Implantable heart assist system and method of applying same

• US 20020151761A1
• Filed: 02/15/2002
• Published: 10/17/2002
• Est. Priority Date: 10/09/1997
• Status: Active Grant

• Current Assignee: TC1 LLC (Abbott Laboratories Incorporated)
• Original Assignee: ORQIS Medical Corporation
• Inventors: Bolling, Steven F., Werner, Wolfgang, Beizai, Masoud, Pecor, Robert, Sirimanne, Laksen, Viole, Anthony, Kelly, Ryan, OʼLeary, Shawn
• Granted Patent: US 6,610,004 B2
• Time in Patent Office: Days
• US Class Current: 600/16
• CPC Class Codes: A61M 1/3621 Extra-corporeal blood circuits single-needle circuits A61M1/30
• CPC Class Codes: A61M 1/3655 Arterio-venous shunts or fistulae
• 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 25/007 Side holes, e.g. their profiles or arrangements; Provisions to keep side holes unblocked
• CPC Class Codes: A61M 60/117 for assisting the heart, e.g. transcutaneous or external ventricular assist devices
• 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 60/152 branching on and drawing blood from a blood vessel
• CPC Class Codes: A61M 60/165 implantable in, on, or around the heart
• 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 60/274 the inlet and outlet being the same, e.g. para-aortic counter-pulsation blood pumps
• CPC Class Codes: A61M 60/414 transmitted by a rotating cable, e.g. for blood pumps mounted on a catheter
• CPC Class Codes: A61M 60/422 the force acting on the blood contacting member being electromagnetic, e.g. using canned motor pumps
• CPC Class Codes: A61M 60/515 Regulation using real-time patient data
• CPC Class Codes: A61M 60/538 Regulation using real-time blood pump operational parameter data, e.g. motor current
• CPC Class Codes: A61M 60/857 Implantable blood tubes

Abstract

An extracardiac pumping for supplementing the circulation of blood, including the cardiac output, in a patient without any component thereof being connected to the patient'"'"'s heart, and methods of using same. One embodiment of the intravascular extracardiac system comprises a pump with inflow and outflow conduits that are sized and configured to be implantable intravascularly through a non-primary vessel, whereby it may positioned where desired within the patient'"'"'s vasculature. The system comprises a subcardiac pump that may be driven directly or electromagnetically from within or without the patient. The pump is configured to be operated continuously or in a pulsatile fashion, synchronous with the patient'"'"'s heart, thereby potentially reducing the afterload of the heart. In another embodiment, the system is positioned extracorporeally, with the inflow conduit and outflow conduit applied percutaneously to a non-primary vessel for circulating blood to and from the non-primary vessel or between the non-primary vessel and another blood vessel within the patient'"'"'s vasculature.

Claims

1. A method for supplementing the circulation of blood through a patient without connecting any component to the patient'"'"'s heart, the method comprising the steps of:

connecting a distal end of an inflow conduit of a rotary pump to a first blood vessel that is not a primary blood vessel with a conduit having an inner diameter no greater than about 25 millimeters using a minimally invasive surgical procedure to permit the flow of blood to the pump from the first blood vessel, said pump configured to pump blood at volumetric rates that are on average subcardiac, wherein the step of connecting the inflow conduit to the first blood vessel comprises using a cannula that projects into the first blood vessel so as to draw blood from a point downstream of the point of blood vessel penetration;

connecting a distal end of an outflow conduit of the pump to a second blood vessel that is not a primary blood vessel with a conduit having an inner diameter no greater than about 25 millimeters using a minimally invasive surgical procedure to permit the flow of blood away from the pump to the second blood vessel; and

operating said pump to perfuse blood through the patient'"'"'s circulatory system at volumetric rates that are on average subcardiac.

2. A method for supplementing the circulation of blood through a patient without connecting any component to the patient'"'"'s heart, the method comprising the steps of:

connecting a distal end of an inflow conduit of a rotary pump to a first blood vessel that is not a primary blood vessel with a conduit having an inner diameter no greater than about 25 millimeters using a minimally invasive surgical procedure to permit the flow of blood to the pump from the first blood vessel, said pump configured to pump blood at volumetric rates that are on average subcardiac;

connecting a distal end of an outflow conduit of the pump to a second blood vessel that is not a primary blood vessel with a conduit having an inner diameter no greater than about 25 millimeters using a minimally invasive surgical procedure to permit the flow of blood away from the pump to the second blood vessel, wherein the step of connecting the outflow conduit to the second blood vessel comprises using a cannula that projects into the second blood vessel so as to direct blood to a point upstream of the point of blood vessel penetration; and

operating said pump to perfuse blood through the patient'"'"'s circulatory system at volumetric rates that are on average subcardiac.

3. A method for supplementing the circulation of blood through the patient without connecting any component to the patient'"'"'s heart, the method comprising the steps of:

connecting a distal end of an inflow conduit of a rotary pump to a non-primary blood vessel via a cannula through a minimally invasive surgical procedure to permit the flow of blood to the pump, said rotary pump configured to pump blood at volumetric rates that are on average subcardiac;

contemporaneously connecting a distal end of an outflow conduit of the pump to the non-primary blood vessel via a cannula with a minimally invasive surgical procedure to permit the flow of blood away from the pump; and

operating said pump at subcardiac rates to perfuse blood through the patient'"'"'s circulatory system.

4. The method of claim 3, wherein the step of connecting the inflow conduit comprises connecting the inflow conduit to the non-primary vessel at a first position, and the step of connecting the outflow conduit comprises connecting the outflow conduit to the non-primary vessel at a second position downstream of the first position.

5. The method of claim 3, wherein the step of connecting the inflow conduit comprises connecting the inflow conduit to the non-primary vessel at a first position, and the step of connecting the outflow conduit comprises connecting the outflow conduit to the non-primary vessel at a second position upstream of the first position.

6. The method of claim 3, wherein the non-primary blood vessel is a vein.

7. The method of claim 3, wherein the non-primary blood vessel is a artery.

8. The method of claim 3, wherein the non-primary blood vessel is a femoral artery.

9. The method of claim 3, wherein the inflow conduit is connected so as to permit the flow of blood to the pump from the non-primary blood vessel.

10. The method of claim 9, wherein the step of connecting the inflow conduit comprises connecting the inflow conduit to the non-primary vessel at a first position, and the step of connecting the outflow conduit comprises connecting the outflow conduit to the non-primary vessel at a second position downstream of the first position.

11. The method of claim 9, wherein the step of connecting the inflow conduit comprises connecting the inflow conduit to the non-primary vessel at a first position, and the step of connecting the outflow conduit comprises connecting the outflow conduit to the non-primary vessel at a second position upstream of the first position.

12. The method of claim 3, wherein the inflow conduit is connected so as to permit the flow of blood to the pump from a second blood vessel.

13. The method of claim 12, wherein the step of connecting the inflow conduit comprises connecting the inflow conduit to the non-primary vessel at a first position, and the step of connecting the outflow conduit comprises connecting the outflow conduit to the non-primary vessel at a second position downstream of the first position.

14. The method of claim 12, wherein the step of connecting the inflow conduit comprises connecting the inflow conduit to the non-primary vessel at a first position, and the step of connecting the outflow conduit comprises connecting the outflow conduit to the non-primary vessel at a second position upstream of the first position.

15. The method of claim 3, wherein the outflow conduit is connected so as to permit the flow of blood away from the pump through the non-primary blood vessel.

16. The method of claim 15, wherein the step of connecting the inflow conduit comprises connecting the inflow conduit to the non-primary vessel at a first position, and the step of connecting the outflow conduit comprises connecting the outflow conduit to the non-primary vessel at a second position downstream of the first position.

17. The method of claim 15, wherein the step of connecting the inflow conduit comprises connecting the inflow conduit to the non-primary vessel at a first position, and the step of connecting the outflow conduit comprises connecting the outflow conduit to the non-primary vessel at a second position upstream of the first position.

18. The method of claim 3, wherein the outflow conduit is connected so as to permit the flow of blood away from the pump through the non-primary blood vessel to a second blood vessel.

19. The method of claim 18, wherein the step of connecting the inflow conduit comprises connecting the inflow conduit to the non-primary vessel at a first position, and the step of connecting the outflow conduit comprises connecting the outflow conduit to the non-primary vessel at a second position downstream of the first position.

20. The method of claim 18, wherein the step of connecting the inflow conduit comprises connecting the inflow conduit to the non-primary vessel at a first position, and the step of connecting the outflow conduit comprises connecting the outflow conduit to the non-primary vessel at a second position upstream of the first position.

21. An extracardiac pumping system for supplementing blood circulation through a patient without any component thereof being connected to the patient'"'"'s heart, the extracardiac system comprising:

a rotary pump configured to pump blood through the patient at subcardiac volumetric rates, said pump having an average flow rate that, during normal operation thereof, is substantially below that of the patient'"'"'s heart when healthy;

an inflow conduit comprising flexible tubing having an inner diameter that is less than 25 millimeters fluidly coupled to the pump to direct blood to the pump from a non-primary blood vessel; and

,

an outflow conduit comprising flexible tubing having an inner diameter that is less than 25 millimeters fluidly coupled to the pump to direct blood from the pump to the non-primary blood vessel;

whereby connection of the first ends of the inflow and outflow conduits to the blood vessel may be made subcutaneously to permit application of the connections in an minimally-invasive procedure.

22. An extracardiac pumping system for supplementing blood circulation through a patient without any component thereof being connected to the patient'"'"'s heart, the extracardiac system comprising:

a pulsatile pump configured to pump blood through the patient at subcardiac volumetric rates, said pump having an average flow rate that, during normal operation thereof, is substantially below that of the patient'"'"'s heart when healthy;

an inflow conduit comprising flexible tubing having an inner diameter that is less than 25 millimeters fluidly coupled to the pump to direct blood to the pump from a non-primary blood vessel; and

,

an outflow conduit comprising flexible tubing having an inner diameter that is less than 25 millimeters fluidly coupled to the pump to direct blood from the pump to the non-primary blood vessel;

whereby connection of the first ends of the inflow and outflow conduits to the blood vessel may be made subcutaneously to permit application of the connections in an minimally-invasive procedure.

24. The extracardiac pumping system of claim 23, wherein the impeller is helically shaped.

25. The extracardiac pumping system of claim 23, wherein the impeller is driven mechanically by a motor through a drive wire.

26. The extracardiac pumping system of claim 23, wherein the impeller is driven electromagnetically by a discrete electromagnetic drive.

27. The extracardiac pumping system of claim 26, wherein the electromagnetic drive is sized and configured to be implantable.

28. The extracardiac pumping system of claim 27, wherein the electromagnetic drive is sized and configured to be implantable within the patient'"'"'s vasculature.

23. An extracardiac pumping system for supplementing blood circulation through a patient without any component thereof being connected to the patient'"'"'s heart, the extracardiac system comprising:

a pump comprising an impeller configured to pump blood through the patient at subcardiac volumetric rates, said pump having an average flow rate that, during normal operation thereof, is substantially below that of the patient'"'"'s heart when healthy;

an inflow conduit comprising flexible tubing having an inner diameter that is less than 25 millimeters fluidly coupled to the pump to direct blood to the pump from a non-primary blood vessel; and

,

an outflow conduit comprising flexible tubing having an inner diameter that is less than 25 millimeters fluidly coupled to the pump to direct blood from the pump to the non-primary blood vessel;

whereby connection of the first ends of the inflow and outflow conduits to the blood vessel may be made subcutaneously to permit application of the connections in an minimally-invasive procedure.

29. An extracardiac pumping system for supplementing blood circulation through a patient without any component thereof being connected to the patient'"'"'s heart, the extracardiac system comprising:

a pump comprising a rotatable cable having means for directing blood axially along the cable, said pump configured to pump blood through the patient at subcardiac volumetric rates, said pump having an average flow rate that, during normal operation thereof, is substantially below that of the patient'"'"'s heart when healthy;

an inflow conduit comprising flexible tubing having an inner diameter that is less than 25 millimeters fluidly coupled to the pump to direct blood to the pump from a non-primary blood vessel; and

,

an outflow conduit comprising flexible tubing having an inner diameter that is less than 25 millimeters fluidly coupled to the pump to direct blood from the pump to the non-primary blood vessel;

whereby connection of the first ends of the inflow and outflow conduits to the blood vessel may be made subcutaneously to permit application of the connections in an minimally-invasive procedure.

30. An extracardiac pumping system for supplementing blood circulation through a patient without any component thereof being connected to the patient'"'"'s heart, the extracardiac system comprising:

a pump comprising an archemedes screw configured to pump blood through the patient at subcardiac volumetric rates, said pump having an average flow rate that, during normal operation thereof, is substantially below that of the patient'"'"'s heart when healthy;

an inflow conduit comprising flexible tubing having an inner diameter that is less than 25 millimeters fluidly coupled to the pump to direct blood to the pump from a non-primary blood vessel; and

,

an outflow conduit comprising flexible tubing having an inner diameter that is less than 25 millimeters fluidly coupled to the pump to direct blood from the pump to the non-primary blood vessel;

whereby connection of the first ends of the inflow and outflow conduits to the blood vessel may be made subcutaneously to permit application of the connections in an minimally-invasive procedure.

31. An extracardiac pumping system for supplementing blood circulation through a patient without any component thereof being connected to the patient'"'"'s heart, the extracardiac system comprising:

a pump comprising worm pump configured to pump blood through the patient at subcardiac volumetric rates, said pump having an average flow rate that, during normal operation thereof, is substantially below that of the patient'"'"'s heart when healthy;

an inflow conduit comprising flexible tubing having an inner diameter that is less than 25 millimeters fluidly coupled to the pump to direct blood to the pump from a non-primary blood vessel; and

,

an outflow conduit comprising flexible tubing having an inner diameter that is less than 25 millimeters fluidly coupled to the pump to direct blood from the pump to the non-primary blood vessel;

whereby connection of the first ends of the inflow and outflow conduits to the blood vessel may be made subcutaneously to permit application of the connections in an minimally-invasive procedure.

32. An intravascular extracardiac pumping system for supplementing blood circulation through a patient experiencing congestive heart failure without any component thereof being connected to the patient'"'"'s heart, the extracardiac system comprising:

a pump configured to pump blood through the patient at subcardiac volumetric rates, said pump having an average flow rate that, during normal operation thereof, is substantially below that of the patient'"'"'s heart when healthy, the pump configured to be positioned within the vasculature of a patient;

an inflow conduit fluidly coupled to the pump to direct blood to the pump, the inflow conduit configured to be positioned within the vasculature of the patient; and

, an outflow conduit fluidly coupled to the pump to direct blood away from the pump, the outflow conduit configured to be positioned within the vasculature of the patient;

whereby the pump and the inflow and outflow conduits is configured so as to be inserted subcutaneously into the vasculature in an minimally-invasive procedure.

33. The intravascular extracardiac pumping system of claim 32, wherein the pump is a rotary pump.

34. The intravascular extracardiac pumping system of claim 32, wherein the pump is configured to operate in pulsatile fashion.

35. The intravascular extracardiac pumping system of claim 32, wherein the pump comprises an impeller.

36. The intravascular extracardiac pumping system of claim 35, wherein the impeller is helically shaped.

37. The intravascular extracardiac pumping system of claim 32, wherein the pump comprises a rotatable cable having means for directing blood axially along the cable.

38. The intravascular extracardiac pumping system of claim 32, wherein the pump comprises an archemedes screw.

39. The intravascular extracardiac pumping system of claim 35, wherein the impeller is driven mechanically by a motor through a drive wire.

40. The intravascular extracardiac pumping system of claim 35, wherein the impeller is driven electromagnetically by a discrete electromagnetic drive.

41. The intravascular extracardiac pumping system of claim 40, wherein the electromagnetic drive is sized and configured to be implantable.

42. The intravascular extracardiac pumping system of claim 41, wherein the electromagnetic drive is sized and configured to be implantable within the patient'"'"'s vasculature.

43. The intravascular extracardiac pumping system of claim 32, further comprising an additional conduit positioned proximate the pump to provide an additional flow path to blood in the vasculature from a point upstream of the inflow conduit to a point downstream of the outflow conduit without passing through the pump.

44. The intravascular extracardiac pumping system of claim 32, further comprising an additional conduit positioned proximate the pump to provide an additional flow path to blood in the vasculature from a point upstream of an inflow to the pump to a point downstream of an outflow from the pump without passing through the pump.

45. The intravascular extracardiac pumping system of claim 32, further comprising a pump driving means.

46. The intravascular extracardiac pumping system of claim 45, wherein the pump driving means is sized and configured to be implantable.

47. The intravascular extracardiac pumping system of claim 46, wherein the pump driving means is sized and configured to be implantable within the vasculature of a patient.

48. The intravascular extracardiac pumping system of claim 45, wherein the pump driving means comprises a drive wire.

49. The intravascular extracardiac pumping system of claim 45, wherein the pump driving means further comprises a motor.

50. The intravascular extracardiac pumping system of claim 45, wherein the pump driving means comprises an electromagnetic drive.

51. An intravascular extracardiac pumping system for supplementing blood circulation through a patient experiencing congestive heart failure without any component thereof being connected to the patient'"'"'s heart, the extracardiac system comprising:

a means for pumping blood; and

a conduit that houses the pumping means and is configured to direct blood from a location upstream of the pumping means to a location downstream of the pumping means;

whereby the pumping means and the conduit are configured to be insertable into a non-primary vessel subcutaneously in an minimally-invasive procedure for positioning within the patient'"'"'s vasculature.

52. The intravascular extracardiac pumping system of claim 51, wherein the pumping means comprises a rotary pump.

53. The intravascular extracardiac pumping system of claim 51, wherein the pumping means is configured to operate in pulsatile fashion.

54. The intravascular extracardiac pumping system of claim 51, wherein the pumping means comprises an impeller.

55. The intravascular extracardiac pumping system of claim 54, wherein the impeller is helically shaped.

56. The intravascular extracardiac pumping system of claim 51, wherein the pumping means comprises a rotatable cable having means for directing blood axially along the cable.

57. The intravascular extracardiac pumping system of claim 51, wherein the pumping means comprises an archemedes screw.

58. The intravascular extracardiac pumping system of claim 54, wherein the impeller is driven mechanically by a motor through a drive wire.

59. The intravascular extracardiac pumping system of claim 54, wherein the impeller is driven electromagnetically by a discrete electromagnetic drive.

60. The intravascular extracardiac pumping system of claim 59, wherein the electromagnetic drive is sized and configured to be implantable.

61. The intravascular extracardiac pumping system of claim 60, wherein the electromagnetic drive is sized and configured to be implantable within the patient'"'"'s vasculature.

62. The intravascular extracardiac pumping system of claim 51, wherein the pumping means comprises a worm pump.

63. The intravascular extracardiac pumping system of claim 51, further comprising an additional conduit positioned proximate the pumping means to provide an additional flow path to blood in the vasculature from a point upstream of an inflow to the pumping means to a point downstream of an outflow from the pumping means without passing through the pump.

64. The intravascular extracardiac pumping system of claim 51 further comprising a second inlet conduit.

65. The intravascular extracardiac pumping system of claim 51 further comprising a second outlet conduit.

66. A method for supplementing the circulation of blood through a patient without connecting any component to the patient'"'"'s heart, the method comprising the steps of:

providing a parallel flow system comprising a means for pumping blood and a conduit that houses the pump means;

inserting the pump means and the conduit into the patient'"'"'s vasculature in a non-primary vessel subcutaneously in an minimally-invasive procedure;

positioning the parallel flow system within the vasculature; and

operating said pump means to direct blood through the conduit.

67. The method of claim 66, wherein the non-primary vessel is a vein.

68. The method of claim 66, wherein the non-primary vessel is a artery.

69. The method of claim 66, wherein the non-primary vessel is a femoral artery.

70. The method of claim 66, wherein the pumping means comprises a rotary pump.

71. The method of claim 66, wherein the pumping means is configured to operate in pulsatile fashion.

72. The method of claim 66, wherein the pumping means comprises an impeller.

73. The method of claim 72, wherein the impeller is helically shaped.

74. The method of claim 66, wherein the pumping means comprises a rotatable cable having means for directing blood axially along the cable.

75. The method of claim 66, wherein the pumping means comprises an archemedes screw.

76. The method of claim 72, wherein the impeller is driven mechanically by a motor through a drive wire.

77. The method of claim 72, wherein the impeller is driven electromagnetically by a discrete electromagnetic drive.

78. The method of claim 77, wherein the electromagnetic drive is sized and configured to be implantable.

79. The method of claim 78, wherein the electromagnetic drive is sized and configured to be implantable within the patient'"'"'s vasculature.

80. The method of claim 66, wherein the pumping means comprises a worn pump.

81. The method of claim 66, further providing the step of providing an additional conduit positioned proximate the pumping means to provide an additional flow path to blood in the vasculature from a point upstream of an inflow to the pumping means to a point downstream of an outflow from the pumping means without passing through the pump.

82. An extracardiac pumping system for supplementing blood circulation through a patient without any component thereof being connected to the patient'"'"'s heart, the extracardiac system comprising:

a pump configured to pump blood through the patient at subcardiac volumetric rates, said pump having an average flow rate that, during normal operation thereof, is substantially below that of the patient'"'"'s heart when healthy;

an inflow conduit comprising flexible tubing having an inner diameter that is less than 25 millimeters fluidly coupled to the pump to direct blood to the pump from a non-primary blood vessel; and

,

an outflow conduit comprising flexible tubing having an inner diameter that is less than 25 millimeters fluidly coupled to the pump to direct blood from the pump to the non-primary blood vessel;

whereby connection of the first ends of the inflow and outflow conduits to the blood vessel may be made subcutaneously to permit application of the connections in an minimally-invasive procedure.

83. A method of supplementing blood perfusion to reduce the load on a patient'"'"'s heart without the use of a blood oxygenator, the method comprising directing blood within the patient'"'"'s vasculature at subcardiac rates using an implantable pumping means applied via a minimally invasive extracardiac application by connection to at least one non-primary blood vessel.

84. An intravascular extracardiac blood perfusion system comprising a multilumen catheter sized and configured to be applied intrasvascularly through a non-primary vessel and a pumping means sized and configured to pump blood at subcardiac rates while residing in a first lumen of said multilumen catheter.