System and method for oxygenation of the pericardium

• US 5,213,570 A
• Filed: 12/14/1990
• Issued: 05/25/1993
• Est. Priority Date: 12/14/1990
• Status: Expired due to Term

• Current Assignee: Mallinckrodt Medical Inc. (Mallinckrodt plc)
• Original Assignee: Mallinckrodt Medical Inc. (Mallinckrodt plc)
• Inventors: VanDeripe, Donald R.
• Primary Examiner(s): Hirsch, Paul J.
• Application Number:
  US07/627,178
• Time in Patent Office: 893 Days
• Field of Search: 604/27, 604/28, 604/96, 604/158
• US Class Current: 604/28
• CPC Class Codes: A61M 1/32 Oxygenators without membranes
• CPC Class Codes: A61M 1/77 Suction-irrigation systems aspiration tips supplying fluids A61M1/85; specific for negative pressure wound therapy A61M1/92; combined with tracheal tubes A61M16/0463
• CPC Class Codes: A61M 1/85 with gas or fluid supply means, e.g. for supplying rinsing fluids or anticoagulants for negative pressure wound therapy A61M1/92, A61M1/94; combined with tracheal tubes A61M16/0463; dental instruments with combined rinsing and aspirating A61C17/0208
• CPC Class Codes: A61M 2025/0002 with a pressure sensor at the distal end
• CPC Class Codes: A61M 2202/0476 Oxygenated solutions
• CPC Class Codes: A61M 2205/3344 Measuring or controlling pressure at the body treatment site
• CPC Class Codes: A61M 2205/3351 Controlling upstream pump pressure
• CPC Class Codes: A61M 2205/3355 Controlling downstream pump pressure
• CPC Class Codes: A61M 2210/122 Pericardium
• CPC Class Codes: A61M 3/02 Enemata; Irrigators

Abstract

The present invention relates to a system and method for oxygenation of ischemic tissue. In particular, the present invention relates to a system and method for supplying oxygen to the myocardium of the heart through means other than the coronary arteries. The system of the present invention comprises a catheter which may be used to infuse preoxygenated carrier solutions, such as perfluorocarbon emulsions, directly into the pericardial space; i.e. the space between the pericardium and the epicardial surface.

Claims

1. A system for oxygenation of the heart, comprising

a guiding catheter;

a solution delivery catheter; and

means for supplying preoxygenated carrier solution through said delivery catheter;

wherein said guiding catheter provides means to guide said delivery catheter into the pericardial space between the pericardium and the epicardial surface of the heart;

wherein said delivery catheter is constructed so it may be threaded through said guiding catheter and includes means to contact the interior of the pericardial space; and

wherein said means for supplying preoxygenated carrier solution comprises means for administering said carrier solution through said delivery catheter directly into the pericardial space.

2. A system according to claim 1, wherein said guiding catheter comprises a two lumen catheter, wherein a first lumen is capable of providing a slight vacuum, and a second lumen is capable of guiding said delivery catheter to the pericardial space.

3. A system according to claim 1, wherein said guiding catheter comprises a concentric dual lumen catheter, wherein an outer lumen is capable of providing a slight vacuum, and an inner lumen is capable of guiding said delivery catheter to the pericardial space.

4. A system according to claim 1, wherein said guiding catheter includes fiber optic guidance means.

5. A system according to claim 1, wherein said carrier solution is at least one solution selected from the group consisting of a normal physiological saline, 5% dextrose water, buffer solutions, electrolyte formulations, and emulsions of any aromatic or non-aromatic fluorocarbon.

6. A system according to claim 5, wherein said carrier solution is isotonic with respect to the cardiac lymph fluid.

7. A system according to claim 5, wherein said carrier solution is an emulsion of a emulsifying agent and at least one perfluorocarbon compound selected from the group consisting of perfluorodecalin, perfluorooctylbromide, perfluoromethyladamantane, perfluorobromoalkyl-ethers, Fluosol-DA 20%, perfluorohexylether, perfluorobutylethene, perfluoroisoproylhexylethene, perfluorobutylhexylethene, the general classes of perfluoroalkylethers, perfluoroalkylalkenes, perfluoroalkylarylethers, perfluoroalkylarylalkenes, perfluoroarylethers, and perfluoroarylalkenes, and other perfluoronated compounds which can be acceptably emulsified.

8. A system according to claim 7, wherein said perfluorocarbon compound is at least one compound selected from the group consisting of Fluosol-DA 20%, perfluorooctylbromide, perfluorodecalin, perfluoromethyladamantane, perfluorobromoisobutylether.

9. A system according to claim 7, wherein said perfluorocarbon compound has a molecular weight of about 400 to 700.

10. A system according to claim 9, wherein said perfluorocarbon compound has a molecular weight of about 450 to 550.

11. A system according to claim 7, wherein said emulsifying agent is selected from the group consisting of natural emulsifying agents or synthetic emulsifying agents or combinations thereof.

12. A system according to claim 11, wherein said emulsifying agent is at least one agent selected from the group consisting of natural egg yolk phospholipid and fluorinated surfactants.

13. A system according to claim 7, wherein said emulsion is a macroemulsion having an average particle size of 50 to 3000 nanometers.

14. A system according to claim 13, wherein said average particle size is 100 to 400 nanometers.

15. A system according to claim 7, wherein said emulsion is a microemulsion having an average particle size of 10 to 100 nanometers.

16. A system according to claim 15, wherein said emulsion is a microemulsion having an average particle size of 30 to 60 nanometers.

17. A system according to claim 1, said system being capable of delivering 10 to 2000 milliliters of said carrier solution to the pericardial space over a period of 30 minutes to 6 hours.

18. A system according to claim 1, wherein said carrier solution is delivered to the pericardial space at a temperature of 20 to 42 degrees centigrade.

19. A system according to claim 18, wherein said carrier solution is delivered at a temperature of 37 degrees centigrade.

20. A system according to claim 1, wherein said delivery catheter can deliver therapeutic drugs and nutrients into the pericardial space.

21. A system according to claim 20, wherein said, therapeutic drugs are selected from the group consisting of lidocaine, throbolytic agents, anti-inflammatory drugs, and drugs which act to attenuate reperfusion damage to the heart.

22. A system according to claim 20, wherein said nutrients are selected from the group consisting of glucose and fatty acids.

23. A system according to claim 22, wherein said fatty acids can be chosen from the group consisting of C2 to C18 chain length fatty acids.

24. A system according to claim 20, wherein said carrier solution, said therapeutic drugs and said nutrients can be delivered simultaneously to the pericardial space.

25. A system according to claim 1, which may be used following a myocardial infarction to provide oxygen to the ischemic tissue in the myocardium.

26. A system according to claim 1, which may be used during a percutaneous transluminal coronary angioplasty, so as to prevent the development of ischemic tissue in the myocardium.

27. A system to claim 5, wherein said carrier solution is hypotonic with respect to the cardiac lymph fluid.

28. A system for oxygenation of body tissue, comprising

a guiding catheter;

a solution delivery catheter; and

means for supplying preoxygenated carrier solution through said delivery catheter;

wherein said guiding catheter provides means to guide said delivery catheter into a space between a covering membrane of the tissue and the surface of the tissue;

wherein said delivery catheter is constructed so it may be threaded through said guiding catheter and includes means to contact the interior of said space; and

wherein said means for supplying preoxygenated carrier solution comprises means for administering said carrier solution through said delivery catheter directly into said space.

29. A system according to claim 28, wherein said tissue is the brain, and said system may be used to administer said carrier solution under the dura into the cerebrospinal fluid covering the surface of the brain.

30. A method of delivering a preoxygenated carrier solution to the heart of a patient, said method comprising;

inserting a guiding catheter through the vasculature of the patient until said guiding catheter is in contact with the pericardium;

providing a slight vacuum through said guiding catheter so as to separate the pericardium from the heart thereby forming a pericardial space between the pericardium and the epicardial surface of the heart;

puncturing the pericardium;

threading a delivery catheter through said guiding catheter until said delivery catheter is in contact with the interior of the pericardial space; and

delivering said carrier solution through said delivery catheter and into the pericardial space.

31. A method according to claim 30, wherein oxygen is provided to ischemic tissue in the myocardium following a myocardial infarction.

32. A method according to claim 30, wherein oxygen is provided to the myocardium during a percutaneous transluminal angioplasty procedure so as to prevent the development of ischemic tissue.

33. A method according to claim 30, wherein said guiding catheter comprises a two lumen catheter, wherein a first lumen is capable of providing a slight vacuum, and a second lumen is capable of guiding said delivery catheter to the pericardial space.

34. A method according to claim 30, wherein said guiding catheter comprises a concentric dual lumen catheter, wherein an outer lumen is capable of providing a slight vacuum, and an inner lumen is capable of guiding said delivery catheter to the pericardial space.

35. A method according to claim 30, wherein said guiding catheter includes fiber optic guidance means.

36. A method according to claim 30, wherein said carrier solution is at least one solution selected from the group consisting of a normal physiological saline, 5% dextrose water, buffer solutions, electrolyte formulations, and emulsions of any aromatic or non-aromatic fluorocarbon.

37. A method according to claim 36, wherein said carrier solution is isotonic with respect to the cardiac lymph fluid.

38. A method according to claim 36, wherein said carrier solution is an emulsion of a emulsifying agent and at least one perfluorocarbon compound selected from the group consisting of perfluorodecalin, perfluorooctylbromide, perfluoromethyladamantane, perfluorobromoalkyl-ethers, Fluosol-DA 20%, perfluorohexylether, perfluorobutylethene, perfluoroisoproylhexylethene, perfluorobutylhexylethene, the general classes of perfluoroalkylethers, perfluoroalkylalkenes, perfluoroalkylarylethers, perfluoroalkylarylalkenes, perfluoroarylethers, and perfluoroarylalkenes, and other perfluoronated compounds which can be acceptably emulsified.

39. A method according to claim 38, wherein said perfluorocarbon compound is at least one compound selected from the group consisting of Fluosol-DA 20%, perfluorooctylbromide, perfluorodecalin, perfluoromethyladamantane, perfluorobromoisobutylether.

40. A method according to claim 38, wherein said perfluorocarbon compound has a molecular weight of about 400 to 700.

41. A method according to claim 40, wherein said perfluorocarbon compound has a molecular weight of about 450 to 550.

42. A method according to claim 38, wherein said emulsifying agent is selected from the group consisting of natural emulsifying agents or synthetic emulsifying agents or combinations thereof.

43. A method according to claim 42, wherein said emulsifying agent is at least one agent selected from the group consisting of natural egg yolk phospholipid and fluorinated surfactants.

44. A method according to claim 38, wherein said emulsion is a macroemulsion having an average particle size of 50 to 3000 nanometers.

45. A method according to claim 44, wherein said average particle size is 100 to 400 nanometers.

46. A method according to claim 38, wherein said emulsion is a microemulsion having an average particle size of 10 to 100 nanometers.

47. A method according to claim 46, wherein said emulsion is a microemulsion having an average particle size of 30 to 60 nanometers.

48. A method according to claim 30, wherein 10 to 2000 milliliters of said carrier solution are delivered to the pericardial space over a period of 30 minutes to 6 hours.

49. A method according to claim 30, wherein said carrier solution is delivered to the pericardial space at a temperature of 20 to 42 degrees centigrade.

50. A method according to claim 49, wherein said carrier solution is delivered at a temperature of 37 degrees centigrade.

51. A method according to claim 30, wherein therapeutic drugs and nutrients are also delivered into the pericardial space.

52. A method according to claim 51, wherein said therapeutic drugs are selected from the group consisting of lidocaine, throbolytic agents, anti-inflammatory drugs, and drugs which act to attenuate reperfusion damage to the heart.

53. A method according to claim 51, wherein said nutrients are selected from the group consisting of glucose and fatty acids.

54. A method according to claim 53, wherein said fatty acids can be chosen from the group consisting of C2 to C18 chain length fatty acids.

55. A method according to claim 51, wherein said carrier solution, said therapeutic drugs and said nutrients are delivered simultaneously to the pericardial space.

56. A method according to claim 36, wherein said carrier solution is hypotonic with respect to the cardiac lymph fluid.

57. A method of oxygenating body tissue of a patient, said method comprising;

inserting a guiding catheter through the vasculature of the patient until said guiding catheter is in contact with a membrane surrounding said body tissue;

providing a slight vacuum through said guiding catheter so as to separate the membrane from the tissue surface thereby forming a space between the membrane and the tissue surface;

puncturing the membrane;

threading a delivery catheter through said guiding catheter until said delivery catheter is in contact with the interior of said space; and

delivering said carrier solution through said delivery catheter and into said space.

58. A method according to claim 57, wherein said tissue is the brain, and said carrier solution is delivered under the dura into the cerebrospinal fluid covering the surface of the brain.