Register or Login To Download This Patent As A PDF
|United States Patent Application
Anderson; Gregory S.
;   et al.
January 20, 2011
PIEZOELECTRIC, MICRO-EXERCISE APPARATUS AND METHOD
An apparatus and method for micro-exercise apply piezoelectric stress to
cells of a bone mass by inducing voltages in the bone mass. Application
of dynamic, electromagnetic fields passing through the conductive bone
mass induce currents and voltages locally in and around cells or groups
of cells. The cells respond to the combination of mechanical stress and
strain by building themselves up as they would if they had been subjected
to the stress and strain of conventional exercise. Thus, micro-exercise
at a cellular level of the bone mass can be stimulated as if the stress
and strain had been applied to the entire bone structure of which the
smaller cellular portions are constituent parts. In combination with
casts or splints, the sources of electromagnetic flux may be embedded in
the frame or solid structure, the protective padding added for comfort,
Anderson; Gregory S.; (Sandy, UT)
; Huntsman; Kade E.; (Holladay, UT)
; Gledhill; Dale C.; (Sandy, UT)
; Burrell; Douglas R.; (Springville, UT)
; Xiao; David; (Hangzhou, CN)
PATE PIERCE & BAIRD
175 SOUTH MAIN STREET, SUITE 1250
SALT LAKE CITY
July 14, 2009|
|Current U.S. Class:
||602/2; 600/14 |
|Class at Publication:
||602/2; 600/14 |
||A61N 2/04 20060101 A61N002/04; A61F 5/00 20060101 A61F005/00|
1. A method for micro-exercise of bone mass, the method
comprising:providing a frame substantially rigid and defining a first
space sized to receive a bodily member of a human;providing a plurality
of coils spaced apart, embedded in the frame, and effective to pass
electromagnetic flux into the first space;providing a controller fixed to
the frame and delivering power to the plurality of coils providing
mechanical support to a battery by connecting the battery to the frame in
rigid relation thereto;connecting the battery electrically to the
controller to provide power to the controller;immobilizing the bodily
member of a subject within the first space, the bodily member containing
a broken bone integral thereto;programming the controller to provide
power to the plurality of coils in a first sequence;controlling, by the
controller, delivery of power to energize the plurality of
coils;delivering to each coil of the plurality of coils power in
accordance with the programming of the controller; anddelivering, by the
each coil, an electromagnetic flux into the first space proximate the
each coil in accordance with the first sequence; andexercising cells of
the broken bone within the broken bone, in response to the
electromagnetic flux while maintaining the broken bone immobile with
respect to the first space.
2. The method of claim 1, wherein the frame is at least a portion of at
least one of a splint and a cast.
3. The method of claim 2, wherein the cast comprises fasteners rendering
the cast selectively removable and re-installable.
4. The method of claim 2, wherein the cast is a boot cast.
5. The method of claim 4, wherein the boot cast further comprises a
6. The method of claim 5, wherein the walking pad further comprises a
witness element detecting walking.
7. The method of claim 6, wherein the witness element is selected from a
destructively modified surface responding to at least one of weighting
and wear, a load detector, and a motion detector.
8. The method of claim 7, wherein the witness element is a pedometer.
9. The method of claim 1, further comprising executing a first cycling of
the power delivered to the each coil at a first frequency substantially
continually during an active portion of a first time period.
10. The method of claim 9, wherein the first frequency is from about 50 to
about 500 Hertz.
11. The method of claim 10, wherein the first frequency is selected to be
from about 100 to about 300 Hertz.
12. The method of claim 11, wherein the frequency is selected to be from
about 150 to about 200 Hertz.
13. The method of claim 9, further comprising executing a first halting of
the first cycling for an inactive portion of the first time period.
14. The method of claim 13, further comprising a first repeating of the
first cycling and first halting of the first time period throughout a
first plurality of time periods, the first plurality of time periods
constituting an active portion of the second time period.
15. The method of claim 14, further comprising a second halting of the
first repeating for an inactive portion of the second time period.
16. The method of claim 15, further comprising operating the controller to
energize the plurality of coils for a total time of the first activated
portions of the first cycling for a duty cycle, wherein the duty cycle is
the sum of all the active portions of the first cycling occurring during
the second time period, divided by the second time period.
17. The method of claim 16, wherein the duty cycle is from about 0.003 to
18. The method of claim 1, further comprising:separating the coils of the
plurality of coils into regions, each region comprising a corresponding,
unique, and proper subset of less than all the coils of the plurality of
coils; andreducing interference between magnetic fields created by each
coil of the plurality of coils by the first sequencing energizing all
coils corresponding to each region substantially simultaneously by region
and exclusive of all other regions.
19. A method for micro-exercise of bone mass, the method
comprising:providing a frame, selected from a splint and a selectively
removable and replaceable cast, the frame being substantially rigid,
defining a first space sized to receive a bodily member of a human, and
having fasteners rendering the frame selectively removable and
re-installable;providing a plurality of coils spaced apart, embedded in
the frame, and effective to pass electromagnetic flux into the first
space;providing a controller fixed to the frame and delivering power to
the plurality of coils providing mechanical support to a battery by
connecting the battery to the frame in rigid relation thereto;connecting
the battery electrically to the controller to provide power to the
controller;immobilizing the bodily member of a subject within the first
space, the bodily member containing a broken bone integral
thereto;programming the controller to provide power to the plurality of
coils in a first sequence;controlling, by the controller, delivery of
power to energize the plurality of coils;delivering to each coil of the
plurality of coils power in accordance with the programming of the
controller; anddelivering, by the each coil, an electromagnetic flux into
the first space proximate the each coil in accordance with the first
sequence; andexercising cells of the broken bone within the broken bone,
in response to the electromagnetic flux while maintaining the broken bone
immobile with respect to the first space;the frame further formed to
resemble the envelope of a boot, and comprising a witness element
selected from a destructively modified surface responding to at least one
of weighting and wear, a load detector, and a motion detector;connecting
the coils of the plurality of coils into regions, each region comprising
a corresponding, unique, and proper subset of less than all the coils of
the plurality of coils;reducing interference between magnetic fields
created by each coil of the plurality of coils by the first sequencing
energizing all coils corresponding to each region substantially
simultaneously by region and exclusive of all other regions;executing a
first cycling of the power delivered to the each region at a first
frequency substantially continually during an active portion of a first
time period;executing a first halting of the first cycling for an
inactive portion of the first time period;executing a first repeating of
the first cycling and first halting of the first time period throughout a
first plurality of time periods, the first plurality of time periods
constituting an active portion of a second time period;executing a second
halting of the first repeating for an inactive portion of the second time
period; andoperating the controller to energize coils of the plurality of
coils for a duty cycle of from about 0.003 to about 0.1, wherein the duty
cycle is the sum of all the active portions of the first cycling
occurring during the second time period, divided by the second time
20. An apparatus micro-exercising a broken bone, the apparatus
comprising:a frame substantially rigid and defining a first space sized
to receive a bodily member of a human;a plurality of coils spaced apart,
embedded in the frame, and effective to pass electromagnetic flux into
the first space;a controller fixed to the frame and delivering power to
the plurality of coils;a battery;mechanical supports connecting the
battery to the frame in rigid relation thereto;the battery electrically
connected to the controller to provide power to the controller;the frame
further comprising securement members immobilizing a bodily member of a
subject within the first space, the bodily member containing a broken
bone integral thereto;the controller further programmed to provide power
to the plurality of coils in a first sequence to energize the plurality
of coils;the controller, further delivering to each coil of the plurality
of coils power in accordance with the programming;the each coil further
delivering an electromagnetic flux into the first space proximate the
each coil in accordance with the first sequence; andthe controller,
further programmed and operable to exercise cells of the broken bone
within the broken bone, in response to the electromagnetic flux, while
the frame maintains the broken bone immobile with respect to the first
1. The Field of the Invention
This invention relates generally to reduction in bone mass
associated with inactivity, such as occurs whenever a limb is immobilized
by a cast for an extended period of time, and more particularly to
apparatus and methods to promote exercise on a cellular level when actual
exercise motion by the limb is not available.
2. The Background Art
Bones represent a curious structure, often referred to in the prior
art as "not well understood." In space, such as during missions to the
moon, extended orbits, work within the space station, during healing of a
broken bone immobilized in a cast for typically six weeks or more, and
the like, science has studied the loss of bone mass. The lack of exercise
appears to relate to the loss of bone mass.
Moreover, bone mass may be lost at a greater rate in the absence of
exercise then it can typically be regained upon resumption of exercise.
Thus, what is needed is an apparatus and method to apply exercise to a
bone structure that is immobilized as a result of casting, traction,
immobilization, or the like.
BRIEF SUMMARY OF THE INVENTION
An apparatus and method in accordance with the invention may include
a frame forming a basic structure of a device such as a removable cast or
splint. The frame may or may not include a wrap. Typically, a wrap may be
provided for warmth, comfort through isolation of the frame from the
injured member, or the like. The frame, the wrap, or both may include
embedded electromagnetic coils. The electromagnetic coils may be
programmatically controlled to energize with a timing and sequence
selected to render treatment effective and to minimize cancellation of
electromagnetic fields created by the coils.
The embedded coils may operate to set up dynamic electromagnetic
fields. Dynamic electromagnetic fields create electrical currents as a
result of passing through conductors or around conductors. Various
equations of physics define the electromagnetic activities of a magnetic
flux as it rises and falls in density with respect to time. For example,
motors of the electrical type operate on the responses of moving parts to
the changing of electromagnetic fields within them. Meanwhile, those
electromagnetic fields are set up by electrical currents operating in
coils within those motors.
By the same token, moving an electromagnetic fields with respect to
conductors or moving conductors through electromagnetic fields induces
currents in conductors.
Accordingly, in certain embodiments of apparatus and methods in
accordance with the invention, electromagnetic fields as they rise and
fall in intensity in a localized area may induce currents within bone
materials. Bone material is piezoelectric. Capitalizing on the
piezoelectric nature of the structural material of bone, an apparatus and
method in accordance with the invention may induce voltages across
portions of bone material as a result of the rising and falling of
electromagnetic force applied dynamically. That is, as the flux density
of the electromagnetic coils rises and falls, it creates electrical
currents and voltages in conductive materials nearby.
In certain embodiments of an apparatus and method in accordance with
the invention, the induced voltages and currents operate on the
piezoelectric cellular structures of bone matter to stress the bone.
Literally, the bone material distorts with the presence of the applied
voltage. Thus, at a very low level, bone material may be stressed and
strained, that is, loaded with force or pressure and stretched or
compressed accordingly, with the application of electrical voltage.
When bones are exercised, just as muscles are exercised, the forces
or loads applied thereto stretch or compress the affected tissue. The
contraction of muscles is well appreciated. Likewise, muscles may extend
or contract as they operate to move bone structures within the body. It
is not as well understood that any time the supposedly "fixed" length of
a bone is put under load, that bone stretches, compresses, bends, or a
combination thereof in some slight amount compared to the much greater
amount of such deflection or distortion by a muscle.
The need to exercise muscles is well understood. However, the need
to exercise bones is less well understood, and perhaps not understood by
many who readily accept the need for muscle exercise. Thus, one may think
of conventional exercise as including a process of stressing the bones in
a way that causes them to stretch, compress, bend, or a combination
thereof. Bones appear to respond to exercise by building mass. When bones
are immobilized, an apparatus and method in accordance with the invention
may still create at a cellular or microscopic level the conditions that
exercise would have created. A lack of exercise corresponds to a lack of
piezoelectric activity in the bone.
As bones distort, they behave piezoelectrically. Just as an
electrical voltage applied to a piece of bone causes a distortion in that
piece of bone, imperceptible to the eye, but perceptible by various
measurement techniques, the reverse process also works. For example, if a
voltage applied to a piezoelectric material distorts the piezoelectric
material, then distortion of the piezoelectric material will create a
voltage across it.
For example, if walking about on the earth creates healthy bones,
and if exercise tends to build bone mass, while a lack of exercise tends
to lose bone mass, an individual cell may be seen as a tiny embedded
element within that bone structure. As far as that cell is concerned, it
does not know about the foot running on the ground, or the arm lifting
weights. Rather, that small cell of bone only responds to the stress and
strain it undergoes.
In response to that stress and strain, and the piezoelectric signals
of electricity generated as a result of the stress and strain on that
cell of bone, the bone responds. The bone responds to exercise by
developing bone mass. Therefore, the bone mass decreases when a bone is
cast for healing, such as a broken arm or broken leg. Likewise, in space,
where bones are not required to maintain the support structure of the
body mass of an individual against gravity, they do not see the common,
daily, continual stress and strain of simply living.
Thus, loss of bone mass may be attributed in large part to a lack of
exercise. This appears to also be corroborated by the correlations
between osteoporosis and exercise. As people become immobile, they tend
to increase the porosity of bone and decrease its mass.
Accordingly, an apparatus in accordance with the invention provides
piezoelectric, micro-exercise for bone structures replicating the
conditions that would typically exist if that bone mass were able to be
In certain apparatus, the frame and the covering pad may both
include magnetic coils. Energizing the coils in the frame, in the pad, or
both may occur alone, separately, or in a coordinated fashion.
Meanwhile, a controller may control the energizing of
electromagnetic coils in the pad, in the frame, or both. The controller
may be programed by a physician to input a particular piezoelectric
exercise regimen proposed. In certain embodiments, an individual may be
able to program a controller controlling the energizing of coils in the
padding or frame according to how the user is feeling.
Coils may be installed in various locations and selectively
activated according to a desired effect. For example, in certain
embodiments, the coils may be placed in the bed of a sole of a boot cast.
Likewise, coils may be placed along the vertical uprights in the cast.
Coils may be placed in other strategic locations according to the desired
process and effect implemented.
In certain embodiments, coils may be sequenced in a series of
overlapping rising and magnetic fields in a particular area. In other
embodiments, coils may be sequenced in a manner that provides that the
magnetic field from one coil may be completely collapsed before the
magnetic field on the other arises. Thus, interaction between coils may
For example, in a transformer, a "bucking" arrangement may be set up
in which two transformers are basically transforming against one another.
The result is a generation of heat, expenditure of energy, but no net
energy is really transferred across systems. Thus, in certain
embodiments, the programmatic controls of the controller may assure that
within a reasonable proximity of one another, various coils are not
energized and de-energized at a rate and proximity that will negate the
influence of one coil by another. This makes energy conservation sense as
well as therapeutic sense in that the magnetic field is permitted to
penetrate as far as possible and act alone or in concert, rather than
against other magnetic fields set up by other coils.
In other methods and apparatus in accordance with the invention,
coils may be designed to have various diameters, numbers of turns, air
cores, or electromagnetic cores according to the desire for direction and
intensity of magnetic field. For example, that flux density in a magnetic
core may provide much better alignment and penetration.
It has also been suggested that bone response to electromagnetic
stimulation is ineffectual after about thirty minutes of treatment. This
is consistent with other experiments and experiences with nutrition. The
body must deliver energy, and depends on the catalytic minerals in the
cells to provide the energy release required to support cell activity.
Meanwhile, the body relies on various chemical transport processes
to carry away waste by-products, the chemical reactants resulting from
energy generation by cells. Those reactants are often rich in reactive
materials or "free radicals." Anti-oxidants neutralize free radicals and
prevent them from causing other chemical damage to cells as they are
transported through the cells and away to the body's waste handling
systems. Thus, minerals catalyze the chemical breakdown of energy
materials, while anti-oxidants neutralize the by-products of energy
released in the cells.
Similarly, whenever any process overruns or outruns other bodily
processes, the overall system cannot operate any faster than its slowest
intermediate process. In any chemical reaction, it is typical that
several chemical reactions are actually taking place. The overall system
of chemical reactions can proceed no faster than the rate-limiting
reaction that every other reaction is waiting on.
Thus, in apparatus and method in accordance with the invention,
rather than apply therapy in every case a single time everyday, shorter
periods of therapy may be applied at intervals extended throughout the
day. Thus, the other bodily processes can keep up with the bone
stimulation in order to provide a balanced building process.
In certain embodiments, a duty cycle for an apparatus in accordance
with the invention may involve the system being on for one minute and off
for 59. In other embodiments, the apparatus may be on for 10 minutes and
off for 50 minutes every hour. Meanwhile, the individual coils in the
apparatus may be on for only a very small fraction of the duty cycle,
inasmuch as the coils are activated in sequence.
In certain embodiments, the prescribed system of electromagnetic
activity from the coils of the frame, covering, or both, may be tracked
and correlated with x-rays in order to show the response of a particular
area of bone mass to an apparatus and method in accordance with the
invention. Thus, the use of periodic x-rays in assessing the bone density
of an immobilized limb may be used to alter the regimen prescribed, and
may be used to complete the regimen in body one location, while
continuing it in another in order to provide a uniform development of
In certain embodiments, an integrated dressing may be used having
electromagnetic coils operated by the system in accordance with the
invention. Thus, a dressing, a frame, a covering or wrap for the member
may each be used individually, or any combination thereof may be used in
order to provide electromagnetic flux densities required and the dynamic
rising and falling thereof in order to provide the bone density
management or intervention required.
In certain embodiments of an apparatus in accordance with the
invention, a wear layer or witness layer may be provided on the foot bed
or sole of a boot cast. For example, removable boot casts provide a foot
bed similar to a shoe. A wear layer may be provided such as a two-layer
lamination having a comparatively easily worn off top layer of one color
with a more robust substrate therebelow. Thus, if an individual walks
prematurely on the boot cast, then the witness layer may show the
contrasting color of the substrate through a ruptured or worn off outer
portion, thus providing an absolute verification that the foot has been
pressuring, wearing, or otherwise active on the foot bed.
In certain embodiments, comparatively flat coils may be embedded in
wraps (coverings), structures of a frame, such as the foot bed, vertical
uprights, collars, straps, and the like in order to provide penetration
normal (perpendicular) to the surfaces about which those portions of the
apparatus lie. Thus, electromagnetic flux may be directed into the bodily
member for which bone density intervention is desired. In other
embodiments, the coils may be aligned in order to provide a flux that
flows parallel to the surface, and thus at a greater distance eventually
curves in to and travels axially along the subject member being treated.
Nevertheless, a particularly effective and lightweight system may be made
very flexible by a large distribution of small coils embedded within a
covering, frame member or the like.
BRIEF DESCRIPTION OF THE DRAWINGS
The foregoing features of the present invention will become more
fully apparent from the following description and appended claims, taken
in conjunction with the accompanying drawings. Understanding that these
drawings depict only typical embodiments of the invention and are,
therefore, not to be considered limiting of its scope, the invention will
be described with additional specificity and detail through use of the
accompanying drawings in which:
FIG. 1 is a perspective view of one embodiment of a boot cast having
a system of vertical uprights with an attached bracket secured to the
uprights and the foot bed of the boot cast in order to support a
controller and power pack;
FIG. 2 is a rear quarter perspective view of an apparatus in
accordance to the embodiment of FIG. 1;
FIG. 3 is a front elevation view of the apparatus of FIGS. 1-2;
FIG. 4 is a right side elevation view of the apparatus of FIG. 1;
FIG. 5 is a left side elevation view of the apparatus of FIG. 1;
FIG. 6 is a rear elevation view of the apparatus of FIG. 1;
FIG. 7 is a top plan view of the apparatus of FIG. 1;
FIG. 8 is a bottom plan view of the apparatus of FIG. 1;
FIG. 9 is a front quarter perspective view of the apparatus of FIG.
FIG. 10 is a front quarter perspective view of an alternative
embodiment of an apparatus in accordance with the invention;
FIG. 11 is a bottom quarter perspective view from a rear quarter of
the apparatus of FIG. 10;
FIG. 12 is a front elevation view of the apparatus of FIG. 10;
FIG. 13 is a right side elevation view of the apparatus of FIG. 10;
FIG. 14 is a rear elevation view of the apparatus of FIG. 10;
FIG. 15 is a left side elevation view of the apparatus of FIG. 10;
FIG. 16 is a top plan view of the apparatus of FIG. 10;
FIG. 17 is a bottom plan view of the apparatus of FIG. 10;
FIG. 18 is a rear upper quarter perspective view of an alternative
embodiment of an apparatus in accordance with the invention;
FIG. 19 is a rear quarter perspective view with the controller
remove from the battery pack portion of the apparatus of FIGS. 10-17;
FIG. 20 is a rear perspective view of the apparatus of FIG. 19;
FIG. 21 is a front perspective exploded view of the apparatus of
FIG. 19, in an upside down configuration in order to show the bottom
plate and battery packs as well as connectors;
FIG. 22 is a side quarter perspective exploded view of the
controller of the apparatus of FIG. 19, as implemented in the apparatus
of FIGS. 10-17;
FIG. 23 is a chart of voltage with respect to time to illustrate a
reduced duty cycle in the electromagnetic coils in accordance with the
FIG. 24 is a schematic diagram of one embodiment of a wrap having a
series of coils sequenced along extent thereof;
FIG. 25 is a table of testing results illustrating an array of
voltages at various frequencies and duty cycles with the effective
magnetic density in micro Teslas and the corresponding currents running
in the various coils;
FIG. 26 is a schematic diagram illustrating the current direction
for the wires of a coil with the corresponding direction of the magnetic
field generated thereby;
FIG. 27 is a schematic diagram illustrating the current direction in
a conductor with the resulting direction of the magnetic field induced
FIG. 28 is a chart illustrating a series of experiments indicating a
series of voltages with the frequency and duty cycle corresponding
thereto in the x, y, and z axis for a particular embodiment of an
apparatus in accordance with the invention;
FIG. 29 is a table of magnetic flux densities for a particular set
of voltages and resulting current amperages for a 150 Hertz cycling of an
apparatus in accordance with the invention operating on a 10 percent duty
FIG. 30 is a table of magnetic flux densities for a particular set
of voltages and resulting current amperages for a 500 Hertz cycling of an
apparatus in accordance with the invention operating on a 5 percent duty
FIG. 31 is a table of magnetic flux densities for a particular set
of voltages and resulting current amperages for a 500 Hertz cycling of an
apparatus in accordance with the invention operating on a 10 percent duty
FIG. 32 is a table of magnetic flux densities for a particular set
of voltages and resulting current amperages for a 200 hertz cycling of an
apparatus in accordance with the invention operating on a 5 percent duty
FIG. 33 is an exploded view of one embodiment of a wrap or pad
material for use in an assembly in accordance with the invention,
illustrating covering layers, enclosing or capturing a layer holding
embedded electromagnets therein;
FIG. 34 is a partial, cutaway, perspective view of one embodiment of
the inner mat from the apparatus of FIG. 33;
FIG. 35A is a perspective, exploded view of one embodiment of an
electromagnet for use in an apparatus in accordance with the invention
such as the mat of FIGS. 33-34;
FIG. 35B is a perspective view of the assembled electromagnetic coil
with optional magnetic core shown for the apparatus of FIG. 35A;
FIG. 36 is a top plan view of one embodiment of a mat, such as the
mat of FIG. 34, embedded within the wrap or covering of the apparatus of
FIG. 37 is an alternative embodiment of the mat of FIGS. 33 and 36
in which the coils may be captured on spools or spindles rather then
embedded within a mat, and the core regions may still be provided with
metallic centers, or may simply rely on air cores;
FIG. 38 is an illustration of an alternative embodiment for
embedding coils within a synthetic material or a natural material by
bonding directly a covering material around the coil, thus capturing the
coil in a sandwich of material, which may be bonded by a separate
adhesive or by a thermal bond, such as between two layers of synthetic
(polymeric) material melted by heat, or the like, and may include
nonwoven fabric as the underlying material, the bonded capturing
material, or both;
FIG. 39 is a perspective view of an alternative embodiment of a wrap
for use in a removable boot cast, and illustrating a plurality of coils
embedded within the wrap;
FIG. 40 is a perspective view of one embodiment of a wrap suitable
for an arm, and adaptable for use in a splint or removable cast frame, or
even included within a cast or the outside of a cast in order to provide
the coils in accordance with the invention;
FIG. 41 is a plan view of the wrap or cover of FIG. 40 unwrapped and
showing the removable hook and loop fastener or other fastener material;
FIG. 42 is a perspective view of one embodiment of a wrap suitable
for a boot cast in accordance with the invention;
FIG. 43 is a plan view of an unwrapped cover or wrap of FIG. 42 as
it may appear before being assembled around a foot;
FIG. 44 is a perspective view of one embodiment of a wrist wrap and
provided with a penetration for a thumb of a user;
FIG. 45 is a plan view of the wrap of FIG. 44 illustrating the
fastener strip and the aperture for a hand;
FIG. 46 is a perspective view of one embodiment of a wrap in
accordance with the invention suitable for use as a neck collar;
FIG. 47 is a perspective view of wrap in accordance with the
invention configured around the outside of a spacing block, such as may
be used for maintaining spacing between injured legs;
FIG. 48 is a plan view of an alternative embodiment of a wrap in
accordance with the invention for wrapping around a member having a
substantially constant cross-section;
FIG. 49 is a plan view of an alternative embodiment of a wrap in
accordance with the invention suitable for wrapping around a tapered
member, such as a lower calf, a wrist, or forearm, or the like in which
the bodily member has a substantial reduction in cross-section from one
end to the other;
FIG. 50 is a perspective view of one embodiment of an alternative
power pack associated with a wrap in accordance with the invention;
FIG. 51 is a plan view of one embodiment of a dressing having
multiple coils provided power through a connector at one end of the
FIG. 52 is an exploded view of a dressing of FIG. 51 illustrating
multiple layers for providing the fundamental dressing needs of a wound
while applying the electromagnetic coils for remediation of the
underlying bone structures, but may be used also to influence the tissue
rebuilding, using power from a battery pack such as that of FIG. 50, or
the illustrated battery in FIG. 52;
FIG. 53 is a schematic block diagram of one embodiment of a system
for providing programmatic control of an apparatus in accordance with the
invention, including both a connector for interfacing with a programming
system such as a computer or the like, as well as connectors, which are
optional, and may be temporary, permanent, or absent for connecting to
the unit to be powered and to a source of power.
FIG. 54 is a perspective view of one embodiment of a controller for
remotely controlling an apparatus in accordance with the invention;
FIG. 55 is a top plan view of the apparatus of FIG. 54;
FIG. 56 is a right side elevation view of the apparatus of FIG. 54;
FIG. 57 is a bottom plan view of the apparatus of FIG. 54;
FIG. 58 is an end elevation view of the apparatus of FIG. 54;
FIG. 59 is an opposite end elevation view of the apparatus of FIG.
54 showing the connection port for connecting to the system of FIG. 53
for programming the controller;
FIG. 60 is a rear elevation view of one embodiment of a removable
boot cast in accordance with the invention and providing a gripping loop
as part of the structure;
FIG. 61 is a cutaway perspective view of one alternative embodiment
of a portion of the frame of a boot cast in accordance with the invention
and illustrating a detector to detect motion or force by a wearer, by
compromising a witness layer on top or bottom of the foot bed or by a
pedometer detecting motion or force; and
FIG. 62 is a bottom plan view of the apparatus of FIG. 61.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
It will be readily understood that the components of the present
invention, as generally described and illustrated in the drawings herein,
could be arranged and designed in a wide variety of different
configurations. Thus, the following more detailed description of the
embodiments of the system and method of the present invention, as
represented in the drawings, is not intended to limit the scope of the
invention, as claimed, but is merely representative of various
embodiments of the invention. The illustrated embodiments of the
invention will be best understood by reference to the drawings, wherein
like parts are designated by like numerals throughout.
Referring to FIG. 1, an apparatus 10, such as a boot cast or the
frame of a boot cast, may include a base 12. In certain embodiments, the
base 12 may be made of plastic or another suitable polymer or reinforced
polymer. For example, when the apparatus 10 is a boot cast, the base 12
or portion thereof may serve as the foot bed on which the foot of a user
will ultimately rest. Likewise, the base 12 also may serve as the
fundamental structure that contacts the ground when the boot cast
apparatus 10 is used in a walking configuration.
In certain circumstances, an individual may be provided with a cast,
splint, or other similar apparatus 10 for immobilizing a bodily member.
At some point, the apparatus 10 may be converted and used to actually
support limited mobility (e.g., be walked upon) as the injured member has
achieved a degree of healing that will permit some partial use.
In certain embodiments, struts 14 or uprights 14 may extend from the
base 12. Typically, the struts 14 may be fixed with respect to the base
12 in order to rigidize the injured member. In certain embodiments, the
struts 14 may be flexibly connected to the base 12.
In certain embodiments, a rack 16 may secure to the struts 14.
Typically, the rack 16 may serve multiple functions. For example, the
rack 16 may serve to support auxiliary equipment for operating the
apparatus 10 in accordance with the invention. Batteries, controllers 22
and the like may be mounted to the rack 16 away from the struts in the
base 12 that are therapeutically operative for rigidizing the bodily
By the same token, the rack 16 may also serve to provide additional
strength, rigidity, or stiffness to the struts 14. Thus, with the
addition of the rack 16, the struts 14 may be downgraded in their
structural stiffness or strength. However, in alternative embodiments,
the struts 14 may be constructed to perform their function entirely
alone, and the rack 16 may be added for a secondary function such as
carrying auxiliary equipment.
Certain embodiments may include a pad 18 (not shown in FIG. 1; refer
to FIGS. 33-48 generally, et. seq.) or wrap 18. The pad 18, or wrap 18 as
it may also be referred to, provides multiple functions. At a basic
physical level, the pad 18 provides stress distribution against prominent
parts of the bodily member and pressure relief against the loading of
skin and muscle by the presence of the base 12 or struts 14, and the
At another level, the pad 18 may operate as a holder, distributor,
and locator for multiple electromagnetic coils in the apparatus 10 in
order to apply electromagnetic flux to various portions of the bodily
member. Thus, instead of, or in addition to, the electromagnetic coils
located in the struts 14 and rack 16, the pad 18 may include
electromagnetic coils developed for electromagnetic portions of therapies
applied to the bones of the immobilized member placed inside the
Referring specifically to FIGS. 1-9, and more generally to FIGS.
1-22, the apparatus 10 may include various sources 20. Typically, the
sources 20 are electromagnetic force coils or coils of conductors
providing electromagnetic fields as a result of electric current passing
through the conductors of the coils. The sources 20 of electromagnetic
flux may be distributed about the base 12 and struts 14 of the frame of
the apparatus 10. Likewise, the sources 20 may be distributed throughout
the pad 18.
In certain embodiments contemplated, a controller 22 operates to
control one or more of the current, the wave form of the current, the
voltage, the time of operation, any combination thereof, and so forth for
the sources 20 distributed in the pad 18, the rack 16 or frame 16 made up
with the base 12 and strut 14 as the structural elements of the apparatus
In general, the base 12 may include a bed 24 or foot bed 24 on which
the foot of a user is supported. The bed 24 may be formed of a solid, of
a porous solid, of a ribbed solid, including ribs 26 stiffening the base
12 and bed 24 while minimizing weight, or the like. Thus, an expanded
polymer, a ribbed polymeric molding, or the like may form a bed 24 having
ribs 26 to add stiffness while minimizing weight a user must lift.
In the illustrated embodiment, a wall 28 may substantially surround
the bed 24, protecting against incursion by dirt, water, debris, and the
Meanwhile, the wall 28 forms an outermost edge, rib, or stiffener,
ultimately providing additional section modulus for the bed 24 and base
12. For example, the wall 28 may extend substantially higher than the
ribs 26, inasmuch as the foot of a user, in the illustrated embodiment,
may fit down between the walls 28, on either side of the base 12.
Padding, a witness layer, or other treatments may be placed on top
of the ribs 26 of the foot bed 24 or bed 24. A witness layer or surface
may be configured to detect pressure, wear, or other time-inappropriate
use by a user. For example, a thin layer of material that is easily
damaged may be placed on top of a more robust layer such as a foam pad or
solid layer of material on the ribs 26. Thus, any pressure, or any
significant wear may be detected by damage to the thin uppermost,
fragile, witness layer, signifying that a user has walked on the
apparatus 10 or otherwise applied weight to the base 12 and bed 24 that
is inappropriate at the particular time according to the prescription of
medical personnel. A witness layer may be on the bottom of the sole 30
instead of or in addition to a witness layer on the foot bed 24.
A base 12 may be provided with a sole 30 for actually accepting the
pressure and wear of use on a walking surface. For example, in a regimen
assigned to a person having a broken leg, an individual may be prohibited
from weighting the bed 24 and base 12 of the apparatus 10 for a period of
weeks. Thereafter, however, the individual may be prescribed certain
weighting of the apparatus 10, such as by a light weight placed thereon
while the user walks on crutches. Ultimately, the individual may be
instructed to place full weight on the foot, and consequently on the ribs
26 and base 12, in order to resume walking and other conventional
exercise. As an individual begins to walk on the base 12, a sole
comparatively softer and more flexible 30 may protect against undue wear
on the more rigid parts of the base 12, while also providing a certain
amount of cushioning against the hard and abrasive materials of a
sidewalk or street.
Referring to FIGS. 1-9, while continuing to refer generally to FIGS.
1-22, the base 12 may be provided with loops 32 or other securement
devices 32 such as rivets, screws, apertures, glue, hook-end-loop
fasteners, or the like in order to secure straps thereto. Loops 32 may
extend vertically up or horizontally out from the top edges of the wall
28. Loops 32 may be hinged or rigid.
Typically, straps passing through the loops 32 on either side or
either wall 28 on the left and right sides of the apparatus 10 may secure
the apparatus 10 to an appendage of a user. Likewise, inasmuch as the
apparatus 10 is typically a removable device 10 in the illustrated
embodiment, straps through the loops 32 may provide securement of the
apparatus 10 to an appendage at a comfortable level of snugness (e.g.,
tension, and thus pressure).
For example, a pad 18 may surround a foot on the bed 24 and
underneath straps passing through the loops 32. Accordingly, a user may
secure the straps through the loops 32 at a tension calculated to provide
a degree of securement, balanced with a degree of comfort in view of the
pad 18 about the foot of a user.
A series of fasteners 34 may secure a rack 16 to the base 12 and
struts 14. Typical fasteners may include screws, bolts, glue, ultrasonic
welding, or the like. Typically, fasteners 34 may be arranged in
sufficient number to provide a substantially rigid connection between the
rack 16 and the struts 14 and base 12. Fasteners 34 may be configured as
a design element.
In alternative embodiments, some degree of flexibility may be
desired. Accordingly, movable or pivotable fasteners 34 may be used as
pivot points. In alternative embodiments, flexible fasteners 34 providing
pivoting may be implemented. However, in one common embodiment, the
fasteners 34 may triangulate and thereby rigidize the rack 16 with
respect to the base 12, the strut 14, and both. Likewise, fasteners 34
may fix the struts 14 with respect to the base 12.
In certain embodiments, the rack 16 may be configured as a bracket
16 for mounting the controller 22. For example, a top portion 36 of the
bracket 16 may be mounted by fasteners 34 to the struts 14. Meanwhile, a
lower portion 38 or bottom portion 38 of the bracket 16 or rack 16 may
secure to the base 12. Meanwhile, a central portion 40 or center portion
40 of the rack 16 or bracket 16 may secure the controller thereto. Thus,
the upper and lower portions 36, 38 may stand off or place away from the
struts 14 the central portion 40 securing the controller 22. Thus, the
controller 22 riding on the central portion 38 may be spaced away a
suitable distance to permit comfortable retention of the bodily member
placed in the apparatus 10.
Wires 42 may connect between the controller 22 and the various
sources 20 of electromagnetic force. Accordingly, wires 42 may be
embedded within the base 12, struts 14, and elsewhere by way of
appropriate paths. The wires 42 may represent a single circuit or many
circuits providing for individual sequencing and control of the various
sources 20 distributed about the apparatus 10 in the struts 14, base 12,
pad 18, and the like.
Referring to FIG. 2, while continuing to refer generally to FIGS.
1-9 and FIGS. 10-22, an apparatus 10 in accordance with the invention may
include a display 44. The display 44 may be responsible for displaying
time, programmatic information for an individual programming the
controller 22, as well as status information, instructional readouts, or
the like for a user.
The controller 22 may be provided with a port 26 suitable for
connecting the controller 22 to a computer, keyboard, or other user
interface device suitable for programming the controller 22 for its
functional regimen. For example, a doctor may prescribe a particular
regimen, which regimen may be programmed by software.
The software may reside in the controller 22 itself, or may reside
in a computer external thereto. By either a user interface or computer, a
programmer, user, doctor, or medical professional may program the
operation of the controller 22 as to time, frequency, power, voltage,
current, or any combination or subcombination thereof in order to control
the sequencing, intensity, frequency, duty cycle, and the like of the
sources 20 controlled by the controller 22. Thus, instructions, data, and
the like may be exchanged between the controller 22 and a remote device
such as a computer by suitable connection through a port 46.
In general, the port 46 may be of any suitable type, including
proprietary or standardized formats. For example, in certain embodiments,
the port 46 may be a standard USB port suitable for connecting one
computer peripheral device to another, or one computer to another.
Accordingly, the port 46 may receive instructions from a remote computer,
a user interface, a keyboard, or any other input device, such as a
keypad, or unique proprietary device suitable for providing instructions,
downloads, or even direct manipulation of the programming of the
In general, the sources 20 may be imbedded in apertures made in the
struts 14, the base 12, or both. In general, the individual sources 20
may be separately powered and controlled, may be controlled in groups,
and individual sources 20 or groups may be controlled in a sequence
otherwise manipulated to assure the sequence in which each is properly
The spacing between the sources 20 (e.g., radially therebetween) may
be selected according to the electromagnetic flux of any particular coil,
the potential for interference, the isolation by sequencing at individual
times, or the like. Accordingly, an apparatus 10 in accordance with the
invention as illustrated may include more or fewer sources, may include
magnetic cores within the sources or air cores, and may include more or
fewer of the coils distributed in a particular member, such as a strut 14
or the base 12.
Referring to FIG. 18, a strut 14 of the apparatus 10 in accordance
the invention may include augmentation of a strut 14 by a panel 48. The
panel 48 may extend the horizontal domain of the strut 14 to provide
additional material and surface area to support sources 20. In the
embodiment of FIG. 18, the strut 14 on one side, or the struts 14 on both
sides, of the apparatus 10 may be provided with one or more panels 48
containing sources 20. In the illustrated embodiment, the panels
corresponding to the nearer strut 14 are removed for clarity in seeing
the panels 48 of the opposing side.
As a practical matter, the panels 48 may be formed of a suitable
polymer, such as an elastomer, a hard or a flexible plastic, a
fiber-reenforced polymer, or the like. Likewise, in order to accommodate
the shape and size of a foot, along with the appropriate pad 18 wrapped
therearound, the panels 48 may have distinctive shapes suitable for
surrounding a member and appropriate to each.
For example, the upper panel 48 is effectively wrapped around the
leg of the user, whereas the lower panel 48 may wrap or instead be
aligned substantially parallel with the wall 28 of the base 12. The
sources 20 may be formed of coils arrayed on front and back portions
(with respect to a direction of motion) of panels 48 affixed to the
Meanwhile, the bed 24 on which the foot of a user rests may be
constructed of multiple layers in order to provide a top witness layer
above a lower cushion or other substrate. Thus, the substrate remains
whether or not the upper witness layer is compromised. By being
compromised is meant that the witness layer may be worn, torn, cut,
abraided, or otherwise rendered broken or removed in order that a
complementary color of the underlying substrate be visible. The visible
underlaying substrate indicates that a user has put pressure, load, or
wear on the witness layer, thus violating prescriptive restrictions on
motion and on weighting the leg, foot, or the like prematurely.
Referring to FIG. 19, a module 50 suitable for mounting a controller
22 to the struts 14 of an apparatus 10 may include a receiver 52 formed
to matingly receive a controller 22. Typically, a retainer 54 may form a
part of the receiver 52, or part of the structure corresponding thereto
in receiving and retaining the controller 22 thereby.
In the illustrated embodiment, connectors 56 are received into the
controller 22 or controller module 22, making electrical contact required
by the controller 22 from power sources within the module 50.
In certain embodiments of an apparatus and method in accordance with
the invention, an indicator 58, an operating button 58, or a combination
thereof 58 may be provided on or near an exterior surface of the
controller 22. For example, an individual may touch the button 58,
causing the button to light, beep, or otherwise indicate as an indicator
58. Thus, the button 58 may serve as a button 58 or actuator 58, as well
as an indicator 58.
The fasteners 32 may capture the strut 14 in order to secure the
module 50 thereto. Suitable embodiments may include one or more of
screws, detents, bosses, clips, slides, and other forms of resistance to
relative motion therebetween. In certain embodiments, the mere friction
maintained by the fastener 34 against the struts 14 may provide vertical
support while brackets, barbs, edges, and other forms of capture
mechanisms may provide horizontal stability capturing the struts 14
within the modules 50.
A port 46 may be of any suitable type. Proprietary formats may serve
well. Nevertheless, inasmuch as many standardized formats have been
developed over decades, selection of a suitable format commonly used such
as a USB, a mini-USB, or other port 46 may provide electronic data access
to the controller 22 by an external programming device, keyboard,
computer, or the like.
Meanwhile, the display 44 may be of any suitable type including
LED's (light-emitting diodes), liquid crystal display (LCD), Nixie lights
or any other suitable format of device for displaying to the user
information output by the controller, inputs received, or other
graphically or alphanumerically displayed characters.
Referring to FIG. 20, the rack 16 may include any suitable number of
connectors 56 as appropriate to transmit power, data, or both. Dedicated
channels may be supported better by use of more than two connectors 56.
Nevertheless, some connectors 56 may provide multiple electrical
connections on a single mechanical connector. By whatever mode, the
connectors 56 provide communication between the power supply and the
controller in the apparatus 10.
Referring to FIG. 21, the rack 16, in an exploded view may be seen
to contain a power source 60. The power supply may use line power,
rectified DC current, or stored power such as batteries 60, or a battery
pack 60 comprising one or more batteries.
In certain embodiments, the power source 60 may be distributed along
two sides of the rack 16, in order to reduce the profile of the apparatus
10. For example, at some point, when a patient is ambulatory or walking
in a "walking cast" apparatus 10, extension of the rack 16 laterally
between the feet or ankles of a user may cause an obstruction to walking.
In the illustrated embodiment, the connectors 56 are secured in the
rack 16 by a set of retainers 62. In general, the retainer 62 may be of
any suitable type and provide mechanical securement of the connectors 56
for support purposes. The connectors 56 may be connected electrically to
wires by soldering, fastening with screws, or the like.
A base plate 64 may secure to the rack 16 maintaining a snug and
immovable fit of the batteries 60 or power source 60 within the rack 16.
Pins 66 or receivers 66 for accepting screws or other fasteners may
penetrate into apertures 68 in the rack 16. Accordingly, fasteners, such
as screws, rivets, glue, solvent, latches, and the like may be used to
hold the pins 66 inside the apertures 68 without moving appreciably.
Accordingly, the base plate 64 may be secured against the rack 16 to
store the power supplies 60 or power sources 60 such as battery packs 60
within the rack 16.
The cavities 70 for receiving the power sources 60 or batteries 60
may be suitably shaped to maintain the mechanical relationship between
individual elements, such as batteries 60. For example, typical batteries
60 have substantial weight and substantially higher density than many
other materials. Accordingly, the batteries 60 may beneficially be
maintained separate from one another in order to not provide noise, not
damage one another, not damage the rack 16, and so forth. Accordingly,
the cavities 70 may be shaped to maintain the batteries 60 each in its
particular location, stabilized in up to three dimensions of space.
An additional benefit of forming the cavities 70 about the power
source 60 according to the shape of the power source 60, may also include
structural efficiency. For example, by providing greater thicknesses and
other dimensions of material in the rack 16 where convenient, while
thinning down or reducing the amount of material in other places, the
overall strength, stiffness, section modules, or the like may be
optimized while minimizing distortion and weight.
Referring to FIG. 22, the controller 22 may include a readout 74
providing actual display of alphanumeric, graphical, or other indications
to a user. The readout may be mounted in a suitable frame 76 or cap 76
suitable for maintaining structural integrity. For example, a display 74
or readout 74 may typically not be particularly robust mechanically.
Thus, the readout 74 may actually need the mechanical protection and
rigidity provided by the frame 76 or cap 76. Meanwhile, a lens 78 may
alter the color, provide glare protection, or otherwise protect the
readout 74 mechanically from damage.
The lens 78 may be secured outside or inside the frame 76 in order
to provide a suitable securement process. For example, the lens 78 may
actually be glued, screwed, riveted, ultrasonically welded or otherwise
bound to the cap 76 or frame 76 in a suitable manner. An aperture in the
lense 78 may provide access to the port 46.
A port 46 may be mounted on a suitable back plate 47 or other
structural member fitted into a bracket 79 in the case 80 suitable for
receiving the back plate 47 of the port 46. In the illustrated
embodiment, the cap 76 or frame 76 is provided with countersunk holes for
receiving a fastener such as a screw that then penetrates into matching
apertures within the case 80. Thus, the cap 76 secures together the
readout 74, the cap 76 or frame 76, and the port 46 all within the case
The circuit board 82 may be fitted to the back of the case 80 or may
be slid into the bottom or the top of the case 80 in any suitable manner
to provide suitable data and power connections. For example, the board 82
may be provided with contacts 84 suitable for making a mechanical and
electrical connection with the connectors 56 from the rack 16. Thus,
whenever the contacts or connectors 56 from the rack penetrate into the
case 80, they are aligned with apertures (not shown) accessing the
contacts 84 on the board 82. Thus, the connectors 56 penetrate into the
case 80 to make contact with the contacts 84 delivering power to the
Referring to FIG. 23, the controller may provide to the sources 20 a
voltage and current suitable for inducing a magnetic field. Accordingly,
each of the sources 20 may include a coil having any suitable number of
turns and any suitable material. For example, the sources 20 may include
5, 10, 20, or any suitable number of turns about an air core or a metal
(e.g., ferro-magnetic core). Accordingly, FIG. 23 illustrates a typical
mode of control relying on controlling voltage applied to a source 20 of
electromagnetic force or electromagnetic flux. In the illustrated
embodiment, the peak voltage is indicated by the letter `V` with a total
elapsed time indicated by `T.`
The actual wave form, including rise time and rate and decay time
and rate of the voltage may be configured in any suitable manner. For
example, in some embodiments, the rise time of the voltage may occur so
comparatively quickly as to appear to generate a square wave.
Nevertheless, even a square wave has a rise time limitation that actually
does not produce the maximum voltage within zero time, but during some
comparatively longer or shorter time period.
Accordingly, the wave shape of the voltage may be altered as to its
rise time and its decay time in accordance with suitable therapeutic
determinations. At this point, it is not considered critical exactly how
the rise time and the wave shape are configured. In order to influence
the piezoelectric properties of bone material, what is needed is an
induced voltage or current within the cells of the body in order to
provide a microexercise operating at a substantially cellular level in
The duty cycle is illustrated by the indicator `n` in the
illustration. For example, any particular fraction or percentage of the
total elapsed time may be filled with voltage cycles as selected for the
time of the duty cycle or the dwell time during which the actual voltage
of the illustrated wave form is applied. A series of voltage waves
oscillating between the maximum and minimum values may occur at a
selected frequence during `n %` of an elapsed time `T.` Thus, the `n %`
of the cycle time `T" (one "duty cycle") defines a period of application
of voltage waves, themselves cycling at a selected frequency (typically
between 50 and 500 Hertz and usually between about 150 and 200 Hertz).
Meanwhile, each period `T` may be repeated during a percentage of the
total time of another therapeutic duty cycle. Thus, for example, a
voltage may cycle at 150 Hertz for 6 seconds of every minute, repeated
five minutes, all repeated once every hour. Thus applied in 24 hours are
twelve minutes of voltage cycling.
Referring to FIG. 24, in one arrangement, a series of sources 20 or
coils 20 may be connected to be actuated together. For example, each
individual source 20 or coil 20 must receive power from someplace.
Whenever a current is run, it may be run through any suitable number of
sources 20 in series. In order to sequence the actuation of these
individual series of sources, different series of coils 20 or sources 20
may be connected separately. Each particular series may be actuated upon
its particular circuit receiving voltage (or current, but actually both,
since they occur together).
In the illustrated embodiment, five separate coils 20 are connected
in series, such that the voltage across the entire series is the
controlled voltage. Accordingly, inasmuch as the five coils are identical
and arranged in series, each has its proportionate share of the applied
voltage. Meanwhile, each is provided the same number of turns, ten in
this instance, and each of the five coils 20 may provide one fifth of the
overall voltage drop applied to the series.
Meanwhile, being connected in series, each of the coils 20 of FIG.
24 receives the same current. The current applied by the power supply
must travel through all of the coils 20 in order to travel through any of
them. Thus, for example, the voltage trace or wave form may be applied to
the series of coils 20 in FIG. 24 as the voltage or power input. In
reality, a power input will provide a voltage and a current. Thus,
application of either voltage or current will necessarily carry with it
the other of these two parameters in order to constitute power used by
the apparatus 10.
Referring to FIG. 25, testing results for one embodiment of an
apparatus and method in accordance with the invention applied various
voltages ranging from six to 24 volts as illustrated in the first column
of FIG. 25. Initially, a frequency of 500 Hz in which `n` the duty cycle
in percentage was five percent. Thus, voltage at 500 Hertz was applied
five percent of the total elapsed time `T.`
It should be understood that the duty cycle may be controlled in
multiple ways. In certain embodiments, the individual coils 20 may be
activated during some overall period of time during which the duty cycle
percentage or `n` is a time period in which an alternating voltage is
applied. Meanwhile, the elapsed time `T` may itself be repeated at some
particular periodicity. Thus, another overall time may represent the
amount of time during which several individual periods (T) are applied.
Likewise, a voltage may be applied (rise) and decayed hundreds of
times per second. With one cycle per second being a single Hertz, a
voltage may be applied and dropped once in a single cycle time `T`. Thus,
a voltage rise may occur and disappear, followed by a lengthy period of
no electrical activity. In another embodiment, the voltage may be applied
and decayed multiple times during the portion `n` of a cycle time `T`.
Thus, the cycle time `T` may represent a single cycle time of application
of voltage, or the cycle time `T` may be an application of voltage
hundreds or thousands of times as alternating voltage at a frequency
during the fraction n or percentage n of an overall time period `T.`
Then `T` may be repeated several times during every larger time
period T.sub.1, which may be repeated several times in a larger time
period T.sub.2, and so forth.
Referring to FIG. 25, the voltage applied ranged from six volts to
24 volts. Meanwhile, the frequency or the number of Hertz was held at 500
Hertz for the first experiment, 500 Hertz for the second experiment, and
200 Hertz for the third experiment. Meanwhile, the duty cycle or the
percentage `n` of the time that the voltage was so alternating for each
time period `T` ranged from five percent for the first experiment to ten
percent for the second experiment and five percent for the third
The magnetic flux densities in micro Tesla are shown. Average
currents in Amperes were likewise as shown. One will note that, for
example, at six volts using a 500 Hertz signal with a five percent duty
cycle, the magnetic flux density is 7.4 micro Tesla. Meanwhile, for the
same frequency with a ten percent duty cycle, the magnetic flux density
is 15.7 micro Tesla, or more than twice the magnetic flux density.
Meanwhile, at 200 Hertz, the six volt power supply provides a magnetic
flux density of nine micro Tesla even at a five percent duty cycle.
Meanwhile, at 16 volts, the 500 Hertz experiment with the five
percent duty cycle produced 18 micro Tesla while the 500 Hertz experiment
at ten percent duty cycle produced a 26.8 micro Tesla result. No longer
is the flux density double for the greater duty cycle. Meanwhile at 200
Hertz, using a five percent duty cycle, the 16 volt experiment produced
14.6 micro Tesla. Thus, the flux density is less than that of the 500
Hertz and five percent duty cycle experiment, whereas at six volts, the
200 Hertz and five percent duty cycle experiment had greater magnetic
flux density than the 500 Hertz and five percent duty cycle experiment.
Thus, it can be seen that the flux density, and the use of power may
be optimized for any particular set of sources 20. Accordingly, the size
of the aperture or core space in each source 20 may be selected and
matched to a particular voltage and current to be run through the source
20 as well as the number of sources 20 or coils 20 to be placed in a
Referring to FIGS. 26 and 27, the laws of electromagnetics indicate
that the magnetic field surrounding a conductor having a current flowing
in a first direction abides by the "right-hand rule." The right-hand rule
states that if the thumb of the right hand is facing in the direction of
current along a conductor, with the fingers of the right hand wrapped
around the conductor, then the direction of the magnetic field is the
direction of the fingers of the right hand wrapped around the conductor.
Thus, in FIG. 26, the conductor current direction applies to all of the
turns within a particular coil 20. Nevertheless, recall that a source 20
may include more than a coil. The coil 20 may contain an air core, in
which the coil 20 is the entire source 20 or may contain a magnetic core
in order to better control, develop, and direct the magnetic flux through
the coil 20.
Likewise, FIG. 27 illustrates a conductor, having a current
direction, and a magnetic field direction. At locations nearest a coil,
the magnetic flux may crowd and curve around the conductor by the right
hand rule. Some distance away from the center thereof, the flux lines may
distribute more widely. Accordingly, magnetic flux lines may be defined
directionally with respect to the conductor, in all three dimensions, as
they propagate through space in their particular geometry.
Referring to FIG. 28, testing results for an experiment ranging from
six volts to 24 volts with a 150 Hertz frequency and a five percent duty
cycle illustrate magnetic flux densities in micro Tesla along the x axis
of FIG. 27, the z axis thereof, and the y axis thereof. X, Y, and Z are
mutually orthogonal. Accordingly, in the illustration of FIG. 27, the
current direction is the Z direction. Meanwhile, the X direction is the
direction radially outward from the conductor, while the Y direction is
the circumferential direction around the conductor.
One will note that the magnetic flux density in a radial direction X
compares with the flux density in the circumferential or Y direction.
Meanwhile, the magnetic flux density along the Z direction of the
conductor or current flow direction is typically an order of magnitude or
more less than that in either of the other directions, which flux
densities are typically comparative.
Referring to FIG. 29, the 150 Hertz experiment was duplicated
through the voltage range from six volts to 24 volts as illustrated, with
magnetic flux densities calculated in the X, Y, and Z directions or along
those axes. Substantial increases in flux densities along the X and Y
axes are apparent and, although smaller, increases are also shown along
the Z axis.
Referring to FIG. 30, the testing results for an experiment at 500
Hertz and a five percent duty cycle illustrate substantially reduced
magnetic flux densities in the X and Y directions, with about the same
proportion of flux density distributed to the Z direction. This
experiment ranging between six volts and 24 volts also illustrates that
the average current Amperage is substantially reduced at this high
frequency compared to the current at the lower 150 Hertz frequency.
Although the five and 10 percent duty cycles of FIGS. 28 and 29,
respectively, are at least within the same order of magnitude of one
another, the increase to 500 Hertz shows a dramatic decrease, in response
to the slower inductive properties of magnets at increased frequencies.
Referring to FIG. 31, the 500 Hertz experiment is repeated at a ten
percent duty cycle, showing marked increases in the magnetic flux
densities along the X and Y axes, with about the same proportional
response in the Z direction as well. Typical current also increases, to
approximately double that of the 500 Hertz and five percent duty cycle
Referring to FIG. 32, the testing results from a 200 Hertz
experiment and a five percent duty cycle in the range of voltages from
six to 24 volts shows a magnetic flux density comparable to the 150 Hertz
five percent duty cycle. Accordingly, the voltage, the frequency, the
duty cycle may be manipulated to provide the appropriate therapeutically
effective magnetic flux density and dwell time or duty cycle desired.
Specific values of parameters such as frequency and flux densities
have been found to trigger somewhat distinctive specific responses in
different tissue types. For example, a specific frequency and micro Tesla
ratings have been found to significantly increase the healing of skin and
open wounds, whereas other frequencies have been found to relieve
inflammation (i. e., reduce swelling and relieve pain). Yet other
frequencies stimulate bone growth.
In certain embodiments of an apparatus and method in accordance with
the invention, the particular frequencies may be selected to be applied
serially, one following another. The applications may be "multiplexed" or
divided in time by increments, each defining a time span in which power
is applied, followed by the next time period, and so forth. Any part of
the foregoing duty cycles discussed above may be so subdivided, whether a
single wave function at a time, a period of constant wave oscillation at
a time, a series of interrupted applications of a continual wave a time,
a duty cycle of any configuration at a time, or an entire treatment
regimen at a time for one single frequency, flux density, or the like for
one period of time corresponding thereto.
Alternatively, one treatment regimen, appropriate to one tissue type
or effect (e.g., relief or pain or swelling, repair of skin damage, etc.)
may be run over minutes, hours, days, weeks or any other appropriate time
period, at one set of parameter values. Thereafter, another regimen
(e.g., repair of muscle trauma, bone healing, bone densification, etc.)
may follow with its own set of parameter values. Thus, whether
effectively simultaneous or sequential, a particular set of treatment may
be programmed and run, each with its own timing and priority.
Thus, several conditions or a single condition of highest priority
may be addressed by an apparatus and method in accordance with the
invention. Pain relief and bone growth may be sequenced or simultaneous,
each as needed and according to the bodily resources' ability to respond
to highest priorities with their most effective means to respond.
In certain embodiments, one may combine all desired frequencies at
once to promote overall repair and maintenance. In another embodiment,
the apparatus and method may cycle through different frequencies during
the use period. Meanwhile, different settings for parameters, different
periods of application of frequency and flux, and different durations of
regimens, as well as distinct starting times hours or days hence may be
programmed into an apparatus to implement such a method to meet a
particular need. Meanwhile, needs may range through pain reduction,
swelling reduction, soft tissue repair, bone fusion, bone density
maintenance, epithelial repair, soft tissue maintenance to exercise at a
micro level to replicate everyday bodily use, each at the flux density
and frequency determined to be most effective for each intended regimen.
Referring to FIGS. 33-36, while continuing to refer generally to
FIGS. 33-49, a pad 18 may be arranged with any number of series of
sources 20. For example, in the illustrated embodiment, the pad 18 is
provided with numerous sources 20 mechanically laid out in an array.
The pad 18 may have an inner portion 88 or inner layer 88 over a
center layer 90 or center portion 90, all covered with an outer layer 92.
Apertures 94 may be formed to be fitted with sources 20. Each source may
be made up of a spool 98 supporting a coil 100 of wire 101. Each spool 98
may be made up of a drum 102 or drum portion 102 flanked on either end
thereof by flanges 104 or flange portions 104.
One or more tabs 106 on at least one flange 104 may serve to secure
each spool 98 to the center layer 90 to secure the spool 98 with respect
thereto. The apertures 108 in the tab 106 may receive therethrough a
thread or other fastener. A suitably soft polymer or composite may not
require an aperture 106, if a needle us used to simply penetrate some
portion of a tab 106, flange 104, or both.
Referring to FIG. 36, while continuing to refer to FIGS. 33-49,
various portions of the mechanical array may be electrically connected in
various series, such as series A, series B, and so forth up to some
number of series that represents the maximum, such as the series n. Each
series represents one circuit. Each of the sources 20 in one series will
be energized at the same time by a source of voltage, current, or
Either voltage or current is typically controlled, and the other
relies on the response of the circuit. Thus, the number of sources 20,
the number of turns in each, the presence or absence of a magnetic core,
the wire size, the frequency of application of the current, and the like
may control the specific current traveling through each source 20 upon
application of a particular voltage.
The pad 90 or the inner layer 90 of the mat 18 may be thermally
bonded fabric. Meanwhile, a computerized numerical control may be used to
automatically place cores and cut fabric. Meanwhile, various taped strips
of coils may also be used to fabricate series of coils suitable for
placement within the inner layer 90 of the pad 18.
For example, a pair of layers of synthetic fabric, such as a
non-woven fabric formed of a synthetic fiber may travel through a machine
laying coils either in the direction of travel of the material, or
orthogonal to the direction of travel. Accordingly, computerized
equipment may apply pressure and heat at selected locations, such as the
center of a coil 20, the periphery of a coil 20, or both. Thus, the
fabric may fix and preserve the location of each of the coils or sources
20 with respect to itself.
For example, in one embodiment, a tool may apply a ring of pressure
and heat just inside the inner diameter of one of the sources 20.
Meanwhile, at the same time, or at another time, a tool may apply a
circle of heat around the outer periphery of the coil or source 20. Thus,
the source 20 may be completely stabilized within fabric without the need
for any spool 98 therewithin.
The thickness of the wire 101 of the coils 100 may be minimized by
removing any external insulation layer. For example, magnet wire may be
formed to have a flexible enamel on the outer surface thereof, thus
providing insulation that is more integral with the wire 101. In this
manner, the wire diameter may be very thin, and the inner core 90 of the
pad 18 may be particularly flexible and soft, without the need for thick
layers of padding in order to obscure the effects primarily of the spool
Of course, the spool 98 may be made small, thin, and so forth,
including being made of a very soft elastomeric polymer. Nevertheless,
the spool 98 may be dispensed with in favor of stabilizing each of the
coils 100 within fabric itself. In fact, in certain embodiments, the
entire pad 18 may be bonded periodically by thermal bonding, if made of a
synthetic material suitable for bonding by addition of heat and pressure.
In this manner, the coils may be stabilized, yet the overall pad 18 may
be made comparatively thin or thick according to comfort, rather than
being subject to excessive mechanical constraints due to the mechanics of
the sources 20 and their optional spools 98.
Referring to FIG. 37, in one embodiment of an apparatus in
accordance with the invention, spools 98 may be secured to a core 90 by a
series of pedestals or bollards 109. In the illustrated embodiment, the
basic mat 90 or core 90 may be formed of a flexible layer of a polymer,
such as an elastomeric solid sheet or layer of expanded foam material.
Meanwhile, by vacuum forming, pressing, die stamping, blow molding, or
the like, the core 90 may be formed to have small bollards 109 to receive
In the illustrated embodiment of FIG. 37, the bollards are provided
with a main pedestal and a top keeper that provides a detent to secure
spools 98 thereto. Accordingly, spools 98 may be snapped onto the
bollards 109 to locate and stabilize each of the coils 100 therearound.
Meanwhile, an outer layer 92 may be applied by bonding, heat, or the like
at the top of each of the bollards 109 in order to close in the coils 100
and their respective spools 98.
Referring to FIG. 38, in one embodiment, non-woven fabrics may be
used, thus reducing costs substantially for the central portion 90 of the
pad 18. Nevertheless, woven fabrics may be used as well. However,
typically, synthetic fabrics formed of polymers based on petroleum
typically have melting temperatures lower than those of natural fibers
such as wool, cotton, flax, and the like. Likewise, certain natural
fibers will not effectively bond by melting.
Thus, in one embodiment of an apparatus and method in accordance
with the invention, a layer 110 of fabric may receive a coil 100 applied
thereto. Meanwhile, an anvil behind the layer 110 (not shown) may be
heated or may simply provide a resistance to the pressure applied by
another tool such as a sealing head 120 or a head 120 providing heat and
In one embodiment, a layer 110a of fabric 110 may have a coil 110
laid thereagainst, after which, a bonding ring 112 may be formed in the
center of the coil 100, around the outside thereof, or both. For example,
the core region 114 of the coil 100 may be separated away from the coil
100 by the head 120 applying pressure and heat to the layer 110b of the
fabric 110 thus forming the bonding ring 112 of bonded fabric within the
inner perimeter of the coil 110.
Accordingly, the spool 98 is actually formed simply by the bonding
ring 112 acting as the drum 102 inside the coil 100. Meanwhile, tack
welds 116 at strategic locations, or a ring about part or all of the
entire periphery outside the coil 100, may bond the layers 110a, 110b
together. Thus, the coil 100 is captured and stabilized inside a fabric
spool, whose dimensionality is preserved by the fabric 110 itself. Any
appropriate number of the coils 100 may be so bonded between layers 110a,
110b, of any extent. In the illustrated embodiment, the layers 110 may be
formed into a tape 118. Thus, the layer 110a may be continuous while the
layer 110b may be discontinuous patches of the fabric 110. Between any
two coils 100 the fabric 110 and wires may be cut and controlling power
leads attached to the wires.
By applying a ring or even a complete cylindrically filled plate
122, the bonding ring 120 or the head 120 may form the bonding ring 112.
If a magnetic core is to be applied in the core region 114, then such a
core may be captured within the bonding ring 112 during the bonding
process. The hot plate 122 or hot ring 122 may thus be designed according
to whether or not a magnetic core will be captured in the core region 114
Referring to FIG. 39, in one embodiment of a pad 18, various coils
100 may be bonded by any suitable mechanism. For example, the method of
FIG. 38 may be made to have a somewhat sophisticated shape of die
representing the function of the hot ring 122. If a head 120 can be made
in a suitable shape, then a single application of pressure and
temperature along the entire pattern of the pad 18 may stamp the coils
into a stable relationship with the pad 18. In alternative embodiments,
the coils 100 may actually be printed on a substrate that is then bonded
to the pad 18.
Of course, in accordance with previous embodiments discussed
hereinabove, the wire coils may be embedded in the pad 18 by
thermo-pressure bonding of the fabric materials together, thus capturing
the coils therein.
Referring to FIGS. 40-41, one embodiment of a pad 18 suitable for
use around or within an arm splint or cast may include an upper arm
portion 124 connected to a lower arm portion 126. A gap 128 may be
provided in order to provide relief for closure at the inside surface of
an elbow of a user. In one embodiment, an aperture 130 may be required
for a thumb. Nevertheless, in some embodiments, the cast may terminate at
the wrist in order to immobilize an elbow, without necessarily requiring
immobility of a hand.
Various types of fasteners 132, such as hook-and-loop fasteners, may
provide securement of the pad 18 to itself. For example, the upper arm
portion 124 may wrap around the upper arm of a user, being secured to
itself by a fastener 132, such as a fastener strip 132. Likewise, after
bending, the lower arm portion 126 may then be formed to wrap against
itself by suitable fasteners 132, such as a fasteners strip 132 or other
fastener mechanism as appropriate.
Referring to FIGS. 42-43, a wrap 18 or pad 18 suitable for use on a
foot, leg, or both of a user may include a leg portion 134 and a foot
portion 136. The leg portion 134 and foot portion 136 may be formed of a
single piece of material having a suitable gap portion 128 in order to
relieve the bunching of extra material at the inside of the bend formed
therein upon application to a user. In the illustrated embodiment, as in
the embodiment of FIGS. 40-41, the pad 18 may be a pad 18 in accordance
with the invention having a number of sources 20 having coils 100 arrayed
in any suitable format for applying electromagnetic flux to the foot, to
the ankle, to the leg, or any combination thereof. The pads 18 may
contain a splint (not shown), be used with a cast 10 system, or the like.
Referring to FIGS. 44-45, a pad 18 for application to the wrist and
hand of a user may include a wrist portion 138 and a hand portion 139.
The wrist portion 138 and hand portion 139 may be suitably shaped to wrap
around a wrist and hand of a user, relying on a closure 132 or multiple
closure sections 132. In certain embodiments, a series of straps,
buckles, fasteners, and the like may be used to wrap the pad 18 around a
bodily member and fasten to itself or secure it to itself. Nevertheless,
in one embodiment, hook-and-loop fasteners may be provided to act as the
fastener segments 132. Likewise, an aperture 130 for receiving a thumb
therethrough may also be provided as appropriate.
Referring to FIG. 46, a wrap 18 or pad 18 made in accordance with
the invention may be configured in a shape suitable or operating as a
collar about a neck of a user. Similarly, a fastener portion 132 may
secure the wrap 18 back to itself. Meanwhile, in certain embodiments,
pads 18 may be formed in various shapes. For example, in certain
embodiments a bodily member may be elevated by a wedge shape, or bodily
members may be needing separation from one another. Accordingly, various
shapes of pads, pillows, wedges, and the like may be formed in order to
position or separate bodily members. Meanwhile, each may be provided as a
wrap 18, having a central portion 90 shaped as appropriate in order to
provide the suitable sources 20 proximate to members of a recovering
Referring to FIG. 48, a pad 18 generally may be provided in any
suitable shape, including a simple flat shape that may be wrapped around
a bodily member at any substantially constant diameter. For example,
fasteners 132 may be provided to secure the pad 18 around a member of a
user. Similarly, a bodily member such as a forearm, calf, or the like may
have a tapered shape requiring a more specific fit. Accordingly, such a
shape may be formed as a trapezoid that will wrap to form a somewhat
conical wrap 18 or frustum of a cone.
Referring to FIG. 49, for example, the pad 18 may be wrapped around
a bodily member providing a maximum and minimum diameter when the
fasteners 132 secure the pad 18 to itself. Thus, a bodily member having a
substantial taper may benefit from the shape of the pad 18 of FIG. 49.
Meanwhile, a pad having a rectangular shape, as in FIG. 18, and of
suitable length-to-width ratio, may be used about an abdomen, an arm
having less dramatic shape change, a collar, or the like.
Referring to FIG. 50, a pad 18 may include a pocket 140 to hold a
controller 22, the power supply 60 or source 60 of power, and the like.
In one embodiment, a pocket 140 may be provided a closure 142 secured by
fasteners 132. Thus, a set of wires 42 or power lines 142 may proceed
from the power supply 60 to a remote controller to magnetic sources 20,
or both. For example, the controller may operate in the vicinity or in
the same pocket 140 with the power supply 60. Alternatively, the power
supply 60 may be provided with wires 42 to a controller remote therefrom.
Referring to FIGS. 51-52, for example, the pocket 140 of FIG. 50 may
apply to a dressing 150. In the illustrated embodiment, a dressing 150
may include an array of sources 20 containing coils 100, receiving power
through a connector 156 on a substrate 152. In certain embodiments, a
substrate 152 may provide the structural material establishing a
protective cover or the like for a dressing 150. Accordingly, a cover 154
may provide a clear or opaque covering over an array of sources 20 of
electromagnetic force or electromagnetic flux. The coils 100 of the
sources 20 may connect by wires 42 to a connector 156. The connector 156
may have a mating portion connecting to the wires 42 in a power supply as
illustrated in FIG. 60.
In accordance with one embodiment of an apparatus and method in
accordance with the invention, the connector 156, may establish
separation between a dressing 150, which may need to be changed, and the
power supply 60 that may benefit from being used to exhaustion of the
Referring to FIG. 52, while continuing to refer generally to FIGS.
50-52 and while continuing to refer more generally to all FIGS. 1-59, a
substrate 152 may include perforations 158. Meanwhile, a connector 156
may be provided as illustrated in detail in FIG. 51. A sealed insert 160
may be provided permitting passage of air or moisture therethrough in
accordance with the primary functions of various types of dressings 150.
For example, the perforations 158 may pass through multiple layers
including a top layer 162, a bottom layer 164, and the intervening
sources 20 with their incorporated coils 100 therein. Thus, the connector
156 may provide access to the outside environment, and connect to the
wires 42 of a power supply 60.
The controller 22 may be a simple matter of digital control, or even
a matter of on/off control. In certain embodiments, a small oscillator
with cycle control may be embedded in the controller 22 secured to the
power supply 60 controlling power through the application of voltage,
current, or the like as may be selected as the controlled parameter
applied to the wires 42.
Meanwhile, wires 42 continue past the connector 156 and on to the
sources 20. Meanwhile, the perforations 158 may actually operate as
seals, sealing the sources 20 away from any liquids that may be picked up
by the gauze 168, filler 168, or other absorber 168 of the dressing. The
absorbent material 168 may be any suitable material in one or more layers
as contemplated in the medical arts. Thus, the perforations 158 provide
access to ambient air for drying of the absorbent material 168. In
certain embodiments, the sealed portion 160 may be bonded to the
substrate 152, and perforated thereafter, with the perforations 158
aligned with respect to the interior portions of the coils 100 of the
sources 20 in particular.
Referring to FIG. 53, connectors 169a, 169b may provide an interface
between the program system 170 or software system 170 of the apparatus
10. For example, in certain embodiments, the system 170 may actually be
embedded in firmware. Regardless of the implementation scheme, the system
170 may connect by the connector 169a to a keyboard, computer, or the
like. Accordingly, a programmatic control interface 172 may provide
communications to a user through a keyboard, controller, control module,
computer, or the like. Thus, an individual user, medical professional,
patient, or the like may provide programming into the system 170 through
the programmatic control interface 171 upon connection through the
connector 169a to a suitable user interface.
Meanwhile, a user interface 172 within the system 170 provides
information for operating with some other user input device such as a
computer or keyboard, user output device such as a display, or both.
Thus, the user interface 172 is responsible to provide queries, prompts,
feedback, or the like required to enable and inform a user in programming
the system 170. An input module 173 may accept inputs, and provide data
exchange with the user interface in order to operate with the hardware
and software embedded within the system 170.
In certain embodiments, a prescription module 174 may provide
certain standardized regimens. Those regimens may be established by
research and medical professionals in order to provide certain
standardized, therapeutic formats easily addressed by simple identifiers
such as plan numbers. In certain alternative embodiments, the
prescription module 174 may interface with a computer of a doctor or
other medical professional prescribing a regimen.
Thus, the prescription module 174 may include memory locations for
receiving a particular prescription of a user. The prescription module
174 may store a prescription for a cycle description, a time period, or
an extended time period with multiple applications throughout multiple
days of various regimens.
In certain embodiments, various control attributes 175 may be
provided. For example, a system 170 may control current, voltage, or the
like. Meanwhile, the system may be programmed to monitor various
parameters overtime, such as the current and voltage, and may record
them, prescribe them, or the like.
In some embodiments, various days counted from a particular
beginning of therapy, days of the week, days of the month, or the like
may be provided as control attributes for regimens supplied to a user.
Meanwhile, times, including start time, stop time, operation time, duty
cycle setting, and the like may be provided. Meanwhile, sequences for
sequencing the particular sources 20 that will be operated, or the
particular series of coils 100 that will be activated at any time, may be
Startup information may include start times, beginning voltages,
wave form shapes, frequencies, and the like controlling the starts.
Likewise, stops, including wave form decays, something as simple as wait
and start times, or the like may be specified. Delays between cycles,
whether those cycles are individual applications of a particular wave
form, periods of application of high frequency wave forms, and the like
may be provided.
For example, the dwell time between regimen parameters of any type
may be specified. The time between application of electromagnetic forces
may be very long. For example, in some embodiments, it is contemplated
that a regimen may operate for minutes, with multiple starts and stops
for short duty cycles within those minutes. Meanwhile, the entire process
may then stop for many minutes or even hours. Meanwhile, that regimen
within an hour or hours may be repeated within days. Accordingly, all
those starts, stops, and delays may be programmed into a regimen.
Likewise, frequencies of oscillation of voltages or other applied
power parameters may be specified. Likewise, repetition of cycles may be
varied. For example, in some embodiments, a regimen may include
application of a particular wave form at a particular voltage for a
particular number of cycles, all of which may be changed in subsequent
applications within the same regimen. Accordingly, all of those
frequencies with their appropriate starts, stops, and delays, may be
applied as control attributes.
Typically, feedback is a very important part of medical observation.
Accordingly, a historical log 176 may keep track of dates, times, various
events, patient status, wave forms, any of the control attributes, and
A power controller 177 may provide the interpreted result of the
inputs and control attributes as they will be applied to the actual
sources 20. Meanwhile, the power wave form generator 178 may receive or
operate to provide the particular voltage or current as a function of
time for any particular cycle, for any particular combination of cycles,
and for the complete regimen. Thus, the power wave form generator 178 may
provide the control information that will control the sources 20 as they
receive power from the power controller 177.
Likewise, power conditioning 179 may be required in order to use the
apparatus 10 with various sources of power. For example, in certain
embodiments, the apparatus may be plugged into a wall outlet and use
local line power. In other embodiments, the system 10 may work from
batteries 60. Accordingly, the power from the power source 60 whether
batteries 60 wall line power 60, or the like may require power
conditioning controlled by the power conditioning module 179.
Ultimately, the operating unit interface 180 sends signals to the
sources 20 based upon the inputs received, as translated into actual
control of the voltage, current, or the like being applied to each
particular series in sequence according to the regimen prescribed.
Referring to FIGS. 54-59, an apparatus 10 in accordance with the
invention may include a control module 182 operable by a user. In certain
embodiments, the control module 182 may be replaced by a computer, a
keyboard, or other suitable computer interface appropriate to communicate
with the controller 22. In certain embodiments, the control module 182
may be provided with a port 184 suitable for receiving a connection or
other interface with the apparatus 10, a programming computer downloading
data, both, or the like.
For example, in certain embodiments, the port 184 may actually
connect to a flash drive, or USB line, thus connecting the control module
182 to the controller 22 for programming. In certain embodiments, a
series of buttons 186 on the control module 182 may provide input by a
user of the control inputs for the apparatus 10. In certain embodiments,
the button 186a may operate to power the system on or off. Meanwhile, the
button 186b may then provide a user with the ability to set the level, to
scan through menus on the display 44, or otherwise program or set
parameters for the controller 22.
Thus, In certain embodiments, a control module 182 may provide a
remote device not requiring any computer, keyboard, or any other
interface. For example, if the display 44 of the controller 22 can
display menus, cycle through alpha-numeric data, or even provide
graphical information, then the controller module 182 may provide an
interface for a user to program directly the controller 22 according to a
In certain embodiments, of an apparatus and method in accordance
with the invention, a user may download applications through the control
module 182, and detailed regimens or prescriptions to be loaded into the
By the same token, the user may program directly, when convenient,
through the port 46 of the controller 22 any desired control information
passing into the controller 22. Nevertheless, a benefit of the control
module 182 is that a user need not be near a computer in order to operate
the system 10 in accordance with the invention.
Connectors 184a, 184b, are optional interfaces for communicating
with power supplies, wraps 18, sources 20, or the like. Each is optional
and may receive power in, send power out, both, or be absent in any
Buttons 186 on a control module 182 may be added as convenient for
ease of use and understanding by a user. The module 182 may record data
such as how often the system 10 is worn, operated, walked on, or the
A pedometer may be fitted to the apparatus 10 to detect use, whether
proper or improper, by a wearer. Thus, an actuator may move due to
contact with a walking surface, thus activating a detector, counter, or
the like. The detector may report to the controller 22, control module
182, or the like. Thus a medical professional may obtain a log of proper
and improper use by a user.
The present invention may be embodied in other specific forms
without departing from its spirit or essential characteristics. The
described embodiments are to be considered in all respects only as
illustrative, and not restrictive. The scope of the invention is,
therefore, indicated by the appended claims, rather than by the foregoing
description. All changes which come within the meaning and range of
equivalency of the claims are to be embraced within their scope.
* * * * *