Method and apparatus comprising stepped mouthpiece for aerosol drug delivery

An apparatus to aid aerosol delivery to a user comprising:

• a body, the body having a first side and a second side opposite the first side, the body having a medicament outlet end, a longitudinal axis and a distal end opposite the medicament outlet end, the body comprising a bore through the apparatus from the distal end to the medicament outlet end along a longitudinal axis to facilitate breathing by the user while the apparatus is held within a mouth of the user in an as-used position of the apparatus;
• a first stop on the first side of the apparatus, the first stop being disposed distally of the medicament outlet end and having a facial-facing surface forming a vertical plane bisecting the device, configured to face in a patient distal-to-proximal direction when in use and perpendicular to the longitudinal axis of the body and configured to engage a facial surface of one or more maxillary incisors of the user and a second stop on a second side of the apparatus, the second side being opposite the first side, forming a second vertical plane bisecting the device, configured to face in a patient proximal-to-distal direction when in use, the second stop being disposed distally of the medicament outlet end and configured to engage a lingual surface of one or more mandibular incisors of the user in the as-used position of the apparatus, wherein the relative position of the first stop and the second stop is such that upon insertion of the body into the user's mouth in the as-used position of the apparatus, a lower mandible of the user is advanced toward the distal end and relative to the one or more maxillary incisors along the longitudinal axis of the body.

A mouthpiece comprising:

• a body, the body having a first side and a second side opposite the first side, the body having a medicament outlet end, a longitudinal axis and a distal end opposite the medicament outlet end, the body forming a tubular flow path therethrough along a longitudinal axis to facilitate breathing by a user while the mouthpiece is installed within a mouth of the user comprising an as-used position of the mouthpiece;
• a first stop disposed on the first side, the first stop being disposed distally of the medicament outlet end and having a facial-facing surface forming a vertical plane bisecting the device, configured to face in a patient distal-to-proximal direction when in use and perpendicular to a longitudinal axis of the body and configured to engage a facial surface of one or more maxillary incisors of the user in the as-used position;
• a second stop disposed on the second side, the second stop being disposed distally of the medicament outlet end and having a lingual-facing surface forming a second vertical plane bisecting the device, configured to face in a patient proximal-to-distal direction when in use and perpendicular to the longitudinal axis of the body and configured to engage a lingual surface of one or more mandibular incisors of the user when the mouthpiece is in the as-used position,
• wherein the relative positions of the first stop and the second stop are offset along the longitudinal axis of the mouthpiece and are positioned such that the first stop is nearer to the medicament outlet end than the second stop to advance a lower mandible of the user toward the distal end and relative to the one or more maxillary incisors along the longitudinal axis of the mouthpiece when the mouthpiece is in the as-used position.

A method of aiding aerosol delivery to a user, the method comprising;

• advancing a lower mandible of the user with a mandibular advancement apparatus, the mandibular advancement apparatus comprising a body, the body having a first side and a second side opposite the first side, the body having a medicament outlet end, a longitudinal axis a distal end opposite the medicament outlet end, the body having a first stop disposed distally of the medicament outlet end and having a facial-facing surface forming a vertical plane bisecting the device, configured to face in a patient distal-to-proximal direction when in use and perpendicular to the longitudinal axis of the body and configured to engage a facial surface of one or more maxillary incisors of the user and a second stop disposed distally of the medicament outlet end and having a lingual-facing surface forming a second vertical plane bisecting the device, configured to face in a patient proximal-to-distal direction when in use and perpendicular to the longitudinal axis of the body and configured to engage a lingual surface of one or more mandibular incisors of the user, the advancing of the lower mandible being toward the distal end along a longitudinal axis of the mandibular advancement apparatus such that the lingual surface of the one or more mandibular incisors is advanced along the longitudinal axis relative to the facial surface of the one or more maxillary incisors.

An inhaled pharmaceutical aerosol delivery device comprising a mouthpiece, wherein the mouthpiece comprises:

• an inlet;
• a first stop disposed on a first side;
• a second stop disposed on a second side opposite the first side;
• a medicament-outlet end opposite the inlet;
• a longitudinal axis, the inlet and medicament outlet end connected by a tubular passageway extending therebetween;
• wherein:
• the first stop is disposed along a longitudinal axis of the device distally of the medicament outlet end and nearer to the medicament outlet end than the second stop, a first stop having a facial-facing surface forming a vertical plane bisecting the device, configured to face in a patient distal-to-proximal direction when in use and perpendicular to the longitudinal axis of the body and being configured to engage a facial surface of one or more maxillary incisors of the user in an as-used position of the device installed in a mouth of a user;
• the second stop is disposed on the second side along the longitudinal axis of the device distally of the medicament outlet end and nearer to the inlet than the first stop, the second stop having a lingual-facing surface forming a second vertical plane bisecting the device, configured to face in a patient proximal-to-distal direction when in use and perpendicular to the longitudinal axis of the body and being configured to engage a lingual surface of one or more mandibular incisors of the user when the mouthpiece is in the as-used position;
• wherein the relative positions of the first stop and the second stop are configured to advance a lower mandible of a user away from the medicament outlet end and relative to the one or more maxillary incisors along the longitudinal axis of the device when the mouthpiece is installed in the mouth of the user in the as-used position.

A metered dose inhaler comprising a mouthpiece, wherein the mouthpiece comprises:

• an inlet;
• a first stop on a first side;
• a second stop on a second side opposite the first side;
• a medicament-outlet end opposite the inlet;
• a longitudinal axis, the inlet and medicament outlet end connected by a tubular passageway extending therebetween;
• and
• wherein:
• the first stop is disposed on the first side to face toward the medicament outlet end and on an inlet side of the medicament outlet end;
• the second stop is disposed on the second side to face away from the medicament outlet end and on an inlet side of the medicament outlet end;
• the first stop having a facial-facing surface forming a vertical plane bisecting the device, configured to face in a patient distal-to-proximal direction when in use and perpendicular to the longitudinal axis of the body and being configured to engage a facial surface of one or more maxillary incisors of a user in an as-used position of the mouthpiece installed within a mouth of the user;
• the second stop having a lingual-facing surface forming a second vertical plane bisecting the device, configured to face in a patient proximal-to-distal direction when in use and perpendicular to the longitudinal axis of the body and being configured to engage a lingual surface of one or more mandibular incisors of the user in the as-used position;
• and
• the facial-facing surface of the first stop is disposed nearer to the medicament outlet end of the mouthpiece than the lingual-facing surface of the second stop, such that a lower mandible of the user is advanced away from the medicament outlet end and relative to the one or more maxillary incisors along a longitudinal axis of the mouthpiece when the mouthpiece is in the as-used position.

A metered dose inhaler actuator comprising a mouthpiece, wherein the mouthpiece comprises:

• an inlet;
• a first stop on a first side;
• a second stop on a second side, the second side being opposite the first side;
• a medicament-outlet end opposite the inlet;
• a longitudinal axis, the inlet and medicament outlet end connected by a tubular passageway extending therebetween;
• and
• wherein:
• the first stop is disposed on the first side to face toward the medicament outlet end and on an inlet side of the medicament outlet end;
• the second stop is disposed on the second side to face away from the medicament outlet end and on an inlet side of the medicament outlet end;
• the first stop having a facial-facing surface forming a vertical plane bisecting the device, configured to face in a patient distal-to-proximal direction when in use and perpendicular to a longitudinal axis of the body and being configured to engage a facial surface of one or more maxillary incisors of a user in an as-used position of the mouthpiece installed within a mouth of the user;
• the second stop having a lingual-facing surface forming a second vertical plane bisecting the device, configured to face in a patient proximal-to-distal direction when in use and perpendicular to the longitudinal axis of the body and being configured to engage a lingual surface of one or more mandibular incisors of the user in the as-used position of the mouthpiece;
• and
• the first stop is disposed nearer to the medicament outlet end of the mouthpiece than the second stop, such that a lower mandible of the user is advanced away from the medicament outlet end and relative to the one or more maxillary incisors along a longitudinal axis of the mouthpiece when the mouthpiece is in the as-used position.

A dry powder inhaler comprising a mouthpiece, wherein the mouthpiece comprises:

• an inlet;
• a first stop on a first side;
• a second stop on a second side opposite the first side;
• a medicament-outlet end opposite the inlet;
• a longitudinal axis, the inlet and medicament outlet end connected by a tubular passageway extending therebetween;
• wherein:
• the first stop is disposed on the first side to face toward the medicament outlet end and on an inlet side of the medicament outlet end;
• the second stop is disposed on the second side to face away from the medicament outlet end and on an inlet side of the medicament outlet end;
• the first stop having a facial-facing surface forming a vertical plane bisecting the device, configured to face in a patient distal-to-proximal direction when in use and perpendicular to a longitudinal axis of the body and is configured to engage a facial surface of one or more maxillary incisors of the user in an as-used position of the mouthpiece installed within a mouth of the user;
• the second stop having a lingual-facing surface forming a second vertical plane bisecting the device, configured to face in a patient proximal-to-distal direction when in use and perpendicular to the longitudinal axis of the body and being configured to engage a lingual surface of one or more mandibular incisors of the user in the as-used position;
• the first stop is disposed nearer to the medicament outlet end of the mouthpiece than the second stop, such that a lower mandible of the user is advanced away from the medicament outlet end and relative to the one or more maxillary incisors along a longitudinal axis of the mouthpiece when the mouthpiece is in the as-used position.

An apparatus comprising:

• an inlet port configured to receive an aerosol;
• a mouthpiece configured to deliver such an aerosol to a user, the mouthpiece comprising a first stop having a facial-facing surface forming a vertical plane bisecting the device, configured to face in a patient distal-to-proximal direction when in use and perpendicular to a longitudinal axis of the body and configured to engage a facial surface of one or more maxillary incisors of the user in an as-used position of the mouthpiece installed within a mouth of the user and a second stop having a lingual-facing surface forming a second vertical plane bisecting the device, configured to face in a patient proximal-to-distal direction when in use and perpendicular to the longitudinal axis of the body and configured to engage a lingual surface of one or more mandibular incisors of the user in the as-used position, wherein, in the as-used position, a medicament outlet end of the mouthpiece is positioned on a lingual side of the one or more mandibular incisors and the one or more maxillary incisors;
• and
• a hollow body having a longitudinal axis disposed between the inlet port and the mouthpiece and extending therebetween, the hollow body configured to facilitate fluid communication of an aerosol from the inlet port to the mouthpiece;
• wherein the mouthpiece includes an offset configuration of the first stop and second stop to impart a selected amount of mandibular advancement of the user's lower mandible relative to the user's maxilla and along a longitudinal axis of the mouthpiece during aerosol delivery;
• wherein the mouthpiece has a cross-sectional area associated therewith, wherein the cross-sectional area is defined by a vertical component and a horizontal component, and wherein the vertical component defines the amount of vertical opening of the user's mouth during aerosol delivery, and
• wherein at least one of the offset, the vertical component, or a combination of the offset and vertical component are configured to provide a predetermined deposition of such an aerosol within the user's lungs.