U.S. patent application number 13/656344 was filed with the patent office on 2013-04-25 for methods and devices for treating hypertension.
The applicant listed for this patent is Kevin Joe Ehrenreich, Kelly Justin McCrystle, Randolf von Oepen. Invention is credited to Kevin Joe Ehrenreich, Kelly Justin McCrystle, Randolf von Oepen.
Application Number | 20130102937 13/656344 |
Document ID | / |
Family ID | 48136539 |
Filed Date | 2013-04-25 |
United States Patent
Application |
20130102937 |
Kind Code |
A1 |
Ehrenreich; Kevin Joe ; et
al. |
April 25, 2013 |
Methods and Devices for Treating Hypertension
Abstract
Devices, systems and methods are described which control blood
pressure and nervous system activity by stimulating baroreceptors.
By selectively and controllably activating baroreceptors and/or
nerves, the present invention reduces blood pressure and alters the
sympathetic nervous system; thereby minimizing deleterious effects
on the heart, vasculature and other organs and tissues. A
baroreceptor activation device or other sensory activation device
is positioned near a dermal bone to provide the treatment.
Inventors: |
Ehrenreich; Kevin Joe; (San
Francisco, CA) ; Oepen; Randolf von; (Aptos, CA)
; McCrystle; Kelly Justin; (Menlo Park, CA) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Ehrenreich; Kevin Joe
Oepen; Randolf von
McCrystle; Kelly Justin |
San Francisco
Aptos
Menlo Park |
CA
CA
CA |
US
US
US |
|
|
Family ID: |
48136539 |
Appl. No.: |
13/656344 |
Filed: |
October 19, 2012 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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61681513 |
Aug 9, 2012 |
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|
61681469 |
Aug 9, 2012 |
|
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61648060 |
May 16, 2012 |
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61549007 |
Oct 19, 2011 |
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Current U.S.
Class: |
601/47 |
Current CPC
Class: |
A61H 23/0236 20130101;
A61H 2023/002 20130101; A61H 2201/5002 20130101; A61H 2201/5028
20130101; A61H 2201/1207 20130101; A61H 2201/5007 20130101; A61H
2230/065 20130101; A61B 5/6833 20130101; A61H 23/00 20130101; A61H
2201/0207 20130101; A61H 2201/0196 20130101; A61H 2201/5092
20130101; A61H 23/02 20130101; A61H 2201/5043 20130101; A61B 5/4818
20130101; A61H 2201/5015 20130101; A61B 2562/0219 20130101; A61B
5/0205 20130101; A61H 2230/305 20130101; B33Y 80/00 20141201; A61H
23/0245 20130101; A61H 2201/5038 20130101; A61H 2230/705 20130101;
A61B 5/02208 20130101; A61H 2201/1614 20130101; A61H 2230/045
20130101; A61H 2230/505 20130101; A61H 2201/165 20130101; A61H
2201/5035 20130101; A61B 5/6803 20130101; A61B 5/6843 20130101;
A61H 2201/5097 20130101; A61B 5/053 20130101; A61H 1/00 20130101;
A61B 5/1112 20130101; A61H 2201/1609 20130101; A61H 2201/5041
20130101; A61H 2201/5084 20130101; A61H 23/04 20130101; A61H
2230/208 20130101; A61H 2201/5058 20130101 |
Class at
Publication: |
601/47 |
International
Class: |
A61H 1/00 20060101
A61H001/00 |
Claims
1. A device for treating hypertension, comprising: a housing, the
housing having a proximal surface and a distal surface, wherein the
housing further includes a mounting system, the mounting system
including a first member and a second member, the first member
associated with the housing and the second member configured to be
received by tissue; and a driver assembly coupled to the
housing.
2. The device according to claim 1, wherein the second member
includes a first surface and a second surface and one of the
surfaces includes an adhesive.
3. The device according to claim 2, wherein the second member is
configured to be placed over the clavicle of a user.
4. The device according to claim 1, further comprising an
electronics module.
5. The device according to claim 4, wherein the electronics module
further includes a wireless communication chip.
6. The device according to claim 4, further including a memory
chip.
7. The device according to claim 1, wherein the driver assembly is
a haptic transducer.
8. The device according to claim 1, wherein the driver assembly is
a magnetic speaker.
9. The device according to claim 1, further including an energy
source disposed within the housing.
10. The device according to claim 9, wherein the energy source is
removable.
11. The device according to claim 9, wherein the energy source is
rechargeable.
12. The device according to claim 11, wherein the energy source is
rechargeable through a non-contact charger.
13. A device for imparting energy to a patient, comprising: a
housing, the housing having a first surface and a second surface,
the surfaces defining a volume therebetween, wherein the housing
further includes a mounting system, the mounting system including a
first member and a second member, the first member associated with
the housing and the second member configured to be received by
tissue; a driver assembly disposed within the volume of the
housing; an energy source coupled to the driver assembly; and an
electronics module coupled to the driver assembly and the energy
source.
14. The device according to claim 13, wherein the electronics
module further includes a wireless communication module.
15. The device according to claim 14, further including a computing
device, the computing device configured to run a program.
16. The device according to claim 15, wherein the computing device
is in wireless communication with the electronics module and the
program running on the computing device controls the electronics
module to activate or deactivate the driver assembly.
17. A method of providing therapy, the method comprising: applying
a therapy applying device to a collar bone of a patient; and
activating a driver assembly within the therapy applying
device.
18. The method according to claim 17, wherein the driver assembly
is a speaker.
19. The method according to claim 17, wherein the driver assembly
is a haptic transducer.
20. The method according to claim 17, wherein the driver assembly
produces a signal within the range of 0.1 Hz and 20,000 Hz.
21. The method according to claim 19, wherein the driver assembly
is activated by said program at pre-programmed times.
Description
CROSS REFERENCE TO RELATED APPLICATIONS
[0001] This application claims priority to U.S. Provisional Patent
Application No. 61/549,007 filed Oct. 19, 2011 titled "Hypertension
and Heart Rate Reduction," and U.S. Provisional Patent Application
No. 61/648,060 filed May 16, 2012 titled "Methods and Devices for
Treating Hypertension," and U.S. Provisional Patent Application No.
61/681,469 filed Aug. 9, 2012 titled "Methods and Devices for
Treating Hypertension Using and Electroactive Transducer," and U.S.
Provisional Patent Application No. 61/681,513 filed on Aug. 9, 2012
titled "Support Assemblies For The Treatment of Hypertension," the
entireties of which are hereby incorporated by reference.
BACKGROUND OF THE INVENTION
[0002] This invention relates generally to methods and devices for
the treatment of hypertension. More specifically, methods and
devices which treat hypertension using devices disposed extra
corporally.
[0003] Hypertension, or high blood pressure, affects millions of
people every day and is a serious health hazard. Hypertension is
associated with an elevated risk for heart attack, heart failure,
arterial aneurysms, kidney failure and stroke. There are many
factors that may affect blood pressure, such as: salt intake,
obesity, occupation, alcohol intake, smoking, pregnancy, stimulant
intake, sleep apnea, genetic susceptibility, decreased kidney
perfusion, arterial hardening and medication(s). Many times people
are unaware that they suffer from hypertension until it is
discovered during a medical check-up with their health care
practitioner (HCP), or worse, it is discovered when they are
hospitalized for a hypertension related condition such as a heart
attack or stroke.
[0004] Blood pressure is controlled by a complex system within the
body, one component of this system is known as the arterial
baroreflex (ABR). The baroreflex is the fastest autonomic reflex
responding to changes in blood pressure. The baroreceptor nerve
endings are embedded in vessels throughout the circulatory system
and encode both mean pressure and rate of change of pressure as a
frequency. Centers in the brainstem process spikes in the frequency
information, integrating it with other information and providing a
signal to the sinoatrial (SA) pacemaking node of the heart via
efferent fibers in the vagus nerve. When blood pressure becomes too
high, the resulting vagal nerve signal triggers the release of
acetylecholine at the SA node of the heart, slowing the heart rate
and thus lowering the blood pressure.
[0005] Baroreceptors are located in the transverse aortic arch and
the carotid sinuses of the left and right internal carotid
arteries. The baroreceptors found within the aortic arch monitor
the pressure of blood delivered to the systemic circuit, and the
baroreceptors within the carotid arteries monitor the pressure of
the blood being delivered to the brain.
[0006] As described above, the arterial baroreceptors are stretch
receptors that are stimulated by distortion of the arterial wall
when pressure changes. The baroreceptors can identify the changes
in the average blood pressure or the rate of change in pressure
with each arterial pulse. Action potentials triggered in the
baroreceptor endings are then conducted to the brainstem where
central terminations (synapses) transmit this information to
neurons within the solitary nucleus. Reflex responses from such
baroreceptor activity can trigger increases or decreases in the
heart rate. Arterial baroreceptor (ABR) sensory endings are simple,
sprayed nerve endings that lie in the tunica adventitia of the
artery. An increase in the mean arterial pressure increases
depolarization of these sensory endings, which results in action
potentials. These action potentials are conducted to the solitary
nucleus in the central nervous system by axons and have a reflex
effect on the cardiovascular system through autonomic neurons.
[0007] At normal resting blood pressures, baroreceptors discharge
at approximately 1 out of every 3 heart beats. If blood pressure
falls, the arteries retract in diameter and the baroreceptor firing
rate decreases with the drop in blood pressure the brain send a
signal to the heart to increase blood pressure by increasing heart
rate. Signals from the carotid baroreceptors are sent via the
glossopharyngeal nerve (cranial nerve IX). Signals from the aortic
baroreceptors travel through the vagus nerve (cranial nerve X).
Arterial baroreceptors inform reflexes about arterial blood
pressure.
[0008] The arterial baroreflex system is a dynamic system that is
capable of adapting to ever changing situations. The ABR is the
reason why we do not pass out when moving from a seated to standing
position. In this instance the ABR senses a change in blood
pressure and accommodates the change by sending the appropriate
signal to regulate blood pressure. The ABR system also performs an
essential function to regulate blood pressure during exercise,
wherein during exercise your heart rate increases as well as your
blood pressure, however, at a certain point during exercise the ABR
will intervene, allowing the heart rate to further increase but not
allowing the blood pressure to further increase.
[0009] As stated above, hypertension currently affects a large and
growing population. Currently treatments for hypertension range
from prescribed lifestyle changes and the use of pharmaceutical
products. Within the past couple of years, new surgical therapies
are emerging. These surgical therapies either lead to the
implantation of a device for stimulating a patient's carotid
baroreceptor or to the disconnection of the nerves of the renal
arteries.
[0010] If prescribed lifestyle changes do not address a patient's
hypertension, their HCP will typically prescribe drug therapy to
treat their hypertension. There are multiple classes of
pharmaceutical products that can be utilized to treat hypertension.
These include vasodilators to reduce the blood pressure and ease
the workload of the heart, diuretics to reduce fluid overload,
inhibitors and blocking agents of the body's neurohormonal
responses, and other medicaments. Many times, a HCP will prescribe
one or more of these products to a patient to be taken in
combination in order to lower their blood pressure. However, the
use of pharmaceutical products is not without their risks. Many of
these products carry severe warnings of potential side effects.
Additionally, each patient may respond differently to the products,
therefore multiple office visits may be required before the right
dosage and type of pharmaceutical products are selected, which
leads to greater health care costs. Further still there are a
number of patients who either do not respond to medication, refuse
to take medication, or over time the medication no longer provides
a therapeutic effect. Recently, new clinical trial data has drawn
correlations between the use of diuretic pharmaceutical products to
treat high blood pressure and the formation of diabetes within the
patient.
[0011] For patients who do not respond to drug therapy, there are
medical devices and treatments that can be utilized to treat high
blood pressure. Some of these devices involve invasive surgical
procedures including the implantation of a permanent medical device
within a patient's artery to impart a force at a specific location
within the artery which then may cause a lowering of blood
pressure. However, these devices are relatively new or are still
under development and have not been proven over a long period of
time. Also, since the device is a permanent implant, there is
always the possibility of complications during the implantation
process or infections related to the implantation.
[0012] As described above, another type of invasive medical device
is an electrical signal generating implant, where electrodes are
placed adjacent to the carotid artery. With this process, the
surgeon must be careful not to sever any of the nerves while
implanting the device. If the nerves are severed, then the device
will not function properly and may lead to long term health
complications for the patient. However, even more troubling is that
the patient has now permanently lost a baroreceptor for controlling
blood pressure naturally, which may lead to complications later,
which are currently unknown. Additionally, the implant device
requires regular battery replacement, which to do so requires
another invasive surgical procedure.
[0013] Another type of invasive medical device and procedure being
developed is the use of ablation catheter to denervate the carotid
body, specifically the chemoreceptors of the carotid body. Similar
to the device and procedure described above, this device
permanently causes a disconnection between the chemoreceptors and
the nervous system/brain. The long term effects are unknown,
additionally, other nerves maybe destroyed or disconnected during
the procedure which may lead to other side effects.
[0014] Another type of invasive medical procedure to treat
hypertension being developed is to use an ablation catheter placed
within the renal artery, where a series of energy pulses are
performed to ablate (sever) the nerves surrounding the artery,
thereby effectively disconnecting the nerves of the kidney from the
body. This procedure results in a permanent and non-reversible
change to the patient's nervous system, this procedure is being
referred to as renal nerve ablation or renal denervation. The long
term effects of such a permanent treatment are unknown at this time
as this approach is relatively new on the market. Recently
published data has shown that not all patients respond to this
surgical procedure, that is after the procedure, some of the
patients show little to no changes in their blood pressure. This
may be concerning as now these patients have had their renal
arteries permanently disconnected from their kidneys, which may
lead to long term effects which are unknown at this time.
Additionally, the costs associated with an invasive medical
procedure are not insignificant, only to prove that the procedure
had no effect, thus, instead of potentially lowering the cost of
treatment for these patients, the cost of treating their
hypertension was significantly added to.
[0015] Additionally, the recently published data also shows that
patients who respond to renal denervation may still remain
hypertensive. Thus, the renal denervation procedure may not be a
"cure," instead it may be seen as an adjunctive therapy, as such
these patients may remain on drug therapies or are recommended to
remain on drug therapy after having undergone renal
denervation.
[0016] Yet another invasive surgical approach to address
hypertension is a combination of a device and a pharmaceutical
product, wherein a catheter with a needle disposed near its distal
end are placed within the renal artery. Once in position, a liquid
pharmaceutical product is injected into the wall of the artery,
whereby the pharmaceutical product is designed to chemically ablate
the renal nerves. Here again, this treatment procedure is
considered to be a permanent solution, whereby the nerves are
permanently severed. Long term efficacy of the severing of the
renal nerves is unknown. Additionally, long term effects of the
procedure are also unknown.
[0017] Human skin acts as the protective barrier between our
internal body systems and the outside world. Our skin in
combination with our bodies nerves provides for the ability to
perceive touch sensations and gives our brains a wealth of
information about the environment around us, such as temperature,
pain, and pressure. Without such a nervous system, we wouldn't be
able to feel our feet hitting the floor when we walked, we wouldn't
sense when something sharp cut us, and we wouldn't feel the warmth
of the sun on our skin.
[0018] Human skin is composed of several layers. The very top layer
is the epidermis and is the layer of skin you can see. In Latin,
the prefix "epi-" means "upon" or "over," thus the epidermis is the
layer upon which the dermis is disposed (the dermis is the second
layer of skin). The epidermis, made of dead skin cells, is
waterproof and serves as a protective wrap for the underlying skin
layers and the rest of the body. It contains melanin, which
protects against the sun's harmful rays and also gives skin its
color. When you are in the sun, the melanin builds up to increase
its protective properties, which also causes the skin to darken.
The epidermis also contains very sensitive cells called touch
receptors that give the brain a variety of information about the
environment the body is in.
[0019] The second layer of skin is the dermis. The dermis contains
hair follicles, sweat glands, sebaceous (oil) glands, blood
vessels, nerve endings, and a variety of touch receptors. The
dermis' primary function is to sustain and support the epidermis by
diffusing nutrients to it and replacing the skin cells that are
shed off the upper layer of the epidermis. New cells are formed at
the junction between the dermis and epidermis, and they slowly push
their way towards the surface of the skin so that they can replace
the dead skin cells that are shed. Oil and sweat glands eliminate
waste produced at the dermis level of the skin by opening their
pores at the surface of the epidermis and releasing the waste.
[0020] The bottom skin layer is the subcutaneous tissue which is
composed of fat and connective tissue. The layer of fat acts as an
insulator and helps regulate body temperature. It also acts as a
cushion to protect underlying tissue from damage when you bump into
things. The connective tissue keeps the skin attached to the
muscles and tendons underneath.
[0021] Our sense of touch is controlled by a huge network of nerve
endings and touch receptors disposed within the skin which is known
as the somatosensory system. This system is responsible for all the
sensations we feel; cold, hot, smooth, rough, pressure, tickle,
itch, pain, vibrations, and more. Within the somatosensory system,
there are four main types of receptors; mechanoreceptors,
thermoreceptors, nociceptors, and proprioceptors.
[0022] It is important to understand how specialized receptors
adapt to a change in stimulus (anything that touches the skin and
causes sensations such as hot, cold, pressure, tickle, etc.). A
touch receptor is considered rapidly adapting if it responds to a
change in stimulus very quickly. This means that it can sense right
away when the skin is touching an object and when it stops touching
that object. However, rapidly adapting receptors can't sense the
continuation and duration of a stimulus touching the skin (how long
the skin is touching an object). These receptors best sense
vibrations occurring on or within the skin. A touch receptor is
considered slowly adapting if it does not respond to a change in
stimulus very quickly. These receptors are very good at sensing the
continuous pressure of an object touching or indenting the skin but
are not very good at sensing when the stimulus started or
ended.
[0023] Mechanoreceptors are receptors which perceive sensations
such as pressure, vibrations, and texture. There are four known
types of mechanoreceptors whose only function is to perceive
indentions and vibrations of the skin: Merkel's disks, Meissner's
corpuscles, Ruffini's corpuscles, and Pacinian corpuscles.
[0024] The most sensitive mechanoreceptors, Merkel's disks and
Meissner's corpuscles, are found in the very top layers of the
dermis and epidermis and are generally found in non-hairy skin such
as the palms, lips, tongue, soles of feet, fingertips, eyelids, and
the face. Merkel's disks are slowly adapting receptors and
Meissner's corpuscles are rapidly adapting receptors so your skin
can perceive both when you are touching something and how long the
object is touching the skin.
[0025] Located deeper in the dermis and along joints, tendons, and
muscles are Ruffini's corpuscles and Pacinian corpuscles. These
mechanoreceptors can feel sensations such as vibrations traveling
down bones and tendons, rotational movement of limbs, and the
stretching of skin.
[0026] Another type of receptors are thermoreceptors, as their name
suggests, these receptors perceive sensations related to the
temperature of objects the skin feels. They are found in the dermis
layer of the skin. There are two basic categories of
thermoreceptors: hot and cold receptors.
[0027] Cold receptors start to perceive cold sensations when the
surface of the skin drops below 95.degree. F. They are most
stimulated when the surface of the skin is at 77.degree. F. and are
no longer stimulated when the surface of the skin drops below
41.degree. F. This is why your feet or hands start to go numb when
they are submerged in icy water for a long period of time.
[0028] Hot receptors start to perceive hot sensations when the
surface of the skin rises above 86.degree. F. and are most
stimulated at 113.degree. F. But beyond 113.degree. F., pain
receptors take over to avoid damage being done to the skin and
underlying tissues.
[0029] Thermoreceptors are found all over the body, but cold
receptors are found in greater density than heat receptors. The
highest concentration of thermoreceptors can be found in the face
and ears.
[0030] Another type of receptor are pain receptors, commonly known
as nociceptors, "Noci-" in Latin means "injurious" or "hurt." These
receptors detect pain or stimuli that can or does cause damage to
the skin and other tissues of the body. There are over three
million pain receptors throughout the body, found in skin, muscles,
bones, blood vessels, and some organs. They can detect pain that is
caused by mechanical stimuli (cut or scrape), thermal stimuli
(burn), or chemical stimuli (poison from an insect sting).
[0031] These receptors cause a feeling of sharp pain to encourage
you to quickly move away from a harmful stimulus such as a broken
piece of glass or a hot stove stop. They also have receptors that
cause a dull pain in an area that has been injured to encourage you
not to use or touch that limb or body part until the damaged area
has healed. While it is never fun to activate these receptors that
cause pain, these receptors play an important part in keeping the
body safe from serious injury or damage by sending these early
warning signals to the brain.
[0032] Another receptor type are proprioceptors, the word
"proprius" means "one's own" and is used in the name of these
receptors because they sense the position of the different parts of
the body in relation to each other and the surrounding environment.
Proprioceptors are found in tendons, muscles, and joint capsules.
This location in the body allows these special cells to detect
changes in muscle length and muscle tension. Without
proprioceptors, we would not be able to do fundamental things such
as feeding or clothing ourselves.
[0033] While many receptors have specific functions to help us
perceive different touch sensations, almost never is just one type
active at any one time. When drinking from a freshly opened can of
soda, your hand can perceive many different sensations just by
holding it. Thermoreceptors are sensing that the can is much colder
than the surrounding air, while the mechanoreceptors in your
fingers are feeling the smoothness of the can and the small
fluttering sensations inside the can caused by the carbon dioxide
bubbles rising to the surface of the soda. Mechanoreceptors located
deeper in your hand can sense that your hand is stretching around
the can, that pressure is being exerted to hold the can, and that
your hand is grasping the can. Proprioceptors are also sensing the
hand stretching as well as how the hand and fingers are holding the
can in relation to each other and the rest of the body.
[0034] None of the sensations described above and felt by the
somatosensory system would make any difference if these sensations
could not reach the brain. The nervous system of the body takes up
this important task. Neurons, which are specialized nerve cells
that are the smallest unit of the nervous system, receive and
transmit messages with other neurons so that messages can be sent
to and from the brain. This allows the brain to communicate with
the body. When your hand touches an object, the mechanoreceptors in
the skin are activated, and they start a chain of events by
signaling to the nearest neuron that they touched something. This
neuron then transmits this message to the next neuron which gets
passed on to the next neuron and on it goes until the message is
sent to the brain. Now the brain can process what your hand touched
and send messages back to your hand via this same pathway to let
the hand know if the brain wants more information about the object
it is touching or if the hand should stop touching it.
[0035] Vibration experiments have been conducted to test the
effects of vibration, the results of such an experiment were
published in 1961 in the Journal of Physiol. (1961), 159 pp
391-409, entitled "Response of Pacinian Corpuscles to Sinousoidal
Vibration, by M. Sato. In this experiment it was proven that
vibrations can excite the nervous system similar to utilization of
electrical stimulation.
[0036] Other experiments have shown that the 1st Node of Ranvier
gaps can be excited by either mechanical transduction or acoustic
stimulation. The 1st Node of Ranvier gaps are gaps formed between
myelin sheaths between different cells.
[0037] In a 1967 publication entitled "The Relative Sensitivity to
Vibration of Muscle Receptors of the Cat," M. C. Brown, I.
Engberger and P. B. C. Matthews, Journal Physiol. (1967), 192 PP
773-800, the authors tested vibrations and concluded that vibratory
effects persist as long as the vibration continues. Additionally,
the authors cited another publication, 1966 Matthews, "Reflex
excitation of the soleus muscle of the decerebrate cat caused by
vibration applied to tendon" where vibration, was applied to a
non-contracting muscle, provides a way of selectively activating
nearly all of the nerve fibers from the primary endings to
discharge repetitively. In contrast to electrical stimulation,
vibration provides for a more selective activation.
[0038] Electrical stimulation will stimulate those nerves which are
located in the close proximity to the electrical source, however,
electrical stimulation will seek the lowest resistance pathway and
is typically localized to the area of application. In contrast,
vibrational stimulation carries the benefit of exciting afferent
fibers at a distance from the location of the application of the
vibration.
[0039] In 2000 a publication by Alfrey entitled "Characterizing the
Afferent Limb of the Baroreflex" Rice University, Houston Tex.,
April 2000, UMI Microform 99-69-223. The author concluded that the
baroreflex is the fastest autonomic reflex responding to changes in
blood pressure. Baroreceptor nerve endings embedded in vessels
throughout the circulatory system encode both mean pressure and
rate of change of pressure as a frequency-modulated train of action
potentials (spikes). Centers in the brainstem process the spike
train information, integrating it with information from higher
centers and providing a signal to the sinoatrial (SA) pacemaking
node of the heart via efferent fibers in the vagus nerve. When
blood pressure becomes too high, the resulting vagal signal
triggers the release of acetylcholine at the SA node of the heart
slowing heart rate and thus lowering blood pressure.
[0040] In another paper, published in 2004 by Syntichaki et al.,
entitled "Genetic Models of Mechanotransduction: The Nematode
Caenorhabditis elegans" Physol Rev. 84: 1097-1153, 2004
10.1152/physrev.0043.2003, it was found that all vertebrates
respond to similar mechanosensory stimuli, therefore it's likely
that two humans would have similar response to the same wavelengths
or frequencies.
[0041] Lastly, while there are number of different therapies
available on the market and new therapies emerging, there are
patient populations that cannot be treated through the use of the
existing drugs or devices.
[0042] One such population is patients who develop high blood
pressure during pregnancy. Health care practitioners are generally
hesitant to prescribed pharmaceutical products in these situations
as there may be unknown side effects to the mother and unborn
child. Furthermore, many hypertensive pharmaceutical products have
not been properly tested for use during pregnancy; therefore, there
is much hesitancy on behalf of the prescribing physician to use
such drug products due to potential untested side-effects as well
as potential litigation arising from a side-effect. Pregnancy
induced hypertension, gestational hypertension or preeclampsia may
not be a permanent condition and may be resolve after delivery.
Therefore, the use of permanent therapies, such as renal
denervation, may not be warranted in this situation. Additionally,
surgical procedures are not generally recommended during
pregnancy.
[0043] There is yet another hypertensive population emerging in
today's world is the hypertensive adolescent. Over the past 30
years, the number of adolescent hypertensives has risen to a rate
of over 3.7% diagnosed hypertensive and 3.4% diagnosed
pre-hypertensive. Only 1 in 4 adolescents are currently diagnosed.
Many of the currently available pharmaceutical products have not
been tested on an adolescent population, therefore, as described
above, many physicians are hesitant to prescribe drug therapies due
to unknown side effects or long term effects they may have.
Furthermore, the adolescent population poses yet another difficulty
in that they are still developing and undergoing puberty and bone
growth. Therefore, there is a need for a non-invasive,
non-pharmaceutical solution to address this growing patient
population.
[0044] Thus, it would be desirable to provide improved methods,
devices and systems for artificial and selective activation of a
patient's baroreflex or nervous system in order to achieve a
variety of therapeutic objectives, including the control of
hypertension, renal function, heart failure, and the treatment of
other cardiovascular disorders. It would be particularly desirable
if such methods and systems were non-invasive, reversible, safe
and/or external to the patient.
BRIEF DESCRIPTION OF THE INVENTION
[0045] In accordance with the present invention there is provided a
device for treatment of hypertension, comprising, a housing, the
housing have a proximal end and a distal end; and a driver assembly
within the housing, the driver assembly electrically coupled to an
energy source, the energy source disposed within the housing.
[0046] In accordance with the present invention there is provided a
device for imparting energy to a patient, comprising, a housing,
the housing having a proximal end, a distal end and defining a
volume therebetween; a driver assembly is disposed within the
volume of the housing; an energy source coupled to the driver
assembly; and an electronics module coupled to the driver assembly
and the energy source, wherein the electronics module controls the
driver assembly.
[0047] In accordance with the present invention there is provided a
device for treating hypertension, the device comprising, a housing,
the housing having a proximal surface and a distal surface, wherein
the housing further includes a mounting system, the mounting system
including a first member and a second member, the first member
associated with the housing and the second member configured to be
received by tissue; and a driver assembly within the housing.
[0048] In accordance with the present invention this is provided a
device for imparting energy to a patient, the device comprising: a
housing, the housing having a first surface and a second surface,
the surfaces defining a volume therebetween, wherein the housing
further includes a mounting system, the mounting system including a
first member and a second member, the first member associated with
the housing and the second member configured to be received by
tissue; a driver assembly disposed within the volume of the
housing; an energy source coupled to the driver assembly; and an
electronics module coupled to the driver assembly and the energy
source.
[0049] In accordance with the present invention there is provided a
method of providing therapy, the method comprising: applying a
therapy applying device to a collar bone of a patient; and
activating a driver assembly within the therapy applying
device.
BRIEF DESCRIPTION OF THE DRAWINGS
[0050] FIG. 1 is an exemplary embodiment of the therapy system in
accordance with the present invention;
[0051] FIG. 2 is a isometric view of a therapy providing device in
accordance with the present invention;
[0052] FIGS. 3A-3D are exemplary illustrations of housings of the
therapy providing device in accordance with the present
invention;
[0053] FIG. 4A is a top view of a housing of the therapy providing
device in accordance with the present invention;
[0054] FIG. 4B is a cross-sectional view of the housing of FIG. 4A
taken about line B-B;
[0055] FIG. 4C is a cross-sectional view of another housing in
accordance with the present invention;
[0056] FIG. 5 is an exploded view of a therapy providing device in
accordance with the present invention;
[0057] FIG. 6 is an isometric view of a circuit board in accordance
with the present invention;
[0058] FIG. 7 is a plan view of a haptic speaker in accordance with
the present invention;
[0059] FIG. 8 is an isometric view of an electroactive polymer
transducer in accordance with the present invention;
[0060] FIG. 9 illustrates a cross-sectional view of the
electroactive polymer transducer of FIG. 8 in communication with a
driver;
[0061] FIG. 10 is a plan view of an alternative embodiment of an
electroactive polymer transducer in accordance with the present
invention;
[0062] FIG. 11 is an isometric view of a charging/base station in
accordance with the present invention;
[0063] FIG. 12 is a side view of the therapy providing device of
the present invention in combination with a CPAP mask assembly;
[0064] FIG. 13A is a bottom view illustrating a therapy device
including an adhesive mounting system;
[0065] FIG. 13B illustrates the therapy device of FIG. 13A as
disposed on a user;
[0066] FIGS. 14A and 14B illustrates and alternative mounting
arrangement for the therapy device of the present invention;
[0067] FIG. 14C is a cross-sectional view of the mounting system of
FIGS. 14A and 14B;
[0068] FIGS. 15A and 15B illustrate another mounting arrangement
for the therapy device of the present invention;
[0069] FIGS. 16A and 16B illustrate a magnetic mounting system in
accordance with the present invention;
[0070] FIGS. 17 and 18 illustrate embodiments of support structures
for use with the present invention;
[0071] FIGS. 19A-19C illustrates another housing in accordance with
the present invention, the housing configured to be received about
a user's shoulders;
[0072] FIGS. 20A and 20B illustrate alternative clothing mounting
arrangements for the therapy device of the present invention;
[0073] FIG. 21A illustrates an exemplary embodiment of a computing
device in accordance with the present invention;
[0074] FIG. 21B illustrates and exemplary screen view of a program
displayed on the exemplary computing device of FIG. 21A in
accordance with the present invention;
[0075] FIG. 22 illustrates a flow diagram for a software program in
accordance with the present invention;
[0076] FIG. 23A illustrates a therapeutic frequency curve for the
therapy provided by an exemplary embodiment of the present
invention;
[0077] FIG. 23B illustrates a timed therapy sequence in accordance
with an embodiment of the present invention;
[0078] FIG. 24A illustrates a patient's blood pressure reading over
a twenty-four hour period, showing a hypertensive patient; and
[0079] FIG. 24B illustrates the blood pressure of the patient of
FIG. 24A after receiving therapy in accordance with the device and
methods of the present invention.
DETAILED DESCRIPTION OF THE INVENTION
[0080] The following detailed description illustrates embodiments
of the invention by way of example and not by way of limitation.
The description clearly enables one skilled in the art to make and
use the disclosure, describes several embodiments, adaptations,
variations, alternatives, and uses of the disclosure, including
what is presently believed to be the best mode of carrying out the
disclosure.
[0081] This written description uses examples to disclose the
invention, including the best mode, and also to enable any person
skilled in the art to practice the invention, including making and
using any devices or systems and performing any incorporated
methods. The patentable scope of the invention is defined by the
claims, and may include other examples that occur to those skilled
in the art. Such other examples are intended to be within the scope
of the claims if they have structural elements that do not differ
from the literal language of the claims, or if they include
equivalent structural elements with insubstantial differences from
the literal languages of the claims.
[0082] In accordance with the present invention there is provided
devices and methods for the treatment of hypertension. The device
of the present invention is configured to be detachably attached to
a user, wherein the device is aligned with a bone of the user's
body. Once affixed to the patient, the device can be activated
either manually or remotely, wirelessly or wired, through the use
of a software program running on a computing device or a software
program within the device. The activation may be timed to coincide
with a patient's sleep pattern, such that therapy is provided by
the device to the patient in the evening and again in the morning
prior to the patient waking up. It is believed that providing
therapy during a sleep cycle is beneficial.
[0083] In accordance with embodiments of the present invention the
device is detachably attached to a patient's tissue and is intended
to engage a portion of the patient's skeletal frame, particularly
the clavicle. It shall be understood that although the present
invention is described in reference to the collar bone or clavicle,
it shall be understood that this should not be limiting in any
manner. As described above, in a preferred embodiment the methods
and devices of the present invention utilize the clavicle. However,
the methods and devices of the present invention may be utilized
with other dermal bones such as the skull, jawbone, knee cap
(patella) or non-dermal bones such as the wrist bone, ribs,
scapula. Methods and devices of the present invention can also be
used above any portion of the body containing somatory sensors such
as proprioceptors, nociceptors, mechanoreceptors or
thermoreceptors. Dermal bones are unique in that dermal bone does
not form from cartilage first and then calcify. Dermal bone is
formed within the dermis and it grows by accretion only; that is,
the outer portion of the bone is deposited by osteocytes. Dermal
bones have been utilized to transmit sound for other devices such
as in hearing aids.
[0084] Referring now to FIG. 1, there is shown the therapy system
100 in accordance with the present invention. As shown in FIG. 1,
the therapy system 100 in accordance with the present invention may
include a pair of therapy providing devices 200 and optionally a
computing device 300. The therapy providing system 100 may further
include a charging/storage system as will be described in detail
below with reference to FIG. 11. Additionally, the therapy
providing device 200 may further include an integrated or separate
attachment system to detachably attach the system 100 to a user's
skin as will be described in greater detail below.
[0085] As shown in FIG. 1, the computing device 300 in one aspect
is configured to communicate with the therapy providing device 200
through a wireless communication protocol such as through the use
of wifi, Bluetooth, ZigBee, RFID, NFC, ANT+, cellular, infrared or
other known wireless communication protocols. Alternatively, the
computing device 300 and the therapy providing devices 200 may be
communicatively coupled together using a physical connection such
as an electrical wire, a plurality of electrical wires, electrical
cable, fiber optic or using other known physical connections
capable of transmitting signals between the devices. As shown in
FIG. 1, it is contemplated that the methods of use in accordance
with the present invention would utilize two therapy providing
devices 200 as shown. If two therapy providing devices 200 are
utilized, they are intended to be disposed on a user about the left
and right clavicle. In accordance with the present invention a
single therapy providing device 200 may be utilized for treatment
according to the present invention, or multiple therapy providing
devices 200 may be utilized for therapy. The two therapy providing
devices 200 can be communicatively coupled together utilizing a
physical connection or a wireless connection such as those
described above.
[0086] Referring now to FIG. 2, there is shown an isometric view of
a therapy providing device 200. As shown in FIG. 2, the therapy
providing device 200 includes a housing 210. The housing 210
defined by a proximal end 212 and a distal end 211, and first
surface 214 and a second surface 215 (not shown), the proximal end,
distal end and first and second surfaces and defining a volume
therebetween, wherein the volume includes additional structures and
components as will be described below. As shown in FIG. 2, the
first surface 214 includes a power button 260, a LED indicator
light 262, and at least one pair of charging pins 265. The multiple
charging pins 265 may be including on the therapy providing device
200, whereas the multiple pins 265 are disposed symmetrically about
an axis (not shown) passing through the power button 260. Placement
of the charging pins 265 about an axis extending through the power
button 260 allows for the therapy providing device 200 to be placed
within a charger without care as to orientation as each side of the
therapy providing device 200 includes charging pins 265, such that
the therapy providing device 200 will engage the changing pins in
the charging station in either orientation. Additional details with
regard to a charging station/base will be described in greater
detail below with reference to FIG. 11. Additionally, the housing
201 may further include magnets 230 or a metallic material disposed
within recesses formed in the first and second ends 211,212 of the
housing 210. Alternatively, the magnets 230 may be integrally
formed with the housing 210 during a manufacturing process such as
injection molding.
[0087] The housing 210 may be formed of multiple pieces which may
then be assembled using known assembly methods such as glue,
ultrasonic welding, heat welding, rotational welding, snap-fit
construction, use of fasteners such as screws or pins, or the like.
In accordance with the invention, the housing 210 may be formed of
two pieces or multiple pieces, wherein one section of the housing
210 includes all sides except the second surface 215, thereby
forming a shell into which the components can be disposed, then the
second surface 215 could be attached to the other portion of the
housing 210 to form the therapy providing device 200. The housing
210 may be constructed of biocompatible materials such as polymers,
plastics, fabrics or metals. The housing 210 may be formed using
manufacturing processes such as machining, injection molding, 3-d
printing, vacuum forming, deep drawing or the like. In accordance
with the invention, the materials utilized in construction of the
housing 210 of the therapy providing device 200 shall be chosen
such that the materials have good biocompatibility as it is
intended that the therapy providing device 200 will be placed in
skin contact during use, where in certain usages the skin contact
may be for prolonged time.
[0088] Further still, it is contemplated that the therapy providing
device 200 may be wrapped with a biocompatible membrane. An example
of a suitable membrane is available from 3M and sold under the
tradename of Tegaderm.
[0089] Referring now to FIGS. 3A-3D there are shown exemplary
embodiment of the second surface 215 in accordance with the present
invention. As shown in FIG. 3A, the second surface 215 may be
formed as a planar surface. Referring now to FIG. 3B, in this
figure, the second surface 215 is formed of multiple pieces,
wherein one component 216 is configured to be received by the other
portion of the housing and the second component 217 is configured
to be received by a user's tissue, this portion 217 may be formed
of a more pliable or conformable material than the first component
215, wherein the more pliable material 217 may conform or shape to
the user's anatomy more readily. In accordance with the invention,
the second component 217 may be formed of a compliant material such
as and open or closed cell foam material, such that when the
therapy providing device 200 is disposed upon a user for therapy,
the compliant foam surface conforms to the user's anatomy.
Additionally, the materials selected may be chosen such that they
are anti-microbial/bacterial.
[0090] Referring now to FIGS. 3C and 3D there is shown another
exemplary embodiment wherein the second surface 218 is shown having
a first thickness, wherein the material of which the first surface
218 is formed is selected such that the material may be shaped or
contoured to be received by a patient's skin, particularly in an
area adjacent the patient's clavicle. The shaped surface may be in
the form of a concave shape. Further still, the material 218 of
FIGS. 3C and 3D may be selected such that the material defines a
deformable structure, such that when the housing is placed over the
patient's clavicle the housing conforms to the patient's anatomy as
shown in FIG. 3D. In yet another embodiment, a portion of the
housing may be custom formed to each individual user through the
application of heat, whereby the housing or a portion of the
housing is heated and then pressed onto the patient, the heated
portion of the housing conforming to the patient's anatomy, or
heated and molded by through an application of force. In another
aspect, the second component 217 may be embodied in the form of a
flexible membrane in which an expandable foam material may be
injected into. In use, the therapy providing device would be placed
on the user in a chosen location, the expandable foam material
could then be injected into the flexible membrane while the therapy
providing device is held against the user. As the foam expands and
cures, the second component 217 would take the shape of the user's
anatomy, thereby providing a customized fit. Lastly, it is further
contemplated that the housing includes an enlarged or thickened
surface that can be ground or machined away to conform to the
patient's anatomy. Further still, a mold may be taken of the
patient's anatomy, whereby a housing can then be manufactured from
the mold taken from the user's anatomy, thereby customizing the fit
of the therapy providing device to each user.
[0091] Referring now to FIGS. 4A-C there are shown additional
housing designs in accordance with the present invention. As shown
in FIG. 4A the alternative housing is formed in a generally
circular fashion, wherein the housing contains additional
components as will be described in greater detail below. Also as
shown in FIG. 4A, the housing 270 may further include a wire or
cable connection extending from the housing 270 as described above.
Referring now to FIG. 4B, there is shown a cross-sectional view of
the housing 270 of the therapy providing device 200'' of FIG. 4A
taken about line B-B of FIG. 4A. As shown in the cross-sectional
view, the alternative housing 270 is formed having a generally
convex shape. Referring now to FIG. 4C there is shown a
cross-sectional view of yet another alternative embodiment of a
housing 272, in this embodiment the housing 272 has a generally
convex shape as previously described, however, in this embodiment
the housing 272 includes concave portions 271. In use, the housing
272 is placed on a user, adjacent to the user's clavicle, wherein a
force can be applied to the housing 272 adjacent to each concave
portion 271 forcing air out of the concave portions 271, thereby
causing a vacuum to be formed thereby suctioning the housing 272 to
the user's tissue. It is contemplated that the housings 270 and 272
shown in FIGS. 4A-4C may be constructed of a biocompatible flexible
material, such that the housing conforms to the user's anatomy when
placed thereupon. Examples of suitable materials of which the
housings 270, 272 may be formed from are: silicone, urethanes,
rubber, silicone, latex and the like.
[0092] Referring now to FIG. 5, there is shown an exploded view of
a therapy providing device 200 in accordance with the present
invention. As described above and shown in FIG. 2-4, the therapy
providing device includes a housing 210, wherein the housing
includes provisions for a power switch 260 as well as provisions
for LED indicators 262 and charging pins 265 as described above.
The power switch 260 maybe a separate component disposed within the
housing 210 or it may be embodied as a reduced thickness portion
(not shown) of the housing 210 which can be formed to project
slightly above the first surface 214 of the housing 210, whereby in
use, a user can apply a light force to the raised portion to active
a switch disposed beneath the raised portion. Forming a raised
portion integral to the first surface of the housing 210 to be
utilized as a switch simplifies construction, eliminates additional
components, this construction also eliminates the need to form a
hole within the first surface of the housing which may require
sealing against liquids. Further, the provisions for the LED 262
and the charging pins 265 may be in the form of openings formed
within the housing to receive such items. Alternatively, the LED
262 provision may be embodied in the form of an opaque or clear
section within the housing 210 during manufacture to allow light to
project therethrough from a LED 503 mounted on a circuit board 500
disposed below the housing 210. Additionally, it is contemplated
that the charging pins 265 may also be integrally formed during the
manufacture of the housing 210. For example, if the housing 210 is
manufactured using an injection molding process, the charging pins
265 could be disposed within the injection mold as an insert,
whereby the charging pins 265 would be captured in the housing 210
during the molding process. Alternatively, the housing 210 can
include openings for charging pins 265 to project through. Further
still, the housing 210 may include openings having tapered wall
portions, forming pockets within the first surface 214, thereby
providing access to charging pads/pins 504 disposed on a circuit
board 500 disposed below the first surface 214 of the housing 210.
The housing 210 may further include an indentation 229 formed
therein or a plurality of indentations 229, allowing a user to
grasp the housing 210.
[0093] As shown in FIG. 5, the therapy device 200 further includes
a first circuit board 500 and a second circuit board 550. The first
circuit board 500 is disposed adjacent to the first surface 214 of
the housing 210, wherein the first circuit board 500 includes a
power switch component 502, at least one indicator LED 503
configured to indicate the power status of the therapy providing
device 200. The first circuit board 500 further includes charging
pins/pads 504, wherein the charging pins/pads may be configured to
project through the housing 210 as described above, or
alternatively, the housing 210 may include openings formed therein
to access the charging pins/pads 504. The power switch 502 may be
embodied as a physical switch, such as a slide switch, or may be
embodied as a touch sensitive or capacitive sensitive switch, or
may be embodied as a pressure sensitive switch. The first circuit
board 500 further includes a connector (not shown) which is
configured to electrically connect the first and second circuit
boards. The connector may be embodied as solder holes in which
wires can be disposed into or may be embodied in the form of a plug
or header assemble, wherein the plug/header are configured to
accept a cable, wire, ribbon cable or a flexible pcb to facilitate
electrical communication between the boards. The first and second
circuit boards may be constructed of known materials and methods,
whereby the boards may be hard rigid board assemblies or may be
constructed using flexible board manufacturing technologies.
Although, it is described above that the present invention utilizes
two circuit boards, this should not be considered limiting in any
manner, it is contemplated that the electronic components of the
present invention may be embodied on a single circuit board or on
multiple circuit boards.
[0094] As shown in FIG. 5, disposed below the first circuit board
500 is an energy source 240. The energy source 240 may be in the
form of a battery pack. The battery pack may be a rechargeable pack
or a single use pack which may be embodied as gel batteries or
absorbed glass mat batteries. Suitable examples of batteries that
may comprise the pack are lithium ion (Li-ion), lead-acid,
nickel-cadmium (NiCd), nickel-zinc (NiZn), zinc-oxide, nickel metal
hydride (NiMH), Lithium ferrous-oxide (LiFo) or other known battery
technologies. It is further contemplated that instead of utilizing
a battery for an energy source a capacitor and related circuitry
could be utilized.
[0095] In the event that the energy source 240 is embodied as a
battery pack, the battery pack may be embodied in the form of a
fabricated pack, where individual cells are soldered together, or
alternatively, the battery pack could be arranged to utilize
conventional battery sizes such as AAA, AA, CR2032, LR44, 9-volt,
A23 and the like.
[0096] It is further contemplated that the battery pack may be
further divided into a primary battery pack and a backup battery
pack. In use, the primary battery would be initially utilized, if
the pack malfunctions or loses its charge or its charge is used,
the backup battery pack would then be enabled to continue the
therapy.
[0097] If the battery pack as described above is chosen to be a
rechargeable, there is a need to provide a charging circuit within
the circuit boards 500 or 550. The charging circuit may utilize
either a physical connection to enable charging or may use a
non-contact or inductive charging arrangement. If a physical
connection is utilized, the plug may be a USB style plug, headphone
style, spring loaded pins/contact pads or other types of plugs,
such a plug can be integrated into the housing 210 and electrically
connected to the battery through either circuit board.
Alternatively, a plug may be directly mounted onto one of the
circuit boards. It is further contemplated that the charging plug
can also be utilized both for charging as well as communication
between multiple therapy providing devices 200 or the computing
module 300 as described above using a compatible cable.
[0098] As described above, the present invention may utilize pins
or pads disposed on or coupled to the first circuit board to enable
charging of the battery disposed within the device. It is further
contemplated that a non-contact charging assembly could be utilized
with the present invention. If a non-contact charging arrangement
is selected, then the charging pins 265 and/or openings within the
first surface of the housing 210 may not be necessary. Instead, the
therapy providing device 200 would include a charging coil (not
shown) disposed about the perimeter of the first circuit board 500.
The use of a non-contact charging coil would further necessitate
the inclusion of additional integrated circuits to enable and
control the charging function. These additional circuits can be
disposed on either of the two circuit boards. Suitable examples of
a non-conductive or inductive charging would utilize an
electromagnetic field to transfer energy between the charger and
the battery pack. In this embodiment a charging station would be
provided in which the therapy providing device 200 could be stored
and charged simultaneously as will be described below. It is also
contemplated that the storage/charging container may be a smart
container that is it may contain a microprocessor and/or a wireless
communication chipset. Thus, once the therapy device is removed
from the storage container, the integrated wireless chipset within
the storage container may cause the therapy device to power on.
Suitable examples of components to enable non-contact charging are
available from Wurth Electronics Inc., part numbers 760308201
wireless charging receiving coil and 760308101 wireless charging
transmitting coil.
[0099] In accordance with the present invention, it is contemplated
that the energy source 240 may be embodied in the form of an
integrated generator, wherein the generator would be configured to
create energy from movement of the therapy providing device 200,
much like and automatic watch movement.
[0100] As described above, the therapy providing device 200 shown
in FIG. 5 includes two circuit boards, 500 and 550. The circuit
board 500 having been previously described above. Referring now to
FIGS. 5 and 6 there are shown exemplary embodiments of the circuit
board 550 in accordance with the therapy providing device 200 of
the present invention. As described above, the second circuit board
550 is configured to be coupled with the first circuit board 500,
wherein components may be disposed on either of the two boards and
interconnected through an appropriate connection as previously
described using a header or solder holes formed in the circuit
board 550. Referring now to FIG. 6, there is shown a general
schematic of the second circuit board 550, wherein the second
circuit board 500 includes a processor 551, optional memory chip
552, an audio amplification circuit 553 and a communication port
554. The communication port 554 may embodied as a physical port
such as a mini-usb, micro-usb, firewire, thunderbolt or other known
similar communication ports. The audio amplification circuit 553
may include one or two audio amplifiers, wherein the incoming
signal from the processor 551 is amplified such that the amplified
signal can then be connected to a driver assembly 220 as described
below. As shown in FIGS. 5 and 6, the second circuit board 550 may
be shaped to be received within a shaped housing. As shown in FIGS.
5 and 6, the second circuit board is shown having an elliptical
shape with an aperture formed through the center thereof. The
aperture can be sized to receive a portion of the driver assembly
220, thereby allowing the overall size of the device to be reduced
by allowing components to `nest` when assembled. The second circuit
board 550 may contain additional electronic components such as
audio filters, booster circuits, timing circuit and data logging
capability. In accordance with the present invention, the processor
551 may be sourced from CSR PLC, Churchill House, Cambridge
Business Park, Cowley Road, Cambridge, CB4 0WZ Churchill House,
Cambridge Business Park, Cowley Road, Cambridge, CB4 0WZ, having
part number 8670.
[0101] The second circuit board 550 may further include a
communications chipset (not shown) such: Bluetooth, wifi, ZigBee,
RFID, NFC, Ant+, infrared, 3G/4G, CDMA, TDMA or other known
wireless communication protocols.
[0102] The first or second circuit board 500/550 may further
include a clock circuit (not shown). The clock circuit generates
and sets the timing of operations performing within the therapy
providing device 200. The clock generator may be utilized to
activate the therapy providing device 200, or may be utilized to
record timed events, such as when the therapy providing device is
on or off or in use.
[0103] Further still, either circuit board 500/550 may
alternatively include an impedance sensor or pair of impedance
sensors, the impedance sensors in association with the processor
551 can be used to determine if the housing 210 is coupled to a
user's skin or if the housing is not coupled to the skin. If the
housing 210 is coupled to a user's skin, then the impedance sensor
would provide a signal to the processor 551 indicating such a
condition, thereby the program stored in the memory of the
processor or transmitted to the microprocessor could be initiated
to conduct therapy according to the invention. If the impedance
sensor is not coupled to the user's skin, then an open condition
would occur, whereby the program would not be initiated and a
visual signal may be generated through the program/processor to
alert the user that the therapy providing device 200 is not placed
properly and needs to be repositioned.
[0104] In yet another embodiment, the electronics module may
include a microphone, whereby a test signal can be initiated and
delivered by the driver assembly 220 or other audio/vibration
device. The microphone would be utilized by the processor 551 to
listen for a reflection of the test signal off of the user's
clavicle, skin or other bone or structure to determine if the
therapy providing device 200 has been placed properly. If the
reflected sound matches that of one stored in memory, then the
program can be run to provide therapy. If the reflected sound does
not match the sound stored in memory, then an error message would
be generated. The error message may be in the form of an audio
signal or in the form of a visual signal such as a blinking light
or a series of blinking lights.
[0105] Additionally, the microphone could be coupled with a blood
pressure monitor, wherein the microphone would listen for Korotkoff
sounds, whereby the data generated from the blood pressure monitor
and specifically the Korotkoff sounds captured by the microphone
can be utilized to enable a closed loop control system or closed
loop feedback system. It is contemplated, that the therapy provided
by the therapy providing device 200 can be dynamically modified in
response to the data received from the microphone coupled to the
processor 551.
[0106] The circuit board 500 or 550 may further incorporate a
pressure sensitive switch coupled to the processor 551. In use, the
pressure sensitive switch would be in a normally open position or
off position. When the therapy providing device 200 is placed on
the user's skin, the pressure sensitive switch would be depressed,
thereby turning the therapy providing device 200 on. The actuation
of the switch can also be associated with the clock circuit to
associate a time with the on/off state of the switch. These events
can be written to the memory of the processor 551 or other memory
storage location. The data can then be transmitted, wired or
wirelessly, to a personal computer for analysis/storage. By
tracking the actual on/off time of the therapy providing device,
user compliance may be tracked by the user or by a third party such
as a health care provider.
[0107] In yet another embodiment, the circuit board 500 or 550 may
include an optical sensor, wherein the optical sensor is utilized
to detect whether the therapy providing device is affixed to a
user's skin. In this embodiment, the optical sensor can include a
light sensor, whereby when the therapy providing device 200 is
affixed to the user's skin the light is blocked to the sensor. In
another embodiment, the optical sensor can be a reflective sensor,
wherein the color of the light reflected back indicates whether the
device is affixed to a user's skin or not.
[0108] In another aspect of the present invention, the light sensor
may be utilized to monitoring blood oxygen level, wherein data
received from monitoring the user's blood oxygen level can be
stored in memory or transmitted to another device such as a
pulse-oximetry monitor or another computing device. Further still,
the blood oxygen data may be utilized by a program of the therapy
providing device to alter therapy provided to the user or otherwise
control the therapy providing device 200.
[0109] In another aspect of the present invention, the light sensor
may be used to measure alteration in blood-reflectance color,
whereby the program controlling the therapy providing device may
utilize this signal as a representation of heart rate or heartbeat.
Accordingly the program controlling the therapy providing device
200 may use this data to determine blood pressure and accordingly
provide therapy to the user based on the received data.
[0110] It is further contemplated, that an accelerometer and/or
compass and/or tilt sensor and/or GPS sensor can be incorporated
into either of the circuit boards described above. The inclusion of
such a sensor can be utilized to determine the position and/or
orientation of the device. In use, as described below, a user would
affix the housing 210 to their person using an adhesive patch,
harness, specialized clothing article as will be described below.
In this embodiment, the accelerometer/compass in communication with
the processor 551 can be utilized to determine when to activate the
therapy providing device or devices 200. If the signal coming back
from the accelerometer/compass/tilt sensor indicates that a therapy
providing device 200 is in a vertical position, then the program
contained within the memory of the processor 551 or computing
device 800 would not be initiated. Once the signal from the
accelerometer/compass/tilt/GPS sensor indicates that the user is in
a prone position, likely a sleep position, then the program
contained within the memory can be run. Additionally, the clock
timer can be associated with the accelerometer/compass/tilt/GPS
sensor such that a user's sleep pattern can be stored in memory of
the processor 551 or computing device 800. Data generated from such
sensors could be stored in memory, of either the therapy providing
device or the computing device to track usage of the device as well
as the physical location of the devices. Such data could be
transmitted to a third party using know wireless communication
methods.
[0111] The circuit boards or the housing or therapy providing
device 200 may be provided with a unique identifier such as a
serial number or patient information identifier so that the therapy
providing device 200 may be tracked. Additionally, using the unique
identifier it may be possible for a physician or a user to utilize
a computer program, such as a website which when placed in
communication with the therapy providing device, either wired or
wirelessly, would allow continuous monitoring of usage of the
device, such as date and time monitoring, duration of use, patient
compliance and the like. The website could also provide information
regarding hypertension and additionally be configured to
communicate with other devices such as a scale to track the user's
weight, a blood pressure monitor to track blood pressure
measurements, a glucose meter, a heart rate monitor or other
fitness tracking device such as Fitbit or BodyBug. Each of these
devices would be interfaced with the website, such that data
collected from these devices could be uploaded to the website where
the data could be presented to the user or alternatively, the data
could be shared with anyone that the users chooses to do so. For
example, the user may desire to share the data with their health
care provider, dietician or other individual(s).
[0112] In accordance with the invention, it is contemplated that
one or both circuit boards along with the battery may be housed
within a separate housing from the therapy providing device 200. In
this embodiment, the circuit board(s) and battery would be coupled
to the therapy providing device either through a cable connection
or through a wireless connection. If a wireless connection is
utilized, then the therapy providing device would include the
necessary electronics disposed within its housing to facilitate the
communication between the electronics module and the therapy
providing device as well as a power source such as the battery.
[0113] Referring to FIG. 5, disposed below the second circuit board
550 is a driver assembly 220. The driver assembly 220 is disposed
within the volume 213 of the housing 210. The driver assembly may
comprise a conventional coil speaker, an ultrasonic generator, a
piezoelectric speaker, a haptic speaker, a pneumatic device, a
suction device, a mechanical vibratory device, a hydraulic
actuation device, or a photo-acoustic excitation device. Examples
of drivers assemblies 220 that can be used with the present
invention may be purchased from HiWave Technologies PLC, Regus
House, 1010 Cambourne Business Park, Cambourne, Cambridge CB23 6DP
United Kingdom. Referring now to FIG. 7 there is shown an exemplary
haptic speaker or haptic exciter 220' which may be utilized with
the therapy providing device 200 of the present invention. As shown
in FIG. 7, the haptic speaker 220' includes a frame member 221, a
voice coil 222 and a plurality of flexible members 223.
Additionally, the haptic speaker 220' includes electrical
connections 224, thereby allowing the haptic speaker 220' to be
electrically connected to the audio amplifier circuit as previously
described. In use, the flexible members 223 allow the voice coil
222 of the haptic speaker 220' to translate relative to the frame
221, thereby producing sound or movement.
[0114] In yet another embodiment, the driver assembly 220 may be
embodied as an electroactive polymer transducer 315 as shown in
FIGS. 8-10. Electroactive polymer transducers are made up of a
first thin elastic polymer 320, which is also referred to as a film
or membrane, this is sandwiched between compliant electrodes 340
and 345. When voltage is applied across the electrodes, the unlike
charges in the two electrodes are attracted to each other, these
electrostatic attractive forces compress the polymer film 320
(along the z-axis). The repulsive forces between like charges in
each electrode stretch the film in the plane (along the X and Y
axis'). As the transducer 315 deflects, the deflection can be
utilized to perform work. In the present invention, the work that
is performed is the development of vibrations, wherein the
vibrations being developed by the transducer 315 are developed
within a certain frequency range as will be discussed in greater
detail below. Additional information regarding electrostatic
transducers can be found in U.S. Pat. No. 7,898,159 and U.S. Pat.
No. 7,608,989, the entireties of which are hereby incorporated by
reference.
[0115] It is further contemplated that the transducer 315 as
described above may be further coupled to another assembly, wherein
the other assembly would have an increased mass. Through use, the
transducer would be activated by providing a voltage to the
electrodes, thereby exciting the polymer, wherein the weighted
assembly would be excited thereby delivering greater vibrational
energy.
[0116] In accordance with another aspect of the present invention,
the electroactive polymer transducer 315 can be formed to have a
curved shape, or be attached to a housing having a curved shape,
such that the housing or curved excited can be readily received by
a user's anatomy, specifically the user's clavicle or
collarbone.
[0117] The electroactive polymer transducer 315 of the present
invention may be embodied in different geometric shapes. It is
contemplated that the transducer 315 may be embodied in the form a
circular shape, oblong shape, square, rectangular or other known
geometric shapes. Further still, it is contemplated that the
transducer may be formed with at least one bar-arm type of
arrangement as shown in FIG. 3D. In this embodiment, the bar-arm
347 is configured to vibrate in response to the charge placed on
the electrodes. The number of bars and shape of the bars can be
configured to adjust the acoustic/vibrational properties of the
assembly.
[0118] Use of an electroactive polymer transducer as described
above further includes a circuit driver 350, the circuit driver 350
may be incorporated into the first or second circuit boards 500/550
as described above. Alternatively, the circuit driver 350 may be
embodied as a separate circuit board (not shown) which may be
electrically coupled with either the first or second circuit boards
of the present invention. The circuit driver 350 further includes
an audio input 360 and at least one output 370, but preferably a
pair of outputs 371 and 372. The outputs 371, 372 are coupled to
the electrodes 340, 345 of the transducer 315.
[0119] The circuit driver 350, may further include additional
components such as an amplifier, a filter, a voltage step-up
circuit, a charge controller, voltage step-down.
[0120] Further still it is contemplated that the driver assembly
may be embodied as multiple elements, for example any combination
of driver assemblies may be use, such as a combination of a haptic
speaker and a piezo, a haptic speaker and an electro active polymer
transducer, an electroactive polymer transducer and a piezo or
multiples of the same driver type within the same housing. The
examples provided herein should not be considered limiting in any
manner. Alternatively, the driver assembly may be a vibrating motor
or coin cell motor.
[0121] As described above and in accordance with the present
invention, it is contemplated that two therapy providing devices
200 may be utilized together to provide therapy to a user, wherein
the two therapy units may be interconnected with a physical
connection. It is contemplated that one of the therapy devices may
have a complete set of electronics disposed therein, wherein the
complete set of electronics would include the communication, memory
and other chipset(s) and associated circuitry. Wherein the other
therapy providing module 200 could then include a simplified
electronics module, wherein the simplified electronics module would
not have the complete chipset of the complete electronics module.
For example, the simplified electronics module would not need to
have a battery charging circuit or other chips as well it may have
less or no memory. By providing the other therapy providing device
with a slimmed down electronics module a larger energy source may
be fitted, through this arrangement the combined therapy providing
devices 200 could be utilized for a longer time before the energy
source would need to be replaced or recharged.
[0122] Referring now to FIG. 11 there is shown a charging/base
station 570 in accordance with the present invention. As shown in
FIG. 11, the base station 570 includes a housing 571, wherein the
housing 571 includes recessed portions 572 configured to receive
the therapy providing device 200 therein. The recessed portions 572
are configured to include charging pins 574, which when the therapy
providing device 200 is disposed within the recess will align with
the charging pins/pads 265 of the therapy providing device. In
addition to the charging pins 574, other pins may be included both
on the base 570 and the therapy providing device 200 which may be
used for other purposes such as downloading data stored within
memory of the therapy providing device(s) 200. The base station 570
may further include a wired or wireless connection to the internet
or other network such that the data received from the therapy
providing device(s) can be transmitted or uploaded to a webpage as
described above or transmitted to another location such as a health
care provider or other location for storage. It is further
contemplated that the base 570 may include additional features such
as an alarm clock or clock 573, a cellular telephone or tablet
charging station. As will be described in greater detail below with
regard to FIGS. 13L and 13M, the therapy providing device may
include extensions 219 extending from the housing 210 each
extension 219 containing a magnet 230. It is contemplated that the
recessed portions of the charging base 570 may be shaped to receive
the extensions 219 of the housing 210 shown in FIG. 13L. The
recessed portions 572 may be adapted to receive the extensions 219
or may further include a metallic member or a magnet disposed
therein, such that when the therapy providing device is placed into
the recessed portion, the magnets 230 within the housing 210 of the
therapy providing device 200 are attracted to the metal or magnet
of the charging station 570, thus, temporarily affixing the therapy
providing device 200 to the charging station. In addition to
temporarily affixing the therapy providing device 200 to the
charging station 570, by temporarily affixing the therapy providing
device 200 to the charging/base station 570 providing better
contact between the therapy providing device 200 and the charging
pins 574. It is contemplated that other arrangements to increase
contact between the therapy providing device and the charging pins
of the charging/base station may be utilized. For example, the
charging pins 574 in the base station 570 may be configured to move
linearly and be held with a spring force, whereby the charging pins
574 retract or partially retract when a therapy providing device
200 is placed into the recessed portion 572 for charging.
Additionally, another member (not shown), such as a plate or
weights may be placed onto the therapy providing devices after the
therapy providing devices have been disposed within the recessed
portions. Further still, the charging pins 574 may be disposed on a
lid (not shown) of the charging base 570, such that the therapy
providing device 200 is placed within a recessed portion 572 of the
charging base 570 and the lid is closed, thereby completing the
electrical connection between the charging pins 574 of the charging
base and the charging pins/pads 256 of the therapy providing device
200.
[0123] In accordance with the invention, the base 570 may be
further embodied as another medical device or incorporate other
medical devices. It is contemplated that the base 570 may
incorporate, or be incorporated into another medical device such as
a pulse-oximetry meter, a blood pressure monitoring device, a
glucose meter, an infusion pump, a glucose pump, sleep tracking
device, temperature measuring device, or a sleep apnea device such
as those offered by ResMed and Respironics. Presently, sleep apnea
devices utilize a console which houses the electronics necessary to
control a blower to deliver pressurized air to a patient interface.
The patient interface may be embodied in the form of a full-face
mask, nasal mask, oro-nasal mask, mouth mask, nasal prongs, or
other suitable configurations know in the art. Also, any suitable
headgear arrangements may be utilized to comfortably support the
patient interface in a desired position.
[0124] In yet another aspect of the present invention, referring
now to FIG. 12 there is shown the therapy providing device 200 of
the present invention, wherein the therapy providing device 200 has
been adapted to interface with a sleep apnea patient interface. As
show in FIG. 12, the therapy providing device 200 is configured to
be received or engage or is integrated into the headgear
arrangement of a sleep apnea patient interface device, wherein the
therapy providing device of the present invention is configured to
engage the patient's jawbone or skull.
[0125] In yet another aspect of the present invention, the therapy
providing device 200 may be incorporated into other devices which
are configured to engage a patient's tissue and skeletal bones such
as bone conduction hearing aids, one such example is being offered
by Sonitus Medical under the tradename SoundBite.
[0126] Referring now to FIGS. 13A, 14A, 14B, 15A, 15B, 16A and 16B
there are shown multiple embodiments of the housing 210 of the
therapy providing device 200 in accordance with the present
invention. As shown in these figures, the housing 210 is shown
having a variety of mounting assemblies that can be utilized to
affix the therapy providing device 200 to the patient.
[0127] As shown in FIG. 13A, one surface of the therapy providing
device is provided with a slot 260. A bandage 265 can be passed
through the slot 260, wherein a rib 261 formed by slot 260 retains
the therapy providing device 200 onto the bandage 265. The bandage
265 further includes a biocompatible adhesive, such that the
therapy providing device 200 can be affixed to the patient as shown
in FIG. 13B. The bandage may be a one-time use construction,
wherein the bandage is disposed of after a single use.
Alternatively, the bandage 265 may be a multiple-use product,
wherein the biocompatible adhesive is selected such that the
bandage can be placed and removed from a user's skin multiple
times. Additionally, it is contemplated that the biocompatible
adhesive may be renewed. The adhesive may be renewed by spreading
new adhesive over the existing adhesive, washing the adhesive
surface with a substance to renew the surface or the adhesive may
be embodied having multiple thin layers, wherein the user removes
the used layers and disposes of the used layer, thereby exposing a
new layer of adhesive for use again. A suitable example of an
adhesive for a reusable bandage are hydrogel adhesives, similar to
those utilized on electrodes for electrical muscle stimulation
devices, otherwise known as a TENS unit. Such electrodes are
manufactured and sold by 3M as well as others. It is contemplated,
that a temporary marking may be applied to the user's body
initially to indicate the location of where the therapy providing
device. For example, the temporary marking may be in the form of a
temporary tattoo or a henna tattoo.
[0128] Alternatively, a bandage large enough to cover the entire
housing of the therapy providing device 200 may be utilized. In
this embodiment, the bandage would hang over the edge of the
housing by a sufficient amount, such that when the therapy
providing device 200 is placed against the tissue of the user, the
bandage could be affixed to the tissue to hold the therapy
providing device in a desired position. In this embodiment, the
bandage may include an aperture, an opaque section or otherwise
transparent section, such that when the bandage is placed over the
therapy providing device 200, the button 260, LEDs 262 and charging
pins/ports 265 on the top surface of the housing 210 of the therapy
providing device 200 described above are visible and accessible if
the housing includes such components. Such as bandage may be
constructed to further include a one-way membrane, wherein moisture
under the bandage may be transported or migrate from the tissue
surface through the bandage, however, the bandage would not allow
fluid to pass from the outside to the therapy providing device 200
or the user's tissue.
[0129] Referring now to FIGS. 14A-14C there is shown an alternative
design for affixing the therapy providing device 200 to the
patient. In this embodiment, one surface of the therapy providing
device includes a first fitting 280 disposed on the second surface
215 of the housing 210. A bandage 400 is provided, wherein the
bandage 400 has a proximal surface 402 and a distal surface 401. A
biocompatible adhesive is disposed on the distal surface of the
bandage 401. A second fitting 281 is disposed on the proximal
surface 402 of the bandage 400. The first fitting 280 and the
second fitting 281 are designed to be received by each other and to
form a detachable locking attachment as shown in FIG. 14C. Suitable
examples of such detachable fittings may be a screw thread, quarter
turn fasteners, grooved pathways, a tapered fitting and the like. A
safety lock (not shown) may be incorporated into either of the
fittings, wherein the safety lock would engage after the two
fittings are brought together in a locking arrangement. The safety
lock would prevent the fittings from releasing without an
additional application of force or motion to the safety lock to
enable the fittings to be separated. The bandage 400 may be a
single use product or may be a re-usable bandage as described
above. In another aspect, the bandage of the present invention may
be fabricated to include multiple layers, wherein each layer
includes a new glue surface. After use, the layer of the bandage
having been in contact with tissue is peeled off by the user and
properly disposed of, thereby exposing a new glue layer for further
use.
[0130] Referring now to FIGS. 15A and 15B there is shown another
alternative design for affixing the therapy device 200 to a
patient. In this embodiment, a surface of the therapy device 200
includes a magnet 290 disposed thereon or incorporated into the
surface. As described above bandage 400 is provided, wherein the
bandage 400 has a proximal surface 402 and a distal surface 401. A
biocompatible adhesive is disposed on the distal surface of the
bandage 401. A metallic member 292 is incorporated into the bandage
400 as shown in FIG. 15B. In use, the user would apply the bandage
400 to their body, wherein the center of the bandage would align
with their clavicle. In one embodiment, the bandage 400 would be
replaced daily. In another embodiment, the bandage 400 would be
reused for a period of time and then replaced. Further still, in
another embodiment, the glue surface of the bandage 400 may be
refurbished after each use to prolong the useful life of the
bandage 400. Once the bandage 400 is affixed to the user, the
therapy providing device 200 as shown in FIG. 15A and described
above would then be coupled to the bandage through the magnetic
coupling between the magnet 290 of the therapy providing device 200
and the metallic member 292 of the bandage 400. It shall be
understood that the combination of using a magnet 290 and a
metallic member 292 could be reversed. For example, the bandage 400
may contain the magnet 290 and the therapy providing device 200
would have the metallic member 292. Alternatively, both the bandage
400 and the therapy providing device 200 may include a magnet 290,
whereby the magnets 290 assist in self-aligning the therapy
providing device to the bandage 400. Further still, it is
contemplated that the magnet or metallic member of either the
bandage 400 or the therapy providing device 200 may be offset from
an axis extending through the center of the bandage 400, thereby
providing for two different orientations in which the therapy
providing device 200 may disposed upon the bandage 400 in for use.
Further still, it is contemplated that the driver 220 of the
therapy providing device may be offset within the housing 210 from
an axis running longitudinally through the housing 210. Offsetting
the driver 220 within the housing 210, achieves the same effect of
providing multiple mounting orientations of the therapy providing
device 200 during use. In yet another embodiment, the magnet 290 or
metallic member 292 could be implanted under the user's skin,
therefore eliminating the need for the bandage 400. In this
embodiment, the therapy providing device 200 could be coupled to
the patient's skin directly.
[0131] In another embodiment (not shown) the bandage may include an
aperture formed therethrough, wherein the metallic member 292 would
be disposed about the aperture. The aperture is sized to receive a
portion of the therapy providing device 200 therein. It is further
contemplated that the therapy providing device may include a second
bandage or an enlarged surface similar in size to the bandage 400.
The enlarged surface would contain magnets 290 as described above;
therefore, when the therapy providing device 200 is disposed within
the aperture of the bandage 400, the enlarged surface covers the
bandage.
[0132] In further embodiments, the magnets and the metallic members
may be interchanged, wherein the bandage contains the magnets and
the housing may be a metallic member, a portion may be metallic or
a portion may be magnetic. Additionally, instead of utilizing
magnets and metallic members, other known detachable systems may be
utilized, for example a hook and loop configuration or reusable
adhesive surface.
[0133] Referring now to FIGS. 16A and 16B there is shown a housing
in accordance with the present invention, wherein the housing 210
includes extensions 219. The extensions 219 further include magnets
230 disposed therein. Referring now to FIG. 16B there is shown a
bandage 420 to be utilized with the housing shown in FIG. 16A. The
bandage 420 further includes an aperture 431 formed therethrough,
the aperture sized to accept a portion of the therapy providing
device 200. The bandage 420 further includes magnets 430 disposed
therein. The bandage 420 may be formed of a multilayer
construction, wherein the bandage may include a glue layer a glue
support layer and a backing layer. It is contemplated that the
magnets 430 could be disposed within the glue support layer,
wherein the magnets 430 would be encapsulated in the bandage 420 by
the glue layer and the backing layer. In use, the user would place
the bandage 420 onto their skin, wherein the user can use the
aperture 431 to properly align the bandage in the example where the
therapy providing device is placed over the clavicle. The glue
layer of the bandage 420 may be a re-usable adhesive, such as that
described above and commonly utilized on tens electrodes, wherein
the glue layer allows for repositioning of the bandage. After
placement of the bandage 420, the therapy providing device, having
a housing shown in FIG. 16A is disposed over the bandage. The
magnets 230 of the housing extensions 219 and the magnets 430 of
the bandage act to attach and center the therapy providing device
to the bandage. In accordance with the invention, it is
contemplated that either the magnets 230 of the housing or the
magnets 430 of the bandage may be replaced by metallic members.
[0134] In yet another aspect of the invention, as described herein
the magnets, which may be positioned in the device housing, the
bandage or both, may be utilized to control the function of the
therapy providing device 200. In this example, at least one of the
magnets can be used as a switch to control or complete a power
circuit. The power circuit can be activated such as to power the
therapy providing device 200 on, thereby initiating therapy. If the
magnetic connection is broken, then the therapy providing device
would be powered off. It is further contemplated, that in addition
to the above, the magnet within the device or bandage may be
manufactured with specific properties, such that the therapy
providing device will only operate with original equipment
manufacturing products, thereby preventing the therapy providing
device 200 from being utilized with non-approved or counterfeit
bandages. A benefit of utilizing the magnets to switch the device
on/off is that the user does not have to activate any buttons on
the device, additionally, the device can be simplified through the
eliminate of the button on the therapy providing device as
described herein. Another benefit is the preservation of battery
life of the device, as the device will be powered off as soon as
the magnetic connection is broken. Additionally, if the therapy
providing device is being utilized at night time during sleep and
the device becomes dislodged from the user, the device will
automatically power off, thus providing an additional safety
feature.
[0135] Further still, it is contemplated, that the therapy
providing device 200 and/or bandage may include a security feature,
such as an optical scanner disposed within the therapy providing
device, such that the optical scanner is configured to scan a QR
code, bar code or other coded printed on the bandage or bandage
packaging. As described above, this combination of a scanner and
specific code can be utilized to control the activation of the
therapy providing device 200. Additionally, the use of a security
code/barcode can be combined with the magnetic activation of the
therapy providing device 200 as described above to ensure that the
bandage being utilized is an approved product that has been
designed to be specifically utilized with the therapy providing
device 200 and that the bandage is not a third-party un-approved
product or a counterfeit product. It is contemplated that other
types of security systems can be utilized to achieve the same or
similar functions. For example, the bandage may include a
protrusion (not shown) that projects above the surface of the
bandage, the protrusion would be received within an aperture of the
second surface of the housing where it would activate a switch
within the housing. Another example would be the use of an
electronic circuit or chip disposed upon or within the bandage, the
circuit or chip would interface with the therapy providing device,
thereby completing a circuit to enable activation of the therapy
providing device.
[0136] Referring now to FIG. 17 there is shown an alternative
design for a mounting device to be utilized with the therapy system
100 in accordance with the present invention. As shown in FIG. 17
there is shown a support structure 600. The support structure 600
can be configured to position therapy providing devices 200
according to the present invention in a preferred location over a
user's clavicle. The user can also adjust the positioning of the
location of the therapy providing devices 200 by adjusting both the
angle of the arm about pivot 610 and buy adjusting the length
through the telescoping assembly 620.
[0137] The support structure 600 further includes a ball and cup
joint 660 at the distal ends 640 of the arms 630. The ball and cup
joint 660 is arranged to hold the therapy providing device 200 and
allows a user to align the therapy providing device 200
substantially parallel to a surface of the user at the desired
location to insure that as much as possible of the therapy
providing device 200 is in contact with the user.
[0138] The support structure 600 further includes a pad 650
connected to the arms 630. In accordance with embodiments of the
present invention, the pad may contain the electronics module 320
and the power source.
[0139] The arms 630 of the support structure 600 can also be
configured to include a spring force to push the therapy providing
device 200 against the body. For example, the arms 630 of the
support structure 600 depicted in FIG. 17 are curved and are
configured to apply a spring force between the therapy providing
units 200 and the pad 650 when the support structure 600 is placed
over a user's shoulders.
[0140] Referring now to FIG. 18 there is shown another example, of
a support structure 700 in accordance with the present invention.
As shown in FIG. 4H, the support structure 700 includes a pad 750,
a first arm 730, and second arms 731. The support structure 700
further includes joints 740, the joints 740 join the first arm 730
to the second arms 731. The joints 740 are configured to allow for
rotational motion between the first arm 730 and the second arms 731
in order to allow a user to align the therapy providing devices 200
in accordance with the methods of the present invention. The second
arms 731 further include telescoping sections 745. The telescoping
sections 745 allow the user to adjust the length of the second arms
731 to position the therapy providing units properly. The second
arms 731 further include a ball joint assembly 760 disposed at
their distal ends, the ball joint assemblies 760 couple the therapy
providing units to the second arms 731. The ball joint assemblies
760 allow the therapy providing units to lay flat against the
user's collar bones and account for differences in anatomy. The
support structure 700 further includes a pad 750 coupled to the
first arm 730. As described above the pad 750 may contain the
electronics module 320 and the power source. In certain embodiments
the electronics module and power source would be user replaceable.
In other embodiments, the electronics module and battery would not
be user replaceable and the entire assembly would be replaced
including the therapy providing devices.
[0141] The support structures 600 and 700 can be made of an elastic
material. The elasticity of the design provides for a spring or
clamping force, such that the support structure and therapy
providing devices remain in position during use.
[0142] The support structures described herein can be configured to
fit snugly without being too compressive on the body, are
straightforward to put on over the shoulders or around the torso,
and can be worn underneath clothing without significantly altering
the profile of the clothing.
[0143] Referring now to FIGS. 19A-19C, there are shown additional
embodiments of the present invention. As shown in FIGS. 19A-19C,
the therapy providing device 200 of the present invention may be
incorporated into a support structure 800, wherein the support
structure 800 includes a proximal end 802 and a distal end 801 and
an elongate member 803 extending between the two ends. The support
structure further includes a control panel 810, wherein the control
panel 810 may include an indicator such as a light or LED 811 to
indicate the function of the therapy providing devices 200. The
control panel 810 further includes a switch 813, the switch 813
being in electrical communication with the therapy providing
devices 200 and the electronics module 230 and the energy source
240, each of which have been described above. The support structure
800 may be fabricated of fabric such as cotton, nylon, polyester or
the like, wherein the body 803 is in the form of a tubular, square,
rectangular or cylindrical shape, thereby forming an inner chamber.
As shown in FIG. 4I, the therapy providing devices 200 and the
electronics module 230 and energy source 240 are shown disposed
within the inner chamber. These components may be held within the
inner chamber through the use of pockets formed within the inner
chamber. It is further contemplated that the inner chamber may be
filled with a material to increase the weight of the overall
device. Examples of materials that can be utilized to fill the
chamber are rice, beans, sand, metallic materials, polymer
materials and other such materials that are known to one skilled in
the art.
[0144] As shown in FIGS. 19B and 19C, the support structure 800 can
be worn around a user's neck and shoulders, wherein the therapy
providing device 200 would be adjusted by the user to fall onto and
make contact with the user's clavicle. The support structure 800
may be disposed over the top of a user's clothing as shown in FIG.
19B, or alternatively the support structure 800 may be disposed
directly against a user's skin as shown in FIG. 19C.
[0145] In accordance with the embodiment shown in FIGS. 19A-19C, it
is contemplated that the support structure may further include a
removable cover (not shown), wherein the removable cover can be
disposed about the support structure 800. The removable cover may
include a zipper, velcro or snaps to open and close the cover.
Additionally, the removable cover may include additional items such
as pads placed along a portion or a length thereof. For example, a
pad may be disposed on the cover near the user's neck area.
[0146] It is further contemplated that the support structure 800 in
accordance with the present invention may include additional
features. For example, a heating element may be incorporated into
the support structure 800, whereby the heating element may be
utilized by the user to address sore muscles or neck pain.
[0147] Referring now to FIGS. 20A and 20B, there are shown
exemplary embodiments of clothing articles which can be utilized
with the therapy providing device 200 of the present invention.
[0148] As shown in FIG. 20A, in one embodiment, the clothing
article is embodied as a t-shirt 600, wherein the t-shirt 600
includes pockets 602 formed therein to receive the therapy
providing device 200. The pockets 602 are aligned over the user's
clavicle in order to provide treatment as will be described
below.
[0149] Referring now to FIG. 20B there is shown an alternative
embodiment of a piece of clothing configured to retain the therapy
device 200 in accordance with the present invention. As shown in
FIG. 5B the clothing can be embodied in the form of a sports bra
610. The sports bra 610 further includes pockets 612 configured to
receive the therapy device 200. Alternatively, instead of pockets,
other attachment mechanisms such as those described above, wherein
instead of pockets, magnets, hook and loop fasteners, snap
fasteners, twist and lock or similar types of fastening systems may
be utilized to retain the therapy providing device 200 in
position.
[0150] Additionally, the clothing devices described above may
further include an additional pocket or pockets to receive the
computing device, or in embodiments wherein the electronics or
energy source are separate from the therapy providing device,
pockets or other retention means to retain these additional
components.
[0151] The clothing devices may further include a structure formed
therein or attached thereto (not shown) wherein the structure is
configured to apply a downward force upon the therapy providing
device(s). Structures similar to those shown in FIGS. 17, 18 and 19
may be utilized.
[0152] In accordance with the present invention, the therapy
providing device 200 may include addition features. One such
additional feature can be the inclusion of a thermometer to track
the user's temperature during use. Another additional feature can
be the inclusion of a sleep sensor or sleep tracking program,
wherein the therapy providing device can be utilized to track the
user's sleep. For example, the sleep program may utilize the
GPS/accelerometer of the therapy providing device to track movement
during sleep, wherein the sleep program could further utilize the
temperature data as well. Another aspect of the invention could be
to utilize the therapy providing device to be further utilized to
diagnose sleep apnea, wherein the therapy providing device could
further include a microphone to enable audio recording of the
user's breathing during sleep. Additionally, the microphone
recording of the breathing can be combined with the accelerometer
data or GPS/tilt data to correlate the breathing recordings to the
specific user.
[0153] Referring now to FIGS. 21A and 21B there is shown a
computing device 800 in accordance with the present invention. The
computing device 800 includes a processor, memory, energy source
(such as a battery), and a display 810. The computing device may be
a custom manufactured device for use with the therapy device 200 as
described above, or alternatively, the computing device 800 may be
a commercially available device such as a smartphone or tablet.
Examples of such commercially available devices are iOS enabled
devices such as the iPhone.RTM., iPad.RTM., iPod.RTM., Android
based phones and/or tablets, laptops or computers. As shown in FIG.
15B, the computing device may be configured to display a user's
heart rate and blood pressure when connected to a therapy providing
device having those measurement capabilities or where other
compatible devices are utilized with the therapy providing device.
Alternatively, the computing device may display data received from
one or more therapy providing devices, this data may include
start/stop times of therapy provided by the therapy providing
device 200, battery status of one or more therapy providing devices
and the like.
[0154] In accordance with the present invention, the computing
device 300 is configured to run a program 320. In accordance with
the present invention, the program 320 is configured to communicate
with the therapy device 200. The communication between the program
320, computing device 300 and the therapy device 200 may be
conducted using Bluetooth, wifi, ZigBee, NFC, RFID, ANT+, 3G/4G,
cellular connection or other known wireless communication
protocols. Alternatively, the computing device may be coupled to at
least one of the therapy devices through a cable connection.
[0155] In an alternative embodiment, the program 820 is stored on
memory located within the memory of the therapy providing device
200. The program maybe initiated manually through the use of a
physical button pressed by the user. Alternatively, the program 820
may be initiated automatically by a timer located within the
therapy providing device 200. The timer may further utilize data
inputs from an accelerometer/compass or tilt sensor to indicate
when the user is in a prone position to initiate the program 820.
Further still, the timer may receive input from an impedance sensor
indicating whether the therapy providing device 200 is in proper
placement on the users body. The program would then be initiated
based on the inputs received. The device may be activated further
by the light sensor either from the darkness against the skin. The
device may be activated from the reduced light from the users
surroundings, for example when the user is sleeping.
[0156] In certain embodiments, the program 820 is pre-configured to
deliver therapy using the therapy providing device through
pre-programmed parameters. The HCP may adjust the therapy
parameters within the program 820, such that the therapy provided
to the user may be customized to the user. The customization of the
therapy may be changes to the wavelength, amplitude, duration,
start/stop times. The customization may be done by the HCP while
providing services to the patient, for example, the HCP may apply
the therapy providing device to the patient, initiate therapy and
monitor the patient's response. Through this active monitoring, the
HCP may change the parameters of the program to elicit a response
in the patient. For example, it is contemplated that certain
patients may have different bone densities; therefore the therapy
provided by the device may need to be adjusted accordingly. It is
further contemplated, that once programmed, the user cannot change
the therapy parameters of the program, or alternatively, certain
parameters or all parameters may be open to change by the end user
or remotely. Alternatively, the HCP, after determining the best
therapy parameters, can choose from multiple programs stored within
memory of the therapy providing device. Further still, the HCP may
be provided with a dedicated programming device, or may couple the
device to a personal computer, smartphone, tablet or other internet
enabled device, such that the HCP can utilize the dedicated
programmer or download over a secure internet connection, programs
to be uploaded into the therapy providing device.
[0157] Referring now to FIG. 22, there is shown a flow diagram
illustrating the program 820 in accordance with one embodiment of
the present invention. As shown in FIG. 22, the program 820 may
configured to be run on the computing device 800 to control the
therapy applied to the user by the therapy providing device 200.
Alternatively, it is contemplated that the program 820 may reside
within memory within the therapy providing device 200 as described
above.
[0158] At Box 830, the user activates the program on the computing
device 800 or therapy providing device 200.
[0159] At Box 840, the program checks the time on the computing
device 800 or internally from the clock circuit of the therapy
providing device 200.
[0160] At Box 850, the program determines whether to turn the
therapy providing device on based upon the time check in Box 840.
If the time is before a pre-programmed time or a user set time,
then the program returns to Box 840. If the time is after the
pre-set time or user set time, then the program turns the therapy
providing device on. In accordance with the invention, if the time
is received from the computing device, a user may adjust the time
of the computing device, for example if the computing device is
moved from one time zone to another. Alternatively, the computing
device may automatically update the time.
[0161] At Box 860, the therapy providing device 200 is provided
with a signal generated by the program and transmitted from the
computing device 800 through a selected transmission method. In
alternative embodiments, the therapy providing device contains a
processor and memory, wherein a program is retained within the
memory of the therapy providing device. In this embodiment, the
signal provided by the computing device 800, is a power on/off
signal, wherein once powered on the program residing within the
memory of the therapy providing device will begin to run.
[0162] At Box 870, the therapy device provides therapy to the
patient. In the process of providing therapy, a signal is
transmitted to the therapy device 200 by the computing device 800
through as directed by the program 820, or as described above, the
program residing in the memory of the therapy providing device
runs. In one embodiment, the therapy is applied for a set period of
time. In alternative embodiments, the time duration of the therapy
may be determined based upon data received from other sensors
disposed upon the user or about the user. In yet another
embodiment, the user may manually deactivate the therapy providing
device/program.
[0163] At Box 880, the therapy is stopped. The therapy may be
stopped based upon a time event, motion event, manually by the
user, automatically by the program.
[0164] During each of the steps described above and shown in the
flow diagram of FIG. 22, the user may be presented with displays on
the screen 810 of the computing device. The screen 810 may display
the start and stop times of the therapy, these times may be set by
the user or may be set for the user by a health care provider.
Alternatively, the times maybe automatically generated in response
to data received from other sensors as will be described in detail
below.
[0165] According to the invention, the program includes a
non-transitory computer readable medium having computer executable
program code embodied thereon, the computer executable program code
configured to send appropriate signals to the circuit board(s)
500/550 to provide therapy in accordance with the methods of the
present invention utilizing the therapy providing device 200 of the
present invention.
Methods of Use
[0166] In accordance with the present invention, methods of use of
the present invention will be described below. The methods
described shall be considered to be exemplary and should not be
considered limiting in any manner.
[0167] In accordance with one embodiment of the present invention,
the therapy device includes a driver assembly, wherein the driver
assembly is embodied as a speaker as shown in FIGS. 5 and 73. The
speaker may be a haptic speaker, a piezoelectric speaker, an
electroactive polymeric transducer, or a magnetic coil speaker. The
computing device 800 and program 810 are configured to provide a
signal to the speaker to cause the speaker to vibrate at certain
frequencies or to oscillate or translate through a range of
frequencies.
[0168] In accordance with embodiments of the present invention, the
frequencies contemplated for use with the present invention range
between 0 Hz to 20,000 Hz, 0 Hz and 10,000 Hz, 0 Hz and 5,000 Hz, 0
Hz and 2,500 Hz, 0 Hz and 1,750 Hz, 0 Hz and 875 Hz, 0 Hz and 435
Hz, 0 Hz and 200 Hz, 0 Hz and 150 Hz, 1 Hz and 150 Hz, 2 Hz and 150
Hz, 3 Hz and 150 Hz, 4 Hz and 150 Hz, 5 Hz and 150 Hz, 6 Hz and 150
Hz, 7 Hz and 150 Hz, 8 Hz and 150 Hz, 9 Hz and 150 Hz, 10 Hz and
150 Hz, 11 Hz and 150 Hz, 12 Hz and 150 Hz, 13 Hz and 150 Hz, 14 Hz
and 150 Hz, 15 Hz and 150 Hz, 16 Hz and 150 Hz, 17 Hz and 150 Hz,
18 Hz and 150 Hz, 19 Hz and 150 Hz, 20 Hz and 150 Hz, 21 Hz and 150
Hz, 22 Hz and 150 Hz, 23 Hz and 150 Hz, 24 Hz and 150 Hz, 25 Hz and
150 Hz, 26 Hz and 150 Hz, 27 Hz and 150 Hz, 28 Hz and 150 Hz, 28 Hz
and 150 Hz, 29 Hz and 150 Hz, 30 Hz and 150 Hz, 31 Hz and 150 Hz,
32 Hz and 150 Hz, 33 Hz and 150 Hz, 34 Hz and 150 Hz, 35 Hz and 150
Hz, 36 Hz and 150 Hz, 37 Hz and 150 Hz, 38 Hz and 150 Hz, 39 Hz and
150 Hz, 40 Hz and 150 Hz, 41 Hz and 150 Hz, 42 Hz and 150 Hz, 43 Hz
and 150 Hz, 44 Hz and 150 Hz, 45 Hz and 150 Hz, 46 Hz and 150 Hz,
47 Hz and 150 Hz, 48 Hz and 150 Hz, 49 Hz and 150 Hz, 50 Hz and 150
Hz, 51 Hz and 150 Hz, 52 Hz and 150 Hz, 53 Hz and 150 Hz, 54 Hz and
150 Hz, 55 Hz and 150 Hz, 56 Hz and 150 Hz, 57 Hz and 150 Hz, 58 Hz
and 150 Hz, 59 Hz and 150 Hz, 60 Hz and 150 Hz, 61 Hz and 150 Hz,
62 Hz and 150 Hz, 63 Hz and 150 Hz, 64 Hz and 150 Hz, 65 Hz and 150
Hz, 66 Hz and 150 Hz, 67 Hz and 150 Hz, 68 Hz and 150 Hz, 69 Hz and
150 Hz, 70 Hz and 150 Hz, 71 Hz and 150 Hz, 72 Hz and 150 Hz, 73 Hz
and 150 Hz, 74 Hz and 150 Hz, 75 Hz and 150 Hz, 76 Hz and 150 Hz,
77 Hz and 150 Hz, 78 Hz and 150 Hz, 79 Hz and 150 Hz, 80 Hz and 150
Hz, 81 Hz and 150 Hz, 82 Hz and 150 Hz, 83 Hz and 150 Hz, 84 Hz and
150 Hz, 85 Hz and 150 Hz, 86 Hz and 150 Hz, 87 Hz and 150 Hz, 88 Hz
and 150 Hz, 89 Hz and 150 Hz, 90 Hz and 150 Hz, 91 Hz and 150 Hz,
92 Hz and 150 Hz, 93 Hz and 150 Hz, 94 Hz and 150 Hz, 95 Hz and 150
Hz, 96 Hz and 150 Hz, 97 Hz and 150 Hz, 98 Hz and 150 Hz, 99 Hz and
150 Hz, 100 Hz and 150 Hz, 101 Hz and 150 Hz, 102 Hz and 150 Hz,
103 Hz and 150 Hz, 104 Hz and 150 Hz, 105 Hz and 150 Hz, 106 Hz and
150 Hz, 107 Hz and 150 Hz, 108 Hz and 150 Hz, 109 Hz and 150 Hz,
110 Hz and 150 Hz, 111 Hz and 150 Hz, 112 Hz and 150 Hz, 113 Hz and
150 Hz, 114 Hz and 150 Hz, 115 Hz and 150 Hz, 116 Hz and 150 Hz,
117 Hz and 150 Hz, 118 Hz and 150 Hz, 119 Hz and 150 Hz, 120 Hz and
150 Hz, 121 Hz and 150 Hz, 122 Hz and 150 Hz, 123 Hz and 150 Hz,
124 Hz and 150 Hz, 125 Hz and 150 Hz, 126 Hz and 150 Hz, 127 Hz and
150 Hz, 128 Hz and 150 Hz, 129 Hz and 150 Hz, 130 Hz and 150 Hz,
131 Hz and 150 Hz, 132 Hz and 150 Hz, 133 Hz and 150 Hz, 134 Hz and
150 Hz, 135 Hz and 150 Hz, 136 Hz and 150 Hz, 137 Hz and 150 Hz,
138 Hz and 150 Hz, 139 Hz and 150 Hz, 140 Hz and 150 Hz, 141 Hz and
150 Hz, 142 Hz and 150 Hz, 143 Hz and 150 Hz, 144 Hz and 150 Hz,
145 Hz and 150 Hz, 146 Hz and 150 Hz, 147 Hz and 150 Hz, 148 Hz and
150 Hz, 149 Hz and 150 Hz, 150 Hz and 150 Hz, 60 Hz and 100 Hz, 61
Hz and 100 Hz, 62 Hz and 100 Hz, 63 Hz and 100 Hz, 64 Hz and 100
Hz, 65 Hz and 100 Hz, 66 Hz and 100 Hz, 67 Hz and 100 Hz, 68 Hz and
100 Hz 69 Hz and 100 Hz, 70 Hz and 100 Hz, 60 Hz and 99 Hz, 61 Hz
and 99 Hz, 62 Hz and 99 Hz, 63 Hz and 99 Hz, 64 Hz and 99 Hz, 65 Hz
and 99 Hz, 66 Hz and 99 Hz 67 Hz and 99 Hz, 68 Hz and 99 Hz, 69 Hz
and 99 Hz and 70 Hz and 99 Hz, and 61 Hz and 98 Hz, 62 Hz and 98
Hz, 63 Hz and 98 Hz, 64 Hz and 98 Hz, 65 Hz and 98 Hz, 66 Hz and 98
Hz, 67 Hz and 98 Hz, 68 Hz and 98 Hz, 69 Hz and 98 Hz and 70 Hz and
98 Hz.
[0169] In a preferred embodiment the signal causes the driver
assembly to vibrate at a frequency or sweep through a range of
frequencies between about 40 Hz and 150 Hz, more preferably between
50 Hz and 125 Hz, most preferably between about 60 Hz and 115 Hz.
In accordance with the present invention, a therapeutic response
has been achieved utilizing a frequency range between 65 Hz and 100
Hz.
[0170] It is further contemplated that these frequencies may be
doubled and still achieve the therapeutic lowering of blood
pressure in accordance with the present invention. It is further
contemplated that these frequencies may be halved and still achieve
the therapeutic lowering of blood pressure in accordance with the
present invention.
[0171] In additional embodiment of the present invention, the
driver assembly may vibrate or sweep or step between frequencies of
between 60 Hz, 61 Hz, 62 Hz, 63 Hz, 64 Hz, 65 Hz, 66 Hz, 67 Hz, 68
Hz, 69 Hz, 70 Hz, 71 Hz, 72 Hz, 73 Hz, 74 Hz, 75 Hz, 76 Hz, 77 Hz,
78 Hz, 79 Hz, 80 Hz, 81 Hz, 82 Hz, 83 Hz, 84 Hz, 85 Hz, 86 Hz, 87
Hz, 88 Hz, 89 Hz, 90 Hz, 91 Hz, 92 Hz, 93 Hz, 94 Hz, 95 Hz, 96 Hz,
97 Hz, 98 Hz, 99 Hz and 100 Hz.
[0172] Referring now to FIGS. 23A and 23B, there is shown a further
embodiment wherein the therapy is provided utilizing a combination
of single frequencies and a sweeping frequency. For example, the
driver assembly would be driven to vibrate at a single frequency,
F1, for a period of time, then driven to sweep through a range of
frequencies, F2, then driven at a single frequency, F3, different
than the first single frequency, F1, and then finally driven
backwards through the sweep of frequencies above, F4. This cycle
may be repeated for a set period of time, turned off for a period
of time and then repeated again, until an overall time period of
therapy is reached.
[0173] It is further contemplated that multiple signals utilizing
separate frequencies may be transmitted by the program to the
speaker. For example, one signal may be transmitted at one
frequency and a second signal at another frequency. The signals may
be transmitted simultaneously, independently or in an alternating
fashion. If at least two therapy providing devices 200 are
utilized, then one therapy providing device 200 may receive a first
signal and the other receives a second signal.
[0174] In one embodiment, at least two therapy providing devices
200 are utilized. In use a signal will be sent to one of the two
therapy providing devices 200, causing the speaker to emit a signal
having a chosen frequency or range of frequencies. The signal is
transmitted to a first therapy providing device 200 for a
pre-determined period of time. After such time, the signal is
terminated. Upon termination of the first signal, a second signal
is generated and transmitted to the other therapy providing device.
This second signal causes the speaker to emit a signal having a
chosen frequency or range or frequencies. The chosen frequency may
be the same as that transmitted to the first therapy providing
device or it may be at a different frequency. The second signal
will be transmitted to the second therapy providing device for a
pre-determined period of time. After such time, the signal is
terminated. The program will continued to run, however, during this
time no signal will be transmitted to either therapy providing
device 200, thereby creating a pause between activation of the
therapy providing devices 200. After the pre-determined time period
of the pause has passed, the program will then enter a loop and
repeat the process described above. This pattern of therapy will
repeat for as long as the program has been instructed to do so.
[0175] In the embodiment where two therapy providing devices 200
are utilized, each of the devices deliver a waveform to the user's
left and right clavicle. The waveform is transmitted from the
speaker in each of the therapy providing devices to the user's
clavicles. The waveform is transmitted through the clavicle on the
left and right side, where both waves meet at the sternum to create
a standing wave.
[0176] Further still, in accordance with the present invention, the
amplitude of the signal can be adjusted to adjust the sound
pressure generated by the driver assembly 220 of the therapy
providing device 200. It is contemplated that the amplitude may be
doubled or increased even more to deliver the therapy in accordance
with the present invention. In accordance with the invention, the
therapy providing device 200 may be configured to provide a sound
pressure between: 0 to 150 decibels, 0 to 100 decibels, 0 to 99
decibels, 0 to 98 decibels, 0 to 97 decibels, 0 to 96 decibels, 0
to 95 decibels, 0 to 94 decibels, 0 to 93 decibels, 0 to 92
decibels, 0 to 91 decibels, 0 to 90 decibels, 0 to 89 decibels, 0
to 88 decibels, 0 to 87 decibels, 0 to 86 decibels, 0 to 85
decibels, 0 to 84 decibels, 0 to 83 decibels, 0 to 82 decibels, 0
to 81 decibels, 0 to 80 decibels, 0 to 79 decibels, 0 to 78
decibels, 0 to 77 decibels, 0 to 76 decibels, 0 to 75 decibels, 0
to 74 decibels, 0 to 73 decibels, 0 to 72 decibels, 0 to 71
decibels, 0 to 70 decibels, 0 to 69 decibels, 0 to 68 decibels, 0
to 67 decibels, 0 to 66 decibels, 0 to 65 decibels, 0 to 64
decibels, 0 to 63 decibels, 0 to 62 decibels, 0 to 61 decibels, 0
to 60 decibels, 0 to 59 decibels, 0 to 58 decibels, 0 to 57
decibels, 0 to 56 decibels, 0 to 55 decibels, 0 to 54 decibels, 0
to 53 decibels, 0 to 52 decibels, 0 to 51 decibels, 0 to 50
decibels, 0 to 49 decibels, 0 to 48 decibels, 0 to 47 decibels, 0
to 46 decibels, 0 to 45 decibels, 0 to 44 decibels, 0 to 43
decibels, 0 to 42 decibels, 0 to 41 decibels, 0 to 40 decibels, 0
to 39 decibels, 0 to 38 decibels, 0 to 37 decibels, 0 to 36
decibels, 0 to 35 decibels, 0 to 34 decibels, 0 to 33 decibels, 0
to 32 decibels, 0 to 31 decibels, 0 to 30 decibels, 0 to 29
decibels, 0 to 28 decibels, 0 to 27 decibels, 0 to 26 decibels, 0
to 25 decibels, 0 to 24 decibels, 0 to 23 decibels, 0 to 22
decibels, 0 to 21 decibels, 0 to 20 decibels, 0 to 19 decibels, 0
to 18 decibels, 0 to 17 decibels, 0 to 16 decibels, 0 to 15
decibels, 0 to 14 decibels, 0 to 13 decibels, 0 to 12 decibels, 0
to 11 decibels, 0 to 10 decibels, 0 to 9 decibels, 0 to 8 decibels,
0 to 7 decibels, 0 to 6 decibels, 0 to 5 decibels, 0 to 4 decibels,
0 to 3 decibels, 0 to 2 decibels, 0 to 1 decibels, 0 to 0.5
decibels, 0 to 0.25 decibels, 10 to 100 decibels, 20 to 100
decibels, 30 to 100 decibels, 40 to 100 decibels, 50 to 100
decibels, 60 to 100 decibels, 70 to 100 decibels, 80 to 100
decibels, 90 to 100 decibels, 10 to 75 decibels, 20 to 75 decibels,
30 to 75 decibels, 40 to 75 decibels, 50 to 75 decibels, 60 to 75
decibels, 70 to 75 decibels, 10 to 65 decibels, 20 to 65 decibels,
30 to 65 decibels, 40 to 65 decibels, 50 to 65 decibels and 60 to
65 decibels, 20 to 30 decibels, 30 to 40 decibels, 40 to 50
decibels, 50 to 60 decibels, 60 to 70 decibels, 70 to 75 decibels,
80 to 90 decibels, 50 to 75 decibels and 50 to 65 decibels.
[0177] Further still, in accordance with the present invention, the
standing wave may be of half-octave, double octave, or reflective
incidence. Thus the frequencies delivered at the collarbone may
independently collide across the breastbone or sternum and create a
new frequency which is of a different or same frequency as the
generating waves.
[0178] In accordance with the present invention, the frequency
selected for therapy may be held constant while the sound pressure
level can be increased or decreased, alternatively, the sound
pressure level may be held constant and the frequency varied. The
measurement of a sound pressure level is related to the
displacement of a portion of the delivery device 220. The portion
of the delivery device 220 may be displaced between: 0 mm and 20
mm, 0 mm to 10 mm, 0 mm to 9 mm, 0 mm and 8 mm, 0 mm to 7 mm, 0 mm
to 6 mm, 0 mm to 5 mm, 0 mm and 4 mm, 0 mm and 3 mm, 0 mm and 2 mm,
0 mm and 1 mm, 0 mm and 0.5 mm, 0 mm to 0.05 mm, 0 mm to 0.005 mm,
0 mm to 0.0005 mm, 0.5 mm to 0.05 mm, 0.5 mm to 0.005 mm, 0.05 mm
to 0.005. If the delivery device 220 is selected to be the haptic
speaker 220', then the portion of the haptic speaker 220' being
displaced is the coil of the haptic speaker.
[0179] In accordance with the present invention, it is contemplated
that each therapy providing device may be activated to provide
therapy for a time period between about 1 second and 24 hours. In
other embodiments, the therapy providing devices may be activated
to provide therapy for a time period of between about 1 second and
12 hours, 1 second and 11 hours, 1 second and 10 hours, 1 second
and 9 hours, 1 second and 8 hours, 1 second and 7 hours, 1 second
and 6 hours, 1 second and 5 hours, 1 second and 4 hours, 1 second
and 3 hours 1 second and 2 hours, and 1 second and 1 hour, 1 second
and 45 minutes, 1 second and 30 minutes, 1 second and 20 minutes, 1
second and 15 minutes, 1 second and 10 minutes, 1 second and 5
minutes and 1 second and 1 minute.
[0180] The overall therapy process may be conducted for a time
period between 1 second and 24 hours, 1 second and 23 hours, 1
second and 22 hours, 1 second and 21 hours, 1 second and 20 hours,
1 second and 19 hours, 1 second and 18 hours, 1 second and 17
hours, 1 second and 16 hours, 1 second and 15 hours, 1 second and
15 hours, 1 second and 14 hours, 1 second and 13 hours, 1 second
and 12 hours, 1 second and 11 hours, 1 second and 10 hours, 1
second and 9 hours, 1 second and 8 hours, 1 second and 7 hours, 1
second and 6 hours, 1 second and 5 hours, 1 second and 4 hours, 1
second and 3 hours, 1 second and 2 hours, 1 second and 1 hour, 1
second and 45 minutes, 1 second and 30 minutes, 1 second and 15
minutes, 1 second and 10 minutes, 1 second and 5 minutes, 1 second
and 1 minute.
[0181] In an alternative embodiment, instead of activating one
therapy providing device 200 at a time to conduct the therapy, both
therapy providing devices 200 may be activated at the same
time.
[0182] In accordance with the present invention, the therapy device
may be factory programmed to utilize a certain frequency or range
of frequencies to provide therapy. Alternatively, the frequencies
may be selected and programmed or chosen from memory by a health
care provider based upon a patient's response to a specific
frequency or range of frequencies.
[0183] It is further contemplated that the computing device may be
additionally in communication with other sensors, such as a blood
pressure monitor, heart rate monitor, pulse oximetry monitor,
electrocardiogram (EKG/ECG), or glucose sensor.
[0184] In one embodiment the computing device 800 would receive
data from the blood pressure monitor, or other sensor, such that
the user's blood pressure would be recorded before, during and
after the application of therapy in accordance with the present
invention. This data, along with the therapy data could be provided
to the user and/or a health care provider. Based upon the data, the
frequency or range of frequencies selected for therapy could be
adjusted. The adjustments may be made automatically by the program,
or by a health care provider or by the user themselves.
[0185] In another embodiment, the processor of the therapy
providing device 200 may be in communication with other sensors,
such as those described above, wherein the other sensors would be
coupled in communication with the therapy providing device. The
processor within the therapy providing device 200 can receive data
from various other sensors, such as a blood pressure monitor. The
data received from the blood pressure monitor may be utilized by
the program within the memory of the electronics module to further
control the therapy providing device 200.
[0186] The signals generated by the program and transmitted to the
therapy providing device are preferably in the form of a sine wave.
However, other wave forms may be utilized, such as a square
waveform, sawtooth waveform or triangle waveform.
[0187] It is further contemplated that additional sensors maybe
utilized with the methods and devices in accordance with the
present invention. For example, a blood pressure monitor may be
affixed to the patient as described above. Other sensors, such as a
sleep sensor, movement sensor, pulse oximetry sensor, temperature
sensor, heart rate monitor, EKG, microphone, digital stethoscope,
light sensor, sleep apnea device (CPAP) or camera may be used in
combination with the therapy system 100 in accordance with the
present invention. The sensors listed above could be used
separately or in combination to provide additional data to the user
or a health care provider as to the health of the user as well as
to the response of the user to the therapy provided by the therapy
system 100.
[0188] It is further contemplated that any of the above sensors
could be incorporated into the therapy providing device 200 in
accordance with the present invention. If incorporated into the
therapy providing device 200, the data from each of the additional
sensors could be utilized by the program to alter the therapy
provided based upon data received from the various sensors. In an
alternative embodiment, the data from each of the additional
sensors could be stored on the resident memory contained within the
therapy providing device 200. The therapy providing device 200
could then be turned into a service center after a period of time,
wherein the data contained within the memory can be retrieved and
analyzed. In yet another embodiment, the data stored within the
memory can be downloaded from the therapy providing device 200 each
time the therapy providing device is placed on the inductive
charging pad. The data can then be transmitted to a collection
center and analyzed. Additionally, the data could be uploaded to a
server or other internet/network connected personal computer, such
that the data could be viewed by the user, a health care provider
or others.
[0189] In another embodiment, the device will store the number of
uses and durations of usage to allow the health care practitioner
to determine compliance of the patient. As in sleep apnea devices,
reimbursement is only allowed if the patient is 70 percent
compliant, by tracking and recording the usage of the therapy
providing device of the present invention, this data could be
utilized for reimbursement purposes.
[0190] In another embodiment, the therapy system 100 of the present
invention could be associated with a home health system, such as
Honeywell's HomMed system. In this embodiment, the therapy system
100 in accordance with the present invention would be coupled to a
monitoring system. In this embodiment, a health care provider could
remotely monitor users as well as their response to the therapy
being provided. Further still, the therapy system 100 may be
configured to recognize an emergency, such as excessively high
blood pressure, excessively low blood pressure, high heart rate or
low heart rate and generate an alert, such as an alarm or
notification to an emergency response unit to request help for the
user.
[0191] In accordance with the present invention, the therapy device
200 as described herein is disposed adjacent to or thereabout the
clavicle just above the brachial plexus of the user. It is
contemplated that the therapy providing device 200 may be placed at
other locations on the user such as the sternum, jaw, scapula,
kneecap, wrist or skull. When activated, the driver assembly 220 of
the therapy device generates a frequency in the form of a sound
wave; this sound wave is transmitted to the clavicle and the skin
adjacent the clavicle. The sound waves transmitted to the clavicle
are transmitted in the form of vibrations. The vibrations travel
through the clavicle and into the skin, the arteries, vessels,
nerves, sensory corpuscles, airways, bones near the clavicle,
ligaments and tendons. As a result, the vibrations are eventually
transmitted to the baroreceptors, the nociceptors, the
proprioreceptors and other somatasory sensors. Here, the vibrations
interact with the baroreceptors and other sensors in a manner to
lower blood pressure. In a preferred embodiment, the clavicle is
chosen because it's easily accessible location as well as its
ability to transmit sound or vibrations. The clavicle is easy to
identify by a health care provider and a patient as it resides
close to the surface of the skin regardless of body mass.
[0192] In accordance with the methods and devices of the present
invention, activation of both the carotid and aortic baroreceptors
as well as other somatasory sensors can be achieved. It is believed
that activation of both the carotid and aortic baroreceptors is
beneficial in achieving lower blood pressure. It is believed that
the methods provided according to the present invention mimic
exercise, and therefore achieve a lowering of blood pressure.
[0193] In accordance with the invention, the therapy may be
provided at night time either right before the patient enters a
sleep cycle or during a sleep cycle of the patient. It may be
beneficial to provide the therapy in accordance with the present
invention at night time as it is believed that one of the most
important times to lower blood pressure is during the night. By
providing therapy at night time in accordance with the present
invention, the therapy can be utilized to address nighttime
hypertension. Additionally, at nighttime, systemic drug levels are
at their lowest, therefore there is a need for additional blood
pressure control at this time.
[0194] In accordance with another embodiment of the present
invention, it is believed that through the use of a single therapy
providing device instead of two therapy providing devices can be
utilized to lower only Diastolic blood pressure, wherein the use of
both therapy providing devices can be utilized to lower both
Systolic and Diastolic blood pressure.
[0195] In accordance with the invention, the therapy may be
provided prior to a users sleep cycle and again in the morning
either before they awake or shortly after they have woken up.
[0196] In accordance with the invention, the therapy providing
device may be programmed with frequencies, wherein other
frequencies may be utilized to raise blood pressure at such times
whereby raising the blood pressure would be therapeutic and
beneficial to a patient. It may be desirable to raise blood
pressure after childbirth or to counteract episodes of
hypotension.
[0197] It is further contemplated that the device and methods
according to the present invention may be utilized at any time. For
example, it may be desirable to utilize the device during the day
time, where the device could be utilized in combination with a
blood pressure monitor, or alternatively, incorporate a blood
pressure monitor for closed loop control. In this embodiment, the
program would monitor the user's blood pressure and apply therapy
on an as needed basis. The user could select to turn the system off
if desired, for example if they are planning to engage in physical
activity which will raise their blood pressure.
Test Results
[0198] In accordance with the present invention, and referring to
FIGS. 24A and 24B, the following blood pressure results were
achieved through use of the device and methods described herein.
FIGS. 24A and 24B illustrate ambulatory blood pressure readings
over a 24 hour period. Line 910 is the European Society of
Hypertension (ESH), the UK National Institute for Health and
Clinical Excellence (NICE) and American Society of Hypertension
(ASH) recommended limits for Systolic blood pressure. Between the
hours of 10 pm and 7 am a blood pressure of below 125 mmHg is
considered to be at goal. During the daytime between the hours of 7
am and 10 pm, a blood pressure below 140 mmHg is considered to be
at goal. Line 930 is the ESH, NICE and ASH recommended limits for
Diastolic blood pressure, similar to the Systolic line 910, between
the hours of 10 pm and 7 am an at-goal Diastolic pressure is
considered to be 80 mmHg, and between the hours of 7 am to 10 pm a
measurement of 90 mmHg is considered to be at goal.
[0199] As shown in FIG. 24A, lines 900 and 920 represent
twenty-four (24) hour ambulatory blood pressure measurements of an
individual, wherein blood pressure measurements were taken every
fifteen (15) minutes. The user presented in FIG. 24B would be
considered to be hypertensive, that is to have high blood pressure.
This can be determined by looking specifically at lines 900 and
lines 920, wherein any time these lines are above the recommend
guideline pressures, lines 910 and 930 the user would be considered
to be hypertensive.
[0200] Referring now to FIG. 24A there is shown a graph of the same
user after having received therapy in accordance with the present
invention. In this instance, the user received therapy at twice for
two hours (2 hours) each time as depicted items 940 and 950.
Comparing the user's actual blood pressure measurements, lines 900
and 920 of FIG. 24A, with the user's treated actual blood pressure
measurements, lines 901 and 902 of FIG. 24A, it can be clearly seen
that the user's blood pressure was significantly lowered through
the application of therapy utilized the device and methods of the
present invention.
[0201] To achieve the results depicted in FIG. 24A, two therapy
providing devices were utilized, one on the left clavicle and one
on the right clavicle. A frequency between 60 and 100 Hz was
delivered by the speaker of each therapy providing device. The
therapy providing devices were utilized for a total of 4 hours of
therapy, wherein the frequency of 65 Hz was played for 8 seconds,
followed by a sweep of frequencies from 65 Hz to 98 Hz lasting 1
second, afterwards 98 Hz was played for 8 seconds, followed by a
sweep of frequencies from 98 Hz to 65 Hz lasting for 1 second.
Therapy was provided, repeatedly for 120 minutes following this
cycle. After 120 minutes the therapy was suspended for a period of
4 hours. After 4 hours of silence, an additional 120 minutes of
therapy was delivered utilizing the cycle above.
[0202] Blood pressure measurements were taken before the
application of the therapy, whereby the user's Systolic blood
pressure averaged 131 mmHg at night time and 144 mmHg during the
day. Diastolic blood pressure was 72 mmHg at night time and 87 mmHg
during the day. After using the therapy for one evening (one 8 hour
session as described above), Systolic blood pressure averaged 116
mmHg at nighttime and 131 mmHg at daytime and diastolic blood
pressure averaged 66 mmHg at nighttime and 80 mmHg at daytime.
Method of Action
[0203] In accordance with the present invention, as described in
detail above and with reference to the included publications, it is
understood that baroreceptors and nerves affect blood pressure
through a measured response generated by stretching or contraction
of the arterial wall.
[0204] Nerve fibers, including baroreceptors, have the following
input-output characteristics; threshold pressure, saturation,
post-excitory depression (PED), Asymmetric Rate Sensitivity and
hysteresis.
[0205] As long as pressure within an artery remains below a certain
level, no nerve firing occurs, this is referred to as the nerve
threshold pressure. Above the threshold pressure, the fiber
responds by producing action potentials, i.e. as signal. Individual
fibers within humans and animals possess a wide range of pressure
threshold values.
[0206] As pressure increases within the artery, the firing rate of
individual fibers increases. However, at certain pressure, further
increases in input yield no further increase in output frequency,
thereby reaching the saturation of the baroreceptor nerve.
[0207] If pressure input within the artery is stepped from a low
pressure, which is higher than the threshold pressure, to a higher
pressure, then returning to a lower pressure level, will result in
a brief period of shutoff, that is there will be no firing of the
baroreceptor nerve, also referred to as post-excitatory depression
(PED). The baroreceptor nerve will return to its original firing
rate after time.
[0208] Baroreceptor nerve frequency response to rising pressure is
more pronounced than the response to falling pressure, otherwise
known as asymmetric rate sensitivity.
[0209] Lastly, periodic inputs produce looping in
pressure-frequency plots, another indication of the asymmetry
between responses to rising and falling pressures otherwise
referred to as hysteresis.
[0210] In accordance with the present invention, utilization of the
devices in accordance with the methods described herein cause an
activation of the nervous system which affect blood pressure. The
nerve terminal endings respond to stretch or acoustic vibration,
and produce a frequency-modulated train of action potentials which
can override the natural frequencies to elicit a response. Wherein
the therapy provided by the invention, utilizes acoustic vibration
of specific frequencies applied at specific time intervals to
activate the body's nervous system to elicit a blood pressure
response. The therapy of the present invention is applied in a
cyclic manner as it is believed that the baroreceptors may become
saturated if stimulated for too long of a period of time. If the
therapy was applied continuously it is believed that the
baroreceptors would stop responding.
[0211] According to a method of the present invention, the therapy
providing device is disposed adjacent to a user's clavicle. The
clavicle being a Dermal bone, is capable of transmitting
vibrations. The clavicle lies above the cerviocoaxillary which
holds auxiliary arteries, veins, airways and the brachial plexus of
nerves that supply the upper limb of the arm. Vibrating the
clavicle is believed to create micro-pulsations which travel to the
Aortic Baroreceptors and the Carotid Bulb Baroreceptors. These
micro-pulsations are believed to be perceived as an increase in
heart rate by the baroreceptors which then send a signal to the
brain. Thereby causing the body to lower blood pressure.
[0212] Selective stimulation of primary nerve endings can be
obtained with careful control of the amplitude, displacement and
the mode of application of the vibration or micro-pulsations.
* * * * *