Device for the treatment of mucositis

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

Reexamination Certificate

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C607S089000

Reexamination Certificate

active

06796994

ABSTRACT:

BACKGROUND OF THE INVENTION
This invention relates to a device for the treatment of mucositis. The device includes arrays of optoelectronic devices, such as light emitting diodes, that emit radiation suitable for the treatment of mucositis.
Mucositis is a common complication of chemotherapy and radiation therapy. Because many chemotherapeutic drugs, as well as radiation therapy, kill all rapidly dividing cells indiscriminately, the mucosal linings of the mouth and gastrointestinal tract are often damaged during the treatment. As a result of these gastrointestinal effects, patients often develop ulcers in their mouths (i.e., oral mucositis) and suffer from nausea and diarrhea. Oral mucositis is a significant risk for patients as it can impair the ability to eat and drink and poses a risk for infection. Often times the severity of oral mucositis causes the chemotherapy and radiation therapy to be terminated or severely limited.
One method of treating mucositis is hyperbaric-oxygen therapy. Hyperbaric-oxygen therapy is currently the standard of care for ischemic, hypoxic, infected, and otherwise slowly-healing problem wounds, such as the ulcers that result from oral mucositis. Hyperbaric-oxygen therapy increases cellular activities, such as collagen production and angiogenesis, leading to an increased rate of healing. Hyperbaric-oxygen therapy involves treatment sessions of approximately 90 minutes in a confined, high-pressure chamber.
Hyperbaric-oxygen therapy has several disadvantages. For example, there are instances in which a patient who may benefit from hyperbaric oxygen is unable or unwilling to be treated in a high-pressure chamber. These situations include lack of access to a facility equipped with hyperbaric oxygen, claustrophobia, and certain chronic medical conditions which would make hyperbaric-oxygen therapy contraindicated. In addition, the long duration of the hyperbaric-oxygen therapy makes its use problematic, especially for young children.
Another method of treating mucositis is photodynamic therapy (PDT) or biostimulation using monochromatic light. Biostimulation is a method of using monochromatic light to deliver photons to cytochromes in the mitochondria of cells. Cytochromes are light-sensitive organelles that act as an electron transport chain, converting energy derived from the oxidation of glucose into adenosine triphosphate (ATP)—the mitochondria's fuel. By directly stimulating cytochromes with monochromatic light, it is believed that more fuel is pumped into the mitochondria of cells, increasing the energy available to the cells. Increasing the energy available to the cell is believed to ultimately speed up healing.
By pumping more fuel into the mitochondria, biostimulation is believed to increase the respiratory metabolism of many types of cells. The monochromatic light provided by biostimulation is believed to be absorbed by the mitochondria of many types of cells where it stimulates energy metabolism in muscle and bone, as well as skin and subcutaneous tissue. Specifically, biostimulation is believed to result in fibroblast proliferation, attachment and synthesis of collagen, procollagen synthesis, macrophage stimulation, a greater rate of extracellular matrix production, and growth factor production. Specifically, the growth factors that are produced include keratinocyte growth factor (KGF), transforming growth factor (TGF), and platelet-derived growth factor (PDGF).
One method of providing biostimulation is the use of lasers. Lasers can provide monochromatic light for the stimulation of tissues resulting in increased cellular activity during the healing process. Specifically, these activities are believed to include fibroblast proliferation, growth factor synthesis, collagen production, and angiogenesis.
Using lasers to provide monochromatic light for biostimulation has several disadvantages. First, lasers are limited by their wavelength capabilities. Specifically, the combined wavelengths of light optimal for wound healing cannot be efficiently produced, because laser conversion to near-infrared wavelengths is inherently costly. Second, lasers are limited by their beam width. A limited beam width results in limitations in the size of the wounds which may be treated by lasers. Third, and most importantly, along with the production of monochromatic light, lasers produce a significant amount of heat. As a result of the production of heat, lasers cannot be used for extended treatment times or in applications in which the patient cannot tolerate heat.
SUMMARY OF THE INVENTION
The invention provides a device for treating a medical condition, such as mucositis, using an array of optoelectronic devices, such as light-emitting diodes (LEDs), to produce a uniform emission of monochromatic light with the production of a minimal amount of heat.
In one embodiment of the present invention, a device for treating mucositis includes a housing positioned adjacent to a patient and a plurality of optoelectronic devices positioned within the housing. The optoelectronic devices, such as LEDs, emit radiation suitable for the treatment of mucositis while emitting a minimal amount of heat. The device also includes a cooling system that cools the optoelectronic devices.
In another embodiment of the present invention, a device for treating a medical condition, such as mucositis, includes a gantry suitable for accommodating a patient, a housing positioned adjacent the gantry, and a track coupled to at least one of the gantry and the housing. An array of optoelectronic devices, such as LEDs, is coupled to the housing. The optoelectronic devices emit radiation suitable for treating a medical condition while emitting a minimal amount of heat. A cooling system cools the array of optoelectronic devices. At least one of the gantry and the housing moves along the track changing the relative position between the gantry and the housing so that the radiation emitted by the optoelectronic devices is directed towards the patient.
In still another embodiment of the present invention, a device for treating a medical condition includes a first housing unit and a second housing unit. A first array of optoelectronic devices is positioned within the first housing unit and a second array of optoelectronic devices is positioned within the second housing unit. The optoelectronic devices emit radiation suitable for treating a medical condition while emitting a minimal amount of heat. The first and second housing units are positioned adjacent to the patient, so that the radiation emitted from the optoelectronic devices substantially encircles the patient.
In still another embodiment of the present invention, the device for treating mucositis includes a plurality of modules. Each module includes at least one electrically and thermally conductive lead frame substrate having an upper surface and being adapted to act as a heat sink. Each module also includes at least one optoelectronic device electrically connected to the upper surface of the lead frame substrate. The optoelectronic devices emit radiation suitable for treating a medical condition while emitting a minimal amount of heat. Each module also includes at least one connector that is adapted to interconnect the module with at least one other module. The modules interconnect to form an array, and the array is positioned adjacent to the patient so that the radiation emitted by the optoelectronic devices is absorbed by the patient.
It is a feature and advantage of the invention to provide a device for treating a medical condition, such as mucositis, that produces long-wavelength, broad-spectrum, near-infrared light, enabling both deeper and wider penetrations than laser light.
It is another feature and advantage of the invention to provide a device for treating a medical condition that produces multiple wavelengths, and is arranged in large, flat arrays so as to address large, three-dimensional surfaces.
It is still another feature and advantage of the invention to provide a device for treating a medical condition that provides uniform, e

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