U.S. patent application number 17/190830 was filed with the patent office on 2021-06-24 for drug delivery customized ear canal apparatus.
The applicant listed for this patent is Earlens Corporation. Invention is credited to Brent EDWARDS, William FACTEAU, Rodney PERKINS, Lakshman RATHNAM, Paul RUCKER, Kulbir SANDHU, Cem SHAQUER.
Application Number | 20210186343 17/190830 |
Document ID | / |
Family ID | 1000005433016 |
Filed Date | 2021-06-24 |
United States Patent
Application |
20210186343 |
Kind Code |
A1 |
PERKINS; Rodney ; et
al. |
June 24, 2021 |
DRUG DELIVERY CUSTOMIZED EAR CANAL APPARATUS
Abstract
The present invention is directed to a wearable system wherein
elements of the system, including various sensors adapted to detect
biometric and other data and/or to deliver drugs, are positioned
proximal to, on or in the ear canal of a person. In embodiments of
the invention, elements of the system, including drug delivery
devices, are positioned on or in the ear canal for extended periods
of time. For example, an element of the system may be positioned on
the tympanic membrane of a user and left there overnight, for
multiple days, months, or years. Because of the position and
longevity of the system elements in the ear canal, the present
invention has many advantages over prior wearable biometric and
drug delivery devices.
Inventors: |
PERKINS; Rodney; (Woodside,
CA) ; FACTEAU; William; (Atherton, CA) ;
EDWARDS; Brent; (San Francisco, CA) ; RUCKER;
Paul; (San Francisco, CA) ; SANDHU; Kulbir;
(Fremont, CA) ; SHAQUER; Cem; (Saratoga, CA)
; RATHNAM; Lakshman; (Mountain View, CA) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Earlens Corporation |
Menlo Park |
CA |
US |
|
|
Family ID: |
1000005433016 |
Appl. No.: |
17/190830 |
Filed: |
March 3, 2021 |
Related U.S. Patent Documents
|
|
|
|
|
|
Application
Number |
Filing Date |
Patent Number |
|
|
15282809 |
Sep 30, 2016 |
|
|
|
17190830 |
|
|
|
|
62236295 |
Oct 2, 2015 |
|
|
|
62395667 |
Sep 16, 2016 |
|
|
|
Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61M 31/00 20130101;
H04R 2460/07 20130101; A61B 5/024 20130101; A61B 5/0816 20130101;
H04R 2225/025 20130101; A61B 5/4818 20130101; A61B 5/4866 20130101;
A61B 5/25 20210101; A61B 5/14542 20130101; A61B 5/112 20130101;
H04R 25/70 20130101; A61N 1/36038 20170801; A61B 5/6815 20130101;
A61B 5/4094 20130101; A61B 5/14539 20130101; A61N 1/36036 20170801;
A61B 5/4815 20130101; A61B 5/1118 20130101; A61B 5/6817 20130101;
A61B 5/1112 20130101; A61M 2210/0662 20130101; H04R 25/00 20130101;
A61B 5/4266 20130101; A61B 5/14517 20130101; A61B 5/389 20210101;
A61B 5/0059 20130101; A61M 31/002 20130101; A61B 5/021 20130101;
A61B 5/296 20210101; A61B 5/14532 20130101; A61B 5/369 20210101;
A61N 1/306 20130101; A61B 5/4839 20130101; A61B 5/291 20210101;
A61N 1/0541 20130101; A61M 2037/0023 20130101; A61B 5/14552
20130101; H04R 2225/55 20130101; H04R 25/02 20130101; A61B 5/349
20210101; A61B 5/026 20130101; H04R 1/028 20130101; H04R 2225/023
20130101; A61B 5/1451 20130101; A61B 5/6816 20130101; A61B 5/4875
20130101; A61B 5/02055 20130101 |
International
Class: |
A61B 5/0205 20060101
A61B005/0205; A61B 5/00 20060101 A61B005/00; H04R 1/02 20060101
H04R001/02; H04R 25/00 20060101 H04R025/00; A61M 31/00 20060101
A61M031/00; A61B 5/25 20060101 A61B005/25; A61B 5/291 20060101
A61B005/291; A61B 5/296 20060101 A61B005/296; A61B 5/349 20060101
A61B005/349; A61B 5/369 20060101 A61B005/369; A61B 5/389 20060101
A61B005/389; A61N 1/05 20060101 A61N001/05; A61N 1/36 20060101
A61N001/36; A61B 5/026 20060101 A61B005/026; A61B 5/11 20060101
A61B005/11; A61B 5/145 20060101 A61B005/145; A61B 5/1455 20060101
A61B005/1455; A61N 1/30 20060101 A61N001/30; H04R 25/02 20060101
H04R025/02 |
Claims
1. An ear canal platform comprising: a medial ear canal assembly
adapted to be positioned on the tympanic membrane of a user, the
medial ear canal assembly comprising a retention structure adapted
to conform to the anatomy of the user's ear canal, wherein the
retention structure includes a first end corresponding to a shape
profile of the anterior sulcus and the anterior portion of the
tympanic membrane annulus; and a drug delivery device mounted on
the ear canal assembly.
2. An ear canal platform according to claim 1, further including
sensors connected to the ear canal assembly, the sensors being
connected to a transmitter.
3. An ear canal platform according to claim 2, wherein the sensors
include sensors adapted to detect biometric data.
4. An ear canal platform according to claim 3, wherein the sensors
include sensors adapted to detect one or more physical
characteristics of the user.
5. An ear canal platform according to claim 2, wherein at least one
of the sensors is a microphone.
6. An ear canal platform according to claim 5, wherein the
microphone is a micro-actuator.
7. An ear canal platform according to claim 6, wherein sound
received by the micro-actuator is converted to a transmitted
signal.
8. An ear canal platform according to claim 7, wherein the ear
canal platform includes a data processor which converts the
transmitted signal to a signal representative of the sound received
by the micro-actuator.
9. An ear canal platform according to claim 8, wherein the signal
is transmitted by a hearing system to a receiver external to the
hearing system.
10. An ear canal platform according to claim 9, wherein the
receiver is a smart phone, a wireless network, or a peripheral
device.
11. An ear canal platform according to claim 2, wherein at least
one of the sensors comprises a skin contacting sensor or a non-skin
contacting sensor.
12. An ear canal platform according to claim 2, wherein at least
one of the sensors comprises an umbo sensor, an eartip sensor, or a
tethered sensor.
13. A method of delivering drugs to a user having a medial ear
canal assembly positioned on the user's tympanic membrane, the
medial ear canal assembly comprising a drug delivery device and a
retention structure adapted to conform to the anatomy of the user's
ear canal, wherein the retention structure includes a first end
corresponding to a shape profile of the anterior sulcus and the
anterior portion of the tympanic membrane annulus, the method
comprising the steps of: delivering drugs to the user through the
drug delivery device.
14. A method according to claim 13, wherein the medial ear canal
assembly further includes sensors and a transmitter, the method
comprising the steps of: using the sensors to measure biometric
data of the user; and transmitting the measured biometric data
using the transmitter.
15. A method according to claim 14, further including the step of
activating the drug delivery device using the biometric data
measured by the sensors.
16. A method according to claim 14, the method further comprising
using the sensors to measure one or more physical characteristics
of the user.
17. A method according to claim 15, further comprising the step of
activating the drug delivery device using the measured physical
characteristics of the user.
18. A method according to claim 14, wherein at least one of the
sensors comprises a skin contacting sensor or a non-skin contacting
sensor.
19. A method according to claim 14, wherein at least one of the
sensors comprises an umbo sensor, an eartip sensor, or a tethered
sensor.
Description
CROSS REFERENCE TO RELATED APPLICATIONS
[0001] This application is a continuation of U.S. patent
application Ser. No. 15/282,809, filed Sep. 30, 2019; which claims
the benefit of U.S. Provisional Application Nos. 62/236,295, filed
Oct. 2, 2015; and 62/395,667, filed Sep. 16, 2016; which are
incorporated herein by reference in their entirety.
BACKGROUND OF THE INVENTION
[0002] The present invention is related to wearable devices and
methods for their use. The present invention is further related to
hearing devices. The present invention is further related to drug
delivery devices. The present invention is further related to
methods for the use of wearable devices, hearing devices and drug
delivery devices.
SUMMARY OF THE INVENTION
[0003] The present invention is directed to a wearable system
wherein elements of the system, including various sensors, are
adapted to detect biometric and other data and/or to deliver drugs.
In this invention, the elements of the system are positioned
proximal to, on, or in the ear canal of a person. In embodiments of
the invention, elements of the system are positioned external to,
on or in the ear canal and may reside there for extended periods of
time. For example, an element of the system, including drug
delivery devices, may be positioned on the tympanic membrane of a
user and left there overnight, for multiple days, months or years.
Because of the position and longevity of the system elements in the
ear canal, the present invention has many advantages over prior
drug delivery devices.
BRIEF DESCRIPTION OF THE DRAWINGS
[0004] The foregoing and other objects, features and advantages of
embodiments of the present inventive concepts will be apparent from
the more particular description of preferred embodiments, as
illustrated in the accompanying drawings in which like reference
characters refer to the same or like elements. The drawings are not
necessarily to scale; emphasis instead being placed upon
illustrating the principles of the preferred embodiments.
[0005] FIG. 1 shows a hearing system configured in accordance with
embodiments of the present invention.
[0006] FIG. 2 shows an isometric view of the medial ear canal
assembly of the hearing system of FIG. 1 in accordance with
embodiments of the present invention.
[0007] FIG. 3 shows a top view of the medial ear canal assembly of
the hearing system of FIG. 1 in accordance with embodiments of the
present invention.
[0008] FIG. 4 shows an exploded view of a medial ear canal assembly
and its method of assembly, in accordance with embodiments of the
present invention.
[0009] FIG. 5A is an isometric Top view of a medial ear canal
assembly in accordance with embodiments of the present
invention.
[0010] FIG. 5B is an isometric bottom view of a medial ear canal
assembly in accordance with embodiments of the present
invention.
[0011] FIG. 6 shows a medial ear canal assembly in accordance with
embodiments of the present invention.
[0012] FIG. 7 shows an isometric view of a medial ear canal
assembly including a drug delivery reservoir in accordance with
embodiments of the present invention.
[0013] FIG. 7A is a side view of a medial ear canal assembly
including drug delivery system according to one embodiment of the
invention.
[0014] FIG. 8 shows an isometric view of a lateral ear canal
assembly in accordance with embodiments of the present
invention.
[0015] FIG. 9 is an isometric top view of a medial ear canal
assembly in accordance with embodiments of the present
invention.
[0016] FIG. 10 is an isometric bottom view of a medial ear canal
assembly in accordance with embodiments of the present
invention.
DETAILED DESCRIPTION OF THE INVENTION
Advantages
[0017] In embodiments of the present invention, biometric sensors
and other devices may be placed in proximity to, on or in the ear
canal resulting in a system with the ability to collect information
on the user's environment, including information on the user's
location, the time of day, and the activity the user is engaged in.
In embodiments of the present invention, drug delivery devices may
be placed in proximity to, on or in the ear canal resulting in a
system with the ability to deliver drugs to a user through the ear
and/or components of the ear. In embodiments of the present
invention, the combination of a superior hearing system with
biometric sensors and other devices, such as drug delivery devices,
in a single system which may be placed in proximity to, on or in
the ear canal may result in a system with the ability to collect
information on the user's environment, including information on the
user's location, the time of day, and the activity the user is
engaged in. The system may further provide access to highly
vascular sections of ear canal, including the pars tensa and
manubrium vessels and the information that may be gathered from
such locations.
[0018] The system may further provide the ability to gather data,
monitor health, send alerts and deliver drugs through a device that
is in place 24 hours a day for years on end, without interfering
with or changing the wearer's day to day activities. The system may
further provide the ability to ensure user compliance without the
need for user interaction, other than, in some cases, normal
upkeep. In some embodiments, the current invention may be used to
replace halter monitors, event recorders and/or Sub-Cutaneous
(Sub-Q) monitors (e.g. injectable monitors). The system may further
provide the ability to mount sensors directly against the skin and
ensure that they stay in place over long periods of time, by, for
example, using system components that are custom fit to the ear
canal wall and/or to the tympanic membrane. The system may further
provide the user with feedback, instructions or warnings which go
directly to the wearer's tympanic membrane in a manner which is
imperceptible to any third party.
[0019] A system according to the present invention may further
enable a user to take advantage of characteristics of the ear canal
of the user to make measurements of the user's biometric data,
including: positioning of sensors in a place, which is undetectable
to both the user and third parties; positioning of sensors in a
place where they are well protected from the environment, and from
external forces (not subject to false alarms, such as, for example,
the type of false alarms that result from the dropping or shaking
of externally worn devices); positioning of sensors in a very
vascular environment; positioning sensors in an environment which
may be highly conducive to the measurement of biometric data (an
environment where a better signal to noise ratio is
achievable--enclosed and dark to facilitate optical measurements;
and positioning sensors in an environment where an extensive range
of biometric data is available and can be measured, including blood
pressure, heart rate, glucose levels, respiration rate,
temperature, blood flow and other biometric data.
[0020] A system according to the present invention may further
provide: the ability to deliver drugs to a user, including
sustained, timed and/or algorithm controlled drug delivery; the
ability to ensure compliance with drug regimens by automating drug
delivery in an easily accessible region such as the ear canal; the
ability to limit the amount of drug delivered without compromising
efficacy by delivering to highly vascular tissue in or around the
ear canal, such as, for example, the pars tensa and manubrium
vessels; the ability to deliver drugs to regions of the body where
the vasculature is easily accessible, for example, where the tissue
covering the vasculature is very thin, such as, for example, over
the manubrium vessels; the ability to locally deliver drugs which
are normally delivered systemically, thereby reducing the amount of
drugs delivered and the related side effects; and the ability to
deliver drugs and treat diseases using a novel platform in the ear
canal. Drugs which may be delivered using the present invention
include antibiotics (neomycin/quinolenes), dexamethasone, steroids
(prednisolone), acetic acid, aluminum acetate, boric acid,
betnesol, prednisolone sodium phosphate, clotrimazole,
Ceruminolytic agents (sodium
chloride/chlorbutanol/paradichlorobenzene), amoxicillin,
flucloxacillin; ciprofloxacillin, penicillin, betahistine dopamine
antagonists (prochlorperazine), antihistamines (cinnarizine and
cyclizine), antiviral drugs (acyclovir), sodium fluoride, nicotine
and insulin. Diseases which may be treated using the present
invention include acute otitis media, furunculosis of external
auditory canal, perichondritis of pinna, acute mastoiditis, and
malignant otitis externa, vertigo, herpes zoster oticus and cancer.
Embodiments of the invention may be used to deliver drugs in which
systemic or local drug delivery would be beneficial.
[0021] FIG. 1 shows a hearing system 10 configured to transmit
electromagnetic energy EM to a medial ear canal assembly 100
positioned in the ear canal EC of the user. The ear comprises an
external ear, a middle ear ME and an inner ear. The external ear
comprises a Pinna P and an ear canal EC and is bounded medially by
a tympanic membrane (also referred to as an eardrum) TM. Ear canal
EC extends medially from pinna P to tympanic membrane TM. Ear canal
EC is at least partially defined by a skin SK disposed along the
surface of the ear canal. The tympanic membrane TM comprises a
tympanic membrane annulus TMA that extends circumferentially around
a majority of the eardrum to hold the eardrum in place. The middle
ear ME is disposed between tympanic membrane TM of the ear and a
cochlea CO of the ear. The middle ear ME comprises the ossicles OS
to couple the tympanic membrane TM to cochlea CO. The ossicles OS
comprise an incus IN, a malleus ML and a stapes ST. The malleus ML
is connected to the tympanic membrane TM and the stapes ST is
connected to an oval window OW, with the incus IN disposed between
the malleus ML and stapes ST. Stapes ST is coupled to the oval
window OW so as to conduct sound from the middle ear to the
cochlea.
[0022] The hearing system 10 may include an input transducer
assembly 20 and a medial ear canal assembly 100 to transmit sound
to the user. Hearing system 10 may comprise a sound processor 24,
which may be, for example, a behind the ear unit (BTE). Sound
processor 24 may comprise many components of hearing system 10 such
as a speech processor, battery, wireless transmission circuitry,
and input transducer assembly 20. The input transducer assembly 20
can be located at least partially behind the pinna P or
substantially or entirely within the ear canal EC. Input transducer
assembly 20 may further comprise a Bluetooth.TM. connection to
couple to a cell phone or other external communication device 26.
The medial ear canal assembly 100 of hearing system 10 may comprise
components to receive the light energy or other energy, such as RF
energy and vibrate the eardrum in response to such energy.
[0023] The input transducer assembly 20 can receive a sound input,
for example an audio sound or an input from external communication
device 26. With hearing aids for hearing impaired individuals, the
input can be ambient sound. The input transducer assembly may
comprise at least one input transducer, for example a microphone
22. The at least one input transducer may comprise a second
microphone located away from the first microphone, in the ear canal
or the ear canal opening, for example positioned on sound processor
24. Input transducer assembly 20 may also include can include a
suitable amplifier or other electronic interface. In some
embodiments, the input may comprise an electronic sound signal from
a sound producing or receiving device, such as a telephone, a
cellular telephone, a Bluetooth connection, a radio, a digital
audio unit, and the like.
[0024] Input transducer assembly 20 may include a lateral ear canal
assembly 12 which may comprise a light source such as an LED or a
laser diode for transmitting data (including audio data) and energy
to medial ear canal assembly 100. In other embodiments, lateral ear
canal assembly 12 may comprise an electromagnetic coil, an RF
source, or the like for transmitting data (including audio data)
and energy to medial ear canal assembly 100. In embodiments of the
invention, lateral ear canal assembly 12 may further comprise a
receiver adapted to receive data transmitted from medial ear canal
assembly 100, such as, for example, biometric data from sensors
positioned on or near medial ear canal assembly 100.
[0025] In embodiments of the invention, medial ear canal assembly
100 is adapted to receive the output from input transducer assembly
20 and produce mechanical vibrations in response to the received
information, which may be, for example, in the form of a light
signal generated by lateral ear canal assembly 12. In embodiments
of the invention, medial ear canal assembly 100 comprises a sound
transducer, wherein the sound transducer may comprise at least one
of a microactuator, a coil, a magnet, a magnetostrictive element, a
photostrictive element, or a piezoelectric element. In embodiments
of the invention, input transducer assembly 20 may comprise a light
source coupled to sound processor 24 by a fiber optic cable and
positioned on lateral ear canal assembly 12. In embodiments of the
invention, input transducer assembly 20 may comprise a laser diode
coupled to sound processor 24 and positioned on lateral ear canal
assembly 12. In embodiments of the invention, the light source of
the input transducer assembly 20 may be positioned in the ear canal
along with sound processor 24 and microphone 22. When properly
coupled to the subject's hearing transduction pathway, the
mechanical vibrations caused by medial ear canal assembly 100 can
stimulate the cochlea CO, which induces neural impulses in the
subject which can be interpreted by the subject as a sound
input.
[0026] FIG. 2 and FIG. 3 show isometric and top views,
respectively, of an embodiment of medial ear canal assembly 100
according to the present invention. In the illustrated embodiments,
medial ear canal assembly 100 may comprise a retention structure
110, a support structure 120, a transducer 130, at least one spring
140, and a photodetector 150. Medial ear canal assembly 100 may
include data processor 200 and transmitter 210 which may be
positioned on transducer 130. Retention structure 110, which may be
a resilient retention structure, may be sized to couple to the
tympanic membrane annulus TMA and at least a portion of the
anterior sulcus AS of the ear canal EC. Retention structure 110 may
comprise an aperture 110A. Aperture 110A is sized to receive
transducer 130 and to allow for normal transduction of sound
through the subjects hearing transduction pathway.
[0027] The retention structure 110 can be sized to the user and may
comprise one or more of an O-ring, a C-ring, a molded structure, or
a structure having a shape profile so as to correspond to the
user's ear canal anatomy, or to a mold of the ear canal of the
user. Retention structure 110 may comprise a resilient retention
structure such that the retention structure can be compressed
radially inward as indicated by arrows 102 from an expanded wide
profile configuration to a narrow profile configuration when
passing through the ear canal and subsequently expand to the wide
profile configuration when placed on one or more of the eardrum,
the eardrum annulus, or the skin of the ear canal. The retention
structure 110 may comprise a shape profile corresponding to
anatomical structures that define the ear canal. For example, the
retention structure 110 may comprise a first end 112 corresponding
to a shape profile of the anterior sulcus AS of the ear canal and
the anterior portion of the tympanic membrane annulus TMA. The
first end 112 may comprise an end portion having a convex shape
profile, for example a nose, so as to fit the anterior sulcus and
so as to facilitate advancement of the first end 112 into the
anterior sulcus. The retention structure 110 may comprise a second
end 114 having a shape profile corresponding to the posterior
portion of tympanic membrane annulus TMA.
[0028] The support structure 120 may be positioned in aperture 110A
and may comprise a frame, or chassis, so as to support the
components connected to support structure 120. Support structure
120 may comprise a rigid material and can be coupled to the
retention structure 110, the transducer 130, the at least one
spring 140, which may support transducer 130, and the photodetector
150. The support structure 120 may comprise an elastomeric bumpers
122 extending between the support and the retention structure, so
as to couple the support to the retention structure 110 with the
elastomeric bumpers 122. The support structure 120 may define an
aperture 120A formed thereon. The aperture 120A can be sized so as
to receive transducer 130, which may be, for example, a balanced
armature transducer. When positioned in aperture 120A, housing 139
of the balanced armature transducer 130 may extend at least
partially through the aperture 120A when transducer 130 is coupled
to the tympanic membrane TM. Aperture 120A may be further sized to
allow normal sound conduction through medial ear canal assembly
100.
[0029] Transducer 130 may, in embodiments of the invention,
comprise structures to couple to the eardrum when the retention
structure 110 contacts one or more of the eardrum, the eardrum
annulus, or the skin of the ear canal. The transducer 130 may, in
embodiments of the invention, comprise a balanced armature
transducer having a housing 139 and a vibratory reed 132 extending
out one end of housing 139. Housing 139 may also, in embodiments of
the invention, be a part of a flux return path for transducer 130.
In embodiments of the invention, the housing may be a fully
integrated part of the transducer, including, for example, the
magnetic flux path. The vibratory reed 132 may be affixed to a post
134 and an umbo pad 136. The umbo pad 136 may have a convex surface
that contacts the tympanic membrane TM and may move the TM in
response to signals received by medial ear canal assembly 100,
causing the TM to vibrate. The umbo pad 136 can be anatomically
customized to the anatomy of the ear of the user.
[0030] At least one spring 140 may be connected to the support
structure 120 and the transducer 130, so as to support the
transducer 130 in aperture 120A. The at least one spring 140 may
comprise a first spring 142 and a second spring 144, in which each
spring is connected to opposing sides of a first end of transducer
130. The springs may comprise coil springs having a first end
attached to support structure 120 and a second end attached to
transducer 130 or a mount affixed to transducer 130, such that the
coil springs pivot the transducer about axes 140A of the coils of
the coil springs and resiliently urge the transducer toward the
eardrum when retention structure 110 contacts one or more of the
eardrum, the eardrum annulus, or the skin of the ear canal. The
support structure 120 may comprise a tube sized to receiving an end
of the at least one spring 140, so as to couple the at least one
spring to support structure 120.
[0031] In embodiments of the invention, a photodetector 150 may be
coupled to support structure 120 of medial ear canal assembly 100.
A bracket mount 152 can extend substantially around photodetector
150. An arm 154 may extend between support structure 120 and
bracket mount 152 so as to support photodetector 150 with an
orientation relative to support structure 120 when placed in the
ear canal EC. The arm 154 may comprise a ball portion so as to
couple to support structure 120 with a ball joint 128. The
photodetector 150 may be electrically coupled to transducer 130 so
as to drive transducer 130 with electrical energy in response to
the light energy signal radiated to medial ear canal assembly 100
by input transducer assembly 20. In embodiments of the invention,
medial ear canal assembly 100 may include an electronics package
215 mounted on a back surface of photodetector 150. Electronics in
electronics package 215 may be used to, for example, condition or
modulate the light energy signal between photodetector 150 and
transducer 130. Electronics package 215 may comprise, for example,
an amplifier to amplify the signal from photodetector 150.
[0032] Resilient retention structure 110 can be resiliently
deformed when inserted into the ear canal EC. The retention
structure 110 can be compressed radially inward along the pivot
axes 140A of the coil springs such that the retention structure 110
is compressed as indicated by arrows 102 from a wide profile
configuration having a first width 110W1 as illustrated in FIG. 3
to an elongate narrow profile configuration having a second width
110W2. Compression of retention structure 110 may facilitate
advancement of medial ear canal assembly 12 through ear canal EC in
the direction illustrate by arrow 104 in FIG. 2 and when removed
from the ear canal in the direction illustrated by arrow 106 in
FIG. 2. The elongate narrow profile configuration may comprise an
elongate dimension extending along an elongate axis corresponding
to an elongate dimension of support structure 120 (120W) and
aperture 120A. The elongate narrow profile configuration may
comprise a shorter dimension corresponding to a width of the
support structure 120 and aperture 120A. The retention structure
110 and support structure 120 may be passed through the ear canal
EC for placement on, for example, the tympanic membrane TM of a
user. To facilitate placement, vibratory reed 132 of the transducer
130 can be aligned substantially with the ear canal EC while medial
ear canal assembly 100 is advanced along the ear canal EC in the
elongate narrow profile configuration having second width
110W2.
[0033] When properly positioned, retention structure 110 may return
to a shape conforming to the ear canal adjacent to tympanic
membrane TM, wherein the medial ear canal assembly is held in
place, at least in part, by the interaction of retention structure
110 with the walls of ear canal EC. The medial ear canal assembly
100, including support structure 120, may apply a predetermined
amount of force to the tympanic membrane TM when the umbo pad 136
is in contact with the eardrum. When medial ear canal assembly 100
is positioned the support structure 120 can maintain a
substantially fixed shape and contact with the tympanic membrane TM
is maintained, at least in part, by the force exerted by at least
one spring 140.
[0034] FIG. 4 is an exploded view of a medial ear canal assembly
100 according to embodiments of the present invention which shows
an assembly drawing and a method of assembling medial ear canal
assembly 100. The retention structure 110 as described herein can
be coupled to the support structure 120, for example, with
elastomeric bumpers 122 extending between the retention structure
110 and the support structure 120. The retention structure 110 may
define an aperture 110A having a width 110AW corresponding to the
wide profile configuration. The support structure 120 may define an
aperture 120A having a width 120AW that remains substantially fixed
when the resilient retention structure is compressed. The aperture
110A of the resilient retention structure can be aligned with the
aperture 120A of the support. Support structure 120 may comprise
ball joint 128, and ball joint 128 can be coupled to arm 154 and
bracket mount 152, such that the support is coupled to the
photodetector 150.
[0035] The transducer 130 may comprise a housing 139 and a mount
138 attached to housing 139, in which the mount 138 is shaped to
receive the at least one spring 140. The transducer 130 may
comprise a vibratory reed 132 extending from housing 139, in which
the vibratory reed 132 is attached to a post 134. The post 134 can
be connected to the umbo pad 136.
[0036] The support structure 120 can be coupled to the transducer
130 with the at least one spring 140 extending between the coil and
the transducer such that the umbo pad 136 is urged against the
tympanic membrane TM when the medial ear canal assembly 100 is
placed to transmit sound to the user. The support structure 120 may
comprise mounts 126, for example tubes, and the mounts 126 can be
coupled to a first end of the at least one spring 140, and a second
end of the at least one spring 140 can be coupled to the transducer
130 such that the at least one spring 140 extends between the
support and the transducer. Umbo sensor 220 may be attached to umbo
pad 136 such that umbo sensor 220 is positioned against tympanic
membrane TM when medial ear canal assembly 100 is positioned in the
ear canal. Umbo sensor may be positioned against any portion of the
tympanic membrane and may be referred to as a tympanic membrane
sensor.
[0037] FIG. 5A is an isometric top view of a medial ear canal
assembly 100 according to embodiments of the invention. FIG. 5B is
an isometric bottom view of a medial ear canal assembly 100
according to embodiments of the invention. In FIGS. 5A and 5B,
medial ear canal assembly 100 has a retention structure 110
comprising a stiff support 121 extending along a portion of
retention structure 110. The stiff support 121 may be connected to
resilient member 141 and coupled to intermediate portion 149. In
many embodiments, resilient member 141 and stiff support structure
120 comprise an integrated component such as an injection molded
(or 3-D Printed) unitary component comprising a modulus of
elasticity and dimensions so as to provide the resilient member 141
and the stiff support 121.
[0038] In the embodiments of FIG. 5A and 5B, stiff support 121 and
resilient member 141 can be configured to support output transducer
130 such that output transducer 130 is coupled to the tympanic
membrane TM when the medial ear canal assembly 100, including
retention structure 110 is placed in the ear canal EC. The
resilient member 141 can be attached to the stiff support 121, such
that the resilient member 141 directly engages the stiff support
121. The stiff support 121 can be affixed to the resilient member
141 so as to position the umbo pad 136 below the retention
structure 110, such that the umbo pad 136 engages the tympanic
membrane TM when the retention structure 110 is placed, for example
on the tympanic membrane annulus TMA. The resilient member 141 can
be configured to provide a predetermined force to the eardrum when
the medial ear canal assembly 100 is placed in the Ear Canal.
[0039] In the embodiments of FIGS. 5A and 5B, resilient member 141
may comprise a resilient cantilever beam. In these embodiments,
photodetector 150 may be attached to the output transducer 130 with
a mount 153. Photodetector 150 and output transducer 130 can
deflect together when the biasing structure 149, for example a
spacer, is adjusted to couple the output transducer 130 and the
umbo pad 136 to the tympanic membrane TM.
[0040] Sulcus sensors 230 may be positioned on layer 115 of
retention structure 110 such that sulcus sensors 230 are in contact
with the tympanic membrane TM and/or other portions of the ear
canal EC when medial ear canal assembly 100 is positioned in the
ear canal. Sulcus sensors 230 may also be positioned on sulcus
flanges 235 to optimize their position in ear canal EC, such as,
for example, to optimize their position against the tissue of
tympanic membrane TM and/or against the tissue of the tympanic
membrane annulus TMA. Sulcus flanges 235 may be used to, for
example, position sulcus sensors 230 over regions of highly
vascular tissue in the ear canal EC, such as on the tympanic
membrane TM. Sulcus flanges 235 may be used to, for example,
position sulcus sensors 230 over the pars tensa.
[0041] FIG. 6 shows an isometric view of the medial ear canal
assembly 100. Medial ear canal assembly 100 comprises a retention
structure 110, a support structure 120, a transducer 130, at least
one spring 140 and a photodetector 150. Medial ear canal assembly
100 may include data processor 200 and transmitter 210 which may be
positioned on transducer 130. Medial ear canal assembly 100 may
further include non-contact sensors 260 and tethered sensors 250.
Non-contact sensors 260 and tethered sensors 250 may be connected
to data processor 200 to provide data to data processor 200.
Alternatively, or in combination, one or more of data processor
200, transmitter 210, non-contact sensor(s) 260 and tethered
sensors 250 may be part of, located on, or connected to electronics
package 215 on photodetector 150. Tethered sensors 250 may be
positioned against the skin SK in the ear canal EC where umbo
sensors 220 (not shown in FIG. 6) and sulcus sensors 230 (not shown
in FIG. 6) cannot contact. Alternatively or in combination, one or
more of non-contact sensors 260 may be positioned loosely in ear
canal EC to gather data. Retention structure 110 is sized to couple
to the tympanic membrane annulus TMA and at least a portion of the
anterior sulcus AS of the ear canal EC. With respect to the
remaining elements of the retention structure and their function,
see the discussion of FIGS. 2 and 3.
[0042] FIG. 7 shows and isometric view of the medial ear canal
assembly 100 including retention structure 110, support structure
120, springs 140, a photodetector 150, and at least one drug
delivery device. In embodiments of the invention, medial ear canal
assembly 100 may include reservoir 400 and delivery tube 410 which
are adapted to deliver drugs to the wearer. In embodiments of the
invention, reservoir 400 may be used to store drugs for delivery
to, for example, the tympanic membrane. In embodiments of the
invention, delivery tube 410 may be used to transport drugs from
reservoir 400 to umbo pad 136 which may be constructed to transmit
the drugs to or through at least a portion of the tympanic membrane
TM. In embodiments of the invention, umbo pad 136 may be
constructed to include, for example, microneedles through which
drugs may be transported into the tissue of, for example, the
tympanic membrane.
[0043] In embodiments of the invention, the medial ear canal
assembly 100 may include sensors, such as, for example, umbo
sensors 220, sulcus sensors 230 and tethered sensors 250, such as
those shown in FIGS. 4, 5, and 6. In embodiments of the invention,
sensors located on medial ear canal assembly 100 may be used to
collect data on the user, which user data may be used to regulate
the flow of drugs from the at least one drug delivery device which
is incorporated into medial ear canal assembly 100. In embodiments
of the invention, the drug delivery device on medial ear canal
assembly 100 may include power supply 426 adapted to provide power
to medial ear canal assembly 100, including pump 424.
[0044] FIG. 7A is an isometric view of the medial ear canal
assembly 100 including retention structure 110, a photodetector
150, and at least one drug delivery device. In embodiments of the
invention, medial ear canal assembly 100 may include reservoir (not
shown) and delivery tube 410 which are adapted to deliver drugs to
the wearer. In embodiments of the invention, the reservoir may be
used to store drugs for delivery to, for example, the tympanic
membrane or the region surrounding the tympanic membrane. In
embodiments of the invention, delivery tube 410 may be used to
transport drugs from the reservoir to umbo pad 136 which may be
constructed to transmit the drugs to or through at least a portion
of the tympanic membrane TM. In embodiments of the invention, umbo
pad 136 may be constructed to include, for example, microneedles
422 through which drugs may be transported into the tissue of, for
example, the tympanic membrane. In embodiments of the invention,
umbo pad 136 may be constructed to include, for example, needles
420 through which drugs may be transported into the tissue of, for
example, the tympanic membrane. In embodiments of the invention,
retention structure 110 may be constructed to include, for example,
microneedles 422 through which drugs may be transported into the
tissue of, for example, the tympanic membrane. In embodiments of
the invention, the drug delivery device on medial ear canal
assembly 100 may include pump 424 adapted to pump drugs from the
reservoir to microneedles 422. In embodiments of the invention, the
drug delivery device on medial ear canal assembly 100 may include
pump 424 adapted to pump drugs from the reservoir to needle 420. In
embodiments of the invention, the drug delivery device on medial
ear canal assembly 100 may include power supply 426 adapted to
provide power to medial ear canal assembly 100, including pump
424.
[0045] FIG. 8 shows a lateral ear canal assembly 12, including a
retention structure 310 (which may also be referred to as an eartip
retention structure) configured for placement in the ear canal.
Retention structure 310 may comprise a molded tubular structure
having the shape of the ear canal. Retention structure 310 may be
configured to retain lateral ear canal assembly 12 in the ear
canal. Lateral ear canal assembly 12 may include a signal source
320 such as a laser diode. An outer surface 340 of retention
structure 310 may include ear tip sensors 240, which may be
positioned against the skin SK of the ear canal EC and,
alternatively or in combination, sensors (not shown) which are
positioned on the medial or lateral ends of lateral ear canal
assembly 12, such as, for example, a body temperature sensor.
[0046] FIG. 9 is an isometric Top view of a medial ear canal
assembly in accordance with embodiments of the present invention.
In FIG. 9, medial ear canal assembly 100 comprises transducer 130,
photodetector 150, spring 140, support structure 120 and retention
structure 110. In the embodiment of FIG. 9, sulcus sensors 230 may
be positioned on retention structure 110, which may be, for example
a flexible material adapted to conform to the anatomy of the user's
ear canal. Retention structure 110 may comprise a material such as
Parylene or Silicone.
[0047] FIG. 10 is an isometric bottom view of a medial ear canal
assembly in accordance with embodiments of the present invention.
In FIG. 10, medial ear canal assembly 100 may comprise transducer
130, photodetector 150, spring 140, support structure 120,
retention structure 110 and umbo pad 136. In the embodiment of FIG.
10, sulcus sensors 230 may be positioned on retention structure
110, which may be, for example a flexible material adapted to
conform to the anatomy of the user's ear canal. In the embodiment
of FIG. 10, umbo sensors 220 may be positioned on umbo pad 136.
Retention structure 110 may comprise a material such as Parylene or
Silicone.
[0048] In embodiments of the invention, umbo sensors 220, sulcus
sensors 230, eartip sensors 240, and tethered sensors 250 may
comprise sensors that contact the skin to detect biometric data.
Alternatively, or in combination, umbo sensors 220, sulcus sensors
230, eartip sensors 240, and tethered sensors 250 may comprise
sensors that do not require skin contact to detect biometric data.
Non-contact sensors may also be sensors which do not require skin
contact to detect biometric data.
[0049] Skin contacting sensors adaptable for use in embodiments of
the present invention may include: micro-sensors, electrochemical
sensors; thin film sensors; pressure sensors; micro-needle sensors,
capacitive sensors thermometers, thermocouples, trigeminal nerve
monitors; piezoelectric sensors; electrodes, pulse oximetry
sensors, glucose meters, oxygen sensors and iontophoresis
electrodes.
[0050] Non-skin contacting sensors adaptable for use in embodiments
of the present invention may include: light sensors (e.g. optical
sensors or infrared sensors); sound sensors (e.g. a microphone to
pick up sounds in the ear canal); vibration sensors; heat sensors,
micro-sensors; electrochemical sensors; thin film sensors; liquid
(e.g. oil) sensors; accelerometers, microphones; gyroscopes,
including 3-axis accelerometers, 3 axis gyroscopes; MEMS sensors,
including 3 axis MEMS sensors; GPS circuitry; pedometers; reservoir
monitors; walking gait sensors; battery state monitors; energy
level monitors; and strain gauges.
[0051] In embodiments of the present invention, a suitable
microphone might be transducer 130 wired to measure back
electromagnetic fields (back EMF) which is generated when post 134
is moved independent of any drive signal provided to transducer
130, such as by vibrations in the tympanic membrane TM resulting
from, for example the user speaking or snoring. The back EMF could
then be provided to data processor 200 where it could be analyzed
and transmitted to a receiver in lateral ear canal assembly 12 or
in a remote receiver (e.g. a smart phone) by transmitter 210. In
one embodiment of the invention, data processor 200 could include
circuitry used to separate sounds coming from sources other than
the user from sounds generated by the user to provide filtered
data, which filtered feedback data may represent, for example, the
user's voice.
[0052] In embodiments of the invention, a suitable optical sensor
may comprise an infrared transmitter and infrared receiver. In
embodiments of the invention, a suitable optical sensor may include
an optical receiver tuned to the same frequency as signal source
320.
[0053] In embodiments of the invention, sensors may be 3D printed
on or as an integral part of structures in the components of
hearing system 10. In embodiments of the invention, non-skin
contacting sensors may be mounted on, for example, the back side of
photodetector 150.
[0054] In embodiments of the invention, a light may be mounted on
medial ear canal assembly 100 and positioned to shine through
tympanic membrane TM to illuminate the middle ear and the contents
thereof. In embodiments of the invention, a sensor may be further
included on medial ear canal assembly 100 to measure light
reflected from the middle ear.
[0055] In embodiments of the invention, sensors on medial ear canal
assembly 100 may be used to sense the position of transducer
assembly with respect to structural features of the ear canal EC,
such as the tympanic membrane TM. The data from such sensors may be
used to position the medial ear canal assembly 100 to ensure it is
properly placed and aligned in the user's ear.
[0056] In embodiments of the invention, sensors on medial ear canal
assembly 100 or positioned in the ear canal EC may be used to
measure environmental factors which are related to the proper
functioning of the medial ear canal assembly 100, such as,
degradation in photodetector output, earwax buildup, whether the
user is compliant with the required oiling regimine. In embodiments
of the invention, sensors may be used to ensure that the user is
properly oiling by, for example, measuring the amount and
regularity of oiling. In embodiments of the invention, sensors on
the eartip may be used to guide and/or detect proper medial ear
canal assembly insertion. In embodiments of the invention, pressure
sensors and/or fluid sensors may be positioned on a medial ear
canal assembly, including on the umbo pad 136 or sulcus platform to
assist in the preceding tasks.
[0057] In embodiments of the invention, strain gauges may be
included in the medial ear canal assembly 100 to provide feedback
on the proper placement of medial ear canal assembly 100. For
example, post 134 may include strain gauges which indicate when
displacement starts and/or the degree of displacement by
registering the lateral force on umbo pad 136. Further, the
placement of one or more strain gages on retention structure 110
may provide an indication that the medial ear canal assembly 100
has lifted off of the tympanic membrane TM. In embodiments of the
invention, medial ear canal assembly 100 may include features which
interact with physical features of the wearer to maintain medial
ear canal assembly 100 in a predetermined position in the ear canal
EC, such as, for example against the tympanic membrane TM. In
embodiments of the invention, such physical features may create
strain on the medial ear canal assembly 100, which strain may be
measured by strain gauges positioned on medial ear canal assembly
100 to ensure proper placement of medial ear canal assembly
100.
[0058] In embodiments of the invention, a feedback signal
representative of the average power received by photodetector 150
may be provided, which signal may be used to quantify the coupling
efficiency between photodetector 150 and signal source 320. In
embodiments of the invention, the power level of signal source 320
may be adjusted to reflect the degree of coupling and the coupling
efficiency indicated by the feedback signal. In embodiments of the
invention, the position of lateral ear canal assembly 12 and/or
medial ear canal assembly 100 may be modified to increase or
decrease the level of the feedback signal, thus improving the
coupling efficiency between the lateral ear canal assembly 12 and
the medial ear canal assembly 100.
[0059] In embodiments of the invention, noise cancelation may be
implemented by, for example, incorporating a microphone onto the
back of photodetector 150. Sound signals received by the microphone
could be converted into drive signals which move the tympanic
membrane in opposition to the received signals such that the
received signals are not perceived by the user. Such noise
cancelation may be implemented such that the microphone is turned
on only when the output from the photodetector exceeds a
predetermined voltage, such as, for example, approximately 300
millivolts. Alternatively, or in combination, the microphone may be
turned on when the photodetector output voltage exceeds
approximately 1 volt. In one embodiment of the invention, the sound
signals may be measured by measuring the back EMF of transducer 130
and generating a signal to the transducer which causes the
transducer to vibrate the tympanic membrane in a way which cancels
the movement which generated the measured back EMF.
[0060] In embodiments of the present invention, sensors on medial
ear canal assembly 100 or positioned in the ear canal EC may be
used to measure bodily fluids, such as sweat, interstitial fluid,
blood and/or cerumen (ear wax). Sensors suitable for making these
measurements include electrochemical sensors, micro-needles and
capacitive sensors.
[0061] In embodiments of the present invention, sensors on medial
ear canal assembly 100 or positioned in the ear canal EC may be
used to measure sweat for the purpose of, for example, measuring
hydration levels, electrolyte balance, lactate threshold, glucose
levels, calories burned, respiration rate, drug levels,
metabolites, small molecules (e.g. amino acids, DHEA, cortisol, pH
levels and various proteins. Sensors suitable for making these
measurements include electrochemical sensors, micro-needles and
capacitive sensors.
[0062] In embodiments of the present invention, sensors on medial
ear canal assembly 100 or positioned in the ear canal EC may be
used to measure the temperature, including the core body
temperature of a user. Sensors suitable for making these
measurements include thermometers, thermocouples, and optical
temperature sensors.
[0063] In embodiments of the present invention, sensors on medial
ear canal assembly 100 or positioned in the ear canal EC may be
used to measure and/or monitor blood pressure, blood flow, heart
rate, pulse, and arrhythmia. Sensors suitable for making these
measurements include electrodes, PPG (Photoplethysmography) sensors
and pulse oximetry sensors.
[0064] In embodiments of the present invention, sensors on medial
ear canal assembly 100 or positioned in the ear canal EC may be
used to measure and/or monitor the oxygen level in a user's blood.
Sensors suitable for making these measurements include optical
sensors PPG (Photoplethysmography) sensors, and/or pulse oximetry
sensors.
[0065] In embodiments of the present invention, sensors on medial
ear canal assembly 100 or positioned in the ear canal EC may be
used to measure and/or monitor drug delivery and/or medication use
by monitoring the drug content in blood or interstitial fluid of a
user. Sensors suitable for making these measurements include
micro-needles and/or iontophoresis electrodes.
[0066] In embodiments of the present invention, sensors on medial
ear canal assembly 100 or positioned in the ear canal EC may be
used to measure and/or monitor body fat. Sensors suitable for
making these measurements include electrodes.
[0067] Physical Monitoring
[0068] In embodiments of the present invention, sensors on medial
ear canal assembly 100 or positioned in the ear canal EC may be
used to monitor and/or measure sleep, including the duration and/or
quality of such sleep. Sensors suitable for making these
measurements include accelerometers, microphones and
gyroscopes.
[0069] In embodiments of the present invention, sensors on medial
ear canal assembly 100 or positioned in the ear canal EC may be
used to measure and/or monitor snoring and/or sleep apnea. Sensors
suitable for making these measurements include accelerometers,
microphones; gyroscopes; head position monitors (3 axis gyroscope);
vibration sensor (microphone, TMT microactuator); oxygen sensors;
and trigeminal nerve monitors.
[0070] In embodiments of the present invention, sensors on medial
ear canal assembly 100 or positioned in the ear canal EC and/or on
the tympanic membrane may be used to measure and/or monitor the
location of a user. Sensors suitable for making these measurements
include GPS circuitry.
[0071] In embodiments of the present invention, sensors on medial
ear canal assembly 100 or positioned in the ear canal EC may be
used to measure and/or monitor the movement of a user. Sensors
suitable for making these measurements include an accelerometer
and/or a pedometer.
[0072] In embodiments of the present invention, sensors on medial
ear canal assembly 100 or positioned in the ear canal EC may be
used to measure and/or monitor calorie intake. Sensors suitable for
making these measurements include microphones and piezoelectric
sensors.
[0073] In embodiments of the present invention, sensors on medial
ear canal assembly 100 or positioned in the ear canal EC may be
used to measure and/or monitor posture, head position and/or body
position. Sensors suitable for making these measurements include
gyroscopes, accelerometers (including 3-axis accelerometers) and
MEMS sensors (including 3 axis MEMS sensors).
[0074] In embodiments of the present invention, sensors on medial
ear canal assembly 100 or positioned in the ear canal EC may be
used to measure and/or monitor seizure disorders, including
epilepsy, by making electroencephalogram (EEG) measurements.
Sensors suitable for making these measurements include electrodes
and/or electroencephalograph.
[0075] In embodiments of the present invention, sensors on medial
ear canal assembly 100 or positioned in the ear canal EC may be
used to measure and/or monitor electrical activities of the heart
by making an electrocardiogram (ECG/EKG). Sensors suitable for
making these measurements may include electrodes and/or
electrocardiographs.
[0076] In embodiments of the present invention, sensors on medial
ear canal assembly 100 or positioned in the ear canal EC may be
used to measure and/or monitor the electrical activity produced by
skeletal muscles by making an electromyogram using Electromyography
(EMG). Sensors suitable for making these measurements may include
electrodes and/or electromyographs.
[0077] In embodiments of the present invention, sensors on medial
ear canal assembly 100 or positioned in the ear canal EC may be
used to measure and/or monitor the glucose in a user's blood and/or
interstitial fluid. Sensors suitable for making these measurements
include glucose meters, electrochemical sensors, microneedles,
and/or iontophoresis electrodes.
[0078] In embodiments of the present invention, sensors on medial
ear canal assembly 100 or positioned in the ear canal EC may be
used to measure and/or monitor neurological function. Sensors
suitable for making these measurements may include sensors for
measuring the walking gait of a user.
[0079] In embodiments of the present invention, sensors on medial
ear canal assembly 100 or positioned in the ear canal EC may be
used to measure and/or monitor the position and/or orientation of a
user's eye.
[0080] Many other physical characteristics may be measured by
sensors on medial ear canal assembly 100 or positioned in the ear
canal EC, including: multi-axis acceleration; multi-axis angle;
skin capacitance; infrared absorption, (e.g. pulse ox), chemical
reactions; and strains.
[0081] In embodiments of the present invention, devices on medial
ear canal assembly 100 or positioned in the ear canal EC may be
used to deliver medication to a user. Devices suitable for making
these delivers may include drug reservoirs, patches, microneedles,
polymers designed to elute over time and/or drug eluting
materials.
[0082] In embodiments of the invention, drugs may be delivered
through, for example, iontophoresis, direct skin contact, needles,
drugs in the platform, drug infused silicon or other structural
materials or holes or pores in the tympanic membrane structure to
hold drugs prior to dispensing or weep over time.
[0083] In embodiments of the present invention, devices on medial
ear canal assembly 100 or positioned in the ear canal EC may be
used to stimulate serotonin production in a user by, for example,
shining light in the ear canal EC for predetermined periods of
time. Alternatively, such devices may be adapted to increase the
production of vitamin D.
[0084] In embodiments of the present invention, devices, including
sensors on medial ear canal assembly 100 or positioned in the ear
canal EC may be used to recognize the speech of a user. Devices
suitable for making these delivers may include microphones and
speech recognition/signal processing chips and software.
[0085] In embodiments of the present invention, sensors on medial
ear canal assembly 100 or positioned in the ear canal EC may be
used to control the function of hearing system 10. The function of
hearing system 10 may be controlled by, for example, sensing
control instructions from the user, including, verbal instructions
and/or instructions conveyed by finger snapping, bone conduction
and/or bringing a hand or finger into proximity with the sensors on
medial ear canal assembly 100. Sensors suitable for such control
functions may include touch sensors, bone conduction sensors and
proximity sensors.
[0086] In embodiments of the present invention, the power required
to operate sensors, drug delivery, and/or other devices located on
medial ear canal assembly 100 may be supplied by one or more of the
following: AC or DC current from photodetector 150; AC or DC
current from an RF antenna located on or connected to medial ear
canal assembly 100; Energy from a battery, micro-battery and/or
super capacitor on or connected to medial ear canal assembly 100.
In further embodiments of the present invention, circuitry on
medial canal assembly 100 may be obtained by, for example:
harvesting power from the motion of the user, including the dynamic
motion of the wall of an outer ear, using, for example, a spring
located on or connected to medial ear canal assembly 100;
harvesting power from the motion of the tympanic membrane,
including harvesting sound energy which vibrates the tympanic
membrane; harvesting power from the motion of the tympanic
membrane, including harvesting sound energy below approximately 100
Hz; harvesting power from the action of muscles in or near the ear
canal, such as, for example muscles used in chewing food;
harvesting power from the temporomandibular joint; using the
movement of the eardrum (such as, for example, driven by music) to
act as a pump. In embodiments of the invention circuitry on medial
ear canal assembly 100 may be powered by, for example, the use of
light based earplugs which transmits energy to medial ear canal
assembly 100 to power the assembly when lateral ear canal assembly
12 is not being used. In embodiments of the invention, such light
based earplugs may be used to recharge batteries or super
capacitors located on or connected to medial ear canal assembly
100. In embodiments of the invention circuitry on medial ear canal
assembly 100 may be powered by, for example, a wand which radiates,
for example, RF energy to an antenna located on or connected to
medial ear canal assembly 100 to power sensors on medial ear canal
assembly 100 and/or in the ear canal EC for the purpose of making
measurements.
[0087] In embodiments of the present invention, sensors located on
medial ear canal assembly 100 may communicate data to any one of a
number of devices, including lateral ear canal assembly 12, a
smartphone, a smart watch, a cellular network, a ZigBee network, a
Wi-Fi network, a WiGi-G network, and/or a Bluetooth enabled device.
In embodiments of the present invention, such information may be
transmitted from medial ear canal assembly 100 to lateral ear canal
assembly 12 and from lateral ear canal assembly 12 to a smartphone,
a smart watch, a cellular network, a ZigBee network, and/or a
Bluetooth enabled device. In embodiments of the invention, such
sensors a part of a closed loop communication network. In
embodiments of the invention, communication to medial ear canal
assembly 100 may be facilitated by the positioning of an antenna on
or connected to medial ear canal assembly 100. In embodiments of
the invention, such antennas may be printed on or formed as part of
a chassis of medial ear canal assembly 100. In embodiments of the
present invention, communication of data may be facilitated by the
inclusion of transmitter 210 on medial ear canal assembly 100.
[0088] In embodiments of the invention, removable portions of
hearing system 10 may sense emergency situations, such as fire
alarms, and communicate with the user wearing medial ear canal
assembly 100 using an antenna located on or connected to medial ear
canal assembly 100 to warn the user of danger.
[0089] In embodiments of the invention, data collected from sensors
located on medial ear canal assembly 100 or in the ear canal EC of
a user may be communicated to the user's physician and/or family.
In embodiments of the invention, data collected from sensors
located on medial ear canal assembly 100 or in the ear canal EC of
a user may be used to generate data or reports which may be
communicated to the user's physician and/or family. In embodiments
of the present invention, information, data or reports which may be
communicated to the user, the user's physician and/or family may
include information on the user's environment, including time of
day, activity, surrounding sounds. In embodiments of the present
invention, information, data or reports which may be communicated
to the user, the user's family physician, and/or family may include
information on biometric date related to the user, including blood
pressure, heart rate, glucose levels, and other biometric data. In
embodiments of the present invention, information, data or reports
which may be communicated to the user, the user's family physician
and/or family may include information on specific events related to
the user or the user's physical condition, including, falls, blood
pressure spikes, heart attacks, temperature spikes, impending or
actual seizures, changes in specific biomarkers, or other metrics.
In embodiments of the present invention, information, data or
reports which may be communicated to the user, the user's family
physician and/or family may include algorithm results transmitted
when trends or parameters in the user's biometric data become
concerning. In embodiments of the present invention, information,
including warnings may be communicated to the user may include,
sleep apnea warnings, drowsiness warnings (e.g. when driving),
warnings of impending seizures, migraine headaches warnings, and/or
cluster headache warnings.
[0090] In embodiments of the invention, medial ear canal assembly
100 may be used to communicate with the user to, for example,
remind the user when to drink or when the user's sugar levels are
spiking or dropping.
[0091] In embodiments of the present invention, data or other
information may be transmitted by a user to the hearing system 10
of a second user. In embodiments of the invention, a user may
transmit data or other information to a network of hearing systems
10.
[0092] In embodiments of the present invention, data collected by
sensors positioned on medial ear canal assembly 100 or in the ear
canal of a user may be collected and analyzed, by, for example, an
Application on the user's smart phone. Such data may be used for
many purposes, including predicating changes in the user's health
and generating event alarms.
[0093] Event alarms generated from the collected data might include
alarms related to epilepsy seizures, migraines, cluster headaches,
or predetermined changes in key biometric data or trends. Such data
may be further processed to allow the user to, for example, view
the data which is most important to the user, perform trend
analysis on the data, correlate specific data with activities or
environment, provide a dashboard of data or chart specific data.
Data may also be stored for review at future doctor's appointments.
Data trends may also be stored and analyzed over time.
[0094] Embodiments of the present invention are directed to a
hearing system comprising a medial ear canal assembly including a
transducer configured to be positioned on the tympanic membrane of
a user; a lateral ear canal assembly including a signal source
configured to be positioned in the ear canal of a user; and sensors
connected to the medial ear canal assembly, the sensors being
connected to a transmitter. In embodiments of the invention, the
sensors may include sensors adapted to detect biometric data. In
embodiments of the invention, the sensors may include sensors
adapted to detect one or more physical characteristics of the user.
In embodiments of the invention, at least one of the sensors may
comprise a microphone. In embodiments of the invention, the
microphone may comprise a micro-actuator. In embodiments of the
invention, sound received by the micro-actuator is configured to be
converted to a back EMF signal. In embodiments of the invention,
the hearing system may include a data processor which is configured
to convert the back EMF to a signal representative of the sound
received by the micro-actuator. In embodiments of the invention the
hearing system may be configured to transmit the signal
representative of the sound received by the microactuator to a
receiver external to the hearing system. In embodiments of the
invention, the receiver comprises a smart phone, a wireless
network, or a peripheral device. In embodiments of the invention,
at least one of the sensors comprises a skin contacting sensor or a
non-skin contacting sensor. In embodiments of the invention, at
least one of the sensors comprises an umbo sensor, an eartip
sensor, or a tethered sensor.
[0095] Embodiments of the present invention are directed to a
method of sensing physical characteristics of a hearing system
user, the hearing system comprising a medial ear canal assembly
positioned on or near the tympanic membrane, the medial ear canal
assembly comprising transducer sensors and a transmitter, the
method comprising the steps of: using the sensors to measure
biometric data of the user; and transmitting the measured biometric
data using the transmitter. In embodiments of the invention the
method further comprising using the sensors to measure one or more
physical characteristics of the user. In embodiments of the
invention at least one of the sensors comprises a microphone the
method further comprising the steps of measuring sound in the
user's ear canal. In embodiments of the invention the microphone
comprises a micro-actuator, the method further comprising measuring
the back EMF signal. In embodiments of the invention the hearing
system includes a data processor, the method further including the
step of converting the back EMF signal to an electrical signal and
transmitting the electrical signal to the data signal processor. In
embodiments of the invention the back EMF signal includes a first
signal portion representative of the signal received from the
hearing system and a second signal representative of at least one
physical characteristic of the user, the method further including
the step of separating the first signal from the second signal. In
embodiments of the invention the method further includes the step
of transmitting the signal to a receiver external to the hearing
system. In embodiments of the invention the receiver comprises a
smart phone. In embodiments of the invention at least one of the
sensors comprises a skin contacting sensor or a non-skin contacting
sensor. In embodiments of the invention at least one of the sensors
comprises an umbo sensor, an eartip sensor, or a tethered sensor.
In embodiments of the invention the output transducer is used as a
sensor. In embodiments of the invention the sensor is used as a
microphone to measure received sound at the tympanic membrane. In
embodiments of the invention the signal from the microphone is
coupled to the transmitter.
[0096] Embodiments of the present invention are directed to an ear
canal platform comprising: a medial ear canal assembly positioned
on or over the tympanic membrane of a user; and sensors connected
to the signal output transducer, the sensors being connected to a
transmitter. In embodiments of the invention the sensors include
sensors adapted to detect biometric data. In embodiments of the
invention the sensors include sensors adapted to detect one or more
physical characteristics of the user. In embodiments of the
invention at least one of the sensors comprises a microphone. In
embodiments of the invention the microphone comprises a
micro-actuator. In embodiments of the invention sound received by
the micro-actuator is configured to be converted to a voltage
representative of the back EMF generated in the microactuator by
the sound received by the microactuator. In embodiments of the
invention the hearing system includes a data processor which is
configured to convert the voltage to a signal representative of the
sound received by the micro-actuator. In embodiments of the
invention the signal is configured to be transmitted by the hearing
system to a receiver external to the hearing system. In embodiments
of the invention the receiver comprises a smart phone, a wireless
network, or a peripheral device. In embodiments of the invention at
least one of the sensors comprises a skin contacting sensor or a
non-skin contacting sensor. In embodiments of the invention at
least one of the sensors comprises an umbo sensor, an eartip
sensor, or a tethered sensor.
[0097] Embodiments of the present invention are directed to a
method of sensing physical characteristics of a user having a
medial ear canal assembly positioned on or near the tympanic
membrane, the medial ear canal assembly comprising sensors and a
transmitter, the method comprising the steps of: using the sensors
to measure biometric data of the user; and transmitting the
measured biometric data using the transmitter. In embodiments of
the invention the method further comprising using the sensors to
measure one or more physical characteristics of the user. In
embodiments of the invention at least one of the sensors comprises
a microphone the method further comprising the steps of measuring
sound in the user's ear canal. In embodiments of the invention the
microphone comprises a micro-actuator, the method further
comprising measuring and transmitting the output of the microphone.
In embodiments of the invention the hearing system includes a data
processor, the method further including the step of sending the
transmitted signal to the data processor. the transmitted signal
includes a first signal portion representative of the signal
received from the hearing system and a second signal representative
of a physical characteristic of the user, the method further
including the step of separating the first signal from the second
signal. In embodiments of the invention the method further includes
the step of transmitting the signal to a receiver external to the
hearing system. In embodiments of the invention the receiver
comprises a smart phone. In embodiments of the invention at least
one of the sensors comprises a skin contacting sensor or a non-skin
contacting sensor. In embodiments of the invention at least one of
the sensors comprises an umbo sensor, an eartip sensor, or a
tethered sensor. In embodiments of the invention the output
transducer is used as a sensor. In embodiments of the invention the
sensor is used as a microphone to measure received sound at the
tympanic membrane. In embodiments of the invention the signal from
the microphone is coupled to the transmitter.
[0098] Embodiments of the present invention are directed to an ear
canal platform comprising: a medial ear canal assembly positioned
on the tympanic membrane of a user; a drug delivery device mounted
on the ear canal assembly. In embodiments of the invention an ear
canal assembly further includes sensors connected to the ear canal
assembly, the sensors being connected to a transmitter. In
embodiments of the invention the sensors include sensors adapted to
detect biometric data. In embodiments of the invention the sensors
include sensors adapted to detect one or more physical
characteristics of the user. In embodiments of the invention at
least one of the sensors is a microphone. In embodiments of the
invention the microphone is a micro-actuator. In embodiments of the
invention sound received by the micro-actuator is converted to a
transmitted signal. In embodiments of the invention the hearing
system includes a data processor which converts the transmitted
signal to a signal representative of the sound received by the
micro-actuator. In embodiments of the invention the signal is
transmitted by the hearing system to a receiver external to the
hearing system. In embodiments of the invention the receiver is a
smart phone, a wireless network, or a peripheral device. In
embodiments of the invention at least one of the sensors comprises
a skin contacting sensor, or a non-skin contacting sensor. In
embodiments of the invention at least one of the sensors comprises
an umbo sensor, an eartip sensor, or a tethered sensor.
[0099] Embodiments of the present invention are directed to a
method of delivering drugs to a user having a medial ear canal
assembly positioned on or near the user's tympanic membrane, the
medial ear canal assembly comprising a drug delivery device, the
method comprising the steps of: delivering drugs to the user
through the drug delivery device. In embodiments of the invention
the medial ear canal assembly further includes sensors and a
transmitter, the method comprising the steps of: using the sensors
to measure biometric data of the user; and transmitting the
measured biometric data using the transmitter. In embodiments of
the invention the method further includes the step of activating
the drug delivery device using the biometric data measured by the
sensors. In embodiments of the invention the method further
comprises using the sensors to measure one or more physical
characteristics of the user. In embodiments of the invention the
method further comprises the step of activating the drug delivery
device using the measured physical characteristics of the user. In
embodiments of the invention, the step of activating drug delivery
includes activating drug delivery when needed and/or at
predetermined times or over predetermined time periods. In
embodiments of the invention at least one of the sensors comprises
a skin contacting sensor or a non-skin contacting sensor. In
embodiments of the invention at least one of the sensors comprises
an umbo sensor, an eartip sensor, or a tethered sensor. In
embodiments of the invention, the system may comprise a reservoir
and mechanisms for drug delivery.
[0100] While the preferred embodiments of the devices and methods
have been described in reference to the environment in which they
were developed, they are merely illustrative of the principles of
the present inventive concepts. Modification or combinations of the
above-described assemblies, other embodiments, configurations, and
methods for carrying out the invention, 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. In addition, where
this application has listed the steps of a method or procedure in a
specific order, it may be possible, or even expedient in certain
circumstances, to change the order in which some steps are
performed, and it is intended that the particular steps of the
method or procedure claim set forth hereinbelow not be construed as
being order-specific unless such order specificity is expressly
stated in the claim.
* * * * *