Active air removal from an extracorporeal blood circuit

• US 20070258856A1
• Filed: 06/13/2007
• Published: 11/08/2007
• Est. Priority Date: 01/14/2003
• Status: Active Grant

• Current Assignee: John Dickey, Mark Stringham, Robert Olsen, Walter Carpenter
• Original Assignee: John Dickey, Mark Stringham, Robert Olsen, Walter Carpenter
• Inventors: Dickey, John, Olsen, Robert, Stringham, Mark, Carpenter, Walter
• Granted Patent: US 7,829,018 B2
• Time in Patent Office: Days
• US Class Current: 422/45
• CPC Class Codes: A61M 1/1698 Blood oxygenators with or without heat-exchangers intracorporal A61M1/1678; manufacturing of membranes therefor B01D67/00; semi-permeable membranes for separation processes characterised by their properties B01D69/00; semi-permeable membranes characterised by their material B01D71/00
• CPC Class Codes: A61M 1/32 Oxygenators without membranes
• CPC Class Codes: A61M 1/3606 Arrangements for blood-volume reduction of extra-corporeal circuits
• CPC Class Codes: A61M 1/3621 Extra-corporeal blood circuits single-needle circuits A61M1/30
• 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 1/3666 Cardiac or cardiopulmonary bypass, e.g. heart-lung machines
• CPC Class Codes: A61M 1/3667 with assisted venous return
• CPC Class Codes: A61M 2205/3379 Masses, volumes, levels of fluids in reservoirs, flow rates
• 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 2205/8206 battery-operated
• CPC Class Codes: A61M 2209/08 Supports for equipment
• CPC Class Codes: A61M 2209/082 Mounting brackets, arm supports for equipment
• CPC Class Codes: A61M 60/113 in other functional devices, e.g. dialysers or heart-lung machines
• CPC Class Codes: A61M 60/232 Centrifugal pumps
• CPC Class Codes: A61M 60/38 Blood oxygenation
• CPC Class Codes: A61M 60/849 Disposable parts
• CPC Class Codes: A61M 60/853 : the valve being formed by a flexible tube element which is clamped for restricting the flow
• CPC Class Codes: A61M 60/892 : Active valves, i.e. actuated by an external force
• 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. An active air removal (AAR) system for purging air from an integrated extracorporeal blood circuit providing extracorporeal oxygenation of a patient'"'"'s blood during cardiopulmonary bypass surgery adapted to be performed on a patient in the presence of a perfusionist, the AAR system comprising:

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; and

an air sensor supported by the air removal device housing in relation to the chamber adapted to provide an air sensor signal indicative of the presence of fluid or 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; and

an AAR controller having a purge valve adapted to receive a portion of the purge line and AAR controller circuitry to open or close the purge line, the AAR controller circuitry further comprising;

purge valve operating means for opening the purge valve in response to an air sensor signal indicative of the presence 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;

error state determining means for monitoring operations and conditions of the AAR system and determining an error state of the AAR system; and

altering means for altering the perfusionist of the error state.

3. The AAR system of claim 1, wherein:

the AAR controller further comprises a fluid in line (FIL) sensor arranged with respect to the purge valve adapted to receive a portion of the purge line to provide a FIL sensor signal to the AAR controller circuitry;

the error determining means determines if the FIL sensor signal indicates the presence of fluid in the purge line; and

the alerting means issues an alert that fluid is present in the purge line when the error determining means determines that the FIL sensor signal indicates the presence of fluid in the purge line.

4. The AAR system of claim 3, wherein the purge valve operating means is inhibited from opening the purge valve in response the air sensor signal indicative of the presence of air in the air removal device housing when the FIL sensor signal is determined to be indicative of fluid in the purge line.

8. The AAR system of claim 1, 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 operating means is coupled to the pinch rod to move the pinch rod between the purge valve closed position and the purge valve open position.

17. The AAR system of claim 1, wherein:

the AAR controller further comprises a backup battery for providing operating power to the AAR controller circuitry;

the error state determining means determines if the backup battery is providing adequate operating power; and

the alerting means issues a backup battery error alert if the backup battery is not providing adequate operating power.

18. The AAR system of claim 1, wherein:

the alerting means formulates alert message signals; and

the AAR controller further comprises a display screen that the alert messages are applied to for displaying messages readable by the perfusionist.

2. (canceled)

5-7. -7. (canceled)

9-16. -16. (canceled)

19-20. -20. (canceled)

21. 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 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; and

an air removal device purge line coupled to the air removal device purge port 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;

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

applying operating power to the air sensor to generate an air sensor signal indicative of the absence or presence of air in the air removal device housing;

opening the purge valve in response to an air sensor signal indicative of the presence 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;

monitoring operations or conditions of the AAR system;

determining an error state of the monitored operations or conditions of the AAR system; and

issuing an alert to alert the perfusionist of the error state.

28. The purging method of claim 21, 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.

36. The purging method of claim 21, wherein:

the AAR controller further comprises AAR controller circuitry and a backup battery for providing operating power to the AAR controller circuitry;

the determining step comprises determining if the backup battery is providing adequate operating power; and

the alert issuing step comprises issuing a backup battery error alert if the backup battery is not providing adequate operating power.

37. The purging method of claim 21, wherein:

the AAR controller further comprises a backup battery for providing operating power to the AAR controller circuitry;

the determining step comprises determining if the backup battery is providing adequate operating power; and

the alert issuing step comprises issuing a backup battery error alert if the backup battery is not providing adequate operating power.

38. The purging method of claim 21, wherein the alert issuing step comprises:

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

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

22-27. -27. (canceled)

29-35. -35. (canceled)

39-40. -40. (canceled)

41. 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 active air removal 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;

monitoring operations or conditions of the AAR system;

determining an error state of the monitored operations or conditions of the AAR system; and

automatically moving of the purge valve from the closed position to the open position in an absence of a determined error state and 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.

47. The operating method of claim 41, further comprising alerting the perfusionist of the determined error state.

58. The operating method of claim 41, 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.

42-46. -46. (canceled)

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59-61. -61. (canceled)