U.S. patent application number 16/802775 was filed with the patent office on 2020-11-05 for modular stimulus applicator system and method.
The applicant listed for this patent is CAREWAVE MEDICAL, INC.. Invention is credited to Charles Chabal, Peter J. Dunbar.
Application Number | 20200345537 16/802775 |
Document ID | / |
Family ID | 1000004961040 |
Filed Date | 2020-11-05 |
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United States Patent
Application |
20200345537 |
Kind Code |
A1 |
Dunbar; Peter J. ; et
al. |
November 5, 2020 |
MODULAR STIMULUS APPLICATOR SYSTEM AND METHOD
Abstract
A modular stimulus applicator system and method are disclosed.
The system includes a plurality of wirelessly controlled stimulus
pods, anchored to a patient's body, and configured to deliver
stimulus to the patient's body. The stimulus can be heat,
vibration, or electrical stimulus, or any combination thereof. The
stimulus pods are controlled by a control station that can include
a user-interface through which the patient can control application
of the stimulus.
Inventors: |
Dunbar; Peter J.; (Mercer
Island, WA) ; Chabal; Charles; (Bellevue,
WA) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
CAREWAVE MEDICAL, INC. |
Seattle |
WA |
US |
|
|
Family ID: |
1000004961040 |
Appl. No.: |
16/802775 |
Filed: |
February 27, 2020 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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13981081 |
Apr 1, 2014 |
10603208 |
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PCT/US12/22252 |
Jan 23, 2012 |
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16802775 |
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61435221 |
Jan 21, 2011 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61H 2201/5092 20130101;
A61N 1/0408 20130101; A61F 2007/0086 20130101; A61H 2205/081
20130101; A61H 2201/5007 20130101; A61F 2007/0095 20130101; A61N
1/0428 20130101; A61H 2230/505 20130101; A61H 2201/0207 20130101;
A61H 2201/10 20130101; A61H 2201/165 20130101; A61H 2201/5028
20130101; A61N 1/36021 20130101; A61H 23/02 20130101; A61F 7/007
20130101; A61H 2201/5082 20130101; A61H 2201/1623 20130101; A61N
1/0456 20130101; A61H 2201/0176 20130101; A61N 1/0476 20130101;
A61H 1/00 20130101; A61H 2201/1614 20130101; A61F 2007/0078
20130101; A61H 2201/5097 20130101; A61N 1/044 20130101; A61H
2201/5046 20130101; A61H 2205/062 20130101; A61N 1/322
20130101 |
International
Class: |
A61F 7/00 20060101
A61F007/00; A61N 1/04 20060101 A61N001/04; A61N 1/36 20060101
A61N001/36; A61H 1/00 20060101 A61H001/00 |
Goverment Interests
STATEMENT OF GOVERNMENT INTEREST
[0002] The U.S. Government has a paid-up license in this invention
and the right in limited circumstances to require the patent owner
to license others on reasonable terms as provided for by the terms
of grants 1R43CA099305-01A2, 2R44CA099305-02 and 2R44CA099305-03
awarded by the National Institutes of Health.
Claims
1-6. (canceled)
7. A therapeutic stimulus application system, comprising: a
plurality of stimulus pods, individual stimulus pods comprising a
battery, a first communication link, and a stimulus delivery
surface for application to selected portions of a human body
through which stimulus is applied to the portions of the human
body; a base comprising a plurality of sockets configured to
receive the stimulus pods, wherein the individual sockets comprise
a power transmission mechanism through which electrical power is
transferred to the battery of individual stimulus pods when the
stimulus pods are positioned in the socket; and a control station
comprising a second communication link configured to communicate
with the first communication link of individual stimulus pods, and
an input device through which input commands are received, wherein
the control station instructs the stimulus pods to deliver the
stimulus to the human body according to the input commands.
8. The therapeutic heat application system of claim 7 wherein the
control station and the base are part of a single unit.
9. The therapeutic heat application device of claim 7 wherein
individual stimulus pods comprise a disk-shaped device
approximately one inch in diameter, and wherein the stimulus pods
are held to the human body by an anchor.
10. The therapeutic stimulus application system of claim 7 wherein
the plurality of stimulus pods comprises at least one index
stimulus pod and at least one dummy stimulus pod, and wherein the
index stimulus pod is configured to communicate between the dummy
stimulus pod and the control station.
11. The therapeutic stimulus application system of claim 7 wherein
the stimulus comprises heat, the system further comprising a
thermal limiter comprising at least one temperature sensor, the
thermal limiter being in communication with the plurality of
stimulus pods to instruct the stimulus pods to cease applying heat
if the temperature sensor detects a temperature above a
predetermined threshold temperature.
12. The therapeutic stimulus application system of claim 11 wherein
the thermal limiter comprises a thermal fuse that interrupts power
to the stimulus delivery surface if the temperature sensor detects
a temperature above the predetermined threshold temperature.
13. The therapeutic stimulus application system of claim 7 wherein
the control station comprises a portable electronic device.
14. The therapeutic stimulus application system of claim 7 wherein
the power transmission mechanism comprises an induction charger,
and wherein the stimulus pods comprise an induction charge receiver
that transfers energy from the induction charger to the
battery.
15. The therapeutic stimulus application system of claim 7 wherein
the power transmission mechanism comprises a conductive charger,
and wherein the stimulus pods comprise a jack for connection to the
conductive charger.
16. The therapeutic stimulus application system of claim 7, further
comprising a memory for storing a sequence of operations for the
stimulus pods.
17. The therapeutic stimulus application system of claim 16 wherein
the sequence of operations comprises a combination of ramp up
operations, maximum stimulus intensity operations, ramp down
operations, stimulus soak operations, and lockout period
operations.
18. The therapeutic stimulus application system of claim 17
wherein: the ramp up operations comprise gradually increasing a
temperature applied through the heating surface of the stimulus
pods; the maximum stimulus intensity operations comprise
maintaining the stimulus at a predetermined maximum energy level;
the ramp down operations comprise gradually decreasing the
stimulus; the stimulus soak operations comprise maintaining the
stimulus at a predetermined soak stimulus level below the
predetermined maximum energy level; and wherein the lockout period
operations comprise interrupting stimulus from the stimulus
pods.
19. The therapeutic stimulus application system of claim 17 wherein
the input device receives a selection from between ramp up
operations, maximum temperature operations, ramp down operations,
temperature soak operations, and lockout period operations.
20. The therapeutic stimulus application system of claim 17 wherein
the stimulus pods execute the lockout period for a predetermined
time interval in response to at least one of: a temperature
exceeding a predetermined threshold temperature; an energy delivery
level exceeding a predetermined threshold energy delivery level;
and the stimulus applying stimulating the heating surface for more
than a predetermined time threshold.
21. A method, comprising locating a plurality of wireless stimulus
pods relative to a patient's body; determining a treatment plan for
stimulus delivery to the patient's body through the stimulus pods,
including at least one of a ramp up operation, a ramp down
operation, a stimulus soak operation, and a lockout period; and
receiving operator input directing application of the stimulus to
the plurality of stimulus pods, including a selection from among
the ramp up operation, the ramp down operation, the stimulus soak
operation, and the lockout period; and instructing the stimulus
pods to deliver the stimulus according to the treatment plan and
the operator input.
22. The method of claim 21 wherein locating the plurality of
wireless stimulus pods comprises wirelessly receiving an indication
of location from the stimulus pods at a control station.
23. The method of claim 21 wherein receiving the operator input
comprises receiving input through a user-interface of a control
station, and wherein instructing the stimulus pods comprises
instructing the stimulus pods from a control station to deliver the
stimulus.
24. The method of claim 21 wherein the stimulus comprises at least
one of heat, vibration, and electrical stimulus.
25. The method of claim 21, further comprising detecting an energy
delivery level and comparing the energy delivery level to a
predetermined threshold, wherein the lockout period is applied if
the energy delivery level exceeds the predetermined threshold.
26. The method of claim 25 wherein the stimulus comprises at least
one of heat, vibration, and electrical stimulus, and wherein the
predetermined threshold includes a first threshold for heat, a
second threshold for vibration, and a third threshold for
electrical stimulus.
27. The method of claim 25 wherein the stimulus is heat, the method
further comprising detecting a temperature of the stimulus pods,
and wherein the lockout period continues until the temperature of
the stimulus pods falls below a predetermined threshold
temperature.
28. The method of claim 21 wherein the lockout period is triggered
after the stimulus has been continually applied for more than a
predetermined threshold time.
29. The method of claim 21, further comprising positioning the
stimulus pods on the patient's body on or near a source of
pain.
30. The method of claim 21 wherein locating the wireless stimulus
pods and instructing the stimulus pods comprises communicating from
a base station to an index stimulus pod and from the index stimulus
pod to at least one dummy stimulus pod.
31. The method of claim 21 wherein locating the plurality of
wireless stimulus pods relative to the patient's body comprises
determining an area of the patient's body directly contacted by a
stimulus pod, and determining an area of effect not directly
contacted by the stimulus pod but within an effective region of the
stimulus pod.
32. The method of claim 31 wherein the area of effect varies
according to positions on the patient's body.
33. The method of claim 31 wherein the size of the area of effect
is generally inversely proportional to a nerve density of the
patient's body contacting the stimulus pod.
Description
CROSS REFERENCE TO RELATED APPLICATIONS
[0001] This application is a division of U.S. patent application
Ser. No. 13/981,081 which was filed on Apr. 1, 2014, which was 371
U.S. national phase of international application PCT/US12/22252,
filed Jan. 23, 2012, which claims the benefit of priority to U.S.
Provisional Patent Application No. 61/435,221, filed on Jan. 21,
2011, all of which are hereby incorporated by reference in their
entirety.
TECHNICAL FIELD
[0003] The following disclosure relates generally to stimulus-based
therapeutic devices, systems, and methods. In particular, the
disclosure relates to systems and methods for applying heat,
vibration, electrical, and other stimulus to a patient's body for
therapeutic purposes.
BACKGROUND
[0004] In 1965, Melzack and Wall described the physiologic
mechanisms by which stimulation of large diameter non-pain sensory
nerves could reduce the amount of unpleasant activity carried by
pain nerves. This landmark observation published in Science was
termed the "gate control theory" and offered a model to describe
the interactions between various types of the sensory pathways in
the peripheral and central nervous systems. The model described how
non-painful sensory input such as mild electrical stimulation could
reduce or gate the amount of nociceptive (painful) input that
reached the central nervous system.
[0005] The gate-control theory stimulated research that lead to the
creation of new medical devices such as transcutaneous electrical
nerve stimulators (TENS). In brief, TENS works by electrically
"blocking" pain impulses carried by peripheral nerves. Receptors to
cold and heat are located just below the surface of the skin. Heat
receptors are activated through a temperature range of about
36.degree. C. to 45.degree. C. and cold receptors by a temperature
range about 1-20.degree. C. below the normal skin temperature of
34.degree. C. (Van Hees and Gybels, 1981). The stimuli are
transmitted centrally by thin poly-modal C nerve fibers. Activation
of heat receptors are also affected by the rate of rise of the heat
stimuli (Yarnitsky, et al., 1992). Above 45.degree. C. warm
receptor discharge decreases and nociceptive response increases
producing the sensations of pain and burning (Torebjork et al.,
1984).
[0006] Activation of poly-modal thermal receptors causes
significant pain relief in controlled experimental conditions.
Kakigi and Watanabe (1996) demonstrated that warming and cooling of
the skin in human volunteers could significantly reduce the amount
of reported pain and somatosensory evoked potential activity
induced by the noxious stimulation of a CO2 laser. The authors
offered that the effects seen could be from a central inhibitory
effect produced by the thermal stimulation. Similar inhibition of
pain from thermal simulation was reported in a different Human
experimental pain model (Ward et al., 1996). The study authors
(Kakigi and Watanabe 1996 and Ward et al., 1996) proposed that the
thermal analgesia was in part from a central inhibitory effect
(gating) from stimulation of small thin C nerve fibers. This
contrasts with TENS which produces at least part of its analgesia
through gating brought on by activation of large diameter afferent
nerve fibers.
[0007] A number of recent clinical studies strongly support the use
of heat as an analgesic in patients who suffer from chronic pain
and offer potential mechanisms by which heat produces analgesia.
Abeln et al. (2000) in a randomized controlled single-blinded study
examined the effect of low level topical heat in 76 subjects who
suffered from low back pain. Heat treatment was statistically more
effective in relieving pain and improving the quality of sleep than
that produced by placebo.
[0008] Weingand et al. (2001) examined the effects in a randomized,
single blinded, controlled trial of low level topical heat in a
group of over 200 subjects who suffered from low back pain and
compared heat to placebo heat, an oral analgesic placebo, and
ibuprofen 1200 mg/day. The authors found heat treatment more
effective than placebo and superior to ibuprofen treatment in
relieving pain and increasing physical function as assessed by
physical examination and the Roland Morris disability scale.
[0009] A separate group (Nadler at al, 2002) found similar results
in a prospective single blinded randomized controlled trial of 371
subjects who suffered from acute low back pain. The authors found
that cutaneous heat treatment was more effective than oral
ibuprofen 1200 mg/day, acetaminophen 4000 mg/day or oral and heat
placebos in producing pain relief and improving physical function.
The authors offered several hypotheses for the mechanism(s) of
action which includes increased muscle relaxation, connective
tissue elasticity, blood flow, and tissue healing potential
provided through the low-level topical heat. Similar beneficial
effects of topical heat were show in patients who suffered from
dysmenorrhea (Akin et al., 2001), and temporomandibular joint pain
TMJ (Nelson et al., 1988).
[0010] A recent study used power Doppler ultrasound to evaluate the
effects of topical heat on muscle blood flow in Humans (Erasala et
al., 2001). Subjects underwent 30 minutes of heating over their
trapezius muscle and changes in blood flow were examined at 18
different locations over the muscle. Vascularity increased 27%
(p=0.25), 77% (p=0.03) and 104% (p=0.01) with 39, 40 or 42.degree.
C. temperature of the heating pad. Importantly increases in blood
flow extended approximately 3 cm deep into the muscle. The authors
concluded that the increased blood flow likely contributed to the
analgesic and muscle relaxation properties of the topical heat.
Similar increases in deep vascular blood flow were noted using
magnetic resonance thermometry in subjects treated with mild
topical heat by two separate groups (Mulkern et al., 1999, and Reid
et al., 1999).
[0011] Recent studies demonstrating the analgesic effectiveness of
heat and provided potential mechanisms of action. The mechanisms
include a reduction of pain through a central nervous system
interaction mediated via thin c-fibers (Kakigi and Watanabe, 1996,
Ward et al. 1996), enhancement of superficial and deeper level
blood flow (Erasala et al., 2001, Mulkern et al., 1999, Reid et
al., 1999), or local effects on the muscle and connective tissue
(Nadler et al., 2002, Akin et al. 2001). TENS is thought to act
through inhibition of nociception by increasing endogenous opioids
or by a neural inhibitory interaction of nociception via large
diameter fibers. It is likely that TENS and heat act partly through
different mechanisms with the potential for enhanced or even
synergistic interactions. TENS is widely used and endorsed by the
pain management guidelines of both the AHCPR and American Geriatric
Society (Gloth 2001). However a significant number of patients fail
to achieve adequate relief with TENS or fail within six months of
starting treatment (Fishbain et al., 1996).
BRIEF DESCRIPTION OF THE DRAWINGS
[0012] FIG. 1A is an isometric view of a heat pod and anchor
according to embodiments of the present disclosure.
[0013] FIG. 1B is an exploded view of a heat pod according to
embodiments of the present disclosure.
[0014] FIG. 2 is an exploded view of an anchor according to
embodiments of the present disclosure.
[0015] FIGS. 3A-3C illustrate various attachment means between a
stimulus pod and anchor according to embodiments of the present
disclosure.
[0016] FIG. 4 shows various attachment means between a stimulus pod
and anchor according to embodiments of the present disclosure.
[0017] FIG. 5A is an isometric view of a non-contact charging
station according to embodiments of the present disclosure.
[0018] FIG. 5B is a partially exploded view of a charging and/or
control station according to embodiments of the present
disclosure.
[0019] FIG. 5C is an isometric view of a contact charging station
according to embodiments of the present disclosure.
[0020] FIG. 6 is a partially schematic view of index stimulus pods
and dummy stimulus pods, and a control station according to several
embodiments of the present disclosure.
[0021] FIG. 7A is a graph of distribution of preferred pod
temperature.
[0022] FIG. 7B is a graph of comfort values for different
temperatures.
[0023] FIG. 7C is a graph of thermal sensation values for different
temperatures.
[0024] FIG. 7D is a graph of temperature "liking" values.
[0025] FIG. 8A is a flow diagram illustrating clinical trial
procedures.
[0026] FIG. 8B is a graph comparing Iowa Pain Thermometer scales
for different PMS pain treatments.
[0027] FIG. 8C is a graph comparing Numerical Rating Scales for
different PMS pain treatments.
[0028] FIG. 9A is a graph comparing Iowa Pain Thermometer scales
for different lower back pain treatments.
[0029] FIG. 9B is a graph comparing Numerical Rating Scales for
different lower back pain treatments.
DETAILED DESCRIPTION
[0030] The present disclosure is directed generally to apparatuses,
devices and associated methods for applying heat to various parts
of the human body using a series of modular pods. The pods can be
controlled by a remote controller in the form of a computer (a
desktop or a laptop computer), or a mobile device such as a mobile
phone, tablet or MP3 player. The pods can releasably attach to
disposable rings that adhere to the body at various locations to
which the patient desires to direct heat therapy.
[0031] Several details describing thermal and electrical principles
are not set forth in the following description to avoid
unnecessarily obscuring embodiments of the disclosure. Moreover,
although the following disclosure sets forth several embodiments of
the invention, other embodiments can have different configurations,
arrangements, and/or components than those described herein without
departing from the spirit or scope of the present disclosure. For
example, other embodiments may have additional elements, or they
may lack one or more of the elements described below with reference
to FIGS. 1-6.
[0032] FIG. 1A is an illustration of a stimulus pod system 100 in
accordance with several embodiments of the present disclosure. The
system 100 can include a stimulus pod 110 and an anchor 120. The
stimulus pod 110 can be approximately 1'' in diameter, and can be
equipped to deliver different stimuli to the patient's body,
including heat, vibration, and electricity. In some embodiments,
the pods 110 can include sensors that gather information and relay
the information back to a control station. Throughout this
disclosure the stimulus pods 110 are referred to interchangeably as
stimulus pods 110, pods 110, or other types of pods 110 without
loss of generality. The anchor 120 can have an adhesive surface
that can be applied to various locations on a patient's body, an
aperture 122, and an attachment ring 124 that can engage the pod
110 to hold the pod 110 onto the patient's body. Additionally or
alternatively, pods 110 can be kept in place by clothing, magnets,
Velcro-type applicator, elastic bands, pocket-like holders, braces,
or other type of applicators capable of holding the pod against the
patient's skin. The pod 110 can be a stimulus pod 110 that has a
heating surface 150 that contacts the patient's body to deliver
stimulus in a measured, deliberate pattern to relieve pain and
discomfort in the patient's body. Several of the stimulus pods 110
can be used in concert at different places on the patient's
body.
[0033] The stimulus pods 110 can also be used to deliver medicine
to a patient through electrophoresis or iontophoresis.
Electrophoresis is the motion of dispersed particles relative to a
fluid under the influence of a spatially uniform electric field.
Electrophoresis is ultimately caused by the presence of a charged
interface between the particle surface and the surrounding fluid.
Iontophoresis (a.k.a. Electromotive Drug Administration (EMDA)) is
a technique using a small electric charge to deliver a medicine or
other chemical through the skin. It is basically an injection
without the needle. The technical description of this process is a
non-invasive method of propelling high concentrations of a charged
substance, normally a medication or bioactive agent, transdermally
by repulsive electromotive force using a small electrical charge
applied to an iontophoretic chamber containing a similarly charged
active agent and its vehicle. One or two chambers are filled with a
solution containing an active ingredient and its solvent, also
called the vehicle. The positively charged chamber (anode) will
repel a positively charged chemical, whereas the negatively charged
chamber (cathode) will repel a negatively charged chemical into the
skin.
[0034] FIG. 1B is an exploded view of a stimulus pod 110 in
accordance with several embodiments of the present disclosure. The
stimulus pod 110 can include a stimulus surface 150 that contacts
patient's skin to deliver heat, mild electrical stimuli, vibration,
and/or other stimuli to the patient's body. The stimulus pod 110
can also include a battery 155, a circuit board 160, a charging
coil 165, and several housing elements 170. The battery 155 can
power the stimulus surface and the circuit board 160. The battery
155 can be a lithium polymer battery or another suitable battery
type. The charging coil 180 can be configured to receive power from
a power source and deliver the power to the battery 155. The
stimulus pod 110 can include a wireless communication link 175
through which the stimulus pod 110 receives instructions and/or
sends data to and from a control station (described in greater
detail below). The housing elements 170 can include an upper cover
170a and a body 170b that enclose the internal components and
provide a convenient handling surface. The stimulus pods 110 can
include attachment means to attach the stimulus pod 110 to the
anchor 120. For example, the stimulus pod 110 can have metal slugs
105 that can be magnetized and coupled to a metallic attachment
ring 124 in the anchor 120 to hold the stimulus pod 110 to the
anchor 120. The slugs 105 can also be used for stimulus delivery.
In selected embodiments, the metal slugs 105 can be positioned on a
top side of the stimulus pods 110 and can be used to interface with
a charging station discussed in more detail below.
[0035] FIG. 2 shows an anchor 120 as assembled, and in an exploded
view in accordance with several embodiments of the present
disclosure. The anchor 120 can include an upper surface 130, an
attachment ring 124, an adhesive layer 135, and a liner 140. The
liner 140 can be removed to expose the adhesive layer 135 before
placing the anchor 120 on the patient's body. The upper surface 130
is exposed to the ambient conditions and accordingly can be similar
to a bandage or a wound covering to provide a clean,
water-resistant surface for the anchor 120. Beneath the upper
surface 130, the attachment ring 124 can include a metallic ring
such as a steel ring that corresponds to magnets 185 in the
stimulus pod 110. The ring 124 is held to the upper surface 130 by
the adhesive layer 135, which can have an adhesive on the upper
side to adhere to the ring 124 and the upper surface 130, and on
the lower side to adhere to the liner 140. The materials can all be
rigid enough to maintain a proper shape, but flexible enough to
substantially conform to the patient's body. For example, the ring
124 can be segmented or thin to permit the anchor 120 to flex to
some degree. Once the anchor 120 is in its place on the body, the
stimulus pod 110 can be placed into the aperture 122 in the anchor
and held in contact with the patient's body to deliver heat and/or
other stimulants to the patient.
[0036] FIGS. 3A-3C illustrate several embodiments in accordance
with the present disclosure including various attachment means
between the anchor 120 and the stimulus pod 110. In many
applications, the stimulus from the stimulus pod 110 is best
delivered to the patient's body with a stimulus surface 150
directly contacting the patient's skin. The anchor can take
different forms to keep the stimulus surface 150 against the
patient's skin, some of which are shown using the cross-sectional
views of FIGS. 3A-3C. FIG. 3A shows a stimulus pod 110 having a
plug 152a that extends slightly beyond the anchor 120. The plug
152a can have a stimulus surface 150a with a flat profile. The
attachment ring 124 can engage the stimulus pod 110 with sufficient
force that the stimulus surface 150a presses down onto the
patient's skin to ensure sufficient contact with the skin. FIG. 3B
shows an alternative embodiment including a plug 152b with a
stimulus surface 150b that is convex. The slope of the convex
stimulus surface 152b can depend in part on the application and
size of the stimulus pod 110. The convex stimulus surface 150b can
have more surface area than the flat stimulus surface 150a,
provided that the slope is not too extreme such that portions of
the stimulus surface 150b do not contact the patient's skin. FIG.
3C illustrates yet another embodiment including a plug 152c that
similarly extends beyond the anchor 120, and has a stimulus surface
150c. In this embodiment, the stimulus surface 150c has several
small bumps or projections 240. The dimensions of the stimulus
surface 150c and the bumps 240 can be chosen to increase the
surface area of the stimulus surface 150c that contacts the
patient's skin without creating void spaces or air pockets between
the bumps 240 that might reduce effective heat transfer or delivery
of other stimuli. In some embodiments, the projections 240 are not
discrete, but are continuous and/or sinusoidal.
[0037] FIG. 4 illustrates several embodiments of the present
disclosure in which the attachment means between the anchor 120a
and the stimulus pod 110 include various attaching mechanisms. FIG.
3A contains several magnified views of a region marked "A" which
depicts the interface between the anchor 120a and the stimulus pod
110. In some embodiments, the anchor 120a contains a metallic or
magnetic ring 250 that corresponds to a magnet 185 in the stimulus
pod 110. The magnetic force between the ring 250 and the magnets
185 hold the stimulus pod 110 in place relative to the anchor 120a.
In other embodiments, an anchor 120b can be held to the stimulus
pod 110 by a mechanical fastener 255 such as a snap, or other
similar mechanical attachment means. In some embodiments, the
attachment mechanism can operate along the same principle as a
plastic cap on a cardboard cup, such as a coffee cup and lid.
Either the stimulus pod 110 or the anchor 120b can contain a
resilient recession and the other can contain a matching, resilient
projection that, when pressed together, mechanically hold the
stimulus pod 110 in place on the anchor 120b. In still other
embodiments, a hook-and-loop fastener 260 can be used. Other
embodiments use the interior surface 265 of an anchor 120d and a
corresponding, resilient exterior surface 270 of a plug 152d that
can be pressed into the aperture 122 of the anchor 120 and snap
into place. Yet another embodiment includes opposing threaded
surfaces on an anchor 120e and a plug 152e such that the stimulus
pod 110 can be screwed into the anchor 120 with a stimulus surface
150e protruding beyond the anchor 120e to ensure proper contact
with the patient's skin. In other embodiments, an anchor 120f can
include a keyed aperture 122 having an irregular interior surface
265, and a plug 152f of the stimulus pod 110 can include a
correspondingly irregular external surface 270 that can be placed
over the aperture 122 and rotated slightly with portions of the
irregular exterior surface 270 engaging with the anchor 120f to
hold the stimulus pod 110 in place.
[0038] Any of the attachment mechanisms provide a simple way for a
patient to apply a stimulus pod 110 to their body. The stimulus
pods 110 can be interchangeable between anchors 120, and vice
versa. A patient can use a stimulus pod 110 until the battery is
depleted, and then simply swap in another stimulus pod 110 with a
fresh battery. The attachment means can be strong enough and the
dimensions of the stimulus pod 110 can be small enough that the
stimulus pod 110 can be worn under the patient's clothing easily.
The placement of the anchors 120 can vary greatly according to a
predetermined diagnostic pattern or personal preference. In some
embodiments, the stimulus pods 110 can be placed at an area of
discomfort, such as a painful lower back. Some research suggests
that placing additional stimulus pods 110 at an area remote from a
problem area can also provide analgesic effects. For example, a
patient may use a stimulus pod 110 at the lower back--where the
pain is--but they can also use a secondary stimulus pod 110 near
the shoulders or on the legs. Multiple stimulus pods 110 can be
used in concert to produce an aggregate affect. As different areas
of the human body have different nerve densities, in certain areas
two stimulus pads 110 placed near one another are perceived as a
single, large stimulus pad 110. For example, the patient's back has
much lower nerve density than the face, neck, or arms. Accordingly,
the patient can use a pair of small stimulus pads 110 (e.g., one or
two inches in diameter) at the lower back spaced about three or
four inches apart and achieve the same sensory result as a larger
stimulus pad covering the entire area. An unexpected benefit of
this arrangement is that much less power is required to provide the
stimulus in two small areas than would be required to stimulate the
entire area.
[0039] FIGS. 5A and 5B illustrate a charging station 200 according
to several embodiments of the present disclosure. FIG. 5A shows a
charging station 200 including several sockets 205 shaped to
receive a single stimulus pod 110. In the embodiment shown, the
charging station 200 includes four sockets 205. Other
configurations can have a different number of sockets 205. FIG. 5B
is a partially exploded view of the charging station, which can
include a charging coil 210 and a circuit board 215 under each
socket 205. The charging station 200 can also include an electrical
connector 220 that can be plugged into a standard electrical outlet
or other power source to provide power to the charging station 200.
The charging station 200 can detect when a stimulus pod 110 is
seated in the socket 205 through a wireless signal, a proximity
sensor, or because the pods 110 depress a button in the sockets
205. When the stimulus pods 110 are on the charging station 220,
the corresponding circuit board 215 can instruct the charging coil
210 to transmit power to the charging coil 180 of the stimulus pod
110. In some embodiments, the stimulus pods 110 can have an
asymmetric shape that matches a corresponding, negative shape in
the sockets 205 to ensure proper alignment with the sockets 205.
The pods 110 can include a contact point that can be used for
charging the pods 110 or as control inputs for the pods 110. In
another embodiment, the stimulus pods 110 can include contacts on a
topside (e.g., on the upper cover 170a) through which the pods 110
can exchange electrical power and communication signals when placed
on the sockets 205 with the upper cover 170a face-down. Several
details of the electrical arrangement of the charging station 200,
such as wires and other electrical connectors, have not been shown
to avoid obscuring features of the present disclosure.
[0040] The charging station 200 can include a light 225 that can
indicate that the charging station 200 is transmitting power to a
stimulus pod 110. When the battery 155 of the stimulus pod 110 is
fully charged, the stimulus pod 110 can notify the charging station
200 which can then cease charging the battery 155 and change the
light 225 to indicate that the battery 155 is fully charged and is
ready for use. When there are several stimulus pods 110 having
different power levels in different sockets 205, the charging
station 200 can charge the stimulus pods 110 that have less than a
full charge while not powering the stimulus pods 110 that have a
more full charge.
[0041] FIG. 5C shows a charging station 211 according to several
embodiments of the present disclosure. The illustrated charging
station 211 has two sockets 205 for receiving stimulus pods 110,
but a charging station with just one or more than two sockets 205
is also possible. The charging station 211 can be plugged into a
standard electrical outlet using a cord 212. Sockets 205 have
socket connectors 214 that mate with pod connectors 209 when a pod
is inserted into a socket. Sockets 205 can have a notch 213 to
accommodate an on/off switch 207 on the stimulus pod 110. The notch
213 can also serve as a keying feature to assure proper alignment
of the socket connectors with the pod connectors 209.
[0042] FIG. 5C further shows the stimulus pods 110 having the pod
connectors 209 either on the lower surface of the pod (as shown in
the upper view of the stimulus pod 110) or on the upper surface of
the pod (as shown in the lower view of the stimulus pod 110). In
some applications it may be advantageous to have the pod connectors
209 on the upper surface of the stimulus pod, because that surface
is away from the patient's skin; in consequence, the connector
contamination is less likely. The stimulus pod 110 can also have
on/off switch 207. A simple push type on/off switch is illustrated,
but many other types of switches are also possible including, for
example, a slide switch, an optical switch, touch sensor, etc. In
use, the on/off switch is typically activated after the contact
with the patient's skin has been established, because the patient's
skin provides a minimum threshold temperature below which the
stimulus pod 110 will not activate, which can also be a safety
mechanism preventing an accidental discharging of the stimulus pod.
In addition to its power on/off function, the on/off switch 207 can
be configured to control a number of heat cycles and/or temperature
of the stimulus pod 110. The stimulus pod 110 can also have a heat
cycle switch 206 to choose heat level like, for example, low,
medium or high. The corresponding indicators 208A-C can light up in
response to a particular heat cycle switch 206 setting. In the
alternative, a single indicator 208 capable of changing its color
can be used to indicate low, medium or high temperature. A push
type heat cycle switch 206 is illustrated in FIG. 5C, but other
types of switch like, for example, slide switch, multi-pole throw
switch, touch sensitive switch, etc. are also possible.
[0043] In several embodiments, the stimulus pods 110 can
communicate with a control station 230, shown schematically in FIG.
5B through any accepted wireless or wired protocol, including radio
frequency (RF), infrared light, laser light, visible light,
acoustic energy, BLUETOOTH, WIFI, or other communication systems.
Additionally, the signals can be sent and received through the
patient's skin. In addition to providing a communication path among
the pods, sending and receiving signals through the patient's skin
may be particularly well suited for determining a distance between
the pods. The control station 230 can be a desktop or laptop
computer, a smartphone, for example an i-Phone, or other device.
The control station 230 can be included with the charging station
200, and in some cases can share components such as a power source,
circuitry, etc. The control station 230 can instruct one or more
stimulus pods 110 to apply heat, electric stimuli, vibration, or
other stimulus or combination of stimulus in various patterns to
the patient's body. In other embodiments the pods 110 include a
button or series of buttons through which the pods 110 can be
manually operated. The possible applications are many, and include
various combinations of ramp up operations, maximum intensity
operations (e.g., maximum temperature or maximum electrical
current, etc.), ramp down operations, stimulus soak operations, and
lockout period operations. The stimulus can be applied from
different stimulus pods 110 at different levels and patterns. For
example, a patient may place a stimulus pod 110 at their upper
back, their lower back, and near each of their shoulders or in a
different arrangement. The control station 230 can vary the
stimulus application at the various zones according to a
predetermined pattern. If a smartphone or other device having a
screen is used as a control station, the screen may display a
graphical representation of patient's body with indication as to
where to locate the pods 110 in a particular application.
Furthermore, the screen may display a countdown time information
for all or some pods 110.
[0044] In several embodiments, the control station 230 can have
information regarding the location of the stimulus pods 110 on the
patient's body, and can vary the stimulus pattern accordingly. In
one embodiment, the stimulus pods 110 can be built with certain
body positions in mind. The stimulus pods 110 can carry body
position labels to instruct the patient to apply the stimulus pods
110 according to the label. For example, in a set of four stimulus
pods, two can be marked "shoulders," a third can be marked "lower
back," and a fourth can be marked "upper back." In some
embodiments, the anchors can communicate its location to the
stimulus pod 110. The anchor 120 can include a passive identifier
such as an RFID tag or other simple, passive method of
communicating with the stimulus pod 110. In this embodiment, the
anchor 120 can remain in place even when different stimulus pods
110 are swapped in and out of the anchor 120. The stationary anchor
120 can accurately provide location information to the control
station 230 independent of which specific stimulus pod 110 occupies
the anchor 120.
[0045] In other embodiments, the patient can inform the control
station 230 where the stimulus pods 110 are situated, and with this
information the control station 230 can apply the desired stimulus
pattern to the stimulus pods 110. For example, the stimulus pods
110 can fire sequentially, and the patient can indicate the
location of the stimulus on a user interface. Through the user
interface, the patient can also operate the system 100 and apply
treatment. In one embodiment, a control station 230 that comprises
a smart phone or a computer, a graphic depiction of the patient's
body can be shown and the patient can indicate to the control
station 230 where the stimulus pods 110 are located. Alternatively,
the patient can directly control the stimulus application through
the stimulus pods 110 by moving a pointing device along the
graphical depiction of their body to create a virtual
stimulus-massage that the patient, or a healthcare professional,
controls directly. In some cases the control station 230 can
include a touch screen that the patient can touch to apply heat or
other stimulus to various portions of their body (or to the body of
another patient).
[0046] FIG. 6 depicts further embodiments of a stimulus delivery
system 100 according to the present disclosure. In some
embodiments, the stimulus delivery system 100 includes a control
station 230, at least one index pod 110a, and several dummy pods
110b. The relationship between the index pod 110a and the dummy
pods 110b can be similar to a master/drone relationship. The index
pod 110a can include more sophisticated telemetry equipment than
the dummy pods 110b, and can act as an intermediary between the
dummy pods 110b and the control station 230. The index pod 110a may
include stimulus components, such as a heating surface or vibration
equipment, and can deliver stimulus just like a dummy pod 110b.
Alternately, the index pod 110a can be a dedicated index pod 110a
with communication equipment, but without stimulus equipment.
[0047] In some embodiments, the index pod 110a and control station
230 can discern when two or more stimulus pods 110 (e.g., dummy
pods 110b or index pods 110a) are near enough to one another that
they can work in aggregate. If the control station 230 knows where
the stimulus pods 110 are placed on the patient's body, the control
station 230, through the index pods 110a, can vary the threshold
distance between stimulus pods 110a, 110b as a function of nerve
density at different locations on the body. For example, if the
control station 230 discerns that two or more dummy and/or index
pods 110a, 110b are three inches apart and on the lower back, the
control station can operate the stimulus pods 110a, 110b together
to effectively cover the area between the stimulus pods 110a, 110b
as well as the area directly contacting the stimulus pods 110a,
110b. By comparison, if stimulus pods 110a, 110b are three inches
apart, but are placed on a more sensitive area, such as the
patient's face or neck, the control station 230 can determine that
the aggregate effect may not be perceived to reach the area between
the stimulus pods 110a, 110b because of the greater nerve density.
This information can be used when applying a treatment plan that
calls for stimulus on a prescribed area. The control station can
determine whether there is a stimulus pod 110 on or near the
prescribed area, and if not, whether the aggregate effect from two
or more stimulus pods 110 can be used to carry out the treatment
plan, and can execute the plan through the pods 110.
[0048] Several clinical studies were performed to evaluate
effectiveness of the stimulus pod system. Details of the clinical
studies and the results are provided below. FIGS. 7A-D show the
results of a study that was designed to understand how to optimize
heat levels, intermittency and heat distribution to produce more
effective analgesia (pain relief). FIGS. 8A-C show comparison
results between a ThermaCare heater and the stimulus pod system as
in this invention treating the pre-menstrual syndrom. FIGS. 9A-C
show comparison results between the ThermaCare heater and the
stimulus pod system as in this invention when treating lower back
pain.
[0049] Study of Characteristics of Thermal Analgesia in Human
Subjects
[0050] A stimulus pod system for the clinical study was designed
and built to optimize heat levels, intermittency and distribution.
The stimulus pod system included a software controller, a set of
instructions on a laptop computer and a hardware interface that
connected a variety of stimulus pods to the laptop controller. A
person skilled in the art would know that many types of controllers
and interfaces could be used for the modular stimulus applicator
system including, for example, off-shelf dedicated controllers and
a software based controller on a smart phone or a tablet computer
connected through a wireless or wired interfaces to the stimulus
pod system. The software controller was used to control thermal
variables. These variables include:
[0051] maximum temperature (.degree. C.) of the high heat cycle
(T-max);
[0052] rate of temperature climb (.DELTA..degree. C./seconds) for
the initial heat cycle (T1-Ramp-up);
[0053] duration of T-max (seconds) (T-max time);
[0054] rate of temperature reduction (.DELTA..degree. C./seconds)
to the baseline soak temperature (Ramp-down). There was no active
cooling, so the Ramp-down time was a passive variable;
[0055] minimum temperature (.degree. C.) of the low heat cycle
(T-soak);
[0056] duration of T-soak (seconds) (T-soak time);
[0057] rate of temperature climb (.DELTA..degree. C./seconds) for
the subsequent heat cycle (T2-Ramp-up);
[0058] wave forms of both the high heat (T-max) and low heat
(T-soak) cycles (a square wave form or a saw tooth pattern). The
temperature difference between the peak and valley of the saw tooth
heat waves was controllable;
[0059] time (in seconds) from the beginning of one ramp up period
to the beginning of the next ramp up period (Heat cycle); and
[0060] time (in minutes) of a number of sequential heat cycles
(demand cycle).
[0061] The control laptop was connected via a USB port to a heating
interface unit. This interface allowed controlling one to four
stimulus pods. The pods had electrical resistance pads with
embedded thermistors, which allowed for very tight control of
temperature. The study initially utilized three sizes of stimulus
pods: small (0.5.times.0.5 inches), medium (1.times.1 inches) and
large (1.5.times.1.5 inches). The stimulus pods were connected to
the heating interface unit with 8 ft long cables that allowed test
subjects to move about the testing station.
[0062] The protocol was initially tested on 10 in-house subjects.
Afterwards, a total of 23 outside subjects completed the entire
initial protocol which was done in one 90 minute session. The
results of the in-house testing were similar to the formal trial
results. Within the group of 23 test subjects, 14 were females
(61%) and 9 males (39%) with a mean age of 31 years (range 17-59,
standard deviation.+-.9.9 years). The subjects were given
explanation about the study procedure and study device. In an
initial subset of subjects, each subject tried three different
sizes of stimulus pods (small, medium, large) to determine what
size was preferred for the subsequent phases of the study. The
midsize stimulus pod was strongly preferred, and was used for the
subsequent studies. In some instances, the subjects could not
determine if the smallest pad was even heating. Also, there was no
preference among the subjects for heating a larger area of the body
by using a larger size (1.5.times.1.5 inches) stimulus pods.
[0063] Furthermore, a study was done to determine whether the
subjects preferred a temperature above that which can be produced
by a ThermaCare pad. Clinical observation indicated that many
people who use heat as a therapy prefer temperatures which are in
fact hot enough to cause hypertrophic changes of the underlying
skin. These temperatures are most commonly obtained using
electrical heating pads. Commercially available chemical heating
pads, e.g., ThermaCare, can provide temperature only up to
40.degree. C. The subsequent clinical observations indicated that
this temperature limited the therapeutic effectiveness of chemical
heating pads.
[0064] Once a subject's preferred temperature profile was
determined, the subject was fitted with a variety of stimulus pods,
and locations and the preferences were recorded. It was observed
that the subjects were able to detect a difference in heat pulses
of less than 1.degree. C. As explained in more detail below, the
subjects preferred a temperature that was significantly warmer
(44.7.degree. C.) than the 40.degree. C. provided by
ThermaCare.
[0065] The initial testing was done to determine the preferred
temperature of the stimulus pods. The heating started at 41.degree.
C. for two minutes duration and then gradually increased in the
0.5.degree. C. increments up to either a maximum temperature of
50.degree. C. or until the subject felt that the pads were too hot.
The initial ramp-up (T1-Ramp-up) was also varied and evaluated for
the subject preference. FIG. 7A shows that the preferred heating
pad temperature was 44.6.degree. C. (range 42-48.degree. C.,
standard deviation.+-.1.4.degree. C.). Only a few subjects
preferred a temperature greater than 46 degrees. Furthermore, as
shown in FIG. 7B, subjects indicated that the perceived comfort of
the heating pads gradually increased with the temperature up to
approximately 45.5.degree. C. Thereafter, the perceived comfort
declined for most subjects. The comfort level can range from 3,
which signifies "very comfortable," to -3, which signifies "very
uncomfortable." The vertical bars on the plot symbols indicate
confidence interval in all graphs.
[0066] The temperature preferences and ratings were quantified
using a thermal sensation scale that progressed from "very cold,"
"cold," "slightly cool," "neutral," "slightly warm," "warm," "hot,"
to "very hot." As shown in FIG. 7C, the subjects indicated that the
pads felt increasingly warmer up to about 47.degree. C. In the
graph of FIG. 7C, the thermal sensation is scales from 0
(temperature neutral) to 6 (very hot). For the temperature above
about 46.degree. C., the temperature was rated as a "hot" or "very
hot." As shown in FIG. 7D, the subjects indicated a gradual
increase in "liking" of the temperature until about 46.degree. C.
The "liking" was on the scale of 0 (terrible) to 10 (wonderful).
The temperature range from about 44.degree. C. to about 46.degree.
C. was the closest to "wonderful." Outside of the 44.degree. C. to
46.degree. C. range, the temperature "liking" was falling away from
"wonderful."
[0067] It was also observed that some subjects liked an additional
pod placed on their body distant to the area that was painful. This
is likely just a distraction effect, but it still increased the
effectiveness of the heating pod that was placed over the body part
in pain.
[0068] In summary, this study systematically evaluated properties
of heat that are likely to relate to thermal analgesia. The
subjects preferred temperatures that were significantly hotter than
the 40.degree. C., which can be provided by chemical heat packs
such as, for example, ThermaCare. The actual or optimal temperature
preferred by the subjects varied and approached a bell shaped
distribution. Initially, it was assumed that the small size heating
pods (0.5.times.0.5 inches) or the large size heating pods
(1.5.times.1.5 inches) would be preferred by subjects. However, the
medium size pads were the most preferred. It is possible that the
small pads were too small to optimally stimulate the cutaneous
thermal receptive fields. In many instances when subjects were
asked how large of an area was being stimulated both the medium and
large pods produced a heated area that was similar in size. In most
instances once the pods were removed, subjects continued to report
that the skin still felt as if it was being heated. Furthermore, in
several subjects with a painful area of the body not being heated
e.g., neck, reported that this proximal unheated area "felt better"
when a distant area e.g., low back was heated.
[0069] The above clinical study demonstrated a "dose response" in
the subjects. There is also a distinct fall-off as temperatures
increase above 45-46.degree. C. The distribution is relatively
tight, and it provides little margin for error with analgesic
devices, such as chemical hot packs with poorly controlled or too
low temperature. Furthermore, it is possible that heat pulses may
provide more stimulation of the cutaneous receptors in comparison
to a steady heat wave.
[0070] Study of Heat Treatment of Premenstrual Syndrome (PMS)
Pain
[0071] FIGS. 8A-C illustrate the results of clinical studies of the
stimulus pod system as applied for the treatment of PMS and
dysmenorrhea (menstrual cramps felt during menstrual periods). PMS
affects a large percentage of women--more than 50 percent of all
women who have a menstrual period. About 20% to 40% of women
experience symptoms that make life difficult. Approximately 5 to 15
percent of these women have severe pain that interferes with daily
activities. Additionally, 2.5% to 5% experience PMS that is
debilitating. Heat is a well recognized self treatment technique
used to help relieve the cramps and the pains (back, abdominal and
pelvic) associated with PMS. In spite of both empiric evidence and
formal studies little is known about mechanisms or heat doses that
are effective for PMS relief. Recent studies demonstrate that low
level heat can significantly reduce PMS pain, and can even reduce
the amount of pain medications used to treat PMS.
[0072] The hypothesis of this study was that a high level pulsed
heat would be more effective than a low level continuous heat in
relieving pain associated with PMS. The study compared analgesic
effects of the stimulus pod system as in this invention with those
of a commercially available ThermaCare.RTM. wrap. The stimulus pod
system consisted of two heating pads that can be set to a
temperature selected by the individual subject. The temperature
range of the heater could be set between and including 42 to
47.degree. C. The ThermaCare wrap is a commercial product available
over the counter. The ThermaCare wrap is attached to the skin using
its own elastic wrap. ThermaCare heats at a steady 40.degree.
C.
[0073] All subjects met with a research assistant (RA) prior to the
start of the study. The RA explained and demonstrated the heating
devices operation, their purpose and the methods of the study. The
subjects were randomly assigned to one of two groups: the stimulus
pod system or the ThermaCare group. All subjects completed a brief
questionnaire about their pain. The study flow is illustrated in
FIG. 8A.
[0074] Subjects rated their PMS pain level using Numeric Pain Scale
and Iowa Pain Thermometer. Those subjects who were initially
assigned to the ThermaCare had the device placed over their area of
greatest pain (anterior abdomen or lower back). ThermaCare devices
were allowed to warm up at least 30 minutes before being placed on
the subject. Subjects rated their pain levels at baseline (time
zero) and after 10, 20 and 30 minutes. After the first treatment
session there was a 30 minute washout period.
[0075] Those subjects who were assigned to the stimulus pod system
group were shown the study device. The RA facilitated a run-in
period in which the subjects were able to gradually increase the
temperature of the heating pads starting at 42.degree. C. up to a
maximum of 47.degree. C. Once the subjects selected study
temperature, the subjects wore the stimulus pod system and provided
pain assessments at baseline and after 10 minutes, 20 minutes and
30 minutes. After completing the study subjects filled out an exit
interview questionnaire and were paid for their participation.
[0076] FIG. 8B shows the results of the Iowa Pain Thermometer
measurements for the stimulus pod system and ThermaCare. The
results indicate significantly greater decrease in Iowa Pain
Thermometer scores from baseline to 30 minutes when participants
used the stimulus pod system device in comparison with ThermaCare
use. Similar differences were found from the baseline to 10
minutes, and from the 20 to 30 minute assessment. No significant
differences were found in the reduction of Iowa Pain Thermometer
scores in the 10 to 20 minutes assessment.
[0077] FIG. 8C shows the results of the Numeric Rating Scale. The
reduction in NRC from baseline to 30 minutes was greater when using
the stimulus pod system. The subjects that used the stimulus pod
system device also reported greater reduction of pain on the
Numeric Rating Scale from baseline to 10 minutes, and from 20 to 30
minutes. Similarly to the Iowa Pain Thermometer scores, no
significant differences were found for the two devices in the pain
reductino from 10 to 20 minutes.
[0078] In conclusion, both treatments produced significant
reduction in pain in the subjects suffering from PMS pain. When
compared to ThermaCare, the stimulus pod system produced
significantly higher pain relief. In the exit interviews, the
subjects almost unanimously noted that they all preferred the
warmer temperatures from the stimulus pod system than those offered
by the low level heat of the ThermaCare product. Many subjects also
explained that they very much liked the pulsing sensation provided
by the Heater device.
[0079] Study of Heat Treatment of Low Back Pain (LBP)
[0080] FIGS. 9A-C illustrate the results of the lower back pain
study. One third of all Americans suffer from back pain at some
point during a given year. The estimated number of individuals in
the United States that suffer from chronic pain varies from 160
million on down, but is generally cited as being close to 50
million. The lower back pain costs employers more than $60 billion
a year in lost productivity. If the cost of treatment is added to
that number, then the cost is estimated at about $100 billion a
year. Men and women are equally affected by the back pain. The pain
occurs most often to people between ages 30 and 50, due in part to
the aging process, but also as a result of sedentary life styles
with too little (sometimes punctuated by too much) exercise. The
risk of experiencing low back pain from disc disease or spinal
degeneration also increases with age. Back pain is the second most
common neurological ailment in the United States--only headache is
more common.
[0081] Heat has long been a mainstay treatment for low back pain. A
number of recent studies demonstrated that heat reduces low back
pain, improves function and may result in the use of fewer pain
medications. In spite of both empiric evidence and formal studies
little is known about mechanisms or dose response data for heat
induced LBP relief. The hypothesis of this study was that a high
level pulsed heat would be more effective than a low level
continuous heat in relieving chronic low back pain.
[0082] The subjects used the stimulus pod system or ThermaCare as
explained above in relation to the Study of Heat Treatment of
Premenstrual Syndrome Pain. Those subjects who were randomized
initially to the stimulus pod system group were shown the study
device. The RA facilitated a run in period in which the subject was
able to gradually increase the temperature of the heating pads
starting at 42.degree. C. up to a maximum of 47.degree. C. Once the
study temperature was selected, subjects wore the device and
provided pain assessments at baseline and after 10 minutes, 20
minutes, and 30 minutes. After completing the study, all subjects
filled out an exit interview questionnaire and were paid $100 for
study participation.
[0083] As shown in FIG. 9A, subjects indicated significantly
greater decrease in Iowa Pain Thermometer scores from the baseline
to 30 minutes when the stimulus pod system was used. Similar
conclusion applies to the time from the baseline to 10 minutes, and
from the 20 to 30 minute assessment. No significant differences
were found between the devices in reduction of the IPT scores from
10 to 20 minutes.
[0084] FIG. 9B shows that the reduction of pain rating on the
Numeric Rating Scale from baseline to 30 minutes was also greater
when using the stimulus pod system device. Similar to the Iowa Pain
Thermometer scores, the subjects using the stimulus pod system also
reported greater reduction of pain on the Numeric Rating Scale from
baseline to 10 minutes, and from 20 to 30 minutes. No significant
differences in the reduction of pain were found from 10 to 20
minutes.
[0085] In conclusion, both treatments (the stimulus pod system and
ThermaCare) produced reduction in pain in the subjects who suffered
from chronic low back pain. The stimulus pod system produced
significantly higher pain relief in comparison to ThermaCare. The
higher heat provided by the stimulus pod system was associated with
better and more profound pain relief. In the exit interviews,
subjects almost unanimously noted that they all preferred the
warmer temperatures from the stimulus pod system than that offered
by the low level heat of the ThermaCare product. Many subjects also
stated that they very much liked the pulsing sensation provided by
the Heater device.
[0086] From the foregoing, it will be appreciated that specific
embodiments of the invention have been described herein for
purposes of illustration, but that various modifications may be
made without deviating from the spirit and scope of the various
embodiments of the invention. Further, while various advantages
associated with certain embodiments of the invention have been
described above in the context of those embodiments, other
embodiments may also exhibit such advantages, and not all
embodiments need necessarily exhibit such advantages to fall within
the scope of the invention. Accordingly, the invention is not
limited, except as by the appended claims.
* * * * *