Drug – bio-affecting and body treating compositions – Designated organic nonactive ingredient containing other... – Solid synthetic organic polymer
Reexamination Certificate
2000-10-06
2003-10-14
Celsa, Bennett (Department: 1639)
Drug, bio-affecting and body treating compositions
Designated organic nonactive ingredient containing other...
Solid synthetic organic polymer
C424S078020
Reexamination Certificate
active
06632845
ABSTRACT:
BACKGROUND OF INVENTION
1. Field of the Invention
The present invention generally relates to a method for improving sensory integration related to the central nervous system and muscle tone throughout the body and extremities by applying polyacrylamide gel to the surface of skin that generally overlies target muscle areas. Sensory integration is a neurological process in which a brain organizes sensory information received from one's body or environment for use in bodily movement, body awareness and the body's senses. As polyacrylamide gel is applied to the skin surface, a cooling effect of the gel on the skin stimulates peripheral nerves underlying the skin. The stimulated nerves in turn innervate muscles for a short period of time. The brain organizes the sensory information received from the peripheral nerves resulting in an overall improvement of neuromuscular motor responses of the body.
2. Description of Related Art
Muscle control of individuals can become compromised due to muscle inactivity, cerebral palsy, brain damage, musculature and neural diseases, congenital deformities, injuries to limbs and nerves, head injuries, hypotonia, and autism among other reasons. The lack of muscle control often results in the decrease or loss of muscle tone, which may progress to muscle atrophy and the loss of muscle mass.
The health profession has created several techniques to improve the muscle motor control of patients that suffer from brain damage and other conditions affecting the musculature. These methods focus on a patient's tactile sensation to movement (sensory stimulation), the reflexive response of muscles to tactile stimulation, and the importance of repeating the sensory stimulation procedures for teaching muscle control.
One approach emphasizes controlled sensory stimulation of the muscles by stimulating the overlying skin. These methods are based upon the idea that individuals develop motor patterns from the fundamental reflex patterns present at birth. The motor patterns develop over time as an individual is exposed to sensory stimulation through experiences of life in his or her environment. As the individual responds to the sensory stimulation correctly, the individual learns to increasingly gain more voluntary control over his or her muscles. Thus, an individual suffering from brain damage or other condition effecting muscle control could be treated by applying appropriate sensory stimulation to a sensory receptor similar to what would occur in the normal developmental process in utero. Such sensory stimulation creates a reflex response from the musculature and the patient learns to gain muscle control as the method is repeated. For an individual suffering from a hypotonic muscle condition, the reflex response to sensory stimulation, in addition to gaining muscle control, would also improve the muscle tone and stop the progression of muscle atrophy.
Current theories of treating hypotonic muscles attempt to normalize the tone and control of muscle responses through appropriate controlled sensory stimulation by evoking a reflexive muscle response. The process follows that of the development of an individual. Thus, therapeutic methods are based upon the developmental stage of an individual. The treatment starts at the level of muscle control of the individual and progressively advances the individual to greater and greater control of his or her muscles. As the individual learns to control muscles and muscle groups, the individual can increasingly gain purposeful control of overall body movement and perform activities of daily living. Finally, the current theories stress that repetition of sensory stimulation and the resultant reflexive muscle response is necessary for the individual to learn muscle control.
Tactile Stimulation (Brushing)
One method of sensory stimulation includes quickly brushing the skin with a soft paint brush such as a camel hair brush or a battery operated brush with revolving bristles. The skin that is brushed typically lies immediately over a target muscle or muscle group desired to be stimulated. If a patient lacks muscle control or muscle tone of the back, the sensory stimulation focuses upon the posterior primary rami of the peripheral nerves which innervate the tonic, deep muscles of the back. Thus, brushing the skin overlying the distribution of the posterior primary rami of the peripheral nerves results in the innervation of the back muscles causing increased muscle tone and control. Similarly, the anterior primary rami of the peripheral nerves innervates the superficial muscles. Thus, stimulating the skin over portions of the body innervated by the anterior primary rami improves the muscle tone and control of the superficial muscles of the body.
Similar to improving tone of the back muscles and superficial muscles, the muscle tone and muscle control of the extremities may also be improved using the skin brushing method. The effects of the sensory stimulation to the extremities, however, may often be first observed on the opposite side of the body. Thus, the brushing technique is often conducted on both the extremities which have muscle control and adequate muscle tone as well as the extremities which lack muscle control and are hypotonic.
The brushing stimulation is performed between approximately 5 to 30 seconds for each area where improved muscle tone and control is desired. If no reflexive response is noted after an area is brushed for approximately 30 seconds, the brushing stimulation is repeated from three to five times.
The theory behind the brushing method is that brushing the skin of an individual results in a nonspecific stimulation of the underlying muscles. Once stimulated, the muscles are latent, remaining unresponsive for approximately 30 seconds. After approximately 30 seconds, the muscles co-contract and contraction occurs. The muscles reach their maximum reflexive response varying in time from 30 seconds to approximately 40 minutes after stimulation. The maximum reflexive response time varies based upon the amount of time the muscle desired is to be stimulated, the disorder compromises muscle tone, and muscle control.
Once a patient has gained control of his or her muscles, the brushing technique is discontinued as continued sensory stimulation therapy becomes ineffective for further improvement.
Brushing techniques, however, often do not always provide the reflexive response that is necessary in some cases to promote muscle tone and help a patient gain muscle control. In these instances, a technique using temperature change to provide the necessary sensory stimulation may be used.
Thermal Facilitation (Icing)
Another technique that can be used to stimulate a reflex response of the muscles is thermal facilitation, commonly referred to as “icing.” Similar to stimulating the skin with a brush, thermal facilitation or icing involves holding ice on the skin or brushing ice across the skin surface over the area lacking muscle control and/or muscle tone.
Ice, a noxious sensory stimulus, causes a protective reflexive response of an individual's muscles when applied over the sympathetic chain of the nervous system. It can be pressed against the skin for three to five seconds to stimulate postural and muscle tone responses in patients. Ice may also be brushed across the skin surface to elicit reflexive responses of underlying muscles. The skin areas that are targeted are the same as are targeted in the skin brushing techniques, except that the distribution of the posterior primary rami along the back are avoided due to undesired sympathetic nervous system response.
Icing of the extremities has been performed by rubbing the ice across the palms, soles, and dorsal webs of the hands or feet. This creates a reflex response of the extremity muscles. When the muscles contract, physical resistance to the movement by a medical professional is often applied to reinforce the response and help the patient develop voluntary control over the muscles as well as expedite the development of muscle tone.
Icing, however, has a r
Celsa Bennett
Gassiraro Diane M.
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