Abstract: The present invention relates to a method of implanting a sterile, active agent-coated material comprising contacting a sterile implant with a sterile active agent or active agent solution to form a sterile, active agent-coated implant and, at most a relatively short time after forming the active agent-loaded sterile implant, implanting the active agent-loaded sterile implant into a subject such as a mammal or a human.

Abstract: Glycerophosphate salts have been found to drastically improve a laparoscopic surgery by reducing the inflammatory response inflicted by the surgery and enhancing wound healing. Methods and devices for improving the laparoscopic surgery using a composition comprising an effective amount of a glycerophosphate salt are described.

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: 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: The invention is directed to compositions comprising decellularized bone marrow extracellular matrix and uses thereof. Methods for repairing or regenerating defective, diseased, damaged or ischemic tissues or organs in a subject, preferably a human, using the decellularized bone marrow extracellular matrix of the invention are also provided. The invention is further directed to a medical device, preferably a stent or an artificial heart, and biocompatible materials, preferably a tissue regeneration scaffold, comprising decellularized bone marrow extracellular matrix for implantation into a subject.

Abstract: Disclosed is a novel device for the vacuum infusion of a porous medical implant contained therein with one or more pharmaceutical substances and a method for the device's use. The device is deformable, and capable of adjusting to the outer contour of a porous medical implant to facilitate packaging, shipping and storage of the implant contained within the device. In addition, the device is unbreakable, easily disposed of after use, maintains the implant in a sterile condition before and after infusion and minimizes the quantity of pharmaceutical substance needed for infusion. Use of the device provides for rapid and complete infusion of a variety of pharmaceutical substances into a porous implant prior to surgery.

Abstract: Biodegradable coatings for implantable medical devices are disclosed.

Abstract: A rapid method for preparing stem cell and physiologically acceptable matrix compositions for use in tissue and organ repair is described. Compared with previous tissue engineering materials, the stem cell-matrix compositions of the present invention do not require long-term incubation or cultivation in vitro prior to use in in vivo applications. The stem cells can be from numerous sources and may be homogeneous, heterogeneous, autologous, and/or allogeneic in the matrix material. The stem cell-matrix compositions provide point of service utility for the practitioner, wherein the stem cells and matrix can be combined not long before use, thereby alleviating costly and lengthy manufacturing procedures. In addition, the stem cells offer unique structural properties to the matrix composition which improves outcome and healing after use. Use of stem cells obtained from muscle affords contractility to the matrix composition.

Abstract: A biodegradable therapeutic carrier and implant comprises a layer of biodegradable electrospun material and floored wells formed by the layer to contain therapeutic.

Abstract: The invention relates to coating of suppositories containing free unsaturated fatty acid, fatty acid ethyl ester and fatty acid monoglyceride that are susceptible to oxidative degradation. The coating retards oxidative degradation of unsaturated fatty acids and gives the suppository a non-oily and smooth surface. The coating will enhance the shelf-life of the suppository and allow their storage at room temperature for extended time period. The coating may or may not contain medicament such as local anesthetic or steroid. According to this invention chemically unstable fatty acids in coated suppositories can be used to stimulate the process of defecation or to treat disorders such as hemorrhoids, bacterial infections, viral infections and inflammations, as well as against fissura ani and pruritus ani. Furthermore, coating suppositories, that contain high concentrations of free fatty acids, can reduce acid induced rectal irritation.

Abstract: A degradable, removable, pharmaceutical implant for the sustained release of one or more drugs in a subject, wherein the pharmaceutical implant is composed of a tube comprising an outer wall made of a degradable polymer completely surrounding a cavity, wherein the outer wall has a plurality of openings and wherein the cavity contains one or more sets of micro-particles, which micro-particles contain an active agent or a combination of two or more active agents, and wherein the size of the microparticles is selected such that the majority of the microparticles cannot pass through the openings.

Abstract: The present disclosure relates to a chitosan solution neutralized with amino-sugar carbonate buffering solution or amino-sugar phosphate buffering solution or phosphorylated aminosugar buffering solution. The resulting thermogelling chitosan composition is highly biocompatible, isotonic and has the ability to rapidly turn into gel upon heating to the body temperature. It provides a novel chitosan-based composition to suitable for drug delivery, cell delivery and repair or regeneration of tissues and organs as well as other clinical treatment.

Abstract: Methods and products are provided for treating a wound or infection in a mammal or disinfecting a surface with a hypochlorous acid solution that has been activated by a catalyst. Additionally provided is a process for preparing an antimicrobial product that produces an activated hypochlorous acid solution for use as an antimicrobial.

Abstract: A biobeneficial coating composition for coating an implantable device, such as a drug eluting stent, a method of coating the device with the composition, an implantable device coated with the composition, and a method of treating a disorder are provided.

Abstract: Medical devices that are resistant to biofilm development and methods of the manufacture of biofilm resistant medical devices are provided. One or more bacteriophages are tethered to the surface of a medical device or a hydrogen-type coating on the surface of the device by covalent bonding while maintaining bacteriophage infective or lytic activity. The presence of the bacteriophages on a medical device, such as an indwelling medical device, prevents biofilm formation or reduces existing biofilm formation on the surface of the device when in use. These devices address the long felt need for biofilm resistant devices that increase safety and reduce complications normally associated with prior indwelling or other medical devices.

Abstract: The invention relates to inhibitory anti-factor XII/FXIIa antibodies and methods of their use.

Abstract: The present invention provides a ceramic porous body for in-vitro and in-vivo use comprising a composition comprising a calcium aluminate (CA) containing phase and optionally at least one of an accelerator, a retarder, a surfactant, a foaming agent, a reactive alumina, water, a fiber, and a biologically active material, and combinations thereof. Ceramic compositions are provides as well as method of using the ceramic compositions and methods of manufacturing a ceramic porous body. The ceramic porous bodies of this invention may be used as artificial bones, joints, in-vitro support structures, and in-vivo support structures for cells, tissues, organs, and nerve growth and regeneration.

Abstract: A system for growing tissue based upon layers of an inorganic extracellular matrix, wherein each layer of the inorganic matrix is designed to dissolve at a separate rate and result in sequential growth factor delivery upon its dissolution.

Abstract: A stable, controlled release formulation for oral dosing of vitamin D compounds is disclosed. The formulation is prepared by incorporating one or more vitamin D compounds into a solid or semi-solid mixture of waxy materials. Oral dosage forms can be prepared by melt-blending the components described herein and filling gelatin capsules with the formulation.

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: Methods for applying injectable fillers are provided. In some embodiments, the methods can extend effectiveness of the injectable filler. In some embodiments, the methods can provide for an elevated level of effectiveness of the injectable filler. In some embodiments, the methods can prolong the effectiveness of the injectable filler.

Abstract: Materials and methods are disclosed for controlling vasculogenesis using building blocks of a collagen matrix and endothelial colony forming cells (ECFC). The building blocks may be isolated by fractionating an acid soluble Type I collagen. The building blocks comprising monomers and/or oligomers may be recombined in desired ratios to alter the matrix microenvironment and to influence ECFC behavior.

Abstract: Embodiments of the disclosure include lubricious coatings. In an embodiment the disclosure includes a lubricious coating for a medical device including first and second coated layers. The first coated layer is between the second coated layer and the device surface and includes a vinyl pyrrolidone polymer and a photo reactive group. The second coated layer is in direct contact with the first coated layer and is a top coating that includes an acrylic acid polymer. The second coated layer can optionally include photoreactive groups. The coating was found to have a very low number of particulates (e.g., 10 ?m or greater) which is very desirable for in vivo use.

Abstract: Polyhydroxyalkanoates (PHAs) from which pyrogen has been removed are provided. PHAs which have been chemically modified to enhance physical and/or chemical properties, for targeting or to modify biodegradability or clearance by the reticuloendothelial system (RES), are described. Methods for depyrogenating PHA polymers prepared by bacterial fermentation processes are also provided, wherein pyrogens are removed from the polymers without adversely impacting the polymers' inherent chemical structures and physical properties. PHAs with advantageous processing characteristics, including low melting points and/or solubility in non-toxic solvents, are also described. The PHAs are suitable for use in in vivo applications such as in tissue coatings, stents, sutures, tubing, bone, other prostheses, bone or tissue cements, tissue regeneration devices, wound dressings, drug delivery, and for diagnostic and prophylactic uses.

Abstract: A method for repairing or replacing damaged tissue, or for providing post-surgical augmentation, comprising administering a pliable biocompatible material and a physiologically acceptable suspending agent to a patient is disclosed. Copolymers of unsubstituted acrylate and substituted acrylate are disclosed as pliable biocompatible materials.

Abstract: The technology described herein is directed to methods and devices that can be used to induce functional organ structures to form within an implantation device by implanting it in vivo within the body of a living animal, and allowing cells and tissues to impregnate the implantation device and establish normal microenvironmental architecture and tissue-tissue interfaces. Then the contained cells and tissues can be surgically removed intact and either transplanted into another animal or maintained ex vivo by perfusing it through one or more of the fluid channels with medium and/or gases necessary for cell survival.

Abstract: The present invention relates to a preparation method for core-shell structured fibrous scaffolds, and more specifically to preparing a core part composition and a shell part composition that each have different constitutions by adding calcium phosphate cement and a protein, drug of combination thereof to alginate solution, and then inserting the above core part composition and shell part composition to internal and external nozzle of concentric nozzle respectively to inject into calcium ion aqueous solution and thereby hardening them, thus preparing core-shell structured rapidly setting Alg/?-TCP scaffolds capable of controllably releasing a protein or drug.

Abstract: A polymer composition including a polymer having a hydroxyl group and a histidine or a histidine derivative grafted to the polymer having a hydroxyl group. A polymer material is also provided, including a polymer composition which includes a polymer having a hydroxyl group, and a histidine or a histidine derivative grafted to the polymer having a hydroxyl group.

Abstract: The current invention relates to poly(amide) and poly(ester-amide) polymers, coatings including the polymers, and narrow polydispersity drug delivery particles including the polymers.

Abstract: In one aspect, the present invention provides composite coatings for implantable or insertable medical devices. These composite coatings comprise (a) an inorganic portion and (b) a polymeric portion that comprises a poly(vinyl pyrrolidone) (PVP) block.

Abstract: The invention relates to novel monomers of Formula (I) useful for preparation of phase-separated biocompatible polymers or polymer compositions. These polymers or polymer compositions may be bioresorbable and/or biodegradable and have desirable mechanical properties, such as fracture and/or fatigue toughness, which have not been a primary design criteria for such polymers previously. The polymers or polymer compositions are useful in a variety of medical applications, such as in the fabrication of medical devices. Therefore, methods for preparing these polymers or polymer compositions and medical devices are also encompassed by this disclosure.

Abstract: Described herein are compositions comprising decellularized extracellular matrix derived from skeletal muscle or other suitable tissue, and therapeutic uses thereof. Methods for treating, repairing or regenerating defective, diseased, damage, ischemic, ulcer cells, tissues or organs in a subject preferably a human, with diseases, such as PAD and CLI, using a decellularized extracellular matrix of the invention are provided. Methods of preparing culture surfaces and culturing cells with absorbed decellularized extracellular matrix are provided.

Abstract: The present disclosure describes methods of treating angiogenic disorders of the eye, such as macular degeneration, restenosis following glaucoma treatment or diabetic retinopathy, by administering an activator of CXCR3. In some embodiments, the activator of CXCR3 is IP-10 or a fragment or variant thereof, such as a fragment comprising or consisting of the C-terminal ?-helix of IP-10. In other embodiments, the activator of CXCR3 is PF4 or a fragment or variant thereof.

Abstract: Methods for restoring normal patterns of activity in a subject suffering from Parkinson's Disease are disclosed that include administering an effective steady state concentration of a dopamine modulating compound continuously for a prolonged period of time such that normal patterns of activity are substantially restored in the subject.

Abstract: A continuous device for culturing mammalian cells in a three-dimensional structure for the transplantation or implantation in vivo is described. The culturing device comprises (a) a scaffold formed by a matrix of interconnected growth surfaces spaced at regular intervals and (b) a fluid distribution means at the inlet and the exit of the growth areas. The device is particularly useful for culturing bone cells for dental implants or bone reconstruction.

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: The present invention is directed to a novel poly(diol citrates)-based coating for implantable devices. More specifically, the specification describes methods and compositions for making and using implantable devices coated with citric acid copolymers or citric acid copolymers impregnated with therapeutic compositions and/or cells.

Abstract: The present invention is a natural, cell-free tissue replacement that does not require difficult or extensive preparation made by washing tissue replacement in a solution including one or more sulfobetaines and an anionic surface-active detergent and washing the tissue replacement in serial solutions of the buffered salt to remove excess detergent. The natural, cell-free tissue replacement may be a nerve graft that supports axonal regeneration, guides the axons toward the distal nerve end and/or is immunologically tolerated. Other forms of the invention are a composition and kit prepared by the method of making a native, cell-free tissue replacement. The present invention may be modified for use in diagnostic, therapeutic, and prophylactic applications.

Abstract: Osteoinductive compositions and implants having increased biological activities, and methods for their production, are provided. The biological activities that may be increased include, but are not limited to, bone forming; bone healing; osteoinductive activity, osteogenic activity, chondrogenic activity, wound healing activity, neurogenic activity, contraction-inducing activity, mitosis-inducing activity, differentiation-inducing activity, chemotactic activity, angiogenic or vasculogenic activity, and exocytosis or endocytosis-inducing activity. In one embodiment, a method for producing an osteoinductive composition comprises providing partially demineralized bone, treating the partially demineralized bone to disrupt the collagen structure of the bone, and optionally providing a tissue-derived extract and adding the tissue-derived extract to the partially demineralized bone.

Abstract: An intravascular stent has a coating comprising a crosslinked amphiphilic polymer and a sparingly water soluble matrix metalloproteinase inhibitor (MMPI). Preferably the polymer is formed from 2-methacryloyloxy-2?-ethyltrimethylammonium phosphate inner salt, C4-18 alkyl methacrylate and reactive and/or crosslinking monomer and the MMPI is a hydroxamic acid, more preferably batimastat. Preclinical and clinical results are reported, showing good luminal areas and reduced intimal thickening.

Abstract: Thermoplastic elastomer compositions are described comprising multigraft copolymers. The multigraft copolymers can comprise a rubbery polymeric backbone and a plurality of glassy polymeric side chains, each attached at one of a plurality of branch points randomly spaced along the backbone. The copolymer materials have high tensile strength, high strain at break, and low residual strain after elongation. The compositions can be used as adhesives and in a wide variety of high tech, medical, and commodity applications.

Abstract: Embodiments of the present invention provide Dermal Micro-organs (DMOs), methods and apparatuses for producing the same. Some embodiments of the invention provide a DMO including a plurality of dermal components, which substantially retain the micro-architecture and three dimensional structure of the dermal tissue from which they are derived, having dimensions selected so as to allow passive diffusion of adequate nutrients and gases to cells of the DMO and diffusion of cellular waste out of the cells. Some embodiments of the invention provide methods and apparatuses for harvesting the DMO. An apparatus for harvesting the DMO may include, according to some exemplary embodiments, a support configuration to support a skin-related tissue structure from which the DMO is to be harvested, and a cutting tool able to separate the DMO from the skin-related tissue structure.

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: An engineered three-dimensional structure includes living cells cohered with each other. The living cells suitably include Schwann cells and at least one other type of cell. The cells accompanying the Schwann cells can suitably be bone marrow stem cells or another type of cell having one or more anti-inflammatory properties. The structure is suitably a graft that facilitates restorative axon growth when the graft is implanted between the proximal and distal stubs of a severed nerve in a living organism. The graft can optionally include a plurality of acellular conduits extending between opposite axial ends of the graft. Bio-printing techniques can be used to assemble a three-dimensional construct that becomes through maturation an axon-guiding graft, by stacking a plurality of multicellular bodies, each of which includes a plurality of living cells cohered to one another to sufficiently to avoid collapsing when the multicellular bodies are stacked to form the structure.

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: Medical devices may be coated to minimize or substantially eliminate a biological organism's reaction to the introduction of the medical device to the organism. The medical devices may be coated with any number of biocompatible materials. Therapeutic drugs, agents or compounds may be mixed with the biocompatible materials and affixed to at least a portion of the medical device. In addition, these therapeutic drugs, agents and/or compounds may be utilized to promote healing, including the formation of blood clots. In addition, various polymer combinations may be utilized to control the elution rates of the therapeutic drugs, agents and/or compounds from the implantable medical devices.

Abstract: Methods and compositions for inducing apoptosis of cells, such as macrophages, at a lesioned site of a body vessel are disclosed herein. Nitric oxide can be directly or indirectly delivered to a treatment site to increase macrophage apoptosis. Delivery can include site specific delivery of nitric oxide gas, nitric oxide in aqueous solution or a substance(s) which releases nitric oxide or causes nitric oxide to be generated from an endogenous source. Delivery can be achieved by a delivery system such as a catheter assembly, stent or other suitable device.

Abstract: The invention relates to a flat device for facilitating the transplant of biological material, and consisting of a flat, central porous body with closing means at the ends thereof, a plunger that is inserted into the porous body and comprises an integrated closing element, and one or more seeding trays onto which the cells to be transplanted are deposited. The device can also consist of a comb-shaped plunger with two or more arms that are inserted into the porous body.

Abstract: A venous shunt method adapted to shunt cerebral spinal fluid in a patient. A fluid control device having a fluid passage is adapted to be placed allowing cerebral spinal fluid to flow through the fluid passage. A catheter having a lumen, the catheter being in fluid communication with the fluid control device. At least a portion of at least one of the catheter and the fluid control device being subjected to an anti-thrombogenic treatment.