Abstract: Provided is a compression resistant implant configured to fit at or near a bone defect to promote bone growth. The compression resistant implant comprises a biodegradable polymer in an amount of about 0.1 wt % to about 20 wt % of the implant and a freeze-dried oxysterol in an amount of about 5 wt % to about 90 wt % of the implant. Methods of making and use are further provided.

Abstract: Apparatus for delivery of bone includes a syringe body and a plunger. The syringe body includes a tip at a bottom thereof, a funnel-shaped top at the top thereof, and a tubular section having a generally cylindrical interior wall defining a passageway extending from the funnel-shaped top to the tip. The plunger includes an elongate piston, a press head, and a handle. The piston extends between the press head at a lower end of the plunger, and the handle at an upper end of the plunger. The plunger is removably received within the passageway, with an extent of the plunger extending out of the funnel-shaped top away from the syringe body. The syringe body may be loaded with one or more bone pellets or cartridges containing bone.

Abstract: A method for providing a sterile pharmaceutical composition in a pre-filled syringe, the method including solubilizing an active agent and a pH adjusting agent in a solvent to provide a pharmaceutical composition, filtering the pharmaceutical composition through a membrane to provide a sterile pharmaceutical composition, and providing the sterile pharmaceutical composition in a pre-filled syringe having a labeled size, wherein the active agent includes sugammadex, the pre-filled syringe has a headspace volume that is less than 7.5% of the labeled size, and the method is free of a heat-based sterilization process. Also provided are sterile pharmaceutical compositions prepared according to the method.

Abstract: Provided is an implant configured to fit at or near a bone defect to promote bone growth, the implant comprising: a biodegradable polymer in an amount of about 0.1 wt % to about 20 wt % of the implant and an oxysterol in an amount of about 20 wt % to about 90 wt % of the implant. The implant has a high oxysterol load. Methods of making and use are further provided.

Abstract: The present invention provides a novel way to replenish the disc using retooled disc compositions to repair degenerative discs. There is no better source of proteoglycans than the actual disc material (6) itself. To this end, there has been developed a technique to remove the nucleus pulposus and retool the morphology of the nucleus pulposus to create a powder material (10) that is dry and can be stored at room temperature for long periods of time. This powder (10) can then be reconstituted with a variety of fluids, the most suitable being normal saline or lactated ringers to form a flowable mixture (20).

Abstract: The present invention provides a novel way to replenish the disc using retooled disc compositions to repair degenerative discs. There is no better source of proteoglycans than the actual disc material (6) itself. To this end, there has been developed a technique to remove the nucleus pulposus and retool the morphology of the nucleus pulposus to create a powder material (10) that is dry and can be stored at room temperature for long periods of time. This powder (10) can then be reconstituted with a variety of fluids, the most suitable being normal saline or lactated ringers to form a flowable mixture (20).

Abstract: A porous three-dimensional structure of polytetrafluoroethylene was created featuring an enhanced ability of soft tissue ingrowth, or, in the second embodiment, combining the properties of an enhanced ability of soft tissue ingrowth with a barrier for the deposition of the living tissue cells. In the first embodiment of the porous three-dimensional structure of polytetrafluoroethylene it contains the open through pores and the blind pores, uniformly distributed over the inner surfaces of the open pores and connected therewith, and is made of mixture of the free-flow polytetrafluoroethylene having the granules sized from 100 to 300 microns, and the constraint-flow polytetrafluoroethylene having the granules sized up to 20 microns. In the second embodiment of the porous three-dimensional structure at least one surface of the three-dimensional body is provided with a barrier layer.

Abstract: Provided are therapeutic implants comprising renal tissue encapsulated within a polymer bead. Also disclosed are methods for treating a disease state in a subject comprising implanting within said subject a therapeutic implant comprising renal tissue encapsulated within a polymer bead. Also provided are methods for making a therapeutic implant comprising: providing renal tissue; mixing the renal tissue with a solution comprising a polymer, thereby forming a tissue-polymer suspension; extruding the tissue-polymer suspension into an bead-forming solution, thereby forming a therapeutic implant comprising beads of said polymer within which the renal tissue is encapsulated.

Abstract: Provided are methods of delivering at least one pharmaceutical agent to the central nervous system (CNS) of a subject, methods of treating a neurological disorder or pain in a subject that include administering at least one pharmaceutical agent onto a SEM graft in the skull base of the subject. Also provided are methods of treating a neurological disorder or pain in a subject that include forming a SEM graft in the skull base of the subject and administering at least one pharmaceutical agent onto the SEM graft in the skull base of the subject. Also provided are methods of forming a SEM graft in the skull base of a subject, compositions for administration onto a SEM graft in the skull base or into an endonasal reservoir or endonasal reservoir device in a subject, and devices for administering such compositions onto a SEM graft in the skull base of a subject.

Abstract: A collagenous biomaterial medical device comprising a molded sponge material formed from comminuted submucosa fragments that have not been cross-linked with a cross-linking agent, wherein said submucosa has at least one biotropic agent, and wherein said biotropic agent is a growth factor is disclosed.

Abstract: Methods can prepare tissue engineering scaffolds that include a plurality of biocompatible core/shell microspheres linked together to form a three-dimensional matrix. The matrix can include a plurality of pores for growing cells. The biocompatible microspheres can include first and second sets of microspheres. The first set of microspheres can have a first characteristic, and a first predetermined spatial distribution with respect to the three-dimensional matrix. The second set of microspheres can have a second characteristic that is different from the first characteristic, and a second predetermined spatial distribution that is different from the first predetermined spatial distribution with respect to the three-dimensional matrix.

Abstract: Provided are therapeutic implants comprising renal tissue encapsulated within a polymer bead. Also disclosed are methods for treating a disease state in a subject comprising implanting within said subject a therapeutic implant comprising renal tissue encapsulated within a polymer bead. Also provided are methods for making a therapeutic implant comprising: providing renal tissue; mixing the renal tissue with a solution comprising a polymer, thereby forming a tissue-polymer suspension; extruding the tissue-polymer suspension into an bead-forming solution, thereby forming a therapeutic implant comprising beads of said polymer within which the renal tissue is encapsulated.

Abstract: Implants having improved mechanical properties and/or degradation profiles, kits including such implants, and methods of producing and using the same.

Abstract: Provided are methods of delivering at least one pharmaceutical agent to the central nervous system (CNS) of a subject, methods of treating a neurological disorder or pain in a subject that include administering at least one pharmaceutical agent onto a SEM graft in the skull base of the subject. Also provided are methods of treating a neurological disorder or pain in a subject that include forming a SEM graft in the skull base of the subject and administering at least one pharmaceutical agent onto the SEM graft in the skull base of the subject. Also provided are methods of forming a SEM graft in the skull base of a subject, compositions for administration onto a SEM graft in the skull base or into an endonasal reservoir or endonasal reservoir device in a subject, and devices for administering such compositions onto a SEM graft in the skull base of a subject.

Abstract: Described herein are tissue grafts composed of at least one membrane, where at least one side of the membrane has micronized placental tissue applied it. Also described herein are methods for making and using the tissue grafts.

Abstract: The invention is directed to an ion plasma deposition (IPD) method adapted to coat polymer surfaces with highly adherent antimicrobial films. A controlled ion plasma deposition (IPD) process is used to coat a metal or polymer with a selected metal/metal oxide. Exposing the coated surface to ultraviolet light significantly improves the antimicrobial properties of the deposited coatings.

Abstract: The present invention provides biocompatible composite materials that can be fabricated into a scaffold having properties suitable for bone repair and regeneration. These scaffolds have sufficient mechanical strength to be useful for the repair and regeneration of cortical bone.

Abstract: Techniques, mixtures, mixing and delivery kits, and improved delivery instruments for implantation of micronized allograft tissue over a microfractured defect. Allograft cartilage tissue is delivered over a cartilage defect that has been debrided and microfractured, without the need for a periosteal covering or separate type of patch sewn over the top. The allograft tissue may be any micronized cartilage particulates obtained by various methods, for example, cartilage delivered in its native form, dehydrated via lyophilization, “freeze-dried,” dehydrated via desiccation, or dehydrated by any other method.

Abstract: The present invention concerns a biomaterial comprising a nanofibrous scaffold made of polymers, such as poly(?-caprolactone) or collagen, coated with at least one layer pair consisting of a layer of polyanions and a layer of polycations, wherein said at least one layer pair incorporates a therapeutic molecule such as a growth factor. The biomaterial may optionally comprise living cells such as osteoblasts and/or chondrocytes.

Abstract: The present invention is directed to implantable bioabsorbable non-woven self-cohered web materials having a high degree of porosity. The web materials are very supple and soft, while exhibiting proportionally increased mechanical strength in one or more directions. The web materials often possess a high degree of loft. The web materials can be formed into a variety of shapes and forms suitable for use as implantable medical devices or components thereof.

Abstract: The present invention relates to a novel bone graft and methods for producing said graft. Said bone graft can be used for surgical, plastic and/or cosmetic bone replacement for a patient in need thereof. The bone graft is made of a scaffold or matrix of sheet material having a 3-dimensional pattern of a continuous network of voids and/or indentations for enhancing new bone growth.

Abstract: A patient's obstructive sleep apnea is treated by placing a fibrosis-inducing agent is placed within the tongue in a region extending substantially from a hyoid bone rearward toward a back surface of the tongue and upwardly along the back wall toward a free end of a soft palate of the patient.

Abstract: An assembly for fixating a prosthesis in body tissue such as bone of a mammal, comprising a mechanical compacting device and a mass comprising at least granules of a biocompatible material having a sponge-like structure, wherein the mechanical compacting device is designed for compacting the granules during use by insertion of the device in a hole in bone and subsequently inducing relative movement of at least a first part of the compacting device relative to a second part thereof, such that the volume of at least one space between at least part of an outer surface of the device and the adjacent inner surface of said hole is reduced.

Abstract: A method for treating a vertebral bone comprises providing a plurality of hollow microparticles and providing a flowable and settable bone filling material. The method further comprises mixing the plurality of hollow microparticles with the bone filling material to form a bone augmentation material. The method further comprises inserting an injection device into the vertebral bone and injecting the bone augmentation material from the injection device and into the vertebral bone.

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

Abstract: A system and method for treating bone abnormalities including vertebral compression fractures and the like. In one method, an elastomeric composite implant body is inserted into bone. A rigid insert can be inserted into the elastomeric composite implant body. The elastomeric composite implant body can be deformed with the rigid insert to thereby form an interference fit between the bone and the implant.

Abstract: A method of treating a ligament or tendon according to the present invention can include inserting a tissue-generating implant into the ligament or tendon to thereby treat the defect. The tissue-generating implant has a plurality of microparticles. The microparticles subsequently form a biological scaffold which operates at least as partial connective tissue in the ligament or tendon giving structural support during regrowth.

Abstract: Implants, such as interbody spacers, fusion devices and bone grafts, are provided having improved mechanical properties and/or degradation profiles. Such implants include a three-dimensional scaffold formed from particles, such as microspheres, which may in some embodiments be resorbable or biodegradable and which may have at least two different degradation rates. In some embodiments, the scaffold may be elastomeric. The three-dimensional scaffold may be for example, porous or semi-porous. Also provided are kits including such implants, and methods of producing and using the same.

Abstract: The present invention is directed to implantable bioabsorbable non-woven self-cohered web materials having a high degree of porosity. The web materials are very supple and soft, while exhibiting proportionally increased mechanical strength in one or more directions. The web materials often possess a high degree of loft. The web materials can be formed into a variety of shapes and forms suitable for use as implantable medical devices or components thereof.

Abstract: A tissue graft composition is described herein that includes a segment of small intestinal submucosa having at least one nanoparticle incorporated therein such that the permeability of the segment of small intestinal submucosa is altered, thereby providing the segment of small intestinal submucosa with a more substantially uniform structure for cell migration and proliferation. The tissue graft composition may further comprise at least one macromolecule incorporated into the nanoparticle. The tissue graft composition may be utilized in seeded or unseeded methods of tissue repair.

Abstract: The present invention is directed to implantable bioabsorbable non-woven self-cohered web materials having a high degree of porosity. The web materials are very supple and soft, while exhibiting proportionally increased mechanical strength in one or more directions. The web materials often possess a high degree of loft. The web materials can be formed into a variety of shapes and forms suitable for use as implantable medical devices or components thereof.

Abstract: The present invention is directed to implantable bioabsorbable non-woven self-cohered web materials having a high degree of porosity. The web materials are very supple and soft, while exhibiting proportionally increased mechanical strength in one or more directions. The web materials often possess a high degree of loft. The web materials can be formed into a variety of shapes and forms suitable for use as implantable medical devices or components thereof.

Abstract: Implants, such as interbody spacers, fusion devices and bone grafts, are provided having improved mechanical properties and/or degradation profiles. Such implants include a three-dimensional scaffold formed from particles, such as microspheres, which may in some embodiments be resorbable or biodegradable and which may have at least two different degradation rates. In some embodiments, the scaffold may be elastomeric. The three-dimensional scaffold may be for example, porous or semi-porous. Also provided are kits including such implants, and methods of producing and using the same.

Abstract: The subject invention provides materials and methods for soft tissue augmentation. The materials and methods of the subject invention can, advantageously, be used to correct defects such as velopharyngeal insufficiency after cleft palate repair. Other uses include treatments for gastroesophageal acid-reflux, urinary incontinence, wrinkles and contour abnormalities.

Abstract: Nanomaterials for neural and orthopedic prostheses are disclosed. Composite carbon nanofibers enhance neuronal growth and minimize glial scar tissue formation. Methods and compositions to promote neuronal growth and minimize scar tissue formation during prolonged monitoring and treatment of neural tissue are disclosed. Composite polyurethane carbon nanofiber is a suitable material for neural implant. Composite carbon nanomaterials decrease adhesion of astrocytes and fibroblasts.

Abstract: An improved, polymeric surgical membrane, which can be used in a variety of surgical procedures, such as sutured and sutureless duraplasty procedures. For sutureless applications, a textured, discontinuous, outer polymer layer is provided which encourages rapid incorporation and anchoring into surrounding tissue. In cooperation with the discontinuous first layer, a second elastomeric layer provides elasticity and resilience. A third barrier layer is provided to essentially eliminate adhesions and irritation to surrounding tissue. In those applications requiring anchoring sutures, the second elastomeric layer “self-seals” against the sutures, essentially eliminating the leakage of blood, cerebrospinal fluid, or other fluids. In addition, the composite structure of the present invention has a high degree of suture retention strength is polymeric with a high degree of biocompatibility, is thin and very flexible.

Abstract: Embolic compositions and methods of delivering the compositions are disclosed. In some embodiments, the embolic compositions include a shape memory material.

Abstract: The invention relates to a remarkably simple method for the in vitro production of three-dimensional, vital and mechanically stable cartilage or bone tissue and to the use thereof as a transplantation material for treating cartilage or bone defects and degenerative diseases such as rheumatism or arthrosis, and to the use thereof in testing active substances and physical factors. The invention is also directed to the cartilage or bone tissue and therapeutical formulations produced thereby, e.g. injection solutions comprising such tissue.

Abstract: This invention is directed to the field of medical implants, and more specifically to biodegradable injectable implants and their methods of manufacture and use. The injectable implants disclosed herein comprise glycolic acid and bio-compatible/bio-absorbable polymeric particles containing a polymer of lactic acid. The particles are small enough to be injected through a needle but large enough to avoid engulfment by macrophages. The injectables of this invention may be in a pre-activated solid form or an activated form (e.g., injectable suspension or emulsion).

Abstract: A mammalian tissue scaffold and method for making a tissue scaffold including a rigid scaffold body of biocompatible glass fibers bonded together and in special alignment to define open channels within the scaffold to allow fluid flow into and within the scaffold.

Abstract: In-vivo biodegradable medical implants, containing at least in part at least partially fine-grained metallic materials that are strong, tough, stiff and lightweight, are disclosed The in-vivo biodegradable implants are used in a number of stent applications, for fracture fixation, sutures and the like.

Abstract: The subject invention provides materials and methods for soft tissue augmentation. The materials and methods of the subject invention can, advantageously, be used to correct defects such as velopharyngeal insufficiency after cleft palate repair. Other uses include treatments for gastroesophageal acid-reflux, urinary incontinence, wrinkles and contains abnormalities.

Abstract: An improved, polymeric surgical membrane, which can be used in a variety of surgical procedures, such as sutured and sutureless duraplasty procedures. For sutureless applications, a textured, discontinuous, outer polymer layer is provided which encourages rapid incorporation and anchoring into surrounding tissue. In cooperation with the discontinuous first layer, a second elastomeric layer provides elasticity and resilience. A third barrier layer is provided to essentially eliminate adhesions and irritation to surrounding tissue. In those applications requiring anchoring sutures, the second elastomeric layer “self-seals” against the sutures, essentially eliminating the leakage of blood, cerebrospinal fluid, or other fluids. In addition, the composite structure of the present invention has a high degree of suture retention strength is polymeric with a high degree of biocompatibility, is thin and very flexible.

Abstract: Constructs that are at least partially constructed of allograft cancellous bone are disclosed, along with cartilage particles that may be used with the constructs for repairing articular cartilage defects. A multi-piece construct includes a base member, a cap member and at least one pin that secures the cap member to the base member. The base member may be constructed of mineralized cancellous bone, and is used to replace the subchondral bone removed when a surgeon cuts a bore in the area of an adjacent cartilage defect. The base member includes a blind bore and first and second through-going transverse bores in opposite sides of a wall of the base member. The cap member includes an upper section that has a thickness that is similar to that of a patient's surrounding articular cartilage layer and a stem depending from the upper section that is dimensioned to be received in and by the blind bore of the base member.

Abstract: Embolic compositions and methods of delivering the compositions are disclosed. In some embodiments, an embolic composition includes a first collection of particles having a first shape, and a second collection of particles having a second shape different than the first shape.

Abstract: A medical device and system capable of providing on-demand delivery of biologically active material to a body lumen patient, and a method of making such medical device. A first coating layer comprising a biologically active material and optionally a polymeric material is disposed on the surface of the medical device. A second coating layer comprising magnetic particles and a polymeric material is disposed on the first coating layer. The second coating layer, which is substantially free of a biologically active material, protects the biologically active material prior to delivery. The system includes the medical device and a source of energy, such as an electromagnetic or mechanical vibrational energy. When the patient is exposed to the energy source, the magnetic particles move out of the second coating layer and create channels therein through which the biologically active material can be released.

Abstract: An implantable member for use in the body is provided herein. This implantable member includes a porous biocompatible substrate; the substrate having at least one surface sealed fluid-tight with self-aggregating protein particles of substantially the same diameter range. The self-aggregated protein particles are formed from a deposited aqueous slurry of the protein particles.

Abstract: The invention provides a method and a kit for administering bone cement to the interior cavity of a bony member to enhance bone strength, stabilizing an existing fracture thus reducing susceptibility of the bone to further fracture and/or collapse. The method and kit may include additional components, such as, bone growth enhancing agents, radiopaque components or the like.

Abstract: The present invention provides a method of modifying the lower esophagus by injecting biocompatible particles in a biocompatible carrier into a submucosal tissue site of the lower esophagus of a patient. The method may be used to treat gastroesophageal reflux disease by optimizing the closing function of the lower esophageal sphincter.

Abstract: The present invention is directed toward recellularizing a devitalized cartilage graft with viable recellularizable cells in vivo, in situ, or in vitro to render the tissue vital. The present invention is also directed toward repairing a cartilage defect and implanting a cartilage graft into a human or animal by crafting a cartilage matrix into individual grafts, disinfecting and cleaning the cartilage graft, applying a pretreatment solution to the cartilage graft, removing cellular debris using an extracting solution to produce a devitalized cartilage graft, recellularizing the devitalized cartilage graft, implanting the cartilage graft into the cartilage defect with or without an insertion device, and sealing the implanted cartilage graft with recipient tissue. The devitalized cartilage graft is optionally stored between the removing cellular debris and the recellularizing steps.