Extracorporeal blood circuit priming system and method

• US 7,682,563 B2
• Filed: 02/14/2007
• Issued: 03/23/2010
• Est. Priority Date: 01/14/2003
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Jones, Bruce R., Shorey, Frederick A. Jr., Bearss, Mark G., Carpenter, Walter L., Yonce, Laura A., Olsen, Robert W.
• Primary Examiner(s): Deak; Leslie R
• Application Number:
  US11/706,005
• Publication Number:
  US 20070148036A1
• Time in Patent Office: 1,133 Days
• Field of Search: 422/45, 604/4.01, 604/5.01, 604/6.09, 210/645
• US Class Current: 422/45
• 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 1/3646 Expelling the residual body fluid after use, e.g. back to the body
• 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 2205/505 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 priming an integrated extracorporeal blood circuit with prime solution displacing air in the components and lines interconnecting the components of the extracorporeal blood circuit, the integrated extracorporeal blood circuit 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 priming method comprising:

coupling the venous return line to the arterial line;

supporting the extracorporeal blood circuit in 3-D space so that the components and lines interconnecting the components are disposed between a circuit high elevation and a circuit low elevation;

supporting a prime solution source at a source elevation higher than the circuit low elevation;

delivering prime solution into the integrated extracorporeal blood circuit at the circuit low elevation;

controlling the flow of prime solution from the prime solution source into the extracorporeal blood circuit to upward fill the components and lines of the extracorporeal blood circuit with prime solution; and

purging air from the extracorporeal blood circuit as the prime solution rises and fills the extracorporeal blood circuit.

2. A priming system employed to prime an integrated extracorporeal blood circuit with prime solution displacing air in the components and lines interconnecting the components of the extracorporeal blood circuit, the integrated extracorporeal blood circuit 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 priming system comprising:

a pre-bypass loop coupled to venous return line and arterial line connectors effecting coupling the venous return line to the arterial line;

a circuit holder having a vertical mast adapted to extend vertically adjacent to the patient to a hanger and a support arm assembly extending laterally from the vertical mast engaging and supporting the integrated extracorporeal blood circuit in 3-D space so that the components and lines interconnecting the components are disposed between a circuit high elevation and a circuit low elevation, the hanger adapted to support a prime solution source at a source elevation higher than the circuit low elevation;

a prime line adapted to be coupled to the prime solution source and extending to the circuit low elevation;

means for controlling the flow of prime solution from the prime solution source through the prime line into the extracorporeal blood circuit to upward fill the components and lines of the extracorporeal blood circuit with prime solution; and

a purge port of the extracorporeal blood circuit adapted to be opened to purge air from the extracorporeal blood circuit as the prime solution fills the extracorporeal blood circuit.

3. The priming system of claim 2 wherein the integrated extracorporeal blood circuit components comprise:

a disposable blood pump having a blood pump inlet and a blood pump outlet and adapted to be operated to draw venous blood into the blood pump inlet and pump the venous blood out of the blood pump outlet;

a disposable venous air removal device (VARD) having an upper venous blood inlet coupled to the venous return line and a lower venous blood outlet coupled to the blood pump inlet, whereby venous blood is drawn through the VARD by operation of the blood pump;

a disposable blood oxygenator having an oxygenator venous blood inlet coupled to the blood pump outlet and an oxygenated blood outlet, the blood oxygenator adapted to be operated to oxygenate venous blood pumped by the blood pump into the oxygenator venous blood inlet; and

a disposable arterial filter having an arterial filter inlet coupled to the oxygenated blood outlet of the blood oxygenator and an arterial filter outlet coupled to the arterial line.