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Injectable osteogenic formula and method of using sameRelated Patent Categories: Drug, Bio-affecting And Body Treating Compositions, Designated Organic Active Ingredient Containing (doai), Peptide Containing (e.g., Protein, Peptones, Fibrinogen, Etc.) Doai, Cyclopeptides, 25 Or More Peptide Repeating Units In Known Peptide Chain StructureInjectable osteogenic formula and method of using same description/claimsThe Patent Description & Claims data below is from USPTO Patent Application 20060293236, Injectable osteogenic formula and method of using same. Brief Patent Description - Full Patent Description - Patent Application Claims
CROSS REFERENCE TO RELATED APPLICATION [0001] This application claims priority of Provisional application Ser. No. 60/693,391 filed on Jun. 23, 2006, the disclosure of which is incorporated herein by reference. FIELD OF THE INVENTION [0002] This invention relates to growing bone in a site-specific location. BACKGROUND OF THE INVENTION [0003] The ability to grow bone at a site-specific location, in a minimally invasive manner, would have a profound impact on the health and quality of life for up to 50 million Americans who suffer bone defects and diseases. These diseases include post craniotomy resorption, periodontal disease, degenerative disk disease, osteoporosis, and aseptic osteolysis. Together, these diseases cost the United States Healthcare System in excess of $124 billion annually. [0004] Cranial [0005] Over 750,000 craniotomies are performed every year in the United States, to treat a variety of disorders including tumors, traumas, vascular lesions, seizures, decompression, cranioplasty, infections, intracranial cysts, and nerve decompression. Despite this, the skull has been one of the most difficult regions in which to use autograft techniques because of the cranium's propensity for resorption. Many materials and methods have been used including autologous bone grafts, metal plates (titanium, tantalum, stainless steel), hydroxyapatite cement, and methylmethaerylate, each with significant drawbacks. [0006] Periodontal Disease. [0007] The most common treatment for periodontal disease and tooth loosening is extraction and dental implantation or dentures. Over 20% of Americans, approximately 56 million people, have periodontal disease. Periodontal disease accounted for 10% of all dental costs in 1985. [0008] Spinal Disorders [0009] Spine disorder treatments are slowly trending toward minimally invasive techniques for penetrating past the muscle tissues surrounding the spine. Despite this, the solutions to degenerative disks (fusion, herniated disk repair and disk replacement) are still highly invasive procedures resulting in extensive surgical trauma and prolonged recovery times. Over 1 million spinal surgeries were performed last year and this number continues to rise. [0010] Joint Replacements [0011] Over 1/2 million knee and hip replacement surgeries are performed in the United States every year. The typical age of these patients is 65 years despite the fact that the average age of pain symptom onset is 40 years. The reason for this disparity is that the implants cause bone resorption at the interface, making their maximum useful life less than 15 years. [0012] Overall, the ability to induce rapid, localized bone growth would have a substantial beneficial effect in all the above conditions by reducing morbidity, hospitalization time, recovery time, and costs. The ability to grow bone at specific sites would also have a substantial positive impact on the treatment of bone fractures resulting from osteoporosis. It is estimated that over 24 million people suffer from osteoporosis, resulting in 3 million fractures per year in the United States. In 1995 osteoporotic fractures were estimated at $13.8 billion in direct medical expenses. TABLE-US-00001 Disorder Annual U.S. Cases Craniotomies 750,000 Periodontal Disease 28,000,000 Spinal Surgeries 1,000,000 Aseptic Osteolysis 500,000 Osteoporosis 3,000,000 Total 33,250,000 [0013] Bone Morphogenic Proteins (BMPs) are osteogenic compounds. However, BMPs can cause ectopic ossification, making them somewhat difficult and risky to use. SUMMARY OF THE INVENTION [0014] The invention comprises formulations and methodologies for treating degenerative bone conditions, bone fractures, and other bone-related conditions by combining an osteogenic compound with a delivery vehicle. The resulting combination may be injected or otherwise applied to (such as by an implant or other device, or by applying it to a site during surgery) a specific site, and cause bone growth at that site. [0015] This invention features an osteogenic formulation comprising an osteogenic compound and a delivery vehicle. The osteogenic compound is preferably prostaglandin (PGE), and may comprise PGE1 and/or PGE2. One reason that prostaglandins are the preferred osteogenic compounds for the invention is that they do not induce bone synthesis at ectopic sites by non-bone cells. [0016] The delivery vehicle may comprise a biodegradable matrix, which preferably comprises one or more polymers. Two preferred polymers are hyaluronic acid or a salt thereof, and/or a poly-glutamic acid. [0017] The invention also features a method of employing an osteogenic compound, comprising providing prostaglandin (PGE) osteogenic compound, providing a biodegradable polymer matrix delivery vehicle for the PGE, mixing the PGE and the delivery vehicle, and delivering the mixture to a site. The PGE may comprise PGE1 and/or PGE2. The polymer preferably comprises hyaluronic acid or a salt thereof, and/or a poly-glutamic acid. The delivery is preferably accomplished with a syringe, but as described above can be accomplished by other know means for site-specific delivery of a treatment vehicle. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS [0018] The following is a description of the preferred embodiments of the invention. The half-life of prostaglandin E1 (PGE1) is measured in minutes. PGE1 is rapidly metabolized in the lungs, therefore the delivery method is critical to widespread commercial use of PGE1 as an osteogenic compound. The invention is designed to stabilize and hold PGE1, which is by far the most potent osteogenic agent discovered to date, and deliver it via a gelatinous polymer matrix of hyaluronic acid, a material that is itself modestly osteogenic. PGE2 is less osteogenic than PGE1 but may still be useful in the invention. The matrix allows the osteogenic compound (preferably a prostaglandin) to make physical contact with the targeted bone surface, thus stimulating only the cells required for the healing process. The matrix releases the compound over a period of time so that the stimulation of the cells is maintained over a period of time until the process of osteogenesis is completed. Both the matrix and the compound are reabsorbed by the body. Because the material may be delivered by a syringe, more than one treatment can be readily accomplished. No surgical procedures are required. [0019] The delivery matrix is a biodegradable polymer The polymer should be gelatinous in nature and water soluble. This includes polymers such as carboxymethylcellulose, poly-glutamic acid (PGA), but preferably the polymer is hyaluronic acid. Hyaluronic acid is biocompatible and is itself mildly osteogenic. Continue reading about Injectable osteogenic formula and method of using same... Full patent description for Injectable osteogenic formula and method of using same Brief Patent Description - Full Patent Description - Patent Application Claims Click on the above for other options relating to this Injectable osteogenic formula and method of using same patent application. ###  How KEYWORD MONITOR works... a FREE service from FreshPatents1. Sign up (takes 30 seconds). 2. Fill in the keywords to be monitored. 3. Each week you receive an email with patent applications related to your keywords. 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