Method for improving cardiac microcirculation

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

Reexamination Certificate

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C606S003000, C128S898000

Reexamination Certificate

active

06214035

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. More specifically, one known effect of LLLT is to enhance microcirculation of both blood and lymph. JAN TUNER & LARS HODE, LOW LEVEL LASER THERAPY: CLINICAL PRACTICE AND SCIENTIFIC BACKGROUND 133 (1999).
Currently, the post-surgical recovery of cardiac patients is frequently complicated by reperfusion injury. Reperfusion injury results when myocardium the cardiac procedure. Reperfusion injury results when myocardium which has been rendered hypoxic due to disease is suddenly re-exposed to a healthy supply of oxygenated blood. Under such conditions, endothelial cells activate to release noxious inflammatory products such as leukocyte adhesive molecules, procoagulation factors and vasoconstrictive agents. These products of inflammation cause tissue local tissue damage, thus producing poorer patient outcomes post-surgery. No known methods currently exist to address the problem by directly enhancing microcirculation of the cardiac muscle. Because of the enhancing effect of LLLT on microcirculation, LLLT is likely to aid in the prevention of reperfusion injury by improving the delivery of oxygen, clearing noxious inflammatory products and promoting the healing process.
It would therefore be desirable to provide an LLLT method for reducing the risk of reperfusion injury after cardiac surgical procedures. It would also be desirable to provide such a method which is easily used in conjunction with cardiac surgery. It would also be desirable to provide such a method which is relatively inexpensive to implement and convenient to use.
BRIEF SUMMARY OF THE INVENTION
These and other objects may be attained by a method for improving cardiac microcirculation which in one embodiment includes the step of applying LLLT to areas of, and areas surrounding, ischemic myocardium after cardiac surgery. The application of LLLT increases local myocardial microcirculation and thus reduces the risk of reperfusion injury. 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 of about 630 nm to about 904 nm. Dosages per treatment point are from about 1 joule/point to about 10 joules/point, where a point is defined as a spot having a diameter of about 1 cm.
The method is practiced immediately post-procedurally, before closing the surgical incision. 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 size of the region of ischemic myocardium, the severity of ischemia, and the tissue response to LLLT. The therapist or surgeon then uses a sterilized, handheld laser probe of the LLLT apparatus to apply adequate pressure to maintain contact between the myocardium at treatment points in and around the region of ischemia, and the probe at the point where the probe emits the laser energy. The LLLT apparatus is energized and low levels of laser energy are applied to a treatment point for a treatment time determined by the therapist, or automatically by the LLLT apparatus. Total energy dose, number and location of treatment points, and number of treatments are determined by the treating physician.
Thus, the LLLT method provides a method for the prevention of cardiac reperfusion injury. In addition, the LLLT method is noninvasive, and simple to practice. Further, the LLLT method is relatively inexpensive to implement and convenient to use in conjunction with a range of cardiac surgeries, including coronary bypass surgeries and angioplasty.


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