Extracorporeal blood circuit air removal system and method

• US 7,204,958 B2
• Filed: 12/22/2003
• Issued: 04/17/2007
• 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., Shorey, Frederick A., Carpenter, Walter L., Yonce, Laura A., Olsen, Robert W., Dickey, John B.
• Primary Examiner(s): Zalukaeva; Tatyana
• Assistant Examiner(s): Deak; Leslie R.
• Application Number:
  US10/743,598
• Publication Number:
  US 20040217054A1
• Time in Patent Office: 1,212 Days
• Field of Search: 604/4.01, 604/5.01, 604/6.11, 604/6.14, 604/6.16, 604/7, 210/645, 422/44, 422/45, 96/10, 261/DIG.28
• US Class Current: 422/44
• CPC Class Codes: A61M 1/32 Oxygenators without membranes
• CPC Class Codes: A61M 1/3603 in the same direction
• 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 1/3664 for preparing cardioplegia solutions
• 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 1/367 Circuit parts not covered by the preceding subgroups of group A61M1/3621
• 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 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 air removal device of an extracorporeal blood circuit providing extracorporeal oxygenation of a patient'"'"'s blood by drawing venous blood from the venous system of a patient through a venous return line and delivering oxygenated blood through an arterial line to the arterial system of the patient during cardiopulmonary bypass surgery adapted to be performed on the patient in the presence of a perfusionist, the air removal device comprising:

an air removal device housing enclosing a lower blood chamber and an upper blood inlet chamber;

an upper blood inlet through the air removal device housing to the upper blood inlet chamber that is sized and shaped to be coupled to the return line;

a lower blood outlet through the air removal device housing to the lower blood chamber that is sized and shaped to be coupled to a blood pump to draw blood into the upper blood inlet chamber and out of the lower blood chamber;

a purge port through the air removal device housing to the upper blood inlet chamber;

an upper air sensor comprising first and second piezoelectric elements at respective first and second locations of the air removal device housing having a portion of the upper blood inlet chamber between the first and second locations, the first and second locations being separated by a first distance;

a lower air sensor comprising third and fourth piezoelectric elements at respective third and fourth locations of the air removal device housing that are below the first and second piezoelectric elements, the third and fourth locations being separated by a second distance; and

wherein the first distance is different than the second distance.

2. The air removal device of claim 1, wherein the first, second, third and fourth piezoelectric elements are adhered into first, second, third and fourth slots.

3. The air removal device of claim 2, wherein:

the first and third piezoelectric elements are adapted to be coupled to an excitation source for applying element excitation signals to cause the first and third piezoelectric elements to emit acoustic energy; and

the second and fourth piezoelectric elements are adapted to be coupled to signal processing circuitry for processing electrical signals generated in the second and fourth piezoelectric elements in response to acoustic energy emitted by the respective first and third piezoelectric elements and transmitted through any blood or air therebetween.

4. The air removal device of claim 2, wherein:

the first, second, third, and fourth piezoelectric elements are each rectangular having an element length, an element width shorter than the element length, and an element thickness;

the first piezoelectric element is mounted to the air removal device housing at the first location with the element length extending in a first direction;

the second piezoelectric element is mounted to the air removal device housing at the second location with the element length extending in a second direction substantially orthogonal to the first direction;

the third piezoelectric element is mounted to the air removal device housing at the third location with the element length extending in a third direction; and

the fourth piezoelectric element is mounted to the air removal device housing at the third location with the element length extending in a second direction substantially orthogonal to the fourth direction.

5. The air removal device of claim 2, wherein:

the first, second, third, and fourth piezoelectric elements comprise piezoelectric crystal layers having opposed major surfaces bearing conductive electrodes;

an electrical conductor is connected with each conductive electrode; and

the first, second, third, and fourth piezoelectric elements are mounted into a slot of the air removal device housing with a conductive electrode disposed toward an exterior surface of the air removal device housing at the respective first, second, third and fourth locations.

6. The air removal device of claim 2, wherein:

the air removal device housing has a substantially cylindrical outer housing wall extending between opposed end walls and enclosing a substantially cylindrical cavity, a substantially tubular volume displacer extends substantially axially into the cylindrical cavity from an end wall to define and reduce the volume of the upper blood inlet chamber and the lower blood chamber;

the first and third piezoelectric elements are mounted to the volume displacer at the respective first and third locations; and

the second and third piezoelectric elements are mounted to cylindrical outer housing wall at the respective second and fourth locations.

7. The air removal device of claim 1, wherein:

the first and third piezoelectric elements are adapted to be coupled to an excitation source for applying element excitation signals to cause the first and third piezoelectric elements to emit acoustic energy; and

the second and fourth piezoelectric elements are adapted to be coupled to signal processing circuitry for processing electrical signals generated in the second and fourth piezoelectric elements in response to acoustic energy emitted by the respective first and third piezoelectric elements and transmitted through any blood or air therebetween.

8. The air removal device of claim 1, wherein:

the first, second, third, and fourth piezoelectric elements are each rectangular having an element length, an element width shorter than the element length, and an element thickness;

the first piezoelectric element is mounted to the air removal device housing at the first location with the element length extending in a first direction;

the second piezoelectric element is mounted to the air removal device housing at the second location with the element length extending in a second direction substantially orthogonal to the first direction;

the third piezoelectric element is mounted to the air removal device housing at the third location with the element length extending in a third direction; and

the fourth piezoelectric element is mounted to the air removal device housing at the third location with the element length extending in a second direction substantially orthogonal to the fourth direction.

9. The air removal device of claim 1, wherein:

the first, second, third, and fourth piezoelectric elements comprise piezoelectric crystal layers having opposed major surfaces bearing conductive electrodes;

an electrical conductor is connected with each conductive electrode; and

the first, second, third, and fourth piezoelectric elements are mounted into the air removal device housing slot with a conductive electrode disposed toward an exterior surface of the air removal device housing at the respective first, second, third and fourth locations.

10. The air removal device of claim 9, wherein the electrical conductors extend to connector elements of an air removal device connector adapted to coupled to a cable connector of an air removal device cable, the air removal device connector having a further pair of connector elements coupled together to enable a continuity check to be performed through a pair of conductors of the air removal device cable when the cable connector is properly connected to the air removal device cable.

11. The air removal device of claim 1, wherein:

the air removal device housing has a substantially cylindrical outer housing wall extending between opposed end walls and enclosing a substantially cylindrical cavity, a substantially tubular volume displacer extends substantially axially into the cylindrical cavity from an end wall to define and reduce the volume of the upper blood inlet chamber and the lower blood chamber;

the first and third piezoelectric elements are mounted to the volume displacer at the respective first and third locations; and

the second and fourth piezoelectric elements are mounted to the cylindrical outer housing wall at the respective second and fourth locations.