U.S. patent application number 11/773858 was filed with the patent office on 2008-09-18 for systems and methods for correcting malocclusion.
Invention is credited to Michael Kenneth Lowe, William Brent Tarver, Christopher Lyle Wasden.
Application Number | 20080227047 11/773858 |
Document ID | / |
Family ID | 39763064 |
Filed Date | 2008-09-18 |
United States Patent
Application |
20080227047 |
Kind Code |
A1 |
Lowe; Michael Kenneth ; et
al. |
September 18, 2008 |
SYSTEMS AND METHODS FOR CORRECTING MALOCCLUSION
Abstract
Methods of inducing tooth movement and treating malocclusion,
craniofacial anomalies, bony defects, and dentofacial deformities
through accelerated bone remodeling as caused by the delivery
non-static forces; reducing pain and discomfort in patients; and
improving tissue integrity long-term results as to prevent
post-orthodontic treatment relapse. The methods and apparatus
include a mechanism for data capture and analysis related to
patient compliance and usage behavior, as well as for establishing
the invention as a component of the clinical office workflow to
increase efficiency and productivity.
Inventors: |
Lowe; Michael Kenneth;
(Houston, TX) ; Wasden; Christopher Lyle; (Sugar
Land, TX) ; Tarver; William Brent; (Houston,
TX) |
Correspondence
Address: |
TRAN & ASSOCIATES
6768 MEADOW VISTA CT.
SAN JOSE
CA
95135
US
|
Family ID: |
39763064 |
Appl. No.: |
11/773858 |
Filed: |
July 5, 2007 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
60906807 |
Mar 14, 2007 |
|
|
|
Current U.S.
Class: |
433/2 ;
601/46 |
Current CPC
Class: |
A61C 7/008 20130101;
A61C 17/228 20130101; A61C 7/00 20130101; A61C 17/20 20130101; A61C
19/063 20130101; A61C 7/08 20130101; A61C 7/002 20130101 |
Class at
Publication: |
433/2 ;
601/46 |
International
Class: |
A61C 7/00 20060101
A61C007/00 |
Claims
1. An orthodontic appliance, comprising: a. an extraoral vibratory
source; b. an intraoral attachment including at least one of:
archwire, a bracket, a retainer, a palatal expander; and c. an
interface coupling the extraoral vibratory source to the intraoral
attachment.
2. The orthodontic appliance of claim 1, comprising a bite plate
coupled to the extraoral vibratory source.
3. The orthodontic appliance of claim 1, wherein the extraoral
vibratory source comprises a post coupled to the archwire.
4. The orthodontic appliance of claim 3, wherein the post moves
from a resting position to contact the archwire, wherein two
central maxillary incisors come into mesial contact in a patient
maxilla, and two central mandibular incisors come into mesial
contact in a patient mandible.
5. The orthodontic appliance of claim 1, comprising a processor to
control the extraoral vibratory source.
6. The orthodontic appliance of claim 5, wherein the processor
captures usage frequency and duration.
7. The orthodontic appliance of claim 5, wherein the processor
communicates usage frequency and duration to a remote computer.
8. The orthodontic appliance of claim 5, wherein the processor
communicates with the remote computer over the Internet.
9. The orthodontic appliance of claim 1, comprising a rechargeable
battery to drive the vibratory source.
10. The orthodontic appliance of claim 1, wherein the vibratory
source comprises a piezoelectric device.
11. A method for treating occlusion, comprising: a. providing an
extraoral vibratory source; b. mounting an intraoral attachment on
teeth including at least one of: an archwire, a bracket, a
retainer, a palatal expander; and c. interfacing the extraoral
vibratory source to the intraoral attachment.
12. The method of claim 11, comprising coupling a bite plate with
the extraoral vibratory source.
13. The method of claim 11, wherein the extraoral vibratory source
comprises a post coupled to the archwire.
14. The method of claim 13, wherein the post moves from a resting
position to contact the archwire, wherein two central maxillary
incisors come into mesial contact in a patient maxilla, and two
central mandibular incisors come into mesial contact in a patient
mandible.
15. The method of claim 11, comprising digitally controlling the
extraoral vibratory source with a processor.
16. The method of claim 15, wherein the processor captures usage
frequency and duration.
17. The method of claim 15, wherein the processor communicates
usage frequency and duration to a remote computer.
18. The method of claim 11, comprising leasing the extraoral
vibratory source.
19. The method of claim 11, comprising providing diagsnotic
information to a service provider.
20. The method of claim 11, comprising recycling the extraoral
vibratory source.
21. The method of claim 11, comprising treating craniofacial
anomaly, boney defect, or dentofacial deformity.
Description
[0001] This application claims priority from U.S. Provisional
Application Ser. No. 60/906,807, filed on Mar. 14, 2007, the
content of which is incorporated by reference. This application is
also related to commonly owned application entitled "SYSTEMS,
METHODS, AND ADJUNCTIVE PROCEDURES FOR CORRECTING MALOCCLUSION"
having Ser. No. 11/773,849, filed on Jul. 5, 2007, the content of
which is incorporated by reference.
BACKGROUND
[0002] This system relates to systems and methods for treating
malocclusion.
[0003] Orthodontics is a specialty of dentistry that treats
malocclusion through the displacement of teeth and control and
modification of facial growth. This process is accomplished by
using mechanical static forces to induce bone remodeling thereby
enabling teeth to move. This widely accepted approach to treating
malocclusion takes about twenty four months on average. In this
approach, orthodontic braces, consisting of an archwire that
applies a continuous static force to the teeth interfaces with
brackets that are affixed to each tooth, are used to treat a number
of different classifications of clinical malocclusion. These
clinical malocclusions include underbites, overbites, cross bites,
open bites, and crooked teeth, for both esthetic and
functional/structural reasons. Recently, removable clear appliances
such as the Invisalign.RTM. system have been introduced for
treating teeth. The removeable appliances, as well as the
traditional components of the orthodontic system, for example the
tooth brackets and an archwire, are disposable,. At an initial
visit, during a procedure known as bonding, orthodontic brackets
are affixed to the teeth with cement or some similar substance with
adhesive properties. With the exception of incidents of damage or
loss of brackets, the same brackets are maintained throughout the
entire course of treatment. At the end of the treatment, the
orthodontic brackets are removed. Archwires are typically changed
at adjustment visits as necessary. The previous archwire is
disposed of each time a new one is ligated to the brackets. These
direct materials are charged to the patient as a cost element of
the larger treatment fee, which also includes overhead expenses and
direct labor costs. Fixed appliances, such as retainers that must
be worn for some duration post-treatment and clear aligners which
are worn until a pre-determined subsequent visit, are customized in
fit and sold to the patient. Headgear is typically sold to the
patient through the orthodontist and represents a fixed and set
cost that must be paid regardless of treatment duration.
[0004] Orthodontic treatment can be complicated by the fact that it
is oftentimes uncomfortable and painful for patients. Medical
devices have not alleviated the pain associated with this
treatment, including initial bonding, adjustments, and ongoing
discomfort between visits. Post-treatment stability of results and
tissue integrity are also important considerations related to
orthodontic treatment. Stability is typically accomplished and
enhanced through ongoing wear of retainers, in many cases
indefinitely. Compliance issues in wearing retainers can lead to
relapses that require additional treatments.
SUMMARY
[0005] In one aspect, an orthodontic appliance includes an
extraoral vibratory source; an intraoral attachment including at
least one of: archwire, a bracket, a retainer, a palatal expander;
and an interface coupling the extraoral vibratory source to the
intraoral attachment.
[0006] In another aspect, an orthodontic appliance includes an
extraoral or intraoral vibratory source, an intraoral archwire or
bracket and an interface coupling the extraoral vibratory source to
the intraoral archwire or bracket.
[0007] In another aspect, a method for treating occlusion includes
providing an extraoral or intraoral vibratory source; mounting an
intraoral archwire on teeth; and interfacing the extraoral
vibratory source to the intraoral archwire.
[0008] Implementations of the above aspect can include one or more
of the following. A bite plate can be coupled to the extraoral or
intraoral vibratory source. The extraoral or intraoral vibratory
source can have a pillar or post interfacing with the archwire
coupled to the archwire. The pillar moves from a resting position
to contact the archwire at a midline or anywhere with the archwire
or appliance, wherein two central maxillary incisors come into
mesial contact in a patient maxilla, and two central mandibular
incisors come into mesial contact in a patient mandible. The system
can interact with any part of the appliance systems both intra and
extra orally. For example, the interface can contact the teeth at
any point and at one or more points. The interface can contact the
patient at the mid-line of each tooth, or at other locations on the
tooth. A processor can control the extraoral vibratory source. The
processor runs software that captures usage frequency and duration
[and can be programmed to change the force, frequency, wave form,
amplitude, duration or any other operating parameter. The processor
can communicate usage frequency and duration to a remote computer
via any type wired or wireless communication method. The processor
can communicate with the remote computer over the Internet. A
rechargeable battery can drive the vibratory source, wherein the
rechargeable battery is charged using power from any type of power
source including a USB port or an RS-232 port or a FireWire port,
for example. The vibratory source can include a motor or a
piezoelectric device. A leasing, rental or per procedure usage or
any other variable usage systems as well as an out right purchase
system enables the extraoral vibratory source to be provided to
patients a low cost. The system can provide diagnostic information
to a service provider. The system also supports recycling the
extraoral vibratory source.
[0009] In another aspect, a system for treating malocclusion
includes a device that delivers non-static forces to teeth, the
device disposed to teeth, and the device can be leased to a
treating professional.
[0010] In yet another aspect, a system for treating tooth pain
includes a device that delivers non-static forces to one or more
teeth and where the device disposed to the teeth provides pain
relief.
[0011] In yet another aspect, a method for recording the compliant
use of an orthodontic device that delivers non-static forces to
teeth includes a device that delivers non-static forces to teeth,
where the device having electronic media that captures information
pertaining to delivery.
[0012] In a further aspect, a new composition of dental tissue
includes a jaw, the jaw having sustained non-static forces
delivered to the teeth constituents, and the non-static forces
having remodeled the tissues of the mandibular, the periodontal
ligament, or the jaw. [we would like to be able to use our device,
probably would require a separate patent, for other type of
maxiofacial application and trauma like TMJ, Lefort classification
procedures, tooth and other dental implants, etc.]
[0013] In other aspects, inducing tooth movement and treating
malocclusion, craniofacial anomalies, bony defects, and dentofacial
deformities through accelerated bone remodeling are achieved by the
delivery non-static forces; reducing pain and discomfort in
patients; and improving tissue integrity long-term results as to
prevent post-orthodontic treatment relapse. The methods and
apparatus include a mechanism for data capture and analysis related
to patient compliance and usage behavior, as well as for
establishing the invention as a component of the clinical office
workflow to increase efficiency and productivity.
[0014] Advantages of the system may include one or more of the
following. The system enhances the traditional orthodontic
treatment process with the application of non static forces. In
accordance with one embodiment of the system, non-static forces are
used to accelerate the remodeling of craniofacial bones in
conjunction with orthodontic treatment. The system can be used to
treat all forms and classifications of dental malocclusion,
craniofacial anomaly, boney defect, or dentofacial deformity in
which bone remodeling plays a physiological role. The system can be
used exclusively in the maxilla, exclusively in the mandible, or in
a dual-arch manner (both maxilla and mandible at the same time).
Furthermore, the system can be used to treat cases presenting with
a full dentition, any combination of naturally or unnaturally
missing teeth, and to remodel bone in edentulous patients. Patients
of any age and medical history profile can be treated. The system
can be used by patients taking any type of medication.
[0015] The system enables an efficacious, yet quick treatment
period of static force that involves rapidly changing the forces on
the teeth. This is done without requiring the introduction of
piezoelectric currents to the mechanically stressed bone. Patient
compliance is greatly enhanced through computer monitoring of
usage. Treatment outcomes are directly dependent on how closely the
patient follows the instructions of the healthcare professional.
The system can be worn for a predetermined period such as
approximately twenty minutes daily or any other suitable duration
of time, thus the patient can wear the device at home for a modest
wear duration. The healthcare professional can measure patient
compliance and usage patterns that have occurred between
appointments. The measured compliance and application is stored in
electronic means, and available for retrieval by the health care
professional; including retrieval over the internet or any other
communication medium.
[0016] The system supports a business model allows for a
non-disposable component of the orthodontic treatment to be
variable and proportional in cost to the duration of the treatment.
The device can be disposable or non-disposable. The device can be
leased, rented, or purchased on a procedure basis to the patient
directly or through the orthodontist or by a third party. The
proposed system also increases orthodontic case throughput and
therefore office efficiency.
BRIEF DESCRIPTION OF THE DRAWINGS
[0017] FIG. 1 shows one embodiment of an orthodontic treatment
system.
[0018] FIG. 2 shows a second embodiment of an orthodontic treatment
system.
[0019] FIG. 3 shows an exemplary diagram of control electronics
used with the system of FIGS. 1-2.
[0020] FIG. 4 shows an exemplary dental treatment network.
[0021] FIG. 5 shows an exemplary process for treating patients
using the devices of FIG. 1.
[0022] FIG. 6 shows an exemplary process to capture data and
provide data for feedback purposes.
[0023] FIG. 7 shows an exemplary system for leasing, renting or
purchasing the appliances of FIG. 1.
[0024] FIG. 8 shows an exemplary process for improving office and
case efficiency.
[0025] FIGS. 9-10 show an exemplary process to compare differences
in pain level for patients treated with and without the appliances
of FIG. 1.
DESCRIPTION
[0026] Referring now to the drawings in greater detail, there is
illustrated therein structure diagrams for a vibratory dental
appliance and logic flow diagrams for the processes a processor
will utilize to complete treatment and other dental transactions.
It will be understood that the program is run on a computer that is
capable of communication with consumers via a network both wired
and wirelessly, as will be more readily understood from a study of
the diagrams.
[0027] In accordance with one embodiment of the invention,
non-static forces are used to accelerate the remodeling of
craniofacial bones in conjunction with orthodontic treatment. The
system can be used to treat all forms and classifications of dental
malocclusion, craniofacial anomaly, boney defect, or dentofacial
deformity in which bone remodeling plays a physiological role. The
system can be used exclusively in the maxilla, exclusively in the
mandible, or in a dual-arch manner (both maxilla and mandible at
the same time). Furthermore, the system can be used to treat cases
presenting with a full dentition, any combination of naturally or
unnaturally missing teeth, and to remodel bone in edentulous
patients. Patients of any age and medical history profile can be
treated. The system can be used by patients taking any type of
medication.
[0028] FIG. 1 shows one embodiment of an orthodontic treatment
system 10. The system or device 10 has an intraoral bite plate 20
that is inserted into a patient's mouth. The bite plate 10 is
connected to a vibration source 30 which in turn is connected
through an interface 32 to an arch wire 34. The arch wire 34 is
secured to a plurality of brackets that are attached to the
patient's teeth for correcting malocclusion, among others. The bite
plate 10 is clamped down by the patient's jaw 40 to secure the
vibration source 30 to the arch wire 34 and to position the system
in the patient's mouth. The device 10 can interfacing with any part
of the appliance and hardware with all types of hardware such as
lingual brackets, clear brackets, self-ligating brackets, and
removable appliances.
[0029] In one embodiment shown in FIG. 2, the vibration source 30
is positioned in an extraoral housing 33 to hold the components
necessary to generate and apply the force. This embodiment can
generate and apply non-static forces to either the maxillary or
mandibular arch or both. This particular embodiment involves a dual
arch configuration that works with arches 42-44. The patient
inserts the plate 20 into the oral cavity and bites down, holding
the system 10 steady between the teeth, regardless of which of
arches 42-44 the device is being activated for use with. The
vibration source 30 contained in the extraoral compartment 33 is
activated by pushing a button 31 located on the side of the housing
apparatus.
[0030] In one embodiment, the device works when the patient applies
sufficient force by biting on the device or otherwise clamping the
jaws on the device. This enables the device to control the
provision of cyclic forces when the correct amount of force is
applied. In this embodiment, the device includes 1] microprocessor
and compliance software and reporting system; 2) ability to provide
cyclic forces at any level; and 3) the ability to only provide the
cyclic force when the teeth apply the correct force on the
device.
[0031] FIG. 3 shows an exemplary diagram of control electronics
used with the system of FIGS. 1-2. The functional electromechanical
components include a processor 50 that can be a low power
microcontroller. The processor 50 stores instructions and data in a
memory 52. The processor drives an actuator 54 such as an
electrical motor or a piezoelectric device, among others. The
system of FIG. 3 receives energy from a battery 62 that can be
rechargeable. The processor 50 can be programmed or updated through
a communication port 60 such as a USB port. Alternatively, the
processor 50 can be wirelessly updated through a wireless
transceiver 58 connected to an antenna 59. The battery 62 can be of
any type and can be a rechargeable type with a bite plate docking
port that recharges the battery upon insertion thereto. The
processor 50 can also communicate with an optional sensor 64 to
capture patient dental data if needed. The processor 50 can also
simply transmits its operational parameters through the
communication port 60 or the wireless transceiver 58 so that a
dental professional such as a dentist, an orthodontist, a
hygienist, a treatment coordinator, a staff member, a patient, or a
third party can monitor treatment progress as required.
[0032] The actuator 54 can include a motor driven post or pillar.
Upon activation, the pillar, which can be of any shape or diameter
that is sufficient to come into and out of contact with the
archwire 34 in a manner that delivers the necessary force, moves
from a resting position to come into contact with the archwire 34
at the midline. The device can have one or more interfaces at other
parts of the archwire, where the two central maxillary incisors
come into mesial contact in the maxilla, and the two central
mandibular incisors come into mesial contact in the mandible. In a
dual-interface embodiment, the device interfaces at each side
between teeth #2 and #3 (lateral incisor/canine teeth) or tooth #5
and #6 (second premolar/first molar teeth) or some other
interproximal point. The post or pillar then returns to the resting
position after coming into contact with the archwire 34 and
applying the necessary force. This movement in total completes one
cycle. The system embodied as the device described here repeats
this cycle at a frequency of between about 0.1 Hetz to about 400
Hertz.
[0033] Although a motorized pillar is discussed above, the means of
generating the cyclic forces for delivery to the teeth or
dentofacial bone structure can be of any form. In one embodiment,
the cyclic force generator is mechanically or electrically induced.
The generator can also apply piezoelectric devices as discussed
above. A mechano-transduction pathway can be embedded in the system
as well. Furthermore, the embodiment of the system can be fixed,
removable, or implantable. The cyclic forces can be also be fluidic
in nature.
[0034] In one embodiment, the archwire interface 32 can transmit a
force of about five Newtons (5N) for about twenty minutes a day at
a frequency of between 0.1 to 400 Hz as discussed above. However,
the prescribed clinical application of forces can be over any
duration, frequency, and time of day combination pattern. Upon
completion of one (1) twenty-minute duration of activation, the
device automatically shuts off. Pacing indicators in the form of an
audible tone provide feedback to the patient regarding elapsed time
and time remaining in the current session of activation. These
indicators can be of any form and frequency; the current described
system embodies the indicators as one second tones at five-minute
intervals for the first fifteen minutes, representing a tone at
minute five, minute ten, and minute fifteen; and then a final tone
at minute nineteen, indicating that the user has 60 seconds of use
remaining. Other indicators and/or suitable treatment intervals can
be used to provide notice to the patient.
[0035] After the device shuts off, the patients simply releases
bite pressure from the intraoral bite plate and removes the device
from the oral cavity. Data capture related to usage frequency and
duration updates real time. As such, the device representation of
this data post-use will indicate one additional session, and twenty
additional minutes in duration of use, as compared to the same
device immediately prior to the session.
[0036] In one embodiment, the battery 62 is rechargeable and can be
inserted into its charger base between uses. Alternatively, the
device can embed the battery 62 within its housing, and the entire
device is placed into a rechargeable base. The charging of the
battery can be done using power from the USB port 60.
Alternatively, any suitable computer or electrical connection can
be provided to charge the battery. For example, the battery can be
charged using RS-232, Firewire, or through a 5V hook. Further, a
standard DC converter can be used to charge the battery. The device
is hermetically sealed to be airtight and water tight, and can
withstand immersion or exposure to water or moisture. It can and
should be stored at room temperature. The battery 62 used in this
particular embodiment is both memory-free and maintenance-free. The
device can have a charger base, or can be inserted just long enough
to charge for the next use.
[0037] The application of cyclic forces can be used to perform bone
modeling and/or remodeling as well as more rapid tooth movement
that may occur without bone modeling or remodeling. The bone and
accelerate tooth movement across all types of displacement
includes: rotation, translation, intrusion, extrusion, and tipping.
This induced accelerated remodeling of bone is relevant for both
the alignment and movement of teeth, in any plane, including
horizontal and vertical, anterior and posterior, mesial and distal,
and facial (buccal and labial) and lingual.
[0038] The delivery of the cyclic forces to the teeth and
craniofacial bones can be facilitated by contact or any form of
interaction with the archwire, the orthodontic brackets, any other
externally or internally placed orthodontic system component, any
dental tissue including tissues of the tooth, enamel, dentin,
cementum, and pulp, and any other appliance of any type, fixed or
removable, and including aligner trays of any commercial or
non-commercial brand or design. The system can be used with
brackets, archwires, and any other externally placed orthodontic
system component such as self-ligating appliances or palatal
expanders, and it can be used with all commercial or non-commercial
constituents of any material, physical or chemical property, shape,
or size.
[0039] The system is compatible with any and all orthodontic
appliances, both fixed and removable, and instruments, commercial
and regardless of brand, or non-commercial. Such appliances include
but are not limited to all archwires, brackets, palatal expanders,
lip bumbers, distal jet appliances, Herbst appliances, retainers,
bionators, lingual bars, Essix retainers, and aligners. The system
can be used in conjunction with lingual braces, facial braces, or
any combination across either arch or any quadrant for both. It is
also being contemplated as compatible with any robotics-based or
other wire-bending optimization technology. The system is also
compatible with clear aligner technology, including the
Invisalign.RTM. treatment approach.
[0040] The system can be used in conjunction with a new treatment
start from the very first appointment at which the orthodontic
treatment begins, or it can be slotted into a treatment in progress
at any point during the course of the treatment, up to and
including the very last clinical stage.
[0041] An embodiment of the system can be made available for sale
directly to consumers over-the-counter with no orthodontist or
healthcare professional involvement. The application being
contemplated can be used to both align and mal-align either a
single tooth, the entire dentition, or any combination of teeth
groups. Teeth being displaced as a result of the non-static forces
delivered by this device can include natural teeth without any
dental work, natural teeth with dental work including operative
restoration of any nature with any material, crown and bridge work,
endodontically treated teeth, periodontally treated teeth, teeth
surrounded by periodontally treated hard and soft tissue, and any
type of dental implant, including micro implants used for
orthodontic or tooth movement purposes. The proposed system can be
used in conjunction with any type of dental or dentofacial surgery
or treatment of trauma to any soft or hard tissue structure.
[0042] In another aspect, the system of FIGS. 1-3 can be used in
conjunction with any currently used or in-development chemical,
biochemical, and tissue engineering treatment approaches to
accelerating tooth movement or remodeling craniofacial bone. These
treatments may include growth factors, cytokines, matrix
metalloproteinases (MMPs), tissue inhibitors of metalloproteinases
(TIMPs), and regulation of extracellular matrix molecules. In
addition, for both repositioning or stabilizing, tissue remodeling
and/or an angiogenic substance(s) can be administered to the
patient to promote remodeling of periodontal tissue surrounding the
root(s) of the tooth or teeth to be moved. Preferred substance(s)
will bind to and activate the relaxin receptor in the tissues which
anchor the teeth or other craniofacial structures. Most preferred
is relaxin or an analog or mimetic thereof which combines tissue
remodeling activity with angiogenic activity. Analogs include
peptides, oligomers, fragments, etc. which comprise the active
region of native relaxin and mimetics include small molecule drugs,
typically below 2 kD, designed to mimic the activity of native
relaxin. Alternatively, substance(s) with predominantly angiogenic
activity could be selected, such as VEGF, bFGF, estrogen, nitrous
oxide, naltrexone, or the like. Further alternatively, collagenases
or other tissue-softening enzymes could be utilized to promote
periodontal tissue remodeling according to the present invention.
In some instances, it may be desirable to combine two or more
tissue remodeling and/or angiogenic substance(s) having differing
activities. In other instances it may be desirable to deliver
different tissue remodeling and/or angiogenic substance(s) at
different times during the orthodontic treatment and/or to
different regions of the periodontal tissue. The term "relaxin"
means human relaxin, including intact full length relaxin or a
portion of the relaxin molecule that retains biological activity,
as described in U.S. Pat. No. 5,023,321, preferably recombinant
human relaxin (H2), and other active agents with relaxin-like
activity, such as Relaxin and portions that retain biological
activity Like Factor (as described in U.S. Pat. No. 5,911,997),
relaxin analogs and portions that retain biological activity (as
described in U.S. Pat. No. 5,811,395), and agents that
competitively displace bound relaxin from a receptor. Relaxin can
be made by any method known to those skilled in the art, for
example, as described in any of U.S. Pat. Nos. 5,759,807; 4,835,251
and co-pending U.S. Ser. No. 07/908,766 (PCT US90/02085) and Ser.
No. 08/080,354 (PCT US94/0699). More information on applying
relaxin to stabilize teeth movement is described in 20040115587 and
the foregoing patents, the contents of which are incorporated by
reference. It can also be used in conjunction with currently
existing, in-development, or emerging treatments related to
innovative mechanotherapy, gene therapy, and growth factor
delivery. Relevant sutural genetic considerations to the system
include genes expressed in development, genes responsible for
craniosynostosis/dentofacial deformities, and phenotypes in normal
and abnormal development.
[0043] FIG. 4 shows an exemplary dental treatment network. The
device 10 of FIG. 1 transmits operational and dental/medical
information while embedded in a patient 1. The data is received by
a local processor 99. The local processor 99 in turn uploads the
information over a wide area network 100 such as the Internet. The
data can be received by a treating professional such as a dentist
or an orthodontist at workstation 120. The information can also be
sent to one or more diagnostic specialists 130 who review the
information and then make recommendation to the treating
professional over the network 100. The information can also be sent
to the device's manufacturer 110 and any other required dental
supplier 140.
[0044] An Internet community with one or more dental supply
companies, service providers, manufacturers, or marketers is
connected to the network 102 and can communicate directly with
users of the client workstations 99 or indirectly through the
server 100. The Internet community provides the client workstations
99 with access to a network of orthodontic specialists and dental
specialists. Additionally, the Internet community also provides
access to a variety of supporting members such as financing firms,
leasing firms and other service providers, among others.
[0045] Although the server 100 can be an individual server, the
server 100 can also be a cluster of redundant servers. Such a
cluster can provide automatic data failover, protecting against
both hardware and software faults. In this environment, a plurality
of servers provides resources independent of each other until one
of the servers fails. Each server can continuously monitor other
servers. When one of the servers is unable to respond, the failover
process begins. The surviving server acquires the shared drives and
volumes of the failed server and mounts the volumes contained on
the shared drives. Applications that use the shared drives can also
be started on the surviving server after the failover. As soon as
the failed server is booted up and the communication between
servers indicates that the server is ready to own its shared
drives, the servers automatically start the recovery process.
Additionally, a server farm can be used. Network requests and
server load conditions can be tracked in real time by the server
farm controller, and the request can be distributed across the farm
of servers to optimize responsiveness and system capacity. When
necessary, the farm can automatically and transparently place
additional server capacity in service as traffic load
increases.
[0046] The server 100 can also be protected by a firewall. When the
firewall receives a network packet from the network 102, it
determines whether the transmission is authorized. If so, the
firewall examines the header within the packet to determine what
encryption algorithm was used to encrypt the packet. Using this
algorithm and a secret key, the firewall decrypts the data and
addresses of the source and destination firewalls and sends the
data to the server 100. If both the source and destination are
firewalls, the only addresses visible (i.e., unencrypted) on the
network are those of the firewall. The addresses of computers on
the internal networks, and, hence, the internal network topology,
are hidden. This is called "virtual private networking" (VPN).
[0047] The server 100 supports a real estate transaction portal
that provides a single point of integration, access, and navigation
through the multiple enterprise systems and information sources
facing knowledge users operating the client workstations 99. The
portal can additionally support services that are transaction
driven. Once such service is advertising: each time the user
accesses the portal, the client workstation 99 downloads
information from the server 100. The information can contain
commercial messages/links or can contain downloadable software.
Based on data collected on users, advertisers may selectively
broadcast messages to users. Messages can be sent through banner
advertisements, which are images displayed in a window of the
portal. A user can click on the image and be routed to an
advertiser's Web-site. Advertisers pay for the number of
advertisements displayed, the number of times users click on
advertisements, or based on other criteria. Alternatively, the
portal supports sponsorship programs, which involve providing an
advertiser the right to be displayed on the face of the port or on
a drop down menu for a specified period of time, usually one year
or less and the sponsorship programs enable campaigning and
additional business models. The portal also supports
performance-based arrangements whose payments are dependent on the
success of an advertising campaign, which may be measured by the
number of times users visit a Web-site, purchase products or
register for services. The portal can refer users to advertisers'
Web-sites when they log on to the portal.
[0048] Additionally, the portal offers contents and forums
providing focused articles, valuable insights, questions and
answers, and value-added information about related issues,
including information on dental issues. Other services can be
supported as well. For example, a user can rent space on the server
to enable him/her to download application software (applets) and/or
data--anytime and anywhere. By off-loading the storage on the
server, the user minimizes the memory required on the client
workstation 99, thus enabling complex operations to run on minimal
computers such as handheld computers and yet still ensures that
he/she can access the application and related information anywhere
anytime. Another service is On-line Software Distribution/Rental
Service. The portal can distribute its software and other software
companies from its server. Additionally, the portal can rent the
software so that the user pays only for the actual usage of the
software. Such software can include facial modeling software that
renders the expected teeth position with the facial image of the
patient. After each use, the application is erased and will be
reloaded when next needed, after paying another transaction usage
fee.
[0049] The server 100 allows a consumer to log onto a computerized
orthodontic transaction system over a network and automates the
steps required to complete a treatment. In addition, information
relating to the various portions of a transaction are captured and
stored in a single convenient location where it can be accessed at
any time.
[0050] The system has several benefits and advantages related to
patient and user compliance. It provides a means by which the
healthcare professional patient or third-party, like a parent, can
observe the usage patterns by the patient related to the device
delivering cyclic forces in order to accelerate bone remodeling.
The elements of compliance that can be tracked include but are not
limited to duration of use, frequency of use, confirmation of use
by the prescribed patient and not someone else, confirmation of use
by the prescribed patient as intended, and any patterns related to
misuse or abuse including overuse and underuse. Data analysis as a
means of providing rewards or punishment of any form for proper or
improper use is also a part of the contemplated system. Adjoining
any form of pleasurable activity including listening to music to
the use of the system is another benefit. The proposed device can
be compatible with any type of analog or digital music player.
[0051] The means of data observation by the healthcare professional
can be computer-based and compatible with any and all operating
systems and software/hardware configurations, or via any other form
of electronic media. Facilitation of data upload could be via USB
port or any other means of transfer.
[0052] The system can be rechargeable or non-rechargeable and can
be configured in a manner that would allow either patient mobility
or immobility during use. It can be programmed with specific
instructions and usage pattern directions by the healthcare
professional to ensure safety or for other reasons, and is
configured to give the healthcare professional the option of not
allowing the patient to have control over the programmed
settings.
[0053] Data captured can be analyzed by the healthcare professional
across any analytical method, approach, or configuration. Data
captured can be represented graphically, semantically, or in any
other format. Data can be monitored and controlled via the
internet.
[0054] Another aspect of this system includes a computer
implemented system by which active or passive feedback can be
provided to the patient. The capability can exist for any data
element related to use or misuse to which the healthcare
professional will have visibility to be made available to the
patient in any graphic, semantic, or other form. Furthermore, the
capability can exist for the data in the same aforementioned manner
to be made available to the parent or legal guardian of the
patient, but not the patient himself. Another feedback
contemplation of the current system allows the healthcare
professional to real-time track usage by the patient across any
data element.
[0055] In accordance with the contemplated business aspects of the
system, an economic model is created which allows the orthodontic
or other healthcare professional office to rent, lease, or sell the
system to patients. It can be used as a means of generating profit
within the treatment office, or can be passed on to the patient
under any agreement without incremental mark-up for any reason,
including as a means of promoting the healthcare professional
practice. Lease and rental agreements related to the system can be
set up with any term structure and can be configured to allow the
orthodontist or other healthcare professional discretion as to the
pricing and terms of the agreement with the patient or legal
guardian of the patient. The system can be leased or rented to the
orthodontist or other healthcare professional by the
commercializing organization so that it is charged pro rata to any
time period increment, especially monthly. The channel strategy
used to market the current system can be configured so that the
point of sale, rent, or lease is established directly between the
commercializing organization and the orthodontic or other
healthcare professional office, or it can be established through a
leasing company or other third party intermediary, and through any
number of such intermediaries.
[0056] Through any channel of trade, consumer or professional,
volume discounts can be configured, and family or sibling discount
programs can be developed for multiple users in a single household.
Furthermore, the system contemplates the development of guarantee
and warranty programs related to all aspects of the system
performance including but not limited to defects and clinical
results.
[0057] In yet another aspect, components of the system can be
recycled, either as a complete unit or at any combination level of
components. The benefit of such recycling is that the
commercializing organization can establish any number or form of
campaigns related to providing rewards to the orthodontist, other
healthcare professional, patient, or legal guardian as recycled
parts are procured. In the contemplation of a direct-to-consumer
product, all aforementioned campaigns and programs can be
established with any channel partner or retailer.
[0058] The system improves patient compliance, defined as duration
of device use/wear, frequency of device use/wear, consistency in
time of day device use/wear, and correct device use/wear such data
is captured in data form by the device. Compliance refers to both
not overusing and not underusing the device in accordance with the
instructions given to the patient by the healthcare professional.
This data can be viewed by the healthcare professional, as shown in
FIG. 5. In this embodiment, instructions for use and wear are
provided to the patient by the healthcare professional (51 0). The
patient uses/wears the device, and data on compliance is captured
during patient use (512). After each treatment period, the device
is retrieved by the professional and compliance data is extracted
therefrom (514). The data is presented in a form that will allow
for data analysis by the healthcare professional (516).
[0059] As shown in FIG. 6, the data can be provided for feedback
purposes as well. During use, the device can provide a visual
feedback upon request (612) from the patient or automatically
(614). The data can be downloaded (616) into an electronic media
620 such as a flash drive and the information can be sent to the
professional for feedback and analysis (618). The device can also
be configured as seen in FIG. 6 to provide either active or passive
feedback to the patient user. This data generation and observation
can be enabled by a request via download with some form of
electronic media, or delivered as a default setting during use.
[0060] An additional aspect of the proposed system is related to
the efficiency improvement that it allows and enables within the
orthodontic or other healthcare professional office. It can be used
to decrease treatment duration times, increase the number of new
starts, improve financial performance of the practice across any
metric, attract new patients, recruit former treatment-rejecters,
and improve relations with upstream or downstream referring or
referral dental/medical professionals of any discipline or
specialty.
[0061] FIG. 7 demonstrates an exemplary distribution system by
company 700 where the device 10 is leased or rented to the patient
730 through the orthodontic office 720, allowing for the patient
fee to be proportional to the amount of time that the device is
used as a part of the treatment. Alternatively, the patient can
purchase the appliance instead of leasing or renting the device
10.
[0062] Healthcare professional efficiency increases as a result of
patients using the system. This improvement could include metrics
such as an increased number of new case starts, a shorter duration
of total treatment time, or a decreased amount of chairside time,
as shown in FIG. 8. In FIG. 8, the orthodontic office achieves a
steady state in office and case efficiency with the devices (810).
Additionally, as the adoption of the technology is increased and
the devices are incorporated into patient cases, an improvement in
the office and case efficiency is achieved (820).
[0063] FIGS. 9-10 show an exemplary process to compare differences
in pain level for patients treated with and without the appliances
of FIG. 1. FIG. 9 demonstrates a decrease in patient pain and
discomfort as a result of using the device while FIG. 10
demonstrates an improvement in treatment outcomes as a result of
this device. In FIG. 9, the healthcare professional treats the
patient without the device of the present invention (910) and the
level of pain and/or discomfort is observed by the treating
professional or reported by the patient. The healthcare
professional then treats the patient with the device of the present
invention and the level of pain and/or discomfort is observed by
the treating professional or reported by the patient is captured
(920). The difference between the pain level in patients treated
with or without the device can be analyzed. The device treats
patient with less pain, and the treatment result could be in the
form of improved tissue integrity. The improved result could be
observed immediately following the treatment or indefinitely into
the future beyond the end of the treatment. The corresponding
operations 930 and 940 are shown in FIG. 10.
[0064] Expanded indications and applications related to the current
system include pain reduction and improved clinical results through
improved tissue and bone integrity. The contemplated reduction of
pain applies to initial adjustments during orthodontic visits,
ongoing discomfort levels between orthodontic visits, and
post-treatment with any dentofacial surgery procedure, including
trauma and correction of any form. Levels of discomfort are
typically the highest immediately post-adjustment because the
tension that is lost due the movement of teeth is recovered by
tightening the archwire. The current system intermittently
increases and then releases this constant pressure at a high
frequency. The resulting perception to the patient is less pain and
discomfort. This observation is partially due to the fact that the
device distracts the patient's attention away from the pain; but it
is also a result of the subtle release of pressure with the back
half of each cycle as the device pillar comes out of contact with
the archwire.
[0065] The contemplated tissue integrity improvement is related to
any component of the periodontium: alveolar bone, periodontal
ligament (PDL), cementum tissue, and gingivae. Such a bone
integrity and related density improvement also extends to all other
dentofacial bone applications, including bone-healing applications
related to the treatment of trauma. The benefit of such an
improvement allows for a more stable result with a higher degree of
treatment retention and resulting less treatment relapse as related
to the teeth remaining in their post-treatment position as opposed
to migrating back to their pre-treatment positions. Patients with
improved bone density and tissue integrity do not have to follow
the post-treatment retention and retainer regimens that are as
rigid. From a functional and structural perspective, over time the
occlusion of the upper and lower arches then generates less
unnecessary wear to the surfaces of the teeth because the
supporting bone and other tissue structures are stronger and
provide a steady foundation. A stronger periodontium also has the
benefit of more stable overall oral health.
[0066] The above system is advantageous in providing improvement of
patient compliance, development of a leasing business model,
improvement of healthcare professional office efficiency, and
enhancement of treatment outcomes through reduced pain and stronger
tissue and stability. The device utilizes the application of non
static forces. Said forces can be cyclic in nature and application.
Malocclusion refers to the misalignment of teeth and/or incorrect
relation between the teeth of the two dental arches. Patient
compliance involves behavior as it relates to following treatment
instructions and recommendations given by the healthcare
professional. In one embodiment, the proposed system would be
rented through a leasing business model to patients through
healthcare professional offices as an intermediary, and serve as a
means of increasing office throughput and efficiency. The system
designed as a medical device in this way decreases patient pain and
discomfort and improves tissue integrity and clinical results.
[0067] The invention has been described herein in considerable
detail to provide those skilled in the art with the information
needed to apply the novel principles and to construct and use such
specialized components as are required. However, it is to be
understood that the invention can be carried out by specifically
different equipment and devices, and that various modifications,
both as to the equipment details and operating procedures, can be
accomplished without departing from the scope of the invention
itself. It will be recognized by those skilled in the art that
changes may be made to the above-described embodiments of the
system without departing from the broad inventive concepts thereof.
It is understood therefore, that this system is not limited to the
particular embodiment disclosed, but is intended to cover any
modifications that are within the scope and spirit of the system as
defined by the appended claims.
* * * * *