WO1997001372A1 - Appareil et procede de cicatrisation de blessures faisant appel a une stimulation electrique - Google Patents

Appareil et procede de cicatrisation de blessures faisant appel a une stimulation electrique Download PDF

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Publication number
WO1997001372A1
WO1997001372A1 PCT/US1996/011093 US9611093W WO9701372A1 WO 1997001372 A1 WO1997001372 A1 WO 1997001372A1 US 9611093 W US9611093 W US 9611093W WO 9701372 A1 WO9701372 A1 WO 9701372A1
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WO
WIPO (PCT)
Prior art keywords
electrode
wound
healing
current
electrodes
Prior art date
Application number
PCT/US1996/011093
Other languages
English (en)
Inventor
Dean L. Kellogg, Jr.
Original Assignee
Board Of Regents, The University Of Texas System
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Board Of Regents, The University Of Texas System filed Critical Board Of Regents, The University Of Texas System
Priority to AU64814/96A priority Critical patent/AU6481496A/en
Publication of WO1997001372A1 publication Critical patent/WO1997001372A1/fr

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/326—Applying electric currents by contact electrodes alternating or intermittent currents for promoting growth of cells, e.g. bone cells

Definitions

  • the present invention relates generally to a method and apparatus for treating soft tissue wounds. More particularly, it relates to a method and apparatus for accelerating the healing of chronic wounds by electrical stimulation.
  • Prior attempts at applying electrical treatments to the human body generally used direct current. This was found to be accompanied by a number of undesirable side effects, such as the occurrence of skin injury in the form of iontophoretic burns and irritation in the treated area, as well as the formation of undesirable vesicles or bulla, on the skin and in the treated area.
  • Various complicated or compromised methods for preventing these iontophoretic burns have been developed. However, such methods and apparatus have generally been found not to be adequately effective for preventing irritation in the formation of vesicles or bulla on the skin and treated area. Consequently, iontophoretic treatments have usually been limited to relatively low electrical currents and relatively short periods of administration of, typically, twenty minutes or less.
  • the unique AC current system of the LectroPatchTM iontophoresis system is an important safety feature that allows direct application of the device to heal wounds.
  • Standard iontophoresis systems employ continuous direct current which makes them unsuitable for wound healing applications because of two significant limiting factors.
  • DC iontophoresis is thought to cause polarization in the skin orientating the skin in a direction opposite that of the applied field. The skin then acts like a capacitor decreasing the effective current passing through the skin as the duration of DC current continues. In an effort to avoid this polarization pulsed DC iontophoresis has been used with limited success.
  • McWhorter, et al. U.S. Patent No. 5,158,081. It has been found that the slow AC cycle of the LectroPatchTM system overcomes this problem of skin polarization.
  • ulcers Chronic, non-healing cutaneous ulcers (hereinafter referred to as "ulcers") are a major unresolved health problem.
  • cutaneous ulcers appear on an extremity, and are often indicative of a secondary disorder, i.e. a peripheral circulatory disorder.
  • Cutaneous ulcers which are secondary to a peripheral circulatory disorder are generally classified as venous stasis ulcers, diabetic ulcers, or decubitus ulcers. Although most ulcers are secondary to a peripheral vascular disease, some are secondary to dermatological, endocrine, hematological, or other systemic diseases.
  • Venous stasis ulcers are caused by chronic venous insufficiency.
  • Chronic venous insufficiency is a pathological condition of the skin and subcutaneous tissues of the lower extremity that results from prolonged stasis of the venous blood flow.
  • Venous stasis is primarily caused by an abnormal venous hypertension that exists with post phlebitic conditions or with incompetent varicose veins.
  • the elevated venous pressure disrupts the delicate balance between the intravascular and interstitial forces of the capillary bed. Fluid leaves the intravascular compartment and enters the surrounding interstitial tissue. Edema and stasis develop as a result in most instances.
  • the first observable manifestation of chronic venous insufficiency is usually edema.
  • Ulceration is a common disabling complication of chronic venous insufficiency. In many instances, the ulcers develop at the site of minor contusions. In other instances, they develop at areas of dermatitis or chronic induration. Sometimes they follow minor infections in the skin. The ulcers occasionally heal readily, but more often they are chronic, refractory to therapy, and are classified as "non-healing.”
  • Venous stasis ulcers are treated with bed rest and elevation of the legs above the heart level. Pressure is applied to the area of the ulcer, typically by support stockings, to alleviate non-healing in the extremity. Antibiotics are occasionally indicated, especially when the ulcer is surrounded by severe, acute cellulitis. If the ulcer fails to heal spontaneously with these measures, skin grafting may be required. In 1979, there were about 128,000 patients hospitalized primarily for non-healing venous stasis ulcers with an average 11.4 day length of stay, which, at $200 per day, amounted to about $300 million in health care costs.
  • decubitus ulcers In contrast to venous stasis ulcers, where there is blood pooling, decubitus ulcers are caused by the ischemic necrosis and ulceration of tissues overlying a bony prominence wliich has been subject to prolonged pressure. Generally, this pressure is caused by a bed, wheelchair, cast, or splint. Decubitus ulcers are most frequently seen in patients who are debilitated, paralyzed, or otherwise long bedridden. Depending on the patient's position various areas on the patient's body may be affected. However, the feet and sacral areas are most often afflicted. Decubitus ulcers can affect not only superficial tissues, but also muscle and bone. The most important single precipitating factor for decubitus ulcers is pressure.
  • decubitus ulcers are treated by alleviating the pressure on the afflicted area, and if possible, by lowering the extremity below the heart level to increase circulation to the area. Decubitus ulcers occasionally heal spontaneously; however, decubitus ulcers are more often refractory to therapy and require surgical intervention.
  • Diabetics have an abnormality of the capillary basal lamina (basement membrane) characterized by thickening of the lamina of capillary beds of the skin and skeletal muscle. The process affects, among other areas, the legs and feet.
  • Microvascular disease typically in combination with neuropathy, causes the associated skin and underlying tissue to become anoxic. If the tissue remains anoxic for a sufficient time, the tissue becomes necrotic and cutaneous ulcerations form. Generally, these ulcers occur on the feet or lower extremities. The goal of treatment is often returning circulation to the necrotic area. However, because these ulcers are often refractory to treatment, surgical intervention is frequently required.
  • ulcers are characterized as non- healing if they are refractory to therapy and are present for greater than a year, or are progressing towards healing at a rate of less than or equal to 1 millimeter per week.
  • the present invention provides an apparatus and method for treating wounds by electrical stimulation while mi iimizing skin injury.
  • the apparatus consists of two electrodes one of which is placed inside of the wound and an AC power source connected to the electrodes delivering about 0.075 to 0.150 mA/cm 2 at a frequency between about 0.0027 and 10 Hz.
  • the two electrodes are separable which allows large and deep wounds to be treated and avoids electrical short circuits which may occur in treating large wounds. No drug delivery is involved; only AC electrical current is needed to promote the healing of the wounds.
  • wound healing is enhanced by placing an electrode inside the wound, placing another electrode near the first electrode either inside or outside the wound, and applying AC current to the electrodes at a frequency approximately between 0.0027 and 10 Hz and a current density approximately between 0.075 and 0J50 mA/cm 2 .
  • the electrodes should be placed least 0J inches, but not more than 2 inches apart from one another.
  • the healing of a wound on a biological subject may be accelerated by conducting an electric current through a surface of the wound in a first direction from a first electrode to a second electrode on the subject. And intermittently reversing, at a relatively low frequency which prevents skin damage, between approximately 20 times per second and approximately once every three minutes, the polarity of the electrodes to cause electrical current to flow in a second direction opposite to the first direction, whereby such electric treatment of the wound may be continuous for extended periods of time.
  • FIG. 1 is a schematic view of a wound being treated with an electrical stimulation device in accordance with the present invention.
  • a wound 10 is being treated by placing a first electrode 20 into the wound, placing another electrode 30 proximate to and apart from the first electrode 20, and applying to the electrodes alternating current from an AC power source 40.
  • the second electrode 30 is placed proximate to the first electrode 20 such that the electric current passes through and/or around the wound 10, but not so close to the first electrode as to cause a short circuit. It has been found that a space of approximately 1/4" between the two electrodes is sufficient for most applications.
  • the second electrode 30 may be placed inside the wound opposite the first electrode 20. In smaller wounds, it may be necessary to place the second electrode 30 outside and near the periphery of the wound 10.
  • the AC power source delivers a current density about 0.075 to 0.150 mA/cm 2 at a frequency about 0.0027 to 10 Hz. It should be noted that no drug delivery is needed; only AC electrical current is necessary to promote the healing of the wound 10 in accordance with the present invention.
  • the first and second electrodes, 20 and 30, may be constructed from any electrically conductive material which is biologically inert such as silicone/carbon, platinum, rhodium, or palladium. The relatively less expensive silicone/carbon electrodes are preferred.
  • Electrode size may vary according to wound size, e.g. may be larger for larger wounds.
  • Example 1 On October 21, 1993 a diabetic patient having a chronic ulcer with osteomyelitis was treated with an embodiment of the present invention.
  • the ulcer has failed to respond to all known therapies including hyperbaric oxygen.
  • the patient was advised by surgeons that he needed at least a partial foot amputation for the ulcer.
  • Two LectroPatchTM drug delivery systems were used, each being slightly altered.
  • the LectroPatchTM devices were altered such each device functioned as a separate electrode with the two devices being wired together to form an electrode pair between which alternating current could be passed. This allowed the electrodes to be spatially separated.
  • the devices were not loaded with any drug; instead they were was filled with sterile water.
  • One device was placed inside the chronic wound and the other was placed in contact with the skin outside the wound. The device was operated at a frequency of 0.0167 Hz and a current density of 0J50 mA/cm 2 .
  • the chronic ulcer began healing within a few weeks and healed completely after seven months of daily 30 minute treatments. No drug delivery was involved only AC electrical current was used.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Cell Biology (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Radiology & Medical Imaging (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Electrotherapy Devices (AREA)

Abstract

Cette invention concerne un appareil (40) ainsi qu'un procédé de traitement de blessures faisant appel à une stimulation électrique en CA. Ce procédé consiste à placer une électrode (20, 30) directement dans la blessure, à placer l'autre électrode dans la blessure, ou hors de celle-ci, à proximité immédiate de la première électrode, et à appliquer un courant alternatif à ces électrodes qui permette d'obtenir une densité de courant variant environ entre 0,075 mA/cm2 et 0,150 mA/cm2, à une fréquence variant environ entre 0,0027 Hz et 10 Hz.
PCT/US1996/011093 1995-06-29 1996-06-28 Appareil et procede de cicatrisation de blessures faisant appel a une stimulation electrique WO1997001372A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
AU64814/96A AU6481496A (en) 1995-06-29 1996-06-28 Apparatus and method for healing wounds using electrical stimulation

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US49646695A 1995-06-29 1995-06-29
US08/496,466 1995-06-29

Publications (1)

Publication Number Publication Date
WO1997001372A1 true WO1997001372A1 (fr) 1997-01-16

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Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US1996/011093 WO1997001372A1 (fr) 1995-06-29 1996-06-28 Appareil et procede de cicatrisation de blessures faisant appel a une stimulation electrique

Country Status (2)

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AU (1) AU6481496A (fr)
WO (1) WO1997001372A1 (fr)

Cited By (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6941173B2 (en) 2000-06-01 2005-09-06 Lifewave Ltd. Method for the treatment of bedsores using electrical impulses
WO2007106270A2 (fr) * 2006-02-13 2007-09-20 Robert Tapper Courants galvaniques ou alternatifs lents stimulants à effets physiologiques thérapeutiques
EP2990075A1 (fr) * 2014-08-29 2016-03-02 ADB International Group Inc. Diagnostic de plaie
US9468758B2 (en) 2008-11-27 2016-10-18 E-Qure Corp. Wound diagnosis

Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5158081A (en) * 1991-05-29 1992-10-27 Trillion Medical Resources, Inc. Method for treatment of soft tissue wounds by electrical stimulation

Patent Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5158081A (en) * 1991-05-29 1992-10-27 Trillion Medical Resources, Inc. Method for treatment of soft tissue wounds by electrical stimulation

Cited By (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6941173B2 (en) 2000-06-01 2005-09-06 Lifewave Ltd. Method for the treatment of bedsores using electrical impulses
WO2007106270A2 (fr) * 2006-02-13 2007-09-20 Robert Tapper Courants galvaniques ou alternatifs lents stimulants à effets physiologiques thérapeutiques
WO2007106270A3 (fr) * 2006-02-13 2008-03-20 Robert Tapper Courants galvaniques ou alternatifs lents stimulants à effets physiologiques thérapeutiques
US9468758B2 (en) 2008-11-27 2016-10-18 E-Qure Corp. Wound diagnosis
EP2990075A1 (fr) * 2014-08-29 2016-03-02 ADB International Group Inc. Diagnostic de plaie

Also Published As

Publication number Publication date
AU6481496A (en) 1997-01-30

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