Process and apparatus for monitoring the progress of hemodialysis

• US 5,416,027 A
• Filed: 01/07/1993
• Issued: 05/16/1995
• Est. Priority Date: 01/07/1992
• Status: Expired due to Fees

• Current Assignee: Laboratorie Eugedia
• Original Assignee: Laboratoire Eugedia
• Inventors: Baudin, Serge, Jussiaux, Philippe
• Primary Examiner(s): BHAT, NINA NMN
• Application Number:
  US08/001,721
• Time in Patent Office: 859 Days
• Field of Search: 436/55, 436/70, 73/61.41, 210/646, 324/450
• US Class Current: 436/70
• CPC Class Codes: A61M 1/16 with membranes
• 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

Abstract

A process and an apparatus for monitoring the progress of haemodialysis by extra-corporeal measurement of the haematocrit are presented. The process comprises the steps of:

calculating at a given time the variation of a function of the haematocrit over a short period, on the one hand, and over a medium period preceding this time, on the other,

comparing the values of these variations,

the result of this comparison is a first indicator of the progress of the haemodialysis.

Claims

1. A process for monitoring the progress of hemodialysis by extra-corporal measurement of hematocrit, comprising the steps of:

a) continuously measuring values representative of the hematocrit,

b) continuously determining variations of these values over a short time period, over a medium time period and over a long time period, and normalizing the values with respect to a unique time base, obtaining thus normalized parameters PCD, PMD, and PLD, representative, respectively, of the variations of the hematocrit value measured over a short time period, over a medium time period, and over a long time period,

c) calculating a slope indicator value from the parameters PCD, PMD, and PLD in such a manner that the slope indicator increases inversely proportionally to an increase of the hematocrit,

d) determining an alarm indicator value by combining the slope indicator value with a threshold indicator value which depends on the specific hematocrit, and

(e) initiating action to prevent cardiovascular collapse in response to reaching the alarm indicator value.

2. A process according to claim 1, wherein the slope indicator value increases when variation of the value representative of the hematocrit over a short time period is less than the corresponding variation over a medium time period, and the slope indicator value decreases when the variation of the value representative of the hematocrit over the short time period is higher than the corresponding variation during the medium time period.

3. A process according to claim 1, wherein the slope indicator value increases when the variation of the value representative of the hematocrit over a medium time period is less than the corresponding variation over a long time period, and the slope indicator value decreases when the variation of the value representative of the hematocrit over the medium time period is higher than the corresponding variation over the long time period.

4. A process according to claim 1, wherein the long time period is defined as the total time elapsed since the beginning of the hemodialysis, the medium time period is in the order of 15 minutes and the short time period is in the order of 5 minutes.

5. A process according to claim 4, wherein the slope indicator value is obtained by combining parameters representative of the short time period variation, the medium time period variation, and the long time variation of the hematocrit value in such a way that the long time parameter has double weight with respect to the short time period parameter and one and a half times weight with respect to the medium period parameter.

6. A process according to claim 5, wherein the slope indicator value is obtained by combining the short time period, medium time period, and long time period parameters in such a way that the variation of the short time period parameter with respect to that of the medium time period parameter has approximately double weight compared to the corresponding variation of the medium time parameter with respect to that of the long time period parameter.

7. A process according to claim 1, wherein the threshold indicator value is proportional to the square of the variation of hematocrit since the beginning of the hemodialysis.

8. A process according to claim 7, wherein the alarm indicator value is the sum of the slope indicator value and the threshold indicator value.

9. A process according to claim 1, wherein the hematocrit value is obtained by a measurement of blood impedance.

10. A process according to claim 9, wherein the impedance measurement results from averaged samples taken at a frequency of about 5 kHz.

11. A process according to claim 1 wherein said action comprises slowing down ultrafiltration.

12. A process according to claim 1 wherein said action comprises injection of solutes which induce an effect of plasma expansion.

13. Apparatus for monitoring the progress of haemodialysis by extra-corporeal measurement of the blood impedance comprising a measurement cell designed to be placed in a hemodialysis circuit, a constant-current generator, an impedance meter, said measurement cell comprising a semi-rigid tube provided with two openings closed by caps, two electrodes passing through said caps and each connected to the current source, and also connected to the impedance meter, wherein it comprises a calculator receiving the signal generated by the impedance meter and actuating an indicator of the progress of haemodialysis, in accordance with the process as claimed in claim 1.

14. Apparatus as claimed in claim 13, wherein the current source is supplied from the main power supply by a protection circuit.

15. Apparatus as claimed in claim 13, wherein the measurement cell is placed at the inlet of the hemodialysis device.

16. Apparatus as claimed in claim 13, wherein the current generator supplies a current with a frequency of approximately 5 kHz.

17. Apparatus for monitoring the progress of haemodialysis by extra-corporeal measurement of the blood impedance comprising a measurement cell designed to be placed in a hemodialysis circuit, a constant-current generator, an impedance meter, said measurement cell comprising a semi-rigid tube provided with two openings closed by caps, two electrodes passing through said caps and each connected to the current source, and also connected to the impedance meter, wherein it comprises a calculator receiving the signal generated by the impedance meter and actuating an indicator of the progress of hemodialysis, in accordance with the process as claimed in claim 1, wherein the current source is supplied from the main power supply by a protection circuit, wherein the measurement cell is placed at the inlet of the hemodialysis device, wherein the current generator supplies a current with a frequency of approximately 5 kHz.

18. Apparatus as claimed in claim 13, which comprises means for:

a) continuously measuring values representative of the hematocrit,

b) continuously determining variations of these values over a short time period, over a medium time period and over a long time period, and normalizing the values with respect to a unique time base, obtaining thus normalized parameters PCD, PMD, and PLD, representative, respectively, of the variations of the hematocrit value measured over a short time period, over a medium time period, and over a long time period,

c) calculating a slope indicator value from the parameters PCD, PMD, and PLD in such a manner that the slope indicator increases inversely proportionally to an increase of the hematocrit, and

d) determining an alarm indicator value by combining the slope indicator value with a threshold indicator value which depends on the specific hematocrit.