Patent Publication Number: US-2007101994-A1

Title: Aerosol inhalation apparatus

Description:
BACKGROUND OF THE INVENTION  
      This invention relates to an aerosol inhalation method and apparatus which includes a disposable pulmonary inhalation device which includes means to generate properly sized aerosol particles.  
      The method and apparatus is especially useful for aerosolizing solutions to the proper aerosol particle size, and to collect aerosol particles in a proper filter to avoid environmental and/or ambient contamination. The device is suitable for delivering aerosols to a subject undergoing treatment or prophylaxis and to patients undergoing heart-lung transplants or chemotherapy.  
      Pulmonary dosing systems are efficient in delivering drugs. This can be important with respect the time spent by the patient and the support staff for each treatment and also with respect to reducing the expense of using extremely costly drugs. The efficiency refers not only to the efficiency of delivering drug to the patient but also to the efficiency of getting the delivered drug to penetrate deep into the lung of the patient to provide the needed therapy.  
      With respect to lung or heart-lung transplants, part of the protocol is to treat the lung with a drug such as Cyclosporin to suppress the immune system so that the patient does not reject the transplant. Chemotherapy involves the administration of toxic drugs. In both cases it is desirable to minimize, if not eliminate, escape of these drugs into the surrounding environment where they may be inhaled by attending medical personnel or others. With the treatment of diseases such as, but not limited to  Pneumocystis carinii  Pneumonia (PCP), it is also desirable not only to limit drug exposures to medically effective amounts but to minimize the amounts of aerosolized drug particles in the atmosphere.  
     SUMMARY OF THE INVENTION  
      An aerosol inhalation apparatus for supplying an aerosol mist to a patient comprises a disposable aerosol inhalation device including a nebulizer having a compressed air inlet and an outlet for an aerosol mist generated therein. A first conduit is in fluid communication with said outlet of said nebulizer. A second conduit having a first one-way valve therein for providing one-way fluid communication from ambient to an intersection is disposed between the first conduit and said second conduit. A third conduit provides fluid communication from the intersection between the first conduit and the second conduit and a Hepa filter is coupled to the third conduit. A second one-way valve is positioned in the third conduit for providing one-way fluid communication from the intersection to the ambient via the filter and a fourth conduit provides fluid communication between a mouthpiece for communicating with an airway of a patient and the intersection. The mouthpiece has a shut-off associated therewith which allows passage of the aerosol through the mouthpiece when the mouthpiece is within the patient&#39;s mouth, however when the shut-off is out of the patient&#39;s mouth the shut-off is closed to minimize possible contamination of the ambient by discharge of the aerosol through the mouth piece into the ambient. The apparatus includes a source of compressed air. A coupling for coupling said source of compressed air to said compressed air inlet of the nebulizer is provided for delivering compressed air thereto, whereby the one-way fluid communication from ambient to the intersection between the first conduit and the second conduit eases the patient&#39;s breathing by allowing inhalation independent of the source of compressed air.  
      In a further aspect of the apparatus, the shut-off arrangement comprises a two-way valve that is normally closed when outside a patient&#39;s mouth and opens when placed in a patient&#39;s mouth.  
      In a further aspect, the two-way valve is integral with the mouthpiece.  
      In still a further aspect of the shut-off, includes a normally closed valve and an operator associated with the mouthpiece, which operator detects when the mouthpiece is positioned in the patient&#39;s mouth and is connected to the normally closed valve to open the normally closed valve when the mouth piece is inserted in the patient&#39;s mouth.  
      In another embodiment of the shut-off arrangement, the shut-off arrangement is associated with a vent hole positioned downstream of the compressor and upstream of the nebulizer. In this embodiment, the shut-off arrangement comprises of a two-way valve having a valve closure which is normally biased to a first position preventing air from the compressor from flowing to the nebulizer. The two-way valve is movable from the first position to a second position allowing flow from the compressor to the nebulizer upon closing the vent hole so that when the mouthpiece is positioned in the patient&#39;s mouth and the vent hole is closed, preferably but not necessarily by the patient or medical attendant&#39;s finger being placed over the vent hole, the aerosol is delivered to the patient. Upon uncovering the hole before removing the mouthpiece, aerosol flow to and through the mouthpiece ceases.  
      In still a further aspect of the nebulizer, the nebulizer includes a reservoir portion for holding liquid therein which includes particles of drug therein, the drug being suited for site-specific delivery of the particles to the lungs of a patient.  
      In a specific aspect, the nebulizer has a reservoir portion for holding an emulsion containing particles of cyclosporine therein, the cyclosporine particles being especially suited for site-specific delivery to the lungs of a patient. 
    
    
     BRIEF DESCRIPTIONS OF THE DRAWINGS  
      Various other features and attendant advantages of the present invention will be more fully appreciated as the same becomes better understood when considered in conjunction with the accompanying drawings, in which like reference characters designate the same or similar parts throughout the several views, and wherein:  
       FIG. 1  is a perspective view of a first exemplary embodiment of an aerosol inhalation apparatus constructed in accordance with the present invention.  
       FIG. 2  is a fragmentary perspective diagrammatic view of a portion of the apparatus of  FIG. 1  illustrating a nebulizer with its internal baffle which is suitable for use in the aerosol inhalation apparatus illustrated in  FIG. 1 .  
       FIG. 3  is a fragmentary perspective diagrammatic view of a conduit and filter arrangement, which may be used as a substitute for a portion of the aerosol inhalation apparatus of  FIG. 1 , in accordance with a second exemplary embodiment of the present invention.  
       FIG. 4  is a fragmentary perspective diagrammatic view of a conduit and filter arrangement, which may be used as a substitute for a portion of the aerosol inhalation apparatus of  FIG. 1 , in accordance with a third exemplary embodiment of the present invention.  
       FIG. 5  is a fragmentary perspective diagrammatic view of a conduit and filter arrangement, which may be used as a substitute for a portion of the aerosol inhalation apparatus of  FIG. 1 , in accordance with a fourth exemplary embodiment of the present invention.  
       FIG. 6A  is a side view of a first embodiment of a mouthpiece valve showing the mouthpiece valve open.  
       FIG. 6B  is a side view of the mouthpiece of  FIG. 6A  showing the mouthpiece valve of  FIG. 6A  closed.  
       FIG. 7A  is a side view of the mouthpiece of a second embodiment of a mouthpiece valve showing the mouthpiece open.  
       FIG. 7B  is a side view of the mouthpiece valve of  FIG. 7A  showing the mouthpiece valve closed.  
       FIG. 8A  is a side view of a third embodiment of a mouthpiece valve showing the mouthpiece valve open.  
       FIG. 8B  is a view taken along lines  8 B- 8 B of  FIG. 8A .  
       FIG. 8C  is a side view of the mouthpiece valve of  FIGS. 8A and 8B  showing the mouthpiece valve open.  
       FIG. 8D  is a section view taken along lines  8 D- 8 D of  FIG. 8C .  
       FIG. 8E  is a view similar to  FIG. 1 , but showing the mouthpiece prior to insertion.  
       FIG. 9A  is a side elevation of a fourth embodiment of a mouthpiece valve showing the mouthpiece valve open.  
       FIG. 9B  is a side view of the mouthpiece valve of  FIG. 9A  showing the mouthpiece valve closed.  
       FIG. 10  is a side view of a sensor in the mouthpiece for allowing the compressor to provide compressed air to the nebulizer of the apparatus only when the mouthpiece is in the patient&#39;s mouth.  
       FIG. 11A  is a side view of a trigger-type mechanism for blocking airflow from a motor compressor to the nebulizer and showing the airflow unblocked.  
       FIG. 11B  is a view similar to  FIG. 11A  but showing the airflow to the nebulizer blocked. 
    
    
     DETAILED DESCRIPTION  
       FIG. 1  illustrates a first embodiment of an aerosol inhalation apparatus suitable for administering toxic drugs during chemotherapy and suitable for administering drugs for suppressing autoimmune responses to lung and heart-lung transplants. The apparatus of  FIG. 1  is also useable for treating and/or prophylaxis of pneumonia and other disorders of the lungs and other diseases, and for treating disorders involving medications which can be dispensed in aerosol form.  
      The apparatus of  FIG. 1  includes an electric a.c. motor driven compressor, the motor-compressor being designated generally by the numeral  10 . In a realized embodiment, a motor-compressor unit available commercially under Model designation MDA-P 109-AA from the Gast Mfg. Corp. of Benton Harbor, Mich. was used. The motor-compressor  10  is used to generate compressed air at a pressure of about 35-50 (and preferably 40) pounds per square inch and, in use provides a flow rate of about 8 to 10 liters per minute thruput to a patient. Ambient air is supplied to the motor-compressor  10  via an inlet illustrated by a tubular member  9 . The compressed air from the motor-compressor  10  exits from a threaded fitting  111  and into a flexible conduit  12 , the output end of which is positioned over an end of a T-shaped coupler  13  having an internal bore in fluid communication with an end of a further flexible conduit  19 , the other arm  14  of T-shaped coupler  13  is provided with a bore that provides a vent opening  15  for fluid communication from the internal bore within the coupler  13  to the ambient. The purpose of the vent opening  15  is to provide a means for allowing the compressed air from the motor-compressor  10  to exhaust to the ambient unless a person treating a patient or the patient places a finger over the vent opening  15 , causing the compressed air from the conduit  12  to enter the conduit  19  and be passed into a baffled nebulizer  16 , via a hollow stem  17 . The baffled nebulizer  16  is shown in more detail in  FIG. 2  to which reference is to be made hereinbelow. The baffled nebulizer  16  contains a toxic substance, such as for example, cyclosporin, for suppressing autoimmune responses during transplant procedures, or a chemotherapy drug.  
      In fluid communication with the interior of the nebulizer  16  is four-way conduit assembly formed as a integral unit  18  of a plastic. The integral unit  18  includes a first conduit  20  which fits over an outlet  21  from the nebulizer  16 . A second conduit  22  having a one-way flap valve  23  therein provides a one-way path for ambient air to enter the unit  18 , as indicated by the arrowheaded line  32 , and mix with the mist and compressed air from the nebulizer  16 , an intersection being provided between the first conduit  20  and the second conduit  22 . A one-way valve  23  prevents the aerosol mist and air from the motor-compressor  10  as well as exhaled materials from a patient from being passed to the ambient.  
      The air supplied from the ambient via the one-way valve  23  and the conduit  22  with the aerosol mist from the nebulizer  16  is inhaled by the patient via a fourth conduit  24  and through a mouthpiece  26  provided with a tubular connection portion  25  into the patient&#39;s mouth  29 . The patient or a therapist merely places his or her finger over the vent opening  15  in the coupler  13  to produce the aerosol mist from a solution containing the treating agent which has been positioned within a reservoir portion of the nebulizer  16 . It is to be understood that a trigger-operated valve arrangement or the like can be used in place of the fitting  13 . In either case the treating agent, which is expensive, is conserved and the breathing of the patient made easier. A third conduit  27  extends from the intersection of the conduits  20 ,  22  and  24  to a Hepa filter  28 , via a one-way valve  29  which allows the patient to exhale into the ambient as indicated by the arrowheaded line  31 , the filter  28  removing the aerosolized treating agent as well as microorganisms, including viruses. In a realized embodiment of the apparatus, a commercially available filter sold under the Model No. 0811 by Amici Inc. of 740 Walnut Street, Rogersford, Pa. was used to filter out microorganisms. Thus, protecting the environment and personnel from the patient.  
      In a now preferred embodiment of the invention when the nebulizer  16  uses a toxic material such as cyclosporin, the filter  28  is an HEPA filter which filters out toxic materials using absorbers such as activated charcoal. The filter  28  could also employ an electrostatic precipitator. A suggested HEPA filter is an ISO Gard Hepa Light Filter, such as Code ISG-HUD  28022 , available from Hudson RCI of Temenla, Calif.  
      In the event one wishes to place the patient at some distance from the unit  18 , the mouthpiece  26  may be removed from the end of the fourth conduit  24  and a flexible tubular conduit  30  positioned between the mouthpiece  26  and the open end of the conduit  24 . The unit consisting of the nebulizer  16 , the filter  28 , the unit  18  and the mouthpiece  26 , as well as the conduit  30 , can be discarded after use and is intended for single patient use.  
      The details of the preferred nebulizer  16  ( FIG. 1 ) are illustrated in  FIG. 2 , a cross-section having been taken axially through the nebulizer  16 . The nebulizer  16  includes the stem-like, tubular conduit  17  which is positioned into the upstanding portion of the flexible conduit  19  ( FIG. 1 ). The tubular conduit  17  is fluid communication with a vertically extending tubular member  136  which has a narrowing conical end portion terminating in an opening  137 , compressed air under positive pressure from the motor-compressor  10  ( FIG. 1 ) is to pass through the tubular member  136  and out the small opening  137 . The opening  137  exhausts into a chamber  138  which is in fluid communication with a downwardly extending tubular member  140  having an opening in its lower end  141  so as to be beneath the level of liquid in the nebulizer  16  which is to be placed in the bottom portion  142 , which acts as a reservoir, of the interior of the nebulizer  16 . The solution which is to be placed in the bottom portion of the nebulizer  16  is placed in the nebulizer by unthreading its upper portion  147  from the lower portion and placing the solution into a chamber  148  defined by the lower portion.  
      In close vicinity to the opening  137  and in the top portion of the chamber  138  is an aperture  144  having a relatively larger diameter portion at its uppermore end. The aperture  144  is positioned in close vicinity and immediately beneath a protrusion  145  which has a generally smooth arcuate outer surface. Positioned over the above-discussed structure and above the protrusion  145  is a baffle  146 . The baffle  146  is force-fit over the structure defined by the tubular members  136  and  140 , the chamber  138  and the protrusion  145 . The baffle  146  has a smooth, arcuate inner surface on which droplets of liquid formed from aerosol mist particles having greater than three microns in diameter are collected, these particles running down the inner side walls of the baffle  146  so as to again collect in the bottom portion  142  of the nebulizer  16 . The particle size is a function of nebulizer type, baffling and air pressure, these parameters are desirably selected to provide particles in the selected range which results in good alveolar deposition. The particles have a Gaussian distribution within the range. The range may be changed to effect a more effective deposition at diseased sites. The nebulizer  16  is constituted by the two major portions, the upper portion  147  being threadedly connected to the bottom portion, the upper portion defining internally a fluid passageway from the interior chamber  148  of the bottom portion of the nebulizer  16  and defining a passageway from the aerosol containing chamber  148 . A throttle  150  is provided in the passageway between the interior chamber  148  and the tubular conduit  21 , the passageway constituting a pre-determined restriction, so far as cross-section is concerned, to allow selection of the desired and/or prescribed amount of material which a patient is to inhale during a given treatment session. The throttle  150  is constituted by a plurality of downwardly extending triangularly shaped extensions  150   a - 150   c , these extensions being bendable (when subjected to a heat treatment) so as to provide selectively a particular opening area from the chamber  148  into the rigid tubular conduit  21 . As illustrated, the triangular extensions  150   a - 150   c  are shown unbent in positions providing a maximum opening area. Were one to desire a more restrictive opening, so as to subject a subject to a lesser dose of material, the end portions of the triangular extensions  150   a - 150   c  would simply be bent inwardly so as to make the opening smaller in area. As a practical matter a number of threaded upper members  147 , possibly color coded, could be provided so that a user could select which throttle opening area feature was desired in a given case.  
      The device of  FIG. 3 , like the device of  FIG. 1 , includes a baffled nebulizer  16  provided with a hollow stem  17 . The baffled nebulizer  16  may be constructed as shown in  FIG. 2 .  
      The device shown in  FIG. 3  includes an integral unit  18  which is identical to the unit  18  ( FIG. 1 ). The device differs in that a third one-way valve  33  is positioned within the conduit  20  for allowing aerosol mist to flow from the nebulizer  16  into the intersection provided between the first conduit  20  and the second conduit  22 , as illustrated diagramatically by an arrowheaded line  40 . The one-way valve  23  prevents material exhaled by a patient from entering the nebulizer  16 . If desired the device  18  as shown in  FIG. 3  may be used in conjunction with the flexible conduit  30  ( FIG. 1 ).  
       FIG. 4  illustrates a third embodiment of an aerosol inhalation device. The device of  FIG. 3 , like the device forming a portion of the apparatus illustrated in  FIG. 1 , includes a baffled nebulizer  16  provided with a hollow stem  17 , which may be placed into an open end of the flexible conduit  19  ( FIG. 1 ). The baffled nebulizer  16  is shown in detail in  FIG. 2 .  
      In fluid communication with the interior of the nebulizer  16  is a three-way passage formed as a integral unit of a plastic. The integral unit includes a first conduit  37  which fits over an outlet  21  from the nebulizer  16 . A second conduit  39  having a one-way flap valve  23  therein provides a one-way path for ambient air to enter the unit and mix with the mist and compressed air from the nebulizer  16 , an intersection being provided between the first conduit  37  and the second conduit  39 . The one-way valve  23  prevents the aerosol mist and air form the motor-compressor  10  ( FIG. 1 ) from being passed to the ambient, as illustrated diagramatically by an arrowheaded line  32 .  
      The air supplied from the ambient via the one-way valve  23  and conduit  39  with the aerosol mist from the nebulizer  16  is inhaled by the patient via a fourth conduit  35  and a mouthpiece  26  provided with a  26 , the patient or a therapist merely placing his or her finger over the bore  15  ( FIG. 1 ) in the coupler  13  ( FIG. 1 ) to produce the aerosol mist from a solution containing the treating agent which has been positioned within the nebulizer  16 . A third one-way valve  36  is provided within the fourth conduit  35  to allow air and aerosolized mist to flow towards the mouthpiece  26 , as illustrated by the arrowheaded line  38 , while preventing reverse flow. A third conduit  34  extends from an intersection with the fourth conduit  35  to a toxic material or a bacteria-viral filter  28 , via a one-way valve  29  which allows the patient to exhale into the ambient, the filter  28  removing microorganisms, including viruses as well as the aerosolized treating agent. The device shown in  FIG. 4  can be discarded after use and is intended for single patient use.  
       FIG. 5  illustrates a fourth embodiment of an aerosol inhalation device suitable for treating and/or prophylaxis of pneumonia, and the like. The device of  FIG. 5 , like the device forming a portion of the apparatus of  FIG. 1 , includes a baffled nebulizer  16  which includes a hollow stem  176  which is to be placed into the open end of the flexible conduit  19  ( FIG. 1 ).  
      In fluid communication with the interior of the nebulizer  16 , as shown in  FIG. 5 , is a conduit  42  which extends downwardly from an intersection with a tubular extension  41  fitted into the open end of the second conduit  22  of the unit  18  which is constructed identically to the disposable unit  18 . A third one-way valve  46  is positioned within the tubular extension  41  to permit intake of air from ambient, as indicated diagramatically by the arrowheaded line  44 , while preventing outflow of exhalent material, compressed air and mist. The integral unit  18  includes a first conduit  20  which may fit over the outlet  21  from the nebulizer  16 , were the nebulizer  16  removed from its illustrated position, and a cap  47  removed from the open end of the conduit  20 . Were this done and the extension  41  removed, the resulting structure would be identical to the device of  FIG. 1 . The second conduit  22 , having a one-way flap valve  23  therein, provides a one-way path for ambient air, the mist and compressed air from the nebulizer  16 , an intersection being provided between the first conduit  20  and the second conduit  22 . The one-way valve  44  prevents the aerosol mist and air from the motor-compressor  10  from being passed to the ambient when configured as shown in  FIG. 5  and the one-way valve  23  permits passage of the aerosol mist, compressed air and ambient to the patient via the second conduit  22  and the fourth conduit  24 , as indicated by the arrowheaded line  32 .  
      The air supplied from the ambient via the one-way valves  23  and  46 , via the conduit  22  with the aerosol mist from the nebulizer  16  is inhaled by the patient via the fourth conduit  24  and the mouthpiece  26  provided with the tubular connection portion  25 , the patient or a therapist merely placing his or her finger over the bore  15  ( FIG. 1 ) in the coupler  13  ( FIG. 1 ) to produce the aerosol mist from a solution containing the treating agent which has been positioned within the nebulizer  16 . The fourth conduit  27  extends from the intersection of the conduits  20 ,  22  and  24  to a bacteria-viral filter  28 , via the one-way valve  29  which allows the patient to exhale into the ambient, as indicated diagramatically by the arrowheaded line  31 . The filter  28  removes microorganisms, including viruses, and the aerosolized treating agent. The unit consisting of the nebulizer  16 , the filter  28 , the unit  18 , the extension  41  with its valve  46  and the mouthpiece  26  can be discarded after use and is intended for single patient use. The embodiment illustrated in  FIG. 5  allows one to, in effect, select one of two treatment configurations from one group of parts. The configurations are essentially the configurations shown in  FIGS. 3 and 4 .  
      The apparatus and device of the present invention is suitable for delivery of medications other than the ones mentioned above. Among the medications which may be appropriate for aerosol delivery are cyclosporine, trimetrexate, dapsone, fansidar, bactrium and leucovorin, as well as various chemotherapy medications. Many different types of one-way valves could be used in practicing the invention. The valve disclosed in the copending application Ser. No. 928,826, now U.S. Pat. No. 4,703,753 assigned to assignee of applicant, has been found in realized embodiments of the invention to be both suitable and inexpensive.  
      In each of the four embodiments of  FIGS. 1-5 , the mouth piece  26  has a shut-off arrangement  200  associated therewith which is normally closed to prevent the aerosol from emission through the mouthpiece into the ambient when the mouth piece is not in the patient&#39;s mouth.  
       FIGS. 6A and 6B  show a first embodiment  202  of the shut-off arrangement  200  wherein the tubular connecting portion  25  is configured as a flexible tube  204  having a spring  206  normally biasing the valve  202  closed. As is shown in  FIG. 6A , when the mouthpiece  26  is the patient&#39;s mouth, the valve  202  is open against the bias of spring  206 , and as shown in  FIG. 6B  when the mouthpiece  26  is out of the patient&#39;s mouth, the tube  204  is crimped causing the valve  202  to close preventing the aerosol from passing through the mouthpiece  26 .  
       FIGS. 7A and 7B  show a second embodiment  302  of the shut-off arrangement  200  wherein the tubular connecting portion  25  has a valve  304  therein which is normally closed by fluid pressure from the motor-compressor  10  applied through conduit  12  as is shown in  FIG. 7B . The valve  304  comprises a valve seat  306  having an opening  307  therethrough and a valve head  308  aligned with the valve opening  307  that normally closes the opening  307  when the motor compressor  10  is supplying pressure through outlet  21  downstream of the nebulizer  16 . The valve head  308  has a stem  310  extending through the valve opening  307  and into the mouthpiece  26  where the patient&#39;s tongue exerts sufficient force on the valve stem  310  to overcome the pressure upstream of the valve  302  letting the aerosol flow through the mouthpiece. Upon removing the mouthpiece  26  from the patient&#39;s mouth, pressure from the outlet  21  of the nebulizer closes the valve  304  preventing the aerosol from passing through the mouthpiece  26  into the ambient.  
       FIGS. 8A-8D  show a third embodiment  402  of the shut-off arrangement  200  wherein the tubular connecting portion  25  and the mouthpiece  26  are rotatable with respect to one another preferably by about 90°. The valve  402  comprise an opening  404  at the downstream end  405  of the tubular connection portion  407  that is closed by a shutter  406  which is integral or unitary with the mouthpiece  26  and is rotatable with the mouthpiece to open and closed the valve opening  404  by uncovering and covering the valve opening  404 . The shutter  406  is normally biased to cover the valve opening  404  by a spring  408  preferably in the form of an elastic band. When the mouthpiece  26  is twisted or rotated about axis  410  with respect to the tubular connecting portion  407 , the valve opening  404  is uncovered so as allow the aerosol to be breathed. Generally, the tubular connecting member  26  is held in a position as is shown in  FIGS. 1 and 3 - 5  with the nebulizer below the mouthpiece  25  and the tubular connecting member ( 25 ,  407 ). In order to insert the mouthpiece  25  into the patient&#39;s mouth  29 , the mouthpiece must be twisted about 90° from the at rest position of  FIG. 8E  to the position shown in  FIGS. 1 and 3 - 5 . When the mouthpiece is withdrawn from the patient&#39;s mouth  29  the spring  408  returns the mouthpiece  25  from the position of  FIGS. 1 and 3 - 5  to the position of  FIG. 8E .  
       FIGS. 9A and 9B  illustrate a fourth embodiment of the valve  200  wherein the valve is a bite valve  500  that is opened upon a patient inserting the mouthpiece  26  into their mouth  29  to breath therethrough, as is seen in  FIG. 9A . In this embodiment, the patient bites down on a flexible insertion portion  502  that pivots a lever  504  to urge a normally closed valve member  506  to open against the bias of a spring  508 . As is seen in  FIG. 9B , when the lever  504  is not pivoted by the patient&#39;s bite, the normally closed valve member  206  remains closed stopping flow of aerosol through the mouthpiece  26 . Consequently, when the mouthpiece  26  is taken out of the patient&#39;s mouth  29  flow through the mouthpiece into the ambient does not occur.  
       FIG. 10  shows an alternative embodiment wherein a sensor  600  extends into the mouthpiece  26  and senses that the mouthpiece is in the patient&#39;s mouth  29 . The sensor is preferably electronic and may respond to any number of stimuli. An example of stimuli is pressure of the patient&#39;s mouth  29  (teeth, lips or tongue) against the sensor  600 , which pressure is converted to an electrical signal which closes contacts in a relay  602  that supplies current to the motor compressor  10 . When the contacts of the relay  602  are not closed, the motor compressor  10  does not supply air to the nebulizer  16 . So unless the mouthpiece  26  is within the patient&#39;s mouth  29 , the relay is open and the compressor is not operating. The sensor is preferably connected to the relay  602  by line  604 . While the line  604  is preferably an electrical line, the line for example may be pneumatic.  
      Referring now to  FIGS. 11A and 11B , there is shown a trigger-type cut-off  700  disposed between the compressor  10  and the nebulizer  16 . The trigger-type cut-off  700  is positioned adjacent to the vent hole  15  in chamber  702  provided between the compressed air lines  12  and  14 . In  FIG. 11A , when the vent hole  15  is closed by pushing a button  703  with one&#39;s fore finger, a right hand surface  704  of a flap  705  blocks compressed air from the compressor  10  from flowing out the vent  15  and allows the compressed air to flow through an opening  707  in the flap  705  to the nebulizer  16 . Upon releasing the button  703 , a spring  710  biases the button  703  out from the chamber  702  pulling the flap to the position of  FIG. 11B . As is shown in  FIG. 11B , the flap  705  disengages from the edge  712  of a projection  714 , opening a gap  716  through which the compressed air passes to vent through the vent hole  15 . The left hand surface  718  of the flap  705  then seals against the edge  720  of a projection  722  to prevent the compressed air from flowing to the nebulizer  16 . In the arrangement of  FIGS. 11A and 11B , the vent hole  15  is normally open and is closed only when the compressed air is redirected through the nebulizer  16  by pressing the button  703 , as is seen in  FIG. 11A .  
      If a mask is used covering both the nose and mouth of the patient then the valve  202  may be opened by pressure used to keep the mask sealed and in place, for example by a head strap which opens the valve  202  when slightly tensioned.  
      In another embodiment, a valve is disposed in the first conduit  20  or the fourth conduit  25  to interrupt flow through the open end of the mouthpiece  25 . In this embodiment a small pneumatic or electrical sensor, detects the presence of the patient&#39;s mouth and sends a signal to the valve to open.  
      From the foregoing it will be seen that applicants&#39; pulmonary inhalation apparatus and device provides for a disposable aerosol inhalation device which generates properly sized particles having provisions for proper valving, and ease of operation. Further, the apparatus and device has been described with reference to particular embodiments which have been set out, not by way of limitation, but by way of illustration. The embodiments of the apparatus and the device can be used in conjunction with ventilators and respirators, appropriate controlled valves being added. It is to be appreciated that many other embodiments and variants are possible within the spirit and scope of the invention, its scope being defined by the appended claims.