WO2016044596A1

WO2016044596A1 - Muscle optimization device and method

Info

Publication number: WO2016044596A1
Application number: PCT/US2015/050695
Authority: WO
Inventors: Kimberly S. GANGWISH; Garret Moddel; Michael TROLIER; Charles KREBS
Original assignee: Genovus Biotechnologies Inc.
Priority date: 2014-09-18
Filing date: 2015-09-17
Publication date: 2016-03-24
Also published as: WO2015143211A1; EP3119372A1; CA2943178A1; EP3119372A4; AU2015231182A1; AU2015231182B2

Abstract

A system, device and method are provided for therapy and treatment of biological tissue such as muscle, tendon, ligament, and nerve tissue, by use of a device and method in which tissues and associated proprioceptors and neuromuscular feedback loops are exposed to therapeutic resonant frequency patterns (TRFP) or therapeutic frequency resonance patterns, and/or TRFPs are transmitted to tissues of a patient. The resonance frequencies originate from many bioactive substances or resonance domains. These resonance patterns may be passively excited and transmitted to a patient to provide therapeutic benefits for muscle tissue dysfunction. TFRPs or therapeutic frequency resonance patterns may also be actively excited by a delivery mechanism that uses electromagnetic or mechanical waves to interact with the device. The actively excited device transmits the TRFPs or therapeutic frequency resonance patterns to the patient for similar enhancements and therapeutic benefits.

Description

MUSCLE OPTIMIZATION DEVICE AND METHOD

CROSS REFERENCE TO RELATED APPLICATION

This application claims priority to PCT Application No. PCT/US2015/021554 filed March 19, 2015, and this application claims priority to U.S. Patent Application Serial No. 14/490,378 filed on September 18, 2014, which are incorporated herein in their entirety by reference.

FIELD OF THE INVENTION

The present invention relates generally to the field of muscle stimulation, and more particularly, to therapy and treatment of muscle, tendon, ligament, and nerve tissue by use of a device and method in which tissues and associated proprioceptors and neuromuscular feedback loops are exposed to therapeutic resonant frequency patterns (TRFPs) or therapeutic frequency resonance patterns, and/or the TRFPs are transmitted to a patient.

BACKGROUND OF THE INVENTION

Stimulation and exercise of muscle tissue is necessary for the rehabilitation and continued development of damaged and/or poorly functioning muscle tissue. The failure to stimulate and exercise muscle tissue inevitably results in muscle atrophy, and long periods of muscle inactivity can result in permanent damage.

There are a number of existing devices and methods that are used for muscle stimulation and rehabilitation, primarily in the field of neuromuscular electrical stimulation (NMES). NMES is known to provide many therapeutic benefits such as prevention or retardation of disuse atrophy, pain relief, improvement of blood circulation, and others. Most forms of electrical stimulation involve the delivery of intermittent and repeating series of electrical pulses to the targeted muscle tissue(s). In many systems, the pulses are delivered transcutaneously by surface electrodes that are placed on the patient's skin over the targeted muscle area(s).

Included within this body of knowledge regarding NMES are a number of patent references. One example includes the US Patent No. 8,265,763. This reference discloses systems and methods for neuromuscular electrical stimulation. Stimulation electrodes are provided on a stimulation pad, configured to provide electrical stimulation to a targeted tissue. A system for neuromuscular electrical stimulation also includes a pressure generating mechanism to provide a compressive force to a region of the targeted tissue, thereby removing excess fluid from the region.

Another example of a US patent reference includes the US Patent No. 8,315,71 1. This reference discloses a method and apparatus using resonant pulses to treat diabetes, carpal tunnel syndrome, arthritis, and other maladies by applying a stimulating signal to promote and manipulate blood flow. The stimulating signal may include a resonant sequence that includes at least three pulses, where the pulses of the resonant sequence are spaced relative to one another such that each pulse subsequent to a first pulse in the sequence is effective to progressively stimulate and create tension in a musculature that includes the muscle inwardly from the electrodes and towards the center of the musculature, while maintaining the tension created in at least a portion of the musculature by each preceding pulse in the resonant sequence.

Yet another example of a US patent reference that discloses an invention in this field is the US Patent 8, 145,318. This reference generally discloses an apparatus for electrical stimulation of muscle tissue, including an electrode system with an electrode array. The array has a plurality of electrode pads and is placed in electrical contact with the targeted muscle tissue. The electrode system further includes a sensor for sensing a property of the muscle tissue. This property forms a measure for the activity of the muscle tissue. The apparatus includes an electrode selector for selecting one or more stimulating electrode pads. A signal generator is connected to the electrode array for providing an electrical stimulation signal to the stimulation electrode pad. A signal processor is connected to the sensor for determining from the sensor signal a value of the muscle activity, and outputting the value to a human perceptible form. This reduces the accuracy required to position the electrode system and increases the accuracy of measuring muscle tissue activity.

Another example of a US patent reference includes the US Patent No. 7, 175,587. This reference discloses an apparatus and method for using pulsed electromagnetic field (PEMF) to provide a therapeutic benefit. This reference describes inducing a magnetic field in a biological system where the pulsed electromagnetic field is used for therapeutic treatment of injury, illness, and/or aging. A straight wire element generates an electromagnetic field in response to a current pulse through the straight wire element, and a circuit that supplies the current pulse does so using a square pulse. This allows the PEMF device to generate an electromagnetic field with rapid rise and fall times and to provide the desired therapeutic benefit.

As further background, it is helpful to understand basic muscle physiology. Muscle fibers are activated when an alpha motor neuron (which extends from the spinal cord to the muscle) is activated. Each alpha motor neuron activates a unique set of individual muscle fibers in what is called a "motor unit." The amount of force that a muscle can generate is directly related to the number of motor units that are activated. During muscle testing, if the subject can resist the amount of pressure applied, then the muscle has been activated isometrically and no change in joint position is noted. However, if the muscle cannot resist the amount of force applied, the muscle will lengthen in what is called an eccentric contraction and there is a change in joint position or angle.

Whether or not a subject can resist the pressure applied during muscle testing depends on many factors, both excitatory and inhibitory. In other words, the level of activation of the alpha motor neuron depends on complex interactions between neurons in the spinal cord. One of the major factors that influences alpha motor neuron activity is the effect of feedback from the muscle spindle and the Golgi Tendon Organ (GTO). The muscle spindle and GTO are sensory organs located within the muscle and tendon, respectively, and provide rich information about the length of the muscle and the amount of force produced by the muscle. For example, when a muscle is stretched, all the muscle fibers are lengthened, including the muscle spindles. The muscle spindle signals the change in the length of the muscle and activates the 1 a sensory nerve that

communicates the change to the spinal cord. The activation of the 1 a nerve can cause activation of the alpha motor neuron of the same muscle (the agonist), and inhibit the activation of the opposite muscle (the antagonist). The GTO registers the amount of muscle force, but may also inhibit force production if there is a possibility of muscle damage at high forces. Inputs on the alpha motor neurons can also come from supraspinal areas of the cerebral cortex, cerebellum, or brainstem or reflexes.

Together these sensors that sense position, length, and tension of muscles are called "proprioceptors". The feedback from these sensors, which are actually specialized nerve endings, goes entirely to the spinal column and subconscious parts of the brain, e.g. spinal segments, brainstem, basal ganglia, thalamus, cerebellum, etc. This provides the body with information on the state of muscle contraction, muscle and tendon tension, position and activity of joints, and equilibrium. When stimulated, many of these proprioceptors adapt quickly and provide information on instantaneous change and rate of change in muscle activity and body position. Others adapt only slowly to stimulation and therefore provide steady-state information about muscle and body position. Working together they provide the information necessary for coordinated muscle action and movement and the maintenance of posture.

All muscles in the body with few exceptions are arranged in antagonistic pairs of muscles. This arrangement of muscles can be referred to as reciprocal facilitation/inhibition, because whenever one of the pair is facilitated or turned on, its antagonist (or antagonists as there may be several) is automatically inhibited or turned off. Hence, the turning on and turning off are both normal states of muscle function. When a muscle contracts isometrically during muscle monitoring, signals are sent to the "prime mover" (PM) to hold the position of the body part by consciously facilitating the PM. Then as the pressure on the body part (e.g. an arm held horizontal) is increased during muscle monitoring, the muscle sensors (muscle spindle) in the PM respond by a spinal reflex arc referred to as the "load reflex". The load reflex increases the degree of PM contraction, while at the same time inhibiting their antagonists and facilitating their synergists. Synergists are muscles that help the PM in holding the arm up, but are not in their position of optimal mechanical advantage. Synergists contribute much less than the PM to establishing and maintaining this position. A muscle circuit can be defined as the PM and all other muscles, both synergists and antagonists, to which it is "wired" both at the level of the brain and spinal reflex arcs. Figure 1 provides an example of a simplified muscle circuit. More specifically with respect to a muscle circuit, each muscle in the body has antagonists (usually more than one) that oppose its action. The agonist or PM and its antagonist(s) are neurologically wired together via the spindle cells in the belly of these muscles. This neurological wiring is such that when a PM is facilitated (turned on) it sends signals to automatically inhibit (turn off) its antagonist(s) to the same degree it has been facilitated. At the same time, if the load is sufficiently large it facilitates its synergists. In this way, the limb moves in the direction of contraction, unopposed by its antagonist(s), permitting smooth and rapid movement of the limb. Likewise, facilitation of an antagonist will inhibit the PM, as the spindle cells of the antagonist(s) need to inhibit the PM in order to move the limb in the opposite direction from the action of the PM. Referring to Fig. 1 , it illustrates a muscle circuit consisting of an agonist or prime mover (biceps), one antagonist (triceps) and one synergist (brachioradialis). The spindle cell of the PM is wired to both its antagonist, which it inhibits, and its synergist, which it facilitates. Not shown is the reciprocal spindle cell circuitry for the antagonist, the triceps. When the triceps is facilitated, spindle cells in the belly of the triceps send signals to inhibit the biceps and its synergists the brachioradialis.

During a series of muscle contractions and relaxations, information on this series of activity is also sent to subconscious parts of the brain, e.g. the basal ganglia and thalamus, which control "pre-recorded" muscle programs, and the cerebellum where comparisons are made of intended actions and actual actions. If an intended action is to keep the arm held at horizontal, but the arm moves downward due to the increasing pressure of a dynamic load, the subconscious brain centers augment the automatic spinal load reflex and orders additional contraction of the PM to offset movement, thereby helping the arm to remain horizontal. As long as the flow of information from muscle sensors to and from the brain remains "clear" with no interruptions, the muscle can maintain the isometric contraction until the muscle reaches its full power of contraction. If loading continues above this point, the arm will move down as the PM is overpowered by the downward pressure of the dynamic load, resulting in an eccentric contraction.

During muscle testing, the pressure applied is far less force than needed to overpower the PM. A muscle with full neurological integrity should therefore maintain the isometric contraction during muscle monitoring. That is, unless something interferes with the neurological flow of information between the muscle and the central nervous system, the muscle should be facilitated sufficiently to maintain its physical position even under increasing load. This capability of the muscle to maintain an isometric contraction indicates a muscle that can be considered in "balance" with its neurological circuitry. If there is interference or a disruption in the flow of information between a muscle and the central nervous system, the muscle will not be able to coordinate and match its degree of facilitation to the increasing loading taking place during muscle

testing/monitoring. Accordingly, the arm will move downward appearing to fail under the monitoring pressure, resulting in an eccentric contraction. A muscle that fails to maintain the isometric contraction such as by inhibited feedback from muscle spindle cells, tendon and joint sensors or inhibitory feedback from subconscious emotional brain centers, can be described as being "under- facilitated" relative to the pressure being applied. The eccentric contraction of the muscle may be observed simply as the muscle being weak (i.e. failing under the monitoring pressure). However, the muscle is not weak, but rather inhibited or under- facilitated to resist the monitoring pressure.

For muscles to function properly, they require a number of different nutrients, including vitamins, minerals, and trace elements in sufficient concentrations to maintain the required energy production for muscle function. Muscle tissue also requires a variety of amino acids for structural integrity and repair, and to provide energy for proper muscle function. When any of the components of this nutritional matrix is deficient, it may reduce the effectiveness of muscle function. Additionally, the proper ratios and concentrations of the nutrients within this matrix are necessary for maintenance of on- going muscle function. One of the problems of aging is a decrease in the effectiveness with which the body both assimilates and utilizes nutrients and thus muscle function is often affected by these nutrient imbalances due to these natural processes.

While there may be a tremendous amount of information available regarding traditional techniques and therapies for improving muscle function, the great majority of this information relates to electrical or chemical methods of treatment. Muscle stimulation by NMES has proven to provide certain benefits. Providing a patient with an improved diet and/or supplementation of vitamins, minerals, and other nutrients that were shown to be lacking has also proven to provide certain benefits.

However, nutritional supplementation, stimulation and exercise alone are often not enough to strengthen "weak" muscles due to inhibition of the muscle via muscle spindle cell, Golgi tendon organ and Golgi ligament organ receptors whose job it is to "protect" the structural integrity of the muscle and its related tendons and ligaments should tension on the muscle exceed a threshold level. Often injury or even simply slipping or an unusual activity can "unset" this threshold for inhibition such that the Spindle cell, Golgi tendon organ or Golgi ligament organ receptors now inhibit the muscle action long before there is any likelihood of damage to the muscle, tendon or ligament. Thus, when the person now tries to use this muscle it appears "weak" as it just cannot develop much power.

A muscle in this "inhibited" state responds very poorly to normal rehabilitation even using the electrical stimulating devices because according to Wolf s Law in physiology, in order to build more strength, and muscle must develop more tension. This is because tension is the signal for the muscle to make more muscle fibers, which is what increases its strength. If, however, the muscle is inhibited at a specific level of tension (even one that does not approach tension that would be harmful) by the "unset" Spindle cell, Golgi tendon or Golgi ligament organ receptors, this inhibition prevents the development of further tension, and thus the muscle is not given the signal to make more muscle fibers. Muscles inhibited in this way, even when exercised regularly can never get stronger, and thus present as chronic muscle problems. Until the "unset" receptors are "reset", this problem will persist.

Thus, traditional techniques and therapies for improving muscle function still may not provide optimal results for many patients that have certain imbalances or maladies manifesting in poor muscle function. Therefore, there is still a need to provide an alternative form of treatment and therapy for muscle tissue that does not rely upon traditional techniques/therapies.

SUMMARY OF THE INVENTION

In accordance with the present invention, a device and method are provided for therapy and treatment of biological tissue such as muscle, tendon, ligament, and nerve tissue, by use of a device and method in which tissues and associated proprioceptors and neuromuscular feedback loops are exposed to therapeutic resonant frequency patterns (TRFP) or therapeutic frequency resonance patterns, and/or TRFPs are transmitted to muscle and muscle proprioceptors of a patient. Disease states that may be treated or ameliorated using the devices and methods of the present invention include multiple sclerosis, Parkinson's disease, cerebral palsy, amyotrophic lateral sclerosis (Lou Gehrig's Disease, ALS), muscular dystrophy, and Graves' disease, spinal-bulbar muscular atrophy, myasthenia gravis, Huntington's Disease, polymyositis, Lambert-Eaton syndrome, monomelic amyotrophy, progressive bulbar palsy, lower motor neuron weakness, upper motor neuron weakness, peripheral neuropathy, diabetic peripheral neuropathy, spinal cord injuries, botulism, Guillain Barre syndrome, and Pompe disease. Devices and methods of the present invention may also be used in coordination with rehabilitation, physical and occupational therapy, osteopathic and chiropractic treatment, and sports training.

According to the present invention, it may be considered a device and method in which tissues and associated proprioceptors and neuromuscular feedback loops are exposed to therapeutic resonant frequency patterns (TRFP) or therapeutic frequency resonance patterns and/or TRFPs are transmitted to, or interact with, a patient, in which the resonance patterns originate from many types of bioactive substances or resonance domains, including vitamins, minerals, herbs, amino acids, proteins, nucleic acids, fatty acids, nutritional supplements, homeopathic preparations. The particular combination of the bioactive substances or domains used in the present invention is designed to achieve a specific effect and may be referred to as a "muscle formula", an "oxygen formula", or any other formula as explained further below. Each formula includes therapeutic frequency resonance patterns or a set of specific resonant frequencies based on, for example, the physical properties of constituent substances. These frequency-based properties as transferred to the device of the invention are artifacts of the formula, and can be referred to as, therapeutic resonant frequency patterns and/or therapeutic resonant fingerprints.

The resonance frequency patterns are or may be able to be identified, captured, and ultimately delivered or transferred to a substrate of the device, which may include a mineral matrix layer. The process or means by which the resonant frequency patterns are delivered or transferred to the device can be described as methods of transfer by imprinting, infusing, entraining, or imaging. As used hereinafter, the term "transfer" is intended to include each or selected ones of these methods of transfer. The term "imprint" or "imprinted" as used hereinafter is intended to describe the physical state of the device of the invention after transfer of the resonant frequency patterns. The resonant frequency of a formula may be transferred the substrate using electromagnetic and/or mechanical waves such as acoustic waves. The imprint of the therapeutic resonant frequency patterns is a durable and lasting condition for the device that may last months or even years.

A passive or active excitement of an imprinted device induces a therapeutic response from a patient that simulates the physical application of the formula imprinted on the device. For example, a device imprinted with the resonant frequency patterns of a formula may be placed proximate to a muscle or muscle group of a patient. The imprinted device is excited to transmit the resonant frequency pattern of the formula from the imprinted device to the muscle. Thus, if the formula includes various nutraceuticals, then the muscle produces a response as if the muscle were physically receiving the various nutraceuticals by one or more conventional methods. This induced response provides a tangible and measurable therapeutic benefit to the patient that does not require the physical application or ingestion of a substance in the patient's body. Further, an imprinted device is or may be reusable, which may greatly reduce costs of treatment.

The mineral matrix may comprise minerals/elements including, but not limited to, calcium, potassium, magnesium, silica, boron, carbon, and nitrogen. The mineral matrix may be applied to a reverse side of a carrier or other substrate layer, such as a small piece of silicone, glass, or a thermoplastic material. The substrate with or without mineral matrix is capable of retaining the combined or master frequency resonance patterns for a period of time. The resonance frequencies retained by the mineral matrix can be transmitted to a patient to enhance muscle, tendon, ligament, and nerve function, to decrease the normal rehabilitation time of a damaged muscle/tendon/ligament/nerve, and may otherwise provide therapeutic benefits for muscle tissue dysfunction.

All molecules, including biologically-active molecules, store energy in a wide range of modes (including electronic, vibrational, rotational, and nuclear magnetic energy states), and exchange it with the environment via resonant frequencies spanning a correspondingly large range of the electromagnetic spectrum (from ultraviolet, visible and infrared light through microwaves, radio waves, and possibly even extremely low frequencies). Energy exchanged via higher-energy interactions is typically quickly dispersed in dense media as heat, though metastable low-energy states can persist for extended periods of time. The detailed mechanisms by which resonant electromagnetic energy exchange with tissue can affect underlying biological processes are not fully understood, though there is growing evidence that cellular chemistry and intra- and intercellular communication and signaling can be affected by electromagnetic stimuli in these energy regimes.

According to one theory, the human body may respond directly to the frequencies or molecular resonance of bioactive substances including, but not limited to, nutrients, hormones, neurotransmitters, neuropeptides, and cytokines. Such a response might be mediated by sympathetic resonance, which does not require actual contact of the substances with the body. An analogy is the tuning-fork effect, in which a first tuning fork, vibrating at its resonance frequency, will cause another tuning fork of the same frequency to vibrate at the same frequency, even though there is no direct physical contact between the tuning forks (in this case, in air, the resonance is mediated by pressure waves in the acoustic medium). Via a corresponding phenomenon, molecular resonance might transfer energy between similar molecules or similar molecular subunits, even when they are not touching. The manner in which resonant frequencies mediate interactions among nutrients and other molecules within the body is a topic of current research.

A recent study conducted in the United Kingdom involved research on how molecules interact via their emitted or radiated frequencies. This study evolved from successful treatments of people with electromagnetic sensitivity. In the study, clinical data supported a conclusion that a chemical in a sealed vial or ampoule can trigger an allergic reaction, for example, without the substance being introduced into the patient's body or touching their body. Thus, a reasonable mechanism to explain these phenomena is that the molecules in the sealed vial when placed near the body transmit their specific frequencies to the body via the weak electromagnetic fields that they emit, which in turn interacts with the resonance frequencies of molecules within the body. See Choy, R.V.S., Monro, J.A. and Smith, C.W., Electrical Sensitivities in Allergy Patients; Clinical Ecology 4(3): 93- 102, 1987; see also Smith, C.W., Electromagnetic Effects in Humans; In Biological Coherence and Response to External Stimuli, Herbert. Froelich (ed.) Springer- Verlag, Berlin, pp. 205-232, 1988.

Another study examined the effect of exposure of rats to electromagnetic waves related to the resonance frequency pattern of morphine. Rats exposed to these

electromagnetic waves showed decreased nocioception (sensitivity to pain stimuli) compared to rats exposed to nonspecific frequencies, rats exposed both to morphine - specific frequencies and a morphine suppressor, and a control group, though the decrease was not as great as for rats treated with morphine by injection. See Verginadis, 1.1., Simos, Y.V., Velalopoulou, A.P., Vadalouca, A.N., Kalfakakou, V.P., Karkabounas, S.C. & Evangelou, A.M., Analgesic effect of the electromagnetic resonant frequencies derived from the NMR spectrum of morphine, Electromagnetic Biology and Medicine, 31(4): 275-284, 2012.

In summary, the frequencies radiated by the molecules as well as the chemicals themselves can disrupt regulatory systems, or restore these systems to normal operation. These phenomena fall into the category of external or exogenous homeopathy in which the remedy does not touch the body, yet produce a specific physiological effect, e.g. an allergic reaction, or the elimination of an allergic reaction. This provides a model for how the frequency resonance patterns of the nutrients in the muscle formula may be transmitted to the tissues of the muscles, tendons, ligaments, and nerves, and that this exposure can bring the muscle back into normal function, even when the device of the present invention is not physically touching the body or placed directly on the muscle being treated.

One preferred embodiment of the device of the present invention incorporates a substrate of a suitable material upon which the therapeutic resonant frequency patterns of a nutraceutical formula are imprinted. Suitable materials include, but are not limited to, glasses, ceramics, minerals, plastics, semiconductors, and piezoelectric materials, in pure, mixed and doped forms, with crystalline, polycrystalline, glassy, amorphous, or sintered structure. The device in this embodiment may be 25-75 mm in length and width, and 2 mm thickness.

Similarly, in another preferred embodiment, a material may be applied to or embedded within a carrier or substrate layer. The material may include a liquid, gel, or slurry containing a mineral matrix mixed with an adhesive glue. As mentioned, the mineral matrix may include, but is not limited to, sodium, magnesium, calcium, potassium, boron, chloride, sulphate, bicarbonate, alumina, and silica, and combinations thereof. The mineral matrix is mixed with adhesive glue. The coating containing the mineral matrix is applied at a thickness of approximately 0.25 mm. The mineral matrix makes up approximately 50% by weight of the mineral matrix/glue mixture. When completed, the chip according to this preferred embodiment is approximately 26 mm X 22 mm in length/width, and 0.5 mm thick. In some embodiments, it will be appreciated that the coating containing the mineral matrix may not be applied to the chip.

Another preferred embodiment of the device of the present invention includes a relatively small carrier or substrate layer, and a coating applied to one side of the substrate. One convenient sized carrier or substrate that can be used is a standard

computer/information chip, similar to radio-frequency identification (RFID) chips that may be used as electronic sales tags that are programmed with basic information such as the cost of an item, manufacturer, inventory data, etc. A computer chip can be used as a convenient substrate for a number of reasons. First, these chips are mass produced, and are relatively inexpensive. Secondly, these chips are relatively small, yet are of a size that provides adequate surface area for applying the mineral matrix. Thirdly, the chips are structurally robust and are made of materials that readily accept and hold an applied coating. While a computer chip provides a good solution as a carrier/substrate layer, it should be understood that other materials could be used.

In another aspect of the invention, use of a computer chip also allows the device of the invention to have the capability of being electronically "tagged" in order to provide product identification, inventory control, and other inventory or sales functions.

Therefore, the computer chip could be programmed/encoded with the desired information in order to provide the desired inventory or sales function. The coating is applied to the side of the chip that does not contain the circuitry, and in the case of using a holographic chip, the coating is applied to the side of the chip that does not contain the hologram .

Also in accordance with the preferred embodiment, the resonance frequencies of a formula may be embedded within the substrate or mineral matrix. First, the formula is prepared by grinding and mixing the constituent components of the formula. Listed below are chemicals/compounds/plant types that may be used within the formula. These cheniicais/compounds/plant types may be used in different quantities and/or

concentrations within the formula to achieve specific objectives for the treatment to be conducted. Although a specific listing of components is provided, it should be understood thai the formula can incorporate a host of other components, and therefore this listing should not be considered as exclusive. These components may include:

L-Phenylalanine

L-Glutamine

L-Carnitine

L-Taurine

Betatene or other mixed carotenoids

Magnesium stearate or gluconate

Lemon or citrus bioflavonoids

Lithium

Thiamine (Vitamin Bl)

Riboflavin (Vitamin B2)

Nicotinamide (Vitamin B3)

Calcium pantothenate (Vitamin B5)

Pyridoxine (Vitamin B6)

Methylcobalamin (Vitamin B 12)

Folic acid or L-Methylfolate

Biotin

Ascorbic acid (Vitamin C)

Rosehips

Vitamin D

Vitamin E (preferably, d-alpha)

Inositol

Choline

Lecithin

Calcium gluconate

Magnesium stearate or gluconate

Silica

Iron gluconate, picolinate or glycinate

Zinc gluconate or picolinate

Manganese gluconate

Chromium sulphate or picolinate

Potassium iodide

Minerals D-Ribose

Hyaluronic acid

Chondroitin sulphate

Glycosylated glucosamine

Collagen

Creatine monohydrate

Kelp

Alfalfa,

White Willow Bark Extract,

and combinations of these components.

The lithium may include organic sources of lithium, such as lithium found in brewer's yeast (Saccharomyces cerevisiae), or lithium in mineral form (e.g. lithium orotate).

The D vitamin may be supplied as vitamin D3 (cholecalciferol) and/or vitamm D2 (ergocalciferol).

The minerals may include any elements selected from: Ag, Al, As, Au, B, Ba, Be, Bi, Br, C, Ca, Cd, Ce, CI, Co, Cr, Cs, Dy, Er, Eu, F, Fe, Ga, Gd, Ge, H, Hf, Hg, Ho, I, In, Ir, K, La, Li, Lu, Mg, Mn, Mo, N, Na, Nb, Nd, Ni, O, Os, P, Pb, Pd, Pr, Pt, Re, Rh, Ru, S, Sb, Sc, Se, Si, Sm, Sn, Sr, Ta, Tb, Te, Th, Ti, Tl, Tm, V, W, Y, Yb, Zn, and Zr.

Preferably, these minerals are used or added to other components of the muscle formula as a colloidal suspension.

Lemon bioflavonoids are anthoxanthins (flavones and flavonols) that may include isoflavonoids derived from 3~phenylchrornen~4~one (3-phenyl-l,4-benzopyrone) and neoflavonoids, derived from 4-phenylcoumarine (4-phenyl-L2-benzopyrone).

The collagen proteins may be type I or type 11, or a combination thereof.

Alfalfa, also called lucerne, may include flowering plants in the pea family Fabaceae.

Kelps include any genera of brown algae, Phaeophyceae, in the order

Laminariale .

Another embodiment of the invention is a composition comprising at least two components making up the muscle formula, including L-phenylalanine, L-glutamine, L- carnitine, L-taurine, betatene , lemon bioflavonoids, lithium, thiamine (vitamin BI), riboflavin (vitamin B2), nicotinamide (vitamm B3), calcium pantothenate (vitamin B5), pyridoxine (vitamin B6), methyl cobalamin (vitamin B12), folic acid, biotin, ascorbic acid (vitamin C), rosehips, vitamin D, vitamin E (preferably, d-alpha), inositol, choline, lecithin, calcium gluconate, magnesium, stearate, silica, iron gluconate, zinc gluconate, manganese gluconate, chromium sulphate, potassium iodide, minerals, D-ribose, hyaluronic acid, chondroitin sulphate, glycosylated glucosamine, collagen, creatine monohydrate, kelp, alfalfa and combinations of these components. These compositions may be dissolved or suspended in an alcohol, such as an aqueous alcohol solution, In certain embodiments, the alcohol of these compositions is ethanoi.

After preparation of the formula, the therapeutic resonant frequencies of the formula can be imprinted on the substrate by one of several methods as described below. In many cases, the mixture is first prepared for imprinting by dissolution in an aqueous ethanoi solution . In an exemplary method, a sample of the aqueous alcohol / nutraceutical solution is placed into a quartz chamber. The sample might contain 5 - 500 ml of the nutraceutical solution. The quartz chamber containing the nutraceutical solution is placed into an apparatus in which the magnetic field generated by a pulsed electromagnetic field (PEMF) device passes through the quartz chamber, to illuminate a target substrate. The PEMF is activated, and the target exposed for a period of time; the time-varying magnetic field serves as a carrier wave to transfer the resonant frequency pattern of the nutraceutical formula to the substrate target. The resonant frequency pattern has been shown to be retained or imprinted on the substrate.

In another embodiment of the imprinting method , a sample of the aqueo us alcohol solution is placed into a first quartz chamber (the "master crystal"). The first quartz chamber containing the solution is then placed into an apparatus having a ruby laser located above the first quartz chamber. The first quartz chamber may be, for example, a chamber that holds a 5ml amount of the muscle formula solution. A second quartz chamber is provided, and has therein a buffered salt solution comprising selected salts, comprising, but not limited to, sodium, magnesium, calcium, chloride, nitrates, silica, or bicarbonates, or combinations thereof. This second quartz chamber also includes a quartz crystal placed in the quartz chamber. The second quartz chamber is provided directly below the first quartz chamber. The laser is activated, and the laser results in excitation of the components of the muscle formula solution so that the frequency resonance characteristics of the muscle formula solution are transferred to the quartz crystal in the second chamber. The transferred frequency resonance characteristics are retained in the quartz crystal in the form of a combined frequency resonance pattern transferred to the quartz crystal. The buffered salt solution stabilizes this frequency resonance pattern transferred to the quartz crystal. Accordingly, this process transfers into the quartz crystal/salt solution the combined frequency resonance pattern of each component of the muscle formula into a single frequency resonance matrix of the whole muscle formula (MF), hereinafter referred to as the MF frequency resonance matrix. This quartz crystal- salt solution programmed with the MF frequency resonance matrix is referred to as the master crystal, and it has been shown to maintain this frequency resonance matrix over time.

In order to transfer the MF frequency resonance matrix to a the device of the present invention, the ruby laser is arranged to send a pulse of light directed to shine through the master crystal onto each individual computer chip of a roll of coated computer chips that will move past the tip of the master crystal at a specific speed. When the laser is turned on, as each computer chip passes the tip of the master crystal, the pulse of laser light transfers the resonance MF frequency matrix into the mineral matrix previously coated onto the chip. A thin plastic film is then coated on the mineral matrix layer to provide additional protection. The mineral matrix retains the resonance MF frequency matrix, and therefore can later serve as a "transmitter" of the retained frequencies during use of the device.

The foregoing describes some embodiments by which therapeutic resonant frequency patterns can be imprinted within a suitable substrate or matrix. The present invention encompasses other substrates capabl e of retaining such imprints, and other methods of imposing the imprinted pattern. Other unprintable substrates include materials such as glasses, ceramics, minerals, plastics, semiconductors, piezoelectric materials, gels and viscous materials, in pure, mixed and doped forms, with or without an associated or embedded mineral matrix, with or without surface treatments, and having crystalline, polycrystalline, glassy or amorphous structure. Other methods of imposing or imprinting a therapeutic resonant frequency pattern include techniques based on mechanical, acoustic or electromagnetic waves, and plasma transduction, and any combination of individual techniques.

According to the method of the present invention, the frequency resonance matrix of the formula can be deli vered to the body in many ways. According to a first method, the imprinted device may be applied directly to the body for a period of time, while the person performs certain activities that activate specific muscles involved in different patterns of motor activity, thereby re -integrating muscle dysfunction. According to this method, the device may be applied directly over the targeted group of muscles to be treated, and then directed exercises are performed to achieve the therapeutic effect. For example, this direct application method can be achieved by placing the chip on the skin over the affected muscle (such as a bicep muscle), and then the bicep muscle is taken through three series of contractions. The targeted muscle(s) are then directed to be held in their most contracted position for approximately 5 seconds while a load is applied to the body part that is supported by the targeted muscle(s). The targeted muscle(s) are then relaxed for a period of approximately 30 seconds, and the targeted musc!e(s) is then directed to be isometrically contracted or locked for approximately another 5 seconds, while increasing pressure is applied against the isometrically contracted or locked muscle. The cycle may be repeated a third time. Through Electromyographic (EMG) testing (described below), it has been shown that this method can reset muscle proprioception. After a period of approximately 2 minutes, the integrity of muscle function can be re- checked to confirm that the muscle proprioception has been reset. If successful, the targeted muscle(s) should now isometrically contract or lock strongly against monitoring pressure, yet should be able to be sedated using spindle cell, golgi tendon organ and golgi ligament organs sedation techniques.

The frequency resonance pattern of the imprinted device may also be actively excited. In the embodiments described above, the imprinted device is used passively and is engaged by the manipulation of the targeted muscle(s). In other embodiments, a delivery mechanism is configured to actively excite the muscle chip or imprinted device such that the muscle chip or imprinted device produces the frequency resonance matrix of the muscle formula. Similar to the passive systems, the active excitation of the device or muscle chip is used to deliver a therapeutic benefit to a patient. In one preferred embodiment, the affected tissue is exposed to the magnetic field output of a pulsed electromagnetic field (PEMF) device which first passes through an imprinted device. The affected muscle is taken through three cycles of contraction as described above to reset proprioception.

According to the theory supporting the therapeutic benefits of the present invention, muscle imbalance or dysfunction can be caused by the lack of or incoherence of certain frequencies needed to maintain normal function. Direct activation or dynamic muscle activity exposes the muscle imbalance to therapeutic intervention. The device imposes a harmonic resonance field to replace or supplement the 'missing' or 'distorted' frequencies involved in the muscle imbalance. Thus, the affected muscle can be brought back into normal function by transferring the resonance pattern retained in the imprinted device to the muscle, thereby resetting muscle function.

Treatment by use of the invention can be enhanced if the caregiver has a working knowledge of muscle function, including how to position muscles for proper muscle monitoring. Treatment can be further enhanced if the caregiver has a working knowledge of muscle monitoring or muscle testing techniques.

The de vice and method of the present invention can rapidly reset muscle proprioception to restore normal muscle function, often resolving even long-term chronic pain and dysfunction. The device and method may further reduce days of stay in a hospital, reduce rehabilitation times, reduce need for many operations, and save the hospital and insurance systems time and resources, as well as to save patients out of pocket costs. This invention is also non-invasive with only minimal side- effects. Through IRB-approved university research, it has been found that muscle improvement can take place, often within seconds up to a period of 30 minutes, and these benefits appear to be long-lasting. Therefore, embodiments of the present invention may serve as a delivery mechanism for medicine, just as capsules, syringes, IV drips, and dermal patches deliver medicine.

In embodiments of the present invention, the resonance frequency of a particular layer may depend on its physical attributes. For example, the size of the layer influences the resonance frequency. In crystals such as quartz, how the crystal is cut influences the resonance frequency. In an "AT" type of crystal cut, the crystal 's x axis is inclined by approximately 35° relative to the z axis. This cut results in a crystal that is less sensitive to fluctuations in temperature. Additionally, the material that the layer is comprised from influences the resonance frequency.

In some embodiments, a delivery mechanism is used to excite the device layers to produce the resonance frequency and/or harmonics thereof via the phenomenon of sympathetic resonance. Delivery mechanisms generally produce two types of waves to excite the device: electromagnetic waves and mechanical waves such as acoustic waves. These waves interact with attributes of the device such that the device produces the resonance frequency . For example, in some embodiments the device is a piezoelectric crystal and the delivery mechanism imposes an electric field on the crystal which causes the crystal to change shape. When the delivery mechanism ceases to impose an electric field, the crystal reverts back to its original size and shape, and the crystal emits a resonance frequency. This resonance frequency and harmonics thereof may then be implemented to a user for therapeutic benefit.

Considering the above summary of the invention, on one aspect, the invention may be consid ered a method for treatment of biological tissue by application of therapeutic frequency patterns, said method comprising: (a) providing a therapeutic frequency resonance pattern device, said device comprising a substrate layer having at least one resonance frequency; (b) positioning a muscle tissue of a patient having a potential imbalance in a state of contraction; (c) confirming an indicator change in the muscle; (d) placing said device in proximity to the muscle; (e) exciting said at least one resonance frequency of said substrate using a wave; (f) again placing the muscle in a state of contraction; (g) applying pressure to the muscle; (h) removing said device from the patient; and (i) retesting the muscle to confirm a therapeutic effect has been achieved.

In another aspect the invention, the method of treatment of biological tissue may comprise: (a) providing a therapeutic resonant frequency pattern device, said device comprising a substrate layer having at least one imprinted resonant frequency; (b) positioning a muscle tissue of a patient having a potential imbalance in a state of contraction; (c) challenging the muscle system to test for imbalance; (d) placing said device in proximity to the muscle; (e) exposing said device and muscle system to an oscillating wave; (f) again placing the muscle in a state of contraction; (g) applying pressure to the muscle; (h) removing said device from the patient; and (i) retesting the muscle to confirm a therapeutic effect has been achieved.

According to this first aspect, there are a number of other features of the invention that may be considered and included, either alone or in combination. More specifically, according to the method, the wave may comprise at least one of a mechanical wave and an electromagnetic wave; the wave may comprise a waveform, wherein said waveform is at least partially comprised of at least one of a sine wave, a square wave, a triangle wave, a saw-tooth wave, and any other waveform commonly known in the art, or waveforms of arbitrary shape constructed to efficiently convey therapeutic resonant frequency patterns to affected tissue; the substrate of said device may comprise one of piezoelectric crystal, quartz, silicon, plastic, glass, saline solution, mineral solution, synthetic crystal, sapphire, moissanite, natural crystal, gem stone, ceramic, viscous substance, lithium tantalate, lithium niobate, lithium borate, berlinite, gallium arsenide, lithium tetraborate, aluminium phosphate, bismuth germanium oxide, poly crystalline zirconium titanate ceramics, high- alumina ceramics, silicon-zinc oxide composite, dipotassium tartrate, gallium phosphate, langasite, langanite, langanate, leaded glass comprising 18 to 40 % lead oxide determined on a weight basis, and doped variants and/or combinations thereof.

According to the first aspect, there are yet further features of the invention that may be considered and included, either alone or in combination including wherein the device may further comprise a mineral matrix layer, and a protective layer placed over said mineral matrix layer; the method may further include providing a delivery mechanism in proximity to said device, said delivery mechanism excites said at least one resonance frequency from said substrate layer using said wave; may further include placing said device in proximity to the muscle further includes placing a patch over said device to secure said device relative to the muscle; wherein said patient may have at least one of multiple sclerosis, Parkinson's disease, cerebral palsy, amyotrophic lateral sclerosis (Lou Gehrig's Disease/ ALS), muscular dystrophy, and Graves' disease; said substrate may comprise a crystal cut, wherein said crystal cut is at least one of AT, SC, BT, IT, FC, AK, CT, DT, SL, GT, E, 5°X, MT, ET, FT, NT, XY, H, J, RT, SBTC, TS, X 30°, LC, AC, BC, NLSC, Y, X, and combinations thereof; wherein said delivery mechanism may produce said wave through a range of frequencies; and said range of frequencies may be between approximately 0.5 Hz and 1 PHz.

According to the first aspect, there are further features of the invention that may be considered and included, either alone or in combination including wherein said delivery mechanism is a pulsed electromagnetic field generator; wherein said substrate layer is imprinted with a frequency resonance pattern of oxygen; further comprising a second therapeutic frequency resonance pattern device, said second device comprising a second substrate layer; said second substrate layer is imprinted with a frequency resonance pattern of oxygen; further comprising: and a delivery mechanism that excites said at least one resonance frequency from said substrate layers of said devices using said wave, said delivery mechanism having a cable for delivering said wave. It will be appreciated that multiple frequency patterns may be imprinted on the same device. For example, an oxygen or 0₂ formula and a nutraceutical formula may both be imprinted on the same substrate. Further, different imprinted substrates may comprise different formulas.

Considering the above summary of the invention, in another aspect, the invention may be considered a system for treatment of biological tissue by application of therapeutic frequency patterns, said system comprising: (a) a therapeutic frequency resonance pattern device, said device comprising a substrate layer having at least one resonance frequency; (b) a patient having a muscle in a potential state of imbalance during contraction, wherein said device is proximate to said patient; and (c) a wave in proximity to said device, wherein said wave excites said at least one resonance frequency of said substrate to provide therapeutic benefit to said muscle.

According to this second aspect, there are a number of other features of the invention that may be considered and included, either alone or in combination. More specifically, according to the system, said wave may comprise at least one of a mechanical wave and an electromagnetic wave; said wave may comprise a waveform, wherein said waveform is at least one of a sine wave, a square wave, a triangle wave, a saw-tooth wave, and any other waveform commonly known in the art, or waveforms of arbitrary shape constructed to efficiently convey therapeutic resonant frequency patterns to affected tissue; said substrate of said device may comprise one of piezoelectric crystal, quartz, silicon, plastic, glass, saline solution, mineral solution, synthetic crystal, sapphire, moissanite, natural crystal, gem stone, ceramic, viscous substance, lithium tantalate, lithium niobate, lithium borate, berlinite, gallium arsenide, lithium tetraborate, aluminium phosphate, bismuth germanium oxide, poly crystalline zirconium titanate ceramics, high- alumina ceramics, silicon-zinc oxide composite, dipotassium tartrate, gallium phosphate, langasite, langanite, langanate, and leaded glass comprising 18 to 40 % lead oxide determined on a weight basis, and doped variants and/or combinations thereof; said device may further comprise a mineral matrix layer, and a protective layer placed over said mineral matrix layer; said system may further comprise a delivery mechanism in proximity to said device, said delivery mechanism excites said at least one resonance frequency from said substrate layer using said wave; said system may further comprise a patch placed over said device to secure said device relative to the muscle; said patient may have at least one of multiple sclerosis, Parkinson's disease, cerebral palsy, amyotrophic lateral sclerosis (Lou Gehrig's Disease/ ALS), muscular dystrophy, and Graves' disease; and said substrate of said device may further comprise a crystal cut, wherein said crystal cut is at least one of AT, SC, BT, IT, FC, AK, CT, DT, SL, GT, E, 5°X, MT, ET, FT, NT, XY, H, J, RT, SBTC, TS, X 30°, LC, AC, BC, NLSC, Y, X, and combinations thereof.

According to the second aspect, there are further features of the invention that may be considered and included, either alone or in combination including wherein said delivery mechanism is a pulsed electromagnetic field generator; wherein said substrate layer is imprinted with a frequency resonance pattern of oxygen; further comprising a second therapeutic frequency resonance pattern device, said second device comprising a second substrate layer; said second substrate layer is imprinted with a frequency resonance pattern of oxygen; further comprising: and a delivery mechanism that excites said at least one resonance frequency from said substrate layers of said devices using said wave, said delivery mechanism having a cable for delivering said wave. For example, an oxygen or 0₂ formula and a nutraceutical formula may both be imprinted on the same substrate. Further, different imprinted substrates may comprise different formulas.

Considering the above summary of the invention, in another aspect, the invention may be considered a system for treatment of biological tissue by application of therapeutic frequency patterns, said system comprising (a) a therapeutic frequency resonance pattern device, said device comprising a substrate layer having at least one resonance frequency; (b) a wave delivery mechanism producing a wave in proximity to said device, wherein said wave excites said at least one resonance frequency of said substrate to provide therapeutic benefit to a patient having a muscle in a potential state of imbalance during contraction; and (c) a pulsed electromagnetic field generator having a cable positioned about said device in a coil, said pulsed electromagnetic field generator excites said at least one resonance frequency from said substrate layer using said wave.

According to the third aspect, there are further features of the invention that may be considered and included, either alone or in combination including further comprising a second therapeutic frequency resonance pattern device, said second device comprising a second substrate layer, wherein said wave excites said at least one resonance frequency of said second substrate to provide therapeutic benefit to said muscle, and said pulsed electromagnetic field generator excites said at least one resonance frequency from said substrate layer using said wave; and wherein: said second substrate layer is imprinted with a frequency resonance pattern of oxygen.

BRIEF DESCRIPTION OF THE DRAWINGS

Figure 1 is a simpl ified schematic diagram of muscle circuit as mentioned above.

Figure 2A is an exploded perspective view of the device of the present invention in a preferred embodiment.

Figure 2B is an exploded perspective view of the device of the present invention in another preferred embodiment.

Figure 3 is a simplified flow diagram of the method of the present invention in a first embodiment of the method.

Figure 4A is a simplified flow diagram of a method of manufacture for the device of the present invention. Figure 4B is a simplified flow diagram of a method of manufacture for the device of the present invention.

Figure 5 is a graphical representation of data obtained during proof-of-concept testing showing improvements in muscle function.

Figure 6 is another graphical representation of data obtained during proof-of- concept testing showing improvements in muscle function.

Figure 7 is another graphical representation of data obtained during proof-of- concept testing showing improvements in pain and mobility after an extended period of time.

Figure 8 shows the percentage change in peak force observed between the test conditions, results from the interim analysis of the Pilot Study described in the Examples section of this disclosure. A significant difference was observed in change in peak force between experimental and control subjects, p<0.05. Additionally, the Threshold represents a meaningful change in force, based upon published literature.

Figure 9 shows the mean EMG Root Mean Square for the three test conditions, results from the interim analysis of the Pi lot Study described in the Examples section of this disclosure. A significant difference was obser ed between Chip Applied and Post "Treatment" for Experimental Subjects, p<0.05.

Figure 10 shows the relationship between the peak force and the mean EMG Root Mean Square for the three test conditions, results from the interim analysis of the Pilot Study described in the Examples section of this disclosure. A reasonable linear relationship was observed for peak force and mean EMG RMS.

Figure 11 shows an example of an individual relationship between the peak force and the mean EMG Root Mean Square for the three test conditions, experimental subject 10, anterior deltoid muscle, results fro the interim analysis of the Pilot Study described in the Examples section of this disclosure.

Figure 12A shows two therapeutic frequency resonance pattern devices stacked on top of each other and placed directly on a patient.

Figure 12B shows two therapeutic frequency resonance pattern devices and a delivery mechanism having a coil or two electrodes, wherein the two devices and the coil or electrodes are placed in a housing, which is then positioned on a patient.

Figure 13A shows a therapeutic resonant frequency pattern device placed over a muscle or muscle group of a patient. Figure 13B shows a therapeutic resonant frequency pattern device and a delivery mechanism having a coil or two electrodes, wherein the device and the coil or electrodes are placed in a housing, which is then positioned over a muscle or muscle group of a patient.

DETAILED DESCEU ΡΊΊΟΝ

Referring to Fig. 2A, a preferred embodiment of the device 10 of the present invention is shown in an exploded perspective view. In one aspect, the device can be generally referred to as a therapeutic frequency resonance pattern delivery device or means. This figure illustrates the device 10, having a substrate or carrier layer 12, a mineral matrix layer 14, and a protective layer 16. As described, the substrate or carrier layer 12 may be a computer chip. The mineral matrix layer 14 is applied to one side of the carrier layer 12, and is mixed with adhesive glue. The mineral matrix layer 14 is applied at a thickness of approximately 0.25 mm. The mineral matrix makes up approximately 50% by weight of the mineral matrix/glue mixture. When completed, the device 10 according to this preferred embodiment is approximately 26 mm X 22 mm in

length/width, and 0.5 mm thick. Optionally, the carrier layer 12, if a

computer/holographic chip are used, may further include information

programmed/recorded on the chip for sales and inventory purchases, or to otherwise identify the chip. The protective layer 16 may be a thin plastic film applied over the mineral matrix layer 14 to provide protection for the layer 14. This thin plastic film will not degrade or otherwise hinder the transmission capability of the mineral matrix layer 14. The device 10, which utilizes a computer chip as the substrate, is shown as having a rectangular shape. However, which also be understood that the device 10 can be other shapes, such as round, oval, or any other shape which makes use of the device convenient when attached to a patient.

Referring to Fig. 2B, an alternative embodiment of the device 10 is provided where the substrate 2, the mineral matrix layer 14, and the protective layer 16 have a circular shape. Thus, the components 12, 14, 16 may be disc shaped and assembled into a device 10 that also has a disc shape. It will be appreciated that the components 12, 14, 16 may also have other shapes such as polygonal or amorphous shapes, and the components 12, 14, 16 may have shapes that differ from each other.

Referring to Fig. 3, a simplified flow diagram is provided for explanation of one preferred embodiment of the method of the invention. At block 20, as a first step, a caregiver locates a muscle imbalance. At block 22, the affected body part is positioned so thai the targeted muscle is in the furthest state of contraction. This contracted position is held for approximately 5 seconds. At block 24, the muscle is tested for an indicator change by applying a steady, consistent pressure. If there is no indicator change, that is, if there is no observed, eccentric contraction, "unlocking", or failure of the muscle, then at block 26, the patient continues to be checked/evaluated for other muscle imbalances. If there is an observed, eccentric contraction or "unlocking", then at block 28, the device 10 is placed on the central vessel 8 (the navel), or in other embodiments, the device 10 is placed over or in proximity to the particular tissue, muscle, or muscle group. At block 30, the targeted/imbaianced muscle is again placed in its furthest state of contraction. At step 32, increasing pressure is applied for approximately 5 seconds to activate the muscle fibers, and the associated spindle cells, golgi tendon organs and golgi ligament organs. This activity of block 32 is repeated a number of times, shown at block 34. During this repeated application of pressure over 5 second time periods, the caregiver should observe improved muscle function. In clinical trials, it is been shown that repeating this activity three or four times has been adequate to resolve many muscle imbalance problems. At step 36, the device 10 is removed from the patient, and the muscle is allowed to rest for a period of time, preferably for about 2 minutes. At step 38, the muscle is retested by placing the muscle back to its furthest state of contraction. If the procedure has been successful, the targeted muscle(s) should now isometrically contract lock strongly against monitoring pressure.

The method described in reference to Fig. 3 prescribes placement of the device 10 on the navel; however, it should be understood that the device 10 can be placed upon other body parts, to specifically mciude those muscles and muscle groups that have been found to have an imbalance. Additionally, although the method described prescribes application of repeated and progressi vely increasing pressure o ver 5 second time periods, other methods of the present invention may include other protocols for application of pressure over other time periods, as well as the number of cycles in which pressure is applied. For example, for some muscle groups, it may be found that applying pressure over lesser or greater time periods may be preferred . As best understood, the resonance frequencies are transmitted to the patient passively. For instance, the movement of the individual muscle or muscle group excites a frequency response from the carrier layer 12 and/or mineral matrix layer 14 of the device 10. In other embodiments, a delivery mechanism may be used to actively excite a frequency response from the device 10. Referring to Fig. 4A, a simplified flow diagram is provided for the basic steps in manufacturing the device 10. As shown, block 40 is the preparation of the muscle formula in which the formula is prepared by grinding and mixing the constituent components of the formula. At block 42, after the components have been mixed, the components are dissolved in an aqueous solution of alcohol. At step 44, a first quartz chamber is provided that contains the aqueous solution. At step 46, a ruby laser source is located adjacent the first quartz chamber. At step 48, a second quartz chamber is provided, and the second quartz chamber contains a buffered salt solution comprising selected salts, and a quartz crystal . The second quartz chamber is positioned on the opposite side of the first quartz chamber as compared to the position of the ruby laser source. At block 50, the laser is activated, and the laser beam first passes through the first quartz chamber into the second quartz chamber. The passing beam of the laser through the first quartz chamber results in excitation of the aqueous solution so that the frequency resonance characteristics of the muscle formula are transferred to the quartz crystal in the second quartz chamber. The transferred frequency resonance characteristics are retained in the quartz crystal in the form of a combined frequency resonance pattern transferred to the quartz crystal. The buffered salt solution stabilizes this frequency resonance pattern transferred to the quartz crystal. This method transfers into the quartz crystal/salt solution the combined frequency resonance pattern of each component of the muscle formula into a single frequency resonance matrix, the MF frequency resonance matrix. Thus, the quartz crystal-salt solution "programmed" with the MF frequency resonance matrix is the master crystal, and the master crystal has been shown to maintain this frequency resonance matrix over time. Block 52 signifies that the master crystal has been created with the embedded MF frequency resonance matrix, and then can be used in production for transferring the MF frequency resonance matrix to the individual chips/devices 10. At block 54, the ruby laser is arranged to transmit a pulse of light directed to pass through the master crystal onto each mdi viduai chip as they pass the tip of the master crystal at a controlled speed. Many types of computer/holographic chips are provided in rolls with individual chips being spaced from one another along the length of the roll. Th erefore, the ruby laser can be programmed to transmit its laser beam on each individual chip as it passes the location of the master crystal. At block 56, after each chip/device 10 has received the MF frequency resonance matrix, each chip then receives its corresponding transparent protective layer 16. In an alternative embodiment, the patient has a more active role in the steps at blocks 20, 22, 24 wherein the user performs a predetermined motion, Then, depending on the effort required to perform the predetermined motion, a muscle or tissue imbalance may be located. The device and other components described herein may be placed on the patient's navel or over the particular muscle or tissue imbalance for a predetermined time. In some embodiments, the predetermined time is between approximately 2 to 10 minutes. Next, the patient may re-perform the predetermined motion for the steps at blocks 30, 32, 34 to observe if more treatment is required. In various embodiments, multiple devices and associated components may be deployed on a patient to achieve the desired effect.

Data has been collected in a proof-of-concept study and an IRB-approved university trial assessing muscle function using the device and method of the invention. In initial clinical studies the invention has been shown to reliably produce consistent improvements in muscle function. One common measure of muscle function is termed Electromyography or EMG that measures the electrical activity of the individual motor units as they shorten during contraction. In EMG, the Electromyograph is attached to a recording electrode which is either a needle inserted into the muscle to record muscle activity, or to a transcutaneous electrode that records electrical activity of the muscle from the surface of the skin. In the university study, transcutaneous electrodes were used. When the muscle is attached to either needle or transcutaneous electrodes, muscle activity is measured by electrical frequencies sent to the Electromyograph, which can then convert these raw frequencies into several types of electromyograms (EMGs). One common type of electromyogram is called an Integrated Power Spectrum. This graphically presents the number of motor units actively contracting in the muscle over time and is measured in millivolts. The greater the number of motor units contracting at any one time indicates a stronger muscle contraction.

Fig. 4B is a flowchart for imprinting a device with a therapeutic resonant frequency pattern. First, a formula is prepared at step 41. In this embodiment, the formula is a nutraceutical formula that has resonant frequency pattern, which is a physical property of the nu traceutical formula. This formula may be a mixture of bioactive substances, and different formulas may target different physiological systems and conditions of a patient's body. For example, formulas may target muscle function (i.e., a muscle formula), tissue oxygenation (i.e., an oxygen formula), etc. Other formulas may target neurological function, nervous system function, the digestion system, the immune system, organ function, depression, inflammation, and other physiological systems and conditions. Formulas in some embodiments may be derived from nutraceuticals, pharmaceuticals, oxygen, and any combination thereof. Various bioactive substances that have a resonant frequency pattern may include biomolecules, cells, tissues, connective tissue, collagen (i.e. organs, bone marrow), plasma, hemoglobin, nucleic acids, DNA, RNA, enzymes, proteins, amino acids, peptides, polypeptides, carbohydrates, saccharides, lipids, signaling molecules, neurotransmitters, hormones, pheromones, immunogenic system substances, pathogens (i.e. Polio virus, malaria), nutrients, pharmaceuticals, biologies, and other biogenic substances.

At step 43, the nutraceutical formula is added to a solution, which in some embodiments is a water/ethanol mixture. If will be appreciated thai while the nutraceutical formula may be added to a fluid, the nutraceutical formula may also be utilized as a solid such as a powder. Next, at step 45, the nutraceutical solution is added to a chamber. In some embodiments, there is only a single chamber. However, in other embodiments, there are additional chambers, for example, two chambers, three chambers, etc. In a two chamber configuration, a second chamber may be at least partially disposed in the first chamber. The nutraceutical solution is located between the two chambers, and the second chamber creates a volume that is surrounded by the nutraceutical solution. A substrate or other target that is to be exposed to a wave may be placed in the second chamber.

The chamber, or chambers, may have a variety of characteristics to accommodate the process in Fig. 4B. The shape of the chamber may be any shape that defines a partially enclosed volume. For example, the chamber may have a circular cross section with an aperture at one end of the chamber configured to receive the nutraceutical formula. The chamber may also optionally comprise a lid to cover the aperture and fully enclose the volume. In some embodiments, the length, width, and height dimensions may each vary between approximately 2-50 cm. The material of the chamber may be electromagnetically transparent to allow electromagnetic waves to pass through the chamber and interact with the nutraceutical fomiula and the substrate. Examples of chamber materials include quartz, borosilicate glass, and inert plastics.

Next, at step 47, a pulsed electromagnetic frequency (PEMF) device is placed proximate to the chamber. The PEMF device generates an electromagnetic wave with a pulse frequency or frequencies between approximately 0.5 and 50 Hz. The peak amplitude of the magnetic field generated by the PEMF device may be less than 10000 Gauss, and in some embodiments, the PEMF device may not generate power above a frequency of 100 kHz. At step 49, a substrate is positioned at least partially within the chamber, and the substrate is positioned such that it is opposite the PEMF device. In other words, the nutraceutical formula is positioned between the substrate and the PEMF device. The solution of formula may be characterized by optical depth, which is a dimensionless parameter that is the natural logarithm of the ratio of incident to transmitted radiant power through a material . In various embodiments, the solution through which the wave passes through has an optical depth of between approximately 0.01 and 4.

In steps 51 and 53, the PEMF device is activated, and the formula and the substrate are exposed to the PEMF's electromagnetic wave. The period of the pulse may last between approximately 2 to 600 seconds to transfer the therapeutic resonant frequency pattern of the nutraceutical formula to the substrate. The resulting imprinted device may comprise only the substrate itself. However, it will be appreciated that in other

embodiments, the substrate may be optionally combined with other components as described elsewhere herein, such as a mineral matrix layer or a protective layer, to create an imprinted device.

While a PEMF device is used in Fig. 4B, other wave sources may be used to generate waves that pass through the chamber, the nutraceutical formula, and into the substrate. In one exemplary method, a sample of the aqueous alcohol / nutraceutical solution is placed into a Pyrex or quartz chamber. The sample might contain 5 - 1000 ml of the nutraceutical solution. One or more substrate targets is placed within a second Pyrex or quartz container, which is placed within the first chamber so that the nutraceutical solution surrounds the targets. Both chambers are placed within an apparatus capable of generating oscillating electromagnetic fields. The field generator is activated, and the targets are exposed for a period of time; the oscillating electromagnetic field serves as a carrier wave to transfer the resonant frequency pattern of the nutraceutical formula to the substrate target. The frequency or frequencies of the electromagnetic field can vary from low through radio and microwave frequencies and combinations thereof. The resonant frequency pattern has been shown to be retained or imprinted on the substrate.

In some embodiments, the wave source generates an electromagnetic wave having a frequency or frequenci es in the range of infrared light (300 GHz - 400 THz), visible light (400 THz - 770 THz), and/or ultraviolet light (770 THz - 30 PHz). The chamber or chambers used in these embodiments may have configurations and dimensions as discussed elsewhere herein, for example, the chamber has a portion that is optically transparent. The power of the wave source may be less than 100 W, and the period of time that the substrate is exposed to the wave may be between approximately 2 and 600 seconds. Other components may be utilized along the transmission path between the wave source and the chamber or chambers, including coliimating lens for narrowing the wave and diverging lenses for expanding the wave.

In another exemplary method, a sample of the aqueous alcohol / nutraceutical solution is placed into a quartz chamber. The sample migh t contain 5 - 1000 ml of the nutraceutical solution. The quartz chamber containing the nutraceutical solution is placed into an apparatus in which a continuous- wave or pulsed laser passes through a beam- expanding lens and the quartz chamber, to folly illuminate a target substrate. The laser is activated, and the target exposed for a period of time; the laser beam serves as a carrier wave to transfer the resonant frequency pattern of the nutraceutical formula to the substrate target. The resonant frequency pattern has been shown to be retained

("imprinted") on the substrate.

In further embodiments, the wave source generates an electromagnetic wave having a frequency or frequenci es in the range of radio waves (3 Hz - 300 M Hz) and/or microwaves (300 MHz - 300 GHz). A Gunn diode or an amplified signal generator may serve as the wave source. The peak power of the emitted waves may be less than 100W, and the length, width, and height of the chamber may each vary between approximately 2- 50 cm. The period of time that the substrate is exposed to the wave may be between approximately 2 and 600 seconds.

In yet further embodiments, the wave source generates an electromagnetic wave having a frequency or frequencies in the range of low-frequency waves (below 3 kHz). A signal generator with an optional amplifier may serve as the wave source. The peak power of the emitted waves may be less than 100W, and the length, width, and height of the chamber may each vary between approximately 2-50 cm. The period of time that the substrate is exposed to the wave may be between approximately 2 and 600 seconds.

In other embodiments, a magnetic source generates a magnetic field (i.e., wave) that passes through the chamber through the nutraceutical formula, and into the substrate. A first coil may be positioned at a first end of the chamber. A signal generator may supply power of less than 10 W into the first coil to directly expose the nutraceutical fommla and the substrate to a magnetic field. The first coi l may have a resistance of 50 Ohms. In further embodiments, a second coil is positioned at a second end of the chamber, and the first and second ends may be arranged opposite each other. A third coil is positioned at a base of a second chamber, and connected via an appropriate resistance to form an electrical circuit with the second coil, and the nutraceutical formula is placed in the first chamber. Supplying a signal and power to the first coil induces a response in the third coil that generates a magnetic fiel d. The length, width, and height of the chamber may each vary between approximately 2-50 cm, and the period of time that the substrate is exposed to the magnetic field may be between approximately 30 and 600 seconds.

In various embodiments, the wave source generates a mechanical wave such as an acoustic wave. An exemplary wave source may be a speaker with a strong frequency response below 200 Hz, and the chamber may be made from an acoustically-transparent material or have an acoustically-transparent section oriented toward the transmission path of the acoustic wave. The energy supplied to the speaker may be less than 100 W. The length, width, and height of the chamber may each vary between approximately 2-50 cm, and the period of time that the substrate is exposed to the magnetic field may be between approximately 2 and 600 seconds. Various waveforms may be used in conjunction with the embodiment described with respect to Fig. 4B. These waveforms include those described elsewhere herein. Various embodiments may further comprise a protective cover that contains the waves transmitted through a formula and into a substrate. The protective covers can be made from shapes and materials that allow the protective cover to function as a Faraday Cage.

A single device may be imprinted with one or more therapeutic resonant frequency patterns, and there are several systems and processes to imprint a device with the therapeutic resonant frequency patterns of multiple formulas. First, a device may be imprinted with therapeutic resonant frequency patterns serially. In one example, the device is subjected to a wave passing through a nutraceutical formula, and the device is imprinted with the therapeutic resonant frequency patterns associated with the nutraceutical formula. Then, the device is subjected to a wave passing through an oxygen formula, and the device is imprinted with the therapeutic resonant frequency patterns associated with the oxygen formula. Thus, the resulting device is imprinted with therapeutic resonant frequency patterns associated with both the nutraceutical formula and the oxygen formula.

Second, the device may be imprinted with therapeutic resonant frequency patterns simultaneously. This means that a composite formula may be formed from one or more constituent formulas. For example, a nutraceutical formula and an oxygen formula may be combined to form a composite formula. Then, a wave passing through the composite formula imprints therapeutic resonant frequency patterns on the device where the therapeutic resonant frequency patterns as associated with both the nutraceutical formula and the oxygen formula. The imprinting process in various embodiments may employ any wave generation processes discussed herein, including those associated with the subsequent excitation of the resonant frequency patterns from the substrate or imprinted device. In addition, the imprinting methods described with respect to Fig. 4 create a first generation device. A first generation device may be excited to imprint resonant frequency patterns onto another device. This second imprinted device is a second generation device. The process may be continued to create any number of generation devices.

Figs. 5 and 6 are graphical examples of muscle testing for two different muscles conducted in preliminary human pilot studies. In these examples, the subject's muscles became eccentrically contracted or "unlocked" when manually tested, and the muscles coul d only facilitate a small number of motor units when tested; accordingly the muscl es failed under only moderate pressure applied to the corresponding limbs of the muscles. In both examples the muscles were under-facilitated because not enough motor units could fire to fully facilitate the muscle and isometrically contract or "lock". As shown, the muscles tested were a middle deltoid muscle (Fig. 5) and a pectoralis major clavicular muscle (Fig. 6). The PreTest data (the PreTest referenced in the legends of the graphs of Figures 5 and 6) reflects the states of the muscles when initially evaluated.

In the Chip test (the Chip referenced in the legends of the graphs), the device 10 was applied to the navel, and the arm moved into the test position, where its fibers were aligned and shortened to provide maximal mechanical advantage during the test. With both muscles there was a dramatic increase in the number of motor units recruited (activated) by the pressure applied to the arm to isometrically contract or "lock" the muscle and hold it in place throughout the 5 to 6-second duration of the muscle test while the device 10 was applied to the navel. As shown in the test data, there w^ras a rapid increase in the EMG power spectra of both muscles as pressure was applied, then sustained full 5 to 6 seconds pressure was applied, and then the rapid return to baseline once the pressure had ceased.

The device 10 was removed from the navel, and after a 3 to 5 minute rest period, the muscle was tested once again, (this later test referenced as the Posttest in the legends of the graphs). As shown, both muscles recruited even a larger number of motor units than when the device 10 was being applied to navel. The Posttest data indicates that the muscles developed a full isometric contraction or "lock" signifying a "reset" of the proprioceptors that had been inhibiting these muscles before the treatment.

Referring to Fig. 7, this figure indicates that the effects from application of the device 10 in a treatment appear to be long-lasting. In this Figure, the y-axis represents a range of mobility and a pain scale in which 0 represents a state in which there is no mobility or no pain, and 10 represents a state in which there is full mobility or maximum pain. This figure reflects data obtained in a proof of concept study of a group of 13 individuals with chronic shoulder pain and muscle dysfunction who were treated only one time, yet this study group showed a greater than 77% increase in limb mobi lity (measured as a function of a mobility scale from 1-10). The study group also showed a nearly 62% reduction in pain ten weeks after treatment (measured as a function of a pain scale from 1 - 10). As indicated in the graph of Fig. 7, dark bars (left) represent patients that showed improvement for pain and mobility, while the lighter bars (right) represent those patients that did not show measurable or appreciable improvement. The graph of Fig. 7 clearly shows that patients did show improvement, particularly in mobility.

In summary, the device and method of the present invention are capable of producing rapid improvement in muscle dysfunction. The therapeutic benefits can be realized by evaluating a starting point in which a muscle is in a state of overt imbalance, and is transferred to a new state of homeostasis in less than five minutes. Many of these rapid corrections were evaluated as long-lasting.

The invention now being generally described will be more readily understood by reference to the following example, which is included merely for the purposes of illustration of certain aspects of the embodiments of the present invention. The example is not intended to limit the invention, as one of skill in the art would recognize from the above teachings and the following examples that other techniques and methods can satisfy the claims and can be employed without departing from the scope of the claimed invention.

EXAMPLES

This example provides an IRB-approved university study demonstrating the effect of a muscle optimization (MO) device of the present invention on the ability of the muscle to produce force and surface muscle energy activity. The muscle optimization device is postulated to improve muscle function by resetting muscle proprioception and improving muscle strength. Preliminary pilot studies using surface electromyography (EMG), described above, provided sufficient positive results to warrant a full-protocol study with human subjects using both EMG and a force gauge meter to test consistency and correlation.

The study is a Test-Retest design wherein the initial state of muscle imbalance was assessed with quantitative surface EMG. The muscle optimization device was applied over light clothing on the navel. The muscle with identified weakness was then activated, and force applied during testing the muscle was determined by a multi-directional force transducer, and the muscle response quantified using surface EMG. The results were analyzed for correlation between the objective force applied and the number of motor units recruited during each test. The major outcome measures are peak force generated and surface EMG curve produced during isometric or eccentric muscle contractions.

Study subjects were selected from healthy, active athletes participating in a variety of sports such as volleyball, tennis, racquetball, basketball, soccer, ice hockey, rock climbing, boxing, football, lacrosse or Nordic skiing. Participants were selected based on self-reports as being physically healthy, but who experienced muscle weakness in certain muscles/muscle groups, such as muscle imbalances of the shoulder joint: supraspinatus; middle deltoid; anterior deltoid; pectoralis major; clavicular division or latissimus dorsi. Study subjects were between the ages of 18 to 35, reportedly in good health, with no acute shoulder injury, inflammation or pain. Those subjects who reported a degenerative muscle condition or neurologic disease, such as multiple sclerosis, or asthma, were excluded from the study.

Inclusion Criteria for the test subjects: To address the inherent variability of muscle function, the study was limited to volunteer subjects who have an imbalance or weakness in one or more of the following, easily isolatable muscles of the shoulder joint.

1. supraspinatus

2. middle deltoid

3. anterior deltoid

4. pectoralis major, clavicular division

5. latissimus dorsi

These muscles have been selected upon the basis of being accessible to attach the surface EMG electrodes, and agonists that can be isolated with respect to muscle fiber alignment and have limited synergist activity until relatively higher force has been applied. These are also all muscles for which multiple-examiner reliability is high. Age: between the ages of 18 to 35

Sex: male or female Health Status: self-reported in good health, Sport: subjects will be active in a sport or training that may lead to over use or misuse of shoulder muscles, specifically: volleyball, tennis, racquetball, basketball, soccer, ice hockey, rock climbing, Nordic

skiing, martial arts, crew. Exclusion Criteria for the test subjects: Chronic illness or injury: Self-reported chronic shoulder problems; A degenerative muscle or neurologic disease such as Multiple Sclerosis or asthma: Previous injuries, including acute shoulder injury, including inflammation or pain: Neck, whiplash, or spinal column injury(s); Past Surgeries: A subject having undergone any past surgeries on arm, shoulder or neck.

Subjects read and completed an Informed Consent Form in addition to a verbal description of the experiment. Those subjects participating in the study underwent muscle testing to identify inhibited/ eak selected upper body muscles. Identification of muscle inhibition or weakness was assessed by placing the subject's arm in the test position and then asking the subject to "hold" against a pressure applied by the experimenter via the held-hand force transducer. The outcome of the test was scored on a qualitative +3 Scale and assigned a score of 1 , 2 or 3. The direction of the pressure applied by the experimenter (e.g. "hold" your arm up with the thumb turned downward, or "hold" your arm into your side, etc., will varied depending upon which muscle was being tested. Those subjects scoring a "3" on the muscle test were assigned to the control group, subjects scoring a "1" or a "2" were assigned to the experimental group. Surface EMG electrodes were placed on the surface of the skin over the inhibited/weak muscle (for the experimental group subject), and over a standard muscle for the control group, using standard electrode placement procedures. Replicate tests were carried out on each muscle selected for assessment in the following sequence:

1) Control Test: Assessment of the initial muscle imbalance for 6 seconds (3 trials);

2) MO Device Test: Assessment of the muscle response with the MO Device placed on

clothing above the navel and the muscle activated for 6 seconds (3 trials);

3) The Post-MO Device Test: Assessment of the muscle response following MO Chip therapy with no Chip on the body for 6 seconds (3 trials).

The amount of pressure was recorded using a hand-held force transducer applied by the experimenter and the EMG signal was recorded from the surface electrodes. Testing time for each subject is estimated to be no longer then one hour.

Testing Protocol and preparation of selected muscles for Surface

Electromyography (EMG): Muscles that have met the inclusion criteria (either a weak muscle or a control muscle) were prepared for surface EMG recording and attached to the EMG to insure a good signal to noise ratio. The BioNomadix™ wireless EMG system (BioPac Inc.) is used to collect the muscle activity data. First, the skin is cleaned using an alcohol pad and the electrodes (EL500, BioPac Inc) are affixed to the surface of the skin above the belly of the muscle of interest. The ground electrode is affixed to an area without muscle activity.

The force transducer (microFET2) is turned on using the on/off switch, and sensitivity

setting set to high. The data recording software, ErgoPak, is launched on the PC, and the meter linked via the blue tooth dongle with the software.

Muscle Test Position: The muscle(s) selected for monitoring are placed in their prescribed muscle testing position to reduce synergist(s) recruitment and to isolate the chosen muscle as much as possible as the Prime Mover or PM for that specific action. The arm is placed into the specific test position in maximal concentric contraction to align the muscle fibers of the Prime Mover, and reduce recruitment of its synergist(s). The subject is asked to "hold" their arm in this position and informed by the monitor exactly how and in which direction pressure will be applied. The subject is then asked to "hold" as the monitor begins to slowly apply increasing pressure in the test direction over approximately 2 seconds, and if the muscle isometrieally contracts or "locks" to maintain that pressure for 2 seconds, then slowly release the pressure applied over approximately 2 seconds. The pressure applied is an appropriate force for the muscle tested. With this appropriate force, a clear isometric contraction or "Lock", or eccentric contraction or "Unlock" is observed, and the results recorded. The test is repeated three times to obtain mean values for each muscle tested.

Muscle Optimization Device (MO) Procedure: Muscles that eccentrically contract or "unlocked" in the screening testing, and the control muscle were re-tested after a Muscle Optimization Chip was placed on top of clothing above subject's navel, and the triplicate testing repeated, as described above. Force - time record, surface EMG time record and peak force were recorded. Rating of muscle function (1, 2 or 3) by tester was recorded.

Muscle Optimization Device (MO) Re-Test Procedure: The MO was taken off and the muscle was re -tested in the triplicate testing procedure described above. Three to five minutes were given between the initial testing and the subsequent MO trials. Electrodes only remained affixed to the surface of a subject's skin for less than or equal to one hour in time.

A within-subject ANOVA was used to determine significant differences between conditions in terms of the maximum pressure exerted, the trial-to-trial variation in the pressure exerted, the mean peak EMG signal, and the root mean square of the EMG signal. The surface EMG results were presented graphically for each test condition, without the MO Device and with the MO Device on the navel.

Results: As shown in Figure 8, with results from n = 14 subjects tested in this Pilot

Study, a significant difference has been observed in change in peak force between experimental and control subjects (p<0.05). The "Chip Applied" data refers to a peak force when a therapeutic device is being applied to a patient, which is contrasted with a pre- treatment peak forces. The "Post 'Treatment'" data refers to a peak force measurement after the therapeutic device has been removed, which is contrasted with the peak force when a therapeutic device is being applied to a patient. Additionally, the threshold represents a meaningful change in force, based upon published literature. As shown in Figure 9, a significant difference was observed in the mean EMG Root Mean Square for the three test conditions between Chip Applied and Post "Treatment" for experimental Subjects (p<0.05). As shown in Figure 10, a reasonable linear relationship was observed for peak force and mean EMG Root Mean Square (RMS) for the three test conditions. Figure 11 provides an example of the relationship between the peak force and the mean EMG Root Mean Square (RMS) for the three test conditions in a single experimental subject, anterior deltoid muscle.

In other embodiments of the invention, the substrate or carrier layer 12 comprises a resonance frequency or resonance frequencies that are used in applications of the device 10. In these embodiments, the carrier layer 12 and its resonance frequency or frequencies may be utilized in tandem with the mineral matrix layer 14 and its resonance frequency or frequencies, or the carrier layer 12 may stand alone. In other words, the device 10 may optionally include the carrier layer 12 on the mineral matrix layer 14 along with a delivery mechanism to generate the therapeutic benefits of the invention.

The size and shape of a carrier layer 12 at least partially determines the resonance frequency of the carrier layer 12, and the range of frequencies that the carrier layer 12 is capable of generating. For example, when the carrier layer 12 is a crystal, the crystal may comprise a particular cut that influences the crystal's resonance frequency as well as how environmental qualities such as temperature, pressure, and humidity impact the

performance of the crystal. Examples of crystal cuts include, but are not limited to, AT, SC, BT, IT, FC, AK, CT, DT, SL, GT, E, 5°X, MT, ET, FT, NT, XY, H, J, RT, SBTC, TS, X 30°, LC, AC, BC, NLSC, Y, X, and combinations thereof. The material that the carrier layer 12 is made from also at least partially determines the resonance frequency of the carrier layer 12, and the range of frequencies that the carrier layer 12 is capable of generating. The carrier layer 12 may be comprised of a variety of materials including, but not limited to, piezoelectric crystal, quartz, silicon, plastic, glass, saline solution, mineral solution, synthetic crystal, sapphire, moissanite, natural crystal, gem stone, metal, ceramic, resin, viscous substance, lithium tantalate, lithium niobate, lithium borate, berlinite, gallium arsenide, lithium tetraborate, aluminium phosphate, bismuth germanium oxide, poly crystalline zirconium titanate ceramics, high- alumina ceramics, silicon-zinc oxide composite, dipotassium tartrate, gallium phosphate, langasite, langanite, langanate, leaded glass comprising 18 to 40 % lead oxide determined on a weight basis, and doped variants and/or combinations thereof.

In some embodiments of the present invention the carrier layer 12 is resonance inert, meaning the carrier layer 12 does not comprise a resonance frequency. These carrier layers 12 may simply provide a substrate for the mineral matrix layer 14. For example, a silicon wafer grown by the Czochralski method adds no characteristic resonance frequencies beyond its natural phonon frequencies.

Delivery mechanisms that excite frequency responses via sympathetic resonance utilize electromagnetic or mechanical waves.

Referring to Fig. 12A, a first device 10 and a second device 58 are provided without a delivery mechanism. In some embodiments, a delivery mechanism may be optionally included depending on a number of factors, including the patient's ailment. The delivery mechanism may activate, modulate, or amplify frequency resonance patterns among other actions. As described above, the contraction of the muscle alone may provide the excitement necessary to generate frequency responses from the substrate of the device 10 or carrier layer 12. The contraction of a muscle may be sufficient when the patient's ailment is a simple muscle strain or other imbalance. However, some patient's ailments prevent the contraction of a muscle or other bodily movement that excites the frequency resonance pattern imprinted in the substrate of the device or carrier layer 12. For example, muscular dystrophy or multiple sclerosis patients may not have a complete range of motion or muscle response to sufficiently excite the device 10. Therefore, the delivery mechanism provides excitation to the device 10 and the substrate or carrier layer 12 when there is no other excitation. It will be appreciated that a delivery mechanism may also be used on any patient to enhance or supplemental existing excitation.

The device's 10, 58 in Fig. 12A are stacked on top of each other and may comprise different materials. The first device 10 may comprise a substrate or carrier layer 12 with a first composition, and a second device 58 may comprise a substrate or carrier layer 12 with a second composition. For example, the substrate of the first device may be imprinted with a frequency resonance pattern of a muscle formula as discussed elsewhere herein, and the substrate of the second device may be imprinted with a frequency resonance pattern of an oxygen formula. In further embodiments, multiple compositions, carrier layers 12, or substrates may be combined into a single device 10.

Mechanical waves include acoustic waves generated by devices such as a piezoelectric transducer and other similar devices. In some embodiments, an acoustic resonator such as a tuning fork may have a frequency range between approximately 62 Hz and 4111 Hz, wherein the tuning fork may excite a resonance frequency in a layer. Other delivery mechanisms may produce ultrasonic waves, which are acoustic waves above the range of normal human hearing. Delivery mechanisms 60 that generate mechanical waves may comprise a frequency generator to control the wave frequency or frequencies, wave form, and wave amplitude among other attributes of the mechanical wave. In a specific example, a FG085 MiniDDS Function Generator is connected to a sheet or membrane with alligator clips or other means of operative connection. The membrane in this embodiment has piezoelectric properties, meaning electric charge accumulates in response to mechanical stress, or vice versa. A particular frequency or frequencies, wave form, and amplitude may be applied to the membrane to alter the properties of the membrane, for example, to match the signal of nutraceuticals or other bodily components. After an embedding step, the membrane may be used as the substrate or carrier layer 12 or may be added in combination with any layer of the device 10.

Referring to Fig. 12B, a first device 10 and a second device 58 are provided with a delivery mechanism 60. In the realm of electromagnetism, the source of an

electromagnetic wave may come from a variety of electromagnetic delivery mechanisms 60. For example, frequency generators, Pulsed Electromagnetic Fields ("PEMF"), Transcutaneous Electrical Nerve Stimulation ("TENS"), LASERs, and other similar devices can be used as a delivery mechanism 60 to excite a frequency response in the device 10. As shown in Fig. 12B, a delivery mechanism 60 may comprise a cable 62 that extends from a main body or housing of the delivery mechanism 60. The cable 62 transmits an electromagnetic wave to the devices 10, 58 and/or the patient. It will be appreciated that a plurality of cables 62 may be employed, including cables 62 that connect to the delivery mechanism 60 at a single location, not two locations as shown in Fig. 12B. Similarly, a plurality of delivery mechanisms 60 may be employed.

The cable 62 may be positioned in a particular arrangement relative to the devices 10, 58. For example, the cable 62 may be arranged in a coil shape around the devices 10, 58 when the devices 10, 58 are placed over or in proximity to the tissue to be treated. To preserve this arrangement, the cable 62 and the devices 10, 58 may be placed into a housing 70 defining a partially enclosed volume such as a pocket. Then the housing 70 is placed over or proximate to a patient's tissue or muscle for therapeutic treatment.

In some embodiments, the delivery mechanism's 60 cable 62 is arranged around the outer perimeter of the one or more devices 10, 58 to maximize the contact area between the cable 62 and the devices 10, 58. In various embodiments, the cable 62 is arranged in a coil having a diameter between approximately 2" and 10". In some embodiments, the cable 62 is arranged in a coil having a diameter between approximately 4" and 7". In one embodiment, the cable 62 is arranged in a coil having a diameter of approximately 5.5". The number of turns the cable 62 makes upon itself may be any number of turns, including one, two, three, four, five, etc. The thickness of the cable 62 in some embodiments may be between approximately 0.5" to 2" thick.

In other embodiments, the cable 62 may be arranged in a coil have a diameter that is less than one or more devices 10, 58. In these embodiments, the cable 62 may rest on top of the electrodes 62, 64, or the cable 62 may be positioned between devices 10, 58. In yet other embodiments, the cable 62 is arranged in a coil have a diameter that is greater than the one or more devices 10, 58, which creates a space. In some embodiments, this space may be between approximately 0.1" and 2". In various embodiments, this space may be between approximately 0.25" and 1".

Referring to Figs. 13A and 13B, a single device 10 may be utilized with or without a delivery mechanism 60 as described in Figs. 12A and 12B, respectively. As described elsewhere herein, a single device 10 may be imprinted with a therapeutic resonant frequency pattern associated with a single formula such as a nutraceutical formula. In other embodiments, the device 10 may be imprinted with more than one therapeutic resonant frequency patterns associated with more than one formula. In some embodiments, the device 10 is imprinted with therapeutic resonant frequency patterns associated with both a nutraceutical formula and an oxygen formula. These multiple therapeutic resonant frequency patterns may be imprinted serially or simultaneously. PEMF devices emit pulsations of electromagnetic radiation. The pulse wave or rectangular wave form is the preferred wave form associated with PEMF delivery mechanisms. However, PEMF delivery mechanisms may also utilize sine waves, square waves, triangle waves, saw-tooth waves, and any other waveform commonly known in the art, or waveforms of arbitrary shape constructed to efficiently convey therapeutic resonant frequency patterns to affected tissue. Other important parameters associated with the PEMF delivery mechanism include the frequency or frequencies of the electromagnetic radiation and the amplitude of the electromagnetic radiation, wherein the parameters are independently adjustable. PEMF delivery mechanisms used in combination with devices 10 described elsewhere herein can be used to treat pain, including chronic pain. Further literature regarding the benefits of PEMF treatment may be found in Rheumatol Int (2010) 30:571-586; Alternative

Therapies, July/Aug (2003), Vol. 9 No. 4, 38-48; and Cell Biochem Biophys (2013) 67: 1229-1237, which are incorporated herein in their entirety by reference.

For the PEMF delivery mechanism and other delivery mechanisms that utilize electromagnetic radiation, a variety of frequencies may be utilized. For example, radio waves (3 Hz - 300 MHz), microwaves (300 MHz - 300 GHz), infrared light or waves (300 GHz - 400 THz), visible light (400 THz - 770 THz), ultraviolet light (770 THz - 30 PHz), X-rays (30 PHz - 30 EHz), gamma rays (more than 30 EHz), and low-frequency waves (below 3 kHz) are all frequencies that the electromagnetic delivery mechanisms may utilize. Typically, lower frequencies are preferred in the utilization of PEMF devices as a delivery mechanism. In some embodiments, the PEMF delivery mechanism produces a frequency or frequencies less than approximately 3,000 Hz. In further embodiments, the PEMF delivery mechanism produces a frequency or frequencies less than approximately 100 Hz. In yet further embodiments, the PEMF delivery mechanism produces a frequency or frequencies less than approximately 24 Hz.

In one embodiment, a substrate or carrier layer 12 and/or a mineral matrix layer 14 may be imprinted with frequencies that correspond with the natural resonance of oxygen molecules or other oxygen substances, which typically ranges between 57 and 64 GHz. Further, the carrier layer 12 and/or mineral matrix layer 14 may be excited with these frequencies. An oxygen- specific carrier layer 12 or mineral matrix layer may be used alone or in combination with other layers described elsewhere herein.

Further, a frequency sweeping option may be utilized with electromagnetic delivery mechanisms. In one embodiment, the frequency sweep occurs between a first and a second reference frequency over a period of time. In some embodiments, the reference frequencies are approximately 0.5 Hz and 32 kHz. Reference frequencies may also include Schumann resonances (7.83 Hz and harmonics thereof, including 14.3, 20.8, 27.3, and 33.8 Hz). Further, reference frequencies can include any frequency of the electromagnetic spectrum. The frequency sweep occurs over time, but the sweep is not necessarily a continuous sweep between two reference frequencies. For example, a delivery mechanism may emit a first reference frequency for a first time period, and second reference frequency for a second time period, a third reference frequency for a second time period, and so on. One skilled in the art will appreciate various combinations of references frequencies and time periods to implement a frequency sweep option for a delivery mechanism.

One particular example of a PEMF is a device which pulses current to produce a pulsed electric field. This is significant because the coil applicator can be turned to provide predominately positive or predominately negative fields to the body. Using approximately 160 volts, it is possible to pulse electromagnetic waves with a frequency or frequencies less than 20 kHz and a lower magnetic strength limit of 10,000 Gauss. In some

embodiments, the voltages for the PEMF device may range between approximately 120 to 240 Volts. In various embodiments, the electromagnetic waves may be as low as 100

MHz. Further, in certain embodiments, the magnetic strength of the PEMF device may be between approximately 1 to 30,000 Gauss. Further yet, in some embodiments, the magnetic strength of the PEMF devices may be between approximately 2,400 to 21,000 Gauss.

PEMF delivery mechanisms and other delivery mechanisms may be used with one or more devices according to treatment protocols discussed elsewhere herein. For example, referring to the protocol discuss in Fig. 3, if there is an observed, isometric contracting or "unlocking", then at block 28, the device is placed on the central vessel 8 (the navel), or in other embodiments, the device is placed over or in proximity to the particular tissue or muscle along with a delivery mechanism. The various parameters of the PEMF delivery mechanism may be adjusted for a particular patient and/or a particular ailment. For example, autoimmune issues may require lower amplitude and higher frequency electromagnetic waves while neurological issues may require higher amplitude and lower frequency electromagnetic waves. Then, the protocol proceeds like the protocol in Fig. 3 and then at step 36 the device and delivery mechanism are removed from the patient.

Next, TENS delivery mechanisms utilize an electric current for nerve stimulation. TENS devices may modulate the pulse width, frequencies, amplitude, wave form, etc. of electromagnetic waves. Generally TENS is applied at high frequency (>50 Hz) with an intensity below motor contraction (sensory intensity) or low frequency (<10 Hz) with an intensity that produces motor contraction. Typically, the TENS devices includes one or more electrodes to deliver the electromagnetic wave. Dermal patches may be incorporated to adhere the electrode to a portion of a user's skin such that electrode is fixed relative to a muscle or muscle group. One skilled in the art will appreciate that a patch or other similar device may be used with other delivery mechanisms such as the PEMF device to secure the delivery mechanism relative to the muscle or muscle group.

In one particular example of the present invention, the carrier layer 12 is a quartz crystal with a particular size and cut. A quartz crystal has piezoelectric properties wherein an electric field distorts the physical shape of the quartz crystal. When the electric field is altered the quartz crystal changes shape and generates an electric field of its own. The rate of expansion and contraction of the quartz crystal can be the resonance frequency or resonance frequencies of the carrier layer 12. In other embodiments, fused silica, which is a non-crystalline form of silicon dioxide, may be used in combination with quartz or substituted in place of quartz.

In some embodiments of the present invention, the portion of the device 10, a carrier layer 12 and/or a mineral matrix layer 14, that comprises a resonance frequency may be heated or cooled to affect the performance of the layer 12, 14. In one embodiment, the carrier layer 12 comprises a resonance frequency. The carrier layer 12 may be heated or cooled when the carrier 12 is placed in proximity to the muscle or muscle group, and the delivery mechanism is placed in proximity to the carrier layer 12. Depending on attributes of the carrier layer 12 such as the cut, the change in temperature can affect the frequencies generated by the excitation of the carrier layer 12, and the change in temperature can directly enhance the therapeutic on the user.

Although the present disclosure describes components and functions implemented in the aspects, embodiments, and/or configurations with reference to particular standards and protocols, the aspects, embodiments, and/or configurations are not limited to such standards and protocols. Other similar standards and protocols not mentioned herein are in existence and are considered to be included in the present disclosure.

The present disclosure, in various aspects, embodiments, and/or configurations, includes components, methods, processes, systems and/or apparatus substantially as depicted and described herein, including various aspects, embodiments, configurations embodiments, sub-combinations, and/or subsets thereof. Those of skill in the art will understand how to make and use the disclosed aspects, embodiments, and/or configurations after understanding the present disclosure. The present disclosure, in various aspects, embodiments, and/or configurations, includes providing devices and processes in the absence of items not depicted and/or described herein or in various aspects, embodiments, and/or configurations hereof, including in the absence of such items as may have been used in previous devices or processes, e.g., for improving performance, achieving ease and\or reducing cost of implementation.

The foregoing discussion has been presented for purposes of illustration and description. The foregoing is not intended to limit the disclosure to the form or forms disclosed herein. In the foregoing Detailed Description for example, various features of the disclosure are grouped together in one or more aspects, embodiments, and/or configurations for the purpose of streamlining the disclosure. The features of the aspects, embodiments, and/or configurations of the disclosure may be combined in alternate aspects, embodiments, and/or configurations other than those discussed above. This method of disclosure is not to be interpreted as reflecting an intention that the claims require more features than are expressly recited in each claim. Rather, as the following claims reflect, inventive aspects lie in less than all features of a single foregoing disclosed aspect, embodiment, and/or configuration. Thus, the following claims are hereby incorporated into this Detailed Description, with each claim standing on its own as a separate preferred embodiment of the disclosure.

Moreover, though the description has included description of one or more aspects, embodiments, and/or configurations and certain variations and modifications, other variations, combinations, and modifications are within the scope of the disclosure, e.g., as may be within the skill and knowledge of those in the art, after understanding the present disclosure. It is intended to obtain rights which include alternative aspects, embodiments, and/or configurations to the extent permitted, including alternate, interchangeable and/or equivalent structures, functions, ranges or steps to those claimed, whether or not such alternate, interchangeable and/or equivalent structures, functions, ranges or steps are disclosed herein, and without intending to publicly dedicate any patentable subject matter.

Claims

What is claimed is:

1. A method for imprinting a device with a resonant frequency pattern, said method comprising:

providing a formula in a first chamber, the formula comprising a resonant frequency pattern;

providing a substrate, the substrate positioned proximate to the first chamber; providing a wave source positioned proximate to the first chamber and positioned opposite the substrate;

generating, by the wave source, a wave that passes through the first chamber, passes through the formula in the first chamber, and passes into the substrate, wherein the wave is generated for an exposure period; and

transferring the resonant frequency pattern of the formula to the substrate to create an imprinted device.

2. The method, as claimed in claim 1, further comprising:

providing the substrate in a second chamber, which is at least partially positioned in the formula in the first chamber.

3. The method, as claimed in claim 1, wherein:

the formula is a composite formula that comprises a first formula having a first resonant frequency pattern and a second formula having a second resonant frequency pattern.

4. The method, as claimed in claim 3, wherein:

the first formula is a nutraceutical formula, and the second formula is an oxygen formula.

5. The method, as claimed in claim 1, wherein:

the wave passes through a transmission surface of the first chamber, wherein the transmission surface is transparent to the effects of the wave.

6. The method, as claimed in claim 1, wherein:

the wave is an electromagnetic wave having frequencies corresponding to at least one of infrared waves, visible light, and ultraviolet light; and

the exposure period is between approximately 2 and 600 seconds.

7. The method, as claimed in claim 1, wherein:

the wave is an electromagnetic wave having frequencies corresponding to one of radio waves and microwaves; and the exposure period is between approximately 2 and 600 seconds.

8. The method, as claimed in claim 1, wherein:

the wave is an electromagnetic wave having frequencies corresponding to low- frequency waves; and

the exposure period is between approximately 2 and 600 seconds.

9. The method, as claimed in claim 1, wherein:

the wave source is a pulsed electromagnetic field generator having a pulse rate between approximately 0.5 and 50 Hz; and

the wave passes into the substrate for an exposure period between approximately 2 and 600 seconds.

10. The method, as claimed in claim 9, wherein:

the pulsed electromagnetic field has a magnetic flux density of less than 10,000

Gauss.

11. The method, as claimed in claim 2, further comprising:

providing a first coil of the wave source at a first end of the first chamber;

providing a second coil of the wave source at a second end of the first chamber, wherein the second end is positioned opposite the first end of the first chamber;

providing a third coil at an end of the second chamber, the third coil forming an electrical circuit with the second coil;

inducing a magnetic field in the third coil when the wave is emitted through the first coil.

12. The method, as claimed in claim 1, wherein:

the wave is an acoustic wave having frequencies less than 40,000 Hz; and the exposure period is between approximately 2 and 600 seconds.

13. The method, as claimed in claim 1, further comprising:

providing a second formula in a first chamber, the second formula comprising a second resonant frequency pattern;

providing the imprinted device proximate to the first chamber;

providing a wave source positioned proximate to the first chamber and positioned opposite the imprinted device;

generating, by the wave source, a wave that passes through the first chamber, passes through the second formula in the first chamber, and passes into the imprinted device; transferring the second resonant frequency pattern of the second formula to the imprinted device.

14. A system for imprinting a device with a resonant frequency pattern, said system comprising:

a first chamber having a first formula, the first formula comprising a resonant frequency pattern;

a substrate positioned proximate to the first chamber;

a wave source positioned proximate to the first chamber and positioned opposite the substrate;

a wave source configured to generate a wave that passes through the first chamber, passes through the formula in the first chamber, and passes into the substrate to transfer the resonant frequency pattern of the formula to the substrate to create an imprinted device.

15. The system, as claimed in claim 14, further comprising:

a second chamber, wherein the substrate is positioned in the second chamber which is at least partially positioned in the formula in the first chamber.

16. The system, as claimed in claim 14, wherein:

the formula is a composite formula that comprises a nutraceutical formula having a first resonant frequency pattern and an oxygen formula having a second resonant frequency pattern.

17. The system, as claimed in claim 14, further comprising:

a transmission surface of the first chamber, wherein the transmission surface is optically transparent.

18. The system, as claimed in claim 14, wherein:

the wave is an electromagnetic wave having a frequency corresponding to at least one of low- frequency waves, radio waves, microwaves, infrared waves, visible light, and ultraviolet light.

19. The system, as claimed in claim 14, wherein:

the wave source is a pulsed electromagnetic field generator having a pulse rate between approximately 0.5 and 50 Hz;

the pulsed electromagnetic field generator having a magnetic flux density of less than 10,000 Gauss.

20. The system, as claimed in claim 15, further comprising:

a first coil of the wave source positioned at a first end of the first chamber; a second coil of the wave source positioned at a second end of the first chamber, wherein the second end is positioned opposite the first end of the first chamber;

a third coil positioned at an end of the second chamber, the third coil forming an electrical circuit with the second coil, wherein a magnetic field is induced in the third coil when the wave is emitted through one of the first coil.

21. The system, as claimed in claim 14, wherein:

the wave is an acoustic wave having frequencies less than 40,000 Hz.

22. The system, as claimed in claim 14, further comprising:

a second formula in the first chamber, wherein second formula has a second resonant frequency pattern, and the wave passes through the first chamber, passes through the second formula in the first chamber, and passes into the imprinted device to infuse the second resonant frequency pattern of the second formula to the imprinted device.

23. A method for treating a biological tissue with an imprinted device, said method comprising:

generating, by a wave source, a first wave that passes through a formula in a first chamber, wherein the formula has a therapeutic resonant frequency pattern, and the first wave passes into a substrate to transfer the resonant frequency pattern of the formula to the substrate to create an imprinted device;

placing the imprinted device in proximity to a biological tissue;

providing a delivery mechanism in proximity to the imprinted device;

emitting, by the delivery mechanism, a second wave to excite the resonant frequency pattern of the imprinted device and to provide a therapeutic benefit to the biological tissue; and

removing the imprinted device from the biological tissue.

24. The method, as claimed in claim 23, wherein:

25. The method, as claimed in claim 23, wherein:

the first wave is an electromagnetic wave having frequencies corresponding to one of low- frequency waves, radio waves, microwaves, infrared waves, visible light, and ultraviolet light.

26. A method, as claimed in claim 23, wherein:

the second wave comprises at least one of a mechanical wave and an

electromagnetic wave.

27. A method, as claimed in claim 23, wherein:

the second wave comprises a waveform, wherein the waveform is at least partially comprised of at least one of a sine wave, a square wave, a triangle wave, and a saw-tooth wave.

28. The system, as claimed in claim 23, further comprising:

providing a second chamber, wherein the substrate is positioned in the second chamber which is at least partially positioned in the formula in the first chamber.

29. The method, as claimed in claim 28, further comprising:

providing a first coil of the wave source at a first end of the first chamber;

inducing a magnetic field in the third coil when the first wave is emitted through the first coil.

30. The system, as claimed in claim 23, further comprising:

a second formula in the first chamber, wherein second formula has a second resonant frequency pattern, and the first wave passes through the first chamber, passes through the second formula in the first chamber, and passes into the imprinted device to transfer the second resonant frequency pattern of the second formula to the imprinted device.

31. The method, as claimed in claim 23, wherein:

the delivery mechanism is a pulsed electromagnetic field generator.

32. The method, as claimed in claim 31 , wherein:

the pulsed electromagnetic field generator emits the second wave having frequencies below 100 Hz.