OBSTRUCTIVE SLEEP APNEA TREATMENT DEVICES, SYSTEMS AND METHODS

• US 20110202106A1
• Filed: 04/25/2011
• Published: 08/18/2011
• Est. Priority Date: 10/13/2006
• Status: Active Grant

• Current Assignee: LivaNova USA, Inc. (LivaNova Plc)
• Original Assignee: Apnex Medical, Inc.
• Inventors: Thorp, Christopher K., Kaplan, Paula M., Bolea, Stephen L., Hauschild, Sidney F., Atkinson, Robert E., Persson, Bruce J., Hoegh, Thomas B., Kuhnley, Brian D., Jasperson, Keith E., Tesfayesus, Wondimeneh
• Granted Patent: US 8,428,727 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

1-78. -78. (canceled)

79. A method of maintaining patency of an upper airway of a patient, the method comprising:

delivering an electrical stimulation to a portion of a superior laryngeal nerve via a nerve cuff when the nerve cuff is adjacent an external surface of the superior laryngeal nerve, the nerve cuff having a plurality of electrodes, wherein the nerve cuff is configured to be connected to an electrical stimulator via a stimulation lead.

80. The method of claim 79, further comprising:

sensing a biological parameter indicative of respiration; and

analyzing the sensed biological parameter to predict one of inspiration and expiration, wherein the electrical stimulation is delivered based on the predicted one of inspiration and expiration.

81. The method of claim 79, wherein the portion of the superior laryngeal nerve is an internal branch of the superior laryngeal nerve.

82. The method of claim 80, wherein the biological parameter is bio-impedance.

83. The method of claim 82, further comprising:

implanting an impedance sensor within the patient, wherein the impedance sensor is coupled to the electrical stimulator by a sensing lead.

84. The method of claim 79, further comprising:

delivering an electrical stimulation to one of a hypoglossal nerve and a glossopharyngeal nerve.

85. The method of claim 84, wherein the stimulation delivered to the portion of a superior laryngeal nerve is concurrently delivered with the stimulation to the one of a hypoglossal nerve and a glossopharyngeal nerve.

86. The method of claim 79, further comprising:

steering an electrical field of the nerve cuff to stimulate only afferent fibers of the portion of the superior laryngeal nerve.

87. The method of claim 79, wherein the step of delivering an electrical stimulation to a portion of a superior laryngeal nerve includes delivering the electrical stimulation to only afferent fibers of an internal branch of the superior laryngeal nerve.

88. The method of claim 79, wherein the stimulation lead includes a portion having a serpentine configuration.

89. The method of claim 88, wherein the stimulation lead includes a portion configured to be secured to a body structure other than a nerve.

90. The method of claim 79, wherein the plurality of electrodes are in direct contact with the portion of the superior laryngeal nerve.

91. A method of innervating a mechanoreceptor within a patient'"'"'s upper airway by stimulating a superior laryngeal nerve including both afferent and efferent fibers, the method comprising:

sensing a biological parameter indicative of respiration;

analyzing the sensed biological parameter to predict one of inspiration and expiration; and

delivering an electrical stimulation to the afferent fibers of an internal branch of the superior laryngeal nerve via a nerve cuff adjacent the internal branch of the superior laryngeal nerve, the nerve cuff including a plurality of electrodes.

93. The method of claim 91, further comprising:

steering an electrical field of the nerve cuff to stimulate only the afferent fibers of the internal branch of the superior laryngeal nerve.

94. The method of claim 91, wherein the biological parameter is bio-impedance.

95. The method of claim 91, wherein the plurality of electrodes are in direct contact with a surface of the internal branch of a superior laryngeal nerve.

92. The method of claim 92, further comprising:

delivering an electrical stimulation to one of a hypoglossal nerve and a glossopharyngeal nerve simultaneously with delivering the electrical stimulation to the afferent fibers of the internal branch of the superior laryngeal nerve.

96. A method of controlling patency of an upper airway of a patient, the method comprising:

sensing a parameter indicative of respiration with an electrode sensor, wherein the electrode sensor is coupled to sensing circuitry of an implantable electrical stimulator;

processing the parameter to predict one of inspiration and expiration; and

delivering an electrical stimulation to the glossopharyngeal nerve via a nerve cuff having a plurality of electrodes, wherein the nerve cuff is connected to the implantable electrical stimulator by a stimulation lead, and wherein a portion of the stimulation lead is configured to elongate in response to movement by the patient.

97. The method of claim 96, wherein the parameter includes bio-impedance.

98. The method of 96, wherein the stimulation lead further includes a portion configured to be secured to a body structure other than a nerve.

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

a base member extending from a first side wall to a second side wall and having a top wall and a bottom wall;

a first flange member extending from the first side wall;

a second flange member extending from the second side wall; and

a third flange member having a first end fixedly engaged to the first side wall adjacent the first flange member, wherein the third flange member extends over the top wall of the base member, the second flange member extends over the top wall of the base member, and the first flange member, the second flange member, and the third flange member define a lumen.

100. The expandable electrode cuff of claim 99, wherein the third flange member 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, wherein the third flange member is positioned a first distance above the top wall of the base member in the first position, and the third flange member is positioned a second distance smaller than the first distance above the top wall of the base member in the second position.

101. The expandable electrode cuff of claim 99, wherein the second flange member 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, wherein the second flange member is positioned a first distance above the top wall of the base member in the first position, and the second flange member is positioned a second distance, greater than the first distance, above the top wall of the base member in the second position.

102. The expandable electrode cuff of claim 99, wherein the second flange member has a first thickness at a first end of the second flange member and a second thickness, less than the first thickness, at a second end.

103. The expandable electrode cuff of claim 99, further comprising a portion configured for pulling one or both of the third flange member and the second flange member under a nerve during positioning of the expandable electrode cuff about the nerve.

104. 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 member extending from a first side wall to a second side wall and having a top wall and a bottom wall;

a first flange member extending from the first side wall; and

a second flange member extending from the second side wall, wherein the first and second flange members extend over the top wall of the base member to form a lumen.