Nasal mask system

Abstract

To provide a medical device used for the diagnosis, treatment, or prevention of respiratory diseases that offers improvements in one or more of the following: comfort, cost, effectiveness, ease of use, and manufacturability. [Solution] The mask system includes a cushion for the mask that seals the area of ​​the nose, generally above the tip or nasal tip, in its upper range, and extends over a portion of the cartilaginous framework of the patient's nose, the ala or flank, but does not extend over or across the nasal bone of the patient's nose, for example.

Claims

1. A patient interface that provides positive pressure air supply to the entrance of a patient's airway, wherein the patient interface is (i) A nasal mask having a sealing portion configured and positioned to form a seal to a portion of the patient's upper lip and to form a seal to a portion of the patient's nasal cartilage framework, wherein the nasal mask further has a plenum chamber that receives a portion of the patient's nose, including the nasal tip, during use. (ii) A positioning and stabilizing structure including a pair of side straps that provide two-point connection to the nasal mask, wherein the side straps are configured and arranged to be attached and detached without passing the side straps below the patient's ears, A patient interface equipped with this feature.

2. The patient interface according to claim 1, wherein the positioning and stabilizing structure includes a headgear assembly comprising a pair of lateral straps and a rear strap, the lateral straps being fitted to extend along the sides of the patient's face between the patient's eyes and ears, and the rear strap extending between the lateral straps and being fitted to engage along the posterior or rear region of the patient's head, along the occipital bone, below the occipital bone, or below the occipital bone.

3. The patient interface according to any one of claims 1 to 2, wherein the side strap defines a main headgear loop that is adapted to extend from a lower rear position to an upper front position.

4. The patient interface according to any one of claims 1 to 3, wherein the side straps are configured and arranged to be attached to the patient's head without being pulled down over the patient's ears and to be removed from the patient's head without being pulled up over the patient's ears.

5. The patient interface according to any one of claims 1 to 4, wherein the pair of lateral straps are adapted to pass over the patient's ears.

6. The patient interface according to any one of claims 1 to 5, wherein the pair of side straps are adapted to engage with the respective headgear connectors provided on the nasal mask in order to provide the two-point connection with the nasal mask.

7. The patient interface according to any one of claims 1 to 6, wherein the seal-forming portion is located above the nasal tip and includes a nasal ridge region positioned below the nasal bone region of the patient's nasal ridge and adapted to seal along the nasal cartilage region.

8. The patient interface according to any one of claims 1 to 7, wherein the seal-forming portion is an upper sealing portion, which is located on the portion of the cartilaginous framework of the patient's nose and is configured and positioned to form a seal with the portion of the cartilaginous framework of the patient's nose without providing a sealing force that would restrict the airflow through the nasal cavity.

9. The patient interface according to any one of claims 1 to 8, wherein the seal-forming portion includes a lower sealing portion which is partially located on a portion of the area of ​​the patient's upper lip and is configured and positioned to direct a sealing force toward a portion of the patient's maxilla.

10. The patient interface according to any one of claims 1 to 9, wherein the plenum chamber includes a flexible or semi-rigid wall.

11. The patient interface according to any one of claims 1 to 10, wherein the seal-forming portion is pre-formed or otherwise pre-molded to match the facial topology of the patient.

12. A CPAP system comprising a PAP device that generates air supply at positive pressure, and a patient interface according to any one of claims 1 to 11.

13. The CPAP system according to claim 12, further comprising a humidifier for humidifying the air from the PAP device.

14. A method for fitting the patient interface to the patient, The steps include positioning the sealing region of the patient interface relative to the patient's nose such that the sealing region surrounds both nostrils, The steps include engaging the headgear strap of the patient interface with the patient's head without passing the strap below the patient's ears, Methods that include...

15. The method according to claim 14, further comprising the step of engaging the headgear strap of the patient interface with the patient's head without pulling the strap down over the patient's ears.

16. The method according to claim 14 or 15, further comprising the step of removing the patient interface from the patient's head by removing the headgear strap from the patient's head without pulling the strap up over the patient's ears.

17. The method according to any one of claims 14 to 16, further comprising the step of engaging a headgear strap with the patient's head without interfering with the patient's ears.

18. The method according to any one of claims 14 to 17, wherein the step of positioning the sealing region includes positioning the nasal ridge region of the sealing region along the nasal cartilage region which is above the tip of the nose and below the nasal bone region of the patient's nasal ridge.

19. A cushion assembly including a sealing area that provides a single orifice fitted to surround both nostrils of the patient's nose, A headgear assembly comprising a pair of lateral and posterior straps, wherein the lateral straps extend along the sides of the patient's face between the patient's eyes and ears and are fitted to engage with respective headgear connectors provided on the cushion assembly to provide a two-point connection with the cushion assembly, and the posterior strap extends between the lateral straps and is fitted to engage along the posterior or posterior region of the patient's head, along the occipital bone, below the occipital bone, or below the occipital bone, and the headgear assembly, A nasal mask system equipped with [the following features].

20. The nasal mask system according to claim 19, wherein the side straps are adapted to extend from a lower rear position to an upper front position.

21. A nasal mask for delivering an air supply to the entrance of a patient's airway, comprising an upper sealing portion and a lower sealing portion, wherein the upper sealing portion is configured and positioned to be located on a portion of the nasal cartilage framework and to form a seal with the portion of the nasal cartilage framework without providing a sealing force that would restrict the airflow through the nasal cavity, A nasal mask system in which the lower sealing portion is configured and positioned so as to be partially located on a portion of the patient's upper lip and so as to direct the sealing force toward a portion of the patient's maxilla.

22. It is a nasal mask system, A cushion assembly comprising a sealing region having a nasal ridge region, a nasal lateral region, a nasal corner region, and an upper lip region, which is fitted to seal around both nasal cavities of the patient's nose, wherein the nasal ridge region is located above the nasal tip and positioned in the nasal cartilage region below the nasal bone region of the patient's nasal ridge, and is fitted to seal along the nasal cartilage region, The nasal mask system comprises a sealing membrane extending around the entire periphery of the sealing region and an undercushion provided only within the upper lip and nasal corner region.

23. The nasal mask system according to claim 22, wherein the membrane and under cushion provide a compression seal in the upper lip and nasal corner region.

24. The nasal mask system according to any one of claims 22 to 23, wherein in the nasal ridge and lateral nasal region, the membrane is configured and positioned to be under tension during use, and / or the pressure within the breathing chamber provided by the cushion assembly acts on the membrane to provide a seal.

25. It is a nasal mask system, The cushion assembly includes a sealing region adapted to seal around both nostrils of the patient's nose, an attachment region adapted to receive a bending assembly, and a side wall region extending between the sealing region and the attachment region. The sealing region includes a nasal bridge region, a nasal side region, a nasal corner region, and an upper lip region. A nasal mask system comprising an area adjacent to the upper lip region of the sealing region, wherein the side wall region includes a thickness thinner than the corresponding thickness adjacent to the nasal ridge, nasal side, and nasal corner regions of the sealing region.

26. The nasal mask system according to claim 25, wherein the area provides relatively greater pressure along the nasal corner region to avoid excessive pressure on the columella of the patient's nose.

27. It is a nasal mask system, The cushion assembly includes a sealing region having a nasal ridge region, a nasal side region, a nasal corner region, and an upper lip region, which are fitted to seal around both nostrils of the patient's nose. The nasal lateral region includes a portion that is positioned along the region adjacent to the junction between the greater alar cartilage and the lateral nasal cartilage of the patient's nose and is adapted to seal, a nasal mask system.

28. The nasal mask system according to claim 27, wherein the sealing region includes a membrane seal extending around the entire periphery of the sealing region, and the portion includes wings or sealing flaps projecting from the edges of the membrane along its inner circumference.

29. The nasal mask system according to claim 28, wherein the wing or sealing flap is at least partially angled away from or pre-biased from the breathing chamber provided by the cushion assembly.

30. A nasal mask that defines a breathing chamber for delivering a gas supply to a patient's airway under positive pressure, wherein the nasal mask is A vent adapted to expel breathable gas, wherein the vent is adapted to be rigid enough to avoid collapsing, A cushion including a sealing cuff and headgear connector, Equipped with, The sealing cuff comprises a membrane seal and an under cushion, Furthermore, the membrane seal extends around the periphery of the cushion, including the nasal ridge region and the nasal side region of the cushion, and the under cushion is located in the upper lip region of the cushion and does not extend to the nasal ridge region or the nasal side region of the cushion. The headgear connector is a nose mask formed by the side walls of the cushion.

31. The nasal mask according to claim 30, wherein the nasal bridge region of the sealing cuff seals in its upper range within the nasal region generally above the tip of the nose.

32. The nasal lateral region of the cushion extends over the ala or spread of the patient's nose, according to claim 30 or 31.

33. The nasal mask according to any one of claims 30 to 32, wherein the cushion does not extend over or across the nasal bone of the patient.

34. A nasal mask according to any one of claims 30 to 33, which lacks a rigid frame.

35. A nasal mask according to any one of claims 30 to 34, which lacks forehead support.

36. A nasal mask according to any one of claims 30 to 35, comprising two headgear connectors.

37. The nasal mask according to any one of claims 30 to 36, wherein the headgear connectors are located on opposite sides of the side wall.

38. The nasal mask according to any one of claims 30 to 37, wherein the vent is located in the bent portion assembly.

39. The nasal mask according to any one of claims 30 to 37, wherein the ventilation opening is located in the cushion.

40. The nasal mask according to any one of claims 30 to 39, wherein the cushion further comprises a nasal corner region, the nasal corner region having a higher sealing force compared to the nasal ridge region.

41. The nasal mask according to any one of claims 30 to 40, wherein the headgear connector is positioned at an angle α with respect to the vertical axis of the sealing cuff.

42. The nose mask according to claim 41, wherein the angle α is 90 to 100°.

43. The nasal mask according to any one of claims 30 to 42, wherein the headgear connector is positioned at an angle β with respect to the horizontal axis of the sealing cuff.

44. The nose mask according to claim 43, wherein the angle β is 90 to 100°.

45. The nasal mask according to any one of claims 30 to 44, wherein the headgear connector has a first width in a region adjacent to the side wall and a second width at its tip, the first width being greater than the second width.

46. The nose mask according to claim 45, wherein the first width is 20 to 25 mm.

47. The nose mask according to claim 45, wherein the second width is 15 to 20 mm.

48. A patient interface that provides positive pressure air supply to the entrance of a patient's airway, wherein the patient interface is (i) A nasal mask having a sealing portion configured and positioned to form a seal on a portion of the patient's upper lip and on a portion of the cartilaginous framework of the patient's nose, wherein the nasal mask further has a plenum chamber that receives a portion of the patient's nose, including the nasal tip, during use. (ii) A positioning and stabilization structure that provides a ceiling vector directed at a certain angle with respect to the horizontal direction of Frankfurt, Equipped with, The positioning and stabilization structure includes a two-point connection to the nasal mask, and is a patient interface. Face.

49. A patient interface that provides positive pressure air supply to the entrance of a patient's airway, wherein the patient interface is (i) A nasal mask having a sealing portion configured and positioned to form a seal to a portion of the patient's upper lip and to form a seal to a portion of the patient's nasal cartilage framework, wherein the nasal mask further has a plenum chamber that receives a portion of the patient's nose, including the nasal tip, during use. (ii) A positioning and stabilization structure that provides a ceiling vector directed at a certain angle with respect to the horizontal direction of Frankfurt, Equipped with, The aforementioned nasal mask is a patient interface that does not include forehead support.

50. A patient interface that provides positive pressure air supply to the entrance of a patient's airway, wherein the patient interface is (i) A nasal mask having a sealing portion configured and positioned to form a seal to a portion of the patient's upper lip and to form a seal to a portion of the patient's nasal cartilage framework, wherein the nasal mask further has a plenum chamber that receives a portion of the patient's nose, including the nasal tip, during use. (ii) A positioning and stabilization structure that provides a ceiling vector directed at a certain angle with respect to the horizontal direction of Frankfurt, Equipped with, The positioning and stabilization structure includes a patient interface comprising a pair of lateral straps adapted to extend toward and over the top of the patient's head.

51. The patient interface according to claim 50, wherein the lateral strap covers a portion of the parietal bone.

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