Intravascular electrophysiological system and methods

• US 20080077219A1
• Filed: 10/30/2007
• Published: 03/27/2008
• Est. Priority Date: 06/04/2003
• Status: Active Grant

• Current Assignee: Nuxcel2 LLC
• Original Assignee: Daniel Fifer, Kevin Holbrook, Michael Williams, Richard Glenn, Terrance Ransbury
• Inventors: Holbrook, Kevin, Ransbury, Terrance, Williams, Michael, Glenn, Richard, Fifer, Daniel
• Granted Patent: US 7,899,554 B2
• Time in Patent Office: Days
• US Class Current: 607/126
• 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

1-63. -63. (canceled)

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 immunosuppressive 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.

121-134. -134. (canceled)