Process for the determination of the hematocrit level of whole blood and apparatus for carrying out the process

• US 4,835,477 A
• Filed: 08/14/1987
• Issued: 05/30/1989
• Est. Priority Date: 08/16/1986
• Status: Expired due to Term

• Current Assignee: Baylor College of Medicine (Baylor College), Fresenius AG (Fresenius SE & Co. KGaA)
• Original Assignee: Fresenius AG (Fresenius SE & Co. KGaA)
• Inventors: Metzner, Klaus, Polaschegg, Hans-Dietrich, Westphal, Detlef
• Primary Examiner(s): Strecker, Gerard R.
• Application Number:
  US07/086,495
• Time in Patent Office: 655 Days
• Field of Search: 324/425, 324/439, 324/441, 324/71.1, 324/71.4, 128/635, 204/400, 204/403, 204/406, 204/407, 436/70, 436/150, 364/413.07, 364/413.08, 364/413.09
• US Class Current: 324/439
• CPC Class Codes: A61M 1/3609 Physical characteristics of the blood, e.g. haematocrit, urea
• CPC Class Codes: A61M 1/3669 Electrical impedance measurement of body fluids; transducers specially adapted therefor
• CPC Class Codes: G01N 33/492 Determining multiple analytes

Abstract

There is described a method and apparatus for the determination of hematocrit levels in which both the conductivity of whole blood and the conductivity of blood plasma are determined together. While a conductivity cell (18) is being used for the determination of the conductivity of whole blood, the conductivity of plasma is calculated in a computer (30) with the aid of ion selective electrodes (14, 16) from the sodium or potassium concentrations.

Claims

1. A process for the determination of the hematocrit level of whole blood including the steps of:

measuring the conductivity of the whole blood

measuring the concentration of sodium ions or chloride ions in the whole blood

determining the conductivity of blood plasma from the concentration of sodium ions or chloride ions in the whole blood, and

determining the hematocrit level from the conductivity of the whole blood and the conductivity of blood plasma.

2. A process according to claim 1 in which the concentration of sodium ions in the whole blood is measured, the concentration of potassium ions in the whole blood is measured, and the conductivity of blood plasma is determined from the concentrations of sodium and potassium ions in the whole blood.

3. A process according to claim 2 in which the conductivity of blood plasma is calculated according to the linear equation

4. A process according to claim 3 in which the constant K amounts to about 72 to 88, the constant A amounts to about 0.058 to 0.082, the constant B amounts to about 1.2×

A and the constant D amounts to 0 to 2.

5. A process according to claim 4 in which the constant K is about 80, the constant A is about 0.07 and the constant D is about 1.

6. A process according to claim 2 in which use is made of a quadratic approximation corresponding to the equation

7. A process according to claim 6 to which P amounts to about 47 and Q amounts to about 52.

8. A process according to claim 1 in which the determination of ion concentrations is carried out with ion selective electrodes.

9. Apparatus for the determination of the hematocrit level of whole blood comprising:

a device for measuring the conductivity of the whole blood,

a device for determining the conductivity of blood plasma incorporating a sodium ion selective electrode for measuring the concentration of sodium ions in the whole blood or a chloride ion selective electrode for measuring the concentration of chloride ions in the whole blood and computing means (32 to

     40) for the determination of the conductivity of blood plasma in response to a signal from the sodium ion selective electrode or the chloride ion selective electrode, and

a determining unit (44) for receiving values from the device for measuring the conductivity of the whole blood and from the computing means (32 to

     40) and for determining the hematocrit level from the conductivity of the whole blood and the conductivity of blood plasma.

10. Apparatus according to claim 9 in which the device for measuring the conductivity of the whole blood comprises a conductivity cell (18) and a calculating unit (42) for determining the conductivity of the whole blood from a signal obtained from the conductivity cell (18).

11. Apparatus according to claim 10 comprising a computer (30) incorporating the computing means (32 to 40), the calculating unit (42) and the determining unit (44) and in which the computing means (32 to 40) includes a summer (40) and both the summer (40) and the calculating unit (42) are connected to the determining unit (44) to supply signals respectively representative of the conductivity of blood plasma and the conductivity of the whole blood.

12. Apparatus according to claim 9 in which the device for determining the conductivity of blood plasma incorporates sodium ion selective and potassium ion selective electrodes, both of which are operable to supply signals to the computing means (32 to 40).

13. Apparatus according to claim 12 in which the computing means (32 to 40) comprises computing units (32 and 34) respectively for the determination of the sodium ion and potassium ion concentrations from signals from the sodium ion selective electrode (14) and the potassium ion selective electrode (16), coordinating units (36 and 38) with which the concentration values determined respectively in the computing units (32 and 34) are respectively multiplied with constants (A and B), and a summer (40) with which the values determined respectively in the coordinating units (36 and 38) are added together with a further constant (D).

14. Apparatus according to claim 12 in which the device for measuring the conductivity of the whole blood comprises a conductivity cell (18) and a conduit (20) for conveying the whole blood and a housing (12) which surrounds the ion selective electrodes (14 and 16), the conductivity cell (18) and the conduit (20).