U.S. patent application number 12/890593 was filed with the patent office on 2011-01-20 for pulsed electromagnetic energy treatment apparatus and method.
This patent application is currently assigned to REGENESIS BIOMEDICAL, INC.. Invention is credited to Robert T. Bryant, Frank R. George, Arthur A. Loya, Mary C. Ritz.
Application Number | 20110015698 12/890593 |
Document ID | / |
Family ID | 22101038 |
Filed Date | 2011-01-20 |
United States Patent
Application |
20110015698 |
Kind Code |
A1 |
George; Frank R. ; et
al. |
January 20, 2011 |
PULSED ELECTROMAGNETIC ENERGY TREATMENT APPARATUS AND METHOD
Abstract
An apparatus and method for the treatment of chronic wounds
using electromagnetic energy. The apparatus includes a generator
and at least one applicator. The generator can produce
electromagnetic energy and the applicator can apply the
electromagnetic energy produced by the generator. A detector is
disposed on the applicator that can measure the field strength of
the electromagnetic energy applied.
Inventors: |
George; Frank R.;
(Scottsdale, AZ) ; Loya; Arthur A.; (Mesa, AZ)
; Ritz; Mary C.; (Scottsdale, AZ) ; Bryant; Robert
T.; (Tempe, AZ) |
Correspondence
Address: |
MORRISON & FOERSTER LLP
425 MARKET STREET
SAN FRANCISCO
CA
94105-2482
US
|
Assignee: |
REGENESIS BIOMEDICAL, INC.
Scottsdale
AR
|
Family ID: |
22101038 |
Appl. No.: |
12/890593 |
Filed: |
September 24, 2010 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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11344455 |
Jan 30, 2006 |
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12890593 |
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09994598 |
Nov 20, 2001 |
7024239 |
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11344455 |
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09231790 |
Jan 15, 1999 |
6334069 |
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09994598 |
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60071396 |
Jan 15, 1998 |
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Current U.S.
Class: |
607/50 ;
607/154 |
Current CPC
Class: |
A61N 1/40 20130101; A61N
1/326 20130101 |
Class at
Publication: |
607/50 ;
607/154 |
International
Class: |
A61N 1/40 20060101
A61N001/40; A61N 1/06 20060101 A61N001/06 |
Claims
1. A non-thermal electromagnetic energy wound treatment method
comprising: placing a self-supporting applicator on or adjacent to
a target wound site of an individual, wherein said applicator is
placed externally with respect to the body of said individual, and
wherein said applicator is configured to have a fixed capacitance
while delivering an RF energy treatment dosage into a target wound
site; generating a pulsed RF signal output in a generating unit
separate from the applicator; delivering said signal output from
said generating unit to said applicator via a cable, wherein said
cable connects the generating unit and the applicator; and
radiating a pulsed RF electromagnetic field treatment dosage from
said applicator into said target wound site, to promote wound
treatment, wherein radiating the pulsed RF electromagnetic field
treatment dosage occurs without manually tuning the capacitance of
the applicator.
2. The method of claim 1, wherein radiating a pulsed RF treatment
dosage comprises delivering a dose of less than about 300
mw/cm.sup.2 average RF power.
3. The method of claim 1, wherein radiating a pulsed RF treatment
dosage comprises delivering a dose of less than about 200
mw/cm.sup.2 average RF power.
4. The method of claim 1, wherein radiating a pulsed RF treatment
dosage comprises delivering a dose of less than about 100
mw/cm.sup.2 average RF power.
5. The method of claim 1, wherein radiating a pulsed RF treatment
dosage comprises delivering a dose of less than about 2 mw/cm.sup.2
average RF power.
6. The method of claim 1, wherein radiating a pulsed RF treatment
dosage comprises delivering a dose having a pulse envelope with a
pulse duration of between about 16 to about 60 microseconds and a
repetition rate of between about 600 to about 1,500 pulses per
second.
7. The method of claim 1, wherein radiating a pulsed RF treatment
dosage comprises delivering a dose having a pulse envelope with a
pulse duration of about 32 microseconds and a repetition rate of
about 1,000 pulses per second.
8. The method of claim 1, further comprising providing an input
power to generate the pulsed RF signal output, wherein the input
power is about 3 watts or less.
9. The method of claim 8, wherein providing the input power
comprises providing an input power of less than about 1 watt.
10. The method of claim 8, wherein providing an input power
comprises providing power from a battery.
11. The method of claim 1, wherein radiating a pulsed RF energy
treatment dosage into said target wound site does not require
manual adjustment of power, pulse rate duration, pulse width
duration, capacitance, or treatment time by a treatment
provider.
12. The method of claim 1, wherein delivering the signal comprises
delivering a signal having a power, pulse rate duration, and pulse
width duration that are not manually adjustable during
treatment.
13. The method of claim 1, wherein radiating a pulsed RF energy
treatment dosage into said target wound site produces a constant
and repeatable treatment dosage.
14. The method of claim 1, wherein radiating a pulsed RF energy
treatment dosage into said target wound site produces a constant
and replicable treatment dosage without manual adjustment.
15. The method of claim 1, wherein placing the applicator on the
target wound site comprises placing an applicator having a fixed
capacitance on the target wound site.
16. The method of claim 1, further comprising monitoring the pulsed
RF energy treatment dosage radiated.
17. The method of claim 16, wherein monitoring the pulsed RF energy
treatment dosage radiated comprises automatically monitoring the
pulsed RF energy treatment dosage radiated, using a field strength
sensor.
18. The method of claim 16, wherein monitoring the pulsed RF energy
treatment dosage radiated comprises automatically monitoring the
pulsed RF energy treatment dosage radiated, using multiple sensing
or detecting circuits.
19. The method of claim 18, further comprising supplying a feedback
signal to modify the pulsed high frequency signal output based on
output from the field strength sensor.
20. The method of claim 1, wherein radiating the pulsed RF
electromagnetic field treatment dosage occurs without manually
tuning the capacitance of the applicator. the pulse rate, the pulse
width, the RF power, and the treatment time during radiating the
pulsed RF electromagnetic field treatment dosage.
21. A non-thermal electromagnetic energy wound treatment method
comprising: placing a self-supporting applicator on or adjacent to
a target wound site of an individual, wherein the applicator is
placed externally with respect to the body of the individual, and
wherein said applicator is configured to have a fixed capacitance
while delivering an RF energy treatment dosage into a target wound
site; generating a pulsed RF signal output in a generating unit
separate from the applicator; delivering the signal output from the
generating unit to the applicator via a cable, wherein the cable
connects the generating unit and the applicator; radiating a pulsed
RF electromagnetic field treatment dosage from the applicator into
the target wound site, to promote wound treatment, wherein
radiating the pulsed RF electromagnetic field treatment dosage
occurs without manually tuning the capacitance of the applicator;
monitoring the pulsed RF energy treatment dosage radiated using a
field strength sensor; and modifying the pulsed high frequency
signal output based on an output from the field strength
sensor.
22. A non-thermal electromagnetic energy wound treatment method
comprising: placing a self-supporting applicator on or adjacent to
a target wound site of an individual, wherein said applicator is
placed externally with respect to the body of said individual,
wherein said applicator is configured to have a fixed capacitance
while delivering an RF energy treatment dosage into a target wound
site; generating a pulsed RF signal output in a generating unit
separate from the applicator; delivering the signal output from the
generating unit to the applicator via a cable, wherein the cable
connects the generating unit and the applicator; radiating a pulsed
RF electromagnetic field treatment dosage from the applicator into
the target wound site, to promote wound treatment, wherein
radiating the pulsed RF electromagnetic field treatment dosage
occurs without manually tuning the capacitance of the applicator;
and modifying the pulsed RF signal output based on the pulsed RF
electromagnetic treatment dosage measured at the applicator.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application is a Continuation of U.S. patent
application Ser. No. 11/344,455, filed Jan. 30, 2006, which is a
continuation application of U.S. patent application Ser. No.
09/994,598, filed on Nov. 20, 2001, which is a continuation
application of U.S. patent application Ser. No. 09/231,790, filed
on Jan. 15, 1999, issued as U.S. Pat. No. 6,334,069, which claims
priority of an earlier filed provisional application U.S. Ser. No.
60/071,396, filed on Jan. 15, 1998, the entire content of which are
incorporated herein by reference, in their entirety.
TECHNICAL FIELD OF THE INVENTION
[0002] This invention relates to electromechanical devices and
methods for therapeutically treating human body tissue, and more
particularly to a device for and a method of stimulating cell
proliferation and related molecular events using high frequency
pulsed electromagnetic energy.
BACKGROUND OF THE INVENTION
[0003] The present invention is an important advancement in the
fields of endogenous pharmacotherapeutics, electromagnetic
medicine, wound physiology and treatment, and regulation of the
cell cycle, and has specific application in the area of wound
healing, and in particular, the healing of chronic wounds, such as
pressure ulcers, diabetic ulcers and venous stasis ulcers. Prior to
discussing the present invention in detail, it is helpful to
understand the specific mechanisms of wound healing, the immediate
need for wound healing therapies, and the current state of the
art.
[0004] While the specific mechanisms of action have not been fully
determined, research over the past several years has substantially
increased understanding of the nature of wound healing and the
elegant cascade of signaling events necessary for the initiation of
cell growth and migration and tissue regeneration, which
collectively constitute the wound healing process. Importantly,
numerous biochemical mediators of cell migration patterns and
cell-cell/cell-extracellular matrix interactions involved in the
reformation of tissue/organ systems have been identified.
[0005] There are distinct phases associated with the process of
wound healing. In the inflammatory phase, platelets aggregate to
deposit granules, which promote fibrin deposition, and stimulate
the release of growth factors. Leukocytes migrate to the wound site
and begin to digest and transport debris away from the wound. It is
also during the inflammatory phase that monocytes are converted to
macrophages, which release growth factors for stimulating
angiogenesis and the production of fibroblasts. Next, in the
proliferative phase, granulation tissue forms and epithelialization
begins. Fibroblasts, key cell types in this phase, proliferate and
synthesize collagen to fill the wound and provide a strong matrix
on which epithelial cells grow. As collagen is produced by
fibroblasts, vascularization extends from nearby vessels to supply
nutrients to the regenerating tissue. The red loops of blood
vessels give the wound a granular appearance, thus the term
granulating. Epithelialization involves the migration of epithelial
cells from the wound surfaces to seal the wound. Epithelial cells
are driven by the need to contact cells of like type and are guided
by a network of fibrin strands which function as a grid over which
these cells migrate. Contractile cells called myofibroblasts appear
in wounds and aid in wound closure. These cells exhibit collagen
synthesis and contractility, and are common in granulating wounds.
In the final phase of wound healing, the differentiation or tissue
remodeling phase, collagen in the scar undergoes repeated
degradation and resynthesis. It is during this phase that the
tensile strength of the newly formed skin increases.
[0006] Clearly, growth factors are important messengers in
coordinating this complex orchestration of cellular events. Today,
growth factors refer to an expanding class of molecules, sometimes
with specificity for certain types of cells, that can have either
pro-proliferative or anti-proliferative/differentiation effects,
depending upon the specific circumstances. Their immediate
molecular targets are specific members in the superfamily of
receptor tyrosine kinases. Relatively little is known about the
regulation of growth factor activity, but spatial and temporal
gradients of growth factor and receptor expression are evident, and
expression of a given growth factor or its receptors can be induced
by other growth factors, suggesting that sequences of growth
factor-mediated messages networked across cell types and integrated
with other signaling cascades are central to tissue/organ
development, maintenance and healing processes.
[0007] Thus, the recent realization that growth factors can serve
as paracrine, autocrine, juxtacrine and intracrine (which refers to
actions of growth factors within a cell) signals to regulate
proliferation, migration, and interaction of cells critical to
wound healing is important to understanding and developing wound
treatments. For example, central to tissue/organ repair and
remodeling is the critical revascularization of damaged tissue.
Vascular endothelial growth factor (VEGF) is a recently discovered
agent that promotes proliferation and migration of endothelial
cells. Stimulating the expression of VEGF receptors in endothelial
cell precursors allows those cells to respond to VEGF secreted from
other cells or to VEGF acting via autocrine/intracrine mechanisms.
Stimulating the release of VEGF from fibroblasts and/or other cell
types (or stimulating VEGF production in endothelial cells)
promotes mitotic and/or migratory activity of endothelial cells.
Also critical to tissue repair is establishment of the
extracellular scaffold to support cell migration and/or
proliferation. Stimulating the release of agents such as fibroblast
growth factors (FGF) from any of a number of cell types promotes
proliferation and migration of fibroblasts, which are involved in
production of extracellular matrix materials such as collagen.
Moreover, stimulating FGF receptor production in fibroblasts
capable of recognizing paracrine, autocrine, or intracrine FGF also
plays a role in stimulating fibroblast activity and the production
of extracellular matrix. Other agents implicated in tissue repair
include insulin-like, platelet, transforming, and epidermal growth
factors. Those molecules and their receptors are the likely
molecular substrates for tissue repair. Endothelial cells,
fibroblasts and keratinocytes, among others, are the cell types
whose activity is critical to tissue repair and represent the
likely cellular targets for these growth factors and related
molecules associated with the healing of pressure sores.
[0008] It is also well known that regulatory signals normally found
in the repair of acute wounds are not present in chronic wounds
such as pressure ulcers and venous stasis ulcers. For example,
chronic wounds frequently have poorly vascularized, thick fibrotic
scar tissue surrounding the wound bed, are characterized by
keratinocytes incapable of proliferation and migration, and have
few active fibroblasts. These occurrences are clearly indicative of
defects in growth factor signaling.
[0009] With the understanding that defects in growth factor
signaling contribute to the development and/or persistence of
chronic wounds, it is logical to conclude that reinstitution or
normalization of that signaling would promote wound healing. Growth
factors have been considered candidate therapeutics for wound
healing because they are synthesized by and stimulate cells
required for tissue repair, they are deficient in chronic wounds,
and there is some evidence that pharmacological application
enhances wound repair in a variety of animal models of dermal
incisional and excisional repair.
[0010] However, clinical studies have been disappointing and some
experts have suggested that an alternative to single growth factors
as therapeutic agents is the utilization of growth factors in
combination to elicit synergistic clinical efficacy. This lack of
therapeutic efficacy may be in part because wound healing is a
complex programmed sequence of cellular and molecular events,
including macrophage activation during inflammation, cell
migration, angiogenesis, provisional matrix synthesis, synthesis of
collagen by fibroblasts, and reepithelialization. Current
pharmaceutical approaches do not fully mimic the necessary spatial
and temporal patterns of growth factor activity needed to promote
wound healing. Overall, the complexity and variability of clinical
wounds have limited pharmacological approaches to accelerate wound
healing, leaving dressings and nonpharmacological ancillary
modalities to dominate the market associated with wound
management.
[0011] A treatment regimen involving application of outside or
exogenous growth factors and other medicinal agents to the wound
site is but one approach that has been pursued in the treatment of
wound healing. Various medical treatment devices utilizing physical
energy emissions to stimulate wound healing have also been
developed over the past 40-50 years. Most of these devices involve
the use of applied electrical currents to stimulate growth in bone
or soft tissue. Another major group of devices utilizes the passage
of electrical currents through coils of wire to create magnetic
fields which are applied either by placing the coil in proximity to
the human body or by wrapping the coils around the body or limb.
Finally, a number of devices have been developed which utilize an
antenna or tank circuit to apply Radio Frequency (RF)
electromagnetic energy to the body for the purposes of medical
treatment. Most devices in this latter category utilize continuous
energy output to create thermal energy within the tissue. However,
a subcategory of these devices utilize pulsed electromagnetic
energy output to theoretically stimulate tissue without inducing a
thermal response, although this has never been completely proven to
occur using existing devices. There have been observations that
some of these devices appear to stimulate or accelerate the wound
healing process but there has been no sound, scientific data
offered to explain how such devices might work at the cellular or
molecular levels.
[0012] One area in which health care professionals and insurance
providers are demanding improved treatment regimes is in the
treatment of chronic wounds. In the United States, where wound care
constitutes less than 1% of aggregate health care dollars, treating
and managing pressure ulcers requires an inordinate amount of
material, human resources, time and money. The costs associated
with managing just one type of chronic wound alone, pressure
ulcers, are extraordinary.
[0013] To enhance quality and decrease the cost of health care, the
Agency for Health Care Policy and Research (AHCPR) was established
by the U.S. government in 1989. That agency published Clinical
Practice Guidelines for both prevention and treatment of pressure
ulcers in 1992 and 1994, respectively. The release of these
guidelines substantially increased biomedical awareness of patients
with pressure ulcers, including the elderly and those afflicted
with various spinal and neurological disorders. Importantly, the
Health Care Financing Administration (HCFA) utilizes these
guidelines to create medical policy and reimbursement criteria.
Electrotherapeutic modalities are the only type of adjunctive
therapy recommended in the AHCPR Clinical Practice Guideline and
supported by the Nation Pressure Ulcer Advisory Panel.
[0014] Electrotherapy includes various means for applying an
electric or electromagnetic field to a wound area to facilitate
growth and proliferation of new tissue, i.e., healing. Application
of external electrical and electromagnetic fields is now an
increasingly standard therapy for the treatment of nonunion bone
fractures, but these devices have seen limited use in other areas
of healing.
[0015] Clinical research has shown that treatment with electrical
stimulation or electromagnetic fields can enhance the healing rate
of pressure ulcers unresponsive to conventional therapy. For
example, pulsed electrical stimulation has been shown to enhance
the healing rate of decubitus ulcers. This therapeutic approach
stems from observations for nearly 60 years that electric
potentials over wounds are negative until healed, and the related
hypothesis that living tissues possess direct current surface
potentials that regulate the proliferative phase of healing and
that healing can be induced by negative electrical potential.
Unfortunately, this has led to unsubstantiated claims that
electrical stimulation cures a wide variety of health problems,
thereby alienating the medical profession. Though this idea is now
archaic and simplistic in view of scientific studies of the
cellular correlates of wound healing, the evidence suggests that
electrical fields accelerate wound healing. While few well designed
experiments concerning cellular mechanisms have been conducted,
some published reports indicate that electrical stimulation
activates macrophages and increases cell proliferation, collagen
synthesis and the expression of fibroblast receptors for
transforming growth factor-beta.
[0016] Treatment devices emitting magnetic and/or electromagnetic
energy offer significant advantages over other types of electrical
stimulators because magnetic and electromagnetic energy can be
applied externally through clothing and wound dressings, thereby
rendering such treatments completely non-invasive. Moreover,
published reports of double blind placebo-controlled clinical
trials utilizing a RF transmission device (Diapulse) suggest that
this ancillary treatment device significantly reduces wound healing
time for chronic pressure ulcers as well as for surgical wounds.
Studies using Dermagen, a magnetic device manufactured in Europe
which produces a low frequency magnetic field, have demonstrated
significant augmentation of healing of venous stasis ulcers.
Additionally, it has been shown that 50% fewer patients treated
with electromagnetic energy develop reoccurring pressure ulcers,
compared to control patients, suggesting that electromagnetic
energy treatments impart some resistance to the reoccurrence of
chronic wounds, such as pressure ulcers. Electromagnetic energy may
also be useful as a preventative strategy. Perhaps most important
from a practical clinical perspective, an actuarial analysis of the
effects of electromagnetic energy on the treatment of pressure
ulcers show that this treatment, by reducing healing time by an
average of 50%, results in significant reductions in the costs
associated with wound management.
[0017] One category of prior art magnetic/electromagnetic treatment
devices utilizes the passage of electrical currents through coils
of wire to create magnetic fields. The frequency of the electrical
impulses is relatively low, typically in the low frequency or audio
range. Other devices, which utilize electrical stimulation between
electrodes, represent a substantially different approach to medical
treatment from the present invention for the primary reason that
such an approach is invasive and more difficult to use and involves
the attachment of electrodes at or near the wound site.
[0018] Another category of prior art electromagnetic treatment
apparatus includes high frequency, high power devices utilizing
pulsed electromagnetic energy output to stimulate tissue without
inducing a thermal response. This category of devices is
represented by the inventions disclosed in the following U.S. Pat.
Nos.: Milinowski, 3,043,310 and 3,181,535; Kendall 3,543,762; Pearo
3,670,737; and most recently Rauch et. al., 5,584,863. Those
earlier inventions first described and defined the principle and
operation of pulsed, high frequency energy output devices and/or
systems.
[0019] While numerous high frequency devices using pulsed
electromagnetic energy to stimulate tissue growth have been
developed, none have effectively addressed the needs of patients
and health care providers. A recent attempt, as described in U.S.
Pat. No. 5,584,863, is a pulsed radio frequency electrotherapeutic
system having a pulse generator and an athermapeutic applicator
head. The generator includes a power supply electrically connected
to a remote current source by a cord, an exciter for generating
pulsed signals of a selectable megahertz frequency, and an
amplifier for amplifying the pulsed signals. A system controller
having manually operable dials is provided for controlling pulse
width duration, pulse burst repetition rate and power amplitude of
the pulsed signals generated by the exciter. The amplitude of the
signals outputted from the amplifier are compared with a reference
value using a standing wave ratio (SWR) detector circuit, which in
turn outputs power and impedance compensated signals to the
applicator and produces a ratio signal that is delivered to the
controller for adjusting the amplitude and phase of the signals
generated by the exciter. The applicator, which includes a pair of
spaced capacitor plates, a magnetic coil wound in a plane parallel
to and electrically connected to the plates, and an RF shield,
induces the received compensated signals into the tissue to be
treated. Reactance and power level of the output of the applicator
are manually controlled using an external tuning means connected to
one of the capacitors. The device disclosed in U.S. Pat. No.
5,584,863 has high power requirements, requires numerous manual
adjustments for effective operation, incorporates only a single
applicator, fails to ensure constant, known and replicable
treatment dosage outputs, and provides no confirmation that the
applicator is properly located during treatment.
[0020] While the various and several prior art inventions, as
described in the above referenced patents, produce electrical,
magnetic or electromagnetic fields for treatment of tissue,
virtually none of the prior art describes any credible cellular or
physiological or molecular processes by which such energy fields
specifically alter, induce or otherwise make happen an increase in
cell growth, proliferation or density.
[0021] Additionally, none of the previous high frequency, high
power devices utilizing pulsed electromagnetic energy output
adequately addresses such practical design concerns as ease of use,
simultaneous treatment of multiple wound sites on the same patient,
dosage measurement, monitored dosage control and/or dosage
compliance.
[0022] It would be desirable therefore to provide a method of and
an apparatus for treating wounds with high frequency pulsed
electromagnetic energy that is easy to implement, requiring minimal
training in its proper and effective use, assures a constant, known
and replicable dosage output, provides for simultaneous treatment
of multiple wound sites, has low power requirements and is cost
effective.
[0023] Citation of the above documents, devices and studies is not
intended as an admission that any of the foregoing is pertinent
prior art. All statements as to the date or representation as to
the contents of these documents is based on the information
available to the applicants and does not constitute any admission
as to the correctness of the dates or contents of these documents.
Further, all documents referred to throughout this application are
incorporated in their entirety by reference herein.
SUMMARY OF THE INVENTION
[0024] In view of the foregoing limitations and shortcomings of the
prior art, as well as other disadvantages not specifically
mentioned above, it should be apparent that there still exists a
need in the art for improved electromagnetic energy treatment
apparatus and methods. It is therefore a primary object of the
present invention to fulfill that need by providing a method of and
apparatus for the treatment of chronic wounds using pulsed
electromagnetic energy that is cost effective, easy to implement,
and ensures proper treatment dosage delivery without the need for
manual adjustment of power, pulse rate duration, pulse width
duration, treatment time or reactance by the treatment
provider.
[0025] More particularly, it is an object of this invention to
provide an electromagnetic energy treatment apparatus with the
ability to produce a constant, known and replicable treatment
dosage output that is not adversely affected (i.e., does not negate
consistent dosage or efficacy) by the proximity of the body of the
patient (e.g., capacitance, inductance).
[0026] It is yet another object of this invention to provide an
electromagnetic energy treatment apparatus wherein one or more
wound sites may be simultaneously treated with different treatment
dosages.
[0027] It is still another object of this invention to provide an
electromagnetic energy treatment apparatus wherein the applicator
is easily and accurately positioned directly on or adjacent to the
wound site regardless of where the site is located on the
patient.
[0028] Still another object of this invention is to provide an
electromagnetic energy treatment apparatus wherein the applicator
includes printed coils formed on one or more printed circuit
boards, with the primary coil and secondary coil forming a matching
network for effecting a highly efficient RF output. In other words,
the applicator includes closely matched and tuned primary/secondary
circuits, which greatly enhances efficiency by allowing the use of
reduced power levels.
[0029] It is a yet further object of this invention to provide an
electromagnetic energy treatment apparatus having the ability to
affect living tissue by providing an accurate treatment dosage of 1
to 300 mw/cm.sup.2 with very low input power requirements (i.e., an
average power requirement in the range of less than three watts,
and preferably less than about one watt).
[0030] It is a still further object of this invention to provide an
electromagnetic energy treatment apparatus wherein treatment
dosages are automatically monitored for safety by multiple sensing
or detecting circuits and controlled by a field strength
sensor.
[0031] It is a yet further object of this invention to provide an
electromagnetic energy treatment apparatus that is small, portable,
easy to use and safe to operate, with the apparatus automatically
maintaining the appropriate treatment dosage and shutting down when
certain conditions are present.
[0032] Briefly described, the present invention is an improved
method of and apparatus for generating and administering treatment
dosages of pulsed electromagnetic energy for wound healing
applications. Specifically, the present invention generates and
applies constant, known and replicable treatment dosages of
electromagnetic energy of defined specifications to the human body
for the purposes of inducing cell proliferation. In its preferred
form, the present invention includes a pulsed electromagnetic
energy generator, control means, including a power level controller
responsive to signals from multiple sensing and control circuits,
and one or more interchangeable treatment pad applicators. The
generator, which can be battery-operated, is a low power, compact
unit whose output is controlled by the multiple sensing and control
circuits via the power level controller. The control circuits
include integral sensing circuits for ensuring specified treatment
dosage and the safety and effectiveness of the apparatus as a
medical instrument, and one or more detectors located in or on each
applicator for sensing energy output at the site of application and
monitoring, with precision, the treatment dosage. Other circuits
are included for disabling the apparatus when certain conditions,
such as insufficient power, exist.
[0033] The generator of the present invention has multiple
treatment ports to which one or more applicators are attached via
cables to provide for the simultaneous treatment of one or more
wound sites on the same patient. Preferably, the apparatus allows
the applicators to operate independently and simultaneously at
different treatment dosage levels. The applicators are treatment
pads of various sizes comprising tuned tank circuits and a field
strength sensor to allow for automatic control of the output
specifications of the apparatus. Each applicator also has detectors
for sensing proximity to the patient during the course of treatment
and informing the patient if the applicator inadvertently moves
from its intended treatment position.
[0034] The present invention has numerous advantages not found in
existing electromagnetic energy treatment apparatus. First, the
generator of the present invention is operationally efficient and
has low power requirements, on the range of less than three watts
of average power (preferably less than one watt). This allows the
unit to be battery operated and greatly reduced in size, thereby
rendering the apparatus portable and easy to use, as the small size
facilitates transport and placement of the unit, with minimal
disruption, in the patient's treatment area during use.
[0035] Another advantage of the present invention relates to its
integration of multiple sensor and control circuits which, for the
first time, ensures precise treatment dosage and provides
confirmation that the applicator remains on the wound site during
the entire course of treatment. In addition, these sensor and
control circuits allow for unattended operation of the device
during treatment, providing for a highly simplified means of
treatment. The multiple monitoring and control circuits are
separate and distinct, and include a fixed period treatment timer,
forward and reflected power monitor circuits (one for each
treatment port provided by the generator), an electromagnetic
energy signal strength detector and controller circuit, and a
treatment pad to patient proximity detector. Together, those
control means guarantee that the correct treatment dosage reaches
the patient.
[0036] Another advantage of the present invention not found in
existing electromagnetic treatment devices is the multiple port
generator for allowing the simultaneous use of multiple
applicators. When using existing electromagnetic treatment devices,
caregivers are limited to the treatment of just one wound site per
each time interval of unit use. Because many pressure sore patients
have two or more wounds, the present invention greatly reduces
treatment time and expense since multiple wounds can be treated at
once. Preferably, each treatment applicator is selected to operate
simultaneously at a different treatment dosage level to accommodate
multiple wound sites.
[0037] Each treatment applicator of the present invention also
includes novel elements which overcome several major deficiencies
in previous designs. Existing applicators are typically large
volume, rigid extensions of the power sources. The applicator of
the present invention is substantially reduced in size, bulk and
power requirements. This is possible, in part, due to the
utilization of low power and the increased operational efficiency
of the generator and applicator itself. Preferably, each applicator
is thin, flexible and constructed in any of a wide variety of
shapes and sizes to accommodate various wound sites. In one
embodiment, the treatment pad is configured as a rectangle with
dimensions of approximately 10 inches by 5 inches and a nominal
thickness of less than 1/2 inch. Each applicator is a flexible pad
comprising one or more etched copper printed circuits laminated
between insulating sheets of flexible material having high
dielectric properties. The two circuits operate as an impedance
matching transformer. Sensing units, including an electromagnetic
signal strength detector and an applicator-to-patient proximity
detector, are incorporated in each applicator and are in
communication with the power level controller to provide for direct
monitoring of the electromagnetic energy field and precise control
of the treatment dosage. By modifying the topology of the etched
printed circuit inductor portion of the LC circuit and then
correspondingly adjusting the capacitance value of the capacitor to
retune the LC circuit to resonance, the applicator can be
constructed in a variety of shapes and sizes to best match the
wound size and area on the patient. Moreover, the tank circuit in
the applicator is pre-tuned, thereby eliminating the need to
manually tune the circuit as it comes into close proximity with the
human body or other objects. Given its nominal thickness and
increased flexibility, the applicator can be placed over, under or
around a bandaged wound site.
[0038] Other novel and unique features of the applicator include
the following. Existing electromagnetic energy devices do not
include mechanisms for delivering precise and replicable treatment
dosages to the patient. Although previous designs may have
specified that the applicator be tuned to resonance or may have
included a mechanism for matching the generator and the applicator
in order to minimize SWR, there has been no way to ensure that
accurate treatment dosage was being delivered through the coils
located in the applicator and beyond, to the surface of the
patient's wound site. In the present invention, a signal detector,
such as a germanium diode signal detector, is included as part of
the applicator for measuring the energy emission from the
applicator and supplying a feedback signal to the RF amplifier for
controlling energy output. The actual electromagnetic energy field,
or treatment dosage, that is transmitted from each applicator is
measured directly by embedding the RF signal strength detector
inside of the applicator. The signal level from the detector is
sent to the power level controller, where it is used as a
feedback-control signal to control the output of the RF amplifier
of the generator. This direct approach to measuring the actual
radiated electromagnetic energy field is a much more precise way to
measure the treatment dosage, rather than by indirectly measuring
the SWR of the transmitted RF signal. If, at any time, the detector
measures a radiated energy output level above or below preset
levels, an indicator, such as a "service required" lamp or alarm,
audibly, visually or otherwise informs the health care provider and
patient of the occurrence and the power level controller switches
off the RF amplifier. The forward and reflected power measuring
circuits are used to turn the unit off only if either circuit
exceeds preset limits. In this manner, the present invention
monitors energy emissions from each applicator and ensures that the
treatment dosage delivered through each applicator is precise.
[0039] The applicator of the present invention is thin and need not
be suspended on a mechanical arm, as required by some existing
applicators. Because of the unique configuration of the present
invention, a correct treatment dosage is easily and effectively
delivered to the patient.
[0040] The present invention further includes a method of
effectively treating chronic wounds such as pressure ulcers
involving the precise induction of specific biochemical events
associated with cell proliferation. In accordance with the present
invention, an electromagnetic field of specified strength and
duration is used to stimulate cellular growth and proliferation,
membrane ionic flux, growth factor expression, release and
functional enhancement, and reductions in cell doubling time.
Electromagnetic energy fields are utilized to stimulate and
accelerate cell growth and proliferation upon certain types of
cells known to be critical to the wound healing process, including
fibroblasts and epithelial cells. Electromagnetic stimuli induce
cell proliferation by reducing the G.sub.o and/or G.sub.1 phases of
the cell cycle, by stimulating the genetic expression, release and
functional enhancement of growth factors, and by inducing the flux
of ions across cellular membranes. Therefore, the present invention
acts as a mitogen and/or a positive modifier of cellular mitogenic
activity. This mitogenic effect results in growth factor
stimulation, expression and release, both intra-and
extracellularly. A key component of the present method is the
specific enhanced actions of fibroblast growth factors.
[0041] It is important to note that the present method, which
utilizes electromagnetic energy as a stimulus for inducing cell
proliferation through mechanisms regulating decreases in cell cycle
time, is independent of the particular source of the energy
emission or the design of the energy source. The term
electromagnetic energy includes effects from its magnetic energy
and/or electrical energy components.
[0042] The present method utilizes electromagnetic energy as a
mitogenic stimulus to reduce cell cycle time through the
expression, synthesis and enhanced activity of growth factors,
thereby increasing the overall rate of growth and proliferation in
various biological cell types, including those found in epithelial,
muscle, connective and neuronal tissues. Energy waves which are
primarily defined as Radio Wave frequencies are used to induce
biological cell proliferation in vitro under laboratory conditions
and in vivo under clinical conditions in intact living organisms.
In the electromagnetic spectrum, those frequencies range from 1000
Hertz to 1000 Megahertz, and therefore also include a portion of
the audio frequencies (at the lower end) and range through ultra
high frequencies (UHF). The present method delivers an
electromagnetic treatment energy of 1 to 300 milliwatts per
cm.sup.2 to living tissues (in vivo or in vitro). Because it is a
specific cellular mitogen, the present method reduces cell cycle
time through the induction of specific cellular mechanisms which
reduce the duration of the separate and/or combined G.sub.o and
G.sub.1 phases of the cell cycle. Specific mitogenic physical
energy signals are provided that induce cell growth and
proliferation in part through the induction of ion flux across
cellular membranes and subsequent cellular signaling events,
including the expression, synthesis and enhanced activity growth
factors, especially fibroblast growth factors. An electromagnetic
energy stimulus is utilized to activate intracellular and
intercellular mechanisms associated with the genetic expression,
synthesis and release of biological molecules necessary to regulate
cell cycle time.
[0043] Because the present method is based upon discoveries
pertaining to the effects of specific doses of electromagnetic
energy on in vivo and in vitro cells and tissues, the present
method offers the significant advantage of fixed power output,
pulse rate and pulse width to specifically increase cell growth and
proliferation in distinct cell types found in soft tissue,
connective tissue, and neuronal cells. Treatments applied using the
present method are characterized by specific optimal dosages of
pulsed electromagnetic energy to induce cell proliferation of
specific cell types. The present method allows utilization of a
fixed pulse rate, a fixed pulse width and a fixed energy field
strength to define and produce the optimal energy specifications to
be used to stimulate specific cell types related to specific
medical indications or specific treatment regimens. It also
provides for the creation and application of specific dosages and
treatment regimens which are required for specific medical
indications. Further, the present method can also be implemented to
treat wounds other than ulcers, including burns, physical
rehabilitation, and neuronal injury.
[0044] The present invention has immediate commercial market
potential in the treatment of chronic wounds. Beyond that immediate
market, the present invention may also be utilized in other
treatment areas where increasing the rate of growth and
proliferation of human or other living cells is essential,
including the treatment of burns and surgically implanted skin or
soft tissue grafts, rehabilitation medicine, post surgical repair,
and neuronal/brain/spinal injury repair and regeneration. In
addition to the medical treatment of soft tissue, the present
method has applications in the field of laboratory
growth/manufacturing of skin grafts to be sold and used in various
surgical settings, veterinary medicine and related fields.
[0045] These and further and other objects and features of the
invention are apparent in the disclosure, which includes the above
and ongoing written specification, with the drawings.
BRIEF DESCRIPTION OF THE DRAWINGS
[0046] FIG. 1 is a block diagram of the generating unit and
applicator components of the treatment apparatus of present
invention;
[0047] FIG. 2 is a detailed block diagram of the apparatus of FIG.
1;
[0048] FIG. 3 is a block diagram of the pulse rate generator and
treatment energy pulse controller located in the generating unit of
FIG. 1;
[0049] FIG. 4 is a block diagram of the treatment timer located in
the generating of FIG. 1;
[0050] FIG. 5 is a block diagram of the power level controller
located in the generating unit of FIG. 1;
[0051] FIG. 6 is a schematic of one embodiment of the circuit for
controlling the output of the pulse generator;
[0052] FIG. 7 is a block diagram of one embodiment of the
generating unit of FIG. 1 having circuits for separately
controlling multiple applicators;
[0053] FIG. 8 is a block diagram of the isolated power supply
assembly for the treatment apparatus of FIG. 1;
[0054] FIG. 9 is a plan view of one embodiment of the applicator of
the apparatus of FIG. 1;
[0055] FIG. 10 is a front view of the applicator of FIG. 9;
[0056] FIG. 11 is a cross-sectional detail A of the applicator of
FIG. 10;
[0057] FIG. 12 is a plan view of another embodiment of the
applicator of the apparatus of FIG. 1; and
[0058] FIG. 13 is a bottom view of the applicator of FIG. 12.
DETAILED DESCRIPTION OF THE INVENTION
[0059] Referring now to the drawings, where like elements are
designated by like reference numerals throughout, FIG. 1 shows an
apparatus 10, more fully described below, for treating wounds with
electromagnetic energy. Apparatus 10 includes an electromagnetic
energy generating unit 12 with multiple ports 13, and multiple
applicators 14 connected to unit 12 by coaxial cables 16. A power
source 18, such as a battery pack, is provided for delivering a
current input to unit 12. While shown in FIG. 1 as a remote unit,
battery pack 18 can be incorporated as part of unit 12. Since the
present invention has low power requirements, the power source can
be one capable of providing an average power input of less than
three watts.
[0060] Referring to the block diagram of FIG. 2, unit 12 includes a
generator 30 for producing a pulsed high frequency signal output 32
and at least one applicator 14 having output 32 as its input.
Generator 30 includes a pulse generator 34 and one or more
amplifiers 36 having as their inputs a pulsed signal output 38 from
the pulse generator 34. The number of amplifiers 14 is preferably
equal to the number of treatment ports, such that each applicator
14 has an input from a single amplifier 36.
[0061] Treatment energy pulse controller 40 is connected to pulse
generator 34 for automatically controlling characteristics of
output 38 such as pulse rate and pulse width. Output 38 is
delivered to amplifiers 36, each of which is individually
responsive to signals 42, 42i, 42ii generated by power level
controller 44. Control signals 42, 42i, 42ii from the power level
controller 44 reflect feedback information 54 from the field
strength detector positioned on each applicator 14. One or more
control circuits, including the forward and reflected power
measuring circuits 46, the treatment timer 48 and the treatment
energy pulse controller 40, detect abnormal conditions and disable
operation when appropriate. The power level controller 44 is also
responsive to control signals 50 generated by control circuitry in
the power supply assembly 52 and control signals 56 received from
one or more proximity detectors located on the applicators 14.
Treatment timer 48, which delivers activation signals 58, 60 to the
power level controller 44 and the treatment energy pulse controller
40, respectively, for instituting the treatment process over a
predetermined period of time, is also responsive to shut down
signals 62 from the power level controller 44 for disabling the
apparatus 10 when certain conditions are detected.
[0062] The embodiment of the unit shown in FIGS. 1 and 2 has three
treatment ports 13 for simultaneously and independently delivering
different output signals 32 to three separate applicators 14. It
should be understood that the number of ports 13, amplifiers 36 and
measuring circuits 46 may be varied without departing from the
scope of the present invention.
[0063] The apparatus shown in FIG. 2 operates as follows. Signals
58, 60 from treatment timer 48 enable the power level controller 44
and the treatment energy pulse controller 40, respectively, thereby
enabling the pulse generator 34 to produce pulsed signal output 38.
Controller 44 automatically controls specific characteristics of
the pulsed signal output 38 produced by generator 38 and received
by amplifiers 36, including pulse rate, pulse width and pulse power
level. The pulsed signal output 38 is thus amplified in accordance
with instructions received from the power level controller 44, and
specific outputs 32 are produced. Each of the outputs 32 may be
different, depending on the specific instructions delivered to each
amplifier 36 by controller 44. Outputs 32 from each amplifier 36
are evaluated by forward and reflected power measuring circuits 46
and delivered to applicators 14 which, in turn, use the output to
apply a treatment dosage of electromagnetic energy to the
patient.
[0064] The power level controller 44 individually instructs each
amplifier 36 in accordance with specific information received from
the field strength detectors located on the applicators 14. As
described in greater detail below, power level controller 44, in
conjunction with multiple control circuits, also provides for
automatic disablement of the apparatus when treatment is complete,
when treatment dosages are at unacceptable levels, or when
inadequate power is being delivered to the apparatus. For multiple
applicator embodiments, unit 12 may include a single controller 44
with multiple circuits, each dedicated to a single amplifier 36,
for controlling multiple applicators 14, or multiple separate and
distinct controllers 44, each having a single circuit for
controlling a single applicator 14.
[0065] FIG. 3 is a block diagram of the pulse rate generator 34 and
treatment energy pulse controller 40 shown in FIG. 2. Generator 34
includes three major subcircuits. The first subcircuit is a pulse
rate timer 64 for generating a controlled frequency of occurrence
of the pulse envelope. Timer 64 sets the period, or pulse rate, of
treatment dosage. The output of timer 64 is sent to a second
subcircuit, the pulse width timer 66, which produces a single
consistently shaped pulse envelope. The output of timer 66 is then
used as an enable pulse for the gated high frequency RF oscillator
70 of the pulse generator 34. Oscillator 70 generates electrical
signals reflecting the characteristics defined by the enabling
pulse. The generated electrical signal output 38 is then delivered
to amplifiers 36 which increase the size or amplitude of the
signals in response to instructions received from the power level
controller 44.
[0066] For specific wound treatments, it has been demonstrated that
maximum effectiveness results when the RF pulse rate, RF pulse
width, and peak RF power level of the enable pulse are set at
specific values. For example, the ED.sub.50 dose for optimum
stimulation of human and other mammalian fibroblasts is about 15
mw/cm.sup.2 average RF power, with an ED.sub.99 of about 32
mw/cm.sup.2, while the ED.sub.99 for epithelial cells is about 100
mw/cm.sup.2. These dosages are based upon pulse envelopes with an
optimum pulse duration of about 32 microseconds and a repetition
rate of about 1,000 pulses per second. For example, in one
embodiment particularly effective in treating pressure ulcers,
timer 64 is set at between about 1,200-1,500 pulses per second, and
timer 66 is set at between about 16-20 microseconds, giving an
output of between about 30-40 mw/cm.sup.2 average power. In another
effective embodiment, timer 64 is set at between about 900-1,200
pulses per second, and timer 66 is set at between about 30-45
microseconds, giving an output of between about 30-65 mw/cm.sup.2
average power. In another effective embodiment, timer 64 is set at
between about 600-1,000 pulses per second, and timer 66 is set at
between about 32-60 microseconds, giving an output of between about
30-100 mw/cm.sup.2 average power. Other treatment profiles are
possible and can be used without departing from the scope of the
present invention.
[0067] Referring once again to FIG. 3, automatic control of
operating parameters (e.g., pulse rate, pulse width, RF power
level, treatment time, etc.) is managed by a treatment energy pulse
shaper and pulse repetition controller circuit 40. Circuit 40
includes a custom control logic circuit 72 having numerous
treatment profiles preset therein. A treatment mode selector
control 74 permits the operator to quickly select one of the stored
profiles. Pulse control circuit 76 receives the signal from circuit
72 reflecting the desired pulse rate for the selected profile and
sets the pulse rate timer 64 accordingly. Similarly, width control
circuit 78 receives the signal from circuit 72 reflecting the
desired pulse width for the selected profile and sets the pulse
width timer 66 accordingly. Further, an RF power level is selected
by the control logic circuit 72 and an appropriate signal
reflecting that selection is sent to the power level controller 44,
shown in FIGS. 2 and 5.
[0068] The ability to easily select and automatically control
operating parameters (e.g., pulse rate, pulse width, and RF power
level) is a very important feature lacking in previous devices. By
employing a control logic circuit 72, a plurality of treatment RF
pulse profiles (combination of specific RF pulse rates, RF pulse
widths, and RF power level) can be easily preset during assembly
and manufacture.
[0069] Treatment mode selector control 74 is included to allow the
operator to easily select the appropriate treatment profile. In one
embodiment, control 74 is a rotory selector witch. Preferably, the
positions are clearly labelled as to their function. In another
embodiment, control 74 is a touch pad or series of depressible
buttons or keys for electronically or otherwise inputting a
selection. It is understood that any means for selecting one or
more of a number of stored profiles is contemplated by the present
invention. In preferred embodiments, the only operator control
besides control 74 is the Start/Stop button 80 (FIG. 4).
[0070] In one embodiment of the present invention, the control
logic circuit 72 is preset with a single treatment profile. In that
embodiment, the actuating means (e.g., start/stop button 80) is all
that is required to select and start treatment.
[0071] Where multiple applicators are used, the unit 12 is provided
with multiple treatment selector controls 74, one for each
applicator 14. It is possible, however, to combine those controls
in a single structure (e.g., a touch pad).
[0072] FIG. 4 is a block diagram of treatment timer 48. To regulate
the amount of time, or treatment dosage, that a patient is
receiving the applied pulsed RF energy, a digitally controlled
treatment timer 48 is provided. The treatment timer 48 is started
by pressing an actuator 80, such as a start/stop push-button, and
is stopped by the operator by again pressing the actuator 80.
Pressing actuator 80 sets digital latch 82. Setting the digital
latch 82 starts several actions. First, a signal is sent to the
treatment energy pulse controller 40 to enable its operation.
Second, a signal is sent to the power level controller 44 to enable
its operation. Third, setting the digital latch 82 enables a time
base oscillator 84. The output of oscillator 84 is sent to a
multiple stage binary counter 86, which at its last output stage,
produces an extended square wave pulse after a fixed period of
time. This square wave pulse is then sent to a timer control 88,
producing exclusive output signals. Timer counter 88 is preset to a
predetermined treatment time, automatically controlled by logic
circuit 72, or set by the operator using the treatment selector
control 74. When the timer control 88 counts down to a value of
zero, an end of treatment output pulse is initiated and this pulse
is then used to reset the digital latch 82, disable the time base
oscillator 84, and disable the control logic circuit 72. While the
timer control 88 counts down, it is simultaneously sending signals
which drive and correctly illuminate a treatment time display panel
90. The treatment timer 48 can also be stopped by a disable pulse
received from the power level controller circuit 44. The disable
signal is automatically generated when an operating deviation in
the RF output circuitry is detected.
[0073] FIG. 5 is a block diagram of a power level controller 44 for
incorporation in the present invention. The power level controller
44 is a multi-function circuit that can monitor and control the
pulsed RF energy outputs to multiple applicators 14. Many of the
sub-circuits shown in FIG. 5 are repeated for each treatment
applicator. For the sake of clarity, FIG. 5 illustrates only one of
these sub-circuits, and includes additional circuits that are
common for basic treatment applicator operation. FIG. 6 completes
the overall interconnections for operation, and illustrates
multiple sub-circuits required for, as an example, three treatment
applicators 14.
[0074] The controlling sub-circuit that permits pulsed RF energy to
reach a treatment applicator 14 is the RF power enable circuit 92.
Circuit 92 is activated by an enable signal 94 from the treatment
timer 48 and an enable signal 96 from the isolated power supply
control 52. When enabled, the RF power enable circuit 92 sends an
RF power enable signal 98 to the RF amplifier power control 100.
Circuit 100 controls the RF power level to the RF power amplifier
36. When RF power is being transmitted to the treatment applicator
pad 14, the RF power enable circuit 92 switches on an indicator
lamp 102.
[0075] Forward RF power signals 104 and reflected RF power signals
106 from measuring circuit 46 are delivered to voltage comparators
108 and 110, respectively. Voltage comparators 108 and 110 allow
the setting of maximum forward and reflected power levels. If
either of the measured power outputs is above/below its respective
set-point level, a disable signal is sent to the RF power enable
logic circuit 92, switching off RF power to one, a few or all low
power RF amplifiers 36, switching off the treatment timer 48, and
sending a signal to an optional alarm circuit 112. During a high
forward or reflected power condition, indicator flashing circuit
114 is enabled which then starts flashing the single service
required LED 116.
[0076] The actual RF energy that is transmitted from each treatment
applicator 14 is measured by a detector located on the treatment
applicator (FIG. 11). This field strength signal 118 is used to
automatically regulate and control the RF output to the treatment
applicator 14. Additionally, signal 118 is evaluated to determine
if operation of the apparatus should be halted. Specifically,
comparator 120 sets a maximum field strength level, and comparator
122 sets a minimum field strength level. If the measured field
strength is outside these limits, a disable signal is sent to the
RF power enable logic circuit 92, switching off RF power to all RF
amplifiers 36, switching off the treatment timer 48, and sending a
signal to an optional alarm circuit 112. During an out-of-range
condition, indicator flashing circuit 114 is enable which then
starts flashing the single service required LED.
[0077] When the treatment applicator 14 is in place, a body
proximity sensor switch (FIG. 9) is closed, and the applicator in
place LED 124 is illuminated. If this switch inadvertently opens,
an indicator flashing circuit 126 is enabled and the check
applicator LED 128 flashes.
[0078] FIG. 6 describes in more detail how one embodiment of the
present invention operates. Initially, a crystal controlled
oscillator 130 is stimulated following input of a DC supply voltage
132. The oscillator then generates a sine wave output 134 having a
frequency of about 27.12 MHz to a preamplifier 136 controlled by an
external switch 138 so that its output 140 consists of pulses of
specific duration and repetition rate as controlled by the pulse
rate generator and treatment energy pulse shaper and pulse
repetition controller 40. The output of this stage of gain drives
another amplification stage 142 which draws no current unless an
input signal is present (Class C amplifier). This particular
feature is an important improvement in that it is one of the
features allowing for the use of a very low power amplifier to
drive an effective output treatment RF signal. The output 144 of
amplifier stage 142 then drives two additional power amplifiers
146, 148, also operating as Class C amplifiers. The Class C
operation of additional power amplifiers 146, 148 also contributes
to the ability to use low input power. The output 150 of the final
amplifier is applied to the treatment applicator 14 via a coaxial
cable connected to port 152.
[0079] FIG. 6 further shows one preferred circuit for adjusting the
amplifier output. Field strength signal 131 is applied to one input
133 of comparator 135. The other input 137 of comparator 135 is a
preset signal or a voltage from the controller. The output 139 of
comparator 135 goes to opeational amplifier 141. The signal is then
amplified further by voltage regulator 143. Voltage regulator 143
supplies DC power to the RF oscillator 130 and amplifier, thereby
adjusting the output of the amplifier and, hence, the treatment
dosage.
[0080] FIG. 7 is a block diagram of an embodiment of the present
apparatus 10 having multiple treatment applicators 14. As
previously discussed, the power level controller 44 includes
multi-tasking circuits that permit the addition and separate
control of multiple treatment applicators 14. As shown in FIG. 7,
the present invention allows for the concurrent treatment of
multiple wound sites on a single patient where each wound site
requires a different treatment profile.
[0081] FIG. 7 illustrates the embodiment of multiple sub-circuits
that are required for, as an example, three treatment applicator
pads. Each autonomous circuit incorporates separate low power class
C RF amplifiers 36 and forward and reflected power measuring
circuits 46. Separate indicator lamps 102, 124, 128 are provided
for applicator in place 27, check applicator 28, and treatment
power on 29. Separately controlled RF energy pulses, which are
transmitted through the individual forward and reflected power
measuring circuits 46 are connected to separate treatment
applicators 14 via labeled flexible cables, each applicator 14
having its own detectors and sensors (FIGS. 9 and 10).
[0082] From each treatment applicator 14, separate signals from the
detector and body proximity sensor are sent to individual control
circuits in the power level controller 44 to independently monitor
and control the RF output level radiating from each treatment
applicator 14.
[0083] Each control circuit of the power level controller 44 is
automatically activated when a treatment applicator 14 is connected
to the electromagnetic energy output device. When a treatment
applicator 14 is disconnected, or if its body proximity sensor is
in an open circuit condition, the associated control circuit of the
power level controller 44 is automatically de-activated.
[0084] FIG. 8 is a block diagram of an isolated power supply
assembly 52 of the present invention. Unit 12 is powered by a
source 18, such as an internal battery pack, which can be
periodically recharged using a peripheral AC line cord. An isolated
power supply control 158 continuously checks the voltage from the
battery pack 18, advises the operator when it is time for
re-charging, and disables all RF output functions when the battery
voltage drops below a minimum level. Specifically, direct battery
voltage is sensed by amplifier 160. The output of amplifier 160 is
monitored by a display driver circuit 162. Circuit 162 is wired to
illuminate the low LED 164 when the battery voltage is below a
defined voltage level and requires re-charging, to illuminate the
OK LED 33 when the battery voltage is at an acceptable voltage
level, and to flash the high LED 34 if the battery voltage is
sensed to be higher than an acceptable limit. If the battery
voltage is OK, an output signal 170 is sent to the power level
controller 44, enabling the RF power enable circuitry.
[0085] The monitoring of battery voltage is very important because
it assures that electronic circuits are being powered with adequate
supply voltage, that treatment RF dosage is not compromised due to
low battery voltage, and that electronic circuits (including
battery) are not stressed or damaged due to excessively high or low
battery voltage.
[0086] FIGS. 9-13 show preferred embodiments of the applicator 14
of the present invention. As shown in FIGS. 9-13, the applicator 14
is a monolithic assembly of one or more circuits having a fixed
capacitance. This important feature renders the device
substantially unaffected by impedance, capacitance and other
related affects associated with locating an electromagnetic energy
applicator in proximity to a patient's body. Unlike prior art
devices which require manual adjustment of the capacitor(s) in the
applicator at the treatment site, the present invention has a
capacitance fixed by the manufacturer, thereby rendering the device
user friendly. Each applicator includes one or more circuits (such
as etched copper printed circuit, stamped wire circuit, etc.)
formed on a single substrate, such as an assembly comprising one or
more circuit boards. Preferably, the circuits are etched or
otherwise located on opposite surfaces of a single circuit
board.
[0087] Referring to one embodiment of the present applicator shown
in FIGS. 9-11, applicator 14 includes a single circuit 174 that is
laminated between insulating sheets of flexible Kapton 178, or
similar material with high dielectric properties. Circuit 174
includes an etched inductor 180, a fixed capacitor 192 connected in
parallel with inductor 180, a signal detector 182, and a body
proximity sensor 184. A ground plane 176, such as a solid RF copper
shield, is located directly below the first etched printed circuit
174. Circuit 174 and plane 176 are brought out to a connection
interface 186 to which a flexible and shielded, multi-conductor
cable 188 is permanently attached. Connection to the generator unit
12 is made through connector 190, shown in FIG. 10. That composite
assembly defines the completed applicator 14.
[0088] FIGS. 12 and 13 show an alternative embodiment of the
applicator described above having multiple circuits 174 and 177. In
the applicator 14, the upper circuit 174 forms the secondary of an
RF transformer. The primary circuit 177 is etched on the other side
of this two sided board. The upper circuit 174 (secondary), which
is a multi-turn spiral, has a fixed, surface mount capacitor 192
connected in parallel with it to form a tank circuit resonant at
27.12 Mhz. Circuit 177 (primary), comprising a single turn, has a
fixed, surface mount capacitor 194 connected in series. The ends of
this series-resonant circuit are brought out to a connection
interface 186 from which it is then connected to controller 44 and
RF amplifier 36. The function of the LC tank circuit is to radiate
a pulsed RF energy in the form of a closed and concentrated RF
electromagnetic energy field.
[0089] Circuit 174 also includes detector 182. Detector 182 is
brought out to the connection interface 186 and serves as an RF
energy measuring element, and as such, measures, monitors,
regulates and controls the magnitude of the pulsed electromagnetic
energy field, or treatment dosage, as it radiates out from the
applicator. The returned signal level from detector 182 is sent to
the power level controller 44, where it is used as a feedback
control signal. If at any time, detector 182 measures radiated
electromagnetic energy output level above or below an acceptable RF
level, a service required lamp (FIG. 3) will flash and the power
level controller disables the RF energy output.
[0090] It should be understood that any appropriate detector 182,
such as a germanium diode, may be used without departing from the
scope of the present invention.
[0091] Applicator 14 also includes a body proximity sensor switch
184. Switch 184 confirms that applicator 14 is in place and
attached to the patient and that the emitted pulsed RF energy field
is being efficiently coupled from the applicator 14 to the patient.
In use, applicator 14 is either placed under the patient, in close
proximity to the patient's wound, or wrapped around the limb of a
patient and attached with fasteners, or is placed over a wound,
again being held in place with fasteners. If applicator 14 is
secured correctly, the body proximity sensor switch 184 closes,
indicating to the power level controller 44 that applicator 14 is
in place, and a lamp indicating applicator in place 27 is
activated. If any time during treatment, the body proximity sensor
switch 184 opens, indicating that applicator 14 is not in body
contact, a check applicator 28 lamp flashes and the power level
controller 44 disables the RF energy output.
[0092] Unlike many prior art devices, which are magnetic field
based and, in some instances, prevent the electrical field
component of the electromagnetic energy from being transmitted, the
present invention relies on electrical field-based information for
effective operation. Electrical field strength detector 182
included in each applicator 14 produces a DC voltage as a function
of the actual field strength being transmitted from applicator 14.
This DC voltage is transmitted in a reverse manner (antidromically)
through the same coaxial cable 188 which carries the RF signal from
amplifier 36 to applicator 14. In this manner, only one cable is
required to carry and process both the RF power and RF detection
signals. This represents a substantial improvement over the prior
art, none of which have a signal detection means at the level of
the actual RF signal output, and none of which carry this detection
signal over the same cable as used for transmitting the RF
signal.
[0093] In the RF generator 30, this DC voltage (detection signal
118) is compared to a reference DC voltage which represents the
desired field strength. The output of the comparator 120, 122
drives suitable amplifiers 100 which control the DC power supply
voltage to the RF circuits, thus controlling the forward RF power.
The field strength, being a function of the RF power, is thereby
accurately controlled and maintained. This is a significant
improvement not found in existing devices, and represents the first
capability to accurately deliver, monitor and automatically control
the actual RF power delivered to the tissue being treated, thereby
ensuring an accurate dosage delivery and dosimetry system.
[0094] The circuits are located on a single substrate, such as a
circuit board. The substrate is preferably thin and may be flexible
or rigid and constructed from one or more sheets. When multiple
circuits are included (FIGS. 12 and 13), the circuits are
preferably concentrically located on the substrate. While it is not
necessarily required that the circuits be exactly concentric, best
results are achieved when the two circuits are as close to
concentrically positioned as possible.
[0095] Preferably, the applicator 14 is approximately 6 inches by 8
inches by less than 1 inch thick, and is housed within a waterproof
outer covering. The outer surface is water proof, bacterial
resistant and designed to be placed directly on the patient or on
top of any standard dressings used over the area to be treated. The
generating unit 12 is about 2.5 inches by 5 inches by 8 inches, and
has a weight of less than three pounds. In a preferred embodiment,
unit 12 includes a display panel which contains the operating
switch or button, a treatment time remaining display, a light which
is on during treatment to notify the operator that treatment is
occurring, and a service light which comes on if the unit needs
servicing.
[0096] Unit 12 is a hand-held one, which is easily transported from
site to site. Applicators 14 are self supporting structures which
do not require any mechanical support structure for positioning.
Indeed, the only means connecting the applicator 14 to the
generating unit 12 is a cable.
[0097] Reference throughout this description to LEDs and other
specific indicators was made for descriptive purposes only. It is
understood that other indicating means for informing users of
operational conditions are interchangeable with the specific
indicators disclosed herein.
[0098] Treatment dosages of electromagnetic energy are applied as
follows. The control logic circuit is programmed with treatment
profiles which enable the oscillator to provide a treatment dosage
of about 1-300 mw/cm.sup.2. The preferred treatment profile is
administered twice a day, eight to twelve hours between treatments,
for thirty minutes. Indeed, the unit is preferably factory preset
to deliver treatment for thirty minutes and requires no operator
adjustment. When ready, the "start/stop" button is pressed. When
this button is pressed, the indicator light indicates therapy has
started and an electromagnetic energy dosage is generated and
delivered to the treatment site. The electrical field at the
treatment site is continuously monitored, with information being
delivered back to the generating unit to control the dosage level.
At the end of thirty minutes, the unit turns itself off and the
power indicator light becomes dark.
[0099] The following are representative examples of treatments
administered using the present invention.
EXAMPLE 1
[0100] This example describes treatment on fibroblasts, a cell type
critical to the wound healing process, using the present invention.
Immortalized (Rat-2) or primary (human SA-1) fibroblasts were
plated 24 hours prior to treatment in 96-well trays at initial
densities from 500-10,000 cells per well in Dulbecco's modified
Eagle's medium supplemented with high (10% horse, 5% fetal calf) or
low (0.5% fetal calf) serum. Cells were treated either with the
present invention or a control. The treatment parameters for the
present invention, i.e., pulse duration, peak power, average power
(dose) and rate of pulse presentation, were systematically varied.
Optimal average power, pulse duration and repetition rate were
shown to be about 32 mw/cm.sup.2, about 32 .mu.s, and a mean of
about 1,000 pps respectively. Systematic changes in proliferative
response as a function of changes in parameter value were found for
all conditions. These results demonstrate that specific
characteristics of the present invention critically influence the
efficacy of response, and provide a clear picture of the optimum
control logic parameters necessary for efficacious treatment of
wounds in a clinical setting.
EXAMPLE 2
[0101] This example evidences the dose- and time-dependent effects
of treatment using the present invention on Rat-2 immortalized and
SA-1 human primary fibroblasts in culture. Cells plated in
multi-well trays at a series of densities in medium supplemented
with serum at different concentrations were treated using the
present invention at an average dose of betweeen about 0-178
mw/cm.sup.2. Other cells were treated with 32 mw/cm.sup.2 for 0 to
60 minutes. After 24 hrs, cells were quantitated directly, via
mitochondrial enzyme activity or crystal violet staining. When
control logic circuits were preset to provide a pulse width of 32
microseconds and a pulse rate of about 600-1,000 pulses per second,
proliferation was significantly enhanced (50-200%, p<0.001) with
an ED.sub.50 of 15 mw/cm.sup.2 and an ED.sub.99 of 32 mw/cm.sup.2.
Maximal proliferation occurred following 15-60 min treatment time
with 1/2-maximal effects at 8 min. These results reveal optimal and
minimal doses and times of treatment to trigger proliferation
response.
EXAMPLE 3
[0102] Example 3 describes a novel and proprietary method of
accelerating healing to closure of chronic cutaneous wounds. It is
clear that effects seen clinically and in vitro are based upon
enhanced pro-proliferative effects. Evidence for a specific
mechanism for enhanced cell proliferation has now been obtained.
Rat-2 immortalized or SA-1 human primary fibroblasts seeded at
initial densities from 500-10,000 cells per well were treated with
a 32 mw/cm.sup.2 dose or sham treated (naive). At times ranging
from 0 to 16 hr posttreatment, medium was removed from wells
containing treated cells and transferred to wells containing naive
cells. To define positive and negative controls, respectively, some
treated cells were kept in medium throughout, and some naive cells
were not exposed to treated medium. At 24 hr posttreatment, all
cells were crystal violet stained and quantified
spectrophotometrically. Modest proliferation above control levels
was observed for cells treated with the present invention, even if
medium was removed immediately after treatment, but larger and
time-dependent increases in numbers of cells treated with the
present invention were obtained if medium was left on those cells
for 5-16 hours. Proliferation of naive cells was also observed if
they received treated cell medium 0-16 hr after treatment. These
studies show that diffusible entities promoting cell proliferation
are released into and conditions cell culture medium upon treatment
using the present invention.
EXAMPLE 4
[0103] This example describes a clinical study wherein a novel,
noninvasive endogenous pharmacotherapeutic wound treatment was
realized. Twenty High or Moderate Risk patients with Stage II, III
or IV pressure ulcers were entered into this study. This group
presented with very severe wounds relative to the total pressure
sore population. Mean study wound surface area was 17.6.+-.2.1,
compared to a population average of 6.6.+-.1.3, and all patients
were severely compromised in nutritional and medical status.
Patients were treated for thirty minutes twice daily, with a dose
equal to about 32 mw/cm.sup.2 measured at a distance of about 6 cm
from the applicator surface. All patients responded positively to
the present treatment. Stage II wounds closed in about 3-5 weeks,
compared to a norm of about 8 weeks for smaller wounds. Stage III
and Stage IV wounds showed similar acceleration of wound healing.
Average rate to closure was about 28 mm.sup.2/day, compared to
population norms of 3-9 mm.sup.2/day for patients not treated with
the present method. A highly novel finding is that tissue repair
was stimulated through several layers of the wound bed, with rapid
loss of necrotic tissue and simultaneous robust granulation.
According to these data, the present invention reduces the time
associated with wound healing by 50%.
[0104] The above examples are provided by way of illustration, and
are not intended to limit the scope of the present invention.
[0105] It should be understood that references to wound treatment
are not limited to the induction of granulation, epitheliation and
vascularization at a wound site, but also includes restoring
nutrient load to a wound site, thereby inducing synthesis of growth
factors, inducing the synthesis, proliferation and release of
fibroblasts, epithelial, endothelial, vascular, muscle and neuronal
cell types, inducing macrophage activity in a wound site,
increasing mitogenic stimuli, increasing concentration of and
inducing effective biological activity of growth factors within a
wound site, delivering multiple growth factor therapy to a tissue,
altering activity of cell cycle dependent proteins, inducing
synthesis and activity of signal transduction molecules, and
inducing gene expression in a tissue, among other events. Further,
while the present invention is described in terms of human
treatment methods, it should be understood that treatment, as used
herein, encompasses laboratory applications and procedures as well
as veterinary applications and the like.
[0106] From the foregoing, it will be appreciated by those skilled
in the art that the present invention provides a particularly
effective and advantageous method of and apparatus for overcoming
many of the limitations associated with the treatment of patients
using electromagnetic energy. It will also be readily appreciated
by one with ordinary skill in the art to use the method and
apparatus of the present invention in other applications, such as
veterinary applications.
[0107] Although certain presently preferred embodiments of the
present invention have been specifically described herein, it will
be apparent to those skilled in the art to which the invention
pertains that variations and modifications of the various
embodiments shown and described herein may be made without
departing from the spirit and scope of the invention.
* * * * *