Method and apparatus comprising stepped mouthpiece for aerosol drug delivery

Patent metadata

Field	Value
Publication number	US-9956359-B2
Application number	US-200913131947-A
Country	US
Kind code	B2
Filing date	Nov 23, 2009
Priority date	Dec 23, 2008
Publication date	May 1, 2018
Grant date	May 1, 2018

Abstract

The invention of the present application relates to an apparatus to aid in administering inhaled pharmaceutical aerosol to a patient. The apparatus is used in conjunction with an aerosol delivery device. The apparatus comprises steps on the top and bottom of the apparatus, which when used aid the patient causes mandibular advancement, and opening of the mouth, causing opening of patient's airway, resulting in improved aerosol lung deposition. The invention also relates to a method of using such apparatus in a combination with an aerosol delivery device or a system, and to the mouthpiece of said apparatus.

First claim

What is claimed is:

1. An apparatus configured to aid aerosol delivery to a user comprising;
a body, the body comprising:
a proximal end comprising a medicament outlet;
a distal end opposite the proximal end; a longitudinal axis

a mouthpiece disposed at the proximal end, the mouthpiece being configured to be engaged within a mouth of the user in an as-used position of the apparatus, the mouthpiece comprising:
a first side;
a second side opposite the first side;

a first stop disposed on the first side of the mouthpiece, 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 the user when the mouthpiece is engaged within the mouth of the user in the as-used position; and
a second stop disposed on the second side of the mouthpiece opposite the first side, 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 engaged within the mouth of the user in the as-used position;
a tubular passageway communicating between the proximal end and the distal end, the passageway disposed along the longitudinal axis of the body forming a flow path to facilitate breathing by the user while the apparatus is in the as-used position; and
wherein the first stop and the second stop are disposed and arranged on the mouthpiece and between the medicament outlet and the distal end of the body and on opposite sides of the passageway such that a lower mandible of the user is advanced toward the distal end of the body and is advanced relative to the one or more maxillary incisors along the longitudinal axis of the body when the apparatus is in the as-used position.

2. The apparatus of claim 1 , wherein the first stop is offset along the longitudinal axis of the mouthpiece from the second stop and wherein the second stop is configured to extend the lower mandible toward the distal end by 1 to 6 mm from the first stop when the apparatus is in the as-used position.

3. The apparatus of claim 1 , wherein the first stop is offset along the longitudinal axis of the mouthpiece from the second stop and wherein the second stop is configured to extend the lower mandible toward the distal end by 3 to 6 mm from the first stop when the apparatus is in the as-used position.

4. The apparatus of claim 1 , wherein the distal end comprises an inlet port.

5. The apparatus of claim 4 , wherein the inlet port is adapted to attach to an inhaled pharmaceutical aerosol delivery device.

6. The apparatus of claim 4 , wherein the inlet port is adapted to attach to an inhaler.

7. 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.

8. The apparatus of claim 7 , wherein a mandibular advancement opens an upper airway of the user.

9. 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.

10. The mouthpiece of claim 9 , wherein the mouthpiece is further attached to an inhaled pharmaceutical aerosol delivery device.

11. The mouthpiece of claim 10 , wherein the inhaled pharmaceutical aerosol delivery device is a nebulizer.

12. The mouthpiece of claim 10 , wherein the inhaled pharmaceutical aerosol delivery device is an inhaler.

13. The mouthpiece of claim 12 , wherein the inhaler is a metered dose inhaler.

14. The mouthpiece of claim 12 , wherein the inhaler is a dry powder inhaler.

15. 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-p

Assignees

• Nikander Kurt Nerner
• Von Hollen Dirk
• Viviano John S
• Scarberry Eugene Nelson
• Petherbridge Ian Thomas
• Koninklijke Philips Nv

Inventors

• Nikander Kurt Nerner
• Von Hollen Dirk
• Viviano John S
• Scarberry Eugene Nelson
• Petherbridge Ian Thomas

Classifications

• A61M15/0021

  Mouthpieces therefor · CPC title

• A61M11/005

  using ultrasonics (spraying or atomising liquids using ultrasonic vibrations in general B05B17/06) · CPC title

• A61M15/00 Primary

  Inhalators {(drug delivery in endotracheal tubes A61M16/04)} · CPC title

• A61M2206/11

  Laminar flow · CPC title

• A61M15/009

  using medicine packages with incorporated spraying means, e.g. aerosol cans (pocket atomiser of the injector type A61M11/08) · CPC title