STIMULATION DEVICE FOR TREATING OSTEOARTHRITIS

Cross-Reference to Related Application(s)

[001] This application claims priority to U S Provisional Application 60/927,354, entitled

Stimulation Device for Treating Osteoarthritis and filed on May 3, 2007, and further claims priority to U S Provisional Application 60/983,653, entitled Stimulation Device for Treating Osteoarthritis and filed on October 30, 2007, the contents of both of which are hereby incorporated herein by reference in their entireties

Field of the Invention

[002] The methods and devices disclosed herein relate to methods and devices for treating osteoarthritis More specifically, the devices and methods include the application of one or both of PEMF stimulation and thermal treatment to a target area

Background of the Invention

[003] The various embodiments disclosed herein relate to devices and methods for the treatment of osteoarthritis More particularly, the embodiments relate to portable, disposable pulsed electromagnetic field (PEMF) stimulation and thermal therapy devices for treating osteoarthritis and their methods of use

[004] 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

[005] 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

[006] 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

[007] 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

[008] 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

[009] 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 be the mechanism of transduction of the physical stresses into a signal that promotes bone formation In particular, studies of electrical phenomena in cartilage have demonstrated a mechanical-electrical transduction mechanism resembling those described in bone, appearing when cartilage is mechanically compressed Generating currents within cartilage is thought to stimulate chondrocyte activity, thus promoting the synthesis of cartilage New cartilage synthesis may work to combat the degeneration seen in osteoarthritis and therefore alleviate the symptoms of osteoarthritis [010] Thus, there is a need for an improved device and method to treat osteoarthritis

Brief Summary of the Invention

[011] 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 (EMT ² ) for treating knee osteoarthritis The EMT ² provides both transcutaneous pulsed electromagnetic field stimulation and thermal therapy For purposes of this application, it is understood that "thermal therapy" means any therapy that provides for application of heat or cold for purposes of treatment The EMT ² 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 or cooling and PEMF stimulation when inserted into the cuff, which provides the power and control for the coils The cuff may contain a rechargeable power source capable of delivering a recommended amount of therapy and the coils for delivering the PEMF stimulation The cuff may be fastened to the knee in a manner that directs the therapy to the medial and lateral areas of the joint Furthermore, the cuff may be designed such that it is aesthetically

pleasing and comfortable to wear during daily activities either over or underneath clothing, thereby increasing patient compliance

[012] 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 [013] Thus, the EMT ² devices and methods disclosed herein are designed with a powerful electromagnetic stimulating means 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 inventive device provides an easy-to-use, portable system that may have applications within a host of clinical and home health applications

Brief Description of the Drawings

[014] FIG 1 is a diagram illustrating a typical human knee joint model

[015] FIG 2 is a block diagram illustrating a stimulation device for treating osteoarthritis in the knee according to one embodiment

[016] FIG 3 is a front view of one embodiment of a stimulation device that is securable to a patient's knee for delivery of electromagnetic and thermal therapy

[017] FIGS 4A and 4B illustrate the stimulation device of FIG 3 secured to the patient's knee

[018] FIG 5 is an exploded perspective view of the stimulation device of FIG 3

[019] FIG 6 is an enlarged exploded view of a portion of the stimulation device of FIG 3

[020] FIG 7 is a perspective view of one embodiment of a stimulation device in the form of a patch that is securable to a patient's body for delivery of electromagnetic and thermal therapy

Detailed Description

[021] FIG 1 is a diagram illustrating a typical human knee joint model As shown in FIG

1 , the typical human knee joint includes a compartment filled with synovial fluid that is bounded by articular cartilage on the ends of the femur and tibia, respectively, and fibrous capsules In accordance with one embodiment of the devices and methods discussed herein, osteoarthritis in the knee _j oint may be treated by the application of heat or cold and specific and selective electromagnetic fields via coils positioned adjacent to the knee joint As will be discussed in more detail to follow, a signal generator means may provide the appropriate signals to the coils for generating the specific and selective electromagnetic fields The specific and selective electromagnetic field needed to treat

osteoarthritis in the knee joint may be calculated, and varies depending upon, among other factors, the dimensions of the tibia and femur and the severity of the symptoms Furthermore, a heating or cooling source may also be positioned adjacent to the knee joint to relieve pain, reduce patient discomfort, and increase range of motion The heating or cooling source can also be referred to as a "thermal exchange component," which, for purposes of the instant application, means any component or device that can be used to apply heat (or any temperature that is higher than the patient's body temperature or the ambient temperature) or cold (or any temperature that is lower than the patient's body temperature or the ambient temperature)

[022] More particularly, the implementations discussed herein relate to devices and methods for generating both (1 ) heat or cold and (2) selective pulsed electromagnetic fields for the treatment of diseased tissue in a joint, such as a knee joint The devices, which may be designed in numerous forms such as a knee brace or a small dermal patch, preferably offer transcutaneous stimulation for treating osteoarthritis The devices may be designed to provide stimulation directly to the afflicted joint to alleviate pain and increase range of motion

[023] As will be discussed in further detail in subsequent paragraphs, the various EMT ² stimulation device embodiments may be designed to attach to a patient for a prolonged period of time while having little disruption to daily activities and minimal skin irritation In addition, the stimulation devices may be designed such that it is aesthetically pleasing and comfortable to wear As a result of these and other design characteristics, patient refusal of treatment due to discomfort (ι e , patient "non-compliance") may be minimized

[024] Pulsed electromagnetic fields generate small, induced currents (Faraday currents) in the highly conductive extracellular fluid, which thereby mimics endogeneous electrical currents The endogeneous electrical currents are due primarily to movement of fluid containing electrolytes in channels of the bone containing organic constituents with fixed negative charges, generating what are called "streaming potentials " Studies of electrical phenomena in cartilage have demonstrated a mechanical-electrical transduction 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 proteoglycans and collagen in the cartilage matrix These streaming potentials serve a purpose in cartilage similar to that in bone, and, along with mechanical strain, lead to signal transduction that is capable of stimulating chondrocyte synthesis of matrix components

[025] In contrast to direct currents, PEMFs are able to penetrate cell membranes and either stimulate them or directly affect intracellular organelles As a result, the effect of PEMFs on extracellular matrices includes increased synthesis of cartilage molecules, thereby enabling a "remodeling" of the knee joint

[026] FIG 2 is a block diagram illustrating EMT ² stimulation device 10 for treating osteoarthritis in the knee according to one embodiment This device embodiment 10 has a signal generator 12, power source 14, first stimulating means 16A, and second stimulating means 16B First stimulating means 16A is coupled to first output 18A of signal generator 12 via first signal line 2OA Similarly, second stimulating means 16B is coupled to second output 18B of signal generator 12 via

second signal line 2OB In various embodiments, the first stimulating means 16A has either or both of an electromagnetic stimulating means 26A and a thermal exchange component 28A and the second stimulating means 16B has either or both of an electromagnetic stimulating means 26B and a thermal exchange component 28B

[027] First and second signal lines 2OA and 2OB are configured to deliver the signals generated by signal generator 12 to create the appropriate therapeutic stimulation via first and second stimulating means 16A and 16B First and second signal lines 2OA and 2OB may be "wired," such as with coaxial cable Alternatively, a "wireless" connection means, such as Bluetooth, may be used [028] Although stimulation device 10 is shown as having two output ports 18A and 18B for simultaneously and independently delivering output signals (either the same or different signals) to two stimulating means 16A and 16B, one skilled in the art will appreciate that the number of output ports and stimulating means may be varied without departing from the intended scope of the implementations disclosed herein Thus, embodiments of device 10 that include any number of stimulating means are contemplated For example, in one alternative embodiment, the device 10 can have one stimulating means

[029] Power source 14, which may be, for example a lithium battery pack, is provided for delivering a current input to signal generator 12 While shown in FIG 2 as a remote unit, power source 14 may be incorporated as part of or housed together with signal generator 12 Since the embodiments may be designed with low power requirements, power source 14 may be one capable of providing an average power input of less than about 300 mW per session As a result, power source 14 is generally small and lightweight In an alternative embodiment, the device 10 has two power sources - one to supply power to the signal generator and another to supply power to create the thermal exchange

[030] As shown in FIG 2, signal generator 12 may include voltage regulator 22 and microcontroller 24 Furthermore, first stimulating means 16A may include first electromagnetic stimulating means 26A and first thermal exchange component 28A, while second stimulating means 16B may include second electromagnetic stimulating means 26B and second thermal exchange component 28B In one embodiment, the first and second electromagnetic stimulating means 26A, 26B are first and second coils 26A, 26B Voltage regulator 22 may be used to provide various required supply voltages to first and second electromagnetic stimulating means 26A and 26B First and second electromagnetic stimulating means 26A and 26B may be triggered by microcontroller 24, which may be designed to generate accurate pulses at a particular triggering and switching frequency Output signals are delivered from microcontroller 24 to first and second stimulating means 16A and 16B, each of which is individually responsive to the signals to create a pulsed electromagnetic field [031] As shown in FIG 2, alternative embodiments of the device 10 may further include display 30 and monitoring means 32 Display 30 may be designed to display many different treatment parameters, including but not limited to a treatment mode, a power level, and an amount of time remaining in a treatment session

[032] Monitoring means 32 may be designed for monitoring one or more of the output conditions of stimulation device 10 In particular, monitoring means 32 may be configured to ensure

that accurate treatment dosages are delivered through first and second stimulating means 16A and 16B to the patient's knee One condition that may be monitored by monitoring means 32 is the electromagnetic field generated by first and second coils 26A and 26B In particular, monitoring means 32 may include circuitry to both detect the strength of the electromagnetic field and adjust the signals delivered to the coils if the sensed field is not in accordance with the desired treatment level A second condition that may be monitored by monitoring means 32 is tissue temperature generated by first and second thermal exchange component 28A and 28B If, for example, monitoring means 32 senses a tissue temperature that is out of an acceptable range and poses a danger of injuring tissue around the knee, monitoring means 32 may communicate with the patient through display 30 to instruct removal of device 10 from the patient's knee

[033] For example, in one embodiment, monitoring means 32 may include a signal detector coupled to first stimulating means 16A and/or second stimulating means 16B for measuring the energy emission from first and second coils 26A and 26B The signal detector may be designed so as to transmit a feedback signal to signal generator 12 for controlling the energy output The actual electromagnetic energy field, or treatment dosage, that is transmitted from first and second stimulating means 16A and 16B may be measured directly by embedding the signal strength detector within the stimulating means The signal level measured by the signal detector may then be sent to signal generator 12, where it may be used as a feedback control signal to control the output signals of the generator If, at any time, monitoring means 32 detects a field strength outside of the desired range of the treatment mode, display 30 may display an audible, visible, tactile, or other type of alarm to inform the patient and/or physician of a malfunction in the treatment mode Furthermore, if the measured field strength is at or above a level that poses a risk of danger, the feedback circuit of monitoring means 32 may stop the treatment to ensure that the patient is not harmed As will be appreciated by one skilled in the art, monitoring means 32 may alternatively or additionally include a temperature sensor and associated feedback control to sense and control tissue temperature around the patient's knee

[034] As shown in FIG 2, device 10 may be connected to a computer system 34 to allow the physician to program treatment modes into microcontroller 24 In this manner, the physician retains control over the type of treatment that the patient receives since device 10 may be designed such that only the physician is able to access and modify the programmed treatment modes Through computer system 34, the physician may also monitor the treatment conditions to ensure that, for example, the correct field strength is being generated

[035] In order to make treatment with stimulation device 10 more convenient for both the physician and the patient, telemetry means 36 may be incorporated into the device In general, telemetry allows for the remote measurement and reporting of information of interest to a remote system or operator In addition, telemetry allows for the remote operation and control of a device by allowing the operator to remotely send instructions to or program the device

[036] With respect to stimulation device 10, telemetry means 36 enables the physician to remotely monitor the treatment as well as modify the treatment modes programmed into microcontroller 24 In this way, the physician has the ability to control and prescribe treatment modes

without the requirement of a face-to-face consultation with the patient, thus making treatment of osteoarthritis more convenient for both the patient and the physician In one embodiment, telemetry means 36 may operate using wireless communication, such as by utilizing a radio frequency system to implement the data link between the device and remote system However, telemetry means 36 may alternatively transfer data over other media, such as a telephone line, a computer network, or via an optical link

[037] Now that certain embodiments of the EMT ² stimulation device have been generally described in reference to the block diagram illustration of FIG 2, one exemplary embodiment of a stimulation device that may be worn by a patient for the treatment of osteoarthritis will be described In particular, FIG 3 illustrates a stimulation device 110, which generally includes a knee cuff 111 , a housing 131 in which a signal generator and a power source are positioned, a first stimulating means 116A, a second stimulating means 116B, and a fastening means 117 The housing 131 can be positioned anywhere on the cuff 111 The device 110 alternatively also has a display 130 that can display one or more treatment parameters, such as the treatment mode or the amount of treatment time remaining in a therapy session In the embodiment depicted in FIG 3, the display 130 is located on the housing 131 Alternatively, the display 130 can be positioned in any location from which the display is visible to the user during use Stimulation device 110 is a device for providing electromagnetic field stimulation and thermal therapy to a patient's body to promote healing In particular, stimulation device 110 may provide pulsed electromagnetic field stimulation and thermal therapy (via first and second stimulating means 116A and 116B) to a knee joint suffering from the effects of osteoarthritis to promote healing of the knee However, one skilled in the art will appreciate that various device embodiments disclosed herein may be useful to provide electromagnetic field stimulation and thermal therapy (EMT ² ) to various other locations on a patient's body to promote healing or provide a therapeutic effect

[038] Knee cuff 111 includes main body portion 113, first set of strap members 115A, and second set of strap members 115B First set of strap members 115A include first fastening members 117A, while second set of strap members 115B include second fastening members 117B As will be discussed in the following paragraphs, first fastening members 117A are configured to mate with second fastening members 117B in order to removably couple first set of strap members 115A to second set of strap members 115B and thus, to secure knee cuff 111 to the patient's knee [039] FIGS 4A and 4B illustrate stimulation device 1 10 secured to the patient's knee, according to one embodiment In particular, FIG 4A illustrates a front side of the patient's knee, while FIG 4B illustrates a back side of the knee Knee cuff 111 of stimulation device 110 is wrapped around the knee such that first set of strap members 115A having first fastening members 117A overlap with second set of strap members 1 15B having second fastening members 1 17B to secure the cuff at the desired location on the knee When properly secured to the knee, first stimulation means 116A is positioned at a lateral knee location, while second stimulating means 116B is positioned at a medial knee location In one embodiment, first fastening members 117A and second fastening members 117B form a hook-and-loop fastening means, such as that commonly known as VELCRO®, wherein first fastening members 117A are the "hook" portions and second fastening

members 117B are the "loop" portions However, other means of fastening may be used including, but not limited to, buckles, snaps, and zippers In alternate embodiments of knee cuff 111 , no fastening means is used Instead, the fabric forming the wrap is capable of being stretched and is able to hold itself in place due to the elasticity of the wrap

[040] FIG 5 is an exploded perspective view of stimulation device 110 according to a further embodiment As shown in FIG 5, first stimulating means 116A includes first coil 126A ₁ first stimulating means holder 125A, first stimulating means holder base plate 121A, first thermal exchange component 128A, and first stimulating means housing 119A First coil 126A of first stimulating means 116A is designed to be contained within the first stimulating means holder 125A The first stimulating means holder base plate 121 A provides a base for the first stimulating means holder 125A to attach to in order to be joined to the knee cuff by means of any one of such exemplary attachment mechanisms as, but not limited to, an irreversible snap-fit hook mechanism, ultrasonic welding, or glue In one embodiment, the first stimulating means holder base plate 121A may be permanently attached to the knee cuff 111 by sewing, glue, or any known attachment means First thermal exchange component 128A is designed to be contained within first thermal stimulating means housing 119A Housing 119A may then be enclosed on a back side by a thin plastic barrier 123A formed from a material such as Tyvek® The thin barrier 123A can be attached to the housing 119A by glue, heat seal, or a plastic snap-fit cover 118A First thermal exchange component 1 19A is insertable into first stimulating means holder 125A, which is coupled to knee cuff 111 as shown in the embodiment depicted in FIG 3

[041] Although not shown in an exploded view like first stimulating means 116A, second stimulating means 116B includes similar components in a similar configuration Thus, the discussion focuses on first stimulating means 116A for purposes of example only, but applies equally to second stimulating means 116B As a result, second stimulating means 116B includes similar components having similar reference numerals

[042] The signal generator 112 depicted schematically in FIG 5 includes a voltage regulator 122 and a microcontroller 124, which control the signals transmitted through the wire harness 132 to first and second coils 126A and 126B to provide the pulsed electromagnetic field to the knee The wire harness 132 is hidden within the different fabric layers of the knee cuff 111 Power source 114, which provides power to voltage regulator 122, is positioned in the same housing that contains the signal generator means 112 However, as discussed above, power source 114 may alternatively be positioned remotely from the signal generator means 112 In a further alternative embodiment, two power sources are provided one for the signal generator and one for the thermal exchange component In yet another embodiment, three power sources are provided one for the signal generator and one for each of the thermal exchange components In one embodiment, the power sources for the thermal exchange components are single-use heating mixtures that provide energy when exposed to air

[043] First and second coils 126A and 126B are either unipolar or bipolar electromagnets that generate a magnetic field when electrical current flows through them The magnetic field is created by passing an electric current through first and second coils 126A and 126B, which are

preferably formed from a long wire strand coiled around a core The "pulsed" electromagnetic field may be created by programming microcontroller 124 to turn the electromagnetic field on and off at a rapid rate

[044] Although first and second thermal exchange components 128A and 128B are not required components, incorporating them into first and second stimulating means 116A and 116B, respectively, may provide beneficial treatment results In particular, when used in combination with electromagnetic therapy, thermal therapy is helpful in treating the effects of osteoarthritis and improving patient compliance However, one skilled in the art will appreciate that embodiments of stimulation device 110 that apply only thermal therapy, only electromagnetic therapy, or a combination of both therapies are possible As a result, the stimulation devices described herein may be tailored to the particular needs of different patients

[045] Heat is a natural remedy that may be used to both relieve pain and reduce discomfort This is accomplished by stimulating the patient's thermoreceptors 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

[046] 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 128A and 128B 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 128A and 128B 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 128A and 128B 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 128A and 128B 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 128A and 128B may be pulsed such that the heat therapy is not constant

[047] In one embodiment, power source 114 is a lithium-polymer battery, which may be either a single-use battery or a rechargeable, multi-use battery If power source 114 is a rechargeable type battery, stimulation device 110 may be configured for attachment to a docking station for recharging the device Alternatively, the docking station may be designed to receive only power source 114, which may be made removable from stimulation device 110 As one skilled in the art will appreciate, numerous other types of power sources may be used to provide the requisite power to stimulation device 110 For example, stimulation device 110 may be designed to create power from

the patient's body movements Alternatively, stimulation device 110 may be powered through a chemical reaction with heat being the by-product In this case, the heat by-product may provide the heat therapy to the knee joint

[048] As shown in FIG 5, stimulation device 110 further includes display 130 for displaying one or more treatment parameters, such as the treatment mode or the amount of treatment time remaining in a therapy session Display 130 may utilize many different types of indicator means such as, for example, a light source, a heat-sensitive material that changes color (as a function of elapsed time), a digital timer, or sound repetition In addition, display 130 may function together with a monitoring means in order to transmit an audio, visual, or tactile-type message to the patient in response to the monitoring means sensing, for example, an electromagnetic field strength that is outside of that defined by the treatment mode In this instance, display 130 is useful to instruct the patient to remove the stimulation device or to call his or her physician

[049] FIG 6 is an enlarged illustration of the exploded perspective view of FIG 5, according to one embodiment In this embodiment, the stimulating means housings 119A, 119B as depicted in FIG 5 are insertable, replaceable units that can be easily and quickly inserted into and removed from the means holders 125A, 125B In one embodiment, the stimulating means housings 119A, 119B have connections that, upon insertion into the holders 125A, 125B, couple with connections in the holders 125A, 125B to supply power to the housings 119A, 119B [050] FIG 6 depicts one embodiment of a stimulation device 110 with insertable stimulating means housings 119A, 119B As shown in FIG 6, the stimulation device 110 has a metal plate 140A in the stimulating means housing 119A and a first pair of stimulating means holder spring-loaded metal contacts 142A When the stimulation device 1 10 is assembled as shown in the embodiment of FIG 3, the metal plate 140A on the stimulating means housing 1 19A is used to make an electrical connection with a pair of spring-loaded metal contacts 142A in the first stimulating means holder 125A The protrusions 133A on the stimulating means housing 119A can slide in and out of the grooves 134A on the stimulating means holder 125A and engage in the notches 135A to create a reversible mechanical snap-in feature that allows for secure insertion and removal of the housing 119A to the stimulating means holder 125A In an alternative implementation, the metal plate 140A in the stimulating means housing 119A makes contact with the first pair of stimulating means holder magnets that are inserted into a first pair of magnet notches in first stimulating means holder 125A for securing the housing 119A to the first stimulating means holder 125A In a further alternative, instead of a metal plate, the stimulation device 110 can have a pair of stimulating means magnets and a corresponding pair of stimulating means holder magnets

[051] The first pair of stimulating means holder spring-loaded metal contacts 142A are coupled to a corresponding pair of signal lines (not shown) in communication with signal generator 112 When first stimulating means housing 119A is positioned within first stimulating means holder 125A, the electrical connection between the metal plate 140A and the corresponding first pair of stimulating means holder spring-loaded metal contacts 142A creates a closed circuit that electrically couples first stimulating means 1 16A to signal generator 1 12 As a result, signal generator 112 is

able to communicate with first stimulating means 116A to deliver the prescribed treatment signals defined by the treatment mode programmed into microcontroller 124

[052] The embodiment of stimulation device 1 10 illustrated in FIGS 3 - 6 is a two coil arrangement with one coil on either side of the knee for generating the PEMF therapy In general, voltage regulator 122 is used to provide a constant supply voltage to signal generator 112, and first and second stimulating means 116A and 116B Microcontroller 124 triggers first and second coils 126A and 126B, thereby generating accurate pulses at a particular triggering and switching frequency defined by the designated treatment mode stored in the microcontroller 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 amplitude of the PEMF therapy

[053] The required penetration depth of the pulsed electromagnetic field generated by signal generator 112 and first and second stimulating means 116A and 1 16B may vary depending upon, for example, the size of the patient's knee region However, for an adult patient, the penetration depth is generally in the range of about 1 cm to about 5 cm Alternatively, the penetration depth is in the range of about 2 cm to about 4 cm In a further alternative, the penetration depth ranges from about 2 cm to about 2 5 cm This "penetration depth" parameter is necessary in order to estimate the magnetic field intensity needed to provide the therapy, which ultimately determines the power requirement of power source 114

[054] In general, the magnetic field intensity generated by a coil is measured in terms of

Tesla (T) and has the following approximate relationship with current flowing through the coil

where "B" is the magnetic field produced by the coil, "I" is the current through the coil, "R" is the radius of the coil, and "x" is the penetration depth of the PEMF

[055] According to one embodiment, the magnetic field strength B applied to the target body part of the patient ranges from about 10 μT to about 2,000 μT Alternatively, the magnetic field strength B ranges from about 20 μT to about 100 μT In a further alternative, the magnetic field strength B ranges from about 30 μT to about 50 μT In yet another alternative, the magnetic field strength B is about 40 μT According to one embodiment, the magnetic field produced by the coil is applied perpendicular to the coil

[056] In one implementation, the magnetic field is applied into the knee for a distance ranging from about 1 cm to about 5 cm into the knee Alternatively, the magnetic field is applied for a distance ranging from about 2 cm to about 4 cm into the knee In a further alternative, the magnetic field is applied to a distance ranging from about 2 cm to about 2 5 cm into the knee

[057] The coil, in accordance with one embodiment, has 20 turns of a 24 AWG wire around a core with a radius of about 2 centimeters with a pulsed current 712 mA Alternatively, the coil has

65 turns of a 28 AWG wire around a core with a radius of 1 5 cm with a pulsed current of 339 mA

[058] While a single-coil configuration is possible and within the intended scope of this application, the two-coil configuration uses about 20 times less power than the single-coil configuration because it requires a significantly smaller amount of energy to penetrate both the lateral and medial side of the knee Furthermore, embodiments having more than two coils are also contemplated

[059] In one embodiment, the PEMF therapy is applied for period ranging from about 30 minutes to about 4 hours Alternatively, the PEMF therapy is applied for a period ranging from about

1 hour to about 3 hours In a further alternative, the therapy is applied from about 1 5 to about 2 5 hours In yet another alternative, the therapy is applied for about 2 hours Further, the optimal treatment window may vary depending upon many factors, including, but not limited to, the field intensity provided to the knee, the severity of the osteoarthritis in the knee, and the physical dimensions of the knee

[060] According to one implementation, the triggering frequency ranges from about 1 Hz to about 100 Hz Alternatively, the triggering frequency ranges from about 5 Hz to about 50 Hz In a further alternative, the triggering frequency ranges from about 10 Hz to about 20 Hz In yet another alternative, the triggering frequency is about 15 Hz

[061] In accordance with one embodiment, the switching frequency ranges from about 50

Hz to about 100 kHz Alternatively, the switching frequency ranges from about 300 Hz to about 70 kHz In a further alternative, the switching frequency ranges from about 2 kHz to about 4 kHz In yet another alternative, the switching frequency is about 3 kHz

[062] In general, in order to achieve the optimal therapeutic effect with the PEMF, a triggering frequency in the range of about 15 Hz and a switching frequency in the range of about 3 kHz are desirable, although other triggering and switching frequencies are also contemplated

[063] As one skilled in the art will appreciate based upon the above disclosure, stimulation device 110 does not require connection to any external hardware while delivering the prescribed therapy Thus, stimulation device 110 is portable, and is designed such that it may be worn by the patient during their normal daily activities without discomfort Knee cuff 111 may be both ergonomically designed and cosmetically appealing to increase patient compliance with wearing the device

[064] First and second stimulating means 116A and 116B may be designed as complete or partial disposable units that may be discarded and replaced after a predetermined number of treatments For example, stimulating means housing 119A, which may include first thermal exchange component 128A and/or first coil 126A, may be removed from stimulation means holder 125A and disposed of by the patient upon expiration Optionally, display 130 may instruct the patient when the units have expired and require replacement The disposability feature of first and second stimulating means 116A and 116B may be advantageous because if one or more of the stimulating means stops functioning properly, it is only necessary to replace those components and not the entire stimulation device

[065] Another exemplary embodiment of an EMT ² stimulation device is depicted in FIG 7

The device 200 shown in FIG 7 has a PEMF generation component 202 and a thermal exchange

component 204 The PEMF generation component 202 is positioned between a first exterior layer 206 and a second exterior layer 208 According to one embodiment, the first layer 206 has an adhesive component 210 on at least a portion of the side of the layer external to the device 200 The adhesive component 210 is any known adhesive that allows for attaching the device 200 to the patient's skin

[066] In accordance with one implementation, the device 200 also has a power source (not shown) positioned in an external casing 212 positioned on the second layer 208 In a further embodiment, certain electronic components can be positioned in the casing 212 [067] Alternatively, the device 200 has two power sources (not shown) - one for the PEMF generation component 202 and one for the thermal exchange component 204 Two different power sources can help to maximize battery life Alternatively, one power source is provided for both the PEMF generation component 202 and the thermal exchange component 204 In a further embodiment, one power source is provided for the PEMF generation component 202, and the thermal exchange component 204 in this embodiment requires no power source, as explained in further detail below According to one implementation, the single power source or both power sources are positioned in the external casing 212 Alternatively, the single power source or both power sources are positioned between the first layer 206 and the second layer 208 In a further alternative, one power source is positioned in the external casing 212 and one power source is positioned in between the first 206 and second 208 layers

[068] In one embodiment, one or both of the power sources are a single-use or disposable power source Alternatively, the one or more power sources can be reusable or permanent power sources In a further alternative, the power source is any known power source for use with a PEMF stimulation device and/or a thermal exchange component

[069] In one embodiment, the device 200 is a single-use patch-like device Alternatively, the device 200 is a reusable device As shown, the device 200 has a square shape Alternatively, the device 200 can have a circular or round shape or any other known shape For example, in one embodiment, the device 200 may have any shape that maximizes attachment to the patient's skin and patient comfort

[070] In this embodiment, the PEMF generation component 202 is a coil configured to generate the pulsed electromagnetic field Alternatively, the PEMF generation component 202 can be any known component for generating a PEMF

[071] According to one implementation, the thermal exchange component 204 is a heat source such as, for example, a component having an exothermic chemical mixture For example, the heat source in one embodiment is a mixture containing iron powder, water, activated charcoal, and salt that oxidizes in air to generate heat One commercial example of such a mixture can be found in hand warming products sold by HeatMax®, which is located in Dalton, GA Another example of a heat source that can be used with the present embodiment is a mixture containing super-cooled sodium acetate Yet another example is a mixture containing calcium chloride or magnesium sulfate and water In a further alternative, the thermal exchange component can be any known component or device for generating heat

[072] In accordance with one implementation in which the thermal exchange component

204 is a heat source utilizing an exothermic chemical mixture the component 204 does not require a power source That is, the chemical mixture generates the exothermic reaction without the need for any battery or any other kind of power source

[073] Alternatively, the thermal exchange component 204 is a cooling source such as, for example, a component having an endothermic chemical mixture For example, the cooling source can be a mixture containing ammonium nitrate and water In a further alternative, the thermal exchange component 204 can be any known component for providing a temperature reduction [074] In one implementation, the first and second exterior layers 206, 208 are flexible or pliable layers The layer pliability or flexibility can, according to one embodiment, facilitate attachment of the device 200 to the patient's skin In one alternative embodiment, one or both of the exterior layers can be gas permeable In a further alternative, one or both of the exterior layers are permeable to oxygen The layers 206, 208 can consist of a biocompatible membrane such as, for example, the Tegaderm™ and Medipore™ products available from 3M™ Company, located in St Paul, MN [075] According to one embodiment, the adhesive component 210 is a hypoallergenic adhesive In a further alternative implementation in which one or both of the exterior layers 206, 208 are gas permeable, the adhesive component 210 is a porous adhesive that allows gas to pass through the adhesive and the gas permeable layer

[076] It is understood that this device 200 can be used to treat any joint or any other body part that might benefit from treatment with PEMF and thermal exchange In one embodiment, the target area is the knee It is further understood that more than one device 200 could be used to treat a target area The device 200 can be used to relieve osteoarthritis pain and increase range of motion

[077] One skilled in the art will appreciate that although the devices and methods have been described in reference to only a few embodiments of a stimulation device, these embodiments are provided for purposes of example and not limitation Accordingly, numerous other embodiments are possible and within the intended scope