Disposable cartridge for producing gas-enriched fluids

• US 6,613,280 B2
• Filed: 03/20/2001
• Issued: 09/02/2003
• Est. Priority Date: 03/20/2001
• Status: Expired due to Term

• Current Assignee: TherOx Incorporated (Asahi Kasei Corporation)
• Original Assignee: TherOx Incorporated (Asahi Kasei Corporation)
• Inventors: Patterson, William R., Watson, Gregory P., Zalesky, Paul J., Myrick, Stephen E.
• Primary Examiner(s): Bennett, Henry
• Assistant Examiner(s): Basichas, Alfred
• Application Number:
  US09/813,062
• Publication Number:
  US 20020136662A1
• Time in Patent Office: 896 Days
• Field of Search: 422/44, 422/45, 128/200.14, 128/200.19, 128/200.21, 128/200.22, 604/4.01, 604/6.14, 604/6.16, 261/DIG.28, 261/75, 261/78.1, 261/78.2
• US Class Current: 422/45
• CPC Class Codes: A61M 1/32 Oxygenators without membranes
• CPC Class Codes: A61M 1/3621 Extra-corporeal blood circuits single-needle circuits A61M1/30
• CPC Class Codes: A61M 1/362227 the interface providing means for actuating on functional elements of the cassette, e.g. plungers
• CPC Class Codes: A61M 1/36224 with sensing means or components thereof
• CPC Class Codes: A61M 1/362262 Details of incorporated reservoirs
• CPC Class Codes: A61M 1/362265 Details of valves
• 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 2202/0208 Oxygen
• CPC Class Codes: A61M 2202/0476 Oxygenated solutions
• CPC Class Codes: B01F 23/23413 using nozzles for projecting the liquid into the gas atmosphere

Abstract

A device generates a gas-enriched physiologic fluid and combines it with a bodily fluid to create a gas-enriched bodily fluid. The device may take the form of a disposable cartridge. The cartridge may include a fluid supply chamber for delivering physiologic fluid under pressure to an atomizer. The atomizer delivers fluid droplets into a gas-pressurized atomization chamber to enrich the physiologic fluid with the gas. The gas-enriched physiologic fluid is delivered to a mixing chamber in the cartridge where the gas-enriched physiologic fluid is mixed with a bodily fluid, such as blood, to create a gas-enriched bodily fluid.

Claims

1. A gas-enrichment device comprising:

a housing having a fluid supply chamber, an atomizing chamber, and a mixing chamber therein;

a pump disposed within the fluid supply chamber, the pump adapted to draw a physiologic fluid into the fluid supply chamber through a fluid inlet in the fluid supply chamber and to deliver the physiologic fluid to the atomizing chamber through a fluid outlet in the fluid supply chamber;

an atomizer disposed within the atomizing chamber, the atomizer adapted to receive the physiologic fluid from the fluid outlet of the fluid supply chamber, wherein the atomizing chamber is adapted to receive a gas through a gas inlet in the atomizing chamber, the atomizer having an atomizing nozzle adapted to atomize the physiologic fluid upon delivery into the atomizing chamber to form a gas-enriched physiologic fluid; and

a fluid delivery device disposed within the mixing chamber in a predetermined relationship with a fluid inlet in the mixing chamber, the fluid delivery device adapted to receive the gas-enriched physiologic fluid from the atomizing chamber and to deliver the gas-enriched fluid into the mixing chamber to mix with a bodily fluid adapted to enter the mixing chamber through the fluid inlet in the mixing chamber to form a gas-enriched bodily fluid deliverable through a fluid outlet in the mixing chamber.

2. The device, as set forth in claim 1, wherein the housing comprises an integral plastic structure.

3. The device, as set forth in claim 1, wherein at least a portion of the housing is transparent.

4. The device, as set forth in claim 1, wherein the pump comprises a piston pump.

5. The device, as set forth in claim 1, wherein the pump is adapted to be driven within the fluid supply chamber by an external drive mechanism.

6. The device, as set forth in claim 1, wherein the pump comprises a sterility sheath.

7. The device, as set forth in claim 1, wherein the fluid inlet of the fluid supply chamber comprises a one-way valve that permits the physiologic fluid to be only drawn into the fluid supply chamber.

8. The device, as set forth in claim 1, wherein the fluid outlet of the fluid supply chamber comprises a one-way valve that permits the physiologic fluid to be only expelled from the fluid supply chamber.

9. The device, as set forth in claim 1, wherein the atomizing chamber comprises a fluid inlet that bypasses the atomizer to permit the physiologic fluid to be delivered into the atomizing chamber in non-atomized form.

10. The device, as set forth in claim 9, wherein the fluid inlet comprises a tube oriented to provide substantially tangential flow within the atomizing chamber.

11. The device, as set forth in claim 9, wherein the housing comprises a valve assembly, the valve assembly having a fill valve coupled to the fluid inlet of the atomizing chamber, a flow valve coupled to a fluid outlet of the atomizing chamber, and a flush valve disposed between the fluid outlet of the fluid supply chamber and the fluid delivery device.

12. The device, as set forth in claim 11, wherein the fill valve when open is adapted to permit the physiologic fluid to be delivered into the atomizing chamber through the fluid inlet of the atomizing chamber.

13. The device, as set forth in claim 11, wherein the flow valve when open is adapted to permit the gas-enriched physiologic fluid from the atomizing chamber to flow into the fluid delivery device.

14. The device, as set forth in claim 11, wherein the flush valve when open is adapted to permit the physiologic fluid from the fluid supply chamber to flow into the fluid delivery device.

15. The device, as set forth in claim 11, wherein the flow valve, the flush valve, and the fill valve are adapted to be actuated by respective external actuation devices.

16. The device, as set forth in claim 15, wherein the housing is dimensioned to fit within an enclosure having the respective external actuation devices in a manner that permits actuation of the flow valve, the flush valve, and the fill valve.

17. The device, as set forth in claim 1, wherein the housing comprises a vent valve in the atomizing chamber.

18. The device, as set forth in claim 17, wherein the housing comprises a vent valve in the mixing chamber.

19. The device, as set forth in claim 18, wherein the vent valves in the atomizing chamber and the mixing chamber are adapted to be actuated by respective external actuation devices.

20. The device, as set forth in claim 1, wherein the fluid delivery device comprises at least one capillary.

21. The device, as set forth in claim 20, wherein the at least one capillary is adapted to maintain the gas within the gas-enriched physiologic fluid in solution.

22. The device, as set forth in claim 20, wherein the fluid delivery device terminates in a needle that extends into the mixing chamber.

23. The device, as set forth in claim 20, wherein the at least one capillary is coiled.

24. The device, as set forth in claim 20, wherein the fluid delivery device is positioned within the mixing chamber to facilitate mixing of the gas-enriched physiologic fluid with the bodily fluid and to hinder bubble formation.

25. The device, as set forth in claim 1, wherein the fluid inlet of the mixing chamber is positioned to facilitate vortical flow of the bodily fluid within the mixing chamber.

26. The device, as set forth in claim 1, wherein the housing is structured to facilitate the use of external sensors to monitor fluid within at least one of the chambers.

27. The device, as set forth in claim 26, wherein the housing comprises a flattened portion proximate a location of each external sensor.

28. The device, as set forth in claim 1, wherein the gas-enriched physiologic fluid is gas-supersaturated.

29. The device, as set forth in claim 1, wherein the gas comprises oxygen.

30. The device, as set forth in claim 1, wherein the physiologic fluid comprises saline.

31. The device, as set forth in claim 1, wherein the bodily fluid comprises blood.

32. The device, as set forth in claim 1, comprising a first catheter coupled to the fluid inlet of the mixing chamber and a second catheter coupled to the fluid outlet of the mixing chamber.