Abstract:
A mouthpiece for a handheld inhaler is disclosed. A housing of the mouthpiece includes an inlet, an outlet opening, and a channel extending through the housing connecting the inlet and the outlet opening for directing an aerosol from the inlet to the outlet opening. An anterior portion of the housing ( 4 ) is configured for placement in the mouth of a patient. The anterior portion of the housing is configured to direct the outlet opening upwardly in the patient&#39;s oral cavity when in the mouth of the patient. Other embodiments include an outlet opening placed closer to the upper side of the housing than to the lower side of the housing. Further, an inhaler having a mouthpiece is disclosed

Description:
TECHNICAL FIELD 
       [0001]    Embodiments disclosed herein relate to mouthpieces for inhalers for inhaling a medicament in aerosol form. Other embodiments herein relate to inhalers for inhaling a medicament in aerosol form. 
       BACKGROUND 
       [0002]    Medicament administration via inhalation from a handheld inhaler is a well-known way of medicament administration to a patient. Some medicaments may be administered in powder form other medicament may be in liquid form which are administered as small droplets, both medicament forms may be referred to as aerosols. A patient puts a mouthpiece of the inhaler into his or her mouth and ejects a medicament dose, which is inhaled into the lungs of the patient. 
         [0003]    Naturally, it is desirable that as much as possible of the medicament dose reaches the lungs of the patient. If the mouthpiece is directed towards the tongue or the teeth of the patient, an unnecessary large part of the medicament dose remain in the mouth of the patient and will not reach the lungs of the patient. 
         [0004]    EP2381991 discloses an apparatus comprising a stepped mouthpiece for aerosol drug delivery. The apparatus aids in administering inhaled pharmaceutical aerosol to a patient. The apparatus is used in conjunction with an aerosol delivery device. The mouthpiece comprises steps on the top and bottom of the apparatus, which when used aid the patient in causing mandibular advancement, and opening of the mouth, also causing opening of the patient&#39;s airway, resulting in improved aerosol lung deposition. The steps are displaced horizontally in relation to each other when the mouthpiece is inserted into the mouth of a patient. The patient biting on the two steps causes the mandibular advancement. 
         [0005]    There is a need for alternative solutions, of administering a medicament in aerosol form to the lungs of a patient. 
       SUMMARY 
       [0006]    It is an object to provide a mouthpiece which improves the administering of a medicament in aerosol form to the lungs of a patient. 
         [0007]    According to an aspect, this object is achieved by a mouthpiece for use with a handheld inhaler, the mouthpiece comprising a housing, wherein the housing comprises: 
         [0008]    an inlet connectable to a medicament delivery device comprising a medicament container delivering an aerosol, 
         [0009]    an outlet opening for the aerosol, and 
         [0010]    a channel extending through the housing connecting the inlet and the outlet opening for directing the aerosol from the inlet to the outlet opening, wherein a plane extends through and along the channel, the plane defining on respective sides thereof an upper side and a lower side of the housing. An anterior portion of the housing is adapted to be placed in a mouth of a patient. The anterior portion of the housing is configured to direct the outlet opening upwardly in the oral cavity when the anterior portion is placed in the mouth of the patient. 
         [0011]    Since the outlet opening is upwardly directed in the mouth of the patient, an aerosol from the inhaler being ejected into the mouth of the patient from the outlet opening of the mouthpiece is directed along the tongue of the patient, rather than towards the tongue. The aerosol will thus largely avoid sticking to the tongue and instead follow the oral cavity to the pharynx, the tracheal and the lungs of the patent. As a result, the above mentioned object is achieved. 
         [0012]    It has been realized by the inventors that the mouthpiece as such may be configured to aid the patient in positioning the anterior portion in a mouth of a patient in a manner to improve the administering of an aerosol from an inhaler to the lungs of a patient. 
         [0013]    In use, when the mouthpiece forms part of an inhaler, the plane may be upwardly inclined when the anterior portion is inserted into the mouth of the patient. Some medicaments may be administered in powder form other medicament may be in liquid form which are administered as small droplets, approximately 1-9 μm in diameter. Herein both medicament forms will be referred to as aerosols. A patient puts the anterior portion of the mouthpiece of the inhaler into his, or her, mouth and ejects via the outlet opening a medicament dose, which is inhaled into the lungs of the patient. 
         [0014]    According to embodiments, the anterior portion of the housing may comprise a frusto-conical portion, the frusto-conical portion comprising a base extending substantially perpendicularly to the plane and a top extending substantially perpendicularly to the plane. The outlet opening may be arranged in the base, and the channel may extend through the top, between the inlet and the outlet opening. Accordingly, when placed in the mouth of the patient the wider base will be positioned farther into the oral cavity than the narrower top. Thus, a first portion of the outer surface of the frusto-conical portion may abut against the tongue, and a second portion of the outer surface may abut against the palate behind the front teeth. Due the nature of the frusto-conical shape and the outlet opening being arranged in the base, the outlet opening will be directed upwardly into the oral cavity of the patient when abutting against the tongue and the palate directing an aerosol into the middle of the oral cavity. The smaller size at the top than at the base will encourage a patient to place his, or her, lips around the top of the frusto-conical portion. Thus, it may be ensured that the outlet opening is positioned sufficiently far into a mouth of the patient. 
         [0015]    According to embodiments, the outlet opening may be smaller than the base of the frusto-conical portion, and the outlet opening may be centred in the base of the frusto-conical portion. In this manner, at the outlet opening, a distance may be created between the outlet opening and the tongue and a distance may be created between the outlet opening and the palate. Thus, the aerosol will be directed into the middle of the oral cavity. 
         [0016]    According to embodiments, the base of the frusto-conical portion may be oval. In this manner the anterior portion may be positioned centrally in the oral cavity, seen in a lateral direction. 
         [0017]    According to embodiments, an outer surface of the housing at the top of the frusto-conical portion may be provided with indentations and/or protrusions. In this manner a patient may sense the indentations and/or protrusions with his, or her, tongue, teeth, or lips to ensure that the entire anterior portion has been placed in the mouth of the patient. In particular, a patient may be instructed to sense the indentations and/or protrusions with the tip of his, or her, tongue. Thus, the tongue will be positioned out of the way of the outlet opening. Moreover, the mouthpiece will be angel away from the tongue. 
         [0018]    According to embodiments, groove portions adapted for placing lips of a patient there against may extend at least partially around the housing adjacent to the anterior portion. At least one groove portion on the upper side may extends closer to the outlet opening than at least one groove portion on the lower side. In this manner, when the patient places his or her lips in the groove portions on the upper side and on the lower side, the anterior portion will be placed in the mouth of the patient at an angle with the plane upwardly inclined to direct the outlet opening upwardly in the oral cavity. 
         [0019]    According to embodiments, the groove portions may comprise convexly curved bottom surfaces. In this manner the groove portions are adapted for placing the lips of the patient there against. 
         [0020]    According to a further aspect, the above mentioned object is achieved by a mouthpiece for use with a handheld inhaler, the mouthpiece comprising a housing, wherein the housing comprises: 
         [0021]    an inlet connectable to a medicament delivery device comprising a medicament container delivering an aerosol, 
         [0022]    an outlet opening for the aerosol, and 
         [0023]    a channel extending through the housing connecting the inlet and the outlet opening for directing the aerosol from the inlet to the outlet opening, wherein a plane extends through and along the channel, the plane defining on respective sides thereof an upper side of the housing and a lower side of the housing. An anterior portion of the housing is adapted to be placed in a mouth of a patient. The outlet opening is placed closer to the upper side of the housing than to the lower side of the housing. 
         [0024]    Since the outlet opening is placed closer to the upper side of the housing than to the lower side of the housing, an aerosol from the inhaler being directed into the mouth of the patient from the outlet opening of the mouthpiece is directed over the tongue of the patient, rather than towards the tongue. The aerosol will thus largely avoid sticking to the tongue and instead follow the oral cavity to the pharynx, the tracheal, and the lungs of the patient. As a result, the above mentioned object is achieved. 
         [0025]    Also this aspect follows the line of thought along which the inventors have realized that the mouthpiece as such may be configured to aid the patient in placing the anterior portion in a mouth of a patient in a manner to improve the administering of an aerosol from an inhaler to the lungs of a patient. 
         [0026]    According to embodiments, a channel-forming wall element of the channel may form at least a portion of an upper surface of the anterior portion on the upper side of the housing. A distance element positioned a distance from the channel may form at least a portion of a lower surface of the anterior portion on the lower side of the housing. In this manner the outlet opening may be placed closer to the upper side of the housing than to the lower side of the housing to create a distance between the tongue and the outlet opening. 
         [0027]    According to embodiments, the mouthpiece may comprise a front surface extending substantially perpendicularly to the plane, wherein the outlet opening is arranged in the front surface. 
         [0028]    According to a further aspect there is provided an inhaler comprising a mouthpiece according to any aspect or embodiment disclosed herein. The inhaler may be a handheld inhaler. 
         [0029]    Further features and advantages will become apparent when studying the appended claims and the following detailed description. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0030]    Various aspects of embodiments, including their particular features and advantages, will be readily understood from the example embodiments discussed in the following detailed description and the accompanying drawings, in which: 
           [0031]      FIGS. 1 a   - 4  illustrate various embodiments of mouthpieces for use with handheld inhalers, and 
           [0032]      FIGS. 5 and 6  illustrate handheld inhalers according to embodiments. 
       
    
    
     DETAILED DESCRIPTION 
       [0033]    Aspects of example embodiments will now be described more fully. Like numbers refer to like elements throughout. Well-known functions or constructions will not necessarily be described in detail for brevity and/or clarity. 
         [0034]      FIGS. 1 a  and 1 b    illustrate embodiments of a mouthpiece  2  for use with a handheld inhaler. The mouthpiece  2  forms a part of the inhaler, which is arranged to conduct an aerosol from a medicament container of the inhaler into an oral cavity of a patient. The mouthpiece  2  comprises a housing  4 . The housing  4  comprises an inlet  6  and an outlet opening  8 . The inlet  6  is connectable to a medicament delivery device of the inhaler comprising the medicament container delivering the aerosol. The mouthpiece  2  may for instance be connected to a body of an inhaler by means of a snap-fit connection, protrusions  9  of which are shown in  FIG. 1   b.  Through the outlet opening  8  the aerosol is adapted to be administered into the oral cavity to be inhaled into the lungs of the patient. A channel  10  extends through the housing  4  and connects the inlet  6  and the outlet opening  8 . Thus, the channel  10  is adapted to direct the aerosol from the inlet  6  to the outlet opening. A plane  12  extends through and along the channel  10 . The plane  12  defines on respective sides thereof an upper side  14  of the housing  4  and a lower side  16  of the housing  4 . The outlet opening  8  is arranged at a first end portion  17  of the housing  4 , between the upper side  14  and the lower side  16 . The inlet  6  is arranged at a second end portion  19  of the housing  4 , between the upper side  14  and the lower side  16 . When the mouthpiece  2  is positioned to be placed in the mouth of the patient, the upper side  14  is arranged to face substantially upwardly and the lower side  16  is arranged to face substantially downwardly. 
         [0035]    An anterior portion  18  of the housing  4  is adapted to be placed in the mouth of the patient. The anterior portion  18  of the housing  4  is configured to direct the outlet opening  8  upwardly in the oral cavity when the anterior portion  18  is placed in the mouth of the patient. 
         [0036]    In these embodiments, the anterior portion  18  of the housing  4  comprises a frusto-conical portion  20 . The frusto-conical portion  20  comprises a base  22  extending substantially perpendicularly to the plane  12  and a top  24  extending substantially perpendicularly to the plane  12 . The outlet opening  8  is arranged in the base  22 . The channel  10  extends through the top  24 , between the inlet  6  and the outlet opening  8 . 
         [0037]    Seen in a direction from the base  22  towards the top  24  along the plane  12 , a wide housing portion  28  is arranged adjacent to the top  24 . The anterior portion  18  thus, is terminated by the wide housing portion  28 . 
         [0038]    In a frusto-conical shape the base  22  is wider than the top  24 . When placed in the mouth of the patient, the wide base  22  of the frusto-conical portion  20  will be positioned farther into the oral cavity than the narrow top  24 . The patient places his or her lips around the top  24 . A first portion of an outer surface of the frusto-conical portion  20  on the lower side  16  of the housing  4  will abut against the tongue of the patient. A second portion of the outer surface of the frusto-conical portion  20  on the upper side  14  of the housing  4  may abut against the palate behind the front teeth of the patient. Thus, the natural shape of the mouth cavity and the tongue of the patient will position the frusto-conical portion  20  with the plane  12  upwardly inclined, e.g. at an angle of 30-60 degrees to a vertical axis in the mouth of the patient. Accordingly, the outlet opening  8 , being arranged in the base  22 , will be directed upwardly into the oral cavity of the patient. The aerosol from the medicament delivery device will thus be administered into a middle portion of the oral cavity between the tongue and the palate. Thus, minimising the aerosol deposition on the tongue and/or the palate, helping the aerosol to reach the lungs of the patient. 
         [0039]    The outlet opening  8  is smaller than the base  22  of the frusto-conical portion  20 . The outlet opening  8  is centred in the base  22  of the frusto-conical portion. The distances created between the tongue and the outlet opening  8  and the distance created between the palate and the outlet opening  8  by the outlet opening  8  being smaller than the base  22  also aids in administering the aerosol in the middle portion of the oral cavity. Thus, minimising the aerosol deposition on the tongue and/or the palate, helping the aerosol to reach the lungs of the patient. 
         [0040]    The base  22  of the frusto-conical portion  20  is oval. An outer surface of the housing  4  at the top  24  of the frusto-conical portion  20  is provided with indentations and/or protrusions  26 . A patient may sense the indentations and/or protrusions  26  with his or her tongue, teeth, or lips to ensure that the entire anterior portion  18  has been placed in the mouth. 
         [0041]    The following dimensions are mentioned purely as an example. The mouthpiece  2  may have a length of 10-70 mm. The length of the anterior portion  18  may be 10-40 mm. The large diameter of the base  22  may be 25-40 mm and the small diameter of the base  22  may be 15-25 mm. The large diameter of the top  24  may be 20-30 mm and the small diameter of the top  24  may be 12-20 mm. The diameter of the wide portion  28  may be 15-35 mm. The diameter of the outlet opening  8  may be 14-25 mm. 
         [0042]      FIGS. 2 a  and 2 b    illustrate embodiments of a mouthpiece  2  for use with a handheld inhaler. The mouthpiece  2  forms a part of the inhaler, which is arranged to conduct an aerosol from a medicament container of the inhaler into an oral cavity of a patient. Some features are common with the embodiments of  FIGS. 1 a    and  1   b.    
         [0043]    Thus again, the mouthpiece  2  comprises a housing  4 . The housing  4  comprises an inlet  6  and an outlet opening  8 . A channel  10  extends through the housing  4  and connects the inlet  6  and the outlet opening  8 . A plane  12  extends through and along the channel  10 . The plane  12  defines on respective sides thereof an upper side  14  and a lower side  16  of the housing  4 . When the mouthpiece  2  is positioned to be placed in the mouth of the patient, the upper side  14  is arranged to face substantially upwardly and the lower side  16  is arranged to face substantially downwardly. An anterior portion  18  of the housing  4  is adapted to be placed in the mouth of the patient. The anterior portion  18  of the housing  4  is configured to direct the outlet opening  8  upwardly in the oral cavity when the anterior portion is placed in the mouth of the patient. 
         [0044]    In these embodiments, groove portions  30 ,  32  extend at least partially around the housing  4  adjacent to the anterior portion  18 . The groove potions  30 ,  32  are adapted for placing lips of the patient there against. At least one groove portion  30  on the upper side  14  of the housing  4  extends closer to the outlet opening  8  than at least one groove portion  32  on the lower side  16  of the housing  4 . The groove portions  30 ,  32  comprise convexly curved bottom surfaces  33 . 
         [0045]    When the patient places his or her lips in the groove portions  30 ,  32  on the upper side  14  and on the lower side  16 , the anterior portion  18  will be placed in the mouth of the patient with the plane  12  upwardly inclined to direct the outlet opening  8  upwardly in the oral cavity. The plane  12  may be placed at an angle of 30-60 degrees with a vertical axis. The groove portions  30 ,  42  may extend across the plane  12  at an angle a of approximately 30-45 degrees. Thus, the anterior portion  18  is longer on the lower side  16  than on the upper side  14 . 
         [0046]    The following dimensions are mentioned purely as an example. The mouthpiece  2  may have a length of 20-50 mm. The length of the anterior portion  18  may be 10-20 mm at the upper side  14  and 20-40 mm at the lower side  16 . The diameter of the outlet opening  8  may be 14-24 mm. The radius of the convexly curved bottom surfaces  33  of the groove portions  30 ,  32  may be 5-10 mm. 
         [0047]      FIGS. 3 a  and 3 b    illustrate embodiments of a mouthpiece  2  for use with a handheld inhaler. The mouthpiece  2  forms a part of the inhaler, which is arranged to conduct an aerosol from a medicament container of the inhaler into an oral cavity of a patient. Some features are common with the embodiments of  FIGS. 1 a   - 2   b.    
         [0048]    Thus again, the mouthpiece  2  comprises a housing  4 . The housing  4  comprises an inlet  6  and an outlet opening  8 . A channel  10  extends through the housing  4  and connects the inlet  6  and the outlet opening  8 . A plane  12  extends through and along the channel  10 . The plane  12  defines on respective sides thereof an upper side  14  and a lower side  16  of the housing  4 . When the mouthpiece  2  is positioned to be placed in the mouth of the patient, the upper side  14  is arranged to face substantially upwardly and the lower side  16  is arranged to face substantially downwardly. An anterior portion  18  of the housing  4  is adapted to be placed in the mouth of the patient. 
         [0049]    In these embodiments, the outlet  8  opening is placed closer to the upper side  14  of the housing  4  than to the lower side  16  of the housing  4 . Thus, an aerosol from the inhaler being directed into the mouth of the patient from the outlet opening  8  of the mouthpiece  2  is directed over the tongue into the oral cavity to improve the administering of the aerosol from the inhaler to the lungs of the patient. 
         [0050]    A channel-forming wall element  34  of the channel  10  forms at least a portion of an upper surface  36  of the anterior portion  18  on the upper side  14  of the housing  4 . A distance element  38  is positioned at a distance from the channel  10  and forms at least a portion of a lower surface  40  of the anterior portion  18  on the lower side  16  of the housing  4 . Accordingly, the outlet opening  8  is placed closer to the upper side  14  of the housing  4  than to the lower side  16  of the housing  4  to create a distance between the tongue of the patient and the outlet opening  8 . 
         [0051]    The distance element  38  extends outside the outlet opening  8  seen along the plane  12 . The distance element  38  connects to the channel-forming wall element  34  at a middle portion of the channel  10 . 
         [0052]    The following dimensions are mentioned purely as an example. The mouthpiece  2  may have a length of 10-70 mm. The length of the anterior portion  18  may be 10-40 mm. The diameter of the outlet opening  8  may be 14-24 mm. The distance between the centre of the channel  10 , i.e. the plane  12 , to the lower surface  40  may be 10-20 mm. 
         [0053]      FIG. 4  illustrates embodiments of a mouthpiece  2  for use with a handheld inhaler. The mouthpiece  2  forms a part of the inhaler, which is arranged to conduct an aerosol from a medicament container of the inhaler into an oral cavity of a patient. The mouthpiece  2  according to these embodiments is similar to the mouthpiece according to the embodiments of  FIGS. 3 a -3 b   . The main difference lies in that the distance element  38  is shaped differently to create an oval shaped end of the anterior portion  18  at the outlet opening  8 . The distance element  38  does not extend beyond the outlet opening  8 . However again, the distance element  38  is positioned a distance from the channel  10  and forms at least a portion of a lower surface  40  of the anterior portion  18  on the lower side  16  of the housing  4 . 
         [0054]      FIG. 5  illustrates a handheld inhaler  50  according to embodiments. The inhaler  50  comprises a mouthpiece  2 , an inhaler body  52 , and a medicament container holder  54 . The inhaler body  52  and the medicament container holder  54  may form a medicament delivery device. A patient uses the inhaler  50  by placing an anterior portion  18  of the mouthpiece  2  into his or her mouth, and pressing the medicament container holder  54  towards the inhaler body  52  while inhaling to eject a dose of medicament in aerosol form to be administered via the mouthpiece  2  into the mouth and the lungs of the patient. 
         [0055]    The mouthpiece  2  according to these embodiments is similar to the mouthpiece according to the embodiments of  FIGS. 3 a , 3 b   , and  4 . The main difference lies in that the mouthpiece  2  comprises a front surface  56  extending substantially perpendicularly to the plane  12 . The outlet opening  8  is arranged in the front surface  56 . Again, a distance element  38  is positioned at a distance from the channel  10  forming at least a portion of a lower surface  40  of the anterior portion  18  on the lower side  16  of the housing  4  of the mouthpiece  2 . 
         [0056]      FIG. 6  illustrates a handheld inhaler  50  according to embodiments. The inhaler  50  comprises a mouthpiece  2 , an inhaler body  52 , inside which a medicament container is arranged, and an energy supplying arrangement  60 . The inhaler body  52  and the energy supplying arrangement  60  may form a medicament delivery device. The energy supplying arrangement  60  is loaded by a patient prior to administering an aerosol from the inhaler  50 . The patient places an anterior portion  18  of the mouthpiece  2  into his or her mouth, and releases the energy supplying arrangement  60  by pressing the release button  62 . At the same time the patient inhales. Thus, a dose of medicament in aerosol form is ejected from the medicament container by the energy supplying arrangement  60  and administered via the mouthpiece  2  into the mouth and the lungs of the patient. The energy supplying arrangement  60  may be reusable. The inhaler body  52  and the mouthpiece  2  may be disposable. 
         [0057]    The mouthpiece  2  illustrated in  FIG. 6  corresponds to the embodiments illustrated in  FIGS. 1 a    and  1   b.  Mouthpieces  2  according to other embodiments disclosed herein may alternatively be used. 
         [0058]    Similarly, mouthpieces  2  according to embodiments disclosed in  FIGS. 1 a   - 4  may alternatively be used in the inhaler  50  according to the embodiments disclosed in  FIG. 5 . 
         [0059]    This invention should not be construed as limited to the embodiments set forth herein. A person skilled in the art will realize that different features of the described embodiments may be combined to create embodiments other than those described herein, without departing from the scope of protection, as defined by the appended claims. The mouthpieces  2  disclosed herein may be manufactured from plastic material, such as polymers. Although the invention has been described with reference to example embodiments, many different alterations, modifications and the like will become apparent for those skilled in the art. Therefore, it is to be understood that the foregoing is illustrative of various example embodiments and that the invention is defined only the appended claims. 
         [0060]    As used herein, the term “comprising” or “comprises” is open-ended, and includes one or more stated features, elements, steps, components or functions but does not preclude the presence or addition of one or more other features, elements, steps, components, functions or groups thereof.