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: Methods and delivery agents for treatment of connective tissue that includes elastic fibers are described. Delivery agents are nano- or micro-sized particles that include a biologically active compound useful in treatment of degraded elastic fibers and an anchoring agent at a surface that binds at or near the area of degraded elastic fibers. The delivery agents may be utilized for targeted delivery of biologically active compounds to degraded elastic fibers so as to maintain and/or regenerate the elastin component of connective tissue, and prevent further degradation and/or rehabilitate the structural architecture of the connective tissue.

Abstract: The present invention relates to an injectable system combining a hydrogel, a bioceramic and a degradable matrix that provides for sustained drug delivery and structural support to recovering tissue, such as bone and the periodontium.

Abstract: Synthetic polymeric vascular grafts that promote endothelial healing and methods of their preparation and use are provided.

Abstract: The disclosure relates to a cosmetic composition for the temporary shaping of hair, containing a combination of an anionic acrylate polymer and an amphoteric polymer. The cosmetic composition provides an extremely good moisture resistance.

Abstract: The invention relates to (among other things) a method comprising the steps of (a) administering to a patient a PARP-inhibiting amount of a PARP inhibitor; and (b) administering to the patient a topoisomerase I-inhibiting amount of a long-acting topoisomerase I inhibitor.

Abstract: The present invention provides for a stabilized biodegradable polymeric composition useful as a controlled release delivery system for peptide agents. The compositions of the present invention comprise a) a beneficial salt of a luteinizing hormone releasing hormone (LHRH) analogue formed with a strong acid that minimizes or prevents the interaction/reaction between the LHRH and the polymer in an organic solution; b) a biodegradable polymer; c) a pharmaceutically acceptable organic solvent; and d) optionally one or more excipients. The present invention also relates to a method of manufacturing and a method of use thereof.

Abstract: Disclosed is a biodegradable sheet comprising at least one layer which is a direct contact layer, intended to successfully contact materials, such as liquids, while maintaining the mechanical properties of the sheet and to extend the biodegradable sheet shelf life. The direct contact layer may comprise a hydrophobic polymer selected from poly(epsilon-caprolactone) (PCL) polyhydroxybutyrate (PHB), Polydioxanone (PDO) polyglycolic acid (PGA), polybutylene succinate (PBS), polybutylene succinate adipate (PBSA), poly lactic acid (PLA), polybutylene adipate terphtalate (PBAT), polyhydroxyalkanoates (PHA), such as polyhydroxybutyrates (PHB), polyhydroxyvalerates (PHV), and polyhydroxybutyrate-hydroxyvalerate copolymers (PHBV) or any mixture thereof. The biodegradable sheet may further comprise surface treated nanoclay particles, PVOH grafted with a crosslinker and PBS or PBSA The biodegradable sheet may further include at least one metalized, biodegradable, laminate layer.

Abstract: A multi-laminar electrospun nanofiber scaffold for use in repairing a defect in a tissue substrate is provided. The scaffold includes a first layer formed by a first plurality of electrospun polymeric fibers, and a second layer formed by a second plurality of electrospun polymeric fibers. The second layer is combined with the first layer. A first portion of the scaffold includes a higher density of fibers than a second portion of the scaffold, and the first portion has a higher tensile strength than the second portion. The scaffold is configured to degrade via hydrolysis after at least one of a predetermined time or an environmental condition. The scaffold is configured to be applied to the tissue substrate containing the defect, and is sufficiently flexible to facilitate application of the scaffold to uneven surfaces of the tissue substrate, and to enable movement of the scaffold by the tissue substrate.

Abstract: Novel hybrid materials and fabrication methods thereof are provided. The novel hybrid materials can include a biodegradable polymer and a biodegradable metallic material. The hybrid material can also include a coupling agent between the biodegradable metallic material and the biodegradable polymer. A method of fabricating a hybrid material can include performing a surface treatment process on the biodegradable metallic material, and then either performing a solvent formation method or a thermal formation method.

Abstract: A malleable demineralized bone composition consists of cortical bone made from a first portion and a second portion. The first portion of cortical bone is made from cut pieces freeze dried then ground into particles and demineralized then freeze-dried. The second portion of cortical bone is shaved into shavings. The shavings are long thin strips subjected to freeze-drying. The freeze-dried shavings are ground and demineralized and then freeze-dried. A volume of the second portion is placed in a solution of sterile water to create a mixture, the water volume being twice the second portion, the mixture is autoclaved under heat and pressure to form a gelatin, and the first portion is mixed with the gelatin to form a malleable putty or paste.

Abstract: The present invention relates to biomedically useful compositions of C2-C3 linked polyethers of 1,6:2,3-dianhydrohexopyranose derivatives combined with effective amounts of one or more bioactive agents. In certain embodiments the C2-C3 linked polyether of a 1,6:2,3-dianhydrohexopyranose derivatives are aqueous insoluble. In certain other embodiments biomedically useful compositions have the physical form of microparticles, microspheres, tubes, rods, sheets, membranes, fibers and the like. In certain embodiments the bioactive agent is a protein.

Abstract: Apparatus for producing a three dimensional nanofiber structure includes (1) at least two spaced electrodes; (2) a spinner adapted to rotate the at least two spaced electrodes; (3) a syringe assembly adapted to eject a polymer solution from a syringe of the syringe assembly towards the at least two spaced electrodes while the at least two spaced electrodes are rotated by the spinner; and (4) a power supply assembly for providing the two spaced electrodes at a first electric potential, and for providing the syringe at a second electric potential which is different from the first electric potential. A composition of matter may include (1) a least one layer of nanofibers in which a distribution of angles of fibers is “aligned;” and (2) at least one gel layer, wherein the at least one layer of microfibers and the at least one gel layer alternate to form a laminate.

Abstract: The disclosed subject matter relates to brush polymer-oligonucleotide conjugates comprising oligonucleotides covalently attached to the backbone of a non-cationic, sterically congested brush polymer and the use of such polymer-oligonucleotide conjugates in antisense gene regulation and as diagnostic agents.

Abstract: A process of forming a lactide copolymer includes forming a dimethylidene lactide molecule from an L-lactide molecule. The process also includes forming a functionalized lactide monomer from the dimethylidene lactide molecule. The process includes forming a mixture that includes the functionalized lactide monomer and a bisphenol A (BPA) monomer or a BPA-derived monomer. The process further includes polymerizing the mixture to form a lactide copolymer.

Abstract: A three-dimensional electrospun nanofiber scaffold for use in repairing a defect in a tissue substrate is provided. The scaffold includes a flexible deposited fiber network of varying density including a first and second set of set of electrospun fibers. The second set of electrospun fibers is coupled to the first. A first portion of the flexible deposited fiber network includes a higher density of fibers than a second portion of the flexible deposited fiber network, and the tensile strength of first portion is higher than that of the second portion. The scaffold is sufficiently flexible to facilitate application of scaffold to uneven surfaces of the tissue substrate, and enables movement of the scaffold by the tissue substrate. The first and second set of fibers are configured to degrade within three months after application, and each fiber of the deposited fiber network has a diameter of 1-1000 nanometers.

Abstract: Devices and methods for visibly highlighting areas of a region including an imager configured to image the region with a sensitivity to at least one of wavelength, light level, or contrast greater than the human eye, an overlay element configured to visibly highlight areas of the region and registered to the imager to produce alignment of imaged features with highlighted features at the same location on the region, and at least one of a controller executing a program or logic configured to process acquired images from the imager to identify areas of the region determined not visible to the human eye, and control the overlay element to visibly highlight those areas on the region.

Abstract: The instant invention relates to a solid product comprising a liquid biologically active agent which is intimately associated to a stabilizing agent; particularly a solid product that can be reconstituted to a clear, stable, stabilized nanodispersion or loaded micelles comprising a polymer as a stabilizing agent and a liquid, preferably water immiscible, biologically active agent. The instant invention is further directed toward a process for the production of the above solid product; particularly to micelles or nanodispersions produced by hydration of a cake or powder of the solid product, produced via an effective treatment of a stabilized solution comprising for example a polymer as a stabilizing agent, such as an amphiphilic block copolymer or a small molecular weight surfactant, loaded with a liquid biologically active agent, such as propofol, an optional additive, and a suitable solvent.

Abstract: Methods and apparatus are disclosed for customizing an elution profile of a stent after manufacture of the stent has been completed. The stent includes a plurality of side ports for eluting a drug formulation within a lumenal space of a hollow strut that forms the stent. An effective diameter of at least one side port of the plurality of side ports of the stent is modified in order to customize an elution profile of the stent. In an embodiment hereof, the plurality of side ports are completely blocked or plugged with a filler material during the manufacture of the stent and at least a portion of the filler material is removed to increase an effective diameter of at least one side port of the plurality of side ports of the stent in order to customize an elution profile of the stent.

Abstract: The present invention describes an X-ray contrast composition for local administration, wherein the X-ray contrast composition exhibits contrast properties and wherein at least 60% of an administrated amount of said X-ray contrast composition remains more than 24 hours within 10 cm from an injection point when the X-ray contrast composition is administrated to a human or animal body.

Abstract: A method is provided for local controlled delivery of a drug to the seminal vesicle, the prostate, the ejaculatory duct, or the vas deferens of a patient in need of treatment. In one embodiment, the method includes implanting a resorbable drug delivery device within the seminal vesicle, the prostate, the ejaculatory duct, or the vas deferens of the patient. The drug delivery device may include an elastic device body housing at least one drug reservoir which contains at least one drug. In a preferred embodiment, the method further includes releasing the drug from the device in a controlled manner to, typically directly to, the seminal vesicle, the prostate, the ejaculatory duct, or the vas deferens.

Abstract: Described are gastric residence structures that include an active substance. The gastric residence structures may include one or more arms that include a loadable polymeric component, an elastic polymeric component, and a separate linker component. The linker may connect the one or more arms with the elastic polymeric component. The gastric residence structures may be configured to be folded and physically constrained during administration and may be configured to assume an open retention shape upon removal of a constraint. The change between the folded shape and the open retention shape may be mediated by the elastic polymeric component that undergoes elastic deformation when the residence structure is in the folded shape and recoils when the gastric residence structure assumes the open retention shape.

Abstract: Some invention embodiments relate to an implant having a base body composed of a biocorrodible magnesium alloy and a polylactide coating. The implant is characterized in that the coating contains seed crystals and/or lipophilic substances as additives.

Abstract: Embodiments of the present disclosure are directed to perforated polymer films and methods of making the same. In some embodiments, the films are for use with implantable medical devices. In one embodiment there is a flexible body including a polymer film having a first surface and an opposing second surface, the film having a plurality of apertures extending from the first surface to the second surface and a plurality of raised lips protruding from the first surface such that each of the plurality of apertures is surrounded by a one of the plurality of raised lips. In one embodiment, the film comprises a single layer, and in another embodiment, the film can comprise a plurality of layers. In certain embodiments, the film can comprise an adhesive layer. In another embodiment, one or more of the layers may be a drug containing layer and/or a rate controlling layer for drug release.

Abstract: Methods, devices, and medicaments that include trospium are provided for use in the treatment of bladder dysfunction by locally administering the trospium into the bladder to achieve a sustained concentration of trospium in urine in the bladder sufficient to produce a therapeutic concentration of trospium in bladder tissue. The drug may be delivered into the bladder from an intravesical drug delivery device inserted into the bladder, wherein the device continuously releases the drug into the urine in the bladder over an extended period of hours or days.

Abstract: Bioactive porous bone graft implants in various forms suitable for use in bone tissue regeneration and/or repair, as well as methods of use are provided. The implants are formed of bioactive glass and have an engineered porosity. The implants may be contained in polymer for enhanced clinical results and better handling.

Abstract: A method for generating three-dimensional facial models and photorealistic textures from inferences using deep neural networks relies upon generating a low frequency and a high frequency albedo map of the full and partial face, respectively. Then, the high frequency albedo map may be used for comparison with correlation matrices generated by a neural network trained by a large scale, high-resolution facial dataset with simulated partial visibility. The corresponding correlation matrices of the complete facial textures can then be retrieved. Finally, a full facial texture map may be synthesized, using convex combinations of the correlation matrices. A photorealistic facial texture for the three-dimensional face rendering can be obtained through optimization using the deep neural network and a loss function that incorporates the blended target correlation matrices.

Abstract: Disclosed are methods of subcutaneous delivery of a drug or a therapeutic agent to a subject comprising administering to said subject a tumescent composition comprising: (a) the drug or the therapeutic agent, wherein a tumescent concentration of the drug is simultaneously: 1) below a threshold for local, subcutaneous tissue toxicity, 2) above a threshold for positive local therapeutic effect, and 3) above a concentration achievable by intravenous (IV), intramuscular (IM) or oral (PO) delivery; (b) a vasoconstrictor; and (c) a pharmaceutically acceptable carrier. Some embodiments relate to a method of treating or preventing sepsis or Systemic Inflammatory Response Syndrome (SIRS) in a subject. Some embodiments relate to a tumescent solution for treating a localized viral infection, e.g., varicella-zoster (shingles), the tumescent solution comprising an antiviral agent.

Abstract: The present invention relates to a modified collagen obtainable by providing isolated collagen; freezing the isolated collagen; dehydrating the frozen collagen; and maturing the dehydrated collagen. Also disclosed are methods of preparing the modified collagen and uses thereof.

Abstract: In some embodiments, the present invention is a composition, including: a bulking agent, where the bulking agent is a kaolin, an absorbent material, where the absorbent material is a fumed silica, a binder, where the binder is an epoxy, and a first active agent, where the first active agent is Latanoprost.

Abstract: A gel containing hyaluronic acid in a crosslinked form or in a mixture of a crosslinked and non-crosslinked form is injected into the periosteum of a bone in order to heal and/or regenerate bones or tissue surrounding bones in humans or vertebrates.

Abstract: A microsphere is claimed which includes at least one biodegradable polymer and at least one local anesthetic, wherein about 75% of the at least one local anesthetic is released by about 72 hours and from about 80% to about 90% of the at least one local anesthetic is released by about 120 hours, thereby relieving chronic pain for at least 28 days.

Abstract: In certain described embodiments, implantable medical materials comprise a scaffolding material, a liquid organic binder, and entrapped calcium-containing particles. The medical materials can incorporate an osteoinductive factor such as a protein. The scaffolding material can bind the factor. In additional described embodiments, implantable medical materials include an osteoconductive scaffolding material, an incorporated osteoinductive factor, and a biodegradable barrier material effective to delay release of the factor from the scaffolding material. The scaffolding material can bind the factor. Also described a methods for preparing and implanting the described medical materials.

Abstract: The present invention is a surface treated drug-loaded solid (e.g., non-porous) microparticle that aggregates in vivo to form a consolidated larger particle for medical therapy. In one embodiment, the particles are used for ocular therapy. Processes for producing the surface treated microparticle and injectable formulations which include the surface treated microparticle are also provided. When used in the eye, long-term consistent intraocular delivery can be achieved without disrupting vision and minimizing undesirable inflammatory responses.

Abstract: A surgical sealant comprising a first agent containing a hydrophobically-modified gelatin derived from a cold-water fish, and a second agent containing a water-soluble molecule for crosslinking, wherein the water-soluble molecule for crosslinking is at least one kind selected from the group consisting of poly acids and acid anhydrides having two or more active ester groups, and aldehyde compounds having two or more aldehyde groups, the hydrophobically-modified gelatin derived from a cold-water fish is a gelatin in which at least a part of amino groups of side chains of a gelatin derived from a cold-water fish has been substituted by hydrophobic groups, and the hydrophobic groups are linear chain aliphatic groups each having 8 to 18 carbon atoms, with a substitution rate (number of moles of hydrophobic groups/(total number of moles of hydrophobic groups and reactive amino groups in gelatin)×100) of 3 to 20 mol %.

Abstract: The present invention includes biomimetic nerve conduits that can be used as nerve regeneration pathways. The present invention further provides methods of preparing and using biomimetic nerve conduits. The disclosed compositions and methods have a broad range of potential applications, for example replacing a missing or damaged section of a nerve pathway of a mammal.

Abstract: Biocompatible intraocular implants, such as microparticles, include a prostamide component and a biodegradable polymer that is effective in facilitating release of the prostamide component into an eye for an extended period of time. The prostamide component may be associated with a biodegradable polymer matrix, such as a matrix of a two biodegradable polymers. Or, the prostamide component may be encapsulated by the polymeric component. The present implants include oil-in-oil emulsified implants or microparticles. Methods of producing the present implants are also described. The implants may be placed in an eye to treat or reduce a at least one symptom of an ocular condition, such as glaucoma.

Abstract: An injection solution can be used in a pharmaceutical dosage formulation. The injection solution includes an organic solvent, a copolymer, which is a poly(lactide-co-glycolide) dissolved in the organic solvent, and a pharmaceutical active ingredient, which is a non-nucleoside inhibitor of the HIV reverse transcriptase or of the HIV integrase, and which contains aromatic and heterocyclic aromatic or aromatic and heterocyclic aromatic and aliphatic heterocyclic groups, where a content of the pharmaceutical active ingredient is from about 8 to about 25% by weight of the copolymer solution.

Abstract: The present invention encompasses a therapeutic method which employs treatment of a disease such as cancer with triiodothyronine (T3) together with an anti-thyroid treatment such as treatment with an anti-thyroid agent, treatment with radioiodine and surgical removal of all or part of the thyroid gland. A pharmaceutical composition comprising T3 and an anti-thyroid agent and a kit comprising the same are also encompassed by the invention.

Abstract: A vascular assessment apparatus is disclosed. The apparatus is configured to receive medical images of a coronary vessel tree of a subject from a medical imaging device and analyze the medical images to identify vessel segments within the coronary vessel tree. For each identified vessel segment, the apparatus is configured to analyze portions of the segment to determine at least one of a radius, diameter, or cross-sectional area of the vessel segment at the analyzed portions, determine resistances for the analyzed portions of the vessel segment based the radius, diameter, or the cross-sectional area at the analyzed portions, and combine the determined resistances for the analyzed portions of the vessel segment to determine a total resistance of the identified vessel segment. The example apparatus is also configured to determine flow rates at each identified vessel segment and calculate an index indicative of vascular function based on the determined flow rates.

Abstract: Devices, systems, and methods for localized drug delivery. In at least one embodiment of a method of localized drug delivery, the method comprises the steps of placing a resorbable device within a tube, introducing the tube within a mammalian body at or near a tissue and/or organ within the mammalian body, and anchoring the resorbable device to the tissue and/or organ. Devices and systems useful for performing such a method are also disclosed herein, wherein an exemplary device comprises at least one drug release portion having at least one drug to be released over time and a binder intermixed with the at least one drug, and at least one resorbable anchor portion coupled to the at least one drug release portion.

Abstract: A composition includes a target pharmaceutical or biological agent, a solution containing the target pharmaceutical or biological agent, and substrate that is soluble in the solution. The substrate is capable of being solidified via a solidification process and the solidification process causes the substrate to become physically or chemically cross-linked, vitrified, or crystallized. As a result of the solidification process, particles are formed. The target pharmaceutical or biological agent within the solution retains proper conformation to ultimately produce a desired effect.

Abstract: The present invention relates to a new method for producing a calcium sulphate hemihydrate with unique properties for use for therapeutic applications in the cosmetic or pharmaceutical industry. Calcium sulphate hemihydrate is a biocompatible and biodegradable inorganic substance and thus suitable as a carrier in pharmaceutical compositions, e.g. a controlled release composition, containing at least one pharmaceutically active ingredient.

Abstract: Provided is a slow release composition to promote bone growth, the slow release composition comprising: an oxysterol encapsulated in a biodegradable polymer to control the release of the oxysterol. Methods of making and use are further provided.

Abstract: An implantable hydrogel precursor composition can include: a cross-linkable polymer matrix that is biocompatible; and a plurality of polymer particles in the cross-linkable polymer matrix. The cross-linkable polymer matrix can include a cross-linkable hyaluronic acid polymer that has cross-linkable functional groups. The hyaluronic acid polymer can be a methacrylated hyaluronic acid polymer. The methacrylated hyaluronic acid polymer can have a molecular weight from about 500 kDa to about 1.8 MDa. The polymer particles can include a cross-linked hyaluronic acid. The cross-linkable polymer matrix having the polymer particles has a yield stress. The cross-linkable polymer matrix having the polymer particles has shape retention at physiological temperatures. The composition can include live cells in the cross-linkable polymer matrix. The composition can include a biologically active agent in the cross-linkable polymer matrix.

Abstract: The present disclosure provides a controlled release composition comprising a plurality of microparticles and a matrix, wherein: the plurality of microparticles comprises a first material; the matrix comprises a second material; and the melting temperature of the first material is higher than the melting temperature of the second material. Also provided are methods of making and using the same.

Abstract: The disclosure relates to a cyclic carbonate monomer containing double iodine, a biodegradable polymer prepared thereby and use. The polymer can be obtained by ring-opening polymerization of the cyclic carbonate monomer containing double iodine, without affecting the ring-opening polymerization and without a protection and deprotection process. The polymer which is obtained by ring-opening polymerization of the cyclic carbonate monomer of the present disclosure can be assembled into a nano-vesicle and a micelle as a drug carrier, a biological tissue scaffold or a CT contrast media.

Abstract: Devices and methods for brachytherapy treatment are disclosed. One aspect is a poly(methyl methacrylate) apparatus for brachytherapy treatment at the vaginal apex. Another aspect is a poly(methyl methacrylate) apparatus for brachytherapy treatment in the distal two-thirds of the vagina. Another aspect is a poly(methyl methacrylate) apparatus for brachytherapy treatment of cancers that are offset from the vaginal apex. Other aspects include methods for guiding needles for treatment of cancers at the vaginal apex, in the distal two-thirds of the vagina, and that are offset from the vaginal apex.

Abstract: A resorbable crosslinked form stable membrane containing a composite layer of collagen material and inorganic ceramic particles containing 1.5 to 3.5 weight parts of inorganic ceramic for 1 weight part of collagen material, sandwiched between two layers of elastic pretensed collagen material, wherein the elastic pretensed collagen material is collagen material that has been stretched such as to be in the linear/elastic region of the stress-strain curve, the collagen material comprising 50-100% (w/w) collagen and 0-50% (w/w) elastin.

Abstract: Provided herein are magnetic resonance imaging (MRI) contrast agents comprising a compound having a structure represented by: Y—X—Z, wherein, X is: Fe(III) or Mn(II), and Y and Z are each independently selected from pyrophosphate and bisphosphonate (e.g., 1-hydroxybisphosphonate), or a pharmaceutically acceptable hydrate and/or salt thereof. Methods of use of the MRI contrast agent are also provided.