Portable drag compressor powered mechanical ventilator

• US 5,881,722 A
• Filed: 09/25/1995
• Issued: 03/16/1999
• Est. Priority Date: 10/14/1994
• Status: Expired due to Term

• Current Assignee: Bird Products Corporation (Becton, Dickinson & Co)
• Original Assignee: Bird Products Corporation (Becton, Dickinson & Co)
• Inventors: DeVries, Douglas F., Graves, Warner V. Jr., Williams, Malcolm R., Cegielski, Michael J., Holmes, Michael B.
• Primary Examiner(s): Asher, Kimberly L.
• Application Number:
  US08/533,665
• Time in Patent Office: 1,268 Days
• Field of Search: 128/204.18, 128/204.21, 128/204.23, 128/204.26, 128/205.11, 128/205.24, 128/716-719, 417/1, 417/18, 417/20, 417/22-24, 417/423.1, 417/455, 73/861, 73/861.02, 73/861.42, 73/861.45, 73/861.47, 73/488, 73/494
• US Class Current: 128/204.21
• CPC Class Codes: A61M 16/0051 with alarm devices
• CPC Class Codes: A61M 16/0057 Pumps therefor
• CPC Class Codes: A61M 16/0063 Compressors
• CPC Class Codes: A61M 16/0069 the speed thereof being controlled by respiratory parameters, e.g. by inhalation
• CPC Class Codes: A61M 16/024 including calculation means, e.g. using a processor
• CPC Class Codes: A61M 16/0833 T- or Y-type connectors, e.g. Y-piece
• CPC Class Codes: A61M 16/1015 using a gas flush valve, e.g. oxygen flush valve
• CPC Class Codes: A61M 16/107 in the inspiratory path
• CPC Class Codes: A61M 16/12 by mixing different gases
• CPC Class Codes: A61M 16/125 Diluting primary gas with ambient air
• CPC Class Codes: A61M 16/20 Valves specially adapted to medical respiratory devices
• CPC Class Codes: A61M 16/202 electrically actuated
• CPC Class Codes: A61M 16/205 used for exhalation control
• CPC Class Codes: A61M 16/206 Capsule valves, e.g. mushroom, membrane valves
• CPC Class Codes: A61M 16/208 Non-controlled one-way valves, e.g. exhalation, check, pop-off non-rebreathing valves
• CPC Class Codes: A61M 16/209 Relief valves
• CPC Class Codes: A61M 2016/0021 with a proportional output signal, e.g. from a thermistor
• CPC Class Codes: A61M 2016/0027 pressure meter
• CPC Class Codes: A61M 2016/0036 in the breathing tube and used in both inspiratory and expiratory phase
• CPC Class Codes: A61M 2016/0039 in the inspiratory circuit
• CPC Class Codes: A61M 2016/0042 : in the expiratory circuit
• CPC Class Codes: A61M 2202/0208 : Oxygen
• CPC Class Codes: A61M 2205/16 : with back-up system in case of failure
• CPC Class Codes: A61M 2205/18 : with alarm
• CPC Class Codes: A61M 2205/3331 : Pressure; Flow
• CPC Class Codes: A61M 2205/3365 : Rotational speed
• CPC Class Codes: A61M 2205/3561 : local, e.g. within room or hospital
• CPC Class Codes: A61M 2205/3569 : sublocal, e.g. between console and disposable
• CPC Class Codes: A61M 2205/3592 : using telemetric means, e.g. radio or optical transmission
• CPC Class Codes: A61M 2205/42 : Reducing noise
• CPC Class Codes: A61M 2205/502 : User interfaces, e.g. screens or keyboards
• CPC Class Codes: A61M 2205/581 : by audible feedback
• CPC Class Codes: A61M 2205/587 : Lighting arrangements
• CPC Class Codes: A61M 2205/70 : with testing or calibration facilities
• CPC Class Codes: A61M 2205/8206 : battery-operated
• CPC Class Codes: A61M 2205/8212 : with means or measures taken for minimising energy consumption
• CPC Class Codes: A61M 2230/46 : Resistance or compliance of the lungs
• CPC Class Codes: G01F 1/40 : Details of construction of the flow constriction devices
• CPC Class Codes: G01F 1/42 : Orifices or nozzles

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.

Claims

1. 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;

an annular valve seat formed within said expiratory gas flow passageway;

an annular diaphragm movably disposed within said gas flow passageway, in juxtaposition to said annular 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 annular 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 contactable 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 containing flow characterization data specific for said exhalation valve 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, and to utilize such data to determine the instant flow rate of expiratory gas passing out of said exhalation valve.

2. The exhalation valve of claim 1 wherein said controller is located remote from, said exhalation valve.

3. The exhalation valve of claim 1 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.

4. 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 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 end 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 spirally wound contiguous convolutions of wire upon which a rigidifying coating has been applied to hold said wire in a closely coiled substantially cylindrical configuration without an internal support structure;

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.

5. The exhalation valve of claim 4 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 valve seat and will subsequently move into contact with the remainder of said valve seat.

6. 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 be abut against said valve seat to thereby block the flow of gas through said exhalation passageway, said diaphragm being moveable back and forth between a first position wherein said diaphragm is fully retracted from said valve seat to permit unrestricted flow through said passageway;

a second position wherein said diaphragm is seated on said valve seat to block flow through said passageway; and

a range of intermediate positions between said first and second positions wherein said diaphragm will cause varying degrees of restriction of 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 a first position wherein the first end of said shaft is at a location which will retain said diaphragm in its first position;

a second position wherein the first end of said shaft is at a location which will allow said diaphragm to move to its second position; and

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;

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.

7. The exhalation valve of claim 6 wherein said dust barrier comprises an elastomeric boot.

8. The exhalation valve of claim 6 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.

9. An exhalation valve comprising:

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;

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;

a flow measuring apparatus for monitoring the flow rate of expiratory gas passing through said exhalation valve; and

specific flow-pressure calibration information for the flow measuring apparatus stored on a storage medium contained within the exhalation valve housing.

10. The exhalation valve of claim 9 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;

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.

11. The exhalation valve device of claim 10 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 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.

12. The exhalation valve device of claim 11 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.

13. The exhalation valve device of claim 11 further comprising:

a cushioning washer and a third frame member disposed on at least one of the first and second frame member which abut against the same so as to evenly distribute stresses applied to said sheet by said frame members.

14. The exhalation valve device of claim 13 wherein said cushioning washer comprises an elastomeric material disposed on said third frame member.

15. The exhalation valve device of claim 9 wherein said storage medium comprises a radio-frequency transponder.

16. The exhalation valve device of claim 9 wherein the characterization information stored on said storage medium comprises a data base of predetermined pressure differences for specific flow rates of said exhalation valve.

17. The exhalation valve device of claim 9 wherein the information stored on said storage medium comprises an equation for calculating specific flow rates base on measured pressure differentials for that exhalation valve.