Monitoring, system for cardiac surgical operations with cardiopulmonary bypass

• US 20060257283A1
• Filed: 05/11/2006
• Published: 11/16/2006
• 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 7,435,220 B2
• Time in Patent Office: Days
• US Class Current: 422/45
• 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 inserted inside the arterial or venous line of the heart-lung machine 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 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 (Qp) and send it to the processor;

a hematocrit reading device inserted inside the arterial or venous line of the heart-lung machine to continuously measure the blood hematocrit (HCT) 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 (Sat(a)) and the arterial oxygen tension (PaO2);

computing means integrated in the processor to compute the oxygen delivery (DO2i) value on the basis of the measured pump flow (Qp), the measured hematocrit (HCT) value, the preset value of arterial oxygen saturation (Sat(a)), and the preset value of arterial oxygen tension (PaO2); and

a display connected to the processor to display in real-time the computed oxygen delivery (DO2i) value.

2. A monitoring system according to the claim 1, further comprising:

comparing means to compare the above mentioned oxygen delivery (DO2i) value with a threshold value of oxygen delivery (DO2i_crit); and

an alarm which is triggered when the oxygen delivery (DO2i) value falls below the threshold value of oxygen delivery (DO2i_crit).

3. A monitoring system according to the claim 2, wherein the threshold value of oxygen delivery (DO2i_crit) is preset by the operator at a value of about 270 ml/min/m².

4. A monitoring system according to claim 1, further comprising a temperature detecting device able to continuously measure the body temperature (T) of the patient and to send the temperature values to the processor, to be subsequently displayed by the display.

5. A monitoring system according to claim 4, further comprising an oxygen delivery threshold computing means, receiving as input the temperature (T) value of the patient as detected.

6. A monitoring system according to claim 1, wherein the processor includes a hemoglobin value computing means able to calculate the hemoglobin (Hb) value from the detected hematocrit (HCT) value, and to send it to the oxygen delivery computing means, to be subsequently displayed in the display.

7. A monitoring system according to claim 1, wherein the processor includes a computing means able to calculate the indexed pump flow (Qpi) from the pump flow (Qp) and the value of body surface area (BSA) of the patient.

8. A monitoring system according to claim 2, wherein the data input device allows the operator to manually input data regarding the weight and height of the patient so that the computing means is able to compute the body surface area (BSA) of the patient.

9. A monitoring system according to claim 1, wherein the pump flow detecting device includes a Doppler reading cell.

10. A monitoring system for cardiac operations with cardiopulmonary bypass comprising:

a processor operatively connected to a heart-lung machine;

a CO2 detecting device placed at the oxygenator of the heart-lung machine to continuously detect the exhaled CO2 (eCO2) value and send it to the processor;

a data input device allowing the operator to manually input data regarding the gas flow (Ve) of the heart-lung machine;

computing means able to calculate the CO2 production (VCO2i) from the preset gas flow (Ve) and the exhaled CO2 (eCO2) detected; and

a display connected to the processor to display in real-time the above CO2 production (VCO2i) as calculated.

11. A monitoring system according to claim 10, further comprising:

comparison means to compare the above CO2 production (VCO2i) calculated value with a CO2 production threshold value (VCO2i_crit); and

an alarm that is triggered whenever the CO2 production (VCO2i) value exceeds the CO2 production threshold value (VCO2i_crit).

12. A method of monitoring a patient'"'"'s parameters during a cardiac operation with cardiopulmonary bypass and a heart-lung machine, the method comprising:

continuously detecting the pump flow (Qp) from a pump of the heart-lung machine;

continuously detecting the hematocrit (HCT) value from the arterial or venous line of the heart-lung machine;

setting an arterial oxygen saturation (Sat(a)) value derived from the arterial blood of the patient;

setting an arterial oxygen tension (PaO2) value derived from the arterial blood of the patient;

computing the oxygen delivery (DO2i) of the patient from the detected and set values; and

displaying the oxygen delivery (DO2i) value as calculated.

13. A method according to claim 12, further comprising:

setting an oxygen delivery threshold (DO2i_crit) value;

comparing the calculated oxygen delivery (DO2i) value with the oxygen delivery threshold (DO2i_crit) value; and

triggering a warning signal whenever the calculated oxygen delivery (DO2i) value falls below the set oxygen delivery threshold (DO2i_crit) value.

14. A method according to claim 13, wherein the warning signal is not triggered when the calculated oxygen delivery (DO2i) value falls below the set oxygen delivery threshold (DO2i_crit) value for a period of time shorter than a preset time period.

15. A method according to claim 12, wherein the method further comprises the continuous detection and display of the patient'"'"'s temperature (T).

16. A method according to claim 13, wherein the method comprises calculating the oxygen delivery threshold (DO2i_crit) value from the detected body temperature (T).

17. A method of monitoring a patient'"'"'s parameters during a cardiac operation with cardiopulmonary bypass and a heart-lung machine, the method comprising:

continuously detecting the exhaled carbon dioxide (eCO2) from the oxygenator of the heart-lung machine;

setting a gas flow (Ve) value of the heart-lung machine;

computing the carbon dioxide production (VCO2i) of the patient from the detected values of exhaled carbon dioxide (eCO2) and set values of gas flow (Ve); and

displaying the calculated carbon dioxide production (VCO2i) value.

18. A method according to claim 17, further comprising:

setting a carbon dioxide production threshold (VCO2i_crit) value;

comparing the calculated carbon dioxide production (VCO2i) value with the set carbon dioxide production threshold (VCO2i_crit) value; and

triggering a warning signal whenever the calculated carbon dioxide production (VCO2i) value exceeds the set carbon dioxide production threshold (VCO2i_crit) value.