Patent Description:
The present invention pertains to methods for identifying a custom mask for a patient for use in receiving a flow of a treatment gas to the airway of the patient. The present invention also pertains to systems for carrying out such methods.

Many individuals suffer from disordered breathing during sleep. Sleep apnea is a common example of such sleep disordered breathing suffered by millions of people throughout the world. One type of sleep apnea is obstructive sleep apnea (OSA), which is a condition in which sleep is repeatedly interrupted by an inability to breathe due to an obstruction of the airway; typically the upper airway or pharyngeal area. Obstruction of the airway is generally believed to be due, at least in part, to a general relaxation of the muscles which stabilize the upper airway segment, thereby allowing the tissues to collapse the airway. Another type of sleep apnea syndrome is a central apnea, which is a cessation of respiration due to the absence of respiratory signals from the brain's respiratory center. An apnea condition, whether obstructive, central, or mixed, which is a combination of obstructive and central, is defined as the complete or near cessation of breathing, for example a <NUM>% or greater reduction in peak respiratory air-flow.

Those afflicted with sleep apnea experience sleep fragmentation and complete or nearly complete cessation of ventilation intermittently during sleep with potentially severe degrees of oxyhemoglobin desaturation. These symptoms may be translated clinically into extreme daytime sleepiness, cardiac arrhythmias, pulmonary-artery hypertension, congestive heart failure and/or cognitive dysfunction. Other consequences of sleep apnea include right ventricular dysfunction, carbon dioxide retention during wakefulness, as well as during sleep, and continuous reduced arterial oxygen tension. Sleep apnea sufferers may be at risk for excessive mortality from these factors as well as by an elevated risk for accidents while driving and/or operating potentially dangerous equipment.

Even if a patient does not suffer from a complete or nearly complete obstruction of the airway, it is also known that adverse effects, such as arousals from sleep, can occur where there is only a partial obstruction of the airway. Partial obstruction of the airway typically results in shallow breathing referred to as a hypopnea. A hypopnea is typically defined as a <NUM>% or greater reduction in the peak respiratory air-flow. Other types of sleep disordered breathing include, without limitation, upper airway resistance syndrome (UARS) and vibration of the airway, such as vibration of the pharyngeal wall, commonly referred to as snoring.

It is well known to treat sleep disordered breathing by applying a continuous positive air pressure (CPAP) to the patient's airway. This positive pressure effectively "splints" the airway, thereby maintaining an open passage to the lungs. It is also known to provide a positive pressure therapy in which the pressure of gas delivered to the patient varies with the patient's breathing cycle, or varies with the patient's breathing effort, to increase the comfort to the patient. This pressure support technique is referred to as bi-level pressure support, in which the inspiratory positive airway pressure (IPAP) delivered to the patient is higher than the expiratory positive airway pressure (EPAP). It is further known to provide a positive pressure therapy in which the pressure is automatically adjusted based on the detected conditions of the patient, such as whether the patient is experiencing an apnea and/or hypopnea. This pressure support technique is referred to as an auto-titration type of pressure support, because the pressure support device seeks to provide a pressure to the patient that is only as high as necessary to treat the disordered breathing.

Pressure support therapies as just described involve the placement of a patient interface device including a mask component having a soft, flexible sealing cushion on the face of the patient. The mask component may be, without limitation, a nasal mask that covers the patient's nose, a nasal/oral mask that covers the patient's nose and mouth, or a full face mask that covers the patient's face. Such patient interface devices may also employ other patient contacting components, such as forehead supports, cheek pads and chin pads. The patient interface device is typically secured to the patient's head by a headgear component. The patient interface device is connected to a gas delivery tube or conduit and interfaces the pressure support device with the airway of the patient, so that a flow of breathing gas can be delivered from the pressure/flow generating device to the airway of the patient.

Current state-of-the-art systems for creating a "custom" mask for a patient for use in delivering a flow of a treatment gas to the patient use a single <NUM>-dimensional (<NUM>-D) scan as input to create a spatial model, which is set as a reference for creating the custom mask. An example of such a <NUM>-D scan <NUM> of the face of a patient is shown in <FIG>. In such systems, the user is subjected to a neutral face expression during image acquisition from which the possible face geometry is extracted by determining the location of a plurality of facial landmarks or points (labeled A-W) for mask design. However, such approach fails, as variations in the user's facial geometry in unconstrained poses are not considered during such a neutral scan acquisition. Accordingly, the generated mask does not accommodate to the variations in face geometry resulting from movement of the patient's face, which then becomes a problem with comfort and stability. More particularly, face variations which would commonly occur during sleep are not assessed in such <NUM>-D scans, which makes the custom mask creation more difficult to accommodate the user's actual unconstrained facial geometry. <CIT> discloses a mask shape determination assistance system involving the analysis of images of the patient's face from a laser imaging device and an ultrasonic wave imaging device, wherein an individual face model and deformed face models are obtained. <CIT> discloses a system with a face scanning unit structured to generate <NUM>-D models of a patient's face, a compilation unit structured to receive multiple such different <NUM>-D models and correlate them to generate additional information on the patient's face, and an output unit structured to output this additional information for use, e.g., in algorithms that determine the fit between a patient interface and the patient so as to accurately optimize the fit of a patient interface to a patient, or for selecting, adjusting or customizing a patient interface that optimally fits the patient, wherein the <NUM>-D models include models of the patient's face in different expressions such as smiling. <CIT> discloses a patient interface customization method involving the processing of multiple photos or videos of a patient's head and face to generate a <NUM>-D model of the patient's head and face. <CIT> discloses methods and systems for providing interface components for respiratory therapy, including the generation of a <NUM>-D representation of the user's face based on video and data files generated on the basis of received image data and received movement data. <CIT> discloses a system and method for selecting a respirator. <CIT> discloses a system, method, and an apparatus for generating a three-dimensional representation from one or more two-dimensional images. <CIT> discloses a method for evaluating the performance of a product using a virtual environment. <CIT> discloses a method and system for creating custom, user-specific eyewear.

According to the invention, there is provided a method according to claim <NUM> and a system according to claim <NUM>. The dependent claims define embodiments of the invention.

As one aspect of the invention a method for identifying a mask for a patient according to claim <NUM> is provided.

Identifying the mask to the patient may comprise providing the patient with a specification of the mask or may comprise providing the patient with the mask.

Receiving a plurality of images may comprise receiving a plurality of <NUM>-D images of the patient's face and analyzing the plurality of images may comprise generating the temporal model from the plurality of <NUM>-D images. The plurality of <NUM>-D images may comprise a sequence of <NUM>-D images captured over time. Analyzing the plurality of images may comprise: determining an expected range of facial geometries expressed by the patient's face; registering the range of facial geometries to create the temporal model; and determining an operating range of facial dimensions of the patient, wherein determining the appropriate mask for the patient based on the analysis of the plurality of <NUM>-D images comprises determining an appropriate mask for the patient based on the operating range of facial dimensions. Determining an expected range of facial geometries expressed by the patient's face may comprise determining the positions of a plurality of facial landmarks in the <NUM>-D images.

Receiving a plurality of <NUM>-D images of the patient's face comprises capturing the plurality of <NUM>-D images with a <NUM>-D scanning device.

The plurality of <NUM>-D images may comprise one or more of the patient's face in a plurality of predetermined poses, the patient's face in a plurality of natural poses, and the patient's face in a plurality of differing expressions.

The temporal model may comprise a range of facial dimensions and geometries of the patient's face and determining a mask for the patient may comprise comparing the range of facial dimensions and geometries to establish an operating range of masks.

Receiving a plurality of images may comprise receiving one or more <NUM>-D images of the patient's face and a plurality of <NUM>-D images of the patient's face. Analyzing the plurality of images may comprise: generating a <NUM>-D spatial model of the patient's face by analyzing the one or more <NUM>-D images; and generating the temporal model of the patient's face by registering the plurality of <NUM>-D images to the <NUM>-D spatial model. The plurality of <NUM>-D images may comprise the patient's face in one or more of: a plurality of predetermined poses, a plurality of natural poses, and a plurality of differing expressions. The method may further comprise: extracting information from the plurality of <NUM>-D images, the information including at least one: of landmarks, orientation, and features; and refining the generated <NUM>-D spatial model using the extracted information.

Receiving a plurality of images may comprise receiving a plurality of <NUM>-D images of the patient's face. Analyzing the plurality of images comprises: generating a plurality of <NUM>-D models from the plurality of <NUM>-D images by using standard photogrammetric techniques or disparity maps; and generating the temporal model of the patient's face by registering the <NUM>-D models. The plurality of <NUM>-D images include images of the patient's face in one or more of: a plurality of predetermined poses, a plurality of natural poses, and a plurality of differing expressions.

Receiving a plurality of images comprises receiving a plurality of <NUM>-D images of the patient's face which each contain a reference object of known size and analyzing the plurality of images may comprise generating the temporal model of the patient's face using the plurality of <NUM>-D images.

Receiving a plurality of images comprises receiving a plurality of <NUM>-D images of the patient's face, wherein each <NUM>-D image was captured with a known distance between a device used to capture the <NUM>-D image and the patient's face; and wherein analyzing the plurality of images may comprise generating the spatial and temporal models of the patient's face using the plurality of <NUM>-D images.

As another aspect of the present invention, a system for identifying a mask for a patient according to claim <NUM> is provided. The output device may comprise a <NUM>-D printer.

The system may further comprise an image capturing device in communication with the processing unit, the image capturing device structured to capture the plurality of images of the patient's face. The image capturing device may comprise a <NUM>-D scanner.

Therefore, specific structural and functional details disclosed herein are not to be interpreted as limiting the scope of the invention as defined by the claims, but merely as a basis for the claims and as a representative basis for teaching one skilled in the art to variously employ the present invention in virtually any appropriately detailed structure.

As used herein, the singular form of "a", "an", and "the" include plural references unless the context clearly dictates otherwise. As used herein, the statement that two or more parts or components are "coupled" shall mean that the parts are joined or operate together either directly or indirectly, i.e., through one or more intermediate parts or components, so long as a link occurs. As used herein, "directly coupled" means that two elements are directly in contact with each other. As used herein, "fixedly coupled" or "fixed" means that two components are coupled so as to move as one while maintaining a constant orientation relative to each other.

As used herein, the word "unitary" means a component is created as a single piece or unit. That is, a component that includes pieces that are created separately and then coupled together as a unit is not a "unitary" component or body. As used herein, the statement that two or more parts or components "engage" one another shall mean that the parts exert a force against one another either directly or through one or more intermediate parts or components. As used herein, the term "number" shall mean one or an integer greater than one (i.e., a plurality).

As used herein, the term "facial landmark" shall refer to particular points on a human face associated with elements of the face. Examples of facial landmarks may include, without limitation, a point at the tip of the nose; points at edges of the eyes or mouth, etc..

As used herein, the term "temporal model" shall refer to a numeric representation of an object which includes both three dimensional information as well as time-based variations thereof. For example, a temporal model of a face includes information regarding positioning of facial landmarks, surface geometry and texture of the face, both with respect to a fixed point as well as relative to other facial landmarks, geometry, or both. As used herein, the term "image" shall refer to a representation of the form of a person or thing. Such representation may be a reproduction of the form or may be in the form of electronic information describing the form.

As used herein, the term "<NUM>-D image" shall refer to a two-dimensional representation of the form of a person or thing, whether in electronic form (e.g., such as stored in digital memory) or in visible form (e.g., displayed via an electronic display). A <NUM>-D image may be captured of a physical object by using a digital camera or <NUM>-D scanning device. As used herein, the term "<NUM>-D image" shall refer to a three-dimensional representation of the form of a person or thing, whether in electronic form (e.g., such as stored in digital memory) or in visible form (e.g., displayed via a holographic projector). A <NUM>-D image may be captured of a physical object by using a <NUM>-D scanning device.

As used herein, the term "image registration", also referred to as "registering" is the process of aligning two or more images of the same scene. This process involves designating one image as the reference image, also called the fixed image, and applying geometric transformations or local displacements to the other images so that they align with the reference. By applying image registration to a series of <NUM>-D images, time based changes to the <NUM>-D images are readily obtained for use in a temporal model (i.e., a <NUM>-D model also having information regarding changes occurring over time).

In overcoming shortcomings of prior art approaches which utilize a single <NUM>-D or <NUM>-D image for creating "custom mask", embodiments of the present invention utilize series of expressions (i.e. multiple <NUM>-D or <NUM>-D images) to generate a temporal model of the patient's face that includes not only <NUM>-D spatial information but also time-based information in regards there to. With such temporal information, a wide operating range of facial geometries is determined which can then be utilized for designing a custom mask, or selecting a pre-made mask from amongst a plurality of masks, which provides maximum comfort and stability for the patient. Additionally, time-based analysis (e.g., velocity/acceleration of facial landmarks) can indicate the nature of facial movement (i.e., was it a conscious or unconscious movement or was it a facial expression) which can be used as a criteria to predict a normal operating range of facial geometry during sleep.

<FIG> is a schematic diagram of a system <NUM> according to an embodiment of the invention as claimed, which may be employed in carrying out methods described herein below. System <NUM> includes an image capturing device <NUM> for capturing images of a patient's face. As will be appreciated from the examples discussed further herein image capturing device <NUM> may be one or more of a digital camera structured to capture <NUM>-D images of an object, a scanner structured to capture <NUM>-D scans of an object, or any other suitable device for capturing <NUM> or <NUM> dimensional images of an object, which in the present matter would be a patient's face. System <NUM> also includes a processing unit <NUM> in communication with image scanning device <NUM> and an output device <NUM> in communication with processing device <NUM>. System <NUM> may also include an input device <NUM> in communication with processing device <NUM> for inputting of information to processing unit <NUM>. Alternately, output device <NUM> may be in the form of a combination input/output device (e.g., without limitation, a touchscreen) for both inputting information to, and receiving information from, processing unit <NUM>.

Processing unit <NUM> includes a processing portion which may be, for example, a microprocessor, a microcontroller or some other suitable processing device, and a memory portion that may be internal to the processing portion or operatively coupled to the processing portion and that provides a storage medium for data and software executable by the processing portion for controlling the operation of system <NUM>.

Processing unit <NUM> includes a processor <NUM>, a memory <NUM>, and a communication unit <NUM>. Processor <NUM> may form all or part of a processing portion which may be, for example, a microprocessor, a microcontroller or some other suitable processing device. Memory <NUM> may form all or part of a memory portion that may be internal to the processing portion or operatively coupled to the processing portion and provide a storage medium for data and software executable by the processing portion for implementing functionality of processing unit <NUM>. Memory <NUM> can be any of one or more of a variety of types of internal and/or external storage media such as, without limitation, RAM, ROM, EPROM(s), EEPROM(s), FLASH, and the like that provide a storage register, i.e., a machine readable medium, for data storage such as in the fashion of an internal storage area of a computer, and can be volatile memory or nonvolatile memory.

Communication unit <NUM> may provide for communication between processing unit <NUM> and other components of system <NUM> or other external devices via the internet, cellular, WiFi, wired telephone line, or any other suitable means. For example, without limitation, communication unit <NUM> may facilitate communication with electronic devices such as a phone, tablet, computer, or other devices whether local or distant, directly or via a network. Communication facilitated by communication unit <NUM> may allow processing unit <NUM> to send and/or receive data from the component or device with which it communicates.

<FIG> is a flow chart showing basic steps of a method <NUM> in accordance with an example embodiment of the present invention, for identifying and/or providing a particular mask for a given patient that can be carried out by all or some the components of system <NUM> including the processing unit <NUM> and the output device <NUM>. Method <NUM> begins at <NUM> wherein a plurality of images of the patient's face are one or both of: captured by an image capturing device such as image capturing device <NUM> of <FIG>, or received by processing unit <NUM> from an outside source which has previously captured such images of the patient's face. The plurality of images may comprise <NUM>-D images, <NUM>-D images, or combinations thereof.

As previously discussed, embodiments of the present disclosure seek to utilize images which represent ranges of facial geometries of the patient's face. <FIG> shows an example of a plurality of such images, labeled A-J. Accordingly, the plurality of images, regardless of whether they are captured as <NUM>-D or <NUM>-D images, may include the patient's face in a plurality of predetermined poses. Some examples of such predetermined poses may include, for example, without limitation, having the patient pose with an open mouth, a closed mouth, open eyes, closed eyes, looking in various directions, facing in different directions (e.g., left, right, up, down,) etc. As another example, the plurality of images may include the patient's face in a plurality of natural poses. Such natural poses may be captured, for example, without limitation, by having the patient generally be themselves without striking any fixed poses while a sequence of images is captured. According to the invention as claimed, the plurality of differing expressions includes smiling, frowning, grimacing and pouting.

Next, at <NUM> the plurality of images or analyzed in order to generate a temporal model of the patient's face. Such generation of a temporal model may be accomplished in various ways depending on the type of images received/captured at <NUM>. For example, in an embodiment wherein a plurality of <NUM>-D images captured over time are utilized, the temporal model may be obtained by registering <NUM>-D images using known image registration methods.

As another example, one or more <NUM>-D images may be utilized along with a plurality of <NUM>-D to generate the temporal model. In such example, a <NUM>-D spatial model of the patient's face is generated using the one or more <NUM>-D images. The temporal model is then generated by registering the plurality of <NUM>-D images to the <NUM>-D spatial model. Additionally, in such example, information extracted from the plurality of <NUM>-D images, including landmarks, orientation, and features, may be used to refine the generated <NUM>-D spatial models.

As yet another example, a plurality of <NUM>-D images may be utilized to generate the temporal model. Such <NUM>-D images may include a reference object of known size or be captured from a device with known distance between the image capture device and the patient's face. <NUM>-D images with known size can be used directly (without ever creating a <NUM>-D spatial model) to create a temporal model that is <NUM>-D + time. The <NUM>-D spatial model can be analyzed in much the same way as the 3D spatial model (e.g. by calculating ranges for the inter-landmark distances). Alternatively, <NUM>-D images of known size could be used to approximate a 3D spatial model, for example by morphing a <NUM>-D template to fit the <NUM>-D images. Alternatively, 2D images could be used to create a <NUM>-D spatial model using any number of techniques known to one skilled in the art such as through the use of disparity maps in the epipolar plane, volumetric deep neural networks (DNN), or generative adversarial network correlations. In another approach, a plurality of <NUM>-D models is generated from the plurality of <NUM>-D images by using standard photogrammetric techniques. The temporal model is then generated by registering the <NUM>-D models.

Once the temporal model has been generated, the temporal model, and more particularly the information regarding the range or ranges of facial expressions contained therein, are used in determining a mask for the patient. Depending on various factors such as, for example, without limitation, time, budget, particular application, such determination may result in determining a design for a custom mask or a determination of an existing mask from amongst a plurality of masks of known sizes and/or geometries.

Finally, <NUM> the mask is then identified to the patient from amongst the plurality of masks to the patient and/or created, custom mask, and then provided to the patient. As an example, the patient may be provided with information, via any suitable form (e.g., electronically or via hardcopy), particularly specifying the mask (i.e., specifications which particularly identify the mask either from amongst other masks or how to construct from scratch or from components). For example, without limitation, a prescription for obtaining a particular mask or a CAD file or similar item containing instructions and/or dimensional information for constructing a custom mask. Alternatively, the mask may be identified to the patient by providing the patient with the actual mask, be it custom-made or an off-the-shelf item. In the case of a custom-made mask, an output device, such as output device <NUM> of <FIG>, in the form of a <NUM>-D printer or other suitable automated manufacturing device may be used to provide the mask to the patient.

From the foregoing, it is to be appreciated that by taking into consideration plurality of facial positions as described in a plurality of <NUM>-D or <NUM>-D images, embodiments of the present invention provide a patient with an all-around better fitting mask than conventional solutions.

Although the invention has been described in detail for the purpose of illustration based on what is currently considered to be the most practical and preferred embodiments, it is to be understood that such detail is solely for that purpose and that the invention is not limited to the disclosed embodiments, but, on the contrary, is intended to cover modifications that are within the scope of the appended claims. For example, it is to be understood that the present invention contemplates that, to the extent possible, one or more features of any embodiment can be combined with one or more features of any other embodiment. It is also to be appreciated that the overall and/or cross sectional shapes of structures described herein are provided for exemplary purposes only and that such shapes may be varied without varying from the scope of the present invention.

Claim 1:
A method (<NUM>) for identifying a mask for a patient, the method comprising:
receiving (<NUM>), by a processing unit (<NUM>), a plurality of images of a patient's face;
analyzing (<NUM>), by the processing unit, the plurality of images to generate a temporal model of the patient's face, wherein the temporal model is a numeric representation of the patient's face including <NUM>-D information and time-based variations of the <NUM>-D information;
determining (<NUM>), by the processing unit, a mask for the patient using the temporal model of the patient's face;
identifying (<NUM>), by the processing unit, the mask to the patient via an output device (<NUM>) in communication with the processing unit,
wherein the mask is for use in receiving a flow of a treatment gas to the airway of the patient,
wherein the plurality of images include the patient's face in a plurality of differing expressions, wherein the plurality of differing expressions includes smiling, frowning, grimacing and pouting.