U.S. patent application number 14/102370 was filed with the patent office on 2016-12-15 for customized medical devices and apparel.
This patent application is currently assigned to MetaMason, Inc.. The applicant listed for this patent is MetaMason, Inc.. Invention is credited to Leslie Oliver Karpas, Robert William Moore.
Application Number | 20160361511 14/102370 |
Document ID | / |
Family ID | 52426960 |
Filed Date | 2016-12-15 |
United States Patent
Application |
20160361511 |
Kind Code |
A9 |
Karpas; Leslie Oliver ; et
al. |
December 15, 2016 |
CUSTOMIZED MEDICAL DEVICES AND APPAREL
Abstract
Systems and methods for making a custom sleep apnea mask or
other wearable article are disclosed. The sleep apnea system
comprises a face mask, a headband integrally connected to the face
mask, and at least one air duct configured to direct air from the
CPAP machine to nasal tubes. The face mask preferably comprises: an
inner surface having the same shape as the user's face; an upper
surface configured to sit at a first predetermined distance between
the user's nose and eyes; and an outer surface configured to extend
a second predetermined distance from the inner surface. Nearly
shape and position of substantially all the surfaces of the mask
are configured based on the shape and or location of facial
features, resulting in a highly customized mask optimized for each
individual patient.
Inventors: |
Karpas; Leslie Oliver;
(Pasadena, CA) ; Moore; Robert William;
(Sandhurst, GB) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
MetaMason, Inc. |
Pasadena |
CA |
US |
|
|
Assignee: |
MetaMason, Inc.
Pasadena
CA
|
Prior
Publication: |
|
Document Identifier |
Publication Date |
|
US 20150157822 A1 |
June 11, 2015 |
|
|
Family ID: |
52426960 |
Appl. No.: |
14/102370 |
Filed: |
December 10, 2013 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
61861376 |
Aug 1, 2013 |
|
|
|
61828618 |
Jun 17, 2013 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61M 16/0683 20130101;
A61M 2016/0661 20130101; G06F 30/00 20200101; B29K 2995/0062
20130101; A61M 2207/00 20130101; B29K 2995/0059 20130101; B33Y
50/02 20141201; A61M 16/0816 20130101; B29C 64/386 20170801; B33Y
80/00 20141201; B29C 64/106 20170801; G06K 9/0061 20130101; B29C
64/40 20170801; G06T 17/00 20130101; A61M 16/0875 20130101; B33Y
10/00 20141201; A61M 16/0605 20140204; G06K 9/00281 20130101; B29C
33/52 20130101; A61M 16/0666 20130101; B29K 2101/12 20130101 |
International
Class: |
A61M 16/06 20060101
A61M016/06; G06F 17/50 20060101 G06F017/50 |
Claims
1. A method of making a custom sleep apnea mask configured to
operate with a CPAP machine, the method comprising: scanning at
least a portion of a user's face; generating a surface model of the
user's face; identifying a set of facial features from the surface
model, the set comprising: a) a first point corresponding to the
user's nose, and b) a second point corresponding to the user's
lips; generating a first contour on the surface model based on the
first point; generating a second contour on the surface model based
on the second point; generating a third contour interposed between
the first and second contours, wherein the third line extends
beyond the nose a determined offset; generating an outer surface of
the mask, wherein the outer surface comprises the first, second,
and third contours; and generating an inner surface of the mask,
wherein the inner surface comprises at least a portion of the
surface model between the first and second contours.
2. The method of claim 1, wherein the method further comprises:
providing a surface model of a head; combining the surface model of
the user's face with the surface model of the head; and generating
an inner surface of the mask based on the combination of the
surface model of the user's face with the surface model of the
head.
3. The method of claim 1, wherein generating the third contour
comprises: averaging the first contour and the second contour;
adding a lateral offset in a direction away from the user's face;
and low-pass filtering.
4. The method of claim 1, further comprising: generating a surface
model of nasal tubes; orientating the surface model of the nasal
tubes based on at least the first point; and combining the surface
model of the nasal tubes with the inner surface of the mask.
5. The method of claim 1, wherein identifying a set of facial
features from the surface model further comprises: identifying a
tip of the nose, a bridge of a nose between eyes, an upper-most
point of a set of lips, an underside of a nose, a width of a face,
and a center points of two nostrils.
6. A method of making a custom-fit article for a user, the method
comprising: scanning at least a portion of a user's body;
generating a surface model of the portion of the user's body;
identifying a plurality of anatomical features from the surface
model; determining a first contour on the surface model based on a
first anatomical feature; determining a second contour on the
surface model based on a second anatomical feature; generating an
outer surface comprising the first and second contours; generating
an inner surface comprising at least a portion of the surface model
between the first and second contours; and combining the outer
surface and inner surface to form a three dimensional volume of the
custom-fit article.
7. A sleep apnea system configured to operate with a CPAP machine,
the sleep apnea system comprising: a face mask comprising: a) an
inner surface configured to contact a user, wherein the inner
surface has a shape of the user's face; b) an upper surface
configured to sit at a first predetermined distance between the
user's nose and eyes; and c) an outer surface configured to extend
a second predetermined distance from the inner surface; a headband
integrally connected to the face mask; at least one air duct
configured to direct air from the CPAP machine to the nasal
tubes.
8. The sleep apnea device of claim 7, further comprising a pliable
coupling configured to: detachably attach to the CPAP machine, and
attach to the at least one air duct.
9. The sleep apnea device of claim 7, wherein the face mask further
comprises a plurality of nasal tubes, the nasal tubes having an
orientation determined based on scan data of the user.
10. The sleep apnea device of claim 7, wherein the at least one air
duct is an internal duct embedded in the headband.
11. The sleep apnea device of claim 7, wherein the at least one air
duct comprises an external duct connected to the headband.
12. The sleep apnea device of claim 11, wherein the external duct
comprises a plurality of flexible tubes.
13. The sleep apnea device of claim 7, wherein the headband
comprises: a left headband portion; a right headband portion; and
at least one fastener configured to detachably attach the left and
right headband portions.
14. The sleep apnea device of claim 7, wherein the face mask
further includes an enclosure configured to cover a patient's
mouth.
15. The sleep apnea device of claim 14, wherein the enclosure is
configured to provide a pneumatic seal around the patient's
mouth.
16. A custom article prepared by a process comprising the steps of:
providing user scan data corresponding to a first body part, the
user scan data comprising at least one anatomical feature of a
user; providing generic model data corresponding to a second body
part; providing model data corresponding to a first article;
generating a model of the first and second body parts by combining
the user scan data of the first body part with the generic model
data of the second body part; fitting the model data of the first
article to the model of the first and second body parts using the
at least one anatomical feature present in the user scan data of
the first body part; generating a model of a custom article
tailored to the first and second body part by conforming the model
data of the first article to the model of the first and second body
parts; and manufacturing a custom article from the model of the
custom article.
17. The custom article prepared by the process of claim 16, wherein
the scan data corresponding to the first body part is scan data of
a user face, the generic model data of the second portion of the
body part is model data of a head, and the model of the first and
second body parts is a substantially complete model of a head with
the user face.
18. The custom article prepared by a process of claim 17, wherein
the custom article is a sleep apnea mask.
19. The custom article prepared by the process of claim 16, wherein
combining the user scan data of the first body part with the
generic model data of the second body part comprises: aligning the
generic model data of the body part with the user scan data of the
first body part; scaling the generic model data of the second body
part to match the user scan data of the first body part based on
tangency of surfaces represented by the generic model data and the
user scan data.
20. The custom article prepared by the process of claim 19, wherein
tangency of surfaces is a rate of change of curvature at a boundary
between surfaces represented by the generic model data and the user
scan data.
21. The custom article prepared by the process of claim 16, wherein
fitting the model data of the first article to the model of the
first and second body parts comprises: vertically positioning the
model data of the first article relative to the model of the first
and second body parts.
22. The custom article prepared by the process of claim 16, wherein
conforming the model data of the first article to the model of the
first and second body part comprises: Boolean volume subtraction of
the model data of the first article from the model of the first and
second body parts, whereby the model data of the first article is
configured to conform to at least a portion of the first and second
body parts.
23. The custom article prepared by the process of claim 22, wherein
the model data of the first article comprises a first contour and a
second contour; and wherein conforming the model data of the first
article to the model of the first and second body parts comprises:
locating at least one anatomical feature; locating the first
contour on the model of the first and second body parts based on a
first one of said anatomical features; and locating the second
contour on the model of the first and second body parts based on a
second one of said anatomical features.
24. The custom article prepared by the process of claim 16, wherein
conforming the model data of the first article to the model of the
first and second body parts further comprises: generating an outer
surface for the custom article, wherein the outer surface comprises
the first and second contours; and generating an inner surface for
the custom article, wherein the inner surface comprises at least a
portion of the user scan data between the first and second
contours.
Description
CROSS-REFERENCE TO RELATED APPLICATION(S)
[0001] This application claims the benefit of U.S. Provisional
Patent Application Ser. No. 61/861,376 filed Aug. 1, 2013, titled
"CUSTOMIZED MEDICAL DEVICES AND APPAREL," which is hereby
incorporated by reference herein for all purposes.
TECHNICAL FIELD
[0002] The invention relates to the production of medical devices
and apparel that are custom fit to users. In particular, the
invention relates to medical devices and apparel, as well as the
systems and method for making them using three dimensional scan
data of the users.
BACKGROUND
[0003] Millions of people are affected by a disorder called sleep
apnea, which occurs when a person's pattern of breathing is
interrupted while sleeping. People afflicted with this condition
often fail to get enough rest during the night, which leaves them
lethargic during the day. A common treatment for some forms of
sleep apnea include air delivered using a "continuous positive
airway pressure" machine, which delivers air to the patient using a
face mask fitted around the patient's nose or nose and mouth. To be
effective, the mask must be worn while the patient is sleeping. The
mask generally includes plastic and/or rubber components that are
held against the patient's face in order to maintain a pressure
seal. Current sleep apnea masks are designed to accommodate a large
number of patients with a variety of face sizes and dimensions. As
a result, current sleep apnea masks may actually may fit poorly,
provide a weak pressure seal, and be uncomfortable to wear. For
these reasons, there is a need for a sleep apnea mask that is
custom fit to the user in order to provide better functionality and
wearability, both of which increase the probability that the
patient will receive successful treatment over the long term.
SUMMARY
[0004] The invention in the preferred embodiment features a system
and method for making a wearable article such as a custom sleep
apnea mask configured to operate with a CPAP machine. The method
preferably comprises the steps of scanning at least a portion of a
user's face; generating a surface model of the user's face; and
identifying a set of facial features from the surface model. The
facial features generally include a first point corresponding to
the user's nose, and a second point corresponding to the user's
lips. A first contour is generated on the surface model based on
the first point, a second contour is generated on the surface model
based on the second point, and a third contour may be generated at
a position interposed between the first and second contours and
offset from the user's nose. The method further includes generating
an outer surface of the mask comprising the first, second, and
third contours; and generating an inner surface of the mask
comprising the surface model between the first and second contours.
The inner surface and outer surface may be combined to create a 3D
volume of a sleep apnea mask configured to be printed using one of
a plurality of 3D printing machines. In some embodiments, the
surface model of the user's face is combined with a surface model
of a generic head in order to provide a comprehensive data set from
which a full head mask can be generated.
[0005] In another embodiment, the invention features a sleep apnea
system configured to operate with a CPAP machine, wherein the sleep
apnea system comprises a face mask, a headband integrally connected
to the face mask, and at least one air duct configured to direct
air from the CPAP machine to the nasal tubes. The face mask
preferably comprises: an inner surface having the same shape as the
user's face; an upper surface configured to sit at a first
predetermined distance between the user's nose and eyes; and an
outer surface configured to extend a second predetermined distance
from the inner surface. A pliable coupling may be employed to
detachably attach to the CPAP machine, and attach to the at least
one air duct. The duct may take the form of an internal duct
embedded in the headband, or an external duct including flexible
tubes connected to the headband.
[0006] In some embodiments, the invention features a custom article
prepared by a process comprising the steps of: providing user scan
data corresponding to a user face, providing generic model data
corresponding to a part of a head, for example, and providing model
data corresponding to a sleep apnea mask or other article. The
method further includes generating a model of the face and head by
merging the user scan data with the generic model data. Thereafter,
the model data of the sleep apnea mask is fitted to the model of
the face and head based on the location of the user's nose and
mouth or other anatomical features. A model of the mask tailored to
the head is generated by conforming the model data of the mask to
the model of the face and head such that the inside of the mask
conforms or otherwise matches the user's face. The resulting mask
model may then be transmitted to a 3D printer or other
manufacturing process to produce the custom mask. The face and head
are just two of a plurality of different body parts for which user
scan data and generic model data may be acquired and combined to
produce custom medical devices, apparel, or other wearable
article.
BRIEF DESCRIPTION OF THE DRAWINGS
[0007] The present invention is illustrated by way of example and
not limitation in the figures of the accompanying drawings, and in
which:
[0008] FIG. 1 is a network diagram for 3D printing medical devices
and apparel, in accordance with an embodiment of the present
invention;
[0009] FIG. 2 is a flowchart of the method for 3D printing medical
devices and apparel, in accordance with an embodiment of the
present invention;
[0010] FIG. 3 is a functional block diagram of a user interface for
designing and defining custom masks for patients and other users,
in accordance with an embodiment of the present invention;
[0011] FIG. 4 is a functional block diagram of a computational
geometry processor used in the Dynamic 3D Print Design System
(DPDS), in accordance with an embodiment of the present
invention;
[0012] FIGS. 5A-5C are diagrammatic illustrations of patient scan
data, a generic head model, and a model including a combination of
the patient scan data and the generic head model, respectively, in
accordance with an embodiment of the present invention;
[0013] FIGS. 6A-6C are diagrammatic illustrations of a mask model
before volume subtraction, a patient head model, and a mask model
after volume subtraction of the patient head model, respectively,
in accordance with an embodiment of the present invention;
[0014] FIG. 7 is a functional block diagram of a fabrication
geometry processor used in the DPDS, in accordance with an
embodiment of the present invention;
[0015] FIGS. 8A-8F are diagrammatic illustrations depicting the
parametric fitting process for designing a mask, in accordance with
an embodiment of the present invention;
[0016] FIGS. 9A-9B are diagrammatic illustrations depicting the
press fit process for designing a mask, in accordance with an
embodiment of the present invention;
[0017] FIGS. 9C-9D are top down views of a mask before and after a
mask model is press fit to a face, respectively, in accordance with
an embodiment of the present invention;
[0018] FIG. 10A is a perspective view of the front side of a sleep
apnea mask, in accordance with a first embodiment of the present
invention;
[0019] FIG. 10B is a front view of a sleep apnea mask, in
accordance with a first embodiment of the present invention;
[0020] FIG. 10C is a side view of a sleep apnea mask, in accordance
with a first embodiment of the present invention;
[0021] FIG. 10D is a perspective view of the back side of a sleep
apnea mask, in accordance with a first embodiment of the present
invention;
[0022] FIG. 10E is a top view of a sleep apnea mask, in accordance
with a first embodiment of the present invention;
[0023] FIG. 10F is a cross sectional view of a sleep apnea mask, in
accordance with a first embodiment of the present invention;
[0024] FIG. 10G is a cross sectional view of a sleep apnea mask, in
accordance with a first embodiment of the present invention;
[0025] FIG. 10H is a front side view of a face mask, in accordance
with a first embodiment of the present invention;
[0026] FIG. 10J is an exploded view of a sleep apnea mask, in
accordance with a first embodiment of the present invention;
[0027] FIG. 10K is an exploded view of a sleep apnea mask, in
accordance with a first embodiment of the present invention;
[0028] FIGS. 10L-10N are perspective views of a right-side manifold
used in a sleep apnea mask, in accordance with a first embodiment
of the present invention;
[0029] FIG. 11A is a perspective view of the front side of a sleep
apnea mask, in accordance with a second embodiment of the present
invention;
[0030] FIG. 11B is a perspective view of the back side of a sleep
apnea mask, in accordance with a second embodiment of the present
invention;
[0031] FIG. 11C is a perspective view of the front side of a sleep
apnea mask, in accordance with a second embodiment of the present
invention;
[0032] FIG. 11D is a view of the inner side of the face mask of a
sleep apnea mask, in accordance with a second embodiment of the
present invention;
[0033] FIG. 11E is a perspective view of a retainer used in a sleep
apnea mask, in accordance with a second embodiment of the present
invention;
[0034] FIG. 11F is a perspective view of a retainer used in a sleep
apnea mask, in accordance with a second embodiment of the present
invention;
[0035] FIG. 12A is a perspective view of a sleep apnea mask, in
accordance with a third embodiment of the present invention;
[0036] FIG. 12B is a perspective view of the inner side of the face
mask of a sleep apnea mask, in accordance with a third embodiment
of the present invention;
[0037] FIG. 13A is a perspective view of a sleep apnea mask, in
accordance with a fourth embodiment of the present invention;
[0038] FIG. 13B is a front side view of a sleep apnea mask, in
accordance with a fourth embodiment of the present invention;
[0039] FIG. 13D is a back side view of a sleep apnea mask, in
accordance with a fourth embodiment of the present invention;
[0040] FIG. 13E is a perspective view of a sleep apnea mask, in
accordance with a fourth embodiment of the present invention;
[0041] FIG. 13F is a side view of a sleep apnea mask, in accordance
with a fourth embodiment of the present invention;
[0042] FIG. 13G is a top down view of a sleep apnea mask, in
accordance with a fourth embodiment of the present invention;
[0043] FIG. 13H is a cross sectional view of a sleep apnea mask, in
accordance with a fourth embodiment of the present invention;
[0044] FIG. 13I is a cross sectional view of a sleep apnea mask, in
accordance with a fourth embodiment of the present invention;
[0045] FIG. 13J is an exploded view of a sleep apnea mask, in
accordance with a fourth embodiment of the present invention;
[0046] FIG. 14A is a perspective view of a sleep apnea mask, in
accordance with a fifth embodiment of the present invention;
[0047] FIG. 14B is a side view of a sleep apnea mask, in accordance
with a fifth embodiment of the present invention;
[0048] FIG. 14C is a front side view of a sleep apnea mask, in
accordance with a fifth embodiment of the present invention;
[0049] FIG. 14D is a side view of a sleep apnea mask, in accordance
with a fifth embodiment of the present invention;
[0050] FIG. 14E is a back side view of a sleep apnea mask, in
accordance with a fifth embodiment of the present invention;
[0051] FIG. 14F is a top side view of a sleep apnea mask, in
accordance with a fifth embodiment of the present invention;
[0052] FIG. 14G is a cross sectional view of a sleep apnea mask, in
accordance with a fifth embodiment of the present invention;
[0053] FIG. 14H is an exploded view of a sleep apnea mask, in
accordance with a fifth embodiment of the present invention;
[0054] FIG. 15A is a perspective view of a sleep apnea mask, in
accordance with a sixth embodiment of the present invention;
[0055] FIG. 15B is a front side view of a sleep apnea mask, in
accordance with a sixth embodiment of the present invention;
[0056] FIG. 15C is a back side view showing the inner face of a
sleep apnea mask, in accordance with a sixth embodiment of the
present invention;
[0057] FIG. 15D is a cross sectional view of a sleep apnea mask, in
accordance with a sixth embodiment of the present invention;
[0058] FIG. 15E is a top side view of a sleep apnea mask, in
accordance with a sixth embodiment of the present invention;
[0059] FIG. 16A is a front side view of a sleep apnea mask, in
accordance with a seventh embodiment of the present invention;
[0060] FIG. 16B is a back side perspective view of a sleep apnea
mask, in accordance with a seventh embodiment of the present
invention;
[0061] FIG. 16C is an exploded view of a sleep apnea mask, in
accordance with a seventh embodiment of the present invention;
[0062] FIG. 16D is a top side perspective view of a sleep apnea
mask, in accordance with a seventh embodiment of the present
invention;
[0063] FIG. 16E are various views of a valve insert used in a sleep
apnea mask, in accordance with a seventh embodiment of the present
invention;
[0064] FIG. 16F are various views of a valve retainer used in a
sleep apnea mask, in accordance with a seventh embodiment of the
present invention;
[0065] FIG. 16G is a cross sectional view of a nasal tube used in a
sleep apnea mask, in accordance with a seventh embodiment of the
present invention;
[0066] FIG. 17A is a front side perspective view of a CPAP
coupling, in accordance with an embodiment of the present
invention;
[0067] FIG. 17B is a back side perspective view of a CPAP coupling,
in accordance with an embodiment of the present invention;
[0068] FIG. 17C is a cross sectional view of a CPAP coupling, in
accordance with an embodiment of the present invention;
[0069] FIG. 17D is an exploded view of a CPAP coupling, in
accordance with an embodiment of the present invention;
[0070] FIG. 18 is a flowchart of a method of a method of
manufacturing a medical device or article of apparel, in accordance
with a first embodiment;
[0071] FIG. 19 is a flowchart of a method of a method of
manufacturing a medical device or article of apparel, in accordance
with a second embodiment;
[0072] FIGS. 20A-20L are diagrammatic illustrations of the 3D
printing investment casting technique of the preferred
embodiment;
[0073] FIGS. 21A-21M are diagrammatic illustrations showing the 3D
printing investment casting technique used to make a CPAP coupling;
and
[0074] FIGS. 22A-22G are diagrammatic illustrations showing the 3D
printing investment casting technique used to make a running shoe
or other article of apparel.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT
[0075] Illustrated in FIG. 1 is a functional block diagram of a
network for implementing one or more embodiments of the present
invention. The network includes a Dynamic 3D Print Design System
(DPDS) 130 configured to design medical devices and other
body-fitted components customized for individual users. In the
preferred embodiment, the medical device is a sleep apnea mask,
although the DPDS is capable of producing numerous other medical
and non-medical devices including eyewear, goggles, ski masks,
scuba masks, footwear, and other apparel. Each mask is custom
manufactured based on 3D scan data of the patient to ensure a
superior fit and comfort, which, in turn, enhances the
effectiveness of the mask and resulting treatment. The custom-fit
masks are then produced using manufacturing techniques that may
include one or more 3D printers 120-122 or other rapid prototyping
and computer-aided manufacturing techniques that construct objects
layer-by-layer, for example.
[0076] The patient scan data may be acquired using any of a number
of different scanning systems known to those skilled in the art.
Suitable scanning systems may include scanners (from 3D Systems,
Inc. of Rock Hill, S.C., for example) capable of collecting data
points in a three dimensional Euclidean space, for example. In some
embodiments, the patient 112 scan data may be acquired by a
technician 111 using a scanner 110 located in a hospital, clinic,
pharmacy, or retail facility, for example. In other embodiments,
the scan data is acquired by a user 116 himself or herself with a
personal scanning device 114, for example. In the preferred
embodiment, the scan data generally consists of 3D volume data
characterizing the shape, size, and contours of the head and/or
face of the patient in a three dimensional coordinate system such
as a Cartesian, polar, or spherical coordinate system. The scan
data may be represented as raw point cloud data or converted to a
surface model in one of the following forms: non-uniform rational
B-spline (NURB) data, sub-divisional NURBS (aka, sub-dNURBS),
polygonal mesh, and/or combination of parametric definitions.
Common file types for representing scan data include mesh file
types: .mud /.mb / .anim / .iff / .cpp / .fxa / .spt / .c4d / .aec
/ .exr / .mc4d / .3ds / .max / .act / .bip / .cel / .exr / .ztl /
.stl / .ply / .amf; NURBS file types: .lxo / .blend / .blend2 /
.obj / .off / .mdd / .exr / .sdl / .wire / .3dm / .3dx / .ws /
.3dc; and parametric file types: .dgn / .dgr / .rdl / .svf / .dwg /
.dxf / .adsk / .ies / .rvt / .skp / .easm / .dwf / .dwfx / .iam /
.idw / .ipt / .drw/ .dxf / .jt / .lay / .prt / .sec / .slp / .stl /
.drw / .dxf / .jt / .lay / .prt / .sec / .slp / .3dmap / .3dxml /
.c18 / .catpart / .catshape / .model / .sldprt / .sldasm / .tso /
.xli / .scdoc / .ad_prt.
[0077] The patient scan data is then provided to and processed by
the DPDS 130 to generate a medical device for the patient.
Depending on the application, the DPDS 130 may be co-located with
the scanner, or remotely located at a separate facility accessible
via the Internet 102. In the preferred embodiment, the DPDS 130
includes a product interface 132, computational geometry processor
134, fabrication controller 136, and scan data database 138. The
product interface 132 is generally used to select and define one of
a plurality of medical devices or components to be generated from
the patient's scan data. The computational geometry processor (CGP)
134 is configured cleanse the scan data of artifacts, fit a generic
model of the selected medical device to the scan data, and generate
a unique model of the selected mask custom fit to the individual
patient. The fabrication geometry processor (FGP) 136 then converts
the data representing the custom mask into one or more ".STL" files
and/or other manufacturing instructions tailored to the one or more
3D printers 120-122 selected/employed to manufacture the custom
mask for the patient. In some embodiments, the DPDS 130 further
includes a biodata interface 140 configured to utilize a patient's
personal biological or physiological data 140 to alter the size,
shape, or features of the patient's mask and/or the mask's
functionality.
[0078] Illustrated in FIG. 2 is a flowchart of the process of
generating a custom-fit sleep apnea mask or other medical device.
After a 3D scan of the patient's face and/or head is acquired 210,
one of a plurality of mask types is selected 212 along with any
applicable design features or customization. The selected mask type
is associated with and used to retrieve a digital model of a mask.
The mask model is then fitted 214 to or intersected with the
patient scan data in order to produce a new mask model that is
compliant with the patient's facial features. The resulting mask
will, therefore, provide a reliable pneumatic seal with maximal
comfort. Using the mask model modified for the patient, one or more
data files and computer instructions are generated 216 and used to
construct or otherwise fabricate 218 the custom-fit mask for the
patient.
[0079] Illustrated in FIG. 3 is the product interface in accordance
with the preferred embodiment of the DPDS 130 shown in FIG. 1. The
product interface 132 includes a mask selection processor 310 that
enables a technician or other operator to view and select a
suitable sleep apnea mask from a plurality of mask options,
including, for example, (1) a nasal mask configured to
operationally attach to and receive air from a continuous positive
airway pressure (CPAP) machine, (2) a mask fitted for the mouth and
nose with a CPAP attachment, (3) a mask with nasal tubes and CPAP
attachment, and (4) a mask with nasal tubes and valves. The masks
with a CPAP attachment generally include a coupling and one or more
integrated air ducts for connecting the sleep apnea device to the
pressurized CPAP output. In some embodiments, these one or more air
ducts include ducts either embedded into the mask or sets of
elastic tubes routed external to a mask headband.
[0080] The tube selection processor 320 is then used to choose
between the embedded or external ducting option if available. The
pneumatic coupling selection 330 enables the technician to select
from a plurality of attachment mechanisms used to directly connect
the CPAP output tube and mask. The attachment mechanisms generally
include different couplings corresponding to different sizes,
shapes, and locations on the patient's head. The patient fitting
processor 340 enables the technician to adjust the mask model in
order to better fit it to the patient. Although this fitting
process is done automatically in the preferred embodiment, the
interface 132 may enable the technician to manually adjust the size
of the mask and headband, for example, to reduce pressure on the
patient's face or head, or adjust the mask and headband to account
for the position in which the patient sleeps. The location of the
headband may also be adjusted in order to avoid interfering with
the patient's eyes or ears, for example. In the module for
attachment selection 350, the technician can modify the mask model
to include alternate mechanisms to affix the mask to the patient
including, for example, one or more magnets or shape changing alloy
may be inserted into the mask to generate a force that biases the
mask against the patient's face. Using a customization processor
360, the model of the selected mask may be modified to include
aesthetic and stylistic design features including colors, patterns,
graphics, and embossing, for example.
[0081] In some embodiments, the product interface further includes
a processor 370 for customizing the mask based on personal
diagnostic metrics (PDM). PDMs may include the airflow capacity of
the patient's esophagus and nasal cavity (determined with magnetic
resonance imaging (MRI) scan data or x-ray scan data, e.g.), which
may be used to determine the optimal size and shape of the air
ducts in the sleep apnea mask. If a patient has difficulty
breathing due to a blocked nasal passage, for example, the air
passages in the sleep apnea mask may be enlarged to provide maximal
air flow, thereby compensating for the patient's physical
condition.
[0082] Illustrated in FIG. 4 is the computational geometry
processor (CGP) 134 in accordance with the preferred embodiment of
the DPDS 130 shown in FIG. 1. The CGP 134 is configured to receive
the mask model from the product interface 132 as well as the
patient scan data. Prior to merging the mask model and the scan
data, artifacts are identified and removed from the scan data using
an artifact removal module 410. A significant source of artifacts
is a patient's hair which does not scan well, resulting in gaps and
erroneous scan points in the data set. The CGP 134 further includes
a manifold integrity processor 420 which is configured to convert
the patient scan data to a manifold surface, if not already, and
then remove any holes or apertures in the manifold that might
prevent or interfere with the production of the mask model or 3D
print operation.
[0083] In some embodiments, the patient scan data consists of a
manifold representing the face, which generally includes the region
from the forehead to the chin and from ear to ear. Depending on the
embodiment, scan data representing the face alone may be
insufficient to make a sleep apnea mask with compliant head strap
or headband. To address this incomplete data set, the CGP 134
includes a processor 430 configured to merge the face data together
with a generic model of a head to produce a model of the complete
patient head. The process of merging or otherwise combining face
data and head data is shown schematically in FIGS. 5A-5C. In the
preferred embodiment, the face data is represented as a 2D surface
shown in FIG. 5A, and a generic model of a head shown in FIG. 5B.
The head data and/or face scan data are then scaled, rotated,
stretched, smoothed, or otherwise morphed to merge the head data
with the face data. The transitions between the face data and head
model should be proportionate and smooth and continuous at the
boundaries. Any gaps between the face manifold and head manifold
may be filled using one of multiple surfacing techniques known to
those skilled in the art including lofting, for example. The result
is a single manifold surface including face and head representing
the individual patient's complete head, as shown in FIG. 5C.
Although the preferred embodiment employs morphing and lofting
techniques, one skilled in the art will appreciate that there are
other techniques for generating a model of a complete head using
scan data representing the face alone.
[0084] In some embodiments, the head data to be merged with the
face data is selected from a plurality of different generic head
models. A database with a plurality of generic head models may be
compiled in order to provide a selection of models with which to
represent people of different body shapes and proportions. Models
of heads may be selected for patients based on each patient's
ancestry, gender, age, weight, and face dimensions/aspect ratio,
for example. Candidate head models may be tested and the optimum
model identified and merged with the face data. In the preferred
embodiment, the optimum head model yields the least geometric
error, that is, the head model that provides maximal tangency
between the head data and face data. Maximal tangency corresponds
to a minimum rate of change in curvature at the boundary between
the surface of the head data and face data, averaged over the
entire boundary.
[0085] Thereafter, a feature identification processor 440 locates
one or more anatomical features--e.g., eyes, nose, mouth, and
ears--in the model of the patient head. The identified features
serve as control points for purposes of automatically aligning,
registering, fitting, shaping, and/or designing the customized mask
model without the aid of an operator. After the mask model is
designed, however, the control point fitting processor 450 is
configured to enable an operator to subsequently adjust the size,
position, and/or orientation of the mask to fit over the mouth
and/or nose, or adjust the position of straps or external air ducts
(if present) around the patient's cheeks and above the patient's
ears, for example.
[0086] In one preferred embodiment, the model of the mask is
designed using a technique referred to as "Boolean volume
subtraction," which is illustrated in FIGS. 6A-6C. In the volume
subtraction technique, a 3D model of a mask and 3D volume of the
patient's head are superimposed and a portion of the mask
subtracted away from the mask model. In particular the 3D mask
model 510 in FIG. 6A is made to extend or protrude into the
interior space of the model 520 of the head in FIG. 6B so that the
two models are overlapping in the region of the face and straps.
Once the mask and patient scan data are aligned, a compliance
determination processor 460 subtracts the portion of the mask model
that intrudes into the interior of the model of the head. The
remaining portion of the mask 530 is thus a custom mask having an
inner surface that exactly matches and conforms to the patient's
face. Because each patient is unique, each mask model is therefore
also unique. Other techniques for designing the custom-fit mask are
discussed in context of FIGS. 8A-8F as well as 9A-9D.
[0087] Illustrated in FIG. 7 is the fabrication geometry processor
(FGP) 136 in accordance with the preferred embodiment of the DPDS
130 shown in FIG. 1. Using the FGP 136, a technician selects a
manufacturing system or technique for one or more components of the
sleep apnea mask. The technique may involve direct 3D printing of
one or more mask components, and/or 3D printing of a mold from
which one or more mask components are cast. As shown, the user can
choose to construct the portion of the mask or mold using, for
example, stereolithography (SLA) 720, fused deposition modeling
(FDM) 730, fused filament fabrication (FFF), starch-based printing
system 740, selective laser sintering (SLS) 750, additive
manufacturing techniques like POLYJET.TM. printing 760,
and/ENVISION TEC.TM. 3D printing. Once the manufacturing
methodologies are selected, the FGP 136 converts the custom mask
model into one or more print files, manufacturing instructions,
and/or assembly instructions specific to the selected 3D printer or
printers. This generally involves generating one or more ".STL"
files from the parametric solids, mesh, or non-uniform rational
B-spines (NURBS) data models.
[0088] In addition to the "Boolean volume subtraction" technique
discussed above, the custom-fit mask may be designed using various
other techniques including (a) a "NURBS subtraction" technique, (b)
a "parametric fitting" design technique illustrated in FIGS. 8A-8F,
and (c) a "press fit" design technique illustrated in FIGS. 9A-9D.
In the "NURBS subtraction" technique, the compliance determination
processor 460 converts the patient model (including the combination
of face data and head data) from a mesh model to a non-uniform
rational basis spline (NURBS) model. The model of the mask, which
is also represented as a NURBS, is super-imposed with the NURBS
patient model. As discussed above, the size, position, and
proportions of the mask may be adjusted, as needed, to account for
anatomical features located by the feature identification processor
440. After the head and mask models are aligned, a compliant
version of the mask model is generated based on the intersection of
the mask NURBS and the patient NURBS. In particular, the portion of
the NURBS of the patient model bounded by the mask model is
identified, and the portion of the NURBS of the mask model lying
outside the patient model is identified. The NURBS of the patient
model is the section of the patient model between the upper edge
and lower edges of the mask where the mask and patient models
intersect. The NURBS of the mask model is the section of the mask
model extending outward from the patient model. Each of the two
portions represent NURBS surfaces which, when combined, form a
NURBS volume representing a compliant mask. The NURBS volume is
then processed by the fabrication geometry processor in the manner
described below.
[0089] In the "parametric fitting" design technique illustrated in
FIGS. 8A-8F, the outer surface of the mask as well as the interior
volume are custom designed for each patient. The current technique
differs from other techniques where only the inner face of the mask
is custom designed for an individual patient. In the present
embodiment, the (a) the inner surface of the mask, (b) the interior
structure of the mask, and (c) the outer surface of the mask are
all custom designed for each patient in order to optimize the fit,
optimize the air flow, and/or minimize the size/material need to
construct the mask, for example. In this parametric fitting
process, points or other features on the users face are located or
otherwise measured in three dimensions and the mask shape
determined relative to those points and/or measurements. The
parametric fitting process insures that the mask conforms to each
patient regardless of the height, width, and overall size the
patient's face, nose, and cheeks, all of which vary widely based on
age, gender, ethnicity, etc.
[0090] In the preferred embodiment, the parametric fitting process
of designing the mask begins with the acquisition of the patient's
3D head model and feature recognition, as described above. Once the
location of the eyes, nose, and mouth are determined, the mask
design system locates the following specific anatomical points in
the patient scan data: (a) tip of the nose 810, (b) bridge of the
nose 812 between the eyes 814, (c) the upper-most point of the lips
816 closest to the nose, (d) the underside of the nose 818 closest
to the upper lip, (e) the width of the face 822, 824, and (f) the
center points of the nostrils 820. In general, these points vary in
location from patient to patient. Using the anatomical points
acquired from the scan data, the mask design system determines the
optimal location of the (a) upper edge of the mask, (b) the shape
of the upper edge of the mask, (c) the bottom edge of the mask, (d)
the shape of the bottom edge of the mask, (e) the height of the
mask off the face across the entire face.
[0091] First, the mask fitting module 450 locates a point about
half way between the tip of the nose and bridge of the nose,
referred to herein as the mid-nose point 830. In the preferred
embodiment, this point is 60% of the distance between the tip and
bridge of the nose as measured from the tip. The mid-nose point
then anchors the upper edge of the mask. Second, a predetermined
curve 832 defining the desired shape of the mask is then fitted
between the mid-nose point and the left side 822 of the face, and
between the mid-nose point and right side of the face as defined by
the facial width measurement. The curves spanning the left and
right sides of the face, which are represented in a single plane,
are then projected directly onto the patient's face scan data. The
intersection of the projection of the curves and the scan data is
represented by a contour in 3D space. This first contour 840
locates the upper edge of the mask.
[0092] Third, the mask system locates a point about half way
between the lips and nose, referred to herein as the philtral
dimple point or just dimple point 834. In the preferred embodiment,
this point is 40% of the distance between the upper tip 816 of the
upper lip to the lower side of the nose as measured from the upper
lip. This dimple point 834 then anchors the lower edge of the mask.
Instead of the dimple point 834, a point below the lips may be
selected to construct a mask that covers both the nose and mouth.
Fourth, a second predetermined curve 836 defining the desired shape
of the mask is then fitted between the dimple nose point and the
left side 824 of the face, and between the dimple point and right
side of the face as defined by the facial width measurement. The
curves spanning the left and right sides of the face, which are
represented in a single plane, are then projected directly onto the
patient's face scan data. The intersection of the projection of the
curves and the scan data is represented by a contour in 3D space.
This second contour 842 locates the lower edge of the mask. The
portion of 3D patient head data between the first contour 840 and
the second contour 842 is illustrated with hashing 841 in FIG.
8C.
[0093] Fifth, a mask offset defining the forward-most edge of the
mask is determined with the aid of a "tween contour" 844 shown in
FIG. 8D. The tween contour is computed by (1) generating a 2D tween
curve by averaging the vertical height of the upper and lower
contours 840,842 described above; (2) generating a 3D tween curve
by projecting the 2D tween curve onto the patient head data to
determine the intersection between the two; (3) generating an
offset tween curve by taking the 3D tween curve coinciding with the
scan data and adding a fixed lateral offset distance in the
direction in front of the face; and (4) generating the final tween
contour 844 by smoothing or otherwise low-pass filtering the offset
tween curve from the middle of the curve to the edges of the curve.
The offset distance can be set to a specific wall thickness, set to
a specific distance beyond the tip of the nose, or varying the
offset in relation to the height of the mask.
[0094] The upper and lower contours 840, 842 along with the final
tween contour 844 are the foundations for a plurality of cross
section curves that are then used to make the outer surface of the
mask. The cross section curves 850 shown in FIG. 8E define the
general cross section at various points along the width of the
mask. At each point along the width, a cross section curve is a
line generated such that it lies in a common plane and intersects
the upper and lower contours 840, 842 as well as the final tween
contour 844. This plane generally projects at substantially a right
angle from the face scan data at the point it intersects the upper
contour. The outer surface 860 of the mask is then produced by
generating a surface that includes each of the cross section
curves.
[0095] In addition to the outer surface 860 of the mask, the upper
and lower contours are also used to determine the inner surface of
the mask. In particular, the upper and lower contours are used to
identify and segment the relevant section of the patient's face
scan data or head data 841 shown with hash marks in FIG. 8C. This
segment of the scan data 841 is then combined with the outer
surface of the mask 850 to generate a closed 3D volume from which
the mask may be printed.
[0096] In some embodiments, the initial shape define by the inner
and outer surfaces then act as a template to which other mask
features are integrated including nasal tubes, hose connections,
clips, and/or ducting, for example. In the preferred embodiment,
nasal tubes are also designed based on anatomical points including
(a) the center points of the nostrils 820, (b) tip of the nose 810,
and (c) bridge of the nose 812. In particular, the nasal tubes are
concentric about the center points of the nostrils, and the
orientation of the nasal tubes is parallel to the line segment
joining the tip of the nose 810 and bridge of the nose 812.
[0097] In another embodiment, the mask is designed using the "press
fit" design technique illustrated in FIGS. 9A-9D. In this process,
the mask is designed by morphing or otherwise conforming a generic
mask onto the patient scan data. Using a generic 3D model of a
mask, the mask is first scaled, rotated, and vertically aligned at
a position in front of the face scan data using the anatomical
features and various points including the mid-nose point 830 and
dimple point 834. That is, the mask model is positioned adjacent to
the scan data by adjusting the upper and lower edges of the mask to
coincide, vertically, with the mid-nose point as well as the dimple
point. The mask model 910 is adjacent to the scan data 930 in the
perspective view of FIG. 9B and in cross section in FIG. 9C.
Second, the mask model 910, which is in front of the scan data 930,
is mathematically pressed onto or stretched on the face such that
the inner surface 920 of the mask takes on and/or conforms to the
shape of the scan data 930. The generic mask before pressing is
shown in FIG. 9C and the custom mask 912 after pressing is shown in
FIG. 9D. The stretching operation is complete when the inner
surface 920 of the mask is substantially similar to the patient's
face scan data. The final mask model may then be transmitted to the
printer for manufacturing.
[0098] Illustrated in FIGS. 10A-10N is a first embodiment of a
sleep apnea device including a face mask 1000 coinciding with the
patient's nose, a headband 1010 for securing the mask to the face,
and air ducts 1020 for channeling pressurized air from the CPAP
machine to the mask. The face mask may further include a pair of
nasal tubes that channel air directly to nose, as well as one or
more manifolds 1002 or connectors to couple the air ducts to the
nasal tubes. The air ducts 1020 in the preferred embodiment are
vinyl or polycarbonate tubes that run from the back of the head,
along one or both sides of the face, and to face mask. The
polycarbonate tubes may diverge from the back of the head where
they operably connect to a single coupling configured to detachably
attach to the output tube of the CPAP machine. The multi-tube
coupling 1030 may be referred to herein as a "spider coupling"
shown in more detail in FIGS. 17A-17D. In the preferred embodiment,
the air ducts are affixed to the outer face of the headband using
retainers 1040 such as tines, clips, or channels into which the
silicon tubes are seated or otherwise affixed. The headband 1010 is
generally made of flexible material like silicone where it contacts
the patient's skin. Left and rights sides of the headband may be
configured to clip or otherwise attach at the back of the patient's
head using a fastener including a clasp, clip, button, strap, or
magnet, for example.
[0099] In accordance with the present invention, the inner face
1060 of the face mask and inner face of the headband are designed
to conform to the patient's face, i.e, the mask and headband are
made compliant with the patient. In addition, the size and spacing
of the pair of nasal tubes is tailored specifically to the patient
for whom the mask is intended. Since the mask is designed based on
the patient's scan data, the mask and headband are custom tailored
for the patient. In general, no two masks can be the same.
[0100] The portion of the mask that coincides with the patient's
face preferably includes a rigid portion and flexible portion that
makes contact with the patient's face. The flexible portion in
contact with the patient's face may consist of a bio-safe
elastomeric such as silicone or rubber, for example. The rigid
portion of the mask may comprise or consist of a plastic capable of
being built up in a layer-wise fashion using one or more rapid
prototyping systems or computer-aided manufacturing systems
including, for example, those techniques discussed herein. In the
exploded views shown in FIGS. 10J and 10K, the facial portion of
the mask includes a base plate and left and right manifolds 1002
shown in FIGS. 10L through 10N. Each manifold is a substantially
enclosed cavity or compartment including (1) a plurality of input
holes 1004 configured to receive one end of each polycarbonate tube
1020, and (2) an output hole 1006 that channels air into one of the
nasal tubes. Each manifold in configured to snap into and friction
fit onto the base plate.
[0101] Like the mask, the inner face 1060 of the left and right
portions of the headband 1010 may consist of a flexible material
including silicone or other elastomeric material that is
comfortable against the patient's skin.
[0102] Referring to FIG. 10D, the mask includes nasal tubes 1050
that are configured to extend a short distance into the patient's
nose. The nasal tubes are shown in lateral cross section in FIG.
10F and in vertical cross section in FIG. 10G. In the preferred
embodiment, the nasal tubes are formed from an elastomeric
material. When positive air pressure is applied to the mask, the
nasal tubes may expand slightly within the nose to better conform
to the patient's nose and maintain the pressure induced by the CPAP
machine.
[0103] Referring to FIG. 10G, the mask in some embodiments includes
a plurality of magnets 1070 configured to apply a biasing force to
hold the mask in place. As shown, magnets may be embedded in a
location outside the nose as well as a location inside the nasal
tube to generate a gentle pinching force that helps to secure the
mask in place on the patient's face. In the preferred embodiment,
the cavities configured to receive the magnets and/or ferrous
material are included in the model of the mask and the
magnets/ferrous material inserted after production of the mask.
[0104] In a second embodiment illustrated in FIGS. 11A through 11F,
the sleep apnea mask uses the polycarbonate tubes 2020 to secure
the face mask 2000 to the patient's head without an underlying band
or strap. As discussed above, the face mask includes a base plate
2060 with a conformal inner surface, nasal tubes 1050, and
manifolds 2002 coupled to the polycarbonate tubes. The inner
surface of the base plate 2060 includes a recess configured to
conform to the patient's nose. Unlike the previous embodiment, the
tubes that make up the air duct attached to a plurality of
retainers 2040 with channels into which the tubes seat. The first
retainer 2044 in FIG. 11F receives a plurality of tubes from the
CPAP coupling 2030 and bifurcates them to the left and right sides
of the patient's face using guide holes 2046. A second and third
set of retainers 2040 hold the tubes side-by-side in channels 2042
as the tubes traverse the patient cheek to the face mask. The face
mask 2000 includes additional channels 2022 into which the tubes
seat, thus serving as a fourth set of retainers. The location of
the mask on the face depends on the length of the tubes between the
face mask and the first retainer. To adjust the placement of the
face mask, the patient need only retract the tubes from the first
retainer or further insert the tubes into the first retainer.
[0105] In a third embodiment illustrated in FIGS. 12A through 12B,
the sleep apnea mask 3000 is substantially similar to the mask 1000
of the first embodiment with the inclusion of an enclosure 3004
that covers a portion of the nose and mouth. In this embodiment,
the manifold (not shown) outputs air into both the nasal tubes 1050
as well as the inside of the enclosure 3004 covering the mouth,
thereby better maintaining pressure in the patient's respiratory
system. The enclosure, however, does include vent holes 3006 enable
air to readily escape if the patient should sneeze. Like the first
embodiment above, the third embodiment of the mask further includes
a headband for securing the mask to the face and external air ducts
for channeling pressurized air from the CPAP machine to the
mask.
[0106] Illustrated in FIGS. 13A through 13J is a fourth embodiment
of a sleep apnea device including a face mask 4000 coinciding with
the patient's nose, a headband 4010, and one or more air ducts 4020
for channeling pressurized air from the CPAP machine to the mask. A
coupling 4030 with tubes conducts air from the CPAP machine to the
air ducts of the headband. The coupling 4030 is shown in more
detail in FIGS. 17A-17D. The air ducts 4020, which are embedded
internally within the headband 4010, run from the back of the head,
along one or both sides of the face, and to nasal tubes 4050 in the
face mask. A cross section of the air ducts is shown in FIG. 13H,
and a cross section of the face mask and cavity shown in FIG. 13I.
The cavity is created in the space between an enclosure 4004 and
the base plate 4060. The enclosure includes a plurality of panels
4002 that snap in and frictionally fit to the enclosure. Similarly,
the left and right portions of the headband 4010 include caps or
panels 4012 that snap in and frictionally fit to the headband. The
caps or panels 4002 and 4012 provide access to the air ducts and
cavity for purposes of removing support material that was deposited
in the cavity during the manufacturing process.
[0107] The nasal tubes 4050 may include a cavity into which a
magnet 4052 is inserted. A corresponding cavity and magnet 4052 are
built into the enclosure in a position in proximity to the nasal
tubes 4050.
[0108] The headband 4010 is generally made of flexible material
where it contacts the patient's skin. Left and rights sides of the
headband may be configured to fasten at the back of the patient's
head using a fastener 4014, clip, strap, or magnet, for
example.
[0109] In accordance with the present invention, the inner face
4060 of the face mask and inner face of the headband are designed
to conform to the patient's face, i.e., the mask and headband are
made compliant with the patient. Since the sleep apnea device is
designed based on the patient's scan data, the mask and headband
are custom tailored for the patient. The inner face of the mask and
headband may consist of a flexible elastomeric material including
silicone, for example. The outer portion of the mask and headband
may consist of a plastic capable of being built up in a layer-wise
fashion using one or more computer-aided manufacturing systems
including, for example, those techniques discussed herein
above.
[0110] In the preferred embodiment, the mask includes elastomeric
webbing 4070 covering the front of the face mask and the perimeter
of the openings that receive panels in the sides of the headband.
The webbing provides additional structural integrity for the sleep
apnea device, similar to the manner in which tendons or other
structural members provide structural support in anatomical or
architectural environments. The elastomeric webbing may be
constructed in a layer-wise manner along with the rest of the mask.
The webbing may be formed from any of a number of thermoset
materials including hard and soft thermosets known to those skilled
in the art.
[0111] In a fifth embodiment illustrated in FIG. 14A through 14H,
the sleep apnea mask 5000 is substantially similar to the fourth
embodiment with the inclusion of an enclosure that covers both the
nose and mouth. In this embodiment, the internal chamber 5052
connects the air ducts 5020 with both nasal tubes 5050 as well as
an opening to the mouth, thereby better distributing the pressure
from the CPAP machine to the patient's respiratory system. Like the
fourth embodiment, the mask and headband 5010 includes panels 5002,
5012 that detachably attach by means of a friction fit in order to
remove support material that accumulates during the manufacturing
process. The fastener 5014 at the back of the headband as well as
the CPAP coupling 5030 are similar to those shown in the fourth
embodiment discussed above. The inner face 5060 of the mask and
headband are configured to conform to the face of the patients as
determined by the patient's face scan data.
[0112] The face mask configured to cover the nose and mouth may
further include a sneeze inhibition mechanism to prevent injury or
discomfort should the patient sneeze while wearing the mask. In the
preferred embodiment, the mechanism consists of a plurality of
holes or vias 5006 configured to expel air from the front of the
face mask. In other embodiments, the sneeze inhibition mechanism
includes a pressure-sensitive valve that releases air from the mask
when the pressure in the mask exceeds a predetermine threshold. The
mask may further include elastomeric webbing 5070 covering the
front of the face mask.
[0113] Illustrated in FIGS. 15A through 15E is a sixth embodiment
of a sleep apnea device 6000 including a face mask and one or more
air ducts 6020 for channeling pressurized air from the CPAP machine
to the mask. The mask includes a left portion and a right portion
6002, each configured to attach to one side of the patient's nose.
Both portions of the mask include nasal tubes 6050 with pairs of
magnets configured to pull the nasal tube toward the outer portion
of the mask. The mask further includes at least one air duct 6020
connected to a CPAP machine for distributing air to the left and
right sides of the mask. Although the left and right portions are
shown as separate components, these portions may be rigidly
connected by means of one or more bridges (not shown) configured to
traverse the patient's nose.
[0114] In accordance with the present invention, the inner face of
the face mask is made compliant with the patient using the patient
scan data, thereby yielding a mask custom tailored for the patient.
The inner face of the mask may consist of a flexible material
including silicone, for example. The outer portion of the mask may
consist of a plastic capable of being built up in a layer-wise
fashion using one or more computer-aided manufacturing systems
including, for example, those techniques discussed herein.
[0115] In each of the six of the preferred embodiments above, the
sleep apnea device connects to a CPAP machine using an elastic
coupling. One version of an elastomeric CPAP coupling is shown in
FIGS. 17A-17D. In the preferred embodiment, the coupling is a
constructed from three elastomeric materials. The first elastomeric
material, e.g., silicone, is configured to easily flex under
pressure. The entire body of the coupling from the air ducts to the
CPAP output tube is constructed from the first elastic material.
The second elastomeric material is a structural material that
prevents the first elastomeric material from ripping or tearing.
The second elastomeric material is used to construct a webbing,
shell, pattern that enables the coupling to flex while still
holding pressure. The third elastomeric coupling forms a semi-rigid
structure for contacting the inner surface of the CPAP output
tube.
[0116] Illustrated in FIGS. 16A through 16G is a seventh embodiment
of a sleep apnea device including a face mask 7000 with nasal tubes
7050 and one or more valves 7090 that regulate the flow of air out
of the nasal tubes. The mask comprises left and right portions 7002
rigidly affixed to one another by means of a bridge 7080. In this
embodiment, there is no CPAP or CPAP coupling. Instead, the values
7090 are configured to passively inhibit the flow of air in order
to maintain positive pressure in the patient's lungs without any
external CPAP input. In the preferred embodiment, the values
comprise one-way values that readily admit air during inhalation
while inhibiting the flow of air out of the nose when the patient
exhales. In this manner, the sleep apnea device helps to maintain a
higher volume of air in the patient's lungs than would be present
without the sleep apnea device. The additional volume, in turn,
helps to keep the patient's airways open and reduce the detrimental
effects of sleep apnea.
[0117] In accordance with the present invention, the inside face
7060 of the mask is designed using the patient scan data so that it
conforms to the patient's face, i.e, made compliant with the
patient. The left and right mask portions may also be constructed
from two or more materials including a silicone or other material
that contacts the patient's face and a second more rigid material
forming the body of the mask and nasal tubes.
[0118] The one-way valve 7090 in this embodiment includes a
retainer 7096 and an insert 7092 residing in a cavity in a nasal
tube. The insert 7092 is captured between the retainer 7096 and the
inner wall of the nasal tube. The insert 7092 is permitted to move
vertically a small distance within the confines of the cavity. The
insert 7092 includes a plurality of apertures including a primary
aperture 7093 and plurality of secondary apertures 7094. The
primary aperture 7093 permits air to flow in and out of the valve
with equal resistance in both directions. The secondary apertures
7094, in contrast, provide more resistance to the flow of air out
of the nostril than the flow of air in the nostril. To accomplish
this, the apertures are oriented at an angle such that the top of
the aperture resides relatively close to the primary aperture while
the bottom of the aperture resides relatively far from the primary
aperture. When the patient inhales, the insert is forced by air
pressure to the top of the cavity which allows air through both the
primary and secondary apertures. When the patient exhales, the
insert is forced by air pressure to the bottom of the cavity where
the secondary apertures make contact with and get blocked by the
retainer, thereby preventing the flow of air through the secondary
apertures. Although air is still expelled through the primary
aperture, the size and shape of the primary aperture is configured
to provide resistance to maintain sufficient pressure in the
patient's lungs between breaths.
[0119] Referring to the cross section in FIG. 16G, one or more
sleep apnea masks discussed above include a plurality of magnets
4052 configured to apply a biasing force to hold the mask in place.
For example, magnets may be embedded in cavities in the nasal tubes
4050 and cavities in the mask in proximity to one another. The
magnets are oriented so as to flex the nasal tubes toward the face
mask which provides a gentle pinching force about the nose. The
pinching force helps to secure the mask on the patient's face in
addition to or instead of a headband. In addition to magnets, the
gap between the nasal tubes and/or face mask may be adjusted to
enhance the friction fit of the mask the patient's face.
[0120] In each of the seven embodiments above, the sleep apnea
device directly contacts the patient's face. To enhance the seal,
one or more embodiments may employ a pattern embossed on the inner
side of the mask and/or headband where it contacts the user. The
pattern may be designed to enhance the pressure seal between the
mask and face or increase the friction fit of the mask to the face.
The pattern may include parallel lines, hashing, or array of dots,
for example.
[0121] Illustrated in FIGS. 17A-17B are perspective views of a
pliable CPAP coupling used in some embodiments of the sleep apnea
mask. The coupling 8000 includes a housing 8010 and an input port
8014 configured to connect to a CPAP machine output tube. The
coupling is designed to detachably attach to the CPAP machine using
a friction fit. When inserted into the recess 8012 of the coupling,
the output of the CPAP machine is squeezed by the outer wall 8010
and inner wall of the input port 8014 to hold the CPAP output in
place while the user sleeps. The coupling also includes a plurality
of output ports 8020 configured to receive tubes, preferably
polycarbonate tubing, that connects the coupling to the input of
the air duct on the sleep apnea mask. The inner diameter and wall
thickness of the output ports are configured to securely hold the
polycarbonate tubing to avoid inadvertent detachment during use of
the mask.
[0122] Illustrated in FIG. 17D is an exploded view of the CPAP
coupling showing the various components including external webbing
8030A, 8030B used to maintain the structural integrity of the
coupling. The webbing may be constructed from a relatively high
tensile strength thermoset material. In the preferred embodiment,
the entire CPAP coupling is constructed from highly elastic
materials, primarily silicones. This provides for a pleasant user
experience when touched by the patient, leaned on by the patient,
or rolled against by the patient.
[0123] Some of the sleep apnea devices and/or face mask above are
produced directly using one or more layer-wise construction methods
described above. In other embodiments, the sleep apnea devise and
masks are produced using an investment molding technique
illustrated in FIG. 18. In this embodiment, one or more ".STL"
files are generated 1810, the set of ".STL" files defining the size
and shape of molds and bucks from which mask components are cast.
The molds are then 3D printed 1820 from any of a number of
materials while the bucks are 3D printed 1830 from a second
material that is capable of being dissolved by a first solvent. The
mold and bucks are assembled 1840 and the mask component cast 1850.
The casting material from which the component is made, preferably a
thermoset material, is resistant to the first solvent. Thereafter,
solvent is used to dissolve 1860 the bucks and release 1870 the
mask. In some embodiments, the mold is made of a soluble material
that is the same or different that the material from which the
bucks are made. In addition, the component may subsequently be
washed to remove all traces of solvent before the mask is used by
the patient.
[0124] Illustrated in FIG. 19 is a flowchart of a second embodiment
of an investment molding technique. After the mask model has been
determined using the DPDS 130 described above, the fabrication
controller 136 generates 1910 ".STL" files defining the shape of
one or mask components, negative spaces corresponding to air ducts,
a mold if applicable, support structures if applicable, and one or
more bucks if applicable. The mask components generally include a
plurality of separate components corresponding to individual
pieces, layers, or structures in the final mask. Thereafter, the
".STL" files for the mask components and negative spaces are
concurrently 3D printed 1920 using one or more soluble materials.
The negative spaces are generated as a solid structure using a
soluble material that is later removed. The ".STL" files for the
molds, supports, and bucks are printed 1930 either concurrently
with the mask components or printed separately and assembled later.
Once the components, negative mold, supports, and bucks are
assembled, a first solvent is applied 1940 in order to remove one
of the multiple mask components. When the solvent is removed, a new
void is created. A thermoset material is then injected 1950 into
this new void and the thermoset material allowed to cure in place.
If there are additional soluble materials representing mask
components remaining, decision block 1960 is answered in the
negative. The next soluble material is dissolved and next thermoset
material injected. The process is repeated until all mask
components are produced. Thereafter, the material corresponding to
the negative space is dissolved 1970 using an additional solvent.
As one skilled in the art will appreciate, thermoset structures
must be resistant to any solvents that are applied subsequent to
curing in order to prevent those thermoset materials from being
removed unintentionally. If a mold or support structure was used,
those materials may be separated 1980 from the remaining mask
components. At this point, the resulting sleep apnea mask may be
constructed from multiple materials that are completely bonded
together, and the mask may contain one or more internal negative
spaces.
[0125] In the preferred embodiment, combinations of soluble
material/solvent include: [0126] (1) PVA (Polyvinyl Alcohol)/water;
[0127] (2) HIPS (High Impact Polystyrene)/Lemonine or Terpene
(citric acid); [0128] (3) PLA (polylactic acid).parallel.Sodium
Hydroxide (caustic soda) [0129] (4) ABS (acrylonitrile butadiene
styrene)/Acetone; [0130] (5) Nylon/Acetic Acid; [0131] (6)
Polycarbonate/Dichloromethane; and [0132] (7) Glucose or glucose
gelatin/enzymes.
[0133] Illustrated in FIGS. 20A through 20L is a diagrammatic
illustration of the 3D printing investment casting technique of the
preferred embodiment. In brief, the final object is constructed by
generating a set of temporary structures called "patterns" that are
then sequentially removed and replaced using solvents and thermoset
materials. FIG. 20A shows the final object after completion of the
printing and casting. FIG. 20B shows a partial exploded view of the
casting where the three materials that make up the casting are
separated out to show the dimensionality of the component
parts.
[0134] In accordance with the preferred embodiment, a multi-nozzle
FDM machine, for example, is employed to generate three separate
patterns by depositing three separate materials referred to here as
"pattern A," "pattern B," and "pattern C" shown in FIGS. 20C-20E.
Each of the three patterns represents a component of the final
object. As shown, multiple nozzles are used to deposit the three
separate pattern materials and generate the object in a layer-wise
manner. The temporary object made of pattern materials is shown in
FIG. 20F. The completed object resides in a mold, referred to
herein as "mold D."
[0135] Referring to FIG. 20G, after the patterns are fully printed,
a first solvent referred to as "solvent A" is used to dissolve
pattern A. Referring to FIG. 20H, once the solvent is removed and
the part cleaned, a nozzle injects "material A" into the negative
space previously occupied by pattern A. As one skilled in the art
will appreciate, pattern B and pattern C must be resistant to the
solvent A.
[0136] Referring to FIG. 20I, a second solvent referred to as
"solvent B" is then used to dissolve pattern B after material A has
cured. Referring to FIG. 20J, once solvent B is removed and the
part cleaned, a nozzle injects "material B" into the negative space
previously occupied by pattern B. Material A and pattern C must be
resistant to the solvent B.
[0137] Referring to FIG. 20K, a third solvent referred to as
"solvent C" is then used to dissolve pattern C after material B has
cured. Referring to FIG. 20L, once solvent C is removed and the
part cleaned, a nozzle injects "material C" into the negative space
previously occupied by pattern C. Material A and material B must be
resistant to the solvent C. After material C has cured, the
completed object may be released from the mold.
[0138] In the preferred embodiment, materials A, B, and C are
thermoset materials, preferably a combination of hard and soft
silicone thermoset materials. However, one skilled in the art will
appreciate that a wide range of alternative materials may be
employed and 3D printing techniques employed to produce the
investment casting technique of the present invention.
[0139] Illustrated in FIGS. 21A through 21M is a sequence of
diagrammatic illustration showing the 3D printing investment
casting technique used to make a CPAP coupling. The final coupling
shown in FIG. 21B is shown in cross section in FIG. 21A. In this
embodiment, the coupling is constructed from three silicone
thermoset materials corresponding to three pattern
materials--pattern A, pattern B, and pattern C. The three pattern
materials are concurrently deposited in a layer-wise fashion using
a FDM printing process shown in FIGS. 21C through 21E. A fourth
material may be concurrently deposited to produce a mold around the
patterns, referred to as mold D. The object constructed from
pattern material is shown in perspective in FIG. 21F and cross
section in FIG. 21G.
[0140] Referring to FIG. 21H, after the patterns are fully printed,
a "solvent A" is used to dissolve pattern A. Referring to FIG. 21I,
once the solvent is removed and the part cleaned, a nozzle pours or
injects "material A" into the negative space previously occupied by
pattern A. As one skilled in the art will appreciate, pattern B and
pattern C are resistant to the solvent A. As shown, one or more
sprues and gates may be used to inject the material and evacuate
air, as needed.
[0141] Referring to FIG. 21J, "solvent B" is then used to dissolve
pattern B after material A has cured. Referring to FIG. 21K, once
solvent B is removed and the part cleaned, a nozzle injects
"material B" into the negative space previously occupied by pattern
B. Material A and pattern C are resistant to the solvent B.
[0142] Referring to FIG. 21L, "solvent C" is then used to dissolve
pattern C after material B has cured. Referring to FIG. 21M, once
solvent C is removed and the part cleaned, a nozzle injects
"material C" into the negative space previously occupied by pattern
C. Material A and material B must be resistant to the solvent C.
After material C has cured, the completed object may be released
from the mold and the remnants of the sprues and gates removed. The
complete coupling may then be employed with a face mask produced
using the same technique described above, for example.
[0143] Illustrated in FIGS. 22A through 22G is a diagrammatic
illustration of the investment casting technique used to make a
running shoe. The completed running shoe is shown in perspective
FIG. 22A and in exploded view in FIG. 22B. FIG. 22C-FIG. 22G show
each of five different materials being injected into the mold
during assembly. Material A is injected to form the tread of the
shoe in FIG. 22C, material B injected to form the sole of the shoe
in FIG. 22D, material C injected to form the shoe "upper" in FIG.
22E, material D injected to form the insole of the shoe FIG. 11F,
and material E injected to form the eyelets in FIG. 22G. Although
not shown, each injection step is preceded by a step of dissolving
a pattern, as shown in the figures above. After the final injection
step, the completed shoe is removed from the mold and the sprues
and gates remove. As one skilled in the art will appreciate, the
investment casting technique described above can be employed to
make shoes having a structure and composition that prior art
techniques cannot produce do to limitations in materials and
casting techniques.
[0144] The five materials correspond to the shoe tread, sole,
padding, upper, and lace grommets. In the preferred embodiment, the
first four materials injected are thermoset materials while the
last material is nylon or other hard plastic.
[0145] Systems and user interfaces of the present invention may be
implemented with one or more non-transitory computer readable
media, wherein each medium may be configured to include thereon
data or computer executable instructions for manipulating data. The
computer executable instructions include data structures, objects,
programs, routines, or other program modules that may be accessed
by a processing system, such as one associated with a
general-purpose computer or processor capable of performing various
different functions or one associated with a special-purpose
computer capable of performing a limited number of functions.
Computer executable instructions cause the processing system to
perform a particular function or group of functions and are
examples of program code means for implementing steps for methods
disclosed herein. Furthermore, a particular sequence of the
executable instructions provides an example of corresponding acts
that may be used to implement such steps. Examples of computer
readable media include random-access memory ("RAM"), read-only
memory ("ROM"), programmable read-only memory ("PROM"), erasable
programmable read-only memory ("EPROM"), electrically erasable
programmable read-only memory ("EEPROM"), compact disk read-only
memory ("CD-ROM"), or any other device or component that is capable
of providing data or executable instructions that may be accessed
by a processing system. Examples of mass storage devices
incorporating computer readable media include hard disk drives,
magnetic disk drives, tape drives, optical disk drives, and solid
state memory chips, for example. The term processor as used herein
refers to a number of processing devices including personal
computing devices, servers, general purpose computers, special
purpose computers, application-specific integrated circuit (ASIC),
and digital/analog circuits with discrete components, for
example.
[0146] As one skilled in the art will appreciate, the various
dimensions of a mask generally vary from person to person because
those features are dictated by the size and locations of the
features on each patient's face.
[0147] Therefore, the invention has been disclosed by way of
example and not limitation, and reference should be made to the
following claims to determine the scope of the present
invention.
* * * * *