U.S. patent application number 15/651874 was filed with the patent office on 2018-01-25 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 | 20180024530 15/651874 |
Document ID | / |
Family ID | 60988478 |
Filed Date | 2018-01-25 |
United States Patent
Application |
20180024530 |
Kind Code |
A1 |
KIM; Sung ; et al. |
January 25, 2018 |
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.: |
15/651874 |
Filed: |
July 17, 2017 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
62365970 |
Jul 22, 2016 |
|
|
|
Current U.S.
Class: |
128/848 |
Current CPC
Class: |
A61F 5/56 20130101; G05B
19/4097 20130101; A61F 5/566 20130101; A61F 2005/563 20130101; A61C
13/0004 20130101; G16H 50/50 20180101; G05B 2219/35012 20130101;
G05B 2219/35134 20130101; G16H 20/40 20180101; A61C 5/007 20130101;
G05B 2219/49007 20130101; A61C 7/08 20130101; A61C 7/002 20130101;
G05B 2219/45145 20130101 |
International
Class: |
G05B 19/4097 20060101
G05B019/4097; A61F 5/56 20060101 A61F005/56 |
Claims
1. A method of manufacturing a dental device, the method
comprising: obtaining a patient data set from a health care
provider, wherein the patient data set comprises data regarding the
shape of a patient's anatomy; obtaining options from the data set,
the options comprising a set of clinical options for the dental
device from the same or a different health care provider, wherein
the set of clinical options comprises two or more options selected
from the group consisting of splint design, titration mechanisms,
titration accessories, splint design, retention mechanisms, splint
material, fin or strap design, and sleeve, wherein the set of
clinical options are communicating the dentition data set and the
options data set to a computer aided design (CAD) software;
preparing a digital design for the dental device using the CAD
software in accordance with the dentition data set and the options
data set; communicating the digital design to an automated milling
apparatus; and automatedly milling a block of polymer to obtain the
dental device.
2. The method of claim 1, wherein the patient data set comprises
data regarding the shape of a patient's dentition.
3. The method of claim 1, wherein the set of clinical options are
intelligently organized.
4. A method 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 manufacturing apparatus; and
automatedly manufacturing a block of polymer to obtain the dental
device.
5. The method of claim 4, wherein the health care provider is
selected from the group consisting of a dentist, a dental
technician, a physician, a TMJ specialist, and a sleep disorder
specialist.
6. The method of claim 4, wherein the set of clinical options
comprise two or more clinical options selected from the group
consisting of titration mechanisms, titration accessories, splint
design clinical options, retention mechanisms, splint and material
clinical options.
7. The method of claim 6, wherein the titration option is selected
from the group consisting of microtitration series, jack screw
titration, Herbst hinge titration, anterior hinge titration, strap
titration, and mechanical hook.
8. The method of claim 6, wherein the titration accessory is
selected from the group consisting of fin, strap, affixed sleeve,
removable sleeve, straps, anterior hinge, short or long Herbst,
jack screw, and Herbst hinge in combination with jack screw.
9. The method of claim 6, wherein the splint design clinical
options are selected from the group consisting of lingualess, full
lingual coverage, edentulous, posterior lingual, anterior lingual,
anterior lingualess, and monoblock.
10. The method of claim 6, wherein 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.
11. The method of claim 6, 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.
12. The method of claim 6, wherein the fin or straps 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.
13. The method of claim 6, wherein the set of clinical options
further comprise an option selected from the group consisting of an
open anterior, an anterior discluder, a scalloped occlusal and/or
lingual opening, a compliance chip, an AM positioner, a tapered
posterior, a tongue attractor, and a bruxism package.
14. The method of claim 4, wherein the selection of the clinical
options is through a web portal.
15. A dental device manufactured by the method of: obtaining a set
of clinical options from a health care professional; 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 manufacturing
apparatus; and automatedly manufacturing a block of polymer to
obtain the dental device.
16. The method of claim 15, wherein the manufacturing is additive
manufacturing, subtractive manufacturing, or a combination
thereof.
17. A method of treating or ameliorating a jaw-related disorder in
a patient, the method comprising: obtaining a dental device
manufactured by the method of: obtaining a set of clinical options
from a health care professional; 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 manufacturing apparatus; and automatedly
manufacturing a block of polymer to obtain the dental device; 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.
18. The method of claim 17, wherein sleep apnea or the jaw-related
disorder is selected from temporomandibular disorder (TBD), poorly
positioned temporomandibular joint (TMJ), or aesthetic
deficiencies.
19. The method of claim 17, further comprising the step of
instructing the patient in the use of the device.
Description
RELATED APPLICATIONS
[0001] The present application claims priority to the U.S.
Provisional Application Ser. No. 62/365,970 filed by LIPTAK et al.,
and entitled "A COMPUTER AIDED DESIGN MATRIX FOR THE MANUFACTURE OF
ORAL APPLIANCES," the entire disclosure 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.
DETAILED DESCRIPTION OF THE EMBODIMENTS
[0006] 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.
[0007] 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.
[0008] 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.
[0009] 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.
[0010] 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.
[0011] Thus, in one aspect, disclosed herein are methods of
manufacturing a dental device, the method comprising: [0012]
obtaining a set of clinical options from a HCP; [0013] creating a
first data set from the set of clinical options; [0014]
communicating the data set to a computer aided design (CAD)
software; [0015] preparing a digital design for the dental device
using the CAD software; [0016] communicating the digital design to
an automated manufacturing apparatus; and [0017] automatedly
manufacturing the dental device.
[0018] 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.
[0019] 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.
[0020] 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
[0021] 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.
[0022] 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.
[0023] 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.
[0024] 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.
[0025] 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
[0026] 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.
[0027] 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.
[0028] 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.
[0029] 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.
[0030] 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.
[0031] 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.
[0032] 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.
[0033] "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.
[0034] "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.
[0035] "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.
[0036] 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.
[0037] "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.
[0038] "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).
[0039] "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 Nov; 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.
[0040] 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 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.
[0041] 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.
[0042] 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).
[0043] 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 U.S. Provisional Application Ser. No. 62/289,131,
incorporated by reference herein, particularly Paragraphs
[0015]-[0040] and the drawings.
[0044] 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.
[0045] 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.).
[0046] 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.
[0047] 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.
[0048] 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.
[0049] 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.
[0050] 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
[0051] "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.
[0052] 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.
[0053] 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.
[0054] 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.
[0055] 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.
[0056] 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..
[0057] 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.
[0058] 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.
[0059] 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.
[0060] 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.
[0061] 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.
[0062] 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.
[0063] 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.
[0064] 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.
[0065] 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.
[0066] 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
[0067] 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.
[0068] 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).
[0069] 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.
[0070] 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.
[0071] 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.
[0072] 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
[0073] 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.
[0074] 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.
[0075] 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.
[0076] 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.
[0077] In another aspect, disclosed herein is a dental device that
is manufactured by the methods disclosed above.
[0078] 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