Abstract: Effective treatments of dystonia and/or post-stroke spasticity for extended periods of time are provided. Through the administration of an effective amount of clonidine at or near a target site, one can relieve dystonia and/or post-stroke spasticity caused by diverse sources. When appropriate formulations are provided within biodegradable polymers, this relief can be continued for at least five days. In some embodiments, the relief can be for at least twenty-five days, at least fifty days, at least one hundred days, at least one hundred and thirty-five days or at least one hundred and eighty days.

Abstract: The present invention relates to methods for the treatment of hepatic disorders in a subject in need thereof. More specifically, the methods of the invention are based on the administration, preferably, systemic administration, of a therapeutically effective amount of at least one biocompatible alginate biomaterial, any modification thereof and any combination thereof. The invention further provides methods for sustaining serum albumin levels, and/or reducing serum AST and ALT, in subjects suffering from hepatic disorder. Still further, the invention provides methods for reducing apoptosis and inducing cell proliferation in a damaged liver tissue of a subject suffering of hepatic disorder, using the alginate biomaterial described by the invention.

Abstract: Embodiments of the present disclosure comprise occlusion and drug delivery devices and methods. One aspect of the disclosure comprises a drug delivery device comprising an inner expansion member and an outer drug delivery component. Another aspect of the disclosure comprises bioabsorbable, lumen-occluding implants.

Abstract: Synthetic, bioactive ultra-porous bone graft materials having an engineered porosity, and implants formed from such materials are provided. In particular, these implants comprise bioactive glass and incorporate allograft material for osteoinduction. The implants are suitable for bone tissue regeneration and/or repair.

Abstract: Amphiphilic triblock copolymers B-A-B, wherein A is a linear poly(ethylene glycol) block, having a number average molecular weight (Mn) of between 900 and 3000 Daltons, determined with size exclusion chromatography; wherein B are hydrophobic blocks with at least two cyclic monomers selected from the group consisting of glycolide, lactide, 1,3-dioxan-2-one, 5,5-dimethyl-1,3-dioxan-2-one, 1,4-dioxan-2-one, 1,4-dioxepan-2-one, 1,5-dioxepan-2-one, each B-block having a number average molecular weight (Mn) of between 400 and 2000 Daltons, determined with size exclusion chromatography; and wherein 25% to 100% of the polymer hydroxyl end-groups are covalently modified with at least one derivative of a C2-C20 fatty acid. The invention also relates to compositions with such polymers and the use thereof.

Abstract: The described invention provides a flowable sustained release microparticulate composition, a kit for treating at least one cerebral artery in a subarachnoid space at risk of interruption due to a brain injury, a method of preparing the composition, and a method for treating an interruption of a cerebral artery in a subarachnoid space at risk of interruption caused by brain injury in a mammal, which reduces signs or symptoms of at least one delayed complication associated with brain injury.

Abstract: The present invention provides a pharmaceutical composition capable of forming in-situ implant comprising goserelin or its pharmaceutically acceptable salts thereof, biodegradable polymer and a biocompatible organic solvent wherein the biocompatible organic solvent is miscible to dispersible in aqueous medium or body fluid. The present invention further provides a process for the preparation of pharmaceutical composition capable of forming in-situ implant. A kit containing composition for in-situ implant is provided comprising a first vial comprising a composition comprising a biodegradable polymer and a biocompatible organic solvent; wherein the biocompatible organic solvent is miscible to dispersible in aqueous medium or body fluid; and a second vial comprising goserelin acetate.

Abstract: Methods for more uniformly delivering drugs or other treatment agents locally to the vasculature of a mammal are disclosed. These methods use one or more strategies to facilitate rapid mixing with the blood flowing past a device or otherwise improve the uniformity of drug delivery. Some of these strategies employ medical devices with diffusion members.

Abstract: The present invention provides a drug eluting surgical screw and a method for manufacturing a drug eluting surgical screw. The drug eluting surgical screw may include a shaft having a threaded portion, a head having a drive recess disposed at a proximal end of the shaft, the drive recess having a reservoir region and a driver engagement region, and at least one or more drug eluting components disposed within the reservoir region of the drive recess in a manner that does not substantially impair a connection between a driver and the surgical screw when the driver is operably disposed within the driver engagement region, each of the at least one or more drug eluting components including a carrier matrix and a therapeutic agent, the therapeutic agent being at least 20 wt % of the drug eluting component prior to any implantation of the drug eluting surgical screw.

Abstract: This invention relates to deployable hemostatic materials comprising chitosan fibers. The hemostatic materials are suitable for use in sealing or controlling active bleeding from artery and vein lacerations and punctures, and for controlling oozing from tissue.

Abstract: The invention is directed to biodegradable, thermoplastic, phase separated segmented multi-block copolymers. The copolymers of the present invention find use in various biomedical applications as well as in pharmaceutical applications. Provided is a composition for the controlled release of at least one biologically active polypeptide to a host, comprising the at least one biologically active polypeptide encapsulated in a matrix comprising at least one phase separated, thermoplastic multi-block copolymer, the copolymer being characterized in that (i) it comprises at least two hydrolysable segments chosen from prepolymer (A) and prepolymer (B), prepolymer (A) having a Tg lower than 37° C. and prepolymer (B) having a Tm of 40° C.-100° C. under physiological conditions; (ii) the segments being linked by a multifunctional chain-extender; (iii) the segments are randomly distributed over the polymer chain; and (iv) prepolymer (A) contains a segment that is derived from a water soluble polymer.

Abstract: An implantable drug depot useful for preventing, reducing or treating bleeding at a surgical site beneath the skin in a patient is provided. The implantable drug depot comprises a therapeutically effective amount of clonidine or a pharmaceutically acceptable salt thereof, and at least one biodegradable polymer. The drug depot is capable of releasing clonidine or a pharmaceutically acceptable salt thereof over a period of at least three days.

Abstract: The present invention relates to a crosslinked gelatin support, in which a surface of a crosslinked gelatin is negatively charged and has a zeta potential in ethanol of from ?3 to ?50 mV, and a support for controlled release of a physiologically active substance, including: the crosslinked gelatin support; and a physiologically active substance adsorbed and retained on and/or inside the crosslinked gelatin support.

Abstract: The present invention provides an implantable device having a coating including a slow dissolving polymer or material and the methods of making and using the same.

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: Pharmaceutical gels and methods for delivering a therapeutic agent to a target tissue site beneath the skin of a patient are provided, the gel being capable of adhering to the target tissue site and comprising one or more biodegradable depots containing an effective amount of the therapeutic agent. In various embodiments, the gel is sprayable and hardens after contacting the target tissue site.

Abstract: Described is a medically useful article comprising a three-dimensional body including one or more implantable substances, wherein the body defines one or more reservoirs for receiving amounts of a biocompatible wetting liquid. In certain embodiments the body is disruptable upon wetting with the biocompatible liquid to form a conformable implantable material such as a putty, paste or more flowable wetted implant material. Also described are methods for manufacturing such medical materials, and methods for using such medical materials to treat patients.

Abstract: A porous implant matrix consists mainly of a mixture of polymers which are differently rapidly degradable, wherein nominal resorption times of two of the components of the mixture, each accounting for at least 10% of the mixture, differ by a factor of at least 5. The porous implant matrix is manufactured from a mixture of the at least two differently rapidly degradable polymers, wherein particles of both polymers are mixed with particles of a water-soluble solid and a solvent for one of the polymers, and after evaporating the solvent is optionally compacted, and the solid is removed by watering.

Abstract: An aqueous composition with a higher-than-neutral pH includes a significant amount of one or more surfactants and large amounts of osmotically active solutes. This composition, as well as an acidic counterpart and solid materials, can be used in a variety of applications such as wound care, oral care, medical equipment reprocessing, healthcare acquired infection and implant treatment.

Abstract: Compositions of P4HB (poly-4-hydroxybutyrate) and copolymers thereof, have been developed for pultrusion, as well as processes to produce profiles from these compositions by pultrusion. These pultrusion processes provide profiles without causing structural damage to the surface of the profile. The profiles may be used in medical applications. These compositions include P4HB, and copolymers thereof, having intrinsic viscosities less than 3.2 dl/g but greater than 0.8 dl/g. The profile may be formed using conditions such as: pull rate of 0.1 to 100 mm/min, die temperature of up to 95° C., rod stock temperature up to 95° C., draw ratio of up to 100×, pulling force of greater than 10 MPa, and clamping pressure at least 10% higher than the pulling force. Preferably, the profile is formed by pulling the rod stock through a series of dies placed at intervals with the hole sizes decreasing in diameter by 0.1 to 10 mm.

Abstract: Effective treatments of pain for extended periods of time are provided. Through the administration of an effective amount of clonidine and a gamma-aminobutyric acid compound at or near a target site, one can relieve pain caused by diverse sources, including but not limited to spinal disc herniation (i.e. sciatica), spondilothesis, stenosis, discogenic back pain and joint pain, as well as pain that is incidental to surgery. When appropriate formulations are provided within biodegradable polymers, this relief can be continued for at least three days. In some embodiments, the relief can be for at least twenty-five days, at least fifty days, at least one hundred days, at least one hundred and thirty-five days or at least one hundred and eighty days.

Abstract: An assembly for an implantable device can be made from PEEK and can incorporate one or more radiopaque agents and one or more elutable drug components into a polymeric lead tip. The assembly can be machined or injection molded and can be configured, for example, as a housing for an active fixation lead or as an electrode base supporting a foil electrode.

Abstract: A method for forming a material in an in situ medical device by initiating polymerization of water soluble polymer precursors in an aqueous solution during or after transport of the polymerizable solution from its storage container to a space inside the in situ medical device is described. The stored aqueous solution with water soluble precursors lacks a free radical initiator which, in a powder form, is introduced into the aqueous solution during or after its transport into the space inside the in situ medical device. This storage and delivery system provides greater stability to the stored aqueous solution, allowing it to be stored at ambient temperature and providing extended shelf life over the solutions used in existing in situ polymerization systems. The flexibility to store and deliver/transport only one aqueous solution, instead of requiring the use of two different solutions, is also a benefit.

Abstract: Disclosed is a dry composition, which upon addition of an aqueous medium forms a substantially homogenous paste suitable for use in haemostasis procedures. The paste forms spontaneously upon addition of the liquid, hence no mechanical mixing is required for said paste to form. Further disclosed are methods of preparing said dry composition, a paste made from said dry composition and use of said paste for medical and surgical purposes.

Abstract: Novel absorbable polymeric blends made from components wherein at least one of the components is synthesized using mixtures of mono- and di-functional initiators are disclosed. The blends have a first component that is a polylactide polymer or a copolymer of lactide and glycolide and a second component that is either poly(p-dioxanone) homopolymer, or a poly(p-dioxanone-co-glycolide) copolymer. The novel polymeric blends provide medical devices having dimensional stability. Also disclosed are novel absorbable medical devices made from these novel polymer blends, as well as novel methods of manufacture.

Abstract: The present invention relates to compositions and methods for tissue regeneration, particularly for treating skin lesions such as wounds. In one aspect, the invention provides wound healing composition characterized by the higher expression levels of phenotypic marker genes such as apolipoprotein D, matrix metalloprotease (2), collagen 3a1 and smooth muscle actin than the housekeeping gene ribosomal protein L32. The compositions and methods of the invention are useful especially for assisting the process of wound healing, particularly chronic open lesions that are slow to heal or resistant to healing.

Abstract: A composition for chemoembolotherapy of solid tumors comprises particles of a water-insoluble water-swellable synthetic anionic polymer and, absorbed therein an anthracycline. Suitably the polymer is a poly(vinyl alcohol) based polymer and the drug is doxorubicin.

Abstract: Disclosed is a method for producing resin particles, which can impart a desired function to the surface of resin particles efficiently and simply. Also disclosed are resin particles produced by the method. The method produces resin particles by melting and mixing an acidic-group-containing thermoplastic resin or elastomer with filler particles and a water-soluble material to give a resin composition containing resin fine particles formed by the thermoplastic resin and the filler particles and dispersed in a matrix including the water-soluble material; and removing the matrix component from the resin composition, to give the resin particles. The resulting resin particles each include a core particle including the acidic-group-containing thermoplastic resin or elastomer, and the filler particles immobilized on the outside of the core particle. The acidic group is preferably carboxyl group or carboxylic anhydride group.

Abstract: The present invention is directed to methods of reducing symptoms associated with an abrupt reduction in an endogenous or exogenous chemical in subjects, the methods comprising: (a) administering to the subject a single dosage form comprising an active agent, wherein the release rate of the active agent from the single dosage form tapers throughout the administration; and (b) removing the single dosage form from the subjects after the release rate of the active agent is at or below a terminal symptom threshold level.

Abstract: Compositions and methods of making and using of microparticle compositions that provide faster flow or improved injectability through smaller or small-diameter needles have been developed. Notably, the microparticle compositions can be successfully delivered or administered through smaller-diameter needles than other microparticle compositions prepared from biocompatible or biodegradable polymers including, for example, poly(lactide), poly(lactide-co-glycolide), polycaprolactone, or poly-3-hydroxybutyrate. The microparticle compositions can exhibit a higher solids loading for a given needle size and/or faster flow through needles than other microparticle compositions. Further, blending or mixing the polymer of the microparticle composition with other polymer formulations can enhance the injectability of the resulting formulation.

Abstract: A medical device includes a substrate having at least one surface. The surface has a central portion and a peripheral portion. At least one bioactive agent is disposed over at least a portion of the surface. The medical device having a concentration gradient of the at least one bioactive between the central and peripheral portions.

Abstract: A porous silicon implant impregnated with a beneficial substance, such as a micromineral required for healthy physiology, is implanted subcutaneously and is entirely corroded away over the following months/year to release the beneficial substance in a controlled manner. In a second embodiment the implant may have a large number of holes which contain beneficial substance and which are closed by bio-erodible doors of different thickness so as to stagger the release of the beneficial substance over time as the doors are breached.

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: The present invention provides administration methods for CDPC for treating stroke. CDPC was delivered via ECS at a concentration of 40 mmol/L-60 mmol/L. In a specific embodiment of the present invention, the concentration of CDPC administered is 50 mmol/L, CDPC is delivered at one time, the flow rate of administration is 0.2 ?L/min, the volume of CDPC is 1.33 ?L/mL of brain tissue, and the CDPC is administered in the caudate nucleus. The method can decrease the concentration of CDPC entering the brain and further decrease the dosage while improving efficacy. Thus, the result is improved and the probability of adverse effects due to the drug is reduced.

Abstract: In one aspect, the subject matter disclosed herein is directed to NO-releasing functionalized nanorods having a desirable aspect ratio. The nanorods are also capable of releasing a desirable amount of NO (nitric oxide). In another aspect, the subject matter disclosed herein is directed to a composition comprising the NO-releasing nanorods. In another aspect, the subject matter disclosed herein is directed to methods of preparing NO-releasing nanorods having a specified aspect ratio. In another aspect, the subject matter disclosed herein is directed to a method of combating infection comprising administering to a subject a composition comprising NO-releasing nanorods, wherein the nanorods have a specified aspect ratio and NO-release profile.

Abstract: Nano-fibrous microspheres and methods for forming them are disclosed herein. In one embodiment the microsphere includes a plurality of nano-fibers aggregated together in a spherical shape; and a plurality of pores formed between at least some of the plurality of nano-fibers. The nano-fibers are formed of star-shaped polymers.

Abstract: The present invention relates to a risperidone sustained release delivery system for treatment of medical conditions relating delusional psychosis, schizophrenia, bipolar disorder, psychotic depression, obsessive-compulsion disorder, Tourette syndrome, and autistic spectrum disorders. The sustained release delivery system includes a flowable composition containing risperidone, a metabolite, or a prodrug thereof and an implant containing risperidone, a metabolite, or a prodrug thereof. The flowable composition may be injected into tissue whereupon it coagulates to become the solid or gel, monolithic implant. The flowable composition includes a biodegradable, thermoplastic polymer, an organic liquid, and risperidone, a metabolite, or a prodrug thereof.

Abstract: Novel bioabsorbable polymeric blends are disclosed. The blends have a first component that is a polylactide polymer or a copolymer of lactide and glycolide and a second component that is poly(p-dioxanone) polymer. The novel polymeric blends provide medical devices having dimensional stability. Also disclosed are novel bioabsorbable medical devices made from these novel polymer blends, as well as novel methods of manufacture.

Abstract: Amphiphilic triblock copolymers B-A-B, wherein A is a linear poly(ethylene glycol) block, having a number average molecular weight (Mn) of between 900 and 3000 Daltons, determined with size exclusion chromatography; wherein B are hydrophobic blocks with at least two cyclic monomers selected from the group consisting of glycolide, lactide, 1,3-dioxan-2-one, 5,5-dimethyl-1,3-dioxan-2-one, 1,4-dioxan-2-one, 1,4-dioxepan-2-one, 1,5-dioxepan-2-one, each B-block having a number average molecular weight (Mn) of between 400 and 2000 Daltons, determined with size exclusion chromatography; and wherein 25% to 100% of the polymer hydroxyl end-groups are covalently modified with at least one derivative of a C2-C20 fatty acid. The invention also relates to compositions with such polymers and the use thereof.

Abstract: Biodegradable and bioabsorbable block copolymers, which can be in the form of solid powder or powder wax compositions that can be easily reconstituted into an aqueous polymer solution and exhibit reverse thermal gellation properties upon exposure to elevated temperatures, are provided. Methods of making using these copolymers are also provided.

Abstract: The present invention provides an improved technique for spinal fusion involving the administration of an HMG-CoA reductase inhibitor to a fusion. The HMG-CoA reductase inhibitor is preferably delivered to the site by a carrier. More preferably, the HMG-CoA reductase inhibitor is delivered to the site by a non-compressible delivery vehicle. The invention is suitable for promoting non-anatomic or heterotopic bone growth between any bony surfaces where bone growth is desired but does not naturally occur.

Abstract: Ceramic/structural protein composite scaffolds and their preparation in a simple one-step process are shown.

Abstract: Effective methods of treating back pain from an intervertebral disc are provided. The methods of treatment include administering an immediate release analgesic at or near the intervertebral disc; administering a bulking agent or sealing agent within the intervertebral disc; and administering a sustained release analgesic within the intervertebral disc, wherein the sustained release analgesic releases the analgesic over a period of at least one day.

Abstract: The present invention relates to A bioresorbable implant comprising: a bioresorbable porous layer including a biopolymer foam and defining first pores, a bioresorbable porous three-dimensional mesh made from a microbial cellulose and defining second pores, wherein the bioresorbable porous layer is disposed in the bioresorbable porous three-dimensional mesh. The invention also relates to a method of making a bioresorbable implant.

Abstract: The present invention relates to an implant comprising at least two layers made of fibers and bioactive material arranged between said at least two layers, the bioactive material being selected from the group consisting of bioactive glass, hydroxyapatite, tricalciumphosphate and mixtures thereof. In the implant, at least one of the layers is at least mainly formed of a mesh, which is made of glass fibers having a diameter of 3-100 ?m, and wherein the mesh size is selected such that the bioactive material is retained within the implant. In addition, the layers are embedded in a matrix made of a resin selected from the group consisting of polyesters, epoxies, acrylates and mixtures thereof, and the layers are attached to each other along the contour of the implant.

Abstract: A device releases a fluid active substance, the device has at least one hollow space containing the fluid active substance, whereby the device contains water and a reducing agent, which are or can be made to be in communication such that a chemical reaction of the water and the reducing agent produces a gas and the gas effectively communicates with the fluid active substance such that the gas pressure thus generated presses the fluid active substance out of at least one opening of the hollow space out of the device. A medical implant incorporates the device, and a method releases a fluid active substance from a hollow space of the medical implant, in which a gas is produced through a chemical reaction of liquid water and a reducing agent, and the resulting gas pressure is used to expel the fluid active substance out of at least one opening of the hollow space.

Abstract: An osteoimplant includes at least partially demineralized cancellous bone as a substrate, which is impregnated with demineralized cortical bone matrix (DBM). The implant may include a binding agent to adhere the DBM to the cancellous bone substrate, and may also include a soft tissue barrier that covers a portion of the external surface of the implant. The cancellous bone substrate may be selectively demineralized, so as to provide regions with greater malleability, and other regions with greater structural properties.

Abstract: A therapeutic device to release a therapeutic agent comprises a porous structure coupled to a container comprising a reservoir. The reservoir comprises a volume sized to release therapeutic amounts of the therapeutic agent for an extended time when coupled to the porous structure and implanted in the patient. The porous structure may comprise a first side coupled to the reservoir and a second side to couple to the patient to release the therapeutic agent. The length of the channels extending from the first side to the second side may comprise an effective length greater than a distance across the porous structure from the first side to the second side. The therapeutic device may comprise a penetrable barrier to inject therapeutic agent into the device when implanted in the patient.

Abstract: Effective methods of treating a spinal disorder or osteoarthritis associated with a proinflammatory agent in a patient in need of such treatment, the method comprising administering an effective amount of DN-TNF (e.g., XPro®-1595) to a target tissue site at or near the spine or osteoarthritic joint to reduce pain and/or inflammation.

Abstract: Medical articles with porous polymeric structures and methods of forming thereof are disclosed. The porous structure can have pores sizes that are nanoporous or greater than nanoporous. The porous structure can be a coating or layer of a medical device such as a stent, stent graft, catheter, or lead for pacemakers or implantable cardioverter defibrillators. Additionally, the body of the medical device can be a porous polymeric structure. The porous structure can be made from bioabsorbable polymers. The porous structures can be formed by contacting a polymer with a supercritical fluid.