Method and device for the detection of disruptions of the blood flow in an extracorporeal blood circuit

• US 8,460,552 B2
• Filed: 09/11/2004
• Issued: 06/11/2013
• Est. Priority Date: 11/25/2003
• Status: Expired due to Fees

• Current Assignee: Fresenius Medical Care Deutschland GmbH (Fresenius SE & Co. KGaA)
• Original Assignee: Fresenius Medical Care Deutschland GmbH (Fresenius SE & Co. KGaA)
• Inventors: Kopperschmidt, Pascal, Gross, Malte
• Primary Examiner(s): Kim, Vickie
• Assistant Examiner(s): Gionta, Allison M
• Application Number:
  US10/580,869
• Publication Number:
  US 20070108128A1
• Time in Patent Office: 3,195 Days
• Field of Search: 210/645, 735/92
• US Class Current: 210/645
• CPC Class Codes: A61M 1/3434 with pre-dilution and post-dilution
• CPC Class Codes: A61M 1/3437 downstream of the filter, e.g. post-dilution with filtrate
• CPC Class Codes: A61M 1/3441 Substitution rate control as a function of the ultrafiltration rate
• CPC Class Codes: A61M 1/3609 Physical characteristics of the blood, e.g. haematocrit, urea
• CPC Class Codes: A61M 1/3639 Blood pressure control, pressure transducers specially adapted therefor
• CPC Class Codes: A61M 2230/207 hematocrit

Abstract

A method and device that identify impairments of the blood flow in an extra-corporeal blood circuit during extracorporeal treatment of the blood using an extracorporeal haemodialysis device, where the phase angle of at least one harmonic oscillation of an oscillating pressure signal that propagates in the extracorporeal blood circuit is determined. Impairments of the blood flow are detected in the extracorporeal blood circuit based on a characteristic modification of the phase angle of at least one harmonic oscillation of the pressure signal. A temporal modification of the phase angle may be compared with a predefined threshold value and an impairment is detected if the value of the modification of the phase angle is greater than the predefined threshold value. The method and device permit an early identification of a coagulation of the blood that flows through the haemodialysis unit, so that countermeasures can be initiated promptly.

Claims

1. A method for the detection of disruptions of blood flow in an extracorporeal blood circuit during an extracorporeal blood treatment with an extracorporeal blood treatment apparatus, the extracorporeal blood circuit comprising an arterial branch leading to a blood treatment unit and a venous branch leading away from the blood treatment unit, the method comprising:

measuring an oscillating pressure signal propagated in the extracorporeal blood circuit; and

analyzing the oscillating pressure signal, including

ascertaining the phase angle of at least one harmonic of the oscillating pressure signal and

detecting a disruption of the blood flow in the extracorporeal blood circuit on the basis of the change in the phase angle of the at least one harmonic.

2. The method of claim 1, further comprising:

determining a temporal change of the phase angle, wherein the temporal change of the phase angle is determined by ascertaining a change in the phase angle of the at least one harmonic in a preset time unit; and

comparing the temporal change of the phase angle of the harmonic with a preset limiting value, whereby a disruption is detected if the amount of the change in the phase angle is greater than the preset limiting value.

3. The method of claim 1, further comprising:

in the event of disruptions of the blood flow, intervening in the control of the extracorporeal blood treatment apparatus.

4. The method of claim 1, wherein the extracorporeal blood treatment apparatus is at least one of a haemodialysis and haemofiltration apparatus and the blood treatment unit is at least one of a dialyser and filter, further comprising:

withdrawing fluid at a preset ultrafiltration rate from the blood flowing through the extracorporeal blood circuit; and

feeding substitution fluid to the extracorporeal blood circuit to at least one of an upstream location and a downstream location of the at least one dialyser and filter.

5. The method of claim 4, wherein, in the event of a disruption, a specific quantity of substitution fluid is fed, in a preset time interval, to the blood upstream of at least one of the dialyser and filter as an intervention into the control of at least one of the haemodialysis and haemofiltration apparatus.

6. The method of claim 4, wherein, in the event of a disruption, the ultrafiltration rate is reduced in a preset time interval as an intervention into the control of at least one of the haemodialysis and haemofiltration apparatus.

7. The method of claim 1, wherein a Fourier analysis of the oscillating pressure signal is carried out in order to ascertain the phase angle of the at least one harmonic.

8. The method of claim 1, further comprising:

conveying blood in the arterial branch by a blood pump wherein the pressure pulses of the blood pump are measured as the oscillating pressure signal.

9. The method of claim 8, wherein the blood pump is an occluding pump.

10. The method of claim 1, wherein the oscillating pressure signal is measured with a pressure sensor arranged in the venous branch of the extracorporeal blood circuit.

11. A device for the detection of disruptions of blood flow in an extracorporeal blood circuit during an extracorporeal blood treatment with an extracorporeal blood treatment apparatus, the extracorporeal blood circuit comprising an arterial branch leading to a blood treatment unit and a venous branch leading away from the blood treatment unit, the device comprising:

a means for generating an oscillating pressure signal propagated in the extracorporeal blood circuit;

a means for measuring the oscillating pressure signal; and

a means for analyzing the oscillating pressure signal wherein the means for analyzing the oscillating pressure signal includes a means for determining the phase angle of at least one harmonic of the oscillating pressure signal and a means for detecting a change in the phase angle.

12. The device of claim 11, wherein the means for detecting a change in the phase angle is configured such that the change in the phase angle of at least one harmonic is ascertained in a preset time interval and the temporal change in the phase angle of the harmonic is compared with a preset limiting value, whereby a disruption is detected if the amount of the change in the phase angle is greater than the preset limiting value.

13. The device of claim 11, further comprising a means for intervening in the control of the extracorporeal blood treatment apparatus.

14. The device of claim 11, wherein the extracorporeal blood treatment apparatus is at least one of a haemodialysis and haemofiltration apparatus and the blood treatment unit is at least one of a dialyser and a filter, the extracorporeal blood treatment apparatus further comprising:

an ultrafiltration device that withdraws fluid at a preset ultrafiltration rate from the blood flowing through the extracorporeal blood circuit, and

a substitution device that supplies substitution fluid to the blood flowing through the extracorporeal blood circuit to at least one of an upstream location and a downstream location of at least one of the dialyser and filter.

15. The device of claim 14, further comprising a means for intervening in the control of at least one of the haemodialysis and haemofiltration apparatus, wherein the means for intervening controls the ultrafiltration device such that, when a disruption is detected, the ultrafiltration rate is reduced in a preset time interval.

16. The device of claim 14, further comprising a means for intervening in the control of at least one of the haemodialysis and haemofiltration apparatus, wherein the means for intervening controls the substitution device such that, when a disruption is detected, a specific quantity of substitution fluid is fed to the blood in a preset time interval upstream of at least one of the dialyser and filter.

17. The device of claim 11, wherein the means for determining the phase angle of at least one harmonic of the oscillating pressure signal includes a Fourier analysis device, which carries out a Fourier analysis of the oscillating pressure signal in order to ascertain the phase angle.

18. The device of claim 11, wherein the means for generating the oscillating pressure signal includes a blood pump arranged in the arterial branch of the extracorporeal blood circuit.

19. The device of claim 18, wherein the blood pump is an occluding pump.

20. The device of claim 11, wherein the means for measuring the oscillating pressure signal includes a pressure sensor arranged in the venous branch of the extracorporeal blood circuit.