Facial mask and method of making

• US 10,463,823 B2
• Filed: 06/10/2015
• Issued: 11/05/2019
• 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, III, Jose
• Primary Examiner(s): Ho, Tan-Uyen T
• Assistant Examiner(s): Luarca, Margaret M
• Application Number:
  US14/735,928
• Publication Number:
  US 20150273170A1
• Time in Patent Office: 1,609 Days
• 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 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 applying a first layer of a first material having first properties and applying a second layer of a second material having second properties and applying a first material gradient between the first and second layers in at least a portion of the mask, such that the first material is deposited in a first layer, and the second material is deposited in a second layer, with blends of the first and second materials deposited in intermediate layers, the intermediate layers providing the first material gradient, further wherein the first material gradient is characterized by the lack of a discernable boundary between the first and second materials and comprises a blend of the first and second materials;

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;

further wherein the blends of the first and second materials are formed prior to deposition according to mixing ratios, and the method comprises adjusting the mixing ratios as the intermediate layers are deposited;

further wherein the constructing step comprises applying layers of material to form a mask having a first zone shaped to place over the bridge of the person'"'"'s nose, and a second zone shaped to place over the nostrils and/or mouth of the person, with a second material gradient therebetween, wherein the second material gradient provides a transition between the first zone and the second zone in which the first zone comprises a core skeleton element, the second zone omits the core skeleton element, and the second gradient transitions from inclusion of the core skeleton element at the first zone to absence of the core skeleton element in the second zone.

2. The method of claim 1 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.

3. The method of claim 1 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 third material gradient characterized by a lack of discernable boundary to the first and/or second materials.

4. The method of claim 1 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.

5. The method of claim 1 wherein the constructing step is performed without the use of insert molding or casting.

6. The method of claim 1 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.

7. The method of claim 1 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.

8. The method of claim 1 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.

9. A continuous positive air pressure facial mask for the treatment of sleep apnea built according to the method of claim 1.

10. A apparatus for assisting in the breathing of a patient built according to the method of claim 1.