Abstract: This invention relates to biocompatible, biodegradable thermoplastic polyurethane or polyurethane/ureas comprising isocyanate, polyol and a conventional chain extender and/or a chain extender having a hydrolysable linking group and their use in tissue engineering and repair applications, particularly as stents and stent coating.

Abstract: There are provided methods for producing a hydrogel that is capable of adhesion of cells and which comprises enzymatically cross-linked conjugates of a hydrogel forming agent and a flavonoid, formed from a reaction using peroxide and peroxidase. Hydrogels produced by such methods and methods of using the hydrogels are also provided.

Abstract: A mixed dose of a nanosized drug wherein at least one portion of the mixed dose comprises a core nanosized drug encapsulated in at least one layer of a protective material having the same core drug or different core drug. A mixed dose of a nanosized drug wherein at least one portion of the mixed dose comprises a core nanosized drug encapsulated in at least one shell of a protective material with same drug concentration or different drug concentrations. A mixed dose of a nanosized drug wherein at least one portion of the mixed dose comprises a core nanosized drug encapsulated such that it has different release schedule than other portions of the drug. Methods and systems for manufacturing and administration of nanosized encapsulated drugs are also provided.

Abstract: A drug delivery device that includes a capsule for implantation into the body; the capsule further includes a reservoir for containing a substance such as a therapeutic agent, at least one port for allowing the substance to diffuse from or otherwise exit the reservoir, and a nanopore membrane in communication with the capsule at or near the exit port for controlling the rate of diffusion of the substance from the exit port. The device also includes an optional screen for providing structural stability to the nanopore membrane and for keeping the pores of the nanopore membrane clear. One embodiment of the drug delivery device includes an osmotic engine internal to the device for creating fluid flow through the device.

Abstract: A method of making a biocompatible, implantable medical device, including a vascular closure device is disclosed. The method includes forming a biocompatible polymer into at least one fiber and randomly orienting the at least one fiber into a fibrous structure having at least one interstitial spaces. Polymeric materials may be utilized to fabricate any of these devices. The polymeric materials may include additives such as drugs or other bioactive agents as well as antibacterial agents. In such instances, at least one agent, in therapeutic dosage, is incorporated into at least one of the fibrous structure and the at least one fiber.

Abstract: Bioactive implant for myocardial regeneration and ventricular chamber support including an elastomeric microporous membrane. The elastomeric microporous membrane being at least one non-degradable polymer and at least one partially degradable polymer. The non-degradable polymer is selected from polyethylacrylate and polyethylacrylate copolymerized with a hydroxyethylacrylate comonomer. The partially degradable polymer is selected from caprolactone 2-(methacryloyloxy)ethyl ester and caprolactone 2-(methacryloyloxy)ethyl ester copolymerized with ethylacrylate. The elastomeric microporous membrane further includes a nanofiber hydrogel, and cells. The bioactive implant, having one or two helical loops, contributes to the restauration of the heart conical shape.

Abstract: A method of inhibiting vascular intimal hyperplasia including: placing a stent within a blood vessel, the stent having a stent body of a cylindrical configuration having outer and inner surfaces with a diamond-like thin film coated on the surfaces, a first coated layer coating at least the outer surface of the stent body, the first coated layer being prepared of a first composition comprising a biodegradable polymer and a vascular intimal hyperplasia inhibitor of a kind, comprising argatroban, which does not inhibit proliferation of endothelial cells, the weight composition ratio of the polymer to the vascular intimal hyperplasia inhibitor being within the range of 8:2 to 7:3, and a second coated layer; and causing argatroban to be released from the stent to thereby inhibit the vascular intimal hyperplasia without inhibiting proliferation of endothelial cells.

Abstract: A method of UV curing and corresponding resulting non-polymeric cross-linked gel are provided. The cross-linked gel can be combined with a medical device structure. The cross-linked gel can provide anti-adhesion characteristics, in addition to improved healing and anti-inflammatory response. The cross-linked gel is generally formed of a naturally occurring oil, or an oil composition formed in part of a naturally occurring oil, that is at least partially cured forming a cross-linked gel derived from at least one fatty acid compound. In addition, the oil composition can include a therapeutic agent component, such as a drug or other bioactive agent. The curing method can vary the application of UV light in both intensity and duration to achieve a desired amount of cross-linking forming the gel.

Abstract: The present invention provides insertable medical devices having elastic surfaces associated with bioactive agent-containing microparticulates and a coating material. Upon expansion of the elastic surfaces the microparticulates can be released to a subject.

Abstract: One embodiment of the present invention is directed to compositions and methods for enhancing attachment of soft tissues to a metal prosthetic device. In one embodiment a construct is provided comprising a metal implant having a porous metal region, wherein the porous region exhibits a nano-textured surface, and a biocompatible polymer matrix coating the nano-textured surface. The polymer matrix coating comprises a naturally occurring extracellular matrix with biocompatible inorganic materials distributed within the matrix, or a biocompatible polymer and an osteo-inductive agent.

Abstract: Embodiments of the present disclosure provide for aligned nanofibrous polymer matrix structure, structures incorporating aligned nanofibrous polymer matrix structures, methods of using aligned nanofibrous polymer matrix structures, methods of making aligned nanofibrous polymer matrix structures, and the like.

Abstract: Coatings are provided in which surfaces may be activated by covalently bonding a combination of silane derivatives (A) to the metal surface, covalently bonding a lactone polymer (B) to the silane derivative by in situ ring opening polymerization, and depositing at least one layer of a polyester (C) on the bonded lactone polymer. Biologically active agents or therapeutic compounds may be deposited with any of the polyester layers. Such coated surfaces may be useful in medical devices, in particular stents.

Abstract: A collagen matrix material is charged with a cell growth-promoting derived nucleic acid sequence. The nucleic acid sequence-charged collagen matrix material may be utilized in a method of promoting regeneration of surface cartilage of a joint. In the method, an area of injury is covered with the nucleic acid sequence-charged collagen matrix material, the collagen matrix material is fixed over the area to be treated, and the area is allowed to heal.

Abstract: Provided herein is a three dimensional porous structure formed around an array of particles, where the particles define pores in the structure. The structure retreats away from the surface of the particles during formation, such that the particles optionally remain within the pores in the structure.

Abstract: Stents with coatings comprising a combination of a restenosis inhibitor comprising an HMG-CoA reductase inhibitor and a carrier. Also provided are methods of coating stents with a combination of an HMG-CoA reductase inhibitor and a carrier. A preferred example of a restenosis inhibitor is cerivastatin. The stent coatings have been shown to release restenosis inhibitors in their active forms.

Abstract: A polymer coating for medical devices based on a polyolefin derivative. A variety of polymers are described to make coatings for medical devices, particularly, for drug delivery stents. The polymers include homo-, co-, and terpolymers having at least one olefin-derived unit and at least one unit derived from vinyl alcohol, allyl alcohol and derivatives thereof.

Abstract: A stabilized bioadhesive composition containing an alkaline labile drug and a method for its preparation are provided. In one aspect, the composition is a hot-melt extruded (HME) composition comprising a preformed excipient mixture comprising an acidic component and an alkaline thermoplastic matrix-forming material, e.g. polymer. The excipient mixture is formed before blending with an alkaline labile drug. The blend is then hot-melt extruded to form the HME composition. By so doing, the acidic component is able to neutralize or render moderately acidic the excipient mixture. This particular process has been shown to substantially reduce the degradation of an alkaline labile drug during hot-melt extrusion. The excipient mixture softens or melts during hot-melt extrusion. It can dissolve or not dissolve drug-containing particles during extrusion.

Abstract: Osteoconductive matrices and methods are provided that have one or more statins disposed in calcium phosphate particles. The matrices may be injected into a fracture site. The osteoconductive matrices provided allow for sustained release of the statin and facilitate bone formation and repair of the fracture site.

Abstract: An injectable drug delivery device includes a core containing one or more drugs and one or more polymers. The core may be surrounded by one or more polymer outer layers (referred to herein as “coatings,” “skins,” or “outer layers”). In certain embodiments, the device is formed by extruding or otherwise preforming a polymeric skin for a drug core. The drug core may be co-extruded with the skin, or inserted into the skin after the skin has been extruded, and possibly cured. In other embodiments, the drug core may be coated with one or more polymer coatings. These techniques may be usefully applied to fabricate devices having a wide array of drug formulations and skins that can be selected to control the release rate profile and various other properties of the drugs in the drug core in a form suitable for injection using standard or non-standard gauge needles.

Abstract: This invention is a prosthetic device generally placed on the outside surface of the vessel or graft which then elutes antiproliferative drugs or agents from a drug-eluting matrix material. Methods of perivascular antiproliferative drug administration also are disclosed.

Abstract: A method of curing and corresponding resulting non-polymeric cross-linked gel are provided. The cross-linked gel can be combined with a medical device structure. The cross-linked gel can provide anti-adhesion characteristics, in addition to improved healing and anti-inflammatory response. The cross-linked gel is generally formed of a naturally occurring oil, or an oil composition formed in part of a naturally occurring oil, that is at least partially cured forming a cross-linked gel derived from at least one fatty acid compound. In addition, the oil composition can include a therapeutic agent component, such as a drug or other bioactive agent. The curing method can vary the application of heat in both temperature and duration to achieve a desired amount of cross-linking forming the gel.

Abstract: Coatings for an implantable medical device and a method of fabricating thereof are disclosed, the coatings comprising polymers of lactic acid.

Abstract: A medical article is disclosed, comprising a biologically degradable AB block copolymer and a biologically degradable polymer that is capable, at equilibrium and at room temperature, of absorbing less than about 5 mass % water.

Abstract: A pouch for forming an implantable artificial organ, including a closed shell provided in a semi-pervious membrane. The pouch further includes a sheet contained within the shell, the sheet including projections on the surface thereof for maintaining a space for cells between the sheet and the shell.

Abstract: Methods of treating renal cancers and other kidney-related inflammatory disorders with a bioabsorbable polymer scaffold (such as a stent) are described. The treatments are provided as alternative to complete or partial surgical removal of a diseased kidney.

Abstract: The present invention generally encompasses a medical article, such as a medical device or coating comprising an agent or combination of agents, wherein the agent is distributed throughout a polymeric matrix. The polymeric matrix comprises an agent and a poly(ester amide) having a design that was preselected to provide a predetermined release rate of the combination of agents from the medical article.

Abstract: The invention describes nanotextured super hydrophobic coatings that contain active agents which can elute from the coating over a period of time.

Abstract: Implant devices for intravesical administration and local drug delivery. The device has a body which includes a hollow tube formed of a biocompatible material; at least one reservoir in the tube which contains a drug; and one or more apertures through which the drug can be released. The device is configured for minimally invasive insertion into a body cavity, such as the bladder. The hollow tube may be elastomeric to permit the device to be elastically deformed from its initial shape into an elongated shape for passage through a catheter, where following such passage the device can return to or toward its initial shape to facilitate retention of the device in the body cavity. The body may have a narrow, elongated shape effective to permit insertion of the drug delivery device through a catheter without necessarily deforming the body, yet include flexible projections which effect retention within the body cavity.

Abstract: A method of modifying a medical device such as a stent with nano-constructs is disclosed. The method comprises applying a first fluid to the stent; immersing the stent being wet from the first fluid into a second fluid having a suspension of nano-constructs; and removing the stent from the second fluid and allowing the first and second fluid to be removed such that the nano-constructs are carried by the stent for in vivo application of the constructs to a target location of a mammalian subject. The nano-constructs can be attached to the surface of the stent, can be attached to a surface of the coating of the stent, can be embedded into the stent, or can be embedded into the coating.

Abstract: The present invention provides compositions for extended release of a nucleic acid agent, a biodegradable polymer. The present invention also provides methods of producing the matrix compositions and methods for using the matrix compositions to provide controlled release of the nucleic acid agent.

Abstract: A blood vessel model which imitates a human blood vessel including an aqueous gel made from polyvinyl alcohol having an average polymerization degree of 300 to 3500 and a saponification degree of 90% by mole or more, and silica particles; and a method for producing a blood vessel model which imitates a human blood vessel, including filling a mixed solution containing polyvinyl alcohol having an average polymerization degree of 300 to 3500 and a saponification degree of 90% by mole or more, silica particles and water in a mold for forming a blood vessel model, and freezing the mixture at a temperature of ?10° C. or lower, followed by thawing. The blood vessel model can be suitably used as a blood vessel model for practicing insertion of a stent graft into an aneurysm, a blood vessel model for practicing resection or ligation surgery of a blood vessel, and the like.

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 provides compositions, methods, and kits for treatment of opiate addiction and pain. The invention provides a biocompatible nonerodible polymeric device which releases buprenorphine continuously with generally linear release kinetics for extended periods of time. Buprenorphine is released through pores that open to the surface of the polymeric matrix in which it is encapsulated. The device may be administered subcutaneously to an individual in need of continuous treatment with buprenorphine.

Abstract: An implant for insertion through a punctum and into a canalicular lumen of a patient. The implant includes a matrix of material, a therapeutic agent dispersed in the matrix of material, a sheath disposed over a portion of the matrix of material and configured to inhibit the therapeutic agent from being released from the matrix of material into the canalicular lumen and to allow the therapeutic agent to be released from a surface of the matrix of material to a tear film, and a retention structure configured to retain the implant within the canalicular lumen.

Abstract: A spacing device for use in fenestrations of the paranasal sinus, the device including a sheath which forms a hollow body defining at least two apertures. The sheath includes at least one layer loaded with an active substance. The ratio q of the external diameter ra of the hollow body to the internal diameter ri of the hollow body is about 1.2 to 3.0.

Abstract: Shaped, composite bodies are provided. One portion of the shaped bodies comprises an RPR-derived porous inorganic material, preferably a calcium phosphate. Another portion of the composite bodies is a different solid material, preferably metal, glass, ceramic or polymeric. The shaped bodies are especially suitable for orthopaedic and other surgical use.

Abstract: Compositions and methods are provided for a matrix that inhibits bone growth in a patient in need thereof. In one embodiment, a method of inhibiting bone growth is provided, the method comprising: implanting a matrix at a target tissue site, the matrix comprising a biodegradable polymer and dextran loaded in the matrix in an amount of from about 5% to about 95% by weight based on a total weight of the matrix.

Abstract: A coated medical device and a method of providing a coating on an implantable medical device result in a medical device having a bio-absorbable coating. The coating includes a bio-absorbable carrier component. In addition to the bio-absorbable carrier component, a therapeutic agent component can also be provided. The coated medical device is implantable in a patient to effect controlled delivery of the coating, including the therapeutic agent, to the patient.

Abstract: A semi-solid delivery vehicle contains a polyorthoester and an excipient, and a semi-solid pharmaceutical composition contains an active agent and the delivery vehicle. The pharmaceutical composition may be a topical, syringable, or injectable formulation; and is suitable for local delivery of the active agent. Methods of treatment are also disclosed.

Abstract: The invention is a series of soft lithographic methods for the microfabrication of biopolymer scaffolds for use in tissue engineering and the development of artificial organs. The methods present a wide range of possibilities to construct two- and three-dimensional scaffolds with desired characteristics according to the final application. The methods utilize an elastomer mold which the biopolymer scaffold is cast. The methods allow for the rapid and inexpensive production of biopolymer scaffolds with limited specialized equipment and user expertise.

Abstract: Protein preparations containing biologically active compounds and the application of the protein preparations obtained, particularly as a component of medicinal and cosmetic preparations as protective substances or in the regeneration of cells and tissues of the human organism, and which can comprise a component of culture media for dermal or hepatic tissues, or for stem cells destined for use in the regeneration of cells and tissues in the human organism.

Abstract: The invention described is directed to an intracorporeal occluding device having elements with non-traumatic ends and devices, systems and methods for occluding the lumens of anatomical passageways and/or for delivering drugs or other substances to the bodies of human or animal subjects.

Abstract: A method for treating a surface with a therapeutic agent is disclosed. The method comprises precipitating a therapeutic agent from a hydrophilic polymeric base layer with which the therapeutic agent has been complexed, to form a layer comprising microparticles of the therapeutic agent on the hydrophilic polymeric base layer, the hydrophilic polymeric base layer being grafted to the surface. Devices comprising a surface having a hydrophilic polymeric base layer comprising a hydrophilic polymer grafted to the surface and a layer comprising microparticles of a therapeutic agent disposed on and complexed with the hydrophilic polymeric base layer are also disclosed.

Abstract: Implantable or insertable medical devices are provided, which comprises: (a) a biocompatible polymer; and (b) at least one therapeutic agent selected from an anti-inflammatory agent, an analgesic agent, an anesthetic agent, and an antispasmodic agent. The medical devices are adapted for implantation or insertion at a site associated with pain or discomfort upon implantation or insertion. In many embodiments, the therapeutic will be selected from at least one of (i) ketorolac and pharmaceutically acceptable salts thereof (e.g., ketorolac tromethamine) and (ii) 4-diethylamino-2-butynylphenylcyclohexyl glycolate and pharmaceutically acceptable salts thereof (e.g., oxybutynin chloride). Also provided are uses for the implantable or insertable medical devices, which uses comprise reducing pain or discomfort accompanying the implantation or insertion of such devices. Further uses may comprise reducing microbial buildup along the device.

Abstract: A aliphatic polyester polymer for stent coating is described.

Abstract: The present invention provides methods of promoting the revascularization and/or reenervation of central nervous system lesions using an in-situ crosslinkable hydrogel. The present invention also provides methods of treating a spinal cord injury by topically delivering to the spinal cord injury site a vehicle comprising a neurotrophic factor and/or anti-inflammatory agent. Also provided are methods of treating a spinal cord injury by topically administering or delivering a hydrogel to the injury site.

Abstract: Compositions and methods for sealing, coating and adhering tissues are provided that utilize a polymeric system comprising at least a Polymer and a crosslinking agent; and, optionally, (i) a Gelation Disrupting Agent, (ii) an Augmentative Polymer or Monomer, (iii) an Adjunct Compound (iv) an Antimicrobial Agent (v) an Adhesion Enhancer, (vi) a Crosslink Augmentating Agent or any combination thereof. Additionally, a Therapeutic Agent may be incorporated.

Abstract: The various embodiments herein relate to an injectable matrix used for regeneration, reconstruction, repair or replacement of organ or tissue. The injectable matrix consists of a synthetic and natural polymer, a stem cell niche and nanoparticles in the form of cups filled with growth factor and physiologic agent. The embodiments herein also provide a method for regeneration, reconstruction, repair or replacement of organ or tissue. In the method, an injectable matrix is injected to create three dimensional matrix system or network in an area of the desired tissue or organ, migration of blood circulatory stem cells or tissue-specific progenitor cells occur to the injected area of the tissue or organ. The growth factors and physiological agent present in the nanocups are released. The stem cells proliferate and differentiate to form the desired organ or tissue.

Abstract: An improved drug delivery composition and method of use is disclosed. The composition comprises one or more biodegradable block copolymer drug carriers; and a reconstitution enhancing and enabling agent comprising polyethylene glycol (PEG), a PEG derivative or a mixture of PEG and a PEG derivative. The composition can be administered as is or after being be dissolved or rapidly reconstituted in an aqueous vehicle to afford a homogeneous solution or uniform colloidal systems.

Abstract: Embodiments of surgical grafts, and methods, for the delivery of therapeutic agents to a target tissue via acellular matrices, are described. In some embodiments, nonviable matrices are successful in preventing or lessening adhesion formation by guiding tissue repair and remodeling, while also providing the target tissue with therapeutic agents that can act as repair and remodeling factors. An exemplary method to modulate flexor tendon healing and provide elimination or reduction of fibrotic adhesions involves loading a freeze-dried flexor digitorum longus allograft with recombinant adeno-associated viral (rAAV) vectors for the targeted and transient expression of growth/differentiation factor 5 (GDF5).