Patent Publication Number: US-11389602-B2

Title: Nebulization device for medical mixture

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
     This application is a national phase of PCT/EP2018/069492, filed Jul. 18, 2018, and claims priority to Italian Patent Application No. 102017000082273, filed Jul. 19, 2017, the entire contents of both of which are hereby incorporated by reference. 
     FIELD OF APPLICATION 
     The present invention relates to a portable nebulization device for medical fluids, and in particular to a universal nebulization device, optimized for the treatment of all of the tracts of a patient&#39;s respiratory system. 
     The above nebulization apparatus finds useful application in the medical field, particularly in the aerosol therapy field. 
     PRIOR ART 
     The administration of drugs by air tract through appropriate nebulizing devices is a therapeutic practice usually employed in relation to numerous diseases, especially of the respiratory apparatus. 
     In particular, nebulization allows dividing a drug in the liquid form into a plurality of very fine particles, having a diameter of a few micrometers, which can be easily inhaled by a patient. 
     It is also known that for the treatment of the various tracts of the respiratory system a specific nebulization is necessary. 
     Indeed, in order for the nebulized particles to be able to reach differently the upper respiratory tract, the tracheo-bronchial tract or the pulmonary alveoli a different sizing is needed. 
     In fact, for a treatment involving the first respiratory tract a coarser nebulization is recommended, whereas for the deeper respiratory tracts a very fine nebulization is essential. 
     The optimal granulometry for the treatment of the specific respiratory tracts is indicated in the bibliography and in the specific UNI EN 13544-1 standard, which specifies that:
         a diameter greater than 5 μm allows a deposition in the upper respiratory tract;   a diameter comprised between 2 μm and 6 μm allows a deposition in the tracheo-bronchial tract;   a diameter comprised between 0.5 μm and 3 μm allows a deposition at the level of the pulmonary alveoli.       

     In order to obtain a granulometry suitable for the various needs above listed, the most adopted solution has been that of using specific components for each purpose. 
     In particular, within a known configuration of a nebulization device, more atomizers have been provided, from which pressurized gas is introduced (also called “pisper”). 
     According to the adopted atomizer, there is indeed a more or less fine nebulization of the medical liquid. 
     This type of solution allows obtaining the undoubted advantage of providing precise dimensional atomization values for all needs. 
     However, it is equally clear that this solution also implies the drawback of being more difficult to be used. 
     In fact, it is necessary for the patient to have a minimum competence in choosing the correct atomizer in own specific case. This clearly involves the inherent risk of an incorrect choice of the atomizer. 
     To this drawback those of lack of practicality due to the need for replacement and to keep a greater quantity of components of the nebulization device with the risk of loss when not used are added. 
     For this reason, devices allowing a geometric positioning variation of the same components to obtain a different nebulization have also been provided. 
     For instance, European patent application no. EP 2 952 219 A1 to 3A Health Care S.r.l. provides for a displacement of the air intake duct within the nebulization device, in order to vary the relative position thereof with respect to the atomizer from which pressurized gas is introduced. 
     Although this solution allows an advantage for the different nebulization obtained based on the relative position between the two above mentioned components, it also has drawbacks from an operation point of view. 
     In fact, due to the structural complexity, it does not allow a correct disassembling among the nebulization device components and a consequent inadequate cleaning/disinfection/sterilization. 
     In fact, we wish torecall that, since the nebulization devices are used for patients suffering from lung infections, all the components adopted must ensure a certain level of sterilization, so as not to further worsen said infection. 
     Another known technical solution is disclosed in U.S. Pat. No. 3,658,059 A, which relates to an inhaler provided with a diaphragm to change the effective size of the passage suitable for making the suspension to be inhaled pass. The diaphragm is moved towards and away from the inhaler jet, in order to increase or reduce the opening. Though advantageous under various aspects, this solution does not allow a simple disassembling of the components to favour the cleaning and sterilization thereof. 
     A further known solution is described in European patent application no. EP 3 017 839 A1, which relates to a device for aerosol nebulizing substances with a separation element configured to divide the nebulization chamber into at least two sectors and with means for moving the separation element and adjusting the flow rate exiting from the device. This solution as well is not effective from the point of view of simplicity and ease of use in adjusting the nebulization level of the medicament by the user. 
     An object of the present invention is to provide a nebulization device that allows obtaining a different granulometry of the particles according to the needs of the specific patient, without replacing the components. 
     A further object is to provide the total disassembling of the nebulization device to allow the correct cleaning/disinfection/sterilization of the adopted components. 
     Another object is to provide a nebulization device of practical use, even by not particularly experienced patients. 
     Finally, a further object is to provide a nebulization device that is structurally simple so as to avoid constructive problems which are not suitable for a product intended for mass production. 
     SUMMARY OF THE INVENTION 
     The solution idea underlying the present invention is to provide a nebulization device that allows the intake of air from outside in different quantities according to the needed granulometry to obtain. 
     The above technical problem is solved by a nebulization device for medical mixture, of the type comprising a containing ampoule for the medical mixture, at least one atomizer for the intake of pressurized gas within said ampoule, at least one emission opening of said nebulized medical mixture and at least one window for the intake of air from outside. The atomizer is surmounted by an upper portion of the ampoule. At least one, preferably two selection side windows are further provided on the wall of the upper portion of the ampoule, whose opening is shielded by shielding means. Said shielding means are moved, precisely allowing the shielding, by a command shaft thereto connected and by a shielding selector coupled and linked to a control knob connected to said command shaft; the coupling between said control shaft and said shielding selector being obtained by a threaded coupling. 
     According to a preferred embodiment, the shielding means are comprised in a skirt-shaped shielding selector which the shaft is connected to. 
     Furthermore, according to a preferred embodiment, the command shaft extends along the central axis of the duct. 
     According to another aspect of the invention, the shielding means consist in at least two bulkheads which extend parallel to the command shaft at the selection side windows. 
     According to another aspect of the invention, the nebulization device further comprises a control knob at an end of the command shaft in order to vary the position along the axis of the shaft itself through a rotary-translational movement. 
     According to a further aspect of the invention, the rotary-translational movement of said control knob that moves the command shaft is obtained through a cam groove obtained on an inner wall of the ampoule within which the control knob moves. 
     Alternatively, according to another embodiment of the invention, a wide-radius external thread is provided on the outer surface of the command shaft, external thread that engages with a corresponding inner thread of a threaded portion of the shielding selector. 
     According to a second embodiment of the present invention, the shielding selector comprises two additional entry windows for the intake of air within said ampoule. 
     According to a further aspect of the invention, the nebulization device further comprises at least two valves at a base of said control knob for the variation of air flow into the inhalation and exhalation phases. 
     Still according to another aspect of the present invention, the nebulization device provides a mouthpiece at the emission outlet for the connection with the patient&#39;s air tracts. 
     Furthermore, according to an aspect of the invention, the ampoule is made of two pieces interconnected to each other. 
     Further features and advantages will become clearer from the following detailed description of a preferred, but not exclusive, embodiment of the present invention, with reference to the appended figures given by way of non-limiting example. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       In said drawings: 
         FIG. 1  represents an exploded view of an embodiment of the nebulization device according to the invention; 
         FIGS. 2 a , 2 b  and 2 c    represent sectional views of the three operating positions of the nebulization device of  FIG. 1 ; 
         FIGS. 3 a , 3 b , 3 c  and 3 d    represent sectional views of the valve system and of the nozzle of the nebulization device of  FIG. 1 ; 
         FIG. 4  represents an exploded view of a second embodiment of the nebulization device according to the invention; 
         FIGS. 5 a , 5 b  and 5 c    represent sectional views of the three operating positions of the nebulization device of  FIG. 4 ; 
         FIGS. 6 a , 6 b , 6 c  and 6 d    represent sectional views of the valve system and of the nozzle of the nebulization device of  FIG. 1 ; 
         FIGS. 7 a  and 7 b    show the sectional views of a third embodiment of a nebulization device according to the invention; 
         FIGS. 8 a , 8 b  and 8 c    show an exploded view of a fourth embodiment of a nebulization device according to the invention; 
         FIGS. 9 a , 9 b    show an exploded view of a variant of the embodiment of  FIGS. 8 a , 8 b    and  8   c.    
     
    
    
     DETAILED DESCRIPTION 
     With reference to the figures, and particularly to  FIG. 1 , reference number  1  globally and schematically indicates a nebulization device realized according to the present invention. 
     Said nebulization device  1  is illustrated in the Figures arranged vertically, according to a preferred operating configuration. In the following of the present invention, the positions and orientations, relative and absolute, of the various elements which the device is made of, defined by means of terms such as upper and lower, on and under, horizontal and vertical or other equivalent terms, will be expressed with reference to said configuration without them representing a limitation of the Applicant&#39;s rights. 
     The nebulization device  1  comprises an ampoule  2 , preferably divided into two components, an upper component  2   a  and a lower component  2   b , respectively. 
     The upper component  2   a  is preferably shaped as a circular section with an upper portion  3 , having a larger diameter, and a lower portion  4 , having a smaller diameter, which are connected to each other by a truncated-conical portion  5 . 
     The lower component  2   b  preferably is also shaped as a circular section. Said lower component  2   b  preferably has an ergonomic profile externally, which facilitates the grip by the patient during the therapy. The lower component  2   b  further has an open end  6  within which the coupling with the upper component  2   a  occurs. 
     Preferably, at a side surface  10  of the component  2   b , there is an opening  11  from which a duct segment  12  departs, which is preferably inclined by an angle with respect to a cross-section of the lower component  2   b.    
     The duct segment  12  is shaped so as to couple to a connection device with the patient&#39;s air tracts, such as, for instance, a mouthpiece  13 . 
     Nothing forbids adopting other connection devices with the patient&#39;s air tracts, such as the known nasal masks or forks. 
     At an end  7  opposite the open end  6 , there is a closing surface  8 , which is glass-shaped and comprising a nozzle-duct  9 . 
     On the nozzle-duct  9  an atomizer  14  (also known in the art with the name of “pisper”) is fitted. 
     Said atomizer  14  is surmounted by the lower portion  4  of the upper component  2   a.    
     Between such a lower portion  4  and the atomizer  14  a shielding selector  15 , which is preferably skirt-shaped, comprising at least one, preferably two, shielding means  16 , is interposed. Said shielding means preferably consist in two bulkheads that develop parallel according to the longitudinal development of the ampoule  2 . Furthermore, said shielding means  16  are preferably circumference-arc shaped. 
     Differently from the prior art, the invention does not provide any movement of the duct for the intake of air within the nebulization device to vary the relative position thereof with respect to the atomizer from which the intake of pressurized gas occurs, but just a relative movement of the shielding means  16  with respect to the atomizer  14 . 
     The shielding means  16 , according to the position along the axis, can control the flow coming from the atomizer  14 . The shielding selector  15  is connected at an end  32  of the command shaft  17  which controls the movement thereof. 
     The command shaft  17 , preferably provided along the longitudinal transversal axis of the ampoule  2 , slides longitudinally, precisely moving the shielding selector  15 . 
     At the opposite end  33  of the command shaft  17  and connected thereto a control knob  18  is preferably provided. 
     It is possible to provide for the control knob  18  to be integrally formed with the command shaft  17 . 
     The shielding selector  15  is coupled and linked to the control knob  18  connected to said command shaft  17 ; the coupling between said command shaft  17  and said shielding selector  15  being obtained by a threaded coupling; for instance, a worm screw coupling. 
     The control knob  18  has a circular section, with a gripping portion  29  along a diameter thereof, ergonomically shaped to facilitate the rotation of the control knob  18 . 
     The control knob  18 , at the sides of the gripping portion  29 , is crossed by at least one, preferably two entry windows  19 , through which there is the intake of external air within the ampoule  2 . 
     The control knob  18  provides a cam groove  21  on the outer surface  20 . 
     The cam groove  21  is engaged by corresponding engaging pins  22  arranged at an inner surface  23  of the upper portion  3  of the upper component  2   a.    
     At the lower portion  4  of the upper component  2   a , at least one, preferably two, selection side windows  24  are obtained. Below said selection side windows  24  there is a lower portion sector  4  having height H. The two windows  24  are preferably provided on diametrically opposite parts. 
     Said selection side windows  24  can be totally, partially or not at all obstructed by the shielding means  16 , as it can be seen in  FIGS. 2 a , 2 b  and 2 c   , respectively. 
     Immediately contiguous to the control knob  18 , at the entry windows  19 , a valve system  25  is provided. 
     The valve system can be more evident in  FIGS. 3 a , 3 b    and  3   c.    
     The valve system  25  works synergistically with a valve  26  present on the mouthpiece  13 . 
     In particular, in  FIGS. 3 b  and 3 c    respectively, the closing and opening conditions of the valve system  25  are represented. 
     The valve system  25  of the present embodiment comprises two valves which open in the inhalation phase. In this phase, on the contrary, the closing of the valve  26  arranged on the mouthpiece  13  occurs. Vice versa, in the exhalation phase the closing of the valves of the valve system  25  and the opening of the valve  26  on the mouthpiece  13  occur. 
     Instead, in  FIG. 3 d    an enlarged section of the functional coupling between the nozzle duct  9 , the atomizer  14  and the shielding selector  15  is highlighted. 
     In  FIG. 4  a second embodiment of the present invention is represented. 
     Said embodiment differs from the embodiment represented in  FIG. 1  in the presence of two additional entry windows  27  on the shielding selector  15 , close to the coupling with the command shaft  17 . 
     Another difference of this embodiment with respect to the embodiment of  FIG. 1  is represented by the absence of the truncated-conical portion  5  between the upper portion  3  and the lower portion  4  of the upper component  2   a  of the ampoule  2 . Instead of this truncated-conical portion  5 , an immediate reduction in section between the upper portion  3  and the lower portion  4  is provided at a cross-section  28 . 
     The lower portion  4  of the upper component  2   a  of the ampoule  2  is therefore longer with respect to the first embodiment of the invention. 
     A further difference of this embodiment with respect to the one represented in  FIG. 1  is represented by the valve system  25 . In fact, instead of the two valves of the first embodiment, a unique baffle  30  is provided. 
     It is possible to see in detail the different valve system of the second embodiment in  FIGS. 6 a , 6 b    and  6   c.    
     The baffle  30  operates analogously to the valves of the first embodiment. In fact, a deformation thereof inwards allows the air flow in the inhalation phase, when the corresponding valve  26  on the mouthpiece  13  is closed. Instead, in the exhalation phase the baffle  30  returns to a rectilinear conformation, thus occluding the entry windows  19 , whereas the opening of the valve  26  occurs on the mouthpiece  13 . 
     Instead, in  FIG. 6 d    an enlarged section of the functional coupling between the nozzle duct  9 , the atomizer  14  and the shielding selector  15  is highlighted. 
     Since the valve system  25  is particularly complex and, consequently expensive, a third embodiment represented in  FIGS. 7 a  and 7 b    is provided. 
     In said Figures it can be noticed that the valve system is replaced by a virtual valve system  37 . Said virtual valve system  37  is obtained through a different conformation of the entry windows  19 . In fact, instead of housing valves, such entry windows  19  have a “wolf-mouth” section, which is sufficient to ensure the correct delivery of the nebulized and meanwhile to properly obstruct the discharge of the flow exhaled by the patient. In this way said exhaled flow is free to vent through the side windows of the mouthpiece, which is also devoid of a valve. 
     A fourth embodiment is also provided, which is realized as an alternative adjustment mode through the shielding selector  15 . 
     According to said embodiment, the shielding selector  15  is provided with a threaded portion  34  protruding upwards, which is provided with an inner thread  35 , which is at least a single-start-thread. 
     Said inner thread  35  is engaged by at least one wide-radius external thread  36  obtained on an external surface  38  of the command shaft  17 . 
     As a result, the above-mentioned adjustment of the shielding selector  15  is obtained through a rotary movement of the command shaft  17  within the threaded portion  34  of the shielding selector  15  itself. 
     Therefore, engaging pins  22  sliding in a cam groove  21  of the control knob  18  are not provided. 
     Said solution allows reducing the size in height both of the control knob  18  and of the upper part  2   a , thus making the ampoule  2  more compact. 
     Nothing forbids using a threaded coupling with a multiple-start thread  36  as represented in  FIGS. 9 a , 9 b    instead of a wide-radius external thread  36  with an almost similar operation. 
     In said Figures a lower portion sector  4 ′ is further shown, below the selection side windows  24 , having height H 1 , which is greater than the dimension H present in the described embodiments. Said dimension variation allows both strengthening such a sector and obtaining a better selection of the size of the particles, which can have more reduced size. 
     Furthermore, the protuberance  39  houses locking wings adapted to block the rotation of the command shaft  17  within the threaded portion  34  of the shielding selector  15  once the desired shielding position has been reached. 
     In the following the operation of the nebulization device  1  according to the invention will be described, considering, for illustrative purpose, the above described embodiments. 
     In particular, reference is made to  FIGS. 2 a , 2 b  and 2 c    for the first embodiment and to  FIGS. 5 a , 5 b  and 5 c    for the second embodiment. 
     Once the ampoule  2  of the nebulization device  1  has been filled in with medical fluid and assembled, the operation of the components also present in the prior art does not result to be varied. 
     Therefore, the intake of pressurized gas through the nozzle duct  9  and the atomizer  14  occurs. 
     Simultaneously, through the entry windows  19  the intake of external air within the ampoule  2  occurs. 
     Therefore, the nebulization of the medical fluid occurs, which is inhaled by the patient through the mouthpiece  13  connected to the emission duct  12 . 
     According to the invention, through the command shaft  17 , the shielding selector  15  and the selection side windows  24  the required granulometry can be obtained. 
     Through the rotation of the control knob  18  and the consequent sliding of the engaging pins  22  within the cam groove  21 , there occurs a rotary-translational movement of the control knob and jointly of the command shaft  17 . 
     Thus, the movement of the shielding selector  15  and of the shielding means  16  is thus allowed. 
     As seen, the present embodiments provide three selection positions, to each of which the correct granulometry for the respiratory tract affected by the specific patient&#39;s therapy corresponds. 
     This does not exclude that it is possible to provide a greater number of positions to specify even more a tract to which a therapy can be addressed, without departing from the object of the present invention defined by the appended claims. 
     The three illustrated selection positions correspond, in this case, to:
         position  1 , as illustrated in  FIGS. 2 a , 5 a   : a total opening of the selection side windows  24  by the shielding means  16  of the shielding selector  15 ;   position  2 , as illustrated in  FIGS. 2 b , 5 b   : a partial opening of the selection side windows  24  by the shielding means  16  of the shielding selector  15 ;   position  3 , as illustrated in  FIGS. 2 c , 5 c   : a total occlusion of the selection side windows  24  by the shielding means  16  of the shielding selector  15 .       

     In this way, there are obtained, respectively:
         large particles for the treatment of the upper respiratory tracts;   particles suitable for the tracheo-bronchial tract treatment;   fine particles for the treatment of pulmonary alveoli.       

     In particular, experiments performed by the Applicant have shown that the ampoule  2 , according to the configuration, allows obtaining a dimensional difference of MMAD (Mass Median Aerodynamic Diameter) of the particles which varies:
         by about 30-50% between position  1  and position  2 , and   by about 150-200% between position  1  and position  3 .       

     Surely, the delivery speeds also differ markedly, indicatively by the same variation value cited for the dimensions of the particles. 
     Using the second embodiment illustrated in  FIG. 4  and previously described, through the use of the additional entry windows  27  on the shielding selector  15 , the flow area for the air entering the ampoule  2  is varied. 
     Clearly, the greater or smaller dimension of the flow area and therefore the greater or lesser consistency of the air flow affects both the delivery speed and the size of the aerosol particles generated by the ampoule  2 . 
     Furthermore, in the second embodiment illustrated in  FIG. 4 , the replacement of the truncated-conical portion  5  instead of a sharp reduction in diameter between the upper portion  3  and the lower portion  4  of the upper component  2   a  may also affect the performance of the ampoule  2 . 
     Advantageously, the described nebulization device allows the formation of a medical aerosol having different granulometries. In this way the nebulization device  1  according to the invention allows being universally optimized for all the required therapies, whether they are directed to the upper respiratory tracts, to the tracheo-bronchial tract, or more internally to the pulmonary alveoli. 
     Further advantageously, this can be simply obtained by rotating a control knob  18  by a predetermined quantity, thus reaching the correct level of shielding of the flow exiting from the atomizer  14 . 
     Furthermore, advantageously, the nebulization device  1  is completely disassemblable. Therefore, the practicality of the cleaning, disinfection and sterilization phases of the nebulization device  1  components is improved. In fact, with respect to the prior art, embedded, hidden or difficult to reach components are not present, as above described. In this way the hygiene required for a medical device and the prevention of the proliferation of germs, bacteria and viruses are ensured. 
     Still advantageously, the disassemblability feature is inherently connected to the substitutability feature. It is in fact possible, in case of malfunction or damage to one of the components, to only replace the malfunctioning or damaged component. 
     A skilled person will also understand how the nebulization device  1  according to the invention is practical to use by any patient, without the possibility to incur errors which could make the therapy ineffective. 
     Still advantageously, the components of the nebulization device  1  are made of materials suitable for the purpose, both in terms of nebulization and in terms of strength, easy availability and lastly, they are not overly expensive. 
     The skilled person will understand that the embodiment described can be subjected to various changes and variations, according to specific and contingent needs, all included within the scope of protection of the invention, as defined by the following claims.