U.S. patent application number 14/084311 was filed with the patent office on 2014-03-20 for systems and methods to provide communication and monitoring of user status.
This patent application is currently assigned to SONITUS MEDICAL, INC.. The applicant listed for this patent is Sonitus Medical, Inc.. Invention is credited to Amir A. ABOLFATHI, John SPIRIDIGLIOZZI.
Application Number | 20140081091 14/084311 |
Document ID | / |
Family ID | 41013459 |
Filed Date | 2014-03-20 |
United States Patent
Application |
20140081091 |
Kind Code |
A1 |
ABOLFATHI; Amir A. ; et
al. |
March 20, 2014 |
SYSTEMS AND METHODS TO PROVIDE COMMUNICATION AND MONITORING OF USER
STATUS
Abstract
An electronic and transducer device can be attached, adhered, or
otherwise embedded into or upon a removable oral appliance or other
oral device to form a two-way communication assembly. The device
contains a motion sensor to detect external forces imposed on the
user such as an explosion, for example. The information is stored
for medical treatment, among others. In another embodiment, the
device provides an electronic and transducer device that can be
attached, adhered, or otherwise embedded into or upon a removable
oral appliance or other oral device to form a medical tag
containing patient identifiable information. Such an oral appliance
may be a custom-made device fabricated from a thermal forming
process utilizing a replicate model of a dental structure obtained
by conventional dental impression methods. The electronic and
transducer assembly may receive incoming sounds either directly or
through a receiver to process and amplify the signals and transmit
the processed sounds via a vibrating transducer element coupled to
a tooth or other bone structure, such as the maxillary, mandibular,
or palatine bone structure.
Inventors: |
ABOLFATHI; Amir A.;
(Woodside, CA) ; SPIRIDIGLIOZZI; John; (Boston,
MA) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Sonitus Medical, Inc. |
San Mateo |
CA |
US |
|
|
Assignee: |
SONITUS MEDICAL, INC.
San Mateo
CA
|
Family ID: |
41013459 |
Appl. No.: |
14/084311 |
Filed: |
November 19, 2013 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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13208588 |
Aug 12, 2011 |
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14084311 |
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12041100 |
Mar 3, 2008 |
8023676 |
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13208588 |
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Current U.S.
Class: |
600/301 ;
600/300; 600/508; 600/509; 600/529; 600/595 |
Current CPC
Class: |
A61B 5/4547 20130101;
A61B 5/0028 20130101; B33Y 70/00 20141201; B33Y 80/00 20141201;
A61B 5/1117 20130101; A61B 2562/0219 20130101; A61B 5/11 20130101;
A61B 5/0816 20130101; A61C 7/08 20130101; A61B 5/0402 20130101;
A63B 71/085 20130101; A61B 7/04 20130101; A61B 5/0022 20130101;
A61B 2503/20 20130101; A61B 5/7455 20130101; A61B 5/1112 20130101;
A61B 5/02438 20130101; A61B 5/682 20130101; A61B 5/72 20130101;
A61B 5/0006 20130101 |
Class at
Publication: |
600/301 ;
600/300; 600/508; 600/509; 600/529; 600/595 |
International
Class: |
A61B 5/00 20060101
A61B005/00; A61B 5/0402 20060101 A61B005/0402; A61C 7/08 20060101
A61C007/08; A61B 7/04 20060101 A61B007/04; A63B 71/08 20060101
A63B071/08; A61B 5/024 20060101 A61B005/024; A61B 5/08 20060101
A61B005/08 |
Claims
1. A bone conduction communication apparatus, comprising: a housing
having a shape which is conformable to at least a portion of at
least one tooth of a user; a sensor configured to detect medical
information of the user; an actuatable transducer disposed within
or upon the housing and in vibratory communication with a surface
of the at least one tooth; and a wireless satellite transceiver
coupled to the sensor to communicate to the transducer to provide
received sound to the user and to support global communication for
the user.
2. The apparatus of claim 1 wherein the sensor is further
configured to detect a heart rate, EKG, or respiration rate of the
user.
3. The apparatus of claim 1 further comprising a motion sensor in
communication with the transceiver.
4. The apparatus of claim 1 further comprising one or more
additional sensors in communication with the transceiver.
5. The apparatus of claim 1 further comprising a controller which
is configured to disable the communication apparatus when worn by
an unauthorized user.
6. The apparatus of claim 1 wherein the housing comprises an oral
appliance having a shape which conforms to the at least one
tooth.
7. The apparatus of claim 1 further comprising an electronic
assembly disposed within or upon the housing and which is in
communication with the transducer.
8. The apparatus of claim 7 wherein the electronic assembly further
comprises a power supply in electrical communication with
transducer.
9. The apparatus of claim 7 wherein the electronic assembly further
comprises a processor in electrical communication with the
transducer.
10. The apparatus of claim 9 wherein the electronic assembly
further comprises a microphone for receiving auditory signals and
which is in electrical communication with the processor.
11. The apparatus of claim 7 wherein the electronic assembly
further comprises a receiver in wireless communication with an
externally located transmitter assembly.
12. The apparatus of claim 1 Wherein the housing is configured as a
mouthguard or retainer.
13. The apparatus of claim 1 wherein the housing is adapted to
conform to at least the portion of the at least one tooth via an
interference fit.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application is a continuation of U.S. patent
application Ser. No. 13/208,588 filed Aug. 12, 2011, which is a
continuation of U.S. patent application Ser. No. 12/041,100 filed
Mar. 3, 2008 (now U.S. Pat. No. 8,023,676), each of which is
incorporated herein by reference in its entirety.
BACKGROUND OF THE INVENTION
[0002] Millions of living Americans are serving, or have served,
the nation in the armed services. Indeed, so many Americans have
passed through military service that the Department of Defense
(DoD) and individual branches of the armed forces has developed
more than 60 separate clinical information systems since 1980 in an
effort to keep track. These 60 disparate systems, while useful,
resulted in an even greater diffusion of medical information, which
became more difficult to access with each passing year. Therefore,
the DoD was faced with the need for a "system of systems"--a
comprehensive methodology that could meet the needs of the military
not only in a hospital setting, but also in battlefield conditions.
The solution was CHCS II-T. At full deployment, CHCS II-T will
allow a physician, nurse practitioner or any other provider to get
a patient's complete medical information right at the point of
service, facilitating the delivery of care to active duty
personnel, retirees and beneficiaries. CHCS II-T will ultimately be
deployed on a mobile platform so frontline medical personnel can
use the technology even under battlefield conditions.
[0003] Information technology initiatives, including CHCS II-T and
the Preventive Health Care Application, are moving toward a
complete computerized patient record that will capture and retain
all health care information, improve the delivery of preventive
services and health care, and enhance our understanding of the
health status and needs of service members and their families. For
the deployed military member, these systems will be able to share
information with the PIC technology. The PIC is a wearable
electronic tag that stores an individual's medical status and
history, vaccination records and other essential information that
will interface with CHCS II-T and other existing medical tracking
systems in use in theater of operation. The PIC will be carried by
Service members during deployment and updated by medical personnel
using portable computers whenever the Service member is examined or
treated. PIC information will be transmitted to consolidated
databases to ensure that medical information is not lost if the PIC
is lost or damaged.
[0004] The use of PIC tags, cards, armbands, and other information
sources provides notice of unique medical conditions. In each
instance, however, the individual must make the effort to maintain
this information in a pocket or on his person. U.S. Pat. No.
4,557,693 discloses a device and method for applying and retaining
a data earlier to a tooth surface of an individual. The data
carrier has a thin sheet of material having a data format unique to
the individual. This data carrier is attached to the surface of the
individual's tooth and is adapted for detection by a reader which
can be operated by a third person. The system further comprises a
central data bank which becomes a verification source for
identifying information carried at the individual's tooth
surface.
[0005] In a parallel trend, certain high level members of the
government, police, and military members engage in high risk jobs
and need protection from gunshots and explosions. Conventional
approaches include bullet-proof glass, concrete and steel building
structures, armored cars, bullet-proof jackets, and others. The
particular avenue taken depends on whether the person is
stationary, located in a vehicle, located within a building, or is
required to maintain mobility outside the confines of any specific
stationary structure. U.S. Pat. No. 6,029,558 discloses the use of
an air bag which is rapidly inflated and interposed between the
projectile or concussive force and the person to be protected so as
to either deflect the projectile or reduce the effects of the
concussive force.
SUMMARY OF THE INVENTION
[0006] Methods and apparatus that support communications and/or
medical information monitoring for soldiers are disclosed.
[0007] In one aspect, a bone conduction communication apparatus
includes a housing having a shape which is conformable to at least
a portion of at least one tooth of a user; a motion sensor to
detect a force imposed on the user; an actuatable transducer
disposed within or upon the housing and in vibratory communication
with a surface of the at least one tooth; and a wireless satellite
transceiver coupled to the motion sensor to communicate the force
and coupled to the transducer to provide received sound to the user
and to support global communication for the user.
[0008] In another aspect, an electronic and transducer device can
be attached, adhered, or otherwise embedded into or upon a
removable oral appliance or other oral device to form a two-way
communication assembly. The device contains a motion sensor to
detect external forces imposed on the user such as an explosion,
for example. The information is stored for medical treatment, among
others. In another embodiment, the device provides an electronic
and transducer device that can be attached, adhered, or otherwise
embedded into or upon a removable oral appliance or other oral
device to form a medical tag containing patient identifiable
information. Such an oral appliance may be a custom-made device
fabricated from a thermal forming process utilizing a replicate
model of a dental structure obtained by conventional dental
impression methods. The electronic and transducer assembly may
receive incoming sounds either directly or through a receiver to
process and amplify the signals and transmit the processed sounds
via a vibrating transducer element coupled to a tooth or other bone
structure, such as the maxillary, mandibular, or palatine bone
structure.
[0009] The system reduces paperwork, allows for the collection of
more complete patient information, eliminates redundant data entry,
increases responsiveness to medical situations and enables
healthcare providers to make certain all patient episodes are
captured and recorded no matter the environment. Most importantly;
the system provides a standard of care to our soldiers by providing
access to previously unavailable information. The system is a
multi-purpose medical platform that is rugged, wireless and secure.
The system provides commanders with real time visibility of their
readiness status and provides support for medical command and
control, telemedicine and medical informatics applications across
the continuum of the entire spectrum of military medical operations
but especially for the first responder and far forward medical
facilities. With soldiers deployed in many different parts of the
world, the system allows medical professionals to capture patient
episodes anywhere, anytime, and ensure complete patient information
is recorded and transferred to the soldier's medical record at
home.
[0010] Certain embodiments of the system automatically inflates
Kevlar coated jackets and helmets to protect the user from the
forces of blasts or explosions. These embodiments receive the
output of the motion sensors and detect the presence of
blasts/explosions and cause the vests/helmets to become hardened to
protect the wearer from the blasts/explosions. The system can
provide an automated introduction of a protective, inflatable
shield between the concussive force of a bomb blast or the impact
energy of a projectile, and the body of the person at which it is
directed.
[0011] The system is uniquely tailored to the individual and can
contain tamper-proof electronics that disable the system if the
system is removed from the authorized user and tampered with in
order to be used by an unauthorized user. In this manner, the
system is highly secured. Due to the security, the system can
provide a dental identification means which is retained on the
individual and thus is less subject to destruction, loss,
forgetfulness, or any of the numerous other problems.
BRIEF DESCRIPTION OF THE DRAWINGS
[0012] FIG. 1A shows a first embodiment of an exemplary
communication device and/or medical monitoring device.
[0013] FIG. 1B shows a second embodiment of an exemplary
communication device and/or medical monitoring device.
[0014] FIG. 1C shows a third embodiment of an exemplary
communication device and/or medical monitoring device.
[0015] FIG. 1D illustrates the dentition of a patient's teeth and
one variation of a two-way communication device which is removably
placed upon or against the patient's tooth or teeth as a removable
oral appliance.
[0016] FIG. 2A illustrates a perspective view of the lower teeth
showing one exemplary location for placement of the removable oral
appliance two-way communication device.
[0017] FIG. 2B illustrates another variation of the removable oral
appliance in the form of an appliance which is placed over an
entire row of teeth in the manner of a mouthguard.
[0018] FIG. 2C illustrates another variation of the removable oral
appliance which is supported by an arch.
[0019] FIG. 2D illustrates another variation of an oral appliance
configured as a mouthguard.
[0020] FIG. 3 illustrates a detail perspective view of the oral
appliance positioned upon the patient's teeth utilizable in
combination with a transmitting assembly external to the mouth and
wearable by the patient in another variation of the device.
[0021] FIG. 4 shows an illustrative configuration of the individual
components in a variation of the oral appliance device having an
external transmitting assembly with a receiving and transducer
assembly within the mouth.
[0022] FIG. 5 shows an illustrative configuration of another
variation of the device in which the entire assembly is contained
by the oral appliance within the user's mouth.
[0023] FIG. 6A shows a partial cross-sectional view of an oral
appliance placed upon a tooth with an electronics/transducer
assembly adhered to the tooth surface via an adhesive.
[0024] FIG. 6B shows a partial cross-sectional view of a removable
backing adhered onto an adhesive surface.
[0025] FIG. 7 shows a partial cross-sectional view of another
variation of an oral appliance placed upon a tooth with an
electronics/transducer assembly pressed against the tooth surface
via an osmotic pouch.
[0026] FIG. 8 shows a partial cross-sectional view of another
variation of an oral appliance placed Upon a tooth with an
electronics/transducer assembly pressed against the tooth surface
via one or more biasing elements.
[0027] FIG. 9 illustrates another variation of an oral appliance
having an electronics assembly and a transducer assembly separated
from one another within the electronics and transducer housing of
the oral appliance.
[0028] FIGS. 10 and 11 illustrate additional variations of oral
appliances in which the electronics and transducer assembly are
maintainable against the tooth surface via a ramped surface and a
biasing element.
[0029] FIG. 12 shows yet another variation of an oral appliance
having an interfacing member positioned between the electronics
and/or transducer assembly and the tooth surface.
[0030] FIG. 13 shows yet another variation of an oral appliance
having an actuatable mechanism for urging the electronics and/or
transducer assembly against the tooth surface.
[0031] FIG. 14 shows yet another variation of an oral appliance
having a cam mechanism for urging the electronics and/or transducer
assembly against the tooth surface.
[0032] FIG. 15 shows yet another variation of an oral appliance
having a separate transducer mechanism positionable upon the
occlusal surface of the tooth for transmitting vibrations.
[0033] FIG. 16 illustrates another variation of an oral appliance
having a mechanism for urging the electronics and/or transducer
assembly against the tooth surface utilizing a bite-actuated
mechanism.
[0034] FIG. 17 shows yet another variation of an oral appliance
having a composite dental anchor for coupling the transducer to the
tooth.
[0035] FIGS. 18A and 18B show side and top views, respectively, of
an oral appliance variation having one or more transducers which
may be positioned over the occlusal surface of the tooth.
[0036] FIGS. 19A and 19B illustrate yet another variation of an
oral appliance made from a shape memory material in its pre-formed
relaxed configuration and its deformed configuration when placed
over or upon the patient's tooth, respectively, to create an
interference fit.
[0037] FIG. 20 illustrates yet another variation of an oral
appliance made from a pre-formed material in which the transducer
may be positioned between the biased side of the oral appliance and
the tooth surface.
[0038] FIG. 21 illustrates a variation in which the oral appliance
may be omitted and the electronics and/or transducer assembly may
be attached to a composite dental anchor attached directly to the
tooth surface.
[0039] FIGS. 22A and 22B show partial cross-sectional side and
perspective views, respectively, of another variation of an oral
appliance assembly having its occlusal surface removed or omitted
for patient comfort.
[0040] FIGS. 23A and 23B illustrate perspective and side views,
respectively, of an oral appliance which may be coupled to a screw
or post implanted directly into the underlying bone, such as the
maxillary or mandibular bone.
[0041] FIG. 24 illustrates another variation in which the oral
appliance may be coupled to a screw or post implanted directly into
the palate of a patient.
[0042] FIGS. 25A and 25B illustrate perspective and side views,
respectively, of an oral appliance which may have its transducer
assembly or a coupling member attached to the gingival surface to
conduct vibrations through the gingival tissue and underlying
bone.
[0043] FIG. 26 illustrates an example of how multiple oral
appliance two-way communication assemblies or transducers may be
placed on multiple teeth throughout the patient's mouth.
[0044] FIGS. 27A and 27B illustrate perspective and side views,
respectively, of an oral appliance (similar to a variation shown
above) which may have a microphone unit positioned adjacent to or
upon the gingival surface to physically separate the microphone
from the transducer to attenuate or eliminate feedback.
[0045] FIG. 28 illustrates another variation of a removable oral
appliance supported by an arch and having a microphone unit
integrated within the arch.
[0046] FIG. 29 shows yet another variation illustrating at least
one microphone and optionally additional microphone units
positioned around the user's mouth and in wireless communication
with the electronics and/or transducer assembly.
DETAILED DESCRIPTION OF THE INVENTION
[0047] As shown in FIG. 1A, an exemplary two way communication
device and/or monitoring device 1 is shown. In one embodiment, the
device 1 provides an electronic and transducer device that can be
attached, adhered, or otherwise embedded into or upon an intraoral
appliance/device or a removable oral appliance/device to form a
two-way communication assembly. The appliance or device 1 can be
used by emergency personnel, medical personnel, soldiers, or any
one working in a high noise environment, among others.
[0048] In the embodiment of FIG. 1A, the device 1 is mounted in the
user's mouth. More details on the intraoral device 1 are discussed
below. The device 1 can communicate with one or more body mounted
sensors 2 through a short range personal area network. (PAN). The
device 1 can also communicate with an attention device 4 such as a
flashing light, among others. In case of an emergency with poor
visibility, the attention device 4 can be activated to identify the
wearer so that assistance can be rendered quickly. The device 1,
the sensor 2 and attention device 4 communicates with a long range
transceiver 3A. In the embodiment of FIG. 1A, the system
communicates through a remote server 5A over a long range wireless
area network such as WiMAX.
[0049] In one embodiment, the device 1 provides an electronic and
transducer device that can be attached, adhered, or otherwise
embedded into or upon a removable oral appliance or other oral
device to form a medical tag containing patient identifiable
information. Such an oral appliance may be a custom-made device
fabricated from a thermal forming process utilizing a replicate
model of a dental structure obtained by conventional dental
impression methods. The electronic and transducer assembly may
receive incoming sounds either directly or through a receiver to
process and amplify the signals and transmit the processed sounds
via a vibrating transducer element coupled to a tooth or other bone
structure, such as the maxillary, mandibular, or palatine bone
structure.
[0050] FIG. 1B shows an exemplary embodiment used in high noise
industrial settings. In the embodiment of FIG. 1B, multiple sensors
2 and 2' can be used. Also, the transceiver 3B is a cellular
transceiver that communicates with cellular towers 5B, among
others.
[0051] In a military application as shown in FIG. 1C, the device 1
can include sensors that detect chemicals present in the soldier's
saliva and provide medical information on the soldier.
Additionally, in certain embodiments, the device 1 can also sense
heart rate, EKG, and other bio-signals that can be picked up within
the mouth. Additionally, the device 1 can communicate with the
Medical data collection module 2 that can collect heart rate, EKG,
respiration rate, and other vital signs or medical information. The
device 1 can communicate with the module 2 through various short
range radios such as a Bluetooth radio, for example, or through
body conduction transceivers, among others.
[0052] In another embodiment, the device 1 is custom-fit to the
user and will not be usable by another individual if transplanted
to another user such as through hostile action by an enemy or
through an intentional action by the wearer. This will be done by
the fact that it is custom-fit to the user. Further, in one
embodiment, if the device is tampered with, anti-tampering
circuitry in the device 1 will render the device
non-functional.
[0053] The device 1 can also communicate with a long range
transceiver such as a short-wave transceiver 3A, a cellular
telephone transceiver 3B, or a satellite transceiver 3C. Such
transceivers can be provided within the device 1, or alternatively,
can be body worn. In the embodiment of FIG. 1C, the satellite
transceiver 3C is positioned on a belt worn by the soldier. The
satellite transceiver 3C communicates with the device 1 through the
short range radio such as Bluetooth, for example.
[0054] The device 1 can contain a motion sensor such as an
accelerometer. The motion sensor can store information on external
forces that are imposed on the user such as the forces arising from
a bomb blast. The accelerometer measures the total specific
external force on the sensor. The accelerometer can be a micro
electro-mechanical system (MEMS) device that includes a suspended
cantilever beam or proof mass (also known as seismic mass) with
deflection sensing and circuitry. Other methods of building MEMS
based accelerometers are known.
[0055] In one embodiment, the accelerometer is a 3 axis
accelerometer that can capture the blast vector including direction
and magnitude of the force. The blast vector is stored in memory
and can also be transmitted to a remote monitoring center. For
example, the motion sensor output can be provided to the long range
transceiver for remote monitoring of the well being of the user. If
a blast is detected, medical assistance can be sent to save the
user from harm. In another embodiment, historical blast vector
information can be analyzed for injury trend analysis and
subsequent treatment even if the soldier reports no immediate
medical injury.
[0056] In another embodiment, the accelerometer output is used to
activate a reactive personnel protection system which, upon
detecting the presence of a destructive force or object, interposes
a protective shield between personnel under attack and the force in
an almost instantaneous fashion. To protect against a concussive
blast triggered by a bomb explosion, the output of the
accelerometer triggers a rapid inflation of a vest 7A with an air
bag worn by the user. The air bag can be fabricated from
Kevlar.RTM. or similar materials. The air bag is rapidly inflated
and interposed between a projectile or a concussive force and the
person to be protected so as to either deflect the projectile or
reduce the effects of the concussive force.
[0057] In another embodiment, the airbag can have a linkage 7C to a
helmet 7B and the linkage is automatically inflated when the
accelerometer senses the destructive force of object. When
inflated, the vest 7A, the linkage 7C and the helmet 7B is hardened
to protect the user from neck injury and other bodily harm(s).
[0058] The accelerometer senses an explosion or a bullet by sensing
rapid changes in acceleration and/or air pressure (e.g. the
concussive wave front which accompanies an explosion). Other
devices, such as magnetostrictive transducers, ultrasonic
transducers, accelerometers, and other mechanical and/or
electro-mechanical sensors can also be applied to sense the
occurrence of a concussive explosion.
[0059] The forces of the concussive explosion and/or vital signs of
the user can be automatically transmitted to a remote monitoring
center that can dispatch help if required. An exemplary process to
collect medical information from the patient and for supporting
bone-conduction two way communication can be as follows: [0060]
Periodically collect medical information [0061] Check to see if the
soldier is using the long range transceiver for talking [0062] If
long range transceiver is not used for talking, upload medical
history of the soldier to a remote computer over the long range
transceiver [0063] Remote computer detects if the medical data
falls outside of an acceptable range that requires medical
intervention [0064] If medical intervention is required, the remote
computer alerts the soldier's commander for action to assist the
soldier [0065] Self-help instructions can be sent through the
satellite transceiver to the bone conduction communication device
1
[0066] In one embodiment, the medical data would include soldier
identification, triage status, condition, and treatment. The data
would be routed via the satellite transceiver to a Command Post
where it is processed, stored, relayed to the Internet, and moved
back to devices on the field. As a result, data on casualties would
be accessible immediately for operational use by other soldiers,
medics, responders, incident commanders and even receiving
hospitals that can help the soldier. Real-time information
regarding victims and their status is critical to the overall
management of field medical care. Medical command can then
coordinate timely information on the number of casualties and their
needs with the known availability of resources, such as on-scene
providers, ambulance locations, and area hospital capacities.
Real-time information is also provided for determining the
appropriate patient destination, depending on the type of injuries
and the capabilities of the receiving facilities.
[0067] In another embodiment, the remote computer can support a
BATTLEFIELD MEDICAL INFORMATION SYSTEMS TACTICAL-JOINT (BMIST-J)
for enabling military providers to record, store, retrieve and
transfer medical records to the DoD's Clinical Data Repository by
synchronizing the received data. The system supports digital
versions of the DD 1380 (field medical card) and SF 600
(chronological medical record of care). Diagnostic and treatment
decision aids are provided by the system. The data captured by the
device 1 is also Personal Information Carrier (PIC) compatible. The
system provides a secure, legible, electronic records of
battlefield treatments, contributes to a comprehensive, life-long
medical history, and facilitates medical surveillance.
[0068] Turning now to more details on the device 1, as shown in
FIG. 1D, a patient's mouth and dentition 10 is illustrated showing
one possible location for removably attaching two-way communication
assembly 14 upon or against at least one tooth, such as a molar 12.
The patient's tongue TG and palate PL are also illustrated for
reference. An electronics and/or transducer assembly 16 may be
attached, adhered, or otherwise embedded into or upon the assembly
14, as described below in further detail.
[0069] FIG. 2A shows a perspective view of the patient's lower
dentition illustrating the two-way communication assembly 14
comprising a removable oral appliance 18 and the electronics and/or
transducer assembly 16 positioned along a side surface of the
assembly 14. In this variation, oral appliance 18 may be fitted
upon two molars 12 within tooth engaging channel 20 defined by oral
appliance 18 for stability upon the patient's teeth, although in
other variations, a single molar or tooth may be utilized.
Alternatively, more than two molars may be utilized for the oral
appliance 18 to be attached upon or over. Moreover, electronics
and/or transducer assembly 16 is shown positioned upon a side
surface of oral appliance 18 such that the assembly 16 is aligned
along a buccal surface of the tooth 12; however, other surfaces
such as the lingual surface of the tooth 12 and other positions may
also be utilized. The figures are illustrative of variations and
are not intended to be limiting; accordingly, other configurations
and shapes for oral appliance 18 are intended to be included
herein.
[0070] FIG. 2B shows another variation of a removable oral
appliance in the form of an appliance 15 which is placed over an
entire row of teeth in the manner of a mouthguard. In this
variation, appliance 15 may be configured to cover an entire bottom
row of teeth or alternatively an entire upper row of teeth. In
additional variations, rather than covering the entire rows of
teeth, a majority of the row of teeth may be instead be covered by
appliance 15. Assembly 16 may be positioned along one or more
portions of the oral appliance 15.
[0071] FIG. 2C shows yet another variation of an oral appliance 17
having an arched configuration. In this appliance, one or more
tooth retaining portions 21, 23, which in this variation may be
placed along the upper row of teeth, may be supported by an arch 19
which may lie adjacent or along the palate of the user. As shown,
electronics and/or transducer assembly 16 may be positioned along
one or more portions of the tooth retaining portions 21, 23.
Moreover, although the variation shown illustrates an arch 19 which
may cover only a portion of the palate of the user, other
variations may be configured to have an arch which covers the
entire palate of the user.
[0072] FIG. 2D illustrates yet another variation of an oral
appliance in the form of a mouthguard or retainer 25 which may be
inserted and removed easily from the user's mouth. Such a
mouthguard or retainer 25 may be used in sports where conventional
mouthguards are worn; however, mouthguard or retainer 25 having
assembly 16 integrated therein may be utilized by persons, hearing
impaired or otherwise, who may simply hold the mouthguard or
retainer 25 via grooves or channels 26 between their teeth for
receiving instructions remotely and communicating over a
distance.
[0073] Generally, the volume Of electronics and/or transducer
assembly 16 may be minimized so as to be unobtrusive and as
comfortable to the user when placed in the mouth. Although the size
may be varied, a volume of assembly 16 may be less than 800 cubic
millimeters. This volume is, of course, illustrative and not
limiting as size and volume of assembly 16 and may be varied
accordingly between different users.
[0074] Moreover, removable oral appliance 18 may be fabricated from
various polymeric or a combination of polymeric and metallic
materials using any number of methods, such as computer-aided
machining processes using computer numerical control (CNC) systems
or three-dimensional printing processes, e.g., stereolithography
apparatus (SLA), selective laser sintering (SLS), and/or other
similar processes utilizing three-dimensional geometry of the
patient's dentition, which may be obtained via any number of
techniques. Such techniques may include use of scanned dentition
using intra-oral scanners such as laser, white light, ultrasound,
mechanical three-dimensional touch scanners, magnetic resonance
imaging (MRI), computed tomography (CT), other optical methods,
etc.
[0075] In forming the removable oral appliance 18, the appliance 18
may be optionally formed such that it is molded to fit over the
dentition and at least a portion of the adjacent gingival tissue to
inhibit the entry of food, fluids, and other debris into the oral
appliance 18 and between the transducer assembly and tooth surface.
Moreover, the greater surface area of the oral appliance 18 may
facilitate the placement and configuration of the assembly 16 onto
the appliance 18.
[0076] Additionally, the removable oral appliance 18 may be
optionally fabricated to have a shrinkage factor such that when
placed onto the dentition, oral appliance 18 may be configured to
securely grab onto the tooth or teeth as the appliance 18 may have
a resulting size slightly smaller than the scanned tooth or teeth
upon which the appliance 18 was formed. The fitting may result in a
secure interference fit between the appliance 18 and underlying
dentition.
[0077] In one variation, with assembly 14 positioned upon the
teeth, as shown in FIG. 3, an extra-buccal transmitter assembly 22
located outside the patient's mouth may be utilized to receive
auditory signals for processing and transmission via a wireless
signal 24 to the electronics and/or transducer assembly 16
positioned within the patient's mouth, which may then process and
transmit the processed auditory signals via vibratory conductance
to the underlying tooth and consequently to the patient's inner
ear.
[0078] The transmitter assembly 22, as described in further detail
below, may contain a microphone assembly as well as a transmitter
assembly and may be configured in any number of shapes and forms
worn by the user, such as a watch, necklace, lapel, phone,
belt-mounted device, etc.
[0079] FIG. 4 illustrates a schematic representation of one
variation of two-way communication assembly 14 utilizing an
extra-buccal transmitter assembly 22, which may generally comprise
microphone 30 for receiving sounds and which is electrically
connected to processor 32 for processing the auditory signals. The
assembly 14 includes motion sensor 31 whose output is connected to
processor 32. Motion sensor 31 can be a three axis accelerometer,
among others. For small size, the accelerometer can be a MEMS
accelerometer. Processor 32 may be connected electrically to
transmitter 34 for transmitting the processed signals to the
electronics and/or transducer assembly 16 disposed upon or adjacent
to the user's teeth. The microphone 30 and processor 32 may be
configured to detect and process auditory signals in any
practicable range, but may be configured in one variation to detect
auditory signals ranging from, e.g., 250 Hertz to 20,000 Hertz.
[0080] With respect to microphone 30, a variety of various
microphone systems may be utilized. For instance, microphone 30 may
be a digital, analog, and/or directional type microphone. Such
various types of microphones may be interchangeably configured to
be utilized with the assembly, if so desired.
[0081] Power supply 36 may be connected to each of the components
in transmitter assembly 22 to provide power thereto. The
transmitter signals 24 may be in any wireless form utilizing, e.g.,
radio frequency, ultrasound, microwave, Blue Tooth.RTM. (BLUETOOTH
SIG, INC., Bellevue, Wash.), etc. for transmission to assembly 16.
Assembly 22 may also optionally include one or more input controls
28 that a user may manipulate to adjust various acoustic parameters
of the electronics and/or transducer assembly 16, such as acoustic
focusing, volume control, filtration, muting, frequency
optimization, sound adjustments, and tone adjustments, etc.
[0082] The signals transmitted 24 by transmitter 34 may be received
by electronics and/or transducer assembly 16 via receiver 38, which
may be connected to an internal processor for additional processing
of the received signals. The received signals may be communicated
to transducer 40, which may vibrate correspondingly against a
surface of the tooth to conduct the vibratory signals through the
tooth and bone and subsequently to the middle ear to facilitate
hearing of the user. Transducer 40 may be configured as any number
of different vibratory mechanisms. For instance, in one variation,
transducer 40 may be an electromagnetically actuated transducer. In
other variations, transducer 40 may be in the form of a
piezoelectric crystal having a range of vibratory frequencies,
e.g., between 250 to 4000 Hz.
[0083] Power supply 42 may also be included with assembly 16 to
provide power to the receiver, transducer, and/or processor, if
also included. Although power supply 42 may be a simple battery,
replaceable or permanent, other variations may include a power
supply 42 which is charged by inductance via an external Charger.
Additionally, power supply 42 may alternatively be charged via
direct coupling to an alternating current (AC) or direct current
(DC) source. Other variations may include a power supply 42 which
is charged via a mechanical mechanism, such as an internal pendulum
or slidable electrical inductance charger as known in the art,
which is actuated via, e.g., motions of the jaw and/or movement for
translating the mechanical motion into stored electrical energy for
charging power supply 42.
[0084] In another variation of assembly 16, rather than utilizing
an extra-buccal transmitter, two-way communication assembly 50 may
be configured as an independent assembly contained entirely within
the user's mouth, as shown in FIG. 5. Accordingly, assembly 50 may
include an internal microphone 52 in communication with an on-board
processor 54. Internal microphone 52 may comprise any number of
different types of microphones, as described above. Processor 54
may be used to process any received auditory signals for filtering
and/or amplifying the signals and transmitting them to transducer
56, which is in vibratory contact against the tooth surface. Power
supply 58, as described above, may also be included within assembly
50 for providing power to each of the components of assembly 50 as
necessary.
[0085] In order to transmit the vibrations corresponding to the
received auditory signals efficiently and with minimal loss to the
tooth or teeth, secure mechanical contact between the transducer
and the tooth is ideally maintained to ensure efficient vibratory
communication. Accordingly, any number of mechanisms may be
utilized to maintain this vibratory communication.
[0086] In one variation as shown in FIG. 6A, a partial
cross-sectional view of a removable oral appliance 60 is shown
placed over or upon a tooth TH. Electronics and/or transducer
housing 62 may be seen defined along oral appliance 60 such that
housing 62 is aligned or positioned adjacent to a side suffice,
buccal and/or lingual surface, of the tooth TH. Housing 62 may
provide protection to the electronics and/or transducer assembly
from the environment of the mouth.
[0087] An electronics and/or transducer assembly 64 may be simply
placed, embedded, or encapsulated within housing 62 for contacting
the tooth surface. In this variation, assembly 64 may be adhered
against the tooth surface via an adhesive surface or film 66 such
that contact is maintained between the two. As shown in FIG. 6B, a
removable backing 68 may be adhered onto adhesive surface 66 and
removed prior to placement upon the tooth surface. In this manner,
assembly 64 may be replaced upon the tooth as necessary with
additional electronics and/or transducer assemblies.
[0088] Aside from an adhesive film 66, another alternative may
utilize an expandable or swellable member to ensure a secure
mechanical contact of the transducer against the tooth. As shown in
FIG. 7, an osmotic patch or expandable hydrogel 74 may be placed
between housing 62 and electronics and/or transducer assembly 72.
After placement of oral appliance 60, hydrogel 74 may absorb sonic
fluids, either from any surrounding fluid or from a fluid
introduced into hydrogel 74, such that hydrogel 74 expands in size
to force assembly 72 into contact against the tooth surface.
Assembly 72 may be configured to define a contact suffice 70 having
a relatively smaller contact area to facilitate uniform contact of
the surface 70 against the tooth. Such a contact surface 70 may be
included in any of the variations described herein. Additionally, a
thin encapsulating layer or surface 76 may be placed over housing
62 between contact surface 70 and the underlying tooth to prevent
any debris or additional fluids from entering housing 62.
[0089] Another variation is shown in FIG. 8, which shows
electronics and/or transducer assembly 80 contained within housing
62. In this variation, one or more biasing elements 82, e.g.,
springs, pre-formed shape memory elements, etc., may be placed
between assembly 80 and housing 62 to provide a pressing force on
assembly 80 to urge the device against the underlying tooth
surface, thereby ensuring mechanical contact.
[0090] In yet another variation, the electronics may be contained
as a separate assembly 90 which is encapsulated within housing 62
and the transducer 92 may be maintained separately from assembly 90
but also within housing 62. As shown in FIG. 9, transducer 92 may
be urged against the tooth surface via a spring or other biasing
element 94 and actuated via any of the mechanisms described
above.
[0091] In other variations as shown in FIG. 10, electronics and/or
transducer assembly 100 may be configured to have a ramped surface
102 in apposition to the tooth surface. The surface 102 may be
angled away from the occlusal surface of the tooth. The assembly
100 may be urged via a biasing element or spring 106 which forces
the ramped surface 102 to pivot about a location 104 into contact
against the tooth to ensure contact for the transducer against the
tooth surface.
[0092] FIG. 11 illustrates another similar variation in electronics
and/or transducer assembly 110 also having a ramped surface 112 in
apposition to the tooth surface. In this variation, the ramped
surface 112 may be angled towards the occlusal surface of the
tooth. Likewise, assembly 110 may be urged via a biasing element or
spring 116 which urges the assembly 110 to pivot about its lower
end such that the assembly 110 contacts the tooth surface at a
region 114.
[0093] In yet another variation shown in FIG. 12, electronics
and/or transducer assembly 120 may be positioned within housing 62
with an interface layer 122 positioned between the assembly 120 and
the tooth surface. Interface layer 122 may be configured to conform
against the tooth surface and against assembly 120 such that
vibrations may be transmitted through layer 122 and to the tooth in
a uniform manner. Accordingly, interface layer 122 may be made from
a material which attenuates vibrations minimally. Interface layer
122 may be made in a variety of forms, such as a simple insert, an
O-ring configuration, etc. or even in a gel or paste form, such as
denture or oral paste, etc. Additionally, layer 122 may be
fabricated from various materials, e.g., hard plastics or polymeric
materials, metals, etc.
[0094] FIG. 13 illustrates yet another variation in which
electronics and/or transducer assembly 130 may be urged against the
tooth surface via a mechanical mechanism. As shown, assembly 130
may be attached to a structural member 132 e.g., a threaded member
or a simple shaft, which is connected through housing 62 to an
engagement member 134 located outside housing 62. The user may
rotate engagement member 134 (as indicated by rotational arrow 136)
or simply push upon member 134 (as indicated by linear arrow 138)
to urge assembly 130 into contact against the tooth. Moreover,
actuation of engagement member 134 may be accomplished manually
within the mouth or through the user's cheek or even through
manipulation via the user's tongue against engagement member
134.
[0095] Another variation for a mechanical mechanism is illustrated
in FIG. 14. In this variation, electronics and/or transducer
assembly 140 may define a portion as an engaging surface 142 for
contacting against a cam or lever mechanism 144. Cam or lever
mechanism 144 may be configured to pivot 146 such that actuation of
a lever 148 extending through housing 62 may urge cam or lever
mechanism 144 to push against engaging surface 142 such that
assembly 140 is pressed against the underlying tooth surface.
[0096] In yet another variation, the electronics 150 and the
transducer 152 may be separated from one another such that
electronics 150 remain disposed within housing 62 but transducer
152, connected via wire 154, is located beneath dental oral
appliance 60 along an occlusal surface of the tooth, as shown in
FIG. 15. In such a configuration, vibrations are transmitted via
the transducer 152 through the occlusal surface of the tooth.
Additionally, the user may bite down upon the oral appliance 60 and
transducer 152 to mechanically compress the transducer 152 against
the occlusal surface to further enhance the mechanical contact
between the transducer 152 and underlying tooth to further
facilitate transmission therethrough.
[0097] In the variation of FIG. 16, another example for a
bite-enhanced coupling mechanism is illustrated where electronics
and/or transducer assembly 160 defines an angled interface surface
162 in apposition to a correspondingly angled engaging member 164.
A proximal end of engaging member 164 may extend through housing 62
and terminate in a pusher member 166 positioned over an occlusal
surface of the tooth TH. Once oral appliance 60 is initially placed
over tooth TH, the user may bite down or otherwise press down upon
the top portion of oral appliance 60, thereby pressing down upon
pusher member 166 which in turn pushes down upon engaging member
164, as indicated by the arrow. As engaging member 164 is urged
downwardly towards the gums, its angled surface may push upon the
corresponding and oppositely angled surface 162 to urge assembly
160 against the tooth surface and into a secure mechanical
contact.
[0098] In yet another variation, an electronics and/or transducer
assembly 170 may define a channel or groove 172 along a surface for
engaging a corresponding dental anchor 174, as shown in FIG. 17.
Dental anchor 174 may comprise a light-curable acrylate-based
composite material adhered directly to the tooth surface. Moreover
dental anchor 174 may be configured in a shape which corresponds to
a shape of channel of groove 172 such that the two may be
interfitted in a mating engagement. In this manner, the transducer
in assembly 170 may vibrate directly against dental anchor 174
which may then transmit these signals directly into the tooth
TH.
[0099] FIGS. 18A and 18B show partial cross-sectional side and top
views, respectively, of another variation in which oral appliance
180 may define a number of channels or grooves 184 along a top
portion of oral appliance 180. Within these channels or grooves
184, one or more transducers 182, 186, 188, 190 may be disposed
such that they are in contact with the occlusal surface of the
tooth and each of these transducers may be tuned to transmit
frequencies uniformly. Alternatively, each of these transducers may
be tuned to transmit only at specified frequency ranges.
Accordingly, each transducer can be programmed or preset for a
different frequency response such that each transducer may be
optimized for a different frequency response and/or transmission to
deliver a relatively high-fidelity sound to the user.
[0100] In yet another variation, FIGS. 19A and 19B illustrate an
oral appliance 200 which may be pre-formed from a shape memory
polymer or alloy or a superelastic material such as a
Nickel-Titanium alloy, e.g., Nitinol. FIG. 19A shows oral appliance
200 in a first configuration where members 202, 204 are in an
unbiased memory configuration. When placed upon or against the
tooth TH, members 202, 204 may be deflected into a second
configuration where members 202', 204' are deformed to engage tooth
TH in a secure interference fit, as shown in FIG. 19B. The biased
member 204' may be utilized to press the electronics and/or
transducer assembly contained therein against the tooth surface as
well as to maintain securement of the oral appliance 200 upon the
tooth TH.
[0101] Similarly, as shown in FIG. 20, removable oral appliance 210
may have biased members to secure engage the tooth TH, as above. In
this variation, the ends of the members 212, 214 may be configured
into curved portions under which a transducer element 218 coupled
to electronics assembly 216 may be wedged or otherwise secured to
ensure mechanical contact against the tooth surface.
[0102] FIG. 21 shows yet another variation in which the oral
appliance is omitted entirely. Here, a composite dental anchor or
bracket 226, as described above, may be adhered directly onto the
tooth surface. Alternatively, bracket 226 may be comprised of a
biocompatible material, e.g., stainless steel, Nickel-Titanium,
Nickel, ceramics, composites, etc., formed into a bracket and
anchored onto the tooth surface. The bracket 226 may be configured
to have a shape 228 over which an electronics and/or transducer
assembly 220 may be slid over or upon via a channel 222 having a
corresponding receiving configuration 224 for engagement with
bracket 226. In this manner, assembly 220 may be directly engaged
against bracket 226, through which a transducer may directly
vibrate into the underlying tooth TH. Additionally, in the event
that assembly 220 is removed from the tooth TH, assembly 220 may be
simply slid or rotated off bracket 226 and a replacement assembly
may be put in its place upon bracket 226.
[0103] FIGS. 22A and 22B show partial cross-sectional side and
perspective views, respectively, of yet another variation of an
oral appliance 230. In this variation, the oral appliance 230 may
be configured to omit an occlusal surface portion of the oral
appliance 230 and instead engages the side surfaces of the tooth
TH, such as the lingual and buccal surfaces only. The electronics
and/or transducer assembly 234 may be contained, as above, within a
housing 232 for contact against the tooth surface. Additionally, as
shown in FIG. 22B, one or more optional cross-members 236 may
connect the side portions of the oral appliance 230 to provide some
structural stability when placed upon the tooth. This variation may
define an occlusal surface opening 238 such that when placed upon
the tooth, the user may freely bite down directly upon the natural
occlusal surface of the tooth unobstructed by the oral appliance
device, thereby providing for enhanced comfort to the user.
[0104] In yet other variations, vibrations may be transmitted
directly into the underlying bone or tissue structures rather than
transmitting directly through the tooth or teeth of the user. As
shown in FIG. 23A, an oral appliance 240 is illustrated positioned
upon the user's tooth, in this example upon a molar located along
the upper row of teeth. The electronics and/or transducer assembly
242 is shown as being located along the buccal surface of the
tooth. Rather than utilizing a transducer in contact with the tooth
surface, a conduction transmission member 244, such as a rigid or
solid metallic member, may be coupled to the transducer in assembly
242 and extend from oral appliance 240 to a post or screw 246 which
is implanted directly into the underlying bone 248, such as the
maxillary bone, as shown in the partial cross-sectional view of
FIG. 23B. As the distal end of transmission member 244 is coupled
directly to post or screw 246, the vibrations generated by the
transducer may be transmitted through transmission member 244 and
directly into post or screw 246, which in turn transmits the
vibrations directly into and through the bone 248 for transmission
to the user's inner ear.
[0105] FIG. 24 illustrates a partial cross-sectional view of an
oral appliance 250 placed upon the user's tooth TH with the
electronics and/or transducer assembly 252 located along the
lingual surface of the tooth. Similarly, the vibrations may be
transmitted through the conduction transmission member 244 and
directly into post or screw 246, which in this example is implanted
into the palatine bone PL. Other variations may utilize this
arrangement located along the lower row of teeth for transmission
to a post or screw 246 drilled into the mandibular bone.
[0106] In yet another variation, rather utilizing a post or screw
drilled into the underlying bone itself, a transducer may be
attached, coupled, or otherwise adhered directly to the gingival
tissue surface adjacent to the teeth. As shown in FIGS. 25A and
25B, an oral appliance 260 may have an electronics assembly 262
positioned along its side with an electrical wire 264 extending
therefrom to a transducer assembly 266 attached to the gingival
tissue surface 268 next to the tooth TH. Transducer assembly 266
may be attached to the tissue surface 268 via an adhesive,
structural support arm extending from oral appliance 260, a dental
screw or post, or any other structural mechanism. In use, the
transducer may vibrate and transmit directly into the underlying
gingival tissue, which may conduct the signals to the underlying
bone.
[0107] For any of the variations described above, they may be
utilized as a single device or in combination with any other
variation herein, as practicable, to achieve the desired hearing
level in the user. Moreover, more than one oral appliance device
and electronics and/or transducer assemblies may be utilized at any
one time. For example, FIG. 26 illustrates one example where
multiple transducer assemblies 270, 272, 274, 276 may be placed on
multiple teeth. Although shown on the lower row of teeth, multiple
assemblies may alternatively be positioned and located along the
upper row of teeth or both rows as well. Moreover, each of the
assemblies may be configured to transmit vibrations within a
uniform frequency range. Alternatively in other variations,
different assemblies may be configured to vibrate within
non-overlapping frequency ranges between each assembly. As
mentioned above, each transducer 270, 272, 274, 276 can be
programmed or preset for a different frequency response such that
each transducer may be optimized for a different frequency response
and/or transmission to deliver a relatively high-fidelity sound to
the user.
[0108] Moreover, each of the different transducers 270, 272, 274,
276 can also be programmed to vibrate in a manner which indicates
the directionality of sound received by the microphone worn by the
user. For example, different transducers positioned at different
locations within the user's mouth can vibrate in a specified manner
by providing sound or vibrational queues to inform the user which
direction a sound was detected relative to an orientation of the
user. For instance, a first transducer located, e.g., on a user's
left tooth, can be programmed to vibrate for sound detected
originating from the user's left side. Similarly, a second
transducer located, e.g., on a user's right tooth, can be
programmed to vibrate for sound detected originating from the
user's right side. Other variations and queues may be utilized as
these examples are intended to be illustrative of potential
variations.
[0109] In variations where the one or more microphones are
positioned in intra-buccal locations, the microphone may be
integrated directly into the electronics and/or transducer
assembly, as described above. However, in additional variation, the
microphone unit may be positioned at a distance from the transducer
assemblies to minimize feedback. In one example, similar to a
variation shown above, microphone unit 282 may be separated from
electronics and/or transducer assembly 280, as shown in FIGS. 27A
and 27B. In such a variation, the microphone unit 282 positioned
upon or adjacent to the gingival surface 268 may be electrically
connected via wire(s) 264.
[0110] Although the variation illustrates the microphone unit 282
placed adjacent to the gingival tissue 268, unit 282 may be
positioned upon another tooth or another location within the mouth.
For instance, FIG. 28 illustrates another variation 290 which
utilizes an arch 19 connecting one or more tooth retaining portions
21, 23, as described above. However, in this variation, the
microphone unit 294 may be integrated within or upon the arch 19
separated from the transducer assembly 292. One or more wires 296
routed through arch 19 may electrically connect the microphone unit
294 to the assembly 292. Alternatively, rather than utilizing a
wire 296, microphone unit 294 and assembly 292 may be wirelessly
coupled to one another, as described above.
[0111] In yet another variation for separating the microphone from
the transducer assembly. FIG. 29 illustrates another variation
where at least one microphone 302 (or optionally any number of
additional microphones 304, 306) may be positioned within the mouth
of the user while physically separated from the electronics and/or
transducer assembly 300. In this manner, the one or optionally more
microphones 302, 304, 306 may be wirelessly coupled to the
electronics and/or transducer assembly 300 in a manner which
attenuates or eliminates feedback, if present, from the
transducer.
[0112] The applications of the devices and methods discussed above
are not limited to the treatment of hearing loss but may include
any number of further treatment applications. Moreover, such
devices and methods may be applied to other treatment sites within
the body. Modification of the above-described assemblies and
methods for carrying out the invention, combinations between
different variations as practicable, and variations of aspects of
the invention that are obvious to those of skill in the art are
intended to be within the scope of the claims.
* * * * *