METHODS AND SYSTEMS FOR IMPROVING AIRWAY PATENCY

• US 20090120446A1
• Filed: 11/12/2008
• Published: 05/14/2009
• Est. Priority Date: 11/13/2007
• Status: Active Grant

• Current Assignee: Somnics inc.
• Original Assignee: ApniCure, Inc.
• Inventors: Vaska, Matthias, Daniel, Sean Christopher, Podmore, Jonathan, Crowe, John Edwards
• Granted Patent: US 8,122,889 B2
• Time in Patent Office: Days
• US Class Current: 128/848
• CPC Class Codes: A61F 5/566 Intra-oral devices

Abstract

An oral device for improving airway patency comprises a tongue constraint and a negative pressure source. The tongue constraint engages the patient'"'"'s tongue to maintain a clear region below the palate in an oral cavity. By applying a negative pressure in the clear region, an airway behind the soft palate or tongue of the patient can be maintained. The tongue constraint is usually connected to an anchor. The anchor may be held between the patient'"'"'s teeth or may engage the inferior surface of the palate. Another oral device for improving airway patency comprises a lateral tongue structure and a negative pressure source.

Claims

1. A method for improving airway patency in a patient having an oral cavity, a hard palate, a soft palate, a tongue, lips, and an airway, said method comprising:

placing an oral device in the oral cavity, the oral device having a tongue constraint to engage a medial surface of the tongue, the tongue constraint constraining the medial surface in a position spaced-apart from the hard palate, whereby a continuous vacuum flow path extends from the lips to the soft palate; and

applying a vacuum through the vacuum flow path to the soft palate, wherein the soft palate forms a seal against one or both of the tongue and the oral device such that the airway is substantially fluidly isolated from the vacuum flow path.

2. A method as in claim 1 wherein the tongue constraint engages the medial surface at a point at least about ⅓

of the distance from an anterior tip of the tongue to a posterior end of the tongue.

3. A method as in claim 1 wherein the tongue constraint comprises a plate having a width at least about ½

the width of the tongue.

4. A method as in claim 1 wherein the tongue constraint engages the medial surface at a point posterior to the midpoint between an anterior end of the hard palate and a posterior end of the hard palate.

5. A method as in claim 1 wherein the vacuum flow path comprises a clear region formed between the tongue and the hard palate.

6. A method as in claim 1 wherein the vacuum flow path comprises a vacuum lumen integral with or coupled to the oral device.

7. A method as in claim 1, further comprising delivering positive pressure to the airway posterior to the seal.

8. A method as in claim 7 wherein the positive pressure is delivered through the oral cavity.

9. A method as in claim 7 wherein the positive pressure is delivered through the nasal airway.

10. A method as in claim 1 further comprising positioning a pressure monitor in the oral cavity to monitor for leaks.

11. A method as in claim 2 wherein the clear region is in fluid communication with the soft palate through an opening facing away from the tongue.

12. A method as in claim 1 further comprising applying a vacuum to a superior surface of the tongue.

13. A method as in claim 12 wherein the vacuum is applied to the superior surface of the tongue through an inferior port in the oral device.

14. A method as in claim 1 further comprising applying a vacuum to a lateral surface of the tongue.

15. A method as in claim 1 wherein the vacuum is applied through a first port oriented away from the tongue such that the first port remains unblocked by the tongue.

16. A method as in claim 15 wherein the vacuum is further applied through a second port oriented toward the tongue.

17. A method as in claim 1, wherein the vacuum has a pressure in the range from −

5 cm H₂O to −

150 cm H₂O.

18. A method as in claim 1, further comprising sealing the patient'"'"'s lips to inhibit air entering the oral cavity while the vacuum is being applied.

19. A method as in claim 18, wherein sealing the lips comprises positioning a sealing structure between the lips and the teeth.

20. A method as in claim 1 further comprising repositioning the patient'"'"'s jaw from an undeflected position to a deflected position, and maintaining the jaw in the deflected position while the vacuum is applied.

21. A method as in claim 1 further comprising collecting saliva aspirated from the oral cavity by the vacuum.

22. A method for improving airway patency in a patient having an oral cavity, a hard palate, a soft palate, a tongue, and an airway, said method comprising:

constraining a medial surface of the patient'"'"'s tongue to maintain a clear region between the medial surface and the hard palate, the medial surface being at least in part posterior to the midpoint between an anterior end of the hard palate and a posterior end of the hard palate, the clear region being in fluid communication with the soft palate through a posterior opening configured to apply vacuum toward an anterior surface of the soft palate; and

applying a negative pressure within the clear region to hold the soft palate in a position in which the airway is at least partially open, wherein the posterior opening remains unobstructed by the tongue when the negative pressure is applied and the soft palate and tongue form a seal whereby the patient'"'"'s airway is substantially fluidly isolated from the clear region.

23. A method as in claim 22 wherein the medial surface is constrained at a point at least about ⅓

of the distance from an anterior tip of the tongue to a posterior end of the tongue.

24. A method as in claim 22 wherein the medial surface is constrained at a point at least about ½

of the distance from the anterior end of the hard palate to the posterior end of the hard palate.

25. A method as in claim 22 wherein the medial surface is constrained by a tongue constraint positioned in the patient'"'"'s oral cavity.

26. A method as in claim 25 wherein the tongue has a width and the tongue constraint engages the tongue across at least a majority of the width.

27. A method as in claim 26 wherein the tongue constraint comprises a plate.

28. A method as in claim 27 wherein the plate spans across a space between the patient'"'"'s left and right molars.

29. A method as in claim 25 wherein the clear region is in communication with at least one inferior port in the tongue constraint facing toward the tongue.

30. A method as in claim 29 wherein when negative pressure is applied at least one inferior port is blocked by the tongue while the posterior opening remains unobstructed by the tongue.

31. A method as in claim 25 wherein the soft palate engages one or both of the tongue and the tongue constraint to create the seal.

32. A method as in claim 22 wherein fluid within the clear region is in direct contact with an inferior surface of the hard palate.

33. A method as in claim 25 wherein the negative pressure is applied through at least one vacuum lumen coupled to or integral with the tongue constraint.

34. A method as in claim 25, wherein the negative pressure is applied through at least one vacuum lumen positioned in the oral cavity separately from the tongue constraint.

35. A method as in claim 25, further comprising positioning an anchor structure in the oral cavity, the tongue constraint being coupled to or integral with the anchor structure.

36. A method as in claim 35 wherein the tongue constraint has opposing lateral edges extending from an anterior end to a posterior end thereof, at least a posterior portion of the lateral edges being fixed to the anchor structure.

37. A method as in claim 35 wherein positioning the anchor structure comprises holding a bite structure between the teeth.

38. A method as in claim 37, wherein the bite structure comprises at least one bite surface which is held between the teeth.

39. A method as in claim 37, wherein the bite structure comprises a tooth-receiving channel which receives the teeth.

40. A method as in claim 35, wherein positioning the anchor structure comprises engaging a hard palate engagement surface against the hard palate to hold the anchor in position.

41. A method as in claim 22 further comprising placing a lip seal along the patient'"'"'s lips to help seal the oral cavity when the negative pressure is applied.

42. A method as in claim 25, wherein the negative pressure is applied through a plenum network coupled to or integral with the tongue constraint.

43. A method as in claim 42, wherein the plenum network extends within at least a portion of the tongue constraint.

44. A method as in claim 42, wherein the plenum network extends within a bite structure coupled to or integral with the tongue constraint.

45. A method as in claim 42, wherein the plenum network extends down at least one lateral side of the tongue.

46. A method as in claim 22 further comprising detecting a leak in the sealed region of the oral cavity with a detector positioned in the oral cavity.

47. A method as in claim 22 further comprising receiving an indication of airway patency from a sensor positioned in the oral cavity.

48. A method as in claim 22 further comprising aspirating liquid which accumulates in the oral cavity.

49. A method as in claim 48, further comprising maintaining a substantially constant negative pressure while the liquid is aspirated.

50. A method as in claim 22 further comprising delivering positive pressure to the airway while the negative pressure is applied.

51. A method as in claim 50 wherein the positive pressure is delivered through the oral cavity.

52. A method as in claim 50 wherein the positive pressure is delivered through the nasal airway.

53. A method as in claim 22 further comprising repositioning the patient'"'"'s jaw from an undeflected position to a deflected position, and maintaining the jaw in the deflected position while the negative pressure is applied.

54. A method as in claim 22 wherein the posterior opening lies in a first plane which is disposed at an angle of at least about 45 degrees relative to an occlusal plane defined by a plane of contact between the patient'"'"'s upper and lower teeth.

55. A method as in claim 54 wherein the first plane is about 45-180 degrees relative to the occlusal plane.

56. A method as in claim 25 wherein the posterior opening is bounded on an inferior side by the tongue constraint and on a superior side by the patient'"'"'s hard or soft palate.

57. A method as in claim 22 wherein the soft palate has an upper portion with an upper end joined to the hard palate and a lower portion with a lower end which is unattached, and wherein the posterior opening is configured to apply negative pressure directly to the upper portion when the airway is open.

58. Apparatus for improving airway patency comprising:

an oral device positionable in a patient'"'"'s oral cavity and having a tongue constraint to constrain a medial surface of the patient'"'"'s tongue in a position spaced-apart from the hard palate, the oral device providing a continuous vacuum flow path from the patient'"'"'s lips to the patient'"'"'s soft palate, the oral device being configured to maintain a seal between the soft palate and one or both of the tongue and the oral device when vacuum is applied through the vacuum flow path such that the airway is substantially fluidly isolated from the vacuum flow path.

59. Apparatus as in claim 58 wherein the tongue constraint is configured to engage the medial surface at a point at least about ⅓

of the distance from an anterior tip of the tongue to a posterior end of the tongue.

60. Apparatus as in claim 58 wherein the tongue has a width and the tongue constraint is configured to engage the tongue across at least a majority of the width.

61. Apparatus as in claim 60 wherein the tongue constraint comprises a plate.

62. Apparatus as in claim 58 wherein the tongue constraint is configured to engage the medial surface at a point posterior to the midpoint between an anterior end of the hard palate and a posterior end of the hard palate.

63. Apparatus as in claim 58 wherein the vacuum flow path comprises a clear region formed between the tongue and the hard palate.

64. Apparatus as in claim 58 wherein the vacuum flow path comprises a vacuum lumen integral with or coupled to the oral device.

65. Apparatus as in claim 58, further comprising a delivery lumen coupled to the oral device adapted to deliver positive pressure to the airway.

66. Apparatus as in claim 58 further comprising a pressure monitor coupled to the oral device.

67. Apparatus as in claim 58 further comprising an oximetry sensor coupled to the oral device.

68. Apparatus as in claim 63 wherein the clear region is in fluid communication with the soft palate through an opening configured to apply vacuum to an anterior surface of the soft palate.

69. Apparatus as in claim 68 wherein the oral device comprises an inferior port in communication with the vacuum flow path and configured to apply vacuum to a superior surface of the tongue.

70. Apparatus as in claim 58 wherein the oral device further comprises a lateral port configured to apply vacuum to a lateral surface of the tongue.

71. Apparatus as in claim 58 wherein the oral device comprises a posterior port in communication with the vacuum flow path and facing away from the tongue so as remain unblocked by the tongue when vacuum is applied.

72. Apparatus as in claim 71 wherein the oral device further comprises an inferior port oriented toward the tongue.

73. Apparatus as in claim 72 wherein the inferior port is in communication with the vacuum flow path.

74. Apparatus as in claim 72 wherein the inferior port is in communication with a vacuum lumen fluidly separate from the vacuum flow path.

75. Apparatus of claim 58, further comprising a lip seal for sealing the patient'"'"'s lips to inhibit leaks into the oral cavity.

76. Apparatus as in claim 72, wherein the lip seal comprises a sealing structure positionable between the lips and the teeth.

77. Apparatus as in claim 58 further comprising a jaw engagement structure coupled to the oral device adapted to maintain the patient'"'"'s jaw in a deflected position selected to help keep the airway open.

78. Apparatus of claim 77 wherein the jaw engagement structure comprises a tab on the oral device adapted to engage the patient'"'"'s lower teeth to maintain the lower jaw in an anterior position.

79. Apparatus of claim 77 wherein the jaw engagement structure comprises a spacer disposed on the oral device and positionable between the patient'"'"'s upper and lower teeth to maintain the jaw in an open position.

80. Apparatus as in claim 64 wherein the oral device further comprises an anchor structure adapted to maintain the position of the oral device within the oral cavity.

81. Apparatus as in claim 80 wherein the tongue constraint has opposing lateral edges extending from an anterior end to a posterior end thereof, at least a posterior portion of the lateral edges being fixed to the anchor structure.

82. Apparatus as in claim 80 wherein the anchor structure comprises a bite structure adapted to be held by the patient'"'"'s teeth.

83. Apparatus as in claim 58 further comprising a vacuum source connectable to the oral device in fluid communication with the vacuum flow path.

84. An oral device for improving patency of a patient'"'"'s airway, comprising:

a tongue constraint positionable in an oral cavity and adapted to engage a medial surface of a tongue and constrain the medial surface in a position spaced-apart from a hard palate so as to create a clear region therebetween, the medial surface being at least in part posterior to the midpoint between an anterior end of the hard palate and a posterior end of the hard palate, the clear region being in communication with a soft palate through a posterior opening configured to apply vacuum toward an anterior surface of the soft palate; and

means for conveying a vacuum to the clear region while the tongue constraint engages the tongue such that the soft palate is held in a position in which the airway is at least partially open and the posterior opening remains unobstructed by the tongue, wherein the soft palate and tongue form a seal whereby the patient'"'"'s airway is substantially fluidly isolated from the clear region.

85. An oral device as in claim 84 wherein the tongue constraint is configured to engage the medial surface at a point at least about ⅓

of the distance from an anterior tip of the tongue to a posterior end of the tongue.

86. An oral device as in claim 84 wherein the tongue has a width and the tongue constraint is configured to engage the tongue across at least a majority of the width.

87. An oral device as in claim 86 wherein the tongue constraint comprises a plate.

88. An oral device as in claim 87 wherein the plate is configured to span across a space between the patient'"'"'s left and right molars.

89. An oral device as in claim 84 wherein the clear region is further in communication with at least one inferior port in the tongue constraint facing toward the tongue.

90. An oral device as in claim 84 wherein the tongue constraint is adapted to maintain the soft palate in engagement with one or both of the tongue and the tongue constraint to create the seal when vacuum is conveyed to the clear region.

91. An oral device as in claim 84 wherein the tongue constraint is configured such that fluid within the clear region directly contacts an inferior surface of the hard palate.

92. An oral device as in claim 84 wherein the means for conveying the vacuum comprises at least one vacuum lumen coupled to or integral with the tongue constraint.

93. An oral device as in claim 84 further comprising an anchor structure coupled to or integral with the tongue constraint.

94. An oral device as in claim 93 wherein the tongue constraint has opposing lateral edges extending from an anterior end to a posterior end thereof, at least a posterior portion of the lateral edges being fixed to the anchor structure.

95. An oral device as in claim 93 wherein the anchor structure comprises a bite structure positionable between the upper and lower teeth.

96. An oral device as in claim 95, wherein the bite structure comprises a tooth-receiving channel which receives the teeth.

97. An oral device as in claim 95, wherein the anchor structure comprises a hard palate engagement surface positionable against the hard palate to hold the tongue constraint in position.

98. An oral device as in claim 84 further comprising a lip seal positionable along the patient'"'"'s lips to help seal the oral cavity when vacuum is applied.

99. An oral device as in claim 84, wherein the means for conveying a vacuum comprises a plenum network coupled to or integral with the tongue constraint.

100. An oral device as in claim 99, wherein the plenum network extends within at least a portion of the tongue constraint.

101. An oral device as in claim 99, wherein the plenum network extends within a bite structure coupled to or integral with the tongue constraint.

102. An oral device as in claim 99, wherein the plenum network extends down at least one lateral side of the tongue.

103. An oral device as in claim 84 further comprising a pressure sensor coupled to the tongue constraint for monitoring pressure in the oral cavity.

104. An oral device as in claim 84 further comprising an oximetry sensor coupled to the tongue constraint for monitoring the patient'"'"'s oxygen level.

105. An oral device as in claim 84 further comprising a pressure lumen coupled to the tongue constraint adapted to deliver positive pressure to the airway.

106. An oral device as in claim 84 further comprising a jaw engagement structure coupled to the tongue constraint and adapted to maintain the patient'"'"'s jaw in a deflected position selected to help keep the airway open.

107. An oral device as in claim 106 wherein the jaw engagement structure comprises a tab on the oral device adapted to engage the patient'"'"'s lower teeth to maintain the lower jaw in an anterior position.

108. An oral device as in claim 106 wherein the jaw engagement structure comprises a spacer disposed on the oral device and positionable between the patient'"'"'s upper and lower teeth to maintain the jaw in an open position.

109. An oral device as in claim 84 further comprising a soft pad on a posterior surface of the tongue constraint configured to engage the soft palate.

110. An oral device as in claim 84 further comprising a soft pad on an inferior surface of the tongue constraint configured to engage the tongue.

111. An oral device as in claim 95 wherein the tongue constraint is movably coupled to the anchor structure to allow the tongue constraint to move anteriorly within the jaw cavity to reposition the tongue therein.

112. An oral device as in claim 84 further comprising a soft palate landing surface coupled to or integral with the tongue constraint, the soft palate landing surface having a posterior surface adapted to engage the soft palate when the soft palate is in the position wherein the airway is at least partially open.

113. An oral device as in claim 112 wherein the soft palate landing surface is movably coupled to the tongue constraint.

114. An oral device as in claim 112 wherein the soft palate landing surface has a posterior port thereon adapted to convey a vacuum toward the soft palate.

115. An oral device as in claim 112 wherein the posterior surface is disposed at an angle of at least about 90 degrees relative to an occlusal plane defined by a plane of contact between the patient'"'"'s upper and lower teeth.

116. An oral device as in claim 112 wherein the soft palate landing surface comprises a wall extending superiorly from a posterior edge of the tongue constraint.

117. An oral device as in claim 84 wherein the posterior opening lies in a first plane which is disposed at an angle of at least about 45 degrees relative to an occlusal plane defined by a plane of contact between the patient'"'"'s upper and lower teeth.

118. An oral device as in claim 117 wherein the first plane is about 45-180 degrees relative to the occlusal plane.

119. An oral device as in claim 84 wherein the posterior opening is bounded on an inferior side by the tongue constraint and on a superior side by the patient'"'"'s hard or soft palate.

120. An oral device as in claim 84 wherein the soft palate has an upper portion with an upper end joined to the hard palate and a lower portion with a lower end which is unattached, and wherein the posterior opening is configured to apply negative pressure to the upper portion when the airway is open.

121. A system for monitoring airway patency comprising:

an oral device positionable in a patient'"'"'s oral cavity and adapted to maintain a continuous vacuum flow path from the patient'"'"'s lips to the patient'"'"'s soft palate and substantially seal the patient'"'"'s airway from the vacuum flow path;

a vacuum source coupled to the oral device in fluid communication with the vacuum flow path; and

a sensor coupled to the oral device for detecting at least one condition within the oral cavity.

122. A system as in claim 121 further comprising a recording device coupled to the sensor and adapted to record data received from the sensor over a time period.

123. A system as in claim 121 further comprising a controller coupled to the sensor and the vacuum source for controlling the vacuum source in response to signals generated by the sensor.

124. A system as in claim 123 wherein the sensor comprises a pressure sensor and the controller is adapted to automatically regulate the vacuum source so as to maintain a substantially constant negative pressure in the oral cavity.

125. A system as in claim 122 wherein the recording device comprises a memory device.

126. A system as in claim 125 further comprising a computer in communication with the memory device.

127. A system as in claim 126 further comprising a display adapted to display information from the memory device to the user.

128. A system as in claim 126 further comprising a user input device adapted to transmit information from the user to the computer.

129. A system as in claim 121 wherein the sensor is attached to the oral device so as to be positionable in the oral cavity.

130. A system as in claim 121 further comprising a tube attached to the oral device and having a port located in the oral cavity when the oral device is positioned therein, the sensor being in communication with the tube outside the oral cavity.

131. A system as in claim 121 wherein the sensor comprises a pressure sensor adapted to detect pressure in the patient'"'"'s oral cavity.

132. A system as in claim 121 wherein the sensor comprises an oximetry sensor adapted to detect oxygen levels in the oral cavity or in the patient'"'"'s tissue.

133. A system as in claim 121 wherein the sensor comprises an impedance sensor adapted to detect contact between the oral device and tissues in the oral cavity.

134. A system as in claim 121 wherein the sensor comprises an accelerometer adapted to detect the orientation of the patient'"'"'s head.

135. A system as in claim 121 wherein the sensor comprises a piezoelectric sensor for detecting a sound selected from breathing, snoring, teeth grinding, or heartbeat.

136. A system as in claim 121 wherein the sensor comprises a temperature sensor.

137. A system as in claim 136 wherein the temperature sensor is adapted to detect the temperature of air in or adjacent to the nasal airway.

138. A system as in claim 121 further comprising a transmission device for electronically transmitting information from the recording device to an external device.

139. A system as in claim 138 wherein the transmission device is selected from a modem, a docking station, a cable connector, and a wireless transmitter.

140. A system as in claim 121 wherein the oral device is adapted to maintain the soft palate in sealing engagement with the tongue such that the airway is substantially fluidly isolated from the vacuum flow path.

141. A system as in claim 121 wherein the sensor is adapted to monitor whether the airway is substantially fluidly isolated from the vacuum flow path.

142. A system as in claim 141 wherein the sensor is a pressure sensor for monitoring pressure in the oral cavity.

143. A system as in claim 141 wherein the sensor is a flow sensor for monitoring flow rate through the vacuum flow path.

144. A system as in claim 121 further comprising an alarm adapted to provide a visual or audible signal in response to data received from the sensor.

145. A system as in claim 121 further comprising a liquid collector in communication with the vacuum source for collecting liquid aspirated from the oral cavity.

146. A system as in claim 145 wherein the vacuum source is adapted to automatically maintain substantially constant negative pressure in the oral cavity when liquid is being aspirated.

147. A system as in claim 122 wherein the time period is selectable by the user to be any of a plurality of times periods.

148. A system as in claim 121 further comprising at least a second sensor for monitoring a second condition in the oral cavity.