Method and system for neural tissue modification

Surgery: light – thermal – and electrical application – Light – thermal – and electrical application – Thermal applicators

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A61F 200

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active

061610488

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BRIEF SUMMARY
FIELD OF THE INVENTION

This invention relates generally to technological advances in the medical field and systems and procedures for prolonging and improving human life. More particularly, this invention relates to a method and system for altering or modifying neural tissue in a human body by using a modulated radiofrequency generator coupled to a signal applicator system that is strategically located in tissue near a patient's neural system to relieve pain without heating it to lethal levels.


BACKGROUND OF THE INVENTION

In the past, radiofrequency (RF) generators and electrodes have been applied near or in neural tissue, for relieving pain or modifying its function. By way of one example, a lesion generator identified by Model No. RFG-3C RF, available from a company named Radionics, Inc., located in Burlington, Mass., has electrodes, which may be placed near a desired neural tissue area. The desired neural tissue area is heated by radiofrequency (RF) resistive power dissipation of the generator power deposited in the tissue. In some cases, thermal monitoring by a thermo sensor in the electrode is used to control the process. It is common to form heat lesions with tissue temperatures ranging from 60 to 95 degrees Celcius (.degree. C.). Tissue generally dies when heated to about 45.degree. C. to 50.degree. C., which causes the patient to suffer severe, if not, unbearable pain. The pain levels are so intense, that local or general anesthetic is often required during such a procedure. Use of local or general anesthetic exposes a patient to undesired risks, and the destructive nature of and unpleasant side effects of the radiofrequency (RF) heat lesions are limitations of this technique, which is well known. Heat lesion generators typically use continuous wave radiofrequency (RF) generators with radiofrequency ranges from 100 Kilo Hertz to several Mega Hertz. Heat lesion generators are available from several companies such as Radionics, Fisher, OWL, Elekta, Medtronic, Osypka, EPT, and so on. The theoretical aspects and use of RF lesion generators and electrodes for relieving pain and functional disorders is discussed in various papers, two of which are: (1) Cosman, et al., "Theoretical Aspects of Radiofrequency Lesions and the Dorsal Root Entry Zone," Neurosurgery 15:945-950, 1984; and (2) Cosman E R and Cosman B J, "Methods of Making Nervous System Lesions," in Wilkins R H, Rengachary SS (eds): Neurosurgery, New York, McGraw-Hill, Vol. III, 2490-2498, 1984.
Neural stimulation has also recently become a common method for pain therapy. For neural stimulation, stimulus generators are generally used, which typically have output levels between 0 to 10 volts (or zero to several milliamperes of current criteria are used). A variety of waveforms and pulse trains in the "physiologic" frequency ranges of 0 to about 300 Hertz are also typically used. This output is delivered to electrodes placed near to in neural tissue on a temporary basis (acute electrode placement) of permanent basis (chronic electrode implants). Such stimulation can relieve pain, modify neural function, and treat movement disorders. Typically, in most cases the stimulation must be sustained to have long-term effects. That is, usually when the stimulus is turned off, the pain returns or the therapeutic neural modification ceases after a short time (hours or days).
Thus, it is standard practice to use permanent implant electrodes and stimulators, which may be operated on battery power or induction driven. An example of such a commercially available system is one manufactured by Medtronic, Inc., located in Minneapolis, Minn. With permanent implant electrodes and stimulators, the stimulus is usually sustained or repeated on an essentially continuous basis for years, to suppress pain or to treat movement disorders, for example, Parkinsonism, bladder control, spasticity, etc. Stimulators deliver regular pulse trains or repetitive bursts of pulses in a range between 0 to 200 Hertz, which corresponds to a human body's physiological range of neural freq

REFERENCES:
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patent: 5233515 (1993-08-01), Cosman
patent: 5433739 (1995-07-01), Sluijter et al.
patent: 5951546 (1999-09-01), Lorentzen
patent: 5983141 (1999-11-01), Sluijter et al.
Cosman, et al.; Theoretical Aspects of Radiofrequency Lesions and the Dorsal Root Entry Zone; (1984); Neurosurgery; 15: pp. 945-950.
Cosman, et al,; Method of Making Nervous System Lesions, in Wilkins RH, Rengachary SS (eds); (1984); Neurosurgery, vol. III; pp. 2490-2498.
Salkoff; Temperature-induced seizure and frequency-dependent neuromuscular block in a ts mutant drosophilia; (1978); Nature (UK); 273, No. 5658: pp. 156-158.
Guttman, et al.; Squid axon membrane response to white noise stimulation; (1974); Biophys. J. (USA); 14, No. 12: pp. 941-955.

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