Active air removal system operating modes of an extracorporeal blood circuit

• US 7,201,870 B2
• Filed: 12/22/2003
• Issued: 04/10/2007
• Est. Priority Date: 01/14/2003
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Stringham, Mark D., Carpenter, Walter L., Olsen, Robert W., Dickey, John B.
• Primary Examiner(s): Zalukaeva; Tatyana
• Assistant Examiner(s): DEAK, LESLIE R
• Application Number:
  US10/743,116
• Publication Number:
  US 20040197223A1
• Time in Patent Office: 1,205 Days
• Field of Search: 604 401- 501, 604/6.09, 604/6.1, 604/6.11, 604 614- 616, 604/7, 604 65- 67, 604/27, 604/30, 604/80, 604/264, 604/45, 422 44- 45, 210/645, 210/416.1, 210/500.21, 210/739, 210/746, 248/689, 248/122.1, 248/674, 248/676, 261/DIG.28
• US Class Current: 422/44
• CPC Class Codes: A61M 1/3606 Arrangements for blood-volume reduction of extra-corporeal circuits
• CPC Class Codes: A61M 1/3623 Means for actively controlling temperature of blood
• CPC Class Codes: A61M 1/3626 Gas bubble detectors
• CPC Class Codes: A61M 1/3627 Degassing devices; Buffer reservoirs; Drip chambers; Blood filters
• CPC Class Codes: A61M 1/3643 Priming, rinsing before or after use
• CPC Class Codes: A61M 1/3644 Mode of operation
• CPC Class Codes: A61M 1/3666 Cardiac or cardiopulmonary bypass, e.g. heart-lung machines
• CPC Class Codes: A61M 1/3667 with assisted venous return
• CPC Class Codes: A61M 2205/50 with microprocessors or computers
• CPC Class Codes: A61M 2205/502 User interfaces, e.g. screens or keyboards
• CPC Class Codes: A61M 2205/505 Touch-screens; Virtual keyboard or keypads; Virtual buttons; Soft keys; Mouse touches
• CPC Class Codes: A61M 2209/082 Mounting brackets, arm supports for equipment
• CPC Class Codes: Y10S 261/28 Blood oxygenators

Abstract

A disposable, integrated extracorporeal blood circuit employed during cardiopulmonary bypass surgery performs gas exchange, heat transfer, and microemboli filtering functions in a way as to conserve volume, to reduce setup and change out times, to eliminate a venous blood reservoir, and to substantially reduce blood-air interface. Blood from the patient or prime solution is routed through an air removal device that is equipped with air sensors for detection of air. An active air removal controller removes detected air from blood in the air removal device. A disposable circuit support module is used to mount the components of the disposable, integrated extracorporeal blood circuit in close proximity and in a desirable spatial relationship to optimize priming and use of the disposable, integrated extracorporeal blood circuit. A reusable circuit holder supports the disposable circuit support module in relation to a prime solution source, the active air removal controller and other components.

Claims

1. A method of operating an active air removal (AAR) system to purge air from an integrated extracorporeal blood circuit providing extracorporeal oxygenation of a patient'"'"'s blood during cardiopulmonary bypass surgery adapted to be performed in the presence of a perfusionist on a patient in an operating room, the operating method comprising:

providing an air removal device incorporated in the extracorporeal blood circuit, the air removal device comprising;

an air removal device housing enclosing a chamber;

an air removal device purge port through the housing to the chamber;

an air sensor supported by the air removal device housing adapted to provide an air sensor signal indicative of air in the air removal device housing;

an air removal device purge line coupled to the air removal device purge port and extending to a purge line connector adapted to be coupled to a vacuum source to apply suction to the air removal device purge port to draw air therefrom;

providing an AAR controller operating under the control of an AAR operating algorithm;

locating a portion of the air removal purge line extending through a purge valve of the AAR controller, the purge valve movable between a purge valve open position and a purge valve closed position;

coupling the air sensor with the AAR controller;

commencing the AAR controller operating algorithm that;

enters a self-test mode that performs specified self-tests of components and operating conditions of the AAR controller;

progresses to a standby mode when self-tests are completed to monitor specified components and operating conditions of the AAR controller, to power the air sensor, and to monitor the air sensor signal; and

responds to a perfusionist initiated command to enter an automatic mode from the standby mode enabling automatic movement of the purge valve from the closed position to the open position when the air sensor signal is indicative of air in the air removal device housing to allow air sensed in the air removal device to be purged through the purge line by the suction of the vacuum source;

wherein the AAR controller operating system is powered by a power supply adapted to be coupled to mains power or by a backup battery, and wherein a power state self-test is performed in the self-test mode comprising;

determining if the power supply is operative and capable of supplying operating power to the AAR controller operating system;

determining if the backup battery is present and capable of supplying operating power to the AAR controller operating system;

supplying operating power from the backup battery to the AAR controller operating system when the power supply is determined to be inoperative or incapable of supplying operating power to the AAR controller operating system and the backup battery is determined to be present and capable of supplying operating power to the AAR controller operating system; and

further comprising inhibiting the automatic movement of the purge valve from the closed position to the open position in the automatic mode when the air sensor signal is indicative of air in the air removal device housing if the power supply is determined to be inoperative or incapable of supplying operating power to the AAR controller operating system.

2. The operating method of claim 1, wherein the AAR controller further comprises a mechanical release button interconnected with the purge valve adapted to enable manual opening of the purge valve by the perfusionist in the standby and the automatic modes.

3. The operating method of claim 1, further comprising:

determining an error state of the purging system; and

alerting the perfusionist of the error state.

4. The purging method of claim 3, wherein the alerting step comprises:

formulating alert message signals related to the determined error state; and

displaying alert messages readable by the perfusionist on a display screen.

5. The purging method of claim 3, wherein the alerting step comprises:

formulating alert sound signals related to the determined error state; and

applying the formulated alert sound signals to a sound emitter that emits audible alert sounds that can be heard by the perfusionist.

6. The purging method of claim 3, wherein the alerting step comprises:

formulating alert light signals related to the determined error state; and

applying the formulated alert light signals to at least one light emitter that emits visual light in response to the alert light signals that can be seen by the perfusionist.

7. A method of operating an active air removal (AAR) system to purge air from an integrated extracorporeal blood circuit providing extracorporeal oxygenation of a patient'"'"'s blood during cardiopulmonary bypass surgery adapted to be performed in the presence of a perfusionist on a patient in an operating room, the operating method comprising:

providing an air removal device incorporated in the extracorporeal blood circuit, the air removal device comprising;

an air removal device housing enclosing a chamber;

an air removal device purge port through the housing to the chamber;

an air sensor supported by the air removal device housing adapted to provide an air sensor signal indicative of air in the air removal device housing;

an air removal device purge line coupled to the air removal device purge port and extending to a purge line connector adapted to be coupled to a vacuum source to apply suction to the air removal device purge port to draw air therefrom;

providing an AAR controller operating under the control of an AAR operating algorithm;

locating a portion of the air removal purge line extending through a purge valve of the AAR controller, the purge valve movable between a purge valve open position and a purge valve closed position;

coupling the air sensor with the AAR controller;

commencing the AAR controller operating algorithm that;

enters a self-test mode that performs specified self-tests of components and operating conditions of the AAR controller;

progresses to a standby mode when self-tests are completed to monitor specified components and operating conditions of the AAR controller, to power the air sensor, and to monitor the air sensor signal; and

responds to a perfusionist initiated command to enter an automatic mode from the standby mode enabling automatic movement of the purge valve from the closed position to the open position when the air sensor signal is indicative of air in the air removal device housing to allow air sensed in the air removal device to be purged through the purge line by the suction of the vacuum source;

determining an error state of the purging system; and

inhibiting the automatic movement of the purge valve from the closed position to the open position in the automatic mode when an error state is detected;

wherein the error determining step comprises determining the presence of fluid in the purge line;

wherein the AAR controller further comprises a fluid in line (FIL) sensor arranged with respect to the purge valve, and further comprising;

locating a further portion of the purge line through the FIL sensor; and

powering the FIL sensor to develop a FIL sensor signal indicative of the absence or presence of fluid in the purge line, and wherein;

the error determining step comprises determining the presence of fluid in the purge line from the FIL sensor signal; and

wherein the AAR controller further comprises a mechanical release button interconnected with the purge valve adapted to enable manual opening of the purge valve by the perfusionist.

8. A method of operating an active air removal (AAR) system to purge air from an integrated extracorporeal blood circuit providing extracorporeal oxygenation of a patient'"'"'s blood during cardiopulmonary bypass surgery adapted to be performed in the presence of a perfusionist on a patient in an operating room, the operating method comprising:

providing an air removal device incorporated in the extracorporeal blood circuit, the air removal device comprising;

an air removal device housing enclosing a chamber;

an air removal device purge port through the housing to the chamber;

an air sensor supported by the air removal device housing adapted to provide an air sensor signal indicative of air in the air removal device housing;

an air removal device purge line coupled to the air removal device purge port and extending to a purge line connector adapted to be coupled to a vacuum source to apply suction to the air removal device purge port to draw air therefrom;

providing an AAR controller operating under the control of an AAR operating algorithm;

locating a portion of the air removal purge line extending through a purge valve of the AAR controller, the purge valve movable between a purge valve open position and a purge valve closed position;

coupling the air sensor with the AAR controller;

commencing the AAR controller operating algorithm that;

enters a self-test mode that performs specified self-tests of components and operating conditions of the AAR controller;

progresses to a standby mode when self-tests are completed to monitor specified components and operating conditions of the AAR controller, to power the air sensor, and to monitor the air sensor signal; and

responds to a perfusionist initiated command to enter an automatic mode from the standby mode enabling automatic movement of the purge valve from the closed position to the open position when the air sensor signal is indicative of air in the air removal device housing to allow air sensed in the air removal device to be purged through the purge line by the suction of the vacuum source;

wherein the error determining step comprises determining an error state of the air sensor; and

further comprising;

connecting an air sensor cable between the AAR controller and the air sensor; and

wherein the error determining step determines if electrical continuity is present in the connection of the air sensor cable between the AAR controller and the air sensor.

9. A method of operating an active air removal (AAR) system to purge air from an integrated extracorporeal blood circuit providing extracorporeal oxygenation of a patient'"'"'s blood during cardiopulmonary bypass surgery adapted to be performed in the presence of a perfusionist on a patient in an operating room, the operating method comprising:

providing an air removal device incorporated in the extracorporeal blood circuit, the air removal device comprising;

an air removal device housing enclosing a chamber;

an air removal device purge port through the housing to the chamber;

an air sensor supported by the air removal device housing adapted to provide an air sensor signal indicative of air in the air removal device housing;

an air removal device purge line coupled to the air removal device purge port and extending to a purge line connector adapted to be coupled to a vacuum source to apply suction to the air removal device purge port to draw air therefrom;

providing an AAR controller operating under the control of an AAR operating algorithm;

locating a portion of the air removal purge line extending through a purge valve of the AAR controller, the purge valve movable between a purge valve open position and a purge valve closed position;

coupling the air sensor with the AAR controller;

commencing the AAR controller operating algorithm that;

enters a self-test mode that performs specified self-tests of components and operating conditions of the AAR controller;

progresses to a standby mode when self-tests are completed to monitor specified components and operating conditions of the AAR controller, to power the air sensor, and to monitor the air sensor signal; and

responds to a perfusionist initiated command to enter an automatic mode from the standby mode enabling automatic movement of the purge valve from the closed position to the open position when the air sensor signal is indicative of air in the air removal device housing to allow air sensed in the air removal device to be purged through the purge line by the suction of the vacuum source;

determining an error state of the purging system;

inhibiting the automatic movement of the purge valve from the closed position to the open position in the automatic mode when an error state is detected; and

wherein the error determining step comprises determining a low vacuum condition.

10. The operating method of claim 9, wherein:

the AAR controller further comprises a vacuum sensor arranged with respect to the purge line to provide a vacuum signal indicative of vacuum in the purge line;

the error determining step determines a low vacuum error state if the sensed vacuum falls below a minimum vacuum.

11. A method of operating an active air removal (AAR) system to purge air from an integrated extracorporeal blood circuit providing extracorporeal oxygenation of a patient'"'"'s blood during cardiopulmonary bypass surgery adapted to be performed in the presence of a perfusionist on a patient in an operating room, the operating method comprising:

providing an air removal device incorporated in the extracorporeal blood circuit, the air removal device comprising;

an air removal device housing enclosing a chamber;

an air removal device purge port through the housing to the chamber;

an air sensor supported by the air removal device housing adapted to provide an air sensor signal indicative of air in the air removal device housing;

an air removal device purge line coupled to the air removal device purge port and extending to a purge line connector adapted to be coupled to a vacuum source to apply suction to the air removal device purge port to draw air therefrom;

providing an AAR controller operating under the control of an AAR operating algorithm;

locating a portion of the air removal purge line extending through a purge valve of the AAR controller, the purge valve movable between a purge valve open position and a purge valve closed position;

coupling the air sensor with the AAR controller;

commencing the AAR controller operating algorithm that;

enters a self-test mode that performs specified self-tests of components and operating conditions of the AAR controller;

progresses to a standby mode when self-tests are completed to monitor specified components and operating conditions of the AAR controller, to power the air sensor, and to monitor the air sensor signal; and

responds to a perfusionist initiated command to enter an automatic mode from the standby mode enabling automatic movement of the purge valve from the closed position to the open position when the air sensor signal is indicative of air in the air removal device housing to allow air sensed in the air removal device to be purged through the purge line by the suction of the vacuum source;

determining an error state of the purging system;

inhibiting the automatic movement of the purge valve from the closed position to the open position in the automatic mode when an error state is detected; and

wherein the error determining step comprises determining a purge valve error state of the purge valve.

12. The operating method of claim 11, wherein the purge valve error state determining step comprises:

commanding the purge valve to move into one of the purge valve open and closed positions;

sensing the purge valve position and providing a purge valve position signal indicative of the actual position of the purge valve; and

determining a position error state of the purge valve or the purge valve operating means when the sensed purge valve position signal does not confirm that the purge valve is in the commanded purge valve open position or purge valve closed position.

13. The operating method of claim 11, wherein:

the purge valve comprises a pinch valve having a valve slot receiving the portion of the purge line and a pinch rod adapted to be moved between a purge valve closed position extending into the slot to compress the purge line and a purge valve open position retracted out of the slot; and

the purge valve opening step comprises moving the pinch rod from the purge valve closed position to the purge valve open position.

14. The operating method of claim 13, further comprising:

determining a pinch valve error state of the pinch valve; and

inhibiting the automatic movement of the pinch valve from the closed position to the open position in the automatic mode when a pinch valve error state is detected.

15. The operating method of claim 14, wherein the pinch valve error state determining step comprises:

commanding the pinch rod to move into one of the purge valve open and closed positions;

sensing the pinch rod position and providing a pinch rod position signal indicative of the actual position of the pinch rod; and

determining a position error state of the pinch valve when the pinch rod position signal does not confirm that the pinch rod is in the commanded purge valve open or purge valve closed position.

16. A method of operating an active air removal (AAR) system to purge air from an integrated extracorporeal blood circuit providing extracorporeal oxygenation of a patient'"'"'s blood during cardiopulmonary bypass surgery adapted to be performed in the presence of a perfusionist on a patient in an operating room, the operating method comprising:

providing an air removal device incorporated in the extracorporeal blood circuit, the air removal device comprising;

an air removal device housing enclosing a chamber;

an air removal device purge port through the housing to the chamber;

an air sensor supported by the air removal device housing adapted to provide an air sensor signal indicative of air in the air removal device housing;

an air removal device purge line coupled to the air removal device purge port and extending to a purge line connector adapted to be coupled to a vacuum source to apply suction to the air removal device purge port to draw air therefrom;

providing an AAR controller operating under the control of an AAR operating algorithm;

locating a portion of the air removal purge line extending through a purge valve of the AAR controller, the purge valve movable between a purge valve open position and a purge valve closed position;

coupling the air sensor with the AAR controller;

commencing the AAR controller operating algorithm that;

enters a self-test mode that performs specified self-tests of components and operating conditions of the AAR controller;

progresses to a standby mode when self-tests are completed to monitor specified components and operating conditions of the AAR controller, to power the air sensor, and to monitor the air sensor signal; and

responds to a perfusionist initiated command to enter an automatic mode from the standby mode enabling automatic movement of the purge valve from the closed position to the open position when the air sensor signal is indicative of air in the air removal device housing to allow air sensed in the air removal device to be purged through the purge line by the suction of the vacuum source;

wherein;

the AAR controller further comprises a vacuum sensor arranged with respect to the purge line to provide a vacuum signal indicative of vacuum in the purge line when the purge valve is closed; and

determining if the sensed vacuum exceeds a minimum vacuum; and

issuing an alert if the sensed vacuum does not exceed the minimum vacuum.