U.S. patent application number 13/772653 was filed with the patent office on 2014-02-27 for method and system for sizing an oral device.
This patent application is currently assigned to ApniCure, Inc.. The applicant listed for this patent is Shannon Clark, Kenneth Mejia, Jonathan L. Podmore. Invention is credited to Shannon Clark, Kenneth Mejia, Jonathan L. Podmore.
Application Number | 20140053850 13/772653 |
Document ID | / |
Family ID | 45563884 |
Filed Date | 2014-02-27 |
United States Patent
Application |
20140053850 |
Kind Code |
A1 |
Podmore; Jonathan L. ; et
al. |
February 27, 2014 |
METHOD AND SYSTEM FOR SIZING AN ORAL DEVICE
Abstract
Systems for sizing oral appliances comprise both a width
measuring template or tool for determining the distance between
opposed molars and an arch sizing tool for determining the size and
shape of the patient's dental arch. Based on this information,
individual appliances can be selected from an inventory of such
appliances, where the selected appliance would best fit the
patient.
Inventors: |
Podmore; Jonathan L.; (San
Carlos, CA) ; Mejia; Kenneth; (San Francisco, CA)
; Clark; Shannon; (Palo Alto, CA) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Podmore; Jonathan L.
Mejia; Kenneth
Clark; Shannon |
San Carlos
San Francisco
Palo Alto |
CA
CA
CA |
US
US
US |
|
|
Assignee: |
ApniCure, Inc.
Redwood City
CA
|
Family ID: |
45563884 |
Appl. No.: |
13/772653 |
Filed: |
February 21, 2013 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
12857375 |
Aug 16, 2010 |
8402973 |
|
|
13772653 |
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Current U.S.
Class: |
128/848 ;
128/861 |
Current CPC
Class: |
A61C 13/12 20130101;
A61M 1/0023 20130101; A61C 9/0006 20130101; A61B 5/0088 20130101;
A61F 5/566 20130101; A61B 5/1076 20130101; A61M 2210/0625
20130101 |
Class at
Publication: |
128/848 ;
128/861 |
International
Class: |
A61F 5/56 20060101
A61F005/56; A61B 5/00 20060101 A61B005/00; A61B 5/107 20060101
A61B005/107; A61M 1/00 20060101 A61M001/00 |
Claims
1. A method for selecting an appropriately sized oral appliance
from an inventory of oral appliances of different sizes, said
method comprising: obtaining an image of a patient's dental arch
showing the positions of individual teeth; determining a width
between opposed teeth on the image; determining an arc geometry
from a plurality of arch geometries which aligns best with the arch
of the dental arch image; and selecting an oral appliance having a
molar width and arch geometry which best match those of the dental
arch on the template which aligned best with the dental arch
image.
2. A method as in claim 1, wherein obtaining the dental arch image
comprises taking a bite wax impression.
3. A method as in claim 1, wherein determining the width comprises
aligning opposed molars on the image with one of a plurality of
width markings on a width sizing template.
4. A method as in claim 1, wherein determining an arc geometry
comprises: aligning an arch sizing template over the image of the
dental arch so that bottom markings are over or adjacent to the
opposed molars; and determining which one of a plurality of arcs on
the template align best with the patient's dental arch image.
5. A method as in claim 4, wherein there are a plurality of arch
sizing templates with one arc template corresponding to each width
marking on the width template, wherein selecting the arc template
comprises selecting the one arch template which corresponds to the
aligned width marking.
6. A method as in claim 4, wherein determining the width comprises
aligning opposed molars on the image with a width marking on each
of the arch sizing templates.
7. A method as in claim 4, wherein the arcs on the arch sizing
template correspond to the front teeth between the canine
teeth.
8. A method as in claim 4, wherein the arcs on the arch sizing
template correspond to the full dentition between the opposed
molars.
9. A method as in claim 1, wherein the oral appliance comprises
structure for drawing a vacuum to treat sleep apnea.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application is a continuation of U.S. patent
application Ser. No. 12/857,375 (Attorney Docket No.
41506-705.201), filed Aug. 16, 2010, the entire content of which is
incorporated herein by reference.
BACKGROUND OF THE INVENTION
[0002] 1. Field of the Invention
[0003] The present invention relates generally to medical devices
and methods. In particular, the present invention relates to a
method and a system for sizing an oral device to allow selection of
a particular device having a proper fit for an individual patient
from an inventory of such devices.
[0004] Mouthpieces, mouth guards, and a variety of other oral
devices are worn by patients for a variety of purposes. Of
particular interest to the present invention, certain oral devices
and appliances can be used for treating obstructive sleep apnea
(OSA) which is a serious medical condition resulting from temporary
airway blockage which occurs as a patient sleeps. A variety of
devices have been developed over the years for altering pressure,
tongue position, and other characteristics of the oral cavity in
order to minimize the occurrence of sleep apnea in patients. One
such oral appliance is described in Published US Application
2009/0120446, assigned to the assignee of the present application,
the full disclosure of which is incorporated herein by
reference.
[0005] Many oral appliances are fitted individually to the patient
being treated, typically by taking a full dental impression,
forming molds from the impression, and preparing devices which
closely conform to the patient's dentition and jaws in order to fit
the patient with great accuracy. While such highly accurate
fittings may in some cases optimize patient comfort, in all cases
they will take time, are inconvenient for the patient, and
significantly increase the cost of the oral device.
[0006] Thus, for a wide class of oral devices, it will be desirable
to provide methods and systems for fitting particular devices from
inventories of pre-manufactured devices having different sizes and
geometry to individual patients. In some cases, such as with
athletic and other mouth guards, the fitting can be rather crude.
As described, for example, in U.S. Pat. No. 5,385,155, in some
instances it is necessary only to provide devices in three sizes
(small, medium, and large) where the devices can be selected using
a single sizing template 40 which can be compared to a dental
impression plate 44 to determine which of the three sizes best fits
the patient.
[0007] For more complex devices, such as those intended to treat
sleep apnea, more accurate sizing means are desirable, and the
ability to rapidly choose from a larger inventory of pre-made
devices will be of great benefit. The present invention provides
such methods and systems which permit treating professionals to
rapidly and accurately choose oral devices from larger inventories
of such devices.
[0008] 2. Description of the Background Art
[0009] U.S. Pat. No. 5,385,155 has been discussed above. U.S.
Patent Publ. No. 2009/0120446 describes oral appliances for
treating OSA of the type which can be usefully sized by the methods
and systems of the present invention.
BRIEF SUMMARY OF THE INVENTION
[0010] The present invention provides methods and systems for
selecting appropriately sized oral devices and appliances from
inventories of such appliances or devices for dispensing to
individual patients. The oral appliances or devices can be
relatively simple mouthpieces or mouth guards which are worn over a
patient's upper and/or lower teeth in order to protect the teeth
during athletic or other endeavors. More usually, the oral devices
or appliances will be intended to provide a therapeutic benefit to
the patient, typically being intended to treat obstructive sleep
apnea (OSA) or other medical conditions. Usually, the inventory of
such devices or appliances will differ principally or entirely by
size and/or geometry. That is, the devices will be identical except
for the dimensions and shape which are intended to fit different
patients having different sized oral cavities and dentition.
Typically, there will be at least five oral appliances or devices
in any inventory, more typically being at least nine such devices,
and frequently being ten, twelve, fifteen, or more such devices.
When there is a large number of devices, size differences between
different devices in the inventory becomes more difficult to
discern and methods for sizing having improved accuracy and
discrimination are advantageous.
[0011] In a first aspect of the present invention, methods are
provided for selecting appropriately sized oral appliances from an
inventory of such appliances, where individual appliances within
the inventory have different sizes and/or geometries selected to
conform to the oral cavities and/or dentition of different
patients. The methods comprise obtaining an image of a patient's
dental arch showing the positions of individual teeth. A width
between opposed teeth, usually opposed molars, on the image is then
measured, and one arch sizing template is selected from a group of
such arch sizing templates based on the measured width. The arch
sizing templates are typically clear or translucent sheets of
material, such as plastics, having a plurality of arcs with
particular shapes, dimensions, and positions printed thereon.
Positions are usually relative to a baseline between the opposed
molars, the dimensions include the distance from the baseline to
the top of the arc as well as the distances between opposed sides
of the arc, and the shape is the geometry of the arc. At a minimum,
the arc shape should reflect the arch of the front six teeth,
between and including the opposed canine teeth, and most often will
reflect an entire dental arch. Typically, each arch sizing template
will display two, three, four, five, six, or more individual arcs,
where the arcs have a common width at their base corresponding to
the measured width between opposed molars on the patient's dental
image.
[0012] After choosing the template having the appropriate molar
width at the base of the printed arcs, the template is aligned over
the image of the patient's dental arch such that markings on the
template at the base of the arch corresponding to the width between
the opposed molars (which indicate the width) are aligned over or
adjacent to the opposed molars shown on the image of the patient's
dental arch.
[0013] After the base of the plurality of arcs is aligned with the
image, a user can visually or otherwise determine which one of the
plurality of arcs on the template align best with the patient's
dental arch image. Usually, each of the plurality of arcs will
comprise a single arcuate line, and the single line can be aligned
above, below, or generally through the individual images of the
patient's teeth on the dental image. Usually, the alignment will be
a visual "best fit," although it would be possible to use more
sophisticated imaging techniques to perform a mathematical "best
fit" of the arc to the dental arch.
[0014] Once the arc on the template having the best fit to the
patient's dental arch is determined, the user can then select the
particular dental appliance from the inventory which corresponds to
the identified arc on the template. The total number of individual
arcs on all of the individual templates will usually correspond to
the total number of individual appliances in the inventory. In that
way, once an arc has been identified on the template, it will
correspond to one and only one appliance in the inventory.
Alternatively, it would be possible to provide a total number of
arcs on the templates which does not correspond exactly to the
number of devices in the inventory. In such cases, it might be
possible to provide a table or other means for identifying which
template arch or arches correspond to any one device in the
inventory. It would also be possible to have two or more devices
correspond to a single arc on a template, which might be useful if
the devices had other characteristics such as material, color, or
differing properties other than size.
[0015] In specific aspects of the methods of the present invention,
the dental arch image may be obtained by taking a bite wax
impression. Alternatively, the image could be obtained using
impression paper, crushable foam, alginate or vinyl polysiloxane
(PVS) impressions, or even digital scanning techniques, although
the latter methods are normally not necessary.
[0016] Measuring the width between opposed molars on the image can
be performed in various ways. Usually, a separate width sizing
template having two, three, four, or more widths marked thereon
will be used. The template, which will be a clear plastic sheet as
with the arch sizing templates, will be placed over the image of
the teeth and right and left hand markers, typically intersecting
lines, will be aligned with opposed molars, typically the opposed
second molars. Alternatively, a simple ruler or scale could be used
to measure the distance between opposed molars, and the measured
distance used to select the arch sizing template for further
sizing. In still other instances, the width measurements could be
made by sequentially aligning the baselines of each of the
individual arch sizing templates, although use of a single width
sizing template is preferred since the closeness of the fits with
each width can be easily compared with each other to choose the
best fit.
[0017] Usually, the methods will employ a plurality of arch sizing
templates with one arch sizing template corresponding to each width
marking on the width sizing template (when the width template is
employed). Thus, the arch sizing template to be used will
correspond to the width measured on the width sizing template. The
arch sizing template is then aligned over the image of the dental
arch with the arc markings aligned, as described previously.
[0018] The methods of the present invention may be used with any
oral appliance having structure intended to be held between a
patient's teeth, e.g., a bite plate of channels which are received
between the teeth on each jaw to hold the device in place. The
methods are preferably used with oral appliances intended to treat
sleep apnea, typically having structure for drawing a vacuum within
the patient's oral cavity.
[0019] The present invention further provides systems for selecting
appropriately sized oral appliances, such as oral appliances and
devices for treating sleep apnea. The systems comprise a bite
imaging plate, a molar width measuring tool, and a plurality of
arch sizing templates. The bite imaging plate is typically a bite
wax plate, but could comprise other media capable of recording the
impression of the teeth when applied to the plate. The width
measuring tool will typically be a width measuring template, as
described above, having a plurality of markings corresponding to
particular distances between opposed molars and suitable for
placement and alignment over the bite imaging plate. The arch
sizing templates will each comprise a plurality of full or partial
arcs corresponding to various sized dental arches, with each arch
sizing template having markings for a single distance between
opposed molars. Thus, after measuring the opposed molars, a
specific arch sizing template can be chosen to be aligned over the
image of the patient's teeth on the bite imaging plate for
determining the size and shape of the dental arch. Once both the
molar width and the size and shape of the dental arch are
determined, a single dental appliance may be selected from an
inventory of such appliances having different sizes and
geometry.
[0020] As described above in connection with the methods of the
present invention, the bite imaging plate is typically a bite wax
plate, the width measuring tool is typically a clear template with
a plurality of width markings, and the arch sizing templates are
typically clear templates each having a plurality of arcs
corresponding to the sizes and shapes of different dental
arches.
BRIEF DESCRIPTION OF THE DRAWINGS
[0021] FIG. 1 illustrates a conventional bite wax plate suitable
for use in the methods and systems of the present invention.
[0022] FIG. 2 illustrates the bite wax plate of FIG. 1 shown after
a patient has transferred a tooth impression to the plate.
[0023] FIG. 3 illustrates a width sizing template useful in the
methods and systems of the present invention.
[0024] FIG. 3A illustrates placement of a corner the medium molar
width template of FIG. 5 over the bite wax plate of FIG. 2.
[0025] FIGS. 4-6 illustrate arch sizing templates suitable for use
in the methods and systems of the present invention, particularly
including templates corresponding to a small molar width, a medium
molar width, and a large molar width, in FIGS. 4-6,
respectively.
[0026] FIG. 7 illustrates an alternative embodiment of the arc
template of FIG. 4, shown with a plurality of arc lines
corresponding to a partial dental arch.
[0027] FIG. 8 illustrates another alternative embodiment to the arc
template of FIG. 4, shown with even shorter arches corresponding to
the front teeth between the canine teeth.
[0028] FIG. 9 illustrates the proper alignment of the width
markings of the template of FIG. 2 with the second molar of the
patient's dentition.
[0029] FIG. 10 illustrates one type of oral appliance useful in the
sizing methods of the present invention.
[0030] FIG. 11 illustrates placement of the oral appliance of FIG.
11 after proper sizing.
[0031] FIG. 12 illustrates placement of the oral appliance in the
patient's oral cavity.
DETAILED DESCRIPTION OF THE INVENTION
[0032] Systems according to the present invention will include a
tool or component for obtaining an image of a patient's dentition,
i.e. all of the teeth in an upper and/or lower jaw, a tool or
component for measuring the distance between opposed molars in the
upper or lower jaw, usually between the second molars but sometimes
between the first molars, and a tool or component for assessing the
size and shape of the dental arch to allow a selection of the most
appropriate dental appliance from an inventory of such appliances
having different sizes.
[0033] tool or component for obtaining an image of the dentition
will typically be a bite wax impression plate 10, as illustrated in
FIG. 1. Such bite wax impression plates are commonly used in the
dental and orthodontic fields and are commercially available from
suppliers, such as Carmel Dental Wax, Inc., Champlain, N.Y. The
bite wax impression plates 10 are used by placing the plate in a
patient's mouth, having the patient bite down with an appropriate
force so that the individual teeth make indentations into the wax
material of the plate. Such impressions leave a very accurate image
of the shape of the teeth in the dental arch, as shown in FIG. 2.
The teeth shown in FIG. 2 are of a patient with wisdom teeth
removed so that second opposed molars 12 lie at the posterior end
of the dental arch with the first opposed molars 14 adjacent
thereto.
[0034] Other tools or components could also be used for obtaining
an image of the patient's dental arch. For example, a sheet or film
of dyed or pressure-sensitive paper could be used in place of the
bite wax impression. The patient would still bite down on the sheet
or film to leave the desired image. Similarly, a crushable foam or
paper could be used to obtain an impression/image of the teeth of
the dental arch. The image could also be obtained optically or by
X-rays. Finally, the present invention could use full alginate
impressions, although a significant advantage of the present
invention is that such full impressions are not necessary.
[0035] Once the image has been obtained, the methods of the present
invention call for determining the distance or width between
opposed molars, either the first or second molars (or possibly the
third molars in the case of patients who have not had their wisdom
teeth removed). Most conveniently, a template 16, as illustrated in
FIG. 3, can be placed over the image as shown in FIG. 2 and the one
of a series of bar-like markings 18S, 18M, and 18L aligned to see
which of the markings best fits. As shown in FIG. 3A, a corner 20
at each end of the marking 18S/L can be aligned with an extension
of the corner position between the first molar 14 and second molar
12 with the end of the marking placed inside of the second molar.
The particular marking 18S/18L which best fits between the teeth
without extending over either of the molars 12 will determine the
width of the dental appliance and allow selection of the arch
sizing template to be used to complete the appliance size selection
process. While three widths as illustrated in FIG. 3 will usually
be sufficient, in some cases it might be desirable to use more.
[0036] Referring now to FIGS. 4-6, a plurality of arch sizing
templates 28S, 28M, and 28L will usually be included in the systems
of the present invention. There will be one arch sizing template
for each of the different widths which may be selected using the
width sizing template 16. Thus, as the width sizing template
includes three different widths, there are three arch sizing
templates, with one template corresponding to each of the widths.
Had there been a different number of widths, there would be a
different but corresponding number of arch sizing templates.
[0037] Each of the arch sizing templates 28S/L will include a base
line 30 having corners 32 which are identically sized to the
markings 18 on the width sizing template 16. Extending upwardly
from the base 30 are a series of differently sized arc lines 34A,
34B, 34C, and 34D (depending on the number of arcs needed to cover
the expected dental arch size range in the patient population).
Each arc line 34 on each template 28S/28L will be given a unique
designation which corresponds to a unique appliance size and/or
designation maintained in the inventory of appliances. As
illustrated, the designations can be a combination of the appliance
width (e.g., S, M, or L) as well as the size of the arch (e.g., A,
B, C, D, etc.). Once the arc has been appropriately aligned, as
described below in connection with FIG. 9, it will then be an easy
matter to select the appropriately sized dental appliance.
[0038] Both the width sizing template 16 and the arch sizing
templates 28 can be formed from any clear or translucent material,
preferably being a clear plastic sheet or film, for example being
formed from a polyester polymer. The markings on the template will
usually be printed thereon, but could also be embossed, etched, or
otherwise formed so that they are clearly visible to the user when
the template is placed over the bite wax impression or other
image.
[0039] Referring now to FIG. 9, the bite wax impression 10 having
the patient's tooth impressions thereon, as illustrated in FIG. 2,
has been measured using the width sizing template 16, and a medium
width arch sizing template 28M selected to determine the patient
arch size. The template 28M is placed over the bite wax impression
10, as illustrated in FIG. 9, with the corners 32 placed over the
second molars 12 adjacent to the first molars 14. At this point,
the user will determine which of the individual arc lines 34 best
aligns with the exterior shape of the patient's dental arch. The
user should determine the closest fit, which in this case would be
arc line MC. With that determination, the user may select the
dental appliance which corresponds to size MC and dispense it to
the patient.
[0040] The individual arc lines on the arch sizing templates 28
need not extend fully from one side of the baseline 30 to the
other. For example, as shown in FIG. 7, the individual arc lines
34' may extend over only an anterior portion, approximately 50% of
the dental arch. Still further alternatively, as shown in FIG. 8,
the individual arc lines 34'' may extend over only the front or
anterior six teeth, i.e., between the canines 40 (as shown in FIG.
2).
[0041] Referring now to FIG. 10, an exemplary dental appliance
which can be sized using the systems and methods of the present
invention comprises an appliance 50 having a base 52 intended for
holding between the patient's teeth in order to position a
tongue-engaging member 54 against the patient's tongue. Base 52 can
be sized using systems and methods described above. Such devices
provide for drawing a vacuum in the oral cavity through the
tongue-engaging member and include a vacuum line 56 extending from
an anterior end thereof. As shown in FIG. 11, once properly sized,
the device can be simply placed in the patient's mouth, and the
patient can close the teeth over the base 52 to hold the device
comfortably in place, as shown in FIG. 12. Such devices are
described in more detail in copending application Ser. No.
12/840,076 (Attorney Docket No. 027094-000200US), the full
disclosure of which is incorporated herein by reference.
[0042] While the above is a complete description of the preferred
embodiments of the invention, various alternatives, modifications,
and equivalents may be used. Therefore, the above description
should not be taken as limiting the scope of the invention which is
defined by the appended claims.
* * * * *