Nasal positive airway pressure apparatus and method

• US 5,477,852 A
• Filed: 11/19/1993
• Issued: 12/26/1995
• Est. Priority Date: 10/29/1991
• Status: Expired due to Term

• Current Assignee: AIRWAYS ASSOCIATES
• Original Assignee: US Airways Incorporated (American Airlines Group Incorporated)
• Inventors: Landis, Robert M., Disanza, Wayne W.
• Primary Examiner(s): Burr, Edgar S.
• Assistant Examiner(s): RACITI, ERIC
• Application Number:
  US08/155,479
• Time in Patent Office: 767 Days
• Field of Search: 128/207.15, 128/207.18, 128/DIG. 26, 128/911, 128/912, 128/207.16, 128/207.17, 128/204.11, 128/204.12, 128/204.18, 128/200.24 , 128/200.26, 128/201.22, 128/203.21, 128/205.25, 606/191, 606/192, 606/196, 604/94
• US Class Current: 128/207.18
• CPC Class Codes: A61M 16/0633 with forehead support
• 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 16/0825 with ball-sockets
• CPC Class Codes: A61M 16/0833 T- or Y-type connectors, e.g. Y-piece

Abstract

A nasal positive airway pressure device is provided having a pair of nasal members each having a cannula tip to be inserted into the nares of the patient. Each cannula is tapered from a substantially circular cross-section outside the patient'"'"'s nostril to a substantially oval cross-section at the tip inserted into the nostril. An inflatable cuff surrounds each cannula with the interior space of the cuff communicating with the lumen of the cannula through at least one aperture in the side wall of the cannula. The nasal members are connected to one or more flexible hoses which, in turn, are connected to a source of positive air pressure. In use, positive air pressure is supplied to the each cannula tip through the air hoses and nasal members. The positive air pressure inflates the cuffs to hold the nasal members in place and to effect treatment, The tapered tip configuration, soft inflatable cuffs and adjustable positioning of the nasal members and tip provide a device which is more comfortable to the user. A variable diameter orifice for nasal positive airway pressure treatment is also contemplated.

Claims

1. A device for treatment of sleep apnea comprising:

a pair of nasal members, at least a portion of each said nasal member defining a cannula having lumens and configured and dimensioned to fit within the nares of a patient, each said nasal member having a substantially oval cross-section at the open distal tip thereof, a substantially circular cross-section proximal of said distal tip, and a tapered body section between said oval cross-section and said circular cross-section, and at least one aperture through the sidewall of said tapered body section;

a pair of inflatable cuff members, each said cuff member surrounding at least a portion of said tapered body section of one of said nasal member and enclosing said aperture, the lumen of said nasal member and the interior said cuff in gaseous communication through said aperture; and

a source of pressurized air connected to said nasal members to deliver pressurized air to the lumen of said nasal members.

2. The apparatus of claim 1 further comprising a pair of flexible nasal tubes each connected at a first end thereof to one of said nasal members and at a second end thereof to said source of pressurized air.

3. The apparatus of claim 1 wherein said nasal members include at least one vent hole.

4. The apparatus of claim 1 further comprising securing means for securing said apparatus relative to the head of a patient.

5. The apparatus of claim 4 wherein said securing means comprise a strap for engaging the apparatus and surrounding the head of a patient to secure the apparatus to the head of the patient.

6. The apparatus of claim 1 wherein said source of pressurized air is a substantially constant pressure source.

7. The apparatus of claim 1 wherein said source of pressurized air provides at least two different pressure conditions of air.

8. The apparatus of claim 2 wherein said nasal members are rotatably mounted to said flexible nasal tubes.

9. The apparatus of claim 8 wherein said nasal members are mounted to said nasal members by at least one rib in slot engagement.

10. The apparatus of claim 1 wherein said nasal member is made of a substantially rigid plastic material.

11. The apparatus of claim 1 wherein said inflatable cuff is made of a substantially inelastic material.

12. The apparatus of claim 11 wherein said inelastic material is plastic.

13. The apparatus of claim 12 wherein said inelastic plastic material is polyurethane.

22. The apparatus of claim 2 wherein said flexible tubes are expandable corrugated tubes, and whereby the relative position of said nasal members may be adjusted further by longitudinally expanding one or both of said expandable corrugated tubes.

14. A tip member for an apparatus for treating sleep apnea comprising a nasal tip member having a sidewall defining inner and outer surfaces and at least one aperture through said side wall, a first open end, a second open end and a body section between said first and second open ends, said first end having a substantially oval cross-section, said nasal tip member defining a cannula configured and dimensioned for insertion into a patient'"'"'s nares, and an inflatable cuff secured to said outer surface off said tip member surrounding at least a portion of said tip member and enclosing said aperture, the interior space of said inflatable cuff in gaseous communication with the lumen of said nasal tip member through said aperture.

15. The tip member of claim 14 wherein said second open end has a substantially circular cross-section and said body section is tapered from said first end to said second end.

16. The tip member of claim 14 wherein said cuff extends slightly beyond said first open end in an inflated condition.

17. A method of treating sleep apnea comprising:

providing an apparatus for treating sleep apnea including;

(i) a pair of nasal tip members, each said tip member having a substantially oval first open end, a substantially circular second open end, and a tapered body section between said first and second ends, and at least one aperture through the sidewall of said tapered body section, each said tip member further including an inflatable cuff member surrounding at least a portion of said tapered body section and enclosing said aperture, each said nasal tip member defining a cannula configured and dimensioned for insertion into a patient'"'"'s nares;

(ii) a pair of nasal members rotatably mounted to said pair of nasal tip members at said second end of said tip members; and

(iii) a source of pressurized air to simultaneously effect respiratory treatment to a patient and communicating with said nasal members to supply positive air pressure through said nasal members to said tip members;

rotatably adjusting said nasal tip members relative to said nasal members;

inserting said nasal tip members and inflatable cuffs into the nares of a patient to be treated;

activating said source of pressurized air to supply air to said nasal tip members to inflate said cuffs under pressure of said pressurized air and cause said cuffs to contact the patient'"'"'s nares to hold said nasal tip members within the patient'"'"'s nares as treatment is effected with the pressurized air.

18. In an apparatus for the treatment of sleep disorders having at least one nasal member with a tip defining a lumen, at least a portion of the tip configured and dimensioned to be inserted into the nares of a patient, and a source of pressurized air connected to said at least one nasal member to supply positive air pressure to the lumen, the improvement comprising a variable orifice member spaced from the portion of said tip configured and dimensioned to be inserted into the nare of the patient, said variable orifice member in gaseous communication with the lumen and defining a variable orifice assuming a first position having a first diameter at a first gas pressure and a second, expanded position having a second diameter greater than said first diameter at a second, increased gas pressure.

19. The apparatus of claim 18 wherein the apparatus comprises a pair of nasal members each having a tip portion configured and dimensioned to be inserted into the nares of a patient.

20. The apparatus of claim 18 wherein said variable orifice member comprises a stretchable material having an aperture therethrough.

21. A method of treating sleep apnea comprising:

providing an apparatus for treating sleep apnea including;

(i) a pair of hollow nasal members having a body section and a tip configured and dimensioned to be inserted into the nares of a patient, each said nasal member including at least one variable aperture through the sidewall of said body section;

(ii) a source of pressurized air communicating with said nasal members;

inserting said tip members into the nares of a patient to be treated;

activating said source of pressurized air to supply air to said hollow tip members to provide positive air pressure to the patient'"'"'s nares, said variable aperture assuming a first diameter during inhalation by the patient and a second, enlarged diameter during exhalation by the patient.

23. A device for treatment of sleep apnea comprising:

a pair of nasal members, at least a portion of each said nasal member defining a cannula configured and dimensioned to fit within the nares of a patient, each said nasal member having a first open end at the distal tip thereof, a second open end proximal of said distal tip, and a body section between said first and second ends defining a lumen between said first and second ends, and at least one aperture through the sidewall of said body section;

a pair of inflatable cuff members, each said cuff member surrounding at least a portion of said body section of one of said nasal members and enclosing said aperture, the lumen of said nasal member and the interior of said cuff in gaseous communication through said aperture; and

a source of pressurized air connected to said nasal members to deliver pressurized air to the lumen of said nasal members.

24. The apparatus according to claim 23 further comprising at least one vent hole in gaseous communication with the lumen of said nasal members.

25. A method of treating sleep apnea comprising:

inserting a pair of nasal tip members into the nares of a patient to be treated, each said inserted nasal tip member having a first open end, a second open end, a body section between said first and second ends to define a lumen connecting said first and second open ends, and at least one aperture through the sidewall of said body section, each said inserted nasal tip member further including an inflatable cuff member surrounding at least a portion of said body section and enclosing said aperture;

activating a source of pressurized air connected to the lumen of said nasal tip members to supply air to said lumen to inflate said cuffs under pressure of said pressurized air and cause said cuffs to contact the patient'"'"'s nares to hold said nasal tip members within the patient'"'"'s nares.

26. A device for treatment of sleep apnea comprising:

a pair of nasal members, at least a portion of each said nasal member defining a cannula configured and dimensioned to fit within the nares of a patient, each said nasal member having a first open end at the distal tip thereof, a second open end proximal of said distal tip, and a body section between said first and second ends defining a lumen between said first and second ends, and at least one aperture through the sidewall of said body section;

a pair of inflatable cuff members, each said cuff member surrounding at least a portion of said body section of one of said nasal members and enclosing said aperture, the lumen of said nasal member and the interior of said cuff in gaseous communication through said aperture;

a pair of substantially U-shaped rigid tubes, each said nasal member rotatably mounted to one U-shaped tube;

a pair of flexible corrugated tubes, each corrugated tube connected to one said U-shaped tube opposite said nasal members; and

a source of pressurized air connected to the ends of said flexible corrugated tubes opposite said U-shaped tubes to deliver pressurized air to the lumen of each nasal member through said U-shaped tubes.

27. The apparatus of claim 26 wherein each substantially rigid U-shaped tube includes at least one vent hole.

28. The apparatus of claim 27 wherein said vent hole comprises a variable orifice.