Patent Publication Number: US-2022211960-A1

Title: A system for delivering inhaled therapies

Description:
FIELD OF THE INVENTION 
     The present invention relates to medical devices for preventing and treating respiratory diseases and, more specifically, to inhalers provided with inlet and outlet passages blockable and releasable in an alternate manner. 
     BACKGROUND OF THE INVENTION 
     WO2015186124 discloses a pulsating therapeutic inhaler generating pneumatic pulses for treating respiratory disorders. The aforesaid inhaler comprises: (a) a linear passage having an elongate axis; the linear passage configured to conduct a fluid flow in a laminar manner; (b) a patient interface fluidly connectable to the patient&#39;s respiratory tract having an aperture fluidly connectable to the passage; and (c) a shutter disposed between the passage and the aperture configured to modulate a fluid pressure within the fluid flow; the shutter comprising a disc having at least one cutout and rotating about an axis parallel to the passage axis. The cutout has four cornered perimeter thereof with two side portions and two circumferential arcs configured relative to the rotation axis. The side portions are circumferentially anti-symmetrical relative to the aperture. 
     The pulsing inhalers know in the art have an air passage feeding an airflow into a patent&#39;s airway. During the inhalation phase air fed by the inhaler flows into the patient&#39;s airway. At the phase of exhalation a part of exhaled air regresses into the feeding air passage. The described effect is known of a dead-space effect. Thus, there is a long-felt need of providing an inhaler minimizing the aforesaid effect and discharging the exhaled air all-out. 
     SUMMARY OF THE INVENTION 
     It is hence one object of the invention to disclose an inhaler comprising: (a) a first passage having a first open end and a second open end; (b) a pressure source configured for generating an airflow; said pressure source connected to said first open end of said first passage; (c) a rotating shutter configured for blocking and releasing said airflow; (d) a mouthpiece being in fluid communication with second open end of said first passage; said mouthpiece configured for delivering a modulated airflow to a patient&#39;s airway. 
     It is a core purpose of the invention to provide the inhaler comprising a second passage having first open end and a second open end. The first open end of said second passage is in fluid communication with said mouthpiece. The second open end of said second passage is vented to ambient air. The first and second passages are arranged such that said rotating shutter blocks and releases said first and second passages in an alternate manner. 
     Another object of the invention is to disclose the first and second passages arranged nearby in a parallel manner. 
     A further object of the invention is to disclose the first passage arranged within the second passage. 
     A further object of the invention is to disclose the first passage having a passage gate valve configured for controlling a flow rate within said first passage. 
     A further object of the invention is to disclose the first passage having a branch inlet configured for connecting a humidifier unit. 
     A further object of the invention is to disclose the nebulizer gate valve selected from the group consisting of a mechanically actuated valve, an electrically actuated valve, a pneumatically actuated valve, a magnetically actuated valve and any combination thereof. 
     A further object of the invention is to disclose the nebulizer branch inlet comprising a cylinder reciprocatively displaceable within said nebulizer branch inlet between an open position at an inhalation phase and a closed position at an exhalation phase and. In said open position, said nebulizer is fluidly connected with said mouthpiece; said closed position blocks fluid communication between said nebulizer and said mouthpiece. 
     A further object of the invention is to disclose the nebulizer which is connectable to an air pressure source. 
     A further object of the invention is to disclose a connection of said air pressure source to said nebulizer comprising an air pressure source gate valve. 
     A further object of the invention is to disclose the nebulizer connectable to an oxygen source. 
     A further object of the invention is to disclose the inhaler comprising a control unit configured for controlling an element selected from the group consisting of said shutter, said passage gate valve, said humidifier gate valve, air pressure source gate valve and any combination thereof; said control unit is preprogrammed for implementing a predetermined treatment protocol. 
     A further object of the invention is to disclose the inhaler comprising a pressure sensor providing a feedback to said control unit during implementing said predetermined treatment protocol. 
     A further object of the invention is to disclose the inhaler comprising a control unit configured for controlling an element selected from the group consisting of said shutter, said passage gate valve, said humidifier gate valve, air pressure source gate valve, said airflow heater and any combination thereof; said control unit is preprogrammed for implementing a predetermined treatment protocol. 
     A further object of the invention is to disclose the inhaler comprising a sensor selected from the group consisting of a pressure sensor located at said first open end of said first passage and configured for detecting air pressure provided by said pressure source, a flow rate sensor located at said first open end of said first passage and configured to detect an airflow rate provided by said pressure sensor, a presence sensor located at said humidifier branch inlet and configured for detecting presence of said humidifier, a humidity sensor located at said humidifier branch inlet and configured for detecting air humidity provided by said humidifier, a barometric sensor configured to detect barometric pressure of ambient air, a an oxygen sensor located at said oxygen source, a presence sensor located at said nebulizer branch inlet and configured for detecting presence of said nebulizer, a pressure sensor located at said mouthpiece and configured for detecting air pressure within said mouthpiece, a lung gases sensor configured for detecting a gas composition of exhaled air, a humidity sensor located at said mouthpiece and configured for detecting air humidity within said mouthpiece, a temperature sensor located at said mouthpiece and configured for detecting temperature within said mouthpiece, an acoustic sensor located at said mouthpiece and configured for detecting breathing sounds within said patient&#39;s airway, an acoustic sensor located at a patient&#39;s body and configured for detecting breathing sounds within said patient&#39;s airway and any combination thereof. 
     A further object of the invention is to disclose a method of preventing and treating respiratory diseases; said method comprising steps of: (a) providing an inhaler further comprising (i) a first passage having a first open end and a second open end; (ii) a pressure source configured for generating an airflow; said pressure source connected to said first open end of said first passage; (iii) a rotating shutter configured for blocking and releasing said airflow; (iv) a mouthpiece being in fluid communication with second open end of said first passage; said mouthpiece configured for delivering a modulated airflow to a patient&#39;s airway; (v) said inhaler comprises a second passage having first open end and a second open end; said first open end of said second passage is in fluid communication with said mouthpiece; said second open end of said second passage is vented to ambient air; said first and second passages are arranged such that said rotating shutter blocks and releases said first and second passages in an alternate manner; (b) providing pneumatic pulses to said mouthpiece by means of blocking and releasing said airflow within said first passage; (c) venting said mouthpiece to ambient air. Steps b and c are executed in an alternate manner. 
     A further object of the invention is to disclose the step of providing pneumatic pulses comprising controlling a flow rate within said first passage by a passage gate valve configured for. 
     A further object of the invention is to disclose the step of providing pneumatic pulses comprising humidifying said airflow within said first passage by a humidifier connected to a branch inlet. 
     A further object of the invention is to disclose the step of humidifying said airflow comprising controlling a flow rate between said humidifier unit and said first passage by a humidifier gate valve. 
     A further object of the invention is to disclose the sub-step of humidifying said airflow comprising controlling a flow rate between said humidifier unit and said first passage by a humidifier gate valve. 
     A further object of the invention is to disclose the step of providing pneumatic pulses comprising a sub-step of nebulizing a medicament into said second passage. 
     A further object of the invention is to disclose the sub-step of nebulizing said medicament comprising positioning a reciprocatively displaceable cylinder within said nebulizer branch inlet into an open position at an inhalation phase and into a closed position at an exhalation phase such that said nebulizer is fluidly connected with said mouthpiece in said open position and a fluid communication between said nebulizer and said mouthpiece is blocked in said closed position. 
     A further object of the invention is to disclose the method comprising a step of a control unit configured for controlling an element selected from the group consisting of said electric motor, said passage gate valve, said humidifier gate valve and any combination thereof; said control unit is preprogrammed for implementing a predetermined treatment protocol. 
     A further object of the invention is to disclose the inhaler comprising a step of controlling said element feedback selected from the group consisting of said electric motor, said passage gate valve, said humidifier gate valve and any combination thereof comprises getting feedback from a pressure sensor. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       In order to understand the invention and to see how it may be implemented in practice, a plurality of embodiments is adapted to now be described, by way of non-limiting example only, with reference to the accompanying drawings, in which 
         FIG. 1  is a schematic diagram of an inhaler provided with inlet and outlet passages blockable and releasable in an alternate manner; 
         FIG. 2  is a schematic diagram of an inhaler provided with a nebulizer; 
         FIGS. 3 a  to 3 d    illustrate operation a gate valve; 
         FIG. 4  is a schematic diagram of a sensor arrangement in an inhaler; 
         FIG. 5  is a schematic diagram of an internal heater within an air passage; 
         FIGS. 6 a  to 6 c    are schematic diagrams of a pipe arrangement in a mouthpiece of an inhaler; and 
         FIGS. 7 a  to 7 d    are schematic diagrams of alternative embodiments of a nebulizer gate valve in closed and open positions. 
     
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
     The following description is provided, so as to enable any person skilled in the art to make use of said invention and sets forth the best modes contemplated by the inventor of carrying out this invention. Various modifications, however, are adapted to remain apparent to those skilled in the art, since the generic principles of the present invention have been defined specifically to provide an inhaler for preventing and treating respiratory diseases and a method of doing the same. 
     Reference is now made to  FIG. 1  presenting a schematic diagram of inhaler  100  having housing  150  accommodating all its components. Specifically, an air flow from blower  20  is conducted by passage  10  which is in fluid communication with mouthpiece  50 . A flow rate of the airflow is controlled by motorized gate valve  120  driven by actuator  110 . Passage  10  is provided with humidifier branch inlet  80  allowing fluid communication between a humidifier (nor shown) connectable to humidifier branch inlet  80 . Second passage  40  is provided with nozzle  30 . In addition, second passage  40  is in fluid communication with nebulizer branch inlet  90  configured for connecting the humidifier thereto. Electric motor  70  drives rotating disc  60  having a cutout (not shown) such that first and second passages  10  and  40 , respectively, are arranged such that rotating disc  60  blocks and releases first and second passages  10  and  40  in an alternate manner. It should be noticed that an excess pressure created by blower  20  when the cutout (not shown) on rotating disc  60  coincides with first passage  10  is vented to surrounding atmosphere when the cutout coincides with second passage  40 . The exhaled air accommodated only in mouthpiece  50  is potentially pressurized back into the patient&#39;s airway. In other words, the dead-space effect is minimized. 
     Control unit  160  is configured for controlling electric motor  60 , passage gate valve  120 , humidifier gate valve  140  and air pressure source gate valve  270 . Control unit  160  is preprogrammed for implementing a predetermined treatment protocol. Pressure sensor  65  provides a feedback to control unit  160  during implementing the predetermined treatment protocol. 
     Reference is now made to  FIG. 2  presenting arrangement  200  for connecting a nebulizer  220  to the inhaler  100  (not shown). The aforesaid nebulizer is connected to nebulizer branch inlet  40  having a cylinder reciprocatively displaceable within nebulizer branch inlet  40  between closed position  210  at an exhalation phase and open position  210   a  at an inhalation phase. In open position  210   a,  nebulizer  220  is fluidly connected with mouthpiece  50 . Pipes  240  and  250  are connectable to an oxygen source and a pressurized air, respectively. An oxygen flow rate is controlled by tap  230 . Gate valve  270  driven by actuator  260  is closable at inhalation phase and openable at exhalation phase. Numeral  245  refers to an oxygen sensor detecting an oxygen gas flow via pipe  240 . 
     Reference is now made to  FIGS. 3 a  to 3 d    illustrating operation of gate valves. As shown in  FIG. 3 a   , the aforesaid gate valves are shown as shutters  120 ,  140  and  270 . Shutter  120 / 140 / 270  is configured for opening and blocking passages  10 / 80 / 280 . Shutter  120 / 140 / 270  is driven by actuators  110 / 130 / 260 .  FIGS. 3 b  to 3 d   , successive positions of shutter  120 / 140 / 270  which gradually blocks passage  10 / 80 / 280 . 
     Reference is now made to  FIG. 4  presenting a schematic diagram of a sensor arrangement in an inhaler. The inhaler can include at least one of the sensors provided below. 
     Airflow from blower  20  within passage  10  is characterized by air pressure detected by pressure sensor  210  and flow rate detected by flow rate sensor  211 . Numeral  209  refers to a barometric sensor configured for measuring pressure of ambient air. The obtained value of barometric pressure is used by control unit in calculation of air pressure provided into mouthpiece  50 . 
     Mouthpiece  50  can be provided with air pressure sensor  203  and flow rate sensor  202  detecting local air pressure and flow rate, respectively. Local relative humidity within mouthpiece  50  can be obtained by means of humidity and temperature sensors  205  and  206 , respectively. 
     Acoustic sensor  201  located within mouthpiece  50  is designed for obtaining an acoustic pattern of inhalation/exhalation phases via the air flow. Contrary to this, acoustic sensor  190  can be placed on a patient&#39;s chest. The acoustic pattern obtained by sensors  201  and/or  190  can be used for adaptation of a therapeutic protocol to a specific patient&#39;s condition. Numeral  204  refers to a sensor which detects gas composition of air exhaled by the patient. 
     Presence of nebulizer  220  is reported by nebulizer present sensor  207 . Presence of humidifier is reported by humidifier presence sensor  212 . Humidity of the air flow in humidifier branch inlet is detected by humidity sensor  208 . 
     Reference is now made to  FIG. 5  presenting heater  220  mounted within passage  10 . An airflow conducted by passage  10  from blower  20  to mouthpiece (not shown) can be heated, as needed. 
     Reference is now made to  FIGS. 6 a  to 6 d    presenting alternative embodiments of the present invention in terms of the minimal-dead-space conception. It should be mentioned that that in passage  10  there is air pressure directed to mouthpiece  50  while passage  40  ( 40   a ) provide a fluid communication with ambient atmosphere. 
     Specifically,  FIG. 6 a    shows inhalation passage  10  and exhalation passage  40   a.  No distance between terminals of passages  10  and  40   a  and mouthpiece  50 . Exhaled air is vented into ambient atmosphere. In other words, there is no dead space in the embodiment. Similar to  FIG. 6 a   , in  FIG. 6 b   , passage defined outer shell  40  serves an exhalation passage. 
     In  FIG. 6 c   , inhalation passage  10  is displaced inwardly passage (shell)  40 . Air within a space between edges of inhalation passage  10  and mouthpiece  50  after the exhalation phase is inhaled again. 
     An additional technical feature discriminating the embodiment of  FIG. 6 a    from two others is in arranging two passages  10  and  40   a  within mouthpiece  50  nearby in a parallel manner. Contrary to this,  FIGS. 6 b  and 6 c    present an arrangement where inhalation passage  10  is disposed in exhalation passage  40 . 
     Reference is now made to  FIGS. 7 a  to 7 d    presenting schematic diagrams of alternative embodiments of a nebulizer gate valve in closed and open positions. Specifically,  FIGS. 7 a  and 7 b    show a pneumatically openable valve. Numerals  300   a  and  300   b  refer to closed and open positions, respectively. A mechanically actuated valve in closed and open positions  310   a  and  310   b  is shown in  FIGS. 7 c  and 7 d   , respectively. 
     According to the present invention an inhaler is disclosed. The inhaler comprise: (a) a first passage having a first open end and a second open end; (b) a pressure source configured for generating an airflow; said pressure source connected to said first open end of said first passage; (c) a rotating shutter configured for blocking and releasing said airflow; (d) a mouthpiece being in fluid communication with second open end of said first passage; said mouthpiece configured for delivering a modulated airflow to a patient&#39;s airway. 
     It is a core feature of the invention to provide the inhaler comprising a second passage having first open end and a second open end. The first open end of said second passage is in fluid communication with said mouthpiece. The second open end of said second passage is vented to ambient air. The first and second passages are arranged such that said rotating shutter blocks and releases said first and second passages in an alternate manner. 
     According to one embodiment of the present invention, the first and second passages are arranged nearby in a parallel manner. 
     According to one embodiment of the present invention, the first passage is arranged within the second passage. 
     According to one embodiment of the present invention, the first passage has a passage gate valve configured for controlling a flow rate within said first passage. 
     According to another embodiment of the present invention, the first passage has a branch inlet configured for connecting a humidifier unit. 
     According to a further embodiment of the present invention, the nebulizer gate valve is selected from the group consisting of a mechanically actuated valve, an electrically actuated valve, a pneumatically actuated valve, a magnetically actuated valve and any combination thereof. 
     According to a further embodiment of the present invention, the nebulizer branch inlet comprises a cylinder reciprocatively displaceable within said nebulizer branch inlet between an open position at an inhalation phase and a closed position at an exhalation phase and. In said open position, said nebulizer is fluidly connected with said mouthpiece; said closed position blocks fluid communication between said nebulizer and said mouthpiece. 
     According to a further embodiment of the present invention, the nebulizer is connectable to an air pressure source. 
     According to a further embodiment of the present invention, a connection of said air pressure source to said nebulizer comprises an air pressure source gate valve. 
     According to a further embodiment of the present invention, the nebulizer is connectable to an oxygen source. 
     According to a further embodiment of the present invention, the inhaler comprises a control unit configured for controlling an element selected from the group consisting of said shutter, said passage gate valve, said humidifier gate valve, air pressure source gate valve, said airflow heater and any combination thereof; said control unit is preprogrammed for implementing a predetermined treatment protocol. 
     According to a further embodiment of the present invention, the inhaler comprises a sensor selected from the group consisting of a pressure sensor located at said first open end of said first passage and configured for detecting air pressure provided by said pressure source, a flow rate sensor located at said first open end of said first passage and configured to detect an airflow rate provided by said pressure sensor, a presence sensor located at said humidifier branch inlet and configured for detecting presence of said humidifier, a humidity sensor located at said humidifier branch inlet and configured for detecting air humidity provided by said humidifier, a barometric sensor configured to detect barometric pressure of ambient air, a an oxygen sensor located at said oxygen source, a presence sensor located at said nebulizer branch inlet and configured for detecting presence of said nebulizer, a pressure sensor located at said mouthpiece and configured for detecting air pressure within said mouthpiece, a lung gases sensor configured for detecting a gas composition of exhaled air, a humidity sensor located at said mouthpiece and configured for detecting air humidity within said mouthpiece, a temperature sensor located at said mouthpiece and configured for detecting temperature within said mouthpiece, an acoustic sensor located at said mouthpiece and configured for detecting breathing sounds within said patient&#39;s airway, an acoustic sensor located at a patient&#39;s body and configured for detecting breathing sounds within said patient&#39;s airway and any combination thereof. 
     According to a further embodiment of the present invention, a method of preventing and treating respiratory diseases is disclosed. The aforesaid method comprises steps of: (a) providing an inhaler further comprising (i) a first passage having a first open end and a second open end; (ii) a pressure source configured for generating an airflow; said pressure source connected to said first open end of said first passage; (iii) a rotating shutter configured for blocking and releasing said airflow; (iv) a mouthpiece being in fluid communication with second open end of said first passage; said mouthpiece configured for delivering a modulated airflow to a patient&#39;s airway; (v) said inhaler comprises a second passage having first open end and a second open end; said first open end of said second passage is in fluid communication with said mouthpiece; said second open end of said second passage is vented to ambient air; said first and second passages are arranged such that said rotating shutter blocks and releases said first and second passages in an alternate manner; (b) providing pneumatic pulses to said mouthpiece by means of blocking and releasing said airflow within said first passage; (c) venting said mouthpiece to ambient air. Steps b and c are executed in an alternate manner. 
     According to a further embodiment of the present invention, the step of providing pneumatic pulses comprises controlling a flow rate within said first passage by a passage gate valve configured for. 
     According to a further embodiment of the present invention, the step of providing pneumatic pulses comprises humidifying said airflow within said first passage by a humidifier connected to a branch inlet. 
     According to a further embodiment of the present invention, the step of humidifying said airflow comprises controlling a flow rate between said humidifier unit and said first passage by a humidifier gate valve. 
     According to a further embodiment of the present invention, the sub-step of humidifying said airflow comprises controlling a flow rate between said humidifier unit and said first passage by a humidifier gate valve. 
     According to a further embodiment of the present invention, the step of providing pneumatic pulses comprises a sub-step of nebulizing a medicament into said second passage. 
     According to a further embodiment of the present invention, the sub-step of nebulizing said medicament comprises positioning a reciprocatively displaceable cylinder within said nebulizer branch inlet into an open position at an inhalation phase and into a closed position at an exhalation phase such that said nebulizer is fluidly connected with said mouthpiece in said open position and a fluid communication between said nebulizer and said mouthpiece is blocked in said closed position. 
     According to a further embodiment of the present invention, the method comprises a step of a control unit configured for controlling an element selected from the group consisting of said electric motor, said passage gate valve, said humidifier gate valve and any combination thereof; said control unit is preprogrammed for implementing a predetermined treatment protocol. 
     According to a further embodiment of the present invention, the inhaler comprises a step of controlling said element feedback selected from the group consisting of said electric motor, said passage gate valve, said humidifier gate valve and any combination thereof comprises getting feedback from a pressure sensor.