OBSTRUCTIVE SLEEP APNEA TREATMENT DEVICES, SYSTEMS AND METHODS

• US 20110196445A1
• Filed: 04/26/2011
• Published: 08/11/2011
• Est. Priority Date: 10/13/2006
• Status: Active Grant

• Current Assignee: Cyberonics, Inc
• Original Assignee: Apnex Medical, Inc.
• Inventors: Bolea, Stephen L, Atkinson, Robert E., Persson, Bruce J., Mazar, Scott T., Hoegh, Thomas B.
• Granted Patent: US 8,311,645 B2
• Time in Patent Office: Days
• US Class Current: 607/42
• CPC Class Codes: A61B 5/0809 by impedance pneumography
• CPC Class Codes: A61B 5/4818 Sleep apnoea
• CPC Class Codes: A61B 5/7239 using differentiation including higher order derivatives
• CPC Class Codes: A61N 1/0556 Cuff electrodes
• CPC Class Codes: A61N 1/0558 Anchoring or fixation means therefor
• CPC Class Codes: A61N 1/3601 of respiratory organs
• CPC Class Codes: A61N 1/3606 adapted for a particular treatment
• CPC Class Codes: A61N 1/37229 Shape or location of the implanted or external antenna

Abstract

Devices, systems and methods for nerve stimulation for OSA therapy.

Claims

1-74. -74. (canceled)

75. A lead system comprising:

a cuff electrode;

a first lead portion extending from the cuff electrode and having a generally serpentine configuration;

a second lead portion having a generally serpentine configuration and having a length substantially greater than a length of the first lead portion;

a first anchor interposed between the first lead portion and the second lead portion and configured to be secured relative to a non-nerve body structure; and

a connector extending proximally from the second lead portion and configured to electrically connect to an implantable pulse generator,

wherein the first lead portion has a length substantially greater than a distance between a nerve, onto which the cuff electrode is attached, and the non-nerve body structure onto which the first anchor is secured such that at least a portion of the first lead portion retains the generally serpentine configuration.

76. The lead system of claim 75, wherein the generally serpentine configuration of the respective first and second lead portions comprises a generally sinusoidal pattern.

77. The lead system of claim 75, wherein the length of the first lead portion corresponds to an arcuate length that includes a length of a curved portion of the generally serpentine configuration.

78. The lead system of claim 75, wherein the cuff electrode comprises:

an elongate cuff body including;

a base portion; and

a pair of resilient arcuate-shaped flange members, each flange member including a proximal portion and a distal portion, wherein the base and the two flange members define a lumen and wherein one of the proximal and distal portions defines a substantially re-closable opening, and wherein both the flange members extend a length of the cuff body; and

a plurality of electrode elements embedded within the cuff body and spaced apart from each other along a length of the cuff body.

79. The lead system of claim 78, wherein each electrode element includes:

a first portion extending along an inner surface of at least one of the respective flange members to be exposed at the lumen, wherein the exposed first portion of the electrode element is located generally opposite the substantially re-closable opening of the cuff body; and

a second portion extending into the base and away from the first portion at an angle relative to the first portion.

80. The lead system of claim 78, wherein one of the pair of resilient arcuate-shaped flange members includes an extension configured to overlap and be in releasable contact with a portion of the other of the pair of resilient arcuate-shaped flange members.

81. The lead system of claim 80, wherein, in a fully engaged configuration of the electrode assembly, one of the pair of resilient arcuate-shaped flange members is movable relative to, and in releasable contact with, the other of the pair of resilient arcuate-shaped flange members such that at least a portion of the one of the pair of resilient arcuate-shaped flange members extends across and covers the substantially re-closable opening.

82. A method of delivering a lead assembly, the method comprising:

releasably securing a cuff electrode about a hypoglossal nerve, the cuff electrode extending from a lead assembly having a first lead portion with a generally serpentine configuration, an anchor, a second lead portion with a generally serpentine configuration, and a connector, wherein a length of the first lead portion is substantially greater than a distance between a hypoglossal nerve and a non-nerve body structure adjacent the hypoglossal nerve;

extending the first lead portion from the cuff electrode toward the non-nerve body structure;

securing the anchor to the non-nerve body structure adjacent the hypoglossal nerve while maintaining at least a portion of the first lead portion in a generally serpentine configuration as the first lead portion extends between the cuff electrode and the anchor; and

extending the second lead portion from the anchor toward an implantable pulse generator.

83. The method of claim 82, comprising:

arranging the generally serpentine configuration of the respective first and second lead portions to define a generally sinusoidal pattern.

84. The method of claim 82, wherein the second lead portion includes a length larger than a length of the first lead portion.

85. The method of claim 82, comprising:

arranging the secured cuff electrode and the anchor in substantially the same vertical plane such that a majority of the first lead extends generally perpendicular to the vertical plane.

86. An electrode assembly comprising:

an elongate cuff body including;

a base portion; and

a pair of resilient arcuate-shaped flange members, each of the pair of resilient arcuate-shaped flange members including a proximal portion and a distal portion, wherein the base portion and the pair of resilient arcuate-shaped flange members define a lumen having a substantially re-closable portion, and wherein both of the pair of resilient arcuate-shaped flange members extend a length of the cuff body; and

a plurality of electrode elements embedded within the cuff body and spaced apart from each other along the length of the cuff body.

87. The electrode assembly of claim 86, wherein each electrode element includes:

a first portion extending along an inner surface of at least one of the pair of resilient arcuate-shaped flange members to be exposed at the lumen, wherein the exposed first portion of the electrode element is located generally opposite the substantially re-closable opening of the cuff body; and

a second portion extending into the base and away from the first portion at an angle relative to the first portion.

88. The electrode assembly of claim 87, wherein the first portion of each electrode element includes an arcuate length of less than 180 degrees.

89. The electrode assembly of claim 87, wherein the generally arcuate shape of the first portion substantially matches a radius of curvature of the inner surface of one of the pair of resilient arcuate-shaped flange members, wherein the first portion includes a hook portion extending generally away from the inner surface of the one of the pair of resilient arcuate-shaped flange members, and wherein the hook portion defines a recess configured to secure the respective electrode element relative to the cuff body.

90. The electrode assembly of claim 86, wherein one of the pair of resilient arcuate-shaped flange members includes an extension configured to overlap and be in releasable contact with a portion of the other of the pair of resilient arcuate-shaped flange members.

91. The electrode assembly of claim 86, wherein, in a fully engaged configuration of the electrode assembly, one of the pair of resilient arcuate-shaped flange members is movable relative to, and in releasable contact with, the other of the pair of resilient arcuate-shaped flange members such that at least a portion of the one of the pair of resilient arcuate-shaped flange members extends across and covers the substantially re-closable opening.

92. The electrode assembly of claim 86, wherein a diameter of the lumen defined by the electrode cuff body is expandable, in response to an increasing diameter of a nerve in the lumen.

93. The electrode assembly of claim 87, wherein the inner surface of one of the pair of resilient arcuate-shaped flange members in the region of the first portion of the respective electrode elements is recessed relative to remaining portions of the inner surface of the one of the pair of resilient arcuate-shaped flange members.

94. An electrode assembly comprising:

an elongate cuff body including;

a base portion; and

a pair of resilient arcuate-shaped flange members, each of the pair of resilient arcuate-shaped flange members including a proximal portion and a distal portion, wherein the base and the pair of resilient arcuate-shaped flange members at least partially define a lumen and wherein the distal portions define an opening providing access to the lumen, and wherein both the flange members extend a length of the cuff body; and

a plurality of electrode elements at least partially embedded within the cuff body and spaced apart from each other along the length of the cuff body.

95. The electrode assembly of claim 94, wherein each electrode element includes:

a first portion extending along an inner surface of the respective flange members and arranged to be exposed at the lumen, wherein the exposed first portion is located generally opposite the opening of the cuff body; and

a second portion generally extending outward and away from a midpoint of the first portion into the base portion.

96. The electrode assembly of claim 95, wherein the second portion of the electrode elements comprises a generally U-shaped portion defining a recess between two spaced apart portions.

97. The electrode assembly of claim 96, wherein the cuff body comprises a protrusion that extends into the recess of the generally U-shaped portion to embed the second portion within the base portion of the cuff body, the protrusion being exposed at the lumen.

98. The electrode assembly of claim 94, wherein one of the pair of resilient arcuate-shaped flange members includes an extension configured to overlap and be in releasable contact with a portion of the other of the pair of resilient arcuate-shaped flange members.

99. The electrode assembly of claim 94, wherein, in a fully engaged configuration of the electrode assembly, one of the pair of resilient arcuate-shaped flange members is movable relative to, and in releasable contact with, the other of the pair of resilient arcuate-shaped flange members such that at least a portion of the one of the pair of resilient arcuate-shaped flange members extends across and covers the substantially re-closable opening.

100. The electrode assembly of claim 94, wherein a diameter of the lumen defined by the elongate cuff body is expandable, in response to an increasing diameter of a nerve in the lumen.

101. An expandable electrode cuff of an implantable stimulation system, comprising:

a base portion; and

a first flange member and a second flange member, each extending from the base portion, wherein the first and second flange members extend over the base portion to form a lumen.

102. The expandable electrode cuff of claim 101, wherein the electrode cuff is capable of transitioning between a first position and a second position, wherein the lumen has a first dimension in the first position and a second dimension larger than the first dimension in the second position.

103. The expandable electrode cuff of claim 101, wherein one of the first and second flange members is capable of transitioning between a first position, prior to positioning of the electrode cuff about a nerve, and a second position subsequent to the positioning of the electrode cuff about the nerve.

104. The expandable electrode cuff of claim 103, wherein both the first and second flange members are capable of transitioning between the first and second positions.

105. The expandable electrode cuff of claim 101, wherein the first flange member is capable of being advanced between a first position, corresponding to a first diameter of the lumen at initial positioning of the electrode cuff about a nerve, and a second position corresponding to a second diameter greater than the first diameter subsequent to the initial positioning of the electrode cuff about the nerve.

106. The expandable electrode cuff of claim 102, wherein the first and second dimensions are diameters.

107. The expandable electrode cuff of claim 101, further comprising an extension for pulling one or both of the first flange member and the second flange member under a nerve during positioning of the expandable electrode cuff about the nerve.

108. An implantable stimulation system, comprising:

an implantable pulse generator;

a stimulation lead having a lead body extending from a lead body proximal end to a lead body distal end;

a connector positioned at the lead body proximal end for electrically connecting the stimulation lead and the implantable pulse generator; and

an expandable electrode cuff positioned at the lead body distal end, the expandable electrode cuff comprising;

a base portion; and

a first flange member and a second flange member, each extending from the base portion, wherein the first and second flange members extend over the base portion to form a lumen.