OrthoCor PEMF Device

OrthoCor Pulsed Resonance (PEMF) and Heat Therapy (PRHT)

The OrthoCor Knee System Basic is indicated for adjunctive use in the palliative treatment of post-operative pain and edema in superficial soft tissue and for pains, strains and arthritis of the knee.

The OrthoCor Active Therapy Systems use a specialized Pulsed Electromagnetic Field (PEMF) to relieve pain and reduce edema through safe, clinically proven and FDA-approved therapy. The PEMF signal is a low-level, time-varying electromagnetic field that penetrates superficial soft tissue, helping to accelerate the body’s natural anti-inflammatory and recovery responses.

To learn about using the OrthoCor before and after knee surgery, please click here.

Inside every Active System is the OrthoCor, a powerful microchip that delivers PEMF directly to the source of injuries. PEMF has been shown to stimulate reaction pathways that result in pain and inflammation reduction.

The OrthoCor Active System provides:

• noninvasive delivery of patented Pulsed Resonance Therapy (PRT)
• specialized PEMF technology reduces swelling and increases circulation to help relieve and manage pain
• completely drug-free pain relief
• rechargable battery-operation
• flexibility and freedom of movement during treatment

The following conditions have been successfully treated using PRT:

• arthritis
• knee swelling
• acute and chronic knee pain

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To purchase the OrthoCor device, please visit our store…

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The OrthoCor Active System at this time only offers a knee treatment system. The plans are to expand the number of systems to include treatments of the ankle, back, elbow and wrist.

The OrthoCor system is a portable, non-invasive device for providing therapeutic treatment to a joint to promote healing of the joint. It includes a cuff that is can be positioned around a joint. The cuff includes an electromagnetic stimulator configured to provide an electromagnetic field within the joint and a single-use heating element to provide temperature-based therapy to the joint.

It has a signal generator configured to generate pulsed electromagnetic signals within the joint along with temperature-based therapy to the joint. This is a unique feature of the OrthoCor system – PEMF and heat simultaneously.

The OrthoCor device is a portable, non-invasive device comprised of a multiple usage cuff and two single-use therapy units is designed to provide Electro-Magnetic Thermal Therapy (EMT²) for treating knee osteoarthritis. The EMT² provides both transcutaneous pulsed electromagnetic field stimulation and thermal therapy. The EMT² is designed to alleviate pain and increase range of motion without requiring direct skin contact to the afflicted joint. The single-use therapy units offer heat and PEMF stimulation when inserted into the cuff, which provides the power and control for the coils. The cuff is rechargeable and delivers a recommended amount of therapeutic charge. The cuff is fastened around the knee to direct the therapy to the inside and outside areas of the joint. The cuff is designed to be able to be worn during daily activities either over or underneath clothing.

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Technical aspects of the OrthoCor device

The average power input is less than about 300 mW during exposure. The device has two power sources–one to supply power to the signal generator and another to supply power to create the thermal exchange. The frequency generated is a 21.7 MHz carrier frequency; 2 msec burst duration (e.g., 2 msec burst on, and 498 msec burst off); 2 Hz burst frequency.

Thus, the OrthoCor Electro-Magnetic Thermal Therapy (EMT²) device is designed with a powerful electromagnetic stimulator created for the purpose of stimulating nerve, muscle, and/or other body tissues. Previous clinical studies have shown a high correlation between low-frequency PEMF and new cartilage growth for treating osteoarthritis. The OrthoCor device is easy-to-use and portable system that may have applications within a host of clinical and home health applications.

Heat is a natural remedy that may be used to both relieve pain and reduce discomfort. This is accomplished by stimulating the patient’s own temperature receptors which, in turn, aid in blocking the pain sensation from reaching the brain by relaxing deep muscles to reduce tenderness and pain. In order to attain a therapeutic heat transfer effect including increases in tissue temperature, blood flow, muscle lengthening, and metabolism, an intramuscular temperature of about 104 degrees F. (40 degrees Celsius) must be reached.

Numerous types of heat sources may be utilized to provide beneficial heat therapy in accordance with various implementations. For example, first and second thermal exchange components may be multi-use cartridges that require the patient to `re-heat` the cartridges before every use, such as by placing the cartridges in the microwave. Alternatively, first and second thermal exchange components may be one-time use cartridges that are designed to provide an irreversible exothermic reaction to provide a source of heat for a specified amount of time. In one embodiment, first and second thermal exchange components are cartridges that contain iron, carbon, sodium chloride, sodium thiosulfate, and water. When the CLLHW compound is exposed to air, it undergoes an exothermic reaction that produces heat. In other embodiments, heat may be provided through: a resistive based heating source; selective insulation; or “warmth” radiated from the battery during operation. As will be appreciated by one skilled in the art, first and second thermal exchange components may be heat sources designed such that they deliver heat therapy for any designated period of time ranging from a few minutes to the entire day. This designated period may or may not coincide with the electromagnetic field duration. In addition, first and second thermal exchange components may be pulsed such that the heat therapy is not constant.

The power source is a lithium-polymer, rechargeable battery.

It has a two coil arrangement with one coil on either side of the knee for generating the PEMF therapy. A voltage regulator is used to provide a constant supply voltage to the PEMF signal generator. A microcontroller triggers both coils, thereby generating accurate pulses at the pre-defined frequency. The triggering frequency is defined as the rate at which a set number of pulses occur. The switching frequency is the fundamental frequency of the individual pulses. Another parameter called the switching duty cycle is defined as the ratio of the pulse width over the switching period. The voltage of the pulses is equivalent to the strength of the PEMF therapy.

The required penetration depth of the PEMF generated by the signal generator will vary depending upon, for example, the size of the patient’s knee area. However, for an adult patient, the penetration depth is generally in the range of about 2 to 4 cm.

The magnetic field strength, “B”, applied to the body ranges from about 20 μT to about 100 μT.

The two-coil configuration uses about 20 times less power than a single-coil configuration because it requires a significantly smaller amount of energy to penetrate both sides of the knee.

The therapy is typically applied for up to 2 hours. The heating elements cannot be turned on and off, and so once activated they produce heat until they are exhausted.

It is designed such that it may be worn during normal daily activities without discomfort.

Even though it is approved for treatment of the knee joint, like any other PMFs it can be used to treat any joint or any other body part that might benefit from treatment with PEMF and thermal exchange. PEMF treatments can be carried out without the heating component, by simply plugging in the exhausted heating pods into their docking ports.

The stimulation device includes 2 disposable, single-use, air activated heating pods. The two pods are snapped into the docking ports or holders on both sides of the knee cuff. Therapy is only initiated once both parts are talked. When any pod is removed therapy is stopped.

PEMF therapy can occur through dressings, clothing, casts, compression garments, supports, or one or more other barrier between the knee cuff and the target tissue. The pods activate a switch that enables or turns on the heat and PEMF therapy.

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How the OrthoCor works for the approved indications

Osteoarthritis, also known as degenerative joint disease, is characterized by gradual loss of hyaline cartilage and, in extreme cases, cyst formation in and deformation of the subchondral bone. The hyaline cartilage lines the articular surfaces of the knee and provides cushion and lubrication for the joint. During osteoarthritis, the extra-cellular matrix of the cartilage is worn down at a greater rate than it is being synthesized, leading to a net reduction in the overall amount of cartilage at the articular surfaces of the knee. As the cartilage breaks down, symptoms such as pain, swelling, tenderness, stiffness, and eventual muscle atrophy are manifested. Chondrocytes, the cellular component of hyaline cartilage that is responsible for matrix synthesis and turnover, are also depleted, thus resulting in an inability to naturally recover from this disease. Additionally, cells present in osteoarthritic joints release catabolic cytokines and enzymes that suppress collagen synthesis.

To date, conventional therapies for osteoarthritis have aimed at reducing pain and the progression of joint damage in order to minimize disability and maximize quality of life. The current algorithm for the management of osteoarthritis includes diagnosing the disease, modifying patient activity, prescribing anti-inflammatory medications, injecting steroids into the knee, and as a last resort, surgery. Although this regimen does provide some benefit, it is by no means a cure all for patients with osteoarthritis.

Aside from the conventional therapies, there are currently a number of alternative therapies that may be used to treat osteoarthritis. Three of the forerunners in the non-invasive alternative therapy field include electric, static magnetic, and electromagnetic stimulation.

Electrical stimulation, such as transcutaneous electrical nerve stimulation (TENS), delivers mild electrical impulses across the skin and into regional nerves. In patients having osteoarthritis, pain impulses are transmitted to the spinal cord through small cutaneous fibers. TENS acts to stimulate large cutaneous fibers that subsequently transmit a faster impulse via C-fibers to inhibit pain signals from the small fibers. It is in this way that TENS masks the pain normally experienced by patients having osteoarthritis. It is also thought that TENS incites the secretion of endogenous opiates, the body’s natural pain killers, further reducing the pain experienced by patients with osteoarthritis.

Static magnetic stimulation has also been shown to provide medically relevant benefits. Various experiments designed to induce osteoporosis, fracture, and synovitis in animals have demonstrated faster bone repair, increased bone density, and decreased joint inflammation following magnetic treatments. It is thought that magnets can affect biological processes by: decreasing the firing rate of chronic pain neurons; modifying the rate of enzyme-mediated reactions; modulating intracellular signaling by affecting the functioning of calcium channels in the cell membranes; and enhancing blood flow. All of the above may provide some therapeutic benefit with respect to the symptoms of osteoarthritis.

Additionally, electromagnetic stimulation, a modality that generates a magnetic field by sending current through a coil, may also provide medical benefits for the treatment of osteoarthritis. It has been observed that physical stress on bone causes the appearance of tiny electric currents (piezoelectric potentials) that are thought to promote bone formation. In particular, studies of electrical phenomena in cartilage have demonstrated a mechanical-electrical mechanism resembling those described in bone, appearing when cartilage is compressed by the pressures generated through normal joint activity. Generating currents within cartilage is thought to stimulate cartilage cell activity, thus promoting the production of cartilage. New cartilage degeneration may work to combat the degeneration seen in osteoarthritis and therefore alleviate the symptoms of osteoarthritis.

The basic principle behind the concept of electromagnetic stimulation is that passing an electric current through a coil winding structure will generate an electromagnetic field. The electromagnetic field can, in turn, generate a current in any conductive material, such as nerves or other body tissues, within this field. The electromagnetically induced electric field created by properly oriented pulsed electromagnetic stimulation thus accomplishes the result of transferring charge to cells of the body. This induced current can lead to nerve firing, muscle contraction, stimulation of cell signaling pathways causing cell growth, and a number of other effects. In contrast to applications of electrical stimulation, pulsed electromagnetic stimulation does not require direct skin contact to induce nerve excitation. As a result, significantly higher levels of directed stimulation can be achieved through pulsed electromagnetic stimulation without the adverse effects of other technologies.

Pulsed electromagnetic fields generate small, induced currents (Faraday currents) in the highly conductive extracellular fluid, which thereby mimics normal internally generated electrical currents. These natural electrical currents are due primarily to movement of fluid containing electrolytes in channels of the bone containing organic material with fixed negative charges, generating what are called “streaming potentials.” Studies of electrical phenomena in cartilage have demonstrated a mechanical-electrical mechanism that resembles those described in bone, appearing when cartilage is mechanically compressed, causing movement of fluid and electrolytes over the surface of fixed negative charges in the proteins and collagen in cartilage. These mechanically generated electrical-type streaming potentials serve a purpose in cartilage similar to that in bone, and, along with mechanical strain, lead to signal changes that are capable of stimulating cartilage cell synthesis of matrix components.

In contrast to direct currents, PEMFs are able to penetrate all cell membranes and tissues in their path and either stimulate them or directly affect intracellular components. As a result, the effect of PEMFs on extracellular matrices includes increased production of cartilage molecules, thereby enabling a “remodeling” of the knee joint.

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OrthoCor Active Knee System Reference Guide

 

Indications for use

• · The OrthoCor Active Knee System is indicated for adjunctive use in the palliative treatment of post-operative pain and edema in superficial soft tissue.
• · Temporarily relieves minor muscle and joint aches and pain associated with overexertion, strains, sprains, and arthritis.

Contraindications

• · Do not use on patients with a cardiac pacemaker, cardioverter defibrillator, neurostimulator, infusion pump or any active medical implant.
• · Do not use on patients who have ANY implanted metallic lead or any type of wire coil implant, or any implanted system that may contain a lead.
• · Do not use on patients who are or may be pregnant.
• · Do not use on patients with an open wound at the area of application.
• · Do not use on patients not fully aware to the sensation of heat.
• · Do not use on patients with poor circulation or heart disease.
• · Do not use on patients with diabetes.
• · Do not use on patients under the age of 18 or individuals with open bone growth plates.

Warnings

• · WARNING: This device should be used under the continued supervision of a licensed health care practitioner.
• · WARNING: THIS PRODUCT CAN CAUSE BURNS AND SKIN IRRITATION. Your risk of burning increases as you age. Check skin frequently during use for signs of skin irritation or burns.
• · WARNING: Use carefully. Remove immediately if the knee becomes too hot or discomfort occurs.
• · WARNING: Do not use with pain rubs, medicated lotions, creams or ointments.
• · WARNING: Do not use with other forms of heat. This may cause burns.
• · WARNING: Precaution should be taken prior to using this device on patients with neoprene allergies.
• · WARNING: Precaution should be taken when using this device on the elderly or incapacitated persons. The unattended use of OrthoPods by these patients may be dangerous.
• · WARNING: Precaution should be taken when using this device on patients with sensitive skin. If the patient experiences skin irritation, discontinue the use of the device and consult your licensed health care practitioner before using the OrthoCor Active Knee System again.
• · WARNING: Equipment is not suitable for use in the presence of a flammable anesthetic mixture with air o r with oxygen or nitrous oxide or oxygen enriched atmospheres.
• · WARNING: Do not apply the OrthoPods directly to bare skin as it may cause burns.
• · WARNING: Do not open or puncture the OrthoPods.
• · WARNING: Do not let the contents of the OrthoPods make direct contact with your mouth or eyes. Immediately and thoroughly rinse with clean water, if contact with OrthoPods’ contents occurs.
• · WARNING: Do not ingest the contents of the OrthoPods. IMMEDIATELY CALL the nearest Poison Control Center if OrthoPods’ contents are ingested.
• · WARNING: Do not over-tighten the Knee OrthoCuff as this may restrict blood flow and result in injury.

Cautions

• · CAUTION: Use this device only in the prescribed manner and for the prescribed diagnosis.
• · CAUTION: KEEP AWAY FROM WATER. Use in dry environment.
• · CAUTION: The device is not indicated for treatment of deep tissue such as internal organs.
• · CAUTION: Do not use while the OrthoCor Active Knee System is charging.
• · CAUTION: Do not machine wash the OrthoCor Active Knee System.
• · CAUTION: Do not crush the OrthoSource or the Knee OrthoCuff as this may damage the electronics.
• · CAUTION: Do not reuse the OrthoPods.
• · CAUTION: Removing the OrthoPods will stop the treatment.
• · CAUTION: The AC adapter must be disconnected from the OrthoSource for treatment to occur.
• · CAUTION: Keep out of reach of children.
• · CAUTION: For external use only.
• · CAUTION: NEVER heat the OrthoCor Active Knee System or OrthoPods in the microwave as the system could catch on fire.

To purchase the OrthoCor device, please visit our store…