System and method for oxygenation of the heart using subpericardial fluids

• US 5,137,510 A
• Filed: 04/12/1991
• Issued: 08/11/1992
• Est. Priority Date: 12/14/1990
• Status: Expired due to Term

• Current Assignee: Mallinckrodt Medical Incorporated St Louis MO
• Original Assignee: Mallinckrodt Medical Inc. (Mallinckrodt plc)
• Inventors: VanDeripe, Donald R.
• Primary Examiner(s): Mancene, Gene
• Assistant Examiner(s): Lynch, Michael
• Application Number:
  US07/684,421
• Time in Patent Office: 487 Days
• Field of Search: 604/27, 604/28, 604/96, 604/158, 604/49, 604/51, 604/52, 604/53, 128/DIG. 12
• 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. The preoxygenated solutions may be periodically or continuously withdrawn and fresh solutions then infused into the pericardial space.

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;

wherein said means for supplying preoxygenated carrier solution comprises means for administering said carrier solution through said delivery catheter directly into the pericardial space, withdrawing said carrier solution from the pericardial space, and replenishing said carrier solution to the pericardial space.

2. A system according to claim 1, wherein said delivery catheter also includes means for withdrawing carrier solution from the pericardial space, and means for monitoring of pericardial fluid pressure.

3. A system according to claim 2, wherein said delivery catheter comprises a three lumen catheter, a first lumen for delivery of carrier solution to the pericardial space, a second lumen for withdrawing carrier solution from the pericardial space, and a third lumen for monitoring pericardial fluid pressure.

4. A system according to claim 3, wherein delivery and withdrawal of carrier solution, and monitoring of pericardial fluid pressure may be carried out simultaneously.

5. A system according to claim 3, 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 three lumen catheter to the pericardial space.

6. A system according to claim 3, 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 three lumen catheter to the pericardial space.

7. A system according to claim 1, wherein said carrier solution is periodically withdrawn from the pericardial space, and fresh carrier solution is infused to the pericardial space.

8. A system according to claim 7, wherein said carrier solution which has been withdrawn from the pericardial space, is reoxygenated by gas exchange in an oxygen-carbon dioxide gas exchanger, and then is reinfused to the pericardial space.

9. A system according to claim 1, wherein said carrier solution is continuously withdrawn from the pericardial space, and fresh carrier solution is simultaneously infused to the pericardial space.

10. A system according to claim 9, wherein said carrier solution which has been withdrawn from the pericardial space, is reoxygenated by gas exchange in an oxygen-carbon dioxide gas exchanger, and then is reinfused to the pericardial space.

11. A system according to claim 1, 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.

12. A system according to claim 11, wherein said perfluorocarbon compound is at least one compound selected from the group consisting of Fluosol-DA 20%, perfluorooctylbromide, perfluorodecalin, perfluoromethyladamantane, perfluorobromoisobutylether.

13. A system according to claim 11, wherein said emulsion has an average particle size of 50 to 50,000 nanometers.

14. A system according to claim 13, wherein said average particle size is 100 to 30,000 nanometers.

15. A system according to claim 1, wherein said carrier solution is at least one perfluorocarbon compound selected from the group consisting of perfluorodecalin, perfluorooctylbromide, perfluoromethyladamantane, perfluorobromoalkylethers, 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.

16. A system according to claim 15, wherein said perfluorocarbon compound is at least one compound selected from the group consisting of Fluosol-DA 20%, perfluorooctylbromide, perfluorodecalin, perfluoromethyladamantane, perfluorobromoisobutylether.

17. 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.

18. 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;

wherein said means for supplying preoxygenated carrier solution comprises means for administering said carrier solution through said delivery catheter directly into said space, withdrawing said carrier solution from said space, and replenishing said carrier solution to said space.

19. A system according to claim 18, 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.

20. 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;

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

withdrawing carrier solution from and replenishing carrier solution to the pericardial space.

21. A method according to claim 20, wherein oxygen is provided to ischemic tissue in the myocardium following a myocardial infarction.

22. A method according to claim 20, wherein oxygen is provided to the myocardium during a percutaneous transluminal angioplasty procedure so as to prevent the development of ischemic tissue.

23. A method according to claim 20, wherein said delivery catheter also includes means for withdrawing carrier solution from the pericardial space, and means for monitoring of pericardial fluid pressure.

24. A method according to claim 23, wherein said delivery catheter comprises a three lumen catheter, a first lumen for delivery of carrier solution to the pericardial space, a second lumen for withdrawing carrier solution from the pericardial space, and a third lumen for monitoring pericardial fluid pressure.

25. A method according to claim 24, wherein delivery and withdrawal of carrier solution, and monitoring of pericardial fluid pressure may be carried out simultaneously

26. A method according to claim 23, 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 three lumen catheter to the pericardial space.

27. A method according to claim 23, 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 three lumen catheter to the pericardial space.

28. A method according to claim 20, wherein said carrier solution is periodically withdrawn from the pericardial space, and fresh carrier solution is infused to the pericardial space.

29. A method according to claim 28, wherein said carrier solution which has been withdrawn from the pericardial space, is reoxygenated by gas exchange in an oxygen-carbon dioxide gas exchanger, and then is reinfused to the pericardial space.

30. A method according to claim 20, wherein said carrier solution is continuously withdrawn from the pericardial space, and fresh carrier solution is simultaneously infused to the pericardial space.

31. A method according to claim 30, wherein said carrier solution which has been withdrawn from the pericardial space, is reoxygenated by gas exchange in an oxygen-carbon dioxide gas exchanger, and then is reinfused to the pericardial space.

32. A method according to claim 20, 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.

33. A method according to claim 32, wherein said perfluorocarbon compound is at least one compound selected from the group consisting of Fluosol-DA 20%, perfluorooctylbromide, perfluorodecalin, perfluoromethyladamantane, perfluorobromoisobutylether.

34. A method according to claim 32, wherein said emulsion has an average particle size of 50 to 50,000 nanometers.

35. A method according to claim 34, wherein said average particle size is 100 to 30,000 nanometers.

36. A method according to claim 20, wherein said carrier solution is at least one perfluorocarbon compound selected from the group consisting of perfluorodecalin, perfluorooctylbromide, perfluoromethyladamantane, perfluorobromoalkylethers, 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.

37. A method according to claim 36, wherein said perfluorocarbon compound is at least one compound selected from the group consisting of Fluosol-DA 20%, perfluorooctylbromide, perfluorodecalin, perfluoromethyladamantane, perfluorobromoisobutylether.

38. 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;

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

withdrawing carrier solution from and replenishing carrier solution to said space.

39. A method according to claim 38, 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.