US007024239B2
`
`(12)
`
`United States Patent
`George et al.
`
`(10) Patent No.:
`(45) Date of Patent:
`
`US 7.024.239 B2
`Apr. 4, 2006
`
`(54) PULSED ELECTROMAGNETIC ENERGY
`TREATMENT APPARATUS AND METHOD
`
`(75) Inventors: Frank R. George, Scottsdale, AZ (US);
`Arthur A. Loya, Mesa, AZ (US);
`M C. Ritz, Scottsdale, AZ (US):
`ary C. Ritz, Scottsdale, AZ (US);
`Robert T. Bryant, Tempe, AZ (US)
`O
`O
`(73) Assignee: Regenesis Biomedical, Inc., Scottsdale,
`AZ (US)
`Subject to any disclaimer, the term of this
`patent is extended or adjusted under 35
`U.S.C. 154(b) by 235 days.
`
`(*) Notice:
`
`21) A1. No.: 09/994,598
`(21) Appl. No
`9
`(22) Filed:
`Nov. 20, 2001
`
`(65)
`
`Prior Publication Data
`US 2002/0040233 A1
`Apr. 4, 2002
`Related U.S. Application Data
`(63) Continuation of application No. 09/231,790, filed on
`Jan. 15, 1999, now Pat. No. 6,334,069.
`(60) Provisional application No. 60/071,396, filed on Jan.
`15, 1998.
`(51) Int. Cl.
`(2006.01)
`A6 IN I/06
`(52) U.S. Cl. ............................ 607/2; 607/50; 607/154;
`6077155
`(58) Field of Classification Search .................... 607/2,
`607/50, 96, 101, 103, 149-152, 154, 155;
`600/14, 15: 606/41
`See application file for complete search history.
`
`(56)
`
`References Cited
`
`U.S. PATENT DOCUMENTS
`
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`(Continued)
`FOREIGN PATENT DOCUMENTS
`
`EP
`
`O 538 510
`4f1993
`(Continued)
`OTHER PUBLICATIONS
`J.H. Goldin et al., “The effects of Diapulse on the healing
`wounds: a double-blind randomised controlled trial in man',
`Journal of Plastic Surgery, 1981, 34, pp. 267-270.
`(Continued)
`Primary Examiner Jeffrey R. Jastrzab
`(74) Attorney, Agent, or Firm—Morrison & Foerster LLP
`
`(57)
`
`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 gen
`erator can produce electromagnetic energy and the applica
`tor 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.
`
`27 Claims, 14 Drawing Sheets
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Treatinent
`Tiner
`
`so
`
`Treatment
`Energy Pulse
`Controller
`
`62
`
`s
`
`30
`
`Power level
`Controller
`42
`
`R
`
`Pl
`Se:
`Generator
`
`al
`ar TV
`
`Amplifier | Amplifier IF a
`
`Measuring
`Circuit
`
`Applicator
`4.
`
`54
`
`Measuring
`Circuit
`
`R Applicator
`
`area,
`
`14
`
`56
`
`Measuring
`Circuit
`
`pplicator
`
`
`
`56
`
`14
`
`32
`
`LUMENIS EX1030
`Page 1
`
`

`

`US 7,024.239 B2
`Page 2
`
`U.S. PATENT DOCUMENTS
`
`6, 1977 Boudouris et al.
`4,028,518 A
`4,062.365 A 12/1977 Kameny
`4,066,065. A
`1/1978 Kraus
`4,197,851 A
`4, 1980 Fellus
`4,210,152 A
`7/1980 Berry
`4.226,246 A 10/1980 Fragnet
`4,266,532 A
`5, 1981 Ryaby et al.
`4,318,411 A
`3, 1982 Elmovist
`4.323,056 A
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`4.338,945. A
`7/1982 Kosugi et al.
`
`4,619,264 A 10, 1986 Singh - - - - - - - - - - - - - - - - - - - - - - - - - - 6O7/52
`
`2, 1984 Bentall
`4,429,698 A
`2, 1984 Christensen et al.
`4,432,361 A
`6/1984 Fellus
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`8/1984 Brighton
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`9, 1984 Bentall
`4,471,787. A
`8, 1985 Brighton et al.
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`4,548,208 A 10, 1985 Niemi
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`3, 1986 Talish et al.
`4,587,957 A
`5, 1986 Castel
`4,616,629 A 10, 1986 Moore
`4,622,952. A 1 1/1986 Gordon
`4,641,633 A
`2/1987 Delgado
`4,654,574. A
`3/1987 Thaler
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`5/1987 Costa et al.
`4,671,286 A
`6/1987 Renault
`4,674,482 A
`6, 1987 Waltonen et al.
`4,683,873. A
`8, 1987 Cadossi et al.
`4,727,878 A
`3, 1988 Levine
`4,738,250 A
`4, 1988 Fulkerson et al.
`4,757,804 A
`7, 1988 Griffith et al.
`4,765,310 A
`8/1988 Deagle et al.
`4,793,325 A 12/1988 Cadossi et al.
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`4, 1989 Liboff et al.
`4,895,154 A
`1/1990 Bartelt et al.
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`1/1991 Claude
`4,993,413 A
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`4,998.532 A
`3, 1991 Griffith
`5,000, 178 A
`3, 1991 Griffith
`5,014,699 A
`5, 1991 Pollack et al.
`5,045,050 A
`9, 1991 Liboff et al.
`5,059,298 A 10/1991 Liboff
`5,088.976 A
`2f1992 Liboff et al.
`5,099,756 A
`3, 1992 Franconi et al.
`
`3, 1992 Goble et al.
`5,099,840 A
`4, 1992 Thomas
`5,107,835 A
`6/1992 Bartelt et al.
`5,117,826 A
`6/1992 Liboff et al.
`5,123,898 A
`5,158,081. A 10/1992 McWhorter et al.
`5,160,591 A 11/1992 Liboff et al.
`5,181,902 A
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`5, 195,941. A
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`5,198.941 A
`3, 1993 Tezuka
`5,267,938 A 12/1993 Konotchick
`
`8/1994 Abbott et al.
`5,338,286 A
`5,370,680 A 12, 1994 Proctor
`5,395,398 A
`3/1995 Rogozinski
`5,401.233 A
`3/1995 Erickson et al.
`5,433,735 A
`7/1995 Zanakis et al.
`5,441,495 A
`8/1995 Liboff et al.
`5,478.303 A 12/1995 Foley-Nolan et al.
`5,480,373 A
`1/1996 Fischer et al.
`5,527,259 A
`6/1996 Grace et al.
`5,549,639 A
`8, 1996 Ross
`5,549,640 A
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`5,634,939 A
`6/1997 Kuster et al.
`5,776,175 A
`7/1998 Eckhouse et al.
`5,800.458 A
`9/1998 Wingrove
`6,458,121 B1
`10/2002 Rosenstock et al.
`2003.0114884 A1
`6/2003 Moran
`
`5,584,863 A 12/1996 Rauch et al.
`
`FOREIGN PATENT DOCUMENTS
`
`WO
`
`99.19024
`
`4f1999
`
`OTHER PUBLICATIONS
`Christopher J. Schaffer et al., “Cell Biology of Wound
`Healing, pp. 151-181, Vanderbilt University School of
`Medicine, Plastic Surgery Research Laboratories, Interna
`tional Review of Cytology, vol. 169, 1996.
`& G
`Glenn F. Pierce et al., “Pharmacologic Enhancement of
`Wound Healing, Annu. Rev. Med. 1995, 46:467-81, 1995.
`CA Salzberg et al. The effects of non-thermal pulsed elec
`tromagnetic energy on wound healing of pressure ulcers in
`spinal cord-injured patients: a randomized, double-blind
`study, Ostomy Wound Management, 41(3): 42-4, 46, 48
`passim, 1995 Abstract only.
`* cited by examiner
`
`LUMENIS EX1030
`Page 2
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`

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`U.S. Patent
`
`Apr. 4, 2006
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`Sheet 1 of 14
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`US 7.024.239 B2
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`LUMENIS EX1030
`Page 3
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`U.S. Patent
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`Apr. 4, 2006
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`Sheet 2 of 14
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`US 7.024.239 B2
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`LUMENIS EX1030
`Page 4
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`

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`U.S. Patent
`
`Apr. 4, 2006
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`Sheet 3 of 14
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`US 7.024.239 B2
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`LUMENIS EX1030
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`U.S. Patent
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`US 7.024.239 B2
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`LUMENIS EX1030
`Page 6
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`

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`U.S. Patent
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`Apr. 4, 2006
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`Sheet 5 of 14
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`US 7.024.239 B2
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`LUMENIS EX1030
`Page 7
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`

`

`U.S. Patent
`
`Apr. 4, 2006
`
`Sheet 6 of 14
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`US 7,024,239 B2
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`LUMENIS EX1030
`Page 8
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`

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`U.S. Patent
`
`Apr. 4, 2006
`
`Sheet 7 of 14
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`US 7.024.239 B2
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`

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`U.S. Patent
`
`Apr. 4, 2006
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`Sheet 8 of 14
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`US 7.024.239 B2
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`LUMENIS EX1030
`Page 10
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`

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`U.S. Patent
`
`Apr. 4, 2006
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`Sheet 9 of 14
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`US 7.024.239 B2
`
`Multiple Treatment Pad Detail
`
`input from
`RF Oscator
`
`
`
`36
`
`46
`
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`
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`Power Measuring
`Circuits
`
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`
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`
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`input from Body Sensor
`
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`
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`FIG. 7
`
`LUMENIS EX1030
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`US 7,024,239 B2
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`Apr. 4, 2006
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`Sheet 11 of 14
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`US 7.024.239 B2
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`Apr. 4, 2006
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`Sheet 12 of 14
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`Sheet 13 of 14
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`US 7.024.239 B2
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`Apr. 4, 2006
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`Sheet 14 of 14
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`US 7.024.239 B2
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`US 7,024,239 B2
`
`1.
`PULSED ELECTROMAGNETIC ENERGY
`TREATMENT APPARATUS AND METHOD
`
`CROSS-REFERENCE TO RELATED
`APPLICATIONS
`
`The present application is a continuation application of
`U.S. patent application Ser. No. 09/231,790, entitled
`IMPROVED PULSED ELECTROMAGNETIC ENERGY
`TREATMENT APPARATUS AND METHOD, filed on Jan.
`10
`15, 1999, now 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 is incorporated herein by reference.
`
`TECHNICAL FIELD OF THE INVENTION
`
`15
`
`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
`
`2
`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.
`Clearly, growth factors are important messengers in coor
`dinating this complex orchestration of cellular events.
`Today, growth factors refer to an expanding class of mol
`ecules, sometimes with specificity for certain types of cells,
`that can have either pro-proliferative or anti-proliferative/
`differentiation effects, depending upon the specific circum
`stances. 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.
`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 tis
`Sue/organ repair and remodeling is the critical revascular
`ization of damaged tissue. Vascular endothelial growth fac
`tor (VEGF) is a recently discovered agent that promotes
`proliferation and migration of endothelial cells. Stimulating
`the expression of VEGF receptors in endothelial cell pre
`cursors 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 fibro
`blasts and/or other cell types (or stimulating VEGF produc
`tion 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 extracel
`lular matrix materials such as collagen. Moreover, stimulat
`ing FGF receptor production in fibroblasts capable of rec
`ognizing 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 pres
`SU SOS.
`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.
`
`25
`
`30
`
`35
`
`40
`
`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.
`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 neces
`sary for the initiation of cell growth and migration and tissue
`regeneration, which collectively constitute the wound heal
`ing 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.
`45
`There are distinct phases associated with the process of
`wound healing. In the inflammatory phase, platelets aggre
`gate 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 inflam
`matory 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 pro
`duced 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 appear
`ance, 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
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`3
`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.
`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, angiogen
`esis, 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 pro
`mote wound healing. Overall, the complexity and variability
`of clinical wounds have limited pharmacological approaches
`to accelerate wound healing, leaving dressings and nonp
`harmacological ancillary modalities to dominate the market
`associated with wound management.
`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
`35
`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 prox
`imity 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
`45
`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.
`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.
`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 pre
`vention and treatment of pressure ulcers in 1992 and 1994,
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`60
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`US 7,024,239 B2
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`10
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`15
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`25
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`30
`
`4
`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 guide
`lines 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.
`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. Appli
`cation 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.
`Clinical research has shown that treatment with electrical
`stimulation or electromagnetic fields can enhance the heal
`ing 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 prolifera
`tive 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 corre
`lates 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 prolif
`eration, collagen synthesis and the expression of fibroblast
`receptors for transforming growth factor-beta.
`Treatment devices emitting magnetic and/or electromag
`netic 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 com
`pletely non-invasive. Moreover, published reports of double
`blind placebo-controlled clinical trials utilizing a RF trans
`mission device (Diapulse) suggest that this ancillary treat
`ment 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.
`One category of prior art magnetic/electromagnetic treat
`ment devices utilizes the passage of electrical currents
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`Page 18
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`5
`through coils of wire to create magnetic fields. The fre
`quency 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.
`Another category of prior art electromagnetic treatment
`apparatus includes high frequency, high power devices uti
`lizing 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. patents: Milinowski, U.S. Pat. Nos. 3,043,
`310 and 3,181,535; Kendall U.S. Pat. No. 3,543,762: Pearo
`U.S. Pat. No. 3,670.737; and most recently Rauchet. al.,
`U.S. Pat. No. 5,584,863. Those earlier inventions first
`described and defined the principle and operation of pulsed,
`high frequency energy output devices and/or systems.
`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 genera
`tor and an a thermapeutic 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 hav
`ing manually operable dials is provided for controlling pulse
`width duration, pulse burst repetition rate and power ampli
`tude 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 pro
`duces a ratio signal that is delivered to the controller for
`adjusting the amplitude and phase of the signals generated
`40
`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 require
`ments, 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.
`While the various and several prior art inventions, as
`described in the above referenced patents, produce electri
`cal, 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.
`Additionally, none of the previous high frequency, high
`power devices utilizing pulsed electromagnetic energy out
`put 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.
`
`6
`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.
`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 represen
`tation as to the contents of these documents is based on the
`information available to the applicants and does not consti
`tute 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
`
`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 pro
`viding 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 treat
`ment dosage delivery without the need for manual adjust
`ment of power, pulse rate duration, pulse width duration,
`treatment time or reactance by the treatment provider.
`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 proX
`imity of the body of the patient (e.g., capacitance, induc
`tance).
`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 dif
`ferent treatment dosages.
`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.
`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.
`It is a yet further object of this invention to provide an
`electromagnetic energy treatment apparatus having the abil
`ity to affect living tissue by providing an accurate treatment
`dosage of 1 to 300 mw/cm 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).
`It is a still further object of this inven