Title:
Portable drag compressor powered mechanical ventilator
Document Type and Number:
Kind Code:
A1

Abstract:
A ventilator device and system comprising a rotating compressor, preferably a drag compressor, which, at the beginning of each inspiratory ventilation phase, is accelerated to a sufficient speed to deliver the desired inspiratory gas flow, and is subsequently stopped or decelerated to a basal flow level to permit the expiratory ventilation phase to occur. The ventilator device is small and light weight enough to be utilized in portable applications. The ventilator device is power efficient enough to operate for extended periods of time on internal or external batteries. Also provided is an oxygen blending apparatus which utilizes solenoid valves having specific orifice sizes for blending desired amounts of oxygen into the inspiratory gas flow. Also provided is an exhalation valve having an exhalation flow transducer which incorporates a radio frequency data base to provide an attendant controller with specific calibration information for the exhalation flow transducer.
Inventors:
Devries, Douglas F. (Yucaipa, CA, US)
Cegielski, Michael J. (Norco, CA, US)
Warner V Jr., Graves (Hemet, CA, US)
Williams, Malcolm R. (San Clemente, CA, US)
Holmes, Michael B. (Riverside, CA, US)
      Plaque It!

Sponsored by:
Flash of Genius
Application Number:
10/458211
Publication Date:
12/18/2003
Filing Date:
06/10/2003
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Primary Class:
International Classes:
(IPC1-7): A61M016/00
Attorney, Agent or Firm:
STETINA BRUNDA GARRED & BRUCKER,Kit M. Stetina (Suite 250, Aliso Viejo, CA, 92656, US)
Claims:

What is claimed is:



1. A rotary drag compressor ventilator device for ventilating the lungs of a mammalian patient, said device comprising: A. a rotary drag compressor comprising: i. a housing having a gas inflow passageway and a gas outflow passageway; ii. a rotor mounted within said housing, said rotor having a multiplicity of blades formed circularly therearound such that, when said rotor is rotated in a first direction, said blades will compress gas within said housing and expel said compressed gas out of said outflow passageway; iii. a motor coupled to said compressor for rotating said rotor within said compressor housing; and B. a controller apparatus to intermittently accelerate and decelerate the rotation of said rotor so as to deliver discrete periods of inspiratory gas flow through said outflow passageway.

2. The ventilator of claim 1, further in combination with: C. an oxygen blending apparatus connected to said inflow passageway for blending oxygen with ambient air to provide oxygen-enriched air to the inlet aperture of said compressor housing.

3. The ventilator of claim 2 wherein said oxygen blending apparatus comprises: an ambient air receiving passageway; an oxygen receiving passageway; an accumulator for receiving ambient air through said ambient air passageway and oxygen through said oxygen passageway; and, a series of independently actuatable solenoid valves positioned, in parallel, within the oxygen receiving passageway of said bending apparatus, each of said solenoid valves having a predetermined flow rate when fully open, each of said solenoid valves thereby permitting passage therethrough of a predetermined amount of oxygen per time period; and, said oxygen blending apparatus being connected to said controller and said controller being further programmable to receive input of a desired oxygen concentration setting and to emit control signals to the solenoid valves to cause individual opening and closing of said solenoid valves to result in said desired oxygen concentration within said accumulator.

4. The ventilator system of claim 3 wherein said solenoid valves comprises three to five separate solenoid valves.

5. The ventilator system of claim 3 wherein said controller is programmed to apply a pulse-width modulation signal to control the opening and closing of said solenoid valves.

6. The ventilator of claim 1 wherein said controller comprises at least one microprocessor.

7. The ventilator of claim 1 wherein said compressor rotor comprises a dual-faced compressor rotor having first and second series of blades mounted opposite sides thereof; and, wherein said compressor housing is configured to define first and second compressor flow paths which are positioned in relation to said first and second series of blades, respectively, such that rotation of said compressor rotor in said first direction will a) draw gas into said inflow passageway, b) concomitantly compress and move gas through both of said first and second flow paths and, c) expel the combined gas from said first and second compressor flow paths to compressor flow paths to provide inspiratory gas flow from said ventilator device.

8. The ventilator of claim 7 wherein said compressor rotor is round in configuration and has a diameter of 2-6 inches.

9. The ventilator of claim 7 wherein said blades are disposed at angles of attack of 30-60 degrees.

10. The ventilator of claim 9 wherein said blades are disposed at 55° angles of attack.

11. The compressor of claim 7 wherein said blades are mounted within concave annular troughs formed on opposite sides of said dual-faced compressor rotor and wherein said first and second compressor flow paths are formed in relation to said first and second annular troughs such that the series of blades mounted within the first annular trough will compress gas within said first compressor flow path and the series of blades mounted within said second trough will compress gas within said second compressor flow path.

12. The ventilator of claim 7 wherein rotor, including said blades, had a mass of less than 40 grams.

13. The ventilator of claim 7 wherein said rotor further comprises: the convex rotor hub having a central transverse motor shaft receiving aperture formed therein, to facilitate rotation of said rotor by said motor.

14. The ventilator of claim 7 wherein said rotor is formed of molded material.

15. The ventilator of claim 7 wherein said blades are formed of aluminum.

16. The ventilator of claim 7 wherein approximately 30-40 blades are positioned on either side of said rotor.

17. The ventilator of claim 1 further comprising: a differential pressure transducer for measuring the difference in pressure between gas entering the inlet of said compressor and gas exiting the outlet of said compressor.

18. The ventilator of claim 1 further comprising: a tachometer for measuring the rotational speed of said compressor.

19. The ventilator of claim 18 wherein said tachometer comprises an optical encoder.

20. The ventilator of claim 1 further comprising: a differential pressure transducer for measuring the difference in pressure between gas entering the inlet of said compressor and gas entering the outlet of said compressor; a tachometer for measuring the rotational speed of said compressor; and said differential pressure transducer and said tachometer being in communication with said controller; and said controller being programmed to determine the instantaneous flow rate and current accumulated volume of inspiratory gas flow delivered by said ventilator based on the pressure differential measured by said differential pressure transducer and the rotational speed measured by said tachometer.

21. The ventilator of claim 1 wherein said compressor incorporates a controller-readable data base containing specific rotational speed, differential pressure and flow rate data for that particular compressor; and wherein said controller is further programmed to read said data base and to utilize information obtained from said data base in the calculation of inspiratory flow, volume or pressure delivered by said ventilator.

22. The ventilator of claim 21 wherein said controller-readable data base comprises an EPROM.

23. The ventilator of claim 1 further in combination with a portable battery for supplying power to said device.

24. The ventilator of claim 23 wherein said portable battery contains sufficient power to operate said mechanical ventilator device for at least two hours.

25. A drag compressor apparatus for creating inspiratory gas flow in a mechanical ventilator, said compressor apparatus comprising: a housing having a gas inflow passageway and a gas outflow passageway; a rotor rotatably mounted within said housing, said rotor being configured and constructed such that rotation of said rotor in a first direction will cause said rotor to a) draw gas in said inflow passageway, b) compress said gas and c) expel said gas out of said outflow passageway; a controller for controlling the rotation of said rotor within said housing, said controller being operative to cause said rotor to intermittently accelerate and decelerate so as to deliver discrete periods of inspiratory gas flow through said outflow passageway.

26. The compressor of claim 25 wherein said rotor incorporates at least one series of blades having leading edges, each of said blades being disposed at a positive angle of attack such that, when said rotor is rotated in said first direction, the leading edge of each blade will precede the remainder thereof.

27. The compressor of claim 26 wherein said blades are disposed at angles of attack of 30-60 degrees.

28. The compressor of claim 27 wherein said blades are disposed at 55 degree angles of attack.

29. The compressor of claim 26 wherein said blades are disposed at spaced intervals within an annular trough which extends about said rotor such that, when said rotor is rotating said first direction, said blades will serially contact and compress gas within said housing.

30. The compressor of claim 29 wherein said housing is further configured to define therewithin at least one compressor flow path said flow path being positioned in relation to said annular trough and being connected to said inflow and outflow passageways such that, when said rotor is rotated in said first direction, the blades of said rotor will a) draw gas inwardly through said inflow passageway into said compressor flow path, b) compress said gas within said compressor flow path, and c) expel said gas out of said outflow passageway.

31. The compressor of claim 31 wherein each of said blades has a leading edge and at least one peripheral edge, and wherein said blades are mounted within said trough such that the leading edges of the blades extend transversely across the trough and the peripheral edge of said blades are in abutment with said trough.

32. The compressor of claim 30 wherein said at least one concave annular trough comprises: a first annular trough which extends about the periphery of said rotor on a first side thereof; and, a second annular trough which extends about the periphery of said rotor on a second side thereof.

33. The compressor of claim 32 wherein said housing is configured to define therewithin: a first compressor flow path which is at least partially within said first annular trough and is connected to said inflow passageway and said outflow passageway; and, a second compressor flow path which is at least partially within said second annular trough and is connected to said inflow passageway and said outflow passageway; said first and second compressor flow paths being configured and positioned such that, when said rotor is rotated in said first direction, the blades mounted within said first annular trough will draw gas into said inflow passageway, compress said gas within said first flow path, and expel said gas out of said outflow passageway and the blades mounted within said second annular trough will draw gas into said inflow passageway, compress sid gas within said second flow path, and expel said gas out of said outflow passageway.

34. The compressor of claim 33 wherein said first concave trough and the blades mounted therewithin are mirror images of said second concave trough and the blades mounted therewithin.

35. The compressor of claim 25 further comprising a drive motor located within said compressor housing and coupled to said rotor to rotatably drive said rotor.

36. The compressor of claim 25 wherein said housing further comprises a number of heat dissipation fins formed on the outside of the portion of said housing wherein said motor is positioned to facilitate dissipation of heat from said motor.

37. The compressor of claim 35 further comprising a tachometer for measuring the rotational speed of said rotor.

38. The compressor of claim 37 wherein said tachometer comprises an optical encoder.

40. The compressor of claim 25 further comprising: a differential pressure transducer for measuring the difference between the pressure of gas in said inflow passageway and the pressure of gas in said outflow passageway.

41. An exhalation valve for controlling the expiratory gas flow from a mammalian patient, said exhalation valve comprising: a housing defining an expiratory gas flow passageway therethrough; a valve seat formed within said expiratory gas flow passageway; an annular diaphragm movably disposed within said gas flow passageway, in juxtaposition to said valve seat, said diaphragm being variably movable back and forth to various positions between and including: i) a fully closed position wherein said diaphragm is firmly seated against said valve seat to prevent gas from flowing through said passageway; and ii) a fully open position wherein said diaphragm is retracted away from said annular valve seat so as to permit substantially unrestricted flow of expiratory gas through said pathway; an elongate actuation shaft having a proximal end and a distal end, the distal end of said actuation shaft being contractable with said diaphragm, and said actuation shaft being axially moveable back and forth to control the positioning of said diaphragm between said fully closed and said fully open positions; an electrical induction coil linked to said actuation shaft such that a decrease in the current passing into said induction coil will cause said shaft to advance in the distal direction and an increase in the current passing into said induction coil will cause said shaft to retract in the proximal direction; means for determining the flow rate of expiratory gas passing out of said exhalation valve; means for determining airway pressure; a microprocessor controller connected to said means for determining airway pressure, said controller being provided with a positive expiratory pressure setting, and said controller being connected to said induction coil and adapted to emit control signals to said induction coil to control the movement of said actuation shaft in response to the current airway pressure, thereby maintaining the present amount of positive expiratory pressure; a radio frequency transponder database containing flow characterization data for the means for determining the flow rate of expiratory gas passing out of said exhalation valve; said controller being further connected to said means for determining the flow rate of expiratory gas passing out of said exhalation valve and being equipped to receive radio frequency input of the characterization data contained in the radio frequency transponder database, and to utilize such data to determine the instant flow rate of expiratory gas passing out of said exhalation valve.

43. The exhalation valve of claim 42 wherein said controller is located separately from, said exhalation valve.

44. The exhalation valve of claim 41 wherein said controller is further adapted to receive input signals from said means for determining the flow rate at which expiratory gas is passing outwardly through said expiratory gas flow passageway, and for emitting control signals to said induction coil to fully close said diaphragm when said flow rate has fallen to a predetermined basal level, thus signifying the end of the expiratory phase.

45. A method of providing pulmonary ventilation to a mammalian patient, said method comprising the steps of: a) providing a rotary drag compressor device comprising: i) a housing having an inflow passageway and an outflow passageway formed therein; and, ii) a rotor rotatably mounted within said housing such that rotation of said rotor in a first direction will draw gas into said inflow passageway, compress said gas, and expel said gas out of said outflow passageway; b) connecting the outflow passageway of said rotary drag compressor to a conduit through which respiratory gas flow may be passed into the patient's lungs; c) accelerating said rotor to a first rotational speed for sufficient time to deliver a desired inspiratory gas flow through said conduit and into the patient's lungs; d) stopping said rotor or decelerating said rotor to a basal rotational speed to terminate the inspiratory gas flow through said conduit and to allow the expiratory phase of the ventilation cycle to occur.

46. The method of claim 45 wherein step b comprises connecting said overflow passageway to an endotracheal tube inserted into the trachea of the patient.

47. The method of claim 45 wherein step b comprises connecting said outflow passageway to a nasotracheal tube inserted into the trachea of the patient.

48. The method of claim 45 wherein step b comprises connecting said outflow passageway to a tracheostomy tube inserted into the trachea of the patient.

49. The method of claim 45 wherein step b comprises connecting said outflow passageway to a mask which is positioned over the nose and mouth of the patient.

50. The method of claim 45 wherein step c is commenced upon the occurrence of a triggering event, said triggering event being selected from the group of triggering events consisting of: i) the passing of a predetermined time period; and ii) the initiation of spontaneous inspiratory effort by the patient.

51. The method of claim 45 wherein the inspiratory gas flow delivered in step c is limited by a limiting parameter selected from the group of limiting parameters consisting of: i. a predetermined minimum airway pressure; ii. a predetermined maximum airway pressure; iii. a predetermined minimum flow rate; iv. a predetermined maximum flow rate; v. a predetermined minimum tidal volume; and vi. a predetermined maximum tidal volume.

52. The method of claim 45 wherein step c is terminated and step d is commenced upon the occurrence of a selected terminating event, said terminating event being selected from the group of terminating events consisting of: i. the passing of a predetermined period of time since the commencement of step c; ii. the attainment of a predetermined airway pressure; and iii. the passage of a predetermined tidal volume of inspiratory gas.

53. The method of claim 45 wherein step c further comprises controlling the speed to which said rotor is accelerated during the inspiratory phase by: i. storing specific rotor speed, compressor differential pressure and flow rate characterization data for the compressor; ii. providing a first input signal to said compressor which is intended to cause the rotor to rotate at a speed calculated to deliver a desired flow rate; iii. determining the actual flow rate generated by said compressor in response to said first input signal; iv. comparing the actual flow rate determined in step iii, to the desired flow rate; v. adjusting the input signal to said compressor to provide the desired flow rate.

54. The method of claim 53 wherein step c further comprises: vi. repeating steps ii-v, as necessary to achieve said desired flow rate.

55. A rotary drag compressor ventilator device for delivering inspiratory gas flow to a mammalian patient, said device comprising: a) a rotary drag compressor having an intake port and an outflow port; b) an inspiratory gas flow passageway for carrying gas from the outflow port of the compressor to the patient during the inspiratory phase of the ventilation cycle; c) means for accelerating said compressor at the beginning of the inspiratory phase of the ventilation cycle to deliver inspiratory gas flow through said passageway to said patient; d) means for controlling said compressor during the inspiratory phase of the ventilation cycle to maintain a desired inspiratory pressure and flow rate; and, e) means for decelerating said compressor at the end of the inspiratory phase of the ventilation cycle.

56. The ventilator device of claim 55 wherein said inspiratory gas flow passageway is devoid of valves for diverting the inspiratory gas flow away from said patient.

57. The ventilator device of claim 55 wherein said rotary drag compressor comprises: a compressor housing having said intake and outflow ports formed therein; a rotor mounted within said housing such that rotation of said rotor in a first direction will cause said inspiratory gas flow to be delivered out of said outflow port and through said inspiratory gas flow passageway to said patient; and, a motor for rotating said rotor within said housing.

58. The ventilator device of claim 55 wherein said means for accelerating, controlling and decelerating said compressor comprise: a microprocessor controller connected to said compressor.

59. The ventilator device of claim 55 further comprising: f) an exhalation conduit for carrying expiratory gas flow from said patient during the expiratory phase of the ventilation cycle; g) an exhalation valve positioned on said exhalation conduit, said exhalation valve being constructed to: i) open during the expiratory phase of the ventilation cycle to permit the expiratory gas flow to pass out of said exhalation conduit, and ii) close during the inspiratory phase of the ventilation cycle to prevent gas from being drawn into said patient through said exhalation conduit.

60. The ventilator device of claim 55 further comprising: f) an oxygen blending apparatus connected to said intake port to provide oxygen-enriched air to said compressor.

61. An exhalation valve comprising: a) a housing defining a first exhalation passageway through which expiratory gas may outflow in a first direction; b) a valve seat formed within said passageway; c) a diaphragm having a front side and a back side, said diaphragm being sized and configured such that the front side thereof may abut against said valve seat valve seat to thereby block the flow of gas through said exhalation passageway, said diaphragm being moveable back and forth between; i) a first position wherein said diaphragm is fully retracted from said valve seat to permit unrestricted flow through said passageway; ii) a second position wherein said diaphragm is seated on said valve seat to block flow through said passageway; iii) a range of intermediate positions between said first and second positions wherein said diaphragm will cause varying degrees of restriction of the flow through said passageway; d) an elongate shaft having a first end and a second end, the first end of said shaft being adjacent to the back side of said diaphragm, said shaft being axially moveable back and forth between; i) a first position wherein the first end of said shaft is at a location which will retain said diaphragm in its first position; ii) a second position wherein the first and of said shaft is at a location which will allow said diaphragm to move to its second position; and, iii) a range of intermediate positions wherein said shaft is at a location which will allow said diaphragm to move to one of its intermediate positions; e) an electrical induction coil slidably mounted within said housing so as to move back and forth in response to changes in current applied to the coil, said coil consisting essentially of multiple convolutions of wire upon which a rigidifying coating has been applied to hold said wire in a closely coiled substantially cylindrical configuration; f) a mounting spider connecting said shaft to said coil, said spider configured to hold said shaft in co-axial alignment with the longitudinal axis of the coil, with the first end of the shaft protruding toward the back side of said diaphragm such that, when the coil moves forward, said shaft will move forward toward said first shaft position, and when said coil moves rearward, said shaft will be retracted toward said second shaft position.

62. The exhalation valve of claim 61 wherein the front surface of said diaphragm is planar and wherein said valve seat is angled relative to the plane of the front surface of the diaphragm such that, when said diaphragm is moving into said first diaphragm position, the front side of said diaphragm will initially contact only one side of said diaphragm and will subsequently move into contact with the remainder of said valve seat.

63. The exhalation valve of claim 61 further comprising: g) a pliable dust barrier disposed between said valve seat and said induction coil, said pliable dust barrier being sealed to the surrounding housing to prevent particulate matter from passing around said shaft and into said induction coil, said dust barrier being in contact with said shaft and being sufficiently flexible to move back and forth in accordance with axial movement of said shaft.

64. The exhalation valve of claim 63 wherein said dust barrier comprises an elastomeric boot.

65. The exhalation valve of claim 63 wherein at least one vent hole is formed in said exhalation valve to prevent the creation of pressure on at least one side of said dust barrier as said dust barrier flexes back and forth.

66. An exhalation valve comprising: a) a housing defining an expiratory gas flow path connectable to a mammalian patient such that expiratory gas exhaled by the patient will pass through said flow path in a first direction; b) a valve associated with said flow path to permit gas exhaled by the patient to pass through said flow path in said first direction, but to prevent gas from being drawn through said flow path, in a second direction opposite said first direction, when said patient inhales; c) a flow measuring apparatus for monitoring the flow rate of expiratory gas passing through said exhalation valve.

67. The exhalation valve of claim 66 wherein said flow measuring apparatus comprises: a flapper disposed transversely within said flow path, said flapper being constructed such that at least a portion of said flapper will deflect in a first direction when exhaled gas is passed through said flow path in said first direction, the extent of flapper deflection being variable with the flow rate of gas passing through the exhalation valve, said flapper thereby creating a dynamic flow restricting orifice within said flow path; means for determining gas pressure within said flow path upstream of said flapper; means for determining gas pressure within said flow path downstream of said flapper; and means for determining the then-current flow rate of gas passing through said exhalation valve, based on the difference in the pressures measured upstream and downstream of said flapper.

68. The exhalation valve device of claim 72 wherein said flapper is mounted within a flapper assembly which comprises: a sheet of pliable material having a first side, a second side and an outer peripheral edge, a semi-annular cut being formed in said sheet to divide said sheet into i) an outer peripheral portion which is outboard of said cut and ii) an inner flapper portion which is inboard of said cut, and which remains attached on one side thereof to the surrounding peripheral portion of said sheet, said inner flapper portion of said sheet being thereby deflectable back and forth while the outer peripheral portion of said sheet is held in substantially stationary position; a first frame member having a central aperture formed therein, said first frame member being juxtaposed to the first side of said sheet such that said first frame member is in contact with the first side of the peripheral portion of said sheet such that said first frame member is in abutment with the first side of the peripheral portion of said sheet and the central aperture of said first frame member surrounds the first side of the flapper portion of said sheet; a second frame member having a central aperture formed therein, said second frame member being juxtaposed to the second side of said sheet such that said frame member abuts against the second side of the peripheral portion of said sheet, and the central aperture of said second frame member surrounds the second side of the flapper portion of said sheet; said first and second frame members thereby holding the peripheral portion of said sheet in a substantially fixed position between said frame members while the flapper portion of said sheet extends transversely into the space between the axially aligned apertures of said frame members and is deflectable back and forth therein.

69. The exhalation valve device of claim 68 wherein said flapper assembly is positioned transversely within the flow path of said exhalation valve and is held in such position by engagement to the surrounding exhalation valve housing.

70. The exhalation valve device of claim 66 further comprising: specific flow-pressure calibration information for the flow measuring apparatus stored on a storage medium contained within the exhalation valve housing.

71. The exhalation valve device of claim 70 wherein said storage medium comprises a radio-frequency transponder.

72. The exhalation valve device of claim 70 wherein the characterization information stored on said storage medium comprises a data base of predetermined pressure differences for specific flow rates of exhalation valve.

73. The exhalation valve device of claim 70 wherein the information stored on said storage medium comprises an equation for calculating specific flow rates based on measured pressure differentials for that exhalation valve.

74. The exhalation valve device of claim 68 further comprising: a cushioning washer and a third frame member disposed on at least one of the first and second frame members which abut against the same so as to evenly distribute stresses applied to said sheet by said frame members.

75. The exhalation valve device of claim 74 wherein said cushioning washer comprises an elastomeric material disposed on said third frame member.

76. An oxygen blending apparatus for delivering oxygen enriched air to a ventilator, said apparatus comprising: a) an accumulator chamber; b) an air inlet conduit connected to said accumulator chamber; c) an oxygen inlet conduit connected to said accumulator chamber; d) a series of solenoid valves connected, in parallel, within said oxygen inlet conduit, each of said solenoid valves having a predetermined orifice size; and e) a controller for independently opening and closing each of the solenoid valves to control the amount of oxygen which flows into the accumulator chamber during a time period.

77. The oxygen blending apparatus of claim 76 further in combination with a ventilator device connected to the outlet of said accumulator chamber, said ventilator device being operative to intermittently draw inspiratory gas from said accumulator chamber to compress and expel said gas to provide an inspiratory flow.

78. The oxygen blending apparatus of claim 77 wherein said controller is further programmed to repeatedly determine the volume of oxygen enriched gas which has been drawn from the accumulator chamber during the then-current inspiratory phase, and to subsequently adjust the opening and closing of the solenoid valves to maintain the prescribed oxygen concentration of gas drawn from the accumulator chamber during the reminder of that inspiratory phase.

79. The oxygen blending apparatus of claim 78 wherein said controller is further programmed to repeatedly compare the then-current accumulated volume of oxygen enriched gas to a predetermined trigger volume for each of the solenoid valves, and to open each solenoid valve for a predetermined period of time when it is determined that the accumulated volume of oxygen-enriched air has exceeded the trigger volume for that individual solenoid valve.

80. The oxygen blending apparatus of claim 76 wherein said solenoid valves comprise at least first, second, third and fourth solenoid valves, and wherein a predetermined oxygen pressure is constantly passed into said oxygen inlet conduit.

81. The oxygen blending apparatus of claim 80 wherein said first, second, third, and fourth solenoid valves have flow rates, at a predetermined oxygen inlet operating pressure, of 5 liters/min., 14.7 liters/min.; 40 liters/min. and 80 liters/min., respectively.

82. The oxygen blending apparatus of claim 76 wherein the ventilator device connected to the outlet of the accumulator chamber comprises the ventilator device of claim 55.

83. The oxygen blending apparatus of claim 82 wherein the controller which controls opening and closing of the solenoid valves is incorporated into the means for controlling the ventilator compressor.

84. A flow transducer for measuring the flow rate of a fluid, said transducer comprising: a housing defining a first fluid flow path therethrough; a deflectable flapper disposed transversely within said fluid flow path such that said flapper will deflect in the direction of fluid flow, thereby creating a fluid flow restriction permitting some fluid to flow past said flapper and through said flow path; a first pressure port located upstream of said flapper for measuring the pressure of fluid within said flow path, upstream of said flapper; a second pressure port downstream of said flapper for measuring the pressure of fluid flowing through said flow path, downstream of said flapper; means associated with first pressure port for determining the pressure of fluid flowing upstream of said flapper; means associated with said second pressure port for determining the pressure of fluid flowing downstream of said flapper; means for determining the difference between the pressure of fluid flowing upstream of said flapper and the pressure of fluid flowing downstream of said flapper; and means for computing the flow rate of fluid through said flow path, based on the measured difference in pressures upstream and downstream of said flapper.

85. The fluid flow transducer of claim 84, wherein said deflectable flapper comprises: a rigid frame having a central aperture formed therein; a flat sheet of pliable material mounted within said frame member and forming a flapper disposed transversely within the central aperture of said frame and deflectable in at least one direction to permit fluid to flow past said flapper and through said central aperture; said frame being mounted transversely within said flow path such that fluid flowing in a first direction through said flow path will strike said flapper, thereby causing said flapper to deflect in the direction of flow such that the flowing fluid may pass through said central aperture.

86. The flow transducer of claim 85 wherein: said flat sheet of pliable material comprises an outer peripheral portion, an inner flapper portion, and a semi-annular cut formed in said sheet to free most of said peripheral portion from said flapper portion; and said rigid frame comprises first and second frame members disposed on opposite sides of the peripheral portion of said flat sheet, said frame members being compressed inwardly to compressively hold said peripheral portion of said flat sheet between said frame members such that the flapper portion of said flat sheet is transversely disposed and deflectable within the central aperture of said frame.

87. The flow transducer of claim 84 further comprising: a cushioning member associated with said flapper to distribute the force exerted on said flapper thereby distributing any stresses created within said flapper.

88. The flow transducer of claim 85 further comprising: a cushioning member associated with said frame to distribute the force exerted by said frame on said flat sheet of pliable material, thereby distributing any stresses of created within said flat sheet of pliable material.

89. The flow transducer of claim 84 wherein said housing comprises a portion of an exhalation valve through which a mammalian patient is permitted to exhale, said flow transducer being disposed within said exhaltion valve to measure the flow rate of expiratory gas passing through said exhalation valve.

90. The flow transducer of claim 84 further comprising: a deflector member positioned on at least one of said first and second pressure ports to deter fluid from being forced directly into the pressure port on which deflector insert is positioned.

91. The flow transducer of claim 84 wherein said means for computing flow rate comprises a microprocessor.

92. The flow transducer of claim 86 wherein: said housing incorporates first and second abutment ridges formed about-said flow path; said first and second frame members, having said flat sheet of pliable material therebetween, being positioned between said abutment ridges such that said abutment ridges will exert inward compressive force on said first and second frame members to compressively hold said flat sheet therebetween.

93. The flow transducer of claim 84 further comprising: specific flow-pressure calibration information for the flow transducer stored on a storage medium contained within said housing.

94. The flow transducer of claim 93 wherein said storage medium comprises a radio-frequency transponder.

95. The flow transducer of claim 93 wherein the specific flow-pressure calibration information stored on said storage medium comprises a data base of predetermined pressure differences for specific flow rates of fluid through said flow path.

96. The flow transducer of claim 93 wherein the calibration information stored on said storage medium comprises an equation for calculating specific flow rates based on measured differences in pressure upstream and downstream of said flapper.

Description:

FIELD OF THE INVENTION

[0001] The present invention pertains generally to medical equipment and more particularly to a compressor powered mechanical ventilator device for delivering respiratory ventilation to a mammalian patient.

BACKGROUND OF THE INVENTION

A. Principles of Mechanical Ventilation

[0002] In many clinical settings mechanical ventilators are used to facilitate the respiratory flow of gas into and out of the lungs of patients who are sick, injured or anesthetized.

[0003] In general, mechanical ventilators provide a repetitive cycling of ventilatory flow, each such repetitive cycle being separated into two phases—an inspiratory phase followed by an expiratory phase.

[0004] The inspiratory phase of the ventilator cycle is characterized by the movement of positive-pressure inspiratory flow of gas through the ventilator circuit and into the lungs of the patient. The expiratory phase of the ventilatory cycle is characterized by cessation of the positive pressure inspiratory flow long enough to allow lung deflation to occur. The exhaled gas is vented from the ventilator circuit, typically through an exhalation valve. In patient whose lungs and thoracic musculature exhibit normal compliance, the act of exhalation is usually permitted to occur spontaneously without mechanical assistance from the ventilator.

[0005] It is sometimes desirable to control the airway pressure during exhalation to maintain a predetermined amount of positive back pressure during all, or a portion of, the respiratory cycle. Such techniques are often utilized to treat impairments of lung capacity due to pulmonary atelectasis or other factors.

[0006] The mechanical ventilators of the prior art have been grouped under various classification schemes, based on various criteria. In general, mechanical ventilators may be grouped or classified according to the parameter(s) which are utilized for a) triggering, b) limiting and c) terminating (e.g., cycling) the inspiratory phase of the ventilator cycle.

[0007] “Triggering” is the action that initiates the inspiratory phase of the ventilator cycle. The initiation of the inspiratory phase may be triggered by the ventilator or the patient. The variables and/or parameters which are utilized to trigger the beginning of the inspiratory phase include: time (i.e., respiratory rate), the commencement of spontaneous inhalation by the patient and/or combinations thereof.

[0008] “Limiting” of the inspiratory phase refers to the manner in which the inspiratory gas flow is maintained within prescribed ranges to optimize the ventilation of the patient's lungs. The limiting variables and/or parameters are typically controlled by the ventilator, but may change as a result of patient effort and/or physiologic variables such as lung compliance and airway resistance. The variables and/or parameters which are utilized for limiting the inspiratory phase include flow rate, airway pressure and delivered volume.

[0009] “Terminating” or “cycling” of the inspiratory phase of the ventilator cycle refers to the point at which the inspiratory flow is stopped and the ventilator and/or patient are permitted to “cycle” into the expiratory phase. Depending on the ventilator control settings, the termination of the inspiratory phase may be brought about by the ventilator or the patient. The variables and/or parameters which are utilized to terminate the inspiratory phase include: time; peak airway pressure; and/or tidal volume (V t ).

B. Mechanical Ventilation Modes Utilized in Modern Clinical Practice

[0010] In addition Mechanical ventilators are utilized to deliver various “modes” of mechanical ventilation, the particular mode of ventilation being selected or prescribed based on the clinical condition of the patient and the overall objective (i.e., long term ventilation, short term ventilation, weaning from ventilator, etc . . . ) of the mechanical ventilation.

I. Ventilation Modes

[0011] i. Intermittent Mandatory Ventilation (IMV)

[0012] Intermittent Mandatory Ventilation is a ventilation mode wherein a spontaneously breathing patient receives intermittent mechanical inflation supplied asynchronously by the ventilator.

[0013] ii. Synchronized Intermittent Mandatory Ventilation (SMIV)

[0014] Synchronized Intermittent Mandatory Ventilation is a ventilation mode wherein a spontaneously breathing patient receives occasional mandatory ventilatory breaths. Mandatory ventilator breaths are synchronized with the patient's spontaneous inspiratory efforts.

[0015] iii. Controlled Mechanical Ventilation (CMV)

[0016] Controlled Mechanical Ventilation (CMV) is a ventilation mode wherein mechanical breaths are delivered to the patient at time intervals which are unaffected by patient efforts. Controlled Mechanical Ventilation is typically utilized in patients who are not breathing spontaneously.

[0017] iv. Assist/Control Ventilation (A/C)

[0018] Assist/Control Ventilation (A/C) is a ventilation mode wherein the patient is able to volitionally alter the frequency of mandatory ventilator breaths received, but can not alter the flow and title volume (V t ) of each ventilator breath received. Controlled, mandatory breaths are initiated by the ventilator based on the set breath rate. In addition, the patient can demand and trigger an assist breath. After successful triggering of an assist breath, the exhalation valve is closed and gas is delivered to the patient to satisfy the preset tidal volume, peak flow and wave form.

C. Breath Types Utilized in Modern Clinical Practice

[0019] Breath types are typically classified according to the particular functions which control:

[0020] a) triggering;

[0021] by) limiting; and

[0022] c) cycling of each breath delivered by the mechanical ventilator, as described and defined hereabove.

[0023] Typical breath types and ventilator parameters utilized in modern clinical practice include the following:

[0024] i. Machine-Cycled—Mandatory Breath

[0025] A machine-cycled, mandatory breath is a breath that is triggered, limited and cycled by the ventilator.

[0026] ii. Machine-Cycled—Assist Breath

[0027] A machine cycled assist breath is a breath that is triggered by the patient, but is limited and cycled by the ventilator.

[0028] iii. Patient-Cycled—Supported Breath

[0029] A patient-cycled, supported breath is a breath that is triggered by the patient, limited by the ventilator, and cycled by the patient.

[0030] iv. Patient-Cycled—Spontaneous Breath

[0031] A patient-cycled spontaneous breath is a breath that is triggered, limited and cycled by the patient. While patient effort limits the flow, and hence the inspiratory volume of the breath, the ventilator may also limit the breath by providing a flow that is to low to maintain a constant pressure in the face of patient inspiratory demand.

[0032] v. Volume-Controlled Mandatory Breaths

[0033] Volume-controlled breaths are machine-triggered mandatory breaths. The inspiratory phase is initiated by the ventilatory based on a preset breath rate. The inspiratory phase is ended, and the expiratory phase begun, when the breath delivery is determined to be complete based on a preset tidal volume, peak flow and wave form setting. The ventilator remains in expiratory phase until the next inspiratory phase begins.

[0034] vi. Volume-Controlled—Assist Breaths

[0035] Volume-controlled breaths are machine cycled supported breaths that are initiated by the patient. Volume-controlled assist breaths may be initiated only when the “assist window” is open. The “assist window” is the interval or time during which the ventilator is programmed to monitor inspiratory flow for the purpose of detecting patient inspiratory effort. When a ventilator breath is triggered, the inspiratory phase of such breath will continue until a preset tidal volume peak flow and wave form have been achieved. Thereafter, the exhalation valve is open to permit the expiratory phase to occur. The ventilatory remains in the expiratory phase until the next patient-triggered breath, or the next mandatory inspiratory phase, begins.

[0036] vii. Pressure-Controlled Breaths

[0037] Pressure-Controlled breaths are delivered by the ventilator using pressure as the key variable for limiting of the inspiratory phase. During pressure control, both the target pressure and the inspiratory time are set, and the tidal volume delivered by the ventilator is a function of these pressure and time settings. The actual tidal volume delivered in each pressure-controlled breath is strongly influenced by patient physiology.

[0038] viii. Pressure Support Breaths

[0039] Pressure support breaths are triggered by the patient, limited by the ventilator, and cycled by the patient. Thus, each breath is triggered by patient inspiratory effort, but once such triggering occurs the ventilator will assure that a predetermined airway pressure is maintained through the inspiratory phase. The inspiratory phase ends, and the expiratory phase commences, when the patients inspiratory flow has diminished to a preset baseline level.

[0040] ix. Sigh Breaths

[0041] A sigh breath is a machine-triggered and cycled, volume-controlled, mandatory breath, typically equal to 1.5 times the current tidal volume setting. The inspiratory phase of each sigh breath delivers a preset tidal volume and peak flow. The duration of the inspiratory phase of each sigh breath is limited to a maximum time period; typically 5.5 seconds. The ventilator may be set to deliver a sigh function automatically after a certain number of breaths or a certain time interval (typically 100 breaths for every 7 minutes), which ever interval is shorter. The sigh breath function it may be utilized during control, assist and SIMV modes of operation, and is typically disabled or not utilized in conjunction with pressure controlled breath types or continuous positive air way pressure (CPAP).

[0042] x. Proportional Assist Ventilation (PAV)

[0043] Proportional Assist Ventilation (PAV) is a type of ventilator breath wherein the ventilator simply amplifies the spontaneous inspiratory effort of the patient, while allowing the patient to remain in complete control of the tidal volume, time duration and flow pattern of each breath received.

[0044] xi. Volume Assured Pressure Support (VAPS)

[0045] Volume Assured Pressure Support (VAPS) is a type of ventilator breath wherein breath initiation and delivery is similar to a pressure support breath. Additionally, the ventilator is programmed to ensure that a preselected tidal volume (V t ) is delivered during such spontaneously initiated breath.

D. Oxygen Enrichment of the Inspiratory Flow

[0046] It is sometimes desirable for mechanical ventilators to be equipped with an oxygen-air mixing apparatus for oxygen enrichment of the inspiratory flow. Normal room air has an oxygen content (FiO 2 ) of 21%. In clinical practice, it is often times desirable to ventilate patients with oxygen FiO 2 from 21% to 100%. Thus, it is desirable for mechanical ventilators to incorporate systems for blending specific amounts of oxygen with ambient air to provide a prescribed oxygen-enriched FiO 2 . Typically, volume-cycle ventilators which utilize a volume displacement apparatus have incorporated oxygen mixing mechanisms whereby compressed oxygen is combined with ambient air to produce the selected FiO 2 as both gases are drawn into the displacement chamber during the expiratory phase of the ventilator cycle. Nonbellows-type volume-cycled ventilators have incorporated other air-oxygen blending systems for mixing the desired relative volumes of oxygen and air, and for delivering such oxygen-air mixture through the inspirations circuitry of the ventilator.

E. Regulation/Control of Expiratory Pressure

[0047] The prior art has included separately controllable exhalation valves which may be preset to exert desired patterns or amounts of expiratory back pressure, when such back pressure is desired to prevent atelectasis or to otherwise improve, the ventilation of the patient.

[0048] The following are examples of expiratory pressure modes which are frequently utilized in clinical practice:

[0049] i. Continuous Positive Airway Pressure (CPAP)

[0050] Continuous Positive Airway Pressure (CPAP) is employed during periods of spontaneous breathing by the patient. This mode of ventilation is characterized by the maintenance of a continuously positive airway pressure during both the inspiratory phase, and the expiratory phase, of the patient's spontaneous respiration cycle.

[0051] ii. Positive End Expiratory Pressure (PEEP)

[0052] In Positive End Expiratory Pressure a predetermined level of positive pressure is maintained in the airway at the end of the expiratory phase of the cycle. Typically, this is accomplished by controlling the exhalation valve so that the exhalation valve may open only until the circuit pressure has decreased to a preselected positive level, at which point the expiration valve closes again to maintain the preselected positive end expiratory pressure (PEEP).

F. Portable Ventilators of the Prior Art

[0053] The prior art has included some non-complex portable ventilators which have inherent limitations as to the number and type of variables and/or parameters which may be utilized to trigger, limit and/or terminate the ventilator cycle. Although such non-complex ventilators of the prior art are often sufficiently power efficient and small enough for portable use, their functional limitations typically render them unsuitable for long term ventilation or delivery of complex ventilation modes and or breath types.

[0054] The prior art has also included non-portable, complex microprocessor controlled ventilators of the type commonly used in hospital intensive care units. Such ventilators typically incorporate a microcomputer controller which is capable of being programmed to utilize various different variables and/or parameters for triggering, limiting and terminating the inspiratory phase of the ventilator cycle. Complex ventilators of this type are typically capable of delivering many different ventilation modes and or breath types and are selectively operable in various volume-cycled, pressure cycled or time-cycled modes. However, these complex ventilators of the prior art have typically been too large in size, and too power inefficient, for battery-driven portable use. As a result of these factors, most of the complex micro-processor controlled ventilators of the prior art are feasible for use only in hospital critical care units.

[0055] As is well known there exist numerous settings, outside of hospital critical care units, where patients could benefit from the availability of a small, battery powered, complex microprocessor controlled mechanical ventilator capable of delivering extended modes of ventilation. For example, critically ill patients sometimes require transport outside of the hospital in various transport vehicles, such as ambulances and helicopters. Also, critical care patients are sometimes transiently moved, within the hospital, from the critical care unit to various special procedure areas (e.g., radiology department, emergency room, catheterization lab etc.,) where they may undergo diagnostic or therapeutic procedures not available in the critical care unit. Additionally, patients who require long term ventilation are not always candidates for admission to acute care hospital critical care units or may be discharged to step-down units or extended care facilities. Also, some non-hospitalized patients may require continuous or intermittent ventilatory support. Many of these patients could benefit from the use of complex microprocessor controlled ventilators, but may be unable to obtain such benefit due to the non-feasibility of employing such ventilators outside of the hospital-critical care unit environment.

[0056] In view of the foregoing limitations on the usability of prior art complex microprocessor controlled volume-cycled ventilators, there exists a substantial need in the art for the development of a portable, highly efficient, ventilator capable of programmed delivery of various modern ventilatory modes and breath types, while also being capable of use outside of the hospital critical care unit environment, such as in transport vehicles, extended care facilities and patients homes, etc.

[0057] U.S. Pat. No. 4,493,614 (Chu et al.) entitled “PUMP FOR A PORTABLE VENTILATOR” describes a reciprocating piston pump which is purportedly usable in a portable ventilator operable on only internal or external battery power.

[0058] U.S. Pat. No. 4,957,107 (Sipin) entitled “GAS DELIVERY MEANS” describes a rotating drag compressor gas delivery system which is ostensibly small enough to be utilized in a portable ventilator. The system described in U.S. Pat. No. 4,957,107 utilizes a high speed rotary compressor which delivers a substantially constant flow of compressed gas. The rotary compressor does not accelerate and decelerate at the beginning and end of each inspiratory phase of the ventilator cycle. Rather, the rotating compressor runs continuously, and a diverter value is utilized to alternately direct the outflow of the compressor a) into the patients lungs during the inspiratory phase of the ventilation cycle, and b) through an exhaust pathway during the expiratory phase of the ventilation cycle.

[0059] Thus, there remains a substantial need for the development of an improved portable mechanical ventilator which incorporates the following features:

[0060] A. Capable of operating for extended periods (i.e., at least 2½ hours) using a single portable battery or battery pack as the sole power source;

[0061] B. Programmable for use in various different ventilatory modes, such as the above-described IMV, SMV, CMV, PAV, A/C and VPAS.

[0062] C. Usable to ventilate non-intubated mask patients as well as intubated patients.

[0063] D. Oxygen blending capability for delivering oxygen-enriched inspiratory flow.

[0064] E. Capable of providing controlled exhalation back pressure for CPAP or PEEP.

[0065] F. Portable, e.g., less than 30 lbs.

SUMMARY OF THE INVENTION

[0066] The present invention specifically addresses the above referenced deficiencies and needs of the prior art by providing comprises a mechanical ventilator device which incorporates a rotary compressor for delivering intermittent inspiratory gas flow by repeatedly accelerating and decelerating the compression rotor at the beginning and end of each inspiratory-phase. Prior to commencement of each inspiratory ventilation phase, the rotary compressor is stopped, or rotated at a basal rotational speed. Upon commencement of an inspiratory phase, the rotary compressor is accelerated to a greater velocity for delivering the desired inspiratory gas flow. At the end of each inspiratory phase, the rotational velocity of the compressor is decelerated to the basal velocity, or is stopped until commencement of the next inspiratory ventilation phase. A programmable controller is preferably incorporated to control the timing and rotational velocity of the compressor. Additionally, the controller may be programmed to cause the compressor to operate in various modes of ventilation, and various breath types, as employed in modern clinical practice.

[0067] Further in accordance with the present invention, there is provided an oxygen blending apparatus which may be utilized optionally with the rotatable compressor ventilation device of the present invention. The oxygen blending apparatus of the present invention comprises a series of valves having flow restricting orifices of varying size. The valves are individually opened and closed to provide a desired oxygen enrichment of the inspiratory gas flow. The oxygen blending apparatus of the present invention may be controlled by a programmable controller associated with, or separate from, the ventilator controller.

[0068] Still further in accordance with the invention, there is provided an exhalation valve apparatus comprising a housing which defines an expiratory flow path therethrough and a valving system for controlling the airway pressure during the expiratory phase of the ventilation cycle. A pressure transducer monitors airway pressure during exhalation the output of which is used by the controller to adjust the valving system to maintain desired airway pressure.

[0069] In addition the present invention utilizes an exhalation flow transducer to accurately measure patient exhalation flow which may be utilized for determination of exhaled volume and desired triggering of inspiratory flow. In the preferred embodiment, the exhalation flow transducer is integrally formed with the exhalation valve, however, those skilled in the art will recognize that the same can be a separate component insertable into the system. To insure transducer performance accuracy, in the preferred embodiment, the particular operational characteristics of each flow transducer are stored within a memory device preferably a radio-frequency transponder mounted within the exhalation valve to transmit the specific calibration information for the exhalation flow transducer to the controller. Further, the particular construction and mounting of the flow transducer within the exhalation valve is specifically designed to minimize fabrication inaccuracies.

[0070] Further objects and advantages of the invention will become apparent to those skilled in the art upon reading and understanding of the following detailed description of preferred embodiments, and upon consideration of the accompanying drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

[0071] FIG. 1 is a basic schematic diagram of a preferred ventilator system of the present invention incorporating, a) a rotary compressor ventilator device, b) an optional air-oxygen blending apparatus; and c) a controllable exhalation valve, and d) a programmable controller or central processing unit (CPU) which is operative to control and coordinate the functioning of the ventilator, oxygen blending apparatus and exhalation valve.

[0072] FIG. 2 is a detailed schematic diagram of a ventilator system of the present invention.

[0073] FIG. 3 is a front view of the control panel of a preferred ventilator system of the present invention.

[0074] FIG. 4 is a perspective view of a preferred drag compressor apparatus which may be incorporated into the ventilator system of the present invention.

[0075] FIG. 5 is a longitudinal sectional view through line 5 - 5 of FIG. 4 .

[0076] FIG. 6 is an enlarged view of a segment of FIG. 5 .

[0077] FIG. 7 is an enlarged view of a segment of FIG. 6 .

[0078] FIG. 8 is an elevational view of a preferred drag compressor component of a mechanical ventilator device of the present invention.

[0079] FIG. 9 is a perspective view of the drag compressor component of FIG. 8 .

[0080] FIG. 10 is an enlarged view of a segment of FIG. 9 .

[0081] FIG. 11 a is a longitudinal sectional view of a preferred exhalation valve of the present invention.

[0082] FIG. 11 b is a perspective view of the preferred spider bobbin component of the exhalation valve shown in FIG. 11 a.

[0083] FIG. 11 c is an exploded perspective view of a portion of the exhalation valve of FIG. 11 a.

[0084] FIG. 11 d is a perspective view of a portion of the exhalation valve shown in FIG. 11 c.

[0085] FIG. 11 e is an exploded perspective view of the preferred flow restricting flapper component of the exhalation valve shown in FIGS. 11 a - 11 d.

[0086] FIG. 12 is a graphic example of flow vs. speed vs. pressure data generated for a preferred exhalation valve of the present invention, accompanied by an exhalation valve characterization algorithm computed therefrom.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT

[0087] The following detailed description and the accompanying drawings are provided for purposes of describing and illustrating a presently preferred embodiment of the invention and are not intended to describe all embodiments in which the invention may be reduced to practice. Accordingly, the following detailed description and the accompanying drawings are not to be construed as limitations on the scope of the appended claims.

A. General Description of the Preferred Ventilator System

[0088] With reference to FIGS. 1 - 2 , the mechanical ventilation system 10 of the present invention generally comprises a) a programmable microprocessor controller 12 , b) a ventilator device 14 , c) an optional oxygen blending apparatus 16 and d) an exhalation valve apparatus 18 . Which is preferably implemented as a portable, battery powered system.

[0089] The ventilator device 14 incorporates a rotating drag compressor 30 which is driven by an electric motor 102 . In response to control signals received from controller 12 , a bladed rotor within the compressor 30 will undergo rotation for specifically controlled periods of time and/or, within specifically controlled parameters, so as to provide inspiratory gas flow through line 22 to the patient PT.

[0090] The controller 12 comprises a programmable microprocessor which is electrically interfaced a) to the ventilator device 14 by way of control line 13 , b) to the optional oxygen blending apparatus 16 by way of control line 17 , and c) to the exhalation valve 18 by way of control line 19 and also by RF communication between flow transducer transponder ( 21 ) and transmitter/receiver ( 23 ). Preferably incorporated into the exhalation valve 18 as will be described in more detail infra.

[0091] The controller 12 is preferably programmed to utilize selected parameters (e.g., time, flow rate, tidal volume (V t ), airway pressure, spontaneous breath initiation, etc.) for triggering, limiting and cycling the inspiratory flow in accordance with the selected ventilatory mode or breath type.

[0092] At the end of each inspiratory flow cycle, the patient PT is permitted to exhale through exhalation valve 18 . The flow rate or pressure of the expiratory flow through exhalation valve 18 is controlled by varying the degree of flow restriction within the exhalation valve 18 , in response to control signals received through line 19 from controller 12 . This enables the exhalation valve 18 to be utilized to create a selected expiratory back pressure (e.g., CPAP, PEEP).

[0093] Optional oxygen blending apparatus 16 may be utilized to enrich the oxygen content of the inspiratory gas flow provided by the drag compressor ventilator device 14 . The preferred oxygen blending apparatus 16 comprises a plurality of (preferably five (5)) solenoid valves 52 , each having a specific sized flow restricting orifice. The solenoid valves 52 are arranged in parallel between an oxygen inflow manifold 26 and an oxygen outflow manifold 28 . The controller 12 is programmed to open and close the individual solenoid valves 52 for specific periods of time so as to provide a metered flow of oxygen through oxygen outflow manifold 28 and into accumulator 54 . Ambient air is drawn through conduit 24 and filter 50 , into accumulator 54 , where the ambient air combines with the metered inflow of oxygen to provide an oxygen-enriched inspiratory flow containing a prescribed oxygen concentration (FIO 2 ).

[0094] The presently preferred embodiment of the system 10 will operate when supplied with voltage input within the range of 85-264 VAC at 50/60 Hz.

[0095] An AC power cord is preferably connectable to the system 10 to provide AC power input.

[0096] Additionally, the system 10 preferably includes an internal battery capable of providing at least 15 minutes, and preferably 30 minutes, of operation. During internal battery operation, some non-essential displays may be dimmed or disabled by the controller 12 . The internal battery is preferably capable of being recharged by AC power input provided through the AC power cable, or by a separate battery charger. The internal battery is preferably capable of being fully charged, from a no charged state, within 24 hours. The internal battery charge light 306 shown on the panel of the preferred controller 12 a may additionally flash if desired during charging of the internal battery.

[0097] Also, the system may include an external battery or battery set capable of providing at least 2 hours of operation, and preferably capable of providing 4 to 8 hours of operation. During external battery use, some non-essential displays may be dimmed or disabled by the controller 12 . The battery or battery set is preferably capable of being recharged by delivery of AC power through the AC power cable, or by a separate battery charger. It is preferable that the external battery or battery set be capable of being fully charged, from a no charged state within 24 to 48 hours. The external battery charge light 310 on the panel of the preferred controller 12 a may additionally flash if desired during charging of the external battery or battery set.

B. The Preferred Controller Apparatus

[0098] It will be appreciated that the controller 12 of the ventilator system 10 of the present invention will vary in complexity, depending on the specific capabilities of the system 10 , and whether or not the optional oxygen blending apparatus 16 is incorporated.

[0099] FIG. 3 shows the control panel of a preferred controller apparatus 12 a which is usable in connection with a relatively complex embodiment of the ventilatory system 10 , incorporating the optional oxygen blending apparatus 16 .

[0100] Controls Settings and Displays

[0101] The specific control settings and displays which are included in the preferred controller 12 a , and the ways in which the preferred controller 12 a receives and utilizes operator input of specific control settings, are described herebelow:

[0102] 1. Standby-Off Control

[0103] The ventilator system 10 incorporates a stand by/off switch (not shown) which turns the main power on or off. A group of indicator lights 300 are provided on the face panel of the controller 12 a , and are more fully described herebelow under the heading “monitors”. In general, the panel indicator lights include an “on” indicator 302 which becomes illuminated when the ventilator is turned on. An AC power low/fail indicator light 304 activates when the AC power cord is present and the voltage is out of a specified operating range. Upon sensing low or faulty AC power, the controller 12 a will automatically switch the ventilator 14 to internal battery power. The ventilator will continue to operate on internal battery power until such time as power in the internal battery reaches a minimum level. When the power in the internal battery reaches a minimum level, the controller 12 a will cause the internal battery light and/or audible alarm 308 to signal that the internal battery is near depletion.

[0104] A separate external battery light and/or audible alarm 312 is also provided. The external battery light and/or audible alarm will activate when the external battery is in use, and has a battery voltage which is out of the acceptable operation range. During this condition, the controller 12 a will cause all nonessential displays and indicators to shut down.

[0105] When AC power is connected to the ventilator 14 , but the ventilator is turned off, any internal or external batteries connected to the ventilator will be charged by the incoming AC current. Internal battery charge indicator light 306 and external battery charge indicator light 306 and external battery charged indicator light 310 are provided, and will blink or otherwise indicate charging of the batteries when such condition exists.

[0106] 2. Mode Select

[0107] A mode select module 320 incorporates plural, preferably five (5) mode select buttons 322 , 324 , 326 , 328 , 330 . Mode select button 322 sets the system 10 for Assist Control (a/c). Mode select button 324 sets the system 10 for Synchronized Intermittent Mandatory Ventilation (SIV). Mode select button 326 sets the system for Continuous Positive Airway Pressure (CPAP).

[0108] Spare mode select buttons 328 , 330 are provided to permit the controller 12 a to be programmed for additional specific ventilation modes such as volume assured pressure support (VAPS) or proportional assist ventilation. When the controller is programmed for additional specific ventilation modes, select buttons 328 , 330 may be correspondingly labeled and utilized to set the ventilator 14 to deliver such subsequently programmed ventilation modes.

[0109] 3. Tidal Volume

[0110] A digital tidal volume display 332 , with corresponding tidal volume setting button 332 a are provided. When tidal volume setting button 332 a is depressed, value setting knob 300 may be utilized to dial in a selected tidal volume. The tidal volume display 332 will then provide a digital display of the currently selected tidal volume value.

[0111] The typical range of setable tidal volumes is 25 ml-2000 ml.

[0112] 4. Breath Rate

[0113] A digital breath rate display 334 , with corresponding breath rate setting button 334 a is provided. When breath rate setting button 334 a is depressed, value setting knob 300 may be utilized to dial in the desired breath rate. Breath rate display 334 will thereafter display the currently selected breath rate.

[0114] The typical rage of selectable breath rates is 0 to 80 breaths per minute.

[0115] 5. Peak Flow

[0116] A digital peak flow display 336 , and corresponding peak flow setting button 336 a are provided. When peak flow setting button 336 a is depressed, value setting knob 300 may be utilized to dial in the desired peak flow. The peak flow display 336 will, thereafter, provide a digital display of the currently selected peak flow.

[0117] The typical range of peak flow settings is 10 to 140 liters per minute.

[0118] 6. Flow Sensitivity

[0119] A flow sensitivity digital display 338 , and corresponding flow sensitivity setting button 338 a are provided. When flow sensitivity setting button 338 a is depressed, value setting knob 300 may be utilized to dial in the desired flow sensitivity setting. The flow sensitivity setting display 338 will, thereafter, provide a digital display of the currently selected flow sensitivity setting.

[0120] The flow sensitivity setting determines the trigger level for initiation of volume and pressure-controlled assist breaths or pressure support breaths. The initiation of volitional inspiratory effort by the patient creates a change in airway flow as determined by: (turbine bias flow)−(exhalation flow)=patient flow. Triggering occurs when the patient airway flow exceeds the sensitivity setting. The typical range of selectable flow sensitivity settings is from one to ten liters per minute, or off.

[0121] Optionally, a fail safe feature may be incorporated whereby, if the patients flow demand does not exceed the flow sensitivity setting, but the airway pressure drops more than 5 cmH 2 O below the set PEEP level, and inspiratory cycle will be initiated and a breath will be delivered based on current mode and control settings.

[0122] 7. PEEP/CPAP

[0123] A PEEP/CPAP digital display 340 , with corresponding PEEP/CPAP setting button 340 a are provided. When PEEP/CPAP setting button 340 a is depressed, the value setting knob 300 may be utilized to dial in the desired PEEP/CPAP setting.

[0124] The current PEEP/CPAP setting sets the level of pressure in the patient circuit that is maintained between the end of inspiration and the start of the next inspiration. It is also known as the “baseline” pressure.

[0125] The preferred range of PEEP/CPAP setting is 0 to 50 cmH 2 O.

[0126] 8. Pressure Support

[0127] A pressure support digital display 342 , and corresponding pressure support setting button 342 a , are provided. When pressure support setting button 142 a is depressed, value setting knob 300 may be utilized to dial in the desired pressure support setting.

[0128] The pressure support setting determines the inspiratory patient circuit pressure during a pressure support breath. This control sets the pressure support level above the baseline setting established by the PEEP/CPAP setting. The total delivered pressure equals the PEEP or CPAP value+pressure support.

[0129] The typical range of pressure support settings is from 1 to 60 centimeters of water (cmH 2 O), or off.

[0130] 9. FiO 2 (%O 2 )

[0131] An FiO 2 digital display 348 , and corresponding FiO 2 setting button 348 a , are provided. When the FiO 2 setting button 348 a is depressed, the value setting knob 300 may be utilized to dial in the desired fractional percentage of oxygen in the air/oxygen gas mixture that is delivered to the patient PT and used for the bias flow. In response to the FiO 2 setting, the controller 12 will issue control signals to the oxygen blending apparatus 16 to effect the preset FiO 2 .

[0132] The preferred range of setable FiO 2 is between 0.21 and 1.0 (i.e., 21-100 percent oxygen)

[0133] 10. Pressure Control (Optional)

[0134] A pressure control digital display 350 , and corresponding pressure control setting button 350 a are provided. When the pressure control setting button 350 a is depressed, the value setting knob 300 may be utilized to dial in the desired pressure control value.

[0135] The pressure control setting enables the system 10 to be utilized for pressure control ventilation, and determines the inspiratory pressure level during delivery of each pressure control breath. The pressure control setting sets the pressure level above any PEEP.

[0136] It is preferable that the range of possible pressure control settings be from 1 to 100 cmH 2 O.

[0137] 11. Inspiratory Time (Optional)

[0138] An optional inspiratory time digital display 352 , and corresponding inspiratory time setting button 352 a may be provided. When the inspiratory time setting button 352 a is depressed, the value setting of 300 may be utilized to dial in the desired inspiratory time.

[0139] The set inspiratory time is the time period for the inspiratory phase of a pressure control breath. Thus, this inspiratory time setting is normally usable for pressure control ventilation.

[0140] It is preferable that the range of setable inspiratory times being from 0.3 to 10.0 seconds.

[0141] 12. Additional Displays/Settings

[0142] Additional digital displays 344 , 346 , 354 , 356 and corresponding setting buttons 344 a , 346 a , 354 a , 356 a are provided to permit the controller 12 to be subsequently programmed or expanded to receive and display additional control settings beyond those which have been described hereabove.

[0143] 13. Sigh On/Off

[0144] A sigh on/off button 360 is provided. When sigh on/off button 360 is depressed, the controller 12 will cause the ventilator 14 to deliver a sigh breath. A sigh breath is a volume-controlled, mandatory breath that is usually equal to 1.5 times the current tidal volume setting shown on tidal volume setting display 332 . The sigh breath is delivered according to the current peak flow setting shown on peak flow setting display 336 . The inspiratory phase of the sigh breath is preferably limited to a maximum of 5.5 seconds. During a sigh breath, the breath period is automatically increased by a factor of 1.5. The sigh breath function is available during all ventilation modes.

[0145] A single depression of the sigh on/off button 348 will cause the ventilator to deliver a volume-controlled sigh breath once every 100 breaths or every 7 minutes, which ever comes first. The sigh breath button 360 includes a visual indicator light 360 a which illuminates when the sigh on/off button 360 is depressed and the sigh/breath function is active.

[0146] 14. Manual Breath

[0147] A manual breath button 362 is also provided. Upon depression of the manual breath button 362 , the controller 12 will cause the ventilator 14 to deliver a single volume-controlled or pressure control breath in accordance with the associated volume and/or pressure control settings. An indicator light 362 a will illuminate briefly when manual breath button 362 is depressed.

[0148] 15. Remote Alarm (Optional)

[0149] A remote alarm on/off control button 364 is provided to enable or disable the remote alarm. When the remote alarm on/off control button 364 is depressed, indicator light 364 a will illuminate. When the remote alarm on/off button 364 is depressed, the remote alarm will be enabled. When this function is enabled, alarm conditions will transmit via hard wire or radio frequency (wireless) to a remote alarm which may be mounted on the outside of a patients room so as to signal attendants outside of the room, when an alarm condition exists.

[0150] The specific alarm conditions which may be utilized with the remote alarm function, are described in greater detail herebelow.

[0151] 16. Flow Waveform (Optional-Applies to Volume Breaths Only)

[0152] The controller 12 includes a square flow wave form activation button 366 and a decelerating taper flow wave form actuation button 368 . When the square flow wave form actuation button 366 is depressed, indicator light 366 a will illuminate, and the ventilator will deliver inspiratory flow at a constant rate according to the peak flow setting, as input and shown on peak flow display 336 . When the decelerating paper wave form actuation button 368 is depressed, indicator light 368 a will illuminate, and the ventilator will deliver an inspiratory flow which initially increases to the peak flow setting, as input and shown on peak flow display 336 , then such inspiratory flow will decelerate to 50 percent of the peak flow setting at the end of the inspiratory phase.

[0153] 17. Inspiratory Hold (Optional)

[0154] An inspiratory hold actuation button 370 is provided, to enable the operator to hold the patient at an elevated pressure following inspiration, so that breath mechanics can be calculated. The length of the delay period is determined by the period of time during which the inspiratory hold button 370 remains depressed, with a maximum limit applied.

[0155] 18. Expiratory Hold (Optional)

[0156] The controller 12 also includes an expiratory hold actuation button 372 , which enables the ventilator to calculate auto PEEP. During the expiratory hold, the turbine 30 operation is halted and the exhalation valve 18 remains closed. The difference between the end expiratory pressure, as measured at the end of the expiratory hold period, minus the airway pressure reading recorded at the beginning of the expiratory hold period, will be displayed on monitor window 384 .

[0157] 19. Maximal Inspiratory Pressure/Negative Inspiration Force (Optional)

[0158] The preferred controller 12 also incorporates a maximal inspiratory pressure test button 374 , to enable the operator to initiate a maximal inspiratory pressure (MIP) test maneuver. This maneuver causes the ventilator to stop all flow to or from the patient. The patient inspiratory effort is then monitored and displayed as MIP/NIF in the monitor window 384 .

[0159] 20. 100% O 2 Suction (Optional)

[0160] Optionally, the controller 12 a includes a 100% O 2 actuation button 376 which, when depressed, will cause indicator light 376 a to illuminate and will cause the system 10 to deliver an FiO 2 of 1.00 (i.e., 100% oxygen) to the patient for a period of three (3) minutes regardless of the current FiO 2 setting and/or breath type setting.

[0161] This 100% O 2 feature enables the operator to selectively deliver 100% oxygen to the patient PT for a three minute period to hyperoxygenate the patient PT prior to disconnection of the patient from the ventilator circuit for purposes of suctioning, or for other clinical reasons.

[0162] 21. Additional Control Actuation Buttons

[0163] An additional control actuation button 378 , with indicator light 378 a , is provided to enable the controller 12 a to be subsequently programmed to perform additional control actuation functions beyond those described hereabove.

[0164] Monitors and Indicators

[0165] 1. AC Power Status Indicator

[0166] An AC power indicator light 304 is provided in the face panel of the controller 12 to indicate when sufficient AC power is available and the standby/off switch (not shown) is in the standby position.

[0167] 2. Internal Battery Status Indicator(s)

[0168] An internal battery status indicator light 308 is provided on the panel of the controller 12 , and will indicate battery charge level according to predetermined color signals. A separate internal battery charge indicator light 306 may be provided, and will indicate charging status according to predetermined color signals.

[0169] 3. External Battery Status Indicator(s)

[0170] An external battery status indicator light 312 is provided on the panel of the controller 12 , and will indicate battery charge level according to predetermined color signals. A separate external battery charge indicator light 310 may be provided, and will indicate charging status according to predetermined color signals.

[0171] 4. Airway Pressure Monitor

[0172] The display panel of the controller 12 includes a real time airway pressure bar graph display 380 . A green indicator bar will appear on the airway pressure bar graph display 380 to indicate the real time airway pressure at all times. Red indicators will appear on the airway pressure bar graph to indicate high and low peak pressure alarm setting, as more fully described herebelow under the heading “Alarms”. An amber colored indicator will appear on the airway pressure bar graph display 380 to indicate the current PEEP/CPAP setting, Pressure Support setting and/or Pressure Control setting. A patient effort indicator light 382 is located near the airway pressure bar graph display 380 , and will illuminate to indicate the occurrence of a patient-initiated breath, including all spontaneous, assist or pressure support breaths.

[0173] 5. Digital Monitor Display

[0174] The panel of the controller 12 preferably includes a digital monitor display 384 and an accompanying monitor select button 386 . The controller 12 is programmed to display various monitored parameters. Each time the monitor select button 386 is depressed, the monitored parameters displayed on monitor display 384 will change. The individual parameters may include: exhaled tidal volume, i.e., ratio, mean airway pressure, PEEP, peak inspiratory pressure, total breath rate, total minute ventilation.

[0175] Additionally, a display power saving feature may be incorporated, whereby the controller 12 will automatically cause the monitor display 384 to become non-illuminated after a predetermined display period when the system 10 is operating solely on internal or external battery power. Each time the monitor select button 386 is depressed, the display 384 will illuminate for a predetermined period of time only, and then will become non-illuminated. This feature will-enable the system 10 to conserve power when the system 10 is being operated solely on internal or external battery power.

[0176] Additionally, the controller 12 may be programmed to cause the monitor display 384 to display a special or different group of parameters during a specific operator-initiated maneuver. Examples of special parameter groups which may be displayed during a specific maneuver include the following:

[0177] Real-time Pressure (at start of and during all maneuvers)

[0178] Plateau Pressure (Inspiratory Hold)

[0179] Compliance (Inspiratory Hold)

[0180] End Expiratory Pressure (Expiratory Hold)

[0181] Auto PEEP (Expiratory Hold)

[0182] Maximal Inspiratory Pressure (MIP/NIF)

[0183] Alarms and Limits

[0184] The preferred controller 12 may be programmed to received operator input of one or more limiting parameters, and to provide audible and/or visual alarm indications when such limiting parameters have been, or are about to be, exceeded.

[0185] The visual alarm indicators may comprise steady and or flashing lights which appear on the control panel of the preferred controller 12 a.

[0186] The audible alarm components will preferably comprise electronic buzzers or beepers which will emit sound discernable by the human ear for a preselected period (e.g., 3 seconds). Preferably, the audible portion of any alarm may be volitionally muted or deactuated by the operator.

[0187] Additionally it is preferable that the controller 12 be programmed to automatically reset each alarm if the current ventilation conditions do not fall outside of the preset alarm limits.

[0188] Examples of specific limiting parameters and alarm limits which may be programmed into the preferred controller 12 , are as follows:

[0189] 1. High Peak Pressure

[0190] The preferred controller 12 includes, on its face panel, a high pressure digital display 390 and a corresponding high pressure alarm limit setting button 390 a . When the high pressure alarm limit setting button 390 a is depressed, value setting knob 300 may be utilized to dial in a desired high pressure alarm limit value. Such high pressure alarm limit value will then be displayed on high pressure alarm limit display 390 .

[0191] The currently set high pressure alarm limit, as shown on high pressure alarm limit display 390 , will establish the maximum peak inspiratory pressure for all breath types. When the monitored airway pressure exceeds the currently set high pressure alarm limit, audible and visual alarms will be actuated by the controller 12 and the controller will immediately cause the system 10 to cycle to expiratory mode, thereby allowing the airway pressure to return to the baseline bias flow level and along the exhalation valve 18 to regulate pressure at any currently-set peep level.

[0192] In order to avoid triggering of the high pressure alarm during delivery of a sigh breath, the controller 12 will be programmed to automatically adjust the high pressure alarm limit value by a factor of 1.5× during the deliver of a sigh breath, provided that such does not result in the high pressure limit value exceeding 140 cmH 2 O. The controller 12 is preferably programmed not to exceed a high pressure limit setting of 140 cmH 2 O, even during delivery of a sigh breath.

[0193] 2. Low Peak Pressure

[0194] A low peak airway pressure limit display 392 , and corresponding low peak pressure limit setting button 392 a , are also provided. When the low peak pressure limit setting button 392 a is depressed, value setting knob 300 may be utilized to dial in a desired low peak airway pressure alarm limit value. Such low peak pressure alarm limit value will then be displayed in the low peak pressure display 392 .

[0195] Audible and/or visual alarms will be activated if the monitored airway pressure fails to exceed the low peak pressure alarm limit setting during the inspiratory phase of a machine-cycled mandatory or assist breath.

[0196] The controller 12 is preferably preprogrammed to

[0197] 5. Spare Alarm Limit Displays and Setting Buttons

[0198] Spare alarm limit displays 396 , 398 , and corresponding spare alarm limit setting buttons 396 a and 398 a are provided, to permit the controller 12 to be subsequently expanded or programmed to receive operator input of additional limiting parameters, and to provide auditory and/or visual alarms when such limiting parameters have been exceeded.

[0199] 6. Ventilator Inoperative

[0200] A separate ventilator inoperative light indicator 400 is provided on the face panel of the controller 12 . The controller 12 is programmed to cause the ventilator inoperative light to illuminate when predetermined “ventilatory inoperative” conditions exist.

[0201] 7. AC Power Low/Fail

[0202] The controller 12 is preferably programmed to activate visual and/or auditory alarms when an AC power cord is connected to the system 10 and the voltage received by the system 10 is outside of a specified operating range. The controller 12 is preferably also programmed to automatically switch the system 10 to internal battery power under this condition. The AC power low/fail alarm can be silenced, and will remain silenced, until such time as the internal low battery alarm 208 becomes actuated, indicating that the internal battery has become depleted.

[0203] 8. External/Internal Battery Low/Fail

[0204] The controller 12 may be programmed to actuate a visual and or auditory alarm when an external or internal battery is in use, and the battery voltage is outside of an acceptable operating range.

[0205] 9. O 2 Inlet Pressure

[0206] The controller 12 may be programmed to provide auditory and/or visual alarms when the oxygen pressure delivered to the system 10 is above or below predetermined limits.

[0207] 10. Over Pressure Relief Limit

[0208] The system 10 includes a mechanical variable pressure relief valve 64 , to relieve any over pressurization of the patient circuit.

[0209] The range of setable over pressure relief limit values may be between 0 to 140 cmH 2 O.

[0210] Self Testing and Auto Calibration Functions

[0211] 1. Self Test Function

[0212] The preferred controller 12 may be programmed to perform a self-testing function each time the ventilator is powered up. Such self testing function will preferably verify proper functioning of internal components such as microprocessors, memory, transducers and pneumatic control circuits. Such self testing function will also preferably verify that electronic sub-systems are functioning correctly, and are capable of detecting error conditions re