Surgery – Instruments – Electrical application
Reexamination Certificate
1996-03-19
2002-10-01
Nasser, Robert L. (Department: 3736)
Surgery
Instruments
Electrical application
C606S041000, C607S115000
Reexamination Certificate
active
06458121
ABSTRACT:
COPYRIGHT NOTICE
A portion of the disclosure of this patent document contains material which is subject to copyright protection. The copyright owner has no objection to the facsimile reproduction by anyone of the patent disclosure, as it appears in the Patent and Trademark Office public patent files or records, but otherwise reserves all copyright rights whatsoever.
BACKGROUND OF THE INVENTION
The invention disclosed herein relates to an apparatus for administering electromagnetic energy to tissue for medical and research purposes. In particular, the present invention relates to such apparatus which administers the electromagnetic energy athermapeutically (non-thermally). Also, the invention relates to a method for providing and updating patient and research files which store information regarding the treatment parameters and the patient or research project.
Prior art apparatus for administering high frequency electromagnetic energy athermapeutically has been available for many years from Diapulse Corporation of America, of Great Neck, N.Y. Such apparatus, referred to by Diapulse Corporation of America as the “Diapulse Wound Treatment System”™ (“DWTS”™ ), and referred to herein as “DIAPULSE® apparatus,” has been used extensively for the athermapeutic treatment of damaged tissue, and treatments using such apparatus have come to be identified as “DIAPULSE® treatments” or “DIAPULSE® Therapy”. The following patents relate to earlier DIAPULSE® apparatus, including the treatment head thereof: U.S. Pat. Nos. 2,276,994; 2,276,995; 2,276,996; 3,043,310; 3,181,535; 3,464,010; 3,670,737 and 4,226,246; Canadian Patent No. 679,371; and French Patent No. 2,301,965. The entire disclosures of all of those patents are hereby incorporated herein by reference.
DIAPULSE® apparatus available from Diapulse® Corporation of America generates and delivers short bursts of high peak power RF electromagnetic pulses to an area to be treated in or on the patient's body without causing any significant rise in temperature in the treated area. A DIAPULSE® treatment applies the energy to the desired treatment area by radiating it from a treatment head placed adjacent the treatment area, either in direct contact with or in close proximity to the treatment area. The specific operating parameters of DIAPULSE® treatments are: radiation of RF electromagnetic pulses of 27.12 MHz (11 meter band) in short, squared bursts of 65 &mgr;sec., at selectable burst repetition rates between 80 to 600 bursts per second (duty cycle between 0.5% and 3.9%), at selectable peak powers between about 300 and about 1000 watts, providing average powers of from about 1.5 W to about 38 W. Pulse frequencies of 0.5 of 27.12 Mhz and 1.5 of 27.12 Mhz may also be used, i.e. pulse frequencies of 13.56 MHz and 40.68 Mhz, respectively. The treatment head size and the treatment area size are such, that with the parameters given above, the DIAPULSE® treatment is athermapeutic, and the pulsed energy delivered to the treatment area is “non-thermal” in a medical sense.
The efficacy of the high amplitude, short duration electromagnetic pulses applied in DIAPULSE® treatments resides in the ability of these pulses to affect the electrical state of living cells, rather than to generate heat. As understood, these high amplitude, short duration electromagnetic pulses achieve beneficial effects by accelerating the return of the electrical state of damaged tissue to its normal condition, thus hastening the resulting electrochemical and chemical responses, and increasing blood flow, which are involved in healing and pain relief. Scientific blind, double blind and control studies have proved that DIAPULSE® treatments accelerate the healing of tissue damaged by burn, laceration, contusion, abrasion and surgical intervention, reduce edema, erythema, and inflammation, and prevent and relieve acute and chronic pain. These studies also show DIAPULSE® treatments to be effective in the treatment of a wide range of specific applications from the treatment of head injuries, pressure ulcers and acute and chronic wounds (due to surgery and otherwise) to the treatment of ankle sprains. See, for example, Ross, Jesse, Utilization of Pulsed High Peak Power Electromagnetic Energy (Diapulse Therapy) to Accelerate Healing Processes, Digest International Symposium, IEEE Antennas and Propagation Society, Stanford University, Jun. 20-22, 1977, pp. 146-149; Ross, Jesse, Results, Theories, and Concepts Concerning the Beneficial Effects of Pulsed High Peak Power Electromagnetic Energy (Diapulse® Therapy) in Accelerating the Inflammatory Process and Wound healing, presented at The Bioelectromagnetics Society 3rd Annual Conference, Washington, D.C., Aug. 9-12, 1981; Ross, Jesse Evolution, Prevention and Relief of Acute and Chronic Pain with the Application of Diapulse® Therapy (Pulse of High Peak Power Electromagnetic Energy), published in Schemerz, 1/1984, pp. 9-16; Ross, Jesse, Biological Effects of pulsed Peak Power Electromagnetic Energy using Diapulse®, published in Emerging Electromagnetic Medicine, O'Connor, M. E., Bentall, R. H. C., Monohan, J. C., editors, Springer-Verlag, 1990, pp. 269-281; Itoh, Masayoshi et al., Accelerating Wound Healing of pressure Ulcers by Pulsed High Peak Power Electromagnetic Energy (Diapulse®), Decubitus, 4(1):24:February 1991; Pennington, Gerard M., et al., Pulsed, Non-Thermal, High Frequency Electromagnetic Energy (Diapulse®) in the Treatment of Grade I and Grade II Ankle Sprains, Military Medicine, Vol. 158, No. 2, February 1993; Sambasivan, M., Pulsed Electromagnetic Field in Management of Head Injuries Neurology India, (1993) 41 (Suppl.), pp. 56-59; Salzberg, Andrew C. et al., The Effects of Non-Thermal Pulsed Electromagnetic Energy (Diapulse®) on Wound Healing of Pressure Ulcers in Spinal Cord-Injured Patients: A Randomized Double-Blind Study, Wounds, Vol. 7, No. 1, January/February 1995, pp. 11-16; Tung, Shirley et al., The Application of Diapulse® in the Treatment of Decubitus Ulcers: Case Reports, Contemporary Surgery, Vol. 47, No. 1, July 1995, pp. 27-32.
There is a need, however, for an improved apparatus capable of administering DIAPULSE® treatments, and also capable of applying electromagnetic energy to a treatment area for modified DIAPULSE® treatments and for new applications, both thermal and non-thermal, including research.
SUMMARY OF THE INVENTION
It is an object of the invention disclosed herein to provide an improved apparatus for the application of electromagnetic energy for medical treatments and/or research.
It is another object of the invention to provide such treatment apparatus with improved and/or expanded control of treatment parameters.
It is another object of the invention to more precisely control parameters of medical and/or research treatments in an apparatus which delivers high frequency electromagnetic pulses to treatment areas; other objects are to do so using a minimal number of components, and to be able to vary such treatment parameters in software, in response to settings input by a user or in response to settings stored in the apparatus. Another object is to vary the settings stored in the apparatus at the site of the apparatus and/or remotely.
It is another object of the invention to control more closely the power output of high frequency electromagnetic pulses radiated by apparatus for conducting medical treatments and/or research. Another object is to provide for “fail-safe” operation in the sense that such apparatus does not radiate the electromagnetic pulses at unsafe power levels, or for time periods sustained for longer than the time periods of the bursts, or when the apparatus is not set to radiate the pulses.
It is another object of the invention to automatically store in apparatus for conducting medical treatments and/or research (or apparatus coupled thereto) treatment parameters and other information for each patient or research project and for each treatment session. Another object is to process and/or print these parameters and information either directly from or by the apparatus, or af
Rosenstock Yehuda
Ross David M.
Sadinsky Samuel
Diapulse Corporation of America
Myron Amer P.C.
Nasser Robert L.
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