Customized respiratory mask and method of manufacturing same

Data processing: generic control systems or specific application – Specific application – apparatus or process – Product assembly or manufacturing

Reexamination Certificate

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Details

C700S163000, C700S195000, C128S206210

Reexamination Certificate

active

06728589

ABSTRACT:

BACKGROUND OF THE INVENTION
1. Field of the Invention
The present invention relates generally to the field of respiratory masks.
2. Description of the Background Art
A respiratory mask is a device used to deliver a gas or gases to a person. In its simplest form, the respiratory mask includes a shell, an attaching means, and a gas supply hose. The respiratory mask may be used to deliver any variety of gases, including air or oxygen, and a variety of medicines or treatments.
The shell is fitted over a nose portion of the face of the person in order to supply a gas to a respiratory system of the person. Preferably, the shell does not allow a supplied gas to escape. A strap or other attaching means may be fitted over the head of the person. Constant pressure gas is therefore delivered, with the mask also including an exhalation hole whereby a constant pressure is maintained in the mask. This is referred to as a continuous positive airway pressure (CPAP) mask. The exhalation hole allows the patient to exhale without a pressure buildup in the mask.
Related art respiratory masks are commonly made in several standard sizes. They are commonly fitted and chosen by trying on several standard mask sizes and shapes. The potential wearer may find a comfortable fit if he or she happens to be close to a standard size and shape. The related art mask, however, as a matter of economy is designed to only accommodate standard facial types.
The standard respiratory mask of the related art has several drawbacks. First, the related art respiratory mask shell may form a poor seal with the face of the person, since it only conforms to standard sizes and shapes. Leakage of the supplied gas may be critical in applications where a specific amount of gas must be measured and delivered. Second, the related art respiratory mask shell may not accommodate differences in the shape or size of features, causing a painful or uncomfortable fit. This may include undesirable pressure points. Third, a related art respiratory mask respiratory mask shell, due to a poor fit, may not stay in place, and may shift or move.
Related art masks have attempted to solve these drawbacks by creating customized masks made exclusively for a particular subject. This involves taking an impression of the subject's face. The impression may be used to create a mold from which a custom mask may be made. However, creating an impression in some sort of moldable material involves pressing the material against the subject's face. Aside from problems in breathing, problems arise with comfort, convenience, skin irritation, and irritating or noxious vapors. In addition, such a material must be flexible and pliant, and this may allow the impression to become distorted if proper care is not taken during the process.
Therefore, there remains a need in the art for an improved respiratory mask.
SUMMARY OF THE INVENTION
An apparatus for making a customized respiratory mask without contacting a facial area of the subject is provided according to a first aspect of the invention. The apparatus comprises an image capturing means for capturing an image of the facial area as a three-dimensional representation without contacting a facial area of the subject, a cutting machine, and at least one computer capable of receiving the three-dimensional representation of the image and storing the three-dimensional representation in an associated memory, and is further capable of converting the three-dimensional representation into a set of commands and controlling the cutting machine using the set of commands to cut a mask blank to form the customized respiratory mask.
A computer-implemented method for making a customized respiratory mask for a subject without contacting a facial area of said subject is provided according to a second aspect of the invention. The method comprises the steps of capturing an image of the facial area without contacting a facial area of the subject, converting the image into a three-dimensional representation of the facial area, and controlling a cutting machine to cut a respiratory mask blank part to substantially copy the three-dimensional representation, wherein a computer controls the capturing, converting, and controlling steps to create the customized respiratory mask to substantially conform to the facial area of the subject.
The above and other features and advantages of the present invention will be further understood from the following description of the preferred embodiment thereof, taken in conjunction with the accompanying drawings.


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