Breath actuated nebulizer

• US 10,463,813 B2
• Filed: 09/19/2014
• Issued: 11/05/2019
• Est. Priority Date: 09/21/2013
• Status: Active Grant

• Current Assignee: Flexicare (Group) Limited (Medicare Marketing SA)
• Original Assignee: Inspirx, Inc.
• Inventors: Vasandani, Paresh, Shukla, Vijay, Hossain, K. Mosaddeq, Toddywala, Rohinton D.
• Primary Examiner(s): Yu, Justine R
• Assistant Examiner(s): Morales, Alexander
• Application Number:
  US15/023,488
• Publication Number:
  US 20160228656A1
• Time in Patent Office: 1,873 Days
• Field of Search: 12820018, 128 14, 128 21, 12820313, 12820621, 12820714, 128 16, 239338, 239370, 2394285
• CPC Class Codes: A61M 11/002 by flow deviation causing inertial separation of transported particles
• CPC Class Codes: A61M 11/06 of the injector type
• CPC Class Codes: A61M 15/0015 located upstream of the dispenser, i.e. not traversed by the product
• CPC Class Codes: A61M 15/0018 with exhalation check valves
• CPC Class Codes: A61M 15/0021 Mouthpieces therefor
• CPC Class Codes: A61M 15/0091 mechanically breath-triggered
• CPC Class Codes: A61M 16/06 Respiratory or anaesthetic masks
• CPC Class Codes: A61M 16/0825 with ball-sockets
• CPC Class Codes: A61M 16/1065 in the expiratory path
• CPC Class Codes: A61M 16/14 by mixing different fluids, one of them being in a liquid phase
• CPC Class Codes: A61M 2205/581 by audible feedback
• CPC Class Codes: A61P 11/00 Drugs for disorders of the respiratory system
• CPC Class Codes: A61P 11/06 Antiasthmatics

Abstract

A breath actuated nebulizer for administration of an inhaled medication to a patient is provided with a generally cylindrical body in a horizontal orientation to the patient. Within the body is a Venturi configured to nebulize a liquid medication in a reservoir. Within the body is a shaft integrated with a baffle and diaphragm that slides horizontally in response to the breathing of a patient. During inhalation by the patient, the diaphragm flexes shifting the baffle over the Venturi, allowing nebulization to occur. When the patient exhales, the diaphragm flexes to a default position in which the baffle is distal to the Venturi, thereby stopping the nebulization. The diaphragm is biased to rest in this default position until the patient inhales again.

Claims

1. A breath triggered nebulizer for the administration of inhaled medication to a patient, said nebulizer having an airway and horizontal and vertical axes, comprising:

a) a horizontally oriented cylindrical body defining an upper chamber airway, said horizontal oriented cylindrical body has a distal end and a proximal end;

b) a vertically oriented lower chamber having therein a liquid reservoir containing a medicament in solution, wherein said liquid reservoir defines the horizontal axis;

c) a pressurized gas inlet port in fluid communication with a gas jet;

d) a liquid channel surrounding or adjacent the gas inlet port, said liquid channel in fluid communication with a liquid orifice, wherein the gas jet is adjacent to the liquid orifice, and the gas jet is oriented vertically;

e) a horizontally movable shaft assembly within the upper chamber airway, the shaft assembly comprising a flexible diaphragm distal from the gas jet and a baffle at an end of the shaft assembly opposite the flexible diaphragm, said flexible diaphragm being located at said distal end of the horizontally oriented cylindrical body, the shaft assembly further comprising (i) a first position wherein the baffle is at a predetermined distance from the gas jet such that a pressure differential is created in the liquid channel that draws the medicament solution through the liquid channel and causes nebulization of the medicament solution by the interaction of the gas jet and liquid orifice, and (ii) a second position wherein the baffle is at a distance distal from the gas jet such that the pressure differential is insufficient to draw liquid into the channel and no nebulization occurs;

f) whereby the baffle movement is controlled by a tab extending from the shaft assembly between the first position and the second position at a fixed vertical distance relative to the gas jet;

g) whereby the shaft assembly is moved from the second position to the first position during inhalation by the patient which flexes the diaphragm in a forward direction, and whereby the shaft assembly shifts to the second position when the patient is not inhaling, which flexes the diaphragm in a posterior direction to a posterior position; and

h) wherein the nebulized medicament solution is inhaled by the patient thereby delivering nebulized medicament solution to lungs of the patient.

2. The nebulizer of claim 1 wherein an inhalation mask is connected to the nebulizer and the nebulized medicament solution is transmitted through the inhalation mask during inhalation.

3. The nebulizer of claim 1 wherein a mouthpiece is connected to the nebulizer and the nebulized medicament solution is transmitted through the mouthpiece during inhalation.

4. The nebulizer of claim 1 wherein an audio signal is produced when the shaft assembly moves from the first position to the second position.

5. The nebulizer of claim 4 wherein the shaft assembly further comprises a protrusion at the distal end of the shaft assembly comprising the flexible diaphragm, the nebulizer further comprising an end cap adjacent the flexible diaphragm, wherein the audio signal is a clicking sound produced by the protrusion contacting a part of the end cap.

6. The nebulizer of claim 1 wherein said gas jet and liquid orifice are on the same horizontal plane.

7. The nebulizer of claim 1 wherein the liquid orifice comprises one or more holes on top of the liquid channel.

8. The nebulizer of claim 1 wherein the liquid orifice comprises a concentric tubular opening in a concentric relationship to the gas jet.

9. The nebulizer of claim 1 wherein the baffle is responsive to inspiratory flow velocity in the range of 0.5 L/min to 15 L/min.

10. The nebulizer of claim 1 further comprising a breath enhanced valve system that improves nebulization and inhalation thereof comprising a one-way vent that opens during inhalation to permit external air entry into the upper chamber.

11. The nebulizer of claim 1 further comprising an inhalation mask or mouthpiece in fluid communication with the airway, wherein an exhalation valve is present on the airway.

12. The nebulizer and mask of claim 11, wherein the exhalation valve has a filter that traps substantially all exhaled medication from being expelled from the nebulizer.

13. A method of administering an inhaled medicament to a patient with a nebulizer comprising:

a) providing the nebulizer of claim 1;

b) inhaling air from the horizontally oriented cylindrical body to flex the diaphragm and move the shaft assembly from the second position to the first position;

c) creating a pressure differential in the liquid channel to draw the medicament solution through the liquid channel causing the nebulization of the medicament solution; and

d) transmitting the nebulized medicament solution to the lungs of the inhaling patient.