U.S. patent application number 15/991991 was filed with the patent office on 2019-01-31 for computer aided design matrix for the manufacture of dental devices.
This patent application is currently assigned to PROSOMNUS SLEEP TECHNOLOGIES, INC.. The applicant listed for this patent is PROSOMNUS SLEEP TECHNOLOGIES, INC.. Invention is credited to Sung KIM, David W. KUHNS, Leonard A. LIPTAK.
Application Number | 20190033826 15/991991 |
Document ID | / |
Family ID | 60988478 |
Filed Date | 2019-01-31 |
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United States Patent
Application |
20190033826 |
Kind Code |
A1 |
KIM; Sung ; et al. |
January 31, 2019 |
COMPUTER AIDED DESIGN MATRIX FOR THE MANUFACTURE OF DENTAL
DEVICES
Abstract
Disclosed herein are methods of manufacturing a dental device,
the method comprising: obtaining a set of clinical options for the
dental device from a health care provider; creating a first data
set from the set of clinical options; communicating the data set to
a computer aided design (CAD) software; preparing a digital design
for the dental device using the CAD software; communicating the
digital design to an automated milling apparatus; and automatedly
milling a block of polymer to obtain the dental device. Also
disclosed are dental devices manufactured by the above method.
Further disclosed are methods of treating or ameliorating apnea
jaw-related disorder in a patient, the method comprising obtaining
a dental device manufactured by the above method and positioning
the dental device over the dentition prior to sleep, whereby the
mandible is advanced forward relative to the maxilla, thereby
ameliorating the symptoms of sleep apnea or the jaw-related
disorder.
Inventors: |
KIM; Sung; (Pleasanton,
CA) ; KUHNS; David W.; (Pleasanton, CA) ;
LIPTAK; Leonard A.; (Pleasanton, CA) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
PROSOMNUS SLEEP TECHNOLOGIES, INC. |
Pleasanton |
CA |
US |
|
|
Assignee: |
PROSOMNUS SLEEP TECHNOLOGIES,
INC.
Pleasanton
CA
|
Family ID: |
60988478 |
Appl. No.: |
15/991991 |
Filed: |
May 29, 2018 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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15651874 |
Jul 17, 2017 |
|
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15991991 |
|
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62365970 |
Jul 22, 2016 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
G05B 2219/35012
20130101; G05B 2219/35134 20130101; A61F 5/566 20130101; A61C 7/08
20130101; G05B 2219/49007 20130101; G05B 19/4097 20130101; A61C
7/002 20130101; A61C 13/0004 20130101; A61C 5/007 20130101; A61F
2005/563 20130101; A61F 5/56 20130101; G16H 50/50 20180101; G05B
2219/45145 20130101; G16H 20/40 20180101 |
International
Class: |
G05B 19/4097 20060101
G05B019/4097; A61C 13/00 20060101 A61C013/00; A61C 5/00 20060101
A61C005/00; A61C 7/08 20060101 A61C007/08 |
Claims
1. A method of manufacturing a kit, the kit comprising a set of
mandibular advancement devices, the method comprising: a. preparing
a three-dimensional electronic model of the patient's dentition; b.
converting the electronic model to a data set; c. obtaining a set
of clinical options, i.e., a prescription, from a health care
provider (HCP) for the treatment of the patient, d. incorporating
within a computer-aided design (CAD) software the data set and the
set of clinical options; e. automatedly manufacturing a dental
appliance, having the set of clinical options, in accordance with
the appliance data set; wherein: the set of mandibular advancement
devices comprise at least one upper and at least one lower splint;
each upper and each lower splint independently comprises a fin, or
a post for a fin to attach thereto; each upper fin or post is
located at a distance UD from the back of the upper splint, and
each lower fin or post is located at a distance LD from the back of
the lower splint; the distances UD and LD are independently
unchangeable; f. providing a first spacer and a second spacer, each
spacer having a thickness, and each spacer having a contact
surface; wherein: each spacer connects by a locking mechanism to
one of the upper or lower fin, or one of the upper or lower post;
the thickness of the first spacer is different than the thickness
of the second spacer; when added, the spacer affords a rake angle
of between about 20.degree. to about 80.degree., between about
80.degree. to about 100.degree., or between about 100.degree. to
about 160.degree..
2. The device of claim 1, wherein the upper and lower splints are
designed digitally and manufactured according to the digital
design.
3. The device of claim 1, wherein each upper fin comprises a front
surface and each spacer on a lower post comprises a back surface,
wherein when the upper and lower splints are worn by a patient, the
front surface of the upper fin contacts the back surface of the
lower spacer along a contact surface; or
4. The device of claim 1, wherein each spacer on an upper post
comprises a front surface and each lower fin comprises a back
surface, wherein when the upper and lower splints are worn by a
patient, the front surface of the upper post contacts the back
surface of the lower fin along a contact surface.
5. The device of claim 1, wherein the shape of each or spacer is
independently selected from a predesigned digital library.
6. The device of claim 1, wherein the spacer comprises a locking
mechanism.
7. The device of claim 6, wherein the locking mechanism is a
friction lock mechanism or a key-tab mechanism.
8. The device of claim 1, wherein the set of clinical options
comprises two or more clinical options selected from the group
consisting of titration mechanisms, titration accessories, splint
design, retention mechanisms, splint material, and fin or strap
design or sleeve.
9. The device of claim 8, wherein the titration mechanism is
selected from the group consisting of microtitration series, jack
screw titration, Herbst hinge titration, anterior hinge titration,
strap titration, and mechanical hook.
10. The device of claim 8, wherein the splint material option is
selected from the group consisting of standard
polymethylmethacrylate (PMMA), lined PMMA, high-strength
polyetheretherketone (PEEK), polymer produced from polyoxymethylene
and acetal copolymers (Duracetal.RTM.), glycol modified
polyethylene terephthalate (PETg), and a physiologically
compatible, water insoluble, non-maleable polymer.
11. A kit manufactured by the method of claim 1.
12. A kit comprising: a) a set of mandibular advancement devices
comprising at least one upper and at least one lower splint; each
upper and each lower splint independently comprises a fin, or a
post for a fin to attach thereto; each upper fin or post is located
at a distance UD from the back of the upper splint, and each lower
fin or post is located at a distance LD from the back of the lower
splint; the distances UD and LD are independently unchangeable; and
b) at plurality of spacers, each spacer having a thickness, and
each spacer having a contact surface; wherein: each spacer connects
by a locking mechanism to one of the upper or lower fin, or one of
the upper or lower post; the thickness of each spacer is different
than the thickness of any other spacer of the plurality of spacers;
when added, the spacer affords a rake angle of between about
20.degree. to about 80.degree., between about 80.degree. to about
100.degree., or between about 100.degree. to about 160.degree..
Description
RELATED APPLICATIONS
[0001] The present application is a continuation of U.S. patent
application Ser. No. 15/651,874 filed Jul. 17, 2017, by KIM et al.,
and entitled "A COMPUTER AIDED DESIGN MATRIX FOR THE MANUFACTURE OF
ORAL APPLIANCES," which in turn claims priority to the U.S.
Provisional Application Ser. No. 62/365,970 filed Jul. 22, 2016, by
LIPTAK et al., and entitled "A COMPUTER AIDED DESIGN MATRIX FOR THE
MANUFACTURE OF ORAL APPLIANCES," the entire disclosure of both of
which, including any drawings, is incorporated by reference
herein.
FIELD OF THE INVENTION
[0002] The present invention is in the field of dental devices. In
particular, the present invention is in the field of a computer
aided design procedure for preparing a design and manufacturing a
dental device.
BACKGROUND OF THE DISCLOSURE
[0003] The use of dental devices to treat sleep apnea is well-known
in the art. These devices use several different techniques for
moving the mandible forward when the device is worn, in order to
open the patient's airway, particularly during the sleep hours, and
thereby reduce the occurrence of sleep apnea. In addition, health
care providers, patients, and manufacturers have a wide variety of
options in choosing the style of the device, the material with
which the device is made, and accessories used with the device.
These options are generally determined by the patient anatomy,
patient comfort, health care provider bias, and the manufacturing
ease.
[0004] Currently, dental devices are hand-crafted artisanally to
the health care provider's specification. Each laboratory or
medical device manufacturer is capable of manufacturing one type,
or at most, a select few of the options. If different styles of
mandibular advancement devices, or combination of mandibular
advancement devices with other splints utilizing the same patient
data, are desired then the patient or the health care provider must
contact multiple laboratories. Accordingly, currently it is
economically impossible to prepare multiple sets of devices for a
patient. As the result, in many cases the patient is not receiving
the device that is the best fit for their needs.
SUMMARY OF THE INVENTION
[0005] Disclosed herein are methods of manufacturing dental
devices, the method comprising: obtaining a set of clinical options
for the dental devices from a health care provider in the form of a
prescription herein referred to as the "Rx," which includes the
treatment plan for the patient; creating a first data set from the
set of clinical options; communicating the data set to a computer
aided design (CAD) software; preparing a digital design for the
dental devices using the CAD software; communicating the digital
design to an automated milling apparatus; and automatedly milling a
block of polymer to obtain the dental device. Also disclosed are
dental devices manufactured by the above method. Further disclosed
are methods of treating or ameliorating sleep apnea or a
jaw-related disorder in a patient, the method comprising obtaining
a dental device manufactured by the above method and positioning
the dental device over the dentition prior to sleep, whereby the
mandible is advanced forward, vertically, laterally or a
combination of the three, relative to the maxilla, thereby
ameliorating the symptoms of sleep apnea or the jaw-related
disorder.
BRIEF DESCRIPTION OF THE DRAWINGS
[0006] FIG. 1A illustrates a front view of an embodiment of the
disclosed mandibular advancement device as it is worn in the mouth,
whereas FIG. 1B shows a side view of the same embodiment.
[0007] FIG. 2A illustrates an embodiment of the upper splint of the
disclosed mandibular advancement devices where the rake angle is
set in a neutral orientation, and FIG. 2B is an illustration of an
embodiment of the lower splint.
[0008] FIG. 3A illustrates an embodiment of the disclosed
mandibular advancement device where the rake angle is set in a
recline orientation. FIG. 3B illustrates an embodiment of the
disclosed mandibular advancement device where the rake angle is set
in a procline orientation.
[0009] FIG. 4A illustrates an embodiment of the fin design in a
predesigned digital library of fins. FIG. 4B illustrates another
embodiment of the fin design in a predesigned digital library of
fins. FIG. 4C illustrates another embodiment of the fin design in a
predesigned digital library of fins. FIG. 4D illustrates another
embodiment of the fin design in a predesigned digital library of
fins. FIG. 4E illustrates that a fin design from the library is
incorporated into an embodiment of the disclosed mandibular
advancement device.
[0010] FIG. 5 illustrates an embodiment of the disclosed mandibular
advancement device where there exists a gap between the lower fin
and the lower splint.
[0011] FIG. 6 illustrates varying the plane of the splint with
respect to the occlusal plane.
[0012] FIG. 7 shows the occlusal side of a splint with cutouts
designed into the device to accurately place ball clasps.
[0013] FIG. 8A shows a free standing upper splint with the
retention arms, while FIG. 8B shows the graphics of how the upper
splint and the retention arms fit into the mouth of the
patient.
[0014] FIG. 9 shows the mechanism of titration when using multiple
upper splints with one lower splint. Each illustrated upper fin
belongs to a separate upper splint
DETAILED DESCRIPTION OF THE EMBODIMENTS
[0015] The present disclosure is directed to a method of obtaining
information about a patient's dentition and the preferences of the
patient and/or a health care provider in order to manufacture a set
of dental appliances that match the patient's needs. Previously,
embodiments of a particular dental appliance, namely a mandibular
advancement device, have been disclosed. See, for example, the
International Publication WO 2015/103084 (the entirety of this
publication, including all the drawings, is incorporated herein by
reference, in particular the following sections describing the
device and the methodology of titration: Paragraphs [0019]-[0053]
and FIGS. 1A-4E and 7-9). The methods and products disclosed herein
are used in connection with the device described in the
above-incorporated document, or any other device that is currently
on the market, or other novel combinations of devices and
accessories.
[0016] In one embodiment the device creates an offset between the
upper and lower splint by using upper and lower fins as boundary
surfaces to restrict movement while the mouth is closed or
reasonably opened.
[0017] In some embodiments, the devices disclosed herein were
digitally designed and then milled as a single unit. In some of
these embodiments, a computer aided design (CAD) process were used
to design and manufacture the mandibular advancement devices
disclosed herein. A plaster model of the patient's dental
impression was first obtained using well-known techniques in the
art. Then, scans of the plaster models were imported into the CAD
software. In other embodiments, the 3D files of the patient's
impression are imported from other sources, such as a direct scan
of the patient dentition using an Intra Oral Scan (IOS) Device,
e.g., the 3M TruDef.TM. scanner, or a direct scan of the impression
from either an IOS or Cone Beam Computed Tomography (CBCT) device.
In these embodiments, the files enable the design of the mandibular
advancement splint in 3D space in a CAD software such as 3-Matic by
Materialise.TM..
[0018] In other embodiments, the different components of the
disclosed devices, for example the splint, the fins, the retention
arms, etc., are milled or manufactured separately and then attached
together after the manufacturing. This approach allows for the use
of interchangeable parts.
[0019] In one embodiment the digitally designed and milled splints
are reproduced accurately without manual polymer buildup. In some
embodiments, accurate reproduction results in accurate replacement
devices. In other embodiments, it results in reproducible titration
settings. In some embodiments the splints are digitally designed
and milled to provide access to pre-cured polymeric materials, and
wherein the device has minimal residual monomers.
[0020] In one embodiment one or more identifying information, e.g.,
the patient's name, order number, and other relevant tracking
information, are designed into the device. The identifying
information appears on the device through the milling process.
[0021] In one embodiment, the device is designed to comfortably fit
on to a patient's upper and lower arches, maintain a maximum amount
of space for the tongue, and keep the mandible advanced forward per
a doctor's prescription while still allowing the patient to
reasonably open their mouth and move their jaw from left to right
for comfort. This contact serves as a barrier to keep the lower fin
in a position forward of this fin engagement surface.
[0022] The disclosed devices can be made from any material that can
withstand the oral environment for an extended period of time, for
example overnight. Furthermore, the material can be any material
that is capable of being milled to form the devices disclosed
herein. Examples of materials include plastics and other polymers,
whether hard or soft, transparent or opaque. Some suitable polymers
include, but are not limited to, a polyetheretherketone (PEEK),
polystyrene, polyvinyl chloride, rubber, synthetic rubber, or an
acrylate polymer, such as a polymer made up of methyl methacrylate,
methyl acrylate, ethyl acrylate, 2-chloroethyl vinyl ether,
2-ethylhexyl acrylate, hydroxyethyl methacrylate, butyl acrylate,
butyl methacrylate, or trimethylolpropane triacrylate (TMPTA).
[0023] Embodiments of the device are further described with
reference to the accompanying drawings.
[0024] FIG. 1 illustrates an embodiment of the disclosed mandibular
advancement device, 100. FIG. 1a shows a front view of the device
as it is worn in the mouth, whereas FIG. 1b shows a side view of
the same embodiment. The device 100 comprises and upper splint 102
and a lower splint 104. The splint 102 is configured to fit snuggly
onto the upper dentition 106, while the lower splint 104 is
configured to fit snuggly onto the lower dentition 108. Each splint
provides enough retention to keep the device on during normal wear
but allowing the user to pull off the device with minimal effort.
The two splints contact each other along the occlusal plane 110,
i.e., the plane passing through the biting surfaces of the
teeth.
[0025] In one embodiment the thickness of the upper splint 102 and
lower splint 104 is independently varied to create a fixed amount
of jaw opening between the patient's arches.
[0026] The devices 100 disclosed herein are prepared individually
and specially for a particular patient. For this reason, while
preparing the digital design of the disclosed devices, the
idiosyncrasies of the patient's oral and dentition structures are
taken into account. For instance, in some embodiments, the opposing
surfaces of the splint are designed in variance with each other to
accommodate the patient's oral structure to achieve maximum
comfort. The surfaces can be flat or be made to touch at one or
more points. This is true of any other feature of the devices 100.
For example, the height, width and shape of the fins; the rake
angle; the offset position of the fins; the location of retention
arms, if any; the dental impressions; inter alia, are designed
specifically for the particular patient. This feature is easily
enabled with a device that is digitally pre-designed. The currently
available devices are handmade, making it difficult for the artisan
to accurately take into account the specific oral features of a
particular patient.
[0027] Each upper splint 102 comprises at least one upper fin 114,
and preferably two upper fins 114. The fin 114 is located to the
side of the upper splint 102 such that when the splint 102 is worn
by the patient, the fin 114 is near the molars. Each upper fin 114
protrudes downwardly.
[0028] Similarly, each lower splint 104 comprises at least one
lower fin 116, and preferably two lower fins 116. The fin 116 is
located to the side of the lower splint 104 such that when the
splint 104 is worn by the patient, the fin 116 is near the molars.
Each lower fin 116 protrudes upwardly.
[0029] Throughout the present disclosure, the terms "up," "upper,"
or "upward," and "down," "lower," or "downward" refer to the
relative position of the upper jaw and the lower jaw. Thus,
"protruding downwardly" means protruding away from the upper jaw
and towards the lower jaw. Similarly, the words "front" or
"forward" and "back" or "backward" refer to the relative position
of components in the mouth. Thus, "front" means towards the lips,
whereas "back" means towards the throat, when the device is in the
mouth.
[0030] FIG. 2A shows the embodiment of the upper splint that is
shown in FIG. 1 and FIG. 2B shows the embodiment of the lower
splint that is shown in FIG. 1. FIG. 2 depicts the splints by
themselves and without being worn on the teeth.
[0031] The upper fin 114 comprises a front surface 202 and the
lower fin 116 comprises a back surface 204. When the device is worn
in the mouth, the lower fin 116 is located in front of the upper
fin 114. The front surface 202 of the upper fin 114 contacts the
back surface 204 of the lower fin 116. This contact serves as a
barrier to keep the lower fin in a position forward of this fin
engagement surface. That is, the contact prevents the lower jaw
from moving backward relative to the upper jaw. Thus, once the
device is worn, the relative forward position of the upper and
lower jaws becomes fixed. The patient would be able to open and
close their mouth and move the lower jaw from left to right for
comfort. However, the patient would not be able to move the lower
jaw backwards beyond the point of contact of the two surfaces
202,204.
[0032] In one embodiment the device is digitally designed and
milled to provide optimal strength with reduced interference to the
tongue creating a comfortable and durable device. As seen in FIGS.
2A & 2B, the two splints each form an arch with an empty center
206. The empty center 206 provides room for the patient's tongue
when the device is in use. The type of design that allows room for
the tongue is referred to as lingual-less. Thus, some embodiments
of the present device 100 are lingual-less designs.
[0033] The upper fin 114 is located at a distance UD (208) from the
back of the upper splint 102. Similarly, the lower fin 116 is
located at a distance LD (210) from the back of the lower splint
104. Distances 208,210 are also referred to as fin offset. The
relative positioning of the fins determines the degree to which the
lower jaw is protruded forward, i.e., the jaw offset. As discussed
below, in some embodiments, the distances 208 and 210 are
manipulated to provide the best fit for the patient.
[0034] In one embodiment, the upper and lower fins vary in angular
shape at the contact surfaces of each fin to provide the most
anatomically correct position and comfort during the motion of
opening and closing the mouth. The embodiment shown in FIG. 1
comprises vertical contact surfaces. In these embodiments, the
contact surfaces 202 and 204 are perpendicular to the occlusal
plain 110. In this embodiment, the rake angle, i.e., the angle that
surface 202 makes with the occlusal plane 110, is 90.degree. to the
occlusal plane, i.e., a neutral angle. In other embodiments, for
example those shown in FIGS. 3A and 3B, the contact surfaces are at
a non-neutral angle. For example, in the embodiment shown in FIG.
3A, the rake angle is set in a recline orientation. In this
embodiment, the surface 202 angles backward. Conversely, in the
embodiment shown in FIG. 3B, the rake angle is set in a procline
orientation. In this embodiment, the surface 202 angles forward.
The rake angle is configured to drive a directional movement during
the opening and closing of the mouth. The particular angle, i.e.,
whether neutral, incline, or procline, and the angle degree, are
chosen based on clinician prescription and patient comfort.
[0035] In one embodiment, the fins are selected from a predesigned
digital library of fins. FIG. 4 shows additional embodiments of the
fin design. FIGS. 4A-4D show some of the embodiments used in a fin
library. In some embodiments, a designer calls from a library of
fin designs, for example those shown in FIGS. 4A-4D, select one fin
type (for example that shown in FIG. 4C), and place onto the custom
patient splint design, as shown in FIG. 4E.
[0036] In some embodiments, for example that shown in FIG. 5, there
exists a gap 502 between the lower fin 116 and the lower splint
104. While the fin 116 is attached to the splint 104 at the base,
the fin 116 protrudes slightly outwards before protruding upward.
In some embodiments, a corresponding gap exists between the upper
fin 114 and the upper splint 102. The gap 502, if present, is
designed into the device based on the prescription and patient
anatomy and comfort. The gap 502 further allows for the side to
side motion of the lower jaw with respect to the upper jaw.
[0037] When the device is worn by a patient and the patient's mouth
is closed, the bottom surface of the upper splint and the top
surface of the lower splint contact each other along the curve of
the device, i.e., the arch of the mouth. The two surfaces contact
each other along the plane of the splint. In one embodiment the
opposing surfaces of the splint are designed such that the plane of
the splint equals the occlusal plane. In some embodiments the plane
of the splint is at an angle to the occlusal plane. FIG. 6
illustrates the ability to design devices in varying degrees of
angle of the plane 110 of the splint to the occlusal plane 602. In
CAD, the angle of the plane 110 of the splint can be adjusted
within the sagittal plane relative to the patient's anatomical
occlusal plane 602. Moreover, the angle of the plane 110 can be
adjusted within the frontal plane relative to the patient's
occlusal plane 602.
[0038] Both adjustments are useful to the clinician to affect
changes to the relative positioning of the mandible and maxillae.
The path of the movement of the upper and lower arches, for the
opening and closing of the mouth, is affected by the engagement
surface 604, i.e., where the contact surfaces 202 and 204 meet. If
the engagement surface 604 is not properly designed, then the upper
and lower arches open and close along an unnatural arc, causing
pain for the patient. In manufacturing the disclosed devices 100,
the natural arc of the patient's jaw movement is taken into account
in the digital design. The engagement surface 604 is then designed
to fit the natural arc.
[0039] In some embodiments, the device 100 is made of transparent
materials, for example transparent plastic, to allow the clinician
to see the patient's dentition through the device 100 to ensure
good fit. Thus, in some embodiments, the clinician can insert a
generic device 100 into the patient's mouth and mark the various
measurements on the transparent device 100 instead of preparing a
dental impression. In other embodiments, a transparent device 100
is prepared first, and relatively inexpensively, and the fit is
tested before a more expensive and permanent device is
manufactured.
[0040] In some embodiments the fins vary in length. In certain
embodiments, the fins are adjusted to the patient's open mouth
dimensions. In some embodiments, the fins vary in length related to
the opposing fin to optimize the length required to maintain
mandible offset position while considering comfort such that each
fin is the same length or a fraction of the length of the opposing
fin. The sum of the heights of an upper fin 114 and lower fin 116
is the total range of contact along the engagement surface before
the two splints are separated. At the point of separation, the two
splints do not exert pressure on each other and do not provide any
jaw offset. In some embodiments, the upper fin 114 and lower fin
116 are of equal heights. In these embodiments, the total range is
optimized while minimizing the height of either fin. The ratio of
the heights of each fin can also be adjusted for patient comfort or
clinical reasons.
[0041] In some embodiments, the thickness of each fin can be
adjusted to apply more or less pressure against the cheek. The
pressure on the cheek stimulates the body to adjust the muscles in
the mouth area, e.g., the airway muscles, for patient comfort or
clinical reasons.
[0042] In one embodiment the device embeds one or more structural
features that create strength using less material. In some
embodiments the structural feature is made from a single material.
The term "embed" as used herein refers to a single material with
design geometries or purposefully milled slots or other geometries
that enable another material to be added as a support member, in
the same way a rebar can strengthen a concrete block. In some
embodiments the structural feature is made from a combination of
materials, such a metal alloy. In some embodiments the metal or
metal alloy is in the shape of a ball clasp, retention wire, or
treatment wire. In some embodiments the treatment wires comprise of
wires to aid in a clinical result deemed important by the
practicing doctor, such as retention wires, alignment wires, or a
tongue behavior modification wire such as spikes or barbs to affect
tongue thrust.
[0043] A patient inserts the disclosed devices 100 into the
patient's mouth before sleep and removes them after sleep. The
devices should be retained in the mouth snugly enough so that the
device does not fall out while the patient is sleeping. However,
the fit cannot be too snug so that the patient cannot easily remove
the device after waking up. The retention of the device 100 in the
mouth is achieved using a combination of one or more of a variety
of retention devices and gaps in space between the device and
tissue.
[0044] In one embodiment the device is retained onto the teeth of a
patient using patient specific retention arms. In some embodiments,
the retention arms replace or improve the classic use of ball
clasps. In the embodiments where ball clasps are used, space for
their placement can easily be designed into the splint. In one
embodiment, FIG. 7 shows the occlusal side of a splint with cutouts
702 designed into the device to accurately place ball clasps.
[0045] In some embodiments, for example that shown in FIG. 8, the
device 100 comprises retention arms 802, built into either or both
of the upper splint 102 and lower splint 104. The retention arms
802 allow for a more secure placing of the splints into the mouth.
FIG. 8A shows a free standing upper splint 102 with the retention
arms 802, while FIG. 8B shows the graphics of how the upper splint
102 and the retention arms fit into the mouth of the patient. In
some embodiments, the retention arms 802 take on the shape of the
classic ball clasp, while in other embodiments, the retention arms
802 perfectly conform to the patient's anatomy to optimize strength
and surface area for retention while allowing for maximum space for
the tongue.
[0046] In some embodiments, a gap is designed between a particular
device surface and one or more surfaces of a patient's anatomy. A
purpose of the gaps is to allow the device 100 to be installed
easily, stay retained under normal conditions, and be removed
easily as well. In some embodiments, the gap is uniform across the
entire contact region between the device and the patient's tissue.
In other embodiments, the gap is strategically placed with properly
designed spacing to provide easy installation of the device in the
mouth, optimal device retention onto the patient's dentition, or
ease of use of the device. The gap is easily programed into the CAD
digital design. Because the disclosed device can be prepared
quickly and inexpensively, the clinician or the designer can
experiment with a series of different gap placings until the best
fit is obtained.
[0047] It is possible, through a series of steps, called titration,
to choose the device having the most clinically relevant mandibular
advancement setting for the patient. Thus, in another aspect,
disclosed herein methods of selecting a mandibular advancement
device for a patient, the method comprising:
[0048] a) obtaining two or more upper splints of the mandibular
advancement device, wherein each upper splint comprises one or more
upper fins, wherein each upper fin is located at a distance UD from
back of the upper splint, and wherein the distance UD of any of the
two or more upper splints is different than the distance UD of any
other of the two or more upper splints; and [0049] obtaining two or
more lower splints of the mandibular advancement device, wherein
each lower splint comprises one or more lower fins, wherein each
lower fin is located at a distance LD from back of the lower
splint, and wherein the distance LD of any of the two or more lower
splints is different than the distance LD of any other of the two
or more lower splints;
[0050] b) choosing a combination of one upper splint and one lower
splint for the patient;
[0051] c) observing the clinical outcome of the chosen combination
of one upper splint and one lower splint;
[0052] d) choosing a different combination of one upper splint and
one lower splint for the patient if the clinical outcome of step c)
is unacceptable; and
[0053] e) repeating steps b)-d) until an acceptable clinical
outcome is obtained.
[0054] Once a digital scan of the patient's dentition is obtained,
a number of upper and lower splints are milled for the patient.
Each of the upper and lower splints has a different fin offset
setting. The clinician chooses one set of upper and lower splints
for the patient. If the patient's condition is not improved
sufficiently, the clinician then chooses another set of splints.
This process is continued until a set of splints providing the best
clinical outcome is chosen. An advantage of the devices and methods
disclosed herein is that by digitally designing the splints and
automatedly manufacturing them, several splints can be prepared
relatively quickly and inexpensively. Further, the digital design
allows for a precise positioning of the fins. A more effective
mandibular advancement can then be obtained than by using a
hand-milled and hand-cranked device.
[0055] In some embodiments, the titration settings provide for a
flexible positioning of the fins in the mouth in the mesial-distal
direction. In some embodiments, the fit of the device 100 on a
patient is titrated through the use of devices 100 with varying
distances 208 and 210 (see FIG. 2). In certain embodiments, the
device 100 is milled directly from a CAD file such that the
accuracy of the data from the impression of the patient's anatomy,
the fit of the device to that data, and the design of the device
are precisely transferred to the milling machine. This enables very
precise design adjustment in positioning each of the fins in the
splint, i.e., the measurement of the distances 208 and 210, and in
their position relative to each other in a reproducible and
manufacturable way.
[0056] For example, in one embodiment, three different upper
splints 102 were manufactured having increasingly longer distances
208, i.e., longer fin offset. Also, two different lower splints 104
were manufactured having two different distances 210. Thus, pairing
one lower splint 104 with one upper splint 102 provided one jaw
offset, while pairing the same upper splint 102 with a different
lower splint 104 provided another jaw offset, and so on.
[0057] An illustrative example is shown in Table 1. To compile this
table, five different upper splints 102 were prepared having 0.0
mm, 1.0 mm, 2.0 mm, 3.0 mm, and 4.0 mm fin offset (distance 208),
respectively. Also, four different lower splints 104 were prepared
having 0.0 mm, 0.5 mm, 1.0 mm, and 2.0 mm fin offset (distance
210), respectively. The combination of the two different splints
can provide a jaw offset ranging from 0.0 mm to 6.0 mm, as shown in
Table 1, where U-1 to U-5 are the upper splint offsets (shown in
parentheses) and L-A to L-D are the lower splint offsets (shown in
parentheses).
TABLE-US-00001 TABLE 1 U-1 U-2 U-3 U-4 U-5 (0.0 mm) (1.0 mm) (2.0
mm) (3.0 mm) (4.0 mm) L-A 0.0 mm 1.0 mm 2.0 mm 3.0 mm 4.0 mm (0.0
mm) L-B 0.5 mm 1.5 mm 2.5 mm 3.5 mm 4.5 mm (0.5 mm) L-C 1.0 mm 2.0
mm 3.0 mm 4.0 mm 5.0 mm (1.0 mm) L-D 2.0 mm 3.0 mm 4.0 mm 5.0 mm
6.0 mm (2.0 mm)
[0058] Thus, twenty different mandibular advancements can be
obtained with only nine different splints, four lower splints and
five upper splints.
[0059] Depending on the clinician's prescription need, the
clinician chooses any reasonable value for the offset of the upper
fin relative to the lower fin, and as many offsets as the clinician
desires. Since the digital manufacturing process accurately and
precisely reproduces the splints, the combination of splints is
repeatable, regardless of when the clinician orders several splints
or splints with other offset distances.
[0060] Another advantage of the disclosed splint combination is
enabling the creation of the same offset with different
combinations of upper and lower splint positions. For example, as
shown in Table 1, a 3.0 mm offset may be created using three
different combinations of upper and lower fins (L-A/U-4, L-C/U-3,
and L-D/U-2). Varying the combined position of the two fins allow
better alignment of the fins within the mouth for reasons of
patient comfort and clinical requirements.
[0061] FIG. 9 illustrates the titration. Three separate upper
splints 102 are provided, one having an upper fin offset of 1 mm
(114-A), one having an upper fin offset of 2 mm (114-B), and one
having an upper fin offset of 3 mm (114-B) (FIG. 9 shows all three
of these upper splints superimposed on each other for illustration
purposes. In actuality, they are separate splints.) One lower
splint 104, having a lower fin offset of 0.5 mm (116) is also
provided. Not shown is a lower splint 104 having a lower fin offset
of 0 mm. The following combinations of splints provide the
mandibular advancements of Table 2.
TABLE-US-00002 TABLE 2 Upper Lower 1.0 mm 2.0 mm 3.0 mm 0.0 mm 1.0
mm 2.0 mm 3.0 mm 0.5 mm 1.5 mm 2.5 mm 3.5 mm
[0062] In another aspect, disclosed herein are methods of reducing
partial constriction of airway during sleep for a patient, the
method comprising identifying a patient in need thereof; and
administering to the patient the mandibular advancement device as
disclosed herein.
[0063] In another aspect, disclosed herein are methods of
manufacturing a mandibular advancement device, the method
comprising obtaining measurements from a patient's dentition;
digitally designing a mandibular advancement device; and milling
the mandibular advancement device. In some embodiments, the
obtaining measurement step comprises obtaining a dental
impression.
[0064] While the methodology disclosed herein can be practiced
through numerous different, and varied, steps, the steps can be
thought of as falling into at least three separate, yet connected,
stages. First, a health care provider (HCP) examines the patient
and obtains an impression of the patient's dentition, and models
the bite by taking a bite impression in one or more positions of
the mandible relative to maxilla. The relative position of the jaw
bones also includes the position of the condyle in the mandibular
fossa. The impressions can be taken traditionally with dental
impression material and poured up in stone either at the HCP office
or at the manufacturing laboratory or site (MFG). Additionally, the
HCP may digitally capture the patient dentition, bite (for example
relative bite position) and anatomy and send the resulting data set
to the MFG. The HCP may also capture the position of the mandible
relative to the maxilla at several positions such that a range of
motion can be modelled from which an ideal new position for the
mandible, which was not captured in the clinic, can be created in
the CAD software. In some embodiments, the HCP also captures data
regarding the patient's anatomy. These data may include cone beam
computer tomographic (CBCT) images of the temporomandibular joint
(TMJ), facial landmarks, airway anatomy, and the like.
[0065] Then, based on the patient's needs and anatomy, the HCP
selects several clinical options, discussed fully below, for the
particular device of interest for the patient. Second, the HCP
communicates these clinical options to the MFG. The MFG creates a
computer aided design (CAD) of the device, having the selected
clinical options. Third, the design is communicated to an automated
manufacturing machine, which creates the selected device from a
block of an appropriate material. Other machines can then install
other accessories that cannot be manufactured as a single
contiguous unit along with the device. The CAD process may create
several devices from the same data set, each device designed to
serve a different aspect of the treatment plan, such as nighttime
treatment of sleep apnea or bruxing, or daytime treatment for pain
relief or aesthetics, where the device places the mandible in a
different position relative to the maxilla for a specific outcome
related to the treatment plan.
[0066] In some embodiments, the block is made up of a solid
material. In certain embodiments, the block is a polymeric block.
In other embodiments, the block is made of a natural substance, for
example metal, wood, natural resin, natural rubber, and the like.
In other embodiments, the block is made of synthetic polymeric
material, having either one type of monomer or two or more
co-polymers.
[0067] The automated fashion by which the dental devices are
prepared allow for a multitude of different devices, having
different features, to be prepared rapidly and economically, where
the devices are identically manufactured. This allows for the
patient and the HCP to experiment with a number of different option
to see which one fits the patient's mouth and dentition better.
This process cannot be effectively done using the current
technologies because the current dental devices are prepared
artisanally by hand, which introduces variations into the
manufactured devices, even when they are prepared from the same
exact set of requirements.
[0068] Thus, in one aspect, disclosed herein are methods of
manufacturing a dental device, the method comprising: [0069]
obtaining a set of clinical options from a HCP; [0070] creating a
first data set from the set of clinical options; [0071]
communicating the data set to a computer aided design (CAD)
software; [0072] preparing a digital design for the dental device
using the CAD software; [0073] communicating the digital design to
an automated manufacturing apparatus; and [0074] automatedly
manufacturing the dental device.
[0075] In some embodiments, the steps of preparing the digital
design, communicating the design with the manufacturing apparatus,
and manufacturing the device, are repeated for each of the desired
devices. In some of these embodiments, however, the same patient
data set is used to manufacture the multitudes of devices. In some
embodiments, the several devices are used in sequence. For
instance, if the mandibular repositioning is meant to include
repositioning in various directions, one device may be used to
reposition the mandible from a first to a second position, a second
device is used to reposition the mandible from the second to a
third position, and etc.
[0076] In some embodiments, the HCP is a dentist. In other
embodiments, the HCP is a dental technician. In other embodiments,
the HCP is a sleep disorder specialist. In certain embodiments, the
HCP is an individual charged with altering the position of the
patient's mandible (e.g., the use of mandibular advancement
devices). In other embodiments, the HCP is an individual charged
with straightening a patient's teeth (orthodontia) (e.g., the use
of braces and the like. In other embodiments, the HCP is a Temporal
Mandibular Joint (TMJ) and Disease (TMD) specialist who repositions
the mandible to manage pain. In certain embodiments, the patient is
a human.
[0077] In some embodiments, the presently disclosed methods produce
a mandibular advancement device that is worn at night during sleep,
while in other embodiments, additional or singular devices are
designed to be worn during the day. In still other embodiments, the
device can be used 24 hours a day.
Dentition Impression
[0078] Obtaining the data regarding the shape of the patient's
dentition is well-known to those of ordinary skill in the art. In
some embodiments, the HCP obtains the dentition impression using
trays filled with impression materials. The impression is then used
to create a plaster model identical to the patient's dentition.
[0079] In some embodiments, the HCP provides photographs of the
patient's dentition. A computerized three-dimensional (3D) image of
the patient's dentition can then be prepared. In some embodiments,
the patient's dentition is scanned, for example with an intraoral
scanner, while in other embodiments, the plaster model of the
patient's dentition is scanned. The scanning data is used to create
a computerized 3D image of the patient's dentition.
[0080] A clinically obtained data set can be obtained from the
patient's anatomy using techniques such as, but not limited to,
X-ray imaging, dental impressions, intraoral scanning, cone bean
computed tomography (CBCT), palpitations of the area around the
jaws, visual inspection of the dentition, or patient testimony. The
term "anatomy" includes any patient data that refers to hard or
soft tissue, or specific features that describe that tissue, that
may include well known landmarks such as molar cusps, height of
contour, anatomical planes, facial landmarks or descriptive values
such as arch shape, tongue size, or Malampatti score and the
relationship between the hard and soft tissue to appearance or
function. The data set is then used to create a patient specific
prescription that is precisely implemented into the treatment
device via a CAD/CAM platform and/or a matrix-generated
prescription of various option, such as the one disclosed in U.S.
patent application Ser. No. 15/416,715, the entire disclosure of
which, including any drawings, is incorporate by reference
herein.
[0081] In some embodiments, patient testimony includes descriptions
of symptoms related to sleep breathing disorders, such as sleep
apnea, snoring, upper airway resistance syndrome (UARS) or symptoms
related to malpositioning of the mandible affecting the patency of
the airway or discomfort at the temporal mandibular joint (TMJ)
realized as temporal mandibular disorder (TMD). The mandible is
capable of being positioned in the anterior-posterior direction
(AP), being positioned in the vertical dimension (perpendicular to
the occlusal plane), or rotate around an axis contained in the
occlusal plane. Sometimes the comparison to an airplane or a ship
having the three axes of rotation of pitch, yaw, and roll is a
useful analogy.
[0082] In some embodiments, an HCP provides instructions based on
the current position of the patient's mandible and a desired
treatment position. The desired treatment position can be
determined by many methods, including positioning the mandible in
an open and protruded position using a George Gauge, ProGauge,
Airway Metrics or other like gauges. Additionally, there are
methods that use enunciation of numbers such as "sixty six" to
provide a guide for a treatment position. The HCP can also use
airway analysis using CBCT software in the two positions (current
and desired), evaluate the alignment of the condyle in the fossa
for TMJ positioning or use X-ray imaging for anatomical
measurements. For example, the position of the condyles for the
left and right side of the patient could be measured relative to an
established healthy position. In other embodiments, the HCP may
also find an optimal position for the mandible using heart rate
variability, or other systemic body variables. The difference in
the left and right positions relative to the treatment position can
then be documented and written into the prescription creating the
proper protrusion (symmetrical or asymmetrical), vertical
repositioning, and any other angular components of the mandibular
position. The positioning of the mandible may also meet patient
needs concerning the aesthetics of the face and the impact of a new
mandibular position to the look of the face.
Selecting Clinical Options
[0083] The set of clinical options is prepared based on the HCP' s
determination of what is required and/or most effective for the
treatment of the patient. Thus, the set of clinical options is at
times referred to as the "prescription" or "Rx" that the HCP
provides for the treatment of the patient.
[0084] Throughout the present disclosure, the word "option" or the
phrase "clinical option" as it relates to the selectable options
for a dental device, refers to a category of features. For example,
titration option refers to the category of available titration
features. Titration options serve to create the method of
advancement of the mandible relative to the maxilla. Each
particular feature under an option is a "selection." Thus, the HCP
chooses a selection under an option.
[0085] After examining the patient's dentition and oral anatomy,
the HCP obtains information regarding the shape of the patient's
dentition or the range of motion of the patient's jaw. The range of
motion includes, but is not limited to, rotational and
translational movements of the mandible, such as protrusive
movement, vertical movement, lip competency (i.e., the extent a
person can separate their jaws while keeping the lips closed), or
golden proportions (i.e., the aesthetically accepted ratios of
teeth size to facial dimensions and symmetry). Commonly, this is
done by generating an imprint of the dentition on a polymer or
dental impression material. In other embodiments, the data
regarding the shape the dentition is obtained by analyzing
photographs of the dentition, or by a machine reading the contours
of the dentition.
[0086] Next, the HCP selects a series of clinical options for the
dental device. These clinical options relate to the material that
makes up the dental device, the mechanism of titration, and other
physical features of the device. These clinical options are
described in detail below.
[0087] In some embodiments, the selection of the clinical options
is through a web portal. In these embodiments, a website is
provided for the HCP to communicate the clinical options with the
MFG. In some embodiments, the website provides a questionnaire
where the HCP provides a written response to questions relating to
each option. In other embodiments, the clinical options are listed
with a radio button next to each. The HCP chooses the desired
option by clicking on the appropriate radio button. In yet other
embodiments, the HCP selects the desired option from a drop-down
window, listing all the available selections for that particular
option.
[0088] In some embodiments, the selection of options is
intelligently organized. By "intelligent organization" it is meant
that when the HCP makes an initial selection, then only groups of
subsequent options that create a viable device within the initial
selection are enabled. For example, selecting elements of
contradictory, weak or unsafe designs are not allowed. The final
grouping of the selections along with the patient information and
HCP' s approval culminate in the prescription. In certain
embodiments, the intelligent organization of the selection options
include the availability of only those options for a particular
selection that comply with regulatory requirements.
[0089] In some embodiments, the set of clinical options comprise
two or more clinical options selected from the group consisting of
titration mechanisms, titration accessories, splint design,
retention mechanisms, splint material, and fin or strap design or
sleeve (e.g., a covering for a fin). In certain embodiments, the
clinical options include other features not enumerated herein.
[0090] "Titration" is the process of adjusting the relationship
between the mandible and the maxilla for a desire outcome (also
referred to as "calibration"), such as relief of symptoms due to
obstructive sleep apnea (OSA). Currently, examples of the titration
techniques include the threaded screw system on a device, where the
patient or the HCP adjust or turn a small screw, which causes a
portion of the dental device to move to a position dictated by the
HCP (U.S. Pat. No. 6,604,527); or changing of straps of different
lengths (U.S. Pat. No. 5,365,945). A novel method of titration is
disclosed in the above-incorporated International Publication WO
2015/103084. Portions of the disclosure of the publications listed
in this paragraph related to the adjustment mechanism are
incorporated by reference herein.
[0091] "Retention" is the process of fitting a device to the
dentition, such that the device has a tight enough fit to be
efficacious, yet has a loose enough fit to be comfortably worn by
the patient. Retention may also be optimized to minimize the amount
of tooth movement or bite changes caused by wearing a device the
imparts forces on the teeth and relative position of the mandible
and maxilla to each other.
[0092] "Titration mechanism" is a component or property of the
device, that through adjustment, the upper and lower arch splint
relative position can be affected to achieve a patient outcome. For
each mechanism, a number of "titration accessories" is available,
by way of which the titration is carried out. These accessories are
projections or additions attached to a basic splint. In some
embodiments, the titration accessory is selected from the group
consisting of an electronic or microelectronic device, a "smart"
accessory (i.e., an electronic device that obtains data and
communicates the data with another electronic device), affixed
sleeve, removable sleeve, straps, anterior hinge, short or long
Herbst hinge, jack screw, and Herbst hinge in combination with jack
screw, or any other appliance accessory now known or designed in
the future. In some embodiments, the accessory is separately
manufactured from that of the base dental device. In these
embodiments, the accessory itself is attached to the device after
the manufacturing of the device. In other embodiments, the
accessory is part of the unitary design of the device. In these
embodiments, the accessory comes to being at the same time the
device is manufactured. For example, a fin, a strap, a hinge, a
screw, etc., and combinations thereof, are titration
accessories.
[0093] In some embodiments, the titration mechanism is selected
from the group consisting of microtitration series, jack screw
titration, Herbst hinge titration, anterior hinge titration, strap
titration, mechanical hook, and combinations thereof.
[0094] "Microtitration series" refers to the titration procedure
disclosed in the above-incorporated International Publication WO
2015/103084, particularly in Paragraphs [0051]-[0061], which
paragraphs are explicitly incorporated by reference herein. Through
the use of the microtitration mechanism, a number of upper and
lower splints having fins are manufactured for the patient. Each of
the upper and lower splints has a different fin offset setting. The
clinician chooses one set of upper and lower splints for the
patient. If the patient's condition is not improved sufficiently,
the clinician then chooses another set of splints. This process is
continued until a set of splints providing the best clinical
outcome is chosen. In one embodiment, the HCP may start with one
titration mechanism and then switch one or both splints to
incorporate another mechanism. For example, the upper arch could
start with the "Jack Screw" and then be traded out for the
microtitration upper splint, which has a lower profile and is more
comfortable.
[0095] "Jack screw" (also known as "expansion screw") titration
refers to a system of titration where the movable parts of the
dental device are connected by a screw. A nut is provided, whereby
the turning of the nut causes the movable parts to move with
respect to each other so that the parts either come closer together
or are moved further apart. An example of a jack screw titration is
shown in FIGS. 15a and 15b of U.S. Pat. No. 6,604,527 and the
corresponding discussion in the specification thereof (incorporated
by reference herein).
[0096] "Herbst hinge titration" is well-known to the skilled
artisan. The hinge comprises a smaller cylinder that fits within a
larger cylinder. The user can determine the extent to which the
smaller cylinder can extend out of the larger cylinder, thereby
limiting the extent of separation of the two cylinders. When one
cylinder is attached to, for example, an upper splint of an
advancement device and the other cylinder is attached to the lower
splint, then the two pieces can be separated by a prescribed
distance. By lowering the distance, the user can titrate the
device. A discussion of the Herbst device is found, for example, in
Vela-Hernandez et al., J Clin Orthod. 2004 November; 38(11):590-9
("Clinical management of the Herbst Occlusal Hinge appliance"). A
Herbst hinge titration may also include a set of fixed bars that
are swapped out for different protrusion levels.
[0097] In some embodiments, the titration mechanism is a hybrid
mechanism. In these embodiments, two or more of the above
mechanism, or in combination with other mechanism used in the art,
are combined. An example of a hybrid titration mechanism would be
the combination of microtitration series with expansion screw. An
example of this type of a combination device is disclosed in the
International Publication No. WO 2017/132638 (with a specification
substantially equivalent to that of U.S. Provisional Application
Ser. No. 62/533,420, incorporated by reference herein in its
entirety, including the drawings. For instance, the fin location of
one of the splints, e.g., upper or lower, is changed by replacing
the splint, as in the microtitration series, while the fin location
of the other of the splints is changed by the use of a screw.
[0098] In some embodiments, once the HCP has determined the
titration methodology, the HCP can then pick the desired titration
accessory to affect the chosen methodology. In some embodiments,
the titration accessory is selected from the group consisting of
affixed sleeve, removable sleeve, straps, anterior hinge, short or
long Herbst hinge, jack screw, Herbst hinge in combination with
jack screw, and combinations thereof.
[0099] An "affixed sleeve" is a protrusion immovably attached to
the dental device. The location of the protrusion on the splint,
and more specifically the relative positions of the sleeves on the
upper and lower splints of the dental device, are fixed. An example
of the affixed sleeve embodiment is found, for example, in FIGS. 7
and 6 of U.S. Pat. No. 6,604,527 and the corresponding discussion
in the specification thereof (incorporated by reference
herein).
[0100] A "removable sleeve" is a covering that fits over an affixed
fin on a splint of a dental device, thereby changing the thickness
of the fin. Consequently, the relative positions of the upper and
lower fins are changed and the two splints of the device are
located at a different distance from each other than without the
sleeve. A number of sleeves having different thicknesses can be
prepared for each fin. An embodiment of the removable sleeve is
disclosed in the International Publication No. WO 2017/132638 (with
a specification substantially equivalent to that of the U.S.
Provisional Application Ser. No. 62/289,131, incorporated by
reference herein, particularly Paragraphs [0015]-[0040] and the
drawings.
[0101] In one aspect provided herein is a digitally designed and
milled mandibular advancement device comprising an upper splint and
a lower splint, wherein the upper and lower splints independently
further comprise one or more fins. Also disclosed, to be used with
the device, are a plurality of sleeves, each pair of sleeves having
a unique thickness and/or rake angle, and where the sleeves fit
over the fins.
[0102] Thus, disclosed herein are sleeves for use with a fin of a
mandibular advancement device, the sleeve comprising: [0103] a
shell, having a wall defining a hollow interior, [0104] wherein the
wall encloses the hollow interior on all sides except one, leaving
an opening at one end of the body; [0105] the wall has a thickness
in the range of from about 1 nm to about 5 mm; [0106] the hollow
interior comprises approximately the same size and dimensions as
the fin of the mandibular advancement device.
[0107] In some embodiments, the sleeved fins on the splints provide
accurate increments of advancement of the lower jaw for titration
of the mandible. The terms "dental splint" and "splint" as used
herein refers to several types of orthodontic devices that are
designed to address dental problems such as loose teeth and
bruxism, in addition to problems with snoring and apnea. More
specifically, the term "splint" refers to an upper or lower splint,
having sleeveless fins, which splint is uniquely designed to fit
over a patient's dentition. Thus, as is disclosed further below,
the present disclosure distinguishes between a "sleeveless-fin
splint," which is a splint that fits over the patient's dentition
but the upper and lower fins do not make sufficient contact to
provide the desirable extent of mandibular advancement, and
"sleeved-fin splint," where presently disclosed sleeves have been
placed over the upper and lower fins of the splints, where the
increased thickness afforded by the sleeves causes mandibular
advancement when the splints are worn by the patient.
[0108] A patient in need of the disclosed mandibular advancement
devices wears the upper splint on the upper dentition and the lower
splint on the lower dentition during sleep. The splints are
designed to remain attached to the dentition until the patient
removes them. The sleeved fins of the upper and lower splints cause
a precise placement of the mandible in relation to the maxilla. The
mandible is caused to stay in a forward position and does not relax
and fall back. The airway constriction during the sleep is thereby
minimized.
[0109] In one embodiment the device creates an offset between the
upper and lower splints by using upper and lower sleeved fins as
boundary surfaces to restrict movement while the mouth is closed or
reasonably opened, e.g., opened to the same extent that the mouth
opens during sleep.
[0110] In some embodiments, the splints with sleeveless fins,
disclosed herein were digitally designed and then milled as a
single unit. In some of these embodiments, a computer aided design
(CAD) process were used to design and manufacture the mandibular
advancement devices disclosed herein. Plaster models of the
patient's upper and lower dental impressions were first obtained
using well-known techniques in the art. Then, scans of the plaster
models were imported into the CAD software. In other embodiments,
the 3D files of the patient's impression are imported from other
sources, such as a direct scan of the patient dentition using an
Intra Oral Scan (IOS) Device, e.g., the 3M TruDef.TM. scanner, or a
direct scan of the impression from either an IOS or Cone Beam
Computed Tomography (CBCT) device. In these embodiments, the files
enable the design of the mandibular advancement splint in 3D space
in a CAD software such as 3-Matic by Materialise.TM..
[0111] In other embodiments, the different components of the
disclosed devices, for example the splint, the fins, the fin
sleeves, the retention arms, etc., are milled or manufactured
separately and then attached together after the manufacturing. This
approach allows for the use of interchangeable parts. The design
and manufacturing processes are described in the co-pending U.S.
application Ser. No. 15/416,715, the entire disclosure of which,
including the drawings, and especially Paragraphs [0012]-[0053],
inclusive, are hereby incorporated by reference.
[0112] In some embodiments, a unique single set of upper and lower
splints with sleeveless fins are prepared for each patient. The
patient is then provided with a library of sleeves that fit over
the fins. By changing the sleeves, the patient or the healthcare
provider can change the extent of mandibular advancement. This
approach to the manufacture and use of mandibular advancement
devices provides for a less costly, easier to use, and easier to
manufacture approach to mandibular advancement.
[0113] In one embodiment, the splint is designed to comfortably fit
on to a patient's upper and lower arches, and maintain a maximum
amount of space for the tongue. The sleeved fin keeps the mandible
advanced forward per a doctor's prescription while still allowing
the patient to reasonably open their mouth and move their jaw from
left to right for comfort. This contact serves as a barrier to keep
the lower sleeved fin in a position forward of this fin engagement
surface.
[0114] The disclosed devices can be made from any material that can
withstand the oral environment for an extended period of time, for
example overnight. Furthermore, the material can be any material
that is capable of being milled to form the devices disclosed
herein. Examples of materials include plastics and other polymers,
whether hard or soft, transparent or opaque. Some suitable polymers
include, but are not limited to, a polyetheretherketone (PEEK),
polystyrene, polyvinyl chloride, rubber, synthetic rubber, or an
acrylate polymer, such as a polymer made up of methyl methacrylate,
methyl acrylate, ethyl acrylate, 2-chloroethyl vinyl ether,
2-ethylhexyl acrylate, hydroxyethyl methacrylate, butyl acrylate,
butyl methacrylate, or trimethylolpropane triacrylate (TMPTA).
[0115] In some embodiments, a lower splint is provided with
sleeveless fins. In some embodiments, both the upper and lower
splints comprise sleeveless fins configured to receive a sleeve. In
other embodiments, one of the upper or lower splint comprises
sleeveless fins configured to receive a sleeve, while the other of
the upper or lower splint is configured to make contact with the
sleeved fin of the other splint. That is, the fin thickness and/or
rake angle of one splint can be varied while the fin thickness
and/or rake angle of the other splint is kept constant. While the
disclosure here is in the context of the fins on a lower splint,
the skilled artisan recognizes that both the upper and the lower
splints, or either of the upper or lower splints, can be made to
exhibit the use of the sleeves disclosed herein.
[0116] In an embodiment of the lower splint, the right fin is a
sleeveless fin that is configured to receive a fin. The left fin is
a sleeved fin, where a sleeve has been placed over the fin. The
sleeve increases the thickness of the fin and can provide a rake
angle that is different than that of the fin, or that of other
sleeves. In some embodiments, the rake angle is 90.degree., while
in other embodiments, the rake angle is between about 20.degree. to
about 80.degree., for example, an angle selected from the group
consisting of about 20.degree., about 25.degree., about 30.degree.,
about 35.degree., about 40.degree., about 45.degree., about
50.degree., about 55.degree., about 60.degree., about 65.degree.,
about 70.degree., about 75.degree., and about 80.degree.. In other
embodiments, the rake angle is between about 100.degree. to about
160.degree., for example, an angle selected from the group
consisting of about 100.degree., about 105.degree., about
110.degree., about 115.degree., about 120.degree., about
125.degree., about 130.degree., about 135.degree., about
140.degree., about 145.degree., about 150.degree., about
155.degree., and about 160.degree..
[0117] By "about" a certain value it is meant that the stated value
comprises the range of values within .+-.25%, .+-.20%, .+-.10%, or
.+-.5% of the stated value. Thus, by way of example only, if a
distance is given as "about 5 mm," the range of distances between
3.75 mm (5-25%) to 6.25 mm (5+25%) is envisioned.
[0118] In some embodiments, each sleeve comprises an outer shell,
which defines a hollow interior. Thus, the sleeve has an open end,
where the hollow interior is accessed, and a closed end opposite
the open end. The dimensions of the hollow interior are such that
the sleeveless fin fits inside the hollow interior. When worn over
the fin, the open end of the sleeve abuts the splint, whereas the
closed end is distal to the splint.
[0119] In some embodiments, the fit between the sleeve and the fin
is such that when the sleeve is placed over the fin, the sleeve is
substantially immobile with respect to the fin. By "substantially
immobile" it is meant that the movement of the sleeve with respect
to the fin is not perceptible by the naked eye (that is to say, the
sleeve does not "rattle" when it is placed over the fin).
[0120] In some embodiments, the closed end of the sleeve is curved
away from the plane normal to the plane defined by the rim of the
open end. In certain embodiments, the curvature of the sleeve
approximates the curvature of the patient's mouth, whereas in other
embodiments, the curvature approximates that found in the mouth of
an average patient. The curvature prevents the closed end of the
sleeve to bore into, or unduly rub against the inside of the
patient's cheeks and allows for greater comfort for the patient
when the device is worn.
[0121] The sleeve, and the corresponding sleeve for the upper
sleeve, can each have one of a multitude of designs and shapes. In
one embodiment, the sleeves are selected from a predesigned digital
library of sleeves. In some embodiments, a designer calls from a
library of sleeve designs and selects one sleeve type. The design
is selected based on the patient's need and the geometry of the
patient's dentition and mouth. A set of sleeves are then prepared
having the desired sleeve design. The sleeve is then placed on the
fin of the customized patient splint design.
[0122] The outer shell of the sleeve has a thickness. In some
embodiments, the thickness is uniform throughout the perimeter of
sleeve. In other embodiments, the thickness varies from location to
location in order to enhance the strength of the sleeve. In certain
embodiments, at least the thickness along the contact surface of
sleeve with sleeve varies from one sleeve to another in a set of
multiple sleeves prepared for the same patient. Thus, by varying
the thickness of either or both of sleeves, the extent of
mandibular advancement is varied.
[0123] In some embodiments, the thickness can be varied, either
within a sleeve or from one sleeve to another, for example, from a
1 nm to 5 mm, or from 1 .mu.m to 5 mm, or from 1 mm to 5 mm. In
some embodiments, the thickness is no more than 4 mm, 3 mm, 2 mm,
or 1 mm.
[0124] Various locking mechanisms are contemplated to secure the
sleeve over the fin. In some embodiments, the sleeve is held in
place over the fin by a friction lock mechanism. In these
embodiments, the tight fit of the sleeve over the fin creates
enough friction that the normal use of the device does not dislodge
the sleeve from over the fin. In some of these embodiments,
corresponding grooves (not shown) on one or both of the sleeve and
fin increases the friction between the two pieces.
[0125] In other embodiments, the locking mechanism is a key-tab
mechanism. The tab mechanism is incorporated into the design of the
sleeve. The tab mechanism is separated from the sleeve shell by a
gap. The thickness of the gap can be varied, for example, from a 1
nm to 5 mm, or from 1 .mu.m to 5 mm, or from 1 mm to 5 mm. The tab
has a length, which is less than the full length of the sleeve. The
length can be varied depending on the thickness of the shell, or
the hardness of the material making up the sleeve, and in some
instances depending on the dexterity of the patient, to provide for
a convenient release operation, as discussed below.
[0126] At one end of the tab, either the end close to the open end
or the end close to the closed end of the sleeve, the tab is
connected to the sleeve shell by a living hinge. In some
embodiments, the living hinge is proximal to the open end of the
sleeve. In some embodiments, the tab comprises a key at the
opposite end of the tab from the living hinge. Along the length,
and between the living hinge and the key, a fulcrum is located. The
position of the fulcrum can be varied to provide the most
convenient release operation for the patient.
[0127] In some embodiments, the fin comprises a notch. When the
sleeve is placed over the fin, the key fits into the notch, thereby
holding the sleeve in place. To release the sleeve, the user pushes
on the tab at a location between the fulcrum and the living hinge.
When the tab is pressed, the key moves in the opposite direction
and the key is released from the notch, allowing the sleeve to be
removed.
[0128] In some embodiments, the tab is located on the lingual side
of the sleeve (i.e., the side facing the mouth cavity, or the
tongue), whereas in other embodiments, the tab is located on the
buccal side of the sleeve (i.e., the side facing the inside of the
patient's cheek). In some embodiments, the sleeve comprises at
least two tabs, one on the lingual side and one on the buccal side.
In other embodiments, the tab (or tabs, if there are more than one
tab) are located on the surfaces orthogonal to the lingual and
buccal surfaces. In certain embodiments, the tab is located on the
surface opposite the contact surface. The presence of more than one
tab provides additional locking strength.
[0129] In another embodiment of a locking mechanism, the fin on the
splint comprises a key button, such as a raised boss. The sleeve
comprises a key threshold, which culminates in a key hole. The
shape of the key hole matches the approximate contours and size of
the key button. In these embodiments, the shape of the key button
and the key hole is approximately circular. The key threshold opens
at the open end of the sleeve. The threshold provides a friction
lock for the key button such that once the sleeve is placed over
the fin and the key button is placed inside the key hole, the
sleeve does not fall out of place without the user intentionally
removing the sleeve.
[0130] As discussed above, in the '208 application, the rake angle
can be modified to be in either neutral, procline, or recline
orientation. In some embodiments, the fin is in a neutral
orientation and the rake angle is changed by changing the sleeve.
In these embodiments, only the sleeve affords a change in the rake
angle. In other embodiments, both the fin and the sleeve are
oriented in the desired rake angle orientation.
[0131] In one aspect, provided herein are nesting sleeves. In some
embodiments, different sleeves have different sized hollow
interior, such as one sleeve can fit over another sleeve. To
titrate the patient, first the smallest of the selected sleeves (a
"first sleeve") is put over the fin and the device is tested. if
there is a desire to increase the extent of mandibular advancement,
then another sleeve, with a larger hollow interior (a "second
sleeve"), is placed over the first sleeve, thereby increasing the
overall thickness covering the fin. The next sleeve in the set (a
"third sleeve") can fit over the second sleeve and increase the
thickness yet again.
[0132] In some of these embodiments, the thickness of the different
sleeves is the same, whereas in other embodiments, the thickness of
one sleeve is different than the thickness of another sleeve. In
certain embodiments, the thickness of the second and subsequent
sleeves on the buccal and lingual sides is kept relatively thin,
i.e., 75%, 50%, 40%, 25%, or 10%, of the thickness of the sleeve on
the contact surface side. By varying the thickness in this manner,
the sleeve bulk in the patient's mouth is kept to a minimum while
the mandibular advancement is increased.
[0133] In some embodiments, the sleeves having different thickness
or different sized hollow interior, have different colors. In
certain embodiments, the sleeves are opaque whereas in other
embodiments, the sleeves are transparent. In some embodiments where
the second sleeve fits over the first sleeve, as discussed above,
the sleeves are both transparent and have different colors. In
certain of these embodiments, the colors of the first and second
sleeves combine to form a new color. For example, and without
limitation, in one embodiment the first sleeve is blue and the
second sleeve is red. When the second sleeve is placed over the
first sleeve, then the combined color will be purple. In these
embodiments, the patient or the healthcare provider can quickly
determine the extent of mandibular advancement by looking at the
color of the sleeved fin.
[0134] A "strap" is a rubber or stretchable plastic band that
connects the upper and lower splints of a mandibular advancement
device, thereby providing mandibular advancement while allowing for
a limited motion of the mandible. In some embodiments, the strap is
elastic while in other embodiments, the strap is not elastic. In
some embodiments, the strap is stretchable while in other
embodiments, the strap is not stretchable. An example of a device
using straps is the EMA.RTM. (Elastic Mandibular Advancement) oral
appliance (Glidewell Laboratories, Newport Beach, Calif.). In some
embodiments, the strap is a non-stretchable strap, for example as
used with NARVAL.TM. CC (ResMed, San Diego, Calif.). In some
embodiments, the strap is a link, which is a rigid,
non-stretchable, strap, typically made from a rigid polymer or
metal.
[0135] In some embodiments, the upper and lower splints of a dental
device are connected by a frontal, or anterior, hinge. The relative
openness of the hinge determines the extent of the device's
opening. An example of a device using the anterior hinge is the
TAP.RTM. (Thornton Adjustable Positioner) series of devices (Keller
Lab, Fenton, Mo.).
[0136] While in some embodiments, the HCP chooses the titration
methodology first and then chooses the titration accessory, in
other embodiments, the HCP chooses the titration accessory first,
and then based on the accessory chooses the titration
methodology.
[0137] In some embodiments, the splint design is selected from the
group consisting of a fin, anterior opening, anterior discluder,
scalloped occlusal surface, lingual opening, a tapered posterior, a
tongue attractor, lingualess, full lingual coverage, edentulous,
posterior lingual, anterior lingual, anterior lingualess, and
monoblock.
[0138] The devices worn by a patient comprise a dentition arc that
fits over the patient's dentition. In some devices, the internal
space of the arc is empty. In other words, in these devices the
splint forms the shape of a "U." These devices are termed
"lingualess" devices. (See, for example, SomnoDent.RTM.
(SomnoMed.RTM., Frisco, Tex.) and MicrO.sub.2.RTM. (ProSomnus.RTM.,
Pleasanton, Calif.)). In other devices, the posterior portion of
the splint, i.e., the ends of the "U" that cover the molars, are
connected together to provide additional strength to the device.
The anterior space remains empty. These devices are termed
"anterior lingualess" devices. In some other devices, termed the
"full lingual coverage" design, the splint lacks the empty middle
section.
[0139] A "posterior lingual" or "partially lingual" design is
defined as the design of a dental device that covers the posterior
teeth and provides lingual coverage adjacent to the posterior
teeth. In this design, the device does not cover the lingual or
possibly the labial sides of the front teeth, e.g., the incisors.
In some embodiments, the posterior lingual design has an anterior
portion that fits behind the front teeth. In other embodiments, the
design has no anterior component. The posterior lingual design
exerts a different level of retention than other designs, which may
be of greater comfort for some patients. This design also enables a
structured contoured design, and/or increases the strength of the
device while leaving the space behind the anterior teeth minimally
covered or not covered at all.
[0140] An "anterior lingual" design is defined as the design of a
dental device that provides lingual coverage adjacent to the
anterior teeth. The anterior lingual design exerts a different
level of retention than other designs, which may be of greater
comfort for some patients. This design also enables a structured
contoured design, and/or increases the strength of the device
[0141] "Edentulous" designs are used when the patient lacks a
complete set of teeth. In an edentulous, or full edentulous,
design, the patient has no teeth, and the device is designed for
over the edentulous ridge, or for over the dentures. In a partially
edentulous design, the device is designed to fit in the
adventitious space between the teeth. Additionally, a fully
edentuluous design can incorporate dental implant screws with
buttons that snap into the device for retention.
[0142] In a "monoblock" design, the upper and lower splints are
fused together in one piece. A series of monoblock splints can
create protrusion increments similar to microtitration but with
fused components.
[0143] In some embodiments, the retention mechanism is selected
from the group consisting of implant-retained mechanisms, metallic
ball clasps, plastic ball clasps, dental buttons, soft liner, and a
hard acrylic polymer.
[0144] Several different materials can be used to make splints
using the methods disclosed herein. In general, the splint material
has one or more of the following attributes: the material has
sufficient strength to move the mandible; the material's
malleability and/or compressibility is less than 25% of the desired
adjustment distance; the material does not disintegrate in the
aqueous environment of the mouth; the material does not leave a
repugnant taste in the user's mouth; the material is biocompatible
with the patient's physiology; the material is strong enough to
withstand the pressure exerted by the jaw bones during use; the
material can be additively printed or manufactured and the material
can be machine grinded into the desired shape. Some embodiments of
methods of manufacturing are disclosed in U.S. application Ser. No.
15/416,715, the entire disclosure of which, including the drawings,
and specifically Paragraphs [009]-[0059] of the specification as
originally filed, are incorporated by reference herein.
[0145] In some embodiments, the splint material option is selected
from the group consisting of standard polymethylmethacrylate
(PMMA), lined PMMA, high-strength polyetheretherketone (PEEK),
polymer produced from polyoxymethylene and acetal copolymers
(Duracetal.RTM.), glycol modified polyethylene terephthalate
(PETg), and a physiologically compatible, water insoluble, and
non-maleable polymer. Other polymers meeting one or more of the
general requirements also be used. In certain embodiments, the
splint is made of metal or wood.
[0146] When a splint having fins is used, the anterior surface of
an upper fin, i.e., the mesial surface of a fin on the splint for
the upper jaw, contacts the posterior surface of a lower fin, i.e.,
the distal surface of a fin on the splint for the lower jaw. In
some embodiments, the surfaces make an angle of about 90.degree.
with the patient's occlusal plane, while in other embodiments, the
angle is obtuse, and in still other embodiments, the angle is
acute. In some embodiments, the angle is 90.degree., while in other
embodiments, the angle is between about 20.degree. to about
80.degree., for example, an angle selected from the group
consisting of about 20.degree., about 25.degree., about 30.degree.,
about 35.degree., about 40.degree., about 45.degree., about
50.degree., about 55.degree., about 60.degree., about 65.degree.,
about 70.degree., about 75.degree., and about 80.degree.. In other
embodiments, the angle is between about 100.degree. to about
160.degree., for example, an angle selected from the group
consisting of about 100.degree., about 105.degree., about
110.degree., about 115.degree., about 120.degree., about
125.degree., about 130.degree., about 135.degree., about
140.degree., about 145.degree., about 150.degree., about
155.degree., and about 160.degree..
[0147] Each one of these designs has a set of unique advantages
that the HCP might find beneficial for the patient. The skilled
artisan is familiar with the advantages. Thus, in some embodiments,
the fin or strap design option is selected from the group
consisting of, a normal fin, an acute fin, an obtuse fin, and
straps in compression or traction setting.
[0148] In some embodiments, the set of clinical options further
comprise an option selected from the group consisting of an open
anterior, an anterior discluder, a scalloped occlusal surface, a
lingual opening, a compliance chip, an AM positioner, a tapered
posterior, a tongue attractor, a bruxism package, lingualess, full
lingual coverage, edentulous, posterior lingual, anterior lingual,
anterior lingualess, and monoblock.
[0149] In some embodiments, the HCP chooses a device having an open
anterior. These embodiments, typically direct the HCP to shy away
from choosing an anterior hinge. Anterior discluders, such as the
Best-Bite.TM. discluder (Whip Mix, Louisville, Ky.), are well known
in the art. If the HCP chooses to incorporate an anterior
discluder, it can be modeled into the splint design and
manufactured as a monoblock along with the splint.
[0150] In a device with "scalloped occlusal surface" the occlusal
surface of the splint, for example the molar area, is contoured to
match the occlusal surface of the dentition.
[0151] Devices with a "lingual opening" or "anterior opening" are
devices that have an opening in the anterior portion of the device
that allows for air to move in and out of the mouth even when the
mouth is partially closed.
[0152] Some insurance companies require patient's in certain
professions, for example long haul truck drivers, to show that the
device is being used in compliance with the HCP's instructions.
Some devices comprise an electronic microchip that records the date
and time the device was in use and the date and time the device was
not in use. The data from these "compliance chips" can then be
downloaded and communicated with the insurance company or another
monitoring agency. In some embodiments, where such compliance chip
is required or recommended, HCP chooses to include the chip in the
splint design. The automated manufacturing machine is then
programmed to include a space for the chip. The chip can then be
inserted either automatedly or manually.
[0153] Following the overnight use of a mandibular advancement
device, the joints and muscles of the jaw may experience fatigue,
spasms, and pain because the mandible has been held in a forward,
unnatural position for several hours. An AM positioner, or a
morning positioner, for example Good Morning Positioner (Space
Maintainers Laboratories, Chatsworth, Calif.) will assist to
restore the jaw in the proper position. In some embodiments, the
HCP chooses to provide additional instructions for the design of an
AM positioner, in addition to the instructions for the splint
design, or independent of the splint design, as the same patient
data would be used in the manufacturing of both devices.
[0154] When a foreign device is inserted into the mouth,
subconsciously the mouth continues to explore the new device,
leading to tongue fatigue, which in turn leads to the tongue
falling back in the mouth and further aggravating or producing a
sleep apnea condition. In addition, tongue exploration of the
device can lead to more anterior tongue activity and protrusions.
An attractor can promote this even further to enhance tongue
protrusion and increase muscle tone for a more viable airway. By
strategically positioning a tongue attractor, e.g., a dent, a boss,
a ridged or rough surface, and the like, in the splint, the tongue
seeks the attractor and stays in position over the attractor,
reducing or eliminating tongue fatigue, and/or enhanced tongue
protrusion. In some embodiments, either the lower or upper, or
both, splint has organic shapes as part of the design to increase
the natural feel and comfort of the device, and to also activate
the tongue via proprioceptive pathways, which cause the tongue
and/or the muscle structure surrounding the airway respond to keep
the airway open leading to a reduction in airway related symptoms.
In some embodiments, the tongue attractor is one or more tori
located in the anterior portion of the splint.
[0155] Individuals with bruxism, i.e., night-time teeth grinding,
regularly are prescribed a bruxism package, which comprises a mouth
guard that will protect the teeth during the subconscious grinding.
In some embodiments, where the patient suffers from bruxism in
addition to sleep apnea, the HCP chooses to include a bruxism
package with the splint design. In some embodiments, the bruxism
package is designed from the same set of patient data provided from
the HCP.
[0156] In some embodiments, the selection of certain embodiments of
an option renders the selection of certain embodiments of another
option moot. For example, if the HCP chooses to select
Microtitration Series for the titration mechanism, then the HCP
will not be permitted to choose a Herbst hinge for the titration
accessories. Instead, only accessories associated with the
Microtitration Series, for example fixed or removable fins, will be
available. The "smart" Rx allows only combinations of features such
as the titration mechanism or any other features of the design that
meet the clinical and engineering requirements of making a safe and
useful device. Combinations for the selected features are presented
visually to the HCP for verification of their selection.
Data Handling
[0157] Once all the selections are made on the website, the HCP
communicates the selections with the MFG by any method currently
known in the art, or later developed, for sending data through a
web portal, for example, by clicking on a "SEND" icon at the bottom
of the page, and the like. At this point, the HCP may also transmit
the data regarding the patient's dentition impression to the
laboratory as well. These data may include photographs, scanning
data files, and the like. In some embodiments, the HCP transmits
the two sets of the data (selections and impression)
simultaneously. In other embodiments, the HCP transmits one set of
data prior to the other set of data, for example, by transmitting
each set of data shortly after it is obtained.
[0158] In some embodiments, the data is communicated
electronically. In some of these embodiments, the HCP transmits the
data files by electronic mail. In other embodiments, the HCP
transmits the data files by uploading and transmitting the files
through a website. In some embodiments the data is incorporated
into a 3D PDF, such as that provided by Adobe.RTM.
(https://helpx.adobe.com/acrobat/using/displaying-3d-models-pdfs.html).
[0159] In some embodiments, a first HCP obtains the impression data
and a second, different, HCP prepares the selections. In some
embodiments, the first and the second HCP are coworkers while in
other embodiments, they are not coworkers. In some embodiments, the
same HCP who obtains the impression data is the same individual as
the HCP who prepares the selections.
[0160] As mentioned above, from the dentition impression data a
design of the patient's dentition is obtained, for example using
CAD, by methods well-known in the art. In other embodiments, the
HCP prepares the design and transmits it to the MFG. In other
embodiments, the MFG obtains the raw data from the HCP and prepares
the design in-house.
[0161] In some embodiments, the HCP is in possession of all the
patient data and design specifications used to treat the patient.
The HCP can then draw conclusions and/or trends as to which design
features are best suited for the treatment of which anomalies. In
some embodiments, the data from all the HCPs is aggregated in one
database to obtain a more accurate design-efficacy relationship for
each patient anomaly. This process is sometimes referred to as
"phenotyping," where a single or combination of design
specifications is correlated with the treatment of a single malady.
Whether aggregate data or single-HCP data us used, the result would
be a more efficient treatment plan for future patients.
[0162] Subsequently, the computerized design of a dental device is
prepared, taking into account the HCP' s selections. The CAD file
containing the design is then communicated to an automated
manufacturing machine.
Manufacturing
[0163] The final stage of the process is the manufacture of the
dental device. The CAD file containing the data related to the
manufacture of the dental device is communicated with an automated
manufacturing system.
[0164] In some embodiments, the appliance is manufactured
additively, while in other embodiments, the appliance is
manufactured subtractively. By "additive manufacturing" it is meant
that the future device begins at a nucleus and grows from the
nucleus. Examples of additive manufacturing include 3D printing
(where the device grows out of a pool of monomers), injection
molding (where the mold is filled with the monomer). By
"subtractive manufacturing" it is meant that the future device is
carved out of a block of material. Examples of subtractive
manufacturing include hand carving and milling, e.g., an automated
milling machine.
[0165] In some embodiments, depending on the type of selections
made by the HCP, some clinical options, such as the Herbst lock or
ball clasps, are incorporated into the device subsequent to the
manufacturing step. In some embodiments, these clinical options are
added automatedly by either the manufacturing device or another
machine, while in other embodiments the clinical options are added
manually. In some embodiments the device is the result of assembly
of parts from both additive and subtractive manufacturing. The
fully manufactured device is then provided to the patient either by
the MFG or the HCP.
[0166] In some instances, the HCP may be unsure of what titration
mechanism works best for the patient, or that the patient may
benefit from different types of titration mechanisms as the
treatment progresses. For example, the HCP may require a Herbst
mechanism for the initial stages of the treatment, but would like
to switch to a microtitration or a strap mechanism when the
patient's mandibular position approaches the desired location or
for maintenance therapy. In these embodiments, the splints are
designed and manufactured with an attachment mechanism, such as a
ball-clasp system, friction lock, a nut for a screw-on attachment,
and the like. One example of the attachment mechanism is disclosed
in the U.S. Pat. No. 9,615,964, incorporated by reference herein in
its entirety including the drawings. The splints and the
attachments are then manufactured separately. The HCP can then swap
out the attached mechanism for a different one as the needs of the
patient change.
[0167] In another aspect, disclosed herein is a dental device that
is manufactured by the methods disclosed above.
[0168] In another aspect, disclosed herein is a method of treating
or ameliorating a jaw-related disorder in a patient by obtaining a
dental device manufactured by the methods disclosed above and
positioning the dental device over the dentition prior to sleep.
The device then advances the mandible forward relative to the
maxilla, thereby ameliorating the symptoms of sleep apnea or the
jaw-related disorder. In some embodiments, the method further
comprises instructing the patient in the use of the device. In some
embodiments, the jaw-related disorder is selected from
temporomandibular disorder (TBD), poorly positioned
temporomandibular joint (TMJ), or aesthetic deficiencies.
* * * * *
References