U.S. patent application number 11/124721 was filed with the patent office on 2006-06-08 for therapeutic device for local area stimulation.
Invention is credited to Nikolay Alekseyenko.
Application Number | 20060122453 11/124721 |
Document ID | / |
Family ID | 46321986 |
Filed Date | 2006-06-08 |
United States Patent
Application |
20060122453 |
Kind Code |
A1 |
Alekseyenko; Nikolay |
June 8, 2006 |
Therapeutic device for local area stimulation
Abstract
This invention, fundamentally a regular array of points, is
applied non-invasively to a subject and it induces, monitors and
controls a variety of therapeutic stimuli. It is effective in novel
and non-obvious ways when the points are spaced approximately 3 to
6 mm apart. Further development includes patterns of
electromagnetically dissimilar metal points, a magnetized support,
and configurable electrical connections along with various
controllers and stimulus sources. This device can administer an
unprecedented variety of therapeutic stimuli in unprecedented
combinations. Effects arise galvanically, through interaction of
point arrays with the magnetized support, and by application of
electromagnetic forces. It can electronically monitor both stimuli
and local subject response through the points themselves enabling
effective controls and an avenue for research. Its flat shape
accomodates accessories to apply other stimuli such as heat. A
clinical version accomodates invasive treatments and bulky external
devices.
Inventors: |
Alekseyenko; Nikolay;
(Pacifica, CA) |
Correspondence
Address: |
Nikolay Alekseyenko
154 Outlook Circle
Pacifica
CA
94044
US
|
Family ID: |
46321986 |
Appl. No.: |
11/124721 |
Filed: |
May 7, 2005 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
11002781 |
Dec 2, 2004 |
|
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|
11124721 |
May 7, 2005 |
|
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Current U.S.
Class: |
600/9 |
Current CPC
Class: |
A61H 39/08 20130101;
A61N 2/00 20130101; A61H 39/04 20130101; A61H 2201/10 20130101 |
Class at
Publication: |
600/009 |
International
Class: |
A61N 2/00 20060101
A61N002/00 |
Claims
1. A therapeutic device comprised of a. an array of points, and b.
said array protruding from a supporting material or structure, and
c. at least some of said points approximately 3-6 mm apart.
2. The device of claim 1 wherein said support is flexible.
3. The device of claim 1 wherein said support is magnetized.
4. The device of claim 1 wherein said points are made with
metal.
5. The device of claim 4 wherein said points are of two classes:
diamagnetic and ferromagnetic.
6. The device of claim 5 wherein said classes of points are
assembled in some alternating arrangement.
7. The device of claim 4 wherein said points are interconnected
with electrical conductors comprising: a. interconnections within
some classes of points, and b. controllable connections between
classes of points.
8. The device of claim 7 wherein points or classes of points may be
selectively and separably monitored.
9. The device of claim 7 wherein signals or forces applied to
points or classes of points may be selectively and separably
controlled.
10. The device of claim 4 wherein provisions are made to apply,
allow, or monitor electromagnetic forces through the points.
11. The device of claim 10 including: a. power, force, and signal
sources, b. sensors, c. controls and access for said sources and
sensors.
12. The device of claim 11 wherein said controls and sensors
operate: a. manually by direct settings, or b. by the device itself
through feedback loops, or c. algorythmically or
programmatically.
13. The device of claim 12 wherein monitoring information is
derived from external sources.
14. The device of claim 10 wherein forces affecting points may be
monitored concurrently with application of forces to the points
themselves or other points.
15. The device of claim 1 wherein said device physically
accommodates optional accessories to be layered with it in use.
16. The device of claim 15 wherein there is an accessory source of
heat or cold.
17. The device of claim 1 wherein the points of said device exert
uniform pressure on the subject by means of padding.
18. The device of claim 1 wherein said device accommodates physical
access to the subject by other devices, instruments, monitors,
sensors, or therapies.
19. The device of claim 18 with provision to attach one or more
hypodermic needles and tubing reliably and safely.
20. The device of claim 18 wherein said accessories provide means
of application or monitoring of other therapies singly or in
combination including, but not limited to, electromagnetic forces,
acupuncture needles, vibration, distension and pressure.
Description
[0001] This application is a continuation in part of application
U.S. Ser. No. 11/002,781, filed Dec. 2, 2004.
[0002] The Inventor is Nikolay Alekseyenko, a citizen of the United
States, residing at 154 Out-look Circle, Pacifica, Calif.,
94044
CROSS REFERENCE TO RELATED APPLICATIONS
[0003] Not Applicable
STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT
[0004] Not Applicable
REFERENCE TO SEQUENCE LISTING, A TABLE, OR A COMPUTER PROGRAM
LISTING COMPACT DISC APPENDIX
[0005] Not Applicable
BACKGROUND OF THE INVENTION
[0006] This invention pertains to the field of devices used by
healing arts and medical practitioners to stimulate healing
responses and promote health in their subjects as well as the field
of devices used to investigate biophysical phenomena, including
phenomena associated the use of this instrument to apply a variety
of stimuli.
[0007] Healing Arts practitioners in a wide variety of disciplines
and traditions have long observed the therapeutic value of a great
variety of local stimuli.
[0008] From hot water bottles to acupuncture needles, from
electrical currents to magnetic fields, and from massages to
plasters, many stimuli are recognized as helpful components in
therapy. They are administered continuously or intermittently,
constant or modulated, over a wide range of intensities from
extremely fine to much higher, and, in the case of electrical and
magnetic stimuli, with constant or alternating polarities.
[0009] Fields of practice using such stimuli include sports and
rehabilitative medicine, physical therapy, acupuncture,
acupressure, therapeutic massage, and less traditional practices
such as magneto-therapy and reflexive therapy.
[0010] A number of devices have been invented to aid in
administering therapeutic stimuli. Following are descriptions of
four such devices cited as examples of prior art.
[0011] A device for intramuscular stimulation therapy applies local
electric currents and is described in U.S. Pat. No. 6,058,938 to
Chu and Styles (1998). It has an electric battery power source
connected to conductive tips held on Teflon handles and inserted
subcutaneously.
[0012] Shortcomings of this device include: [0013] a. It is
necessarily invasive, requiring insertion of the points. [0014] b.
It lacks control over the polarity and amount of current applied.
[0015] c. The device itself is not responsive to changes in the
patient, such as polarization and resistivity around the inserted
electrodes, during the course of administration. [0016] d. It is
dependent upon external power supplies. [0017] e. It does not
administer other stimuli such as heat and constrains their
simultaneous application.
[0018] Another related device is proposed in U.S. Pat. No.
4,590,939 to Sakowski (1984). It is used to reduce pain according
to acupressure principles through application of local mechanical
pressure.
[0019] Shortcomings of this device are that its use precludes
simultaneous administration of other stimuli singly or in
combination. The gross mechanical motions it induces are
incompatible with numerous conditions including lesions, surgical
wounds, bruising, ulcerations, or infections.
[0020] A third device is proposed in U.S. Pat. No. 4,319,574 to Sun
and Sun (1980). It also applies physical pressure and is used to
stimulate "Biologically Active Spots" (BAS). It consists of a flat
plate with two protruding parts that move against each other by
means of an electromagnet. The parts have adjustable positions set
by selectable stops.
[0021] Shortcomings of this device include: [0022] a. It neither
provides nor permits simultaneous application of other stimuli
singly or in combination. [0023] b. It requires an external
electrical power supply. [0024] c. It requires time-consuming
procedures to set up. [0025] d. It is dependent upon external power
supplies. [0026] e. It does not administer other stimuli such as
heat and precludes their simultaneous application.
[0027] These three above-described devices are limited to
administration of one type of stimulus and make simultaneous
administration of other stimuli impractical. They are localized to
one point, or, in the case of the first device, a line between two
points.
[0028] The fourth device, actually a range of devices based on one
fundamental feature, superficially resembles the present invention
but fails to exhibit the novel, unexpected and useful properties
seen in my invention. Inventor and healing practitioner Igor
Kuznetsov developed his "IPLIKATOR" (an acronym sounding like the
word "applicator") in Russia in 1980. Kuznetsov's writings and
marketing materials cite ancient traditions such as the India's
fakir's lying on beds of nails or walking on beds of burning coals
and Chinese acupuncture as precedents for his invention. All
versions of his device employ points (thermoplastic) spaced 1 cm or
more apart, or--uncommonly--needles (metal) spaced at least 8 mm
apart. A variation of the IPLIKATOR dubbed Panacea has been offered
for sale in North America and is comprised of a pad with integral
molded points, similarly spaced.
[0029] Kuznetsov's device, in the form sold over the counter in
Russia until the collapse of the Soviet Union, has molded plastic
points spaced approximately 1 cm apart. A version with metal
needles set 8 mm apart was used in clinical settings. Kuznetsov's
instructions for using his device reflect the fundamental
difference between it and the present invention. Unlike the present
invention, Kuznetsov's instructions for use reveal a singular
feature of his device: it depends on physical pressure being
applied at maximum tolerable pain levels until no longer tolerable
followed by release of the pressure for relief followed by a repeat
application of maximum tolerable pressure and so on until the
desired response is noted, or, in cases of local application, the
underlying musculature becomes entirely limp and "the points press
against bone." Following proper application, subjects' skin, though
not lacerated, is characteristically marked by epidermal abrasions
where the points have pressed and surrounded by "stretch marks"
indicating acute distention of the skin radiating out from the
points. The device works through mechanical distention of skin and
underlying tissue in a species of massage and by inducing intense
pain. Both aspects depend on mechanical pressure being applied to
points that are spaced far enough apart to significantly deform the
skin surface.
[0030] Kuznetsov and his followers cite the mechanical deformation
and the pain as intrinsic to the use of the device and its effects.
They conjecture in addition that pushing 100's or 1,000's of spots
will inevitably hit a few "acupuncture points" as well, with
therapeutic benefit. This claim is considered thoroughly absurd by
practitioners of acupuncture whose treatments are sub-dermal and
skillfully directed to a few carefully selected locations.
[0031] Use of IPLIKATOR--Panacea devices without intense pain and
pressure give results akin to meditative or training practices such
as wearing a hair shirt or repeated skin pinching.
[0032] Kuznetsov's marketing materials claimed protection for the
device through a Russian author's certificate but anecdotal reports
averr his certificate was for an unrelated invention in the early
1970's. Whatever his certificate covered I have not seen it
precisely identified in connection with IPLIKATOR-Panacea devices,
perhaps because it was in fact unrelated to them.
[0033] Shortcomings of this fourth device include: [0034] a. It
depends on mechanical manipulation and induced pain for its
effects. [0035] b. The points must be spaced far enough apart to
accomplish mechanical distension and induced pain, precluding the
novel and unexpected effects produced by the present invention
which depends on a higher density of points. [0036] c. The high
number of regularly spaced points precludes effectiveness according
to the principles of acupuncture and acupressure, contradicting
claims made for it. [0037] d. If it is used to apply electrical
stimuli, the stimuli, being applied so far apart, fail to function
in the novel and unexpected manner seen in use of the present
invention, [0038] e. Despite claims made for it, application of
electrical stimuli with the device also fail to function according
to principles of acupuncture and acupressure. [0039] f.
Galvanically-induced electromagnetic effects are not induced or
employed by this device. No field variations or arrangements of
differing materials is used. [0040] g. Applied magnetic fields have
not been incorporated with this device, and the wide spacing of its
points, lack of interconnections between them, and lack of
arrangements of electromagnetically dissimilar materials precludes
the field modulations observed with the present invention. [0041]
h. No provision is made for concurrent use of subcutaneous
injectors or other applicators or sensors with this device. [0042]
i. Kuznetsov's writings clearly assert that induced pain and
mechanical pressures are necessary to the device's effectiveness.
[0043] j. The device, when used according to its inventor's
instructions, creates epidermal abrasions and local dermal
trauma.
BRIEF SUMMARY OF THE INVENTION
OBJECTS AND ADVANTAGES OF THE PRESENT INVENTION
[0044] Accordingly, besides the objects and advantages of the
devices described in the above description of prior art, several
objects and advantages of the present invention are: [0045] a. to
provide gentle and non-invasive therapeutic stimuli across areas of
a subject's body surface with points in arrays--to some degree or
entirel--regular and spaced 3-6 mm apart novel and unexpected
benefits unique to such arrays and other benefits; [0046] b. to
galvanically provide fine degrees of electrical potential or
current and electromagnetic fields without external power sources;
[0047] c. to apply stimuli evenly over an area of application while
varying them at smaller scales, further varying them at these
smaller scales by optionally incorporating differing materials,
arrangements and interconnections of the point arrays; [0048] d. to
optionally apply stimuli in differing degrees or kinds to
selectable sub-portions of the area of application; [0049] e. to
optionally apply various types of electrical, modulated, or
magnetic stimuli as required; [0050] f. to optionally apply heat or
cold to the area of application; [0051] g. to monitor physical
changes in the device, e.g. field polarities, magnetic moment, or
electrical resistance at selectable areas of application during a
course of treatment; [0052] h. to provide electrical and magnetic
stimuli in any strength needed; [0053] i. to provide variation,
modulation, and control of electromagnetic stimuli over time;
[0054] j. to accommodate simultaneous topical or subcutaneous
administration of medicinal substances and/or additional, highly
localized stimuli; [0055] k. to activate, potentiate, or
synergistically enhance medicinal substances by means of
electrical, magnetic and/or thermal fields; [0056] l. to optionally
function autonomously without external power sources or with
external power sources as appropriate; [0057] m. to provide
optional self-regulating or ad hoc regulation of therapeutic
stimuli; [0058] n. to provide a variety of practical advantages
including immediately available alternate configurations,
portability, and minimal setup; [0059] o. to provide the above
functionality in separable components or modules which operate
singly or in combination; [0060] p. to provide optional means for
additional therapeutic administrations including, but not limited
to, invasive techniques, additional controls, or monitoring
devices; [0061] q. to "do no harm" by functioning safely in
proximity with inflamed, injured, lacerated, sensitive, or delicate
subject tissues; [0062] r. to provide, through replaceable modules,
a wide variety of sources of stimuli and controllers--both manual
and automated--for said stimuli, as well as to provide con-current
means of monitoring the stimuli, their biophysical effects, and
biophysical conditions or responses within the instrument's domain
of influence; [0063] s. to provide a platform for quantifiable,
scientific research into extended ranges and combinations of
hitherto mutually incompatible therapies. By using the
unprecedented variety of field effects available through its use,
this invention, with supporting instruments, may open doors to new
fields of biophysical research, and, it is hoped, thereby lead to
deeper understanding of life, health and healing.
SUMMARY OF THE PRESENT INVENTION
[0064] In accordance with the present invention the therapeutic
device for applying local area stimuli is an array of metal points
set approximately 3 mm to 6 mm apart, arranged in rows alternating
between ferromagnetic and diamagnetic materials, and held in a
flexible, magnetized support, the combined parts so connected and
deployed as to effectively administer and monitor a wide variety of
physical stimuli singly or in combination and provide means to
effectively monitor coincident and concurrent biophysical responses
to these stimuli both for therapeutic purposes and as a tool for
scientific research into phenomena revealed through this
invention's development and use.
DRAWINGS
[0065] Drawing Figures with brief descriptions are listed here
below.
[0066] FIGS. 19 or 21 may be considered suitable Front Page
Views:
[0067] FIG. 01 is an array of points.
[0068] FIG. 02 is a flexible base block.
[0069] FIG. 03 is a point array embedded in a flexible base block,
viewed from the active, proximate [front] side.
[0070] FIG. 04 is a point row.
[0071] FIG. 05 is a conductive strip.
[0072] FIG. 06 is the point row and the conductive strip assembled
into a point row assembly with a conductive wire attached.
[0073] FIG. 07 is a distal [rear] view of an entire point row
assembly.
[0074] FIG. 08 is a close-up of a point row assembly, distal
side.
[0075] FIG. 09 is an array of points with alternating rows of two
materials, ferromagnetic and diamagnetic metals.
[0076] FIG. 10 is a flexible base block with mounting points.
[0077] FIG. 11 and 12 are point row assemblies in the flexible base
block--active side view and side elevation, respectively.
[0078] FIG. 13 is a unit point block assembly, exploded view, in
the preferred [portable] embodiment.
[0079] FIG. 14 and 15 show a unit point block assembly in distal
[rear, away from patient] views highlighting the alternating point
materials and the conductive strips, respectively, in the preferred
[portable] embodiment
[0080] FIG. 16 shows a 3.times.3 assembly of unit blocks, an
arbitrary array of separably controllable unit point block
assemblies--in three rows of three in this example, in the
preferred [portable] embodiment.
[0081] FIG. 17 shows a 3.times.3 unit block assembly attached to a
flexible base (e.g. a sturdy fabric) in the preferred
embodiment.
[0082] FIG. 18 is a 3.times.3 unit assembly on its base with
electrical connectors to two source modules supplying
electromagnetic stimuli through an intermediary adapter module in
the preferred embodiment.
[0083] FIG. 19 is an example of a finished operational assembly
showing accessory attachment points in its flexible base in the
preferred [portable] embodiment.
[0084] FIGS. 20 and 21 shows an operational assembly, in the
alternative [clinical] embodiment, with two attachments in an
exploded view and assembled, respectively. The visco-elastic pad
attachment is usually employed with both embodiments. Optional
accessories fit between the operational assembly and its
visco-elastic pad attachment.
[0085] FIG. 22 is an exploded view of a typical attachable
accessory, in this case providing supplementary magnetic fields by
means of permanent magnets. Access holes and gaps within the
accessory assembly make it fully compatible with both the preferred
[portable] and the alternative [clinical] embodiments of this
invention.
[0086] FIGS. 23 and 24 show plan views of an electromechanical
adapter with one and two source modules, respectively, attached to
the preferred embodiment of this invention.
[0087] FIG. 25 is a standard electromechanical 3.times.3 adapter
module with one source module.
[0088] FIG. 26 is a 3.times.3 data and real time adapter module
with a data source module, permitting simultaneous monitoring and
control of each point block separately.
[0089] FIG. 27 shows the alternative [clinical] embodiment support
block. The opening in the flexible base accommodates a mounting
fixture for accessories including hypodermic needles, topical
medicinal applicators, and sensors to monitor physical parameters
such as temperatures, or electromagnetic and galvanic,
conditions.
[0090] FIGS. 28 and 29 show an alternative embodiment unit point
block assembly in active and distal side views, respectively.
[0091] FIG. 30 is a unit point block assembly of the alternative
[clinical] embodiment in an exploded view.
DRAWING REFERENCE NUMERALS LISTED AND NAMED
[0092] 100: Point Array [0093] 102: Simple Support Block [0094]
104: Row of Points [0095] 106: Conductive Strip [0096] 108: Wire
Lead for Conductive Strip [0097] 110: Point Row Assembly [0098]
111: Point Row Assembly, partial view [close-up] [0099] 112: Points
Assembled in a Support Block [0100] 114: Ferromagnetic Metal Point
Rows [0101] 116: Diamagnetic Metal Point Rows [0102] 120: Support
Block, Preferred Embodiment [0103] 122: Support Block Mounting
Points [0104] 124: Support Block, Alternative Embodiment [0105]
126: Opening for Clinical Accessory Mount [0106] 128: Clinical
Accessory Mount [0107] 130: Unit Point Block Assembly, Preferred
Embodiment [0108] 132: Unit Point Block Assembly, Alternative
Embodiment [0109] 138: Fasteners for Combining Unit Blocks [0110]
140: 3.times.3 Unit Assembly, Preferred Embodiment [0111] 142:
3.times.3 Unit Assembly, Alternative Embodiment [0112] 144:
Fasteners [0113] 146: Flexible Base [0114] 148: Accessory
Attachment Points, Grommeted-Style [0115] 150: Clinical Accessory
Mount Access Openings, Grommeted [0116] 152: Grommets [0117] 160:
Adapter Module, Electromechanical [0118] 162: Adapter Module, Data
and Real Time [0119] 164: Electrical Connector: Adapter to Source
Module [0120] 166: Electrical Connector: Adapter to Unit Assembly
[0121] 168: Source Module, Parallel [0122] 170: Source Module,
Addressable Control [0123] 172: Operational Assembly. Dual Source
Option, Preferred Embodiment [0124] 174: Operational Assembly, Dual
Source Option, Alternative Embodiment [0125] 176: Operational
Assembly, Single Source Option, Preferred Embodiment [0126] 178:
Visco-Elastic Pad Attachment [0127] 180: Attachable Accessory
[0128] 182: Flexible Support [0129] 184: Permanent Magnet Array
[0130] 186: Gaps in Array Accommodate Attachment Access Lines
[0131] 208: Source Selector Switch [Single-Pole, Triple-Throw]
[0132] 210: Source On-Off-Option Switch [9-or-Greater Pole,
Multi-Throw] [0133] 212: Function Selector Switch
[18-or-Greater-Pole, Multi-Throw] [0134] 214: Multi-Circuit Jack
for Source Module Connections [0135] 218: Attachment Points to
Flexible Base [0136] 220: Multi-Circuit Connector Plug to Unit
Blocks [0137] 222: Metering and Status Display [0138] 224: Variable
Control [0139] 226: Input/Output Ports [0140] 228: Multi-Circuit
Analog Port
DETAILED DESCRIPTION OF THE INVENTION
[0141] The novel and non-obvious essence of this invention is an
array of points (FIG. 01) supported (FIG. 02) so as to be assembled
together in an array (FIG. 03), some or all of the points regularly
spaced approximately 3 mm to 6 mm apart. This point array is used
to provide a physical stimulus at the skin surface to the subject
under treatment. It has been observed that this novel arrangement
is unexpectedly able to induce useful responses not seen in other
forms of stimulation that have been used to induce and support
healing.
[0142] The approximately 3 to 6 mm spacing of arrayed points is key
to the device's novel and unexpected effects. If the points are too
close or too far, induced stimuli do not give rise to the results
observed in the present invention. The galvanic effects described
below are particularly dependent on the points not being set too
far apart. The modulation of magneto-electrical fields is seen to
be therapeutically effective in the spacing specified. It is
hypothesized that this spacing reflects underlying granularity in
the of the vascular and nervous systems, i.e. the first level of
organization of capillaries and nerve endings. It is further
hypothesized that the variations of stimuli at this scale-as seen
in the present invention-are related in magnitude to the scale of
biochemical and bioelectrical processes in living tissues. Finally,
it is hypothesized that this scale is consonant with the thickness
of dermal layers, the skin, sometimes referred to as "the body's
largest organ"
[0143] By using a flexible support in a planar-like array, the
points can be quite sharp and yet not break the subject's skin
because skin is elastic and properly supported point arrays,
flexing under subject pressure, distribute the pressure evenly. The
gentle, non-injurious irritation by these points, at least some of
which are set apart as specified, affects dermal structures which
have granularity at magnitudes of scale similar to the point
spacings and to the depth of electromagnetic field deformations
induced through the points.
[0144] This effect of scale is most evident with the use of metal
points so connected (FIG. 04-08) as to permit application of
electrical current or potential, enhancing therapeutic benefits in
an unexpected manner and degree, therapeutic effects comparable to
electro-acupuncture in their immediacy, intensity and benefit, even
though they are not to be confused with acupuncture itself.
[0145] The flexible support is a synthetic, rubbery "magnetophore"
material which is permanently magnetized by added ferromagnetic
ingredients, similar to refrigerator magnets. This provides
benefits of a magnetic field as a therapeutic stimulus.
[0146] Further developments incorporate the galvanic response of a
subject's skin to adjacent ferromagnetic and diamagnetic metal
points (FIG. 09,11, 13-15, 28-30) which create micro voltages and
currents when connected due to the moist, saline, conductive
character of human skin between them. This phenomenon yields
unexpected benefits to broad local regions of a subject differing
from those derived from direct stimulation by applying electric
current or fields. The inventor has discovered useful coordination
of acupuncture treatments and applications of his invention in its
passive, galvanic mode that are dramatically effective, e.g.
placing the point array in the mid-lumbar region to augment "Kidney
Meridian" tonification, and, in another type of acute illness,
lower-thoracic placement to augment healing of acute bronchial
conditions by means of classic Traditional Chinese acupuncture
techniques.
[0147] A further unexpected and novel effect of the mixed
ferromagnetic and diamagnetic points is seen in the modulation of
the magnetic field arising from the magnetophore base which varies
in relative polarity and intensity as it passes from point to
point.
[0148] One arrangement of diamagnetic (e.g., brass or copper) and
ferromagnetic (e.g., iron or steel) points, the arrangement used in
the preferred embodiment of this invention, is in alternating rows,
connected within themselves by a conductor and the rows connected
with each other by wire leads (FIG. 07, 08). Checkered and
hexagonal patterns are subjects of further inquiry for continuing
developments of the present invention.
[0149] It is hypothesized that this device marks a such novel,
enhanced effects over or alongside other electrical and magnetic
stimulation therapies because the assembled arrays of points create
both an effect of a single large field and, simultaneously, the
numerous pairs of electrode points create myriad small field
changes. The unexpected effect is dramatically enhanced
effectiveness of healing responses in a manner quite distinct from
other therapies and also capable of beneficially augmenting those
therapies. about 3 mm to 6 mm apart), show enhanced effects with
all types of points and stimuli. Higher point densities have little
or no effect ("like lying on a rug"); lower point array densities,
a la Kuznetsov's IPLIKATOR, exhibit little or no effect.
[0150] Rectangular arrangements of points are practical to assemble
but further research may uncover advantages for hexagonal or other
arrays not further described in this document.
[0151] Current research indicates that the points should be sharp,
or nearly so, to most effectively induce and modulate
electromagnetic fields. In practice this device has not caused
problems in which sharp points puncture, lacerate or abrade a
subject's skin. Transient minor discomfort, a sensation of
`roughness,` is common. Flushing, i.e. localized redness and warm
sensation characteristic of increased blood flow, accompanying and
following treatment is seen as a practical indicator of
effectiveness.
[0152] An advance in the development of this device incorporated
magnetized material into the point block supports (FIG. 02, 03,
09-15, 27-30). The combination of an array of points with a broad
magnetic field potentiates the magnetic forces much as with
electrical fields. On one hand, the point arrays create a wide
active field and on the other, they create alternating gradients of
field strength and field orientation between adjacent points.
[0153] This important combination of a magnetized support and
arrays of alternating diamagnetic and ferromagnetic metal points is
referred to as the unit point block assembly (FIG. 11-15, 28-30)
shown in the preferred embodiment of the present invention.
[0154] Assembling these unit blocks into arbitrarily larger arrays
is easily accomplished with fasteners that allow flexibility across
the whole device (FIG. 13, 16). Operational Assemblies (Ref. 172,
174, 176) incorporate these combined units with a flexible base,
wiring, connectors, and attachment points (FIG. 17-20) for power
supplies, other components, and accessory layers (FIG. 23-25).
Easily-layered accessory components (Ref. 180) such as heating
pads, and enhanced magnetic field sources can be used ad hoc (FIG.
20-22).
Description--Operational Modules
[0155] Therapeutic devices in common use apply up to 10 volts DC to
a subject. Galvanically induced micro currents and their
potentiation by the point arrays present the other extreme of
intensity useful in this device, a very wide range. Many different
forms of electrical current and electromagnetic fields are known to
be useful or possibly useful.
[0156] Accordingly, it is important to accomodate the optional use
of differing source modules (FIG. 18-21, 23-26) and the use of
none. The adapter modules in both embodiments of this invention
attach to any of the source modules (FIG. 18-21, 23-26) and to the
built-in wiring harness of the point block arrays, switching
between optional source modules and local galvanic effects in a
variety of combinations.
[0157] For safety and reliablility, all circuitry must be designed
to isolate users from any possible harmful electrical currents, and
unwanted electromagnetic frequencies. A combination of isolation
circuitry and fault-responsive circuitry is incorporated
accordingly and to be maintained at appropriate industrial,
consumer, and medical safey standards.
Description--Adapter Modules
[0158] The electromechanical adapter module (FIG. 18-21, 23-25;
Ref. 160) is electromechanical in operation and permits manual
switching of individual point block assemblies in the array between
up to two source modules, galvanically-induced currents, or open
(no current flow). Unit blocks function in parallel when connected
to a source module, including galvanically- and
environmentally-induced loads unless serialized by a suitably
configured Source Module. Blocks switched to "self" (the middle
throw of the three position switch), each has its own separate
galvanically- and environmentally-induced current.
[0159] A data and real time adapter module (FIG. 26; Ref. 162)
permits external devices to simultaneously monitor, drive or
control each point block assembly. This direct or indirect data and
control interface ennables one or multiple analog circuits through
the multi-circuit analog Port (Ref. 228) or digital data via
integrated digital controllers through input/output Ports (Ref.
226). It employs commercially-available integrated circuits,
controller boards, and operating systems. The arbitrary number of
circuits available to each point block is limited only by practical
considerations.
Description--Source Modules
[0160] Source modules (Ref. 168, 170) can function self-contained
or powered by battery, piezomechanically, or otherwise externally
powered. The source can provide current flows or static potentials.
These can be of direct or alternating polarities, continuous or
discontinuous, uninterrupted or interrupted, unmodulated, frequency
modulated, or amplitude modulated, unvaried, randomly, or regularly
varied-as possible and as suitable. Variants may be manually,
programmatically, limit, or feedback controlled and incorporate
appropriate sensors.
[0161] The parallel-circuit source modules are designed to operate
on unit blocks as proposed in the preferred and alternative
embodiments.
[0162] Addressable-control source modules (FIG. 26; Ref. 170) are
used with the data and real-time adapter modules (Ref. 162). The
circuitry of each addressable control source module communicates
with, controls or is controlled by external controllers through
input-output ports (Ref. 226), the data and real time adapter
module to source module connector (Ref. 164). Embodiments of this
invention may employ very fine degrees of control and monitoring
down to the individual point level through appropriately wired unit
assemblies.
[0163] Self-metering or externally-controlled sources can maintain
continuous or programmatically defined levels of stimuli based on
simultaneous monitoring of the point arrays themselves.
Description--Attachable Accessories
[0164] Accessory attachments (FIG. 20-22) outwardly resemble one
another except for attachments and connectors such as electrical
wires or tubes and varying thicknesses of the completed assemblies.
One or more accessories (Ref. 180) can be layered between the
operational assembly (Ref. 172, 174, 176) and the visco-elastic pad
(Ref. 178) to provide supplementary stimuli, including electrical
or magnetic fields, physical vibration, and heat or cold.
[0165] Attachment points are holes or integrated fasteners (Ref.
148) which align the layers. Grommets or other reinforcements (Ref.
152) may strengthen the attachment points.
Description of the Alternative [Clinical] Embodiment
[0166] The alternative [clinical] embodiment differs from the
preferred [portable] embodiment in one respect. Each unit block is
fitted (FIG. 27-30) with a clinical accessory mount designed to
securely hold devices such as hypodermic needles, topical
applicators, accupuncture needles, or sensors connected through a
tubing or wiring harness to external device[s]. In the case of
hypodermic or topical injectors, the external device may be
standard medical drip bags or pumps. Devices such as acupuncture
needles would be connected as needed to standard power sources now
in common use by practitioners in the field.
[0167] Accessory components of the system incorporate openings
(FIG. 20, 22; Ref. 150) allowing access to the clinical accessory
mount on each unit point block of the alternative embodiment. The
components within each accessory are arranged with gaps (FIG. 22;
Ref. 186) that permit tubing and wiring harnesses to run unimpeded
and be well-protected. Simple grommets or specially-purposed
fasteners (Ref. 150) may be used to reinforce and/or align these
openings.
Advantages
[0168] From the description above, a number of advantages of my
device become evident:
[0169] Novel and unexpected therapeutic benefits arise when point
arrays in the specified range of spacings apply physical stimuli to
areas of a subject's body, especially in flexible, planar
arrangements of ferromagnetic and diamagnetic points in magnetized
supports alone and with optional field sources as seen in the
preferred embodiment of this invention.
[0170] Because the assemblies are relatively thin, they permit
application of a wide variety of stimuli and intensities, singly or
in arbitrary combinations, through accessory attachments.
[0171] The flexible and modular design of this invention
accommodates needs for portability and simplicity of operation in
the field in the preferred embodiment. It accommodates intensive
use of invasive procedures, bulkier accessories, and complex
control systems in clinical settings in the alternative embodiment.
Finally, ongoing clinical and scientific research into phenomena
related to this invention's use and novel effectiveness are
facilitated by easy integration of monitoring, sensor, and control
systems.
[0172] This invention offers therapeutic opportunities that relate
to an unprecedented range of healing arts traditions and and
medical disciplines including allopathic medicine, physical
therapy, sports medicine, therapeutic massage, Traditional Chinese
Medicine, folkloric medicine, naturopathies, herbalism, and
others.
Operation--Preferred [Portable] Embodiment (FIG. 19, 20, 23-26)
[0173] Operation of this invention is typically by application of
the active side to a surface of a subject's body. This is commonly
achieved by first assembling (FIG. 20, 21) an operational assembly
(Ref. 172, 174, 176)--including an adapter module (Ref. 160, 162)
and one, two, or no source modules (Ref. 168, 170)--with optional
accessories (Ref. 180) and the visco-elastic pad attachment (Ref.
178). This combination is placed on a firm surface such as a
massage table. The subject then lies upon or reclines against the
active side of the device.
[0174] The point arrays and the subject's surface are deformed by
their mutual contact so as to exert a relatively uniform pressure
over the area of contact. The elasticity of human skin ensures that
even very sharp points (Ref. 100, 104, 110, 112, 114, 116, 122,
124, 130, 132) do not puncture it. Subjects report little or no
discomfort from the contact.
[0175] An adapter module (Ref. 160, 162) is required for operation
of the preferred and alternative embodiments described in this
application. The electromechanical adapter module (Ref. 160)
permits each unit block to be switched to a closed circuit
condition permitting electrical potential or current flow from
galvanic action induced by the adjacent ferromagnetic and
diamagnetic points contacting the subject's skin.
[0176] The adapter modules further allow each unit block to be
switched to one of two circuits which can be open (no current flow)
or closed by an attached parallel source module (Ref. 168). The
source modules may induce electrical currents or potentials of any
physical nature possible. They may provide simultaneous metering of
electrical conditions between the two sets of connected points in
the connected blocks, or they may allow simultaneous metering of
those conditions as responsive changes are created in the
subject.
[0177] The electromechanical adapter module (Ref. 160) has source
on-off-option switches (Ref. 210) with 9 poles and three states.
The states set the connected blocks open (no current), closed to
themselves (galvanic effects in parallel) or connected to the
source module plugged in to its connector (Ref. 214). More
elaborate versions of the electromechanical on-off-option source
switches (Ref. 210) accommodate differing combinations of effects
and metering through multiple circuits and switch states.
[0178] The data and real-time adapter module (Ref. 162) provides
digital (Ref. 226) and analog (Ref. 228) interfaces to the unit
blocks and controllers built in to the adapters themselves. With
these adapters, computer-based, algorithmic or automated controls
may be designed and built as needed for therapeutic or research
goals. Displays (Ref. 222), e.g. LED readouts, can optionally
provide direct information apart from attached computers or other
devices regarding the state[s] of elements within, attached to, or
affected by the adapter module.
[0179] Addressable control source modules (Ref. 170) may be used
with the data and real-time adapter modules (Ref. 162). The
circuitry of each addressable control source module communicates
with, controls, or is controlled by internal components, adapter
module controls or external devices. They may generate, monitor, or
modulate electromagnetic forces severally and in combination,
limited only by the granularity of the connections to the point
arrays and circuitry connecting them with those points.
[0180] Once the subject and the device have been placed in contact,
the switch settings on the adapter modules (Ref. 160, 162) are set
in accordance with the effects or monitoring desired.
[0181] Setting source selector switches (Ref. 208) on the
electromechanical adapter (Ref. 160) to the center position allows
galvanically-induced micro-currents to flow within each unit block.
Setting some number of the source selector switches to one of the
source on-off-option switches allows those blocks to be
disconnected (open circuit), their galvanically induced
micro-currents to flow in parallel as one circuit, or connected to
an attached source module. That source module can then provide some
induced effect, monitor electromagnetic conditions, or both.
[0182] Settings are revised as desired during a course of treatment
or observation.
Operation--Alternative [Clinical] Embodiment (FIG. 20, 21,
27-30)
[0183] The single difference between the preferred (portable) and
alternative (clinical) embodiments of this invention is the
incorporation of a clinical accessory mount (Ref. 128) in each unit
block. This mount securely latches the injector, applicator, or
sensor in place.
[0184] The additional step of attaching devices to the clinical
accessory mounts (Ref. 128) precedes assembly of the operational
assembly with its attachments (FIG. 20, 21). This present invention
allows for their use during the subsequent course of treatment or
observation.
CONCLUSION, RAMIFICATIONS, AND SCOPE
[0185] Accordingly, the reader will see that this invention
incorporates new and novel technologies for therapy and biomedical
research. [0186] First its use of point arrays of specified
densities offers a broad subject area, non-invasive and gentle
therapeutic stimulus that functions in novel and unexpected
properties in comparison with point arrays at lesser densities.
[0187] Further, metal points mixing ferromagnetic and diamagnetic
materials create galvanic micro current therapeutic stimuli. [0188]
Further, mixing ferromagnetic and diamagnetic materials in point
arrays greatly potentiates the effectiveness of magnetic field
stimuli. [0189] Further the point arrays similarly potentiate
applied electromagnetic stimuli in ways not observed by the single
point sources employed in other therapeutic devices. [0190]
Further, heretofore separate modes of therapy are combined in a
practical, expeditious, and unprecedented manner. [0191] Further,
the modular and extensible design is adaptable to portable field
use and to intensive clinical use. Its extensibility accommodates
heretofore unexplored subjects of quantifiable scientific research
through sensors and control systems already developed and yet to be
developed.
[0192] Embodiments not herein illustrated may incorporate more
complex and detailed circuitry to extend their functionality, For
example, the source modules, adapter modules, and the arrangement
of connections between points can each vary from embodiments that
affect all points together (in parallel) to the other extreme of
separately monitoring and controlling arbitrary groups of
individual points severally or together for forces, sensors and
controllers of arbitrary degrees of complexity. It is anticipated
that this characteristic architecture will permit research and
therapies unprecedented in their scope.
[0193] Digital technology permits active addressing, control, and
monitoring of any arbitrary groups of points, sources and
conditions, limited only by the physical construction of the point
arrays and circuitry. The element of change over time, especially
changes responsive to a subject's conditions, is another
ramification implicit in this present invention's architecture.
[0194] An alternative, simpler, embodiment of this invention, not
illustrated, is possible in which the alternating point rows in
each unit block are directly connected ("shorted"). This embodiment
would permit always-on galvanically-induced micro-current flows. An
alternative, low-cost adapter module that sets this always-on
condition in the proposed embodiments is comprised of a connector
plug closing each unit block's circuit at the jack.
[0195] Three types of accessory heat sources envisioned (not
illustrated) are (a) a convenient electrical pad connected to
household power, (b) a portable, liquid-filled, stoppered bladder
suitable for chemical reaction heating [or cooling], and (c) a
pressurized liquid system utilizing a separate heater and pump to
circulating temperature-controlled substances through a
tubes-and-bladder system. The electrical heating pad and portable
bladder types are appropriate for portable uses. Pressurized
accessory heaters are suitable in a clinical setting.
[0196] Accessory magnetic field boosters covering localized or wide
areas may utilize permanent magnets (FIG. 21) or electromagnets
driven by external power supplies.
[0197] The types of arrays of points vary within the scope of this
invention. Arrangements of points may be non-planar, non uniformly
sharp or dull, or randomized by material or location. Points may
non-parallel to each other. Points may not hold fixed positions
with respect to each other. Points may be moved separately or in
groups.
[0198] The materials of the point arrays and supports will vary as
further research uncovers phenomena of interest arising from or
responsive to differences in those materials.
[0199] Although the description above contains many specificities,
these should not be construed as limiting the scope of the
invention but as merely providing illustrations of some of the
presently preferred embodiments of this invention. For example, the
density, sharpness, type of electrical conductors or semiconductors
connecting the points, constituent materials and arrangement of the
points can assume all physically possible variations, and it is
expected that, with further research, more novel and unexpected
benefits will be discovered in other combinations of this basic
combination of elements.
[0200] Thus the scope of the invention should be determined by the
appended claims and their legal equivalents, rather than by the
examples given.
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