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 PDFInfo
- 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
- Authority
- WO
- WIPO (PCT)
- Prior art keywords
- electrode
- wound
- healing
- current
- electrodes
- Prior art date
Links
- 238000000034 method Methods 0.000 title claims abstract description 19
- 230000035876 healing Effects 0.000 title claims description 20
- 206010052428 Wound Diseases 0.000 title abstract description 46
- 208000027418 Wounds and injury Diseases 0.000 title abstract description 46
- 230000000638 stimulation Effects 0.000 title abstract description 9
- 238000011282 treatment Methods 0.000 claims description 11
- 230000037380 skin damage Effects 0.000 claims description 2
- 230000002708 enhancing effect Effects 0.000 claims 1
- 208000025865 Ulcer Diseases 0.000 description 26
- 231100000397 ulcer Toxicity 0.000 description 23
- 210000003491 skin Anatomy 0.000 description 20
- 230000001684 chronic effect Effects 0.000 description 10
- 210000001519 tissue Anatomy 0.000 description 9
- 208000004210 Pressure Ulcer Diseases 0.000 description 8
- 238000002266 amputation Methods 0.000 description 8
- 238000002560 therapeutic procedure Methods 0.000 description 6
- 208000000558 Varicose Ulcer Diseases 0.000 description 5
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 description 5
- 238000012377 drug delivery Methods 0.000 description 5
- 201000002282 venous insufficiency Diseases 0.000 description 5
- 206010030113 Oedema Diseases 0.000 description 4
- 201000002816 chronic venous insufficiency Diseases 0.000 description 4
- 206010012601 diabetes mellitus Diseases 0.000 description 4
- 230000004087 circulation Effects 0.000 description 3
- 201000010099 disease Diseases 0.000 description 3
- 210000003414 extremity Anatomy 0.000 description 3
- 210000002414 leg Anatomy 0.000 description 3
- 230000010287 polarization Effects 0.000 description 3
- 230000002035 prolonged effect Effects 0.000 description 3
- 230000036269 ulceration Effects 0.000 description 3
- 230000029663 wound healing Effects 0.000 description 3
- 206010060708 Induration Diseases 0.000 description 2
- 208000005230 Leg Ulcer Diseases 0.000 description 2
- 206010031252 Osteomyelitis Diseases 0.000 description 2
- KDLHZDBZIXYQEI-UHFFFAOYSA-N Palladium Chemical compound [Pd] KDLHZDBZIXYQEI-UHFFFAOYSA-N 0.000 description 2
- 206010037549 Purpura Diseases 0.000 description 2
- 208000028990 Skin injury Diseases 0.000 description 2
- 208000002847 Surgical Wound Diseases 0.000 description 2
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- 210000000988 bone and bone Anatomy 0.000 description 2
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- 210000003141 lower extremity Anatomy 0.000 description 2
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- BASFCYQUMIYNBI-UHFFFAOYSA-N platinum Chemical compound [Pt] BASFCYQUMIYNBI-UHFFFAOYSA-N 0.000 description 2
- 229920001296 polysiloxane Polymers 0.000 description 2
- 230000008569 process Effects 0.000 description 2
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- 239000008223 sterile water Substances 0.000 description 2
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- IJJWOSAXNHWBPR-HUBLWGQQSA-N 5-[(3as,4s,6ar)-2-oxo-1,3,3a,4,6,6a-hexahydrothieno[3,4-d]imidazol-4-yl]-n-(6-hydrazinyl-6-oxohexyl)pentanamide Chemical compound N1C(=O)N[C@@H]2[C@H](CCCCC(=O)NCCCCCC(=O)NN)SC[C@@H]21 IJJWOSAXNHWBPR-HUBLWGQQSA-N 0.000 description 1
- 241000197194 Bulla Species 0.000 description 1
- OKTJSMMVPCPJKN-UHFFFAOYSA-N Carbon Chemical compound [C] OKTJSMMVPCPJKN-UHFFFAOYSA-N 0.000 description 1
- 206010007882 Cellulitis Diseases 0.000 description 1
- 208000034656 Contusions Diseases 0.000 description 1
- 201000004624 Dermatitis Diseases 0.000 description 1
- 206010056340 Diabetic ulcer Diseases 0.000 description 1
- 206010063560 Excessive granulation tissue Diseases 0.000 description 1
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- 208000004221 Multiple Trauma Diseases 0.000 description 1
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- 208000014674 injury Diseases 0.000 description 1
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- 210000003127 knee Anatomy 0.000 description 1
- 230000003902 lesion Effects 0.000 description 1
- 238000012423 maintenance Methods 0.000 description 1
- VNWKTOKETHGBQD-UHFFFAOYSA-N methane Chemical compound C VNWKTOKETHGBQD-UHFFFAOYSA-N 0.000 description 1
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- 230000000474 nursing effect Effects 0.000 description 1
- 229910052760 oxygen Inorganic materials 0.000 description 1
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- 238000007920 subcutaneous administration Methods 0.000 description 1
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- 230000000451 tissue damage Effects 0.000 description 1
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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.
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 |
Family
ID=23972750
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)
| Country | Link |
|---|---|
| AU (1) | AU6481496A (fr) |
| WO (1) | WO1997001372A1 (fr) |
Cited By (4)
| 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 |
| WO2007106270A3 (fr) * | 2006-02-13 | 2008-03-20 | 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)
| 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 |
-
1996
- 1996-06-28 AU AU64814/96A patent/AU6481496A/en not_active Abandoned
- 1996-06-28 WO PCT/US1996/011093 patent/WO1997001372A1/fr active Application Filing
Patent Citations (1)
| 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 (4)
| 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 |
| 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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