Combined percutaneous cardiopulmonary bypass (PBY) and intra-aortic balloon (IAB) access cannula

• US 5,254,097 A
• Filed: 01/06/1992
• Issued: 10/19/1993
• Est. Priority Date: 01/06/1992
• Status: Expired due to Term

• Current Assignee: Cardio Access LLC (Acacia Research Corporation)
• Original Assignee: Datascope Corporation (Getinge AB)
• Inventors: Corrigan, William C. Jr., Capinpin, Manuel L., Schock, Robert B., Lucas, John J.
• Primary Examiner(s): YASKO JR, JOHN D
• Application Number:
  US07/817,399
• Time in Patent Office: 652 Days
• Field of Search: 604/284, 604/83, 604/86, 604/247, 604/256, 604/167, 604/169
• US Class Current: 604/167.04
• CPC Class Codes: A61M 39/04 having pierceable self-sealing members

Abstract

A cannula for performing two or more medical procedures either individually, seriatim or simultaneously, for example, combined percutaneous PBY and IAB procedures, which cannula includes a body having a common leg and two or more access port legs (e.g. a Y-shaped body), one access port for performing one procedure, a second access port for performing a second procedure, and hemostasis structure. A smooth continuous blood flow path is formed by a common lumen of a common leg of the cannula body and a primary lumen formed in a primary access port leg of the cannula body. The secondary access port legs are provided with secondary lumens that communicate with the common lumen.

Claims

1. A cannula adapted for percutaneous insertion into the body of a patient and comprising percutaneous insertion means and a cannula body, said cannula body comprising

a common leg having a distal end, a proximal end and a common lumen therethrough defined by a common lumen wall, said common lumen being in fluid communication with said percutaneous insertion means,

a primary access port leg having a primary lumen defined by a primary lumen wall, said primary lumen being in fluid communication with said common lumen and forming a continuous blood flow path therewith,

a secondary access port leg having a secondary lumen defined by a secondary lumen wall, and

hemostasis means for providing access for percutaneous insertion of a catheter through said secondary lumen and said blood flow path, and for preventing a blood flow from said blood flow path through said secondary lumen.

2. The cannula recited in claim 1, wherein said cannula body is formed of a flexible material.

3. The cannula recited in claim 1, wherein said cannula body is formed of a single-piece of elastomeric material.

4. The cannula recited in claim 1, wherein said hemostasis means comprises a hemostatic valve.

5. The cannula recited in claim 4, wherein said hemostatic valve comprises a passive self-closing valve.

6. The cannula recited in claim 4, wherein said hemostatic valve comprises a duck-bill valve.

7. The cannula recited in claim 4, wherein said hemostatic valve comprises an open-hole valve.

8. The cannula recited in claim 4, wherein said hemostatic valve comprises a perforated diaphragm valve.

9. The cannula recited in claim 4, wherein said hemostatic valve comprises an active valve.

10. The cannula recited in claim 4, wherein said hemostatic valve comprises a Touhy Borst valve.

11. The cannula recited in claim 1, wherein said hemostasis means comprises an obturator cap.

12. The cannula recited in claim 4, wherein a portion of said hemostatic valve forms an integral part of said common lumen wall.

13. The cannula recited in claim 12, wherein said hemostatic valve lies in a plane substantially in line with the common lumen and forms an angle with an axis of the primary lumen.

14. The cannula recited in claim 4, wherein said hemostatic valve comprises a conical portion, a semi-spherical portion and a slit portion, wherein a proximal end of the conical portion is in fluid communication with said secondary lumen, wherein said semi-spherical portion terminates a distal end of the conical portion, wherein said semi-spherical portion has an arcuate perforation therein, and wherein the slit portion is formed integral with the common lumen wall and is in registration with said arcuate perforation.

15. The cannula recited in claim 14, wherein the slit portion lies in a plane substantially parallel to the axis of the common lumen and forms an angle with an axis of the primary lumen.

16. The cannula recited in claim 1, wherein said percutaneous insertion means further comprises a sheath extension disposed at a distal end of said common leg.

17. The cannula recited in claim 1, wherein said percutaneous insertion means comprises a sheath extension in fluid communication with the common lumen, for percutaneous intravascular insertion.

18. The cannula recited in claim 4, wherein said secondary access port leg is substantially coaxial with said common leg.

19. The cannula recited in claim 18, wherein said secondary lumen has a distal end and a proximal end, and wherein said hemostatic valve is disposed at the distal end of said secondary lumen.

20. The cannula recited in claim 4, wherein said primary access port leg is substantially coaxial with said common leg.

21. The cannula recited in claim 20, wherein said secondary lumen has a distal end and a proximal end, and wherein said hemostatic valve is disposed at the distal end of said secondary lumen.

22. The cannula recited in claim 1, wherein said secondary lumen has a distal end and a proximal end, and wherein said hemostatic valve is disposed at the distal end of said secondary lumen.

23. The cannula recited in claim 1, wherein blood can enter said cannula, flow through said blood path from said primary lumen to said common lumen and out of said cannula when said catheter device is resident in said secondary lumen and in said common lumen.

24. The cannula recited in claim 23, wherein said secondary lumen has a distal end and a proximal end, and wherein said hemostatic valve is disposed at the distal end of said secondary lumen.

25. The cannula recited in claim 1, wherein said primary and secondary access port legs are disposed at a proximal end of said common leg.

26. The cannula recited in claim 4, wherein said hemostatic valve is disposed adjacent a proximal end of said common leg.

27. The cannula recited in claim 4, wherein said hemostatic valve is disposed between said secondary lumen and said common lumen.

28. The cannula recited in claim 4, wherein said hemostatic valve is disposed between said secondary lumen and said primary lumen.

29. The cannula recited in claim 1, wherein said cannula body is formed of a rigid material.

30. The cannula recited in claim 1, wherein said cannula body comprises a rigid body shell and internal components forming said common lumen wall, primary lumen wall, secondary lumen wall, and hemostasis means.

31. The cannula recited in claim 1, wherein said cannula body comprises a rigid body forming said common lumen wall, said primary lumen wall and said secondary lumen wall.

32. The cannula recited in claim 1, wherein said hemostasis means comprises a hemostatic valve selected from the group consisting of a passive self-closing valve, a duck-bill valve, an open-hole valve, a perforated diaphragm valve, an active valve, and a Touhy Borst valve.

33. The cannula recited in claim 2, wherein said hemostasis means comprises a hemostatic valve selected from the group consisting of a passive self-closing valve, a duck-bill valve, an open-hole valve, a perforated diaphragm valve, an active valve, and a Touhy Borst valve.

34. The cannula recited in claim 29, wherein said hemostasis means comprises a hemostatic valve selected from the group consisting of a passive self-closing valve, a duck-bill valve, an open-hole valve, a perforated diaphragm valve, an active valve, and a Touhy Borst valve.

35. The cannula recited in claim 30, wherein said hemostasis means comprises a hemostatic valve selected from the group consisting of a passive self-closing valve, a duck-bill valve, an open-hole valve, a perforated diaphragm valve, an active valve, and a Touhy Borst valve.

36. The cannula recited in claim 31, wherein said hemostasis means comprises a hemostatic valve selected from the group consisting of a passive self-closing valve, a duck-bill valve, an open-hole valve, a perforated diaphragm valve, an active valve, and a Touhy Borst valve.

37. The cannula recited in claim 29, wherein said hemostasis means comprises an obturator cap.

38. The cannula recited in claim 30, wherein said hemostasis means comprises an obturator cap.

39. The cannula recited in claim 31, wherein said hemostasis means comprises an obturator cap.

40. The cannula recited in claim 1, wherein said hemostasis means comprises at least two components selected from the group comprised of an obturator cap, a passive valve and an active valve.

41. The cannula recited in claim 1, wherein said hemostasis means comprises at least two components selected from the group comprised of an obturator cap, a duck-bill valve, an open-hole valve, and a perforated diaphragm valve.

42. A cannula adapted to permit passage therethrough of a catheter for percutaneous insertion in the body of a patient, and comprising a cannula body including

a common leg having a common lumen defined by a common lumen wall, said common lumen being in fluid communication with percutaneous insertion means,

at least one primary access port leg, each such primary access port leg having a primary lumen therein defined by a primary lumen wall, each said primary lumen being in fluid communication with the common lumen and forming a continuous blood flow path therewith,

at least one secondary access port leg, each such secondary access port leg having a secondary lumen therein defined by a secondary lumen wall, and

at least one hemostatic valve arranged to provide access for percutaneous insertion of a catheter through said at least one secondary lumen and said blood flow path, and to prevent a blood flow from said blood flow path through said at least one secondary lumen.

43. A cannula adapted for percutaneous insertion into the body of a patient comprising percutaneous insertion means and a cannula body, said cannula comprising

a common leg having a distal end, a proximal end, and a common lumen therethrough defined by a common lumen wall,

a first access port leg having a first lumen defined by a first lumen wall,

first hemostasis means for preventing blood from exiting through said first access port leg when said leg is not in use,

a second access port leg having a second lumen defined by a second lumen wall, and

second hemostasis means for preventing blood from exiting through said second leg when said leg is not in use,

wherein access to said common lumen can be gained through each of said first and second legs.

44. The cannula recited in claim 43, further comprising a third access leg.

45. The cannula recited in claim 44, further comprising hemostasis means for preventing blood from exiting through said third leg when said leg is not in use, and wherein access to said common lumen can be gained through said third leg.

46. The cannula recited in claim 44, further comprising a fourth access leg.

47. The cannula recited in claim 46, further comprising hemostasis means for preventing blood from exiting through said fourth leg when said leg is not in use, and wherein access to said common lumen can be gained through said fourth leg.

48. The cannula recited in claim 44, wherein each of said hemostasis means comprises a hemostasis valve.

49. The cannula recited in claim 45, wherein each of said hemostasis means comprises a hemostasis valve.

50. The cannula recited in claim 47, wherein each of said hemostasis means comprises a hemostasis valve.

51. The cannula recited in claim 48, wherein each said hemostasis valve is selected from the group consisting of a passive self-closing valve, a duck-bill valve, an open-hole valve, a perforated diaphragm valve, an active valve, and a Touhy Borst valve.

52. The cannula recited in claim 49, wherein each said hemostasis valve is selected from the group consisting of a passive self-closing valve, a duck-bill valve, an open-hole valve, a perforated diaphragm valve, an active valve, and a Touhy Borst valve.

53. The cannula recited in claim 50, wherein each said hemostasis valve is selected from the group consisting of a passive self-closing valve, a duck-bill valve, an open-hole valve, a perforated diaphragm valve, an active valve, and a Touhy Borst valve.