1. Field of the Invention
The present invention relates to an apparatus for surface electrical stimulation and stabilization to treat disorders of the joints.
2. Description of the Related Art
Degenerative Joint Disease (DJD) and Osteoarthritis (OA) are disorders of the joints whose main symptoms are pain and restricted movement. DJD and OA typically strike the joints of the lower extremities, such as the hips, knees, ankles or toes, and hence, greatly decrease the freedom of mobility of a patient. The elderly population is the most susceptible to DJD and OA.
Joints consist of bones and soft tissue structures that are designed to move and tolerate the activities of daily living. Each joint is encapsulated in a protective sac-like structure called a bursa. The lining of the joint, called the synovium, produces synovial fluid that bathes and lubricates the articular surfaces of the joint and helps protect the cartilage, a rubbery tissue that guards the bone.
DJD and OA are progressive disease processes. The breakdown of cartilage that is seen with these conditions occurs in several steps. First, the synovial fluid becomes thinner and loses its elasticity and viscosity, which decreases its ability to cushion the knee joint. Without this cushioning effect, the cartilage in the joint may be more likely to “wear down,” and begins to deteriorate. Next, the surface of the smooth cartilage covering the joint softens and it begins to lose its ability to absorb the impact of movement and can be more easily damaged from excess use or shock. Finally, the joint may lose its shape as the cartilage breaks down and bony growths or bone spurs may form on the edges of the effected joint compartment. Small particles of bone or cartilage may float around in the joint space. All of these occurrences cause pain in the affected joint and greatly restrict its natural movement.
A typical standard of care for treatment of DJD and OA is Nonsteroidal anti-inflammatory drugs (NSAIDs). The efficacy of NSAIDs to treat DJD and OA may be dependent upon their analgesic or anti-inflammatory properties, or the slowing of degenerative processes in the cartilage. NSAIDs are commonly known to have toxic effects in the stomach, gastrointestinal tract, liver and kidney.
Another typical standard of care for treatment of DJD and OA is bracing of the joint. Typical braces relieve pain by reducing the compressive forces on the joint being braced. Braces may be worn for long periods of time and are especially effective at reducing pain from DJD and OA when the wearer is physically active. Numerous braces are described in the art, examples of which are described below.
U.S. Pat. No. 5,458,565 to Tillinghast, III describes an osteoarthritic knee brace having flexible upper and lower arm members rotatably connected to each other by a rotary hinge assembly and an inflatable or deflatable fluid-containing pad positioned between the hinge assembly and the knee joint. The upper and lower arm members are stressed away from the knee joint, thereby applying a restoring force to the knee joint across the hinge assembly and the pad.
U.S. Published Patent Application No. 2006/0135900 to Ingimundarson et al describes a knee brace having a flexible proximal shell and a flexible distal shell. The proximal and distal shells each include a body portion and a compliant edge. The compliant edges are formed from flexible resilient material that is configured to extend beyond the outer perimeter of the body portion of each the proximal and distal shells.
Another typical standard of care for DJD and OA is surface electrical stimulation (SES). SES increases blood flow to stimulated areas and has a beneficial effect on the production and quality of the synovium and the resultant synovial fluid. SES provides an effective, non-surgical, non-pharmaceutical method of treating DJD and OA that patients can self-administer.
U.S. Pat. No. 5,273,033 to Hoffman describes a method for treating arthritic joint symptoms by applying electrical impulses via electrodes. The electrical impulses are initially applied with an amplitude sufficiently high to be sensed by the patient, followed by continuing application at a reduced amplitude subsensory to the patient. This method allows for a reduction of pain and joint stiffness, while helping to increase the range of motion of the joint.
U.S. patent application Ser. No. 10/659,278, referenced above, describes a method and device for improving the production and quality of synovial fluid in a joint through SES. Use of the method and device described causes a decrease in the progression of joint deterioration.
U.S. Pat. Nos. 6,393,328 and 6,988,005 to McGraw et al. describe portable electro-medical devices that are easy to use and have safety features that make them amenable to home use. The devices described are capable of applying many types of electro-medical treatment, including various types of stimulation that can be used for SES, as described below.
While the above methods of treating OA and DJD have been used with varying levels of effectiveness, there remains a need in the art for methods and devices that allow patients greater mobility with relief of OA and DJD symptoms, while simultaneously allowing the symptoms to be treated. A combination brace with SES can have greater benefit than stimulation alone or bracing alone. The present invention is used for the treatment and amelioration of joint disorders of, but not limited to, the hips, knees, ankles, toes, back, neck and shoulders. The present invention is used to treat a variety of joint disorders no matter how caused, such as through degenerative processes, wear and tear, or other causes. The present invention is used to prevent the development of a joint disorder, wherein the joint disorder is predicted due to factors including, but not limited to, generic predisposition or prior injury to a joint.
The present invention addresses the above-described conditions and needs, and an object of the present invention is to provide an apparatus for surface electrical stimulation and stabilization to treat disorders of the joints.
According to one aspect of the present invention, there is provided an apparatus for imparting an electrical signal into an articular segment of the human body. The apparatus has a stabilizer that actively supports the articular segment while allowing for substantial mobility, at least two signal applicators mounted within the stabilizer, and a signal generator electrically connected to the signal applicators for transmitting electrical stimulation to the articular segment.
In one aspect of the present invention, the stabilizer causes the relief of pain by alleviating pressure on at least one compartment of the joint while the signal applicators deliver electrical stimulation for treatment of the joint. As the stabilizer allows for substantial mobility, the wearer is free to move about and be physically active while wearing the apparatus.
In a specific example of the present invention, there is provided an apparatus for imparting an electrical signal into a leg and knee portion of the human body. The apparatus has a knee brace for stabilizing the leg and knee portion while allowing for substantial mobility, at least two signal applicators mounted within the knee brace and a signal generator electrically connected to the signal applicators for transmitting electrical stimulation to the leg and knee portion.
In another aspect of the present invention, the apparatus imparts an electric signal that mimics a pattern of normal physical activity by sequencing at least two muscle groups.
In a still further aspect of the present invention, the apparatus is designed for convenient home use. A patient wishing to treat a joint disorder may simply wear the apparatus while going about their daily activities. Further, as the signal applicators may be fixed in place within the stabilizer, they may be positioned by a medical professional so that the signal applicators will be in the proper spatial orientation relative to the joint to be treated each time the apparatus is worn. That way, proper signal applicator positioning may be assured and the instances of incorrect signal applicator placement by the patient may be greatly reduced.
The above and further objects and features of the invention will more fully be apparent from the following detailed description with accompanying drawings.
Referring to the drawings, wherein like reference numerals represent like parts throughout the various drawing figures, reference numeral 10 is directed to an apparatus for surface electrical stimulation and stabilization to treat disorders of the joints. The apparatus 10 has a stabilizer for stabilizing a joint or articular segment of the human body, a signal generator 30 and at least two signal applicators 50, 60.
In the embodiments set forth below, the articular segment described is a leg L and the joint being treated is a knee K. However, it is also contemplated that the present invention may be used for electrically stimulating and stabilizing other articular segments with joints including, but not limited to, elbows, ankles, shoulders, hips, toe joints and finger joints.
In a preferred embodiment, and with reference to
Alternatively, a double-hinge 22, 24 brace 20a can be used, as illustrated in
In addition to the unloader-type brace 20 embodiment shown in
The signal generator 30 is a stimulator, such as the portable electro-medical device described by McGraw et al. in U.S. Pat. Nos. 6,393,328 and 6,988,005. The signal generator 30 of the apparatus 10 includes controls for controlling the amplitude and frequency of the electrical signals, at least one output cable, and a power source.
Referring to
The signal generator 30 is electrically connected to the signal applicators 50, 60 via the output cable of the signal generator 30 to produce electrical stimulation for the passing of various types of current across the skin. Examples of this type of stimulation include, but are not limited to, Transcutaneous Electrical Nerve Stimulation (TENS), NeuroMuscular Electrical Stimulation (NMES), Interferential Stimulation, Diadynamic Stimulation, High Volt Galvanic Stimulation (HVGS), Electro-Magnetic and Pulsed Electro-Magnetic Field Stimulation (EMF & PEMF) and Micro-current Stimulation.
In another embodiment, apparatus 10 can be configured for use with other stimulators and electro-medical devices that allow for generating an electrical signal to be applied to the articular segment of the body.
Referring to
The apparatus 10 stimulates the effector muscle groups to simulate a pattern of normal action and function of the joint and its surrounding muscles that mimics activities of daily living (walking, running), but does not produce the destructive wear and tear on the knee K that would normally be seen in a weight bearing situation. As show in
With further reference to the electrode pads 52, 54, 56, 58, the first electrode pad 52 is preferably an anode and the second electrode pad 54 is a preferably a cathode electrically connected to the signal generator 30 on a first channel. The third electrode pad 56 is preferably a second anode and the fourth electrode pad 58 is preferably a second cathode both electrically connected to the signal generator 30 on a second channel. The amplitude for this sequential or pattern type stimulation that mimicks the normal action of the affected joint can range from about 5 mA to about 100 mA as rated into a 500 ohm load, and the duration of stimulation can range from about 10 minutes to about 10 hours per day. This stimulation produces the normal vegetative functions of the knee K, such as production of synovial fluid without further degradation of the knee K.
Another embodiment of the present invention is shown in
With continuing reference to the electrode pads 62, 64, 66, 68, the first pair of electrode pads 62, 64 and the second pair of electrode pads 66, 68 may form a criss-cross pattern to box-in the knee K, as shown in
Alternative stimulation patterns, including those that do not simulate natural function, are also contemplated for use in the present invention 10.
Although the invention has been disclosed in its preferred forms, the specific embodiments thereof as disclosed and illustrated herein are not to be considered in a limiting sense, because numerous variations are possible. The subject matter of the invention includes all novel and non-obvious combinations and sub-combinations of the various elements, features, functions, and/or properties disclosed herein. The following claims define certain combinations and sub-combinations of features, functions, elements, and/or properties that are regarded as novel and non-obvious. Other combinations and sub-combinations may be claimed through amendment of the present claims or presentation of new claims in this or a related application. Such claims, whether they are broader, narrower, equal, or different in scope to any earlier claims, also are regarded as included within the subject matter of the invention.
The present application claims the benefit of U.S. Provisional Application No. 60/706,445, filed on Aug. 9, 2005, whose disclosure is hereby incorporated by reference in its entirety. The present application is also related to U.S. patent application Ser. No. 10/659,278, filed on Sep. 11, 2003.
Number | Date | Country | |
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60706445 | Aug 2005 | US |