Flexible structure for mask, and method and apparatus for evaluating performance of a mask in use

1. A respiratory mask assembly for delivery of pressurized breathable gas for treatment of sleep disordered breathing, the respiratory mask assembly comprising:

a sealing element; and

headgear structured and arranged to maintain the sealing element in sealing contact with an area surrounding an entrance to a patient's airways, the headgear comprising:

at least one strap adapted to engage a patient's head, the at least one strap structured and arranged to provide a force to effect a seal of the sealing element with the area surrounding the entrance to the patient's airways,

the at least one strap including one or more bladders filled with a gel,

wherein the at least one strap comprises a molded skin of liquid silicone rubber (LSR), the molded skin forming walls of each of the one or more bladders, and

wherein the molded skin includes a head engaging surface with a molded, three-dimensional curvature, the molded, three-dimensional curvature including a pre-formed anatomical shape that is pre-formed before engagement of the head engaging surface with the patient's head, and the molded, three-dimensional curvature of the head engaging surface adapted to substantially match a shape of at least a portion of the patient's head.

2. The respiratory mask assembly according to claim 1 , wherein each of the walls includes a thickness of about 0.3 to 0.6 mm.

3. The respiratory mask assembly according to claim 1 , wherein at least one of the walls includes a thickness that is different than a thickness of another one of the walls.

4. The respiratory mask assembly according to claim 3 , wherein the walls include an inside wall that is thicker than an outside wall.

5. The respiratory mask assembly according to claim 1 , wherein the at least one strap includes a first bladder filled with a first gel and a second bladder filled with a second gel.

6. The respiratory mask assembly according to claim 5 , wherein the first gel includes a different hardness than the second gel.

7. The respiratory mask assembly according to claim 5 , wherein the first gel includes a different density than the second gel.

8. The respiratory mask assembly according to claim 1 , wherein the at least one strap includes a bladder that extends along a portion of a length of the at least one strap.

9. The respiratory mask assembly according to claim 8 , wherein the bladder extends along substantially an entire length of the at least one strap.

10. The respiratory mask assembly according to claim 8 , wherein the bladder extends across substantially an entire width of the at least one strap.

11. The respiratory mask assembly according to claim 1 , wherein the at least one strap includes at least a first bladder and a second bladder, the first bladder and the second bladder extending across a width of the at least one strap.

12. The respiratory mask assembly according to claim 11 , wherein the first and second bladders are provided along edges of the at least one strap.

13. The respiratory mask assembly according to claim 12 , wherein the at least one strap includes an intermediate section between the first and second bladders, the intermediate section including a reduced thickness with respect to the first and second bladders.

14. The respiratory mask assembly according claim 11 , wherein the first and second bladders include different lengths along a length of the at least one strap.

15. The respiratory mask assembly according to claim 1 , wherein the one or more bladders are strategically located along the at least one strap and structured and arranged to alleviate pressure in one or more specific regions of a patient's head.

16. The respiratory mask assembly according to claim 1 , wherein the head engaging surface is curved or contoured and adapted to closely match a specific region of the patient's head.

17. The respiratory mask assembly according to claim 1 , wherein the molded, three-dimensional curvature of the head engaging surface is continuously maintained before engagement with the patient's head without manual manipulation.

18. The respiratory mask assembly according to claim 1 , wherein the molded, three-dimensional curvature is provided along a head engaging side of the at least one strap adapted to contact the patient's head.

19. The respiratory mask assembly according to claim 1 , wherein the molded, three-dimensional curvature extends across a width of the at least one strap when viewed in cross-section.