PATIENT INTERFACE SYSTEMS

• US 20100307502A1
• Filed: 10/22/2008
• Published: 12/09/2010
• Est. Priority Date: 10/22/2007
• Status: Active Grant

• Current Assignee: ResMed Pty Ltd. (ResMed Incorporated)
• Original Assignee: Resmed Limited (ResMed Incorporated)
• Inventors: Henry, Robert Edward, Hurst, Andrew, Hill, Phoebe Katherine, Rummery, Gerard Michael, Carroll, Fiona Catherine
• Granted Patent: US 8,636,007 B2
• Time in Patent Office: Days
• US Class Current: 128/205.25
• CPC Class Codes: A61M 16/06 Respiratory or anaesthetic masks
• CPC Class Codes: A61M 16/0611 with a gusset portion
• CPC Class Codes: A61M 16/0622 having an underlying cushion
• 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 16/0816 Joints or connectors
• CPC Class Codes: A61M 16/0825 with ball-sockets
• CPC Class Codes: A61M 16/0875 Connecting tubes
• CPC Class Codes: A61M 2205/0216 Materials providing elastic properties, e.g. for facilitating deformation and avoid breaking
• CPC Class Codes: A61M 2210/0618 Nose
• CPC Class Codes: Y10T 29/49826 Assembling or joining

Abstract

A patient interface system for delivery of a supply of air at positive pressure to the entrance of a patient'"'"'s airways for treatment of sleep disordered breathing includes an air delivery tube connected to a flexible portion of a plenum; a vent structure having sufficient rigidity to support its own weight under gravity and/or not to block or fold under tube movement or tube drag; and a patient interface structure. The patient interface structure includes a seal forming structure arranged on a top portion of the plenum; and a seal positioning and stabilizing structure connected to a flexible portion of the plenum. The seal-forming structure is substantially decoupled from a tube drag force.

Claims

1. A patient interface system for delivery of a supply of air at positive pressure to the entrance of a patient'"'"'s airways for treatment of sleep disordered breathing, comprising:

a patient interface structure, the patient interface structure comprising a flexible base and a seal-forming structure, the flexible base comprising a top portion and a lower portion defining a plenum, said flexible base forming at least part of a tube drag force decoupling system, the seal-forming structure being arranged on the top portion of the flexible base to form a seal on an underside of a patient'"'"'s nose in use;

a seal positioning and stabilizing structure connected to the top portion of the flexible base adjacent said seal-forming structure;

an air delivery tube connected to the lower portion of the flexible base; and

a vent structure having sufficient rigidity to support its own weight under gravity and/or not to block or fold under tube movement or tube drag.

2. A patient interface system according to claim 1, wherein the seal-forming structure comprises nasal pillows.

3. A patient interface system according to claim 1, wherein the seal-forming structure comprises nasal prongs.

4. A patient interface system according to claim 1, wherein the seal-forming structure comprises a foam cushion.

5. A patient interface system according to claim 1, wherein the seal-forming structure comprises a gel cushion.

6. A patient interface system according to claim 1, wherein the seal-forming structure comprises a flap cushion.

7. A patient interface structure for delivery of a supply of air at positive pressure to the entrance of a patient'"'"'s airways for treatment of sleep disordered breathing, comprising:

a seal-forming portion adapted to form a seal on an underside of a patient'"'"'s nose;

a base portion connected to the seal and located in use adjacent the top lip; and

a spring structure located between said seal-forming portion and said base portion, said spring structure being relatively more stiff on a side adjacent the top lip so as to rotate the base portion away from the top lip.

8. A patient interface structure according to claim 7, wherein the seal-forming portion comprises a frusto-conical portion and the spring structure comprises a thickened or stiffened portion of the base of the frusto-conical portion.

9. A patient interface structure according to claim 8, further comprising a thinned portion of the frusto-conical portion opposite the thickened or stiffened portion.

10. A patient interface structure according to claim 8, wherein the frusto-conical portion comprises an inner frusto-conical portion and an outer frusto-conical portion.

11. A patient interface structure for delivery of a supply of air at positive pressure to the entrance of a patient'"'"'s airways for treatment of sleep disordered breathing, comprising:

a flexible base portion having a first side adapted for positioning adjacent an underside of a patient'"'"'s nose in use, said flexible base having a second side opposite said first side and including an orifice on said second side adapted to receive the supply of air, said flexible base portion having a flexible side-wall defining a plenum, said flexible side wall being structured to hold its shape before pressurization and located between said first side and said second side,

a seal-forming structure connected to the first side of the flexible base portion; and

said patient interface structure further comprising

first and second lateral side arms connected to the flexible base portion on said first side substantially adjacent the seal-forming structure, said first and second lateral side arms being adapted to receive a headgear tension and direct said headgear tension to the base portion.

12. A patient interface structure according to claim 11, wherein the plenum comprises a bellows region adapted to flex to form part of a tube drag decoupling arrangement in use.

13. A patient interface structure according to claim 11 wherein said lateral side arms is constructed and arranged to extend along a side of a patient'"'"'s face adjacent a cheek region in use.

14. A patient interface structure according to claim 11, wherein the seal-forming structure is removable from the flexible base portion.

15. A patient interface structure according to claim 11, wherein the seal-forming structure comprises nasal pillows.

16. A patient interface structure according to claim 11, wherein the seal-forming structure comprises nasal prongs.

17. A patient interface structure according to claim 11, wherein the flexible base portion is structured and arranged to align the seal forming structure at an alar angle in use.

18. A patient interface structure according to claim 11, wherein the seal-forming structure is integrally formed in one piece with the flexible base portion.

19. A patient interface structure according to claim 18, wherein the seal-forming structure and the flexible base portion are molded.

20. A patient interface structure according to claim 11, wherein the flexible base portion is formed of a material having a durometer of about 20 to 60 on the Shore A scale.

21. A patient interface structure according to claim 11, wherein the flexible base portion comprises an aperture for introduction of the supply of air, the aperture having an axis that is substantially parallel to an axis of the seal-forming portion.

22. A patient interface structure according to claim 11, wherein the patient interface structure does not comprise any rigid components.

23. A patient interface structure according to claim 11, wherein the flexible base portion does not comprise a vent in the flexible plenum.

117. A mask system for delivering a flow of pressurized breathable gas to a patient, the mask system comprising:

a patient interface structure according to claim 11; and

a headgear connected to the patient interface structure to hold the patient interface structure in sealing engagement with the patient'"'"'s face, wherein the headgear comprises a plurality of straps.

118. A mask system according to claim 117, wherein the plurality of straps comprises first and second side straps, each side strap configured to extend over a temple area of the patient, between an eye and an ear, and along the side of the patient'"'"'s face to the corresponding respective first and second lateral side arms of the patient interface structure.

119. The mask system of claim 117 wherein the plurality of straps further comprises a top strap configured to extend across the top of the patient'"'"'s head, and a rear strap configured to extend around the back of the patient'"'"'s head.

120. A mask system according to claim 119, wherein the side straps and the top strap are formed from a single sheet of flexible material.

121. A mask system according to claim 120, wherein the side straps and the top strap are molded from silicone.

122. A mask system according to claim 121, wherein the side straps and the top strap have rounded edges having a radius of greater than about 0.5 mm.

123. A mask system according to claim 119, wherein the rear strap is formed of a laminate of compressed foam and fabric material.

124. A mask system according to claim 117, wherein the headgear further comprises a pair of stiffening elements, each stiffening element being connected to a respective side strap.

125. A mask system according to claim 124, wherein each stiffening element is formed to be sufficiently rigid along its longitudinal length to resist bending under headgear tension forces, but able to conform in an out of plane direction to lie flat on the patient'"'"'s face.

126. A mask system according to claim 124, wherein each stiffening element is threaded through, adhered, or stitched to its respective side strap.

127. A mask system according to claim 124, wherein each stiffening element is supported on a side strap such that a position of the stiffening element with respect to the side strap is adjustable.

128. A mask system according to claim 124, wherein each stiffening element is configured to traverse an eye socket of the patient.

129. A mask system according to claim 124, wherein the stiffening element material is nylon, polypropylene or silicone.

130. A mask system according to claim 117, further comprising a strap connector at each junction of the side straps, the top strap and the rear strap, each strap connector configured to permit angular and/or lateral adjustment of each side strap with respect to the rear strap.

131. As mask system according to claim 118, further comprising a connector adapted to interconnect a lateral side arm of the patient interface structure and a side strap of the headgear in use.

132. A mask system according to claim 131, wherein each lateral side arm comprises a first side arm connector and a second side arm connector.

133. A mask system according to claim 132, wherein the first side arm connector is configured to connect to an upper portion of the patient interface structure and the second side arm connector is configured to connect to a lower portion of the patient interface structure.

134. A mask system according to claim 132, wherein the first side arm connector is longer than the second side arm connector.

135. A mask system according to claim 132, wherein the first side arm connector is shorter than the second side arm connector.

140. A mask system according to claim 117, further comprising a decoupling element configured to connect the patient interface structure to a delivery hose or an elbow and decouple movement of the elbow or the delivery hose from the patient interface structure.

141. A mask system according to claim 140, wherein the decoupling element is configured to permit relative rotation of the delivery hose or elbow with respect to the patient interface structure on more than one axis of rotation.

142. A mask system according to claim 140, wherein the decoupling element comprises a swivel ring, a ball and socket arrangement, a universal joint, a hinge, and/or a diaphragm having a flat, wave-shaped, or concertina configuration.

24. A patient interface system for delivery of a supply of air at positive pressure to the entrance of a patient'"'"'s airways for treatment of sleep disordered breathing, comprising:

a headgear assembly to provide a headgear tension force, said headgear assembly constructed and arranged to overlay a cheek region in use;

an air delivery tube adapted to receive a supply of air at positive pressure;

a pair of nasal pillows each having a frusto-cone shaped seal portion adapted to form a seal on an underside of a patient'"'"'s nose in use in an area about a naris and a first decoupling assembly said first decoupling assembly comprising a stalk, a first flexible region on the underside of the frusto-cone shaped seal portion and connected to said stalk and a second flexible region adjacent the base of the stalk; and

a flexible base portion having a top portion to which said pair of nasal pillows is connected and having first and second lateral connectors, each of said lateral connectors being adapted to receive the headgear tension force from said headgear assembly, said flexible base portion having a lower portion adapted for interconnection with said air delivery tube and said lower portion forming a second decoupling assembly.

25. A patient interface system according to claim 24, wherein the flexible base lower portion comprises flexible bellows on lateral sides.

26. A patient interface system according to claim 24, further comprising a swivel or a ball and socket.

27. A patient interface system according to claim 26, further comprising a radial seal.

28. A patient interface system according to claim 24, wherein each of the stalks is adapted to articulate with respect to the corresponding frusto-cone shaped seal portion to assist in maintaining said seal portion in sealing engagement.

29. A patient interface system according to claim 28, wherein the nasal pillows are connected to the flexible base portion by thinned regions of the flexible base portion.

30. A patient interface system according to claims 24, wherein each nasal pillow is adapted to accommodate relative movement of the frusto-cone shaped seal portion and the flexible base portion.

31. A patient interface system according to claim 24, wherein the frusto-cone shaped seal portion of each of the pair of nasal pillows is adapted to rotate at an angle with respect to the stalk of the corresponding nasal pillow.

32. A patient interface system according to claim 24, wherein said headgear assembly comprises a third decoupling assembly wherein said headgear comprises a flexible strap and an end portion of said flexible strap adjacent said lateral connectors is constructed and arranged to stretch in response to a tube drag force.

33. A patient interface system according to claim 32, wherein the flexible strap comprises a flexible forked portion.

34. A patient interface system according to claim 24, wherein the tube comprises a retractable tube.

35. A seal positioning and stabilizing structure for a patient interface structure for delivery of a supply of air at positive pressure to the entrance of a patient'"'"'s airways for treatment of sleep disordered breathing, said sealing positioning and stabilizing structure being arranged in use to direct a tension force to a region adjacent an underside of a patient'"'"'s nose at the entrance of a patient'"'"'s airways to effect a seal therewith, said seal positioning and stabilizing structure comprising:

a flexible moulded strap having a first portion adapted to be positioned adjacent a temple region in use and a second portion adapted to be positioned adjacent a cheek region in use wherein said first portion and said second portion are moulded in one piece to define an angle therebetween in the range of about 150 degrees to about 90 degrees,

said seal positioning and stabilizing structure being moulded to further comprise a stiffened portion located between said first and said second portions,

and said seal positioning and stabilizing structure further comprising a rear strap adapted to pass around a rear of a patient'"'"'s head in use.

36. A seal positioning and stabilizing structure according to claim 35, wherein the strap is molded from silicone having a durometer, wherein said first and second portions are molded from silicone having a durometer of about 60 to 70 on the Shore A scale.

37. A seal positioning and stabilizing structure according to claim 35, wherein the strap first, second and stiffened portions are moulded in one piece.

38. A seal positioning and stabilizing structure according to claim 35, wherein the stiffened portion of the strap is constructed and arranged to lie adjacent a temple region of a face of a patient in use.

39. A seal positioning and stabilizing structure according to claim 35, wherein the stiffened portion of the strap has a thickness in the range of 3 mm to 10 mm.

40. A seal positioning and stabilizing structure according to claim 35, wherein the strap comprises a strap connector portion adapted to engage with a corresponding connector of a patient interface structure, wherein said strap connector portion is moulded in one piece with said strap.

41. A seal positioning and stabilizing structure according to claim 35, further comprising a length adjustment mechanism molded in one piece with the strap.

42. A seal positioning and stabilizing structure according to claim 35, wherein the strap comprises a tapering thickness end.

43. A seal positioning and stabilizing structure according to claim 35, wherein said strap is moulded to have a rounded edge.

44. A seal positioning and stabilizing structure according to claim 43 wherein said rounded edge has a radius of greater than about 0.5 mm.

45. A seal positioning and stabilizing structure according to claim 43, wherein the rounded edge is formed on a patient contacting side of said strap.

46. A seal positioning and stabilizing structure according to claim 35, wherein the seal positioning and stabilizing structure comprises three adjustment points.

47. A seal positioning and stabilizing structure according to claim 35, wherein the strap comprise a forked connection with a patient interface structure.

48. A seal positioning and stabilizing structure according to claim 35, wherein the strap comprises a flexing connection with a patient interface structure.

49. A seal positioning and stabilizing structure according to claim 35, wherein the seal positioning and stabilizing structure does not comprise a separate stiffening member.

50. A seal positioning and stabilizing structure according to claim 35, wherein a rear portion of the strap comprises straight sides.

51-116. -116. (canceled)

143-249. -249. (canceled)

250. A patient interface system for delivery of a supply of air at positive pressure to the entrance of a patient'"'"'s airways for treatment of sleep disordered breathing comprising:

a patient interface structure comprising a seal and a flexible base, the flexible base having a top portion and a lower portion defining a plenum, and wherein the seal is arranged on said top portion;

a seal positioning and stabilizing structure being connected in use to the top portion and arranged to direct a force against the base of the nose in a direction normal to the nares in use;

a vent to permit exhaust of the patient'"'"'s exhalation wherein said vent is arranged to be rigid or semi-rigid; and

an air delivery tube connected to the lower portion of the flexible base of the patient interface structure, the lower portion including a flexible side wall constructed to decouple a tube drag force from the seal and the seal positioning and stabilizing structure.

251. A patient interface structure according to claim 250, wherein the seal comprises nasal pillows.

252. A patient interface structure according to claim 250, wherein the seal comprises nasal prongs.

253. A patient interface structure according to claim 250, wherein the seal comprises a foam cushion.

254. A patient interface structure according to claim 250, wherein the seal comprises a gel cushion.

255. A patient interface structure according to claim 250, wherein the seal comprises a flap cushion.

256. A patient interface system according to claim 250, wherein said patient interface structure is integrally formed.

257. A patient interface system according to claim 250, wherein the flexible base is moulded from silicone.

258. A patient interface system according to claim 250, wherein the flexible base is made from a material having a Shore A durometer in the range of about 20 to about 60.

259. The patient interface system of claim 250 further wherein the seal positioning and stabilizing structure is structured to direct a line of force through the top portion of the patient interface structure.

260. The patient interface system of claim 250 wherein said flexible base comprises an orifice adapted to receive the supply of air, and said orifice is arranged such that when viewed from the side, an axis through the seal is substantially parallel to a normal to the orifice.

261. The patient interface system of claim 250 wherein the air delivery tube is arranged to deliver a supply of air to the lower portion in a direction substantially parallel to an axis through the seal.

262. A patient interface structure according to claim 250, wherein the flexible base comprises lateral bellow regions.

263. A patient interface structure according to claim 262, wherein the flexible base comprises a narrow region intermediate the lateral bellow regions to accommodate the patient'"'"'s top lip and the tip of the patient'"'"'s nose.

264. A patient interface according to claim 250, wherein the seal is removable from the flexible base.

265. A patient interface structure according to claim 250 wherein the vent structure has sufficient rigidity to support its own weight under gravity and/or not to block or fold under tube movement or tube drag.

266. The patient interface according to claim 250 wherein the vent structure is semi-rigid.

267. The patient interface according to claim 250 further comprising an elbow.

268. The patient interface according to claim 267 wherein the vent structure is included in the elbow.

269. The patient interface according to claim 250 wherein the seal positioning and stabilizing structure defines a plane of connection close to the base of the nose in use.

270. The patient interface according to claim 250 wherein in use said force is directed in a direction from the base of the nose towards the eyes.

271. The patient interface system according to claim 250 wherein said force is arranged to effect a seal against an outer surface of a patient'"'"'s nare.

272. The patient interface system according to claim 250 wherein said flexible base is structured to avoid contact with the top lip.

278. A seal positioning and stabilizing structure according to claim 272, wherein the strap comprises a length adjustment mechanism.

279. A seal positioning and stabilizing structure according to claim 278, wherein the length adjustment mechanism is molded with the strap.

280. A seal positioning and stabilizing structure according to claim 278, wherein the strap comprises a tapered end.

273. A seal positioning and stabilizing structure for a patient interface structure for delivery of a supply of air at positive pressure to the entrance of a patient'"'"'s airways for treatment of sleep disordered breathing comprising:

a flexible molded strap having a Shore A durometer in the range of about 40 to about 80 comprising a flexible region and a stiffened region, said strap arranged in use to direct a force to an underside of a patient'"'"'s nose to effect a seal.

274. A seal positioning and stabilizing structure according to claim 273, wherein the strap is molded from silicone having a Shore A durometer in the range of about 60 to about 70.

275. A seal positioning and stabilizing structure according to claim 273 wherein the said flexible region has a thickness less than said stiffened region.

276. A seal positioning and stabilizing structure according to claim 275, wherein said flexible region is arranged to flex around the patient'"'"'s cheeks in use.

277. A seal positioning and stabilizing structure according to claim 275, wherein said stiffened region is arranged to curve over the patient'"'"'s temples in use.

281. A seal positioning and stabilizing structure according to claim 273, wherein a first end of the strap and a second end of the strap define an angle of about 150°

to about 90°

.

282. A seal positioning and stabilizing structure according to any one of claim 273, further comprising a second strap.

283. A seal positioning and stabilizing structure according to claim 282, wherein an angle between a first end of the strap and the second strap is about 90°

to about 140°

.

284. A seal positioning and stabilizing structure according to claim 273, wherein the seal positioning and stabilizing structure comprises three adjustment points.

285. A seal positioning and stabilizing structure according to claim 273, wherein the strap comprise a forked connection with a patient interface structure.

286. A seal positioning and stabilizing structure according to claim 273, wherein the strap comprises a flexing connection with the patient interface structure.

287. A seal positioning and stabilizing structure according to claim 273, wherein the seal positioning and stabilizing structure does not comprise a separate stiffening member.

288. A seal positioning and stabilizing structure according to claim 273, wherein a rear portion of the strap comprises straight sides.

289. The seal positioning and stabilising structure according to claim 273 wherein said molded flexible strap is molded from silicone.

290. A patient interface system comprising an air delivery tube and a seal positioning and stabilising structure according to claim 273, wherein the air delivery tube is decoupled from the seal positioning and stabilising structure.

291. The seal positioning and stabilizing structure of claim 273 further comprising left- and right-connectors adapted for interconnection with corresponding respective left and right connectors of a patient interface structure.

292. The seal positioning and stabilizing structure of claim 273 wherein said flexible moulded strap comprises a region having a rounded edge on a patient contacting side.

293. The seal positioning and stabilizing structure of claim 292 wherein said a region having a rounded edge has a radius of greater than about 0.5 mm.

294. The seal positioning and stabilizing structure of claim 273 wherein said flexible moulded strap is translucent.

295. The seal positioning and stabilizing structure of claim 273 wherein said flexible moulded strap is transparent.

296. A patient interface system for delivery of a supply of air at positive pressure to the entrance of a patient'"'"'s airways for treatment of sleep disordered breathing comprising:

a patient interface structure comprising a nasal pillows seal and a flexible base, the flexible base having a first portion and a second portion defining a plenum, and wherein the nasal pillows seal is arranged on said first portion;

a seal positioning and stabilizing structure being connected in use to the first portion and arranged to sealingly locate the nasal pillows seal adjacent the patient'"'"'s nares in use;

a vent to permit exhaust of the patient'"'"'s exhalation wherein said vent is arranged to be rigid or semi-rigid; and

an air delivery tube connected to the second portion of the flexible base of the patient interface structure, the second portion including a flexible side wall constructed to decouple a tube drag force from the seal and the seal positioning and stabilizing structure.

297. A patient interface structure according to claim 296, wherein said nasal pillows seal comprises a a pair of nasal pillows each having a frusto-cone shaped seal portion adapted to form a seal on an underside of a patient'"'"'s nose in use in an area about a naris, a stalk connecting the seal portion to the flexible base, a first flexible region on the underside of the frusto-cone shaped seal portion and connected to said stalk and a second flexible region adjacent the base of the stalk.

298. A patient interface structure according to claim 297, wherein the seal positioning and stabilizing structure comprises patient headgear.

299. A patient interface structure according to claim 298, wherein the connection between the headgear and the first portion of the flexible base is adapted to apply headgear tension across a surface of said first portion.

300. A patient interface structure according to claim 299, wherein said connection is adapted to apply the headgear tension substantially in line with top surface of said first portion.

301. A patient interface structure according to claim 299, wherein the flexible base is adapted to flex about the underside of the patient'"'"'s nose on application of said headgear tension.

302. A patient interface structure according to claim 301, wherein the flexible base is adapted to flex to adopt an alar angle about the underside of the nose upon application of said headgear tension.

303-305. -305. (canceled)