Surgery: light – thermal – and electrical application – Light – thermal – and electrical application – Light application
Reexamination Certificate
2001-06-29
2003-12-16
Dvorak, Linda C. M. (Department: 3739)
Surgery: light, thermal, and electrical application
Light, thermal, and electrical application
Light application
C607S090000, C607S091000, C606S003000, C606S009000, C128S898000
Reexamination Certificate
active
06663659
ABSTRACT:
FIELD OF THE INVENTION
The present invention relates to a method and apparatus for using a narrowband, multichromatic electromagnetic radiation emitter to photomodulating living tissue and, in particular, human cell-containing tissue. By exposing living tissue to electromagnetic radiation in carefully chosen wavelength-bands of the spectrum either continuously for a period of time or in pulses of a predetermined frequency, cells within living tissue can be stimulated to begin genetically determined routines or regenerative functions or inhibited from these same functions. The novel photomodulation apparatus and method can be used to control, stimulate, or inhibit cell growth to treat conditions caused by undesirable or suboptimal cell growth or cell function.
BACKGROUND OF THE INVENTION
It is traditionally accepted that the coherent nature of laser light (which is one of the properties that sets laser light apart form all other light) is necessary for the current applications of light sources used in medical treatment. This is particularly true for biostimulatory or bioinhibitory effects in living tissue since essentially all of the research is with lasers. Lasers, however, are very expensive devices, require large amounts of power, and can be extremely dangerous unless used under the strict supervision of qualified medical personnel. Further, lasers have long been believed to be essentially the only suitable source of electromagnetic radiation for generating effective biostimulatory or bioinhibitory effects because it was assumed that the light source must be monochromatic, that is of a single pure color or wavelength, i.e., is monchromatic—operating in a narrow spectrum of wavelengths. While other narrowband, multichromatic emissions sources have been known, such as laser diodes and, more generally, light emitting diodes (“LEDs”—devices capable of emitting electromagnetic radiation in a narrow spectrum of wavelengths), LEDs have never been widely accepted as suitable for use in medical treatment due to their limited power output and the low intensity of electromagnetic radiation they are capable of delivering to the living tissue receiving treatment. Moreover, despite the recent emergence of very high brightness LEDs, interest in the use of LEDs as a replacement for lasers in applications such as dermatological treatment, for example, has not become known within the art.
The lack of interest in using LEDs to replace lasers for medical treatment may be because most current lasers have very short pulse duration and also very high peak power. These are both properties that cannot be achieved by current LEDs and might never be. However, new lasers for treating unwanted hair and veins have more recently been developed that are ‘long pulsed’ and also use much lower peak power. As well, most biostimulatory experiments have used higher energies than those possible with LEDs. The thought of stringing hundreds or thousands of LEDs together has never been considered as it may have been considered to be an optical challenge for some applications.
Most laser technology applied for medical use is adapted from military laser technology and only more recently has the development of laser systems specifically created for medical use become commonplace, so LED systems that could be adapted for living tissue were not pre-existing like the lasers. Almost all laser research is directed at delivering the laser beam through mirror or fiber optics to living tissue. The maximum beam diameter is determined usually by the diameter of the lasing medium laser head. While it is commonplace to ‘narrow’ the beam diameter from that exiting the laser head, making the beam wider is rarely done as preserving the desired-required treatment parameters laser qualities becomes a significant optical issue and there is insufficient power to cover large areas with these parameters. Simply put, no one has been thinking of trying to cover say a square foot of surface with a laser beam, and currently a square inch is considered quite large for most medical applications. The concept of directly delivering the light from the LED directly to living tissue from the LED source itself is, therefore, contrary to laser design logic and the most likely reasoning why LEDs have never been thoroughly explored as an option for producing electromagnetic emissions for medical use.
Perhaps due to the belief that lasers are the only viable source of light applicable for use in medical treatment, or perhaps due to the belief that effective medical treatment required high energy light sources or high intensity pulsed sources (therefore leading to the widely accepted belief that lasers and similar high-intensity, monochromatic light sources are the only commercially useful sources of light), current clinical treatment regimens have been focused on applying enough energy to living tissue to heat the target molecules (i.e., water, blood, collagen, etc) therein above the minimum threshold needed to produce thermal injury. Thermal injury then occurs prior to wound healing—the phase in which skin begins to repair and regenerate by the formation, among many other things, new collagen fibers. For example, many laser-based treatments cause thermal injury that is believed to have a stimulatory effect by releasing chemicals which signal that the body has been wounded or injured and thus initiates a well defined sequence of events collectively termed wound healing. The end result of the wound healing mechanism may be the production of new collagen, but this occurs as a result of lethal or significant non-lethal damage to many types of cells. In contrast, through direct photoactivation (rather than a treatment regimen in which photothermal injury occurs) the direct bioactivation of a specific cell or subcellular component is triggered without appreciable levels of thermal injury or cell damage. Also, photoactivated biostimulation tends not to produce uncontrolled wound healing or abnormal wound healing (also termed scarring) as can all thermal events. Finally, there is another even higher level of thermal injury that causes protein denaturation and cell destruction and cell death. Such treatments can cause significant patient pain or discomfort and require lengthy recovery times.
Lastly, even the lowest-power lasers available for medical treatment require the supervision of qualified medical personnel. Even low-power lasers can cause at least eye damage or some degree of tissue injuries; and most lasers used for medical treatment have a risk of serious electrical shock or death. None are classified as ‘Insignificant Risk Devices’, a classification for devices (such as hair dryers, electric toothbrushes, etc.) which are deemed suitable for use without medical supervision due to the minimal risks of harm or injury they pose.
It would, therefore, be desirable to have a device, and a method of using such a device, that can provide the benefits of laser treatment at significantly reduced cost and power requirement while retaining the ability to deliver sufficient intensities of narrowband, multichromatic electromagnetic radiation to living tissue to induce biostimulatory or bioinhibitory effects as part of a regimen of medical treatment. Such a treatment regimen could provide significant dermatological benefits by the photoactivation of cells to induce skin rejuvenation (i.e., the generation of new collagen) without thermally injuring the skin.
It would also be advantageous to have a source of narrowband multichromatic electromagnetic radiation and a method of using such a device to make it capable of inducing beneficial biostimulatory or bioinhibitive effect without the need to heat the tissue above the level of thermal injury, thereby essentially eliminating patient pain, discomfort, and recovery time.
It would also be a significant advancement to the art to have a device and method of using such a device that can induce beneficial bioactivating or bioinhibiting effects in living tissue that does not require medical supervision or, in at least one embod
Dvorak Linda C. M.
Farah A.
LandOfFree
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