Method for treating bone fracture

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

Reexamination Certificate

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C606S003000, C606S010000

Reexamination Certificate

active

06290714

ABSTRACT:

BACKGROUND OF THE INVENTION
This invention relates generally to laser apparatus and more particularly, to low level laser therapy apparatus.
High energy laser radiation is now well-accepted as a surgical tool for cutting, cauterizing and ablating biological tissue. High energy lasers are routinely used to vaporize superficial skin lesions, to make superficial incisions such as those required for plastic surgery, and to make deep cuts required for major surgical operations. Such lasers accomplish their results thermally, by heating the tissue.
Less well-known is that low levels of laser energy have a non-thermal, biostimulative effect on biological tissues. The therapeutic application of low level laser energy, frequently known as low level laser therapy (LLLT), produces beneficial clinical effects in the treatment of musculoskeletal, neurological and soft tissue conditions. LLLT is non-invasive and avoids the potential side effects of drug therapy. More specifically, LLLT delivers photons to targeted tissue, penetrating the layers of skin to reach internal tissues to produce a specific, nonthermal photochemical effect at the cellular level. Jeffrey R. Basford,
Laser Therapy: Scientific Basis and Clinical Role
, O
RTHOPEDICS
, May 1993, at 541. More specifically, the known effects of LLLT include enhancement of microcirculation and bone regeneration. J
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113, 133 (1999).
Known LLLT devices and methods involve the application of laser energy at a wavelength in the near to mid infrared range, under certain limited conditions which limit the dosage of laser energy being applied. Known LLLT devices and methods involve the limited application of laser energy with devices having a very low average power output well below 100 mW. Such devices require extended periods of time to deliver any given dosage to a treatment point. Especially when multiple points are being treated, and multiple treatments required, longer treatment times are a significant inconvenience for both technician and patient. Some LLLT methods involve the application of laser energy to limited, specified sites for specific reasons. For example, known LLLT methods for treating specific pain symptoms involve applying laser energy to specific, charted treatment points which are correlated with the specific pain symptoms. However, such methods are limited to the treatment of specific symptoms, do not identify specific laser energy dosages, and do not provide any guidelines for varying dosages for treatment of a range of tissue injuries.
Currently, methods for treating bone fractures, such as setting the bone and casting, are limited by the time course of the body's healing process. No known methods currently exist to accelerate the healing process itself. This is a particular problem for the elderly and others with fragile bones and slow healing processes. However, because of the enhancing effect of LLLT on microcirculation and bone regeneration, LLLT is likely to aid in the treatment of bone fracture by promoting the healing process.
It would therefore be desirable to provide an improved method for the treatment of bone fracture which promotes the healing process and thus reduces overall treatment time. It would also be desirable to provide such a method which is noninvasive, avoids the use of drug therapy, and is suitable for treating a wide range of patients and bone fractures. It would also be desirable to provide such a method which is relatively inexpensive to implement and convenient to use in conjunction with established standard of care orthopedic treatments for bone fractures.
BRIEF SUMMARY OF THE INVENTION
These and other objects may be attained by a method for treating bone fracture which in one embodiment includes applying low level laser energy to a treatment point on skin adjacent a bone fracture site. The method employs LLLT apparatus having a mean power output of about 100 mW to about 500 mW, and emitting laser energy at a wavelength in the visible to near-infrared range. Dosages per treatment point are from about 1 joule/point to about 10 joules/point, where a treatment point is defined as a spot having a diameter of about 1 cm.
To practice the method, an LLLT trained therapist, such as a clinician or physiotherapist, first determines a dosage within the above range, based on the type and severity of the fracture, and the patient's response to LLLT. The therapist then uses a handheld laser probe of the LLLT apparatus to first apply adequate pressure to blanch the skin at at least one treatment point on skin adjacent the fracture site. The LLLT apparatus is energized and low levels of laser energy are applied to the treatment point for a treatment time dependent on the mean power output of the LLLT apparatus and the dosage determined by the therapist. Total energy dose, number and location of treatment points, and number of treatments are determined by the treating physician.


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“Is Laser Therapy Overtaking Ultrasound?” http://www.laser.uk.com/laser, Therapy vs. ultrasoun.html, dated Feb. 20, 1999.
“Laser Therapy Introduction” http://laser.uk.com/physio.html, Mar. 4, 1999, 12 pgs.
“The use of low power lasers in sports medicine”, G.A. Gordon, Clinical Sports Medicine 2, 53-61 (1990).
Low Level Laser Therapy—Clinical Practice and Scientific Background, Jan Turner and Lars Hode, Prima Books in Sweden AB 1999, pp. 1-9; 45-58; 59-109; 113-116; 118; 132-134; and 151-156.

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