WO2010114183A1 - Blood testing kit having suction type sampling equipment which collects a predetermined volume of blood - Google Patents

Blood testing kit having suction type sampling equipment which collects a predetermined volume of blood Download PDF

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Publication number
WO2010114183A1
WO2010114183A1 PCT/KR2009/001588 KR2009001588W WO2010114183A1 WO 2010114183 A1 WO2010114183 A1 WO 2010114183A1 KR 2009001588 W KR2009001588 W KR 2009001588W WO 2010114183 A1 WO2010114183 A1 WO 2010114183A1
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Prior art keywords
blood
test apparatus
plasma
chamber
test
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PCT/KR2009/001588
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French (fr)
Korean (ko)
Inventor
신은정
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Shin Eunjung
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Priority to PCT/KR2009/001588 priority Critical patent/WO2010114183A1/en
Publication of WO2010114183A1 publication Critical patent/WO2010114183A1/en

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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
    • A61B5/15—Devices for taking samples of blood
    • A61B5/150007—Details
    • A61B5/150358—Strips for collecting blood, e.g. absorbent
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/150007—Details
    • A61B5/150015—Source of blood
    • A61B5/15003—Source of blood for venous or arterial blood
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/153—Devices specially adapted for taking samples of venous or arterial blood, e.g. with syringes
    • A61B5/154—Devices using pre-evacuated means
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/150007—Details
    • A61B5/150374—Details of piercing elements or protective means for preventing accidental injuries by such piercing elements
    • A61B5/150381—Design of piercing elements
    • A61B5/150389—Hollow piercing elements, e.g. canulas, needles, for piercing the skin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/150007—Details
    • A61B5/150374—Details of piercing elements or protective means for preventing accidental injuries by such piercing elements
    • A61B5/150381—Design of piercing elements
    • A61B5/150473—Double-ended needles, e.g. used with pre-evacuated sampling tubes

Definitions

  • quoting invention a blood test apparatus which enables a quick and simultaneous operation from the collection of blood to the completion of a blood test.
  • the blood collected by the needle in the container holding the decompression inside is collected in the first space part, separated into serum and plasma through a filter, and connected to the blood test strip for blood test through the serum lower part.
  • the configuration is shown so that blood collection and testing can be performed collectively.
  • the invention of the present invention coincides with the appearance that a blood test is carried out at the same time as a blood sample by putting a strip test reagent in an airtight container
  • the cited invention is an unstable method of simply dropping the blood being collected by a filter onto a single test strip.
  • the present invention has a fundamental difference in that the blood is accurately and effectively delivered to multiple test strips through a sophisticated blood flow control structure in which the unique serum difference group of the present invention is installed.
  • the blood is collected by using a syringe or vacuum tube, and then the blood is sent to the laboratory, and the blood can be carefully and manually transferred to various blood test apparatuses including rapid diagnostic reagents. There is difficulty and discomfort.
  • 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.
  • a blood test apparatus (hereinafter referred to as "quoting invention") that enables to perform at the same time quickly from the collection of blood of the Japanese Patent Publication No. 17-009888 (2005.01.13) to the completion of the blood test
  • the invention of the present invention has a technical problem of supplying plasma in an unspecified volume to the blood test strip in a dynamic state through the lower part, there is a technical problem that causes a considerable deviation in the test results. There is also a problem that can not be supplied exactly to the supply unit to the blood test strips to the main body to cause incorrect test results.
  • the structure of the cited invention is a state in which the blood needle is connected, that is, the test container is laid horizontally. Only the plasma can be supplied to the test strip.
  • the structure of dropping the filtered plasma to the test strip through the lower part of the cited invention it is almost impossible to accurately supply the sample to the test strip in a horizontal state, so the invention has a fatal technical defect that cannot be put to practical use.
  • the blood collection apparatus is integrated with several blood test apparatuses, and together with the method of collecting all of them in a confined space, only a certain volume of blood is stably filled in a limited space, and the filled blood is supplied to a sample of multiple blood test apparatuses.
  • the device 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 existing test apparatus such as a rapid diagnostic card, and it is inexpensive because several blood tests can be performed simultaneously in a single device. 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.
  • the collected blood is never exposed outside the device, the secondary infection of the disease is prevented and the test result error due to the deformation or humidity change of the analyte from the air contact of the collected blood can be prevented.
  • the test strip has no adverse effect on the operation of the test strip due to the characteristic of the blood chamber structure without the unique flow of the present invention. There is no possibility of failure and it is easy to use.
  • Figure 1 is a side view of the device invented and a cross-sectional view of a portion of the blood inlet pipe that is the main structural part of the device connected to the blood tea group is shown on the left side of the figure.
  • Figure 2 is a side view of the expanded structure of the device of the present invention, the cross-sectional view of the portion of the blood inlet pipe, which is the main structural part of the device is connected to the blood tea group and blood cell separators, respectively, on the left side of the figure.
  • Figure 3 is a side view of a modified structure of the device of the invention 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.
  • a blood chamber connected to a blood inlet tube, a blood car group, and a negative pressure chamber are sequentially installed in a sealed container in which a vacuum is maintained for blood collection, such as a vacuum test tube.
  • the rubber stopper is coupled to the blood collection needle constitutes the top end, the blood chamber is connected to the lower portion of the blood inlet tube constitutes the lower end of the test device, the blood inlet tube just above the blood chamber
  • the sound pressure chamber is arranged in the form of a surrounding ring.
  • a diaphragm or float valve with a hydrophobic porous membrane or pores or a diaphragm with pores is installed so that air and blood or plasma or serum are not distributed while preventing blood intake.
  • a blood tea group in the form of pore diaphragms is installed.
  • the strip or card-type blood test apparatus used for the test is installed on the outer wall of the blood inlet tube, and the blood collected by directly connecting the sample supply site located at the distal end of the attached blood test apparatus to the blood chamber through the blood car group Form a blood delivery structure that delivers to the sample supply site.
  • a blood cell separator in the form of a filter which can separate blood cells in the middle of the blood chamber may be installed to supply only plasma instead of whole blood to the test strip. In this case, of course, there is no need to attach the blood cell removal sheet on the test strip.
  • FIG. 3 there is also a structure in which blood collected without a separate negative pressure chamber and blood difference unit is directly connected to the sample supply site.
  • the device of the present invention can maintain a sterile state through a sterilization process such as gamma rays.
  • the needle when the needle is inserted into a blood vessel for sampling, and the device of the present invention is connected to the opposite side of the needle, the needle on the opposite side of the needle penetrates the rubber stopper located at the top of the device.
  • the blood flows to the bottom of the blood chamber through the blood inlet tube and fills the blood chamber.
  • the device of the present invention When the blood chamber fills up, the device of the present invention is removed from the lancet and inserted into a test tube rack and placed vertically. Blood collected in the blood chamber is supplied to each blood test apparatus through sample supply sites of blood test apparatuses protruding into the blood chamber, from which the actual blood test reactions by the blood test apparatuses are started.
  • the needle is inserted into the human blood vessel horizontally close to the ground, so the device of the present invention is also almost horizontal to the ground when connected to the blood collection needle, and the collected blood is blocked by the blood group and flows into the test strip body. It can't be safely locked inside the blood chamber, and even when the test device is rotated to stand in a rack, blood fluctuations inside the blood chamber are completely prevented to perform accurate blood tests.
  • the blood test results displayed on the blood test apparatus are read through the transparent outer wall of the apparatus of the present invention.
  • the device 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 and at the same time stably in a small space completely isolated from the external environment.
  • the device 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 on 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 can be many types of small blood test instruments such as on-a-chip.
  • Representative applications of the device of the present invention include a blood test device equipped with four rapid diagnostic strips of HBV, anti-HBV, HCV, and HIV at the same time. It is expected to be used for inspection. At this time, after inserting the blood collection needle into the blood vessels, the blood vessels for various tests are combined to collect the necessary blood, and finally, the device of the present invention is combined with the blood collection needles at the same time to perform the above four blood tests simultaneously 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.
  • 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.
  • 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.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Medical Informatics (AREA)
  • Biophysics (AREA)
  • Pathology (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Hematology (AREA)
  • Physics & Mathematics (AREA)
  • Molecular Biology (AREA)
  • Surgery (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Investigating Or Analysing Biological Materials (AREA)
  • Sampling And Sample Adjustment (AREA)

Abstract

The present invention relates to a blood test apparatus in which a negative pressure chamber along with a blood sample chamber is installed within a vacuum container, to take a blood sample in a predetermined amount and maintains the blood sample stably in the blood sample chamber, which is limited by a blood barrier installed in the lower end of the blood sample chamber to block the inflow of blood, and to a blood test kit having at least one blood test strip or card connected to the blood sample chamber, so that the blood can be accurately and simultaneously transferred to the blood test kit thereby performing multiple blood tests in an simple and quick manner.

Description

채혈량이 일정하게 유지되는 흡입채혈기구를 가지는 혈액검사장치Blood test apparatus having inhalation blood collection device to keep blood collection constant
혈액검사Blood test
일본공개특허공보 평17-009888호(2005.01.13.)에는 혈액의 채취로부터 혈액 검사의 완료까지 동시에 신속히 행하는 것을 가능하게 하는 혈액 검사용 장치(이하 "인용발명"이라 함)에 대하여 기재되어 있는데, 여기에는 내부에 감압을 유지하고 있는 용기 내에 채혈침에 의해 채혈된 혈액이 제1공간부에 모이고, 필터를 통하여 혈청과 혈장으로 분리되고, 혈청 유하부를 통하여 혈액 검사를 위해 혈액 검사 스트립으로 연결되도록 하여 채혈과 검사를 일괄적으로 실시할 수 있도록 하는 구성이 나타나 있다.Japanese Patent Application Laid-open No. Hei 17-009888 (2005.01.13.) Describes a blood test apparatus (hereinafter referred to as "quoting invention") which enables a quick and simultaneous operation from the collection of blood to the completion of a blood test. Here, the blood collected by the needle in the container holding the decompression inside is collected in the first space part, separated into serum and plasma through a filter, and connected to the blood test strip for blood test through the serum lower part. The configuration is shown so that blood collection and testing can be performed collectively.
인용발명과 본 발명은 스트립검사시약을 밀폐용기 안에 집어넣어 채혈과 동시에 혈액검사를 한다는 외형에서는 일치하지만, 인용발명이 채혈되고 있는 혈액을 필터로 걸러 단일 검사스트립 위에 단순히 떨어뜨리는 불안정한 방식인데 반하여, 본 발명은 채혈된 혈액을 본 발명 고유의 혈청차단체가 설치된 정교한 혈액실 흐름조절 구조를 통하여 정확하고 효과적으로 다중의 검사스트립에 전달하는 방식이라는 점에서 근본적인 차이가 있다.While the invention of the present invention coincides with the appearance that a blood test is carried out at the same time as a blood sample by putting a strip test reagent in an airtight container, the cited invention is an unstable method of simply dropping the blood being collected by a filter onto a single test strip. The present invention has a fundamental difference in that the blood is accurately and effectively delivered to multiple test strips through a sophisticated blood flow control structure in which the unique serum difference group of the present invention is installed.
기존 혈액검사기관의 혈액검사에서는, 주사기나 진공채혈관을 이용하여 채혈을 한 후에 이 혈액을 검사실로 보낸 후 이를 래피드진단시약을 포함한 여러 가지 혈액검사기구에 일일이 조심스럽게 손으로 옮겨주어야만 검사가 가능한 어려움과 불편함이 있다.In the blood test of the existing blood test institute, the blood is collected by using a syringe or vacuum tube, and then the blood is sent to the laboratory, and the blood can be carefully and manually transferred to various blood test apparatuses including rapid diagnostic reagents. There is difficulty and discomfort.
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 혈액검사기구 제조업체에서는 각각의 혈액검사기구를 별도로 제조 및 방습제포장을 하여 제조원가가 늘어나는 문제점이 있으며 방습제포장 불량으로 인한 제품불량발생의 우려도 있다.On the other hand, conventional blood test apparatus manufacturers have a problem in that the manufacturing cost is increased by manufacturing and packaging each blood test apparatus separately, and there is a fear of product defects due to poor packaging of the desiccant.
더욱이 정상적으로 포장을 하더라도 포장재 안의 잔여공기와 잔여수분이 혈액검사기구에 코팅되어 있는 활성단백질 혹은 활성화학물질의 안정성에 악영향을 주어 결과적으로 제품의 성능을 악화시킬 우려도 있으며, 래피드진단시약과 같은 혈액검사기구의 경우는 습도변화와 같은 외부환경에 의해 검사결과가 영향받는 문제점도 있다.Moreover, even if the product is properly packaged, residual air and residual moisture in the package 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 instruments, the test results are also affected by external conditions such as humidity changes.
한편, 상기 문제점들을 해결하기 위하여 일본공개특허공보 평17-009888호(2005.01.13)의 혈액의 채취에서부터 혈액검사의 완료까지 동시에 신속히 행하는 것을 가능하게 하는 혈액검사용장치(이하 "인용발명"이라 함)가 발명되었으나, 인용발명은 유하부를 통하여 혈액검사스트립에 불특정한 부피의 혈장을 동적인 상태에서 공급할 수 밖에 없어서 검사결과에 상당한 편차를 가져오는 기술적 문제점이 있으며, 혈장을 혈액검사스트립의 검체공급부에만 정확히 공급하지 못하고 혈액검사스트립 본체에까지 튀어 들어가게 하여 부정확한 검사결과를 유발할 수 있는 문제점도 있다.On the other hand, in order to solve the above problems, a blood test apparatus (hereinafter referred to as "quoting invention") that enables to perform at the same time quickly from the collection of blood of the Japanese Patent Publication No. 17-009888 (2005.01.13) to the completion of the blood test Although the invention of the present invention has a technical problem of supplying plasma in an unspecified volume to the blood test strip in a dynamic state through the lower part, there is a technical problem that causes a considerable deviation in the test results. There is also a problem that can not be supplied exactly to the supply unit to the blood test strips to the main body to cause incorrect test results.
또한 인용발명에서는 혈장이 필터 하부의 유하부를 통한 중력에 의한 낙하에 의해 검사스트립에 공급되기 때문에 혈장흐름을 다중의 스트립으로 적절히 분기시킬 수가 없으므로 다중의 혈액검사스트립을 설치하는 것이 용이하지 않으므로, 여러검사를 동시에 신속하게 수행해야 하는 응급실과 같은 상황에서는 사용하기 어려운 문제점이 있다.In addition, in the cited invention, since plasma is supplied to the test strip by dropping by gravity through the lower part of the lower part of the filter, plasma flow cannot be properly branched into multiple strips, so it is not easy to install multiple blood test strips. This is difficult to use in situations such as an emergency room where the tests must be performed quickly at the same time.
더 나아가 인용발명에서는 진공채혈 후 진공용기에서 채혈침이 분리되어 혈액공급이 중단되면 동시에 혈액여과가 중단되므로, 인용발명의 구조는 결국 채혈침이 연결된 채혈 중 상태, 즉 검사용기가 수평으로 누워져 있는 상태에서만 혈장이 검사스트립으로 공급될 수 있는 구조이다. 그러나 인용발명의 유하부를 통해 검사스트립에 여과된 혈장을 떨어뜨리는 구조에서는 수평상태에서 검사스트립에 검체를 정확히 공급하는 것이 거의 불가능하므로, 인용발명은 실용화가 불가능한 치명적인 기술적 결함이 있다.Furthermore, in the cited invention, since the blood needle is separated from the vacuum vessel after the blood collection and the blood supply is stopped, the blood filtration is stopped at the same time. Therefore, the structure of the cited invention is a state in which the blood needle is connected, that is, the test container is laid horizontally. Only the plasma can be supplied to the test strip. However, in the structure of dropping the filtered plasma to the test strip through the lower part of the cited invention, it is almost impossible to accurately supply the sample to the test strip in a horizontal state, so the invention has a fatal technical defect that cannot be put to practical use.
본 발명에서는 채혈기구를 여러 혈액검사기구들과 통합하여 밀폐된 공간 안에 모두 모아 넣는 방식과 함께, 일정한 부피의 혈액만을 제한된 공간 내에 안정하게 충만시키고, 충만된 혈액을 다중의 혈액검사기구의 검체공급부위들에만 제한적으로 동시에 일정량을 공급하는 방식을 취하여 상기의 기존 문제점들을 동시에 해결하고자 하였다.In the present invention, the blood collection apparatus is integrated with several blood test apparatuses, and together with the method of collecting all of them in a confined space, only a certain volume of blood is stably filled in a limited space, and the filled blood is supplied to a sample of multiple blood test apparatuses. To solve the above problems at the same time by taking a method of supplying a certain amount at the same time limited to only the parts.
본 발명의 장치를 사용할 경우 채혈과정 이후부터 검사완료까지 아무런 조작이 필요치 않아 래피드진단카드와 같은 기존의 검사기구에 비해서 더 빠르고 간편하며, 여러 혈액검사를 단일장치 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.When using the device 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 existing test apparatus such as a rapid diagnostic card, and it is inexpensive because several blood tests can be performed simultaneously in a single device. 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 장치 밖으로 전혀 노출되지 않으므로 질병의 이차감염이 방지됨과 동시에 채혈된 혈액의 공기접촉에서 오는 분석물질의 변형이나 습도변화로 인한 검사결과 오류도 방지할 수 있다.Since the collected blood is never exposed outside the device, the secondary infection of the disease is prevented and the test result error due to the deformation or humidity change of the analyte from the air contact of the collected blood can be prevented.
본 발명의 장치를 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 needed for another test immediately after starting blood collection and blood test using the device of the present invention, it is possible to draw as much as necessary by additionally connecting a vacuum blood vessel using a blood collection needle already plugged into a blood vessel. The pain in the blood collection subject can be minimized.
여러 혈액검사기구가 단일장치 내에 통합되어 있어 제조시 원가가 낮다.Several blood test instruments are integrated into a single device, resulting in low manufacturing costs.
종래 혈액검사기구는 포장파손으로 습기가 유입되어 제품성능이 저하되어도 인지가 불가능 하나 본 발명의 장치는 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 is impossible to recognize even if the product performance is degraded due to moisture invasion due to packaging damage, but the device of the present invention can be easily recognized because it is impossible to collect blood when the moisture is degraded due to damage. The performance of the instrument can always be guaranteed.
특히, 일정한 부피의 혈액만을 제한된 혈액실 공간 내에 중력의 역방향으로 안정하게 충만시킨 후, 충만되어 유동이 없는 상태의 혈액을 다중의 혈액검사기구들의 검체공급부위들에만 한정하여 동시에 일정량을 공급하는 방식을 취함으로써, 검사의 오류가 최소화되며 검사결과의 균일성과 안정성이 우수하다.In particular, after only a certain volume of blood is stably filled in a reversed direction of gravity in a limited blood chamber space, a method of supplying a certain amount of blood at the same time by confining blood in a state of being filled with no flow to only the sample supply sites of multiple blood test apparatuses By minimizing the error of inspection, the uniformity and stability of the inspection results are excellent.
또한 본 발명의 장치가 채혈 중에 옆으로 눕혀질 때나 채혈을 마치고 세워지면서 본 발명의 장치가 급격히 흔들릴 때에도 본 발명 특유의 유동이 없는 혈액실 구조의 특성으로 인하여 검사스트립의 작동에는 아무런 악영향이 없으므로 검사실패의 가능성이 없으며 사용편의성이 높다.In addition, even when the device of the present invention is lying on its side during blood collection or when the device of the present invention is suddenly shaken while standing after the blood collection, the test strip has no adverse effect on the operation of the test strip due to the characteristic of the blood chamber structure without the unique flow of the present invention. There is no possibility of failure and it is easy to use.
도 1 은 발명된 장치의 측면도이며 장치의 주요구조부분인 혈액유입관이 혈액차단체와 연결되는 부분의 단면도를 도면 왼쪽에 표시하였음.Figure 1 is a side view of the device invented and a cross-sectional view of a portion of the blood inlet pipe that is the main structural part of the device connected to the blood tea group is shown on the left side of the figure.
도 2 는 발명된 장치의 확장구조의 측면도이며 장치의 주요구조부분인 혈액유입관이 혈액차단체 및 혈구분리체와 각각 연결되는 부분의 단면도를 도면 왼쪽에 각각 표시하였음.Figure 2 is a side view of the expanded structure of the device of the present invention, the cross-sectional view of the portion of the blood inlet pipe, which is the main structural part of the device is connected to the blood tea group and blood cell separators, respectively, on the left side of the figure.
도 3 은 발명된 장치의 변형구조에 대한 측면도이며 장치의 주요구조부분인 혈액유입관의 단면도를 도면 왼쪽에 표시하였음.Figure 3 is a side view of a modified structure of the device of the invention 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.
본 발명의 장치에서는, 진공시험관과 같이 채혈을 위해 진공이 유지되는 밀폐용기 내부에 '도 1' 과 같이, 혈액유입관에 연결된 혈액실과 혈액차단체와 음압실을 순차적으로 설치하고, 이 혈액실에 단일 혹은 다중의 스트립 혹은 카드형 혈액검사기구들의 검체공급부위를 연결함으로써, 채혈기구와 검사기구를 하나의 밀폐공간에 밀집시킨다.In the apparatus of the present invention, a blood chamber connected to a blood inlet tube, a blood car group, and a negative pressure chamber are sequentially installed in a sealed container in which a vacuum is maintained for blood collection, such as a vacuum test tube. By connecting the sample supply section of single or multiple strips or card-type blood test apparatuses, the blood collection apparatus and test apparatus are concentrated in one confined space.
본 발명의 구조를 자세히 살펴보면, 채혈침이 결합되는 고무마개가 최상단부를 구성하고, 혈액유입관의 하부에 연결되어 있는 혈액실이 본 검사장치의 최하단부를 구성하며, 이 혈액실 바로 위쪽에 혈액유입관을 둘러싸는 고리형태로 음압실이 배치된다.Looking at the structure of the present invention in detail, the rubber stopper is coupled to the blood collection needle constitutes the top end, the blood chamber is connected to the lower portion of the blood inlet tube constitutes the lower end of the test device, the blood inlet tube just above the blood chamber The sound pressure chamber is arranged in the form of a surrounding ring.
혈액실과 음압실의 경계에는 혈액흡입에 방해가 되지 않게 공기가 유통되면서도 혈액 혹은 혈장 혹은 혈청은 유통되지 않도록, 소수성다공막 혹은 기공이 있는 격막 혹은 기공들이 있는 격막 혹은 플로트 밸브(Float Valve)가 설치된 기공이 있는 격막의 형태를 가진 혈액차단체가 설치된다.At the boundary between the blood chamber and the negative pressure chamber, a diaphragm or float valve with a hydrophobic porous membrane or pores or a diaphragm with pores is installed so that air and blood or plasma or serum are not distributed while preventing blood intake. A blood tea group in the form of pore diaphragms is installed.
검사에 사용되는 스트립 혹은 카드형 혈액검사기구는 혈액유입관의 외벽에 설치되며, 부착된 혈액검사기구들의 말단에 위치한 검체공급부위를 혈액차단체를 관통하여 혈액실로 직접 연결시키는 방식으로 채혈된 혈액을 검체공급부위로 전달하는 혈액전달구조물을 형성한다.The strip or card-type blood test apparatus used for the test is installed on the outer wall of the blood inlet tube, and the blood collected by directly connecting the sample supply site located at the distal end of the attached blood test apparatus to the blood chamber through the blood car group Form a blood delivery structure that delivers to the sample supply site.
"도 1"과 같은 구조에서 검사스트립 위에 혈구제거시트가 부착되어 있는 혈액검사기구를 설치하게 되면, 별도의 혈구제거과정을 거쳐 혈장을 공급하는 대신 전혈을 공급하더라도 혈액검사기능에 아무런 문제가 없다.In the structure as shown in FIG. 1, if a blood test apparatus having a blood cell removal sheet attached to the test strip is installed, there is no problem in blood test function even if whole blood is supplied instead of plasma through a separate blood cell removal process. .
본 발명의 확장으로써 "도 2" 와 같이 혈액실의 중간에 혈구를 분리할 수 있는 여과체 형태의 혈구분리체를 설치하여 검사스트립에 전혈 대신 혈장만을 공급할 수도 있다. 물론 이 경우에는 검사스트립 위에 혈구제거시트를 부착할 필요가 없다.As an extension of the present invention, as shown in FIG. 2, a blood cell separator in the form of a filter which can separate blood cells in the middle of the blood chamber may be installed to supply only plasma instead of whole blood to the test strip. In this case, of course, there is no need to attach the blood cell removal sheet on the test strip.
또한, 본 발명의 장치의 변형으로써 "도 3" 과 같이 별도의 음압실과 혈액차단체가 없이 채혈된 혈액을 직접 검체공급부위에 연결하는 형태의 구조 또한 가능하다.In addition, as a modification of the device of the present invention, as shown in FIG. 3, there is also a structure in which blood collected without a separate negative pressure chamber and blood difference unit is directly connected to the sample supply site.
본 발명의 장치는 감마선 등의 멸균과정을 거쳐 무균상태를 유지할 수 있다.The device of the present invention can maintain a sterile state through a sterilization process such as gamma rays.
본 발명의 장치의 작동과정을 살펴보면 아래와 같다.Looking at the operation of the device of the present invention.
먼저 검체 채취를 위하여 채혈침을 혈관에 삽입한 후 본 발명의 장치를 채혈침의 반대쪽에 연결하게 되면 채혈침 반대쪽의 침이 본 장치의 최상단에 위치한 고무마개를 관통하게 되는데, 이때 본 장치 내의 진공으로 인하여 채혈된 혈액이 혈액유입관을 통하여 혈액실의 하단으로 유입되며 혈액실을 채우게 된다.First, when the needle is inserted into a blood vessel for sampling, and the device of the present invention is connected to the opposite side of the needle, the needle on the opposite side of the needle penetrates the rubber stopper located at the top of the device. The blood flows to the bottom of the blood chamber through the blood inlet tube and fills the blood chamber.
혈액실이 차오르면 본 발명의 장치를 채혈침에서 분리하여 시험관 랙(Rack)에 끼워 수직으로 세워놓는다. 혈액실에 수집된 혈액은 혈액실로 돌출되어 나온 혈액검사기구들의 검체공급부위를 통하여 각 혈액검사기구로 공급되게 되며, 이때부터 각 혈액검사기구들에 의한 실제 혈액검사반응들이 시작되게 된다. When the blood chamber fills up, the device of the present invention is removed from the lancet and inserted into a test tube rack and placed vertically. Blood collected in the blood chamber is supplied to each blood test apparatus through sample supply sites of blood test apparatuses protruding into the blood chamber, from which the actual blood test reactions by the blood test apparatuses are started.
한편, 채혈과정에서 사람혈관에 채혈침을 지면과 수평에 가깝게 찔러 넣으므로 본 발명의 장치도 채혈침에 연결할 때 거의 지면과 수평하게 되는데, 이때 채혈된 혈액은 혈액차단체에 막혀서 검사스트립 본체로 흘러들어오지 못하고 안전하게 혈액실 내부에만 갇혀있게 되며 랙에 세우기 위해 검사장치를 회전시킬 때에도 혈액실 내부의 혈액의 요동은 완벽하게 방지되어 정확한 혈액검사를 수행한다.On the other hand, in the blood collection process, the needle is inserted into the human blood vessel horizontally close to the ground, so the device of the present invention is also almost horizontal to the ground when connected to the blood collection needle, and the collected blood is blocked by the blood group and flows into the test strip body. It can't be safely locked inside the blood chamber, and even when the test device is rotated to stand in a rack, blood fluctuations inside the blood chamber are completely prevented to perform accurate blood tests.
혈액검사 반응이 종료되면 본 발명의 장치의 투명한 외벽을 통하여 혈액검사기구 상에 보이는 혈액검사결과를 판독하게 된다.When the blood test reaction is completed, the blood test results displayed on the blood test apparatus are read through the transparent outer wall of the apparatus of the present invention.
결론적으로, 본 발명의 장치는 외부환경과 완전히 격리된 작은 공간 내에서 채혈과 동시에 여러 가지 혈액검사들을 즉석에서 안정적으로 실시할 수 있는 특징이 있으므로 각종 혈액검사시에 대단히 유용하게 쓰일 것으로 예상된다.In conclusion, the device 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 and at the same time stably in a small space completely isolated from the external environment.
또한 본 발명의 장치는 스트립 혹은 카드형태의 어떠한 소형 검사기구에도 검체를 자동으로 공급할 수 있기 때문에, 본 발명에 장착할 수 있는 혈액검사기구는 임신자가진단기와 같은 래피드진단카드 외에도 랩온어칩(Lab-on-a-chip) 등과 같은 여러 형태의 소형 혈액검사기구들이 될 수 있으므로 적용범위 또한 폭 넓다.In addition, since the device 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 on 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 can be many types of small blood test instruments such as on-a-chip.
본 발명의 장치의 대표적 적용사례로써, HBV,anti-HBV,HCV,HIV 의 4개의 래피드 진단스트립이 동시에 장착된 혈액검사장치를 들 수 있으며, 소변검사스트립과 유사한 형태로 건강검진시에 즉석혈액검사를 위해 사용될 것으로 예상된다. 이때 채혈침을 혈관에 삽입한 후 각종 검사를 위한 채혈관을 결합하여 필요한 혈액을 채취한 후 마지막에 본 발명의 장치를 채혈침에 다시 결합하여 위의 4종의 혈액검사를 동시에 실시간으로 실시하고 소변검사결과 판독과 유사하게 혈액검사결과를 즉석에서 판독하여 건강검진자에게 알려줄 수 있을 것으로 예상된다.Representative applications of the device of the present invention include a blood test device equipped with four rapid diagnostic strips of HBV, anti-HBV, HCV, and HIV at the same time. It is expected to be used for inspection. At this time, after inserting the blood collection needle into the blood vessels, the blood vessels for various tests are combined to collect the necessary blood, and finally, the device of the present invention is combined with the blood collection needles at the same time to perform the above four blood tests simultaneously 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.

Claims (8)

  1. 혈액실과 혈액차단체와 음압실이 장치 내에 연이어 배치되어 있으며, 장치 내에 형성되어 있는 음압에 의해 채혈된 혈액 혹은 혈장 혹은 혈청이 혈액실로 유입된 후 혈액차단체에 의해 혈액 혹은 혈장 혹은 혈청의 유입량이 제한되는 상태에서, 혈액실에 채워진 혈액 혹은 혈장 혹은 혈청이 혈액실에 연결된 한 개 이상의 혈액검사기구의 검체공급부에 공급되는 것을 특징으로 하는 혈액검사장치.Blood chambers, blood groups and negative pressure chambers are arranged in series in the device, and blood or plasma or serum collected by the negative pressure formed in the device flows into the blood chamber, and then blood, plasma, or serum In a limited state, the blood test device characterized in that the blood or plasma or serum filled in the blood chamber is supplied to the sample supply unit of one or more blood test apparatus connected to the blood chamber.
  2. 혈액실과 혈구분리체와 혈장실과 혈액차단체와 음압실이 장치 내에 연이어 배치되어 있으며, 장치 내에 형성되어 있는 음압에 의해 채혈된 혈액이 혈액실과 혈구분리체를 거쳐 혈장 혹은 혈청만으로 분리되어 혈장실로 유입된 후 혈액차단체에 의해 혈장 혹은 혈청유입량이 제한되는 상태에서, 혈장실에 채워진 혈장 혹은 혈청이 혈장실에 연결된 한 개 이상의 혈액검사기구의 검체공급부에 공급되는 것을 특징으로 하는 혈액검사장치.Blood chambers, blood cell separators, plasma chambers, blood groups and negative pressure chambers are arranged consecutively in the apparatus, and blood collected by the negative pressure formed in the apparatus is separated into plasma or serum through the blood chambers and blood cell separators and flows into the plasma chamber. The blood test apparatus, characterized in that the plasma or serum inflow is limited by the blood group, the plasma or serum is supplied to the sample supply unit of one or more blood test apparatus connected to the plasma room.
  3. 제1항에 있어서, 소수성다공막 혹은 기공이 있는 격막 혹은 기공들이 있는 격막 혹은 플로트 밸브(Float Valve)가 설치된 기공이 있는 격막을 혈액차단체로 설치하는 것을 특징으로 하는 혈액검사장치.The blood test apparatus according to claim 1, wherein a hydrophobic porous membrane, a diaphragm with pores, a diaphragm with pores, or a diaphragm with pores provided with a float valve is provided as a blood tea body.
  4. 제1항에 있어서, 채혈침과 혈액실을 연결하는 혈액유입관의 외벽에 1개 이상의 혈액검사기구를 설치하는 것을 특징으로 하는 혈액검사장치.The blood test apparatus according to claim 1, wherein at least one blood test apparatus is provided on an outer wall of the blood inflow pipe connecting the blood collection needle and the blood chamber.
  5. 제1항에 있어서, 혈액실에 연결되는 혈액검사기구를 피오씨티(Point of Care Test)진단키트로 하는 것을 특징으로 하는 혈액검사장치.The blood test apparatus according to claim 1, wherein the blood test apparatus connected to the blood chamber is a point of care test diagnostic kit.
  6. 제2항에 있어서, 소수성다공막 혹은 기공이 있는 격막 혹은 기공들이 있는 격막 혹은 플로트 밸브(Float Valve)가 설치된 기공이 있는 격막을 혈액차단체로 설치하는 것을 특징으로 하는 혈액검사장치.The blood test apparatus according to claim 2, wherein a hydrophobic porous membrane, a diaphragm with pores, a diaphragm with pores, or a diaphragm with pores provided with a float valve is provided as a blood difference unit.
  7. 제2항에 있어서, 채혈침과 혈액실을 연결하는 혈액유입관의 외벽에 1개 이상의 혈액검사기구를 설치하는 것을 특징으로 하는 혈액검사장치.The blood test apparatus according to claim 2, wherein at least one blood test apparatus is provided on an outer wall of the blood inflow pipe connecting the blood collection needle and the blood chamber.
  8. 제2항에 있어서, 혈장실에 연결되는 혈액검사기구를 피오씨티(Point of Care Test)진단키트로 하는 것을 특징으로 하는 혈액검사장치.The blood test apparatus according to claim 2, wherein the blood test apparatus connected to the plasma chamber is a point of care test diagnostic kit.
PCT/KR2009/001588 2009-03-30 2009-03-30 Blood testing kit having suction type sampling equipment which collects a predetermined volume of blood WO2010114183A1 (en)

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Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN103829957A (en) * 2012-11-22 2014-06-04 白杰 Double-needle plug-piercing system of instant vacuum blood collection device
CN113110677A (en) * 2021-05-27 2021-07-13 广东工业大学 Low-power-consumption negative pressure generator for radio frequency switch

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JPH05188053A (en) * 1992-01-10 1993-07-27 Sanwa Kagaku Kenkyusho Co Ltd Instrument for separating serum or plasma component from blood
JP2001321366A (en) * 2000-05-16 2001-11-20 Fuji Photo Film Co Ltd Plasma or serum taking tool
JP2005009888A (en) * 2003-06-16 2005-01-13 Sekisui Chem Co Ltd Vessel for blood test and blood testing method
JP2007006973A (en) * 2005-06-28 2007-01-18 Sekisui Chem Co Ltd Blood sampling and separating apparatus

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Publication number Priority date Publication date Assignee Title
JPH05188053A (en) * 1992-01-10 1993-07-27 Sanwa Kagaku Kenkyusho Co Ltd Instrument for separating serum or plasma component from blood
JP2001321366A (en) * 2000-05-16 2001-11-20 Fuji Photo Film Co Ltd Plasma or serum taking tool
JP2005009888A (en) * 2003-06-16 2005-01-13 Sekisui Chem Co Ltd Vessel for blood test and blood testing method
JP2007006973A (en) * 2005-06-28 2007-01-18 Sekisui Chem Co Ltd Blood sampling and separating apparatus

Cited By (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN103829957A (en) * 2012-11-22 2014-06-04 白杰 Double-needle plug-piercing system of instant vacuum blood collection device
CN113110677A (en) * 2021-05-27 2021-07-13 广东工业大学 Low-power-consumption negative pressure generator for radio frequency switch
CN113110677B (en) * 2021-05-27 2022-05-27 广东工业大学 Low-power-consumption negative pressure generator for radio frequency switch
US11711075B2 (en) 2021-05-27 2023-07-25 Guangdong University Of Technology Low-power consumption negative voltage generator for radio frequency switches

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