Abstract: Described are implants for placing in a body, tools for delivering the implants, and systems and methods for using implants and tools for placing in a body and more particularly to nasal implants, tools for delivering nasal implants, and systems and methods for using such implants and tools. A tool may include a hand-held implant delivery device that holds, moves, orients, inserts, or shapes an implant. An implant may be a biodegradable, longitudinal implant that may be oriented for implantation by an implant delivery device.

Abstract: The disclosure provides a method for cleaning an implanted medical device. In one embodiment, the method includes providing a medical device including a membrane; wherein the membrane comprises a thermoresponsive hydrogel including N-isopropylacrylamide (NIPAAm) or poly(N-isopropylacrylamide) (PNIPAAm), and a volume phase transition temperature (VPTT). The method also includes implanting the medical device into a target area; wherein the membrane temperature is maintained at substantially the same temperature as the target area; wherein temperature fluctuations within the target area that approach, meet and/or exceed the volume phase transition temperature induce deswelling or relative deswelling in the membrane and temperature fluctuations within the target area that are relatively lower and/or approach and/or fall below the volume phase transition temperature induce swelling or relative swelling in the membrane.

Abstract: Bone-contacting surfaces and free surfaces of orthopedic implants. The implants are additively manufactured, followed by mechanical, chemical, or mechanical and chemical erosion. At least some of the surfaces of the implants include an osteoinducting roughness that has micro-scale structures and nano-scale structures that facilitate and enhance osteoinduction and osteogenesis, as well as enhanced alkaline phosphatase, osterix, and osteocalcin expression levels along the pathway of mesenchymal stem cell differentiation to osteoblasts.

Abstract: The present disclosure in one aspect provides a surgical implant comprising an upper bone contacting surface comprising a plurality of irregularly shaped pores having an average pore size, where the pores are formed by a plurality of struts, a lower bone contacting surface comprising a plurality of irregularly shaped pores having an average pore size, wherein the pores are formed by a plurality of struts; and a central body comprising a plurality of irregularly shaped pores having an average pore size, wherein the pores are formed by a plurality of struts, wherein the average pore size on the upper and lower bone contacting surfaces is different than the average pore size on the central body.

Abstract: A scaffold includes struts that intersect at nodes. In some instances, a cross section of the cores has at least one dimension less than 100 microns. The core can be a solid, liquid or a gas. In some instances, one or more shell layers are positioned on the core.

Abstract: Disclosed is a medical device having a substrate having an exposed surface and a texture over at least part of the exposed surface. The texture includes a plurality of nanofeatures that inhibit bacterial adhesion on the surface and that also inhibit bacterial growth on the surface and have a size range between about 0.01 nanometers and about 1,000 nanometers. The texture can include a plurality of nanofeatures applied thereto such that the texture has a first particle size at a first location, a second particle size at a second location, and a gradient of particle size from the first particle size to the second particle size between the first location and the second location.

Abstract: The invention relates to polyelectrolyte multilayer coatings and, methods for their preparation and application to substrates to enhance the bioactivity and corrosion protection of the substrates' surface. The invention is particularly suitable for coating substrates employed for medical applications, such as but not limited to medical implant devices for drug and/or biologics delivery in a patient. The substrate has a positive or negative charge. The polyelectrolyte multilayer coatings include at least a first polymer layer and a second polymer layer. The first polymer and second polymer have opposite charges. Each of the polymer layers is individually applied using a layer-by-layer such that an alternating charge multilayer coating is formed.

Abstract: Embodiments of an implant that is configured with materials to prevent degradation or corrosion. The implant can comprise an elongate body and a degradation-delaying element disposed thereon, where the degradation-delaying element can be configured to reduce or retard corrosion of the elongate body.

Abstract: Systems, devices, and methods are provided for orthopedic implants. The implants may include a base member, such as an acetabular shell or an augment, that is configured to couple with an augment, flange cup, mounting member, or any other suitable orthopedic attachment. Any of the implantable components may be include one or more porous surfaces. The porous surface may be textured by protrusions that connect to and extend from the surface. The sizes and concentration of the protrusions may be varied for specific applications to accommodate different implants and patient anatomies. A porous implant may also include one or more internal or external solid portions that strengthen the implant.

Abstract: A coating for a roughened metal surface of an implantable medical device includes a poly(ethylene glycol) disposed on at least a portion of the roughened metal surface, wherein the poly(ethylene glycol) is covalently bonded directly to the roughened metal surface.

Abstract: A biocompatible and biodegradable polymeric step-index optical fiber includes a core and a cladding around the core. The core is made from a core material fabricated by bonding a citric acid and at least a first monomer using a synthesis process. The cladding is made from a cladding material fabricated by bonding the citric acid and at least a second monomer using the synthesis process. The core has a refractive index higher than that of the cladding, while a difference between an initial modulus of the core and the cladding is preferably less than 30% and a difference between the biodegradation rates of the core and cladding is preferably less than 30% after about 4 weeks. Optical properties of the core and cladding are tunable by adjusting monomer ratios, choices of monomers or cross-linking degrees.

Abstract: The present invention is based on that local administration of strontium ions in bone tissue has been found to improve the bone formation and bone mass upon implantation of a bone tissue implant in said bone tissue. In particular, the invention relates to a bone tissue implant having an implant surface covered by an oxide layer comprising strontium ions and a method for the manufacture thereof. A blasting powder comprising strontium ions, a method for locally increasing bone formation, and the use of strontium ions or a salt thereof for manufacturing a pharmaceutical composition for locally increasing bone formation are also provided by the present invention.

Abstract: A monolithic titanium alloy having, in a temperature range (?T) and at atmospheric pressure: an outer peripheral zone of a microstructure having a modulus of elasticity (E1) and possessing superelastic properties in the range (?T), and a core of a microstructure having a modulus of elasticity (E2), and possessing elastic properties in the range (?T); the microstructures and being different from one another, and the modulus of elasticity (E1) being lower than said modulus of elasticity (E2).

Abstract: To obtain improved bio-affinity and high bone attachment in an implant body, a method of manufacture for the implant body, and a dental implant. The implant body is fixed in a contact configuration to bone, and includes the base material formed from zirconia, and a surface layer formed on the surface of the base material and having a lower hardness than the base material. Therefore, in addition to having superior mechanical strength due to the zirconia base material, the soft and flexible surface layer functions as a buffer layer to mitigate the difference in the degree of hardness between the bone and the base material, and therefore the soft surface further improves the bone adhesion characteristics.

Abstract: Mechanical devices such as prosthetic knees, hips, shoulders, fingers, elbows, wrists, ankles, fingers and spinal elements when implanted in the body and used as articulating elements are subjected to wear and corrosion. These prosthetic implants are usually fabricated in modular form from combinations of metallic materials such as stainless steels, Co—Cr—Mo alloys, and Ti—Al—V alloys; plastics such as ultra high molecular weight polyethylene (UHMWPE); and ceramics such as alumina and zirconia. As the articulating surfaces of these materials wear and corrode, products including plastic wear debris, metallic wear particles, and metallic ions will be released into the body, transported to and absorbed by bone, blood, the lymphatic tissue, and other organ systems. The polyethylene wear particles have been shown to produce long term bone loss and loosening of the implant.

Abstract: Described herein is the synthesis of adhesive from simple adhesive coacervates and their uses thereof. The adhesives are produced by (a) preparing a solution comprising (1) a polyelectrolyte, wherein the polyelectrolyte comprises a polyanion or polycation but not a combination thereof, the polyeletrolyte comprises at least one crosslinking group, and (2) a sufficient amount of a complimentary counterion to produce a simple adhesive coacervate; and (b) crosslinking the simple adhesive coacervate to produce the adhesive. The adhesives have numerous medical and non-medical applications.

Abstract: Systems and methods for providing tissue-interfacing surface layers with increased roughness can be attained by providing a metallic powder to a machined or previously machined tissue-interfacing surface of a porous foam structure. The metallic powder can have sizes and characteristics such that the porous structure can have an increased roughness at the tissue-interfacing machined surface while inhibiting the occlusion of the open pores in the porous metallic foam structure.

Abstract: The present invention involves tissue engineering constructs made from a new composite bone graft material made from biocompatible poly(D,L-lactic-co-glycolic acid) (PLGA) and bioceramic particles exposed on its surface using a gas foaming particle leaching (GF/PL) method and infused with collagen. Methods and apparatus for of forming scaffolds are also disclosed.

Abstract: A porous structure and a porous assembly resulted therefrom for implants allow a tissue to go through and attach for ingrowth, thereby achieving an ideal fixing effect. At least one porous structure is provided with a plurality of geometric-contoured apertures defined by walls. At least one channel is disposed on the apertures or the walls along a reference axis so that the adjoining apertures are intercommunicated, and the porous structures are connected and/or stacked with each other to contribute a porous assembly.

Abstract: Methods and apparatus of providing a joint replacement parts with a pharmaceutical delivery system is provided. The pharmaceutical delivery system is placed within the joint replacement parts to provide, over a period of time, sustained release of a controlled concentration of pharmaceuticals within the joint space of the joint replacement and to produce a local or systemic physiological of pharmacological effect.

Abstract: A bioabsorbable plug implant, suitable for bone tissue regeneration, comprising a first portion, and a second portion extending outwardly from the first portion, the first and second portions formed from expandable material. A method for bone tissue regeneration comprising the steps of: providing a bioabsorbable plug implant, wherein the implant comprises a first portion and a second portion extending outwardly from the first portion, the first and second portions formed from expandable material; inserting the second portion into a defect or gap of a bone, the first surface engaging the outside contour of the defect or gap; allowing the plug implant to contact body fluids, thereby expanding the size of the plug implant so that the plug fits into the defect or gap.

Abstract: The present invention relates to a process for modifying the surface morphology of a medical device. The modified surface has, among other advantageous properties, an improved capacity for sorption or conjugation of a variety of bioactive agents, the addition of which will turn the medical device into a localized drug delivery system.

Abstract: The present invention comprises devices, systems, and methods for elongating bone using an extension implant having a first end and a second end. The first end of the extension implant is inserted into an opening in the live bone and the second end of the extension implant is combined with an enlarged implant. A plurality of channels extend through the components to serve as conduits for delivering fluids and physiological signals which induce bone formation. Some embodiments include a subcutaneous cage assembly for helping to support the implant as the bone heals around it.

Abstract: An implant comprises a substrate and a coating on a surface of the substrate, and the coating comprises silicon nitride and has a thickness of from about 1 to about 15 micrometer. A method of providing the implant comprises coating a surface of the implant substrate with the coating comprising silicon nitride and having a thickness of from about 1 to about 15 micrometer by physical vapour deposition.

Abstract: Methods are presented for a continuous, two-step, phase sequenced deposition of hydroxyapatite film over the surface of the substrate.

Abstract: Disclosed herein is a method of using a medical implant in a subject. The method comprises treating a medical implant with ultraviolet light (UV) in a closed environment, causing the temperature of the medical implant to be between room temperature (Rt) and about 37° C., and immediately, and placing the implant of a temperature from about the room temperature to about 37° C. in a site in need within the subject.

Abstract: Devices and methods for treating or repairing a tissue or organ defect or injury are provided. The devices can include tissue scaffolds produced from acellular tissue matrices and polymers, which have a stable three-dimensional shape and elicit a limited immunologic or inflammatory response.

Abstract: The present invention provides a ceramic porous body for in-vitro and in-vivo use comprising a composition comprising a calcium aluminate (CA) containing phase and optionally at least one of an accelerator, a retarder, a surfactant, a foaming agent, a reactive alumina, water, a fiber, and a biologically active material, and combinations thereof. Ceramic compositions are provides as well as method of using the ceramic compositions and methods of manufacturing a ceramic porous body. The ceramic porous bodies of this invention may be used as artificial bones, joints, in-vitro support structures, and in-vivo support structures for cells, tissues, organs, and nerve growth and regeneration.

Abstract: Provided herein re a composition and a coating or a device (e.g., absorbable stent) that includes a PEGylated hyaluronic acid and a PEGylated non-hyaluronic acid biocompatible polymer and the methods of use thereof.

Abstract: A method for controlling generation of biologically desirable voids in a composition placed in proximity to bone or other tissue in a patient by selecting at least one water-soluble inorganic material having a desired particle size and solubility, and mixing the water-soluble inorganic material with at least one poorly-water-soluble or biodegradable matrix material. The matrix material, after it is mixed with the water-soluble inorganic material, is placed into the patient in proximity to tissue so that the water-soluble inorganic material dissolves at a predetermined rate to generate biologically desirable voids in the matrix material into which bone or other tissue can then grow.

Abstract: To improve a cartilage replacement implant for the biological regeneration of a damaged cartilage area of articular cartilage in the human body, comprising a cell carrier which has a defect-contacting surface for placement on the damaged cartilage area and is formed and designed for colonization with human cells, so that after implantation of the cartilage replacement implant, formation of a gap between adjacent contact surfaces of the implant and surrounding recipient tissue is minimized, it is proposed that the cell carrier rest with surface-to-surface contact on a carrier and be joined to the carrier at a cell carrier surface that faces away from the defect-contacting surface. A method for producing a cartilage replacement implant is also proposed.

Abstract: A transcutaneous prosthesis includes a first component shaped for implantation into a bone, the first component including flutes or grooves on a surface thereof for deterring rotation of the prosthesis within a bone; a second component adapted for location between the bone and the skin, the second component having a surface treatment for stimulation of fibroblastic cell proliferation and attachment of epithelial cells; and a third component adapted for location to extend from the skin surface and is adapted to extend directly from the skin surface in use, the third component having a coating of a non-stick material on an outer surface thereof, the coating having a surface energy that is lower than a surface energy of the first and second components and which is low enough to deter bacterial adhesion.

Abstract: Disclosed are a gradient bioceramic coating comprising a rare earth oxide, a broadband laser method for preparing the bioceramic coating, and the use of the bioceramic coating in the field of medical materials.

Abstract: Bone implant compositions and methods are provide that have an outer surface, the outer surface comprising demineralized bone and having a cavity disposed in the outer surface, the cavity having a demineralized bone material coated therein; and an inner surface of the bone implant comprising cortical bone, the inner surface contacting the outer surface. The bone implant compositions and methods provided are osteoinductive and allow rapid bone fusion.

Abstract: A method of preparing a preformed bone shape for implantation provides irradiating at least a portion of a preformed bone shape by a Neutral Beam derived from a GCIB, and the preformed bone shape so irradiated.

Abstract: The invention provides biomatrix compositions comprising cross-linked lactoferrin, either alone or in combination with other organic or inorganic components. Also provided are methods of making and using the biomatrix compositions. As described herein, cross-linked lactoferrin biomatrix retains the bioactivities of the lactoferrin molecule. The biomatrix composition can act as a matrix for cell adhesion and growth and is particularly useful in musculoskeletal tissue regeneration. The biomatrix compositions can be pre-formed or injectable and can act as a cell, drug or protein delivery vehicle.

Abstract: The invention relates to an implant with a coating (23) which releases silver ions in the human body and as a result has antimicrobial action. According to the invention, a first surface component of the coating (23) is formed by an anode material (25). A second surface component of the coating (23) is formed by a cathode material (26). The cathode material is higher in the electrochemical voltage series than the anode material (25). The cathode material (26) and the anode material (25) are connected to one another in an electrically conductive manner. Together with the body electrolyte in the environment of the implant, the anode material (25) and the cathode material (26) form a multitude of local galvanic elements. The antimicrobial action of the coating (23) is improved as a result.

Abstract: A method of modifying the surface of a medical device to release a drug in a controlled way by providing a barrier layer on the surface of one or more drug coatings. The barrier layer consists of modified drug material converted to a barrier layer by irradiation by an accelerated neutral beam derived from an accelerated gas cluster ion beam. Also medical devices formed thereby.

Abstract: A transdermal intraosseous device includes a transdermal adapter for an external prosthetic device for a bone of a patient and a bone fixator including a distal portion coupled to the transdermal adapter and a proximal portion for anchoring into the bone. The transdermal adapter includes a dome-shaped portion for transcutaneous implantation and an external shaft extending from the dome-shaped portion. A dermal transition structure is configured to include a controlled roughness gradient from the external shaft to the dome-shaped portion and configured for use in infection control at a dermis layer of the patient.

Abstract: One aspect of the present invention relates to a multilayer surgical membrane. The surgical membrane can include a substantially fluid impermeable outer layer, an inner layer that includes a plurality of fenestrae, and a middle region disposed between the inner and outer layers. The middle region can include at least one channel that extends through the middle region. The middle region can have a first surface in contact with the inner layer. The at least one channel can imbibe fluid under a compressive or tensile load and the fenestrae can deform to exude fluid under the load.

Abstract: Implantable devices having antibacterial activity for preventing periprosthetic infections and for improving osteointegration capacity are provided. Methods for making and using such devices are also provided.

Abstract: Biomedical implants (e.g., orthopedic implants) with modified surfaces that can enhance a cement bond's strength (e.g., tensile, shear, and/or fatigue) are disclosed, along with methods of manufacturing and using such implants. The implants can exhibit a variety of physical, chemical, or process-derived features which can enhance cement bonding. For instance, the implant surface can exhibit particular roughness values, and/or be substantially free of non native material. Processes for producing such implants can include providing a first roughened implant surface, which can be produced, for example, by particle blasting. A treatment formulation can be applied to the first roughened surface to create a second roughened surface that exhibits enhanced cement bonding properties relative to the first roughened surface. In some instances, the first roughened surface and the second roughened surface can exhibit substantially similar Ra values. The second roughened surface can exhibit a negative Rsk value.

Abstract: The invention provides reagents and method for replacing teeth lost to periodontitis and other diseases and disorders resulting in tooth loss, and provides materials and methods that result in replacement or reimplanted teeth that have a higher rate of stable, long-term implantation status. In a first aspect, the invention provides an implantable tooth, comprising a natural or artificial animal tooth having a microporous tooth root surface, wherein said tooth root surface comprises a plurality of periodontal ligament progenitor cells coating all or a portion of the tooth root. In particular embodiments, the tooth is a natural tooth, especially a human tooth. In alternative embodiments, the tooth is an artificial tooth. In particular embodiments, the tooth comprises a periodontal ligament progenitor cell coating that further comprises one or a plurality of extracellular matrix proteins. In a second aspect, the ivnention provides kits for preparing an implantable tooth.

Abstract: The disclosed methods, uses and articles are in the field of orthopedic and dental implants. In particular, the disclosure relates to compositions and methods for improving the osseointegration of such implants.

Abstract: A composition of matter comprising a water-swellable IPN or semi-IPN including a hydrophobic thermoset or thermoplastic polymer and an ionic polymer, articles made from such composition and methods of using such articles. The invention also includes a process for producing a water-swellable IPN or semi-IPN from a hydrophobic thermoset or thermoplastic polymer including the steps of placing an ionizable monomer solution in contact with a solid form of the hydrophobic thermoset or thermoplastic polymer; diffusing the ionizable monomer solution into the hydrophobic thermoset or thermoplastic polymer; and polymerizing the ionizable monomers to form a ionic polymer inside the hydrophobic thermoset or thermoplastic polymer, thereby forming the IPN or semi-IPN.

Abstract: An osteochondral implantable device is provided, comprising an upper cap and at least one insert comprising a non-polymeric material in physical contact with the upper cap, said lower insert comprising at least one non-polymeric material, wherein the porosity of the upper cap is greater than the porosity of the insert and the Young's modulus of the upper cap is smaller than the Young's modulus of the insert.

Abstract: A medical implant for cartilage repair at an articulating surface of a joint includes a contoured, substantially plate shaped, implant body and at least one extending post. The implant body has an articulate surface configured to face the articulating part of the joint and a bone contact surface configured to face the bone structure of a joint, where the articulate and bone contact surfaces face mutually opposite directions and the bone contact surface is provided with the extending post. A cartilage contact surface connects the articulate and the bone contact surfaces and is configured to contact the cartilage surrounding the implant body in a joint. The cartilage contact surface has a coating that substantially only includes a bioactive material.

Abstract: An implant device for humans or mammals has a body structure having an exposed surface and one or more selected portions of the exposed surface having a bone formation enhancing 3-dimensional pattern. The exposed surface can be on exterior portions of the body structure or internal portions of the body structure or both. The one or more selected portions of the exposed portions having the bone formation enhancing 3-dimensional patterns are in the external exposed surfaces or in the internal exposed surfaces or both internal and external exposed surfaces.

Abstract: Implantable medical devices and methods are provided that have one or more statins disposed therein. The medical devices may be implanted at near or in a bone defect to enhance bone growth. In some embodiments, the medical device provided allows for sustain release of the statin and facilitates bone formation and repair of the fracture site.

Abstract: The present invention provides polymeric substrates comprising a biocompatible coating and methods of preparation thereof. In particular, the coating may be a ceramic material, especially a calcium phosphate material, which may be functionally graded. The invention provides the ability to apply high quality coatings to polymeric substrates without damaging the substrate (e.g., melting the polymeric material). The functionally graded coating can provide crystalline calcium phosphate near the coating interface with the substrate and provide amorphous calcium phosphate at the outer surface of the coating.