Abstract: The invention concerns a system for biocompatible drug release comprising: (i) a polymer matrix; (ii) an inorganic component located inside said matrix and characterized by a lamellar structure with a net positive or negative charge able to intercalate (iii) a pharmacologically active principle into said lamellar structure, by establishing an ionic type of bond with it and thereby obtaining an intercalation compound. The preparation process for the release system comprises the stages of: treating the lamellar solid in such a way as to give it a net positive or negative charge, then combining it with the chosen active principle, also in an ionic form, to obtain an intercalation compound which is then mixed with the polymer matrix. The release system can be employed in making medical devices, like sutures, membranes, osteosynthesis plaques, multilayered devices, gels and drug delivery systems.

Abstract: Disclosed herein are improved osteogenic devices and methods of use thereof for repair of bone and cartilage defects. The devices and methods promote accelerated formation of repair tissue with enhanced stability using less osteogenic protein than devices in the art. Defects susceptible to repair with the instant invention include, but are not limited to: critical size defects, non-critical size defects, non-union fractures, fractures, osteochondral defects, subchondral defects, and detects resulting from degenerative diseases such as osteochondritis dessicans.

Abstract: This invention relates to blends of high, optionally medium, and low molecular weight polyesters where at least the low molecular weight polyester is substituted with an acidic moiety, the biodegradation of the blends being controllable by selection of the mean molecular weigh of each fraction, the quantity of each fraction in the blend and the amount and pKa of the acidic moiety(ies).

Abstract: The present invention provides implants comprising a therapeutic drug and a polymer containing polylactic acid (PLA) and optionally polyglycolic acid (PGA). The present invention also provides methods of maintaining a therapeutic level of a drug in a subject, releasing a therapeutic drug at a substantially linear rate, and treating schizophrenia and other diseases and disorders, utilizing implants of the present invention.

Abstract: In some embodiments, a device (102) may include a mesh having at least one bioresorbable polymer coating. The coating may comprise at least one active agent which is eluted over time. The device (102) may at least partially cover at least a portion of an implanted transdermal medical device (100).

Abstract: A laminated, bioimplantable dural graft product is configured for use as both an onlay graft and a suturable graft. The dural graft product is sufficiently pliable so as to sufficiently conform to a curvature of a tissue surface to which it is applied, such as the curved surface of a meningeal membrane. The use of the graft product can have improved properties, including suture retention strength and fluid impermeability. To use the dural graft product as an implant to replace, reinforce or strengthen bodily tissue, or to act as an adhesion barrier, the dural graft is placed in contact with bodily tissue and conforms to the curvature of the bodily tissue. Sutures can be used to maintain the contact between the dural graft and the bodily tissue.

Abstract: A stand-alone film is derived at least in part from fatty acids. The stand-alone film can have anti-adhesive, anti-inflammatory, non-inflammatory, and wound healing properties, and can additionally include one or more therapeutic agents incorporated therein. Corresponding methods of making the stand-alone film include molding, casting, or otherwise applying a liquid or gel to a substrate, and curing or otherwise treating to form the stand-alone film. The resulting stand-alone film is bioabsorbable.

Abstract: This invention relates to methods for producing a composite bone graft material that can regenerate bony defects in the body. The invention further relates to methods that allow for the production of bioactive glass particles used in the composite that have been surface treated to allow for the production of a highly porous composite that can hold significant amounts of body fluid or other molecules that will aid in the regenerative process. The method of surface treatment allows for the manufacture of a suitable implantable composite while retaining the unique osteostimulative properties that are associated with bioactive glass particles.

Abstract: A tissue scaffold includes a first film having a plurality of cell openings and a second film adjacent the first film and having a plurality of cell openings larger than the cell openings of the first film. The cell openings of the first film interconnect with the cell openings of the second film to define pathways extending through the first and second films.

Abstract: Methods are provided for making freeze dried hydrogel and structures therefrom that may be introduced into a patient's body for medical applications. Precursor components are combined to initiate crosslinking. The combined precursor components are placed in a chilled tray, and allowed to crosslink to a desired level of complete crosslinking before and/or after being placed onto the tray. The partially crosslinked hydrogel is frozen and freeze dried. After freeze drying, the hydrogel is conditioned to substantially complete crosslinking, and formed into one or more structures, e.g., plugs, hemostatic, or other medical devices. For example, the hydrogel may be cut, machined, rolled, folded, compressed, and/or cored into that may be loaded into delivery devices that may be introduced into a body to implant or otherwise deliver the structures into the body, e.g., to seal a puncture or other passage through tissue.

Abstract: A method and apparatus for reducing or eliminating pain after surgical procedures related to mucosal tissue, including tonsillectomy, adenoidectomy, or other pharyngeal operations. Certain embodiments provide a biodegradable film or covering that serves as a mechanical barrier to reduce pain caused, for example, by friction between solid food and healing tissue in the first few days after surgery. Some embodiments may include one or more therapeutic substances for locally reducing pain, facilitating healing and/or otherwise treating mucosal tissue at or near a tonsil bed.

Abstract: A cell tissue gel containing collagen and hyaluronan at a weight ratio of 0.01-100:1 and uses thereof for stem cell delivery.

Abstract: The present invention provides biocompatible, biodegradable matrices formed from poly-?(1?4)glucopyranose and reactive hydrazide groups. The matrices can be used for various applications in the body, including drug delivery and cell therapy.

Abstract: This invention provides aragonite- and calcite-based scaffolds for the repair, regeneration, enhancement of formation or a combination thereof of cartilage and/or bone, which scaffolds comprise at least two phases, wherein each phase differs in terms of its chemical content, or structure, kits comprising the same, processes for producing solid aragonite or calcite scaffolds and methods of use thereof.

Abstract: A biodegradable biodelivery device is disclosed. The biodelivery device is formed from a polymer comprising the reaction product of a polyol and a polyacid. When exposed to water, the polymer degrades through hydrolysis. Of particular advantage, the polymer can be formed so as to be elastic and flexible. In one embodiment, the polymer is formed into a vaginal insert. As the polymer degrades, the polymer releases acid to a vaginal environment for decreasing the pH of the environment.

Abstract: The present invention is directed to stents made of a magnesium alloy degradable under physiological conditions and an outer polymeric coating. Herein, the stents according to the invention can be additionally coated with at least one anti-inflammatory, antiproliferative, antiangiogenic, antirestenotic and/or antithrombogenic active agent.

Abstract: Implants and methods for the delivery of a therapeutic agent to a target location within a patient's body are disclosed. The implants include a fiber comprising a polymeric material and having a diameter of up to about twenty microns, and a first therapeutic agent within the fiber. The therapeutic agent is substantially in particulate form. The implants are of a variety of configurations, such as individual fibers, yarns, ropes, tubes, and patches.

Abstract: The invention relates to a bone formation agent of porous calcium phosphate having an isotropic sintered structure and, between the particles of the calcium phosphate, statistically distributed pores in a plurality of discrete size ranges. The bone formation agent has at least two, preferably three, discrete pore size distributions. Its porosity has an irregular geometric shape. The sintered particles of the calcium phosphate have a particle size smaller than 63 ?m with a d50 value in the range from 5 to 20 ?m. The interconnecting pore share in the overall porosity is limited to pore sizes less than 10 ?m. The bone formation agent can be used in the form of a granulate or shaped body for bone regeneration. In the case of granulates, the maximum pore diameters are matched to the granulate diameter. The invention relates also to a method of producing the bone formation agent.

Abstract: The present invention relates to injectable compositions comprising biocompatible, hydrophilic, non-toxic and substantially spherical microspheres associated with stem cells useful for tissue construction and generation. The invention also relates to methods of tissue construction and generation, for the treatment of various tissue damage and defects, using the injectable compositions.

Abstract: The invention provides biodegradable implants sized for implantation in an ocular region and methods for treating medical conditions of the eye. The implants are formed from a mixture of hydrophilic end and hydrophobic end PLGA, and deliver active agents into an ocular region without a high burst release.

Abstract: The present invention relates in general to implantable flexible bone composites, and method for preparing the same. The flexible bone composite includes at least one polymeric layer and at least one calcium-containing layer. The polymeric layer can be a polymeric layer including a synthetic polymer. The calcium-containing layer can include a calcium compound such as ?-Ca3(PO4)2. The flexible bone composites of the invention are useful as bone void fillers and have improved handling characteristics.

Abstract: The invention relates to a medical implant made of a metallic material. After fulfilling its temporary support function, the implant is degraded by corrosion at a predetermined rate. Negative long-term effects are thus avoided.

Abstract: A bioabsorbable blend comprising poly(L-lactide) (PLLA) and a phosphorylcholine group-containing copolymer (PPCP) capable of enduring the mechanical strength of blood vessel walls and applicable for fabricating cardiovascular devices was developed. The blend acts as a scaffold to support blood vessel walls during vascular healing and undergoes biodegradation in vivo after vascular healing is complete. Furthermore, the blend can prevent the formation and adsorption of thrombi.

Abstract: The subject matter provided herein relates to method for inhibiting or mitigating scar formation in a wound of the skin, by increasing the concentration of SDF-1 in, or proximate to, the wound. As described herein SDF-1 protein or an SDF-1 expression vector can be administered to a wound or the area proximate a wound by providing a therapeutically effective amount of SDF-1 protein or an SDF-1 expression vector.

Abstract: The invention provides high molecular weight, crystalline or semi crystalline biodegradable and biocompatible poly(ester urea) (PEU) polymers useful for making vascular stents and hard tissue replacement implants, such as bone substitutes. The PEU polymers are based on ? amino acids and are made by a polycondensation reaction. PEU polymer compositions can contain a therapeutic diol incorporated into the polymer backbone that is released from such an implant in situ. Bioactive agents, such as analgesics, antibiotics, and the like, can also be covalently attached to certain PEU polymers for release into tissue surrounding an implant during biodegradation of the polymer.

Abstract: The present invention is directed to compositions having at least one neocartilage particle, juvenile cartilage particle or a combination thereof and a matrix, and methods and devices that include the compositions.

Abstract: In some embodiments, there are provided methods and compositions for treating, preventing, or delaying the onset of type 2 diabetes and related disorders. The methods comprise administering a sustained release composition comprising a peroxisome proliferator-activated receptor (PPAR) agonist subcutaneously in a localized area of the subject. Slow release of the PPAR agonist in situ enhances the metabolic activity of subcutaneous adipose tissue, resulting in an increased ability of the tissue to clear excess glucose and lipid from the blood stream, while minimizing adverse side-effects of the agonist.

Abstract: The present invention provides gradient porous scaffolds for bone regeneration and osteochondral defect repair, methods for making such gradient porous scaffolds, and methods for using the gradient porous scaffolds.

Abstract: The present invention provides a coating comprising a reservoir layer comprising a semi-crystalline polymer and a primer layer comprising an amorphous polymer on an implantable device and methods of making and using the same.

Abstract: Surgical implants are provided which include a film comprising a first therapeutic agent and a mesh comprising a second therapeutic agent. The surgical implant includes a film in direct contact with a mesh. The first therapeutic agent may be released at a first rate and the second therapeutic agent may be released at a second rate.

Abstract: Surgical implants are provided which include a film comprising a first therapeutic agent and a mesh comprising a second therapeutic agent. The surgical implant includes a film in direct contact with a mesh. The first therapeutic agent may be released at a first rate and the second therapeutic agent may be released at a second rate.

Abstract: A highly compression resistant matrix is provided for implantation at or near a target tissue site beneath the skin. The matrix comprises a polymer and a ceramic skeleton. The compression resistance provides retention of a volume that facilitates bone regeneration.

Abstract: Coatings for an implantable medical device and a method of fabricating thereof are disclosed, the coatings including block-polymers comprising at least one poly(hydroxyacid) or poly(hydroxy-alkanoate) block, at least one block of a biologically compatible polymer and at least one type of linking moiety.

Abstract: Surgical implants are provided which include a film comprising a first therapeutic agent and a mesh comprising a second therapeutic agent. The surgical implant includes a film in direct contact with a mesh. The first therapeutic agent may be released at a first rate and the second therapeutic agent may be released at a second rate.

Abstract: A cyclized peptide designated BMP Binding Peptide (BBP) is a synthetic peptide that avidly binds rhBMP-2. BBP increases the overall osteogenic activity of rhBMP-2, increases the rate at which rhBMP-2 induces bone formation, and BBP induces calcification alone. Compositions and substrates including BBP, and methods of using BBP are useful in therapeutic, diagnostic and clinical applications requiring calcification and osteogenesis.

Abstract: The present invention relates to novel anesthetic compositions containing a non-polymeric carrier material and an anesthetic, where the compositions are suitable for providing a sustained local anesthesia without an initial burst and having a duration for about 24 hours or longer. Certain compositions are also provided that include a first anesthetic and a second anesthetic. In such compositions, the second anesthetic is a solvent for the first anesthetic and provides an initial anesthetic effect upon administration to a subject. The non-polymeric carrier may optionally be a high viscosity liquid carrier material such as a suitable sugar ester. The compositions can further include one or more additional ingredients including active and inactive materials. Methods of using the compositions of the invention to produce a sustained anesthetic effect at a site in a subject are also provided. Preferably the composition contains bupivacaine and a sugar ester such as saib.

Abstract: A device including a body (12) including fibers without oxidized cellulose. The body (12) also includes fibers containing oxidized cellulose.

Abstract: The present invention provides an absorbable coating for an implantable device and the methods of making and using the same.

Abstract: Devices and methods for the treatment of open and closed wound spinal cord injuries are disclosed. For example, described herein are devices and methods for mitigating secondary injury to, and promoting recovery of, spinal cord primary injuries. More particularly, certain embodiments of the present invention are directed to polymeric mini-tubes that may be used for the treatment of spinal cord injuries. In addition, other embodiments are directed to polymeric “fill-in” bandages that may be used for the treatment of spinal cord injuries. For example, an erodible, or biodegradable, form of biocompatible polymer of the present invention is fabricated for surgical implantation into the site of the spinal cord injury.

Abstract: A method of fabricating an implantable medical device that includes deforming and heating setting a polymer construct, for use in fabricating the device, in a temperature range in which the crystal nucleation rate is greater than the crystal growth rate is disclosed.

Abstract: The invention provides a method for fabricating an implantable medical device to increase biocompatibility of the device, the method comprising: heat setting a polymer construct, wherein the polymer construct is at a temperature range of from about Tg to about 0.6(Tm?Tg)+Tg such that the set polymer construct comprises a crystalline structure having crystals at a size less than about 2 microns; and fabricating an implantable medical device from the heat set polymer construct.

Abstract: The present invention provides implants comprising a therapeutic drug and a polymer containing polylactic acid (PLA) and optionally polyglycolic acid (PGA). The present invention also provides methods of maintaining a therapeutic level of a drug in a subject, releasing a therapeutic drug at a substantially linear rate, and treating schizophrenia and other diseases and disorders, utilizing implants of the present invention.

Abstract: The present invention provides a nerve regeneration-inducing tube in which collagen having excellent adhesive property, cell growth property and differentiation inducing property to nerve cells is used as a scaffold for the nerve regeneration. The nerve regeneration-inducing tube is characterized in using the collagen which is made the concentration of sodium chloride contained therein not more than 2.0% by weight or, preferably, 0.1 to 1.5% by weight in a dry state. Purification of collagen is carried out by means of an isoelectric precipitation where the pH is 6.0 or higher and is lower than 10.0.

Abstract: A method for controlling generation of biologically desirable voids in a composition placed in proximity to bone or other tissue in a patient by selecting at least one water-soluble inorganic material having a desired particle size and solubility, and mixing the water-soluble inorganic material with at least one poorly-water-soluble or biodegradable matrix material. The matrix material, after it is mixed with the water-soluble inorganic material, is placed into the patient in proximity to tissue so that the water-soluble inorganic material dissolves at a predetermined rate to generate biologically desirable voids in the matrix material into which bone or other tissue can then grow.

Abstract: Biodegradable implants comprising dopamine modulating compounds are described.

Abstract: An implantable or insertable medical device is provided which contains the following: (a) a substrate, (b) a therapeutic agent-containable region disposed over the substrate, (c) a nanoporous polymeric layer disposed over the therapeutic agent-containable region and (d) a macroporous non-polymeric layer disposed over the nanoporous polymeric layer. The nanoporous polymeric layer largely regulates transport of species between the therapeutic agent-containable region and the exterior of the device. The macroporous non-polymeric layer has a larger pore size than the nanoporous polymeric layer and largely serves to isolate the polymeric material from surrounding tissue during in-situ delivery of the therapeutic agents.

Abstract: The present specification discloses tetrahydroindolone derivatives or analogues and methods for treating cognitive/attention deficit disorders using such tetrahydroindolone derivatives and analogues.

Abstract: A method for manufacturing a porous ceramic scaffold having an organic/inorganic hybrid coating layer containing a bioactive factor includes (a) forming a porous ceramic scaffold; (b) mixing a silica xerogel and a physiologically active organic substance in a volumetric ratio ranging from 30:70 to 90:10 and treating by a sol gel method to prepare an organic/inorganic hybrid composite solution; (c) adding a bioactive factor to the organic/inorganic hybrid composite solution and agitating until gelation occurs; and (d) coating the porous ceramic scaffold with the organic/inorganic composite containing the bioactive factor added thereto. In accordance with the method, the porous ceramic scaffold may be uniformly coated with the organic/inorganic hybrid composite while maintaining an open pore structure, and stably discharge the bioactive factor over a long period of time.

Abstract: Described is an implantable medical material comprising a malleable, cohesive, shape-retaining putty including mineral particles, insoluble collagen fibers and soluble collagen. The medical material can be used in conjunction with biologically active factors such as osteogenic proteins to treat bone or other tissue defects in patients.

Abstract: The development and growth of oviparous species such as birds is enhanced by in ovo administration of an enteric modulator such as HMB. The enteric modulator is administered into the amnion, where it is then orally ingested by the subject. The enteric modulator enhances the enteric development of the subject prior to hatch, and enhances the growth of the animal before and after hatch.