Device and method for laser biomodulation in PDT/surgery

Surgery – Instruments – Light application

Reexamination Certificate

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Details

C606S013000, C606S016000, C607S089000

Reexamination Certificate

active

06527764

ABSTRACT:

BACKGROUND OF THE INVENTION
1. Field of the Invention
The invention relates generally to medical laser treatments and more specifically to laser treatments performed in conjunction with simultaneous biomodulation effects: biostimulation and and/or biosuppression (and subsequent immunostimulation) such as cellular growth or repression.
2. Invention Disclosure Statement
Laser treatments such as laser surgery and Photodynamic Therapy (PDT) have gained acceptance in the medical community as competent and effective medical treatment modalities. Both treatments employ a high-power laser energy to effectuate the procedure. In comparison, low power laser energy can be used to elicit cellular responses helpful in promoting healing. These cellular responses and any practical applications they might provide have been undefined. The effect of low-power laser therapy appears to vary with wavelength and exposure time in an essentially unexplained manner.
It was recently discovered that the absorption of radiation by chromophores, light absorbing structures located within cells, can promote changes in that cell's energy production cycle. An increase in the cellular energy level will in turn result in cellular responses such as increased beneficial cell regeneration and growth. Conversely, a decrease in the cell's energy production cycle will have the opposite effect by decreasing regeneration and slowing growth.
Biostimulation systems for wound healing are known. For example, U.S. Pat. No. 4,612,604 describes a biostimulation system wherein a uniform beam of polarized light generated by a lamp is projected onto the treatment area, however, the invention is limited. First, the device employed to deliver the biostimulating energy is cumbersome. The device employs a lamp as the light source which projects its light through a lens and onto a projector (similar to an overhead projector device). In addition, the system is enclosed in a housing structure cooled by a fan. The overall size of the device makes it impractical for precise or mobile applications. Second, The light is emitted from a lamp and projected onto the treatment site. The application is therefore, broad and highly dependent on the distance the source is placed from the treatment site, thereby further cutting down on the system's mobility. Therefore, it follows that the system described provides only a broad biostimulating action.
U.S. Pat. No. 4,930,504 describes a biostimulation device that employs monochromatic radiation at a variety of wavelengths to stimulate healing in various tissues. The system however solely produces biostimulation effects, it does not provide for any coordinate treatment (one that causes cellular damage). Treatment is administered only after damage to the tissue has occurred. It is beneficial to be able to perform both coordinate treatments and biostimulation with a single device. The system described cannot accommodate such a variation and is therefore limited to its specific application.
Surgical laser systems contain visible aiming beams of several mW of power. Sometimes these aiming beams fall within a wavelength range suitable to be absorbed in one of the cell's major chromophores. However, any amount of biostimulation that is obtained by this aiming beam, is inadvertent, undetected and uncontrolled. Beneficial effects, if any, caused by this unscheduled exposure are accidental. Effective biostimulation requires that consistent power be employed in a regulated and controlled manner. No laser system exists which can administer the correct dosage of biostimulating laser power together with a component to apply the correct low-level laser power thoroughly over the required surface or tissue areas, to purposely complement a surgical and/or PDT application.
For example, U.S. Pat. No. 5,289,557 describes a medical laser system that employs a visible laser-aiming beam. The aiming beam is produced at a wavelength within the range of biostimulating light. However, any biostimulating effects caused by the aiming beam are inadvertent, unintended and uncontrolled. For effective biostimulation the wavelength of light used in the treatment must be carefully selected and the system must supply the correct irradiation dosage (dosage denoting power density and treatment time). Systems not employing these parameters will be both inconsistent and ineffective for and thus inapplicable to biostimulation.
A system that employs both an operating beam output as well as a ‘simultaneous’ biomodulating (comprised of either a biostimulating or a biosuppressing/immunostimulating action effecting cellular activity) low-power laser output would be beneficial. The system must be significantly versatile yet precise so that effective treatment can be administered.
BRIEF SUMMARY OF THE INVENTION
It is an aim of the present invention to provide a medical laser device and method for surgical or activating laser treatments that simultaneously incorporates a biomodulating component to ensure enhanced tissue healing and regeneration after treatment is administered.
It is another aim of the present invention to couple biomodulating laser energy delivery with photodynamic therapy to enhance tissue healing properties after treatment is administered.
It is a further aim of the present invention to couple biomodulating laser energy delivery with the activation of photosensitizers to enhance tissue healing properties after treatment is administered.
It is still another aim of the present invention to provide a method by which the laser system can be used effectively to apply surgical or activation laser power simultaneously with biomodulating power.
Briefly stated, the present invention provides a device and method for laser treatment that couples surgical or activating laser power with biomodulating power to enhance proper tissue healing and regeneration in conjunction with treatment. This treatment is achieved using an optical fiber system delivering laser power from two separate laser sources. One source provides laser energy at a power level and density suitable for the surgical or activation action desired. The second source produces laser power at a wavelength suitable for producing biomodulating effects in the treated tissue. Biomodulation treatment of the tissue promotes cellular healing and regeneration and ensures that proper healing occurs. In addition, the present invention describes a method by which the device is used for treatment. The main operating beam is applied to a site as the device is passed over the treatment area. During this treatment, the device also emits a biomodulating treatment beam onto the site over which the first beam has already passed. The device in this manner systematically performs a very high energy surgical or activation action and then applies immediately a healing action, enhancing the success of the treatment by ensuring that the treated tissue heals quickly and properly.
The above, and other objects, features and advantages of the present invention will become apparent from the following description read in conjunction with the accompanying drawings, in which like reference numbers in different drawings denote like items.


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