Respiratory mask with disposable cloth body

• US 9,308,343 B2
• Filed: 03/14/2013
• Issued: 04/12/2016
• Est. Priority Date: 02/19/2008
• Status: Active Grant

• Current Assignee: Circadiance, LLC
• Original Assignee: Circadiance, LLC
• Inventors: Groll, David, Mahofski, Ronnie E., Scandinaro, Nadine
• Primary Examiner(s): YOUNG, RACHEL T
• Application Number:
  US13/831,239
• Publication Number:
  US 20140090649A1
• Time in Patent Office: 1,125 Days
• US Class Current: 1/1
• CPC Class Codes: A61M 16/06 Respiratory or anaesthetic masks
• 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 16/0683 Holding devices therefor
• CPC Class Codes: A61M 16/0694 Chin straps
• CPC Class Codes: A61M 16/0825 with ball-sockets
• CPC Class Codes: A61M 16/0875 Connecting tubes
• CPC Class Codes: A61M 16/125 Diluting primary gas with ambient air
• CPC Class Codes: A61M 2205/0238 the material being a coating or protective layer
• CPC Class Codes: A61M 2210/0618 Nose

Abstract

The invention is a frameless, disposable cloth body for use with a respiratory mask, such as for continuous positive airway pressure therapy for those having sleep apnea. The cloth body is inflatable and moisture-vapor breathable and has an inner side having a nasal interface portion disposed on it and an outer side, and also has a circular aperture formed in a central location on the body, sized to sealingly receive an air delivery arrangement. The cloth body also has a pair of wings on opposite sides with slits arranged at optimal angles for receiving headgear straps.

Claims

1. A frameless inflatable respiratory mask comprising:

a cloth body having a circular aperture, an inner side and an outer side, the inner side having a nasal interface portion disposed thereon;

the nasal interface portion comprising an upper lip portion having an inner section and at least one wrapped inelastic section loosely sleeved around the inner section;

the body further having a pair of wings disposed on opposite sides laterally;

an air delivery arrangement adapted to sealingly deliver air through the circular aperture;

an exhalation system disposed on the mask; and

a headgear for securing and adjusting the mask on a user'"'"'s head adjustably disposed on the wings;

whereby air that is delivered to the mask via the air delivery arrangement inflates the cloth body to enable air to be delivered at a therapeutic pressure.

2. The frameless inflatable respiratory mask of claim 1, wherein the cloth body is manufactured with an inelastic yet flexible material.

3. The frameless inflatable respiratory mask of claim 2, wherein the wings are comprised of two layers of the material.

4. The frameless inflatable respiratory mask of claim 2, wherein the wings are comprised of a heavier material that is thicker than the inelastic yet flexible material.

5. The frameless inflatable respiratory mask of claim 2, wherein the material is a polyester cloth.

6. The frameless inflatable respiratory mask of claim 2, wherein the material has an impermeable to air coating.

7. The frameless inflatable respiratory mask of claim 6, wherein the coating is either a polyester film or a polyurethane film.

8. The frameless inflatable respiratory mask of claim 1, wherein the cloth body shape is created by sewing the body together with thread, the sewing creating seams in the body.

9. The frameless inflatable respiratory mask of claim 1, wherein the cloth body has a first uninflated configuration and a second inflated configuration different than the first uninflated configuration.

10. The frameless inflatable respiratory mask of claim 1, wherein the nasal interface portion is manufactured with an elastic moisture-vapor breathable material.

11. The frameless inflatable respiratory mask of claim 10, wherein the elastic moisture-vapor breathable material is a combination of nylon, elastane and polyurethane.

12. The frameless inflatable respiratory mask of claim 1, wherein the nasal interface portion further comprises a nose-cradling portion wherein the amount of material measured laterally is greater than the amount of material used for the upper lip portion.

13. The frameless inflatable respiratory mask of claim 1, wherein the air delivery arrangement is removably sealed to the cloth body.

14. The frameless inflatable respiratory mask of claim 1, wherein the air delivery arrangement is sealed to the cloth body with a threaded projection that passes from the inner side through the aperture and connects to a clamping portion on the outer side.

15. The frameless inflatable respiratory mask of claim 1, wherein the exhalation system comprises a plurality of apertures in the cloth body.

16. The frameless inflatable respiratory mask of claim 15, wherein the exhalation system further comprises seams.

17. The frameless inflatable respiratory mask of claim 1, wherein the headgear further comprises a tether strap with a first end disposed on the headgear and a second end forming an aperture to frictionally receive an air hose therethrough, the strap being of sufficient rigidity to keep the air hose at least a predetermined distance away from the user'"'"'s face.

18. The frameless inflatable respiratory mask of claim 1, wherein the wings each have a distal edge, each distal edge having a plurality of slits formed therein for receiving headgear straps.

19. The frameless inflatable respiratory mask of claim 18, wherein the plurality of slits include an outer slit oriented parallel to each distal edge for receiving an upper strap and an inner slit adjacent to each outer slit, oriented at an angle to each outer slit to receive a lower strap.

20. The frameless inflatable respiratory mask of claim 19, wherein the angle is substantially seventy degrees.

21. The frameless inflatable respiratory mask of claim 18, wherein the headgear straps are adapted to curve around the ear and the wings are adapted to curve under the eyes to be more comfortable for the user.

22. The frameless inflatable respiratory mask of claim 1, wherein the headgear further comprises a tether strap having sufficient stiffness to keep an air hose substantially away from the user'"'"'s face during CPAP therapy.

23. A disposable body for a respiratory mask comprising a cloth body having an inner side, an outer side, the cloth body forming a circular aperture sized to sealingly receive an air delivery arrangement;

a pair of wings disposed on opposite lateral sides of the body for receiving headgear straps; and

a nasal interface portion disposed on the inner side of the cloth body for securely cradling a nose of a user, the nasal interface portion comprising an upper lip portion having an inner section and at least one wrapped inelastic section loosely sleeved around the inner section.

24. A kit comprising:

one or more disposable cloth bodies having an inner side, an outer side, an aperture formed in the one or more bodies, a pair of wings disposed on opposite lateral sides of the one or more bodies for receiving headgear straps; and

a nasal interface portion disposed on the inner side of the one or more cloth bodies for securely cradling a nose of a user, the nasal interface portion comprising an upper lip portion having an inner section and at least one wrapped inelastic section loosely sleeved around the inner section, and packaging capable of housing one or more of the one or more cloth bodies.

25. A method of delivering air at a therapeutic pressure to a user comprising:

providing a respiratory mask having cloth body forming a circular aperture, an inner side, and an outer side, the inner side having a nasal interface portion disposed thereon, the nasal interface portion comprising an upper lip portion having an inner section and at least one wrapped inelastic section loosely sleeved around the inner section, the body further having a pair of wings disposed on opposite sides laterally, an air delivery arrangement adapted to sealingly deliver air through the circular aperture;

an exhalation system disposed on the mask, and a headgear for securing and adjusting the mask on a user adjustably disposed on the wings;

whereby air that is delivered to the mask via the air delivery arrangement inflates the cloth body to enable air to be delivered at a therapeutic pressure;

securing the respiratory mask to the user such that the respiratory mask covers a nose of the user; and

delivering air to the user via the mask.