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.

Abstract: The invention relates to a prosthesis for supporting a breast implant comprising: a reinforcement part configured to receive a curved lower portion of a breast implant, the reinforcement part having an elongation under 50N in the vertical direction of E1, a fixation part intended to be fixed to the pectoral muscle, the fixation part having an elongation under 50N in the vertical direction of E2, and a transition part connecting together the reinforcement part and the fixation part, said transition part having an elongation under 50N in the vertical direction of E3, wherein E3 is greater than E1 and greater than E2.

Abstract: The present invention relates to methods for bioresorbable and biodegradable casings having both micropores and macropores for providing shape, structure and containment to different bone grafting materials. Kits and methods of use are also described.

Abstract: The present invention relates to an intervertebral fusion device (10) comprising a superior component (12), an inferior component (14) and a core component (16). The superior component (12) and the inferior component (14) are receivable in an intervertebral space between first and second vertebrae with the core component (16) insertable between the superior and inferior components to determine a separation between the superior and inferior components. A bone graft conveying aperture is defined in at least one of a superior component top surface (18) of the superior component and an inferior component bottom surface (20) of the inferior component. The core component defines a bone graft material holding space which is enclosed except at at least one of a core component top surface and core component bottom surface of the core component and a bone graft material delivery opening. The bone graft material delivery opening extends from outside the core component side to the bone graft material holding space.

Abstract: An expandable intervertebral cage includes vertically opposed superior and inferior plates and longitudinally opposed distal and proximal wedges disposed between the plates. The wedges define ramps that engage complimentary ramps of the superior and inferior plates to increase a vertical distance between the plates. An actuator is located between the plates, defines a central, longitudinal axis, and is coupled to the wedges such that, as the actuator rotates about the axis, at least one of the wedges moves longitudinally relative to the other, thereby increasing the vertical separation distance. At least one locking component is insertable within a receptacle at least partially defined by the proximal wedge and is configured to transition from an unlocked configuration, where the actuator is rotatable relative to the proximal wedge, to a locked configuration, where the actuator is rotationally affixed relative to the proximal wedge.

Abstract: The present disclosure relates to a microgel composition comprising collagen and hyaluronic acid and a method of preparing the same. The microgel according to an embodiment is composed of natural biocompatible substances and is non-toxic and has high mechanical stability or long persistence, and thus can be effectively used in a microgel composition, a three-dimensional scaffold composition, and a tissue-engineering scaffold.

Abstract: An apparatus and method are disclosed for a biofunctional molecular imprint medical device configured to remain in permanent or temporary contact with a body comprising a supportive structure, a surface material that receives and retains a molecular imprint and that is positioned to contact a body tissue or other substance during use, a molecular imprint of a bioactive molecule wherein an imprinted cavity is of a bioactive molecule that catalyzes the promotion or suppression biological processes and at least one of a semiconductor, a nanoparticle quantum dot, a nano-island, and a quantum wire, wherein the nanoparticle quantum dot, nano-island, or quantum wire produces an electron wave function configuration that dynamically reconfigures the electron charge distribution within the molecular imprint, enabling tuning of the imprinted cavity.

Abstract: The present invention relates to a device for guided bone regeneration, intended for the reconstruction of a buccal bone defect, composed of zirconium dioxide and having a shape which covers said buccal bone defect. The present invention also relates to a method for producing a device of the invention, comprising a step of constructing the device of the invention according to a three-dimensional representation obtained by means of a technique of maxillo-dental imaging of the bone defect.

Abstract: An intravascular device for treating a cerebral aneurysm which has an externally controllable expandable member, the expandable member has a plurality of wires that define walls of the expandable member; where in a relaxed state of the expandable member the walls have at least a first wall portion in which openings defined between the wires are small enough to prevent coils positioned within the aneurysm from exiting the aneurysm, the first wall portion has an axial length at least as long as a neck of the aneurysm; and at least a second wall portion in which openings defined between the wires are large enough to allow blood flow through; the second wall portion axially aligned relative to the first wall portion.

Abstract: Methods for improving the antibacterial characteristics of biomedical implants and related implants manufactured according to such methods. In some implementations, a biomedical implant comprising a silicon nitride ceramic material may be subjected to a surface roughening treatment so as to increase a surface roughness of at least a portion of the biomedical implant to a roughness profile having an arithmetic average of at least about 500 nm Ra. In some implementations, a coating may be applied to a biomedical implant. Such a coating may comprise a silicon nitride ceramic material, and may be applied instead of, or in addition to, the surface roughening treatment process.

Abstract: Embodiments described include devices and methods for forming a porous polymer material. Devices disclosed and formed using the methods described a spacer for spinal fusion, craniomaxillofacial (CMF) structures, and other structures for tissue implants.

Abstract: An engineered medical device for treatment of osteonecrosis is provided where the size, porosity and ceramic content of the device can be personalized based on an individual patient's anatomical and physiological condition. The device distinguishes different segments mimicking anatomically-relevant cortical and cancellous segments, in which the cortical segments of the device can sustain mechanical loading, and the cancellous segment of the device can promote bone ingrowth, osteogenesis and angiogenesis.

Abstract: Systems featuring two or more encapsulation devices stacked together. The encapsulation devices house cells, such as but not limited to islet cells or stem cell derived beta cells or the like. e.g., for regulating blood glucose, or other cells or spheroids that can produce and release a therapeutic agent that is useful in the body, etc. The system may feature oxygen delivery, or in some cases no exogenous oxygen is delivered and vascularization of the device can help provide oxygen and other needed nutrient to the cells. The system of the present invention may be used in conjunction with other therapies such as an artificial pancreas. Stacking the devices with blood vessel formation around and in between them may allow for a decrease in the footprint that would be needed for implantation.

Abstract: The invention relates to a connecting sleeve for anchoring shafts of two oppositely arranged prostheses, preferably on an elongate bone such as a femur or humerus. The reinforcing sleeve comprises two receiving bushes (1, 2) for one prosthesis shaft each and comprises a separable coupling region (3) arranged therebetween for connection in such a manner as to resist shear forces and rotation. According to the invention, each receiving bush (1, 2) has, on the side thereof facing the coupling region, one fork (31, 32) of a pair of forks that interact with each other, and a fitting block (4) is arranged on a base of the fork, the lateral surfaces (44) of which fitting block have a distance that corresponds to an inner width of the fork, and the lateral surfaces (44) are designed to contact flanks of the fork in a planar manner, at least one fastening screw (5) being arranged transversely through the fork. The fork connection is simpler to produce than the known wedge connection and yet is sufficiently robust.

Abstract: The present disclosure relates to a dynamic bioactive bone graft material having an engineered porosity. In one embodiment, a bone graft material is provided having bioactive glass fibers arranged in a porous matrix that is moldable into a desired shape for implantation. The material can be substantially without additives and can include at least one nanofiber. The porous matrix may include a combination of one or more pore sizes including nanopores, macropores, mesopores, and micropores. In another embodiment, a bone graft implant is provided having a matrix comprising a plurality of overlapping and interlocking bioactive glass fibers, and having a distributed porosity based on a range of pores provided in the bioactive glass fibers. The distributed porosity can comprise a combination of macropores, mesopores, and micropores, and the matrix can be formable into a desired shape for implantation into a patient.

Abstract: A composite implant comprising a bioabsorbable matrix material, an outer sheath of a textile comprising filaments; and a plurality of flexible reinforcing rods held together by the outer sheath; each of the flexible reinforcing rods have a plurality of filaments, and the filaments of the textile and the flexible reinforcing rods include a degradable or resorbable glass. Preferably, the filaments are present in the composite implant in an amount of 20 volume percent to 95 volume percent, based on the total volume of the composite implant.

Abstract: Methods for generating serum-free and/or xenogen-free cardiac explant-derived stem cells (EDC) are provided. These methods may include providing an initial cardiac explant, which has been minced and digested; plating the initial cardiac explant; culturing the plated cardiac explant in serum-free and xenogen-free medium; harvesting EDC cells surrounding or emerging from the plated cardiac explant; and optionally performing static expansion of harvested EDC cells in serum-free and xenogen-free media. Serum-free and/or xenogen-free cardiac EDC cells produced by these methods, as well as methods and uses thereof for the treatment of heart failure in a subject in need thereof, are also provided.

Abstract: Scaffolds for use in bone tissue engineering include a skeleton and a host component. Methods of preparation of scaffolds include identification of biodegradation properties for the skeleton and the host component. The skeleton is constructed to form a three-dimensional shape. The skeleton is constructed of a first material and has a first rate of biodegradation. The host component fills the three-dimensional shape formed by the skeleton. The host component is constructed of a second material and has a second rate of biodegradation. The first rate of biodegradation is slower than the second rate of biodegradation.

Abstract: The present disclosure relates to compositions useful in synthetic bone graft applications. Particularly, the disclosure teaches moldable bone graft compositions, methods of making said compositions, and methods of utilizing the same.

Abstract: Flowable matrix compositions and methods of their use and manufacture are provided. Exemplary compositions may include a flowable, syringeable, putty-like form of acellular human dermal matrix. In some cases, compositions may include a moldable acellular collagen extracellular matrix. In use, the matrix compositions can be used to fill or treat skin voids, channel wounds, and other soft tissue deficiencies.

Abstract: Flowable matrix compositions and methods of their use and manufacture are provided. Exemplary compositions may include a flowable, syringeable, putty-like form of acellular human dermal matrix. In some cases, compositions may include a moldable acellular collagen extracellular matrix. In use, the matrix compositions can be used to fill or treat skin voids, channel wounds, and other soft tissue deficiencies.

Abstract: A method of forming an implantable tissue engineered construct, a bioreactor for forming a tissue engineered construct, and a tissue engineered construct itself are disclosed The method includes seeding a scaffold with cells to form a tissue construct; locating the tissue construct in a space defined by a tissue construct support element; locating the tissue construct support element within a bioreactor; and operating a load applicator of the bioreactor to apply a cyclical compressive mechanical load to the tissue construct, to stimulate the deposition of tissue matrix in the tissue construct, in which the tissue construct, the tissue construct support element and the load applicator are arranged so that the load applicator can at least initially contact both the tissue construct and the tissue construct support element, so that at least part of a total load generated by the load applicator is borne by the tissue construct support element.

Abstract: There is disclosed a synthetic, composite graft to support robust bone growth. In an embodiment, the synthetic, composite graft includes a synthetic scaffold material including a material resorbable through natural cellular processes; a signaling factor combined with the scaffold material; a cell adherence factor coated on the scaffold material; a quantity of viable bone forming cells adhered to the scaffold; and a matrix substrate binding the scaffold material. There is disclosed a method of forming a synthetic, composite graft to support bone growth for bone grafting. In one embodiment, the method includes providing a synthetic scaffold material including a material resorbable through natural cellular processes; combining a signaling factor with the scaffold material; coating a cell adherence factor on the scaffold material; adhering a quantity of viable bone forming cells to the scaffold; and encasing the scaffold material with a matrix substrate. Other embodiments are also disclosed.

Abstract: The invention provides a method and apparatus for cranial fixation following a craniotomy and treatment for increased intracranial pressure. The cranial fixation device comprises of plates attached to the skull with a telescopic screw. The telescopic screw provides constrained movement of the bone flap relative to the skull to accommodate an increase in the intracranial pressure.

Abstract: The present invention relates to a composition comprising, or consisting of 2-50 mg/ml hyaluronic acid, 0.1-500 mg/ml of biodegradable particles with an average mean particle diameter of 1 nm-500 ?m, 1 pg/ml-10 ?g/ml cytokines, where the concentrations specified are based in each case on the total volume (w/v) of the composition and where the cytokines are enclosed in the biodegradable particles, and to their use in the treatment of cartilage defects, for example traumatic cartilage defects or osteoarthrosis.

Abstract: This invention includes a subchondral bone repair system, comprising a structural component and a fluid settable component and an optional non-core component. The fluid settable component may penetrate into any pores of the structural component, and set to a solid, thereby fixing the structural component in place. The fluid settable component will penetrate interporously into the pores of the subchondral bone tissue surrounding the device, beneficially displacing any fluid to reduce edema in the affected bone region. Furthermore, the settable component, once solid is osteoconductive to promote repair and regrowth of bone in the affected region, and will also transmit mechanical force stimuli (such as compressive forces) directed through the structural component, into the adjacent bone tissue, thereby providing appropriate force stimuli necessary for appropriate tissue growth.

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: Devices and methods for transplanting cells in a host body are described. The cell comprises a porous scaffold that allows ingrowth of vascular and connective tissues, a plug or plug system configured for placement within the porous scaffold, and a seal configured to enclose a proximal opening in the porous scaffold. The device may further comprise a cell delivery device for delivering cells into the porous scaffold. The method of cell transplantation comprises a two step process. The device is incubated in the host body to form a vascularized collagen matrix around a plug positioned within the porous scaffold. The plug is then retracted from the porous scaffold, and cells are delivered into the vascularized space created within the porous scaffold.

Abstract: Phosphorus-based coatings having a plurality of phosphate moieties, a plurality of phosphonate moieties, or both, covalently bonded to an oxide surface of an implantable substrate exhibiting one or more of the following characteristics: (a) the surface phosphorus-containing group density of the coated regions of the substrate is at least about 0.1 nmol/cm2; (b) the phosphorus-based coating has a thickness of less than about 10 nm; or (c) the surface phosphorus-containing group density of the coated regions of the substrate is equal to or greater than the surface hydroxyl group density of the oxide surface of the substrate. Implantable devices embodying the coated substrates are also disclosed.

Abstract: Bioactive implant for myocardial regeneration and ventricular chamber support including an elastomeric microporous membrane. The elastomeric microporous membrane being at least one non-degradable polymer and at least one partially degradable polymer. The non-degradable polymer is selected from polyethylacrylate and polyethylacrylate copolymerized with a hydroxyethylacrylate comonomer. The partially degradable polymer is selected from caprolactone 2-(methacryloyloxy)ethyl ester and caprolactone 2-(methacryloyloxy)ethyl ester copolymerized with ethylacrylate. The elastomeric microporous membrane further includes a nanofiber hydrogel, and cells. The bioactive implant, having one or two helical loops, contributes to the restauration of the heart conical shape.

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 drug-impregnated sleeve for encasing a medical implant is provided. In one embodiment, the sleeve may include a body made of a biologically-compatible material that defines an internal cavity configured to receive the medical implant. In one embodiment, the biologically-compatible material is bioresorbable. The body may include a plurality of apertures, such as perforations or holes, extending from the cavity through the body. The sleeve may further include a first end, a second end, and a drug impregnated into the resorbable sheet. In one possible embodiment, the first end of the sleeve may be open for receiving the medical implant therethrough and the second end may be closed. The implant may be encased in the sleeve and implanted into a patient from which the drug is dispensed in vivo over time to tissue surrounding the implantation site. In one embodiment, the body is made from at least one sheet of a biologically-compatible material.

Abstract: A cell-support matrix having narrowly defined uniformly vertically and non-randomly organized porosity and pore density and a method for preparation thereof. The matrix suitable for preparation of cellular or acellular implants for growth and de novo formation of an articular hyaline-like cartilage. A gel-matrix composite system comprising collagen-based matrix having a narrowly defined porosity capable of inducing hyaline-like cartilage production from chondrocytes in vivo and in vitro.

Abstract: The present invention relates to protein matrix materials and devices and the methods of making and using protein matrix materials and devices. More specifically the present invention relates to protein matrix materials and devices that may be utilized for various medical applications including, but not limited to, drug delivery devices for the controlled release of pharmacologically active agents, encapsulated or coated stent devices, vessels, tubular grafts, vascular grafts, wound healing devices including protein matrix suture material and meshes, skin/bone/tissue grafts, biocompatible electricity conducting matrices, clear protein matrices, protein matrix adhesion prevention barriers, cell scaffolding and other biocompatible protein matrix devices. Furthermore, the present invention relates to protein matrix materials and devices made by forming a film comprising one or more biodegradable protein materials, one or more biocompatible solvents and optionally one or more pharmacologically active agents.

Abstract: The present invention relates to an implant system comprising implantable material in at least partially uncured form, contained in a closed casing, under vacuum and sterilized, and a closed bag containing the casing. The system is characterized in that at least 5% of the surface of the casing comprises sheet-like material having a thickness of 0.05-5 mm and having an original form, the sheet-like material being selected from the group consisting of metallic materials, polymers, bioceramic materials and composites thereof, provided that the material, once deformed from its original form to a changed form, is capable of maintaining that changed form unless subjected to external forces.

Abstract: A method of treating a biological tissue for biological prostheses includes steps of fixation of the biological tissue via a fixing solution including glutaraldehyde and detoxification of the fixed biological tissue via treatment with a detoxifying solution. The detoxification step includes one or both of eliminating phospholipids via treatment with an elimination solution and a treatment with a detoxifying solution. The elimination solution includes 1,2-octanediol and ethanol. The detoxifying solution includes taurine or homocysteic acid.

Abstract: A vascular prosthesis comprising a tubular shaped expandable ECM member and at least one anchoring mechanism. In one embodiment, the anchoring mechanism comprises proximal and distal single or dual-ring anchors. In one embodiment, the anchoring mechanism comprises a multiple-ring anchor. The anchors preferably comprise a biodegradable metal, such as magnesium. The anchors can also comprise a shape memory alloy, such as nitinol, and a cross-linked ECM material. In some embodiments, the ECM member includes a pharmacological agent.

Abstract: A laminated, bioimplantable dural graft product is configured for use as both an onlay graft and a suturable graft. The dural graft product is sufficiently pliable so as to sufficiently conform to a curvature of a tissue surface to which it is applied, such as the curved surface of a meningeal membrane. The use of the graft product can have improved properties, including suture retention strength and fluid impermeability. To use the dural graft product as an implant to replace, reinforce or strengthen bodily tissue, or to act as an adhesion barrier, the dural graft is placed in contact with bodily tissue and conforms to the curvature of the bodily tissue. Sutures can be used to maintain the contact between the dural graft and the bodily tissue.

Abstract: This invention provides aragonite- and calcite-based scaffolds for the repair, regeneration, enhancement of formation or a combination thereof of cartilage and/or bone, which scaffolds comprise at least two phases, wherein each phase differs in terms of its chemical content, or structure, kits comprising the same, processes for producing solid aragonite or calcite scaffolds and methods of use thereof.

Abstract: An extracellular matrix (ECM) construct having a biodegradable support scaffold that includes a plurality of biodegradable microneedles that are capable of piercing tissue and anchoring therein, and at least a first layer of first ECM material disposed on the top surface of the support scaffold.

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: A method and apparatus for replacing damaged meniscal tissue includes a meniscus implant including a porous body having a plurality of interconnected open micro-pores and one or more open cavities for receiving meniscal tissue. The interconnected micro-pores are arranged to allow fluid to flow into the porous body and are in fluid communication with the one or more open cavities.

Abstract: Bio-implantable textured tubular and sheet structures of un-sintered ePTFE are described. Such micro-textured structures stimulate robust development of beneficial bio-integrative scar attachment to adnexal soft tissues. Methods for texturing one side of an un-sintered extruded ePTFE tube or sheet are also described. A select length of tubing of any thickness or diameter is applied over a matching mandrel and adhesively stabilized thereon by applying intense suction. The texture is made by “RIGDA tooling” into the wall thickness of the material and by removing undesired material by distraction and avulsion tooling and methods assisted by vibration, leaving intact the finished product. Disclosed is an implantable, non-attached, enveloping, conforming and supportive drainage cover for breast and other soft implants.

Abstract: Inkjet print head dies are directly seated upon an exterior of a tubular member so as to face different directions.

Abstract: A bioerodible conductive tissue scaffold that can provide, e.g., improved tissue growth.

Abstract: An anti-adhesion sheet for placement upon the anterior wall of a vertebral body, wherein the sheet has a radius of curvature that is less than that of the anterior wall of the vertebral body.

Abstract: Described herein are tissue repair implants comprising at least a first layer of peritoneal membrane. The first layer of peritoneal membrane can be located adjacent to a second layer of peritoneal membrane and can be in direct contact with the second layer of peritoneal membrane. Additional layers (e.g., a third or fourth layer) can be included. Where more than one layer is present, the layers can be affixed to one another. For example, a first layer of peritoneal membrane can be attached to the second layer of peritoneal membrane by an adhesive bond, suture, or staple. One or more of the peritoneal membranes can be non-crosslinked, partially crosslinked, or substantially fully crosslinked. Any of the layers of peritoneal membrane may be attached to a wall (e.g., an interior or exterior wall) of an abdominal tissue by an adhesive, suture, and/or staples.

Abstract: The invention relates to medical devices that has a surface configured to promote the migration of cells onto the surface of the medical device. In particular, the surface of the medical device has a noncontiguous pattern of topographical features formed therein or thereon.

Abstract: A medical device configured to be at least partially implanted within a host. The medical device includes an outer surface at least a portion of which is impermeable to cells but is permeable to molecules secreted by cells, the outer surface separating a space inside the medical device from a surrounding tissue of the host. The medical device also includes a diffusion sink positioned within the space and configured to cause molecules that are secreted into the tissue by immune cells during a foreign body response (FBR) to diffuse, through random motion, through the portion and into the diffusion sink.

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.