Drug – bio-affecting and body treating compositions – Preparations characterized by special physical form – Particulate form
Reexamination Certificate
2000-04-27
2004-06-29
Pak, John (Department: 1616)
Drug, bio-affecting and body treating compositions
Preparations characterized by special physical form
Particulate form
C424S400000, C424S401000, C424S402000, C424S404000, C424S405000, C424S443000, C424S445000, C424S446000, C424S447000, C424S484000, C424S601000, C424S602000, C424S606000, C424S657000, C424S660000, C424S675000, C424S688000, C424S692000, C424S722000, C424S724000, C424SDIG001, C514S829000, C514S830000, C514S831000, C514S859000, C514S861000, C514S862000, C514S863000, C514S864000, C514S886000, C514S887000, C514S951000, C514S965000
Reexamination Certificate
active
06756060
ABSTRACT:
FIELD OF THE INVENTION
The present invention relates to bioactive glass-containing compositions, aqueous extracts derived from such compositions, cosmetics including these compositions, implants including the compositions, and methods of using the compositions to accelerate healing, reduce inflammation and reduce bacterial infection. More specifically, the present invention relates to compositions including particles of bioactive glass, optionally including one or more agents which aid in the delivery and distribution of the particles and which may also have other therapeutic effects, and methods of use thereof.
BACKGROUND OF THE INVENTION
When an injury occurs, cell damage initially comes from the precipitating event, such as a cut, resulting in ruptured cells and severed or crushed capillaries and other blood vessels. However, later damage can occur due to bacterial growth or to an inflammatory response.
The healing process involves several steps, including coagulation, inflammation, repair (or fibroplasia) of the damaged tissue, angiogenesis (or revascularization), re-epithelialization and remodeling. Several of these steps, while necessary to promote normal healing, can cause excessive scarring and other health related problems if unchecked.
For example, unchecked inflammation can have harmful consequences. For example, many chronic and even life-threatening disorders, such as asthma, rheumatoid arthritis, lung fibrosis, peritoneal adhesions, hypersensitivity and autoimmune diseases are a result of an uncontrolled inflammatory response. An unresolved inflammation in the lung resulting from bacterial infection (i.e., pneumonia) may eventually lead to extensive tissue damage and a chronic lung abscess. Inflammation of the peritoneal cavity and the resulting adhesions following abdominal surgery is a major cause of infertility in women. Asthma is an often life-threatening disorder which results from an inadvertently stimulated inflammatory response in the lungs.
An excessive inflammatory response can cause extensive swelling, which can lead to additional injury as a result of anoxia. Pain results from a combination of kinins and the effect of lysozymes and pressure from the swelling on nerve endings. Unchecked, the inflammatory response can set off a neural feedback loop and cause hyperalgesia, a phenomenon in which the surrounding area of injury remains painful. Accordingly, there is a great interest in the medical community to develop anti-inflammatory agents.
The amount of bacterial burden in a wound bed is an important factor in the healing of wounds, especially dermal ulcers. Some bacterial colonization is inevitable, and may even be beneficial in stimulating the body's natural immune response. However, excessive bacterial colonization is clearly detrimental and can lead to high levels of bacterial waste products, chronic inflammation, heavy exudate, increased tissue necrosis and eventually, full infection. Wounds typically will not heal when the bacterial burden is above about 10
5
microorganisms per gram of tissue.
Topical anti-microbial agents, including organism specific antibiotics such as bacitracin and silver sulfadiazine are typically used in wound care. However, these agents are generally regarded as relatively weak in action. More importantly, the recent rise of strains of microorganisms resistant to these agents has led to many intractable cases of infection. Other typically used antimicrobial agents, such as iodine and alcohol, damage native tissue and repair cells, and retard the healing process of dermal wounds.
Many treatments have been proposed for treating wounds and accelerating wound healing. Often, such treatments involve the use of growth factors, such as platelet derived growth factor (PDGF) or the use of cultured cells derived from the wounded patient's own skin. These methods are limited by the difficulty of preparing the growth factors, the time spent in preparing the cell cultures, and the high costs of such treatments. Further, potential side effects associated with such therapies are unknown at this time. For example, the prolonged use of corticosteroids is associated with untoward secondary effects.
It would be advantageous to provide compositions and methods for treating wounds, and, in particular, for treating bacterial infection and inflammatory response in patients. The present invention provides such compositions and methods.
SUMMARY OF THE INVENTION
Compositions and methods for treating wounds to significantly reduce the healing time and prevent the body's natural defenses from proceeding unchecked are disclosed. The compositions and methods allow wounds to heal in significantly less time than would otherwise occur. Inflammation is greatly reduced around the wound site. The incidence of scar formation following a wound or burn is reduced. The presence of bacteria is also reduced. The success of skin grafts is increased.
The compositions include non-interlinked particles of bioactive glass, alone or in combination with an additional anti-bacterial and/or anti-inflammatory agent, and optionally include other therapeutic agents. Formulations including the compositions, alone or in combination with a suitable carrier, preferably for topical administration, are also disclosed. Also disclosed are anti-bacterial solutions derived from bioactive glass, and methods of preparation and use thereof.
The compositions can be incorporated into implanted materials, such as prosthetic implants, sutures, stents, screws, plates, tubes, and the like, to impart anti-bacterial and anti-inflammatory properties to the materials. Anti-bacterial properties can also be imparted to devices used for in vitro and ex vivo cell culture by incorporating the composition into the devices.
Anti-bacterial and anti-inflammatory compositions derived from aqueous extracts of bioactive glass can be formed by placing bioactive glass in an aqueous solution, allowing the glass to dissolve over a suitable period of time, for example, a week or more, and filtering out the undissolved glass particles. The solvent can also be evaporated to provide a solid material with anti-bacterial properties. These compositions can be used in situations where prevention or reduction of bacterial infections would be advantageous, for example, food preparation, cosmetics, media used for cell culture, and buffer solutions.
When used topically to treat a wound or burn, the wound or burn is contacted with an effective amount of the composition for the intended application. When used for skin grafting, the bioactive glass-containing composition is applied to either the graft site prior to placing the donor tissue, or to the donor tissue itself.
The compositions can be administered to the pulmonary system, for example, via an inhaler, as an adjunct therapy for treating pneumonia or chronic sinus infections. The compositions can also be co-administered to the pulmonary system with therapeutic agents which are themselves inflammatory, to minimize the inflammatory response to these agents. The compositions can be applied directly to a surgical site to minimize post-surgical adhesions, minimize inflammation around the site, and prevent or minimize infection at the site. In one embodiment, the compositions are included in a polymeric material, preferably a biodegradable polymeric material, which is then applied to a surgical site to minimize post-surgical adhesions.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
Compositions and methods for treating wounds to significantly reduce the healing time and prevent the body's natural defenses from proceeding unchecked are disclosed. The compositions and methods allow wounds to heal in significantly less time than would otherwise occur. Inflammation is greatly reduced around the wound site. The incidence of scar formation following a wound or burn is reduced. The presence of bacteria is also reduced. The success of skin grafts is increased.
The compositions include non-interlinked particles of bioactive glass, alone or in combination with an
Diamond Mason
Greenspan David C.
Lee Sean
Meyers James L.
West Jon K.
Burns Doane Swecker & Mathis L.L.P.
Pak John
USBiomaterials Corp.
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