Method and device for the detection of stenosis in extra-corporeal blood treatment

• US 6,623,443 B1
• Filed: 01/04/2000
• Issued: 09/23/2003
• Est. Priority Date: 01/14/1999
• Status: Expired due to Term

• Current Assignee: Fresenius Medical Care Deutschland GmbH (Fresenius Medical Care AG)
• Original Assignee: Hans-Dietrich Polaschegg
• Inventors: Polaschegg, Hans-Dietrich
• Primary Examiner(s): Sykes, Angela D.
• Assistant Examiner(s): Deak, Leslie R.
• Application Number:
  US09/477,198
• Time in Patent Office: 1,358 Days
• Field of Search: 210/645, 210/646, 210/739, 210/741, 210/745, 210/746, 210/767, 210/781, 210/782, 604/65-67, 604/505, 604/507, 604/6.16, 604/5.01, 604/5.04, 604/6.06, 604/6.09
• US Class Current: 604/5.04
• CPC Class Codes: A61M 1/16 with membranes
• CPC Class Codes: A61M 1/3639 Blood pressure control, pressure transducers specially adapted therefor
• CPC Class Codes: A61M 1/3656 Monitoring patency or flow at connection sites; Detecting disconnections
• CPC Class Codes: A61M 2205/3344 Measuring or controlling pressure at the body treatment site

Abstract

Stenosis in a blood access circuit (graft, fistula) or in an extracorporeal circuit are detected by monitoring pressure pulses in the extracorporeal circuit created either by the heart or by the peristaltic blood pump of the extracorporeal circuit. By monitoring pressure pulses created by the. peristaltic blood pump loss of occlusion of the blood pump can be detected. Measurement of the pressure pulses is done either with sensors already built into the blood treatment equipment or, according to the invention, with sensors mechanically coupled to the wall of the blood tubing. The deviation of a pressure pulse amplitude proportional signal from a predetermined value indicates stenosis or loss of occlusion, respectively.

Claims

1. An apparatus for detecting stenosis in a blood circuit which is part of an extracorporeal blood treatment system for a patient, the blood circuit comprising an extracorporeal portion and a patient portion, the extracorporeal portion being connected hydraulically to the patient portion with a blood access device, the apparatus comprising:

a. a pressure pulse source in the blood circuit creating pressure pulses;

b. at least one pressure sensor in the blood circuit; and

c. an evaluation unit receiving a measured pressure pulse amplitude proportional signal transmitted by the pressure sensor, said evaluation unit detecting stenosis using a deviation from a predetermined value of the pressure pulse amplitude proportional signal received from the pressure sensor.

2. The apparatus of claim 1, wherein the pressure pulse source is a pulsating blood pump in the extracorporeal portion of the blood circuit.

3. The apparatus of claim 2, wherein the pulsating blood pump is a peristaltic blood pump.

4. The apparatus of claim 1, wherein the pressure sensor is positioned between the blood access and the pressure pulse source.

5. The apparatus of claim 1, further comprising an extracorporeal blood treatment device hydraulically completing the extracorporeal portion of the blood circuit.

6. The apparatus of claim 5, wherein the pressure sensor is positioned between the pressure pulse source and the extracorporeal treatment device.

7. The apparatus of claim 5, wherein the pressure sensor is positioned between the extracorporeal treatment device and the blood access.

8. The apparatus of claim 5, wherein the extracorporeal blood treatment device is selected from the group consisting of hemodialyzer, hemofilter, hemodiafilter, plasmafilter, and hemoadsorber.

9. The apparatus of claim 5, wherein the pressure sensor is built into the extracorporeal blood treatment device.

10. The apparatus of claim 1, wherein the pressure pulse amplitude proportional signal is corrected by a pulse frequency dependent function.

11. The apparatus of claim 1, wherein the pressure pulse amplitude proportional signal is calculated from the peak-to-peak amplitude.

12. The apparatus of claim 1, wherein the pressure pulse amplitude proportional signal is calculated from a standard deviation computed over a predetermined interval.

13. The apparatus of claim 1, wherein the pressure pulse amplitude proportional signal is corrected by blood pump rate.

14. An apparatus for detecting stenosis in an arterial-venous shunt used as a blood access in an extracorporeal treatment for a patient, the device comprising:

a. at least one blood access cannula;

b. an extracorporeal blood circuit hydraulically connected to the blood access cannula;

c. an evaluation unit;

d. at least one pressure sensor in the extracorporeal blood circuit and sending a signal to the evaluation unit, wherein a stenosis in the arterial-venous shunt is detected from a deviation of a pressure pulse amplitude proportional signal measured by the pressure sensor from a predetermined value; and

e. a pressure pulse source in the blood circuit creating pressure pulses.

15. The apparatus of claim 14, wherein the pressure pulse amplitude proportional signal is normalized by a mean arterial pressure.

16. The apparatus of claim 14, wherein the pressure pulse amplitude proportional signals is normalized with a difference between a systolic blood pressure and a diastolic blood pressure.

17. The apparatus of claim 14, further comprising an extracorporeal treatment device.

18. The apparatus of claim 17 in which one of the at least one pressure sensor is built into the extracorporeal treatment device.

19. The apparatus of claim 17, wherein the extracorporeal treatment device is selected from the group consisting of hemodialyzer, hemofilter, hemodiafilter, plasmafilter, and hemoadsorber.

20. An apparatus for detecting a loss of occlusion in a peristaltic pump, comprising:

a. a pressure pulse source in a blood circuit;

b. an evaluation unit; and

c. at least one pressure sensor in the blood circuit and transmitting a signal to the evaluation unit, wherein the loss occlusion is detected from an increase of a pressure pulse amplitude signal from a predetermined value.

21. The apparatus of claim 20, wherein the pressure pulse amplitude signal is normalized by a mean pressure measured with the same pressure sensor.

22. The apparatus of claim 20, further comprising an extracorporeal treatment device.

23. The apparatus of claim 22 in which one of the at least one pressure sensor is built into the extracorporeal treatment device.

24. The apparatus of claim 22, wherein the extracorporeal treatment device is selected from the group consisting of hemodialyzer, hemofilter, hemodiafilter, plasmafilter, and hemoadsorber.

25. An apparatus for monitoring a hydraulic tubing in a blood circuit, comprising:

a. a source for creating pressure pulses in the blood circuit; and

b. a pressure sensor for measuring the pressure pulses, whereby the pressure sensor is mechanically coupled directly to an outer wall of the tubing.

26. An apparatus for detecting stenosis in a blood circuit which is part of an extracorporeal blood treatment system for a patient, the blood circuit comprising an extracorporeal portion and a patient portion, the extracorporeal portion being connected hydraulically to the patient portion with a blood access device, the apparatus comprising:

a. at least one pressure sensor hydraulically connected to the blood circuit;

b. an evaluation unit receiving a measured pressure pulse amplitude proportional signal transmitted by the pressure sensor, said evaluation unit detecting stenosis using a deviation from a predetermined value of the pressure pulse amplitude proportional signal received from the pressure sensor; and

c. a pressure pulse source in the blood circuit creating pressure pulses.