Single expandable double lumen cannula assembly for veno-venous ECMO

• US 20050085761A1
• Filed: 08/23/2004
• Published: 04/21/2005
• Est. Priority Date: 08/25/2003
• Status: Active Grant

• Current Assignee: University of Texas System
• Original Assignee: University of Texas System
• Inventors: Zwischenberger, Joseph B., Wang, Dongfang
• Granted Patent: US 7,473,239 B2
• Time in Patent Office: Days
• US Class Current: 604/6.110
• CPC Class Codes: A61M 1/3653 Interfaces between patient blood circulation and extra-corporal blood circuit
• CPC Class Codes: A61M 1/3658 Indicating the amount of purified blood recirculating in the fistula or shunt
• CPC Class Codes: A61M 1/3659 Cannulae pertaining to extracorporeal circulation
• CPC Class Codes: A61M 2025/0024 Expandable catheters or sheaths
• CPC Class Codes: A61M 2025/0031 characterized by lumina for withdrawing or delivering, i.e. used for extracorporeal circuit treatment
• CPC Class Codes: A61M 2025/0035 characterized by a variable lumen cross-section by means of a resilient flexible septum or outer wall
• CPC Class Codes: A61M 25/0026 Multi-lumen catheters with stationary elements catheter assemblies comprising a catheter in combination with a guide tube, sheath or sleeve A61M2025/0681; catheters comprising telescoping coaxial elements A61M2025/0175
• 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: A61M 25/0032 characterized by at least one unconventionally shaped lumen, e.g. polygons, ellipsoids, wedges or shapes comprising concave and convex parts
• CPC Class Codes: A61M 25/0068 Static characteristics of the catheter tip, e.g. shape, atraumatic tip, curved tip or tip structure

Abstract

The present invention provides an apparatus, system, and method of use of a simple, less invasive, self-expandable percutaneous double lumen cannula assembly for VV ECMO that overcomes the limitations and obstacles of the techniques described above. The present invention achieves near theoretical total venous blood drainage, total extracorporeal gas exchange, and prevents recirculation and multiple cannulation, thereby simplifying VV ECMO, decreasing surgical and blood trauma, and expanding its application.

Claims

1. A system for mixing a fluid into a bloodstream of a body, comprising:

a. a drainage cannula adapted to be inserted through both a superior vena cava of a heart of the body and an inferior vena cava of the heart, the drainage cannula having an opening to receive blood from a superior vena cava blood flow and separate opening to receive blood from an inferior vena cava blood flow;

b. an infusion cannula adapted to be inserted into the bloodstream downstream of both the superior vena cava and inferior vena cava;

c. a pump coupled to the drainage cannula and the infusion cannula; and

d. a mixing unit coupled to the pump and adapted to mix the fluid into the bloodstream of the body.

2. The system of claim 1, wherein the drainage cannula and the infusion cannula are formed as a single cannula assembly with a double lumen, one lumen being the drainage cannula and the other lumen being the infusion cannula.

3. The system of claim 1, wherein the infusion cannula is adapted to infuse the fluid into an atrium of the heart through an opening in the infusion cannula.

4. The system of claim 3, wherein the opening in the drainage cannula for the superior vena cava is oriented rotationally away from the opening in the infusion cannula.

5. The system of claim 1, wherein at least one cannula is expandable in cross-sectional area.

6. The system of claim 5, wherein the expandable cannula comprises a heat-sensitive expandable element.

7. The system of claim 6, wherein the heat-sensitive expandable element comprises a memory shape alloy.

8. The system of claim 5, wherein the expandable cannula comprises an expandable sidewall and wherein the sidewall comprises a flexible portion that is adapted to sealingly expand to maintain a flow within the cannula.

9. The system of claim 8, wherein the sidewall comprises a split sidewall having a slot.

10. The system of claim 2, wherein at least one lumen is expandable in cross-sectional area.

11. The system of claim 10, wherein the double lumen is formed within a sidewall of the single cannula assembly and one lumen is separated by a septum from the other lumen.

12. The system of claim 11, wherein the single cannula sidewall is expandable and wherein the sidewall comprises a flexible portion that is adapted to sealingly expand to maintain a flow within the cannula.

13. The system of claim 10, wherein one lumen is formed inside the single cannula assembly and the other lumen is formed outside a sidewall of the single cannula assembly.

14. The system of claim 13, wherein the lumen formed outside the sidewall is expandable in cross-sectional area.

15. The system of claim 1, wherein at least one cannula comprises a non-circular cross-sectional shape.

16. The system of claim 2, further comprising an introducer coupled to an end of the double lumen, single cannula assembly.

17. The system of claim 1, further comprising an expandable seal disposed external to at least one of the cannulae.

18. The system of claim 17, wherein the expandable seal is eccentrically disposed at least partially around at least one of the cannulae.

19. The system of claim 17, wherein the expandable seal comprises an inflatable balloon.

20. The system of claim 1, wherein a relative percentage of volumetric flow between the superior vena cava blood flow and the inferior vena cava blood flow is adjustable.

21. The system of claim 1, wherein the fluid comprises a liquid having one or more perfused gases.

22. The system of claim 1, wherein the mixing unit comprises an oxygenator and the fluid comprises oxygenated blood for veno-venous extracorporeal membrane oxygenation (VV ECMO).

23. The system of claim 1, further comprising a radio opaque portion coupled to the cannula assembly.

24. A system for mixing a fluid into a bloodstream of a body, comprising:

a. a drainage cannula means for discharging blood from both a superior vena cava of a heart of the body and an inferior vena cava of the heart;

b. an infusion cannula means for infusing the fluid into the bloodstream downstream of both the superior vena cava and inferior vena cava;

c. a pump coupled to the drainage cannula means and the infusion cannula means; and

d. a mixing unit coupled to the pump and adapted to mix the fluid into the bloodstream of the body.

25. The system of claim 24, wherein the drainage cannula means and the infusion cannula means are coupled to form a double lumen.

26. The system of claim 25, wherein at least one of the cannula means is expandable in cross-sectional area.

27. The system of claim 24, wherein at least one of the cannula means is expandable in cross-sectional area.

28. The system of claim 27, wherein the expandable cannula means comprises an inside expandable lumen.

29. The system of claim 27, wherein the expandable cannula means comprises an outside expandable lumen.

30. The system of claim 24, wherein at least one of the cannula means comprises a split sidewall.

31. The system of claim 30, wherein the sidewall comprises a sealing flexible portion.

32. The system of claim 24, further comprising an expandable seal disposed external to at least one of the cannulae.

33. The system of claim 32, wherein the expandable seal is eccentrically disposed at least partially around at least one of the cannulae.

34. The system of claim 24, wherein a relative percentage of volumetric flow between the superior vena cava blood flow and the inferior vena cava blood flow is adjustable.

35. The system of claim 24, wherein the mixing unit comprises an oxygenator and the fluid comprises oxygenated blood for VV ECMO.

36. A method of perfusing a fluid into a bloodstream of a body, comprising:

a. discharging blood through a common drainage cannula from a superior vena cava of a heart of the body and an inferior vena cava of the heart;

b. pumping the blood through a mixing unit to combine a fluid with the blood;

c. infusing the fluid with the blood into the body through an infusion cannula.

37. The method of claim 36, wherein infusing the fluid comprises infusing the fluid into an atrium of the body.

38. The method of claim 37, wherein the drainage cannula and infusion cannula are coupled into a double lumen single cannula assembly and further comprising positioning the double lumen single cannula assembly in the body to allow the drainage cannula to drain blood from both vena cava and infuse the blood into the atrium concurrently.

39. The method of claim 38, wherein positioning the double lumen single cannula assembly comprises inserting in a first diameter condition and expanding at least one of the lumen after insertion.

40. The method of claim 39, wherein expanding at least one of the lumen comprises pressurizing the lumen through an infusion flow.

41. The method of claim 40, wherein expanding at least one of the lumen comprises expanding the lumen outside a sidewall of the cannula assembly.

42. The method of claim 40, wherein expanding at least one of the lumen comprises expanding the lumen inside a sidewall of the cannula assembly.

43. The method of claim 36, further comprising sealing an external portion of at least one of the cannulae against a vessel wall.

44. The method of claim 43, wherein sealing the external portion comprises sealing downstream of the drainage from the superior vena cava and upstream from the infusion of the blood into the body.

45. The method of claim 43, wherein sealing the external portion comprises sealing at least one of the cannulae in an eccentric position in the vessel.

46. The method of claim 36, further comprising orienting an opening for the drainage cannula away from an opening for the infusion cannula.

47. A cannula assembly for discharging and infusing blood in a body, comprising:

a. an elongated first portion forming a first lumen and a longitudinal slot formed in a sidewall of the first portion, the slot having a first side and a second side;

b. a flexible member sealingly coupled to the first portion on both sides of the slot to cover the longitudinal slot in an expanded state of the cannula.

48. The cannula assembly of claim 47, further comprising an elongated second portion coupled to an external part of the first portion to form a second lumen external to the first portion.

49. The cannula assembly of claim 48, wherein the second lumen is expandable in cross-sectional area.

50. The cannula assembly of claim 48, further comprising a first opening and a second opening formed in the first lumen and a third opening formed in the second lumen spaced between the first opening and the second opening.

51. The cannula assembly of claim 50, wherein at least one of the first opening and the second opening is adapted to be varied in size.

52. The cannula assembly of claim 47, further comprising a septum disposed in the first portion to create a second lumen in the first portion at least partially longitudinal with the first lumen.

53. The cannula assembly of claim 52, wherein the septum is flexible.

54. The cannula assembly of claim 47, wherein the first portion comprises a memory shape alloy disposed circumferentially around at least part of the first portion.

55. The cannula assembly of claim 47, further comprising a non-circular cross-sectional shaped lumen.

56. The cannula assembly of claim 47, further comprising an expandable seal disposed external to the first portion.

57. The cannula assembly of claim 56, wherein the expandable seal is eccentrically disposed around the first portion.

58. The cannula assembly of claim 47, wherein the cannula is adapted to expand dependent on heat.

59. A cannula assembly for discharging and infusing blood in a body, comprising:

a. an elongated first portion forming a first lumen; and

b. an elongated second portion coupled to the first portion forming a second lumen.

60. The cannula assembly of claim 59, wherein the first lumen is formed within a sidewall of the cannula assembly and the second lumen is formed external to the sidewall.

61. The cannula assembly of claim 60, wherein the second lumen is expandable in cross-sectional area.

62. The cannula assembly of claim 59, wherein the first lumen and the second lumen is formed within a sidewall of the cannula assembly and separated by a septum within the cannula assembly.

63. The cannula assembly of claim 62, wherein the septum is flexible and adapted to allow the second lumen to expand in cross-sectional area.

64. The cannula assembly of claim 59, wherein the cannula assembly is expandable in cross-sectional area and further comprising a longitudinal slot formed in a sidewall of the cannula assembly, the slot having a first side and a second side and a flexible portion sealingly coupled to the cannula assembly on both sides of the longitudinal slot to cover the slot when the cannula assembly is expanded.

65. The cannula assembly of claim 64, wherein the cannula assembly is adapted to expand dependent on heat.

66. The cannula assembly of claim 64, wherein the cannula assembly is adapted to expand with electrical energy applied to the cannula assembly.

67. The cannula assembly of claim 64, further comprising a memory shape alloy disposed circumferentially around at least part of the cannula assembly.

68. The cannula assembly of claim 59, further comprising a first opening and a second opening formed in the first lumen and a third opening formed in the second lumen spaced between the first opening and the second opening.

69. The cannula assembly of claim 68, wherein at least one of the first opening and the second opening is adapted to be varied in size.

70. The cannula assembly of claim 59, wherein at least one of the first lumen and second lumen comprises a non-circular cross-sectional shaped lumen.

71. The cannula assembly of claim 59, further comprising an expandable seal disposed external to a sidewall of the cannula assembly.

72. The cannula assembly of claim 71, wherein the expandable seal is eccentrically disposed at least partially around the cannula assembly.

73. The cannula assembly of claim 59, further comprising an introducer coupled to an end portion of the cannula assembly.