Cardioplegia delivery apparatus and method of use

• US 5,702,358 A
• Filed: 02/23/1995
• Issued: 12/30/1997
• Est. Priority Date: 02/23/1995
• Status: Expired due to Term

• Current Assignee: Sorin Biomedica SpA (Snia SpA)
• Original Assignee: Sorin Biomedical, Inc. (Snia SpA)
• Inventors: Akopian, Paul, Witherspoon, Leland, Buckberg, Gerald D.
• Primary Examiner(s): Weiss, John G.
• Assistant Examiner(s): O YONG, KI
• Application Number:
  US08/393,317
• Time in Patent Office: 1,041 Days
• Field of Search: 604/4, 604/65, 604/67, 604/113, 604/151, 604/153, 128/DIG. 3, 236/18, 165/132
• US Class Current: 604/6.1
• CPC Class Codes: A61M 1/3623 Means for actively controlling temperature of blood
• CPC Class Codes: A61M 1/3664 for preparing cardioplegia solutions
• CPC Class Codes: A61M 2205/3344 Measuring or controlling pressure at the body treatment site
• CPC Class Codes: A61M 2205/3355 Controlling downstream pump pressure
• CPC Class Codes: A61M 2205/3606 cooled
• CPC Class Codes: A61M 2205/366 by liquid heat exchangers
• CPC Class Codes: Y10S 128/03 Heart-lung

Abstract

A cardioplegia delivery device for providing variable ratio delivery of blood and cardioplegia solution to a patient. The device includes separate pumps for crystalloid and blood. A heat exchanger control circuit is provided which includes a heater and an ice bath for warming or cooling the cardioplegia fluid delivered to the patient. The heat exchanger control circuit includes a priming circuit which may be used to purge air bubbles from the circuit.

Claims

1. A variable ratio delivery device for delivering blood from a blood source and cardioplegia solution from a cardioplegia solution source, the blood and cardioplegia solution being combined in a selected ratio for delivery to a patient, the device comprising:

a first pump having an inlet connected to the cardioplegia solution source to cause cardioplegia solution to flow through the first pump and having an outlet connected to a cardioplegia solution supply line;

a second pump having an inlet connected to the blood source to cause blood to flow through the second pump and having an outlet connected to a blood supply line;

a delivery line connected to receive cardioplegia solution from the cardioplegia solution supply line and blood from the blood supply line; and

a pump controller for adjusting the rate of flow of cardioplegia solution through the first pump and the rate of flow of blood through the second pump until the selected ratio of blood and cardioplegia solution is supplied to the delivery line.

2. The device of claim 1 further including a pressure sensor for sensing a pressure of the combined blood and cardioplegia solution at a site of delivery to the patient.

3. The device of claim 2 wherein the pressure sensor senses an antegrade pressure and whereto the prop controller may be programmed with a high antegrade pressure upper limit and wherein the pump controller is responsive to a sensed pressure which is above the upper limit to do at least one of adjusting the rate of flow through at least one of the first and second pumps, stopping at least one of the first and second pumps, or sounding an alarm.

4. The device of claim 2 wherein the pressure sensor senses an antegrade pressure and wherein the pump controller may be programmed with a low antegrade pressure lower limit and wherein the pump controller is responsive to a sensed pressure which is below the lower limit to do at least one of adjusting the rate of flow through at least one of the first and second pumps, stopping at least one of the first and second pumps, or sounding an alarm.

5. The device of claim 2 wherein the pressure sensor senses a retrograde pressure and wherein the pump controller may be programmed with a high retrograde pressure upper limit and wherein the pump controller is responsive to a sensed pressure which is above the upper limit to do at least one of adjusting the rate of flow through at least one of the first and second pumps, stopping at least one of the first and second pumps, or sounding an alarm.

6. The device of claim 2 wherein the pressure sensor senses a retrograde pressure and wherein the pump controller may be programmed with a low retrograde pressure lower limit and wherein the pump controller is responsive to a sensed pressure which is below the lower limit to do at least one of adjusting the rate of flow through at least one of the first and second pumps, stopping at least one of the first and second pumps, or sounding an alarm.

7. The device of claim 2 wherein the pump controller may be programmed with a desired pressure valve and wherein the pump controller is responsive to a sensed pressure to adjust the rate of flow through at least one of the first and second pumps in order to adjust the sensed pressure to the desired valve.

8. A device for delivering a selected ratio of blood from a blood source and cardioplegia solution from a cardioplegia solution source to a heat exchanger for delivery to a patient and for providing temperature controlled heat exchange liquid to circulate through a heat exchange liquid flow path of the heat exchanger for controlling the temperature of the blood and cardioplegia solution mixture provided to the patient, the device comprising:

a first pump having an inlet connected to receive cardioplegia solution from the cardioplegia source and an outlet connected to a cardioplegia solution supply line;

a second pump having an inlet connected to receive blood from the blood source and an outlet connected to a blood supply line;

a delivery line connected to receive cardioplegia solution from the cardioplegia supply line and blood from the blood supply line and to deliver a combined blood and cardioplegia solution mixture to the heat exchanger;

a pump controller for adjusting the rate of flow of the cardioplegia solution through the first prop and the rate of flow of blood through the second pump until the selected ratio of blood and cardioplegia solution is supplied to the delivery line;

a reservoir to hold cooled heat exchange liquid;

a heater having an inlet connected to receive heat exchange liquid from the reservoir and an outlet connected to a heat exchange liquid inlet of the heat exchanger;

a valve having an input connected to receive heat exchange liquid from a heat exchange liquid outlet of the heat exchanger and having a first outlet connected to the reservoir and a second outlet connected to deliver heat exchange liquid to the input of the heater, the valve being controllable such that either of such first and second outlets is selectable; and

a pump connected to move heat exchange liquid from the reservoir through the heater and heat exchanger and back to the reservoir when the first outlet of the valve is selected and to recirculate heat exchange fluid through heater and heat exchanger when the second outlet of the valve is selected.

9. A method for delivering a desired ratio of cardioplegia solution and blood to a patient comprising:

providing a source of cardioplegia solution;

providing a source of blood;

connecting the source of cardioplegia solution to an inlet of a first pump having a variable flow rate;

connecting an outlet of the first pump to a cardioplegia supply line;

connecting the source of blood to an inlet of a second pump having a variable flow rate;

connecting an outlet of the second pump to a blood supply line;

connecting a patient delivery line to receive and combine cardioplegia solution from the cardioplegia supply line and blood from the blood supply line;

adjusting the flow rates of the first and second pumps to provide the desired ratio of cardioplegia solution and blood to the patient delivery line; and

delivering the combined blood and cardioplegia solution to the patient.