Abstract: Articles such as catheters or balloons that have an ester-linked poly(ester-block-amide) substrate have a lubricious hydrogel coating which suppresses particle development under accelerated aging conditions. A polymerizable coating composition is applied to the substrate without application of an intervening primer layer and cured. The coating composition comprises an uncrosslinked polyvinylpyrrolidone polymer that is free of attached photoinitiator groups and at least one polyfunctional ethylenically unsaturated monomer.

Abstract: The invention relates to a method for producing a multi-layer collagen scaffold. The method generally comprises the steps of: preparing a first suspension of collagen and freezing or lyophilizing the suspension to provide a first layer; optionally preparing a further suspension of collagen and adding the further suspension onto the layer formed in the previous step to form a further layer, and freezing or lyophilizing the layers, wherein when the layer formed in the previous step is formed by lyophilization the lyophilized layer is re-hydrated prior to addition of the next layer; optionally, repeating the aforementioned step to form one or more further layers; and preparing a final suspension of collagen and pouring the final suspension onto the uppermost layer to form a final layer, and freeze-drying the layers to form the multilayer collagen composite scaffold.

Abstract: A drug-eluting stent comprises a coated layer prepared of a composition comprising a polymer and a drug, the coated layer being a single coated layer with the composition, or comprises a first coated layer prepared of the above composition and a second coated layer with a polymer alone, the first coated layer being coated by the second coated layer. The drug is a vascular intimal hyperplasia inhibitor which does not inhibit proliferation of endothelial cells, and the composition substantially excludes a lipid-soluble low-molecular compound. The polymer in the first layer is a copolymer of lactic acid (monomer A) and a terminal hydroxy straight alkyl carboxylic acid having 3 to 8 carbon atoms, and, if the second coated layer is formed, the polymer in the second coated layer is a poly(lactic acid), a poly(glycolic acid), or a poly(lactic acid-co-glycolic acid).

Abstract: The invention concerns a dried form of a porous polymer gel material which may be rehydrated and placed under pressure or compression to induce salvation, thereby forming a high concentration gel, in the form of an injectable viscous putty or dough, which may be implantated in the body.

Abstract: The present invention relates to pre-formulations comprising low viscosity, non-liquid crystalline, mixtures of: a) at least one neutral diacyl lipid and/or at least one tocopherol; b) at least one phospholipid; c) at least one biocompatible, oxygen containing, low viscosity organic solvent; wherein at least one bioactive agent is dissolved or dispersed in the low viscosity mixture and wherein the pre-formulation forms, or is capable of forming, at least one liquid crystalline phase structure upon contact with an aqueous fluid. The preformulations are suitable for generating parenteral, non-parenteral and topical depot compositions for sustained release of active agents. The invention additionally relates to a method of delivery of an active agent comprising administration of a preformulation of the invention, a method of treatment comprising administration of a preformulation of the invention and the use of a preformulation of the invention in a method for the manufacture of a medicament.

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: The invention provides fabricated PVA-hydrogels, PVA-hydrogel-containing compositions, and methods of making the same. The invention also provides methods of implanting or administering the PVA-hydrogels, or the PVA-hydrogel-containing compositions to treat a subject in need. Methods of cross-linking pre-solidified or pre-gelled hydrogel particles and making cross-linked PVA-hydrogels, and cross-linked PVA-hydrogel-containing compositions also are disclosed herein.

Abstract: A substance, which contains anti-inflammatory substances, anti-microbial substances, anti-tumor substances, anti-viral substances, and/or bone stimulating substances, as an additive, can be added to an UHMWPE material for the production of a medical implant for imparting benign body response properties to the medical implant.

Abstract: A tissue engineering composition adapted for application to an interior surface of a body lumen of a patient. The composition comprises (a) a carrier medium that is adapted to flow and to stably adhere the composition to the body lumen and (b) microcapsules, which are dispersed within the carrier medium and which contain one or more living cells encapsulated within a coating that includes a biodegradable polymer. The composition promotes growth of the cells on the lumen surface subsequent to application of the composition to the lumen.

Abstract: A coated implantable medical device is described, wherein the coating comprises a coating matrix and particles of one or more molecular sieves, preferably zeolite of zeogrid particles, optionally loaded with one or more bioactive agents. The coating matrix itself can function as a second drug-carrying interface. The coating comprising the molecular sieve material has an excellent biocompatibility and allows suitable drug delivery into the body of an animal, preferably a mammal and most preferably a human.

Abstract: Methods and devices relating to polymer-bioceramic composite implantable medical devices, such as stents are disclosed. A suspension solution is formed including a fluid, a biodegradable polymer, and bioceramic particles. The biodegradable polymer and particles are precipitated from the suspension to form a mixture. A composite is formed by combining the mixture with another polymer and a scaffolding is formed from the composite.

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: Coatings for medical devices, methods of making the coatings, and methods of using them are described.

Abstract: Disclosed herein is a hydrophilic foam. The hydrophilic foam includes a polyurethane matrix having a plurality of cells. The cells are capable of retaining water in an amount of least about 8 grams of water per gram of the hydrophilic foam.

Abstract: An article comprising two chemically grafted polymer layers comprising a hydrogel layer and an end-functionalized polyurethane layer. The invention also includes methods of making and using the article.

Abstract: The invention relates to the use of one or more growth factors in a drug delivery system, optionally with an external mesh housing, to recruit and optionally harvest progenitor cells. These cells include those that normally reside in the bone marrow.

Abstract: A polymer and a method for its preparation are provided. The polymer comprises poly(lactide), poly(lactide/glycolide) or poly(lactic acid/glycolic acid) segments bonded by ester linkages to both ends of an alkanediol core unit. The polymer is for use in a controlled release formulation for a medicament, preferably leuprolide acetate. The controlled release formulation is administered to a patient as a subcutaneous depot of a flowable composition comprising the polymer, a biocompatible solvent, and the medicament. Controlled release formulations comprising the polymer release leuprolide for treatment of prostate cancer patients over periods of 3-6 months.

Abstract: A process for the preparation of a bioadhesive laminate comprising a hot-melt extruded reservoir layer and a hot-melt extruded backing layer is provided. The reservoir layer comprises a thermoplastic bioadhesive composition containing an active agent. An active agent-containing thermoplastic bioadhesive hydrophilic composition is hot-melt coextruded with a hydrophobic composition to form at least a bi-layered laminate. The hydrophilic composition and the hydrophobic composition have at least one polymer in common. In addition, the melt flow index of the hydrophobic composition is within 50% of the melt flow index of the hydrophilic composition. As a result, the laminate has a uniform transverse cross-section and/or a uniform longitudinal cross-section throughout a major of the length of the laminate. Moreover, when the laminate is divided into unit doses of approximately the same size, they have a high degree of content uniformity with respect to the active agent(s) present therein.

Abstract: The implantable medical devices are configured to release at least one therapeutic agent from a matrix affixed to the implantable body with a release profile which is programmable to the agent and treatment. The matrix is formed such that the concentration of the therapeutic agent in the matrix varies as a gradient relative to a surface of the implantable body. The change in the concentration gradient of the agent in the matrix directly controls the rate of elution of the agent from the matrix. The therapeutic agent matrix can be disposed in the stent or on surfaces of the stent in various configurations, including within volumes defined by the stent, such as openings, holes, or concave surfaces, as a reservoir of agent, and alternatively as a coating on all or a portion of the surfaces of the stent 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 biological adhesive formulation comprising dextrin, at least one adhesiveness modifier agent, and at least one antibiotic is suitable for promoting healing of tissue in a patient, for example, to prevent anastomosis of a surgical wound in the digestive system of a patient, and for affixing prosthesis during a hernia operation in a patient and occluding a fistula within a patient.

Abstract: A retrievable, sustained release, solid dosage form is provided for implanting into cranial bony canals and for prolonged release of an anesthetic, whereby treating neurovascular conditions, such as migraine. The dosage comprises an anesthetic contained in a polymeric carrier, and a retrieval member, the anesthetic being gradually released from the carrier.

Abstract: The invention relates to pharmaceutical compositions having alkaline pH comprising S-nitrosoglutathione (GSNO) as active ingredient together with usual additives, optionally with one or more polysaccharide-type polymer(s). Another subject of the invention is a method for stabilizing a solution or non-solid composition containing GSNO wherein the pH of the solution or composition is adjusted to an alkaline value.

Abstract: The present invention relates to biocompatible non-woven fibrous materials having a nano-micro topography and methods for producing such materials. The materials may be used to cover implantable medical devices and to fabricate a three-dimensional drug-eluting fibrous matrix featuring accurate spatial positioning of the drug particles within the matrix.

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 flat self-curling permeable sheet membrane containing a matrix formed of crosslinked biopolymeric fibers. The matrix self-curls into a predetermined shape upon absorption of an aqueous fluid and is permeable to molecules having molecular weights not greater than 1×106 daltons. Also disclosed is a method of preparing such a flat self-curling permeable membrane.

Abstract: A demineralized bone matrix (DBM) or other matrix composition is provided that has been stabilized by lowering the pH of the composition, reducing the water content, adding water substitutes, and/or increasing the amount of deuterated water present in the composition in order to reduce the activity of endogenous degrading enzymes such as proteases. A hydrated form of a stabilized DBM composition may be stable up to a year at room temperature at acidic pH. The acidified DBM compositions may be further stabilized by the addition of a stabilizing agent such as deuterated water, water substitutes, polymers, protease inhibitors, glycerol or hydrogels.

Abstract: A controlled release multidrug formulation for improving locomotor recovery after spinal cord injury comprising: (a) a first composition comprising a first bioactive agent, encapsulated within a first polymeric particle; (b) a second composition comprising a second bioactive agent, encapsulated within a second polymeric particle, wherein the second polymeric particle is encapsulated within the first polymeric particle; and (c) a third composition comprising a third bioactive agent, encapsulated within either the first or the second polymeric particle, wherein the second composition is released subsequently to the release of the first composition, and wherein the first bioactive agent is a neurotrophic factor, the second bioactive agent is a collagen synthesis inhibitor, and the third bioactive agent is selected from the group consisting of cyclic AMP (cAMP), an adenylate cyclase activator and a Rho inhibitor.

Abstract: The present invention relates to a biocompatible polymer composition suitable for bone repair and a method of treating bone repair using a curable polymer composition wherein the cured composition has an elongation until rupture of at least 10%.

Abstract: This invention provides new and novel devices and methods for administering lithium (Li) ions to a mammalian subject, especially delivery of the lithium (Li) ions to a body component for example across a body or tissue surface such as skin or a mucosal membrane, or for the delivery of the lithium ions directly to bodily fluids in a controllable and reproducible manner. In certain embodiments the device comprises a donor electrode that is a donor of the lithium ions; a protective architecture that is ionically conductive to the lithium ions, configured for application to a skin surface and positioned to isolate said donor electrode from the skin surface; and a counter electrode configured for application to the skin surface, where said counter electrode is operably coupled to said donor electrode.

Abstract: A method of local treatment of specific bone defects such as osteoporosis or bone cysts comprises the step of local administration of a formulation comprising a fusion peptide containing a first domain comprising PTH or BMP 2 or BMP 7, and a second domain comprising a covalently crosslinkable substrate domain; and a material suitable of forming a biodegradable matrix suitable for cellular growth or in-growth, wherein the fusion peptide is covalently linked to the matrix. In one embodiment, the matrix contains one or more contrast agents, and is preferably formed in the absence of a growth factor. The matrix may be used in the treatment of fluid-filled cysts such as Tarlov cysts, ovarian cysts, arachnoid cysts, aneurysmal bone cysts or hepatic cysts.

Abstract: Extended release of sufentanil is provided by implanting a device containing sufentanil into a mammal or human being. The device may include a solid biocompatible polymer matrix, and sufentanil may be encapsulated within the polymer matrix. The polymer matrix comprises a plurality of pores configured to allow contact between the sufentanil and a physiological fluid of a mammal into which the device is implanted to thereby release sufentanil in vivo from the device into the mammal. The devices may be used to treat opioid addiction or pain.

Abstract: The invention relates to porous matrices based on a biologically compatible polymer or polymer mixture, to a cell implantation that is established on said matrices and to additional cell implantation based on cell mixtures of hepatocytes and islets of Langerhans. The invention also relates to a method for producing porous matrices, to matrices obtained according to said method and to a special method for obtaining cells for the inoculation of an implantable matrix.

Abstract: A method for fabricating a coating for an implantable medical device is provided comprising applying a first polymer on at least a portion of the device to form a first layer of the coating and applying a second polymer on at least a portion of the first layer to form a second layer of the coating. The second polymer has a lower degree of hydration than the first polymer.

Abstract: A coated medical device an 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: 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: 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: A biological adhesive formulation comprising dextrin, at least one adhesiveness modifier agent, and at least one antibiotic is suitable for promoting healing of tissue in a patient, for example, to prevent anastomosis of a surgical wound in the digestive system of a patient, and for affixing a prosthesis during a hernia operation.

Abstract: The invention provides methods of treating macular edema in a patient that include determining whether the patient has been diagnosed with or has experienced symptoms of macular edema for a predetermined period of time. If the patient has been diagnosed with or has experienced symptoms of macular edema for a predetermined period of time, the method of treatment includes administering a therapeutically effective amount of an AED to the patient. If the patient has not been diagnosed with or has experienced symptoms of macular edema for a predetermined period of time, the method of treatment optionally includes treating the patient with a therapy other than an AED. The invention further provides methods of treating macular edema in a patient using methods of and devices for administering an AED.

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: Described herein are nitric oxide (NO)-donating poly(tetrafluoroethylene) (PTFE) polymers and polymer surfaces and methods of making and using the same. The NO-donating PTFE polymers can be used to fabricate at least a portion of an implantable medical device, coat at least a portion of an implantable medical device or form at least a portion of an implantable medical device. The NO-donating PTFE polymers provide controlled release of NO once implanted at or within the target site.

Abstract: A coating for an implantable medical device is provided comprising a first layer including a first polymer and a second layer including a second polymer. The second layer is disposed over at least a portion of the first layer. The second polymer has a lower degree of hydration than the first polymer.

Abstract: Methods for coating medical devices for implantation within a body vessel are provided comprising providing a cylindrical container, placing a medical device inside the cylindrical container, and applying a polymer in liquid form inside the container.

Abstract: Therapeutic device intended for the selective cytoreductive treatment of an obstruction in a natural lumen or passage of the human or animal body, said lumen being obstructed by the effect of a local cell proliferation, said device comprising a tubular element, in particular of cylindrical shape, intended to be placed in said natural lumen and sufficiently flexible to conform to said natural lumen, but sufficiently rigid to maintain an artificial channel in said lumen. The tubular element supports lengthwise a medicinal sleeve which is intended to come into line with, and into contact with, the obstruction once the natural lumen has been intubated, and is designed to deliver locally, at least in its outer surface portion, at least one therapeutic agent which is cytoreductive, in particular cytotoxic, through contact with the cells under whose effect said lumen is obstructed.

Abstract: A thermally modified microbial-derived cellulose material is described for use as an implantable material in general surgery, plastic surgery and neurosurgery.

Abstract: The invention provides nucleic acid and polypeptide sequences encoding antibody based scaffolds such as full antibodies, antibody Fab fragments, single chain antibodies, soluble VEGF receptor-Fc fusion proteins, and/or anti-angiogenic PDGF receptors. Also encompassed are cell lines encoding such anti-angiogenic antibody scaffolds, VEGF receptors, and/or PDGF receptors. The invention also provides encapsulated cell therapy devices that are capable of delivering such anti-angiogenic antibody scaffolds, VEGF receptors, and/or PDGF receptors as well as methods of using these devices to deliver the anti-angiogenic antibody scaffolds, VEGF receptors, and/or PDGF receptors to medically treat disorders in patients, including ophthalmic, vascular, inflammatory, and cell proliferation diseases.

Abstract: Biocompatible amino acid anhydride polymers for use in tissue engineering, and methods for their preparation and use.

Abstract: The present invention provides variable pore size filters. The variable pore size filters of the present invention comprise a fabric matrix, having a set pore size, wherein the fabric matrix is coated with a gel that expands and shrinks in response to a trigger. When the gel is expanded, the pore size of the filter is small and filtering is accomplished. When the gel is shrunken, the pore size of the filter is large and cleaning of the filter by a backwash or forward flush of fluid is accomplished.

Abstract: A transplant/implant device for delivering at least one predetermined biologically active compound to a human or animal host system or for another biological function in the host system is produced by genetically engineering vital chondrocytes or mixing chondrocytes with another type of native or genetically engineered cells or mixing chondrocytes with artificial particles having a size comparable to the size of cells or combining at least two of the named steps of engineering or mixing and by subjecting the chondrocytes or the mixture comprising the chondrocytes to three dimensional culture conditions for in vitro production of cartilaginous tissue whereby the cells and/or the artificial particles are immobilized in the cartilaginous tissue. The chondrocytes produce and maintain the cartilaginous tissue and the chondrocytes themselves or cells of another cell type immobilized in the cartilaginous tissue are able to produce and secrete the at least one predetermined compound.