of the wound sheet 300.
  • the needle 310 of the wound sheet 300 bursts the compartment 210 of the diagnostic sheet 200 to make the diagnosis aid 220 therein. ) Is applied to the skin, and then the needle 310 hurts the skin to cause skin irritation.
  • the needle 310 hurts the skin to cause skin irritation.

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Abstract

The present invention relates to a skin diagnosis tester having a needle for identifying an allergen. More specifically, the skin diagnosis tester comprises: a diagnosis sheet to be attached to the skin, the sheet having a compartment for storing a diagnosis aid; and a cut creating sheet having a needle to be used for poking the compartment when the diagnosis sheet is contacted, thereby drip-feeding the diagnosis aid into the skin and making a cut in the skin to induce skin stimulation. The skin diagnosis tester having a needle for identifying an allergen as proposed in the present invention uses needles for different types of diagnosis reagents that are used in a skin reaction test, and for stimulating the skin. As such, an accurate result can be read out by reducing a time error, and a wasteful use of instruments and reagents incorporated in the skin reaction test is reduced, thereby achieving a drop in expenditure.

Description

알레르겐 진단을 위한 바늘 구비형 피부 진단용 시험기Needle-type skin diagnostic tester for allergen diagnosis

본 발명은 알레르겐 진단을 위한 피부 진단용 시험기로서, 특히 정확한 결과 판독을 위한 알레르겐 진단을 위한 바늘 구비형 피부 진단용 시험기에 관한 것이다.The present invention relates to a skin diagnostic tester for diagnosing allergens, and more particularly to a needle-type skin diagnostic tester for diagnosing allergens for accurate reading of results.

피부반응시험은 알레르기 질환의 원인 항원을 검색하는데 가장 기본적인 진단 방법으로 사용되고 있으며, 짧은 시간 안에 환자에 비침습적 방법으로 원인 항원을 검색할 수 있어 널리 사용되고 있다.The skin test is used as the most basic diagnostic method to search for allergens of allergic diseases, and it is widely used to search for allergens in a non-invasive way.

알레르기는 면역학적 기전에 의해 야기되는 과민반응을 말하며, 항체 또는 세포에 의해서 매개된다. 알레르기 원인물질(알레르겐)에 감작된 사람은 알레르겐과 반응하는 특이 면역글로불린 E 항체(IgE)를 만든다. 이 특이 항체는 우리 몸 전체에 퍼져 있는 비만세포의 표면에 결합되어 있는데, 피부시험 시 피부를 통해서 알레르겐이 들어오면 이 알레르겐과 결합하여, 비만세포로부터 히스타민 등 여러 가지 화학매체들을 분비시킨다. 분비된 각종 화학매체는 혈관 확장 및 투과성 증가 등의 작용에 의해 즉각적인 팽진(wheal)과 발적(erythema) 반응을 일으킨다. 이러한 반응은 검사 시행 후 15∼20분경에 최고조에 달한다. 이때, 팽진과 발적의 크기를 자로 측정하여 팽진의 크기가 3㎜이상의 경우 감작 상태(sensitized state)로 간주한다.Allergy refers to hypersensitivity caused by immunological mechanisms and is mediated by antibodies or cells. A person sensitized to an allergen (allergen) produces a specific immunoglobulin E antibody (IgE) that reacts with the allergen. This specific antibody is bound to the surface of mast cells that spread throughout our body. When allergens enter through the skin during skin tests, they bind to the allergens and release various chemical media such as histamine from mast cells. Various secreted chemical media cause immediate swelling and erythema reactions by actions such as vasodilation and increased permeability. This response peaks 15 to 20 minutes after the test. At this time, the size of the swelling and redness is measured with a ruler, and when the size of the swelling is 3 mm or more, it is regarded as a sensitized state.

이 경우, 결과 판독 시점의 시간 오차가 작을수록 시험 결과의 재현성이 좋아지므로, 시간은 시험 결과에 작용하는 중요한 인자이다. 특히, 한 번에 여러 알레르겐 진단을 할 경우, 처음 시약 점적 시점과 마지막 시약 점적 시점의 시간 간격이 길어지면 결과 판독 시에 시간의 오차가 커지는 문제점이 발생할 수 있다. In this case, the smaller the time error at the time of reading the result, the better the reproducibility of the test result, and therefore time is an important factor acting on the test result. In particular, when a plurality of allergens are diagnosed at once, a long time interval between the first reagent drop time and the last reagent drop time may cause a problem in that the time error is increased when reading the result.

또한, 한 번에 여러 알레르겐을 진단할 때 교차 반응을 막기 위하여, 시약 종류마다 시약 점적을 위한 스포이트 및 피부 자극을 위한 주사기 바늘은 각각 준비되어야 하는데, 스포이트로 피부에 시약을 점적할 때 시약이 필요 이상의 양으로 점적되는 경우가 많아 고가의 시약이 낭비되는 문제점이 있다.In addition, to prevent cross reactions when diagnosing multiple allergens at once, a dropper for reagent dropping and a syringe needle for skin irritation should be prepared for each reagent type, and reagents are required when dropping reagents on the skin with a dropper. In many cases, the above-mentioned amount is dipped, and there is a problem that an expensive reagent is wasted.

본 발명은 기존에 제안된 방법들의 상기와 같은 문제점들을 해결하기 위해 제안된 것으로서, 피부반응시험에 사용되는 여러 종류의 진단 시약 및 피부 자극을 위한 바늘을 구비하여, 시간 오차를 줄임으로써 정확한 결과를 판독할 수 있고, 피부반응시험에 사용되는 기구 및 시약의 낭비를 줄여 비용을 절감할 수 있는, 알레르겐 진단을 위한 바늘 구비형 피부 진단용 시험기를 제공하는 것을 그 목적으로 한다.The present invention has been proposed to solve the above problems of the conventionally proposed methods, and includes various types of diagnostic reagents used in skin reaction tests and needles for skin irritation, thereby reducing the time error to obtain accurate results. It is an object of the present invention to provide a needle-type skin diagnostic tester for diagnosing allergens that can be read and can reduce costs by reducing waste of instruments and reagents used in skin reaction tests.

상기한 목적을 달성하기 위한 본 발명의 특징에 따른, 알레르겐 진단을 위한 바늘 구비형 피부 진단용 시험기는,In accordance with a feature of the present invention for achieving the above object, a needle-type skin diagnostic tester for allergen diagnosis,

진단용 보조물을 수용하는 격실이 구비되어 피부에 부착되는 진단시트; 및A diagnostic sheet attached to the skin having a compartment accommodating the diagnostic aid; And

상기 진단시트에 접촉되어 상기 격실을 터뜨려 내부의 진단용 보조물이 피부에 점적되고 피부에 상처를 내어 피부자극을 유발하도록, 바늘이 구비되는 상처생성시트를 포함하는 것을 그 구성상의 특징으로 한다.It is characterized in that it comprises a wound-forming sheet is provided with a needle to contact the diagnostic sheet to burst the compartment, the diagnostic aid therein is deposited on the skin and wound on the skin to cause skin irritation.

바람직하게는, 상기 상처생성시트는.Preferably, the wound sheet is.

상기 진단시트에 접철되어 상기 바늘이 상기 격실을 터뜨리고 피부에 상처를 내도록 상기 진단시트에 회전가능하게 결합될 수 있다.The needle may be rotatably coupled to the diagnostic sheet such that the needle ruptures the compartment and damages the skin.

바람직하게는, 상기 진단시트는,Preferably, the diagnostic sheet,

상기 격실의 상부에 배치되고 상기 격실의 테두리에 점착제가 코팅된 점착층; 및An adhesive layer disposed on an upper portion of the compartment and coated with an adhesive on an edge of the compartment; And

상기 점착층을 보호하도록 상기 점착층 상부에 분리가능하게 부착된 커버층을 더 구비할 수 있다.A cover layer detachably attached to an upper portion of the adhesive layer may be further provided to protect the adhesive layer.

바람직하게는, 상기 상처생성시트는,Preferably, the wound sheet is,

상기 바늘을 보호하도록 상기 상처생성시트 상부에 분리가능하게 부착된 커버 부재를 더 구비할 수 있다.A cover member detachably attached to an upper portion of the wound sheet may be further provided to protect the needle.

바람직하게는, 상기 바늘은,Preferably, the needle,

상기 격실을 터뜨리고 피부자극을 유발하도록 상기 상처생성시트의 일면에 부착되어 피부에 침습되는 깊이가 0.05 내지 1.5㎜가 되는 침상체로 구성될 수 있다.It may be composed of a needle body that is attached to one surface of the wound sheet to invade the skin to burst the compartment and cause skin irritation is 0.05 to 1.5mm.

바람직하게는, 상기 바늘은,Preferably, the needle,

마이크로 니들로 구성될 수 있다.It may consist of microneedles.

더욱 바람직하게는, 상기 격실은, 각각 다른 진단용 보조물을 수용할 수 있도록 복수 개가 구비되며,More preferably, the compartment is provided with a plurality, so that each can accommodate different diagnostic aids,

상기 바늘은, 상기 복수 개의 격실을 각각 터뜨리고 피부자극을 유발할 수 있도록 상기 복수 개의 격실에 각각 대응하여 복수 개가 구비될 수 있다.The needle may be provided in plural numbers corresponding to the plurality of compartments, respectively, so as to burst the plurality of compartments and cause skin irritation.

더욱 바람직하게는, 상기 진단용 보조물은,More preferably, the diagnostic aid,

집 먼지 진드기, 꽃가루, 동물의 털, 음식물, 곰팡이, 곤충, 약물 및 금속의 알레르기 항원 용액, 히스타민액인 양성대조액, 항원희석액인 음성대조액 중 어느 하나를 포함할 수 있다.House dust mites, pollen, animal hair, food, fungi, insects, allergens solutions of drugs and metals, a positive control of the histamine solution, a negative control of the antigen diluent may be included.

본 발명에서 제안하고 있는, 알레르겐 진단을 위한 바늘 구비형 피부 진단용 시험기에 따르면, 피부반응시험에 사용되는 여러 종류의 진단 시약 및 피부 자극을 위한 바늘을 구비하여, 시간 오차를 줄임으로써 정확한 결과를 판독할 수 있고, 피부반응시험에 사용되는 기구 및 시약의 낭비를 줄여 비용을 절감할 수 있다.According to the present invention, a needle-type skin diagnostic tester for diagnosing allergens is provided with various types of diagnostic reagents used for skin reaction tests and needles for skin stimulation, thereby reducing accurate time readings. The cost can be reduced by reducing the waste of instruments and reagents used in skin reaction tests.

도 1은 본 발명의 일 실시예에 따른 알레르겐 진단을 위한 바늘 구비형 피부 진단용 시험기의 사용 상태를 나타내는 도면.1 is a view showing a state of use of the needle-type skin diagnostic tester for diagnosing allergens according to an embodiment of the present invention.

도 2는 본 발명의 일 실시예에 따른 알레르겐 진단을 위한 바늘 구비형 피부 진단용 시험기의 사시도.Figure 2 is a perspective view of a needle-type skin diagnostic tester for allergen diagnosis according to an embodiment of the present invention.

도 3은 본 발명의 다른 실시예에 따른 알레르겐 진단을 위한 바늘 구비형 피부 진단용 시험기의 사시도.Figure 3 is a perspective view of a needle-type skin diagnostic tester for diagnosing allergens according to another embodiment of the present invention.

도 4는 본 발명의 다른 실시예에 따른 알레르겐 진단을 위한 바늘 구비형 피부 진단용 시험기의 진단시트와 상처생성시트의 접철상태의 사시도.Figure 4 is a perspective view of the folded state of the diagnostic sheet and the wound sheet of the needle-type skin diagnostic tester for diagnosing allergens according to another embodiment of the present invention.

도 5는 도 2의 A 부분의 확대 단면도.5 is an enlarged cross-sectional view of a portion A of FIG. 2.

도 6은 도 2의 B 부분의 확대 단면도.6 is an enlarged cross-sectional view of a portion B of FIG. 2.

도 7은 본 발명의 다른 실시예에 따른 알레르겐 진단을 위한 바늘 구비형 피부 진단용 시험기의 진단시트와 상처생성시트의 접철상태의 단면도.Figure 7 is a cross-sectional view of the folded state of the diagnostic sheet and the wound sheet of the needle-type skin diagnostic tester for diagnosing allergens according to another embodiment of the present invention.

<도면 중 주요 부분에 대한 부호의 설명><Explanation of symbols for main parts of the drawings>

100: 피부 진단용 시험기 200: 진단시트100: skin diagnostic tester 200: diagnostic sheet

210: 격실 220: 진단용 보조물210: compartment 220: diagnostic aid

230: 점착층 240: 커버층230: adhesion layer 240: cover layer

300: 상처생성시트 310: 바늘300: wound making sheet 310: needle

320: 커버 부재320: cover member

이하에서는 첨부된 도면들을 참조하여, 본 발명에 따른 실시예에 대하여 상세하게 설명하기로 한다.Hereinafter, exemplary embodiments of the present invention will be described in detail with reference to the accompanying drawings.

도 1은 본 발명의 일 실시예에 따른 알레르겐 진단을 위한 바늘 구비형 피부 진단용 시험기의 사용 상태를 나타내는 도면이다. 도 1에 도시된 바와 같이, 본 발명의 일 실시예에 따른 알레르겐 진단을 위한 바늘 구비형 피부 진단용 시험기(100)는, 특이 알레르겐에 대한 IgE 항체를 확인하는 시험인 피부반응시험에 사용될 수 있다. 피부반응시험은 등 또는 팔의 전박부에 검사항원용액과 양성대조액 및 음성대조액을 점적한 후 주사바늘로 점적 부위를 찔러 자극하게 되는데, 본 발명의 피부 진단용 시험기(100)는 패치 형태로 알레르겐 및 피부 자극을 위한 바늘이 구비되어 있어 등 또는 팔의 전박부에 간단하게 붙이는 과정을 통해 알레르겐에 대한 IgE 항체를 확인할 수 있다.1 is a view showing the state of use of the needle-type skin diagnostic tester for diagnosing allergens according to an embodiment of the present invention. As shown in FIG. 1, the needle-type skin diagnostic tester 100 for diagnosing allergens according to an embodiment of the present invention may be used for a skin reaction test, which is a test for identifying IgE antibodies against specific allergens. In the skin reaction test, the test antigen solution, the positive control solution and the negative control solution are instilled into the forearm or the forearm of the arm, and then the needle is irritated by puncturing the drop site with an injection needle. The skin diagnostic tester 100 of the present invention is allergen and It is equipped with a needle for skin irritation so that the IgE antibody to the allergen can be identified by simply attaching it to the forearm of the back or arm.

도 2는 본 발명의 일 실시예에 따른 알레르겐 진단을 위한 바늘 구비형 피부 진단용 시험기의 사시도이다. 도 2에 도시된 바와 같이, 본 발명의 일 실시예에 따른 알레르겐 진단을 위한 바늘 구비형 피부 진단용 시험기는, 진단용 보조물(220)을 수용하는 진단시트(200)와 피부에 자극을 유발하는 상처생성시트(300)로 구성될 수 있다. 진단시트(200)는 격실(210)이 구비되어 격실(210)의 내부에 진단용 보조물(220)을 수용하고 피부에 부착되어 진단용 보조물(220)을 피부에 전달하는 역할을 하고 상처생성시트(300)는 상처생성시트(300)의 바늘(310)로 진단용 보조물(220)을 피부에 점적하고 피부자극을 유발하는 역할을 한다. 알레르겐 진단을 위한 바늘 구비형 피부 진단용 시험기는 진단시트(200) 및 상처생성시트(300)를 포함하여, 상처생성시트(300)가 진단시트(200)에 접촉되는 경우, 바늘(310)이 진단시트(200)의 격실(210)을 터뜨려 내부의 진단용 보조물(220)이 피부에 점적된 후에, 바늘(310)이 피부에 상처를 내어 피부자극을 유발할 수 있다. 이처럼, 진단 보조물(220)을 스포이트로 점적하고 피부자극용 바늘을 별도로 준비하는 과정이 없으며 피부 표면에 상처를 일으키게 하기 위한 처치를 별도로 실시할 필요가 없어지므로, 시험에 필요한 시간을 단축할 수 있다. 또한, 진단시트(200)에 정확한 양의 진단 보조물(220)이 내재되어 있어 스포이트로 피부에 진단 보조물(220)을 점적할 때 필요 이상의 양으로 점적되는 경우가 없어 고가의 진단 보조물(220)이 낭비되지 않아 비용을 절감시킬 수 있다.Figure 2 is a perspective view of a needle-type skin diagnostic tester for diagnosing allergens according to an embodiment of the present invention. As shown in Figure 2, the needle-type skin diagnostic tester for diagnosing allergens according to an embodiment of the present invention, the diagnostic sheet 200 for receiving the diagnostic aid 220 and wound generation causing the skin irritation It may be composed of a sheet (300). The diagnostic sheet 200 is provided with a compartment 210 to receive the diagnostic aid 220 inside the compartment 210 and to be attached to the skin to deliver the diagnostic aid 220 to the skin, and to generate a wound sheet 300. ) Serves as a needle 310 of the wound sheet 300 to drip the diagnostic aid 220 on the skin and cause skin irritation. The needle-type skin diagnostic tester for diagnosing allergens includes a diagnosis sheet 200 and a wound creation sheet 300. When the wound creation sheet 300 is in contact with the diagnosis sheet 200, the needle 310 is diagnosed. After the compartment 210 of the sheet 200 is opened and the diagnostic aid 220 therein is deposited on the skin, the needle 310 may injure the skin and cause skin irritation. As such, there is no process of dropping the diagnostic aid 220 with the dropper and separately preparing a needle for stimulation of the skin, and eliminating the need for a separate treatment for causing a wound on the skin surface, thereby reducing the time required for the test. . In addition, since the correct amount of the diagnostic aid 220 is embedded in the diagnostic sheet 200, when the diagnostic aid 220 is dropped onto the skin with the dropper, the expensive diagnostic aid 220 may not be dipped in an amount more than necessary. It is not wasted and can save cost.

도 3은 본 발명의 다른 실시예에 따른 알레르겐 진단을 위한 바늘 구비형 피부 진단용 시험기의 사시도이고, 도 4는 본 발명의 다른 실시예에 따른 알레르겐 진단을 위한 바늘 구비형 피부 진단용 시험기의 진단시트와 상처생성시트의 접철 상태의 사시도이다.3 is a perspective view of a needle-type skin diagnostic tester for diagnosing allergens according to another embodiment of the present invention, Figure 4 is a diagnostic sheet of the needle-type skin diagnostic tester for diagnosing allergens according to another embodiment of the present invention; A perspective view of the folded state of a wound sheet.

상처생성시트(300)는, 도 3 및 도 4에 도시된 바와 같이, 진단시트(200)에 접철되어 바늘(310)이 진단시트(200)의 격실(210)을 터뜨리고 피부에 상처를 내도록 진단시트(200)에 회전가능하게 결합될 수 있다. 이 경우, 상처생성시트(300)가 회전하여 진단시트(200)에 접철되면 바늘(310)이 진단 보조물(220)을 점적한 다음 피부에 상처를 내어 피부자극을 유발하게 한다. 그리고 진단 보조물(220)의 점적 부위와 바늘(310)의 자극 부위가 정확히 일치하여 진단의 정확도를 높일 수 있다.3 and 4, the wound sheet 300 is folded to the diagnostic sheet 200 so that the needle 310 bursts the compartment 210 of the diagnostic sheet 200 and wounds the skin. It may be rotatably coupled to the diagnostic sheet (200). In this case, when the wound generating sheet 300 is rotated and folded to the diagnostic sheet 200, the needle 310 drops the diagnostic aid 220, and then causes a skin irritation by injuring the skin. In addition, the drip site of the diagnosis aid 220 and the stimulation site of the needle 310 may be exactly matched to increase the accuracy of the diagnosis.

또한, 격실(210)은 각각 다른 진단용 보조물(220)을 수용할 수 있도록 복수 개가 구비될 수 있다. 진단시트(200)의 격실(210)이 복수 개가 구비되어 있어 여러 종류의 진단 보조물(220)을 수용할 수 있어 여러 종류의 알레르겐을 한 번에 간편하게 시험할 수 있다.In addition, a plurality of compartments 210 may be provided to accommodate different diagnostic aids 220, respectively. Since a plurality of compartments 210 of the diagnostic sheet 200 may be provided to accommodate various types of diagnostic aids 220, various types of allergens may be easily tested at one time.

또한, 바늘(310)은 복수 개의 격실(210)을 각각 터뜨리고 피부자극을 유발할 수 있도록 복수 개가 구비될 수 있다. 진단시트(200)의 격실(210)이 복수 개가 구비될 경우, 상처유발시트(300)의 바늘(310)은 복수 개의 격실(210)을 각각 터뜨리고 격실(210)이 닿아있는 피부의 자극을 유발하여야 한다. 그러므로 상처유발시트(300)의 바늘(310)은 진단시트(200)의 격실(210)과 접철될 때 맞닿는 위치에 복수 개가 배치되어야 한다. 이 경우, 여러 종류의 진단 보조물(220) 및 피부 자극을 위한 바늘(310)을 구비하여, 다양한 종류의 진단 보조물(220)이 피부반응시험에 사용되더라도 동시 다발적으로 테스트를 시작할 수 있어 시간 확인을 정확하게 할 수 있다. 이처럼, 시간 확인이 정확해져 시간 오차가 줄어들면 피부반응시험의 결과를 좀 더 정확하게 판독할 수 있다.In addition, a plurality of needles 310 may be provided so as to burst each of the plurality of compartments 210 and cause skin irritation. When a plurality of compartments 210 of the diagnostic sheet 200 are provided, the needle 310 of the wound-causing sheet 300 bursts each of the plurality of compartments 210 and stimulates skin irritated by the compartments 210. Should be induced. Therefore, a plurality of needles 310 of the wound-causing sheet 300 should be disposed in abutting position when folded with the compartment 210 of the diagnostic sheet 200. In this case, with various types of diagnostic aid 220 and needle 310 for skin irritation, even if various types of diagnostic aid 220 is used in the skin reaction test, the test can be started multiple times at the same time to confirm the time You can do exactly that. As such, when the time check is accurate and the time error is reduced, the result of the skin test can be read more accurately.

또한, 한 번에 여러 종류의 진단 보조물(220)을 사용하여 피부반응시험을 할 경우, 교차 반응을 막기 위하여 진단 보조물(220) 종류마다 점적을 위한 스포이트 및 피부 자극을 위한 주사기 바늘은 각각 준비되어야 하는데, 본 발명의 피부 진단용 시험기는 여러 종류의 진단 보조물(220) 및 피부 자극을 위한 바늘(310)을 구비하여 스포이트 및 주사기 바늘 등의 기구 낭비를 막아 비용을 절감할 수 있다.In addition, when a skin reaction test is performed using several types of diagnostic aids 220 at a time, the dropper for dropping and the syringe needle for skin irritation should be prepared for each type of diagnostic aid 220 to prevent cross reaction. However, the skin diagnostic tester of the present invention may include various types of diagnostic aids 220 and needles 310 for skin stimulation, thereby preventing waste of instruments such as dropper and syringe needles, thereby reducing costs.

진단시트(200)는, 피부에 부착되어 격실(210)에 구비되어있는 진단용 보조물(220)을 피부에 전달하는 역할을 한다. 도 5는 도 3의 A 부분의 확대 단면도이다. 진단시트(200)는, 도 5에 도시된 바와 같이, 격실(210)의 상부에 배치되고 격실(210)의 테두리에 점착제가 코팅된 점착층(230); 및 점착층(230)을 보호하도록 점착층(230) 상부에 분리가능하게 부착된 커버층(240)을 더 구비할 수 있다. 격실(210)의 테두리에 점착제가 코팅된 점착층(230)은, 진단시트(200)를 피부에 고정시키는 역할을 하는 동시에, 진단시트(200)의 격실(210)이 상처생성시트(300)의 바늘(310)에 의해 터졌을 때, 종류가 각각 다른 진단 보조물(220)이 피부에서 섞이지 않게 하여 테스트의 결과를 정확하게 한다. 또한, 점착층(230) 상부에 분리가능하게 부착된 커버층(240)은 알레르겐 진단을 위한 바늘 구비형 피부 진단용 시험기의 사용 전까지 점착층(230)을 보호하고, 사용 시 제거하여 피부 부착력을 좋게 하는 역할을 한다.The diagnostic sheet 200 is attached to the skin and serves to deliver the diagnostic aid 220 provided in the compartment 210 to the skin. 5 is an enlarged cross-sectional view of a portion A of FIG. 3. Diagnosis sheet 200, as shown in Figure 5, is disposed on the upper portion of the compartment 210 and the adhesive layer 230 coated with an adhesive on the edge of the compartment 210; And a cover layer 240 detachably attached to the adhesive layer 230 to protect the adhesive layer 230. The adhesive layer 230 coated with the adhesive on the edge of the compartment 210 serves to fix the diagnostic sheet 200 to the skin, and the compartment 210 of the diagnostic sheet 200 is a wound creation sheet 300. When burst by the needle 310, the different types of diagnostic aids 220 do not mix in the skin to ensure accurate test results. In addition, the cover layer 240 detachably attached on the adhesive layer 230, the adhesive layer 230 to protect the adhesive layer 230 until the use of the needle-type skin diagnostic tester for diagnosing allergens, and when removed, to improve skin adhesion It plays a role.

또한, 진단시트(200)는, 도면에 도시되지는 않았지만, 바늘(310)이 피부자극을 유발한 정도를 확인하도록 바늘(310)을 중심으로 적어도 하나 이상의 원형의 눈금선을 더 구비할 수 있다. 피부반응시험 결과는 피부 자극을 유발한 다음 15∼20분경 팽진과 발적 반응 부위를 자로 측정하여 3㎜이상의 경우 감작 상태로 판정하게 되는데, 바늘(310)을 중심으로 원형의 눈금선을 구비하여 따로 자를 준비할 필요가 없어 편리하며, 눈금선이 자극 위치에서부터 일정한 간격으로 떨어져 있어 측정할 때 정확한 결과를 확인할 수 있다. 이때, 감작 부위에 해당하는 정확한 눈금선을 읽기 위하여 진단시트(200) 및 상처생성시트(300)는 투명한 재질인 것이 바람직하며, 눈금선은 진단시트(200) 및 상처생성시트(300) 중 어느 하나, 혹은 진단시트(200) 및 상처생성시트(300) 모두에 구비될 수 있다.In addition, although not shown in the drawing, the diagnostic sheet 200 may further include at least one circular grid line around the needle 310 to check the degree to which the needle 310 causes skin irritation. . The skin test result is skin stimulation and after 15-20 minutes, the swelling and redness reaction site is measured with a ruler to determine the sensitized condition in the case of 3 mm or more. A circular grid line around the needle 310 is provided separately. It is convenient because there is no need to prepare a ruler, and the grid lines are separated from the magnetic pole position at regular intervals so that accurate results can be confirmed when measuring. At this time, in order to read the exact grid line corresponding to the sensitization site, the diagnostic sheet 200 and the wound sheet 300 is preferably a transparent material, the grid line is any of the diagnostic sheet 200 and the wound sheet 300 One or both of the diagnostic sheet 200 and the wound sheet 300 may be provided.

상처생성시트(300)는, 진단시트(200)에 접철되어 상처생성시트(300)의 바늘(310)로 진단용 보조물(220)을 피부에 점적하고 피부자극을 유발하는 역할을 한다. 도 6은 도 3의 B 부분의 확대 단면도이다. 상처생성시트(300)는, 도 6에 도시된 바와 같이, 바늘(310)을 보호하도록 상처생성시트(300) 상부에 분리가능하게 부착된 커버 부재(320)를 더 구비할 수 있다. 상처생성시트(300)는 바늘(310)을 구비하고 있어, 시험 실시 이전에 바늘(310)을 보호할 수 있는 커버 부재(320)가 필요하다. 커버 부재(320)는 피부 진단용 시험기의 사용 시에 제거 가능하도록 분리가능하게 구비되어야 하며, 접착제 및 돌기와 걸림 홈 등의 다양한 수단으로 결합될 수 있다. 또한, 상처생성시트(300)가 진단시트(200)에 접철되는 경우 피부가 보일 수 있도록, 투명한 재질로 구성될 수 있다. 이 경우, 상처생성시트(300)와 진단시트(200)의 결합, 격실(210)의 터짐 및 바늘(310)의 피부 자극 등의 시험 과정을 눈으로 확인할 수 있어 시험 결과 판독에 정확성을 높일 수 있다.The wound creation sheet 300 is folded to the diagnostic sheet 200 to serve as a needle 310 of the wound creation sheet 300 to drip the diagnostic aid 220 onto the skin and cause skin irritation. FIG. 6 is an enlarged cross-sectional view of part B of FIG. 3. As shown in FIG. 6, the wound sheet 300 may further include a cover member 320 detachably attached to the upper portion of the wound sheet 300 to protect the needle 310. The wound sheet 300 is provided with a needle 310, the cover member 320 that can protect the needle 310 before the test is required. The cover member 320 should be detachably provided so as to be removable when the skin diagnostic tester is used, and can be combined by various means such as adhesives, protrusions, and locking grooves. In addition, the wound sheet 300 may be made of a transparent material so that the skin is visible when the wound sheet 300 is folded to the diagnostic sheet (200). In this case, the test procedure, such as the combination of the wound sheet 300 and the diagnostic sheet 200, the bursting of the compartment 210 and the skin irritation of the needle 310 can be visually confirmed, thereby improving accuracy in reading the test results. have.

바늘(310)은, 진단시트(200)의 격실(210)을 터뜨려 내부의 진단용 보조물(220)을 피부에 점적한 후에, 피부에 상처를 내어 피부자극을 유발하는 역할을 한다. 도 7은 본 발명의 다른 실시예에 따른 알레르겐 진단을 위한 바늘 구비형 피부 진단용 시험기의 진단시트(200)와 상처생성시트(300)의 접철 상태의 단면도이다. 바늘(310)은, 도 6에 도시된 바와 같이, 격실(210)을 터뜨리고 피부자극을 유발하도록 상처생성시트(300)의 일면에 부착되어 피부에 침습되는 깊이가 0.05 내지 1.5㎜가 되는 침상체로 구성될 수 있다. 상처생성시트(300)의 바늘(310)은 상처생성시트(300)가 진단시트(200)에 접철되는 경우, 진단시트(200)의 격실(210)을 터뜨린 다음 피부에 상처를 내야하므로 바늘(310)의 길이는 진단시트(200)의 두께보다 길어야 한다. 특히, 진단시트(200)를 뚫고 나와 피부에 침습되는 깊이가 0.05 내지 1.5㎜가 되면 각질층을 통과하여 시험에 유효한 자극을 줄 수 있고, 피부를 자극하더라도 통증을 느끼는 정도가 미미하여 시험 적합성이 우수하다. 또한, 피부자극용 바늘로 찔러 자극할 때는 시험 시마다 편차가 생겨 피부에 통증을 느껴 불쾌감을 줄 수 있으나 본 발명의 피부 진단용 시험기의 바늘(310)은 일정한 길이를 가지므로 통증의 편차 없이 시험을 실시할 수 있다.The needle 310 serves to induce skin irritation by breaking the skin 210 by popping the compartment 210 of the diagnostic sheet 200 onto the skin, and then injuring the skin. 7 is a cross-sectional view of a folded state of the diagnostic sheet 200 and the wound sheet 300 of the needle-type skin diagnostic tester for diagnosing allergens according to another embodiment of the present invention. As shown in FIG. 6, the needle 310 is attached to one surface of the wound-generating sheet 300 to rupture the compartment 210 and cause skin irritation, so that the depth of the needle 310 is 0.05 to 1.5 mm. Sieve. Needle 310 of the wound sheet 300 is wound when the wound sheet 300 is folded on the diagnostic sheet 200, the needle (since the opening of the compartment 210 of the diagnostic sheet 200, and then wound the skin) The length of 310 should be longer than the thickness of the diagnostic sheet (200). In particular, when the depth penetrated through the diagnostic sheet 200 and invaded by the skin becomes 0.05 to 1.5 mm, it can pass through the stratum corneum and give effective stimulation to the test. . In addition, when the needle is stimulated with a skin stimulation needle, the deviation occurs every time the test can give pain to the skin feeling unpleasant, but the needle 310 of the skin diagnostic tester of the present invention has a certain length, so the test is performed without deviation of pain can do.

또한, 바늘(310)은, 마이크로 니들로 구성될 수 있다. 바늘(310)이 외경, 내경 및 길이가 수백 마이크로 사이즈의 바늘인 마이크로 니들인 경우, 바늘(310)이 피부자극을 유발할 때 통증이 없이 피부에 상처를 낼 수 있어, 알레르겐 진단을 위한 바늘 구비형 피부 진단용 시험기의 사용이 더욱 편리해진다.In addition, the needle 310 may be composed of microneedles. In the case where the needle 310 is a microneedle having an outer diameter, an inner diameter, and a length of several hundred micro-size needles, the needle 310 can injure the skin without pain when the needle 310 causes skin irritation, and thus the needle-equipped type for allergen diagnosis. The use of a skin diagnostic tester becomes more convenient.

진단용 보조물(220)은, 피부반응시험을 통하여 원인 항원을 검색하는 역할을 한다. 진단용 보조물(220)은 집 먼지 진드기, 꽃가루, 동물의 털, 음식물, 곰팡이, 곤충, 약물 및 금속의 알레르기 항원 용액, 히스타민액인 양성대조액, 항원희석액인 음성대조액 중 어느 하나를 포함할 수 있다. 거의 모든 알레르겐은 단백질로 구성되어 있어 어떤 단백질도 알레르겐이 될 수 있다. 또한, 단백질이 아닌 물질도 체내에서 작은 단백질 구조의 불완전항원(hapten)과 결합되어 알레르겐이 된다. 또한, 검사를 시행할 때는 누구에게도 반응이 없어야 하는 음성 대조액과 모두에게서 팽진과 발적을 일으키는 양성 대조액인 히스타민 용액을 동시에 사용해야 하며 히스타민 용액에 의해 생기는 팽진의 직경이 3㎜ 이하이거나 발적이 동반되지 않는 경우에는 시험의 재현성이 없다.Diagnostic aid 220 serves to search for the causative antigen through the skin reaction test. The diagnostic aid 220 may include any one of house dust mites, pollen, animal hair, food, mold, insects, allergens of drugs and metals, positive control histamine solution, negative control diluent. Almost all allergens consist of proteins, so any protein can be an allergen. In addition, substances other than proteins are combined with incomplete antigens (hapten) of small protein structure in the body to become allergens. In addition, the test should be performed with a negative control, which should not respond to anyone, and a histamine solution, a positive control that causes swelling and redness in all, and the swelling produced by the histamine solution has a diameter of 3 mm or less or no redness. In case there is no reproducibility of the test.

상기와 같이 구성되는 본 발명에 따른 알레르겐 진단을 위한 바늘 구비형 피부 진단용 시험기(100)의 동작을 설명하면 다음과 같다. 먼저, 피부 진단용 시험기(100)는 진단시트(200)와 상처생성시트(300)로 구성될 수 있다. 진단시트(200)는 진단용 보조물(220)을 수용하는 격실(210)이 구비되고, 격실(210)의 상부에는 피부에 점착이 용이하도록 격실(210)의 테두리에 점착제가 코팅된 점착층(230)이 배치되고, 점착층(230)의 상부에는 피부에 부착 전까지 점착층(230)을 보호하도록 분리가능하게 부착된 커버층(240)을 더 구비할 수 있다. 상처생성시트(300)는 피부에 자극을 유발하는 바늘(310)이 구비되고, 바늘(310)을 보호하도록 상처생성시트(300) 상부에 분리가능하게 부착된 커버 부재(320)가 더 구비될 수 있다. 또한 상처생성시트(300)는 진단시트(200)에 회전가능하게 결합될 수 있다. 피부 진단용 시험기(100)를 사용하는 경우, 진단시트(200)의 커버층(240)을 피부 진단용 시험기(100)로부터 분리하여 진단시트(200)의 점착층(230)을 피부에 부착한 다음, 상처생성시트(300)의 커버 부재(320)를 분리하여 상처생성시트(300)의 바늘(310)을 노출시킨다. 이후, 상처생성시트(300)를 회전하여 진단시트(200)에 접철시키면, 상처생성시트(300)의 바늘(310)이 진단시트(200)의 격실(210)을 터뜨려 내부의 진단용 보조물(220)이 피부에 점적된 다음, 바늘(310)이 피부에 상처를 내어 피부자극을 유발하게 된다. 이와 같이, 피부반응시험에 사용되는 여러 종류의 진단용 보조물(220) 및 피부 자극을 위한 바늘(310)을 구비하여, 한 번에 여러 종류의 진단용 보조물(220)을 테스트함으로써, 시간 오차를 줄여 정확한 결과를 판독할 수 있고 피부반응시험에 사용되는 기구 및 시약의 낭비를 현저히 줄여 비용을 절감할 수 있다.Referring to the operation of the needle-type skin diagnostic tester 100 for diagnosing allergen according to the present invention configured as described above are as follows. First, the skin diagnosis tester 100 may be composed of a diagnostic sheet 200 and a wound sheet 300. The diagnostic sheet 200 is provided with a compartment 210 for accommodating the diagnostic aid 220, and an adhesive layer 230 coated with an adhesive on an edge of the compartment 210 so as to be easily adhered to the skin at an upper portion of the compartment 210. ) Is disposed, and a cover layer 240 detachably attached to protect the adhesive layer 230 until the adhesive layer 230 is attached to the skin. The wound sheet 300 is provided with a needle 310 that causes irritation to the skin, and a cover member 320 detachably attached to the upper portion of the wound sheet 300 to protect the needle 310 is further provided. Can be. In addition, the wound sheet 300 may be rotatably coupled to the diagnostic sheet (200). When using the skin diagnostic tester 100, the cover layer 240 of the diagnostic sheet 200 is separated from the skin diagnostic tester 100, and then the adhesive layer 230 of the diagnostic sheet 200 is attached to the skin. The cover member 320 of the wound sheet 300 is separated to expose the needle 310 of the wound sheet 300. Thereafter, when the wound sheet 300 is rotated and folded to the diagnostic sheet 200, the needle 310 of the wound sheet 300 bursts the compartment 210 of the diagnostic sheet 200 to make the diagnosis aid 220 therein. ) Is applied to the skin, and then the needle 310 hurts the skin to cause skin irritation. In this way, by providing a variety of diagnostic aids 220 and needles 310 for skin irritation used in the skin reaction test, by testing several types of diagnostic aids 220 at a time, by reducing the time error accurate Results can be read and costs can be reduced by significantly reducing the waste of instruments and reagents used in skin reaction testing.

이상 설명한 본 발명은 본 발명이 속한 기술분야에서 통상의 지식을 가진 자에 의하여 다양한 변형이나 응용이 가능하며, 본 발명에 따른 기술적 사상의 범위는 아래의 특허청구범위에 의하여 정해져야 할 것이다.The present invention described above may be variously modified or applied by those skilled in the art, and the scope of the technical idea according to the present invention should be defined by the following claims.

Claims (8)

알레르겐 진단을 위한 바늘 구비형 피부 진단용 시험기로서,A needle-type skin diagnostic tester for allergen diagnosis, 진단용 보조물을 수용하는 격실이 구비되어 피부에 부착되는 진단시트; 및A diagnostic sheet attached to the skin having a compartment accommodating the diagnostic aid; And 상기 진단시트에 접촉되어 상기 격실을 터뜨려 내부의 진단용 보조물이 피부에 점적되고 피부에 상처를 내어 피부자극을 유발하도록, 바늘이 구비되는 상처생성시트를 포함하는 것을 특징으로 하는, 알레르겐 진단을 위한 바늘 구비형 피부 진단용 시험기.A needle for diagnosing allergens, comprising: a wound generation sheet provided with a needle to contact the diagnosis sheet to burst the compartment, thereby causing an internal diagnosis aid to be deposited on the skin and to injure the skin to cause skin irritation. Embedded skin diagnostic tester. 제1항에 있어서, 상기 상처생성시트는,The method of claim 1, wherein the wound sheet, 상기 진단시트에 접철되어 상기 바늘이 상기 격실을 터뜨리고 피부에 상처를 내도록 상기 진단시트에 회전가능하게 결합되는 것을 특징으로 하는, 알레르겐 진단을 위한 바늘 구비형 피부 진단용 시험기.A needle-type skin diagnostic tester for diagnosing allergens, wherein the needle is rotatably coupled to the diagnostic sheet so that the needle bursts the compartment and damages the skin. 제1항에 있어서, 상기 진단시트는,The method of claim 1, wherein the diagnostic sheet, 상기 격실의 상부에 배치되고 상기 격실의 테두리에 점착제가 코팅된 점착층; 및An adhesive layer disposed on an upper portion of the compartment and coated with an adhesive on an edge of the compartment; And 상기 점착층을 보호하도록 상기 점착층 상부에 분리가능하게 부착된 커버층을 더 구비하는 것을 특징으로 하는, 알레르겐 진단을 위한 바늘 구비형 피부 진단용 시험기.And a cover layer detachably attached on the adhesive layer to protect the adhesive layer, wherein the needle-type skin diagnostic tester for allergen diagnosis. 제1항에 있어서, 상기 상처생성시트는,The method of claim 1, wherein the wound sheet, 상기 바늘을 보호하도록 상기 상처생성시트 상부에 분리가능하게 부착된 커버 부재를 더 구비하는 것을 특징으로 하는, 알레르겐 진단을 위한 바늘 구비형 피부 진단용 시험기.And a cover member detachably attached to the wound generating sheet to protect the needle. The needle-type skin diagnostic tester for diagnosing allergens. 제1항에 있어서, 상기 바늘은,The method of claim 1, wherein the needle, 상기 격실을 터뜨리고 피부자극을 유발하도록 상기 상처생성시트의 일면에 부착되어 피부에 침습되는 깊이가 0.05 내지 1.5㎜가 되는 침상체인 것을 특징으로 하는, 알레르겐 진단을 위한 바늘 구비형 피부 진단용 시험기.A needle-type skin diagnostic tester for diagnosing allergens, characterized in that the needle is attached to one surface of the wound generating sheet to invade the skin to burst the compartment and cause skin irritation. 제1항에 있어서, 상기 바늘은,The method of claim 1, wherein the needle, 마이크로 니들인 것을 특징으로 하는, 알레르겐 진단을 위한 바늘 구비형 피부 진단용 시험기.A needle-type skin diagnostic tester for allergen diagnosis, characterized in that it is a microneedle. 제1항 내지 제6항 중 어느 한 항에 있어서,The method according to any one of claims 1 to 6, 상기 격실은, 각각 다른 진단용 보조물을 수용할 수 있도록 복수 개가 구비되며,The compartment is provided with a plurality, so that each can accommodate different diagnostic aids, 상기 바늘은, 상기 복수 개의 격실을 각각 터뜨리고 피부자극을 유발할 수 있도록 상기 복수 개의 격실에 각각 대응하여 복수 개가 구비되는 것을 특징으로 하는, 알레르겐 진단을 위한 바늘 구비형 피부 진단용 시험기.The needle, the needle-type skin diagnostic tester for diagnosing allergens, characterized in that a plurality is provided corresponding to each of the plurality of compartments to burst the plurality of compartments and cause skin irritation, respectively. 제1항 내지 제6항 중 어느 한 항에 있어서, 상기 진단용 보조물은,The method according to any one of claims 1 to 6, wherein the diagnostic aid, 집 먼지 진드기, 꽃가루, 동물의 털, 음식물, 곰팡이, 곤충, 약물 및 금속의 알레르기 항원 용액, 히스타민액인 양성대조액, 항원희석액인 음성대조액 중 어느 하나를 포함하는 것을 특징으로 하는, 알레르겐 진단을 위한 바늘 구비형 피부 진단용 시험기.House dust mite, pollen, animal hair, food, fungus, insects, allergens of the drug and metal allergen solution, histamine solution positive control, antigen dilution negative control, characterized in that any one of the diagnostic allergens for Needle-type skin diagnostic tester.
PCT/KR2010/007481 2009-10-28 2010-10-28 Skin diagnosis tester having a needle for allergen identification WO2011053018A2 (en)

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