FACIAL MASK AND METHOD OF MAKING

• US 20150273170A1
• Filed: 06/10/2015
• Published: 10/01/2015
• Est. Priority Date: 03/10/2014
• Status: Active Grant

• Current Assignee: Morpheus Medical Solutions, LLC
• Original Assignee: Morpheus Medical Solutions, LLC
• Inventors: Bachelder, Vance D., Carrillo, Jose III
• Granted Patent: US 10,463,823 B2
• Time in Patent Office: Days
• US Class Current: 1/1
• CPC Class Codes: A61M 16/0605 Means for improving the adaptation of the mask to the patient
• CPC Class Codes: A61M 16/0611 with a gusset portion
• CPC Class Codes: A61M 16/0616 with face sealing means comprising a flap or membrane projecting inwards, such that sealing increases with increasing inhalation gas pressure
• CPC Class Codes: A61M 16/0672 Nasal cannula assemblies for oxygen therapy
• CPC Class Codes: A61M 2016/0661 with customised shape
• CPC Class Codes: A61M 2202/0208 Oxygen
• CPC Class Codes: A61M 2202/0283 Nitrous oxide (N2O)
• CPC Class Codes: A61M 2207/00 Methods of manufacture, assembly or production
• CPC Class Codes: B29L 2031/4835 Masks
• CPC Class Codes: B29L 2031/507 Insoles
• CPC Class Codes: B29L 2031/753 Medical equipment; Accessories therefor bloodbags, medical bags B29L2031/7148; artificial eyes B29L2011/0008
• CPC Class Codes: B33Y 10/00 Processes of additive manufacturing
• CPC Class Codes: B33Y 80/00 Products made by additive manufacturing

Abstract

Masks for various uses and methods for manufacture thereof, including masks for use in continuous positive air pressure (CPAP) therapies. An example includes a mask having a first, relatively softer material for contact with the face of the user, and a second, relatively harder or more structural material used away from the face of the user, with a gradient therebetween. The mask can be produced by additive manufacturing to avoid a discernible boundary between the first and second materials. The mask may include a foam element, which can be removable for replacement in some examples, for contacting the patient'"'"'s skin.

Claims

1. A facial mask comprising a first material and a second material and a material gradient in at least a portion of the mask, the material gradient transitioning from the first material to the second material, and a foam layer covering at least a portion of the second material in a region adapted for contact with the skin of a patient.

2. The facial mask of claim 1 wherein the first material is a polymeric material suited to a first purpose, and the second material is a polymeric material suited to a second purpose and not to the first purpose, and the foam layer is a polyurethane foam.

3. The facial mask of claim 2 wherein the first material is a relatively softer material well suited to contact with the face of a patient, and the second material is a harder material well suited to providing a structure and shape to the mask.

4. The facial mask of claim 1 wherein the foam layer is removable over the second material.

5. The facial mask of claim 4 wherein the second material includes a portion in the form of a foot and the foam layer includes a generally C-shaped area configured to elastically expand and receive the foot.

6. The facial mask of claim 1 wherein the mask is a CPAP mask.

7. The facial mask of claim 1 wherein the mask is made by additive manufacturing without the use of insert molding or casting.

8. The facial mask of claim 1 wherein the material gradient is characterized by a lack of discernable boundary insofar as there is no visible boundary to the naked eye.

9. The facial mask of claim 1 wherein the material gradient is characterized by a lack of discernable boundary insofar as a boundary cannot be identified under manual inspection.

10. A method of manufacturing a facial mask, the method comprising:

obtaining a set of facial contours of a person'"'"'s face by one or more of digital photography, video, infrared, or laser scanning;

optimizing a set of mask contours for an area where a mask will come in contact with the person'"'"'s face; and

constructing a mask using an additive printing process including a first layer of a first material having first properties and a second layer of a second material having second properties and a material gradient between the first and second layers in at least a portion of the mask, the material gradient characterized by the lack of a discernable boundary between the first and second materials.

11. The method of claim 10 wherein the constructing step is performed such that the first material is a polymeric material suited to a first purpose, and the second material is a polymeric material suited to a second purpose and not to the first purpose.

12. The method of claim 11 wherein the constructing step is performed such that the first material is a relatively softer material well suited to contact with the face of a patient, and the second material is a harder material well suited to providing a structure and shape to the mask.

13. The method of claim 12 wherein the constructing step is performed by introducing a third material having third material properties different from each of the first and second materials and joining the third material to at least one of the first and second materials using at least a second gradient characterized by a lack of discernable boundary to the first and/or second materials.

14. The method of claim 10 wherein the constructing step is performed using first and second materials that differ in one or more of modulus, elasticity, glass transition temperature, degree of crystallinity, ductility, softening point, or melt flow index.

15. The method of claim 10 wherein the constructing step is performed without the use of insert molding or casting.

16. The method of claim 10 wherein the additive process is performed such that the material gradient is characterized by a lack of discernable boundary from the first material to the second material insofar as there is no visible boundary to the naked eye from the first material to the second material.

17. The method of claim 10 wherein the additive process is performed such that the material gradient is characterized by a lack of discernable boundary from the first material to the second material insofar as a boundary cannot be identified under manual inspection.

18. The method of claim 10 wherein the step of optimizing a set of mask contours comprises identifying one or more fiducial points of the set of facial contours associated with one or more of the patient'"'"'s nose, lips, or eyes and setting an inner boundary and an outer boundary relative to the identified fiducial point or points.

19. A continuous positive air pressure facial mask for the treatment of sleep apnea built according to the method of claim 10.

20. A apparatus for assisting in the breathing of a patient built according to the method of claim 10.