Monitoring system for cardiac surgical operations with cardiopulmonary bypass

• US 10,039,490 B2
• Filed: 06/12/2015
• Issued: 08/07/2018
• Est. Priority Date: 05/13/2005
• Status: Active Grant

• Current Assignee: Sorin Group Italia SRL (LivaNova Plc)
• Original Assignee: Sorin Group Italia SRL (LivaNova Plc)
• Inventors: Ranucci, Marco
• Primary Examiner(s): Mallari, Patricia
• Assistant Examiner(s): TOTH, KAREN E
• Application Number:
  US14/738,805
• Publication Number:
  US 20150272487A1
• Time in Patent Office: 1,152 Days
• CPC Class Codes: A61B 2505/05 Surgical care
• CPC Class Codes: A61B 5/01 Measuring temperature of body parts ; Diagnostic temperature sensing, e.g. for malignant or inflamed tissue clinical contact thermometers G01K13/20
• CPC Class Codes: A61B 5/0205 Simultaneously evaluating both cardiovascular conditions and different types of body conditions, e.g. heart and respiratory condition
• CPC Class Codes: A61B 5/0816 Measuring devices for examining respiratory frequency measuring frequency of electric signals G01R23/00
• CPC Class Codes: A61B 5/082 Evaluation by breath analysis, e.g. determination of the chemical composition of exhaled breath A61B5/083, A61B5/091 take precedence
• CPC Class Codes: A61B 5/14535 for measuring haematocrit
• CPC Class Codes: A61B 5/14542 for measuring blood gases A61B5/14551 takes precedence
• CPC Class Codes: A61B 5/14546 for measuring analytes not otherwise provided for, e.g. ions, cytochromes
• CPC Class Codes: A61B 5/4866 Evaluating metabolism A61B5/083 takes precedence
• CPC Class Codes: A61B 5/6866 Extracorporeal blood circuits, e.g. dialysis circuits
• CPC Class Codes: A61B 5/7278 Artificial waveform generation or derivation, e.g. synthesising signals from measured signals A61B5/327 takes precedence
• CPC Class Codes: A61B 5/742 using visual displays A61B5/339 takes 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 1/14 Dialysis systems; Artificial kidneys; Blood oxygenators semi-permeable membranes characterised by the material, manufacturing processes therefor B01D71/00 ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis
• CPC Class Codes: A61M 1/32 Oxygenators without membranes
• CPC Class Codes: A61M 1/3621 Extra-corporeal blood circuits single-needle circuits A61M1/30
• CPC Class Codes: A61M 1/3666 Cardiac or cardiopulmonary bypass, e.g. heart-lung machines
• CPC Class Codes: A61M 2230/20 Blood composition characteristics
• CPC Class Codes: A61M 2230/205 partial oxygen pressure (P-O2)
• CPC Class Codes: A61M 2230/207 hematocrit
• CPC Class Codes: G01N 33/4925 : measuring blood gas content, e.g. O2, CO2 , HCO3
• CPC Class Codes: G16H 20/00 : ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance
• CPC Class Codes: G16H 40/60 : for the operation of medical equipment or devices
• CPC Class Codes: G16H 40/63 : for local operation
• CPC Class Codes: G16H 50/30 : for calculating health indices; for individual health risk assessment
• CPC Class Codes: G16Z 99/00 : Subject matter not provided for in other main groups of this subclass

Abstract

A monitoring system for cardiac operations with cardiopulmonary bypass comprising: a processor operatively connected to a heart-lung machine; a pump flow detecting device connected to a pump of the heart-lung machine to continuously measure the pump flow value and send it to the processor; a hematocrit reading device to continuously measure the blood hematocrit value and to send it to the processor; a data input device to allow the operator to manually input data regarding the arterial oxygen saturation and the arterial oxygen tension; computing means integrated in the processor to compute the oxygen delivery value on the basis of the measured pump flow, the measured hematocrit value, the preset value of arterial oxygen saturation, and the preset value of arterial oxygen tension; and a display connected to the processor to display in real-time the computed oxygen delivery value.

Claims

1. A monitoring system for cardiac operations with cardiopulmonary bypass, the monitoring system comprising:

a controller configured to;

receive a hematocrit and/or hemoglobin value of a patient,

receive a pump flow rate value,

receive an arterial oxygen saturation value of the patient,

calculate an indexed oxygen delivery value based on at least each of the arterial oxygen saturation value, the hematocrit and/or hemoglobin value, a body surface area of the patient, and the pump flow rate value,

compare the calculated indexed oxygen delivery value against an indexed oxygen delivery value threshold, and

trigger an alarm if the calculated indexed oxygen delivery value is below the indexed oxygen delivery value threshold; and

a display operably coupled to the controller, the display configured to display;

in a first window of the display, the calculated indexed oxygen delivery value, and

in a plurality of windows positioned at least partially around the first window, values of physiological parameters of the patient and parameters of the monitoring system including the pump flow rate value.

2. The monitoring system of claim 1, wherein the controller is further configured to receive a temperature value of the patient.

3. The monitoring system of claim 2, wherein the indexed oxygen delivery value threshold is based, at least in part, on the temperature value of the patient.

4. The monitoring system of claim 3, wherein for a first temperature value of the patient, the indexed oxygen delivery value threshold is a first value and for a second, different temperature value of the patient, the indexed oxygen delivery value threshold is a second, different value.

5. The monitoring system of claim 1, wherein the controller is further configured to determine an accumulated amount of time at which the calculated indexed oxygen delivery value is below the indexed oxygen delivery value threshold.

6. The monitoring system of claim 5, wherein if the accumulated amount of time reaches a predetermined accumulated amount of time threshold, the controller is configured to trigger an alarm.

7. The monitoring system of claim 1, wherein the controller is further configured to:

receive a venous oxygen saturation value of the patient; and

calculate an indexed oxygen consumption value based on each of the arterial oxygen saturation value, the venous oxygen saturation value, the hematocrit and/or hemoglobin value, and the pump flow rate value,

wherein one of the values physiological parameters of the patient displayed in the plurality of windows the venous oxygen saturation value.

8. The monitoring system of claim 1, wherein the monitoring system includes a manual data input device to allow an operator to manually input data.

9. A method of monitoring a patient during a cardiac operation, the method comprising:

receiving at least one of a real-time hematocrit value of the patient and a real-time hemoglobin value of the patient;

receiving a real-time pump flow rate value;

receiving an arterial oxygen saturation value of the patient;

causing at least one controller to calculate an indexed oxygen delivery value in real-time based on each of the arterial oxygen value, the at least one of a real-time hematocrit value and a real-time hemoglobin value, a body surface area of the patient, and the real-time pump flow rate value;

causing the at least one controller to compare the calculated real-time indexed oxygen delivery value against an indexed oxygen delivery value threshold;

displaying, as a function of time, via a display, the calculated indexed oxygen delivery value in a first window of the display that is at least partially surrounded by a plurality of windows of the display;

displaying the real-time value of the pump flow rate value in one of the plurality of windows; and

displaying the at least one of a real-time hematocrit value and a real-time hemoglobin value in one of the plurality of windows.

10. The method of claim 9, further comprising:

determining, by the at least one controller, that the calculated real-time indexed oxygen delivery value is below the indexed oxygen delivery value threshold; and

causing the at least one controller to trigger an alarm in response to determining that the calculated real-time indexed oxygen delivery value is below the indexed oxygen delivery value threshold.

11. The method of claim 10, further comprising receiving a temperature value of the patient.

12. The method of claim 11, wherein the indexed oxygen delivery value threshold is based, at least in part, on the temperature value of the patient.

13. The method of claim 12, wherein for a first temperature value of the patient, the indexed oxygen delivery value threshold is a first value and for a second, different temperature value of the patient, the indexed oxygen delivery value threshold is a second, different value.

14. The method of claim 9, further comprising causing the at least one controller to determine an accumulated amount of time at which the calculated real-time indexed oxygen delivery value is below the indexed oxygen delivery value threshold.

15. The method of claim 14, wherein if the accumulated amount of time reaches a predetermined threshold amount of time, causing the controller to trigger an alarm.

16. The method of claim 9, further comprising:

receiving a real-time venous oxygen saturation value of the patient; and

causing the at least one controller to calculate an oxygen consumption value in real-time based on each of the arterial oxygen saturation value, the real-time venous oxygen saturation value, the at least one of a real-time hematocrit value and a real-time hemoglobin value, and the real-time pump flow rate value; and

causing the display to display the real-time venous oxygen saturation value in one of the plurality of windows.

17. The method of claim 9, wherein the indexed oxygen delivery threshold is one of a threshold associated with hypoxic organ dysfunction, a threshold associated with hypoxemia, and a threshold associated with lactic acidosis.

18. The method of claim 9, wherein receiving an arterial oxygen saturation value comprises receiving one of a preset arterial oxygen saturation value, a manually input arterial oxygen saturation value, and a calculated arterial oxygen saturation value.

19. A monitoring system for cardiac operations with cardiopulmonary bypass, the monitoring system comprising:

a controller configured to;

receive a pump flow rate value of a pump,

receive an arterial oxygen value of a patient,

receive a venous oxygen value of the patient,

calculate an indexed oxygen delivery value in response to at least the received pump flow rate value being multiplied by the arterial oxygen value and divided by a body surface area of the patient, the arterial oxygen value being based at least in part on a hematocrit value or hemoglobin value of the patient,

calculate an indexed oxygen consumption value in response to at least the received pump flow rate being divided by a body surface area of the patient and multiplied by a number calculated by subtracting the venous oxygen value from the arterial oxygen value,

compare the calculated indexed oxygen delivery value to an indexed oxygen delivery value threshold, compare the calculated indexed oxygen consumption value to an anaerobic threshold, and

trigger an alarm based on the occurrence of the calculated indexed oxygen delivery value falling below the indexed oxygen delivery value threshold or the calculated indexed oxygen consumption value exceeding the anaerobic threshold; and

a display operably connected to the controller and configured to display;

in a first window of the display, the calculated indexed oxygen delivery value and the calculated indexed oxygen consumption value, and

in a plurality of windows positioned at least partially around the first window, values of physiological parameters of the patient.

20. The monitoring system of claim 19, wherein the controller is further configured to determine an accumulated amount of time in which the calculated indexed oxygen delivery value is below the indexed oxygen delivery value threshold.

21. The monitoring system of claim 20, wherein if the accumulated amount of time reaches a predetermined accumulated amount of time threshold, the controller is configured to trigger an alarm.