JPH0334723B2 - - Google Patents
Info
- Publication number
- JPH0334723B2 JPH0334723B2 JP61029394A JP2939486A JPH0334723B2 JP H0334723 B2 JPH0334723 B2 JP H0334723B2 JP 61029394 A JP61029394 A JP 61029394A JP 2939486 A JP2939486 A JP 2939486A JP H0334723 B2 JPH0334723 B2 JP H0334723B2
- Authority
- JP
- Japan
- Prior art keywords
- calibration
- tube
- blood
- heparinized
- sample
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Expired - Lifetime
Links
- 239000008280 blood Substances 0.000 claims description 101
- 210000004369 blood Anatomy 0.000 claims description 101
- 238000005259 measurement Methods 0.000 claims description 46
- 235000013305 food Nutrition 0.000 claims description 33
- FAPWRFPIFSIZLT-UHFFFAOYSA-M Sodium chloride Chemical compound [Na+].[Cl-] FAPWRFPIFSIZLT-UHFFFAOYSA-M 0.000 claims description 15
- 239000011780 sodium chloride Substances 0.000 claims description 15
- 239000000126 substance Substances 0.000 claims description 8
- 239000007788 liquid Substances 0.000 claims description 7
- 238000010790 dilution Methods 0.000 description 36
- 239000012895 dilution Substances 0.000 description 36
- 238000010241 blood sampling Methods 0.000 description 24
- 239000012086 standard solution Substances 0.000 description 16
- 238000000691 measurement method Methods 0.000 description 15
- WQZGKKKJIJFFOK-GASJEMHNSA-N Glucose Natural products OC[C@H]1OC(O)[C@H](O)[C@@H](O)[C@@H]1O WQZGKKKJIJFFOK-GASJEMHNSA-N 0.000 description 7
- 239000003085 diluting agent Substances 0.000 description 7
- 239000008103 glucose Substances 0.000 description 7
- 238000000034 method Methods 0.000 description 7
- 238000007796 conventional method Methods 0.000 description 6
- 238000004458 analytical method Methods 0.000 description 4
- 239000002699 waste material Substances 0.000 description 4
- 239000012482 calibration solution Substances 0.000 description 3
- IJGRMHOSHXDMSA-UHFFFAOYSA-N Atomic nitrogen Chemical compound N#N IJGRMHOSHXDMSA-UHFFFAOYSA-N 0.000 description 2
- 102000004190 Enzymes Human genes 0.000 description 2
- 108090000790 Enzymes Proteins 0.000 description 2
- WQZGKKKJIJFFOK-VFUOTHLCSA-N beta-D-glucose Chemical compound OC[C@H]1O[C@@H](O)[C@H](O)[C@@H](O)[C@@H]1O WQZGKKKJIJFFOK-VFUOTHLCSA-N 0.000 description 2
- 238000004159 blood analysis Methods 0.000 description 2
- DDRJAANPRJIHGJ-UHFFFAOYSA-N creatinine Chemical compound CN1CC(=O)NC1=N DDRJAANPRJIHGJ-UHFFFAOYSA-N 0.000 description 2
- 230000000694 effects Effects 0.000 description 2
- NOESYZHRGYRDHS-UHFFFAOYSA-N insulin Chemical compound N1C(=O)C(NC(=O)C(CCC(N)=O)NC(=O)C(CCC(O)=O)NC(=O)C(C(C)C)NC(=O)C(NC(=O)CN)C(C)CC)CSSCC(C(NC(CO)C(=O)NC(CC(C)C)C(=O)NC(CC=2C=CC(O)=CC=2)C(=O)NC(CCC(N)=O)C(=O)NC(CC(C)C)C(=O)NC(CCC(O)=O)C(=O)NC(CC(N)=O)C(=O)NC(CC=2C=CC(O)=CC=2)C(=O)NC(CSSCC(NC(=O)C(C(C)C)NC(=O)C(CC(C)C)NC(=O)C(CC=2C=CC(O)=CC=2)NC(=O)C(CC(C)C)NC(=O)C(C)NC(=O)C(CCC(O)=O)NC(=O)C(C(C)C)NC(=O)C(CC(C)C)NC(=O)C(CC=2NC=NC=2)NC(=O)C(CO)NC(=O)CNC2=O)C(=O)NCC(=O)NC(CCC(O)=O)C(=O)NC(CCCNC(N)=N)C(=O)NCC(=O)NC(CC=3C=CC=CC=3)C(=O)NC(CC=3C=CC=CC=3)C(=O)NC(CC=3C=CC(O)=CC=3)C(=O)NC(C(C)O)C(=O)N3C(CCC3)C(=O)NC(CCCCN)C(=O)NC(C)C(O)=O)C(=O)NC(CC(N)=O)C(O)=O)=O)NC(=O)C(C(C)CC)NC(=O)C(CO)NC(=O)C(C(C)O)NC(=O)C1CSSCC2NC(=O)C(CC(C)C)NC(=O)C(NC(=O)C(CCC(N)=O)NC(=O)C(CC(N)=O)NC(=O)C(NC(=O)C(N)CC=1C=CC=CC=1)C(C)C)CC1=CN=CN1 NOESYZHRGYRDHS-UHFFFAOYSA-N 0.000 description 2
- JVTAAEKCZFNVCJ-UHFFFAOYSA-N lactic acid Chemical compound CC(O)C(O)=O JVTAAEKCZFNVCJ-UHFFFAOYSA-N 0.000 description 2
- OYPRJOBELJOOCE-UHFFFAOYSA-N Calcium Chemical compound [Ca] OYPRJOBELJOOCE-UHFFFAOYSA-N 0.000 description 1
- DGAQECJNVWCQMB-PUAWFVPOSA-M Ilexoside XXIX Chemical compound C[C@@H]1CC[C@@]2(CC[C@@]3(C(=CC[C@H]4[C@]3(CC[C@@H]5[C@@]4(CC[C@@H](C5(C)C)OS(=O)(=O)[O-])C)C)[C@@H]2[C@]1(C)O)C)C(=O)O[C@H]6[C@@H]([C@H]([C@@H]([C@H](O6)CO)O)O)O.[Na+] DGAQECJNVWCQMB-PUAWFVPOSA-M 0.000 description 1
- 102000004877 Insulin Human genes 0.000 description 1
- 108090001061 Insulin Proteins 0.000 description 1
- ZLMJMSJWJFRBEC-UHFFFAOYSA-N Potassium Chemical compound [K] ZLMJMSJWJFRBEC-UHFFFAOYSA-N 0.000 description 1
- XSQUKJJJFZCRTK-UHFFFAOYSA-N Urea Chemical compound NC(N)=O XSQUKJJJFZCRTK-UHFFFAOYSA-N 0.000 description 1
- LEHOTFFKMJEONL-UHFFFAOYSA-N Uric Acid Chemical compound N1C(=O)NC(=O)C2=C1NC(=O)N2 LEHOTFFKMJEONL-UHFFFAOYSA-N 0.000 description 1
- TVWHNULVHGKJHS-UHFFFAOYSA-N Uric acid Natural products N1C(=O)NC(=O)C2NC(=O)NC21 TVWHNULVHGKJHS-UHFFFAOYSA-N 0.000 description 1
- 230000032683 aging Effects 0.000 description 1
- 239000012503 blood component Substances 0.000 description 1
- 238000009534 blood test Methods 0.000 description 1
- 239000011575 calcium Substances 0.000 description 1
- 229910052791 calcium Inorganic materials 0.000 description 1
- 229960005069 calcium Drugs 0.000 description 1
- 239000004202 carbamide Substances 0.000 description 1
- 230000001112 coagulating effect Effects 0.000 description 1
- 239000000306 component Substances 0.000 description 1
- 238000011109 contamination Methods 0.000 description 1
- 229940109239 creatinine Drugs 0.000 description 1
- 230000006866 deterioration Effects 0.000 description 1
- 206010012601 diabetes mellitus Diseases 0.000 description 1
- 235000005911 diet Nutrition 0.000 description 1
- 230000037213 diet Effects 0.000 description 1
- 238000007598 dipping method Methods 0.000 description 1
- 239000003814 drug Substances 0.000 description 1
- 239000003792 electrolyte Substances 0.000 description 1
- 229940037395 electrolytes Drugs 0.000 description 1
- 238000005516 engineering process Methods 0.000 description 1
- 235000014106 fortified food Nutrition 0.000 description 1
- 239000012634 fragment Substances 0.000 description 1
- 229940125396 insulin Drugs 0.000 description 1
- 238000010409 ironing Methods 0.000 description 1
- 208000017169 kidney disease Diseases 0.000 description 1
- 235000014655 lactic acid Nutrition 0.000 description 1
- 239000004310 lactic acid Substances 0.000 description 1
- 208000019423 liver disease Diseases 0.000 description 1
- 230000007774 longterm Effects 0.000 description 1
- 239000012528 membrane Substances 0.000 description 1
- 229910052751 metal Inorganic materials 0.000 description 1
- 239000002184 metal Substances 0.000 description 1
- 229960005419 nitrogen Drugs 0.000 description 1
- 229910052757 nitrogen Inorganic materials 0.000 description 1
- 210000000496 pancreas Anatomy 0.000 description 1
- 230000002093 peripheral effect Effects 0.000 description 1
- 229910052700 potassium Inorganic materials 0.000 description 1
- 239000011591 potassium Substances 0.000 description 1
- 238000005086 pumping Methods 0.000 description 1
- 238000000926 separation method Methods 0.000 description 1
- 229910052708 sodium Inorganic materials 0.000 description 1
- 239000011734 sodium Substances 0.000 description 1
- 238000001356 surgical procedure Methods 0.000 description 1
- 230000001225 therapeutic effect Effects 0.000 description 1
- 229940045136 urea Drugs 0.000 description 1
- 229940116269 uric acid Drugs 0.000 description 1
- 210000003462 vein Anatomy 0.000 description 1
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 description 1
Description
【発明の詳細な説明】
〔産業上の利用分野〕
本発明は、連続採血サンプルの特定物質の濃度
を測定する装置に関する。DETAILED DESCRIPTION OF THE INVENTION [Field of Industrial Application] The present invention relates to an apparatus for measuring the concentration of a specific substance in continuously collected blood samples.
血液成分分析は、現代医学の進歩に伴い医学治
療の観点から、ますますその重要性は高まつてい
る。一般電解質としてのナトリウム、カリウム、
カルシウムや、腎疾患における尿素、窒素、クレ
アチニン、尿酸、肝疾患におけるGOT、GPT、
糖尿病あるいは外科手術における血糖値としての
グルコースあるいは乳酸等々、数多くの血液検査
が行なわれている。これらの特定物質の測定にお
いては、採血サンプルである血液の一定量を採血
器により採血して測定する頻回測定法と、採血サ
ンンプルである血液の一定量を連続的に採血して
測定する連続側定法とがある。頻度測定法であ
れ、連続測定法であれ、正確な測定値を得るため
には、測定センサあるいは測定系の校正が必要で
ある。校正は通常、零点および勾配（直線性）の
校正である頻回測定法の場合には、測定のたびご
とに校正を行なうのが普通あるが、連続測定法の
場合には、ある一定時間間隔で校正しなければな
らない。そのため、頻回測定法と連続測定法とで
は自ずと校正方法が違つてくる。本発明において
は、連続測定法が対象である。連続測定法におい
て、以下内部校正と外部校正とに分けて説明す
る。ここでは、内部校正とは、測定センサの校
正、外部校正とは、測定センサを除き、採血針の
穿刺による誤差の校正および採血部位ならびにチ
ユーブ類の経時変化の校正と定める。
Blood component analysis is becoming increasingly important from the perspective of medical treatment with the advancement of modern medicine. Sodium, potassium as general electrolytes,
Calcium, urea, nitrogen, creatinine, uric acid in kidney disease, GOT, GPT in liver disease,
Many blood tests are performed, such as glucose or lactic acid for blood sugar levels during diabetes or surgical procedures. In the measurement of these specific substances, there is a frequent measurement method in which a fixed amount of blood is collected using a blood sampler and measured, and a continuous measurement method in which a fixed amount of blood is continuously collected and measured. There is a side law. Whether using a frequency measurement method or a continuous measurement method, the measurement sensor or measurement system must be calibrated in order to obtain accurate measurement values. Calibration is usually zero point and slope (linearity) calibration.In the case of a frequent measurement method, calibration is usually performed every time a measurement is made, but in the case of a continuous measurement method, it is performed at a certain time interval. must be proofread. Therefore, the calibration methods are naturally different between the frequent measurement method and the continuous measurement method. In the present invention, a continuous measurement method is targeted. In the continuous measurement method, internal calibration and external calibration will be explained separately below. Here, the internal calibration is defined as the calibration of the measurement sensor, and the external calibration is defined as the calibration of errors caused by puncturing the blood sampling needle and the calibration of changes over time of the blood sampling site and tubes, excluding the measurement sensor.
頻回測定法におては、その都度、採血した採血
サンプルを適宜希釈し、所定の測定センサで測定
するのでああるるから、上記のごとく測定センサ
の校正が正確に行なわれていれば穿刺やチユーブ
類の校正は必要ない。しかるに、連続測定法にお
いては、内部校正である測定センサでの校正だけ
でなく、外部校正が必要である。ひとつは採血針
を穿刺したときの生体組織の圧力によるカテーテ
ルの変形およびその経時変化、もうひとつは採血
部位の動きにより、カテーテルの入り口先端が組
織と接触して部分的に閉塞されたり、組織片がひ
つかかつたりすることによる血液の吸引のしやす
さの経時的変化およびチユーブ類のポンプのしご
きによる形状や弾性の経時変化である。これらの
変化によりそれぞれの流量が変化し、他の液との
混合比や希釈率が経時的に変化し、測定値が正し
い値を示さなくなる。 In the frequent measurement method, the blood sample is appropriately diluted each time and measured with a predetermined measurement sensor, so if the measurement sensor is accurately calibrated as described above, puncture There is no need to calibrate tubes or tubes. However, in the continuous measurement method, not only internal calibration at the measurement sensor but also external calibration is required. One is the deformation of the catheter due to the pressure of the living tissue when the blood collection needle is inserted, and its changes over time.The other is the movement of the blood collection site, which may cause the entrance tip of the catheter to come into contact with tissue and become partially occluded, or tissue fragments may form. Changes over time in the ease with which blood can be sucked due to tightening and twisting of tubes, and changes over time in the shape and elasticity of tubes due to pumping. These changes cause the respective flow rates to change, the mixing ratio with other liquids and the dilution rate to change over time, and the measured values no longer show correct values.
従つて正しい測定のためには外部校正が必要で
ある。現在、これまで述べてきた校正の内、内部
校正により測定センサの校正をできるようにした
ものはあるが、外部校正が完全にできるものでは
ない。特公昭58−11018は、まさに「センサの較
正用装置」を提供するものであるが、外部校正は
全く考慮されれておらず特開昭52−135795号も外
部校正については何も考えていない。 External calibration is therefore required for correct measurements. Currently, among the calibrations described so far, there are some that allow measurement sensors to be calibrated by internal calibration, but external calibration is not completely possible. Japanese Patent Publication No. 58-11018 provides a ``device for calibrating sensors,'' but external calibration is not considered at all, and Japanese Patent Publication No. 135795/1982 does not consider anything about external calibration. .
特開昭57−17851号は一部のしごきチユーブの
変化に対する考慮はみられるが、充分ではなく、
また採血部の変化に関してはまつたく考慮されて
いない。したがつて、連続測定法におかる大きな
問題が残されたままである。 Although JP-A No. 17851/1985 does take into account some changes in the ironing tube, it is not sufficient.
Also, changes in the blood sampling area have not been taken into consideration. Therefore, major problems with continuous measurement methods remain.
測定センサらびにその測定系は、まず、校正用
サンプルとして標準液あるいは別に採血した採血
サンプルを使つて、零ならびに勾配（直線性）の
校正が必要である。通常、標準液を用いることが
多い。
The measurement sensor and its measurement system must first be calibrated for zero and slope (linearity) using a standard solution or a separately collected blood sample as a calibration sample. Usually, a standard solution is often used.
この校正は、標準液を入れた容器の中へ採血針
を浸し、標準液を吸引して行なう。採血針として
は、採血直後に血液が凝固しないように、ヘパリ
ン加生食水により血液を希釈する構造を有するダ
ブルル−メン・カテーテルが使われる。上記の校
正を行なつた後、採血針を生体に穿刺した場合、
圧力状態の変化により、血液とヘパリン加生食水
との希釈率に変化を生じ、その結果、測定値に誤
差を生じる。 This calibration is performed by dipping the blood collection needle into a container containing a standard solution and aspirating the standard solution. As the blood collection needle, a double lumen catheter is used which has a structure that dilutes blood with heparinized saline to prevent blood from coagulating immediately after blood collection. After performing the above calibration, when a blood collection needle is inserted into a living body,
A change in the pressure state causes a change in the dilution ratio between blood and heparinized saline, resulting in an error in the measured value.
もうひとつの問題は、採血部位の経時的変化な
らびに採血チユーブ、ヘパリン加生食チユーブ、
および希釈チユーブの経時変化である。採血部位
の体位の変化により、採血部位に経時的な物理的
変化を生ずる。また、採血チユーブ、ヘパリン加
生食チユーブおよび希釈チユーブは、採血ならび
に希釈のためのしごきポンプにより経時的なヘた
りを生ずる。 Another problem is changes over time in the blood sampling site, blood sampling tube, heparinized food tube,
and the change over time in the dilution tube. Changes in the body position of the blood collection site cause physical changes in the blood collection site over time. In addition, blood collection tubes, heparinized food tubes, and dilution tubes wear out over time due to the straining pumps used for blood collection and dilution.
これらの経時的な変化により、血液とヘパリリ
ン加生食水との希釈率、あるいは測定直前に行な
われる２次希釈の希釈率に変動を生じ、その結果
測定値に誤差となつて現われる。 These changes over time cause variations in the dilution ratio between blood and heparin-added saline, or in the dilution ratio of secondary dilution performed immediately before measurement, resulting in errors in the measured values.
これまで述べてきた連続測定法における問題点
については、何ら具体策がとられていないのが実
情である。
The reality is that no concrete measures have been taken to address the problems with the continuous measurement method described above.
本発明者らは、鋭意検討を重ねて本発明に到達
したものであり、連続採血サンプルの特定物質濃
度を測定するに当たり、採血時の穿刺による誤差
ならびに採血部位、採血チユーブ、ヘパリン加生
食チユーブおよび希釈チユーブの経時変化を校正
することが可能な装置を提供することを目的とす
る。 The present inventors have arrived at the present invention through extensive studies, and in measuring the concentration of a specific substance in continuous blood samples, there are no errors caused by puncturing during blood sampling, blood sampling site, blood sampling tube, heparinized food tube, and the like. It is an object of the present invention to provide an apparatus capable of calibrating changes over time in a dilution tube.
上記採血時の穿刺による誤差、ならびに採血部
位、採血チユーブ、ヘパリン加生食チユーブおよ
び希釈チユーブの経時変化を校正するに当たつ
て、校正のための穿刺のやり直し、あるいは採血
チユーブ、ヘパリン加生食チユーブおよび希釈チ
ユーブ等の着脱は行なわずに校正することが不可
欠である。また、校正中に連続採血サンプルを廃
棄することは全く無意味なことであり、校正中は
連続採血を停止することが望ましい。
In order to calibrate the above-mentioned puncturing errors during blood sampling, as well as changes over time in the blood sampling site, blood sampling tube, heparinized food tube, and dilution tube, it is necessary to redo the puncture for calibration, or to calibrate the blood sampling tube, heparinized food tube, and dilution tube. It is essential to calibrate without attaching or detaching dilution tubes, etc. Furthermore, it is completely pointless to discard continuous blood sampling during calibration, and it is desirable to stop continuous blood sampling during calibration.
以上を考慮した本発明は、連続採血サンプルを
測定センサに導いて連続採血サンプル中の特定物
質濃度を測定する装置において、採血チユーブと
ヘパリン加生食チユーブの、ダブルルーメンカテ
ーテルと採血ポンプの間の部分に、それぞれ校正
用チユーブと校正用ヘパリン加生食チユーブを分
岐接続するとともに、採血チユーブと校正用チユ
ーブとの、またヘパリン加生食チユーブと校正用
ヘパリン加生食チユーブとの間の流路切り替え手
段をそれぞれ設け、さらに校正用チユーブと校正
用ヘパリン加生食チユーブの他端に他のダブルル
ーメンカテーテルを連結させることにより、測定
センサに導く液体を採血サンプルから校正サンプ
ルにに切り替えて測定もしくは校正できるように
した連続採血サンプルの特定物質濃度測定装置で
ある。 In consideration of the above, the present invention provides a device for measuring the concentration of a specific substance in continuously collected blood samples by guiding the continuously collected blood samples to a measurement sensor, in which the portion between the blood collection tube and the heparinized food tube is located between the double lumen catheter and the blood collection pump. The calibration tube and the heparinized food tube for calibration are each branch-connected, and flow path switching means are provided between the blood collection tube and the calibration tube, and between the heparinized food tube and the heparinized food tube for calibration. By connecting another double lumen catheter to the other end of the calibration tube and the heparinized tube for calibration, it became possible to switch the liquid introduced to the measurement sensor from the blood sample to the calibration sample for measurement or calibration. This is a device for measuring the concentration of specific substances in continuous blood samples.
測定中、採血チユーブには一定量の連続採血サ
ンプルが流れており、一方、ヘパリリン加生食水
は所定の希釈率になる量が流れている。
During measurement, a constant amount of continuously collected blood sample is flowing into the blood collection tube, while an amount of heparin-added saline is flowing at a predetermined dilution rate.
ダブルルーメンカテーテルでは、測定に充分な
だけの連続採血サンプルの希釈率がとれないた
め、測定センサの直前でさらに希釈する必要があ
る。これが２次希釈である。２次希釈により所定
の希釈率に希釈された後、測定センサで測定され
る。 With a double lumen catheter, it is not possible to dilute the continuously collected blood sample sufficiently for measurement, so it is necessary to further dilute the sample immediately before the measurement sensor. This is the secondary dilution. After being diluted to a predetermined dilution rate by secondary dilution, it is measured by a measurement sensor.
校正を行なう場合には、採血チユーブとヘパリ
ン加生食チユーブに外部から校正用チユーブと校
正用ヘパリン加生食チユーブとをそれぞれ接続
し、採血チユーブとヘパリン加生食チユーブの流
路を該校正用チユーブと校正用ヘパンン加生食チ
ユーブの流路に切り替えることによつて、外部に
用意した標準液あるいは採血サンプルを所定の希
釈率に希釈し、これをさらに２次希釈した後、測
定センサで測定して校正を行なう。校正は校正器
（図示せず）で行なう。この際、連続採血は停止
するのが好ましい。 When performing calibration, connect the calibration tube and heparinized food tube from the outside to the blood collection tube and heparinized food tube, respectively, and calibrate the flow paths of the blood collection tube and heparinized food tube with the calibration tube. By switching to the flow path of the hepan-enriched food tube, an externally prepared standard solution or blood sample is diluted to a predetermined dilution rate, which is further diluted, and then measured with a measurement sensor for calibration. Let's do it. Calibration is performed using a calibrator (not shown). At this time, it is preferable to stop continuous blood collection.
以上のごとく、校正に当たつて、穿刺した状態
で採血チユーブおよびヘパリン加生食チユーブの
着脱を行なうことなく、採血チユーブとヘパリン
加生食チユーブそれぞれの流路を校正用チユーブ
と校正用ヘパリン加生食チユーブの流路に切り替
え、標準液もしくは別途採取した血液サンプルを
使用して校正することによつて、採血針、即ちダ
ブルルーメン・カテーテルの穿刺による誤差およ
び穿刺部位の経時変化、さらびに採血チユーブヘ
パリン加生食チユーブおよび希釈チユーブの経時
変化を校正できる。 As described above, during calibration, the flow paths of the blood collection tube and the heparinized food tube are connected to the calibration tube and the heparinized food tube for calibration without having to attach and detach the blood collection tube and the heparinized food tube in the punctured state. By switching to the flow path of It is possible to calibrate changes over time in saline tubes and diluted tubes.
これによつて、従来より高精度の校正が可能と
なり、測定値の精度は一段と向上される。特に経
時変化の校正は、長期の連続測定法において効果
が大きい。 This makes it possible to perform calibration with higher precision than in the past, and the precision of measured values is further improved. Calibration of changes over time is particularly effective in long-term continuous measurement methods.
穿刺による誤差、ならびに採血部位、採血チユ
ーブ、ヘパリン加生食チユーブおよび希釈チユー
ブの経時変化はそのときの条件によつて異なり、
種々の組み合わせの変化を生ずるが、どのような
状態の組み合わせであつても、本発明にかかわる
装置によつて校正が可能である。 Errors caused by puncturing and changes over time in the blood collection site, blood collection tube, heparinized food tube, and dilution tube vary depending on the conditions at that time.
Various combinations of changes occur, but any combination of conditions can be calibrated by the apparatus according to the present invention.
以下図面に従つて、実施の態様を詳細に説明す
る。
Embodiments will be described in detail below with reference to the drawings.
第１図は本発明にかかわるフロー図、第２図は
従来方法によるフロー図である。第１図と第２図
において共通なものは、同一符号を用いている。 FIG. 1 is a flowchart according to the present invention, and FIG. 2 is a flowchart according to a conventional method. Components common to FIG. 1 and FIG. 2 are designated by the same reference numerals.
第２図において、まずあらかじめ別の手段によ
り（後述）、測定センサ５０の零を定める。次い
で、採血ポンプ３２により、校正用サンプル２３
として標準液を採血針であるダブルルーメン・カ
テーテル１０から吸引し、該標準液をヘパリン加
生食容器１６に入つたヘパリン加生食水１８で希
釈し、続いて希釈ポンプ３４により２次希釈を行
ない、混合コイル４６で混合し、気泡分離器４８
で気泡分離を行なつた後、測定センサ５０で測定
された校正値が得られる。この校正は通常、２種
の濃度の標準液で行なう２点校正法が好ましい。 In FIG. 2, first, the zero of the measurement sensor 50 is determined in advance by another means (described later). Next, the blood collection pump 32 collects the calibration sample 23.
Aspirate the standard solution from the double lumen catheter 10 which is a blood collection needle, dilute the standard solution with heparinized saline 18 contained in the heparinized saline container 16, and then perform secondary dilution with the dilution pump 34, Mixed by mixing coil 46 and bubble separator 48
After performing bubble separation in , a calibration value measured by the measurement sensor 50 is obtained. A two-point calibration method in which standard solutions of two concentrations are used for this calibration is usually preferred.
ここまでの校正を行なつた段階で、ダブルルー
メン・カテーテル１０を穿刺し採血を開始する。
連続採血サンプルは、上記校正時と同じ要領で希
釈され、測定センサ５０で測定値が得られる。こ
のようにして測定される従来方法では、ダブルル
ーメン・カテーテル１０の穿刺による誤差、ま
た、連続測定における採血ポンプ３２および希釈
ポンプ３４により、採血チユーブ１２、ヘパリリ
ン加生食チユーブ１４および希釈チユーブ３６に
ヘたりを生じ、それぞれの希釈率が経時的に変化
し、目的の測定値はかなり精度の低いものとな
る。 Once the calibration has been performed up to this point, the double lumen catheter 10 is punctured and blood collection begins.
The continuously collected blood sample is diluted in the same manner as in the above calibration, and a measurement value is obtained by the measurement sensor 50. In the conventional method of measuring in this way, errors due to puncturing of the double lumen catheter 10 and blood sampling pump 32 and dilution pump 34 in continuous measurement cause blood to be transferred to the blood sampling tube 12, heparinized saline tube 14 and dilution tube 36. As a result, the respective dilution rates change over time, making the desired measurement value considerably less accurate.
そこで、本発明においては、第１図のごとく切
替器２８，３０を介して、校正チユーブ２４と校
正用ヘパリン加生食チユーブ２６および採血針２
２とを、採血チユーブ１２とヘパリン加生食チユ
ーブ１４にそれぞれ接続しておく、また、上記以
外は、第１図と第２図とは同じである。内部校正
法も第１図と第２図と同じである。 Therefore, in the present invention, the calibration tube 24, the calibration heparinized saline tube 26, and the blood sampling needle 2 are
2 are connected to the blood collection tube 12 and the heparinized food tube 14, respectively.Other than the above, FIG. 1 and FIG. 2 are the same. The internal calibration method is also the same as in FIGS. 1 and 2.
ダブルルーメン・カテーテル１０から一定量の
連続採血サンプルが採血ポンプ３２により採血さ
れ、ダブルルーメン・カテーテル１０でヘパリン
加生食水１８により約５倍に希釈される。希釈さ
れた採血サンプルは、採血ポンプ３２で混合器４
４へ送られ、いつぽう、希釈液溶器３８に入れら
れた希釈液４０は希釈ポンプ３４で吸引され、希
釈チユーブ３６を経て混合器４４へ導びかれる。
混合器４４でさらに５〜６倍に２次希釈された連
続採血サンプルは、混合コイル４６、気泡分離器
４８を経て測定センサ５０で測定される。希釈さ
れた連続採血サンプルは、廃液チユーブ５２から
廃液容器５４へ廃液される。なお、４２は気泡混
入チユーブである。 A constant amount of blood sample is continuously collected from the double lumen catheter 10 by a blood collection pump 32, and diluted approximately five times with heparinized saline 18 in the double lumen catheter 10. The diluted blood sample is transferred to a mixer 4 using a blood collection pump 32.
The diluent 40 which is sent to the diluent tube 4 and placed in the diluent dispenser 38 is sucked by the dilution pump 34 and guided to the mixer 44 via the dilution tube 36.
The continuously collected blood sample, which is further diluted 5 to 6 times in the mixer 44, passes through the mixing coil 46, the bubble separator 48, and is measured by the measurement sensor 50. The diluted continuous blood sample is drained from the waste tube 52 into the waste container 54 . Note that 42 is a bubble-containing tube.
このようにして測定される従来方法では、先に
述べたように、ひとつはダブルルーメン・カテー
テル１０を校正用サンプルで外部で校正した時
と、実際に穿刺した時との物理的条件に起因する
ダブルルーメン・カテーテル１０内の希釈率が変
化し、測定値の精度が低い。もうひとつは、採血
部位の経時変化と採血ポンプ３２および希釈ポン
プ３４のしごきによる採血チユーブ１２、ヘパリ
ン加生食チユーブ１４および希釈チユーブ３６の
へたりであり、その結果希釈率が変化し、測定値
の精度が悪化する。 In the conventional method of measuring in this way, as mentioned earlier, one reason is due to the physical conditions between when the double lumen catheter 10 was calibrated externally with a calibration sample and when it was actually punctured. The dilution rate within the double lumen catheter 10 varies and the accuracy of the measurements is low. The other reason is that the blood collection tube 12, heparinized food tube 14, and dilution tube 36 become worn down due to changes over time at the blood collection site and straining of the blood collection pump 32 and dilution pump 34. As a result, the dilution rate changes and the measured values change. Accuracy deteriorates.
そこで本発明の装置の使用にあたつては任意の
時間に次のように校正する。まず、ダブルルーメ
ン・カテーテル２２を、校正用サンプル２３へ浸
漬する。初めに、ダブルルーメン・カテーテル２
２を校正用サンプル２３としての標準液へ浸漬す
る。これによつて、採血部位の経時変化と採血チ
ユーブ１２、ヘパリン加生食チユーブ１４および
希釈チユーブ３６の経時的なへたりを校正する。
次に、校正用サンプル２３として別に採取した採
血サンプルを使用する。これによつて、穿刺した
時と穿刺しない時の誤差を校正する。もちろん、
校正用サンプル２３である標準液あるいは採血サ
ンプルは採血ポンプ３２で吸引され、ヘパリン加
生食水１８により希釈され、希釈ポンプ３４で吸
引される希釈液４０で２次希釈された後、測定セ
ンサ５０で測定され、校正される。 Therefore, when using the apparatus of the present invention, calibration is performed at any time as follows. First, the double lumen catheter 22 is immersed in the calibration sample 23. First, double lumen catheter 2
2 is immersed in a standard solution as a calibration sample 23. This calibrates changes in the blood collection site over time and wear-out of the blood collection tube 12, heparinized food tube 14, and dilution tube 36 over time.
Next, a separately collected blood sample is used as the calibration sample 23. This calibrates the error when puncturing and not puncturing. of course,
A standard solution or a blood sample, which is a calibration sample 23, is sucked in by a blood sampling pump 32, diluted with heparinized saline 18, and secondarily diluted with a diluent 40 sucked in by a dilution pump 34. Measured and calibrated.
ダブルルーメン・カテーテル１０と２２と、採
血チユーブ１２と校正チユーブ２４、あるいはヘ
パリン加生食チユーブ１４と校正用ヘパリン加生
食チユーブ２６とは、同じ種類のものを使用する
のが好ましい。 The double lumen catheters 10 and 22, the blood collection tube 12 and the calibration tube 24, or the heparinized saline tube 14 and the heparinized saline tube 26 for calibration are preferably of the same type.
なお、５６，５８，６０，６２はそれぞれ内部
校正のための内部校正ポンプ、内部校正用チユー
ブ、内部校正液溶器、内部校正液である。内部校
正は第１図、第２図に共通であり、測定センサ５
０の汚れなどによる性能低下を校正するものであ
る。切替器４７を切替え、内部校正ポンプ５６に
より内部校正液６２を測定センンサ５０へ送るこ
とによつて行なうことができる。 Note that 56, 58, 60, and 62 are an internal calibration pump, an internal calibration tube, an internal calibration solution container, and an internal calibration solution for internal calibration, respectively. Internal calibration is common to Figures 1 and 2, and the measurement sensor 5
This is to calibrate performance deterioration due to zero contamination. This can be done by switching the switch 47 and sending the internal calibration liquid 62 to the measurement sensor 50 using the internal calibration pump 56.
本実施例に用いる測定センサ５０は、血糖値を
測定するための酵素膜と金属電極とからなる酵素
電極であり、血糖値に対応する出力電流値を血糖
値に換算することによつて測定される。 The measurement sensor 50 used in this embodiment is an enzyme electrode consisting of an enzyme membrane and a metal electrode for measuring blood sugar level, and is measured by converting an output current value corresponding to the blood sugar level into a blood sugar level. Ru.
以下、犬の末梢静脈からの連続採血サンプルを
連続測定した血糖測定の例を示す。 An example of blood sugar measurement in which blood samples were continuously collected from a peripheral vein of a dog is shown below.
（実施例 １）
第３図は、第２図による従来方法で、ダブルル
ーメン・カテーテル１０から校正用サンプル２３
として標準液を吸引して校正した後、該ダブルル
ーメン・カテーテル１０を穿刺して血糖を連続測
定した例である。(Example 1) FIG. 3 shows the calibration sample 23 from the double lumen catheter 10 using the conventional method shown in FIG.
This is an example in which blood sugar was continuously measured by puncturing the double lumen catheter 10 after aspirating and calibrating a standard solution.
別に採取した採血サンプルの他計器による血液
分析値（黒丸、以下と同じ）と、連続血糖測定値
（実線、以下同じ）との間に約５％前後のずれが
認められ、18時間経過後はさらに大きくなり約10
％になつている。測定センサ５０の出力は、前に
述べた方法で定期的に校正されているため、この
ずれは穿刺による物理的変化、ならびにしごきに
よる採血チユーブ１２、ヘパリン加生食チユーブ
４おおよび希釈チユーブ３６の経時変化によるも
のである。 A discrepancy of approximately 5% was observed between the blood analysis value of a separately collected blood sample (black circle, same as below) and the continuous blood glucose measurement value (solid line, same below), and after 18 hours, Even bigger, about 10
%. Since the output of the measurement sensor 50 is regularly calibrated using the method described above, this deviation is due to physical changes due to puncturing, as well as aging of the blood collection tube 12, heparinized food tube 4, and dilution tube 36 due to straining. This is due to change.
（実施例 ２）
第４図は、本発明にかかわる第１図において、
第２図と同じ方法で血糖を連続測定し、開始の直
後に、切替器２８，３０により採血チユーブ１２
とヘパリン加生食チユーブ１４と、校正チユーブ
２４と校正用ヘパリン加生食チユーブ２６とに切
り替え、別に採血した採血サンプルを校正用サン
プル２３として吸引し、穿刺による誤差の校正を
行なつた後、同じ方法で２時間ごとに校正を行な
い、採血部位のの経時変化を校正したものであ
る。この結果、他計器による血糖分析値と連続血
糖測定値との間のずれはかなり改善された。(Example 2) FIG. 4 shows that in FIG. 1 related to the present invention,
Continuously measure blood sugar using the same method as shown in FIG.
Then, switch to the heparinized food tube 14, the calibration tube 24, and the calibration heparinized food tube 26, aspirate a separately drawn blood sample as the calibration sample 23, and calibrate the error caused by puncturing, then repeat the same method. Calibration was performed every 2 hours, and changes over time at the blood sampling site were calibrated. As a result, the discrepancy between blood sugar analysis values measured by other instruments and continuous blood sugar measurement values has been significantly reduced.
しかしながら、12時間以降は約５％前後のずれ
が認められる。このずれれは採血チユーブ、ヘパ
リン加生食チユーブおよび希釈チユーブの経時変
化にによるものである。 However, after 12 hours, a deviation of around 5% is observed. This deviation is due to changes over time in the blood collection tube, heparinized food tube, and dilution tube.
（実施例 ３）
第５図は、校正用サンプル２３として、実施例
２における別の採血したサンプルの代りに標準液
を使用して校正した例である。この結果、他社計
器による血糖分析値と連続血糖測定値とのずれは
かなり改善されているが、全体的に約５％前後の
ずれが認められる。このずれは、採血チユーブ１
２、ヘパリン加生食チユーブ１４および希釈チユ
ーブ３６のしごきによる経時変化は校正されたの
で、穿刺による誤差および採血部位の経時変化で
ある。(Example 3) FIG. 5 shows an example in which a standard solution was used as the calibration sample 23 instead of another blood sample in Example 2 for calibration. As a result, although the discrepancy between blood glucose analysis values and continuous blood glucose measurements measured by other companies' instruments has been considerably improved, overall discrepancies of around 5% are observed. This deviation is due to blood collection tube 1
2. Changes over time due to squeezing of the heparinized food tube 14 and dilution tube 36 have been calibrated, so these are errors due to puncturing and changes over time at the blood sampling site.
（実施例 ４）
第６図は、実施例２と実施例３とを組み合わせ
て校正した例である。すなわち、まず、校正用サ
ンプル２３として標準液で校正した後、校正用サ
ンプル２３として別に採血し採血サンプルで校正
する。(Example 4) FIG. 6 is an example of calibration by combining Example 2 and Example 3. That is, first, calibration is performed using a standard solution as the calibration sample 23, and then blood is separately collected as the calibration sample 23, and calibration is performed using the blood sample.
この方法により、他計器による血液分析値と連
続血糖測定値とのずれは大幅に改善され、全体を
通じて３％以内に収めることができた。 With this method, the discrepancy between blood analysis values measured by other instruments and continuous blood glucose measurements was significantly improved, and was able to be kept within 3% throughout.
本実施例１〜４では、いずれも２時間間隔の校
正を行なつたが、必ずしも２時間にこだわること
なく、適宜行なうことができる。 In Examples 1 to 4, calibration was performed at intervals of 2 hours, but the calibration is not necessarily limited to 2 hours, and can be performed as appropriate.
本発明の最終目的は、実施例４によつて達成さ
れている。 The final objective of the present invention is achieved by Example 4.
これまで述べてきたとおり、連続採血サンプル
の特定物質濃度を測定するに当たり、採血チユー
ブとヘパリン加生食チユーブに切替器を介して、
校正用チユーブと校正用ヘパリン加生食チユーブ
とを接続せしめ、切替器を切り替えることによつ
て流路を変更し、任意の時間に校正サンプルとし
て標準液あるいは採血サンプルによる外部校正を
可能ならしめることによつて、採血針の穿刺によ
る誤差の校正ならびに採血部位、採血チユーブ、
ヘパリン加生食チユーブおび希釈チユーブの経時
変化の校正を可能とした。
As mentioned above, when measuring the concentration of a specific substance in continuously collected blood samples, a switch is used between the blood collection tube and the heparinized food tube.
By connecting the calibration tube and the heparinized food tube for calibration and changing the flow path by switching the switch, it is possible to perform external calibration using a standard solution or a blood sample as a calibration sample at any time. Therefore, it is necessary to calibrate errors caused by blood sampling needle puncture, as well as the blood sampling site, blood sampling tube,
It was possible to calibrate changes over time in heparinized diet tubes and diluted tubes.
この結果、従来の未対策であつたこれらの問題
を解決し、測定値の信頼性を飛躍的に改善するこ
とが可能となつた。 As a result, it has become possible to solve these problems that have not been addressed in the past, and to dramatically improve the reliability of measured values.
測定値の精度は、いかなる場合においても高い
ことが必要であることはもちろんであるが、特に
人工膵臓のごとく測定された血糖値に基づいて、
インスリンあるいはブドウ糖を注入する治療シス
テムにおいては、いかに重要であるかは説明を要
しない。 It goes without saying that the accuracy of the measurement value must be high in any case, but especially when it is based on the blood sugar level measured by an artificial pancreas,
It is unnecessary to explain how important this is in therapeutic systems that inject insulin or glucose.
かかる観点から、本発明は極めて有効な発明で
ある。 From this point of view, the present invention is extremely effective.
本発明においては、主に連続採血サンプルの血
糖測定について説明したが、本発明の精神を逸脱
しない範囲内において、広く応用できることは言
うまでもない。 In the present invention, the description has mainly been given of blood glucose measurement of continuously collected blood samples, but it goes without saying that the present invention can be widely applied without departing from the spirit of the present invention.
第１図は、本発明にかかわるフロー図、第２図
は従来方法によるフロー図を示し、第３〜６図
は、犬の末梢静脈からの採血サンプルの連続血糖
測定値（実線）と、他計器による血糖分析値（黒
丸）とをプロツトしたものである。第３図は、従
来方式で外部校正を全く行なわない場合、第４図
は、別に採血した採血サンプルを校正用サンプル
に使用し、穿刺による誤差を校正し、さらに２時
間ごとに採血部位の経時変化を校正した場合、第
５図は、校正用サンプルとして標準液を使用し、
採血チユーブ、ヘパリン加生食チユーブおよび希
釈液チユーブの経時変化を校正した場合、第６図
は、校正用サンプルに別に採血した採血サンプル
と標準液とを使用し、逐次校正を行なつた場合で
ある。
１０………ダブルルーメン・カテーテル、１２
……採血チユーブ、１４……ヘパリン加生食チユ
ーブ、１６……ヘパリン加生食容器、１８……ヘ
パリン加生食水、２０……ドリツプチヤンバ、２
２……ダブルルーメン・カテーテル、２３……校
正用サンプル、２４……校正チユーブ、２６……
校正用ヘパリン加生食チユーブ、２８，３０……
切替器、３２……採血ポンプ、３４……希釈ポン
プ、３６……希釈チユーブ、３８……希釈液容
器、４０……希釈液、４２……気泡混入チユー
ブ、４４……混合器、４６……混合コイル、４７
……切替器、４８……気泡分離器、５０……測定
センサ、５２……廃液チユーブ、５４……廃液容
器、５６……内部校正ポンプ、５８……内部校正
用チユーブ、６０……内部校正液容器、６２……
内部校正液。
Fig. 1 shows a flowchart according to the present invention, Fig. 2 shows a flowchart according to a conventional method, and Figs. This is a plot of blood sugar analysis values (black circles) measured by a meter. Figure 3 shows a conventional method in which no external calibration is performed at all, and Figure 4 shows a case in which a separately collected blood sample is used as a calibration sample to calibrate errors caused by puncturing, and the blood sampling site is measured over time every 2 hours. When the change is calibrated, Figure 5 shows that using the standard solution as the calibration sample,
In the case of calibrating the changes over time in the blood collection tube, heparinized food tube, and diluent tube, Figure 6 shows the case in which a separately drawn blood sample and a standard solution were used as calibration samples, and calibration was performed sequentially. . 10...Double lumen catheter, 12
...Blood collection tube, 14...Heparinized food tube, 16...Heparinized food container, 18...Heparinized saline water, 20...Drip tube, 2
2... Double lumen catheter, 23... Calibration sample, 24... Calibration tube, 26...
Heparinized food tube for calibration, 28, 30...
Switching device, 32... Blood collection pump, 34... Dilution pump, 36... Dilution tube, 38... Diluent container, 40... Diluent, 42... Air bubble mixing tube, 44... Mixer, 46... Mixing coil, 47
...Switcher, 48...Bubble separator, 50...Measurement sensor, 52...Waste liquid tube, 54...Waste liquid container, 56...Internal calibration pump, 58...Internal calibration tube, 60...Internal calibration Liquid container, 62...
Internal calibration solution.
Claims (1)
採血サンプル中の特定物質濃度を測定する装置に
おいて、採血チユーブとヘパリン加生食チユーブ
の、ダブルル−メンカテーテルと採血ポンプの間
の部分に、それぞれ校正用チユーブと校正用ヘパ
リン加生食チユーブとを分岐連続するとともに、
採血チユーブと校正用チユーブとの、またヘパリ
ン加生食チユーブと校正用ヘパリン加生食チユー
ブとの間の流路切り替え手段をそれぞれ設け、さ
らに校正用チユーブと校正用ヘパリン加生食チユ
ーブの他端に他のダブルルーメンカテーテルを連
結させることにより、測定センサに導く液体を採
血サンプルから校正用サンプルに切り替えて測定
もしくは校正できるようにしたことを特徴とする
連続採血サンプルの特定物質濃度測定装置。1. In a device that measures the concentration of a specific substance in a continuously collected blood sample by guiding the continuously collected blood sample to a measurement sensor, a calibration tube is installed between the double lumen catheter and the blood collection pump in the blood collection tube and heparinized saline tube, respectively. and a heparinized food tube for calibration.
A flow path switching means is provided between the blood collection tube and the calibration tube, and between the heparinized food tube and the calibration heparinized food tube. A specific substance concentration measuring device for continuous blood samples, characterized in that by connecting a double lumen catheter, measurement or calibration can be performed by switching the liquid introduced to the measurement sensor from the blood sample to the calibration sample.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| JP61029394A JPS62186846A (en) | 1986-02-13 | 1986-02-13 | Method for measuring concentration of specific substance in continuous sampling blood specimen |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| JP61029394A JPS62186846A (en) | 1986-02-13 | 1986-02-13 | Method for measuring concentration of specific substance in continuous sampling blood specimen |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| JPS62186846A JPS62186846A (en) | 1987-08-15 |
| JPH0334723B2 true JPH0334723B2 (en) | 1991-05-23 |
Family
ID=12274923
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP61029394A Granted JPS62186846A (en) | 1986-02-13 | 1986-02-13 | Method for measuring concentration of specific substance in continuous sampling blood specimen |
Country Status (1)
| Country | Link |
|---|---|
| JP (1) | JPS62186846A (en) |
Families Citing this family (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JP4808461B2 (en) * | 2004-10-05 | 2011-11-02 | 日機装株式会社 | Biological component measurement unit, biological component measurement unit package, medical support instrument kit, and medical support instrument kit package |
| CN101278197B (en) | 2005-10-05 | 2013-01-30 | 日机装株式会社 | Biological component measuring unit, biological component measuring unit bag, medical care assistance equipment kit, and medical care assistance equipment kit bag |
Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JPS52135795A (en) * | 1976-05-06 | 1977-11-14 | Miles Lab | Apparatus for correcting sensor |
| JPS57178151A (en) * | 1981-04-24 | 1982-11-02 | Kyoto Daiichi Kagaku:Kk | Automatic and continuous measuring apparatus of blood component |
-
1986
- 1986-02-13 JP JP61029394A patent/JPS62186846A/en active Granted
Patent Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JPS52135795A (en) * | 1976-05-06 | 1977-11-14 | Miles Lab | Apparatus for correcting sensor |
| JPS57178151A (en) * | 1981-04-24 | 1982-11-02 | Kyoto Daiichi Kagaku:Kk | Automatic and continuous measuring apparatus of blood component |
Also Published As
| Publication number | Publication date |
|---|---|
| JPS62186846A (en) | 1987-08-15 |
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