Apparatus for oxygenation of liquid state dissolved oxygen-carrying formulation

• US 4,919,895 A
• Filed: 06/18/1987
• Issued: 04/24/1990
• Est. Priority Date: 09/23/1986
• Status: Expired due to Term

• Current Assignee: PFC Therapeutics, LLC
• Original Assignee: Alpha Therapeutic Corporation (Grifols SA /Grifols Family/)
• Inventors: Davis, Charles H. Jr., Groveman, George R., Crowe, Kim C., Heldebrant, Charles M.
• Primary Examiner(s): Richman, Barry S.
• Assistant Examiner(s): Kummert, Lynn M.
• Application Number:
  US07/064,344
• Time in Patent Office: 1,041 Days
• Field of Search: 422/129, 422/44, 422/45, 422/48, 422/101, 422/103, 436/176, 436/11, 436/68, 435/283, 604/26, 128/DIG. 3, 261/DIG. 28, 210/927
• US Class Current: 422/129
• CPC Class Codes: A61K 9/0026 Blood substitute; Oxygen transporting formulations; Plasma extender
• CPC Class Codes: A61M 1/32 Oxygenators without membranes
• CPC Class Codes: A61M 2202/0476 Oxygenated solutions
• CPC Class Codes: A61P 7/08 Plasma substitutes; Perfusion solutions; Dialytics or haemodialytics; Drugs for electrolytic or acid-base disorders, e.g. hypovolemic shock artificial tears A61P27/04
• CPC Class Codes: Y10S 128/03 Heart-lung
• CPC Class Codes: Y10S 261/28 Blood oxygenators
• CPC Class Codes: Y10T 436/102499 Blood gas standard or control
• CPC Class Codes: Y10T 436/2525 Stabilizing or preserving

Abstract

Perfluorocarbon emulsion formulations are oxygenated prior to use by means of a portable oxygenation system. The blood substitute is in a closed container or bag. An oxygen-containing gas is introduced into the bag from a separate container. The bag is continuously agitated for a sufficient time to increase the pO₂ of the perfluorocarbon emulsion formulations to a desired pressure, e.g., to at least 600 mmHg. In one embodiment, the system used for oxygenation of the perfluorocarbon emulsion formulations comprises a small tank for gas having an inlet port and an outlet port fitted with shut-off valves. The outlet port is adapted to be connected to a filter which, in turn, is adapted to be connected to the inlet port of a three-way valve. The primary outlet of the three-way valve is adapted to mount a hypodermic needle which is adapted to be pushed through a rubber septum in a port of the bag to communicate with the interior of the bag. The tank is adapted to be filled with oxygen-containing gas, such as carbogen, from a main gas source under pressure. The tank, filter, three-way valve and needle arrangement are connected in series, and the oxygen-containing gas is permitted to flow from the tank into the bag holding the emulsion formulation. After the gas is introduced into the bag, the three-way valve is closed to prevent leakage of the gas from the container. The container is then agitated to oxygenate the emulsion formulation.

Claims

1. An oxygenation system for the oxygenation of a perfluorocarbon emulsion formulation comprising:

(a) a sealed container having an interior chamber containing a perfluorocarbon emulsion formulation, the container having a sealed multi-purpose port;

(b) a three-way valve having one inlet and at least one outlet, with at least one outlet being connected to the multi purpose port of the container for communication with the interior chamber of the container;

(c) a filter having an inlet and an outlet, the outlet being connected to the inlet of the three-way valve; and

(d) a gas reservoir assembly including a gas reservoir of known volume for containing an oxygen-containing gas and having at least one port connected to the inlet of the filter.

2. The oxygenation system according to claim 1 wherein the system includes a connector inserted through the multi-purpose of the container and connected to at least one outlet of the three-way valve.

3. The system according to claim 2 wherein the connector is a hypodermic needle having a needle portion connected to a female receptacle portion, the multi-purpose port of the container having a rubber septum therein, wherein the needle portion of the hypodermic needle is through the rubber septum to be in communication with the interior chamber of the container, and the hypodermic needle female receptacle is connected to at least one outlet of the three-way valve.

4. The system according to claim 1 wherein the oxygen-containing gas reservoir assembly has an outlet fitted with a first valve and an inlet fitted with a second valve, the inlet being connected to a pressurized oxygen-containing gas source, and the outlet being connected to the inlet of the filter.

5. The system according to claim 1 wherein the oxygen has reservoir assembly includes a gas pressure gauge for determining the gas pressure in the oxygen gas reservoir.

6. The oxygenation system according to claim 1 wherein the sealed multi-purpose port is the only opening in the container for inflow and outflow of fluids.

7. An oxygenation system for the oxygenation of a perfluorocarbon emulsion formulation comprising:

(a) a sealed container having an interior chamber containing a perfluorocarbon emulsion formulation, the container having a sealed multi-purpose port;

(b) a filter having an inlet and an outlet, the outlet being connected to the multi-purpose port of the container for communication with the interior chamber of the container;

(c) a three-way valve having an inlet and at least one outlet, at least one outlet being connected to the inlet of the filter; and

(d) a gas reservoir assembly including a gas reservoir of known volume for containing an oxygen-containing gas and having at least one port connected to the inlet of the three-way valve.

8. The oxygenation system according to claim 7 wherein the system includes a connector inserted through the multi-purpose port of the container and connected to receive the outlet of the filter.

9. The system according to claim 8 wherein the connector is a hypodermic needle having a needle portion connected to a female receptacle portion, the multi-purpose port of said container having a rubber septum therein, wherein the needle portion of the hypodermic needle is through the rubber septum to be in communication with the interior chamber of the container, and the hypodermic needle female receptacle is connected to the outlet of the filter.

10. The oxygenation system according to claim 7 wherein the sealed multi-purpose port is the only opening in the container for inflow and outflow of fluids.

11. An oxygenation system for the oxygenation of a perfluorocarbon emulsion formulation comprising:

(a) a sealed container having an interior chamber containing a perfluorocarbon emulsion formulation, the container having a sealed multi-purpose port;

(b) a three-way valve having one inlet and at least one outlet, at least one outlet being connected to the multi-purpose port of the container for communication with the interior chamber of the container;

(c) a filter having an inlet and an outlet, the outlet being connected to the inlet of the three-way valve;

(d) a gas cartridge of known volume containing an oxygen-containing gas and having an outlet; and

(e) means for connecting the gas cartridge outlet to the filter inlet so that the gas can pass from the gas cartridge, through the filter, through the three-way valve, through the multi-purpose port and the into the container.

12. The oxygenation system according to claim 11 wherein the system includes a connector inserted through the multi-purpose port of the container and connected to at least one outlet of the three-way valve.

13. The system according to claim 12 wherein the connector is a hypodermic needle having a needle portion connected to a female receptacle portion, the multi-purpose port of the container having a rubber septum therein, wherein the needle portion of the hypodermic needle is through the rubber septum to be in communication with the interior chamber of the container, and the hypodermic needle female receptacle is connected to at least one outlet of the three-way valve.

14. The oxygenation system according to claim 11 wherein the sealed multi-purpose port is the only opening in the container for inflow and outflow of fluids.