Pulmonary and circulatory blood flow support devices and methods for heart surgery procedures

• US 6,532,964 B2
• Filed: 01/13/1999
• Issued: 03/18/2003
• Est. Priority Date: 07/11/1997
• Status: Expired due to Term

• Current Assignee: Maquet Cardiovascular LLC (Getinge AB)
• Original Assignee: A-Med Systems, Inc.
• Inventors: Kanz, William Russell, Aboul-Hosn, Walid Najib
• Primary Examiner(s): Millin, V.
• Assistant Examiner(s): CAMPEN, KELLY SCAGGS
• Application Number:
  US09/231,320
• Publication Number:
  US 20020026944A1
• Time in Patent Office: 1,525 Days
• Field of Search: 128/898, 623/1.15, 623/3.15, 600/16, 600/17, 604/43, 604/4, 604/151, 415/900
• US Class Current: 128/898
• CPC Class Codes: A61F 2/82 Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents stent-grafts for tubular structures of the body other than blood vessels A61F2/04; stent-grafts for blood vessels A61F2/07; instruments specially adapted for placement or removal of stents or stent-grafts A61F2/95; for closing wounds, or holding wounds closed A61B17/04 - A61B17/115; dilators A61M29/00
• CPC Class Codes: A61M 60/135 inside a blood vessel, e.g. using grafting
• CPC Class Codes: A61M 60/148 in line with a blood vessel using resection or like techniques, e.g. permanent endovascular heart assist devices
• CPC Class Codes: A61M 60/165 implantable in, on, or around the heart
• CPC Class Codes: A61M 60/174 discharging the blood to the ventricle or arterial system via a cannula internal to the ventricle or arterial system
• CPC Class Codes: A61M 60/237 the blood flow through the rotating member having mainly axial components, e.g. axial flow pumps
• CPC Class Codes: A61M 60/411 generated by an electromotor
• CPC Class Codes: A61M 60/414 transmitted by a rotating cable, e.g. for blood pumps mounted on a catheter
• CPC Class Codes: A61M 60/857 Implantable blood tubes
• CPC Class Codes: A61M 60/861 Connections or anchorings for connecting or anchoring pumps or pumping devices to parts of the patient's body
• CPC Class Codes: A61M 60/896 having flexible or resilient parts, e.g. flap valves

Abstract

Pump and cannula systems inserted through the right side and/or left side of the heart provide protection against collapse of the heart chambers and veins and arteries and provide supplemental blood flow through same to enable beating heart bypass surgery on all vessels of the heart, including lateral and posterior vessels. The invention eliminates the use of cardiopulmonary bypass (CPB) machines. The invention further provides stents adapted for protecting from vein, artery, atrium and/or ventricle collapse during beating heart bypass surgery.

Claims

1. A method for performing beating heart bypass surgery comprising the steps of:

inserting the cannula portion of a pump and cannula system through the tricuspid valve, through the pulmonary valve and a sufficient length into the pulmonary artery to prevent collapse of the right atrium, right ventricle or pulmonary artery when the heart is stressed, lifted or displaced during surgery; and

pumping blood from upstream of the pulmonary valve into the pulmonary artery to augment the flow of blood through the pulmonary valve produced by the beating heart.

2. A method for performing beating heart bypass surgery comprising the steps of:

providing a pump having a pump intake port and a pump outflow port;

inserting a first cannula through an incision in the wall of the right atrium such that an inflow port of the first cannula is disposed in the right atrium;

inserting a second cannula through the first cannula such that the second cannula extends through the tricuspid valve, through the pulmonary valve, and a sufficient length into the pulmonary artery, the first and second cannulas serving to prevent collapse of the right atrium, right ventricle and pulmonary artery when the heart is lifted or displaced during surgery;

connecting the pump intake port to the first cannula;

connecting the pump outflow port to the second cannula; and

operating the pump to pump blood from the right atrium through the pump and into the pulmonary artery.

3. A method for sustaining sufficient blood flow in the patient during heart surgery comprising the steps of:

inserting the cannula portion of a pump and cannula system through the interior of one side of the heart to extend the cannula into at least one of the pulmonary artery and aorta; and

adjusting the pump output during the surgery to provide sufficient blood flow in the patient during the surgery.

4. The method according to claim 3 wherein the blood flow is pulmonary blood flow to the lungs of the patient.

5. The method according to claim 3 wherein the blood flow is circulatory aortic blood flow to the body of the patient.

7. A method for performing beating heart surgery which comprises:

inserting in one side of the heart a tubular member adapted to protect the blood flow path through the heart when the portion of the heart having the tubular member is collapsed or kinked; and

performing beating heart bypass surgery while the tubular member is in place in the heart.

6. A method according to claim 8 and further, comprising the steps of:

inserting the cannula portion of a right heart support pump and cannula system through the interior of the right side of the heart to extend into the pulmonary artery;

inserting the cannula portion of the left heart support pump and cannula system through the interior of the left side of the heart to extend into the aorta; and

adjusting each pump output during the surgery to provide sufficient pulmonary blood flow and sufficient aortic circulatory blood flow in the patient during surgery.

8. The method according to claim 7 wherein the tubular member is placed in the right side of the heart.

9. The method according to claim 7 wherein the tubular member is placed in the left side of the heart.

10. The method of performing beating heart surgery as in claim 7, wherein the tubular member comprises one of a cannula and a stent.

11. A method for performing beating heart bypass surgery comprising the steps of:

providing a pump and cannula system having an inflow cannula, an outflow cannula, and a blood pump communicatively coupled therebetween for transporting blood from an inflow port formed in the inflow cannula to an outflow port formed in the outflow cannula;

arranging the pump and cannula system such that the inflow port is disposed in the right atrium and the outflow port is disposed in the pulmonary artery; and

operating the pump to transport blood from the right atrium to the pulmonary artery and thereby augment the pulmonary blood flow during beating heart bypass surgery.

12. A method of performing beating heart surgery, comprising the step of maintaining at least partial blood flow through a protected blood flow path within a portion of at least one of the vena cava, the right atrium, the right ventricle and pulmonary artery of a beating heart, wherein the step of maintaining at least partial blood flow involves the step of pumping blood through said protected blood flow path by the action of the beating heart.

13. The method of claim 12 and further, wherein said protected blood flow path is established by positioning a conduit within at least one of the vena cava, the right atrium, the right ventricle, and the pulmonary artery.

14. The method of claim 13 and further, wherein said conduit is provided as a stent deployed within at least one of the vena cava and the pulmonary artery.

15. The method of claim 13 and further, wherein said conduit is provided extending through the pulmonary valve and including a fluid inlet aperture disposed within the right ventricle.

16. The method of claim 15 and further, wherein said conduit is introduced through the wall of the right ventricle for passage through the pulmonary valve.

17. The method of claim 16 and further, wherein said conduit is provided with a blocking member for preventing fluid flow through the wall of the right ventricle.

18. The method of claim 15 and further, wherein said conduit is provided extending through the tricuspid valve and including a fluid inlet aperture disposed within the right atrium.

19. The method of claim 18 and further, wherein said conduit is introduced into the right atrium through the wall of the right atrium for passage through the tricuspid valve.

20. The method of claim 19 and further, wherein said conduit is provided with a blocking member for preventing fluid flow through the wall of the right atrium.

21. The method of claim 18 and further, wherein said conduit is introduced through the vena cava for passage into the right atrium.

22. The method of claim 18 and further, wherein said conduit is provided with a valve for preventing fluid back flow from the right ventricle into the right atrium.

23. The method of claim 15 and further, wherein said conduit is provided with a valve for preventing fluid back flow from the pulmonary artery into the right ventricle.

24. The method of claim 13 and further, wherein said conduit is positioned at least partially within the right atrium and extending through the tricuspid valve to pre-load the right ventricle.

25. The method of claim 24 and further, wherein said conduit is provided with a valve for preventing fluid back flow from the right ventricle into the right atrium.

26. The method of claim 24 and further, wherein said conduit is provided having at least one fluid inlet aperture disposed within the right atrium.

27. The method of claim 24 and further, wherein said conduit is maintained in position through the use of a handle member.

28. The method of claim 13 further, wherein said conduit is maintained in position through the use of a handle member.

29. The method of claim 13 and further, wherein said conduit is provided with an inflatable balloon member to facilitate the placement of said conduit within the pulmonary artery.

30. A method of performing beating heart surgery, comprising the step of maintaining at least partial blood flow through a protected blood flow path within a portion of at least one of the vena cava, the right atrium, the right ventricle and pulmonary artery of a beating heart, including the sub-steps of:

providing a generally coaxial cannula assembly having an inner conduit slideably disposed within an outer conduit;

introducing said generally coaxial cannula assembly into a human body such that a distal opening of said outer conduit is positioned in one of the vena cava, the right atrium, and right ventricle, and a distal opening of said inner conduit is positioned in the pulmonary artery, said inner conduit being slideably advanced through said outer conduit such that said inner conduit is positioned through the pulmonary valve and at least partially within the pulmonary artery to establish said protected blood flow path; and

pumping blood through said protected blood flow path by the action of a pump communicatively coupled between said outer and inner conduits, said pump transporting blood from at least one of the vena cava, the right atrium, and the right ventricle through the pulmonary valve and into the pulmonary artery.

31. The method of claim 30 and further, wherein said outer conduit is introduced into the right atrium through an aperture formed through the wall of the right atrium.

32. The method of claim 30 and further, wherein said inner conduit is provided with a curved distal portion to facilitate the placement of the inner conduit through the pulmonary valve and into the pulmonary artery.

33. A method of performing beating heart surgery, comprising the step of maintaining at least partial blood flow through a protected blood flow path within a portion of at least one of the left atrium, the left ventricle and aorta of a beating heart, wherein the step of maintaining at least partial blood flow involves the step of pumping blood through said protected blood flow path by the action of the beating heart.

34. The method of claim 33 and further, wherein said protected blood flow path is established by positioning a conduit at least partially within the aorta.

35. The method of claim 34 and further, wherein said conduit is provided extending through the aortic valve with a fluid inlet disposed in the left ventricle.

36. The method of claim 35 and further wherein said conduit is provided extending through the bicuspid valve into the left atrium with a fluid inlet disposed in the left atrium.

37. The method of claim 36 and further, wherein said conduit is provided with at least one valve for preventing the back flow of blood through at least one of the aortic valve and the bicuspid valve.

38. The method of claim 37 and further, wherein said conduit is introduced through the wall of the left atrium for passage into the left ventricle.

39. The method of claim 38 and further, wherein said conduit is provided with a blocking member disposed therein for preventing the flow of blood through the wall of the left atrium.

40. A method of performing beating heart surgery, comprising the step of maintaining at least partial blood flow through a protected blood flow path within a portion of at least one of the left atrium, the left ventricle and aorta of a beating heart, including the sub-steps of:

providing a generally coaxial cannula assembly having an inner conduit slideably disposed within an outer conduit;

introducing said generally coaxial cannula assembly into a human body such that a distal opening of said outer conduit is positioned in one of the left atrium and left ventricle, and a distal opening of said inner conduit is positioned in the aorta, said inner conduit being slideably advanced through said outer conduit such that said inner conduit is positioned through at least one of the aortic valve and the bicuspid valve to establish said protected blood flow path; and

pumping blood through said protected blood flow path by the action of a pump communicatively coupled between said outer and inner conduits, said pump transporting blood from at least one of the left atrium and the left ventricle through the aortic valve and into the aorta.

41. The method of claim 40 and further, wherein said outer conduit is introduced into the left atrium through an aperture formed in the wall of the left atrium.

42. A method of performing beating heart bypass surgery which comprises the steps of:

inserting the cannula portion of a pump and cannula system through the tricuspid valve, through the pulmonary valve and a sufficient length into the pulmonary artery to prevent collapse of the right atrium, right ventricle or pulmonary artery when the heart is stressed, lifted or displaced during surgery;

pumping blood from upstream of the pulmonary valve into the pulmonary artery to augment the flow of blood through the pulmonary valve produced by the beating heart; and

positioning the heart to provide surgical access to the lateral or posterior heart vessels during beating heart surgery.

43. The method of claim 42, wherein the step of positioning the heart to provide surgical access to the lateral or posterior vessels of the heart during beating heart surgery involves the further sub-step of supporting the heart during surgery.

44. The method of claim 43, wherein the sub-step of supporting the heart during surgery involves the further sub-step of providing a support member for supporting the heart to provide surgical access to the lateral or posterior vessels of the heart.

45. A method of performing beating heart bypass surgery which comprises:

positioning a first conduit through an incision in one of the wall of the vena cava or right atrium;

positioning a second conduit through an incision in the wall of the pulmonary artery;

providing a blood pump having a pump intake port and a pump outflow port;

connecting said pump intake port to said first conduit to remove blood from at least one of the right atrium and vena cava;

connecting said pump outflow port to said second conduit to deposit blood from said blood pump into the pulmonary artery; and

pumping blood from the right atrium or vena cava through the pump and into the pulmonary artery during beating heart surgery.

46. The method of claim 45, further comprising the step of supporting the heart during beating heart surgery to provide surgical access to the lateral or posterior heart vessels.

47. The method of claim 46, wherein the step of supporting the heart during surgery involves the further sub-step of providing a support member.

48. The method of claim 47, wherein the support member comprises a cradle assembly.