Monitoring of cardiac arrest in a patient connected to an extracorporeal blood processing apparatus

• US 9,895,109 B2
• Filed: 03/17/2014
• Issued: 02/20/2018
• Est. Priority Date: 03/20/2013
• Status: Active Grant

• Current Assignee: Gambro Lundia AB (Baxter International Inc.)
• Original Assignee: Gambro Lundia AB (Baxter International Inc.)
• Inventors: Hansson, Per, Olde, Bo, Solem, Kristian, Sternby, Jan
• Primary Examiner(s): Tejani, Ankit D
• Application Number:
  US14/777,695
• Publication Number:
  US 20160270733A1
• Time in Patent Office: 1,436 Days
• Field of Search: None
• CPC Class Codes: A61B 5/02125 of pulse wave propagation time
• CPC Class Codes: A61B 5/0215 by means inserted into the body catheters A61M25/00
• CPC Class Codes: A61B 5/02158 provided with two or more sensor elements
• CPC Class Codes: A61B 5/4836 Diagnosis combined with treatment in closed-loop systems or methods A61B5/0036 takes precedence
• CPC Class Codes: A61B 5/6866 Extracorporeal blood circuits, e.g. dialysis circuits
• CPC Class Codes: A61B 5/7246 using correlation, e.g. template matching or determination of similarity
• CPC Class Codes: A61B 5/7282 Event detection, e.g. detecting unique waveforms indicative of a medical condition A61B5/4094, A61B5/4818, A61B5/349, A61B5/0823 take precedence
• CPC Class Codes: A61B 5/746 Alarms related to a physiological condition, e.g. details of setting alarm thresholds or avoiding false alarms alarms per se G08B
• 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 1/369 Temperature treatment
• CPC Class Codes: A61M 2230/04 Heartbeat characteristics, e.g. ECG, blood pressure modulation

Abstract

A monitoring device (7) operates an input block (30) to acquire a pressure signal from a pressure sensor (6a-6c) in an apparatus for extracorporeal blood processing connected to the vascular system of the subject. A processing block (34) repeatedly processes the pressure signal for generation of a time-sequence of parameter values indicative of pressure pulsations originating from heartbeats in the subject, and an evaluation block (35) evaluates the parameter values for detection of cardiac arrest and, if cardiac arrest is detected, generates a dedicated alarm signal. To reduce the risk for false positives without increasing the risk for false negatives, the monitoring device (7) may acquire and process more than one pressure signal, and/or perform an initial viability check before the monitoring is initiated to ensure that pressure pulsations originating from heartbeats are detectable in the pressure signal(s), and/or separate the monitoring of the pressure signal(s) into a detection phase performed during regular operation of a blood pump in the apparatus, and a verification phase performed during a temporary shutdown of the blood pump.

Claims

1. A monitoring device, comprising:

an input block configured to obtain a first pressure signal from a first pressure sensor and a second pressure signal from a second pressure sensor, the first and second pressure sensors arranged in an extracorporeal blood processing apparatus to detect pressure variations in a fluid which is pumped through a blood processing unit in the extracorporeal blood processing apparatus, wherein the extracorporeal blood processing apparatus is connected to a vascular system of a subject and includes at least one blood pumping device operable to pump blood from the vascular system through the blood processing unit and back to the vascular system;

a processing block configured to repeatedly process the first pressure signal and the second pressure signal for generation of a time-sequence of parameter values indicative of pressure pulsations originating from heartbeats in the subject; and

an evaluation block configured to (i) evaluate the parameter values according to a detection criterion for cardiac arrest, which is set to detect a disappearance of the pressure pulsations originating from the heartbeats in the first pressure signal and the second pressure signal, and, (ii) if the detection criterion is fulfilled, generate an alarm signal that signals a cardiac arrest in the subject.

2. The monitoring device of claim 1, wherein the first pressure sensor is located on a venous side of an extracorporeal circuit of the extracorporeal blood processing apparatus, and the second pressure sensor is located on an arterial side of the extracorporeal circuit.

3. The monitoring device of claim 1, wherein the monitoring device is further configured to generate an alarm signal for needle dislodgement upon a needle dislodgement, and wherein the alarm signal for cardiac arrest is distinguished from the alarm signal for needle dislodgement.

4. The monitoring device of claim 1, wherein the time-sequence of parameter values includes a time-sequence of first rate values that represent a rate of the pressure pulsations originating from the heartbeats in the first pressure signal, and a time-sequence of second rate values that represent a rate of the pressure pulsations originating from the heartbeats in the second pressure signal, and wherein the detection criterion involves identifying a difference between the first and second rate values.

5. The monitoring device of claim 1, wherein the time-sequence of parameter values includes a time-sequence of correlation values that represent a degree of correlation between the first and second pressure signals, and wherein the detection criterion involves comparing the correlation values to a correlation threshold.

6. The monitoring device of claim 1, wherein the time-sequence of parameter values includes a time-sequence of magnitude values that represent a magnitude of the pressure pulsations originating from the heartbeats in at least the first pressure signal, and wherein the detection criterion involves comparing the magnitude values to a magnitude threshold.

7. The monitoring device of claim 1, wherein the time-sequence of parameter values includes a time-sequence of rate values that represent a rate of the pressure pulsations originating from the heartbeats in at least the first pressure signal;

and wherein the detection criterion involves at least one of;

identifying a sudden change in the time-sequence of rate values;

identifying, based on the time-sequence of rate values, that the rate of the pressure pulsations is substantially equal to a frequency of said at least one blood pumping device; and

identifying, based on the time-sequence of rate values, that the rate of pressure pulsations is outside a predefined range, which defines physiological limits for the rate of heartbeats in the subject.

8. The monitoring device of claim 1, wherein the time-sequence of the parameter values includes a time-sequence of statistical values that represent the shape of at least the first pressure signal and are computed as a statistical measure for signal values within a time window in at least the first pressure signal, and wherein the detection criterion involves comparing the statistical values to a statistics threshold.

9. The monitoring device of claim 1, wherein the evaluation block includes a detection test sub-block and a verification test sub-block, wherein the monitoring device is configured to, during operation of said at least one blood pumping device, cause the detection test sub-block to evaluate the time-sequence of parameter values according to the detection criterion, and wherein the monitoring device is configured to, if the detection criterion is fulfilled, stop said at least one blood pumping device and initiate the verification test sub-block, and wherein the verification test sub-block is configured to, upon said initiation, evaluate at least the first pressure signal for absence of the pressure pulsations originating from heartbeats in the subject when said at least one blood pumping device is stopped and, upon detection of absence of the pressure pulsations, cause the evaluation block to generate the alarm signal that signals a cardiac arrest in the subject.

10. The monitoring device of claim 9, wherein the verification test sub-block is configured to evaluate at least the first pressure signal for absence of the pressure pulsations originating from heartbeats in the subject based on the time sequence of parameter values that are generated by the processing block after said at least one blood pumping device has been stopped.

11. The monitoring device of claim 9, wherein the input block is configured to perform a preparatory filtering to suppress pressure pulsations that originate from said at least one blood pumping device in at least the first pressure signal, and wherein the monitoring device is configured to change or disable the preparatory filtering in the input block when the verification test sub-block is initiated.

12. The monitoring device of claim 9, wherein the detection test sub-block is further configured to, if the detection criterion is fulfilled, evaluate a confidence level of the thus-fulfilled detection criterion, wherein the detection test sub-block is configured to cause the evaluation block to generate the alarm signal if the confidence level is deemed sufficient, and wherein the monitoring device is configured to initiate the verification test sub-block if the confidence level is deemed insufficient.

13. The monitoring device of claim 9, wherein the verification test sub-block is configured to, if being unable to detect absence of the pressure pulsations in at least the first pressure signal, initiate a configuration process for setting the detection criterion based on at least the first pressure signal.

14. The monitoring device of claim 1, which is operable in a viability checking phase to enable the monitoring device for detection of cardiac arrest, wherein the viability checking phase includes:

comparing a magnitude of the pressure pulsations that originate from the heartbeats in at least the first pressure signal to a viability threshold; and

enabling the monitoring device for detection of cardiac arrest provided that the magnitude exceeds the viability threshold.

15. The monitoring device of claim 14, wherein the viability checking phase further includes selecting at least the first pressure signal among a plurality of pressure signals obtained from a plurality of pressure sensors in the extracorporeal blood processing apparatus, based on the magnitude of the pressure pulsations originating from the heartbeats in the respective pressure signal.

16. The monitoring device of claim 14, which is configured to perform the viability checking phase such that said at least one blood pumping device is stopped during at least part of the viability checking phase.

17. The monitoring device of claim 1, wherein the extracorporeal blood processing apparatus is connected to the vascular system via a single access device and is configured to operate in a repeating sequence of a blood withdrawal period in which a first blood pumping device is operated to draw blood from the vascular system via the access device, a blood return period in which a second blood pumping device is operated to pump the blood back to the vascular system via the access device, and a switching period between the blood withdrawal and blood return periods in which the first and second blood pumping devices are stopped, wherein the processing block is configured to generate the time-sequence of parameter values during the switching period, and wherein the evaluation block is configured to evaluate the parameter values generated during the switching period for detection of cardiac arrest.

18. The monitoring device of claim 1, wherein the extracorporeal blood processing apparatus is connected to the vascular system via a single access device and is configured to operate in a repeating sequence of a blood withdrawal period in which said at least one blood pumping device is operated to draw blood from the vascular system via the access device into a container, a blood return period in which said at least one blood pumping device is stopped and the blood flows from the container back into the vascular system via the access device, and wherein the processing block is configured to generate the time-sequence of parameter values during the blood return period, and wherein the evaluation block is configured to evaluate the parameter values generated during the blood return period for detection of cardiac arrest.

19. The monitoring device of claim 1, which is configured to modify the detection criterion as a function of one or more operating parameters of the extracorporeal blood processing apparatus.

20. The monitoring device of claim 1, wherein the first pressure sensor is arranged upstream of the blood processing unit and said at least one blood pumping device in an extracorporeal blood circuit in the extracorporeal blood processing apparatus, and wherein the pressure pulsations originating from heartbeats in the subject are superimposed on a baseline pressure level in the first pressure signal, wherein the evaluation block is configured to generate the alarm signal only in absence of a recent change in the baseline pressure level.

21. The monitoring device of claim 1, wherein the first pressure sensor is one of (i) a pressure sensor arranged downstream of said at least one blood pumping device and the blood processing unit in an extracorporeal blood circuit in the extracorporeal blood processing apparatus, (ii) a pressure sensor arranged upstream of said at least one blood pumping device and the blood processing unit in the extracorporeal blood circuit, and (iii) a pressure sensor arranged in a treatment fluid supply system for pumping a treatment fluid through the blood processing unit.

22. A monitoring device, comprising:

means for obtaining a first pressure signal from a first pressure sensor and a second pressure signal from a second pressure sensor, the first and second pressure sensors arranged in an extracorporeal blood processing apparatus to detect pressure variations in a fluid which is pumped through a blood processing unit in the extracorporeal blood processing apparatus, wherein the extracorporeal blood processing apparatus is connected to a vascular system of a subject and includes at least one blood pumping device operable to pump blood from the vascular system through the blood processing unit and back to the vascular system;

means for repeatedly processing the first pressure signal and the second pressure signal for generation of a time-sequence of parameter values indicative of pressure pulsations originating from heartbeats in the subject;

means for evaluating the parameter values according to a detection criterion for cardiac arrest, which is set to detect a disappearance of the pressure pulsations originating from the heartbeats in the first pressure signal and the second pressure signal; and

means for generating, if the detection criterion is fulfilled, an alarm signal that signals a cardiac arrest in the subject.

23. A monitoring device, comprising:

an input block configured to obtain a first pressure signal from a first pressure sensor and a second pressure signal from a second pressure sensor, the first and second pressure sensors arranged in an extracorporeal blood processing apparatus to detect pressure variations in a fluid which is pumped through a blood processing unit in the extracorporeal blood processing apparatus, wherein the extracorporeal blood processing apparatus is connected to a vascular system of a subject and includes at least one blood pumping device operable to pump blood from the vascular system through the blood processing unit and back to the vascular system; and

a signal processor configured to (i) repeatedly process the first pressure signal and the second pressure signal for generation of a time-sequence of parameter values indicative of pressure pulsations originating from heartbeats in the subject, (ii) evaluate the parameter values according to a detection criterion for cardiac arrest, which is set to detect a disappearance of the pressure pulsations originating from the heartbeats in the first pressure signal and the second pressure signal, and (iii) generate, if the detection criterion is fulfilled, an alarm signal that signals a cardiac arrest in the subject.

24. An apparatus for extracorporeal blood processing, said apparatus comprising:

an extracorporeal blood circuit for connection to the vascular system of a subject;

a blood processing unit in the extracorporeal blood circuit;

at least one blood pumping device in the extracorporeal blood circuit, the at least one blood pumping device operable to pump blood from the vascular system through the blood processing unit and back to the vascular system;

a treatment fluid supply system operable to pump a treatment fluid through the blood processing unit; and

a pressure sensor arranged in one of the extracorporeal blood circuit and the treatment fluid supply system to detect pressure variations in one of the blood and the treatment fluid, said apparatus further comprising the monitoring device as set forth in claim 23.

25. The apparatus of claim 24, further comprising revival equipment for cardiopulmonary resuscitation and/or defibrillation.

26. The apparatus of claim 25, which is operable to activate the revival equipment when the monitoring device has generated the alarm signal that signals a cardiac arrest in the subject.

27. The apparatus of claim 24, which is operable to control the treatment fluid supply system to decrease the temperature of the treatment fluid, so as to decrease the body temperature of the subject, when the monitoring device has generated the alarm signal that signals a cardiac arrest in the subject.

28. The apparatus of claim 24, which is operable to control, when the monitoring device has generated the alarm signal that signals a cardiac arrest in the subject, at least one of the treatment fluid supply system and the extracorporeal blood circuit to change the composition of the blood pumped to the vascular system of the subject.

29. A monitoring method, comprising:

obtaining a first pressure signal from a first pressure sensor and a second pressure signal from a second pressure sensor, the first and second pressure sensors arranged in an extracorporeal blood processing apparatus to detect pressure variations in a fluid which is pumped through a blood processing unit in the extracorporeal blood processing apparatus, wherein the extracorporeal blood processing apparatus is connected to a vascular system of a subject and includes at least one blood pumping device operable to pump blood from the vascular system through the blood processing unit and back to the vascular system;

processing the first pressure signal and the second pressure signal for generation of a time-sequence of parameter values indicative of pressure pulsations originating from heartbeats in the subject;

evaluating the parameter values according to a detection criterion for cardiac arrest, which is set to detect a disappearance of the pressure pulsations originating from the heartbeats in the first pressure signal and the second pressure signal; and

generating, if the detection criterion is fulfilled, an alarm signal that signals a cardiac arrest in the subject.

30. The monitoring method of claim 29, wherein the first pressure sensor is arranged on a venous side of an extracorporeal circuit of the extracorporeal blood processing apparatus, and wherein the second pressure sensor is arranged on an arterial side of the extracorporeal circuit.

31. The monitoring method of claim 29, which includes generating an alarm signal for needle dislodgement upon a of needle dislodgement, and wherein the alarm signal for cardiac arrest is distinguished from the alarm signal for needle dislodgement.

32. The monitoring method of claim 29, wherein the time-sequence of parameter values includes a time-sequence of first rate values that represent a rate of the pressure pulsations originating from the heartbeats in the first pressure signal, and a time-sequence of second rate values that represent a rate of the pressure pulsations originating from the heartbeats in the second pressure signal;

and wherein the detection criterion involves identifying a difference between the first and second rate values.

33. The monitoring method of claim 29, wherein the time-sequence of parameter values includes a time-sequence of correlation values that represent a degree of correlation between the first and second pressure signals, and wherein the detection criterion involves comparing the correlation values to a correlation threshold.

34. The monitoring method of claim 29, wherein the time-sequence of parameter values includes a time-sequence of magnitude values that represent a magnitude of the pressure pulsations originating from the heartbeats in at least the first pressure signal, and wherein the detection criterion involves comparing the magnitude values to a magnitude threshold.

35. The monitoring method of claim 29, wherein the time-sequence of parameter values includes a time-sequence of rate values that represent a rate of the pressure pulsations originating from the heartbeats in at least the first pressure signal;

and wherein the detection criterion involves at least one of;

(i) identifying a sudden change in the time-sequence of rate values;

identifying, based on the time-sequence of rate values, that the rate of the pressure pulsations is substantially equal to a frequency of said at least one blood pumping device;

or (ii) identifying, based on the time-sequence of rate values, that the rate of pressure pulsations is outside a predefined range, which preferably defines physiological limits for the rate of heartbeats in the subject.

36. The monitoring method of claim 29, wherein the time-sequence of parameter values includes a time-sequence of statistical values that represent the shape of at least the first pressure signal and are computed as a statistical measure for signal values within a time window in at least the first pressure signal, and wherein the detection criterion involves comparing the statistical values to a statistics threshold.

37. The monitoring method of claim 29, which is operable in a detection phase, in which the time-sequence of parameter values is evaluated according to the detection criterion during operation of said at least one blood pumping device, wherein the monitoring method further comprises, if the detection criterion is fulfilled, stopping said at least one blood pumping device and entering a verification phase, in which at least the first pressure signal is evaluated for absence of the pressure pulsations originating from heartbeats in the subject, and wherein the alarm signal is generated if the verification phase indicates an absence of the pressure pulsations originating from heartbeats in the subject.

38. The monitoring method of claim 37, wherein the verification phase evaluates at least the first pressure signal for absence of the pressure pulsations originating from heartbeats in the subject based on the time sequence of parameter values that are generated by the step of processing after said at least one blood pumping device has been stopped.

39. The monitoring method of claim 37, wherein at least the first pressure signal is subjected to a preparatory filtering during the detection phase to suppress pressure pulsations that originate from said at least one blood pumping device, and wherein the filtering is changed or disabled during the verification phase.

40. The monitoring method of claim 37, wherein the detection phase further includes, if the detection criterion is fulfilled, a step of evaluating a confidence level of the thus-fulfilled detection criterion, wherein the alarm signal is generated if the confidence level is deemed sufficient, and wherein the monitoring method enters the verification phase if the confidence level is deemed insufficient.

41. The monitoring method of claim 37, wherein the verification phase, if unable to indicate an absence of the pressure pulsations originating from heartbeats in the subject, initiates a configuration process for setting the detection criterion based on at least the first pressure signal.

42. The monitoring method of claim 37, which is operable in a viability checking phase to enable the monitoring method for detection of cardiac arrest, wherein the viability checking phase includes:

comparing a magnitude of the pressure pulsations that originate from the heartbeats in at least the first pressure signal to a viability threshold; and

enabling the monitoring method for detection of cardiac arrest provided that the magnitude exceeds the viability threshold.

43. The monitoring method of claim 42, which executes the viability checking phase such that said at least one blood pumping device is stopped during at least part of the viability checking phase.

44. The monitoring method of claim 29, further comprising:

selecting at least the first pressure signal among a plurality of pressure signals obtained from a plurality of pressure sensors in the extracorporeal blood processing apparatus, based on a magnitude of the pressure pulsations originating from the heartbeats in the respective pressure signal.

45. The monitoring method of claim 29, wherein the extracorporeal blood processing apparatus is connected to the vascular system via a single access device and operates in a repeating sequence of a blood withdrawal period in which a first blood pumping device is operated to draw blood from the vascular system via the access device, a blood return period in which a second blood pumping device is operated to pump the blood back to the vascular system via the access device, and a switching period between the blood withdrawal and blood return periods in which the first and second blood pumping devices are stopped, wherein the monitoring method generates the time-sequence of parameter values during the switching period, and evaluates the parameter values that are generated during the switching period for detection of cardiac arrest.

46. The monitoring method of claim 29, wherein the extracorporeal blood processing apparatus is connected to the vascular system via a single access device and is configured to operate in a repeating sequence of a blood withdrawal period in which said at least one blood pumping device is operated to draw blood from the vascular system via the access device into a container, a blood return period in which said at least one blood pumping device is stopped and the blood flows from the container back into the vascular system via the access device, and wherein the monitoring method generates the time-sequence of parameter values during the blood return period, and evaluates the parameter values generated during the blood return period for detection of cardiac arrest.

47. The monitoring method of claim 29, further comprising a step of modifying the detection criterion as a function of one or more operating parameters of the extracorporeal blood processing apparatus.

48. The monitoring method of claim 29, wherein the first pressure sensor is arranged upstream of the blood processing unit and said at least one blood pumping device in an extracorporeal blood circuit in the extracorporeal blood processing apparatus, and wherein the pressure pulsations originating from heartbeats in the subject are superimposed on a baseline pressure level in the first pressure signal, wherein the alarm signal is generated only in absence of a recent change in the baseline pressure level.

49. A computer-readable medium comprising computer instructions which, when executed by a processor, cause the processor to perform the method of claim 29.