Nasal devices

• US 8,146,589 B2
• Filed: 03/28/2003
• Issued: 04/03/2012
• Est. Priority Date: 03/28/2002
• Status: Active Grant

• Current Assignee: OptiNose, Inc.
• Original Assignee: OptiNose AS (OptiNose, Inc.)
• Inventors: Djupesland, Per Gisle
• Primary Examiner(s): Ostrup, Clinton T
• Application Number:
  US10/509,552
• Publication Number:
  US 20050235992A1
• Time in Patent Office: 3,294 Days
• Field of Search: 128/201.13, 128/203.12, 128/203.14, 128/203.15, 128/203.18, 128/203.19, 128/203.22, 128/203.23, 128/203.25, 128/203.24, 128/203.29, 128/204.18, 128/204.21, 128/204.26, 128/205.24, 128/205.25, 128/913
• US Class Current: 128/203.18
• CPC Class Codes: A61M 15/002 with air flow regulating means
• CPC Class Codes: A61M 15/0065 Inhalators with dosage or measuring devices A61M15/0028 takes precedence; dosage devices incorporated in aerosol cans B65D83/52
• CPC Class Codes: A61M 15/009 using medicine packages with incorporated spraying means, e.g. aerosol cans pocket atomiser of the injector type A61M11/08
• CPC Class Codes: A61M 15/0098 Activated by exhalation
• CPC Class Codes: A61M 15/08 Inhaling devices inserted into the nose
• CPC Class Codes: A61M 16/0666 Nasal cannulas or tubing devices for improving normal breathing through the nose A61F5/08; nose filters A62B23/06; outside holding devices A61M25/02
• CPC Class Codes: A61M 16/20 Valves specially adapted to medical respiratory devices
• CPC Class Codes: A61M 16/202 electrically actuated
• CPC Class Codes: A61M 16/204 used for inhalation control
• CPC Class Codes: A61M 16/205 used for exhalation control
• CPC Class Codes: A61M 2016/0021 with a proportional output signal, e.g. from a thermistor
• CPC Class Codes: A61M 2016/0039 in the inspiratory circuit
• CPC Class Codes: A61M 2202/064 Powder

Abstract

A nasal delivery device (11) for delivering substance to a nasal airway (1) of a subject, comprising: first and second nosepiece units (17, 19), each including a nosepiece (21, 23) for fitting to respective nostrils of a subject; at least one substance supply unit (13, 15) for supplying substance for delivery to the nasal airway (1) of the subject; and a valve unit (35, 37) for selectively fluidly connecting the at least one substance supply unit (13, 15) alternately to respective ones of the nosepiece units (17, 19).

Claims

1. A nasal delivery device for delivering substance to a nasal airway of a subject, comprising:

first and second nosepiece units, each including a nosepiece for fitting to respective nostrils of a subject;

at least one substance supply unit for supplying a metered dose of substance for delivery to the nasal airway of the subject;

a valve unit for selectively fluidly connecting the at least one substance supply unit alternately to respective ones of the nosepiece units, the valve unit configured to alternately (i) establish communication between the at least one substance supply unit and the first nosepiece unit and (ii) establish communication between the at least one substance supply unit and the second nosepiece unit; and

a mouthpiece through which the subject in use exhales to cause closure of the oropharyngeal velum of the subject during delivery of substance.

2. The delivery device of claim 1, further comprising:

a gas supply channel for supplying a gas flow for entraining substance supplied by the at least one substance supply unit.

3. The delivery device of claim 2, wherein the mouthpiece is fluidly connected to the gas supply channel, whereby the gas flow is an air flow developed by an exhalation breath of the subject.

4. The delivery device of claim 2, further comprising:

a gas supply unit which is fluidly connected to the gas supply channel for delivering a gas flow through the gas supply channel.

5. The delivery device of claim 4, wherein the gas supply unit is an exhalation breath actuatable unit which is fluidly connected to the mouthpiece such as to be actuated on exhalation by the subject.

6. The delivery device of claim 2, wherein the device is configured to deliver the gas flow at a driving pressure which is such as to cause the gas flow to flow around the posterior margin of the nasal septum and through the nasal airway and wherein the valve unit is configured alternatively (i) to vent the nasal airway of the subject through the second nosepiece unit when the at least one substance supply unit is in communication with the first nosepiece and (ii) to vent the nasal airway of the subject through the first nosepiece unit when the at least one substance supply unit is in communication with the second nosepiece.

7. The nasal delivery device of claim 6, wherein the device is configured such that the venting occurs through the respective nosepiece unit to the atmosphere.

8. The delivery device of claim 1, further comprising:

at least one flow resistor to which a nosepiece unit is vented.

9. The delivery device of claim 8, wherein the flow resistor has a fixed flow resistance for providing a fixed flow resistance to the gas flow.

10. The delivery device of claim 8, wherein the flow resistor is a progressive resistor for progressively providing an increasing flow resistance to the gas flow.

11. The delivery device of claim 10, wherein the progressive resistor comprises an expandable member which provides a progressively increasing resistance to the gas flow.

12. The delivery device of claim 1, further comprising:

a control unit for controlling the valve unit such as to provide for alternate delivery of substance through respective ones of the first and second nosepiece units.

13. The delivery device of claim 1, comprising:

a single substance supply unit for supplying substance for delivery alternately to respective ones of the first and second nosepiece units.

14. The delivery device of claim 1, comprising:

first and second substance supply units for supplying substance for delivery to respective ones of the first and second nosepiece units.

15. The delivery device of claim 1, wherein the valve unit comprises first and second valves, each being fluidly connected to a respective one of the first and second nosepiece units.

16. A method of delivering substance to a nasal airway of a subject, comprising the steps of:

taking the device of claim 1;

fitting the first and second nosepiece units to respective nostrils of a subject;

delivering a metered dose of substance alternately through respective ones of the nosepiece units using the at least one substance supply unit and the valve unit; and

exhaling through the mouthpiece during delivery of substance to cause closure of the oropharyngeal velum of the subject.

17. The method of claim 16, wherein substance is delivered in a gas flow.

18. The method of claim 17, wherein the gas flow is an air flow developed by an exhalation breath of the subject.

19. The method of claim 17, wherein the gas flow is a gas flow separate to an exhalation breath of the subject.

20. The method of claim 17, wherein substance is delivered alternately to one of the nosepiece units and the other of the nosepiece units is vented, such that, where the gas flow is at a driving pressure which is such as to cause the gas flow to flow around the posterior margin of the nasal septum and through the nasal airway, the gas flow delivered to the one nosepiece unit is vented through the other nosepiece unit.

21. The method of claim 20, wherein the gas flow is vented through a flow resistor.

22. The method of claim 21, wherein the flow resistor has a fixed flow resistance and provides a fixed flow resistance to the gas flow.

23. The method of claim 21, wherein the flow resistor is a progressive resistor which provides a progressively increasing flow resistance to the gas flow.

24. The method of claim 23, wherein the progressive resistor comprises an expandable member which provides a progressively increasing resistance to the gas flow.

25. The method of claim 20, wherein the device is configured such that the venting occurs through the respective nosepiece unit to the atmosphere.

26. The method of claim 16, wherein substance is supplied from a single substance supply unit.

27. The method of claim 16, wherein substance is supplied to the first and second nosepiece units from respective ones of first and second substance supply units.

28. A nasal delivery device for delivering substance to a nasal airway of a subject, comprising:

a mouthpiece configured to receive an exhalation breath from the subject to cause closure of the oropharyngeal velum of the subject;

at least one delivery unit for delivering a metered dose of substance to a nasal airway of the subject on exhalation by the subject; and

an exogenous gas supply unit for supplying a gas flow into the nasal airway of the subject and configured to provide an alternating pressure in the nasal airway of the subject during the exhalation breath.

29. The delivery device of claim 28, wherein the exogenous gas supply unit is an exhalation breath actuatable unit which is fluidly connected to the mouthpiece such as to be actuated on exhalation by the subject.

30. A method of delivering substance to a nasal airway of a subject, comprising the steps of:

taking the device of claim 28;

delivering a metered dose of substance to a nasal airway of a subject using the at least one delivery unit;

the subject delivering an exhalation breath through the mouthpiece during delivery of the substance by the at least one delivery unit, to cause closure of the oropharyngeal velum of the subject; and

the exogenous gas supply unit supplying an exogenous gas flow having an alternating pressure into the nasal airway of the subject during the exhalation breath.

31. The nasal delivery device of claim 28, further comprising a valve unit configured to alternately (i) establish communication between the exogenous gas supply unit and a first nostril of the subject and (ii) establishing communication between the exogenous gas supply unit and the second nostril.

32. A method of delivering substance to a nasal airway of a subject, comprising the steps of:

taking the device of claim 31;

delivering a metered dose of substance to a nasal airway of a subject using the at least one delivery unit;

the subject delivering an exhalation breath through the mouthpiece during delivery of the substance by the at least one delivery unit, to cause closure of the oropharyngeal velum of the subject; and

supplying an exogenous gas flow having an alternating pressure into the nasal airway of the subject during the exhalation breath using the exogenous gas supply unit and the valve unit such that a communication is alternately established between the exogenous gas supply unit and (i) a first nostril of the subject and (ii) a second nostril of the subject.

33. A nasal delivery device for delivering substance to a nasal airway of a subject, comprising:

a mouthpiece configured to receive an exhalation breath from the subject to cause closure of the oropharyngeal velum of the subject;

at least one delivery unit for delivering a metered dose of substance to a nasal airway of the subject on exhalation by the subject; and

an exogenous gas supply unit configured to alternately deliver and withdraw a volume of exogenous gas entraining the substance through the nasal airway of the subject during the exhalation breath, such as to cause the entrained substance to be flushed repeatedly through the nasal airway in alternate directions.

34. A method of delivering substance to a nasal airway of a subject, comprising the steps of:

taking the device of claim 33;

delivering a metered dose of substance to a nasal airway of a subject using the at least one delivery unit;

the subject delivering an exhalation breath through the mouthpiece during delivery of the substance by the at least one delivery unit, to cause closure of the oropharyngeal velum of the subject; and

the exogenous gas supply unit alternately delivering and withdrawing a volume of exogenous gas entraining the substance through the nasal airway of the subject during the exhalation breath such as to cause the entrained substance to be flushed repeatedly through the nasal airway in alternate directions.