Portable Ventilator Apparatus

The present invention relates to ventilator apparatus, and particularly to portable ventilator apparatus useful for providing mechanical ventilation of a patient at home or during transport.

Ventilating apparatus is widely used for mechanically forcing air into the lungs of a patient requiring ventilatory assistance. Some ventilators are designed for continuous use in hospitals, such as in intensive care units; and others are designed as portable units for use in the home or during transport. Examples of the latter are described in U.S. Pat. Nos. 3,499,601, 4,215,681 and 4,493,614. The present invention is particularly applicable to ventilators of the portable type for use in the home or during transport.

Ventilators are usually also divided into the following types:

1. Pressure ventilators, usually including a source of compressed air administered by a solenoid valve at a rate of 10-30 breaths per minute. Such ventilators usually include large-size pistons (e.g., 10-12 inch diameters) having sealing surfaces with respect to the cylinders in which they move, and in general are characterized by bulky construction precluding portability, high power consumption because of continuous operation precluding the use of batteries, and/or poor control of the volume the patient inhales with each breath.

2. Volume ventilators, usually including a large reciprocating piston driven by an electric motor for compressing air into the patient's lungs at a preset fixed volume with the cycling frequency varying from 5 to 40 breaths per minute. Such ventilators are generally characterized by inability to attain high frequencies required for baby respiration, poor control of the volumes when they are set very low since the piston stroke becomes very critical, and/or poor mechanical efficiency since most of the energy is expended in overcoming friction in the piston seal and in the transmission from the motor to the piston.

3. Continuous positive airway pressure (CPAP) ventilators, usually including a compressor providing continuous positive pressure at a low pressure level. Such ventilators are usually used only for applying a positive pressure to the patient's lungs in order to help alleviate obstructive apnea during sleep while the patient breathes against the continuous pressure.

4. High-frequency positive-pressure ventilators, in which a source of compressed air is controlled to deliver air to the patient at controlled volumes and at rates between 60 and 120 breaths per minute. Such ventilators are usually of bulky construction and therefore are primarily used in clinical applications.

5. High-frequency jet ventilators, which include compressors delivering high pressure air directly to the lungs at frequencies of up to 400 cycles per minute.

6. High-frequency oscillation ventilators, which include compressors delivering very small volumes of pressurized air to the lungs at frequencies of up to 2400 cycles per minute.

My prior application Ser. No. 07/071,327 discloses ventilator apparatus which may be embodied in a compact, portable construction and which can substantially duplicate the performance of all six types of ventilators described above.

The present application is directed particularly to ventilators of the CPAP (continuous positive airway pressure) type (Type 3 above) for helping to alleviate obstructive apnea during sleep.

The presently used CPAP ventilators generally include small turbines, such as vacuum cleaner turbines, generating high air flow rates with low pressure. They also include a relief valve, commonly called a "PEEP" (Positive End Expiratory Pressure) valve which releases the pressure to the atmosphere when the pressure in the delivery conduit rises above a predetermined value. However, such known CPAP ventilators are usually characterized by the following shortcomings: (1) they are noisy; (2) they are wasteful of power, since they generate an air flow which is not only far in access of the patient's needs to guarantee sufficient flow for all patients under various conditions, but they also generate air flow while the patient is exhaling; (3) they are wasteful of oxygen when applied to the delivered air, since the oxygen is included with the continuously supplied air; and (4) for the same reasons, they are also wasteful of moisture when a humidifier is used to humidify the delivered air.

An object of the invention in the present application is to provide a ventilator apparatus of the type described in Application Ser. No. 07/071,327, designed particularly to be used as a CPAP ventilator but not subject to the above drawbacks of the existing ventilators of this type.

According to the invention of the present application, there is provided ventilator apparatus comprising a pump including a negative-pressure air inlet and a positive-pressure air outlet, delivery means connected to the positive-pressure air outlet for delivering pressurized air to a patient, and a relief valve communicating with the delivery means for preventing the pressure in the delivery means from rising above a predetermined peak value; characterized in that the apparatus further includes a sensor located in the delivery means between the positive-pressure outlet of the pump and the patient for sensing the positive pressure in the delivery means, and control means effective to energize the pump when the sensed pressure in the delivery means is below said peak value, and to deenergize the pump whenever the sensed pressure is substantially equal to the peak value.

In the described preferred embodiment, the control means comprises a storage device for storing the peak pressure sensed by the sensor, and a comparator for continuously comparing the sensed (current) pressure with the stored peak pressure and effective to energize the pump whenever the sensed pressure in the delivery means is below the stored peak value, and to deenergize the pump whenever the sensed pressure is substantially equal to the stored peak value.

More particularly, the pressure sensor produces an electrical output corresponding to the pressure sensed by the sensor. The storage means is an electrical device storing the peak pressure sensed by the sensor, and the comparator is an electrical comparator circuit for continuously comparing the sensed pressure with the peak pressure stored in the storage device.

It will thus be seen that the novel ventilator apparatus of the present application is particularly useful as a CPAP ventilator for alleviating obstructive apnea during sleep. In this application, the relief (i.e., the PEEP) valve would be set at a predetermined peak pressure, and the sensor and its control systems (i.e., the storage device and the comparator circuit in the described preferred embodiment) would be effective to intermittently operate the pump so as to avoid wasting power, as well as oxygen and moisture when oxygen and moisture are supplied with the pressurized air to the patient. This makes the CPAP ventilator very efficient and quiet, and enables it to save oxygen and moisture, as well as electrical power. Also, the electrical sensing circuit senses the PEEP pressure upon each exhalation cycle, and memorizes it so that it controls the pump according to that pressure, thereby eliminating the need for any adjustment on behalf of the user.

The invention is herein described, by way of example only, with reference to the accompanying drawings, wherein:

FIG. 1 is a longitudinal sectional view illustrating one form of ventilator apparatus constructed in accordance with the present invention:

FIG. 2 is a fragmentary view illustrating a variation that may be used in the drive;

FIG. 3 is a fragmentary view illustrating a variation that may be used in the construction of the flow passageways in the ventilator apparatus of FIG. 1; and

FIG. 4 schematically illustrates a CPAP (continuous positive airway pressure) ventilator constructed in accordance with the present invention.

The ventilator apparatus illustrated in FIG. 1 is designed to provide maximum portability. For this purpose, it is constituted of three separate units, namely a pump unit 2, a humidifier unit 4, and a fluid collector unit 6, which may be conveniently detached from each other for transportation or storage, and quickly attached to each other when the apparatus is to be used for providing mechanical ventilation.

Generally speaking, pump unit 2 includes the drive for producing the positive air pressure providing the mechanical ventilation; humidifier unit 4 is connectable to the positive-pressure outlet of the pump unit for humidifying the air outputted by that unit; and fluid collector unit 6 is connectable to the negative-pressure inlet of the pump unit, whenever desired, in order to draw fluid accumulating in the lungs of the patient. Each of these units will be described more particularly below.

Pump unit 2 includes a housing 10 provided with a handle 12 for portability, an electric motor 14 for driving the pump, and a compartment 16 for a self-contained power supply. Motor 14 drives a pair of pistons 18, 20 disposed within a cylinder 22 and connected together by a piston rod 24. Motor 14 is a rotary motor and its output rotary shaft 26 is coupled to piston rod 24 via an eccentric bearing 28, a crank arm 30, and another eccentric bearing 32, so that the rotary output of the motor is converted to a reciprocatory movement of the two pistons 18, 20 within the cylinder 22. The rotary shaft 26 of the motor further includes a flywheel 34.

The end of cylinder 22 adjacent to piston 18 is closed by an end wall 36 fixed to the cylinder by an end fitting 38. Piston 18 is formed with a port 40 closed by an umbrella-type valve 42 disposed on the outer face of the piston to permit air to flow outwardly through port 40 but not in the reverse direction. End wall 36 is similarly formed with a port 44 closed by another umbrella-type valve 46 on the outer face of the end wall to permit air to flow outwardly through port 44 and not in the reverse direction. A similar construction is provided at the opposite end of cylinder 22 adjacent to piston 20, namely an end wall 48 fixed by an end fitting 50, a port 52 through piston 20 closed by an umbrella-type valve 54 on the outer face of the piston, and a port 56 through end wall 48 and closed by an umbrella-type valve 58 on the outer face of the end wall.

It will thus be seen that the space on the inner sides of the two pistons 18, 20 defines a common chamber 60 in which a negative pressure is produced during the reciprocation of the two pistons, and that the spaces on the outer sides of the two pistons define two chambers 62, 64 in which a positive pressure is produced during the reciprocation of the pistons. It will also be seen that the spaces 66 and 68 between the end walls 36 and 48 and their respective end fittings 38 and 50 define two further positive-pressure chambers communicating with the positive-pressure chambers 62 and 64, respectively, through ports 44 and 56 of their respective end walls.

The air drawn into the negative-pressure chamber 60 during the reciprocation of the pistons 18, 20 enters the chamber via an inlet 70 formed in an inlet fitting 72. The latter fitting is removably attached to an annular flange 74 formed in housing 10 around an inlet port 76 communicating with the negative-pressure chamber 60. A filter 78 is interposed between fitting 72 and flange 74 to filter the air inletted into the negative- pressure chamber 60.

The positive-pressure chamber 66 at the piston 18 end of the cylinder 22 includes an outlet fitting 80 adapted to receive a tube 82 for outletting the positive-pressure air produced at that end of the pump; and positive-pressure chamber 68 at the opposite end of the cylinder similarly includes an outlet fitting 84 receiving a tube 86 for outletting the positive-pressure air produced at that end of the pump. The positive-pressure air produced in chamber 66 is further outputted, via a tube 88 secured to a nipple 90 formed in end fitting 38, to another tube 92 for control purposes. The positive-pressure air outputted via tubes 88 and 92 is controlled by a solenoid valve 94, for control purposes as to be described more particularly below.

The humidifier unit 4 is in the form of a container 100 for receiving a supply of water 101 to humidify the positive-pressure air outputted by pump unit 2. The upper end of container 100 is closed by a top wall 102 having an inlet T-fitting 104 attachable to the two tubes 82, 86 outletting the positive-pressure air from the two output ends of the pump unit 2.

The humidifier unit 4 further includes an outlet fitting 110, attachable to the top wall 102 of container 100, for receiving a delivery tube 112 to deliver the humidified air to the patient. Delivery tube 112, which may be of any known construction, generally includes a mask (not shown) attachable over the mouth of the patient to receive the mechanical ventilation provided by the illustrated apparatus. Outlet fitting 110 is formed with a connector 114 receivable within an output port 116 formed in the top wall 102 of the humidifier container 100.

The humidifier unit 4 further includes a heater 120 in the form of an electrical coil carried at the lower end of an insulating sleeve 122. Electrical heater 120 is disposed so as to be completely immersed in the water within the humidifier container 100, and thereby to heat the water enclosed within sleeve 122. The open end of sleeve 122 is aligned with the inlet fitting 104 and with the outlet port 116, so that the air passing through the humidifier to the delivery tube 112 is humidified by the water 101 within sleeve 122 and heated by heater 120.

Sleeve 122 is made of plastic insulating material to conserve the heat of the water within the sleeve. The humidifier container 100 is of rectangular configuration, and the sleeve 122 is of cylindrical configuration having an outer diameter which is substantially less than the length of the humidifier container, e.g., substantially equal to its width as shown in FIG. 1, so as to occupy a fraction of the complete volume of the container. This arrangement thus concentrates the heat produced by its heater 120 to the portion of the water brought into direct contact with the air passing through the humidifier unit, and thereby decreases the power required for heating the water.

Outlet fitting 110 further includes an exhalation valve assembly, generally designated 130, for controlling the exhalation of the patient. Thus, the exhalation valve assembly 130 includes one or more (two being shown in FIG. 1) venting ports 132 for venting the delivery tube 112 to the atmosphere, and a valve member 134, in the form of a mushroom valve, movable either to an open position (shown in FIG. 1) or to a closed position with respect to a valve opening 136 formed in assembly 130.

Mushroom valve 134 is controlled by the pressure applied thereto from the positive-pressure chamber 66 via solenoid valve 94 and tube 92. Normally, mushroom valve 134 is in its open position as illustrated in FIG. 1, thereby establishing communication between delivery tube 112 and venting ports 132, to permit exhalation by the patient to the atmosphere via the latter venting ports; however, when a positive pressure is transmitted to the exhalation valve assembly 130 via tube 92, under the control of solenoid valve 94, mushroom valve 134 moves to its closed position with respect to valve opening 136. This blocks communication between delivery tube 112 and the venting ports 132, and thereby effects inhalation into the patient's lungs by the positive pressure of the air passing through tubes 82, 86, humidifier 100, and delivery tube 112.

The fluid collector unit 6 is attachable to the negative-pressure inlet connector 70 of the pump unit 2 whenever it is desired to withdraw fluids accumulating in the lungs of the patient. Thus, collector unit 6 includes a container 140 closed at its upper end by a top wall 142 formed with a fitting 144 connectable by a tube, shown schematically at 146, to the negative-pressure inlet 70 of pump unit 2, and with a further coupling 148 adapted to receive another tube, e.g., a catheter tube insertable into the lungs of the patient. Thus, when the fluid collector unit 6 is connected to the negative-pressure inlet 70 of the pump unit 2, the negative pressure produced by the pump unit draws out of the patient's lungs any fluid therein, which fluid is accumulated in container 140.

Normally the humidifier unit 4 and the fluid collector unit 6 may be detached from the pump unit 2 so as to permit convient portability and storage of the apparatus.

When the apparatus is to be used for providing mechanical ventilation of a patient, the humidifier unit 4 is attached to the pump unit 2, and the electric motor 14 is energized to produce positive-pressure air passing through the two outlet tubes 82, 86, via the humidifier unit 4, to the delivery tube 112 attached to the patient. The operation of motor 14 reciprocates the two pistons 18, 20 within cylinder 22, to pump the air from the positive-pressure chambers 62, 66 and 64, 68 at the opposite ends of cylinder 22, via their respective tubes 82, 86 into the humidifier unit 100, where the air is humidified by the water heated by the electrical heating element 120 before passing to the delivery tube 112.

The positive-pressure air thus applied to the delivery tube 112 is controlled by solenoid valve 94 and the exhalation valve assembly 130. Thus, whenever solenoid valve 94 is open, the positive-pressure in chamber 66 is applied via tube 92 to mushroom valve 134 to close valve opening 136, and thereby to effect inhalation of the air outletted from the pump unit 2 via tubes 82, 86 and humidifier unit 4 to the delivery tube 112; and when solenoid valve 94 is closed, mushroom valve 134 opens its valve opening 136 to establish communication between delivery tube 112 and the venting ports 132 to permit exhalation to the atmosphere by the patient.

It will thus be seen that a high degree of control may be effected merely be controlling solenoid valve 94 and also by controlling the speed of rotation of motor 14. During exhalation, the motor is turned off.

Further, the moisture content, and also the temperature, of the humidified air may be conveniently controlled by controlling electrical heater 120.

In emergencies, the pump unit 2 may be used alone, i.e., without the humidifier unit 4.

Whenever it is desired to withdraw fluids from the patient's lungs, the humidifier unit 4 is disconnected from the positive-pressure side of pump unit 2, and the fluid collector unit 6 is connected to the negative-pressure inlet 70. In addition, a catheter tube is applied to the inlet coupling 148 of the fluid collector unit 6, so that the negative pressure produced by the pump unit 2 is now applied to the patient's lungs via the catheter tube thereby drawing out fluid collected therein into the fluid collector unit 6.

FIG. 2 illustrates a solenoid drive, generally designated 200, which may be used in place of the rotary-motor drive 14 in FIG. 1. Thus, the solenoid drive 200 in FIG. 2 comprises a pair of pistons 202, 204 connected together by an armature 206 received within an electrical coil 208, such that energization of the coil reciprocates the two pistons within a cylinder 210. The two pistons 202, 204 include ports 212, 214 closed by umbrella valves 216, 218, respectively, for producing a negative-pressure on the inner sides of the pistons, and a positive pressure on the outer sides, as described above with respect to FIG. 1. The remainder of the structure of the pump unit, and the operation of the pump unit as well as of the remainder of the apparatus, is the same as described above with respect to FIG. 1.

FIG. 3 illustrates a variation in the construction of the flow path in order to damp the pulses generated by the reciprocating pistons. For example, the coupling illustrated in FIG. 3 could be applied between the outlet fittings 80, 84 and their outlet tubes 82, 86, and/or between the outlet coupling 110 and the delivery tube 112.

Thus, the coupling illustrated in FIG. 3, therein generally designated 300, comprises an air inlet 302 (e.g., coupled to outlet fitting 110), an air outlet 304 (e.g., coupled to the delivery tube 112) and a communicating orifice 306 between the two couplings. Inlet coupling 302 further includes an expansible, flexible bellows 308 just upstream of orifice 306, which tends to smooth out the air flow from the air inlet 302 to the air outlet 304.

FIG. 4 illustrates an embodiment of the invention particularly designed for use as a CPAP (continuous positive airway pressure) ventilator, for applying a positive pressure to a patient's lungs in order to help alleviate obstructive apnea during sleep. The illustrated apparatus comprises a pump unit schematically indicated at 402, and a heated humidifier unit schematically indicated at 404, both of which units may be of the construction as described above with respect to FIG. 1. Pump unit 402 includes a negative-pressure air inlet 410 and a positive-pressure air outlet 412 for delivering the pressurized air to the patient via a delivery conduit 414 having a connection 416 leading to the patient's mask (not shown). The pressurized air supplied to the patient via delivery conduit 414 is first passed through the heated humidifier unit 404 for heating and humidifying the air. The negative-pressure air inlet includes an air entry filter 418 for filtering the air supplied to the patient. In addition, the delivery conduit 414 may include an oxygen inlet 420 for adding oxygen to the air supplied to the patient.

The delivery conduit 414 further includes a one-way valve 422 to permit air flow only from the pump unit 402 to the patient connection 416. The delivery tube 414 further includes a spring-control PEEP (Positive End Expiratory Pressure) valve 424, which acts as a relief valve to release the pressure within the delivery conduit 414 to the atmosphere whenever that pressure rises above a predetermined peak value.

The ventilator apparatus illustrated in FIG. 4 further includes a pressure sensor 430, a pressure memory 432, and a comparator 434 controlling the pump unit 402. Sensor 430 is an electrical sensor which senses the pressure in the delivery conduit 414 and produces an electrical output corresponding to the sensed pressure. Memory unit 432 is an electrical storage device which stores the peak pressure sensed by sensor 430. Comparator 434 is an electrical comparator circuit which compares the current pressure sensed by sensor 430 with the peak pressure stored in memory unit 432. Comparator 434 is effective to energize the pump unit 402 whenever the sensed pressure in the delivery conduit 414 is below (e.g., 5-10% below in order to introduce hysteresis into the system) the peak pressure stored in memory unit 432, and to deenergize the pump unit whenever the sensed pressure is substantially equal to or above the stored peak pressure.

Thus, the pump is intermittently operated, sufficiently only to maintain the peak pressure, rather than continuously operated, thereby saving power, as well as oxygen and moisture when included in the pressurized air supplied to the patient.

It will be appreciated that many other variations, modifications and applications of the invention may be made.