U.S. patent application number 15/702554 was filed with the patent office on 2018-10-04 for methods of producing removable oral devices.
The applicant listed for this patent is SCIENTIFIC INTAKE LIMITED CO.. Invention is credited to Marc M. Gibeley, William H. Longley, Richard P. Schneider, Anthony R. Tremaglio.
Application Number | 20180280125 15/702554 |
Document ID | / |
Family ID | 63671913 |
Filed Date | 2018-10-04 |
United States Patent
Application |
20180280125 |
Kind Code |
A1 |
Longley; William H. ; et
al. |
October 4, 2018 |
METHODS OF PRODUCING REMOVABLE ORAL DEVICES
Abstract
Certain configurations of methods which can be used to produce
removable oral devices are described. In some instances, the
removable oral devices can be produced using molding, digital
scanning, on demand printing and/or other processes. In certain
examples, the produced removable oral device can be used in weight
management, athletic performance or in other applications.
Inventors: |
Longley; William H.;
(Atlanta, GA) ; Schneider; Richard P.; (Bedford,
NY) ; Tremaglio; Anthony R.; (Waban, MA) ;
Gibeley; Marc M.; (Boxford, MA) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
SCIENTIFIC INTAKE LIMITED CO. |
Lawrence |
MA |
US |
|
|
Family ID: |
63671913 |
Appl. No.: |
15/702554 |
Filed: |
September 12, 2017 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
62477764 |
Mar 28, 2017 |
|
|
|
62521498 |
Jun 18, 2017 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61C 7/002 20130101;
A61C 13/0004 20130101; A61C 7/10 20130101; A61C 13/0006 20130101;
A61C 9/0046 20130101; A61C 13/0013 20130101; A61C 13/0022
20130101 |
International
Class: |
A61C 13/00 20060101
A61C013/00; A61C 7/00 20060101 A61C007/00 |
Claims
1. A method of producing a removable oral device comprising
three-dimensionally printing a removable oral device using a first
material, the printed removable oral device comprising a palatal
element coupled to an optional clasping element, in which the
palatal element is configured to contact a roof of a user's mouth
at a palatal surface, the palatal element comprising a body
comprising a thickness configured to lower a vaulted area of the
roof of the mouth to decrease an overall oral volume of the mouth
to a first oral volume, and wherein the optional clasping element
is configured to assist in removal of the removable oral device
from the mouth.
2. The method of claim 1, further comprising printing areas of the
body adjacent to the clasping element using a second material
softer than the first material.
3. The method of claim 1, further comprising three-dimensionally
printing the palatal element using a photo-curable material.
4. The method of claim 3, further comprising disposing one or more
wires on a printer support as the clasping element and printing the
photo-curable material into the printer support comprising the one
or more wires to provide the removable oral device.
5. The method of claim 4, further comprising photo-curing the
printed palatal element using UV/Visible light.
6. The method of claim 1, further comprising printing each of the
palatal element and the clasping element using a photo-curable
material.
7. The method of claim 1, further comprising three-dimensionally
printing the removable oral device using an inkjet
three-dimensional printer.
8. The method of claim 1, further comprising three-dimensionally
printing the removable oral device using digital light
processing.
9. The method of claim 1, further comprising three-dimensionally
printing the removable oral device from a digital image of the
user's mouth.
10. The method of claim 10, further comprising three-dimensionally
printing the palatal element of the digital image using a
photo-curable material.
11. The method of claim 11, further comprising disposing one or
more wires on a printer support as the clasping element and
printing the photo-curable material onto the printer support
comprising the one or more wires to provide the removable oral
device.
12. The method of claim 1, further comprising configuring the
removable oral device to not alter a position of the user's
teeth.
13. The method of claim 1, further comprising configuring the
removable oral device to not retain a position of the user's
teeth.
14. A method comprising: imaging an oral cavity of a human; and
providing a removable oral device from the imaged oral cavity, the
provided removable oral device comprising a palatal element coupled
to an optional clasping element, in which the palatal element is
configured to contact a roof of a user's mouth at a palatal
surface, the palatal element comprising a body comprising a
thickness configured to lower a vaulted area of the roof of the
mouth to decrease an overall oral volume of the mouth to a first
oral volume, and wherein the optional clasping element is
configured to assist in removal of the removable oral device from
the mouth.
15. The method of claim 14, further comprising producing the
removable oral device with areas of the body adjacent to the
clasping element being softer than other areas of the body.
16. The method of claim 14, further comprising imaging the oral
cavity using an image head electrically coupled to a wireless
device.
17. The method of claim 14, further comprising imaging the oral
cavity using a probe configured to capture ultrasound images of the
oral cavity.
18. The method of claim 14, further comprising imaging the oral
cavity using a probe configured to capture still images of the oral
cavity.
19. The method of claim 14, further comprising imaging the oral
cavity using a probe configured to capture video images of the oral
cavity.
20. The method of any of claims 14, further comprising wirelessly
transmitting images from the probe to a mobile device.
21. The method of claim 14, further comprising using the image of
the oral cavity to print a removable oral device.
22. The method of claim 21, further comprising printing the
removable oral device using three-dimensional printing.
23. The method of claim 14, further comprising configuring the
removable oral device to not alter a position of the user's
teeth.
24. The method of claim 14, further comprising configuring the
removable oral device to not retain a position of the user's
teeth.
25. A method comprising: obtaining an impression of an oral, cavity
of a human using an impression tray and impression material; and
providing a removable oral device using the impression of the oral
cavity, the removable oral device comprising a palatal element
coupled to an optional clasping element, in which the palatal
element is configured to contact a roof of a user's mouth at a
palatal surface, the palatal element comprising a body comprising a
thickness configured to lower a vaulted area of the roof of the
mouth to decrease an overall oral volume of the mouth to a first
oral volume, wherein the body comprises a variable hardness across
a tongue surface of the body, and wherein the optional clasping
element is configured to assist in removal of the removable oral
device from the mouth.
26. The method of claim 25, further comprising printing the
impression tray using a three-dimensional printer.
27. The method of claim 25, further comprising using an image of
the oral cavity in combination with the impression of the oral
cavity to provide a composite image.
28. The method of claim 25, further comprising printing the palatal
element from the composite image using a three-dimensional
printer.
29. The method of claim 25, further comprising configuring edges of
the palatal element to be softer than an apex of the palatal
element.
30. The method of claim 25, further comprising configuring the
removable oral device to not alter a position of the user's teeth.
Description
PRIORITY APPLICATIONS
[0001] This application claims priority to and the benefit of U.S.
62/477,764 filed on Mar. 28, 2017 and entitled "METHODS OF
PRODUCING REMOVABLE ORAL DEVICES" and claims priority to U.S.
Provisional Application No. 62/521,498 filed on Jun. 18, 2017 and
entitled "METHODS OF USING REMOVABLE ORAL DEVICES." The entire
disclosure of each of these applications is hereby incorporated
herein by reference for all purposes.
CROSS-REFERENCE TO RELATED APPLICATIONS
[0002] This application is related to, and incorporates by
reference herein, each of the following patent applications: U.S.
Provisional Application No. 62/477,752 filed on Mar. 28, 2017 and
entitled "REMOVABLE ORAL DEVICES," U.S. Provisional Application No.
62/477,760 filed on Mar. 28, 2017 and entitled "METHODS OF USING
REMOVABLE ORAL DEVICES," U.S. Provisional Application No.
62/477,766 filed on Mar. 28, 2017 and entitled "SYSTEMS INCLUDING
REMOVABLE ORAL DEVICES," and U.S. Provisional Application No.
62/477,768 filed on Mar. 28, 2017 and entitled "REMOVABLE ORAL
DEVICES AND THEIR USE IN COMBINATION WITH PHARMACOLOGICAL AGENTS,
IMPLANTS AND OTHER DEVICES."
TECHNOLOGICAL FIELD
[0003] This application is directed to methods of producing
removable oral devices. More particularly, certain configurations
described herein are directed to methods of producing removable
oral devices using molding, digital scanning, on demand printing
and/or other suitable techniques.
BACKGROUND
[0004] Many methods for controlling weight exist. Most existing
methods do not provide long term weight loss or health
benefits.
SUMMARY
[0005] Certain illustrative configurations are directed to various
methods which can be used to produce removable oral devices that
can be inserted into the mouth. As noted in more detail below, the
methods can permit production of a customized removable oral device
of various configurations that can be used for various end
uses.
[0006] In one aspect, a method of producing a removable oral device
comprises printing, e.g., three-dimensionally printing, a removable
oral device using a first material. In some examples, the printed
removable oral device comprises a palatal element coupled to an
optional clasping element. In certain instances, the palatal
element can be configured to contact a roof of a user's mouth at a
palatal surface and comprises a body comprising a thickness
configured to lower a vaulted area of the roof of the mouth to
decrease an overall oral volume of the mouth to a first oral
volume. The clasping element, when present, can be configured to
assist in removal of the removable oral device from the mouth
and/or to retain the palatal surface of the palatal element against
the roof of the user's mouth when the removable oral device is
inserted into the user's mouth.
[0007] In certain configurations, the method comprises printing
areas of the body adjacent to the clasping element using a second
material softer than the first material.
[0008] In other configurations, the method comprises
three-dimensionally printing the palatal element using a
photo-curable material.
[0009] In some examples, the method comprises disposing one or more
wires on a printer support as the clasping element and printing the
photo-curable material into the printer support comprising the one
or more wires to provide the removable oral device.
[0010] In some embodiments, the method comprises photo-curing the
printed palatal element using UV/Visible light.
[0011] In some configurations, the method comprises printing each
of the palatal element and the clasping element using a
photo-curable material.
[0012] In other examples, the method comprises three-dimensionally
printing the removable oral device using an inkjet
three-dimensional printer.
[0013] In some examples, the method comprises three-dimensionally
printing the removable oral device using digital light
processing.
[0014] In further examples, the method comprises
three-dimensionally printing the removable oral device from a
digital image of the user's mouth.
[0015] In other examples, the method comprises three-dimensionally
printing the palatal element of the digital image using a
photo-curable material.
[0016] In some examples, the method comprises disposing one or more
wires on a printer support as the clasping element and printing the
photo-curable material onto the printer support comprising the one
or more disposed wires to provide the removable oral device.
[0017] In certain configurations, the method comprises configuring
the removable oral device to not alter a position of the user's
teeth.
[0018] In other configurations, the method comprises configuring
the removable oral device to not retain a position of the user's
teeth.
[0019] In another aspect, a method comprising imaging an oral
cavity of a human, and providing a removable oral device from the
imaged oral cavity is described. For example, the provided
removable oral device comprises a palatal element coupled to an
optional clasping element. In some instances, the palatal element
is configured to contact a roof of a user's mouth at a palatal
surface. In some examples, the palatal element comprises a body
comprising a thickness configured to lower a vaulted area of the
roof of the mouth to decrease an overall oral volume of the mouth
to a first oral volume. If desired, the palatal element may
comprise a variable hardness. In some examples where a clasping
element is present, the clasping element is configured to assist in
removal of the removable oral device from the mouth.
[0020] In certain examples, the method comprises producing the
removable oral device with areas of the body adjacent to the
clasping element being softer than other areas of the body.
[0021] In some examples, the method comprises imaging the oral
cavity using an image head electrically coupled to a wireless
device.
[0022] In other examples, the method comprises imaging the oral
cavity using a probe configured to capture ultrasound images of the
oral cavity.
[0023] In some embodiments, the method comprises imaging the oral
cavity using a probe configured to capture still images of the oral
cavity.
[0024] In other embodiments, the method comprises imaging the oral
cavity using a probe configured to capture video images of the oral
cavity.
[0025] In further embodiments, the method comprises wirelessly
transmitting images from the probe to a mobile device.
[0026] In certain examples, the method comprises using the image of
the oral cavity to print a removable oral device.
[0027] In some embodiments, the method comprises printing the
removable oral device using three-dimensional printing.
[0028] In other embodiments, the method comprises configuring the
removable oral device to not alter a position of the user's
teeth.
[0029] In some examples, the method comprises configuring the
removable oral device to not retain a position of the user's
teeth.
[0030] In an additional aspect, a method comprises obtaining an
impression of an oral cavity of a human using an impression tray
and impression material, and providing a removable oral device
using the impression of the oral cavity. For example, the removable
oral device may comprise a palatal element coupled to an optional
clasping element. In some examples, the palatal element is
configured to contact a roof of a user's mouth at a palatal surface
and may comprise a body comprising a thickness configured to lower
a vaulted area of the roof of the mouth to decrease an overall oral
volume of the mouth to a first oral volume. In some instances, the
body comprises a variable hardness across a tongue surface of the
body, e.g., can be softer at the edges than at an apex area. In
examples where a clasping element is present, the clasping element
can be configured to assist in removal of the removable oral device
from the mouth.
[0031] In certain examples, the method comprises printing the
impression tray using a three-dimensional printer.
[0032] In other examples, the method comprises using an image of
the oral cavity in combination with the impression of the oral
cavity to provide a composite image.
[0033] In some embodiments, the method comprises printing the
palatal element from the composite image using a three-dimensional
printer.
[0034] In certain examples, the method comprises configuring edges
of the palatal element to be softer than an apex of the palatal
element.
[0035] In other examples, the method comprises configuring the
removable oral device to not alter a position of the user's
teeth.
[0036] In another aspect, a method comprises imaging an oral cavity
of a human, and providing a removable oral device from the imaged
oral cavity. For example, the provided removable oral device
comprises a palatal element coupled to a clasping element. The
palatal element can be configured to contact a roof of a user's
mouth at a palatal surface and comprises a body comprising a
thickness configured to lower a vaulted area of the roof of the
mouth to decrease an overall oral volume of the mouth to a first
oral volume. The clasping element, when present, can be configured
to assist in removal of the removable oral device from the mouth
and/or to retain the palatal surface of the palatal element against
the roof of the user's mouth when the removable oral device is
inserted into the user's mouth.
[0037] In an additional aspect, a method comprises imaging an oral
cavity of a human using an image head configured to receive a
disposable cover, and printing a removable oral device from the
imaged oral cavity using a first material. In some examples, the
printed removable oral device comprises a palatal element coupled
to a clasping element. The palatal element can be configured to
contact a roof of a user's mouth at a palatal surface and comprises
a body comprising a thickness configured to lower a vaulted area of
the roof of the mouth to decrease an overall oral volume of the
mouth to a first oral volume. The clasping element, when present,
can be configured to assist in removal of the removable oral device
from the mouth and/or to retain the palatal surface of the palatal
element against the roof of the user's mouth when the removable
oral device is inserted into the user's mouth.
[0038] In another aspect, the imaging of the oral cavity may be
performed using an external imager which can be placed adjacent to
or near the teeth. The images from the external imager can be used
to print or otherwise provide a removable oral device as described
herein.
[0039] In another aspect, a method comprises imaging an oral cavity
of a human, printing a mold from the imaged oral cavity, and using
the printed mold to provide a removable oral device. In some
examples, the removable oral device comprises a palatal element
coupled to a clasping element. For example, the palatal element can
be configured to contact a roof of a user's mouth at a palatal
surface and comprises a body comprising a thickness configured to
lower a vaulted area of the roof of the mouth to decrease an
overall oral volume of the mouth to a first oral volume. The
clasping element, when present, is configured to assist in removal
of the removable oral device from the mouth and/or to retain the
palatal surface of the palatal element against the roof of the
user's mouth when the removable oral device is inserted into the
user's mouth.
[0040] In an additional aspect, a method comprises imaging an oral
cavity of a human, printing an impression tray using the imaged
oral cavity, using the printed impression tray and impression
material to obtain an impression of the oral cavity of the human,
and providing a removable oral device using the impression of the
oral cavity. In some embodiments, the removable oral device
comprises a palatal element coupled to a clasping element. For
example, the palatal element can be configured to contact a roof of
a user's mouth at a palatal surface and comprises a body comprising
a thickness configured to lower a vaulted area of the roof of the
mouth to decrease an overall oral volume of the mouth to a first
oral volume. The clasping element, when present, is configured to
assist in removal of the removable oral device from the mouth
and/or to retain the palatal surface of the palatal element against
the roof of the user's mouth when the removable oral device is
inserted into the user's mouth.
[0041] In another aspect, a method comprises obtaining an
impression of an oral cavity of a human using an impression tray
and impression material, and providing a removable oral device
using the impression of the oral cavity. In some instances, the
removable oral device comprises a palatal element coupled to a
clasping element. In some embodiments, the palatal element is
configured to contact a roof of a user's mouth at a palatal
surface. In certain examples, the palatal element comprises a body
comprising a thickness configured to lower a vaulted area of the
roof of the mouth to decrease an overall oral volume of the mouth
to a first oral volume, wherein the body comprises a variable
hardness across a tongue surface of the body. The clasping element,
when present, can be configured to assist in removal of the
removable oral device from the mouth and/or to retain the palatal
surface of the palatal element against the roof of the user's mouth
when the removable oral device is inserted into the user's
mouth.
[0042] In an additional aspect, a method comprises imaging an oral
cavity of a human using a first removable oral device comprising a
palatal element coupled to a clasping element, in which the palatal
element of the first removable oral device comprises a body
comprising an embedded camera configured to capture an image of the
oral cavity. The clasping element of the first removable oral
device, when present, can be configured to assist in removal of the
first removable oral device from the mouth when the first removable
oral device is inserted into the human's mouth. The method may also
comprise using the captured image to provide a second removable
oral device comprising a palatal element coupled to a clasping
element. The palatal element of the second removable oral device
can be configured to contact a roof of a user's mouth at a palatal
surface. The palatal element of the second removable oral device
comprises a body comprising a thickness configured to lower a
vaulted area of the roof of the mouth to decrease an overall oral
volume of the mouth to a first oral volume. The clasping element of
the second removable oral device, when present, can be configured
to assist in removal of the second removable oral device from the
mouth and/or to retain the palatal surface of the palatal element
of the second removable oral device against the roof of the user's
mouth when the second removable oral device is inserted into the
user's mouth.
[0043] In another aspect, a method comprises imaging an oral cavity
of a human using a first removable oral device comprising a palatal
element coupled to a clasping element, in which the palatal element
of the first removable oral device comprises a body comprising an
embedded sensor configured to map the oral cavity, and wherein the
clasping element of the first removable oral device is configured
to assist in removal of the first removable oral device from the
mouth when the first removable oral device is inserted into the
human's mouth. In some examples, the method also comprises using
the captured image to provide a second removable oral device
comprising a palatal element coupled to a clasping element. The
palatal element of the second removable oral device can be
configured to contact a roof of a user's mouth at a palatal
surface. The palatal element of the second removable oral device
comprises a body comprising a thickness configured to lower a
vaulted area of the roof of the mouth to decrease an overall oral
volume of the mouth to a first oral volume. The clasping element of
the second removable oral device, when present, is configured to
assist in removal of the second removable oral device from the
mouth and/or to retain the palatal surface of the palatal element
against the roof of the user's mouth when the second removable oral
device is inserted into the user's mouth.
[0044] In an additional aspect, a method of producing a removable
oral device comprises providing a removable oral device comprising
a palatal element coupled to a clasping element, in which the
palatal element is configured to contact a roof of a user's mouth
at a palatal surface. The palatal element comprises a body
comprising a thickness configured to lower a vaulted area of the
roof of the mouth to decrease an overall oral volume of the mouth
to a first oral volume. The palatal element comprises a softer
material at edges of the body than at an apex of the body. The
clasping element, when present, can be configured to assist in
removal of the removable oral device from the mouth and/or to
retain the palatal surface of the palatal element against the roof
of the user's mouth when the removable oral device is inserted into
the user's mouth. The method may also comprise forming the clasping
element by bending the clasping element and sizing it to contact
outer surfaces of at least one, two or three teeth.
[0045] Additional aspects, examples, embodiments and configurations
are described further below.
BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS
[0046] Certain configurations of methods of producing removable
oral devices are described below with reference to the accompanying
figures in which:
[0047] FIG. 1 is a side view of a palatal element of a removable
oral device, in accordance with certain examples;
[0048] FIG. 2 is another side view of a palatal element of a
removable oral device, in accordance with certain examples;
[0049] FIG. 3 is a perspective view of a palatal element of a
removable oral device, in accordance with certain
configurations;
[0050] FIG. 4 is a perspective view of a removable oral device
positioned within a tooth mold, in accordance with certain
examples;
[0051] FIG. 5 is a bottom view of a removable oral device
comprising a palatal element and clasping elements, in accordance
with some examples;
[0052] FIG. 6 is an illustration of a palatal element with grooves,
in accordance with certain examples;
[0053] FIGS. 7A and 7B are illustrations of a stackable/couplable
palatal elements in accordance with certain examples;
[0054] FIG. 8 is an illustration of a removable oral device, in
accordance with certain examples;
[0055] FIG. 9 is a schematic of a system for imaging an oral
cavity, in accordance with certain configurations; and
[0056] FIG. 10A is a top view of an impression tray, and FIG. 10B
is a bottom view of an impression tray, in accordance with certain
embodiments.
DETAILED DESCRIPTION
[0057] Various components are described below in connection with
methods which can be used to produce a removable oral device. The
exact number and ordering of the steps may vary depending on the
device to be produced, the production environment and the materials
used. The processes and materials provided below are merely
illustrative of many steps, materials and conditions which can be
used. Further, a clasping element can be present or can be omitted
from the removable oral device as desired.
[0058] In certain embodiments, the removable oral devices described
herein typically comprise a palatal element and an optional
clasping element. The palatal element can be configured to contact
a roof of a user's mouth at a palatal surface and may comprise a
body comprising a thickness configured to lower a vaulted area of
the roof of the mouth to decrease an overall oral volume of the
mouth to a first oral volume. As noted in more detail herein,
different areas of the clasping element may comprise different
materials and/or a different hardness as desired. The clasping
element can perform one or more functions including, for example,
facilitating removal of the removable oral device from the mouth
and/or assisting in retention of the palatal surface of the palatal
element against the roof of the user's mouth when the removable
oral device is inserted into the user's mouth. Various methods of
producing such removable oral devices are described below.
[0059] In certain examples, FIG. 1 shows a generalized illustration
of one configuration of a palatal element of a removable oral
device that can be produced using the methods described herein. The
palatal element 100 comprises a body 110 comprising a palatal
surface 112 and a tongue surface 114. Notwithstanding that many
different methods and devices can be used to produce the palatal
element 100, the palatal element 100 is generally designed so the
palatal surface 112 conforms or contours to the roof of a user's
mouth. A tongue surface 114 generally mirrors or replicates the
roof or palate shape of the user. In some instances, the palatal
element 100 has a thickness T1 (from the highest point or apex of
the palatal surface 112 to the lowest point of the tongue surface
114) at a medial portion of the palatal element 100. The thickness
T2 at an edge of the palatal element 100 is generally less than the
thickness T1. For example, the portions of the palatal element 100
which sit against or are adjacent to the upper teeth are typically
2.times., 3.times., 4.times. or 5.times. less thick than the
thickness T1 to provide a more comfortable fit in a user's mouth.
As noted in more detail herein, the thickness T1 may be adjusted or
adjustable as desired. Without wishing to be bound by any
particular theory or configuration, the thickness T1 can be
selected to decrease the overall oral volume of the mouth available
for chewing and/or to better position one or more sensors of the
palatal element 100 in an appropriate position. The amount by which
the oral volume is reduced is controlled generally by the thickness
T1 and may vary from user to user or depending on the particular
disorder to be treated, the particular condition to be monitored,
feedback received by application software or a coach and other
criteria. While the exact reduction in volume can vary, in some
examples, the thickness T1 is selected such that the oral volume is
reduced by 5% to about 50% (as compared to an original oral volume
where no removable oral device is present), more particularly
reduced by about 15% to about 35% or about 25% to about 35%. As
noted in more detail below, the thickness of the palatal element
may be altered with increasing temperature, by coupling one or more
additional palatal element bodies to the palatal element or by
other means. For example, an expandable bladder, e.g., an air
bladder or liquid bladder, can be present in the palatal element
100 to alter the overall volume of the palatal element 100.
[0060] In certain embodiments, the removable oral device comprising
the palatal element 100 can be used to reduce the overall volume of
the mouth to slow food intake. For example, the decrease in overall
volume provided when the palatal element 100 is inserted into a
user's mouth 100 permits smaller bites of food and/or lower overall
food volume per bite to be introduced into the mouth, which can
enhance mindful eating practices. This result can increase the
overall time it takes to ingest a particular volume of food, which
can promote increased satiety and an overall reduction in food
intake volume, e.g., fewer overall calories are consumed when the
removable oral device is present compared to the removable oral
device not being inserted into a user's mouth.
[0061] In some instances, the removable oral device comprising the
palatal element, e.g., one without a clasping element or one with a
clasping element, can be used in weight management and/or weight
control. For example, a user can insert the removable oral device
prior to eating, e.g., once per day, twice per day, three times per
day, once per week, five days per week, twice per week, every time
a user ingests food, etc. to assist in weight management. As noted
herein, when the removable oral device is in place, the overall
level of calories ingested during a particular eating session can
be reduced, which can result in weight loss and/or weight
management. In addition, by forcing the user to chew a particular
quantity of food for a longer period, mindful eating practices can
be adopted through behavioral modification. In certain
configurations, and as described in more detail in commonly
assigned applications bearing application numbers U.S. 62/477,760
and U.S. 62/477,766, the removable oral device can be used in
combination with a coaching platform or coaching based devices to
provide feedback and/or monitoring of the user's use of the
removable oral device and/or to assist in weight management. Such
coaching platforms may take the form of in-person sessions,
external sessions over a remote connection or automated sessions
retrieved by the user through one or more software applications on
a mobile device or other electronic device.
[0062] In some instances, the removable oral device comprising a
palatal element can be used until a user's body fat percentage or
body mass index (BMI) reaches a desired level. For example, the
removable oral device can be used in weight management with people
having a body mass index between 25 and 30. If desired, the
removable oral device could also be used with people whose body
mass index exceeds 30 or is under 25. In some examples, the
removable oral device can be used with human males comprising a
body fat percentage between 22-29% or exceeding 26% or with human
females comprising a body fat percentage of 31-39% or exceeding
31%. In some examples, the removable oral device frequency can be
reduced once the user's BMI or body fat percentage drops below a
selected level, e.g., below a BMI of 25 or below a body fat
percentage of 22% or 25% for human males and 31% for human females.
For example, weight maintenance can be attained by using the
removable oral device once per week or 2-3.times. per week rather
than using the removable oral device daily to assist in weight
loss.
[0063] In certain examples and referring to FIG. 2, a palatal
element 200 is shown that comprises areas 210, 220 and 230. Area
210 is designed to provide a desired thickness to reduce the
overall oral volume and comprises an apex 205, which is typically
the highest point of the palatal element 200. Areas 220 and 230 are
designed to be positioned adjacent to certain teeth and assist in
retention of the removable oral device in place. In certain
configurations, the material present in area 210 (as shown by box
212) may be harder than the materials present in areas 220, 230 (as
shown by boxes 222 and 232). The softness of the materials at areas
220, 230 can be the same or can be different. For example,
different materials can be used at the areas 220, 230 in the
production methods than the material used at area 210. In other
instances, post-production techniques, e.g., cross-linking,
hardening, etc. may be implemented to increase the hardness at the
area 210 as compared to a hardness at an area 220, 230. In some
examples, areas 220, 230 comprise softer materials to permit these
areas to function, at least to some degree, as a seal or gasket
that prevents foods or other materials from entering into any space
between a palatal surface of the palatal element and the roof of
the user's mouth. Depending on the particular materials used, the
hardness at the areas 220, 230 is at least 2.times., 3.times.,
4.times. or 5.times. less than the hardness at area 210. The
hardness at area 210 is generally less than that of glass or hard
plastics such that the area 210 can flex to some degree during
chewing of food.
[0064] Referring again to FIG. 1, the hardness of the materials may
decrease from a central area C1 toward the edges E1, E2. In some
examples, hardness may gradually decrease from C1 to E1, E2,
whereas in other instances an interface can be present between
various portions of the palatal element where the softer materials
meet the harder materials. In some embodiments and referring again
to FIG. 2, the material present in area 210 (as shown by box 212)
may be harder, e.g., may have a higher Vickers Hardness value (HV),
than the materials present in at least some areas within areas 220,
230 (as shown by boxes 222 and 232). While the exact methodology
used to determine a HV value can vary, suitable methods typically
involve indenting the test material with a diamond indenter under a
selected load, e.g., 30 kg of force (kgf), and measuring the depth
of the indentation. The indentation depth can be correlated to
materials hardness using suitable lookup tables or calibration
curves. Commercial instruments to determine Vickers hardness values
are available from Shimadzu (Japan) and LECO (Japan). In some
instances, the protocols described in ASTM E384-16 entitled
"Standard Test Method for Microindentation Hardness of Materials"
can be followed to determine Vickers hardness values. The
hardness/softness of the materials at areas 220, 230 can be the
same or can be different. In some examples, areas 220, 230 comprise
softer materials (compared to the hardness of the material at area
210) to permit these areas to function, at least to some degree, as
a seal or gasket that prevents, foods or other materials from
entering into any space between a palatal surface of the palatal
element and the roof of the user's mouth. Depending on the
particular materials used, the hardness at the areas 220, 230 can
be at least 2.times., 3.times., 4.times. or 5.times. less than the
hardness at area 310. For example, the Vickers hardness value (HV)
at areas 220, 230 can be at least 5% less, at least 10% less, at
least 20% less, at least 30% less, at least 40% less or at least
50% less than the HV value at the area 210. The hardness at area
210 is generally less than that of glass or hard plastics such that
the area 210 can flex to some degree during chewing of food. For
example, in some instances, the HV at the apex 205 may be 20 HV or
more, whereas the HV at each of the edges 220, 230 can
independently be less than 20 HV. In other examples, the HV value
at the apex 205 can be 10 HV or more and the value at the edges
220, 230 can be less than 10 HV. In other configurations, the HV at
the apex 205 can be 10 HV or more and the value at the edges 220,
230 can be less than or equal to 5 HV. The exact level of hardness
used may vary from subject to subject. For example, certain
individuals may find hard apex areas to be uncomfortable, and the
material hardness at the apex can be lowered for those subjects by,
for example, reducing the level of cross-linking in the polymeric
materials used to produce the palatal element 200.
[0065] In some embodiments, the material used at the edges may be
the same or may be different than material present at the apex of
the palatal element and different techniques can be used to couple
the material at the edges to material at the apex. For example, the
material at the edges can be the same material but it may be
cross-linked to a lesser degree to be softer than the material at
the apex section of the palatal element. In other examples, a
different material is used for the edges and is coupled to other
material of the palatal element through one or more cross-linkers.
For example, a central portion or apex portion of the palatal
element may first be built up, e.g., using printing,
sprinkle-and-pour techniques or other techniques, and then the
edges can be placed adjacent to the central portion and couple to
the central portion through one or more chemical bonds. The edges
typically integrate with the central portion without the need to
use an adhesive or other material to retain the edges to the
central portion. Where two different materials are used, there is
generally no discernible interface between the materials which
might be obtrusive or uncomfortable. For example, layers of the
apex material can be built up using a first material, and a second
material can then be coupled to the first material to provide the
edges of the palatal element.
[0066] In some embodiments, the material present in the palatal
element may be an acrylic, a polycarbonate, a polyolefin, a
thermoplastic polymer, a thermoset polymer or combinations thereof.
If desired, the material may comprise elastomers, elastomeric
fibers or other materials to alter the overall hardness of one or
more areas of the palatal element. The materials can be
cross-linked or cured by sprinkling or mixing a cross-linker with
the material either pre-use or post-use. For example, a mold of the
user's mouth can be used with the material to provide a palatal
element. The material can be added to the mold (in one or more
desired areas) and then cross-linked by sprinkling a cross-linker
onto the added material in the mold. In some examples, the palatal
surface and/or tongue surface can be smooth to prevent food from
sticking to the removable oral device. If desired, however, the
surface may be bumpy or comprise ridges or other features to mimic
the tongue feel when the tongue is placed against the roof of the
user's mouth. In other instances, the palatal element may comprise
one or more coatings including, but not limited to, anti-bacterial
coatings, non-stick coatings or coatings which may impart color or
ornamental designs to the palatal element. In some embodiments,
each area of the palatal element may comprise an acrylic material
including polyacrylates, methacrylates and the like. In some
embodiments, one or more areas of the may comprise Silident
materials, clays, alginates, or other materials which can generally
retain their shape during eating forces.
[0067] In some examples, the material at the edges of the palatal
element may be thermally sensitive and can soften to an even
greater degree at mouth temperatures than when the palatal element
is outside of the mouth. For example, the Vickers Hardness of the
material at the edges can be selected to decrease when the
removable oral device is inserted into the mouth and reaches the
temperature of the mouth compared to the Vickers hardness of the
edges when the palatal element is at room temperature. In some
embodiments, the Vickers hardness of the material of the edges
decreases at least 5%, at least 10% or at least 20% at about 37
degrees Celsius compared to the Vickers hardness at room
temperature (about 25 degrees Celsius).
[0068] In certain examples, a perspective view of a palatal element
is shown in FIG. 3. The palatal element 300 comprises a body 310
with sides 312, 314, 316 and 318. Side 312, e.g., an anterior side,
generally is adjacent and/or contact inner surfaces of the anterior
teeth. Side 314, e.g., a posterior side, is positioned in the back
of the mouth when the removable oral device is inserted. Side 316
can be positioned adjacent to the inner surfaces of tooth numbers
1-4 (or 2-4 when the wisdom teeth have been removed) when the
removable oral device is inserted. Side 318 can be positioned
adjacent to the inner surfaces of tooth numbers 13-16 (or 13-15
when the wisdom teeth have been removed) when the removable oral
device is inserted. The length L1 of the body 310 may vary and is
generally designed to be large enough so the body 310 provides a
desired oral volume reduction but is not so large that a user may
gag or have difficulty breathing when the removable oral device is
inserted. As noted herein, the sides 316, 318 may comprise a softer
material than material present at an apex of the palatal element
300, e.g., the Vickers hardness at the edges 316, 318 may be at
least 2.times., 3.times., 4.times. or 5.times. less than the
hardness at an apex area. For example, the Vickers hardness value
(HV) at the edges 316, 318 can be at least 5% less, at least 10%
less, at least 20% less, at least 30% less, at least 40% less or at
least 50% less than the HV at the apex area of the palatal element
300.
[0069] In some examples, some portion or the anterior side and/or
posterior side can be removed to facilitate a better user
experience with the removable oral device. For example, a volume of
the palatal element toward the anterior side 312, e.g., the volume
from the line 325 forward toward the anterior side 312 can be
removed or reduced, e.g., by trimming, sanding, cutting, etching,
etc., to reduce lisping. In certain embodiments, about 1-10% of the
volume from the anterior side 312 can be removed to assist in
reduction of lisping when the removable oral device is in place. If
desired, a crescent shape (or other shape) may be provided at the
anterior side 312 to reduce lisping. In some examples, trimming the
posterior side 318 of the device in a crescent shape can be
performed to eliminate or reduce contact with the soft palate to
address individuals with heightened gag reflex. For example, a
posterior volume from line 330 toward the posterior side 314 can be
removed to reduce the likelihood of gagging when the removable oral
device is present in the mouth. In some examples, a crescent shape
(see FIG. 5) or other non-linear shape may be provided at the
posterior side to reduce gagging. In other instances, the palatal
element can be trimmed or cut into various shapes for purely
ornamental reasons that might increase the overall aesthetic
appearance of the palatal element but generally does not provide
any particular function. In certain embodiments, about 1-15% of the
volume from the posterior side 314 can be removed to assist in
reducing the likelihood of gagging. A palatal element can then be
trimmed or shaped as desired to provide a desired overall volume
reduction while at the same time minimizing or reducing the
likelihood of lisping and/or gagging. In addition, the palatal
element can be trimmed or shaped to provide a more aesthetically
pleasing palatal element rather than one which imparts any
particular anti-lisping function or other function.
[0070] In certain configurations, the removable oral devices
described herein may also comprise a clasping element. As noted
herein, the clasping element is optional but may be present to
assist removal of the palatal element from the user's mouth.
Referring to FIG. 4, a perspective view of a removable oral device
400 comprising a palatal element 410 and a clasping element 420 is
shown positioned around a tooth mold 405. The clasping element 420
is generally configured with a support element or wire that is
embedded within a material such that the wire itself does not
directly contact the outer surfaces of the teeth. While the
clasping element may be configured as a wire or wires in some
instances, in other cases the clasping element may comprise a
plastic or flexible moldable material etc., or other non-metal
based materials. In some examples, the clasping element may
comprise chromium-nickel alloys such as, for example, Elgiloy
materials which are cobalt-chromium-nickel alloys. In other
examples, the clasping element may comprise titanium, titanium
alloys, nickel titanium materials such as Nitinol, etc. In some
embodiments, the material of the clasping element is generally
inert so that it does not tarnish, rust, corrode or otherwise
degrade during use of the removable oral device. In certain
configurations, some portion of the wire may directly contact the
rear surface of the back teeth to assist in retention of the
palatal element 410 against the roof of a user's mouth.
[0071] In certain configurations, the wire of the clasping element
may be a continuous wire which runs from one side of the palatal
element 410 to the other or two or more separate wires can be
present with one wire being present in a respective clasping
element. For example and referring to FIG. 5, a clasping element
510 comprises a wire 515 and associated material 520 on some
portion of the wire. Another clasping element 550 comprises a wire
555 and associated material 560 on some portion of the wire 555.
Some portion of the wires 515, 555 is also embedded within a body
of a palatal element 505. The material 520, 560 generally rests
against outer surfaces of the teeth when the palatal element 505 is
engaged to the roof of the mouth. The wires 515, 555 can assist in
removal of the removable oral device from the mouth and/or assist
in retaining the removable oral device in place. For example,
surface tension between a palatal surface of the palatal element
505 and the roof of a user's mouth can "lock" the palatal element
505 to the roof of the mouth. The wires 515, 555 can provide
leverage to assist in breaking of the surface tension and removal
of the removable oral device from the mouth. An optional sensor 580
is also shown as being embedded in the palatal element 505.
Illustrative sensors are described, for example, in the commonly
assigned patent applications incorporated herein by reference.
While two clasping elements 510, 550 are shown in FIG. 5, only a
single clasping element may be present if desired or no clasping
elements may be present at all.
[0072] In certain configurations, the palatal element and/or
clasping element(s) of the removable oral devices are designed to
not permanently retain the removable oral device in a user's mouth.
In particular, the palatal element may lock or be held in place to
the roof of the mouth without the user of any fasteners. In other
examples, the clasping element can be configured to provide a
friction fit against the outer surfaces of the back teeth, e.g.,
the clasping element is designed to contact the outer surfaces of
tooth numbers 1-4 or 2-4 and/or tooth numbers 13-16 or 13-15. In
some instances, the clasping element may comprise one or more
portions which are positioned between two or more of tooth numbers
2-4 and/or tooth numbers 14-16 to assist in anchoring of the
palatal element to the roof of the user's mouth. The removable oral
device generally is designed to lack any wires, supporting element
or anchoring elements which extend around, through or near tooth
numbers 5-12 such that the clasping element does not alter the
position of the teeth in use. As noted herein, the clasping element
is also generally not designed to retain the teeth in any
particular position. In some configurations, the removable oral
device does not include any clasping element, supporting element,
wire, etc. that engage the anterior teeth, e.g., outer surfaces of
tooth numbers 5-12 or 4-11 do not contact the clasping element.
[0073] In certain embodiments, a removable oral device comprises a
palatal element coupled to a clasping element. As noted herein, the
palatal element is configured to contact a roof of a user's mouth
at a palatal surface and can be configured to lower a vaulted area
of the roof of the mouth to decrease an overall oral volume of the
mouth to a first oral volume. The body of the palatal element may
comprise a variable hardness across a tongue surface of the body.
In some examples, the clasping element is configured to assist in
removal of the removable oral device when the removable oral device
is inserted into the user's mouth. In certain configurations, the
tongue surface of the palatal element is compressible at an edge of
the palatal element adjacent to the clasping element and is
substantially non-compressible at an area adjacent to the roof of
the user's mouth. For example, surfaces adjacent to the side edges,
anterior edges and/or posterior edges may be soft and compressed
with force from the tongue, whereas surfaces in-line with the apex
surface may be substantially non-compressible by force from the
tongue. It may be desirable to select materials for the edges that
have a Vickers hardness soft enough to permit tongue forces to
compress the material. In addition, various techniques can be used
in the production process to provide areas with a different Vickers
hardness. It may also be desirable to select materials for an apex
or central portion of the palatal element to have a Vickers
hardness high enough such that substantially no compression of the
apex or central portion occurs under tongue force or tongue
pressure.
[0074] In some embodiments, the palatal element may comprise a
temperature sensitive thermally expandable material configured to
increase its overall volume at a body temperature of the user. For
example, certain hydrogels or other gel or sol based materials may
thermally expand with increasing temperature, which can act to
increase the overall volume occupied by the palatal element. This
configuration can result in less of a reduction in oral volume when
the removable oral device is initially inserted and an increased
reduction in oral volume during continued use of the removable oral
device. In some examples, the thermally expandable material can be
selected so that its overall volume increases by at least 5%, at
least 10%, at least 15% or at least 20% when the palatal element
temperature increases from around room temperature, e.g., about 25
degrees Celsius, to around body temperature, e.g., about 37 degrees
Celsius. The thermally expandable material may be present, for
example, in an internal bladder or compartment present in the
palatal element and may or may not be accessible by the tongue
during use of the removable oral device. Illustrative thermally
expandable materials include, but are not limited to, thermally
expandable methyacrylates, thermally expandable epoxy materials,
thermally expandable hydrogels, thermally expandable aerogels and
other similar materials.
[0075] In certain examples, the palatal element may comprise one or
more grooves, holes or other features present on a tongue surface
or a palatal surface as desired. For example and referring to FIG.
6, a palatal element 600 may comprise one or more grooves such as
grooves 610, 620, 630 and 640. The exact number of grooves can vary
from one to about ten, for example. The grooves can assist in
breaking any seal between the palatal surface and the roof of a
user's mouth and/or can decrease the overall weight of the device.
If desired, the grooves can be replaced with holes or other
features. The grooves, holes, etc. generally do not penetrate into
or through the tongue surface of the palatal element 600 to avoid
materials such as food from becoming trapped in the palatal element
600. As noted herein, where grooves or other features are present,
one or more sides of the palatal element 600 may also comprise soft
surfaces or the palatal element may comprise a body with variable
hardness. To provide the grooves or other features, a suitable mold
that comprises features to impart grooves can be used. In other
instances, post-production techniques can be implemented to provide
the grooves or other features in one or more surfaces of the
palatal element.
[0076] In certain configurations, the removable oral device may be
modular to permit a user to assemble two or more palatal elements
to each other. Referring to FIGS. 7A and 7B, two palatal elements
710, 720 are shown. A palatal surface of the element 720 may snap
into or engage a tongue surface of the element 710 to retain the
palatal elements 710, 720 to each other for some period. In certain
configurations, the palatal element 720 may comprise projections or
bosses 722, 724 which can engage corresponding holes or apertures
(not shown) in an under surface of the palatal element 710 to
retain the element 720 to the element 710. Coupling of the element
720 to the element 710 reduces the overall oral volume to a second
oral volume which is less than that provided by either of the
elements 710, 720 alone. One of the palatal elements 710, 720 may
comprise one or more clasping elements as described herein to
assist in retention of the assembly to the roof of the mouth of a
user. If desired, a third palatal element, fourth palatal element,
etc. can be coupled to further reduce the oral volume. Modular
palatal elements may be particularly desirable for initial weight
loss and downstream weight management. For example, both palatal
elements 710, 720 can initially be used to provide a greater volume
reduction and assist in weight loss from reduced caloric intake.
Once the user reaches their weight goal or their BMI or body fat
drops below a desired level, then one of the palatal elements 710,
720 can be removed to assist the user in maintaining their current
weight using only the single palatal element during ingestion of
food. In the alternative, the use of multiple combined palatal
elements can force a user to ingest a particular quantity of food
over a desired period. For example, where a user eats food too
quickly even with the removable oral device inserted, a second
palatal element can be coupled to the first palatal element to
provide a further reduction in oral volume to increase the overall
eating time for the same quantity of food.
[0077] In some instances, the removable oral devices described
herein can be produced by printing, e.g., three-dimensionally
printing, a removable oral device using a first material. For
example, a removable oral device comprising a palatal element can
be three-dimensionally printed using a three dimensional printer
and suitable materials which can be printed and can provide desired
physical properties, e.g., biocompatible inks/materials or other
suitable materials can be used. The template for the palatal
element can be obtained using numerous methods (as noted below) and
used by a system comprising the three dimensional printer to print
the palatal element. The three-dimensional printer typically
includes one or more print heads and a stage or support that can
receive material from the print heads to form the printed palatal
element. Successive layers are built upon the support to provide
the printed palatal element. The resulting printed palatal element
can be shaped or modified to provide a desired final shape or size
if desired. For example, some portion of the anterior or posterior
sides of the printed palatal element can be removed. In some
examples, some portion of an anterior side, e.g., a side toward the
front teeth, can be removed to reduce lisping. In other examples,
some portion of a posterior side, e.g., a side toward the back of
the throat, can be removed to avoid or deter gagging. If desired,
however, these portions of the palatal element can be omitted
during the printing process to avoid post-printing shaping or
trimming steps.
[0078] In certain examples, the exact nature and type of
three-dimensional printing used to produce the components of the
removable oral device may vary. Illustrative three-dimensional
printing technologies include, but are not limited to, selective
laser sintering (SLS), fused deposition molding (FDM), laminate
object manufacturing (LOM), rapid prototyping, and
three-dimensional inkjet printing. Three-dimensional printing
methods using digital light processing (DLP) or an injection
through a series of tiny nozzles or a single nozzle may use
photo-curable materials which can be cured by UV/Visible light.
These two methods are rapid, low cost, high resolution, and easy to
use. Three-dimensional removable oral devices can be produced using
ink-jet printing techniques that can use several different
materials, e.g., from different reservoirs or cartridge, to provide
a photo-curable liquid compositions which can be cured by exposure
to UV/Visible light. The photo-curable "ink" in the ink-jet
printing process is provided through one or more nozzles on a
support stage with a pattern defined by a computer aided design
(CAD) file or other three-dimensional coordinates. In one exemplary
illustration, successive layers of the palatal element can be
"built up" by placing individual layers on the printer support and
curing, at least to some degree, the printed layer prior to
addition of successive layers. Layers can be added in individual
areas until a desired final shape is reached. In some instances, a
material with a different hardness can be printed at the edges of
the palatal element to provide softer edges. In alternative
configurations, the material at the edges may comprise the same
basic material as present at the apex portion of the palatal
element, but a different cross-linker, or lower amounts of the same
cross-linker, can be disposed at the edges to provide the softer
edges.
[0079] In some embodiments, the final three-dimensionally printed
removable oral device can then be washed or treated with one or
more other materials if desired, e.g., one or more coatings or
other materials can be applied to the printed palatal element,
clasping element or both. In one three-dimensional printing
technique using digital light processing, the photo-curable liquid
can be placed in a reservoir. Exposure of certain areas to the
curing light can provide layers which can be used to build up the
removable oral device to a desired thickness. Once a layer has been
cured by UV/Visible light, a building platform moves in the
z-direction depending on the thickness of the layer. This process
is repeated until all layers are formed and/or a desired shape is
formed. Illustrative three-dimensional printers include, but are
not limited to, those commercially available from Objet or Master,
those supplied by Carima and The Form 1 supplied by Formlabs.
[0080] In some examples, the materials used by the
three-dimensional printer may be photo-curable, heat curable, UV
curable or cured by adding one or more external curing agents to
the printed palatal element to harden the materials (at least to
some degree). The exact materials used include, but are not limited
to, acrylates, methacrylates, acrylic polymers and co-polymers,
functionalized bisphenol A methacrylates such as a monofunctional
bisphenol A dimethacrylate or a difunctional bisphenol A
dimethacrylate, a diglycidyl methacrylate ester of bisphenol-A or a
bisphenol-A diglycidyl ether and other materials. In some examples,
the printed palatal element of the removable oral device may
comprise one or more of ethylene glycol dimethacrylate, diethylene
glycol dimethacrylate, triethylene glycol dimethacrylate,
polyethylene glycol dimethacrylate, 2,2 bis[4-(methacryloxy
ethoxy)phenyl]propane, tricyclodecane dimethanol dimethacrylate,
1,10-decanediol dimethacrylate, 1,6-hexanediol dimethacrylate,
1,9-nonanediol dimethacrylate, neopentyl glycol dimethacrylate,
2-hydroxy 1-3 dimethacryloxy propane, trimethylolpropane
trimethacrylate, ethoxylated trimethylol propane trimethacrylate,
ditrimethyolpropane tetramethacrylate, tris (2-hydroxy
ethyl)isocyanurate trimethacrylate, dipentaerythritol
pentamethacrylate, ethoxylated pentaerythritol tetramethacrylate,
propoxylated glyceryl trimethacrylate, propoxylated
trimethylolpropane trimethacrylate, and a polyester dendrimer. The
exact material used, or combinations of the materials used, can be
selected to provide a palatal element which provides sufficient
hardness to permit chewing but is not so hard as to be
uncomfortable in the mouth. For example, the material can be cured
to provide a feel similar to the native roof of the mouth. If
desired, the printed palatal element may comprise grooves, bumps or
other features present on a tongue surface as described the
SCIINTAK-700100 application. Such features may be provided during
the printing process or added post-printing.
[0081] In certain examples, the clasping element of the removable
oral device may also be printed or the palatal element can be
printed with the clasping element or elements present on the
printer support. For example, a clasping element in the form of a
metal wire (or a support material other than metals) can be present
on the printer stage, and the palatal element can be printed onto
the clasping element to provide the removable oral device with an
embedded wire as a clasping element or where a portion of the wire
of the clasping element is embedded within the palatal element.
[0082] In some examples, the printed palatal element can be heat
cured by placing it in an oven to harden the body of the palatal
element. If desired, heat tape, shielding tape or other materials
can be placed at the edges of the palatal element to prevent
hardening of these areas to the same degree as an apex portion of
the body. In other examples, one or more curing agents can be
deposited onto the entire body of the palatal element or just at
apex areas to provide softer edges when the palatal element is
cured.
[0083] In certain examples, one or more photo-curing agents can be
added to the printed palatal element (or clasping element or both)
or may be present in the "ink" used to print the palatal element.
For example, the polymeric material of the palatal element can be
mixed with a photo-curing agent and the mixture is deposited in
additive layers to form the palatal element. Illustrative
photo-curing agents include, but are not limited to, acetophenone,
anisoin, anthraquinone, (benzene)tricarbonylchromium, benzil,
benzoin, benzoin ethyl ether, benzoin isobutyl either, benzoin
methyl ether, benzophenone, 3,3',4,4'-benzophenonetetracarboxylic
dianhydride, 4-benzoylbiphenyl,
2-benzyl-2-(dimethylamino)-4'-morpholinobutyrophenone,
4,4'-bis(diethylamino)benzophenone,
4,4'-bis(dimethylamino)benzophenone, camphorquinone,
2-chlorothioxanthen-9-one,
(cumene)cyclopentadienyliron(II)hexafluorophosphate,
dibenzosuberenone, 2,2-diethoxyacetophenone,
4,4'-dihydroxybenzophenone, 2,2-dimethoxy-2-phenylacetophenone,
4-(dimethylamino)benzophenone, 4,4'-dimethylbenzyl,
2,5-dimethylbenzophenone, 3,4-dimethylbenzophenone,
4'-ethoxyacetophenone, 2-ethylanthraquinone, ferrocene,
3'-hydroxyacetophenone, 4'-hydroxyacetophenone,
3-hydroxybenzophenone, 4-hydroxybenzophenone, 1-hydroxycyclohexyl
phenyl ketone, 2-hydroxy-2-methylpropiophenone,
2-methylbenzophenone, 3-methylbenzophenone, methylbenzoylformate,
2-methyl-4'-(methylthio)-2-morpholinopropio-phenone,
phenanthrenequinone, 4'-phenoxyacetophenone, thioxanthen-9-one,
triacrylsulfonium hexafluoroantimonate salts, triarylsulfonium
hexafluorophosphate salts, 4,6-trimethylbenzoyldiphenylphosphine
oxide, 2,6-dimethyoxybenzoyldiphenylphosphine oxide,
2,6-dichlorobenzoyldiphenylphosphine oxide,
2,4,6-trimethylbenzoylmethoxyphenylphosphine oxide,
2,4,6-trimethylbenzoylethoxyphenylphosphine oxide,
2,3,5,6-tetramethylbenzoyldiphenylphosphine oxide, and benzoyl
di-(2,6-dimethylphenyl)phosphonate. Examples of the
bisacylphosphine oxides include
bis-(2,6-dichlorobenzoyl)phenylphosphine oxide,
bis-(2,6-dichlorobenzoyl)-2,5-dimethylphenylphosphine oxide,
bis-(2,6-dichlorobenzoyl)-4-prophylphenylphosphine oxide,
bis-(2,6-dichlorobenzoyl)-1-naphthylphosphine oxide,
bis-(2,6-dimethoxybenzoyl)-2,4,4-trimethylpentylphosphine oxide,
bis-(2,6-dimethoxybenzoyl)-2,5-dimethylphenylphosphine oxide,
bis-(2,4,6-trimethylbenzoyl)phenylphosphine oxide,
(2,5,6-trimethylbenzoyl)-2,4,4-trimethylpentylphosphine oxide and
those compounds commercially available from Dow Chemical Company as
UVI 6950, UVI 6970, UVI 6974, UVI 6976, and UVI 6990.
[0084] In certain examples, the printed palatal element (or the
clasping element or both) may comprise fillers, particles, powders,
reinforcing materials, etc. to impart overall desired physical
properties to the removable oral device. For example, silica based
powders, fillers, fibers, etc. can be added to the removable oral
device. In other instances, carbon fibers or particles can be added
to the palatal element to alter its overall strength and/or weight.
Pigments, colorants, dyes, texturizing agents, UV stabilizers, or
other materials may also be present. If desired, suitable
ornamental features, logos, etc. may also be printed or otherwise
provided on the palatal element, clasping element or both.
[0085] In some examples, two different materials can be used to
print the removable oral device. For example and referring to FIG.
8, a first material can be used to print the body at or adjacent to
an apex surface 810, e.g., a surface adjacent to the palate and
opposite a tongue surface of the palatal element, and a second
material can be used to print the body at the edges 812, 814. It
may be desirable, for example, to print the edges 812, 814 using a
softer material to increase the overall comfort of the removable
oral device in the mouth and/or reduce lisping. If desired, some
portion of the clasping elements 820, 830 can also be printed. For
example, material can be printed onto the wire support of the
clasping elements 820, 830. The exact shape of the front edge 815
and the back edge (not shown) may vary as noted below.
[0086] In some examples, one or more sensors can be disposed on the
printer support prior to printing or during printing to embed the
sensor with the printed palatal element. Such sensors can be
disposed in an automated manner or manually during the printing
process. Other devices such as bladders, electrodes, etc. can also
be added to the palatal element, the clasping element or both as
the device is being printed. Where sensors (or other electrical
components) are present, the printing process and/or curing
conditions may desirably be performed at temperatures and
conditions where damage to the sensors (or other electrical
components) does not occur. If desired, shielding tape, heat tape,
etc. may be disposed over areas comprising the sensors (or other
electrical components) to prevent damage by exposure to heat and/or
UV/Visible radiation. Illustrative sensors include, but are not
limited to, a camera, an electrode, a bar code reader, a processor,
an optical transmitter, an optical receiver, a RFID tag, a
piezoelectric sensor, an accelerometer, a chewing sensor, etc.
Additional sensors and electrical components can also be included
in the palatal element as desired.
[0087] In some examples, three-dimensional printing techniques can
be used to print a molding plate which the user can insert into
their mouth to provide a mold of their mouth. For example and as
noted in more detail below, the printed molded plate can be
tailored or customized for the user and used in combination with an
impression material, e.g., an alginate or other materials, to
provide a mold of the upper mouth of the user.
[0088] In another configuration of producing a removable oral
device comprising a palatal element and a clasping element, a
method comprises imaging an oral cavity of a human. The imaged oral
cavity can then be used to provide a removable oral device from the
imaged oral cavity. The imaging of the oral cavity can be performed
internally or externally as desired. The produced removable oral
device comprises a palatal element coupled to a clasping element,
in which the palatal element is configured to contact a roof of a
user's mouth at a palatal surface. The clasping element, when
present, is configured to assist in removal of the palatal element
from the mouth and/or to retain the palatal surface of the palatal
element against the roof of the user's mouth when the removable
oral device is inserted into the user's mouth.
[0089] Various different methods and systems can be used to image
the oral cavity of the mouth. In some examples, a user may insert a
probe or device into their mouth to permit scanning of the
surfaces, including the palatal surfaces, to provide a
two-dimensional or three-dimensional representation of the user's
mouth. For example, a camera head can be inserted into the mouth
and used to capture video or still images of the mouth surfaces.
The camera images may be used to digitally reconstruct a
representation of the oral cavity, which can be used to provide the
removable oral device, e.g., can be used to print the removable
oral device. For example and referring to FIG. 9, a system which
comprises a probe 910 can be electrically coupled to a processor
920, e.g., in a wired or wireless manner, which is used to provide
a three-dimensional image from the measurements of the probe 910.
As noted in more detail in the commonly assigned U.S. 62/477,766
incorporated herein by reference, the combination of oral scanning
and three-dimensional printing can permit real-time production of a
removable oral device for a user, e.g., in a health care provider's
office or at a point of sale kiosk. If desired, imaging can instead
be performed in an external manner by placing a probe adjacent to
outer surfaces of the cheeks and imaging from the outside of the
user's mouth.
[0090] In certain configurations, the exact nature of the probe 910
can vary. In some examples, the probe 910 comprises an ultrasound
scanner head which can be used to obtain detailed images of the
oral cavity. These detailed images can be used to provide
three-dimensional coordinates which are used to provide the
removable oral device. In other instances, the probe 910 may
comprise a camera or image head such as a video camera,
charge-coupled device, photo-diode camera or other suitable cameras
which can capture still or moving images from the oral cavity. The
captured images can be used to provide three-dimensional
coordinates which are used to provide or produce the removable oral
device. In some examples, the probe 910 is configured to only
measure the upper surfaces of the oral cavity including the palatal
surfaces. Various different types of imaging can be used including,
but not limited to, panoramic imaging, X-rays, CT scanning,
magnetic resonance imaging, ultrasound imaging, infrared imaging,
etc. While not required, the imaging desirably is one which uses
lower energy imaging, e.g., no X-rays, to avoid undue exposure to
potential ionizing radiation.
[0091] In certain configurations, the production methods described
herein can use the image to produce the removable oral device with
areas of the body adjacent to the clasping element being softer
than other areas of the body. In other configurations, the method
comprises imaging the oral cavity using an image head electrically
coupled to a wireless device. For example, the probe can wirelessly
transmit images or coordinates to a mobile device such as a phone,
laptop or tablet to permit a user to obtain and take the
coordinates and use them to print or otherwise produce a removable
oral device at a later time. In some embodiments, the wireless
images can be provided to a pharmacy which can produce the
removable oral device using three-dimensional printing or other
techniques. Use of the removable oral device for weight management
can be subject to federal regulation and may require a prescription
from a physician. The probe can permit a user to image their oral
cavity and then transfer that information to the pharmacy which can
fill the prescription by producing the removable oral device or
ordering it from a third party authorized to fill
prescriptions.
[0092] In some examples, a user may interact with a kiosk or system
which images their oral cavity and provides three-dimensional
coordinates based, in part, on user information such as height,
weight, etc. As described in more detail in U.S. 62/477,766, the
user can stand on a platform or scale and enter their height into
the system. The user may then insert the probe into their mouth (or
hold it adjacent to their mouth) to scan their mouth and provide
three-dimensional coordinates from the mouth scan. Based on the
user's information, the system can select an overall thickness for
the removable oral device. For example, where the user is 5-10
pounds over their target weight, e.g., 5-10 pounds above a body
mass index of 25, the system may use the image to provide a
removable oral device with suitable dimensions to reduce the oral
volume by about 15% when the device is in place. Where the user is
10-20 pounds over their target weight, e.g., 10-20 pounds above a
body mass index of 25, the system may use the image to provide a
removable oral device with suitable dimensions to reduce the oral
volume by about 20% when the device is in place. Where the user is
20-30 pounds over their target weight, e.g., 20-30 pounds above a
body mass index of 25, the system may use the image to provide a
removable oral device with suitable dimensions to reduce the oral
volume by about 25% when the device is in place. Where the user is
considered obese or morbidly obese, the system may use the image to
provide a removable oral device with suitable dimensions to reduce
the oral volume by about 30-35% when the device is in place. As the
user loses weight using the device, they can return and obtain an
updated removable oral device which has a lower thickness if
desired. In this manner, the system can tailor or customize the
removable oral device based on oral images and based on a user's
physical characteristics and/or desired weight management goals. In
some examples, the system may use bioelectrical impedance to
measure the user's body fat percentage, and based on the measured
body fat percentage, select a thickness for the removable oral
device. This thickness can be different with higher palatal element
thicknesses typically desired where higher body fat percentages are
identified, e.g., for body fat percentages above 25% in men and 32%
in women, a thickness which reduces the overall oral volume by
about one-third can be used.
[0093] In some examples, the probe used to capture the images may
plug into or interface with a phone, mobile device, tablet,
wearable device or other device to permit the user to obtain the
images of their oral cavity at home. The obtained oral images can
then be transmitted to a third party to produce the removable oral
device. If desired, physical parameters of the user, e.g., height,
weight, gender, age, etc. can also be considered during production
of the removable oral device. The probe may plug into a USB port, a
micro-USB port, Lightning port, an Ethernet port, etc. of the
mobile device or may wirelessly transmit images to the mobile
device or other electronic device.
[0094] In another configuration, a method of using a removable oral
device comprises imaging an oral cavity of a human using an image
head configured to receive a disposable cover, and printing a
removable oral device from the imaged oral cavity using a first
material. The printed removable oral device comprises a palatal
element coupled to an optional clasping element, in which the
palatal element is configured to contact a roof of a user's mouth
at a palatal surface, and wherein the palatal element comprising a
body comprising a thickness configured to lower a vaulted area of
the roof of the mouth to decrease an overall oral volume of the
mouth to a first oral volume. The clasping element, when present,
can be configured to assist in removal of the removable oral device
from the mouth and/or to retain the palatal surface of the palatal
element against the roof of the user's mouth when the removable
oral device is inserted into the user's mouth.
[0095] In certain configurations, the method comprises printing
areas of the body adjacent to the clasping element using the imaged
oral cavity and a second material softer than the first material.
In other instances, the method comprises printing a second
removable oral device from the imaged oral cavity, wherein the
second removable oral device comprises a second palatal element
comprising a second body comprising a thickness configured to lower
a vaulted area of the roof of the mouth to decrease an overall oral
volume of the mouth to a second oral volume less than the first
oral volume. As noted in more detail herein, one or more sensors,
electrodes or other devices can be embedded in the removable oral
device during the printing process. The removable cover is
configured to engage an image head through a friction fit and
permits many different users to use the same image head without the
need to sanitize or clean the image head between users. In some
examples, the cover is transparent to the particular methods used
to image the oral cavity, e.g., does not absorb or deflect
ultrasound waves, light, etc. If desired, the cover may comprise a
thickness and/or shape which mimics that of the palatal element of
the removable oral device so the image head can be used to assess
the quality of the fit of a potential removable oral device prior
to printing. In some examples, the cover may be elastomeric or
compressible to assist in obtaining a desired palatal shape for
production of the palatal element. Adjustments can be made based on
the feedback before the removable oral device is printed. In some
examples, the method comprises three-dimensionally printing the
palatal element using a photo-curable material. In other examples,
the method comprises disposing one or more wires on a printer
support as the clasping element and printing the photo-curable
material into the printer support comprising the one or more wires
to provide the removable oral device. In some examples, the method
comprises photo-curing the printed palatal element using UV/Visible
light. In certain embodiments, the method comprises printing each
of the palatal element and the clasping element using a
photo-curable material. In some instances, the method comprises
three-dimensionally printing the removable oral device using an
inkjet three-dimensional printer. In certain examples, the method
comprises three-dimensionally printing the removable oral device
using digital light processing.
[0096] In another configuration, a method may comprise imaging an
oral cavity of a human, printing a mold from the imaged oral
cavity, and using the printed mold to provide a removable oral
device comprising a palatal element coupled to a clasping element.
The palatal element is configured to contact a roof of a user's
mouth at a palatal surface, the palatal element comprising a body
comprising a thickness configured to lower a vaulted area of the
roof of the mouth to decrease an overall oral volume of the mouth
to a first oral volume. The clasping element is configured to
assist in removal of the removable oral device from the mouth
and/or to retain the palatal surface of the palatal element against
the roof of the user's mouth when the removable oral device is
inserted into the user's mouth.
[0097] In some configurations, the method comprises using an image
head configured to receive a disposable cover to image the oral
cavity. In other examples, the method comprises injecting a
material into the printed mold to provide the removable oral
device. The injected material may be, for example, any of those
materials described in connection with three-dimensional printing
or other materials commonly used in injection molding processes. In
some examples, the method comprises disposing material into the
mold and extruding material from the mold to provide the removable
oral device. In certain examples, the method comprises placing a
gasket in the mold prior to providing the removable oral device,
wherein the gasket is present between the body of the palatal
element and the clasping element. In some examples, the method
comprises three-dimensionally printing the palatal element using a
photo-curable material. In other embodiments, the method comprises
disposing one or more wires on a printer support as the clasping
element and printing the photo-curable material into the printer
support comprising the one or more wires to provide the removable
oral device. In some examples, the method comprises photo-curing
the printed palatal element using UV/Visible light. In further
examples, the method comprises printing each of the palatal element
and the clasping element using a photo-curable material. In some
instances, the method comprises three-dimensionally printing the
removable oral device using an inkjet three-dimensional printer. In
other embodiments, the method comprises three-dimensionally
printing the removable oral device using digital light
processing.
[0098] In another configuration, a method comprises imaging an oral
cavity of a human, printing an impression tray using the imaged
oral cavity, using the printed impression tray and impression
material to obtain an impression of the oral cavity of the human,
and providing a removable oral device using the impression of the
oral cavity. The removable oral device comprises a palatal element
coupled to a clasping element, in which the palatal element is
configured to contact a roof of a user's mouth at a palatal
surface, and wherein the palatal element comprises a body
comprising a thickness configured to lower a vaulted area of the
roof of the mouth to decrease an overall oral volume of the mouth
to a first oral volume. The clasping element, when present, is
configured to assist in removal of the removable oral device from
the mouth and/or to retain the palatal surface of the palatal
element against the roof of the user's mouth when the removable
oral device is inserted into the user's mouth. Conventional
impression trays are generally one size fits all configurations and
may not be suitable for producing the removable oral devices
described herein. For example, the trays may be too large or not
include suitable features to provide good impressions of the
palatal surface of the user. In one example and referring to FIGS.
10A and 10B, an impression tray 1000 can be printed that includes a
front surface 1010 and a back surface 1020 with a channel 1025
running between them in a generally semi-circular pattern which
mirrors the upper teeth. The impression tray also comprises a
raised central portion 1030 to capture the palatal shape of the
user's mouth. The back surface 1020 comprises a stop or wall 1022
to prevent the molding material from pushing backwards into the
user's mouth. This feature reduces the overall posterior side size
of the removable oral device to avoid or deter the gagging reflex.
Similarly, the front surface 1010 may comprise a wall to reduce the
overall thickness of the removable oral device at the front to
minimize or reduce lisping and/or to provide a palatal element
which does not contact rear surfaces of the anterior teeth.
Illustrative impression materials include those commonly used in
dentistry applications, Silident materials, clays,
polyvinylsiloxanes, alginates and other materials which can capture
the shape of the upper mouth including the palate. The printed
impression tray may also comprise the clasping element pre-printed
to account for the space it takes up in the removable oral device.
As shown in FIGS. 10A and 10B, the impression tray may comprise a
plurality of apertures or holes to permit the impression material
to be forced downward to provide a better representation of the
palatal shape.
[0099] In certain examples, the method comprises using an image
head configured to receive a disposable cover to image the oral
cavity. In other embodiments, the method comprises injecting a
material into the impression of the oral cavity to provide the
removable oral device. In some examples, the method comprises using
a gasket with the removable oral device, wherein the gasket is
present between the body of the palatal element and the clasping
element. In some examples, the method comprises three-dimensionally
printing the impression tray using a photo-curable material. In
other examples, the method comprises photo-curing the printed
impression tray using UV/Visible light. In additional examples, the
method comprises scanning the impression to provide a digital image
of the impression. In other examples, the method comprises using
the digital image to print the removable oral device. In some
embodiments, the method comprises three-dimensionally printing the
removable oral device from the digital image using an inkjet
three-dimensional printer. In certain examples, the method
comprises three-dimensionally printing the removable oral device
from the digital image using digital light processing.
[0100] In certain instances, the impression tray can be used to
assist in determining the shape of the clasping element, e.g., the
shape of the supporting wires of the clasping element. In other
examples, the impression tray may be configured with a stop or
other feature at the front to guide shaping of the front portion of
the palatal element in a manner that reduces lisping. For example,
the impression tray may be configured to permit the removal of the
entire front portion of the palatal element so the tongue can
contact the back surfaces of the front teeth in order to reduce
lisping. Similarly, the back portion of the impression tray can be
designed to inhibit rear movement of the impression material so
that a lower amount of material (or no material at all) is present
at the back portion of the palatal element near the back of the
mouth. Lesser amounts of the material, e.g., a reduced thickness,
can reduce the likelihood of gagging when the removable oral device
is in place.
[0101] In another configuration, a method comprises obtaining an
impression of an oral cavity of a human using an impression tray
and impression material, and providing a removable oral device
using the impression of the oral cavity. In some instances, the
removable oral device comprises a palatal element coupled to a
clasping element, in which the palatal element is configured to
contact a roof of a user's mouth at a palatal surface, the palatal
element comprising a body comprising a thickness configured to
lower a vaulted area of the roof of the mouth to decrease an
overall oral volume of the mouth to a first oral volume, wherein
the body comprises a variable hardness across a tongue surface of
the body. The clasping element, when present, is configured to
assist in removal of the removable oral device from the mouth
and/or to retain the palatal surface of the palatal element against
the roof of the user's mouth when the removable oral device is
inserted into the user's mouth.
[0102] In certain examples, the variable hardness may provide
several desirable attributes including, but not limited to, a
better fit, a less obtrusive device, enhanced flexibility, reduced
lisping and/or reduced gagging. In some examples, different
materials are used at the edges of the palatal element to provide
one or more of these desired attributes. In one example, an
impression tray can be filled with a putty-like material, an
alginate or other materials. As noted herein, the impression tray
may include front and back features which permit the palatal
element to be thinner at these areas, e.g., vertical stops or dams
may be present to stop the putty material from entering into these
spaces. While the exact putty material used can vary, vinyl
polysiloxane materials or other suitable materials can be used.
Both one-part and two-part impression materials can be used with
one or more hardeners or other materials as desired. The impression
tray typically comprises one or more bulges, e.g., bulge 1030 in
FIGS. 10A and 10B, to permit palatal impression as well. In
comparison to orthodontic molds, both the teeth and palatal
surfaces are used for the impression. The impression tray may
comprise holes in the bottom surfaces to permit excess material to
be forced downward rather than forward or backward. If desired, the
overall impression can be used in combination with one or more oral
imaging methods to provide a combined image which can be used to
provide a removable oral device. The combination of a digital image
and a physical mold can permit further tuning of the removable oral
device shape and/or size.
[0103] In another configuration, a method comprises imaging an oral
cavity of a human using a first removable oral device comprising a
palatal element coupled to a clasping element. For example, the
palatal element of the first removable oral device comprises a body
comprising an embedded camera configured to capture an image of the
oral cavity. The clasping element of the first removable oral
device is configured to place a palatal surface of the palatal
element of the first removable oral device adjacent to a roof of
the human's mouth when the first removable oral device is inserted
into the human's mouth. Once properly placed, the palatal element
can capture images of the mouth of the user and store them on a
memory unit or other device on-board the removable oral device. The
captured images can then be used to provide a second removable oral
device comprising a palatal element coupled to a clasping element.
The second removable oral device can be customized or tailored for
the exact mouth shape and may include thinner front and rear
sections to reduce lisping and gagging, respectively. The palatal
element of the second removable oral device is configured to
contact a roof of a user's mouth at a palatal surface. The palatal
element of the second removable oral device comprises a body
comprising a thickness configured to lower a vaulted area of the
roof of the mouth to decrease an overall oral volume of the mouth
to a first oral volume. The clasping element, when present, is
configured to assist in removal of the removable oral device from
the mouth and/or to retain the palatal surface of the palatal
element against the roof of the user's mouth when the removable
oral device is inserted into the user's mouth. If desired, the
camera can be replaced with an ultrasound sensor, optical sensor or
other sensors which can sense the distance of the sensor to various
areas of the palate or roof of the mouth. These distance
measurements can be used to provide a digital image of the mouth,
which can be used to provide the removable oral device.
[0104] In certain instances, a method of producing a removable oral
device comprises providing a removable oral device comprising a
palatal element coupled to a clasping element. The palatal element
is configured to contact a roof of a user's mouth at a palatal
surface and comprises a body comprising a thickness configured to
lower a vaulted area of the roof of the mouth to decrease an
overall oral volume of the mouth to a first oral volume. The
palatal element comprises a softer material at edges of the body
than at an apex of the body, e.g., the palatal element may comprise
a variable hardness. The clasping element, when present, is
configured to assist in removal of the removable oral device from
the mouth and/or to retain the palatal surface of the palatal
element against the roof of the user's mouth when the removable
oral device is inserted into the user's mouth. The method also
comprises forming the clasping element by bending the clasping
element and sizing it to contact outer surfaces of at least three
adjacent teeth, e.g., adjacent teeth with tooth numbers 1 to 4 or
12 to 16 or both where two clasping elements are present.
[0105] In certain examples, the method comprises configuring the
body to be thinner at a front surface of the body than at the apex
surface. In some examples, the method comprises configuring the
body to be thinner at a rear surface of the body than at the apex
surface. In other examples, the method comprises configuring the
clasping element as a pair of wires with one wire positioned on
each side of the palatal element. In additional examples, the
method comprises configuring the wires to have a smaller outer
diameter at a terminus of the wires. In some embodiments, the
method comprises configuring the removable oral device to not alter
a position of the user's teeth. In other examples, the method
comprises configuring the removable oral device to not retain a
position of the user's teeth. In some instances, the method
comprises sizing the clasping element to contact outer surfaces of
tooth numbers 1 to 5 or tooth numbers 1 to 3 or tooth numbers 1 to
2 or tooth numbers 2 to 4 or tooth numbers 2 to 3 or tooth numbers
11 to 16 or tooth numbers 13 to 16 or tooth numbers 14 to 16 or
tooth numbers 13 to 15 or tooth numbers 13 to 14.
[0106] In certain embodiments, the methods described herein may use
one or more computer systems and/or common hardware circuity
including, for example, a microprocessor and/or suitable software
for operating the system, e.g., to obtain an image, print some
portion of a removable oral device, etc. In some examples, the
printer may comprise a processor, operating system and other
features to print a removable oral device. Similarly, a scanner
configured to scan the oral cavity may comprise one or more of
these features. The processor can be integral to the systems which
implement the method or may be present on one or more accessory
boards, printed circuit boards or computers electrically coupled to
the components of the methods. The processor can be used, for
example, to receive and/or process images from the mouth, control
printing operations and the like. The processor is typically
electrically coupled to one or more memory units to receive data
from the other components of the system and permit adjustment of
the various system parameters as needed or desired. The processor
may be part of a general-purpose computer such as those based on
Unix, Intel PENTIUM-type processor, Motorola PowerPC, Sun
UltraSPARC, Hewlett-Packard PA-RISC processors, or any other type
of processor. One or more of any type computer system may be used
according to various embodiments of the technology. Further, the
system may be connected to a single computer or may be distributed
among a plurality of computers attached by a communications
network. It should be appreciated that other functions, including
network communication, can be performed and the technology is not
limited to having any particular function or set of functions.
Various aspects of the methods may be implemented as specialized
software executing in a general-purpose computer system. The
computer system may include a processor connected to one or more
memory devices, such as a disk drive, memory, or other device for
storing data. Memory is typically used for storing programs,
calibrations and data during operation of the imaging system,
printing system or other systems which implement the methods.
Components of the computer system may be coupled by an
interconnection device, which may include one or more buses (e.g.,
between components that are integrated within a same machine)
and/or a network (e.g., between components that reside on separate
discrete machines). The interconnection device provides for
communications (e.g., signals, data, instructions) to be exchanged
between components of the system. The computer system typically can
receive and/or issue commands within a processing time, e.g., a few
milliseconds, a few microseconds or less, to permit rapid control
of the devices which implement the methods. For example, computer
control can be implemented to control the rate at which the various
layers of the palatal element are printed. The processor typically
is electrically coupled to a power source which can vary, for
example, be a direct current source, an alternating current source,
a battery, a fuel cell or other power sources or combinations of
power sources. The power source can be shared by the other
components of the system including any wireless probes or devices
used. The system may also include one or more input devices, for
example, a keyboard, mouse, trackball, microphone, touch screen,
manual switch (e.g., override switch) and one or more output
devices, for example, a printing device, display screen, speaker.
In addition, the system may contain one or more communication
interfaces that connect the computer system to a communication
network (in addition or as an alternative to the interconnection
device). The system may also include suitable circuitry to convert
signals received from the various electrical devices present in the
systems. Such circuitry can be present on a printed circuit board
or may be present on a separate board or device that is
electrically coupled to the printed circuit board through a
suitable interface, e.g., a serial ATA interface, ISA interface,
PCI interface or the like or through one or more wireless
interfaces, e.g., Bluetooth, Wi-Fi, Near Field Communication or
other wireless protocols and/or interfaces.
[0107] In certain embodiments, the storage system used in
implementing the methods typically includes a computer readable and
writeable nonvolatile recording medium in which codes can be stored
that can be used by a program to be executed by the processor or
information stored on or in the medium to be processed by the
program. The medium may, for example, be a disk, solid state drive
or flash memory. Typically, in operation, the processor causes data
to be read from the nonvolatile recording medium into another
memory that allows for faster access to the information by the
processor than does the medium. This memory is typically a
volatile, random access memory such as a dynamic random access
memory (DRAM) or static memory (SRAM). It may be located in the
storage system or in the memory system. The processor generally
manipulates the data within the integrated circuit memory and then
copies the data to the medium after processing is completed. For
example, the processor may receive images from a probe and use them
to provide three-dimensional coordinates representative of the
user's oral cavity. A variety of mechanisms are known for managing
data movement between the medium and the integrated circuit memory
element and the technology is not limited thereto. The technology
is also not limited to a particular memory system or storage
system. In certain embodiments, the system may also include
specially-programmed, special-purpose hardware, for example, an
application-specific integrated circuit (ASIC) or a field
programmable gate array (FPGA). Aspects of the technology may be
implemented in software, hardware or firmware, or any combination
thereof. Further, such methods, acts, systems, system elements and
components thereof may be implemented as part of the systems
described above or as an independent component. Although specific
systems are described by way of example as one type of system upon
which various aspects of the technology may be practiced, it should
be appreciated that aspects are not limited to being implemented on
the described system. Various aspects may be practiced on one or
more systems having a different architecture or components. The
system may comprise a general-purpose computer system that is
programmable using a high-level computer programming language. The
systems may be also implemented using specially programmed, special
purpose hardware. In the systems, the processor is typically a
commercially available processor such as the well-known Pentium
class processors available from the Intel Corporation. Many other
processors are available. Such a processor usually executes an
operating system which may be, for example, the Windows 95, Windows
98, Windows NT, Windows 2000 (Windows ME), Windows XP, Windows
Vista, Windows 7, Windows 8 or Windows 10 operating systems
available from the Microsoft Corporation, MAC OS X, e.g., Snow
Leopard, Lion, Mountain Lion or other versions available from
Apple, the Solaris operating system available from Sun
Microsystems, or UNIX or Linux operating systems available from
various sources. Many other operating systems may be used, and in
certain embodiments a simple set of commands or instructions may
function as the operating system.
[0108] In certain examples, the processor and operating system may
together define a platform for which application programs in
high-level programming languages may be written. It should be
understood that the technology is not limited to a particular
system platform, processor, operating system, or network. Also, it
should be apparent to those skilled in the art, given the benefit
of this disclosure, that the present technology is not limited to a
specific programming language or computer system. Further, it
should be appreciated that other appropriate programming languages
and other appropriate systems could also be used. In certain
examples, the hardware or software can be configured to implement
cognitive architecture, neural networks or other suitable
implementations. If desired, one or more portions of the computer
system may be distributed across one or more computer systems
coupled to a communications network. These computer systems also
may be general-purpose computer systems. For example, various
aspects may be distributed among one or more computer systems
configured to provide a service (e.g., servers) to one or more
client computers, or to perform an overall task as part of a
distributed system. For example, various aspects may be performed
on a client-server or multi-tier system that includes components
distributed among one or more server systems that perform various
functions according to various embodiments. These components may be
executable, intermediate (e.g., IL) or interpreted (e.g., Java)
code which communicate over a communication network (e.g., the
Internet) using a communication protocol (e.g., TCP/IP). It should
also be appreciated that the technology is not limited to executing
on any particular system or group of systems. Also, it should be
appreciated that the technology is not limited to any particular
distributed architecture, network, or communication protocol.
[0109] In some instances, various embodiments may be programmed
using an object-oriented programming language, such as, for
example, SQL, SmallTalk, Basic, Java, Javascript, PHP, C++, Ada,
Python, iOS/Swift, Ruby on Rails or C# (C-Sharp). Other
object-oriented programming languages may also be used.
Alternatively, functional, scripting, and/or logical programming
languages may be used. Various configurations may be implemented in
a non-programmed environment (e.g., documents created in HTML, XML
or other format that, when viewed in a window of a browser program,
render aspects of a graphical-user interface (GUI) or perform other
functions). Certain configurations may be implemented as programmed
or non-programmed elements, or any combination thereof. In some
instances, the methods can be implemented through a remote
interface such as those present on a mobile device, tablet, laptop
computer or other portable devices which can communicate through a
wired or wireless interface and permit implementation of the
methods remotely if desired.
[0110] In certain embodiments, the impressions of the palatal area
of a user can be used to build up a palatal element using various
layers of material. For example, a first material comprising an
acrylate can be placed into the mold and built up to a desired
thickness. A second material, typically also comprising an
acrylate, can be placed into the mold at the edges and coupled to
the first material by permitting the various materials to bond to
each other or optionally by using a suitable cross-linking
material. Once coupled to each other, there generally is no
interface between the first material and the second material.
Similar materials (acrylate+cross-linking material) can be used to
build up the material around any clasping elements. As noted
herein, the second material placed at the edges may be selected to
soften at body temperature. Each of the first material and the
second material used with the mold to provide the removable oral
device may independently be selected as an acrylate, a
methacrylate, an acrylic polymer and co-polymer, Silident, a
functionalized bisphenol A methacrylate such as a monofunctional
bisphenol A dimethacrylate or a difunctional bisphenol A
dimethacrylate, a diglycidyl methacrylate ester of bisphenol-A or a
bisphenol-A diglycidyl ether and other materials. In some examples,
the molded palatal element of the removable oral device may
comprise one or more of ethylene glycol dimethacrylate, diethylene
glycol dimethacrylate, triethylene glycol dimethacrylate,
polyethylene glycol dimethacrylate, 2,2 bis[4-(methacryloxy
ethoxy)phenyl]propane, tricyclodecane dimethanol dimethacrylate,
1,10-decanediol dimethacrylate, 1,6-hexanediol dimethacrylate,
1,9-nonanediol dimethacrylate, neopentyl glycol dimethacrylate,
2-hydroxy 1-3 dimethacryloxy propane, trimethylolpropane
trimethacrylate, ethoxylated trimethylol propane trimethacrylate,
ditrimethyolpropane tetramethacrylate, tris (2-hydroxy
ethyl)isocyanurate trimethacrylate, dipentaerythritol
pentamethacrylate, ethoxylated pentaerythritol tetramethacrylate,
propoxylated glyceryl trimethacrylate, propoxylated
trimethylolpropane trimethacrylate, and a polyester dendrimer.
[0111] When introducing elements of the examples disclosed herein,
the articles "a," "an," "the" and "said" are intended to mean that
there are one or more of the elements. The terms "comprising,"
"including" and "having" are intended to be open-ended and mean
that there may be additional elements other than the listed
elements. It will be recognized by the person of ordinary skill in
the art, given the benefit of this disclosure, that various
components of the examples can be interchanged or substituted with
various components in other examples.
[0112] Although certain aspects, examples and embodiments have been
described above, it will be recognized by the person of ordinary
skill in the art, given the benefit of this disclosure, that
additions, substitutions, modifications, and alterations of the
disclosed illustrative aspects, examples and embodiments are
possible.
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