Method of blood oxygenation

• US 6,565,807 B1
• Filed: 12/21/1999
• Issued: 05/20/2003
• Est. Priority Date: 09/30/1999
• Status: Expired due to Fees

• Current Assignee: TherOx Incorporated (Asahi Kasei Corporation)
• Original Assignee: TherOx Incorporated (Asahi Kasei Corporation)
• Inventors: Patterson, William R., Divino, Vincent Jr., Myrick, Stephen E., Creech, Jeffrey L., Buhr, Mark S.
• Primary Examiner(s): Sykes, Angela D.
• Assistant Examiner(s): BIANCO, PATRICIA
• Application Number:
  US09/467,670
• Time in Patent Office: 1,246 Days
• Field of Search: 422/44-48, 604/4.01, 604/6.09, 604/6.1, 604/6.11, 604/6.14, 604/6.16, 435/283.1, 435/284.1, 435/286--28, 435/289.1, 435/297.1, 435/297.4, 210/645, 210/650, 210/252, 210/258, 210/257--, 210/348, 210/416.1, 210/418, 210/420, 210/424, 210/433.1, 210/435-36, 210/321.6, 210/322, 210/758, 137/78.1, 137/78.5, 137/81.1, 137/561.2, 137/565.01, 261/DIG.28, 261/75, 261/87, 261/100-3, 261/105-6, 261/78-- 7, 128/DIG.3
• 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 1/3613 Reperfusion, e.g. of the coronary vessels, e.g. retroperfusion
• CPC Class Codes: A61M 1/3623 Means for actively controlling temperature of blood
• CPC Class Codes: A61M 2202/0476 Oxygenated solutions
• CPC Class Codes: B01F 23/23413 using nozzles for projecting the liquid into the gas atmosphere
• CPC Class Codes: Y10S 128/03 Heart-lung
• CPC Class Codes: Y10S 261/28 Blood oxygenators

Abstract

An apparatus and method for blood oxygenation are provided. The apparatus includes a chamber having a first inlet to receive a gas-supersaturating fluid, e.g., physiologic saline; a second inlet to receive a gas, e.g., oxygen, from a gas supply; and an outlet coupled to a capillary assembly. An atomizer nozzle coupled to the first inlet creates within the chamber fine droplets of fluid into which the gas diffuses to create the gas-supersaturated fluid, which is removed via the outlet. The removed gas-supersaturated fluid mixes with blood within a liquid-to-liquid oxygenation assembly to form oxygenated blood for delivery to a patient. Alternately, the blood may be provided by the pump to a high pressure hollow fiber or other type membrane oxygenator within which oxygen diffuses across the membrane(s) and into the blood to form oxygenated blood, again for delivery to a patient or other site.

Claims

1. A method for oxygenating blood and delivering the oxygenated blood to a patient, the method comprising the acts of:

providing a blood pump assembly coupled to a supply of blood;

providing a blood oxygenation assembly coupled to the blood pump assembly, the blood oxygenation assembly receiving the blood from the blood pump assembly and oxygenating the blood, the blood oxygenation assembly comprising;

an oxygenator having a first inlet, a second inlet, and an outlet, the blood pump adapted to deliver the blood to first inlet of the oxygenator, and

a gas-fluid supply assembly comprising;

a fluid supply;

a chamber having a first inlet, a second inlet, and an outlet;

a pump coupled to receive fluid from the fluid supply and to deliver the fluid to the first inlet of the chamber;

an oxygen gas supply coupled to deliver oxygen gas to the second inlet of the chamber, the oxygen gas supply maintaining pressure within the chamber at a predetermined level; and

an atomizer nozzle coupled to the first inlet of the chamber, the atomizer nozzle creating a droplet pattern of the fluid in the oxygen gas within the chamber to diffuse the oxygen gas into the fluid to create an oxygen-supersaturated fluid, the oxygen-supersaturated fluid collecting within the chamber below the atomizer nozzle and being removable from the chamber via the outlet of the chamber, the outlet of the chamber being coupled to the second inlet of the oxygenator to deliver the oxygen-supersaturated fluid into contact with the blood to form the oxygenated blood; and

providing a delivery assembly coupled to the outlet of the oxygenator, the delivery assembly being adapted to deliver the oxygenated blood to a patient.

2. The method, as set forth in claim 1, wherein the fluid from the fluid supply comprises fluid isotonic to blood.

3. The method, as set forth in claim 2, wherein the fluid isotonic to blood comprises saline.

4. The method, as set forth in claim 1, wherein the droplet pattern comprises a cone.

5. The method, as set forth in claim 4, wherein the cone has an included angle of about 20 degrees.

6. The method, as set forth in claim 1, wherein the oxygen-supersaturated fluid has a dissolved gas content that occupies a volume of between about 0.5 and about 3.0 times the volume of the fluid from the fluid supply normalized to standard temperature and pressure.

7. A method for oxygenating blood and delivering the oxygenated blood to a patient, the method comprising the acts of:

providing a blood pump assembly coupled to a supply of blood;

providing a blood oxygenation assembly coupled to the blood pump assembly, the blood oxygenation assembly receiving the blood from the blood pump assembly and oxygenating the blood, the blood oxygenation assembly comprising;

an oxygenator having a first inlet, a second inlet, and an outlet, the blood pump adapted to deliver the blood to first inlet of the oxygenator; and

a gas-supersaturated fluid supply assembly comprising;

a fluid supply;

a chamber having a first inlet, a second inlet, a third inlet and an outlet;

a gas supply coupled to deliver gas to the first inlet of the chamber;

a piston assembly coupled to receive fluid from the fluid supply and to deliver the fluid to the second inlet and the third inlet of the chamber;

a nozzle coupled to the third inlet of the chamber, the nozzle delivering the fluid from the piston assembly to the chamber;

a first valve coupled to the outlet of the chamber, the first valve being coupled to an actuator assembly to control delivery of gas-supersaturated fluid from the chamber, the outlet of the chamber being coupled to the second inlet of the oxygenator to deliver the oxygen-supersaturated fluid into contact with the blood to form the oxygenated blood; and

a second valve coupled to the second inlet, the second valve being coupled to an actuator assembly to control dilution during the creation of gas-supersaturated fluid within the chamber; and

providing a delivery assembly coupled to the outlet of the oxygenator, the delivery assembly being adapted to deliver the oxygenated blood to a patient.

8. The method, as set forth in claim 7, wherein the gas supply maintains a pressure within the chamber at a predetermined level.

9. The method, as set forth in claim 8, wherein the predetermined level is at least 500 psi.

10. The method, as set forth in claim 7, wherein the fluid from the fluid supply comprises physiologic fluid.

11. The method, as set forth in claim 10, wherein the physiologic fluid comprises saline.

12. The method, as set forth in claim 7, wherein the piston assembly comprises a syringe having a piston, and comprising the act of:

providing a motor coupled to the piston of the syringe to pressurize fluid from the fluid supply prior to delivery of the fluid to the first inlet of the chamber.

13. The method, as set forth in claim 7, comprising the act of:

closing the second valve to facilitate atomization of the fluid through the nozzle.

14. The method, as set forth in claim 7, comprising the act of:

opening the second valve to facilitate fluid dilution.

15. The method, as set forth in claim 7, comprising the act of:

adjusting the first valve to control removal of the gas-supersaturated fluid from the chamber.

16. The method, as set forth in claim 7, comprising the act of:

providing a control assembly coupled to the actuator assembly.

17. The method, as set forth in claim 16, comprising the act of:

providing a display coupled to the control assembly.

18. The method, as set forth in claim 7, comprising the act of:

delivering the fluid to the third inlet of the chamber continuously.

19. The method, as set forth in claim 7, comprising the act of:

delivering the fluid to the third inlet of the chamber intermittently.

20. The method, as set forth in claim 7, comprising the act of:

providing a first check valve coupled between the piston assembly and the chamber to prevent fluid loss from the chamber during delivery of fluid from the fluid supply to the piston assembly.

21. The method, as set forth in claim 20, comprising the act of:

providing a second check valve coupled between the piston assembly and the fluid supply to prevent fluid flow to the fluid supply during delivery of fluid to the chamber by the piston assembly.

22. The method, as set forth in claim 20, wherein the first check valve is coupled to the nozzle to prevent fluid and gas flow from the chamber through the nozzle.

23. The method, as set forth in claim 7, wherein the actuator assembly comprises a first solenoid coupled to the first valve, a second solenoid coupled to the second valve, and a third solenoid coupled to the third valve, each respective solenoid being adapted to move its respective valve between an opened position and a closed position.

24. The method, as set forth in claim 7, wherein the chamber comprises a disposable housing coupled to a cap.

25. An extracorporeal blood oxygenation method comprising the acts of:

preparing an oxygen-supersaturated fluid within an atomizer assembly;

preparing hyperbaric blood by mixing the oxygen-supersaturated fluid and blood within a liquid-to-liquid oxygenation assembly; and

delivering the hyperbaric blood to a patient via a catheter.

26. The method, as set forth in claim 25, comprising the act of:

delivering the oxygen-supersaturated fluid via a capillary from the atomizer assembly to the liquid-to-liquid oxygenation assembly.

27. The method, as set forth in claim 26, wherein the liquid-to-liquid oxygenation assembly comprises a pressurizable chamber, and wherein the blood and oxygen-supersaturated fluid mix within the chamber.

28. The method, as set forth in claim 27, wherein the chamber is adapted to create a vortical blood flow within the chamber.

29. The method, as set forth in claim 25, wherein the atomizer assembly comprises a chamber within which the oxygen-supersaturated fluid is formed, and further comprising the act of:

maintaining the chamber at a pressure greater than about 500 p.s.i.

30. The method, as set forth in claim 29, wherein the pressure is maintained at about 600 p.s.i.

31. The method, as set forth in claim 25, comprising the acts of:

withdrawing blood from a patient; and

delivering the blood to the liquid-liquid oxygenation assembly.