Mask fitting system and method

Systems and methods for selecting a mask system for a patient are provided. Certain example embodiments include generating 3D contours of patients and selecting mask systems based at least on these contours. These contours may be generated by using, for example, a cushion of translatable pins, a nasal cannular scanning device, and/or a shadow stereopsis sensor. Certain other example embodiments allow images and/or videos to be captured and optionally synchronized. Then, images of various mask systems may be overlaid to determine how well a mask system fits. In still other embodiments, a user can hold a transparency corresponding to a mask design in front of the patient's face to determine how well a mask system fits.

FIELD OF THE INVENTION

This application is directed to a mask fitting system. In particular, the invention relates to a system for selection of a mask for patients suffering from a sleeping disorder, such as obstructive sleep apnea.

BACKGROUND OF THE INVENTION

There are several techniques which have been used in the past to fit mask systems to patients. In one example, a mask fitting template is used to obtain the necessary dimensions from the patient. Such mask fitting templates are available from ResMed Limited. In another example, a doctor or clinician will pick a mask system, such as ResMed's standard Ultra Mirage®, where a single mask system is believed to fit up to 80% of the population. Otherwise, the doctor or clinician selects a mask system for a patient simply by looking at the patient. Whichever technique or technique combination is used, selection of a mask system to obtain an optimal fit is limited by the knowledge of the clinician or doctor who is treating the patient.

With an ever increasing range of different masks available to fit a wide range of different people, it is increasingly difficult for clinicians or doctors to choose the most appropriate mask for the patient in the limited amount of time for fitting. The most appropriate fit, as used herein, may refer, for example, to the best human interface fit, maximum comfort, maximum seal, and/or the best type of technology to suit a patient's circumstances, needs and preferences. Therefore, patients in some cases may not be fitted with a mask system that would best fit the patient, which may result in less effective treatment and/or less patient compliance.

Therefore, it will be appreciated that a need has arisen to develop a system to allow for convenient and automated selection of a patient's mask system.

SUMMARY OF THE INVENTION

One aspect of the invention aims to ameliorate one or more of the above noted problems.

Another aspect of the invention is to match the patient with the most appropriate mask system, thereby improving the effectiveness of treatment and overall patient compliance.

Certain example embodiments provide a mask fitting system for selecting at least one mask system for a patient. Such systems may comprise a cushion of pins capable of being positioned over at least a portion of the patient's face. They may further comprise a processor operable to associate a location in a three-dimensional space with each pin in the cushion of pins; generate a contour of the patient's face or portion of the patient's face based at least in part on the location associated with each pin; and, based at least in part on the contour associated with each pin, select at least one mask system suitable for the patient. A display may be present, which may be operable to display the contour and/or the at least one mask system.

Certain example embodiments provide a method of selecting at least one mask for a patient. That method may comprise positioning a cushion of pins over at least a portion of the patient's face. A location in three-dimensional space can be associated with each pin in the cushion of pins. A contour of at least a portion of the patient's face based at least in part on the location associated with each pin also can be generated. The method may further comprise selecting at least one mask system suitable for the patient based at least in part on the contour and/or the location associated with each pin. Also, the contour and/or the at least one mask system may be displayed.

In certain example embodiments, a mask fitting system for selecting at least one mask system for a patient is provided. Such systems may comprise a sensor operable to generate a signal representing at least a portion of the patient's face comprising at least the patient's nasal area. Such systems also may comprise a processor operable to generate a contour of at least the patient's nasal area based at least in part on the signal, and further operable to determine a type and direction of nasal prongs suited to the patient based at least in part on the contour.

In certain example embodiments, a method of selecting at least one mask for a patient is provided. The method may comprise generating a signal that represents a portion of the patient's face comprising at least the patient's nasal area. Such systems also may comprise generating a contour of at least the patient's nasal area based at least in part on the signal. A type and direction of nasal prongs suited to the patient based at least in part on the contour can be generated.

In certain other example embodiments a mask fitting system for selecting at least one mask system for a patient is provided. Such systems may comprise at least one light operable to cast a shadow on at least a portion of the patient's face. A shadow steropsis sensor may be operable to generate a signal corresponding to the shadow. Such systems also may comprise a processor operable to generate a contour of at least a portion of the patient's face based at least in part on the signal.

In certain other example embodiments a method of selecting at least one mask for a patient is provided. Such methods may comprise shining at least one light on at least a portion of the patient's face. A shadow steropsis sensor may be used to generate a signal corresponding to the shadow. Then, a contour of at least a portion of the patient's face based at least in part on the signal can be generated.

Yet other example embodiments provide a mask fitting system for selecting at least one mask system for a patient. Such systems may comprise an image and/or video acquiring device operable to capture at least one image and/or video of at least a portion of the patient's face. A processor may be operable to process the at least one image and/or video to determine a physical characteristic of the patient's face based at least on the at least one image and/or video and at least one symbol, with the at least one symbol having been applied to the patient's face prior to the image and/or video acquiring device capturing the at least one image and/or video.

Yet other example embodiments provide a method of selecting at least one mask for a patient. Such methods may comprise applying at least one symbol to the patient's face. At least one image and/or video of at least a portion of the patient's face may be captured. Such methods also may comprise determining a physical characteristic of the patient's face based at least in part on the at least one image and/or video and the at least one symbol.

In certain example embodiments, a mask fitting system for selecting at least one mask system for a patient is provided. Such systems may comprise an image and/or video acquiring device operable to capture at least one image and/or video of at least a portion of the patient's face. A routine may be operable to allow at least one image of at least one mask system and the at least one image and/or video to be overlaid. Such systems also may comprise a display for showing the overlaid images and/or videos.

In certain example embodiments, a method of selecting at least one mask for a patient is provided. Such methods may comprise capturing at least one image and/or video of at least a portion of the patient's face. The at least one image and/or video may be displayed. Also, at least one image of at least one mask system may be displayed. The method may further comprise overlaying the at least one image and/or video and the at least one image of a mask system.

Certain example embodiments provide a transparency reflecting a design of a mask system, the transparency capable of being held to a patient's face to determine a goodness of fit of the mask system as indicated by the transparency.

Certain example embodiments provide a method of selecting at least one mask for a patient. Such methods may comprise providing at least one transparency reflecting a design of a mask system. The transparency may be held up to the patient's face. Such methods may further comprise selecting the at least one mask system based on a goodness of fit of the mask system as indicated by the transparency.

It will be appreciated that the above-described example embodiments also may be used as systems and/or methods for treating patients with sleeping disorders. In such example embodiments, one or more mask systems may be provided to the patients for use. It also will be appreciated that certain example embodiments will select at least two mask systems for a patient. In such example embodiments, a schedule for rotating among and/or switching between mask systems may be generated and/or provided to the patient.

Certain example embodiments provide a method of prescribing mask equipment to a patient for a sleeping disorder. The method may comprise compiling patient-specific data relevant to treatment of the sleeping disorder. At least two mask systems suitable for alternating use by the patient may be selected, based at least in part on the patient specific data.

Although the mask fitting system is described in relation to mask systems for patients who suffer from obstructive sleep apnea, the mask fitting system is not limited to such applications and may be provided to select patient interfaces and/or their accessories, such as headgear, for patients who suffer from other disorders. The mask fitting system may also be used as simply a method to record clinical details. Moreover, the mask fitting system can be used to select a mask/components for users who do not suffer from disorders, e.g., occupational health and safety masks.

Another aspect of the invention relates to a head support and camera mount assembly including a base, an upright provided to the base, and an arm extending outwardly from the upright. The upright includes a chin support adapted to support a patient's chin in use. The arm has a distal end structured to support an imaging device configured to capture at least one image of the patient's face when the patient's chin is resting on the chin support in use.

DETAILED DESCRIPTION OF ILLUSTRATED EMBODIMENTS

A mask fitting system1according to an embodiment of the present invention is illustrated schematically inFIG. 1. Mask fitting system1includes a mask fitting database2, one or more terminals6, and a communication channel4between database2and terminals6.

Mask fitting database2is provided to store data on a plurality of commercially available mask systems. The database2may be provided directly by a manufacturer of mask systems, or may be provided by a third party with the relevant information being obtained from the manufacturer.

Communication channel4allows communication between the database2and terminals6, which may be remotely located from database2. Communication channel4may be embodied in any suitable manner, for instance, wireless or land telecom line. Communication channel4may encompass direct hosting of the database, e.g., database, channel and a terminal may be included in a single PC system.

Channel4can be any known or later developed device or system for connecting each terminal6to the database2, including a direct cable connection, a connection over a wide area network or a local area network, a connection over an intranet, a connection over the Internet, or a connection over any distributed processing network or system. In general, the channel4can be any known or later developed connection system or structure useful to connect the terminal to the database.

Terminals6are provided at locations where mask systems are recommended to patients, either by way of sale of the mask systems or merely dispensing them. As illustrated inFIG. 2, each terminal6is provided with a reader12by which information (patient data) from the patient may be read, received, scanned or otherwise input. A controller14may then communicate some or all of this data to a database2by means of a communication port16.

A user interface18, including, e.g., a monitor or display, may be provided to indicate to the user (patient, interface fitter, clinician and/or physician) the most appropriate mask system or systems for the patient. Also, terminal6may have access to more general information about each mask system, and/or accessories that could be used with the recommended mask system(s). Such information can be displayed on the interface18. Further, a memory20may be provided to store data relating to the patient and/or database2, or to merely assist in the processing of the controller14.

In one example, reader12could include a camera (e.g., a digital or film camera, webcam, scanner, etc.) that is provided to take images of the patient from various angles, for example, profile and/or frontal views, for measurement of various dimensions of the patient's head. This is described in more detail below in relation toFIGS. 4-8. In addition or in the alternative, the terminal may include a facial scanner27(e.g. a facial scanner is commercially available from Cyberware). Scanner27may use 3D modeling techniques to scan the entire face, head, or other expected interfacing regions, or only selected portions thereof.

Other readers may include a handheld three-dimensional laser scanning device28(e.g. a commercially available device such as the Polhemus Cobra FastScan system). This system comprises a laser, reference transmitter, data acquisition unit and software. The data from the laser and the reference transmitter is fed to a Data Acquisition Unit (DAQ). The DAQ plots the data into a 3D plane. This information can be translated using the provided software to different 3D file formats such as wrl, stl and iges.

The Polhemus Cobra FastScan scanner has an accuracy 0.5 mm and should be held at least 10 cm away from the object. The Cobra FastScan can be operated in two different modes. In the first mode it collects data as a laser sweep and 3D models are created using the data, the file format can be output in many different engineering formats the majority being either 3D mesh or point cloud. In the second mode data is collected as 3D points in an x, y and z coordinate system. These points are recorded to a Comma Separated Values (CSV) file (or any file type, preferably with a known layout) which is a simple file that can be fed into Excel or by any programmable text reader.

When scanning a person, care must be taken to ensure that the eyes are closed. Scans of people with dark skin can be difficult, in which case the laser sensitivity has to be adjusted or a white powder can be applied to the face. During scanning, the scanned person must not change his or her facial expressions, however he or she can move their head around as the reference transmitter monitors position change (it is directly connected to the DAQ).

Several non-limiting examples of output options include:3D scan of the face via image file (wrl, stl, iges) or a test file giving reference points (csv); and,Points taken at discrete positions (text file, csv).

Alternatively a stylus can be attached that is directly attached to the DAQ and can be run along the face to measure distances (e.g., nose bridge).

One or more of the following advantages of this system exist:The profile can be stored for further use;Quick and efficient (e.g. 5 minutes per scan and 10 minutes to process the scan, note: processing can be left until night);Improved accuracy with respect to hand measurement;Image can be saved straight to an stl format (or other image file format), from which an SLA (solid) can be developed straight away;Use of a design package such as ProE means that objects (e.g., masks) can be added around the scanned facial profile; and,Measurements can be taken whilst patients are lying down.

An alternative to the Polhemus FastScan is a 3D laser scanner, which can be tripod mounted to scan 3D objects. Such laser scanners can capture the color of the object scanned with the 3D data. High accuracy lenses can be used, and preferred embodiments may have an accuracy of between 50 microns to 0.5 mm. In the situation where a completed 3D head of a patient is required, the laser scanner may scan the object from a number of different angles and the scans are then stitched together with a suitable scanning software package.

Of course, other scanners, readers or input devices are also contemplated, and the embodiments are not limited to the examples provided.

For example, the scanner system may take the form of a 3D scanner that is movably mounted or relative to the patient. The 3D scanner can rotate about the patient to scan along a predetermined circular path, e.g., 0-360° or any amount in the range of 0-360°. Dental X-rays are sometimes taken with such a system. Moreover, the scanner would be stationary while the patient's support (e.g., a chair or platform) rotates.

In a preferred embodiment, the scanner preferably covers the entire head, including the individual features, e.g., ears, nostrils, etc. As further masks are developed and require new data points to be utilized, further scans would not be required. For example, in considering a new headgear sized to avoid behind the ears, the scans would already contain this data. Therefore, upgrades of masks would not require re-scanning. Moreover, using the system described below, patients who wear masks can be automatically informed, either directly or through their clinician, of new mask systems/components that are more appropriate and/or provide a better fit for the patient.

FIG. 3shows that the mask system database2includes a communication port22to allow communication with terminal6(FIG. 2), via channel4. Communication port22may also allow communication with manufacturers for receiving data regarding mask systems. In addition, communication port22may receive information from other third parties, such as governmental agencies which may provide product reviews of the mask systems, possible accessories, product recalls, etc.

Mask system database2includes a controller24that interfaces with a memory26. Memory26includes information (mask system data) regarding a plurality of mask systems that are commercially available. Such information includes, for example, and without limitation, data regarding the dimensions and/or weight of the mask system. Such data may also include the intended sex, age, age range, or size of patients with whom the mask system is intended for use.

In a preferred embodiment, the mask system data is based on mask system grading criteria such that mask systems with particular disadvantages or advantages are scored, rated or graded accordingly. For example, if a particular mask system is not conducive for a patient who likes to read using reading glasses when the mask system is being used, e.g., because the mask system includes an upwardly extending forehead support that may obstruct the patient's field of view and/or interfere with reading glasses, then that particular mask system would receive a lower weighted score for that particular mask system grading criteria, e.g., this mask system would receive a grade of “3” (on a scale of 1-10, 10 being the best possible grade). On the other hand, if a mask system is particularly useful for patients who have a beard and/or mustache, then the weighted score for that particular criteria will be relatively higher, e.g., a “9,” when compared to other mask systems which are not particularly conducive for patients who have facial hair.

In an embodiment, a relative measure of the expected goodness of choice or fit may be presented to the mask fitter. This may be a star ranking system or similar. For example, a mask size that appears to fit very well in all areas may be given 5 stars. In another example, all mask sizes may be ranked and the top two mask sizes may both receive a 3 star ranking. This may indicate to the mask fitter that it is a bit of a toss-up between the first two sizes. Still another example may have the top ranked mask receive only a one star ranking. This may indicate to the mask fitter that the most likely choice is not expected to be a good fit. This arrangement may add more value to the mask recommendations than is currently available. The same principle may be applied to mask type so that a mask type that is expected to suit the patient very well based upon lifestyle selections and clinical history may receive a high ranking. This arrangement adds more value to the mask recommendations than is currently available. Of course, percentages or a number of noses or other mechanisms may be used in place of stars.

Other possible criteria includes mask size maximum fit dimensions, mouth width, nasal bridge width or depth, total nose depth, nose length, nostril spanning/sparring and angle, ear position, circumference or width of head, etc. Additional mask system grading criteria is described below.

In general, several medically acceptable mask system criteria can be established for universally grading any given mask system in a consistent manner. Such criteria can be used to establish database2, shown inFIG. 2. In one embodiment, each mask/accessory can be provided with a tagging device, e.g., a bar code, uniform product code, RFID, etc., with data relating to product description, code, batch, purchase, etc. The information from the tagging device may be read and input into the database.

In addition to or in the alternative of using grading by best dimensions, etc., grading by “elimination” may also be used. For example, the questionnaire (an example of which is described below with reference toFIG. 5) reduces the number of mask options to select from by eliminating non-appropriate masks. Therefore, improved accuracy and speed of selection can be achieved by selecting from a smaller pool of potential masks.

In operation, the mask fitting system1is configured to produce a best-fit mask fitting result which is indicative of one or more commercially available mask systems that would be most appropriate for the patient. The result is generated in accordance with a comparison of patient data (received at terminal6) with mask system data (stored in mask system database2). The comparison may be performed by the controller of the terminal6, the controller of database2, or a combination thereof.

FIGS. 4,5,6,7A,7B and8illustrate sequential screen shots of a mask fitting system according to an embodiment of the present invention. In general, the process includes the entry of patient details, filling out of a questionnaire, imaging, dimensioning and then recommending a mask.

FIG. 4is a screen shot displaying entry blocks for patient details, such as name, age, data of birth, etc.

FIG. 5is a questionnaire which includes several questions which are answered by the patient or clinician. Generally speaking, the questionnaire is used to accumulate patient data unique to the patient. Patient data may include, but is not limited to, physical characteristics, prior history of mask use, the patient's sleeping characteristics and/or the patient's relevant facial and/or head dimensions. Physical characteristics may include the patient's age, whether the patient wears glasses, whether the patient has facial hair, whether the patient wears dentures, and/or whether the patient is male or female.

The prior history of mask use may include the type of breathing the patient normally experiences, e.g., mouth breathing or nose breathing. Other criteria may include whether the patient has in the past experienced leak problems or anxiety when wearing the mask. Additional criteria may include information as to whether the patient likes to watch TV or read while wearing the mask, prior to sleep.

Sleep characteristics may include information about the typical sleep patterns of the patient, e.g., whether the patient is a restless sleeper, which may affect stability of the mask; stability may be yet another criteria built into the database.

There may also be questions designed to gauge the importance of the patient's facial image in the bedroom relative to therapeutic values. For example, a mask may provide a low visual impact but may be less likely to achieve a good seal. Some patients may prefer to just choose a mask most likely to be best for therapy but others will weigh visual impact aspects more highly.

Other factors that may affect mask selection include skin texture, skin floppiness, degree of skin wrinkling, and skin oiliness, which may also include questions answered by the clinician even if not asked of the patient.

A sample questionnaire is provided below and may include the following questions:

Mask Grading Criteria

1. Whether the patient is a new patient.a. Yesb. No

3. Degree of restless during sleepa. Not restlessb. Light restlessnessc. Some restlessnessd. Heavy restlessnesse. Extreme sensitivity

4. Degree of anxiety from wearing a maska. Unknown/First time patientb. Nonec. Slight distractiond. Moderate distractione. High discomfortf. Claustrophobia

5. Does the patient have a moustache?a. Yesb. No

6. Does the patient have a beard?a. Yesb. No

7. Does the patient have any mask leak or seal problems?a. Unknown/First time patientb. No leaksc. Light leakaged. Moderate leake. Heavy leakf. Extreme leak

8. What treatment pressure does the patient require?a. CPAP 12 or lessb. CPAP greater than 12c. Bilevel

9. Does the patient have full dentures?a. Yesb. No

10. Does the patient want to read or watch TV with the mask on?a. Yesb. No

The mask grading system/algorithm is adaptable, so that new grading criteria or changes to the existing criteria can be implemented simply by updating the database, without the need to change the rest of the system. The user questions may form a part of the overall fitting system algorithm, as shown, e.g., inFIG. 16.

1. Mask Grading System Example

In the example below, the following answers to the grading selection criteria, produce the mask system grading shown below for currently available mask systems. In this example, all of the mask examples are ResMed's although other masks could be included.

To determine the best possible fit among the available mask sizes currently stored in the database, the measured patient dimensions are compared with the relevant dimensions and/or characteristics of the stored mask sizes.

A preferred embodiment of the invention grades mask sizes by comparing the measured patient facial dimensions with the nominal “best fit” dimensions stored for each mask size in the database. However, other methods, such as those using statistical techniques can also be used.

For example, relevant dimensions of the mask system can be scanned, much in the way of a patient's dimensions may be scanned. In particular, the face contacting portion of a plurality of mask interfaces may be scanned, so as to capture the various topographical features of the mask, e.g., depth, width, contour, etc. This information can be stored in a database or registry. Further, the patient's facial features (which can be scanned as well) can be compared against the scanned patient interfaces and a best fit scenario may be obtained using, e.g., statistical analyses methods. Moreover, the results of the comparison can simply be used as one metric or criteria of fit, which can be weighted relative to other metrics and/or criteria (e.g., the patient's questionnaire, etc.).

The patient dimensions include, but are not limited to one or more of the following:

1. Nasal bridge width

2. Nasal root depth

7. Mouth width

8. Facial height

Dimensions which are necessary to fit a mask system to a patient vary, depending on the type of mask system involved. For example, a nose mask may require different information than is required for a full face mask or mask systems using cannula, nozzles, puffs, etc.FIG. 17, which is more fully described below, illustrates a sample mask fitting algorithm.

In one embodiment, the dimensions of the patient's head can be simply measured with a template or ruler and input into the terminal6. However,FIGS. 6,7A and7B show a more preferred embodiment, in which one or more images of the patient are obtained (by capturing the image), and then dimensions of the patient's head are obtained (in response to user input).

In the screenshot shown inFIG. 6, one or more images of the patient are captured and displayed on a display screen at terminal6. The image(s) can be created using, e.g., a digital or film camera, webcam, still imaging system, and/or any system able to capture images by screen “grabbing” or video still capture, any of which may be the reader12described in relation toFIG. 2above. The screenshot shown inFIG. 6may include instructions on how to use a reader to create the recommended images.

In this embodiment, frontal and profile images of the patient are provided. However, nasal or other views can be incorporated as desired. Moreover, any reader that can transfer real time mask interfacing regions of a patient's body is readable into physical dimensions, e.g., overall dimensions or at least one plane (e.g., frontal view) can provide overall dimensions, such as nose width and head width.

After the imaging step, user input is utilized to obtain one or more dimensions from the patient's front and/or profile images. Once the image appears on the screen, as shown inFIGS. 7Aand/or7B, the patient or clinician is prompted to use the cursor to align crosshairs on the screen with various points on the patient's face. Different points will be recommended depending on whether the patient prefers nose masks or full face masks, etc. However, if the patient or clinician desires that all types of masks be considered in the selection process, then all the suggested dimensions should be entered and/or considered.

As shown inFIG. 7A, the cursor, e.g., in the shape of a crosshair, is moved to several points on the face and “clicked” so as to derive the relative dimensions for entry into the system. For example, points P1and P2correspond to the sidewalls of the nostrils, i.e., the widest point of the patient's nose. Selection of additional points may result in an even better mask fit, although additional data points may not be necessary, depending on the type of mask of interest. For example, the following points can be measured to provide the best possible mask fit: point P3(the bottom tip of the nose), point P4(on the nasal bridge between the eyes, point P5(the middle of the patient's forehead) and point P6(the patient's chin), etc.

It is preferable that a comprehensive set of dimensions be obtained so that if a patient needs a full face mask, as opposed to a nasal mask, the clinician/dealer could recommend a new mask without the patient returning for a subsequent fit.

The same process is repeated for the profile image of the patient, as shown on the display inFIG. 7B. Of course, the profile image point(s) could be entered first, followed by the frontal image point(s). Using the profile image, the clinician or user will then be prompted to use the cursor to “click” on a number of points on the patient's head. For example, points P7-P16are illustrative of the points which the patient may be prompted to enter into the system. P7-P16are generally described as follows: P7(chin), P8(lips), P9(joint between upper lip and bottom of nose), P10(bottom of forehead), P11(top of forehead), P12(front of ear), P12.1(rear of head), P12.2(top of patient's head), P13(tip of nose), P14(joint between cheeks and base of nose), P15(base of nasal bridge), P15.1(peak of bridge between eyes), P16(rear of eye socket where temple begins). Other points and/or dimensions could be added as desired.

Some of these points, e.g., points P13, P14, P15and P15.1may be relevant to use for consideration of nose masks or full face masks, but may not be relevant to consideration for use with nasal cannula. Points P10and P11may help with consideration of mask systems having forehead supports, by providing the slope of the patient's forehead. This information may also indicate the most appropriate adjustment setting for an adjustable forehead support, for best fit with the patient. Points P12, P12.1, P12.2and/or P16may be relevant for fitting a particular headgear to the patient's head.

In a preferred embodiment, frontal and profile images are all that are required to fit a mask. However, a nasal image could be used in a similar manner to the above if desired.

Once these suggested points are entered into the system, the fitting system may produce a best-fit mask system result. SeeFIG. 8. The result can take the form of a single mask system which is judged to be most appropriate for the patient, or the result may include a listing of two or more masks which the patient may wish to consider. The mask fitting result may be presented in order of preference. The results page may include information about mask accessories, mask system reviews, etc., or links to such information, e.g., via database2.

Further, certain example embodiments may generate a system result suggesting multiple mask systems (e.g. alternating between two or more mask systems) that may be appropriate for a patient. For example, the patient could use a first mask system for a predetermined period of time (e.g. one day, one week, one month, etc.) and then alternate with a second mask system. Recommending multiple mask systems may be advantageous for several reasons. For example, it may not be possible to recommend a single, best-fit system (e.g. because not enough data were gathered, multiple mask systems may fit equally well, etc.). Also, different mask systems generally will fit the same patient differently (e.g. because of different materials used, different adjustment mechanisms, different points at which masks contact portions of the patient, etc.). By way of example and without limitation, an aspect of the techniques for fitting mask systems to patients described herein seeks to find the most comfortable fit for patients (e.g. by eliminating irritation areas caused by where the mask comes into contact with the patient's face, etc.). However, it may not always be possible to eliminate all irritations, especially when mask systems must be used for extended periods of time. Thus, certain example embodiments may recommend a number of mask systems for a patient. The recommendation may come in the form of a schedule, which may be displayed and/or printed for the patient. The schedule may include scheduling information, which may include the predetermined amounts of time for which a patient should wear each particular mask. A patient may rotate among, alternate, or switch between, recommended mask systems, thereby potentially reducing irritations and improving both short- and long-term comfort.

Other embodiments of the invention are shown inFIGS. 7B-1to7B-3. To determine the appropriate mask fit for a patient a set of predetermined points can be used that are unique to particular features of the face.FIG. 7B-1is an example of frontal facial points that could be used to determine the appropriate mask size for a patient.

In an embodiment, the operator may select or fit curves that match shapes on the patient's face such as the frontal and profile shapes of the patient's nose. This may also be used to select sizes by comparing the curves to mask or cushion shape curves.

Still other embodiments allow different functions to be performed after image(s) and/or video(s) of the patient are acquired by the camera, web cam, or other imaging device. As noted above, certain processing may be performed automatically to generate a 2D image of one's face. The accuracy of such systems may be improved with minimal user (e.g. patient, clinician, or other human) interaction. For example, one or more stickers depicting a symbol (e.g. a cross or the like) may be supplied to the patient. Applying the symbols to the patient's face prior to imaging may allow a computer system processing the image(s) to quickly find key points on the patient's face (e.g. the points described in relation toFIGS. 7A-7Band7B-1-7B-3). The symbols also may help the system gauge distance and/or orientation of the patients face on the basis of the fixed dimensions of the sticker in order to gain a proper measurement of the patients face. It will be appreciated that a mask, hat, template, or the like may be used in place of a sticker, and that multiple stickers (or the like) may be used. It also will be appreciated that the images may be processed by software, hardware, firmware, some combination thereof, or the like.

In certain example embodiments, once a 2D image is acquired, the patient, clinician, or operator may use a computer system to overlay 2D images of the various masks available onto the image of the patients face to determine appropriate mask sizing. Alternatively, the computer system may automatically overlay the mask templates to determine the best fitting mask system. The system may use a single image, or it may synchronize photos from multiple cameras, potentially allowing for multiple viewpoints and thus potentially better fittings. Also, in certain example embodiments, images from different angles may be used to generate a 3D contour of the patient's face. Incorporating symbols on the patient's face at predetermined positions helps reduce the processing power required when generating such contours. It also will be appreciated that the images may be processed by software, hardware, firmware, some combination thereof, or the like.

In a tangible, real-world analog to the computer-mediated systems described above, a patient may be provided with transparencies (e.g. acetate sheets) or similar other products showing the outlines of various masks (e.g. the transparencies may have outlines pre-printed on them). Then, the patient may hold the transparency or other product up to a mirror to determine the appropriate mask sizing.

In another embodiment, the measurement ranges for each dimension of the sizes of a mask may be considered. For example, if there are two sizes for a mask, small and large, the ranges may be as follows:

where:Values less than A are outside range for the given dimension;Values between A and B suit the small size (in this dimension); andValues between B and C suit the large size (in this dimension).

This may be repeated for multiple dimensions. A lookup table or flowchart may then be used to supply a weighting for each of the sizes of the mask.

For example (extending the example above), in the case where there are two mask sizes for a given type and two dimensions under consideration, the following table may be produced:

It is noted that the logic embodied in the selected values in the table may permit decisions such as: Choose the largest size that any of the dimensions suit.

Of course, the ranges and relative weightings may be entirely arbitrary. Ranges may be selected so that borderline values between sizes are taken into account.

2.1 Method 1: Datum Points (e.g., Using the Polhemus Cobra FastScan)

The stylus/laser pointer would be placed on points1-7, as shown inFIG. 7B-1, in order. Thus, data would be then sent to the software fitting program to calculate the distances between points and then a recommendation for the most appropriate mask size can be made based on the dimensions.

2.2 Method 2: Datum Points (e.g., Using the Minolta Laser Scanner)

This method uses the same concept as that outlined in Method1of using datum points, however instead of using a laser pointer/stylus to directly identify each point, a coloured tab T, as shown inFIG. 7B-2, is placed on selected feature points. The face is then scanned using a tripod mounted Minolta laser scanner which will map the coloured points onto a 3D model, using these points the dimensions of the patient can be found using any CAD system or CAD integrated system that is capable of importing 3D meshes. An example of software systems that could do this is Geomagic, Pro Engineer, Solid Works and IDEAS.

The Delta View program (Screenshot inFIG. 7B-3), from Polhemus can be used to show how the patient's face has changed between full facial scans when the initial mask recommendation was made. Changes in the patient's weight can affect the way the mask fits onto the face the patient over time, especially in barriatric applications. This software can show geometrically how the patients face has changed and the specific areas where the most change has occurred. With this information a recommendation could be made from the software as to whether the patient requires a new mask size.

2.4 Method 4: Full Facial Scan (e.g., Using the Polhemus or Minolta Scanning Systems)

The face of the patient is scanned using the 3D laser scanner, the image is imported into a CAD package and the measurement analysis with the CAD package is used to measure the dimensions that are critical for fitting the mask.

The system may allow a clinician to override the choice, and may include “fuzzy logic” that could learn to adapt to a particular clinician's fit methods or needs. “Fuzzy logic” is optional and if included, it need not be enabled for each system user.

3. Exemplary Camera Mounts

As described above, e.g., especially in relation toFIGS. 6-7B, the effort in taking several measurements manually is replaced with using a digital image to indicate the measurements. Preferably, the clinician or patient should align his head with a camera so as to provide for consistent and accurate results. This may be achieved by providing a template, e.g., a head support, for use with the camera. The template preferably would be fixed in relation to the camera such that the patient's head assumes a predetermined orientation. In addition, the patient's head will be preferably spaced from the camera at a predetermined distance/location, so that measurement results are consistent from patient to patient. Alternatively, the measured facial dimensions can be calibrated for each image.

The following illustrates several head supports and camera mounts according to alternative embodiments of the present invention, which may share common characteristics and features. It is to be understood that one or more features of any one embodiment may be combinable with one or more features of the other embodiments. In addition, each single feature or combination of features in any of the embodiments may constitute an additional embodiment.

3.1 First Illustrated Embodiment of Head Support and Camera Mount

FIGS. 8A-1to8A-3illustrate a head support and camera mount assembly500according to an embodiment of the present invention. Assembly500includes a base502configured to clamp onto the side of a table or desktop. Of course, base502could rest on the top of a table or desk. Base502supports an extrusion or upright504with an upper end including a chin support506for the patient. Extrusion504may also support an arm508that is preferably pivotably mounted to the extrusion504via a pivot joint507. Arm508includes a distal end to support an imaging device510, e.g., a camera. Arm508may be mechanically operated. In certain example embodiments, the arm may be adjusted (e.g. by height using a telescopy arrangement, etc.) to accommodate different people with different characteristics (e.g. people of different heights, head sizes, etc.).

The camera mount is designed to enable consistent frontal and profile images to be taken of a patient's face when his or her head is resting on chin support506. Imaging device510is supported at the end of the arm508attached in a fixed position, e.g., by a screw from the base and plugs at the sides. It will be appreciated that a light may also be attached to the arm or the imaging device directly. It also may be present proximate to any part of the assembly. The arm508locates on pivot507and rotates through a predetermined extent, e.g., about 90 degrees. Arm508may lock or rotate between or into two fixed positions, e.g., by detents or the like, to provide front and profile camera images without the patient moving or disassembly of any components. Arm508may swing within a groove provided in pivot507. Pivot507may include stops at each extreme end of the desired movement angle, e.g., about 90°. As shown inFIG. 8A-2, for example, the arm508rotates on the pivot507via the 90° slot520in the arm508. A locking mechanism uses a small tab522with a bump524that can be seen on the arm508. The chin rest506is located via projections527that engage with the holes526to clamp the arm (seeFIGS. 8A-2and8A-3). The tab522on the arm508deflects during rotation and the bump aligns with the notches528visible on the underside of the chin rest in the two 90° locations (seeFIG. 8A-3). The circular button530that can be seen on the pivot507locates the pivot by a snap fit with a hole the extrusion504. The inclined surface between the pivot block and extrusion is one method for helping to locate the components in a uniform manner.

Chin support506is designed to enable a patient to comfortably rest his head and locate his face at a known fixed distance from the camera510. Chin support506attaches to the pivot507and remains fixed when the camera arm is rotated. It is easily removable for cleaning. The arm length is designed so that the distance between the camera and patient's face is sufficient to capture all of the required facial dimensions.

Extrusion504is a strong and stable support column for the system. The extrusion's height above the standard desk/table enables a comfortable sitting posture for when the patient is resting his chin. The pivot507clips into the top of the extrusion and the other end of the extrusion is attached to a base plate/clamp502.

Base/clamp502provides a secure attachment of the entire camera rig to the top of a desk or table. Camera mount can be disassembled for flat packing. Camera mount can be easily assembled by the user.

3.2 Alternative Embodiments of Head Support and Camera Mount

FIGS. 8B-1to8Y-2illustrate various features of a head support and camera mount according to alternative embodiments of the present invention. Each illustrated embodiment may include one or more of the following features:

1. Rotatable arm being lockable in an in-use configuration and a collapsed configuration. A squeeze button may be provided at the hinge region between the arm and the upright to allow rotation of the arm when squeezed and prevent rotation (i.e., lock the arm) when not squeezed. The hinge may be dampened to prevent the arm from banging against the upright if dropped.

2. Telescopic pneumatic system that provides controlled, steady height adjustment of the upright. The pneumatic system may support the weight of the upright to facilitate upward movement of the upright. In this arrangement, the upright would need to be pushed downwardly to move the upright downwardly. A push button may be provided to the pneumatic system, e.g., on the upright, which allows height adjustment when pressed but maintains the height of the upright when released. The upright may be raised by 10% to 500% of its height, e.g., 150 mm.

3. Base of arm may be selectively slidable up and down the upright.

4. Camera and/or camera housing may be fixed or rotatable on the end of the arm.

5. A slidably mounted bottom upright member that may be slid out of the base of the upright. The bottom upright has a flange with a clamp member screw threaded therethrough. An upper end of the clamp member bears against an undersurface of the table onto which the device is mounted. The side of the bottom upright member then cams against an inside surface of the upright. An embodiment based on the same principle with a slidable sleeve is shown inFIG. 8L-1. The cam clamping effect in these embodiments is similar to that used in common G-clamps.

6. Bushings provided to stop the patient from squashing his/her finger between telescoping parts.

7. Arm rotates laterally as well as up and down. The arm may rotate laterally through approximately 90 degrees in both directions. This arrangement allows the camera to take side photos of the patient's face. There may be a button to allow this rotation and the button may be detented in at least three positions, e.g., straight ahead, right side, and left side.

8. Device can be made from steel, plastic, and/or aluminum. However, other materials are possible.

3.2.1 First Alternative Embodiment

FIGS. 8B-1to8B-18illustrate various views of a head support and camera mount assembly2000according to another embodiment of the present invention. As illustrated, the head support and camera mount assembly2000includes a base2002adapted to clamp onto the side of a table or desktop, an upright2004including a chin support2006, and an arm2008that supports an imaging device2010, e.g., camera.

The arm2008is mounted to a pivot joint2007that allows the arm2008to rotate laterally with respect to the upright2004, e.g., 90 degrees in both directions. In addition, the pivot joint2007includes a hinge region that allows the arm2008to rotate up and down between an in-use configuration (see solid lines inFIGS. 8B-15and8B-17) and a collapsed configuration (see dashed lines inFIGS. 8B-15and8B-17).

The upright2004includes a telescopic pneumatic system to control height adjustment of the upright2004. As schematically shown inFIG. 8B-18, the upright2004includes a first pneumatic cylinder2030provided to the base, a second pneumatic cylinder2032telescopically engaged with the first pneumatic cylinder2030, and an outer tube2034attached, e.g., by a screw thread arrangement, to the second pneumatic cylinder2032. An actuator2036is operatively connected to the second pneumatic cylinder2032that allows the second pneumatic cylinder2032to move into and out of the first pneumatic cylinder2030, which adjusts the height of the upright2004. A button2038, e.g., rubber button, is provided to the actuator2036to manually actuate the actuator2036.

As best shown inFIGS. 8B-6and8B-7, the button2038is provided to a top of the upright2004, e.g., on top of the chin support2006.FIG. 8B-5illustrates the aperture2040in the chin support2006for the button2038. The button2038is sealed, cleanable, and may be flush or below the chin support's surface. The flush mounting may help to prevent the patient's chin from pressing the button2038. In an alternative embodiment, the button2038and actuator2036may be axially offset and operably connected by a lever.

The base2002is in the form of a clamp including an upper flange2050that supports the upright2004and a lower flange2052that supports a clamp member2054screw threaded therethrough. The lower flange2052includes an extrusion2056that engages within a corresponding opening2058provided in the upper flange2050to support the lower flange2052on the upper flange2050(seeFIGS. 8B-8and8B-9).

FIG. 8B-13illustrates the engagement between the upright2004, upper flange2050, and lower flange2052.FIG. 8B-13Billustrates an alternative arrangement to that shown inFIG. 8B-13. As illustrated, the cross-sectional configuration of the upright2004, upper flange2050, and/or lower flange2052may vary. It is noted that the hook-like areas in the cross-section are adapted to receive fasteners (self-tapping or otherwise), e.g., screws.

3.2.2 Second Alternative Embodiment

FIGS. 8C-1to8C-3illustrate various views of a head support and camera mount assembly2100according to another embodiment of the present invention. As illustrated, the head support and camera mount assembly2100includes a base2102adapted to clamp onto the side of a table or desktop, an upright2104including a chin support2106, and an arm2108that supports an imaging device2110, e.g., camera.

The arm2108is mounted to a pivot joint2107that allows the arm2108to rotate laterally with respect to the upright2104, e.g., 90 degrees in both directions. In addition, the pivot joint2107includes a hinge region that allows the arm2108to rotate up and down between an in-use configuration (seeFIGS. 8C-1and8C-3) and a collapsed configuration (seeFIG. 8C-2).

3.2.3 Third Alternative Embodiment

FIGS. 8D-1to8D-3illustrate various views of a head support and camera mount assembly2200according to another embodiment of the present invention. As illustrated, the head support and camera mount assembly2200includes a base2202adapted to clamp onto the side of a table or desktop, an upright2204including a chin support2206, and an arm2208that supports an imaging device2210, e.g., camera.

The arm2208is mounted to a pivot joint2207that allows the arm2208to rotate laterally with respect to the upright2204, e.g., 90 degrees in both directions. In addition, the pivot joint2207includes a hinge region that allows the arm2208to rotate up and down between an in-use configuration (seeFIGS. 8D-1and8D-3) and a collapsed configuration (seeFIG. 8D-2). As illustrated, the pivot joint2207is provided to a lower region of the upright2204, e.g., with respect to arrangement shown inFIGS. 8C-1to8C-3.

3.2.4 Fourth Alternative Embodiment

FIGS. 8E-1to8E-2illustrate various views of a head support and camera mount assembly2300according to another embodiment of the present invention. As illustrated, the head support and camera mount assembly2300includes a base2302adapted to clamp onto the side of a table or desktop, an upright2304including a chin support2306, and an arm2308that supports an imaging device2210, e.g., camera.

The arm2308is mounted to a pivot joint2307that allows the arm2208to rotate laterally with respect to the upright2304, e.g., 90 degrees in both directions. As illustrated, the assembly2300includes a tubing arrangement, e.g., square upright tubing and L-shaped arm, similar to the assembly2000described above.

3.2.5 Fifth Alternative Embodiment

FIGS. 8F-1to8F-2illustrate various views of a head support and camera mount assembly2400according to another embodiment of the present invention. As illustrated, the head support and camera mount assembly2400includes a base2402adapted to clamp onto the side of a table or desktop, an upright2404including a chin support2406, and an arm2408that supports an imaging device2410, e.g., camera.

The arm2408may rotate laterally via a pivot joint provided to the upright2404. Alternatively, the arm2408may rotate laterally along with the upright2404that may be rotatable with respect to the base2402. As illustrated, the upright2404and arm2408include relatively small diameter circular tubing.

3.2.6 Sixth Alternative Embodiment

FIGS. 8G-1to8G-2illustrate various views of a head support and camera mount assembly2500according to another embodiment of the present invention. As illustrated, the head support and camera mount assembly2500includes a base2502adapted to clamp onto the side of a table or desktop, an upright2504including a chin support2506, and an arm2508that supports an imaging device2510, e.g., camera.

The arm2508includes a pivot joint2507, e.g., integrally formed in one-piece therewith, that allows the arm2508to rotate laterally with respect to the upright2504, e.g., 90 degrees in both directions.

3.2.7 Seventh Alternative Embodiment

FIGS. 8H-1to8H-3illustrate various views of a head support and camera mount assembly2600according to another embodiment of the present invention. As illustrated, the head support and camera mount assembly2600includes a base2602adapted to clamp onto the side of a table or desktop, an upright2604including a chin support2606, and an arm2608that supports an imaging device2610, e.g., camera.

The arm2608is pivotally mounted to a joint2607that allows the arm2608to rotate up and down between an in-use configuration (seeFIG. 8H-2) and a collapsed configuration (seeFIG. 8H-1). The joint2607is also slidably mounted within a track portion2660provided to the upright2604(seeFIG. 8H-3) which allows the arm to slide up and down with respect to the upright2604, e.g., for collapsing as shown inFIG. 8H-1.

The imaging device2610may also be pivotally mounted to the arm2608to allow adjustment of the imaging device2610during use and/or for storage.

The arm2608may rotate laterally along with the upright2604that may be rotatable with respect to the base2602.

3.2.8 Eighth Alternative Embodiment

FIGS. 8I-1to8I-2illustrate various views of a head support and camera mount assembly2700according to another embodiment of the present invention. As illustrated, the head support and camera mount assembly2700includes a base2702adapted to clamp onto the side of a table or desktop, an upright2704including a chin support2706, and an arm2708that supports an imaging device2710, e.g., camera.

The arm2708is mounted to a pivot joint2707that allows the arm2708to rotate laterally with respect to the upright2704, e.g., 90 degrees in both directions. The upright2704may include a telescopic arrangement to control height adjustment of the upright2704.

3.2.9 Ninth Alternative Embodiment

FIGS. 8J-1to8J-2illustrate various views of a head support and camera mount assembly2800according to another embodiment of the present invention. As illustrated, the head support and camera mount assembly2800includes a base2802adapted to clamp onto the side of a table or desktop, an upright2804including a chin support2806, and an arm2808that supports an imaging device2810, e.g., camera.

The arm2808is pivotally mounted to a joint2807that allows the arm2808to rotate up and down between an in-use configuration and a collapsed configuration. The joint2807may also be rotatable with respect to the upright2804, e.g., via pivot pin2860provided to the upright2804(seeFIG. 8J-2).

Also, the upright2804may include a telescopic arrangement to control height adjustment of the upright2804.

3.2.10 Tenth Alternative Embodiment

FIGS. 8K-1to8K-3illustrate various views of a head support and camera mount assembly2900according to another embodiment of the present invention. As illustrated, the head support and camera mount assembly2900includes a base2902adapted to clamp onto the side of a table or desktop, an upright2904including a chin support2906, and an arm2908that supports an imaging device2910, e.g., camera.

The arm2908is pivotally mounted to a joint2907that allows the arm2908to rotate up and down between an in-use configuration (solid lines inFIG. 8K-1) and a collapsed configuration (dashed lines inFIG. 8K-2).

The joint2907and arm2908thereof may rotate laterally with respect to the upright2904. Also, the upright2904may include a telescopic arrangement to control height adjustment of the upright2904.

FIG. 8K-2illustrates a portion of a housing2970that supports a camera for the imaging device2910. As illustrated, the housing2970includes a connecting portion2972adapted to connect to the arm2908.

FIG. 8K-3is a front view of the imaging device2910showing camera2980and housing2970.

3.2.11 Eleventh Alternative Embodiment

FIGS. 8L-1to8L-3illustrate various views of a head support and camera mount assembly3000according to another embodiment of the present invention. As illustrated, the head support and camera mount assembly3000includes a base3002adapted to clamp onto the side of a table or desktop, an upright3004including a chin support3006, and an arm3008that supports an imaging device3010, e.g., camera.

The arm3008includes a pivot joint3007, e.g., integrally formed in one-piece therewith, that allows the arm3008to rotate laterally with respect to the upright3004, e.g., 90 degrees in both directions.

The upright3004may include a telescopic arrangement for height adjustment.

FIG. 8L-2illustrates a housing including first and second housing parts3070,3071, e.g., molded of plastic, for the imaging device3010that cooperate to support a camera3080. As illustrated, the housing parts3070,3071each include a connecting portion3072adapted to connect to the arm3008. Each housing part3070,3071also includes a support3074adapted to support a respective end of a chassis3082that holds the camera3080(seeFIG. 8L-3). A front cover3075is provided to the housing with a viewing window3077for the camera3080to see through. In addition, a removable and/or pivotable cover3076is provided to the housing to access the camera3080, e.g., pivot cover ¼ turn to access camera.

FIGS. 8M-1to8M-3illustrate various views of a head support and camera mount assembly3100according to another embodiment of the present invention. As illustrated, the head support and camera mount assembly3100includes a base3102adapted to clamp onto the side of a table or desktop, an upright3104(e.g., constructed of extruded aluminum) including a chin support3106(e.g., molded silicone), and an arm3108(e.g., constructed of extruded aluminum) that supports an imaging device3110, e.g., camera.

The arm3108is mounted to a pivot joint3107(e.g., cast aluminum or nylon) that allows the arm3108to rotate laterally with respect to the upright3104, e.g., 90 degrees in both directions.

FIG. 8M-3illustrates a section of the upright3104. As illustrated, the upright3104includes a track portion3160that slidably receives a slider3151provided to flange3150(seeFIG. 8M-2). This arrangement allows the flange3150to slide up and down the upright3104for clamping purposes with the base3102.

FIGS. 8N-1to8N-2illustrate various views of a head support and camera mount assembly3200according to another embodiment of the present invention. As illustrated, the head support and camera mount assembly3200includes a base3202adapted to clamp onto the side of a table or desktop, an upright3204including a chin support3206, and an arm3208that supports an imaging device3210, e.g., camera.

The arm3208is mounted to a pivot joint3207that allows the arm3208to rotate laterally with respect to the upright3204, e.g., 90 degrees in both directions. In addition, the pivot joint3207includes a hinge region that allows the arm3208to rotate up and down between an in-use configuration (solid lines inFIG. 8N-2) and a collapsed configuration (dashed lines inFIG. 8N-2).

The upright3204may include a telescopic arrangement to control height adjustment of the upright3204.

FIG. 8N-3illustrates an alternative configuration of the arm3208.

FIG. 8P-1illustrates a head support and camera mount assembly3300according to another embodiment of the present invention. As illustrated, the head support and camera mount assembly3300includes a base3302adapted to clamp onto the side of a table or desktop, an upright3304including a chin support3306, and an arm3308that supports an imaging device3310, e.g., camera.

The arm3308is mounted to a hinge3307provided to the upright3304that allows the arm3308to rotate laterally with respect to the upright3304, e.g., 90 degrees in both directions.

The upright3304may include a telescopic arrangement to control height adjustment of the upright3304.

FIG. 8Q-1illustrates a head support and camera mount assembly3400according to another embodiment of the present invention. As illustrated, the head support and camera mount assembly3400includes a base3402adapted to clamp onto the side of a table or desktop, an upright3404including a chin support3406, and an arm3408that supports an imaging device3410, e.g., camera.

The arm3408includes a pivot joint3407, e.g., integrally formed in one-piece therewith, that allows the arm3408to rotate laterally with respect to the upright3404, e.g., 90 degrees in both directions.

FIG. 8R-1illustrates a head support and camera mount assembly3500according to another embodiment of the present invention. As illustrated, the head support and camera mount assembly3500includes a base3502adapted to clamp onto the side of a table or desktop, an upright3504including a chin support3506, and an arm3508that supports an imaging device3510, e.g., camera.

The arm3508is pivotally mounted to a joint3507that allows the arm3508to rotate up and down between an in-use configuration and a collapsed configuration.

Also, the upright3504includes a telescopic pneumatic system3511, e.g., gas lift, to control height adjustment of the upright3504.

FIG. 8S-1illustrates an alternative embodiment of a chin support3606provided to an upright3604of a head support and camera mount assembly. As illustrated, the chin support3606includes a ball and socket joint. Specifically, the chin support3606includes a first part3690with a rounded end that fits into a cup-shape socket of a second part3692. The first part3690provides a chin rest and the second part3690is provided to the upright3604.

3.2.18 Eighteenth Alternative Embodiment

FIGS. 8T-1to8T-3illustrate various views of a head support and camera mount assembly3700according to another embodiment of the present invention. As illustrated, the head support and camera mount assembly3700includes a base3702adapted to clamp onto the side of a table or desktop, an upright3704including a chin support3706, and an arm3708that supports an imaging device3710, e.g., camera.

The arm3708is mounted to a pivot joint3707that allows the arm3708to rotate laterally with respect to the upright3704, e.g., 90 degrees in both directions. In addition, the pivot joint3707includes a hinge region3709that allows the arm3708to rotate up and down between an in-use configuration and a collapsed configuration.FIG. 8T-3illustrates alternative embodiments of the pivot joint3707and the hinge region3709adapted to connect to the arm3708.

The upright3704may include a telescopic arrangement to control height adjustment of the upright3704.

FIGS. 8T-2illustrate various sections of the assembly3700to show hollow portions for guiding and/or managing cables, e.g., cables associated with the imaging device3710.

3.2.19 Nineteenth Alternative Embodiment

FIGS. 8U-1to8U-3illustrate various views of a head support and camera mount assembly3800according to another embodiment of the present invention. As illustrated, the head support and camera mount assembly3800includes a base3802adapted to clamp onto the side of a table or desktop, an upright3804including a chin support3806, and an arm3808that supports an imaging device3810, e.g., camera.

The arm3808is mounted to a hinge3807provided to the upright3904that allows the arm3808to rotate laterally with respect to the upright3804, e.g., between 3 positions.

3.2.20 Alternative Base Embodiments

FIGS. 8V-1to8V-10illustrate alternative embodiments of a base adapted to clamp a head support and camera mount assembly onto the side of a table or desktop. For example, the base may include a G-clamp such as that shown inFIGS. 8V-6or8V-7, a cam arrangement such as that shown inFIGS. 8V-1,8V-5, or8V-8, a slide arrangement such as that shown inFIG. 8V-9, or a pivot arrangement such as that shown inFIGS. 8V-2or8V-10.

3.2.21 Alternative Upright Embodiments for Height Adjustment

FIGS. 8W-1to8W-9illustrate alternative embodiments of an upright for a head support and camera mount assembly that allows height adjustment. For example, the upright may include a counterweight arrangement as shown inFIG. 8W-1, a pneumatic system, e.g., gas lift, as shown inFIG. 8W-2, a telescopic arrangement with a threaded knob lock as shown inFIG. 8W-3, a telescopic arrangement with a cam lock as shown inFIG. 8W-4, a telescopic arrangement with a collar lock as shown inFIG. 8W-S, a rack and pinion arrangement as shown inFIG. 8W-6, incremental slot arrangement as shown inFIG. 8W-7, a telescopic arrangement with a spring-loaded pin lock as shown inFIG. 8W-8, or a telescopic arrangement with an expanding lock as shown inFIG. 8W-9.

FIG. 8Xillustrates an embodiment of a bushing3995for use with an upright having a telescopic arrangement. As illustrated, the bushing3995is positioned to prevent the patient from squashing his/her finger between first and second telescoping parts3950,3952.

3.2.23 Assembly Support Embodiment

FIGS. 8Y-1to8Y-2illustrate a support4001that may be used in lieu of the clamp-type bases described above to support a head support and camera mount assembly on the table or ground. For example, the support4001may be adapted to connect to the upright of the assembly.

4. Custom Mask Fitting

With the above system, the selection of a mask system can be very rapid. Moreover, with a wider range of mask systems, a better fit can be obtained for each patient, even those with unusual facial shapes.

The system is also advantageous in that new mask systems can be entered into the mask system database2. This is advantageous as each patient or clinician is not required to learn or even know about each new mask, and which patients to which the new mask system is particularly suited.

This will allow clinicians to concentrate on person-to-person interactions and medical treatment, rather than struggling with measurement of the patient's dimensions, etc. The ability of the physician or clinician to introduce and recommend new products would entail better care of the patients. Moreover, patients who are fitted with the best possible mask system are more likely to use such mask system, which increases patient compliance and effectiveness of treatment.

In some applications, scaling may be required so that the dimensions are accurately entered into the system. Scaling can be achieved, for example, by a patient holding a ruler or other calibration device in the image when the frontal and/or profile views are taken. For example, the head supporting template could be provided with a built in calibration or scaling device, easily visible by the reader, e.g., scanner, camera, etc. The system can then process the image, in part by taking into account the information provided by the scaling device, e.g., a ruler or standard length. In another form, scaling can be achieved by utilizing the known focal length and/or field of view of the camera, or by clicking on a standard length scale (e.g., a ruler).

In another embodiment, the relevant dimensions of the patient's head can be automatically processed by the system, without the need for the clinician or patient to “click” on the points described above in relation toFIGS. 6-7B. In this system, the clinician or patient need only know how to operate a reader or an imaging device such as a webcam or digital camera. For example, the detection of facial features can be obtained using algorithms that typically use neural networks. “See Storm” offers a package that detects features in the frontal image, which package is commercially available. Also, major airport security systems employ facial recognition systems/software which may automatically analyze and output desired fit dimensions, without user needing to click dimensions, thereby eliminating steps in the imaging process.

In yet another alternative, a three-dimensional modeling technique is used to determine the mask that will best fit the patient. The system would use a three-dimensional requisition device to capture a 3D model of the patient's face. The model of the mask system is then “placed” against the model of the patient, electronically speaking, and a best fit is determined based on the minimized gap between the mask and the patient.

In yet another alterative, the 3D modeling technique may also take into account skin texture and firmness. Once a mask fit is found, e.g., based on the above 3D model technique for determining mask systems with minimized gap(s) between the mask system and the patient, the software will then perform an analysis for leaks and pressure at certain points around the cushion to determine the mask size that will provide maximum comfort. Fully automated facial scanners are commercially available from Cyberware. In addition, handheld three-dimensional laser scanning devices are also commercially available. In general, both contact and non-contact imaging systems are contemplated. An example of a contact system is a multitude of pins that are slidable on a base, and which can take the impression of a patient's features.

5. Custom Mask Fitting—Partial Fits and/or Custom Component Selection

Although the above techniques include the selection of an entire mask system, similar principals can be used to select only components thereof, such as headgear, mask cushions, etc. Moreover, such information can be used to select an off-the-shelf mask system, as well as create a custom made patient interface (e.g., cushion) to replace the standard cushion provided with the mask system. Several methods for creating customized masks are described below.

A patient's face deforms when it is subjected to a load. For a mask to achieve the best sealing performance the contour of the mask should match the surface that it is sealing against. To develop a customized mask for a patient the shape of the mask should match the contour of the comfortable facial deformation of the patient.

In order to find the comfortable facial deformation of the patient, a standard nasal or full face mask cushion outline can be applied. As shown inFIG. 9B, this outline is constrained in the x-y directions according to the standard cushion profiles, however, it is variable in the z direction.

When subjected to a set pressure the outline deforms in the z direction according to the facial elasticity of each individual patient. This pressure should be equal to or exceed that required for sealing and not exceed that which is comfortable for a patient. The pressure can be produced either by a cushion or by point loads, which are controlled either by mass or a spring constant.FIGS. 9A,10and10A show a mask membrane100and underlying cushion applied to a face. Using this outline, the stylus102can then be run over either the valley of the cushion (FIG. 10) or the ridge (FIG. 10C) in order to capture the variation in the z direction data.

A further embodiment using a cushion utilizes a deformable material that changes shape when pressure is applied. The material is fitted to a standard mask frame and again has x-y dimensions matching that of standard nasal or full-face mask cushions. The frame and cushion is applied to the face at which point the deformable material varies in the z direction according to the facial elasticity of the patient. Once the frame is removed from the face, the z contour can be traced by a stylus or otherwise captured using scanning or other data capturing methods. Suitable materials include but are not limited to gel, silicone, foam or other plastic materials.

An alternative embodiment using point loads is shown inFIG. 11A. This includes a series of point loads (masses)101of which are mounted on rods103according to the preferred mask cushion outline in the directions x-y. Rods103are slidable on a frame105. When fully extended as shown inFIG. 11A, the point loads have a uniform displacement in z.

In order to apply the mass loads uniformly (due to gravity), the patient should lie on his or her back. While this may lead to some additional set-up effort, it simulates the real-life bed situation and allows for the relaxation of muscle tissue with gravity. Once the patient is comfortable, the support is moved towards the patient until all masses are resting on the patient's face, seeFIG. 11B. The patient's contour can now be traced from the protruding rods using a stylus, photographic means, scanning or other data capturing methods.

A further embodiment of the system can be set up using pre-loaded springs or a measurement of central contour points, seeFIG. 11C. Such a method would not rely on the patient lying down.

An advantage of the above described systems is that they can be used on numerous patients, with only the data being sent to the mask fitting system or mask manufacturing base for conversion into a custom mask. Note, these systems as described relate only to changes in the z direction, however, similar systems can be utilized to capture data in the x and y directions providing a full knowledge of the patient geometry or completely customized cushions.

Specifically, in certain example embodiments, a cushion of translatable pins may be used for 3D modeling and to determine facial make-up. Such systems may function similarly to those described above, though they may record data with respect to x, y, and z coordinates to generate a 3D contour of the patient's face.FIG. 11Dis a flowchart of an example process for generating a 3D model of a patient's face using a cushion of translatable pins. As noted above, it is advantageous for a patient to lie down to apply the mass loads from the pins uniformly. Accordingly, in step S1102, the patient lies down. A cushion is placed over the patient's face in step S1104.

Measurements are taken in step S1106. Measurements may be taken by using a system akin to that shown inFIG. 11B. As such, point loads101would come into contact with the patient's face. Rods103may be operably connected to controller24, which may generate a contour of the patient face (as in step S1108). The contour may be generated by measuring, for example, the depths of rods103relative to frame105, associating the x-y position of each rod to a depth relative to frame105(or some other plane), etc. It will be appreciated that the cushion of pins may take measurements of the patient's face from frontal and/or profile views. As noted above, it is preferable to have the patient lying down. However, any angles can be used to generate the contour of the patient's face if mathematical transforms are applied to the captured data. In some cases, additional data may need to be extrapolated to complete the contour if the positioning of the cushion is greatly askew. This can be corrected, for example, by assuming some level of symmetry and completing the contour accordingly.

It will be appreciated that the resolution of the contour of the patient's face may be influenced by, for example, the number of pins in the cushion. Generally, more pins in the cushion will translate to a higher resolution. It also will be appreciated that data relating to the contour of the patient's face may be interpolated from a coarse measurement. Taking a coarse measurement may provide sufficient data, as an exact topography may not be necessary in all cases. Furthermore, it may be advantageous to have a higher resolution and/or concentration of pins in certain areas that are particularly sensitive (e.g. nose and mouth) while such a high resolution is not necessary at other locations (e.g. forehead). Thus, using these methods, it may be possible to use a cushion of translatable pins as a subcutaneous scanning technique to determine facial make-up and generate a corresponding 3D model. A mask suited for the patient may be recommended based on this information, and the contour and/or the recommended mask may be displayed.

The patient's nasal area is scanned or traced with the laser/stylus and the resulting contour106(FIG. 12A) is used to develop customized nasal prongs. The direction of the prongs is also modified so that the airflow is placed in a direction that flows in alignment with the start of the nasal passage.FIG. 12Bis a laser image of a patient's nose, e.g., the nares.

A mask suited for the patient may be recommended based on this information, according to the example process shown inFIG. 12C. InFIG. 12C, a contour of the patient's nose is generated. It may be generated, for example, by scanning the nasal area with a laser, tracing it with a stylus, etc. It will be appreciated that any sensor capable of generating a signal (preferably digital) corresponding to the contour of the nasal area may be used. It also will be appreciated that areas beyond the mere nasal area may be sensed. Nasal prongs suited for the patient are determined in step S1204. Then, in step S1206, the direction of the prongs may be modified so that the flow of air corresponds with the start of the nasal passage. Based at least on all of this information, a mask may be recommended to the patient in step S1208. The contour and/or the recommended mask also may be displayed

It also may be possible to use a shadow stereopsis sensor as a subcutaneous scanning technique to determine facial make-up and to generate a corresponding 3D model of a patient's face. In general, stereopsis is a process in visual perception leading to perception of the depth or distance of objects. An object's shadow may provide information relating to spatial relationships and depth. Specifically, shadows caused by one object are a source of information for spatial position, location, and depth relations. For example, the gap between an object and its shadow may indicate the object's height relative to a plane, and the location of a shadow on the plane may be indicative of the object's distance and location.

Thus, a shadow stereopsis sensor may be used to develop a 3D map of a patient's face using, for example, the illustrative system shown inFIG. 12D. One preferred embodiment uses two spaced apart light sources1202a-b. These light sources1202a-bcreate shadows on the patient's face1204, which may be detected by a sensor1206. A processor1208may interpret the data (e.g. presence/absence of shadow, shade of shadow, etc.) from a sensor and generate a 3D map from the sensor's data. A controller1210may coordinate the shining of light, sensing, and processing steps. A mask suited for the patient may be recommended based on this information, and the contour and/or the recommended mask may be displayed.

6. Example Mask Selection Processes and Algorithms

FIG. 13illustrates a process900for mask system selection according to an embodiment of the present invention. In step902, patient data is scanned or read at a terminal. Alternatively, the patient data can be simply input into the terminal. In step904, at least a portion of the patient data is communicated to a mask system database. In step906, mask system data is compared to patient data to produce a best-fit mask system signal or result. In step908, the best-fit mask system signal/result is communicated to the terminal.

FIG. 14illustrates a process1000for operation of terminal6. In step1002, patient data is received into the terminal. In step1004, at least a portion of the patent data is communicated to a mask system database. In step1006, a best-fit mask result is displayed at the terminal in accordance with a comparison of patient data and mask system data of the mask system database.

FIG. 15illustrates a process1100for operating a mask system database. In step1102, mask system data is stored for a plurality of mask systems. In step1104, patient data is received from a terminal. In step1106, a best-fit mask system result or signal is generated based on a comparison of the patient data and mask system data.

FIGS. 16 and 17are sample flowcharts.FIG. 16is based on mask type whileFIG. 17is based on mask size.FIGS. 16 and 17show the process of how clinician input and designer input are captured in a sample method of weighting of the questions, and a sample method of weighting of the dimensions, respectively. The weighting of dimensions provides data for analytically describing ‘goodness of fit.’ Stated differently, the way in which data is produced conveniently provides the designer's expertise to the possibly inexperienced clinician fitting the mask. This may provide one or more of the following improvements to the known processes, such as fitting templates, descriptions in the user manual, etc.Improved consistency of fitReduced fitting timeReduced requirement of trial and errorReduced reliance on clinician trainingDirect incorporation of designers knowledge to the fitting method.

The flowcharts ofFIGS. 13-17, or portions thereof, can be programmed onto a machine-readable recording medium, e.g., a compact or floppy disk, memory etc., that includes a control program for controlling a data processor, e.g., controllers14(FIG. 2) or24(FIG. 3). Moreover, upgrades at terminal6may be initiated by sending such recording medium to the terminals. Alternatively, or in addition, upgrades to the control program can be sent electronically to the terminals.

As shown inFIG. 1, the mask fitting system1is preferably implemented on a programmed general purpose computer. A processor associated with such a general purpose computer may be operable to generate and interpret signals from sensors, imaging devices, or the like; perform mathematical operations; control a computerized questionnaire; look up data from a database; generate a display; etc. It will be appreciated that the term processor is used in a generic sense, and any control mechanism comprising any combination of hardware, software, firmware, or the like may be used. It also will be appreciated that such a processor may be operable with any of the techniques for mask fitting described herein (e.g. picture and/or video imaging, contact cushion contouring, nasal cannular scans, shadow stereopsis sensors, combinations thereof, etc.). The mask fitting system (or its subcomponents) can also be implemented on a special purpose computer, a programmed microprocessor or microcontroller and peripheral integrated circuit elements, an ASIC or other integrated circuit, a digital signal processor, a hardwired electronic or logic circuit such as a discrete element circuit, a programmable logic device such as a PLD, PLA, FPGA or PAL, or the like. In general, any device, capable of implementing a finite state machine that is in turn capable of implementing the described systems, methods and the flowcharts shown inFIGS. 13-17, can be used to implement the mask fitting system.

In an embodiment, the mask fitting system may be automated (e.g., by servo motors) so that so that the whole process or parts of the process may be automated. The mask fitting system may be “plug and play” and both the mechanical components and software may do the job for the clinician or provide recommendations for review by the clinician.

A mask fitting algorithm is provided on-line. See the “CPAP Mask Sizing Guide” from the cpap.com website.

In addition, while the invention has particular application to patients who suffer from OSA, it is to be appreciated that patients who suffer from other illnesses (e.g., congestive heart failure, diabetes, morbid obesity, stroke, barriatric surgery, etc.) can derive benefit from the above teachings. Moreover, the above teachings have applicability with patients and non-patients alike in nonmedical applications.