WO2001015770A2 - Procede electromagnetique permettant de traiter des lesions liees a une perfusion sanguine inadaptee, une denervation partielle, une perte tissulaire, la douleur, un oedeme, une inflammation et infection - Google Patents

Procede electromagnetique permettant de traiter des lesions liees a une perfusion sanguine inadaptee, une denervation partielle, une perte tissulaire, la douleur, un oedeme, une inflammation et infection Download PDF

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Publication number
WO2001015770A2
WO2001015770A2 PCT/IB2000/001480 IB0001480W WO0115770A2 WO 2001015770 A2 WO2001015770 A2 WO 2001015770A2 IB 0001480 W IB0001480 W IB 0001480W WO 0115770 A2 WO0115770 A2 WO 0115770A2
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Prior art keywords
housing
ulcers
magnetic field
static magnetic
time
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PCT/IB2000/001480
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English (en)
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WO2001015770A3 (fr
Inventor
Luis Canedo
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Luis Canedo
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Priority to AU76793/00A priority Critical patent/AU7679300A/en
Priority to CA002389134A priority patent/CA2389134C/fr
Publication of WO2001015770A2 publication Critical patent/WO2001015770A2/fr
Publication of WO2001015770A3 publication Critical patent/WO2001015770A3/fr

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N2/00—Magnetotherapy
    • A61N2/02—Magnetotherapy using magnetic fields produced by coils, including single turn loops or electromagnets
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/40—Applying electric fields by inductive or capacitive coupling ; Applying radio-frequency signals
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N2/00—Magnetotherapy
    • A61N2/004—Magnetotherapy specially adapted for a specific therapy
    • A61N2/008—Magnetotherapy specially adapted for a specific therapy for pain treatment or analgesia

Definitions

  • the present invention relates generally to a method for treatment of skin lesions and internal wounds such as viable but unde ⁇ erfused myocardium. More specifically, this invention is related to a method for treatment of a subject afflicted with inadequate blood perfusion, tissue loss, partial denervation, wounds, bone fractures, burns and/or ulcers, by administration of time varying electromagnetic fields alone or simultaneously with static magnetic fields to the subject of specific characteristics.
  • EMFs Locally applied electromagnetic fields
  • EMFs have been shown to increase skin and nerve regeneration, collagen maturation and tensile strength during healing of skin wounds in the rat.
  • EMFs have been shown also to induce the proliferation and collagen-mediated production of fibroblasts and foster angiogenesis.
  • locally applied EMFs have long been known to promote soft tissue repair.
  • Chronic venous leg ulcers and pressure ulcers have been treated by application of various therapies, including the local application of growth factors, hyperbaric oxygen, local infrared irradiation, EMFs, ultra violet and low energy lasers as well as ultrasound, directly to the ulcerated site.
  • therapies including the local application of growth factors, hyperbaric oxygen, local infrared irradiation, EMFs, ultra violet and low energy lasers as well as ultrasound, directly to the ulcerated site.
  • EMFs as the sole adjunctive therapy with sufficient supporting evidence for the treatment of pressure ulcers.
  • EMFs have been used to treat chronic venous leg ulcers, nerve regeneration, bone nonunionis and to protect animal models from the sequela of provoked ischemia, all attempts to attain healing by administration of EMFs at a point distant from the afflicted site have failed up to the present time.
  • This invention relates to a method of treating lesions, burns, skin ulcers, and viable but underperfused myocardium, which comprises applying externally and non- invasive extremely iow frequency electromagnetic fields (EMFs) of specific characteristics to a subject afflicted with a sion burn and ulcer, at a site removed from the site of the lesion under conditions effective to accelerate lesion, burn, bone or ulcer healing, to enhance angiogenesis and vasculogenesis and to improve the effect of other subsequently applied therapies.
  • EMFs extremely iow frequency electromagnetic fields
  • Suitable EMFs comprise a time- varying electromagnetic field component generated at frequencies of a few Hertz (more than one) to less than about 300 Hz and static magnetic field components having an intensity of about few micro Tesla, e.g., about 2-5 ⁇ T, about 20 ⁇ T to about 100 ⁇ T, about 0.3 mT, about 0.8 mT.
  • These EMFs may be used alone or in combination with a homogeneous static magnetic field of about 40, about 50 to about 70, about 80 mT (or about 400, about 500 to about 700, about 800 Gauss).
  • the measured frequencies inside the coils are about 0.3 to about 0.8 ⁇ T, in those areas of the skin close but not inside the coils, the intensities of the EMF are progressively reduced down to the environmental magnetic fields.
  • the method of this invention is particularly suited for the therapeutic treatment of subjects afflicted with skin lesions such as bums, internal wounds such as bone fractures, partial denervation, and ulcers, particularly chronic wounds, such as venous and arterial leg ulcers, pressure ulcers, unhealing wounds, infected wounds, painful inflamed tissue, areas of inadequate blood perfusion, such as viable but unde ⁇ erfused myocardium and the like, which are present either by themselves or in association with other causes, e.g. atherosclerosis, varicose veins, diabetes, hypertension, rheumatoid arthritis, trauma, and the like.
  • skin lesions such as bums, internal wounds such as bone fractures, partial denervation, and ulcers
  • chronic wounds such as venous and arterial leg ulcers, pressure ulcers, unhealing wounds, infected wounds, painful inflamed tissue, areas of inadequate blood perfusion, such as viable but unde ⁇ erfused myocardium and the
  • the present method may be administered for a short period of time as well as through periodically exposing an already treated subject to repeated treatments over a period of time effective for reducing the intensity of pain, edema, inflammation and infection, increasing angiogenesis, vasculogenesis, nerve regeneration, bone union and reestablishing the subject's own immune-mediated anti-inflammatory response and wound healing processes.
  • the present therapeutic method greatly reduces the healing time in subjects who had proved previously highly resistant to other conventional medical treatments.
  • the first way utilizes a design to combine time- varying magnetic fields with static magnetic fields.
  • Two different embodiments of the apparatus of this invention related to the first design are provided for this pu ⁇ ose.
  • the first embodiment of this design of the apparatus is described in Figures 1 to 7.
  • Figure 1 depicts a simplified partial perspective view of the apparatus of the present invention as viewed from the outside.
  • Figure 2 depicts a partial perspective and sectional view of the apparatus shown in Figure 1.
  • Figure 3 shows a schematic representation of the magnetic flux generated by the combined variable and static magnetic fields generated in accordance with this invention.
  • Figure 4 shows a graphic representation of the waveform generated by the electric current supplied to the coils by the electrical circuit in all the embodiments of the apparatus of this invention.
  • Figure 5 shows a graphic representation of the frequency distribution of the electromagnetic signals generated by all the embodiments of the apparatus of this invention.
  • Figure 6 is a simplified schematic top view of an arm extended inside the solenoid and the permanent magnets such as those shown in Figure 2.
  • Figure 7 is a schematic diagram of the electrical power supply circuitry used to energize the solenoid of the apparatuses of this invention.
  • the second embodiment of the first design of the apparatus of the invention is shown in
  • FIG. 8 to 10 This embodiment is an enlarged version of the first embodiment shown in Figures 1 and 2.
  • Figure 8 depicts a perspective view of the apparatus of the present invention exposing a human body to EMFs.
  • Figure 9 depicts a side perspective view of the apparatus shown in Figure 8.
  • a second design of the apparatus of the invention exposes the body part only to the time- varying magnetic fields. Five different embodiments of the apparatus of this invention are exemplified for this p pose.
  • Figure 10 depicts a simplified partly perspective view of the apparatus of the present invention as viewed from the outside.
  • Figure 11 depicts a partial perspective and sectional view of the apparatus shown in Figure 10.
  • Figure 12 shows a schematic representation of the electromagnetic flux generated by the time-varying magnetic fields in accordance with this invention.
  • Figure 13 is a simplified schematic top view of an arm extended between the magnetic coils such as the coils shown in Figure 11.
  • the second of the five embodiments is shown in Figures 14 to 16. This is a simplified version of the embodiment shown in Figures 10 to 13.
  • Figure 14 depicts a simplified perspective view of the apparatus of the present invention as viewed from the outside.
  • Figure 15 depicts a partial perspective and sectional view of the apparatus shown in Figure 14.
  • Figure 16 is a simplified schematic top view of an arm extended between the magnetic coils such as the coils shown in Figure 15.
  • Figure 17 depicts a side perspective view of the apparatus of the present invention exposing a body to EMFs.
  • Figure 18 depicts a perspective view of the apparatus shown in Figure 17.
  • the time- varying magnetic fields of the present invention are generated by two Hemholtz coils.
  • Figures 19 to 23 describe this embodiment.
  • Figure 19 depicts a simplified perspective view of the apparatus of the present invention as viewed from the outside.
  • Figure 20 depicts a perspective and sectional view of the apparatus shown in Figure 19.
  • Figure 21 shows a schematic representation of the electromagnetic flux generated by the time-varying magnetic fields in accordance with this invention.
  • Figure 22 shows a simplified perspective view of a body extended between the magnetic coils of the apparatus shown in Figure 19.
  • Figure 23 depicts a simplified perspective view of a body extended between the magnetic coils of the apparatus shown in Figure 22 wherein the apparatus is placed upside down and is fixed to the bed.
  • Figure 24 is a schematic diagram of the electrical power supply circuitry used to energize the magnetic coils of the apparatus of this invention.
  • the fifth embodiment of the apparatus is shown in Figures 25 to 28.
  • the time-varying magnetic fields of the present invention are generated by coils in a saddle disposition.
  • Figure 25 depicts a simplified perspective view of the apparatus of the present invention as viewed from the outside.
  • Figure 26 depicts a partly perspective and sectional view of the apparatus shown in Figure 25.
  • Figure 27 shows a schematic representation of the electromagnetic flux generated by the time-varying magnetic fields in accordance with this invention.
  • Figure 28 is a simplified perspective view of a limb of an animal extended between the magnetic coils such as the coils of the apparatus as shown in Figure 26.
  • Figure 29 shows the effect of the magnetic field on the proliferation of peripheral blood mononuclear cells (PBMCs) obtained from normal subjects.
  • PBMCs peripheral blood mononuclear cells
  • the stimulation of PMBCs proliferation by phytohaemaglutinin alone without EMF effect is taken as 100%.
  • the effect of combined static and time-varying magnetic fields produced an 11.1 % increase in PBMCs proliferation (p ⁇ 0.001 by Student "T" test).
  • the static magnetic field alone had no statistically significant effect on the proliferation of PBMCs.
  • This invention arose from a desire by the inventor to improve on prior art technology and various somewhat ineffective therapeutic treatments which, in addition, require direct administration to the site of the lesion. This makes them cumbersome, difficult to carry out, and definitely inconvenient to the patient.
  • the present inventor su ⁇ risingly discovered that when a subject with chronic skin lesion(s) and or internal wounds such as bone fracture, partial denervation or viable but unde ⁇ erfused myocardium, is treated by applying an electromagnetic field (EMFs) to a portion of the subject's body in accordance with this invention, the lesions show activated inflammatory reaction and wound repair, and as a result the lesions are drastically and readily reduced, and in many cases readily healed and/or completely eliminated. This is the case even for lesions that are resistant to other generally effective therapies.
  • EMFs electromagnetic field
  • the beneficial results obtained by the inventor are realized by subjecting a site of the subject's body such as a limb, e.g. arm, hand, leg or foot, or even the whole body to the action of specific electromagnetic fields (EMFs) having specific constant and variable components.
  • EMFs electromagnetic fields
  • the present inventor has su ⁇ risingly found that when such subjects are exposed to external, non-invasive electromagnetic fields (EMFs) in accordance with this invention, they become responsive to previously ineffective treatments, e.g., with known wound healing dmgs and other therapies.
  • EMFs electromagnetic fields
  • Many subjects that may benefit from the present treatment have histories of acute myocardial infarction, venous or arterial leg ulcers, bums, pressure ulcers, surgically infected wounds, bone fractures, tissue loss, partial denervation, inadequate blood perfusion and painful inflamed soft tissue, among others, which are resistant or non-responsive to treatment with surgical, pharmacological, or more conventional methods available.
  • This invention utilizes especially configured electromagnetic fields (EMFs) which may be advantageously applied at a site removed from the wound.
  • EMFs electromagnetic fields
  • the present EMFs stimulate a subject's immune system, including and preferably the subject's activated and memory peripheral blood mononuclear cells (PBMCs), although EMF's action on other EMF's exposed body tissues is not excluded.
  • PBMCs peripheral blood mononuclear cells
  • An activation of the subject's immune system elicits a natural response providing the lesion site and other areas of immune neuroendocrine regulation with the necessary cells, cytokines, angiogenic, osteogenic and neural growth factors, hormones and other i munomodulators which bring about the therapeutic healing of lesions such as bums, venous and arterial leg ulcers, pressure ulcers, chronic infected wounds internal or external areas with inadequate blood perfusion such as viable but unde ⁇ erfused myocardium and the like, muscle loss, bone fractures, partial denervation, painful inflamed soft tissue, and other skin lesions.
  • the electromagnetic fields (EMFs) of this invention comprise time-varying magnetic fields, i.e. alternating currents that oscillate at specified frequencies.
  • the alternating currents are generated in a solenoid with frequencies that range from a few Hertz (more than about 1 cycle per second), about 10 Hertz, about 50 Hertz to about 100 Hertz, about 200 Hertz, about 300 Hertz, with maximum intensities around 120 Hertz and its harmonics. See Figure 5 of this patent.
  • These time varying magnetic fields have small static magnetic fields associated to them from a few microTeslas, e.g. about 2-5 ⁇ T, about 10 ⁇ T, to about 100 ⁇ T, about 0.3, about 0.8 mT.
  • Strong static magnetic fields with an intensity of about 40, about 50 to about 60 ⁇ T, about 70 ⁇ T, about 80 mT (400 to 800 gauss), are generated by the motion of electrons around atoms and of electrons in crystal lattices within the permanent magnets of this invention placed around the solenoid.
  • the present method attains healing of a wounded tissue either directly or through immune cells or other exposed tissues or through cell's products, and affords a reduction of pain, edema and infection while restoring or stimulating the subject's immune- mediated signaling network which is necessary to increase angiogenesis, vasculogenesis and wound repair.
  • PBMCs When a body part such as the arm or the whole body is exposed to the ENTs of this invention, PBMCs as well as other tissues such as the skin, muscle, blood and lymphatic vessels, erythrocytes, bone, nerve and extra cellular matrix, are under the EMFs effects of this invention. Under these conditions the tissues simultaneously exposed, could be stimulated to secrete products that act at a distance in the wound, in the unde ⁇ erfused tissue, in the partially denervated area, in bone fracture healing or in the immune neuroendocrine centers contributing to the regulation of wound repair. 6
  • the present invention thus, relates to a method of treating a body lesion associated with pain, edema, inflammation, bone fractures, partial denervation and/or infection, impaired wound repair and/or unde ⁇ erfused tissue such as viable but unde ⁇ erfused myocardium and the like, inadequate blood perfusion at the site of the lesion, and/or who exhibit an impaired immune-mediated inflammatory response and wound repair process which comprises applying to a subject afflicted with a lesion, externally and non-invasively and at a site removed from the lesion, analgesic, angiogenic, vasculogenic, nerve growth, anti-edema and wound repair effective electromagnetic fields (EMFs) comprising frequencies of a few Hertz, preferably about 0.1 Hz, about 1 Hz, about 5 Hz, about 10 Hz, about 20 Hz, about 60 Hz, about 80 Hz, about 100 Hz, about 120 Hz to less than about 180 Hz, about 240 Hz, about 300 Hz, and static magnetic field components having a
  • EMFs may be used alone or in combination with a static magnetic field of about 40, about 50 to about 70, about 80 mT (or about 400, about 450, about 500, about 550 Gauss to about 600, about 650, about 700, about 800 Gauss).
  • the EMFs may be applied to a limb of the subject, that is to an arm or a leg, and in some instances to a hand or a foot, to other parts of the subject's body, or to the whole body.
  • the present method may be conducted for various periods of time, including about 5 minutes to about 7 hours per administration.
  • the electromagnetic fields (EMFs) administration is conducted over a period of time effective to expose the subject's entire blood volume at least once to the EMFs. This procedure ensures that the entire blood volume is exposed to the EMFs and the inductive effect imparted to all cells present in the blood stream, particularly activated and memory peripheral blood mononuclear cells, and their progenitor cells.
  • the electromagnetic fields (EMFs) may suffice, the application may be repeated as many times as necessary. Preferably once a week, twice a week, 3, 4, 5, 6, and 7 times a week and up to about 1, 2, 3, 4, 5, 6, 7 and 8 weeks, and even several months and years.
  • the method also includes the periodic reapplication of EMFs.
  • the method of this invention may be applied to the treatment of diseases and conditions associated with and/or caused by, and/or resulting in, a body lesion(s).
  • a sufficient number of applications of the electromagnetic fields (EMFs) maybe delivered until the lesion is alleviated and/or fully healed.
  • EMFs electromagnetic fields
  • the lesions that may be treated with the present technology are chronic wounds, partial denervation, loss of muscular tissue, bone fractures, bums, lesions caused by inadequate blood perfusion, such as viable but unde ⁇ erfused myocardium and the like, consequences of unsuccessful surgery, and different types of venous, arterial and vascular problems, including arterial and venous ulcers. Examples of various lesions and their descriptions are provided below as well as the various other treatments presently available and their degree or lack of success in overcoming the diseases and conditions.
  • CHRONIC VENOUS AND ARTERIAL LEG ULCERS I. Chronic Venous Leg Ulcers Initially, chronic venous leg ulcers are generally caused by venous insufficiency and valve incompetence that lead to increased ambulatory pressure. This effect extends, in most cases to small veins, venules and capillaries. The pressure results in augmented interendothelial spaces, which, in turn, enhance extravasion of small solutes, macromolecules and blood cells. This is seen as a leakage of small and large molecules as well as blood cells out of the endothelial tissues and into the interstitial space. Concurrent with this, lymphoangiopathy and reduced lymphatic drainage are seen, which result in fall clinical edema.
  • Atherosclerosis of the lower limbs is the first cause of arterial leg ulcers and it leads to a progressive narrowing of the arterial lumen and a gradual reduction of blood flow to the distal circulation.
  • the atherosclerotic lesions generally extend.
  • the blood flow becomes sufficiently reduced and the perfusion pressure of nutritional capillaries uneven, insufficient nutritional support of peripheral microcirculation ensues.
  • an increase in leukocyte adhesion, platelet aggregation, Theological alterations and arteriolar microthrombi are observed. These contribute to further reducing the number of perused capillaries.
  • the described arterial alterations are expressed clinically as rest pain, throphic skin changes and ulceration. In addition, these lesions often get infected. ⁇ .l Chronic Arterial Leg Ulcer Treatment
  • a most common treatment starts with the repositioning of the patient to avoid prolonged pressure in any specific area of the body.
  • the basic treatment procedures commonly applied to these patients are general wound care and treatments aimed to control the basic disease.
  • the patients are also advised on adequate nutritional habits and recommended to take supplements of ascorbic acid, zinc, and selenium.
  • Chronic Wounds In most cases of chronic wounds, inadequate nutritious blood supply, edema, tissue anoxia, cell death and infection, reinforced by aging and sustained stress, reduce peptide signaling among cells involving growth factors, hormones and the like as well as their effects in the immune- neuroendocrine communication network. Healing is impaired due to the absence of a normal immune-mediated inflammatory response and/or repair process. The presently available treatments are only partially effective and the long-term prognosis is poor for these patients. The present status emphasizes the need of new methods to treat chronic wounds such as activating the cell's and cytokine' s signaling language necessary for wound repair, nerve growth, vasculogenesis and angiogenesis.
  • V. Myocardial Infarction Atherosclerosis is a generalized disease responsible for occlusive arterial disease such as lower-limb arterial disease (chronic arterial leg ulcers), myocardial infarction and stroke.
  • the etiologic factors (arterial hypertension, high serum cholesterol, smoking, stress, diabetes mellitus) are similar in these diseases.
  • Most deaths in patients with myocardial infarction are caused by arrythmias, infarct expansion and post-infarction remodeling.
  • Preventive measurements are focused to eliminate or control the etiological factors.
  • Reduction of early mortality of myocardial infarction can be achieved by the use of B-blockers, thrombolytic therapy followed by catheter based revascularization, angioplasty with or without stenting, by-pass surgery, angiotensin converting enzyme inhibitors and aspirin.
  • angiogenic growth factors are a novel approach still under clinical investigation.
  • PBMCs and cytokines play a central role.
  • Current treatment includes surgery, fixation and locally applied electromagnetic fields to induce osteogenesis.
  • V ⁇ Spinal Muscular Athrophies
  • the spinal muscular athrophies of infancy and childhood are diseases in which there is a progressive degeneration of the motor neurons of the spinal cord, with early age of onset and genetic determination. Although clinically resembling muscular dystrophies, in these patients the muscular atrophy is secondary to nerve degeneration. Some infants develop normally for several months before weakness become apparent. The trunk, pelvic and shoulder girdle muscle groups are disproportionally affected. The disease mns a steadily downhill course, and most patients have a short period of life. A few may survive for several years, and even are able to work with support. At the present time there is no cure for these diseases. Treatment is restricted to rehabilitation therapy and orthopaedic support. New approaches to nerve regeneration are neurothophic factors, Schwann cells manipulation, and locally applied electric currents or electromagnetic fields to induce electric currents, although these treatments are not used to treat spinal muscular atrophies.
  • Types of diseases and conditions which are normally associated with body lesions are, for example, partial denervation, tissue loss, bums, bone fractures, ischemic and traumatic lesions, chronic wounds and ulcers.
  • diseases and conditions have been observed to fall in the above described categories: diseases and conditions accompanied by inadequate blood perfusion such as viable but unde ⁇ erfused myocardium and the like, tissue necrosis, pain, edema and infection, such as internal and external chronic wounds, produced by atherosclerosis, arterial hypertension, diabetes, vasculitis, venous insufficiency, varicose veins, deep vein thrombosis, rheumatoid arthritis, prolonged immobility obesity, vascular necrosis, chronic wounds and aggravated bums, lesions produced by trauma, bums and surgery.
  • the present treatment is particularly suitable for application to conditions where nutritious blood supply and tissue regeneration is needed such as skin, muscle, nerve and connective tissue including, but not limited to viable but unde ⁇ erfused myocardium, ulcers such as venous ulcers, arterial ulcers, decubitus ulcers, deep pressure ulcers, medial malleolus ulcers, factitial ulcers, ulcers produced by trauma and surgery and lower limb ulcers, spinal muscle atrophy, among others.
  • the lower limb ulcers are individually or collectively located on different areas of the subject's leg or foot. Wounds that are treatable with the present method are of surgical or non-surgical origin.
  • Common non-surgical wounds are viable but unde ⁇ erfused myocardium, chronic venous and arterial leg ulcers, pressure ulcers and the like and common surgical wounds are wounds associated with or caused by surgery, silicon implants or by a surgical drainage.
  • Typical diseases and conditions associated with or causing inadequate blood perfusion are for example: atherosclerosis, venous insufficiency, deep vein thrombosis venous and arterial hypertension, vasculitis, diabetes, rheumatoid arthritis, obesity, and diseases associated with long periods of inactivity, such as those occurring when a subject sits or lies down for an extended period of time.
  • the present method is also suitable for increasing the effect of a treatment applied to a body lesion associated with pain, edema and/or inflammation.
  • a patient on whom a treatment was previously ineffective is made to respond to the same treatment upon a series of electromagnetic fields (EMFs) applications.
  • EMFs electromagnetic fields
  • the present method does, in this manner, increase the subject responsiveness to the treatment, which, in turn, results in alleviation of the body lesion and the pain, edema and/or inflammation accompanying it.
  • the present method is of particular value where a subject had become resistant to the agent for treating the disorder or condition, and the application of the electromagnetic fields (EMFs) restores the ability of pharmaceutical or surgical treatments to improve the subject's health and mobility.
  • EMFs electromagnetic fields
  • Examples of such treatments are angioplasty, surgery, saphenectomy, skin grafts, wound closure, stitching, bandaging, anti-hypertensive therapy, pharmaceutical composition administration, nursing care and body lesion clean up, among others.
  • compositions which are typically administered to patients afflicted with the sort of lesions described above are pain killers, anti-inflammatory agents, antibiotics, flavinoids, tissue plasminogen activator, aspirin, prostacyclin analogs, prostanoids, venotonic drags, fibrinolytic and thrombolytic agents, diets and the like. These agents may also be administered in conjunction with or subsequent to the administration of EMFs in accordance with this invention.
  • the preferred embodiments of the invention will now be described with reference to the drawings in so far as this may facilitate the understanding of this invention.
  • the present treatment may be applied with the apparatus of the invention exemplarily illustrated in Figures 1-2, 8-9, 10-11, 14-15, 17-18, 19-20, 22-23 and 25-26.
  • FIG. 1-9 illustrate the use of time-varying magnetic fields in combination with static magnetic fields.
  • Figures 8 and 9 illustrate an enlarged embodiment of this invention which has a large enough internal chamber to expose a large part of part of a human body such as the torso.
  • the permanent magnets are eliminated but the time-varying electromagnetic fields are maintained. See, Figures 10 to 16.
  • Another embodiment provides an apparatus similar to the one previously described but equipped with a large enough internal chamber to expose a part of the human body, e.g. from the upper limit of the aorta to the lower limit of the liver and spleen, inside the chamber to the magnetic field. See, Figures 17 and 18.
  • time-varying magnetic fields of the same characteristics can be applied to the patient's large blood and lymph vessels: aorta, vana cava and thoracic duct, as well as to the large blood and lymph reservoirs: heart, lung, liver, spleen, and paravertebral ganglia.
  • This treatment simultaneously exposes large numbers of peripheral blood mononuclear cells to the electromagnetic fields, and reduces treatment time.
  • These embodiments of the apparatus were designed to provide a comfortable position for the patient during exposure to the magnetic fields.
  • the characteristics of the time- varying magnetic fields are the same as in the above-described apparatus but are generated by, for example, two parallel coils, i.e. Hemholtz coils.
  • the coils produce homogeneous electromagnetic fields in the center between them.
  • This embodiment can be used to expose part of the human body lying on a bed to the time varying magnetic fields. See, Figures 19-22.
  • Yet another embodiment provides a slight variation of the apparatus described above, but where similar equipment is placed upside down and fixed-to the sides of a narrow bed made of non magnetic material.
  • the magnetic flux produced by the coils now runs pe ⁇ endicular to the body axis.
  • the controls may be easily located at bedside, as shown. See, Figure 23.
  • FIG. 25 to 28 Another embodiment of the present apparatus is provided with coils arranged in a saddle disposition so the magnetic fields run pe ⁇ endicular to the limb.
  • This equipment was built for veterinary applications and has been successfully used to cure an inflamed joint and skin wound of a horse. However, it may also be used in humans. See, Figures 25 to 28.
  • the electromagnetic fields of this invention may be generated in two different manners.
  • One manner is where the electromagnetic fields are generated by modulating continuous about 27.12 Mhz waves that transport electrical and magnetic energy through space (transporting wave) at the same or similar frequencies of the present invention (i.e.: an antenna to focus the electromagnetic fields of the present invention in any direction).
  • the other way is by modulating electromagnetic fields of high intensity and frequency (transporting waves) such as those electromagnetic fields produced by a Tesla coil, to the same or similar frequencies as employed in the present invention.
  • the electromagnetic fields traveling through space may reach a patient lying in bed or seated without being attached to the apparatus.
  • an embodiment of the apparatus of the present invention may be in the general form of a rectangular or square box 101, which may be fabricated from wood, plastic or other non-magnetic material to prevent interference with the application of an electromagnetic field to a patient's body part.
  • the front or face panel 103 of the apparatus may have generally a circular opening 104 which extends as a elongated annular passageway 105 in the box 101.
  • the passageway 105 generally extends horizontally inside the box 101, and when not in use, it may be closed and has an end 109 at the rear wall or panel 111.
  • a timer 113 and a control mechanism 115 are connected to an electronic panel 117, for varying and controlling the intensity and duration of the magnetic field(s).
  • a solenoid coil 119 for supplying a time-varying magnetic field.
  • Figure 6 shows the permanent magnets 121 for supplying the static magnetic field.
  • an electric current is supplied from an AC power source (not shown) through power lines 123, 125, and into a transformer 127 and a rectifier bridge 129 to the magnetic coil 119.
  • the manner and details for supplying electric current to the solenoid are well known in the art, and are not per se critical in this invention.
  • FIG. 8 and 9 another embodiment provides an apparatus similar to the one described in the previous paragraph.
  • This embodiment is an enlarged version of the embodiment shown in Figures 1 to 7.
  • This second embodiment allows exposure to a part or the whole body to the EMFs as shown in Figures 8 and 9.
  • the major blood vessels aorta, cava veins
  • paravertebral lymph nodes and major blood reservoirs (liver, spleen, lung and heart) can be exposed simultaneously to the combination of time- varying magnetic fields and static magnetic fields (not shown), reducing the patient exposure time.
  • This apparatus has a circular shaped housing 130 containing the coil 119 and strong permanent magnets 121.
  • the circular shaped housing 130 has an internal chamber 132 large enough to expose part of the body of a patient 134 to the magnetic field.
  • the housing 130 may be fixed to a narrow bed 136 made of non-magnetic material.
  • the timer 113 and control mechanism 115 connected to an electronic panel, as in the previous embodiment, may be located at the side of the bed.
  • the housing is made from a non-magnetic material such as wood or plastic.
  • this embodiment also includes a coil support 250 for supporting the coil 119 and a tube wall 252.
  • a solenoid such as a magnetic coil 157
  • the cylindrically shaped housing 158 includes an elongated annular passage 159 formed therethrough.
  • the magnetic coil 157 is disposed within the cylindrically shaped housing 158 and around the annular passage 159.
  • the housing and the annular passage are sized to comfortably accommodate the limb of a patient, such as the forearm 160 or upper arm 162 of a patient, allowing more mobility to the patient while being exposed to the EMFs.
  • the cylindrically shaped housing is made of a light non-magnetic material.
  • non-magnetic materials include plastic or wood.
  • the transformer 127 and rectifier bridge 129 (shown in Figure 7), along with a pair of contacts 152 which are connectable to a power source, are contained within a small adapter box 150, to readily obtain electric current from an AC power source (not shown).
  • the adapter box 150 with the contacts, the transformer, and the rectifier bridge contained therein, is connected to the coil 157 by two long cables 154 which provide current to the coil 157.
  • FIG. 17 and 18 another embodiment provides an apparatus similar to the embodiment shown in Figures 10 to 13.
  • This embodiment is an enlarged version of the embodiment shown in Figures 10 to 13.
  • This embodiment allows a part or the whole body to be exposed to the EMFs as shown in Figures 17 and 18.
  • the major blood vessels aorta and cava veins
  • thoracic duct paravertebral lymph nodes
  • major blood reservoirs liver, spleen, lung and heart
  • This apparatus has a circular shaped housing 260 containing the coil 119 and includes an internal chamber 262 large enough to expose part of the body of a patient 204 to the magnetic field.
  • the housing 260 may be fixed to a narrow bed 245 made of non-magnetic material.
  • the timer 113 and the control mechanism 115 connected to an electronic panel, may be located at the side of the bed.
  • the housing is made from a non-magnetic material such as wood or plastic.
  • a magnetic field may also be applied with another embodiment illustrated in Figures 19 and 20.
  • This apparatus may be in the general form of a U- shaped housing 200. Referring to Figure 22, part of the body of a patient 204 may be exposed to a homogeneous electromagnetic field in accordance with this invention between the lateral walls 208 of the housing 200 of the apparatus.
  • the apparatus may be fabricated from wood, plastic, or other non-magnetic material, to prevent interference with the application of an electromagnetic field to a patient's body part.
  • installed on the face panel 212 are a timer 214 and a control mechanism 216, both of which are connected to an electronic panel 218 shown in Figure 20, for varying and controlling the intensity and duration of the electromagnetic field(s).
  • FIG. 20 disposed on each interior of the lateral walls 208 is a coil 224 for supplying time-varying magnetic fields.
  • the lateral walls serve as supports to maintain the coils in a Helmholtz disposition.
  • Figure 21 shows a schematic representation of the electromagnetic flux generated by the opposed Hemholtz coils 224.
  • an electric current is supplied from an AC power source (not shown) through power lines 230, 232 and into a transformer 234 and a rectifier bridge 236.
  • a capacitor 238, and resistors 240 are used to reduce the effective current to the magnetic coils 224.
  • a fan is used to cool the resistors.
  • FIG. 23 A slight variation of this embodiment is shown in Figure 23.
  • similar equipment is used, but the housing 200 is turned upside down and fixed to the sides of a narrow bed 245 made of non-magnetic material.
  • the magnetic flux produced by the coils now runs pe ⁇ endicular to the axis of the body 204.
  • the timer and control mechanism 214 and 216 may be easily located at the side of the bed.
  • Figures 25 and 26 Another embodiment of the apparatus of this invention is illustrated in Figures 25 and 26.
  • the apparatus may be in the general form of a saddle 280.
  • the saddle may be placed on a limb or a body part 282 to expose a patient to the homogeneous electromagnetic field in accordance with this invention.
  • the apparatus may be fabricated from wood, plastic or other nonmagnetic material to prevent interference with the application of an electromagnetic field to a patient's body part.
  • the saddle is connected through electric cables 288 to the control unit 290 which contains a timer 292 and a control mechanism 294, both of which are connected to an electronic panel (not shown) for varying and controlling the intensity and duration of the electromagnetic field(s).
  • the coils 298 for supplying the time-varying magnetic field.
  • Figure 24 the same circuit as used in the previous embodiment, Figures 19 to 23, can be used to deliver current to the coils 298 of the current embodiment illustrated in Figures 25 to 28.
  • An electric current is supplied from an AC power source (not shown) through power lines 230, 232 and into the transformer 234 and the rectifier bridge 236.
  • a capacitor 238, and resistors 240 are used to reduce the effective current to the magnetic coils 298 and a fan is used to cool the resistors.
  • the manner and details for supplying electric current to the coils are well known in the art, and are not per se critical in this invention.
  • the electromagnetic fields of this invention may be generated.
  • One is by modulating a continuous 27.12 MHz waves that transport electrical and magnetic energy through space (transporting waves) at the same frequencies of the present invention (i.e. an antenna to focus the electromagnetic fields of the present invention in any direction), and the other by modulating to the same frequencies of the present invention the electromagnetic fields of high intensity and frequency produced by a Tesla coil, (transporting waves).
  • the electromagnetic fields of this last design travel through space so a patient lying in bed or seated to a nearby source may be treated without seeing the apparatus.
  • the patient's limb e.g. a hand or part of an arm
  • the power source is then turned on to supply an electric current to the solenoid coil 119.
  • the lines of flux produced by the magnetic fields generated within the space 107 are shown in Figure 3, and are seen to comprise variable as well as static magnetic flux lines. It has been found that the treatment is most effective when the electromagnetic field is applied at extremely low frequencies of more t hn one Hertz to less than about 300 Hz. The frequencies spectral content of the time-varying magnetic field are higher around approximately 120 Hz and its harmonics.
  • These frequencies have a static magnetic field component with an intensity of about 0.3 to about 0.8 mT root mean square (rms) and these EMFs can be used alone or in combination with a homogeneous static magnetic field of about 40 to about 80 mT (about 400 to about 800 Gauss).
  • rms root mean square
  • PBMCs peripheral blood mononuclear cells
  • the magnetic fields are preferably applied to the patient's limb for about several minutes to about eight hours.
  • the preferred exposure time was calculated so that a blood volume equivalent to the patient's entire blood volume is exposed to the magnetic field at least once.
  • the exposure frequency may be varied from a maximum of about 30 minutes to about seven hours a day, to a minimum of about 30 minutes a week, depending on the observed lesion repair and wound healing observed.
  • PBMCs peripheral blood mononuclear cells
  • Example 1 In Vitro Effects of Different Electromagnetic Fields on PBMC Proliferation
  • Peripheral blood mononuclear cells PBMCs
  • the fraction containing PBMCs was washed 3 times and resuspended in phosphate buffered saline to a final concentration of 5 x 10 6 cells/ml.
  • PBMCs aliquots 0.2 ml aliquots of 5 x 10 6 cells/ml, plus l ⁇ m/ml of phytohemaglutinin were placed in Eppendorf tubes. Four subsets were formed (three tubes per subset). The first subset was shielded from the magnetic fields.
  • Subset 2 was exposed to the combination of time- varying electromagnetic fields and static magnetic fields in accordance with this invention
  • Subset 3 was exposed only to the time-varying electromagnetic fields in accordance with this invention
  • Subset 4 was exposed only to the static magnetic field in accordance with this invention.
  • Four subsets were prepared without phytohemaglutinin (controls) and placed under the same experimental conditions. All tubes were incubated at 37 °C in a C0 2 humidifier incubator (Forma Scientific Mod 3325
  • electromagnetic fields cross biological tissues, they also produce in vivo effects on circulating PBMCs.
  • the in vivo effects of the time varying electromagnetic fields of this invention, alone or combined with the static magnetic fields, are observed in chronic skin wounds even after only about thirty minutes to one hour of exposing a body part situated far from the lesion site to the EMFs of this invention. In this period of time, it is common to observe the drying of a lesion and a reduction of its diameter.
  • Electromagnetic stimulation as defined below was applied in the arm two to three hours a day, several times a week, or a period of two to eight months. All exposed tissues of the arm were considered under the combined effect of the static and/or time variable magnetic fields. The intensity of the induced variable electric fields in each segment of the arm varied with the radius according to
  • This group included patients whose underlying afflictions were, in addition to the leg ulcers, primary varicose veins, deep vein thrombosis, diabetes, hypertension, rheumatoid arthritis, obesity and cardiovascular disease among others. Pain, edema infection and limited mobility, which accompanied the leg ulcers.
  • Patient No. 1 is a 75 year old woman afflicted with primary varicose veins and had a 6 cm 2 leg ulcer for over 9 months. The ulcer was accompanied by pain, edema and limited mobility. Electromagnetic stimulation in accordance with the invention was then applied to one of her arms for about 2 hours/day 5, days/week over a period of 5 months. No other treatment was administered during this time.
  • Patient No. 2 is a 33 year old man afflicted with primary varicose veins, who had a 4 cm 2 leg ulcer for over 9 months, which was accompanied by pain and edema. Electromagnetic stimulation in accordance with this invention was applied to his arm for about 2 hours/day 5 days/week for a period of 1 week in the absence of additional treatments. One week after initiation of the treatment, the pain and edema disappeared and the ulcer appeared completely healed, 6 weeks later, however, when the patient returned to the hospital, he had a new leg ulcer in all appearances produced by trauma, not by reoccurrence.
  • Patient No. 3 is a 66 year old woman that was afflicted with primary varicose veins and had a 6 cm 2 leg ulcer for over a year. The ulcer was accompanied by pain, edema, and limited mobility.
  • the only treatment she received was electromagnetic stimulation, applied to one of her arms 2 hours/day, 3 days/week for a period of 3 months. After the first 2 weeks of treatment, the pain and edema disappeared and the patient became fully mobile. The treatment enhanced the growth of granulation tissue and reduced the ulcerated area on her leg by about 48 % , 3 months after treatment began.
  • Patient No. 4 is a 38 year old woman, afflicted with deep vein thrombosis for over 8 years and had a 6 cm 2 leg ulcer for over 7 years.
  • the ulcer was accompanied by pain, edema and limited mobility.
  • the patient was given medical and surgical treatment, including saphenectomy and skin graft procedures, as well as the application of an ambulatory pressure bandage to the ulcer, but they were ineffective in improving her condition.
  • Electromagnetic stimulation in accordance with this invention was then applied to one of her arms 2 hours/day, 5 days/week for a period of over 5 months. During this time the patient continued to use her loose ambulatory bandage on the leg ulcer she used before the electromagnetic therapy.
  • Example 7 Middle Aged Female with Deep Vein Thrombosis and Superficial Venous Insufficiency
  • Patient No. 5 is an obese 41 year old woman, afflicted with deep vein thrombosis and superficial venous insufficiency, with chronic leg ulcers for over 7 years in both lower limbs.
  • the ulcerated areas were accompanied by pain, edema, itching and limited mobility.
  • she received local and systemic medical treatment, as well as phlebotomy with Litton technique in both legs which were ineffective in improving her condition.
  • Electromagnetic stimulation was then applied to one of her arms for 2 hours/day, 3 days/week. After the first two weeks of treatment pain and edema disappeared and in two months the ulcers were completely healed and EMFs exposure was suspended. Four months later, the ulcers remained healed and the patient was asymptomatic.
  • Example 8 Middle Aged Female with a Deep and Superficial Venous Insufficiency and Arterial Hypertension
  • Patient No. 6 is an obese 59 year old woman, afflicted with deep and superficial venous insufficiency and arterial hypertension, with a chronic leg ulcer for over one and a half years.
  • the ulcer was accompanied by pain, edema, a big area of erythema and limited mobility.
  • arterial hypertension was kept under control and the ulcer was treated with conventional medical and surgical treatments which were ineffective in improving her condition.
  • the electromagnetic stimulation was then applied to one of her arms for 2 hours/day, 3 days/week for about 2 months while she continued to take the same anti- hypertensive treatment as before. After the first two weeks of electromagnetic therapy pain and edema disappear and in three weeks the ulcer was covered by scab. The area of erythema was reduced in four weeks and the scab began to fall being substituted by scarred tissue.
  • Example 9 Female with Lymphatic and Superficial Venous Insufficiency
  • Patient No. 7 is a 42-year-old female afflicted with lymphatic and superficial venous insufficiency caused by a bum on her left leg, which occurred when she was 2 years old.
  • she had an extensive ulcerated area on her leg totaling 395 cm 2 , which was accompanied, by pain, edema and limited mobility.
  • she had received compressive ambulatory bandage, medical and surgical treatments, including skin grafts, which were ineffective in improving her condition.
  • Electromagnetic stimulation was then applied to one of her arms for 2 hours/day, 5 days/week for a period of over 6 months in accordance with the invention. During the course of this therapy, she continued to use the loose, compressive ambulatory bandage, which she used before electromagnetic therapy. No other additional treatment was administered to her. After 2 weeks of electromagnetic treatment, the pain and edema disappeared, and after 4 to
  • Example 10 Female with Superficial Venous Insufficiency
  • Patient No. 8 is a 52 year old woman with superficial venous insufficiency who had a 7 cm 2 leg ulcer for over 7 years. The ulcer was accompanied by pain, edema, infection and limited mobility.
  • the electromagnetic stimulation was applied to one of her arms for about 2 hours/day, 3 days/week over a period of two months. No other treatment was administered during this time.
  • Patient No. 9 is a 62 year old woman afflicted with superficial venous insufficiency and a chronic leg ulcer which opened and closed for over 15 years. A week before admission to the study the ulcer scar became very painful producing a 0.5 cm 2 ulcerated area with serum exudatc. The electromagnetic stimulation was then applied to one of her arms for about 2 hours/day, 3 days/week for two weeks. The ulcer healed in three days and the patient remained asymptomatic during the following month.
  • Example 12 Middle Aged Female with Superficial Venous
  • Insufficiency Factitial Ulcer and Mental Depression Patient No. 10 is a 51 year old, mentally depressed woman who had two leg ulcers of approximately 25 cm 2 that were artificially maintained open by the patient for over 21 years. The lesions were accompanied by pain, edema and limited mobility. During that time the patient had been given medical treatment but it was ineffective in treating her condition. Electromagnetic stimulation in accordance with this invention was then applied to the patient's arm 2 hours/day, 3 days/week for a period of two months. No other treatment was administered to her during this time.
  • This group includes patients whose underlying afflictions are, in addition to the chronic leg ulcers and venous disease, non pitting edema, obesity with very high body mass index (more than 40 kg/M 2 ) and dioderma gangrenosum among others. Pain, edema and infection accompanied the chronic leg ulcers.
  • Example 13 Superficial and/or Deep Venous Insufficiency, Non-pitting Edema, Obesity & Chronic Venous Leg Ulcers
  • This example describes treatment to a group of four patients.
  • the patients (Patients Nos. 11-14) are one woman and three men 56 to 71 years old afflicted with superficial and/or deep venous insufficiency, brawny edema, obesity and chronic venous leg ulcers for a period of 9 to 17 years. All patients had been with preventively treated with present recommended medical treatments, and surgery intended to alleviate venous hypertension and/or to cover the ulcerated areas with skin grafts. All these treatments were ineffective to improve their condition.
  • Electromagnetic stimulation in accordance with this invention was then applied to each of patients 11 to 14 on either arm 2 hours/day, 3 days/week. Two weeks after the initiation of EMFs treatment, pain was reduced and the ulcers look dried and deep. These changes improved patient's condition for a while, however the size of the ulcers remained the same and in some cases increased their size during the EMFs treatment period. These patients were eliminated from the protocol.
  • Example 14 Female with Severe Superficial Venous Insufficiency, Obesity with High Body Mass Index & Chronic Venous Leg Ulcer Patient No. 15 is a 46 year old woman afflicted with superficial venous insufficiency since she was 13 years old, obesity with very high Body Mass Index (more than 40 k g/M2 ) and a painful large chronic venous leg ulcer in her left leg for a period of over 4 years. During that time, she received preventive measurements and recommended medical treatments in specialized centers without improving her condition. Electromagnetic stimulation in accordance with this invention was then applied to one of her arms 2 hours/day, 3 days/week, for a period of four months.
  • Patient No. 1 is a 46 year old woman afflicted with deep vein thrombosis and two atypical ulcers located in the posterior part of her right leg for a period over 4 years. During that time, she received preventive measurements and recommended medical treatments in specialized centers without improving her condition.
  • Electromagnetic stimulation in accordance with this invention was then applied to one of her arms 2 hours/day, 3 days/week, for a period of four months. Two weeks after the initiation of
  • EMFs treatment pain was reduced and one of the ulcers became superficial. After that point the ulcers began to grow and the patient was eliminated from the protocol. A skin biopsy revealed changes compatible with Piodernia Gangrenosum the patient was medically treated.
  • This group consists of patients whose underlying afflictions, in addition to the chronic arterial leg ulcers, were generalized atherosclerosis, diabetes, arterial and/or venous hypertension, rheumatoid arthritis, obesity, cardiovascular disease and vascular necrosis, among others. Rest pain, edema infection and limited mobility accompanied the leg ulcers.
  • Patient No. 17 is a 73 year old woman, afflicted with 3 arterial ulcers and diabetes, who had a 22 cm 2 ulcerated area on her left leg for over 4 months accompanied by intense pain that )revented the patient from sleeping at night. During that time she received medical treatment, but it was ineffective in improving her condition.
  • Electromagnetic stimulation in accordance with this invention was then applied to one of her arms for 3 hours/day, 4 days/week for a period of over 7 months. No other treatment was aclministered during this time. After 4 weeks of treatment, the skin temperature increased and the superficial veins became more noticeable reflecting increased vasculogenesis. The ulcer bottom display abundant granulation tissue reflecting increased angiogenesis. Pain was greatly reduced allowing the patient to sleep at night. After 7 months of electromagnetic treatment the three ulcers were completely healed. During this time the mental alertness and memory of the patient improved significantly. This patient was followed for an additional year. During this time the ulcers remained healed.
  • Patient No. 18, is an 80 year old woman afflicted with two arterial ulcers associated with rheumatoid arthritis and atherosclerosis.
  • the ulcerated area was approximately 35 cm 2 produced by elastic stockings after knee surgery. These lesions remained open for 19 months and were accompanied by intense pain that kept the patient awake at night. Skin grafts and pharmacological treatments were ineffective in improving her condition.
  • Electromagnetic stimulation in accordance with this invention was applied to one of her arms for three hours/day, 3 days/week, for a period of 4 1/2 months. No other treatment was administered during this time.
  • Patient No 19 is a 70 year old man afflicted with a two year old chronic arterial ulcer 65 cm 2 , caused by generalized atherosclerosis on the anterior part of his leg.
  • the femoral artery lumen was 85% reduced and the anterior tibial artery lumen had 90% stenosis.
  • the ulcer was accompanied by intense pain that kept the patient awake at night. Skin grafts and pharmacological treatments were ineffective in improving his condition.
  • Electromagnetic stimulation in accordance with this invention was applied to one of his arms for three hours/day, 3 days/week, for a period of 12 months. No other treatment was administered during this time. After two weeks of treatment the ulcer bottom was red and the tendon was epithelialized, pain was greatly reduced allowing the patient to sleep at night and mobility was improved. Two an a half months after the skin temperature increased and the superficial veins became more noticeable reflecting increased vasculogenesis. The ulcer bottom display abundant granulation tissue reflecting increased angiogenesis and the patient was without pain. During this time the patent became more optimistic, alert and his mood improved significantly. The overall reduction of the ulcerated surface area on his leg brought about by 12 months of treatment was about 80%.
  • Example 19 Female with Generalized Atherosclerosis, Superficial & Deep Venous Insufficiency & Rheumatoid Arthritis
  • Patient No. 20 is a 57-year-old woman afflicted with generalized atherosclerosis, superficial and deep venous insufficiency and rheumatoid arthritis. Additionally, she had two 9 month old ulcers. One ulcerated area 6.5 cm 2 on the front part of her leg, and the other a 1 cm 2 medial malleolus ulcer. Electromagnetic stimulation was then applied on one of the patient's arms, 3 hours/day, 4 days/week, for about 7 months. No other treatment was administered at this time.
  • the medial malleolus ulcer healed and the ulcer in the front part of her leg healed in seven months. During this time her depressive mood improved.
  • Patient No. 21 is a 45 year old woman afflicted with vascular necrosis of the right leg resulting from receiving a silicon implant. Reconstructive surgery saved her leg from amputation. Two years after, the use of a tight prosthesis lead to arterial occlusion in the posterior-medial area other leg, resulting in a very painful 23 cm 2 ulcer that lasted for over 5 months. Pain and edema accompanied the ulcer, and she had limited mobility. During that time she received medical treatment, but it was ineffective in relieving her condition. Before electromagnetic therapy was given to the patient, she required local anesthesia while her ulcer was cleaned. The electromagnetic stimulation was applied to her arm 1 hour/day, 5 days/week for a period of over 2 months, during which time her ulcer was cleaned daily. No other treatment was administered at this time.
  • Example 21 Middle Aged Male with Uncontrolled Arterial Hypertension & Deep Vein Thrombosis
  • Patient No. 22 is a 54 year old man, afflicted with uncontrolled arterial hypertension and deep vein thrombosis which had chronic leg ulcers totaling 20 cm 2 for over 7 years.
  • the ulcerated area was accompanied by pain, edema, and limited mobility.
  • Electromagnetic stimulation was then applied to one of his arms for 2 hours/day, 3 days/week for about 4 months while he continued to take the same anti hypertensive treatment as before.
  • Example 22 Female with Uncontrolled Arterial Hypertension, Superficial Venous Insufficiency, Controlled Type H Diabetes Mellitus & Obesity
  • Patient No. 23 is a 60 year old woman who had 2 leg ulcers totaling 11 cm 2 , one of which she had for over a year and the other for over 3 months. During that time she received medical treatment including anti-hypertensive therapy, but it was ineffective in improving her condition.
  • Electromagnetic stimulation in accordance with the present method was then applied on one of her arms for 3 hours/day, 3 days/week for a period of over 4 1/2 months, during which time she received a continuation of her anti-hypertensive treatment.
  • the patient developed a third lesion which was produced by trauma.
  • Example 23 Old Female with Generalized Atherosclerosis Patient No. 24 is an 85 year old woman afflicted with generalized atherosclerosis and a chronic leg ulcer 1.2 cm 2 for over one year. During that time she received the recommended medical treatment but it was ineffective in relieving her condition.
  • Electromagnetic stimulation in accordance with the present method was applied to one of her arms 2 hours/day, 5 days/week for a period of over 2 months. After two weeks of treatment the pain and edema disappeared. These changes were followed by a reactivation of the inflammatory reaction around the ulcer with an exuberant increase of granulation tissue that cover the ulcer bottom reflecting enhanced angiogenesis. In three months the ulcerated area was reduced by more than 70%.
  • Example 24 Young Male with Uncontrolled Type I Diabetes Mellitus & Hyper cholesterolemia
  • Patient No. 25 is a 24 year old man afflicted with uncontrolled Type I diabetes mellitus and hypercholesterolemia, afflicted with a three month old plantar ulcer on his left foot.
  • the patient received local surgical and medical treatments that were ineffective in relieving his condition.
  • the electromagnetic stimulation was applied to one of his arms 2 hours/day, 5 days/week for a period of over 2 months. After three weeks of treatment the deep ulcer base was at the level of the de ⁇ nis. The ulcer healed completely in four weeks. The patient was followed for an additional four months remaining asymptomatic.
  • This group includes patients whose underlying afflictions were, in addition to the pressure ulcers, paraplegia, deep vein thrombosis and obesity, among others. Pain, edema and infection accompanied the pressure ulcers.
  • Example 25 Middle Aged Incontinent, Paraplegic Female with Leg Wounds
  • Patient No. 26 is a 64 year old, paraplegic and incontinent woman who had 2 wounds.
  • Example 26 Old Female with Pressure Ulcer & Deep Vein Thrombosis
  • Patient No. 27 is an obese 90 year old woman who had an 18 month old, 60 cm 2 painful, edematous, bleeding, friable, pu ⁇ le, deep pressure ulcer on her left ischial tuberosity caused by her sitting in the same position for 8 to 12 hours/day while being afflicted with deep vein thrombosis.
  • Electromagnetic stimulation was then applied to one of her arms for 2 hours/day, 7 days/week for a period of over 5 months. She continued to receive local wound cleaning, but no additional treatment was given to her at this time.
  • CHRONIC WOUNDS This group included patients whose underlying afflictions were, in addition to the chronic wounds, peripheral arterial disease, intense stress and peritonitis, among others. Pain, edema and infection accompanied the chronic wounds.
  • Patient No. 28 is a 78 year old man who had a 126 cm 2 infected surgical wound after a long and complicated abdominal surgery.
  • Electromagnetic stimulation was applied to one of his arms 1 hours/day for 3 weeks. After 2 weeks of treatment the infection disappeared, and the wound was surgically closed because of granulation tissue and wound healing were under optimal conditions for this procedure.
  • Example 28 Old Man with Unhealed Surgical Wounds
  • Patient No. 29 is a 73 year old man with lower limb arterial disease associated with smoking, diabetes and generalized atherosclerosis. Chronic lower-limb ischemia had been present for years. Critical leg ischemia was evident in the last year and the patient was subjected to surgical re-vascularization. However, 3-1/2 months after the operation, the surgical wounds located in his left thigh and leg were not healed and the knee surgical wound remained an open 30 cm 2 wound. Electromagnetic stimulation in accordance with this invention was then applied to one of his arms 2 hours/day 3 days/week for a period of five months. No additional treatment was administered to him.
  • Patient No. 30 is a 65 year old woman with lower limb arterial disease associated with smoking. As a consequence of a trauma, a small braise developed into a 2.6 cm 2 infected, very painful ulcer, in two weeks causing reduced mobility. This wound was resistant to antibiotic treatment.
  • Electromagnetic stimulation in accordance with this invention was then applied to one of her arms 2 hours/day, 5 days/week in addition to a new antibiotic treatment. After two weeks the infection was controlled, edema and pain were drastically reduced and mobility became almost normal. The previously unhealed wound displayed abundant granulation tissue on the ulcer bottom. A week later the patient was asymptomatic and ulcer healed in less than one month since the beginning of EMFs treatment.
  • Example 30 Middle Age Male with an Infected Shoulder Wound
  • Patient No. 31 is a 57 year old man under intense stress who by scratching an old scar developed a 3 cm 3 very painful abscess in his left shoulder in two weeks. The lesion was controlled with antibiotics but two weeks later pain, edema, immobility and a 3 cm 2 open wound were still present.
  • Electromagnetic stimulation in accordance with this invention was then applied to one of his arms 2 hours/day, 5 days/week. Three weeks later, pain, edema and immobility disappeared and the wound was reduced by more than 70% . The ulcer healed completely two weeks later. v. ⁇ .ATED ISCHEMIC CARDIOMYOPATHY
  • This group includes patients with viable but unde ⁇ erfused myocardium, who were not candidates for coronary revascularization.
  • Atherosclerosis is a generalized disease responsible for occlusive arterial disease such as lower-limb arterial disease (chronic arterial leg ulcers), myocardial infarction and stroke.
  • the etiological factors (arterial hypertension, high serum cholesterol, smoking, stress, diabetes mellitus) are similar, as are preventive measurements (eliminate or control the etiological factors), and some treatments (angioplasty or by-pass when indicated).
  • the enhancement of the body's natural process of collateral blood vessel growth is a novel approach.
  • Therapeutic angiogenesis has been attempted using angiogenic growth factors. Acid and basic fibroblast growth factors have been successfully tested in animal models but positive clinical results have not been reported in clinical trials.
  • VEGF Vascular endothelial growth factor
  • Example 31 Young Male with Sequela of Anteroseptal Acute Myocardial Infarction
  • Patient No. 32 is a 40 year old man with sequela of anteroseptal acute myocardial infarction.
  • the patient was evaluated by clinical examination, blood tests, chest X-Ray, electrocardiogram, stress test, echocardiogram, coronary angiography, and cardiac ventriculography.
  • the observed lesions include anteroseptal myocardial infarction with extensive anterior and lateral sub-epicardic ischemia and left bundle anterior hemi- branch block.
  • Patient was classified as Functional Class III of the New York Heart Association (NYHA) being not candidate for coronary revascularization.
  • NYHA New York Heart Association
  • Electromagnetic force was then applied to one of his arms 2 hours/day, 3 days/week for a period of one month while continuing with the same medical treatment as before.
  • Example 32 Obese Women with Arterial Hypertension & Sequela of Three Month Old Acute Myocardial Infarction
  • Patient 33 is a 54 year old obese woman afflicted with arterial hypertension and sequela of a three month old Acute Myocardial Infarction (AMI).
  • AMI Acute Myocardial Infarction
  • Patient evaluation included clinical examination, blood tests, chest X-Ray, electrocardiogram, stress test, echocardiogram, coronary angiography, and cardiac ventriculography.
  • Lesions included Arterial Hypertension, elevated blood values of Glucose, Uric Acid, Triglycerides and Cholesterol. Anteroseptal and lateral subendocardic necrosis. Extensive anterior sub-epicardic ischemia. Right atrium enlargement. Coronary angiogram. reported occlusion of left descending coronary artery at its origin and 80% stenosis of circumflex.
  • Electromagnetic stimulation was then applied to one of her arms 2 hours/day, 4 days/week for a period of five months while continuing with her previous treatment.
  • This group included patients with no other underlying affliction.
  • This orthopaedic problem was selected to evaluate the benefits of the EMFs of this invention in reducing pain and edema in an acute problem as well as to observe if it could accelerate the healing process of a different type of internal wound, i.e. a bone fracture.
  • Example 33 Eight Patients with Ankle Fractures Type Weber A or B
  • This example presents information on a group of eight patients (patients 34 to 41).
  • the patients are two women and six men 19 to 65 years old, afflicted with uni or bi-malleolar ankle fractures type Weber A or B. All fractures were accompanied with intense pain, and edema. All fractures were treated with internal fixation. Compression of fracture surfaces was obtained with lag screws with or without semitubular compression plates. Surgical repair of the deltoid ligament was done when indicated. Sterile dressings were applied to the wounds and then a plaster splint to hold the foot in neutral position.
  • Electromagnetic stimulation was then applied to each patient on either arm 2 hours/day, 2-3 days/week for 10 sessions beginning the next day after surgery. Leg was maintained elevated and pain was controlled with Dipirone 500 mg 3/day.
  • This patient was selected as an example of nerve regeneration in a disease with no present treatment.
  • the axon and the nerve terminal innervating a muscle fiber degenerates.
  • Healthy denervated tissue responds by releasing cytokines that induce the terminal Schwann cells on the denervated muscle fiber to grow processes that reach the nerve terminal of a neighboring innervated muscle fiber.
  • the Schwann cell process induce a nerve sprout in the normal nerve te ⁇ ninal that grows along the Schwann cell process towards the denervated endplate until reinnervation of the denervated endplate is completed.
  • cytokine signaling language stimulated by EMF's activated PBMCs could trigger these events in neighboring healthy axons not affected by the disease producing reinervation of the denervated muscle fibers.
  • Patient 42 is a 4 year old boy with Spinal Muscular Atrophy. Being the second boy of a normal twin pregnancy and delivery, their parents had the benefit to compare one twin to the other. Their recollection suggests that early development was delayed. He started walking at 15 months but his gait appeared abnormal and since age 2 he has been unable to run or hop, has difficulty walking up one or two steps, tends to fall frequently and needs help getting back on his feet. At physical examination weakness of all muscle groups was noticeable but more so in the shoulder and pelvic girdles. These findings together with the subtle fasciculations of the tongue, electromyography, magnetic resonance imaging and left quadriceps biopsy support the diagnosis of Spinal Muscular Atrophy. During the last year, diets, rehabilitation therapy and the use of stabilizing artroses have been ineffective in improving his condition.
  • electromagnetic stimulation was then applied TO one of his arms, 2 hours/day, 2 days/week for one month, however this was difficult to achieve because of his age. Therefore a new design with Helmholtz coils was used to expose part of the body while the child was sleeping. This modality of electromagnetic stimulation was applied 2 hours/day, 5 days/week for a period of two years.
  • EMFs external, non-invasive electromagnetic fields
  • the treatment offers a remarkably effective clinical means for improving a patient's health and well being without producing adverse or negative side effects.
  • This has been exemplified on patients with various diseases and conditions, such as a history of partial denervation, internal or external lesions such as wounds, areas with inadequate blood perfusion such as viable but unde ⁇ erfused myocardium and the like, burns and ulcers alone or where the patient is suffering from other disorders as well.

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  • Magnetic Treatment Devices (AREA)

Abstract

La présente invention concerne un procédé permettant de traiter des lésions corporelles liées à une perfusion sanguine inadaptée, une dénervation partielle, une perte tissulaire, la douleur, un oedème, une inflammation et/ou infection, comprenant l'application externe ou non pénétrante sur un sujet touché par une lésion, dans une zone où la lésion a été éliminée, de champs électromagnétiques efficaces (EMF) analgésiques, angiogènes, vasculogènes, de croissance nerveuse, ostéogènes, anti- oedèmes, anti-inflammatoires et/ou cicatrisants. Lesdits champs électromagnétiques efficaces comprennent des fréquences allant de quelques Hertz à moins d'environ 300 Hz et des composantes de champ magnétique statique allant de quelques micro Tesla à une intensité maximale de environ 0,3 à environ 0,8 mT, les dits champs étant utilisés seuls ou en combinaison avec un champ magnétique statique homogène d'environ 40 à environ 80 mT ou d'environ 400 à environ 800 gauss.
PCT/IB2000/001480 1999-08-27 2000-08-22 Procede electromagnetique permettant de traiter des lesions liees a une perfusion sanguine inadaptee, une denervation partielle, une perte tissulaire, la douleur, un oedeme, une inflammation et infection WO2001015770A2 (fr)

Priority Applications (2)

Application Number Priority Date Filing Date Title
AU76793/00A AU7679300A (en) 1999-08-27 2000-08-22 Electromagnetic method of treatment of lesions associated with inadequate blood perfusion, partial denervation, tissue loss, pain, edema, inflammation and infection
CA002389134A CA2389134C (fr) 1999-08-27 2000-08-22 Procede electromagnetique permettant de traiter des lesions liees a une perfusion sanguine inadaptee, une denervation partielle, une perte tissulaire, la douleur, un oedeme, une inflammation et infection

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US15118599P 1999-08-27 1999-08-27
US60/151,185 1999-08-27

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WO2001015770A2 true WO2001015770A2 (fr) 2001-03-08
WO2001015770A3 WO2001015770A3 (fr) 2001-09-27

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AU (1) AU7679300A (fr)
CA (1) CA2389134C (fr)
TW (1) TW567078B (fr)
WO (1) WO2001015770A2 (fr)

Cited By (12)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP1366781A1 (fr) * 2002-05-29 2003-12-03 Richard Dr. Markoll Appareil pour traiter une partie du corps humain avec un champ électromagnétique
GR1004411B (el) * 2002-07-25 2004-01-07 Ηλεκτρονικηασυσκευηαγιααενισχυσηαανοσοποιητικουασυστηματοσαμεαχρησηαμαγνητικωναπεδιωναμεαχαρακτηριστικαααποαπολυδιαυλοαβιομαγνητομετρο
US6733435B2 (en) 2002-03-08 2004-05-11 Canedo Luis Electromagnetic method of treatment of lesions associated with inadequate blood perfusion, partial denervation, tissue loss, pain, edema, inflammation and infection
EP1559445A1 (fr) * 2002-03-27 2005-08-03 Nippon Sigmax Co., Ltd. Dispositif de regulation de cytokines, dispositif de traitement et procede de traitement
WO2007044386A3 (fr) * 2005-10-05 2008-01-17 Electromagnetic Resources Inc Champs electromagnetiques pour effet systemique dans une therapie
WO2011078644A2 (fr) * 2009-12-21 2011-06-30 Alandra Medical S.A.P.I. De C.V. Équipement de stimulation électromagnétique pour le traitement systémique au niveau du thorax de lésions chroniques, l'activation de l'angiogenèse et l'augmentation de la perméabilité vasculaire
WO2011078645A2 (fr) * 2009-12-21 2011-06-30 Alandra Medical S.A.P.I. De C.V. Équipement de stimulation électromagnétique pour le traitement systémique sur le bras de plaies chroniques, l'activation de l'angiogenèse et l'augmentation de la perméabilité vasculaire
CN108025180A (zh) * 2015-08-12 2018-05-11 英诺威讯有限公司 用于括约肌和其它组织再生的系统
US10076384B2 (en) 2013-03-08 2018-09-18 Symple Surgical, Inc. Balloon catheter apparatus with microwave emitter
WO2018172863A1 (fr) * 2017-02-07 2018-09-27 Santi Tofani Appareil de traitement de cellules pathologiques
US10967194B2 (en) 2018-05-02 2021-04-06 Shealy-Sorin Wellness, Llc Pulsed electromagnetic field device and methods of use
EP3744392A4 (fr) * 2018-01-24 2021-09-22 Hefei Institutes of Physical Science, Chinese Academy of Sciences Procédé de régénération de cartilage, dispositif à impulsions magnétiques et bobine appliquée à un dispositif à impulsions magnétiques

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US5441495A (en) * 1989-08-17 1995-08-15 Life Resonances, Inc. Electromagnetic treatment therapy for stroke victim
US5453073A (en) * 1990-05-04 1995-09-26 Bio Magnetic Therapy Sys Inc Apparatus for treatment of diseased body organs with magnetic field therapy
US5752911A (en) * 1995-04-27 1998-05-19 Canedo; Luis E. Electromagnetic method of treatment of epilepsy and apparatus

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US5441495A (en) * 1989-08-17 1995-08-15 Life Resonances, Inc. Electromagnetic treatment therapy for stroke victim
US5453073A (en) * 1990-05-04 1995-09-26 Bio Magnetic Therapy Sys Inc Apparatus for treatment of diseased body organs with magnetic field therapy
US5314401A (en) * 1991-03-29 1994-05-24 Amei Technologies Inc. Conformable PEMF transducer
US5752911A (en) * 1995-04-27 1998-05-19 Canedo; Luis E. Electromagnetic method of treatment of epilepsy and apparatus

Cited By (19)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6733435B2 (en) 2002-03-08 2004-05-11 Canedo Luis Electromagnetic method of treatment of lesions associated with inadequate blood perfusion, partial denervation, tissue loss, pain, edema, inflammation and infection
EP1559445A4 (fr) * 2002-03-27 2010-01-06 Nippon Sigmax Co Ltd Dispositif de regulation de cytokines, dispositif de traitement et procede de traitement
EP1559445A1 (fr) * 2002-03-27 2005-08-03 Nippon Sigmax Co., Ltd. Dispositif de regulation de cytokines, dispositif de traitement et procede de traitement
WO2003099378A1 (fr) * 2002-05-29 2003-12-04 Richard Markoll Appareil pour traiter une partie du corps au moyen d'un champ electromagnetique
EP1366781A1 (fr) * 2002-05-29 2003-12-03 Richard Dr. Markoll Appareil pour traiter une partie du corps humain avec un champ électromagnétique
WO2004011093A1 (fr) * 2002-07-25 2004-02-05 Nicolia Anninou Dispositif electronique pour renforcer le systeme immunitaire
US7258659B2 (en) 2002-07-25 2007-08-21 Nicolia Anninou Electronic device for strengthening the immune system
GR1004411B (el) * 2002-07-25 2004-01-07 Ηλεκτρονικηασυσκευηαγιααενισχυσηαανοσοποιητικουασυστηματοσαμεαχρησηαμαγνητικωναπεδιωναμεαχαρακτηριστικαααποαπολυδιαυλοαβιομαγνητομετρο
WO2007044386A3 (fr) * 2005-10-05 2008-01-17 Electromagnetic Resources Inc Champs electromagnetiques pour effet systemique dans une therapie
WO2011078644A2 (fr) * 2009-12-21 2011-06-30 Alandra Medical S.A.P.I. De C.V. Équipement de stimulation électromagnétique pour le traitement systémique au niveau du thorax de lésions chroniques, l'activation de l'angiogenèse et l'augmentation de la perméabilité vasculaire
WO2011078645A3 (fr) * 2009-12-21 2011-11-24 Alandra Medical S.A.P.I. De C.V. Équipement de stimulation électromagnétique pour le traitement systémique sur le bras de plaies chroniques, l'activation de l'angiogenèse et l'augmentation de la perméabilité vasculaire
WO2011078645A2 (fr) * 2009-12-21 2011-06-30 Alandra Medical S.A.P.I. De C.V. Équipement de stimulation électromagnétique pour le traitement systémique sur le bras de plaies chroniques, l'activation de l'angiogenèse et l'augmentation de la perméabilité vasculaire
WO2011078644A3 (fr) * 2009-12-21 2011-11-24 Alandra Medical S.A.P.I. De C.V. Équipement de stimulation électromagnétique pour le traitement systémique au niveau du thorax de lésions chroniques, l'activation de l'angiogenèse et l'augmentation de la perméabilité vasculaire
US10076384B2 (en) 2013-03-08 2018-09-18 Symple Surgical, Inc. Balloon catheter apparatus with microwave emitter
CN108025180A (zh) * 2015-08-12 2018-05-11 英诺威讯有限公司 用于括约肌和其它组织再生的系统
US11364390B2 (en) 2017-02-07 2022-06-21 Santi Tofani Apparatus for treating pathological cells
WO2018172863A1 (fr) * 2017-02-07 2018-09-27 Santi Tofani Appareil de traitement de cellules pathologiques
EP3744392A4 (fr) * 2018-01-24 2021-09-22 Hefei Institutes of Physical Science, Chinese Academy of Sciences Procédé de régénération de cartilage, dispositif à impulsions magnétiques et bobine appliquée à un dispositif à impulsions magnétiques
US10967194B2 (en) 2018-05-02 2021-04-06 Shealy-Sorin Wellness, Llc Pulsed electromagnetic field device and methods of use

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CA2389134C (fr) 2006-05-16
CA2389134A1 (fr) 2001-03-08
WO2001015770A3 (fr) 2001-09-27
AU7679300A (en) 2001-03-26
TW567078B (en) 2003-12-21

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