Monitoring system for cardiac surgical operations with cardiopulmonary bypass

• US 7,931,601 B2
• Filed: 10/13/2008
• Issued: 04/26/2011
• 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): Marmor, II; Charles A
• Assistant Examiner(s): Natnithithadha; Navin
• Application Number:
  US12/250,221
• Publication Number:
  US 20090043219A1
• Time in Patent Office: 925 Days
• Field of Search: 600523-543, 600/484, 128/204.21, 128/204.22, 128/204.23, 128/204.26
• US Class Current: 600/532
• 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 method of monitoring a patient'"'"'s parameters during a cardiac operation with cardiopulmonary bypass and a heart-lung machine including a processor, the heart-lung machine operably connected to an oxygenator configured for oxygenating blood, the method comprising:

continuously detecting carbon dioxide exiting (eCO2) the oxygenator;

setting a gas flow (Ve) value of the heart-lung machine via an input device;

using the processor to calculate a computing the carbon dioxide production (VCO2i) value of the patient from the eCO2 values and set values of gas flow (Ve); and

displaying the calculated carbon dioxide production (VCO2i) value on a display.

2. A method according to claim 1, 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.

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

detecting carbon dioxide exiting (eCO2) from an oxygenator of the heart-lung machine;

setting a gas flow (Ve) value of the heart-lung machine via an input device;

using the processor to calculate a carbon dioxide production (VCO2i) value of the patient from the eCO2 values and set values of gas flow (Ve); and

displaying the calculated carbon dioxide production (VCO2i) value on a display.

4. A method according to claim 3, 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 value (VCO2i_crit) value.

5. A method of monitoring a patient'"'"'s parameters during a cardiac operation with cardiopulmonary bypass and a heart-lung machine including a processor, the heart-lung machine operably connected to an oxygenator configured for oxygenating blood, the method comprising:

using a CO2 detector to detect CO2 exiting the oxygenator and provide an exiting carbon dioxide (eCO2) value;

setting a gas flow (Ve) value of the heart-lung machine via an input device;

using the processor to calculate a carbon dioxide production (VCO2i) value of the patient from the eCO2 values and set values of gas flow (Ve);

displaying the calculated carbon dioxide production (VCO2i) value on a display;

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.