Surgery: light – thermal – and electrical application – Light – thermal – and electrical application – Light application
Reexamination Certificate
1999-07-01
2001-08-14
Dvorak, Linda C. M. (Department: 3739)
Surgery: light, thermal, and electrical application
Light, thermal, and electrical application
Light application
C606S009000, C606S013000, C128S898000
Reexamination Certificate
active
06273905
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
, ORTHOPEDICS, May 1993, at 541. In particular, LLLT appears to enhance the regeneration of neural tissue. JAN TUNER & LARS HODE, Low LEVEL LASER THERAPY: CLINICAL PRACTICE AND SCIENTIFIC BACKGROUND (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.
Curently, spinal cord transection is a devastating injury with no known curative treatment. Patients are more or less paralyzed depending on the spinal level of the transection. While some basic research has been done on regenerating spinal cord neurons in vitro, clinical progress has been slow. As a result, no known methods currently exist to repair spinal cord transection. Therefore, because of the beneficial effect of LLLT on neural regeneration, LLLT presents the basis of a promising new approach to the treatment of severe neural injuries such as spinal cord transection.
It would therefore be desirable to provide improved methods for the treatment of spinal cord transection. It would also be desirable to provide such a method which uses LLLT for its beneficial effect on neural regenartion. It would be further desirable to provide such a method which is relatively inexpensive to implement and easily practiced by trained surgeons.
BRIEF SUMMARY OF THE INVENTION
These and other objects may be attained by a method for treating spinal cord transection which in one embodiment includes the steps of culturing embyronal nerve cells in vitro, transplanting the cultured cells to a transected area of spinal cord, covering the area of transplantation with a fibrin-based membrane, closing the site, and locally applying LLLT to a treatment point on the skin adjacent the site of transection. In one embodiment, 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, up to and including about 30 joules/point, where one treatment point is spot having a diameter of about 1 cm.
In applying the LLLT, an LLLT trained therapist, such as a clinician or physiotherapist, first determines a dosage within the above range, based on the severity and location of the transection, 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 over the closed transection 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 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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Dvorak Linda C. M.
Kearney R.
Polster Lieder Woodruff & Lucchesi LC
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