Abstract: A method for manufacturing a multilayered cell sheet characterized in fabricating a vascular bed that constructs a vascular network extending to the surface from a channel for perfusing a medium, the channel being embedded in a gel; and layering a cell sheet onto the vascular bed to construct a vascular network in the cell sheet. This manufacturing method makes it possible to construct a vascular network in the cell sheet and to fabricate a thick multilayered cell sheet in a simple manner by layering cell sheets. Such a thick multilayered cell sheet is useful as an in-vivo tissue substitute in regenerative medicine involving a variety of tissues.

Abstract: A method is provided for preparing a tissue implant for implantation. The method includes treating a pericardium tissue material, which has been harvested from a donor and rendered essentially acellular, with a chlorine dioxide treatment solution; and thereafter treating the pericardium tissue material with an antioxidant solution, which comprises ascorbic acid or a salt thereof.

Abstract: The present disclosure provides a tissue product comprising a tissue sheet. The sheet can be formed from a plurality of tissue matrix fragments.

Abstract: The present disclosure provides tissue fillers. The tissue fillers can include a plurality of tissue particles formed from acellular tissue matrix fragments. The tissue fillers can be used to fill tissue sites, such as voids formed after tissue resection.

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 absorbable and expandable closure member used to occlude or exclude a body lumen or cavity, such as a blood vessel, fallopian tube, duct, aneurysmal sac, etc., comprising a closure member comprising one of more sheets of a biomaterial that are rolled, stacked, or folded to form a multilayer construct of a generally cylindrical configuration for deployment through a delivery system, either as a singularly or part of a multiplicity of closure members. The biomaterial is derived from a source material, such as small intestinal submucosa or another remodelable material (e.g., an extracellular matrix) having properties for stimulating ingrowth of adjacent tissue into the biomaterial deployed within the bodily lumen. The closure member is deployed to the bodily lumen from a delivery sheath, cartridge, and/or over a inner guiding member, such as a wire guide or catheter.

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: A mammalian tissue scaffold and method for making a tissue scaffold including a rigid scaffold body of biocompatible glass fibers bonded together and in special alignment to define open channels within the scaffold to allow fluid flow into and within the scaffold.

Abstract: A transoral gastroesophageal flap valve restoration assembly comprises a pair of tissue grippers. The device comprises an elongated member having a distal end arranged for being fed down an esophagus in communication with a stomach and a tissue shaper carried on the distal end of the longitudinal member. The tissue shaper comprises a first member adjacent the distal end of the elongated member and a second member. The first and second members are hingedly coupled to receive the stomach tissue to be shaped there between. The distal end of the elongated member has one of the tissue grippers that grips esophageal tissue oral of a Z line and the first member of the tissue shaper has the other tissue gripper that grips stomach tissue aboral of the Z line. A tissue fastener maintains the shaped stomach tissue.

Abstract: The present invention includes an anisotropic scaffold, which is prepared by electrospinning a solution of matrix material upon a textile template. The present invention further includes a method of preparing such scaffold. The anisotropic scaffold of the invention finds use in tissue engineering and regenerative medicine.

Abstract: The object of the present invention is to provide a cell induction material, which can be easily formed, has excellent moldability because sintering is unnecessary, and decreases a strain on a human body caused by the exposure of the ends of a titanium wire. A metal mesh made by stockinette stitching with titanium wire is formed into a predetermined shape, and a cell induction material obtained by pressing the formed metal mesh is used. Further, the cell induction material with substantially no ends of the titanium wire that can be sensed through the sense in the vicinity of the surface is used.

Abstract: The present invention relates to a novel bone graft and methods for producing said graft. Said bone graft can be used for surgical, plastic and/or cosmetic bone replacement for a patient in need thereof. The bone graft is made of a scaffold or matrix of sheet material having a 3-dimensional pattern of a continuous network of voids and/or indentations for enhancing new bone growth.

Abstract: A biocompatible tissue implant. The tissue implant may be bioabsorbable, consists of a biocompatible polymeric foam. The tissue implant also includes a biocompatible reinforcement member. The polymeric foam and the reinforcement member are soluble in a lyophilizing solvent. The reinforcement may be annealed and/or coated.

Abstract: Disclosed are bioscaffolds and methods for use in soft tissue repair.

Abstract: Acellular tissue matrix compositions for use in tissue approximation are provided. Also provided are methods for making and using the compositions to approximate tissue.

Abstract: The invention relates to a tissue transplant construct for the reconstruction of a human or animal organ. The tissue transplant construct (5) comprises (a) a membrane composite (1) comprising at least a first biocompatible, collagen-containing membrane (2) and a second biocompatible, collagen-containing membrane (3), wherein the first membrane (2) and the second membrane (3) are adjacent to each other at their flat sides, and wherein the first membrane (2) is of equine or bovine origin and the second membrane (3) is of animal or human origin and the second membrane (3) is of another origin than the first membrane (2); and (b) one or more layers (4) of mucosa tissue cells on one or both outer flat sides of the membrane composite (1).

Abstract: A biocompatible tissue graft includes a first layer of a bioremodelable collageneous material, a second layer of biocompatible synthetic or natural remodelable or substantially remodelable material attached to the first layer; and at least one fiber that is stitched in a reinforcing pattern in the first layer and/or second layer to mitigate tearing and/or improve fixation retention of the graft, and substantially maintain the improved properties while one or more of the layers is remodeling.

Abstract: A reinforcement device for reinforcing tissues having one or more structural deficiencies includes a longitudinally-extending reinforcing layer for treating the structural deficiency, a plurality of spiked naps distributed across the reinforcing layer and projecting therefrom for adhering to the tissue, and a dissolvable matrix layer covering at least a portion of the reinforcing layer and a portion of the plurality of spiked naps. The matrix layer increases the time before the spiked naps substantially adhere to the tissue, thereby allowing the practitioner additional time to position the reinforcement device.

Abstract: A prosthetic valve device, a method for making a valve device, and a method for implanting a valve device into a recipient are provided. The valve device includes at least one flexible member formed at least partially from a woven layer. The woven layer includes a first material and a second material being at least partially woven together. The at least one flexible member is movable between a first position that permits fluid flow in a first direction and a second position that substantially prevents fluid flow in a second direction. The valve has a first, unexpanded configuration and a second, expanded configuration.

Abstract: An occlusion device includes a pair of connected members configured for being situated on opposing sides of a hole in a tissue, wherein the pair of connected members are formed of a material which is bioadsorbable to the tissue. The pair of connected members can include a non-metallic skeleton.

Abstract: A method and apparatus is provided for creating an internal reconstruction tissue graft. Templates may be used to create a multitude of patterns in a variety of tissue reconstruction grafts. An apparatus may be used to create an internal tissue graft for reconstruction through either compression and/or removal of segments. An apparatus may be used, through either compression and or removal of segments of a preformed template made of synthetics and or metal that minors a template that can be used as an internal tissue graft for reconstruction. In a method, such as using software analysis and an apparatus, the physical properties of the tissue graft and its pre- and post-operative properties and appearance may be measured.

Abstract: The invention relates to a biocompatible neural implant for bridging interruptions or defects in nerves resulting from injuries sustained in an accident or following surgery. Inventive neural implants comprise fibers made from natural or synthetic spider silk and allow interrupted nerves to regenerate across defects such that functional nerve conduction is made possible within a short period of time.

Abstract: A substantially flat implant for repositioning a patient's eyebrow that may allow for a gradient lift across the eyebrow. The implant may be geometrically non-symmetrical, and/or may have non-symmetric physical properties. The implant may include a foot portion that extends along a first longitudinal axis and has a length, and a vertical strip portion that extends outwardly from the foot portion along a second longitudinal axis. The strip portion has a length and a width that is smaller than the length of the foot. The second longitudinal axis is offset from the center of the length of the foot portion.

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

Abstract: A tissue modification apparatus includes a first and a second guide, a first and a second set of mounts, and a first and a second actuator. The first guide defines a first axis, and the second guide defines a second axis intersecting the first axis. The mounts of the first set of mounts are movable relative to one another along the first axis, and the mounts of the second set of mounts are movable relative to one another along the second axis. The first actuator and the second actuator are each settable to a stress load, with the first actuator and the second actuator movable, respectively, along the first axis and the second axis to transmit each respective stress load to a piece of tissue mechanically coupled to the first and second set of mounts.

Abstract: An implantable device for facilitating the healing of voids in bone, cartilage and soft tissue is disclosed. A preferred embodiment includes a cartilage region comprising a polyelectrolytic complex joined with a subchondral bone region. The cartilage region, of this embodiment, enhances the environment for chondrocytes to grow articular cartilage; while the subchondral bone region enhances the environment for cells which migrate into that region's macrostructure and which differentiate into osteoblasts. A hydrophobic barrier exists between the regions, of this embodiment. In one embodiment, the polyelectrolytic complex transforms to hydrogel, following the implant procedure.

Abstract: An apparatus includes a component having a shape memory material. The shape memory material has a first shape including a substantially elongate segment. The shape memory material has a second shape including a helix having a first ring and a second ring configured to exert a compressive force on a membrane interleaved between the first ring and the second ring and lying in a plane substantially perpendicular to an axis of the helix, the shape selectable based on an external stimulus.

Abstract: A composite surgical implant that is made of a planar sheet of a thermoplastic resin that includes a top surface (400), a bottom surface (410), and a surgical grade metal mesh (405) contained therein. The implant may be bent by hand, wherein upon the displacement of the implant, the implant will generally maintain the shape to which it has been displaced.

Abstract: Articles, compositions, and methods for growing tissues and organs using bioreactors, including rotating bioreactors, are provided. Synthetic scaffolds for growing artificial tissue and organ transplants are also provided.

Abstract: The invention provides a description of a method and a device suitable for producing a cell suspension spray with living cells, and the produced cell preparation, suitable for grafting to a patient. In contrast to other methods, the spraying is performed through a disposable needle which is inserted into a disposable air tube; which provides a cell distribution avoiding spray nozzles. Small suspension droplets are provided instead of cell nebulization. By using medical grade sterile Luer-lock disposables from medical routine praxis, biocompatibility and easy application is addressed. In applying the method and/or in using the device, cells suitable for grafting to a patient are dispersed in a solution and sprayed with the device for distribution over the recipient graft site.

Abstract: A new structure made of collagen for improving promotion of nerve tissue regeneration, curing and regeneration of a defective part of a soft biological tissue and so on without using laminin or nerve growth factor (NGF), and a member for tissue regeneration including the same. The structure made of collagen has a thin film multilocular formation and is therefore a new structure different from a colloid form, a gel form, and a fiber form. When the new structure made of collagen is used as a member for tissue regeneration, surprisingly, promotion of regeneration, shortening of a treatment period, functional recovery, or the like of bodily tissue such as nerve tissue, subdermal tissue, submucosal tissue, membranous tissue, fat tissue, muscle tissue, skin tissue, and gingival tissue can be improved. When the structure is used in a patient having neuropathic pain, the member has an effect on the disappearance of the pain.

Abstract: The present disclosure relates to a surgical fastener for attaching a prosthesis intended to repair a hernial defect of the abdominal wall, the prosthesis has at least two layers made of a biocompatible flexible material joined together at least one assembly zone, so as to define an internal space delimited by a substantially circular peripheral contour. The internal space is accessible to said surgical fastener that includes at least one body forming a reinforcing section that includes an open ring intended to extend substantially along at least one part of the substantially circular substantially circular peripheral contour. The open ring is connected to an attachment arm that extends substantially radially towards the inside and is intended to be anchored in the abdominal wall.

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: A method is provided for preparing a tissue implant for implantation. The method includes harvesting a tissue material from a human or an animal donor, treating the tissue material in a nuclease-containing solution, and thereafter treating the tissue material with an alkaline alcohol solution. The nuclease-containing solution includes an antimicrobial. The alkaline alcohol solution comprises sodium hydroxide and ethanol.

Abstract: A method for preparing placenta membrane tissue grafts for medical use, includes obtaining a placenta from a subject, cleaning the placenta, separating the chorion tissue from the amniotic membrane, mounting a selected layer of either the chorion tissue or the amniotic membrane onto a drying fixture, dehydrating the selected layer on the drying fixture, and cutting the selected layer into a plurality of tissue grafts. Preferably, the drying fixture includes grooves or raised edges that define the outer contours of each desired tissue graft, after they are cut, and further includes raised or indented logos that emboss the middle area of the tissue grafts during dehydration and that enables an end user to distinguish the top from the bottom side of the graft. The grafts are comprised of single layers of amnion or chorion, multiple layers of amnion or chorion, or multiple layers of a combination of amnion and chorion.

Abstract: Described herein are tissue grafts derived from the placenta. The grafts are composed of at least one layer of amnion tissue where the epithelium layer has been substantially removed in order to expose the basement layer to host cells. By removing the epithelium layer, cells from the host can more readily interact with the cell-adhesion bio-active factors located onto top and within of the basement membrane. Also described herein are methods for making and using the tissue grafts. The laminin structure of amnion tissue is nearly identical to that of native human tissue such as, for example, oral mucosa tissue. This includes high level of laminin-5, a cell adhesion bio-active factor show to bind gingival epithelia-cells, found throughout upper portions of the basement membrane.

Abstract: A neural graft includes a biological substrate, a carbon nanotube structure and a neural network. The carbon nanotube structure is located on the biological substrate. The carbon nanotube structure includes a number of carbon nanotube wires crossed with each other to define a number of pores. The neural network includes a number of neural cell bodies and a number of neurites branched from the neural cell bodies. An effective diameter of each pore is larger than or equal to a diameter of the neural cell body, the neurites substantially extend along the carbon nanotube wires such that the neurites are patterned.

Abstract: Disclosed are tissue graft compositions made of materials having different densities, methods of making, and methods of treatment for restoring tissues in a patient.

Abstract: The present invention provides new methods for the in vitro preparation of bioartificial tissue equivalents and their enhanced integration after implantation in vivo. These methods include submitting a tissue construct to a biomimetic electrical stimulation during cultivation in vitro to improve its structural and functional properties, and/or in vivo, after implantation of the construct, to enhance its integration with host tissue and increase cell survival and functionality. The inventive methods are particularly useful for the production of bioartificial equivalents and/or the repair and replacement of native tissues that contain electrically excitable cells and are subject to electrical stimulation in vivo, such as, for example, cardiac muscle tissue, striated skeletal muscle tissue, smooth muscle tissue, bone, vasculature, and nerve tissue.

Abstract: A bioprosthetic device is provided for soft tissue attachment, reinforcement, and or reconstruction. The device comprises a naturally occurring extracellular matrix portion and a three-dimensional synthetic portion. In illustrated embodiments, the naturally occurring extracellular matrix portion comprises layers of small intestine submucosa, and the three-dimensional synthetic portion comprises a foam or a three-dimensional mesh, textile, or felt.

Abstract: A engineered tissue implant comprising a perfusion chamber formed with a biocompatible flexible tubular member having a wall defining an internal fluid flow passage and a porous scaffold within the fluid flow passage of the tubular member, the porous scaffold arranged such that, in a presence of a perfusion fluid, the perfusion fluid will flow through the porous scaffold and be inhibited from flow between the porous scaffold and the wall of the tubular member. The engineered tissue implant may be understood as a transplantable cell construct or as an implantable bioreactor for cell growth both in vitro and/or in vivo. A method to provide tissue for reconstruction may comprise forming the engineered tissue implant containing a scaffold, introducing and seeding cells to the scaffold, introducing a perfusion fluid to the scaffold which flows through the fluid flow passage and scaffold, proliferating the cells within the scaffold and forming blood vessels within the scaffold.

Abstract: The invention generally relates to devices, systems, and methods for percutaneous closure of cardiac openings and obliteration of the cardiac cul-de-sacs. In one embodiment, a closure device includes a patch with an adhesive and/or a removable frame. The patch may be placed across a cardiac opening, such as a patent foramen ovale, or across a cardiac cul-de-sac, such as a left atrial appendage. In another embodiment, a closure device includes a balloon together with adhesives and/or substances for stimulating tissue growth coated on, or contained within, the balloon. The balloon may be inserted into a cardiac opening, such as the patent foramen ovale, or into a cardiac cul-de-sac, such as a left atrial appendage.

Abstract: A method of disinfecting a biological material provides disposing at least a portion of the biological material in the path of the gas cluster ion beam or in the path of the accelerated neutral beam so as to irradiate at least a portion of the biological material to disinfect the irradiated portion.

Abstract: An implant includes a biocompatible framework material and a biologically-active material. The biologically-active material is embedded in the biocompatible framework material, and a portion of the biologically-active material is exposed to the outside of the implant.

Abstract: Devices and methods for treating an abdominal incision or hernia are described. An implant for the restoration or prophylactic treatment of an abdominal wall comprises an elongate element and at least one sheet connected to the elongate element along a longitudinal axis of the elongate element. The elongate element is positioned along the line of incision, and the at least one sheet is secured to the abdominal muscles surrounding the incision.

Abstract: Described herein are tissue grafts derived from the placenta. The grafts are composed of at least one layer of amnion tissue where the epithelium layer has been substantially removed in order to expose the basement layer to host cells. By removing the epithelium layer, cells from the host can more readily interact with the cell-adhesion bio-active factors located onto top and within of the basement membrane. Also described herein are methods for making and using the tissue grafts. The laminin structure of amnion tissue is nearly identical to that of native human tissue such as, for example, oral mucosa tissue. This includes high level of laminin-5, a cell adhesion bio-active factor show to bind gingival epithelia-cells, found throughout upper portions of the basement membrane.

Abstract: A mammalian tissue scaffold and method for making a tissue scaffold including a rigid scaffold body of biocompatible glass fibers bonded together and in special alignment to define open channels within the scaffold to allow fluid flow into and within the scaffold.

Abstract: A biocompatible, self-supporting, curved, collagen membrane adapted to be secured by bone tacks or bone screws over exposed bone at a desired bone graft site in the alveolar ridge of a patient such that the membrane defines a space having a predetermined height and width over the exposed bone, in which the membrane maintains its structural integrity for at least 4 months after implantation at the bone graft site and then naturally breaks down and is resorbed by the patient's body, a method of making such a membrane, and a method of using such a membrane for vertical augmentation of the alveolar ridge of the patient.

Abstract: A method for preparing placenta membrane tissue grafts for medical use, includes obtaining a placenta from a subject, cleaning the placenta, separating the chorion tissue from the amniotic membrane, mounting a selected layer of either the chorion tissue or the amniotic membrane onto a drying fixture, dehydrating the selected layer on the drying fixture, and cutting the selected layer into a plurality of tissue grafts. Preferably, the drying fixture includes grooves or raised edges that define the outer contours of each desired tissue graft, after they are cut, and further includes raised or indented logos that emboss the middle area of the tissue grafts during dehydration and that enables an end user to distinguish the top from the bottom side of the graft. The grafts are comprised of single layers of amnion or chorion, multiple layers of amnion or chorion, or multiple layers of a combination of amnion and chorion.

Abstract: The invention relates to a device composed of a plurality of strips of randomly oriented nanofibers, wherein said strips are arranged along their longitudinal axes. In addition, the surface of the device's nanofibers are covalently modified with fibroblast growth factor-2. A method for using the instant device for facilitating axonal regeneration in spinal cord injury is also provided.