US20050202397A1 - Method and device for determining the hematocrit and/or blood volume - Google Patents

Method and device for determining the hematocrit and/or blood volume Download PDF

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Publication number
US20050202397A1
US20050202397A1 US10/507,033 US50703305A US2005202397A1 US 20050202397 A1 US20050202397 A1 US 20050202397A1 US 50703305 A US50703305 A US 50703305A US 2005202397 A1 US2005202397 A1 US 2005202397A1
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Prior art keywords
blood
cannula
pressure
haematocrit
arterial
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US10/507,033
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English (en)
Inventor
Wei Zhang
Helge Brauer
Reiner Spickermann
Carsten Muller
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Priority to US11/717,812 priority Critical patent/US7780620B2/en
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/36—Other treatment of blood in a by-pass of the natural circulatory system, e.g. temperature adaptation, irradiation ; Extra-corporeal blood circuits
    • A61M1/3621—Extra-corporeal blood circuits
    • A61M1/3639—Blood pressure control, pressure transducers specially adapted therefor
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/14—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis
    • A61M1/16—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis with membranes
    • A61M1/1601—Control or regulation
    • A61M1/1613—Profiling or modelling of patient or predicted treatment evolution or outcome
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/36—Other treatment of blood in a by-pass of the natural circulatory system, e.g. temperature adaptation, irradiation ; Extra-corporeal blood circuits
    • A61M1/3621—Extra-corporeal blood circuits
    • A61M1/3653—Interfaces between patient blood circulation and extra-corporal blood circuit
    • A61M1/3659—Cannulae pertaining to extracorporeal circulation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/14—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis
    • A61M1/16—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis with membranes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2230/00—Measuring parameters of the user
    • A61M2230/20—Blood composition characteristics
    • A61M2230/207—Blood composition characteristics hematocrit

Definitions

  • the invention relates to a method for determining the haematocrit and/or blood volume during an extracorporeal blood treatment with an extracorporeal blood circuit and an apparatus for extracorporeal blood treatment with an extracorporeal blood circuit and a device for determining the haematocrit and/or blood volume.
  • blood pressure monitors which continuously monitor a change in blood pressure and regulate the ultrafiltration depending on the change in blood pressure.
  • blood volume monitors are known which measure the relative blood volume during the dialysis treatment and perform a regulation of the ultrafiltration depending on the relative blood volume.
  • DE-C-197 46 377 describes a device for the measurement of blood pressure, which is based on the detection of the propagation rate of the pulse waves being propagated via the arterial vessel system of the patient, said pulse waves being generated by the patient's heart contractions.
  • the device permits a continuous, non-invasive measurement of blood pressure, but there is the drawback that the pulse-wave running time is dependent on the haematocrit (HKT).
  • DE-A-40 24 434 describes a device for the regulation of ultrafiltration, in which the pressure in the extracorporeal circuit is measured in order to determine the relative blood volume.
  • the measured pressure values are stored in chronological sequence and the change in the blood volume is deduced from the change in the pressure value compared with the value at the start of the treatment.
  • the venous return-flow or arterial suction-pressure sensor can be used as a pressure sensor. It is pointed out in the publication that the drop in pressure on the arterial cannula is a function of the blood flow and the viscosity of the blood as well as a function both of the diameter and length of the cannula. It is further assumed that the relationship between the blood volume and the change in pressure is linear to a good approximation.
  • the problem underlying the invention is to provide a method that permits the haematocrit and/or blood volume to be determined with a particularly high degree of accuracy, but with a relatively low technical outlay. Moreover, it is a problem of the invention to provide an apparatus for extracorporeal blood treatment with a device for determining the haematocrit and/or blood volume, which has a relatively simple construction, but a high degree of accuracy.
  • the known dialysis devices measure and monitor the arterial pressure P art (t) and the venous pressure P ven (t) in the extracorporeal blood circuit. Moreover, the rate BPR(t) of the blood pump is also measured during the blood treatment, i e. it is known as the control value.
  • the method according to the invention and the apparatus according to the invention make use of the pressure measurement that is already available, so that the outlay on equipment is relatively low.
  • the basic idea of monitoring the haematocrit and blood volume through the measurement of pressure is based on the following. If the relative blood volume diminishes during the blood treatment as a result of ultrafiltration, the haematocrit in the blood necessarily increases, since the dialysis membrane is not permeable for the blood cells, namely erythrozytes (7.5 ⁇ m), leucozytes (1.5-20 ⁇ m) and thromborytes (2.5 ⁇ m). Furthermore, the viscosity increases over-proportionately with increasing haematocrit.
  • each increase in the haematocrit caused by the reduction in blood volume signifies an increased load on the blood pump, which leads to the fall in the arterial pressure (negative) and the increase in the venous pressure (positive), insofar as the blood pump is operated at the same rate.
  • the respective relationship between haematocrit or blood volume and pressure is stored for different diameters of the cannula and different values of the blood flow in the case of the method and the apparatus according to the invention.
  • the respective data are thus already available before the dialysis treatment.
  • the respective relationship between haematocrit or blood volume and pressure is then selected and haematocrit and/or blood volume is determined taking account of the selected relationship.
  • the data can for example be stored in the form of groups of curves, which can be described in particular by discrete measurement values.
  • the increased accuracy results from the fact that account is taken not only of the blood flow during the treatment, but also of the cannula used.
  • both absolute values as well as relative values are to be understood, which indicate a relative change in the blood volume in respect of a predetermined initial value, for example the start of the blood treatment.
  • the arterial pressure which is measured in the arterial blood line upstream of the blood pump, correlates with the relative blood volume much better than the venous pressure in the venous blood line. This can be traced back to the fact that the venous pressure is very much more susceptible to interference than the arterial pressure.
  • the venous pressure sensor detects pressure fluctuations which are caused not only by the ultrafiltration, but also by switching balancing chambers.
  • the air volume, or more precisely the reveal in the venous drip chamber also has a strong influence on the characteristic of the venous pressure signal.
  • the arterial pressure is free from such pressure fluctuations. It is true that the arterial pressure signal is influenced by the blood pumping rate, but here it concerns an unequivocal source of interference whose influence on the arterial pressure can be compensated for.
  • the cannula diameter can be determined unequivocally by evaluating the pressure changes in the extracorporeal blood circuit.
  • the change in pressure resulting from a change in the blood flow is determined and the cannula diameter is deduce from the change in pressure.
  • the pressures are preferably measured at least two different values of the blood flow in each case, and the difference between the pressures is calculated.
  • the difference in the pressures is compared with predetermined stored value ranges representative of the individual cannula diameters. The individual value ranges can be assigned unequivocally to the different cannula diameters. The assignment between cannula diameter and value range can in principle be verified again by several measurements.
  • the relationship between haematocrit or blood volume and pressure for different diameters of the cannula and different values of the blood flow can be described to a sufficient approximation by a non-linear function, for example a second-order polynomial. Since the blood flow correlates with the rate of the blood pump, the pumping rate, which is preset by the control of the blood treatment device, is preferably used to determine the blood flow.
  • the blood volume can be calculated.
  • the blood volume is calculated at a specified time in the blood treatment from the product of the haematocrit at a preceding time and the blood volume at a preceding time divided by the haematocrit at the specified time.
  • the device for determining the haematocrit and/or blood volume of the apparatus for extracorporeal blood treatment has a memory and evaluation unit, in which the respective relationships between haematocrit and blood volume for the different cannula diameters and blood flows are stored.
  • a memory and evaluation unit can be part of a computer control, which is already present in the known blood treatment apparatuses.
  • the measurement of the pressure preferably takes place with a pressure sensor which is also already present.
  • the determination of the cannula diameter on the basis of a pressure measurement is of inherent inventive significance.
  • the knowledge of the influence of the cannula can be used in an advantageous way with the method for blood pressure measurement known from DE-C-197 46 377, in that the influence of the blood density on the pulse-wave running time is compensated for or corrected so that the blood pressure measurement takes place with a higher degree of accuracy.
  • FIG. 1 the haematocrit (HKT(%)) as a function of the arterial pressure (P art (mmHg)) for various cannulas of differing diameter and differing length,
  • FIG. 2 the haematocrit (HKT(%)) as a function of the arterial pressure (P art (mmHg)) for various cannulas,
  • FIG. 3 the haematocrit (HKT(%)) as a function of the arterial pressure (P art (mmHg)) for various values of the blood flow with a first cannula
  • FIG. 4 the haematocrit (HKT(%)) as a function of the arterial pressure (P art (mmHg)) for various values of the blood flow with a second cannula,
  • FIG. 5 the haematocrit (HKT(%)) as a function of the arterial pressure (P art (mmHg)) for various values of the blood flow with a third cannula
  • FIG. 6 an example of embodiment of an extracorporeal blood treatment apparatus with a device for determining the haematocrit and/or blood volume in a simplified diagrammatic representation.
  • FIG. 1 shows the relationship between the haematocrit (HKT(%)) of the blood and the pressure in the arterial blood lime of the extracorporeal circuit with a constant blood pumping rate BPR of 250 ml/min. for seven different dialysis cannulas, which differ from one another in diameter and length.
  • the cannula with the designation V-711 has a diameter of 1.5 mm and a length of 15 mm.
  • the other cannulas are correspondingly designated in FIG. 1 . It can be seen in FIG. 1 that the relationship between haematocrit and arterial pressure is not linear. It can however be described to a good approximation by a second-order polynomial.
  • the relationship between haematocrit and pressure depends markedly on the diameter of the cannulas.
  • the influence of the length of the cannulas, on the other hand, is relatively small. This can therefore be neglected to a good approximation.
  • the relationship is grouped unequivocally according to the diameter of the cannulas, i.e. 1.5, 1.6 and 1.8 mm. Due to the marked dependence of the relationship on the diameter of cannulas, the measurement of the pressure for the determination of the haematocrit or blood volume without a knowledge of the cannula diameter leads to inaccurate results.
  • FIG. 2 shows the relationship of haematocrit and arterial pressure of a second measurement series with a blood flow rate BPR of 250 ml/min.
  • BPR blood flow rate
  • FIG. 3 shows the relationship between haematocrit (HKT(%)) and arterial pressure (P art (mmHg)) in the case of a needle with a diameter of 1.8 mm and a length of 20 min for a large number of blood flows BPR between 100 ml/min. and 550 mm/min.
  • the relationship is not linear. It can however again be described to a good approximation by a second-order polynomial.
  • the curves for different blood flows exhibit a similar gradient. Since the dependence of the blood flow, i.e.
  • the blood pumping rate is essentially expressed by the fact that the curves are displaced parallel to the x-axis and that the displacement is dependent on the diameter of the needle, the needle diameter can be determined unequivocally.
  • the diameter of the cannula can be detected without knowledge of the haematocrit. The detection takes place via measurement of the pressure difference with two different blood flows, i.e. blood pumping rates, whereby typical values lie between 130 ml/min. and 310 ml/min.
  • FIGS. 4 and 5 show the groups of curves of a needle with a diameter of 1.6 mm and a length of 20 mm and respectively a needle with a diameter of 1.5 mm and length of 15 mm.
  • the following table shows the pressure difference ⁇ P art (mmHg) for the three cannulas of differing diameter (1.8, 1.6 and 1.5 min) with a haematocrit HKT of 30 and 40%.
  • the measurement magnitudes can be grouped into the value ranges 70-90 mmHg for a cannula diameter of 1.8 mm, 100 to 120 mmHg for a cannula diameter of 1.6 min and 130 to 150 mmHg for a cannula diameter of 1.5 mm.
  • FIG. 6 shows the essential components of an extracorporeal blood treatment apparatus together with a device for determining the haematocrit and/or blood volume in a simplified diagrammatic representation.
  • the dialysis apparatus has a dialyser 1 , which is divided by a semipermeable membrane 2 into a blood chamber 3 and a dialysis-fluid chamber 4 .
  • An arterial blood line 5 leads to the inlet of blood chamber 3 , a peristaltic blood pump 6 being connected into said arterial blood line.
  • a venous blood line 7 leads off from blood chamber 3 , a drip chamber 8 being connected into said venous blood line.
  • cannulas 5 a, 7 a which are jabbed into the patient.
  • the arterial and venous blood line are a component of a flexible-tube line system designed to be disposable.
  • Fresh dialysis fluid is prepared in a dialysis-fluid source 9 .
  • a dialysis-fluid supply line 10 leads from dialysis-fluid source 9 to an inlet of dialysis-fluid chamber 4 of the dialyser, whilst a dialysis-fluid discharge line 11 leads from the outlet of the dialysis-fluid chamber to a drain 12 .
  • the dialysis apparatus also has further components, e.g. a balancing device and an ultrafiltration device etc., which however are not represented for the sake of better clarity.
  • the central control unit which is a component of the dialysis apparatus, is not represented.
  • the arterial pressure in arterial blood line 5 is monitored upstream of blood pump 6 and the venous pressure in the venous blood line is monitored downstream of drip chamber 8 in the dialysis apparatus.
  • an arterial pressure sensor 13 is provided in arterial blood line 5 and a venous pressure sensor 14 is provided in venous blood line 7 .
  • the device for determining the haematocrit and/or blood volume has arterial pressure sensor 13 already available in the dialysis apparatus as well as a memory and evaluation unit 15 .
  • Memory and evaluation unit 15 receives the pressure signal of arterial pressure sensor 13 via a data line 16 .
  • the memory and evaluation unit can receive the pressure signal of a venous pressure sensor 14 via a data line 17 .
  • Data line 17 is shown by a dashed line in FIG.
  • memory and evaluation unit 15 is connected to blood pump 6 via a data line 18 .
  • a blood pump signal proportional to the blood pumping rate is transmitted via data line 18 .
  • the curve groups represented in FIGS. 3-5 which describe the relationship between haematocrit and arterial pressure, are stored in the memory and evaluation unit.
  • the memory and evaluation unit operates as follows.
  • the cannula diameter in which the blood pumping rate is varied, is first determined in an initial measurement during the dialysis treatment, whereby the arterial pressures P art1 and P art2 are measured at two predetermined blood pumping rates BPR of, for example, 310 and 130 mm ( FIG. 3 ).
  • the value ranges from 70 to 90, 100 to 120 and 130 to 150 mmHg characteristic of the cannula diameter, which are described above.
  • the memory and evaluation unit performs an assignment between the measured pressure difference ⁇ P art and the stored value ranges. Since the measured pressure difference ⁇ P art lies here in the value range between 70-90 mmHg, the memory and evaluation unit assumes that the cannula has a diameter of 1.8 mm ( FIG. 3 ).
  • the memory and evaluation unit carries out a selection between the different curve groups ( FIGS. 3-5 ), which respectively describe the relationship of haematocrit and arterial pressure for the respective needle diameter.
  • the memory and evaluation unit selects here the group of curves according to FIG. 3 , which are representative of the present needle diameter of 1.8 mm.
  • the memory and evaluation unit determines from the appropriate curve group, with a high degree of accuracy, the appropriate haematocrit in dependence on the blood pumping rate BPR(t) taking account of the diameter of the employed cannula, without the diameter of the used cannula needing to be inputted manually. If, for example, an arterial pressure of 100 mmHg is measured with the arterial pressure sensor, a haematocrit of approx. 33% results with a blood pumping rate of 310 mm ( FIG. 3 ). With decreasing blood pumping rate, the haematocrit increases according to the curve group.
  • the determination of the blood volume takes place after the haematocrit has been ascertained.
  • the memory and evaluation unit can determine RBV(t) relative to this time.
  • the above equation can also be used for two arbitrary times t 0 and t 0 if to does not coincide with the start of the treatment and RBV (t o ) is thus not necessarily 1. If RBV (t o ) is not known, the memory and evaluation unit can however determine relative changes in RBV according to the above equation compared with a value of RBV (t o ) of 1.
US10/507,033 2002-03-07 2003-01-09 Method and device for determining the hematocrit and/or blood volume Abandoned US20050202397A1 (en)

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US11/717,812 US7780620B2 (en) 2002-03-07 2007-03-13 System and method for determining the hematocrit and/or blood volume

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
DE10210009A DE10210009B3 (de) 2002-03-07 2002-03-07 Verfahren zur Bestimmung des Hämatokrit und/oder Blutvolumens und Vorrichtung zur extrakorporalen Blutbehandlung mit einer Einrichtung zur Bestimmung des Hämatokrit und/oder Blutvolumens
DE10210009.8 2002-03-07
PCT/EP2003/000126 WO2003074109A1 (fr) 2002-03-07 2003-01-09 Procede et dispositif de determination du taux d'hematocrite et/ou du volume sanguin

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US11/717,812 Expired - Fee Related US7780620B2 (en) 2002-03-07 2007-03-13 System and method for determining the hematocrit and/or blood volume

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US (2) US20050202397A1 (fr)
EP (1) EP1480695B1 (fr)
JP (1) JP4304080B2 (fr)
CN (1) CN100441244C (fr)
AT (1) ATE387921T1 (fr)
AU (1) AU2003208321A1 (fr)
DE (2) DE10210009B3 (fr)
ES (1) ES2298499T3 (fr)
WO (1) WO2003074109A1 (fr)

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US20070061089A1 (en) * 2005-09-13 2007-03-15 Honeywell International Inc. Multiple wireless sensors for dialysis application
US20100096974A1 (en) * 2008-10-22 2010-04-22 General Electric Company Blue-green and green phosphors for lighting applications
US20130303964A1 (en) * 2012-05-10 2013-11-14 Fresenius Medical Care Deutschland Gmbh Apparatus for extra-corporeal blood treatment and method of determining a blood flow rate for an extra-corporeal blood treatment apparatus
US20140263065A1 (en) * 2013-03-13 2014-09-18 Keith Samolyk Method Of Controlling Blood Reservoir Volume And Flow In An Extracorporeal Blood Circulation System

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EP3178387A1 (fr) * 2009-06-26 2017-06-14 Gambro Lundia AB Dispositifs, produit-programme informatique et procédé d'extraction de données
JP5548001B2 (ja) * 2010-03-25 2014-07-16 日機装株式会社 血液浄化装置
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US20070061089A1 (en) * 2005-09-13 2007-03-15 Honeywell International Inc. Multiple wireless sensors for dialysis application
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JP4304080B2 (ja) 2009-07-29
CN100441244C (zh) 2008-12-10
ATE387921T1 (de) 2008-03-15
US7780620B2 (en) 2010-08-24
AU2003208321A1 (en) 2003-09-16
EP1480695A1 (fr) 2004-12-01
DE50309315D1 (de) 2008-04-17
ES2298499T3 (es) 2008-05-16
JP2005518876A (ja) 2005-06-30
US20080015486A1 (en) 2008-01-17
CN1638825A (zh) 2005-07-13
EP1480695B1 (fr) 2008-03-05
WO2003074109A1 (fr) 2003-09-12
DE10210009B3 (de) 2004-01-08

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