Abstract: The devices disclosed herein are composite implantable devices having a gradient of one or more of the following: materials, macroarchitecture, microarchitecture, or mechanical properties, which can be used to select or promote attachment of specific cell types on and in the devices prior to and/or after implantation. In preferred embodiments, the implants include complex three-dimensional structure, including curved regions and saddle-shaped areas. In various embodiments, the gradient forms a transition zone in the device from a region composed of materials or having properties best suited for one type of tissue to a region composed of materials or having properties suited for a different type of tissue.

Abstract: A novel biomedical material, which is characterized by coating a genetically engineered CBD-RGD peptide layer on the surface of a biomedical material consisting of PU to improve the attachment of tissue cells, such as fibroblasts, epithelial cells and endothelial cells. A modified artificial vessel is also disclosed, wherein the adherence of endothelial cells is enhanced by coating a genetically engineered CBD-RGD containing peptide layer on the inner surface of the artificial vessels pre-modified by cross-linked gelatin, and the adhering capacity and activation of platelets is reduced.

Abstract: A neuro decompression device is disclosed that significantly reduces fibroplasia proximate to nerve tissue. The device utilizes particular surface topographies to disrupt scar tissue formation around nerves, and which may include one or more drugs to influence tissue growth.

Abstract: The present invention is generally directed to a method for the production of tissue implants and prosthetics, including but not limited to orthopedic implants and prosthetics which have a controlled and directional gradient of porosity moving through all or one or more portions of the implant, as well as the implants produced by such a method. The non-uniform porosity gradient may be linear or more complex, and is preferably produced to have a continuous gradient within the desired regions. The desired effect is to create an implant which more closely mimics the natural structure of bone, and which improves the quality of the bone growth that occurs within the implant.

Abstract: Textured surface having micro recesses such that the outer surface overhangs the micro recesses. Embodiments of the textured surface include sharp edges for promoting bone deposition and growth within the micro recesses, protrusions of varying depth from the surface that include overhangs, and micro recesses that are at least partially defined by complex ellipsoids.

Abstract: A method of tissue grafting. Tissue elements are obtained from at least one human body and are enclosed within a retaining structure. The tissue elements with the retaining structure are shaped to form a grafting material having a predetermined configuration. The grafting material is then implanted into a patient.

Abstract: A prosthesis for implanting into a bone having a cavity is disclosed. The prosthesis comprises a body and a stem. A first coating including a bone ingrowth promoting material that promotes ingrowth of bone onto the stem and a bioabsorbable material that delays the ingrowth of bone onto the stem is disposed on a proximal portion of the stem outer surface. A second coating including the bone ingrowth promoting material and the bioabsorbable material is disposed on a distal portion of the stem outer surface. The ratio of bone ingrowth promoting material to bioabsorbable material in the first coating is greater than the ratio of bone ingrowth promoting material to bioabsorbable material in the second coating whereby the affixation of the bone to the proximal zone of the stem is faster and stronger over time than the affixation of the bone to the distal zone of the stem.

Abstract: A flat implant for use in surgery is described. The implant includes a flexible fabric comprising two sides and having on one side a substantially closed surface and on the other side a three-dimensional microstructure permitting a growing in of cells. The implant can be more particularly used for the treatment of wall defects in body cavities, such as abdominal wall defects.

Abstract: A prosthetic implant system connected to the tissue of a living organism. The system contains a first device for measuring the mechanical strain in the implant in an area thereof which is not exposed to tissue regrowth, a second device for measuring the mechanical strain in the implant in an area thereof which is exposed to tissue regrowth, a device for continuously determining the stress/strain relationship of said implant, and a device for treating said tissue.

Abstract: The invention relates to a process for producing an implant, with the implant possessing a textured foreign structure. A porous protein matrix is at least partially anchored in the textured foreign structure, with the porous protein matrix possessing a directional pore structure.

Abstract: The present invention provides a biointerface membrane for use with an implantable device that interferes with the formation of a barrier cell layer including; a first domain distal to the implantable device wherein the first domain supports tissue attachment and interferes with barrier cell layer formation and a second domain proximal to the implantable device wherein the second domain is resistant to cellular attachment and is impermeable to cells. In addition, the present invention provides sensors including the biointerface membrane, implantable devices including these sensors or biointerface membranes, and methods of monitoring glucose levels in a host utilizing the analyte detection implantable device of the invention. Other implantable devices which include the biointerface membrane of the present invention, such as devices for cell transplantation, drug delivery devices, and electrical signal delivery or measuring devices are also provided.

Abstract: A composition or device suitable for orthopedic or dental implantation to bone, characterized by tartrate-resistant acid phosphatase (TRAP) adsorbed to a porous hydroxyapatite substratum.

Abstract: The invention provides tissue graft compositions comprising collagen-based extracellular matrices derived from renal capsules of warm-blooded vertebrates. The invention further provides a process of harvesting and purifying a renal capsule to provide an extracellular matrix material having beneficial use as a tissue graft and/or cell growth material.

Abstract: A prosthetic implant having a tissue scaffold and a fixation device with a scaffold support and an anchoring post. The anchoring post extends from a surface of the scaffold support at a selected angle with the scaffold support embedded within the scaffold. The scaffold has a porous ceramic phase and a porous polymer phase. The polymer is foamed while in solution that is infused in the pores of the ceramic to create a interphase junction of interlocked porous materials and embedding the scaffold support portion of the fixation device. The preferred method for foaming is by lyophilization. The scaffold may be infused or coated with a variety of bioactive materials to induce ingrowth or to release a medicament. The mutilayered porous scaffold can mimic the morphology of an injured tissue junction with a gradient morphology and cell composition.

Abstract: Methods and apparatus for modifying membranous tissue, growing cells on modified membranous tissue, and for transplantation of modified tissues and modified tissues with attached cells are provided. In particular, the invention provides methods and apparatus for modifying membranous tissue such as lens capsule tissue and inner limiting membrane tissue, for growing cells such as iris pigment epithelial (IPE) cells and retinal pigment epithelial (RPE) cells on modified membranous tissue, and for modifying membranous tissue and growing cells on biodegradable polymer substrates. A method of modifying membranous tissues comprises depositing micropatterns of biomolecules onto membranous tissue with a contacting surface such as a stamp; other methods include mechanical ablation, photoablation, ion beam ablation, and modification of membranous tissues via the action of proteolytic enzymes.

Abstract: The present invention relates to tissue scaffold implant devices useful in the repair and/or regeneration of diseased and/or damaged musculoskeletal tissue and that include a foam tissue scaffold component fixedly attached to a scaffold fixation component via partial encapsulation of the fixation component by the foam scaffold component, and to methods of making such tissue scaffold implant devices.

Abstract: A multilayer ingrowth matrix is constructed within well-defined porosity of a prosthetic material. The matrix consists of either proteinaceous or synthetic layers or gradients, or a combination of proteinaceous and synthetic layers or gradients. Each layer within the matrix is designed to achieve a specific function, such as facilitation of ingrowth of a particular cell type or release of a particular growth factor. The well-defined porosity is in the form of either helically oriented, interconnected transmural ingrowth channels, or a porous wall structure containing uniformly shaped pores (i.e. voids) in a very narrow size range, or a combination of channels and pores. This invention allows for uninterrupted ingrowth of connective tissue into walls of a synthetic graft prosthesis made from the prosthetic material. Furthermore, this invention can produce small diameter prostheses having an internal diameter of 6 mm or less.

Abstract: Bone augmentation in a mammalian body to enhance the mechanical strength of a prosthesis is provided by reinforcement of bone in the region surrounding the implant device. A number of fibrillar wires are formed on the prosthetic implant device. Formation of the fibrillar wires comprises gauging the implant device so that the fibrillar wires are formed by peeling them from the implant device. Alternatively, formation of the fibrillar wires may comprise forming a mesh of fibrillar wires having a woolly structure, forming the mesh around the prosthetic implant device, and attaching a number of the fibrillar wires to the prosthetic implant device. A coating is formed on the fibrillar wires and an associated prosthetic implant device. The coating comprises bone morphogenetic proteins along with osteoinductive factors and osteoconductive factors that function as nutrients, anti-microbial and anti-inflammatory agents, and blood-clotting factors.

Abstract: Composite devices for tissue engineering are provided having a gradient of one or more of the following: materials, macroarchitecture, microarchitecture, or mechanical properties, which can be used to select or promote attachment of specific cell types on and in the devices prior to and/or after implantation. In various embodiments, the gradient forms a transition zone in the device from a region composed of materials or having properties best suited for one type of tissue to a region composed of materials or having properties suited for a different type of tissue. The devices are made in a continuous process that imparts structural integrity as well as a unique gradient of materials in the architecture. The gradient may relate to the materials, the macroarchitecture, the microarchitecture, the mechanical properties of the device, or several of these together. The devices disclosed herein typically are made using solid free form processes, especially three-dimensional printing process (3DP™).

Abstract: A device for surgically repairing and reinforcing a hernia includes a hernia prosthesis having a substantially planar base portion and an overlay portion, each formed from a biocompatible material. The overlay portion is peripherally attached to the base portion to define a pocket to receive a surgical instrument or a surgeon's finger for placing the prosthesis within the human body. The pocket may be formed with releasable stitching to enable it to be flattened or removed after placement and may contain a resilient member that urges the prosthesis into a flat configuration.

Abstract: The present invention provides a hard tissue scaffold comprising a resorbable ceramic. The scaffold is formed by first creating unfired (green) bioresorbable ceramic fibers via the viscous suspension spinning process (VSSP). Then, using common textile techniques, a structure in which the size and distribution of interconnected pores are controlled, is created. Heat treating the structure to remove the organic phase and sintering the ceramic yields a hard tissue scaffold.

Abstract: A flat implant for use in surgery is described. The implant includes a flexible fabric comprising two sides and having on one side a substantially closed surface and on the other side a three-dimensional microstructure permitting a growing in of cells. The implant can be more particularly used for the treatment of wall defects in body cavities, such as abdominal wall defects.

Abstract: A method for tissue augmentation in a mammal is provided comprising injecting a polymer at a tissue site in need of augmentation and having a tissue temperature, the polymer comprising repeating peptide monomeric units selected from the group consisting of nonapeptide, pentapeptide and tetrapeptide monomeric units, wherein the monomeric units form a series of &bgr;-turns separated by dynamic bridging segments suspended between the &bgr;-turns, wherein the polymer has an inverse temperature transition Tt less than the tissue temperature, and wherein the polymer is injected as a water solution at coacervate concentration in the substantial absence of additional water. A kit containing the injectable bioelastic polymer and a syringe is also provided.

Abstract: Disclosed and claimed are compositions, devices, methods and kits that are useful in surgical procedures, specifically to induce adhesions for the purposes of stabilizing implants, closing apertures, and otherwise promoting the adhesion of implants and anatomical structures to one another. The invention pertains to a composition containing specific particulate components, wherein the particulates promote an inflammatory reaction that results in the formation of an adhesion.

Abstract: Coated implantable prosthetic devices are disclosed. The device is a prosthetic having a gold layer on the surface to which bioactive molecules are attached through a gold-sulfhydryl bond. The devices are easy and convenient to prepare. Gold coated implantable devices are also disclosed herein. The gold coated implantable device is a prosthetic device formed of a porous non-fabric material having a surface with projections and indentations and the gold layer on the surface of the porous non-fabric material forms a uniform layer across the material such that the gold layer also forms projections and indentations.

Abstract: An interbody fusion device for engagement between vertebrae includes a pair of lateral spacers for spacing the vertebrae, and a connecting member adapted to couple together the lateral spacers when inserted between the vertebrae. The connecting member, individual lateral spacers, or the entire spinal spacer can be made of bone in order to promote fusion of the vertebrae. The modular construction permits use of bone segments otherwise unsuitable due to size or strength in stable fusion devices.

Abstract: There are numerous medical situations involving deficiencies of living bone or periodontal tissue and where increase of living bone or periodontal tissue mass is desired. Methods are described wherein a configured, shell-like device that is capable of being penetrated by living cells and tissues, is implanted into the body of a mammal in such a way as to establish a space, the space being at least partly, bounded by the device. The configuration of the device is such that the configuration of the established space is essentially the same as the configuration of living bone or periodontal tissue that is desired for treatment of the tissue deficiency. At least one protein from the Transforming Growth Factor-Beta Superfamily of proteins is placed within the established space for the purpose of stimulating the growth of living bone or periodontal tissue within the established space. A kit for the generation of living bone or periodontal tissue, comprised of the components mentioned above, is also disclosed.

Abstract: The present invention is generally directed to a method for the production of tissue implants and prosthetics, including but not limited to orthopedic implants and prosthetics which have a controlled and directional gradient of porosity moving through all or one or more portions of the implant, as well as the implants produced by such a method. The non-uniform porosity gradient may be linear or more complex, and is preferably produced to have a continuous gradient within the desired regions. The desired effect is to create an implant which more closely mimics the natural structure of bone, and which improves the quality of the bone growth that occurs within the implant.

Abstract: A prosthetic implant for obturating an anatomical duct, cavity or orifice, has a porous textile element obtained from a prosthetic fabric, having a flat and nongathered up configuration in the shape of a patch with a continuous outer edge or periphery. The implant has at least two radial elements extending and distributed around a central zone free from any radial element. The radial element centripetally stresses the remaining periphery of the textile element. A peripheral zone having radial elements is comprised of at least two superimposed panels of prosthetic fabric. The radial elements are in the shape of textile strips and consist of a multiplicity of stitches linking the two panels with at least one thread.

Abstract: Cartilage tissue and implants comprising tissue are produced in vitro starting from cells having the ability to form an extracellular cartilage matrix. Such cells are brought into a cell space (1) and are left in this cell space for producing an extracellular cartilage matrix. The cells are brought into the cell space to have a cell density of ca. 5×107 to 109 cells per cm3 of cell space. The cell space (1) is at least partly separated from a culture medium space (2) surrounding the cell space by means of a semi-permeable wall (3) or by an open-pore wall acting as convection barrier. The open-pore wall can be designed as a plate (7) made of a bone substitute material and constituting the bottom of the cell space (1). The cells settle on such a plate (7) and the cartilage tissue growing in the cell space (1).

Abstract: A method for repairing defects and reconstructing urothelial structures in vivo has been developed using a fibrous, open synthetic, biodegradable polymeric matrix which is configured to provide the desired corrective structure. The matrix is shaped to correct the defect, then implanted surgically to form a scaffolding for the patient's own cells to grow onto and into. The implantation of the matrix initiates an inflammatory reaction, resulting in urothelial cells, endothelial cells and mesenchymal cells, to migrate into the matrix. The polymer forming the matrix is selected to be biocompatible and degradable in a controlled manner over a period of one to six months, in the preferred embodiment. A preferred material is a poly(lactic acid-glycolic acid) in a fibrous form, such as a woven or non-woven mesh. Examples demonstrate the repair of defects in bladder in rabbits.

Abstract: A surgical prosthesis for repairing a hernia in a sturdy tension-free manner. The prosthesis includes a layer of adhesion resistant material and a first layer of tissue ingrowth receptive mesh material affixed to the layer of adhesion resistant material. A second layer of tissue ingrowth receptive mesh material is positioned adjacent the first layer of tissue ingrowth receptive mesh material and a connecting thread is interwoven between the midsections of the layers for forming a midsectional seam fastening together the three layers. The prosthesis is implanted in the hernial area of the patient in such a manner as to duplicate the structure of the original unherniated fascial tissue. The adhesion resistant layer faces inwardly to prevent adhesion of internal body viscera to the prosthesis.

Abstract: Acellular matrix grafts are provided with are isolated from natural sources and consist essentially of a collagen and elastin matrix which is devoid of cellular components. The grafts are useful scaffolds which promote the regeneration of muscle tissue and aid in restoring muscle function. Due to their acellular nature, the grafts lack antigenicity. As a result, the acellular matrix grafts can be isolated from autographic, allographic or xenographic tissues.

Abstract: A hernia repair prosthetic element includes: a central portion which covers a hernia opening within a patient; plural support portions integrally connected about a periphery of the central portion for securing the central portion in covering relation to the hernia opening; the prosthetic element, including the central and support portions, being a substantially planar member formed of flexible mesh material; the support portions being foldable relative to the central portion so that the prosthetic element can be selectively manipulated between folded and unfolded shapes; the support portions being adapted to securely engage various components of the patient's body surrounding the hernia opening; and openings are formed through the central portion for passage of fluid therethrough. The prosthetic element has only two basic shapes, one for use in relation to all groin hernias and one for use in relation to all abdominal hernias.

Abstract: Protective devices, to protect a body part having a bony portion with a soft tissue layer between the bony portion and an outer skin layer, have an inner surface which conforms to the body part to be protected and are applied to the body part to reduce pressure exhibited at the interface between the bony portion and the soft tissue layer, across the soft tissue and outer skin layers and at the interface between the outer skin layer and a support surface. The protective devices may be made of any material suitable for distributing the weight of the body part over an extended area and volume and may include a mushy material, a hard shell, a hydro absorptive material, and a wound dressing with medication. The body part to be protected includes at least one of the heel, trochanter, knee, sacrum, coccyx, ischium, scapula, elbow, ankle, buttocks and occiput; The protective devices may be secured to the body part directly or via a garment or any other suitable securing means.

Abstract: A method of promoting regeneration of surface cartilage of a joint includes the steps of forming punctures in a subchondral plate of an area of the joint to be treated, covering the puncture and the area to be treated with a chondrocyte-free patch made of a sheet of collagen membrane material without adding chondrocytes to the area to be treated, fixing the patch over the area to be treated, and allowing the area to be treated to regenerate cartilage without adding chondrocytes to the area to be treated.

Abstract: The implant holder comprises a screen (21) comprising on one side a tissue-compatible fibre material (25) to which the body cells grow and on the other side a smooth contact surface (23) for the implant (10). A holding fixture (26) retains the implant (10) to the screen (21). The implant holder prevents the body tissue from directly growing to the implant, which would make exchange of the implant (10) more difficult. To exchange the implant the skin (16) of the patient is cut open and the holding fixture (26) is opened. The implant holder remains in the body while the implant (10) is exchanged.

Abstract: An implantable prosthesis for use in abdominal and thoracic surgery, in the form of a tini sheet. One of the sheet's surfaces is of a linear continuous, non-porous structure and is capable of sustaining the growth of mesothelial cells. This impedes adhesion fomation and fistulization of the viscera On the sheet's other surface, the material is discontinuous in structure with physical voids that stimulate and modulate fibroblast proliferation and collagen deposition, achieving the repair of the original defect by connective tissue. This side of the prosthesis is able to fuilly integrate within host tissue, Due to its lack of excess material, the risk of microorganisms settling on this side and of chronic infection is reduced.

Abstract: A method and apparatus for treating snoring include selecting an implant formed form a sheet of flexible, bio-compatible material. The sheet has a longitudinal length between a proximal edge and a distal edge, a transverse width and a thickness between upper and lower surfaces. The material is sized to be inserted into the soft palate with the longitudinal length extending aligned with an anterior-posterior axis of the soft palate and with the thickness contained within a thickness of the soft palate. The material has a plurality of spaces for accepting tissue growth from the soft palate into the spaces. The implant is inserted into the soft palate with the longitudinal length extending aligned with an anterior-posterior axis of the soft palate and with the thickness contained within the thickness of the soft palate.

Abstract: A prosthetic device formed from a polymer which, when contacted with a calcium salt, calcium is deposited on or in the polymer. The polymer includes a soft component and a hard component. The device has bone-bonding properties. The soft component provides for the deposition of calcium on or in the soft component and preferably is a polyalkylene glycol, and the hard component preferably is a polyester. A preferred material is a polyethylene glycol/polybutylene terephthalate copolymer.

Abstract: There are numerous medical situations involving deficiencies of living tissue and where increase of living tissue mass is desired. Methods are described wherein a configured, shell-like device that is capable of being penetrated by living cells and tissues, is implanted into the body of a mammal in such a way as to establish a space, the space being at least partly, bounded by the device. The configuration of the device is such that the configuration of the established space is essentially the same as the configuration of living tissue that is desired for treatment of the tissue deficiency. At least one tissue stimulating molecular substance is placed within the established space for the purpose of stimulating the growth of desired living tissue within the established space. A kit for the generation of desired living tissue, comprised of the components mentioned above, is also disclosed.

Abstract: The invention relates to a porous composite which comprises particles made from a bioactive material, the particles being sintered together to form a porous composite. It is characteristic that the particles have one or more recesses or throughgoing holes, or that the particles provided with an unbroken surface layer are hollow.

Abstract: This invention relates to a biomaterial useful in bone repair and replacement, and to implants for cranofacial, orthopaedic, and especially dental applications. The implants have a unique geometric configuration, their surfaces defining concavities having a shape and dimensions which induce or enhance the rate and/or amount of bone growth at the implant site. The biomaterial preferably has a specific porous configuration and the implant may be at least coated with such a biomaterial of hydroxyapatite, for example.

Abstract: A prosthetic repair fabric including a sheet of tissue infiltratable fabric and a second sheet, also preferably including tissue infiltratable fabric, which is united with the first sheet. The second sheet is fused to an adhesion resistant barrier, forming a laminate composite prosthesis without degrading the mechanical properties or tissue ingrowith capability of the first sheet.

Abstract: The invention provides an article of manufacture comprising a substantially non-immunogenic soft tissue xenograft for implantation into humans. The invention further provides methods for preparing a soft tissue xenograft by removing at least a portion of a soft tissue from a non-human animal to provide a xenograft; washing the xenograft in saline and alcohol; subjecting the xenograft to cellular disruption treatment; and digesting the xenograft with a proteoglycan-depleting factor and/or glycosidase and optionally following with a capping treatment. The invention also provides an article of manufacture produced by the above-identified method of the invention. The invention further provides a soft tissue xenograft for implantation into a human including a portion of a soft tissue from a non-human animal, wherein the portion has extracellular components and substantially only dead cells. The extracellular components have reduced proteoglycan molecules.

Abstract: A medical product is made available having a melt-blown fibrous structure of biocompatible polymer material in the form of a three-dimensional shaped article with a porous structure aiding cell growth. It can be used in human and/or veterinary medicine, as an implant or extracorporeal organ replacement.

Abstract: Composite prosthesis, comprising a non-absorbable prosthetic fabric and at least one film made of a material which is absorbable in vivo, combined with one surface of the prosthetic fabric. In combination, the prosthetic fabric has a three-dimensional structure separating its two surfaces, at least one of which is open to all post-surgical cell colonization, and the film of absorbable material is linked at least superficially to the other surface of said fabric.

Abstract: An anatomically specific, bioresorbable, implant device for facilitating the healing of voids in bone, cartilage and soft tissue is disclosed. A preferred embodiment of using the implant device for facilitating the healing of a human joint lesion includes a cartilage region invested with an alginate microstructure joined with a subchondral bone region invested with a hyaluronan microstructure. The alginate selectively dispersed in the cartilage region enhances the environment for chondrocytes to grow articular cartilage. The hyaluronan selectively dispersed in the subchondral bone region enhances the environment for mesenchymal cells which migrate into that region's macrostructure and which differentiate into osteoblasts. The microstructures can be invested at varying concentrations in the regions. A hydrophobic barrier, strategically positioned within the subchondral bone region macrostructure, shields the chondrocytes from the oxygenated blood in subchondral cancellous bone.

Abstract: An infection-blocking dental implant in which a threaded portion which contacts bone is roughened except for up to three threads which may be exposed by bone recession after implantation, which have a smooth surface. Preferably, the implant is of titanium or titanium alloy and the threaded portion is roughened by a two-step acid treatment.

Abstract: An implantable prosthesis having porous textured surface regions and methods for making the same provide improved prostheses and prosthesis manufacturing methods. The implantable prostheses contain one more bead preforms that are secured to the metallic prosthesis components during the casting process to form porous textured surface regions in desired areas of the prostheses.