Procedure and machine for electro-inducing/stimulating...

Surgery: light – thermal – and electrical application – Light – thermal – and electrical application – Electrical therapeutic systems

Reexamination Certificate

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Reexamination Certificate

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06745078

ABSTRACT:

BACKGROUND OF THE INVENTION
This invention generally relates to therapeutic treatment of human and animal tissues and more particularly concerns a procedure and machine for electro-inducing or stimulating deep layered muscle contractions in tissues for the purpose of healing and treating wounds and various vascular deficiency ailments such as peripheral vascular disease, ischemic rest pain, diabetic neuropathy, pressure ulcers, slow or non-healing wounds, chronic low back pain, osteoarthritis, occupational problems such as carpal-tunnel syndrome, tendonitis and other sports injuries.
An underlying characteristic of the above conditions and diseases is impaired circulation in the capillary beds as well as nerve damage. Without blood flow to the tissues, oxygen and nutrients cannot get into the tissues and the waste products of metabolism cannot get out. This puts a severe stress on the tissues causing them to go into a survival mode. The cells use what limited resources they have to stay alive and higher functions, including healing and repair, as well as tissue mediated immunity, become essentially shut down. In most patients with severe disease, measured tissue oxygen levels have been found to be less than 15% of normal. Diabetics with impaired basement membrane function, Reynauds phenomena, Claudication states and other similar conditions all may have similar features due to this underlying characteristic.
Essentially, every tissue in the body has intrinsic electrical properties. Because of this, it has been found that they respond to electrical stimulation. There have been many machines designed over the years to use electricity to affect the body in various ways to enhance the healing process. There are many variables in the use of electricity, including polarity, voltage, amperage, frequency and waveform. Although there are a variety of alternate technologies available today, the electronic parameters of known machines have limited applications.
Hyperbaric oxygen therapy has been shown to be effective in healing ischemic ulcers. 100% oxygen at 2 atmospheres will give a partial pressure of oxygen 10 times normal. This greatly increases the rate of diffusion through the open face of the ulcer. Skin, however, is not as permeable to oxygen diffusion and oxygen delivery depends upon intact circulation as well. Hyperbaric oxygen therapy is a passive process and does not alter the underlying disease in the microcirculation.
There are several procedures in practice using moist heat with occlusion dressings, infrared lamps, membranes with electrical currents and warm water whirlpool treatments. These have all shown some merit and have been effective in varying degrees. They all work by stimulating the arterioles in the capillary beds to dilate in response to infrared energy. These also are passive procedures, however, and do not alter the underlying disease in the microcirculation.
Machines using high frequency interferential electrical currents are also effective. They stimulate the nerves in the skin and cause dilation of the capillary beds through the reflex pathways. However, this form of electrical current tends to be more superficial in the tissues and, therefore, less decisive and rapid in its healing effects.
Another procedure being used today consists of a garment placed around the diseased limb. Intermittent compression is then administered via compressed air from the attached machine. This again has proven to be effective to promote circulation and healing by pumping the blood through the capillary beds. Pressure gradients are increased in the capillary beds but there is not necessarily the dilation of the arterioles as the other methods promote. This procedure does not remodel the microcirculation either.
It is, therefore, an object of this invention to provide an electrical tissue treating procedure and machine which increases circulation in capillary beds. Another object of this invention is to provide an electrical tissue treating procedure and machine which significantly remodels microcirculation so as to provide more permanent therapeutic improvement. A further object of this invention is to provide an electrical tissue treating procedure and machine which not only dilates arterioles but also increases pressure gradients across the capillary beds to improve flow and oxygen levels and promote angiogenesis. Yet another object of this invention is to provide an electrical tissue treating procedure and machine which provides deep layered muscle contractions and perfuses tissues with blood so as to afford more decisive and rapid healing than known methods and machines. It is also an object of this invention to provide an electrical tissue treating procedure and machine which facilitates more rapid and decisive healing of vascular deficiency ailments than known procedures and machines.
SUMMARY OF THE INVENTION
In accordance with the invention, a procedure and machine are provided to promote healing by causing muscle fasciculation and contraction relaxation cycles that effectively pump blood through the microcirculation, draining the venous beds and raising the tissue oxygen levels. This, in turn, supplies the oxygen and substrates necessary to greatly accelerate the healing process. Pressure gradients are actually increased across the capillary beds with perfusion of blood into the designated area of the patient, in contrast to merely dilating the capillary beds. Therefore, the treatment has a potent effect on the microcirculation, which results in dramatic responses to treatment. Transcutaneous oxygen monitors have demonstrated marked increases in tissue oxygen levels within minutes of initiating treatment. Tissue oxygen levels with successive treatments continue to improve.
A high phase charged system is electronically pulsed and adjusted to induce deep-layered muscle contractions, causing greatly increased flow rates of both blood and lymphatics, patency of vessels permitting, and forcing blood into the microcirculation of the treated tissue.
The machine electrical waveform stimulates angiogenesis, that is, budding of new capillaries and generation of denser capillary networks in the tissues. This lays the groundwork for new tissue growth and repair in the healing process. The machine electrical waveform also raises the metabolic rate in the treated tissues, which, it is theorized, helps the intimal lining of the arteries to metabolize the excess unused nutrients clogging them. Whatever the actual cause, the effect is improved blood flow that has been shown to be permanent, particularly in patients with neuropathy.
The procedure and machine have been tested on diabetics with severe ischemic ulcers in feet that were destined for amputation. This condition is usually associated with underlying osteomeyelitis, which does not respond well to standard therapy including systemic antibiotics and wound care. The present treatment greatly improves the management of this condition because the enhanced blood flow brings enhanced levels of antibiotics and healing to the affected area. In almost every case, the feet have been salvaged.
In addition, the machine's electrical waveform directly stimulates the activity of fibroblasts in the healing process. In the healing of ischemic ulcers the fibroblasts act first to build the framework upon which further cell types including skin and capillaries grow. The electrical current is a deep penetrating current that affects all tissues from the skin to the bone. Technically, the machine generates an electromagnetic field between the emitter pads, in contrast to the electrical waveform of some machines that stay rather superficial in the tissues affecting primarily the top several millimeters. The system stimulates activity in bone cells as well, which accelerates fracture healing.
Finally, the procedure and machine have achieved excellent test case success in reversing neuropathy in the feet and legs of diabetics being treated. In follow up on this condition thus far, improvement has persisted for extended periods of time. There is n

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