Abstract: Continuous processing methods for making absorbable polymeric non-wovens with one or more of the following properties: high burst strength, fine fibers of average diameter from 1 ?m to 50 ?m, and thickness from 10 ?m to 50 mm, have been developed. Improved fiber cohesion is made possible by allowing the fibers of the non-woven to initially remain molten during web collection. In the preferred embodiment, the polymer is a polyhydroxyalkanoate, and in the most preferred embodiment, the polymer comprises 4-hydroxybutyrate. A particularly preferred embodiment is a non-woven of poly-4-hydroxybutyrate or copolymer thereof, wherein the non-woven has a burst strength greater than 0.1 Kgf, wherein the non-woven is derived by a continuous melt-blown process. The non-wovens can be used for a variety of purposes including fabrication of medical devices.

Abstract: According to the present invention, a method for enhancing transdermal transport is disclosed. The method includes the steps of increasing a permeability of an area of a membrane with a permeabilizing device. The membrane may be, inter alia, biologic skin or synthetic skin. The permeabilizing device may be an ultrasound-producing device. A substance is transported into and through the area of the membrane. The substance may be a drug, a vaccine, or a component of interstitial fluid.

Abstract: A flexible, multilayer wound dressing with antibacterial and antifungal properties, together with methods for making the dressing. The dressing includes a layer of silver-containing fabric, a layer of absorbent material, and (optionally) a layer of flexible air-permeable and/or water-impermeable material. The dressing can be used for prophylactic and therapeutic care and treatment of skin infections and surface wounds (including surgical incisions), as a packing material, and as a swab for surface cleaning.

Abstract: Methods for making biomaterials for augmentation of soft and hard tissues, kits containing precursors for forming the biomaterials, and the resulting biomaterials are described herein. The biomaterials are formed from at least a first and a second precursor component. The first precursor component contains at least two nucleophilic groups, and the second precursor component contains at least two electrophilic groups. The nucleophilic and electrophilic groups of the first and second precursor components form covalent linkages with each other at physiological temperatures. The precursors are selected based on the desired properties of the biomaterial. In the preferred embodiment, the first precursor is a siloxane. Optionally, the biomaterials contain additives, such as thixotropic agents, radiopaque agents, or bioactive agents. In the preferred embodiment, the biomaterials are used to augment at least one vertebra of the spine (vertebroplasty).

Abstract: The present invention provides compositions and systems for delivery of nanocarriers to cells of the immune system. The invention provides synthetic nanocarriers capable of eliciting an immune system response in the form of antibody production, wherein the nanocarriers lack any T cell antigens. In some embodiments, the invention provides nanocarriers that comprise an immunofeature surface, which provides high avidity binding of the nanocarriers to antigen presenting cells. The invention provides pharmaceutical compositions comprising inventive nanocarriers. The present invention provides methods of designing, manufacturing, and using inventive nanocarriers and pharmaceutical compositions thereof.

Abstract: The present invention makes available methods and reagents for modulating proliferation or differentiation in a cell or tissue comprising contacting the cell with a compound. In certain embodiments, the methods and reagents may be employed to correct or inhibit an aberrant or unwanted growth state, e.g., by antagonizing a normal patched pathway or agonizing smoothened or hedgehog activity.

Abstract: A coaxial implant has been developed using entirely biodegradable polymeric materials. As referred to herein, a coaxial implant is a device having a core containing drug, surrounded by a semi-permeable membrane that controls the rate of release of material from the core. The device is formed by extrusion, using a pre-milling and extruding step to maximize uniformity of drug dispersion within the polymeric material. In one embodiment, the polymer is processed to yield a semi-crystalline polymer, rather than an amorphous polymer. The core containing the drug and the polymer membrane(s) can be the same or different polymer. The polymer can be the same or different composition (i.e., both polycaprolactone, or both poly(lactide-co-glycolide) of different monomer ratios, or polycaprolactone outside of a core of poly(lactide)), of the same or different molecular weights, and of the same or different chemical structure (i.e., crystalline, semi-crystalline or amorphous).

Abstract: A method for corrective surgery in a human subject of a vocal cord defect amenable to rectification by the augmentation of tissue subadjacent to the vocal cord defect, the method comprising: injecting an effective amount of autologous in vitro cultured fibroblast cells into the lamina propia, Reinke's space, the lateral tissue or the lateral edge of the vocal cord tissue of the subject in a position subadjacent to the vocal cord defect, wherein the in vitro fibroblast cultured cells are retrieved from the subject.

Abstract: Disclosed are compositions and methods for treating Guillain-Barré syndrome (GBS) in a subject that involves neutralizing specific pathogenic anti-glycolipid antibodies in the circulation of the subject. This can involve administering to the subject a molecular mimic of a ganglioside that serves as a specific competitive inhibitor for anti-ganglioside antibodies in the circulation. Also disclosed is an animal model of GBS having anti-ganglioside antibodies in the circulation.

Abstract: Polyhydroxyalkanoates (PHAs) from which pyrogen has been removed are provided for use in numerous biomedical applications. 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. PHAs are provided which are suitable for use in in vivo applications such as in tissue coatings, stents, sutures, tubing, bone and other prostheses, bone or tissue cements, tissue regeneration devices, wound dressings, drug delivery, and for diagnostic and prophylactic uses.

Abstract: A topical composition and the method using the composition, which contains an antifungal agent and a low potency anti-inflammatory steroid which is safe and effective such as desonide or its derivative. The low potency steroid agent does not cause side effects such as skin atrophy, striae and hypopigmentation. In a representative example, the low potency anti-inflammatory steroid has the following structure: wherein R1, R2, R3, and R4 taken independently can be H, C1-C10 alkyl, C1-C10 alkenyl, C3-C10 cycloalkyl, and phenyl groups; R1 and R2 taken together can be C3-C10 cycloalkyl; and R3, and R4 taken independently can be H, C1-C10 alkyl, C1-C10 alkenyl, C3-C10 cycloalkyl, phenyl, C7-C10 phenylalkyl, carboxylate, sulfonyl, phosphoryl, and phosphonyl groups. The composition can be formulated in a dosage form such as a cream, ointment, gel, lotion, foam, powder, aerosol, spray, shampoo, or liquid solution.

Abstract: Conductive polymer coatings and methods of forming the same are provided.

Abstract: Drug delivery compositions which are suitable for vaginal administration for the treatment of diseases and disorders in the urogenital tract are described. The compositions may be in the form of a tablet, liquid suspension or dispersion, dried powder, topical ointment, cream, foam, suppository, or aerosol. The drug delivery compositions are administered directly to the vagina and do not require the use of a solid device. This method of administration reduces the systematic levels of the drugs.

Abstract: Compositions for wound healing, use of the compositions, and kits and methods of using thereof are described herein. In a preferred aspect, the compositions are suitable for use in a method for forming a fibrin matrix or foam that can be applied or injected at the site of need. In another preferred aspect, the compositions are also suitable for use in methods for forming enhanced controlled delivery fibrin matrices that can be administered as gels or foams.

Abstract: The invention relates to a transdermal analyte monitoring system comprising a medium adapted to interface with a biological membrane and to receive an analyte from the biological membrane and an electrode assembly comprising a plurality of electrodes, wherein the medium is adapted to react continuously with the analyte, an electrical signal is detected by the electrode assembly, and the electrical signal correlates to an analyte value. The analyte value may be the flux of the analyte through the biological membrane or the concentration of the analyte in a body fluid of a subject. The medium may comprise a vinyl acetate based hydrogel, an agarose based hydrogel, or a polyethylene glycol diacrylate (PEG-DA) based hydrogel, for example. The surface region of the electrode may comprise pure platinum. The system may include an interference filter located between the biological membrane and the electrode assembly for reducing interference in the system.

Abstract: Methods and compositions for determining whether a subject will age without developing cognitive decline are provided. An exemplary method includes detecting one or more allelic variants in a gene encoding low density lipoprotein-related protein 1B. In a preferred embodiment, the detecting step is accomplished by contacting a sample obtained from the subject with a probe that forms a detectable complex with a nucleic acid in the sample containing an allelic variant indicative of aging without developing cognitive decline, wherein detection of the allelic variant in the sample indicates that the subject will age without developing cognitive decline.

Abstract: The present invention provides fluid and material delivery methods and devices for practicing the methods. The invention provides a method of delivering cellular material comprising injecting the cellular material into a subject such that the injected cells retain their inherent morphologic characteristics upon injection. The method comprises the steps of aspirating the cellular material into a fluid delivery device which incorporates a syringe arrangement. The cellular material is aspirated into the main body of the syringe until the desired amount of a material has filled the syringe body. The needle of the fluid delivery device is then inserted into the skin of a subject at an angle about parallel to the skin until a desired depth has been reached. The cellular material is then injected in the subject until the desired volume of material has been injected. The needle of the device is then rotated approximately 45 to 90 degrees and the needle is removed from the injection site.

Abstract: The invention provides a method for diagnosing amyotrophic lateral sclerosis (ALS) in a subject, a method for assessing the effectiveness of a drug in treating ALS, and a method for determining the site of onset of ALS in a subject. Each method comprises (a) obtaining a sample from the subject, (b) analyzing the proteins in the sample by mass spectroscopy, and (c) determining a mass spectral profile for the sample. In some embodiments, the method comprises comparing the mass spectral profile of the sample to the mass spectral profile of a positive or a negative standard.

Abstract: A process has been developed to selectively dissociate target molecules into component products compositionally distinct from the target molecule, wherein the bonds of the target molecule do not reform because the components are no longer reactive with each other. Dissociation is affected by treating the target molecule with light at a frequency and intensity, alone or in combination with a catalyst in an amount effective to selectively break bonds within the target molecule. Dissociation does not result in re-association into the target molecule by the reverse process, and does not produce component products which have a change in oxidation number or state incorporated oxygen or other additives because the process does not proceed via a typical reduction-oxidation mechanism. Target molecules include ammonia for waste reclamation and treatment, PCB remediation, and targeted drug delivery.

Abstract: Core-excited nanoparticle thermotherapy (CENT), is an improved material for use in thermotherapy. The CENT method uses both core-exciting energy (including x-rays) and core-shell nanoparticles, specifically designed to absorb radiation in their core structure, then transfer energy from the core to the shell, to heat the outer shell of the nanoparticle. The heated nanoparticle then heats the surrounding region to a temperature sufficient to detect, affect, damage and/or destroy the targeted cell or material. CENT nanoparticles can be bound to targeting agents that deliver them to the region of the diseased cell.