Single or multiple nerve stimulation to treat sleep-disordered breathing

Abstract

To provide an apparatus and / or method for treating sleep-disordered breathing. [Solution] Apparatuses and / or methods for treating sleep-disordered breathing may include stimulation of mononeurons, polyneurons, and other tissues associated with upper airway patency.

Claims

1. A method of treatment for sleep-disordered breathing, A method comprising stimulating at least one upper airway patency-related tissue via at least one stimulating element.

2. The method according to claim 1, wherein the tissues associated with upper airway patency include the hypoglossal nerve.

3. The method according to claim 1, comprising positioning the at least one stimulating element on the hypoglossal nerve on a first side of the patient's body.

4. The method according to claim 1, wherein the upper airway patency-related tissue includes only the hypoglossal nerve.

5. The method according to claim 1, wherein the upper airway patency-related tissue includes a cervical nerve loop.

6. The method according to claim 5, wherein the cervical nerve loop includes the superior root of the cervical nerve loop and at least one of the branches extending from the superior root of the cervical nerve loop.

7. The method according to claim 1, wherein the upper airway patency-related tissue includes only the cervical nerve loop.

8. The method according to claim 1, comprising positioning the at least one stimulating element on a cervical nerve loop on a first side of the patient's body.

9. The method according to claim 8, wherein the cervical nerve loop comprises a plurality of distinct parts of the cervical nerve loop, and the at least one stimulating element comprises a plurality of stimulating elements, each having a distinct stimulating element in a stimulating relationship with each distinct part of the cervical nerve loop.

10. Stimulation of the aforementioned cervical nerve loop is positioned, Omohyoid muscle, The thyroid muscle, and The method according to claim 8, comprising causing stimulation of at least one of the sternohyoid muscles.

11. Stimulation of the aforementioned cervical nerve loop is positioned, The thyroid muscle, and The method according to claim 8, comprising causing stimulation of at least one of the sternohyoid muscles.

12. The method according to claim 8, wherein the cervical nerve loops include a first cervical nerve loop on a first side of the body and a second cervical nerve loop on an opposing second side of the body, and the stimulation includes stimulating both of the respective first and second cervical nerve loops.

13. The method according to claim 12, wherein stimulating both of the first and second cervical nerve loops comprises stimulating both of the first and second cervical nerve loops simultaneously.

14. The method according to claim 12, wherein stimulating both of the first and second cervical nerve loops comprises stimulating the first and second cervical nerve loops alternately.

15. The upper airway patency-related tissue includes the hypoglossal nerve, and the at least one stimulating element includes a first stimulating element. The method according to claim 1, comprising implanting the first stimulating element in such a stimulating relationship with the hypoglossal nerve.

16. The at least one upper airway patency-associated tissue includes a cervical-associated nerve loop, the at least one stimulating element further includes a second stimulating element, and The method according to claim 15, further comprising implanting the second stimulating element in the cervical nerve loop in a separate implantation procedure some time after the implantation of the first stimulating element.

17. The method according to claim 16, further comprising implanting the second stimulator when determining whether a patient exhibits symptomatic residual AHI despite treatment of the hypoglossal nerve via the first stimulator.

18. The implantation of the second stimulating element is The method according to claim 16, comprising implanting a second stimulating lead, on which the second stimulating element is supported, at a position extending between an implanted pulse generator and the position of the second stimulating element in the cervical nerve loop.

19. The method according to claim 18, wherein the second stimulating element is located on the distal portion of the first stimulating lead.

20. The method according to claim 19, comprising implanting the second stimulating lead between the position of the second stimulating element in the cervical nerve loop and the pulse generator, and connecting the proximal portion of the second stimulating lead to the pulse generator.

21. Implanting and extending the second stimulating lead from the position of the second stimulating element in the cervical nerve loop toward the port interface along the middle portion of the implanted first stimulating lead, and The method according to claim 19, comprising connecting the proximal portion of the second stimulating lead to the port interface of the first stimulating lead, thereby establishing electrical communication between the second stimulating lead and the pulse generator.

22. The method according to claim 18, wherein the second stimulating element includes a first microstimulator, and the first microstimulator communicates wirelessly with at least one of the first stimulating element and the pulse generator.

23. The first stimulating element includes a first micro-stimulating device, The at least one upper airway patency-associated tissue further includes a cervical-associated nerve loop, the at least one stimulating element further includes a second stimulating element, and The method according to claim 15, further comprising implanting the second stimulating element in the cervical nerve loop in a separate implantation procedure some time after the implantation of the first stimulating element.

24. The method according to claim 23, wherein the second stimulating element includes a second microstimulator.

25. The method according to claim 24, comprising adjusting the stimulation between the first stimulating element and the second stimulating element via the second microstimulating device which communicates with the first microstimulating device.

26. The method according to claim 23, wherein the second stimulating element is located on the distal portion of the second stimulating lead.

27. The second stimulating lead is implanted between the position of the second stimulating element in the cervical nerve loop and the implanted pulse generator, and The method according to claim 26, comprising connecting the proximal portion of the second stimulation lead to the pulse generator.

28. The upper airway patency-related tissue includes a cervical nerve loop, and the at least one stimulating element includes a first stimulating element. The method according to claim 1, comprising implanting the first stimulating element in such a stimulating relationship with the cervical nerve loop.

29. The at least one upper airway patency-related tissue includes the hypoglossal nerve, the at least one stimulating element includes a second stimulating element, and The method according to claim 28, further comprising implanting the second stimulating element in a separate implantation procedure some time after the implantation of the first stimulating element.

30. The method according to claim 29, further comprising implanting the second stimulator at the time of determining that a patient exhibits symptomatic residual AHI despite treatment of the cervical nerve loop via the first stimulator.

31. The above-mentioned at least one upper airway patency-related tissue includes a cervical-related nerve loop, and the above-mentioned at least one stimulating element further includes a second stimulating element, and implanting the second stimulating element is, The method according to claim 15, comprising performing a single implantation procedure, which includes implanting the first stimulating element into the hypoglossal nerve and implanting the second stimulating element into the cervical nerve loop.

32. The method according to claim 31, wherein performing the single implant procedure includes a single stimulating lead supporting the first stimulating element and the second stimulating element.

33. The method according to claim 32, wherein the single stimulating lead includes a proximal portion, a bifurcated distal portion including a first stimulating portion containing the first stimulating element, and a second stimulating portion containing the second stimulating element.

34. Implanting a first stimulating lead containing the first stimulating element to stimulate the cervical nerve loop, and The method according to claim 31, comprising implanting a second stimulating lead including the second stimulating element to stimulate the hypoglossal nerve.

35. To form a single access incision, Inserting both the first and second stimulation leads into and through the single access incision, The method according to claim 34, comprising implanting the first stimulating element on the first stimulating lead into the cervical nerve loop and implanting the second stimulating element on the second stimulating lead into the hypoglossal nerve.

36. To form at least one tunnel from the implant position of each of the first and second stimulating elements to the second implant position, The method according to claim 35, comprising implanting a pulse generator at the second implant location and connecting the first stimulation lead and the second stimulation lead to the pulse generator.

37. The aforementioned connection, Directional connection to multiple ports on the pulse generator, and The method of claim 36, comprising being carried out via at least one of the following: an indirect connection to a port interface connected to the pulse generator.

38. Implanting a single pulse generator, To form the first access incision and the second access incision, Inserting the first portion of the tunneling tool into the first access incision, and inserting the second portion of the tunneling tool into the second access incision, The method according to claim 37, comprising advancing the respective first and second portions of the tunneling tool to form first and second tunnels from the respective first and second access incisions to the implanted pulse generator.

39. The first stimulating lead is implanted in the first access incision, the first stimulating lead is advanced through the first tunnel, and a portion of the first stimulating lead is positioned for connection to the implanted pulse generator, and The method according to claim 38, comprising implanting the second stimulating lead into the second access incision, advancing the second stimulating lead through the second tunnel, and positioning a portion of the second stimulating lead for connection to the implanted pulse generator.

40. The at least one stimulating element includes a first stimulating element and a second stimulating element, Positioning the first stimulating element on a first side of the patient's body, and positioning the second stimulating element on a second, opposing side of the patient's body, The method according to claim 1, comprising at least one of positioning the first stimulating element on a first side of the patient's body and positioning the second stimulating element on the same first side of the patient's body at a distance from the first stimulating element.

41. The method according to claim 1, wherein the at least one stimulating element includes a first stimulating element and a second stimulating element, and the stimuli transmitted through the respective first and second stimulating elements are coordinated with each other.

42. The method according to claim 41, comprising applying the stimulus synchronized with the sensed respiratory phase information.

43. The method according to claim 41, comprising applying the stimulus without synchronizing with respiratory information.

44. The method according to claim 41, comprising positioning the first stimulating element on the first hypoglossal nerve on the first side of the patient's body, and positioning the second stimulating element on the second hypoglossal nerve on the second side of the patient's body.

45. The method according to claim 41, comprising positioning the first stimulating element on the first side of the patient's body in a first cervical nerve loop, and the second stimulating element on the second side of the patient's body in a second cervical nerve loop.

46. Positioning the first stimulating element on the first hypoglossal nerve on the first side of the patient's body, The method according to claim 41, further comprising positioning the second stimulating element on a first cervical-related nerve loop on a second opposing side of the patient's body.

47. Positioning the first stimulating element on the first hypoglossal nerve and the second stimulating element on the first cervical nerve loop on the first side surface of the patient's body, or The method according to claim 41, comprising at least one of positioning the first stimulating element on the second hypoglossal nerve and the second stimulating element on the second cervical nerve loop on the second side surface of the patient's body.

48. The at least one stimulating element includes at least one first stimulating element and at least one second stimulating element, and the method is Positioning the at least one first stimulating element on at least one of the first hypoglossal nerve on the first side of the patient's body and the second hypoglossal nerve on the opposing second side of the patient's body, The method according to claim 1, comprising positioning the at least one second stimulating element in at least one of a first cervical-related nerve loop on the first side of the patient's body and a second cervical-related nerve loop on the second side of the patient's body.

49. At least one upper airway patency-related tissue includes the hypoglossal nerve and the cervical nerve loop, and the at least one stimulating element includes a first stimulating element. The method according to claim 1, comprising positioning a first stimulating element on both the hypoglossal nerve and the cervical nerve loop on a first side of the patient's body.

50. The method according to claim 51, wherein the first stimulating element includes a cuff electrode for at least partially surrounding a portion of the first hypoglossal nerve and a portion of the first cervical nerve loop.

51. The method according to claim 51, wherein the first stimulating element includes at least one of a paddle electrode and an axial electrode array that co-expands with a portion of the first hypoglossal nerve and a portion of the first cervical nerve loop.

52. The method according to claim 51, wherein the first stimulating element includes a first cuff electrode that at least partially surrounds a portion of the first hypoglossal nerve and a second cuff electrode that at least partially surrounds a portion of the cervical nerve loop.

53. The at least one upper airway patency-related tissue includes a cervical nerve loop, and the at least one stimulating element includes a first stimulating element. The at least one stimulating element includes a second stimulating element, and This includes stimulating the diaphragmatic nerve via the second stimulating element, The method according to claim 1, wherein the stimulation of each of the first and second stimulating elements is adjusted to treat multiple types of sleep apnea.

54. The method according to claim 55, comprising applying the stimulus to both the left and right sides of the patient's body via at least one of the first and second stimulating elements.

55. The method according to claim 55, comprising applying the stimulus to only one of the left side and the opposite right side of the patient's body via at least one of the first and second stimulating elements.

56. The at least one stimulating element includes a third stimulating element, This includes stimulating the hypoglossal nerve via a third stimulating element, The method according to claim 55, wherein the stimulation of each of the first, second, and third stimulating elements is adjusted to treat multiple types of sleep apnea.

57. The method according to claim 55, comprising delivering at least the second stimulating element to a location adjacent to the diaphragmatic nerve via a vascular access.

58. The method according to claim 55, comprising positioning the single-electrode array interface, which includes each of the first and second stimulating elements, in close proximity to both the cervical nerve loop and the diaphragmatic nerve.

59. The method according to claim 1, comprising delivering the at least one stimulating element to a position within the vascular structure such that it is in a stimulating relationship with the upper airway patency-related tissue via the vascular structure.

60. The method according to claim 61, wherein at least one stimulating element includes a microstimulator.

61. The method according to claim 61, wherein the tissues associated with upper airway patency include the hypoglossal nerve.

62. The method according to claim 61, wherein the upper airway patency-related tissue includes a cervical nerve loop.

63. The method according to claim 64, wherein the vascular structure includes the anterior jugular vein.

64. The method according to claim 64, wherein the vascular structure includes at least one of the inferior thyroid vein, the middle thyroid vein, and the superior thyroid vein.

65. The method according to claim 64, wherein the vascular structure includes the lateral anterior jugular vein.

66. The aforementioned upper airway patency-related tissues, Glossopharyngeal nerve, Superior laryngeal nerve, Superior cervical ganglion, Chemoreceptors, Cervical nerve loops, and The method according to claim 61, comprising at least one of the hypoglossal nerves.

67. The at least one stimulating element, Omohyoid tendon, Digastric tendon, trachea, sternum, hyoid bone, clavicle, and The method according to claim 68, comprising fixing via at least one of the thyroid-related tissues.

68. The method according to claim 1, wherein the upper airway patency-related tissues include upper airway patency-related muscles.

69. The method according to claim 70, wherein the muscles associated with upper airway patency include the genioglossus muscle.

70. The method according to claim 70, comprising delivering the at least one stimulating element to a position within the vascular structure such that it is in a stimulating relationship with the upper airway patency-related muscles, via the vascular structure.

71. The method according to claim 72, wherein the at least one stimulating element includes a microstimulator.

72. The method according to claim 72, wherein the muscles associated with maintaining upper airway patency include the infrahyoid muscle.

73. The method according to claim 74, wherein the infrahyoid muscle includes at least one of the sternothyroid muscle and the sternohyoid muscle.

74. The method according to claim 74, wherein the infrahyoid muscle includes the sternothyroid muscle.

75. The at least one upper airway patency-related tissue includes a cervical nerve loop, The at least one stimulating element, Omohyoid tendon, Digastric tendon, trachea, sternum, hyoid bone, clavicle, and The method according to claim 1, comprising fixing via at least one of the thyroid-related tissues.

76. The aforementioned fixing Suture thread, Tether, Fork, and The method according to claim 77, comprising being carried out via at least one of the anchor elements having wings.

77. The method according to claim 77, comprising implanting the at least one stimulating element adjacent to and above the sternum via an implant access incision.

78. The upper airway patency-related tissues include upper airway patency-related muscles, and the method is The method according to claim 1, comprising delivering the at least one stimulating element percutaneously to a location that is in a stimulating relationship with the upper airway patency-related muscles.

79. The method according to claim 80, wherein the upper airway patency-related muscles include the sternothyroid muscle.

80. The method according to claim 80, comprising forming a percutaneous access point located between the hyoid bone and the sternum, and midway lateral to the midline.

81. The method according to claim 80, comprising monitoring nerves during transcutaneous delivery.

82. The method according to claim 83, comprising performing the monitoring via a nerve integrity monitor (NIM).

83. The at least one upper airway patency-related tissue includes a first upper airway patency-related tissue and a second upper airway patency-related tissue, To stimulate the first upper airway patency-related tissue, at least one stimulating element including a first microstimulator, The method according to claim 1, further comprising at least one of the at least one stimulating element, which includes a second microstimulator, for stimulating the second upper airway patency-related tissue.

84. The method according to claim 85, wherein the first upper airway patency-related tissue includes the hypoglossal nerve, and the second upper airway patency-related tissue includes the non-hypoglossal nerve.

85. The method according to claim 86, wherein the non-hypoglossal nerve includes a first portion of the cervical-related nerve loop.

86. The aforementioned non-hypoglossal nerve, Superior laryngeal nerve, and The method according to claim 86, comprising at least one of the glossopharyngeal nerves.

87. The method according to claim 86, wherein the non-hypoglossal nerve includes the superior laryngeal nerve and the glossopharyngeal nerve.

88. The aforementioned non-hypoglossal nerve, Chemoreceptors, and The method according to claim 86, comprising at least one of the superior cervical ganglia.

89. The method according to claim 85, wherein the first upper airway patent-related tissue includes a cervical-related nerve loop, and the second upper airway patent-related tissue includes a superior cervical ganglion.

90. The method according to claim 85, wherein the first upper airway patent-related tissue includes a cervical nerve loop, and the second upper airway patent-related tissue includes the hypoglossal nerve.

91. The aforementioned at least one upper airway patency-related tissue includes the hypoglossal nerve and the non-hypoglossal nerve, The method according to claim 1, wherein the at least one stimulating element includes a first stimulating element for stimulating the hypoglossal nerve and a second stimulating element for stimulating the non-hypoglossal nerve.

92. The aforementioned non-hypoglossal nerve, Cervical nerve traps, Glossopharyngeal nerve, Superior laryngeal nerve, Superior cervical ganglion, and The method according to claim 93, comprising at least one of the chemoreceptors.

93. The method according to each of the first and second stimulating elements on separate stimulating lead portions, as described in claim 93.

94. Each of the first and second stimulating elements is, Unipolar electrode configuration, The method according to claim 95, comprising at least one of the bipolar electrode configurations.

95. The method according to claim 95, wherein the first stimulating element includes a plurality of electrode configurations.

96. The method according to claim 97, wherein the non-hypoglossal nerve includes a cervical-related nerve loop.

97. The second stimulating element is Unipolar electrode configuration, and The method according to claim 98, comprising at least one of the guided bipolar configurations.

98. The aforementioned upper airway patency-related tissues include the cervical nerve loop, The method according to claim 1, comprising selectively stimulating a cervical nerve loop to selectively activate at least several muscle groups stimulated by the cervical nerve loop.

99. The method according to claim 100, comprising performing the selective stimulation via control.

100. The selective stimulation is performed by positioning at least one stimulating element adjacent to the cervical nerve loop so as to be in a stimulating relationship with respect to the target muscle group to be stimulated, wherein the target muscle group sternothyroid muscle group, The sternohyoid muscles, and The method according to claim 100, comprising at least one of the omohyoid muscles.

101. The method according to claim 100, comprising performing the selective stimulation by excluding from the stimulation at least one muscle group stimulated by the cervical nerve loop.

102. The method according to claim 103, comprising excluding the omohyoid muscle group.

103. The aforementioned upper airway patency-related tissues, The first cervical (C1) spinal nerve, The second cervical (C2) spinal nerve, and The method according to claim 1, comprising at least one of the third cervical (C3) spinal nerves.

104. The method according to claim 1, wherein the upper airway patency-related tissue includes a first cervical (C1) spinal nerve and a second cervical (C2) spinal nerve, both of which form the superior root of a cervical-related nerve loop.

105. The method according to claim 1, wherein the upper airway patency-related tissue includes a second cervical (C2) spinal nerve and a third cervical (C3) spinal nerve, both of which form the inferior roots of the cervical nerve loop.

106. The aforementioned upper airway patency-related tissues include the cervical nerve loop, The method according to claim 1, comprising applying the stimulus to the cervical-related nerve loop in accordance with the direction of activation of the anterior nerve fibers.

107. The aforementioned upper airway patency-related tissues include the cervical nerve loop, The method according to claim 1, comprising performing the stimulation according to at least one of a plurality of different target stimulation locations of the cervical nerve loop, wherein each different target stimulation location is for causing contraction of a plurality of different muscle groups, including the sternothyroid muscle and the sternohyoid muscle.

108. The method according to claim 109, wherein the plurality of different muscle groups include the omohyoid muscle.

109. The aforementioned at least one upper airway patency-related tissue, Superior cervical ganglion, Glossopharyngeal nerve, Superior laryngeal nerve, and The method according to claim 1, comprising at least one of the chemoreceptors.

110. The method according to claim 1, wherein the at least one upper airway patency-related tissue includes the glossopharyngeal nerve and the superior laryngeal nerve.

111. The method according to claim 112, comprising performing the stimulation in order to stimulate only the glossopharyngeal nerve and the superior laryngeal nerve.

112. The said at least one upper airway patency-related tissue further includes the hypoglossal nerve and the cervical nerve loop, The method according to claim 112, further comprising stimulating the glossopharyngeal nerve and the superior laryngeal nerve in addition to stimulating at least one of the hypoglossal nerve and the cervical nerve loop.

113. The method according to claim 1, comprising forming a single implant access incision adjacent to the cervical nerve loop.

114. The method according to claim 115, comprising directly implanting a cuff electrode that is stimulating to the cervical nerve loop through the single implant access incision.

115. To form a tunnel to a location close to the hypoglossal nerve through the single implant access incision, and The method according to claim 116, comprising introducing and advancing a stimulating lead to position an axial electrode array stimulating to the hypoglossal nerve through the single implant access incision and through the tunnel.

116. The method according to claim 117, comprising implanting at least one of a microstimulator and an IPG through the single implant access incision.

117. The method according to claim 115, wherein the single implant access incision includes the sole implant access incision within the patient's body for implanting one of the cuff electrodes, the axial electrode array, and the microstimulator and the IPG.

118. The method according to claim 1, comprising sensing at least one sleep-disordered breathing-related parameter via at least one sensing element.

119. The at least one sleep-disordered breathing-related parameter includes at least one of the following: respiratory phase parameter, sleep apnea index, patient comfort parameter, arousal index, and upper airway collapse pattern. The method according to claim 120, wherein the stimulation is adjusted based on at least one of the respiratory phase parameters, sleep apnea index, patient comfort parameters, patient sleeping position, and upper airway collapse pattern.

120. The method according to claim 121, comprising synchronizing the stimulus with the sensed respiratory phase parameter.

121. The method according to claim 121, comprising automatically titrating a stimulation parameter based on sensing at least one of the respiratory phase parameter, the AHI parameter, the patient comfort parameter, the patient's sleeping position, and the upper airway collapse pattern.

122. Detecting the aforementioned upper airway collapse pattern The method according to claim 123, comprising determining the upper airway collapse pattern by sensing bioelectrical impedance to the cervical region of the patient's body.

123. Determining the upper airway collapse pattern involves identifying the type of the upper airway collapse pattern by identifying at least one of the sensed bioimpedance values, changes in values, and locations along the upper airway, and The method according to claim 124, comprising performing the automatic titration of the stimulation parameter based on the identified value, the change in the identified value, or the identified position.

124. The type of upper airway collapse pattern is, concentric, Lateral direction, Front - Back, and The method according to claim 125, which may include at least one of the composites.

125. The method according to claim 124, comprising performing the sensing via an array of spaced electrodes that are implantable and removable to insert.

126. The method according to the claim, comprising performing the sensing via an array of spaced electrodes that are externally detachable and adaptable to the external portion of the neck.

127. Based on the sensed respiratory phase parameter information, and, At least one of the following: amplitude of the stimulus, frequency, pulse width, and change in the load cycle, The method according to claim 123, comprising performing the automated titration of the stimulation parameter as at least one of the selection of at least one stimulation target from among a plurality of stimulation targets, including the hypoglossal nerve and the cervical nerve loop.

128. The method according to claim 129, wherein the plurality of stimulation targets include the glossopharyngeal nerve, the superior laryngeal nerve, the superior cervical ganglion nerve, and chemoreceptors.

129. Accepting patient adjustments to the stimulation parameters as a single input, and The method according to claim 129, comprising performing the patient adjustment by automatically adjusting the stimulation energy between a plurality of stimulation sites, including at least one of a hypoglossal nerve site, a cervical nerve loop site, and a second non-hypoglossal nerve site.

130. The method according to claim 131, wherein the stimulation is automatically balanced between the different stimulation sites.

131. The aforementioned automatic balance adjustment is To initiate and maintain the stimulation via stimulation of the first stimulation site of each of the aforementioned stimulation sites, and The method according to claim 132, further comprising, at a later point, stimulating each of the second stimulation sites of at least one of the plurality of stimulation sites.

132. The method according to claim 132, comprising performing the automatic balance adjustment based on sensing at least one of the respiratory phase parameters, AHI, patient comfort parameters, patient sleeping position, and upper airway collapse pattern.

133. The method according to claim 133, wherein the first stimulation site of each of the aforementioned stimulation sites includes the hypoglossal nerve, and the second stimulation site of each of the aforementioned stimulation sites includes the cervical nerve loop.

134. The method according to claim 133, wherein the first stimulation site among the respective stimulation sites includes a cervical nerve loop, and the second stimulation site includes the hypoglossal nerve.

135. The method according to claim 121, wherein the patient comfort parameter includes an arousal index.

136. Acceptance of patient adjustments to stimulation parameters in response to changes in the aforementioned patient comfort parameters, wherein the stimulation parameters include overall stimulation energy, and The method according to claim 121, comprising performing the patient adjustment by redistributing the overall stimulation energy among the increased stimulation sites.

137. The method according to claim 138, while maintaining the same overall energy as before the patient adjustment.

138. The method according to claim 138, wherein the patient adjustment includes a single input parameter.

139. The method according to claim 139, wherein patient adjustment includes a request for reduced stimulation.

140. The system includes automatically adjusting at least one of the stimulation parameters and the target stimulation location in the upper airway patency-related tissues upon sensing a change in the AHI parameter, The method according to claim 121, wherein the target stimulation location includes at least one of the hypoglossal nerve and the cervical nerve loop.

141. The method according to claim 142, wherein the detection of the increase in the AHI parameter is performed.

142. The method according to claim 142, comprising adjusting the stimulation parameter related to the cervical nerve trap when it is determined that the perceived change in the AHI parameter is associated with a change in the patient's sleeping position.

143. The method according to claim 144, wherein adjusting the change in the stimulus parameter includes increasing the stimulus parameter when the perceived change in the AHI parameter includes a perceived increase in the AHI parameter.

144. The method according to claim 120, wherein the at least one sensing element includes a first sensing element and a second sensing element.

145. Positioning the first sensing element on a first side of the patient's body, and positioning the second sensing element on a second, opposing side of the patient's body, The method according to claim 146, comprising at least one of positioning the first sensing element on a first side of the patient's body and positioning the second sensing element on the same first side of the patient's body at a distance from the first sensing element.

146. The method according to claim 147, wherein the sensing includes sensing the impedance between the respective first and second sensing elements.

147. The method according to claim 148, wherein the sleep-disordered breathing-related parameter includes at least one of respiration and sleep-disordered breathing events.

148. The method according to claim 148, wherein each of the first and second sensing elements includes a first stimulating element and a second stimulating element, respectively.

149. The method according to claim 150, comprising positioning the first stimulating element on the first hypoglossal nerve on the first side of the patient's body, and the second stimulating element on the second hypoglossal nerve on the second side of the patient's body.

150. The method according to claim 150, comprising positioning the first stimulating element on the first cervical nerve loop on the first side of the patient's body, and the second stimulating element on the second cervical nerve loop on the second side of the patient's body.

151. Position the first stimulating element on the first side of the patient's body, at least one of the first hypoglossal nerve and the first cervical nerve loop, and The method according to claim 150, comprising positioning the second stimulating element on the second side of the patient's body at least one of the second hypoglossal nerve and the second cervical nerve loop.

152. Positioning the first stimulating element on the first side of the patient's body, on the first hypoglossal nerve, and positioning the second stimulating element on the first side of the patient's body, on the first cervical nerve loop, or The method according to claim 150, comprising at least one of the following: positioning the second stimulating element on the second side of the patient's body, on the second hypoglossal nerve; and positioning the second stimulating element on the second side of the patient's body, on the second cervical nerve loop.

153. The method according to claim 148, wherein the first sensing element includes a first stimulating element, and the second sensing element includes an electrode on the housing of a pulse generator.

154. The first stimulating element is At least one of the first hypoglossal nerve on the first side of the patient's body and the second hypoglossal nerve on the second, opposite side of the patient's body, The method according to claim 155, comprising positioning at least one of the first cervical-related nerve loop on the first side of the patient's body and at least one of the second cervical-related nerve loop on the second side of the patient's body.

155. The at least one sensing element includes a first sensing element and a second sensing element, The method according to claim 120, comprising measuring the bioelectrical impedance between the first sensing element implanted in at least one upper airway patency-related tissue and the second sensing element implanted in at least one of the diaphragmatic nerve and the diaphragm.

156. The method according to claim 156, wherein the first sensing element includes a first stimulating element, and the second sensing element includes a second stimulating element.

157. The method according to claim 120, wherein the at least one upper airway patency-related tissue includes an upper airway patency-related muscle, and the sensing includes sensing at least one of the movement of the upper airway patency-related muscle and the EMG of the upper airway patency-related muscle.

158. Through at least one of the sensed motion and the sensed EMG, Titration of the amplitude of the stimulus signal applied via the at least one stimulating element, and The method of claim 158, comprising performing at least one of: determining the sufficiency of capturing the upper airway patency-related tissue stimulated via the stimulating element.

159. Through at least one sensing element, The movement of the upper airway patency-related muscles of at least one upper airway patency-related tissue, and The method according to claim 120, comprising determining the at least one sleep-disordered breathing-related parameter as a respiratory parameter by sensing at least one of the respiratory sounds associated with the at least one upper airway patency-related tissue.

160. The method according to claim 1, comprising forming a single implant access incision adjacent to the hypoglossal nerve.

161. The method according to claim 161, comprising directly implanting a cuff electrode that is in a stimulating relationship with the hypoglossal nerve through the single implant access incision.

162. To form a tunnel to a location close to the cervical nerve loop through the single implant access incision, and The method according to claim 162, comprising introducing and advancing a stimulating lead to position an axial electrode array stimulating to the cervical nerve loop through the single implant access incision and through the tunnel.

163. The method according to claim 163, comprising implanting at least one of a microstimulator and an IPG through the single implant access incision.

164. The method according to claim 115, wherein the single implant access incision includes the sole implant access incision within the patient's body for implanting one of the cuff electrodes, the axial electrode array, and the microstimulator and the IPG.

165. The method according to claim 1, wherein the upper airway patency-related tissue includes a cervical nerve loop.

166. The method according to claim 166, wherein the upper airway patency-related tissue further includes the superior cervical ganglion.

167. The method according to claim 166, wherein the at least one upper airway patency-related tissue further includes the hypoglossal nerve.

168. The method according to claim 168, comprising applying a first loading cycle of stimulation to the hypoglossal nerve in a manner different from a second loading cycle of stimulation for application to the cervical nerve loop.

169. The method according to claim 169, comprising performing the stimulation of the cervical-related nerve loop in order to stimulate at least one of the sternothyroid muscle and the sternohyoid muscle.

170. The method according to claim 169, wherein the first load cycle is faster than the second load cycle.

171. The method according to claim 169, wherein the first load cycle is slower than the second load cycle.

172. Applying the stimulus to the hypoglossal nerve as a phase stimulus, and The method according to claim 169, comprising applying the stimulus to the cervical nerve loop as a tonic stimulus.

173. The method according to claim 173, wherein the tonic stimulation includes a stimulation cycle in which the stimulation period is longer than the non-stimulation period.

174. The at least one upper airway patency-related tissue includes the hypoglossal nerve, Cervical nerve loops, and The method according to claim 1, comprising a second upper airway patency-related tissue, which includes at least one of the infrahyoid muscles.

175. The method according to claim 175, comprising simultaneously stimulating the hypoglossal nerve and the second upper airway patency-related tissue.

176. The method according to claim 176, comprising performing the stimulation by interleaving a first stimulus signal to stimulate the hypoglossal nerve and interleaving a second stimulus signal to stimulate the second upper airway patency-related tissue.

177. The method according to claim 176, comprising performing both the first and second stimulus signals via a single pulse generator.

178. The method according to claim 176, comprising performing the interleaving by applying the stimulation via a first frequency to the hypoglossal nerve and a different second frequency to the second upper airway patency-associated tissue.

179. The method according to claim 176, comprising performing the simultaneous stimulation via a time shift.

180. The method according to claim 176, comprising performing the simultaneous stimulation synchronously.

181. The method according to claim 175, comprising stimulating the hypoglossal nerve and then stimulating the second upper airway patency-related tissue to perform the stimulation.

182. The method according to claim 182, comprising maintaining the stimulation of the hypoglossal nerve during stimulation of the second upper airway patency-related tissue.

183. The method according to claim 183, wherein the cervical nerve loop includes at least a portion of the nerves that stimulate the sternothyroid muscles.

184. The aforementioned stimulus, Continuous stimulation at low frequencies, and The method according to claim 1, comprising performing at least one of a discontinuous stimulus including an on period and an off period, which causes muscle contraction.

185. The method includes performing the stimulation by selecting a stimulation target from among the different muscle groups associated with the hypoglossal nerve and the second upper airway patency-related tissues, based on the determination of a first parameter, Respiratory parameters including respiratory phase information, Patient comfort parameters, Posture parameters, Treatment effectiveness parameters, Device usage parameters, Sleep stage parameters, Upper airway collapse pattern parameters, and The method according to claim 175, comprising at least one of the sleep apnea index (AHI) parameters.

186. via accelerometer, The respiratory parameters including respiratory phase information, The aforementioned posture, The aforementioned treatment efficacy parameters, The aforementioned sleep apnea index (AHI) parameters, and The method according to claim 186, comprising performing the determination of at least one of the sleep stage parameters.

187. At least the following: acceleration, Bioelectrical impedance, pressure, Respiratory airflow, The method according to claim 187, comprising performing a determination of sleep stages by sensing via one of the modalities of a thermistor.

188. At least the following: breathing, posture, body position, Physical activity, and The method of claim 188, comprising performing the sensing by employing at least one of the modalities in order to sense one of the cardiac information.

189. The method according to claim 186, comprising making a determination of patient comfort through at least one of patient feedback and / or clinician feedback.

190. The method according to claim 186, comprising performing the selection of a stimulation target from among the different muscle groups associated with the hypoglossal nerve and the cervical nerve Wanna loop, via clinical titration, according to the first parameter.

191. The method according to claim 186, comprising performing the selection of at least one stimulation target from among different muscle groups associated with the hypoglossal nerve and the cervical nerve loop, according to the first parameter, by applying a data model.

192. The method of claim 192, comprising constructing the data model via known inputs corresponding to all of the stimulus targets to known outputs corresponding to the first parameter during a first period prior to performing the selection of at least one stimulus target.

193. The method according to claim 192, wherein the constructed data model includes a trained data model which optionally includes a trained machine learning model.

194. The method according to claim 194, wherein the trained machine learning model includes at least one of an artificial neural network, a deep learning model, and a support vector machine.

195. The method according to claim 192, wherein the first period includes a non-treatment period for the patient.

196. The aforementioned at least one upper airway patency-related tissue, Hypoglossal nerve, Cervical nerve loops, and The method according to claim 175, comprising a plurality of stimulation targets, including the infrahyoid muscle.

197. The method according to claim 197, comprising applying the stimulus to each stimulus target via an increased gradient stimulus signal to determine the relative degree of upper airway patency in each stimulus target.

198. The method according to claim 198, comprising applying the stimulus to at least two of the respective stimulus targets simultaneously.

199. The method according to claim 197, comprising selecting one of the respective stimulation targets to stimulate based on an upper airway collapse pattern.

200. The type and severity of the aforementioned upper airway collapse pattern are as follows: snore, Multiple polysomnography (PSG) parameters, body position, Head and neck position, and The method according to claim 200, comprising classifying based on at least one of the sleep stages.

201. The method according to claim 200, comprising selecting the stimulation target based on the type and severity of the upper airway collapse pattern.

202. When the upper airway collapse pattern is primarily a lateral wall collapse pattern, the stimulus target is selected as the first part of the cervical nerve loop. When the aforementioned upper airway collapse pattern is primarily a genioglossal muscle collapse pattern, the hypoglossal nerve is selected as the stimulation target, and The method according to claim 202, further comprising selecting a cervical nerve loop stimulation target as a first stimulation target before other stimulation targets, when the upper airway collapse pattern is primarily a palatal collapse pattern.

203. At least the following: Each of the different collapse patterns, The method according to claim 202, comprising titrating at least one stimulation parameter of the stimulation for one of the sleep positions.

204. The at least one of the aforementioned stimulation parameters is amplitude, pulse width, frequency, Load cycle, and The method according to claim 204, comprising at least one of the number, type, and position of stimulating elements.

205. The method according to claim 175, wherein the at least one upper airway patency-related tissue includes a plurality of muscle stimulation targets, including the genioglossus muscle, the sternohyoid muscle, the sternothyroid muscle, and the omohyoid muscle.

206. The method according to claim 206, further comprising performing the stimulus by distributing the energy of the stimulus signal among the selectable plurality of stimulus targets as the energy of the stimulus signal increases.

207. The method according to claim 207, comprising performing the stimulation of the muscle target by directly stimulating each of the muscle target described above.

208. The method according to claim 207, comprising stimulating the nerves that are to be stimulated by each of the muscle stimulation targets.

209. Before the completion of chronic implantation of the sleep-disordered breathing therapy system, A method comprising stimulating at least one test stimulation site that exhibits a response of upper airway patency-related tissue to the stimulus via a first stimulating element.

210. The method according to claim 210, wherein the pre-completion stage includes at least one of pre-operative and intra-operative stages.

211. The method according to claim 210, wherein the first stimulating element includes a test stimulating element.

212. The method according to claim 210, wherein the first stimulating element includes a stimulating element that can be chronically implanted.

213. The method according to claim 210, wherein the test stimulation location corresponds to a target stimulation location for implanting a chronically implantable stimulator.

214. The method according to claim 214, comprising performing the stimulation at the at least one test stimulation site, which includes the hypoglossal nerve and at least one non-hypoglossal nerve including at least the cervical nerve loop, via the first stimulating element.

215. To stimulate the hypoglossal nerve and determine the first response of upper airway patency to the stimulation, and The method according to claim 215, comprising stimulating the non-hypoglossal nerve after determining the first response, and determining a second response of upper airway patency to the stimulation.

216. The method according to claim 216, comprising maintaining the stimulation of the hypoglossal nerve during the stimulation of the non-hypoglossal nerve.

217. To stimulate the cervical nerve loop and determine a third upper airway patency response to the stimulation, and The method according to claim 215, further comprising determining the third response, stimulating the hypoglossal nerve, and determining a fourth response of upper airway patency to the stimulation.

218. The method according to claim 218, comprising maintaining the stimulation of the cervical nerve loop during the stimulation of the hypoglossal nerve.

219. The method according to claim 210, wherein the test stimulation location corresponds to a first location where the implantation of a chronically implantable stimulator is not intended.

220. The method according to claim 220, wherein the first position corresponds to an external position under the tongue.

221. The method according to claim 210, comprising determining the response of the upper airway patency-related tissues to the stimulus.

222. The method of claim 222, comprising performing the decision by observing the response.

223. Observing the aforementioned response To image at least one of the above-mentioned upper airway patency and the response of the above-mentioned upper airway patency-related muscles, and The method according to claim 223, comprising evaluating the relative patency and / or the response of the upper airway patency-related muscles.

224. The method according to claim 210, wherein the first stimulating element includes a test needle, and performing the stimulation includes percutaneously inserting the test needle into the cervical nerve loop and determining the upper airway response based on the stimulation.

225. The method according to claim 225, wherein determining the response includes performing the identification by identifying the downward movement of the larynx, measuring the EMG response of the larynx during the stimulation, and imaging the larynx.

226. This involves identifying patterns of upper airway collapse. In relation to sensing the upper airway, by arranging an array of electrodes including at least two spaced electrodes, and A method for identifying the size of the upper airway patency, including by measuring the bioelectrical impedance between at least two spaced electrodes.

227. The method according to claim 227, comprising positioning at least some of the electrodes of the array in a sensing relationship to an upper airway muscle stimulated by at least one of the cervical nerve loops and the hypoglossal nerve.

228. The method according to claim 228, wherein the positioning includes removably inserting the electrode array into the upper airway of the patient's body.

229. The method according to claim 228, wherein the positioning includes arranging the electrodes of the array in proximity to the upper airway and outside the patient's body.

230. The method according to claim 227, comprising performing the identification of the upper airway collapse pattern at a time prior to the completion of implantation of a chronically implantable stimulator that is in a stimulating relationship with upper airway patency-related tissue.

231. The method according to claim 231, wherein the upper airway patency-related tissue includes at least one of the hypoglossal nerve and a non-hypoglossal nerve including the cervical nerve loop.

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