Pulsed electromagnetic energy treatment apparatus and method

Abstract

An apparatus and method for the treatment of chronic wounds using electromagnetic energy. The apparatus includes a generator and at least one applicator. The generator can produce electromagnetic energy and the applicator can apply the electromagnetic energy produced by the generator. A detector is disposed on the applicator that can measure the field strength of the electromagnetic energy applied.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS [0001] The present application is a continuation application of U.S. patent application Ser. No. 09 / 994,598, entitled IMPROVED PULSED ELECTROMAGNETIC ENERGY TREATMENT APPARATUS AND METHOD, filed on Nov. 20, 2001, which is a continuation application of U.S. patent application Ser. No. 09 / 231,790, entitled IMPROVED PULSED ELECTROMAGNETIC ENERGY TREATMENT APPARATUS AND METHOD, filed on Jan. 15, 1999, which claims priority of an earlier filed provisional application U.S. Ser. No. 60 / 071,396, filed on Jan. 15, 1998, the entire content of which is incorporated herein by reference.TECHNICAL FIELD OF THE INVENTION [0002] This invention related to electromechanical devices and methods for therapeutically treating human body tissue, and more particularly to a device for and a method of stimulating cell proliferation and related molecular events using high frequency pulsed electromagnetic energy. BACKGROUND OF THE INVENTION [0003] The present invention i...

AI Technical Summary

Benefits of technology

"The present invention is an improved method and apparatus for treating chronic wounds using pulsed electromagnetic energy. The invention has several advantages over existing devices, including cost-effectiveness, ease of use, and the ability to produce consistent treatment dosages without the need for manual adjustments. The invention can deliver simultaneous treatment to multiple wound sites and has low power requirements, making it battery-operated and portable. The invention also includes multiple sensor and control circuits to ensure precise treatment dosage and automatic control of the output specifications. The invention has multiple treatment ports and allows for independent and simultaneous treatment of different wound sites on the same patient. Overall, the invention improves the efficiency and effectiveness of electromagnetic energy treatment for wound healing applications."

Problems solved by technology

However, clinical studies have been disappointing and some experts have suggested that an alternative to single growth factors as therapeutic agents is the utilization of growth factors in combination to elicit synergistic clinical efficacy.

This lack of therapeutic efficacy may be in part because wound healing is a complex programmed sequence of cellular and molecular events, including macrophage activation during inflammation, cell migration, angiogenesis, provisional matrix synthesis, synthesis of collagen by fibroblasts, and reepithelialization.

Current pharmaceutical approaches do not fully mimic the necessary spatial and temporal patterns of growth factor activity needed to promote wound healing.

Overall, the complexity and variability of clinical wounds have limited pharmacological approaches to accelerate wound healing, leaving dressings and nonpharmacological ancillary modalities to dominate the market associated with wound management.

However, a subcategory of these devices utilize pulsed electromagnetic energy output to theoretically stimulate tissue without inducing a thermal response, although this has never been completely proven to occur using existing devices.

In the United States, where wound care constitutes less than 1% of aggregate health care dollars, treating and managing pressure ulcers requires an inordinate amount of material, human resources, time and money.

The costs associated with managing just one type of chronic wound alone, pressure ulcers, are extraordinary.

Application of external electrical and electromagnetic fields is now an increasingly standard therapy for the treatment of nonunion bone fractures, but these devices have seen limited use in other areas of healing.

Unfortunately, this has led to unsubstantiated claims that electrical stimulation cures a wide variety of health problems, thereby alienating the medical profession.

Moreover, published reports of double blind placebo-controlled clinical trials utilizing a RF transmission device (Diapulse) suggest that this ancillary treatment device significantly reduces wound healing time for chronic pressure ulcers as well as for surgical wounds.

While numerous high frequency devices using pulsed electromagnetic energy to stimulate tissue growth have been developed, none have effectively addressed the needs of patients and health care providers.

The device disclosed in U.S. Pat. No. 5,584,863 has high power requirements, requires numerous manual adjustments for effective operation, incorporates only a single applicator, fails to ensure constant, known and replicable treatment dosage outputs, and provides no confirmation that the applicator is properly located during treatment.

While the various and several prior art inventions, as described in the above referenced patents, produce electrical, magnetic or electromagnetic fields for treatment of tissue, virtually none of the prior art describes any credible cellular or physiological or molecular processes by which such energy fields specifically alter, induce or otherwise make happen an increase in cell growth, proliferation or density.

Additionally, none of the previous high frequency, high power devices utilizing pulsed electromagnetic energy output adequately addresses such practical design concerns as ease of use, simultaneous treatment of multiple wound sites on the same patient, dosage measurement, monitored dosage control and / or dosage compliance.

Images