Abstract: The present invention provides nano-porous fibers and protein membrane compositions. In certain embodiments, continuous fiber compositions are provided having nanometer sized diameters and surface pores. In another embodiment, a protein membrane composition is provided comprising a protein; and a polymer, wherein the protein and the polymer are electrospun to form a protein membrane composition. In certain instance, the protein is covalently bound to the fiber.

Abstract: In surgery, mesh-shaped implants, so-called meshes, are used for supporting damaged body parts that are to be closed. These usually consist of multifilament polymers, more specifically of polyester and polypropylene. Post-surgery complications are frequent, though. The implant also becomes encapsulated as a foreign body within the tissue.

Abstract: A surgical implant is made from biocompatible fiber material as a woven textile fabric, in particular in the form of a vascular prosthesis, the woven fabric being so configured that its permeability to blood is so low that the blood impregnates the textile fabric upon implantation and seals it off by coagulating, but does not flow through it.

Abstract: An implantable prosthesis is provided for repairing or augmenting anatomical weaknesses or defects, and is particularly suitable for the repair of soft tissue and muscle wall openings. The prosthesis is configured to promote enhanced tissue ingrowth thereto, while limiting the incidence of post-operative adhesions between the fabric and tissue or organs. The prosthesis may include a layer of fabric that is constructed and arranged to allow tissue ingrowth and is susceptible to the formation of adhesions for tissue and organs. One or more barriers may be provided on selected portions of the fabric to inhibit the formation of adhesions with tissues and organs. The prosthesis may have an opening that is adapted to receive the esophagus or other tube-like structure, or other projection, that passes through an opening in or projects from a tissue, muscle or organ wall requiring repair and/or augmentation. The prosthesis may be configured for use in hiatal hernia repair and/or treatment of GERD.

Abstract: A method and apparatus relating to a biocompatible soft tissue implant is disclosed. The implant, in the form of a prosthesis, is constructed of a knitted pile mesh material arranged into either a 3-dimensional structure or a planar shape or structure. The material or fabric includes a plurality of filament extensions projecting outwardly therefrom. The filament extensions can be radially projecting looping filaments from one or more rows of the knitted pile mesh material. The combination of the filament extensions with the 3-dimensional structure results in the biocompatible implant having a structural resistance to hinder anticipated crushing forces applied to the implant, and also provide a suitable 3-dimensional structure for promoting rapid tissue in-growth to anchor such implant without migration and strengthen the repaired tissue area.

Abstract: An implantable prosthesis comprised of a solid elastomer made from a synthetic organic polymer that is biocompatible, compliant, and has water content greater than 5%. The solid construction prevents leaks and ruptures that are prevalent in other implants. The implant has the look, fit and feel of human tissue from various parts of the body.

Abstract: The present invention relates to an intermediate composite part (1) designed for forming a composite reinforcement prosthesis and comprising:

Abstract: The present invention relates to a medicinal product with a textile component such as a wound compress having a surface containing a multiplicity of openings arranged in at least two hole patterns. The diameter of one opening of one hole pattern deviates from the diameter of an opening of another hole pattern by about at least a factor of 5. Better wound healing is achieved by adapting the structural and mechanical characteristics of the medicinal product to the characteristics of the target tissue.

Abstract: A textile prosthesis comprising a unitary body of predetermined shape having structural integrity, the body including at least one anchorage body portion for attachment to an anatomical body part, the body being composed of a combination of binding yarns and tensile load bearing filaments, the binding yarns being located at least in the or in each of said anchorage body portions and being interconnected to one another by sewn stitches, the tensile load bearing filaments being located inbetween said stitches so as to be constrained to extend through said unitary body along predetermined pathways extending in one or more predetermined directions so as to render the body resistance to stretch when a tensile load is applied in said one or more predetermined directions.

Abstract: The present invention provides devices and methods for treating biological tissue. The treatment comprise implanting a scaffold implant device into in combination with a therapeutic material such as cells, tissue or cell components. The scaffold device serves to hold the therapeutic material at the treatment site, protecting it from being squeezed out by surrounding tissue. Additionally the scaffold device is believed to trigger an injury response that leads to angiogenesis in the tissue, which provides blood flow and nutrients to the associated therapeutic material to sustain it for a therapeutically effective amount of time. The devices may also be implanted at a tissue site already treated with a therapeutic material to initiate angiogenesis at the treatment site to sustain the material. The devices and methods also may be used to treat tumors with a necrosis factor.

Abstract: Bioprosthetic devices for soft tissue attachment, reinforcement, or construction are provided. The devices comprise a sheet of naturally occurring extracellular matrix and a sheet of synthetic mesh coupled to the naturally occurring extracellular matrix portion.

Abstract: A prosthetic knit for medical or surgical use which has a structure made of monofilament and/or multifilament yarn which is biocompatible and optionally partially bioabsorbable.

Abstract: Tissue engineering devices with enhanced cell adhesion, cell proliferation and directional growth are provided which are prepared from nonwoven nanofibril matrices.

Abstract: A prosthesis is provided for the surgical treatment of hernias. The prosthesis includes two parts, that is, a synthetic non-resorbent mesh and a ring fixed at the peripheral edge of the synthetic mesh. The ring, which is made of a resorbent material, is of a flexibility that permits it to bend, then resume its initial shape to give the mesh a memory of its initial shape. The ring has an interruption intended to be positioned over the femoral veins.

Abstract: A universal, surgical prosthesis for hernia repair is provided in the form of a foldable sheet. The prosthesis includes a barrier layer formed of a material adapted to prevent biological adherence thereto, such as polytetrafluoroethylene, and a second surface layer formed of a material adapted to promote biological tissue adherence thereto, such as polypropylene. The second surface may be formed of a series of spaced projections. The prosthesis is adapted to be manipulated into an operative position to exhibit an appropriate exterior when in the operative position. In this manner, the universal, surgical prosthesis can be utilized for a wide range of surgical procedures.

Abstract: A soft tissue implant material is formed from biologically-compatible polymeric particles. The particles may have a diameter of up to about 500 microns and intraparticulate pores sized for ingrowth of soft tissue. The particles may have an inner core of a first biologically-compatible polymeric material and an outer layer generally surrounding the inner core, with the outer layer comprised of a second biologically-compatible polymeric material being hydrophilic and having a composition different from the composition of the first polymeric material. The material may be utilized with collagen or other matrix materials. This material may be used in a method of reforming soft tissues by implanting the material within soft body tissues to modify soft tissue defects such as wrinkles or oral gingival tissue defects and reshape soft tissue, e.g., for urinary bladder inconvenience.

Abstract: A surgical implant having a datum surface for engaging tissue. Embodiments of the surgical implant include a recess in an original datum surface having a sharp undercut ovoid configuration and a multiplicity of recesses that are interconnected.

Abstract: A process for creating surface microporosity on a titanium (or other metal) medical device includes creating a surface oxide layer on the device; placing the device, which is connected to a negative terminal of an electrical power supply, into a calcium chloride bath; connecting the positive terminal of the power supply to an anode immersed in or containing calcium chloride thereby forming an electrolytic cell; passing current through the cell; removing the device from the bath; and cooling and rinsing the device to remove any surface salt. If necessary, the device is etched to remove metal oxide which may have formed during the cooling process. The resulting device has a microporous surface structure. Alternatively, only a designated surface portion of a medical device is made microporous, either by applying a non-oxidizing mask, removing a portion of the oxide layer, or subtracting a portion of a microporous surface.

Abstract: The surgical device has a non-bioabsorbable layer, generally in the form of a mesh for strength and ease of handling, and a bioabsorbable layer including urea derivatives of hyaluronic acid or carboxymethyl cellulose with the two layers bound by an adhesive. The surgical device may be used for tissue repair such as to seal an opening in a tissue of the body of a patient. The non-bioabsorbable layer integrates within the tissue, while the bioabsorbable layer prevent adhesion of the device to other tissues before it is absorbed by the body. Methods of manufacturing the device are also disclosed.

Abstract: In one aspect the present invention provides indented structures that each include (a) a body defining a plurality of indentations, substantially all of the plurality of indentations including a surface layer including a biologically active substance; and (b) a body surface, wherein each of the plurality of indentations opens onto the body surface through a plurality of openings, and wherein the biologically active substance is not substantially present on the body surface. Examples of structures of the present invention include medical devices, such as medical devices that are completely or partially implantable into a living body. The surface layer of the indentations (or at least some of the indentations) of the medical devices of the invention may include biologically active molecules, such as proteins, that promote the growth of cells into and/or within the indentations, thereby promoting the acceptance of the implanted device by the living body.

Abstract: A porous three dimensional structure for implantation in a host animal capable of producing an inflammatory foreign body response. The structure includes first and second layers spaced by a plurality of posts having a predetermined length connecting the first and second layers. Each of the layers has a plurality of openings of a predetermined size permitting fluids and inflammatory cells of the animal to pass through the openings and migrate into an interior volume defined by the first and second layers. The size of the openings and length of the posts promote a non-flattened morphology of the cells. The structure promotes vascularization adjacent to the structure when implanted into the animal.

Abstract: A flexible prosthesis, in particular for curing hernias by colioscopy, the prosthesis including at least one anchor, device made of shape memory material designed to be deformed merely under temperature control from a storage position into a fixing position in which the anchor device interferes with the surrounding tissue.

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: The present invention relates to a prosthetic mesh system adapted for implantation in a body. More particularly, the mesh system includes a biocompatible mesh layer. The mesh layer is flexible such that the mesh layer has a generally flat shape when it is in a first condition and a generally collapsed shape when it is in a second condition. The mesh layer has at least one ridge formed integrally therewith and projecting therefrom in a direction substantially perpendicular to the mesh layer when the mesh layer is in the first condition. The ridge is sized and shaped so as to facilitate the movement of the mesh layer from its collapsed shape to its flat shape.

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: An implantable substantially planar bioabsorbable article for the separation and regeneration of tissue at a tissue defect site includes first surface of the article, which may be circular or elliptical, that is provided with a soft tissue side intended for direction towards soft or subcutaneous tissue and having a microtextured surface optimized for promotion of ingrowth of soft tissue. An opposite side of the article comprises a different microgrooved surface, optionally including osteoconductive chemical properties, and physically oriented against or within the bone defect site toward and against the center of the defect into which any graft material placed. The membrane is flexible and of sufficient density to accommodate sutures or is circumfentially provided with perforations to hold sutures.

Abstract: A method and apparatus relating to a biocompatible soft tissue implant is disclosed. The implant, in the form of a prosthesis, is constructed of a knitted pile mesh material arranged into either a 3-dimensional structure or a planar shape or structure. The material or fabric includes a plurality of filament extensions projecting outwardly therefrom. The filament extensions can be radially projecting looping filaments from one or more rows of the knitted pile mesh material. The combination of the filament extensions with the 3-dimensional structure results in the biocompatible implant having a structural resistance to hinder anticipated crushing forces applied to the implant, and also provide a suitable 3-dimensional structure for promoting rapid tissue in-growth to anchor such implant without migration and strengthen the repaired tissue area.

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: Leak and tear resistant grafts for repair and replacement of living animal tissue are disclosed. The grafts, which may be flat or tubular, are formed of interlaced filamentary members and have reinforced attachment regions defined by interlaced filamentary members of higher tensile strength. Higher strength is provided by use of high strength material, increased denier or number of plies of the filamentary members. High strength members inhibit propagation of tears which occur in the graft when the attachment region is pierced by sutures or staples. Filamentary members formed of textured, elastic or heat shrinkable yarns interlaced in the graft inhibit leakage.

Abstract: An areal implant has a mesh-like basic structure (30) which is provided with a reinforced zone (32) in a central area. Radial reinforcing elements (34, 36) can extend from the reinforced zone (32) towards the peripheral edge (31) of the basic structure (30).

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: Methods for reproducing a 3D object surface are provided. A preferred method according to this invention includes (1) identifying a real object surface, (2) acquiring at least a 3D data set with a 3D surface imaging device, (3) acquiring at least a 2D data set using a 2D surface imaging device with a surface resolution of at least about 0.1 mm2, (4) synthesizing a 3D composite data set by orienting a first virtual image of the first data set and a second virtual image of the second data set to form a composite virtual image that corresponds to the composite data set, and (5) making a reproduction of the object surface with the composite data set. Orientation of the virtual images is relative to each other and without substantial loss of surface resolution.

Abstract: A biomaterial is provided which is suitable for use in surgery in a human patient. It comprises a coherent layer of non-human collagenous tissue which has been subjected to glutaraldehyde tanning so as to comprise cross-linked collagen fibrils, and a reinforcement of synthetic material embedded within the coherent layer. The synthetic material has structure features for promoting the embedding, the synthetic material having on average in situ more than 50 of the features per square centimeter. Improvements are also provided in a method of producing biomaterials by allowing collagenous tissue growth on mesh structures covering support surfaces implanted into host animals. In one aspect a tubular synthetic fiber mesh structure fits loosely over a support rod or tube, and in the other aspect a sheet support is used and the tissue growing around the sheet support is adapted to form a pocket, pouch or envelope of collagenous material.

Abstract: A three dimensional facial space-filling implant adapted for filling space subcutaneously, said space being located primarily at the interface of a soft tissue surface and a bone surface. The article has a length, width and thickness wherein the thickness is oriented substantially orthogonal to first and second substantially opposing surfaces of the article. The thickness varies according to location along the length and width. The first surface is adapted to be substantially in contact with the soft tissue surface when implanted. This first surface is substantially porous having void spaces of size adequate to allow tissue ingrowth into at least a portion of the void spaces. The second surface is adapted to be substantially in contact with the bone surface when implanted and is substantially non-porous to substantially prevent ingrowth of bony tissue into the second surface. The first surface is preferably porous polytetrafluoroethylene and the thickness and second surface are preferably silicone.

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: A soft tissue expander has enhanced performance through use of differential and directional expandability, continuous expansion capability, increased base and dimensional stability, increased soft tissue purchase by virtue of unique surface topography, and results in improved cavity contour after expansion. Expansion means may be provided to expand the implant in a desired direction. In the preferred embodiment, an expander or implant has an exterior surface defining a volume, the exterior surface including a base portion, a first wall and a second wall, wherein the second wall is relatively thinner than the first wall. A fill port, which may be integrally molded into the expander, is included. As the expander is inflated, differential expansion occurs with the relatively thin second wall section expanding more than that of the first wall section. The base may include ribs or other molded-in structures to increase structural integrity.

Abstract: The implant holder comprises a screen (21) comprising on one side a tissue-compatible fiber 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: A method of protecting a spinal area of a patient includes the step of positioning a sheet of collagen membrane material so as to surround at least a portion of a patient's spinal chord. The sheet of collagen membrane preferably includes at least one barrier layer with a smooth face to inhibit cell adhesion and act as a barrier to prevent passage of cells therethrough. When surgery involves placement of s vertebrae replacement material between vertebrae, the collagen membrane material can be positioned so as to surround at least a portion of the vertebrae replacement material.

Abstract: Methods and materials for tissue reconstruction, repair, and/or augmentation are disclosed. The invention provides isolated bladder submucosa seeded with cells for use in tissue reconstruction. The methods of the invention include the use of isolated bladder submucosa seeded with cells for augmentation of bladder and other organs and tissues.