MONITORING SYSTEM FOR CARDIAC SURGICAL OPERATIONS WITH CARDIOPULMONARY BYPASS

• US 20150272487A1
• Filed: 06/12/2015
• Published: 10/01/2015
• 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
• Granted Patent: US 10,039,490 B2
• Time in Patent Office: Days
• US Class Current: 1/1
• 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 with a heart-lung machine having a pump and an oxygenator fluidly coupled to the heart-lung machine, the monitoring system comprising:

a controller configured to;

receive a hematocrit value of a patient in real-time during a cardiopulmonary bypass procedure, the hematocrit value being continuously measured by a hematocrit sensor;

receive a pump flow rate value of the pump in real-time during the cardiopulmonary bypass procedure, the pump flow rate value being continuously measured by a pump flow rate sensor;

receive an arterial oxygen saturation value of the patient;

calculate an oxygen delivery value in real-time during the cardiopulmonary bypass procedure based on each of the arterial oxygen saturation value, the real-time hematocrit value, and the real-time pump flow rate value; and

compare the calculated oxygen delivery value against an oxygen delivery value threshold; and

a display device operably connected to the controller and configured to display each of the arterial oxygen saturation value, the hematocrit value, the pump flow rate value, and the calculated real-time oxygen delivery value.

2. The monitoring system of claim 1, wherein the controller is further configured to trigger an alarm if the calculated oxygen delivery value is within a designated proximity to the oxygen delivery value threshold.

3. The monitoring system of claim 2, wherein the designated proximity is an oxygen delivery value that is less than the oxygen delivery value threshold.

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

5. The monitoring system of claim 4, wherein the oxygen delivery value threshold is based, at least in part, on a body surface area of the patient.

6. The monitoring system of claim 5, wherein the oxygen delivery value threshold is based, at least in part, on each of the temperature value of the patient and the body surface area of the patient.

7. The monitoring system of claim 8, wherein for a first temperature value of the patient, the oxygen delivery value threshold is a first value and for a second, different temperature value of the patient, the oxygen delivery value threshold is a second, different value.

8. The monitoring system of claim 1, wherein the controller is further configured to determine an accumulated amount of time at which the calculated oxygen delivery value is within a designated proximity to the oxygen delivery value threshold.

9. The monitoring system of claim 8, wherein if the accumulated amount of time reaches a predetermined threshold amount of time, the controller is configured to trigger an alarm.

10. 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 oxygen consumption value in real-time during the cardiopulmonary bypass procedure based on each of the arterial oxygen saturation value, the venous oxygen saturation value, the real-time hematocrit value, and the real-time pump flow rate value.

11. A method of monitoring a patient during a cardiac operation with a heart-lung machine having a pump and an oxygenator fluidly coupled to the heart-lung machine, the method comprising:

receiving a real-time hematocrit value of the patient;

receiving a real-time pump flow rate value of the pump;

receiving an arterial oxygen saturation value of the patient;

receiving a venous oxygen saturation value of the patient;

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

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

causing at least one display device to display each of the arterial oxygen value, the hematocrit value, the pump flow rate value, and the calculated real-time oxygen delivery value.

12. The method of claim 11, further comprising causing the at least one controller to trigger an alarm if the calculated oxygen delivery value is within a designated proximity to the oxygen delivery value threshold.

13. The method of claim 12, wherein the designated proximity is an oxygen delivery value that is less than the oxygen delivery value threshold.

14. The method of claim 12, further comprising receiving a temperature value of the patient.

15. The method of claim 14, wherein the oxygen delivery value threshold is based, at least in part, on a body surface area of the patient.

16. The method of claim 15, wherein the oxygen delivery value threshold is based, at least in part, on each of the temperature value of the patient and the body surface area of the patient.

17. The method of claim 16, wherein for a first temperature value of the patient, the oxygen delivery value threshold is a first value and for a second, different temperature value of the patient, the oxygen delivery value threshold is a second, different value.

18. The method of claim 11, further comprising causing the at least one controller to determine an accumulated amount of time at which the calculated oxygen delivery value is within a designated proximity to the oxygen delivery value threshold.

19. The method of claim 18, wherein if the accumulated amount of time reaches a predetermined threshold amount of time, causing the controller to trigger an alarm.

20. The method of claim 11, further comprising:

receiving a venous oxygen saturation value of a patient; and

causing the at least one controller to calculate an oxygen consumption value in real-time during the cardiopulmonary bypass procedure based on each of the arterial oxygen saturation value, the venous oxygen saturation value, the hematocrit value, and the pump flow rate value.