KR20090032409A - Blood analyzing device equipped with blood suction collection device and blood pretreatment device - Google Patents

Blood analyzing device equipped with blood suction collection device and blood pretreatment device Download PDF

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KR20090032409A
KR20090032409A KR1020070097628A KR20070097628A KR20090032409A KR 20090032409 A KR20090032409 A KR 20090032409A KR 1020070097628 A KR1020070097628 A KR 1020070097628A KR 20070097628 A KR20070097628 A KR 20070097628A KR 20090032409 A KR20090032409 A KR 20090032409A
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KR100900655B1 (en
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신은정
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신은정
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    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/483—Physical analysis of biological material
    • G01N33/487—Physical analysis of biological material of liquid biological material
    • G01N33/49—Blood
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    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/150007—Details
    • A61B5/150755—Blood sample preparation for further analysis, e.g. by separating blood components or by mixing
    • 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
    • Y10S435/00—Chemistry: molecular biology and microbiology
    • Y10S435/97—Test strip or test slide

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Abstract

A blood analyzing device equipped with blood suction collection unit and blood pretreatment unit is provided to enable an operator to examine various blood tests at a time within a short time. A blood analyzing device comprises the following units. A blood chamber stores gathered blood. A blood delivering structure delivers the gathered blood to a blood examination unit. A plurality of structures for blood examination are included. The blood analyzing device is equipped with a blood inflow unit placed in an airtight vessel, the blood chamber connected to the blood inflow unit and a blood pretreatment unit including a blood serum chamber which is divided into a blood corpuscle separator and a blood serum blocker to collect filtered blood.

Description

흡입채혈장치와 혈액 전처리장치가 내장된 혈액검사기구{blood analyzing device equipped with blood suction collection device and blood pretreatment device}Blood analyzing device equipped with blood suction collection device and blood pretreatment device

혈액검사Blood test

기존 혈액검사기관의 혈액검사에서는, 주사기나 진공채혈관을 이용하여 채혈을 한 후에 이 혈액을 검사실로 보낸 후 혈구제거 등의 전처리과정을 거쳐 이를 래피드진단시약을 포함한 여러 가지 혈액검사장치에 일일이 조심스럽게 손으로 옮겨주어야만 검사가 가능한 어려움과 불편함이 있다.In the blood test of the existing blood test institute, blood is collected by using a syringe or a vacuum collection tube, and then the blood is sent to a laboratory, followed by pretreatment such as blood cell removal, and carefully treated with various blood test devices including a rapid diagnostic reagent. It is difficult and uncomfortable to be tested only by hand.

이 과정에서 다수의 검사용 일회용품들의 사용과 인력낭비로 검사비용이 늘어나는 문제가 있을 뿐 아니라 각 단계의 혈액취급과정에서 검체의 뒤바뀜으로 인한 의료사고와 함께 질병감염 혈액과의 접촉으로 인한 의료인의 이차감염도 우려되며, 또한 응급상황에 있어서는 검사결과가 나올 때까지 적절한 응급조치를 취할 수 없는 어려움이 있다.In this process, there is a problem that the test cost is increased due to the use of a large number of disposable disposable products and manpower wasted, and also the secondary medical personnel due to contact with the infected blood along with medical accidents due to the inversion of the sample in the blood handling process at each stage. Infection is also a concern, and in emergencies, it is difficult to take appropriate first aid measures until the test results are available.

한편, 기존의 혈액검사장치 제조업체에서는 각각의 혈액검사장치를 별도로 제조 및 방습제포장을 하여 제조원가가 늘어나는 문제점이 있으며 방습제포장 불량으로 인한 제품불량발생의 우려도 있다.On the other hand, the existing blood test device manufacturers have a separate manufacturing and packaging of each desiccant and the desiccant has a problem that the manufacturing cost increases, there is a fear of product defects due to poor desiccant packaging.

더욱이 정상적으로 포장을 하더라도 포장재 안의 잔여공기와 잔여수분이 혈액검사장치에 코팅되어 있는 활성단백질 혹은 활성화학물질의 안정성에 악영향을 주어 결과적으로 제품의 성능을 악화시킬 우려도 있으며, 래피드진단시약과 같은 혈액검사장치의 경우는 습도변화와 같은 외부환경에 의해 검사결과가 영향받는 문제점도 있다.Moreover, even if the product is properly packaged, residual air and residual moisture in the packaging may adversely affect the stability of the active protein or activator coated on the blood test apparatus, resulting in deterioration of product performance and blood tests such as rapid diagnostic reagents. In the case of the device, there is a problem that the test results are affected by the external environment such as humidity change.

본 발명에서는 채혈장치와 혈액처리장치와 여러 혈액검사장치를 통합하여 밀폐된 공간 안에 모두 모아 넣는 방식으로 상기의 기존 문제점들을 해결하고자 하였다.In the present invention, the above problems are solved by integrating a blood collection device, a blood processing device, and several blood test apparatuses and collecting them in a closed space.

본 발명의 기구를 사용할 경우 채혈과정 이후부터 검사완료까지 아무런 조작이 필요치 않아 래피드진단카드와 같은 기존의 검사장치에 비해서 더 빠르고 간편하며, 여러 혈액검사를 단일기구 내에서 동시에 실시할 수 있어 저렴하고 효과적으로 혈액검사를 실시할 수 있다. 특히 응급상황에 있어서 각종 사전 혈액검사들을 검사실에 검체를 보내어 실시하는 대신 채혈 직후에 신속하게 동시에 실시할 수 있으므로 적절한 응급조치를 신속히 취하는데 큰 도움이 된다.In the case of using the apparatus of the present invention, since no manipulation is required from the blood collection process to the completion of the test, it is faster and simpler than the conventional test apparatus such as a rapid diagnosis card, and it is inexpensive because several blood tests can be performed simultaneously in a single apparatus. Blood tests can be done effectively. In particular, in an emergency, various pre-blood tests can be performed at the same time immediately after blood collection instead of sending a sample to a laboratory, which is a great help in promptly taking appropriate first aid measures.

채혈된 혈액이 기구 밖으로 전혀 노출되지 않으므로 질병의 이차감염이 방지됨과 동시에 채혈된 혈액의 공기접촉에서 오는 분석물질의 변형이나 습도변화로 인 한 검사결과 오류도 방지할 수 있다.Since the collected blood is never exposed outside the instrument, secondary infection of the disease can be prevented and test results can be prevented due to changes in the analyte or changes in humidity caused by air contact of the collected blood.

본 발명의 기구를 사용하여 채혈 및 혈액검사를 시작한 직후에 다른 검사를 위하여 추가로 채혈이 필요한 경우는 이미 혈관에 꽂혀 있는 채혈침을 그대로 이용하여 추가로 진공채혈관을 연결하여 필요한 만큼 채혈할 수 있으므로 채혈대상체에 주는 통증을 최소화 할 수 있다.If additional blood collection is required for another test immediately after starting blood collection and blood test using the apparatus of the present invention, it is possible to draw additional blood as needed by connecting additional vacuum blood vessels as they are already plugged into blood vessels. The pain in the blood collection subject can be minimized.

여러 혈액검사장치가 단일기구 내에 통합되어 있어 제조시 원가가 낮다.Several blood test devices are integrated into a single device, resulting in low manufacturing costs.

종래 혈액검사장치는 포장파손으로 습기가 유입되어 제품성능이 저하되어도 인지가 불가능 하나 본 발명의 기구는 파손으로 인해 습기가 유입되어 성능이 저하될 경우 채혈 자체가 불가능하게 되어 쉽게 인지할 수 있으므로 검사기구의 성능을 항상 보장할 수 있다.Conventional blood test apparatus can not be recognized even if the product performance is degraded due to moisture inflow due to packaging damage, but the instrument of the present invention can be easily recognized because it is impossible to collect blood when the moisture is degraded due to breakage and performance is reduced. The performance of the instrument can always be guaranteed.

본 발명의 기구에서는, 진공시험관과 같이 채혈을 위해 진공이 유지되는 밀폐용기 내부에 '도 1' 과 같이, 혈액유입관에 연결된 혈액실, 혈구분리체와 혈청차단체로 구획되어 여과된 혈액을 수집하는 혈청실을 순차적으로 설치하고, 이 혈청실에 단일 혹은 다중의 스트립 혹은 카드형 혈액검사장치들의 검체공급부위를 연결함으로써, 채혈장치, 검체 전처리장치, 검사장치를 함께 하나의 밀폐공간에 밀집시킨다.In the apparatus of the present invention, as shown in Figure 1 inside the sealed container to maintain the vacuum for blood collection, such as a vacuum test tube, blood is divided into blood chambers, blood cell separators and serum difference groups connected to the blood inlet tube and filtered Collect blood serum, sample pretreatment and test equipment together in one confined space by installing the serum chamber to collect sequentially and connecting the sample supply part of single or multiple strip or card type blood test apparatus to this serum chamber. Let's do it.

본 발명의 기구의 구조를 자세히 살펴보면, 채혈침이 결합되는 고무마개가 최상단부를 구성하고, 혈액유입관의 하부에 연결되어 있는 혈액실이 본 검사기구의 최하단부를 구성하며, 이 혈액실 바로 위쪽에 혈액유입관을 둘러싸는 고리형태로 혈청실이 배치된다.Looking at the structure of the device of the present invention in detail, the rubber stopper is coupled to the blood collection needle constitutes the top end, the blood chamber connected to the lower portion of the blood inlet pipe constitutes the bottom end of the test mechanism, the blood inflow just above the blood chamber The serum chamber is placed in the form of a ring surrounding the tube.

혈청실과 혈액실의 경계에는 혈구를 분리할 수 있는 여과체 형태의 혈구분리체가 부착되고, 혈청실의 상부에는 혈액흡입에 방해가 되지 않게 공기가 유통되면서도 분리된 혈청은 내보내지 않도록 소수성다공막 혹은 작은 기공이 있는 격막형태의 혈청차단체가 부착된다.At the boundary between the serum chamber and the blood chamber, a hemocytometer in the form of a filter body capable of separating blood cells is attached, and a hydrophobic porous membrane or Diaphragm-like groups with small pores are attached.

검사에 사용되는 스트립 혹은 카드형 혈액검사장치는 혈액유입관의 외벽에 부착되며, 부착된 혈액검사장치들의 말단에 위치한 검체공급부위를 혈청차단체를 관통하여 혈청실로 직접 연결시키는 방식으로 채혈된 혈액을 검체공급부위로 전달하는 혈액전달구조물을 형성한다.The strip or card-type blood test apparatus used for the test is attached to the outer wall of the blood inlet tube, and the blood collected by directly connecting the sample supply site located at the end of the attached blood test apparatus to the serum chamber through the serum difference group. Form a blood delivery structure that delivers to the sample supply site.

본 발명의 기구의 변형으로써 "도 2" 와 같이 별도의 혈청실과 혈구분리체를 설치하지 않고 직접 검체공급부위가 혈청차단체를 관통하여 혈액실로 연결되는 형태의 혈액전달구조 또한 가능하다.As a modification of the apparatus of the present invention, as shown in FIG. 2, a blood delivery structure in which a sample supply site is directly connected to a blood chamber through a serum difference unit without installing a separate serum chamber and blood cell separator is also possible.

또한, 본 발명의 기구의 변형으로써 "도 3" 과 같이 별도의 혈청실과 혈구분리체와 혈청차단체를 설치하지 않고 직접 검체공급부위가 혈액실로 연결되는 형태의 혈액전달구조 또한 가능하다.In addition, as a modification of the apparatus of the present invention, as shown in FIG. 3, a blood delivery structure in which a sample supply site is directly connected to a blood chamber without installing a separate serum chamber, blood cell separator, and serum difference group is also possible.

본 발명의 기구는 감마선 등의 멸균과정을 거쳐 무균상태를 유지한다.The apparatus of the present invention maintains a sterile state through a sterilization process such as gamma rays.

본 발명의 기구의 작동원리를 살펴보면 아래와 같다.Looking at the operation principle of the apparatus of the present invention.

먼저 검체 채취를 위하여 채혈침을 혈관에 삽입한 후 본 발명의 기구를 채혈침의 반대쪽에 연결하게 되면 채혈침 반대쪽의 침이 본 기구의 최상단에 위치한 고 무마개를 관통하게 되는데, 이때 시험관 내의 진공으로 인하여 혈액이 혈액유입관을 통하여 혈액실로 흡입되게 된다. 혈액실로의 혈액유입이 지속되면 혈구분리체를 통하여 혈구가 제거된 혈청이 혈청실로 밀려 올라가서 혈청실을 채우게 된다.First, when the needle is inserted into a blood vessel for sampling, and the instrument of the present invention is connected to the other side of the needle, the needle on the opposite side of the needle penetrates the rubber stopper located at the top of the instrument. The blood inlet is sucked into the blood chamber. If blood flow continues into the blood chamber, the blood cells are removed from the blood cell through the hemocytometer is pushed to the serum chamber to fill the serum chamber.

혈청실이 절반 이상 차오르게 되면 본 발명의 기구를 채혈침에서 분리하여 채혈을 멈추고 시험관 랙(Rack)에 끼워 수직으로 세워놓는다. 혈청실에 수집된 혈청은 혈청실로 돌출되어 나온 혈액검사장치들의 검체공급부위를 통하여 각 혈액검사장치로 공급되게 되며, 이때부터 각 혈액검사장치들에 의한 실제 혈액검사반응들이 시작되게 된다. 검사반응이 종료되면 본 발명의 기구의 투명한 외벽을 통하여 기구내에 보이는 혈액검사결과를 판독하게 된다.When the serum chamber is more than half full, the apparatus of the present invention is removed from the blood collection needle, the blood collection is stopped, and the vertically inserted into the test tube rack. Serum collected in the serum chamber is supplied to each blood test apparatus through the sample supply site of blood test apparatuses protruding into the serum chamber, from which the actual blood test reactions by the blood test apparatuses are started. Upon completion of the test reaction, the blood test results shown in the device are read through the transparent outer wall of the device of the present invention.

결론적으로, 본 발명의 기구는 외부환경과 완전히 격리된 작은 공간 내에서 채혈과 동시에 여러 가지 혈액검사들을 즉석에서 실시할 수 있는 특징이 있으므로 각종 혈액검사시에 대단히 유용하게 쓰일 것으로 예상된다.In conclusion, the apparatus of the present invention is expected to be very useful in various blood tests because it has the characteristic of performing various blood tests on the fly at the same time as the blood collection in a small space completely isolated from the external environment.

또한 본 발명의 기구는 스트립 혹은 카드형태의 어떠한 소형 검사장치에도 검체를 자동으로 공급할 수 있기 때문에, 본 발명에 장착할 수 있는 혈액검사장치는 임신자가진단기와 같은 래피드진단카드 외에도 랩온어칩(Lab-on-a-chip) 등과 같은 여러 형태의 소형 혈액검사장치들이 될 수 있으므로 적용범위 또한 폭 넓다.In addition, since the apparatus of the present invention can automatically supply a sample to any small test device in the form of a strip or card, the blood test device that can be mounted in the present invention is a lab-on-a-chip in addition to a rapid diagnostic card such as a pregnant self-diagnosis machine. The range of applications is also wide, as there are several types of small blood test devices such as on-a-chip.

본 발명의 기구의 대표적 적용사례로써, HBV,anti-HBV,HCV,HIV 의 4개의 래피드 진단스트립이 동시에 장착된 혈액검사기구를 들 수 있으며, 소변검사스트립과 유사한 형태로 건강검진시에 즉석혈액검사를 위해 사용될 것으로 예상된다. 이때 채혈침을 혈관에 삽입한 후 각종 검사를 위한 채혈관을 결합하여 필요한 혈액을 채 취한 후 마지막에 본 발명의 기구를 채혈침에 다시 결합하여 위의 4종의 혈액검사를 동시에 실시간으로 실시하고 소변검사결과 판독과 유사하게 혈액검사결과를 즉석에서 판독하여 건강검진자에게 알려줄 수 있을 것으로 예상된다.Representative application examples of the apparatus of the present invention include a blood test apparatus equipped with four rapid diagnostic strips of HBV, anti-HBV, HCV, and HIV. It is expected to be used for inspection. At this time, after inserting the blood needle into the blood vessels, the blood vessels for various tests were combined to collect the necessary blood, and finally, the apparatus of the present invention was combined again with the blood needles to simultaneously perform the above four blood tests in real time and urine test. Similar to reading results, it is expected that blood test results can be read on the fly and informed to the health examiner.

개별의 카세트에 포장되어 공급되는 기존의 래피드진단카드 제품들을 대체할 새로운 통합 피오씨티(Point of Care Test) 진단키트 출시를 가능케 하는 새로운 개념의 발명이므로 그 상업성은 크다고 하겠음.The commercialization of the new concept enables the launch of a new integrated point of care test diagnostic kit that replaces existing rapid diagnostic card products packaged in individual cassettes.

본 발명은 건강검진, 병원내원 혈액검사, 응급실, 구급차 등에서 생화학검사, 이화학검사, 카디악(Cardiac), 암 등에 대한 표지자검사 등 각종 혈액검사에 사용될 것으로 예상되며 향후 대부분의 기존 래피드진단카드를 대체할 수 있음.The present invention is expected to be used in various blood tests, such as biochemical tests, physicochemical tests, cardiac (Cardiac), cancer, etc. in the medical examination, hospital hospital blood test, emergency room, ambulance, etc. and replace most existing rapid diagnostic cards in the future. You can.

도 1 은 발명된 기구의 측면도이며 기구의 주요구조부분인 혈액유입관이 혈청차단체 및 혈구분리체와 각각 연결되는 부분의 단면도를 도면 왼쪽에 각각 표시하였음.Figure 1 is a side view of the device invented and a cross-sectional view of a portion of the blood inlet pipe, which is a major structural part of the device, respectively connected to the serum difference groups and hemocytometers, respectively, on the left side of the drawing.

도 2 는 발명된 기구의 변형구조에 대한 측면도이며 기구의 주요구조부분인 혈액유입관이 혈청차단체와 연결되는 부분의 단면도를 도면 왼쪽에 표시하였음.Figure 2 is a side view of a modified structure of the invention invented and a cross-sectional view of the portion of the blood inlet pipe, which is the main structural part of the device and connected to the serum difference groups on the left side of the figure.

도 3 은 발명된 기구의 변형구조에 대한 측면도이며 기구의 주요구조부분인 혈액유입관의 단면도를 도면 왼쪽에 표시하였음.Figure 3 is a side view of the modified structure of the device invented and a cross-sectional view of the blood inlet pipe, which is a major structural part of the device, is shown on the left side of the figure.

Claims (3)

음압을 이용한 흡입채혈을 하고 동시에 채혈된 혈액을 저장하는 혈액실과; 혈액을 한 개 이상의 혈액검사장치 검체공급부위에 전달하기 위한 혈액전달구조물; 한 개 이상의 혈액검사장치; 를 포함하는 혈액검사용 구조물들이 하나의 혈액검사기구 내에 연이어 설치되어 있으며, 이 기구 내에서 채혈과 검사용 검체공급을 일괄적으로 처리하는 것을 특징으로 하는 혈액검사기구.A blood chamber that stores suctioned blood using negative pressure and simultaneously stores blood collected; A blood delivery structure for delivering blood to at least one blood test sample supply site; One or more blood test apparatus; Blood test structures comprising a successive is installed in one blood test apparatus, the blood test apparatus, characterized in that the processing of the blood collection and the supply of the test sample in this apparatus collectively. 채혈을 위해 진공이 유지되는 밀폐용기 내에, 혈액유입관과; 이에 연결된 혈액실; 혈구분리체와 혈청차단체로 구획되어 여과된 혈액을 수집하는 혈청실; 을 포함하는 일련의 혈액 전처리장치들이 설치되어 있고, 이 혈액 전처리장치들의 말단에 한개 이상의 피오씨티(Point of Care Test)용 혈액검사장치들의 검체공급부위가 연결되어 있으며, 이 기구 내에서 채혈과 검사용 검체공급을 일괄적으로 처리하는 것을 특징으로 하는 혈액검사기구.A blood inlet pipe in a sealed container in which a vacuum is maintained for blood collection; Blood chambers connected thereto; A serum chamber for collecting filtered blood divided into hemocytometers and serum difference groups; A series of blood pretreatment devices are installed, and a sample supply portion of one or more points of care test blood test devices is connected to the ends of the blood pretreatment devices. A blood test apparatus, characterized in that for processing the supply of a sample for the batch. 제1항에 있어서, 래피드진단스트립 혹은 랩온어칩과 같은 피오씨티(Point of Care Test)장치를 혈액검사장치로 설치하는 것을 특징으로 하는 혈액검사기구.The blood test apparatus according to claim 1, wherein a point of care test device such as a rapid diagnostic strip or a lab-on-a-chip is provided as a blood test device.
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