Surgery: light – thermal – and electrical application – Light – thermal – and electrical application – Electrical therapeutic systems
Reexamination Certificate
2000-03-20
2002-09-24
Layno, Carl (Department: 3762)
Surgery: light, thermal, and electrical application
Light, thermal, and electrical application
Electrical therapeutic systems
C607S115000, C607S144000, C607S145000, C607S139000, C607S149000
Reexamination Certificate
active
06456884
ABSTRACT:
BACKGROUND OF THE INVENTION
1. Field of Invention
The present invention relates generally to the field of orthotic devices and appliances; more particularly to orthotic devices and appliances in combination with electrotherapy useful for restoring movement to a connective joint of a mammalian body; and still more particularly to orthotic devices and appliances in combination with electrotherapy used to reverse contractures due to immobility and neurological dysfunction.
2. Background Discussion
Webster's New Collegiate Dictionary defines “orthotics” as “a branch of mechanical and medical science that deals with the support and bracing of weak or ineffective joints or muscles.”
Orthotic devices and appliances, commonly referred to just as “orthotics”(in spite of the broader dictionary definition of orthotics) have been utilized for many years by physical therapists, occupational therapists, and certified orthotic fitters to assist in the rehabilitation of loss of range of motion (LROM) of patients joints and associated limbs or adjacent skeletal parts of the patients' body.
Orthotics, as well as splints, have been designed both to maintain and to restore the range of bodily motion due to LROM. Such loss of range of motion may, for example, be caused by traumatic injury, rehabilitation following joint or limb surgery, and contracture due to immobilization caused by neuromuscular disorders (e.g., stroke and closed head injury) and other disease processes that significantly limit a patients ability to use a joint for normal activities of daily living (ADL).
Two fundamentally different types of contractures exist which clinically should have two different treatment protocols. The difference in these two types of contractures is the basis for the clinical techniques and design of the orthotics of the present invention which will be described below.
A first one of these two fundamentally different types of contracture may be defined as a fixed, high resistance of muscle to passive stretch resulting from fibrosis of the muscles and joints, or from disorders of the muscle fiber resulting in LROM, for example, of a patient's arm or leg. In this regard, Webster's Dictionary defines “contracture” as “a permanent shortening (as of muscle, tendon and scar tissue) producing deformity or distortion.”
This first type of contracture is usually due to trauma, injury, or surgical intervention affecting the joint, as may be typical of sports injuries and the treatment thereof. As the injured tissue heals, edema, post trauma or surgically affected tissue regeneration and other natural healing processes result in fusing together of what were, prior to the trauma, separate, pristine connective tissues, that is, the collagen fiber matrix (depicted diagrammatically in
FIG. 1A
hereof), capable of easily gliding over one another, as is needed for normal joint movement and related muscle elongation.
However, post-trauma, this collagen fiber matrix becomes random and irregular (depicted diagrammatically in
FIG. 1B
hereof), and neither elongates nor stretches compared to non-traumatized collagen fibers. This fusing together or adhesion of connective tissue structures (e.g., ligaments, tendons, synovial membrane, fascia and fibrous joint capsules) is the result of the tissues being invaded by developing undifferentiated scar between adjacent tissue, thereby diminishing or preventing the mutual gliding after early healing of the trauma or post-surgical trauma has been accomplished.
Such fusing together of connective tissue is a leading cause of lags (a non-specific indictment of the motor system's failure to move the affected joint through the full available passive range) relating to tendon gliding, depending on their strategic placement in reference to structures crossing the joint. With limited mobility and associated extensor muscle atrophy, combined with the formation of adhesions and scar tissue in the form of a significantly increased number of joined fiber matrix junctions, the muscle fibers become shortened.
The restoration of full range of motion where fibrosis of the muscle fiber with scar tissue and adhesions are present, requires that the adhesions and scar tissue or fused fiber matrix junctions be “worked through” or broken to restore normal functional elongation or stretch. The term “no pain, no gain” (of increased ROM) is associated with the process of breaking through joined or fused fiber matrix junctions to restore full elongation of the connective tissue, tendons and muscles associated with the trauma-affected joint.
Heretofore known orthotics are primarily designed to treat this first type of contracture, but have also been used to treat contractures caused by immobility and neurological dysfunction (described below). However, such orthotic devices are not, as far as is known by the present inventor, best suited for such additional purpose.
The second and very different type of contracture results from joint immobility—not joint-related trauma or surgical repair of a joint. Contracture resulting from immobility is simply a shortening and thickening of the connective tissue, tendons and muscles (depicted in
FIG. 1C
hereof) that restrict the ROM of a joint. In such situations, the muscle fibers still retain their original uniform shape and there are no adhesions or scar tissue or significantly increased joined fiber matrix junctions to break through in order to restore full range of motion.
In contrast to trauma-caused contractures, contractures due to immobility do not need a “no pain, no gain” approach to restoring the normal range of motion, and, in fact, such an approach can actually do more harm than good. As mentioned above, the collagen fibers of a contracture due to immobility are simply shorter and thicker, and will respond to appropriate stretching techniques and motion of the joint to restore LROM. The stretching technique usually used for contractures caused by immobility is Range Of Motion (ROM) Therapy and the use of Low-Load Protracted Stretch/Stress (LLPS) or “extended stretch” static or dynamic orthotic devices.
According to authors Kenneth R. Flowers and Susan L. Michlovitz in their article titled “ASSESSMENT AND MANAGEMENT OF LOSS OF MOTION IN ORTHOPEDIC DYSFUNCTION” (published in Postgraduate Advances in PHYSICAL THERAPY, American Physical Therapy Association, 1988 II-VIII), Total End Range Time (TERT) in conjunction with LLPS is the key to restoring full ROM.
All contractures, whether caused by injury, surgery, or immobility, limit range of motion of the affected joint and make simple activities of daily living, such as eating and self-dressing, more difficult, if not impossible. Moderate to severe contractures can be debilitating, and can leave afflicted individuals bed-bound and unable to care for themselves in the most basic daily living tasks. Even mild contractures due to immobility can progress to severe contractures if proper intervention is not prescribed and implemented so long as the immobility continues.
Electrotherapy has been used extensively in the rehabilitation of joint and muscle related injury, pain, and LROM. Electrotherapy also has demonstrated other valuable healing properties. Many forms of electrotherapy exist, and are characterized by the wave form of the electrical current. The wave form “rate” or frequency refers to the number of pulses delivered per second. Pulse rate is the number of pulses in each energy wave. Pulse width is the length of time each energy burst stays on (for example, double pulse width to double the energy in that pulse). Pulse amplitude or height of the pulse increases as the amplitude setting is increased. The total energy per pulse is determined by the amplitude and pulse width. Many variations of electrotherapy wave forms exist that are utilized therapeutically for joint rehabilitation, pain management, and the healing properties provided by electrical stimulation.
The use of transcultaneous electric neuromuscular stimulation or TENS has been used extensively to treat muscle injury and rel
Layno Carl
Stout, Uxa Buyan & Mullins, LLP
Trestles Healthcare, Inc.
Uxa Frank J.
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