Intravascular electrophysiological system and methods

• US 20050043765A1
• Filed: 06/04/2004
• Published: 02/24/2005
• Est. Priority Date: 06/04/2003
• Status: Active Grant

• Current Assignee: Nuxcel2 LLC
• Original Assignee: Synecor LLC
• Inventors: Holbrook, Kevin, Williams, Michael S., Glenn, Richard A., Fifer, Daniel W., Ransbury, Terrance
• Granted Patent: US 7,529,589 B2
• Time in Patent Office: Days
• US Class Current: 607/9
• CPC Class Codes: A61N 1/057 Anchoring means; Means for fixing the head inside the heart
• CPC Class Codes: A61N 1/37205 Microstimulators, e.g. implantable through a cannula
• CPC Class Codes: A61N 1/37512 Pacemakers
• CPC Class Codes: A61N 1/37516 Intravascular implants
• CPC Class Codes: A61N 1/37518 Anchoring of the implants, e.g. fixation

Abstract

The present application describes an intravascular implantable pacing and/or defibrillation system. The described system includes a pulse generator that is implantable within a blood vessel and proportioned to blood flow through the blood vessel, and at least one electrode attachable to the pulse generator. During implantation, the pulse generator is introduced into a patient'"'"'s vasculature, advanced to a desired vessel and anchored in place within the vessel. The electrode or electrodes are placed within the heart or surrounding vessels as needed to deliver electrical pulses to the appropriate location.

Claims

1. A method of implanting an electrophysiological device, comprising the steps of:

introducing a pulse generator into the vasculature of a patient and advancing the pulse generator to a target vessel;

anchoring the pulse generator within the target vessel; and

positioning at least one electrode within the cardiovascular system, the electrode coupled to the pulse generator.

2. The method of claim 1, wherein the target vessel is a vein.

3. The method of claim 1, wherein the target vessel is an artery.

4. The method of claim 2, wherein the target vessel is the superior vena cava.

5. The method of claim 2, wherein the target vessel is the inferior vena cava.

6. The method of claim 1, wherein the positioning step includes positioning the electrode within a vessel.

7. The method of claim 6, wherein the vessel is a vein.

8. The method of claim 6, wherein the vessel is an artery.

9. The method of claim 7, wherein the vessel is the left subclavian.

10. The method of claim 7, wherein the vessel is the superior vena cava.

11. The method of claim 7, wherein the vessel is the inferior vena cava.

12. The method of claim 7, wherein the vessel is the middle cardiac vein.

13. The method of claim 7, wherein the vessel is selected from the group of vessels consisting of the pulmonary vein, hepatic vein, renal vein, axillary vein, lateral thoracic vein, internal thoracic vein and splenic vein.

14. The method of claim 1, wherein the positioning step includes positioning the electrode within a chamber of the heart.

15. The method of claim 14, wherein the chamber is the right ventricle.

16. The method of claim 14, wherein the chamber is the right or left atrium.

17. The method of claim 14, wherein the chamber is the left ventricle.

18. The method of claim 1, wherein the positioning step includes positioning the electrode within the coronary sinus of the heart.

19. The method of claim 1, wherein the electrode is a first electrode and wherein the method further includes positioning a second electrode within the cardiovascular system, the second electrode electrically coupled to the pulse generator.

20. The method of claim 19, wherein the positioning steps include positioning the first electrode within a vessel, and positioning the second electrode within a chamber of the heart.

21. The method of claim 19, wherein the positioning steps include positioning the first electrode within a chamber of the heart, and positioning the second electrode within another chamber of the heart.

22. The method of claim 19, wherein the positioning steps include positioning the first electrode within a vessel, and positioning the second electrode within a coronary sinus of the heart.

23. The method of claim 19, wherein the positioning steps include positioning the first and second electrodes within blood vessels.

24. The method of claim 23, wherein the first and second electrodes are positioned in separate blood vessels.

25. The method of claim 1, wherein the pulse generator is disposed in an elongate device body, wherein the electrode is on the device body, and wherein the introducing step includes the positioning step.

26. The method of claim 1, wherein the pulse generator is disposed in an elongate device body, wherein the at least one electrode is on a lead coupled to the device body, and wherein the positioning step includes positioning at least a portion of the lead within the cardiovascular system.

27. The method of claim 26, wherein the electrode is a first electrode and wherein the device body includes at least one second electrode.

28. The method of claim 25, wherein the electrode is a first electrode and wherein the device body includes at least one second electrode positioned on the device body at a location remote from the first electrode.

29. The method of claim 1, wherein the anchoring step placing an anchor in contact with the pulse generator and expanding an anchor into contact with a wall of the target vessel.

30. The method of claim 29, wherein the anchoring step includes positioning an anchor within the target vessel adjacent to the pulse generator, and expanding the anchor into contact with a wall of the target vessel such that expansion of the anchor engages the pulse generator between a portion of the anchor and the wall.

31. The method of claim 29, wherein the anchor substantially minimizes blood flow between the anchor and the device.

32. The method of claim 29, wherein the anchor is coupled to the pulse generator before the pulse generator is introduced into the target vessel.

33. The method of claim 29, wherein the anchor is introduced as a separate component from the pulse generator.

34. The method of claim 30, wherein the anchor includes a tubular member having end sections and an intermediate section between the end sections, and wherein the anchoring step includes positioning the intermediate section adjacent to the device, and radially expanding at least a portion of the end sections into contact with the vessel.

35. An intravascular electrophysiological system, comprising:

a pulse generator implantable within a blood vessel, the pulse generator proportioned to allow blood flow through the blood vessel; and

at least one electrode electrically coupled to the pulse generator.

36. The system of claim 35, wherein the pulse generator has a cross-sectional area or approximately 79 mm² or less, and more preferably in the range of approximately 40 mm² or less.

37. The system of claim 36, wherein the pulse generator has a cross-sectional area of approximately 40 mm² or less.

38. The system of claim 35, wherein the pulse generator includes at least one flexible region, the region sufficiently flexible to permit bending of the pulse generator during positioning of the pulse generator through a blood vessel.

39. The system of claim 38, wherein the pulse generator includes an elongate array of rigid segments, and flexible regions between adjacent rigid segments.

40. The system of claim 35, wherein:

the pulse generator includes a plurality of components including a battery, a capacitor, and electronic components;

the pulse generator includes a housing containing at least a portion of the components, and

the pulse generator further includes a ribbon coupled to the housing, the ribbon including at least a portion of the components.

41. The system of claim 40, wherein the ribbon includes the capacitor.

42. The system of claim 40, wherein the ribbon includes the battery.

43. The system of claim 35, further including an anchor expandable into contact with a vessel wall to retain the pulse generator within the vessel.

44. The system of claim 43, wherein the anchor is positionable within a vessel at a location adjacent to the pulse generator, and moveable to an expanded position to engage the pulse generator against the vessel wall.

45. The system of claim 43, wherein the anchor is integral with the pulse generator.

46. The system of claim 43, wherein the anchor is an expandable tubular member.

47. The system of claim 43, wherein the anchor is formed of a mesh framework.

48. The system of claim 43, wherein the anchor includes interstices for promoting tissue ingrowth.

49. The system of claim 43, wherein the anchor has a non-thrombogenic surface.

50. The system of claim 35, wherein the pulse generator includes an elongate device body and wherein at least one electrode is on the device body.

51. The system of claim 35, wherein the pulse generator includes an elongate device body and wherein at least one electrode is on a lead coupled to the device body.

52. The system of claim 51, wherein the at least one electrode is a first electrode, and wherein the system further includes at least one second electrode on the device body.

53. The system of claim 51, wherein the system is proportioned to allow positioning of the device body in a first blood vessel and positioning of the lead in a second blood vessel different from the first blood vessel.

54. The system of claim 50, wherein the at least one electrode is a first electrode on a first portion of the device body, and wherein the system further includes a second electrode on a second portion of the device body that is remote from the first electrode.

55. The system of claim 54, wherein in the device is proportioned to allow positioning of the first electrode in a first blood vessel and the second electrode in a second blood vessel different from the first blood vessel.

56. The system of claim 43, wherein the anchor is proportioned to allow blood flow through the vessel when used to engage the pulse generator against a vessel wall.

57. The system of claim 35, wherein the electrodes are carried by a lead, wherein the system further includes an anchor, the anchor positionable within a vessel at a location adjacent to the lead, and moveable to an expanded position to engage the lead against the vessel wall.

58. The system of claim 57, wherein the anchor is proportioned to allow blood flow through the vessel when used to engage the lead against a vessel wall.

59. The system of claim 35, wherein the pulse generator includes a non-thrombogenic surface.

60. The system of claim 35, wherein the at least one electrode is on a lead coupled to the pulse generator.

61. The system of claim 60, wherein the lead includes a non-thrombogenic surface.

62. The system of claim 35, wherein the pulse generator is a defibrillation pulse generator.

63. The system of claim 35, wherein the pulse generator is a pacing pulse generator.

64. A method for retaining a medical device within a blood vessel, comprising the steps of:

providing an expandable retention device and an intravascular medical device;

positioning the medical device in a blood vessel;

placing at least a portion of the retention device in contact with the medical device;

with the retention device in the compressed position, positioning the retention device in the blood vessel; and

expanding the retention device to the expanded position to retain the medical device within the vessel.

65. The method of claim 64, wherein the placing step includes coupling the medical device and the retention device prior to the positioning step.

66. The method of claim 64, wherein the placing step includes coupling the medical device and the retention device after the positioning step.

67. The method of claim 64, wherein the medical device and retention device are separated components, and wherein the placing and expanding steps include expanding the retention device into contact with the medical device within the vessel.

68. The method of claim 67, wherein the placing and expanding steps include:

with the retention device in the compressed position, positioning the retention device in the vessel adjacent to the medical device; and

expanding the retention device to the expanded position to engage the medical device between an exterior surface of the retention device and a surface of the vessel.

69. The method of claim 64, wherein the retention device is an expandable retention sleeve.

70. The method of claim 69, wherein the retention sleeve substantially minimizes blood flow between the retention sleeve and the medical device.

71. The method of claim 69, wherein the retention sleeve includes a tubular member having end sections and an intermediate section between the end sections, and wherein the method includes positioning the intermediate section adjacent to the device, and radially expanding at least a portion of the end sections into contact with the vessel.

72. The method of claim 64, wherein the method includes the step of positioning the retention device in the compressed position within a positioning sheath, and wherein the expanding step includes releasing the retention device from the positioning sheath.

73. The method of claim 72, wherein the expanding step includes causing the retention device to self-expand after being released from the positioning sheath.

74. The method of claim 64, wherein the expanding step includes positioning an expansion device within the retention device and expanding the expansion device.

75. The method of claim 74, wherein the expansion device is a balloon.

76. The method of claim 64, wherein the medical device is a pulse generator.

77. The method of claim 64, wherein the medical device is a lead.

78. The method of claim 64, further including the steps of positioning a liner within the vessel and positioning the medical device within the liner, and wherein the expanding step include expanding the retention device within the liner to engage the medical device between the retention device and the liner.

79. The method of claim 64, further including the step of promoting tissue growth into the structure of the retention device.

80. A retention device for retaining a medical device within a blood vessel, comprising:

an expandable member positionable in contact with an intravascular medical device and proportioned for receipt within a vessel, at least a portion of the expandable member expandable to radially engage a vessel wall and to thereby retain the medical device within the vessel.

81. The retention device of claim 80, wherein the expandable member is a radially expandable tubular member.

82. The retention device of claim 80, wherein the expandable member includes a coupling connected to an intravascular medical device.

83. The retention device of claim 82, wherein the coupling supports the medical device out of contact with the vessel wall.

84. The retention device of claim 82, wherein the coupling supports the medical device in contact with the vessel wall.

85. The retention device of claim 81, wherein the tubular member includes radially expandable end sections proportioned to radially engage a vessel wall.

86. The retention device of claim 81, wherein the tubular member includes end sections and a conformable intermediate section between the end sections.

87. The retention device of claim 80, wherein the expandable member includes a blood-impermeable barrier.

88. The retention device of claim 87, wherein the barrier includes a non-thrombogenic surface.

89. The retention device of claim 88, wherein the non-thrombogenic surface is configured to elute a non-thrombogenic or anti-platelet agent.

90. The retention device of claim 87, wherein the barrier includes an anti-proliferative surface.

91. The retention device of claim 90, wherein the anti-proliferative surface is configured to elute an anti-proliferative agent.

92. The retention device of claim 87, wherein the barrier includes a surface configured to elute an immunosupressive agent.

93. The retention device of claim 80, wherein at least a portion of the expandable member includes a structural framework.

94. The retention device of claim 80, further including a tubular vessel liner, wherein the tubular member is proportioned to be received within the vessel liner within a vessel, such that the retention device retains the medical device between the retention device and the liner.

95. The retention device of claim 80, wherein the expandable member includes interstices for promoting tissue ingrowth.

96. A method of delivering an electrical pulse to a heart, comprising the steps of:

positioning a first electrode within a blood vessel;

positioning a second electrode within the cardiovascular system; and

delivering an electrical pulse between the first and second electrodes.

97. The method of claim 96, wherein the blood vessel is an artery.

98. The method of claim 96, wherein the blood vessel is a vein.

99. The method of claim 98, wherein the blood vessel is a subclavian vein.

100. The method of claim 98, wherein the blood vessel is an inferior vena cava.

101. The method of claim 98, wherein the blood vessel is a superior vena cava.

102. The method of claim 96, wherein the step of positioning the second electrode includes positioning the second electrode in a blood vessel.

103. The method of claim 102, wherein the second electrode is positioned in an artery.

104. The method of claim 103, wherein the second electrode is positioned in a vein.

105. The method of claim 104, wherein the second electrode is positioned in a subclavian vein.

106. The method of claim 104, wherein the second electrode is positioned in an inferior vena cava.

107. The method of claim 104, wherein the second electrode is positioned in a superior vena cava.

108. The method of claim 104, wherein the second electrode is positioned in a middle cardiac vein.

109. The method of claim 104, wherein the second electrode is positioned in a vessel selected from the group of vessels consisting of the pulmonary vein, hepatic vein, renal vein, axillary vein, lateral thoracic vein, internal thoracic vein and splenic vein.

110. The method of claim 96, wherein the second electrode is positioned within a chamber of the heart.

111. The method of claim 110, wherein the chamber is the right ventricle.

112. The method of claim 110, wherein the chamber is the right atrium or left atrium.

113. The method of claim 110, wherein the chamber is the left ventricle.

114. The method of claim 96, wherein the second electrode is positioned within the coronary sinus of the heart.

115. The method of claim 96, wherein the pulse is a defibrillation pulse.

116. The method of claim 96, wherein the pulse is a cardioversion pulse.

117. The method of claim 96, wherein the pulse is a pacing pulse.

118. The method of claim 96, wherein the pulse is a cardiac resynchronization pulse.

119. The method of claim 96, wherein the pulse delivers approximately 0.1-50 joules of energy.

120. The method of claim 119, wherein the pulse delivers approximately 5-35 joules of energy.

121. An intravascular medical device, comprising:

an elongate device body proportioned for receipt within a blood vessel;

a power supply within the device body; and

circuit components within the device body and electrically coupled to the power supply.

122. The intravascular medical device of claim 121, wherein the elongate device body is comprised of a plurality of segments and hinge regions between the segments.

123. The intravascular medical device of claim 121, wherein the elongate medical device has a length of approximately 10-60 cm.

124. The intravascular medical device of claim 121, wherein the elongate medical device has a length of approximately 25-55 cm.

125. The intravascular medical device of claim 121, further including an implantation mandrel attachable to the device body.

126. The intravascular medical device of claim 121, further including an expandable retention device positionable in contact with the device body and expandable into engagement with a wall of a blood vessel.

127. The intravascular medical device of claim 121, wherein the retention device is attachable to the device body.

128. The intravascular medical device of claim 121, wherein the device body has a diameter of approximately 10 mm or less.

129. The intravascular medical device of claim 121, wherein the device body has a diameter of approximately 7 mm or less.

130. The system of claim 121, wherein the device body has a cross-sectional area or approximately 79 mm² or less, and more preferably in the range of approximately 40 mm² or less.

131. The system of claim 121, wherein the device body has a cross-sectional area of approximately 40 mm² or less.

132. The system of claim 121, wherein the medical device is an electrophysiological device.

133. The system of claim 121, wherein the medical device includes a reservoir containing a pharmaceutical or therapeutic agent.

134. The system of claim 133, further including at least one elongate tubule fluidly coupled with the reservoir and positionable within a blood vessel or organ for delivery of the agent thereto.