Abstract: A balloon catheter is disclosed that can effectively deliver a drug to living body tissue, a method of manufacturing a balloon catheter, and a treatment method. A balloon catheter is disclosed, the balloon catheter is provided on an outer surface of a balloon with a plurality of elongate bodies which are independent crystals of a water-insoluble drug extending in an elongate form. The elongate bodies include fixed-side elongate bodies which are fixed to the outer surface side of the balloon, and top-side elongate bodies which are bent or broken from the fixed-side elongate bodies and are continuous with or independent of the fixed-side elongate bodies.

Abstract: Various examples of systems and methods for making microspheres, microparticles, and emulsions are provided. In one example, a system and method for forming microspheres comprises: pumping a dispersed phase liquid and a continuous phase liquid into a levitating magnetic impeller pump to subject the dispersed phase liquid and continuous phase liquid to a high shear environment within the impeller pump's pump chamber. In another example, a system and method for forming an emulsion comprises: pumping a dispersed phase liquid and an inner aqueous phase liquid into a levitating magnetic impeller pump to subject the dispersed phase and the inner aqueous phase to a high shear environment within the impeller pump's pump chamber.

Abstract: A solubilized notochordal cell matrix powder dissolved in a carrier solvent or formed as a gel is provided. The notochordal cell matrix powder originates from lyophilized and treated porcine nucleus pulposus tissue containing notochordal cells. The powder contains less than 20% of porcine nucleid acids, and the powder contains a substantially unchanged amount of porcine protein content compared to the originating porcine nucleus pulposus tissue. The solubilized notochordal cell matrix powder is capable of stimulating native or stem cells to proliferate and produce a significant increase inglycosaminoglycansand type-II collagen matrix. Embodiments of the invention can be used for the disc regenerative treatment of discogenic back and neck pain in an orthopaedic and/or pharmaceutical setting/approach.

Abstract: The present invention provides an improved process for preparing microparticles containing glatiramer acetate having low levels of residual organic solvent(s), in particular dichloromethane. The microparticles are incorporated into long acting parenteral pharmaceutical compositions in depot form that are suitable for subcutaneous or intramuscular implantation or injection, and that may be used to treat multiple sclerosis.

Abstract: A balloon catheter by which a drug can be effectively delivered to living body tissue and a method of manufacturing the balloon catheter, and a treatment method. The balloon catheter is provided on an outer surface of a balloon with a plurality of elongate bodies which are independent crystals of a water-insoluble drug that extend in an elongate form. The elongate bodies have long axes extending in directions along the outer surface of the balloon when the balloon is in a deflated state. Deformation, when the balloon is inflated from the deflated state, of portions on an outer surface side of the balloon to which end portions of the elongate bodies are fixed causes a force to act on the elongate bodies such that the long axes of the elongate bodies approach perpendicularity to the outer surface of the balloon.

Abstract: A therapeutic device for extended release drug delivery including a refillable reservoir configured to receive a therapeutic agent and having an outlet for delivery of the therapeutic agent to a patient from the reservoir over an extended period. A porous structure is coupled near the outlet of the reservoir, the porous structure formed of sintered material. A barrier layer is coupled to the reservoir on or adjacent a surface of the porous structure such that the therapeutic agent passes through both the porous structure and the barrier layer upon delivery from the reservoir through the outlet. The porous structure is tuned to deliver the therapeutic agent at a diffusion rate and the barrier layer is adapted to block passage of particles having an average particle size within an average particle size range that is outside an average particle size range blocked by the porous structure. Related methods and systems are provided.

Abstract: A balloon catheter includes an elongated main body extending in an axial direction and a balloon connected to the elongated main body. The balloon is inflatable and deflatable in the radial direction. The outer surface of the balloon includes a plurality of recesses that are spaced apart from one another. The balloon catheter also includes a plurality of elongate bodies on the outer surface of the balloon. The elongate bodies are crystals of a water-insoluble drug extending in the radial direction of the balloon away from the interior of the balloon. The elongate bodies each possess an independent long axis. At least two elongate bodies of the elongate bodies are positioned in one of the recesses in the outer surface of the balloon. These two elongate bodies extend from within the recess to a surrounding environment in the radial direction of the balloon.

Abstract: A drug delivery system is provided in the form of a controlled release, bioerodible pellet for subdermal implantation. The pellet is bioerodible, and provides for the sustained release of a pharmacologically active agent over an extended time period. As such, the drug delivery system finds significant utility in chronic drug administration. Bioerosion products are water soluble, bioresorbed, or both, obviating the need for surgical removal of the implant. Methods for manufacturing and using the drug delivery system are also provided.

Abstract: A staple cartridge is disclosed. The staple cartridge can include a cartridge body, a plurality of staples, and an implantable layer. The implantable layer can include a piece of lyophilized foam and a plurality of fibers at least partially embedded in the piece of lyophilized foam. The implantable layer can further include a plurality of pores defined in piece of lyophilized foam, and a plurality of pockets, wherein a pocket at least partially surrounds a fiber. A method of forming an implantable layer for use with a surgical staple is also disclosed. The method can comprise obtaining a mold comprising a cavity, placing a plurality of fibers in the cavity of the mold, dispensing a solution into the cavity around the fibers, and lyophilizing the solution in the cavity.

Abstract: A tissue thickness compensator comprising a first compensation layer, a second compensation layer, and a pocket situated between the compensation layers can be positioned in the end effector of a surgical instrument. A fastener cartridge positioned in the end effector can comprise a fastener moveable between an initial position and a fired position. When the fastener is moved from the initial position to the fired position, the fastener can move through the pocket and can compress a portion of the tissue thickness compensator. A support can be positioned between the first and second compensation layers. When the fastener compresses the tissue thickness compensator, at least one of the support, first compensation layer and second compensation layer can be deformed. The tissue thickness compensator can also comprise a tab and/or a limiting plate to control deformation of the compensation layers and/or the support.

Abstract: The present invention relates to a biocompatible nanoparticle and a use thereof and, more specifically, to a biocompatible nanoparticle formed by irradiation an electron beam to an aqueous solution comprising at least one substance selected from the group consisting of a polysaccharide, a derivative thereof and a polyethylene glycol, thereby inducing inter-molecular cross-linking or intra-molecular cross-linking, and to a use of the biocompatible nanoparticle in a drug carrier, a contrast agent, a diagnostic agent or an intestinal adhesion prevention agent or for disease prevention and treatment.

Abstract: A core-shell gel particle of the invention contains a crosslinked hyaluronic acid, has a higher equilibrium swelling capacity at the surface than at the center, the equilibrium swelling capacity showing a change curve with an inflection point from the center to the surface, and has a probe pushing force of 20 nN or less from the surface to a depth of 800 nm.

Abstract: Absorbable barrier composites are designed for modulated gas and water permeability depending on clinical use and are formed of at least two physicochemically distinct components, one of which is a film adjoined to a knitted mesh and/or electrostatically spun, non-woven fabric. Depending on the physicochemical properties of the barrier composite, it can be used in neurological and urinogenital surgical procedures as well as tissue engineering and/or as physical barriers to prevent adhesion formation following several types of surgical procedures.

Abstract: A medical sampling device, a method of manufacturing the device, and methods of testing and diagnosis using the device; a sampling dressing comprising the device, a method of manufacturing the dressing, and a method of diagnosis using the dressing; and a therapy dressing comprising the device, a method of manufacturing the dressing, and a method of treatment using the dressing. The a sampling device comprises a biodegradable porous scaffold which in use lies in contact with tissue to be sampled and comprises a fluid, in particular a reversibly thermoswitchable gel.

Abstract: The invention provides a drug delivery system for a combination of therapeutic agents. The system includes a water soluble biodegradable ABA-type triblock copolymer that possesses thermosensitive gelation properties. The system can form a stable thermogel that includes a combination of therapeutic agents including, for example, rapamycin, paclitaxel, and 17-AAG. After administration to a subject, the drugs are released at a controlled rate from the thermogel, which biodegrades into non-toxic components. The polymer system can also function to increase the solubility and stability of drugs in the composition.

Abstract: The invention provides compositions and methods for treatment of tendon and ligament injuries and/or repair of damaged tendons and ligament. The invention provides compositions comprising a biocompatible matrix and platelet-derived growth factor (PDGF).

Abstract: The invention discloses naltrexone implantable tablets which are devoid of metal salts and corticosteroids, and which provide consistent and controlled amount of naltrexone for 3 months or more; also disclosed is methods of treatment comprising the implants and methods of sterilization of the implants.

Abstract: The present invention provides compositions and methods for attaching tendon to bone. The present invention provides compositions and methods for treating rotator cuff injuries. In one embodiment, a method for treating rotator cuff injuries comprises providing a composition comprising PDGF disposed in a biocompatible matrix and applying the composition to at least one site of tendon reattachment on the humeral head.

Abstract: Block copolymer nanostructures such as nanosheets, nanoribbons, and nanotubes, are provided. The nanotructures are formed by the self-assembly of block copolymers during evaporation of solvent from a sol that has been “disturbed”, either i) internally by the introduction of relief (e.g. curvature) and/or the inclusion of nanoparticles in the sol; or ii) externally, e.g. by physical deformation of a semi-solid form of the sol, or a combination of internal and external disturbance. The nanostructures have uses in, for example, energy devices, electronics, sensors and drug delivery applications.

Abstract: Disclosed are compositions that comprise an organic electrochemical mediator and a gasotransmitter salt which converts into a gasotransmitter via electron transfer. Also disclosed are bandages and wound dressings comprising the subject gasotransmitters, and methods of making a gasotransmitters, comprising exposing the compositions to a voltage sufficient to reduce the water soluble organic mediator. Further disclosed are methods of treating a variety of trauma and disease states by applying a therapeutically effective amount of at least one gasotransmitter thereto, and methods of generating an effective dose of the gasotransmitter generated from electrolytic reaction involving the gasotransmitter-generating compositions.

Abstract: Provided is a self-restoring macromolecular material that not only has excellent stress relaxation but that can also be easily restored to its original state, even when damaged or severed. Also provided is a method for producing the self-restoring macromolecular material. The self-restoring macromolecular material contains a crosslinked structure that is formed by crosslinking a polymer containing at least a polyrotaxane molecule. The polyrotaxane molecule is formed so as to include a cyclic molecule 21 and a linear molecule that passes through an opening 21a of the cyclic molecule. The crosslinked structure 1 is crosslinked via a reversible bond between the cyclic molecule of the polyrotaxane molecule and a polymer molecule other than the polyrotaxane molecule.

Abstract: The present invention relates to a method of producing a collagen membrane that has particular mechanical properties.

Abstract: Composite grafts including a biocompatible, synthetic scaffold; and a biological tissue component obtained or derived from a deceased donor tissue, wherein the biological tissue component is embedded in the biocompatible, synthetic scaffold, are provided as systems relating thereto. Methods of manufacture and methods of treatment using such grafts are also provided.

Abstract: Some aspects of this disclosure relate to a method of treating an ophthalmic disease affecting an eye of a patient comprising forming a covalently-crosslinked hydrogel for controlled release of a therapeutic agent.

Abstract: Disclosed are composites comprising water-soluble polymeric fibers dispersed in a biodegradable polymer matrix, as well as methods of making and using such composites.

Abstract: The disclosure describes collagen constructs comprising anticancer agents, preferably, platinum, and related methods.

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

Abstract: The present invention encompasses an antithrombotic nanoparticle and use thereof.

Abstract: The invention relates to an anti-inflammatory composition comprising: 53 wt.-% maltodextrin in relation to the total weight; 10-12 wt.-% zinc oxide as a thixotropic agent; 1.8 wt.-% maltose; 0.0002 wt.-% sodium; 0.0002 wt.-% potassium; 0.0002 wt.-% calcium; 0.0002 wt.-% phosphor; and 0.0006 wt.-% magnesium. The composition has an application viscosity in the range of 12,000-33,000 cp, a pH of between 5.6 and 6.9, a TGA of 61.12 and bond strength at 24 hours of 6 MPa.

Abstract: In various embodiments, the present application teaches methods and compositions for tissue clearing in which whole organs and bodies are rendered macromolecule-permeable and optically-transparent, thereby exposing their cellular structure with intact connectivity. In some embodiments, the present application teaches PACT, a protocol for passive tissue clearing and immunostaining of intact organs. In other embodiments, the present application teaches RIMS, a refractive index matching media for imaging thick tissue. In yet other embodiments, the application teaches PARS, a method for whole-body clearing and immunolabeling.

Abstract: Two siloxane-based mixtures combine to form a soft or semi-solid matrix for forming an artificial blockage to control bleeding, particularly moderate to severe bleeding. The first component includes a homogeneous mixture or solution that includes a polymeric matrix, a surfactant, filler(s) and metal compound(s). The second component includes a homogeneous mixture or solution that includes a polymer(s), a filler(s), a surfactant, and hydrogen peroxide. The combination of the two components is carried out with adequate mixing using mechanical and micro-kinetic mixing mechanisms and can be performed in a field-ready delivery device.

Abstract: The present disclosure describes an implant for tissue replacement or augmentation including a resorbable non-pyrogenic porous body of irradiated oxidized cellulose, formed from a precursor reactive mixture of irradiated cellulose and an oxidizing agent, where the body forms a heterogeneous three-dimensional fibrillar network. Also disclosed is a method for producing a body of oxidized cellulose including irradiating a body of cellulose to form an irradiated body of cellulose, and reacting the irradiated body of cellulose with an oxidizing agent to form a non-pyrogenic porous and resorbable body of oxidized cellulose.

Abstract: A stent is formed by encasing or encapsulating metallic rings in an inner polymeric layer and an outer polymeric layer. At least one polymer link connects adjacent metallic rings. The stent is drug loaded with one or more therapeutic agent or drug, for example, to reduce the likelihood of the development of restenosis in the coronary arteries. The inner and outer polymeric materials can be of the same polymer or different polymer to achieve different results, such as enhancing flexibility and providing a stent that is visible under MRI, computer tomography and x-ray fluoroscopy.

Abstract: Delivery systems and compositions comprised of a biodegradable polyorthoester polymer, an aprotic solvent, and a drug are described. The solvent is selected to modulate release of drug from the composition, where, in some embodiments, the solvent is rapidly released after administration and provides a corresponding rapid rate of drug release. Alternatively, in other embodiments, the solvent is slowly released from the composition after its administration, and provides a correspondingly slow rate of drug release.

Abstract: Bioactive, hydroforming luminal liner compositions are formed of high molecular weight crystalline, absorbable copolyesters dissolved in a liquid derivative of a polyether glycol that undergoes transformation into a tissue-adhering, resilient interior cover or liner for the controlled release of its bioactive payload at clinically compromised conduits in humans as in the case of bacteria- and yeast-infected vaginal canals, esophagi, and arteries following angioplasty.

Abstract: Delivery systems and compositions comprised of a biodegradable polyorthoester polymer, an aprotic solvent, and a drug are described. The solvent is selected to modulate release of drug from the composition, where, in some embodiments, the solvent is rapidly released after administration and provides a corresponding rapid rate of drug release. Alternatively, in other embodiments, the solvent is slowly released from the composition after its administration, and provides a correspondingly slow rate of drug release.

Abstract: The present invention provides implants comprising a therapeutic drug and a polymer containing polylactic acid (PLA) and optionally polyglycolic acid (PGA). The present invention also provides methods of maintaining a therapeutic level of a drug in a subject, releasing a therapeutic drug at a substantially linear rate, and treating schizophrenia and other diseases and disorders, utilizing implants of the present invention.

Abstract: The present invention aims to provide a method of producing a hydrophilic modified polyrotaxane, which enables production of a hydrophilic modified polyrotaxane excellent in storage stability in an industrially advantageous way. The present invention provides a method of producing a hydrophilic modified polyrotaxane, comprising: a hydrophilic modification step of preparing a solution of a hydrophilic modified polyrotaxane by modifying all or part of hydroxy groups on a cyclodextrin of a polyrotaxane with hydrophilic modifying groups, the polyrotaxane containing the cyclodextrin, a polyethylene glycol included in the cavities of the cyclodextrin molecules in a skewered manner, and a capping group that is placed at each end of the polyethylene glycol and prevents dissociation of the cyclodextrin molecules from the polyethylene glycol; and a drying step in which the prepared solution of the hydrophilic modified polyrotaxane is formed into a thin film state and dried.

Abstract: The present invention provides a bone connection material that includes an internal layer. The internal layer is formed by braiding a plurality of filaments. The internal layer that is formed by braiding filaments is resistant to lateral shearing forces and may provide flexibility so as to achieve wide applications. Further, the present invention overcomes the drawback of the conventionally used metallic materials that are rigid and inelastic and also overcomes the problem of polylactic acid material of being brittle. Thus, the bone formed according to the present invention is close to a natural bone and is more suitable for uses in portions where frequent movements are made and scaffolds of stem cells.

Abstract: A composition of matter and method for preparation of a tissue augmentation material. A polysaccharide gel composition is prepared with rheological properties selected for a particular selected application. The method includes preparing a polymeric polysaccharide in a buffer to create a polymer solution or gel suspending properties in the gel and selecting a rheology profile for the desired tissue region.

Abstract: The invention relates to a dental restorative material which comprises a thermolabile compound of Formula I: [(Z1)m-Q1-X)]k-T-[Y-Q2-(Z2)n]l??Formula I, in which T represents a thermolabile unit which contains at least one thermolabile group based on non-covalent interactions, Z1 and Z2 in each case independently represent a polymerizable group selected from vinyl groups, CH2?CR1—CO—O— and CH2?CR1—CO—NR2— or an adhesive group selected from —Si(OR)3, —COOH, —O—PO(OH)2, —PO(OH)2, —SO2OH and —SH, Q1 in each case independently is missing or represents an (m+1)-valent linear or branched aliphatic C1-C20 radical which can be interrupted by —O—, —S—, —CO—O—, —O—CO—, —CO—NR3—, —NR3—CO—, —O—CO—NR3—, —NR3—CO—O— or —NR3—CO—NR3—, Q2 in each case independently is missing or represents an (n+1)-valent linear or branched aliphatic C1-C20 radical which can be interrupted by —O—, —S—, —CO—O—, —O—CO—, —CO—NR3—, —NR3—CO—, —O—CO—NR3—, —NR3—CO—O— or —NR3—CO—NR3—, X and Y in each case independently are missing or represent —O—, —

Abstract: The present invention aims to provide a polyrotaxane composition having excellent storage stability. The present invention relates to a polyrotaxane composition comprising: a polyrotaxane containing a cyclodextrin, a polyethylene glycol which is included in the cavities of the cyclodextrin molecules in a skewered manner, and a capping group that is placed at each end of the polyethylene glycol and prevents dissociation of the cyclodextrin molecules from the polyethylene glycol; and a polyphenol antioxidant.

Abstract: A drug-delivering insertable medical device for treating a medical condition associated with a body lumen is disclosed. The drug-delivering insertable medical device includes an outer surface coated with two or more nano-carriers having two or more average diameters. A nano-carrier of the two or more nano-carriers has an average diameter suitable for penetrating one or more layers of two or more layers of the body lumen. The nano-carrier includes a drug surrounded by an encapsulating medium. The encapsulating medium includes one or more of a biological agent, a blood excipient, and a phospholipid.

Abstract: The present invention aims to provide a method of producing a powdered hydrophilic modified polyrotaxane, which enables production of a powdered hydrophilic modified polyrotaxane excellent in storage stability in an industrially advantageous way.

Abstract: Effective treatments of acute pain for extended periods of time are provided. The treatments include the administration of one or more drug depots at or near a target site wherein the drug depots include an effective amount of clonidine formulated within a polyorthoester. By administration of one or more drug depots at or near the target site, one can relieve pain caused by diverse sources, including but not limited to spinal disc herniation (i.e. sciatica), spondilothesis, stenosis, discongenic back pain and joint pain, as well as pain that is incidental to surgery. In some embodiments, the relief can be for at least twenty-five days, at least fifty days, at least one hundred days or at least one hundred and thirty-five days.

Abstract: Effective treatments of pain and inflammation are provided. Through the administration of an effective amount of fluocinolone at or near a target site, one can reduce, prevent or treat inflammation and pain and autoimmune disorders. In various embodiments, fluocinolone formulations may be provided within biodegradable polymers to reduce, prevent or treat sciatic pain and/or inflammation. In various embodiments, prevent transplant rejection for at least twenty-five days. In some embodiments, the pain relief can be for 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: Effective treatments of pain and/or inflammation from degenerative disc disease and/or facet joint are provided. Through the administration of an effective amount of at least one alpha adrenergic agonist at or near a degenerative disc and/or facet joint, one can reduce, prevent or treat pain and/or inflammation caused by the degenerative disc disease and/or facet joint.

Abstract: The present invention aims to provide a method for producing a refined polyrotaxane which includes an industrially advantageous method of producing a polyrotaxane that has excellent storage stability. The method for producing a refined polyrotaxane includes the step of heat-cleaning a polyrotaxane with a cleaning medium, the polyrotaxane containing cyclodextrin molecules, a polyethylene glycol which is included in the cavities of the cyclodextrin molecules in a skewered manner, and a capping group that is placed at each end of the polyethylene glycol and prevents dissociation of the cyclodextrin molecules from the polyethylene glycol.

Abstract: The present disclosure relates to a method of melt processing an active agent. The method may include encapsulating an active agent in a first polymer material exhibiting a first processing temperature T1 and forming capsules including the active agent. The method may also include melt processing the capsules with a second polymer material exhibiting a second processing temperature T2, wherein T1>T2.

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.