Method and device for recognition of paravasal bleeding

• US 8,439,857 B2
• Filed: 11/14/2009
• Issued: 05/14/2013
• Est. Priority Date: 11/19/2008
• Status: Active Grant

• Current Assignee: Fresenius Medical Care Deutschland GmbH (Fresenius Medical Care AG)
• Original Assignee: Fresenius Medical Care Deutschland GmbH (Fresenius Medical Care AG)
• Inventors: Kopperschmidt, Pascal, Gross, Malte, Spickermann, Reiner
• Primary Examiner(s): Hand, Melanie J
• Assistant Examiner(s): Lo, Andrew S
• Application Number:
  US13/130,116
• Publication Number:
  US 20110230812A1
• Time in Patent Office: 1,277 Days
• Field of Search: None
• US Class Current: 604/4.01
• CPC Class Codes: A61B 5/02042 Determining blood loss or bleeding, e.g. during a surgical procedure
• CPC Class Codes: A61M 1/3639 Blood pressure control, pressure transducers specially adapted therefor
• CPC Class Codes: A61M 1/3653 Interfaces between patient blood circulation and extra-corporal blood circuit
• CPC Class Codes: A61M 1/3656 Monitoring patency or flow at connection sites; Detecting disconnections
• CPC Class Codes: A61M 1/3659 Cannulae pertaining to extracorporeal circulation
• CPC Class Codes: A61M 1/3661 for haemodialysis
• CPC Class Codes: A61M 2205/18 with alarm
• CPC Class Codes: A61M 2205/3331 Pressure; Flow

Abstract

A method and a device for recognition of paravasal bleeding upon a supplying of blood to a vascular access via a line and/or upon the removal of blood from a vascular access via a line is provided. A device for extracorporeal blood treatment comprising a device for recognition of paravasal bleeding is also provided. The method and the device are based on the change of arterial pressure in the arterial branch or the venous pressure in the venous branch of the extra-corporeal circuit being registered during the extracorporeal blood treatment. One aspect of the method and the device is that pressure changes that come from a pressure level exhibiting a large difference from a reference value are more strongly considered than those that come from a pressure level that exhibits only a minor difference from the reference value.

Claims

1. A method of detecting perivascular bleeding when blood is being fed to and/or taken away from a vascular access via at least one line, the pressure being measured in the at least one line, the method comprising:

determining a value of a non-linear function of the difference between the measured pressure and a preset reference value;

comparing the value of the non-linear function with a preset limiting value; and

determining that there is perivascular bleeding based on an exceeding of the limiting value by the value of the non-linear function.

2. The method according to claim 1, further comprising:

determining an exponentially raised value of the difference between the measured pressure and the preset reference value by raising the difference to an exponential power;

comparing the exponentially raised value of the difference in pressure with the preset limiting value; and

determining that there is perivascular bleeding based on an exceeding of the limiting value by the exponentially raised value of the difference in pressure.

3. The method according to claim 1, further comprising:

determining an exponentially raised value of the absolute value of the difference between the pressure measured in the line and the preset reference value by raising the absolute value to an exponential power;

comparing the exponential value of the absolute value of the difference in pressure with the preset limiting value; and

determining that there is perivascular bleeding based on an exceeding of the limiting value by the exponentially raised value of the absolute value of the difference in pressure.

10. The method according to claim 1, further comprising providing a visual and/or audio alarm in response to the determination of perivascular bleeding.

11. The method according to claim 1, further comprising interrupting the flow of blood in response to the determination of perivascular bleeding.

25. The method of claim 1, wherein the at least one line is a single line, and the measured pressure is the pressure measured in that single line.

4. A method of detecting perivascular bleeding during an extra-corporeal blood treatment in which blood flows from an arterial vascular access via an arterial segment of an extra-corporeal blood circuit into a blood treatment device and from the blood treatment device via a venous segment of the extra-corporeal blood circuit to a venous vascular access, the arterial pressure in the arterial segment of the extra-corporeal blood circuit and/or the venous pressure in its venous segment being measured, the method further comprising:

determining at least one of (a) a first value, of a non-linear function of the difference between the arterial pressure which is measured and a preset reference value for the arterial pressure and (b) a second value, of a non-linear function of the difference between the venous pressure which is measured and a preset reference value for the venous pressure;

at least one of (a) comparing the first value with a first limiting value and (b) comparing the second value with a second limiting value; and

determining that there is perivascular bleeding based on (a) the first limiting value being exceeded and/or (b) the second limiting value being exceeded.

5. The method according to claim 4, further comprising:

determining (a) a first exponentially raised value corresponding to the absolute value, raised to a exponential power, of the difference between the measured arterial pressure and a preset reference value for the arterial pressure and/or (b) a second exponentially raised value, corresponding to the absolute value, raised to an exponential power, of the difference between the measured venous pressure and a preset reference value for the venous pressure; and

at least one of (a) comparing the first exponentially raised value with a first limiting value and (b) comparing the second exponentially raised value with a second limiting value; and

determining that there is perivascular bleeding based on (a) the first limiting value being exceeded by the first exponentially raised value and/or (b) second limiting value being exceeded by the second exponentially raised value.

6. Method according to claim 4, further comprising:

determining, over a preset time interval t₂−

t₁, an exponentially raised value corresponding to the absolute value, raised to an exponential power, of the difference between the measured arterial pressure and a preset reference value for the arterial pressure;

comparing the exponentially raised value with a preset limiting value; and

determining that there is perivascular bleeding based on the preset limiting value being exceeded by the exponentially raised value.

7. The method according to claim 4, further comprising:

determining, over a preset time interval t₂−

t₁, an integral value in the form of an integral of the absolute value, raised to an exponential power, of the difference between the measured venous pressure and a preset reference value for the venous pressure;

comparing the integral value with a preset limiting value; and

determining that there is perivascular bleeding based on the preset limiting value being exceeded by the integral value.

8. The method according to claim 5, wherein (a) the first exponential value corresponds to the absolute value, raised to an exponential power of two, three or four, of the difference between the measured arterial pressure and a preset reference value for the arterial pressure and/or (b) the second exponential value corresponds to the absolute value, raised to an exponential power of two, three, or four, of the difference between the measured venous pressure and a preset reference value for the venous pressure.

9. The method according to claim 5, wherein (a) the first exponential value corresponds to the absolute value, raised to an exponential power of three, of the difference between the measured arterial pressure and a preset reference value for the arterial pressure and/or (b) the second exponential value corresponds to the absolute value, raised to an exponential power of three, of the difference between the measured venous pressure and a preset reference value for the venous pressure.

12. An arrangement for detecting perivascular bleeding when blood is being fed to and/or taken away from a vascular access via at least one line, the pressure being measured in the at least one line, the arrangement for detecting perivascular bleeding including means of measuring the pressure in the at least one line, the arrangement comprising:

an analyzing and calculating unit configured to (a) determine a non-linear function of the difference between a measured pressure and a preset reference value, (b) compare the value of the non-linear function with a preset limiting value, and (c) determine that there is perivascular bleeding based on the limiting value being exceeded.

13. The arrangement according to claim 12, wherein the analyzing and calculating unit is further configured to (a) determine an exponentially raised value of the difference between the measured pressure and the preset reference value, (b) compare the exponentially raised value of the difference with the preset limiting value, and (c) determine that there is perivascular bleeding based on the limiting value being exceeded by the exponentially raised value.

14. The arrangement according to claim 12, wherein the analyzing and calculating unit is configured to (a) determine an exponentially raised value corresponding to the absolute value, raised to an exponential power, of the difference between the measured pressure and the preset reference value, (b) compare the exponentially raised value with the preset limiting value, and (c) determine that there is perivascular bleeding based on the limiting value being exceeded by the exponentially raised value.

26. The arrangement according to claim 12, wherein the at least one line is a single line, and the measured pressure is the pressure measured in that single line.

15. An arrangement for detecting perivascular bleeding during extra-corporeal blood treatment by an extra-corporeal blood treatment apparatus, the extra-corporeal blood treatment apparatus including (a) an arterial blood line belonging to an extra-corporeal blood circuit, which arterial blood line is connected to the inlet of a blood treating means at one end and is provided with an arterial connection for an arterial vascular access at the other end, (b) a venous blood line belonging to the extra-corporeal blood circuit, the venous blood line being connected to the outlet of the blood treating means at one end and is provided with a venous connection for a venous vascular access at the other end, and (c) means for measuring the arterial pressure in the arterial segment of the extra-corporeal blood circuit and/or the venous pressure in its venous segment, the arrangement comprising:

an analyzing and calculating unit configured to (a) determine a first value, of a non-linear function of the difference between the measured arterial pressure and a preset reference value for the arterial pressure and/or determine a second value, of a non-linear function of the difference between the measured venous pressure and a preset reference value for the venous pressure, (b) compare the first value with a first preset limiting value and/or compare the second value with a second preset limiting value, and (c) determine that there is perivascular bleeding based on the first limiting value and/or the second limiting value being exceeded.

16. The arrangement according to claim 15, wherein the analyzing and calculating unit is configured to (a) determine a first exponentially raised value corresponding to the absolute value, raised to an exponential power, of the difference between the measured arterial pressure and a preset reference value for the arterial pressure and/or determine a second exponentially raised value corresponding to the absolute value, raised to an exponential power, of the difference between the measured venous pressure and a preset reference value for the venous pressure, (b) compare the first exponentially raised value with a first preset limiting value and/or compare the second exponentially raised value with a second preset limiting value, and (c) concluding that there is perivascular bleeding based on the first limiting value being exceeded by the first exponentially raised value and/or the second limiting value being exceeded by the second exponentially raised value.

17. The arrangement according to claim 16, wherein the analyzing and calculating unit includes:

means for calculating (a) a first integral value, in the form of an integral of the absolute value of the difference between the measured arterial pressure and a reference value for the arterial pressure, over a preset interval of time t₂−

t₁, and/or (b) a second integral value, in the form of an integral of the absolute value of the difference between the measured venous pressure and a reference value for the venous pressure, over a preset interval of time t₂−

t₁, and

means for comparing the first integral value with a first preset limiting value and/or the second integral value with a second preset limiting value.

18. The arrangement according to claim 17, wherein the analyzing and calculating unit is configured to determine (a) the value, raised to an exponential value of two, three, or four, of the difference between the arterial pressure which is measured and a preset reference value for the arterial pressure or (b) the value, raised to an exponential power of two, three, or four, of the difference between the measured venous pressure and a preset reference value for the venous pressure.

19. The arrangement according to claim 17, wherein the analyzing and calculating unit is configured to determine (a) the value, raised to an exponential power of three, of the difference between the arterial pressure which is measured and a preset reference value for the arterial pressure or (b) the value, raised to the exponential power of three, of the difference between the measured venous pressure and a preset reference value for the venous pressure.

20. The arrangement according to claim 15, further comprising an alarm unit configured to provide a visual and/or audio alarm when the presence of perivascular bleeding is determined.

21. The arrangement according to claim 15, further comprising means for generating a control signal for interrupting the flow of blood in response to the determination of perivascular bleeding.

22. The arrangement according to claim 15, further comprising means for generating a control signal for interrupting the flow of blood in the extra-corporeal blood treating apparatus in response to the determination of perivascular bleeding.

23. An extra-corporeal blood treating apparatus, comprising:

an arterial blood line of an extra-corporeal blood circuit, the blood line being (a) connected to an inlet of a blood treating means at one end and (b) provided with an arterial connection for an arterial vascular access at the other end,

a venous blood line of the extra-corporeal blood circuit, the venous blood line being (a) connected to an outlet of the blood treating means at one end and (b) provided with a venous connection for a venous vascular access at the other end, and

means for measuring (a) the arterial pressure in the arterial segment of the extra-corporeal blood circuit and/or (b) the venous pressure in the venous segment of the extra-corporeal blood circuit, and

an arrangement according to claim 15.

24. The extra-corporeal blood treating apparatus according to claim 23, further comprising means for interrupting the flow of blood in the extra-corporeal blood circuit.