Methods and devices for minimally invasive respiratory support

• US 8,381,729 B2
• Filed: 08/03/2007
• Issued: 02/26/2013
• Est. Priority Date: 06/18/2003
• Status: Active Grant

• Current Assignee: Breathe Technologies, Inc. (Baxter International Inc.)
• Original Assignee: Breathe Technologies, Inc. (Baxter International Inc.)
• Inventors: Freitag, Lutz, Wondka, Anthony, Kapust, Gregory, Bryan, Robert, Khenansho, Michael, Gerber, Anthony
• Primary Examiner(s): DOUGLAS, STEVEN O
• Application Number:
  US11/882,530
• Publication Number:
  US 20080135044A1
• Time in Patent Office: 2,034 Days
• Field of Search: 128/200.26, 128/207.14, 128/207.15, 128/207.16, 604/516, 604/518, 604/514, 604/509, 604/48, 604/28, 604/35, 424/423, 607/99, 600/114, 600/116, 606/108
• US Class Current: 128/207.14
• CPC Class Codes: A61M 16/101 using an oxygen concentrator
• CPC Class Codes: A61M 16/107 in the inspiratory path
• CPC Class Codes: A61M 16/16 Devices to humidify the respiration air A61M16/1045 takes precedence
• CPC Class Codes: A61M 2202/0007 introduced into the body
• CPC Class Codes: A61M 2202/0208 Oxygen
• CPC Class Codes: A61M 2202/03 Gases in liquid phase, e.g. cryogenic liquids

Abstract

Modes, methods, systems and devices are described for providing assisted ventilation to a patient, including wearable ventilation systems with integral gas supplies, special gas supply features, ventilation catheters and access devices, and breath sensing techniques.

Claims

1. A ventilatory support apparatus, comprising:

(a) a ventilator;

(b) a tubing adapted to be in communication with a patient'"'"'s airway;

(c) a breath sensor adapted to measure spontaneous airflow of the patient'"'"'s airway; and

(d) a delivery mechanism for delivering a volume of ventilation gas at a rate synchronized with the patient'"'"'s spontaneous breathing and delivered during the patient'"'"'s inspiratory phase.

2. The apparatus of claim 1, wherein the ventilator is configured to be worn by the patient.

3. The apparatus of claim 1, wherein the ventilator includes an integrated supply of oxygen volume.

4. The apparatus of claim 1, wherein the ventilator includes an integrated oxygen generating system.

5. The apparatus of claim 1, wherein the ventilation gas volume to be delivered is 5-50% of a patient'"'"'s natural tidal volume.

6. The apparatus of claim 1, wherein a ventilation gas driving pressure is 5-25 psi.

7. The apparatus of claim 1, wherein a ventilation peak flow rate delivery is 12-50 liters per minute.

8. The apparatus of claim 1, wherein a ventilation gas delivery time is 0.1 to 0.8 seconds.

9. The apparatus of claim 1, wherein the tubing includes a tip and a ventilation gas exit speed out of the tip is 25-400 meters per second.

10. The apparatus of claim 1, wherein ventilation gas exit airflow dynamics are selected to cause 25-200% volume entrainment of gas from an upper airway into a lung with the ventilation gas.

11. The apparatus of claim 1, wherein a ventilation gas delivery amplitude is selected to cause a less negative pressure in a patient'"'"'s lung during inspiration compared to a negative pressure during un-assisted breathing.

12. The apparatus of claim 1, wherein a ventilation gas delivery amplitude is selected to cause a positive pressure in a patient'"'"'s lung during inspiration compared to a negative pressure during un-assisted breathing.

13. The apparatus of claim 1, wherein the breath sensor comprises two individual sensors used to obtain a comparison between the two individual sensors wherein a comparison is used to compensate for drifts and signal artifacts.

14. The apparatus of claim 13, wherein the individual sensor comparison is differentiated to correlate the signal to different parts of the breathing curve.

15. The apparatus of claim 1, further comprising a ventilation gas source.

16. The apparatus of claim 15, wherein the ventilation gas source is a liquid oxygen system.

17. The apparatus of claim 15, wherein the ventilation gas source is a compressed oxygen gas source.

18. The apparatus of claim 15, wherein the ventilation gas source is an oxygen generating system.

19. The apparatus of claim 1, wherein the sensor comprises means to measure the strength and direction of airflow to deliver the ventilation gas after the inspiratory flow rate reaches a peak amplitude.

20. The apparatus of claim 1, wherein the sensor signal is correlated to respiratory muscle activity to provide means to deliver the ventilation gas after respiratory muscles reach their maximum work.

21. The apparatus of claim 1, wherein the delivery mechanism delivers gas after respiratory muscles reach their maximum work.

22. The apparatus of claim 1, wherein the delivery mechanism delivers gas in multiple pulses during inspiration.

23. The apparatus of claim 1, comprising means for adjusting the ventilation gas delivery to occur at any time within the inspiratory phase, depending on the comfort and ventilatory needs of the patient, wherein a time in the inspiratory phase is determined by information from the breath sensor.

24. The apparatus of claim 23, wherein the adjustment means is capable of adjusting the ventilation gas delivery automatically by a physiological feedback mechanism.

25. The apparatus of claim 24, wherein the feedback mechanism is based on airway gas concentrations.

26. The apparatus of claim 24, wherein the feedback mechanism is based on depth of breathing.

27. The apparatus of claim 24, wherein the feedback mechanism is based on rate of breathing.

28. The apparatus of claim 24, wherein the feedback mechanism is based on pulse oximetry.

29. The apparatus of claim 23, wherein the adjustment means is capable of being made manually by the user.

30. The apparatus of claim 23, wherein the adjustment means is capable of being adjusted by a patient.

31. The apparatus of claim 23, wherein the adjustment means is capable of being adjusted by the clinician.

32. The apparatus of claim 1, wherein the ventilation gas delivery means is a primary ventilation gas delivery means and the apparatus further comprises means for delivering a secondary ventilation gas, the secondary gas delivery means comprising a lower gas flow rate compared to the primary ventilation gas delivery.

33. The apparatus of claim 32, comprising means to deliver the secondary ventilation gas early in inspiration.

34. The apparatus of claim 32, comprising means to deliver the secondary ventilation gas throughout inspiration.

35. The apparatus of claim 32, comprising means to deliver the secondary ventilation gas during exhalation.

36. The apparatus of claim 32, wherein the secondary ventilation gas displaces CO2 in the upper airway, such that the primary ventilation gas when delivered entrains air from the upper airway into the lower airways, wherein the entrained air is low in CO2, at least 2% lower in CO2 compared to when the secondary ventilation gas is turned off.

37. The apparatus of claim 32, wherein the secondary ventilation gas comprises a high oxygen concentration, such as 50%-100% and the primary ventilation gas comprises a lower oxygen concentration, such as 21%-60%.

38. The apparatus of claim 32, comprising means to adjust one of a pressure and a flow rate amplitude of the ventilation gas delivery.

39. The apparatus of claim 1, comprising means to adjust the shape of the ventilation gas delivery pressure or flow rate waveform into a desired waveform, including at least one of a sine wave, an ascending wave, a descending wave or a square wave, wherein the adjusting means comprises at least one of a valve, an orifice, a piston and a regulator.

40. The apparatus of claim 1, wherein the ventilation gas delivery comprises a primary ventilation gas delivery and the apparatus further comprises means to delivery gas into an airway during exhalation to provide a counter-resistance to exhaled flow, wherein the counter-resistance gas flow dynamics are selected to reduce airway collapse.

41. The apparatus of claim 40, comprising means to deliver the counter-resistance gas at a selectable strategic time within the expiratory phase including one of early in exhalation or late in exhalation.

42. The apparatus of claim 40, wherein the counter-resistance gas delivery occurs throughout exhalation.

43. The apparatus of claim 40, comprising means to deliver the counter-resistance gas in an oscillatory pattern.

44. The apparatus of claim 40, comprising means to deliver the counter-resistance gas in a turbulent pattern.

45. The apparatus of claim 40, comprising means to deliver the counter-resistance gas in a laminar pattern.

46. The apparatus of claim 40, wherein the counter-resistance gas delivery dynamics create a substantially uniform velocity profile in the airway.

47. The apparatus of claim 40, wherein the counter-resistance gas delivery dynamics create a substantially non-uniform velocity profile in the airway.

48. The apparatus of claim 1, comprising means, in addition to the primary ventilation gas delivery, to actively remove airway gas from the airway to reduce the CO2 content of gas in the airway.

49. The apparatus of claim 1, wherein the ventilation gas comprises at least one of following:

oxygen, or helium-oxygen mixtures, or nitric oxide mixtures, or other therapeutic gases.

50. The apparatus of claim 1, comprising means to deliver a medicant.

51. The apparatus of claim 1, further comprising means to deliver one or more conjunctive therapies and (a) a secondary gas delivery;

(b) a delivery of gas during exhalation to cause exhaled flow counter-resistance;

(c) a removal of gas from the airway;

(d) delivery of a therapeutic gas such as helium-oxygen or nitric oxide;

(e) delivery of a medication.

52. The apparatus of claim 51, further comprising means to adjust the conjunctive therapies based on the needs of the patient, wherein the adjustment means can be manual or automatic based on a feedback, and wherein the adjustment means can permit turning the conjunctive therapy on or off or varying the amplitude of the conjunctive therapy.

54. The apparatus of claim 1, comprising means to regulate pressure output from the gas source, an accumulator to accumulate gas at the regulated pressure, an on/off valve for controlling flow output from the accumulator to the patient and the sensor comprises breath sensors to determine the breath phase of the patient.

55. The apparatus of claim 1, wherein the ventilation gas source comprises a compressed oxygen gas canister comprising a regulator wherein the regulator comprises a gas output orifice configured to provide an output of 10-40 psi and greater than 6 liters per minute.

56. The apparatus of claim 1, further comprising a gas accumulator, wherein the accumulator accumulates the volume of gas being delivered to the patient in one breath for each breath delivered.

57. The apparatus of claim 56, wherein the accumulator is a cylinder with a stroking piston.

58. The apparatus of claim 1, further comprising a gas volume accumulator comprising:

(a) a cylinder, (b) a stroking piston within the cylinder, (c) an inlet and outlet port on one side of the piston and an spring element on the opposite side of the piston, (d) a valve means to control the filling and emptying of the cylinder, wherein the spring element comprises a spring force sufficient to accelerate the emptying of the gas out of the cylinder to the patient.

59. The apparatus of claim 1, further comprising a gas volume accumulator comprising a cylinder with an internal stroking piston, wherein a geometric volume of the cylinder is adjustable.

60. The apparatus of claim 59, wherein the cylinder volume adjustment means is a moveable end-cap on one end of the cylinder wherein the end-cap slides axially in the inner diameter of the cylinder.

61. The apparatus of claim 59, wherein the cylinder volume adjustment is adjusted manually, for example by rotation of a knob.

62. The apparatus of claim 59, wherein the cylinder volume adjustment is adjusted automatically, for example by use of a motor.

63. The apparatus of claim 59, wherein the cylinder volume adjustment is monitored by use of a position scale, such as an axial scale to determine the position of said end-cap, or a radial scale to determine the position of said knob.

64. The apparatus of claim 59, wherein the cylinder volume adjustment is monitored by use of a position sensor, such as an axial sensor to determine the position of the end-cap, or a radial sensor to determine the position of the knob.

65. The apparatus of claim 1, further comprising valves and control means to shape a ventilation gas delivery profile as desired, such as a sine wave, square wave or accelerating or decelerating wave.

66. The apparatus of claim 1, further comprising a gas accumulator wherein the gas accumulator is shaped non-cylindrically.

67. The apparatus of claim 1, further comprising a gas accumulator wherein the gas accumulator is shaped with a concave curve.

68. The apparatus of claim 1, further comprising a gas accumulator wherein the gas accumulator comprises a bone-shaped cross section.

69. The apparatus of claim 1, further comprising a gas accumulator wherein the gas accumulator comprises an array of separate interconnected cylinders.

70. The apparatus of claim 1, further comprising a gas accumulator wherein the gas accumulator is comprised of tubing.

71. The apparatus of claim 1, wherein a ventilation gas supply reservoir is configured non-cylindrically, such as but not limited to a concave shape, a bone-shaped cross section, an array of interconnected cylinders, or curved conduit.

72. The apparatus of claim 1, wherein the tubing includes a tip that is restricted to provide the desired amount of gas exit speed, typically 50 to 400 meters per second and preferably 100-250 meters per second.

73. The apparatus of claim 72, wherein the tip is restricted to produce the desired amount of entrainment of upper airway air, typically 25-200%.

74. The apparatus of claim 72, wherein the tip restriction is constant.

75. The apparatus of claim 72, wherein the tip restriction is variable.

76. The apparatus of claim 72, wherein the tip restriction is variable wherein the restriction is varied by the use of an adjustable member in the gas flow lumen of the tip.

77. The apparatus of claim 76, wherein the adjustable member adjusts radially to decrease or increase the gas flow lumen diameter.

78. The apparatus of claim 76, wherein the adjustable member axially slides to actuate an increase or decrease in the gas flow lumen diameter.

79. The apparatus of claim 1, wherein the gas flow lumen is restricted to produce an exit speed of typically 50-400 meters per second.

80. The apparatus of claim 79, wherein the gas flow lumen tip diameter is restricted to an inner diameter of 0.5 mm to 2.0 mm.

81. The apparatus of claim 1, comprising a main ventilation gas flow opening at the distal tip to deliver the main ventilation gas toward the lung, and comprising a secondary opening configured to direct delivery of the secondary gas upward toward the larynx.

82. The apparatus of claim 1, comprising gas flow ports near the distal tip wherein the ports are configured to allow gas to exit the tubing multi-directionally, wherein the ports and multidirectional flow is selected to produce a uniform or semi-uniform velocity profile in the airway.

83. The apparatus of claim 1, comprising a generally 360°

curve at its end which is inserted into the trachea, wherein the gas delivery lumen is blocked to gas flow at the tip of the tubing, and comprising a gas exit port located on the curved section of the tubing at a location to direct the exiting gas flow toward the lung, and wherein the radius of the curve positions a portion of the curve against the anterior tracheal wall.

84. The apparatus of claim 1, comprising a generally a 540°

curve at its end which is inserted into the trachea, wherein the curve positions the tip of the tubing pointing toward the lung, wherein the radius of the curve positions a portion of the curve against the anterior and posterior wall of the trachea.

85. The apparatus of claim 1, comprising an outer cannula sleeve, wherein the outer cannula sleeve comprises a stomal sleeve, and wherein the outer cannula sleeve directs the tip to the center of the trachea.

86. The apparatus of claim 1, comprising (a) a spacer positioned inside the trachea used to space the tubing away from the stomal tissue;

(b) a curve configured to a position of the distal section of the tubing against the anterior tracheal wall;

(c) a curve to position the tip of the tubing away from the airway wall and directed toward the lungs.

87. The apparatus of claim 1, with a distal section that is inserted into a patient wherein the inserted section is comprised of a soft material of 20-80 Shore A and further comprising a rigid member imbedded into the construction to provide the soft material semi-rigidity.

88. The apparatus of claim 87, wherein the rigid member is a spring material.

89. The apparatus of claim 87, wherein the rigid member is a shape memory alloy material.

90. The apparatus of claim 87, wherein the rigid member is a malleable material.

91. The apparatus of claim 1, wherein the catheter comprises thermally responsive material in its construction which causes a change from a first shape to a second shape of the tubing when reaching body temperature, wherein the first shape is configured to aide in insertion of the tubing and the second shape is configured to aide in atraumatic positioning of the tubing in the airway and to direct the gas exit of the catheter to the lungs.

92. The apparatus of claim 1, wherein a patient end of the tubing is configured to connect to a standard 15 mm connector a tracheal tube, such as a tracheostomy tube or laryngectomy tube, and comprising a sensor extension that extends into the shaft of the tracheal tube or beyond the distal tip of the tracheal tube.

93. The apparatus of claim 1, comprising at its distal tip a radially expandable or compressible basket configured to anchor the tubing in the airway and position the tip of the tubing generally in the center of the airway.

94. The apparatus of claim 1, comprising a outer diameter mating stomal sleeve configured for insertion into the stomal tract and for insertion of the tubing through the sleeve, wherein the sleeve further comprises a spacer on its distal end configured to position the catheter tip away from the anterior tracheal wall.

95. The apparatus of claim 1, comprising:

(a) a distal section inserted into the trachea wherein the distal inserted section comprises a generally 90°

curve to position the tip the tubing to be pointing toward the lungs;

(b) an flange placed on the tubing shaft positioned outside the patient comprising means to axially adjust the placement of the flange on the catheter shaft and comprising means to lock the axial position of flange on the catheter shaft;

(c) length markings on the tubing shaft to correspond to the flange position.

96. The apparatus of claim 1, comprising a compressible member for sealing with and securing to the stomal tract.

97. The apparatus of claim 1, comprising a signal element recognizable by the ventilator, wherein the signal element defines a therapeutic attribute of the tubing, such as patient compatibility, intended disease state, or length of usage of therapy by the patient, and wherein the ventilator comprises the ability to recognize the signal element and alter its output based on the signal.

98. The apparatus of claim 1, wherein the breath sensor comprises two sensors wherein a first sensor is a negative coefficient thermistor and a second sensor is a positive coefficient thermistor.

99. The apparatus of claim 1, wherein the breath sensor comprises two pair of thermistors, wherein each pair is connected to a wheatstone bridge circuit, and wherein one pair of thermistors are negative coefficient thermistors and the second pair of thermistors are positive coefficient thermistors.

100. The apparatus of claim 1, wherein the breath sensor comprises at least two thermistors, wherein at least one thermistor is located on the surface of the tubing facing the larynx and at least one thermistor is located on the surface of the tubing facing the lungs.

101. The apparatus of claim 1, wherein the tubing comprises dimensions of 0.5-15 cm insertion length, 20-200 cm overall length, working inner diameter of 2.0-4.0 mm, nozzle diameter at tip of tubing of 0.7-1.0 mm, and outer diameter of insertion section of 2.0-6.5 mm.

151. The apparatus of claim 1, wherein the tubing is a catheter adapted to be indwelling in the patient'"'"'s airway.

152. The apparatus of claim 1, wherein the breath sensor is adapted to measure spontaneous airflow directly in the patient'"'"'s airway.

153. The apparatus of claim 1, further comprising a means for adjusting the ventilation gas delivery to occur at any tine within the inspiratory phase.

154. The apparatus of claim 153, wherein the adjustment means is capable of adjusting the ventilation gas delivery automatically by a physiological feedback mechanism.

53. An apparatus for providing ventilatory assistance to a patient wherein a gas volume is delivered into an airway of the patient via a tubing in communication with the airway and wherein the apparatus is adapted such that:

(a) the gas volume is delivered at a rate in synchrony with the patient'"'"'s spontaneous breathing and delivered during the patient'"'"'s inspiratory phase;

(b) the gas volume delivered is 5-50% of the patient'"'"'s natural tidal volume;

(c) a driving pressure in the catheter is 5-25 psi, a peak flow rate of gas delivery is 12-50 liters per minute;

(d) a gas delivery time is 0.1 to 0.8 seconds;

(e) an exit speed of gas out of the catheter tip is 25-400 meters per second causing 25-200% volume entrainment; and

(f) the ventilator is synchronized with the patient'"'"'s breathing pattern by using a breath sensor in communication with the airway to measure spontaneous airflow.

102. A method for providing ventilatory assistance to a patient, comprising the steps of:

(a) delivering a gas volume into the airway via a tubing in communication with a patient airway;

(b) synchronizing the delivery volume to a rate synchronized with the patient'"'"'s spontaneous breathing;

(c) delivering the delivery volume during the patient'"'"'s inspiratory phase;

(d) providing the gas volume by a wearable ventilator;

(e) synchronizing the ventilator with the patient'"'"'s breathing pattern by using a breath sensor in communication with the patient'"'"'s airway to measure spontaneous airflow.

103. The method of claim 102, wherein the ventilation gas volume delivered is 5-50% of the patient'"'"'s natural tidal volume.

104. The method of claim 102, wherein the ventilation gas driving pressure is 5-25 psi.

105. The method of claim 102, wherein the ventilation peak flow rate delivery is 12-50 liters per minute.

106. The method of claim 102, wherein the ventilation gas delivery time is 0.1 to 0.8 seconds.

107. The method of claim 102, wherein the ventilation gas exit speed out of the catheter tip is 25-400 meters per second.

108. The method of claim 102, wherein the ventilation gas exit airflow dynamics are selected to cause 25-200% volume entrainment of gas from the upper airway into the lung with the ventilation gas.

109. The method of claim 102, wherein the ventilation gas delivery amplitude is selected to cause a less negative pressure in the patient'"'"'s lung during inspiration compared to the negative pressure during un-assisted breathing.

110. The method of claim 102, wherein the ventilation gas delivery amplitude is selected to cause a positive pressure in the patient'"'"'s lung during inspiration compared to the negative pressure during un-assisted breathing.

111. The method of claim 102, wherein the breath sensor comprises two individual sensors used to obtain a comparison between the two individual sensors wherein the comparison is used to compensate for drifts and signal artifacts.

112. The method of claim 102, wherein the individual sensor comparison is differentiated to correlate the signal to different parts of the breathing curve.

113. The method of claim 102, wherein a liquid oxygen system is used as the ventilation gas source.

114. The method of claim 102, wherein a compressed oxygen gas source is used as the ventilation gas source.

115. The method of claim 102, wherein an oxygen generating system is used as the ventilation gas source.

116. The method of claim 102, wherein a supply volume of oxygen rich gas is integrated into the ventilator.

117. The method of claim 102, wherein the ventilation gas is delivered after the inspiratory flow rate reaches its peak amplitude.

118. The method of claim 102, wherein the ventilation gas is delivered after the respiratory muscles reach their maximum work.

119. The method of claim 102, wherein the ventilation gas is delivered in multiple pulses during inspiration.

120. The method of claim 102, wherein the ventilation gas is delivery is adjustable to occur at any time within the inspiratory phase, depending on the comfort and ventilatory needs of the patient, wherein the time in the inspiratory phase is determined by information from the breath sensor.

121. The method of claim 120, wherein the adjustment is made automatically by a physiological feedback mechanism.

122. The method of claim 121, wherein the feedback mechanism is based on airway gas concentrations.

123. The method of claim 121, wherein the feedback mechanism is based on depth of breathing.

124. The method of claim 121, wherein the feedback mechanism is based on rate of breathing.

125. The method of claim 121, wherein the feedback mechanism is based on pulse oximetry.

126. The method of claim 120, wherein the adjustment is made manually by the user.

127. The method of claim 120, wherein the adjustment is made by the patient.

128. The method of claim 120, wherein the adjustment is made by the clinician.

129. The method of claim 102, wherein in addition to the primary ventilation gas delivery, a delivery of secondary ventilation gas comprising a lower gas flow rate compared to the primary ventilation gas delivery, is delivered.

130. The method of claim 129, wherein the secondary ventilation gas is delivered early in inspiration.

131. The method of claim 129, wherein the secondary ventilation gas is delivered throughout inspiration.

132. The method of claim 129, wherein the secondary ventilation gas is delivered during exhalation.

133. The method of claim 129, wherein the secondary ventilation gas displaces CO2 in the upper airway, such that the primary ventilation gas when delivered entrains air from the upper airway into the lower airways, wherein the entrained air is low in CO2, at least 2% lower in CO2 compared to when the secondary ventilation gas is turned off.

134. The method of claim 129, wherein the secondary ventilation gas comprises a high oxygen concentration, such as 50%-100%, and the primary ventilation gas comprises a lower oxygen concentration, such as 21%-60%.

135. The method of claim 102, wherein the pressure or flow rate amplitude of the ventilation gas delivery is adjustable.

136. The method of claim 102, wherein the ventilation gas delivery pressure of flow rate waveform is shaped into a desired waveform, such as a sine wave, an ascending wave, a descending wave or a square wave.

137. The method of claim 102, wherein in addition to the primary ventilation gas delivery, gas is delivered into the airway during exhalation to provide a counter-resistance to exhaled flow, wherein the counter-resistance gas flow dynamics are selected to reduce airway collapse.

138. The method of claim 137, wherein the counter-resistance gas delivery occurs at a strategic time within the expiratory phase, for example early in exhalation or late in exhalation.

139. The method of claim 137, wherein the counter-resistance gas delivery occurs throughout exhalation.

140. The method of claim 137, wherein the counter-resistance gas delivery dynamics are oscillatory.

141. The method of claim 137, wherein the counter-resistance gas delivery dynamics are turbulent.

142. The method of claim 137, wherein the counter-resistance gas delivery dynamics are laminar.

143. The method of claim 137, wherein the counter-resistance gas delivery dynamics create a substantially uniform velocity profile in the airway.

144. The method of claim 137, wherein the counter-resistance gas delivery dynamics create a substantially non-uniform velocity profile in the airway.

145. The method of claim 102, wherein in addition to the primary ventilation gas delivery, airway gas is actively removed from the airway to reduce the CO2 content of gas in the airway.

146. The method of claim 102, wherein the ventilation gas may comprise oxygen, or helium-oxygen mixtures, or nitric oxide mixtures.

147. The method of claim 102, wherein a medicant is delivered to the patient during.

148. The method of claim 102, further comprising in addition one or more of the conjunctive therapies:

(a) a secondary gas delivery;

(b) a delivery of gas during exhalation to cause exhaled flow counter-resistance;

(c) a removal of gas from the airway;

(d) delivery of a therapeutic gas such as helium-oxygen or nitric oxide;

(e) delivery of a medication.

149. The method of claim 148, further wherein the conjunctive therapies are adjustable based on the needs of the patient, wherein the adjustment can be manual or automatic based on a feedback, and wherein the adjustment can be on or off or varying the amplitude.

150. A method for providing ventilatory assistance to a patient wherein a gas volume is delivered to the airway via a tubing in communication with the airway and wherein:

(a) the volume is delivered at a rate in synchrony with the patient'"'"'s spontaneous breathing and delivered during the patient'"'"'s inspiratory phase;

(b) the volume delivered is 5-50% of the patient'"'"'s natural tidal volume;

(c) the driving pressure in the tubing is 5-25 psi, the peak flow rate of gas delivery 12-50 liters per minute;

(d) the gas delivery time is 0.1 to 0.8 seconds;

(e) the exit speed of gas out of the tip is 25-400 meters per second causing 25-200% volume entrainment; and

(f) the ventilator is synchronized with the patient'"'"'s breathing pattern by using a breath sensor in communication with the airway of the patient to measure tracheal airflow.