Abstract: Methods and devices are provided for regenerating a meniscus. The devices comprise a layer of toughened naturally occurring extracellular matrix. The devices may, optionally, further comprise a biologic material to provide a framework for meniscus regeneration. The methods comprise the steps of removing a portion of a meniscus to provide a space, and inserting a device comprising a layer of toughened naturally occurring extracellular matrix into the space.

Abstract: A shunt rivet for implementation in the aorta and inferior vena cava to treat chronic obstructive pulmonary disease, and a method of treating chronic obstructive pulmonary disease.

Abstract: A medical device for implantation into vessels or luminal structures within the body is provided, which stimulates positive blood vessel remodeling. The medical device, such as a stent and a synthetic graft, is provided with a coating with a pharmaceutical composition containing a controlled-release matrix and one or more pharmaceutical substances for direct delivery of drugs to surrounding tissues. The coating on the medical device further comprises one or more barrier layers, and a ligand such as a peptide, an antibody or a small molecule for capturing progenitor endothelial cells in the blood contacting surface of the device for restoring an endothelium at the site of injury. In particular, the drug-coated stents are for use, for example, in balloon angioplasty procedures for preventing or inhibiting restenosis.

Abstract: A graft containing a scaffold that includes a matrix in which are positioned mesenchymal progenitor cells (MPCs) has the capacity to substantially improve wound healing, including wounds resulting from injury to nerve, bone and vascular tissue. MPCs can be harvested from debrided muscle tissue following orthopaedic trauma. The traumatized muscle-derived progenitor cells are a readily available autologous cell source that can be utilized to effect or improve wound healing in a variety of therapeutic settings and vehicles.

Abstract: Implants include a porous layer made from a composition including a compound wherein collagen is cross-linked to a glycosaminoglycan, the porous layer being optionally joined to a collagen film.

Abstract: Disclosed are biomedical scaffolds that may be used, for example, for treatment of bone diseases and bone repair. Methods of preparing such scaffolds are also disclosed. These scaffolds permit nutrient and ion flow such that bone regeneration in the area surrounding the scaffold is promoted. Also disclosed are kits that include the scaffolds set forth herein.

Abstract: An engineered three-dimensional structure includes living cells cohered with each other. The living cells suitably include Schwann cells and at least one other type of cell. The cells accompanying the Schwann cells can suitably be bone marrow stem cells or another type of cell having one or more anti-inflammatory properties. The structure is suitably a graft that facilitates restorative axon growth when the graft is implanted between the proximal and distal stubs of a severed nerve in a living organism. The graft can optionally include a plurality of acellular conduits extending between opposite axial ends of the graft. Bio-printing techniques can be used to assemble a three-dimensional construct that becomes through maturation an axon-guiding graft, by stacking a plurality of multicellular bodies, each of which includes a plurality of living cells cohered to one another to sufficiently to avoid collapsing when the multicellular bodies are stacked to form the structure.

Abstract: A membrane for implantation in soft tissue comprising a first domain that supports tissue ingrowth, disrupts contractile forces typically found in a foreign body response, encourages vascularity, and interferes with barrier cell layer formation, and a second domain that is resistant to cellular attachment, is impermeable to cells and cell processes, and allows the passage of analytes. The membrane allows for long-term analyte transport in vivo and is suitable for use as a biointerface for implantable analyte sensors, cell transplantation devices, drug delivery devices, and/or electrical signal delivering or measuring devices. The membrane architecture, including cavity size, depth, and interconnectivity, provide long-term robust functionality of the membrane in vivo.

Abstract: A hyaline-like, single layer cartilage tissue construct includes chondrogenic cells dispersed within an endogenously produced extracellular matrix. The single layer cartilage tissue construct has a glycosaminoglycan content substantially equal to the glycosaminoglycan content of native cartilage tissue. A method for generating a single layer cartilage tissue construct includes isolating a population of chondrogenic cells and then expanding the population of chondrogenic cells. Next, the population of chondrogenic cells is seeded into a bioreactor having a volume defined by oppositely disposed gas permeable membranes. The population of chondrogenic cells is then cultured in a serum-free culture medium for a time sufficient to permit the population of chondrogenic cells to differentiate and form the single layer cartilage tissue construct.

Abstract: A composite implant includes an anisotropic surgical mesh having more stretchability along a first axis and less stretchability along a second axis that traverses the first axis, and an alignment marker overlying a first major surface of the anisotropic mesh and extending along the first axis. The implant includes a first absorbable, anti-adhesion film overlying the alignment marker and the first major surface of the anisotropic mesh, and a second absorbable, anti-adhesion film overlying the second major surface of the biocompatible mesh. The alignment marker is disposed between the first and second absorbable films and the first and second absorbable films are laminated to the anisotropic mesh.

Abstract: A transitional mesh and thread for use in the human body is dissolved. The transitional mesh being comprised of sections of non-absorbable mesh fabric with sections of absorbable mesh fabric, such that each non-absorbable section is attached to absorbable mesh fabric. The non-absorbable mesh sections can be overlaid with absorbable mesh which after it is absorbed leaves the non-absorbable mesh in an array without connection to each other. The thread to be used to create the mesh has non-absorbable fibers that can be discontinuous, loosely woven or embedded in an absorbable material. The fabric mesh itself can be loosely woven and coated with absorbable material. The patterns of non-absorbable mesh and space between non-absorbable mesh sections can be varied to provide various strengths and degrees of motion and movement. The mesh can also be coated with materials to reduce infection, provide tissue growth, reduce scar tissue or other medicinal purposes.

Abstract: Apparatus and methods for closing a septal defect including a flap of tissue partially detached from a septum of a heart. A needle is advanced through a patient's vasculature within a delivery apparatus until the needle is disposed within a first chamber adjacent the septum. The needle is directed through the flap of tissue until the needle is disposed within a second chamber opposite the septum. A filament attached to an intermediate region of the needle is pulled, thereby causing the needle to pivot about the intermediate region such that the ends of the needle straddle the septal opening. A locking element is secured to the filament to secure the flap of tissue against the septum, and the filament is cut. Alternatively, the filament is biased to coil to engage the flap of tissue and secure the needle against the septum to close the opening.

Abstract: A method for use of a double-structured tissue implant or a secondary scaffold stand alone implant for treatment of tissue defects. The double-structured tissue implant comprising a primary scaffold and a secondary scaffold consisting of a soluble collagen solution in combination with a non-ionic surfactant generated and positioned within the primary scaffold. A stand alone secondary scaffold implant or unit.

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 device useful for treating an aneurysm having a neck comprises a first inflatable disc and a second inflatable disc, said second inflatable disc being adjacent to said first inflatable disc and in fluid communication therewith. The inflatable discs are sized and constructed such that when the inflatable discs are inflated, the aneurysm neck is engaged there between. The inflatable discs may include at least one wall that is substantially inelastic and may include an internal member limiting expansion of the inflatable disc in a direction parallel to the device axis. The inflatable discs may have an aspect ratio greater than 3.

Abstract: A hernia prosthesis includes a first portion defining a bag joined to a second portion constituting a one-piece body. A top plate of the first portion has a plurality of radial tabs around a central opening. The second portion has three distinct successive zones including a first median zone in the form of a very long sheath for introducing and securing an inserter-unfolder device. The median portion is prolonged downwards by a plurality of bands uniformly radially disposed and having bottom ends divided into two each respectively to form two tongues in a Y fastening configuration. Each tongue is fastened by its terminal end to one of the tabs. The second portion, in a top zone, beyond the sheath, comprises two very high tongues which have, in their top portion, a longitudinal slit in their width for attaching the inserter-unfolder device.

Abstract: The first aspect of the present invention is directed to a method of producing a vascular network preform (VNP). This method involves forming a network of elongate fibers and at least one elongate structure from a sacrificial material. The diameter of the elongate structure is greater than that of the elongate fibers. The network of elongate fibers is placed in contact with at least one elongate structure either following or during forming the network of elongate fibers or forming the at least one elongate structure. A matrix is applied around the network of elongate fibers, in contact with the at least one elongate structure. The network of elongate fibers and elongate structure, within the matrix is sacrificed to form a preform. The resulting preform contains a vascular network of fine diameter tubes in contact with at least one elongate passage having a diameter greater than that of the fine diameter tubes. The resulting solid preform and methods of using it are also disclosed.

Abstract: The present invention discloses an artificial nerve graft prepared by electrostatic spinning, the preparing method and a special apparatus used therefor. Said artificial nerve graft is in the shape of a tube composed of nano-fiber that is prepared by electrostatic spinning of a polymer. The materials used in the present invention are bio-degradable materials and of desirable biocompatibility with human body. The product of the present invention is free of exogenous toxic substances or substances having side effects. Furthermore, the tube wall is of a 3-dimensional structure having micropores contained therein thereby providing a path for supplying nutritions required for the growth of nerve cells. Another advantage of the present invention is that necessary induction and space are provided for the growth of the nerve cells.

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: The invention provides a highly aligned and closely packed hollow fiber assembly, wherein the assemblies of fibrous membrane has a width-to-fiber diameter ratio (W/d) larger than 10 and the orientation of the fibers is no larger than +/?10°. Also provided is an electrospinning process for the preparation of the fiber assembly of the invention and its applications.

Abstract: Fenestrated wound repair scaffolds and methods for forming scaffolds involve dispersing human collagen having a preserved amount of native constituents in solution, depositing the human collagen dispersion in a tray, forming openings in the collagen dispersion and removing the liquid component to form a fenestrated wound repair scaffold. Fenestrated wound repair scaffolds include a network of openings passing linearly through the wound repair scaffold to form channels for cells to pass into so as to form a series of cell formations therein.

Abstract: The present invention provides for compositions and constructs for craniofacial reconstruction implants, and methods for making and using same. Specific embodiments provide for a biocompatible scaffold having an auricular shape and a permanent bendable framework within the scaffold, wherein the permanent bendable framework allows deformation and return to pre-deformation shape, and thus maintains the auricular shape of the scaffold.

Abstract: Methods and apparatus for use in repairing an atrioventricular valve in a patient are provided. The methods comprise accessing the patient's atrioventricular valve percutaneously, securing a fastening mechanism to a valve leaflet, and coupling the valve leaflet, while the patient's heart remains beating, to at least one of a ventricular wall adjacent the atrioventricular valve, a papillary muscle, at least one valve chordae, and a valve annulus to facilitate reducing leakage through the valve.

Abstract: The invention relates to a prosthetic system (1) that can implanted in a human or animal body, wherein said system (1) includes a substrate (2) to be brought into contact with a biological tissue (4), and an adhesive (3) for bonding said substrate (2) onto the biological tissue (4), said system (1) being characterised in that the adhesive (3) contains as an adhesive substance at least one hydrocolloid. The invention can be used for prosthetic implants.

Abstract: A biocompatible surgical scaffold made from a multi-filament silk yarn for soft tissue reconstruction. The scaffold incorporates regions of varying stretch having different physical and mechanical properties that allow contouring to the required soft tissue shape to be replaced or repaired. The porous structure allows tissue in-growth, while the mesh degrades at a rate which allows for a smooth transfer of mechanical properties to the new tissue from the silk scaffold.

Abstract: It is intended to provide a medical material which enables a new method for cartilage tissue regeneration treatment based on an entirely new concept unlike a treatment method by transplantation of autologous cartilage tissue, a cartilage alternative or undifferentiated cells. The invention provides a bone filler for cartilage tissue regeneration comprising hydrogel having an interpenetrating network structure formed by two or more crosslinked network polymers or a semi-interpenetrating network structure formed by a crosslinked network polymer and a linear polymer. By filling the bone filler of the invention in a hole or a groove provided in subchondral bone just under damaged cartilage tissue, regeneration of the cartilage tissue or both the cartilage tissue and the subchondral bone can be promoted.

Abstract: An improved non-toxic soft tissue filler is provided. The soft non-toxic tissue filler consists of spherically shaped solid particles having a textured surface of a size range of between about 32 and 90 microns (depending on the concentration that is desired). The particles are suspended evenly in a gel as a carrier. The solid particles are preferably a non-ceramic cured polymer such as polymethylmethacrylate (PMMA). The gel is a combination of a cellulose polysaccharide such as carboxymethylcellulose (CMC) and an alcohol such as polyvinyl alcohol (PVA) dissolved in water or some other solvent. The filler is used by injection in order to augment a patient's soft tissue as well as to correct soft tissue defects.

Abstract: Implants for tissue repair/regeneration include a porous layer combined with dry materials that are activated to form a hydrogel upon contact with aqueous physiological fluids.

Abstract: The present invention relates generally to medical methods and systems used to restore the angle of His and treat hiatal hernias and other conditions of the lower esophagus. More particularly, the present invention relates to a method and system that allows fixation of the distal esophagus and fundus of the stomach directly to the diaphragmatic crus muscle. The present invention provides a method where the diaphragmatic crus muscle is identified and precisely located from within and through the gastrointestinal lumen followed by the placement of a translumenal anchor which connects and secures the esophagus and stomach to the diaphragmatic crus muscle. This procedure reduces the hiatal hernia, restores the normal anatomy and treats conditions associated with the lower esophagus.

Abstract: The invention in some aspects provides implantable articles comprising in vitro-prepared tissues for joint repair. Devices and methods for introducing implantable articles into a subject are also provided. In some aspects of the invention devices and systems for minimally invasive surgery are provided. In some aspects, methods are provided for regenerating a bone-tendon interface in a subject by implanting an in vitro-prepared tissue between a detached tendon or detached ligament and a bone in a subject. In other aspects, methods are provided for maintaining exogenous, viable fibroblasts between a detached tendon and a bone in a subject. In other aspects, methods are provided for delivering exogenous cytokines and/or growth factors to a damaged bone-tendon interface.

Abstract: Surgical implants which include a biocompatible substrate and at least one grip member capable of transitioning between a first non-gripping configuration and a second gripping configuration.

Abstract: The present invention provides a tissue repair scaffold comprising a secondary fibre bundle, the secondary fibre bundle comprising a plurality of primary fibre bundles, each primary fibre bundle comprising a plurality of fibres, wherein the fibres comprise a biocompatible polymer. In embodiments the biocompatible polymer is polycaprolactone (PCL) (also known as poly-?-caprolactone) and the average diameter of the fibres is less than 1 ?m. The scaffold is particularly adapted for tendon repair. In vivo mouse studies demonstrate that tendon repair can be achieved with normal ambulation returning after 24-48 hours. The scaffolds were easy to handle during surgery, being non-slippery and easy to suture in place.

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: This invention relates to processes of preparing heterogeneous graft material from animal tissue. Specifically, the invention relates to the preparation of animal tissue, in which the tissue is cleaned and chemically cross-linked using both vaporized and liquid cross-linking agents, resulting in improved physical properties such as thin tissue and lowered antigenicity, thereby increasing the ease of delivering the tissue during surgery and decreasing the risk of post-surgical complication, respectively.

Abstract: A semi-permeable membrane can be used to promote the surgical repair of cartilage in a damaged or diseased joint, such as a knee, hip, or shoulder. In one method, the semi-permeable membrane is secured to the “articulating” surface (the exposed surface, as opposed to the “anchoring” surface which rests on a condyle) of a resorbable fibrous matrix that has been seeded, before implantation, with chondrocyte or similar cells that generate cartilage. A membrane used in this manner can help protect the cells as they grow, reproduce, and secrete new cartilage inside the resorbable matrix. In another method, the semi-permeable membrane is secured to a slightly damaged surface of a cartilage segment that is suffering from a condition known as chondromalacia, without using an underlying implanted matrix or other device.

Abstract: A resorbable polymeric mesh implant is provided for use in the reconstruction of soft tissue defects. The mesh implant is provided with an interlocking knitted structure comprising two or more sets of fibers with different times of degradation, allowing a stepwise increase in the relative distension of the overall mesh over time. The filamentous fibers are knitted together, wherein the filaments of the first set of fibers are interlaced into the filaments of the second set of fibers and at least partly traverse the knit pattern of the second set of fibers such that the filaments of the first set of fibers lock the movement of the part of the mesh formed by the second set of fibers.

Abstract: A cartilage plug (14) comprises cross-linked polyvinylalcohol, a polyvinylalcohol fibre and fumed silica. The plug may also include chondrocytes and/or hyaluronic acid.

Abstract: The present invention relates to a method for promoting blood vessel formation in tissues and organs. In particular, the method relates to implantation or attachment of an engineered three-dimensional stromal tissue to promote endothelialization and angiogenesis in the heart and related tissues. The three-dimensional stromal tissue of the present invention may be used in a variety of applications including, but not limited to, promoting repair of and regeneration of damaged cardiac muscle, promoting vascularization and healing during cardiac surgery, promoting blood vessel formation at anastomosis sites, and promoting vascularization and repair of damaged skeletal muscle, smooth muscle or connective tissue.

Abstract: The invention involves a submucosa tissue that has the capability of being shape formed or shape configured. The submucosa involves a purified form of submucosa tissue. Optionally, the submucosa can be packaged in such a manner to permit sterility or maintain sterility of the submucosa.

Abstract: Devices and methods for treating or repairing openings in an body wall are provided. The devices and methods can include acellular tissue matrices. The tissue matrices can be positioned within the abdominal opening and can be used to close the opening.

Abstract: A patch for repairing an intra-abdominal defect is disclosed in one embodiment of the present invention as including a mesh layer providing a grid of material perforated by apertures through the mesh. This mesh is used to reinforce an area around an intra-abdominal defect. A containment layer is secured proximate an edge of the mesh layer. A filler is distributed across the apertures of the mesh to contain a fluid from passing through the mesh. The mesh layer, containment layer, and filler are connected to form a chamber to selectively expand upon receipt of a quantity of fluid between the containment layer and the filler.

Abstract: Implantable biomaterials, particularly hydrogel substrates with porous surfaces, and methods for enhancing the compatibility of biomaterials with living tissue, and for causing physical attachment between biomaterials and living tissues are provided. Also provided are implants suitable for load-bearing surfaces in hard tissue repair, replacement, or augmentation, and to methods of their use. One embodiment of the invention relates to an implantable spinal disc prosthesis.

Abstract: The present application is directed to engineering of tissues, especially composite tissues such as a joint. Various aspects of the application provide tissue modules and methods of fabrication and use thereof. Some embodiments provide a tissue module that can be fabricated to be substantially similar in anatomic internal and external shape as a target tissue. Some embodiments provide a composite tissue module having a plurality of layers, each of which simulate a different tissue (e.g., bone and cartilage of a joint).

Abstract: The invention is directed toward a sterile cartilage defect implant material comprising milled lyophilized allograft cartilage pieces ranging from 0.01 mm to 1.0 mm in size in a bioabsorbable carrier taken from a group consisting of sodium hyaluronate, hyaluronic acid and its derivatives, gelatin, collagen, chitosan, alginate, buffered PBS, Dextran or mixed polymers with allograft chondrocytes added in an amount ranging from 2.5×105 to 2.5×107.

Abstract: Described herein are open celled foams including a matrix of interconnected spheres. Also described herein are methods of making open celled foams as well as making composite members with open celled foam coatings covering at least a portion of the composite member. The open celled foams described herein are silicone based materials and can be used to coat implants such as breast implants and function to encourage tissue ingrowth and reduce capsular formation.

Abstract: This invention relates to reticulated elastomeric matrices, their manufacture, their post-processing, such as their reinforcement, compressive molding or annealing, and uses including uses for implantable devices into or for topical treatment of patients, such as humans and other animals, for surgical devices, tissue augmentation, tissue repair, therapeutic, nutritional, or other useful purposes.

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: An implantable prosthesis for repairing or reinforcing a tissue or muscle wall defect including a first composite structure including at least one layer of a non-absorbable material, wherein the first composite structure has a central portion sized and shaped to cover at least a portion of the tissue or muscle wall defect, and has an outer periphery. The prosthesis further includes a second structure having a reinforced central region and an outer peripheral edge, a reinforcing element positioned between the first and second structures, and having an outer periphery and a stiffness greater than that of the first and second structures, and at least one pulling element coupled to the reinforced central region of the second structure. The second structure is coupled to the first structure substantially only at their respective peripheries.

Abstract: An implantable prosthesis for repairing or reinforcing a tissue or muscle wall defect including a first composite structure including at least one layer of a non-absorbable material, wherein the first composite structure has a central portion sized and shaped to cover at least a portion of the tissue or muscle wall defect, and has an outer periphery. The prosthesis further includes a second structure having a reinforced central region and an outer peripheral edge, a reinforcing element positioned between the first and second structures, and having an outer periphery and a stiffness greater than that of the first and second structures, and at least one pulling element coupled to the reinforced central region of the second structure. The second structure is coupled to the first structure substantially only at their respective peripheries.