Method for the preparation and delivery of gas-enriched fluids

• US 6,180,059 B1
• Filed: 07/24/1998
• Issued: 01/30/2001
• Est. Priority Date: 06/05/1995
• Status: Expired due to Term

• Current Assignee: TherOx Incorporated (Asahi Kasei Corporation), Wayne State University
• Original Assignee: TherOx Incorporated (Asahi Kasei Corporation)
• Inventors: Gessert, James M., Foerster, Seth A., Zalesky, Paul J., Divino, Vincent Jr., Mest, Robert A., Spears, James Richard
• Primary Examiner(s): Sykes, Angela D.
• Assistant Examiner(s): BIANCO, PATRICIA
• Application Number:
  US09/122,143
• Time in Patent Office: 921 Days
• Field of Search: 604/4.01, 604/5.01, 604/6.14, 604/6.16, 604/4-6, 422/44, 422/45, 128/898
• US Class Current: 422/45
• CPC Class Codes: A61M 1/1678 intracorporal peritoneal dialysis A61M1/28
• 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 1/32 Oxygenators without membranes
• CPC Class Codes: A61M 1/3603 in the same direction
• CPC Class Codes: A61M 1/361 before treatment
• CPC Class Codes: A61M 1/3612 after treatment
• CPC Class Codes: A61M 1/3613 Reperfusion, e.g. of the coronary vessels, e.g. retroperfusion
• CPC Class Codes: A61M 1/3621 Extra-corporeal blood circuits single-needle circuits A61M1/30
• CPC Class Codes: A61M 1/3626 Gas bubble detectors
• CPC Class Codes: A61M 2025/0031 characterized by lumina for withdrawing or delivering, i.e. used for extracorporeal circuit treatment
• CPC Class Codes: A61M 2025/0036 with more than four lumina
• CPC Class Codes: A61M 2025/004 characterized by lumina being arranged circumferentially
• CPC Class Codes: A61M 2202/0007 introduced into the body
• CPC Class Codes: A61M 2202/0476 Oxygenated solutions
• CPC Class Codes: A61M 25/0028 characterized by features relating to at least one lumen located at the proximal part of the catheter, e.g. alterations in lumen shape or valves catheter hubs A61M25/0097
• CPC Class Codes: A61M 25/0029 characterized by features relating to least one lumen located at the middle part of the catheter, e.g. slots, flaps, valves, cuffs, apertures, notches, grooves or rapid exchange ports catheter shaft surface irregularities A61M2025/006
• CPC Class Codes: C01B 13/02 Preparation of oxygen by liquefying F25J

Abstract

A gas-enriched fluid is provided by the combination of a first fluid, such as a patient'"'"'s blood, with a second gas-supersaturated fluid, such as an oxygen supersaturated fluid. In this example, a catheter assembly includes a portion that receives the patient'"'"'s blood from a pump and that receives the oxygen supersaturated fluid from an appropriate fluid source. The oxygen supersaturated fluid is advantageously combined with the blood in an area of laminar flow, and then this gas-enriched fluid is delivered to the patient through an appropriate lumen coupled to the portion of the catheter assembly.

Claims

1. A method for the delivery of a gas-enriched fluid comprising:

providing a supply of a first fluid;

providing a supply of a gas-supersaturated fluid;

forming the gas-enriched fluid by combining within a catheter the first fluid and the gass-supersaturated fluid; and

transferring the gas-enriched fluid from the catheter to a patient.

2. The method of claim 1 wherein the transfer of the gas-enriched fluid is through the catheter to predetermined site within a human body.

3. The method of claim 2 wherein the site is proximate the heart.

4. The method of claim 2 wherein the site is proximate the brain.

5. The method of claim 2 wherein the site is within a circulatory vessel.

6. The method of claim 1 wherein the first fluid comprises blood.

7. The method of claim 1 wherein the gas-supersaturated fluid comprises an oxygen-supersaturated fluid.

16. The method of claim 1 wherein the first fluid comprises blood.

17. The method of claim 1 wherein the gas-supersaturated fluid comprises an oxygen-supersaturated fluid.

18. The method of claim 1 wherein the first fluid comprises a blood substitute.

19. The method of claim 1 wherein the gas-enriched fluid comprises an oxygen-enriched physiologic liquid.

8. A method for increasing a blood oxygen level comprising combining within a catheter blood and oxygen-supersaturated fluid.

9. The method of claim 8 wherein the blood oxygen level increased is blood partial pressure of oxygen.

10. The method of claim 9 wherein the blood partial pressure of oxygen is increased to over about 90-110 mm Hg.

11. The method of claim 9 wherein the blood partial pressure of oxygen is increased to over about 500 mm Hg.

12. The method of claim 9 wherein the blood partial pressure of oxygen is increased to about 760 mm Hg.

13. The method of claim 9 wherein the blood partial pressure of oxygen is increased to over 760 mm Hg.

14. The method of claim 8 wherein the blood oxygen level increased is hemoglobin saturation.

15. A method for forming a gas-enriched fluid for delivery to a patient comprising:

providing a supply of a first fluid; and

combining within a catheter the supply of first fluid with a gas-supersaturated fluid to form the gas-enriched fluid.

20. A method of forming a gas-enriched fluid for delivery to a patient, the method comprising the acts of:

flowing a first fluid through a first fluid passageway;

flowing a second fluid through a second fluid passageway, the second fluid comprising a gas-supersaturated fluid; and

combining within a catheter at an intersection between the first fluid passageway and the second fluid passageway the first fluid and the second fluid to form the gas-enriched fluid.

21. The method of claim 20, further comprising the act of:

coupling the first fluid passageway to a supply of the first fluid.

22. The method of claim 20, wherein the first fluid comprises blood.

23. The method of claim 20, further comprising the acts of:

placing a distal end of a blood draw assembly within the patient'"'"'s body to withdraw the blood;

coupling a proximal end of the blood draw assembly to an inlet of a pump;

coupling a first end of a tube to an outlet of the pump; and

coupling a second end of the tube to the first fluid passageway.

24. The method of claim 20, further comprising the act of:

coupling the second fluid passageway to a supply of gas-supersaturated fluid.

25. The method of claim 20, further comprising the act of:

combining the first fluid and the second fluid in a region of substantially laminar flow.

26. The method of claim 20, wherein first fluid and the second fluid combine within a

proximal portion of the catheter, and wherein the catheter comprises a distal portion adapted to be positioned within a patient'"'"'s body for delivering the gas-enriched fluid to a site within the patient'"'"'s body.

27. A method of forming hyperbaric blood for delivery to a patient comprising the steps of:

withdrawing blood from a patient; and

combining within a catheter the blood and an oxygen-supersaturated fluid to form the hyperbaric blood.

28. The method of claim 27, wherein the hyperbaric blood has a pO₂ of between about 800 mm Hg and about 1300 mm Hg.

29. The method of claim 27, wherein the catheter is adapted for the delivery of blood proximate the heart.

30. The method of claim 27, wherein the catheter is adapted for the delivery of blood proximate the brain.

31. The method of claim 27, wherein the catheter is adapted for the delivery of blood proximate a tumor.

32. The method of claim 27, wherein the delivery is in conjunction with a drug fluid infusion therapy.

33. The method of claim 27, wherein the delivery is in conjunction with radiation therapy.

34. The method of claim 33, wherein the delivery occurs prior to the delivery of radiation to the patient.

35. The method of claim 27, wherein the oxygen-supersaturated fluid is provided via one or more capillaries having an inner diameter in the range of about 20 μ

m to about 1000 μ

m.

36. A method of forming oxygen-enriched blood for delivery to a patient comprising the steps of:

providing a supply of blood;

providing a supply of an oxygen-supersaturated fluid; and

combining within a catheter the supply of blood and the supply of oxygen-supersaturated fluid to form the oxygen-enriched blood.

37. The method of claim 36, wherein the oxygen-supersaturated fluid is provided to the catheter via a capillary having an inner diameter of between about 20 μ

m and about 1000 μ

.

38. The method of claim 36, wherein the oxygen-supersaturated fluid is provided to the catheter via a capillary having an inner diameter of about 100 μ

m.

39. The method of claim 36, wherein the supply of blood comprises blood withdrawn from the patient.

40. The method of claim 36, wherein the oxygen-enriched blood has a pO₂ greater than about 760 mm Hg.