1. Field of the Invention
The present application relates to a method of medical treatment, and more particularly to a method for treating people with vascular health problems by the application of neuromuscular stimulation leading to the generation of endothelial mechanotransduction, which boosts endocrine, autocrine and paracrine activity resulting in an increase in vasoactive substances.
2. Description of Related Art
Blood vessels traverse all throughout our bodies. The endothelium is the inner lining of all blood vessels. It is the largest organ in the body. If flattened and spread out, it is equivalent in size to approximately six tennis courts. Once thought to be inert and unimportant, research has shown it to be an extremely important organ that exerts control over an array of mechanisms which serve to maintain vascular tone and blood fluidity by:                Maintaining vascular smooth muscle tone        Regulating angiogenesis and cell proliferation        Mediating inflammatory and immune responses        Regulating vascular permeability        Regulating thrombolysis        Regulating leukocyte adhesion        Regulating platelet adhesion and aggregation        Regulating lipid oxidation        
The endothelium exerts this control through endocrine, paracrine and autocrine processes wherein the endothelial cells secrete vasoactive substances such as hormones, genes, proteins, transcription factors and others, resulting in the regulatory actions listed above. This group of events is generally known as, “endothelial mechanotransduction.” Mechanotransduction refers to the processes through which cells sense and respond to mechanical stimuli by converting them to biochemical signals that elicit specific cellular responses. While shear stress and mechanotransduction are well documented in the literature, no one has proposed the use of endothelial mechanotransduction as a therapy.
Endothelial mechanotransduction happens in response to blood flow and laminar shear stress, induced from the mechanical forces caused by the rubbing of blood cells on the endothelium (the lining of blood vessels). When people are young, the normal physiologic levels of blood flow and shear stress keep blood vessels (and the whole cardiovascular system) healthy. Later in life, people make diet and lifestyle choices that can lower blood flow, clog the blood vessels with fatty deposits and impair the regulatory processes necessary for vascular health. The endothelium can then become dysfunctional contributing to atherosclerosis (hardening of the arteries), diabetes, hypertension (high blood pressure), delayed wound healing, vasculitis, congestive heart failure, critical limb ischemia, neuropathy and more.
Endothelial dysfunction is a major health problem in the U.S. with more than 65,000 peer-reviewed articles on this topic. Various different methods have been used, experimentally, to treat endothelia dysfunction. Methods involve the use of drugs, or external compression devices.
There are drugs labeled “NO donors” which cause the body to generate NO and several are in current tests to determine their efficacy and safety. Aside from nitroglycerin, few have made it into the marketplace and the only one in widespread use is for erectile dysfunction. Erectile dysfunction, like endothelial dysfunction, is caused by a lack of NO. These drugs can have many disadvantages and undesirable side effects when used.
Although electrical stimulation for medical purposes has been in use for more than a hundred years, its use has largely been defined by the effects of various types of current (i.e., galvanic, interferential, “Russian”, faradic, high voltage pulsed current, micro-current, etc.). In current practice, electrical stimulation is primarily used by physicians, physical therapists, chiropractors, athletic trainers and rehabilitation facilities for the following purposes: sore and torn muscles and tendons, bone fractures, healing of decubitus and diabetic ulcers, pain alleviation, relief from muscle spasms and treatment for disuse atrophy. The localized, minor movement of blood is often mentioned as part of the treatment. Functional electrical stimulation (FES) is primarily used to retrain muscles in patients with spinal cord or neuronal injury.
There are also electrical stimulators in use for narrowly defined special uses, including: implanted spinal stimulation for pain alleviation, implanted stimulation of the vagus nerve for epilepsy, U.S. Pat. No. 5,928,272, Adkins, et al (1999) and FES units for pharyngeal muscle re-education for the act of swallowing, U.S. Pat. No. 6,104,958, Freed et al (2000).
Several devices on the market produce electrical stimulation waveforms adequate to contract skeletal muscle (i.e. Rich-Mar Corp's Theratouch 4.7, Pro-Med's model 7560, Microvas Technologies' models I and II, NeuroCare's NC1000), all of these devices, however, apply stimulation to several treatment locations simultaneously, which can create back pressure thus reducing the pumping action of the one-way valves in the venous system. Furthermore, all of these devices have an inadequate number of leads to treat the large areas or to generate the volume and velocity needed to reach therapeutic levels of mechanotransduction.
Several devices have attempted to achieve upregulated blood flow through means of externally applied hydraulic pressure as shown in U.S. Pat. No. 6,863,670 to Zheng (2005), or pneumatic pressure as in U.S. Pat. No. 6,358,219 to Arkans (2002). In these applications, the invention squeezes the leg by way of inflatable cuffs around the leg. The veins, in the muscles, are also squeezed, although much of the pressure is absorbed by the relaxed muscle mass which acts as a cushion to dissipate the pressure. A problem common to external compression is chaffing and bruising from the extreme pressures and repetitive squeezing of the cuffs.
While these inventions do manage to accomplish some movement of blood, their method is limited in effectiveness because they are squeezing through thick layers of relaxed muscles, forming a cushion and the squeezing forces are therein blunted. It is desired that pressure be applied directly to the veins in a manner similar to that seen with typical body movements.
One novel form of stimulation for blood flow is U.S. Pat. No. 5,195,518 to Mannion, et al (1993) which involves the surgical attachment of skeletal muscles to the heart, then applying stimulation to the attached muscle in an attempt to drive blood to an ischemic heart. The extreme costs and invasive nature of this invention would tend to limit its application.
Although some small strides have been made to treat endothelial dysfunction, considerable shortcomings remain. A therapy for the creation of endothelial mechanotransduction and thereby restores vascular homeostasis is needed.