Integrated cardiopulmonary bypass system for open and closed bypass circuits

• US 7,458,952 B2
• Filed: 11/14/2005
• Issued: 12/02/2008
• Est. Priority Date: 11/18/2004
• Status: Expired due to Fees

• Current Assignee: Medici Life Sciences Licensing Company LLC (The Medici Portfolio LLC)
• Original Assignee: Venkataramana Vijay
• Inventors: Vijay, Venkataramana
• Primary Examiner(s): Deak; Leslie
• Assistant Examiner(s): WIEST, PHILIP R
• Application Number:
  US11/273,626
• Publication Number:
  US 20060155237A1
• Time in Patent Office: 1,114 Days
• Field of Search: 604/4.01, 604/6.07, 604/6.09, 604/7, 604/5.01, 604/6.01, 604 61- 614, 604/6.16, 604/65, 604/67, 604/73, 604/122, 604/405, 604/406, 422 44- 48, 210/305, 210/335, 210/446, 210/90, 210/97, 210/98, 210/103, 210/104, 261/24, 261 26- 30, 261 82- 87, 261/110
• US Class Current: 604/6.1
• 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 1/3623 Means for actively controlling temperature of blood
• 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 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 60/851 Valves
• CPC Class Codes: A61M 60/892 Active valves, i.e. actuated by an external force
• CPC Class Codes: A61M 60/894 Passive valves, i.e. valves actuated by the blood

Abstract

A completely integrated cardiopulmonary bypass system includes a common casing provided with a reservoir, a venous air trap, oxygenator, heat-exchanger and a pump. This totally integrated system provides for volume sequestration and for bypassing the reservoir without use of a shunt. The system also provides for open or closed circuit operation, thereby permitting the volume sequestration. The closed circuit operation has a venous air trap for air removal, thus retaining the safety features of both open reservoir and closed-venous air trap systems.

Claims

1. A cardiopulmonary bypass system for connection to a venous-side blood source and an arterial-side blood return, comprising:

a reservoir having an inlet in fluid communication with the venous-side blood source, and an outlet with a manually operable valve enabling a perfusionist to control the valve and sequester blood in the reservoir from a remainder of the bypass system;

a venous air trap having an inlet in fluid communication with the venous-side blood source and an outlet, the venous air trap for removing air entrained within blood from the venous-side blood source passing through the air trap;

a pump for moving blood from the reservoir toward the arterial side blood return, the pump having an inlet in fluid communication with the outlets of the reservoir and the venous air trap;

an oxygenator for oxygenating blood from the a venous-side blood source; and

a heat-exchanger through which the blood is transferred,

the reservoir, the air trap, the pump, the heat exchanger and the oxygenator all provided in a common housing,

wherein the inlet of the reservoir defines a ‘

Y’

connector having a first end communicating with the venous-side blood source and a second branched end, a first branch of the branched end communicating with the reservoir, and a second branch of the branched end communicating with the inlet of the air trap, and

at of each of the inlet and outlet to the reservoir is provided a three-way valve,

the valve at the inlet of the reservoir directing blood flow when (i) in a first position into the reservoir, (ii) in a second position into the air trap, and (iii) in a third position, to both the reservoir and air trap, and

the valve at the outlet of the reservoir permitting blood flow when (i) in a first position from the reservoir, (ii) in a second position from the air trap, and (iii) in a third position, from both the reservoir and air trap.

2. A bypass system according to claim 1, wherein:

the reservoir substantially surrounds the air trap, the pump, the heat exchanger and the oxygenator.

3. A bypass system according to claim 1, wherein:

the air trap is substantially completely located within the reservoir.

4. A bypass system according to claim 1, wherein:

the air trap causes the direction of the flow of blood to reverse.

5. A bypass system according to claim 4, wherein:

the air trap includes two 180°

changes in direction in the flow of blood.

6. A bypass system according to claim 1, further comprising:

an active air removal system coupled to said air trap.

7. A cardiopulmonary bypass system for connection to a venous-side blood source and an arterial-side blood return, comprising:

a reservoir for storing blood, the reservoir having an inlet in fluid communication with the venous-side blood source, and an outlet with a manually operable valve enabling a perfusionist to control the valve and sequester blood in the reservoir from a remainder of the bypass system;

a venous air trap having an inlet in fluid communication with the venous-side blood source and an outlet, the venous air trap for removing air entrained within blood from the venous-side blood source passing through the air trap;

a pump for moving blood from the reservoir toward the arterial side blood return, the pump having an inlet in fluid communication with the outlets of the reservoir and the venous air trap;

an oxygenator for oxygenating blood from the venous-side blood source;

a heat-exchanger through which the blood is transferred;

a first three-way valve is provided communicating the inlet of the venous-side blood source, the inlet of the reservoir, and the inlet of the air trap, and;

a second three-way valve is provided communicating the outlet of the reservoir, the outlet of the air trap, and the inlet of the pump, wherein

the first valve directs blood flow when (i) in a first position into the reservoir, (ii) in a second position into the air trap, and (iii) in a third position, to both the reservoir and air trap, and

the second valve permits blood flow when (i) in a first position from the reservoir, (ii) in a second position from the air trap, and (iii) in a third position, from both the reservoir and air trap.

8. A bypass system according to claim 7, further comprising:

an active air removal system coupled to said air trap.

9. A cardiopulmonary bypass system for connection to a venous-side blood source and an arterial-side blood return, comprising:

a reservoir for storing blood, the reservoir having an inlet in fluid communication with the venous-side blood source, and an outlet with a manually operable valve enabling a perfusionist to control the valve and sequester blood in the reservoir from a remainder of the bypass system;

a pump for moving blood from the reservoir toward the arterial side blood return, the pump having an inlet in fluid communication with the outlet of the reservoir;

a shunt extending through the reservoir and in fluid communication between the venous-side blood source and the pump such that the reservoir can be bypassed;

an oxygenator for oxygenating blood from the venous-side blood source; and

a heat-exchanger through which the blood is transferred.

10. A bypass system according to claim 9, wherein:

said reservoir is a constructed of a collapsible material.

11. A bypass system according to claim 9, wherein:

said reservoir is a constructed of a rigid material.